swedish-american life science summit 2009. 2 in order to utilize the ‘safe harbor’ provisions of...

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Swedish-American Life Science Summit 2009

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Swedish-American Life Science Summit 2009

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In order to utilize the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, Biovitrum is providing the following cautionary statement. This presentation contains forward-looking statements with respect to the financial condition, results of operations and businesses of Biovitrum. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of delay to new product launches; the difficulties of obtaining and maintaining governmental approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; and the risk of environmental liabilities.

DISCLAIMER

Biovitrum Highlights• Swedish based specialist pharmaceuticals company

– R&D, manufacturing and product sales– 400 employees, whereof 170 in R&D

• International commercial presence– Europe, US, Canada, Australia & New Zealand

• Eight marketed specialist pharmaceutical products

• Six Phase II specialist indication protein pharmaceutical pipeline projects

• Strong biotech therapeutics heritage

• Solid financials– Revenues SEK 1.14 billion (2008)– Cash position SEK 460 million (2008)

• Listed on the SSE with MCAP BSEK 3.3

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The 25 Major BVT Shareholders

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VPC data per 2009-05-29

Share holder Number of shares Share %

INVESTOR AB 11 447 307 22,9MPM 9 446 214 18,9AMGEN INC 3 768 516 7,5MERRILL LYNCH, PIERCE, FENNER & SMITH, W9 3 511 205 7,0ORKLA ASA 2 650 000 5,3MSIL IPB CLIENT ACCOUNT 2 546 385 5,1Skagen fonder 1 843 726 3,7CBJER-KBCI FOR H&B CAPITAL LP 1 826 091 3,7LIFE EQUITY SWEDEN KB 1 826 091 3,6AAC CAPITAL 1 506 524 3,0Catella Fondförvaltning 1 064 156 2,1Handelsbanken fonder inkl XACT 804 725 1,6SEB Investment Management 628 642 1,3NORDEA BANK NORGE NOMINEE 603 220 1,2FJÄRDE AP-FONDEN 444 682 0,9GLADIATOR 350 000 0,7BIOVITRUM TREASURY AB (C-shares) 284 000 0,6Danske Capital Sverige AB 282 162 0,6STIFT FÖR FRÄMJANDE&UTVECKLING 271 662 0,6Swedbank Robur Fonder 256 773 0,5

DNB NOR Bank ASA 209 200 0,4CEO and Management 138 900 0,3

Others 4 285 347 8,6Total 49 995 528 100,0

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Board of Directors

Håkan ÅströmChairman

Mats-Olof Ljungkvist

Wenche Rolfsen

Michael Steinmetz

Hans Wigzell

CatarinaLarsson

Bo-GunnarRosenbrand

Hans Glemstedt

Peter Sellei

Company Organization

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C F OG öran A rv idsson

E xecu tive A ss is tantE lisabeth B runnander

C o rpo rate Develo p m entH ans Ö rström

C o rp o ra te C om m u n ica tio nsE rik K innm an

L eg al & Inte llec tu al P rop ertyF red rik B e rg

H u m an Reso urcesM aria Be rgg ren

R esearch & D eve lo pm ent

P e te r E dm an

M anu factu rin g &Q A /AC

H ans Ö rström

S a les & M arke ting

H e lena R udberg

C E O

M artin N ick lasson

~175 FTEs ~ 150 FTEs ~ 25 FTEs

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Senior Management

Mara Berggren Hans Örström Erik Kinnman Martin Nicklasson Fredrik Berg Peter Edman Göran ArvidssonHead of HR SVP Commercial VP IR & PA, CEO General Counsel CSO CFO Operations Chief Strategic Officer SVP Legal

BIOVITRUM - ENTREPRENEUR WITH BIG PHARMA EXPERIENCE

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Biovitrum’s Commercial Portfolio is Focused on Rare Diseases/Orphan Drugs

Sustainable and Well-founded Growth Strategy

• Expand commercial portfolio and geographical presence– Kineret®, Kepivance® and Stemgen® acquired Dec 15, 2008

• Leverage recombinant protein therapeutics expertise in a focused and flexible R&D organization

• Deliver specialist indication value propositions from our R&D pipe-line– Hemophilia

– Fat malabsorption

– Autoimmune diseases/Inflammation

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Growth Through Geographical & Portfolio Expansion

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• Infrastructure organization and network in Europe/North America/Australia/New Zealand

– Marketing and sales, including proactive call centers

– Distributors and wholesalers

– Medical support

– Pharmacovigilance

– Warehouses for the acquired inventory and cell banks

Product portfolio expansion

Partnering/distribution Kineret & Kepivance

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Strong rDNA Biopharmaceuticals Heritage

• Sole global manufacturer of ReFacto® AF drug substance

• Manufacturing processes for 6 products developed to market

• More than 30 processes developed and manufactured for clinical phase

– Big Pharma (Pfizer, Amgen, Wyeth)– Small/Mid sized biotech companies (e.g.

