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Biotest AG — Annual Report 2024
Mar 31, 2025
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Annual Report
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TOGETHER. SUSTAINABLE. FIT FOR FUTURE.| Annual Report 2024

KEY FIGURES
| BIOTEST GROUP | 2024 | 2023 | |
|---|---|---|---|
| Revenue | € million | 726.2 | 684.6 |
| thereof: | |||
| Germany | € million | 160.8 | 140.5 |
| Rest of the World | € million | 565.4 | 544.1 |
| EBITDA | € million | 135.1 | 179.4 |
| Depreciation & amortization | € million | 40.6 | 35.9 |
| Operating result (EBIT) | € million | 94.5 | 143.5 |
| EBIT in % of sales | % | 13.0 | 21.0 |
| Profit (loss) before taxes (EBT) | € million | 46.5 | 106.3 |
| Profit (loss) (EAT) | € million | 26.4 | 127.0 |
| Financing | |||
| Cash flow from operating activities | € million | 60.9 | ‐2.7 |
| 31.12.2024 | 31.12.2023 | ||
| Equity | € million | 530.7 | 498.9 |
| Equity ratio | % | 37.0 | 35.4 |
| Total assets | € million | 1,434.0 | 1,410.9 |
| Employees in FTEs | amount | 2,494.9 | 2,426.2 |
| Earnings per ordinary share | € | 0.66 | 3.20 |
CONTENTS

Peter Janssen Chairman of the Board of Management
FOREWORD
Dear Shareholders,
The past financial year was one filled with significant milestones for Biotest. Our progress not only highlights our unwavering com‐ mitment to helping people with severe blood and immune disorders but also reflects our responsibility towards sustainable and forward‐looking development. With our newly developed products, we have made substantial advancements, greatly supported by the close collaboration with our majority shareholder, Grifols, S.A. Through the existing technology transfer and license agreement, these developments have also become key components of the Grifols Group's pipeline. A central pillar of our growth is our expansion program "Biotest Next Level". At our site in Dreieich, we have proactively invested in a substantial expansion of our production capacities. These investments were made not only with an eye on our economic future but also to implement resource‐efficient and sustainable production processes. This enables us to meet the growing demand for life‐saving medications while simultaneously reducing our ecological footprint per product.
Overall, Biotest made another significant step forward on its growth path in 2024. We celebrated a historic success with our immu‐ noglobulin Yimmugo®. Following its successful market launch in several European countries, Yimmugo® became the first product in Biotest's history to receive approval in the United States, the world's largest single market for plasma derivatives. In June 2024, we obtained approval from the U.S. Food and Drug Administration (FDA), which also certified the corresponding production facility. Subsequently, we immediately began producing the quantities required for market entry in the U.S., significantly increasing the capacity utilisation of Biotest Next Level. For the U.S. market launch in 2025, we signed a long‐term agreement with Kedrion Bio‐ pharma for the exclusive marketing and distribution of Yimmugo® in the United States. This partnership is expected to generate over one billion U.S. dollars in revenue over the next seven years, making a substantial contribution to the significant increase in our company's profitability.
In 2024, we laid the foundation for further growth with the successful completion of the phase III study and the submission of marketing authorisation applications for our new Fibrinogen product, manufactured in Dreieich, in key European markets and the USA. Fibrinogen will addressthe significant medical need for additional Fibrinogen in the treatment of acquired fibrinogen deficiency. We expect a decision on the marketing authorisation applications by the end of 2025.
These achievements are also reflected in our operational financial figures. The Biotest Group'srevenuesincreased from € 685 million to € 726 million in the past fiscal year. Earnings before interest and taxes (EBIT) reached € 95 million, compared to € 144 million in the previous year. This decline is due to a lower contribution from the technology transfer and license agreement with Grifols, S.A. in 2024, which was partially offset by the successful commercialisation of the new intravenous immunoglobulin Yimmugo®.
A key raw material for the production of our life‐saving medicines is blood plasma. To ensure a sufficient supply, Biotest opened four new blood plasma donation centres last year, bringing the total to 40 centres across Europe. Without the numerous plasma donors, the production of these life‐saving medicines would not be possible. We extend our deepest gratitude to those who contribute to the healthcare of critically ill patients through their valuable donations.
Biotest will continue to focus on innovation, excellence, and efficiency in the future to sustainably improve the lives of patients. This commitment extends across all areas, from research and development to sustainability management and production. Our clear goal is to obtain approval for new products in an increasing number of countries. The strengthened cooperation with Grifols serves as an additional catalyst in this endeavour. Through collaboration in research and development, valuable knowledge exchange, and the utilisation of Grifols' organisational and production network, we can significantly accelerate our development projects. Furthermore, we are increasing production volumes and expanding our commercial reach.
We are optimistic about the coming years. Our goal is to continue growing, enhance profitability, and firmly embed the principles of sustainability in all business processes. Against this backdrop, we expect a significant growth boost in the next few years, which should lead to a medium‐term increase in revenue to at least € 1 billion. This will also result in a considerable improvement in our product margins. With a clear strategy, innovative solutions, the support of our partners, and the indispensable work of our dedi‐ cated employees, we are well‐prepared to meet the challenges of the future.
We would also like to thank you, our shareholders, for your trust and support. Together, we are working towards a healthy, sustain‐ able and successful future. We would be delighted if you would continue to accompany us on this journey.
Kind regards
Peter Janssen Chairman of the Board of Management
> COMBINED GROUP MANAGEMENT REPORT
| A. | PRINCIPLES OF THE GROUP 9 | ||
|---|---|---|---|
| A.I. | THE GROUP'S BUSINESS MODEL 9 |
||
| A.II. | GROUP STRATEGY 14 | ||
| A.III. | GROUP MANAGEMENT 15 | ||
| A.IV. | RESEARCH AND DEVELOPMENT (GENERAL) 16 | ||
| B. | ECONOMIC AND BUSINESS REPORT 17 | ||
| B.I. | MACROECONOMIC CONDITIONS 17 | ||
| B.II. | INDUSTRY‐SPECIFIC CONDITIONS 18 | ||
| B.III. | BUSINESS PERFORMANCE OF BIOTEST IN 2024 20 | ||
| B.IV. | RESULTS OF OPERATIONS, NET ASSETS AND FINANCIAL POSITION 24 | ||
| B.V. | OVERALL ASSESSMENT OF THE GROUP'S BUSINESS SITUATION 27 |
||
| C. | SUPPLEMENTARY REPORT 28 | ||
| D. | OUTLOOK, RISK AND OPPORTUNITIES REPORT 28 | ||
| D.I. | OUTLOOK REPORT 28 | ||
| D.II. | RISK REPORT 30 | ||
| D.III. | OPPORTUNITIES REPORT 42 | ||
| E. | GROUP DECLARATION PURSUANT TO SECTIONS 315D / 289F HGB 44 | ||
| F. | CONSOLIDATED NON‐FINANCIAL STATEMENT 45 | ||
| G. | TAKEOVER‐RELEVANT INFORMATION PURSUANT TO SECTIONS 315A / 289A HGB 133 | ||
| H. | NOTES TO THE FINANCIAL STATEMENTS OF BIOTEST AKTIENGESELLSCHAFT (HGB) 134 | ||
| H.I. | THE COMPANY'S BUSINESS MODEL 134 |
||
| H.II. | CORPORATE STRUCTURE 134 | ||
| H.III. | HUMAN RESOURCES 135 | ||
| H.IV. | FINANCIAL PERFORMANCE INDICATORS 135 | ||
| H.V. | RESEARCH AND DEVELOPMENT (GENERAL) 135 | ||
| H.VI. | FORECAST‐ACTUAL COMPARISON 135 | ||
| H.VII. | RESULTS OF OPERATIONS, NET ASSETS AND FINANCIAL POSITION 135 | ||
| H.VIII. GENERAL STATEMENT BY THE BOARD OF MANAGEMENT REGARDING ON THE BUSINESS | |||
| SITUATION AS WELL THE EARNINGS; NET ASSETS AND FINANCIAL POSITION 138 | |||
| H.IX. | PROPOSED APPROPRIATION OF EARNINGS 138 | ||
| H.X. | SUPPLEMENTARY REPORT 138 | ||
| H.XI. | FORECAST, RISK AND OPPORTUNITY REPORT OF THE COMPANY 138 | ||
| H.XII. | STATEMENT CONCERNING THE DEPENDENT COMPANY REPORT PURSUANT TO SECTION 312 AKTG 139 |
GROUP MANAGEMENT REPORT FOR THE FINANCIAL YEAR 2024
A. PRINCIPLES OF THE GROUP
A.I. THE GROUP'S BUSINESS MODEL
The Biotest Group (hereafter referred to as "Biotest"), with its registered office in Dreieich, Germany, is an international supplier of biological medicines. Biotest markets its products in Europe, the Middle East, China, Australia, Africa and the USA. Currently distributed products as well as new developments are obtained from human blood plasma or manufactured using biotechnology methods. Clinical Immunology, Haematology, and Intensive Care Medicine are the main therapeutic areas.
The Biotest Group is engaged in research and development in all three therapeutic areas. Biotest covers all the material steps of the value chain, such as preclinical and clinical development of the preparations, plasma collection, production, as well as marketing and sales.
A.I.1 CORPORATE STRUCTURE
The consolidated financial statements include the parent company Biotest AG as well as ten further fully consolidated compa‐nies.
All of Biotest's shareholdings are listed in section F 9 of the notes to the consolidated financial statements. For detailed infor‐mation about the company's corporate structure, management, and governance, please see the "Management declaration", which is available on the company's website at https://www.biotest.com/de/en/investor_relations/corporate_governance_/management_declara‐ tion.cfm.
Grifols, S.A., Barcelona, Spain, a pharmaceutical company in the plasma industry, holds a total of 97.14 % of the voting rights in Biotest AG. At the request of Grifols, S.A., the Regional Court of Frankfurt am Main ruled by order dated 27 October 2022 that the ordinary shares of Biotest AG not already owned by Grifols, S.A., were to be transferred to Grifols, S.A., against payment of compensation. Ac‐ cording to information from Grifols, S.A., an appeal has been lodged in 2023 against the order of the Frankfurt am Main Regional Court, as a consequence of which the shares have not yet been transferred. According to information from Grifols, S.A., the proceedings have not yet been concluded and are currently pending before the German Federal Supreme Court.
A.I.2 PARTNERSHIP WITH GRIFOLS, S.A.
The past 2024 financial year was characterised by close cooperation with the majority shareholder Grifols, S.A. The aim is to work more closely together in the areas of research and development, plasma procurement, production, as well as marketing and sales while main‐ taining the respective independence of Grifols, S.A. and Biotest, and thereby to be able to offer their complementary product portfolios in significantly more countries, exchange knowledge, and provide patients with enhanced accessto life‐saving plasma medicines. Grifols, S.A., and Biotest are thereby joining forces in their core markets in order to strengthen their joint position, ensure greater security of plasma supplies, utilise their respective production capacities and strong research pipelines, and help ensure the availability of plasma products well into the future. This partnership will significantly expand future business opportunities for Biotest.
In order to achieve these strategic objectives, several groundbreaking agreements were signed in 2023 that were also important for 2024. These comprise:
- the disclosure of various Biotest technology components to Grifols, S.A., in return for one‐off payments following full disclosure,
- the rendering of shared development services by Biotest in return for ongoing monthly payments by Grifols, S.A.,
• the future sales‐market‐related licensing of products developed by Biotest in return for licence payments to be rendered at a later date based on the sales proceeds from the licensed products.
• the sale of five Biotest distribution companies in Spain, Brazil, Italy, the United Kingdom and France to Grifols S.A. in return for one‐ time payments. This is also significant in 2024 because the delivery of products to the distribution companies leads to immediate revenue.
All four components help to ensure that Biotest's new product developments can be manufactured and distributed worldwide by re‐ course to the organisation and production network of Grifols, S.A.
A.I.3 THE BIOTEST GROUP'S OPERATING SEGMENTS
The Biotest Group operates within a single business segment that is characterised by a joint production process. All production takes place at the Group's headquarters in Dreieich, Germany. Within this structure, there is only one chief operating decision maker (CODM), which is responsible for the strategic management of the Biotest Group as a whole. All key decisions, including resource allocation, are made by the CODM on the basis of consolidated reports that reflect the entire operating unit. There is no requirement to prepare separate reports for different business areas, as the Board of Management only uses a consolidated income statement for the entire company. This approach highlights the homogeneous structure of the Biotest Group and its focus on an integrated business strategy.
As part of the review of the reporting and control structure of the Biotest Group, a new assessment of the current segment reporting was carried out, which is to be presented in accordance with the requirements of IFRS 8. It was found that the segments reported in the previous financial year 2023 – European Union, Rest of the World and Stateless – do not meet the criteria for operating segments under IFRS 8. As a result, an error correction in accordance with IAS 8 is required, which was made in December 2024. Please refer to the information in the notes to the consolidated financial statements in section C. Segment reporting.
A.I.4 VALUE CREATION
The Biotest Group coversthe main stages of the value chain for the manufacture of its main products, plasma proteins,such as preclinical and clinical development of the preparations, plasma collection, production, as well as worldwide marketing and sales. Most of the production is realised at the German headquarters in Dreieich, Germany, and as part of toll manufacturing agreements at Prothya Bio‐ solutions B.V., Brussels, Belgium, as well as at Human BioPlazma LLC, Gödöllő, Hungary. In addition, Biotest maintains its own marketing and sales operations in three European countries, which are responsible for the distribution of Biotest products in Austria, Switzerland and Hungary. Following the divestiture of Biotest's five sales companies in Spain, Brazil, Italy, Great Britain, and France to Grifols, S.A. in the 2023 financial year, Biotest is now using Grifols' marketing and sales structure in these countries. In Germany, Biotest and Grifols have independent sales teams that collaborate on selected topics. The Biotest Group is also active globally via local partners. The mar‐ keting and sales activities are centrally managed from Biotest's headquarters in Dreieich.
Human blood plasma forms the basis for the manufacturing of distributed Biotest products. To obtain this raw material for its own production as well as for the purposes of selling some of this raw material to contractual partners, Biotest currently oper‐ates 40 of its own collection centresin Germany, Hungary, and the Czech Republic, and hasthereby continued the planned expansion of its own donor centres. In these plasma collection centres, blood is taken from qualified and strictly moni‐tored healthy donors, and the required blood plasma is separated by plasmapheresis. Furthermore, Biotest procures blood plasma from a variety of suppliers. The plasma is further processed into the respective Biotest preparations. In addition, Biotest participates financially with partners in the establishment of further collection centres.
For the expansion of the product range and the increase of manufacturing capacity, Biotest started to plan and implement the Biotest Next Level project in 2013. One focus in the 2024 financial year continued to be the ramp‐up of production at the Biotest Next Level facility. This includes, among other things, the further ramp‐up of the Yimmugo® process, albumin production was started up, the Fibrin‐ ogen validation batches were successfully manufactured and the GMP acceptance inspection of the Fibrinogen plant was carried out by the HLfGP Darmstadt (Hessian State Office for Health and Care).
In mid‐June 2024, the US Food and Drug Administration (FDA) approved the intravenous immunoglobulin Yimmugo® in the USA for the treatment of patients with primary immunodeficiencies (PID). Concurrent with its approval of Yimmugo®, the FDA certified the site in Dreieich, Germany. Biotest hassigned a long‐term agreement with Kedrion Biopharma Inc., Fort Lee (NJ), USA, for the full marketing and distribution of the immunoglobulin Yimmugo® in the USA. The partners are currently preparing the market launch of Yimmugo® in the USA, which is scheduled for 2025.
With Fibrinogen and Trimodulin, two further new plasma proteins are in the advanced development stage.
In February 2024, Biotest successfully completed the phase III trial for the use of Fibrinogen in the acquired fibrinogen deficien‐cy indi‐ cation. The submission for publication in a scientific journal took place in November 2024. Furthermore, Biotest submitted the first application for marketing authorisation for its Fibrinogen in Germany, Austria, and Spain at the end of October 2024. The first marketing authorisation is expected in mid‐2025. The application for marketing authorisation in the USA was submitted to the FDA in December 2024. The commissioning of the production plant for Fibrinogen was completed and acceptance by the Hesse State Office for Health and Care (HLfGP) has been granted. An inspection by the US FDA is expected in mid‐2025.
Biotest has also been conducting two multinational phase III trials with Trimodulin (ESsCAPE and TRICOVID) in the community‐acquired pneumonia (CAP) indication.
In the ESsCAPE study, only patients with severe community‐acquired pneumonia (sCAP) who require invasive mechanical ventilation due to disease severity are being treated. In mid‐2024, an application wassubmitted to the authoritiesto expand the patient population. 62 patients have been treated in this study until the end of December 2024. Biotest expects a later market entry for Trimodulin due to the challenges in patient recruitment for the ESsCAPE Trimodulin study in the phase III.
In the TRICOVID study, patients were treated who already need to be supplied with supplemental oxygen due to their community‐ acquired pneumonia (CAP), but are not yet receiving invasive ventilation. 101 patients have been treated in the study until December 2024. This study will not be continued after February 2025. The data collected so far is an important source of information for the development of Trimodulin.
Biotest is also advancing its development activities in relation to existing products in order to enhance patient care. Acceleration and higher yields in production are what Biotest is striving for in research and development as well as in procurement management and production. To this end, we will continue to focus on selected measures to make processes across all areas of the company even more efficient.
In addition, Biotest is conducting observational studies on its existing products. By the end of 2024, a total of 43 patients were enrolled in the prospective, multi‐centre observational VARIZOSTA trial conducted by Biotest in patients with herpes zoster infection.
With Cytotect®, Biotest is conducting a further international prospective multi‐centre observational study in patients after heart or lung transplantation where a cytomegalovirus infection is suspected (prophylaxis) or has already developed (therapy). A total of 339 patients were included in the international study from January to December 2024. Initial data from the study was pre‐sented at the 30th Inter‐ national Congress of The Transplantation Society (TTS) in Istanbul.
A.I.5 PRODUCT PORTFOLIO
Biotest's product range is divided into the therapeutic areas of Clinical Immunology, Haematology, and Intensive Care Medicine. The portfolio contains products that are already on the market as well as development projects in various phases of product development. The following table provides an overview of the preparations and indications as well as the current development and marketing and sales status.
BIOTEST GROUP'S PRODUCTS AND DEVELOPMENTS
| Product | Lead indication | Status as of 31 December 2024 | |
|---|---|---|---|
| Clinical Immunology therapeutic area | |||
| Cytotect® CP Biotest | Prophylaxis of the clinical manifestation of cytomegalovirus (CMV) infection in patients undergoing immunosuppressive therapy |
Commercialisation in Europe, Asia, South America, Africa, and the Middle East. Marketing authorisation in Thailand. |
|
| Fovepta® | Immunoprophylaxis of hepatitis B in neonates | Commercialisation in Asia, South America, Africa, and the Middle East. |
|
| Hepatect® CP | Prophylaxis of hepatitis B reinfection following liver transplantation as well as immunoprophylaxis of hepatitis B |
Commercialisation in Europe, Africa, Asia, and the Middle East. |
|
| Intratect® 50 g/l (5 %) | Primary immunodeficiency (PID) and secondary antibody deficiency syndromes (SID), autoimmune diseases (including neurological indications CIDP, MMN, GBS, ITP and Kawasaki syndrome)** |
Commercialisation in Europe, South and Central America, Asia, and the Middle East. |
|
| Intratect® 100 g/l (10 %) | PID and SID, autoimmune diseases (including neurological indications CIDP, MMN, GBS, ITP and Kawasaki syndrome)** |
Commercialisation in Europe and the Middle East. | |
| Yimmugo® | EU/Rest of the world: PID and SID, autoimmune diseases (including neurological indications CIDP, MMN, GBS, ITP and Kawasaki syndrome) USA: PID |
Commercialisation in Germany, Austria, and the United Kingdom; distribution agreement with Kedrion for the US market; preparatory activities for market launch in the USA, market authorisations received for the Netherlands, Ireland, Norway, Hungary, and Italy, authorisations expected in three further countries. |
|
| Varitect® CP | Prophylaxis and treatment of varicella zoster virus infection |
Varitect is primarily distributed in Germany, France, Poland, Austria, and Saudi Arabia. |
|
| Zutectra® | Prophylaxis of hepatitis B reinfection following liver transplantation |
Distribution in Europe and Asia as well as further markets in the Middle East. |
|
| Haematology therapeutic area | |||
| Haemoctin® SDH | Haemophilia A (acute therapy and prophylaxis) | Commercialisation in Europe, Asia, and the Middle East; new distribution agreement with SteinCares Group LLC., San José, Escazuù, Costa Rica, a leading speciality medicine company in Latin America, for the distribution of Haemoctin® in selected Latin American countries (Chile, Colombia, Costa Rica, Ecuador, Mexico, and Peru). |
|
| Haemonine® | Haemophilia B (acute therapy and prophylaxis) | Commercialisation in Europe, North Africa, and the Middle East. |
|
| Vihuma® | Haemophilia A (acute therapy and prophylaxis) | Commercialisation in Germany. | |
| Intensive Care Medicine therapeutic area | |||
| Albiomin® (5% and 20%) | Restoration and maintenance of the circulating blood volume in the case of reduced circulating volume |
Commercialisation in therapy in Europe, South America, China**** and Asia, Africa, and the Middle East; global commercialisation as excipient (pharmaceutical excipient) with focus on Europe. |
|
| Biseco® | Restoration and maintenance of the circulating blood volume in the case of reduced circulating volume |
Commercialisation in Germany, Vietnam, Iraq, and Pakistan. |
|
| Cofact® | Deficiency of coagulation factors | Commercialisation in Germany and Austria. | |
| Fibrinogen* | Congenital fibrinogen deficiency _____ Acquired fibrinogen deficiency |
The results of the AdFIrst phase III registration trial for the treatment of acquired fibrinogen deficiency show that the primary endpoint was met. The |
|
| clinical study report has been finalised. The application for marketing authorisation in Germany, Austria and Spain has been submitted in October 2024. The application for marketing authorisation in the USA was submitted in December 2024. |
|||
| Pentaglobin® | Severe bacterial infection with concomitant use of antibiotics (all countries). Replacement of missing antibodies (immunoglobulins) in patients with severe acquired immunodeficiency (in some countries) |
Commercialisation in Central and South America, Asia, Europe, and the Middle East. |
|
| Trimodulin * | Severe community‐acquired pneumonia (sCAP = severe community‐acquired pneumonia) |
ESsCAPE study (patients with severe community‐ acquired pneumonia requiring invasive mechanical ventilation): The study is in the treatment phase; over 62 patients have already been treated. The |
Community‐acquired pneumonia (CAP = community‐acquired pneumonia) ESsCAPE trial is currently being conducted in 18 countries worldwide. TRICOVID trial (in hospitalised and oxygen‐ dependent patients) with community‐acquired pneumonia (CAP) ***
* Preparations in the development phase (status as of 31 December 2024)
** Chronic inflammatory demyelinating polyneuropathy (CIDP); multifocal motor neuropathy (MMN); secondary immune deficiency (SID); Guillain‐Barré syndrome (GBS); idiopathic throm‐ bocytopenic purpura (ITP); primary immunodeficiency (PID)
*** The study will not be continued after February 2025.
**** China is mentioned separately here because in China, only albumin that is manufactured from US plasma may be sold as a plasma protein.
A.I.6 HUMAN RESOURCES
Change in the number of employees
As of 31 December 2024, Biotest employed 2,495 full‐time equivalents. This represents an increase of 2.8 % compared to 2,426 full‐time equivalents at the end of 2023. The increase is mainly due to the personnel requirements in the new plasma centres and production, especially in the Biotest Next Level plant. As of 31 December 2024, Biotest AG employed 1,648 full‐time equivalents (FTEs) (previous year: 1,588). In the 2024 financial year, 80.0 % of employees worked in Germany (previous year: 78.7 %).
A.I.7 EXTERNAL FACTORS INFLUENCING THE BUSINESS
Biotest's manufacturing facilities for plasma proteins are subject to regulation and approval by the Hesse State Office for Health and Care, Darmstadt, Germany (formerly the Darmstadt Regional Authority), and the Paul Ehrlich Institute (PEI), Langen, Germa‐ny. These authorities also inspect the plants newly built at the Dreieich location as part of the Biotest Next Level project, regu‐larly inspect the current facilities, and issue the necessary manufacturing authorisation for Biotest. Furthermore, regulators in the international environ‐ ment increasingly demand national approval of Biotest manufacturing facilities. In EU member states, plasma proteins are approved through national authorisation procedures, the centralised marketing authorisation procedure or by mutual recognition of national mar‐ keting authorisations. In the international environment, marketing authorisations are issued by the respective national regulator. The Biotest Next Level facility wasinspected by the US Food and Drug Administration (FDA) in December 2023; the Dreieich site was certified in June 2024. The statutory and regulatory requirements for the marketing authorisation of Biotest preparations are subject to routine and event‐driven changes. At the same time, quality requirements and authorisation requirements in the international environment are becoming increasingly stringent. These developments led to costs in relation to approval processes with national and international au‐ thorities in the 2024 reporting year on the same level as the previous year.
In the 2024 financial year, the effects of the post‐pandemic situation were still partially evident in terms of our suppliers' delivery capa‐ bilities. The high inflation rate and cost pressure due to collective labour agreements have led to price increases for many raw materials, consumables, and supplies, as well as for technical parts.
A.II. GROUP STRATEGY
The core element of Biotest's strategy is a clear focus on the development and commercialisation of plasma proteins. In addition to continuing its own research and development work, plasma collection, production, and quality assurance, the company is con‐centrating its approval and marketing activities on further internationalisation and on the diversification of its portfolio. More‐over, the technology disclosure and development services ensure that Biotest's new product developments can be manufac‐tured and distributed worldwide by utilising Grifols' organisation and production network. Biotest continues to expand its existing network of plasma collection centres every year. Any additional plasma required is purchased.
The Biotest Group has been expanding its capacities since 2013 in order to participate in future global market growth. The Biotest Next Level (BNL) production plant expands the product portfolio and doubled fractionation capacities. In the future, five rather than three product lines will be obtained from the raw material plasma, while at the same time increasing yields. This is intended to further strengthen the company's profitability and thereby its competitiveness in markets worldwide in order to lay the foundation for the Group's further profitable growth. In November 2022, the first Biotest Next Level preparation Yimmugo® was approved in the German market and distribution commenced. Yimmugo® received FDA approval in June 2024. The marketing authorisation application covers the primary immunodeficiencies (PID) indication. This is the first product manufactured by Biotest in Dreieich which received FDA ap‐ proval. Biotest immediately started to ramp up production and willstartshipping to the USA in mid‐2025. The market launch isscheduled for mid‐ 2025. The strategic partner for sales in the USA is Kedrion Biopharma, Inc., Fort Lee (NJ), USA, a global biopharmaceutical company. The strategic distribution agreement with Kedrion is expected to generate in excess of USD 1 billion in revenue for Biotest over a period of seven years. This is the largest commercial agreement that Biotest has entered into since the company was founded.
Biotest is continuing to intensify its efforts to rapidly develop Fibrinogen, which was submitted for marketing authorisation, as well as to rapidly further develop the development product Trimodulin. Both products are produced in the Biotest Next Level production facility. The results of Biotest's two clinical studies, the AdFIrst study in patients with acquired fibrinogen deficiency and the completed phase I/III study (No. 984) in patients with congenital fibrinogen deficiency, form the basis for the approval of Fibrinogen for the treatment of patients with congenital and acquired fibrinogen deficiency. Biotest has submitted the first application for marketing authorisation in Germany, Austria, and Spain. The first marketing authorisation is expected in mid‐2025. The application for marketing authorisation in the USA was submitted to the FDA in December 2024.
Following the takeover by Grifols, S.A., as majority shareholder in April 2022, Biotest intends to expand its business opportuni‐ties and improve the availability of plasma products for patients in the following financial years through closer cooperation with Grifols.
For example, measures such as technology disclosure and development services ensure that Biotest's newly developed products can be manufactured and distributed worldwide by making use of Grifols' organisation and production network. In return, payments were agreed for the disclosed technology components as well as licence payments to be rendered at a later date based on the sales proceeds from the licensed products. In this context, Biotest recognised revenue from technology disclosure and developmentservicesfor Grifols, S.A., in the amount of € 123.1 million in the 2024 financial year (prior‐year period: € 190.1 million).
Further details are provided in section A.IV. Research and development (general) and in section D.III Opportunities report.
A.III.GROUP MANAGEMENT
Biotest utilisesfinancial indicators in order to manage its business. The trendsin such indicatorsinfluence the company's value in various ways. Financial indicators are measured continuously and form part of monthly reporting to the Board of Management. These reports include an analysis of actual figures and their deviations from budgeted and prior‐year figures. Additional specific analyses are prepared as required.
Due to the presentation in millions of euros, rounding differences of +/‐ one decimal place may arise when summing the amountsstated below.
A.III.1 FINANCIAL PERFORMANCE INDICATORS
The financial indicators used to manage the Biotest Group's business performance are shown in the table below:
| KEY FINANCIAL INDICATORS AT GROUP LEVEL ACCORDING TO IFRS | |
|---|---|
| Indicator | Calculation method | Values as of 2024 | Values as of 2023 |
|---|---|---|---|
| Revenue in € million | See statement of income | 726.2 | 684.6 |
| EBIT operating result in € million | See statement of income | 94.5 | 143.5 |
| Adjusted EBIT in € million | EBIT less expenses for exceptional items | 64.5 | 9.8 |
| EBITDA in € million | EBIT + depreciation + amortization | 135.1 | 179.4 |
| Return on Capital Employed (ROCE) | EBIT/capital employed* | 7.9% | 12.3% |
| EBIT margin | EBIT/revenue | 13.0% | 21.0% |
| EBT margin | EBT/revenue | 6.4% | 15.5% |
| Gross margin | (Revenue ./. cost of sales)/revenue | 30.8% | 40.9% |
| Cash flow from operating activities in € million | See cash flow statement | 60.9 | –2.7 |
| Cost of sales ratio | Cost of sales/revenue | 69.2% | 59.1% |
* Capital employed is defined as total assets less the following items: liquid funds, medium‐ and long‐term investments of funds, prepaid expenses, deferred taxes and trade payables.
The most important performance indicators are revenue and the operating result, in other words, profit or loss before taxes, the financial result, and the result from joint ventures(EBIT). This class of key performance indicators also includesreturn on capital employed (ROCE), cash flow from operating activities, and adjusted EBIT as additional performance indicators.
| ADJUSTED EBIT | ||
|---|---|---|
| in € million | 2024 | 2023 |
| EBIT | 94.5 | 143.5 |
| Earnings from technology disclosure | ‐84.3 | ‐153.5 |
| Disposal gain from sale of five subsidiaries | 0.0 | ‐23.1 |
| Earnings from development services | ‐5.0 | ‐4.7 |
| Expenses for Biotest Next Level | 59.3 | 47.6 |
| Adjusted EBIT | 64.5 | 9.8 |
The expenses for Biotest Next Level include cost of sales amounting to € 50.1 million (prior‐year period: € 32.8 million) and development services costs amounting to € 9.2 million (prior‐ year period: € 14.8 million). The previous year's figures for development services costs were corrected from € 46.6 million to € 14.8 million.
In order to ensure continuity and comparability, expenses encompassing the Biotest Next Level production facility and the Biotest Next Level research and development portfolio are recognised as one‐off effects in the 2024 financial year, as in previous years.
Adjusted EBIT describes the Biotest Group's operating performance excluding exceptional items. This metric is an alternative perfor‐ mance measure (APM) that is not defined in IFRS (International Financial Reporting Standards). In order to ensure continuity and com‐ parability, the expenses of € 59.3 million (prior‐year period: € 47.6 million) from the Biotest Next Level expansion project, which include the Biotest Next Level production facility and the Biotest Next Level research and development portfolio not recharged to Grifols, are recognised as one‐off effects in the 2024 financial year, as in previous years. Furthermore, one‐off effects in the 2024 financial year relate to income of € 84.3 million (prior‐year period: € 153.5 million) from technology disclosure and from € 5.0 million (prior‐year period: € 4.7 million) development services generated with Grifols, S.A. In the previous year, research and development costs of € 31.8 million were recognized twice in "Expenses for Biotest Next Level" and in "Earnings from development services". The previous year's figures have been corrected accordingly.
The respective share that Biotest holds in the total market as well as in a specific market segment represents an important indicator in the sales area. In addition, the structure of receivables as well as their associated risks are continuously analysed. Inventories and changes in receivables are measured and verified on a monthly basis.
A.III.2 NON‐FINANCIAL INDICATORS
Non‐financial lindicators within the overall company are referred to particularly in the production area and in plasma collection, and relate to capacity utilisation levels, processing times and downtimes, quality parameters, as well as the level of inventories along the production chain and yield per unit volume of plasma.
A.III.3 MANAGEMENT OF R&D PROJECTS
Regular portfolio analysis is performed for the management of research and development projects. Reference is made to devel‐opment timelines, costs, probabilities of success, risks, strategic importance, and market size as well as commercial potential, including in the form of a net present value analysis. This portfolio analysis ensures Group‐wide prioritisation of projects and thereby an organisational focus on strategically important projects.
A.IV.RESEARCH AND DEVELOPMENT (GENERAL)
As part of the corporate strategy, research and development, among other areas, form the basis for the Biotest Group's future growth. The ongoing development of existing products and the development of new products enables considerable potential to be tapped in this area.
The focus of research and development projects is on plasma proteins. At present, research activities are focussed on the new products Fibrinogen and Trimodulin, and are to be rapidly developed further and readied for distribution authorisation. Together with Yimmugo®, these form the core of the product portfolio intended for manufacture in the Biotest Next Level production facility.
In addition, existing products are also being systematically developed to further enhance patient benefits or to achieve new indications and approvals in additional countries. As part of a life cycle management project, Biotest is developing an autoinjec‐tor as a new form of application for Zutectra®. Moreover, Biotest will collect further data for its distributed products in three ongoing non‐interventional trials (NIS). The non‐interventional trials serve to continue the investigation of safety and efficacy in large patient populations and to gain further knowledge under everyday conditions, such as on quality of life, treatment course, and application behaviour.
A technology transfer and licensing agreement signed with Grifols will also ensure that Biotest's new product developments (Yimmugo®, Fibrinogen, and Trimodulin) can be manufactured and distributed worldwide by making use of Grifols' organisation and production network. Kedrion Biopharma Inc., Fort Lee (NJ), USA, was selected as the distribution partner for Yimmugo® in the USA.
A list of the progress made on research and development projects in 2024 is presented in the "Research and development" section of the economic and business report.
The Biotest Group'sresearch and development costs amounted to € 56.8 million in the 2024 financial year, and were thereby lower than the previous year's level of € 66.8 million. At 7.8 % of revenue, the share of expenses was below the level of the previous year (9.8 %). In the financial year 2024, development costs of € 3.0 million (previous year: € 0.0 million) were capitalised as internally generated in‐ tangible assets, which corresponds to 5.3 % (previous year: 0.0 %) of the research and development costs. The main reason for the decline in research and development costs was a cost reimbursement of € 9.4 million (previous year: € 3.0 million) as part of accelerated development activities resulting from the collaboration with Grifols, S.A. In addition, lower expenses for the development projects Tri‐ modulin and Fibrinogen contributed to the cost reduction. An offsetting effect resulted from the income from a grant from the Federal Ministry of Education and Research (BMBF) in the first half of 2023. This BMBF grant expired in June 2023, as a consequence of which no expense‐reducing effect arose in the 2024 financial year (prior‐year period: € 8.0 million). In the 2024 financial year, research allow‐ ancesin accordance with the Research Allowance Act (FZulG) grant amounting to € 0.2 million were recognized (previous year: € 0.1 mil‐ lion)
The number of employees engaged in research and development (converted to full‐time equivalents/FTEs) was 219 FTEs as of 31 De‐ cember 2024 compared to 232 FTEs as of 31 December 2023.
B. ECONOMIC AND BUSINESS REPORT
B.I. MACROECONOMIC CONDITIONS
According to the economic report by the Kiel Institute for the World Economy (IfW), the German economy remained stagnant in 2024. The signs of recovery that were still evident in the first half of 2024 failed to consolidate as the year progressed. Uncertainty regarding the direction of German economic policy had a burdensome impact on the willingness to invest and the consumer climate, while em‐ ployment fell noticeably in the second half of the year. While the manufacturing industry continued to shrink, only the service sector recorded an upward trend. In December 2024, the IfW forecasts that Germany's gross domestic product (GDP) will grow by ‐0.2 % for the year as a whole (2023: ‐0.3 %, 2024: ‐0.2 %, 2025: 0.0 %, 2026: 0.9 %)1
According to the IfW, there are many indications that the weakness of the economy is structural and less due to cyclical fluctuations, which limits the short‐term growth prospects. The provisional budget, which remains in place in the first months of 2025 as a result of the coalition break, could also slow economic growth, although the impact is likely to be limited. The situation could also worsen in the coming year if the new US government implements some of its protectionist plans and exports fall further as a result.
According to the IfW, the weak economic phase continued in the eurozone in 2024. Accordingly, economic output stagnated due to the high cost of living, unfavorable financing conditions and a weak external economic environment. Accordingly, the IfW forecasts an in‐ crease in GDP of 0.8 % for 2024 (2023: 0.5 %, 2025: 0.9 %, 2026: 1.1 %).2 Economic development in the eurozone is expected to be similarly subdued in 2025 as in 2024, with GDP growth of 0.9 %. At the same time, inflation is expected to remain at 2.3 %, the same level as the previous year.3
After overall economic production in the UK rose significantly in the first half of the year, growth stagnated in the second half of the year, mainly due to weak momentum in the service sector. The IfW is therefore forecasting a slight increase in growth for the UK in 2024 (2023: 0.3 %, 2024: 0.9 %, 2025: 1.4 %, 2026: 1.4 %).4
According to the IfW, the global economy was characterized by weak momentum in the 2024 financial year. In addition, there was considerable economic policy uncertainty due to geopolitical and trade conflicts as well as the announcements of the future US admin‐ istration. Against this backdrop, the IfW expects global production to grow by 3.2 % in 2024. While the US economy continued to expand significantly, other industrialized nations performed worse and dampened global growth. The emerging markets continued to develop unevenly. The weak momentum of the Chinese economy slowed the increase in overall production, while production growth in South East Asia, particularly in India, also weakened.5
In view of strong growth in construction investment, which was boosted by extensive support programs from the US government, as well as growing private consumption, the US economy could grow by 2.8 % in 2024, according to the IfW. However, according to the IfW, economic momentum is likely to weaken again due to subdued sentiment in the corporate sector and slowing momentum on the labour market, meaning that GDP in the United States is only forecast to reach 2.in 2025 (2023: 2.9 %, 2024: 2.8 %, 2025: 2.4 %, 2026: 1.7 %).6
In the advanced economies of Asia, overall economic production increased significantly, driven by new government economic stimulus programs, including those to promote the chip and AI industry in Japan. 7 Accordingly, the IfW is forecasting clearly positive GDP growth of 4.0 % for Asia as a whole in 2024 (2023: 3.4 %, 2024: 4.0 %, 2025: 3.9 %, 2026: 3.8 %).8
4 Kiel Economic Report 119, Global economy in winter 2024, p. 10 5 Kiel Economic Report 119, Global economy in winter 2024
1 Kiel Economic Report 120, Global economy in winter 2024, p. 4
2 Kiel Economic Report 119, Global economy in winter 2024
3 https://www.ifw‐kiel.de/de/themendossiers/konjunktur/#m‐tab‐0‐welt.
6 Kiel Economic Report 119, Global economy in winter 2024, p. 10
7 Kiel Economic Report 119, Global economy in winter 2024 p.10
8 Kiel Economic Report 119, Global economy in winter 2024, p. 9
After growth of 1.8 % in 2024, economic forecasts for Latin America predict a further increase in growth momentum in the following year (2023: 2.2 %, 2024: 1.8 %, 2025: 2.5 %, 2026: 2.1 %). This is primarily due to an increase in production in the major Latin American economies.9
The Kiel Institute for the World Economy also predicts more dynamic growth for Africa in the coming years (2023: 3.1 %, 2024: 3.3 %, 2025: 3.7 %, 2026: 3.8 %). South Africa will lag behind other countries such as Egypt, Nigeria and Algeria, with growth of between 0.5 and 1.2 % in the next few years.10
An increase in growth is expected in the Middle East and Central Asia (2023: 2.0 %, 2024: 2.4 %, 2025: 3.6 %, 2026: 3.9 %), but to a lesser extent than forecast in October. This is mainly due to a revision of the growth forecasts for Saudi Arabia, where a reduction of 1.3 percentage points has been made by 2025. The main reason for this is the extended production cuts by OPEC+.11
There are major differencesin the development of healthcare expenditure in the Biotest Group'starget markets. According to the OECD, the USA led the way in 2023 with healthcare expenditure of USD 13,432 per capita, followed by Switzerland with USD 9,688 per capita and Germany with USD 8,440 per capita.12 In the USA, healthcare expenditure of USD 144 billion was planned for 2024, while the US Department of Health and Human Services' budget proposal for 2025 is USD 131 billion.13 In the EU, up to € 5.3 billion is to be invested to strengthen national healthcare systems between 2021 and 2027 as part of the EU4health program.14 In Germany the healthcare budget has shrunk: after € 24.48 billion was still available to the Ministry of Health in 2023, healthcare expenditure of just € 16.22 billion was budgeted for 2024.15
Due to the high global medical demand for plasma protein products, the Biotest Group is generally only slightly dependent on global economic cycles. This management assessment also appliesin the current economic environment. Nevertheless, effects on the operating business, in particular from local crises, the wars in Ukraine and the Middle East, an interruption to supply chains and exchange rate changes, cannot be ruled out.
B.II. INDUSTRY‐SPECIFIC CONDITIONS
B.II.1 IMMUNOGLOBULINS AND ALBUMIN
The Biotest Group is active in global markets for immunoglobulins and albumin, which generated the strongest revenue of the product range in the past financial year. Established markets in Europe as well as further global markets are continuing to contribute to the positive trend in the overall market.
The long‐term growth of the global albumin market is estimated in the mid‐single‐digit percentage range. The Chinese market plays an important role here and is expected to continue its above‐average growth in the future.16 Worldwide, Asian markets account for 60 to 70 % of global sales of human albumin, whereby China accounts for the largest share. The price trend for albumin was positive in 2024.17
For the immunoglobulin (IgG) market, sector experts expect the long‐term target range to reflect annual global demand growth in the mid‐single‐digit percentage range.18
In the USA, the lgG volume in the six months to June 2024 grew in the lower double‐digit percentage range year‐on‐year.19 In Europe, by contrast, the market volume for immunoglobulins only achieved growth in the mid‐single‐digit percentage range in the same period.20 In the first three quarters of 2024, the German IVIG market, which is important for Biotest, grew at a low double‐digit percentage rate year‐on‐year.21 Prices for intravenous immunoglobulins (IVIG) in the EU immunoglobulins market are below the price level in the USA on average, while globally the average price was on a positive trend in the first half of 2024.22 Prices for IVIG in the USA in the first six months of 2024 rose by a low double‐digit percentage rate compared with 2023.23 On a full‐year view, however, the price trend for
- 9 Kiel Economic Report 119, Global economy in winter 2024, p. 9
- 10 Kieler Konjunkturbericht 119, German economy in Winter 2024, p. 14
-
11 World Economic Outlook Global Growth: Divergent and Uncertain, January 2025, p. 4
-
13 HHS FY 2025 Budget in Brief, online at https://www.hhs.gov/about/budget/fy2025/index.html
- 14 European Commission, EU4Health program 2021‐2027, online at: https://health.ec.europa.eu/funding/eu4health‐programme‐2021‐2027‐vision‐healthier‐european‐union_en
- 15 German Bundestag, Budget 2024: Health budget shrinks by a third, online at: https://www.bundestag.de/presse/hib/kurzmeldungen‐987072
- 16 MRB (2024)
- 17 Biotest in‐house data
- 18 MRB (2024)
- 19 PPTA North America Data Program (2024)
- 20 IQVIA (2024)
- 21 Biotest in‐house analysis based on Insight Health, IQVIA 2024
22 IQVIA (2024), CMS.gov.
23 CMS.gov.
12 OECD Data Explorer, (Topic: Health, Parameter: All Expenditures, Per Person in USD, All Functions, All Financing Schemes) online via https://data‐explorer.oecd.org/
intravenous immunoglobulins is negative and the pressure on market prices is steadily increasing (such as from the National Framework Agreement for immunoglobulins in the UK).
B.II.2 HAEMOPHILIA
The treatment of haemophilia A is increasingly characterised by non‐factor replacement therapies in addition to the use of recombinant factor VIII preparations. Numerous alternative treatments make competition more intense and keep price pressure high in the overall market. Further alternative therapies are expected to be approved in the coming years.
New therapeutic options are restraining the growth of the factor VIII market, particularly in the USA, Europe, and other developed markets. Only in emerging marketsis growth in the low to mid‐single‐digit percentage range still expected due to increasingly established factor VIII therapies.24 In many of these countries, haemophilia patients currently do not have access to coagulation factor therapy. While Europe and North and South America account for only around 28 % of the world's population, they account for around 79 % of the global factor VIII market volume.25
In August 2022, the first gene therapy for the treatment of haemophilia A received marketing authorisation from the EMA (European Medicines Agency). This therapy promises to eliminate the need for traditional treatments for several years. Although the population of suitable patients is limited and the market penetration of this therapy to date has fallen well short of expectations, this will place further pressure on developed factor VIII markets and further strengthen the importance of markets outside the USA and Europe. The global market is projected to diminish at a single‐digit negative percentage rate in terms of volumes of plasmatic factor VIII preparations. The volume decrease is expected to be particularly significant in the USA, the largest market for haemophilia preparations, and in the Euro‐ pean market, which is important for Biotest. Volume growth rates in the low single‐digit percentage range are expected only in some emerging markets.26 The simultaneous decrease in prices for plasmatic factor VIII preparations in developed markets and the shift of the market to lower‐priced emerging markets led to a negative trend in the low‐single‐digit percentage range in sales revenue of plasmatic factor VIII products.
B.II.3 SPECIAL PRODUCTS
The Biotest Group has products in its special portfolio that are used in various transplantations.
The number of transplantations grew at a mid‐single digit year‐on‐year rate up until October 2024, on the basis of report submitted to Eurotransplant. Based on market observations, Biotest assumesthat the number of transplantations will continue to grow at a moderate rate.
For Biotest, this applies in particular to the products Cytotect®, Hepatect®, and Zutectra®. The former is generally used afterstem cell and solid organ transplantations, and especially after heart and lung transplantations. Hepatect® and Zutectra® are used in the area of liver transplantation due to hepatitis B infection. While the number of liver transplants is growing at a mid‐single‐digit rate globally,27 the incidence of hepatitis B (HBV) is expected to decrease at the same time thanks to numerous efforts at both global and national level.28 As a consequence, an increase in hepatitis B virus‐related liver transplants in the low single‐digit percentage range is anticipated.
The number of stem cell transplants, which is also relevant for Cytotect®, has been growing continuously over the last thirty years, with the period of the COVID‐19 pandemic representing the only exception. Following a recovery in the number of stem cell transplants in 2021, a stable trend was evident in 2022. The positive long‐term trend is expected to continue in the future.29 By contrast, the entry into the market of innovative antiviral treatments is leading to greater pressure in Cytotect®'s established indications.
The speciality preparation Pentaglobin® is used in the severe bacterial infection indication, with simultaneous use of antibiotics, in other words, in the immediate sepsis environment. Medical demand in the sepsis area remains high. Approximately 47 to 50 million cases of sepsis occur annually, including up to 20 million in children under five years of age. These result in at least 11 million deaths per year worldwide.30 Due to the ageing population and the continued lack of effective treatment options for sepsis, the number of sepsis cases in Germany, France, Italy, Spain and the UK is expected to grow by around one per cent per year.31 At the same time, the incidence of
MRB (2022) WFH Report on the Annual Global Survey 2023 MRB (2022) Transplant Observatory (2024) WHO (2023) EBMT Activity survey, Passweg et al. (2023, 2024) Rudd et al. (2020) Global Data (2024)
multidrug‐resistant infections, ranked by the WHO as one of the "top 10 global public health threats", is rising, thereby increasing the need for supportive care options.32 This is leading to continued high demand for Pentaglobin®.
B.III.BUSINESS PERFORMANCE OF BIOTEST IN 2024
B.III.1 FORECAST‐ACTUAL COMPARISON
For the 2024 financial year, the Board of Management of Biotest AG expected revenue growth in the uppersingle‐digit percentage range compared with 2023. The Biotest Group generated sales of € 726.2 million in the reporting year, compared to € 684.6 million in the previous year. This corresponds to significant revenue growth of 6.1 % (€ 41.6 million). This revenue growth is mainly due to increased sales of products, with Intratect® and Yimmugo® being the most significant sales drivers. The new intravenous immunoglobulin Yim‐ mugo®,sales of which increased by € 34.9 million to € 62.1 million, isthe first commercial preparation to be produced using an innovative manufacturing process at the Biotest Next Level production facility. Yimmugo® was successfully launched on the market in November 2022 and has also been approved in the USA since June 2024.
Revenue from technology disclosure and development services for Grifols, S.A. declined from € 190.1 million in the same period of the previous year to € 123.1 million in the financial year.
The consolidated EBIT result fell to € 94.5 million in the 2024 financial year after € 143.5 million in the previous year. EBIT of between € 80 million and € 100 million was expected. Accordingly, the EBIT of € 94.5 million achieved is at the upper end of the forecast range. On the one hand, this development was due to the one‐off effect of the gain on disposal of five Biotest subsidiaries in the amount of € 23.1 million in the previous year. In addition, the reduced sales from technology disclosure and development services for Grifols, S.A. and the resulting € 68.9 million drop in earnings had a diminishing impact on EBIT.
The Biotest Group's core business (adjusted EBIT) amounted to € 64.5 million in the past financial year. The forecast was € 65 to 85 mil‐ lion.
Furthermore, the Board of Management expects a slightly improved return on capital employed (ROCE) for 2024 compared to the 2023 financial year. ROCE amounted to 7.9 % for the 2024 financial year after 12.3 % in 2023. This development is mainly due to the forecast decline in EBIT, while capital employed remained at a similar level to the previous year.
At the start of the financial year, cash flow from operating activities was forecast to be positive and well above the level of the previous year. With a positive cash flow from operating activities of € 60.9 million (year‐on‐year: €‐2.7 million), the forecast was confirmed in full. The main reason for this was the significantly improved cash flow from the change in working capital.
B.III.2 FURTHER EVENTS IN THE COURSE OF BUSINESS
Annual General Meeting
The Annual General Meeting 2024 of Biotest AG was held on 7 May 2024 with physical attendance again after the pandemic years. Seven out of nine items on the agenda were submitted to the vote at the Annual General Meeting. The shareholders of Biotest AG approved all items on the agenda with a large majority in accordance with the management's proposals. The actions of the members of the Board of Management and of the Supervisory Board for the 2023 financial year were approved by a large majority.
Personnel changes on the Supervisory Board
At the Annual General Meeting 2023, Mr Javier Llunell Colera was also elected by a large majority as a substitute member for Mr. Raimon Grifols Roura. Mr. Javier Llunell Colera stepped down from his position as a substitute member of the Supervisory Board on 17 March 2024. Ms. Uta Kemmerich‐Keil stepped down from office on 30 September 2024. Prof. Dr. Gernot Hebestreit was court‐appointed as her successor with effect from 28 November 2024.
Personnel changes on the Board of Management
Mr. Peter Janssen was appointed Chairman of the Board of Management (CEO) of Biotest AG with effect from 1 January 2024. Mr. Janssen has been a member of the Board of Management since 2022.
Dr. Jörg Schüttrumpf stepped down from his position as Chief Scientific Officer and as a member of the Board of Management of Biotest AG with effect as of 31 August. In future, he will concentrate on his role as Chief Scientific Innovation Officer for the entire Grifols Group.
On 14 September 2024, Mr. Martin Möller was appointed as interim Chief Financial Officer for six‐month period until 15 March 2025. He succeeds Ms. Ainhoa Mendizabal Zubiaga, who has worked for Biotest AG as Chief Financial Officer since 15 February 2023.
B.III.3 GROUP BUSINESS STRATEGY AND IMPLEMENTATION IN THE FINANCIAL YEAR 2024
Internationalisation
The Biotest Group is active in more than 60 countries. In the 2024 financial year, the Biotest Group opened up new countries through additional marketing authorisations and thereby further strengthened its international alignment. Among other marketing authorisa‐ tions, Cytotect® was approved in Thailand in the 2024 financial year. Yimmugo® was approved by the US Food and Drug Administration (FDA) for distribution in the USA in mid‐2024 and its market launch isin preparation. An MRP procedure (Mutual Recognition Procedure) with Yimmugo® has been successfully completed in eight further European countries. In the financial year 2024, Yimmugo® was author‐ ised in Italy, Norway, Ireland, Hungary and the Netherlands.
Partnerships
In 2020, Biotest entered into a collaboration with a partner in order to invest in the future establishment of plasma centres. The first payments toward establishing new plasma centres were rendered to the partner in 2021. In 2022, Biotest entered into a second coop‐ eration with a further partner in order to continue with the strategy. As part of the first partnership, Biotest invested in the establishment of further plasma centres in the same year. As a consequence, several plasma centres have been established from which Biotest is or will be exclusively supplied.
In addition, Biotest has long‐standing partnerships with Prothya Biosolutions Belgium, Brussels, Belgium, and with Human BioPlazma LLC, Gödöllő, Hungary, in relation to fractionation and production.
In 2023, Biotest signed several groundbreaking contracts with Grifols, S.A., Barcelona, Spain, which were also of significance for 2024. They include: the disclosure of various technology components of Biotest to Grifols, S.A., in return for one‐off payments after full disclo‐ sure, the provision of jointly usable development services by Biotest in return for ongoing monthly payments by Grifols, S.A., and the future sales‐market‐related licensing of the products developed by Biotest in return for licence payments to be rendered later on the basis of the sales revenues generated by the licensed products. All three components help to ensure that Biotest's new product devel‐ opments can be manufactured and distributed worldwide by using the organisation and production network of Grifols, S.A.
The strategic partner for sales of Yimmugo® in the USA is Kedrion Biopharma, Inc., Fort Lee (NJ), USA, a global biopharmaceutical com‐ pany. The strategic distribution agreement with Kedrion is expected to generate in excess of USD 1 billion in revenue for Biotest over a period of seven years. This is the largest commercial agreement that Biotest has entered into since the company was founded.
In Latin America, Biotest has signed a new distribution agreement for the distribution of Haemoctin® in selected countries (Chile, Colom‐ bia, Costa Rica, Ecuador, Mexico, and Peru). The distribution partner is SteinCares Group LLC, San José, Escazú, Costa Rica, a leading company for specialised medicine in Latin America.
B.III.4 RESEARCH & DEVELOPMENT
| Study | Number of study participants |
Status as of 31 December 2024 |
|
|---|---|---|---|
| 991 | Multiple dosing, 12‐month treatment duration |
67 | Biotest received the first marketing authorisation for Yimmugo® in Germany in November 2022. Further authorisations followed in Austria, the UK, Norway, Italy, the Netherlands, Hungary, Ireland, and the USA. |
| 992 | Multiple dosing | 34 | Biotest received the first marketing distribution authorisation for Yimmugo® in Germany in November 2022. Further authorisations followed in Austria, the UK, Norway, Italy, the Netherlands, Hungary, and Ireland. |
| 984 | Phase I: single dose for determination of pharmacokinetics, phase III: prevention or treatment of acute haemorrhages |
36 | Study completed. Data from this study and the AdFIrst study form the basis for the submission to the authorities. Biotest has submitted the first application for marketing authorisation for its Fibrinogen in Germany, Austria and Spain. Submission for marketing authorisation in the USA took place in December 2024. |
| 995/ AdFirst |
Treatment for severe blood loss during planned spinal or abdominal tumour surgery. Actively controlled, randomised study comparing frozen fresh plasma or cryoprecipitate |
222 | The results of the phase III study show that the primary endpoint was met. The clinical study report was finalised. Biotest submitted the first marketing authorisation application for its Fibrinogen in Germany, Austria and Spain. The marketing authorisation submission in the US was made in December 2024. |
| 996 | Multiple dosing, placebo‐controlled | 62; approximately 590 planned |
The study is in the treatment phase. The ESsCAPE study is currently being conducted in up to 18 countries worldwide. |
| 1001 | Multiple dosing, placebo‐controlled | 101; approximately 390 planned |
The study was in the treatment phase in 2024.* |
| Phase I/III Congenital fibrinogen deficiency | number Dosage/study design |
* The TRICOVID study will no longer be continued from February 2025.
The focus of research and development projects is on plasma proteins. Research activities in the 2024 financial year concentrated on the new products Fibrinogen and Trimodulin. Alongside Yimmugo®, these form the core for the manufacture of the new product portfolio in the Biotest Next Level production plant.
In the phase III trial (No. 995) relating to acquired fibrinogen deficiency, Biotest already reached a significant milestone in February 2024. The AdFIrst phase III trial has reached its primary endpoint. In this study, the use of Fibrinogen in patients with acquired fibrinogen deficiency during major surgery was shown to be as efficacious as standard treatment in reducing blood loss. The final study report was signed in July 2024 and the positive study results have already been submitted to an international scientific journal for publication. The results of Biotest's two clinical trials, the AdFIrst study and the completed phase I/III trial (No. 984) in patients with congenital fibrinogen deficiency, form the basis for the marketing authorisation of Fibrinogen for the treatment of patients with congenital and acquired fibrinogen deficiency. Biotest has submitted the first application for distribution authorisation for its Fibrinogen in Germany, Austria, and Spain. The first marketing authorisation is expected in mid‐2025. In addition, a filing for Fibrinogen was submitted in the USA at the end of December 2024. Marketing authorisation here is expected at the end of 2025.
The phase III trial 996 (ESsCAPE) with Trimodulin in the severe community‐acquired pneumonia indication (sCAP) is in the recruitment phase. This multinational phase III clinical trial will enrol around 590 adult patients. The ESsCAPE study is being conducted in 18 countries worldwide, including the USA. The sCAP study includes patients who are invasively mechanically ventilated.
Biotest is currently conducting three non‐interventional studies (NISs) on existing products. One NIS is intended to help improve treat‐ ment options for shingles (herpes zoster infection). This study (VARIZOSTA study) will investigate the use of the herpes zoster virus‐ specific hyperimmunoglobulin Varitect® CP in complex herpes zoster infection, especially in patients with a high risk constellation for a severe course of the disease. Biotest is conducting an international, multicentre observational study for Cytotect® in patients after heart or lung transplantation. This study documents patients in whom a cytomegalovirus infection is suspected (prophylaxis) or has already developed (therapy). Biotest has expanded its NIS for the documentation of intravenous immunoglobulins (IVIG) from Intratect® 50 g/L and Intratect® 100 g/L to include the new IVIG Yimmugo®.
B.III.5 MARKETING & DISTRIBUTION
The Marketing and Distribution area covers the therapeutic areas of Clinical Immunology, Intensive Care Medicine, and Haematology.
The 2024 financial year saw a continuation of the trend of increasing plasma donations in the USA and Europe that has been evident since 2022. Demand for immunoglobulins (IgG) an albumin remains at a stable high level and is growing globally. The good supply situ‐ ation for plasma for fractionation and the generally improved market availability of end products are currently leading to falling prices for immunoglobulins in previously undersupplied markets.
Clinical immunology therapeutic area
Revenue of € 62.1 million was generated in 2024 in Germany, Austria, and the UK with the intravenous immunoglobulin Yimmugo®, which has been produced at the Biotest Next Level facility in Dreieich since November 2022. Yimmugo® represents an additional treat‐ ment option with vital immunoglobulins and thereby contributes to supply security for Biotest customers. In addition to the German market, Biotest's sales strategy is aimed at establishing Yimmugo® in the US market. To this end, a significant distribution agreement was signed with Kedrion Biopharma, Inc., Fort Lee (NJ), USA. The market launch in the USA is in preparation. Further marketing author‐ isations for Yimmugo® have been granted in the Netherlands, Ireland, Norway, Hungary, Italy, and the USA. Authorisations are also expected in three further countries, Slowenia, Portugal and France.
With the launch of Yimmugo® in Germany as a new immunoglobulin preparation in addition to Intratect®, Biotest is offering German practitioners an additional treatment option, which customers have already taken advantage of. Sales‐supporting communication measures were deployed to advertise the fact that Intratect® patients can also be treated with Yimmugo® in the future. Intratect® posted revenue growth in all other countries. Biotest sells internationally the volumes of Intratect® that are released in Germany; the product is authorised in over 30 countries worldwide in addition to Germany. The total revenue that Biotest generated from IgG preparations grew accordingly in the 2024 financial year.
The hyperimmunoglobulin portfolio with the key products Cytotect®, Hepatect®, and Zutectra® continued to face known challenges in the 2024 financial year, such as globally falling hepatitis B numbers and the increasing pressure of antiviral products as monotherapy.
However, revenue remained at the same level and in some cases even increased year‐on‐year, as for Cytotect® in France, Spain, Italy, Lithuania, and the UK. Cytotect® also received a further marketing authorisation in Thailand in the first half of the 2024 financial year. The market situation for hepatitis B hyperimmunoglobulins (Hepatect®, Zutectra®, and Fovepta®) continues to be difficult due to falling hepatitis B cases in developed markets and a change in treatment behaviour in relation to monotherapy with antiviral drugs. Neverthe‐ less, a revenue trendon the same level was achieved in 2024. Marketsreporting revenue growth for hepatitis B immunoglobulinsinclude Taiwan, Romania, and Turkey.
Intensive Care Medicine therapeutic area
Revenue generated with Pentaglobin® (IgM Preparation) continued on a strong increasing revenue trend in the 2024 financial year. Biotest increased revenue in its home market of Germany thanks to focussed sales work, revenue growth in established markets such as France, India, and Iraq, as well as in new markets such as Colombia and Turkey. Pentaglobin® is a unique product for which no equiv‐ alent alternative exists on the market, and which is experiencing growing demand. Biotest is working on options to boost production capacity, yield, and clinical support for this strategic product, such as with the PEPPER study, a study initiated by Aachen University. At the end of 2024, the first International IgM Symposium was held, which focussed on the challenges of treating sepsis patients and the role of IgM.
Demand for albumin remained high during the 2024 financial year, and sales are primarily limited by production capacity. This is also reflected in the fact that the average price for albumin rose slightly. Biotest is active in the therapeutic and non‐therapeutic areas with Albiomin®, and has strategically allocated albumin to regions. Thanks to increased production capacities and improved supply chain reliability, higher demand was met in various European markets and the bottlenecks that affected other plasma products were avoided. Biotest successfully expanded its albumin business, particularly in Iraq, Oman and Vietnam, thanks to rising global revenue. China is also a relevant and growing market for albumin sales.
In the non‐therapeutic area, human serum albumin (HSA) is used by other companies in their own production. For example, HSA acts as a stabiliser in this context, as a component of cell media and as a carrier protein. Biotest is expanding into the industrial segment by supplying high‐purity albumin for pharmaceutical manufacturing, diagnostics, and vaccine production. This diversification into non‐ther‐ apeutic applications not only provides a stable revenue stream but also reduces exposure to fluctuations in the therapeutic market in the medium term. The albumin business in the non‐therapeutic area failed to report growth due to the loss of a customer in 2024.
Haematology therapeutic area
In the coagulation factor product portfolio, factor IX (Haemoctin® and Haemonine®) remained under pressure in the 2024 financial year due to the intensively competitive situation with recombinant products, and constantly falling prices. Thisresulted in year‐on‐year lower revenue for Haemoctin®, whereas revenue generated from Haemonine® was stable.
B.IV.RESULTS OF OPERATIONS, NET ASSETS AND FINANCIAL POSITION
B.IV.1 RESULTS OF OPERATIONS
The following table summarises the main income statement items.
MAIN INCOME STATEMENT ITEMS OF THE BIOTEST GROUP*
| € million | 2024 | as % of revenue | 2023 | as % of revenue |
|---|---|---|---|---|
| Revenue | 726.2 | 100.0 | 684.6 | 100.0 |
| Cost of sales | –502.4 | –69.2 | –404.3 | –59.1 |
| Marketing and sales costs | –49.9 | –6.9 | –50.4 | –7.4 |
| Administrative expenses | –38.4 | –5.3 | –30.6 | –4.5 |
| Research and development costs | –56.8 | –7.8 | –66.8 | –9.8 |
| Other operating income and expenses | 7.9 | 1.1 | 10.9 | 1.6 |
| Impairment losses and gains (including reversals) on financial assets and contract assets |
7.9 | 1.1 | 0.1 | 0.0 |
| Financial result | –33.9 | –4.7 | –40.0 | –5.8 |
* Expenses are marked with a negative sign.
In the 2024 financial year, the Biotest Group generated revenue of € 726.2 million, which is significantly higher than in the previous year (same period of the previous year: € 684.6 million).
This revenue growth is mainly due to sales of the new intravenous immunoglobulin Yimmugo® amounting to € 62.1 million (same period of the previous year: € 27.2 million), which is produced in the Biotest Next Level production facility at the Dreieich site. Intratect® at € 257.5 million (prior‐year period: € 216.2 million) and Albiomin® at € 73.3 million (prior‐year period: € 67.3 million) and plasma sales at € 17.3 million (prior‐year period: € 0.1 million) also contributed to the increase in sales. Revenue from technology disclosure and devel‐ opment services for Grifols, S.A. in particular declined in the financial year, amounting to € 123.1 million (same period of the previous year: € 190.1 million). This is due to the fact that four out of six technologies were already disclosed in the previous year.
In the 2024 financial year, the cost of sales rose at a faster rate than revenue at 24.3 %, from € 404.3 million to € 502.4 million. Accord‐ ingly, the cost of sales ratio deteriorated overall from 59.1 % to 69.2 %. This effect arises mainly from higher standard manufacturing costs and the lower sales revenues from technology disclosure and development services for Grifols, S.A. in the 2024 financial year.
Marketing and sales costs decreased by 1.0 % year‐on‐year to € 49.9 million in the 2024 financial year (previous year: € 50.4 million). Due to the revenue growth, the share of marketing and sales costs in revenue decreased by 0.5 percentage points from 7.4 % to 6.9 % in the 2024 financial year.
In the 2024 financial year, administrative expenses increased by 25.5 % from € 30.6 million to € 38.4 million. The increase is mainly due to higher expenses for legal advice and insurance. The administrative expense ratio as a percentage of revenue rose from 4.5 % to 5.3 % in the 2024 financial year.
Research and development costs fellsignificantly by 15.0 % to € 56.8 million (previous year: € 66.8 million). The main reason for this was an expense‐reducing reimbursement of € 9.4 million (previous year: € 3.0 million) as part of accelerated development activities resulting from the collaboration with Grifols, S.A. Lower expenses for the Trimodulin and Fibrinogen development projects also contributed to the cost reduction. An offsetting effect resulted from the recognition of a grant from the Federal Ministry of Education and Research (BMBF) in the first half of 2023, which reduced expenses. The BMBF grant expired in June 2023, meaning that no expense‐reducing effect was achieved in the 2024 financial year (same period of the previous year: € 8.1 million). The research allowance in accordance with the Research Allowance Act (FZulG) remained at the same level in the 2024 financial year at € 0.2 million (same period of the previous year: € 0.1 million). Research and development costs as a percentage of revenue in the past financial year amounted to 7.8 % (previous year: 9.8 %).
Other operating income and expenses decreased from € 10.9 million income in the previous year to € 7.9 million income in the 2024 financial year. This development is partly due to the recognition of the disposal gain of € 23.1 million from the sale of five Biotest sub‐ sidiaries in the same period of the previous year. An opposite effect resulted from the income from the reversal of a financial liability in connection with plasma supply contracts in the amount of € 3.8 million.
Impairment losses and gains (including reversals) on financial assets and contract assets are recognised as a separate income statement item within the operating result, applying a uniform measurement and recognition approach. The change in recognition followsthe rules of IAS 1.41 for improved presentation of the results of operations for both the financial year and the comparative period.
For the financial year 2024, EBIT amounted to € 94.5 million after € 143.5 million in the same period of the previous year and has therefore decreased. The year‐on‐year decline in EBIT is primarily due to the lower earnings effect from technology disclosure and de‐ velopment services for Grifols, S.A. amounting to € 89.3 million (same period of the previous year: € 158.2 million). The EBIT margin for 2024 therefore fell to 13.0 % (same period of the previous year: 21.0 %). Adjusted EBIT improved from €9.8 million in the previous year to € 64.5 million. This improvement was due to higher special effects in the previous year, which weighed on the adjusted result. These effects relate to the capital gain on the sale of five Biotest subsidiaries in the amount of € 23.1 million and a higher earnings effect from technology disclosure and development services for Grifols, S.A. in the previous year.
In the 2024 financial year, the financial result improved to € ‐33.9 million compared to € ‐40.0 million in the previous year. This devel‐ opment is primarily due to a decrease in interest expenses of € 11.2 million, which benefited from the partial repayment of existing external financing. Contrary to this positive effect, interest expenses to affiliated companies increased by € 5.7 million, which is attribut‐ able to the utilisation of a credit line at Grifols Worldwide Operations Limited, Dublin, Ireland.
In the financial year 2024, losses of € ‐4.4 million (previous year: profits of € 2.8 million) were recorded as current investment result from the joint venture BioDarou P.J.S. Co. based in Tehran, Iran. In the financial year 2024, the investment in BioDarou was impaired by € 9.7 million, which wasfully recognised in the financial year 2024 under the result from joint ventures. The impairment was determined as part of an impairment test.
The Biotest Group generated total earnings before taxes (EBT) of € 46.5 million, compared to € 106.3 million in the same period of the previous year.
Tax expenses of € 20.2 million were recognized in the 2024 financial year. This corresponds to a change of € 40.8 million compared to the previous year'stax income of € 20.7 million. The development is mainly due to deferred tax income on loss carryforwards, capitalised in the previous year, the utilisation of which was classified as probable in the near future. The deferred tax income in the previous year more than compensated forthe higher income taxesin connection with the earnings effect from technology disclosure and development services for Grifols, S.A. The development of deferred tax expense in fiscal year 2024 is mainly due to the use of loss carryforwards.
The Biotest Group's earnings (EAT) for the 2024 financial year amounted to € 26.4 million after € 127.0 million in the same period of the previous year. This results in earnings per ordinary share of € 0.66 after € 3.20 in the previous year.
KEY EARNINGS FIGURES OF THE BIOTEST GROUP
| € million | 2024 | 2023 | Change in % |
|---|---|---|---|
| EBIT | 94.5 | 143.5 | ‐34% |
| EBT | 46.5 | 106.3 | ‐56% |
| EAT | 26.4 | 127.0 | ‐79% |
B.IV.2 NET ASSETS
Total assets amounted to € 1,434.0 € million as of the 31 December 2024 reporting date, up by € 23.1 million compared to the level of € 1,410.9 million as of 31 December 2023.
Non‐current assets decreased by € 29.9 million to € 624.5 million as of 31 December 2024, compared with € 654.4 million on the previ‐ ous year's balance sheet date. This is mainly due to the reduction of deferred tax assets by € 13.4 million in connection with the utilisa‐ tion of tax loss carryforwards. Another significant effect of € 9.7 million resulted from the impairment of the investment in BioDarou P.J.S. Co.. In addition, property, plant and equipment decreased by € 7.5 million as net depreciation exceeded additions.
Current assets stood at € 809.5 million as of 31 December 2024 and were thereby € 53.0 million higher than the level of € 756.5 million as of 31 December 2023. Among other factors, this change reflects the significant increase in inventories of € 60.4 million in the 2024
financial year. The higher level of inventories serves to secure planned sales in the coming months, in particular for entry into the Amer‐ ican market with the new immunoglobulin Yimmugo®. In addition, trade receivables increased by € 12.7 million in line with the increase in sales. Contract assets decreased by € 15.6 million compared to the previous year, which is attributable to the quantitative decline in inventories from toll manufacturing.
On the equity and liabilities side of the balance sheet (statement of financial position), equity grew by € 31.8 million to € 530.7 million (31 December 2023: € 498.9 million), reflecting the positive result in the financial year under review, which was also positively influenced by actuarial gains. At 37.0 %, the equity ratio was above the previous year's level (31 December 2023: 35.4 %).
In the past financial year,total liabilitiesfell by € 9.6 million to € 903.3 million (31 December 2023: € 912.0 million). Non‐current liabilities amounted to € 743.2 million as of 31 December 2024 (31 December 2023: € 526.7 million). The main reason for this increase is the change in non‐current financial liabilities from € 429.7 million by € 206.2 million to € 635.9 million as of 31 December 2024. This devel‐ opment is due to the reclassification of the loan from Grifols Worldwide Operations Limited from current to non‐current financial liabil‐ ities as a result of the change in maturity due to the prolongation of the financing agreement until 31 December 2026.
In addition, other non‐current provisions increased by € 9.0 million to € 13.8 million as at the reporting date. This increase is due to the reclassification of a provision for charges from the sales business in connection with price moratoriums and mandatory discounts from current to non‐current provisions.
Current liabilities decreased by € 226.2 million to € 160.1 million as at the reporting date (31 December 2023: € 385.3 million). The decrease is mainly due to the reclassification of the loan to non‐current liabilities and the repayment of loans from third parties, as a result of which current financial liabilities fell by € 224.2 million to € 35.9 million.
Trade payables increased by € 10.3 million to € 88.4 million at the end of the financial year due to the reporting date.
Other current liabilities decreased by € 8.9 million to € 14.0 million as of 31 December 2024 due to differences in the delivery of plasma quantities from the plasma swap agreement with Grifols between the financial year and the previous year. In the previous year, Biotest was under‐delivering, which is why Biotest's obligations from the contract were reported under other liabilities. In the 2024 financial year, Biotest claims against Grifols are reported under other receivables.
Other current provisions decreased from € 23.1 million in the previous year to € 18.2 million as of 31 December 2024. The decrease is mainly due to the reclassification described above. Personnel provisions developed in the opposite direction.
The long‐term capital available to the Biotest Group (equity, pension provisions, and long‐term financial liabilities) covered 87.7 % of total assets as of 31 December 2024 (previous year: 72.3 %). Net debt decreased from € 551.5 million to € 535.1 million as of 31 Decem‐ ber 2024.
B.IV.3 FINANCIAL POSITION
On 24 June 2019, Biotestsigned a financing agreement with five‐year term for a volume of € 240.0 million. These fundsserved to finance the further steps towards the commissioning of the Biotest Next Level facility and to finance current assets. This loan was repaid in full in the 2024 financial year.
Operating cash flow before changes in working capital amounted to € 90.1 million (prior‐year period: € 201.7 million). The main reason for the year‐on‐year decline was the € 100.5 million year‐on‐year decrease in earnings after taxes (EAT). The increase in tax expense to € 20.2 million had the opposite effect. This development was further exacerbated by tax income of € 20.7 million in the same period of the previous year, which was mainly due to the utilisation of loss carryforwards. In addition, this change was further strengthened by an earnings effect of € 23.1 million from the deconsolidation of the sold Biotest subsidiaries in Spain, Brazil, Italy, the United Kingdom and France to Grifols, S.A. in the 2023 financial year.
In 2024, interest and taxes paid totalled € ‐29.0 million, compared to € ‐35.9 million in the previous year. Thus, cash flow from operating activities improved significantly year on year from € ‐ 2.7 million to € 60.9 million in the financial year.
Cash flow from changes in working capital improved year on year to € ‐0.2 million, compared with € ‐168.5 million in the previous year. In particular, the increase in inventories as of the reporting date, which amounted to € 60.4 million, was significantly lower than in the previous year (€ 125.3 million). If the increase in inventories in the 2024 financial year is further adjusted for the non‐cash increase in inventories of € 37.7 million, the effect is even more pronounced. In the previous year, the impairment of inventories was reported in the cash flow statement under the inventories item. As of the 2024 financial year, it was reclassified to the item "Write‐up/impairment of inventories", which is included in the operating cash flow before changes in working capital.
Cash flow from investing activities amounted to € ‐ 25.7 million in the 2024 financial year (prior‐year period: € 1.3 million) and is mainly due to payments for investments in non‐current assets. In the previous year, cash flow from investing activities included proceeds from the sale of the shares in the Biotest subsidiaries in Spain, Brazil, Italy, Great Britain, and France to Grifols, S.A. totalling € 35.0 million.
Cash flow from financing activities amounted to € ‐35.4 million in the 2024 financial year (prior‐year period: € ‐6.8 million). The cash outflowsfrom financing activities were incurred mainly for the € 225.0 million repayment of a collateralised external loan, a cash deposit with banks, and the repayment portion of lease liabilities in accordance with IFRS 16. The utilisation of the loan of € 197.0 million from Grifols Worldwide Operations Limited, Dublin, Ireland, a wholly owned subsidiary of Grifols, S.A., only partly compensated for this effect.
Cash and cash equivalents had decreased to € 107.8 million as of the end of the 2024 financial year compared to € 108.1 million as of 31 December 2023.
Financing strategy
The Biotest Group's financing strategy is designed to ensure the Group's liquidity at all times, to create scope for financing growth in the operating business, and to finance all investments. Biotest deploys both equity and debt capital for its financing purposes and aims to achieve a solid and conservatively oriented financing structure. The long‐term target for the equity ratio is 40.0 %. With an equity ratio of 37.0 % as of 31 December 2024, Biotest stands below this target level. This was primarily due to the impact of the Biotest Next Level expansion project on earnings, and the raising of additional debt capital.
Biotest isfinanced by a subordinated shareholder loan from Grifols Biotest Holdings GmbH, Frankfurt am Main, Germany, in the nominal amount of € 290 million, which was extended on 15 March 2024 until 2 January 2030. To cover further financing requirements in 2023, Biotest AG and Grifols Worldwide Operations Limited, Dublin, Ireland, a wholly owned subsidiary of Grifols, S.A., concluded a € 147.0 mil‐ lion financing agreement on 7 March 2023, which was fully utilised in the 2024 financial year. This facility was extended on 20 December 2024 until 31 December 2026. In addition, further financing of € 50.3 million was raised from Grifols Worldwide Operations Limited, Dublin, Ireland, in the fourth quarter of 2024. Furthermore, an external unsecured loan of around € 44.0 million exists that matures in December 2029, as well as an external unsecured loan of € 0.1 million that matures on 31 December 2025. The latter has an automatic renewal component if it is not terminated by 30 September of a given calendar year. In addition, on 20 December 2024 the letter of comfort between Biotest AG and Grifols Worldwide Operations Limited, Dublin, Ireland, a wholly owned subsidary of Grifols, S.A, was issued to secure the liquidity requirements of Biotest AG, which is limited until 31 December 2026.
The equity capital and the long‐term component of the debt financing together are intended to cover non‐current assets. The capital structure is described in sections E 12 and F 5 of the notes to the consolidated financial statements.
In 2024, Biotest AG joined the factoring group agreement of Grifols, S.A., and now has a utilisable limit of € 15 million, up to which receivables can be sold without right of recourse. As of 31 December 2024, € 8.4 million of this volume had been utilised.
B.V. OVERALL ASSESSMENT OF THE GROUP'S BUSINESS SITUATION
Despite the challenging developments in individual markets and the simultaneous focus on future projects, the Biotest Group can look back on a 2024 financial year with increased revenue. The Group's financial position and performance were influenced by increased product sales and the technology transfer and licensing agreement.
The Biotest Group posted revenue growth of 6.1 % to a level of € 726.2 million. This growth was achieved through a significant increase in product sales, whereas sales from technology disclosure and development services for Grifols, S.A. declined. At € 94.5 million, EBIT was clearly positive, although it fell by € 49.0 million compared to the same period in the previous year. The reason for the decline was, one the one hand, the influence of the one‐off effect of the gain on divestiture of five Biotest subsidiariesin the amount of € 23.1 million in the previous year. In addition, the reduced sales from technology disclosure and development services for Grifols, S.A. and the result‐ ing € 68.9 million drop in earnings had a negative impact on EBIT. Cash flow from operating activities improved significantly in the 2024 financial year compared to the previous year, from € ‐2.7 million to € 60.9 million, mainly due to changes in working capital.
The Group is continuing to focus on ramping up the Biotest Next Level production facility in Dreieich. The first Biotest Next Level prepa‐ ration Yimmugo® has been produced there since November 2022, which also received approval for the USA in June 2024, together with FDA certification of the production facilities. Moreover, Biotest is stepping up its efforts to rapidly develop Fibrinogen, which has been submitted for approval, and the development candidate Trimodulin further. Biotest has submitted the first application for distribution authorisation for its Fibrinogen concentrate in Germany, Austria, and Spain. Fibrinogen was also submitted in the USA at the end of December 2024. Marketing authorisation is expected at the end of 2025.
A list of progress made on research and development projects in 2024 is presented in the section "Research and Development" of the economic and business report.
Four new plasma centres were opened in the 2024 financial year. As of the end of the year, Biotest operated 40 of its own collection centresin Europe. At present, no further expansion is planned in the short term. With the establishments of the plasma centresin recent years, combined with plasma purchases from existing partners, the Biotest Group has secured sufficient supplies of its most important raw material – human blood plasma – for the future.
Thanks to the improved financial position and performance, as well as the expansion of production to include Biotest Next Level, the Board of Management regards the Biotest Group's commercial and financial position as positive overall.
C. SUPPLEMENTARY REPORT
Please refer to our comments in section F 12 Events after the reporting date, in the notes to the consolidated financial statements.
D. OUTLOOK, RISK AND OPPORTUNITIES REPORT
D.I. OUTLOOK REPORT
D.I.1 GENERAL STATEMENT BY THE BOARD OF MANAGEMENT REGARDING THE OUTLOOK FOR GROUP PERFORMANCE
Biotest is responding to the increasing demand for plasma protein products in Europe, the United States and many Asian countries by investing heavily in capacities, including the Biotest Next Level production facility.
