Biotest AG — Earnings Release 2021

Nov 11, 2021

Biotest AG

Nine Month 2021 Results Conference call

November 11, 2021

• 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.

Facts & Figures Q1-Q3 2021

Biotest Group – Overview Q1-Q3 2021

• Voluntary takeover offer by Grifols, S.A. on Oct. 26, 2021
• Expansion of plasma collection centres ongoing: now 26 centres
• R&D pipeline projects are progressing:
  • IgG Next Generation (IVIG)
  • Fibrinogen (congenital and acquired Fibrinogen deficiency)
  • Trimodulin (IgM Concentrate)
• Sales in Q1-Q3 2021: +8.7% compared to Q1-Q3 2020; Adjusted EBIT in Q1-Q3 2021: € 46.3 million
• Manufacturing licence granted for BNL (Biotest Next Level) facility
• Renate & Hans Schleussner Scientific Award for innovative research on (hyper)-immunoglobulins
• Guidance confirmed

Grifols S.A. – voluntary public takeover offer for all shares of Biotest AG

• On October 26, 2021 Grifols S.A. published a voluntary public takeover offer for all outstanding ordinary and preference shares of Biotest AG

Ordinary shares: Offer price: € 43.00 Preference Shares: Offer price: € 37.00

• In a "Joint reasoned statement" Supervisory Board and Management Board of Biotest AG recommend to accept the takevover offer by Grifols, S.A.
• Joint reasoned statement" has been published on November 5, 2021

Strategic considerations

• Providing a more complete range of plasma derived products
• Improved availability of life saving medicines by combining Biotest innovative pipeline and manufacturing capacities with existing Grifols activities
• Intention:

Intensify and accelerate Trimoduline and Fibrinogen development

Agreement CREAT – Grifols/ Grifols Offer Document

Situation with CREAT as major shareholder

Agreement Grifols – CREAT as of September 17, 2021

As a consequence of Grifols- CREAT Agreement:

• Grifols has published the "Offer Document" incl. assurances to keep name, headquarters' site and employees and to support our R&D projects and ramp-up of BNL
• Anti-trust/merger control filings in Germany, Spain, Austria, Turkey and UK
• Publication of "Joint Reasoned Statement" by Supervisory and Management Board of Biotest AG: offer is fair and acceptable
• After expiry of the acceptance period and after clearance by anti-trust authorities the settlement of the takeover offer will take place: Grifols will receive the shares and the (former) shareholders the purchase price

Timeline

Financials Q1-Q3 2021

Income statement (€ million)

	Q1-Q3 2020	Q1-Q3 2021
Sales	341.6	371.4
Therapy thereof:	303.7	329.8
Plasma & Services	33.8	36.3
Other Segments	4.1	5.3
Operating costs & expenses	-349.4	-382.6
Operating profit (EBIT)	-7.8	-11.2
Financial result, taxes	-24.0	-17.1
Earnings after tax (EAT) Biotest Group	-31.8	-28.3

Sales development of sales regions* (€ million)

*: In Q1 2021, Poland and the Czech Republic were reclassified from the Central Europe region to the Eastern Southern Europe region. The previous year's figures have been adjusted accordingly.

• Therapy sales up +8.6% to € 329.8 million in Q1-Q3 2021 vs. € 303.7 million in Q1-Q3 2020

• Segment Plasma & Services:

growth of +7.1% due to higher toll manufacturing (Middle East)

Reconciliation EBIT Q1-Q3 2020 – EBIT Q1-Q3 2021 (€ million)

	€ million*
EBIT Q1-Q3 2020	-7.8
Reduced Gross Profit (-11.4%)	-10.5
Lower Marketing & Distribution expenses	1.4
Lower Administrative expenses	0.8
Lower R&D expenses	1.3
Others (Other operating income and Other Oper. Expense)	3.6
EBIT Q1-Q3 2021	-11.2

*: a positive sign is favorable to EBIT, an negative sign is unfavorable to EBIT

EBIT reported and adjusted (€ million)

	Q1-Q3 2020	Q1-Q3 2021
EBIT reported	-7.8	-11.2
Biotest Next Level costs*	59.3	57.5
Monoclonal antibodies	0.1	0.0
EBIT adjusted	51.6	46.3

