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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:

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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

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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

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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

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  • 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.