Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q3 2016 Earnings Presentation
29 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Oct 27, 2016
Slide 1: Q3 results presentation
Geoffrey McDonough | CEO Alan Raffensperger | COO Mats-Olof Wallin | CFO 27 October 2016 Q3 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 Q3 2016
Business summary Q3 2016 • Elocta® reimbursed in the UK, Italy, France and Spain • Alprolix® reimbursed in the UK • Long term Elocta and Alprolix data presented at WHF 2016 World Congress • Orfadin® capsule filing validated by Health Canada • Milan Zdravkovic appointed as SVP, Head of R&D 3
Slide 4: Significant events after the reporting period
Significant events after the reporting period • European Commission grants SOBI003 orphan designation for the treatment of MPS IIIA • MAH transfer of Alprolix to Sobi approved by European Commission 4
Slide 5: Highlights Q3 2016
Highlights Q3 2016 1 600 • Total revenue: SEK 1,171 M (786) 1 400 • 49% growth (49% at CER) 1 200 • Product revenue: SEK 1,009 M (645) • 56% growth (57% at CER) 1 000 Total revenue • ReFacto revenue: SEK 162 M (140) 800 • Gross margin 67% (62%) 600 Product revenue • EBITA: SEK 282 M (97) 400 • Cash
Slide 6: YTD financials
YTD financials 1 600 • Total revenue: SEK 3,913 M (2,414) 1 400 • 62% growth (64% at CER) 1 200 • Product revenue: SEK 3,404 M (1,870) • 82% growth (84% at CER) 1 000 Total revenue • ReFacto revenue: SEK 508M (544) 800 • Gross margin 71% (62%) 600 Product revenue • EBITA: SEK 1,334M (343) 400 • Cash
Slide 7: YTD financials excluding one-time credits
YTD financials excluding one-time credits 1 400 • Total revenue: SEK 3,205 M (2,414) 1 200 • 33% growth (35% at CER) • Product revenue: SEK 2,697 M (1,870) 1 000 • 44% growth (46% at CER) Total revenue • ReFacto revenue: SEK 508 M (544) 800 • Gross margin 65% (62%) Product revenue 600 • EBITA: SEK 6
Slide 8: YTD 2016 revenue by business line
YTD 2016 revenue by business line SEK 573 M SEK 814 M SEK 1,401 M SEK 617 M USD 68 M USD 97 M USD 167 M USD 73 M +2%* +24%* >100%* 8%* SEK 508 M, USD 61 M -6%* *Growth at Constant Exchange Rates USD 1 = SEK 8,3985 8
Slide 9: ReFacto
ReFacto • Revenue for manufacturing and royalty SEK 162 M (140) • increase of 15% Revenues (SEK M): ReFacto 250 1 000 • YTD revenue SEK 508 M (544) 200 800 • decrease of 7% 150 600 • Manufacturing revenue 100 400 SEK 145 M (109) 50 200 • Royalty revenue SEK 17 M (31) 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q
Slide 10: Commercial results Q3 2016
Commercial results Q3 2016 Alan Raffensperger │ COO
Slide 11: Kineret
Kineret • Revenue SEK 265 M (215) Revenues (SEK M): Kineret • increase of 23% 300 1 200 • YTD revenues SEK 735 M (583) 250 1 000 • YTD increase of 26% 200 800 • Volume growth in all markets 150 600 • US distribution model is improving 100 400 patient support 50 200 0 0 • INDs filed for Kineret clini
Slide 12: Orfadin
Orfadin • Revenue SEK 193 M (200) Revenues (SEK M): Orfadin • decrease of 3% 250 1 000 • YTD revenue SEK 573 M (568) 200 800 • increase of 1% 150 600 • Oral Suspension + 20mg capsule 100 400 • driving growth in Europe • in early launch in US 50 200 • Generic approval 0 0 • Turkey Q1 Q2 Q3 Q4 Q1 Q2 Q
Slide 13: Partner Products
Partner Products • Revenue SEK 217 M (172) Revenues (SEK M): Partner Products • increase of 26% 250 1 000 • includes one time-payment from Exelixis of SEK 24 M 200 800 • YTD revenue SEK 617 M (578) 150 600 • increase of 7% 100 400 • Revenue growth supported by 50 200 PharmaSwiss portfolio and Xiapex
Slide 14: Haemophilia
Haemophilia • Revenue SEK 308 M (29) Revenues (SEK M): Haemophilia – SEK 73 M (0) in sales 700 – SEK 235 M (29) royalty revenue 600 500 • YTD revenue SEK 1 401 M (65) 400 300 200 100 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2015 2016 Royalty Sales Milestone One-time credit 14
