Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — JP Morgan Healthcare Conference 2012
39 slides from Swedish Orphan Biovitrum Ab's conference presentation, Jan 10, 2012
Slide 1: JP Morgan Healthcare Conference
JP Morgan Healthcare Conference San Francisco, 10 January 2012
Slide 2: Safe Harbor Disclaimer
Safe Harbor Disclaimer 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
Slide 3: Who We Are
Who We Are Sobi is an innovative bio‐pharmaceutical company with a leading position in the commercialization of niche and rare disease products. Our operations are driven by a diversified and growth‐oriented portfolio in niche and rare disease therapies. We have a late‐stage pipeline with substantia
Slide 4: Our Vision
Our Vision Sobi is recognized as the leading integrated bio‐pharmaceutical company … dedicated to bringing innovative therapies and services … to improve the health of rare disease patients and their families. 4
Slide 5: Actions to Reach Our Goals
Actions to Reach Our Goals 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 5
Slide 6: Diversified Base, European + Growing US Presence
Diversified Base, European + Growing US Presence • Traded on NASDAQ OMX: (STO:SOBI) • Sponsored ADR available through BNY Mellon • Market Capitalization1: USD 585 M • Net Revenues2: USD 271 M • Employees: ~ 500 Sales by Revenue Type Product Sales and Co‐promotion by Region Co‐promotion 5% Rest of Wo
Slide 7: Our Future Built Upon Growing Base Operations
Our Future Built Upon Growing Base Operations Development Programs Kiobrina Hemophilia Inflammation Core Products Genetics + USD 116 M Metabolism Growth 6% Three GM ~60% Business Lines ReFacto AF® Specialty Distribution Growth USD 88 M Portfolio Platforms Growth 34% USD 67 M GM>60% Growth 8% GM<50%
Slide 8: ReFacto AF® - A Durable Platform
ReFacto AF® ‐ A Durable Platform Sales (USD M): ReFacto AF ® • Partnership with Pfizer 140 • Global sales 2010: USD 404 M 120 100 • As the exclusive supplier, we have: 80 • Made ReFacto AF® (albumin free) 60 • Substantially increased capacity 40 • Enabled expansion of Pfizer’s business 20 0 • 2011 a
Slide 9: Specialty Distribution Portfolio – Regional Leadership + Diversified Growth
Specialty Distribution Portfolio – Regional Leadership + Diversified Growth • Preferred partner for rare disease commercialization • Rare Disease and Specialty Hematology/Oncology and Portfolio ReFacto® Co‐promotion • Create focus on the right deals Other USD 13 M 1. Therapeutic Area overlap USD 27
Slide 10: Core Products – Proprietary Strategic Growth Drivers
Core Products – Proprietary Strategic Growth Drivers 1. Niche Therapeutic Areas Ammonaps® Ruconest® • Genetics + Metabolism and Ammonul® • Inflammation USD 0.1 M USD 10 M 2. Focus for Growth • Room to expand in existing markets • Focus on growth in key markets Kineret® (US, Russia, Middle East) Orfa
Slide 11: Core Products – Proprietary Strategic Growth Drivers
Core Products – Proprietary Strategic Growth Drivers Ammonaps® Ruconest® and Ammonul® Real USD 0.1 M Develop USD 10 M World Outcomes Innovative Therapies Orfadin® Kineret® USD 60 M VALUE USD 46 M Drive Efficient Win Operations Durable Market Access 11
Slide 12: Kineret® – Repositioning is Creating Growth
Kineret® – Repositioning is Creating Growth • We acquired Kineret® in 2008 • We identified a niche where Kineret Sales (USD M): Kineret addresses a significant medical need: 20 80 High risk RA‐patients with 15 60 co‐morbidities for which the short half life and safety profile of Kineret are 10 40 un
Slide 13: Key Success Factor: Kineret® Tech Transfer Delivery
Key Success Factor: Kineret® Tech Transfer Delivery • Sobi is transferring manufacturing for Kineret® to a CMO in Europe • Sobi purchased 90M USD in Kineret® inventory from Amgen 2010 to support tech transfer • Tech transfer has been delayed with additional costs in 2011 + 2012 • Process Validation
Slide 14: Kineret® – Strong Interest in Broader Inflammation
Kineret® – Strong Interest in Broader Inflammation Prescriptions for Kineret® Unspecified Other, 1% inflammation, 5% Gout, 5% Diabetes, RA, 11% 39% CAPS, 2% Pediatric Inflammation Juvenile • Sobi will file within CAPS in US and RA, 31% EU in 2012 Pediatric • Critical to allow us to support clinical
