Biotest Group: Creating Value.

Living Values

Management Presentation Biotest AG
August 2010 A t

Company Presentation

Biotest AG

This document contains forward looking statements on overall economic forward-looking 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 forward looking obligation to do so. All figures reported relate to the Continuing Operations of the Biotest Group after the disposal of the transfusion and transplantation diagnostic activities to Bio-Rad Laboratories Inc. These activities are being reported as Discontinued Operations. With the exception of the statement of financial position, the previous year´s figures have been adjusted accordingly. All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Company Presentation

Biotest AG


Biotest at a glance
Key Figures: Sales
Thereof Plasma Proteins

FY 2009 € 438.6 m
€ 390.1 m
(+14.2%) (+14.9%) ( (+4.6%) )

H1 2010 € 227.1 m (+4.0%)
€ 200.6 m
(+3.2%) ( (-24.0%) )


€ 61.6 m

€ 23.7 m

Business sectors

Plasma Proteins
• Immunoglobulins • Hyper-immunoglobulins • Clotting factors • Albumin


• Monoclonal antibodies

Microbiological Monitoring
• Hygiene monitoring

Company Presentation

Biotest AG


Biotest Group

• Headquarters in Dreieich/Germany (Frankfurt area) • Subsidiaries in 14 countries worldwide • E l Employees (FTE)* 1 828** (FTE)*: 1,828** Thereof 41% located outside Germany • Founded in 1946, IPO in 1987, SDAX in 2007 , , (preference shares) • Biotest shares: • 6,595,242 ordinary shares • 5,133,333 preference shares
Headquarter, Dreieich
Biotest AG 3

*: as of 30 June 2010

**: Continuing Operations

Company Presentation

Americs. 25% EU (w/o GER). 39% 24./S. August 2010 Biotest AG 4 .Biotest Group overview European production and distribution sites Additional sites overseas: • USA: Florida ( • Japan: Tokyo ( ) ). 2% Germany. 23% Production Sales Asia. 11% RoW. Rockaway ( ) Dreieich (HQ) • Distribution also via 138 distributors in 76 countries Sales by region (H1 2010): N.

About Biotest – strong track record Sales of Biotest Group (in € million)* +102% 481 423 • Strong revenue growth. particularly in Plasma Proteins business • Plasma Proteins account for 81% of Group’s sales in 2009 • EBIT increase by 131% from 2005 to 2009 326 282 238 2005 Company Presentation 2006 2007 2008 2009 *: Biotest Group incl. Discontinued Operations Biotest AG 5 .

4% of total capital.1 mio no voting rights. but higher dividend OGEL GmbH*: KSK Biberach*: Free Float: 50.Shareholder structure Biotest AG Ordinary shares: 6.6 mio with voting rights Preference shares: 5.6% of total capital.03% ~24% ~26% Free Float: 100% 56. and 100% of voting rights 43. 0% of voting rights f i i h * as of August 2010 Company Presentation Biotest AG 6 .

Preference share in SDAX 2010: Divestment of Medical Diagnostics 1946 2010 Company Presentation Biotest AG 7 .Biotest: History and milestones achived 1946: BiotestSerum Institut GmbH G bH 1961: New production facility at Dreieich 1968: First subsidiary outside Germany (Italy) 1971: Market launch of Intraglobin® (polyspecific immunoglobulin) 1987: IPO 1991: Start of Microbiological Monitoring 2004: Start of modernized Plasma Proteins production 1948: TestSerum Anti-D 2007: .Clinical testing g of monoclonal antibodies .Acquisition of Nabi .

Financials H1 2010 Company Presentation Biotest AG 8 .

consistency batches at BPC and regulatory filing for BLA BivigamTM H1 EBIT € 23.H1 2010 – At a glance • • H1 Sales increase + 4.0% to € 227.1 million in difficult market environment Continued influences on EBIT: further price decrease for plasma protein products continued unabsorbed costs in US (finalisation production facility Boca Raton) increased R&D expenses: € 4.7 million (-24%) Revised EBIT Outlook • • Company Presentation Biotest AG 9 .1 million (+19%) incl.

Discontinued Operations: € 45 million +/.10% EBIT Guidance incl.Expectations FY 2010 • • • • • Sales growth in lower single digit range Further p ce p essu es e pec ed for Intratect a d Haemoctin u e price pressures expected o a ec and ae oc Negative impact by German Healthcare Reform Continued unabsorbed costs in US (production facility Boca Raton) (p y ) Shifting of products in higher margin markets not successful EBIT level of 2009 will not be reached New EBIT guidance: € 45 million +/.10% plus € 18 million Company Presentation Biotest AG 10 .

5 H1 2010 Microbiol.1 250 200 150 100 50 0 • Sales in the first half year of 2010 were up by 4.Sales growth despite difficult environment Sales of Plasma Proteins & Microbiological Monitoring (€ m) 218.0 %.0% to 227. H1 2009 • The Microbiological Monitoring segment increased by a rate of 10.3 200.1 H1 2009 26. mainly through products manufactured by heipha • The Group's Plasma Proteins business grew with 3.4 + 3. Monitoring Plasma Proteins Company Presentation Biotest AG 11 .6 + 10 0% 10.2% 3 % 227.0% 24.2% • Robust performance in challenging business environment 194.1 million vs.

