Swedish Orphan Biovitrum AB · OMXSTO:SOBI
Swedish Orphan Biovitrum AB — Q3 2015 Earnings Presentation
33 slides from Swedish Orphan Biovitrum AB's earnings presentation, Oct 29, 2015
Slide 1: Q3 results presentation 2015
Q3 results presentation 2015 Geoffrey McDonough │ CEO Alan Raffensperger │ COO Mats-Olof Wallin │ CFO Stockholm | 29 October 2015
Slide 2: Business summary Q3 2015
Business summary Q3 2015 • Received positive opinion from CHMP for Elocta® for the treatment of Haemophilia A • Exercised opt-in right for Alprolix® • Received Australian regulatory approval for Kineret® for use in Systemic Juvenile Idiopathic Arthritis • Kineret received Orphan Drug Designation for
Slide 3: Business summary Q3 2015
Business summary Q3 2015 • Total revenues: SEK 786 M (666) 1 000 • 18% growth (8% at CER) 900 • Product revenues: SEK 645 M (532) 800 Total Revenue • 21% growth (10% at CER) 700 • ReFacto® revenues: SEK 140 (134) • 5% increase 600 500 • Gross margin 62% (59) Product Revenue 400 300 • EBITA: SEK 97 M
Slide 4: YTD 2015 revenue by business line
YTD 2015 revenue by business line Early Stage Development Programmes Haemophilia SEK 65 M USD 8 M >100%* Genetics & Inflammation SEK 583 M Metabolism +14%* +31%* SEK 672 M USD 69 M USD 80 M Partner Products SEK 549 M +7%* USD 65 M ReFacto AF SEK 544 M USD 65 M +6%* *Growth at Constant Exchange Rates
Slide 5: ReFacto AF
ReFacto AF • Revenue from manufacturing and royalty SEK 140 M (134) Sales (SEK M): ReFacto • Increase of 5% 300 900 • Phasing effects caused by higher deliveries in the first half 2015 200 600 • YTD was SEK 544 M (488) • Increase of 12% 100 300 • Manufacturing revenue SEK 109 M (92) 0 0 Q1 Q2 Q3 Q4
Slide 6: Commercial Results Q3 2015
Commercial Results Q3 2015 Alan Raffensperger │ COO
Slide 7: Kineret
Kineret • Revenue SEK 215 M (174) Sales (SEK M): Kineret • Increase of 23% 250 1,000 200 800 • YTD was SEK 583 M (446) • Increase of 31% 150 600 100 400 • Volume growth across most European markets 50 200 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 0 • The US market performed well driven 2013 2014 2015 by va
Slide 8: Orfadin
Orfadin • Revenue SEK 200 M (164) Sales (SEK M): Orfadin • Increase of 22% 250 1,000 • YTD was SEK 568 M (379) 200 800 • Increase of 50% 150 600 • Growth in all major markets 100 400 50 200 • FDA validated Orfadin oral suspension filing PDUFA 2Q 2016 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2013 2014
Slide 9: Partner Products
Partner Products • Revenue SEK 173 M (160) Sales (SEK M): Partner Products • Increase of 8% 250 1,000 200 800 • YTD was SEK 549 M (484) • Increase of 14% 150 600 100 400 • Increase driven by growth of 50 200 Cometriq® and Xiapex® 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 0 • Launch underway for Xiapex for
Slide 10: Haemophilia
Haemophilia Revenues (SEK M): Haemophilia • Revenue of SEK 29 M (8) • Based on 2% royalty of sales for Eloctate and 35 Alprolix in Biogen territory 30 • Q3 includes SEK 4 M (1) true-up from sales in 25 the second quarter 20 15 • YTD was SEK 65 M (19) 10 5 0 • Exercised opt-in right for Alprolix Q1 Q
Slide 11: Haemophilia – Biogen revenues
Haemophilia – Biogen revenues ALPROLIX Revenue ($M) ELOCTATE Revenue ($M) $66 $91 $7 $4 $54 $74 $5 $2 $43 $40 $54 $2 $4 $0.4 $37 $87 $25 $59 ROW ROW $72 $0.2 $49 $41 US $22 $53 US $37 $25 $37 $22 Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 11
Slide 12: EU Elocta and Alprolix Launches in 2016
EU Elocta and Alprolix Launches in 2016 • Launch will proceed country by country across Europe • Free access markets lead • Structured reimbursement markets follow Time to reimbursement varies from • Tender markets lag country to country in Europe • Payer engagement underway since 2013 • Reimburseme
Slide 13: Prophylaxis Therapy – Remaining Gaps
Prophylaxis Therapy – Remaining Gaps Patients on prophylaxis still bleed2-5 • UK registry data (all ages)4 • Severe Haemophilia A: median ABR 4.0 (n=126) • Severe Haemophilia B: median ABR 4.0 (n=36) • Canadian multi-centre study (≥18 years)5 • Severe Haemophilia A: median ABR 5 (n=155) ABR: Annuali
Slide 14: WFH Close the Gap Programme in Action
WFH Close the Gap Programme in Action Estimated 2015 WFH donation countries* Estimated 2020 WFH donation countries* 14
Slide 15: Financial Results Q3 2015
