innovation quality...

InnovationQualityQuality

Responsibility

Annual Shareholders’ Meeting of Biotest AG7 May 2014

2014 Annual Shareholders’ Meeting 0Biotest AG

Biotest – Our mission

• New drugs, new indications Innovation• Further development of authorised drugs

Quality • Safety

• Tolerability

• User friendliness

• Patient benefit

ResponsibilityPatient benefit

• Due diligence

L t i

2014 Annual Shareholders’ Meeting Biotest AG 1

• Long-term view

InnovationInnovationQuality

Responsibility

Biotest in

Responsibility

2013


2013 – one of the best years in Biotest’s history

• Record sales, € 500 million threshold exceeded for the first time

• Strong earnings growth

• Position in the US market strenghthened, internationalisation driven forwarddriven forward

• Capacity expansion project begun

• Successful on the capital markets

3Biotest AG2014 Annual Shareholders’ Meeting

Biotest headquarters in Dreieich

Strong growth in sales

Sales (€ million)

+13 8%

400

500+13.8%

• Growth in all distribution regions

• Particularly sharp increase in

500 8300

400 Particularly sharp increase in sales in the US and Asia

• Percentage of international 440.0

500.8200

gbusiness is continuing to increase

0

100

4

2012 2013

2014 Annual Shareholders’ Meeting Biotest AG

Above-average increase in EBIT and EAT

EBIT (€ million)

+20.4%

Earnings after taxes (EAT) (€ million)

40

50

40

50

30

40

53.830

0

+38.5%

23 132.0

2044.7

20

23.1

0

10

0

10

2012 2013

5

2012 2013* * Continuing Operations


*

Financial position shaped by financing measures

1000

Financial position of the Biotest Group (€ million)

Assets Liabilities

800

900 886.5 886.5

324.0

314 9

460.7600

700 Shareholders' equity

Non-current liabilities

682.3 682.3

562 5

314.9

301 5

369.4

300

400

500Current liabilities

Non-current assets562.5

367.4

124 3164.9

301.5148.0

100

200

300

Current assets

124.30

6

31.12.201331.12.2012 31.12.201331.12.2012


Sales and earnings in the first quarter

Sales (€ million) EBIT (€ million)

125 118.7 122.2

10

12 11.810.7

75

100

6

8

10

25

504

6

0

25

Q1 2013 Q1 20140

2

Q1 2013 Q1 2014

72014 Annual Shareholders‘ Meeting Biotest AG

Continue and accelerate growth

Biotest Group: sales 2004–2013 (€ million)*

600

Sales target for 2020:

~ € 1 billion

500

600

500.8

300

400

200141.9

20132004 2005 2006 2007 2008 2009 2010 2011 2012

0

100

8

2013

* On a comparable basis, only pharmaceutical activities


2004 2005 2006 2007 2008 2009 2010 2011 2012

Biotest stock greatly outperforms the benchmark

Biotest share price performance (closing price 8 May 2013 = 100)

170

180

150

160

170

SDAX BIO3 BIOSt.Vz.

120

130

140

100

110

120

May 2013 May 201480

90

9Biotest AG2014 Annual Shareholders’ Meeting

Higher liquidity increases the stock’s attractiveness

Monthly turnover of the Biotest preference share [Xetra in € million]Monthly turnover of the Biotest preference share [Xetra in € million] € million

45

50

2012 2013 2014

30

35

40

45

15

20

25

30

5

10

15

0Jan 12

Feb 12

Mrz 12

Apr 12

Mai 12

Jun 12

Jul 12

Aug 12

Sep 12

Okt 12

Nov 12

Dez 12

Jan 13

Feb 13

Mrz 13

Apr 13

Mai 13

Jun 13

Jul 13

Aug 13

Sep 13

Okt 13

Nov 13

Dez 13

Jan 14

Feb 14

Mrz 14

Apr 14

• Capital increase ensures greater tradability

• Biotest share becomes attractive for international investors


• Biotest share becomes attractive for international investors


Responsibility

Strategy

Responsibility

gy


Position strengthened in the attractive US market

• Successful start to the marketing of Bivigam® in 2013

• Sales forecasts for Bivigam ®

− about US$ 60 million for 2014 b t US$ 100 illi f− about US$ 100 million p.a. from

2015 onwards

• Number of plasma collection centres in the US will increase to 18 by the

d f 2014

BPC headquarters in Boca Raton, Florida

end of 2014

• Promising development projects


Production network offers great advantages

1

1 23

33

3

Global marketing, Plasma collection Processing into 31 2 gincluding in the EU, China or South America

in US collection centres, initial processing in

gfinished products, filling/packaging

31 2

2014 Annual Shareholders’ Meeting Biotest AG 13

Boca Raton at Dreieich

Entering additional growth markets

• China: third largest pharmaceutical market in the world, two-digit growth rates

• Marketing authorisation for Albiomin® 20% expected by Biotest for the fourth quarter 2014

B il fifth l t t (b l ti ) i• Brazil: fifth largest country (by population) in the world

• Rapidly growing market for plasma proteins• Marketing authorisation for Albiomin® 20%

received in November 2013, further plasma proteins in the marketing authorisation


procedure

Global market for immunoglobulins continues to grow

Global market volume for IVIG (tonnes)

