Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q3 2014 Earnings Presentation
28 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Oct 30, 2014
Slide 1: Q3 Results 2014
Q3 Results 2014 Geoffrey McDonough │ CEO Alan Raffensperger │ COO Mats-Olof Wallin │ CFO Stockholm | 30 October 2014
Slide 2: Highlights Q3 2014 – Business
Highlights Q3 2014 Business • Expanded the Haemophilia development portfolio by electing to include potentially longer-acting Haemophilia A candidate (rFVIIIFc-XTEN) in collaboration agreement with Biogen Idec. • Opened North American headquarters in Waltham, Massachusetts 2
Slide 3: Highlights Q3 2014 – Financial
Highlights Q3 2014 Financial Q3 2014 (Q3 2013) MSEK 700 666 • Total revenues: SEK 666 M (517) • An increase of 29% 600 517 • An increase of 23% at constant exchange 500 rates 395 400 • Product revenues: SEK 532 M (394) 306 • An increase of 35% 300 • Gross Margin: 59% (59) 200 175 120 • EBITA: SEK 12
Slide 4: Highlights YTD 2014
Highlights YTD 2014 Financial YTD 2014 (YTD 2013) MSEK 1,902 • Total revenues: SEK 1,902 M (1,566) 1,900 • An increase of 21% 1,566 • An increase of 18% at constant exchange 1,400 rates 1,121 926 • Product revenues: SEK 1,414 M 900 (1,110) • An increase of 27% 400 243 232 146 146 181 • Gross Margin:
Slide 5: YTD Revenue by Business Line
YTD Revenue by Business Line Early Stage Development Programmes Haemophilia SEK 19 M USD 3 M Genetics & Inflammation +12% SEK 446 M Metabolism +37% SEK 465 M USD 67 M USD 70 M Partner Products SEK 484 M +30% USD 72 M ReFacto AF® SEK 488 M USD 73 M +7% USD 1 = SEK 6.6757 (average rate for the period)
Slide 6: Revenue Trajectory: Driven by Product Sales
Revenue Trajectory: Driven by Product Sales MSEK 700 Total Revenue • Total revenue driven by double digit growth in product sales 600 500 • ReFacto continues to meet our expectations for single digit growth 400 Product Revenue 300 200 ReFacto Revenue 100 0 6
Slide 7: ReFacto AF
ReFacto AF • Revenue for manufacturing and Sales (SEK M): ReFacto royalty SEK 134 M (124) 250 800 • Increase of 8% • YTD was SEK 488 M (456) 200 600 150 • Manufacturing revenue 400 SEK 92 M (84) 100 200 50 • Royalty revenue SEK 42 M (39) 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2012 2013 2014 Manufactur
Slide 8: Results Q3 2014
Results Q3 2014 Alan Raffensperger │ COO Stockholm | 30 October 2014
Slide 9: Kineret
Kineret® Sales (SEK M): Kineret • Revenue SEK 174.1 M (141.8) 200 700 • increase of 23% 180 • YTD was SEK 446.0 M (398.2) 600 160 140 500 • US volumes have recovered after 120 400 lower volumes in the first quarter 100 300 80 60 200 • Volumes continue to grow in Europe 40 100 20 0 0 Q1 Q2 Q3 Q4 Q1 Q
Slide 10: Orfadin
Orfadin® Sales (SEK M): Orfadin • Revenue SEK 163.5 M (81.9) 180 500 • YTD was SEK 379.3 M (274.7) 160 450 400 140 • First full quarter impact from direct 350 120 sales in North America 300 100 250 80 200 • Volume growth in the Middle East, 60 150 North Africa and Russia 40 100 20 50 0 0 Q1 Q2 Q3 Q4
Slide 11: Partner Products
Partner Products Sales (SEK M): Partner Products • Revenue SEK 160 M (147) 200 Sales (MSEK): Partner Products 700 • increase of 9% 180 • YTD was SEK 484 M (373) 600 160 140 500 • Good growth across the base 120 400 portfolio 100 300 80 60 200 • First sales of ChondroCelect recorded 40 in the quarter
Slide 12: Partner Products Annual Growth Trend
Partner Products Annual Growth Trend • Significant turnaround over past MSEK Revenue three years 600 546 500 484 • Driven by a combination of portfolio 407 growth and new deals 400 300 • We will continue to expect 2 – 3 200 transactions per year on this platform 100 0 2012 2013 YTD 2014 Excluding co
Slide 13: Financials Q3 2014
Financials Q3 2014 Mats-Olof Wallin │ CFO Stockholm | 30 October 2014
Slide 14: Profit and Loss Statement
Profit and Loss Statement Jan-Sep Jan-Sep Amounts in SEK M Q3-14 Q3-13 2014 2013 Total revenues 666 517 1,902 1,566 Cogs -271 -211 -781 -640 Gross profit 395 306 1,121 926 Gross Margin 59% 59% 59% 59% Sales and Administration -187 -150 -536 -429 Research and development -91 -113 -351 -353 Other oper
