Swedish Orphan Biovitrum AB · OMXSTO:SOBI
Swedish Orphan Biovitrum AB — JP Morgan Conference 2013
40 slides from Swedish Orphan Biovitrum AB's conference presentation, January 2013
Slide 1: Sobi: Update and Perspective
Sobi: Update and Perspective Geoffrey McDonough, CEO JP Morgan Conference San Francisco January 2013
Slide 2: Forward Looking Statements
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 finan
Slide 3: Who We Are
Who We Are Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies that improve the lives of patients. 3
Slide 4: Quick Facts
Quick Facts • Listing: NASDAQ OMX (STO:SOBI) • Net Revenues FY 2011: $285 M - Outstanding shares: 265.2 M - Sponsored ADR through BNY Mellon (SWTUY) • EBITA1 FY 2011: $19 M • Market Cap: $1 508 M • Net Debt, September 30 2012: $42 M - Share price, close 2 January 2012: SEK 38.1 - 52-week range: SEK
Slide 5: What We Do
What We Do Our key therapeutic areas are Inflammation and Genetic diseases, with a growing focus on Hemophilia and Neonatology. We deliver products to specialist physicians and their patients through our integrated and focused team approach to sales and marketing, medical affairs and patient access.
Slide 6: Last Year at JP Morgan
Last Year at JP Morgan Actions to Reach Our Goals We intend to earn our way into our future based on operational performance. 1. Revenue growth through focus on key products 2. Ongoing cost discipline 3. Gross Margin improvement > Improving cash flow from operations and working capital 6 @sobl @sobl
Slide 7: A Diverse Commercial Portfolio + Strong Pipeline
A Diverse Commercial Portfolio + Strong Pipeline… Development US$ 4 Billion Programs Market Potential Neonatology in Pipeline Hemophilia Key Therapeutic Areas Inflammation Genetics US$ 120M +12%2 +10%2 at CER at CER +8%2 -4%2 at CER Base Partner Products ReFacto AF® US$ 150M1 Business 1) 2011 figure
Slide 8: YTD Consolidated Revenues and Net Debt
YTD Consolidated Revenues and Net Debt Merger with Swedish Orphan 300 200 0,5 250 Biovitrum 160 0,4 stand-alone 200 120 0,3 USD M USD M 150 80 0,2 100 40 0,1 50 0 0 0,0 Q3-10 Q4-10 Q1-11 Q2-11 Q3-11 Q4-11 Q1-12 Q2-12 Q3-12 2007 2008 2009 2010 2011 2012 YTD Sept Revenues EBITA before non-recurring it
Slide 9: Outlook 2012 On Track
Outlook 2012 On Track Revenues Total revenues expected to be about SEK 100 M lower than 2011, reflecting the divestment of the co-promotion rights. Gross Margin Gross margin expected to be in line with 2011 margin of 54% after adjustment for the balance sheet write-downs and the divestment of co-pro
Slide 10: Calendar Highlights 2012
Calendar Highlights 2012 Event H1 H2 2012 2012 Orfadin Liquid Formulation PIP Response Kineret CAPS PIP Response Complete Tech Transfer Kineret Manufacturing Kineret NOMID Filing FDA Top-Line Data for rFIXFc Program (BIIB) Kineret CAPS Filing EMA Top-Line Data for rFVIIIFc Program (BIIB) Kiobrina Co
Slide 11: Management Team Additions
Management Team Additions Geoffrey McDonough, Chief Executive Officer Previous positions: Genzyme Corporation since 2002, latest as President of Europe, Middle East and Africa. Alan Raffensperger, Chief Operating Officer Previous positions: CEO of Benechill Inc.,USA, Executive Director, Head of Neph
Slide 12: Twelve Months of Progress
Twelve Months of Progress Swedish Orphan Biovitrum AB (SOBI.ST) - Stockholm 38.90 ; 0.40(1.04%) Jan 4, 11:29am Est SWE ORPHAN BIOVITRU MSOBIST M “OMX +1D% +100% +0% DAs. ea 0 VALS © Yahoo! N% Mar 12 May 12 Jul 12 Sep 12 Nov 12 Jan 13 2 @sobl
Slide 13: Today's Portfolio is a Platform
