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Biotest AG — Investor Presentation 2009
Nov 11, 2009
66_rns_2009-11-11_4df7c8d3-e12d-4961-bf23-ddb2d5854cf3.pdf
Investor Presentation
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Biotest Group: Creating Value. Living Values.
Management Presentation
Biotest AGNovember 2009
Biotest Management Presentation − November 2009
Biotest at a glance
| F i 1 Q Q 1 Q Q 3 3 2 0 0 9 g r e s u - |
: | |
|---|---|---|
| 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 |
€ 3 6 1 9 m € 2 9 4. 3 m € 4 5 2 m |
( 1 2. 0 % ) + ( 1 2. 8 % ) + ( 3. 0 % ) + |
Business sectors
Biotest −key figures
- • Headquarters in Dreieich/Germany (Frankfurt area)
- • Subsidiaries in 10 countries worldwide
- • Employees (FTE)*: 2,135 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 5,133,333
Headquarters, Dreieich eadqua e s, e e c
*: as of 30 Sept. 2009
Biotest strategy
- •Internationalisation
- •Focus on markets with special needs
- •Research and development
Target Sustained profitable growth
Biotest Group overview
European production and distribution sites
Additional sites overseas:
- •USA: Florida ( ), New Jersey ( )
- • Japan: Tokyo ( )
- •Distribution also via 138 distributors in
Sales by region (Q1-Q3 2009):
About Biotest – strong track record
- • Strong revenue growth, particularly in Plasma Proteins business
- • Plasma Proteins account for 80% of Group's sales in 2008
- • EBIT increase by 199% from 2004 to 2008
Biotest shares: positive development in 2009
- • Decline of share price after majority shareholder terminates discussions about shares´s sale
- •Share price increase triggered by positive news flow positive
Biotest shares and SDAX in 2009 (index)
Shareholder structure
| B i t t o e s |
G A |
|---|---|
Ordinary shares: 6.6 mio with voting rights
OGEL GmbH*: 50.03%KSK Biberach*: ~24%Mass. Mutual Life I C* nsurance Comp.*: ~3% Free Float: ~23%
56.4% of total capital, and 100% of voting rights 0% of voting rights
Preference shares: 5.1 miono voting rights, but higher dividend
Free Float: 100%
43.6% of total capital, 0% f i i h
* as of November 2009
Biotest: History and milestones achived
Biotest Group: Creating Value. Living Values.
Financials and highlights of Q1-Q3 2009
Q1-Q3 2009 / Highlights Q3
- • Bi t t G S l b 12 0% d otest Group ales up by 12.0% an EBIT increased by 3.0%
- • Confirmation of 2009 Guidance: S l 10% d EBIT t ales +10% anEBIT at € 55m
- • Medical Diagnostics: Signing of purchase agreement with Bio-Rad Laboratories, Inc.
- • Zutectra received positive CHMP* opinion for marketing approval in EU
- • Biotherapeutics: further data demonstrating efficacy of BT-061
- • Clinical Phase III of IVIG () y US successfull completed
- • Commissioning of technical plant ongoing in Boca Raton
*: Committee for Medicinal Products for Human Use (CHMP); The positive opinion is based on data available to the EMEA, as part of the centralised approval procedure.
