Swedish Orphan Biovitrum Ab · OMXSTO:SOBI

Swedish Orphan Biovitrum Ab — Q4 2016 Earnings Presentation

34 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Feb 16, 2017

  1. Slide 1: Q4 and FY results presentation 2016

    Geoffrey McDonough | CEO Alan Raffensperger | COO Mats-Olof Wallin | CFO 16 February 2017 Q4 and FY results presentation 2016

  2. 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

  3. Slide 3: Business highlights Q4 2016

    Business highlights Q4 2016 • European commission approved marketing authorisation for Alprolix® to Sobi • European Commission granted SOBI003 orphan designation for the treatment of MPS IIIA • European study of real-life haemophilia treatment emphasises need to improve standard of care • Data reinf

  4. Slide 4: Significant events after the reporting period

    Significant events after the reporting period • First patients enrolled in A-SURE, a • Health Canada approved Orfadin® 24 month study evaluating real- capsules for the treatment of world effectiveness of Elocta hereditary tyrosinaemia type-1 • Sobi and Bioverativ revealed new (HT-1) long-term safety

  5. Slide 5: Financial highlights Q4 2016

    Financial highlights Q4 2016 • Total revenue: SEK 1,292 M (814)  59% growth (54% at CER) • Product revenue: SEK 1,144 M (698)  64% growth (58% at CER) • ReFacto revenue: SEK 148 M (116) • Gross margin: 67% (64%) • EBITA: SEK 210 (90) • Cash flow operations: SEK 26 M (13) 5

  6. Slide 6: Financial highlights FY 2016

    Financial highlights FY 2016 1 600 • Total revenue: SEK 5,204 M (3,228) 1 400  61% growth Total revenue • Product revenue: SEK 4,548 M (2,568) 1 200  77% growth 1 000 • ReFacto revenue: SEK 656 M (660) Product revenue 800 • Gross margin: 70% (62%) 600 • EBITA: SEK 1,543 M (433) 400 ReFacto revenue

  7. Slide 7: Financial highlights FY 2016 excluding one-time credits

    Financial highlights FY 2016 [excluding one-time credits of SEK 708 M] 1 400 Total revenue • Total revenue: SEK 4,496 M (3,228) 1 200  39% growth • Product revenue: SEK 3,840 M (2,568) 1 000  50% growth (49% at CER) Product revenue 800 • ReFacto revenue: SEK 656 M (660) • Gross margin: 66% (62%) 6

  8. Slide 8: Revenues by business line FY 2016

    Revenues by business line FY 2016 SEK 770 M SEK 1,106 M SEK 1,852 M SEK 820 M SEKUSD 77090 MM SEK 1,106 USD 129M M SEK USD1,852 M 216 M SEK 820 USD M 96 M USD -3%* 90 M USD+22%* 129 M USD 216 M >100%* USD 96 M 6%* -3%* +22%* >100%* 6%* SEK 656 M, USD 77 M SEK 656 M, USD 77 M -1%* -1%* *Growth at Con

  9. Slide 9: ReFacto

    ReFacto • Q4 Revenue for manufacturing and royalty SEK 148 M (116) Revenues (SEK M): ReFacto  increase of 28% 250 1 000 200 800 • Q4 Manufacturing revenue SEK 145 M (89) 150 600 100 400 • Q4 Royalty revenue SEK 3 M (27) 50 200  US royalty expires January 2018 0 0  ROW royalty expired May 2016 Q1

  10. Slide 10: Commercial results Q4 & FY 2016

    Commercial results Q4 & FY 2016 Alan Raffensperger │ COO

  11. Slide 11: Kineret

    Kineret • Q4 Revenue SEK 266 M (222)  Increase of 20% Revenues (SEK M): Kineret • FY revenue SEK 1,001 M (805) 300 1 200  Increase of 24% 250 1 000 200 800 • US distribution model and patient 150 600 support programme is driving growth 100 400 50 200 • Clinical programmes on track 0 0  First pati