Today’s Portfolio is a Platform… Development Programs Neonatology Hemophilia Key Therapeutic Areas Inflammation Genetics Base Partner Products ReFacto AF® Business 13
Slide 14: Near-Term Focus on Operating Businesses
Near-Term Focus on Operating Businesses… Pre-clinical Development Programs Hemophilia Neonatology Continued focus 1 Key Inflammation Genetics to maintain current Therapeutic momentum. Areas Partner Products Segment as 2 near-term growth driver, evolution and streamlining of business model. ReFacto B
Slide 15: Kineret – Progress
1 Kineret® – Progress • Sales of Kineret in the third quarter were 150 600 USD 17 M, an increase of 12% 4 quarters rolling revenues (SEK M) • No impact from currency y/y Quarterly revenues (SEK M) 100 400 • Priority review by FDA for application for Kineret for NOMID indication has resulted in FDA a
Slide 16: Evolving Position of Kineret in IL-1 Diseases
1 Evolving Position of Kineret in IL-1 Diseases Identifying subsets of Entering the Pediatric Emerging evidence for role RA population inflammation segment of IL-1 in disesases with Where Kineret’s short half life unmet medical need and safety profile uniquely suitable • Gout and pseudogout High Rri
Slide 17: Partner Portfolio – Growing European Platform
2 Partner Portfolio – Growing European Platform Offers small and midsized companies an integrated solution for commercialization of niche and specialty products: Emergency Oncology Medicines & • Market leader in Nordics, Baltics, CEE Antidotes • Expanding to all Europe model and Russia • Portfolio o
Slide 18: Revenues from ReFacto
3 Revenues from ReFacto • Solid volume growth in ReFacto 250 1 000 manufacturing revenues 4 quarters rolling revenues (SEK M) Quarterly revenues (SEK M) • Adjusted for validation batches in 2011 (SEK 200 800 42 M), revenues increased 3% YTD 150 600 • Higher utilization of production 100 400 facility
Slide 19: … and Mid-Term Launch of Our Pipeline
… and Mid-Term Launch of Our Pipeline Development Programs Hemophilia Neonatology Key Therapeutic Areas Inflammation Genetics Base Partner Products Business ReFacto 19
Slide 20: Hemophilia
Hemophilia Pioneer in Rare Diseases
Slide 21: Hemophilia A + B: A Combined USD $6B+ Market
Hemophilia A + B: A Combined USD $6B+ Market Global sales, 2010 ($ M) FIX BeneFIX Plasma Derived Factor (Pfizer) (Various) 1000 Source: Benefix - 2010 Pfizer Annual Report. Plasma Derived - Fall 2010 Citigroup projections. Global sales, 2010 ($ M) FVIII Advate/Recombinate Kogenate FS Helixate FS Xyn
Slide 22: Factor Use Relatively High in Sobi Territory
Factor Use Relatively High in Sobi Territory Per Capita consumption of FVIII (IU/Inhab.) Sweden ~55% of global factor sales Germany are in the Sobi territory – an Ireland Hungary approx. ~$3.4 B market France Italy USA Spain Norway Poland Switzerla… Russia Portugal Greece Czech Lithuania Bulgaria Tu
Slide 23: World Federation of Hemophilia Annual Global Survey
World Federation of Hemophilia Annual Global Survey Hemophilia Patient Segmentation ~100,000 Total Haemophilia Treated Patients Treated Patients (A&B) (A&B) 2% Immune 24% <18 years 76%> 18 years Tolerance 10% Surgery Induction approx 0,3% Elective and Emergency 60% Prophylaxis 20 % Prophylaxis Per T
Slide 24: Hemophilia Programs: Positive Top Line Data
Hemophilia Programs: Positive Top Line Data Safety Summary Factor 9: B-LONG • No inhibitors to rFIXFc were detected • No cases of anaphylaxis were reported 1. Prophylactic regimens resulted in low- • Most common adverse events (incidence of single-digit annualized bleeding rates ≥5%) occurring outsi
Slide 25: B-LONG Trial Summary
