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Biotest AG Investor Presentation 2008

Sep 30, 2008

66_rns_2008-09-30_9fe6dff4-e398-4bf8-9185-2307e3c288e7.pdf

Investor Presentation

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Management Presentation

Biotest AG

Stockholm

September 2008

Company Presentation www.biotest.de 0

Biotest: Overview

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Biotest Pharma: Plasma Proteins

  • •Global market share: 3 %
  • •Market share in relevant markets: 10 %
  • • Major competitors: Baxter, CSL Behring, Talecris, Octapharma, Grifols
  • • Intratect® market share in Germany, Austria and Switzerland > 25 %; UK > 15%
  • • World market leader with Cytotect ®and Varitect®
  • • Leading position with Hepatect ® in Europe and Nabi HB in USA
  • •Albumin: commodity

Passive Immunisation during Pregnancy for Congenital Cytomegalovirus Infection

(Nigro G. et al, N Engl J Med 2005; 353: 1350-62)

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The transmission rate of 40 in the control group

Corresponds with published data.

With Cytotect the rate was lowered to 16%.

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15 fetuses of the Cytotect group showed symptoms in ultrasound. With Cytotect therapy the symptoms disappeared in all but one cases.

Effect of cytomegalovirus prophylaxis with immunoglobulin or with antiviral drugs on posttransplant non-Hodgkin lymphoma.

Opelz et al., Lancet Oncology 2007; 8: 212-218

  • • After prophylaxis with CMV immunoglobulins no non-Hodgkin lymphomas occur (40% Cytotect ®) in the first year following transplantation.
  • • The protective effect of immunoglobulins is not measurable in later periods. Most lymphomas develop within the first year after transplantation.

Immunoglobulins: Increasing demand worldwide

IVIG [tons]

Source: Review of Australia's PFA 2007

Biotest Pharmaceuticals Corporation (BPC): Our US market entry

  • • Acquisition of Plasmaprotein business of Nabi Biopharmaceuticals Inc.:
  • •Asset-Deal (\$185 m USD)
  • •Closing: December 2007
  • • Transfer of Assets into Biotest Pharmaceuticals Corp.

BPC – Investment rationales:

Immediate strong presence in the US market

Global leader in hepatitis B hyperimmunoglobulin market

Additional capacity (plasmapheresis, production)

Experienced and driven team of experts

Positive contribution to sales + EBIT from the very start

Promising R&D pipeline with huge market potential

Company Presentation www.biotest.de 6

Important Assets of Biotest Pharmaceuticals Inc. (BPC, Florida)

Plasma protein production plant

  • •Built in 2002, certified by FDA
  • • Fractionation capacity 400,000 litres (after limited capex)
  • •Maximum output 1.5 tons IVIG
  • •Includes labs, QC, storage capacity

Plasma collection centers

  • •Nine centers in seven US states
  • •Certified by FDA and EMEA
  • • Collection volume ∼400,000 litres
  • • 1 new center opened in July 08, 3 more to come in 2008/09

Biotest Pharma - Plasma Proteins: Strategy

  • •Building US presence with Biotest Pharmaceuticals Corp. (BPC)
  • • FDA approval for polyspecific IVIG in the US in 2010 - FDA approval for Civacir in the US in 2013
  • •Plasma sourced from own pherese centers > 50%
  • • Increase of fractionating capacity (with partners and BPC) to 1.4m litres
  • • Increase of production capacity for immunoglobulins (Dreieich and BPC) > 5,5 tons
  • •European-wide approvals of all Biotest plasma proteins

Biotest Pharma: Biotherapeutics

Biotest Biotherapeutics: Focused Research

Three monoclonal antibody (MAB) projects:

  • High medical need
  • Fast growing markets
  • Blockbuster potential

Biotest MABs and major indications:

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Expenditures for Biotherapeutics [m €]

Monoclonal antibodies:Investments offering considerable potential

BT-061: Rheumatoid arthritis (RA), psoriasis

  • • High medical need: approx. a quarter of patients do not respond, or not sufficiently, to approved therapies
  • •Approx. 6 million patients suffer from rheumatoid arthritis
  • • Volume of biotechnological RA drugs in 2007: US\$8.8 billion, forecast for 2010: US\$12 billion