Biotest to sell Medical Diagnostic business to Bio-Rad
- • Contract signed to sell a major part of the Medical Diagnostics segment to Bio-Rad Laboratories Inc. (Hercules, CA/ US)
- • Transaction subject to closing conditions, incl. merger approval and is expected to close in first quarter 2010
- • Bio-Rad will acquire all shares of Biotest Medical Diagnostics GmbH (Dreieich) Rad and Biotest Diagnostics Corporation (Rockaway/ US), as well as the transfusion and transplantation diagnostics business in Biotest Group´s international subsidiaries under an asset deal; H1 revenues of activities to be sold approx. € 21 million
- •Purchase price: € 45 million
- • Transfer of assets and certain liabilities, except shareholder loans granted to BMD and BDC of approx. € 16 million
Sales continue to increase, EBIT increase at lower rate
EBIT (in € million)
Plasma Proteins business drives EBIT
EBIT by segments (in € million)
| Q Q 1 3 - 2 0 0 9 |
Q Q 1 3 - 2 0 0 8 |
|
|---|---|---|
| P l P i t a s m a r o e n s |
6 3 7 |
6 0 1 |
| B i t h t i o e r a p e c s u |
1 3 2 - |
1 0 1 - |
| M i b i l i l M i t i c r o o o g c a o n o r n g |
3 7 |
3 9 |
| M d i l D i i t e c a a g n o s c s |
1 4 - |
2 5 - |
| C / R i l i i t t o r p o r a e e c o n c a o n |
6 7 - |
7 5 - |
- • EBIT of Plasma Proteins segment increased by 6.0 %
- • Biotherapeutics EBIT influenced by level of maturity of clinical studies
- • EBIT improvement of Medical Diagnostics due to increased sales in the US
Increase in profit in Q1-Q3 2009
EBT d EAT (i € illi ) EBT an (in million)
- • Rise in earnings before tax (EBT), due to more favourable financial result as a result of lower interest expenses
- • Earnings after tax after (EAT) at € 25.1 million
- • Tax ratio: 30.3% (Q1-Q3 2008 : 30 8%) 30.8%) 25.1
Strong balance sheet
Balance sheet of the Biotest Group ( € ) (in million)
Assets
- • Higher inventories driven by growth and products which could not be marketed as planed
- • Higher Trade receivables due to hi h l l i l ihigher sales volumes mainly in the plasma proteins segment
Li bilitiLiabilities
- • Increase in current financial liabilities, primarily corresponding to working capital development
- •Equity ratio as of 30 Sept. 2009:
Cash Flow from Operating Activities in € million
Q1 – Q3 : January – September 2009
Long term debt financing secured
Residual term of financial liabilities
(31 December 2008, in € million)
€188 8 million) 120 101.110065.5608028.240020<1 year 1 5 years >5 years 1-5
- • Financial liabilities as of 31 December 2008: €194.8 million (2007: €188.8
- • Extension of existing credit line (€40 million) in November 2008
- • Total credit line expanded by €40 million in May 2009 (maturity of 2 years)
- • Sufficient flexibility to support further growth
Biotest Group: Creating Value. Living Values.
Plasma Proteins
Plasma Proteins business at a glance
Biotest Plasma Protein products Protein
- •Global market share: 3%
- • Market share in relevant markets (GER, AUT, CH, GRE, UK): 14%
- • Intratect ® market share in GER, AUT, CH: > 13%, in UK: > 9%
- • World market leader with Cytotect ®and Varitect®
- • Leading position with Hepatect ® in Europe and Nabi HBTM in USA
- • Biotest covers full value creation chain: plasma sourcing, production, distribution vertical integration leads to g rationalisation and higher productivity
Plasma Proteins: Production process
Plasma Proteins production – capacity doubled
Biotest production network* Fractionation: p
- •Plant in Dreieich: 700,000 litres p.a.
- C t t ith C A F D C F (B l i ) •Contract withC.A.F-D.C.F elgium): up to 300,000 litres p.a.
- •Facility included in regulatory files
- •10 year contract
- •Boca Raton: 400,000 litres p.a.
Immunoglobulins:
- • Capacity in Dreieich doubled
- • Capacity expansion in Boca Raton (1 5 tonnes p a from H1/2011) (1.5 p.a.