Over the next few years, product revenue from this new capacity will gradually replace revenue from the technology supply to Grifols, S.A. For the financial year 2025, we expect this change to result in an operating result (EBIT) of between € ‐55.0 million and € ‐75.0 million and an adjusted EBIT of between € ‐30.0 million and € ‐50.0 million.
The special challenges remain the commissioning and scale‐up of the new multi‐product manufacturing facility of Biotest Next Level, as well as the necessary working capital and the continuous supply of human plasma from the US, which serves as the starting material for the production of Yimmugo® for the US market.
D.I.2 DIRECTION OF THE GROUP IN THE 2025 FINANCIAL YEAR
The general orientation of the Biotest Group in the 2025 financial year will not change. Biotest will focus on the plasma protein business and on the ramp‐up ofthe new production facility as a key component of itsstrategy. In close partnership with Grifols, S.A., R&D activities will be continued in important studies. The aim is to achieve marketing authorisation more rapidly with the new developments, not only in Europe but above all also in the USA.
D.I.3 TRENDS IN THE MARKET ENVIRONMENT
Target markets
According to current forecasts, global demand for immunoglobulins isset to grow annually in the mid‐single‐digit percentage range over the coming years.33 These preparations' prices posted a slight uptrend in both Europe and the USA in the first half of the year, but came under pressure towards the year‐end.34
The long‐term growth of the global albumin market is estimated in the mid‐single‐digit percentage range.35
33 MRB (2024)
34 IQVIA (June 2024), www.cms.gov supplemented by Biotest in‐house analyses. UK National Framework Agreement
35 MRB (2024)
The global market is projected to diminish at a single‐digit negative percentage rate in terms of volumes of plasmatic factor VIII prepa‐ rations.36
D.I.4 EXPECTED PERFORMANCE OF THE BIOTEST GROUP
Expected business and results of operations of the Biotest Group
For the 2025 financial year, the Board of Management expects a mid‐single‐digit percentage decline in sales compared to 2024. Sales in in the 2024 financial year were positively influenced by technology disclosure and development services for Grifols, S.A. in the amount of €123.1 million, which will be significantly lower due to the technology disclosure, which has already been completed in full. The ongoing conflict in the Middle East poses significant risks to sales and earnings. Economic instability in the region could have a negative impact on sales and affect earnings.
The Board of Management expects operating earnings (EBIT) in a range between € ‐55.0 million and € ‐75.0 million for 2025. This results from the aforementioned revenue forecast and the corresponding development of production costs. The return on capital employed (ROCE) for the 2025 financial year is expected to be in the range of ‐3% to ‐7%. This development is mainly due to the expected negative operating result (EBIT). Cash flow from operating activities is expected to be in the low, negative triple‐digit millions range. This essen‐ tially follows the operating performance and the development of the net working capital.
Expected financial and net assets position of the Biotest Group
The Biotest Group aims to maintain a balanced financing structure in terms of its ratio of debt to equity, as well as of short‐term to long‐ term credit financing. The Group has used and will continue to use the majority of the cash and cash equivalentsreceived in recent years for the Biotest Next Level project in order to secure the ramp‐up of the new products within the new production facility. Moreover, Biotest has expanded its network of plasma collection centres to ensure the requisite plasma supplies for the new Biotest Next Level production facility, among other objectives. For the 2025 financial year, the Biotest Group plans to invest on a higher level than in the previous year. The major share of capital expenditure will be directed towards the expansion and maintenance of production facilities and infrastructure measures. The investments also include further developments in the area of digitalisation.
Financing in 2024 was mainly being provided by shareholder loans. These shareholder loans and the letter of comfort between Biotest AG and Grifols Worldwide Operations Limited, which is limited Biotest AG and Grifols Worldwide Operations Limited until 31 December 2026, secures the financing required for the ramp‐up of the Biotest Next Level production facility and further development activities.
Biotest expects the following trends in the therapeutic areas:
Haematology therapeutic area
Haemoctin® SDH: The market situation for plasmatic factor VIII/IX products is expected to remain strained in 2025 and price pressure will remain high in the main markets, especially in Germany. In a diminishing market, Biotest intends to sell its coagulation factor prod‐ ucts at economically viable prices in only a few markets.
Haemonine®: For this product as well, Biotest is focusing on maintaining its position in the main markets due to the diminishing market trend.
Vihuma®: In 2025, Biotest will continue to deploy Vihuma®.
Clinical Immunology therapeutic area
Cytotect®: Bone marrow transplants and selected areas of solid organ transplantation will continue to form the main focus for Cytotect® CP Biotest in 2025. The most important markets include the EU countries, the UK, and core Asian markets such as Taiwan. In addition, further distribution authorisation procedures outside Europe are underway.
Intratect® 50 g/l (5%) and Intratect® 100g/l (10%): These preparations are sold in Europe as well as in numerous international markets, such as Switzerland, Jordan, Saudi Arabia, Turkey, and the United Arab Emirates. Biotest will continue to focus on high‐price markets in the coming year.
Yimmugo®: The immunoglobulin preparation Yimmugo® has been manufactured in the Biotest Next Level production facility since No‐ vember 2022. The volumes of Yimmugo® available will increase continuously over the coming years and the distribution strategy will
36 MRB (2022).
focus on strategic markets. The market launch of Yimmugo® with Kedrion Biopharma Inc., Fort Lee (NJ), as distribution partner in the USA is expected in 2025. In addition to the marketing authorisations already received in Germany, Austria, the UK, Norway, the Nether‐ lands, Hungary, Italy, Ireland, and the USA, marketing authorisations in further European countries are expected for 2025.
To strengthen the position of Biotest IgG preparations, many of the future activities will focus on the growth areas of secondary immu‐ nodeficiencies (SIDs) as well as neurological diseases such as chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). Biotest expects significant growth, particularly in Europe.
Hepatect® CP, Zutectra® and Fovepta®: Biotest is the market leader for hepatitis B immunoglobulins. The strategy is to maintain market share in the overall diminishing market segment (post‐transplant prophylaxis), to enter new markets, and to develop other applications and indications (beyond the transplantation strategy).
Intensive Care Medicine therapeutic area
Albiomin®: Biotest is continuing its new communication strategy with the aim of further expanding its positioning in the higher price segment and to differentiate itself from competing products. The aim is to penetrate the Chinese market and focus on the premium segment. In addition, Biotest is planning to continuously expand its non‐therapeutic business with Albumin (excipient).
Pentaglobin®: Pentaglobin® is currently distributed in 33 countries worldwide. Although Biotest will continue to focus on the main mar‐ kets of Germany and Italy as well as other strategic international markets in 2025, medical demand nevertheless remains high, as a consequence of which Biotest is planning further distribution and sales measures to promote sales of the product Pentaglobin® to an even greater extent.
Fibrinogen– congenital fibrinogen deficiency: The phase I/III trial (no. 984) was already completed in 2019. Marketing authorisation for this new generation of Fibrinogen is being sought in conjunction with the development of Fibrinogen – acquired fibrinogen deficiency. Biotest has submitted the first application for marketing authorisation for its Fibrinogen in Germany, Austria, and Spain. The application for distribution authorisation in the USA was submitted in December 2024.
Fibrinogen – acquired fibrinogen deficiency due to high blood loss: The AdFIrst (Adjusted Fibrinogen Replacement Strategy) phase III trial reached its primary endpoint, which was published in February 2024. In this study, the use of Fibrinogen in patients with acquired fibrinogen deficiency during major surgery was shown to be as efficacious as standard treatment in reducing blood loss. The results of Biotest's two clinical trials, the AdFIrst study and the completed phase I/III trial (No. 984) in patients with congenital fibrinogen defi‐ ciency, form the basis for the marketing authorisation of Fibrinogen for the treatment of patients with congenital and acquired fibrino‐ gen deficiency. Biotest submitted the first application for marketing authorisation for its Fibrinogen in Germany, Austria, and Spain in October 2024. The first marketing authorisation is expected in mid‐2025. Scientific publications are also being prepared for both clinical trials and the data have been or will be presented at scientific congresses at the end of 2024 and in 2025.
Trimodulin: Biotest is conducting a phase III trial with Trimodulin in the severe community‐acquired pneumonia (sCAP) indication. Until the end of December 2024, 62 patients have been treated with sCAP in an intensive care unit as part of the phase III ESsCAPE trial. This multinational phase III clinical trial will enrol approximately 590 adult patients with sCAP. The ESsCAPE trial is currently being conducted in up to 18 countries worldwide.
D.II. RISK REPORT
As a globally operating Group in a highly advanced technology area, Biotest is subject to a variety of risk factors that could negatively impact business activities. When and where risks resulting from its business activities or external factors will materialise cannot always be foreseen and could lie partly or completely outside Biotest's control. Revenue and earnings, along with the Group's financial position and cash flows, may be negatively affected. This Risk Report describes the known risks to which Biotest is exposed as a Group. At the same time, it explains how the Group handles such risks and how they are controlled and tracked. An assessment by the Board of Management of the individual risks described is presented below.
D.II.1 RISK STRATEGY
As defined by the Board of Management and the Supervisory Board in their joint risk strategy report, the company may take controlled risksin order to generate prospects for long‐term profitable growth. The risk strategy is aimed at ensuring the Biotest Group's continued existence and at enhancing its value sustainably and systematically. This is also reflected in the Board of Management's forecasts.
D.II.2 RISK MANAGEMENT AND CONTROLLING
Biotest systematically records and evaluates short‐term and long‐term risks. All risks with fundamental implications and a reasonable likelihood of materialising are monitored closely as far as possible. The company's IT‐supported risk management system fulfils the requirements of risk management under stock corporation law. Risk management processes are documented in detail, and the relevant documents are stored in the risk management system.
The objectives of the risk management system that has been established are to identify and assess risks in order to enable management to control measures on the basis of risk. Furthermore, any risks identified are reduced as far as possible by involving external experts, if necessary. Lastly, the risk management system is deployed in order to evaluate the impact on the consolidated financial statements of the identified risks, and to map such risks in the system.
Major potential risks form part of monthly internal reports. In addition, every six months the Risk Management Committee reviews the current risk situation and drafts a detailed risk report that is submitted to the Board of Management. This covers short‐term as well as medium‐ and long‐term risks. The principal risks are discussed regularly with the Supervisory Board and the Audit Committee.
Between meetings of the Risk Management Committee, managers brief the Board of Management on the current risk situation in their respective areas of responsibility. At the same time, the Board of Management is informed of the current risk situation as part of fore‐ casts on how the year will close. In the event of a sudden change in the risk position, the Board of Management is notified immediately and directly.
The internal audit department regularly reviews risk management and risk controlling standards and procedures for appropriateness and efficacy. The last audit was conducted in December 2024.
Biotest has concluded insurance policies in order to limit the financial consequences of liability risks and material damage to plant and machinery. The level of protection afforded by the insurance is reviewed regularly and adjusted where necessary. Synergies with the Grifols Group are also being leveraged in terms of insurance cover.
D.II.3 INTERNAL CONTROL SYSTEMS FOR ACCOUNTING PROCESSES
Biotest has implemented an accounting‐related internal control system that covers all the main business processes at Biotest AG and at all of its subsidiaries. The goal of the accounting‐related internal control system is to ensure with adequate certainty through a series of checks that, despite any risks identified, the consolidated financial statements are prepared in accordance with applicable accounting standards and policies. The relevant guidelines are maintained on the Intranet to which all employees have access. In addition, the internal control system implemented in 2023 in accordance with the Sarbanes‐Oxley Act ("SOX") was expanded to a "full scope ap‐ proach" in 2024, so that the most important internal controls as of the reporting date comply with the standards of the US SOX.
Accounting and reporting at Biotest AG and at all its consolidated subsidiaries is conducted in accordance with stringent schedules and procedures, which set out all the necessary activities in detail.
The main separate financial statements of important Group companies and the consolidated financial statements are prepared using SAP systems. Internal control processes have been established at each Group company through organisational procedures and clear responsibilities, including separation of duties through the dual control principle.
Companies enter data for the consolidated financial statements into a standardised SAP‐based reporting system, whose contents are agreed on a monthly basis by the departments responsible for Group finance and controlling. All of the Group companies' reporting packages are subjected to the controls established in the SAP BPC consolidation software, with any differencesin consolidation processes being analysed and, if necessary, corrected.
Measures undertaken in the preparation of the consolidated financial statements are subject to electronic and manual checks. Further checks at the consolidated financial statement level include target/performance comparisons and analyses of changes in items in the consolidated statement of financial position and the consolidated statement of income.
Access to accounting‐related data is protected by monitoring accessto the company premises (access control) and by password‐secured access authorisations to the IT systems.
Both the separate and the consolidated financial statements are audited predominantly by external auditors.
The internal audit department reviews business processes in all segments and subsidiaries. Its powers, duties, and position within the Group are established in the internal audit guidelines. Audits are conducted in accordance with a risk‐oriented annual internal audit plan prepared by the internal audit function and approved by the Board of Management and the Supervisory Board. The individual audit results are promptly submitted to the Board of Management, the Supervisory Board Chairman, and the chair of the Audit Committee.
The internal audit department also reports in detail to the Board of Management and the Supervisory Board at least once every six months.
D.II.4 INTERNAL CONTROLLING AND RISK MANAGEMENT SYSTEM (UNAUDITED)
The systematic and responsible management of risks and opportunities forms an important part of corporate governance for Biotest AG. Corporate governance functions/processes are implemented in accordance with the "Three Lines" model. The risk management system is based on the IDW 340 (revised version) auditing standard.
At the first level (1st Line), activities (including the management of financial and non‐financial risks) and the deployment of resources are managed in accordance with external and internal requirements. Here, risks are to be prevented as well as recorded and mitigated, and internal controls are to be defined and implemented where they can arise, in other words, at the operational level.
At the second level (2nd Line), the framework for the design of the risk management and compliance management system is set by defining corresponding specifications and frameworks for Biotest to apply in the areas of governance, compliance, systems, and pro‐ cesses.
At the third level (3rd Line), the Internal Audit function monitors the regularity, security, appropriateness, and effectiveness of existing governance, processes, internal controls and risk management particularly by means of independent audits. This is performed as part of the risk‐based annual audit plan or, in individual cases, as part of event‐driven audits during the year.
The Board of Management, the Audit Committee, and the Supervisory Board are informed regularly and on an ad hoc basis, in particular by the corporate governance functions such as Internal Audit, Compliance, and Risk Management, about potential material control weaknesses, the effectiveness and appropriateness of the controls in place, as well as the risk situation. The Board of Management is responsible for the continuous improvement and implementation of an appropriate and effective internal control system and risk man‐ agement system. The monitoring and assessment of the internal control and risk management system, including its effectiveness and appropriateness, is the responsibility of the Audit Committee and the Supervisory Board.
If necessary, measures are initiated in cooperation with the respective managers. The auditor examines the risk early warning system that is integrated into the risk management system in order to determine whether it is fundamentally suitable for identifying at an early stage any risks that might jeopardise the company as a going concern; in addition, the auditor reports to the Audit Committee and the Supervisory Board as part of the audit of the financial statements on any significant weaknesses identified in the accounting‐related internal control and risk managementsystem. Where weaknessesin the internal controlsystem are identified,the Board of Management takes measures to rectify them and continuously improve processes and systems.
As of the reporting date of 31 December 2024, in all material respects no indications exist of an overall inadequacy or ineffectiveness of the internal control and risk management system.
D.II.5 RISK MANAGEMENT SYSTEM FOR FINANCIAL INSTRUMENTS
In areas where it is possible, Biotest deploys derivative financial instruments in order to hedge currency positions. The corre‐sponding contracts are concluded taking due account of defined risk limits. Section F 3 of the notes to the consolidated financial statements contains a detailed description of the risk management system in relation to financial instruments.
D.II.6 RISK ASSESSMENT AND DESCRIPTION OF SIGNIFICANT RISK CATEGORIES
Material risks with an expected value of over € 1 million known to the Biotest Group are described below, together with an assessment of the respective risks by the Board of Management. However, Biotest could be exposed to additional risks and uncertainties that are still unknown or are currently considered minor. These risks could also have an adverse effect on the Biotest Group's net assets, financial position, and results of operations. The order in which the risks below are listed is in no way indicative of the probability of their occur‐ rence.
Biotest distinguishes between short‐term risks, whose occurrence would lead to a divergence from the planning for the current and following financial years, and long‐term risks. The long‐term risks represent a potential divergence from the planned busi‐ness trend over the next ten years. All risks are assessed by multiplying the potential negative impact on the net assets, financial position, and results of operations by their estimated probability of occurrence. A distinction is drawn between the following classifications for the probability of occurrence:
PROBABILITY OF OCCURRENCE
| Probability of occurrence | Remarks |
|---|---|
| 0 ‐ 5 % | Very low |
| 5 ‐ 10 % | Low |
| 10 ‐ 25 % | Moderate |
| 25 ‐ 50 % | High |
| 50 ‐ 75 % | Very high |
| 75 ‐ 100 % | Extremely high |
The classification within the impact classes for Biotest AG is done in six levels:
| Amount of damage | Remarks |
|---|---|
| € 0.2 million | very low |
| € 0.2 million ‐ € 1.0 million | low |
| € 1.0 million ‐ € 2.5 million | moderate |
| € 2.5 million ‐ € 5.0 million | substantial |
| € 5.0 million ‐ € 20.0 million | difficult |
| € 20.0 million ‐ € 50.0 million | very difficult |
As far as short‐term risks are concerned, the combination of the probability of occurrence and the financial effects on Biotest's earnings after tax (EAT) leads to the risk matrix shown below, which presents the derivation of the risk assessment.
| Probability of occurrence | |||||||
|---|---|---|---|---|---|---|---|
| Level of damage | Very low | Low | Moder‐ ate |
High | Very high | Ex‐ tremely high |
|
| > € 20.0 million | M | H | VH | VH | VH | VH | |
| € 5.0 to 20.0 million | M | M | H | VH | VH | VH | |
| € 2.5 to 5.0 million | L | M | M | H | H | VH | |
| € 1.0 to 2.5 million | VL | L | M | M | H | H | |
| € 0.2 to 1.0 million | VL | VL | L | M | M | M | |
| € 0.0 to 0.2 million | VL | VL | VL | L | L | L | |
| VL = very low risk, L = low risk, M = moderate risk, H = high risk, VH = very high risk |
Insofar as risk‐limiting measures have been taken, the remaining risk is presented by taking the measures implemented or initiated and most likely to be implemented in the respective forecast period into consideration.
All long‐term and all short‐term risks are subject to routine risk‐bearing capacity assessment. A Monte Carlo simulation function inte‐ grated into the risk reporting system is used for this purpose. This helps to assess risks and risk portfolios by determining, for given probabilities (confidence levels) in a random experiment with 100,000 runs, whether risks will materialise and what damage could be expected. Potential interactions and dependencies between the individual risks are also taken into consideration. Variousrisk measures, such as expected values,standard deviations, Value@Risk, and Conditional Value@Risk in conjunction with predefined confidence levels enable a comprehensive view of the risk portfolio.
Environmental and industry risks
Economic risks
Biotest would be unable to avoid on a sustained basis the consequences of a far‐reaching, long‐lasting, global recession, even if its direct effects were limited. The risk of a downturn in sales revenue could arise from greater pressure from customers to reduce prices. A further potentially dampening effect is the possibility that Biotest will be forced to reduce or discontinue supplies to individual markets. This could be the case if the company were unable to adequately hedge against default on corresponding receivables or were able to do so only at much lessfavourable terms. If a country's overall economic position were to deteriorate to such an extent that concerns would arise about serious consequences for its solvency and healthcare system, Biotest could be forced to discontinue deliveries to such coun‐ triesin order to reduce itsrisk. The armed conflicts and continuing or even increasing political instability in important marketsfor Biotest in the Near and Middle East may lead to deterioration in the economic and business situation in these regions. Persistently high inflation could have a negative effect on expenses (especially for raw materials, energy, and logistics). Unchanged from the previous year, the Board of Management assesses this risk as having a moderate probability of occurrence and a moderate negative effect on the financial position and performance. For this reason, Biotest classifies economic factors as a moderate risk.
Sales market risks
Sales market risks consist of risks associated with price, quantity, substitution, and payment default. The Biotest Group is reducing the risk ofshort‐term fluctuations in sales volumes and prices by expanding into additional international markets and by establishing longer‐ term supply agreements. Nevertheless, the risk remains that the volume of sales could be lower than planned, especially in the case of some tendered business.
A risk exists of reductions in market prices for plasma proteins.
Unpredictable political, economic and regulatory changes in some of the company's main markets could exert a significant effect on sales volumes. For Biotest, this currently applies especially to markets in the Near and Middle East.
Biotest identifies rising risks from increasing cost pressure in highly developed markets' healthcare sectors due to general recessionary trends. This is because countries are increasingly adopting corrective measures to reduce the cost of medicines. Manufacturer rebates and price moratoriums in Germany and Austria, as well as mandatory rebates in other European countries such as Italy and Romania, often set examples for other countries such as France as well as the UK. However, temporary relaxations of these coercive measures for intravenous immunoglobulins (IVIG) due to limited product supply and tight supplies of merchandise have recently been questioned, or reversed, in some countries. As a further corrective measure, governments are endeavouring to reduce prices in their own countries by making references to countries with lower prices (so‐called price baskets).
Especially in the area of haemophilia A therapy, and thereby also for plasmatic coagulation factors, healthcare systems are exerting increasing price pressure,so that Biotest is only able to sell its coagulation factor products at economically viable pricesin a few markets. Overall, the Board of Management of Biotest AG classifies the associated risks as high.
According to the observations of the Biotest Group, demand for plasmatic coagulation factorsis diminishing compared with recombinant factors, as well asforso‐called non‐factor preparations(such as emicizumab [Hemlibra®] and Elocta®). In some cases, these can be utilised at longer intervals and thereby more conveniently. For this reason, it is expected that the use of non‐factor preparations will continue to expand over the coming years and that plasmatic coagulation factors will lose market share.
Further sales risks arise in the area of hyperimmunoglobulins, and especially for the CMV hyperimmunoglobulin Cytotect®, given new antiviral therapies such as Letermovir and Maribavir. These therapies are already competing with Cytotect® in important markets and pose a risk to Cytotect® sales in the future.
A general risk also existsthat Biotest products based on immunoglobulins and hyperimmunoglobulins will be replaced in the longer term by alternative therapies such as immunoglobulin receptor agonists, or gene therapeutics. The Board of Management considers these substitution risks, unchanged from the previous year to be moderate.
In competing with other larger plasma manufacturers, the low number of products from a litre of plasma and the Biotest Group's other cost structures could result in disadvantages in terms of the margins achievable on sales markets. The Board of Management regards this risk as moderate.
Default risk continues to be high due to the lower credit standing of companies and governments in some regions. Biotest has set up an active receivables management system and takes the necessary measures to minimise risks, such as a stop on deliveries. Furthermore, credit insurance exists for many countries and customers. Unchanged from the previous year, the Board of Management considers the default risk relating to receivables from customers in countries subject to sanctions by the European Union, especially in the Near and Middle East, to be a high risk.
Legislative policy changes can also pose a sales market risk: in many European countries, maximum limits have been set for the use of pharmaceuticals. Pharmaceutical companies are thereby required to reimburse the health authority up to 100 % of the amount sold above the specified ceiling. Non‐European countries also have similar laws or are planning restrictions on drug prices. The Board of Management regards this risk, unchanged from the previous year as moderate.
Entry into a market is associated with high costs for distribution authorisations of products as well as infrastructure costs, such as the founding of a subsidiary. If countries modify their regulatory frameworks and bureaucratic procedures, unexpected delays could occur to market entries. In this case, Biotest endeavoursto assesssuch risks and minimise them where necessary by making recourse to experts in the respective market. The Board of Management regards this risk, unchanged from the previous year as moderate as well.
Further risks for Biotest products, which are produced exclusively in Germany and Europe, could arise, for example, from customs duties on medicinal products from the EU in general and on medicinal products produced using US plasma.
Plasma procurement risks
Biotest requires special raw materials and excipients in order to manufacture its biological medicines. If these materials were to become scarcer or increase substantially in price, Biotest's ability to manufacture or to supply could be restricted. Biotest procures many of the raw materials it needs, especially plasma, from its own sources, which are being gradually expanded.
In recent years, the market for plasma hasincreasingly consolidated, with the consequence that only a few free plasma collection centres remain that are not already owned by plasma manufacturers. In addition, regulatory requirements were tightened in various procure‐ ment markets. This increases the risk and could lead to further sharp rises in plasma prices. The establishment of our own plasma col‐ lection centres and the conclusion of long‐term agreements represent further measures to minimise procurement risks.
Were a shortage in the plasma supply market as well as further price increases to arise, a risk exists that Biotest would only be able to procure sufficient volumes of plasma, particularly from the USA, on terms that are no longer economically viable. This could lead to underutilisation of both the old production plant and the Biotest Next Level plant and thereby to vacancy costs.
As only products made from US plasma may be sold on the US market, US plasma is mandatory for this purpose. Due to a potential shortage of US plasma, it may not be possible to fully realise planned sales revenues of Biotest end products in the US market after approval of the products.
Biotest endeavours to secure the plasma volumes it requires through long‐term supply agreements, and also enters into long‐term partnerships in order to secure access to plasma, especially in the USA (see B.III.1. Partnerships). Furthermore, the possibility exists that Biotest will again purchase plasma from Grifols plasma centres in the USA, as in the past.
Due to the generally long‐standing business relationship and the intensive dialogue that Biotest maintains with plasma suppliers, the Board of Management considers the probability of occurrence of these risks to be low. Owing to the potential level of damage from individual risks, the Board of Management, unchanged from the previous year, classifies the fundamental risks from plasma supplier relationships as moderate risks and, with regard to plasma procurement, as high risks.
Political risks
Biotest generates some of its sales revenue via tender business. In certain countries, such business could be subject to a high level of political influence, which could in certain cases be to Biotest's disadvantage. As Biotest has a high level of risk awareness concerning tender business in these countries, the associated risks are considered minor. Biotest maintains relationships with companies all over the world. In unfavourable circumstances, a destabilisation of the political situation in some countries could negatively impact business relationships and business prospects. These could include currency export restrictions, or import and export bans, which could jeopard‐ ise business relationships between Biotest and typically government‐run institutions in such countries.
In addition, it is becoming apparent that the US administration under President Trump is abandoning the universal advantages of stable regulatory systems (e.g. largely free trade within the framework of the WTO or NAFTA) and instead is unilaterally seeking short‐term negotiating successes that are advantageous for the US. Concrete deteriorations for Biotest could result from tariffs on drugs from the EU in general and on drugs produced with US plasma in particular, as well as from a higher plasma price due to border closures with Mexico and lower plasma donations.
Given the war that broke out in the Middle East in October 2023, the situation in this region failed to stabilise in the 2024 financial year. As Biotest is represented in these countries, it is thereby exposed to greater risk. A further risk is that it remains difficult to obtain payments for pharmaceutical supplies exempted from embargo and sanction measures from countries otherwise subject to sanctions. Biotest endeavours to minimise such difficulties through intensive contact with its banks and by explaining the underlying transactions. Biotest continuously monitors all political risks. The potential economic consequences of a materialisation of such risks are analysed closely in order to implement appropriate measures.
In 2024, the US administration continued to fail in its attempts to reach an agreement with Iran on a resumption of the nuclear deal, so that tighter US sanctions continue to apply unchanged. The military conflict with Israel has significantly exacerbated the foreign policy risks once again. Both developments could have a negative impact on the Biotest business in Iran. They could also lead to the complete termination of business relationships, and resultant impairment losses. The Board of Management does not rule out the possibility that the situation may deteriorate in the short term as a consequence of the domestic political situation in Iran or US sanctions.
In June 2018, a constitutional amendment came into force in Turkey. This amendmentsignificantly expanded the power of the President and abolished the office of the Prime Minister. The economic and financial situation remains unsettled and is characterised by a volatile Turkish lira. This could lead to income losses in a low single‐digit million‐euro amount for Biotest over the next ten years.
Russia's attack on Ukraine is exacerbating the geopolitical risk situation. For this reason, a risk exists that sales revenues in Eastern Europe will not materialise, supply chains will be interrupted, and construction materials, spare parts, and auxiliary materials will only be delivered with considerable delays or at significantly higher purchase prices.
Overall, the Board of Management classifies the political risks as high risks, as in the previous year.
Corporate strategy risks
Risks associated with Biotest Next Level
Biotest began developing three new product lines, the associated manufacturing processes, and the construction of new production capacities in 2013.
As part of the Biotest Next Level project, the production process is being transferred from the current production facility, from the pilot production plant (Clinical Manufacturing Plant, CMP) to a larger scale for later commercial production (scale up). Comparability must be demonstrated for the new process to ensure that the pharmaceutical product manufactured on a commercial scale is "identical" to that of the clinical trial phase and that the same therapeutic effect will be achieved. During the transfer and scale‐up of the process from development,significant differences could arise in the processing and/or in the product manufactured on a large scale. This would entail a process adaptation ofthe new process and would be associated with additional costsfor process adaptation as well as delaysin product approval.
The possibility also exists of delays due to the need for coordination between individual production units. Furthermore, a need exists for capacity adjustments in areas that support and supply production.
For the production of the first product, Yimmugo®, from the new production facility, distribution authorisation for Germany was granted in November 2022. Marketing authorisation for Yimmugo® in the USA was applied for in June 2023. Yimmugo® received approval from the Food and Drug Administration (FDA) in June 2024. Biotest immediately started to ramp up production. The launch on the US market is planned for the first half of 2025. The strategic partner for sales in the USA is Kedrion Biopharma, Inc., Fort Lee (NJ), USA, a global biopharmaceutical company.
The application for marketing authorisation for the second product from the new production facility, Fibrinogen, was submitted in par‐ allel to the regulators in Germany, Austria, and Spain at the end of October 2024. The submission to the FDA in the USA took place in December 2024. In this regard, preparations are underway for the inspection by the US authorities that will then be due. To reduce the risk relating to the FDA inspection, a separate project was established to ensure that the entire production in connection with Fibrinogen complies with FDA requirements.
The validation of the facilities for the production of Trimodulin and albumin is still pending. All inspections carried out to date by the Hesse State Office for Health and Care, Darmstadt, Germany (formerly the Darmstadt Regional Council) and the Paul Ehrlich Institute in Langen have been successfully completed; subsequent inspections by German and foreign regulators are still pending.
The milestones still to be reached for the validation of the plants cannot be achieved, especially but not exclusively for Trimodulin and albumin, if the predefined process and production specifications are not met.
If serious problems or delays were to occur, such as due to the war in Ukraine and in the Middle East, post‐pandemic‐related supply bottlenecks at external contractual partners, or due to staff shortages, the possibility of a value adjustment of the Biotest Next Level plant cannot be ruled out. As it is a long‐term project, the Board of Management assesses short‐term risks associated with Biotest Next level as moderate, as in the previous year.
Research and development risks
New medicines undergo several pre‐clinical trials and clinical trials prior to marketing authorisation and market launch. The risk exists that a previously assumed therapeutic effect may not be confirmed or that unexpected medical risks will negatively impact the bene‐ fit/risk relationship. As development programmes may have to adapt to new findings in terms of their development or further develop‐ ment, the associated costs and development times cannot always be forecast accurately – unexpected additional costs and longer de‐ velopment times could arise. The post‐pandemic situation, in particular, and the strained situation in clinical trials centres have made delays in clinical development more likely. Changes in the market environment, in particular competitive developments, as well as other external factors such as requirements for approval, and the regulatory environment or the subsequent reimbursement of new drugs, can also have a negative impact on development, timelines, and strategy. For example, constantly increasing requirements to provide evidence of the additional benefits of new products compared to current products, or to demonstrate economic health benefits, are playing an increasingly important role in drug development. These benefits must be proven as early as possible during the product developmentstage, otherwise a high risk existsthat the company will be unable to obtain a sufficiently high price on the market to cover its development costs. Given constantly evolving regulatory requirements, a possibility exists that indications for older products will be restricted.
Yimmugo® received marketing authorisation in Germany in mid‐November 2022. Marketing authorisation has been granted in further European countries, as well as for the USA, as of the end of June 2024. Concurrent with its authorisation of Yimmugo®, the FDA certified the site in Dreieich, Germany.
The high complexity associated with the construction, qualification, and commissioning of the new plant requires particularly close con‐ trol and monitoring of product development and approval as well as production planning. In addition, unexpected events in one of the programme strands could lead to the Biotest Next Level manufacturing plant reaching profitable utilisation later, or not as planned, and to the part of the carrying amount of this plant having to be written down. The Board of Management considers this to be a moderate risk. In the very unlikely event that the aforementioned development projects fail, few other projects are being pursued or planned where distribution challenges may also arise. As research and development projects are very long‐term projects, the Board of Manage‐ ment gauges the short‐term risks of current projects as low, as in the previous year.
In 2024, Biotest successfully completed the phase III trial for the use of Fibrinogen in the indication of acquired fibrinogen deficiency and the commissioning of the production facility for market supply. The first applications for marketing authorisation have been submitted in important markets in Europe, and are planned in the USA. Acceptance of the clinical trials by the European and US authorities is a prerequisite for marketing authorisation. A risk for the USA remains, as the clinical trials 984 and 995 were not coordinated with the US authorities in advance and no patients from the USA were included. It is also possible that regulators in Europe and the USA may ask further questions about pharmaceutical or clinical development, which could delay the authorisation process.
The ESsCAPE study is being conducted in patients with severe community‐acquired pneumonia (sCAP) who require invasive mechanical ventilation. The ESsCAPE study is conducted in several countries around the world, amongst others in the USA. The participation of countriesin both the northern and southern hemispheresis particularly important in studiesin community‐acquired pneumonia in order to reflect the seasonal effects of infectious diseases and thereby mitigate variation in the inclusion of patients.
The progress of development projects is monitored constantly through milestone planning. The new data obtained from the entire development strands are evaluated in interim analyses. This creates a reliable basis for decisions on the further course of the project. Development risks are systematically recorded, monitored, and managed as part of long‐term risk management.
Performance‐related risks
Process and production risks
Process and production risks can arise if efficient and environmentally compatible service provision were to be impaired by inefficient structures and production processes as well as by natural hazards. Personnel risks in production arise from potential deliberate or acci‐ dental misconduct by employees that could negatively affect production efficiency orsafety. The Board of Management regards this risk as moderate.
Biotest constantly monitors and analyses its production processes in order to take early action against any risks. All employees involved in production become familiar with production workflows by reviewing our operating procedures. Potential risks are countered by adopting extensive and precisely documented standards and operating procedures as well asregularstaff training. A further risk is posed by changes in regulatory requirements whose implementation necessitates technical developments.
The risk of production‐relevantsystem failure due to the advancing age ofsome systemsis minimised especially through regular mainte‐ nance, operational checks, experts, and service agreements with manufacturers. Systematic works structure planning also ensures the renewal and maintenance of all systems. The Board of Management regards this risk as moderate, as in the previous year.
Supplier relationship risk
A risk exists that individual business or cooperation partners may fail to meet their obligations properly, or that they terminate existing agreements. In some areas, suppliers have processes and products that are not easily substitutable, so that their failure could lead to higher expenses or even production delays.
In 2024, some global shortages arose of raw materials and preliminary products. Production bottlenecks at suppliers could also arise due to disruptions to international supply chains. Furthermore, many upstream suppliers are facing significantly higher demand, which
could lead to capacity bottlenecks. Biotest takes such risks into consideration by continuously monitoring the supply situation and pro‐ actively initiating suitable measures at an early stage if necessary. This also includes flexible adaptation of stockpiling in some areas, close dialogue with suppliers, and the evaluation of alternative sources of supply.
In addition, the Biotest Group is exposed to the risk of being held liable for possible breaches of duty by its partners. Furthermore, long‐ term supply agreements with guaranteed purchase volumes are also associated with the risk of being unable to purchase these volumes in time, or of the supplier demanding compensation or terminating the agreement in case of non‐compliance with the delivery quantity. Given that business relationships generally last many years and in view of the close dialogue maintained with suppliers, the Board of Management is of the opinion that the probability that these risks will materialise islow. Due to the potential amount of loss of individual risks, the Board of Management considers the risks arising from supplier relationships to be high, unchanged from the previous year.
Risks relating to plasma as a raw material
As in the previous year, there is a very low risk that plasma contaminated with currently known but undetected or previously unknown pathogens (bacteria, viruses or prions) could enter the production process. This could lead to contamination of end products. Potential consequences could be that the products cannot be distributed or, if the problem only becomes known after distribution, that individual batches have to be recalled from the market (by the authorities, or at Biotest's own responsibility in the person of the person responsible for the step‐by‐step plan). In the worst case, marketing authorisation could be restricted or even cancelled. In addition, contamination caused by currently unknown bacteria, viruses, or prions could result in tighter legislative controls on plasma‐based medicines. In the event of reports from the market of suspected contaminated end products, these are recorded and analysed as part of the pharma‐ covigilance system. In the unlikely event of a confirmed contamination, this would lead to risk‐minimising measures, such as a recall of the affected batch(es), and measures in production to prevent or minimise a recurrence of the problem. This is still considered a low risk. Donors are tested for donor suitability, and if an infection or other health abnormality is detected that was not known at the time of donation, a lookback process is initiated. All plasma donations from the affected donor are identified and traced. This includes all donations made within a certain period preceding the diagnosis. As the plasma is stored for 60 days before being used in production, the affected donations can still be extracted and destroyed. The test procedures employed by Biotest are in line with the latest scientific standards. Production takes place exclusively in appropriately qualified clean rooms, and the manufacturing process includes various steps to inactivate or remove viruses and prions. For this reason, the contamination of end products is highly unlikely.
Compliance and legal
In its business activities, Biotest encounters risks arising from both civil and public law. The Compliance Department analyses how the business units concerned identify and track legal risks and address them through preventive and remedial measures. This analysis fo‐ cuses on general legal risks that are not specifically linked to the sector, such as corruption and antitrust violations, while the drug authorisation, drug safety, and quality management departments, among others, independently monitor and addresslegal risksthat are specific to the pharmaceutical industry.
The risk exists of corruption in competing for supply contracts and in procurement. Employees could influence the awarding of contracts by granting or accepting undue advantages. In order to counteract this risk, the Biotest Group further strengthened its compliance measures again in the 2024 financial year. The Corporate Compliance Officer is in close communication with the Board of Management for this purpose.
The compliance processes were also further developed in 2024, primarily through the coordination of compliance standards with the Grifols Group, the intensification of due diligence of business partners and their beneficial owners in high‐risk countries, work on the implementation of an electronic whistleblower system, and the further expansion of existing training and testing systems.
Transactions with healthcare professionals (in other words, doctors, pharmacists, and registered nurses) that may involve compliance risks are subject to the prior written approval of the Compliance Department. Furthermore, the Compliance Department reviews sup‐ porting documentation for invoices from this area. This processis also used for the annual publication of the so‐called transparency data (listing of donations provided to healthcare professionals, for example), which Biotest AG has committed to disclosing as a member of AKG e.V. (an association dedicated to medicines and cooperation in healthcare).
In addition, the Legal and Compliance departments actively address antitrust risks that are typical for a manufacturer of medicinal prod‐ ucts from blood plasma. In 2024, the Biotest Group Compliance Officers continued to hold conference calls in order to exchange infor‐ mation about activities and working results in their respective countries.
Based on their risk exposure, employees in all departments of the Biotest Group regularly receive training on the risks affecting them and current developments in the compliance area. Employees with contacts to specialists must pass an annual electronic test. All em‐ ployees receive basic training every year on the Code of Ethics and Conduct of Biotest AG. This also requires that all staff pass related tests. In addition, every employee must confirm that they are aware of and comply with the rules of the Code. All distributors and agents are informed of any changes in the Code of Conduct. They confirm every year that they have received and taken note of the Code of Conduct.
The managers of Group companies may only engage in business transactions with a material effect on the Group's financial position and performance or the Group's risk position with the prior approval of the Group's management.
The compliance management system is reviewed regularly for its appropriateness and effectiveness by the Internal Audit department. The last audit was conducted in the fourth quarter of 2024.
In 2021, the Romanian Competition Council intensified antitrust investigations against the Plasma Protein Therapeutics Association (PPTA), a non‐profit association representing the interests of plasma derivatives manufacturers, Biotest, and some of Biotest's competitors. The proceedings are based on the allegation of a coordinated strategy by the companies mentioned to limit or stop the supply of immunoglobulins to Romania. Most recently, the authority issued a fine notice against Biotest, against which Biotest is taking legal action. Biotest considers the allegations to be unfounded. For this reason, Biotest continues to consider the risk of a financial penalty from these antitrust proceedings to be low.
Due to Biotest's activities in many countries with above‐average risks of corruption and other white‐collar crime, compliance and legal risks are classified as high risks, after still being categorised as medium risks in the previous year.
Personnel risks
Further risksinclude the possibility that Biotest will not be in a position to retain employeesin key positions or to find suitable candidates for such positions. Biotest addresses this risk through continuous and targeted employee training, special onboarding measures, and attractive entry and training programmes. The performance‐based remuneration of specialists and managers and measures to retain employees also reduce personnel risks.
Employees' personal commitment in conjunction with the increased workload in the numerous development and expansion projects harbours the risk of working time violations, which are countered in cooperation with the works council.
The Board of Management considers the personnel risks again to be moderate this year.
IT risks
Many production and other business processes at Biotest rely on IT support. The Group has been utilising an integrated standard busi‐ ness software package, the SAP ERP Business Suite,since 2008. Business data security and business continuity rank as top priorities. This applies both to the stability of the IT systems and backup solutions as well as to protection against unauthorised third‐party access and potential attacks from the Internet. Biotest is continuously increasing its already comprehensive use of IT systems and at the same time enhancing the respective security systems. System functionality is constantly being improved in the areas of production, quality control, and quality assurance in order to reduce risks and ensure product quality. Key systems (such as SAP and central file services) are also designed redundantly. The proper handling of systems and data is governed by working instructions and is ensured through appropriate training. Raising employees' awareness of constantly new types of cyber criminality is also becoming increasingly important. Due to the complexity of the systems and the threat situation, unexpected problems that have a negative impact on ongoing business can never‐ theless arise. As in the previous year, the Board of Management gauges information technology risks as moderate risks.
Financial and currency risks
Interest rate risks exist for the variable interest liabilities, as the interest cost can change due to changes in the agreed market interest rate. Changes in interest rates could exert both positive and negative effect on earnings. The current probability of further interest‐rate increases, and thereby a further negative earnings effects, is regarded as manageable. As far as investments in listed companies are concerned, changes in stock market prices can have both a positive and a negative impact on earnings. At present, interest rate risks are not hedged, although market interest rate changes are continuously monitored in order to be able to take countermeasuresif necessary. As in the previous year, the Board of Management considers the interest rate risk to be moderate.
As an international company, Biotest AG conducts business in various currencies. Changes in exchange rates create opportunities and risks for the business results of Biotest AG. The risks are determined centrally and appropriate measures are derived to control them. Currency risks are hedged, as far as reasonable and possible, by deploying derivative financial instruments such as forward exchange contracts. As a general rule, already executed underlying transactions are hedged. Sales in US dollars continue to be offset by purchases in the same currency (natural hedging). However, despite these measures, a massive devaluation of individual currencies could affect the consolidated results. For this reason, potential currency risks are monitored continuously, and appropriate hedges are entered into where necessary. The Board of Management considers the currency risks to be moderate risks, as in the previous year.
Financing risk
A large part of the financing is secured by a subordinated shareholder loan in the nominal amount of € 290 million, which was extended on 15 March 2024 until 2 January 2030. On 24 June 2019, Biotestsigned an agreement with a term of five yearsfor a loan of € 240 million, which fell due in the 2024 financial year and was repaid in full. In addition, a further external loan of € 44 million and one of € 0.1 million exist and, since 2023, a financing agreement with Grifols Worldwide Operations Limited totalling € 147 million, which was fully drawn down in 2024. Furthermore, additional short‐term financing from Grifols Worldwide Operations Limited in the amount of € 50.3 million was utilised. Biotest AG is dependent on the fact that financial liabilities that fall due can be refinanced, if necessary, and that existing financing commitments are adhered to. If reliable and timely financing cannot be guaranteed, solvency could be jeopardised. Biotest AG is sustainably financed with two key financing components – a subordinated shareholder loan totalling €290.0 million and two financing arrangementsfrom Grifols Worldwide Operations Limited for € 197.0 million. In addition, a letter of comfort was agreed between Biotest AG and Grifols, S.A. on 20 December 2024 to secure the liquidity requirements of Biotest AG, limited in time until 31 December 2026. Biotest AG thus has a stable financing basis until the end of 2026. Additional ongoing effortsin working capital management are strength‐ ening the company'sinternal financing capability. Moreover, at the end of December 2024, the Biotest Group had cash in hand and bank balances of € € 107.8 million, from which the current business and upcoming capital expenditure are financed. Of this amount, € 11.4 million serves as collateral for guarantee facilities granted. In 2024, Biotest entered into a factoring agreement between the Gri‐ fols Group and a Spanish factor and can now sell a volume in the lower double‐digit‐million‐euro range. The risk is assessed by the Board of Management as having a low probability of occurrence and a high negative impact on the earnings, net assets and financial position; accordingly, Biotest classifies the financing risk as moderate risk, while it was still considered low in the previous year.
Other risks
Risks due to side effects or interactions of the pharmaceutical products
Unexpectedly severe, more frequent, or to date unknown side effects or interactions with other medicines can arise when taking drugs. Inappropriate handling, storage, or use of our products could also give rise to significant adverse effects for customers and patients. As part of the pharmacovigilance system (PVS), reported suspected cases of side effects or interactions are recorded, investigated, and analysed by Biotest, and further risk‐based measures to minimise risks are taken. Pharmacovigilance and drug safety are important topics in this context. Core elements of the pharmacovigilance system encompass the expertise of employees with qualifications in medicine, pharmaceuticals, or other natural sciences as well as validated structures for data processing, data analysis, and reporting to regulators. The system also requires each international subsidiary of Biotest to employ a local contact for pharmacovigilance and each cooperating partner to designate one. The Corporate Drug Safety department is responsible for the establishment and continuous up‐ dating of the pharmacovigilance system. The measures to be adopted in agreement with regulatory authorities can range from contin‐ uation of the established pharmacovigilance routine described in Standard Operating Procedures (SOPs), additional data analysis, ex‐ change of information, supplements to the information in the package information leaflet in the sections side effects, warnings, and contraindications all the way through to restriction or withdrawal of the marketing authorisation. The latter would have considerable negative effects. Thanks to established and independently audited pharmacovigilance processes and extensive experience with the product portfolio, Biotest is unlikely to experience serious consequences resulting from unexpected side effects. Overall, the Board of Management considers the risks in this area to be low, as in the previous year.
Risks caused by quality defects
Biotest meets the most stringent national and international criteria of Good Manufacturing Practice (GMP) and ensures, largely through its Manufacturing, Quality Assurance (QA) and Quality Control (QC) departments, that defects remain very rare exceptions. In conjunc‐ tion with the pharmacovigilance system, the most rapid possible detection of suspected safety‐relevant quality defects, their analysis, assessment in terms of medical risks and, if necessary, correction and risk minimisation are guaranteed. Additionally, a competent, objective, and well‐founded decision is ensured. Quality defects could be suspected as a result of internal quality control conducted as part of manufacturing and/or checks ("deviation reports") as well as due to customer complaints from the market ("product technical complaints") and are recorded similar to reports of side effect by the Corporate Drug Safety department. If a risky quality defect were to be confirmed, risk‐minimising measures would be evaluated and implemented independently and immediately, in coordination with regulators, through the Biotest Medical Alarm Plan Committee (MAPCOM) as part of the respective process and directed by Corporate Drug Safety. A typical immediate measure, as a result of risky defects, would be an immediate blocking of stock goods and potential recall of delivered goods so that their further administration is prevented. Preventive recalls of potentially defective batches are very rare for individual products but are known and accepted by pharmacists and prescribers as a reliable routine process for targeted risk minimisation in the pharmaceutical industry as a whole. Only in the extremely unlikely event, such as repeated occurrence, can quality defects lead to the withdrawal of approval. Nevertheless, the costs of a recall limited to certain batches can also represent a significant burden.
With an overall low probability of occurrence, the management assumes a moderate risk, as in the previous year.
Risks caused by defects in the pharmacovigilance system (PVS)
The pharmacovigilance system under the responsibility of the marketing authorisation holder ensures that national and international requirements (Good Vigilance Practice, GVP) for monitoring product use and drug safety are met as a prerequisite for granting and maintaining marketing authorisations for drugs. The Corporate Drug Safety department is responsible for its implementation in the company.
Defects in the pharmacovigilance system, especially the improper handling of suspected cases of side effects, interactions, or claimed quality defects, could not only damage Biotest's reputation with the supervisory and regulatory authorities but also be subject to a fine for the territory of the EU for the marketing authorisation holder (up to a maximum of 5 % of the annual sales revenue in the EU per defect). Furthermore, they could result in the withdrawal of the drug marketing authorisation in severe, repeated cases. Biotest ensures a very high level of reliability in this area by continuously developing transparent processes and through cross‐departmental, interna‐ tional training courses for staff who deal with these topics. This was consistently confirmed in routine inspections by international au‐ thorities, most recently in September 2018 by the Paul Ehrlich Institute in the context of the German Medicinal Products Act (AMG) and Good Vigilance Practice (GVP), and in July 2023 by the Hesse State Office for Health and Care in Darmstadt in the context of the German Pharmaceuticals and Active Ingredients Manufacturing Ordinance (AMWHV). Moreover, intensive dialogue with clinics, doctors in pri‐ vate practice, and pharmacists ensures that we are informed promptly about potential newly identified side effects and interactions. For this reason, the Board of Management considers the risks in this area to be low, as in the previous year.
Risks arising from ongoing litigation and tax risks
All identifiable risks from employment law and other ongoing litigation are covered through provisions. Furthermore, tax risks could arise from previous years' tax audits. This would be the case if the fiscal authorities were to assess tax items in a different manner to the accounting policies applied by Biotest Group companies. As in the previous year, the Board of Management considers the risks in this area to be low.
Biotest recognises deferred tax assets to the extent that it is probable that taxable profit will be available against which the deferred tax assets can be utilised. Weaker than expected taxable income may have a negative effect on the recoverability of deferred tax assets. The Board of Management still considers this to represent a low risk.
Risks from the divestiture of companies or parts of companies
The divestiture of companies or parts of companies could lead to liability to the buyer, for example due to indemnity or guarantee commitments. As in the previous year, the Board of Management identifies a low risk here.
Risks associated with pandemics/epidemics
Biotest is an internationally operating Group. In this context, the unfolding of more dangerous variants of coronavirus or the spread of a new virus could have a negative impact, in particular on conducting businessin regions affected by a pandemic/epidemic. Furthermore, the spreading of such viruses could lead to the closure of plasma centres or negatively impact the population's willingness to donate plasma, as well as employee health and availability for work.
Postponed surgeries and transplants, as well as the reduced number of hospital outpatients, could lead to reduced demand for immu‐ noglobulins and hyperimmunoglobulins.
Appeals or government orders to restrict contact as well as social distancing measures could reduce opportunities for plasma donation and lead to a reduction in the capacity of plasma collection centres. This could lead to a significant decrease in the supply of the raw material blood plasma and reduced availability of end products.
To contain a pandemic or epidemic, countries could make access across their borders more difficult, potentially resulting in a delay in delivery due to unavailable transportation.
It is possible that plasma exports for further processing in countries such as Germany could be banned or made more difficult. This applies in particular to the largest plasma exporter, the USA.
These effects of a pandemic or epidemic could have a negative impact on the company's financial position and performance. As in the previous year, the Board of Management assesses this risk as low.
D.II.7 GENERAL STATEMENT ON THE GROUP'S RISK POSITION
Russia's attack on Ukraine and the conflicts in the Middle East have exacerbated political risks. The effects of high inflation rates and higher prices for the raw material plasma are also increasing the pressure on the Biotest Group's margins. Above and beyond this, the Board of Management is of the opinion that at present Biotest is not exposed to any significant risks beyond those that are inextricably linked to the existing business, the Biotest Next Level investment project, and development activities. All signif‐icant risks are continu‐ ously monitored. If possible and reasonable, appropriate hedging of possible financial consequencesis undertaken. Over the next twelve months, Biotest AG will continue to utilise financial support from its main shareholder Grifols, S.A., Barcelona, Spain, in order to ensure the acceleration of development activities and the start‐up of the Biotest Next Level facility. Although external and internal conditions have led to certain changes in the assessment of the individual risks described above, the overall risk assessment has not changed significantly in the 2024 financial year, with the exception of the circum‐stances described above. At present, no discernible risks exist that could jeopardise the Biotest Group as a going concern.
D.III. OPPORTUNITIES REPORT
Biotest views risks and opportunities from an integrated management perspective. By continuously monitoring developments in sales markets and regulatory conditions, the company is able to identify opportunities at an early stage. Current opportunities form the sub‐ ject of regular reports to the Board of Management. In the event of a change in opportunities requiring immediate action, the Board of Management is notified directly and at short notice. Biotest thoroughly evaluates any identified opportuni‐ties and makes decisions regarding possible capital expenditure based on the results. Potential risks are also considered in as‐sessing opportunities. Finally, the potential project must be in line with the Group's strategic orientation.
D.III.1 OPPORTUNITIES ARISING FROM DEVELOPMENT OF THE PRODUCT PORTFOLIO
In recent years, Biotest hasinvested heavily in the skills and expertise required for drug development and marketing authorisation. These capabilities will be further utilised to enhance the product portfolio as well as indications, and improve access for patients worldwide. Moreover, new and highly efficient production capacities utilising innovative technologies are being put into operation in order to meet growing demand for its therapies. The deployment of these new technologies and associated efficiency gains will be replicated through‐ out the entire supply network and utilised for future projects. Further economies of scale can be expected if Biotest expands its network of internal plasma collection centres, utilising proven processes, and sharing central resources.
D.III.2 OPPORTUNITIES ARISING FROM THE CORPORATE STRATEGY
In 2024, Biotest AG and Grifols, S.A., further intensified their partnership with the aim of optimising the commercial strategy and opti‐ mally driving the international expansion of the business. Please see our remarks in section A. I. The Group's business model.
Competitive advantages and consequently opportunities could also arise in the future from further strategic research and development as well as distribution cooperation agreements. Numerous opportunities that will take the Biotest Group to a new level derive from productivity enhancement and the doubling of production capacities that are planned as part of the Biotest Next Level project, with a special focus on the marketing authorisation and sale of these new products in the important US market. Although Kedrion will be the future distributor of Yimmugo® in the USA, Grifols intends to provide Biotest with a portion of the required US plasma.
In addition, Biotest has the opportunity to expand the use of hyperimmunoglobulins to further indications, and to generate revenues in additional countries. The selection depends on the requirements of the market and the regional conditions.
A further priority is the consistent focus on customer segments such as transplantation. In partnership with leading experts in the trans‐ plantation area, the use of Cytotect® CP Biotest, Hepatect® CP, Zutectra®, Varitect® CP, and Pentaglobin® form the focus area in this context.
D.III.3 PERFORMANCE‐RELATED OPPORTUNITIES
During the course of recent years, Biotest hasinvested heavily in expanding itsresources and expertise in the areas of drug development and marketing authorisation. In addition, the Group is moving into a new dimension by doubling its production capacities. In the future, it will also continue to reap the benefits of its efficiently managed corporate headquartersin Dreieich, where all of the major business departments are concentrated. The resulting synergies and potentials will continue to be leveraged especially in order to conduct re‐ search and development projects more rapidly and cost‐effectively and to enhance production efficiency.
D.III.4 OPPORTUNITIES ARISING FROM THE PARTNERSHIP WITH GRIFOLS, S.A.
With Grifols as a partner and given the intensification of this partnership in 2023, far‐reaching opportunities exist to realise greater commercial potential for the new products from the Biotest Next Level facility. The availability of the raw material blood plasma as well as the purification capacities are crucial here. Grifols' greater commercial reach as well as faster scalability play a decisive role in this context.
The intensified partnership with Grifols has enhanced the chances of jointly generating higher revenuesfor the new products Yimmugo®, Trimodulin, and Fibrinogen with the higher production capacities and a stronger market presence. Biotest would participate in these through additional product sales and, potentially, licence payments.
In addition, opportunities arise from the possibility of obtaining, via Grifols, US plasma from the group's own plasma collection centres. As the marketing of plasmatic therapeutics in the USA and other markets is only possible on the basis of products manu‐factured from US plasma, the procurement of US plasma forms the basis for access to the lucrative US market.
D.III.5 GENERAL STATEMENT ON THE GROUP'S OPPORTUNITIES SITUATION
Given the intensification of the partnership with Grifols, S.A., the Biotest Group's opportunities situation has continued to report a positive year‐on‐year trend. The agreed partnership with Grifols offers far‐reaching opportunities to jointly generate higher revenue from the new products Trimodulin and Fibrinogen thanksto a higherlevel of production capacities and stronger market presence. Biotest could benefit from these opportunitiesthrough additional productsales and licence payments. Furthermore, Biotestidentifiessignificant opportunities in productivity enhancement and capacity expansion as part of Biotest Next Level as well as in the further development of the product portfolio. Opportunities are also identified in relation to Biotest's plasma collection activities arising from the enhanced partnership with the Grifols Group.
E. GROUP DECLARATION PURSUANT TO SECTIONS 315D / 289F HGB
Biotest AG is a public limited company under German law. In addition to the relevant statutory provisions, the company's Articles of Association form the basis for the management, decision‐making and control mechanisms. The declaration pursuant to Sections 315d / 289f of the German Commercial Code (Handelsgesetzbuch, HGB) in its current version can be downloaded from the company's website (https://www.biotest.com/de/en/investor_relations/corporate_governance_.cfm).
F. CONSOLIDATED NON‐FINANCIAL STATEMENT
F.I. GENERAL INFORMATION
F.I.1 PRELIMINARY REMARK
Biotest AG submitted a non‐financial statement/group statement for the first time in 2018 in the form of a combined separate non‐ financial report. The non‐financial statement/consolidated non‐financial statement (hereinafter referred to as the combined non‐finan‐ cial statement) of previous years followed the guidelines, structure and suggested criteria selection of the German Sustainability Code (Deutscher Nachhaltigkeitskodex, DNK).
Directive (EU) 2022/2464 on sustainability reporting (Corporate Sustainability Reporting Directive, CSRD) entered into force on 5 January 2023 and was to be transposed into the national law of the EU member states by the beginning of July 2024. This requirement will apply to public‐interest entities with over 500 employees, who should be required to include a sustainability report in their management report for the first time for the 2024 financial year. The directive has not yet been incorporated into German law by 31 December 2024. This means that the previous legal requirements for the non‐financial statement/group statement will initially continue to apply for the financial year ending on 31 December 2024.
In anticipation of the implementation of the CSRD into German law by summer 2024, Biotest AG prepared its first report in accordance with the CSRD and the European Sustainability Reporting Standards (ESRS). Biotest AG has decided to continue the introduction of reporting in accordance with the ESRS. For the 2024 financial year, Biotest AG will use the ESRS framework. In many areas, the disclosure requirements have already been reported in accordance with ESRS. A table of the ESRS disclosure requirements and the application status of Biotest AG is attached to the summary of the non‐financial statements. The first‐time application of the ESRS and the inclusion of the summarised non‐financial statement in the summarised management report violates the principle of consistency. Full application of the ESRS as a framework is planned for the financial year 2025. The combined non‐financial statement (hereinafter referred to as the sustainability statement) has been prepared in accordance with the requirements of Sections 289b to 289e, 315b and 315c of the Ger‐ man Commercial Code (HGB) and Article 8 of Regulation (EU) 2020/852 on a combined non‐financial statement. Biotest AG thus fulfils its reporting obligations under the German Commercial Code (HGB) at company and Group level.
For enhancing readability, there is a conscious decision to avoid the use of both masculine and feminine language forms simultaneously. Personal names and pronouns are applied equally to all genders.
The Supervisory Board of Biotest AG has reviewed and approved the sustainability declaration. An external audit with limited assurance was carried out by Deloitte Wirtschaftsprüfungsgesellschaft. References to information outside the combined management report are not part of the sustainability declaration and are not among the information audited by Deloitte.
General Information
Biotest AG is a leading provider of biological therapeutics derived from human plasma. With a value chain that extends from preclinical and clinical development to worldwide distribution, Biotest specialises primarily in the areas of clinical immunology, hematology and intensive care. Biotest is involved in the development and marketing of immunoglobulins, coagulation factors and albumin, all of which are derived from human blood plasma. These are used to treat diseases of the immune and hematopoietic systems. Biotest's headquar‐ ters and production facilities are located in Dreieich. In addition to Biotest AG, the group includes 3 foreign distribution companies and 3 plasma collection companies. Biotest has a strong global presence, with its own distribution companies and local partners in approxi‐ mately 70 countries. The company employs 2,666 people worldwide and achieved a turnover of €726 million in the 2024 financial year.
The impact of our business activities on society is immediate and positive, because Biotest produces life‐saving medications for the seriously and chronically ill. By conducting pioneering research and developing innovative products, we generate new opportunities for these businesses and expand the scope of our own operations. Furthermore, these products are derived from human blood plasma, a natural and renewable raw material. Apart from electricity consumption, the subsequent processing, delivery and marketing of the end products have minimal environmental impact. Our value chain is subject to rigorous regulation by a variety of external and voluntary standards, and it is closely monitored to ensure compliance. The company has also confirmed that there is no evidence of forced or child labour, or any other form of exploitation. The blood plasma is a voluntarily donated raw material from healthy, specially qualified adult donors.
Biotest is committed to its responsibility to manufacture and market life‐saving medicines made from human blood plasma with the higheststandards ofsafety, quality and efficacy, while also offering sustainable benefitsto society, patients, employees and shareholders as we work towards carbon neutrality.
In the following chapters, we present our sustainability ambitions and goals, and report on our developments in the ESG aspects that are material to us and our stakeholders. By publishing our impacts, risks and opportunities, targets, measures and key figures, we make our ambitions measurable and hold ourselves accountable.
Principles of the report
The structure of the sustainability declaration is completely in line with the requirements of the ESRS.
Section 289c (2) of the German Commercial Code distinguishes between environmental concerns, employee concerns, social concerns, respect for human rights, combating corruption and bribery, and other aspects. In the report, the concerns are explained in more detail in the following sections:
Aspect of HGB Chapter Reference to the ESRS topic Business model ESRS 2 General information General information Environmental concerns ESRS E1, E3, E5 f Climate Change Water‐ and marine resources Resource use and circular economy Labour concerns ESRS, S1 Employees in the company Social concerns ESRS S1, S4 Consumers and end users Respect for human rights ESRS S1, S4, G1 Employees in the company Consumers and end users Corporate governance Comating corruption and bribery ESRS G1 Corporate governance
Reconciliation of ESRS Topics/Disclosures to Section 289c (1) and (2) of the German Commercial Code (HGB)
The company has developed concepts and due diligence obligations for all the issues mentioned here.
Materiality analysis
In order to determine the most important ESG aspects for Biotest, we conducted a materiality analysis in accordance with the require‐ ments of the ESRS. The result of the materiality analysis can be found on chapter ESRS 2 general information of this report.
The ESRS concept of materiality extends beyond the scope of materiality as defined in section 289c (3) HGB.: The current legal framework dictates that non‐financial aspects and information are considered material only if they are necessary for understanding the business performance, financial results, and position of the company, as well as the impact of its activities on the aspects specified in § 289c (2) HGB. By contrast, the European Sustainability Reporting Standards (ESRS) already consider topics and information material if either the company's activities have significant impacts on people and the environment or if there are material sustainability‐related risks and opportunities from a financial perspective.
ESRS 2 GENERAL INFORMATION
About the sustainability declaration
Biotest AG presentsits combined group sustainability statement (in the following referred to assustainability statement) forthe financial year 2024. These statement reflects the sustainability strategy of Biotest AG, which aims at a comprehensive transformation and re‐ sponsible action in all areas of the company. The central guidelines for sustainable activities are set out in the company's own Sustaina‐ bility Policy, which defines principles, goals and specific future measures for integrating environmental, social and governance aspects (ESG) into the business strategy.
Reporting framework and transparency
The sustainability statement has been prepared in accordance with the consolidated annual statements and includes all subsidiaries over which Biotest has control. The scope of consolidation isidentical to that of the financialstatements, with the exception of BioDarou, which is accounted for using the at equity method. The sustainability statement coversthe entire value chain, including the procurement of raw materials, production, logistics and the use and disposal of products. No material information on intellectual property, know‐ how, innovation results or future developments has been omitted if relevant to the report.
Value chain data includes estimates for Scope 3 emissions, energy consumption, waste data and material use. As complete primary data is not available in all areas, estimates and secondary data have been used for the calculation. (Further information on the calculation basis is disclosed in chapter E1 climate change). Uncertainties in the data situation arise from different collection methods along the value chain, gaps in the Group's own primary data and that of suppliers, as well as modelling assumptions and projections based on industry benchmarks. Primary data: measurements that are taken directly (e.g. how much energy is used at the company's own produc‐ tion sites).
Uncertainties regarding the results: Due to the use of secondary data and model‐based extrapolations, there is a high degree of inaccu‐ racy for the estimated uncertainty margin for the reported key figures. Scope 3 emissions, for which data on upstream emissionsis based on supplier information and average values. Further measures to improve data quality are planned for the coming financial years in order to continuously improve the data quality and accuracy of sustainability reporting and to reduce the scope for uncertainty in the coming reporting years.
The inclusion of information by referring to other parts of the combined report will not be used in the first reporting year, even though this does not exclude the possibility of duplicate reporting. For the first reporting year, the phase‐in option of the ESRS is used. The phase‐in rule constitutes a transitional provision that enables companies to disclose certain information over a period of 1‐3 years.
The reporting period covers the 2024 financial year (from 1 January to 31 December). This sustainability declaration is subject to an external audit with limited assurance to ensure compliance with legal requirements and transparency of reporting.
Intellectual property, innovation results and upcoming developments
Full disclosure of all relevant information, including intellectual property, know‐how, innovation results and upcoming developments. The product portfolio of the Biotest Group is divided into the therapeutic areas of Clinical Immunology, Hematology, and Intensive Care Medicine. It consists of both market‐approved products and those in various stages of product development. Currently marketed prod‐ ucts and new developments are derived from human blood plasma as well as produced using biotechnological processes. The primary therapeutic areas of application include Clinical Immunology, Hematology, and Intensive Care Medicine. The Biotest Group is involved in research and development work in all three therapeutic areas. The company covers the main stages of the value chain, such as pre‐ clinical and clinical development of the preparations, plasma collection, production, marketing and distribution. Biotest AG anticipates the following significant developments for 2025: In 2025, the production facilities in Dreieich will be inspected by the US Food and Drug Administration (FDA) for the approval of Fibrinogen in the USA, which is expected by the end of 2025. The approval for Fibrinogen in the European markets of Germany, Austria and Spain is expected in summer 2025.
Industry‐Specific Sustainability Measures
In accordance with the requirements of the ESRS, Biotest AG has integrated sustainability aspects along its entire value chain. This includes the safety and health of patients, measures to improve energy efficiency in production, sustainable procurement guidelines for raw materials and strategies to reduce the CO2 footprint.
In order to ensure ethical business practices, Biotest AG is subject to strict regulatory requirements and ethical standards in research and development, particularly in the area of clinical studies. These include transparency guidelines for patient education and ensuring compliance with international ethical standards such as Good Practices (GxP) and Good Manufacturing Practices (GMP).
ESG Governance
Biotest AG has established a clear governance structure for the comprehensive management of ESG issues:
| Sustainability working group | ||||||
|---|---|---|---|---|---|---|
Department Corporate Sustainability & Communication
Responsible for the coordination of sustainability strategies.
Develops policies on environmental, social and governance issues in collaboration with the business.
Review Board Sustainability
This group consists of members of the management board and top management.
This group is responsible for decisions on relevant sustainability topics, developments during the year, monitoring and possible adjust‐ ment of ESG targets.
Sustainability working group
A committee of employees has been established to coordinate sustainability initiativesfrom the workforce. The committee isresponsible for addressing sustainability issuesfrom the workforce, taking a bottom‐up approach to ensure their effective resolution and subsequent implementation in the company.
Portfolio Committee Sustainability
Responsible for very large investment projects (A‐projects are highly complex, strategically relevant projects; B‐projects are function‐ specific projects that are reported to the Portfolio Committee in project management) in connection with the company's sustainability goals.
Role of the Board of Management and the Supervisory Board (GOV‐1)
The Board of Management and the Supervisory Board of Biotest AG play a fundamental role in overseeing and advancing the company's sustainability goals, which include:
- Integration of ESG criteria into decision‐making processes: Sustainability aspects are systematically incorporated into business decisions, investment strategies, and risk assessments.
- Regular evaluation and adjustment of the sustainability strategy: The Board of Management review the progress of ESG goals on a quarterly basis and implement corrective measures if necessary.
- Monitoring ESG risks and opportunities: By establishing processes for identifying and assessing material sustainability risks and opportunities, the governing bodies ensure that ESG aspects remain an integral part of the corporate strategy.
- Stakeholder engagement: From 2025, the Corporate Sustainability department will be conducting regular dialogues with rel‐ evant stakeholders on behalf of the Sustainability Review Board, in order to incorporate their requirements and expectations even more effectively into the company's strategic orientation in the future.
Training and Skills Development in ESG
To ensure effective strategic oversight, the ESG expertise of the Board of Management is being continuously expanded. The Supervisory Board has been briefed on sustainability issuesin preparation for Supervisory Board meetings. Further training for the Supervisory Board is planned for 2025. ESG expertise is being developed:
- Collaboration with external ESG experts: Biotest partners with sustainability consultants and specialized organizations to con‐ tinuously enhance the expertise of its leadership bodies.
- Benchmarking and peer reviews: The boards analyze the sustainability strategies of other companies in the industry to opti‐ mize their own measures.
- Internal knowledge platforms and ESG newsletters: The Board of Management and the employees will have access to an internal knowledge platform (intranet) and receive quarterly reports on relevant ESG developments.
These measures are designed to ensure that Biotest's management bodies have the necessary knowledge and tools to actively manage sustainability risks and identify long‐term opportunities.
Parameter
The Supervisory Board of Biotest AG is comprised of 6 members, of which 0 are managing and 6 are non‐managing. The Board of Management of Biotest AG consists of 2 members in total, thereof 2 managing and 0 non‐managing members. Martin Möller resigned from the Board of Management on 16 March 2025. Since 16 March, Biotest AG has only had one member of the Board of Manage‐ ment, Peter Janssen.
The proportion of female members is 0 % on the supervisory board and 0 % on the Board of Management. The proportion of male members is 100 % on the Supervisory Board and 100 % on the Board of Management.
The proportion of independent members is 33 % on the supervisory board and 0 % on the management board. This is based on the definition of independence in the German Corporate Governance Code.
Employee representation
The interests of employees are represented by the close cooperation between the Corporate Sustainability team, the integration of the departments via the various sustainability teams and the sustainability working group. If necessary, the employee representatives are actively involved in the meetings of the Sustainability Review Board. In addition, employee surveys and internal dialog formats are to be conducted in the future to help integrate employee issues even more into the strategic decision‐making of the supervisory bodies.
Composition of the corporate bodies
The composition of the Board of Management and the Supervisory Board is such as to provide a balanced representation of sector‐ specific and geographical expertise. At least 30 % of the members have demonstrable expertise in the pharmaceutical. Furthermore, Biotest AG ensures that experts with international experience are represented in its target markets, in order to take appropriate local regulatory and social requirements into consideration. The members receive regular further training in current ESG and sustainability topics through targeted training programmes.
Roles and responsibilities
- Monitoring of the IROs: The monitoring of the impacts, risks and opportunities (IROs) that have been identified is carried out by members of the Sustainability Review Board. These same members also monitor the implementation of risk‐mitigation measures and regularly assess progress.
- Responsibilities: The responsibilities are defined in the mandates of the Board of Management as well as in the strategic guidelines of Biotest AG. Each sustainability measure is managed through designated responsibilities within the respective specialist departments and coordinated by the Corporate Sustainability department.
-
Integration into corporate management:
- o Monitoring and reporting on the IROs is delegated to the Corporate Sustainability department, which reports di‐ rectly to the Review Board.
- o From 2025, special controls and procedures are to be integrated into the internal audit function. This will ensure a systematic review of sustainability measures.
-
o Sustainability criteria are integrated into the long‐term corporate strategy, and progressisregularly evaluated using defined key performance indicators (KPIs).
- Reporting lines:
- o Corporate Sustainability reports quarterly to the Sustainability Review Board.
- o The results of the review board led by the Board of Management are incorporated into strategic adjustments to the sustainability strategy.
Monitoring the achievement of key IRO objectives
In the future, progress on material IROs will be regularly monitored. To this end, a quantitative and qualitative assessment will be carried out for subsequent reporting periods using defined KPIs. The Sustainability Review Board will then conduct an annual review of the objective and evaluate progress based on the collected dataShould the situation demands it, corrective measures are implemented to ensure ongoing enhancement. The outcomes of this evaluation are integrated into Biotest AG's sustainability reporting.
Availability of specialised knowledge and expertise
The members of the Board of Management and the Supervisory Board have access to expert advice to ensure the strategic monitoring and direction of the IROs. This is done by:
- Internal information on ESG topics, regulatory requirements and sustainable corporate governance.
- Expert advice from ESG professionals and scientists, who provide regular analyses and recommendations on sustainability risks and opportunities.
- Cooperation with external institutions, such as industry associations and sustainability initiatives, to continuously develop the company's ESG strategy.
Biotest AG's measures guarantee that its management bodies possess the essential skills and expertise to proactively manage sustaina‐ bility risks and identify long‐term opportunities in the ESG sector.
Information and sustainability aspects addressed by the Board of Management and the Supervisory Board of the company (GOV‐2)
In 2024, the Board of Management and the Supervisory Board of Biotest AG were informed quarterly about the planned measures to integrate sustainability into internal processes and the results of strategy developments. Reporting is carried out by the Corporate Sus‐ tainability & Communication department and submitted to the Review Board Sustainability and the Board of Management.
Implementation of due diligence around sustainability:
- In 2024, the Board of Management received four updates on the ongoing due diligence processes around sustainability. These updates focused particularly on supply chain risks, environmental and social standards, and regulatory developments.
- In the future, measures to identify and reduce sustainability risks will be continuously reviewed and adjusted.
Results and effectiveness of strategies, measures and targets:
- Strategies: The sustainability strategy of Biotest AG will be reviewed annually from 2025 based on internal and external de‐ velopments. Adjustments will be made based on current scientific knowledge, stakeholder feedback and regulatory require‐ ments.
- Measures: The implementation of sustainability‐related measures should be evaluated on a regular basis. The defined KPIs for resource and energy efficiency and circular economy should be reported to the Management Board on a quarterly basis.
- Targets: Progresstowards targets,such asreducing CO₂ emissions or improving energy efficiency, is monitored and compared with original planning figures.
These regular reports ensure that sustainability issues are fully integrated into corporate management and that strategic decisions are based on facts.
Consideration of IROs in corporate strategy
The Board of Management actively involve the IROs in monitoring the corporate strategy, in decisions on major transactions and in the risk management process. This process entails a balanced evaluation of the trade‐offs between impacts, risks, and opportunities. It is particularly concerned with integrating sustainability criteria into business decision‐making while considering the long‐term environ‐ mental and social implications. Forinstance,sustainability criteria are considered in investment decisions, particularly regarding resource efficiency, energy consumption and regulatory risks.
Key IRO issues addressed by the Board of Management and Supervisory Board
The Board of Management and the Supervisory Board of Biotest AG addresses the material topics, that are relevant to the long‐term sustainable development of the company once a quarter. These include, in particular:
Climate‐related risks
- Physicalrisks: The impact of climate change on production and supply chain processes, particularly regarding extreme weather events and potential shortages of raw materials.
- Transitional risks: Changes in the regulatory landscape (e.g. carbon pricing, new climate change regulations) and their impact on operational processes and investment strategies.
- Strategic measures: Complete integration of climate‐related ESG risks into the group‐wide risk management system, align‐ ment of the business strategy with decarbonisation pathways, and a 2 % annual reduction in Scope 1 and Scope 2 emissions.
Social responsibility in supply chains
- Human Rights and Labour Standards: Ensure that all Biotest Group's suppliers comply with international social and environ‐ mental standards (e.g. UN Global Compact, ILO Core Labour Standards).
- Risk management: Conducting regular risk analyses and implementing a rating system to monitor and minimise social and environmental risks in the supply chain.
- Stakeholder engagement: We will work closely with external partners, NGOs and interest groupsto improve transparency and due diligence along the entire value chain.
Regulatory requirements in target markets
- Compliance with national and international regulations: Monitoring and adapting corporate strategy to new legal require‐ ments in key target markets, particularly in the EU, North America and Asia.
- Product registration and compliance: Consideration of new regulatory requirements in the field of biopharmaceutical produc‐ tion, e.g. from the FDA (USA) and European Medicines Agency (EMA) (EU).
- Internal control and governance: Integrate regulatory risk into the Enterprise Risk Management (ERM) system and provide regular training for managers to comply with new regulations.
Governance structure and responsibilities
The review of these material IROs is carried out in close cooperation between the Board of Management, the Supervisory Board and the relevant departments. The following factors are taken into consideration:
- Regular meetings held to monitor risk,
- Sustainability and compliance teams are involved,
- Measures to minimise risk considered in the strategic planning process.
Biotest AG employs a structured approach to ensure that significant risks and opportunities are identified, evaluated and actively man‐ aged at an early stage.
Inclusion of sustainability‐related performance in incentive systems (GOV‐3)
Biotest AG has designed the integration of sustainability‐related performance into its incentive systems as follows:
The incentive systems for members of the Boad of Management include clear targets for improving energy efficiency. Performance is measured againstspecific sustainability targets,such asreducing Scope 1 and Scope 2 emissions. Sustainability performance parameters are an integral part of the remuneration policy and are reviewed annually.
The incentive system for the members of the Board of Management includes both financial and non‐financial criteria. The importance of sustainability targets is reflected in the long‐term variable remuneration of the members of the Board of Management. On average, 7.5% of the achievement of the long‐term targets is allocated to the attainment of sustainability targets. These targets are set and regularly reviewed by the Supervisory Board to ensure that they correspond to the strategic priorities of the company.
Governance and transparency
Biotest AG employs a transparent governance strategy to effectively manage sustainability risks. The Board of Management is actively involved in monitoring and managing ESG issues, and the relevant responsibilities are clearly defined. Sustainability decisions are regu‐ larly reviewed and supported by an internal control system that aims to continuously improve reporting.
Declaration of due diligence (GOV‐4)
Biotest AG has established a structured procedure for fulfilling its duty of care and has documented this in various company‐wide docu‐ ments. Due diligence is integrated into the corporate strategy and business model:
- Biotest has voluntarily committed to the areas of sustainability and human
- Biotest AG's statement of policy on the Supply Chain Due Diligence Act
- Code of Conduct for Biotest suppliers in the area of sustainability
Our due diligence measures are systematically integrated into our corporate strategy and business model. The focusis on environmental, social and ethical aspects. Since 2017, we have been continuously analysing the most important sustainability aspects and negative impacts along our value chain. Building on this, we aim to identify risks at an early stage so that we can manage them in a targeted manner.
In future, affected interest groups will be involved in risk assessments. Regular dialogues, workshops, and other formats will be used or introduced to achieve this aim. For the 2024 reporting period, the stakeholder perspective for the various interest groups was repre‐ sented by the internal departments, which take an external perspective of their interest groups.
We are already implementing targeted measures to reduce negative impacts, including:
- Environmental protection: Reduction of emissions and sustainable use of resources.
- Social responsibility: Fair working conditions, diversity and training in human rights.
- Supply chain management: Risk analysis, questionnaires
The effectiveness of the measurestaken so far isregularly reviewed and the results are transparently communicated in the sustainability report.
| Due diligence | |
|---|---|
| Key elements of due diligence | Paragraphs in sustainability reporting |
| a) Integration of due diligence into governance, strategy and business model |
ESRS 2 GOV‐1, GOV‐3, SBM‐3 → Governance structure and integraƟon of sustainability into business strategy |
| b) Involvement of affected stakeholders in all key steps of due diligence |
ESRS 2 SBM‐2, SBM‐3, IRO‐1, G1‐1 → Stakeholder engagement and materiality analysis |
| c) Identification and assessment of adverse impacts | ESRS 2 IRO‐1, ESRS E5‐1 → IdenƟficaƟon of negaƟve social and environmental impacts |
| d) Measures to address these adverse impacts | ESRS S1‐1, E1‐2 → PrevenƟon and miƟgaƟon measures, risk management |
| e) Tracking the effectiveness of these efforts and communication |
ESRS 2 IRO‐2, ESRS G1‐2, ESRS 1‐5 → Monitoring, indicators and reporting on progress |
Risk Management and Internal Controls in Sustainability Reporting (GOV‐5)
Biotest AG has started to implement standardised procedures to ensure accurate and reliable sustainability reporting. These measures are from the next reporting year and ensure that ESG data is accurately collected, verified and reported. Biotest AG is currently in the early stages of integrating risk management with sustainability management. The following is a detailed description of the measures that have already been implemented and those that are planned for the next reporting period and beyond.
Risk management and internal control procedures and systems
The Biotest AG has a company‐wide risk management system in place. In the reporting year 2024, the company began integrating ma‐ terial ESG risks and risks in the control and management of sustainability reporting into this system. To this end, the data collection processes in the participating departments and subsidiaries were evaluated and assessed in 2024. Moving forward, data integrity is to be ensured by means of standardised ESG software surveys.
The assessment of risks to sustainability reporting takes into account the probability of errors in reporting and the potential impact on the transparency and quality of sustainability reporting. Moving forward, the risk assessment will be based on a specific prioritisation methodology.