BT-062: Multiple myeloma (MM)

  • • High medical need: there is no known cure for multiple myeloma to date; survival rate is 10 years from diagnosis in around 5% of cases
  • • Volume of MM therapeutics in 2007: US\$2.5 billion, with strong market growth

Unique mode of action of BT-061: Effect on key regulatory function of the human immune system

Complex and versatile process of inflammatory cascade

Unique mode of action of BT-061: Comparison to T cell interacting mAbs

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1 comparison of BT-061 with 14 other anti-CD4 antibodies 2 Ref.: Strand et al. 2007 and cited therein

Clinical Development of BT-061

Clear improvement of clinical symptoms after single application with very low dosages in Psoriasis*

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*75% of the patients received BT-061, 25% of the patients received placebo Status Sept 24th - minimum follow up 28 days

Kinetic of clinical response after single i.v. application in Psoriasis (1 responder)

Patient 11: application of BT-061 or placebo (2nd dose level)

Kinetic of clinical response after single i.v. application in Psoriasis (1 non-responder)

Patient 1: application of BT-061 or placebo (1st dose level)

BT-062: highly potent immunoconjugate for the treatment of multiple myeloma

BT-062 Target

  • • vast majority of MM patients are positive for the target antigen
  • • target antigen highly overexpressed on MM cells

BT-062 Drug:

  • •New generation of immunotoxin
  • •Immunotoxin acts specifically on target cells
  • • gets activated after entering the target cell
  • Minimization of unspecific side-effects

BT-062 - competitive advantages:

  • • BT-062 efficiently kills primary multiple myeloma (MM) cells
  • • but does not kill healthy blood and bone marrow cells
  • • BT-062 significantly reduces tumor size in MM SCID mouse xenograft model
  • • Immune effector functions not necessary in patients

Therapy for immuno-suppressed patients

Company Presentation www.biotest.de 17

BT-062 shows high in vivo efficacy in mouse model after single dose injection

BT-062Development status

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Phase I trial: started 2008

Company Presentation www.biotest.de 18

BT-062 – Clinical Development

Phase I: Dose escalation study in patients with relapsed or relapsed/refractory Multiple Myeloma

Concept

  • •Multi Center trial in 4 US centers, open label, repeated single dose
  • • Primary Objectives:
  • => Dose limiting toxicity
  • => Maximum tolerated dose
  • • Secondary Objectives: Anti-tumor activity Qualitative and quantitative toxicities Pharmacokinetics
  • • Prior therapies Previous treatment with both an immunomodulator and aproteosome inhibitor therapy

Status

  • •3 out of 4 centers are already recruiting
  • • Recruitment of patients for 1st dose level completed - 40 patients are to be enrolled

So far the medication was generally well tolerated by critically ill patients

Monoclonal antibodies development - current status

Financials 2007 &Key figures 1st half year 2008

Biotest AG

Successful 1st half year of 2008

Sales in the first half year (€m)

EBIT in the first half year (€m)

•EBIT rises at faster rate than sales * BPC contribution

  • •Even without BPC, significant rise in sales and profit
  • •Targets for full year: sales of €420 million, growth in EBIT > €50 million

Sales 01-06 2008 in €m

EBIT H1 in €m

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Balance sheet

Assets Equity and liabilities

Company Presentation www.biotest.de 25

Performance of Biotest shares vs. SDAX1st January, 2008 - 23rd September, 2008

Summary: The Biotest strategy

"Biotest – a global specialist in innovative immunology and haematology"

  • •Internationalisation of business – strengthening of the position in the USA in particular
  • •Plasma proteins: new products, new indications and new markets
  • •Capacity expansion
  • •Diagnostics: focus on core markets with high growth potential
  • • Biotherapeutics: achievement of important milestones triggers partnering with global pharma

Disclaimer

This document contains forward-looking statements on overall economics 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 statements and assumes no obligation to do so.

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