Post on 30-Dec-2015
2
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
3
The 25 Major BVT Shareholders
4
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
5
Board of Directors
Håkan ÅströmChairman
Mats-Olof Ljungkvist
Wenche Rolfsen
Michael Steinmetz
Hans Wigzell
CatarinaLarsson
Bo-GunnarRosenbrand
Hans Glemstedt
Peter Sellei
Company Organization
6
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
7
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
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
10
Growth Through Geographical & Portfolio Expansion
11
• 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
12
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
13
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
14
• 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)
15
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
16
17
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
18
19
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