*: including R&D costs for BNL development projects

Biotest Next Level (BNL) costs in Q1-Q3 2021

1. BNL facility costs: € 27.7 million:

• Facility costs (energy, building costs, security, etc.)
• Depreciation
• Personnel costs (for ramp-up, commissioning etc.)
• Project administration

2. BNL R&D costs in total: € 29.3 million*; thereof:

• € 10.9 million IgG Next Generation
• € 12.9 million Trimodulin (IgM Concentrate)
• € 5.5 million Fibrinogen

Total BNL costs: € 57.5 million in Q1-Q3 2021

*: including external vendor cost (e.g. CRO) and internal cost of personnel and infrastructure

Reconciliation Financial Result Q1-Q3 2020 – Financial Result Q1-Q3 2021 (€ million)

	€ million
Financial Result, Taxes Q1-Q3 2020	-22.7
Variation in valuation of ADMA shares held by trustee	+2.5
Higher interest expenses	-2.6
Positive effect of FX / hedging	+6.3
Financial Result, Taxes Q1-Q3 2021	-16.5

Balance sheet (€ million)

Cash flow from operating activities January – September 2021 (€ million)

R&D update for BNL projects

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BNL: IgG Next Generation Overview

10% IVIg manufactured with a new production process, i.e. for highest quality product

IgG Next Generation is intended to become Biotest's world-wide IVIg with a focus on high price markets in EU, US market and RoW

Master product for the planned Biotest Next Level (BNL) production plant

• Increase in IgG yield to 4.5 g/l plasma
• Process suitable for manufacturing of IgG Next Generation and Trimoduline (IgM Concentrate)
• Optimization of product quality (e.g. low IgA and dimer content, low isoagglutinine content by additional column)

BNL: IgG Next Generation

Clinical development

• Phase III study in PID¹ (EU + US; study 991):
  • Treatment of adults and children completed
  • All clinical endpoints met
• Phase III study in ITP² (EU; study 992):
  • Treatment completed
  • Data shows expected good efficacy and a good safety profile of the product
• Phase III study for high dose indication (EU, US; study 999): Planned to be started in 2022
• Preparation of submission documents for Marketing Authorization ongoing
• Results in EU Clinical Trials Register published

¹ Primary Immune Deficiency; ² Idiopathic Thrombocytopenic Purpura

BNL: Fibrinogen Concentrate Overview

Abundant complex protein that can be purified from plasma and can be produced at competitive costs

Broad applications: For treatment of severe acute bleeding due to congenital and acquired fibrinogen deficiency

Targeted therapy and diagnostics: First coagulation factor deficient during acute blood loss

Growing demand expected

BNL: Fibrinogen Concentrate development for congenital and acquired fibrinogen deficiencies

Fibrinogen plays an essential role in blood clotting; a sufficient plasma fibrinogen level is critical for effective haemostasis

Phase I/III study fibrinogen deficiency:

• Congenital fibrinogen congenital deficiency is a very rare, inherited bleeding disorder in which the body's ability to form blood clots is impaired Phase I/III: completed

Phase III study acquired fibrinogen deficiency:

• In acquired fibrinogen deficiency body´s own coagulation factor fibrinogen is lost i.e. due to major bleeding
• Replacement of lost fibrinogen is critical to restore effective haemostasis
• Patients undergoing spinal surgery or tumor surgery (Pseudomyxoma peritonei) are treated with fibrinogen
• Phase III: ongoing

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BNL: Trimodulin Overview

Trimodulin is a new polyclonal antibody preparation with high content of IgM + IgA for treatment of

• Severe COVID-19 or
• Severe community acquired pneumonia (sCAP)
• Relevant upside potentials

Composition of product:

5% protein solution for infusion, approx. 23% IgM, 21% IgA, 56% IgG

Trimodulin acts via three potential mechanisms:

• 1) Targeting of the host inflammatory response
• 2) Opsonization (elimination) of causal pathogens
• 3) Neutralizing of microbial pathogens and their virulence factors

High medical need, high patient benefit and high commercial potential

ESsCOVID Design: Phase II trial with Trimodulin in COVID-19

Study objective

Demonstrate the efficacy and safety of trimodulin in severe hospitalized COVID-19 patients

France, Spain, Russia, Brazil
	15 active sites
	166 patients
Duration: FPI 06 OCT 2020 LPO 29 JUN 2021
	*FPI=First Patient In, LPO = Last Patient Out