6 m Company Presentation Biotest AG 12 .3 194 3 m 20.Sales Plasma Proteins Sales Plasma Proteins H1 2009 S l Pl P i H1 2009 Volume effect  Price effect  Price effect Sales Plasma Proteins H1 2010 Sales Plasma Proteins H1 2010 € € € € 194.9 m ‐14.6 m 200.6 m 14 6 m 200.

EBIT Plasma Proteins H1 2010 vs H1 2009 EBIT Plasma Proteins H1 2009 EBIT Pl P i H1 2009 EBIT from increased volume EBIT loss from reduced prices Net changes of other costs/expenses EBIT Plasma Proteins H1 2010 € € 42.7 m € ‐ 14.2 m 35.6 m € € ‐ 1.6 m Company Presentation Biotest AG 13 .7 m 42 7 8.

7 23 7 ‐ 17 % ‐ 18 % + 32 % + 9 % ‐ 24 % 24 % Company Presentation Biotest AG 14 .8 2.8 23.H1 2010: EBIT Biotest Group (€ m) H1 2009 Plasma Proteins Biotherapeutics Microbiology Corporate Biotest Group Bi G 42.5 ‐ 5.8 ‐ 8.6 ‐ 10.2 31 2 H1 2010 35.3 31.3 ‐ 4.4 3.

2009 2010 EBIT H1 2010 (actual) /\ /\ /\ to 2009 .8 27.Loss in EBIT due to higher R + D Expenses (€ m) vs.8 27 8 R + D Plasma Proteins R + D Microbiology R + D Biotherapeutics increased R+D expenses) EBIT H1 2010  EBIT H1 2010 ( adjusted for  ‐11% 11% Company Presentation Biotest AG 15 .24 % 23.1 0.2 1.7 2.

 Cytotect and others I M C tote t and others Biotherapeutics: Bi th ti 5 Clinical studies  ongoing with BT‐061.BT‐062 and BT‐063 Production Technology transfer of BT‐061 and BT‐062 to Boca Raton Production Technology transfer of BT‐061 and BT‐062 to Boca Raton Company Presentation Biotest AG 16 . regulatory expenses has produced IVIG consistency batches.g. regulatory expenses  for preparartion of BLA submission Dreieich: Intensified development of plasma protein projects e.   IgM.Reasons for increased R & D expenses Plasma Proteins: BPC has produced IVIG consistency batches.

7 by expected growth in 2010 • Higher Trade receivables due to higher sales volumes mainly in the plasma proteins segment Liabilities 322.5 656. Operations Company Presentation Biotest AG 17 .2 308.1 • Higher inventories driven 633.0 656.6%) Non current Non-current assets Shareholders' equity Current liabilities Discont. primarily corresponding to working capital p development 331.1 100 0 30/06/2010 Current assets Non-current liabilities 293.1 656 1 0.5 633 5 9.1 656 1 633.9 308.5 633 5 31. 2009: 42.Strong balance sheet Balance sheet of the Biotest Group (in € million) Assets 700 600 500 400 300 200 Assets A t Liabilities 2.9 121.8 225.8 • Increase in current financial liabilities.5 139.5 308 5 269.8 214 8 • Equity ratio as of 30 June 2010: 31/12/2009 30/06/2010 31/12/2009 47.0% ( 31 Dec.4 225 4 214.

5 million) Successful renewal of working capital facility of € 40 million and new working capital line of € 10 million Further financing available – but at g higher interest rates Purchase price of € 45 million was received on Jan 6th 2010 Jan. 2009: € 204. 180 160 140 120 100 80 60 40 20 0 163.Long term secure debt financing Biotest Group: Maturity of financial liabilities (€ million) ( ) • Total financial liabilities as of 30 June 2010: € 193.9 • <1 year > 1 year Company Presentation Biotest AG 18 .9 • • 29.8 million (31 Dec.

1 .4 45.1 Sale price Net asset disposal Cost of Sale profit restructuring (EBIT) g Taxes Sale profit ( (EAT) ) Company Presentation Biotest AG 19 .3.5 18.0 -15 1.Probable sale profit of €15.0 15.1 million after taxes (EAT) in € million .25.

Outlook for 2010 Company Presentation Biotest AG 20 .

driven by increases in mandatory rebates of additional 10% in public sector and out-patient h t d t ti t hospital sector it l t Transition in Global Plasma Protein market continued price pressure in some markets.10% plus € 18 million) Outlook statements are subject to: Material price and volume movements on core plasma products. slower market growth in some territories Revised Guidance for 2010: Low single-digit percentage sales growth EBIT at € 45 million +/.Outlook for 2010 Reason for revised Guidance: Expected negative impact from anticipated German Healthcare Reform legislation of 5-6 million. pending payments of G d i b li i di f Greece h hospitals and f i exchange rate movements i l d foreign h Company Presentation Biotest AG 21 . changes in healthcare regulation and reimbursement policies.10% (incl. competitor activity. Discontinued Operations: € 45 million +/.

