Biotest AG — Interim / Quarterly Report 2021

Aug 12, 2021

Biotest AG

Half year results 2021

12 August, 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 H1 2021

Biotest Group

• Founded 1946, IPO 1987
• 1,963 FTE's
• 8 Affiliates in Europe and Brazil

• 25 Plasma Collection Centres in GER, HU and CZ

• Management Board: 2 members (m); Supervisory Board: 6 members (4 m; 2 f)

• H1 2021 Sales: +9.8% compared to H1 2020; H1 2021 adjusted EBIT: € 29.5 million

Financials H1 2021

Income statement (€ million)

	H1 2020	H1 2021
Sales	234.8	257.8
Therapy thereof:	207.4	224.1
Plasma & Services	24.9	29.9
Other Segments	2.5	3.8
Operating costs & expenses	-234.1	-266.4
Operating profit (EBIT)	0.7	-8.6
Financial result, taxes	-17.4	-9.6
Earnings after tax (EAT) Biotest Group	-16.7	-18.2

Sales development of sales regions (€ million)

• Therapy sales up +8.1% to € 224.1 million in H1 2021 vs. € 207.4 million in H1 2020

• Segment Plasma & Services: growth of +20.1% due to significantly higher toll manufacturing (Middle East)

	€ million*
EBIT H1 2020	0.7
Change in Gross Profit (-15.3%)	-10.1
Change in Marketing & Distribution expenses (-0.4%)	0.1
Change in Administrative expenses (-10.2%)	1.7
Change in R&D expenses (-2.6%)	0.8
Change in OOI and OOE (-63%)	-1.7
EBIT H1 2021	-8.5

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

EBIT reported and adjusted (€ million)

	H1 2020	H1 2021
EBIT reported	0.7	-8.5
Biotest Next Level costs*	40.3	38.0
Monoclonal antibodies	0.1	0.0
EBIT adjusted	41.1	29.5

*: including R&D costs for BNL development projects

Biotest Next Level (BNL) costs in H1 2021

1. BNL facility costs: € 18.8 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: € 19.2 million; thereof:

• € 6.7 million IgG Next Generation
• € 9.3 million Trimodulin (IgM Concentrate)
• € 3.2 million Fibrinogen

Total BNL costs: € 38.0 million in H1 2021

Reconciliation Financial Result H1 2020 – Financial Result H1 2021 (€ million)

	€ million
Financial Result, Taxes H1 2020	-16.3
Variation in valuation of ADMA shares held by trustee	+2.4
Higher interest expenses	-1.2
Higher FX / hedging costs	+6.8
Other	-0.9
Financial Result, Taxes H1 2021	-9.2

Balance sheet (€ million)

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

R&D update for BNL projects

Dritte Zeile

BNL: IgG Next Generation

• Immunoglobulin "IgG Next Generation" for patients with immune system dysfunctions and autoimmune disorders

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
• First virtual Investigator meeting held with positive feedback on efficacy and safety data by investigators
• Abstracts planed in parallel to submission

¹ Primary Immune Deficiency; ² Idiopathic Thrombocytopenic Purpura

BNL: Fibrinogen - 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 congenital 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
• Spinal surgery and Pseudomyxoma peritonei (tumor surgery) have been postponed due to Corona

Phase III: ongoing

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1 : Community acquired Pneumonia ² : Acute Respiratory Distress Syndrome ³ : C-Reactive Protein ⁴ : Clinical Trial Application

• Strong medical rationale for Trimodulin (IgM/IgA Concentrate)

• 50-70% reduction of mortality in similar patient population: Mechanically ventilated patients with severe Community Acquired Pneumonia (sCAP) and high inflammation markers and/or low IgM levels
• Convincing mode-of-action in COVID-19 in vitro at the very front of the competitors

• Phase II study: "ESsCOVID" (Escape from severe COVID-19)

• Multinational phase II clinical trial with 166 adult patients
• Patients with confirmed severe COVID-19 disease with CAP¹ or ARDS² , receiving non-invasive ventilated (NIV) or high oxygen therapy; signs of inflammation: CRP³ >50 mg/mL

Work package	Start
Submission CTA4	Jul 2020 
First-patient-in	Oct 2020 
Last-patient-out	Q2 2021 
Clinical study report ready for submission	Q3 2021
First sales	Q1 2022*

*Depending on study outcome and acceleration options

Design of phase III "ESsCAPE" study and pediatric development plan in sCAP, also accounting for COVID-19 patients:

• Start of study after phase II "ESsCOVID" study, depending on the outcome of this study
• Coordination with US Food and Drug Administration (FDA), EMA and Paul Ehrlich Institute has taken place
• Phase III study preparation ongoing
• The goal is to obtain a broad indication in sCAP including COVID-19

BNL: Trimodulin – commercial aspects

COVID-19 and severe Community Acquired Pneumonia (sCAP)

• 80 000 patients/year in initial target population already exceeds current manufacturing capacity

• Market size in sCAP alone approx. 350,000 patients worldwide¹
• Sales potential min. €300 million p.a.
• Good clinical outcomes (mortality reduction) can further drive value
• Significant upside due to higher price depends on data of clinical trials

Several upside indications

Biotest receives manufacturing license for new production facility

• Final inspection by the Darmstadt Regional Council and the Paul Ehrlich Institute successfully completed
• As a result, the manufacturing license was granted in accordance with §13 AMG (German Medicines Act)
• The final steps for the market approval of our new IgG Next Generation immunoglobulin still need to be completed
• Beginning of 2022, Biotest will apply for approval at the Paul Ehrlich Institute with the data of the first, currently produced batches and subsequently ramp up production in parallel
• Start of routine production and ramp-up of the plants is initiated

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Strategic pillars of BNL development program

• Capacity increase
• Globalisation of products
• More products out of one litre plasma

Today F VIII Albumin IgG

• Improved yield

BNL

• Specialty plasma products (high medical need)

22

F VIII Albumin IgG Trimodulin Fibrinogen

BNL – IgG Next Generation

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.

Summary

• H1 2021 showed a 10% revenue increase despite the pandemic
• The pandemic will stimulate and motivate us: we will rather be encouraged by chances than frightened by the challenges
• We trust that Trimodulin will become a helpful therapy for severe COVID-19 patients clinical trial results expected in August 2021
• We will continue to increase the number of our European plasma collection centers

Financial Calendar 2021/ 2022 and Contact

Financial Calendar 2021

• 11 Nov 2021 Q1-Q3 Report
• 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