Biotest AG — Investor Presentation 2010

Apr 23, 2010

Biotest Group: Creating Value. Living Values

Financial Year 2009Management Presentation

Disclaimer

This document contains forward forward-looking statements on overall economic looking overall 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 update forward-looking statements and assumes no looking obligation to do so.

All figures reported relate to the Continuing Operations of the Biotest Group after relate Biotest the disposal of the transfusion and transplantation diagnostic activities to Bio-Rad Laboratories Inc. These activities are being reported as Discontinued Operations. With the exception of the statement of financial position, the previous year´s figures have been adjusted accordingly.

All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest at a glance

K F i F Y 2 0 0 9 e y g u r e s	:
S l a e s T h f P l P t i e r e o a s m a r o e n s E B I T	€ 4 4 0 2 m € 3 9 0. 1 m € 6 1 5 m	( 1 4. 1 % ) + ( 1 4. 9 % ) + ( 4. 2 % ) +

Business sectorsPharmaceuticals Diagnostics Divisions• Immunoglobulins Plasma Proteins• Monoclonal Biotherapeutics • Hygiene Microbiological Monitoring • Hyper-immunoglobulins • Clotting factors • Albuminantibodies monitoring

Biotest Group

• • Headquarters in Dreieich/Germany (Frankfurt area)
• •Subsidiaries in 11 countries worldwide
• • E l (FTE)* 1 850** Employees (FTE)*: 1,850** Thereof 41% located outside Germany
• • Founded in 1946, , IPO in 1987, SDAX in 2007 (preference shares)
• • Biotest shares:
• •6,595,242 ordinary shares
• •5,133,333 preference shares

*: as of 31 Jan. 2010 **: Continued Operations Headquarter, Dreieich

Biotest Group overview

European production and distribution sites

Additional sites overseas:

• •USA: Florida ( ), Rockaway ( )
• •Japan: Tokyo ( )
• • Distribution also via 138 distributors in76 countries

Sales by region (2009):

About Biotest – strong track record

• • Strong revenue growth, particularly in Plasma Proteins business
• • Plasma Proteins account for 81% of Group's sales in 2009
• • EBIT increase by 131% from 2005 to 2009

Shareholder structure

G B i t t A o e s
O d i h r n a r s a r e s y i t h t i i o n g r g w v	6 6 i m o : h t s	P f h 1 i 5 r e e r e n c e s a r e s : m o i i h b h i h d i i d d t t t n o v o n g r g s, u g e r v e n
O G G : E L b H m S : K K B i b h e r a c	% 5 0 0 3 % 2 4 ~	% F F l t 1 0 0 r e e o a :
F F l t r e e o a :	2 6 % ~

56.4% of total capital, and 100% of voting rights 0% o

43.6% of total capital, 0% f i i hf voting rig hts

* as of March 2010

Biotest: History and milestones achived

1 9 4 6 B i t t : o e s S I i t t t e r u m n s u G b b H H m	1 9 6 1 N : e w d i t p r o u c o n f i l i t t a c y a D i i h r e e c	1 9 8 7 I P O : 1 9 9 1 S f t t : a r o	2 0 0 7 : C l i i l i t t n c a e s n g - f l l o m o n o c o n a i b d i t a n o e s
1 9 4 8 T t : e s S A i- D t e r u m n	1 9 6 8 F i t : r s b i d i s s a r u y G t i d o s e e r m a n u y ( I l ) t a y 1 9 7 1 M k t h ® l a r e a n c : u f I t l b i o n r a g o n ( l i f i p o y s p e c c i l b l i ) m m u n o g o u n	M i b i l i l c r o o o g c a M i t i o n o r n g 2 0 0 4 S f t t : a r o d i d m o e r n z e P l P i t a s m a r o e n s d t i p r o u c o n	A i i t i f c q s o n o u - N b i a P f r e e r e n c e - h i S D A X s a r e n 2 0 1 0 D i f t t : v e s m e n o M d i l D i i t e c a a g n o s c s
1 9 6 4			2 0 1 0

Biotest Group: Highlights 2009 and Q1 2010

• • Biotest FY 2009 Group Sales up by 14.1% and EBIT increased by 4.2%
• • Sales and EBIT above 2009 Guidance of: Sales +10% and EBIT at € 55 million
• • Medical Diagnostics: Closing of purchase agreement with Bio-Rad Laboratories, Inc. on Jan. 6, 2010
• • Zutectra® : launch started on Feb. 15, 2010 in Germany
• • Major milestones achieved in Plasma Proteins and Biotherapeutics
• • Compp y letion of first production facilit y in Boca Raton

Biotest Group: Creating Value. Living Values.

