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Biotest AG Investor Presentation 2008

Nov 6, 2008

66_rns_2008-11-06_8daa9545-9dba-4a31-a53a-240cc8bfe6a1.pdf

Investor Presentation

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Biotest AG

Welcome to our Analysts conference

Agenda

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Biotest at a glance Further growth by woldwide sales

  • • Sales Q1-Q3 2008: € 323.0 m Full year 2007: € 326.4 m
  • • EBIT Q1-Q3 2008: € 43.9 m Full year 2007: € 38.5 m
  • •74 % of sales are generated outside Germany
  • •1,893 employees worldwide (FTE)
  • •Plasma Proteins segment 81 % of sales
  • •Total Market Cap € 619.5 m (3 November 2008)

6,595,242 ordinary shares 5,133,333 preference shares

• Family Schleussner (OGEL GmbH) announced plans to sell their ordinary shares

  • Biotest Biotherapeutics
  • Biotest Diagnostics
  • Key Financials (as of 30 September 2008)

Growth Rates of Plasmaprotein Divisions 2007-2008 of Biotest AG and competitors Basis: Turnover in local currency

Source: Business Reports; Basis: local currency

IVIG Market Expectations - Further Growth but at Declining Rates

IVIG - World Market Forecast (Vol.)

World Market Expectations

  • • Continued growth but declining rates (6 - 8 %)
  • • Growth drivers: US and EU market
  • • Highest growth rates in selected emerging markets
  • • Further price increases become increasingly difficult
  • • "We currently do not see a potential supply/demand imbalance until 2nd half 2009" (Morgan Stanley, Jan 2008)

Source: Review of Australia's Plasma Fractionation Arrangements (Feb 2006); Biotest Market Research

Haemophilia Market

  • • The plasma-derived FVIII market is slightly growing
  • increase in consumption per capita
  • improved access to treatment in emerging markets
  • • Haemoctin® is even growing in traditional EU markets like Germany
  • market share of Haemoctin within plasma-derived FVIII products increased from 24% (1HY 2007) to 29.5 % (1HY 2008)
  • • We are going to launch Haemoctin® within the next few months in further highprice EU markets, e.g. in Italy, Portugal, Spain and UK
  • • In Russia Biotest is No. 2 with a share of 21% and roughly 100 million IU
  • • We are going to strengthen the position of Haemoctin in immunotolerance induction by supporting investigator-initiated clinical studies

European plasma protein regulatory approvals

EU procedures completed in 2008:

  • •Hepatect® CP
  • •Haemoctin®
  • •Intratect® (nanofiltration, NF)
  • •Hepatect (nanofiltration, NF)

Additional EU approvals expected end of 2008 :

  • •Haemonine®
  • •Albumin FH

EU approval expected for 2009:

  • •Hepatitis B hyperimmunoglobulin (subcutaneous application)
  • •Intratect capacity expansion

Clinical Studies - Plasma Proteins

Intratect® Chronic idiopathic pain syndrome: Study completed. Immunological predictors for pain reduction are currently analysed. PID:Clinical study with 51 patients has been successfully performed in Europe and confirms the excellent efficacy and the good safety profile of Intratect®. Cytotect® CMV prevention: Currently various measures are undertaken to accelerate recruitment and to facilitate study procedures. 20.000 pregnant women will be screened. BT-088 Human Hepatitis B Immunoglobulin (s.c. application), Liver Transplantation: Study was positively completed and has been submitted for a centralised European authorisation procedure.

Integrationof BPC-Business: Milestones achieved

  • Transfer of Florida Manufacturer License✔
  • FDA licences (BLA, PLA etc.) obtained ✔
  • New management successfully implemented ✔
  • Phase III trial with new IVIG ongoing, on schedule ✔
  • Investment and construction plans for extension of plasma protein and recombinant protein manufacturing established ✔
  • Purchase price allocation and integration of financial numbers in Biotest Group accounting ✔
  • Transfer of clinical, regulatory and drug safety activities from Rockville to Boca Raton finished. New staff hired in Florida✔

Expected sales and earnings according to business plan

  • Biotest Biotherapeutics
  • Biotest Diagnostics
  • Key Financials (as of 30 September 2008)

Focused research:Biotest Biotherapeutics

Three monoclonal antibodies (MAb):

  • •High medical need
  • •Fast growing markets
  • •Blockbuster potential

Biotest MAbs and major indications:

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Expenses for Biotherapeutics [m €]

Biotest monoclonal antibody portfolio (1): Offering unique properties in a high value market environment

Biotest monoclonal antibody portfolio (2): Offering unique properties in a high value market environment