Outlook Plasma Protein Industry Volumes of collected plasma decline again. prices will stablize and the business will continue to grow Company Presentation Biotest AG 22 . overcapacities are being reduced The demand for final products continues Therefore the markets will begin to level out beginning from mid 2011 onwords. Industry consolidation continues.

time on therapy – Better diagnosis and awareness driving increased use and higher dosing – Continued clinical evidence supporting new and emerging indications pp g g g – Growth opportunities in industrialised countries and emerging markets Products often life-saving treatments – long-term demand independent of cyclical effects li l ff t Company Presentation Biotest AG 23 . weight.Outlook Plasma Protein Market Biotest’s business environment fundamentally attractive: Confidence in mid/.long-term growth of plasma proteins products mid/ long term Demand driven by: – Favorable demographics: age.

Further Outlook Biotest Group • Despite difficult business environment we continue to invest into R&D of Plasma Protein Projects and Biotherapeutics • Full pipeline of Plasma Protein products and Biotherapeutics with a potential to reach the market within the next years • BPC/ USA: access to the single biggest plasma protein market Q3 2010 BLA submission of BivigamTM on track Launch of BivigamTM (IVIG) expected to take place in H2 2011 Additional market potential of $ 100 million Company Presentation Biotest AG 24 .

Plasma Proteins Company Presentation Biotest AG 25 .

GRE. I: > 10% Albumin FRACTIONATION Immunoglobulins Hyperimmunoglobulins Clotting Factors • World market leader with Cytotect® and Varitect® • Leading position with Hepatect® in Europe and Nabi HBTM in USA • Zutectra ® launch in Feb. AUT: > 13%. in UK. immune deficiencies Blood coagulation defects = Biotest products Company Presentation = lead indications Biotest AG . CH. distribution vertical i t ti l integration l d t ti leads to rationalisation and higher productivity 26 Intratect® Pentaglobin® Hepatect® Zutectra® Cytotect® Varitect® Nabi HB Hepatitis B Cytomegaly Varicella Haemoctin® Haemonine® HumanAlbumin Biseko Albumin and protein deficiencies Infections. CH. production. 2010 • Biotest covers full value creation chain: plasma sourcing. UK): (GER AUT CH GRE UK) 14% • Intratect® market share in GER.Plasma Proteins business at a glance Biotest Plasma Protein products p • Global market share: 3% Plasma • Market share in relevant markets (GER. AUT.

Major progress in development of Plasma Proteins EU-wide approval (centralised procedure) Approvals in 13 other E th European countries ti (mutual recognition procedure) Approvals in Germany and 10 other European countries Use in fibromyalgia patients: trial completed – scientific publication finalised Biotest AG 27 Zutectra® Hepatect®CP Albiomin® Intratect® Company Presentation .

Development of IVIG markets by regions 140 IVIG global market in [t] 120 100 80 60 40 20 0 2007 2008 2009 2010E 2011E 2012E 2013E USA Europa Europe ROW • The IVIG market will continue to grow (5% p. Biotest Market Research Company Presentation .). Analyst Reports. particularly by increased demand in i emerging markets i k t Biotest AG 28 Source: MRB.a.

L Source: MRB "The Plasma Fractions market in the United States". own estimates Company Presentation Biotest AG 29 .a. C Collected Source Plas sma [MM lit ters] +6 Mio. PPTA. 1996 -2013 +7 % p. 2007.US source plasma collection forecast.

Q2 2010e: Biotest AG Company Presentation Biotest AG 30 .Quarterly volumes of US source plasma Source: PPTA (July 2010).

USA: A highly attractive market for Biotest World s World’s largest market Highest per capita consumption in the world High price levels World market for immunoglobulins Annual per capita consumption (in mg) 150 Rest of  World 30% USA 41% 100 50 Europe 29% 0 USA Biotest AG F UK GER 31 Company Presentation .

(BPC) in Boca Raton.000 litres per annum Immunoglobulin production: 1.US manufacturing plant in operation since end of 2009 State-of-the-art manufacturing facility at Biotest Pharmaceuticals Corp. Florida Fractionation: 400.5 tonnes per annum Plasma collection at 11 BPC-owned plasma collection centres Company Presentation Biotest AG 32 .

BivigamTM (IVIG) development nears successful completion Polyspecific immunoglobulin with a wide indication range (incl. antibody deficiency and autoimmune diseases) A polyspecific immunoglobulin comparable to Intratect® p Clinical development: successful conclusion of phase III Production of stability batches completed Submission of approval documents in Q3 2010. close to successful completion p Sales potential after approval: around $100 million per annum Company Presentation Biotest AG 33 .

