2010 08 CompanyPresentation

Biotest Group: Creating Value.
Living Values
Management Presentation
Biotest AG
A
August
t 2010
Company Presentation Biotest AG

Disclaimer
This document contains forward
forward-looking
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
forward looking statements and assumes no
obligation to 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-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.
Company Presentation Biotest AG 1

Biotest at a glance
Key Figures: FY 2009 H1 2010
Sales € 438.6 m (+14.2%) € 227.1 m (+4.0%)
Thereof Plasma Proteins € 390.1 m (+14.9%) € 200.6 m (+3.2%)
EBIT € 61.6 m ((+4.6%)) € 23.7 m ((-24.0%))
Business sectors
Pharmaceuticals Diagnostics
Divisions
Plasma Proteins Biotherapeutics Microbiological

Monitoring
• Immunoglobulins • Monoclonal • Hygiene
• Hyper-immuno- antibodies monitoring
globulins
• Clotting factors
• Albumin

Biotest Group
• Headquarters in Dreieich/Germany
(Frankfurt area)
• Subsidiaries in 14 countries worldwide
• E
Employees
l (FTE)*
(FTE)*: 1
1,828**
828**
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 30 June 2010 **: Continuing Operations

Headquarter, Dreieich

Biotest Group overview
European production and distribution sites Additional sites overseas:
• USA: Florida ( ), Rockaway ( )
• Japan: Tokyo ( )
• Distribution also via 138 distributors in

Dreieich (HQ)
76 countries
Sales by region (H1 2010):

N./S.
Americs;
11% RoW; 2%
Germany;
23%
Production Asia;
Sales 25% EU (w/o
GER); 39%
24. August 2010 Biotest AG 4

About Biotest – strong track record
Sales of Biotest Group (in € million)* • Strong revenue growth,

particularly in Plasma
+102% 481 Proteins business
423 • Plasma Proteins account

for 81% of Group’s sales
in 2009
326
282 • EBIT increase by 131%
238 from 2005 to 2009
2005 2006 2007 2008 2009

*: Biotest Group incl. Discontinued Operations

Shareholder structure
Biotest AG
Ordinary shares: 6.6 mio Preference shares: 5.1 mio

with voting rights no voting rights, but higher dividend
OGEL GmbH*: 50.03%

KSK Biberach*: ~24% Free Float: 100%
Free Float: ~26%
56.4% of total capital, 43.6% of total capital,

and 100% of voting rights 0% off voting
i rights
i h
* as of August 2010

Biotest: History and milestones achived
1946: Biotest- 1961: New 2007:

Serum Institut production 1987: IPO - Clinical testing
g
G bH
GmbH facility at of monoclonal
Dreieich 1991: Start of antibodies
1968: First Microbiological - Acquisition of
subsidiary Monitoring Nabi
outside Germany - Preference
(Italy) 2004: Start of share in SDAX
1948: Test- modernized
Serum Anti-D 1971: Market launch Plasma Proteins 2010: Divestment of
of Intraglobin® production Medical Diagnostics
(polyspecific
immunoglobulin)
1946 2010

Financials H1 2010

H1 2010 – At a glance
• H1 Sales increase + 4.0% to € 227.1 million in difficult market environment

• Continued influences on EBIT:
¾ further price decrease for plasma protein products
¾ continued unabsorbed costs in US (finalisation production facility Boca Raton)
¾ increased R&D expenses: € 4.1 million (+19%) incl. consistency batches at
BPC and regulatory filing for BLA BivigamTM
• H1 EBIT € 23.7 million (-24%)
• Revised EBIT Outlook

Expectations FY 2010
• Sales growth in lower single digit range
• Further
u e p price
ce p
pressures
essu es e
expected
pec ed for
o Intratect
a ec aand
d Haemoctin
ae oc
• Negative impact by German Healthcare Reform
• Continued unabsorbed costs in US (p

(production facility
y Boca Raton))
• Shifting of products in higher margin markets not successful
¾ EBIT level of 2009 will not be reached
New EBIT guidance: € 45 million +/- 10%
EBIT Guidance incl. Discontinued Operations:

€ 45 million +/- 10% plus € 18 million

Sales growth despite difficult environment
Sales of Plasma Proteins

& Microbiological Monitoring (€ m)
• Sales in the first half year of 2010
218.4 227.1 were up by 4.0% to 227.1 million
250 vs. H1 2009
+3
3.2%
%
200 • The Microbiological Monitoring
segment increased by a rate of
150 10.0 %, mainly through products
194.3 200.6
100 + 10
10.0%
0% manufactured by heipha
50
• The Group's Plasma Proteins
business grew with 3.2%
24.1 26.5
0
H1 2009 H1 2010
• Robust performance in challenging
business environment
Microbiol. Monitoring
Plasma Proteins

Sales Plasma Proteins
S l Pl
Sales Plasma Proteins H1 2009
P i H1 2009 € 194 3 m
194.3
Volume effect € 20.9 m
Price effect
Price effect € ‐14.6 m
14 6 m
Sales Plasma Proteins H1 2010

