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Biotest AG — Interim / Quarterly Report 2021
Nov 11, 2021
66_10-q_2021-11-11_405b8834-97cc-4b41-ae02-e67233ac22f4.pdf
Interim / Quarterly Report
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QUARTERLY STATEMENT 1 JANUARY TO 30 SEPTEMBER 2021

CONTENTS
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- 9 Outlook, risk and opportunities reports 15 Acknowledgements
- 11 Supplementary report
- 2 Business performance 12 Consolidated statement of income
- 7 Research and development 13 Consolidated statement of financial position
- 8 Marketing and distribution 14 Consolidated cash flow statement
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BUSINESS PERFORMANCE
A. AT A GLANCE
The Biotest Group recorded revenue of € 371.4 million in the first nine months of financial year 2021 (same period of the previous year: € 341.6 million). This represents an increase of € 29.8 million or 8.7% over the figure for the same period of the previous year.
EBIT at Group level amounted to € -11.2 million in the first nine months of financial year 2021 (same period of the previous year: € -7.8 million).
Biotest closed the third quarter with strong growth in revenue of € 6.8 million or 6.4% year-on-year to € 113.6 million (Q3 2020: € 106.8 million), characterised by rising global demand for immunoglobulins while the pandemic situation remained difficult. In particular, sales of Biotest's immunoglobulin preparation Intratect® were significantly higher than in the previous year.
The continuous expansion of the Company's own plasma collection network in Europe is one component of Biotest's strategy. This is intended to ensure a sufficient supply of human blood plasma, the most important raw material for Biotest's preparations. In the financial year 2021, Biotest managed to continue the expansion of its plasma collection capacity. In the second quarter 2021, the Hungarian health authority granted the operating licence for the tenth plasmapheresis centre in Hungary. The centre is located in Szombathely and is one of the most modern in Europe. Also in the second quarter 2021, Biotest received the operating licence for the fifth plasmapheresis centre in Czech Republic from the Czech health authority SUKL. The centre is located in Budweis. In July 2021, the Hungarian health authority approved Biotest's eleventh plasmapheresis centre in Hungary. The centre is located in Sopron. Since mid-August 2021, all official approvals for Biotest's sixth plasmapheresis centre in the Czech Republic, located in Brno, have also been obtained. The Company is thus further increasing its plasma production capacities. In total, Biotest had 26 plasma collection centres in Europe at the end of the first nine months of 2021. The Company plans to open additional centres in the future.
Furthermore, Biotest is participating financially in the establishment of further collection centres together with partners. For example, a contract to provide financial support for the establishment of four plasma collection centres was signed in January 2021.
In February 2021, Biotest AG received commitments for research and development grants. Based on these commitments, Biotest can apply to the tax office for an annual research allowance of up to € 1.0 million for the years beginning in 2020.
The next partial acceptance inspection was carried out by the Darmstadt Regional Council (DRC) in March 2021 in the Biotest Next Level expansion project, as part of the granting of the manufacturing authorisation in accordance with Section 13 of the German Medicinal Products Act. The focus of this inspection was on computer system validation and data management. The inspection was completed without any negative findings. Production of the Process Performance Qualification (PPQ) batches commenced in the second quarter, from which the precursors for Albiomin, Haemoctin and Trimodulin are produced in addition to IgG Next Generation. Based on these batches, evidence will then be provided that a product of consistent quality is reliably manufactured at the newly set up production facilities. In addition, the PPQ batches will be used to demonstrate that the production facilities are producing a preparation comparable to that previously produced for clinical trials. The final inspection of the PPQ batches, whose production was inspected on site by the Darmstadt Regional Council, was carried out by the DRC at the beginning of July 2021. The inspection was passed without any critical or serious deficiencies and in the course of this, the manufacturing authorisation was granted in accordance with Section 13 of the German Medicinal Products Act.
The last of the PPQ batches was successfully manufactured at the beginning of August 2021. With the achievement of this milestone, all data on production has been collected and is now being compiled as part of preparing the dossier.
Change in the Supervisory Board
Kerstin Birkhahn retired from the Biotest Supervisory Board as an employee representative on 30 September 2021. Dr. Salome Drechsler, who was elected Mrs. Birkhahn's deputy, succeeded her on 1 October 2021.
Takeover offer by Grifols S.A.
