Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q4 2017 Earnings Presentation
31 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Feb 22, 2018
Slide 1: Q4/FY 2017 results presentation
Guido Oelkers, CEO Mats-Olof Wallin, CFO 22 February 2018 Q4/FY 2017 results presentation
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 AB (publ) is providing the following cautionary statement. This presentation contains forward-looking statements with respect to
Slide 3: Highlights 2017
Highlights 2017 Haemophilia Specialty Care ✓ Outstanding sales growth ✓ Established in Q2 ✓ rFIXFc-XTEN added to Bioverativ ✓ Double digit growth for Kineret® and Orfadin® collaboration agreement ✓ Solid uptake for Orfadin’s new formulations – ✓ Improved joint-health for haemophilia A oral suspensio
Slide 4: Events after the reporting period
Events after the reporting period • FDA accepted investigational new drug application and granted Fast Track status for SOBI003 for the treatment of MPS IIIA • Ireland switching all people with haemophilia A & B treated with replacement clotting factors to Sobi’s extended half-life therapies 4
Slide 5: Financial highlights Q4
Financial highlights Q4 2 000 Revenue SEK 1,875 M (1,292) +45% 1 800 1 600 Gross margin 71% (67) 1 400 EBITA SEK 619 M (210) +195% 1 200 1 000 Cash flow from operations SEK 257 M (26) 800 600 400 200 0 16Q1 16Q2 16Q3 16Q4 17Q1 17Q2 17Q3 17Q4 Total revenue (SEK M) Revenue One-time credit 5
Slide 6: Financial highlights FY
Financial highlights FY 2 000 Revenue SEK 6,511 M (5,204) +25% 1 800 (+ 45 % excl. one-time credits in 2016) 1 600 Gross margin 72% (70) 1 400 1 200 EBITA SEK 2,053 M (1,543) +33% 1 000 Cash flow from operations SEK 1,333 M 800 (343) 600 400 200 0 16Q1 16Q2 16Q3 16Q4 17Q1 17Q2 17Q3 17Q4 Total revenu
Slide 7: Sales per region
Sales per region Product revenues per region1 Excluding ReFacto revenues 74% EUROPE SEK 4,393 M 20% NORTH AMERICA 1% 5% MENAR2 REST OF THE WORLD SEK 1 168 M SEK 85 M SEK 272 M 1Revenues from legal companies registered in each region, FY 2017 2Middle East, North Africa, Russia 7
Slide 8: Commercial results
Commercial results
Slide 9: Haemophilia – delivering stellar growth
Haemophilia – delivering stellar growth Q4 revenue SEK 985 M (451) Royalty and sales revenues (SEK M): Haemophilia • SEK 671 M (174) in sales revenue 1,000 • SEK 314 M (277) in royalty revenue 800 FY revenue SEK 3,088 M (1,853) 600 • SEK 1,920 M (327) in sales revenue 400 • SEK 1,168 M (1,525) in ro
Slide 10: Elocta – increasingly the standard of care
Elocta – increasingly the standard of care Sales Revenues (SEK M): Elocta Q4 sales revenue of SEK 540 M (135) 600 • SEK 123 M (29%) growth compared to Q3 2017 500 • More than 50 % of the growth derived from France and Germany 400 300 FY sales revenue SEK 1 557 M (267) 200 Launched in 22 countries 10
Slide 11: Landmark commercialisation of Elocta
Landmark commercialisation of Elocta Successful negotiations Cost effectiveness in tender markets, e.g. recognised by payers UK, RoI, Saudi Arabia Leading position Evidence generation in key markets, inhibitor patients enrolled in Fast launch e.g. France the ReITIrate study sequence beating benchmar
Slide 12: Alprolix – uptake continues strongly
Alprolix – uptake continues strongly Sales Revenues (SEK M): Alprolix Q4 sales revenue of SEK 131 M (39) 150 • SEK 34 M (34%) growth compared to Q3 2017 • More than 50% of the growth derived from 100 Germany, Ireland and the Netherlands FY sales revenue SEK 363 M (60) 50 Launched in 14 countries 0 Q
Slide 13: Haemophilia strategic imperatives – driving success
Haemophilia strategic imperatives – driving success Real-world evidence and experience supporting safety and efficacy • Established real-world safety profile in thousands of patients Provide individual choice for optimal therapeutic outcome • Elocta and Alprolix indicated for all ages, in prophylaxi
Slide 14: Significant potential for development
Significant potential for development Growth based on innovation • Fc fusion technology • Real world evidence supporting differentiating efficacy and safety • Priced to enable wide access and adoption • Extended half-life products allow reduced treatment burden Alprolix • 14 days interval • Emerging
