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Biotest AG — AGM Information 2009
May 28, 2009
66_rns_2009-05-28_54ea545c-978d-418d-8c36-911f00445978.pdf
AGM Information
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Biotest: Creating Value. Living Values.
Biotest AG – 2009 Annual Shareholders' Meeting
Professor Dr. Gregor Schulz, Chairman of the Board of Management 7 May 2009
Biotest 2009 Annual Shareholders' Meeting
Creating Value. Living Values.
Biotest products are often vital
- •Important treatment for chronically ill patients
- •Life-saving in emergency medicine
- •Safety for transfusion and transplantation
- • Hygiene monitoring in pharmaceutical, food and cosmetics production
High ethical value creates economic value
Biotest strategy
Biotest – a global specialist for innovative immunology and haematology
- •Internationalisation
- •Focus on core competences
- •Research and development
Target Sustained profitable growth
2008 – highlights
- •US Plasma Proteins business: successful first year
- •Additional European product approvals
- •Capacity expanded
- • Biotherapeutics: promising data of clinical development
- •Partnering for BT-061 initiated
- • Medical Diagnostics: clear indications of an upward trend
Biotest: Creating Value. Living Values.
Plasma Proteins
Plasma Proteins: progressing into new dimensions
Plasma Proteins: revenue (in € million)
Plasma Proteins: 2008 highlights
- • Six further European approvals for immunoglobulins and albumin
- • Share of international sales up from 69% to 76%
- • Major tenders won for the delivery of coagulation factors
- •R&D projects advanced
- •Production capacity expanded
Plasma Proteins: ongoing and new product development
2008 approval:
Haemonine® Factor IX for the prophylactic and acute treatment of type B haemophilia – complements the range of coagulation factor products
European approval expected in 2009 (centralised procedure):
Zutectra® Hepatitis B immunoglobulin for prophylactic treatment of reinfection following liver transplantation, administered subcutaneously – self-medication possible
Approval after 2010:
| G ( S ) I V I U A : |
f P h I I I l d b d M t a s e c o m p e e y e n o a y , i i h d l d f d f 2 0 1 0 t t r e g s r a o n s c e e o r e n o u |
|---|---|
| I M t t g c o n c e n r a e : |
C l i i l d l d i Q 2 2 0 0 9 t t t t t n c a e v e o p m e n e x p e c e o s a r n |
Cytotect®: significant large-scale trial has started
Indication: prevention of prenatal cytomegalovirus infection of the foetus in women who were infected by the virus for the first time.
- • Phase III trial to confirm existing positive results from a pilot study
- •High ethical relevance
- • Comprehensive immunoscreening required (up to 20,000 tests)
- • Following initial difficulties, trial is fully underway: more than 2,000 pregnant women have been screened
Plasma Proteins production – capacity doubled
Biotest production network*
Fractionation:
- •Plant in Dreieich: 700,000 litres p.a.
- • Contract with C.A.F-D.C.F (Belgium): up to 300,000 litres p.a.
- • Boca Raton: 400,000 litres p.a. (from 2010)
Immunoglobulins:
- •Capacity in Dreieich doubled
- • Capacity expansion in Boca Raton (1.5 tonnes p.a. from 2010)
* In the final construction stages (2009/10)
Plasma collection – high level of own supply ensures independence and availability of raw material
- • 4 new plasmapheresis centres in 2008 21 centres in total worldwide(10 in Europe, 11 in the USA)
- • 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
BPC-run plasmapheresis centres in the USA
New centres opened in the USA in 2008/2009: Santa Fe (NM), Iowa City (IA)
Demand for Plasma Proteins is growing, but at a slower rate
Global IVIG market (in tonnes)
- New indications for immunoglobulins drive
- Upward price trend has
- Overall, no uniform trend identifiable
= Growth (over a 2-year period)
Total supply of donor plasma in the USA (in million litres)
Our assessment: industry responds to expected price reductions. Capacity adjustments in line with growth in demand (6% to 8% p.a.).
