Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q2 2016 Earnings Presentation
27 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Jul 15, 2016
Slide 1: Q2 results presentation 2016
Geoffrey McDonough │ CEO Alan Raffensperger │ COO Stockholm | 15 July 2016 Q2 results presentation 2016
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: Business summary Q2 2016
Business summary Q2 2016 • Alprolix® approved in the EU; first sales reported in Germany • Elocta® approved in Switzerland • European patent granted for new Kineret® formulation • Signed licensing agreement with Affibody for IL-1 • Signed manufacturing agreements with Pfizer • Orfadin® Oral Suspensi
Slide 4: Significant events after the reporting period
Significant events after the reporting period • Health Canada validates Orfadin® capsule filing 4
Slide 5: Highlights Q2 2016
Highlights Q2 2016 1 600 • Total revenue: SEK 1,469 M (764) 1 400 • 92% growth (95% at CER) • Product revenue: SEK 1,288 M (593) 1 200 • >100% growth (>100% at CER) • incl. a one-time credit of SEK 386 M 1 000 Total revenue • ReFacto revenue: SEK 181 (172) 800 • 6% increase 600 • Gross margin 72% (6
Slide 6: Highlights H1 2016
Highlights H1 2016 1 600 • Total revenue: SEK 2,742 M (1,629) 1 400 • 68% growth (71% at CER) • Product revenue: SEK 2,395 M (1,225) 1 200 • 96% growth (98% at CER) Total revenue • incl. one-time credits of SEK 708 M 1 000 • ReFacto revenue: SEK 346 (404) 800 • 14% decrease 600 • Gross margin 73% (6
Slide 7: Highlights H1 2016 excluding one-time credits
Highlights H1 2016 excluding one-time credits 1 200 • Total revenue: SEK 2,034 M (1,629) • 25% growth (27% at CER) 1 000 Total revenue • Product revenue: SEK 1,687 M (1,225) • 38% growth (40% at CER) 800 • ReFacto revenue: SEK 346 (404) • 14% decrease 600 Product revenue • Gross margin 64% (61) 400
Slide 8: YTD 2016 revenue by business line
YTD 2016 revenue by business line SEK 379 M SEK 524 M SEK 1,093 M SEK 399 M USD 45 M USD 63 M USD 131 M USD 48 M +4%* +28%* >100%* 0%* SEK 346 M, USD 42 M -13%* *Growth at Constant Exchange Rates USD 1 = SEK 8,3331 8
Slide 9: ReFacto
ReFacto • Revenue for manufacturing and royalty SEK 181 M (172) • Increase of 6% Revenues (SEK M): ReFacto 250 1,000 200 800 • YTD revenue SEK 346 M (404) • Decrease of 14% 150 600 100 400 50 200 • Manufacturing revenue 0 0 SEK 142 M (99) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2014 2015 2016 • Royalty revenu
Slide 10: Commercial results Q2 2016
Commercial results Q2 2016 Alan Raffensperger │ COO
Slide 11: Kineret
Kineret • Revenue SEK 243 M (171) • Increase of 43% Revenues (SEK M): Kineret 250 1,000 • YTD revenues SEK 471 M (369) 200 800 • YTD increase of 28% 150 600 • Strong organic growth across markets 100 400 50 200 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2014 2015 2016 Quarterly 4Q-rolling 11
Slide 12: Orfadin
Orfadin • Revenue SEK 182 M (189) • Decrease of 4% Revenues (SEK M): Orfadin 250 1,000 • YTD revenue SEK 379 M (369) 200 800 • Increase of 3% 150 600 • Growth in Europe supported by the 100 400 continued launch of oral suspension 50 200 0 0 • US lower due to higher than average Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 13: Partner Products
Partner Products • Revenue SEK 212 M (195) • Increase of 9% Revenues (SEK M): Partner Products 250 1,000 • YTD revenue SEK 399 M (406) 200 800 • Decrease of 2% 150 600 • Continued strong growth for Xiapex® 100 400 50 200 • Revenue growth also supported by 0 0 new PharmaSwiss partnership Q1 Q2 Q3 Q4
Slide 14: Haemophilia
