Biotest AGCompany 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.

2Company Presentation Biotest AG

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

3Company Presentation Biotest AG

*: 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

Company Presentation Biotest AG 4

CREAT – Shanghai RAAS – Grifols - GDS

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

Current ownership%

(%)

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

Grifols

Diagnostics Solutions

“GDS”

Shanghai RAAS

(Mkt cap: €5.2bn)

CREAT

TianchengRAAS China

Grifols S.A.

(Mkt cap: €14.4bn)

34.9% 36.2%

100%

(26.2%) (25.8%) (26.7%)

(45.0%)

(89.88% ordinary + 1.08% pref.)(55.0%)

BPL

Free float

100%

(10.12% ordinary + 98.92% pref.)

Company Presentation Biotest AG 5

Financials H1 2019

Income statement(€ million)

H1 2018 H1 2019

Sales 200.7 195.1

Operating costs & expenses -200.1

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

Company Presentation 7Biotest AG

-200.6

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

Company Presentation 8Biotest AG

EBIT regular and adjusted(€ million)

*: 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

2. BNL R&D costs in total: € 20.7 million; thereof:- € 9.9 million - IgG Next Generation

- € 5.8 million - Trimodulin (IgM Concentrate)

- € 5.0 million - Fibrinogen

Total BNL costs: € 34.5 million in H1 2019

9Biotest AGCompany Presentation

0

50

100

150

200

250

H1 2018 H1 2019

Sales development(€ million)

10

200.7195.1

-2.8%

Central

Europe

East & South

Europe

Inter-

continental

Middle East,

Africa &

France

35.1

44.8

41.8

32.4

54.6

36.6

74.4 76.1

Company Presentation Biotest AG

• Segment Plasma & Services:

Decline in contract fractionation

(Middle East), capacity used for

own production

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

0

200

400

600

800

1.000

Current assets

Non-currentassets

11

1,058.21,042.3

31 Dec 2018

Assets Equity and Liabilities Equity ratio

30 June 2019:

46.9%1,058.2

496.2

415.6

421.5

495.2569.6

488.6495.1

547.2

146.4

125.6

Company Presentation Biotest AG

1,042.3

30 Jun 2019 31 Dec 2018 30 Jun 2019

Current assets

Non-current assets

Current liabilities

Non-current liabilities

Equity

1,000

800

600

400

200

0

Solid equity ratio

of 46.9%

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

Company Presentation 12Biotest AG

EBIT of continuing operations will be between €-5 m and

€ +5 m, if partnering can be successfully concluded in 2019

Strategy &

Market environment

0

50

100

150

200

250

2010 2011 2012 2013 2014 2015 2016 2017 2018e

IgG

Ma

rke

t S

ize

in

to

ns

North America Europe RoW

14

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

IgG Market Size (Volume in tons)

• 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

Annual Growth –CAGR 2010 – 2018e

RoW 9%

Europe 8%

North America 8%

World 8%

Company Presentation Biotest AG

Global total IgG (i.v. and s.c.)

Geographical Volume Split – Development & Forecast

Biotest AG SB July 25, 201915

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

0

50

100

150

200

250

300

350

2010 2011 2012 2013 2014 2015 2016 2017 2018e2019e2020e2021e2022e2023e

IgG

Mar

ket

Size

in t

on

s

North America Europe RoW

• 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

Annual Growth –CAGR 2010 – 2018e

RoW 9%

Europe 8%

North America 8%

World 8%

Das ist der Biotest

interner Forecast

241 238

201

172

151 149 146

126110

102 99 97 9382

75

47

23 2013

6 3 10

50

100

150

200

250

300

kG Ig

G/m

illio

n p

op

ula

tio

n

IgG usage per capita 2017Consumption

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

• Increasing

consumption

worldwide

• Growing use in CIDP

in major markets

• Easier reimbursement

leads to market

growth

16Company Presentation Biotest AG

213*196*

91*

69*

99*

*IVIG usage per capita 2015

259 252

222

165

143 142 140129

119104 97

90

56

3426 22 20

12 10 8 4 1 1 00

50

100

150

200

250

300

USA

(e)