0 tonnes of immunoglobulins i l b li Biotest AG Network increases EBIT margin *A Approval will probably b granted end of 2011 l ill b bl be t d d f ** Production in Dreieich and capacities at partners 34 .5 tonnes* of immunoglobulins i l b li Company Presentation Fractionation (1 million litres)** Albiomin (albumin) Albi i ® ( lb i ) Haemoctin® (factor VIII) 4.Plasma Proteins – Efficient production network Biotest Biotest Partners 21 plasma collection centres Level of self-sufficiency: L l f lf ffi i 40% for standard plasma Exchange of intermediate products from US to Europe from end of 2010 Plasma donor stations Plasma donor stations Plasma donor stations Fractionation (400.000 litres) Paste P t V Kryo 1.

e.g.CivacirTM: Attractive project on track Hepatitis C immunoglobulin for reinfection prophylaxis p p y after liver transplantation due to hepatitis C Hepatitis C: frequent cause of liver transplantations Prevalence: 5 to 10 times more frequent than hepatitis B CivacirTM: Project acquired as part of Nabi Biopharmaceuticals takeover p Optimisation of manufacturing process. e g regarding consistency of neutralising antibodies Clinical development expected to be continued in 2011 Company Presentation Biotest AG 35 .

g. Pentaglobin®) Company Presentation Biotest AG 36 .Biotest: A market leader in special preparations Biotest plasma proteins in 2009: sales by product category Hyperimmunoglobulins and special preparations are a very attractive segment: Stable prices High market entry barriers Biotest is totally self-sufficient in hyperimmune plasma procurement * Including special preparations (e.

IgM Concentrate Phase I clinical trial successfully completed IgM-enriched immunoglobulin for emergency treatment of serious bacterial infections (sepsis) Phase II c ca trial to s a from mid o 2011 ase clinical a o start o d of 0 Very high functional activity Good tolerability G d t l bilit Improved raw material utilisation Company Presentation Biotest AG 37 .

000 pregnant women tested so far Interim evaluation planned for end of 2010 Company Presentation Biotest AG 38 .Cytotect®: Trial is progressing Prevention of prenatal cytomegalovirus infection of unborn children whose mothers were infected for the first time during the pregnancy International phase III clinical trial to demonstrate efficacy Extensive immune screening under way (up to 20.000 tests) More than 5.

Zutectra®: EU-wide approval of first hepatitis B immunoglobulin for subcutaneous administration Hepatitis B reinfection prophylaxis after a liver transplantation t l t ti EU-wide approval of new form of administration for hepatitis B immunoglobulin Administered subcutaneously (under the skin) Fast. simple and safe i l d f Developed for self-treatment p Company Presentation Biotest AG 39 . i f F t pain-free.

Hepatect® CP and Zutectra® are an ideal combination Reinfection prophylaxis proph la is after a liver transplantation due to hepatitis B infection Hepatect® CP: Administered intravenously Optimal for intensive treatment during and immediately after transplantation Zutectra®: Optimal for self-treatment Suitable for long-term long term prophylaxis as administered subcutaneously Company Presentation Biotest AG 40 .

2010 • Marketing Approval: aiming for marketing approval in Germany first first.Biotest R&D activity in Plasma Proteins Hepatitis B immunoglobulin (subcunaneous/ intramuscular) p g ( ) in neonates Phase III t i l Ph trial • Status: Recruitment completed • Final Draft of Study Report Dec. international marketing authorisations to follow Company Presentation Biotest AG 41 .

APFA *: Poster: "A European. Cytotect® sc application: Zutectra® Biotest is world market leader in hepatitis B Hyperimmunoglobulin Source: Global Insight. Varitect®. E. weight • Improved diagnosis. multicentre. PPTA. open and prospective study on clinical efficacy. MRB. Zutectra®.. safety. higher dosing level and longer time on therapy • Continued clinical evidence supporting established and new indications 100 50 0 • Geographical expansion Biotest well positioned by diversified portfolio • • • • • Intratect® – a premium product concerning tolerability t l bilit * IVIG available in US 2011 Speciality Hyperimmunoglobulines: Hepatect®. 2006 Company Presentation Biotest AG 42 . Bernatowska et al.Further growth of immunoglobulin market expected IVIG usage [mg] per capita Demand growth driven by 150 • Favorable demographics: age. and pharmacological properties of Intratect® (human normal immunoglobulin for iv administration) in patients with primary immunodeficiency (PID)".

dosing and prophylaxis treatment Biotest Products • Haemonine® (Factor IX) introduced in 2008 Source: WFH. sugar free Haemoctin® has shown to be efficacious in FVIII inhibitor therapy Biotest AG 43 Company Presentation .Opportunities in Haemophilia market Increasing global standards of care 10 FVIII usage [IU] per capita 8 Opportunity 6 4 2 0 Emerging Markets • • • Improving access to care Increasing global penetration of I i l b l t ti f hemophilia therapy Optimization of compliance. PPTA • • • Haemoctin® (Factor VIII) contains high level of von Willebrand factor Haemoctin® is stable at RT for 2 years without artificial stabilisers.

