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Biotest AG — Investor Presentation 2010
May 31, 2010
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Investor Presentation
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Biotest Group: Creating Value. Living Values
Management Presentation Biotest AG
M 2010ay
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 e g r e s y u : |
F F Y Y 2 0 0 9 |
Q 1 2 0 1 0 |
|---|---|---|
| S l a e s T h f P l P i t e r e o a s m a r o e n s E B I T |
€ 4 4 0 2 m ( % ) 1 4. 1 + € 3 9 0. 1 ( 1 4. 9 % ) m + € 6 1 5 m ( 4. 2 % ) + |
€ 1 1 0 5 m ( % ) +5 2 € 1 0 1. 9 ( 4. 6 % ) m + € 1 2 3 m (- 1 8. 0 % ) |
Business sectors
Biotest Group
- • Headquarters in Dreieich/Germany (Frankfurt area)
- •Subsidiaries in 11 countries worldwide
- • E l (FTE)* 1 831** Employees (FTE)*: 1,831** 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 March 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 (Q1 2010):
About Biotest – strong track record
Sales of Biotest Group (in € million)*
- • 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
*: Biotest Group incl. Discontinued Operations
Shareholder structure
| G B i t t A o e s |
||
|---|---|---|
| O d i h 6 6 i r n a r s a r e s m y : i t h t i i h t o n g r g s w v |
P f h 1 i 5 o 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 5 0 0 3 m S : % K K B i b h 2 4 e r a c ~ F F l t 2 6 % r e e o a : ~ |
% F F l t 1 0 0 r e e o a : |
|
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 May 2010
Biotest: History and milestones achived
| 1 9 4 6 B i t t o e s : S I t i t t e r u m n s u G b b H H m 1 9 4 8 T t : e s S A i- D t e r u m n |
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 6 8 F i t : r s b i d i s u s a r y t i d G o u s e e r m a n y ( ) I t l a y 1 9 7 1 M k h ® l t : a r e a u n c f I t l b i o n r a g o n ( f l i i p o s p e c c y ) i l b l i m m u n o g o u n |
1 9 8 I P O 7 : 1 9 9 1 S f t t : a r o 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 t t f a r o : d i d m o e r n e z P l P i t a s m a r o e n s d i t p r o u c o n |
2 0 0 7 : C l i i l t t i 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 A i i i f t c q u s o n o - N b i a f P r e e r e n c e - S h i D A X s a r e n f 2 0 1 0 D i t t e s m e n o : v M d i l D i t i e c a a g n o s c s |
|---|---|---|---|
| 1 9 4 6 |
2 0 1 0 |
Financials Q1 2010
Q1 2010 – The Highlights
- Q1 Sales increase + 5.2% to € 115.0 million ; increase of R & D expenses by € 3.5 million (+34%), EBIT € 12.3 million (-18%)
- Earnings af( O ) ter tax (incl. Discont. Operations)€ 22.6 million including the extraordinary income of the sale of Medical Diagnostics
- Plasma protein production in US: stability batches of Bivigam TM (IVIG) completed
- First sales of Zutectra®
- Biotherapeutics: clear indications of clinical efficacy of BT-061 in Psoriasis in a Ph I/II t i lPhase I/IIa trial
Medical Diagnostics sold to Bio-Rad
- Sale of transplantation and transfusion diagnostic activities
- Buyer: Bio-Rad Laboratories, Inc.
- Contract signed: 23 October 2009
- Closing on 6 January 2010
- Sale price: €45 million
- P li i l dPreliminary sales procee ds: €18.1 million (EBIT)
- Pr eliminary EAT: €15.1 millione ay 5
Transaction comprised:
- Biotest Medical Diagnostics GmbH
- Biotest Diagnostics Corp.