Financials

Biotest to sell Medical Diagnostics business to Bio-Rad

• • Contract signed to sell a major part of the Medical Diagnostics segment to Bio-Rad Laboratories Inc (Hercules CA/ US) Rad Inc. (Hercules,
• •Transaction successfully closed on Jan 6, 2010
• • Bio-Rad acquired all shares of Biotest Medical Diagnostics GmbH (Dreieich) and Biotest Diagnostics Corporation (Rockaway/ US), as well as the transfusion and transpg p lantation dia gnostics business in Biotest Grou p´s international subsidiaries under an asset deal; revenues of activities sold in 2009 : € 40.8 million
• • Purchase price of € 45 million bein g y paid b y Bio-Rad on Jan 6, 2010

million €

Gain of transaction Medical Diagnostic Business

S l l i P i e n g r c e	4 5 0 ,
f ( ) N t l t h l d b i d i i h d l e v a u e o e s o s u s a r e s s a r e e a	8 9 - ,
f ( ) N t l t h l d t t d l e a e o e s o a s s e s a s s e e a v u	3 2 - ,
T f f h h l d 's l r a n s e r o s a r e o e r o a n s	1 3 3 - ,
R i ( i ) t t t t t e s r c r n g c o s s e s m a e u u	4 0 - ,
A d d i i l f h i t t t t t o n a c o s s o e r a n s a c o n	2 2 - ,
G i f h i / d i i t t t t a n o e r a n s a c o n e x r a o r n a r y n c o m e	1 3 4 ,

•Purchase price of € 45 million was received on Jan. 6th 2010

Strong sales growth

Sales of Plasma Proteins & Microbiological Monitoring (€ m)

• • Strong sales growth in 2009 in in Plasma Proteins and Microbiological Monitoring
• Growth across all Plasma Protein product groups
• • Growth of Immunoglobulins due to i di ti hi h d imore indications, higher dosing per patient
• •Leading position of Biotest products 46.4

Microbiol. Monitoring Plasma Proteins

R&D Expenses: Continuous increase

R&D ( € ) •R&D expenses (€ m)

R&D expenses 2009 stable at 11% of Group sales (2008: 11%)

Plasma Proteins:

• • European approval of Zutectra ®
• •Additional European approvals for Intratect, Hepatect and Albiomin
• • Completion of Phase III of IVIG in the US

Biotherapeutics:

• • Progress of clinical and preclinical preclinicalstudies
• • Establishment of mAb production f ilit i B R t facility in Boca aton

Strong EBIT growth in Plasma Proteins

80100 +11% 80 7 89.2 6080.720405.6 4.402008 2009-21 %

•

EBIT Plasma Proteins and Microbiological Monitoring (€ million)

• Increase in EBIT by 4.2% vs. 2008
• • Main reasons for lower EBIT margin:
• C t i ti ithCosts in connection withreconstruction of BPC manufacturing plant
• Higher raw material costs
• Depreciation of inventories due to decreasing market prices in

Plasma Proteins business drives EBIT

EBIT by segments (in € million)

	2 0 0 9	2 0 0 8
P l P i t a s m a r o e n s	8 9 2	8 0 7
B i t h t i o e r a p e c s u	2 1 1 -	1 6 8 -
M i b i l i l c r o o o g c a M i t i o n o r n g	4 4	5 6
C / R i l i i t t o r p o r a e e c o n c a o n	1 1 0 -	1 0 5 -
T l C i i t t o a o n n u n g O i t p e r a o n s	6 1 5	9 0 5

• • EBIT of Plasma Proteins segment increased by 10.5 %
• • Biotherapeutics EBIT influenced by level of maturity of clinical studies
• • EBIT of Microbiological Monitoring planned lower as 2008 due to higher marketing and R&D costs

Decrease in profit in 2009

EBT and EAT (in € million)

• • Rise in earnings before tax ( ), EBT due to more favourable financial result as a result of lower interest expenses
• • Financial result: € -12 8 million 12.8(2008: € -13.5 million)
• •Earnings after tax (EAT) at € 32.7
• • Tax impact 2009: € -17.1 m (2008: € -12.8 m) due to higher t d d t blnon tax eductable expenses
• •Tax ratio: 34.9% (2008 : 28.1%)

Key Financial Figures

	2 0 0 9	2 0 0 8	•
* E A T f f b b i i e o r e m n	3 1 9	3 2 7
E P S * ( d i h ) p e r o r n a r y s a r e	2 4 9	2 5 6	•
E P S * ( f h ) p e r p r e e r e n c e s a r e	2 5 5	2 6 2	,
R O C E ( % )	1 1 1	1 1 7
D i i d d ** v e n ( d i h ) p e r o r n a r y s a r e s	0 3 4	0 3 0
D i i d d ** v e n ( ( f f h h ) ) p e r p r e e r e n c e s a r e	0 4 0	0 3 6
Ma h 2 0 1 0 rc		B io tes t A	G

• • The ROCE was influenced by increase in current assets (working capital)
• • Higher dividend to be proposed at the Shareholders' meeting on May 6th 2010