Au

stra

lia*

Can

ada*

(e)

Swit

zerl

and

(e)

Fran

ce

Au

stri

a

Ger

man

y

Irel

and

(e)

Netherlands…

Spai

n

UK

Ital

y

Turk

ey (

e)

Arg

enti

nia

(e)

Iran

(e)

Ch

ina

(e)

Hu

nga

ry

Bra

zil (

e)

Mex

ico

(e)

KSA

(e)

Ind

ia (

e)

Afr

ica*

(e)

Vie

tnam

(e)

Ro

man

ia (

e)

kg Ig

G/m

illio

n p

op

ula

tio

n

17

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

Comments• Increase of new PID

patients due to testing requirements in US: Continuous high demand

• Increased use of SCIG formulations

• Growing use in CIDP in major markets

• Increased need to treat SID due to more aggressive treatments

• Easier reimbursement leads to market growth

• Cost of treatment remains still a barrier to market expansion

• Claw back tax led to supply crisis in Romania

Ø per capita usage: 82 kgIgG/million population

Company Presentation Biotest AG

Immunoglobulines (IgG): Usage per capita in 2017

(kg per Mio. inhabitants; increase versus 2015 in %)

Biotest AG 18

• Rising global

consumption

• Significant growth

expected in the

Chinese market

• Consumption 2017:

20 kg/million

inhabitants

+13

%

+48

%

+39

%

+48

%

+21

%

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

Company Presentation

Australia ..Spain....Germany....France….USA

Immunoglobulines (IgGs): Further increase of global

market volume expected(Market volume in tons)

Biotest AG 19

47

107

172197

226

335

2000 … 2010 … 2016 2018 2020 … 2026

2010 vs. 2000

+60 tons

2018 vs. 2010

+90 tons

2026 vs. 2018

~ +140 tons

Source: Marketing Research Bureau (March 2019)

Company Presentation

Biotest core business overview

20

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

To treat disorders of

the immune systems

Passive immunity

against Hepatitis,

Cytomegaly,

Varicella etc.

To help body

control the blood

clotting

To treat low

blood volume in

critically ill

patients

Clotting FactorsHyper immuno-

globulins

Immuno-

globulinsAlbumin

Plasma Quarantine Fractionation Intermediates Purification Filling /

packaging

Finished

product

QC

Immunoglobulins

Hyper immunoglobulins

Clotting Factors

Albumin

Company Presentation Biotest AG

5 products out of 1 litre plasma

~ 12.5 t immunoglobulins

Inventment into BNL

Revenue /

litre plasma

Cost /

litre plasma

Gross profit:

€100 / l~€300 / l

~€200 / l

Revenue /

litre plasma

Cost /

litre plasma

~€550–€650 / l

~€240 / l

IgM &

Fibri-

nogen

Gross profit:

€310–€410 / l

Today (current factory) BNL ramped-up

3 products out of 1 litre plasma

Capacity expansion: ~ 6 t

21Biotest AGCompany Presentation

Product portfolio Biotest today / tomorrow

Today

Polyvalent IgGIntratect 5%

Intratect 10 %

Hyper – IgG/ Specialty productsHepatect (Hep B)

Zutectra (Hep B)

Fovepta (Hep B)

Cytotect (Cytomegalie)

Varitect (Varizella-Zoster)

Specialty productsPentaglobin (IgM enriched IgG)

Biseko

HaemophiliaHaemoctin (FVIII)

Haemonine (FIX)

Human AlbuminAlbiomin 5 %

Albiomin 20%

Tomorrow

Polyvalent IgG

IgG Next Gen

Specialty productsTrimodulin (IgM enriched IgG)

FibrinogenAcquired Fibrinogen def.