- Activities of international affiliates
Probable sale profit of €15.1 million after taxes (EAT)
in € million
Sales growth despite difficult environment
Sales of Plasma Proteins & Microbiological Monitoring (€ m)
- • Sales in the first quarter of 2010 were up by 5.2% to 115.7 million vs. Q1 2009
- • The Microbiological Monitoring +4.6% segment grew at a rate of 10.1%, maily through products manufactured by heipha heipha
- • The Group's Plasma Proteins buiness grew with 4.6%
- • Leading position of Biotest products in several European countries
Sales Plasma Proteins
| l l S i Q 2 0 0 9 P P 1 t a e s a s m a r o e n s |
€ | 9 7 4 m |
|---|---|---|
| l f f V t o u m e e e c |
€ + |
1 2 2 m |
| f f P i t r c e e e c |
€ ‐ |
7 7 m |
| l l S i Q 2 0 0 P P 1 1 t a e s a s m a r o e n s |
€ | 0 9 1 1 m |
EBIT Plasma Proteins Q1 2010 vs Q1 2009
| l i Q 2 0 0 9 E B I T P P 1 t a s m a r o e n s |
€ | 9 8 1 m |
|---|---|---|
| f l i E B I T r o m n c r e a s e v o u m e |
€ + |
5 7 m |
| l f d d E B I T i o s s r o m r e c e p r c e s u |
€ ‐ |
7 7 m |
| / h f h N t t t e c a n g e s o o e r c o s s e x p e n s e s |
€ + |
0 2 m |
| l i Q 2 0 0 E B I T P P 1 1 t a s m a r o e n s |
€ | 8 0 1 m |
Q1 2010: EBIT Biotest Group (€ million)
| Q 1 2 0 0 9 |
Q 1 2 0 1 0 |
||
|---|---|---|---|
| P l P t i a s m a r o e n s |
1 9 8 |
1 8 0 |
9 % - |
| B i t h t i o e r a p e u c s |
3 7 - |
5 1 - |
% 3 8 - |
| M i b i l i l c r o o o g c a M i i t o n o r n g |
1 3 |
1 7 |
3 1 % + |
| C t o r p o r a e |
2 4 - |
2 3 - |
4 % + |
| G B i t t o e s r o u p |
1 5 0 |
1 2 3 |
% 1 8 - |
Lower EBIT due to higher R & D Expenses (€ million)
| 2 0 1 0 |
2 0 0 9 t o |
|
|---|---|---|
| E B I T Q 1 2 0 1 0 ( l ) t a c a u |
1 2 3 |
% 1 8 - |
| R & D P l P i t / \ a s m a r o e n s |
2 0 |
|
| R & D M i b i l / \ c r o o o g y |
0 1 |
|
| & R D B i t h t i / \ o e r a p e u c s |
1 4 |
|
| Q 2 0 0 E B I T 1 1 ( d j d fo te a us r in d & R D cr ea se ) ex p en se s |
8 1 5 |
3 % 5 + |
Reasons for increased R & D expenses
PlasmaProteins:
¾ BPC has prod d uce IVIG consi ts tency bth a tches
Biotheraputics:
¾5Clinical studies ongoing with BT‐061,BT‐062 and BT‐063
Microbiology:
¾ Dl t eve opmen of new pyro dt t e tecsys tems
Decrease in profit in Q1 2010 Strong increase in Profit incl. Discont. Operations
EBT and EAT and EAT incl. Disc. Operations (in € million)
Strong balance sheet
Balance sheet of the Biotest Group
636 9 633 5Assets Liabilities 636 9 633 5 2,1 31,5 96007000.6636.9633.5 636.9633.5310.6308.2297.7 269.9 400500324.2 293.8119.1 139.8 200300 current pment 219.5 214.80100Current assets Non-current assets Current liabilities 46.7% ( 31 Dec. 2009: 42.6%) 31/03/2010 31/12/2009 31/03/2010 31/12/2009 Non-current liabilitiesShareholders' equity Discont. Operations
(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 liabilities, primarily corresponding to working capital develop
- •Equity ratio as of 31 Mar. 2010:
Long term secure debt financing
Biotest Group: Maturity of financial liabilities (€ million)
- • Total financial liabilities as of 31 March 2010: € 184.8 million(31 Dec. 2009: € 204.5 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 2010
Outlook for 2010
Outlook for 2010
Bi t t' b i i t f d t ll tt ti d t blotest's business environmenfundamenally attractive an d sable:
- Products often life-saving treatments – long-term demand independent of cyclical effects
- Bi t t' b i i i ll di ifi d otest's business is regionally diversifi e
- Growth opportunities in industrialised countries and emerging markets
But there are grounds for caution:
- Difficult funding situation of public sector healthcare systems
- Higher credit and default risks in some markets
Our targets for 2010:
- Low single-di g gg it percenta ge sales growth
- EBIT at 2009 level
Prerequisite:
No further price decreases
More sales in high-margin markets
Plasma Proteins
Our strategy for Plasma Proteins: Expand position as specialist in innovative immunology and haematology
- Develop new preparations, approvals in further indications
- Open up new international markets
- Demand-based development of capacities
Major progress in development of Plasma Proteins
Zutectra® Europe-wide approval (centralised procedure)
