Biotest AG

Company Presentation September 2019

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 figures reported relate to the Continuing Operations of the Biotest Group, if not specified otherwise. After the transfer of all US subsidiaries incl. our associate ADMA Biologics Inc., these activities are being reported as Discontinued Operations in the previous year.
All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest Group: H1 2019 at a glance

Guidance 2019 confirmed
Sales of Continuing Operations in H1 2019 at €195.1 m vs. €200.7 m in H1 2018
EBIT in H1 2019 at €-5.5 m vs. €0.6 m in H1 2018
Opening of two new plasma collection centres in Germany and Hungary; Total number to date 21
Approved indications of Intratect® in 22 European countries to include CIDP*, MMN**, as well as an extension in the area of secondary immunodeficiencies
Biotest Next Level project progressing

^*: Chronic Inflammatory Demyelinating Polyneuropathy; **: Multifocal Motor Neuropathy

CREAT Integration/ Financing of Biotest

Takeover became effective January 30, 2018
CREAT gave Shareholder Loan to Biotest for re-financing (€ 290 million)
Tiancheng International (holding company for Biotest and BPL) to be contributed/ integrated into Shanghai RAAS But: this was postponed till contribution of 45% of Grifols Diagnostic Services ("GDS") to Shanghai RAAS by Grifols S.A. will be effective
5 year financing agreement for a volume of €240 million completed in June 2019

CREAT – Shanghai RAAS – Grifols - GDS

% Current ownership

Ownership after the on-going deal between Shanghai RAAS and Grifols (%)

Grifols to take 26% stake in Shanghai RAAS in exchange for 45% in GDS (40% voting rights)
- − Grifols has received US anti-trust approval (15 May 2019)
Strategic plan for a multi-step consolidation of CREAT's existing plasma investments in Shanghai RAAS and Biotest

Income statement (€ million)

	H1 2018	H1 2019
Sales	200.7	195.1
Operating costs & expenses	-200.1	-200.6
Operating Profit (EBIT)	0.6	-5.5
Financial result, taxes	-8.6	7.5
Earnings after tax (EAT) from Continuing Operations	-8.0	2.0
Earnings after tax (EAT) from Discontinued Operations	193.7	-
Earnings after tax (EAT) Biotest Group	185.7	2.0

EBIT regular and adjusted (€ million)

	H1 2018	H1 2019
EBIT reported	0.6	-5.5
Biotest Next Level costs*	23.7	34.5
Monoclonal antibodies	2.5	0.9
EBIT adjusted	26.8	29.9

*: including R&D costs for BNL development drugs

Biotest Next Level (BNL) costs in H1 2019

1. BNL facility costs: € 13.8 million;

Facility costs (Energy, building costs, security, etc.)
Depreciation
Personnel costs (for ramp-up, commissioning etc.)
Project Administration
1. BNL R&D costs in total: € 20.7 million; thereof:
2. € 9.9 million IgG Next Generation
3. € 5.8 million Trimodulin (IgM Concentrate)
4. € 5.0 million Fibrinogen

Total BNL costs: € 34.5 million in H1 2019

Sales development

(€ million)

• Segment Plasma & Services: Decline in contract fractionation (Middle East), capacity used for own production

Balance sheet (Continuing + Discontinued Operations) (€ million)

Guidance 2019

Sales: In 2019 sales of continuing operations will increase by a mid-single-digit percentage

EBIT: Earnings will be influenced by various factors in 2019:
- Mainly further expenses as part of BNL expansion project of €80 to 90 million (incl. associated BNL R&D costs)
- Tense situation in the crisis regions, particularly in the Middle East
- A partner is being sought for advanced development projects

EBIT of continuing operations will be between €-5 m and € +5 m, if partnering can be successfully concluded in 2019

Strategy & Market environment

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

• The global IgG Market reached a size of nearly ~200 tons in 2018.

• In the period 2010 to 2018, the total market grew by ~8% annually (CAGR)

Sources: Biotest Market and Pricing Insights based on MRB (2016, 2017), PPTA (2018), Markets and Markets (2017), Allied Market Research 2018, Credit Suisse CSL US PPTA IG volume Jan 2019

Das ist der Biotest interner Forecast

Global total IgG (i.v. and s.c.) Geographical Volume Split – Development & Forecast

The global IgG Market reached ~200 tons in 2018 and is projected to reach > 300 t in 2023 at a CAGR (2017 – 2023) of 9%.
North America accounted for 47% of the market in 2018 and is estimated to reach 150 t by 2023

Sources: Biotest Market and Pricing Insights based on MRB (2016, 2017), PPTA (2018), Markets and Markets (2017), Allied Market Research 2018, Credit Suisse CSL US PPTA IG volume Jan 2019

IgG usage per capita 2017 Consumption

*IVIG usage per capita 2015

Source: IMS Midas (2017), PPTA (until Nov. 2017 for EU and Sep 2017 for US distribution data), MRB (2014, 2015, 2016), NBA Australia 2017, CIA Factbook, except *: populationpyramid.net

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

Immunoglobulines (IgG): Usage per capita in 2017 (kg per Mio. inhabitants; increase versus 2015 in %)

Quellen: IMS Midas (2017), PPTA (bis Nov. 2017 für EU- und Sep. 2017 für US-Vertriebsdaten), MRB (2014, 2015, 2016), NBA Australia 2017, CIA Factbook, außer *: populationpyramid.net

Immunoglobulines (IgGs): Further increase of global market volume expected

(Market volume in tons)