Outlook for Plasma Proteins: steady growth
- • Internationalisation of business through new developments and the expansion of existing approvals
- •Continued profitable growth is expected
- •Phase of strong price rises is coming to an end, but no price slump
- •Industry responds to reduction in surplus demand and adjusts capacity
Biotest: Creating Value. Living Values.
Biotherapeutics
Biotherapeutics: investment in projects with potential
Common features of Biotest'smonoclonal antibodies
- •High medical need
- •Rapidly growing markets
- •Blockbuster potential
Lead indications
| B T 0 6 1 - |
R h i d h i i t t t e m a o a r r s, u i i p s o r a s s |
|---|---|
| B T 0 6 2 - |
M l i l l t u p e m y e o m a |
| B T 0 6 3 - |
S i l t y s e m c u p u s h d t t e r y e m a o s u s a n h i t t o e r a o m m n e u u d i s e a s e s |
R&D expense - Biotherapeutics (in € million)
Rheumatoid arthritis and psoriasis – a huge and growing market
Market volume (in US\$ million)
Drug development: complex process with overlapping phases
- •R&D expenses for BT-061 alone approx. €25 million to date
- •Duration of the project >10 years
Development
- •Preclinical: from 2002: in vitro testing
- •from 2006: six toxicological in vivo trials
- • Clinical: to date, five trials with subjects and patients further Phase II/III trials in both indications
Production
- •From 2005: set-up of large-scale production (Lonza)
- •Since 2008: set-up of second production line at BPC
Marketing, patents
• To date, four groups of patents have been applied for worldwide, patents for the USA and other key countries have been granted
BT-061 – overview of clinical trials
Trial No. 961: (Phase I)
Single dose, intravenously and subcutaneously, healthy subjects (tolerability)
Rheumatoid arthritis
Trial 962 (Phase IIa):
Multi-dose, intravenously and subcutaneously, placebocontrolled
Trial 971 (Phase II):
BT-061 with MTX*, multi-dose, intravenously
Psoriasis
Trial 967 (Phase I/IIa):
Single dose, intravenously and subcutaneously, placebocontrolled
Trial 973 (Phase II): Multi-dose, intravenously and subcutaneously, placebocontrolled
*MTX = methotrexate
Biotest 2009 Annual Shareholders' Meeting
Very encouraging interim results from clinical trials
| * R h t i d t h i t i P h I I e u m a o a r r s a s e a − ( ) N 9 6 2 o |
/ * P i i P h I I I s o r a s s a s e a − ( ) N 9 6 7 o |
|---|---|
| M k d l i i l i i h t t a r e c n c a m p r o v e m e n w • h d d d t t t e o s a g e g r o p s s e o a e u u ( ) b i 6 2 5 % t t s u c u a n e o u s n u p o f i t t o p a e n s M i f f i b h i d b t a x m u m e c a c y o e a c e v e y • f f h i i i d t t r e r o p m s n g o o s a g e u |
I h i l l l d t t t n e r a p e u c a y r e e v a n o s a g e s • ( i ) k d l i i l t n r a e n o s m a r e c n c a v u i t i 7 5 % f t i t m p r o v e m e n n o p a e n s S P A I i d b 8 8 % t m p r o v e y u p o • f f L l i i h l t t t o n g a s n g e e c e e n o v w w • - d o s a g e s |
More than 190 patients involved in all trials, efficacy in both indications, general tolerability of BT-061 is good
* Dosage escalation trials: 75% of patients receive BT-061, 25% receive the placebo drug
Partnering for BT-061: process started successfully, positive response
Biotest strategy:
Co-development and co-marketing with "big pharma" from clinical Phase III onwards
- •Start of partnering process successful
- • Global pharmaceutical groups approached ("big pharma")
- •Predominately positive response
- • Negotiations started with selected companies
- • Agreement to be signed by the end of 2009/start of 2010
BT-062 – good tolerability, clear indications of efficacy
- •BT-062: specific and highly effective immunotoxin
- •Clinical trials in cancer centres in the USA
- •General tolerability of the agent is good
- • Indications of efficacy already with low dosages:
- • Aggressive progress of the disease halted in some patients
- • Effect has already lasted for several months in individual patients
Summary – Biotherapeutics reach new development stage
- •Significant progress with all projects
- •BT-061: partnering process started
- •Start of Phase I for BT-063 in first half of 2009
- • Set-up of own production of monoclonal antibodies progressing well at BPC
- • Projects require considerable effort and are associated with risks up to the final stage. However, they offer major opportunities for steady revenue in the long term.
