Sobi: Update and Perspective. June 2014

Transcription

1 Sobi: Update and Perspective June 214

2 Forward Looking Statements In order to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995, Swedish Orphan 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 Swedish Orphan 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. 2

3 An International Specialty Healthcare Company Dedicated to Rare Diseases 1. Diverse, growing, and profitable base business focused on rare diseases Significant geographic and product growth within current portfolio 2. Near-term first-to-market long-acting Haemophilia factors with exclusive $3.7B territory in Europe+ Strong development partner in Biogen Idec, currently launching in the US 3. Pipeline of rare disease biologics Novel inhibitor of complement factor C5 with a weekly subq injectable profile in Phase I 3

4 Quick Facts Market Cap: $3.57 Billion USD (SEK 23.1 Billion) Share: 27 May 214: SEK week range: SEK Listing: NASDAQ OMX (STO:SOBI) Outstanding shares: 27.4 M International Presence 55 employees Sales and marketing organization which covers about 2 countries in Europe Growing organizations in US, Russia, Middle East Ownership Summary: 3 April 214 9% 19% 4% 3% 1% 64% Sweden United States United Kingdom Luxemburg Switzerland Rest of World 4 USD 1 = SEK 6.46

5 A Diverse, Growing Business Platform Revenues FY 213 = USD 323 M Early Stage Development Programmes Haemophilia Medium term investments to support commercialisation of the late stage Pipeline Inflammation USD 83 M Genetics & Metabolism USD 67 M Continued focus on growth in key Therapeutic Areas Partner Products USD 81 M An integrated solution for commercialisation of niche and specialty products ReFacto AF USD 92 M Stable contribution to revenues from drug production and royalties 5 USD 1 = SEK 6.46

6 Highlights Q1 214 Financial Q1 214 (Q1 213) Total revenues: USD 89 M (82) An increase of 8% Product revenues: USD 63 M (53) An increase of 18% Gross Margin: 56% (57) -2 EBITA: USD -45 M (9) EBITA excluding Kiobrina write-off USD 6 M Q4-13 Q1-14 USD 1 = SEK

7 Net Debt USD M % 6% 5% End of quarter cash position: USD 89 M Stronger sales + improved debt collection Net debt USD 34 M % 3% 2% Kiobrina Write-Down USD 48.6 M Inventory + Goodwill ~ USD 45 M Cash effect ~ USD 3.6 M 1 1% Q2-12 Q3-12 Q4-12 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 % Net Debt Net Debt/Equity 7 USD 1 = SEK 6.46

8 Outlook 214 Revenues SEK 2,3 to 2,5 M (USD 356 M to 387 M) Gross Margin 58-6% Operating costs Operating costs are expected to increase as the company continues to prepare for the planned launch of the Haemophilia programmes. The outlook was first published in the 213 Q4 report on 2 February USD 1 = SEK 6.46

9 Strategic Priorities 1. Near-term focus on growth in key therapeutic areas, with sustainable positive cash flow from operations. We are here 2. Medium-term investments to ensure successful commercialization of our late-stage pipeline. 3. Long-term growth will come organically and through acquisitions in key therapeutic areas. 9

10 M USD Results in Perspective: : Adjusted EBITA USD -3 M Non-recurring USD 12 M 35 (restructuring) Multiferon USD -22 M : Adjusted EBITA USD 14 M Non-recurring USD 5 M (Arexis) Co-promotion Pfizer USD -45 M GM 59% GM 51% GM 54% USD 1 = SEK Total revenues Gross profit EBITA Adjusted EBITA 4 2 1

11 Near-Term First to Market Haemophilia Franchise EBITA Short-term Medium-term Long-term Early Programmes Haemophilia Haemophilia royalties Genetics & Metabolism Inflammation Partner Products ReFacto TIME 11

12 Operating Portfolio Momentum Orfadin (USD) Kineret (USD) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Quarterly Orfadin 4Q-rolling Quarterly Kineret 4Q-rolling Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Manufacturing Royalty Refacto 4Q-rolling USD 1 = SEK ReFacto (USD) Partner Products (USD) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Co-promotion revenues Discountinued products Base Portfolio Base Portfolio 4Q-rolling

