Biotest AG — Audit Report / Information 2023

Mar 28, 2024

BIOTEST GROUP FY 2023 Results, March 28, 2024

Leadership Team

Peter Janssen Chief Executive Officer

Ainhoa Mendizabal Zubiaga Chief Financial Officer

Dr. Jörg Schüttrumpf Chief Scientific Officer

Operational Model of Biotest

Plasma procurement	Fractionation	Purification	Filling/packaging	Distribution
Collection	Biotest P1 ~1,600 TL	1. Intratect (IgG) 2. Pentaglobin (IgM/IgA) 3. Albumin 4. FVIII/Fibrinogen + special products		EU
Purchasing		1. Yimmugo (IgG) 2. Trimodulin (IgM/IgA)	Biotest P3 ~3,000 TL	RoW
Contract manufacturing	Biotest P2 ~1,500 TL	3. Albumin 4. Fibrinogen
Research & contract development			Stateless revenue

BNL Target

Capacity expansion.

New products.

New markets

Increase in profitability

Today	2027
0,3 TL	1,5 TL
1 product	4 products

RAMP-UP BNL – REVENUES
2023 2024 2025 2026	2027	2028	2029

BIOTEST GROUP Biotest Group – Highlights FY 2023

BIOTEST NEXT LEVEL

• Expansion of capacities and further development of the product portfolio
• FDA inspection of Biotest Next Level

RESEARCH & DEVELOPMENT

• Yimmugo©: FDA accepted BLA application; FDA inspection
• Acquired Fibrinogen Deficiency Phase III trial: primary endpoint met
• Trimodulin: two phase III trials ongoing

PLASMA COLLECTION CENTRES

• Expansion of EU plasma collection centres continued: now 37 centres in Germany, Hungary and Czech Republic

COLLABORATION

Biotest AG and Grifols, S.A. have significantly expanded their collaboration

Opportunity for Biotest to produce and market its own new product developments worldwide using Grifols' organisation and production network

BIOTEST GROUP Product Portfolio

Immunoglobulins

Intratect© and Yimmugo©

• Demand for immunoglobulins remains at stable high level, growing globally (+6%)
• Intratect© (5%/10%) sold in Europe and international markets
• Focus on high price markets to continue
• Yimmugo© generated sales of € 27 million in Germany and Austria in 2023

Hepatitis B Hyperimmunoglobulins

Hepatect© , Zutectra© and Fovepta©

• Biotest is market leader for hepatitis B hyperimmunoglobulins
• With declining Hepatitis B cases in developed markets and new antiviral therapies, the market situation is challenging in this area
• Hepatitis B hyperimmunoglobulins received marketing authorisations in several countries e.g. Hepatect© and Fovepta© were authorised in Bangladesh
• Zutectra© was launched in Turkey and Taiwan

Other Hyperimmunoglobulins

Cytotect© and Varitect©

• For Cytotect©, bone marrow transplants and selected areas of solid organ transplantation will continue to be main focus
• Cytotect© received marketing authorisations in several EU countries
• Stable revenues were achieved despite challenges

Haematology Portfolio

Haemoctin© (Factor VIII)

• Haemoctin© – natural complex of factor VIII and von Willebrand factor (Wild type factor)

Haemonine© (Factor IX)

• Haemonine© posted slight growth
• In Germany the Nextaro transfer system introduced for Haemonine© receives good responses

Intensive Care Portfolio

Pentaglobin©

• Pentaglobin© has > 30 years of IgM experience
• Pentaglobin© reduces mortality in sepsis patients
• Promising new indications (e.g. eDSA clearance in lung transplant)
• Pentaglobin© is the only approved (IgM-enriched) immunoglobulin preparation for treatment of severe bacterial infections
• Pentaglobin© revenues increased; growth shown in various European and international markets

Intensive Care Portfolio

Albiomin

• High demand for therapeutic Albiomin in 2023
• Rising prices especially in important markets as China
• Demand for Albumin in Asia is high; expansion of business in China, Indonesia, UK and Italy
• New marketing authorisations obtained in France for Albumin 5% and 20%

Biotest Human Serum Albumin

• Biotest Human Serum Albumin is a multifunctional exipient for Manufacturing and research use, Pharmaceutical Biotechnology and Diagnostic Industry
• Cell media: cell and tissue culture, stem cells, cryopreservation, in vitro fertilisation
• Drug carrier targeted delivery: nanoencapsulation and medical imaging
• Stabiliser: drug and vaccine formulations and cell therapy
• Biotest Human Serum Albumin recorded significant revenue growth in 2023

Marketing Visuals

Hepatect©

Protection Maximized

Zutectra©

Freedom in your Hands

Fovepta©

Simply Protected

Cytotect©

Protecting Precious Life

Varitect©

Counteract Complications

Pentaglobin©

Life. Needs Balance.