* In the final construction stages (2010/11)
Status Projekt IVIG and Boca Raton (USA)
•IVIG clinical Phase III
- Clinical phase III study completed
- Finalization of clinical study report in Dec. 2009
• Enlargp y ement of production facilit
- Construction work part 1 nearly finalised; commissioning of facility has started
- Completion of production facility (part 1) in Q4 2009
- Final completion of utility systems and warehouse (part 2) in H1 2010 in
- Final capacity: 400.000 l fractionation 1.5 t immunoglobulin purification
•Registration of IVIG
- Submission of BLA to FDA in mid 2010
- Expected approval in H1 2011
Plasma collection – high level of own supply ensures independence and availability of raw material
- •4 new plasmapheresis centres in 2008 BPC-run plasmapheresis centres in the USA
- • 21 centres in total worldwide(10 in Europe, 11 in the USA)
- • L l f l tt i t Level of own supply set to rise to over 45% by the end of 2009:
- •Less dependent on price fluctuations
- •Supply of hyperimmune plasma
- •Production network Europe - USA States with centres at time
New centres opened in the USA in 2008/2009: Santa Fe (NM) Iowa City (IA) (NM),
Plasma Proteins: further growth in sales, but at a slower rate
Plasma Proteins: sales volume (in € million)
- • Sales in Plasma Proteins jumped by 37% in 2008 (incl. BPC for the first time)
- • Contribution BPC in 2008: €64.1m
- • In Q1-Q3 2009 Plasma Protein sales increased by 12.8% to € 294.3 million
New indications and higher
Demand for Plasma Proteins is growing, but at a slower rate
•
Global IVIG market (in tonnes)
Immunoglobulins: approval of U.S.-IVIG bears significant upward potential
- • Total volume IVIG world market as of 2008: ~90 tons
- • USA by far the most important market for IVIG worldwide
- • Registration of BPC's U.S.-IVIG (comparable to Intratect ®) expected for H1 2011
Sources: MRB, APFA, UBS, Biotest Market Research
US source plasma collection forecast, 1996 - 2013
Source: MRB "The Plasma Fractions market in the United States", 2007; PPTA; own estimates
Plasma sourcing trends in the US
Plasma Centers in US
| 2 | 2 | 2 | |
|---|---|---|---|
| 0 | 0 | 0 | |
| 0 | 0 | 0 | |
| 5 | 7 | 9 | |
| A i l p r |
2 9 0 |
3 3 0 |
4 0 1 * |
| M | 2 | 3 | 4 |
| a | 9 | 3 | 0 |
| y | 1 | 2 | 0 |
| J u n e |
2 9 0 |
3 3 4 |
3 9 1 |
Collected Plasma in US (litres mio.) US(litres
| 2 0 0 5 |
2 0 0 7 |
2 0 0 9 |
|
|---|---|---|---|
| A i l p r |
0 6 8 |
0 9 9 |
* 1. 5 8 |
| M a y |
0 6 7 |
1. 0 2 |
1. 3 5 |
| J u n e |
0 6 7 |
1. 0 2 |
1. 5 4 |
Reaction of plasma industry:
- • Closing of first plasma collection centers in the US
- • Reduction of opening hours in tcenters
- • Lower compensation paid to donors
- • Reduction of plasma collection volumes
*: Highest number since 2003 Source: PPTA
Plasma market analysis
- • We expect, that plasma sourcing activities will be reduced over time
- •This will lead to reduction of inventories
- • It is our assumption, that the plasma market environment will stabilise within the next 1-2 years, and therewith also the pricing sit ti uaon
Plasma Proteins: Q1- Q3 2009 highlights
- • Market entry in additional European countries after regulatory approval: Human Albumin Hepatect ® Haemoctin ®, , , Haemonine®
- •Share of international sales up to 77%
- • Tenders won for the delivery of coagulation factors
- •R&D projects advanced
- •Production capacity expanded
Plasma Proteins: ongoing and new product development
European approval expected in 2009 (centralised procedure):