  12. Slide 12: Orfadin

    Orfadin • Q4 Revenue SEK 197 M (227)  Decrease of 13% Revenues (SEK M): Orfadin • FY revenue SEK 770 M (796) 250 1,000  Decrease of 3% 200 800 • North America 150 600  Performance in the US supported by 100 400 20 mg and oral suspension launches 50 200  Orfadin approved in Canada  Revenue in Ca

  13. Slide 13: Partner Products

    Partner Products • Q4 Revenue SEK 203 M (193)  Increase of 5% Revenues (SEK M): Partner Products • FY revenues SEK 820 M (771) 250 1 000  Increase of 6% 200 800 150 600 • Revenue growth supported by new partnership with PharmaSwiss and 100 400 Xiapex 50 200 • We are in discussions regarding a 0 0

  14. Slide 14: Haemophilia – Biogen Sales

    Haemophilia – Biogen Sales Alprolix - Biogen Sales (million US$) Eloctate - Biogen Sales (million US$) 140 140 126 120 120 110 110 96 99 100 100 87 80 74 80 72 65 67 63 59 60 60 60 53 49 41 40 37 40 37 25 23 20 22 22 17 19 20 20 14 10 11 10 9 5 7 5 4 2 2 4 0 0 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

  15. Slide 15: Haemophilia

    Haemophilia Royalty and Sales Revenues (SEK M): Haemophilia * • Q4 Revenue of SEK 451 M (32) 500  SEK 174 M (2) in sales 400  SEK 277 M (30) in royalty revenue 300 • FY revenue of SEK 1,853 M (96) 200  SEK 327 M (2) in sales 100  SEK 803 M (95) in royalty revenue  SEK 708 M in one-time credits

  16. Slide 16: Redefining protection in Haemophilia

    Redefining protection in Haemophilia Adapted from Oldenburg J. Blood 2015.1

  17. Slide 17: Elocta

    Elocta Royalty and Sales Revenues (SEK M): Elocta * • Q4 Revenue SEK 304 M (18) 400  SEK 135 M (1) in sales  SEK 169 M (18) in royalty revenue 300 200 • FY revenue of SEK 1,139 M (55)  SEK 267 M (1) in sales 100  SEK 550 M (55) in royalty revenue  One-time credit of SEK 322 M 0 Q3 Q4 Q1 Q2 Q3 Q

  18. Slide 18: Elocta access update

    Elocta access update - End of December 2016 Reimbursement granted – treatment available Pricing & reimbursement decision-making in process FI NO SE DK IE NL UK PO BE DE CZ SK AT HU FR CH SL RO IT BG ES PT Algeria Kuwait Saudi Arabia UAE 18

  19. Slide 19: Alprolix

    Alprolix Royalty and Sales Revenues (SEK M): Alprolix * • Q4 Revenue SEK 147 M (13) 200  SEK 39 M (1) in sales  SEK 108 M (12) in royalty revenue • FY revenue of SEK 713 M (41) 100  SEK 60 M (1) in sales  SEK 253 M (40) in royalty revenue  SEK 14 M in milestone revenue 0  One-time credit of SE

  20. Slide 20: Alprolix access update - End of December 2016

    Alprolix access update - End of December 2016 Reimbursement granted – treatment available Pricing & reimbursement decision-making in process FI NO SE DK IE NL UK BE DE CZ SK AT FR CH SL RO IT BG ES PT Algeria UAE 20

  21. Slide 21: Financial results Q4 and FY 2016

    Financial results Q4 and FY 2016 Mats-Olof Wallin│ CFO

  22. Slide 22: Profit and loss statement

    Profit and loss statement Amounts in SEK M Q4-16 Q4-15 FY 2016 FY 2015 Total revenues 1,292 814 5,204 3,228 Gross profit 860 520 3,651 2,007 Gross Margin 67% 64% 70% 62% Sales and Administration -399 -293 -1,366 -1,058 Research and development -258 -135 -778 -513 Other operating revenues/expenses 7

