Swedish Orphan Biovitrum Ab · OMXSTO:SOBI

Swedish Orphan Biovitrum Ab — Q2 2015 Earnings Presentation

23 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Jul 16, 2015

  1. Slide 1: Q2 results presentation 2015

    Q2 results presentation 2015 Geoffrey McDonough │ CEO Alan Raffensperger │ COO Mats-Olof Wallin │ CFO Stockholm | 16 July 2015

  2. Slide 2: Business summary Q2 2015

    Business summary Q2 2015 • European Commission approved Orfadin® oral suspension and 20 mg capsule • Biogen submitted the MAA for Alprolix® (rFIXFc) in Europe – subsequently validated • New haemophilia data presented with 23 abstracts at ISTH 2015 congress • Received orphan drug designation for Eloc

  3. Slide 3: Business summary Q2 2015

    Business summary Q2 2015 • Total revenues: SEK 764 M (662) 1000 • 15% growth (4% at CER) 900 • Product revenues: SEK 593 M (476) Total Revenue 800 • 25% growth (12% at CER) • ReFacto® revenues: SEK 172 (187) 700 • 8% decrease 600 500 • Gross margin 63% (61) Product Revenue 400 300 • EBITA: SEK 74 M

  4. Slide 4: Business summary H1 2015

    Business summary H1 2015 1000 • Total revenues: SEK 1 629M (1 236) • 32% growth (20% at CER) 900 Total Revenue • Product revenues: SEK 1 224 M (881) 800 • 39% growth (25% at CER) 700 • ReFacto® revenues: SEK 404 (355) 600 • 14% increase 500 Product Revenue • Gross margin 61% (59) 400 300 200 ReFacto

  5. Slide 5: YTD 2015 revenue by business line

    YTD 2015 revenue by business line Early Stage Development Programmes Haemophilia SEK 35 M USD 4 M >100%* Genetics & Inflammation SEK 369 M Metabolism +17%* +46%* SEK 445 M USD 44 M USD 53 M Partner Products SEK 376 M +9%* USD 45 M ReFacto AF SEK 404 M USD 48 M +7%* *Growth at Constant Exchange Rates

  6. Slide 6: ReFacto AF

    ReFacto AF Sales (SEK M): ReFacto • Revenue from manufacturing and 250 800 royalty SEK 172 M (187) 700 • A decrease of 8% 200 600 • Phasing effects caused by unusually high deliveries in the first quarter 2015 500 150 400 100 300 • Manufacturing revenue 200 SEK 99 M (134) 50 100 0 Q1 Q2 Q3 Q4 Q1 Q2

  7. Slide 7: Commercial Results Q2 2015

    Commercial Results Q2 2015 Alan Raffensperger │ COO

  8. Slide 8: Kineret

    Kineret® • Revenue SEK 171 M (148) Sales (SEK M): Kineret • Increase of 15% 220 800 200 700 180 • Volume growth across most 600 160 European markets 140 500 120 400 100 80 300 • US demand continues to be steady 60 200 through the shift to a patient-centric 40 100 specialty distribution model 20 0 0

  9. Slide 9: Orfadin

    Orfadin • Revenue SEK 189 M (140) Sales (SEK M): Orfadin • Increase of 35% 200 800 180 700 160 • Stable growth in major markets, 600 140 positive revenue impact from direct 120 500 sales model in the Americas 100 400 80 300 60 200 • Orfadin liquid formulation and 20 mg 40 100 capsule approved by the

  10. Slide 10: Partner Products

    Partner Products • Revenue SEK 175 M (159) Sales (SEK M): Partner Products 250 800 • Increase of 10% 700 200 600 • Increase driven by growth of 150 500 Cometriq®, Yondelis® and Xiapex® 400 100 300 200 • Concluding our launch preparations 50 100 for Xiapex for Peyronie’s disease 0 0 Q1 Q2 Q3 Q4 Q1 Q2

  11. Slide 11: Haemophilia

    Haemophilia Revenues (SEK M): Haemophilia • Estimated revenue of SEK 18 M (0) • Estimated royalty revenue from Biogen, based 20 on 2 per cent of Biogen analyst consensus from 18 10 April 2015 16 14 12 10 • Marketing Authorisation Application 8 for Alprolix submitted in June 2015 6 4 2 • Elocta appro

  12. Slide 12: Haemophilia A in Sobi territory

    Haemophilia A in Sobi territory Size of Market (M) in Sobi Territories* USD 3.3 B SEK 23 B *Source: MRB, 2011, includes all patients (mild, moderate, severe) 12

  13. Slide 13: Haemophilia Market is Concentrated

    Haemophilia Market is Concentrated Majority of Business Centred at Key Centres 13

  14. Slide 14: Dedicated launch-ready organisation with a broad experience in place

    Dedicated launch-ready organisation with a broad experience in place Commercial Medical Patient Access A strong experienced Solid team with strong Strong access team to team recruited from a clinical background and engage with patient mix of haemophilia and long experience in organizations + payers

  15. Slide 15: Expected long acting Factor VIII EU timeline

    Expected long acting Factor VIII EU timeline Anticipated start of Elocta First potential long- launch in EU (Sobi territory) acting FVIII competitors* Anticipated EC approval Elocta 18 months + 2015 2016 2017 * Based on publically announced data 15

  16. Slide 16: Financial Results Q2 2015

    Financial Results Q2 2015 Mats-Olof Wallin │ CFO

  17. Slide 17: Profit and Loss statement

    Profit and Loss statement Amounts in SEK M Q2-15 Q2-14 H1-15 H1-14 FY 2014 Total revenues 764 663 1,629 1,236 2,607 Gross profit 482 406 1,001 726 1,548 Gross Margin 63% 61% 61% 59% 59% Sales and Administration -274 -193 -493 -349 -750 Research and development -127 -133 -259 -260 -501 Other operatin

  18. Slide 18: Balance Sheet

    Balance Sheet Amounts in SEK M June 2015 June 2014 Dec 2014 ASSETS Intangible 4,128 4,241 4,248 Tangible and financial 199 161 188 Total non-current assets 4,327 4,402 4,436 Inventories 742 729 764 Accounts receivable 523 448 480 Other Receivable 194 164 172 Cash and equivalent 763 503 519 Total cur

  19. Slide 19: Net debt

    Net debt 500 50% • Cash position: SEK 763 M 400 40% • Net debt SEK 57 M 300 30% SEK M 200 20% 100 10% 0 0% Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 Q1-15 Q2-15 Net debt Net debt / Equity 19

  20. Slide 20: Summary and Outlook

    Summary and Outlook Geoffrey McDonough │ CEO

  21. Slide 21: Outlook 2015 – raised guidance

    Outlook 2015 – raised guidance Revenues Sobi expects total revenues for the full year to be in the range of SEK 3,000 to 3,200 M (previously 2,800 to 3,000) Gross Margin Gross margin is expected be in the range of 59 to 61 per cent (previously 58-60 per cent) Operating Costs Operating costs are proj

  22. Slide 22: Building our future

    Building our future Continued focus on our business and capabilities within rare diseases 1. Diverse, growing, and profitable base business in Europe and North America focused on rare diseases 2. Launching first-to-market long- acting haemophilia factors in Sobi territories – providing forward cash

  23. Slide 23: Summary

    Summary • Strong operating momentum and significant pipeline milestones in the first half year • Orfadin oral suspension and 20 mg capsule approved in Europe • Elocta launch preparations on track • Alprolix filing and opt-in in place 23

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