Zutectra Hepatitis B immunoglobulin for prophylactic treatment of reinfection following liver transplantation transplantation, administered subcutaneously – self-medication possible
Approval after 2010:
| I V I G ( U S A ) : |
P h I I I l d b d f M 2 2 0 0 0 0 9 9 t a s e c o m p e e y e n o a y , F i l l i i l b l d l i h t t t t t n a e v a u a o n a v a a e : g o o r e s u s w r e s p e c o f d f f i t s a e y a n e c a c y R l l h d l d f H 1 2 0 1 1 t e g u a o r y a p p r o v a s c e u e o r |
|---|---|
| I M t t g c o n c e n r a e : |
C Q l i i l d l t P h I t t d i 2 2 0 0 9 n c a e e o p m e n a s e a s s a r e n v w f R i t t d t t t h l t h l t l t d e c r u m e n a n r e a m e n o e a y v o u n e e r s c o m p e e G d t l b i l i t b d o o o e r a y o s e r v e |
Biotest received positive opinion for Zutectra ®
| H H i i B t t u m a n e p a s |
T h e r a |
|---|---|
| i l b l i ( H B I G ) m m u n o g o u n |
• |
| f t d f l f m a n u a c u r e r o m p a s m a o |
|
| d i t h h i h t i- H B o n o r s g a n s w |
|
| t i b d t i t a n o y y r e s |
P r o |
First subcutaneous injectable • High specific activity of 500 IU/ml HBIG f lf d i i t ti bfor self-aministration by the patient
peutic indication: p
• Prophylaxis of HBV re-infection after liver transplantation
perties:
- • Subcutaneous injectable HBIG in a pre-filled syringe = ready-for-use
Clinical Results:
• Effective anti-HBs-serum levels achieved in all patients in the registration trial with weekly ®Zutectraapplication, 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
- • Zutectra® will strengthen and defend current strong market position by preventing possible switch to i.m. and future i.v. drugs
- • Further Launches for Zutectra® and Nabi HBTM HB already scheduled in attractive world in wide markets
Two ideal therapies designed for acute and maintenance treatment
….. with proven efficacy and safety
| ® C H t t P e p a e c |
® Z t t u e c r a |
|---|---|
| i l l b h l d d d f h i h d t t w e e g o s a n a r o r g o s e … i l i i d d i h t t t n r a v e n o u s a p p c a o n n e e e n e i- i h f l i t t t t t p e r o p e r a v e p a s e a e r r a n s p a n a o n |
i l l d i d w a s e s p e c a y e s g n e … i l i f d f f i t t t t t t t t o s m p y c u r r e n r e a m e n a n o o e r p a e n s f l i b i l i i h i d l i f t t m o r e e x y n e r e v e r y a y e |
| f d d i t i l i d i t i t a o n a n c a o n s e g o r p o s … h l i d H B V e x p o s u r e p r o p y a x s a n h l i i b p r o p y a x s n n e w o r n s |
f l d i i t t i • e a s s e a m n s r a o n y i d i f h i i d t t • m e a n c o s s a v n g o r p y s c a n s a n i t t p a e n s l l l d d i l i j i ( l 1 l ) t t t • w e o e r a e a n p a n e s s n e c o n o n y m f • s g a r- r e e u |
IgM Concentrate
IgM Concentrate is successor product of Pentaglobin®
Lead indication:Sepsis
Current Status:Phase I Study
- •24 healthy volunteers (18 - 45 years)
- •Single dose: n = 18 (incl. Placebo); multiple dose: n = 6
- •Recruitment and treatment of healthy volunteers completed
- •No major safety issues, no occurrence of SAEs*
Phase II preparation activities ongoing:
- • Development of synopsis and study protocol (indication, endpoints, sample size)
- •Preparation of PEI and FDA-Advice in Q1 2010
*: SAE = Serious adverse event
Summary Plasma Proteins: Biotest made significant progress in implementation of its corporate strategy
- •Biotest will grow the Plasma Proteins segment
- • P i th U S k t t d d Presence in the U.S. maret extene
- • Regulatory approval for IVIG expected H1 2011 Market potential for this product in USA estimated to be > \$ 100 m