Sales Plasma Proteins H1 2010 € 200.6 m
200.6 m

EBIT Plasma Proteins H1 2010 vs H1 2009
EBIT Pl
EBIT Plasma Proteins H1 2009
P i H1 2009 € 42 7
42.7 m
EBIT from increased volume € 8.7 m
EBIT loss from reduced prices € ‐ 14.6 m
Net changes of other costs/expenses € ‐ 1.2 m
EBIT Plasma Proteins H1 2010 € 35.6 m

H1 2010: EBIT Biotest Group (€ m)
H1 2009 H1 2010
Plasma Proteins 42.8 35.6 ‐ 17 %
Biotherapeutics ‐ 8.8 ‐ 10.4 ‐ 18 %
Microbiology 2.5 3.3 + 32 %
Corporate ‐ 5.3 ‐ 4.8 + 9 %
Bi
Biotest Group
G 31 2
31.2 23 7
23.7 ‐ 24 %
24 %

Loss in EBIT due to higher R + D Expenses (€ m)
vs. 2009
2010 to 2009
EBIT H1 2010 (actual) 23.7 - 24 %
/\ R + D Plasma Proteins 2.1
/\ R + D Microbiology 0.2
/\ R + D Biotherapeutics 1.8
EBIT H1 2010 ( adjusted for
EBIT H1 2010 27 8
27.8 ‐11%
11%
increased R+D
expenses)

Reasons for increased R & D expenses
Plasma Proteins:
¾ BPC has produced IVIG consistency batches, regulatory expenses
has produced IVIG consistency batches, regulatory expenses
for preparartion of BLA submission
¾ Dreieich: Intensified development of plasma protein projects e.g.
I M C tote t and others
IgM, Cytotect and others
Bi th
Biotherapeutics:
ti
¾ 5 Clinical studies ongoing with BT‐061,BT‐062 and BT‐063
¾ Production Technology transfer of BT‐061 and BT‐062 to Boca Raton
Production Technology transfer of BT‐061 and BT‐062 to Boca Raton

Strong balance sheet
Balance sheet of the Biotest Group
A
Assets
t
(in € million)
Assets Liabilities
• Higher inventories driven
by expected growth in 2010
700 656 1
656.1 633 5
633.5 656 1 0.7
656.1 633 5
633.5
2,1
• Higher Trade receivables due to
31.5 9.0
600 higher sales volumes mainly in
the plasma proteins segment
500 322.9 308 5
308.5 269.9
308.2
400 Liabilities
300 • Increase in current financial

121.5 139.8
liabilities, primarily
200 corresponding to working capital
331.1
293.8
225 4
225.4 214 8
214.8
p
development
100
• Equity ratio as of 30 June 2010:
0
30/06/2010 31/12/2009 30/06/2010 31/12/2009 47.0% ( 31 Dec. 2009: 42.6%)
Current assets Non-current
Non current assets Current liabilities
Non-current liabilities Shareholders' equity Discont. Operations

Long term secure debt financing
Biotest Group: Maturity of financial • Total financial liabilities as of

liabilities ((€ million)) 30 June 2010: € 193.8 million
(31 Dec. 2009: € 204.5 million)
180 163.9
• Successful renewal of working capital
160 facility of € 40 million and new
140 working capital line of € 10 million
120
100
80
• Further financingg available – but at
60 higher interest rates
40 29.9
20 • Purchase price of € 45 million was
0
received on Jan
Jan. 6th 2010
<1 year > 1 year

Probable sale profit of €15.1 million after taxes (EAT)
in € million
- 25.4
45.0
- 1.5
15
- 3.0
18.1
15.1
Sale Net asset Cost of Sale profit Taxes Sale profit

price disposal restructuring
g (EBIT) ((EAT))

Outlook for 2010

Outlook for 2010
Reason for revised Guidance:

Expected negative impact from anticipated German Healthcare Reform legislation
of 5-6 million; driven by increases in mandatory rebates of additional 10% in public
sector
t and d out-patient
t ti t h hospital
it l sector
t
Transition in Global Plasma Protein market
¾ continued price pressure in some markets, slower market growth in some
territories
Revised Guidance for 2010:

Low single-digit percentage sales growth
EBIT at € 45 million +/- 10% (incl. Discontinued Operations: € 45 million +/- 10%
plus € 18 million)
Outlook statements are subject to:

Material price and volume movements on core plasma products, competitor activity, changes in healthcare regulation
and
d reimbursement
i b policies,
li i pending
di payments off G
Greece h
hospitals
i l and
d fforeign
i exchange
h rate movements

Outlook Plasma Protein Industry
¾ Volumes of collected plasma decline again; Industry consolidation

continues; overcapacities are being reduced
¾ The demand for final products continues
¾ Therefore the markets will begin to level out beginning from mid 2011
onwords; prices will stablize and the business will continue to grow

Outlook Plasma Protein Market
Biotest’s business environment fundamentally attractive:
Confidence in mid/-
mid/ long
long-term
term growth of plasma proteins products
Demand driven by:

– Favorable demographics: age, weight, time on therapy
– Better diagnosis and awareness driving increased use and higher
dosing
– Continued clinical evidence supporting
pp g new and emerging
g g indications
– Growth opportunities in industrialised countries and emerging markets
Products often life-saving treatments – long-term demand independent of

cyclical
li l effects
ff t

Further Outlook Biotest Group
• Despite difficult business environment we continue to invest into R&D

of Plasma Protein Projects and Biotherapeutics
• Full pipeline of Plasma Protein products and Biotherapeutics with a

potential to reach the market within the next years
• BPC/ USA: access to the single biggest plasma protein market
¾ Q3 2010 BLA submission of BivigamTM on track
¾ Launch of BivigamTM (IVIG) expected to take place in H2 2011
¾ Additional market potential of $ 100 million

Plasma Proteins

Plasma Proteins business at a glance
Biotest Plasma Protein p
products
• Global market share: 3%
Plasma
• Market share in relevant markets
(GER AUT
(GER, AUT, CH
CH, GRE
GRE, UK)
UK): 14%
FRACTIONATION
• Intratect® market share in
GER, AUT: > 13%, in UK, CH, I: > 10%
Immuno-
Hyper-
immuno-
Clotting
Albumin
• World market leader with Cytotect®
globulins Factors
globulins
and Varitect®
Hepatect® • Leading position with Hepatect® in
Zutectra®
Intratect®
Cytotect®
Haemoctin® Human- Europe and Nabi HBTM in USA
Pentaglobin® Haemonine® Albumin
Varitect® Biseko
Nabi HB • Zutectra ® launch in Feb. 2010
Infections, Hepatitis B Blood Albumin and • Biotest covers full value creation chain:
immune Cytomegaly coagulation protein plasma sourcing, production, distribution
deficiencies Varicella defects deficiencies
vertical
ti l iintegration
t ti lleads
d tto
= Biotest products = lead indications rationalisation and higher productivity
Major progress in development of Plasma Proteins
Zutectra® EU-wide approval

(centralised procedure)
Approvals in 13
Hepatect®CP other
th European
E countries
ti
(mutual recognition procedure)
Approvals in Germany and 10

Albiomin®
other European countries
Use in fibromyalgia patients:

Intratect® trial completed –
scientific publication finalised

Development of IVIG markets by regions
140
IVIG global market in [t]
120
100
Europa
Europe
80
USA
60
40
ROW
20
0
2007 2008 2009 2010E 2011E 2012E 2013E
• The IVIG market will continue to grow (5% p.a.), particularly by increased demand
i emerging
in i markets
k t
Source: MRB, Analyst Reports, Biotest Market Research

US source plasma collection forecast,
1996 -2013
+7 % p.a.
sma [MM litters]
+6 Mio. L
Collected Source Plas
C
Source: MRB "The Plasma Fractions market in the United States", 2007; PPTA; own estimates

Quarterly volumes of US source plasma
Source: PPTA (July 2010); Q2 2010e: Biotest AG

USA: A highly attractive market for Biotest
World’s
World s largest market
Highest per capita consumption in the world
High price levels

World market for Annual per capita consumption
immunoglobulins (in mg)
150
Rest of
World USA 100
30% 41%
50
Europe
0
29%
USA F UK GER

US manufacturing plant in operation
since end of 2009
State-of-the-art manufacturing facility at Biotest Pharmaceuticals Corp.
(BPC) in Boca Raton, Florida
Fractionation: 400,000 litres per annum

Immunoglobulin production: 1.5 tonnes per annum
Plasma collection at 11 BPC-owned plasma collection centres

BivigamTM (IVIG) development nears
successful completion
Polyspecific A polyspecific immunoglobulin

immunoglobulin with a wide comparable
p to Intratect®
indication range (incl.
antibody deficiency and
autoimmune diseases)
Clinical development:
successful conclusion of phase III
Production of stability batches

completed
Submission of approval documents

in Q3 2010, close to successful
completion
p
Sales potential after approval:

around $100 million per annum

Plasma Proteins – Efficient production network
Biotest Biotest Partners 21 plasma collection centres

Plasma donor Plasma donor Plasma donor
stations stations
L
Levell off self-sufficiency:
lf ffi i
stations
40% for standard plasma
Exchange of
intermediate products
from US to Europe
from end of 2010
Fractionation Fractionation Network increases

(400,000 litres) (1 million litres)** EBIT margin
P t V
Paste i ® (albumin)
Albiomin
Albi ( lb i )
Kryo Haemoctin® (factor VIII)
1.5 tonnes* of 4.0 tonnes of
i
immunoglobulins
l b li i
immunoglobulins
l b li * Approval
A l will
ill probably
b bl bbe granted
t d end
d off 2011
** Production in Dreieich and capacities at partners

CivacirTM: Attractive project on track
Hepatitis C Hepatitis C: frequent cause of liver

immunoglobulin for transplantations
reinfection p prophylaxis
p y
after liver transplantation
due to hepatitis C Prevalence: 5 to 10 times more frequent
than hepatitis B
CivacirTM: Project acquired as part of

Nabi Biopharmaceuticals
p takeover
Optimisation of manufacturing process,

e.g.
e g regarding consistency of neutralising
antibodies
Clinical development expected to be
continued in 2011

