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Biotest AG Investor Presentation 2009

Nov 5, 2009

66_ip_2009-11-05_c75c7650-e2db-4fcc-9e83-945c50af5abf.pdf

Investor Presentation

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Biotest Group: Creating Value. Living Values.

Analyst Conference – Q1-Q3 2009 Frankfurt/Main, November 5, 2009

Disclaimer

This document contains forward-looking statements on overall economic 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.

All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

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 Group: Creating Value. Living Values.

Plasma Proteins

Current market environment and pricing situation for polyspecific immunoglobulins

  • • Total volume IVIG world market as of 2008: ~90 tons
  • • USA by far the most important market for IVIG worldwide

Current Market trends

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Sources: MRB, APFA, UBS, Biotest Market Research

IVIG world market 2007:

volume (in tons) and

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

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  • • Closing of first plasma collection centers in the US
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  • • 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

Status Projekt IVIG and Boca Raton (USA)

•IVIG clinical Phase III

  • Clinical p yp hase III stud y com pleted
  • Finalization of clinical study report in Dec. 2009

•Enlargement of production facility

  • 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
  • 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

Biotest received positive opinion for Zutectra ®

Human Hepatitis B Thera immunoglobulin (HBIG) manufactured from plasma of donors with high anti-HBs antibody titres y Pro

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
  • • Further Launches for Zutectra® and Nabi HBTM already scheduled in attractive world wide markets

Two ideal therapies designed for acute and maintenance treatment

….. with proven efficacy and safety

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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
  • •Presence in the U.S. market extended
  • • 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 Group: Creating Value. Living Values.

Biotherapeutics

Clinical development BT-061 Overview

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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)*

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*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 (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 Higher response 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/IIa trial, a US- based multidose trial (Phase II) has been submitted in October 2009

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

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. Financials Q1-Q3 2009

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

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)

Sales continue to increase, EBIT increase at lower rate

EBIT (in € million)

Plasma Proteins business drives EBIT

EBIT by segments (in € million)

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  • • 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

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

Thank you for your attention!

Biotest Group: Creating value Living values value. values.

Analysts Conference

Contact and Financial Calendar 2010

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