On 17 September 2021, Grifols S.A., a Spanish pharmaceutical company in the plasma industry, announced its decision to make a voluntary public takeover offer for all outstanding ordinary and preference shares of Biotest AG for € 43.00 per ordinary share and € 37.00 per preference share in cash. Grifols S.A. also announced that it signed a share purchase agreement with Tiancheng International Investment Limited regarding the acquisition of all shares of Tiancheng (Germany) Pharmaceutical Holdings AG, the majority shareholder of Biotest AG. On 26 October 2021, Grifols S.A. published the offer document according to Section 11 of the German Securities Acquisition and Takeover Act (WpÜG) for its voluntary public takeover offer to all shareholders of Biotest Aktiengesellschaft, headquartered in Dreieich, Germany. The deadline for acceptance of the offer is 4 January 2022. Under certain circumstances specified in the offer document, the acceptance period for the offer may be extended. The further acceptance period is expected to start on 8 January 2022 and end on 21 January 2022. The offer is subject to the condition precedent of approval clearance by the antitrust authorities in Austria, Germany, Spain (or in case of referral by the European Commission) and Turkey. On 5 November 2021, the Management Board and the Supervisory Board of Biotest AG issued a joint reasoned opinion pursuant to Section 27 (1) of the German Securities Acquisition and Takeover Act (WpÜG) on the voluntary public takeover offer of Grifols S.A. to the shareholders of Biotest AG published on 26 October 2021. The statement of the Works Council is attached hereto as an annex.
Results of operations
The Biotest Group generated revenue of € 371.4 million in the first nine months of 2021 after € 341.6 million in the same period of the previous year. The significant increase by a total of 8.7% was as well recorded in all three segments. The 8.6% (€ 26.1 million) growth in revenue in the Therapy segment resulted in particular from both the increased sales volume and higher sales prices for the important product Intratect®. Significantly higher toll manufacturing contributed to the 7.4% (€ 2.5 million) revenue growth in the Plasma & Services segment.
With the exception of the Intercontinental region, the Biotest Group also recorded revenue growth in all sales regions. The regions Eastern and Southern Europe as well as Central Europe showed double-digit growth of 18.0% and 15.6% respectively. As in the previous year, the Central Europe region made the largest contribution to revenue with € 139.4 million.
| in € million | Q1 - Q3 2021 | Q1 - Q3 2020 | Change in % |
|---|---|---|---|
| Therapy | 329.8 | 303.7 | 8.6 |
| Plasma & Services | 36.3 | 33.8 | 7.4 |
| Other Segments | 5.3 | 4.1 | 29.3 |
| Biotest Group | 371.4 | 341.6 | 8.7 |
SALES BY SEGMENT SALES BY REGIONS
| in € million | Q1 - Q3 2021 | Q1 - Q3 2020 | Change in % |
|---|---|---|---|
| Central Europe* | 139.4 | 120.6 | 15.6 |
| Eastern and Southern Europe* |
95.9 | 81.3 | 18.0 |
| Intercontinental | 57.3 | 62.5 | -8.3 |
| Middle East, Africa and France |
78.8 | 77.3 | 1.9 |
| Biotest Group | 371.4 | 341.7 | 8.7 |
* In the first quarter of 2021, Poland and the Czech Republic were reclassified from the Central Europe region to the Eastern and Southern Europe region. The previous year's figures were adjusted accordingly.
Research and development expenses decreased to € 40.6 million in the first nine months of 2021 after expenses of € 41.9 million in the same period of the previous year. The reduction resulted from a research grants received. Marketing and distribution expenses of € 34.2 million were also below the previous year's level of € 35.6 million. Reasons are the cancellation of congresses as well as lower travel costs due to the COVID-19 pandemic.
EBIT for the first nine months of financial year 2021 amounted to € -11.2 million (same period of the previous year: € -7.8 million). This includes expenses for the Biotest Next Level project in the amount of € 57.5 million (same period of the previous year: € 59.3 million). The decline in EBIT compared to the previous year is the result of a disproportionate increase in costs of sales, especially with regard to higher plasma prices, and a low-margin country and product mix compared to the previous year. It was noticeable in the third quarter that the sales prices for plasmatic factor VIII preparations continued to decline.
The EBIT margin at Group level for the first nine months of the current financial year was -3.0% after -2.3% in the same period of the previous year.
At segment level, the Therapy segment showed a significant decline in EBIT compared to the same period of the previous year. The main reasons for this are the increased costs of sales ratio, a low-margin country and product mix compared to the previous year, and one-off effects from insurance compensation of € 5.0 million in the previous year. In the Plasma & Services segment, EBIT of € 6.0 million was achieved in the first nine months of the financial year due to increased sales and special effects.