^* Continuing Operations; **The dividend 2009 to be proposed at the Shareholders' meeting on May, 6th, 2010

Strong balance sheet

Balance sheet of the Biotest Group

(in € million)

A tAsses

• • Higher inventories driven by expected growth in 2010
• • Higher Trade receivables due to higher sales volumes mainly in the plasma proteins segment

Liabilities

• • Increase in current financial current liabilities, primarily corresponding to working capital development p
• •Equity ratio as of 31 Dec. 2009:

Cash Flow from Operating Activities in € million 2009

Long term secure debt financing

Biotest Group: Maturity of financial liabilities (€ million)

• • Total financial liabilities as of 31 December 2009: € 204.5 million (2008: € 194.8 million)
• • Successful renewal of working capital facility of € 40 million and new working capital line of € 10 million
• • Further financing available – but at g higher interest rates
• • Purchase price of € 45 million was received on Jan 6th on Jan.

Global Economic Crisis: Higher vigilance necessary

• •Most products of the Plasma Proteins segment are life saving in nature
• • Plasma Proteins segment with opportunities in both developed and emerging markets
• • G hi eographi c di it vers y due to i t ti l internationalb i us ness (E t as ern Europe, A i ^s a, US)

But:

• •Potential challenges in public health care policies and reforms
• •Pressure to re duce h lth ea care spending mi ht g (o rwill) arise
• •Increased risk of loss of receivables (PIGS)

Outlook 2010

Start in financial year 2010:

• W k t t d t hi h l d f 2009Weak start due to high sales end of

Our goals for the year 2010:

• • Increase in ^a low single digit range - provided tender business on previous year level
• • EBIT 2010 l l f 2009 id d th t th ill b f th i 2010 on level of 2009, provided that there will be no further price reductions and stable conditions of health care systems

Biotest Group: Creating Value. Living Values.

Plasma Proteins

Plasma Proteins business at a glance

Biotest Plasma Protein products

• •Global market share: 3%
• • Market share in relevant markets (GER AUT CH GRE UK) 14% (GER, AUT, CH, GRE, UK):
• • Intratect ® market share in GER, AUT, CH: > 13%, in UK: > 10%
• • World market leader with Cytotect ®and Varitect®
• • Leading position with Hepatect ® in Europe and Nabi HBTM in USA
• • Zutectra® launch in Feb. 2010 in
• • Biotest covers full value creation chain: plasma sourcing, production, distribution ti l i t ti l d tvertical integration lea ds to rationalisation and higher productivity

Plasma Proteins: Production process

Plasma Proteins production – capacity doubled

Biotest production network* p

Fractionation:

• •Plant in Dreieich: 700,000 litres p.a.
• C t t ith C A F D C F (B l i ) • Contract with C.A.F-D.C.F (Belgium): up to 300,000 litres p.a.
• ¾Facility included in regulatory files
• ¾10 year contract
• • Boca Raton: 400,000 litres p.a. (from Q3/ 2011)

Immunoglobulins:

• • Capacity in Dreieich doubled
• • Capacity expansion in Boca Raton (1 5 tonnes p ^a from Q3/2011) (1.5 p.a.

^* In the final construction stages (2010/11)

Plasma Proteins: further growth in sales, but at a slower rate

Plasma Proteins: sales volume (in € million)

• • In FY 2009 Plasma Protein sales increased by 14.9% to € 390 1 million 390.1
• • Sales in Plasma Proteins jumped by 37% in 2008 (incl. BPC for the +14.9%

IVIG Market Development

• For the next 5 years, a stable increase of ~5 % p.a. is expected, with the growth rate in the emerging countries exceeding the one in the developed countries

Source: MRB, APFA, Biotest Market Research

Development of IVIG Pricing in the US and the WW Market Growth, 2005-2009

• • The IVIG pricing in the US market has increased within the last 5 years, regardless of changes in the worldwide market growth rate and overall supply situation
• ¾ US as a highly attractive market even if growth rates decline
• ¾ Bi t t' IVIG ill t th US k t i 2011 otest's IVIG will enter the US marein 2011

Source: MRB, APFA, CMS

US source plasma collection forecast, 1996 -2013

Source: MRB "The Plasma Fractions market in the United States", 2007; PPTA; own estimates

Enlargement of Production Facility in Boca Raton is of high strategic importance

Status Projekt IVIG and Boca Raton (USA)

•IVIG clinical Phase III

• Clinical phase III study completed
• Draft of clinical study report in Dec 2009 Dec.