Slide 15: Haemophilia – Biogen revenues
Haemophilia – Biogen revenues Alprolix - Biogen Sales (million US$) Eloctate - Biogen Sales (million US$) 120 120 110 110 99 100 96 100 87 80 80 72 65 67 63 59 60 60 60 53 49 41 37 37 40 40 25 22 22 17 19 20 14 20 9 10 11 10 5 5 7 2 4 4 2 0 0 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 16: Elocta
Elocta • Revenue SEK 198 M (17) Revenues (SEK M): Elocta • SEK 57 M (0) in sales 500 • SEK 141 M (17) royalty revenue 400 • YTD revenue SEK 835 M (37) 300 200 100 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2015 2016 Royalty Sales One-time credit 16
Slide 17: Elocta launch update
Elocta launch update • Revenue for the quarter derived mainly from Germany, Ireland, Scotland – Slow patient switching during the summer period • National reimbursement in all major markets now in place with Italy, Spain, England, and France late in the quarter • Regional reimbursement process under
Slide 18: Elocta access update
Elocta access update - Early September Reimbursement granted – treatment available Pricing & reimbursement decision-making in process FI NO SE DK IE NL LUX UK PO BE DE SK CZ AT HU FR CH SL RO IT BG ES PT Algeria Kuwait Saudi Arabia UAE 18
Slide 19: Elocta access update
Elocta access update - Late September Reimbursement granted – treatment available Pricing & reimbursement decision-making in process FI NO SE DK IE NL LUX UK PO DE BE SK CZ AT HU FR CH SL RO IT BG ES PT Algeria Kuwait Saudi Arabia UAE 19
Slide 20: Alprolix
Alprolix • Revenue SEK 110 M (13) Revenues (SEK M): Alprolix • SEK 16 M (0) in sales 500 • SEK 93 M (13) royalty revenue 400 • YTD revenue SEK 566 M (28) 300 including milestone (SEK 14 M) 200 100 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2015 2016 Royalty Sales Milestone One-time credit 20
Slide 21: Alprolix launch update
Alprolix launch update • Revenue from the quarter derived mainly from Germany and the UK • Value proposition well received • National reimbursement process ahead of schedule, following the Elocta experience Reimbursement granted – treatment available Pricing & reimbursement decision-making in proces
Slide 22: Financial results Q3 2016
Financial results Q3 2016 Mats-Olof Wallin│ CFO
Slide 23: Profit and Loss statement
Profit and Loss statement Amounts in SEK M Q3-16 Q3-15 Jan-Sep-16 Jan-Sep-15 FY 2015 Total revenues 1 171 786 3 913 2 414 3 228 Gross profit 782 486 2 791 1 486 2 007 Gross Margin 67% 62% 71% 62% 62% Sales and Administration -327 -272 -967 -764 -1 057 Research and development -179 -120 -520 -379 -51
Slide 24: Balance Sheet
Balance Sheet Amounts in SEK M Sep 2016 Dec 2015 Sep 2015 ASSETS Intangible 6 893 5 787 4 145 Tangible and other 254 208 185 Total non-current assets 7 147 5 995 4 330 Inventories 798 776 758 Accounts receivable 628 451 498 Other Receivable 398 185 172 Cash and equivalent 824 904 914 Total current a
Slide 25: Summary
Summary Geoffrey McDonough│ CEO 25
Slide 26: Outlook 2016 – Raised
Outlook 2016* – Raised Revenues Sobi now expects total revenues for the full year to be in the range of SEK 5,125 - 5,200 M (4,800-5,000) Gross margin Gross margin is expected to be 70 per cent (68-70) EBITA Sobi now expects EBITA for the full year to be in the range of SEK 1,475 -1,525 M (1,200-1,3
Slide 27: 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 28: Building on Sobi strengths
Building on Sobi strengths 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 Euro
Slide 29: Pioneer in Rare Diseases
@SODI Pioneer in Rare Diseases 29
Swedish Orphan Biovitrum (Sobi) — Q3 2016 Earnings Presentation on 6ix