Approvals in seven Hepatect th E t i ®other European coun ries(mutual recognition procedure)
®
®
Intratect
Approvals in six other European countries Albiomin
Use in fibromyalgia indication: trial completed – scientific publications finalised
Plasma Proteins business at a glance
PlasmaFRACTIONATIONImmunoglobulins Hyper- immuno- globulins Clotting Factors Albumin Human-AlbuminBisekoHaemoctin®Haemonine®Hepatect ®Zutectra®Cytotect ®Varitect®Nabi HBIntratect®Pentaglobin ®Albumin and protein deficienciesBlood coagulation defectsHepatitis B Cytomegaly VaricellaInfections, immune deficiencies= Biotest products = lead indications
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: Impressive growth
Plasma Proteins: revenue (in € million)
D l t f l l i th U it d St t Developmen t of plasma supply in the nite ates 2008/2009
V l f US d l (i illi lit ) Volume oUS-source
- Adjustment of US-sourced plasma volumes to changed market environment end of 2009
- Further decline in plasma volumes expected in 2010; market recovery from 2011
- Biotest recognised trend early and was able to adjust its plasma sourcing strategy accordingly Source: PPTA
USA: A highly attractive market for Biotest
- World s' largest market
- Highest per capita consumption in the world
- High price levels
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 10 BPC-owned plasma collection centres
BivigamTM (IVIG) development nears successful completion
immunoglobulin with a wide indication range (incl. antibody deficiency and autoimmune diseases)
- A polyspecific immunoglobulin comparable to Intratect Polyspecific ®
- Clinical development: successful conclusion of phase III
- Production of stability batches completed
- Submission of approval documents in Q3 2010, approval likely in Q3 2011
- Sales potential after approval: around \$100 million per annum
Pl P t i Plasma Proteins –Effi i t d ti t k Efficient production network
- 20 plasma collection centres
- L l f lf ffi i Level of self-sufficiency: 40% for standard plasma
- Exchange of intermediate products from US to Europe from end of 2010
- Network increases
CivacirTM: Attractive project is put on course
Hepatitis C immunoglobulin for reinfection prophylaxis p py after liver transplantation due to hepatitis C
- Hepatitis C: frequent cause of liver transplantations
- Prevalence: 5 to 10 times more frequent than hepatitis B
- CivacirTM: Project acquired as part of Nabi Biopharmaceuticals takeover
- Optimisation of manufacturing process, e g regarding consistency of neutralising e.g. regarding antibodies
- Clinical development expected to be continued in 2011
Biotest: A market leader in special preparations
Hyperimmunoglobulins and 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
IgM-enriched emergency treatment of serious bacterial infections (sepsis)
- Phase I clinical trial successfully completed
- Phase II clinical trial to start from end of 2010 immunoglobulin for ase c ca a o s a o e d o 0 0
- Indication spectrum comparable to that of Pentaglobin® g
- Very high functional activity
- Good tolerability
- Improved raw material utilisation
Cytotect®: Trial is progressing
Prevention of prenatal cytomegalovirus infection of unborn children whose mothers were infected for the first time during the pregnancy g pg y
- International phase III clinical trial to confirm positive findings of pilot study
- 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®: Europe-wide approval of first hepatitis B immunoglobulin with subcutaneous administration
Hepatitis B reinfection prophylaxis after a liver t l t titransplantation
- Europe-wide approval of new form of administration for hepatitis B immunoglobulin
- Administered subcutaneously ( d th ki ) (under the skin)
- Fast, pain-free, simple and safe
- Developed for self-treatment
Hepatect® CP and Zutectra® are an ideal combination
Reinfection prophylaxis after a liver trans transplantation due to hepatitis B infection
Hepatect® CP:
- Administered intravenously
- Optimal for intensive treatment g during and immediately after transplantation
Zutectra®:
- Optimal for self-treatment
- Suitable for long-term prophylaxis as administered subcutaneously
Biotest R&D activity in Plasma Proteins
Hepatitis B immunoglobulin in neonates
Phase III trial
- •Status: Recruitment ongoing (5 sites have recruited 30 patients)