EBIT BY SEGMENT
| in € million | Q1 - Q3 2021 | Q1 - Q3 2020 | Change in % |
|---|---|---|---|
| Therapy | –16.2 | –4.4 | <100 |
| Plasma & Services | 6.0 | –1.6 | <-100 |
| Other Segments | –1.0 | –1.8 | –44.4 |
| Biotest Group | –11.2 | –7.8 | 43.6 |
| ADJUSTED EBIT | |||
|---|---|---|---|
| in € million | Q1 - Q3 2021 | Q1 - Q3 2020 | Change in % |
| EBIT | –11.2 | –7.8 | -43.6 |
| Expenses for Biotest Next Level* |
57.5 | 59.3 | -3.0 |
| Expenses for mono clonal antibodies |
– | 0.1 | -100.0 |
| ADJUSTED EBIT | 46.3 | 51.6 | -10.3 |
* Expenses for Biotest Next Level mainly included manufacturing costs of € 27.7 million (same period of the previous year: € 26.0 million) and research and development expenses of € 29.3 million (same period of the previous year: € 31.5 million) for products that can be manufactured exclusively in the new facility.
Adjusted for expenses for the Biotest Next Level expansion project, EBIT in the first nine months of 2021 was € 46.3 million and thus, as in the previous year, clearly positive (same period of the previous year: € 51.6 million). The adjusted EBIT margin for the first nine months of the current financial year was 12.5% after 15.1% in the same period of the previous year.
The financial result for the first nine months of the current year continues to be negative at € -16.5 million. This represents a significant improvement compared to the previous year's figure (same period of the previous year: € -22.7 million). The improvement was mainly due to value adjustments on financial instruments measured at fair value (€ 2.5 million) and lower expenses from foreign currency valuation (€ 6.3 million). This was offset by a € 2.6 million increase in interest expenses.
The Biotest Group's earnings after taxes improved to € -28.3 million in the first three quarters of financial year 2021, compared to € -31.8 million in the same period of the previous year. This results in earnings per share of € -0.73 after € -0.81 in the first nine months of 2020.
Financial position
Total assets of the Biotest Group increased from € 1,131.3 million as of 31 December 2020 to € 1,135.4 million as of 30 September 2021.
Non-current assets increased slightly by € 3.8 million. Within the non-current assets, property, plant and equipment decreased by € 2.0 million to € 520.2 million, as the scheduled depreciation was higher than the new investments made. In addition, the item other financial assets increased by € 4.7 million to a value of € 4.9 million as of the reporting date 30 September 2021 due to issued financing.
Current assets increased marginally by € 0.3 million compared to the reporting date of 31 December 2020. This change is due, among other factors, to the increase in inventories in the amount of € 8.0 million to secure the sales planned for the coming months. On the other hand, trade receivables decreased by € 8.4 million and other financial assets by € 7.2 million. The main reasons for the decrease are a reduction in cash deposits with banks and value adjustments on financial assets measured at fair value. By contrast, cash and cash equivalents increased by € 7.9 million to € 79.2 million in the first nine months of 2021.
On the liabilities side, equity amounted to € 412.2 million as of the reporting date 30 September 2021 (31 December 2020: € 441.6 million). The equity ratio thus reached 36.3% at the end of the first nine months of the current financial year(31 December 2020: 39.0%).
Total liabilities rose by € 33.5 million to a total of € 723.2 million over the course of the year (31 December 2020: € 689.7 million). Non-current liabilities increased by € 35.3 million since 31 December 2020 to € 619.4 million as of the reporting date 30 September 2021. This increase is mainly based on an increase in non-current financial liabilities by € 33.8 million, which is predominantly due to the utilisation of a further tranche of a secured loan that was already concluded in 2019 for a total volume of € 240.0 million with a maturity in 2024. At € 103.8 million, current liabilities as of the reporting date 30 September 2021 were below the value of € 105.6 million as of 31 December 2020, which is mainly due to the decrease in trade payables by € 10.5 million and an increase in other liabilities by € 9.2 million.
Cash Flow
The Biotest Group recorded cash flows from operating activities of € 3.3 million in the first nine months of 2021. The cash inflows from operating activities and from the change in working capital exceeded the cash outflows from interest and tax payments. In the same period of the previous year, operating cash flow amounted to € -37.5 million.