•Enlargement of production facility

• Comp p y (p ) letion of production facilit (part 1) in Q4 2009
• Final completion of utility systems and warehouse (part 2) in Q2 2010
• Final capacity: 400.000 l fractionation 1.5 t immunoglobulin purification
• Re-Start of Nabi-HB production
• First IVIG conformance charges produced Dec. 2009

•Registration of IVIG

• Submission of BLA to FDA in Q3 2010
• Expected approval in Q3 2011

Further growth of immunglobulin market expected

Demand growth driven by ¹⁵⁰

• •Favorable demographics: age, weight
• • Improved diagnosis, higher dosing level and longer time on therapy [mg] per capita
• • Continued clinical evidence supporting established and new indications
• •Geographical expansion

Biotest well positioned by diversified portfolio

• • Intratect ® – a premium product concerning tolerability *
• •IVIG available in US 2011
• • Speciality Hyperimmunoglobulines: Hepatect ®, Zutectra®, Varitect ®, Cytotect ®
• • sc application: Zutectra ®
• • Biotest is world market leader in hepatitis B Hyperimmunoglobulin

Source: Global Insight, MRB, PPTA, APFA

*: Poster: "A European, multicentre, open and prospective study on clinical efficacy, safety, and pharmacological properties of Intratect® (human normal immunoglobulin for iv administration) in patients with primary immunodeficiency (PID)"; E. Bernatowska et al., 2006

Hepatect ® CP and Zutectra®:

The perfect product portfolio for Hepatitis B reinfection prophylaxis after liver transplantation

	i h 6 F t t r s m o n s		l f i F o r e
D i r n g u t l t t i r a n s p a n a o n	W k 1 t e e p o s t l t t i r a n s p a n a o n	F k 2 r o m e e w d o n a r s, w f d j t t a u s m e n o i i H B t t t c o n s s e n a n s i 1 0 0 I U / L t t > r e s	M i h t t a n e n a n c e e r a p y, i H B i 1 0 0 I U / L t t t > a n s r e
1 0, 0 0 0 I U / 2 0 0 l m	D i l 2 0 0 0 I U / 4 0 l a y m ,		/ 5 0 0 I U k ~ e e w

Hepatect ® CP and Zutectra ® :

The perfect product portfolio for Hepatitis B reinfection prophylaxis after liver transplantation

• proven efficacy

• weekly ^{s c} injections Hepatect CP is worldwide the best documented Hepatitis B Immunglobulin for this indication

• i.v. application for high dosage therapy fast, pain free s.c. application for i ^t th ^t ti ^{d i} application high during and after transplantation maintenance therapy at any time during the day; well tolerated

• consistent antibody levels achieved by s.c.
• self treatment means less visits to physicians and more individual flexibility

Biotest received positive opinion for Zutectra ®

H H t i t i B m a n e p p a s u	T h e r a
i l b l i ( H B I G ) m m u n o g o u n	•
f d f l f t m a n u a c u r e r o m p a s m a o
d i h h i h i- H B t t o n o r s w g a n s
t i b d t i t a n o r e s y y

First subcutaneous injectable HBIG f lf d i i t ti bfor self-aministration by the patient

peutic indication:

• Prophylaxis of HBV re-infection after liver transplantation

Properties:

• • Subcutaneous injectable HBIG in a pre-filled syringe = ready-for-use
• • Hi gh s pecific activit y of 500 IU/ml gp ^y

Clinical Results:

• Effective anti-HBs-serum levels achieved in all i i h i i i l i h klpatients in t he registration trial with weekly Zutectra®application, no infection

Timelines:

• •Positive CHMP* opinion, Sept. 2009
• • EU Commission approval scheduled for December 2009
• • Launch in major EU countries in 2010 *Committe for Medicinal Products for Human Use

Biotest is a mayor player in Hepatitis B Immunoglobulin (HBIG) market

(Marketing Research Bureau, Inc.)

• • Use of HBIG after transplantation is mandatory
• • Biotest is world wide market leader with Hepatect ® in Europe and Nabi HBTM in USA
• • Zutectra® enhances Biotest competence and engagement in the HBIG market
• Zt t® ill t th d d f d t• Zutectrawill strengthen an efend currentstrong market position by preventing possible switch to i.m. and future i.v. drugs
• F th L h f Z t t® d N bi Tl ^{i 12} • Further Launches for utectraanabiHBTM already scheduled in attractive world wide markets

Opportunities in Haemophilia market

Increasing global standards of care

• •Improving access to care
• I i l b l t ti f• Increasing glo al penetration o hemophilia therapy
• • Optimization of compliance, dosing and prophylaxis treatment

Biotest Products

• • Haemonine® (Factor IX) introduced in 2008
• • Haemoctin® (Factor VIII) contains high level of von Willebrand factor
• • Haemoctin® is stable at RT for 2 years without artificial stabilisers, sugar free

• • Haemoctin® has shown to be efficacious in FVIII inhibitor therapy

• • R&D expenses in 2009 in the Plasma Protein segment: € 25 7 m.