- •End of Study planned for Q3 2010
- • Marketing Approval: aiming for marketing approval in Germany first, international marketing authorisations to follow
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
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
Biotest R&D activity in Plasma Proteins
- • R&D expenses in 2009 in the Plasma Protein segment: € 25 7 million; in 25.7 Q1 2010: € 8.4 million
- • 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
Investment in capacity at Biotest with a long-term horizon
- World demand continues to increase
- Biotest will continue to grow with the plasma segment
- Opening up the attractive US market by means of own production
- BivigamTM (IVIG) approval expected in Q3 2011
Additional market potential of \$100 million
Interim conclusion: Biotest is well positioned in plasma proteins
- US market entry with BivigamTM (IVIG) in 2011
- Product range expanded systematically
- Attractive p pi eline
- Increased efficiency due to production network
Biotherapeutics
Biotherapeutics: Attractive development projects
BT-061:Rheumatoidarthritis, plaque psoriasis
BT-062: Multiple myeloma
BT-063: Systemic lupus erythematosus
- Indications with a high medical need for effective and tolerable treatments
- Antibodies with specific mechanism of action
Bi th ti F d h otherapeutics: Focused researc
Biotherapeutics: Focused research
- •High medical need
- • Rapidl y growin g markets (in € million) p yg g
- •Blockbuster potential
Lead indications
| B T- 0 6 1 |
R h t i d A t h i t i e m a o r r s, u P i i s o r a s s |
|---|---|
| B T- 0 6 2 |
M l i l M l t u p e y e o m a |
| B T- 0 6 3 |
S i L t y s e m c u p u s E h t t r y e m a o s u s |
R&D expense – Biotherapeutics
Cap on Biotherapeutics R&D budget
Biotherapeutics: Continuously growing market potential
*CAGR: Compound Annual Growth Rate
Biotherapeutics: Significant project progress in financial year 2009
Phase I/IIa clinical trial approved by FDA (IND)
*
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 u e c s P i t t a e n s P l d a n n e |
S t t a u s |
|---|---|---|---|---|
| 9 6 1 |
H l t h l t e a y v o u n e e r s |
i l d s n g e o s e i d t 1 8 0 v ; a n s c u p o m g |
5 7 |
S d t u y l d t 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 v a n s c |
5 5 |
S d t u y l t d c o m p e e |
| 9 3 7 |
P h I I P i i a s e : s o r a s s |
l t i l d m u p e o s e, l b l l d t 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 ( Q t t d 1- a r e 2 0 1 0 ) |
| 9 6 2 |
P h I I R h t i d a s e a : e u m a o A h i i t t r r s |
M l t i l d u p e o s e, P l b l l d t a c e o c o n r o e |
9 6 |
R i t t e c r u m e n l d t c o m p e e |
| 9 7 1 |
P h I I R h i d A h i i t t t a s e e m a o r r s : u |
B T- 0 6 1 M T X + M M l l i i l l d d t t u u p p e e o o s s e e, P l b t l l d a c e o c o n r o e |
1 1 0 |
P I ( i ) t a r v f i l i d n a z e ( ) P t I I a r s c i o n g o n g |
| 9 9 7 |
P h I I b R h t i d a s e : e u m a o A A t t h h i i t t i i r r s |
0 6 1 B T- M T X + M l l t t i i l l d d u p e o s e, P l b t l l d a c e o c o n r o e |
2 0 0 ~ |
S b i i u m s s o n : Q Q 2 2- 2 2 0 0 1 1 0 0 |
BT-061: Results of clinical trials deliver proof of concept for rheumatoid arthritis
| P h I I t i l a s e a r a : |
|
|---|---|
| B T 0 6 1 - |
|
| l b v s p a c e o |
Phase II trial: BT-061 + MTX* vs. MTX* alone
Initial results*:
- Clear improvement in symptoms (ACR 20 70) –70)
- Generally good tolerability
Phase IIb trial (mid‐Q2 2010) ( )
- BT‐061+MTX** vs. MTX** alone
- About 200patients
- Basis for phase III trial (in 2012 at the earliest)
* Interim analyses / final results in Q3/Q4 2010 final
** MTX = methotrexate, a drug used in primary rheumatoid arthritis therapy
BT-061: Proven efficacy in treating psoriasis*
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):
- •~ 200 patients
- •Combination with MTX
- •12 weeks treatment
- •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
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
- Gradual further establishment of teams in Drug Development
BT-061 partnership
Biotest strategy:
Cooperation with partner f li i l h IIIfrom clinical phase
- Talks with international pharmaceutical companies
- High level of interest