7 H1 2010: € 14. in 25.8 million • Continuous high investments in R&D in Plasma Proteins will guarantee future growth of the Plasma Proteins business • Goal: international regulatory registration and approval for all major Biotest products and intermediates Company Presentation Biotest AG 44 .Biotest R&D activity in Plasma Proteins • R&D expenses in 2009 in the Plasma Protein segment: € 25 7 million.

Biotherapeutics p Company Presentation Biotest AG 45 .

plaque psoriasis BT-062: Multiple myeloma BT-063: Systemic lupus erythematosus Indications with a high medical need for effective and tolerable treatments Antibodies with specific mechanism of action Company Presentation Biotest AG 46 .Biotherapeutics: Attractive development projects BT-061: Rheumatoid arthritis.

8 + 45% + 17% 16. Psoriasis Multiple Myeloma Systemic Lupus Erythematosus 2006 2007 + 25% 20.8 2008 2009 2010e Company Presentation Biotest AG 47 .5 9.7 + 4% 21.2 14 2 BT-062 BT-063 9.Biotherapeutics: Focused research Biotherapeutics: Focused research • High medical need • Rapidly g p y growing markets g • Blockbuster potential R&D expense – Biotherapeutics (in € million) Cap on Biotherapeutics R&D budget Lead indications BT-061 Rheumatoid Arthritis.6 14.

Biotherapeutics: Significant project progress in financial year 2009 and 2010 Research Pre-clinical phase Phase I Phase II Phase III BT 061 BT-061 Rheumatoid arthritis Plaque psoriasis Upside indications BT-062 Multiple myeloma* Solid tumour indications BT-063 SLE 2009 2010 * Phase I/IIa clinical trial approved by FDA (IND) 48 Company Presentation Biotest AG .

7 2.Biotherapeutics: Continuously growing market potential CAGR : CAGR*: 20 13% 17.8 13% 18% 14% Marke volume (bn US$ et e $) 15 2008 2012 10 7.8 10.0 1. Biotest *CAGR: Compound Annual Growth Rate Company Presentation Biotest AG Psoriasis .3 10 3 5 4.1 Systemic Lupus Erythematosus 49 0 Rheumatoid Arthritis *Quelle: Datamonitor.9 39 Multiple  Myeloma 2. Decision Resources.9 3.

BT-061 − Specific mode of action addressing key regulatory function of the human immune system Mode of action offers significant potential in several upside indications Company Presentation Biotest AG 50 .

Rheumatoid Arthritis: Competitive market environment
Favourable positioning is key to success
Cytokine neutralizing (TNFα and others) MoA1) Weakness/  Threats* Neutralization of cytokines of cytokines • Black box warning: risk of infection and malignancy • FDA alert for: invasive fungal infections and increased risk of lymphoma in children • Market dominance Market dominance • Broad safety database  Targeting B cells or T cells Targeting Tregs: BT‐061

Depletion/inactivation of immune Selective activation of Tregs of immune  activation of Tregs cells • Black box warning for PML2) • Increased risk of infection • B‐cell depletion (up to 1 yr) B‐cell depletion (up to 1 yr)  • Severe infusion reactions • Late market entry requires clear USP3) and positioning

Strength/ Opportunity*

• Treatment of TNF non of TNF non responders

• Superior efficacy expected Superior efficacy • Mode of action supports  good safety profile (no   signs of immunosuppression, cytokine release or cytokine release or lymphocyte depletion)

Positioning of BT-061 by new MoA, which translates into superior efficacy and safety

Mode of Action

2) Progressive

multifocal leucoencephalopathy
Biotest AG


Unique selling point *) with respect to individual compounds

Company Presentation

Current clinical data support targeted product
Positioning clear proof-of-concept in both indications Rheumatoid Arthritis
Proof of Concept (POC) Phase II (No. 962 und 971): Ph (N d 971) Mono- and Combinationtherapy • up to 70% improvement of clinical symptoms (ACR70) • good t l bilit d tolerability • Study 962: Final data available • Study 971: Final data expected in Q4 2010

Proof of Concept (POC) Phase I/IIa (No. 967): Ph I/II (N 967) • up to 88% improvement of clinical symptoms (PASI) • long duration of therapeutic effect (up t ( to 90 days after single administration) d ft i l d i i t ti ) • good tolerability Study completed

Potential to pos t o BT-061 via ote t a position 06 a • efficacy • safety • convenient administration (self-administration, every other week, 1 ml subcutaneously)
Company Presentation Biotest AG 52

BT-061 BT 061 in Chronic Plaque Psoriasis:
PASI50 and PASI75 responses after single application
0.5 mg iv 0.5 mg iv 0.5 mg iv
improvement of clinical symptoms (%)

2.5 mg iv

2.5 mg iv

80 60 40
PASI im mprovemen (%) nt

20 0 -20
2.5 mg iv 25 mg sc 25 mg sc 25 mg sc

80 60 40 20 0
Duration of clinical benefit up to 90 days – basis for commercial schedule

day 0 day 5 day 7 day 14 day 21 day 28 day 42 day 56 day 75 day 90

Company Presentation

Biotest AG

Repeated treatment of RA patients with BT-061(monotherapy)
Benchmarking against gold standard of biologic therapy*
ACR responses at week 7, monotherapy 70 60
% of pa atients 67 47 33 20 7 BT-061 10 0 0 Placebo1) 33 17 BT-061 14 13 7 anti-TNF Humira