Important risks and mitigation strategies
Identified risks:
- Incorrect collection of ESG data due to inadequate data systems or insufficient collection methods.
- Insufficient documentation of data sources and reporting procedures.
- Delays in data collection that could affect reporting.
- Duplicate data collection processes due to different reporting periods (Grifols / Biotest AG)
Mitigation strategies:
- Centralised ESG data management system: Commenced implementation of a central platform (Sygris) to collect and process ESG data.
- For the next reporting period, a process will be put in place to collect ESG data on an ongoing basis throughout the year and to review the data during the year.
- Training for those in positions of responsibility: regular training for employees in the sustainability, risk management, compli‐ ance and other relevant departments is to be introduced.
- Control mechanisms: For the time being, manual plausibility checks and audits are planned to ensure data quality and accu‐ racy. A decision on the automation of these processes will have to be made in subsequent years.
Integration of the results into internal functions and processes
The results of the risk assessment and internal controls are already partially integrated into the relevant internal functions and processes through regular meetings, reports from the Sustainability Review Board and voting on further measures, and will be systematically inte‐ grated in the coming years. These measures include:
- Risk Management department: Assessment and prioritisation of ESG risks.
- Sustainability department: Development and implementation of risk‐mitigating measures.
- Compliance department: Ensuring compliance with legal and regulatory requirements.
Integration is promoted by regular coordination meetings between these departments.
Regular reporting to the Board of Management and the Supervisory Board
In the past, the Corporate Sustainability department's quarterly reporting to the Board of Management (which has chaired the Review Board Sustainability since mid‐2024) included the current status of the materiality analysis and the reporting process. In the future, the relevant bodies will be provided with a quarterly overview of the identified risks in sustainability reporting, the results of the measures implemented, including successful plausibility checks and audits, as well as recommendations for adjustments to existing processes to further reduce the potential for errors in cooperation with risk management.
Strategy, business model and value chain (SBM‐1)
Biotest is a supplier of biological products derived from human plasma. Biotest's products are used primarily in the areas of clinical immunology, hematology and intensive care. They are used to specifically treat people with serious and often chronic diseases, so that they can usually lead a normal life.
In the areas of expertise in which we are active, we are involved in preclinical and clinical development, manufacturing and worldwide marketing. We develop and produce at our main site in Germany. In addition, we have representation worldwide through our own distribution subsidiaries and cooperation partners.
Headquarters and subsidiaries
In addition to the company headquarters in Dreieich (near Frankfurt, Germany), Biotest has its own subsidiaries in four European coun‐ tries (Austria, Switzerland, Hungary and the Czech Republic).
Production site
The Biotest production site islocated in Dreieich, Germany, at the company's headquarters. Together with its partners, Biotest processes up to 1.5 million liters of blood plasma per year. As part of the "Biotest Next Level" investment project, Biotest has doubled its global capacity at the Dreieich site to up to 3 million liters of plasma and is successively ramping up the new production plant until 2026.
Its most important markets are in Europe, North America and Asia, and it primarily supplies hospitals, pharmacies and laboratories. There has been no change in this respect compared to previous reporting periods.
Biotest AG takes sustainability aspects into account in strategic decisions and has implemented specific measures to integrate environ‐ mental and social factors into its long‐term business strategy. The strategy outlines the sustainability goals of Biotest AG and includes measures for investments in climate‐friendly production processes, the sustainable development of skilled workers, supply chain analy‐ sis and development, and initiatives to promote ethical business practices. The risk assessment identified material ESG risks, including regulatory requirements, climate risks and demographic challenges such as location development and the shortage of skilled workers.
In the future, the long‐term financial planning of Biotest AG will be subject to regular review and adaptation in line with the strategic corporate goals, with due consideration given to sustainability aspects. Detailed measures to ensure implementation and to measure success are currently being developed and will be defined in the subject‐specific strategic sustainability plans.
Value Chain
Upstream activities: Procurement of plasma from certified suppliers and plasma collection in company‐owned centres. The Biotest Group currently operates 40 of its own plasma collection centres in Europe and is continuously expanding its capacities. In addition to plasma from its own centres, Biotest procures raw materials from other suppliers and participates financially in the development of new collection centres with partners.
Own Production: Processing, quality assurance and sterile filling, supported by sustainable innovations. The production of plasma pro‐ teinstakes place primarily at the headquartersin Dreieich, Germany, as well asthrough contract manufacturing agreements with Prothya Biosolutions Belgium in Brussels, Belgium. To expand manufacturing capacity, Biotest has implemented the Biotest Next Level (BNL) project. Since November 2022, the intravenous immunoglobulin Yimmugo® has been produced in the new Biotest Next Level production facility. As part of the international expansion, an important milestone was reached in September 2023 with the acceptance of the marketing authorization application for Yimmugo® by the US Food and Drug Administration (FDA). Further steps toward obtaining the Biologics License Application (BLA) were taken in 2024. Through international expansion and the planned FDA approval, the availability of Yimmugo® will be extended worldwide, ensuring that more patients with primary and secondary immunodeficiencies gain access to this life‐saving therapy. Expanding market access, particularly in the United States, strengthens Biotest's global market position and opens significant growth opportunities. Entering new markets also promotes international scientific collaboration and the further de‐ velopment of plasma‐derived products.
Downstream Activities: Global logistics and distribution of products. The Biotest Group markets its products worldwide and maintains its own distribution companies in three European countries. The distribution structures of five former distribution companies in Europe and South America, which now belong to Grifols S.A., continue to be used by Biotest. Global distribution activities are managed centrally from the headquarters in Dreieich and supported by local partners.
Within this value chain, Biotest ensures that all relevant production and distribution steps are covered, sustainable processes are inte‐ grated, and regulatory requirements are met.
The sustainability strategy of Biotest AG includes the following goals for the coming years:
Environmental Goals: 20 % CO₂ reduction (Scope 1 and 2) and 2 % lower water abstraction annually by 2035, based on the base year 2023. Additionally, energy consumption isto be reduced by 20 % by 2035, and waste production isto be decreased by 2 % per year (base year 2023). These targets specifically apply to the main production sites in Dreieich (Germany), Belgium, and Hungary, as well as the plasma collection centers in Europe.
Social Goals: Health and safety of donors, patient safety, and health. The health and safety of donors are ensured through well‐trained staff and preventive health screenings. Promotion of diversity, equal opportunities, and employee development. Examples include a DE&I mentoring program and the introduction of leadership training. In addition, a competency model has been introduced, which is integrated into onboarding plans and training programs. An internal mentoring program is being established to provide targeted support for at least 50 employees. The sales activities in Germany are complemented by regional training programs to ensure sustainable work‐ force development. Furthermore, Biotest is actively engaged in social programs to improve access to biopharmaceutical products in underserved regions.
Governance: Measures for corruption prevention, protection of whistleblowers, and transparent decision‐making processes. A robust compliance system ensures adherence to ethical standards across all business processes, particularly in plasma collection and distribu‐ tion. The SpeakUp tool is being implemented for reporting compliance violations, with the goal of identifying five documented whistle‐ blower reports by 2025.
The ESG strategy of Biotest AG thus integrates environmental, social, and governance aspects into all key business areas and ensures that sustainability goals are implemented while taking into account the most important product groups, geographic markets, and stake‐ holder relationships.
Number of Employees: 2,666 (Headcount) as of 31 December 2024
Table IX (S1‐AR55): Employees by Country:37
| 21 |
|---|
| 217 |
| 314 |
| 2,041 |
| 2023 |
Biotest AG generatesitsrevenuesin the ESRS sector of pharmaceutical manufacturing. Revenuesin 2024 amounted to 726,228,042.69 €. Biotest AG does not generate any revenues from fossil fuels, chemical production, controversial weapons, or tobacco.
Stakeholder Interests and position statements (SBM‐2)
The integration of stakeholders into the ESG strategy of Biotest AG is a key component of sustainability reporting and takes into account the requirements in accordance with SBM‐2. Biotest AG has identified key stakeholder groups, including:
| Identification and involvement of stakeholders | |
|---|---|
| Key stakeholdes | Methods of stakeholder engagement (examples) |
| Employees | Workshops, one‐on‐one meetings |
| Customers | Transparent information and communication, project communication, industry trade fairs |
| Suppliers | Code‐of‐Conduct, contract negotiations |
| Skilled workers | Recruitment and training programs, development programs |
| Owners/ Shareholders | General meeting, company website, dialogue |
| Analysts/ Investors | Website, investor meetings |
| Local Communities | Transparent information and communication, joint planning, donations |
| Authorities, governments and public administration, regulatory and supervisory bodies |
Compliance processes, GxP processes, regulations |
Stakeholder engagement takes place on a regular basis and is implemented in different ways depending on the area of expertise. These include direct consultations, workshops and topic‐specific dialogue formats. In the future, the insights gained will be collated and com‐ prehensively analysed across the company to integrate stakeholder interests holistically into the ESG strategy.
The existing and future integration aims to understand the interests and needs of stakeholders and incorporate them into strategic decision‐making processes. In the future, this must include a detailed assessment of stakeholder expectations, as well as the develop‐ ment and implementation ofspecific measures to ensure continuous improvement of the corporate strategy in line with ESG objectives.
Consideration of stakeholder results
The results of the surveys and workshops are already integrated into the ESG strategy to a certain extent. This will be expanded in the following reporting periods. The following have already been integrated:
- Enhanced transparency across the supply chain through more detailed reporting and disclosure of ESG‐related information.
- Increased engagement and education on sustainability topics, with targeted communication initiatives to raise awareness among employees and external stakeholders.
- Measures to improve workplace conditions, including ergonomic optimisations, mental health programmes and initiatives to improve the work‐life balance.
The following key issues have been highlighted in relation to stakeholder interaction:
- Environment: Expectations of reduced emissions, efficient use of resources and a stronger commitment to biodiversity and a circular economy.
- Social: Demand for fair remuneration, increased diversity and equality, and sustainable talent development.
- Governance: Need for transparent decision‐making processes, stronger compliance mechanisms and improved ethical guide‐ lines to combat corruption.
Impact on strategy and business model
Based on the stakeholders' interests, strategic adjustments were made, including:
- Implementation of various measures to transform production towards renewable energies and resource‐efficient processes. This includes, among other things, investments in modern, energy‐efficient technologies and the optimisation of production processes to reduce waste and emissions.
- Development of sustainable site concepts, including programmes to improve resource efficiency. These include water recy‐ cling systems, energy‐efficient building infrastructure and comprehensive initiatives for sustainable mobility.
- Additional measures for stakeholder engagement, such as awareness‐raising campaigns in production, an energy day for all employees and online training for subsidiaries on current ESG requirements. This helps to raise awareness of sustainable business practices and to actively involve the workforce.
Proposed steps include:
- Introduction of a comprehensive participation process for employees of Biotest AG to include their perspectives and sugges‐ tions in decision‐making processes at an early stage.
- Strongerintegration of ESG objectivesin strategic decisions by 2025 to ensure thatsustainable principles are firmly established in the long term.
- Step‐by‐step integration of ESG measures in the programmes of the specialist departments by 2026 to ensure effective and sustainable implementation.
Implementing these measures is expected to increase stakeholder satisfaction, strengthen the company's reputation and sustainably consolidate relationships with key stakeholders. This contributes to the company's long‐term competitiveness and innovative strength.
The Board of Managment receives quarterly reports on the results and recommendations from participation processes. Reporting takes place within the Review Board Sustainability meetings through the Corporate Sustainability team and the relevant specialist de‐ partments to the Board of Management, which in turn informs the Supervisory Board. This ensures a continuous evaluation of ESG measures and actively involves corporate leadership in the sustainable transformation process.
Interests of employees
The interests of employees, including job security, fair compensation and further development, are taken into account through contin‐ uous dialogue and systematic integration into the strategy. Examples:
Improved working conditions: Modernisation of the working environment (Coffee Corner, Modern Workplace project)
Diversity management: Introduction of a DE&I mentoring programme
Key IROs and how they link to the value chain (SBM‐3)
Biotest AG identifies significant impacts, risks and opportunities (IROs) in the areas of climate risks (greenhouse gas emissions, resource consumption),social aspects(working conditions, diversity, health and safety) and governance (compliance,supply chain management). These risks and opportunities are localized to a greater or lesser extent along the entire value chain, from raw material procurement to production and logistics.
Asthe central production site of Biotest AG in Dreieich, the main risksin the areas of emissions, health and safety, and working conditions are particularly relevant here. Biotest focuses on energy efficiency measures and sustainable production methods.
In the upstream value chain, the greatest challengeslie in ensuring compliance with health and safety standardsfor donors and ensuring compliance within the supply chain. The same applies to the downstream value chain, where the focus is also on compliance issues, the recycling and use of resources, and patient health and safety, particularly regarding quality assurance and the environmentally friendly design of products.
Biotest operates in a regulated European environment that demands high environmental and social standards. The choice of location in Dreieich provides access to qualified specialists, regulatory security and a stable infrastructure. At the same time, there are challenges due to rising energy prices and changing legal requirements. Biotest AG continued to work on identifying risks and opportunities in the upstream and downstream value chain and on working with suppliers, partners and stakeholders to make improvements.
The current and expected impacts include adjustments to production methods to meet stricter climate standards and investments in sustainable supply chains. Strategic measures are aimed at reducing environmental pollution and strengthening social responsibility.
Negative and positive effects on the business model
Negative effects:
- Environmental impacts: The production of plasma protein therapeuticsis associated with high energy and water consumption. In addition, greenhouse gas emissions arise, particularly from energy‐intensive processes, refrigeration systems and the transport of plasma and end products.
- Resource consumption: Production requires significant amounts of ethanol, packaging materials and water, resulting in a high ecological footprint.
- Waste generation: Despite high recycling rates, unavoidable production waste is generated,some of which hasto be thermally recycled.
Positive effects:
- Improving quality of life: By producing innovative plasma products such as Yimmugo®, Biotest contributes to the treatment of serious immune disorders, thus improving the health and quality of life of patients.
- Future‐proof jobs: The state‐of‐the‐art Biotest Next Level production facility creates long‐term jobs and secures Dreieich as a business location.
- Sustainability measures: Biotest actively contributes to reducing environmental pollution by investing in energy efficiency, circular economy and sustainable supply chains.
Alignment with the corporate strategy
- Sustainability strategy as part of production: Biotest has developed sustainability goals that will be directly integrated into production planning and plant structure planning in the future. Implementation will be achieved through clear measures such as energy‐efficient technologies, reducing water consumption and minimising waste.
- Crisis‐proof supply chains: Through long‐term partnerships with suppliers, Biotest strengthens the resilience of the supply chain, reduces dependencies and minimises supply bottlenecks.
- Maintaining and creating jobs: Sustainable corporate development not only secures existing jobs, but also enables the com‐ pany to grow by expanding new production capacities.
Consideration of the effects over different time horizons
Short‐term (1 year):
- Pollution: Direct emissions from production and transport occur immediately and have a short‐term impact on the carbon footprint.
- Resource consumption: The high demand for ethanol, packaging materials and water causes direct environmental damage.
- Waste generation: Production waste is generated continuously and must be disposed of or recycled immediately.
- Quality of life: With the immediate use of plasma productssuch as Yimmugo®, patients benefit from better treatment options in the short term.
- Sustainability measures: Initial energy efficiency measures and circular economy projects are starting to show measurable results in the short term.
Medium‐term (1‐5 years):
- Environmental impact: Emissions and energy consumption can be reduced, but not eliminated, in the medium term through efficiency improvements and more sustainable technologies.
- Resource consumption: Water and material consumption can be reduced in the medium term by optimising production.
- Waste generation: Improved recycling processes and closed‐loop solutions can reduce waste generation in the medium term.
- Future‐proof jobs: The Biotest Next Level production facility will reach full capacity, stabilising employment.
- Sustainability measures: Investments in sustainable supply chains and energy efficiency will deliver tangible environmental benefits in the medium term.
Long‐term (5+ years):
- Environmental impact: In the long term, the production process remains energy intensive, but the use of new technologies can further reduce the environmental footprint.
- Resource consumption: Strategic changes in sourcing and production could lead to the use of more sustainable materials in the long term.
- Waste generation: New recycling and closed‐loop systems could enable a virtually closed value chain in the long term.
- Preserving and creating jobs: Long‐term business development secures existing jobs and creates new capacity.
- Sustainability measures: Long‐term integration of sustainable production methods leads to a reduced overall footprint.
Significant impact drivers
Production: The energy‐intensive production of plasma proteins is the largest contributor to the company's environmental footprint.
Financial impact and investment plans
The current financial implications and investment measures of Biotest AG include:
- Increased operating costs due to rising energy prices, growing production capacities and stricter ESG regulations.
- Energy efficiency and resource conservation programmes to reduce energy consumption.
- Investments in energy efficiency programmes to optimise production methods.
- Modernisation of production facilities as part of a plant structure plan, including improvement of building infrastructure and implementation of sustainable technologies.
Resilience analysis and comparison to the previous year
As part of the double materiality analysis, Biotest AG has identified, analysed and evaluated significant risks and opportunities. Our strategic concepts and measures are designed to ensure that our business model remains resilient. The resilience analysis confirms that our strategy can manage material risks and exploiting opportunities. Regarding adaptation to climate change (E1), we have thoroughly analysed the resilience of the strategy and the business model.
Biotest AG has conducted an initial qualitative analysis of the resilience of its strategy and business model. This involved an assessment of internal and external risks and opportunities, including:
- Climate change (e.g. physical risks from extreme weather such as heat waves or heavy rainfall events)
- Rising energy prices and their impact on production costs
- Regulatory requirements (e.g. stricter climate standards and ESG reporting requirements)
- Market developments (e.g. increasing demand for sustainable products and circular economy)
- Supply chain risks due to geopolitical uncertainties and scarcity of raw materials
The analysis shows that the business model of Biotest AG is highly resilient, in particular due to the following factors:
- Investments in transformation measures such as energy‐efficient production facilities and sustainable logistics strategies.
- Diversification of the product range to reduce dependencies and exploit new market opportunities.
- Strategic partnerships and sustainable supply chains that ensure stable security of supply.
- Planned investments in green technologies to reduce CO₂ emissions and increase resource efficiency.
Time horizons
Short‐term (1–5 years):
- Implementation of initial measures to increase energy efficiency and circular economy.
- Adaptation to new regulatory requirements by expanding ESG compliance structures.
Medium‐Term (5‐10 years):
- Conversion of production processes to more climate‐friendly technologies.
- Expansion of renewable energy sources at the production site in Dreieich.
- Development of new sustainable products and use of sustainable packaging materials.
Long‐term (10+ Jahre):
- Largely climate‐neutral production processes and a 90 % reduction in CO₂ emissions by 2045.
- Transformation of the entire supply chain to sustainable and resilient procurement models.
- Long‐term adaptation of the corporate strategy to changing climate conditions and market requirements.
The quantitative analysis will be further developed in the coming years to determine the specific financial impact of the identified risks and opportunities.
All material IROs are fully covered by the ESRS disclosure requirements. Additional corporate characteristics, such as the health, cyber‐ security and safety of donors, are described in more detail in the topic standards G1 and S1. Further information on Biotest AG's material IROs is listed in tabular form at the end of this chapter.
Key topics according to the ESRS
Biotest AG has conducted a comprehensive analysis of the significant impacts, risks and opportunities in the area of sustainability. The main risks include dependence on global supply chains and regulatory changes with regard to sustainable production methods. At the same time, opportunities arise from investments in innovative, sustainable biopharmaceutical production processes and increased mar‐ ket demand for environmentally friendly medicines.
In addition, potential impacts on biodiversity and affected communities were examined. On this basis, Biotest AG is developing measures to minimise negative ecological impacts, including the development of a strategy for sustainable energy procurement. The corporate strategy also considers long‐term risks that could arise from climate change, including physical risks to production facilities and supply chain interruptions. In addition, economic and technological opportunities are used to develop innovative products with a lower environmental impact.
Double materiality analysis
In the period from June to October 2024, the company conducted a double materiality analysis that meets the requirements of the European Sustainability Reporting Standards (ESRS). The Board of Management approved the results on 11 December 2024.
This analysis forms the basis for sustainability reporting for the 2024 financial year and considers both the potential and actual impacts of Biotest on people and the environment, as well as the risks and opportunities for Biotest.
Methodology and implementation of the materiality analysis (IRO‐1)
The materiality analysis was carried out in a structured process:
- Longlisting of relevant topics: Based on the sustainability aspects of the ESRS 1 AR 16, Global Reporting Initiative (GRI) and benchmarks with competitors and the parent company, a comprehensive list of sustainability aspects was created that could potentially have a significant impact on the company or its stakeholders.
- Identification of stakeholders: Stakeholders were identified. Their interests were represented by employees during the ma‐ teriality analysis.
Identification of the effects, risks and opportunities (IROs)
The topics were identified and systematically evaluated along the entire value chain, with the identification and evaluation of the IROs taking the following points into account:
Specific activities with increased risk, such as plasma storage, energy‐intensive production and supply chains.
This year, the majority of consultations with external experts and stakeholders were carried out by internal representatives, with the aim of gaining a better understanding of the affected groups and carrying out a well‐founded prioritisation. The negative impacts were given priority according to their extent and probability, and the positive impacts according to their extent and probability. This approach enabled the prioritisation of smaller measures that contribute to increasing energy efficiency in the short term, such as the installation of a further photovoltaic system and measures to use water more efficiently in production.
Materiality determination method
Biotest began integrating the requirements of dual materiality into its corporate reporting in 2024. Material information has been iden‐ tified using an evaluation process that includes both sustainability materiality (inside‐out perspective) and financial materiality (outside‐ in perspective). The criteria in ESRS 1 section 3.2 were applied and compared with internal thresholds.
Description of the materiality thresholds
The following criteria were used to determine the materiality thresholds:
-
Sustainability‐related materiality: A sustainabilty aspect was considered material if significant negative or positive impacts on people and the environment were identified. The following factors were considered in the assessment:
- o Extent: Severity of the impact
- o Scope: Number of people or natural resources affected
- o Remediation potential: Difficulty of minimising the damage
- o Probability: Probability of occurrence within the next 10 years
-
Financial materiality: A sustainability aspect was classified as material if the associated risks or opportunities have a high probability or significant financial impact on Biotest or its stakeholders. The assessment was based on the following parame‐ ters:
- o Net probability: Probability of a financial risk occurring after countermeasures
- o Financial impact: Possible effects on cash flow, EBITDA and investment volume
- Regulatory and societal relevance: topics with high legal significance or broad public interest were also prioritised.
The results of this analysis were validated by the sustainability department and approved by the management board. An annual review is carried out to take account of changes in the regulatory environment and in stakeholder expectations.
In accordance with the ESRS, reporting is carried out along ESG topics according to the principle of double materiality:
- Inside‐out perspective: impact of corporate activities on the environment and society.
- Outside‐in perspective: financial risks and opportunities for the company arising from ESG factors.
Relevant impacts on people and the environment do not necessarily occur at the same time as financial impacts. Therefore, both per‐ spectives are to be analysed separately but equally.
Methodology for assessing materiality
The following mathematical calculations were used to assess the materiality of the impacts:
- Materiality of the impact = severity of the impact x probability of occurrence
- Severity of the impact = extent + scope + remedy
The combination of assessment criteria varies depending on the type of impact:
- Actual negative impacts: Extent, scope, scope for mitigation
- Potential negative impacts: Extent, scope, scope for mitigation, probability of occurrence
- Positive impacts: Combination of scope, range and probability
In the case of possible negative impacts on human rights, for example the severity of the impacts takes precedence over the probability of occurrence.
Integration of the materiality analysis
- ESG topics with high materiality are integrated into the corporate strategy.
- Sustainability risks are included in the risk management system (RMS) and the internal control system (ICS).
The materiality analysis is reviewed and updated annually to reflect changes in the regulatory environment and stakeholder expecta‐ tions.
Link to the risk management system/internal control systems
In 2024, Biotest began integrating ESG risks and opportunities into the risk management system (RMS) and the internal control system (ICS). In 2024, the identified risks were still being assessed using a different methodology from that of risk management. Full integration into the RMS (including harmonisation of the assessment) is planned for the coming years, so that ESG aspects will be fully considered in strategic planning in the future.
Analysis of impacts, dependencies, risks and opportunities
Biotest systematically analyses the relationships between its impacts, dependencies and the resulting risks and opportunities. The foun‐ dations for this were laid in 2024:
- Identification of direct and indirect dependencies along the value chain
- Analysis of economic risks resulting from environmental and social impacts
- Start of the integration of these findings into risk assessment and strategic planning
Full integration into risk management will take place in 2025.
Assessment of financial materiality
Regular review and integration into strategic and operational processes
The following criteria were defined in 2024 to determine financial materiality:
- Qualitative aspects: Relevance of ESG risks for the industry, impact on compliance, market position and reputation.
- Quantitative thresholds: Definition of financial thresholds such as sales, EBITDA or investment volume to assess material ESG risks.
- Risk assessment: Application of scenario and sensitivity analyses to better understand the potential financial impact of sus‐ tainability risks.
Compared to the previous reporting period, the materiality analysis and the identification of risks and impacts have been aligned with the requirements of the ESRS. The materiality analysis and risks, as well as the methodology, will be reviewed in the course of 2025.
Internal control procedures for risk management
ESG risk management will be further developed, in particular through:
- ESG radar for early risk detection
- Risk minimisation measures
- Quarterly reporting to the management
Documentation and control
The IROs have been documented company wide. In the future,systematic recording, assessment and control of ESG risksisto be ensured by integrating them into the ICS and RMS.
Non‐material topics
The following assessment is based on a comprehensive materiality analysis by Biotest AG that took into account the entire value chain and all material sustainability aspects. The following topics were classified as not material:
Environment (E topics)
- E2 Environmental pollution: Biotest AG has no significant direct or indirect impact on environmental pollution because its production processes are subject to strict regulatory requirements and are continuously optimised. Relevant emissions and waste are addressed in the material environmental topics.
- E4 Protection of biodiversity: Biotest AG has no direct or significant impact on sensitive ecosystems or protected areas. Production sites and supply chains were analysed for this and no significant points of contact with biodiversity‐critical areas were identified.
Social (S topics)
- S2 Workers in the value chain: Biotest AG has not been able to identify any significant social risks, as the supply chain is highly regulated, and most employees are directly employed. Employees at the plasma centres are Biotest AG's own employ‐ ees. Their concerns are reported under S1.
- S3 Impact on communities: The business activities of Biotest AG have no significant direct influence on local communities. The company complies with all relevant social and regulatory standards, but no significant independent impact on communi‐ ties has been identified.
The topics mentioned above were classified as not material. However, Biotest AG will continue to monitor regulatory developments and will reassess the situation if there are any relevant changes.
The following table contains ESRS data pointsthat arise from further EU legislation and classifiesthem in terms of materiality and location in the sustainability declaration:
| Data points from other EU legislation | |||||||
|---|---|---|---|---|---|---|---|
| References | |||||||
| Disclosure Sustainability declaration requirement |
SFDR | 3 Pillar |
Benchmark‐ regulation |
law climate EU |
material/ immaterial |
Page of the sustainability declaration |
|
| ESRS 2 GOV‐1 | Gender diversity on the management and supervisory bodies, paragraph 21 (d) |
x | x | material | 49 | ||
| ESRS 2 GOV‐1 | Percentage of members of the management body that are independent, paragraph 21 (e) |
x | material | 49 | |||
| ESRS 2 GOV‐4 | Due diligence statement, paragraph 30 | x | material | 53, 54 | |||
| ESRS 2 SBM‐1 | Investments in activities related to fossil fuels, paragraph 40 (d)i |
x | x | x | material | 56, 57 | |
| ESRS 2 SBM‐1 | Involvement in activities related to chemical production paragraph 40 (d) ii |
x | x | material | 56, 57 | ||
| ESRS 2 SBM‐1 | Involvement in activities related to controversial weapons, paragraph 40 (d) iii |
x | x | immaterial | 56, 57 | ||
| ESRS 2 SBM‐1 | Involvement in activities related to cultivation and production of tobacco, paragraph 40 (d) iv |
x | immaterial | 56, 57 | |||
| ESRS E1‐1 | Transition plan to reach climate neutrality by 2050, paragraph 14 |
x | material | 79, 80 | |||
| ESRS E1‐1 | Undertakings excluded from Paris‐aligned Benchmarks, paragraph 16 (g) |
x | x | material | 79 | ||
| ESRS E1‐4 | GHG emission reduction targets, paragraph 34 | x | x | x | material | 80 | |
| ESRS E1‐5 | Energy consumption from fossil sources disaggregated by sources (only high climate impact sectors), paragraph 38 |
x | material | 82 | |||
| ESRS E1‐5 | Energy consumption and mix, paragraph 37 | x | material | 82 | |||
| ESRS E1‐5 | Energy intensity associated with activities in high climate impact sectors, paragraphs 40 to 43 |
x | material | 82, 83 | |||
| ESRS E1‐6 | Gross scope 1, 2, 3 and total GHG emissions, paragraph 44 |
x | x | x | material | 85, 86 | |
| ESRS E1‐6 | Gross GHG emissions intensity, paragraphs 53 to 55 | x | x | x | material | 85, 86 | |
| ESRS E1‐7 | GHG removals and carbon credits, paragraph 56 | x | immaterial | ‐ | |||
| ESRS E1‐9 | Exposure of the benchmark portfolio to climate‐ related physical risks, paragraph 66 |
x | Phase‐in | ‐ | |||
| ESRS E1‐9 | Disaggregation of monetary amounts by acute and chronic physical risk, paragraph 66 (a) ESRS E1‐9 Location of significant assets at material physical risk, paragraph 66 (c). |
x | Phase‐in | ‐ | |||
| ESRS E1‐9 | Breakdown of the carrying value of its real estate assets by energy‐efficiency classes, paragraph 67 (c). |
x | Phase‐in | ‐ |
| ESRS E1‐9 | Degree of exposure of the portfolio to climate‐ related opportunities, paragraph 69 |
x | Phase‐in | ‐ | |
|---|---|---|---|---|---|
| ESRS E2‐4 | Amount of each pollutant listed in Annex II of the E‐ PRTR Regulation (European Pollutant Release and Transfer Register) emitted to air, water and soil, paragraph 28 |
x | immaterial | ‐ | |
| ESRS E3‐1 | Water and marine resources, paragraph 9 | x | material | 86, 87 | |
| ESRS E3‐1 | Dedicated policy, paragraph 13 | x | material | 87 | |
| ESRS E3‐1 | Sustainable oceans and seas, paragraph 14 | x | material | 87 | |
| ESRS E3‐4 | Total water recycled and reused, paragraph 28 (c) | x | material | 88, 89 | |
| ESRS E3‐4 | Total water consumption in m3 per net revenue on own operations, paragraph 29 |
x | material | 89 | |
| ESRS 2 – SBM‐3 – E4 |
paragraph 16 (a) i | x | immaterial | ‐ | |
| ESRS 2 – SBM‐3 – E4 |
paragraph 16 (b) | x | immaterial | ‐ | |
| ESRS 2 – SBM‐3 – E4 |
paragraph 16 (c) | x | immaterial | ‐ | |
| ESRS E4‐2 | Sustainable land / agriculture practices or policies paragraph 24 (b) |
x | immaterial | ‐ | |
| ESRS E4‐2 | Sustainable oceans / seas practices or policies, paragraph 24 (c) |
x | immaterial | ‐ | |
| ESRS E4‐2 | Policies to address deforestation paragraph 24 (d) | x | immaterial | ‐ | |
| ESRS E5‐5 | Non‐recycled waste paragraph 37 (d) | x | material | 93 | |
| ESRS E5‐5 | Hazardous waste and radioactive waste paragraph 39 | x | material | ‐ | |
| ESRS 2 SBM3 – S1 |
Risk of incidents of forced labour paragraph 14 (f) | x | material | 102, 103 | |
| ESRS 2 SBM3 – S1 |
Risk of incidents of child labour paragraph 14 (g) | x | material | 103 | |
| ESRS S1‐1 | Human rights policy commitments paragraph 20 | x | material | 102, 102 | |
| ESRS S1‐1 | Due diligence policies on issues addressed by the fundamental International Labor Organisation Conventions 1 to 8, paragraph 21 |
x | material | 102, 103 | |
| ESRS S1‐1 | Processes and measures for preventing trafficking in human beings, paragraph 22 |
x | material | 102, 103 | |
| ESRS S1‐1 | Workplace accident prevention policy or management system paragraph 23 |
x | material | 102, 103 | |
| ESRS S1‐3 | Grievance/complaints handling mechanism paragraph 32 (c) |
x | material | 103 | |
| ESRS S1‐14 | Number of fatalities and number and rate of work‐ related accidents paragraph 88 (b) and (c) |
x | x | material | 109 |
| ESRS S1‐14 | Number of days lost to injuries, accidents, fatalities or illness paragraph 88 (e) |
x | material | 108, 109 |
| ESRS S1‐16 | Unadjusted gender pay gap paragraph 97 (a) | x | x | material | 107, 108 |
|---|---|---|---|---|---|
| ESRS S1‐16 | Excessive CEO pay ratio paragraph 97 (b) | x | immaterial | ||
| ESRS S1‐17 | Incidents of discrimination paragraph 103 (a) | x | material | 110, 112 | |
| ESRS S1‐17 | 17 Non‐respect of UNGPs on Business and Human Rights and OECD Guidelines paragraph 104 (a) |
x | x | material | 110 |
| ESRS 2 SBM3 – S2 |
Significant risk of child labour or forced labour in the value chain paragraph 11 (b) |
x | immaterial | ‐ | |
| ESRS S2‐1 | Human rights policy commitments paragraph 17 | x | immaterial | ‐ | |
| ESRS S2‐1 | Policies related to value chain workers paragraph 18 | x | immaterial | ‐ | |
| ESRS S2‐1 | Non‐respect of UNGPs on Business and Human Rights principles and OECD guidelines paragraph 19 |
x | x | immaterial | ‐ |
| ESRS S2‐1 | Due diligence policies on issues addressed by the fundamental International Labor Organisation Conventions 1 to 8 paragraph 19 |
x | immaterial | ‐ | |
| ESRS S2‐4 | Human rights issues and incidents connected to its upstream and downstream value chain paragraph 36 |
x | immaterial | ‐ | |
| ESRS S3‐1 | Human rights policy commitments paragraph 16 | x | immaterial | ‐ | |
| ESRS S3‐1 | non‐respect of UNGPs on Business and Human Rights, ILO principles or OECD guidelines paragraph 17 |
x | x | immaterial | ‐ |
| ESRS S3‐4 | Human rights issues and incidents paragraph 36 | x | immaterial | ||
| ESRS S4‐1 | Policies related to consumers and end‐users paragraph 16 |
x | material | 117 | |
| ESRS S4‐1 | Non‐respect of UNGPs on Business and Human Rights and OECD guidelines paragraph 17 |
x | x | material | 117 |
| ESRS S4‐4 | Human rights issues and incidents paragraph 35 | x | material | 119 | |
| ESRS G1‐1 | United Nations Convention against Corruption paragraph 10 (b) |
x | material | 123, 124 | |
| ESRS G1‐1 | Protection of whistle‐ blowers paragraph 10 (d) | x | material | 123, 124 | |
| ESRS G1‐4 | Fines for violation of anti‐corruption and anti‐bribery laws, paragraph 24 (a) |
x | x | material | 127 |
| ESRS G1‐4 | Standards of anti‐ corruption and anti‐ bribery paragraph 24 (b) |
x | material | 127 |
The following overview shows the material topics, risks, opportunities and impacts in accordance with the ESRS requirements, catego‐ rised by topic area and along the value chain:
| Material topics for CSRD reporting | ||||||||
|---|---|---|---|---|---|---|---|---|
| Subtopic | IRO‐ Type |
Time horizon | Description of the impact | Actual/ poten‐ tial |
Stage of value chain | |||
| E1 – Climate change | ||||||||
| climate change adaptation |
Risk | Medium to long‐term |
Increased operating costs and/or investments required to adapt to climate change, in particular the need for cooling to combat temperature increases (taking into account high emission scenarios) |
Potential | Own business activity | |||
| Climate protec‐ tion |
Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Contribution to global warming due to the company's Scope 1 and Scope 2 GHG emissions caused by the company's activities in its own business operations |
Actual | Own business activity | |||
| Contribution to global warming from the organisation's scope 3 GHG emissions that result from activities in the organisation's upstream or downstream value chain |
Actual | Upstream and downstream value chain |
||||||
| Chance | Medium to long ‐term |
Advantage over competitors in procurement due to the company's low GHG emissions (e.g. through GHG re‐ ductions in line with the 1.5°C target) |
Potential | Own business activity | ||||
| Increased financial capacity due to (better) access to fi‐ nancing or higher company valuation due to lower greenhouse gas emissions |
Potential | Own business activity | ||||||
| Low‐CO2 products and services: ‐ Low‐CO2 products and services open market opportu‐ nities |
Potential | Own business activity | ||||||
| Risk | Medium to long‐ term |
Increased purchase prices due to climate‐related transi‐ tion events, such as climate change regulations leading to higher raw material costs (considering a 1.5°C cli‐ mate scenario). |
Potential | Own business activity | ||||
| Energy | Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Energy consumption from non‐regenerative resources within the company's own activities |
Actal | Own business activity | |||
| Energy consumption from non‐regenerative resources within the company's upstream or downstream value chain |
Actual | Upstream and downstream value chain |
||||||
| Chance | Medium to long ‐term |
Saving money by becoming more energy efficient or us‐ ing less energy |
Potential | Own business activity | ||||
| Own operations and value chain: Stronger market position: Opportunity to outperform competitors through efficient energy management |
Potential | Own business activity | ||||||
| Lower financing costs: ‐ Energy performance indicators could be used in sus‐ tainable financial instruments and possibly lead to lower financing costs. ‐ Production of energy‐efficient products and services (market advantage and reputation benefits). ‐ Ratings and rankings could be improved by improving energy performance. The reduction in financing costs could be used in sustainable financial instruments based on better rating and ranking performance. |
Potential | Own business activity | ||||||
| E3 ‐ Water and marine resources | ||||||||
| Water/water con‐ sumption |
Neg. im‐ pact |
Short, me‐ dium and long ‐term |
Contribution to water scarcity due to high water with‐ drawal caused by activities within own operations |
Actual | Own business activity |
| E5 ‐ Resource utilisation and the circular economy | ||||||
|---|---|---|---|---|---|---|
| Resource inflows, including resource utilisation (blood plasma) |
Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Withdrawal and/or utilisation of renewable resources through activities within the company's own operations |
Actual | Own business activity | |
| Withdrawal and use of renewable resources through activities within the organisation's upstream or down‐ stream value chain |
Actual | Upstream value chain | ||||
| Resource inflows, including resource utilisation |
Risk | Short, me‐ dium and long‐ term |
Increased monitoring and evaluation of the value chain. Investment in additional controls and in the perfor‐ mance of due diligence studies at suppliers. |
Potential | Own business activity | |
| Resource outflows in connection with products and services |
Medium to long ‐term |
Increased costs due to the need to implement a circular product design. The transition to a circular economy re‐ quires significant upfront investments in novel technol‐ ogies to optimise and reuse recycled materials. |
Potential | Own business activity | ||
| Waste | Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Generation of non‐recyclable waste from the compa‐ ny's own activities. Manufacturing processes may gen‐ erate waste (some of which may be reused or recycled). Packaging and other waste used in or generated by pro‐ duction processes can contribute to environmental pol‐ lution if not handled properly. |
Actual | Own business activity | |
| S1 ‐ Company employees | ||||||
| Working hours | Risk | Long‐term | Vacant positions or suboptimal staffing can lead to ad‐ ditional work for employees, which could result in de‐ lays to projects, a lower rate of innovation and more in‐ efficient operations. In the pharmaceutical industry, where precise and efficient workflows are essential, such conditions can affect quality and cause additional financial burdens for Biotest. |
Potential | Own business activity | |
| Working conditi‐ ons / adequate re‐ muneration |
Risk | Long‐term | The continuing shortage of highly qualified specialists may force Biotest to offer higher salaries and additional incentives to attract and retain talented employees. This competition for skilled workers can significantly in‐ crease personnel costs. |
Potential | Own business activity | |
| Working conditi‐ ons / work‐life ba‐ lance |
Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Negative impact on the work‐life balance of employees if some employees are not allowed to plan their holi‐ days freely for operational reasons. This may also be because highly qualified employees are increasingly in short supply and a high employee turnover promotes stress for the remaining employees. |
Actual | Own business activity | |
| Working conditi‐ ons / health and safety |
Neg. im‐ pact |
Short, me‐ dium and long ‐term |
Employees have to work in an environment that affects their health and safety in terms of ‐ possible accidents at work ‐ potential risk of infection and ‐ potential work‐related deaths |
Potential | Own business activity | |
| Equal treatment and equal oppor‐ tunities for all / Gender equality and equal pay for equal work |
Chance | Short, me‐ dium and long‐ term |
Better staff retention through gender‐neutral pay, guar‐ anteed by collective agreements. |
Potential | Own business activity | |
| Neg. im‐ pact |
Staff are discouraged from pursuing training and skills development opportunities that would enhance their career development and employability, due to a busi‐ ness culture that conveys that operational business is always more important than investment in training and development programmes. This can potentially hinder the ongoing professional de‐ velopment of employees' skills and employability. |
Actual | Own business activity |
| Risk | Short, me‐ dium and long ‐term |
Lack of expertise within Biotest due to insufficiently qualified employees, resulting in lower quality products and/or services and less innovation. |
Potential | Own business activity | |
|---|---|---|---|---|---|
| Loss of workforce due to limited training budgets and opportunities |
Potential | Own business activity | |||
| Equal treatment and opportunities for all / Measures against violence and harassment at work |
Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Incidents of harassment in the workplace, which have a negative impact on the mental and physical health, job satisfaction and productivity of employees |
Potential | Own business activity |
| Chance | Short, me‐ dium and long‐ term |
Increased recruitment and retention of groups of em‐ ployees and improved overall organisational perfor‐ mance and competitiveness due to the high level of di‐ versity at Biotest, resulting in higher satisfaction levels for each group, new applicants and more innovation as different groups of people come together and bring dif‐ ferent perspectives. |
Potential | Own business activity | |
| Other work‐rela‐ ted rights / pri‐ vacy |
Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Potential negative impact on employees' personal data due to breaches of data protection policies or security breaches in IT systems. |
Potential | Own business activity |
| Risk | Fines, penalties, sanctions or costs of remedial action for violations of workers' privacy rights. |
Potential | Own business activity | ||
| S4 ‐ Consumers and end users | |||||
| Information‐re‐ lated effects for consumers and/or end users / data protection |
Neg. im‐ pact |
Short, me‐ dium and long ‐term |
A serious data protection breach resulting in the loss or theft of special categories of personal data (cus‐ tomer/patient information) could have a negative im‐ pact on those affected. This could permanently damage the trust of customers/patients. |
Potential | Downstream value chain |
| Information‐re‐ lated impact on consumers and/or end‐users / free‐ dom of expression |
Neg. im‐ pact |
Short, me‐ dium and long ‐term |
Consumers and end users are unable to express their concerns regarding Biotest's products and/or services, which increases product dissatisfaction and could affect the effectiveness of the medication. |
Potential | Downstream value chain |
| Information‐re‐ lated effects for consumers and/or end users / access to (high‐quality) information |
Neg. im‐ pact |
Short, me‐ dium and long ‐term |
Negative impact on customers' and/or end users' ac‐ cess to (quality) information, as not all relevant infor‐ mation about the products and/or services is made available on the Biotest website, in the operating in‐ structions or in other media instruments intended to in‐ form consumers and/or end users about Biotest's prod‐ ucts and/or services. |
Potential | Downstream value chain |
| Personal safety of consumers and/or end‐users / health |
Pos. im‐ pact |
Short, me‐ dium and long‐ term |
Increasing life expectancy by developing new products that can help cure illnesses. |
Potential | Downstream value chain |
| and safety | Neg. im‐ pact |
Inadequate practices and non‐compliance, both in Bi‐ otest's direct operations and throughout the supply chain, can seriously compromise the quality of treat‐ ments and ultimately endanger the health of patients. In Biotest's manufacturing facilities, strict adherence to hygiene and safety standards is essential to avoid prod‐ uct contamination. Disease can increase the risk of cross‐contamination, which can affect the safety and efficacy of the drugs produced. This also applies to the risk of treating patients with counterfeit drugs and the spread of disease due to in‐ adequate donor control, which ultimately endangers public health. ' |
Potential | Downstream value chain |
|
| Personal safety of consumers and/or end‐users / Personal security |
Neg. im‐ pact |
Short, me‐ dium and long‐ term |
A lack of focus on the monitoring and administration of clinical studies can have a negative impact on patient safety. |
Potential | Downstream value chain |
| Social inclusion of consumers and/or end‐users/non‐ |
Neg. im‐ pact |
Medium ‐ term |
'Increased demands and stricter regulations in certain sales markets can lead to a shortage of medicines. This, as well as an increase in the price of medicines due to monopolistic practices and problematic access, could particularly affect developing countries.' |
Potential | Own business activity |
| discrimination, ac‐ cess to products |
|||||
|---|---|---|---|---|---|
| and services | Pos. im‐ pact |
Short‐ term | Promoting access to medical treatment by participating in accessibility programmes. |
Potential | Own business activity |
| Chance | Short ‐term | Developing new market segments and increasing de‐ mand by offering products and/or services to customer groups that are not, or not sufficiently, addressed by competitors. |
Potential | Own business activity | |
| Social inclusion of consumers and/or end users/respon‐ sible marketing practices |
Chance | Short, me‐ dium and long ‐term |
Responsible business practices and a transparent policy that contributes to consumer trust, knowledge and safety. |
Potential | Own business activity |
| G1 ‐ Corporate policy | |||||
| Corporate culture | Neg. im‐ pact |
Short ‐term | A corporate culture that does not consider welcoming everyone regardless of their appearance, beliefs, back‐ ground, gender and language has a negative impact on employees in that their identity is undermined or weak‐ ened. |
Potential | Own business activity |
| A corporate culture that encourages misconduct by managers has a negative impact on the well‐being of employees. |
Potential | Own business activity | |||
| Potential for scandal by contributing to the establish‐ ment of a plasma donation market and perceived eco‐ nomic dependence on vulnerable groups dependent on donations. |
Potential | Own business activity | |||
| Potential for scandal resulting from the contribution to the establishment of a plasma donation market and a dependency of patients who rely on donations. |
Potential | Own business activity | |||
| Medium ‐ term |
A corporate culture that does not place high ESG de‐ mands on business partners has a negative impact on employees along the value chain and on the environ‐ ment. This can manifest itself in low employee satisfac‐ tion, failure to reduce emissions and waste, inefficient use of resources, and failure to promote biodiversity and protect natural habitats. |
Potential | Upstream and downstream value chain |
||
| A weak corporate culture can have a detrimental effect on society and the environment. It can encourage cor‐ ruption, bribery and anti‐competitive behaviour, which can in turn inhibit economic development, damage public trust in the economy, promote social inequality, and lead to the destruction of habitats, pollution of air and water, and the loss of biodiversity. |
Potential | Own business activity | |||
| Risk | Medium ‐ term |
Low employee motivation and retention, as well as loss of employees and/or reduced recruitment due to the lack of a positively perceived corporate culture. |
Potential | Own business activity | |
| Failure to live up to public expectations can damage a company's reputation. This can have a negative impact on the confidence of business partners, investors, cus‐ tomers and other stakeholders. |
Potential | Own business activity | |||
| A corporate culture perceived as negative by society can lead to a shortage of donors and plasma. |
Potential | Own business activity | |||
| Management of relations with suppliers, includ‐ ing payment prac‐ tices |
Risk | Medium ‐ term |
Stricter regulations and new rules for sustainable sup‐ ply chains, bringing new investments and total cost of ownership. |
Potential | Own business activity |
| Protection of whistleblowers |
Neg. im‐ pact |
Short and medium ‐ term |
Inadequate protection against retaliation can lead to many negative consequences for the whistleblower. These include negative career development, social iso‐ lation, psychological stress and financial loss. Ineffective communication channels and a lack of ano‐ nymity in reporting incidents undermine the confi‐ dence, well‐being and mental health of whistleblowers. |
Potential | Own business activity |
| Chance | Medium‐ term |
Detecting and preventing illegal activities within the company. Damage can be minimised by responding quickly to reported incidents. |
Potential | Own business activity |
| Corruption & brib‐ ery / prevention and detection, in‐ cluding training |
'Bribes can inflate the price of medicines and reduce ac‐ cess to healthcare for those who cannot afford it. Bribing officials can result in unsafe or ineffective medi‐ cines being approved, thereby endangering public health.' |
Potential | Own business activity | ||
|---|---|---|---|---|---|
| Risk | Short ‐term | Cases of corruption or bribery in the value chain can lead to unforeseen interruptions in the supply chain and thus to associated financial losses. |
Potential | Own business activity | |
| Chance | Medium‐ term |
Avoiding potential costs by establishing an effective risk management and compliance culture that helps to pre‐ vent corruption and bribery within your own organisa‐ tion. |
Potential | Own business activity | |
| Corruption & bribery / incidents |
Neg. im‐ pact |
Short‐ term | Contribute to a negative sense of well‐being among employees if a transparent, fair and proactive process for handling incidents is not implemented within the or‐ ganisation. |
Potential | Own business activity |
| Cybersecurity | |||||
| Neg. im‐ pact |
Short‐ term | IT systems can be the target of effective cyber‐attacks. The loss and possible misuse of personal data has many consequences for the individual concerned. These may include the loss of privacy combined with psychological distress, damage to reputation, the risk of identity theft, or legal and administrative challenges. |
Potential | Own business activity | |
| Cyber‐attacks can cause IT systems to fail, meaning that Biotest is temporarily unable to operate in certain ar‐ eas. The disruption to operations (e.g. plasma procure‐ ment, plasma donation, shipping) may have a negative impact on patients. |
Potential | Own business activity | |||
| Risk | Short, me‐ dium and long ‐term |
Fines, penalties, sanctions or costs of remediation for breach of employee privacy rights due to lack of ade‐ quate cybersecurity profile. |
Potential | Own business activity | |
| Cyber attacks can cause IT systems to fail, meaning that Biotest is temporarily unable to operate certain areas. The operational downtime (e.g. plasma purchases, plasma donations, shipping) can lead to a loss of reve‐ nue and/or reputational damage at Biotest. |
Potential | Own business activity | |||
| Plasma donors | |||||
| Health and safety | Neg. im‐ pact |
Short, me‐ dium and long ‐term |
Deaths caused by the business activities of companies in the value chain, e.g. plasma collection. |
Potential | Upstream value chain |
| Negative effects due to possible risk of infection for plasma donors. Long‐term health problems can impair the quality of life of donors and lead to lasting negative effects. In the worst case, deaths could occur that are caused by the business activity. |
Potential | Upstream value chain | |||
| Data protection | Neg. im‐ pact |
Short, me‐ dium and long‐ term |
Ein schwerwiegender Datenschutzverstoß, der zum Verlust oder Diebstahl sensibler Spenderinformationen führt, könnte die betroffenen Spender negativ beein‐ flussen. Dies könnte das Vertrauen der Spender dauer‐ haft beschädigen und die Anzahl der freiwilligen Spen‐ der reduzieren. |
Potential | Upstream value chain |
| The following overview shows the material topics, risks, opportunities and impacts in accordance with the requirements of the ESRS, which were followed when preparing the sustainability declaration. |
|||
|---|---|---|---|
| ESRS Standard |
DR | Description | Page |
| ESRS 2 | BP‐1 | General information for the preparation of the sustainability report declaration | 48 |
| BP‐2 | Information related to specific circumstances | 48, 49 | |
| GOV‐1 | The role of the Board of Management the Supervisory Board | 49, 50 | |
| GOV‐2 | Information and sustainability aspects addressed by the Board of Management and the Supervisory Board | 51, 52 | |
| GOV‐3 | Inclusion of sustainability performance in incentive systems | 53 | |
| GOV‐4 | Statement on due diligence | 53, 54 | |
| GOV‐5 | Risk management and internal controls in sustainability reporting | 54 | |
| SBM‐1 | Strategy, business model and value chain | 55, 56 | |
| SBM‐2 | Stakeholder interests and perspectives | 57 | |
| SBM‐3 | Material impacts, risks and opportunities and how they relate to the strategy and business model | 58 | |
| IRO‐1 | Description of the process for identifying and assessing material impacts, risks and opportunities | 62 | |
| IRO‐2 | Disclosure requirements included in ESRS covered by the organisation's sustainability statement | 74 | |
| GOV‐3 | Inclusion of sustainability‐related performance in incentive systems | 77 | |
| E1 | E1‐1 | Transition plan for climate protection | 79 |
| SBM‐3 | Significant impacts, risks and opportunities and their interaction with strategy and business model | 79 | |
| IRO‐1 | Description of the processes for identifying and assessing significant climate‐related impacts, risks and opportuni‐ ties |
78 | |
| E1‐2 | Concepts related to climate protection and adaptation to climate change | 79 | |
| E1‐3 | Measures and means in connection with the climate concepts | 80, 81 | |
| E1‐4 | Targets related to climate change mitigation and adaptation | 80 | |
| E1‐5 | Energy consumption and energy mix | 82 | |
| E1‐6 | Scope 1, 2, 3 and total GHG emissions | 83 | |
| E1‐7 | GHG removals and GHG reduction projects financed through carbon credits | 85, 86 | |
| E1‐8 | Internal carbon pricing | 86 | |
| IRO‐1 | Description of the procedures for identifying and assessing the principal impacts, risks and opportunities associ‐ ated with water and marine resources |
87 | |
| E3‐1 | Concepts associated with water and marine resources | 87 | |
| E3 | E3‐2 | Measures and means associated with water and marine resources | 87 |
| E3‐3 | Targets associated with water and marine resources | 88 | |
| E3‐4 | Water consumption and reuse | 88, 89 | |
| IRO‐1 | Description of processes for identifying and assessing significant impacts, risks and opportunities associated with resource use and circular economy |
90 | |
| E5‐1 | Concepts related to resource use and circular economy | 89 | |
| E5 | E5‐2 | Measures and means related to resource use and circular economy |
90, 91 |
| E5‐3 | Targets related to resource use and circular economy | 91 | |
| E5‐4 | Resource inflows | 91 |
| E5‐5 | Resource outflows | 91, 92 | |
|---|---|---|---|
| SBM‐2 | Interests and perspectives of stakeholders | 117 | |
| SBM‐3 | Material impacts, risks and opportunities and their interaction with the strategy and business model | 103 | |
| S1‐1 | Concepts related to the organisation's workforce | 102 | |
| S1‐2 | Procedures for involving the organisation's workers and their representatives in relation to impacts | 112 | |
| S1‐3 | Procedures for improving negative impacts and channels for the organisation's workers to provide feedback and voice concerns |
110 | |
| S1‐4 | Actions taken in relation to significant impacts on the organisation's workers and approaches to managing signifi‐ cant risks and opportunities related to the organisation's workers; and the effectiveness of those actions |
107 | |
| S1‐5 | Targets related to addressing significant negative impacts, promoting positive impacts and managing significant risks and opportunities |
107 | |
| S1‐6 | Characteristics of the company's employees | 105, 106 | |
| S1 | S1‐7 | Characteristics of the company's external workforce | 105,106 |
| S1‐8 | Collective bargaining coverage and social dialogue | 105, 106 | |
| S1‐9 | Diversity indicators | 106, 107 | |
| S1‐10 | Decent remuneration | 107, 108 | |
| S1‐11 | Social security | 107, 108 | |
| S1‐13 | Key figures for training and skills development | 108 | |
| S1‐14 | Key figures for health and safety | 108 | |
| S1‐15 | Remuneration indicators (pay gap and total remuneration) | 108 | |
| S1‐16 | Remuneration/pay gap and total assets | 108 | |
| S1‐17 | Incidents, complaints and serious impacts related to human rights | 110 | |
| SBM‐2 | Stakeholder interests and perspectives | 117 | |
| SBM‐3 | Material impacts, risks, and opportunities, and how they interact with the strategy and business model | 121 | |
| S4‐1 | Concepts related to consumers and end users | 117 | |
| S4‐2 | Procedures for consumer and end‐user involvement in relation to impacts | 118 | |
| S4 | S4‐3 | Processes for improving negative impacts and channels for consumers and end users to provide concerns | 119 |
| S4‐4 | Measures taken to address material impacts on consumers and end‐users and approaches to managing material risks and opportunities related to consumers and end‐users, and the effectiveness of these measures |
119 | |
| S4‐5 | Targets related to addressing material negative impacts, driving positive impacts, and managing material risks and opportunities. |
120 | |
| G1 | GOV‐1 | The role of the Board of Management and the Supervisory Board | 122 |
| IRO‐1 | Description of the procedures for identifying and assessing the principal impacts, risks and opportunities | 124 | |
| G1‐1 | Corporate culture and concepts for corporate governance | 123, 124 | |
| G1‐2 | Management of relationships with suppliers | 128 | |
| G1‐3 | Prevention and detection of corruption and bribery | 127 | |
| G1‐4 | Cases of corruption or bribery | 127 | |
| G1‐6 | Payment practices | 128 | |
| Entitiy‐ specific |
Donors | 114 |
| Cybersecurity | 128, 129 | |
|---|---|---|
F.II. ENVIRONMETAL INFORMATION
F.II.1 E1 CLIMATE CHANGE
Climate change and business strategy
Biotest AG's sustainability strategy sets a clear target of reducing CO₂ emissions (Scope 1 and Scope 2) by 90 % by 2045 compared to the base year 2023. This commitment emphasises the company's strategic focus on climate protection, underscoring its commitment to sustainable business practices.The strategic emphasis on renewable energies, processinnovations and efficient resource utilisation high‐ lights the company's recognition of the interconnected relationship between climate change and corporate responsibility. To this end, reporting for the 2024 reporting year will also be carried out on a new systematic basis, underlining our ongoing commitment to reducing emissions, saving resources and establishing more efficient production.
As a manufacturing company with energy‐intensive production, Biotest AG recognisesitsspecial responsibility as part of itssustainability strategy, particularly with regard to climate change. Accordingly, the sustainability strategy includes a comprehensive risk analysis and the development of robust adaptation strategiesto minimise the company'simpact on the environment, as well asthe impact of climate change on the business model. By integrating climate protection into the entire value chain, the company aims to enhance its resilience to climate change and make a positive contribution to the environment and society.
At Biotest AG, we recognise the pivotal role that climate change plays in our business landscape. It is a central component of our sus‐ tainability strategy, and we have implemented comprehensive procedures to identify and assess climate‐related physical and transition risks. Scenario analyses provide a vital foundation for making informed assessments of the short‐, medium‐ and long‐term impacts on our business model. Climate change is closely linked to the other ESRS standards E3‐Water and marine resources and E5‐Resource use and circularity, as the issues are closely related. The different strategies are interlinked and mutually reinforcing, so that, for example, progress on decarbonisation has an indirect, and in some cases significant, impact on the other standards.
Inclusion of sustainability‐related performance in incentive systems (GOV‐3)
Biotest AG has implemented incentives to promote sustainability‐related performance, including climate‐related performance:
The incentive systems for members of the Management Board include clear targets for improving energy efficiency. Performance is evaluated on the basis of specific sustainability‐related targets, such as reducing Scope 1 and Scope 2 emissions. Sustainability‐related performance parameters are an integral part of the remuneration policy and are reviewed annually.
The incentive system for the members of the Executive Board includes both financial and non‐financial criteria. The importance of sus‐ tainability targets is reflected in the long‐term variable remuneration of the members of the Executive Board. On average, 7.5 % of the achievement of the long‐term targets is allocated to the achievement of sustainability targets. These targets are set and regularly re‐ viewed by the Supervisory Board to ensure that they are aligned with the strategic priorities of the company.
Material impacts, risks and opportunities and their interaction with the strategy and business model (SBM‐3)
As part of its materiality analysis for 2024, Biotest AG has analysed the impacts, opportunities and risks of its own business activities in relation to climate change. Assets and business activities along the entire value chain were examined for actual and potential impacts, risks and opportunities.
The following negative impacts of business activities on climate change were identified:
- Greenhouse gas emissions from business activities (Scope 1 & 2): Biotest AG causes direct (Scope 1) and indirect (Scope 2) greenhouse gas emissions through production, transport and building operation. These emissions contribute to global warm‐ ing and represent a key challenge for the company's climate strategy.
- Greenhouse gas emissions along the value chain (Scope 3): Activities in the upstream and downstream value chain, such as raw material sourcing, logistics or distribution, also lead to carbon emissions. These indirect emissions require targeted re‐ duction measures and close collaboration with suppliers.
- Energy consumption from non‐renewable resources: In its own operations, Biotest AG uses fossil fuels for heating, cooling and the vehicle fleet, which are included in Scopes 1 and 2.
- Energy consumption in the supply chain: External production processes, transport vehicles and the cooling of blood plasma in the value chain are also partly based on fossil fuels. These are included in scope 3. The associated emissions are outside the direct control of Biotest AG, but represent an important area of action for the climate strategy.
Climate change also presents risks and opportunities for the Biotest Group. The following risks were identified in the dual materiality analysis:
Physical risks
- Climate change can lead to higher operating costs due to rising temperatures and more frequent extreme weather events.
- In particular, the increased need for refrigeration to store blood plasma requires additional investment in energy‐efficient refrigeration systems.
- Weather‐related infrastructure disruptions can lead to production stoppages and supply chain disruptions.
Transitional risks
- More stringent regulatory requirements, particularly in relation to the EU taxonomy and sustainability reporting, can lead to higher investment and conversion costs.
- Carbon pricing and rising energy and raw material costs (e.g. for gas, fuel and packaging materials) increase economic pres‐ sures.
- Market demands for sustainable production are increasing, requiring adjustments throughout the value chain.
Despite the challenges, climate change and the transition to a climate‐neutral economy also present strategic opportunities for Biotest AG:
- Competitive advantages in tenders: Sustainability criteria are becoming increasingly important in public and private procure‐ ment. Companies with a strong climate strategy and low greenhouse gas emissions have a better chance of success.
- Better access to financing and higher company valuation: Investors and financial institutions are increasingly favouring com‐ panies with clear decarbonisation strategies. Good ESG performance can improve access to finance and enhance company valuation.
- Expanding product portfolios to include low‐carbon solutions: Customers are increasingly demanding climate‐friendly prod‐ ucts. Developing and marketing low‐carbon alternatives strengthens a company's competitive position and opens up new market opportunities.
Saving money through energy efficiency:
- Efficiency gains in production processes help to mitigate rising energy prices and achieve long‐term savings.
- Measuressuch as heat recovery, optimisation of cooling processes and the use of low‐emission technologiesreduce operating costs.
- Optimised energy management strengthens market position: Companies that manage their energy consumption efficiently and reduce emissions improve their competitiveness while meeting regulatory requirements.
Lower financing costs through ESG optimisation: Sustainability indicators can be specifically incorporated into financing in‐ struments, potentially enabling more favourable lending terms. Improved ratings and rankings through improved energy ef‐ ficiency and reduced emissions can reduce the cost of capital
Description of processes for identifying and assessing significant climate‐related impacts, risks and opportunities (IRO‐1)
Results of resilience and scenario analysis to assess transition and physical risks
Following the dual materiality analysis, which also took into account the climate scenario analysis conducted earlier, a group‐wide resil‐ ience analysis was conducted, focusing on the Dreieich production site, to assess the company's resilience to the identified climate risks. The methodology and implementation of the resilience analysis is described in detail in ESRS 2.
Climate scenario analysis
Biotest AG has conducted a comprehensive analysis of climate scenarios to assess the impact of climate change on its business model. The physical risks and strategic opportunities under different climate scenarios were examined. The analysis includes an assessment of the financial impact and the company's resilience to climate‐related changes. It also looked at the company's own operations at the Dreieich production site and at the company's other sites.
Process for identifying and assessing climate‐related impacts
Biotest uses scientifically based climate scenarios to assess climate risks. Short‐, medium‐ and long‐term time horizons are considered. The scenario analyses are based on IPCC models and include various emission trends in order to comprehensively capture potential risks and opportunities. The impact of climate change on our business is regularly reviewed. Financial, operational and reputational impacts are analysed and integrated into our strategic planning.
The analysis of physical climate‐related risks was based on location‐specific geographic coordinates and considered both physical risks such as extreme weather events, water scarcity and power outages, which could particularly affect production processes and plasma cooling, and transition risks, including rising carbon pricing, regulatory requirements and changing market demands. The criteria were defined based on double materiality, the geographical location of the company's sites, and financial impacts on operating costs and adaptation measures. This should ensure that Biotest systematically assesses all relevant climate risks and can develop appropriate adaptation measures. Important drivers in the analysis for Biotest were the energy‐intensive production and the dependence on fossil fuels, as well as the increasingly severe effects of climate change (increased drought).
Climate Risk Analysis and Scenarios
Biotest conducted a site‐specific climate risk analysis for 47 company sites to assess the exposure to 19 climate‐related hazards. The following scenarios have been analysed
- RCP 2.6: high emissions reduction scenario (<2°C warming)
- RCP 4.5 & RCP 6.0: stabilisation scenarios with moderate or delayed emissions reductions
- RCP 8.5: worst‐case scenario (>4°C warming)
The analysis was carried out for different time horizons:
- Short term (up to 5 years)
- Medium term (up to 10 years)
- Long‐term (up to 30 years)
The results show that ten sites are significantly affected by climate risks, particularly under the RCP 6.0 and RCP 8.5 scenarios, where heat waves and water stress are particularly pronounced. This can lead to business disruption and increased operating costs.
Financial implications of climate scenarios for the company
The financial assessment of climate risks and the calculation of the investments required to achieve the efficiency and carbon reduction targets are currently being prepared. Uncertainties and strategic adjustments will be taken into account, including:
- The impact of regulatory developments on production costs
- Necessary technological adjustments
- Long‐term energy price trends
At the same time, opportunities arising from adaptation to the climate scenarios developed will be considered, including
- Reducing energy consumption in production
- Savings from the use of renewable energy
- Developing new market opportunities through sustainable products
Results: Resilience of strategy and business model to climate change
Biotest AG's climate scenario and resilience analyses show that climate change poses both physical and transition risks to the business model. At the same time, opportunities arise from decarbonisation and efficiency improvements.
The physical risks and their impact on the business model primarily affect the production site in Dreieich, Germany. Extreme weather events, such as heat waves, storms and floods, and the resulting power outages could have a significant impact on critical processes and assets. The main risks are increased energy consumption for plasma storage, particularly to ensure stable refrigeration chains, the vul‐ nerability of infrastructure and supply chains to extreme weather conditions, and the disruption of critical production processes, partic‐ ularly plasma cooling, which is highly dependent on a stable power supply.
In the short‐term, rising operating costs due to carbon pricing and regulatory adjustments were identified as transition risks and eco‐ nomic impacts. Similarly, investments in low‐emission technologies and energy efficiency measures were identified as medium‐term transition risks. Long‐term financial risks are associated with the transition to carbon‐neutral production processes and sustainable prod‐ ucts.
The analysis shows that Biotest AG's business model is highly resilient. Detailed results of the resilience analysis can be found in this Sustainability Statement in the section ESRS 2 ‐ Major IROs and their connection to the value chain (SBM‐3) – Resilience analysis.
Concepts related to climate change mitigation and adaptation (E1‐2)
Biotest AG pursues a climate strategy to meet the challenges of climate change while at the same time opening up opportunities for sustainable, climate‐neutral corporate development. Through targeted measures for energy efficiency, decarbonisation and the use of renewable energies, the significant climate‐related impacts, risks and opportunities (IROs) are addressed and integrated into strategic planning.
Strategies, concepts and transition plan
Biotest AG views climate change as a strategic challenge and integrates targeted measures for energy efficiency, decarbonisation and the use of renewable energies into its corporate strategy. In order to ensure the long‐term resilience of its business model, Biotest systematically addresses climate‐related risks and opportunities (IROs), guided by science‐based targets, regulatory requirements and market‐driven developments. The company's long‐term climate strategy is in line with the requirements of the Paris Agreement and aims to reduce CO₂ emissions by 90% by 2045. Biotest AG is not exempt from the EU reference values agreed in Paris. This goal is being pursued through energy‐efficient production methods, renewable energies and investments in innovative technologies, with progress being regularly reviewed and adapted to new regulatory frameworks. The Portfolio Committee on Sustainability presents the recom‐ mendations from the Transformation Plan and other sustainability‐related concepts to the Board of Management for integration into strategic planning.
Targets related to climate change mitigation and adaptation (E1‐4)
Short‐, medium‐ and long‐term climate targets:
- Short‐term (until 2025): 2 % reduction in Scope 1 and 2 emissions per year starting from the baseline year 2023.
- Medium‐term (until 2035): 20 % reduction in CO₂ emissions compared to the baseline year 2023.
- Long‐term (until 2045): 90 % reduction of Scope 1 and Scope 2 emissions to achieve the goal of climate neutrality.
With regard to Scope 3 emissions, the targets will be developed in the next few years as soon as the database has been further devel‐ oped. The Transitionsplan of Biotest AG combines various relevant concepts approved by the Board of Management (such as the trans‐ formation concept, strategy concepts for corporate sustainability, etc.) in the company, which serve to implement the group‐wide sus‐ tainability strategy. The individual measures of the transition plan regarding climate change adaptation are described below. The targets were calculated based on the assumption of EU climate neutrality by 2050 based on the previous emissions from production.
Corporate governance
Biotest has established a governance structure to effectively manage climate‐related measures:
- Responsibilities: The Management Board monitorsthe implementation of the climate strategy and isregularly informed about progress. The Management Board is part of the Sustainability Review Board, which meets 3‐4 times a year.
- Portfolio Committee Sustainability: A cross‐functional committee coordinates all climate‐related activities and ensures that climate issues are integrated into the company's decision‐making process. Number of meetings per year: 4.
- Integration of climate risks: Some business units already consider climate risks and sustainability issues in their decision‐mak‐ ing processes.
- Climate change transition plan: The phased decarbonisation plan is based on the 1.5°C target of the Paris Agreement and includes detailed measures to reduce carbon emissions and integrate renewables.
Senior management is directly involved in steering the climate strategy:
- Regular board meetings: Topics related to the company's adaptation to climate change are regularly included in board meet‐ ings to discuss investments and strategic adjustments.
- Consideration of climate‐related risks and opportunities: Climate impacts are integrated into business strategy to address financial, operational and regulatory challenges at an early stage.
The specific investments and financing for the measures in the transition plan have not yet been determined at the time of reporting. The current investment rate (CapEx) for climate‐related measures according to the EU Taxonomy Regulation is 3.56 %.
Measures and strategies in the context of climate protection and adaptation to climate change (E1‐3)
To counter climate‐related risks and adapt its business activities to climate change, Biotest has implemented a multi‐level climate strat‐ egy. This includes measures in the areas of energy efficiency and decarbonisation.
All of the measures described below relate to all of the IROs (key impacts, risks and opportunities) in E1. The measures affect the entire value chain to varying degrees, with many activities focused on the Dreieich production site.
Decarbonisation and emissions reduction measures
Existing measures:
- Energy efficiency: Implementation of modern combined heat and power plants (CHP), innovative heat recovery technologies and heat pumps to reduce specific energy consumption in production.
- Decarbonisation: Use of renewable energies to significantly reduce CO₂ emissions.
- Renewable energies: Operation of photovoltaic capacities to ensure the long‐term supply of renewable energies.
Planned measures:
- Expansion of our own energy production through additional photovoltaic systems and the expansion of access to renewable energies through various models (Powe Purchase Agreement (PPA), self‐construction, municipal partnerships, etc.).
- Electrification of gas‐powered systems by 2045 to achieve a high degree of climate neutrality.
- Development of a local heating network for the efficient use of waste heat from production processes.
- Decarbonisation of the supply chain: development of a Scope 3 reduction plan by 2026 with a focus on sustainable transport solutions and climate‐friendly raw material procurement.
Measures by time horizon
Short‐term actions (until 2025)
- Increase resilience of production facilities through climate‐friendly cooling technologies.
- Optimise electricity use to offset increasing cooling demand.
- Collect granular Scope 1‐3 data to identify further efficiency potential.
Medium‐term actions (until 2035)
- Invest in sustainable infrastructure such as energy efficient buildings and advanced cooling methods
- Diversify supply chains to reduce regional dependence
- Expand renewable energy sources, e.g. by increasing the use of photovoltaic systems
Long‐term actions (until 2045)
- Climate‐neutral production processes through electrification, sustainable technologies and offsetting of remaining emis‐ sions.
- Integrate climate risks into site planning to ensure sustainable energy supply.
- Continue to develop climate‐friendly alternatives in production and logistics.
Progress and monitoring of decarbonisation and emissions reduction
Biotest regularly measures and reviews progress in decarbonisation. To this end, key performance indicators (KPIs) for energy and emissions reduction have been recorded and published annually in the sustainability reports:
- Total energy consumption (MWh) to evaluate energy efficiency measures.
- Greenhouse gas emissions (tCO₂eq) according to Scope 1, 2 and 3 for quantitative assessment of emission reductions.
- Proportion of renewable energy (%) to document progress in switching to climate‐friendly energy sources.
- Energy consumption per unit of production (kWh/litre of plasma) to determine efficiency gains.
To ensure continuous improvement, Biotest AG regularly reviews the effectiveness of the measures and adapts its strategy to new scientific findings and regulatory requirements.
KPIs for supply chain diversification and the development of climate‐friendly alternatives in production and logistics are currently being developed (definition of implementation steps, type of progress measurement, etc.) and will be published in subsequent reporting years. Further involvement of other stakeholders is planned for future reporting years.
Biotest uses a reporting system to monitor and control its sustainability strategy. Quarterly internal status updates are provided to management and reviews are carried out by the Sustainability Review Board and the Portfolio Committee Sustainabilityto analyse trends and adjust measures.
Key figures
Energy consumption and energy mix (E1‐5)
The efficient and sustainable use of energy is the cornerstone of Biotest AG's climate protection strategy. As a pharmaceutical company, we have a focus on reducing greenhouse gas emissions (GHG), optimising our energy consumption and gradually integrating renewable energies into our operations.
Total energy consumption and sources
In the reporting year 2024 , the total energy consumption of Biotest AG was 114,566,700 kWh. This figure includes all energy sources used. This includes both fossil and renewable energy sources.
Renewable energies: Through the continuous expansion of our photovoltaic system, we increased the share of renewable energies in our energy mix. In 2024, Biotest generated a total of 266,092 kWh from renewable and 5,637,840 kWh non‐renewable sources.
Table I: Energy consumption and mix38
| Energy consumption and energy mix in kWh | 2024 | 2023 |
|---|---|---|
| (1) Fuel consumption from coal and coal products | – | – |
| (2) Fuel consumption from crude oil and petroleum products | 1,096,096.9 | 1,193,747.0 |
| (3) Fuel consumption from natural gas | 77,242,476.0 | 81,470,962.0 |
| (4) Fuel consumption from other fossil sources | – | ‐ |
| (5) Consumption from purchased or received electricity, heat, steam and cooling and from fossil sources |
35,929,277.0 | 34,518,837.0 |
| (6) Total consumption of fossil energy | 114,267,849.9 | 117,183,546.0 |
| Share of fossil sources in total energy consumption (in %) | 99.7 | 99.9 |
| (7) Consumption from nuclear power sources | – | ‐ |
| Share of consumption from nuclear sources in total energy consumption (in %) |
– | ‐ |
| (8) Fuel consumption for renewable sources, including biomass (including industrial and municipal waste of biological origin, biogas, hydrogen from renewable sources, etc.) |
– | ‐ |
| (9) Consumption from purchased or received electricity, heat, steam and cooling and from renewable sources |
32,758.0 | 37,432.0 |
| (10) Consumption of self‐generated renewable energy other than fuels | 266,092.0 | 41,438.0 |
| (11) Total consumption of renewable energy | 298,850.0 | 78,870.0 |
| Share of renewable sources in total energy consumption (in %) | 0.3 | 0.1 |
| Total energy consumption | 114,566,699.9 | 117,262,416.0 |
Energy efficiency and energy intensity
Biotest AG is consistently pursuing the measures described above to increase energy efficiency. At the production site in Dreieich, we were able to reduce the specific energy consumption per litre of processed plasma from 66.3 kWh/l (2022) to 62.7 kWh/l (2023). This represents a reduction of 5.4% in one year. The almost unchanged energy consumption per litre of processed plasma in 2024 (65.0 kWh/l) despite increasing production demonstrates Biotest AG's ongoing commitment to the efficient use of resources. Biotest operates in the manufacturing industry, which is considered to have a high impact on the climate. The production of drugs from human blood plasma requires energy‐intensive processes, particularly in the areas of refrigeration and clean room technology. In addition, there is a high dependency on supply chains that also involve energy‐intensive transport processes. To determine the energy intensity, the total energy used in the production processes and the specific energy intensity of the relevant activities in the pharmaceutical industry were determined, as well as industry‐specific benchmarks.
Energy intensity:
Table II: Energy intensity based on net income

The underlying net revenue relates to the group revenue from activities in climate‐intensive sectors.
Financial resources and investments
For the implementation of measures to improve the energy mix and increase energy efficiency, €2,992,265 in OpEx was spent in 2024 on measures to reduce total energy consumption. Additionally, €443,953 was invested (CapEx) in measures to reduce total energy con‐ sumption.
Greenhouse gas emissions (E1‐6)
Biotest AG pursues a climate strategy to reduce its greenhouse gas emissions (GHG) and to decarbonise its business activities. This includes measures for energy efficiency, the expansion of renewable energies and targeted process optimisation along the value chain. The basis for reducing emissions is the accounting of Scope 1‐3 emissions along the entire value chain. The Biotest Group accounts for its Scope 1, Scope 2 and Scope 3 GHG emissions in accordance with the Greenhouse Gas Protocol in the following categories:
- Scope 1: Direct emissions from the combustion of fossil fuels in production plants, buildings and company vehicles.
- Scope 2: Indirect emissions from energy procurement (e.g. electricity, district heating) resulting from the use of non‐regener‐ ative energy sources.
- Scope 3: Indirect emissions from the upstream and downstream value chain, including transport, supplier activities, use of sold products and disposal.
The following Scope 3 categories were included in the calculation:
| Category 1: Purchased goods and services | Category 2: Capital goods |
|---|---|
| Category 3: Fuell‐ and energy‐related activities | Category 4: Upstream transport and distribution |
| Category 5: Waste generated by operations | Category 6: Business travel |
| Category 7: Employee commuting | Category 8: Upstream leased assets |
| Category 12: Treatment of sold products at the end of their | Category 15: Investments |
| service life. |
Excluded emission categories at Biotest
Biotest has excluded certain emission categoriesfrom the calculation because they are either notrelevant or already included elsewhere:
- Category 9 (downstream transport and distribution): Emissions from outgoing transport from Biotestsitesto direct customers have already been included in category 4 (Upstream Transport & Distribution). Category 9 would only include emissions be‐ tween direct customers and end users and has therefore been excluded.
- Category 10 (Processing of products sold): Although some intermediate products are further processed, this category has been excluded as it is only relevant for a small proportion of products sold. In addition, ~80% of these intermediate products were sold to Grifols in 2024, whose emissions are already included in Scope 1 and 2 to avoid double counting.
- Category 11 (Use of productssold): Biotest does notsell any products with direct energy consumption. Energy is only required indirectly through medical devices, which is why this category is optional under the GHGP and has been excluded.
- Category 13 (Downstream leased assets): As Biotest does not lease any assets, this category is not relevant for the company.
Category 14 (franchises): Category 14 was excluded because Biotest does not operate a franchise model, so this category is not relevant.
Information on the calculation method and emission factors
Biotest calculates its greenhouse gas (GHG) emissions in accordance with the Greenhouse Gas Protocol. The calculation covers the fol‐ lowing emissions: CO2, HFCs and refrigerants, with Scope 1 and 2 accounting for 90% of CO2 emissions.
Methodology and data sources
- Scope 1: Directly measured consumption (e.g. gas consumption).
- Scope 2: Calculated using location‐based factors (local energy mix) and market‐based factors (supplier electricity mix, renew‐ able energy purchases).
- Scope 3: Hybrid approach using primary and secondary data from upstream and downstream activities and LCA methodology.
Emission factors and validation
Scope 3 emissions have been calculated in detail using the following methods
Category 1 Purchased goods and services: Biotest AG's emissions calculation is based on purchasing data and estimated expenses for plasma collection centres. The expenses were divided into direct/indirect procurement and materials/services and assigned to specific CEDA emission factorsfor 97 % of the expenses. Non‐relevant categories were excluded or calculated separately. Expenditure for plasma collection centres was extrapolated and also calculated using CEDA factors.
Category 2 Capital goods: Sub‐concepts were mapped to their corresponding CEDA emission. Emissions were calculated by multiplying the expenditures by these factors.
Category 3 Fuel‐and energy related activities: Biotest provided consumption data for Scope 1 and Scope 2 emissions for each site based on consumption invoices. Renewable energy sources were confirmed, except for one site due to uncertain procurement. Emission fac‐ tors are based on IEA data.
Category 4 Upstream transport and distribution: Due to a lack of primary data, a simplified calculation approach was chosen. Biotest provided the total weight of production materials and their countries of origin. As exact data was not available for each specific delivery address, or it would have been too costly to collect all the exact locations, capital cities were used as a proxy instead. This means that for transport emissions calculations it was assumed that goods or people were transported between capital cities, even though the actual transport routes may be different. Transport distances were calculated using an EcoAct tool with capital cities as proxies. Multi‐ modal journeys were split and DEFRA emission factors multiplied by tonne‐kilometres. Flight distances were checked and gaps filled with EcoAct data. For air freight deliveries, the 'last mile' was also taken into account. Emissions were calculated by mode of transport.
Category 5 Waste generated from operations: Based on primary data on waste generation, waste indicators were compared with DEFRA emission factors by waste type and treatment method. Missing indicators were imputed with appropriate factors, assuming a closed loop for recycled waste. Emissions were calculated by multiplying the DEFRA factors by the volume of waste.