BIOTEST GROUP Research & Development

DEVELOPMENT PROJECTS – GENERAL OVERVIEW

PID = Primary Immune Deficiency; ITP = Idiopathic Thrombocytopenic Purpura; sCAP = severe community acquired pneumonia

Fibrinogen – a Critical Blood Clotting Factor

When a blood vessel is injured, several processes are initiated to facilitate healing. Fibrinogen plays a decisive role in this precisely choreographed sequence of clotting events.

DONE

Fibrinogen Trials Status

Congenital FD¹

Treatment of adults and children

• Results confirm high expectations regarding efficacy and safety…
• Study completed

Acquired FD¹ Phase I/III study: in major spinal surgery and pseudomyxoma peritonei (tumor) surgery • Last patient recruited and treated end of Sept. ´23; in total 200 evaluable patients • Positive top line results • Clinical Trial report to be finalised by mid 2024

Two Phase III Trimodulin Trials Ongoing

Randomized, placebo-controlled, double-blind, multi-center, phase III trials investigating the efficacy and safety of Trimodulin in adult hospitalised patients

CAP Patients

• Patients on low-flow oxygen, high-flow oxygen, NIV
• Patients with early systemic inflammation
• Indication was extended from COVID-19 to Community Acquired Pneumonia (CAP), incl. COVID-19
• 60 study centres in 14 countries
• Next step: Interim Analysis, dependent on patient rate recruitment

~590 SUBJECTS

• Patients on invasive mechanical ventilation (within 12 h)
• Patients with inflammation (CRP ≥ 70 mg/L)
• SARS-CoV-2 negative
• 140 study centres in 18 countries planed

BIOTEST GROUP Biotest Next Level

Yimmugo® – Launch in Germany followed by other markets…

• Germany: First sales in November 2022
• Austria: First sales in December 2023
• UK: Marketing authorisation in August 2023
• EU: Registration process initiated in France, Italy, Netherlands, Portugal, Ireland, Norway, Hungary and Sweden
• USA: US Food and Drug Administration (FDA) accepts Biologic License Application (BLA) in August 2023

Biotest Next Level – Ramp-up Manufacturing of Yimmugo®

• The amount of Yimmugo® produced is to be increased to 6–7 batches per week.
• Target: produce more batches more efficiently .
• Challenge:
  • Recruiting of skilled and trained personal
  • Sufficient availability of external service providers regarding automation

Biotest Next Level – FDA Inspection

• December 2023: Pre-License Inspection of Biotest Next Level Manufacturing plant by US Food and Drug Administration (FDA)
• Inspection and validation of quality systems, Yimmugo© manufacturing plant, compliance of the production process with the submitted dossier validated and verified
• Final report expected

BIOTEST GROUP Plasma Collection

Expansion of Plasma Collection Centres

Europe: 37 plasma collection centres

• 2 new centres in Germany in 2024
• 2 new centres in 2023 in Germany and in Hungary
• 7 new centres in 2022 in Czech Republic

Access to US Plasma

• Long-term supply contracts with Grifols and other third parties

Biotest Plasma Collection

Biotest Plasma collection volume: ~90% higher than in 2020

BIOTEST GROUP Collaboration Biotest and Grifols

COLLABORATION BIOTEST AND GRIFOLS

Biotest and Grifols has and will join forces in core markets to strengthen their joint position also by securing plasma supply, optimised manufacturing capacity and a strong research pipeline.

Target: The availability of leading plasma protein therapies should be ensured!

Technology Transfer & License Agreement with Grifols S.A.

Know-how for the development and manufacturing of Yimmugo©, Trimodulin and Fibrinogen has been and will be disclosed and transferred to Grifols with remuneration on three levels

1. For the Technology Disclosure

(6 technology components)

1. For acceleration & completion of the R&D projects

For 1) and 2) Biotest will receive in total a mid three-digit million amount in several installments between 2023 and 2026

1. Grifols will pay Biotest royalties in the high single-digit percentage range of net sales of the licensed products for a period of 30 years from the date of commercialization

Grifols has been granted a semi-exclusive license to manufacture and market three products – Yimmugo©, Fibrinogen and Trimodulin – worldwide.