- •Strong R&D pipeline: New products and new clinical indications
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
| 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 d t t r y e m a o s u s a n 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)
- After approval: significant market share is realistic
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 i t n c a o n |
D i e s g n |
S b j t u e c s l d p a n n e |
S t t a u s |
|---|---|---|---|---|
| 9 6 1 |
H l t h l t e a o n e e r s y v u |
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 3 |
S d t 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 p p a c e o c o n r o e i d t 2 5 a n s c p o m g v u |
6 5 3 |
R i t t e c r m e n u l d t 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 u p e o s e, l l b b t t l l l l d d p p a a c c e e o o- c c o o n n r r o o e e |
4 8 |
S b i t t d m e u S b 0 9 t e p e m e r |
| 9 6 2 |
P h I I R h t i d A t h i t i a s e a : e u m a o r r s |
l t i l d m u p e o s e, l b t l l d p a c e o c o n r o e |
9 6 |
R i t t e c r u m e n i o n g o n g |
| 9 7 1 |
P h I I R h t i d A t h i t i a s e e m a o r r s : u |
B T- 0 6 1 M T X + l i l d t m u p e o s e, l b t l l d p a c e o c o n r o e |
1 1 0 |
R i t t e c r m e n u i o n g o n g |
Study 967 single dose Psoriasis:
Blinded PASI course for all dosing groups* including p p lacebo patients
0.5 mg and 2.5 mg single iv dose with a pronounced and long lasting PASI response up to 75 days after single dose application
PASI = Psoriasis Area and Severity Index) *evaluation of 25 mg sc dose level ongoing
Monotherapy Rheumatoid Arthritis:
Status of Study 962
- • B d d fi di i d Broa dose nding iv an d sc
- •Most effective dose iv: 2 mg
- •Sc: comparable efficacy at 50 mg
- •Higher sc doses currently under evaluation in ongoing study sc ongoing study
Study 971 MTX-Combination Rheumatoid Arthritis:
ACR response after multiple applications (Part I)*
| W k l l i i t e e y a p p c a o n f 8 k o r w e e s A C R k 9 t a w e e |
0. B T- 0 6 1 i 5 m g v M T X + ( 8 ) n = |
2 B T 0 6 1 i m g v - M T X + ( 2 4 ) n = |
P l b i M T X + a c e o v ( 8 8 ) ) n = |
|---|---|---|---|
| A C R 2 0 |
/ 8 5 ( 6 2 % ) 5 |
1 8 / 2 4 ( % ) 7 5 |
4 / 8 ( 0 % ) 5 |
| C A R 5 0 |
/ 1 8 ( % ) 1 2 5 |
/ 1 0 2 4 ( % ) 4 1 7 |
/ 2 8 ( % ) 2 5 |
| C 0 A R 7 |
1 / 8 ( ( 1 1 2 2 % % ) ) 5 5 |
4 / 2 4 ( ( 1 1 6 6 % % ) ) 7 7 |
0 / 8 ( 0 % ) |
*Data cut off: September 2009, Unblinded Data from Interim Analysis (n=40)
Study 971 MTX-Combination Rheumatoid Arthritis:
Kinetic of ACR70 response (%) of BT-061 Compared to other biothera peutic1 (TNFα anta gonist, no direct com parison 2 p p ( g p )
BT-061: summary clinical results
Psoriasis :
• Pronounced and long-lasting reduction of PASI scores observed in single dose psoriasis study at very low doses (0 5 mg iv 2 5 mg iv) study low (0.5 iv, 2.5
Rheumatoid Arthritis:
- •Competitive ACR20, 50, 70 responses at 2 mg iv and 50 mg sc
- • Higher response rates anticipated by further dose optimization and by prolongation of treatment period
- • Still sharp increase of ACR responses at week 9: further improvement expected ih i d d wit h continued treatment
- •Typical plateaus of ACR response observed for biologics not reached yet*
*expected plateaus: ACR20 after 3 months; ACR50 after 4 months; ACR70 after 6 months PASI = Psoriasis Area and Severity Index)
BT-061: clinical development Next steps
Rheumatoid Arthritis:
- • Ongoing Phase II combination trial (+ MTX):
- treatment of additional p g atients with 50 m g sc in combination with MTX