Haemophilia • Revenue SEK 627 M (18) • YTD revenue SEK 1 093 M (35) Revenues (SEK M): Haemophilia 700 600 500 400 300 200 100 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2014 2015 2016 14
Slide 15: Elocta
Elocta • Revenue SEK 184 M (11) • SEK 129 M (11) estimated royalty Revenues (SEK M): Elocta/Eloctate revenue* 500 • SEK 55 M (0) in sales 400 • YTD revenue SEK 637 M (20) 300 200 • Approved in Switzerland in June 100 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2014 2015 2016 Quarterly One-time credit *Royalty e
Slide 16: Elocta launch progress Q2 2016 update
Elocta launch progress Q2 2016 update • Revenue from the quarter derived mainly from Germany and the Middle East, with first sales also in UK, Ireland and Sweden • Reimbursement for Elocta now granted in Germany, the Netherlands, Ireland, and Sweden • UK: NHS Framework agreements in place for Elocta
Slide 17: Alprolix
Alprolix • Revenue SEK 444 M (8) • SEK 39 M (8) estimated royalty Revenues (SEK M): Alprolix revenue* 500 • SEK 386 M (0) one-time credit 400 • SEK 5 M (0) sales • SEK 14 M (0) milestone revenue for 300 EMA approval of Alprolix 200 100 • YTD revenue SEK 456 M (15) 0 • Alprolix approved in EU 12 May
Slide 18: Alprolix launch preparations Q2 2016 update
Alprolix launch preparations Q2 2016 update • Revenue from the quarter derives mainly from Germany and the Middle East, with first sales also in UK • Reimbursement for Alprolix now granted in Germany, the Netherlands, and Ireland • UK: NHS Framework agreements in place for Alprolix (effective 1 Sept
Slide 19: Financial results Q2 2016
Financial results Q2 2016 Geoffrey McDonough│ CEO
Slide 20: Profit and Loss statement
Profit and Loss statement Amounts in SEK M Q2-16 Q2-15 H1-16 H1-15 FY 2015 • Improved Gross margin due to Total revenues 1 469 764 2 742 1 629 3 228 increased royalty revenues Gross profit 1 065 482 2 009 1 001 2 007 Gross margin 72% 63% 73% 61% 62% • Increase in S&A expenses Sales and Administratio
Slide 21: Balance sheet
Balance sheet Amounts in SEK M June 2016 Dec 2015 June 2015 • Increase in intangible assets ASSETS Intangible 6 974 5 787 4 128 and liabilities due to Tangible and other 192 208 199 Elocta/Alprolix approvals Total non-current assets 7 165 5 995 4 327 Inventories 751 776 742 Accounts receivable 558 4
Slide 22: Net cash
Net cash 400 50% • Cash SEK 770 M 300 40% 200 • Net cash SEK 266 M 30% 100 • The bond of SEK 800 M called and 20% SEK M repaid in the quarter 0 Q4-14 Q1-14 Q2-14 Q3-14 Q1-15 Q2-15 Q3-15 Q4-15 Q1-16 Q2-16 10% -100 • New term loan of SEK 500 M established in the quarter 0% -200 -10% • Substantially be
Slide 23: PnL impact of Alprolix launch
PnL impact of Alprolix launch Up to Launch Launch: June 2016 MAH transfer: expected in Q3 2016 • Base cross royalty rate • One-time credit booked between Sobi and as revenue (no cash • Sobi will assume 50% Biogen is 12% effect); ~USD 46 M development activity and costs in 2016 • Royalty to Sobi of 2
Slide 24: Summary
Summary Geoffrey McDonough│ CEO 24
Slide 25: Outlook 2016 unchanged
Outlook 2016 unchanged Revenues Sobi expects total revenues for the full year to be in the range of SEK 4,800 to 5,000 SEK Gross margin Gross margin is expected be in the range of 68 to 70 per cent EBITA - updated Sobi expects EBITA for the full year to be in the range of SEK 1,200 to 1,300 M 25
Slide 26: 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 – providing forward cash flow
Slide 27: Pioneer in Rare Diseases
@SODI Pioneer in Rare Diseases 27
Swedish Orphan Biovitrum (Sobi) — Q2 2016 Earnings Presentation on 6ix