Composite primary endpoint

• The clinical deterioration rate (score =6-7) between day 6 and day 29
• 28-day all-cause mortality rate (score =8) between day 1 and day 29

Patient statusg	Description . ¤	Score1x
Non-hospitalizedな	Discharged·,cured¤	Old
Non-hospitalized&	Discharged, limited activities, not returned to pre- disease-health-statusb	18
Hospitalizedn	Meets . discharge . criteria . defined . as . clinical . recovery . with-fever, respiratory rate - and-oxygen - saturation. returned to normal and with relief of cough and fatigue. ¶ Or hospitalized due to sequelae of COVID-19 infection of	20
Hospitalized, mild-disease¤	Not-requiring-supplemental-oxygen¤	30
	Requiring supplemental oxygen¤	4/2
Hospitalized, severe disease¤	On non - invasive - ventilation - (NIV) - or - high - flow - oxygen - devices, or both¤	50
Hospitalized, critical-disease¤	On· invasive· mechanical· ventilation· (IMV)· or- extracorporeal· membrane· oxygenation· (ECMO),· or· botha	64
	Respiratory. failure. with. MODS, . MOF, sepsis. and/or septic-shockp	70
Deathy	All-cause-mortality¤	80

ESsCOVID Phase II trial - Results

Study objective

Demonstrate the efficacy and safety of Trimodulin in severe hospitalized COVID-19 patients

Result

• Primary endpoint in total trial population (n=166) not met
• The good safety profile of Trimodulin was confirmed
• Relevant subgroup of hospitalized COVID-19 patients with early systemic inflammation (n=96) identified which benefitted from Trimodulin treatment
• Deterioration and 28-day mortality rate was 15% lower in Trimodulin treated patients compared to placebo.

Worsening / death

Trimodulin – Clinical development program Phase III

Caused by all kinds of pathogens (viruses, bacteria, fungi)

Caused by SARS-CoV-2

Paul-Ehrlich-Institut (PEI) recommended to continue COVID-19 development of Trimodulin in a phase III trial

Cytotect Phase III trial - prevent transmission of Cytomegalovirus infection

• Approval of Phase III clinical trial to prevent transmission of Cytomegalovirus (CMV) infection to the unborn child ("PreCyssion" - Prevention of maternal-foetal Cytomegalovirus transmission after primary maternal infection)

• Cytomegalovirus (CMV) infection of the foetus is one of the most common congenital infections and may cause severe developmental retardation, hearing loss and neurological late damage in new-borns
• High unmet medical need due to large amount of new-borns born with CMV-related disorders: In EU/ USA > 50,000 babies are born with CMV infection p.a. Currently, there is no approved therapy for this indication
• Significant reduction in CMV transmission from mother to foetus expected with treatment with CMV hyperimmunoglobulin
• With successfully completed trial, Biotest is seeking to extend the market authorisation for Cytotect CP Biotest®

Biotest Next Level update

Strategic pillars of BNL development program

• Capacity increase
• Globalisation of products
• More products out of one litre plasma
• Improved yield
• Specialty plasma products (high medical need)

Biotest AG

BNL achievements 2021 – IgG Next Generation

Next steps

Plasma collection

Expansion of plasma collection centers ongoing

Europe: 26 centres

• Four centres opened in 2021
  • Brno, Czech Republic Sopron, Hungary
  • Budweis, Czech Republik Szombathely, Hungary
• Expansion of plasma collection centres ongoing

Outlook 2021

Guidance 2021 confirmed

• Sales: Sales growth in mid-single-digit percentage
• EBIT: EBIT will be between € -5 and € -10 million

Earnings 2021 will be influenced by expected expenses of € 75 – 85 million due to BNL project incl. R&D costs, tense situation in the crisis regions as well as global impact of COVID-19 pandemic.

Financial Calendar 2022 and Contact

Financial Calendar 2021

• 30 Mar 2022 FY 2021
• 03 May 2022 Q1 Report
• 11 Aug 2022 H1 Report
• 14 Nov 2022 Q1-Q3 Report

Investor Relations Public Relations

Dr. Monika Buttkereit Dirk Neumüller Tel.: +49-6103-801-4406 Tel.: +49-6103-801-269 investor\_relations@biotest.de pr@biotest.com