Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Jefferies Global Healthcare Conference 2012
34 slides from Swedish Orphan Biovitrum Ab's conference presentation, Jun 5, 2012
Slide 1: Jefferies Global Healthcare Conference
Swedish Orphan Biovitrum Jefferies Global Healthcare Conference New York, 5 June 2012 Geoffrey McDonough CEO
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 commercial stage bio-pharmaceutical company with a leading position in niche and rare disease therapies. Our operations are driven by a diversified, profitable, growth-oriented product portfolio. We have a late-stage pipeline with substantial commercial potential. We
Slide 4: Quick Facts
Quick Facts • Listing: NASDAQ OMX (STO:SOBI) • Net Revenues 2011: $265 M - Outstanding shares: 265.2 M - Sponsored ADR through BNY Mellon (SWTUY) • EBITA1 2011: $17.6 M • Market Cap: $835 M • Net Debt, March 31, 2012: $24.7 M - Share price, close 1 June 2012: SEK 22.8 - 52-week range: SEK 11.40 – 26
Slide 5: Revenues by Business Lines 2011
Revenues by Business Lines 2011 Development US$ 4 Billion Kiobrina Market Potential Programs Hemophilia in Pipeline Core Products Growth $ 112 M Platforms GM ~60% Partner Products ReFacto AF® Base $ 73 M $ 80 M Business GM <50% GM >60% *Figures restated in US dollars @ SEK 7.2234/dollar 5
Slide 6: Current Operating Business
Current Operating Business Growth Platform Base Business Core Products Partner Products ReFacto AF® Inflammation Specialty Indications • Manufacturing • Kineret • Kepivance • Royalty • Ruconest • Yondelis • Ferriprox Genetics + Metabolism • Betapred • Orfadin • Buronil • Ammonaps • Aloxi • Ammonul •
Slide 7: Core Products - Kineret
Core Products - Kineret® • Biological inhibitor of IL-1 Receptor FY 2011 • Unique mechanism of action Sales +8% @ CER 20 80 High risk RA-patients with co-morbidities for which the short half Quarterly Revenue 15 60 Annual Revenue life and safety profile of Kineret are 10 40 uniquely suitable 5 20 Hi
Slide 8: Positioning Kineret in Rare Disease Segment
Positioning Kineret in Rare Disease Segment Prescriptions for Kineret® Systemic RA, 5% MAS, 1% Juvenile RA, 31% RA, 39% Pediatric Inflammation Segment • Sobi will file for NOMID in US and CAPS in EU in 2012 • Critical to allow us to support CAPS, 2% practice in children Other, Diabetes, 11% Gout, 5%
Slide 9: Core Products - Orfadin
Core Products - Orfadin® FY 2011 • Used for treatment of hereditary +5% @ CER tyrosinemia type 1 (HT-1) Sales - Tyrosineand toxic metabolites accumulate 15 50 - Affects about one child in 100,000 12 40 Quarterly Revenue Annual Revenue 9 30 6 20 3 10 USD, M 0 0 Q1-09 Q2-09 Q3-09 Q4-09 Q1-10 Q2-10 Q3-
Slide 10: Orfadin – New Formulation Meets Market Need
Orfadin® – New Formulation Meets Market Need Rationale 1. Enables precise dosing 2. Expands compliance 3. IP Extension (orphan status EU 2017) Status • Manufacturing scale-up underway • Clinical program underway • EMA PIP approved March 2012 • FDA discussion with FDA in 2012 17
Slide 11: Partner Products
Partner Products Sales Offers small/midsized companies an integrated 100 solution for commercialization of products +11% @ CER for current portfolio • Market leader in Nordics, Baltics 80 • Expanding to CEE and Russia • About 40 specialty pharmaceuticals 60 • Key therapeutic areas are hematology, 40
Slide 12: ReFacto – A Durable Platform
ReFacto – A Durable Platform Sales • Long-standing exclusive partnership 80 with Pfizer 60 • Global manufacturer of drug substance for ReFacto AF/ Xyntha® (hemophilia A) 40 • Revenues from product manufacturing and royalty on Pfizer’s global sales 20 • Pfizer expanding in emerging markets • Supply a
Slide 13: Our Pipeline
Our Pipeline Indication Product/Project Partner Phase I Phase II Phase III Reg Phase Hemophilia A rFVIIIFc Hemophilia B rFIXFc Prevent growth restric- Kiobrina tion in preterm infants Diuresis and seizures Bumetanide in neonates (reformulated) Life Cycle Management Indication Product/Project CAPS Ki
Slide 14: Long Acting Recombinant Factor 9 and Factor 8
Long Acting Recombinant Factor 9 and Factor 8 Life long therapy for Hemophilia B (Factor 9) and A (Factor 8) 1. Programs run by Biogen Idec 2. Pivotal data due H2 2012 3. Sobi and Biogen share economics through cross- royalty structure 4. Sobi has rights in Europe, Russia, Middle East, and North Afr
Slide 15: Hemophilia B and A Represent a Combined $6+ Billion Market
Hemophilia B and A Represent a Combined $6+ Billion Market With Tremendous Potential for Differentiated Products Global Sales 2010 ($M) FIX BeneFIX Plasma Derived Factor (Pfizer) (Various) 1000 Source: Benefix - 2010 Pfizer Annual Report. Plasma Derived - Fall 2010 Citigroup projections. Global Sale
Slide 16: Longer Lasting Agents Most Desired Improvement
Longer Lasting Agents Most Desired Improvement Hemophilia B Unmet Needs FIX Hemophilia A Unmet Needs FVIII Source: Market research. N=92 B-LONG only 16
Slide 17: Hemophilia is a $3.4B Market in Sobi Territory