Biotest: A market leader in special preparations
Biotest plasma proteins in 2009: Hyperimmunoglobulins and

sales by product category special preparations are a very
attractive segment:
Stable prices
High market entry barriers
Biotest is totally self-sufficient in

hyperimmune plasma procurement
* Including special preparations (e.g. Pentaglobin®)

IgM Concentrate
Phase I clinical trial successfully completed

IgM-enriched
immunoglobulin for Phase
ase II cclinical
ca trial
a to
o sstart
a from
o mid
doof 2011
0
emergency treatment of
serious bacterial infections Very high functional activity
(sepsis)
G d ttolerability
Good l bilit
Improved raw material utilisation

Cytotect®: Trial is progressing
Prevention of prenatal
cytomegalovirus infection of International phase III clinical trial to
unborn children whose mothers demonstrate efficacy
were infected for the first time
during the pregnancy
Extensive immune screening under
way (up to 20,000 tests)
More than 5,000 pregnant women

tested so far
Interim evaluation planned

for end of 2010

Zutectra®: EU-wide approval of first hepatitis B
immunoglobulin for subcutaneous administration
Hepatitis B reinfection EU-wide approval of new form of

prophylaxis after a liver
administration for hepatitis B
t
transplantation
l t ti
immunoglobulin
Administered subcutaneously
(under the skin)
Fast,
F t pain-free,
i f simple
i l and
d safe
f
Developed
p for self-treatment

Hepatect® CP and Zutectra®
are an ideal combination
Reinfection prophylaxis
proph la is
after a liver trans-
plantation due to
hepatitis B infection
Hepatect® CP: Zutectra®:

Administered intravenously Optimal for self-treatment
Optimal for intensive treatment Suitable for long-term
long term
during and immediately after prophylaxis as administered
transplantation subcutaneously

Biotest R&D activity in Plasma Proteins
Hepatitis
p B immunoglobulin
g ((subcunaneous/ intramuscular))
in neonates
Ph
Phase III trial
ti l
• Status: Recruitment completed

• Final Draft of Study Report Dec. 2010
• Marketing Approval: aiming for marketing approval in Germany first,
first
international marketing authorisations to follow

Further growth of immunoglobulin market expected
Demand growth driven by 150
IVIG usage [mg] per capita

• Favorable demographics: age, weight 100
• Improved diagnosis, higher dosing level and longer

time on therapy 50
• Continued clinical evidence supporting established
and new indications 0
• Geographical expansion
Biotest well positioned by diversified portfolio
• Intratect® – a premium product concerning Source: Global Insight, MRB, PPTA, APFA
t l bilit *
tolerability
• IVIG available in US 2011
• Speciality Hyperimmunoglobulines:
Hepatect®, Zutectra®, Varitect®, Cytotect®
• sc application: Zutectra®
• Biotest is world market leader in hepatitis B
Hyperimmunoglobulin
*: 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

Opportunities in Haemophilia market
10
Increasing global standards of care
FVIII usage [IU] per capita

8
• Improving access to care Opportunity
• IIncreasing
i global
l b l penetration
t ti off 6
Emerging
hemophilia therapy 4 Markets
• Optimization of compliance, dosing and 2
prophylaxis treatment 0
Biotest Products
• Haemonine® (Factor IX) introduced in
Source: WFH, PPTA
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

Biotest R&D activity in Plasma Proteins
• R&D expenses in 2009 in the Plasma Protein segment: € 25.7

25 7 million; in
H1 2010: € 14.8 million
• Continuous 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

Biotherapeutics
p

Biotherapeutics: Attractive development projects
BT-061: BT-062: BT-063:

Rheumatoid Multiple myeloma Systemic lupus
arthritis, erythematosus
plaque psoriasis
Indications with a high medical need for effective and

tolerable treatments
Antibodies with specific mechanism of action

Biotherapeutics: Focused research
Biotherapeutics: Focused research

• High medical need R&D expense – Biotherapeutics
(in € million)
• Rapidly
p yg growing
g markets
• Blockbuster potential
Cap on Biotherapeutics R&D budget
Lead indications 21.5

+ 25% 20.7
9.8 + 17% + 4%
BT-061 Rheumatoid Arthritis, 16.6
Psoriasis 14 2
14.2
+ 45%
9.8
BT-062 Multiple Myeloma
BT-063 Systemic Lupus

Erythematosus
2006 2007 2008 2009 2010e

Biotherapeutics: Significant project progress
in financial year 2009 and 2010
Pre-clinical
Research Phase I Phase II Phase III
phase
BT 061
BT-061
Rheumatoid arthritis
Plaque psoriasis
Upside indications
BT-062
Multiple myeloma*
Solid tumour indications
BT-063
2009
SLE 2010
* Phase I/IIa clinical trial approved by FDA (IND)

Biotherapeutics: Continuously growing market potential
CAGR*::
CAGR 13% 13% 18% 14%
20
17.8
$)
e (bn US$
15 2008
2012
et volume
10
7.8
Marke
10 3
10.3
5 4.7
2.0
2.9 39
3.9
0 1.1
Rheumatoid Psoriasis Multiple Systemic
Arthritis Myeloma Lupus
*Quelle: Datamonitor, Decision Resources, Biotest Erythematosus
*CAGR: Compound Annual Growth Rate

