Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q1 2016 Earnings Presentation
25 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Apr 27, 2016
Slide 1: Q1 results presentation
Geoffrey McDonough │ CEO Alan Raffensperger │ COO Mats-Olof Wallin │ CFO Stockholm | 27 April 2016 Q1 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 Q1 2016
Business summary Q1 2016 • Commercial launch of Elocta® in the first European countries • Sobi and Biogen received CHMP recommendation for Alprolix® for the treatment of haemophilia B • Sobi received commercialisation rights to three products from PharmaSwiss • European patent granted for Orfadin® O
Slide 4: Significant events after the quarter
Significant events after the quarter • COMP recommended to maintain orphan designation for Alprolix • European patent granted on new formulation of Kineret • Signed licensing agreement with Affibody for IL-1 • Orfadin Oral Suspension approved in the US 4
Slide 5: Highlights Q1 2016
Highlights Q1 2016 1 400 • Total revenue: SEK 1,273 M (865) 1 200 47% growth (48% at CER) • Product revenue: SEK 1,108 M (632) 1 000 75% growth (76% at CER) Total revenue • ReFacto® revenue: SEK 165 (232) 800 29% decrease 600 • Gross margin 74% (60) Product revenue 400 • EBITA: SEK 502 M (172)
Slide 6: Highlights Q1 2016 Excluding Elocta one-time credit
Highlights Q1 2016 Excluding Elocta one-time credit 1 000 • Total revenues SEK 951 M (865) 900 10% growth 800 Total revenue • Product revenue: SEK 786 M (632) 700 24% growth • ReFacto revenue: SEK 165 (232) 600 29% decrease Product revenue 500 400 • Gross margin 65% (60) 300 ReFacto revenue •
Slide 7: Q1 2016 revenue by business line
Q1 2016 revenue by business line SEK 198 M SEK 256 M SEK 465 M SEK 187 M USD 23 M USD 30 M USD 55 M USD 22 M +10%* +14%* >100%* -10%* SEK 165 M, USD 20 M -29%* *Growth at Constant Exchange Rates USD 1 = SEK 8,4567 7
Slide 8: ReFacto
ReFacto • Revenue for manufacturing and Revenues (SEK M): ReFacto royalty SEK 165 M (232) 250 750 Decrease of 29% Phasing effects caused by higher 200 600 deliveries in the first half 2015 150 450 • Manufacturing revenue 100 300 SEK 137 M (208) 50 150 • Royalty revenue SEK 28 M (25) 0 0 Q1 Q2 Q3
Slide 9: Commercial results Q1 2016
Commercial results Q1 2016 Alan Raffensperger │ COO
Slide 10: Kineret
Kineret • Revenue SEK 227 M (198) Revenues (SEK M): Kineret Increase of 15% 250 1,000 200 800 • Solid growth in major markets Continued launch in CAPS indication 150 600 in Europe New specialty distribution model in 100 400 North America 50 200 • New clinical development programs 0 0 Acute g
Slide 11: Orfadin
Orfadin • Revenue SEK 198 M (180) Revenues (SEK M): Orfadin Increase of 10% 240 900 220 800 200 • Growth in all major markets 180 700 160 600 140 500 • Launch of oral suspension in first 120 400 100 countries in Europe 80 300 Oral Suspension now launched and 60 200 generating revenue in Finland,
Slide 12: Partner Products
Partner Products • Revenue SEK 187 M (212) Revenues (SEK M): Partner Products Decrease of 11% 250 1,000 200 • Signed agreement with PharmaSwiss 750 150 500 • Growth especially driven by Xiapex® 100 250 • Q1 2015 included: 50 SEK 22 M Cometriq® milestone and 0 0 service fee Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q
Slide 13: Haemophilia – Biogen revenues
Haemophilia – Biogen revenues Alprolix - Biogen Sales (million US$) Eloctate - Biogen Sales (million US$) 96 99 87 72 65 59 60 53 49 41 37 37 25 22 10 11 10 9 4 5 5 7 4 5 0 0 0 0 0 0 2 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 2014 2015 2016 2014 2015 2016 North America ROW North America
Slide 14: Haemophilia
Haemophilia • Revenue SEK 465 M (17) Revenues (SEK M): Haemophilia SEK 445 M in royalty revenues 500 SEK 123 M royalty SEK 322 M was a one-time 400 royalty credit Elocta sales SEK 20 M 300 • Marketing authorisation in the EU 200 transferred to Sobi 100 • Alprolix received a positive 0 recomm
Slide 15: Elocta launch progress
Elocta launch progress Q1 2016 update • Revenue from the quarter derives almost exclusively from Germany, the only market in the EU where pharmaceuticals are immediately reimbursed upon EU approval • Reimbursement is available in the UK for a limited number of patients until the framework agreement
Slide 16: Alprolix launch preparations
Alprolix launch preparations Q1 2016 update • Alprolix CHMP Positive Opinion received 25th February 2016 • Positive opinion to maintain OMP status received 5th April 2016 • European Commission decision anticipated shortly • Launch sequence will be similar to Elocta 16
Slide 17: Financial results Q1 2016
Financial results Q1 2016 Mats-Olof Wallin │ CFO
Slide 18: Profit and Loss statement
Profit and Loss statement Amounts in SEK M Q1-16 Q1-15 FY 2015 • Improved GM due to Total revenues 1,273 865 3,228 increased royalty revenues Gross profit 944 519 2,007 Gross Margin 74% 60% 62% Sales and Administration -315 -219 -1,057 • Increase in S&A Research and development -138 -132 -513 expens
Slide 19: Balance sheet
Balance sheet Amounts in SEK M March 2016 Dec 2015 March 2015 • Inventory build up to ASSETS reflect ongoing Intangible 5,661 5,787 4,192 haemophilia launch Tangible and other 194 208 189 Total non-current assets 5,854 5,995 4,380 Inventories 810 776 765 • Positive cash flow in Accounts receivable 5
Slide 20: Net cash
Net cash 400 20% • Cash SEK 1,108 M 300 200 10% • Net cash SEK 305 M 100 SEK M 0 0% Q1-14 Q2-14 Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 Q1-16 -100 -200 -10% -300 -400 -20% Net cash (-)/debt(+) Net cash/debt / Equity 20
Slide 21: PnL impact of Elocta launch
PnL impact of Elocta launch Up to Launch Launch: January 2016 MAH transfer: March 2016 • Base cross royalty rate • One-time credit booked between Sobi and as revenue (no cash • Sobi has assumed 50% Biogen is 12% effect); ~USD 38 M development activity and costs in 2016 • Royalty to Sobi of 2% • Roya
Slide 22: Summary
Summary Geoffrey McDonough│ CEO 22
Slide 23: 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 M Gross Margin Gross margin is expected be in the range of 68 to 70 per cent EBITA Sobi expects EBITA for the full year to be in the range of SEK 1,200 to 1,300 M Revenue will inc
Slide 24: 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 25: Pioneer in Rare Diseases
@SODI Pioneer in Rare Diseases 25
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