Category 6 Business travel: For Biotest AG, primary data collected on business trips was provided and used to extrapolate sales offices. Emissions were calculated by multiplying the distances travelled by DEFRA emission factors (car, train, plane). Taxi rides and hotel stays were calculated based on CEDA emission factors and total expenditure.
Category 7 Employee commuting: Biotest determined data on full‐time equivalents and home office shares.. These data were consoli‐ dated at country level and average commuting distances and home office energy consumption were estimated using internal calculation methods. Emissions were calculated by multiplying distances travelled by DEFRA emission factors. Home office energy consumption was calculated using IEA (International Energy Agency) and DEFRA factors.
Category 8 Assetsleased from third parties: The general ledgerfor procurement processes, a general ledgerfor purchasing and additional Biotest data were used for the calculation. Expenditure categories were assigned to CEDA emission factors. Emissions were calculated by multiplying the expenses by the CEDA factors. Leased vehicles were reported without emissions to maintain consistency with Grifols' calculations. Approved emission factors cannot be redistributed.
Category 12: End‐of‐life treatment of sold products: Biotest provided data on the quantity of material sold, with a focus on packaging. Since medical products are used up completely, their disposal was not taken into account. Recycling rates were determined on the basis of secondary research. Non‐recycled waste was assumed to be sent to landfill. Emissions were calculated by multiplying the waste vol‐ ume by DEFRA emission factors.
Category 15 Investments: Investments were calculated on the basis of equity and turnover. Emissions were calculated by multiplying the enterprise value by a sector‐specific emission factor. Scope 1 and Scope 2 GHG intensity was determined using Factset data and CDP sector emissions from 2021, with planned updates in future inventories.
Greenhouse gas capture and storage is not relevant for Biotest as the company does not operate in a FLAG‐relevant sector and has no process in place to capture greenhouse gas emissions. Negative greenhouse gas emissions have therefore not been included in the calculation of the greenhouse gas inventory.
Results of the greenhouse gas balance
The GHG balance for the reporting year 2024 shows:
Table III: GHG emissions39
| GHG emissions | Base year 2023 | 2023 | 2024 | Change | 2035 | 2045 |
|---|---|---|---|---|---|---|
| Scope 1 greenhouse gas emissions | ||||||
| Scope 1 gross GHG emissions (t CO2e) | 15,210.0 | 15,210.0 | 16,934.8 | 11.34% | 12,168.0 | 1,521.0 |
| Percentage of Scope 1 greenhouse gas emissions from regulated emissions trading systems (in %) |
– | |||||
| Scope 2 greenhouse gas emissions | – | |||||
| Location‐based Scope 2 GHG gross emis‐ sions (t CO2e) |
– | 11,457.0 | 12,430.9 | 8.50% | 9,165.6 | 1,145.7 |
| Market‐related Scope 2 GHG gross emis‐ sions (t CO2e) |
21,905.0 | 21,905.0 | 25,092.0 | 14.55% | 17,524.0 | 2,190.5 |
| Significant Scope 3 greenhouse gas emissions |
||||||
| Total indirect (Scope 3) gross GHG emis‐ sions (t CO2e) |
102,043.0 | 102,043.0 | 92,215.0 | ‐9.63% | 81,634.4 | 10,204.3 |
| 1 Purchased goods and services services |
64,218.0 | |||||
| [Optional sub‐category: cloud compu‐ ting and data center services] |
– | |||||
| 2 Capital goods | 9,545.3 | |||||
| 3 Activities related to related to fuels and energy (not included in Scope 1 or Scope 2) |
6,272.1 | |||||
| 4 Upstream transportation and distribution |
4,746.8 | |||||
| 5 Waste generation in operations |
4,866.3 | |||||
| 6 Business travel | 452.6 | |||||
| 7 Commuting employees | 1,833.4 | |||||
| 8 Upstream leased assets leased assets |
175.0 | |||||
| 9 Downstream transportation | – | |||||
| 10 Processing of sold products products |
– | |||||
| 11 Utilization of sold products products |
– | |||||
| 12 Treatment of products at the end of life |
5.9 | |||||
| 13 Downstream leased assets leased assets |
– | |||||
| 14 Franchises | – | |||||
| 15 Investments | 100.4 |
39 The figures for 2023 are unauditet.
| Total GHG emissions | ||||||
|---|---|---|---|---|---|---|
| Total GHG emissions (location‐based) (t CO2e) |
128,710.0 | 128,710.0 | 121,580.7 | ‐5.54% | 102,968.0 | 12,871.0 |
| Total GHG emissions (market‐related) (t CO2e) |
139,158.0 | 139,158.0 | 134,241.8 | ‐3.53% | 111,326.4 | 13,915.8 |
Table IV (E1‐AR54): GHG Intensity per net revenue
| GHG intensity per net revenue | 2024 |
|---|---|
| Total GHG emissions (location‐based) per net revenue (t CO2e/Mio. EUR) |
205.0 |
| Total GHG emissions (market‐related) per net revenue (t CO2e/Mio. EUR) |
226.4 |
Net income
Table V (E1‐AR55): Net income
| Net revenues | 2024 |
|---|---|
| Net revenue used to calculate greenhouse gas intensity | € 592,854,448.52 |
| Net revenue (other) | € 133,373,594.17 |
| Total net revenue (in the financial statements) | € 726,228,042.69 |
Internal carbon pricing (E1‐8)
To date, Biotest AG has not implemented an internal carbon pricing system. In the future, it will be necessary to assess whether carbon pricing would help the company to ensure that measures are taken to achieve its climate targets and to guarantee long‐term planning security.
F.II.2 E3 WATER AND MARINE RESOURCES
Impact, risk and opportunity management
Definition and connection with the sustainability strategy and business model
At Biotest AG, we recognise the vital role water plays in our production and processing of plasma. We are committed to managing this precious resource sustainably, recognising its significant ecological impact and its role in ensuring the long‐term resilience of our com‐ pany. As part of our comprehensive sustainability strategy, we have established clear targets and effective measures to minimise water withdrawal. Our environmental strategy is explicit in its goal to reduce water withdrawal by 2% annually compard to the baseline year 2023. We also take into account financial risks associated with water scarcity, rising water prices and possible regulatory restrictions.
Governance of the water strategy
Effective management of the water strategy is essential to enable sustainable change and ensure long‐term improvements. Biotest AG has therefore established comprehensive governance mechanisms:
- Central management: The water strategy is coordinated by the Portfolio Committee Sustainability and the Review Board Sus‐ tainability. The Review Board Sustainability regularly informs the Board of Management about all sustainability measures.
- Internal control system: A comprehensive KPI monitoring system is being implemented to review progress and identify areas for improvement on a quarterly basis. It also ensures that the defined standards are met at the production site.
Adapting strategy: Adjustments are made on an ongoing basis based on risk assessments, regulatory developments and feed‐ back from stakeholdersin the production areas. This allowsthe waterstrategy to evolve dynamically in line with new scientific knowledge and regulatory requirements.
Description of processes for identifying and assessing significant impacts, risks and opportunities related to water and marine resources (IRO‐1)
As part of the materiality analysis, the significance of the issue of water withdrawal at Biotest AG was defined as material. Water use plays a critical role both in the production processes and in the upstream supply chain. The analysis is based on internal data and stake‐ holder consultations, as described in the "Stakeholder Involvement" section of the sustainability strategy.
Specifically, the following impacts and risks related to water and marine resources have been identified as material:
Negative impact
Contribution to water scarcity due to high water withdrawal caused by activities within its own operations. Biotest requires large quantities of drinking water, especially for production.
The issue of water scarcity has the potential to impact local communities, with industries often being supplied with water before private households. In the event of a water emergency, restrictions may be imposed on households. Additionally, there is a possibility of water resources being contaminated through industrial processes. Measuresto prevent water pollution and ensure water quality are therefore an integral part of the strategy.
For several years, Biotest AG has been pursuing measures to optimise the use of water in production. Biotest AG has also been dealing with the issue of water treatment for many years.
- The identification and evaluation of the most important water‐related effects is carried out by the responsible departments, which on the one hand observe the water traffic light of the city of Dreieich and on the other hand work together with those responsible for production to continuously optimise the use of water in production.
- This has already been achieved through the installation of Water forInjection (WFI)systems, which reduce water consumption to the necessary minimum, and the installation of a wastewater treatment plant for recirculation into the municipal wastewatersystem. WFI is a highly purified form of water used in the manufacture of drugs. It meetsstringent phar‐macopeial standards and is produced through processes like distillation or membrane‐based systems to eliminate con‐taminants. WFI is essential to ensure patient safety when administering medications directly into the body.
Concepts related to water and marine resources (E3‐1)
The sustainable use of water is a central pillar of Biotest AG's corporate strategy. Water efficiency is considered not only for eco‐ logical reasons, but also as an economic factor, since optimised water use lowers operating costs and reduces regulatory risks.
- Biotest AG pays particular attention to the Dreieich water area by monitoring water availability. For example, it uses the Dreieich municipal water meter to continuously monitor waterstresslevels and works closely with local authoritiesto identify risks at an early stage.
- Strategic approach: Our water use and conservation measures are based on the Water Framework Directive 2000/60/EC and international best practices for sustainable water management.
- Stakeholder engagement: Regular dialogue is already in place with local authorities (City of Dreieich) and the company is informed about the current situation regarding water use by means of a water traffic light. In the future, further stakeholders, including suppliers, will be included in order to identify water risks at an early stage and to develop solutions together – if necessary also along the supply chain.The future involvement of stakeholders will be carried out more systematically through surveys and sustainability forums.
- Responsibilities: The further development and implementation of the strategy for sustainable water use is carried out under the leadership of the Executive Boardin collaboration with the environmental team, the Corporate Sustainability department, and relevant technical and production departments. Quarterly reporting to the Portfolio Committee Sutainability ensures continuous evaluation.
Targets related to water and marine resources (E3‐3)
Biotest AG has set itself the ambitious target of reducing water withdrawal by 2% annually, based on the 2023 baseline of 490,368 m3. The company aims to achieve an overall reduction of 20% by 2035. In addition, innovative water treatment processes are to be imple‐ mented to further increase efficiency.
- Reduction of water withdrawal: Annual reduction of 2%, with an interim target of 10% until 2030 and an overall reduction of 20% until 2035.
- Measurement and monitoring: Progress is documented in quarterly reports to the Portfolio Committee Sustainability and reported to the Review Board Sustainability. Water use is measured in m³ per litre of plasma produced and published annually in the Sustainability Report.
Methods and assumptions for determining the target
- Database: The objective is based on an analysis of historical water consumption data from the last five years (2018–2023) in order to derive realistic reduction potentials.
- Calculation methodology: The reduction targets are based on best practices in the pharmaceutical industry and on bench‐ marks of comparable companies with water‐intensive production processes.
Measures and resources related to water and marine resources (E3‐2)
- Use of water‐saving technologies and process optimisation to reduce water consumption at all sites. This includes optimising cleaning processes and expanding WFI facilities.
- Develop site‐specific water management plans for the high water stress site in Dreieich, including detailed risk analyses and adaptation strategies, with initial implementation until 2026.
- In the future, there should be close collaboration with suppliers to identify and mitigate water risks along the entire value chain, which should be reviewed annually and, where appropriate, contractual sustainability requirements.
Key figures
Water abstraction and reuse (E3‐4)
Key figures and methods:
- Total water withdrawal: Based on the reference year 2023, annual reporting of water withdrawal in m³ for the production site Dreieich.
- Water withdrawal in areas subject to water stress: Detailed monitoring of sites with high water stress (here: Dreieich produc‐ tion site).
- Recovery and reuse: Focus on increasing the volume of reused water through circular economy initiatives.
- Water quality: Monitoring and measures to ensure the quality of the water resources that are withdrawn and reused by external analyses.
In 2024, Biotest AG's water withdrawal will total 464,872.0 m3.
Table VI: Water abstraction
| Water withdrawal in m3 | 2024 |
|---|---|
| Total water withdrawal | 464,872.0 |
| Total water withdrawal in areas affected by water risks, including areas with high water stress |
– |
| Total volume of water recycled and reused | – |
| Total volume of water stored | – |
| Change in water storage | 9,221.5 |
| Water intensity per million net revenue (m3/EUR million) | 640.1 |
F.II.3 E5 RESOURCE UTILISATION AND CIRCULAR ECONOMY
Management of impacts, risks and opportunities
Definition and connection with the sustainability strategy
Biotest AG regards the circular economy as a central element of its sustainability strategy. This concept aims to reduce the consumption of primary raw materials and minimise waste by reusing and recycling materials and innovatively designing products. The focus of our resource inflows, outflows and waste management reflects our goal of promoting sustainable production processes and establishing a closed material cycle. Our vision is to not only reduce environmental pollution by integrating circular economy principles, but also to meet regulatory requirements and achieve long‐term economic benefits.
Governance of resource use and circular economy
- Centralised control: Resource utilisation strategy is coordinated by the Portfolio Committee Sustainability and the Review Board Sustainability. The Review Board Sustainability regularly informs the Board of Management about all sustainability measures. Responsibility for implementing the strategies lies with the Board of Management and the sustainability manage‐ ment team in cooperation with the specialist departments. Progress is ensured by monitoring specific KPIs. The Sustainability Review Board regularly informs the Board of Management about all sustainability measures.
- Internal control system: Based on the KPI monitoring, which relates to the amount of waste (tons) and the increase in the recycling rate, progress and identified optimisation potential are reviewed quarterly. In addition, it is ensured that the defined standards are met at the Dreieich production site.
- Strategy adjustment: Based on risk assessments, regulatory developments and stakeholder feedback, adjustments are con‐ tinuously made during the year. The strategy is adjusted annually based on the latest figures.
Concepts related to resource use and circular economy (E5‐1)
Strategic focus: Our measures to use and conserve resources are aligned with the possibilities for the specific area of plasma production. The greatest lever for recycling materialsfor plasma production liesin the rectification of ethanol, asthis accounts for by far the largest amount of recyclable material at Biotest. In addition, we are investigating the increased use of recycled materials in all areas, including packaging. In doing so, we ensure compliance with international standards and certifications. Socio‐ecological aspects are integrated into the procurement system. We give priority to waste prevention measures (waste hierarchy). Where this is not possible, we focus on reuse and recycling. Stakeholder engagement in relation to resource use is currently still carried out as needed. This means that the respective departments are in dialogue with suppliers and author‐ ities. In the future, the stakeholder dialogues are to be systematised internally in order to identify resource‐related risks at an early stage and to develop solutions together with the production areas involved.
Responsibilities: The further development and implementation of the strategy is carried out under the direction of the Board of Management in cooperation with the environmental team, the Corporate Sustainability department and the specialist de‐ partments in production.
Long‐term goal: Biotest AG has set itself the ambitious goal of increasing the proportion of recycled materials to 30% by 2030 and reducing the annual volume of waste by 2%.
Description of processes for identifying and assessing significant impacts, risks and opportunities related to resource use and circularity (IRO‐1)
As part of the materiality analysis, Biotest AG has identified the following impacts as material in the area of resource utilisation:
Negative impacts
- Extraction and/or use of renewable resources through activities within the company's own operations
- Extraction and use of renewable resources through activities within the company's upstream or downstream value chain
- Generation of non‐recyclable waste through the company's own activities. In manufacturing processes, waste material may be generated (some of which may be reused or recycled). Packaging and other waste used in or generated by production processes may contribute to environmental pollution if not handled properly.
Risks
- Increased monitoring and evaluation of the supply chain. Investment in additional controls and supplier due diligence.
- Increased costs due to the need to implement circular product design. The transition to a circular economy requiressignificant up‐front investment in new technologies to optimise and reuse recycled materials.
The main topics related to resource utilisation and the circular economy are primarily addressed by the departments in the Industrial Operations division.
Information on the procedures:
Review of assets and operations: Regular analysis of material and waste flows as part of waste management (waste reporting, weight control, etc.) provides a sound assessment of our resource efficiency. Methods such as process analysis and supply chain analysis are used.
Scenario analysis: Risks from rising raw material costs and regulatory changes are monitored, while opportunities arise from recycling technologiessuch as ethanol rectification and innovative product designsthat reduce costs and create long‐term competitive advantage.
Consultation with stakeholders: We receive valuable feedback from our dialogue with stakeholders, particularly in production, which in turn are in dialogue with suppliers and authorities, particularly on topics such as waste management and recycling. This feedback is fed directly into the development of our sustainability strategy at the fortnightly meetings of the environmental team.
Business areas and resources: Our main resources are plasma, ethanol and packaging materials, as well as other substances used in production. At the same time, production waste from plasmapheresis and by‐products are generated, which are processed by strict waste management systems.
Measures and resources related to resource use and the circular economy (E5‐2)
The specific measures and milestones for achieving the targets are currently being worked out in detail and will be published in the following reporting period. The main focus here is on resource efficiency measures, such as investments in innovative technologies for recycling valuable raw materials (z.B. ethanol rectification40), minimising material losses and increasing efficiency.
40 Rectification is a thermal separation process and represents a further development of distillation or a series connection of many distillation steps. In this process, liquid mixtures are broken down into their components. The process is used in industry for the purification and extraction of alcohol.
Financial resources: In order to achieve the goals of a circular economy, the necessary investments for the coming reporting period are currently being determined.
Targets related to resource use and the circular economy (E5‐3)
Targets of the resource utilisation and the circular economy
Measurable targets in relation to the base year 2023 (11.551,16 t):
- 2% annual reduction in waste volume through prevention and reuse
- For the defined target of increasing the share of recyclable materials to 30% by 2030, the baseline for the following reporting period is determined by recycling.
Monitoring and reporting: The results of waste management are documented for the waste management officer in accordance with the legal requirements. The targets initially apply to Biotest AG and all subsidiaries that fall under the reporting requirements. This initially includes internal processes, but also affects the downstream value chain in various places, particularly with regard to suppliers of raw materials and disposal companies. The base year 2023 was set with 11,551.16 tons of waste. The target is based on internal waste analyses, regulatory requirements and best practices in the circular economy. The data basis is provided by internal waste reports and quantity analyses, EU requirementsfor the circular economy, in particular the Waste Framework Directive (2008/98/EC), industry bench‐ marks to compare the recycling rate for ethanol with comparable companies in the pharmaceutical industry.
Biotest AG's waste hierarchy is based on the requirements of the EU Waste Framework Directive (2008/98/EC) and followsthe principles of circular economy. Waste is treated according to its environmental impact in a five‐step hierarchy. Biotest AG's waste management objectives primarily relate to avoidance, reuse and recycling.
Resource inflows (E5‐4):
All products are manufactured from human blood plasma. This is separated into its individual components (albumin, clotting factors and immunoglobulins) in a common production process using ethanol. These fractions are then used to make the final products. For these reasons, the two most important resource inputs are the following.
Blood plasma: The key raw material is human blood plasma, a renewable natural product that is voluntarily donated by healthy donors. In 2024, Biotest AG received 1,762,074.434 litres of plasma, which corresponds to a weight of around 1,814,936.67 kilograms.
Ethanol: Biotest uses ethanol in the Cohn fractionation process to obtain therapeutic proteins from plasma, in particular for immunoglobulins and albumin. In 2024, 2,299,640 kilos of alcohol with an ethanol content of 2,997,526 litres were purchased for Biotest AG.
The quantities are determined on the basis of purchase postings and delivery notes in the SAP system.
Packaging and other production materials are required, but are of secondary importance: In addition to plasma, various other materials are required for the production and packaging of the drugs. These include not only the drug packaging made of cardboard, glass bottles and items such as plastic bags. It is not yet possible to give percentages for the quantity and weight of sustainably sourced products and services, intermediate products, raw materials and consumables in this reporting year. These will be collected for the next reporting period.
Resource outflows (E5‐5):
Biotest AG is active in the field of blood plasma production, which generates specific waste streams that include both regulated and general types of waste. These can be divided into various categories:
- Biological and medical waste
Plasma residues: Blood plasma that cannot be reused or is contaminated.
- Filtration and cell residues: Waste from blood plasma fractionation.
- Disposable medical devices: Pipettes, syringes, gloves and protective equipment contaminated with biological substances.
2. Chemical waste
- Solvent waste: Ethanol and other chemicals from the Cohn fractionation process.
- Reagents and laboratory chemicals: Unused or expired chemicals from analytical processes.
- Buffer solutions and process fluids: Chemical solutions from protein purification and stabilisation.
3. Packaging and production waste
- Primary packaging: Glass bottles, plastic containers, blister packs.
- Secondary packaging: Cardboard boxes, plastic film, pallets.
-
Labels and printed matter: Packaging labels, instruction leaflets.
-
Dangerous waste according to EU directives
-
Contaminated production residues: Substances contaminated with biological or chemical hazardous substances.
- Old medicines and unsaleable batches: Products that must be disposed of due to regulatory or quality requirements.
- Waste oil and lubricants: Residues from technical production equipment.
5. Energy and fuel wastes
- Water treatment residues: Waste water from production and cleaning processes.
- Filter materials and membranes: Filtration systems used in blood plasma and chemical processes.
- Electronic waste: Obsolete or defective laboratory and production equipment.
These waste streams are of central importance to the pharmaceutical industry, and to Biotest AG in particular, and are subject to strict legal and regulatory requirements. Disposal and recycling processes must be carried out in accordance with EU waste directives, GMP standards and national regulations.
Biotest AG records and assesses the recyclability of its products using a combination of direct measurements and model calculations. Material flows, waste generation and recycling rates are documented. The data is collected on the basis of direct measurements and weighing records provided by the supplier.
Classification according to recycling principles is based on defined criteria: blood plasma is considered a renewable resource, ethanol could reach a recycling rate of 30% by 2030, and packaging materials are expected to be increasingly made from recycled raw materials in the future. The data is validated internally on an ongoing basis.
Total waste volume:
In 2024, the total amount of waste was 11,816.8 tonnes. Of this, 10,072.40 tonnes was recycled. The majority of this, 9,547.43 tonnes, consisted of waste alcohol, a by‐product of ethanol production. Detailed annual documentation is provided in the waste report. The total weight of materials used is measured and documented annually in tonnes.
Table VII: Waste disposal41
| Overview of waste disposal (in tons) | 2024 | 2023 | ||
|---|---|---|---|---|
| Waste diverted from dispo‐ sal |
hazardous | Reuse | – | – |
| Recycling | 9,585.8 | 9,321.6 | ||
| Other recovery operations | – | – | ||
| Total | 9,585.8 | 9,321.6 | ||
| non‐hazardous | Reuse | – | – | |
| Recycling | 486.6 | 443.3 | ||
| Other recovery operations | 1,468.9 | 1,287.2 | ||
| Total | 1,955.5 | 1,730.5 | ||
| Waste directed to disposal | hazardous | Incineration with energy recovery | – | – |
| Incineration without energy recovery | 57.8 | 56.7 | ||
| Landfill disposal | 2.0 | 2.1 | ||
| Other disposal operations | 75.4 | – | ||
| Total | 135.2 | 58.8 | ||
| non‐hazardous | Incineration with energy recovery | 73.5 | – | |
| Incineration without energy recovery | – | 414.8 | ||
| Landfill disposal | 66.7 | 25.4 | ||
| Other disposal operations | – | – | ||
| Total | 140.3 | 440.2 | ||
| Total amount of non‐recycled wast | 275.5 | 499.0 | ||
| Percentage of non‐recycled waste | 2.33% | 4.32% | ||
| Total amount of waste | 11,816.8 | 11,551.2 |
F.II.4 DISCLOSURES IN ACCORDANCE WITH ARTICLE 8 OF REGULATION 2020/852 (TAXONOMY REGULATION)
Reporting in accordance with EU taxonomy
The European Green Deal is a strategic initiative by the European Union (EU) aimed at achieving climate neutrality by 2050. A key element of this action plan is Regulation (EU) 2020/852, also known as the 'EU Taxonomy Regulation'. This regulation serves as a classification system for environmentally sustainable economic activities, with the objective of directing capital flows towards sustainable investments.
In the context of the EU Taxonomy Regulation, Biotest AG is obliged to provide information on its revenues (UE), capital expenditures (CapEx) and operating expenditures (OpEx) that are related to 'environmentally sustainable' economic activities. According to Article 3 of the EU Taxonomy Regulation, economic activities are considered 'environmentally sustainable' or taxonomy‐conform if they make a significant contribution to one or more environmental targets, do not significantly harm the other environmental targets and meet the requirements for compliance with minimum protection.
The environmental objectives to be reported on for 2024 are 'climate protection', 'adaptation to climate change', 'sustainable use and protection of water and marine resources', 'transition to a circular economy', 'pollution prevention and control', and 'protection and restoration of biodiversity and ecosystems'. In addition to the Delegated Regulation (EU) 2021/2139 of the European Commission of
21 November 2023 on the technical screening criteria for the climate‐related environmental objectives, this includes the Delegated Regulation (EU) 2021/2178 of the European Commission of 21 November 2023 on the content and presentation of the EU taxonomy pursuant to Art. 8 of the EU Taxation Regulation and the Delegated Regulation (EU) 2023/2486 of the EU Commission (published in the EU Official Journal on 21 November 2023) on the technical screening criteria for non‐climate related environmental objectives. The following statements provide a comprehensive initial discussion of the taxonomy capability and conformity of existing economic activities in relation to environmental objectives 1 to 6. The taxonomy compliance of environmental objectives 3 to 6 will be reported for the first time in the 2024 financial year.
Economic activities eligible for taxonomy
In previous years, an impact analysis was carried out to determine the economic activities eligible for taxonomy, which was used as a starting point in this year's determination of the economic taxonomy‐eligible activities of Biotest.On the basis of this impact analysis, we updated and supplemented the impact analysis for 2024 as part of a working group consisting of a large number of departments and representatives of our subsidiaries.The following economic activities that are eligible for taxonomy have been identified:
| Economic activities | Biotest AG | |
|---|---|---|
| 1.2 | Manufacture of pharmaceuticals | Production of biological preparations for haematology, clinical immunology and intensive care medicine |
| 2.4 | Remediation of contaminated sites | Removal of old industrial contamination from the previous owner on part of the site (building L6) |
| 4.1 | Production of electricity by photovoltaic technology |
Operation of own solar system |
| 4.9 | Transmission and distribution of electricity |
Operation of own medium and low voltage distribution boards on the company premises |
| 4.25 | Production of heating/cooling from waste heat |
Operation of heat exchangers to utilise waste heat from waste water |
| 4.30 | High‐efficiency cogeneration of heat and cooling from fossil gaseous fuels |
Operation of own gas‐powered combined heat and power plants |
| 5.3 | Construction, expansion and operation of wastewater collection and treatment systems |
Extension of the sewer system on the company site. |
| 6.5 | Transport by motorcycles, passenger cars and light commercial vehicles |
Operation of a fleet of vehicles consisting of passenger vehicles. |
| 6.6 | Freight transport by road | Operation of the company's own commercial vehicles for the transport of goods. |
| 7.2. | Renovation of existing buildings | Construction and civil engineering works or their preparation. |
| 7.3 | Installation, maintenance and repair of energy‐efficient appliances |
Maintenance and repair work on buildings (e.g. heating, cooling and air conditioning systems, rearrangement of lighting). |
| 7.5 | Installation, maintenance and repair of equipment for measuring, controlling and managing the energy performance of buildings |
Software maintenance for building energy management |
|---|---|---|
| 8.1 | Data processing, hosting and related activities |
Operation of two data centres |
In relation to the taxonomy‐eligible CapEx, economic activities 4.1 'Electricity generation using photovoltaic technology' and 4.25 'Generation of heat/cold from waste heat' are reported. For the reportable economic activities 1.2 'Manufacture of medicinal products', revenues, CapEx and OpEx are reported. For the economic activities '6.5 "Carriage of goods by motorcycles", 6.6 "Carriage of goods by road", 7.2 "Renovation of existing buildings", 7.5 'Installation, maintenance and repair of equipment for measuring, controlling and managing energy performance in buildings' and 8.1. 'Data processing, hosting and related activities' are reported for both CapEx and OpEx. In connection with economic activity 7.3. 'Installation, maintenance and repair of energy‐efficient equipment', Opex is reported.
Taxonomy‐compliant economic activities
The procedure for verifying compliance with the taxonomy was as follows
- Verification of compliance with the technical screening criteria for each economic activity classified as taxonomy‐eligible
- Verification that there is no significant harm to other environmental objectives (DNSH)
- Verification of compliance with minimum social standards
In addition to the degree of taxonomy readiness, the proportion of taxonomy conformity among the taxonomy‐ready economic activities was also collected and presented using the mandatory reporting templates.
As in the previous year, the above‐mentioned classifiable economic activities for 2024 relate to the environmental objective 'Climate protection'. Excluding economic activities 1.2 'Manufacture of pharmaceuticals' and 2.4 'Remediation of contaminated sites', which fall under the environmental objective 'Pollution prevention and control'. The key figures are based on the accounting policies used for financial reporting. In terms of the wording and terms used in the EU Taxonomy Regulation and the delegated acts, the additional publications of the European Commission in the form of FAQs and the 'Questions and Answers' published by the IDW were used as a guide as far as possible.
The Delegated Regulation (EU) 2021/2178 provides for a calculation of the revenue KPI, CapEx KPI and OpEx KPI in Annex I, sections 1.1.1, 1.1.2 and 1.1.3. Based on this requirement, assignments for calculating taxonomy readiness were made using information from the finance department. Further information on revenues can be found in the notes to the consolidated income statement. Further information on CapEX can be found in the notes to the consolidated balance sheet (intangible assets, property, plant and equipment, lease liabilities). Further information on OpEx can be found in the notes to the consolidated income statement (other operating expenses, lease liabilities).
Revenue‐KPI
For Biotest AG, activity 1.2 'Manufacture of pharmaceuticals' was identified as a revenue‐relevant, taxonomy‐capable economic activity for the 2024 financial year, taking into account the catalogue of criteria. In this context, 81.63% of Biotest AG's revenues (previous year: 71.28%) were classified as taxonomy‐capable.
The technology transfer and licence agreement concluded in 2023 between Biotest AG, Dreieich, Germany, and Grifols, S.A., Barcelona, Spain, will continue to contribute to the value creation of the Biotest Group in 2024. The resulting amount of €126.8 million in 2024 is to be recognised as revenue in accordance with IFRS and represents an exceptional item that is not part of the ordinary
business activities of the Biotest Group. Similarly, revenue of €6.6 million from the sale of goods does not fall under 1.2 Manufacture of pharmaceuticals. The taxonomy‐compliant revenue from these two items is 0%.
CapEx‐KPI
The basis for calculating capital expenditure (denominator) includes additions to property, plant and equipment in accordance with IAS 16 and intangible assets in accordance with IAS 38 and rights of use in accordance with IFRS 16 before depreciation and any revaluations for the financial year.
According to Annex I, point 1.1.2.2 of Delegated Regulation (EU) 2021/2178, CapEx KPI represents share (numerator) of capital expenditure either related to taxonomy‐adjusted economic activities (a), related to plans to expand or achieve environmentally sustainable economic activities (CapEx plans) (b) or related to purchases of products and services from taxonomy‐adjusted economic activities (c).
For the financial year 2024, Biotest AG reports 97.13% taxable CapEx (2023: 64.03 %) and 0 % taxable CapEx. The higher proportion of tax‐compliant CapEx compared to the previous year is due to the fact that long‐term rental contracts for the newly opened plasma collection centres were capitalised in 2023 and thus included in the calculation.
OpEx‐KPI
The underlying operating expenses (denominator) include direct non‐capitalised costs related to research and development, building renovation, short‐term leases, maintenance and repairs.
The OpEx KPI, as defined in Annex I, Section 1.1.3.2 of Delegated Regulation (EU) 2021/2178, shall be the proportion of operating ex‐ penditure (numerator) falling under one of the following categories:
- a) Operating expenditure directly related to a taxonomy‐aligned economic activity,
- b) Expenditure within a CapEx plan to expand or achieve an environmentally sustainable economic activity, or
- c) Costs of purchasing products or services that originate from a taxonomy‐aligned economic activity.
For the 2024 financial year, Biotest AG reports 87.62 % taxonomy‐capable OpEx (previous year: 93.84 %) and 0 % taxonomy‐compliant OpEx. The reason for the change in taxonomy‐capable OpEx compared to the previous year is primarily due to the fact that, in contrast to 2023, no expenses from the Technology Transfer and Licence Agreement were included in the calculation in 2024.
Technical evaluation criteria
Revenue and CapEx (a):
For the 2024 financial year, taxonomy conformity for environmental objectives 3‐6 was to be examined for the first time. Currently, not all of the technical evaluation criteria specified by the EU for making a significant contribution to achieving the environmental objective of pollution prevention and control are met.
Cap Ex (c) und OpEx (c):
For this year's analysis of the technical evaluation criteria, a review of compliance was carried out. When reviewing the technical evalu‐ ation criteria based on the own activities of Biotest AG, no conformity could be achieved.
Compliance with minimum safeguards
In order to verify compliance with the minimum safeguards requirements pursuant to Article 18 of the EU Taxonomy Regulation, Biotest was guided in particular by the recommendations ofthe "Final Report on Minimum Safeguards" published by the Platform on Sustainable Finance in October 2022, as well as by the Communication 2023/C 211/01 of the EU Commission of 16 June 2023. Biotest AG has various processes and guidelines in place for dealing with human rights (including employee rights), corruption and bribery, taxes and fair com‐ petition. Nevertheless, we have come to the conclusion that the formal requirements of the EU Taxonomy Regulation regarding compli‐ ance with the minimum safeguards cannot be met. For future reporting, we aim to formalise and document the processes in such a way that Biotest AG will meet the minimum safeguards requirements in the future.
Report form Sales‐KPI
| DNSH criteria ('Does | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Financial year 2024 | Year 2024 | Substantial Contribution Criteria | Not Significantly | ||||||||||||||||
| Harm') (h) | |||||||||||||||||||
| Economic Activities (1) Code | (2) | Turnover (3) | Propor‐ tion of Turnover 2024 (4) |
(5) Mitigation Change Climate |
(6) Adaption Change Climate |
(7) Water |
(8) Pollution |
(9) Economy Circular |
(10) Biodiversity |
(11) Mitigation Change Climate |
(12) Adaption Change Climate |
(13) Water |
(14) Pollution |
(15) Economy Circular |
(16) Biodiversity |
(17) Safeguards Minimum |
Pro‐ por‐ tion of Taxon‐ omy‐ aligned (A,1) or ‐eli‐ gible (A.2.) turno‐ ver, 2023 (18) |
Cate‐ gory enab‐ ling activity (19) |
Cate‐ gory transi‐ tional acti‐ vity (20) |
| EUR | % | Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y/NY/NY/NY/NY/NY/NY/N | % | E | T | ||||||||
| A. TAXONOMY‐ELIGIBLE ACTIVITIES | |||||||||||||||||||
| A.1. Environmentally sustainable activities (Taxonomy‐aligned) | |||||||||||||||||||
| Turnover of environmen‐ | |||||||||||||||||||
| tally sustainable activities (Taxonomy‐aligned) (A.1) |
0 | 0 | 0% | 0% | 0% | 0% | 0% | 0% | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | |||
| Of which Enabling | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | E | ||
| Of which Transitional | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | T | |||||||
| A.2 Taxonomy‐Eligible but not environmentally sustainable activities (not Taxonomy‐aligned activities) (g) | |||||||||||||||||||
| EL; | EL; | EL; | EL; | EL; | EL; | ||||||||||||||
| N/EL | N/EL | N/EL | N/EL | N/EL | N/EL | ||||||||||||||
| 1.2 Manufacture of | PPC | (f) | (f) | (f) | (f) | (f) | (f) | ||||||||||||
| medicinal products | 1.2 | 592,854,448.52 | 81.6% | 71.3% | |||||||||||||||
| Turnover of Taxonomy‐eligi‐ ble but not environmentally sustainable activities (not Taxonomy‐aligned activi‐ ties) (A.2) |
592,854,448.52 | 81.6% | 0% | 0% | 0% | 82% | 0% | 0% | 71.3% | ||||||||||
| A. Turnover of Taxonomy el‐ igible activities (A.1+A.2) |
592,854,448.52 | 81.6% | 0% | 0% | 0% | 82% | 0% | 0% | 71.3% | ||||||||||
| B. TAXONOMY‐NON‐ELIGIBLE ACTIVITIES | |||||||||||||||||||
| Turnover of Taxono‐ mynon‐eligible activi‐ ties |
133,373,594.17 | 18.4% | |||||||||||||||||
| TOTAL (A+B) | 726,228,042.69 | 100% |
| Proportion of turnover/Total turno‐ | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ver | |||||||||||
| Taxonomy‐aligned | Taxonomy‐eligible | ||||||||||
| per objective | per objective | ||||||||||
| CCM | 0% | 0% | |||||||||
| CCA | 0% | 0% | |||||||||
| WTR | 0% | 0% | |||||||||
| PPC | 0% | 82% | |||||||||
| CE | 0% | 0% | |||||||||
| BIO | 0% | 0% |
Reprt form CapEx‐KPI
| DNSH criteria ('Does | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Financial year 2024 | Year 2024 | Substantial Contribution Criteria | Not Significantly | ||||||||||||||||
| Harm') (h) | |||||||||||||||||||
| Economic Activities (1) Code | (2) | CapEx (3) | Propor‐ tion of CapEx (4) |
(5) Mitigation Change Climate |
(6) Adaption Change Climate |
(7) Water |
(8) Pollution |
(9) Economy Circular |
(10) Biodiversity |
(11) Mitigation Change Climate |
(12) Adaption Change Climate |
(13) Water |
(14) Pollution |
(15) Economy Circular |
(16) Biodiversity |
(17) Safeguards Minimum |
Taxon‐ omy‐ aligned pro‐ por‐ tion of CapEx, 2023 (18) |
Cate‐ gory enabling activity (19) |
Cate‐ gory transi‐ tional acti‐ vity (20) |
| Text | EUR | % | Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y/NY/NY/NY/NY/NY/NY/N | % | E | T | |||||||
| A. TAXONOMY‐ELIGI‐ | |||||||||||||||||||
| BLE ACTIVITIES | |||||||||||||||||||
| A.1. Environmentally sustainable activities (Taxonomy‐aligned) | |||||||||||||||||||
| CapEx of environmentally | |||||||||||||||||||
| sustainable activities (Tax‐ onomy‐aligned) (A.1) |
0 | 0 | 0% | 0% | 0% | 0% | 0% | 0% | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | |||
| Of which Enabling | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | E | ||
| Of which Transitional | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | T | |||||||
| A.2 Taxonomy‐Eligible but not environmentally sustainable activities (not Taxonomy‐aligned activities) (g) | |||||||||||||||||||
| EL; | EL; | EL; | EL; | EL; | EL; | ||||||||||||||
| N/EL | N/EL | N/EL | N/EL | N/EL | N/EL | ||||||||||||||
| (f) | (f) | (f) | (f) | (f) | (f) | ||||||||||||||
| 1.2 Manufacture of medicinal products |
PPC 1.2 |
34,042,463.00 | 93.6% | N/EL N/EL N/EL | EL | N/EL N/EL | 59.81% | ||||||||||||
| 4.1 Stromerzeugung mittels Fotovoltaik‐ Technologie |
CCM 4.1 |
7,793.00 | 0.0% | EL | N/EL N/EL N/EL N/EL N/EL | 1.35% | |||||||||||||
| 4.25 Production of heat/cool using waste heat |
CCM 4.25 |
279,282.15 | 0.8% | EL | N/EL N/EL N/EL N/EL N/EL | 0.53% | |||||||||||||
| 6.5 Transport by mo‐ torbikes, passenger cars and light commer‐ cial vehicles |
CCM 6.5 |
379,336.35 | 1.0% | EL | N/EL N/EL N/EL N/EL N/EL | 0.71% | |||||||||||||
| 6.6 Freight transport services by road |
CCM 6.6 |
135,403.84 | 0.4% | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | * | |||||||||
| 7.2 Renovation of exis‐ ting buildings |
CCM 7.2 |
23,000.00 | 0.1% | EL | N/EL N/EL N/EL N/EL N/EL | * |
| 7.5 Installation, maintenance and re‐ pair of instruments and devices for meas‐ uring, regulation and |
CCM 7.5 |
156,882.74 | 0.4% | EL | N/EL N/EL N/EL N/EL N/EL | 0.13% | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| controlling energy per‐ formance of buildings |
||||||||||||
| 8.1 Datenverarbeitung, Hosting und damit ver‐ bundene Tätigkeiten |
CCM 8.1 |
318,565.00 | 0.9% | EL | N/EL N/EL N/EL N/EL N/EL | 0.38% | ||||||
| CapEx of Taxonomy‐el‐ igible but not environ‐ mentally sustainable activities (not Taxon‐ omy‐aligned activities) (A.2) |
35,342,726.08 | 97.1% | 4% | 0% | 0% | 94% | 0% | 0% | 64.03% | |||
| A. CapEx of Taxonomy eligible activities (A.1+A.2) |
35,342,726.08 | 97.1% | 4% | 0% | 0% | 94% | 0% | 0% | 64.03% | |||
| B. TAXONOMY‐NON‐ ELIGIBLE ACTIVITIES |
||||||||||||
| CapEx of Taxono‐ mynon‐eligible activi‐ ties |
1,044,482.28 | 2.9% | ||||||||||
| TOTAL (A+B) | 36,387,208.36 | 100% |
| Proportion of CapEx/Total CapEx | |||||||
|---|---|---|---|---|---|---|---|
| Taxonomy‐aligned per objective |
Taxonomy‐eligible per objectivel |
||||||
| CCM | 0% | 4% | |||||
| CCA | 0% | 0% | |||||
| WTR | 0% | 0% | |||||
| PPC | 0% | 94% | |||||
| CE | 0% | 0% | |||||
| BIO | 0% | 0% |
Report form OpEx‐KPI
| Financial year 2024 | Year 2024 | Substantial Contribution Criteria | DNSH criteria ('Does Not Significantly Harm') (h) |
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Economic Activities (1) Code | (2) | OpEx (3) | Propor‐ tion of OpEx 2024 (4) |
(5) Mitigation Change Climate |
(6) Adaption Change Climate |
(7) Water |
(8) Pollution |
(9) Economy Circular |
(10) Biodiversity |
(11) Mitigation Change Climate |
(12) Adaption Change Climate |
(13) Water |
(14) Pollution |
(15) Economy Circular |
(16) Biodiversity |
(17) Safeguards Minimum |
Pro‐ por‐ tion of Taxon‐ omy‐ aligned (A,1) or ‐eli‐ gible (A.2.) OpEx, 2023 (18) |
Cate‐ gory enabling activity (19) |
Cate‐ gory transi‐ tional acti‐ vity (20) |
| EUR | % | Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y; N; N/EL (b) (c) |
Y/NY/NY/NY/NY/NY/NY/N | % | E | T | ||||||||
| A. TAXONOMY‐ELIGIBLE ACTIVITIES A.1. Environmentally sustainable activities (Taxonomy‐aligned) |
| OpEx of environmentally | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| sustainable activities (Tax‐ | 0 | 0 | 0% | 0% | 0% | 0% | 0% | 0% | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | |||
| onomy‐aligned) (A.1) | |||||||||||||||||||
| Of which Enabling | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | E | ||
| Of which Transitional | 0 | 0 | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ | 0% | T | |||||||
| A.2 Taxonomy‐Eligible but not environmentally sustainable activities (not Taxonomy‐aligned activities) (g) | |||||||||||||||||||
| EL; | EL; | EL; | EL; | EL; | EL; | ||||||||||||||
| N/EL | N/EL | N/EL | N/EL | N/EL | N/EL | ||||||||||||||
| (f) | (f) | (f) | (f) | (f) | (f) | ||||||||||||||
| 1.2 Manufacture of | PPC | N/EL N/EL N/EL | EL | N/EL N/EL | 89.22% | ||||||||||||||
| medicinal products | 1.2 | 64,792,030.28 | 81.8% | ||||||||||||||||
| 2.4 Remediation of | PPC | N/EL N/EL N/EL | EL | N/EL N/EL | 0.04% | ||||||||||||||
| contaminated sites | 2.4 | 41,313.54 | 0.1% | ||||||||||||||||
| 4.9 Transmission and | |||||||||||||||||||
| distribution of electric‐ | CCM | EL | N/EL N/EL N/EL N/EL N/EL | ||||||||||||||||
| ity | 4.9 | 102,794.93 | 0.1% | 0.13% | |||||||||||||||
| 4.30 High‐efficiency | |||||||||||||||||||
| co‐generation of | |||||||||||||||||||
| heat/cool and power | EL | N/EL N/EL N/EL N/EL N/EL | |||||||||||||||||
| from fossil gaseous | CCM | ||||||||||||||||||
| fuels | 4.30 | 162,876.30 | 0.2% | 0.19% | |||||||||||||||
| 5.3 Construction, ex‐ | |||||||||||||||||||
| tension and operation | |||||||||||||||||||
| of waste water collec‐ | CCM | EL | N/EL N/EL N/EL N/EL N/EL | ||||||||||||||||
| tion and treatment | 5.3 | 213,061.56 | 0.3% | 0.11% | |||||||||||||||
| 6.5 Transport by mo‐ | |||||||||||||||||||
| torbikes, passenger | |||||||||||||||||||
| cars and light commer‐ | CCM | EL | N/EL N/EL N/EL N/EL N/EL | ||||||||||||||||
| cial vehicles | 6.5 | 184,205.91 | 0.2% | 0.30% | |||||||||||||||
| 6.6 Freight transport | CCM | ||||||||||||||||||
| services by road | 6.6 | 47,508.92 | 0.1% | EL | N/EL N/EL N/EL N/EL N/EL | 0.10% | |||||||||||||
| 7.2 Renovation of exis‐ | CCM | ||||||||||||||||||
| ting buildings | 7.2 | 23,000.00 | 0.0% | EL | N/EL N/EL N/EL N/EL N/EL | * | |||||||||||||
| 7.3 Installation, | |||||||||||||||||||
| maintenance and re‐ | |||||||||||||||||||
| pair of energy effi‐ | CCM | EL | N/EL N/EL N/EL N/EL N/EL | ||||||||||||||||
| ciency equipment | 7.3 | 2,655,850.94 | 3.4% | 2.82% | |||||||||||||||
| 7.5 Installation, | |||||||||||||||||||
| maintenance and re‐ | |||||||||||||||||||
| pair of instruments | |||||||||||||||||||
| and devices for meas‐ | EL | N/EL N/EL N/EL N/EL N/EL | |||||||||||||||||
| uring, regulation and | |||||||||||||||||||
| controlling energy per‐ | CCM | ||||||||||||||||||
| formance of buildings | 7.5 | 233,559.74 | 0.3% | 0.29% | |||||||||||||||
| 8.1 Data processing, | |||||||||||||||||||
| hosting and related ac‐ | CCM | EL | N/EL N/EL N/EL N/EL N/EL | ||||||||||||||||
| tivities | 8.1 | 944,283.86 | 1.2% | 0.53% | |||||||||||||||
| OpEx of Taxonomy‐eli‐ | |||||||||||||||||||
| gible but not | |||||||||||||||||||
| environmentally | |||||||||||||||||||
| sustainable activities | |||||||||||||||||||
| (not | |||||||||||||||||||
| Taxonomy‐aligned | |||||||||||||||||||
| activities) (A.2) | 69,400,485.98 | 87.6% | 5.8% 0.0% 0.0% 81.9% 0.0% 0.0% | 93.84% | |||||||||||||||
| A. OpEx of Taxonomy eligi‐ | |||||||||||||||||||
| ble activities (A.1+A.2) | 69,400,485.98 | 87.6% | 5.8% 0.0% 0.0% 81.9% 0.0% 0.0% | 93.84% | |||||||||||||||
| B. TAXONOMY‐NON‐ELIGIBLE ACTIVITIES | |||||||||||||||||||
| OpEx of Taxonomynon‐ | |||||||||||||||||||
| eligible activities | 9,802,119.49 | 12.4% | |||||||||||||||||
| TOTAL (A+B) | 79,202,605.47 | 100% | |||||||||||||||||
| Proportion of OpEx/Total OpEx | ||||||||
|---|---|---|---|---|---|---|---|---|
| Taxonomy‐aligned per objective |
Taxonomy‐eligible per objective |
|||||||
| CCM | 0% | 6% | ||||||
| CCA | 0% | 0% | ||||||
| WTR | 0% | 0% | ||||||
| PPC | 0% | 82% | ||||||
| CE | 0% | 0% | ||||||
| BIO | 0% | 0% |
F.III. SOCIAL INFORMATION
F.III.1 S1 COMPANY EMPLOYEES
Concepts related to the company's employees (S1‐1)
Biotest AG defines its own workforce as all employees at the main site in Dreieich and in the plasma collection and distribution compa‐ nies in Germany and abroad. The specific requirements for employees at the plasma collection centres are considered separately, while the company‐specific topic of donors is discussed at the end of the report section.
The company is committed to the highest standards of working conditions, health, safety and equal. These aspects are particularly important for the medical staff in the plasma donation centres, who play a central role in ensuring plasma production. Biotest imple‐ ments Group‐wide measures to improve the health and safety of its employees, including training in occupational safety and the provi‐ sion of personal protective equipment.
The company places particular emphasis on involving employees in decision‐making processes and upholding freedom of association and collective bargaining. Ongoing equality and diversity programmes are in place to promote inclusion and equal opportunities. The effectiveness of these measures is regularly evaluated through internal audits and reports.
Strategic priorities and how they affect employees
Biotest regularly assesses the impact of its corporate strategy on its employees. This is done by focusing on the following:
- Expansion of production capacity: The commissioning of a new production plant requires additional skilled workers in pro‐ duction and quality assurance
- Health, quality and safety: Stricter regulatory requirements increase the demands on quality management, particularly in plasma donation centres
- Global diversification: International expansion requires increased measures for equal opportunities and intercultural skills
- Digitalisation and automation: Technological changes require targeted training and further education
- Regulatory requirements: tighter regulations on drug safety and environmental standards lead to a greater need for training
- Macroeconomic challenges: the increasing demand for drugs and geopolitical uncertainties influence personnel strategies
- Shortage ofskilled workers: It is becoming increasingly difficult to fill qualified positions, particularly in research, development and production.
- Minimisation of biomedical risks: Protective measures for employees exposed to health risks are being strengthened.
Biotest AG is committed to complying with internationally recognised standards for human rights and corporate due diligence. The company guidelines are based on the following frameworks:
- o UN Guiding Principles on Business and Human Rights: Biotest AG is committed to complying with the UN Guiding Princi‐ ples on Business and Human Rights and integrates them into its internal guidelines and human rights due diligence.
- o OECD Guidelines for Multinational Enterprises: As an international company, Biotest adheres to the OECD Guidelines for Multinational Enterprises, particularly with regard to labour standards and corporate responsibility.
o ILO Declaration on Fundamental Principles and Rights at Work: Biotest respects fundamental labour rights, including freedom of association, the elimination of forced labour and non‐discrimination.
The principles ofthese internationalstandards are incorporated in internal guidelines, including the Biotest Code of Conduct. Compliance is monitored through regular internal audits, risk assessments and compliance mechanisms. Employees and stakeholders can report potential violations of human rights and labour standards through the company's whistleblower system.
Impact, risk and opportunity management
Material impacts, risks and opportunities (IROs) and their interaction with strategy and business model (SBM‐3)
The risks and opportunities identified in relation to the workforce are incorporated directly into Biotest's strategic planning. Through continuous assessment and integration of social aspects, the company aims to ensure that regulatory compliance, talent retention and long‐term personnel development remain central components of the corporate strategy. This ensures sustainable competitiveness and minimises negative impacts on the workforce.
Risks:
- Skills shortage: The ongoing lack of qualified specialists, especially in production and quality assurance, could compromise the planned increase in production. Intensified competition for talent may compel Biotest to offer higher salaries and additional benefits, which would substantially increase personnel costs.
- Vacancies and sub‐optimal staffing: Vacancies or sub‐optimal staffing can lead to increased workloads for existing staff. This can lead to project delays, reduced innovation and inefficient operations. In the pharmaceutical industry, this could put prod‐ uct quality and regulatory compliance at risk in the long term.
- Lack of expertise: Insufficiently qualified employees can lead to quality defectsin products and services,slow down innovation processes and impair Biotest's competitiveness.
- Loss of workforce due to inadequate training: A lack of investment in education and training programmes can lead to a brain drain and the loss of expertise. This could have a negative impact on the long‐term development of the company.
- Regulatory and financial risks: Violations of employees' data protection and privacy rights could result in fines, sanctions or legal action. In addition, costs could be incurred for remediation to correct compliance violations and protect the company's image.
Opportunities:
- Increased innovation and competitiveness through a diverse workforce that brings different perspectives and promotes cre‐ ative solutions. Increased employer attractiveness through targeted equal opportunities and inclusion measures that attract new talent and increase employee satisfaction.
- Improved employee retention and reduced turnover through fair compensation structures and gender‐independent pay that offers long‐term career prospects. Optimisation of corporate performance through an inclusive work environment that in‐ creases employee engagement and strengthens collaboration.
Material positive and negative impacts
In Biotest AG's double materiality analysis, no positive impacts were defined as material. The negative impacts identified as material in the materiality analysis are described below:
- Adverse effects on data protection and IT security: Violations of data protection guidelines or security breaches in IT systems can lead to the unauthorised disclosure of employees' personal data. This can reduce the workforce's trust in the employer and lead to legal consequences as well as financial damage.
- Mental and physical stress due to harassment: Incidents of harassment in the workplace can have a significant impact on the mental and physical health of the employees concerned. This can lead to lower job satisfaction, lost productivity and increased absenteeism.
- Limited professional development: A corporate culture that prioritises operational business priorities overinvestment in train‐ ing and professional development can result in employees not taking advantage of training opportunities. This inhibits their continuous professional development, which in the long term can weaken the company's employability and innovative strength (systemic impact).
- Health and safety risks: A working environment that does not adequately protect against accidents at work, the risk of infec‐ tion or potential work‐related deaths endangers the health and safety of employees. Insufficient protective measures can lead to an increased frequency of accidents and long‐term damage to health. These negative impacts would be systemic, as they affect a large number of workers and could be intensified by structural safety deficiencies.
- Deterioration of the work‐life balance: Limited opportunities for holiday planning due to operational shortages can affect employees' work‐life balance. This can be increased by a shortage of highly qualified specialists and a high fluctuation rate, causing additional stress and overload for remaining employees (systemic impact).
- A lack of women in leadership positions can have a negative impact on the working atmosphere and the motivation and commitment of female employees in the company.
Biotest AG pursues a sustainable corporate strategy that aims to reduce CO₂ emissions and improve resource efficiency. These transi‐ tional measures have direct and indirect impacts on the company's own workforce.
Direct impacts:
- Introduction of energy‐efficient production processes requires targeted training to familiarise employees with new technolo‐ gies and procedures.
- Adaptation of production workflows to use resources more efficiently and reduce emissions.
- Introduction ofsustainable mobility solutions,such asincentivesfor using public transport or providing charging infrastructure for electric vehicles.
Indirect impacts:
- Increasing regulatory requirementsin the area of environmentalstandards may result in new skillrequirementsfor employees in relevant areas.
- Changes in the supply chain and material sourcing will require closer collaboration with purchasing and logistics employees.
- Digitalisation and automation to improve resource efficiency may change job requirements in the long term and require new skill profiles.
In order to ensure a seamlesstransition, Biotest is committed to transparent communication and the early involvement of its employees. Through regular training, workshops and information events, employees are actively involved in the change process. In addition, sug‐ gestions from the workforce for sustainable process improvements are actively encouraged and integrated into the corporate strategy.
Consideration of vulnerable groups and specific risks
It is imperative to recognise that knowledge workers are particularly affected by technological developments and require additional training, as evidenced by skills analyses. These analysesindicate that digital transformation processes bring new skillsrequirements. This training is particularly relevant for employees in scientific, technical and administrative roles, as well as production employees who have to work with new digital systems and automation technologies.
Women in or aspiring to leadership positions, as well as underrepresented groups, benefit from targeted support to overcome structural barriers. An internal analysis of the management structure demonstrated that targeted mentoring programmes and training measures can improve equal opportunities sustainably. These measures have a particular impact on employees in scientific, technical and admin‐ istrative areas, as well as production employees who wish to advance to managerial positions.
Inclusion of the entire workforce in the disclosures
Biotest includes in its figures both employees covered by collective agreements and those not covered by collective agreements, as well as the self‐employed.
Characteristics of the company's employees (S1‐6)
The following are the employees of Biotest AG:
- Permanent and temporary employees who are directly employed by Biotest.
- Full‐time and part‐time employees, regardless of the duration of their contract.
- Employees in training or dual study programmes who are integrated into the company.
- Employees at plasma donation centres.
- Trainees and working students who regularly carry out activities within the company.
This definition does not include non‐salaried employees such as external service providers, temporary employees and contractual part‐ ners along the value chain.
The employees of Biotest AG in Dreieich work in various departments. In the Research & Development department, specialised staff work on the development of innovative biopharmaceutical products. The Production & Quality Assurance department ensures the manufacture and strict control of plasma products in accordance with legal requirements. In Sales & Marketing, experienced specialists ensure a strong market presence and professional customer communication. Support functions such as IT, Human Resources, Finance and other administrative areas ensure the smooth running of the company. This interdisciplinary cooperation forms the basis for Biotest's sustained success.
Characteristics of the employees of the company (S1‐6)
In 2024, Biotest employed an average of 2,639 of people. In the same year, 364 people left the company, which corresponds to a fluc‐ tuationrate42 of 13.7 %.
Table VIII: Employees by gender
| Head count by gender | 2024 | 2023 |
|---|---|---|
| Women | 1,397 | 1,380 |
| Men | 1,269 | 1,213 |
| Non‐binary | – | – |
| Undeclared | – | – |
| Total | 2,666 | 2,593 |
Table IX (S1‐AR55): Employees by country – Total number of employees by country43
| Number of employees by country | 2024 | 2023 |
|---|---|---|
| Germany | 2,139 | 2,041 |
| Hungary | 304 | 314 |
| Czech Republic | 206 | 217 |
| Rest of the world | 17 | 21 |
| Total | 2,666 | 2,593 |
42 The fluctuation rate is calculated as the ratio of departures and employees as of 31 December.
43 The 2023 figures are unaudited.
Table X (S1‐AR55): Employees by contract type and gender44
| Employees by contract type and gen‐ der |
Women | Men | Other | Not indicated | Total |
|---|---|---|---|---|---|
| Employees | 1397 | 1269 | 0 | 0 | 2,666 |
| Permanent | 1298 | 1224 | 0 | 0 | 2,522 |
| Temporary | 99 | 45 | 0 | 0 | 144 |
| Non‐guaranteed hours | 0 | 0 | 0 | 0 | – |
| Full time | 986 | 1169 | 0 | 0 | 2,155 |
| Part time | 411 | 100 | 0 | 0 | 511 |
Diversity indicators(S1‐9)
Promoting Diversity and Inclusion
Biotest AG regards diversity as a central pillar of its corporate culture. In 2024 , the gender distribution in management positions was 67 % women and 33 % men in senior management (directors) and 31 % women and 69 % men in upper management (executives). Whether other dimensions of diversity, such as ethnicity, disability and socio‐economic background, will be considered in addition to gender in the future is still under discussion. The general targets of an inclusive corporate culture should be that all employees receive the same opportunities, regardless of gender, origin, disability or socio‐economic background. At the same time, however, Biotest still faces challenges in the implementation of inclusive measures, in particular with regard to the identification and consideration of further diversity criteria. Responsibility for the implementation of diversity and inclusion issues lies with the Human Resources department and ultimately with the Board of Management of Biotest AG. As the suitability of employees is of primary importance at Biotest, there are no specific and measurable indicators of progress. Biotest does not pursue specific targets with regard to the number of nationalities, disabilities or socio‐economic backgrounds.
Table XI: Gender distribution at the executive level
| Gender distribution at the management level |
Women | Men | Other | Not indicated | Total | |
|---|---|---|---|---|---|---|
| Executives | 2 | 1 | 0 | 0 | 3 | |
| Directors | 11 | 24 | 0 | 0 | 35 |
The age distribution reflects a balanced mix of experience and innovation and emphasises the importance of intergenerational knowledge transfer.
Age distribution in the company:
- Employees under 30 years: 503
- Employees aged between 30 and 50: 1,478
- Employees over 50: 685
In order to promote equal opportunities with regard to gender equality, we launched an external mentoring programme for women in 2024, which supports 17 participants. By 2025, we aim to expand this initiative to encompass at least 50 employees and establish an internal mentoring programme for all employees. During 2025, we will work on developing Group‐wide measures to improve gender‐ equal compensation. As gender equality is already guaranteed by the tariff structures at Biotest AG, there is no immediate need for action for the German companies. The European Pay Transparency Directive (Directive (EU) 2023/970) came into force on 6 June 2023. The Directive aims to address gender‐based wage discrimination and enhance the transparency of remuneration structures. Member
states of the European Union are required to incorporate this directive into their national legislation by 7 June 2026. Biotest will imple‐ ment the Pay Transparency Directive in 2026 in accordance with the national requirements that are in force at that time.
Methodology and assessment
Our diversity key figures are based on an SAP assessment are aligned with industry benchmarks and take into account potential meth‐ odological limitations. An external audit of the data presented here is not currently being sought.
Measures and targets related to significant impacts on the company's workforce (S1‐4, S1‐5)
Biotest AG is committed to ensuring fair compensation, flexible working time models and comprehensive social security for all employees, including medical staff in foreign plasma collection organisations. This commitment ensures that all employees, regardless of their employment status, such as fixed‐term contracts or temporary work, receive at least the statutory minimum wage or collectively agreed standards. In addition, Biotest ensures that working hours, remuneration and labour conditions comply with legal requirements and international standards. In doing so, compliance with ILO labour standards and EU working time guidelines is ensured. Specific measurable progress indicators are currently being developed for goals such as promoting diversity.
Fair remuneration (S1‐10)
Concepts, measures and key figures
Biotest AG is committed to ensuring that all employees receive appropriate compensation in accordance with legal benchmarks (e.g. collective wages according to IGBCE, minimum wage) and promotes fair and transparent career opportunities. Additional social benefits such as pension plans, childcare allowances and family‐friendly working arrangements are offered to support the long‐term security of employees. In 2024, the percentage of employees paid below the reference values for adequate remuneration was 0 %. Biotest AG complies with legal requirements in all countries, including minimum wage legislation. This commitment to fair compensation and com‐ pliance with international standards is further demonstrated by the company's dedication to ongoing review and enhancement of its remuneration policies. The company is currently working on determining detailed information on salary fairness based on the review and comparability of contracts. The Management Board of Biotest AG assumes the greatest responsibility for ensuring compliance with international standards and appropriate remuneration.
Methods and evaluation
The remuneration analysis is based on industry‐specific market benchmarks and is not currently verified by external auditors. To further improve pay equity, we regularly review pay structures and implement programmes to minimise gender pay gaps.
Remuneration parameters (S1‐16)
Gender equality in remuneration45
In 2024, the gender pay gap at Biotest AG across all occupational groups was 8.6%. This achievement was made possible through the implementation of targeted measures, including mentoring programmes for women in leadership positions and regular salary analyses.
Table XII: Gender pay gap by occupational group
| Gender pay gap by occupational group (%) |
2024 |
|---|---|
| Executives and Directors | 7.7% |
| Senior Management | 1.2% |
| Management | ‐2.9% |
| Senior professionals | 4.7% |
| Professionals | 10.4% |
| Administrative staff / Manufacturing operators |
21.5% |
The gender pay gap in our subsidiary in the Czech Republic is 16.2 %, while in our subsidiary in Hungary it is 11.83 %46.
The gender pay gap at Biotest is calculated by an external service provider in accordance with reporting requirements to the parent company Grifols.The underlying methodology, including assumptions and objective factors, is known to the HR department of Biotest AG and audited by the auditing company EY. To facilitate understanding of the data, contextual information should be integrated into the reporting in the following reporting periods. Measures to reduce gender pay gaps contribute to fairness and equality within the company.
Key figures for health and safety (S1‐14)
Concepts, measures and key figures
Biotest AG ensures a high level of occupational health and safety for its employees. This includes:
- Ergonomic workplace design to reduce physical stress.
- Preventive health measures, including mental and physical health programmes.
- Regular training and safety instruction, which is mandatory for all employees. Regular training for medical personnel on topics such as infection control, ergonomics and psychosocial stress management.
- Provision of personal protective equipment (PPE) that is tailored to the special requirements of working in biomedical envi‐ ronments.
- Involving employees in safety concepts through workshops and feedback mechanisms.
Secure employment and long‐term job security:
Long‐term job security is a strategic goal at Biotest and is supported by targeted personnel development and qualification programmes.
45 All information relates to the Biotest Group.
46 In accordance with Delegated Regulation (EU) 2023/2772, the basic salary, other fixed allowances and any other remuneration, in cash or in kind, received directly or indirectly by the employee ('additional or variable components') have been taken into account in the calculation of the average salary. As a result, the financial year 2024 is not comparable with previous years when 100% of the fixed salary was taken into account.
- Regular risk assessments and emergency procedures promote the physical and mental well‐being of employees in the long term.
- Ongoing monitoring of workload, including mechanisms for monitoring overtime, is used to minimise health risks
Future measures for 2025:
- Introduction of a digital health platform to promote individual health programmes, stress management and physical activity.
- Carrying out a mental risk assessment at the Dreieich production site to identify mental stress and derive targeted improve‐ ment measures.
- Employee involvement in health and safety processes through feedback mechanisms and workshops.
Biotest has established a structured monitoring process to continuously review the effectiveness of occupational safety and health pro‐ motion measures:
Collection and analysis of safety data:
- Ongoing recording of accident rates, first‐aid incidents and days of absence due to work‐related injuries.
- Annual reporting and trend analysis to identify risk areas.
Risk assessment and prevention:
- Conducting regular risk assessments at the Dreieich production site to identify potential safety risks.
- Deriving targeted measures to reduce work‐related injuries, e.g. through technical improvements or optimized work pro‐ cesses.
Internal and external audits:
- Regular internal checks of safety standards by the occupational safety team.
- Planning of external certification of occupational safety management in 2025.
Feedback mechanisms:
Introduction of a digital security incident reporting system to enable faster response to potential threats and to involve stake‐ holders directly in the improvement process.
Reporting and Continuous Improvement:
- Regular reporting to the Board of Directors on the safety situation and possible improvements.
- Ongoing adaptation of health and safety strategies based on data collected and feedback from employees.
Expected results:
- Sustainable improvement of the physical and mental health of the workforce.
- Reduce sickness absence through preventive health measures.
- Increase job security and job satisfaction, especially in production.
- Strengthen employee retention through targeted training and qualification programmes to secure long‐term employment.
Our responsibility for health and safety
The safety of our people is our top priority. The responsibility for the health and safety of employeeslies with the Board of Management of Biotest AG. The implementation of the concepts and measures lies with the Occupational Safety Department. In 2024, the health and safety of our german employees will be proactively and preventively managed beyond the legal requirements. A certified occupational health and safety management system is not currently in place, but is planned for 2025.
According to the current reporting procedures, 133 first aid entries and occupational accidents with and without lost days were reported internally. However, of these, there were no deaths, no serious work‐related illnesses, 21 reportable occupational accidents and 13 reportable commuting accidents to the employers' liability insurance association. Four employees of external service providers were reported to have suffered work‐related accidents. Every work‐related accident with lost time >1 day is investigated, and appropriate measures are defined. The report is distributed to managers as brief information.
For the entire Biotest AG group, including plasma centresin the Czech Republic and Hungary, the rate ofreported occupational accidents with days lost, in relation to 1,000,000 working hours, was 11.84. The total number of days lost due to occupational accidents was 632.
Prevention and training
As part of our programme to improve occupational safety, we have provided comprehensive training for all employees. The aim is to reduce the accident rate to a minimum until 2029. Our measures include regular workplace inspections, investments in safer working environments and the introduction of a digital system for reporting accidents. Methods to achieve the objective include, as described above, the analysis of safety figures, hazard analysis and others.
Remedial action and complaints mechanism– Concepts, measures and key figures
Biotest AG has established a transparent procedure that allows employees to anonymously express concerns. This includes the whis‐ tleblower system and a telephone hotline. These are provided on the Biotest AG websites. These channels are regularly monitored to ensure their effectiveness. In the event of a reported GOV‐1 violation or compliance incident, Biotest AG implements targeted measures to remedy the situation. This includes the investigation and evaluation of each report received. This is reviewed by an inde‐ pendent compliance team to objectively assess the facts and risks. Depending on the severity of the violation, disciplinary action, train‐ ing or structural adjustments may be taken. The implementation of the measures is continuously monitored to ensure that problems are resolved in the long term and similar incidents are avoided. Key findings and measures are regularly reported to the Board of Man‐ agement and, where appropriate, relevant supervisory bodies. Further detailed information on the protection of whistleblowers can be found in the sustainability declaration in chapter G1 Information on corporate governance – Corporate policy objectives.
Incidents, complaints and serious impacts related to human rights (S1‐17)
No serious human rights incidents were reported in 2024. A total of 9 complaints were received through our whistleblower system and investigated by Internal Audit with support from the Compliance team. This included 2 incidents of discrimination which were investi‐ gated and remedied. No fines, sanctions or compensation were paid or imposed during the reporting period (€0)
Equal opportunities, diversity and inclusion– Concepts, measures and key figures
Inclusion and equal opportunities policies: Through inclusion and equal opportunity measures, Biotest strengthens a diverse workforce and ensures fair career opportunities for all employees.
Women in management positions or aspiring to such positions, as well as marginalised groups that have been underrepresented in management positions to date, benefit from targeted support, in particular through newly introduced mentoring programmes aimed at reducing structural barriers and promoting diversity. The goal is to increase the proportion of women in management positions through targeted support.
Mentoring programme and advancement of women
Measures: Launch of an external mentoring programme in November 2024 with 17 participants to prepare women for leadership roles or to develop them in their leadership roles.
Next steps for 2025:
- Introduction of an additional internal mentoring programme in January 2025, which is open to all employees of Biotest AG.
- Scaling of both mentoring programmes to include at least a further 50 female participants.
- Introduction of an evaluation process to assess the effectiveness of the programme.
- Expansion of career opportunities through internal talent programmes to identify potential leaders from the workforce and promote flexible career paths, particularly for women and marginalised groups. There are no plans to introduce a career development policy.
Targets:
Women on the Supervisory Board: The Supervisory Board of Biotest AG consists of six members, four of whom are shareholder repre‐ sentatives and two employee representatives. No woman has been elected to the Supervisory Board as a shareholder representative. The two employee representatives are men. This means that the target of 30% women has not been met.
Women on the Board of Management: The proportion of women on the Board of Management was originally 33%. Following the reduc‐ tion of the Board of Management to two members and the appointment of Mr Martin Möller on 1 September 2024, there are no longer any women on the Board of Management. The target of 33% women was therefore not achieved.
Women in senior and top management positions: The Board of Management of Biotest AG has set itself a target of 30% for the partici‐ pation of women at the first management level by 1 January 2025, which it has already exceeded with 30.8% by 31 December 2023. The target for the second management level was set at 30% by 1 January 2025 and the proportion of women at this management level was 31% by 31 December 2024. The proportion of women in the Biotest Group (1,397 female employees) was 52.4% on 31 December 2024.
Monitoring and measuring progress:
- Collection of data on the number of promotions resulting from the mentoring programme.
- Annual recording of the proportion of women in management positions and comparison with targets.
- Evaluation of the satisfaction and effectiveness of the programme through regular surveys among participants.
With these measures, Biotest AG aims to increase the proportion of women in management positions compared with the baseline year 2020 and to promote equal opportunities and diversity in the long‐term. In addition, internal succession planning is to be ensured through targeted talent development. Specific stakeholder involvement is planned for the coming years.
Education and training
Concepts, measures and key figures
The introduction of training and development programmes enables continuous skills development in all areas. Digital learning platforms and practice‐oriented training offer individual development opportunities. Biotest pursues a sustainable human resources strategy that focuses on long‐term employee retention,skills development and innovation. New workplace models(flexible working hours and mobile working) and targeted training initiatives are designed to ensure the future viability of the workforce. The Board of Management of Biotest AG bears overall responsibility for further training opportunities and the employability of employees. The Human Resources department is responsible for implementing the concepts and measures.
Action: Introduction of a revised competency model in November 2024 with a stronger focus on diversity, equality and inclusion (DE&I) and modern leadership practices at Biotest AG.
Next steps for 2025:
- Integration of the competency model into induction plans for new employees.
- Introduction of a 360‐degree feedback tool to promote a unified leadership culture.
- Management training to embed DE&I aspects at all executive levels.
- Step‐by‐step implementation and training of the competency model and relevant personnel development tools in foreign subsidiaries.
- Establishment of a monitoring mechanism through regular town hall meetings and information events
- Implementation of a modern format for dialogue between senior management and employees.
Biotest uses various mechanisms to track the effectiveness of training and professional development measures and to ensure their success in terms of the employability of the workforce. For example, participation rates in internal and external training are measured. In addition, an evaluation of internal development opportunities can be derived from the turnover rates within the company, particularly in management positions.
These measures are designed to ensure the promotion of a consistent leadership culture acrossthe Group, to build trust and to promote diversity within the workforce. The success of these measures will be measured in the medium term through internal promotion rates and feedback mechanisms. For subsequent reporting years, the introduction of quantitative indicators will be considered.
Long‐term review of the success of the measures based on internal promotion rates and feedback mechanisms.
Training and development
Biotest AG offers a variety of training and development programmes to support the professional development of its employees. These range from internal training to external professional development supported by digital learning platforms. The training is designed to provide employees with the skills they need for their current and future roles, particularly with regard to digitalisation, process optimi‐ sation and leadership.
Targets: Strengthen the digital literacy of the workforce and promote continuous learning. Transform to a culture of continuous im‐ provement through targeted process improvement training. Enhance leadership skills with a particular focus on manufacturing and technology‐enabled work processes.
Measures:
- Implementation of 'White Belt' training courses for process optimisation with 70 trained employees and 11 certifications
- Interviews with production managers to identify specific training needs.
- Implementation of digital training platforms to enable flexible and location‐independent training.
Next steps for 2025:
- Extend twice‐monthly White Belt training sessions to at least another 100 employees (baseline 2024). Each training session covers 10‐20 employees. The individual training sessions will be followed by a more advanced training programme (Yellow Belt training) from 2025.
- Introduce a modular training programme for frontline managers to provide targeted and needs‐based training.
- Establish an AI committee to prepare the company for automation and the use of AI technologies.
- Expanding the mentoring programme to support junior managers.
Biotest AG expects targeted measures to bring significant improvements in various areas. Management skills are to be strengthened through structured and needs‐based training programmes, which will also optimise processes within the company. At the same time, the digital skills of the workforce will be expanded in a targeted manner in order to successfully meet the growing challenges of the digital transformation. Another key objective isto promote a living learning culture that firmly anchors continuoustraining and individual development in everyday working life. In addition, a well‐trained and adaptable workforce contributes significantly to increasing inno‐ vative strength and thus ensures the long‐term competitiveness of the company. The introduction of quantifiable targets for the above objectives is under consideration, as is the increased involvement of internal and external stakeholders.
These measures can help to ensure that training not only promotes the individual development of Biotest AG employees, but also ad‐ dresses and minimises the company's strategic risks:
Skills shortage: Long‐term competence development and talent promotion reduce the risk of a shortage of qualified employees.
Technological change: Training in the area of digitization and process automation minimizes the risk of a lack of technological skills in the workforce.
Health and safety: Training in ergonomic workplace design and stress management helps to reduce absenteeism due to illness.
Diversity and inclusion: Management training on DE&I topics promotes an open corporate culture and reduces the risk of G1‐1 or disad‐ vantage.
Procedures for involving the company's employees and their representatives with regard to impacts (S1‐2)
Concepts, measures and key figures
The company has a comprehensive approach to employee engagement based on transparency regular communication and active in‐ volvement of relevant stakeholders. There is a focus on diversity to ensure equal opportunities and promote a diverse culture.
Organisation and structure of the integration
Biotest employs 99.9% of its employees in countries within the European Economic Area (EEA) and a small number of employees in Switzerland. While employees in the EEA benefit from comprehensive legal requirements regarding minimum wages, labour standards and human rights protection, employees in Switzerland are subject to local labour regulations. Switzerland is not a member of the EEA, but through bilateral agreements with the EU, it has a high level of labour and socialstandardsthat also ensure the rights and protection of employees.
For Biotest AG, the main site and largest division of the company, the works councils and the senior management speakers' committee are key players. Ongoing dialogue between the Board of Management, the Works Councils and relevant functional areassuch as Human Resources or IT with the Works Council ensuresthat the concerns of the workforce are fully taken into account. Regular meetings provide a platform for informing employees about developments, discussing feedback and developing joint solutions.
In foreign subsidiaries, including the Swiss subsidiary, local management and site managers involve the workforce. They coordinate communication and implement measures resulting from global corporate decisions.
Regular quarterly Town Hall meetings, organised by the Executive Committee, serve as a transparent information and exchange plat‐ form for all companies. They ensure that employees have the opportunity to follow current developments and contribute their per‐ spectives. The use of complaint mechanisms or feedback systems (e.g. Ask the Management) ensures that employees are actively in‐ volved in strategic decision‐making. It is not uncommon for employee feedback, submitted through the company's feedback systems, to result in specific agreements. One such agreement, for instance, could involve the implementation of a recycling program for table‐ ware and the introduction of a deposit system at the company cafeteria.
Data Protection for Employees – Concepts, measures, key figures
Relevance and Objectives
Biotest AG recognizes that the protection of personal data of both female and male employees is essential to maintaining their trust and complying with regulatory requirements. In accordance with the General Data Protection Regulation (GDPR), Biotest has imple‐ mented robust data protection measures. These ensure the confidentiality, integrity, and availability of sensitive employee and donor data.
Identification of impacts, risks and opportunities
Negative impacts:
A negative impact on employees' personal data can have significant consequences, including financial risks such as identity theft and fraud. It can also cause significant psychological distress and anxiety for those affected. Potential consequences also include reputational damage and long‐term personal impact.
Risks:
Potential financial and legal consequences, such as fines, penalties, sanctions or remediation costs, that may result from violating employees' privacy rights pose a risk.
Measures and monitoring mechanisms
Biotest AG uses a combination of technical and organisational measures as well as comprehensive monitoring mechanisms to protect personal data.
Technical measures ensure a high level of security by encrypting all personal data during transmission and storage. State‐of‐the‐art firewalls and intrusion detection systems (IDS) as well as regular security updates help to detect and avert cyber attacks at an early stage. In addition, secure backups and disaster recovery plans ensure that data can be accessed quickly and safely in the event of a system failure.
These technical precautions are complemented by organisational measures. Since 2018, the company has had a Data Protection Of‐ ficer. This role reports directly to the Board of Management and monitors compliance with all relevant regulations. To raise awareness of data protection and IT security, employees receive regular training, particularly with regard to risks such as social engineering and phishing attacks. In addition, data access policies follow the need‐to‐know principle to prevent unauthorised access. Regular data pro‐ tection reviews and audits ensure that all requirements are met and that potential vulnerabilities are identified at an early stage.
Monitoring and audits
- Regular internal and external data protection audits to verify compliance with data protection and security
- Monitoring of data protection violations and IT security incidents by means of a continuous monitoring
- Evaluation of the effectiveness of data protection measures using key performance indicators (KPIs) to enable adjustments to be made at an early stage.
Key figures and targets
Quantifiable targets for continuous data protection improvement are being developed.
Donors /Entitiy‐Specific
Identification of significant impacts, risks and opportunities (IROs)
Biotest AG identifies significant impacts, risks and opportunities (IROs) with regard to health and safety protection and data protection under the ESRS S1 standard. This also applies to donors, who will be considered in more detail below as a company‐specific topic:
Biotest AG is a leading global company in the sector of plasma proteins and biotherapeutics. The voluntary donation of plasma is the basis for the production of high‐quality medications for the treatment of immune deficiencies, coagulation disorders and other serious illnesses.
Biotest AG is committed to safeguarding the health, safety and satisfaction of donors and employees in the value chain. This is achieved through strict quality and safety standards in all phases of plasma donation. The topic is not included in the incentive systems for remuneration.
Management of impacts, risks and opportunities
Impacts, risks and opportunities related to own workforce ESRS 2 SBM‐3
As part of the materiality analysis carried out by Biotest AG, the issues of donor health and safety and data protection were included in the analysis using benchmark analyses and identified as particularly material.
Negative impacts
Negative impact due to potential risk of infection for plasma donors. Long‐term health problems can affect the quality of life of donors and lead to lasting negative effects. In the worst case, there could be deaths caused by the activity.
A serious data breach resulting in the loss or theft of sensitive donor information could have a negative impact on the donors affected. This could permanently damage donor confidence and reduce the number of voluntary donors.
The negative impact of potential infectious risks to plasma donors can lead to long‐term health problems affecting quality of life and, in the worst case, death. A serious data breach involving the loss of sensitive donor information could permanently damage confidence and reduce the number of voluntary donors. In the short term, there is a risk of reputational damage and initial legal consequences, while in the medium term there is an increasing risk of liability and a decline in donations. In the long term, stricter regulatory require‐ ments, litigation and lasting reputational damage could affect business operations. Financial consequences include fines, compensation payments, lost sales and increased investment in data protection and security measures.
Health and safety of donors
Haemovigilance concept47 of Biotest AG
The haemovigilance concept of Biotest AG includes the systematic monitoring of the entire plasma donation process as well as the tracking and analysis of adverse events. The aim is to identify risks for donors at an early stage, to ensure continuous improvements in processes and to meet regulatory requirements.
Targets:
- Donor safety: Ensuring a risk‐free donation process by identifying and avoiding complications or side effects.
- Early warning system: Early detection of potential systemic problems in the donation process that could affect the health of donors or the quality of plasma.
- Quality management: Continuous improvement of plasma collection and processing procedures based on the findings from haemovigilance.