Slide 15: Orfadin® – Understanding the Growth Drivers
Orfadin® – Understanding the Growth Drivers 1. Addressing Clinical Needs in Adolescents Sales (USD M): Orfadin • Support Adequate Dosing 15 60 • Compliance 10 40 2. Monitoring • Substrate and drug levels 5 20 3. Newborn Screening 0 0 • Gaining ground in US and Europe 2009 2010 2011 Quarterly 4 quart
Slide 16: Orfadin® – Active Life Cycle Management
Orfadin® – Active Life Cycle Management Liquid Formulation • Drug Candidate available • Manufacturing scale‐up underway EMA • Pediatric Investigation Plan submitted May 2011 • PIP approval could come in 2012 • May extend orphan status in Europe until 2017 FDA • Discussion with FDA in 2012 16
Slide 17: Focus on Cost Discipline
Focus on Cost Discipline Operating Expenses Have 1. HQ personnel reduced by Decreased from 55% to 49% of Revenue 40 FTEs in 2010 180 2. R&D restructuring 60 FTEs by 160 year end 2011 140 3. Two buildings to be closed in 120 Q1 2012 USD M 100 80 4. Focus on late stage development and 60 de‐risking of
Slide 18: Focus on Delivery
Focus on Delivery Operational Organic Pipeline Performance Growth Delivery 18
Slide 19: Increasing R+D Leverage: Phase 3 + Commercial
Increasing R+D Leverage: Phase 3 + Commercial 100 Late Stage Protein Develop‐ 80 ment 60 USD M Clinical Develop‐ 40 ment 20 Commercial portfolio 0 2008 2009 2010 2011 Product support Clinical Development LCM Pre‐clinical Development Long acting Factors Discovery Note: 2008 only Biovitrum pre acquisi
Slide 20: Sobi has Retained Strategic Development Capabilities
Sobi has Retained Strategic Development Capabilities Value creation for innovative biologics Syntonix Arexis therapies through: rFIXFc BSSL 1. Protein biochemistry capabilities in late preclinical development 2. GMP biologics process develop‐ ment and manufacturing scale‐up Protein rFIXFc Engineerin
Slide 21: Kiobrina – Enzyme Replacement for Premature Infants
Kiobrina – Enzyme Replacement for Premature Infants • Bile Salt Stimulated Lipase (BSSL) naturally occurs in mother’s milk • Infants do not produce BSSL • BSSL not present in pasteurized milk or formula • BSSL is important for growth and absorption of fatty acids, critical for brain development • La
Slide 22: Potentially Significant Medical Value
Potentially Significant Medical Value • In the US approximately 24,000 infants born <32 weeks would be eligible for Kiobrina therapy • Restoring growth in premature infants may reduce morbidy + NICU stay, and improve development outcomes • Phase II data show Kiobrina accelerated 18 growth after one
Slide 23: Growth Velocity Correlated With Risk of Impairment
Growth Velocity Correlated With Risk of Impairment % Patients w/ Impaired Neurodevelopment % Patients w/ Cerebral Palsy 60 25 50 20 40 15 30 10 20 10 5 0 0 12 g*kgˉ¹*dˉ¹ 16 g*kgˉ¹*dˉ¹ 18 g*kgˉ¹*dˉ¹ 21 g*kgˉ¹*dˉ¹ 12 g*kgˉ¹*dˉ¹ 16 g*kgˉ¹*dˉ¹ 18 g*kgˉ¹*dˉ¹ 21 g*kgˉ¹*dˉ¹ Growth Velocity Growth Velocity
Slide 24: SPA-Approved Pivotal Trial Underway in Europe
SPA‐Approved Pivotal Trial Underway in Europe 2008 2009 2010 2011 2012 2013 PIP Phase III Europe (n=432) Phase II development Phase III US • First patient enrolled in July 2011 • Last patient out expected Q4 2013 • Primary EP: GV at 4 wks, 12mo obs Target indication: Enzyme replacement therapy to re
Slide 25: Based on ongoing phase III study in Europe, Sobi can access >275,000 patients
Based on ongoing phase III study in Europe, Sobi can access >275,000 patients globally* 24,000 95,000 160,000 Latin America* Korea Filing based on EU dossier Australia Japan US MENA* China Current phase III study Russia US Pivotal Study EU Bridging Studies (based on EU File) *Lat AM: Brazil, Mexico,
Slide 26: Improved growth will reduce the costs of treatment
Improved growth will reduce the costs of treatment • Earlier discharge • Reduced Hospital Utilization E.g. cost saved if discharged 1 week earlier from NICU • Reduced Illness due to prolonged 14,000‐28,000 USD hospitalization + • Improved functional outcomes Benefit – health outcomes and • Reduced r
Slide 27: Global Proprietary Innovation in Neonatology