• • Continous high investments in R&D in Plasma Proteins will guarantee future growth of the Plasma Proteins business
• • Goal:
• ¾ international regulatory registration and approval for all major Biotest products and intermediates

Cytotect

Lead indication:

Prevention of congenital CMV infection in newborns of CMV seroconverted women during pregnancy

Phase III Trial

• • More than 4.000 p g re gnant women have been screened until end of 2009
• •Study centers in Germany, Belgium, Hungary, Austria
• •Interim Analysis available end of 2010

IgM Concentrate

IgM Concentrate is successor product of Pentaglobin, containing approx. 2x amount of IgM; optimal functional properties to neutralise endotoxins and to optimal neutralise and inactivate bacteria

Lead d cat o indication: Se ^{e e} ec ^{o s} (e g se ^{e e} p eu ^o a) ^v re Infectins (e.g. vrneumonia)

Phase I trial:Status completed (last patient last visit: Dec 30th, 2009)

• • No major safety issues, no occurrence of serious adverse events in both single and repeated dosage
• •Pharmacokinetic data confirm expected dose for Phase II

Ph II t i l Phase rial:

• •Protocol in development
• •Study sites for core-indication are identified
• •Further indication is currently evaluated

Hep g atitis B immuno globulin in neonates

Phase III trial

• •Status: Recruitment ongoing (5 sites have recruited 30 patients)
• • E d f St d l d f Q3 2010 nd o udy planne for
• • Marketing Approval: aiming for marketing approval in Germany first, international marketing authorisations to follow

Summary Plasma Proteins: Biotest made significant progress in implementation of its corporate strategy

• •Biotest will grow the Plasma Proteins segment
• •Presence in the U.S. market extended
• • Reg y pp p ulator y approval for IVIG ex pected Q3 2011 Market potential for this product in USA estimated to be > \$ 100 m
• • Strong R&D pi li N d t d li i l i di ti ipeline: New pro ducts and new clinicalindications

Biotest: Creating Value. Living Values.

Biotherapeutics

Biotherapeutics: investment in projects with potential

Common features of Biotest's monoclonal antibodies

• •High medical need
• •Rapidly growing markets
• •Blockbuster potential

Lead indications

	R h t i d A t h i t i e u m a o r r s, P i i s o r a s s
0 6 2 B T-	M l t i l M l u p e y e o m a
B T- 0 6 3	S t i L s e m c p s y u u E t h t d r e m a o s s a n y u h i t t o e r a u o m m u n e d i s e a s e s

Rheumatoid Arthritis and Psoriasis –a huge and growing market

Market volume (in US\$ million)

BT-061 − Specific mode of action addressing key regulatory function of the human immune system

Clinical development BT-061

Overview

S t d u y n o	I d i t i n c a o n	D i e s g n	S b j t / e c s u P t i t a e n s P l d a n n e	S t t a s u
9 6 1	H l h l t t e a o n e e r s y v u	i l d s n g e o s e i d 1 8 0 t a n s c p o m g v ; u	5 7	S t d u y l t d c o m p e e
9 6 7	/ P h I I I P i i a s e a : s o r a s s	i l d s n g e o s e, l b t l l d i d p a c e o c o n r o e a n s c v	5 5	S t d u y l t d c o m p e e
9 7 3	P h I I P i i a s e : s o r a s s	l i l d t m p e o s e, u l b t l l d p a c e o c o n r o e	4 8	R i t t e c r u m e n S t t d ( Q 1- a r e 2 0 1 0 )
9 6 2	P h I I R h i d t a s e a : e u m a o A t h i t i r r s	M l i l d t u p e o s e, P l b t l l d a c e o c o n r o e	9 6	R i t t e c r u m e n O i ( l t n g o n g a s d h ) t t s c o o r u y
9 7 1	P h I I R h t i d A t h i t i a s e : e u m a o r r s	B T- 0 6 1 M T X + M l l i i l l d d t t p e o s e, u P l b l l d t a c e o c o n r o e	1 1 0	P t I ( i ) a r v f f i i l l i i d n a e z P I I ( ) t a r s c i o n g o n g
9 9 7	P h I I b R h i d t a s e e m a o : u A h i i t t r r s	B T- 0 6 1 M T X + M l i l d t u p e o s e, P l b t l l d a c e o c o n r o e	3 0 0 ~	S b i i m s s o n u : Q 2- 2 0 1 0

Psoriasis Phase I/IIa Study (No. 967) Results: Up to 60% of patients benefit from treatment with BT-061

PASI 50 and PASI 75 responders at day 75 after single dose in most effective dose groups**

*PASI (Psoriasis Area and Severity Index) measures the average redness, thickness and scaliness of the lesions, weighted by the area of involvement. **: each with 7 or 8 patients

Psoriasis Phase I/IIa Study (No. 967) Results: Improvement of clinical symptoms - a characteristic time course

25 mg sc

• ¾ Highest response rate (improvement of clinicals symptons) in 25 mg sc group
• ¾ Duration of clinical benefit up to 90 da ys y after single application of BT- 061

• ¾Good safety and tolerability

• * PASI (Psoriasis Area and Severity Index) measures the average redness thickness and scaliness of the lesions weighted by the Area and Index) measures redness, lesions, by area of involvement.