- Transparency: Building trust through transparent communication with donors about safety and quality assurance measures.
Elements of the haemovigilance programme:
- Systematic data collection: Documentation of all adverse events in a central database for early detection of potential risks.
- Analysis and root cause analysis: Identification of patterns and causes of adverse events to derive targeted countermeasures.
- Risk management: Development of preventive measures based on the identified risks. Implementation of safety measures, such as improved donor protocols, training and continuing education of personnel or optimisation of donation equipment.
- Reporting: The PEI prepares an annual haemovigilance report with qualitative and quantitative data on incidents and actions. Biotest is required to report all incidents at the plasma collection centres to the PEI.
- Feedback mechanism: Integrate donor feedback to optimise processes and ensure continuous improvement (KPI: donor sat‐ isfaction through surveys, target not yet set).
Preventive measures for donor safety
- Pre‐donation medical evaluation: Each donor is medically examined before donating to rule out health risks.
- Adherence to international standards: Use of disposable materials and strict hygiene protocols to minimise the risk of infec‐ tion.
- Emergency preparedness: Training ofstaff at the donation centres to respond quickly and effectively to medical emergencies.
Training and awareness‐raising
- Regular training of medical personnel on haemovigilance topics, including risk identification and the management of adverse events.
- Implementation of a digital training system that provides up‐to‐date best practices and ensures that all employees are up to date with the latest haemovigilance requirements.
Monitoring and KPIs
For future reporting years, specific KPIs will be developed to monitor and track progress, which will be defined for subsequent financial years. These should relate to the frequency of adverse events (monitoring the number and severity of incidents in the donation process) and the assessment of satisfaction through regular surveys and feedback on the quality of the donation process.
Responsibilities
The medical directors of the donation centres are responsible for the haemovigilance management of Biotest AG Dreieich. They work closely with the Quality Assurance and Regulatory Affairs departments, as well as with the relevant management bodies, to ensure continuous monitoring and optimisation of processes in accordance with regulatory requirements. The haemovigilance targets are not part of the remuneration incentive systems.
Main responsibilities include:
- Monitoring and analysing adverse events and deriving and implementing preventive measures.
- Regular reporting to the board and relevant regulatory bodies on identified risks, trends and measures taken.
- Coordination with external authorities and auditors to ensure compliance with regulatory requirements, including EMA and FDA guidelines and ESRS requirements.
- Integration of donor feedback to optimise the plasma donation process.
All identified risks and measures are documented in an annual haemovigilance report of PEI and evaluated at board level.
Time frames, financial resources and results of the measures
The implementation and continuous improvement of haemovigilance measures will take place over a period of 3‐5 years. During this time, new safety standards will be progressively implemented, training programmes expanded and risk prevention processes optimised.
Financial resources
Biotest AG Dreieich provides a fixed annual budget for the implementation and continuous improvement of haemovigilance measures. More specific information on the allocation of the budget is not yet collected for reporting purposes. The budget is used for education and training of medical personnel and for safety measures and personal protective equipment (PPE) for employees in plasma donation centres.
Results of the measures
The effectiveness of haemovigilance measures is ensured through regular evaluations. The results are included in non‐public transpar‐ ency reports submitted to the Paul Ehrlich Institute.
Data protection for donors
Biotest AG recognises that protecting the personal data of donors is essential to maintain their trust and to meet regulatory require‐ ments. In accordance with the General Data Protection Regulation (GDPR) and other international standards, Biotest has implemented robust data protection measures. These ensure the confidentiality, integrity and availability of sensitive donor data. The concepts, measures and targets for data protection for employees described under S1 apply equally to donors' data and are also applied to them.
F.III.2 S4 CONSUMERS AND END USERS
Impacts, risks and opportunities and their interaction with the strategy and business model (SBM‐3)
The health and safety of patients is our number one priority. Our products are developed, manufactured and tested in accordance with EU Good Manufacturing Practice (EU GMP) requirements. GMP is not only a regulatory requirement but also a key part of our strategic responsibility to consumers and end users. Our GMP system includes a comprehensive quality management system, validation of critical manufacturing processes, continuous training of our specialist personnel and detailed traceability of all manufacturing steps. We also conduct regular internal audits and undergo external inspections by national and international regulatory authorities (e.g. EMA, FDA). In the year under review, we successfully passed all audits and had no recalls for quality or safety reasons. Our continuous process improvements reduce the risk of adverse events and actively contribute to patient safety and confidence in our products.
As a leading provider of biotherapeutic drugs derived from human plasma, Biotest AG recognises the safety and efficacy of its products and the protection of patient data as key issues in its dealings with consumers and end users (patients). This commitment is firmly integrated into the corporate strategy and implemented through strict quality and safety standards. As Biotest operates in a highly regulated pharmaceutical environment, current legal requirements must be fully complied with. The quality of each product batch must be individually demonstrated to the Paul Ehrlich Institute and is individually released.
In its business strategy, Biotest takes into account both risks and opportunities arising from the impact and dependency on patients. Security ofsupply, data protection violations, quality defects or regulatory changes could affect the confidence of end users and increase business risks. These issues are therefore continuously integrated into the business strategy.
The opportunities identified as material are related to the corporate strategy as follows: Biotest can strengthen its market position and make a positive contribution to patient care through innovative therapies, improved patientservices and the development ofsustainable supply chains.
These risks and opportunities are directly incorporated into strategic planning and the business model. Product development focuses on safe, effective and sustainable medicines. Data security and transparency are ensured through strict data protection measures and clear communication, and patient involvement is achieved through increased dialogue with patient groupsto improve security ofsupply.
Strategies related to patients Biotest pursues the following strategies to manage significant impacts, risks and opportunities related to consumers:
- Product safety: Strict compliance with GMP standards and ongoing pharmacovigilance. Cases of non‐compliance with inter‐ national guidelines in the downstream value chain: Biotest is committed to complying with the United Nations Guiding Prin‐ ciples on Business and Human Rights, the ILO Declaration on Fundamental Principles and Rights at Work and the OECD Guide‐ lines for Multinational Enterprises. No cases of non‐compliance with these standards were reported during the reporting period. Failure to comply with these standards could lead to a deterioration of working conditions in the company and thus jeopardise quality and product safety.
- Transparent communication: Providing detailed information on product use and safety.
- Social inclusion: Working with patient organisations and foundations such as the Haemophilia Foundation to promote access to vital therapies.
- Safety of plasma collection: Supporting donors with the highest safety standards and regular health checks.
Stakeholder interests and perspectives (SBM‐2)
The patients of Biotest AG are primarily individuals suffering from rare and often life‐threatening diseases in the fields of immunology, haematology and intensive care. The main groups include:
- Patients with primary or secondary immunodeficiencies: These patients rely on immunoglobulin therapies to prevent infec‐ tions and stabilise the immune system.
- People with haemophilia and other blood coagulation disorders: Biotest offers special plasma protein products that improve blood coagulation and prevent life‐threatening bleeding.
- Patientsin intensive care units or with severe autoimmune diseases: Biotest products are also used in the treatment ofsevere inflammatory diseases and organ failure to specifically modulate the immune system.
- Vulnerable groups, including paediatric and geriatric patients: Children and the elderly are particularly vulnerable patient groups who require a continuous supply of safe and effective medicines.
These patient groups have specific needs, including guaranteed access to life‐saving medicines, the highest quality standards, transpar‐ ent information on side effects and ongoing medical support.
Concepts related to consumers and end users (S4‐1)
Health protection and product safety for patients
Strategic relevance and targets
Patient safety is at the core of Biotest AG's sustainability strategy. The primary objective is to ensure maximum product safety through continuous monitoring and preventive measures.Biotest AG's pharmacovigilance programmes represent a significant role in minimising adverse effects and risks, and ensuring the efficacy of our drugs. The measures for pharmacovigilance are subject to a constant, contin‐ uous improvement process that continuously provides for necessary adjustments to existing measures (GxP, GMP).
All processes, from plasma collection to production, are carried out to strict quality and safety standards.
Responsibilities within the company
Responsibility for product safety, pharmacovigilance and the well‐being of patients lies at several levels within Biotest AG:
- Board of Management level: Oversight and strategic direction of pharmacovigilance and safety programmes.
- Quality and Safety Management: Implementation of GMP standards and continuous improvement of safety measures.
- Pharmacovigilance department: Analysis and reporting of adverse drug reactions (ADRs) and continuous assessment of prod‐ uct safety.
Regulatory Affairs department: Ensuring compliance with regulatory requirements and monitoring changes in regulatory re‐ quirements.
Material impacts, risks and opportunities
Negative impacts
- Lack of feedback could reduce product satisfaction and affect the effectiveness of the drug.
- Restricted access to important product information about Biotest products could make patient education more difficult.
- Non‐compliance with GMP standards could compromise drug safety.
- Loss of sensitive health data could lead to stigmatisation, identity theft or blackmail.
- Data breaches could undermine patient confidence and allow misuse of personal data.
- Restrictions on freedom of expression could have a negative impact on product quality and patient safety.
The identified negative effects of Biotest AG on consumers and end users are both systemic (e.g. potential data protection breaches or regulatory changes affecting several patient groups) and individual (e.g. quality defects in a single product). This is regularly reviewed as part of the pharmacovigilance process.
Positive impacts
- Increasing the life expectancy of the population by developing new products that can help cure diseases.
- Promoting accessibility to medical treatments by participating in accessibility programmes.
Opportunities
- Development of new market segments by developing products for previously unaddressed patient groups.
- Innovation in product development to improve therapies for underserved patient groups.
- Responsible business practices and transparent policies that contribute to consumer trust, knowledge and confidence.
Procedures for consumer and end‐user involvement in relation to impacts (S4‐2)
Patients` perspectives are actively incorporated:
- Regular dialogue with patient organisations and professional associations: Biotest works closely with patient organisations and professional associations to support their health promotion efforts. The company values ethical and transparent cooper‐ ation, always respecting the independence of the organisations. This commitment includes financial support as well as organ‐ isational support in the day‐to‐day work of the organisations. Involvement takes place through different specialist depart‐ ments and in different ways with different organisations.
- Integration of complaints into corporate strategy through the positions of VP Regulatory Affairs, Information Officer and VP Commercial Operations: Through continuous dialogue with patient organisations, Biotest gains valuable insights into the ex‐ periences and needs of patients. This complaint flows directly into the development and improvement of products and the design of services to ensure patient‐centred care.
- Supporting the Haemophilia Foundation to better understand the interests and needs of patients.
- Establishment of a portal for reporting adverse reactions and product safety concerns: Biotest AG has implemented a struc‐ tured process to collect and process suspected cases of adverse reactions and product safety concerns. This system allows both patients and healthcare professionals to report adverse events, with the protection of personal data being given the highest priority. Reports of adverse reactions can be sent directly to Biotest AG. Contact details can be found on the company's website. Personal data of patients and reporters will only be forwarded to Biotest AG in anonymised form. Contact details will only be used to confirm receipt of the report and to clarify any uncertainties.
These measures ensure that the perspectives of patients are incorporated into the decision‐making process and continuously improved. It is vital to promote positive impacts through targeted dialogue with patient organisations. This will enable the early identification of
needs and their integration into product developments, and the development of new forms of treatment to improve quality of life. Transparency can be increased through improved communication about modes of action and side effects. Stakeholder engagement is ongoing, enabling constant feedback on side effects and concerns, and continuous dialogue with patient associations.
Measures taken to address material impacts on consumers and end‐users and approaches to managing material risks and opportunities related to consumers and end‐users, and the effectiveness of these measures (S4‐4)
Actions to promote access to medical treatmentCompassionate Use Programme to allow medical prescriptions for unauthorised med‐ icines in France:
- Provision of medicines for individual patients where there are no alternative treatment options.
- Expected outcome: Improved outcomes for patients with rare or difficult‐to‐treat diseases.
- Activities: Manufacture, distribution and provision of medicines to patients in need.
- Geographical scope: Focus on regions with limited access to innovative therapies.
- Stakeholders involved: Patients and local distributors.
In the medium term, the 'Compassionate Use Programme' is to be expanded as far as possible to include further countries and thera‐ peutic areas and to optimise logistical processes (2026‐2028).
Procedures for improving negative impacts and channels through which consumers and end‐users can express concerns (S4‐3)
Measures to ensure product safety and efficacy
Biotest AG, based in Dreieich, Germany, is committed to maintaining the highest quality and safety standards in the manufacture of of biological drugs derived from human plasma. All manufacturing processes are carried out in accordance with Good Manufacturing Prac‐ tices (GMP) to ensure the safety and efficacy of the products.
Good Manufacturing Practices (GMP): GMP include guidelines to ensure that products are consistently manufactured and controlled according to quality standards. At Biotest, these practices include (conclusion: ongoing, continuous monitoring)
- Purity requirements: Use of high quality raw materials and strict controls throughout the manufacturing process.
- Hygiene standards: Adherence to strict hygiene protocols to prevent contamination.
- Production validation: Ensuring that all production processes are reproducible and reliable.
- Traceability: Complete documentation to trace each product back to its source.
These measures address risks such as contamination, quality defects and risks to patient safety. The effectiveness of these measures is verified by ongoing internal and external audits for compliance with GMP guidelines.
Biotest also undergoes regular audits by various national and international authorities to ensure compliance with GMP and other rele‐ vant standards. The auditing organisations include
- Paul Ehrlich Institute (PEI): German Federal Institute for Vaccines and Biomedicines
- European Medicines Agency (EMA): European Union Agency for the Evaluation and Supervision of Medicinal Products
- US Food and Drug Administration (FDA): United States agency responsible for food safety and drug approval.
- Internal quality control teams: Biotest also carries out its own audits to ensure continuous improvement.
Improved protection against counterfeiting and greater product safety for consumers are expected following the introduction of a tam‐ per‐evident packaging design for all medicines to prevent counterfeiting and increase patient safety.
Pharmacovigilance programmes: Biotest operates comprehensive pharmacovigilance programmes to monitor the safety of its products after they have been launched. These include:
- Systematic recording and assessment of adverse effects by a global pharmacovigilance team for early identification of poten‐ tial risks. (Completion: ongoing, annual evaluation)
- Implementation of a standardised reporting system for adverse drug reactions (ADRs) to optimise data analysis and response times. (Completion: Q4 2025)
- o Expected results: Improvement in reporting rates, faster processing and reduction in medication risks.
- o Corrective actions: Early resolution of safety issues through product information changes or recalls
- o Monitoring effectiveness: Regular assessment using KPIs to measure speed of response and number of cases suc‐ cessfully resolved.
- Regular audits to ensure compliance with international standards (e.g. ICH E2E) and continuous process improvement. (Clo‐ sure: Annual, next review in Q2 2024)
- o Expected results: higher compliance rate, optimised pharmacovigilance processes.
- o Audits by: Paul Ehrlich Institute (PEI), European Medicines Agency (EMA), US Food and Drug Administration (FDA), internal quality control teams.
Biotest AG is committed to respecting human rights both within the company and along the supply chain. In its policy statement on the Supply Chain Due Diligence Act, Biotest emphasises compliance with human rights and environmental due diligence. In the event of violations, established risk monitoring and risk elimination processes are activated to implement effective remedial measures: Biotest has a complaints mechanism in place for consumers and patients. Adverse effects or violations can be reported by consumers and pa‐ tients using this mechanism. These incidents are reviewed and processed by an independent pharmacovigilance committee for risk assessment. If human rights are violated (e.g. due to adverse effects or restricted access), corrective action is taken, including product adaptations, regulatory reporting or expanded training for healthcare professionals.
Biotest AG has implemented mechanisms to record and report serious human rights issues and incidents. Employees and external part‐ ners can report potential misconduct through defined channels (whistleblower system, local compliance officers, corporate compliance office, email addressfor Environmental Health and Safety, phone number on the website, etc.), with the protection ofthe whistleblowers being ensured. Serious cases are recorded, documented and analysed. During the reporting period, no serious human rights incidents were reported by patients or consumers. Detailed information on the options available to whistleblowers can be found in the sustaina‐ bility declaration in the section Information on Corporate Policy G1 – Corporate Policy Objectives.
These comprehensive measures ensure that Biotest AG's products meet the highest quality and safety standards, while also complying with ethical and human rights obligations.
Targets related to addressing significant negative impacts, promoting positive impacts and managing significant risks and opportunities (S4‐5)
Although specific measurable patientsafety targets are being developed forthe first time forthe 2025 reporting period, Biotest is already monitoring the effectiveness of its concepts and measures to sustainably improve patient safety. In addition to the mechanisms for whistleblower protection and the underlying systems described above, there are specific complaints mechanisms for patients and med‐ ical professionals to submit complaints or concerns related to the company's products. These include a central point of contact for medical and scientific information and product feedback, an established procedure for reporting adverse drug reactions (pharmacovig‐ ilance as described above) via the website, by email or telephone, and various options for contacting corporate communications via social media, quality management or customer service. These mechanisms are regularly reviewed and are part of the company‐wide system for product responsibility and patient safety.
Follow‐up procedure:
- Regular internal audits and external reviews to ensure compliance with regulatory requirements (e.g. by the Paul Ehrlich In‐ stitute, EMA, FDA).
- Analysis of pharmacovigilance data to identify potential safety risks and the effectiveness of corrective measures.
Reporting mechanisms to continuously evaluate the effects of measures on patient safety.
Indicators for monitoring progress:
Improvements are continually incorporated into the GMP protocols based on a continuous improvement process.
Quantifiable indicators are currently being developed..
Data protection for patients
Strategic relevance and targets
Ensuring the protection of personal data is of the essential importance to maintain the trust of patients in Biotest AG and to comply with regulatory requirements, in particular the DSGVO. Biotest pursues a comprehensive approach that includes both technical and organi‐ sational measures to prevent data protection violations. Responsibility for data protection lies at the highest level with the management of Biotest AG. The Data Protection Officer reports directly to the Board of Management and regularly reports on data protection measures, particularly with regard to patient and consumer data.
Material impacts, risks and opportunities (SBM‐3.10)
In the materiality analysis, Biotest AG has defined the following negative effects and risks with regard to data protection in connection with S4 end users and users (patients) as material (no opportunities identified):
Negative impacts
- Data loss and identity theft: A serious data breach could result in the loss or theft of sensitive health information, which could lead to stigma, identity theft or blackmail.
- Loss of trust: Inadequate data security could cause lasting damage to patient confidence.
Risks
Reputational and financial risks: Failure to comply with privacy policies could result in regulatory sanctions and economic damage.
Measures to avoid negative impacts
Data use and data protection
- Minimisation of data collection: Collection of only the necessary patient data while maintaining data economy.
- GDPR‐compliant processing: Use of modern security standards to ensure legally compliant data processing.
- Technical protective measures: Data encryption, firewalls, real‐time monitoring.
Measures and Monitoring
Technical measures:
- o Encryption of all personal data (storage and transmission) is standardised across the company.
- o Advanced firewalls are in place, as well as real‐time monitoring systems to detect suspicious activity.
- o Regular penetration tests are conducted to identify and remediate vulnerabilities.
Organisational measures:
- o Employee awareness through annual data protection training.
- o A Data Protection Officer has been appointed and reports regularly to senior management.
o Data storage: Personal data will only be kept for as long as necessary for public health reasons and as required by applicable law, but for at least ten years after the product's authorisation has expired.
Targets and progress
Biotest AG is committed to continuous improvement in data security. Specific targets will be developed in the future as part of sustain‐ ability reporting, and time horizons will be defined, along with the financial resources required to achieve the targets. The primary focus will be on enhancing data security through sustainable investments, optimising response times to data protection violations, expanding training programmes to raise awareness of data protection, and conducting regular audits of data protection measures by both external and internal auditors.
F.IV. CORPORATE GOVERNANCE INFORMATION
F.IV.1 G1 CORPORATE POLICY
Corporate policy and governance structure
Biotest AG pursues a comprehensive corporate policy that covers key topics such as corporate culture, whistleblower protection, sup‐ plier management and the prevention of corruption and bribery. These aspects are closely linked to the company'ssustainability strategy and business model and contribute to the implementation of ESG (environmental, social, governance) objectives. They ensure respon‐ sible business practices along the value chain and strengthen Biotest Group's resilience to external risks.
The company's corporate policy encompasses pivotalstrategies for cultivating a sustainable corporate culture, fortifying compliance and integrity, and implementing efficacious risk management. The subjects of corporate culture, corruption prevention, cybersecurity and sustainable supplier management have been identified as being of particular significance within the domain of corporate policyThis corporate strategy is implemented across the entire value chain, from plasma collection to production and distribution, with a geo‐ graphic focus on Europe. The affected interest groups are, above all, employees, suppliers, investors, patients and public authorities.
The role of the administrative, management and supervisory bodies in relation to corporate policy (GOV‐1)
Biotest AG has a dual management system, with the Board of Management responsible for managing the company and the Supervisory Board for monitoring it. The Board of Management is responsible for managing the Company. In doing so, it is bound by the interests of the company and is committed to increasing the value of the company in the interests of sustainable development. It develops the company's strategy, agrees it with the Supervisory Board and ensures its implementation. The Board of Management also ensures that the Supervisory Board receives regular reports on progress and actions.
The Supervisory Board monitors compliance with company policy, reviews strategy and provides impetus for its further development. It ensures that compliance and governance standards are met and that sustainable business practices are implemented.
The governing bodies of Biotest AG possess extensive expertise in areas such as corruption prevention and good corporate governance. Regular training, expert dialogues and benchmarking strengthen competencies. These training measures ensure that the management and supervisory bodies remain informed about current regulatory developments and best practices, and that value‐oriented corporate governance is maintained.
Material impacts, risks and opportunities
Biotest AG's corporate policy considers significant impacts, risks and opportunities (IROs) arising from sustainability aspects. Standards and initiatives such as the UN Global Compact, the OECD Guidelines for Multinational Enterprises and international anti‐corruption standards were also considered. The following were identified as material:
Negative impacts
Corporate culture
- A lack of a welcoming culture can weaken employees' sense of belonging and motivation.
- Misconduct by managers and inadequate ethical standards can have a negative impact on the working atmosphere and productivity.
- Low ESG requirements for business partners can have negative effects along the value chain, including on employee satisfac‐ tion, emissions and biodiversity.
- A weak corporate culture can foster corruption, anti‐competitive behaviour and environmental pollution.
- The introduction of a plasma donation market could lead to public discussions, particularly with regard to the economic situ‐ ation of vulnerable groups.
- The dependency of patients on plasma donations can lead to ethical debates and increased demands for transparency.
Protection of whistleblowers
Insufficient protection against retaliation can jeopardise the career, well‐being and trust of whistleblowers.
Preventing and detecting corruption and bribery
- Bribery can increase drug prices, impede access and favour unsafe drugs, especially in countries with weak regulation.
- Non‐transparent or unfair handling of incidents can affect the well‐being of employees.
Risks
Corporate culture
- A negative corporate culture can make it more difficult to motivate, retain and recruit skilled workers.
- It has the potential to damage a company's reputation and erode the trust of stakeholders.
- A negative image can erode donor confidence and reduce plasma donations.
Management of supplier relationships and payment practices
Stricter regulations on sustainable supply chains can increase investment and operating costs.
Preventing and detecting corruption and bribery
Corruption in the value chain can cause supply disruptions and financial losses.
Opportunities
Protection of whistleblowers
Detecting illegal activity early and responding quickly can minimise the damage.
Preventing and detecting corruption and bribery
A strong risk management and compliance culture can avoid costs due to corruption.
Concepts related to corporate policy and corporate culture (G1‐1)
The corporate policy of Biotest AG is laid down in internal guidelines and codes and is regularly reviewed and updated. These guide‐ lines include the Code of Conduct, a Supplier Code of Conduct, compliance guidelines and data protection guidelines:
Code of Conduct and internal guidelines
Biotest has implemented a comprehensive Code of Ethics and Business Conduct to embed these values. This code serves as a guide for all employees and defines clear standards for ethical behaviour, dealing with conflicts of interest and compliance with legal require‐ ments. It is regularly reviewed and updated as needed to meet current legal and societal requirements.
Training programmes
Targeted training programmes support the implementation of our corporate values. New employees attend introductory events where they are familiarised with the Biotest values and Code of Conduct. In addition, regular training is provided on topics such as compliance, data protection and ethical behaviour to raise awareness of these issues and ensure that all employees are up to date.
Internal communication activities
Transparency is very important to Biotest. For thisreason, the company relies on open and regular communication. Internal newsletters, staff meetings and the intranet serve as platforms for providing information about company developments, successes and upcoming projects. These communication channels promote the exchange of ideas between different levels and departments and help to create a common understanding of the company's goals and values.
Exchange formats and internal audits
To ensure the effectiveness of the implemented measures, Biotest regularly organises exchange formats with employees (e.g. town hall meetings, ask the management, etc.). These offer employees the opportunity to provide feedback, identify potential for improvement and express their satisfactionThe results of these events are carefully analysed and used to develop our corporate culture. In addition, internal audits are conducted to verify compliance with the Code of Conduct and Group policies. These audits help to identify any weak‐ nesses and to initiate appropriate improvement actions.
These guidelines are part of the internal control system and are subject to annual review by various departments and the Board of Management.
Description of the procedures for identifying and assessing the main impacts, risks and opportunities (IRO‐1)
Biotest AG has implemented a structured process to identify, assess and manage significant impacts, risks and opportunities (IROs) and implemented it at its headquarters in Dreieich. This process is based on the requirements of the ESRS and integrates both the inside‐out perspective (influence of the company on the environment and society) and the outside‐in perspective (influence of external factors on the company). The following steps have been taken to identify and assess the IROs:
Identification of relevant issues
- Analysis of legal and regulatory requirements for companies in the pharmaceutical industry (e.g. CSRD, EU taxonomy, LkSG).
- Industry and competition analyses (Merck, Octapharma, Takeda, etc.) to identify relevant ESG risks and opportunities.
- Consideration of internal company guidelines and strategic goals of Biotest AG.
- Inclusion of stakeholder feedback, particularly from investors, customers and employees.
Valuation methodology
- Sustainability‐related materiality: Assessment of extent, scope, remediation options and probability.
- Financial materiality: Identification of financial risks and opportunities through scenario analyses, assessment of cost and in‐ come potential, and consideration of external market conditions.
Stakeholder engagement
- Indirect engagement of relevant stakeholder groups through the relevant departments of Biotest AG (suppliers, authorities, customers, science).
- Use of internal working groups (Team Environment, Team Social, Team Governance) to analyse sector‐ and company‐specific ESG factors.
Integration in corporate risk management
In 2024, Biotest AG initiated the process of establishing a connection between ESG topics and the existing risk management system for ongoing monitoring and control. This initiative is expected to result in the integration of IRO results into the com‐ pany's strategic decision‐making processes in the medium term.
Reporting and transparency
- Regular updates to the materiality analysis.
- Publication of material IROs in the sustainability report in accordance with ESRS requirements.
- External audit of the processes to ensure the quality of the report.
Measures and resources
To implement its corporate policy, Biotest AG across all group companies relies on specific measures and resources, which are described in more detail below:
- Training programmes: Mandatory training for the group employees and managers on compliance, data protection and cor‐ ruption prevention.
- Internal control mechanisms for the group: Implementation of a whistleblower system for anonymousreporting of violations.
- ESG risk management: Integration of sustainability risks into the group‐wide Enterprise Risk Management System (ERM) by the end of 2025 to identify, assess and manage ESG risks in all relevant business areas. Progress will be documented in annual reports to the Risk Management Committee.
- Regular audits and controls: External and internal audits within the group to ensure compliance with company guidelines and regulatory requirements.
- Stakeholder dialogues: Exchanges with business partners, authorities and investorsto continuously improve governance prac‐ tices.
These measures and performance indicators are part of the annual sustainability report of Biotest AG and are monitored by the Sustain‐ ability Review Board.
Targets of corporate policy
Biotest AG sets itself clear targets for improving its sustainability performance and monitors these using measurable performance indicators. In some areas, measurable indicators are still being developed.
Biotest is committed to high compliance standards and aims to ensure that 100% of all relevant employees attend compliance and anti‐ corruption training each year. The year 2024 serves as a baseline with a training rate of 77.68% of relevant employees.
- Indicator: Percentage of employees trained per year.
- Monitoring and validation: The Compliance Department reviews participation rates on a quarterly basis; an internal audit is planned for future reporting years.
- Method: All training is documented, and from 2025 this will include an extended record of methods and assumptions, such as counting completed training, etc.
Biotest's goal is to fully integrate all material ESG criteria into internal risk analyses by 2026. This should ensure that environmental, social and governance aspects are systematically considered in the Risk Management System (RMS). Progress will be measured by the number of risk analyses with ESG considerationsfrom 2025 onwards. To monitor this, an annual report will be presented to the Portfolio Committee Risk Management and the Sustainability Review Board. In addition, a semi‐annual review will be conducted to identify devi‐ ations at an early stage and adjust actions.
An internal review will be conducted from Q4 2025 to validate the integration of ESG. ESG risks will be defined through regular work‐ shops with internal departments, with future involvement of suppliers.
The target is based on international standards such as the EU taxonomy, OECD guidelines and the UN Sustainable Development Goals (SDGs). Data sources include internal risk analyses, industry reports and stakeholder feedback. National legal requirements, in particular the Swiss Supply Chain Due Diligence Act (LkSG), are also incorporated into the definition of ESG criteria.
Progress on ESG integration is published in the annual Sustainability Report and supplemented by a trend analysis to identify material deviations at an early stage and make adjustments where necessary. This comprehensive governance integration strengthens Biotest's long‐term sustainability strategy and risk resilience.
Data protection and cybersecurity: A specific target will be defined for the 2025 reporting year.
Supply chain transparency: A target will be defined for the 2025 reporting year.
Business Conduct and Integrity
Whistleblower system and mechanisms for detection, reporting and investigation
Biotest AG provides all employees and externalstakeholders with a secure and anonymous whistleblowersystem. This enables violations of the Code of Conduct and potential compliance violations to be reported via various reporting channels:
- Investigation: Information can be submitted via a digital platform, a telephone hotline or directly to the Compliance, Internal Audit and Human Resources departments.
- Reporting & Investigation: All reports are analysed by Compliance and Internal Audit according to a defined procedure and, if necessary, reported to the Board of Management. An internal investigation team assesses the relevance of the information and takes action if necessary. The process is transparent, objective and confidential.
- Stakeholder involvement: The system is open to employees, business partners, suppliers and external regulators. Reports can be made anonymously or openly.
Protection for whistleblowers
Biotest consistently protects whistleblowers from retaliation and discrimination. The protective measures include the following:
- Anonymous reporting channels: A secure, anonymous system ensures that violations can be reported risk‐free.
- Awareness‐raising and training: Employees are regularly informed about their rights and obligations as whistleblowers.
- Professional processing: Trained compliance officers ensure that all reports are professionally reviewed in accordance with applicable data protection and confidentiality guidelines
Protective measures in accordance with EU Directive 2019/1937 in line with the Whistleblower Protection Act
Internal reporting channels: Biotest works to ensures that all employees are informed about internal reporting channels and can use them without barriers. The whistleblower system meets the requirements of the Directive (EU) 2019/1937 and its national implemen‐ tation in the Whistleblower Protection Act (HinSchG). It enables safe and confidential reporting through a digital platform, a telephone hotline and personal contacts. Safeguards include full protection of the whistleblower's identity and an explicit prohibition of retaliation in accordance with legal requirements. All reports received are reviewed and handled in accordance with data protection and confiden‐ tiality rules. Whistleblowers are actively protected from negative consequences or discrimination. This is done through internal policies and the Whistleblower Protection Act.
Measuresto protect whistleblowersfrom retaliation by their own employees, in accordance with the applicable legislation implementing Directive (EU) 2019/1937:
- Guarantee of confidentiality: The identity of the whistleblower is treated in strict confidence and information about a report is only made available to authorised persons.
- Protection from adverse employment actions: Whistleblowers are protected from termination, demotion, pay cuts, transfer or other adverse employment actions.
- Anti‐discrimination measures: Any form of discrimination or intimidation against whistleblowers is prohibited and will be rig‐ orously pursued.
-
Investigating and sanctioning retaliation: Possible reprisals against whistleblowers are investigated internally and disciplinary action is taken against those responsible for violations.
-
Access to legal remedies and support: Whistleblowers are given access to legal advice and, if necessary, support from internal or external ombudspersons.
- Reviewing the effectiveness of protective measures: Regular audits and reports on the effectiveness of the protection mech‐ anism ensure that whistleblowers remain free from retaliation.
Preventing and detecting corruption and bribery (G1‐3)
Preventive measures
Biotest AG has implemented a comprehensive anti‐corruption system. This includes mandatory training, internal controls and a central whistleblower system. Biotest defines 'compliance' as a set of internal company policies and procedures designed to prevent, detect and correct any unlawful conduct or practices that are not in line with the company's ethical standards and business practices. A central component isthe Code of Business Ethics and Conduct, which serves as a guide for all employees and sets out clearstandards of conduct and measures to prevent corruption. To detect and address allegations of corruption, Biotest has implemented a whistleblower system that allows employees and third parties to anonymously report potential misconduct. This system ensures the protection of whistle‐ blowers and the confidential treatment of all incoming reports.
Internal investigations at Biotest are conducted by specialised compliance officers who are organisationally separate from the opera‐ tional business units. This separation is intended to ensure that investigations are conducted independently and without influence from the management levelsinvolved. The Compliance department reports directly to the Board of Management, which ensures an additional level of independence and transparency.
Once an investigation has been completed, the results are summarised in a detailed report. Quarterly reports on compliance and cor‐ ruption risks are submitted to the Board of Management and the Audit Committee of the Supervisory Board, which decide on any necessary action. In cases of significant consequence or where members of the Board of Management are involved, the Supervisory Board Chairman is informed accordingly. Final reports include a risk assessment, recommended countermeasures and an action plan to prevent future violations. The Supervisory Board may order additional internal or external audits to verify the effectiveness of the measures taken. This process should ensure that all relevant levels of management are informed of significant compliance incidents and that appropriate steps can be taken to minimise risk and improve processes.
Cases of corruption or bribery (G1‐4)
0 reported violations or convictions during the reporting period. No fines were paid for non‐compliance.
78 % of all employees were trained and 81 % of at‐risk employees were trained. Functions involving risk are defined as follows: All employees who, due to their job description and/or actual practice, are in contact with health care professionals ('HCPs')/members of specialist groups and health care organisations (i.e. organisations in which HCPs are primarily employed) on more than an exceptional basis.
| Anti‐corruption and anti‐bribery training |
Functions at risk | Managers | AMSB | Other own workers |
|---|---|---|---|---|
| Covered by training | ||||
| Total | 198.0 | 32.0 | 4.0 | 2,432.0 |
| Total employees trained | 159.0 | 32.0 | 3.0 | 1,877.0 |
| Training method and duration (in hours) |
||||
| Classroom training | 1.0 | – | – | 0,25 ‐ 1,5 |
| Computer‐based training | 0.7 | 0.7 | 0.7 | 0.7 |
Table XIII (G1‐AR8): Anti‐corruption and anti‐bribery training
The topics covered in the online training courses for all employees (40 minutes each) and in the face‐to‐face training courses for partic‐ ularly risk‐prone groups of employees(60 minutes each) include the definition of corruption (How do I recognise corruption and bribery? What is allowed under the company's compliance guidelines and what is prohibited?) Strategies for avoiding corruption and bribery (How do I act so as not to run the risk of committing corruption or bribery?) and the procedures within the company regarding suspicion and detection (whistleblower protection system, whistleblowing hotline, internal audit). Training for all employees takes place once a year.
Management of relations with suppliers (G1‐2) and payment practices (G1‐6)
Biotest AG pursues a responsible and cooperative approach to supplier management in order to ensure sustainable, transparent and efficient cooperation along the entire value chain. The company regardsitssuppliers as essential partnersfor long‐term businesssuccess and for maintaining high quality, safety and ESG standards.
To prevent late payment and ensure fair and transparent business relationships, Biotest has implemented measures that apply to all suppliers, regardless of their size. This creates financial planning security and strengthens trust in the cooperation.
For various types of contracts, such as work, service, purchase, maintenance and rental contracts, Biotest AG has set specific payment periods that vary between 14 and 90 days. These clearly defined deadlines are designed to ensure that all suppliers, including small and medium‐sized enterprises (SMEs), receive their payments in a timely manner.
The current average payment term is 33 days48. Although the company currently has 0 legal proceedings pending for late payment, it aims to reduce the standard payment period for all main supplier categories to 30 days (n/a). There is currently no record of the com‐ pany's payments in days, broken down by main categories of suppliers, and the percentage of its payments in which these standard terms and conditions are applied. However, Biotest plans to record and disclose this value in the future.
Strategy to avoid late payments: Biotest relies on digital payment processes, regular internal payment reviews and early communication with suppliers to avoid delays.
Environmental, social and governance (ESG) criteria are very important to Biotest AG when selecting its suppliers. A key component of thisstrategy isthe Code of Conduct for Suppliers, which requires suppliersto comply with social and environmentalstandards. This code is based on internationally recognised standards, including the United Nations Universal Declaration of Human Rights, the ILO Core Labour Standards and the principles of the UN Global Compact. Suppliers undertake, among other things, to avoid forced and child labour, to ensure fair working conditions and to comply with environmental regulations.
Biotest AG maintains a proactive relationship with its suppliers to ensure a sustainable and responsible supply chain. Regular risk anal‐ yses are used to verify compliance with the defined standards. The development of preventive and corrective measures (in accordance with the Supply Chain Due Diligence Act) is still in progress. Biotest plans to intensify the dialogue with suppliers in order to jointly develop sustainable and fair payment practices. If necessary, measures to improve the situation will be developed together with suppli‐ ers in the future. This approach should not only minimise risks in the supply chain in the future, but also strengthen long‐term partner‐ ships and promote a culture of continuous improvement.
Cybersecurity at Biotest AG (Entity‐specific)
Cybersecurity was assessed as a benchmark topic in the materiality analysis. In this assessment, the topic was identified as a critical risk because attacks have a direct impact on patient care, regulatory compliance, and business operations. The pharmaceutical industry is a prime target for cyber attacks due to the sensitive nature of health data, and Biotest hasimplemented Group‐wide measuresto minimise the risk. The topic is not included in the incentive systems for remuneration.
Cyberscurity risks and negative impacts
Negative impacts
IT systems can be the target of effective cyber‐attacks. The loss and possible misuse of personal data has many consequences for the individual. These may include loss of privacy combined with psychological distress, damage to reputation, risk of iden‐ tity theft or legal and administrative challenges.
48 The figure was determined on the basis of a representative calculation for a period of 6 months in 2024. The calculation of the average payment period refers to Biotest AG, as this is where by far the majority of payment transactions take place.
Cyber‐attacks can cause IT systemsto fail, preventing Biotest from operating certain areasfor a period oftime. The operational downtime (e.g. plasma purchasing, plasma donation, shipping) may affect patient care. Cyber‐attacks can disrupt operations such as plasma purchasing, donations or shipping, thereby disrupting operations and affecting patient care.
Risks
- Fines, penalties, sanctions or remediation costs for breaches of employee privacy rights due to an inadequate cybersecurity profile. IT systems are vulnerable to cyber‐attacks that can result in data breaches, identity theft and reputational damage.
- Cyber‐attacks can cause IT systems to fail, resulting in Biotest being temporarily unable to operate certain areas. The opera‐ tional downtime (e.g. plasma purchases, plasma donations, shipping) could result in loss of revenue and/or reputational dam‐ age to Biotest.
Time horizons for cybersecurity impacts
Short‐term (less than 1 year):
- Immediate impact of business interruption due to cyber‐attacks (e.g. plasma purchasing or shipping halted).
- Immediate financial losses due to IT failures, ransomware or data breaches.
- Damage to reputation with customers, patients and partners due to security breaches.
- Initial regulatory consequences such as fines or sanctions from data protection authorities.
Medium‐term (1‐5 years):
- Increase investment in IT security and defensive measures to meet regulatory requirements.
- Adjustment of business processes to improve resilience to cyber‐attacks.
- Increased insurance costs due to higher risk profile.
- Potential market losses if customers lose confidence in Biotest due to security concerns.
Long‐term (5+ years):
- Long‐term reputational consequences that affect market position and business opportunities.
- Development and implementation of new cyber security standards and technologies.
- Possible regulatory changes and increased compliance requirements requiring significant investment in security measures.
- Long‐term financial risks if structural security weaknesses are not addressed and repeated attacks occur.
Governance and control
Biotest has established a clear governance structure to monitor and control the cybersecurity strategy. Responsibility lies with the rele‐ vant departments, which report regularly to the Board of Management. Defined escalation and reporting processes ensure efficient handling of security incidents, while the strategy is reviewed and updated annually. Cybersecurity is not part of the incentive system that is included in the compensation.
As a pharmaceutical company, Biotest has a special responsibility to protect personal data and IT systems. Compliance with regulatory requirements (e.g. GxP compliance, GDPR) is essential. Specialist teams in the Corporate IT department monitor and develop security measures. The Board of Management is directly involved in risk assessment and makes strategic decisions to improve IT security. Risk assessment is a multi‐stage process that includes regular penetration testing, network monitoring and log analysis.
Risks are assessed based on their likelihood of occurrence and potential impact.
The main risks include data loss, cyber‐attacks and unauthorised access to protected systems. To minimise the risks, Biotest relies on technical protective measures such as firewalls, encryption and access controls, procedural measures such as escalation processes, inci‐ dent response plans and disaster recovery tests, and organisational measures such as regular training and awareness campaigns for employees.
To ensure continuous improvement of IT security, Biotest maintains regular reporting structures. Security and risk reports are submitted to the Board of Management, management and supervisory bodies and include audit results, security‐related incidents and recom‐ mended measures
Targets
Biotest has clear targets in the area of cyber security:
- Protect sensitive company and patient data from cyber attacks and data leaks.
- Ensure business continuity through robust IT security measures.
- Meet regulatory requirements (GxP, GDPR, ITIL, GAMP5) for compliance and audit security.
- Promote a culture of security through training and awareness.
- Minimise cyber risks through preventive measures and continuous improvement.
These targets will be complemented by quantifiable metrics for the following years and will be disclosed in the next reporting period.
Concept and measures
Biotest pursues a comprehensive cyber security strategy to minimise security risks and protect its IT infrastructure. The security concept integrates physical, digital and organisational measures, which are regularly reviewed and adapted to new challenges.
Physical and digital safeguards are a key component of the strategy. Access controls for IT systems and servers prevent unauthorised access, while targeted network segmentation reduces the risk of cyber attacks. In addition, all stored data is subject to strict security policies.
To ensure robust network security, Biotest uses modern security and protection systems to detect threats at an early stage. Regular security checks help to identify potential weak points.
Another important aspect is access and identity management, based on strict user and access controls. Access to critical systems is subject to clearly defined authorisation rules to prevent unauthorised use.
In the event of a security incident or technical failure, a comprehensive emergency and incident management system is in place. A structured procedure should ensure that IT systems can be quickly restored, while defined processes enable a coordinated response to incidents. In addition, regular audits and security reviews are conducted to ensure compliance with regulatory requirements.
In addition to technical measures, Biotest attaches great importance to sensitising its employees to cyber security risks. In regular secu‐ rity awareness training sessions, they are trained to recognise potential threats and to act accordingly. Targeted training and measures promote a company‐wide security culture in which all employees actively contribute to the protection of IT systems.
Progress and monitoring
A structured monitoring and control system ensures the effectiveness of the cybersecurity strategy and the early detection of vulnera‐ bilities. This includes technical monitoring measures, regular audits and targeted reviews of employee awareness.
Technical monitoring and testing is a key component ofsecurity monitoring. Modern systems are used to analyse security‐related events in order to identify potential threats at an early stage. In addition, regular security audits and tests are conducted to identify and reme‐ diate vulnerabilitiesin the IT infrastructure. Continuous monitoring of access and suspicious user behaviour helpsto detect unauthorised activities at an early stage.
Biotest relies on audits and compliance controls to ensure compliance and continuous improvement of security measures. Regular re‐ views of security policies ensure that internal and external requirements are met. In addition, access rights are regularly reviewed to ensure that only authorised persons have access to critical systems.
In addition to technical and organisational measures, employee awareness plays a fundamental role. Targeted training and security measures are used to raise awareness of cyber risks. Feedback and training analytics are used to evaluate and adjust the effectiveness of these measures.
Stakeholder engagement
Although there is currently no formalised stakeholder dialogue on cybersecurity, Biotest plans to increase the involvement of business partners, donors and patients. The aim is to better understand data protection requirements and integrate them into the strategy. At the same time, supplier requirements will be reviewed to ensure that external partners also adhere to high security standards.
F.V. ESRS DISCLOSURE REQUIREMENTS AND IMPLEMENTATION STATUS
| The following table provides an overview of the ESRS disclosure requirementsincluded in the Sustainability Report and the status of their implementation |
|||||
|---|---|---|---|---|---|
| ESRS Stand‐ ard |
DR | Description | Status of application | ||
| ESRS 2 | BP‐1 | General information for the preparation of the sustainability report declaration | applied | ||
| BP‐2 | Information related to specific circumstances | applied | |||
| GOV‐1 | The role of the Board of Management the Supervisory Board | partially applied | |||
| GOV‐2 | Information and sustainability aspects addressed by the Board of Management and the Supervisory Board |
applied | |||
| GOV‐3 | Inclusion of sustainability performance in incentive systems | applied | |||
| GOV‐4 | Statement on due diligence | applied | |||
| GOV‐5 | Risk management and internal controls in sustainability reporting | applied | |||
| SBM‐1 | Strategy, business model and value chain | applied | |||
| SBM‐2 | Stakeholder interests and perspectives | applied | |||
| SBM‐3 | Material impacts, risks and opportunities and how they relate to the strategy and business model |
applied | |||
| IRO‐1 | Description of the process for identifying and assessing material impacts, risks and opportunities |
applied | |||
| IRO‐2 | Disclosure requirementsincluded in ESRS covered by the organisation'ssustain‐ ability statement |
applied | |||
| E1 | GOV‐3 | Inclusion of sustainability‐related performance in incentive systems | applied | ||
| E1‐1 | Transition plan for climate protection | partially applied | |||
| SBM‐3 | Significant impacts, risks and opportunities and their interaction with strategy and business model |
applied |
| IRO‐1 | Description of the processes for identifying and assessing significant climate‐ related impacts, risks and opportunities |
applied | |
|---|---|---|---|
| E1‐2 | Concepts related to climate protection and adaptation to climate change | applied | |
| E1‐3 | Measures and means in connection with the climate concepts | partially applied | |
| E1‐4 | Targets related to climate change mitigation and adaptation | partially applied | |
| E1‐5 | Energy consumption and energy mix | applied | |
| E1‐6 | Scope 1, 2, 3 and total GHG emissions | partially applied | |
| E1‐8 | GHG removals and GHG reduction projects financed through carbon credits | applied | |
| IRO‐1 | Description of the procedures for identifying and assessing the principal im‐ pacts, risks and opportunities associated with water and marine resources |
applied | |
| E3‐1 | Concepts associated with water and marine resources | partially applied | |
| E3 | E3‐2 | Measures and means associated with water and marine resources | partially applied |
| E3‐3 | Targets associated with water and marine resources | applied | |
| E3‐4 | Water consumption and reuse | partially applied | |
| IRO‐1 | Description of processes for identifying and assessing significant impacts, risks and opportunities associated with resource use and circular economy |
applied | |
| E5‐1 | Concepts related to resource use and circular economy | applied | |
| E5 | E5‐2 | Measures and means related to resource use and circular economy |
applied |
| E5‐3 | Targets related to resource use and circular economy | applied | |
| E5‐4 | Resource inflows | partially applied | |
| E5‐5 | Resource outflows | applied | |
| S1 | SBM‐2 | Interests and perspectives of stakeholders | partially applied |
| SBM‐3 | Material impacts, risks and opportunities and their interaction with the strategy and business model |
applied | |
| S1‐1 | Concepts related to the organisation's workforce | partially applied | |
| S1‐2 | Procedures for involving the organisation's workers and their representativesin relation to impacts |
applied | |
| S1‐3 | Procedures for improving negative impacts and channels for the organisation's workers to provide feedback and voice concerns |
partially applied | |
| S1‐4 | Actions taken in relation to significant impacts on the organisation's workers and approaches to managing significant risks and opportunities related to the organisation's workers; and the effectiveness of those actions |
partially applied | |
| S1‐5 | Targets related to addressing significant negative impacts, promoting positive impacts and managing significant risks and opportunities |
partially applied |
| S1‐6 | Characteristics of the company's employees | applied | |
|---|---|---|---|
| S1‐9 | Characteristics of the company's external workforce | applied | |
| S1‐10 | Collective bargaining coverage and social dialogue | applied | |
| S1‐14 | Diversity indicators | applied | |
| S1‐16 | Decent remuneration | partially applied | |
| S1‐17 | Social security | applied | |
| SBM‐2 | Stakeholder interests and perspectives | applied | |
| SBM‐3 | Material impacts, risks, and opportunities, and how they interact with the strat‐ egy and business model |
partially applied | |
| S4‐1 | Concepts related to consumers and end users | applied | |
| S4‐2 | Processes for engaging consumers and end users regarding impacts | applied | |
| S4 | S4‐3 | Processes for improving negative impacts and channels for consumers and end users to provide concerns |
partially applied |
| S4‐4 | Measures taken to address material impacts on consumers and end‐users and approaches to managing material risks and opportunities related to consumers and end‐users, and the effectiveness of these measures |
partially applied | |
| S4‐5 | Targets related to addressing material negative impacts, driving positive im‐ pacts, and managing material risks and opportunities. |
partially applied | |
| G1 | GOV‐1 | The role of the Board of Management and the Supervisory Board | applied |
| IRO‐1 | Description of the procedures for identifying and assessing the principal im‐ pacts, risks and opportunities |
applied | |
| G1‐1 | Corporate culture and concepts for corporate governance | applied | |
| G1‐2 | Management of relationships with suppliers | applied | |
| G1‐3 | Prevention and detection of corruption and bribery | applied | |
| G1‐4 | Cases of corruption or bribery | applied | |
| G1‐6 | Payment practices | applied |
G. TAKEOVER‐RELEVANT INFORMATION PURSUANT TO SECTIONS 315A / 289A HGB
The subscribed capital of Biotest AG amounts to € 39,571,452.00 in accordance with the Articles of Association (as of: 31 December 2024). It is divided into 19,785,726 ordinary shares and 19,785,726 preference shares. The shares are bearer shares; the preference shares do not carry any voting rights. Biotest is not aware of any further voting rights or transfer restrictions.
Following the implementation of a public acquisition offer in accordance with the regulations of the German Securities Acquisition and Takeover Act (WpÜG), on 25 April 2022 Grifols, S.A., Barcelona, Spain, notified Biotest pursuant to Sections 33 (1), 34 of the German Securities Trading Act (WpHG) that Grifols, S.A., indirectly held 96.20 % of the ordinary shares and thereby of the voting rights in Biotest AG. On 2 May 2022, Grifols, S.A., announced pursuant to Section 23 (2) Sentence 1 of the German Securities Acquisition and Takeover Act (WpÜG) that Grifols, S.A., has indirectly acquired an additional 0.94 % of the voting rights in Biotest AG. As a consequence, Grifols, S.A., indirectly holds a total of 97.14 % of the voting rightsin Biotest AG. The voting rightsin Biotest AG are held directly by Grifols Biotest Holdings GmbH, Frankfurt, which is controlled by Grifols, S.A., and attributed to Grifols, S.A., pursuant to Section 34 WpHG. As a conse‐ quence, Biotest AG is indirectly controlled by Grifols, S.A., Barcelona, Spain (status as of: 31 December 2024).
As of 31 December 2024, the Board of Management was not aware of any further direct or indirect shareholdings in the company exceeding 10 % of the voting rights. There are no holders of shares with special rights conferring powers of control.
Members of the Board of Management are appointed and dismissed by the Supervisory Board in accordance with Sections 84 and 85 of the German Stock Corporation (AktG) and Section 7 (2) of the company's Articles of Association. Pursuant to Section 179 (1) AktG, any amendment to the company's Articles of Association requires a resolution of the Annual General Meeting (Section 133 AktG). Authori‐ sation to amend the Articles of Association affecting only their wording has been transferred to the Supervisory Board pursuant to Section 27 of the Articles of Association in compliance with Section 179 (1) Sentence 2 AktG.
At present, no authorisation exists to purchase treasury shares pursuant to Section 71 (1) Sentence 8 AktG (status as of: 31 December 2024). In order to give Biotest AG flexibility in future financing and capital measures, resolutions passed at the Annual General Meeting on 7 May 2019 created a new authorised capital and replaced the previous authorised capital, which the Board of Management had not utilised. Section 4 (5) of the Articles of Association was cancelled and reworded as follows: "The Board of Management shall be author‐ ised, with the approval of the Supervisory Board, until 6 May 2024, to increase the company's share capital by issuing new bearer shares and/or issuing new bearer preference shares without voting rights against cash capital contributions and/or non‐cash capital contribu‐ tions, once or on several occasions, by up to € 19,785,726.00 (Authorised Capital). This authorisation includes the authority to issue further preference shares that are equal to the previously issued non‐voting preference shares in the distribution of profits or company assets. The shareholders shall be entitled to a subscription right. The subscription right may also be structured in whole or in part as an indirect subscription right in the meaning of Section 186 (5) Sentence 1 AktG. The Board of Management shall also be authorised to determine the further details of the implementation of capital increases from authorised capital." In addition to the above amendment to the Articles of Association, the Supervisory Board was authorised by resolution of the Annual General Meeting to adapt the Articles of Association after complete or partial implementation of the increase of the authorised capital in accordance with the volume of the capital increase. The Authorised Capital was not utilised, including not in part, until the authorisation expired on 6 May 2024.
The Annual General Meeting on 7 May 2024 did not pass a resolution concerning the creation of new authorised capital or the corre‐ sponding amendment to the Articles of Association, as a consequence of which no authorised capital is currently available (as of 31 December 2024).
Significant agreements between Biotest AG and third parties that take effect in the event of a change of control existed with regard to the financing agreements that have been concluded. The right of termination is excluded for a transfer of control to Grifols, S.A. Full repayment under the financing agreements was realised on 2 August 2024, as a consequence of which the agreements relating to a change of control were terminated.
The contract of Board of Management member Peter Janssen contains a severance payment provision that takes effect in the event that the Board of Management contract is terminated early as a consequence of a change of control defined in more detail. The severance payment comprises the fixed remuneration for two years as well as a bonus payment for two years based on the average amount of the two previous financial years and the utility value of the company car granted for two years.
No entitlement exists if the Board of Management employment contract is terminated on good grounds, or due to illness or incapacity to work, or if the Board of Management member receives monetary or non‐monetary benefits from third parties in connection with the change of control. The contracts of the Board of Management members who stepped down from office, Dr. Jörg Schüttrumpf (who stepped down on 31 August 2024) and Ms. Ainhoa Mendizabal Zubiaga (who stepped down on 10 September 2024), contained similar provisions. Mr. Martin Möller's Board of Management contract does not contain such a severance payment provision.
H. NOTES TO THE FINANCIAL STATEMENTS OF BIOTEST AKTIENGESELLSCHAFT (HGB)
The following information relates to the parent company Biotest AG. The information provided in this section supplements the infor‐ mation provided in the preceding sections.
H.I. THE COMPANY'S BUSINESS MODEL
As the parent company of the Biotest Group, Biotest AG is an internationally active supplier of biological pharmaceuticals. Marketed products as well as new developments are obtained both from human blood plasma and manufactured using biotechnology processes. The main therapeutic areas for application are hematology, clinical immunology, and intensive care medicine. In addition, the company markets available capacities within the framework of toll manufacturing.
Biotest AG conducts research and development work in all three therapeutic areas, with the company essentially carrying out research and development on behalf of its subsidiary Biotest Pharma GmbH, Dreieich, Germany.
H.II. CORPORATE STRUCTURE
Biotest AG is a public limited company under German law; the company's registered office is located in Dreieich, Germany. The shares of Biotest (both the ordinary and the preference shares) have been listed on the stock exchange (XETRA, Frankfurt am Main) since 1987, and the preference shares are also listed in Deutsche Börse's Prime Standard. Additionally, the shares are traded on other regional stock exchanges in Germany.
As the parent company, Biotest AG is managed and controlled by the Board of Management and the Supervisory Board in accordance with the dual control principle established in Germany. In accordance with the company's Articles of Association, the Board of Manage‐ ment may consist of one or more individuals. It works closely with the Supervisory Board, which regularly advises and monitors the Board of Management in its management of the company.
At the end of the 2024 fiscal year, the Board of Management consisted of two persons. Mr. Peter Janssen has been the CEO since 1 January 2024. His contract ends on 31 December 2026. Ms. Ainhoa Mendizabal Zubiaga resigned as Chief Financial Officer (CFO) on 10 September 2024. Mr. Martin Möller took over as Interim CFO on 15 September 2024, for six months. Dr. Jörg Schüttrumpf (Executive Board Member for Science and Medicine) will focus on his role as Chief Scientific Innovation Officer of the entire Grifols Group. There‐ fore, he resigned from his position as Chief Scientific Officer and Board of Management Member of Biotest AG effective 31 August 2024. The areas previously managed by Dr. Schüttrumpf at Biotest AG will now be represented by Mr. Janssen (CEO) on the Executive Board of Biotest AG.
The Supervisory Board of Biotest AG comprises six individuals; four of these are elected by the Annual General Meeting, and two mem‐ bers are elected by employees. The Supervisory Board has formed two committees in order to enhance its efficiency.
The Audit Committee is responsible for monitoring the financial accounting process, the adequacy and effectiveness of the internal control system, the risk management system, and the internal audit system, as well as the audit of the financial statements, in particular the selection and independence of the auditor and the additional services provided by the auditor. The Personnel and Remuneration Committee deals with issues relating to Board of Management contracts and its remuneration.
With effect from 1 January 2015, Biotest AG concluded a control and profit and loss transfer agreement with Biotest Pharma GmbH, Dreieich. The agreement may be terminated at the end of the financial year of the controlled company subject to a notice period of one year. This termination right was not exercised as of 31 December 2025.
In addition, an operating lease agreement exists with Biotest Pharma GmbH, which transferred the right to Biotest AG to use the facilities of Biotest Pharma GmbH, as well as the approvals and processes for the manufacture of plasmatic products, by way of leasing and licensing. Biotest Pharma GmbH remainsthe owner of the facilities and buildings as well asthe pharmaceutical marketing authorisations, and continuesto act asthe responsible party in the meaning of the German Drugs Act (AMG). Contracts were concluded between Biotest Pharma GmbH and Biotest AG for the implementation of investments in production facilities, for research and development work, and for the management of Biotest Pharma GmbH.
H.III. HUMAN RESOURCES
As of the year‐end, Biotest AG employed 1,709 individuals in 1,648 full‐time equivalent (FTE) positions. Compared to the previous year, 60 full‐time equivalents reflects an increase of 3.8 %.
H.IV. FINANCIAL PERFORMANCE INDICATORS
Due to its operating activities as well as its holding function, revenue as reported on the basis of the German Commercial Code (HGB) represents the most significant control parameter for the annual HGB financial statements of Biotest AG. Profitability is managed on the basis of the Group's IFRS figures.
H.V. RESEARCH AND DEVELOPMENT (GENERAL)
The research and development costs of Biotest AG amounted to € 56.6 million in the 2024 financial year (previous year: € 65.5 million). As far the company Biotest AG is concerned, the research and development costs for most development products are passed on to its subsidiary Biotest Pharma GmbH. The company employed an average of 241 people in the research and development area in the finan‐ cial year under review (previous year: 240).
H.VI. FORECAST‐ACTUAL COMPARISON
For the 2024 financial year, the Board of Management aimed for revenue growth in the lower single‐digit percentage range compared to 2023. The ongoing conflict in the Middle East harbours considerable risks for revenue and earnings. The economic instability in the region could have a negative impact on revenue and earnings. In addition, interruptions in the supply chain could lead to delays and higher costs. The Board of Management did not expect any direct negative effects from the Russian war of aggression in Ukraine, but did not rule out negative revenue and earnings trends due to potential cyclical downturns in demand, country‐specific savings in the healthcare sector, or production interruptions due to a lack of, or delays in, the availability of plasma, spare parts or personnel.
Biotest AG generated revenue of € 753.2 million in the financial year under review (previous year: € 664.8 million), corresponding to growth of 13.3 %. The target of increasing revenue by a low single‐digit percentage rate on average was exceeded, taking into consider‐ ation the special effectsfrom the agreement concerning technology disclosure and developmentservices(€ 123.1 million (previous year: € 190.1 million)), which was signed with Grifols, S.A., on 31 May 2023 with effect from 1 January 2023. Sales in Germany increased by 18.5 % compared to the previous year to € 182.1 million, while sales abroad were € 571.1 million, 11.7 % higher than the previous year.
As far as EBIT is concerned, the Board of Management assumed a range of between € 80 million and € 100 million for the Group in 2024. The operating earnings calculated in accordance with the financial accounting standards of the German Commercial Code (HGB) of Biotest AG amounted to € 59.5 million as of the reporting date. As the parent company and operating holding company of the Biotest Group, the risks, opportunities, and forecasts made in the previous year for the consolidated financial statements were also indicative of the trends expected for the company. The significant decline in EBIT in 2024 by € 65.3 million was due to lower earnings from tech‐ nology disclosure and development services amounting to € 68.9 million. Furthermore, Biotest AG continued to invest in the future and development of its products. In mid‐June 2024, the approval of Yimmugo® in the USA by the Food and Drug Administration (FDA) and the production at the Biotest Next Level facility contributed to strengthening EBIT and the production site in Dreieich.
H.VII. RESULTS OF OPERATIONS, NET ASSETS AND FINANCIAL POSITION
H.VII.1 BUSINESS SITUATION
Biotest AG achieved revenues of € 753.2 million in the fiscal year (previous year: € 664.8 million) with external business partners as well as within the group. This increase is mainly due to the successful market introduction of the intravenous immunoglobulin Yimmugo®, which is the first commercial product manufactured at the Biotest Next Level production facility in Dreieich. Since June 2024, the intra‐ venous immunoglobulin Yimmugo® has also been approved in the USA. This approval represents an important milestone on the path to a broader product portfolio.
The company divides its business activities into the geographic regions of Germany, the European Union, and the rest of the world. Sales in Germany increased by 18.5 % compared to the previous year to € 182.1 million, while salesin the rest of the world increased by 42.2 %
to € 316.6 million. Revenues from the technology transfer and licensing agreement amounting to € 123.1 million (previous year: € 190.1 million) include the agreement signed with Grifols, S.A., Barcelona, Spain, on May 31, 2023, effective January 1, 2023. As a result, sales in Europe decreased by 11.8 % compared to the previous year to € 254.5 million.
H.VII.2 RESULTS OF OPERATIONS
In addition to the operating activities of Biotest AG, the trend in the results of operations also reflect the holding function performed for the Group. This is evident in currency effects, cost allocations, as well as net interest and investment results.
With operating earnings of € 59.5 million (on the basis of the financial accounting standards of the German Commercial Code [HGB]), the company reported a net profit before taxes on income of € 53.5 million in the financial year under review, following a pre‐tax profit of € 133.6 million in the same period of the previous year. The HGB operating earnings decreased by € 65.4 million to € 59.5 million (previous year: € 124.9 million). This decline is influenced by the agreement reached with the Grifols Group concerning technology disclosure and development services. Accordingly, the operating margin (ratio of HGB operating earnings to revenue) deteriorated from 18.8 % in the previous year to 7.9 % in the reporting period.
Other operating income decreased by € 19.8 million compared to the previous year, amounting € 47.2 million. This decline resulted primarily from the sale of investment companies in the previous year, which accounted for € 31.1 million. A positive effect is the re‐ charging of project costs to Grifols for Fibrinogen in the fiscal year amounting to € 11.2 million.
Material expenses increased by 13.0 % from € 349.7 million to € 395.1 million in the fiscal year. Inventory changes amounted to € 49.0 million as of the reporting date (previous year: € 122.2 million). The increase in inventories is mainly due to the expansion of production volume. The increased material expenses are primarily due to higher costs for blood plasma, energy, and external controls, as well as increased write‐down requirements for factor VIII stocks.
Personnel expenses rose from € 156.5 million to € 173.1 million in the financial year under review, mainly due to a higher headcount compared to the previous year. Personnel expensesinclude costs of € 4.3 million for the increase in the number of employees. Addition‐ ally, € 6.4 million is included for the provision for profit sharing.
Other operating expenses decreased by € 0.7 million to € 219.5 million (previous year: € 220.2 million). The decrease is mainly due to the elimination of charges from the former Biotest France SAS, Paris, France, now Grifols France Sàrl, Paris, France, amounting to € 0.9 million. According to current legal regulations, different discounts are expected for various periods and products, which are included in non‐period expenses amounting to € 0.6 million in the fiscal year 2024. Lease and license expenses from the operating lease agreement with the subsidiary Biotest Pharma GmbH increased by € 5.4 million to € 74.3 million, while approval costs decreased by € 3.0 million, currency losses by €1.1 million, and expensesfor additionsto value adjustments on receivables by € 4.4 million compared to the previous year. Conversely, maintenance costs increased by € 2.4 million in the fiscal year.
The financial result of Biotest AG deteriorated by € 14.7 million year‐on‐year, and shows a net expense of € 6.0 million for 2024. This development is mainly due to the € 6.1 million lower profit transfer. Additionally, loss absorption from profit transfer agreements in‐ creased by € 9.3 million in the fiscal year. The interest result of € 29.3 million (previous year: € 32.2 million) is mainly burdened by interest expenses for loans, as in the previous year.
The net profit for the 2024 financial year deteriorated from € 122.8 million to € 47.9 million. In addition to effects from the operating business, the lower revenue level is attributable to the technology transfer and licensing agreement concluded with Grifols, S.A., Barce‐ lona, Spain, on 31 May 2023 with effect from 1 January 2023 in the amount of € 123.1 million (previous year: € 190.1 million).
H.VII.3 NET ASSETS
The total assets of Biotest AG grew from € 1,245.4 million to € 1,296.8 million in the financial year under review. With a carrying amount of € 486.8 million in the financial year under review (previous year: € 485.8 million), financial assets account for a significant share of around 37.5 % of total assets. Interests in affiliated companies are unchanged from the previous year. A key position within the shares in affiliated companies is the 100 % stake in Biotest Pharma GmbH, Dreieich. A significant position within the loans to affiliated compa‐ nies is the cash pool agreement amounting to € 31.2 million and the loan amounting to € 335.0 million with Biotest Pharma GmbH, Dreieich.
As far as the company's current assets are concerned, inventories amounted to € 504.3 million as of 31 December 2024, up 7.9 % on the previous year's level of € 467.3 million. The increase in inventory mainly concerns blood plasma and Yimmugo® and serves to expand production capacities and ensure market supply in the 2025 fiscal year.
Trade receivables from third parties, related parties and investments increased by 6.4 % to € 161.8 million. This includes major orders with contractual partners based in countries that are subject to sanctions. Some of these receivables have longer pay‐ment terms and are generally subject to foreign exchange restrictions and foreign exchange risks. Receivables due from affiliated companies decreased from € 15.2 million to € 13.0 million. The receivable from the profit transfer agreement with Biotest Pharma GmbH decreased by € 6.1 million to €0.0 million compared to the 2023 fiscal year, as Biotest Pharma GmbH had to absorb losses from its subsidiaries in the 2024 fiscal year.
Other assets decreased to € 10.4 million (previous year: € 9.9 million). Other receivables from tax authorities for VAT decreased to € 2.6 million (previous year: € 6.8 million).
The company's cash and cash equivalents amounted to € 117.3 million as of the end of the financial year under review (previous year: € 117.3 million). The equivalent values are mainly due to cash outflows from operating activities.
Provisions for pension benefits increased slightly from € 105.0 million in the previous year to € 107.1 million in the financial year under review. Other provisionsincreased from € 58.9 million to € 68.0 million and mainly relate to provisionsfor outstanding invoicesfor goods and services and profit‐sharing.
Liabilities to banks decreased to € 0.01 million in the fiscal year (previous year: € 1.5 million). Liabilities to affiliated companies increased to € 564.0 million (previous year: € 352.8 million) and mainly concern liabilities from cash management within the Biotest Group, as well as shareholder loans amounting to € 290.0 million nominally from Grifols Biotest Holdings GmbH, Frankfurt am Main, Germany, and € 197.3 million nominally from Grifols Worldwide Operations Ltd., Dublin, Ireland, including accrued interest.
The trade payables of Biotest AG also rose from € 43.3 million in the previous year to € 52.3 million as of the end of the financial year under review. Other liabilities decreased from € 310.2 million in the previous year to € 83.0 million as of the reporting date. The lower value is mainly due to the repayment of loans from third parties amounting to € 225 million.
Other liabilities also include a loan and related accrued interest in the amount of € 44.3 million (previous year: € 44.3 million), which was granted by a business partner and matures in the 2029 financial year.
In the coming financial year, the company also anticipates other financial commitments of € 369.2 million. These comprise purchase commitments under plasma supply agreements (€ 265.2 million), lease and licence expenses under the operating lease agreement with the subsidiary Biotest Pharma GmbH (€ 86.8 million), commitments under toll manufacturing (€ 4.8 million) and the supply of interme‐ diates (€ 6.7 million), as well as leasing and rental obligations (€ 5.7 million).
H.VII.4 FINANCIAL POSITION
As the parent company, Biotest AG performs the main financing function for the Biotest Group. The company's equity ratio stands 2.4 percentage points higher than in the previous year (29.9 %), amounting to 32.3 % as of the end of the financial year under review. The increase in the equity ratio reflects the rise in net profit for the financial year under review, and the corresponding growth in equity, which more than compensates for the simultaneous increase in total assets.
Financial debt and credit lines
Biotest isfinanced through a subordinated shareholder loan from Grifols Biotest Holdings GmbH, Frankfurt am Main (formerly Tiancheng (Germany) Pharmaceutical Holdings AG, Munich), Germany, amounting to € 290 million nominally, and a loan from an affiliated company of Grifols Worldwide Operations Limited, Dublin, Ireland, amounting to € 197.3 million nominally. The subordinated shareholder loan of € 290 million was extended on 15 March 2024, until 2 January 2030.
A loan from an affiliated company of Grifols Worldwide Operations Limited, Dublin, Ireland, in the nominal amount of € 147.0 million from 7 March 2023, and in the nominal amount of € 50.3 million from 29 November 2024, have been extended until 31 December 2026.
For collateralisation purposes, the Biotest AG has arranged for the registration of a senior land charge totalling € 581.7 million on the real estate assets located in Dreieich. The real estate assets provided as collateral by the Biotest AG have an IFRS carrying amount of € 2.0 million as of the reporting date (previous year: € 2.1 million).
Cash flows
Cash flow from operating activities improved from negative € 22.4 million in the previous year to positive € 41.3 million. The positive development was mainly due to the massive build‐up of inventories in the previous year amounting to € 150.2 million, which heavily burdened the operating cash flows of the 2023 fiscal year. This increase is primarily due to the rise in unfinished products in connection with the ramp‐up of the Biotest Next Level facility. Receivables from trade and other assets increased by € 3.7 million (previous year: € 3.1 million). On the liabilities side, trade payables and other liabilities decreased by € 14.6 million. Despite the positive effect, a decline is noted as the annual surplus generated in the fiscal year decreased from € 122.8 million in the previous year to € 47.9 million.
Cash flow from investing activities amounted to € ‐10.5 million (previous year: € 27.2 million), significantly below the previous year's level. Investing activities in property, plant, and equipment, as well as intangible assets, led to payments of € 5.1 million (previous year: € 4.0 million). Payments for intra‐group loans amounted to € 5.4 million in the fiscal year compared to € 3.7 million in the previous year. The previous year was positively influenced by the sale of shares in subsidiaries in Spain, Brazil, Italy, the United Kingdom, and France amounting to € 35.0 million.
Cash flow from financing activities amounted to € ‐30.7 million, significantly below the previous year's level of € ‐13.5 million. The main difference resulted from the repayment of external financing amounting to € 225.1 million. Intra‐group financing amounting to € 197.3 million (previous year: € ‐12.9 million) had a positive effect.
Cash and cash equivalents amounted to € 117.3 million at the end of the fiscal year 2024, roughly equivalent to the € 117.3 million as of 31 December 2023.
H.VIII. GENERAL STATEMENT BY THE BOARD OF MANAGEMENT REGARDING ON THE BUSINESS SITUATION AS WELL THE EARNINGS; NET ASSETS AND FINANCIAL POSITION
Biotest AG generated revenue of € 753.2 million in the financial year under review (previous year: € 664.8 million), and operating earn‐ ings (calculated on the basis of the financial accounting standards of the German Commercial Code [HGB]) of € 59.5 million (previous year: € 124.9 million). Total assets rose to € 1,296.8 million as at 31 December 2024 (previous year: € 1,245.4 million). The equity ratio of Biotest AG amounts to 32.3 % as of 31 December 2024, reflecting a year‐on‐year increase of 2.4 percentage points.
The company was able to meet its payment obligations at all times during the past financial year. Over the next twelve months, Biotest AG will utilise the financial support of its main shareholder Grifols, S.A. to ensure the acceleration of development activ‐ities and expan‐ sion of the production capacities of the Biotest Next Level facility.
H.IX.PROPOSED APPROPRIATION OF EARNINGS
With the achievement of a net profit of € 47,845,914.06 in the financial statements of Biotest AG for the 2024 financial year, the Board of Management and the Supervisory Board propose to use the balance sheet net profit of € 125,717,532,59 recognised in the financial statements of Biotest AG as follows:
| in € | |
|---|---|
| Distribution of a dividend | |
| of € 0.04 per dividend‐entitled preference share | |
| in relation to 19,785,726 non‐voting preference shares for the 2024 financial year | 791,429.04 |
| Total distribution | 791,429.04 |
| Profit carried forward to a new account | 124,926,103.55 |
H.X. SUPPLEMENTARY REPORT
Please refer to our commentsin section D 10 "Events after the balance sheet date" in the notesto the consolidated financialstatements.
H.XI.FORECAST, RISK AND OPPORTUNITY REPORT OF THE COMPANY
Expected business performance and results of operations
For the 2025 financial year, the Board of Management anticipates a reduction in revenue in the mid‐single‐digit percentage range com‐ pared to 2024. The reduction is primarily attributed to the loss of revenue from technology disclosure for Grifols, S.A., which was com‐ pleted in 2024.
In addition to the ramp‐up of the new production facility, the Board of Management considers as a particular challenge the continuous supply of human US plasma as the starting material for Biotest products intended for the American market. According to the Board of Management´s assessment, a lack of or delayed availability of plasma and the production of faulty batches due to commissioning could even lead to interruptions in production, revenue loss, and losses from scrapping.
Furthermore, the company generally faces the risk of the annual result being burdened by event‐related impairments of the carrying amounts of the subsidiaries' investments. The Board of Management assesses this risk as moderate.
Financial outlook
In addition, the statements made in relation to this risks, opportunities, and forecasts made for the consolidated financial statements are also indicative of the expected development of the company Biotest AG and are summarized as follows:
Taking into consideration the revenue declines with affiliated companies, the Board of Management expects for the financial year 2025 that the revenues will reduce in the mid‐single‐digit percentage range compared to 2024. This effect is countered by the higher revenue level resulting from the ramp‐up of the Yimmugo® production facilities within Biotest Next Level. The Board of Management does not rule out negative revenue trends due to potential cyclical reductions in demand, global disputes, the introduction of punitive tariffs, and country‐specific savings in the healthcare sector.
Accordingly, the Board of Management expects an operating result (EBIT) in the range of € ‐55.0 million to € ‐75.0 million for the 2025 financial year, which will be below that of the 2024 financial year. As a result, the Board of Management expects a lower return on capital employed (RoCE) of ‐3 to ‐7 % compared to the 2024 financial year, along with a positive cash flow from operating activities that is expected in the negative triple‐digit million range and below the prior year´s level.
The Biotest Group aims to maintain a balanced financing structure in terms of the ratio of debt to equity as well as short‐term to long‐ term credit financing. The majority of the cash and cash equivalentsreceived in recent years have been used by the Group for the Biotest Next Level project and will continue to be used to ensure the ramp‐up of the production facility. Additionally, Biotest has expanded its network of plasma collection centers to ensure, among other things, the necessary plasma supply for the new Biotest Next Level pro‐ duction facility with European plasma. For the 2025 financial year, Biotest AG plans to invest at the same level as in the previous year. The major portion of these investments will go towards the expansion and maintenance of production facilities and infrastructure measures at the Dreieich site in Germany. Furthermore, investments will be made in developments in the area of digitalisation.
Financing in 2024 was mainly provided by shareholder loans and further external financing sources. Due to these financing sources, which are available to Biotest AG on a long‐term basis, and the contractual financing commitment from Grifols, S.A., the financing re‐ quirements for the ramp‐up of the Biotest Next Level production facility and other R&D activities are secured.
H.XII. STATEMENT CONCERNING THE DEPENDENT COMPANY REPORT PURSUANT TO SECTION 312 AKTG
Concluding statement concerning the Board of Management's report on relations with affiliated companies pursuant to Section 312 of the German Stock Corporation Act (AktG).
Pursuant to Section 312 (1) AktG, the Board of Management of Biotest AG has prepared a Board of Management report on relationships with affiliated companies, which contains the following concluding statement:
"Biotest AG received appropriate consideration for each of the legal transactions listed in the report on relationships with affiliated companies according to the circumstances known to the Board of Management at the time the legal transactions were conducted. No other reportable measures in the meaning of Section 312 AktG arose in the reporting period."