- • New Phase II clinical trial planned:
- inclusion of more patients (200-300) in relevant dose levels
- extension of treatment period up to 3 month
broadening efficacy and safety data base
Psoriasis:
- • Phase II clinical trial (48 patients) submitted:
- first patient expected to be included in December 2009
- finalization of dose-finding (focus on sc administration)
- repeated weekly dosing and extension of treatment period up to 8 weeks
higher response rates expected
Partnering for BT-061: process started successfully, positive response
Biotest strategy:
Co-development and co-marketing with "big bigpharma" from clinical Phase III onwards
- •Start of partnering process successful
- • Global pharmaceutical groups approached ("big pharma")
- •Predominantly positive response
- •Close interactions with selected companies
- • F th d t ill b b itt d (Q4/2009) Further ata willbe sumitte
- •Request of non-binding offer
- •Agreement expected in H1/2010
BT-062 : good tolerability, first indications of efficacy
1American Society of Haematology, Dec. 2009
- • BT-062: specific and highly effective immunotoxin: t i t di t hi h ffi toxin part medi ates g h efficacy antib d t di t tib ody part medi ates high specificity
- • Phase Study ose esca at o study pat e ts t I Study: Dose escalation study in patie nts with relapsed or relapsed/refractory Multiple Myeloma
- • Clinical trials in 4 cancer centres in the US, open label, repeatd i l d te d single dose
- • Indications of efficacy already with low dosages:
- Di i h l d i i f Disease progression alte in some patients for several months
- Seventh dose level completed (maximal tolerated dose identified)
- publication of first data on scientific congress1
Based on positive results from Phase I trial, a US- based multidose trial (Phase I/IIa) has been submitted in October 2009
Multiple Myeloma − unmet need and high market potential
Survival rates for MM patients in the USA
(Source: SEER Cancer Statistics Review,1975 - 2004) (Source: Company data and Biotest analysis 2009)
Sales of novel targeted MM therapies (in US\$ million)
BT-063: competitive advantages due to unique mode-of-action
BT-063 lead indication
- •Systemic Lupus Erythematosus (SLE)
- • Hi g y, h medical need: SLE incurable today, no new approval since ~ 40 years
- • 2.5 million patients are suffering from SLE worldwide today
Mode-of-action
- • BT-063 positively modulates the immune 063 system in this indication
- • Few other biologics in development: mostly anti B cell antibodies
Clinical development
• Phase I trial has started in healthy volunteers healthy in October 2009
BT-063: expected SLE market development
- •Market without specific or curative agents –
- •Novel immunomodulatory agents will develop the SLE market
Market share of SLE therapies (in %) Market%)
Outlook Biotherapeutics: reach new development stage
Significant progress with all projects
BT-061:
- •clear proof-of-concept in RA and Psoriasis
- •last patient of Phase I / IIa clinical trial in Psoriasis recruited
- •additional Phase II trial in Psoriasis will start in Dec. 2009
- • new Phase II trial in RA with 200-300 pts will be submitted in H1/2010
- •partnering process ongoing
BT-062:
- •first indications of efficacy from dose dose-escalating study escalating
- •multidose trial submitted in October 2009
BT-063:
- •Phase I trial started in September 2009 trial
- •first healthy volunteers treated
Production:
S tf f ti f l l tib di •et-up o f own manufacturing o f monoclonal antibodies progressing well at BPC
Biotest Group: Creating Value. Living Values.
