Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Shareholder Meeting (May 2014)
34 slides from Swedish Orphan Biovitrum Ab's shareholder meeting presentation, May 8, 2014
Slide 1: Swedish Orphan Biovitrum AB Annual General Meeting 2014
Swedish Orphan Biovitrum AB Annual General Meeting 2014 Geoffrey McDonough, CEO and President Stockholm │ 8 May 2014
Slide 2: Sobi is an international specialty healthcare company dedicated to rare diseases
Sobi is an international specialty healthcare company dedicated to rare diseases Our key therapeutic areas are Inflammation and Genetic diseases, with a growing focus on Haemophilia. We deliver products to specialist physicians and their patients through our integrated and focused team approach to s
Slide 3: Quick Facts Today
Quick Facts Today Market Cap: $3.2 Billion USD (SEK 20.8Billion) International Presence Share: Close May 2, 2014: SEK 76.75 • 550 employees 52-week range: SEK 36.80 – 87.20 • Sales and marketing organization which covers about 20 countries in Europe Listing: NASDAQ OMX (STO:SOBI) • Growing organisat
Slide 4: 2013 Highlights
2013 Highlights Commercial Development • Acquired the full commercial rights for • Announced novel Complement C5 Kineret® from Amgen inhibitor program to enter phase 1 • Signed partnership agreements with: (SOBI002) • Auxilium Pharmaceuticals for the development • Acquired additional phase 3 data fo
Slide 5: Consolidated Results Full Year 2013
Consolidated Results Full Year 2013 2 500 Financial Highlights 2,177 • Total revenues: SEK 2,177 M (1,923) 2 000 1,923 • an increase of 13% • Product revenues: SEK 1,558 M (1,344) 1 500 • an increase of 16% 1,284 SEK M • Gross Margin: 59% (54) 1,040 1 000 • EBITA: SEK 211 M (367) • Cash Flow from op
Slide 6: Net Debt
Net Debt 500 50% • Operating business is cash flow positive 400 40% • Cash Position SEK 445 M 300 30% SEK M 200 20% 100 10% 0 0% Q4-12 Q1-12 Q2-12 Q3-12 Q1-13 Q2-13 Q3-13 Q4-13 Net debt Net debt / Equity 6
Slide 7: A Diverse, Growing Business Platform
A Diverse, Growing Business Platform Early Stage Development Programmes Medium term investments to Haemophilia support commercialisation of the late stage Pipeline Genetics & Inflammation Continued focus on growth +16% SEK 562 M Metabolism +3% in key Therapeutic Areas SEK 450 M Partner Products An in
Slide 8: Evolving Position of Kineret in IL-1 Diseases
Evolving Position of Kineret in IL-1 Diseases RA Patients with Co-morbidity Pediatric Inflammation Growing interest • Where Kineret’s short half-life + for role of IL-1 safety profile uniquely suitable • Gout High Rrisk Pts on Biologicals1 • Post-myocardial infarction (200 000) heart failure Dynamic
Slide 9: Taking Orfadin Direct in the Americas
Taking Orfadin Direct in the Americas 2014 2014 2015 9
Slide 10: Partner Products: Strong Partnerships + Platform
Partner Products: Strong Partnerships + Platform 600 +29% 500 135 400 12 300 200 411 411 100 0 2012 2013 Base business New partnerships Co-promotion * The Base business numbers includes discontinued products of SEK 27 M for 2012 and SEK 6 M for 2013. Excluding these, the base business grew 5 per cen
Slide 11: Two Years Ago
Two Years Ago Actions to Reach Our Goals 21.60 SEK We intend to earn our way into our future based on operational performance. 1. Revenue growth through focus on key products 2. Ongoing cost discipline 3. Gross Margin improvement > Improving cash flow from operations and working capital 11
Slide 12: Results in Perspective: 2011 – 2013
Results in Perspective: 2011 – 2013 2011: Adjusted EBITA SEK -21 M 2012: Adjusted EBITA SEK 97 M • 2 500 Non-recurring SEK 78 M • Non-recurring SEK 37 M (Arexis) 1 000 (restructuring) • Co-promotion Pfizer SEK -307 M • Multiferon SEK -149 M 2 177 900 2 000 1 911 1 923 800 700 1 500 600 GM 59% M SEK
Slide 13: Q1 2014 Financial Summary
Q1 2014 Financial Summary 600 573 529 Financial Q1 2014 (Q1 2013) 500 • Total revenues: SEK 573 M (529) 400 • An increase of 8% 320 300 303 • Product revenues: SEK 406 M (345) • An increase of 18% 200 SEK M 131 135 • Gross Margin: 56% (57) 100 61 61 37 -288 • EBITA: SEK -288 M (61) 0 • EBITA excludi
Slide 14: Two Years of Progress
Two Years of Progress 76.75 SEK 14
Slide 15: Outlook 2014
Outlook 2014 Revenues MSEK 2,300 to 2,500 Gross Margin 58-60% 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 2013 Q4 report on 20 February 2014. 15
Slide 16: Building Our Future
Building Our Future 1. Diverse, growing, and profitable base business focused on rare diseases 2. First to market, long-lasting haemophilia factors will potentially enter exclusive Sobi territories in the near term (current market size is USD 3.7 Billion) 3. Pipeline of rare disease biologics 16
