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Biotest AG — Investor Presentation 2006
Mar 20, 2006
66_rns_2006-03-20_0d94bacc-2e83-4f7c-a827-ac2012447e10.pdf
Investor Presentation
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Focussed research, global growth.


Milestones in 2005
- Development of monoclonal antibodies is on schedule Clinical trials with BT-061 will be continued in 2006
- European approval (Mutual Recognition Procedure = MR) of Intratect® in 9 countries
- Cytotect Biotest demonstrates high efficacy in treatment of cytomegalie infections in pregnancy (New. Engl. J. Med.)
- Inspection and approval of our new production lines by the German authorities:
- Biseko: July 2005
- Factor IX: October 2005
- Launch of TANGO in USA October 2005 - 155 Systems are already in the international markets
- Important milestones for implementation of new corporate identity and change of management culture have been achieved

Worldwide plasma market including recombinant products


Worldwide need of immunoglobulins

MRB-Report: Feb 2005

Polyspecific immunoglobulins - High demand: Price increase


German hospital market: Biotest increases market share with Intratect

Source: IMS MIDAS, Sept 2005; MRB Europe 2002

German retail market*: Sales increase of Intratect


Total volume FVIII (Plasma derived and recombinant)


Plasma vs. recombinant Factor VIII market share per region


Biotest plasmatic Factor VIII market share in Germany


Biotest plasmatic Factor VIII – market share worldwide


Focussed research, global growth.
Growth potential plasma proteins
Immunoglobulins




Intratect® ongoing successful sales record
- Intratect sales in Germany pushed up revenues of polyvalent immunoglobulins by ~ 50 %
- MR*-Process successfully concluded in October 2005
- Approval in 9 European countries including UK and Italy with high demands
- Start of Sales in major European countries in 2006

* MR = European Mutual Recognition Procedure

Intratect® market entry Europe - present status
| June 2005 |
Sept 2005 |
Dec 2005 |
Jan 2006 | II. - IV.Q 2006 |
|---|---|---|---|---|
| Submission Marketing Authorization in |
MR Approvals |
National Approvals in |
National Approvals in United |
National Approvals expected in Belgium, Czech Rep., |
| Russia | Austria, Hungary, |
Kingdom, Ireland |
Greece, Italy, Poland, the Netherlands |
|
| Product Launches in |
Product Launches expected in Austria, Belgium, |
|||
| Hungary, Ireland, United Kingdom |
Czech Rep., Greece, Italy, Poland, The Netherlands |

UK market dominated by BPL, Octapharma and Grifols – Biotest plans to sell about 100 kg Intratect®


Intratect® sales perspectives in major European markets
| 2006 | 2007 | 2008 | 2009 | 2010 | ||
|---|---|---|---|---|---|---|
| Germany | ||||||
| Sales (kg) | 480 | 500 | 520 | 530 | 530 | |
| European Markets | without Germany |
|||||
| Sales (kg) | 250 | 1,000 | 1,390 | 1,680 | 1,950 | |
| Total (kg) | 730 | 1,500 | 1,910 | 2,210 | 2,480 |

Successful treatment with Cytotect® Biotest during pregnancy
- Large-scale clinical trial concluded significant reduction of severe malfunctions of unborn children (New Engl. J. Med.)
- Conventional drugs cannot be used (side effects)
- Market Potential:
21,000 infections during pregnancy e.g. in Europe. Estimated market potential € 33 m.
- Orphan drug status will be applied for July 2006
- Consensus conference of German gynaecologists on CMV screening and therapy of cytomegalie infections during pregnancy in May 2006


Registration of plasma products in Europe


Chromatographie-Anlage New plasma protein plant nearly completed
- CAPEX end of 2005, ~ € 75 Mio.
- Fractionation Capacity 700,000 l
- Production Capacity Factor VIII / Factor IX ~ 400 Mio. Units
- Extension of Chromatographic Purification to 4,000 kg Immunoglobulins will start in 2006 Additional Investments ~ € 9 Mio.