Global Proprietary Innovation in Neonatology Pioneers in neonatology • Potentially significant medical value • Our own product • Global potential Neonatology is attractive • Low competition • Able to support innovation • Addressable audience 2015 27
Slide 28: Hemophilia A and Hemophilia B: Lifelong IV Therapy
Hemophilia A and Hemophilia B: Lifelong IV Therapy 28 28
Slide 29: Hemophilia: Demonstrates Potential of Biologics Expertise
Hemophilia: Demonstrates Potential of Biologics Expertise 2007 BVT/Biogen Idec 2016 Partnership Commercialization in Sobi Territories 2006 BVT/Syntonix Collaboration Initiated 2010 Kabi, Sobi/Biogen Idec 1H 2012 Pharmacia, Restructured Biovitrum FPI Pediatric Collaboration Trials Heritage in Hemophi
Slide 30: Strong Alignment with Biogen Idec to Deliver Value
Strong Alignment with Biogen Idec to Deliver Value • Potential to deliver the first long‐acting recombinant factors to the global market Sobi repays its share of development costs: 1. Milestone for each program at MAA filing 2. Cross‐Royalties 3. True‐up payment at six years 30
Slide 31: Hemophilia is a $3.4B USD Market in Sobi Territory
Hemophilia is a $3.4B USD Market in Sobi Territory Factor Consumption by Patients Hemophilia A • Europe 3B USD • 55% of global $ sales • > 50 Brands Prophylaxis • ~ 73% recombinant On Demand • ~22 000 patients on regular treatment Hemophilia B Factor Consumption by Units • Europe 380M USD • 44% of g
Slide 32: Factor Use for Prophylaxis High in Sobi Territory
Factor Use for Prophylaxis High in Sobi Territory Per Capita consumption of FVIII (IU/Inhab.) Sweden • Highly developed Centers of Excellence Germany Ireland Hungary • Early recognition of the value of France prophylaxis Italy USA • “Not accepting a bleed” Spain Norway • Strong Patient Advocacy grou
Slide 33: Significant Opportunity to Improve On-Demand Care
Significant Opportunity to Improve On‐Demand Care No. of injections given when bleedings occur. One More than injection three 30% injections 70% of EU patients 19% treated on‐demand use Two more than Three injections injections 1 injection per bleed 26% 25% Sobi – Factor VIII and vWF market study 20
Slide 34: Longer Lasting Agents Most Appealing as Improvement
Longer Lasting Agents Most Appealing as Improvement and Most Likely to Generate Switch Very high 10 9 8 High 7 6 Average 5 4 3 Low 2 1 Very low 0 Longer lasting agents Subcutaneous administration Lower price Better dose adjustment of vials Importance Likelihood propose switch Sobi Hemophilia Care‐20
Slide 35: Phase Two Studies Confirm Long Half-Life
Phase Two Studies Confirm Long Half‐Life Phase I/II Trial: rFIXFc PK parameter Elimination T½ (hours)2 rFIXFc n=11 mean 57 h (42–75 h) Model of BeneFIX®1 n=56 mean 19 h (11–36 h) rFIXFc • ~3 x increase in half‐life relative to historical data for BeneFIX® Phase I/II Trial: rFVIIIFc PK parameter Elim
Slide 36: Pivotal Studies To Assess Prophylaxis + On Demand
Pivotal Studies To Assess Prophylaxis + On Demand B‐LONG: An Open‐Label, Multicenter study • Evaluation of the Safety, Pharmacokinetics and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B A‐LONG An Open‐Label, Multicenter study •
Slide 37: Pivotal Program Timelines: Sobi Territories Follow US
Pivotal Program Timelines: Sobi Territories Follow US 2010 2011 2012 2013 2014 2016 H1 H2 rFIXFc Start of Phase III Data Read studies Out Start of Pediatric studies 1H Commercial‐ ization in Sobi H1 H2 Territory rFVIIIFc Start of Phase III Data Read studies Out Start of Pediatric studies 1H 37
Slide 38: Sobi has Significant Experience in the Market
Sobi has Significant Experience in the Market Sobi Market Share in Co‐Promotion Territory 60 50 40 MS% 30 20 10 0 Sobi Nordic Pfizer Territory ReFacto AF® MS% Advate® MS% Source: Analyst report internal analysis wholesaler data 38
Slide 39: Summary
Summary 1. Diversified commercial portfolio focused on improving cash flow and profitability 2. Working to efficiently commercialize our proprietary innovative medicines Pioneer & Partner in Rare Diseases for rare disease patients globally 3. Business model oriented to building value through partner
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