Biotest AGSilvio Audisio

Vice PresidentHead of East & South Europe

Bucharest, 15th January 2020

Agenda

Plasma & CollectionPlasma & Collection3

Specialist for LifeSpecialist for Life2

ProductionProduction4

Biotest GroupBiotest Group1

Global total IgG Development & ForecastGlobal total IgG Development & Forecast5

PPP ExamplePPP Example7

What Next Level?What Next Level?6

*as of 31. March 2018

Biotest Group

Headquarters in Dreieich

Subsidiaries in 10 countries

80 global distribution partners

Employees (FTE)*: 1,659

Founding of company 1946IPO 1987; SDAX 2007 (Preference Shares)

RevenuesFY 2018: € 400 millionQ1-3 2018: € 295 million

1

Biotest core business overview

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

To treat disorders of the immune systemsTo treat disorders of the immune systems

Passive immunity against Hepatitis, Cytomegaly,Varicella etc.

Passive immunity against Hepatitis, Cytomegaly,Varicella etc.

To help body control the blood clotting

To help body control the blood clotting

To treat low blood volume in critically ill patients

To treat low blood volume in critically ill patients

Clotting FactorsClotting FactorsHyper immuno-globulinsHyper immuno-globulins

Immuno-globulinsImmuno-globulins AlbuminAlbumin

Plasma Quarantine Fractionation Intermediates Purification Filling / packaging

Finished product

QC

Immunoglobulins

Hyper immunoglobulins

Clotting Factors

Albumin

Biotest – Specialist for Life

Three Therapeutic Areas

Haematology

Diseases of the bloodand blood-forming

system

Clinical Immunology

Disorders of theimmune system

Intensive Care Medicine

Acute, mostly lifethreatening diseases

Haemoctin®, Haemonine®

Vihuma ®

Intratect® ,Hepatect®Zutectra®, Fovepta®

Cytotect® ,Varitect®

Pentaglobin®,Human Albumin

Biseko® ,Cofact®

Basis for all our Products: Human Blood Plasma

2

Biotest's Resource: Plasma & Collection

55%

45%

Blood-Plasma

Blood-cells

8%2%

90%

Blood Plasma

Water

ProteinsSalts a.o.

60%

4%

Clotting Factors

30%

Immunoglobulins

Albumin

16%

Transport- a.Lipoproteins

Proteine

3

Plasma donations as source for patients

Ca. 1.200 Plasma donations

Donations required forone patient per year

Primary ImmundeficencyHaemophilia A

Ca. 120 Plasma donations

Haematology Clinical Immunology

Expansion of plasma donation centres

• Two new centres in Czech Republic(Brno, Jihlava) in 2019

• One new centre in Germany (Hanover) andone in Budapest (Hungary) in 2019

Europe: 25 centres

12

94

New plasma donation centre in Brno

Plasma Collection

Multiple country specific restrictionsExample: Albumin for China may only be produced from US-plasma

Products for the US market have to be produced from US-plasma

Whole Blood Donation250ml per donor, 4 x per year

Apheresis‐Plasma800 ml per donor, several times a week

"Recovered Plasma" "Source Plasma"

Biotest plasma donation centres

Europe: huge differences and rules amongs member state

Europe: difficult to achieve “self-sufficiency”

Europe: significant differences on plasma donation infrastructure

Production: 9 months from collection to product

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Product

60 days

Plasma donation

4

9 months from collection to product

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Plasma donation Product

60 days

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

1. Inventory Hold 5. Filling and Packaging

4. Nanofiltration (20nm)

2. Fractionation

of plasma

3. Chemical treatments

Purification

Plasma donation Product

60 days

HBV HCVHAV HIVPB19

PCR

Inventory Hold and PCR testing

9 months from collection to product

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

60 days Purification

1. Inventory Hold

Product

Fractionation of plasma Virus elimination

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

60 days

Paste IIContainsImmunoglobulins

„Waste“ Source for Albumin

HBV HCVHAV HIVPB19

Thawed plasma

+ Ethanol

9 months from collection to product

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Product

60 days

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

Chemical treatments Virus inactivation

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Product

60 days

HBV HCVHAV HIVPB19

TNBP

Caprylic Acid

Tween-80

9 months from collection to product

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Product

60 days

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

Nanofiltration (20nm) Virus elimination

ProductPlasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

3. Chemical treatments

Purification

1. Inventory Hold

60 daysvoid

capillary

HBV HCVHAV HIVPB19

9 months from collection to product

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Product

60 days

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

Filling & Packaging

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

60 days

9 months from collection to product

Plasma donation

5. Filling and Packaging

4. Nanofiltration (20nm)

• Quarantine at -35°C• Viral PCR testing

(HIV, HAV, HBV, HCV, B19V)

2. Fractionation

of plasma

3. Chemical treatments

Purification

1. Inventory Hold

Product

60 days

Global total IgG Geographical Volume Split – Development & Forecast

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 M

arket S

ize in to

ns

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%

5

259 252

222

165143 142 140

129119

104 97 90

5634 26 22 20 12 10 8 4 1 1 0

0

50

100

150

200

250

300

USA

 (e)

Australia*

Canada* (e)

Switzerlan…

France

Austria

Germany

Ireland

 (e)

Nethe

rlan…

Spain

UK

Italy

Turkey (e

)

Argentinia…

Iran (e)

China (e)

Hungary

Brazil (e)

Mexico (e)

KSA (e)

India (e)

Africa* (e

)

Vietnam (e

)

Romania (e

)

kg IgG/m

illion po

pulatio

nGlobal 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

213*196*

91*

69*

99*

*IVIG usage per capita 2015

Rom

ania

(e)

FVIII Albumin IgM FibrinogenIgG

FVIII Albumin IgG

FVIII Albumin IgM FibrinogenIgG

Further Possibilities• Fibrinogen (high yield process)• C-1 Esterase INH

Further Possibilities• Fibrinogen (high yield process)• C-1 Esterase INH

Today

BNL

Longer-term

Alpha-1 Antitrypsin

• PPSB• RSV and other Hyperimmunoglobulins

Strategy: More Products out of one Liter Plasma6

Example of PPP

Involved Parties: Biotest, Maxicells, Glatt, SGK (Turkish Public Health Insurance)

Product Scope: Albumin, Intratect, Haemoctin, Haemonine

Project Timeframe: 6 years until start of local fractionation plant

• Supply of agreed upon quantities at fixed commercial terms

Finished Goods

• Supply of Turkish plasma for 

fractionation at Biotest plant

Toll Manufacturing  • Local Plasma 

Fractionation in Turkey

LocalFractionation

Y 1‐2 Y 2‐6 from Y 6

7