Cash flow from investing activities was € -19.4 million in the reporting period (same period of the previous year: € -27.8 million). This was caused, among other factors, by payments for investments in fixed assets and loans to partners to support the establishment of plasma collection centres abroad.
Cash flow from financing activities amounted to € 24.1 million in the first nine months of 2021 (same period of the previous year: € 44.9 million) and is mainly characterised by the utilisation of a loan tranche of € 25.0 million (previous year: € 50.0 million). In addition, there was a repayment of cash deposits for guarantees issued by banks. The payments from financing activities were mainly for the repayment portion of the lease liabilities in accordance with IFRS 16 and for the dividend distribution.
Situation with regard to the COVID-19 pandemic
During the first nine months of 2021 and at the time of publication of this quarterly statement, the effects of the COVID-19 pandemic continued to shape the economic environment of the Biotest Group. Despite the vaccination programmes initiated in many countries at the turn of 2020/2021, there is still a high degree of uncertainty regarding the future course of the COVID-19 pandemic, partly due to the occurrence of viral mutations.
Over the past year, Biotest has rapidly and effectively implemented measures to maintain business operations in 2020, while at the same time providing the best possible health protection for its employees. These measures – for example, increased mobile working and the tightening of hygiene and safety precautions, which are already strict in the pharmaceutical industry – continue to apply. Furthermore, COVID-19 rapid tests were offered to our employees twice a week from March to June 2021. From June to August 2021, Biotest operated its own vaccination centre at Company headquarters in Dreieich. There, employees and relatives living in the same household, as well as employees of companies regularly on duty at the Dreieich site who had not yet received a vaccination, were vaccinated by the Company's team of doctors.
The Biotest Group's business operations have continued with few restrictions at or above the respective previous year's level since the beginning of the pandemic. Nevertheless, it cannot be ruled out that a worsening of the COVID-19 pandemic could have a negative impact on the Biotest Group's business performance.
The safety of the Biotest preparations and the patients treated with them is ensured.
Detailed information on the impact of the COVID-19 pandemic on the Biotest Group is provided in the 2020 Annual Report in a separate section of Chapter A.I Business Model of the Group, subchapter F. External Factors Influencing the Business.
For research activities regarding therapeutic approaches for COVID-19 patients, please refer to the chapter Research and Development in the 2020 Annual Report as well as the Research and Development section of this Quarterly Statement.
B. RESEARCH AND DEVELOPMENT
At € 40.6 million, research and development costs in the first nine months of financial year 2021 were 3.1% lower than in the same period of the previous year (same period of the previous year: € 41.9 million). A complete list of all research and development projects is provided in the 2020 Annual Report (page 19). Biotest managed to make further progress in the following research and development projects in the period from January to September 2021:
| Cytotect | In August 2021, Biotest received approval for a phase III clinical trial in pregnant women for the prevention of CMV infections of the unborn child. |
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|---|---|---|---|---|
| Therapeutic area Intensive Care Medicine | ||||
| Fibrinogen | Phase III registration trial accelerated with an additional patient group: The first patients with pseudomyxoma peri tonei (PMP) have been treated for severe bleeding in the case of acquired fibrinogen deficiency (AdFIrst study no. 995). |
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| Pentaglobin® | The treatment of patients with severe COVID-19 courses with Pentaglobin® is being investigated in two Investigator Sponsored Studies that started at the beginning of 2021. In an international, multicentre, retrospective study at the University of Bochum, data from COVID-19 patients treated with Pentaglobin® is being collected from three countries. In the ACOVACT study, a randomised, controlled, multicentre platform study initiated by the University Hospital AKH Vienna to investigate therapies for COVID-19 patients, patients are being treated with Pentaglobin® in one study arm. Neither study has been completed yet. |
|||
| Trimodulin (IgM Concentrate) | Phase II (ESsCOVID) study on severe COVID-19 disease. 166 patients were enrolled in the study. As communicated in August 2021, the primary endpoints were not met in the phase II clinical trial in patients with severe COVID-19 dis ease. Biotest recently received the complete data set of the ESsCOVID trial. The detailed post-hoc analyses of the complete data set revealed a notable benefit in a relevant subgroup of hospitalised patients with early systemic in flammation. In this subgroup of 96 COVID-19 patients trimodulin was able to markedly reduce both worsening and mortality of patients compared to placebo treated patients. |
RESEARCH & DEVELOPMENT PROGRESS IN THE FIRST NINE MONTHS OF 2021 Therapeutic area Clinical Immunology
Research activities with regard to the treatment of a COVID-19 infection
Biotest also saw considerable potential for Trimodulin in patients with severe pneumonia caused by a COVID-19 infection due to the high similarity of the clinical picture to the patients treated in the CIGMA study. The anti-inflammatory mechanisms of action of Trimodulin could also be demonstrated in laboratory tests in a coronavirus trial. Therefore, a phase II study (ESsCOVID – Escape from severe COVID-19) was initiated involving COVID-19 patients to accelerate the development of Trimodulin in light of the current COVID-19 pandemic. The initial study data showed no improvement in disease progression or mortality Biotest recently received the complete data set of the ESsCOVID trial. Initial data showed that the primary endpoint of the trial was not met in the overall trial population, which included also patients with an already advanced systemic inflammation. However, the detailed post-hoc analyses of the complete data set revealed a notable benefit in a relevant subgroup of hospitalised patients with early systemic inflammation. In this subgroup of 96 COVID-19 patients trimodulin was able to markedly reduce both worsening and mortality of patients compared to placebo treated patients. Biotest considers the reduction of deterioration and mortality rate as a relevant medical benefit indicative to continue the development of Trimodulin in this target population.