Microbiological Monitoring and Medical Diagnostics
Microbiological Monitoring: Biotest leading supplier
Reagents and system solutions for:
- •Hygiene Monitoring
- •Detection of germs and particles
Main Products:
- •Microbiological air samples (RCS)
- •Air Particle Counters (APC)
- •S f i di t (OKI) Surface germ indicators
- •heipha culture media
Market Position:
- •Among top 5 worldwide
- •Market share 8-10%
Microbiological Monitoring continues to perform well
- • Sales increase in Q1-Q3 2009: €31.3 million (+9.1%);
- • Complex and high quality standards require high quality products
- •Pooling R&D activities at the Eppelheim site
- • R&D: focus on solutions for the paperless laboratory
Medical Diagnostics: reagents and system solutions
Transfusion
Id ifi i f bl d Identification of blood groups Search for antibodies
Main products:
- • TANGO®optimo
- •Erytype
- •Solidscreen
- • Manual Test Reagents
Competitive position:
- •No. 4 worldwide
- • Market share: 4% (Europe: 6-7%)
- •Competitors:
- Biorad
- Immucor
- Ortho
- Diagast
Transplantation
T i f tiTyping of tissues - Tepnel
- •HLA Serology
- • HLA DNA Tests(ELPHA, SSP)
-
• HLA Antibody diagnostic
-
•No. 4 worldwide
- • Market share: 8%
- • Competitors:
- One Lambda
- Invitrogen
- T l
Medical Diagnostics: improved business trend, but situation remains difficult
- • Difficult market conditions in Europe, USA remains an attractive market
- • Approval of manual reagents facilitates presence as full-service provider in the USA
- • Sales increase in Q1-Q3 2009 to € 36.3 million (+9 0%) (+9.0%) – however sales and profit however, profit development remain unsatisfactory
- • Purchase Agreement signed with Bio-Rad; Closing of the transaction is expected in Q1/2010
Outlook 2009
Our goals for the year 2009:
- •Increase in sales of about 10 %, EBIT on last year´s level at 55 € m
- • EBIT 2009 on level of 2008 due increased pricing pressure in plasma protein segment, potential exchange rate impact and unabsorbed facility costs resulting from expansion of production capacity
- • Economic crisis has had no significant impact to date – however, increased vig y ilance is necessary
Creating Value. Living Values.
Biotest – sustained company value
- •Successful operations
- •Growth opportunities
- •Pipeline with strong potential
- • S d fi i Sounfinancing
- • Highly qualified and committed employees
Disclaimer
This document contains forward-looking statements on overall economic developments 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 statements and assumes no obligation to do so.
All comparative figures relate to the corresponding last year's period, unless stated otherwise.
Analysts Conference
Contact and Financial Calendar 2010
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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-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 infectionsinfections
- •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
Therapeutic 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 transplantation (gold standard)
- • P t h l i ft 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-f i t il free, isotonic low-salt l ti lt 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 free, low-salt solution salt
- • Orphan Drug Designation for prevention and treatment of congenital CMV-infections (p ) Europe, U.S., CH)
Clinical trial:
- • Phase III study to prevent CMV infection in children of mothers who acq py uired a primary CMV infection during pregnancy
- • Ongoing process to optimise recruitment and study procedures
Haemoctin® / Haemonine®
Chromatographically purified, double virus inactivated coagulation factors concentrated from plasma 2.
Therapeutic indications:
- • Prevention and treatment of bleeding in:
- 1.Haemophilia A (Haemoctin®)
- 2 Haemophilia B (Haemonine®) Haemophilia (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 i hibit t t t ith hi h d f 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. Properties:
Therapeutic indications (after approval):
• Prophylaxis of HBV re-infection after liver transplantation
- • Subcutaneous administration – ready for self-administration by patients
- •Ready-for-use solution in pre filled syringe
- •High specific activity of 500 IU/ml
Safe and convenient HBV re and re-infection infection prophylaxis for liver transplant patients
Clinical trial:
- • Ph III t d l t d d b itt d f Phase III study completed and submitted for a centralised European authorisation procedure
- • Approval expected end of 2009