BT-061 − Specific mode of action addressing key
regulatory function of the human immune system
Mode of action offers significant potential in several upside indications

Rheumatoid Arthritis: Competitive market environment
Favourable positioning is key to success
Cytokine neutralizing Targeting B cells or T cells Targeting Tregs: BT‐061

(TNFα and others)
MoA1) Neutralization of cytokines

of cytokines Depletion/inactivation of immune
of immune Selective activation of Tregs
activation of Tregs
cells
Weakness/ • Black box warning: • Black box warning for PML2) • Late market entry requires
Threats* risk of infection and • Increased risk of infection clear USP3) and positioning
malignancy • B‐cell depletion (up to 1 yr)
B‐cell depletion (up to 1 yr)
• FDA alert for: invasive fungal • Severe infusion reactions
infections and increased risk
of lymphoma in children
Strength/ • Market dominance
Market dominance • Treatment of TNF non
of TNF non • Superior efficacy
Superior efficacy expected
Opportunity* • Broad safety database responders • Mode of action supports
good safety profile (no
signs of immunosuppression,
cytokine release or
cytokine release or
lymphocyte depletion)
Positioning of BT-061 by new MoA, which translates into superior efficacy and
safety
1) Mode of Action 2) Progressive multifocal leucoencephalopathy 3) Unique selling point *) with respect to individual compounds

Current clinical data support targeted product
Positioning clear proof-of-concept in both indications
Rheumatoid Arthritis Psoriasis

Proof of Concept (POC) Proof of Concept (POC)
Ph
Phase II (No.
(N 962 und d 971):
971) Ph
Phase I/IIa
I/II (No.
(N 967):
967)
Mono- and Combinationtherapy • up to 88% improvement of clinical
• up to 70% improvement of clinical symptoms (PASI)
symptoms (ACR70) • long duration of therapeutic effect
• goodd tolerability
t l bilit ( to
(up t 90 days
d after
ft single
i l administration)
d i i t ti )
• Study 962: Final data available • good tolerability
• Study 971: Final data expected in Q4 2010 Study completed
Potential
ote t a to pos
position
t o BT-061
06 via
a
• efficacy
• safety
• convenient administration
(self-administration, every other week, 1 ml subcutaneously)

BT 061 in Chronic Plaque Psoriasis:
BT-061
PASI50 and PASI75 responses after single application
0.5 mg iv 0.5 mg iv 0.5 mg iv 2.5 mg iv 2.5 mg iv
80 improvement of
clinical symptoms (%)
60
40
20
nt (%)
0
mprovemen
-20
2.5 mg iv 25 mg sc 25 mg sc 25 mg sc day 0
day 5
PASI im
80 day 7
60 day 14
day 21
40 day 28
day 42
20
day 56
0 day 75
day 90
Duration of clinical benefit up to 90 days – basis for commercial schedule
Repeated treatment of RA patients with BT-061(monotherapy)
Benchmarking against gold standard of biologic therapy*
ACR responses at week 7, monotherapy

70
60 67
50
atients
40 47
41
% of pa
30 33 33 ACR20
20 ACR50
20
10 17 ACR70
10 14 13 7
7 0 0 7 0 10 2 1
0
BT-061 Placebo1) BT-061 Placebo 1) anti-TNF
Humira Placebo
efficacious dose range most efficacious dose marketed dose 3)

(50-100 mg SC)2) (50 mg SC)
(n=15) (n=10) (n=6) (n=14)
1) Two patients from each completed SC dose group; 2) Only patients that received all treatments over the 6 week periode
3) Phase III trial results of anti‐TNF monotherapy in DMARD non‐responders at week 7 *) Please note: data from independent trials are not directly
comparable as patient characteristics, route of administration, dose levels and treatment frequency are different
May 2010 Biotest AG 54

BT-061: Goals of clinical trials starting in 2010
Higher patient numbers to confirm product profile seen in early trials
Psoriasis, Phase II (973)

Goals:
− Increase efficacy by completion of dose finding and repeated administration
− Benchmarking with biologics gold standard
Design:
D i 48 patients
ti t iin 6 d
dose groups, 8 weeks
k ttreatment,
t t 12 weeks
k ffollow-up
ll
Rheumatoid Arthritis,
Arthritis Phase IIb (979)
Goals:
− Confirm/establish superior efficacy and tolerability with larger patient basis
− Establish Proof-of-Differentiation
Design: 175 patients in 3 dose groups, 12 weeks treatment, 12 weeks follow-up

Clinical development BT-061
Overview
Study Indication Design Subjects/ Status

no. Patients
Planned
single dose Study
961 Healthy volunteers 57
iv; and sc up to 180 mg completed
967 Phase I/IIa:Psoriasis single dose, 55 Study

placebo controlled iv and sc completed
973 multiple dose, Recruitment
Phase II: Psoriasis 48
placebo controlled ongoing
Phase IIa: Rheumatoid Multiple dose, Study

962 96
Arthritis Placebo controlled completed
971 Phase II: Rheumatoid Arthritis BT-061 + MTX 110 Recruitment