- Desire for confirmation of positive trial results via further phase II clinical trials
- Stand-alone further development of mAb until agreement is reached
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
BT-062: Si l ng e-D St d 969 i Dose Study in M li l u p e M l ye oma 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 d l b l i i t e c a c a a a a a e y v |
1 7 |
% 1 0 0 |
||
| d i i s e a s e p r o 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 | 1 % 4 |
||
| b l d k i 6 t ≥ s a e s e a s e w e e s ‐ |
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
- •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 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)
Microbiological Monitoring
Segment continues to be successful
- Q1 2010 revenue growth of 10 1% achieved mainly by heipha 10.1%, heipha, but also Biotest HYCON products contributed to the growth
- Expansion of logistics capacities at heipha in Eppelheim
- Investment in research and development
- Strengthening of sales structures in the United States and Japan
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)
Therapeutic indications:
- • Replacement therapy in:
- 1.Primary Immunodeficiency Syndromes
- 2.My yp y eloma or chronic lymphocytic leukaemia
-
- Children with congenital AIDS and recurrent infections
- • Treatment of autoimmune diseases: ITP (idiopathic thrombocytopenic purpura) Guillain purpura), Guillain-Barré-Syndrome, and Kawasaki Syndrome
Properties:
- •St t t t Storage at room temperature
- •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 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® CP
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)
- • 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 antibodies HBs 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 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:
- • 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 l b li i dimmunoglobulin is preserved
- •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 duringp g y re nancy
- •Orphan Drug Designation (Europe, U.S., CH)
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.
First subcutaneous injectable HBIG for self administration
Therapeutic indication:
• 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-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
Cli i l ltClinical results:
• Protective anti-HBs-serum levels achieved in all patients in the registration trial with weekly Zutectra ® applications no HBV re- applications, infection occured
International Myeloma Working Group Response Criteria
| M j h i i f i i * t t t 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 |
I f 2 5 % f 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 h f l l i t m o r e o e o o n g w : S M ( b l i b t t t e r u m -c o m p o n e n a s o u e n c r e a s e m u s e / ) / 0. 5 1 0 0 l d ≥ 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 ) |
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| 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 |
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| M i ( M R ) i i i h t t t n o r r e s p o n s e n p a e n s w l d f t l r e a p s e r e r a c o r y m y e o m a |
% % f 2 5 b t 4 9 d t i M t i d d t i ≥ < 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 i l ( P R ) t a r a r e s p o n s e |
% f 5 0 d t i M P t i d d t i i 2 4- h ≥ 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 h h d d i i M M P P i i b b l l 0 % t t t t 5 ≥ e s e r m a n r n e r o e n a r e n m e a s r a e, a u u u u - f f d i t h d i b t i l d d i l d e c r e a s e n e e r e n c e e w e e n n v o v e a n u n n v o v e C f F L l l i i d i l t h M P t i i t i 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 - |
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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 v e a w c o s u e c s e x p e r e n c e ( ( ) ) f f D L T D D L i i i t i i T T i i i i t i i d i i d d t h h M M T T D D a o s e m n g o x c y s e n e a s e |
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Plasma Proteins: Production process
US source plasma collection forecast, 1996 -2013
Source: MRB "The Plasma Fractions market in the United States", 2007; PPTA; own estimates
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