Biotest AG — Investor Presentation 2020

Aug 13, 2020

Biotest AG

Company Presentation H1 2020 August 2020

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.

Biotest Group: H1 2020 at a glance

• Sales increase of +20.3% to €234.8 m in H1 2020 vs. €195.1 m in H1 2019
• EBIT in H1 2020 at € 0.7 m vs. € -5.5 m in H1 2019
• Adjusted EBIT increased to € 41.1 m in H1 2020 vs. € 29.9 m in H1 2019
• First Albumin sales in China
• Two development projects regarding a therapy for COVID-19 infection started
• Biotest Next Level project progressing; second approval by the Darmstadt Regional Council in mid-June 2020

Corona Virus Special

Biotest products are safe!

• FDA (August 2020): No case of corona virus transmission via blood transfusion has been reported
• Biotest: persons with diagnosed corona virus infection are not permitted to donate plasma
• Biotest manufacturing process: four processing steps for virus inactivation and virus elimination

Manufacturing process ensures inactivation of viruses

• Treatment with octanoic acid
• Use of detergents
• Heat treatment
• Nanofiltration

Virus removal by nanofiltration

• Plasma protein solution must pass an only 20 nanometers wide filter opening
• Viruses with a larger diameter are filtered out
• Ø corona virus: >120 nanometers

Protection for plasma donors and Biotest staff

• Protection of plasma donors

• Complying with distance rules with respect to donation beds
• Donations by appointment only: only a few donors present in center, distance rules in waiting area
• Protection of staff ensuring uninterrupted business operations
• Working remotely
• Additional measures in terms of hygiene and distancing
• Own production of hand disinfectant
• Biotest is systemically relevant, emergency day care for children of staff members possible

1. Use of "convalescent" plasma (Biotest Germany, Hungary collect plasma)

2. Development of a new Hyperimmunoglobulin

3. Trimodulin (IgM immunoglobulin concentrate)

• a) Submission of a phase II study (ESsCOVID study) exclusively in severe COVID-19 patients to competent authority

• b) COVID-19 will be considered in the design of the phase III ESsCAPE study

• Plasma collected from cured corona virus patients (convalescent plasma) is directly used for therapy for patients suffering from COVID-19

• "Convalescent" approach pursued in numerous countries
• In Hungary, the Biotest plasma collection centre at Budapest collects plasma of cured COVID-19 patients in parallel to regular operations by special request of the Health Ministry of Hungary

2. Development of new drug: COVID-19 Hyperimmunoglobulin

• Entirely new drug: COVID-19 Hyperimmunoglobulin
• Use of plasma donations containing COVID-19 antibodies
• Biotest collects plasma containing COVID-19 antibodies in Hungary and Germany
• Processing into new hyperimmunoglobulin against COVID-19
• Global cooperation with BPL, CSL, LFB, Octapharma, and Takeda amongst others in "CoVIg-19 PLASMA ALLIANCES"

With optimal project progress, drug available end of 2020 at the earliest

• 1. Trimodulin: potential for COVID-19 infection

• Trimodulin was used in a phase II CIGMA study in severe pneumonia (in addition to standard therapy and intensive care)

• 50-70% reduction of mortality in patients with high inflammation and/or compromised immune system

• Striking similarity of COVID-19 clinical picture to this patient group in CIGMA study

Trimodulin: mode-of-action in sCAP (incl. COVID-19)

Trimodulin in COVID-19

• ESsCOVID (Escape from severe COVID-19) phase II study exclusively in severe Covid-19 patients was submitted to Competent Authority and responsible Ethics Committee; study planned in Spain, Brazil and Russia
• Multinational phase II clinical trial with approx.160 adult patients to be enrolled; Biotest targets an accelerated approval
• To offer a fast response during the current outbreak and have a possibility to shorten the time-to-market
• Design of phase III ESsCAPE study in sCAP, also accounting for COVID-19 patients in preparation
• The goal is to obtain a broad indication in sCAP including COVID-19

Financials H1 2020

	H1 2019	H1 2020
Sales	195.1	234.8
Operating costs & expenses	-200.6	-234.1
Operating Profit (EBIT)	-5.5	0.7
Financial result, taxes	7.5	-17.4
Earnings after tax (EAT) Biotest Group	2.0	-16.7

EBIT regular and adjusted (€ million)

	H1 2019	H1 2020
EBIT reported	-5.5	0.7
Biotest Next Level costs*	34.5	40.3
Monoclonal antibodies	0.9	0.1
EBIT adjusted	29.9	41.1