The anti-SARS-CoV-2 hyperimmunoglobulin study of the CoVIg-19 Plasma Alliance was terminated. The CoVIg-19 Plasma Alliance was disbanded after the primary endpoint was not met. Biotest has initially suspended the programme to develop a COVID-19 hyperimmune globulin in order to await data from parallel studies by competitors in which patients are treated with a COVID-19 hyperimmune globulin earlier in the course of the disease.
C. MARKETING AND DISTRIBUTION
The first nine months of 2021 were characterised by rising global demand for immunoglobulins (IVIGs) accompanied by rising prices. Some markets, including those that are high-priced, are already reporting supply problems with immunoglobulins (IgGs), and there are signs in many other countries that there will be a product shortage in the months ahead. This is due to the significant decline in plasma donations in 2020, especially in the USA, the supply situation of Biotest's competitors and the continuing increase in demand for immunoglobulins (IgG). Plasma collection volumes in the USA will remain at a low level in 2021, so that a short-term recovery of the IgG supply situation is not to be expected.
Intratect was successfully launched in France for the first time and has recorded significantly high sales since then. In addition, the subsidiary in the United Kingdom was also able to significantly increase Intratect sales and thus gain market share in an important market.
When considering the marketing activities for selected Biotest preparations, Pentaglobin®, for example, is the focus of various activities. Biotest is thus supporting the scientific exchange of doctors who use the preparation as a treatment option for COVID-19 patients who also suffer from bacterial infections. A growing number of secondary bacterial infections have been observed in COVID-19 patients who have a severe course of the disease. The antibodies in Pentaglobin® can bind to a variety of different bacteria as well as their toxins, thus supporting their elimination by the immune system. Furthermore, the IgM component in Pentaglobin® supports the immune system and can thus help to rebalance the often exaggerated immune response in COVID-19 patients. This treatment option was also discussed at a Biotest symposium at the largest international conference for intensive care physicians (ISICEM) that was held again this year in September 2021 as a face-to-face event, but is also available digitally.
The increased use of Pentaglobin® in the treatment of COVID-19 patients with secondary bacterial infection has generated additional sales, particularly in Germany and Italy. Fewer surgeries during the pandemic, the resulting decrease in albumin consumption and continued IgG production have led to increased inventories in the market and falling prices for manufacturers. However, as global vaccination campaigns progress and hospitals resume planned treatments, demand for albumin is expected to increase significantly in the months to come. Coupled with the global shortage of plasma, the onset of an albumin shortage is expected in the first half of 2022. The current global situation, however, does not register an albumin shortage or price increase. Despite the difficult situation, stable sales with Albiomin were achieved in Turkey, Germany and in many countries with subsidiaries in the first nine months of 2021. Falling prices make Biotest less competitive, especially in Latin America.