Multiple dose,
dose completed
Placebo controlled
979 Phase IIb: Rheumatoid BT-061 + MTX 175 Submitted to
Arthritis Multiple dose, regulatory
Placebo controlled authorities

Biotherapeutics: Established own production
capacities
Development structures in the segment:
GMP production of monoclonal antibodies

established in Boca Raton (BPC)
( )
Manufactured first large-scale batches of
BT-061 in own production facility
Start of GMP production of BT-062 at BPC in
2011

BT-061 partnership
Negotiations with international

pharmaceutical companies ongoing
High level of interest
Request for confirmation of positive trial

results via further phase II clinical trials
Biotest strategy:
Stand-alone further development of mAb
Cooperation with partner
f
from clinical
li i l phase
h III
until agreement is reached

Competitive edge BT-062: Intrinsic properties
provide basis for product positioning
Toxin moietyy mediates high

g efficacy
y Antibody moiety mediates high specificity
• High potency independent of patient´s • Unique targeting to CD138

immune system • CD138 highly overexpressed in MM and other
• Toxin technology gy with best track record: cancer cells
Sanofi Aventis, Biogen Idec, Bayer, • CD138 not expressed on bone marrow
Roche/Genentech amongst licensees stroma cells
• First filing of TAP1) mAb expected in 2010 • Good tolerability up to 160 mg/m2
((Genentech))
1) TAP: Tumor activated payload

BT-062 competitive edge: Specificity and high potency
provide potential for competitive positioning
Small molecules mAbs Immunoconjugate BT-062

MoA1) Unspecific cellular toxicity Specific cellular target Specific targeting combined with
high potency drug
Weakness/ AEs in > 30% of p

patients • Dependent
p on patients
p • Limited safetyy data basis
Threats • Myelosuppression immune system
• Thromboembolic events/ DVT2) • Broad tissue expression/
• Peripheral neuropathy potential cross reactivity
• Gastrointestinal AEs3)
Strength/ • Dominant market position • High specificity • High potency independent from
Opportunity • Validated targets patient's immune system
• Comprehensive safety data • High specificity
base • No myelosuppression and liver
toxicity expected
1) Mode of Action 2) Deep Vein Thrombosis. 3) Adverse events

BT-062: Single-dose study 969 in Multiple Myeloma
First efficacy data, August 2010
Number of patients Total Percentage Objective Clinical benefit

response (%)
treated with BT 062*
treated with BT‐062* 32
efficacy data available 25 100%
‐ disease p
progression
g within 6 11 44%
weeks
‐ stable disease ≥ 9 weeks 12 48%
56%
‐ minor response
minor response 1 4%
8%
‐ partial response 1 4%
¾ BT-062 shows anti-tumor activity already in repeated single dose schedule

¾ Further patients were enrolled in MTD** cohort up to a total of 13
*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
Prior Therapies
• All patients have been
treated with Bortezomib
and at least one
Immunomodulator
• About 70% have been
pre-treated with both
Lenalidomide and
Thalidomide
• More than 50% have
undergone
d an
autologous stem cell
transplantation (ASCT)

BT-062: Next steps
Establishment of commercial treatment schemes
Phase I/II: Repeated Dosing / Monotherapy – USA (Recruitment started August 2010)
Goals:
− Selection of commercial treatment scheme
− Establish Proof-of-Differentiation in mono therapy
g
Design:
− Up to 70 patients, open label escalation study with intensified dosage scheme
− Extension cohort of up to 29 patients
Phase II: Repeated Dosing / Combination – Europe (Planned start: 2011)

Goal: Establish Proof-of-Differentiation in combination therapy
Design: Open label combination study
Due to lower number of pre

pre-treatments,
treatments, patients are expected to show improved
response rate and longer duration of benefit

BT-063: Phase I study on track
BT-063 lead indication

• Systemic Lupus Erythematosus (SLE)
• High medical need: SLE incurable today
today,
no new approval since ~ 40 years
• 2.5 million patients are suffering from SLE
worldwide todayy
Status Phase I
• Dose escalation in healthy volunteers
ongoing
• 23 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
Phase II trial
t i l in
i PPsoriasis
i i started
t t d
• Phase IIb in RA initiated
• 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 initiated
BT 063
BT-063:
• Phase I study approved in Sept. 2009
• Treatment at 7th dose level completed (02 2010)

Microbiological Monitoring

Segment continues to be successful
H1 2010 revenue growth of 10

10.0%,
0% achieved mainly by heipha
heipha, but
also Biotest HYCON products contributed to the growth
Expansion of logistics capacities at heipha in Eppelheim
Investment in research and development

p
Strengthening of sales structures in the United States and Japan

Thank you for your attention!