*: including R&D costs for BNL development drugs

Biotest Next Level (BNL) costs in H1 2020

• Facility costs (Energy, building costs, security, etc.)
• Depreciation
• Personnel costs (for ramp-up, commissioning etc.)
• Project Administration
• 1. BNL R&D costs in total: € 21.0 million; thereof:
• € 8.5 million IgG Next Generation
• € 7.7 million Trimodulin (IgM Concentrate)
• € 4.8 million Fibrinogen

Total BNL costs: € 40.3 million in H1 2020

Sales development (€ million)

• The sales increase of € 39.7 million resulted in particular from increased sales volumes and higher selling prices for Intratect® and Human Albumin as well as from significantly higher toll manufacturing

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Balance sheet (€ million)

Sales: In 2020 sales will increase by 10 percent

EBIT: Earnings will be influenced by various factors in 2020:

• Mainly further BNL expenses (€80 90 million)
• Tense situation in the crisis regions, particularly in the Middle East and Asia

EBIT of continuing operations will be between €-10 m and €-5 m. Due to two new COVID-19 development projects, management expects earnings to be at the lower end of the range given

* Caveat: Guidance is given without any expected, but not yet assessable negative impact of the Corona virus crisis!

Market environment & product portfolio

Global IgG (i.v. and s.c.) Market Size Development

• The global IgG Market reached a size of nearly ~220 tons in 2019.

• In the period 2011 to 2019, the total market grew by ~9% annually (CAGR)

Sources: Biotest Market and Pricing Insights based on MRB (2018, 2019), PPTA (2020), Markets and Markets (2019), Allied Market Research 2018

Global IgG Market – usage per capita 2018

Sources: Iqvia (2018), PPTA (2018 for EU and USA estimation based on CSL Analyst report May 2019), MRB (2014, 2015, 2016, 2017), NBA Australia 2018, CIA Factbook, except * populationpyramid.net

Immunoglobulins (IgGs) – Forecast to 2024

(Market volume in tons)

• The global IgG market is projected to reach > 330 t in 2024 at a CAGR (2018 – 2024) of 9%.

• North America accounted for a share of 47% in 2018 and is estimated to reach 155 t by 2024 from approximately 96 t in 2018, at a CAGR (2018 – 2024) of 8%.

MPI based on MRB (2018, 2019), PPTA (2020), Markets and Markets (2019); Morgan Stanley May 2020, " A collection of sensitives"; Morgan Stanley June 2020 "Global Plasma Tracker"

Biotest core business overview

Biotest is a vertically integrated business, from plasma collection through production and distribution

Biotest Product Portfolio Overview

Biotest produces and sells biological medicinal products in three therapeutical areas, that are either obtained from human plasma or manufactured using biotechnological methods

Clinical Immunology Disorders of the immune system	Haematology Diseases of the blood and blood-forming system	Intensive Care Medicine Acute, mostly life threatening diseases
Intratect® Hepatect® Zutectra®, Fovepta® Cytotect® Varitect®	Haemoctin® Haemonine® Vihuma ®	Pentaglobin® Human Albumin Biseko® Cofact®

Clinical Immunology

*: HSCT = hematopoietic stem cell transplantation

Biotest offers a broad portfolio of high quality Hepatitis B Immunoglobulins (HBIG)

Hepatect®CP Zutectra® Fovepta®

• Good safety profile (no nephrotoxicity) and quality formulation (no sucrose)
• Broad indications
• Various sizes
• Ready to use
• Approved since 1982

• Authorized: 42 countries

• Convenient (ready to use, easy to use, and early use 1 week after Liver Transplantation)

• Only SC HBIG in the market
• Less painful form of administration (compared to IM)
• Provides high quality of life (compare TWINSII study)
• Approved since 2009

• Authorized: 38 countries

• Only subcutaneous Hepatitis B immunoglobulin for newborns

• Low volume
• Ready to use
• Less painful (compared to i.m./ i.v.)
• Approved since 2012
• Authorized in 10 countries

Haematology

Intensive Care Medicine

Investment into BNL – strategic development

Product portfolio Biotest today / tomorrow

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+

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Polyvalent IgG

Intratect 5% Intratect 10 %

Hyper – IgG/ Specialty products

Hepatect (Hep B) Zutectra (Hep B) Fovepta (Hep B) Cytotect (Cytomegaly) Varitect (Varicella-Zoster)

Specialty products

Pentaglobin (IgM enriched IgG) Cofact

Haemophilia

Haemoctin (FVIII) Haemonine (FIX)

Human Albumin

Albiomin 5 % Albiomin 20%

Tomorrow

• Polyvalent IgG IgG Next Gen
• Covid-19 Hyper-Immunoglobulin

Specialty products Trimodulin (IgM enriched IgG)