Hemophilia is a $3.4B Market in Sobi Territory Hemophilia B FIX • Europe $380M • 44% of global sales • ~ 4,000 patients Hemophilia A • Europe $3B FVIII • 55% of global sales • ~ 22,000 patients B-LONG only 17
Slide 18: Factor Use for Prophylaxis High in Sobi Territory
Factor Use for Prophylaxis High in Sobi Territory Per Capita consumption of FVIII (IU/Inhab.) Sweden Germany Ireland Hungary France Italy USA Spain Norway Poland Switzerla… Russia Portugal Greece Czech Lithuania Bulgaria Turkey Romania 0 2 4 6 8 10 Source: WFH 2009 18
Slide 19: 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 20: Fc Fusion Technology Well Understood
Fc Fusion Technology Well Understood rFIXFc rFIXFc Model of Enbrel® (etanercept) rFIXFc Orencia® (abatacept) Nplate® (romiplostim) Arcalyst® (rilonacept) Amevive® (alefacept) rFVIIIFc Model of rFVIIIFc 1Summary of product characteristics of BeneFIX® (Nov 18, 2009) 2 Blood 2011 blood-2011-07-367003;
Slide 21: Phase II Studies Confirm Long Half-Life
Phase II Studies Confirm Long Half-Life • ~3 x increase in half-life relative to historical data for BeneFIX® rFIXFc rFIXFc PK parameter Elimination T½ (hours)2 Model of rFIXFc n=11 mean 57 h (42–75 h) rFIXFc BeneFIX®1 n=56 mean 19 h (11–36 h) • ~1,5-1,75 fold increase in half-life versus Advate® •
Slide 22: Pivotal Studies To Assess Prophylaxis + On Demand
Pivotal Studies To Assess Prophylaxis + On Demand B-LONG • An Open-Label, Multicenter study rFIXFc • Evaluation of Safety, Pharmacokinetics and Efficacy in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B A-LONG • An Open-Label, Multicenter Study • Eva
Slide 23: Program Timelines: Sobi Territories Follow US
Program Timelines: Sobi Territories Follow US 2010 2011 2012 2013 2014 2016 rFIXFc B-LONG H1 H2 Data Start of Read Phase III Out studies Start of Pediatric Launch studies H1 in Sobi Territory rFVIIIFc A-LONG H1 H2 Data Start of Read Phase III Out studies Start of Pediatric studies H1 B-LONG only 23
Slide 24: Kiobrina – Oral Enzyme Replacement for Premature Infants
Kiobrina – Oral Enzyme Replacement for Premature Infants • Kiobrina is recombinant human Bile Salt Stimulated Lipase (rhBSSL) given together with formula or pasteurized milk to restore BSSL activity in the infant GI tract and to support growth in the neonatal period 1. BSSL needed in the infant GI t
Slide 25: Aim to Improve Growth
Aim to Improve Growth Reduce NICU Costs + Improve Development Outcomes • Earlier discharge • Reduced Hospital Utilization $14,000 - 28,000 Cost saved if discharged 1 week • Reduced Illness due to prolonged earlier from NICU hospitalization + • Improved functional outcomes Improved developmental • Re
Slide 26: 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 27: Phase II: Potentially Significant Medical Value
Phase II: Potentially Significant Medical Value Growth velocity • Phase II data show Kiobrina accelerated g/kg/day 18 growth after one week of treatment 16.9* 16 Target growth >15 g/kg/day • Ongoing Phase III study uses same primary endpoint of Growth Velocity, 14 13.9 with four weeks treatment and
Slide 28: 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 end points: Growth velocity after 4 weeks • Follow-up period of 12months 28
Slide 29: Kiobrina Could Help >275,000 Patients Globally
Kiobrina Could Help >275,000 Patients Globally* 24,000 86,000 178,000 Latin America* Korea Filing Based on EU Dossier Australia US MENA* China Current Phase III Study Russia 20,000 US Pivotal Study EU Bridging Studies (based on EU File) *Lat AM: Brazil, Mexico, Argentina, Venezuela *MENA: Saudi, Ira
Slide 30: Leveraging Strategic Biologics Development Capabilities
Leveraging Strategic Biologics 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 Protein rFIXFc Engineering Pharmacology & CMC
Slide 31: Focus on Revenue Growth + Profitability
Focus on Revenue Growth + Profitability Merger with Swedish Orphan International Biovitrum Stand Alone USD, M USD, M % Figures restated in US dollars @ SEK 7.2234/dollar EBITA 2011 includes write-down of ~$30M 31
Slide 32: Cash Flow + Net Debt
Cash Flow + Net Debt 60.0 200 30% 40.0 150 20% $M 20.0 $M 100 0.0 10% 50 -20.0 Q4-10 Q1-11 Q2-11 Q3-11 Q4-11 Q1-12 0 0% Q3-10 Q4-10 Q1-11 Q2-11 Q3-11 Q4-11 Q1-12 Cash flow before financing (excl. acq.) Whereof working capital Net debt Net debt / Equity Figures restated in US dollars @ SEK 7.2234/dol
Slide 33: 2012 Calendar Highlights
2012 Calendar Highlights Event H1 2012 H2 2012 Orfadin Liquid Formulation PIP Response Kineret CAPS PIP Response Complete Tech Transfer Kineret Manufacturing □ Kineret NOMID Filing FDA □ Kineret CAPS Filing EMA □ Top-Line Data for rFVIIIFc + rFIXFc Programs (BIIB) □ Kiobrina Complete Phase 3 Enrollm
Slide 34: Summary
Summary Sobi is a commercial stage bio-pharmaceutical company with a leading position in rare diseases. 1. Diversified, profitable, growth-oriented product portfolio. 2. Late-stage pipeline with substantial commercial potential. Pioneer & Partner in Rare Diseases 3. World-class capabilities in prote
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