Symphogen and Syntonix) • High quality CMC work enabled first clinical

recombinant polyclonal antibody ever

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Biovitrum’s Pipeline is Focused on Rare Diseases/Orphan Drugs

Product Disease Indication Partner Phase Region *Hematol. FIXFc Hemophilia B Biogen Idec I/II Global

FVIIIFc Hemophilia A Biogen Idec Preclin Global

Malabs. Kiobrina™ Fat malabsorption in premature infants   II Global

Exinalda™ Fat malabsorption in cystic fibrosis   II Global

Auto immune

Sym001 Rh-immunization Symphogen II ** Global

Sym001 Platelet disorder (ITP) Symphogen II Global

Cancer support.

Care

Kepivance® Oral mucositis after chemotherapy and radiation - pediatric (1-16 yrs) indication

  I/II Global

* Region in which BVT has the rights to sell and promote** A dose adjusting red blood cell challenge healthy volunteer study preceding phase III

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• Many specialist indication areas with high unmet medical needs– Segment enjoys higher growth cf. crowded primary care arena

• Less R&D risk– Validated targets

– No huge development programs

– Biovitrum biotech therapeutics competence and specialist pharmaceuticals portfolio leverage

• Rare disease drug development supported by regulators, government funds and charitable foundations

– 5-8.000 ‘orphan’ diseases affecting 6-8% of the population

• 400 can be offered treatment

– Market exclusivity (10yrs EU, 7yrs US)

– Fee waivers, fast track/expedited review processes and protocol assistance

• Access to market segments is more favorable– Marketing & sales more focused and less costly as patients and care givers can be reached at few centers

Why Specialist Indications/Rare Disease Focus?

Q2 Showed Continued Strong Revenue Growth

• Revenues before licensing revenues increased by 31% to 319.9 MSEK (243.8)

• Kineret® and Kepivance® revenues were 137 MSEK (16.2)

• Earnings 16.8 MSEK (-98.6)

– …equivalent to earnings per share 0.33 SEK (-2.12)

• Strong cash flow from operations 45.1 MSEK (-75.6)

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Q2 Showed Good Pipeline Progression

• ReFacto AF® was launched in Europe June 1

• One of two phase II Kiobrina studies, and an Exinalda PoC study, completed patient recruitment

• Good Sym001 phase II study progression

• 2 metabolic disease projects out-licensed to iNovacia AB

Events after Q2• Distribution agreement for Israel entered with Megapharm Ltd

• American Depository Receipt program launched with The Bank of New York Mellon

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Key Figures YTD June 2009

Amounts in SEK million 2009 2008 2009 2008

Total revenues before license revenues 319.9 243.8 675.1 443.8

Profit/loss for the period 16.8 -96.6 1) -6.9 -98.7 1)

Earnings/loss per share before dilution 0.33 -2.12 1) -0.14 -2.16 1)

Research and development expenses 162.2 167.7 306.0 338.6Liquid funds and short-term investments 341.2 635.6 341.2 635.6

1) Amount including restructing expenses of SEK 120.0 M.

Jan 1 - Jun 30Apr 1 - Jun 30

2009 – Prioritize Delivery

• Deliver the topline– Kineret®, Kepivance®, Stemgen®

– Optimize the ReFacto/XynthaTM business

– Grow the sales in the Nordic region

• Ensure future growth– Strike new partnership agreements for Kepivance® and Kineret® in new regions

– Identify new product acquisitions and/or business partnerships

– Progress the project pipeline

– Out-license/sell the small molecule pipeline

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Compelling Investment Opportunity

Integrated specialty pharma playerIntegrated specialty pharma player

Low risk and diverse stable cash flowsLow risk and diverse stable cash flows

Growth and expansion platformGrowth and expansion platform

• Broad specialist pharmaceuticals portfolio

• Integrated R&D, manufacturing and M&S organization

• Industry leading protein pharmaceuticals and hemophilia expertise

• Broad specialist pharmaceuticals portfolio

• Integrated R&D, manufacturing and M&S organization

• Industry leading protein pharmaceuticals and hemophilia expertise

• Significant sales and EBITDA generated by products sales, co-promotion, royalties and manufacturing services

• Compelling valuation and strong financial profile with significant upside

• Expanded commercial organization and portfolio enhancing attractiveness for additional product partnerships

• Significant sales and EBITDA generated by products sales, co-promotion, royalties and manufacturing services

• Compelling valuation and strong financial profile with significant upside

• Expanded commercial organization and portfolio enhancing attractiveness for additional product partnerships

• Self-funded R&D player with valued protein pharmaceuticals development/production and partnerships

• Strong balance sheet allowing strategic flexibility

• Opportunity to acquire and in-license new products

• Self-funded R&D player with valued protein pharmaceuticals development/production and partnerships

• Strong balance sheet allowing strategic flexibility

• Opportunity to acquire and in-license new products