Fibrinogen Acquired Fibrinogen deficiency Congenital Fibrionogen deficiency +

Research & Development

Strategic pillars of BNL development program

• Globalization of products
• More products out of one litre plasma
• Specialty plasma products (high medical need)

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Research & development projects to market

2020	2021	>2021
• Albumin China MRP1 • Cytotect	• IgG Next Generation PID2  ITP3 	• IgG Next Generation  Subcutaneous (SC)  Dermatology
	• Trimodulin (IgM Con.)  Esscovid study	• Trimodulin (IgM Con.) sCAP4 
	• Albiomin (BNL) • Haemoctin (BNL)	• Fibrinogen  congenital  acquired
	1: Mutual Recognition Procedure; 2: Primary Immune Deficiency;	• Haemophilia A Therapeutic

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3: Idiopathic Thrombocytopenic Purpura; 4: severe Community acquired Pneumonia

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IgG Next Generation (IVIG, 10%)

• New efficient production process of the "IgG Next Generation" immunoglobulin with high IgG yield established
• One product suitable for worldwide commercialization
• "Master product" for the Biotest Next Level production plant

Clinical development

• Phase III study in PID* (EU + US; study 991):
• Treatment of adults and children completed
• Evaluation of the study has begun
• Phase III study in ITP** (EU; study 992):
• - Treatment of adults and children completed
• Data shows expected good efficacy and a good safety profile of the product

*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura

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Fibrinogen

Indication

Congenital fibrinogen deficiency and acquired fibrinogen deficiency in the indication severe spinal surgery

Clinical development

• Phase I/ III study (study No. 984) in congenital fibrinogen deficiency:
• Largest clinical trial in congenital fibrinogen deficiency worldwide
• Data analysis currently underway
• Initial results confirm high expectations regarding efficacy and safety
• Final results expected end of Q4 2020
• Phase III study ( study No. 995) in acquired fibrinogen deficiency:
• - Recruitment ongoing
• The ADFIRST study is a prospective, active-controlled, multicenter phase III study in patients who have a high blood loss during elective spinal surgery and Pseudomyxoma peritonei (PMP, tumor)

Trimodulin – IgM-enriched Immunoglobulin

• Neutralization of multiple pathogens
• Binding of toxins and inflammation activators
• Reducing the secretion of immune mediators
• Immune modulation

• Broad therapeutic potential in severe infection

Clinical development

• Phase II "ESsCOVID" study for treatment of patients with severe COVID-19 pneumonia:

• Study has been submitted to Competent authority and ethics commission

• Phase III study "ESsCAPE" and pediatric development plan in sCAP, also accounting for COVID-19 patients:

• Coordination with the US Food and Drug Administration (FDA), EMA and Paul Ehrlich Institute has taken place; phase III study and pediatric development plan in preparation

Plasma Donation and Plasma Centres

Expansion of plasma collection centres

Europe: 22 centres

• Last centres opened in
• Hanover, Germany
• Budapest, Hungary
• Jihlava, Czech Republik
• Expansion of plasma centres ongoing

Plasma is needed!!!

…more urgent than ever….!!!

• .....particularly in Corona virus times
• Biotest Plasma centres are open in Germany, Hungary and Czech Republic
• Worldwide, millions of people need medicines made from plasma, where no other treatment option exists

Biotest Next Level

Biotest Next Level

Entire Biotest area

New BNL production site

BNL 2019

• Clean rooms and media systems are operated under full GMP conditions

BNL 2020 – Successful second inspection of BNL production plant passed

2 nd Inspection of the infrastructure by Darmstadt Regional Council

Period: 23-25. June 2020 Purpose: Inspection of GMP requirements as part of the manufacturing license Authority: Regional council Darmstadt, Germany

Scope:

Qualification of the actual product-carrying production equipment for the IgG Next Gen process as well as in-process laboratories

Result:

no Critical; no Major; only two Minor findings were recorded. => 2 further inspections in 2020/21 to be conducted

Implementation of manufacturing process continues...

1 st full scale, overall (Plasma => Drug Substance) Engineering Run completed

=> Further Engineering and Validation Runs are in progress

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Summary

Next Steps

• Biotest Next Level progressing
• Clinical trials for new BNL products ongoing: IgG Next Gen, Fibrinogen and Trimodulin
• Two development projects regarding a therapy for COVID-19 infection started
• Opening of new plasma collection centres in Europe

Financial Calendar 2020 Contact

Financial Calendar 2020

12 Nov 2020 Q3 Report 2020

11 May 2021 Annual General Meeting

Investor Relations

Dr. Monika Buttkereit

Tel.: +49-6103-801-4406 investor\_relations@biotest.de

Public Relations Dirk Neumüller

Tel.: +49-6103-801-269 pr@biotest.com