In the Middle East, Africa and France (MEAF) region, educational medical webinars were held on albumin (long-term therapy in liver cirrhosis and indications for albumin 5% under the new approval in Iran). Further medical webinars on albumin are planned in order to demonstrate the multiple application possibilities (acute renal failure, paediatric intensive care, therapeutic plasmapheresis up to liver cirrhosis) and to position itself as a scientifically competent contact partner. With the resumption of live and hybrid events, Biotest is also focussing again on personal contact and proximity to the market and customers at scientific congresses. As part of these efforts, the International CMV Symposium was held for the first time as a hybrid event in Amsterdam. This scientific conference, which was conducted under the direction of internationally renowned experts, was aimed at physicians from the fields of solid organ and stem cell transplantation in which the Biotest hyperimmune globulin Cytotect is approved and used for the prophylaxis of the clinical manifestation of a CMV infection. In total, more than 260 people participated on-site and online.
Increased marketing activities, a rebound in surgeries and increased opportunities for sales personnel to visit hospitals and physicians in person again resulted in Cytotect sales in the third quarter of 2021 exceeding the level of the same quarter last year.In Germany, the new transfer system NEXTARO was successfully launched for Haemoctin® and has met with a positive response from customers. Following its launch in Germany, Haemoctin® with a halved solvent volume was also launched in Switzerland and is being pursued further. Both projects support the customer-focused strategy in the region. A symposium with renowned speakers was held at the annual conference of the Society for Thrombosis and Haemostasis Research (GTH). In September 2021, the XXXIV Biotest Haemophilia Forum was held in Freising with many internationally recognised experts in attendance.
Besides its research activities, Biotest is also involved in other projects in the fight against the COVID-19 pandemic. One example is the difficult transplant situation in Italy. The COVID-19 pandemic has severely affected the Italian healthcare system, but also and especially the people who have fallen ill. Vulnerable individuals, such as transplant recipients or those waiting for a transplant, need special protection and access to personal protective equipment. Furthermore, the pandemic has also affected the organ donation process. Biotest Italia is donating € 100 thousand to the National Transplant Centre (NTC) with the aim of supporting organ and tissue donation during the COVID-19 pandemic. The funds will be used, among other purposes, to introduce a toll-free telephone number to bring patients into closer contact with transplant centres. Other goals include the implementation of telemonitoring (telemedicine) and the delivery of personal protective equipment to patients' homes.
MARKETING & DISTRIBUTION PROGRESS IN THE FIRST NINE MONTHS OF 2021
Therapeutic area Clinical Immunology
| Hepatect® CP |
Tenders were won in Algeria and Iraq. The volume of tenders won in Iraq was increased. | |
|---|---|---|
| Fovepta® | New market approval received in Vietnam. | |
| Intratect® | Volume increases in key markets such as Central Europe. Increase in list/refund/sales prices in many countries, in cluding Germany, Austria, Hungary, the UK and Spain. Special import licence and initial sales of Intratect® 50 g/l and 100 g/l in France. |
|
| Therapeutic area Haematology | ||
| Haemoctin® | Extension of the FVIII contract for substantial volumes in Algeria. Significant increase in sales in Palestine and Vi etnam. Tender participation in Oman. Increased convenience for patients by introducing a new transfer system in Germany and Switzerland. |
|
| Haemonine® | Significant increase in sales in Germany. New registration and initial sales in Turkey. | |
| Therapeutic area Intensive Care Medicine | ||
| Pentaglobin® | The increased use of Pentaglobin® in the treatment of COVID-19 patients with secondary bacterial infection gener ated additional sales, especially in Germany and Italy. |
|
| Albiomin® | Albiomin 5%: New approval in Iran (toll manufacturing). Albiomin 5% and 20%: New approval in Bangladesh. |
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D. OUTLOOK, RISK AND OPPORTUNITIES REPORT
I. OUTLOOK REPORT
The Biotest Group's outlook has not changed significantly since its presentation in the 2020 Annual Report (pages 24 to 27). As described there, the Board of Management expects, among other developments, an increase in revenue in the mid-single-digit percentage range and EBIT of € -5 million to € -10 million for financial year 2021. In the next quarter, Biotest expects an improved product/country mix as well as rising average prices for immunoglobulins.
The outlook for financial year 2021 was prepared based on the assumption that the spread of the coronavirus will not have any significant negative impact on the Biotest Group's business performance. However, the uncertainty currently prevailing with regard to the further spread of the coronavirus or its mutants and any economic consequences limits the certainty of the planning assumptions.
II. RISK REPORT
The risk situation of the Biotest Group has not changed significantly since it was presented in the Risk Report of the 2020 Annual Report.