50 40 30 20 10 0



10 2



Placebo 1)


efficacious dose range most efficacious dose (50-100 mg SC)2) (50 mg SC) (n=15) (n=10) (n=6) (n=14)

marketed dose 3)

1) Two patients from each completed SC dose group; 2) Only patients that received all treatments over the 6 week periode 3) Phase III trial results of anti‐TNF monotherapy in DMARD non‐responders at week 7  *) Please note: data from independent trials are not directly  comparable as patient characteristics, route of administration, dose levels and treatment frequency are different
May 2010 Biotest AG 54

8 weeks t t k treatment. Phase II (973) Goals: − Increase efficacy by completion of dose finding and repeated administration − Benchmarking with biologics gold standard Design: 48 patients i 6 d D i ti t in dose groups. 12 weeks treatment.BT-061: Goals of clinical trials starting in 2010 Higher patient numbers to confirm product profile seen in early trials Psoriasis. 12 weeks follow-up Company Presentation Biotest AG 55 . Goals: − Confirm/establish superior efficacy and tolerability with larger patient basis − Establish Proof-of-Differentiation Design: 175 patients in 3 dose groups. 12 weeks f ll t k follow-up Rheumatoid Arthritis Phase IIb (979) Arthritis.

placebo controlled iv and sc multiple dose. dose Placebo controlled BT-061 + MTX Multiple dose. Placebo controlled Study completed Study completed Recruitment ongoing Study completed Recruitment completed Submitted to regulatory authorities 962 971 979 Phase IIb: Rheumatoid Arthritis 175 Company Presentation Biotest AG 56 . and sc up to 180 mg single dose. placebo controlled Multiple dose. Placebo controlled BT-061 + MTX Multiple dose.Clinical development BT-061 Overview Study no. Indication Design Subjects/ Patients Planned 57 55 48 96 110 Status 961 967 973 Healthy volunteers Phase I/IIa:Psoriasis Phase II: Psoriasis Phase IIa: Rheumatoid Arthritis Phase II: Rheumatoid Arthritis single dose iv.

Biotherapeutics: Established own production capacities Development structures in the segment: GMP production of monoclonal antibodies ( ) established in Boca Raton (BPC) Manufactured first large-scale batches of BT-061 in own production facility Start of GMP production of BT-062 at BPC in 2011 Company Presentation Biotest AG 57 .

BT-061 partnership Negotiations with international pharmaceutical companies ongoing High level of interest Request for confirmation of positive trial results via further phase II clinical trials Biotest strategy: Cooperation with partner from clinical phase III f li i l h Stand-alone further development of mAb until agreement is reached Company Presentation Biotest AG 58 .

Roche/Genentech amongst licensees • First filing of TAP1) mAb expected in 2010 ( (Genentech) ) Antibody moiety mediates high specificity • Unique targeting to CD138 • CD138 highly overexpressed in MM and other cancer cells • CD138 not expressed on bone marrow stroma cells • Good tolerability up to 160 mg/m2 1) TAP: Tumor activated payload 59 Company Presentation Biotest AG .Competitive edge BT-062: Intrinsic properties provide basis for product positioning Toxin moiety mediates high efficacy y g y • High potency independent of patient´s immune system • Toxin technology with best track record: gy Sanofi Aventis. Bayer. Biogen Idec.

BT-062 competitive edge: Specificity and high potency provide potential for competitive positioning Small molecules MoA1) Unspecific cellular toxicity mAbs Specific cellular target Immunoconjugate BT-062 Specific targeting combined with high potency drug Weakness/ Threats AEs in > 30% of patients p • Myelosuppression • Thromboembolic events/ DVT2) • Peripheral neuropathy • Gastrointestinal AEs3) • Dominant market position • Validated targets • Comprehensive safety data base • Dependent on patients p p immune system • Broad tissue expression/ potential cross reactivity • High specificity • Limited safety data basis y Strength/ Opportunity • High potency independent from patient's immune system • High specificity • No myelosuppression and liver toxicity expected 1) Mode of Action 2) Deep Vein Thrombosis. 3) Adverse events 60 Company Presentation Biotest AG .

BT-062: Single-dose study 969 in Multiple Myeloma First efficacy data. August 2010 Number of patients treated with BT‐062* treated with BT 062* efficacy data available  p g ‐ disease progression within 6  weeks ‐ stable disease ≥ 9 weeks ‐ minor response minor response ‐ partial response Total 32 25 11 12 1 1 100% 44% 48% 4% 4% 56% 8% Percentage Objective response Clinical benefit  (%) BT-062 shows anti-tumor activity already in repeated single dose schedule Further patients were enrolled in MTD** cohort up to a total of 13 *Median number of prior chemotherapies: 7 (range: 2-15). 33% of patients had 10 or more prior chemotherapies **MTD: Maximum tolerated dose. Response criteria as defined by International Myeloma Working Group Company Presentation Biotest AG 61 .

