Biotest AG — Investor Presentation 2011

Mar 22, 2011

Press and Analyst Conference – Financial Year 2010 Frankfurt/Main March 22 2011Frankfurt/Main, 22,

Disclaimer

• • This document contains forward forward-looking statements on overall economic looking 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 the forward-looking statements and assumes no obligation to looking do so.
• • All figures reported relate to the Continuing Operations of the Biotest Group. After the disposal of the transfusion and transplantation diagnostic activities to Bio Bio-Rad Laboratories Inc., these diagnostic activities are being reported as Discontinued Operation. Due to the companies intention to sell the segment of Microbiological Monitoring, these activities are also reported under "Discontinued Operation". With th ti f th t t t f fi i l iti th i the exception of the statement of financial position, the previous year´s fi h gures have been adjusted accordingly.
• • All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest Group: Highlights 2010 and Q1 2011

• •Biotest FY 2010 Group Sales up by 5.7%
• • EBIT decreased by 24 9% due to difficult plasma protein 24.9% plasma market environment
• • Microbiolog ggg p ical Monitorin g: Si gnin g of sale and purchase agreement with Merck KGaA Darmstadt, Germany
• • Submission of BivigamTM BLA to FDA on Nov. 3, 2010; first FDA inspections ongoing
• • Further milestones achieved in Plasma Proteins and Biotherapeutics
• • Transfer of Medical Diagnostics business to Bio-Rad finalized.

Biotest to sell Microbiological Monitoring business to Merck KGaA

• • Contract signed to sell worldwide activities of the Microbiological Monitoring segment to segment Merck KGaA (Darmstadt/ Germany)
• • Merck KGaA to acquire 100% of the shares of
• ¾Biotest Microbiology Corp. (Rockaway/ USA)
• ¾Biotest S.a.r.l. (Paris/ France)
• ¾Biotest K K (Yokohama/ Japan) K.K.
• ¾ heipha Dr. Müller GmbH (Eppelheim/ Germany; 51% Biotest AG, 49% Dr. Müller)
• ¾Total Hycon business of Biotest AG
• ¾ as well as the microbiology business of five European subsidiaries of Biotest Group through an asset deal

Biotest to sell Microbiological Monitoring business to Merck KGaA

• •Revenues of activities in 2010: € 48.7 million
• •290 employees work for the business segment
• • The transaction is subject to anti trust clearance and is foreseen to be closed by end of Q3 2011
• • Biotest has been advised by @visory partners and FRANZ Rechtsanwälte

Biotest : Future corporate structure

Plasma Proteins

US IVIG market development, 2007 - 2010

Source: PPTA; Estimate volumes October – December 2010 Citigroup, February 28, 2011

Biotest's expectations on IVIG volumes and prices for 2011

• • Demand for IVIG will continue to rise due to new indications, higher consumption per patient and new markets
• • Without inventory effect in 2011 volumes of IVIG offered to be sold will be 12 15 tons lower than in 2010:
• ¾ Volume of plasma being collected in 2010 in the USA was 2 – 2.5 m liters lower than in 2009
• ¾Octapharma has not yet returned to the market in EU and USA

Our previous statements have been confirmed Price stabilisation took place in key countries beginning of 2011 We estimate, that this will lead to price increases in the 2nd half of 2011

BivigamTM (IVIG) FDA filing in US

immunoglobulin

• Polyspecific BivigamTM FDA filing on Nov. 3, 2010
• FDA confirmed that BLA dossier is generally accepted; First FDA inspections took place
• Final technical fine tuning ongoing e.g. automation system
• Additional conformance lots to be produced in Q2 2011

Filing of strategic importance to Biotest Market potential ~ USD 100 m

Major progress in development of Plasma Proteins (I)

® Z t t e c r a u	T M F t o v e p a ( H t i t i s c e p a s h i l b l i y p e r m m u n o g o u n f ) t o r n e o n a e s	® C 7 0 t t t o e c y
S f l k t u c c e s s u m a r e i t d t i i n r o u c o n n G A t i I t l e r m a n y, u s r a a y, , I l d t i t r e a n ; e x e n s o n o h i i t t o e r c o u n r e s s l d p a n n e	S f t d t i l i d u y r e p o r n a s e 2 0 1 1 i F b n e P E I b i i s u m s s o n l d f A i l 2 0 1 1 p a n n e o r p r	I i l i t n e r m a n a s s y ( 1 2 / 2 0 1 0 ) i d i d l i i l f f i t n c a e c n c a e c a c y i t i t h n p r e g n a n o m e n w w f t l i t i d c o m e g a n e c o n s a n y y f f i d i t i d t c o n r m e p o s v a a o i t d i p r e v o u s s u e s

R&D expenses in 2010 in the Plasma Protein segment: € 27 9 m&D27.9

Major progress in development of Plasma Proteins (II)

