Biotest AG

FY 2021 Results Conference call

March 24, 2022

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 FY 2021

Biotest Group – Overview FY 2021

Voluntary takeover offer by Grifols, S.A.: almost completed
Expansion of EU plasma collection centres continued: now 29 centres
R&D pipeline projects are progressing
German Federal Ministry of Education and Research (BMBF) and German Federal Ministry of Health (BMG) awarded Biotest's Trimodulin project with financial support in the volume of up to € 29 million
Sales FY 2021: € 515.6 million, +6.5% compared to FY 2020; Adjusted EBIT FY 2021: € 29.4 million after one-time write-off of € 40.1 million
Manufacturing licence granted for Biotest Next Level facility in July 2021
New Management Board member Dr. Jörg Schüttrumpf (CSO) appointed

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

Grifols S.A. voluntary public takeover ongoing:

Status as of Jan 21, 2022:

6.22% outstanding ordinary shares and 42.24% outstanding preference shares were tendered
After closing, Grifols S.A. will own 96.2% ordinary shares and 43.2% preference shares
Anti-trust/merger control filings settled in Austria, Germany, Spain; ongoing in Turkey
Closing expected within the next weeks
Squeeze out for ordinary shares planned

5 Biotest AG

Current Status CREAT - Grifols – Biotest - as of Jan 21, 2022

Strategic considerations for Grifols S.A. takeover of Biotest

Providing a more complete range of plasma derived products of both companies
Improved availability of life saving medicines by combining Biotest innovative pipeline and manufacturing capacities with existing Grifols activities
Intention: Intensify and accelerate Biotest´s Trimodulin and Fibrinogen development

Biotest COVID-19 update

Biotest has managed well the COVID-19 situation so far
Antigen tests introduced for employees in late 2020
1 st & 2nd vaccination offered to employees starting in June 2021
Booster vaccination offer from December 2021 onwards
Little quarantine was experienced during the past 2 years
Current absenteeism among employees like severe flu

Corona vaccination activities

Biotest – Sustainability Report 2021

Can anything be more sustainable than ensuring and protecting not only the basis of life of future generations, but already this of today?

based on products made from renewable raw materials
with low environmental impact and
climate-neutral production (Scope 1 and 2)
due to the switch to green electricity and
voluntary compensation measures for all greenhouse gas emissions

Report on the EU Taxonomy Regulation

Income statement (€ million)

	FY 2020	FY 2021	FY 2021 w/o FVIII one-time effect
Sales	484.2	515.6	515.6
Therapy thereof:	430.5	461.6
Plasma & Services	46.7	46.7
Other Segments	7.0	7.3
Operating costs & expenses	-485.5	-562.7	-522.6
Operating profit (EBIT)	-1.3	-47.1	-7.0
Financial result, result from joint ventures, taxes	-30.1	-16.3	-16.3
Earnings after tax (EAT) Biotest Group	-31.4	-63.4	-23.3

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 +7.2% to € 461.6.8 million in FY 2021 vs. € 430.5 million in FY 2020

Reconciliation EBIT FY 2020 – EBIT FY 2021 (€ million)

	€ million*	FY 2021 w/o FVIII one-time effect
EBIT FY 2020	-1.3	-1.3
Reduced Gross Profit (-38.0%)	-49.5	-9.4
Higher Marketing & Distribution expenses	-0.9	-0.9
Higher Administrative expenses	-1.9	-1.9
Lower R&D expenses	3.6	3.6
Others (Other operating income and Other Oper. Expense)	2.9	2.9
EBIT FY 2021	-47.1	-7.0

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

EBIT reported and adjusted (€ million)

	FY 2020	FY 2021	FY 2021 w/o FVIII one-time effect
EBIT reported	-1.3	-47.1	-7.0
Biotest Next Level costs*	79.6	76.5	76.5
Monoclonal antibodies	0.1	0.0	0.0
EBIT adjusted	78.4	29.4	69.5

*: including R&D costs for BNL development projects

Biotest Next Level (BNL) costs in FY 2021

1. BNL facility costs: € 38.3 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: € 37.5 million*; thereof:

€ 13.5 million IgG Next Generation
€ 16.6 million Trimodulin (IgM Concentrate)
€ 7.4 million Fibrinogen