Effect of BT-061 on key regulatory function of the human immune system

BT-061 is unique amongst CD4 mAbs Executive summary

Unique properties amongst anti-CD4 mAbs:

  • •Selectively activates regulatory T cells
  • •Binds to a unique epitope of CD4
  • •Induces a regulatory cytokine

Good safety profile expected:

  • •No activation of conventional T cells
  • •No depletion of lymphocytes
  • •No depletion of T cells

Good tolerability in man

BT-061: Clinical Development

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Study 967: Phase I/IIa single dose escalation in Psoriasis Clear improvement of symptoms after single application

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* per dose group: 75% of patients recieved BT-061, 25% of patients recieved placebo

BT-061's unique mode of action translates into high efficacy already at first dose levels

Improvement of symptoms after single i.v. application in Psoriasis - Three representative patients

Partnering BT-061 with Big Pharma

  • • Biotest has recently initiated discussions with pharmaceutical companies to identify is future partner for the joint worldwide development and commercialisation of BT-061.
  • •Contacts have been established to selected global players.
  • • The list of potential partners resulted from an in-depth evaluation of the companies' pipelines, their global market presence and their expertise in the development of monoclonal antibody drugs.
  • • Each company received in a first step a non-confidential package regarding BT-061 including pre-clinical and clinical data.
  • •Agreement on the final contract is not expected before mid 2009.

BT-062 has unique benefits amongst approved therapies Executive summary

BT-062 Target

  • •vast majority of multiple myeloma patients express target antigen
  • •highly over expressed (50 - 200 fold) on multiple myeloma cells

BT-062 mechanism of action

  • •latest generation of immunotoxins (DM toxins Immunogen)
  • • monoclonal antibody specifically directs immunotoxin to target cells => reduced site effects expected
  • •Cytotoxic effect deployed upon target cell entry

Directed effectivity through combination of antibody with toxic agent

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

BT062 – 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

Status

• First dose level completed - second dose level started about 40 patients are to be enrolled

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

Development of mAB portfolio: Milestone plan

  • Biotest Biotherapeutics
  • Biotest Diagnostics
  • Key Financials (as of 30 September 2008)

Medical Diagnostics - Manual Blood Grouping Reagents launched in the US Market

  • • Spin-off of the Medical Diagnostics business in an independent company realized in January 2008
  • • FDA approval of a complete range of manual blood grouping reagents in August and first sales in September.

Target is a market share of 20% within 5 years (market for transfusion diagnostics in the US ~ \$ 250 Mio)

  • • Tango placements will be doubled in 2008

  • 50 Tangos in the US end of 2008

  • Biotest Biotherapeutics

  • Biotest Diagnostics
  • Key Financials (as of 30 September 2008)

Today's shareholder structure

OGEL wants to sell shares

Financial crisis - impact on Biotest?

Current financing:

  • • Financing in connection with acquisition of Nabi Biologics newly arranged:
  • •€ 135 mio. Long-term financing till 2014 resp. 2015
  • •€ 40 mio. Revolving credit facility for 364 days renewed on Nov. 4, 2008
  • •Current capital expenditures are funded by operating cash flow

Outlook:

  • • In case of economic downturn cost pressure within health care system will increase impact on Biotest uncertain
  • •Consequence: slow down of our expansion plans

Biotest Group: Pleasant growth in Q1-Q3 2008

Revenues Q1-Q3 2007 - Q1-Q3 2008 [ m € ]

Revenues Segment Plasma Proteins: Double digit growth

Revenues 2006 - 2007 [ m € ]

Revenues Q1-Q3 2007 - Q1-Q3 2008 [ m € ]

Biotest Group: EBIT grows stronger than revenues

EBIT Q1-Q3 2007 - Q1-Q3 2008 [ m € ]

Biotest Group: EBIT of segments

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Biotest Group: Balance Sheet

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EQUITY and LIABILITIES

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Biotest Group: Key figures Q1-Q3 2007/2008

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Significant in crease in sales and earnings over the last years

Sales and EBIT in € m

Performance of Biotest shares vs. SDAX 1st January 2008 - 03rd November 2008

Financial calendar & contact

Financial calendar

11 March 2009
23 March 2009
7 May 2009
15 May 2009

11 March 2009 Press conference 200823 March 2009 Annual Report 2008 7 May 2009 Annual General Meeting 15 May 2009 1. Quarterly Report 2009

Contact

Dr. Michael RamrothInvestor RelationsLandsteinerstraße 563303 Dreieich

Tel. + 49 (0) 6103 801 520 Fax + 49 (0) 6103 801 7840

[email protected]

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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