Baseline characteristics Patients have been heavily pre-treated. median age of about 65 years and about 6 years median time since initial diagnosis Prior Therapies • All patients have been treated with Bortezomib and at least one Immunomodulator About 70% have been pre-treated with both Lenalidomide and Thalidomide More than 50% have undergone an d autologous stem cell transplantation (ASCT) • • Company Presentation Biotest AG 62 .BT-062: Repeated single dose study 969 in Multiple Myeloma .

BT-062: Next steps Establishment of commercial treatment schemes Phase I/II: Repeated Dosing / Monotherapy – USA (Recruitment started August 2010) Goals: − Selection of commercial treatment scheme − Establish Proof-of-Differentiation in mono therapy g Design: − Up to 70 patients. patients are expected to show improved pre treatments. open label escalation study with intensified dosage scheme − Extension cohort of up to 29 patients Phase II: Repeated Dosing / Combination – Europe (Planned start: 2011) Goal: Establish Proof-of-Differentiation in combination therapy Design: Open label combination study Due to lower number of pre-treatments. response rate and longer duration of benefit Company Presentation Biotest AG 63 .

5 million patients are suffering from SLE worldwide today y Status Phase I • • • Dose escalation in healthy volunteers ongoing 23 volunteers treated So far study medication well tolerated Company Presentation Biotest AG 64 .BT-063: Phase I study on track BT-063 lead indication • • • Systemic Lupus Erythematosus (SLE) High medical need: SLE incurable today today. no new approval since ~ 40 years 2.

Outlook Biotherapeutics: Next steps in clinical development initiated BT-061: • • • • First encouraging clinical data from both lead indications Phase II trial in P i i started Ph t i l i Psoriasis t t d Phase IIb in RA initiated Discussion with strategic partners ongoing BT-062: • First indications of efficacy from dose-escalating study • Multiple dose phase I/IIa trial approved by FDA • Study initiated BT-063: BT 063 • Phase I study approved in Sept. 2009 • Treatment at 7th dose level completed (02 2010) Company Presentation Biotest AG 65 .

Microbiological Monitoring Company Presentation Biotest AG 66 .

heipha.0%.Segment continues to be successful H1 2010 revenue growth of 10 0% achieved mainly by heipha but 10. also Biotest HYCON products contributed to the growth Expansion of logistics capacities at heipha in Eppelheim Investment in research and development p Strengthening of sales structures in the United States and Japan Company Presentation Biotest AG 67 .

Thank you for your attention! Company Presentation Biotest AG 68 .

2011 +49 (0) 6103 .de May 10. 2011 Aug 11.801 -4406 Mar 22.801 -347 investor_relations@biotest. 2011 May 12. 2011 Company Presentation Biotest AG 69 . 2011 Nov 10.Contact and Financial Calendar 2010/2011 Investor Relations Biotest AG: Dr. Monika Buttkereit Head of Investor Relations Phone: Fax: E-Mail: Financial Calendar 2010/ 2011 Nov 08 2010 08. Q3 Report 2010/ Analyst's Conference FY 2010/ Analyst conference Q1 Report 2011 Annual General Meeting Q2 Report 2011 Q3 Report 2011/ Analyst conference +49 (0) 6103 .

Biotest Plasma Proteins − premium products Company Presentation Biotest AG 70 .

Children with congenital AIDS and recurrent infections • Treatment of autoimmune diseases: ITP (idiopathic thrombocytopenic purpura). and Kawasaki Syndrome Properties: • St Storage at room temperature t t t • Ready-to-use solution • Well tolerated (Sugar free) Clinical trials: • • Patients with a primary antibody deficiency Patients with idiopathic thrombocytopenic purpura (ITP) Company Presentation Biotest AG 71 . Primary Immunodeficiency Syndromes 2. Myeloma or chronic lymphocytic leukaemia y y p y 3. Guillainpurpura) Barré-Syndrome.Intratect® Human immunoglobulin for intravenous use (IVIG) Therapeutic indications: Th ti i di ti • Replacement therapy in: 1.

Pentaglobin® / IgM-Concentrate IgM-enriched immunoglobulin for severe bacterial infections Therapeutic indications: • Adjunctive therapy of severe bacterial infections in addition to antibiotic therapy • Immunoglobulin replacement in immunoimmuno compromised patients Properties: • U i Unique i elimination of pathogens and th i in li i ti f th d their toxins • Excellent immunomodulator for controlling inflammation and severe bacterial infections • Excellent tolerability Clinical trial: • I MC IgM-Concentrate i clinical Ph t t in li i l Phase I I: Further developed IgM-enriched immunoglobulin Company Presentation Biotest AG 72 .

needle stick injuries • HBV prophylaxis in newborns from HBV carrier mothers Properties: • Contains high purity anti HBs antibodies anti-HBs antibodies.g.Hepatect® CP Human Hepatitis B immunoglobulin manufactured from plasma of donors with high anti-HBs antibody titres Therapeutic indications: Th ti i di ti • Prophylaxis against hepatitis B (HBV) in adults and children over 2 years who have not been vaccinated and who are at risk of infection • Prophylaxis of HBV re-infection after liver transplantation (g p (gold standard) ) • Prophylaxis after exposure to HBs Antigen positive material. e. standardised to 50 IU/ml • Ready-to-use infusion solution. sugar-free • Natural function and activity of specific immunoglobulins is preserved Company Presentation Biotest AG 73 .