Slide 17: Near-Term First to Market Haemophilia Franchise
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 2012 - 2013 2014 - 2015 2016 + TIME 17
Slide 18: Haemophilia A+B Sales in Sobi Territory
Haemophilia A+B Sales in Sobi Territory SEK 24.4 B Sales in Sobi Territory 2011 21 550 SEK B 2 870 SEK B US$ 1 = SEK 6.53 (Exchange rate 2 May, 2014) 18
Slide 19: Fc Fusion Technology: Long-acting Clotting Factors
Fc Fusion Technology: Long-acting Clotting Factors • Clotting factors must be infused 2-4 times per week intravenously • Burden of therapy is a major factor influencing patient compliance and outcomes • Our long-acting factors can reduce annual injections by 50 – 75 per year • Longer-lasting clottin
Slide 20: History: Introduction of Recombinant Clotting Factors
History: Introduction of Recombinant Clotting Factors Market share % by volume, the EU Market: Recombinant Plasma Recombinant FVIII FIX 100% 100% 80% 80% 60% 60% 40% 40% 20% 20% 0% 0% 20
Slide 21: Fewer than 100 Haemophilia Reference Centres
Fewer than 100 Haemophilia Reference Centres 21
Slide 22: Expected Haemophilia Timelines
Expected Haemophilia Timelines Factor 8 Factor 9 US US Biogen Idec/Sobi Biogen Idec/Sobi FDA approval expected MY 2014 FDA approval 28 March 2014 EU EU Biogen Idec/Sobi Biogen Idec/Sobi EMA approval potentially YE 2015 EMA approval potentially H2 2016 22
Slide 23: Pipeline of Rare Disease Biologics
3 Pipeline of Rare Disease Biologics Pipeline Balancing Risk + Allocation of Capital Projects LCM with Higher investments Approved Higher earnings Products Higher risk Long-term IRR Risk Lower investments Medium earnings Year Lower risk 2013 2014 2015 2016 2017 2018 Near-term IRR Size of circle = ex
Slide 24: Pipeline of Rare Disease Biologics
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 & Kepivance Neck Cancer Hereditary Tyrosinaemia Orfadin Liquid type 1 Hereditary Tyrosinaemia Orfadin 20mg type 1 capsule Alkaptonur
Slide 25: R&D Pipeline 2014
R&D Pipeline 2014 Indication Project Partner Pre-Clin. Phase 1 Phase 2 Phase 3 Launch Hemophilia A rFVIIIFc Hemophilia B rFIXFc Oral Mucositis in Head & Kepivance Neck Cancer Hereditary Tyrosinaemia Orfadin Liquid type 1 Hereditary Tyrosinaemia Orfadin 20mg type 1 capsule Alkaptonuria Orfadin Comple
Slide 26: Kepivance Background
Kepivance Background • Kepivance (palifermin) is a recombinant human keratinocyte growth factor • Palifermin was developed to reduce the severity and duration of oral mucositis and related clinical sequelae 2013 rights to additional clinical data for Kepivance from Amgen 2008 proprietary product, ac
Slide 27: Kepivance: Current + Potential Future Indication
Kepivance: Current + Potential Future Indication Proposed Indication: Head and Neck Cancers to decrease the incidence and Current Indication: Bone Marrow Transplant duration of severe oral mucositis to decrease the incidence and in patients with unresected duration of severe oral mucositis in patien
Slide 28: Generation of Affibody C5 Inhibitors
Generation of Affibody C5 Inhibitors 2011: Lead optimization PK/PD, process feasibility, preclinical immunogenicity assessment 2010: Affinity maturation Library design, phage display selection and screening 2010: Functional characterization In vitro, in vivo, species cross reactivity 2009: Affibody
Slide 29: The Size of an Affibody-ABD Fusion Protein Is Less Than 10 per cent of an Antibody
The Size of an Affibody-ABD Fusion Protein Is Less Than 10 per cent of an Antibody Antibody 150 kDa Affibody-ABD fusion 12 kDa 29
Slide 30: Strategic Priorities
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 commercialisation of our late-stage pipeline. 3. Long-term growth will come organically and through acquisition
Slide 31: Investing in our abilities
Investing in our abilities 31
Slide 32: Investing in our people
Investing in our people (6 mo) a] x] [BB cose Pe & Empowering people: SOB! - Windows Internet Explorer eo - X Convert ~ [Select = = ie Favorites gly [J mageBank - All Pictures {@) Web Slice Gellery ¥ B) Sobi- EPiServer CMS 8) InPublic Release Publishing i th > By &~ Pager Safetyy Tooky @y ” @sobl ws
Slide 33: Key Events Calendar 2014 - 2015
Key Events Calendar 2014 - 2015* Kepivance HNC FDA meeting Fc8 US launch SOBI002 phase 1 data Fc8 paediatric data Fc8 opt-in Q2 Q3 Q4 Q1 Q2 Fc9 US launch Fc9 paediatric Orfadin direct data sales in NA * Timing for all events is indicative 33
Slide 34: Summary
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 biolo
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