Contact and Financial Calendar 2010/2011
Investor Relations Biotest AG: Financial Calendar 2010/ 2011
Dr. Monika Buttkereit

Nov 08
08, 2010 Q3 Report 2010/
Head of Investor Relations
Analyst's Conference
Phone: +49 (0) 6103 - 801 -4406
Mar 22, 2011 FY 2010/
Fax: +49 (0) 6103 - 801 -347
E-Mail: investor_relations@biotest.de Analyst conference
May 10, 2011 Q1 Report 2011
May 12, 2011 Annual General Meeting
Aug 11, 2011 Q2 Report 2011
Nov 10, 2011 Q3 Report 2011/
Analyst conference

Biotest Plasma Proteins − premium products

Intratect®
Human immunoglobulin for Therapeutic

Th ti indications:
i di ti
intravenous use (IVIG) • Replacement therapy in:
1. Primary Immunodeficiency Syndromes
2. Myeloma
y or chronic lymphocytic
y p y leukaemia
3. Children with congenital AIDS and recurrent
infections
• Treatment of autoimmune diseases:
ITP (idiopathic thrombocytopenic purpura),
purpura) Guillain-
Barré-Syndrome, and Kawasaki Syndrome
Properties:
• Storage
St att room temperature
t t
• Ready-to-use solution
• Well tolerated (Sugar free)
Clinical trials:
• Patients with a primary antibody deficiency
• Patients with idiopathic thrombocytopenic purpura
(ITP)

Pentaglobin® / IgM-Concentrate
IgM-enriched immunoglobulin Therapeutic indications:
for severe bacterial infections • Adjunctive therapy of severe bacterial
infections in addition to antibiotic therapy
• Immunoglobulin replacement in immuno-
immuno
compromised patients
Properties:
• Unique
U i iin elimination
li i ti off pathogens
th andd th
their
i
toxins
• Excellent immunomodulator for controlling
inflammation and severe bacterial infections
• Excellent tolerability
Clinical trial:
• IgM-Concentrate
I MC t t in
i clinical
li i l Ph
Phase II:
Further developed IgM-enriched
immunoglobulin

Hepatect® CP
Human Hepatitis B Therapeutic

Th ti indications:
i di ti
immunoglobulin manufactured • Prophylaxis against hepatitis B (HBV) in
from plasma of donors with high
adults and children over 2 years who have
anti-HBs antibody titres
not been vaccinated and who are at risk of
infection
• Prophylaxis of HBV re-infection after liver
transplantation
p (g
(gold standard))
• Prophylaxis after exposure to HBs Antigen
positive material, e.g. needle stick injuries
• HBV prophylaxis in newborns from HBV
carrier mothers
Properties:
• Contains high purity anti
anti-HBs
HBs antibodies
antibodies,
standardised to 50 IU/ml
• Ready-to-use infusion solution, sugar-free
• Natural function and activity of specific
immunoglobulins is preserved

Cytotect®Biotest
Human CMV immunoglobulin Therapeutic indications:

manufactured from plasma of • Prophylaxis against the clinical manifestation
donors with high CMV antibody of CMV infections in immunosuppressed
titres
patients especially transplant recipients
patients,
Properties:
• Contains anti-CMV antibodies, standardised
to 50 U/ml with reference to the standard of
the Paul-Ehrlich-Institute
• Natural function and activity of specific
i
immunoglobulin
l b li iis preserved
d
• Ready-to-use solution, sugar-free
Clinical trial:
• Phase III study to prevent CMV infection in
newborns of mothers who acquired a primary
CMV infection duringgppregnancy
g y
• Orphan Drug Designation (Europe, U.S., CH)

Haemoctin® / Haemonine®
Chromatographically purified, Therapeutic indications:

double virus inactivated
coagulation factors
• Prevention and treatment of bleeding in:
concentrated from plasma 1. Haemophilia A (Haemoctin®)
2. Haemophilia B (Haemonine®)
Properties:
• High viral safety standard
• Stable for two years at room temperature
• Haemoctin contains a high
g 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.
FVIII

Zutectra® − increased patient compliance
Human Hepatitis B
immunoglobulin for Therapeutic indication:
subcutaneous administration. • Prophylaxis of HBV re-infection after liver
Manufactured from plasma of
transplantation
donors with high anti-HBs
antibody titres.
Properties:
• Subcutaneous administration – ready for
self-administration
lf d i i t ti b by patients
ti t
• Ready-to-use solution in pre filled syringe
• High specific anti-HBs activity of 500 IU/ml
Safe and convenient HBV re-infection
prophylaxis for liver transplant patients
Clinical
Cli i l results:
lt
First subcutaneous • Protective anti-HBs-serum levels achieved
injectable HBIG for self- in all patients in the registration trial with
administration weekly Zutectra ® applications,
applications no HBV re-
infection occured
International myeloma working group
response criteria
Major charcteristics of response criteria*
Progressive Disease (PD) Increase of 25% from lowest response value in any one or
more of the following:
Serum M-component (absolute increase must be
≥0.5g/100ml)c and /or
Urine M-component (absolute increase must be ≥ 200 mg per
24 h)
Stable disease (SD) Not meeting criteria for CR, VGPR, PR or progressive
disease
Minor response (MR) in patients with ≥25% but <49% reduction of serum M protein and reduction
relapsed refractory myeloma in 24 h urine M protein by 50–89%,
50 89% which still exceeds 200mg
per 24 h
Partial response (PR) ≥50% reduction of serum M-Protein and reduction in 24-h
urinary M protein by ≥90% or to <200 mg per 24 h
If the
th serum and d urine
i M-Protein
M P t i are unmeasurable, bl a ≥50%
decrease in the difference between involved and uninvolved
FLC levels is required in place of the M-Protein criteria
Maximum Tolerated Dose (MTD) The highest dose level at which < 2 of 6 subjects experience
a DLT (Dose
(D Li
Limiting
ii T Toxicity)
i i ) iis d
defined
fi d as the
h MTD
MTD.
* according IMWG, International Myeloma Working Group; Source: Kyle and Rajkumar, 2009;
Plasma Proteins: Production process
Virus Safety
1. Plasma Sourcing
Plasmapheresis: Plasma Donor selection
collection Testing of donations
2. Fractionation
From Plasma y
Cryo
Vi
Virus removall
to intermediates Paste II, III Virus removal
Paste V
3. Purification
Virus inactivation
From Intermediates to Final Bulk Virus inactivation
4. Filling and Packaging