Biotherapeutics: Monoclonal antibodies Focussed research, global growth.

Biotest Biotherapeutics
- Three monoclonal antibody (MAB) projects
- Unique mode of action
- High medical need
- Fast growing markets
- Blockbuster potential
- Proof of concept and safety have been demonstrated in early clinical trials for MABs BT-061 and BT-063
Biotest MABs and major indications
| BT-061 | Rheumatoid Arthritis Psoriasis |
||
|---|---|---|---|
| BT-062 | Multiple Myeloma | ||
| BT-063 | Systemic Lupus Erythematodes and other Autoimmune Diseases |

BT-061 provides different functional properties than other monoclonal antibodies against T-cells
- Target structure: CD 4 on regulatory T-cells
- not CD 28 (target of Te Genero´s Super MAB® )
- Batches of the murine and humanised antibody produced at Diaclone in Besancon were already tested in clinical trials. They displayed good tolerability in clinical investigations.
- In 114 patients with Rheumatoid Arthritis and Psoriasis no single report of a severe adverse event has been reported.
- Good safety profile in a primate study

Important milestones achieved - Production of new clinical antibody material (GMP Grade) almost completed.
BT-061: Milestones in 2005
Preclinical Development • Further safety studies - Biomedical Research Center, Rijswijk - Academic Medical Center, Amsterdam • Further mechanistic studies - Karolinska Institute, Stockholm - Prof. St. Remy, Leuven Clinical development Clinical batch production & preclinical development Clinical Development • Protocol definition and selection of clinical centers • Scientific advice meeting with regulatory agency (Paul Ehrlich Institute) Contract manufacturer (Lonza) • Change of production system to achieve favourable COGs • Development of process for large scale production • Pilot Batches available

In 2006 the production of new antibody material has been completed. Clinical development will be continued.
BT-061: Milestones in 2006


In 2006 clinical development will be continued. Phase I is planned in Psoriasis, Phase II in rheumatoid arthritis.


Therapy of rheumatoid arthritis: Global markets grow by 33% per year.
- Biologics will account for > 80 % of market volume in 2008
- CAGR (biologics) = 44.8 %
- Biologics consist mainly of TNF• antagonists
- 20 30 % of patients do not respond to TNF• antagonist therapies 2,500


Development of BT-062 is on schedule: First production of antibody material successfully completed.
BT-062: Milestones prior to clinical development


Therapy of multiple myeloma: Biotest investigates further indications to utilise BT-062´s full potential.


Focussed research, global growth.
Extension of diagnostics business



R + D activities diagnostics
- Development of a new generation of air sampler (RCS Systems) for hygiene monitoring
- Development of array-based DNA typing systems ("chip technology") for transplantation diagnostics and other areas
- Regulatory approval of manual reagents for transfusion diagnostics in North America:

Canada: 2nd quarter 2006

USA: Clinical trials ongoing – regulatory approval 2nd quarter 2007

Marketing + Sales: TANGO
- Launch Tango Optimo USA: October 2005
- 21 Tango Optimo Systems sold to Olympus in 2005
- 16 Tango Systems placed in Germany in 2005
- Total Placements in 2005: 51 Tangos
- Total Number of Systems in the Market (12/2005): 155


Outlook 2006
Forecast
- Revenues expected to increase by 8 10%
- Operating profit will go up again despite higher R&D expenses in Biotherapeutics
Pharmaceuticals
- IVIG, Hyperimmunglobulines and F VIII Sales expected to grow further on a European scale – reduction in tender markets more than compensated
- After the Approval of new products, the technical advantages of new production site will have a stronger impact on our profit in 2006
- Prices for plasma products will further stabilize and slightly improve in H1 2006
Diagnostics
- Additional TANGO® optimo sales in the US First sales of manual reagents in Canada
- Heipha well positioned for accelerated growth