• ** days past treatment

BT-061: Summary clinical results Psoriasis

Psoriasis Phase I/IIa (single dose administration)

• •Highest response rates by subcutaneous administration (25 mg)
• •Duration of clinical benefit up to 90 days benefit
• •Proof-of-concept achieved in Psoriasis
• •Good safety and tolerability
• ¾Improvement of clinical symptoms and Proof-of concept in Phase I/IIa

Psoriasis Phase II (multiple dose administration)

• •Recruitment has started
• • Goals:
• −Further improvement of efficacy by repeated dosing (8 weeks)
• Finalization of dose finding/ frequence of administration
• Focus on subcutaneous administration

BT-061: Summary clinical results Rheumatoid Arthritis

Rh t id A th iti Ph II d Ph IIRheumaoidrthritis Phase IIa anPhase II:

• Phase IIa: Monotherapy: up to 70% improvement (ACR70) after 6 weeks of treatment (50 mg sc and 2 mg iv)
• Ph II ase: C bi i i h h (MTX) 70% i Combination with met hotrexate (MTX): up to improvement (ACR70) after 8 weeks of treatment (2 mg iv + MTX)
• •Proof-of concept achieved in Rheumatoid Arthritis
• •Good safety and tolerability

Rheumatoid Arthritis Phase IIb (submission Q2/2010):

• •~ 300 patients
• •Combination with MTX
• •12 weeks treatment, once per week and every other week
• •Subcutaneous administration
• • Goals:
• G t t ti ti l b i f h III Generate stati stical basis for p hase
• −Determine final dose schedule

Partnering for BT-061: Co-development and comarketing from Phase III onwards

• •Several globally acting pharmaceutical companies have been approached
• •Predominantly positive response
• •Development and marketing concept met fundamental approval
• •Principle interest in taking part in the project expressed
• • Partners req g gp g uire final data of on goin g phase II trials in order to a gree to relevant deal structure
• •Discussions ongoing

BT-062 : Clinical efficacy in Multiple Myeloma

• • BT-062: specific and highly effective immunotoxin: toxin part mediates high efficacy – antibody part mediates high specificity
• • Phase I Study: Repeated single dose, dose escalation study in patients with relapsed or relapsed/refractory Multiple Myeloma
• • Indications of efficacy already with low dosages:
  • Disease progression halted in some patients for several months
  • Clinical benefit for 53% of patients lasting 6 weeks or longer
  • Maximum treatment dose defined and cohort extension ongoing
• •Good safety and tolerability

Multiple Myeloma ⁻ unmet need and high market potential

Survival rates for MM patients in the USA

Sales of novel targeted MM therapies (in US\$ million)

⁽Source: SEER Cancer Statistics Review,1975 - 2004) (Source: Company data and Biotest analysis 2009)

BT-062: Single-Dose Study 969 in Muliple Myeloma First Efficacy Data

b f i N t t u m e r o p a e n s	l T t o a	P t e r c e n a g e	b O j i t e c v e r e s p o n s e	l l b f C i i i t n c a e n e ( ) %
d h * i B T‐ 0 6 2 t t t r e a e w	2 5
f f l b l d i i t e c a c y a a a v a a e	1 7	1 0 0 %
d i i s e a s e p r o g g r e s s o n ‐	1	6 %
d i i n o s e a s e p r o g r e s s o n ‐ k 3 > w e e s	7	% 4 1
b l d k i 6 ≥ t s a e s e a s e e e s w ‐	7	% 4 1
i m n o r r e s p o n s e ‐	1	% 6		3 % 5
l i t p a r a r e s p o n s e ‐	1	6 %	1 2 %

¾BT-062 shows anti-tumor activity already in repeated single dose schedule

¾Further patients to be enrolled in MTD** cohort up to a total of 15

*Median number of prior chemotherapies: 7 (range: 2-15); 33% of patients had 10 or more prior chemotherapies **MTD: Maximum tolerated dose; Response criteria as defined by International Myeloma Working Group

BT-062: Repeated Single Dose Study 969 in Multiple Myeloma - Baseline Characteristics

Patients have been heavily pre-treated; median age of about 65 years and about 6 years median time since initial diagnosis

• • All patients have been treated with Bortezomib and at least one Immunomodulator
• • About 75% have been pre-treated with both Lenalidomide and Thalidomide
• • More than 50% have dundergone an autologous stem cell transplantation (ASCT)