Biotest is a mayor player in Hepatitis B
Immunoglobulin (HBIG) market
HBIG Market worldwide • Use of HBIG after transplantation is
(i.m. & i.v.) in $ mandatory
• Biotest is world wide market leader with

Hepatect® in Europe and
Others 20%
Nabi HBTM in USA
Octapharma 1% • Zutectra® enhances Biotest

competence and engagement in the
CSL Limited 3%
Biotest HBIG market
Grifols 2% 51%
Kedrion 5% • Z t t ® will
Zutectra ill strengthen
t th and
dddefend
f d currentt
strong market position by preventing
Korea Green possible switch to i.m. and future i.v. drugs
Cross 6%
T l
Talecris
i 12% • Further
F th Launches
L Z t t ® and
h ffor Zutectra dNNabi
bi
HBTM already scheduled in attractive world
wide markets
(Marketing Research Bureau, Inc.)

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Biotest Group: Creating Value.

Company Presentation Biotest AG

Company Presentation Biotest AG 1

Plasma Proteins Biotherapeutics Microbiological

Company Presentation Biotest AG 2

• Subsidiaries in 14 countries worldwide

• Founded in 1946,, IPO in 1987,, SDAX in 2007

*: as of 30 June 2010 **: Continuing Operations

Company Presentation Biotest AG 3

• USA: Florida ( ), Rockaway ( )

• Distribution also via 138 distributors in

Sales by region (H1 2010):

24. August 2010 Biotest AG 4

Sales of Biotest Group (in € million)* • Strong revenue growth,

423 • Plasma Proteins account

2005 2006 2007 2008 2009

Company Presentation Biotest AG 5

Ordinary shares: 6.6 mio Preference shares: 5.1 mio

OGEL GmbH*: 50.03%

Free Float: ~26%

56.4% of total capital, 43.6% of total capital,

Company Presentation Biotest AG 6

1946: Biotest- 1961: New 2007:

Company Presentation Biotest AG 7

Company Presentation Biotest AG 8

• H1 Sales increase + 4.0% to € 227.1 million in difficult market environment

Company Presentation Biotest AG 9

• Sales growth in lower single digit range

• Negative impact by German Healthcare Reform

• Continued unabsorbed costs in US (p

• Shifting of products in higher margin markets not successful

¾ EBIT level of 2009 will not be reached

New EBIT guidance: € 45 million +/- 10%

EBIT Guidance incl. Discontinued Operations:

Company Presentation Biotest AG 10

Sales of Plasma Proteins

Company Presentation Biotest AG 11

Sales Plasma Proteins H1 2010

Company Presentation Biotest AG 12

Company Presentation Biotest AG 13

Company Presentation Biotest AG 14

Company Presentation Biotest AG 15

Company Presentation Biotest AG 16

300 • Increase in current financial

Company Presentation Biotest AG 17

Biotest Group: Maturity of financial • Total financial liabilities as of

Company Presentation Biotest AG 18

Sale Net asset Cost of Sale profit Taxes Sale profit

Company Presentation Biotest AG 19

Company Presentation Biotest AG 20

Reason for revised Guidance:

Revised Guidance for 2010:

Outlook statements are subject to:

Company Presentation Biotest AG 21

¾ Volumes of collected plasma decline again; Industry consolidation

¾ The demand for final products continues

Company Presentation Biotest AG 22

Biotest’s business environment fundamentally attractive:

 Demand driven by:

 Products often life-saving treatments – long-term demand independent of

Company Presentation Biotest AG 23

• Despite difficult business environment we continue to invest into R&D

Demand driven by:

Products often life-saving treatments – long-term demand independent of

Highest per capita consumption in the world

High price levels

Fractionation: 400,000 litres per annum

Polyspecific A polyspecific immunoglobulin

Production of stability batches

Submission of approval documents

Sales potential after approval:

Biotest Biotest Partners 21 plasma collection centres

Fractionation Fractionation Network increases

Hepatitis C Hepatitis C: frequent cause of liver

CivacirTM: Project acquired as part of

Optimisation of manufacturing process,

High market entry barriers

Biotest is totally self-sufficient in

Phase I clinical trial successfully completed

Improved raw material utilisation

More than 5,000 pregnant women

Interim evaluation planned

Hepatitis B reinfection EU-wide approval of new form of

Indications with a high medical need for effective and

Antibodies with specific mechanism of action