Total valuation: € 1.1 – 1.6 billion

Master Distribution Agreement

CURRENT FOCUS

• Optimise distribution structures in existing markets
  • e.g. by selling 5 Biotest sales companies (Spain, Italy, Brasil, UK and France) to Grifols and thereby obtaining "one face to the customer"
  • Preparations for Germany for "one face to customer" ongoing
• Exploit additional business opportunities through coordinated collaboration between the two companies

BIOTEST GROUP Biotest Sustainability

Sustainability Projects at Biotest

• Completion of the photovoltaic system
• Heat recovery system implemented
• GoFuture forest: 12,000 trees, absorption of 3,100 tons of CO2 in 10 years
• Improvement in the energy efficiency of production compared to the previous year (> 5%)

Daycare "BioNest"

It is important to us that our employees are able to balance family and career. In our in-house daycare center "BioNest" at the Dreieich location we offer:

• 90 childcare places
• Comprehensive care from ages 0 to school entry
• Opening hours: Monday to Friday 6:00 a.m. 6:00 p.m.
• Indoor play area with ball pit, group rooms and bedrooms
• Outdoor area with sand playground, climbing facility and slide

BIOTEST SUSTAINABILITY

Biotest Sustainability Goals

• Sustainable supply chain as a goal
• Transformation concept for emission reduction and efficient use of resources

BIOTEST GROUP Financials FY 2023

Income Statement (€ million)

	FY 2022	FY 2023	Dev. in %
Sales in regions	516.1	684.6	32.6
European Union thereof:	264.6	260.4	-1.6
Rest of World	251.5	234.1	-6.9
Stateless	–	190.1	>100
COGs and operating expenses	-532.7	-541.1	-1,6
Operating profit (EBIT)	-16.6	143.5	>100
Financial result, taxes	-15.1	-16.5	-9.3
Earnings after tax (EAT) Biotest Group	-31.7	127.0	>100

Revenue 2022 and 2023

• Revenue growth is mainly due to revenue generated from technology disclosure and development services for Grifols S.A., amounting to € 190 million
• Excluding this amount, revenue amounted to € 494.5 million, a 4.2% decrease versus the previous year
• This lower revenue level reflects an IT malfunction that occured at the end of 2023 and which delayed product releases and shifted revenue to the 2024 financial year

REVENUE BIOTEST GROUP € MIO.

EBIT Reported and Adjusted (€ million)

	FY 2022	FY 2023	Dev. in %
EBIT reported	-16.6	143.5	> 100
Earnings from technology disclosure	–	-153.5	< -100
Disposal gain from sale of 5 Biotest subsidiaries	–	-23.1	< -100
Earnings from development services	–	-4.7	< -100
Expenses for Biotest Next Level	77.3	79.4	2.7
EBIT adjusted	60.7	41.6	-31.5

• Adjusted EBIT describes the operating performance of the Biotest Group excluding special effects.
• In order to ensure continuity and comparability, the expenses from the Biotest Next Level expansion project of € 79.4 million (previous year: € 77.3 million) are shown.
• Special effects in 2023 also relate to the first-time income from the technology disclosure of € 153.5 million, from development services of € 4.7 million generated with Grifols, S.A., and the gain on disposal of five Biotest subsidiaries to Grifols, S.A. of € 23.1 million.

Balance Sheet as of 31 December 2023 (€ million)

Cash Flow from Operating Activities

JANUARY – DECEMBER 2023 (€ MILLION)	FY 2022	FY 2023
Operating CF before Changes in Working Capital	19.8	154.0
Cashflow from Changes in Working Capital	-45.2	-120.8
thereof: Changes Inventories	-49.5	-131.2
Changes Trade Receivables	-14.6	-46.3
Other Changes	18.9	56.7
Interest & Tax expense	-15.1	-35.9
Cashflow from Operating Activities	-40.5	-2.7

Guidance 2024

Revenue:

Increase in sales in the upper single-digit percentage range vs. 2023, incl. sales from the technology disclosure and development services for Grifols, S.A.

EBIT:

Operating result expected in the range of € 80 to 100 million for 2024.

Cash Flow:

Positive cash flow from operating activities above the previous year's level.

FINANCIALS FY 2023

Annual General Meeting

Dividend

Proposal to Annual General Meeting for preference shares amounts to € 1.6 million (€ 0.04 per preference share for 2023 and 2022)

The Annual General Meeting of Biotest AG will take place on May 7, 2024, at the Alte Oper, Opernplatz, 60313 Frankfurt/Main, Germany.

Strategic Targets

• Responsible & sustainable growth
• Growth through increased new capacity
• Increased patient access by new products and new markets
• Improved efficiency
• Extended partnerships with Grifols and others

Thank you for your attention.

Financial Calendar 2024

07 May 2024 AGM / Q1 Report 30 Jul 2024 H1 Report

05 Nov 2024 Q1-Q3 Report

Investor Relations Public Relations

Dr. Monika Baumann (Buttkereit) Dirk Neumüller Tel.: +49-6103-801-4406 Tel.: +49-6103-801-269 ir@biotest.com pr@biotest.com

Disclaimer

This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and thus are subject to risks and elements of uncertainty that could result in deviation of actual developments from expected developments.

The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

All comparative figures relate to the corresponding last year´s period, unless stated otherwise.