Slide 15: Specialty Care – three core strengths
Specialty Care – three core strengths World-class commercialisation platform Lifecycle management & indication expansion Partner product portfolio with room to grow 15
Slide 16: Specialty Care – strong business platform for continued growth
Specialty Care – strong business platform for continued growth Revenues (SEK M): Specialty Care Q4 revenue SEK 761 M (692) +10% 1,000 4000 750 3000 YTD revenue SEK 2,829 M (2,695) +5% • Adjusted for discontinued products (mainly Cometriq) increase of 9% 500 2000 Double-digit growth for Kineret 250 1
Slide 17: Orfadin – double digit growth with increased generic competition
Orfadin – double digit growth with increased generic competition Revenues (SEK M): Orfadin Q4 revenue SEK 223 M (197) +13% 250 1,000 200 800 FY revenue SEK 862 M (770) +12% 150 600 Double digit growth in North America and EMENAR 100 400 • Patient insights and market understanding 50 200 • Growth in
Slide 18: Kineret – strong performance driven by patient demand
Kineret – strong performance driven by patient demand Revenues (SEK M): Kineret Q4 revenue SEK 307 M (266) +15% 400 1,600 300 1,200 YTD revenue SEK 1,142 M (1,001) +14% 200 800 Strong double digit value and volume growth in both North America 100 400 and EMENAR 0 0 • EMENAR sales were positively imp
Slide 19: Kineret – a unique mechanism of action
Kineret – a unique mechanism of action IL-1 pathway Two new clinical trials in 2017 to explore indication expansion • anaGO – acute gout • anaSTILLs – Still’s disease Anakinra, in red, bound to the interleukin 1 receptor, in grey. 19
Slide 20: ReFacto – a solid revenue base
ReFacto – a solid revenue base Revenues (SEK M): ReFacto 250 1,000 Q4 Revenue for manufacturing and royalty SEK 128 M (148) 200 800 • Phasing impacts delivery between the quarters 150 600 Q4 Manufacturing revenue 100 400 SEK 120 M (145) 50 200 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 FY was SEK 594 M
Slide 21: Pipeline
Pipeline
Slide 22: Pipeline
Pipeline • FPI in phase 2 study anaGO to evaluate anakinra for the treatment of acute gout • FPI in the anaSTILL’s study evaluating anakinra for the treatment of Still’s SOBI003 - chemically disease modified recombinant human sulfamidase • Fast Track status for SOBI003 for the treatment of MPS IIIA
Slide 23: Financial results
Financial results Mats-Olof Wallin
Slide 24: Profit & loss statement
Profit & loss statement Amounts in SEK M Q4-17 Q4-16 Full year-17 Full year-16 Total revenues 1,875 1,292 6,511 5,204 Gross profit 1,337 860 4,657 3,651 Gross Margin 71% 67% 72% 70% Sales and Administration -477 -399 -1,644 -1,366 Research and development -228 -258 -908 -778 Other operating revenues
Slide 25: Balance sheet
Balance sheet Amounts in SEK M Dec 2017 Sep 2017 Dec 2016 ASSETS Intangible 6,445 6,535 6,806 Tangible and other 301 277 257 Total non-current assets 6,746 6,812 7,063 Inventories 1,053 1,095 870 Accounts receivable 1,129 941 769 Other Receivable 496 469 487 Cash and equivalent 1,478 1,758 786 Total
Slide 26: Summary
Summary Guido Oelkers
Slide 27: Outlook 2018
Outlook 2018 • Sobi expects total revenues for the full-year to be in the range of SEK 7,500 – 7,700 M • Gross margin is expected to be at least 70 per cent • Sobi expects EBITA for the full-year to be in the range of SEK 2,500 – 2,700 M Set up a discrete BU for Specialty Care and focus organization
Slide 28: Our strategic position today
Our strategic position today Accomplished successful inroads in multiple markets in Haemophilia Drive commercial effectiveness agenda in Haemophilia Establish a Specialty Care business and strengthen its focus Establish late stage pipeline Expansion in NA 28
Slide 29: Our strategic direction
Our strategic direction Further internationalisation and commercialisation of Haemophilia Build Specialty Care as a preferred partner Vision Global leader in providing access to innovative treatments that make a significant Strengthen position difference for individuals in the US and EMENAR with rar
Slide 30: Q&A
Q&A
Slide 31: Pioneer in Rare Diseases
@sOobl Pioneer in Rare Diseases
Swedish Orphan Biovitrum AB (Sobi) — Q4 2017 Earnings Presentation on 6ix