  23. Slide 23: Balance sheet

    Balance sheet Amounts in SEK M Dec 2016 Sep 2016 Dec 2015 ASSETS Intangible 6,806 6,893 5,787 Tangible and other 257 257 212 Total non-current assets 7,063 7,151 5,999 Inventories 870 798 776 Accounts receivable 769 628 451 Other Receivable 487 398 185 Cash and equivalent 786 824 904 Total current a

  24. Slide 24: Outlook 2016

    Outlook 2016* All elements exceeded or met Revenues Revenues for the full year were SEK 5,204 M, above the predicted range of SEK 5,125 to 5,200 M Gross margin Gross margin for the full year was 70 per cent, according what was predicted EBITA EBITA for the full year was SEK 1,543 M above the predict

  25. Slide 25: Summary results 2016

    Summary results 2016 With and without one-time credits of SEK 708 M Revenues Revenues SEK 5,204 M SEK 4,497 M Gross margin Gross margin 70 per cent 65 per cent EBITA EBITA SEK 1,543 M SEK 836 M 25

  26. Slide 26: Summary and outlook

    Summary and outlook Geoffrey McDonough│ CEO 26

  27. Slide 27: Outlook 2017

    Outlook 2017* Revenues Sobi expects total revenues for the full year to be in the range of SEK 5,800 to 6,000 M Gross margin Gross margin is expected to be in the range of 66 to 68 per cent EBITA Sobi expects EBITA for the full year to be in the range of SEK 1,600 to 1,700 M *At current exchange rat

  28. Slide 28: Building our future

    Building our future Strong 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 territory* 3. Growing the business organ

  29. Slide 29: R&D pipeline

    R&D pipeline Therapeutic area/Indication Product/ Pre-clinical Phase 1 Phase 2 Phase 3 Project Haemophilia A Elocta/A-SPIRE* Haemophilia A Elocta/PUP1* Haemophilia B Alprolix/B-YOND* Haemophilia B Alprolix/PUP1* Acute gout Kineret/anaGO Still’s disease Kineret/anaSTILLS Alkaptonuria Orfadin/SONIA2 M

  30. Slide 30: SOBI003 for MPS IIIA

    SOBI003 for MPS IIIA - Systemic ERT with CNS penetration • MPS IIIA is a Lysosomal Storage 125 Placebo Untreated Disease – heparan sulfate (% vs. Placebo) 100 Relative levels accumulates and causes significant CNS morbidity and mortality 75 50 • SOBI003 is a recombinant human Healthy sulfamidase enz

  31. Slide 31: Sobi and Bioverativ to investigate Elocta for Immune Tolerance Induction in 2017

    Sobi and Bioverativ to investigate Elocta for Immune Tolerance Induction in 2017 ‘First ITI attempt’ Study ‘Rescue ITI’ Study Objective: To investigate rFVIIIFc for Objective : To investigate rFVIIIFc for ITI in patients with severe haemophilia ITI in patients with severe A with inhibitors undergoin

  32. Slide 32: Bioverativ to advance BIVV 001 in H2 2017

    Bioverativ to advance BIVV 001 in H2 2017 • Programme to advance to clinic in H2 2017 • Bioverativ development programme • Sobi has opt-in right at European filing • Financial terms similar to those for Elocta and Alprolix 32

  33. Slide 33: External pipeline development

    External pipeline development  expertise in biologics - engineering, process development and manufacturing  experienced in commercialization for rare disease products  a strong portfolio in  Genetic and Metabolic disease  Inflammation  Haemophilia  launch capacity in North America today, in E

  34. Slide 34: Pioneer in Rare Diseases

    @SODI Pioneer in Rare Diseases 34

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