This also applies to the assessment of risks in connection with pandemics/epidemics (in the Risk Report of the 2020 Annual Report) and plasma procurement. Uncertainty regarding the further spread of the coronavirus will continue in the period after the reporting date until the time of preparation of the quarterly statement as of 30 September 2021. Possible economic consequences cannot yet be conclusively assessed at the time of preparation of the quarterly financial statements as of 30 September 2021. Should the spread of the coronavirus continue in the long term, this could have a negative impact on the willingness of the population to donate plasma or on the sickness rate of employees, for example. Furthermore, business activities in the regions affected by the pandemic could develop unfavourably and thus have an adverse effect on the asset, financial and earnings positions.
Grifols S.A. announced that it has entered into a share purchase agreement with Tiancheng International Investment Limited for the acquisition of all shares in Tiancheng (Germany) Pharmaceutical Holdings AG, the majority shareholder of Biotest AG. The closing of this transaction would result in a change of control. This could have an impact on Biotest's current financing. At present, the Board of Management assumes that a possible change of control will have no effect on the Company's financing. On completion of the takeover bid by Grifols S.A., a restricted usability of tax loss carry forward as well as interest carry forward – in particular for the Biotest AG – will probably result. So far, no deferred tax assets for the respective loss carry forward were recognized in the consolidated financial statements.
Consequently, there are still no identifiable risks that could jeopardise the Biotest Group's ability to continue as a going concern.
III. OPPORTUNITIES REPORT
The merger of Grifols and Biotest would allow Grifols and Biotestto pool their existing blood plasma resources to achieve greater resource availability and a wider product range. Grifols has also expressed its intention to increase research and development resources at Biotest following a merger in order to accelerate current development projects for new types of proteins such as Trimodulin and Fibrinogen. This provides an opportunity to advance product development and manufacturing faster than would otherwise be possible for Biotest as a single company.
Except for the above, the opportunities situation of the Biotest Group has not changed significantly compared to the information presented in the Opportunities Report of the 2020 Annual Report.
E. SUPPLEMENTARY REPORT
On 26 October 2021, Grifols S.A. published a voluntary takeover offer pursuant to section 11 WpÜG.
On 5 November 2021, the Management Board and the Supervisory Board of Biotest AG issued a joint reasoned opinion pursuant to Section 27 (1) of the German Securities Acquisition and Takeover Act (WpÜG) on the voluntary public takeover offer of Grifols S.A. to the shareholders of Biotest AG published on 26 October 2021. The statement of Works Council is attached hereto as an annex.
There were no events after the balance sheet date that had a significant impact on the net assets, financial position or results of operations.
CONSOLIDATED STATEMENT OF INCOME
of the Biotest Group for the period from 1 January to 30 September 2021
| in € million | Q3 2021 | Q3 2020* | Q1 - Q3 2021 | Q1 - Q3 2020* |
|---|---|---|---|---|
| Revenue | 113.6 | 106.8 | 371.4 | 341.6 |
| Cost of sales | –87.8 | –80.6 | –289.6 | –249.4 |
| Gross profit | 25.7 | 26.2 | 81.7 | 92.3 |
| Other operating income** | 2.7 | –2.3 | 5.1 | 3.8 |
| Marketing and distribution costs | –10.5 | –11.8 | –34.2 | –35.6 |
| Administrative expenses | –6.3 | –5.4 | –21.1 | –21.9 |
| Research and development costs | –13.6 | –14.2 | –40.6 | –41.9 |
| Other operating expenses** | –0.7 | –1.0 | –2.2 | –4.5 |
| Operating profit | –2.6 | –8.5 | –11.2 | –7.8 |
| Financial income*** | 0.7 | 2.6 | 4.9 | 5.6 |
| Financial expenses*** | –8.0 | –9.0 | –21.4 | –28.3 |
| Financial result | –7.3 | –6.4 | –16.5 | –22.7 |
| Earnings before taxes | –9.9 | –14.9 | –27.7 | –30.5 |
| Income taxes | –0.2 | –0.2 | –0.6 | –1.3 |
| Earnings after taxes | –10.1 | –15.1 | –28.3 | –31.8 |
| Attributable to: | ||||
| Equity holders of the parent | –10.1 | –15.1 | –28.3 | –31.8 |
| Earnings per share in € | -0,26 | -0,39 | -0,73 | -0,81 |
* Adjusted
** Other operating income and expenses include the change in impairments on financial assets measured at amortized cost. In accordance with IAS 8, the prior-year figures have been adjusted accordingly.