Biotest core business overview

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

Inventment into BNL

Product portfolio Biotest today / tomorrow

Today		Tomorrow
Polyvalent IgG Intratect 5% Intratect 10 %	+	Polyvalent IgG IgG Next Gen
Hyper – IgG/ Specialty products Hepatect (Hep B) Zutectra (Hep B) Fovepta (Hep B) Cytotect (Cytomegalie) Varitect (Varizella-Zoster)
Specialty products Pentaglobin (IgM enriched IgG) Biseko	+	Specialty products Trimodulin (IgM enriched IgG)
Haemophilia Haemoctin (FVIII) Haemonine (FIX)	+	Fibrinogen Acquired Fibrinogen def. Congenital Fibrionogen def.
Human Albumin Albiomin 5 % Albiomin 20%

Biotest portfolio differentiation (€ million)

Biotest has unique speciality products in it´s portfolio:

Cytotect
Varitect
Hepatect
Zutectra
Pentaglobin (IgM product)
Biseko
Speciality portfolio show good growth rates

Expansion of plasma donation centres

Two new centres in Czech Republic (Břeclav, Brno) in 2018
One new centre in Germany (Hanover) and one in Budapest (Hungary) in 2019

New plasma donation centre in Brno

Biotest plasma donation centres

Research & Development projects

Strategic pillars of BNL development program

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

Everything Needs to Work Smoothly Together

Research & development projects to market

Today	2021	>2021
• BNL product development	• IgG Next Generation  PID*	• IgG Next Generation  Subcutaneous (SC)
• Life cycle	 ITP**	 Dermatology
management projects	• Albiomin	• Trimodulin (IgM Con.)
	• Haemoctin	• Fibrinogen  congenital
		 acquired

• Haemophilia A Therapeutic

IgG Next Generation (IVIG)

• New efficient production process with high IgG yield established

• Phase III study in ITP** (EU; study 992): study completed

• "Master product" for the Biotest Next Level production plant

Clinical development

Phase III study in PID* (EU + US; study 991): enrollment completed, treatment for children ongoing
-
- - *: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura

IgG Next Generation (BT595)

10% IVIg manufactured with a new production process

Development of a subcutaneous (SC) product (20%) has started

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

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

IgG Next Generation – Development Strategy

Increase in IgG yield by 0.5 g/l plasma to 4.5 g/l plasma
Process suitable for manufacturing of IgG Next Generation and IgM Concentrate/Trimodulin
Increase attractiveness by an state of the art SC product and approval of additional indication(s) as life cycle management
One product suitable for worldwide commercialization
Optimization of product quality (e.g. low IgA and dimer content)

Building on the Intratect experience to create an optimized IVIG IgG Next Generation

Maintain:

No thrombogenic activity
Infusion rate up to 8 ml/kg/h with flexible infusion protocols
Low ACA & polymer levels
High margins of safety for prions and viruses

Further improve:

Implementation of an additional purification column to further reduce anti-A/anti-B antibody levels
Increased immunoglobulin yield to 4.5 g/l plasma

Fibrinogen

Indication:

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

Status:

Congenital Fibrinogen deficiency trail in phase I/III
Acquired Fibrinogen deficiency in phase III

Source: IMS Data 2-2017, Internal Critical bleeding market research, Data provided by affiliate

Fibrinogen - Point of care diagnostic

In Germany and Austria the market growth was highly connected with improved diagnostics
ROTEM®/TEG® devices are established for point-of-care diagnosis and treatment
Especially important for acquired fibrinogen deficiency,
- to monitor decrease of fibrinogen levels during bleeding => triggered treatment decision
- to adjust dosing according to individual need => targeted dosing

Trimodulin - IgM-enriched Immunoglobulin Broad therapeutic potential in severe infection

i.e. K. pneumoniae, P. mirabilis, P. aeruginosa, E. sakazakii, Enterococcus sp., Staph. aureus, C. difficile, C. jejuni, C.albicans, E. coli, P. aeruginosa, S. marcescens, Enterobacter sakazakii

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

Trimodulin for treatment of severe community acquired pneumonia (sCAP)

No comparable adjuvant therapy available

Neutralization of bacterial toxins
Reduction of overshooting immune-mediated tissue damage
Reduced risk for severe sepsis, septic shock, respiratory and multiorgan failure

Competitor Mapping

No direct competitors no IgM enriched immunoglobulins on the market or in clinical trials
High medical need mortality rate high despite antibiotics
Commercial advantageous pricing opportunity

Trimodulin – Upside Indications

Biotest Next Level: Progress in Dreieich

Equipment for the purification of IgG Next Generation handed over to Biotest
Technologically leading system for virus inactivation integrated
Qualifications of clean rooms and media systems are in progress to be approved by Darmstadt Regional Council in Q4/2019
Establishment and validation of manufacturing processes is ongoing to be approved in 2020

Summary

Next Steps

Biotest Next Level progressing
Clinical trials for new BNL products ongoing: IgG Next Gen, Fibrinogen; Trimodulin in preparation
Opening of new plasma collection centres in Europe

Financial Calendar 2019

14 Nov 2019 Q1-Q3 Report 2019 30 Mar 2020 FY Report 2019 05 May 2020 Q1 Report 2020

Investor Relations Dr. Monika Buttkereit

Tel.: +49-6103-801-4406 investor\[email protected]

Public Relations Dirk Neumüller

Tel.: +49-6103-801-269 [email protected]