B-LONG Trial Summary Sequential PK* Nonsequential PK BeneFIX® rFIXFc rFIXFc MEDIAN ABR 2.95 Optimize Arm 1 Weekly prophylaxis regimen Up to 52 weeks Dose N=63 Weekly MEDIAN ABR 1.38 Individualized interval Optimize Arm 2 Up to 52 weeks prophylaxis regimen N=29 Interval MEDIAN ABR 17.69 Arm 3 Episodi
Slide 26: Hemophilia Programs: Positive Top Line Data
Hemophilia Programs: Positive Top Line Data Safety Summary • No inhibitors to rFVIIIFc were detected 1. Individualized and weekly prophylactic • No cases of anaphylaxis were reported regimens resulted in low-single-digit • The most common adverse events annualized bleeding rates (incidence of ≥5%) o
Slide 27: A-LONG Trial Summary
A-LONG Trial Summary Sequential PK (Advate® vs rFVIIIFc) MEDIAN ABR 1.6 Optimize Arm 1 Individualized prophylaxis ABR / Protection N=118 Surgery subgroup MEDIAN ABR 3.6 Offer Weekly Screening Arm 2 Weekly prophylaxis Option for N=24 On-Demand Randomization Surgery subgroup MEDIAN ABR 33.6 Arm 3 Epis
Slide 28: What Does Shifting the Curve Mean?
What Does Shifting the Curve Mean? ILLUSTRATION ONLY – NOT DATA 2X per week 3X per week Relative Number Of Patients 1 2 3 4 Number of Infusions Per Week 28
Slide 29: Launch in Sobi Territories will follow US
Launch in Sobi Territories will 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 29
Slide 30: Kiobrina
Kiobrina @sSObI in Rare Diseases
Slide 31: Kiobrina – Oral ERT for Premature Infants
Kiobrina – Oral ERT for Premature Infants Kiobrina is a recombinant human lipase (BSSL) given together with formula or pasteurized milk to pre-term infants, in development: • To increase growth rate • To reduce length of stay in the NICU, • To improve long-term development outcomes. 31
Slide 32: Kiobrina – Physiology
Kiobrina – Physiology 1. Bile Salt Stimulated Lipase (BSSL) is needed in the infant GI tract to digest long chain fatty acids (LCFA) 2. BSSL naturally occurs in mother’s milk 3. Premature infants do not produce BSSL a. Lack of BSSL is correlated with slower growth in neonatal period 4. BSSL not pres
Slide 33: Phase II: Potentially Significant Clinical Value
Phase II: Potentially Significant Clinical Value Growth model for a 1kg pre-term infant to reach 1.8kg 18 Growth Velocity ( g/kg/d) 16.9* 16 14 13.9 7 days * p<0.001 12 Placebo Kiobrina + (Formula /pasteurized milk) Formula/pasteurized milk The phase II Kiobrina program was designed as two parallel
Slide 34: Phase III Pivotal Trial Underway in Europe
Phase III Pivotal Trial Underway in Europe • Ongoing Phase III study primary endpoint is Growth Velocity after four weeks treatment • 12 months total observation period • A 24 month extension study has been initiated to capture longer term development outcomes * Design and timeline to be finalized.
Slide 35: Cross-Sectional Data: Growth Velocity & Risk of Impairment
Cross-Sectional Data: Growth Velocity & 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 V
Slide 36: 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 37: Strategic Priorities
Strategic Priorities 1. Near term focus on growth in key therapeutic areas, with sustainable positive cash flow from operations. 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 the
Slide 38: Reference
Reference @sobl
Slide 39: Orfadin – On Track Year to Date
Orfadin® – On Track Year to Date 100 400 • Sales of Orfadin in the third quarter 4 quarters rolling revenues (SEK M) were USD 12 M, an increase of 3% Quarterly revenues (SEK M) 75 300 • Adjusted for currency: • Revenues increased by 6% y/y • Revenues increased by 10% YTD 50 200 • North America and C
Slide 40: 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 17