Dreieich, 24 March 2025
Peter Janssen Chairman of the Board of Management
> CONSOLIDATED FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF INCOME
of the Biotest Group for the period from 1 January to 31 December 2024
| in € million | Note | 2024 | 2023 |
|---|---|---|---|
| Revenue | D 1 | 726.2 | 684.6 |
| Cost of sales | –502.4 | –404.3 | |
| Gross profit | 223.8 | 280.3 | |
| Other operating income | D 5 | 8.4 | 26.9 |
| Marketing and sales costs | –49.9 | –50.4 | |
| Administrative expenses | –38.4 | –30.6 | |
| Research and development costs | D 4 | –56.8 | –66.8 |
| Other operating expenses | D 6 | –0.5 | –16.0 |
| Impairment losses and gains (including reversals of impairment losses) on financial assets and contract assets |
E 8 | 7.9 | 0.1 |
| Operating result | 94.5 | 143.5 | |
| Financial income | D 7 | 9.9 | 9.7 |
| Financial expenses | D 8 | –43.8 | –49.7 |
| Financial result | –33.9 | –40.0 | |
| Result from joint ventures | D 9 | –14.1 | 2.8 |
| thereof regular share of profit (loss) from investment | –4.4 | 2.8 | |
| thereof impairment loss on investment | –9.7 | – | |
| Profit (+)/ loss (‐) before taxes | 46.5 | 106.3 | |
| Income taxes (expenses (‐); previous year income (+)) | D 10 | –20.2 | 20.7 |
| Profit (+)/ loss(‐) for the period | 26.4 | 127.0 | |
| Attributable to: | |||
| Equity holders of the parent | 26.4 | 127.0 | |
| Earnings per ordinary share in € | E 12 | ||
| basic earnings per ordinary share | 0.66 | 3.20 | |
| diluted earnings per ordinary share | 0.66 | 3.20 | |
| Additional dividend rights per preference share in € | E 12 | 0.02 | 0.02 |
| Earnings per preference share in € | E 12 | ||
| basic earnings per preference share | 0.68 | 3.22 | |
| diluted earnings per preference share | 0.68 | 3.22 |
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
of the Biotest Group for the period from 1 January to 31 December 2024
| in € million | 2024 | 2023 |
|---|---|---|
| Profit (+)/ loss (‐) for the period | 26.4 | 127.0 |
| Exchange difference on translation of foreign operations | 4.2 | 2.8 |
| Reclassification of foreign currency translation differences recognised in the statement of income | – | 0.3 |
| Reclassification of the deconsolidation effect in the statement of income | – | –0.3 |
| Other comprehensive income, net of tax, to be reclassified to profit or loss in subsequent periods |
4.2 | |
| 2.8 | ||
| Remeasurement of defined benefit plans (see E 13) | 3.2 | –2.8 |
| resulting income tax effect | –0.2 | 0.8 |
| Other comprehensive income, net of tax, not to be reclassified to profit or loss in subsequent periods | 3.0 | –2.0 |
| Other comprehensive income, net of tax | 7.2 | 0.8 |
| Total comprehensive income, net of tax | 33.6 | 127.8 |
| Attributable to: | ||
| Equity holders of the parent | 33.6 | 127.8 |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
of the Biotest Group as of 31 December 2024
| in € million | Note | 31 December 2024 | 31 December 2023 |
|---|---|---|---|
| ASSETS | |||
| Non‐current assets | |||
| Intangible assets | E 1 | 16.5 | 15.0 |
| Property, plant and equipment | E 2 | 514.9 | 522.4 |
| Right‐of‐use assets from leases | E 3 | 55.9 | 56.0 |
| Investments in joint ventures | E 4 | 2.1 | 11.3 |
| Other assets | E 10 | 0.2 | 0.1 |
| Other financial assets | E 5 | 15.4 | 16.7 |
| Deferred tax assets | E 6 | 19.5 | 32.9 |
| Total non‐current assets | 624.5 | 654.4 | |
| Current assets | |||
| Inventories | E 7 | 479.5 | 419.1 |
| Contract assets | E 9 | 36.0 | 51.6 |
| Trade receivables | E 8 | 157.9 | 145.2 |
| Current income tax assets | 1.8 | – | |
| Other assets | E 10 | 12.6 | 21.2 |
| Other financial assets | E 5 | 13.9 | 11.3 |
| Cash and cash equivalents | E 11 | 107.8 | 108.1 |
| Total current assets | 809.5 | 756.5 | |
| Total assets | 1,434.0 | 1,410.9 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Subscribed Capital | 39.6 | 39.6 | |
| Share premium | 219.8 | 219.8 | |
| Retained earnings | 274.5 | 249.8 | |
| Other reserves | –3.2 | –10.3 | |
| Equity attributable to equity holders of the parent | E 12 | 530.7 | 498.9 |
| Total equity | E 12 | 530.7 | 498.9 |
| Non‐current liabilities | |||
| Provisions for pensions and similar obligations | E 13 | 91.7 | 91.1 |
| Other provisions | E 14 | 13.8 | 4.8 |
| Financial liabilities | E 15, E 3 | 635.9 | 429.7 |
| Other liabilities | E 16 | 0.7 | – |
| Deferred tax liabilities | E 6 | 1.1 | 1.1 |
| Total non‐current liabilities | 743.2 | 526.7 | |
| Current liabilities | |||
| Other provisions | E 14 | 18.2 | 23.1 |
| Current income tax liabilities | 1.1 | 0.9 | |
| Financial liabilities | E 15, E 3 | 35.9 | 260.1 |
| Trade payables | 88.4 | 78.1 | |
| Other liabilities | E 16 | 14.0 | 22.9 |
| Contract liabilities | 2.5 | 0.2 | |
| Total current liabilities | 160.1 | 385.3 | |
| Total liabilities | 903.3 | 912.0 | |
| Total equity and liabilities | 1,434.0 | 1,410.9 |
CONSOLIDATED STATEMENT OF CASH FLOWS
of the Biotest Group for the period from 1 January to 31 December 2024
| in € million | Note | 2024 | 2023 |
|---|---|---|---|
| Profit (+)/ loss (‐) for the period | 26.4 | 127.0 | |
| Tax expense (previous year income) | 20.2 | –20.7 | |
| Depreciation, amortisation and impairment of intangible assets, property, plant, | |||
| equipment and rights of use | E 1; E 2; E 3 | 40.6 | 35.9 |
| Reversal of write‐downs on inventories (previous year: write‐downs)* | E 7 | –37.7 | 47.7 |
| Reversal (‐) of /and impairment (+) of financial assets | E8 | –7.9 | – |
| Other non‐cash income and expense items | – | –1.9 | |
| Gain on disposal of subsidaries | – | –23.1 | |
| Losses / Gains from joint ventures | D 9 | 14.0 | –2.4 |
| Losses from the disposal of property, plant and equipment | –0.1 | – | |
| Changes in pension provisions | E 13 | 0.7 | –0.8 |
| Financial result | D 7; D 8 | 33.9 | 40.0 |
| Operating cash flow before changes in working capital | 90.1 | 201.7 | |
| Changes in other provisions | E 14 | 4.2 | –0.4 |
| Changes in inventories, receivables and other assets | –11.4 | –213.4 | |
| Changes in trade payables and other liabilities | 7.0 | 45.3 | |
| Cash flow from changes in working capital | –0.2 | –168.5 | |
| Interest paid | –20.3 | –24.2 | |
| Taxes paid | –8.7 | –11.7 | |
| Cash flow from operating activities | 60.9 | –2.7 | |
| Payments for investments in intangible assets and property, plant and equipment | –28.7 | –33.4 | |
| Proceeds from the disposal of property, plant and equipment | 0.2 | 1.0 | |
| Proceeds from the disposal of subsidiaries | B 1 | – | 35.0 |
| Interest received | 1.1 | 1.1 | |
| Proceeds (+)/ payments (‐) for investments in other financial assets | 1.7 | –2.4 | |
| Cash flow from investing activities | –25.7 | 1.3 | |
| Dividend payments for the previous year | E 12 | –1.6 | – |
| Other payments / proceeds from financing activities | E 5; E 11 | –1.0 | 2.1 |
| Proceeds from the assumption of financial liabilities | E 15 | 197.4 | 10.1 |
| Payments for the redemption of financial liabilities | E 15 | –225.1 | –12.0 |
| Payments for redemption portion of lease liablities | –5.1 | –7.0 | |
| Cash flow from financing activities | –35.4 | –6.8 | |
| Cash changes in cash and cash equivalents | –0.2 | –8.2 | |
| Exchange rate‐related changes in cash and cash equivalents | –0.1 | 0.1 | |
| Consolidation group‐related changes in cash and cash equivalents | – | –0.4 | |
| Cash and cash equivalents on 1 January | E 11 | 108.1 | 116.6 |
| Cash and cash equivalents on 31 December | E 11 | 107.8 | 108.1 |
* In the previous year, the write‐down of inventories was reported in the cash flow statement under the inventories item. For the financial year 2024, it was reclassified to the item "Reversal of write‐downs on inventories/write‐downs", which is included in the operating cash flow before changes in working capital.
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
of the Biotest Group for the period from 1 January to 31 December 2024
| in € million | Subscribed capital |
Share premium |
Retained earnings |
Remeasurem ent of defined benefit plans |
Translation reserve |
Total equity |
|---|---|---|---|---|---|---|
| As of 1 January 2023 | 39.6 | 219.8 | 123.2 | –9.5 | –2.0 | 371.1 |
| Reclassification to income statement | – | – | –0.3 | – | 0.3 | – |
| Other comprehensive income after taxes | – | – | – | –2.0 | 2.8 | 0.8 |
| Profit (+)/ loss(‐) for the period | – | – | 127.0 | – | – | 127.0 |
| Total comprehensive income | – | – | 126.7 | –2.0 | 3.1 | 127.8 |
| Dividend payments | – | – | – | – | – | – |
| As of 31 December 2023 | 39.6 | 219.8 | 249.8 | –11.5 | 1.1 | 498.9 |
| As of 1 January 2024 | 39.6 | 219.8 | 249.8 | –11.5 | 1.1 | 498.9 |
| Other comprehensive income after taxes | – | – | – | 3.0 | 4.2 | 7.2 |
| Profit (+)/ loss(‐) for the period | – | – | 26.4 | – | – | 26.4 |
| Total comprehensive income | – | – | 26.4 | 3.0 | 4.2 | 33.6 |
| Dividend payments | – | – | –1.6 | – | – | –1.6 |
| As of 31 December 2024 (see E 12) | 39.6 | 219.8 | 274.5 | –8.5 | 5.3 | 530.7 |
NOTES FOR THE FINANCIAL YEAR 2024
A. GENERAL INFORMATION
The Biotest Group consists of the parent company, Biotest Aktiengesellschaft (Biotest AG) with its registered office in Dreieich, Ger‐ many, and its domestic and foreign subsidiaries. The parent company's headquarters are located at Landsteinerstraße 5, 63303 Dreieich, Germany. Biotest AG is registered in the commercial register of the District Court of Offenbach am Main under commercial register sheet number 42396. Biotest is a provider and developer of biological and biotechnological pharmaceutical products. With a value‐added chain that ranges from preclinical and clinical development through to worldwide marketing and distribution, Biotest specialises primarily in the therapeutic areas of clinical immunology, haematology, and intensive care medicine.
Error correction in accordance with IAS 8.41 et seq.
The review of the Biotest Group's reporting and management structure has led to a change in segment reporting in accordance with the provisions of IFRS 8. The company carries out a single business activity, which is determined by the special features of the pro‐ duction process, so that ‐ unlike in the previous year's financial statements ‐ it is not possible to determine several operating seg‐ ments in accordance with IFRS 8.5 and the Biotest Group is instead a single‐segment company. Accordingly, the chief operating decision maker (CODM) decides on the allocation of resources at overall company level and also manages the company in this way. With regard to the adjusted segment reporting for the previous year and further explanations in this regard, please refer to our comments in section C. Segment reporting. In the previous year, goodwill was already tested for impairment at the level of the company as a whole, which is considered appropriate in connection with the correction of segment reporting. Please refer to the notes Intangible assets B 4 and E 1.
As part of the consolidated financial statement disclosures, an adjustment was made regarding the presentation of impairments on trade receivables from the previous year. The affected positions were presented correctly in the comparative period and the prior year within the primary financial statement components. For further details, we refer to section E8 Trade Recievables.
The Biotest Group employed 2,495 full‐time equivalents worldwide as of the reporting date (previous year: 2,426).
The financial statements of Biotest AG and its subsidiaries have been prepared in accordance with the International Financial Re‐ porting Standards (IFRS) that are mandatory in the European Union. IFRS include the International Financial Reporting Standards (IFRS), the International Accounting Standards (IAS), and the interpretations of the International Financial Reporting Standards In‐ terpretations Committee (IFRIC) and the Standing Interpretation Committee (SIC). The Biotest Group's financial accounting policies are based on IFRS whose application is mandatory for financial years beginning on 1 January 2024.
The financial year for all companies included in the Group corresponds to the calendar year. For the period from 1 January to 31 December 2024, all companies, with the exception of the joint venture, are included on the basis of their financial statements as of 31 December 2024. The joint venture is recognised at equity, based on the previous year's financial statements.
The consolidated financial statements in their current version comply with Section 315e of the German Commercial Code (HGB). In Germany, this forms the legal basis for consolidated accounting in accordance with international standards in conjunction with Reg‐ ulation (EC) no. 1606/2002 concerning the application of International Accounting Standards issued by the European Parliament and Counsel on 19 July 2002.
Unless indicated otherwise, all amounts are stated in millions of euros (€ million). The financial statements have been prepared in euros.
Due to the presentation in millions of euros, rounding differences of +/‐ one decimal place may occur when summing the amounts shown. The visual indicator "‐" signifiesthat no value existsfor thisitem. A value of +/‐ 0.0 indicatesthat a value exists but is displayed as 0.0 due to rounding.
The chosen masculine form always also refers equally to female or diverse persons. Due to better legibility, we have refrained from using consistent double designations. The consolidated financialstatements have been prepared based on the assumption of a going concern. In the opinion of the management, there are no material uncertainties regarding the company's ability to continue its business activities in the foreseeable future. This assessment is based on the current financial position, the liquidity planning and the available sources of financing.
The Board of Management of Biotest AG prepared the consolidated financial statements as of 24 March 2025, and submitted them to the Supervisory Board for approval and review.
CHANGES IN ACCOUNTING POLICIES
The accounting policies applied are consistent with those of the previous year. Newly applicable standards had no material impact on the consolidated financial statements.
Adjustments in the 2024 financial year relate to the change in the plasma distribution key for the allocation of manufacturing costs to co‐products (change in accounting estimate, see Inventories, E 7), the change in the presentation of reversal of write‐downs on inventories in the cash flow statement (see Inventories, E 7).
Impairment losses and gains (including reversals of impairment losses) on financial assets and contract assets are reported as a separate income statement item within the operating result using a uniform measurement and disclosure approach. The change in presentation is made in accordance with the rules of IAS 1.41 to improve the presentation of the results of operations for both the financial year and the comparative period. In the previous year, impairment losses and gains (including reversals of impairment losses) on financial assets and contract assets were reported net under other operating income. Please refer to our comments in section D 5 Other operating income.
Other standards
The following amended standards and interpretations recognised by the EU had no material effects on the consolidated financial statements in the first year of adoption in 2024:
- Amendments to IAS 1: Classification of Liabilities as Current or Non‐current
- Amendments to IAS 1: Classification of Liabilities with Covenants
- Amendments to IAS 7 and IFRS 7: Disclosure of Supplier Finance Arrangements
- Amendments to IFRS 16: Lease Liability in a Sale and Leaseback
The IASB has published the standards and interpretations listed below, which were not yet mandatory in the 2024 financial year. On the basis of a preliminary assessment, it is expected that IFRS 18 Presentation and Disclosure in Financial Statements, in particular, which is expected to be applicable from the 2027 financial year, could have a significant impact on the Group's financial accounting and reporting. In accordance with IAS 8.30, it is currently assumed that the application of IFRS 18 is likely to have a significant impact on the consolidated financial statements. The final assessment and implementation takes place as part of ongoing financial account‐ ing processes. Except for IFRS 18, based on current knowledge, Biotest does not expect the application of the standards, interpreta‐ tions and amendments listed below to have a significant impact.
• Amendments to IAS 21: Lack of Exchangeability of a Currency
- Amendments to IFRS 7 and IFRS 9: Contracts Referencing Nature‐dependent Electricity (endorsement pending)
- Amendments to IFRS 9 and IFRS 7: Classification and Measurement of Financial Instruments (endorsement pending)
- Amendments to IAS 7, IFRS 1, IFRS 7, IFRS 9, and IFRS 10: Annual Improvements to IFRS Volume 11 (endorsement pending)
- IFRS 18: Presentation and Disclosure in Financial Statements (endorsement pending)
- IFRS 19: Subsidiaries without Public Accountability: Disclosures (endorsement pending)
B. SIGNIFICANT ACCOUNTING AND VALUATION PRINCIPLES
B 1 SCOPE OF CONSOLIDATION
The consolidated financial statements of Biotest AG include three (previous year: three) domestic and seven (previous year: seven) foreign companies in which Biotest AG directly or indirectly holds a majority of the voting rights.
BioDarou P.J.S. Co., based in Tehran, Iran, is included in the consolidated financial statements at equity as a joint venture.
An overview of the participating interests of Biotest AG as defined by section 313 (2) HGB is provided in section F 9 List of sharehold‐ ings.
Grifols Biotest Holdings GmbH, Frankfurt am Main, Germany, holds the majority of the voting rights in Biotest AG. The Biotest Group isincluded in the consolidated financialstatements of Grifols, S.A., Barcelona, Spain, which, asthe Group's ultimate parent company, also preparesthe consolidated financialstatementsfor the largest and smallest consolidated group. The consolidated financialstate‐ ments of the ultimate parent company for the smallest and largest consolidated group can be obtained at the registered office of the parent company, Grifols, S.A., Barcelona, Spain.
B 2 CONSOLIDATION METHODS
The closing date for Biotest AG and all companies included in the financial statements is 31 December 2024. The consolidated com‐ panies' financial statements were prepared applying uniform accounting policies as prescribed by Biotest AG.
Intragroup revenue, expenses, and income, as well as all receivables and liabilities between consolidated companies, have been eliminated.
The Group controls an investee in particular and only if it exhibits all of the following characteristics:
- power over the investee (that is, the Group has the ability on the basis of existing rights to direct those activities of the investee that significantly affect its returns),
- a risk exposure due to or rights to variable returns from its interest in the investee, and
- the ability to use its power over the investee to affect the amount of the investor's returns.
If the Group does not hold a majority of the voting rights or similar rights in the investee, it takes all facts and circumstances into consideration in assessing whether it has power over this investee. These include:
- contractual arrangements with other holders of voting rights,
- rights arising from other contractual arrangements,
- voting rights and potential voting rights of the Group.
A subsidiary is consolidated from the date on which the Group gains control of the subsidiary. It is deconsolidated if the Group loses control of the subsidiary. Assets, liabilities, income, and expenses of a subsidiary acquired or disposed of during the reporting period are recognised in the statement of financial position and statement of comprehensive income from the date on which the Group acquires control of the subsidiary until the date on which control ends.
Any change in the ownership interest in a subsidiary that does not result in a loss of control is accounted for as an equity transaction. If a parent company loses control of a subsidiary, the associated assets (including goodwill), liabilities, non‐controlling interests, and other equity components are derecognised. Any resulting profit or loss is taken into consideration in the statement of income. Any retained investment is recognised at fair value.
Business combinations are consolidated using the purchase method in accordance with IFRS 3. Under this method, the cost of a business combination is measured as the sum of the consideration transferred, measured at fair value on the acquisition date. Inci‐ dental acquisition costs incurred in connection with the business combination are recognised as other operating expenses.
A joint venture is a joint arrangement whereby the parties that have joint control have rights to the net assets of the arrange‐ment. Investments in joint ventures are recognised using the equity method in accordance with IAS 28. Under the equity method, invest‐ ments are recognised on the statement of financial position at cost plus post‐acquisition changes in the share held by the Group in the net assets of the equity accounted company.
The Group'sshare ofthe profit orlossfrom the joint venture isreported separately in profit orlossforthe period. Changesrecognised directly in the equity of the joint venture are recognised by the Group in the amount of its share and, where appropriate, are pre‐ sented in the consolidated statement of changes in equity. Goodwill arising on the acquisition of a joint venture is included in the carrying amounts of joint ventures and is neither amortised nor tested for impairment separately.
After applying the equity method, the Group determines whether it is necessary to record an additional impairment on inter‐ests in joint ventures. On each reporting date, the Group determines whether objective evidence exists that interests in a joint venture are impaired. If this is the case, the difference between the fair value of the investment and the carrying amount of the investment is recognised as an impairment loss in the consolidated income statement.
B 3 CURRENCY TRANSLATION
The functional currency concept appliesto currency translation. The subsidiariesincluded in the Biotest Group conduct their business independently, and the functional currency of these companiesis consequently the respective local currency. Transactions in foreign currencies are translated into the respective functional currency of the Group companies at the spot rate on the transaction date. When translating the annual financial statements of subsidiaries whose functional currency is not the euro, assets and liabilities are translated using the mean rate of exchange prevailing as of the reporting date, and income and expenses are translated at the average annual rate. The resulting accumulated differences are recognised in other comprehensive income, that is, in a separate item in equity, which is disclosed under retained earnings on the statement of financial position.
In accordance with IAS 21, goodwill relating to assets of economically independent foreign subsidiaries is translated at the closing rate.
In the reporting period, due to inflationary developments in Iran, the provisions of IAS 29 Financial Reporting in Hyperinflationary Economies were applied for the first time to the joint venture based there. In this context, please see our comments in section E 4.
| Average exchange rates | ||||
|---|---|---|---|---|
| 1 euro equals | 2024 | 2023 | 31.12.2024 | 31.12.2023 |
| USD | 1.0821 | 1.0816 | 1.0389 | 1.1050 |
| CHF | 0.9526 | 0.9717 | 0.9412 | 0.9260 |
| CZK | 25.1190 | 24.0006 | 25.1850 | 24.7240 |
| HUF | 395.4220 | 381.7600 | 411.3500 | 382.8000 |
| BRL | 5.8268 | 5.4016 | 6.4253 | 5.3618 |
The following exchange rates were applied to currency translation within the Biotest Group:
Monetary items (cash and cash equivalents, receivables, and liabilities) denominated in foreign currency in the consolidated compa‐ nies' individual statements of financial position are recognised in local currency at the closing rate. Income and expenses resulting from currency translation are reported as financial expense or financial income.
B 4 INTANGIBLE ASSETS
A) GOODWILL
Goodwill arises from the acquisition of companies or interests in companies and represents the difference between the cost of acquisition (acquisition price) and the fair values of the assets and liabilities acquired. Goodwill is recognised at the acquisition cost. In accordance with IAS 36, the cash‐generating unit to which goodwill has been allocated is tested for impairment annually, and whenever an indication exists that the value of the unit may be impaired, by comparing the carrying amount of the unit, including goodwill, with the recoverable amount.
The Biotest Group allocates goodwill to a single cash‐generating unit (CGU), which comprises the entire company. In the previous year, the impairment test for goodwill was carried out at the Group level. As goodwill may be tested at maximum at the level of an
operating segment in accordance with IFRS 8.5 (IAS 36.80(b)), it was not tested correctly in the context of the previous year'ssegment reporting. With the correction of the error in the segment reporting, the impairment test for goodwill is now also being carried out correctly at the level of the company as a whole. Please refer to the notes Intangible assets B 4 and E 1.
In cases where goodwill represents a portion of the cash generating unit, and a part of the business division of this unit is divested, goodwill attributable to the divested business division is included in the carrying amount of the business division when determining the gain on the divestiture of the division. The value of the divested portion of goodwill is determined on the basis of the relative values of the divested business and the remaining portion of the cash generating unit.
An impairment loss is recognised through profit or loss if the recoverable amount of the cash generating unit is lower than the carrying amount. The recoverable amount is the maximum of fair value, less costs to sell, and value in use. For the purpose of im‐ pairment testing, the allocable future cash flows of the cash generating units are used to calculate their value in use on the basis of the discounted cash flow method. Under this method, cash flows are discounted based on multi‐year business projections and a long‐term growth rate forecast. The growth rate depends on the business under review. The discount rates applied before tax are based on the relevant WACC (Weighted Average Cost of Capital). Any write‐downs required are determined by comparing the car‐ rying amount of the cash generating unit with the recoverable amount. To determine the recoverable amount in accordance with IAS 36, the value in use (VIU) is calculated first. This is based on an appropriate valuation model that discounts future cash flows. The calculation is carried out in accordance with the requirements of IAS 36, taking into account assumptions regarding future income, growth rates and an appropriate discount rate. In addition, fair value less costs of disposal (FVLCD) is used as a secondary indicator. FVLCD follows the valuation principles of IFRS 13 and can be based on external market prices or determined by an objectified DCF valuation. In the Biotest Group, the share price at the reporting date serves as an indicator of fair value. The recoverable amount corresponds to the higher of the two values of value in use (VIU) and fair value less costs of disposal (FVLCD).
B) CAPITALISED DEVELOPMENT COSTS
Expenditure on research activities is expensed as incurred.
Development expenditure is capitalised only if the development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Group has both the intention and suffi‐cient resources to complete development and to use or sell the asset. Other development expenditures are expensed as in‐curred. Capitalised devel‐ opment expenditure is measured at cost less accumulated amortisation and accumulated impairment losses.
Capitalised development expenditures are amortised on a straight‐line basis over their estimated useful lives. Amortisation is gen‐ erally recognised in profit or loss.
The estimated useful life of capitalised development costs is 20 years.
Intangible assetsthat are not yet available for use are tested for impairment at least annually as well as whenever an indication exists that they may be impaired.
C) OTHER INTANGIBLE ASSETS
Other intangible assets acquired are recognised at cost and exclusively include assets with a finite useful. Assets with a finite useful life are amortised on a straight line basis overtheir estimated useful life. If necessary, impairment losses are recognised in accordance with IAS 36. The recognised useful lives are estimated as follows:
| Patents and rights | 20 years |
|---|---|
| Software | 3 years |
The amortisation period and the amortisation method applied to an intangible asset with a finite useful life are reviewed at least at the end of every financial year. If a change occurs in the anticipated useful life of the asset or anticipated amortisation period of the asset, another amortisation period or amortisation method is to be selected. Such changes are treated as changes to estimates. Amortisation of intangible assets with a finite useful life is recorded in the income statement under the expense category corre‐ sponding to the intangible asset's function.
Impairment testing is performed on the basis of the allocated future cash flows; to test impairment, their recoverable amount is calculated as the value in use using the discounted cash flow method. Under this method, cash flows are discounted based on multi‐ year business projections and a long‐term growth rate forecast. The growth rate depends on the business under review. The discount rates applied before tax are based on the relevant WACC (Weighted Average Cost of Capital). Any write‐downs required are deter‐ mined by comparing the carrying amount of the intangible assets with the recoverable amount.
B 5 PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment is recognised in accordance with the cost of purchase model at the cost of purchase or produc‐tion cost less accumulated depreciation and accumulated impairment losses. Depreciation is allocated on a straight‐line basis over the expected useful life, which is estimated as follows:
| Buildings | up to 50 years |
|---|---|
| Technical equipment and machinery | 5 – 25 years |
| Other, operating and office equipment | 3 – 14 years |
If necessary, an impairment loss is recognised in accordance with IAS 36, if there are indications that this may have occurred. If impairment is indicated, the carrying amounts of property, plant and equipment are compared against the corresponding recovera‐ ble amounts.
Production costs for self‐constructed property, plant and equipment include material and personnel costs as well as an appropriate share of overhead costs. Ongoing repair and maintenance expenses are recognised in profit or loss when incurred. Extensions and material improvements are capitalised. Interest on borrowed funds is recognised as an expense provided it is not applicable to the production of qualified assets in accordance with IAS 23. Government grants reduce the costs of purchase or production costs.
The depreciation method selected, the useful life, and the assumed residual value of property, plant and equipment are reviewed on each reporting date and adjusted if necessary.
B 6 LEASES
A lease is an agreement that transfers the right to use an asset for an agreed period of time in return for payment. The Biotest Group concludesleasing agreements with partners outside the Group only in the function of lessee. Given this, only the ac‐counting policies relevant from the lessee's perspective are presented below.
For all leases, as a matter of principle, Biotest Group, as the lessee, recognises right‐of‐use assets for the leased assets and liabili‐ties for the related payment obligations at present values on the statement of financial position. For those contracts that contain non‐ leasing components in addition to leasing components, only the leasing components are treated in accordance with IFRS 16. Non‐ leasing components are expensed.
The valuation of lease liabilities includes the following leasing payments:
- Fixed payments (less leasing incentives to be provided by the lessor)
- Variable payments linked to an index or interest rate
Payment obligations arising from residual value guarantees, from the exercise of purchase options deemed reasonably certain, and from penalties in the event of termination are not relevant for the Biotest Group's leases.
The lease liability is initially recognised at the present value of the lease payments not yet paid at the start of the lease, and dis‐ counted using the interest rate underlying the lease. If this interest rate cannot be readily determined, the Group applies its incre‐ mental borrowing rate.
The incremental borrowing rate depends on the term, currency, and commencement date of the lease, and is determined on the basis of various factors. This is the interest rate that the lessee would have to pay if it were to take out a loan with a comparable term and comparable collateral in order to obtain the funds to acquire an asset in a comparable economic environment. As a basis for determining the incremental borrowing rate, the Biotest Group utilises base interest rates with matching maturities, including premiums for country risks and currency risks.
Rights of use are valued at acquisition cost, which are composed as follows:
- Lease liability,
- lease payments made at or before deployment, less lease incentives received,
- initial direct costs, and
- dismantling obligations.
Subsequent measurement is at amortised cost. Rights of use are amortised on a straight‐line basis over the period of the con‐tractual relationship.
For leased assets of low value and for short‐term leases (less than twelve months), use is made of simplified application options and the payments are expensed on a straight‐line basis. Furthermore, IFRS 16 is not applied to leases of intangible assets.
The Biotest Group determines the term of the lease on the basis of the non‐cancellable period and of all contractually agreed exten‐ sion and cancellation options. Such options are only taken into consideration if their exercise or non‐exercise is deemed sufficiently certain.
When assessing the term of leases, the Group in principle uses a planning horizon of five years, within which a reliable estimate of the exercise of extension or cancellation options is possible. Extension options are included in the lease term if it can be assumed with reasonable certainty that they will be exercised. Cancellation options are also taken into consideration if it is reasonably certain that they will not be exercised.
If a longer contractual term has been contractually agreed, as may be the case for significant Group properties, this longer term is taken as the basis. Decisions concerning the exercise or non‐exercise of options are made on the basis of the following factors:
- Economic incentives (such as favourable contractual conditions or strategic importance of the asset);
- Costs of potential replacement;
- Availability of alternative assets.
If the original assessment changes, such as due to changes in economic circumstances or strategic decisions, the term of the lease is adjusted accordingly, and both the right‐of‐use assets and the lease liabilities are remeasured.
B 7 IMPAIRMENT
Should facts or circumstances indicate a need for impairment of durable assets or should an annual impairment test of an asset be required, the recoverable amount, which represents the higher of either the net realisable value or value in use, is calculated.
The recoverable amount is calculated for each individual asset, unless the asset does not generate cash flows that are independent (to the greatest extent possible) of cash flows from other assets or other groups of assets.
To calculate value in use, the estimated future cash flows are discounted to their present value at a pretax discount rate reflecting current market expectations with regard to the interest rate effect and the specific risks of the asset.
If the recoverable amount is lower than the carrying amount, the value of the asset is considered impaired and is written down to the recoverable amount.
Impairment expenses are recognised in the expense categories corresponding to the function of the impaired asset.
Interests in joint ventures are recognised using the equity method in accordance with IAS 28. If indications of impairment exists (triggering eventsin accordance with IAS 36.12), an impairment test is conducted in accordance with IAS 36. The recoverable amount is determined as the higher of fair value less costs to sell and value in use.
With the exception of goodwill, impairment losses are reversed up to a maximum of amortised cost if estimates for the recoverable amount exceed the carrying amount.
B 8 INVENTORIES
Inventories are recognised at the lower of cost or net realisable value as of the reporting date. The latter corresponds to the esti‐ mated selling price that may be recovered in the course of ordinary business, less expected completion or selling costs. Production costs are calculated using the weighted average method. In addition to directly allocable individual costs, pursuant to IAS 2, produc‐ tion costsinclude an appropriate share of overhead costs directly allocable to the production process. These are based on the normal capacity of the manufacturing plants excluding borrowing costs.
In the 2024 financial year, a change in estimates was made by reallocating raw material costs to end products (Intratect®, Human albumin and Haemoctin® (Factor VIII)). The change is based on new commercial findings and takes updated cost and sales volume analyses into consideration. The change in estimate represents an appropriate allocation of raw material costs in line with the prod‐ ucts' cost‐bearing capacity in order to ensure allocation in line with market and costs. The amendment represents a change in ac‐ counting estimates in accordance with IAS 8 and was applied prospectively; the previous year's figures remain unchanged.
B 9 CONTRACT ASSETS AND CONTRACT LIABILITIES
Contract assets from toll manufacturing resulting from the application of the percentage of completion method are reported net of prepayments received if the production costs already incurred, including the share of profits, exceed the prepayments received.
A contract liability is an obligation of an entity to transfer goods or services to a customer for which it has received considera‐tion from the customer. Contract liabilities from licensing agreements are recognised in the amount in which Biotest has already received prepayments for an obligation to render services to a customer in the future. Licence revenues are recognised with the delivery of the products at a specific point in time.
B 10 PENSION PROVISIONS
The Biotest Group has several defined contribution and defined benefit pension plans.
Commitments under defined contribution plans are determined by contributions to be made in the period, so that in this case no actuarial assumptions are required.
In the case of defined benefit plans, the cost of providing benefits is calculated using the projected unit credit method, whereby an actuarial valuation is compiled on each reporting date. Remeasurements consisting of actuarial gains and losses, changes resulting from the application of the asset ceiling, and the return on plan assets (excluding interest on the net liability) are recognised directly in other comprehensive income. The revaluations recognised in other comprehensive income form part of other reserves, and are no longer reclassified to the income statement.
Past service cost that arises in a given financial year due to a retroactive change in pension commitments is expensed when the plan amendment or curtailment occurs or, if earlier, when the Biotest Group recognises the associated restructuring costs or severance payments. Gains or losses from the settlement of a defined benefit plan are recognised at the time of settlement.
B 11 OTHER PROVISIONS
In accordance with IAS 37, provisions are recognised when a present (legal or constructive) obligation exists arising from of a past event, it is probable that this will result in an outflow of resources to settle the obligation, and a reliable estimate can be made of the outflow of resources. Provisions are measured at the most probable amount. Provisions with an expected time for settlement of more than twelve months after the reporting date are recognised at their present value.
Provisions are discounted using a pre‐tax interest rate reflecting the risks that specific to the liability. Increases in provisions due to the passage of time are recorded as interest expense.
B 12 FINANCIAL INSTRUMENTS
A financial instrument is a contract that results in a financial asset for one company and a financial liability or equity instrument for another company.
Financial assets
Financial assets comprise cash and cash equivalents, cash deposits with banks,trade receivables, loansto third parties, otherfinancial receivables, and derivative financial assets held for trading.
Cash and cash equivalents comprise cash and current account balances, cheques, and short‐term realisable financial assets with original terms of less than three months and are carried at their nominal value.
Financial assets are measured at fair value on initial recognition, with the exception of trade receivables without a significant financ‐ ing component, which are measured at the transaction price. Receivables denominated in foreign currencies are translated at the closing rate. Any resultant foreign exchange rate loss or gain is recognised in profit or loss.
Transaction coststhat are directly attributable to the acquisition of financial assetsthat are not measured at fair value through profit or loss increase the fair value of the financial assets upon addition. Transaction costs that are directly attributable to the acquisition of financial assets measured at fair value through profit or loss are recognised immediately in profit or loss.
Financial assets are recognised and derecognised on the trade date if they are financial assets whose delivery occurs within the usual time frame for the market concerned.
All recognised financial assets are subsequently measured in their entirety either at amortised cost or at fair value, depending on the classification of the financial assets.
Classification of financial assets
The Group classifies financial assets as follows:
Debt instruments that meet both of the following conditions are measured at amortised cost:
- The financial asset is held as part of a business model whose objective is to collect the contractual cash flows;
- The contractual terms of the financial asset represent solely interest and principal payments on the outstanding nominal amount.
Debt instruments that fulfil both of the following conditions are measured at fair value through other comprehensive income:
- The financial asset is held as part of a business model whose objective is both the collection of contractual cash flows as well as the sale of financial assets;
- The contractual terms of the financial asset represent solely interest and principal payments on the outstanding nominal amount.
All other financial assets that do not fulfil the above conditions are measured at fair value through profit or loss, as a matter of principle.
Measurement of financial assets
Financial assets measured at amortised cost (debt instruments):
The most significant category of financial assets for the Biotest Group is the class of debt instruments measured at amortised cost.
The amortised cost of a financial asset is the amount at which the financial asset is measured on initial recognition, less principal repayments, plus cumulative amortisation using the effective interest method on any difference between this initial amount and the amount at the end of the term, adjusted for impairment. The gross carrying amount of a financial asset correspondsto the amortised cost of a financial asset before adjustment for impairment.
The subsequent measurement of financial assets is performed using the effective interest method and is subject to the regulations for impairment in accordance with IFRS 9.5.5 etseq. At the Biotest Group, trade receivables, other financial assets, and bank balances are mainly subject to this category. The classification of financial assets at amortised cost is based on the business model in which
the financial assets are primarily held for the purpose of collecting contractual cash flows. These assets are subject to the expected credit loss (ECL) model in accordance with IFRS 9.
Financial assets measured at fair value through profit or loss:
This category includes financial assets that are not at least partially held to collect contractual cash flows (other business models). In particular, no intention exists to collect contractual cash flows if short‐term purchases and sales are planned. By definition, the category also includes derivatives that are not part of a hedging relationship as well as trade receivables designated for factoring. Financial assets that do not meet the cash flow criterion are always measured at fair value through profit or loss, irrespective of the underlying business model.
Financial assets in this category are measured at fair value at the end of each reporting period, with all gains and losses from fair value changes recognised in profit or loss unless they form part of a designated hedge.
The fair values recognised on the statement of financial position generally correspond to the market prices of the financial assets. If these are not immediately available, the fair values are calculated using recognised valuation models and by recourse to current market parameters. If the cash flows of a financial asset have already been contractually fixed, they are discounted at the market interest rates applicable on the valuation date. If the future cash flows are not fixed, they are first estimated on the basis of the current interest yield curve and forward rates and then discounted to the valuation date using the current discount factors. This method is used in particular for financial assets with fixed or variable cash flows. Classification and subsequent measurement are as described above. The calculation of fair value is described in section F 2.2.
Impairment of financial assets:
The Biotest Group recognises an allowance for expected losses on financial investments in debt instruments measured at amortised cost, trade receivables, and contract assets.
The amount of expected losses is updated on each reporting date in order to take account of changes in default risk since the re‐ spective financial instrument was initially recognised.
In general, the Biotest Group only recognises the expected loss over the remaining term if the default risk has increased significantly since initial recognition. If the default risk has not increased significantly since initial recognition, the Group continues to recognise the expected 12‐month loss as a value adjustment for these financial instruments.
The expected loss over the remaining term represents the loss deriving from all potential default events over the expected term of a financial instrument. In contrast, the 12‐month expected loss represents the portion of the loss expected over the term deriving from potential default events within the next twelve months after the reporting date.
The Biotest Group applies the simplified approach pursuant to IFRS 9.5.5.15 for trade receivables and contract assets. Under this approach, the allowance is always measured at the amount of the expected credit loss over the period. The expected losses are measured on an individual basis either on the part of the Biotest Group itself (assets with impaired creditworthiness) or based on an impairment matrix depending on the duration of the overdue period (assets without impaired creditworthiness). In the event of default patterns that diverge significantly from the impairment matrix based on overdue amounts, the percentages are adjusted taking region‐specific factors into consideration. This applies especially to customer groups with special credit risks, for example high‐risk countries, such as in the Middle East.
For cash and cash equivalents as well as other financial assets that are measured as debt instruments at amortised cost, the Biotest Group considers all reasonable and reliable information that is available without unreasonable cost and time expense in order to review a potentially significantly increase in an expected credit risk. This is primarily realised by relying on the associated credit risk. The expected losses are measured on an individual basis by an external service provider (assets without in‐creased credit risk).
Significant increase in default risk
To assess whether the default risk of a financial instrument has increased significantly since initial recognition, the Biotest Group compares the risk of default of the financial instrument as of the reporting date with the corresponding risk of default of the financial instrument at the time of initial recognition. In making this assessment, the Group considers both qualitative and quantitative infor‐ mation that is reasonable and supportable, including historical experience and forward‐looking information that is available without undue effort or cost.
When assessing whether default risk has increased significantly since initial recognition, the following information in particular is taken into consideration:
- an actual or expected significant deterioration in the external (if any) or internal rating of the financial instrument;
- significant deterioration in external market indicators for the default risk of a financial instrument, such as a significant increase in the credit spread, prices for credit default swaps for the debtor or the period, or the extent to which the fair value of a finan‐ cial asset lies below its acquisition costs;
- existing or forecast adverse changes in the business, financial, or economic situation that are likely to lead to a significant deterio‐ ration in the debtor's ability to fulfil its obligations;
- an actual or expected significant deterioration in the debtor's operating results;
- a significant increase in the default risk for other financial instruments of the same debtor;
- an actual or expected significant adverse change in the regulatory, economic, or technological environment of the debtor that leads to a significant reduction in the debtor's ability to fulfil its obligations.
Irrespective of the outcome of the assessment described above, the Biotest Group assumes that a financial asset's default risk has increased significantly since initial recognition if contractual payments are more than 30 days overdue, unless the Group has ade‐ quate and verifiable information that proves otherwise.
The Group regularly monitors the criteria applied in order to determine whether a significant increase in default risk has arisen, and, if necessary, reviews them to ensure that the criteria are suitable for recognising a significant increase in default risk before default occurs.
Definition of a default event
The Biotest Group considers the following circumstances to comprise events of default for the purposes of internal credit risk man‐ agement, as historical experience shows that financial assets that fulfil one of the following criteria are generally considered uncol‐ lectible:
- The breach of contractually agreed financial covenants by the debtor; or
- The existence of internally determined information or information obtained from external sources that indicates that the con‐ tractual payments cannot be made in full.
Notwithstanding the above analysis, in principle the Biotest Group assumes that a default has occurred if the contractual payments are more than 365 days overdue, unless the Group has adequate and verifiable information to prove that a financial asset is still recoverable.
However, for certain customer groups with different payment terms, a default is only assumed if the payments are more than three years overdue. This assessment is based on the experience that payments have continued to be received in the past despite being overdue for an extended period, and that the Group has appropriate and comprehensible information that proves the recoverability of the receivables. Nevertheless, such receivables are subject to extended monitoring in order to take appropriate account of risks, and to apply corresponding valuation allowances. In addition, receivables from these customer groups that have been written off in full are still subject to measures to enforce the receivables, including legal action and negotiations, as a consequence of which a possibility exists that future payments will be made. This ongoing monitoring and enforcement is taken into consideration in accord‐ ance with the requirements of IFRS 9.
Financial assets with objective evidence of impairment
Objective evidence of impairment exists if one or more events with a negative impact on the expected future cash flows of this financial asset have occurred (asset with impaired creditworthiness).
Proof that objective evidence of impairment exists includes the following events:
- Significant financial difficulties on the part of the issuer or the borrower;
- Breach of contractually agreed financial covenants, such as default or overdue payment;
- It becomes probable that the borrower will be forced into bankruptcy or other financial reorganisation; or
- The disappearance of an active market for this financial asset due to financial difficulties.
Derecognition of financial assets
A financial asset is derecognised if one of the following conditions is met:
- The contractual rights to receive cash flows from a financial asset have expired.
- The Group has transferred its contractual rights to receive cash flows from the financial asset from third parties or has assumed a contractual obligation to immediately pay the cash flow to a third party as part of a so‐called transfer agreement and has either (a) transferred substantially all opportunities and risks associated with ownership of the financial asset, or (b) neither transferred nor retained substantially all opportunities and risks associated with ownership of the financial asset, but has transferred control of the asset.
If the Group transfers its contractual rights to receive cash flows from an asset or enters into a transfer agreement, and neither transfers nor retains substantially all the risks and rewards of ownership of the asset but retains control of the transferred asset, the Group recognises an asset to the extent of the continuing involvement.
Financial liabilities:
Financial liabilities regularly substantiate a right of restitution in cash and cash equivalents or another financial asset. This includes, in particular, bonds and other securitised liabilities, trade payables, contractual liabilities, liabilities to banks, finance lease liabilities, promissory note loans, and liabilities from derivative financial instruments.
Financial liabilities are measured at fair value on initial recognition. Transaction costs that are directly attributable to the issue of financial liabilities that are not measured at fair value through profit or loss reduce the fair value of the financial liabilities on initial recognition. Transaction costs that are directly attributable to the issue of financial liabilities measured at fair value through profit or loss are recognised immediately through profit or loss.
Financial liabilities recognised at fair value through profit or loss
Financial liabilities are categorised as financial liabilities at fair value through profit or loss if they comprise an acquirer's contingent consideration as part of a business combination, are held for trading, or are voluntarily designated as at fair value through profit or loss.
A financial liability is categorised as held for trading if
- it was acquired primarily with the intention of being repurchased in the short term;
- on initial recognition, it is part of a portfolio of financial instruments that are clearly identified and jointly controlled by the Group, and for which there are indications of short‐term profit‐taking in the recent past; or
- it is a derivative that is not designated and effective as a hedging instrument and does not constitute a financial guarantee.
Financial liabilities designated as at fair value through profit or loss are recognised at fair value. All gains or losses deriving from the measurement are recognised in profit or loss unless they form part of a designated hedge. The net profit or loss recognised in profit or loss includes interest paid on the financial liability.
The calculation of fair value is described in section F 2.2.
Financial liabilities measured at amortised cost
Financial liabilities that do not represent contingent consideration from an acquirer in a business combination, are not held for trading, and are not designated as at fair value through profit or loss are measured at amortised cost applying the effective interest method.
The effective interest method is a method for calculating the amortised cost of a financial liability and the allocation of interest expenses to the respective periods. The effective interest rate is the rate that discounts estimated future cash payments – including all fees and charges paid or received that form an integral part of the effective interest rate, transaction costs, and other premiums or discounts – through the expected life of the financial instrument, or a shorter period, to the net carrying amount on initial recog‐ nition.
Trade payables are initially measured at nominal value, which corresponds to their fair value. As only current trade payables exist, the effective interest method is not applied in subsequent measurement. Financial liabilities from primary financial in‐struments are measured at amortised cost using the effective interest method. Financial liabilities from derivative financial instruments for which
hedge accounting is not applied are measured at fair value through profit or loss. Financial liabilities are classified as current unless the Group has the unconditional right to defer repayment of the liability until at least twelve months after the reporting date.
Financial liabilities are recognised at the loan amount less transaction costs and subsequently measured at amortised cost using the effective interest method. Any difference between the net loan amount and the redemption value is recognised in the income state‐ ment over the term of the financial liability.
Offsetting financial liabilities and assets
Financial assets and liabilities are only netted if a right of set‐off exists for the net amount at that time. As the Group does not fulfil this requirement, it does not net financial assets and liabilities.
Derecognition of financial liabilities:
Financial liabilities are derecognised when the contractual obligations are discharged, cancelled or expire. Financial liabilities are also derecognised when their contractual terms are modified and the cash flows of the modified liability are significantly different. In this case, a new financial liability is recognised at fair value based on the adjusted terms. When the financial liability is derecognised, the difference between the carrying amount of the extinguished liability and the consideration paid (including any non‐cash assetstrans‐ ferred or liabilities assumed) is recognised in profit or loss.
Derivative financial instruments:
The Biotest Group uses derivative financial instruments such as forward exchange contracts to hedge currency risks.
Derivative financial instruments are initially recognised at fair value at the time when the contract is concluded, and subse‐quently measured at fair value on each reporting date. Both the counterparty credit risk and the Group's own credit default risk are taken into consideration in the calculation.
The fair value is calculated on the basis of the market information available and valid on the reporting date. The Biotest Group does not utilise hedges. As a consequence, all derivatives are accounted for in accordance with the measurement category at fair value through profit or loss.
The gain or loss deriving from the measurement of derivatives is recognised in profit or loss unless the derivative is designated as a hedging instrument in a hedge, and is effective.
A derivative with a positive market value is recognised as a financial asset, while a derivative with a negative market value is recog‐ nised as a financial liability.
Embedded derivatives:
An embedded derivative is a component of a hybrid contract that also contains a non‐derivative host contract – with the conse‐ quence that some of the cash flows of the compound financial instrument are similar to those of a stand‐alone derivative.
Embedded derivatives whose host contract is a financial asset within the application scope of IFRS 9 are not separated. The hybrid contract is classified in its entirety and consequently measured either at amortised cost or at fair value, depending on the classifica‐ tion.
Derivatives embedded in non‐financial host contracts or host contracts in the form of a financial liability are treated as stand‐alone derivatives if they fulfil the requirements of a derivative, their economic characteristics and risks are not closely related to the host contract, and the entire contract is not measured at fair value through profit or loss.
If the hybrid contract represents a recognised financial liability, the Group designates the entire contract as at fair value through profit or loss rather than separating the embedded derivative.
An embedded derivative is recognised as a non‐current asset or non‐current liability if the remaining term of the corresponding host contract is longer than twelve months, and it is not expected to be realised or settled within twelve months.
B 13 REVENUE
The Biotest Group generates most of its revenue from supplying customers with biotechnological drugs from its own production. The product portfolio covers the therapeutic areas of haematology, clinical immunology, and intensive care medicine. As a rule, the sale of products is based on customer orders, each of which originates individually definable performance obligations. The relevant ancillary conditions are governed by master agreements or general terms and conditions of business. Revenue is recognised when control of the products is transferred to the customer. This is the point in time at which the benefits and encumbrances as well as the risk of accidental loss are transferred to the customer on the basis of the agreed Incoterms. An individual selling price agreed with the respective customer exists for each drug delivered. In some cases, Biotest grants discounts in the form of rebates and cash discounts in the form of a fixed percentage of the agreed individual sales price. Rebates and discounts are recorded as sales deduc‐ tions.
In addition, the Biotest Group – to a significantly lesser extent – generates revenue from the processing of blood plasma, which is provided by customers and processed into drugs by Biotest (so‐called toll manufacturing). The drugs manufactured are supplied exclusively to the customer that provided the plasma used for this purpose. Biotest is remunerated exclusively for the processing of the plasma remaining the property of the customer. As Biotest is not entitled to use the processed plasma for other purposes, revenue from toll manufacturing is recognised on a period basis. Furthermore, on the basis of the contractual agreements, Biotest is not the owner of the processed plasma. Pharmaceuticals manufactured as part of toll manufacturing are recognised as contract assets over the production period until delivery to the customer. Biotest uses an input‐based method to measure contract assets, by which the services rendered, including the related share of profit, are determined on the basis of the stage of completion and rec‐ ognised as revenue. To determine the stage of completion, all internal and external production costs incurred during the manufac‐ turing process are set in relation to the calculated total costs (cost‐to‐cost method). The method used provides an accurate picture of the transfer of the services provided by Biotest, as Biotest is likely to charge the capitalised amount in the event of early termina‐ tion of the contract by the customer.
To a minor extent, the Biotest Group generates revenue from the sale of purchased products that are resold to customers as mer‐ chandise. The same criteria apply to the recognition of sales of merchandise as for therapy products manufactured in‐house.
On 31 May 2023, Biotest signed a technology transfer and licensing agreement with Grifols, S.A., Barcelona, Spain, with effect from 1 January 2023. The technology transfer and licensing agreement ensures that Biotest's new product developments (Yimmugo®, Fibrinogen, and Trimodulin) can be manufactured and marketed worldwide by making recourse to Grifols' organisation and produc‐ tion network. According to the agreement, Biotest is to disclose a total of six technology components and provide development services for certain products. A standard market transaction price was determined for the services agreed in the contract with the help of a valuation report using capital‐value‐oriented methods, which consists of both fixed and variable payments. Biotest receives fixed one‐off payments for the disclosure of the technology and for the provision of development results as well as the further implementation of developmentservices. A licensing agreement was also concluded, which entails a revenue‐based licence payment to Biotest following successful approval of the new products. Revenue from non‐refundable one‐off payments for the disclosure of technologies is recognised at a specific point in time after the transfer of information to the customer. In the case of revenue from development services, where the customer receives the benefit continuously, revenue is recognised over a period of time. An input‐ based (cost‐to‐cost, as‐invoiced) method is applied, whereby internal and external costs that have been incurred as of the given date are charged to the customer with a markup. The method used appropriately reflects the pattern of transfer of the services provided by Biotest and thus ensures a true reflection of the service provision.
The Biotest Group usually concludes master agreements with its customers in which pharmaceutical quality and safety standards are regulated in addition to delivery and payment terms and liability for defects. In the case of some customers, these terms and conditions are governed solely by the Biotest Group's general terms and conditions of business. The master agreements do not create any binding delivery and service obligations; these are only triggered by specific orders from customers.
The Biotest Group has agreed variable payments with some customers in the form of annual reimbursements, for which the per‐ centage applied for the reimbursement varies depending on the sales volumes achieved over the year. For such variable payments, the Biotest Group makes estimates in order to determine the expected amount of the reimbursement. These esti‐mates are not subject to significant risks of change. Obligations from annual reimbursements together with credits and rebates yet to be invoiced are recognised as other financial liabilities.
The master agreements concluded with customers and the general terms and conditions of business provide forthe usual guarantees and warranty obligations that arise when the products delivered to the customer are defective. In such a case, Biotest takes the products back and offers the customer either a subsequent delivery or a refund of the purchase price. The guarantees granted by Biotest do not give rise to any independent performance obligations in the meaning of IFRS 15. Obligations from guarantees and warranty obligations are measured in accordance with IAS 37 and recognised under other provisions as provisions for master con‐ tracts (E 14).
Estimates regarding revenue, costs or order progress are corrected if circumstances change. Any resultant increases or decreases in estimated revenue or costs are recognised in profit or lossin the period in which the circumstances giving rise to the correction come to the attention of management.
B 14 RESEARCH AND DEVELOPMENT COSTS
Research and development costs are expensed when incurred. Development costs that meet the requirements for capitalisation under IAS 38 are capitalised.
B 15 GOVERNMENT GRANTS
Government grants are recognised when reasonable assurance exists that the grants will actually be received, and that the Group will comply with the conditions attached to them.
Government grants are recognised in the income statement on a systematic basis over the periods in which the Group recognises the corresponding expenses that are intended to compensate for the government grants as expenses.
Grantsfor an asset are recognised as a deduction from the carrying amount of the asset on which the grant is based, with a reduction in depreciation expense in subsequent periods.
Government grantsthat are paid as compensation for expenses orlosses already incurred, orforimmediate financialsupport without future related expenses, are recognised in profit or loss in the period in which the corresponding entitlement exists, and deducted from research and development costs.
B 16 FINANCIAL INCOME AND FINANCIAL EXPENSES
Interest is recognised as expense or income at the time it arises. Interest expenses comprise two components. On the one hand, interest expenses arise from the accumulation of interest on non‐current discounted liabilities, especially lease liabilities in accord‐ ance with IFRS 16. The interest portion included in the lease payments for leases is calculated using the method described in IFRS 16.37, and recognised as interest expense. This method applies a discount rate that discounts estimated future cash flows over the term of the lease to the net carrying amount of the obligation. Furthermore, interest expenses also include actual interest payments on financial liabilities. Interest income includes income from invested cash and cash equivalents, interest‐bearing receivables, and other financial instruments. In addition, the financial result includes all income and expenses from currency translation and value adjustments on financial instruments measured at fair value. Interest from loans granted to third parties, which are reported under other financial assets, is recognised in the financial result. The financial result also includes interest from financial liabilities.
Expenses and income from currency hedging and interest hedging costs are shown in financial income and financial expenses.
B 17 TAXES
Actual tax assets and tax liabilities for the current period and for earlier periods are to be measured at the amount of the ex‐pected refund from or payment to the tax authorities. The amount is calculated based on tax rates and tax legislation reflecting the respec‐ tive national tax regulations of the countries in which Biotest Group companies operate.
Deferred tax assets are recognised for all deductible temporary differences, as yet unutilised tax loss carryforwards, and unu‐tilised tax credits to the extent that it is probable that taxable income will be available against which the deductible temporary differences, as yet unutilised tax loss carryforwards, and tax credits can be offset.
The carrying amount of deferred tax assets is reviewed on each reporting date and reduced by the amount by which it is no longer probable that sufficient taxable income will be available to at least partially offset the deferred tax asset. In addition, unrecognised deferred tax assets are reviewed on each reporting date and recognised at the amount at which it has become probable that future taxable income will allow the deferred tax asset to be realised.
Current tax rates or rates already approved by parliament are used to determine both current tax expense and deferred taxes.
Deferred tax assets and deferred tax liabilities are offset against each other if enforceable claims exist to offset actual tax refund claims against actual tax liabilities and these claims apply to income taxes of the same tax subject levied by the same tax authority.
The Biotest subgroup, which is part of the Grifols Group (Grifols, S.A.), falls within the scope of the regulations on global minimum taxation ("Pillar 2"). The regulations on global minimum taxation came into force in Germany in the form of the Minimum Taxation Act (Mindeststeuergesetz, "MinStG") with effect from 28 December 2023. The MinStG applies for the first time to financial years beginning after 30 December 2023. According to the MinStG, a supplementary tax is payable for each jurisdiction that has an effective tax rate below 15 %. The Grifols Group is based in Spain, where identical legislation applies. Biotest AG is a so‐called partially owned parent company that isliable for any additional tax due for its low‐taxed subsidiaries. The company may also be liable for a minimum tax under the national additional tax.
On the basis of the CbCR safe harbour rules (Section 84 MinStG), the Grifols Group is not expected to incur a tax liability under the Minimum Taxation Act in 2024.
B 18 UNCERTAIN ESTIMATES AND DISCRETIONARY JUDGEMENTS
The preparation of the financial statements requires judgments and estimates that affect the application of accounting policies and the reported amounts of assets and liabilities, income, expenses, contingent assets and contingent liabilities. Actual results may differ from these estimates.
All estimates and judgments are continuously reviewed and are based on past experience and other factors, including expectations of future events that may have a financial impact on the company and are considered reasonable under the given circumstances. Changes are recognised prospectively in the reporting period or in future periods.
Assumptions and estimation uncertainty
Information about assumptions and estimation uncertainties at the reporting date that pose a significantrisk ofresulting in a material adjustment to the carrying amounts of assets and liabilities within the next financial year is included in the following notes:
- Recognition and measurement of provisions as well as contingent assets and liabilities: significant assumptions regarding the probability and extent of inflows and outflows of benefits – notes D 13, D 14 and E 6
- Impairment loss estimation based on expected credit losses for trade receivables and contract assets: key assumptions in deter‐ mining the weighted average default rates – note E 3
- Impairment testing of intangible assets and goodwill: significant assumptions used in determining the recoverable amount, in‐ cluding the recoverability of development costs – note D 1
- Estimation of useful lives of intangible assets and property, plant and equipment notes D 1 and D 2
- Estimation of the fair value of certain financial assets note E 2
- Recognition of deferred tax assets: availability of future taxable income against which deductible temporary differences and tax loss carryforwards can be utilised – notes C 10 and D 6
- Estimation uncertainties and judgements related to the accounting of lease agreements note D 3
- Estimation of the obligation for defined benefit pension plans: key actuarial assumptions note E 13
- Allocation of raw material costs to finished products in the cost of production note D 7
- Application of IAS 29 for hyperinflationary economies note B 3
Regarding revenue from the technologies disclosed to Grifols, S.A., further significant estimates are made (see notes B 13 and C 1):
- Estimates of future sales prices for new products manufactures based on the disclosed technologies;
- Allocation of raw material costs;
- Yields in the production process;
- Required capital expenditures and probability of success of product development
The allowancesfor receivablesin countriessubject to sanctions by the European Union are estimated on the basis of expected future payment defaults and are consequently also subject to estimation uncertainties.
Judgements
In addition to estimates, certain judgments by management are required, particularly regarding the application of accounting policies under IFRS. These judgements are based on past experience, assessments from experts (e.g. lawyers, rating agencies, industry asso‐ ciations), and the careful consideration of various scenarios. Significant judgments relate to the following matters:
- Lease term: Determination of whether the exercise of extension options is reasonably certain note B 6
- Revenue recognition: Determination of the timing of revenue recognition and the allocation of the transaction price to perfor‐ mance obligations – note C 1
All estimates and judgments are continuously reviewed and are based on past experience and other factors, including expectations of future events that may have a financial impact on the company and are considered reasonable under the given circumstances.
The key assumptions and parameters underlying the estimates and judgements made are explained for each topic in the notes to the financial statements.
B 19 CONTINGENT ASSETS AND CONTINGENT LIABILITIES
A contingent asset is a potential asset that derives from past events and whose existence will not be confirmed until the occurrence or non‐occurrence of one or more uncertain future events that do not lie entirely within the company's scope of control. Contingent liabilities are potential obligations that originate from past events and whose existence will not be confirmed until the occurrence or non‐occurrence of one or more uncertain future events that do not lie entirely within the company's scope of control. Contingent liabilities may also be based on current obligations that derive from past events but are not recognised in the financial statements, either because an outflow of resources with a loss of economic benefits is not likely or because the amount of the obligation cannot be estimated sufficiently reliably.
B 20 GENERAL VALUATION OF DEFERRED TAXES
The Group applied the temporary mandatory exemption from recognising deferred taxes arising from the introduction of global minimum taxation and will recognise these taxes as actual tax expense/income when they arise.
C. SEGMENT REPORTING
The information disclosed in the segment report has been prepared in accordance with IFRS 8 and the "Managmeent Approach".
The review of the Biotest Group's reporting and management structure has led to an amendment in the segment reporting in ac‐ cordance with the provisions of IFRS 8. Consequently, Biotest is of the opinion that the segments European Union, Rest of the World and Stateless, as reported in the previous financial year 2023, do not meet the criteria for operating segments under IFRS 8. This requires an error correction in accordance with IAS 8 et seq. The segment reporting for the previous year was adjusted accordingly.
The Biotest Group operates within a uniform business segment characterized by a joint production process. All production takes place at the Group's headquarters in Dreieich, Germany. Within this structure, there is only one supreme decision‐making authority, the so‐called "Chief Operating Decision Maker" (CODM), who is responsible for the strategic management of the Biotest Group as a whole. The CODM is the Management Board. All key decisions, including the allocation of resources, are made by the CODM on the basis of consolidated reportsthat reflect the entire operating unit. Accordingly, due to the special features of the production process, the Executive Board only uses a consolidated income statement and a consolidated balance sheet for the company as a whole. This procedure illustrates the homogeneous structure of the Biotest Group and the focus on an integrated business strategy.
In the consolidated financial statements for the 2023 financial year, only sales were broken down into the sales regions of the Euro‐ pean Union, Rest of the World and Stateless. The following table splits sales by domestic (Germany) and rest of the world.foreign (Rest of the World). Sales revenue > 10% was generated with the customer Grifols, S.A., amounting to € 123.1 million (previous year: € 190.1 million). Sales revenues that are allocated to a single foreign country and that reach a significant level amount to € 141.3 million (previous year: € 194.8 million) with a customer in Spain. Sales by Rest of the World are allocated according to the customer's registered office.
| Revenue with third parties based on customer's seat |
Revenue with third parties based on company's seat |
||||
|---|---|---|---|---|---|
| in € million | 2024 | 2023 | 2024 | 2023 | |
| Biotest Group | 726.2 | 684.6 | 726.2 | 684.6 | |
| thereof: | |||||
| Germany | 160.8 | 140.5 | 684.8 | 616.2 | |
| Rest of the world | 565.4 | 544.1 | 41.4 | 68.4 |
D. EXPLANATORY NOTES TO THE STATEMENT OF INCOME
D 1 REVENUE
ANALYSIS OF REVENUES FROM CONTRACTS WITH CUSTOMERS
To illustrate the impact of economic factors on the nature, amount, timing, and uncertainty of revenues and the cash flows they generate, Biotest Group revenues can be classified into the following categories:
| Categories | Total | |
|---|---|---|
| in € million | 2024 | 2023 |
| Type of products and services | ||
| Sale of Biotest products | 563.4 | 451.3 |
| Toll manufacturing | 39.7 | 43.2 |
| Technology disclosure and development services | 123.1 | 190.1 |
| 726.2 | 684.6 | |
| Timing of revenue recognition | ||
| Goods transferred at a point in time | 647.6 | 604.8 |
| Services transferred over a period of time | 78.6 | 79.8 |
| 726.2 | 684.6 |
Revenue from technology disclosure and development services amounted to € 123.1 million (previous year: € 190.1 million). This is due to the fact that four out of six technologies were already disclosed in the previous year.
The Biotest Group's order book position from as yet unfulfilled delivery and service obligations amounted to € 68.2 million as of the reporting date (previous year: € 110.2 million). These delivery and service obligations are generally rendered within a maximum period of one year.
D 2 COST OF MATERIALS
| in € million | 2024 | 2023 |
|---|---|---|
| Raw materials, consumables and supplies | 249.5 | 174.2 |
| Services purchased | 48.7 | 45.5 |
| 298.2 | 219.7 |
D 3 PERSONNEL EXPENSES
| in € million | 2024 | 2023 |
|---|---|---|
| Wages and salaries | 177.2 | 161.7 |
| Social security contributions | 32.4 | 29.8 |
| Pension costs | 5.0 | 5.7 |
| 214.6 | 197.2 |
Personnel expenses include expenses for severance payments of € 2.9 million (previous year: € 2.4 million).
The average number of employees converted to full‐time equivalents in the 2024 financial year was 2,476 (previous year: 2,365). As of 31 December 2024, the Biotest Group employed 2,495 staff, when calculated on the basis of full‐time equivalents (previous year: 2,426).
Employees are allocated to the following functional areas:
| in full‐time equivalents | 31.12.2024 | 31.12.2023 |
|---|---|---|
| Production | 1,915 | 1,828 |
| Administration | 218 | 223 |
| Distribution | 143 | 143 |
| Research and development | 219 | 232 |
| 2,495 | 2,426 |
D 4 RESEARCH AND DEVELOPMENT COSTS
Research and development expenses recognised in the income statement amounted to € 56.8 million (previous year: € 66.8 million).
As part of the technology transfer and licensing agreement with Grifols, S.A., Biotest conducts research and development activities for the development of the new products, and the development results are utilised jointly by Biotest and Grifols. Grifols reimburses the development costs with a profit mark‐up, which is recognised within revenue. In the 2024 financial year, development costs of € 38.9 million (previous year: € 36.6 million) were recognised in research and development costs as part of the technology transfer and licensing agreement.
In the 2024 financial year, research allowances in accordance with the Research Allowance Act (FZulG) amounting to € 0.2 million were recognised (previous year: € 0.1 million). The German Federal Ministry of Education and Research (BMBF) grant expired in the 2023 financial year, and as a consequence was not recognised in the 2024 financial year (previous year: € 8.0 million). Please see our remarks in section A.IV. Research and development (general) in the summarised management report.
In the 2024 financial year, development costs of € 3.0 million (previous year: € 0.0 million) were capitalised as internally gener‐ated intangible assets.
| 2024 | 2023 |
|---|---|
| 0.9 | 0.2 |
| – | 23.1 |
| 0.1 | 0.1 |
| 0.1 | 0.4 |
| 3.8 | 0.1 |
| 0.1 | 0.8 |
| 3.4 | 2.2 |
| 8.4 | 26.9 |
D 5 OTHER OPERATING INCOME
This development results, on the one hand, from the recognition of the gain on disposal in the amount of € 23.1 million from the divestiture of five Biotest subsidiaries in the prior‐year period. Another effect in the 2024 financial year results primarily from the reversal of a financial liability in connection with plasma supply contracts in the amount of € 3.8 million.
In the 2024 financial year, impairment losses and gains on financial assets and contract assets are presented in a separate item, "Impairment losses and gains(including reversals of impairment losses) on financial assets and contract assets", for both the financial year and the comparative period.
In the previous year 2023, additions to value adjustments of € 6.2 million and reversals of value adjustments of € ‐6.1 million were reported netted at € 0.1 million under other operating income. The reclassification comprises a net amount of € 0.1 million. The reported other operating income of € 27 million in the previous year is now shown at € 26.9 million in the comparative period.
In the financial year, there was also a retrospective adjustment of the impairments on trade receivables reported in the previous year in the amount of € 0.9 million due to an adjustment in the notesto the consolidated financialstatements. Please refer to section E 8 Trade receivables.
D 6 OTHER OPERATING EXPENSES
| in € million | 2024 | 2023 |
|---|---|---|
| Expenses incurred in connection with provision of services | 0.1 | 2.7 |
| Donations | 0.1 | 0.3 |
| Prior‐period expenses | – | 9.2 |
| Other | 0.3 | 3.8 |
| 0.5 | 16.0 |
In the previous year, expenses from additions to the provision in connection with price moratoriums in the amount of € 9.2 million were recognised in prior‐period expenses.
D 7 FINANCIAL INCOME
| in € million | 2024 | 2023 |
|---|---|---|
| Income from currency translation | 6.2 | 5.3 |
| Interest income from loans receivable | 2.0 | 2.0 |
| Subtotal | 8.2 | 7.3 |
| Currency hedging income | 1.7 | 2.4 |
| Subtotal of income from fair value adjustments on financial instruments measured at fair value | 1.7 | 2.4 |
| 9.9 | 9.7 |
Income from currency translation includes income from realised foreign exchange gains in connection with foreign currency receiv‐ ables and payables, and income from unrealised price gains from the measurement as of the reporting date of foreign currency positions.
The income from currency hedging includes income from the measurement of currency hedging transactions at fair value.
D 8 FINANCIAL EXPENSES
| in € million | 2024 | 2023 |
|---|---|---|
| Currency translation expenses | 4.8 | 5.9 |
| Interest expenses from loan liabilities | 27.6 | 34.5 |
| Interest expenses from leases | 2.7 | 2.1 |
| Net interest expenses for pensions | 3.0 | 3.4 |
| Fees in connection with financial liabilities | 1.4 | 0.2 |
| Other | 0.1 | – |
| Subtotal | 39.6 | 46.1 |
| Expenses from value adjustments of surrender claim against trustee from shares in ADMA Biologics Inc. | – | 0.9 |
| Currency hedging costs | 4.2 | 2.6 |
| Subtotal of expenses from fair value adjustments on financial instruments measured at fair value | 4.2 | 3.5 |
| 43.8 | 49.6 |
Expenses from currency translation include expenses from realised foreign exchange losses in connection with foreign currency re‐ ceivables and payables, as well as expenses from unrealised price losses from the measurement as of the reporting date of foreign currency positions.
Interest expenses include interest of € 7.1 million for shareholder loans (previous year: € 7.6 million).
The decrease in financial expenses is mainly due to the € 6.9 million reduction in interest expenses in connection with the partial repayment of an existing external financing.
The reported expenses from currency hedging include expenses from the fair value measurement of currency hedging transactions.
D 9 RESULT FROM JOINT VENTURES
In the 2024 financial year, a loss of € ‐4.4 million (prior year: profit of € 2.8 million) was recognized as regular share of results from the joint venture BioDarou P.J.S. Co., based in Tehran, Iran. Additionally, in the 2024 financial year, an impairment of € 9.7 million was applied to the investment in BioDarou, which was fully recognized under the result from joint ventures. This impairment was determined as part of an impairment test (please refer to Note E 4 "Interests in Joint Ventures"). The carrying amount of this invest‐ ment after the impairment is € 2.1 million (prior year: € 11.3 million). As a result, a loss from joint ventures of € ‐14.1 million (prior year: profit of € 2.8 million) wasrecognized in the 2024 financial year. With regard to the effects of the application of IAS 29 Financial Reporting in Hyperinflationary Economies, please refer to the explanations in Note E 4.
D 10 INCOME TAXES
| in € million | 2024 | 2023 |
|---|---|---|
| Tax expense for the financial year | 7.1 | 12.6 |
| Tax income from other periods | – – |
|
| Current taxes | 7.1 | 12.6 |
| Deferred taxes | 13.1 | –33.3 |
| Income tax expenses (previous year: income tax incomes) | 20.2 | –20.7 |
Deferred taxes from items relating to amounts in other comprehensive income (credited directly to equity) amounted to € ‐ 0.2 million (previous year: € ‐ 0.8 million).
For the 2024 financial year, the expected tax expense assuming an unchanged nominal income tax rate of 29.0 % differs from the effective figures as follows:
| in € million | 2024 | 2023 |
|---|---|---|
| Earnings before taxes | 46.5 | 106.3 |
| – | ||
| Expected tax expense | 13.5 | 30.8 |
| Unrecognised interest/tax loss carryforwards | 0.1 | 0.2 |
| Tax effects from the application of foreign tax rates | 2.6 | 0.3 |
| Deferred taxes on loss carryforwards from previous years | – | –27.1 |
| Tax effect of adjustments to deferred taxes from previous years (utilisation of loss carryforwards) | –0.1 | –21.9 |
| Tax effect of non‐deductible expenses | 4.1 | 6.4 |
| Tax effect of tax‐free income | –0.4 | –9.4 |
| Other effects | 0.4 | – |
| Income tax expense (previous year: income tax income) disclosed in the statement of income | 20.2 | –20.7 |
Due to the positive result in 2023, the tax loss carryforwards and the interest expenses of Biotest AG that can be carried forward were partially utilised (€ 21.9 million). Deferred taxes were capitalised on the remaining portions (€ 27.1 million).
The tax effects from non‐deductible expenses are largely attributable to Biotest AG (€ 3.8 million, previous year: € 5.2 million).
The tax‐exempt income originates mainly from Biotest AG and includes dividends from subsidiaries included in the consolidated financial statements (€ 0.3 million, previous year: € 1.0 million) and the allocation of income from controlled companies (€ 1.4 mil‐ lion, previous year: € 0).
The calculated tax rate of 29.0 % is based on a corporate tax rate of 15.0 %, a solidarity surcharge of 5.5 % and the weighted trade tax rates of the municipalities of the business premises of Biotest AG of 13.2 %.
D 11 AUDITOR'S FEE
The Annual General Meeting of Biotest AG on 7 May 2024 elected Deloitte GmbH Wirtschaftsprüfungsgesellschaft as auditor for the 2024 financial year.
The total fee invoiced by the auditor Deloitte GmbH Wirtschaftsprüfungsgesellschaft in the 2024 financial year amounts to € 0.7 mil‐ lion. Of this amount, € 0.5 million relates to auditing services and € 0.2 million to other certification services.
The auditservices mainly comprise the fee for the statutory audits of the separate financialstatements and the consolidated financial statements, the disclosure report, the audit of the risk early warning system, and the audit of the dependent company report.
The other certification services mainly comprise the fee for the voluntary audit of Biotest AG's sustainability report and the EMIR certificate and the compensation report.
This audit for the 2024 financial year is the first audit of the company conducted by Deloitte GmbH Wirtschaftsprüfungsgesellschaft. As a consequence, for the 2023 financial year, no auditor'sfeesrelate to Deloitte GmbH Wirtschaftsprüfungsgesellschaft. In the 2023 financial year, the total fee for the auditor KPMG AG Wirtschaftsprüfungsgesellschaft amounted to € 0.8 million. Of this, € 0.7 million was for audit services and € 0.1 million for other certification services.
E. EXPLANATORY NOTES TO THE STATEMENT OF FINANCIAL POSITION
E 1 INTANGIBLE ASSETS
Intangible assets are allocated to non‐current assets.
| in € million | Goodwill | Capitalized development costs |
Patents, licenses, software and similar rights |
Advance payments made and development projects in progress |
Total |
|---|---|---|---|---|---|
| Cost of purchase | |||||
| Balance as of 31 December 2022 | 7.8 | 0.5 | 30.0 | 6.3 | 44.6 |
| Additions | – | – | 0.6 | 0.3 | 0.9 |
| Reclassifications | – | 0.6 | 0.1 | –0.7 | – |
| Disposals | –1.2 | – | – | – | –1.2 |
| Disposals from the scope of consolidation | –0.6 | – | –0.7 | –1.3 | |
| Currency translation differences | – | – | – | – | – |
| Balance as of 31 December 2023 | 6.0 | 1.1 | 30.0 | 5.9 | 43.0 |
| Additions | – | 3.0 | 0.1 | 0.5 | 3.6 |
| Reclassifications | – | – | 0.1 | –1.5 | –1.4 |
| Disposals | – | – | – | – | – |
| Disposals from the scope of consolidation | – | – | – | – | – |
| Currency translation differences | – | – | – | – | – |
| Balance as of 31 December 2024 | 6.0 | 4.1 | 30.2 | 4.9 | 45.2 |
| Accumulated depreciation | |||||
| Balance as of 31 December 2022 | 0.6 | – | 27.6 | – | 28.2 |
| Depreciation's for the financial year | – | 0.1 | 1.0 | – | 1.1 |
| Reclassifications | – | – | – | – | – |
| Disposals | – | – | – | – | – |
| Disposals from the scope of consolidation | –0.6 | – | –0.7 | – | –1.3 |
| Currency translation differences | – | – | – | – | – |
| Balance as of 31 December 2023 | – | 0.1 | 27.9 | – | 28.0 |
| Depreciation for the financial year | – | 0.1 | 0.6 | – | 0.7 |
| Reclassifications | – | – | – | – | – |
| Disposals | – | – | – | – | – |
| Disposals from the scope of consolidation | – | – | – | – | – |
| Currency translation differences | – | – | – | – | – |
| Balance as of 31 December 2024 | – | 0.2 | 28.5 | – | 28.7 |
| Carrying amount as of | |||||
| 31 December 2023 | 6.0 | 1.0 | 2.1 | 5.9 | 15.0 |
| 31 December 2024 | 6.0 | 3.9 | 1.7 | 4.9 | 16.5 |
Development costs of € 2.7 million were capitalised for the Fibrinogen project in the 2024 financial year (previous year: € 2.7 million). The carrying amount of the marketing authorisations already in use (for the Yimmugo® project) is € 3.9 million (previous year: € 1.0 million). As of 31 December 2024, the carrying amount of capitalised and current development costs totals € 6.6 million (pre‐ vious year: € 3.7 million).
Under the technology transfer and licensing agreement, Biotest undertakes to conduct or complete development work specified in the agreement (including for Yimmugo® and Fibrinogen). Grifolsfulfilsits obligations by assuming the costsfor developmentservices, in which Grifols also participates and which Biotest performs with a markup, whereby Biotest remains the owner of the know‐how and both parties benefit from the development results.
A goodwill impairment test was performed as of 31 December 2024.
In the previous year, goodwill was erroneously allocated to the operating segments. This allocation did not meet the requirements of IAS 36, as the goodwill did not have to be allocated to any individual cash‐generating unit (CGU).
In the financial year 2024, this error was corrected and goodwill is now considered as a single CGU at Group level in accordance with IFRS requirements. Since management and cash flow planning are carried out at the overall company level, the impairment test is now carried out at this level only, in accordance with the requirements of IAS 36.
A pre‐tax discount rate of 9.81 % (previous year: 9.91 %), which is based on the relevant WACC (weighted average cost of capital), was used for the goodwill impairment test. The expected cash flows were determined on the basis of the nine‐year financial plan prepared by the Board of Management. For the value component from 2034 onwards, this is supplemented by perpetual growth rates. The 2033 year formsthe basisfor determining the perpetual growth rate. The growth rate applied after the end of the detailed planning period is 1.5 % (previous year: 1.5 %).
The results of the impairment test are largely dependent on the strategic corporate planning and the assumed growth rates for revenue and the EBIT margin. An average revenue growth rate of 8.6 % (previous year: 12.8 %) p. a. was assumed for the detailed planning period. An average EBIT margin of 18.8 % (previous year: 18.1 %) is imputed. The assumptions used in the impairment test are based on both historical experience and external market data. Differences to past developments were analyzed and taken into account accordingly in the planning.
A detailed planning period of nine years was used for the impairment test. The longer planning period was chosen because the Biotest Group's business model is characterised by long‐term investment cycles and strategic market positioning. The corporate management is based on a multi‐year planning period that extends beyond the usual five years and reflects economic developments more realistically. The assumptions and forecasts on which the nine‐year planning horizon is based were regularly reviewed and found to be reliable.
A sensitivity analysis of the impairment test for goodwill shows that even with a realistic change in the key assumptions (an increase in the discount rate of 1 percentage point or a reduction in the EBIT margin of 1 percentage point), the recoverable amount continues to be above the carrying amount. Therefore, there is no need to disclose a detailed sensitivity analysis in accordance with IAS 36.134 (f).
An impairment test was carried out as of 31 December 2024 for capitalised, ongoing development projects that are not yet available for use (Fibrinogen project). The recoverable amount was determined in accordance with IAS 36 as the value in use. The calculation was based on the discounted cash flow method (DCF method). The DCF method was carried out with a detailed planning period of 20 years(2025‐2044). A detailed planning period of 20 yearsis assumed because the amortisation period for capitalised development projects is 20 years. The valuation is based on the discounted future cash flows of the current market conditions.
Key assumptions and valuation methods:
- Detailed planning period: 20 years (2025‐2044)
- Discount rate before tax (WACC): 13.18 % (previous year: 12.91 %)
A sensitivity analysis of the impairment test for capitalised, ongoing development projects shows that even with a realistic change in the key assumptions(an increase in the discount rate of 1 percentage point or a reduction in the approval probability of 1 percentage point), the recoverable amount continues to be above the carrying amount. Therefore, there is no need to disclose a detailed sensi‐ tivity analysis in accordance with IAS 36.134 (f).
For the carrying amounts of the intangible assets – goodwill in the amount of € 6.0 million (previous year: € 6.0 million) and capital‐ ised development costs in the amount of € 2.7 million (previous year: € 2.7 million) – which were subject to an impairment test, no need for impairment was identified.
Amortisation of intangible assets in the financial year is included in the following items of the consolidated income statement:
| in € million | 2024 | 2023 |
|---|---|---|
| Cost of sales | 0.2 | 0.6 |
| Administrative expenses | 0.3 | 0.4 |
| Research and development costs | 0.2 | 0.1 |
| 0.7 | 1.1 |
E 2 PROPERTY, PLANT AND EQUIPMENT
All assets listed below are allocated to non‐current assets
| in € million | Land and buildings |
Technical equipment and machinery |
Other facilities, office furniture and equipment |
Advance pay‐ ments made and assets under construction |
Total |
|---|---|---|---|---|---|
| Acquisition / production costs | |||||
| Balance as of 31 December 2022 | 318.0 | 335.6 | 114.7 | 87.5 | 855.8 |
| Additions | 5.9 | 3.2 | 8.2 | 15.2 | 32.5 |
| Reclassifications | –0.8 | 0.5 | –0.2 | 0.5 | – |
| Disposals | –0.4 | –0.2 | –0.3 | –0.5 | –1.4 |
| Disposals from the scope of consolidation | –0.3 | –0.2 | –0.3 | – | –0.8 |
| Currency translation differences | 0.2 | 0.2 | 0.1 | – | 0.5 |
| Balance as of 31 December 2023 | 322.6 | 339.1 | 122.2 | 102.7 | 886.6 |
| Additions | 0.3 | 3.3 | 2.5 | 18.7 | 24.8 |
| Reclassifications | 1.8 | 33.4 | 2.1 | –35.9 | 1.4 |
| Disposals | – | –0.3 | –1.2 | – | –1.5 |
| Disposals from the scope of consolidation | – | – | – | – | – |
| Currency translation differences | –0.7 | –0.5 | –0.1 | – | –1.3 |
| Balance as of 31 December 2024 | 324.0 | 375.0 | 125.5 | 85.5 | 910.0 |
| Accumulated depreciation | |||||
| Balance as of 31 December 2022 | 111.4 | 140.4 | 83.7 | – | 335.5 |
| Depreciation for the financial year | 10.4 | 12.8 | 6.2 | – | 29.4 |
| Disposals | – | –0.2 | –0.2 | – | –0.4 |
| Disposals from the scope of consolidation | –0.2 | –0.2 | –0.3 | – | –0.7 |
| Currency translation differences | 0.2 | 0.2 | – | – | 0.4 |
| Balance as of 31 December 2023 | 121.8 | 153.0 | 89.4 | – | 364.2 |
| Depreciation for the financial year | 10.4 | 13.1 | 6.2 | 3.6 | 33.3 |
| Reclassifications | – | – | – | – | – |
| Disposals | – | – | –1.1 | – | –1.1 |
| Disposals from the scope of consolidation | – | – | – | – | – |
| Currency translation differences | –0.5 | –0.7 | –0.1 | – | –1.3 |
| Balance as of 31 December 2024 | 131.7 | 165.4 | 94.4 | 3.6 | 395.1 |
| Carrying amount as of | |||||
| 31 December 2023 | 200.8 | 186.1 | 32.8 | 102.7 | 522.4 |
| 31 December 2024 | 192.3 | 209.6 | 31.1 | 81.9 | 514.9 |
Advance payments in the 2024 financial year mainly include capital expenditure incurred as part of the expansion of capacity at the Dreieich site. The assets under construction amount to € 19.0 million (previous year: € 25.2 million).
Additions to property, plant and equipment include borrowing costs of € 1.9 million (previous year: € 1.8 million). The financing cost rate used for borrowing costs is at 2.5 % (previous year: 2.5 %).
As of 31 December 2024, the Biotest Group had obligations to purchase non‐current assets amounting to € 6.7 million (previous year: € 7.3 million).