I M C t t g o n c e n r a e	% I t t t 1 0 n r a e c	T M C i i v a c r	F i b i r n o g e n
P h I I i l l t t a s e r a p r o o c o b i t t d t P E I s u m e o S t d t t l d u y s a r p a n n e Q 3 2 0 1 1	P h I I I i l d t t t a s e r a s a r e F i t t i t i l d d r s p a e n s n c e u f Q 2 0 1 1 E d t d 4 n o s u y	N d t i e w p p r o u c o n h d l h b s c e u e a s e e n d i d f l i t t e e r m n e o r m u a o n , h b i d a s e e n m p r o e v f V l i d t i i a a o n o s c r e e n n g i i a s s a y s s o n g o n g	I d i i t t n c a o n : a c u e b l d i d i d e e n g s o r e r s P d t h t i t i r o c c a r a c e r s c s u f h b d i d a v e e e n e n e S f l i i l t t a r o c n c a d l t d 2 0 1 1 e v e o p m e n e n

Facility expansion to ensure further growth of Plasma Proteins

• Expansion of filling and packaging facility in Dreieich has started in Dec. 2010
• Facility expected to be finalised in 2013
• Total capex spending approx. € 25 m

Biotherapeutics

Biotherapeutics portfolio

1) Sources: company reports, Biotests estimates for 2010

Clinical development BT-061 Overview

R h i d h i i t t t e u m a o a r r s			P i i s o r a s s
T i l r a	S t t a s u		T i l r a	S t t a u s
P h I I h t a s e a, m o n o e r a p y ( N 9 6 2 ) o	C l d t o m p e e		P h I / I I a s e a, m o i l d ( N s n g e o s e	h C l d t t n o e r a p y o m p e e 9 6 7 ) o
P h I I, b i t i a s e c o m n a o n ( ) i t h M T X N 9 7 1 o w	C l t d o m p e e		P h I I, a s e m o n o ( l t i l d m p e o s e u	t h R i t t e r a p y e c r u m e n ) N 9 7 3 l t d o c o m p e e
P h I I b, b i t i a s e c o m n a o n ( ) i t h M T X N 9 7 9 w o	R i t t e c r m e n u i o n g o n g

BT-061: Rheumatoid Arthritis Phase II Study (No. 971)

Trial Design and Results

• • Repeated dose, Placebo controlled
• •European multi-center
• • Therapeutic arm: B T-061 + MTXp
• •Control arm: MTX + Placebo
• • 8 weeks treatment, once per week
• • Total patient number: 41
• •Dose-confirmation trial
• • Follow-up period 8 weeks p

Preliminary Results

• 9 Clear improvement already after only 8 weeks of treatment in relevant SC dose grou p g
• ⁹Favourable ACR results when compared to approved drugs (week 92))
• 9 F th i t ith ti d Further improvement with continue treatment expected, typical plateaus of ACR response for biologics not reached yet3) y
• 9Good tolerability

1) Methotrexate + Placebo 2) ACR50 and ACR70 describe % of patients with improvement of clinical symptoms of at least 50% or 70%, respectively 3) expected plateaus: ACR20 after 3 months; ACR50 after 4 months; ACR70 after 6 months

Rheumatoid Arthritis Phase II Study (No. 971)

Preliminary analysis: Favourable Efficacy Results

50 mg BT-061 SC + MTX ACR scores [%] at primary endpoint (week 9)

BT-061: only patients that received the complete 8 week treatment cycle were considered for calculation

1) Biotest analysis of trial results of approved biologics analysis of

Please note: Trial results (average) from independent trials are shown, which are not directly comparable as patient characteristics, route of administration, dose levels and treatment frequency are different

BT-061: Rheumatoid Arthritis Phase IIb Study (No. 979) Trial Design and Results

•Repeated dose, placebo controlled

• •International multi-center stud
• •Therapeutic arm: BT-061 + MTX
• •Control arm: MTX + Placebo
• •12 weeks treatment, once weekly
• • Total patient number: 176
• • First RA Study with confirmatory statistics

• •Follow-up period 12 weeks

• 9Submission in all countries done

• 9 First patients recruited in 12/2010
• 9Recruitment is ongoing

1) MTX + Placebo treated

y

BT-061 Partnership

BT-062: Multiple Myeloma Phase I (No. 969)

Trial Design and Results

• • Patient population Relapsed and relapsed/refractory Multiple Myeloma
• •Dose-escalation trial
• Th ti i t Therapeutic regimen
• Repeated Single Dose
• Dosing every 3 weeks
• MTD cohort consists of 13 patients

Results

• 9Maximal Tolerated Dose (MTD) identified
• 9Good tolerability
• 9 Clinical benefit in more than 50% of •heavily pretreated patients
• 9 Stable disease in some patients for several months

BT-062: Repeated Single Dose Study 969 Minor response in patient of MTD cohort

• ¾ Patient progression progression-free for more than 8month
• ¾Treatment with BT-062 ongoing