Total BNL costs: € 76.5 million in FY 2021

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

Reconciliation Financial Result FY 2020 – Financial Result FY 2021 (€ million)

	€ million
Financial Result FY 2020	-28.2
Variation in valuation of ADMA shares held by trustee	+5.4
Higher interest expenses	-0,1
Positive effect of FX / hedging	+6.1
Financial Result FY 2021	-16.8

Balance sheet (€ million)

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

R&D Opportunities - Biotest with Grifols

1. Grifols to be new major shareholder
1. New strategic options for R&D developments with significant increase of market expectations due to complementary expertise and strengths
1. Wider commercial reach
1. Acceleration of R&D projects with higher R&D spending

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
Results in EU Clinical Trials Register published
Preparation of submission documents for Marketing Authorization for spring 2022

¹ Primary Immune Deficiency; ² Idiopathic Thrombocytopenic Purpura

BNL: Fibrinogen Concentrate -

development for congenital and acquired fibrinogen deficiencies

Phase I/III study fibrinogen deficiency:

• Congenital fibrinogen 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

Trimodulin – Clinical development program Phase III

Paul-Ehrlich-Institut (PEI) recommended to continue COVID-19 development of Trimodulin in a phase III trial
TRICOVID development is supported by a € 29 million grant by the German Government

Trimodulin Status update

In both phase II clinical trials, the ESsCOVID trial for COVID-19 and the CIGMA trial for severe Community Acquired Pneumonia (sCAP) Biotest identified patient populations that markedly benefited from treatment with Trimodulin compared to placebo treated patients
The Phase III program for Trimodulin will start with two trials in 2022:
a) TRICOVID trial targeting hospitalized COVID-19 patients: First study, preparation ongoing
b) ESsCAPE trial targeting patients with sCAP: Second study, preparation ongoing

Biotest Next Level update

BNL achievements 2021 – IgG Next Generation

BNL Update

The last Process Performance Qualification (PPQ) batch was manufactured in August 2021; herewith all prerequisites for successful commercial production of IgG Next Generation have been established
All data collected will be compiled as part of preparing the dossier; submission of the dossier to the competent authorities planned for spring 2022
Approval/ marketing authorization for IgG Next Generation is expected at the end of 2022
Start of validation & commissioning of Trimodulin and Fibrinogen plant

Next Steps

Ramp-up IgG Next Generation

Expansion of plasma collection centers ongoing – now 29 centres

Five centres opened in 2021 Two centres opened in Jan and Mar 2022

Czech Republic:
Brno
Budweis
Strakonice
Kolin
Ostrava
Hungary:
Sopron
Szombathely

Expansion of plasma collection centres ongoing

Cara Plasma, Strakonice, Czech Republic – 11/ 2021 PDU, Sopron, Hungary – 7/ 2021

Impact of COVID-19 on US and EU Commercial Plasma Collections

Strong and persisting impact of COVID-19 on US source plasma collections in 2021; >60% of global plasma for fractionation collected in the US
EU (DE, HU, CZ, AT) collections less impacted and recovering faster, but with minor share of global plasma supply
Global shortage of plasma and, consequently, shortage of IgG ongoing in 2022

Source: PPTA, Biotest internal analysis; charts not to scale

Forecasting capability for 2022 impaired by

Weakening of the economy expected due to Russian Ukraine war
Strong increase of energy costs: gas, electricity, oil etc. > 20%
Significant increase of costs for other operational materials and supplies > 15%
Supply difficulties expected: i.e. for Ethanol (alcohol), plasma and other operating materials
Increased operational risks due to prolonged delivery times (spare parts, filters etc.)
COVID-19 related staff shortages
Potential production interruption

Guidance 2022: Sales & Risks

Sales

No general demand or medical need issue

But:

Overall economic situation may reduce "purchase power" of health systems

More risky:

Production slow down or interruption
COVID-19 induced staff shortage
Delayed delivery of plasma
Postponed inspections of new plasma centers
Limited availability of spare parts, important supplies
Energy shortages

Guidance 2022

Financial Calendar 2022 and Contact

Financial Calendar 2022

05 May 2022 Q1 Report
05 May 2022 AGM
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 [email protected] [email protected]