13 Evolving Position of Kineret in IL-1 Diseases RA Patients with Co-morbidity Where Kineret s short half-life + safety profile uniquely suitable High Rrisk Pts on Biologicals 1 (2 ) Dynamic Patients 2,3 (1 ) Prone to Infections 1 Datamonitor 21 2 IMS Health Opticom MR EU 27 and US (est) CV Diabetes Kineret Opportunity = 1. FYP 4 Pediatric Inflammation NOMID approved in US YE 212 CAPS approved in EU in 213 Growing interest for role of IL-1 Gout Post-myocardial infarction heart failure Stroke Skin disease (hidradenitis suppurativa, acne) Type 1 & 2 diabetes Dry eye syndrome Malignancies Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases Charles A. Dinarello, Anna Simon and Jos W. M. van der Meer, Nature Reviews, Aug,

14 Taking Orfadin Direct in the Americas

15 Strong Partnerships + Dedicated Platform 15

16 Building a Leading European Haemophilia Platform Haemophilia Factor 9 Fc (Alprolix in the US) Approved in Canada Approved in US Paediatric studies underway in Europe European launch expected 2H 216 Factor 8 Fc (Eloctate in the US) Positive KIDS-A-LONG data Q1 214 US Approval expected MY 214 European filing expected 2H 214 European launch expected 2H

17 Fc Fusion Technology Well Understood rfixfc Model of rfixfc Enbrel (etanercept) Orencia (abatacept) Nplate (romiplostim) Arcalyst (rilonacept) Amevive (alefacept) rfviiifc Model of rfviiifc 1Summary of product characteristics of BeneFIX (Nov 18, 29) 2 Blood 211 blood ; published ahead of print November 22, 211, doi:1.1182/blood /16 PTPs were included for PK analysis (1 subject did not complete PK profiling); In press, Blood

18 Long-Acting Factors: Shifting the Curve ILLUSTRATION ONLY NOT DATA 3X per week 2X per week 1X per week Relative Number of Patients Number of Infusions Per Week

19 Haemophilia A+B Sales in Sobi Territory $3.7B Sales in Sobi Territory

20 Factor Use for Prophylaxis High in Sobi Territory Patients on Prophylaxis Consume Majority of Factor Patients Prophylaxis Units On Demand 2

21 Longer Lasting Agents Most Appealing Improvement, Likely to Generate Switch Rank the importance of the following attributes for coagulation factors in development, and the likelihood to propose a switch (from 1 to 1) Very high 1 9 High Average Low Very low Longer lasting agents Subcutaneous administration Lower price Better dose adjustment of vials Importance Likelihood propose switch SOBI Hemophilia Care-211 European Market Mapping 21

22 Novel Therapies have Major Impact on EU Treatment Choice Minor improvements result in changes within exisiting classes Market share % by volume, the EU Market: 1% FVIII Recombinant Plasma Recombinant 1% FIX 8% 8% 6% 6% 4% 4% 2% 2% % % 22

23 Fewer than 1 Haemophilia Reference Centres 23

24 Pipeline of Rare Disease Biologics Indication Project Partner Pre-Clin. Phase 1 Phase 2 Phase 3 Launch Hemophilia A rfviiifc Hemophilia B rfixfc Oral Mucositis in Head & Neck Cancer Hereditary Tyrosinaemia type 1 Hereditary Tyrosinaemia type 1 Alkaptonuria Kepivance Orfadin Liquid Orfadin 2mg capsule Orfadin Complement Factor C5 SOBI2 Enzyme Replacement Therapy IL-1-driven disease SOBI3 IL-1 Affibody Pipeline Projects LCM with Approved Products Product about to be launched 24

25 Pipeline of Rare Disease Biologics Indication Project Partner Pre-Clin. Phase 1 Phase 2 Phase 3 Launch Hemophilia A rfviiifc Hemophilia B rfixfc Oral Mucositis in Head & Neck Cancer Hereditary Tyrosinaemia type 1 Hereditary Tyrosinaemia type 1 Alkaptonuria Kepivance Orfadin Liquid Orfadin 2mg capsule Orfadin Complement Factor C5 SOBI2 Enzyme Replacement Therapy IL-1-driven disease SOBI3 IL-1 Affibody Pipeline Projects LCM with Approved Products Product about to be launched 25

26 Key Events Calendar * Kepivance HNC FDA meeting Fc8 paediatric data Fc8 US launch Fc8 opt-in SOBI2 phase 1 data 214 Q2 Q3 Q4 Q1 Q2 215 Orfadin direct sales in NA Fc9 US launch Fc9 paediatric data 26 * Timing for all events is indicative

27 Summary 1. Diversified commercial portfolio focused on improving cash flow and profitability 2. Working to efficiently commercialize our proprietary innovative medicines for rare disease patients globally 3. Business model oriented to building value through partnerships from global early stage biologics development to late stage specialty distribution in Europe 27