*** Financial income and financial expenses include the valuation adjustments of financial instruments measured at fair value. In accordance with IAS 8, the prior-year figures have been adjusted accordingly.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
of the Biotest Group as of 30 September 2021
| in € million | 30 September 2021 | 31 December 2020 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Intangible assets | 13.5 | 14.0 |
| Property, plant and equipment | 520.2 | 522.2 |
| Right-of-use assets | 27.2 | 26.1 |
| Investments in joint ventures | 2.6 | 2.6 |
| Other assets | 0.1 | 0.4 |
| Other financial assets | 4.9 | 0.2 |
| Deferred tax assets | 10.3 | 9.5 |
| Total non-current assets | 578.8 | 575.0 |
| Current assets | ||
| Inventories | 298.1 | 290.1 |
| Contract assets | 47.1 | 46.3 |
| Trade receivables | 107.4 | 115.8 |
| Current income tax assets | 0.6 | 2.1 |
| Other assets | 12.2 | 11.5 |
| Other financial assets | 12.1 | 19.3 |
| Cash and cash equivalents | 79.2 | 71.3 |
| Total current assets | 556.6 | 556.3 |
| Total assets | 1,135.4 | 1,131.3 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Subscribed capital | 39.6 | 39.6 |
| Share premium | 219.8 | 219.8 |
| Retained earnings | 181.1 | 213.6 |
| Earnings after taxes | –28.3 | –31.4 |
| Equity attributable to equity holders of the parent | 412.2 | 441.6 |
| Total equity | 412.2 | 441.6 |
| Non-current liabilities | ||
| Provisions for pensions and similar obligations | 120.2 | 117.5 |
| Other provisions | 1.8 | 2.8 |
| Financial liabilities | 496.3 | 462.5 |
| Other liabilities | – | 0.1 |
| Deferred tax liabilities | 1.1 | 1.2 |
| Total non-current liabilities | 619.4 | 584.1 |
| Current liabilities | ||
| Other provisions | 23.3 | 24.2 |
| Current income tax liabilities | 0.7 | 1.2 |
| Financial liabilities | 8.8 | 7.9 |
| Trade payables | 31.5 | 42.0 |
| Other liabilities | 39.5 | 30.3 |
| Total current liabilities | 103.8 | 105.6 |
| Total liabilities | 723.2 | 689.7 |
| Total equity and liabilities | 1,135.4 | 1,131.3 |
CONSOLIDATED CASH FLOW STATEMENT
of the Biotest Group for the period from 1 January to 30 September 2021
| in € million | Q1 - Q3 2021 | Q1 - Q3 2020 |
|---|---|---|
| Operating cash flow | 12.2 | 14.5 |
| Cash flow from changes in working capital | 1.8 | –45.8 |
| Interest and taxes paid | –10.7 | –6.2 |
| Cash flow from operating activities | 3.3 | –37.5 |
| Cash flow from investing activities | –19.4 | –27.8 |
| Cash flow from financing activities | 24.1 | 44.9 |
| Cash changes in cash and cash equivalents | 8.0 | –20.4 |
| Exchange rate-related changes in cash and cash equivalents | –0.1 | –0.2 |
| Cash and cash equivalents on 1 January | 71.3 | 60.8 |
| Cash and cash equivalents on 30 September | 79.2 | 40.2 |
Dreieich, 11 November 2021
Biotest Aktiengesellschaft
Board of Management
Dr. Michael Ramroth Dr. Georg Floß Chairman of the Board of Management Member of the Board of Management
THE FOUR SALES REGIONS OF BIOTEST

FINANCIAL CALENDAR
30 March 2022 Annual Report 2021
03 May 2022 Three-month report
03 May 2022 Annual Shareholders' Meeting
11 August 2022 Half-year report
14 November 2022 Nine-month report
ACKNOWLEDGEMENTS
PUBLISHER Biotest AG Landsteinerstr. 5 63303 Dreieich Deutschland www.biotest.com
IR Contact Dr. Monika Buttkereit 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, Frankfurt am Main, Germany
PUBLISHING SYSTEM AMANA consulting GmbH, Essen, Germany
EDITORIAL OFFICE AND PROJECT MANAGEMENT cometis AG, Wiesbaden, Germany
PHOTOGRAPHY Simone Kiefer, Dreieich, Germany
This 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 developments from expected developments. The forward-looking statements are only valid at the time of publication of this report. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

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