Slide 15: Balance Sheet
Balance Sheet Amounts in SEK M Sept 2014 Sept 2013 Dec 2013 ASSETS Intangible 4,231 4,701 4,637 Tangible and financial 183 148 152 Total non-current assets 4,414 4,849 4,789 Inventories 726 693 726 Accounts receivable 451 370 415 Other Receivable 169 144 145 Cash and equivalent 611 449 445 Total cur
Slide 16: Net Debt
Net Debt 500 50% • End of quarter cash position: SEK 611 M 400 40% • Net debt SEK 206 M 300 30% • Expected one-time cost in Q4 for SEK M Multiferon® 200 20% • SEK 25 to 30 M, with limited cash impact 100 10% • Expected larger payments in Q4 • XTEN payment Q4, USD 7M 0 0% • Potential Elocta opt-in Q4
Slide 17: Summary and Outlook
Summary and Outlook Geoffrey McDonough │ CEO Stockholm | 30 October 2014
Slide 18: Outlook 2014 (Unchanged)
Outlook 2014 (Unchanged) 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. 18
Slide 19: Significant events after the reporting period
Significant events after the reporting period • Biogen Idec filed a marketing authorisation application for Elocta™ in Europe • Decided to discontinue the production of Multiferon • Placed the phase 1 study of SOBI002 on clinical hold • Decided not to pursue an additional indication for Kepivance® 1
Slide 20: Building Our Future
Building Our Future 1. Diverse, growing, and profitable base business focused on rare diseases 2. Near-term first-to-market long- acting haemophilia factors with exclusive USD 3.7 B in Sobi territories 3. Pipeline of early stage rare disease biologics 20
Slide 21: Expected Elocta EU timeline
Expected Elocta EU timeline EU MAA filing Sobi opt-in Possible EMA approval Elocta launch in EU (Sobi territory) Sobi 2014 2015 2016 2017 2018 21
Slide 22: Sobi/Biogen Collaboration Financial Flows for Eloctate/Elocta Programme
Sobi/Biogen Collaboration Financial Flows for Eloctate/Elocta Programme BIIB first commercial sale EMA approval Contractual Milestones EMA filing/ Sobi first After Sobi’s share Sobi Opt-in commercial sale of development cost is paid back Sobi royalty to BIIB 17% Base rate Royalties 12% cross royalty
Slide 23: Haemophilia A in Sobi Territory
Haemophilia A in Sobi Territory Size of Market (M) in Sobi Territories* $ 3,3 *Source: MRB, 2011, includes all patients (mild, moderate, severe) 23
Slide 24: Haemophilia A in Sobi Territory
Haemophilia A in Sobi Territory Recombinant Market in Europe Plasma:Recombinant in European Market* 11% Baxter 17% 46% Bayer 43% Recombinant Pfizer Plasma CSL Behring 57% 26% *Source: MRB, 2011, includes all patients (mild, moderate, severe) 24
Slide 25: Expected Long Acting FVIII EU timeline
Expected Long Acting FVIII EU timeline EU MAA filing Sobi opt-in Possible EMA approval Elocta launch in EU (Sobi territory) Sobi 2014 2015 2016 2017 2018 Competitors First potential Second long-acting potential long- FVIII acting FVIII competitor* competitor* * Based on publically announced data 25
Slide 26: Sobi Launch Team on Track
Sobi Launch Team on Track Headcount • Preparation has been ongoing for 120 Anticipated EU Approval two years Elocta™ Q4 2015 100 • On track to reach launch readiness in 80 2015 with fully dedicated organization 60 • Sequential build of Market Access, 40 Medical Affairs, and Commercial teams 20 0 H2
Slide 27: Building a Leading Rare Disease Company
Building a Leading Rare Disease Company EBITA Short-term Medium- Long-term term Early Programmes Haemophilia Haemophilia royalties Genetics & Metabolism Inflammation Partner Products ReFacto 2012 - 2013 2014 - 2015 2016 + TIME 27
Slide 28: Strategic Priorities
Strategic Priorities 1. Near-term focus on growth in our base business, with sustainable positive cash flow from operations. 2. Medium-term investments to ensure successful commercialisation of our haemophilia programmes. 3. Long-term growth will come organically and through acquisitions. 28
Swedish Orphan Biovitrum (Sobi) — Q3 2014 Earnings Presentation on 6ix