Biotest: Creating Value. Living Values.
Microbiological Monitoring and Medical Diagnostics
Microbiological Monitoring continues to perform well
- • Sales increase in 2008: €38.3 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: 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
- • Slight upward trend – however, sales and profit development remain unsatisfactory
- • Cooperation with a strategic partner planned, search for partner has high priority
Biotest: Creating Value. Living Values.
Financials 2008
Sales and EBIT rise to new record levels in 2008
358.964.10501001502002503003504004502007 2008Biotest Group BPC 326.4423.0+10%+30%
Sales (in € million)
Marked increase in profit, reduced tax ratio
EBT and EAT (in € million)
- • Sharp rise in earnings before tax (EBT), despite higher expenses as a result of financing the US transaction
- • Increase in earnings after tax (EAT), mainly as a result of the reduced tax ratio
- •Tax ratio: 30.6% (2007: 42.7%)
Strong financial structure provides stability
Balance sheet of the Biotest Group (in € million)
Assets
- •Higher inventories driven by growth
- • Trade receivables reduced by 6.5% through factoring
Liabilities
- • Shareholders' equity up as a result of earnings after tax
- • Sales-driven increase in trade payables
- • Equity ratio for 2008: 42.8% (2007: 42.1%)
Long term debt financing secured
Residual term of financial liabilities
(31 December 2008, in € million)
65.5101.128.2020406080100120<1 year 1-5 years >5 years
- • Financial liabilities as of 31 December 2008: €194.8 million (2007: €188.8 million)
- • 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 share – sharp rise in share price up to summer 2008, subsequent development disappointing
- • Both share classes recorded an all-time high in August 2008:
- •€67.00 (ordinary shares), €64.00 (preference shares)
- •Subsequent sharp decrease in share price has continued in 2009
Comparison of Biotest shares (as of year-end 2007 = 100)
2009 outlook – strong first quarter, further growth expected
- • Preliminary figures for Q1 2009:
- • Sales +13% compared with Q1/2008, growth in all segments
- •EBIT +8%
- • Economic crisis has had no significant impact to date – however, increased vigilance is necessary
- • Targets for 2009:
- •Sales +10%
- •EBIT at previous year's level (€55 million)
Creating Value. Living Values.
Biotest – sustained company value
- •Successful operations
- •Growth opportunities
- •Pipeline with strong potential
- •Sound financing
- •Highly qualified and committed employees
Agenda item 2 – appropriation of profits
| C i d a r r e f € 8 9 0 3 8 8 3 d 7 5 o r w a r : , , |
• |
|---|---|
| D i i d d e n v - P f h € 1 9 7 8 5 7 2 6 0 r e e r e n c e s a r e s : , , |
|
| D i i d d e n v - O d i h € 1 8 4 7 9 9 9 8 8 r n a r s a r e s y : , , |
|
| D i i b b l f i *: € 1 1 7 1 6 9 6 0 8 3 t t t s r a e p r o u , , |
- Dividend unchanged to last year:
- •€0.30 per ordinary share
- •€0.36 per preference share
- •Pay-out ratio: 32.7%
- Shareholders participate in growth
- Company's financial strength is enhanced
*Biotest AG financial statements prepared in accordance with the German Commercial Code (HGB)
Agenda item 8 – authorised capital
- • Authorised capital: share capital increase (on one or more occasions) by up to €1,075,200.00
- • Preference shares issued to employees:
- •Tool for increasing employee loyalty
- •Incentive to promote entrepreneurial thinking and actions
- •Reflects value-oriented approach
- •Up to 100 shares per year
- •20% reduction on average share price of the preceding 60 trading days
- •Members of the Board of Management and managing directors are excluded
- •Maximum dilution of 3.5%
Biotest: Creating Value. Living Values.
Thank you for your attention.