Depreciation of property, plant and equipment for the financial year is included in the following income statement items:
| in € million | 2024 | 2023 |
|---|---|---|
| Cost of sales | 27.1 | 23.9 |
| Marketing and sales costs | 0.3 | 0.3 |
| Administrative expenses | 5.3 | 4.7 |
| Research and development costs | 0.5 | 0.5 |
| 33.3 | 29.4 |
E 3 LEASES
The following table shows the carrying amounts of the right‐of‐use assetsrecognised on the statement of financial position and their changes during the financial year. All rights‐of‐use assets listed below are allocated to non‐current assets.
| in € million | Rights of use for buildings |
Rights of use for motor vehicles |
Rights of use of other equipment, furniture and fixtures |
Total |
|---|---|---|---|---|
| Acquisition / production costs | ||||
| Balance as of 1 January 2023 | 41.5 | 2.7 | 0.6 | 44.8 |
| Additions | 35.2 | 0.8 | 0.1 | 36.1 |
| Disposals | –2.8 | –0.5 | – | –3.3 |
| Disposals from the scope of consolidation | –1.3 | –0.7 | – | –2.0 |
| Currency translation differences | 0.2 | – | – | 0.2 |
| Balance as of 31 December 2023 | 72.8 | 2.3 | 0.7 | 75.8 |
| Additions | 6.8 | 0.8 | – | 7.6 |
| Disposals | –0.9 | –0.4 | –0.3 | –1.6 |
| Disposals from the scope of consolidation | – | – | – | – |
| Currency translation differences | –1.0 | – | – | –1.0 |
| Balance as of 31 December 2024 | 77.7 | 2.7 | 0.4 | 80.8 |
| Accumulated depreciation | ||||
| Balance as of 1 January 2023 | 15.5 | 1.5 | 0.3 | 17.3 |
| Depreciation for the financial year | 4.6 | 0.7 | 0.1 | 5.4 |
| Disposals | –1.3 | –0.5 | – | –1.8 |
| Disposals from the scope of consolidation | –0.8 | –0.4 | – | –1.2 |
| Currency translation differences | 0.1 | – | – | 0.1 |
| Balance as of 31 December 2023 | 18.1 | 1.3 | 0.4 | 19.8 |
| Depreciation for the financial year | 5.8 | 0.7 | 0.1 | 6.6 |
| Disposals | –0.4 | –0.5 | –0.1 | –1.0 |
| Disposals from the scope of consolidation | – | – | – | – |
| Currency translation differences | –0.5 | – | – | –0.5 |
| Balance as of 31 December 2024 | 23.0 | 1.5 | 0.4 | 24.9 |
| Carrying amount as of | ||||
| 31 December 2023 | 54.7 | 1.0 | 0.3 | 56.0 |
| 31 December 2024 | 54.7 | 1.2 | – | 55.9 |
The Biotest Group mainly leases plasma collection stations in Germany, Hungary, and the Czech Republic, as well as logistics and office buildings. The rental agreements relating to the plasma stations of Plasma Service Europe GmbH and to commercial and office premises of Biotest AG in Dreieich contain in part price adjustment clauses based on the consumer price index in Germany. Some of the rental agreements for the plasma collection stations of Plazmaszolgalát Kft. in Hungary and Cara Plasma s.r.o. in the Czech Re‐ public contain price adjustment clauses based on the "Harmonised Index of Consumer Prices" of the European Union (EUROSTAT HICP). In addition, rental agreements with extension, termination, and purchase options exist for the majority of the plasma stations in Germany and Hungary as well as for some of the offices and commercial premises at the Dreieich site; these options have terms of between 48 and 120 months. Please refer to section B 6 Leases for information about the assessment of the exercise of extension and termination options.
Longer‐term leases exist in particular for real estate, which represents the largest share of the carrying amount of the rights of use. The real estate contracts have residual terms of 1 to 19 years.
The rights of use of motor vehicles include the leased vehicle fleet. The lease agreements for motor vehicles have remaining terms of 1 to 5 years.
The rights of use for other facilities, office furniture, and equipment mainly relate to rental agreements for furniture, fixtures, and multifunction printers. The lease agreements have remaining terms of 1 to 3 years.
Depreciation of right‐of‐use assets for the financial year is included in the following items of the consolidated statement of income:
| in € million | 2024 | 2023 |
|---|---|---|
| Cost of sales | 3.8 | 3.0 |
| Marketing and sales costs | 0.5 | 0.7 |
| Administrative expenses | 2.3 | 1.7 |
| Research and development costs | – | – |
| 6.6 | 5.4 |
In the 2024 financial year, financial liabilities from leases of € 5.1 million (previous year: € 7.0 million) were repaid, and € 1.1 million (previous year: € 2.1 million) in interest for leases was paid. The total cash outflow from leases including variable lease payments and payments in connection with short‐term leases, as well as leases where the underlying asset is of low value, amounted to € 10.4 million in the 2024 financial year (previous year: € 9.3 million). Future cash outflows amounted to € 58.6 million as of the reporting date (previous year: € 57.9 million).
Potential future cash outflows of € 2.8 million (previous year: € 5.8 million) were not included in the lease liability as it is not reason‐ ably certain that the leasing agreements will be extended (or not be terminated). Leases entered into by the Biotest Group as lessee but not yet commenced give rise to potential cash outflows of € 2.5 million (previous year: € 3.8 million).
As of 31 December 2024, the Group was also obligated as part of short‐term lease agreements (term shorter than 12 months) for low‐value lease assets, for which the corresponding facilitation option is used. The total obligation from these agreements amounted to € 0.1 million as of that date (previous year: € 0.2 million).
The following amounts were recognised in profit or loss in the financial year:
| in € million | 2024 | 2023 |
|---|---|---|
| Depreciation charge for right‐of‐use assets | 6.6 | 5.4 |
| Interest expense on lease liabilities | 1.1 | 0.5 |
| Expense relating to leases of low‐value assets | 0.3 | 0.2 |
| Total value in income statement | 8.0 | 6.1 |
Information about the corresponding lease liabilities is provided in section E 15 Financial liabilities.
E 4 INVESTMENTS IN JOINT VENTURES
Investments in joint ventures relate to a 49 % interest held by Biotest Pharma GmbH in BioDarou P.J.S. Co., whose registered office is in Tehran, Iran, and which is equity accounted.
This company's purpose is to collect plasma, process it into immunoglobulins, factors, and human albumin via Biotest AG, and then sell the finished products in Iran.
The investment in BioDarou was impairment tested as of 31 December 2024, as an external valuation showed that the recoverable amount of this investment was below its carrying amount, which is an indication for a possible impairment in accordance with IAS 36.12.
The recoverable amount was determined as the value in use in accordance with IAS 36. The calculation was based on the discounted cash flow method (DCF method). The DCF method was applied with a detailed planning period of five years (2025‐2029). The valua‐ tion is based on the discounted future cash flows, taking into account current market conditions.
In addition, a multiples analysis (EV/EBITDA comparison with comparable companies) was carried out to check the plausibility of the valuation. Due to inflation, estimation uncertainties, and the geopolitical risks in Iran, a safety discount of 20 % was considered in the context of this plausibility check.
The recoverable amount was therefore weighted 80 % from the DCF method and 20 % from the multiple method.
Key assumptions and valuation methods:
- Detailed planning period: five years (2025‐2029)
-
Discount rate after corporate taxes and before shareholder taxes (WACC): 36.5 %
-
Discount rate of the terminal value: 30.3 %
- Terminal growth rate based on Iran's GDP and average inflation in Iran of 19.8 %: 22.7 %
- Multiples method: EV/EBITDA multiple of 8.0x (after 20 % discount)
- Exchange rate: 678,944 IRR/EUR
The expected cash flows are based on financial planning approved by management, considering risks common to the market and industry as well as the economic situation in Iran.
Due to the lower recoverable amount compared to the carrying amount, an impairment loss of € 9.7 million was recognised. After impairment, the carrying amount of this investment amounts to € 2.1 million.
Sensitivity analysis
The Group has carried out an analysis of the sensitivity of the impairment test to changes in the key assumptions for determining the recoverable amount. The sensitivity analysis shows that the recoverable amount reacts moderately to changes in the discount rate (WACC) and the terminal growth rate.
An increase in the discount rate of 1.0 percentage point would reduce the recoverable amount by € 0.1 million, resulting in an addi‐ tional impairment. A reduction in the terminal growth rate of 1.0 percentage point would reduce the recoverable amount by € 0.3 million.
Due to the inflation trend in Iran, since 2020 the joint venture based there has applied the regulations of IAS 29 Financial Re‐porting in Hyperinflationary Economies. The consolidated statement of financial position and the income statement have been adjusted in accordance with IAS 29 in order to calculate the share of net assets and of profit and loss. IAS 29 is to be applied retrospectively, that is, as if the hyperinflation had always existed. The financial statements were prepared on the basis of historical cost. As the restated financial statements are presented in Iranian rial, they are to be translated at the closing rate. As a consequence, the carrying amounts for non‐monetary assets and liabilities have been adjusted for changes in general purchasing power using the general price index both in the financial year under review and in the previous year. A consumer price index published by the International Mon‐ etary Fund was used for this purpose. The level of the index applied as of the 2024 reporting date was 1,210.4 (previous year: 896.6). The change in the index compared to the previous period was 35.0 %. In the previous period (2023 vs. 2022), the index increase was 48.2 %. Due to the restatement of the opening statement of financial position, an effect on the company's equity of 461.8 billion rials arose (previous year: 253.1 billion rials). As a result of the restatement of the opening statement of financial position, a foreign currency effect of € 2.2 million was recognised in other comprehensive income (previous year: € 1.1 million). The adjustment of the closing statement of financial position resulted in a further foreign currency effect of € 2.7 million recognised in other comprehensive income (previous year: € 2.8 million). Together with the recognised lossesfrom the current result from joint ventures of € ‐4.4 million (previous year: profit of € 2.8 million) and the loss from the impairment of the investment in BioDarou of € ‐9.7 million (previous year: € 0 million), the carrying amount of the investment in joint venture amounted to € 2.1 million as of 31 December 2024 (previous year: € 11.3 million).
The subscribed capital of BioDarou P.J.S. Co. amounted to 236.4 billion rials as of 31 December 2024 (previous year: 37.5 billion rials), excluding any adjustment as a result of IAS 29, and is fully paid in. BioDarou's share of Biotest's equity amounted to € 3.8 million as of 31 December 2024 (previous year: € 3.8 million).
As no audited financial statements of BioDarou P.J.S. Co. were available as of the time when these consolidated financial statements were prepared, the prior‐year figures of BioDarou P.J.S. Co. as of 31 December 2023 are reported.
The joint venture had the following assets and liabilities – without taking into consideration an adjustment due to IAS 29:
On 31 December 2023, the value of non‐current assets amounted to € 0.6 million (previous year: € 0.4 million) and the value of current assets amounted to € 47.8 million (previous year: € 29.0 million).
Non‐current liabilities were valued at € 2.4 million as of 31 December 2023 (previous year: € 1.6 million) and current liabilities at € 28.2 million (previous year: € 14.1 million).
In the 2023 financial year, the company's revenue amounted to € 69.9 million (previous year: € 18.8 million) and its net profit to € 4.6 million (previous year: € 5.8 million).
The joint venture had the following assets and liabilities – taking into consideration an adjustment due to IAS 29:
On 31 December 2023, the value of non‐current assets was € 4.1 million (previous year: € 2.7 million) and the value of current assets was € 50.5 million (previous year: € 36.8 million).
Non‐current liabilities were valued at € 2.4 million as of 31 December 2023 (previous year: € 1.6 million) and current liabilities at € 28.2 million (previous year: € 14.1 million).
In the 2023 financial year, the company's revenue amounted to € 81.1 million (previous year: € 21.4 million) and its net result to € ‐ 9.1 million (previous year: € 10.1 million).
The following financial information about the BioDarou joint venture is presented in euros, adjusted for inflation in accordance with IAS 29:
| in € million | 2023 | 2022 |
|---|---|---|
| Total assets | 54.6 | 39.5 |
| Total liabilities | 30.6 | 15.7 |
| Equity | 29.2 | 20.4 |
| Revenue | 81.1 | – |
| Profit (+)/loss (‐) | –9.1 | 5.7 |
| Dividend payments to equity holders | – | – |
| Cash flow from operating activities | –10.6 | –3.3 |
| Cash flow from investing activities | 2.5 | –2.8 |
| Cash flow from financing activities | 8.6 | 5.1 |
E 5 OTHER FINANCIAL ASSETS
| 2024 | 2023 | |||
|---|---|---|---|---|
| thereof | thereof | |||
| non‐ | non‐ | |||
| in € million | Total | current | Total | current |
| Cash deposit with banks (financial assets measured at amortised cost) | 11.4 | – | 10.4 | – |
| Receivable from trustee (financial assets measured at amortised cost) | 0.1 | – | 0.1 | – |
| Loan to third parties (financial assets measured at amortised cost) | 15.3 | 15.3 | 16.6 | 16.6 |
| Receivables from joint ventures (financial assets measured at amortised cost) | 0.4 | – | 0.4 | – |
| Securities (financial assets measured at amortized cost) | 0.3 | – | – | – |
| Other receivables (financial assets measured at amortised cost) | 1.6 | – | 0.2 | – |
| Derivative financial instruments (financial assets at fair value through profit or loss) | 0.1 | – | 0.2 | – |
| Pension fund (financial assets at fair value through profit or loss) | 0.1 | 0.1 | 0.1 | 0.1 |
| 29.3 | 15.4 | 28.0 | 16.7 |
The cash deposited with banks in the 2024 financial year, mainly for delivery, bid and tenant guarantees issued, is recognised at amortised cost. The amounts are subject to drawing restrictions.
Loans to third parties include long‐term loans to suppliers that were granted in connection with the construction of new plasma collection centres. As of 31 December 2024, the amount of these loans was € 15.3 million (previous year: € 16.6 million). These loans are directly related to the secured financing commitments that the Biotest Group has made to support suppliers in financing plasma collection centres (see also F 3 Financial risk management – Liquidity risk).
E 6 DEFERRED TAX ASSETS AND LIABILITIES
Deferred tax assets and liabilities relate to the following items in the consolidated statement of positions:
| Assets | Liabilities | Total impact on results | ||||
|---|---|---|---|---|---|---|
| in € million | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 |
| Intangible assets | – | – | 1.9 | 1.1 | 0.8 | –0.1 |
| Property, plant and equipment | 1.0 | 0.7 | 9.8 | 8.8 | – | –0.8 |
| Other financial assets | 2.5 | 1.9 | – | 0.8 | – | –0.1 |
| Inventories | 11.8 | 17.2 | 0.2 | 1.0 | 3.0 | –5.8 |
| Trade receivables | – | 0.3 | – | – | 0.3 | –0.6 |
| Contract assets | –10.4 | – | – | 15.0 | –4.5 | 4.5 |
| Deferred expenses | – | 0.1 | – | – | – | 0.2 |
| Other provisions | 3.5 | 1.1 | – | – | –2.5 | 0.2 |
| Financial liabilities | –0.2 | – | – | – | –0.5 | 0.7 |
| Pension provisions | 6.2 | 8.4 | –0.6 | – | 0.3 | –2.5 |
| Other liabilities | 0.6 | 1.4 | – | 0.7 | 1.4 | –1.6 |
| Contract liabilities | – | – | – | – | – | – |
| IFRS 16 | 0.6 | 7.5 | – | 7.1 | –0.2 | –0.3 |
| Other statement of financial position items | –0.3 | 0.1 | – | – | 1.9 | 0.1 |
| Tax value of the recognised loss carryforward and interest carryforward |
14.7 | 27.6 | – | – | 13.2 | –27.1 |
| Total deferred taxes | 29.8 | 66.3 | 11.4 | 34.5 | 13.1 | –33.2 |
| Less netting of deferred tax assets and liabilities | –10.3 | –33.4 | –10.3 | –33.4 | ||
| Deferred tax assets / liabilities | 19.6 | 32.9 | 1.1 | 1.1 |
As of 31 December 2024, the Group had usable tax loss carryforwards of € 41.9 million (previous year: € 81.3 million). These loss carryforwards are attributable to countries with a tax rate of 29.01 % (€ 38.9 million) and 9 % (€ 3.0 million) and deferred taxes were calculated at the respective individual tax rate.
Deferred taxes are not recognised for tax loss carryforwards of € 21.9 million (previous year: € 17.9 million), as the utilisation of these carryforwards in the near future is not reasonably certain at this time. Of the unrecognised loss carryforwards, none (previous year: € 0 million) relate to German companies and € 21.9 million (previous year: € 17.9 million) to foreign companies. In addition,
none (previous year: € 0 million) of the unrecognised loss carryforwards relate to unlimited carryforwards, € 13.5 million (previous year: € 11.5 million) can be carried forward for up to five years, and € 8.4 million (previous year: € 6.4 million) for five years or longer.
In contrast to the previous year, deferred tax assets are recognised for the domestic interest carryforward of € 12.3 million that existed as of 31 December 2024 (previous year: € 24.4 million), as it is also now likely that this interest carryforward will be utilised in the near future.
No material uncertain tax positions exist. For this reason, no detailed disclosures are required in accordance with IAS 12.88. In the Biotest Group, in some countries several years have not yet been definitively assessed by tax audits.
As of 31 December 2024, as in the previous year, no deferred tax liabilities were recognised for taxes on non‐distributed earnings of subsidiaries or joint ventures of the Biotest Group. The temporary differences in connection with shares in subsidiaries and joint ventures for which no deferred taxes are recognised amount to € 0.3 million (previous year: € 0.2 million). No deferred taxes are recognised on the temporary differences, as these will not reverse in the foreseeable future on the basis of current planning.
E 7 INVENTORIES
| in € million | 2024 | 2023 |
|---|---|---|
| Raw materials, consumables and supplies | 118.7 | 120.5 |
| Work in progress | 293.3 | 201.2 |
| Finished goods and merchandise | 67.5 | 97.4 |
| 479.5 | 419.1 |
As of the reporting date, the Biotest Group had no inventories with a term of more than one year, as in the previous year.
Cumulative impairment losses on inventories amounted to € 44.6 million as of the reporting date (previous year: € 95.5 million). Of the previous year'simpairment losses on inventories, € 13.2 million were utilised in the 2024 financial year (previous year: € 15.9 mil‐ lion), and € 48.4 million were reversed (previous year: € 0.3 million). This is primarily due to the following change in accounting estimate during the financial year: As a result of the recalculation of the plasma distribution key, which is essential for the allocation of production costs to joint products, consumption was determined according to the new production costs. The effects of the recal‐ culation for the valuation allowances made in the previous year were recognised in profit or loss in the reversal. Additions to, and reversals of, impairment losses on inventories are reported under cost of sales.
In addition, inventories were written down by € 10.7 million (previous year: € 48.0 million).
The accumulated impairment losses mainly comprised the write‐down in the amount of € 28.3 million applied to the plasmatic co‐ agulation Factor VIII due to the unfavourable market trend for drugs with coagulation factors (previous year: € 80.2 million). The plasma distribution key was recalculated in the 2024 financial year. Following the remeasurement, plasmatic coagulation Factor VIII haslower individual costs, which hasled to a decrease in the addition to the impairment. Moreover, the impairment of the plasmatic coagulation Factor VIII calculated with higher individual costs in the previous year were reversed in the 2024 financial year, which led to an increase in the reversal of impairments. The recalculation of the plasma distribution key represents a change in accounting estimates in accordance with IAS 8 (see also B 8 Inventories).
In the previous year, the impairment of inventories in the amount of € 47.7 million was reported in the cash flow statement under the "Changesin inventories, receivables and other assets" item. As of the 2024 financial year, it wasreclassified to the item "Reversal of write‐downs on inventories (write‐downs)", which is included in the operating cash flow before changes in working capital. The reclassification has been voluntarily carried out for the financial year 2024 and the comparative year 2023 in order to ensure a uniform presentation of the cash flow statement with the parent company of Biotest.
The total written‐down inventory, after being adjusted to the realizable net selling value, has a residual carrying amount of € 199.2 million (previous year: € 120.3 million).
Inventories expensed in the cost of sales amounted to € 465.8 million in the 2024 financial year (previous year: € 328.1 million).
E 8 TRADE RECEIVABLES
As in the previous year, none of the trade receivables totalling € 157.9 million (previous year: € 145.2 million) were classified as non‐ current. They are composed as follows:
| in € million | 2024 | 2023 |
|---|---|---|
| Trade receivables (gross) | 176.3 | 163.1 |
| Sale of trade receivables | –8.4 | – |
| Allowance for bad debts | –10.0 | –17.9 |
| Trade receivables (net) | 157.9 | 145.2 |
In the financial year, a retrospective adjustment of the impairments on trade receivables reported in the previous year amounting to € 0.9 million was made due to an adjustment in the notes to the financial statements. The primary financial statement compo‐ nents, such as the balance sheet, income statement, cash flow statements and statement of changes in equity are not affected by this correction. The adjustment in the comparative period 2023 increases gross trade receivables from € 162.2 million to € 163.1 million.
Net trade receivables include € 27.5 million (previous year: € 60.7 million) of receivables due from related parties. Receivables due from Grifols, S.A., as part of technology transfer and licensing agreements amounted to € 8.7 million as of 31 December 2024 (pre‐ vious year: € 47.9 million). The allowance for doubtful accounts is determined as the difference between the nominal amount of the receivables and the estimated net collectible amount. An impairment matrix was used to analyse receivables that do not exhibit any specific indications of impairment in individual cases, depending on the length of time they have been overdue. For customers in the Middle East region that are overdue by more than one year, the flat‐rate percentages were adjusted due to special default patterns.
As part of factoring agreements, Biotest AG had sold receivables with a total volume of € 8.4 million as of the reporting date (previous year: € 0.0 million). For Biotest AG, the factoring programme provides for the sale of domestic and foreign receivables, with an indi‐ vidual credit limit for each customer. Provided that the receivables are legally valid, the factor bears the risk of the customer's insol‐ vency for the receivables it purchases.
IT‐supported processes are in place to identify the trade receivables intended for factoring. These receivables are measured at fair value through profit or loss (FAFVtPL) due to the expected derecognition process. The fair value is calculated as the transaction price less a purchase price discount.
Allowances for expected credit losses for trade receivables show the following changes:
| in € million | 2024 | 2023 |
|---|---|---|
| Balance as of 1 January | 17.9 | 17.8 |
| Additions | 2.0 | 6.2 |
| Utilisation | – | – |
| Reversals | –9.8 | –6.1 |
| Balance as of 31 December | 10.0 | 17.9 |
As part of the retrospective adjustment, the year‐end 2023 balance of the reported impairment on receivables was corrected from € ‐17.0 million to € ‐17.9 million. In this context, the opening balance of impairment for 2023 was adjusted from € 16.7 million to € 17.8 million, an increase of € 1.1 million, while additions were corrected from € 6.4 million to € 6.2 million, a reduction of € 0.2 mil‐ lion.
The reversal of the impairment losses in the financial year resulted primarily from the settlement of overdue receivables from a business partner as part of an agreed payment plan. Due to the positive development of timely compliance with the payment plan, the previously recognised impairment losses were no longer necessary. The change in the allowance recognised in profit or loss is shown in the income statement under the item "Impairment losses and gains (including reversals of impairment losses) on financial assets and contract assets". In the previous year, the Impairment losses and gains were disclosed under other operating income and other operating expenses. In the financial year, a change in the presentation in accordance with IAS 1.41 was made for the change in the impairment in the financial year 2024 and in the comparative period.
The net change in value of the allowance for expected credit losses on trade receivables, which is attributable to receivables with an impaired credit rating, amounts to € 5.2 million in the financial year under review (previous year: € 15.5 million).
Net trade receivables are denominated in the following currencies:
| in € million | 2024 | 2023 |
|---|---|---|
| EUR | 114.6 | 113.1 |
| USD | 34.1 | 23.4 |
| GBP | – | 0.4 |
| HUF | 3.5 | 3.0 |
| BRL | 4.6 | 4.3 |
| Other currencies | 1.1 | 1.0 |
| Trade receivables (net) | 157.9 | 145.2 |
E 9 CONTRACT ASSETS
Contract assets from toll manufacturing amounting to € 36.0 million (previous year: € 51.6 million) relate to contingent claims for the complete fulfilment of contractual obligations from toll manufacturing agreements. The resulting performance obligations are generally fulfilled by Biotest over a period of up to twelve months. Receivables from this business, which usually have a due date of between 90 and 120 days, are recognised when the right to receive the consideration becomes unconditional. This is the case when the biological drugs produced from the blood plasma provided by the customer are delivered to the customer. These are service transactions that are valued at the corresponding costs of sales incurred plus profit margin, if reliably estimable. Contract assets decreased by € 15.6 million compared to the previous year, which is attributable to the quantitative decline in stocks from toll man‐ ufacturing. This change reflects the decrease in services rendered but not yet invoiced and corresponds to the pattern of service provision in accordance with IFRS 15.
They are composed as follows:
| in € million | 2024 | 2023 |
|---|---|---|
| Contract assets (gross) | 36.1 | 51.7 |
| Allowances for expected credit losses | –0.1 | –0.1 |
| Contract assets (net) | 36.0 | 51.6 |
Default risks are reflected by value adjustments. The allowances are calculated as the difference between the nominal amount of the contract assets and the estimated net recoverable amount. An impairment matrix was used to analyse portfolios of contract assets that do not exhibit any specific indications of impairment in individual cases, depending on the length of time they have been overdue.
The allowances for expected credit losses on contractual assets show the following changes:
| in € million | 2024 | 2023 |
|---|---|---|
| Balance as of 1 January | 0.1 | 0.3 |
| Additions | – | – |
| Utilisation | – | – |
| Reversals | – | –0.2 |
| Balance as of 31 December | 0.1 | 0.1 |
E 10 OTHER ASSETS
| 2024 | 2023 | |||
|---|---|---|---|---|
| in € million | Total | thereof non‐current |
Total | thereof non‐current |
| Value added and other tax receivables | 3.1 | – | 7.5 | – |
| Deferred income | 2.3 | 0.1 | 1.8 | – |
| Payments in advance | 1.6 | – | 9.2 | – |
| Receivables from plasma exchange transactions | 3.7 | – | – | – |
| Other assets | 2.1 | 0.1 | 2.8 | 0.1 |
| 12.8 | 0.2 | 21.3 | 0.1 |
Other assets mainly include refunds in connection with research grants amounting to € 1.3 million (previous year: € 2.1 million) as well as refunds for energy tax amounting to € 0.3 million (previous year: € 0.3 million).
The following picture emerges from the analysis of the age structure of other assets:
| in € million | 2024 | 2023 |
|---|---|---|
| Carrying amount | 12.8 | 21.3 |
| thereof unimpaired and not past due as of the reporting date | 12.8 | 21.3 |
| thereof unimpaired as of the reporting date and past due in the following time band | ||
| < 90 days past due | – | – |
As in the previous year, no valuation allowances were applicable to other assets in the 2024 financial year.
Other assets are denominated in the following currencies:
| in € million | 2024 | 2023 |
|---|---|---|
| EUR | 11.0 | 15.9 |
| USD | – | 3.5 |
| HUF | 1.1 | 1.0 |
| CZK | 0.6 | 0.8 |
| Other currencies | 0.1 | 0.1 |
| 12.8 | 21.3 |
E 11 CASH AND CASH EQUIVALENTS
| in € million | 2024 | 2023 |
|---|---|---|
| Bank balances | 107.6 | 107.9 |
| Cash on hand | 0.2 | 0.2 |
| 107.8 | 108.1 |
Please see the Biotest Group's consolidated statement of cash flows for details of changes in cash and cash equivalents.
In the 2024 financial year, payments of € 163.1 million were received from Grifols as part of technology transfer and licensing agree‐ ment (previous year: € 143.6 million).
In the 2024 financial year, Biotest AG made cash deposits with banks to secure its operating business. An amount of € 11.4 million was deposited as of 31 December 2024 (previous year: € 10.4 million). This amount is shown within other current financial assets as of 31 December 2024.
E 12 EQUITY
The subscribed capital is fully paid in and amounted to € 39,571,452 as of 31 December 2024 (previous year: € 39,571,452), of which € 19,785,726 (previous year: € 19,785,726) is attributable to ordinary shares and € 19,785,726 (previous year: € 19,785,726) to pref‐ erence shares. As of 31 December 2024, the subscribed capital was divided into 19,785,726 no‐par‐value ordinary shares with voting rights and 19,785,726 no‐par‐value preference shares without voting rights. Securitisation is not permitted. The notional par value of each share consequently amounts to € 1.00 for both share classes. Profit distributions in any financial year are based on the unappropriated net profit of Biotest AG as defined under the German Commercial Code (HGB).
The voluntary takeover offer by Grifols, S.A., published on 26 October 2021 for the shares of Biotest AG was effectively completed (the "closing") on 25 April 2022. Following the completion of the public tender offer and the closing of the acquisition of Tiancheng (Germany) Pharmaceutical Holdings AG, Grifols holds 96.20 % of the ordinary shares and 43.2 % of the preference shares, and thereby holds 69.72 % of the share capital of Biotest AG. On 2 May 2022, Grifols, S.A., announced pursuant to Section 23 (2) Sentence
1 of the German Securities Acquisition and Takeover Act (WpÜG) that Grifols, S.A., has acquired an additional 0.94 % of the voting rights in Biotest AG. As a consequence, Grifols, S.A., holds a total of 97.14 % of the voting rights in Biotest AG.
The proposal for the appropriation of profit envisages the distribution of a dividend of € 0.80 million for the year 2024 (previous year: € 1.60 million including the subsequent dividend payment of € 0.8 million for the 2022 financial year). A dividend of € 0.00 per share (previous year: € 0.00 per share) will be paid on the ordinary shares, and a dividend of € 0.04 per share (previous year: € 0.04 per share) on the preference shares.
In accordance with a resolution passed by the Annual General Meeting regarding dividend payments, preference shares are entitled to a preference dividend of € 0.04 per share. Furthermore, if holders of ordinary shares receive a dividend of more than € 0.03 per share, holders of preference shares receive an additional dividend of € 0.02 per share. If no dividend is paid on preference shares in one year, it is to be paid the following year. If a dividend is not paid in the second year, preference shares are to receive voting rights (cf. Section 140 (2) of the German Stock Corporation Act [AktG]).
As of 31 December 2024, the cumulative preference dividend not yet recognised the balance sheet amounted to € 0.8 million (pre‐ vious year: € 1.6 million including the subsequent payment of the € 0.8 million preference dividend for the 2022 financial year).
The authorised capital approved by the Annual General Meeting on 7 May 2019 expired on 6 May 2024. The Annual General Meeting on 7 May 2024 did not pass a resolution concerning the creation of new authorised capital or the corresponding amendment to the Articles of Association, as a consequence of which no authorised capital is currently available
The share premium account amounts to € 219.8 million (previous year: € 219.8 million) and includes premiums received from the issue of shares. Retained earnings amount to € 274.5 million (previous year: € 249.8 million) and result from retained profits. Other reserves amount to € ‐3.2 million (previous year: € ‐10.3 million) and include the currency translation reserve of € 5.3 million (previ‐ ous year: € 1.2 million) and the other comprehensive income after income taxes of € ‐8.5 million (previous year: € ‐11.5 million) resulting from the remeasurement of the defined benefit obligation.
The income tax effect of the remeasurement of defined benefit pension plans in the amount of € ‐0.2 million (previous year: € 0.8 million) was recognised in other reserves (see also the statement of comprehensive income and section D 10 Income taxes). This includes the income tax effect of € ‐0.9 million arising from the remeasurement of defined benefit pension plans in the 2024 financial year, and the € 0.7 million adjustment of the previous year's figures.
Diluted and basic earnings per share are calculated by dividing the profit attributable to shareholders of the parent company by the weighted average number of shares outstanding. Diluted earnings are equivalent to basic (undiluted) earnings at Biotest AG.
| in € million | 2024 | 2023 |
|---|---|---|
| Earnings after taxes | 26.4 | 127.0 |
| Additional dividend on preference shares | – | – |
| Profit adjusted for additional dividend rights | 26.4 | 127.0 |
| Number of shares outstanding (weighted average) | 39,571,452 | 39,571,452 |
| Basic and diluted earnings per ordinary share in € | 0.66 | 3.20 |
| Additional dividend rights per preference share in € | 0.02 | 0.02 |
| Basic and diluted earnings per preference share in € | 0.68 | 3.22 |
E 13 PROVISIONS FOR PENSIONS AND SIMILAR OBLIGATIONS
Benefits are based on the employee's length of service and salary. Retirement benefit obligations relate mainly to employees of the Group's German companies. Similar obligations are foreign obligations payable in a lump sum on retirement and obligations of the Biotest pension savings plan. These plans are voluntary pension plans not subject to statutory or legal obligations. The amount of the pension obligations is mainly dependent on interest rate movements and the life expectancy of the participants.
Assets of € 8.1 million (previous year: € 7.9 million) were held by a trustee, Biotest Vorsorge Trust e.V., in the 2024 financial year under a contractual trust arrangement (CTA) as external insolvency insurance for portions of the occupational pension scheme. As the transferred funds qualify as plan assets in accordance with IAS 19, provisions for pensions and similar obligations were netted with the transferred assets. As a consequence, provisions for pensions and similar obligations were reduced accordingly.
The net defined benefit liability comprises the following:
| in € million | 2024 | 2023 |
|---|---|---|
| Net present value of defined benefit obligations | ||
| From pension plans | 85.8 | 87.2 |
| From similar obligations | 14.2 | 11.8 |
| 100.0 | 99.0 | |
| Fair value of plan assets | ||
| For pension plans | 6.1 | 5.9 |
| For similar obligations | 2.2 | 2.0 |
| 8.3 | 7.9 | |
| Net defined benefit liability | ||
| From pension plans | 79.7 | 81.3 |
| From similar obligations | 12.0 | 9.8 |
| 91.7 | 91.1 |
The Biotest Group maintains defined benefit plans for eligible employees of its subsidiaries in Germany and, previously, for employ‐ ees of Biotest AG and Biotest Pharma GmbH. Through the plans in Germany, the Biotest Group is usually exposed to the following actuarial risks: investment risk, interest rate risk, longevity risk and salary risk.
The costs for the defined benefit plans consist of the following components:
| in € million | 2024 | 2023 |
|---|---|---|
| Current service cost | 4.7 | 5.2 |
| Net interest expenses | 3.0 | 3.4 |
| Total expenses recognised in profit and loss | 7.7 | 8.6 |
| Actuarial gains due to experience adjustments | –1.9 | –1.1 |
| Actuarial gains due to changes in financial assumptions (previous year loss) | –1.2 | 4.2 |
| Actuarial gains from changes in demographic assumptions | – | – |
| Return on plan assets (excluding amounts included in net interest expense) | –0.1 | –0.3 |
| Revaluations recognised directly in other comprehensive income | –3.2 | 2.8 |
| Defined benefit costs | 4.5 | 11.4 |
In the 2024 financial year, actuarial gains of € 3.2 million are recognised in other comprehensive income (previous year: losses of € 2.8 million). Of this amount, € 1.2 million resulted from changes in actuarial assumptions, which is mainly due to the increase in the actuarial interest rate in the main plans in Germany from 3.4 % to 3.5 %. In total, actuarial losses (before tax) of € 19.1 million (previous year: € 22.3 million) have been recognised in other comprehensive income.
The following table shows the reconciliation of the net present value of the defined benefit obligation (DBO):
| in € million | 2024 | 2023 |
|---|---|---|
| Net present value of defined benefit obligation as of 1 January | 99.0 | 91.5 |
| Change in consolidation group | – | –0.7 |
| Current service cost | 4.7 | 5.2 |
| Interest expense | 3.3 | 3.5 |
| Expenses recognised in the consolidated statement of income | 8.0 | 8.0 |
| Actuarial gains due to experience adjustments | –1.9 | –1.1 |
| Actuarial gains (previous year: losses) due to changes in financial assumptions | –1.2 | 4.2 |
| Actuarial gains due to changes in demographic assumptions | – | – |
| Revaluations recognised directly in the statement of comprehensive income | –3.1 | 3.1 |
| Pension benefits paid | –3.9 | –3.6 |
| Net present value of defined benefit obligation as of 31 December | 100.0 | 99.0 |
The following table shows the reconciliation of the fair value of plan assets:
| in € million | 2024 | 2023 |
|---|---|---|
| Fair value of plan assets as of 1 January | 7.9 | 5.7 |
| Interest income | 0.3 | 0.1 |
| Income recognised in the consolidated statement of income | 0.3 | 0.1 |
| Return on plan assets (excluding amounts included in net interest expenses) | 0.1 | 0.2 |
| Revaluations recognised directly in the statement of comprehensive income | 0.1 | 0.2 |
| Contribution by the employer | – | 1.9 |
| Payments from plan assets | – | – |
| Fair value of plan assets as of 31 December | 8.3 | 7.9 |
The following payments are expected to be made in subsequent years based on the current pension obligations:
| in € million | 2024 | 2023 |
|---|---|---|
| In the next 12 months | 6.5 | 5.2 |
| Between 2 and 5 years | 22.8 | 22.4 |
| Between 5 and 10 years | 30.4 | 31.3 |
| After 10 years | 116.9 | 113.7 |
| Total expected payments | 176.6 | 172.6 |
The weighted average term of the defined benefit plans is 11.7 years (previous year: 11.6 years) as of 31 December 2024.
Plan assets were invested in the following asset classes as of the reporting date:
| in € million | 2024 | 2023 |
|---|---|---|
| Cash and cash equivalents | 2.9 | 0.1 |
| Financial investment | 0.1 | 2.8 |
| Fund shares | 5.2 | 5.0 |
| 8.2 | 7.9 |
The plan assets transferred to Biotest Vorsorge Trust e.V are invested in accordance with defined investment principles, whereby the maturity or termination option of the financial instruments must always be selected in such a way that the association can meet its payment obligations. In accordance with the investment principles, the assets can be invested in euro time deposits as well as domestic government bonds, mortgage bonds, fund units in money market funds, or corporate bonds, each in euro. Loans can also be issued to Biotest Group companies against corresponding guarantees. A minimum rating of A‐ is required for all financial instru‐ ments. In the 2024 financial year, no contributions to plan assets were expected (previous year: € 0.0 million) and no contributions to plan assets are expected in the following year.
Of the provisions for pensions and similar obligations, € 100.0 million (previous year: € 99.0 million) relate to pension plans in Ger‐ many. The calculation of the German pension plans is based on the following actuarial assumptions:
| in % | 2024 | 2023 |
|---|---|---|
| Discount rate as of 31 December | 3,5 | 3,4 |
| Expected return on plan assets | 3.4 | 1.7 |
| Rate of increase for wages and salaries | 3.4 | 3.4 |
| Rate of interest for pensions | 2.0 | 2.0 |
| Employee turnover rate | 3.0 | 3.0 |
Actuarial assumptions are mainly based on historical empirical values with the exception of the discount rate.
As in the previous year, the calculation was based on the published Heubeck 2018 G mortality tables.
Under IAS 19.145, the effect of any possible changes to parameters for the underlying assumptions used to calculate the pension obligations must be disclosed in the sensitivity analysis. Only changesthat are realistically expected to occur in the following financial year are to be taken into consideration.
The actuarial rate of interest, salary trend, pension trend, and life expectancy are regarded as material assumptions. These parame‐ ters are shown in the following overview together with information on the parameter changes and their impact on the net present value calculation as of 31 December 2024.
| Parameter | Parameter change | Impact on the pension obligation in € million |
|---|---|---|
| Rate of interest | Increase by 50 basis points | –5.4 |
| Rate of interest | Decrease by 50 basis points | 6.0 |
| Salary trend | Increase by 50 basis points | 0.1 |
| Salary trend | Decrease by 50 basis points | –0.1 |
| Pension trend | Increase by 100 basis points | 6.3 |
| Pension trend | Decrease by 100 basis points | –5.4 |
| Life expectancy | Increase by one year | 3.1 |
An amount of € 13.2 million (previous year: € 11.8 million) was expensed for defined contribution plans in the financial year under review, and comprises the following items:
| in € million | 2024 | 2023 |
|---|---|---|
| Employer contributions to statutory pension scheme |
13.2 | 11.8 |
| 13.2 | 11.8 |
E 14 OTHER PROVISIONS
| in € million | Personnel‐ related provisions |
Litigation risks | Provisions for sales agreements |
Miscellaneous other provisions |
Total | thereof current |
|---|---|---|---|---|---|---|
| Balance as of 31 December 2023 | 10.9 | – | 13.5 | 3.5 | 27.9 | 23.1 |
| Change in consolidation group | – | – | – | – | – | |
| Additions | 9.9 | 0.2 | 1.6 | 0.6 | 12.3 | |
| Transfer | – | – | – | – | – | |
| Utilisation | –5.4 | – | –1.6 | –1.2 | –8.2 | |
| Reversals | – | – | – | – | – | |
| Balance as of 31 December 2024 | 15.4 | 0.2 | 13.5 | 2.9 | 32.0 | 18.2 |
Personnel‐related provisions mainly comprise provisions for profit‐sharing, severance payments, and the long‐term incentive (LTI) programme. The provisions under the LTI Programme are explained in detail in section F 1.
Additions to personnel provisions in the 2024 financial year mainly comprise additions of € 9.2 million (previous year: € 5.6 million) for profit sharing, severance payments, and the LTI programme for employees.
Provisions for sales contracts include provisions in connection with price moratoria and mandatory discounts as well as provisions for other risks with customers and disputed contractual penalties.
Other provisions include provisions for archiving costs, an obligation from a donation to a haemophilia foundation, and other items.
E 15 FINANCIAL LIABILITIES
| in € million | 2024 | 2023 |
|---|---|---|
| Non‐current liabilities | ||
| Subordinated shareholder loan | 336.6 | 329.5 |
| Shareholder loan | 201.9 | – |
| Other financial liabilities | 44.4 | 47.8 |
| Long‐term share of lease liabilities | 53.0 | 52.4 |
| 635.9 | 429.7 |
| in € million | 2024 | 2023 |
|---|---|---|
| Current liabilities | ||
| Shareholder loan | 0.2 | – |
| Other financial liabilities | 29.4 | 27.9 |
| Secured loans from financial institutions | – | 226.8 |
| Liabilities from derivative financial instruments | 0.8 | 0.1 |
| Short‐term share of lease liabilities | 5.5 | 5.4 |
| 35.9 | 260.2 |
The core of the financing of Biotest AG is formed by a subordinated, bullet, euro shareholder loan from Grifols Biotest Holdings GmbH with an original term until January 2025, which in March 2024 was extended until 2 January 2030. The contract modification was classified as a non‐material amendment in accordance with IFRS 9.5.4.3, as a consequence of which the liability was not derec‐ ognised and no material effects arise. The financial liability continues to be measured at amortised cost.
A further key component of the financing is a further euro shareholder loan from Grifols Worldwide Operations Limited (GWOL) with an original term until December 2024, which in December 2024 was extended until 31 December 2026. The contract modification was classified as a non‐material amendment in accordance with IFRS 9.5.4.3, as a consequence of which the liability was not derec‐ ognised and no material effects arise. The financial liability continues to be measured at amortised cost.
Other financial liabilities mainly include an unsecured long‐term loan of € 44.3 million (previous year: € 44.3 million), commission liabilities in connection with manufacturer discounts of € 22.8 million (previous year: € 18.4 million), and a repayment obligation from a supply contract of € 5.0 million (previous year: € 5.4 million).
The collateralised loan from financial institutions with a total volume of € 240 million was repaid in full in the 2024 financial year.
The liabilities from derivative financial instruments recognised under financial liabilities comprise derivatives held for the purpose of hedging currency risks.
Interest liabilities were reported together with the underlying loan on the basis of their due date.
Information about the hedging of foreign exchange rate and interest risks can be found in section F 3 Financial risk management.
The pricing and repayment terms as well as the maturity profile of financial liabilities are shown below:
| 2024 (in € million) | Total | Remaining term < 1 year |
Remaining term 1 to 5 years |
Remaining term > 5 years |
|---|---|---|---|---|
| Subordinated shareholder loans: | ||||
| EUR – fixed at 2.5 % | 336.6 | – | – | 336.6 |
| Shareholder loans: | ||||
| EUR – variable at 7,2 % | 151.6 | – | 151.6 | – |
| EUR – variable at 10,7 % | 50.5 | 0.2 | 50.3 | – |
| Secured loans from financial institutions: | ||||
| EUR – variable at 5.4 to 10.7 % | – | – | – | – |
| Other financial liabilities: | ||||
| EUR – fixed at 0.0 to 7.9 % | 73.3 | 29.0 | 44.3 | – |
| CZK – fixed at 0.0 % | 0.2 | 0.1 | 0.1 | – |
| Liabilities from derivative financial instruments | 0.8 | 0.8 | – | – |
| Lease liabilities: | ||||
| EUR – fixed at 0.0 to 5.8 % | 43.2 | 3.6 | 12.7 | 26.9 |
| HUF – fixed at 2.6 to 11.8 % | 10.3 | 1.2 | 4.2 | 4.9 |
| CZK – fixed at 1.1 to 6.1 % | 4.9 | 0.7 | 2.7 | 1.5 |
| CHF – fixed at 0.0 to 4.5 % | 0.1 | 0.1 | – | – |
| 671.5 | 35.7 | 265.9 | 369.9 |
The pricing and repayment terms as well as the maturity profile of the previous year's financial liabilities are shown below:
| 2023 (in € million) | Total | Remaining term < 1 year |
Remaining term 1 to 5 years |
Remaining term > 5 years |
|---|---|---|---|---|
| Subordinated shareholder loans: | ||||
| EUR – fixed at 2.5 % | 329.5 | – | 329.5 | – |
| Shareholder loans: | ||||
| EUR – variable at 7,2 % | – | – | – | – |
| EUR – variable at 10,7 % | – | – | – | – |
| Secured loans from financial institutions: | ||||
| EUR – variable at 5.4 to 7.9 % | 226.8 | 226.8 | – | – |
| Other financial liabilities | ||||
| EUR – fixed at 0.0 to 7.9 % | 75.5 | 27.8 | 3.4 | 44.3 |
| CZK – fixed at 0.0 % | 0.2 | 0.1 | 0.1 | – |
| Liabilities from derivative financial instruments | 0.1 | 0.1 | – | – |
| Lease liabilities: | ||||
| EUR – fixed at 0.0 to 6.0 % | 43.5 | 3.7 | 11.4 | 28.4 |
| HUF – fixed at 2.4 to 11.4 % | 9.5 | 1.0 | 3.7 | 4.8 |
| CZK – fixed at 0.9 to 6.8 % | 4.6 | 0.6 | 2.1 | 1.9 |
| CHF – fixed at 0.0 to 4.5 % | 0.2 | 0.1 | 0.1 | – |
| 689.9 | 260.2 | 350.3 | 79.4 |
Information about the corresponding right‐of‐use assets is provided in section E 3 Leases.
Net debt amounted to € 535.1 million as of the reporting date (previous year: € 551.5 million) and is derived as follows:
| in € million | 2024 | 2023 |
|---|---|---|
| Subordinated shareholder loans | 336.6 | 329.5 |
| Shareholder loans | 202.1 | – |
| Interest‐bearing financial liabilities to third parties | 45.7 | 272.3 |
| Lease liabilities | 58.5 | 57.8 |
| 642.9 | 659.6 | |
| Cash and cash equivalents | 107.8 | 108.1 |
| 107.8 | 108.1 | |
| Net debt | 535.1 | 551.5 |
Interest‐bearing financial liabilities to third parties consist of other interest‐bearing unsecured loans of € 45.7 million.
E 16 OTHER LIABILITIES
| in € million | 2024 | 2023 |
|---|---|---|
| Liabilities for commissions payable (contract manufacturing) | 2.4 | 4.7 |
| Deferred liabilities | 3.4 | 4.0 |
| Wage tax liabilities | 2.4 | 2.2 |
| Deferred income | 1.9 | 2.7 |
| Social security liabilities | 0.4 | 0.3 |
| Value added tax liabilities | 0.4 | 0.4 |
| Plasma swap liabilities related parties | – | 7.0 |
| Other liabilities | 3.8 | 1.6 |
| 14.7 | 22.9 |
As of the reporting date of the financial year under review, other liabilities amounting to € 0.7 million had a remaining term of more than one year (previous year: € 0.0 million).
F. OTHER DISCLOSURES
F 1 LONG‐TERM INCENTIVE PROGRAMME
Biotest AG pursues a business policy focused on the interests of shareholders based on a shareholder value principle that promotes long‐term growth in the value of the Biotest Group.
The Long‐term Incentive Programme (LTIP) includes certain employees who have a significant impact on the company's performance due to their position with the Group, their decisions, leadership, and actions.
No personal investment by the participant through the purchase of preferred shares of Biotest AG is required for the LTIPs 2021, 2022, 2023, and 2024. The targets of the LTIPs 2021, 2022, 2023 as well as 2024 are not dependent on the share price. Instead,share price‐independent targets are set. As a consequence, the 2021, 2022, 2023, and 2024 LTIPs do not have to be reported in accordance with IFRS 2.
The 2021, 2022, 2023, and 2024 LTIPs start in May of the first year and end on 31 December of the fourth year.
FURTHER GENERAL INFORMATION ON THE LTIP
Entitlement to an incentive payment ceases for the programme and all tranches if employment within the Biotest Group ends for any reason (other than retirement, early retirement, partial retirement, occupational disability or invalidity).
Participants receive a pro rata incentive payment in the event of a change of control in which at least 30 % of the voting rights are transferred to a shareholder who did not previously hold these voting rights, of a delisting from the stock market, or of a merger or
change in the legal status of the parent company, or if the company employing the participant leaves the group of companies in which the parent company holds a participating interest.
For a detailed description of the LTI programmes, please see our comments in the Remuneration Report of Biotest AG. This is avail‐ able on the Biotest website.
F 2 FINANCIAL INSTRUMENTS
F 2.1 CLASSIFICATION OF FINANCIAL INSTRUMENTS
The Biotest Group classifies financial instruments in accordance with its business model. Derivatives form a separate class in this context.
One class may contain several different items from the statement of financial position. The Biotest Group classifies financial instru‐ ments as follows:
The measurement categories under IFRS 9 are abbreviated as follows: financial assets measured at amortised cost (AC), financial assets measured at fair value through the other comprehensive income (FAFVtOCI), financial assets measured at fair value through profit and loss (FAFVtPL), financial liabilities measured at amortised cost (FLAC), and financial liabilities measured at fair value through profit and loss (FLFVtPL).
Lease liabilities (as defined in IFRS 16) do not fall within the scope of IFRS 9.
| Balance sheet item | Valuation class according to IFRS 9 |
|---|---|
| Trade receivables | AC |
| Other financial assets | AC |
| Cash and cash equivalents | AC |
| Trade receivables | FAFVtPL |
| Other financial assets | FAFVtPL |
| Financial liabilities | FLAC |
| Trade payables | FLAC |
| Lease liabilities (as defined by IFRS 16) | n/a |
| Other financial assets | FAFVtPL |
| Other financial liabilities | FLFVtPL |
F 2.2 RECONCILIATION OF STATEMENT OF FINANCIAL POSITION ITEMS TO MEASUREMENT CATEGORIES AS WELL AS THEIR MEASUREMENT BASIS AND FAIR VALUES
The Group measures financial instruments, such as derivatives, at fair value as of each reporting date. The fair values of financial instruments measured at amortised cost are listed in section F 2.3 Aggregation of measurement categories, including measurements and fair value.
Fair value isthe price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants at the measurement date. When measuring fair value, it is assumed that the transaction in which the sale of the asset or the transfer of the liability takes place takes place either
• in the principal market for the asset or liability, or
• in the most advantageous market for the asset or liability, if no principal market exists.
The Group must have access to the principal market or the most advantageous market.
The fair value of an asset or liability is measured using the assumptions that market participants would use in pricing the asset or liability. It is assumed that market participants act in their best economic interest.
In measuring the fair value of a financial asset, the market participant's ability to obtain economic benefits from the highest and best use of the asset or from its sale to another market participant that has the highest and best use of the asset is taken into considera‐ tion.
The Group uses valuation techniques that are appropriate in the circumstances and for which sufficient data is available to measure fair value. In doing so, the use of significant observable inputs is to be kept as high as possible and that of non‐observable inputs as low as possible.
According to IFRS 13.72, the financial instruments measured at fair value on the statement of financial position are to be classified in a three‐level hierarchy of fair value measurement. The level in each case reflects the market proximity of the data included in the determination of the fair value. The levels of the fair value hierarchy are described below:
Level 1: Quoted market prices for identical assets or liabilities in active markets.
Level 2: Information other than quoted market prices that is observable directly (e.g. prices) or indirectly (e.g. derived from prices).
Level 3: Information for assets and liabilities that is not based on observable market data.
For assets and liabilities that are recognised in the financial statements on a recurring basis, the Group determines whether transfers have occurred between levels in the hierarchy by reviewing the classification (based on the lowest level input that is significant to the fair value measurement as a whole) at the end of each reporting period.
In order to comply with the fair value disclosure requirements, the Group hasidentified groups of assets and liabilities based on their nature, characteristics, and risks, as well as the levels of the fair value hierarchy explained above.
In accordance with IFRS 7.29, it was assumed that the fair value of current financial instruments corresponds to the carrying amount, unless stated otherwise.
| Measurement basis in the statement of financial position according to IFRS 9 |
||||
|---|---|---|---|---|
| Carrying amount as of 31 December 2024 |
At amortised cost |
At fair value through profit or loss |
Fair value as of 31 December 2024 |
Fair value level |
| 19.2 | – | – | 19.2 | 2 |
| 0.1 | – | 0.1 | 0.1 | 2 |
| 0.1 | – | 0.1 | 0.1 | 2 |
| 0.1 | – | 0.1 | 0.1 | 1 |
| 19.4 | – | 0.2 | 19.4 | |
| 138.7 | 138.7 | – | 138.7 | – |
| 11.4 | 11.4 | – | 11.4 | 2 |
| 15.3 | 15.3 | – | 14.9 | 2 |
| 0.4 | 0.4 | – | 0.4 | – |
| 2.0 | 2.0 | – | 2.0 | 2 |
| 107.8 | 107.8 | – | 107.8 | 1 |
| 275.6 | 275.6 | – | 275.2 | |
| 0.8 | – | 0.8 | 0.8 | 2 |
| 0.8 | – | 0.8 | 0.8 | 2 |
| 0.8 | – | 0.8 | 0.8 | |
| 88.4 | 88.4 | – | 88.4 | – |
| 538.6 | 538.6 | – | 466.0 | 2 |
| 336.6 | 336.6 | – | 264.6 | 2 |
| – | – | – | – | – |
| 73.8 | 73.8 | – | 73.0 | 2 |
| 700.8 | 700.8 | – | 627.4 | |
| – | ||||
| 58.6 | – | – | – |
| in € million | Measurement basis in the statement of financial position according to IFRS 9 |
||||
|---|---|---|---|---|---|
| Item of the statement of financial position | Carrying amount as of 31 December 2023 |
At amortised cost |
At fair value through profit or loss |
Fair value as of 31 December 2023 |
Fair value level |
| Financial assets at fair value (FAFVtPL) | |||||
| Trade receivables | – | – | – | – | – |
| Derivatives without a hedging relationship | 0.2 | – | 0.2 | 0.2 | 2 |
| thereof from currency hedges | 0.2 | – | 0.2 | 0.2 | 2 |
| Pension fund | 0.1 | – | 0.1 | 0.1 | 1 |
| Total | 0.3 | – | 0.3 | 0.3 | |
| Financial assets measured at amortized cost (AC) | |||||
| Trade receivables | 145.2 | 145.2 | – | 145.2 | – |
| Cash deposits with banks | 10.4 | 10.4 | – | 10.4 | 2 |
| Loans to third parties | 16.6 | 16.6 | – | 16.6 | 2 |
| Receivables from joint ventures | 0.4 | 0.4 | – | 0.4 | – |
| Miscellaneous other financial assets | 0.3 | 0.3 | – | 0.3 | 2 |
| Cash and cash equivalents | 108.1 | 108.1 | – | 108.1 | 1 |
| Total | 281.0 | 281.0 | – | 281.0 | |
| Financial liabilities at fair value (FLFVtPL) | |||||
| Derivatives without a hedging relationship | 0.1 | – | 0.1 | 0.1 | 2 |
| thereof from currency hedges | 0.1 | – | 0.1 | 0.1 | 2 |
| Total | 0.1 | – | 0.1 | 0.1 | |
| Financial liabilities at amortized cost (FLAC) | |||||
| Trade payables | 78.1 | 78.1 | – | 78.1 | – |
| Shareholder loans | 329.5 | 329.5 | – | 325.6 | 2 |
| thereof subordinated shareholder loans | 329.5 | 329.5 | – | 325.6 | 2 |
| Secured loans from financial institutions | 226.8 | 226.8 | – | 232.3 | 2 |
| Other financial liabilities | 75.6 | 75.6 | – | 73.5 | 2 |
| Total | 710.0 | 710.0 | – | 709.5 | |
| Valuation in the statement of financial position according to IFRS 16 |
|||||
| Lease liabilities | 57.8 | – | – | – | – |
F 2.3 AGGREGATION OF MEASUREMENT CATEGORIES, INCLUDING MEASUREMENTS AND FAIR VALUE
Trade receivables(both sold and unsold) as well as cash and cash equivalents and other financial assets mainly have remaining terms of less than one year. For this reason, the carrying amounts at the reporting date correspond approximately to the fair values.
In the case of other non‐current receivables that are recognised under other financial assets and financial investments held to ma‐ turity, which consequently have remaining terms of more than one year, the fair values correspond to the present values of the payments associated with the assets, taking into consideration the respective current interest rate parameters which reflect market‐ and partner‐related changes in conditions and expectations. In addition to loans to third parties, other financial assets include, in particular, cash deposits and receivables from joint ventures.
The fair values of loans to third parties are determined as the present values of the payments associated with the receivables, based on the applicable yield curve and the credit spread curve for the individual currencies. The allocation of the fair value is based on hierarchy Level 2.
In the previous year, all remaining shares in ADMA Biologics Inc., which are measured at fair value, were divested.
Derivative financial assets and liabilities (foreign exchange transactions) are measured on a mark‐to‐market basis using quoted for‐ eign exchange rates and yield curves available in the market. The fair value is assigned to Level 2.
The fair value of the pension funds is allocated to Level 1.
Trade accounts payable and other current financial liabilities generally have remaining terms of less than one year. For this reason, the carrying amounts here also approximate the corresponding fair values.
The fair values of liabilities to shareholders and other non‐current financial liabilities are determined as the present values of the payments associated with the liabilities based on the applicable yield curve, as well as the credit spread curve for the individual currencies. The fair value is assigned to Level 2.
F 2.4 NET GAIN OR LOSS BY MEASUREMENT CATEGORY
The net gain or loss by measurement category is as follows for financial year 2024:
| in € million | From subsequent measurement | ||||||
|---|---|---|---|---|---|---|---|
| Categories | From interest | Currency At fair value translation |
Impairment | From disposal | Net gain/loss 2024 | ||
| Financial assets measured at amortised cost | 2.0 | – | 1.8 | 7.9 | – | 11.7 | |
| Financial assets measured at fair value through profit or loss |
– | –0.1 | – | – | – | –0.1 | |
| Financial liabilities measured at amortised cost | –32.2 | – | – | – | – | –32.2 | |
| Financial liabilities measured at fair value through profit or loss |
– | –2.4 | – | – | – | –2.4 | |
| Total | –30.2 | –2.5 | 1.8 | 7.9 | – | –23.0 |
The net gain or loss by measurement category is as follows for the previous financial year:
| in € million | From subsequent measurement | |||||
|---|---|---|---|---|---|---|
| Categories | From interest | At fair value | Currency translation |
Impairment | From disposal – |
Net gain/loss 2023 |
| Financial assets measured at amortised cost | 2.0 | – | –1.0 | 0.1 | 1.1 | |
| Financial assets measured at fair value through profit or loss |
– | –1.1 | – | – | – | –1.1 |
| Financial liabilities measured at amortised cost | –38.2 | – | –0.1 | – | – | –38.3 |
| Financial liabilities measured at fair value through profit or loss |
– | –0.1 | – | – | – | –0.1 |
| Total | –36.2 | –1.2 | –1.1 | 0.1 | – | –38.4 |
All components of the net gain or loss are recorded under other financial expenses or other financial income. Value allowances applied to trade receivables and other financial assets are exceptions in this context. These are reported in the change in valuation allowances on financial assets measured at amortised cost and presented separately in the income statement.
The result from the subsequent measurement of financial instruments allocated to the fair value through profit and loss measure‐ ment category includes a loss of € 2.5 million (previous year: loss of € 1.2 million), which includes both interest rate and currency effects.
F 2.5 CASH FLOW BY TIME BAND
The tables below show the contractually agreed, undiscounted interest payments, and principal repayments relating to primary financial liabilities and derivative financial instruments with positive and negative fair values. The second table contains comparative values for cash flows in specific periods based on the previous financial year.
This presentation includes all instruments that were in the portfolio on the reporting date and for which payments were already contractually agreed. It does not include budgeted figures for future new liabilities. Amounts denominated in foreign currencies are translated at the corresponding closing rate. The variable interest payments from the financial instruments are calculated on the basis of the interest rates last fixed before 31 December 2024. Financial liabilities repayable on demand are always allocated to the earliest time period.
| in € million | Cash flow in 2025 | Cash flow in 2026 | |||||
|---|---|---|---|---|---|---|---|
| Balance sheet items | Carrying amount as of 31 December 2024 |
Fixed interest |
Variable interest |
Principal repayment s |
Fixed interest |
Variable interest |
Principal repayment s |
| Primary financial liabilities: | |||||||
| Liabilities to shareholders | –538.6 | – | –5.5 | – | – | –33.5 | –197.3 |
| Liabilities to banks | – | – | – | – | – | – | – |
| Liabilities to fianancial instututions | – | – | – | – | – | – | – |
| Lease liabilities | –58.6 | –1.7 | – | –5.5 | –1.6 | – | –5.1 |
| Other financial liabilities | –73.7 | –3.5 | – | –28.3 | –3.5 | – | –0.1 |
| Trade payables | –88.4 | – | – | –88.3 | – | – | – |
| Derivative financial liabilities: | |||||||
| Foreign exchange derivatives without hedge relationships | –0.8 | – | – | –0.8 | – | – | – |
| in € million | Cash flow in 2024 | Cash flow in 2025 | ||||||
|---|---|---|---|---|---|---|---|---|
| Balance sheet items | Carrying amount as of 31 December 2023 |
Fixed interest |
Variable interest |
Principal repayment s |
Fixed interest |
Variable interest |
Principal repayment s |
|
| Primary financial liabilities: | ||||||||
| Liabilities to shareholders | –329.5 | – | – | – | –47.3 | – | –290.0 | |
| Liabilities to banks | – | – | – | – | – | – | ||
| Liabilities to financial institutions | –226.8 | – | –17.4 | –225.0 | – | – | – | |
| Lease liabilities | –57.8 | –1.9 | – | –5.4 | –2.7 | –0.8 | –2.7 | |
| Other financial liabilities | –75.6 | –3.5 | –0.9 | –26.9 | –3.5 | – | –3.4 | |
| Trade payables | –78.1 | – | – | –78.1 | – | – | – | |
| Derivative financial liabilities: | ||||||||
| Foreign exchange derivatives without hedge relationships | –0.1 | – | – | –0.1 | – | – | – |
| Cash flow in 2027 | Cash flow in 2028 | Cash flow in 2029 | Cash flow nach 2029 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Fixed interest |
Variable interest |
Principal repayments |
Fixed interest |
Variable interest |
Principal repayments |
Fixed interest |
Variable interest |
Principal repayments |
Fixed interest |
Variable interest |
Principal repayments |
| – | – | – | – | – | – | – | – | – | –83.5 | – | –290.0 |
| – | – | – | – | – | – | – | – | – | – | – | – |
| – | – | – | – | – | – | – | – | – | – | – | – |
| –1.4 | – | –5.0 | –1.3 | – | –4.9 | –1.2 | – | –4.7 | –7.1 | – | –33.3 |
| –3.5 | – | – | –0.3 | – | – | –4.3 | – | –44.3 | – | – | – |
| – | – | – | – | – | – | – | – | – | – | – | – |
| – | – | – | – | – | – | – | – | – | – | – | – |
| Cash flow in 2026 | Cash flow in 2027 | Cash flow in 2028 | Cash flow after 2028 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Fixed interest |
Variable interest |
Principal repayments |
Fixed interest |
Variable interest |
Principal repayments |
Fixed interest |
Variable interest |
Principal repayments |
Fixed interest |
Variable interest |
Principal repayments |
| – | – | – | – | – | – | – | – | – | – | – | – |
| – | – | – | – | – | – | – | – | – | – | – | – |
| –3.5 | – | – | –3.5 | – | – | –3.5 | – | – | – | – | –44.3 |
| –1.5 | – | –4.3 | –1.4 | – | –4.2 | –1.3 | – | –4.1 | –8.5 | – | –35.1 |
| – | – | – | – | – | – | – | – | – | – | – | – |
| – | – | – | – | – | – | – | – | – | – | – | – |
| – | – | – | – | – | – | – | – | – | – | – | – |
F 3 FINANCIAL RISK MANAGEMENT
In the course of its ordinary operations and due to existing international trade relationships, Biotest is exposed to currency and interest rate risks as well as credit and liquidity risks.
To hedge currency positions, Biotest uses derivative financial instruments to minimise risks inherent in exchange rate fluctuations. The hybrid loan with embedded derivativestaken outin 2021 wasfully repaid in the 2024 financial year. Other contracts are reviewed for hybridity. If they contain a derivative, and the corresponding accounting requirements for separating the derivative financial instrument are met, this is measured separately. Derivative financial instruments are generally subject to changes in market prices.
Biotest does not apply hedge accounting. Consequently, all gains and losses arising from market valuation of derivative financial instruments used to hedge interest rate and currency risks are recognised through profit or loss.
Financial instruments are recognised at the time that the corresponding contracts are concluded. The financial instruments are orig‐ inally recognised at fair value and subsequently measured in accordance with the classification. Financial instruments are derecog‐ nised once contractual obligations have been fulfilled by both parties, or upon the closing out of the instrument.
The market values of the derivative financial instruments are reported on the statement of financial position under other finan‐cial assets or financial liabilities. As of 31 December 2024, € 0.1 million (previous year: € 0.2 million) are reported under other financial assets, and € 0.8 million (previous year: € 0.1 million) under financial liabilities.
CREDIT RISK
A credit risk is the financial risk that a contractual partner will not meet its payment obligations. Default risk is countered through continuous receivables management. The customer's credit rating is assessed, and credit terms and other conditions are subse‐ quently defined. In addition, some of the domestic and foreign receivables are sold to factoring companies or banks.
Of the trade receivables, € 44.0 million (previous year: € 13.5 million) relate to net receivablesfrom customersin Iran. The underlying gross receivables are subject to impairments of € 4.2 million (previous year: € 1.1 million).
Credit insurance policies have been taken out with various companies for certain customers in selected countries. Economic risks are insured for an amount of € 22.2 million (previous year: € 22.2 million), and political risksfor an amount of € 22.2 million (previous year: € 22.8 million). The deductible agreed as part of existing credit insurance policies amounts to up to 5 %. In the financial year 2024, receivables amounting to € 3.1 million (previous year: € 16.7 million) were written down, although collateral existed for these receivables in the context of credit insurance. The amount written down is € 0.2 million (previous year: € 0.1 million). In the course of determining the expected credit losses, existing credit balances for individual customers in the amount of € 0.7 million (previous year: € 0.7 million) were considered collateral and netted against the existing receivables.
In both the 2024 financial year and the previous year of 2023, no receivables were written off in full for which legal or contractual measures to recover them are still in progress.
Potential default risks for primary financial instruments that are not held at fair value through profit or loss are taken into consider‐ ation through value adjustments for expected credit losses due to ratings with or without increased credit risk.
Expected losses for other financial assets and cash and cash equivalents are of minor significance for the Group.
To present the maximum default risk of primarily financial assets, the corresponding carrying amount is used as an equivalent for the maximum default risk:
| in € million | 2024 | 2023 |
|---|---|---|
| Trade receivables | 157.9 | 145.2 |
| Contract assets | 36.0 | 51.6 |
| Cash and cash equivalents | 107.8 | 108.1 |
| Other financial assets | 29.3 | 28.0 |
To cover the default risk, corresponding value adjustments are made in the amount of the expected credit default in accordance with IFRS 9.5.5. The simplified approach is mainly used for trade receivables. For this purpose, probabilities of default are calculated for individual customers or customer groups on the basis of the customer's historical payment behaviour using an impairment matrix. In the impairment matrix,the expected loss overthe remaining term is calculated as a flat‐rate percentage depending on the duration of the overdue period and, if necessary, adjusted to reflect current conditions and expectations of future economic and business
trends. In the event of default patterns that diverge significantly from the impairment matrix based on overdue amounts, the per‐ centages are adjusted taking region‐specific factors into consideration.
Based on the risk classifications, the carrying amounts per overdue are shown below:
| in € million | Loss rate | Gross carrying amount |
Impairment loss allowance |
Credit impaired |
|---|---|---|---|---|
| 31 December 2024 | ||||
| Trade receivables | 140.6 | –10.0 | ||
| Current (0‐30 days past due) | 0.19% | 86.4 | –0.2 | No |
| 31‐60 days past due | 0.62% | 5.2 | – | No |
| 61‐90 days past due | 2.03% | 6.1 | –0.1 | No |
| 91‐180 days past due | 3.01% | 10.4 | –0.3 | No |
| 181‐365 days past due | 8.52% | 11.9 | –1.0 | No |
| More than 365 past due | 20.92% | 15.3 | –3.2 | No |
| Loss | 98.11% | 5.3 | –5.2 | Yes |
| Contract assets | 36.1 | –0.1 | ||
| Current (0‐30 days overdue) | 0.19% | 36.1 | –0.1 | No |
| Cash and cash equivalents | 107.8 | – | ||
| Other financial assets | 29.3 | – | ||
| Total | 313.8 | –10.1 | ||
| in € million | Loss rate | Gross carrying amount |
Impairment loss allowance |
Credit impaired |
|---|---|---|---|---|
| 31 December 2023 | ||||
| Trade receivables | 102.4 | –17.9 | ||
| Current (0‐30 days past due) | 0.19% | 67.6 | –0.1 | No |
| 31‐60 days past due | 0.62% | 3.5 | – | No |
| 61‐90 days past due | 2.03% | 0.7 | – | No |
| 91‐180 days past due | 3.01% | 2.4 | –0.1 | No |
| 181‐365 days past due | 8.52% | 2.9 | –0.2 | No |
| More than 365 past due | 38.30% | 4.7 | –1.8 | No |
| Loss | 76.21% | 20.6 | –15.7 | Yes |
| Contract assets | 51.7 | –0.1 | ||
| Current (0‐30 days overdue) | 0.19% | 51.7 | –0.1 | No |
| Cash and cash equivalents | 108.1 | – | ||
| Other financial assets | 28.0 | – | ||
| Total | 290.2 | –18.0 | ||
In the financial year, a retrospective adjustment of the impairments on trade receivables reported in the previous year amounting to € 0.9 million was made due to an adjustment in the notes to the consolidated financial statements. As part of this adjustment, the year‐end 2023 balance of the reported impairments on receivables was corrected from € ‐17.0 million to € ‐17.9 million. Further details can be found in section E 8 Trade receivables.
Biotest categorises all the assets listed above into groups based on an impairment matrix depending on the length of time overdue (for trade receivables and contract assets) or based on the credit rating and origin of the respective debtor (for other financial assets and cash and cash equivalents), and recognises impairment allowances ranging from 0.19 % to 100 %. Individual value adjustments are also made for receivables with increased credit risk, which can be up to 100 % due to impending insolvency, for example.
The Biotest Group does not hold any assets that are impaired upon initial recognition or upon settlement (purchased or originated credit impaired, POCI).
MARKET RISK
Market risk arises from changes in market prices. These lead to fluctuations in fair values or future cash flows from financial instru‐ ments. Market risk comprises foreign exchange risk, interest rate risk, and other price‐related risk.
CURRENCY RISK
The Biotest Group operates internationally and is consequently exposed to foreign currency risk based on the exchange rates of different foreign currencies, primarily the US dollar. In addition, foreign currency risks exist arising from leasing contracts concluded in foreign currencies (mainly HUF). Foreign currency risks arise from expected future transactions, recognised assets and liabilities, and net investments in foreign operations. As a matter of principle, the Biotest Group protects itself against identifiable future cur‐ rency risk whenever it anticipates such exposure. In addition, risks relating to the balance sheet (statement of financial position) are hedged selectively. The Biotest Group makes use of opportunities to offset currency risk naturally and to use currency futures to manage currency risk.
The Biotest Group holds the following positions in foreign currencies that are material to the Group:
| Foreign currency risk | USD | HUF | CAD | |||
|---|---|---|---|---|---|---|
| in € million | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 |
| Cash and cash equivalents | 25.7 | 2.0 | 1.7 | 2.4 | – | – |
| Trade receivables | 34.1 | 23.4 | 3.5 | 3.0 | – | – |
| Other primary financial assets | 5.7 | 2.3 | 0.3 | 0.1 | 9.5 | – |
| Other derivative financial assets | – | 0.1 | – | – | – | – |
| Trade payables | –0.4 | –14.9 | –1.1 | –1.0 | –8.1 | –3.0 |
| Lease liabilities | – | – | –10.4 | –0.7 | – | – |
| Other primary financial liabilities | –10.3 | –10.4 | – | – | – | – |
| Other derivative financial liabilities | – | – | – | – | – | – |
| Net position | 54.8 | 2.5 | –6.0 | 3.8 | 1.4 | –3.0 |
Due to the divestiture of Biotest (UK) Ltd. in the 2023 financial year, the importance of GBP as a foreign currency for the Biotest Group has diminished.
The following currency futures for the sale of USD and CAD (previous year: USD, TRY, and CAD) were held as of the reporting date:
| in € million | Nominal amount | Market values | ||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Forward exchange transactions | 45.8 | 21.9 | –0.7 | 0.1 |
See section B 3 for information about the main exchange rates during the reporting period.
INTEREST RATE RISK
The Biotest Group's interest rate risk arises from current and non‐current financial liabilities. Loans with variable interest rates ex‐ pose the Group to interest‐related cash flow risks. Fixed‐rate loans give rise to an interest‐related risk from changes in fair value.
As in the previous year, no interest rate hedging transactions existed as of 31 December 2024.
LIQUIDITY RISK
Liquidity risk is the risk that a company will be unable to meet its financial commitments to a sufficient extent at all times. A shortage of financial capital could lead to higher financing costs.
The Biotest Group finances itself through shareholder loans, short‐term loans from financial institutions, factoring and other loans, and leasing agreements (previous year: shareholder loans, short‐term loans from financial institutions and leasing agreements).
At the end of the reporting period, the Biotest Group had the following agreed credit lines:
| in € million | 2024 | 2023 |
|---|---|---|
| Loans drawn down | 613.2 | 633.9 |
| Loans not drawn down | – | 15.0 |
As of 31 December 2024, the Biotest Group had issued secured financing commitments to suppliers in the amount of € 27.3 million (previous year: € 26.9 million), of which € 19.5 million (previous year: € 17.3 million) had been utilised. These financing commitments are related to the support for the construction of new plasma collection centres and include the provision of loans by Biotest to the
supplier. The total term of the loans is five years after the first tranche is drawn. The amounts drawn bear interest at a fixed rate of 4.0 %, 4.5 % or 5.0 % p.a. The agreements include a two‐year or three‐year interest‐only period after the first draw, during which only the interest at the beginning of the month is capitalised. After the two‐year or three‐year interest capitalisation period, annuity repayments are made monthly at the same time as further interest capitalisation until the end of the loan term. The final maturities of the loans granted are 2026 and 2027.
In order to reduce potential liquidity risks, the individual corporate divisions supply Group Treasury with the necessary information to create a liquidity profile. All financial assets, financial liabilities, and anticipated payment flows from planned transactions are included in the liquidity profile.
A maturity overview illustrating how cash flows from liabilities as of 31 December 2024 impact the Group's liquidity position is pro‐ vided in section F 2.
| in € million | 1 January 2024 | Cash flows from financing activities |
New leases (not cash‐effective) |
Exchange rate changes |
Other 31 December 2024 | |
|---|---|---|---|---|---|---|
| Financial liabilities | 632.0 | –27.4 | – | – | 8.6 | 613.2 |
| Lease liabilities | 57.8 | –5.1 | 7.6 | –1.0 | –0.7 | 58.6 |
| Total | 689.8 | –32.5 | 7.6 | –1.0 | 7.9 | 671.8 |
The changes in liabilities from financing activities are as follows:
| in € million | 1 January 2023 | Cash flows from financing activities |
New leases (not cash‐effective) |
Exchange rate changes |
Other 31 December 2023 | |
|---|---|---|---|---|---|---|
| Financial liabilities | 615.1 | –24.1 | – | – | 41.1 | 632.1 |
| Liabilities from leases | 29.0 | –9.0 | 41.2 | – | –3.4 | 57.8 |
| Total | 644.1 | –33.1 | 41.2 | – | 37.7 | 689.9 |
Cash flows from financing activities mainly include cash inflows from borrowings of financial liabilities in the amount of € 197.4 million (previous year: € 10.1 million) and cash outflows for the repayment of financial liabilities in the amount of € 225.1 million (previous year: € 12.0 million) as well as repayments of lease liabilities.
The other changes include non‐cash movements and accrued but not yet paid interest on interest‐bearing loans and interest liabili‐ ties in financial liabilities.
The Biotest Group classifies interest paid as cash flow from operating activities.
F 4 SENSITIVITY ANALYSIS PURSUANT TO IFRS 7.40
The Biotest Group is exposed to market risks comprising currency risks, interest rate risks, and other price risks. The disclosures relating to the sensitivity analysis in accordance with IFRS 7.40b include both the fair value risk and the cash flow risk.
By using sensitivity analyses, the effects of any changes in the relevant risk variables on profit or loss and equity as of the reporting date are determined for each type of risk.
CURRENCY RISK
A sensitivity analysis is performed to analyse the currency risks for certain foreign currencies with a significant risk for the Biotest Group. The currencies USD, HUF, and CAD are considered separately.
Based on a total exposure of € 64.7 million (previous year: € 8.2 million), the currency sensitivitiesresult in the following hypothetical impact on earnings:
| in million € | Appreciation of EUR of 10 % |
Depreciation of EUR of 10 % |
|||
|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | ||
| EUR to USD | 5.0 | 1.1 | –6.1 | –1.1 | |
| EUR to HUF | 0.4 | 0.4 | –0.5 | –0.5 | |
| EUR to CAD | 0.1 | 0.8 | –0.1 | –0.7 | |
| EUR to other exchange rates | 0.4 | 0.3 | –0.5 | –0.5 | |
| 5.9 | 2.6 | –7.2 | –2.8 |
It should be noted that the sensitivity analysis required by IFRS 7 only takes into consideration exchange rate risk on financial assets and liabilities but not translation risk. If translation risk had been taken into consideration, the effect would have been different.
INTEREST RATE RISK
For interest rate risk, a sensitivity analysis serves to illustrate the effects of changes in market interest rates on interest income and expenses, other income components and, where applicable, equity.
Changes in the market interest rates of primary financial instruments with fixed interest rates only impact income if they are recog‐ nised at fair value. Financial instruments with fixed interest rates measured at amortised cost are consequently not exposed to interest rate risk as defined by IFRS 7.
Currency derivatives and changes in their value due to interest rate changes were not taken into consideration in calculating interest rate sensitivities.
The sensitivity analysis is based on the net effect of interest‐bearing liabilities, bank balances, and current financial assets.
| in million € | Increase in interest rate structure of 100 BP | |
|---|---|---|
| 2024 | 2023 | |
| from primary financial instruments | 1.2 | –1.1 |
| Total hypothetical impact on results | 1.2 | –1.1 |
| in million € | Decrease in interest rate structure of 100 BP | |
| 2024 | 2023 | |
| from primary financial instruments | –1.2 | 1.1 |
| Total hypothetical impact on results | –1.2 | 1.1 |
If the market interest rate level as of 31 December 2024 had been 100 basis points higher or 100 basis points lower, equity would have remained unchanged. Please see the remarksin section E 13 for changesin equity due to actuarial gains and lossesfrom pension plans.
OTHER PRICE‐RELATED RISK
As part of the presentation of market risk, IFRS 7 also requires information about how hypothetical changes in risk variables affect the prices of financial instruments. In particular, equity market prices or indices can be considered as risk variables.
Other price‐related risks have no material impact on the prices of financial instruments held by the Biotest Group.
F 5 CAPITAL MANAGEMENT
The primary objective in managing capital is to ensure an attractive overall rating for investors and to maintain adequate capital ratios in order to secure the Biotest Group's strategic business development and growth.
The Biotest Group's equity on which capital structure optimisation efforts focus is the equity reported on the statement of financial position that is attributable to the owners of Biotest AG as the parent company. The share capital consists of 19,785,726 ordinary voting shares and 19,785,726 non‐voting preference shares.
Strategic capital management analyses are based on long‐term forecast calculations, which are used to determine the corresponding future values and indicators. In the short term, budget forecasts for the following year serve as the basis for financial indicators.
As part of its strategy, the Biotest Group seeks to maintain an equity ratio of at least 40 %. The equity ratio of the Biotest Group as of 31 December 2024 amounts to 37.0 % (previous year: 35.4 %). The main reasons for this are the impact of the Biotest Next Level expansion project on earnings and the raising of additional debt capital. In addition, both long‐term and quarterly special financial ratios are used for analysis and management purposes. The key figures in this context are adjusted EBIT and net debt.
No fundamental changes were made to the objectives or processes for managing capital in the 2024 financial year. An adequate organisational structure as well as defined workflows and monitoring processes were implemented for the necessary controlling of the Biotest Next Level project and the financial resources it requires.
The Biotest Group has various options at its disposal for achieving its capital management objectives. These include capital increases through the issue of new shares with or without pre‐emptive rights, dividend policies, and the repurchase of shares. Efforts to opti‐ mise the capital structure are supported by the active management of working capital.