CH) Company Presentation Biotest AG 74 .S. sugar-free Clinical trial: • Phase III study to prevent CMV infection in newborns of mothers who acquired a primary CMV infection during p g g pregnancy y • Orphan Drug Designation (Europe. standardised to 50 U/ml with reference to the standard of the Paul-Ehrlich-Institute • Natural function and activity of specific immunoglobulin i preserved i l b li is d • Ready-to-use solution. patients especially transplant recipients Properties: • Contains anti-CMV antibodies.. U.Cytotect®Biotest Human CMV immunoglobulin manufactured from plasma of donors with high CMV antibody titres Therapeutic indications: • Prophylaxis against the clinical manifestation of CMV infections in immunosuppressed patients.

Haemoctin® / Haemonine® Chromatographically purified. Haemophilia A (Haemoctin®) 2. Haemophilia B (Haemonine®) Properties: • • • • High viral safety standard Stable for two years at room temperature Haemoctin contains a high level of g von Willebrand factor (VWF) Haemoctin has been shown to be efficacious in FVIII inhibitor therapy . double virus inactivated coagulation factors concentrated from plasma Therapeutic indications: • Prevention and treatment of bleeding in: general VWF-containing FVIII preparations are the first choice in inhibitor treatment with high dosages of FVIII. FVIII 75 Company Presentation Biotest AG .

Zutectra® − increased patient compliance Human Hepatitis B immunoglobulin for subcutaneous administration. Manufactured from plasma of donors with high anti-HBs antibody titres. infection occured Biotest AG 76 First subcutaneous injectable HBIG for selfadministration Company Presentation . Therapeutic indication: • Prophylaxis of HBV re-infection after liver transplantation Properties: • Subcutaneous administration – ready for self-administration b patients lf d i i t ti by ti t • Ready-to-use solution in pre filled syringe • High specific anti-HBs activity of 500 IU/ml Safe and convenient HBV re-infection prophylaxis for liver transplant patients Clinical Cli i l results: lt • Protective anti-HBs-serum levels achieved in all patients in the registration trial with weekly Zutectra ® applications no HBV reapplications.

International myeloma working group response criteria Major charcteristics of response criteria* Progressive Disease (PD) Increase of 25% from lowest response value in any one or more of the following: Serum M-component (absolute increase must be ≥0. a ≥50% th d i MP t i bl decrease in the difference between involved and uninvolved FLC levels is required in place of the M-Protein criteria The highest dose level at which < 2 of 6 subjects experience a DLT (Dose Li i i T i i ) i d fi d as the MTD (D Limiting Toxicity) is defined h MTD. Company Presentation .5g/100ml)c and /or Urine M-component (absolute increase must be ≥ 200 mg per 24 h) Not meeting criteria for CR. which still exceeds 200mg 50 89% per 24 h ≥50% reduction of serum M-Protein and reduction in 24-h urinary M protein by ≥90% or to <200 mg per 24 h If the serum and urine M-Protein are unmeasurable. PR or progressive disease ≥25% but <49% reduction of serum M protein and reduction in 24 h urine M protein by 50–89%. VGPR. International Myeloma Working Group. Biotest AG 77 Stable disease (SD) Minor response (MR) in patients with relapsed refractory myeloma Partial response (PR) Maximum Tolerated Dose (MTD) * according IMWG. 2009. Source: Kyle and Rajkumar.

Filling and Packaging Company Presentation Biotest AG 78 . III Paste V Virus removal Virus removal Vi l 3. Purification From Intermediates to Final Bulk Virus inactivation Virus inactivation 4. Plasma Sourcing Plasmapheresis: Plasma collection 2. Fractionation From Plasma to intermediates Donor selection Testing of donations y Cryo Paste II.Plasma Proteins: Production process Virus Safety 1.

v.m.) in $ Others 20% • Use of HBIG after transplantation is mandatory • Biotest is world wide market leader with Hepatect® in Europe and Nabi HBTM in USA Octapharma 1% CSL Limited 3% Grifols 2% Kedrion 5% Korea Green Cross 6% Talecris 12% T l i Biotest 51% • Zutectra® enhances Biotest competence and engagement in the HBIG market strong market position by preventing possible switch to i. Inc.) HBTM already scheduled in attractive world wide markets Company Presentation Biotest AG 79 . & i.m. drugs • Z t t ® will strengthen and d f d current Zutectra ill t th d defend t • F th Launches f Zutectra® and N bi Further L h for Z t t d Nabi (Marketing Research Bureau. and future i.v.Biotest is a mayor player in Hepatitis B Immunoglobulin (HBIG) market HBIG Market worldwide (i.

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