BT-062: Summary

S d t u y	D i R i o s n g e g m e n	R l t e s u s
M t h o n o e r a p y ( ) N 9 6 9 o S U A	R t d i l d e p p e a e s n g g e o s e	( ( ) ) M i t l b l d M T D a m m o e r a e o s e x u f h t d i d c o o r e n e G d t l b i l i t o o o e r a y C f % f l i i l B i t i 5 0 t i t > n c a e n e n o p a e n s , i l d i i d t i l n c u n g m n o r a n p a r a r e s p o n s e s
M h t o n o e r a p y ( ) N 9 7 5 o S U A	M l i l d t p e o s e m o r e u , i t d i h n e n s e o s n g s c e m e	G d l b i l i i f i i t t t t t o o o e r a n r s p a e n s y f f N i l t i l b l t o e c a c r e s s a a a e e y u v y
C b i i t o m n a o n h ( N 9 8 3 ) t e r a p o y E U	S l d d f t t a r p a n n e e n o 2 0 1 1	-

Financials FY 2010

Change in reporting structure 2010

All following figures reflect the ongoing business if not expressly stated otherwise

Solid revenue growth

Revenue (in € m)

• • FY Sales at € 412.5 m, a growth of 5.7% vs € 390.1 m in 2009, despite a difficult market environment
• • Sales growth largely attributable to higher sales largely volumes
• • Continuing price pressure for immunoglobulins fand clotting actors
• • Sales and earnings were reduced by approx. € 2 ^m as result of German healthcare reforms (GKV Änderungsgesetz)

Despite sales growth, EBIT decreased

EBIT (in € m)

• • Despite 5.7% sales growth, EBIT decreased by 25% 2009
• Continuing price pressure for immunoglobulins and clotting factors
• Increase in volume could not compensate negative price effect
• Unfavorable product mix: more products sold with less attractive margins: plasma, clotting factors
• • R&D expenses 5.6% higher than in 2009: Plasma Proteins: + € 2.2 mBiotherapeutics: + € 0.4 m

FY 2010: EBIT Biotest Group (€ m)

	Y 2 0 1 0 F	Y 2 0 0 9 F
l i P P t a s m a r o e n s	7 3 5	8 9 2	% 1 7 6 ‐
h i i B t t o e r a p e u c s	2 1 7 ‐	2 1 1 ‐	% 2 8 ‐
C t o r p o r a e	8 9 ‐	1 1 0 ‐	1 9 1 % +
i G B t t o e s r o p u	4 2 9	1 5 7	2 4 9 % ‐

Sharp decrease in EBIT and EBT in FY 2010

Financial result:

F i i l R l F Y 2 0 0 9 t n a n c a e s u :	€ 1 1 2 2 0 0 m -
G D i t k s c o n o n r e e u b d e r o o n s z	€ 5 6 m -
L i t t o w e r n e r e s e x p e n s e s	€ 2 7 + m
O t h e r	€ 0 1 + m
F i i l R l F Y 2 0 1 0 t n a n c a e s u :	€ 1 4 8 m -

Low EAT

EAT (in € m)

*EAT of discontinued operations

• •Tax rate 31.0% vs. FY 2009 34.8%
• • Earnings after tax (Continuing Operations and Discontinued Operation) at € 39.5 m 19.9*

E i S h a r n n g s p e r a r e : •	2 0 1 0	2 0 0 9
f P h e r p r e e r e n c e s a r e	€ 1. 7 0	€ 2 5 5

D i i d d P l A G M ** t v e n r o p o s a o	2 0 1 0	2 0 0 9
f f P P h h r e e r e n c e s a r e	€ 0 0 4 4 4 4	€ 0 0 4 4 0 0
O d i h r n a r y s a r e	€ 0 3 8	€ 0 3 4

** Annual General Meeting takes place on May, 12th 2011 in Frankfurt

Cash Flow from Operating Activities in € ^m*

FY 2010 : January – December 2010

*Continued Operations **Reduction of €24.7 m Greek trade receivables without cash impact

Outlook

Guidance 2011:

• Sales: Sales to grow with a low single digit percentage compared to 2010
• EBIT:EBIT to grow with a low single digit percentage

The guidance does not take into consideration possible earnings or income from an license agreement or our participation in another project in the Biotherapeutics segment. Also not included is any t di i f di ti d tiextraordinary income from discontinued operations.

Outlook Biotest Group

• •Growing demand for IVIG with corresponding increasing prices mid of 2011
• •Stable market for clotting factors and albumin
• • Bivi gamTM market authorisation ex p Q ( ); ected Q4 (2011); annual market potential ~ USD 100 m
• • Promising R & D pipeline for Plasma Proteins and Biotherapeutics

Thank you

for your attention!

Contact and Financial Calendar 2011

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