200

Further additional demand up to 2020: 75 tonnes75 tonnes

Capacity increase at Biotest up to 2018: 7.5 tonnes

125


Biotest Next Level: Investments in growth

• Programme for increasing capacity at Plasma fractionation:

Increase in global capacity to:

Dreieich

• Construction of new production f

3.1 million litres per year current: 1.5 million litres per year

facilities at the Dreieich location

• Period: 2013 to 2018Immunoglobulins:

13 tonnes per year• Investment amount: > € 200 million

• More than 300 additional jobs

13 tonnes per yearcurrent: 5.5 tonnes per year

Alb i • More than 300 additional jobs Albumin:

72 tonnes per yearcurrent: 42 tonnes per year

16

current: 42 tonnes per year


First projects initiated or already completed

Already completed:• Expansion of filling and packaging

facilities• First expansion of albumin production• New multi-storey car park e u t sto ey ca pa

Construction started:• Plasma goods receipt areag p• Virological test laboratory

Next steps:Completed multi-storey car park

• Basic engineering completed in Summer 2014

• Ground broken for new production


Ground broken for new production building by the end of 2014


Responsibility

Research &

Responsibility

development


Clinical Immunology: Civacir®

• Hepatitis C immunoglobulin for reinfection prophylaxis after liver transplantation

• Very high demand:− Currently no reliable prophylaxis for the

critical period immediately after transplantation

− New virostatic drugs are not an optiong p− In the EU and USA alone, more than

5,000 liver tranplants due to hepatitis C each yeareac yea

− Phase III study is underway; treatment of the first patients has already been completed

Model of hepatitis C virus

19

completed


Intensive Care Medicine: IgM concentrate and fibrinogen

• IgM concentrate for the treatment of sepsisIgM concentrate for the treatment of sepsis• Unique mechanism of action• Over 100 patients treated to date in

h II t dphase II study

• Fibrinogen for the treatment of severe acute bleeding due to fibrinogen deficiency

• Ready to use product is in development• Ready-to-use product is in development• First patients treated in phase I/II study


Biotest products and pipeline

Cli i lHaematology Clinical Immunology

Intensive Care

Medicine

Haemoctin® Intratect® Pentaglobin®

Haemonine® Hepatect®, Nabi-HB®

Zutectra®

Cytotect®

HumanalbuminBiseko®

Cofact®Varitect®Bivigam®

F t ®Indatuximab Ravtansine (BT-062)

Fovepta®

Civacir®

Cytotect 70 (BT-094)Tregalizumab (BT 061)

IgM concentrateFibrinogen

21

Tregalizumab (BT-061)


Monoclonal antibodies extend the range of products in the Clinical Immunology and Haematology areas


Haematology: Indatuximab Ravtansine (BT-062)

• Clinical development in the lead indication multiple myeloma is continuing

• Very convincing data from current phase II study

• Partial to complete remission of the disease in about 75% of treated patients

• Presentation of the data at the prestigious ASH conference encountered a great response

Targeted mechanism of action:

• Antibody docks on cancer cell and toxin is then released:

• Targets cancer cells while healthy cells are very largely spared


High efficacy in tumour treatment

• Very high efficacy with a tolerable dosage in the treatment of solid

Treatment of human breast cancer implanted in mice

tumours that do not respond to standard therapy

T l d l t l100

1000

an)

[%] Taxol

dian

) [%

]

• Tumours resolved completely within 14 days

• No recurrence (renewed growth)

10

100

org

röß

e(M

ed

iou

r siz

e (m

ed

• No recurrence (renewed growth) after the end of the treatment, no metastases

0

1

Re

lative T

um

o

0.1Indatuximab Ravtansine

Rel

ativ

e tu

mo

• Start of clinical development in breast and bladder cancer

00 7 14 21 28 35 42 49 56 63 70

R

0.01

Treatment and observation duration in days

R


High need and large sales potential

Patients* Sales potential

Indication focus of Indatuximab Ravtansine (BT-062)

Patients Sales potential(peak net sales per year)

~ 80,000 ~ € 950 million

Multiple myeloma (recurrent and treatment-resistant)

Triple-negative metastatic breast cancer

~ 50 000 ~ € 300 million

Metastatic bladder cancer

50,000 € 300 million

90 000 € 750 illi~ 90,000 ~ € 750 million

25

* Anticipated potential patients / Source: Decision Resources 2013 for seven important markets, Biotest estimates


Clinical Immunology: Tregalizumab (BT-061)

• Developed in the lead indications of rheumatoid arthritis (RA) and psoriasisarthritis (RA) and psoriasis

• Treat 2b: phase IIb trial in RA started in autumn 2013T cell REgulating Arthritis Trial 2b

• Largest clinical trial in Biotest history:− Over 300 patients

T cell REgulating Arthritis Trial 2b(TREAT 2b)

− Over 70 trial sites in 14 countries− Final results in the first six months of 2015

O h lf f h l d i h l d• Over half of the planned patients have already been entered in the trial


InnovationQ litQuality

ResponsibilityAnnual Shareholders’ Meeting of Biotest AG

7 May 2014


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