BT-062 : Next steps initiated

• • Based on positive results from Phase I study, study documents for next clinical phase I/IIa have been submitted
• • Phase I/IIa Study: Multi dose escalation study in patients with relapsed or relapsed/refractory Multiple Myeloma
• Study approved by FDA (IND*-submission)
• Trial initiation expected in Q2 2010
• •Goal: Further definition of dose schedule

^*IND = Investigational New Drug

BT-063: Phase I study on track

BT-063 lead indication

• •Systemic Lupus Erythematosus (SLE)
• • High medical need: SLE incurable today medical today, no new approval since ~ 40 years
• • 2.5 million patients are suffering from SLE worldwide today

Status Phase I

• • Dose escalation in healthy volunteers ongoing
• •21 volunteers treated
• •So far study medication well tolerated

Outlook Biotherapeutics: Next Steps in Clinical Development Initiated

BT-061:

• •First encouraging clinical data from both lead indications
• • Ph II t i l i P i i t t d Phase trial in Psoriasis starte
• •Phase IIb in RA in preparation
• •Discussion with strategic partners ongoing

BT-062:

• •First indications of efficacy from dose-escalating study
• •Multiple dose phase I/IIa trial approved by FDA
• •Study start expected Q2 2010

BT-063:

• •Phase I study approved in Sept. 2009
• •Treatment at 7th dose level completed (02 2010)

Summary Biotest Group

Outlook 2010: Outlook

• • Increase in a low single digit range - provided tender business on previous year level
• • EBIT 2010 on level of 2009 provided that there will be no further price 2009, provided be no further price reductions and stable conditions of health care systems; 2010 will be a challenging year
• • It is our assumption, that the plasma market environment will stabilise within the next 1-2 years and thereby the pricing situation
• • The initiation of operations at the production facility in Boca Raton/ US will production have a significant positive effect on Biotest
• •Biotherapeutics: well on track

International Myeloma Working Group Response Criteria

	M j h t i t i f i t i * a o r c a r c e r s c s o r e s p o n s e c r e r a
P i D i ( P D ) r o g r e s s v e s e a s e	f % f I 2 5 l t l i n c r e a s e o r o m o w e s r e s p o n s e v a u e n a n y o n e o r f t h f l l i m o r e o e o o w n g : S M ( b l i b t t t e r m -c o m p o n e n a s o e n c r e a s e m s e u u u 0. / 1 0 0 l ) d / 5 ≥ c g m a n o r ( U i M t b l t i t b 2 0 0 ≥ r n e -c o m p o n e n a s o u e n c r e a s e m u s e m g p e r 2 4 h )
S b l d i ( S D ) t a e s e a s e	f C G N t t i i t i R V P R P R i o m e e n g c r e r a o r o r p r o g r e s s v e , , d i s e a s e
M i ( M R ) i t i t i t h n o r r e s p o n s e n p a e n s w f l d t l r e a p s e r e r a c o r m e o m a y y	2 % b 4 9 % d i f M i d d i 5 t t t t ≥ < u r e u c o n o s e r u m p r o e n a n r e u c o n % % i 2 4 h i M t i b 5 0 8 8 9 9 h i h t i l l d 2 0 0 n u r n e p r o e n y w c s e x c e e s m g – , 2 4 h p e r
P t i l ( P R ) a r a r e s p o n s e	0 % d i f M P i d d i i 2 4- h 5 t t t ≥ r e u c o n o s e r u m r o e n a n r e u c o n n - % i M t i b 9 0 t 2 0 0 2 4 h ≥ < u r n a r y p r o e n y o r o m g p e r I f t t h h d d i i M M P P t t i i b b l l 5 0 % ≥ e s e r u m a n u r n e r o e n a r e u n m e a s u r a e, a - d i h d i f f b i l d d i l d t t e c r e a s e n e e r e n c e e e e n n o e a n n n o e w v v u v v F L C l l i i d i l f h M P i i i t t t e v e s s r e q u r e n p a c e o e r o e n c r e r a -
( ) M i T l t d D M T D a m m o e r a e o s e x u	T h h i h d l l h i h 2 f 6 b j i t t t < e g e s o s e e e a c o s e c s e p e r e n c e v w u x D L T ( ( D D L i i i i i T T i i i i ) ) i i d f f i i d d h h M M T T D D t t t a o s e m n g o c s e n e a s e x y
* a d ing I M W G In io l M lo W k ing G te t cc or rn a na y e m a or ro ,	So Ky le d Ra j ku 2 0 0 9; up ; ur ce : an m ar ,

Thank you for your attention!