Biotest AG implemented a capital increase in June 2013. The maximum possible number of 1,461,909 new preference shares was subscribed for at a price of € 52 per share either by existing shareholders using their subscription rights or by way of placement with institutional investors. New no‐par‐value bearer preference shares with a proportionate amount of the share capital of € 2.56 per share were issued. This generated gross issue proceeds of € 76 million.
The main financing is provided by a shareholder loan from Grifols Holdings GmbH, Frankfurt am Main, Germany, in the no‐minal amount of € 290.0 million, which was extended on 15 March 2024 until 2 January 2030. The shareholder loan is subordinated and ranks behind senior liabilities and all other non‐subordinated liabilities of Biotest AG. The shareholder may not assert its claims under this agreement for as long as this would result in the insolvency or over‐indebtedness of the borrower.
To cover further financing requirements in 2024, Biotest AG and Grifols Worldwide Operations Limited, Dublin, Ireland, a wholly owned subsidiary of Grifols, S.A., concluded a € 147.0 million financing agreement on 7 March 2023, the entirety of which was uti‐ lised in the 2024 financial year. On 20 December 2024, this agreement was extended until 31 December 2026. In addition, in the fourth quarter 2024, financing of € 50.3 million was raised from Grifols Worldwide Operations Limited, Dublin, Ireland.
Moreover, a letter of comfort was signed on 20 December 2024 between Biotest AG and Grifols, S.A., to secure the liquidity require‐ ments of Biotest AG, which is limited until 31 December 2026. In the event of imminent over‐indebtedness or insolvency of Biotest AG, there is an immediate claim to payment which guarantees financial support. The letter of comfort therefore represents a legally binding commitment to provide capital.
Further information is provided in section E 15 Financial liabilities.
F 6 CONTINGENT ASSETS AND CONTINGENT LIABILITIES
A contingent liability of € 5.1 million (previous year: € 5.1 million) exists in the context of an ongoing antitrust case in Romania.
Cash deposits of € 11.4 million (previous year: € 10.4 million) were made as collateral with banks.
Contingent liabilities of € 1.3 million (previous year: € 1.8 million) exist from collateral for liabilities to third parties.
As in the previous year, no contingent assets existed as of the reporting date.
F 7 OTHER FINANCIAL COMMITMENTS
| in € million | in 2025 | 2026 to 2029 | starting in 2030 |
Total |
|---|---|---|---|---|
| Commitments under longterm supply agreements with fixed purchase volumes |
270.0 | 500.6 | – | 770.6 |
| Commitments under longterm service agreements | 6.7 | 7.2 | – | 13.9 |
| Other financial obligation | 3.8 | 12.6 | 2.7 | 19.1 |
| 280.5 | 520.4 | 2.7 | 803.6 |
The other financial commitments comprise plasma supply contracts with a volume of € 760.8 million (previous year: € 875.0 million). These contracts include obligations for the purchase of plasma by Biotest AG. The amount of the obligations depends on the availa‐ bility of the natural resource plasma (willingness of the population to donate). Commitments under long‐term supply agreements
for intermediates with fixed purchase volumes relate to supply agreements for the years 2025 to 2026, under which Biotest is to receive products worth € 9.6 million (previous year: € 10.0 million) in subsequent years.
Obligations under long‐term service agreements mainly relate to purchase commitments under two toll manufacturing agreements for the periods from 2025 to 2026 totalling € 13.9 million (previous year: € 14.4 million).
F 8 OTHER RELATED PARTIES TRANSACTIONS
The relationships between Biotest AG and its consolidated subsidiaries, which are related parties, were eliminated in the course of consolidation and are not discussed in these notes. Related parties of the Biotest Group include Grifols Biotest Holdings GmbH as the direct parent company, Grifols, S.A. as the ultimate parent company including its subsidiaries, associates and joint ventures, the joint venture and a non‐consolidated subsidiary of Biotest AG, Biotest‐Vorsorge Trust e.V., as well as the members of the Board of Management and the Supervisory Board and persons related to them, as well as shareholders with a significant influence on Biotest AG.
With purchase agreements dated 2 May 2023 and 1 June 2023, five Biotest companies were sold to the respective local Grifols subsidiaries. The sold companies were also considered related parties since then, but four companies were merged with the respective local Grifols subsidary in the first quarter of 2024, and one company was liquidated at the end of 2024.
Unless explicitly stated otherwise, all outstanding balances are unsecured and will be settled in cash.
A) LOAN AGREEMENTS AND GUARANTEES
On 15 March 2024, the existing subordinated shareholder loan with Grifols Biotest Holdings GmbH was extended to 2 January 2030. At the same time, the lender agreed to a subordination in the loan agreement. As of 31 December 2024, the shareholder loan amounted to € 290.0 million (previous year: € 290.0 million) plus unpaid interest of € 46.6 million (previous year: € 39.5 million).
In the 2024 financial year, external financing from 2019 with a volume of € 240 million was repaid in full by the beginning of August. To cover the financing requirements, Biotest AG and Grifols Worldwide Operations Limited, Dublin, Ireland, a wholly owned subsidiary of Grifols, S.A., already concluded an agreement on 7 March 2023 for financing in the amount of € 147 million, which was fully utilised in 2024. This also included a specific subordination to the external lenders, which expired upon full repayment. At the end of 2024, the loan agreement was amended and the term extended until 31 December 2026. The interest accrued in 2024 amounted to € 4.6 million.
In October 2024, Grifols Worldwide Operations granted Biotest a further shareholder loan of € 50.3 million, which runs until 31 December 2026. The accrued interest in 2024 was € 1.1 million.
With the renewed letter of comfort dated 20 December 2024, Grifols S.A. undertakes to provide Biotest with sufficient liquidity and capital so that it is always in a position to meet its current and all future payment obligations to all creditors and will not become insolvent or over‐indebted. It is limited until 31 December 2026.
In the 2024 financial year, as part of a contractual trust arrangement (CTA), a trustee, Biotest‐Vorsorge Trust e.V., holds assets of € 8.1 million (previous year: € 7.9 million) for the external insolvency insurance of parts of the company pension scheme (see E 13).
Guarantees granted to two of the Biotest subsidiaries sold in the previous year amounted to a total of € 2.4 million, which expired in 2024 as a result of mergers with the respective Grifols subsidiaries acquired. As of 31 December 2024, there were no guarantees granted or received.
B) STRATEGIC COLLABORATION WITH GRIFOLS S.A.
On 31 May 2023, Biotest signed a technology transfer and licensing agreement with Grifols, S.A., Barcelona, Spain, with effect from 1 January 2023. The technology transfer and licensing agreement ensures that Biotest's new product developments (Yimmugo®, Fibrinogen, and Trimodulin) can be manufactured and marketed worldwide by making recourse to Grifols' organisation and production network. According to the agreement, Biotest is to disclose a total of six technology components and provide development services for certain products. A standard market transaction price was determined for the services agreed in the contract with the help of a valuation report using capital‐value‐oriented methods, which consists of both fixed and variable payments. Biotest receives fixed one‐off payments for the disclosure of the technology and for the provision of development results as well as the further implementation of development services. A licensing agreement was also concluded, which entails a revenue‐ based licence payment to Biotest following successful approval of the new products. The total revenue from technology disclosure and development services with Grifols, S.A. (whereby the aforementioned development services are also agreed in this contract), amounted to € 123.1 million in the 2024 financial year (previous year: € 190.1 million). The EBIT effect from the technology transfer and licensing agreement amounted to €89.3 million (previous year: € 158.2 million), of which € 84.3 million (previous year: € 153.5 million) was attributable to technology disclosure and € 5.0 million (previous year: € 4.7 million) to development services.
A master distribution agreement with separate individual contracts relating to the distribution of pharmaceutical plasma products in Italy, Nordic, Portugal, Singapore, Spain, Brazil, France, and the Great Britain wassigned with Grifols, S.A., in 2023. Where business transactions have arisen from the aforementioned contracts, the corresponding information is provided in the section about commercial transactions.
With effect from 1 January 2024, a new framework agreement (Amended and Restated Master Services Agreement) was concluded for the provision of services by Biotest in connection with the products licensed and technology packages disclosed to Grifols, S.A. The individual services are agreed in separate statements of work (SOW). The total expense in the 2024 financial year is € 9.4 million, of which € 5.1 million was outstanding as of 31 December 2024.
As part of itsfinal audits, Grifols, S.A. also hasreporting duties on the Biotest level, including mandatory SOX controls. A cost coverage agreement was concluded on 27 October 2022 for the associated personnel and financial commitment on the part of Biotest. In 2024, for the first time, corresponding services were rendered for the 2023 and 2024 financial years. The invoiced expenses amounted to € 1.4 million. Of this amount, € 1.2 million was outstanding as of 31 December 2024.
In a letter dated 18 January 2023, Grifols, S.A. agreed to reimburse Biotest for administrative costs, application fees and other expenses related to the application to the FDA for approval of the use of US blood plasma to manufacture Fibrinogen for the US market at the production site in Dreieich. In addition, Grifols has agreed to cover the costs of modifications to the production facility in order to obtain approval from the FDA, up to an amount of € 10 million. Costs of € 4.6 million were incurred for the first time in 2024. Of this, € 1.3 million was outstanding as of 31 December 2024.
C) COMMERCIAL TRANSACTIONS AND SERVICES
Transactions with related companies took place in the ordinary course of business. These business relationships were as follows:
| Revenues | Trade receivables/ Contract Expenses assets |
Trade liabilitites | ||||||
|---|---|---|---|---|---|---|---|---|
| in € million | 2024 | 2023 | 2024 | 2023 | 31.12.2024 | 31.12.2023 31.12.2024 | 31.12.2023 | |
| Grifols subsidiaries | 110.1 | 38.0 | – | 2.8 | 12.4 | 10.9 | – | 1.0 |
| Joint venture | 6.6 | 4.9 | – | – | 9.0 | 6.4 | – | 0.1 |
The majority of the revenues with Grifols' subsidiaries result from individual agreements in connection with the Master Distribution Agreement concluded with Grifols, S.A. for the distribution of pharmaceutical plasma products. In the previous year, revenues and expenses mainly related to transactions with the five sold Biotest companies.
The revenues with the Joint Venture result from toll manufacturing, in this course contract assets are also accounted for. In the 2024 financial year, impairment losses of € 0.1 million (previous year: € 0.0 million) were recognised on receivables from joint ventures.
D) SWAP AGREEMENT
An agreement has been in place with Grifols Worldwide Operations Limited since 2022 for the exchange ofsource plasma that differs in terms of origin. The agreement will remain in effect until 9 September 2025. In the 2024 financial year, 128,681 litres (previous year: 198,166 litres) of source plasma were supplied by Grifols to Biotest. In return, Biotest supplied 210,087 litres (prev. year: 196,396 litres) of source plasma to Grifols. As of 31 December 2024, liabilities to Grifols Worldwide Operations Limited under the plasma swap agreement amounted to € 0.0 million (previous year: € 7.0 million) and receivables amounted to € 3.7 million (previous year: € 0.0 million).
E) SUPERVISORY BOARD AND BOARD OF MANAGEMENT
Composition of the bodies
As at 31 December 2024, the members of the Supervisory Board and the Board of Management continue to hold the following mandates on statutory supervisory boards and comparable supervisory bodies of commercial enterprises:
Supervisory Board
Dr. Bernhard Ehmer, Heidelberg, Germany Chairman of the Supervisory Board of Biotest AG Member of the Supervisory Board of Affimed N.V., Mannheim, Germany Member of the Board of Achilles Therapeutics plc, London, UK
Jürgen Heilmann, Dreieich, Germany Commercial employee of Biotest AG, Dreieich, Germany Employee representative on the Supervisory Board of Biotest AG
Dirk Schuck, Rüsselsheim, Germany Diplom‐Betriebswirt (FH), M.A., employee of Biotest AG, Dreieich, Germany Employee representative on the Supervisory Board of Biotest AG
David Bell, Aledo, Texas, USA Member of the Supervisory Board of Biotest AG Chief Corporate Affairs & Legal Officer of Grifols, S.A., Barcelona, Spain Member of the Management Team of Grifols, S.A., Barcelona, Spain Member of several administrative bodies of the Grifols Group
Uta Kemmerich‐Keil, Darmstadt, Germany Member of the Supervisory Board of Biotest AG (member until 30 September 2024) Member of the Supervisory Board of Schott AG, Mainz, Germany Member of the Supervisory Board of Affimed N.V., Mannheim, Germany Member of the Supervisory Board of Karo Healthcare Actiebolag, Stockholm, Sweden Member of the Board of Directors of Klosterfrau Zürich AG, Zürich, Switzerland Member of the Advisory Board of Röchling SE & Co. KG, Mannheim, Germany Member of the Supervisory Board of Beiersdorf AG, Hamburg, Germany
Raimon Grifols Roura,
Sant Cugat del Vallès, Spain Member of the Supervisory Board of Biotest AG Co‐CEO and Deputy Chairman of the Administrative Board of Grifols, S.A., Barcelona, Spain Member of several administrative bodies of the Grifols Group
Prof. Dr. Gernot Hebestreit,
Leverkusen, Germany
Member of the Supervisory Board (since 28 November 2024) and Chairman of the Audit Committee of Biotest AG (since 9 December 2024)
Member of the Supervisory Board of PVA TePla AG, Wettenberg, Germany
Remuneration of the Supervisory Board
In the financial year under review, the Supervisory Board received a total of € 354 thousand (previous year: € 362 thousand), all of which comprises fixed remuneration components.
In addition to the Supervisory Board remuneration listed, further benefits were expensed in 2024 and 2023 financial years for employee representatives as part of their employment contracts. The amount of the remuneration is based on the provisions of the collective bargaining agreement or the salary levels applicable in the company for non‐pay‐scale employees.
A detailed description of the remuneration of the Supervisory Board as well as individualised figures can be found in the Remuneration Report of Biotest AG. This is available on the company's website.
Board of Management
Peter Janssen, Frankfurt am Main, Germany Member of the Board of Management (Chief Executive Officer from 1 January 2024, Chief Operations Officer until 31 December 2023)
Martin Möller, Bensheim, Germany Member of the Board of Management (Chief Financial Officer, member from 14 September 2024 to 15 March 2025)
Ainhoa Mendizabal Zubiaga, Sant Andreu de Llavaneres, Spain Member of the Board of Management (Chief Financial Officer, member until 13 September 2024)
Dr. Jörg Schüttrumpf, Frankfurt am Main, Germany Member of the Board of Management (Chief Scientific Officer, member until 31 August 2024)
Remuneration of the Board of Management
The total remuneration of the Board of Management active in the 2024 financial year amounted to € 3,449 thousand (previous year: € 4,540 thousand).
Short‐term benefits totalled € 3,015 thousand in the 2024 financial year (previous year: € 2,459 thousand). The short‐term Board of Management remuneration is divided into a non‐performance‐based component of € 2,440 thousand (previous year: € 1,807 thousand) and a performance‐based component of € 575 thousand (previous year: € 652 thousand).
The pension expense for post‐employment benefits in the financial year 2024 was € 275 thousand (previous year: € 730 thousand). Provisions of € 17,715 thousand (previous year: € 7,582 thousand) have been formed for pension commitments to former Board of Management members and theirsurviving dependants. As of the reporting date, no loan receivables from members of the executive bodies existed. Pension payments of € 824 thousand (previous year: € 520 thousand) were made to former members of the Board of Management in the 2024 financial year. No other one‐time or recurring commitments exist with the exception of the aforementioned pension commitments in the event of regular and early termination of Board of Management membership.
Other long‐term benefits totalled € 159 thousand in the 2024 financial year (previous year: € 1,351 thousand).
The participation of the members of the Board of Management in the long‐term incentive programme is presented by measuring the individual tranches for each financial year at their expected settlement amount.
Board of Management members participate in the non‐share‐based LTIP 2024 programme based on a fixed amount for 100 % target achievement granted first‐time in the 2024 financial year. This amounts to € 210 thousand for Dr. Schüttrumpf, € 428 thousand for Mr. Janssen, and € 300 thousand for Ms. Mendizabal Zubiaga. A provision of € 36 thousand was formed for this tranche in 2024. Of this amount, € 0 thousand is attributable to Dr. Schüttrumpf, € 36 thousand to Mr. Janssen, and € 0 thousand to Ms. Mendizabal Zubiaga. Due to the departure of Dr. Schüttrumpf and Ms. Mendizabal Zubiaga, no provisions for the LTIP 2024 were recognised for either of these individuals as of the year‐end. Mr. Möller did not receive an LTIP commitment for his aforementioned period of service.
Board of Management members participate in the non‐share‐based LTIP 2023 programme based on a fixed amount for 100 % target achievement. This amounts to € 210 thousand for Dr. Schüttrumpf, € 300 thousand for Mr. Janssen, and € 220 thousand for Ms. Mendizabal Zubiaga. A provision of € 110 thousand was formed for this tranche in 2024 (previous year: € 186 thousand). Of this amount, € 0 thousand (previous year: € 34 thousand) is attributable to Dr. Schüttrumpf, € 45 thousand (previous year: € 48 thousand) to Mr. Janssen, and € 0 thousand (previous year: € 35 thousand) to Ms. Mendizabal Zubiaga. Due to the departure of Dr. Schüttrumpf and Ms. Mendizabal Zubiaga, no provisions were made for either of them at the end of the year for the LTIP 2023. The remaining provision refers to former Board of Management members.
Board of Management members participate in the non‐share‐based LTIP 2022 programme based on a fixed amount for 100 % target achievement. This amounts to € 210 thousand for Dr. Schüttrumpf, and to € 273 thousand for Mr. Janssen. A provision of € 305 thousand was formed for this tranche in 2024 (previous year: € 541 thousand). Of this amount, € 0 thousand (previous year: € 88 thousand) is attributable to Dr. Schüttrumpf, and € 77 thousand (previous year: € 114 thousand) to Mr. Janssen. Due to the departure of Dr. Schüttrumpf, no provision was recognised for him for the LTIP 2022 as of the year‐end. The remaining provision refers to former Board of Management members.
Board of Management members participate in the non‐share‐based LTIP 2021 programme based on a fixed amount for 100 % target achievement. This amounts to € 90 thousand for Dr. Schüttrumpf. A provision of € 1,017 thousand (previous year: € 626 thousand) was formed for this tranche in 2024. Of this amount, € 0 thousand (previous year: € 63 thousand) is attributable to Dr. Schüttrumpf. Due to the departure of Dr. Schüttrumpf, no provision wasrecognised for him for the LTIP 2021 as of the year‐end. The total provision refers only to former Board of Management members.
Termination benefits in the financial year 2024 amounted to € 1,050 thousand (previous year: € 0 thousand).
The employment contracts include market‐standard severance provisions in the event of a change of ownership or control, as well as in the event of early termination of employment at the instigation of Biotest AG. Both types of severance payments are limited to twice the annual remuneration, whereby, in the case of early termination of an employment relationship, an additional cap applies due to the expected remuneration up to the regular end of the employment period plus company car compensation.
Severance payment claims are ruled out in the event of termination of the employment contract on good grounds, illness or incapacity to work, or if the Board of Management member receives benefits or advantages in value from third parties in connection with a change of ownership or control. Similarly, no severance payment claims exist in the event that a service contract isterminated early at the instigation of the respective Board of Management member.
A detailed description of the remuneration scheme for the Board of Management as well as individualised figures are presented in the Remuneration Report of Biotest AG. This is available on the Biotest website.
F 9 LIST OF SHAREHOLDINGS
The companies that form part of the shareholdings of Biotest AG pursuant to Section 313 (2) of the German Commercial Code (HGB) through a direct or indirect interest are listed below. All figures were determined for the purposes of the consolidated financial statements in accordance with IFRS regulations.
| Name of the Company | Seat of company | Equity in € million |
Share in the capital in % |
Results after taxes in € million 0.0 |
|
|---|---|---|---|---|---|
| Biotest Pharma GmbH ** | Dreieich, Germany | 129.8 | 100.0 | ||
| Biotest Grundstücksverwaltungs GmbH /** | Dreieich, Germany | 10.1 | 100.0 | 0.0 | |
| Plasma Service Europe GmbH /** | Dreieich, Germany | 55.5 | 100.0 | 0.0 | |
| Biotest‐Vorsorge‐Trust e.V.** | Dreieich, Germany | 0.0 | 0.0 | 0.0 | |
| Biotest Austria GmbH | Vienna, Austria | 2.5 | 100.0 | 0.5 | |
| Biotest (Schweiz) AG | Rupperswil, Switzerland | 5.0 | 100.0 | 0.8 | |
| Biotest Hungaria Kft. | Budapest, Hungary | 4.0 | 100.0 | 0.4 | |
| Biotest Hellas MEPE | Athens, Greece | –7.9 | 100.0 | 0.0 | |
| Biotest Lux S.à.r.l. * | Luxemburg, Luxemburg | 0.2 | 100.0 | 0.5 | |
| Plazmaszolgálat Kft. * | Budapest, Hungary | 5.4 | 100.0 | 0.0 | |
| Cara Plasma s.r.o. * | Prague, Czech Republic | 0.1 | 100.0 | ‐2.9 | |
| Cara Plasma SK s.r.o. / *** | Bratislava; Slovakia | 0.0 | 100.0 | 0.0 | |
| BioDarou P.J.S. Company /*/*** | Tehran, Iran | 3.7 | 49.0 | –4.4 | |
| Biotest Pharmaceuticals ILAÇ Pazarlama Anonim Sirketi */** |
Istanbul, Turkey | 0.0 | 100.0 | 0.0 |
* Indirect interest
** After assumption of HGB result by Biotest AG
*** After assumption of HGB result by Biotest Pharma GmbH
**** The non‐consolidated company is not included in the consolidated financial statements for reasons of materiality.
***** Information as of 31 December 2023
****** Excluding an adjustment due to IAS 29
******* New foundation in 2023
******** Trustee asset management
F 10 EXEMPTION OPTION ACCORDING TO SECTION 264 (3) HGB
For the annual financial statements of Biotest Pharma GmbH, Plasma Service Europe GmbH, and Biotest Grundstücksverwaltungs GmbH, all located at Dreieich, Germany, the exemption option pursuant to Section 264 (3) of the German Commercial Code (HGB) is utilised for the 2024 financial year to the extent that no notes to financial statements are prepared for all three companies and no management report is prepared for the separate companies Biotest Pharma GmbH and Plasma Service Europe GmbH. In addition, all three companies' annual financial statements are not published.
F 11 PENDING AND IMMINENT LEGAL PROCEEDINGS
Provisions amounting to €0.1 million (previous year: €0.1 million) were recognized for pending and imminent legal proceedings as of the balance sheet date. The provision for litigation risks mainly comprises the expected legal fees in connection with ongoing antitrust proceedings against the Romanian authorities. In addition, potential risks related to cases of workplace bullying and unfair dismissal claims are also taken into account.
F 12 EVENTS AFTER THE REPORTING DATE
The Supervisory Board announced at its meeting on 5 March 2025, that Chief Financial Officer Martin Möller will end his tenure as CFO as planned upon expiration of his contract on 15 March 2025.
On 25 March 2025 Biotest agreed with Grifols World Wide Operations Limited, Dublin, Ireland, to increase the shareholder loan in the amount of € 49.7 million. The payment is scheduled for the beginning of April 2025.
No further events materially affecting the net assets, financial position or results of operations occurred after the balance sheet date.
F 13 CORPORATE GOVERNANCE
The Board of Management and the Supervisory Board of Biotest AG have issued the Declaration of Conformity required by Section 161 of the German Stock Corporation Act (AktG) and made it permanently available to the shareholders on the company's website.
Dreieich, 24 March 2025
Peter Janssen Chairman of the Board of Management
DECLARATION OF THE LEGAL REPRESENTATIVES IN ACCORDANCE WITH SECTION 117 NO. 1 OF THE GERMAN SECURITIES TRADING ACT (WPHG) IN CONJUNCTION WITH SECTION 297 (2) SENTENCE 4 AND SECTION 315 (1) SENTENCE 5 OF THE GERMAN COMMERCIAL CODE (HGB)
"To the best of our knowledge, and in accordance with the applicable reporting principles, the consolidated financialstatements give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group, and the Group management report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the principal opportunities and risks associated with the expected development of the Group."
Dreieich, 24 March 2024
Biotest Aktiengesellschaft
The Board of Management
Peter Janssen Chairman of the Board of Management
INDEPENDENT AUDITOR'S REPORT
To Biotest Aktiengesellschaft, Dreieich/Germany
REPORT ON THE AUDIT OF THE CONSOLIDATED FINANCIAL STATEMENTS AND OF THE COMBINED MANAGEMENT REPORT
Audit Opinions
We have audited the consolidated financial statements of Biotest Aktiengesellschaft Dreieich/Germany, and its subsidiaries (the Group), which comprise the consolidated statement of financial position as at 31 December 2024, the consolidated statement of income, the consolidated statement of comprehensive income, the consolidated statement of changes in equity and the consolidated statement of cash flows for the financial year from 1 January to 31 December 2024, and the notes to the consolidated financial statements, including material accounting policy information. In addition, we have audited the combined management report for the Parent and the Group of Biotest AG, Dreieich/Germany, for the financial year from 1 January to 31 December 2024. In accordance with the German legal requirements, we have not audited the content of the combined non‐financial statement in accordance with Sections 289b to 289e, 315b and 315c German Commercial Code (HGB) included in section F of the combined management report and the group corporate governance statement in accordance with Sections 289f and 315d HGB included in section E of the combined management report. In addition, we have not audited the content of the disclosures in the combined management report that are marked as unaudited.
In our opinion, on the basis of the knowledge obtained in the audit:
- the accompanying consolidated financialstatements comply, in all material respects, with the IFRS® Accounting Standardsissued by the International Accounting Standards Board (IASB) (hereinafter "IFRS Accounting Standards") as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB and, in compliance with these requirements, give a true and fair view of the assets, liabilities and financial position of the Group as at 31 December 2024 and of its financial performance for the financial year from 1 January to 31 December 2024, and
- the accompanying combined management report as a whole provides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Our audit opinion on the combined management report does not cover the content of the statementsreferred to above and of the unaudited disclosures.
Pursuant to Section 322 (3)sentence 1 HGB, we declare that our audit has not led to any reservationsrelating to the legal compliance of the consolidated financial statements and of the combined management report.
Basis for the Audit Opinions
We conducted our audit of the consolidated financial statements and of the combined management report in accordance with Section 317 HGB and the EU Audit Regulation (No. 537/2014; referred to subsequently as "EU Audit Regulation") and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report" section of our auditor's report. We are independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2) point (f) of the EU Audit Regulation, we declare that we have not provided non‐audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinions on the consolidated financial statements and on the combined management report.
Key Audit Matters in the Audit of the Consolidated Financial Statements
Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the consolidated financial statements for the financial year from 1 January to 31 December 2024. These matters were addressed in the context of our audit of the consolidated financial statements as a whole and in forming our audit opinion thereon; we do not provide a separate audit opinion on these matters.
In the following, we present the key audit matters we have determined in the course of our audit:
-
- recoverability of trade receivables from customers in Iran
-
- revenue recognition and existence of arm's length conditions relating to the technology transfer licensing agreement concluded with Grifols, S.A.
Our presentation of these key audit matters has been structured as follows:
- a) description (including reference to corresponding information in the consolidated financial statements)
- b) auditor's response
Recoverability of trade receivables from customers in Iran
a) Biotest AG maintains business relationships with customers in Iran, which resulted in outstanding receivables – after deduction of valuation allowances of mEUR 4.2 (prior year: mEUR 1.7) – in the amount of mEUR 38.1 as at the reporting date of 31 December 2024 (prior year: mEUR 8.9).
Some of the business relationships with customers in Iran are characterised by longer payment terms and more difficult conditions due to international sanctions imposed on Iran, as well as the transfer of foreign currency. The executive directors account for these special factors by recognising a global valuation allowance of 30% of the nominal amount after one year for overdue receivables from customersin Iran, which then increases each month on a straightline basis up to a valuation allowance of 100% after three years.
Due to their size, the trade receivables from customers in Iran have a significant impact on the Group's assets and liabilities, financial position and financial performance. Given the length of the payment terms and the payment behaviour, as well as existing foreign exchange restrictions, the determination of valuation allowances requires judgement. There is therefore a risk that impairment risks are not sufficiently taken into account and that the recognised valuation allowances may be too low. For these reasons, we have classified the trade receivables from customers in Iran as a key audit matter.
For information on the recognition and measurement policies applied, as well as the outstanding receivables and recognised valuation allowances, please refer to sections B 12 and F.III. of the notes to the financial statements, respectively.
For information on the risks identified by the executive directors in connection with receivables from customers in Iran, please also refer to the combined management report, section D. II. 6 Risk assessment and description of significant risk categories.
b) As part of our audit, we first gained an overview of the processes and accounting‐related controls with regard to the creation of master data, the allocation of credit limits and the recognition and management of valuation allowances. We evaluated the design of identified controls relevant to the audit and verified that they had been implemented. In the case of estimates made by the executive directors, we evaluated the reasonableness of the methods applied, the assumptions made and the data used.
On the basis of a mathematical‐statistical sample, we requested external balance confirmations from the customers. We used these confirmations as well as alternative audit procedures to satisfy ourselves of the existence and amount of the receivables.
Based on discussions with the executive directors, the head of the finance department and accounting clerks in the accounts receivable department named by them, we gained a detailed overview of the existing customers in Iran, inspected and assessed their past payment behaviour and the payment defaults of the past five years, and satisfied ourselves of the procedure for determining any necessary valuation allowances and their review by the executive directors over time. In doing so, we also
obtained the executive directors' evaluation of the current and estimated future payment behaviour of the customers in Iran and assessed this evaluation. In this context, our focus was on receivables that were already overdue as at the reporting date under the agreed payment terms. As part of our audit procedures with regard to events after the reporting date, we examined whether any adjusting events that occurred up to the date of the auditor's report were appropriately taken into account.
We verified that the relevant information in the notes to the financial statements was complete and accurate.
Revenue recognition and existence of arm's length conditions of the technology transfer licensing agreement (TTLA) concluded with Grifols, S.A.
a) On 31 May 2023, the majority shareholder Grifols, S.A., Barcelona/Spain, and Biotest AG concluded a technology transfer and licensing agreement (TTLA). According to the consolidated financial statements, revenue under the TTLA totalled mEUR 123.1 in the financial year 2024 (prior year: mEUR 190.1). The TTLA's contribution to EBIT amounted to mEUR 89.3 in the financial year 2024 (prior year: mEUR 158.2).
The primary subject matter of this multi‐component agreement is the disclosure of six autonomously usable technologies of the new "Biotest Next Level" production plant to Grifols, S.A. by Biotest for a total amount of mEUR 237.6 and the disclosure of related future improvements for mEUR 2.4, as well as the provision of the development results for the product Yimmugo, which is already on the market, and the products Fibrinogen and Trimodulin, which are still in the marketing authorisation and development phase, respectively, for a total amount of mEUR 220.0. Biotest will receive revenue‐based licence payments from Grifols, S.A. resulting from the subsequent sale and worldwide marketing of the three new products. The agreement is based on a valuation report by an external expert. This report is intended to substantiate the payments to be made by Grifols, S.A. to Biotest using capital value‐oriented valuation methods and the fact that the agreement was concluded on an arm's length basis.
The six technologies were disclosed in 2023 (four technologies) and 2024 (two technologies). The portions of the agreed total revenue of mEUR 237.6 attributable to the disclosure of the individual technologies were recognised as revenue at the time of the respective disclosure. Revenue from the provision of the development results is billed with a profit markup on the expenses incurred for each project after the respective services have been provided. In the past two years, some development services provided have already been billed, and further billing will follow in accordance with the agreement during the further development period.
The contractual agreement determined the total prices of the technologies to be disclosed (mEUR 237.6) and the development services to be provided (mEUR 220.0), but not individual tranches.
The executive directors have to decide whether the disclosed technologies comply with the criteria for revenue‐related performance obligations in accordance with IFRS 15. It therefore has to be assessed, among other things, whether the disclosed technologies can be used individually by Grifols, S.A. and whether the research and development results can provide Grifols, S.A. with a benefit of its own. When determining the price and allocating the consideration to the individual performance obligations, the executive directors make assumptions, such as the yield from the substances, the capital expenditure incurred, the cost of capital and the plasma allocation key. In addition, these transactions are significant transactions of exceptional size between related parties. The executive directors' statement on the arm's length nature of the components of the TTLA therefore also requires judgement and, as a result, is particularly relevant for minority shareholders.
For these reasons, this matter was of particular relevance to us.
For information on the recognition and measurement policies relating to the TTLA, please refer to note B 13 to the financial statements.
b) As part of our audit, we first gained an understanding of the processes and procedures for defining the date of performance and the approval process for material transactions of exceptional size. We evaluated the design of identified controls relevant to the audit and verified that they had been implemented. We focused on our tests of details regarding proper revenue recognition in accordance with IFRS 15; for this purpose, we inspected the contractual and other relevant documents and assessed, with the involvement of our specialists for IFRS Accounting Standards, whether a contract with a customer in accordance with IFRS 15 exists, the individual performance obligations were classified in accordance with the criteria for IFRS 15, the individual usability of the transactions was assessed appropriately and the revenue wasrecognised in line with the transfer of the power of disposal. With the help of our internal valuation experts, we examined the statement on the arm's length nature of the performance obligations defined in the agreement, reviewed the allocation of the agreed payments to the individual performance obligations and critically analysed the recognition of revenue when the performance obligations were fulfilled. Taking into account our evaluation of the competence, capabilities and objectivity of the expert engaged by the executive directors, we used the results of the expert within the scope of our audit. We assessed whether the measurement policies used complied with IFRS valuation principles.
In addition, we evaluated the occurrence, accuracy and cut‐off of revenue from individual bookings based on the TTLA in the financial year 2024, which were selected using a mathematical‐statistical procedure, by inspecting relevant documents such as invoices, performance records and payment records, and comparing them with the contractual basis and assessing them.
We assessed the information on the TTLA in the notes to the financial statements in terms of the amount and scope of the transactions, the arm's length nature and the future effects of the contractual agreement.
Other Information
The executive directors and/or the supervisory board are responsible for the other information. The other information comprises:
- the report of the supervisory board,
- the corporate governance statement,
- the combined non‐financial statement,
- the unaudited content of the combined management report marked as "unaudited",
- the executive directors' confirmations pursuant to Sections 297 (2) sentence 4 and 315 (1) sentence 5 HGB regarding the consolidated financial statements and the combined management report, and
- all other parts of the annual report,
- but not the consolidated financial statements, not the audited content of the disclosures in the combined management report and not our auditor's report thereon.
The supervisory board is responsible for the report of the supervisory board. The executive directors and the supervisory board are responsible for the statement according to Section 161 German Stock Corporation Act (AktG) concerning the German Corporate Governance Code, which is part of the corporate governance statement. Otherwise the executive directors are responsible for the other information.
Our audit opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an audit opinion or any other form of assurance conclusion thereon.
In connection with our audit, our responsibility isto read the other information identified above and, in doing so, to consider whether the other information:
- is materially inconsistent with the consolidated financialstatements, with the audited content of the disclosuresin the combined management report or our knowledge obtained in the audit, or
- otherwise appears to be materially misstated.
Responsibilities of the Executive Directors and the Supervisory Board for the Consolidated Financial Statements and the Combined Management Report
The executive directors are responsible for the preparation of the consolidated financial statements that comply, in all material respects, with IFRS Accounting Standards as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB, and that the consolidated financial statements, in compliance with these requirements, give a true and fair view of the assets, liabilities, financial position and financial performance of the Group. In addition, the executive directors are
responsible for such internal control as they have determined necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud (i.e. fraudulent financial reporting and misappropriation of assets) or error.
In preparing the consolidated financial statements, the executive directors are responsible for assessing the Group's ability to continue as a going concern. They also have the responsibility for disclosing, as applicable, matters related to going concern. In addition, they are responsible for financial reporting based on the going concern basis of accounting unless there is an intention to liquidate the Group or to cease operations, or there is no realistic alternative but to do so.
Furthermore, the executive directors are responsible for the preparation of the combined management report that as a whole provides an appropriate view of the Group's position and is, in all material respects, consistent with the consolidated financial statements, complies with German legal requirements, and appropriately presents the opportunities and risks of future development. In addition, the executive directors are responsible for such arrangements and measures (systems) as they have considered necessary to enable the preparation of a combined management report that isin accordance with the applicable German legal requirements, and to be able to provide sufficient appropriate evidence for the assertionsin the combined management report.
The supervisory board is responsible for overseeing the Group's financial reporting process for the preparation of the consolidated financial statements and of the combined management report.
Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report
Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and whether the combined management report as a whole provides an appropriate view of the Group's position and, in all material respects, is consistent with the consolidated financial statements and the knowledge obtained in the audit, complies with the German legal requirements and appropriately presents the opportunities and risks of future development, as well as to issue an auditor's report that includes our audit opinions on the consolidated financial statements and on the combined management report.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this combined management report.
We exercise professional judgement and maintain professional scepticism throughout the audit. We also:
- identify and assessthe risks of material misstatement ofthe consolidated financialstatements and ofthe combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our audit opinions. The risk of not detecting a material misstatement resulting from fraud is higher than the risk of not detecting a material misstatement resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.
- obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measuresrelevant to the audit ofthe combined managementreport in orderto design audit proceduresthat are appropriate in the circumstances, but not for the purpose of expressing an audit opinion on the effectiveness of internal control or these arrangements and measures of the Group.
- evaluate the appropriateness of accounting policies used by the executive directors and the reasonableness of estimates made by the executive directors and related disclosures.
- conclude on the appropriateness of the executive directors' use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the
Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in the auditor's report to the related disclosures in the consolidated financial statements and in the combined management report or, if such disclosures are inadequate, to modify our respective audit opinions. Our conclusions are based on the audit evidence obtained up to the date of our auditor'sreport. However, future events or conditions may cause the Group to cease to be able to continue as a going concern.
- evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financialstatements present the underlying transactions and eventsin a manner that the consolidated financial statements give a true and fair view of the assets, liabilities, financial position and financial performance of the Group in compliance with IFRS Accounting Standards as adopted by the EU and with the additional requirements of German commercial law pursuant to Section 315e (1) HGB.
- plan and perform the audit of the consolidated financial statements in order to obtain sufficient appropriate audit evidence regarding the financial information of the entities or of the business activities within the Group, which serves as a basis for forming audit opinions on the consolidated financial statements and on the combined management report. We are responsible for the direction, supervision and inspection of the audit procedures performed for the purposes of the group audit. We remain solely responsible for our audit opinions.
- evaluate the consistency of the combined management report with the consolidated financial statements, its conformity with German law, and the view of the Group's position it provides.
- perform audit procedures on the prospective information presented by the executive directors in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, the significant assumptions used by the executive directors as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate audit opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information.
We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.
We provide those charged with governance with a statement that we have complied with the relevant independence requirements, and communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the actions taken or safeguards applied to eliminate independence threats.
From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consolidated financial statements for the current period and are therefore the key audit matters. We describe these matters in the auditor's report unless law or regulation precludes public disclosure about the matter.
OTHER LEGAL AND REGULATORY REQUIREMENTS
Report on the Audit of the Electronic Reproductions of the Consolidated Financial Statements and of the Combined Management Report Prepared for Publication Pursuant to Section 317 (3a) HGB
Audit Opinion
We have performed an audit in accordance with Section 317 (3a) HGB to obtain reasonable assurance whether the electronic reproductions of the consolidated financial statements and of the combined management report (hereinafter referred to as "ESEF documents") prepared for publication, contained in the file, which has the SHA‐256 value 6a6eefc461115f80d3251458c9aa3340cc60b6438c5d8b259d0efc4208c8f9bc, meet, in all material respects, the requirementsfor the electronic reporting format pursuant to Section 328 (1) HGB ("ESEF format"). In accordance with the German legal requirements, this audit only covers the conversion of the information contained in the consolidated financial statements and the combined management report into the ESEF format, and therefore covers neither the information contained in these electronic reproductions nor any other information contained in the file identified above.
In our opinion, the electronic reproductions of the consolidated financial statements and of the combined management report prepared for publication contained in the file identified above meet, in all material respects, the requirements for the electronic reporting format pursuant to Section 328 (1) HGB. Beyond this audit opinion and our audit opinions on the accompanying consolidated financial statements and on the accompanying combined management report for the financial year from 1 January to 31 December 2024 contained in the "Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report" above, we do not express any assurance opinion on the information contained within these electronic reproductions or on any other information contained in the file identified above.
Basis for the Audit Opinion
We conducted our audit of the electronic reproductions of the consolidated financial statements and of the combined management report contained in the file identified above in accordance with Section 317 (3a) HGB and on the basis of the IDW Auditing Standard: Audit of the Electronic Reproductions of Financial Statements and Management Reports Prepared for Publication Purposes Pursuant to Section 317 (3a) HGB (IDW AuS 410 (06.2022)). Our responsibilities in this context are further described in the "Group Auditor's Responsibilities for the Audit of the ESEF Documents" section. Our audit firm has applied the requirements of the IDW Quality Management Standards.
Responsibilities of the Executive Directors and the Supervisory Board for the ESEF Documents
The executive directors of the Parent are responsible for the preparation of the ESEF documents based on the electronic files of the consolidated financial statements and of the combined management report according to Section 328 (1) sentence 4 no. 1 HGB and for the tagging of the consolidated financial statements according to Section 328 (1) sentence 4 no. 2 HGB.
In addition, the executive directors of the Parent are responsible for such internal control that they have considered necessary to enable the preparation of ESEF documents that are free from material intentional or unintentional non‐compliance with the requirements for the electronic reporting format pursuant to Section 328 (1) HGB.
The supervisory board is responsible for overseeing the process for preparing the ESEF documents as part of the financial reporting process.
Group Auditor's Responsibilities for the Audit of the ESEF Documents
Our objective is to obtain reasonable assurance about whether the ESEF documents are free from material intentional or unintentional non‐compliance with the requirements of Section 328 (1) HGB. We exercise professional judgement and maintain professional scepticism throughout the audit. We also:
- identify and assess the risks of material intentional or unintentional non‐compliance with the requirements of Section 328 (1) HGB, design and perform audit proceduresresponsive to those risks, and obtain audit evidence that issufficient and appropriate to provide a basis for our audit opinion.
- obtain an understanding of internal control relevant to the audit on the ESEF documents in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an assurance opinion on the effectiveness of these controls.
- evaluate the technical validity of the ESEF documents, i.e. whether the file containing the ESEF documents meets the requirements of the Delegated Regulation (EU) 2019/815, in the version in force at the reporting date, on the technical specification for this electronic file.
- evaluate whether the ESEF documents enable an XHTML reproduction with content equivalent to the audited consolidated financial statements and to the audited combined management report.
• evaluate whether the tagging of the ESEF documents with Inline XBRL technology (iXBRL) in accordance with the requirements of Articles 4 and 6 of the Delegated Regulation (EU) 2019/815, in the version in force at the reporting date, enables an appropriate and complete machinereadable XBRL copy of the XHTML reproduction.
Further Information Pursuant to Article 10 of the EU Audit Regulation
We were elected as group auditor by the general meeting on 7 May 2024. We were engaged by the supervisory board on 23 and 26 September 2024. We have been the group auditor of Biotest AG, Dreieich/Germany, since the financial year 2024.
We declare that the audit opinions expressed in this auditor'sreport are consistent with the additional report to the audit committee pursuant to Article 11 of the EU Audit Regulation (long‐form audit report).
OTHER MATTER – USE OF THE AUDITOR'S REPORT
Our auditor's report must always be read together with the audited consolidated financial statements and the audited combined management report as well as with the audited ESEF documents. The consolidated financial statements and the combined management report converted into the ESEF format – including the versions to be submitted for inclusion in the Company Register – are merely electronic reproductions of the audited consolidated financial statements and the audited combined management report and do not take their place. In particular, the ESEF report and our audit opinion contained therein are to be used solely together with the audited ESEF documents made available in electronic form.
GERMAN PUBLIC AUDITOR RESPONSIBLE FOR THE ENGAGEMENT
The German Public Auditor responsible for the engagement is Dirk Hällmayr.
Frankfurt am Main/Germany, 28 March 2025
Deloitte GmbH
Wirtschaftsprüfungsgesellschaft
Signed: Signed: Dirk Hällmayr Marlene Müller Wirtschaftsprüfer Wirtschaftsprüfer (German Public Auditor) (German Public Auditor)
ASSURANCE REPORT OF THE INDEPENDENT GERMAN PUBLIC AUDITOR ON A LIMITED ASSURANCE ENGAGEMENT IN RELATION TO THE COMBINED NON‐FINANCIAL STATEMENT INCLUDED IN THE COMBINED MANAGEMENT REPORT
To Biotest AG, Dreieich/Germany
Assurance Conclusion
We have conducted a limited assurance engagement on the Combined Non‐Financial Statement of Biotest AG, Dreieich/Germany, combining the Consolidated Sustainability Statement and the Non‐Financial Statement of the Parent, included in section "Combined Non‐Financial Statement" of the combined management report for the Parent and the Group for complying with Sections 289b to 289e, 315b and 315c German Commercial Code (HGB) including the disclosures for complying with the requirements under Article 8 of Regulation (EU) 2020/852 included in this Combined Non‐Financial Statement, for the financial year from 1 January to 31 December 2024 (hereinafter referred to as "the Combined Non‐Financial Statement").
Not subject to our assurance engagement are:
• the prior year's disclosures marked as unassured.
Based on the procedures performed and the evidence obtained, nothing has come to our attention that causes us to believe that the accompanying Combined Non‐Financial Statement for the financial year from 1 January to 31 December 2024 is not prepared, in all materialrespects, in accordance with Sections 289b to 289e, 315b and 315c HGB and the requirements of Article 8 of Regulation (EU) 2020/852, and the specifying criteria presented by the executive directors of the Company.
We do not express an assurance conclusion on the parts of the Combined Non‐Financial Statement marked as unassured.
Basis for the Assurance Conclusion
We conducted our assurance engagement in accordance with the International Standard on Assurance Engagements (ISAE) 3000 (Revised): "Assurance Engagements Other Than Audits or Reviews of Historical Financial Information", issued by the International Auditing and Assurance Standards Board (IAASB).
The procedures performed in a limited assurance engagement vary in nature and timing from, and are less in extent than for, a reasonable assurance engagement. Consequently, the level of assurance obtained is substantially lower than the assurance that would have been obtained had a reasonable assurance engagement been performed.
Our responsibilities under ISAE 3000 (Revised) are further described in section "German Public Auditor's Responsibilities for the Assurance Engagement on the Combined Non‐Financial Statement".
We are independent of the entity in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. Our audit firm has applied the requirements of the IDW Quality Management Standards. We believe that the evidence we have obtained is sufficient and appropriate to provide a basis for our assurance conclusion.
Responsibilities of the Executive Directors and the Supervisory Board for the Combined Non‐Financial Statement
The executive directors are responsible for the preparation of the Combined Non‐Financial Statement in accordance with the applicable German legal and European requirements as well as with the specifying criteria presented by the executive directors of the Company and for designing, implementing and maintaining such internal control as they have considered necessary to enable the preparation of a combined non‐financial statement in accordance with these requirements that is free from material misstatement, whether due to fraud (i.e. fraudulent reporting in the Combined Non‐Financial Statement) or error.
This responsibility of the executive directors includes selecting and applying appropriate reporting policies for preparing the Combined Non‐Financial Statement as well as making assumptions and estimates and ascertaining forward‐looking information for individual sustainability‐related disclosures.
The supervisory board is responsible for overseeing the process for the preparation of the Combined Non‐Financial Statement.
Inherent Limitations in Preparing the Combined Non‐Financial Statement
The applicable German legal and European requirements contain wording and terms that are subject to considerable interpretation uncertainties and for which no authoritative comprehensive interpretations have yet been published. The executive directors have disclosed interpretations of such wording and terms in the Combined Non‐Financial Statement. The executive directors are responsible for the reasonableness of these interpretations. As such wording and terms may be interpreted differently by regulators or courts, the legality of measurements or evaluations of the sustainability matters based on these interpretations is uncertain. The quantification of non‐financial performance indicators disclosed in the Combined Non‐Financial Statement is also subject to inherent uncertainties.
These inherent limitations also affect the assurance engagement on the Combined Non‐Financial Statement.
German Public Auditor's Responsibilities for the Assurance Engagement on the Combined Non‐Financial Statement
Our objective is to express a limited assurance conclusion, based on the assurance engagement we have conducted, on whether any matters have come to our attention that cause us to believe that the Combined Non‐Financial Statement has not been prepared, in all material respects, in accordance with the applicable German legal and European requirements and the specifying criteria presented by the executive directors of the Company and to issue an assurance report that includes our assurance conclusion on the Combined Non‐Financial Statement.
As part of a limited assurance engagement in accordance with ISAE 3000 (Revised), we exercise professional judgement and maintain professional scepticism. We also:
obtain an understanding of the process used to prepare the Combined Non‐Financial Statement.
identify disclosures where a material misstatement due to fraud or error is likely to arise, design and perform procedures to address these disclosures and obtain limited assurance to support the assurance conclusion. The risk of not detecting a material misstatement resulting from fraud is higher than the risk of not detecting a material misstatement resulting from error, asfraud may involve collusion, forgery, intentional omissions, misrepresentations or the override of internal control.
consider the forward‐looking information, including the appropriateness of the underlying assumptions. There is a substantial unavoidable risk that future events will differ materially from the forward‐looking information.
Summary of the Procedures Performed by the German Public Auditor
A limited assurance engagement involves the performance of procedures to obtain evidence about the sustainability information. The nature, timing and extent of the selected procedures are subject to our professional judgement.
In performing our limited assurance engagement, we:
- evaluated the suitability of the criteria as a whole presented by the executive directors in the Combined Non‐Financial Statement.
- inquired of the executive directors and relevant employees involved in the preparation of the Combined Non‐Financial Statement about the preparation process and about the internal controls related to this process.
- evaluated the reporting policies used by the executive directors to prepare the Combined Non‐Financial Statement.
- evaluated the reasonableness of the estimates and related information provided by the executive directors.
- performed analytical procedures or tests of details and made inquiriesin relation to selected information in the Combined Non‐Financial Statement.
- conducted site visits.
- considered the presentation of the information in the Combined Non‐Financial Statement.
- considered the processfor identifying taxonomy‐eligible and taxonomy‐aligned economic activities and the corresponding disclosures in the Combined Non‐Financial Statement.
Restriction of Use
We issue this report as stipulated in the engagement letter agreed with the Company (including the "General Engagement Terms for Wirtschaftsprüferinnen, Wirtschaftsprüfer and Wirtschaftsprüfungsgesellschaften (German Public Auditors and Public Audit Firms)" dated 1 January 2024 of the Institut der Wirtschaftsprüfer (IDW)). We draw attention to the fact that the assurance engagement was conducted for the Company's purposes and that the report is intended solely to inform the Company about the result of the assurance engagement. Consequently, it may not be suitable for any otherthan the aforementioned purpose. Accordingly,the report is not intended to be used by third parties as a basis for making (financial) decisions.
Our responsibility is to the Company alone. We do not accept any responsibility to third parties. Our assurance conclusion is not modified in this respect.
Frankfurt am Main/Germany, 28 March 2025
Deloitte GmbH
Wirtschaftsprüfungsgesellschaft
Marlene Müller Manuel Beyer Wirtschaftsprüfer Wirtschaftsprüfer (German Public Auditor) (German Public Auditor)
SUPERVISORY BOARD REPORT
In the 2024 financial year, the Supervisory Board, in its function as a supervisory body and guided by the principles of responsible and good corporate governance, performed the duties incumbent upon it in accordance with the law, the Articles of Association and the Rules of Procedure without restriction. It regularly and carefully monitored the Board of Management's management of the Company and advised it on all matters of importance to the Company. The Board of Management also informed the Supervisory Board outside of meetings at regular intervals through written and verbal reports in a comprehensive and timely manner on current issues and all matters of fundamental importance to the Company, including decisions that did not require the approval of the Supervisory Board. In particular, the Board of Management regularly informed the Supervisory Board about key business figures and about issues relating to planning, business development, strategic development, personnel and succession planning, the risk situation, risk management and compliance. Where the course of business deviated from the plan, the Board of Management explained these deviations and always involved the Supervisory Board in the coordination of strategy and the status of strategy implementation within the Company.
Where according to statutory law or the Articles of Association approval of the Supervisory Board was necessary for certain transactions, the Supervisory Board passed resolutions to the extent required.
The Chairman of the Supervisory Board maintained regular personal and telephone contact with the Chairman of the Board of Management outside the Supervisory Board meetingsto obtain information on the business development, key businesstransactions and upcoming decisions as well as long‐term perspectives and considerations on emerging developments. The Chairman of the Supervisory Board and the Chairwoman/Chairman of the Audit Committee also automatically received all Internal Audit reports. The members of the Supervisory Board also discussed current issues with the Board of Management outside of the meetings.
In the 2024 financial year conflicts of interests involving members of the Board of Management or Supervisory Board, which had to be disclosed to the Supervisory Board without delay and reported to the Annual Shareholders' Meeting, did not occur.
The Supervisory Board held nine meetings in the 2024 financial year, which were held as hybrid meetings, i.e. as face‐to‐face meetings with the option to participate in virtual form. Seven further resolutions were passed by circular resolution. In connection with the fulfilment of their duties, the members of the Supervisory Board had sufficient opportunity, both in the committees and in plenary sessions, to critically and comprehensively examine the reports and proposed resolutions submitted by the Board of Management. They were able to contribute their own suggestions to discussions at any time.
MAIN FOCUS AT SUPERVISORY BOARD DELIBERATIONS
The Company's negotiations on financing and liquidity improvement were of central importance for the Supervisory Board's discussions in the 2024 financial year. The Supervisory Board discussed the various options for securing financing, in particular negotiations with potential financing partners. The Supervisory Board's deliberations were also characterised by discussions on the approval of Yimmugo® in the USA as well as the schedule and distribution of the product.
An extraordinary meeting of the Supervisory Board on 16 January 2024 dealt intensively with the new management structure and the ongoing maintenance and upgrade work in production. The Board of Management provided an update on an IT incident in November 2023. The preliminary figures for 2023 were discussed. The Supervisory Board approved the budget proposal for 2024 and discussed the challenges and assumptions for the coming year.
On 13 March 2024, the Supervisory Board approved by way of circular resolution the third amendment to the shareholder loan agreement between Biotest AG and Grifols Biotest Holdings GmbH.
On 15 March 2024, the Supervisory Board approved by way of circular resolution the Management Declaration for the 2023 financial year, including the DCGC Declaration of Compliance, the declaration of Non‐Financial Information/Sustainability Report and the Remuneration Report for the financial year 2023.
In its meeting on 21 March 2024, the Supervisory Board resolved to postpone the resolution on the approval of the annual financial statements and the consolidated financial statements for 2023 for Biotest AG, the report of the Supervisory Board and the dependency report and the invitation to the Annual General Meeting until 25 March 2024. At the proposal of the Audit Committee, the Supervisory Board unanimously resolved to propose to the Annual General Meeting, that Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, Germany, be appointed as auditor for the annual and consolidated financial statements for 2024.
On 21 March 2024, the Supervisory Board also approved the proposal of the Personnel and Compensation Committee regarding the achievement of the performance targets of the members of the Board of Management for 2023 and approved the performance targets of the members of the Board of Management for 2024. At the proposal of the Personnel and Compensation Committee, the Supervisory Board also unanimously approved the proposed LTIP plan 2024‐2027.
On 25 March 2024, the Supervisory Board approved the 2023 annual financial statements for Biotest AG and the 2023 consolidated financial statements and the proposal to the Annual General Meeting on the appropriation of profits by circular resolution. In addition, the Supervisory Board approved the Supervisory Board report and the audited dependency report. At the suggestion of the Audit Committee,the Supervisory Board took note ofthe EMIR report forthe 2023 financial year. The Supervisory Board unanimously approved the agenda of the Annual General Meeting 2024.
On 7 May 2024, the refinancing negotiations and the status of the Yimmugo® product approval in the USA were discussed. The Supervisory Board discussed the challenges in the Middle East and Africa as well as the progress of the Fibrinogen qualification and Trimodulin studies. The commercial business in Middle East and Africa was discussed by the Supervisory Board.
At the extraordinary meeting of the Supervisory Board on 22 May 2024, the status of the refinancing negotiations and the options for securing liquidity were discussed. The IRAK tender 2025/2026 and the distribution of Yimmugo® in the USA were also discussed. The Supervisory Board unanimously approved the Board of Management's proposal for the distribution of Yimmugo® in the USA.
At the meeting on 17 July 2024, the Supervisory Board discussed the business performance for the first half‐year of 2024 and the further objectives for the second half of the year. The Company's financial situation and the status of developments and approvals of new products were discussed.
At the meeting on 29 July 2024, the Supervisory Board was informed about the current financial situation of Biotest AG, in particular the repayment of the loan to Alcentra. The Supervisory Board discussed how to proceed. The Supervisory Board emphasised the need for a quick and effective solution to ensure the Company's financial stability.
At the meeting on 3 September 2024, the Board of Management informed the Supervisory Board about the current status of negotiations on financing, cash flow improvement measures and the liquidity situation, as well as delays in the production and FDA approval of Yimmugo®. The Supervisory Board discussed the additional financing options. The next steps to secure financing and improve liquidity were determined.
By circular resolution dated 9 September 2024, the Supervisory Board removed Ms Ainhoa Mendizabal Zubiaga from the Board of Management of Biotest AG as she wanted to leave the Company for personal reasons. By circular resolution dated 11 September 2024, Mr Martin Möller was appointed as the new Chief Financial Officer (CFO) on an interim basis until 15 March 2025.
Ms Uta Kemmerich‐Keil resigned as member of the Supervisory Board and as chairwoman of the Audit Committee for personal reasons as of 30 September 2024.
At the joint meeting of the Audit Committee and the Supervisory Board on 8 October 2024, the Supervisory Board approved the conclusion of a shareholder loan agreement with Grifols, S.A. The Supervisory Board also authorised the Board of Management to raise further financing in the form of shareholder loans within the terms of the signed shareholder loan agreement until the end of 2024. The initiatives to improve liquidity and secure financing were also discussed. The Supervisory Board emphasised the importance of robust compliance management and effective internal auditing.
On 15 November 2024, the Supervisory Board approved the court's appointment of Prof Dr Gernot Hebestreit as a new member of the Supervisory Board and designated Chairman of the Audit Committee by way of a circular resolution.
At its meeting on 9/10 December 2024, the Supervisory Board discussed the strategic direction of Biotest AG, taking into account market developments. The focus was on analysing the Company's own market position with regard to its own strengths, weaknesses, risks and opportunities. The Supervisory Board also discussed corporate strategy, with a focus on Biotest AG's financial planning. To this end, the available financing options were analysed and evaluated. In addition, Prof Dr Gernot Hebestreit was elected Chairman of the Audit Committee.
COMMITTEES
The Supervisory Board formed committees in the reporting year in order to perform its duties efficiently. The two committees of the Supervisory Board are made up as follows:
Personnel and Compensation Committee
Dr. Bernhard Ehmer (Chairman)
Raimon Grifols Roura
Jürgen Heilmann
Audit Committee
Uta Kemmerich‐Keil (Chairwoman, until 30 September 2024)
Prof Dr Gernot Hebestreit (Chairman, from 9 December 2024)
David Bell
Dr. Bernhard Ehmer
Dirk Schuck
The Audit Committee met three times with the Board of Management in the 2024 financial year, including once together with the Supervisory Board. The meetings were held as hybrid meetings. One resolution was passed by circular resolution. The Chairwoman/Chairman of the Audit Committee was also in regular contact with the Board of Management and the auditor outside of the meetings. The meetings and resolutions were prepared by reports and other information from the Board of Management. The heads of the relevant Group functions reported on individual items on the agenda and were available to answer questions. The committee chairperson informed the Supervisory Board promptly and comprehensively about the content and results of the committee meetings. At its meetings, the Audit Committee dealt with the Company's and the Group's accounting, including the financial reports during the year, and discussed these with the Board of Management. The auditor also took part in the meetings of the Audit Committee. The Audit Committee deemed it necessary for the Board of Management to attend all meetings in the 2024 financial year.
On 21 March 2024, the Audit Committee discussed the final reports for the 2023 financial year. The Audit Committee resolved to propose to the Supervisory Board to postpone the resolution on the approval of the 2023 annual financial statements and the 2023 consolidated financial statements for Biotest AG, the report of the Supervisory Board, the audited dependency report and the invitation to the Annual General Meeting to 25 March 2024 in order to resolve technical issues in connection with the auditor's report. The auditor's report was presented. The Audit Committee also resolved to propose that the Supervisory Board resolve to propose to the Annual General Meeting that Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, be appointed as auditor.
On 25 March 2024, the Audit Committee resolved by circular resolution to propose to the Supervisory Board that it approves the 2023 annual financial statements, the 2023 consolidated financial statements, the proposal to the Annual General Meeting on the appropriation of profits and the agenda for the 2024 Annual General Meeting, the dependency report and the report of the Supervisory Board.
At the meeting on 8 October 2024, the Audit Committee met jointly with the Supervisory Board, as the Audit Committee remained without a chairperson following the resignation of the committee chairwoman. At the meeting, the Audit Committee discussed risk and compliance management. In the further course of the meeting, the auditor explained the updated audit plan for the 2024 audit and the results of the preliminary audit.
At the meeting of the Audit Committee on 10 December 2024, which was also attended by the auditor, the Audit Committee was informed about the status of the internal audit and compliance with the SOX Act, with measures to ensure compliance despite personnel changes within Biotest AG being discussed. Another focus was on the status of the Corporate Sustainability Reporting Directive (CSRD) and the implementation of the European Sustainability Reporting Standards (ESRS), with the Audit Committee deciding to recommend that the Supervisory Board uphold the Board of Management's goal of publishing a sustainability report in accordance with ESRS and an audit with limited assurance. The auditor presented the updated audit plan for the 2024 annual financial statements. Finally, the Audit Committee discussed the terms and conditions of the existing D&O insurance.
The Personnel and Compensation Committee met twice in the reporting year. The meetings were held as hybrid meetings. Two resolutions were passed by circular resolution.
On 7 January 2024, the Personnel and Compensation Committee of the Supervisory Board resolved by circular resolution to propose to the Supervisory Board an adjustment to the remuneration of Ms Ainhoa Mendizabal Zubiaga due to her new responsibilities following the change of CEO. The resolution of 7 January 2024 was corrected by a new circular resolution on 29 January 2024.
At the meeting on 21 March 2024, the Personnel and Compensation Committee discussed the achievement of the targets for the Board of Management in the 2023 financial year, new targets for the Board of Management for the 2024 financial year and the LTIP.
At the meeting on 17 July 2024, the Personnel and Compensation Committee discussed the effectiveness of its work, the LTIP 2024 and the future role of Dr Schüttrumpf.
INDIVIDUAL ATTENDANCE AT MEETINGS
The meetingsin the reporting year were held asface‐to‐face meetings with the option to participate in virtual form (hybrid meetings). The participation of the members of the Supervisory Board in the meetings of the Supervisory Board and the committeesis disclosed below in individualised form. In each case, only the meetings that took place during the respective membership of the Supervisory Board or committee are disclosed.
| Supervisory Board | Plenary meeting | Audit Committee | Personnel and Compensation Commitee |
|||
|---|---|---|---|---|---|---|
| Dr Bernhard Ehmer (Chairman) | 9/9 | 100% | 3/3 | 100% | 2/2 | 100% |
| David Bell | 9/9 | 100% | 3/3 | 100% | 1/1* | 100% |
| Uta Kemmerich‐Keil, until 30 September 2024 | 7/7 | 100% | 1/1 | 100% | ‐ | ‐ |
| Prof. Dr Gernot Hebestreit, from 9 December 2024 | 1/1 | 100% | 1/1 | 100% | ‐ | ‐ |
| Dirk Schuck | 9/9 | 100% | 3/3 | 100% | ‐ | ‐ |
| Jürgen Heilmann | 9/9 | 100% | ‐ | ‐ | 2/2 | 100% |
| Raimon Grifols Roura | 8/9 | 89% | ‐ | ‐ | 1/2* | 50% |
| Participation rate (total) | 98% | 100% | 88% | |||
*Mr David Bell attended the meeting of the Personnel and Compensation Committee on 17 July 2024 as a substitute for Mr Raimon Grifols Roura, who was excused.
CORPORATE GOVERNANCE
Also in 2024, the Supervisory Board continuously complied with the further development of corporate governance standards within the Company. The Board of Management and the Supervisory Board reported on the corporate governance of the Company in the Corporate Governance Statement in accordance with Principle 22 of the German Corporate Governance Code which was published together with the Declaration of Compliance regarding the recommendations of the government commission on the German Corporate Governance Code in accordance with Section 161 of the German Stock Corporation Act (AktG). On 5 March 2025, the Board of Management and the Supervisory Board of Biotest AG issued a Declaration of Compliance with the recommendations of the government commission on the German Corporate Governance Code in accordance with Section 161 of the German Stock Corporation Act.
CHANGES TO THE BOARD OF MANAGEMENT AND THE SUPERVISORY BOARD
In the financial year 2024, the following changes have taken place in the Board of Management and the Supervisory Board:
Dr Jörg Schüttrumpf has left his position as a member of the Board of Management of Biotest AG at his own request on 31 August 2024 in order to take up a position at Grifols, S.A. Ms Ainhoa Mendizabal Zubiaga left the Board of Management of Biotest AG on 10 September 2024 at her own request. Mr Martin Möller was appointed to the Board of Management of Biotest AG as of 15 September 2024. The appointment is limited until 15 March 2025. As Chief Financial Officer (CFO), Mr Möller is responsible for Finance, Controlling, IT, Legal, Compliance, Investor Relations and Procurement within the Biotest Group.
The Supervisory Board would like to thank Ms Mendizabal and Dr Schüttrumpf for their many years of commitment and trusting cooperation.
There were the following changes to the Supervisory Board in the current 2024 financial year. Ms Uta Kemmerich‐Keil resigned from her position as a member of the Supervisory Board and Chairwoman of the Audit Committee as of 30 September 2024 for personal reasons. Prof. Gernot Hebestreit was appointed as a new member of the Supervisory Board by court order on 28 November 2024 until the end of the next Annual General Meeting, but no longer than 31 December 2025. On 9 December 2024, the Supervisory Board elected him as Chairman of the Audit Committee of Biotest AG.
FINANCIAL STATEMENTS AND CONSOLIDATED FINANCIAL STATEMENTS
Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, Germany audited the consolidated and the end of year statement of Biotest AG by 31 December 2024 as well as the management report and the group management report and provided an unqualified opinion. Further, the aforementioned auditor reviewed the report on the Company's relations to affiliated companies (dependency report) and provided an unqualified opinion:
"Based on our audit performed in accordance with professional standards and our professional judgment, we confirm that:
-
- The factual statements contained in the report are correct.
-
- The consideration paid by the Company for the legal transactions stated in the report was not excessive."
The external auditor engaged by the Supervisory Board to review the content of the separate non‐financial statement also issued an unqualified opinion.
The dependency report, the non‐financial statement, the proposal for the appropriation of profits, as well as the annual and consolidated financial statements, were made available to all members of the Supervisory Board in a timely manner. They were thoroughly discussed in the Audit Committee meeting on 24 March 2025, and in the Supervisory Board meeting on 24 March 2025. In both meetings, the auditor reported on the key findings of the audit and was available for questions and additional information. Afterits own review and discussion ofthe Management Board's proposal forthe appropriation of profits, and the dependency report, as well asthe Management Board'sstatement on the dependency report,the Supervisory Board determined that it had no objections and approved the dependency report and the proposal for the appropriation of profits. Since questions related to the audit of the non‐financial statement were open, the auditor finalised the audit on 28 March 2025.
The final draft of the auditor's audit report was available on 26 March 2025. The members of the Audit Committee and the Supervisory Board had sufficient opportunity to review the final draft after it was presented. After its own review and discussion of the annual and consolidated financial statements, the combined management report, as well as the separate non‐financial statement, the Supervisory Board determined that it had no objections and agreed with the audit results of the auditor and the external auditor. After the unqualified audit opinion was presented on 28 March 2025, the Supervisory Board approved the annual financial statements and the consolidated financial statements for the 2024 financial year prepared by the Management Board on 28 March 2025. The annual financial statements are thus established.
The Supervisory Board would like to thank the Board of Management and all employees for their constant commitment and constructive cooperation, without which the positive development of the Company in financial year 2024 would not have been possible
Dreieich, 28 March 2025
Dr. Bernhard Ehmer Chairman
GLOSSARY / TECHNICAL TERMS
A
ALBUMIN (OR HUMAN ALBUMIN)
Protein produced in the liver that serves to maintain plasma volume and acts as a transport vehicle for many physiological and pharmacological substances.
ANTIBODIES
Proteins produced by special cells of the immune system as a defence reaction against various disease pathogens.
ANTIBODY DEFICIENCY SYNDROME
The body's inability to produce sufficient antibodies. A distinction is made between primary (congenital) and secondary (acquired) antibody deficiency syndromes.
C
CAP
Community‐acquired pneumonia (CAP) refers to pneumonia caused by pathogens that were picked up outside the hospital.
CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare inflammatory disease of the peripheral nervous system, starting with an increasing weakness in legs and sometimes arms. The increasing state of weakness develops over a period of two or more months. This is the main diagnostic criterion for differentiating CIDP from Guillain‐Barre syndrome. The disease is caused by a damage of the myelin sheath that encases the nerve fibres.
COAGULATION FACTORS
Proteins responsible for blood coagulation
CYTOMEGALOVIRUS (CMV)
Usually harmless infection caused by cytomegalovirus (CMV). If it occurs during pregnancy, it can cause severe damage to the unborn child. As the viruses stay permanently in the body after an infection, there can be serious consequences in case of reactivations or new infections in the event of a suppressed immune system. One of the most common virus infections in organ transplantation, which can lead to loss of the transplant.
F
FACTOR VIII
The coagulation factor VIII or anti‐haemophilic globulin A is an essential element of blood clotting. A lack resultsin haemophilia A. An excess can cause thrombus formation combined with an increased risk of venous thrombosis and pulmonary embolisms.
FIBRINOGEN
Protein produced in the liver that plays a central part in blood coagulation. During clotting, it is converted to fibrin, which acts like a glue in the blood for sealing wounds. A fibrinogen deficiency is one possible cause of blood coagulation disorders.
FOOD AND DRUG ADMINISTRATION (FDA)
US‐American agency responsible for monitoring foods and licensing drugs.
FRACTIONATION (PLASMA FRACTIONATION)
Process for obtaining proteins from human blood plasma.
G
GUILLAIN‐BARRÉ‐SYNDROME (GBS)
Guillain‐Barré syndrome is an acute or sub‐acute neurological disease in which inflammatory changes occur in the peripheral nervoussystem. The nerve roots arising from the spinal cord and the associated anterior or proximal nerve sections are mainly affected.
H
HAEMATOLOGY
Branch of medicine that involves blood and diseases of the blood.
HAEMOPHILIA
A blood clotting disorder resulting from defective or missing coagulation factors VIII (type A haemophilia) or IX (type B haemophilia).
HEPATITIS
Inflammation of liver, which can be attributed to various causes, especially virus infections and autoimmune diseases. It leads to death or damage of liver cells and to impairment or even cessation of the liver's metabolic functions. Liver transplantation is often necessary.
HUMAN ALBUMIN
See ALBUMIN.
I
IMMUNE SYSTEM
Totality of all factors responsible for recognising and defending against infectious agents in the body and which exercise control over self‐destructive processes.
IMMUNE THROMBOCYTOPENIA (ITP)
Idiopathic Thrombocytopenic Purpura (ITP) belongsto the group of autoimmune diseases. Its main characteristic is the destruction of thrombocytes in the spleen. As the full‐blown disease (including internal bleedings; purpura) is rare, today the term Immune Thrombocytopenia is more often used.
IMMUNOGLOBULINS
Synonymous with antibodies. They recognise and bind disease pathogens, facilitating their destruction by cells of the immune system.
IMMUNOGLOBULIN G (IgG)
IgG are the most important group of immunoglobulins as they account for approximately 80 % of all immunoglobulins. They circulate in human plasma and exist in body secretions.
IMMUNOGLOBULIN M (IgM)
Largest antibody molecule in the plasma. In conjunction with the complement system (a system of plasma proteins that is activated as part of the immune response), it destroys bacteria and neutralises bacterial toxin.
IMMUNOLOGY
The study of immune defences and immune regulation that enables the body to fight disease pathogens.
INDICATION
The area of therapeutic use for which a substance or medication can be developed and authorised.
INTENSIVE CARE MEDICINE
Medical specialty that deals with the diagnosis and treatment of life‐threatening conditions.
INTRAVENOUS (I.V.)
Administration of a medication through an injection into a vein.
K
KAWASAKI SYNDROME
Kawasaki syndrome is an acute, febrile, systemic illness characterised by inflammation of the small and medium‐sized arteries. In addition, systemic inflammation is present in many organs.
L
LIVER TRANSPLANTATION
A liver transplant isthe surgical transplantation of a liver or parts of a liver into a patient with liver disease.
M
MONOCLONAL ANTIBODIES
Antibodies whose production can be traced back to a single cell of origin and that specifically recognise and bind only one particular antigen.
P
PAUL‐EHRLICH‐INSTITUT (PEI)
German Federal Institute for Vaccines and Biomedicines. The PEI examines and evaluates benefits and risks of biomedical drugs and is responsible, among other things, for the approval of clinical trials, the authorisation of vaccines and preparations derived from human plasma and for the release for sale of production batches.
PHARMACOKINETICS
The sum of all processes that a medication undergoes in the body, from its absorption into the bloodstream to its distribution in the body, biochemical conversion and breakdown, and elimination of the substance (release, absorption into the bloodstream, distribution in the organism, metabolisation, elimination).
PHARMACOVIGILANCE
Systematic monitoring of a drug's safety to identify undesirable effects and take appropriate risk minimisation measures.
PHASE I
The development of a drug is divided into so‐called clinical phases. Approval for a clinical trial in the next higher phase is usually only granted by the relevant regulatory authority if the previous trial phase has been successfully completed. In a phase I study, the drug is used for the first time in healthy volunteers and the pharmacokinetics, pharmacodynamics, tolerability and safety of the drug are investigated.
PHASE II
In a Phase II study, the therapy concept is tested (Proof of Concept, Phase IIa), the appropriate therapy dose is determined (Dose Finding, Phase IIb) and the positive effects of the therapy are observed.
PHASE III
In a phase III study, significant proof of efficacy (pivotal study) and market approval of the therapy is obtained.
PHASE I/III
A pivotal, adaptive clinical trial that initially investigates both pharmacokinetics and safety (Phase I) and subsequently efficacy (Phase III) at first use in humans.
PLACEBO
A dummy medication. Medically inactive substance that is used to meet a subjective need for drug therapy. In many clinical studies, a control group is treated with placebo. The results are compared with those of the participants who have received the trial drug (verum).
PLASMAPHERESIS
Obtaining of plasma from whole blood. The cellular components are returned to the donor by centrifugation. This leaves blood plasma, a clear yellowish fluid, which contains the blood's solu‐ ble protein components.
PLASMA PROTEINS
Collective term for blood proteins that occur most commonly in the blood plasma.
PLASMA PROTEIN THERAPEUTICS ASSOCIATION (PPTA)
Association of the world's leading manufacturers of plasma pro‐ teins.
PRIMARY IMMUNE DEFICIENCY (PID)
Congenital defect in the immune system that results in a defi‐ ciency of antibodies.
R
RANDOMIZATION
Randomization (also random assignment) is a procedure in which the test subjects (for example participating patients) are assigned to different groups using a random mechanism. This is intended to distribute known and unknown personal confound‐ ing variables evenly between experimental and control groups.
RECOMBINANT
Produced with the aid of genetically modified microorganisms or cell lines.
S
SEVERE COMMUNITY ACQUIRED PNEUMONIA (sCAP)
Spread of the inflammation from the lung to the body often re‐ sults in complications such as sepsis, septic shock or organ fail‐ ure.
STANDARD OPERATING PROCEDURE (SOP)
A Standard Operating Procedure (SOP) is a binding written de‐ scription of process flows including the checking of results and their documentation especially in areas with critical processes with the potential to affect the environment, health or safety. SOPs are used in the official marketing authorisation of products and services and are found in the pharmaceutical industry and elsewhere.
SUBCUTANEOUS (S.C.)
In anatomical terms, the layer of tissue beneath the skin. This consists mainly of connective tissue and fat. The subcutaneous application of a drug is an injection under the skin.
V
VARICELLA ZOSTER VIRUS
A virus belonging to the herpes virus family. The first infection usually leads to chickenpox. Reactivation, for instance if the im‐ mune system is weakened, can lead to shingles.
VERUM
A verum is a drug sample (tablet, infusion solution, etc.) admin‐ istered as part of a clinical trial that contains pharmacologically active substances, in contrast to a placebo without active ingre‐ dients.
GLOSSARY / FINANCIAL TERMS
C
CASH FLOW
Actual movement of cash into or out of the company in a period (inflows and outflows). An indicator of a company's internal fi‐ nancing ability.
CONTRIBUTION MARGIN
A category used in cost accounting. Difference between revenue and variable costs.
CURRENCY OPTION
Transaction that hedges the risk of fluctuations in exchange rates. The buyer of a currency option acquires the right, but not the obligation, to purchase orsell a currency at a specific rate on a specified date.
D
DEFERRED TAXES
Income taxes payable or receivable in the future, which do not constitute actual receivables or payables at the time the finan‐ cial statements are prepared.
DERIVATIVE
Financial instrument, the price of which is based on market‐re‐ lated factors. Used among other things to hedge against fluctu‐ ations in value.
DIRECTORS' DEALINGS/MANAGERS' TRANSACTIONS
Transaction in securities issued by a listed company executed by the company's management or related companies or persons.
E
EAT
Earnings after taxes.
EBIT
Earnings before taxes, financial result and result from joint ven‐ tures (operating result).
EBIT adjusted
Earnings before interest and taxes excluding special effects such as expenses in connection with the Biotest Next Level invest‐ ment project.
F
FACTORING
Financial service. The factor acquires a company's accounts re‐ ceivables due from the company's debtors.
FAIR VALUE
A rational and unbiased estimate of the potential market price of an asset or liability.
FINANCIAL ASSETS AT AMORTISED COSTS (AC)
A financial instrument class as defined in IFRS 9.
FINANCIAL ASSETS AT FAIR VALUE THROUGH PROFIT OR LOSS (FAFVtPL)
A financial instrument class as defined in IFRS 9.
FINANCIAL LIABILITIES AT AMORTISED COST (FLAC)
A financial instrument class as defined in IFRS 9.
FINANCIAL LIABILITIES AT FAIR VALUE THROUGH PROFIT OR LOSS (FLFVtPL)
A financial instrument class as defined in IFRS 9.
G
German Commercial Code (Handelsgesetzbuch, HGB)
Important legal basis for all commercial transactions of compa‐ nies in Germany.
H
HEDGE ACCOUNTING
Accounting technique. Creates hedging relationships between the underlying transaction and the derivative financial instru‐ ments used for hedging purposes.
L
LONG‐TERM‐INCENTIVE‐PROGRAMM (LTIP)
Long‐term performance‐related variable remuneration pro‐ gramme.
N
NET PRESENT VALUE
Key business indicator for dynamic capital budgeting, in which payments that occur at any point in time are made comparable
EBT
Earnings before taxes.
by discounting such payments back in time to the start of the investment. The net present value is the sum of the present val‐ ues of all payments (inflows and outflows) resulting from the in‐ vestment.
O
ORDINARY SHARE
A share that confers voting rights and is the counterpart to the preference share.
P
PREFERENCE SHARE
Share without voting rights, but which entitles the holder to a preferred and generally higher dividend. The counterpart to a preference share is the ordinary share.
PROMISSORY NOTE
Form of (long‐term) debt financing for companies, in which a borrower is granted a loan by different creditors through the provision of capital.
R
RETURN ON CAPITAL EMPLOYED (ROCE)
A measure of the return that a company realises on its capital.
S
SENSITIVITY ANALYSIS
Used to determine the impact of specific factors on certain per‐ formance indicators.
SHARE
A share is a security that securitizes a share in a stock corpora‐ tion. A share is a financial instrument within the meaning of the German Securities Trading Act and the German Banking Act.
SWAP
Exchange of receivables and liabilities in the same or a foreign currency with the aim of obtaining a financing, interest rate or yield advantage.
W
WEIGHTED AVERAGE COST OF CAPITAL (WACC)
The weighted average cost of capital approach denotes an ap‐ proach that forms part of the discounted cash flow methods used for valuing companies. This method is also often called the free cash flow method. It is mostly used to determine the mini‐ mum rate of return for investment projects.
WORKING CAPITAL
Short‐term tied‐up capital.
FINANCIAL CALENDAR
ACKNOWLEDGEMENTS
12 MAY 2025 Three‐month report
2 JULI 2025 Annual General Meeting
04 AUGUST 2025 Half‐year report
10 NOVEMBER 2025 Nine‐month report
PUBLISHER Biotest AG Landsteinerstr. 5 63303 Dreieich Germany www.biotest.com
IR contact Dr Monika Baumann Phone: +49 6103 801 4406 Fax: +49 6103 801 347 [email protected]
PR contact Dirk Neumüller Phone: +49 6103 801 269 [email protected]
CONCEPT AND DESIGN Scheufele Hesse Eigler Kommunikationsagentur GmbH, Frank‐ furt am Main, Germany
PUBLISHING SYSTEM AMANA consulting GmbH, Essen, Germany
EDITORIAL OFFICE AND PROJECT MANAGEMENT GFD Finanzkommunikation | Team Farner, Frankfurt am Main, Germany
The annual report contains forward‐looking statements on overall economic development as well as on the state of business, results of operation, cash flows and financial position of Biotest AG and its subsidiaries. These statements are based on current plannings, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developmentsfrom expected developments. The forward‐looking statements are only valid at the time of publication of this annual report. Biotest does not intend to update the forward‐looking statements and assumes no obligation to do so.