Congenital Fibrionogen def.

22

+

+

Biotest AGCompany Presentation

+

0

100

200

300

400

2016 2017 2018

StandardProducts

SpecialtyProducts

Biotest portfolio differentiation(€ million)

Company Presentation Biotest AG 23

Biotest has unique speciality

products in it´s portfolio:

- Cytotect

- Varitect

- Hepatect

- Zutectra

- Pentaglobin (IgM product)

- Biseko

- Speciality portfolio show

good growth rates

Therapy sales only

Expansion of plasma donation centres

Company Presentation Biotest AG 24

• Two new centres in Czech Republic

(Břeclav, Brno) in 2018

• One new centre in Germany (Hanover) and

one in Budapest (Hungary) in 2019

Europe: 21 centres

9

93

New plasma donation centre in Brno

Biotest plasma donation centres

Company Presentation Biotest AG 25

Research &

Development projects

Strategic pillars of BNL development program

27

F VIII Albumin Trimodulin FibrinogenIgG

F VIII Albumin IgGToday

BNL

• Globalization of products

• More products out of one litre plasma

• Specialty plasma products (high medical need)

Company Presentation Biotest AG

Everything Needs to Work Smoothly Together

24.06.2019 MAKING WAVES - Big Bang Meeting 28

BNL: Building and Equipment

Product Development

GxP Compliance

Research & development projects to market

• BNL product

development

• Life cycle

management

projects

2021

• IgG Next Generation

PID*

ITP**

• Albiomin

• Haemoctin

Today

29

>2021

• IgG Next Generation

Subcutaneous (SC)

Dermatology

• Trimodulin (IgM Con.)

• Fibrinogen

congenital

acquired

• Haemophilia A

Therapeutic

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

Biotest AGCompany Presentation 29

• New efficient production process with high IgG yield established

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

IgG Next Generation (IVIG)

Clinical development

• Phase III study in PID* (EU + US; study 991): enrollment completed,

treatment for children

ongoing

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

Company Presentation 30Biotest AG

*: 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

Company Presentation Biotest AG 31

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)

Company Presentation Biotest AG 32

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

Company Presentation Biotest AG 33

Fibrinogen

Company Presentation Biotest AG

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

34

Company Presentation

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

Biotest AG 35

• Neutralization of multiple pathogens

• Binding of toxins and inflammation

activators

• Reducing the secretion of immune

mediators

• Immune modulation

Trimodulin - IgM-enriched ImmunoglobulinBroad 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

Company Presentation 36Biotest AG

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 multi-

organ failure

Mortality

AntibioticsVentilation, hydration,

vasopressors,…

Causal

therapyTrimodulin

Supportive

therapy

Company Presentation Biotest AG 37

Competitor Mapping

24.06.2019 MAKING WAVES - Big Bang Meeting 38

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

home

hospital ICU

Broad spectrum monotherapy Broad spectrum

combination therapyAvycaz

Mono or combination antibiotics for intolerant patients

Xigris (withdrawn)Pentaglobin

Corticosteroids

Filters

low

pri

ce

hig

h p

rice

Trimodulin

Zerbaxa

Trimodulin – Upside Indications

24.06.2019 MAKING WAVES - Big Bang Meeting 39

Trimodulin

Peritonitis

MDR

NeonatalSepsis

Transplan-tation

Biotest Next Level: Progress in Dreieich

40

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

Company Presentation Biotest AG 41

Financial Calendar 2019/ 2020

Contact

Financial Calendar 2019

14 Nov 2019 Q1-Q3 Report 2019

30 Mar 2020 FY Report 2019

05 May 2020 Q1 Report 2020

Investor RelationsDr. Monika Buttkereit

Tel.: +49-6103-801-4406

investor_relations@biotest.de

Public RelationsDirk Neumüller

Tel.: +49-6103-801-269

pr@biotest.com