Contact and Financial Calendar 2010

I t R l t i B i t t A G n e s o r e a o n s o e s v :	C F i i l l n a n c a a e	d 2 0 1 0 n a r
D M i k B k i t t t r. o n a e r e u H d f I R l i t t e a o n v e s o r e a o n s	M 0 0 6 6 2 0 1 0 a y , M 1 1 2 0 1 0 a y ,	A l G l M i t n n u a e n e r a e e n g Q 1 R t 2 0 1 0 e p o r
P h 4 9 ( 0 ) 6 1 0 3 8 0 1 4 4 0 6 + o n e : - - F 4 9 ( 0 ) 6 1 0 3 8 0 1 3 4 7 + a x : - - E M i l i l i @ b i d t t t t. a n e s o r_ r e a o n s o e s e : v -	A 1 1 2 2 2 0 1 0 u g , , N 0 8 2 0 1 0 o v , N 0 8 2 0 1 0 o v ,	Q 2 R 2 2 0 0 1 1 0 0 t e p o r C f A l t 's n a y s o n e r e n c e Q 3 R 2 0 1 0 t e p o r

Biotest Plasma Proteins ⁻ premium products

Intratect®

Human immunoglobulin for Th ti i di ti intravenous use (IVIG)

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Therapeutic indications:

• • Replacement therapy in:
• 1.Primary Immunodeficiency Syndromes
• 2.My yp y eloma or chronic lymphocytic leukaemia
• 1. Children with congenital AIDS and recurrent infections
• • Treatment of autoimmune diseases: ITP (idiopathic thrombocytopenic purpura) Guillain purpura), Guillain-Barré-Syndrom, and Kawasaki Syndrom

Properties:

• •St t t t Storage at room temperature
• •Well tolerated (Sugar free)
• •Ready-for-use solution

Clinical trial:

• • Phase III trial in chronic idiopathic pain syndrom completed
• • Laboratory parameters are currently evaluated to id tif di ti l t th t li k d t itiidentify predictive clusters that are linked to positive outcome

Pentaglobin® / IgM-Concentrate

IgM-enriched immunoglobulin for severe bacterial infections

Therapeutic indications:

• • Adjunctive therapy of severe bacterial infections in addition to antibiotic therapy immuno
• • Immunoglobulin replacement in immunocompromised patients

Properties:

• • U i i li i ti f th d th i Unique in elimination of pathogens and their toxins
• • Excellent immunomodulator for controlling inflammation and severe bacterial infections
• •Excellent tolerability

Clinical trial:

• I Mg -C tt oncentrate i li i l Ph I in clinical Phase I: Further developed IgM-enriched immunoglobulin

Hepatect®

Human Hepatitis B immunoglobulin manufactured from plasma of donors with high

Th ti i di tiTherapeutic indications:

• • Prophylaxis against hepatitis B (HBV) in adults and children over 2 years who have not been vaccinated and who are at risk ofanti-HBs antibody titres infection
• • Prophylaxis of HBV re-infection after liver transp (g ) lantation (gold standard)
• • Post exposure prophylaxis after exposure to HVB, e.g. needle stick injuries
• • HBV prophylaxis in newborns from HBV carrier mothers

Properties:

• •Ready-for-use solution
• •Sugar-free, isotonic low-salt solution
• • Natural function and activity of specific immunoglobulins is preserved

Cytotect®

Human CMV immunoglobulin manufactured from plasma of donors with high CMV antibody titres

Therapeutic indications:

• Prophylaxis against the clinical manifestation of CMV infections in immunosuppressed patients especially transplant recipients patients,

Properties:

• •Ready-for-use solution
• •Sugar-free, isotonic low-salt solution
• • Orphan Drug Designation for prevention and treatment of congenital CMV-infections (Europe, U.S., CH)

Clinical trial:

• • Phase III study to prevent CMV infection in children of mothers who acquired a primary CMV infection during pregnancy
• • Ongoing process to optimise recruitment and study O go g p ocess opt se ec ^u t ^e t ^a d procedures

Haemoctin® / Haemonine®

Chromatographically purified, double virus inactivated coagulation factors concentrated from plasma

Therapeutic indications:

• •Prevention and treatment of bleeding in:
• 1.Haemophilia A (Haemoctin®)
• 2.Haemophilia B (Haemonine®)

Properties:

• •High viral safety standard
• •Stable for two years at room temperature
• • Haemoctin contains a high level of von Willebrand factor (VWF)
• • Haemoctin has been shown to be efficacious in FVIII inhibitor therapy - in general VWF-containing FVIII preparations are the first choice in inhibitor treatment with high dosages of FVIII

Zutectra® − increased patient compliance

Human Hepatitis B immunoglobulin for subcutaneous administration. Manufactured from plasma of donors with high anti-HBs antibody titres.

Therapeutic indications (after approval):

• Prophylaxis of HBV re-infection after liver transplantation

Properties:

• • Subcutaneous administration – ready for lf d i i t ti b ti t se-administration by patients
• •Ready-for-use solution in pre filled syringe
• •High specific activity of 500 IU/ml
• Safe and convenient HBV re-infection prophylaxis for liver transplant patients

Cli i l t i lClinical trial:

• • Phase III study completed and submitted for a centralised European authorisation procedure
• •Approval expected end of 2009