Financial Results Q3 2015 Mats-Olof Wallin │ CFO
Slide 16: Profit and Loss Statement
Profit and Loss Statement Jan-Sep Jan-Sep Amounts in SEK M Q3-15 Q3-14 2015 2014 FY 2014 Total revenues 786 666 2,414 1,902 2,607 Gross profit 486 395 1,486 1,121 1,548 Gross Margin 62% 59% 62% 59% 59% Sales and Administration -272 -187 -764 -536 -750 Research and development -120 -91 -379 -351 -501
Slide 17: Balance Sheet
Balance Sheet Amounts in SEK M Sept 2015 Sept 2014 Dec 2014 • Opt-In Alprolix USD 10 M ASSETS Intangible 4,145 4,231 4,248 Tangible and financial 185 183 188 Total non-current assets 4,330 4,414 4,436 • Launch inventory of Elocta Inventories 758 726 764 in place Accounts receivable 498 451 480 Other
Slide 18: Net cash/debt
Net cash/debt 500 50% • Cash SEK 914 M 40% 400 • Net cash SEK 92 M 30% 300 20% SEK M 200 10% 100 0% 0 -10% Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 Q1-15 Q2-15 Q3-15 -100 -20% Net debt Net debt / Equity 18
Slide 19: PnL impact of Elocta/Alprolix launches
PnL impact of Elocta/Alprolix launches Today On first commercial sale At MAH transfer • Base cross royalty rate • One-time credit equal • Sobi will assume 50% between Sobi and to 10% of accumulated development activity Biogen is 12% revenues from Biogen and costs in 2016 territory booked as • Sobi c
Slide 20: Summary and Outlook
Summary and Outlook Geoffrey McDonough │ CEO
Slide 21: Outlook 2015 – EBITA range revised
Outlook 2015 – EBITA range revised Revenues Sobi expects total revenues for the full year to be in the range of SEK 3,000 to 3,200 M Gross Margin Gross margin is expected be in the range of 59 to 61 per cent Operating Costs Operating costs are projected to increase as the company continues to prepar
Slide 22: Building our future
Building our future Continued 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 territories – providing forward cash
Slide 23: Anticipated early R&D pipeline end 2016
Anticipated early R&D pipeline end 2016 Indication Product/Project Partner Exploratory Preclin. Phase I Phase II Phase III Registration C5-driven disease Z-Fc MPSIIIA SOBI003 Modified IL-1-driven disease Anakinra Z molecule IL-1 –driven disease IL-1R antagonist Lysosomal Diseases GlyMod ERT XTEN-Fac
Slide 24: SOBI002: C5 Affibody:ABD inhibitor
SOBI002: C5 Affibody:ABD inhibitor • SOBI002 comprises a C5- binding Z domain and an albumin-binding domain Affibody-ABD • Half-life in animal models showed extended inhibition of C5 inhibitory Affibody • SOBI002 withdrawn from clinical trials in 2014 24
Slide 25: New candidate: C5 Affibody:Fc Fusion inhibitor
New candidate: C5 Affibody:Fc Fusion inhibitor • More stable version of C5- binding Z-domain identified • Fc fusion to Z-domain yields significant half-life extension over SOBI002 • Pre-CD selection in early 2016 will allow first-in- human studies in 2018 25
Slide 26: Mucopolysaccharidosis IIIA: Sanfilippo A
Mucopolysaccharidosis IIIA: Sanfilippo A • Rare disease with incidence of approx. 1 in 70,000 live births • Behavioral and motor-sensory disturbances in early childhood, with cognitive decline leading to death in the second decade of life • Current treatment is palliative • No treatments available w
Slide 27: MPSIIIA Mouse Model
MPSIIIA Mouse Model MPSIIIA mouse Wild type 27
Slide 28: Native Sulfamidase Does Not Access CNS
Native Sulfamidase Does Not Access CNS • Recombinant sulfamidase doesn’t get to the brain Liver Brain Data on file 28
Slide 29: SOBI003: Modified Sulfamidase
SOBI003: Modified Sulfamidase • Sulfamidase with proprietary modification approach • Goal is to enable penetration of the CNS with systemic IV treatment • Patent applications surrounding SOBI003 technology pending 29
Slide 30: Substrate Reduction in Brain in Mouse Model
Substrate Reduction in Brain in Mouse Model • Treatment with intravenously administered SOBI003 Liver Brain Data on file 30
Slide 31: SOBI003 present in brain tissue after IV administration
SOBI003 present in brain tissue after IV administration • MPSIIIA mouse cortex 6 h following vehicle 6 h following SOBI003 Data on file 31
Slide 32: Next steps
Next steps • Process development for SOBI003 ongoing (challenging) • Clinical material will be manufactured in Sobi’s facility in 2016 to enable GLP toxicity testing • First-in-human studies planned for 2018 32
Slide 33: Summary
Summary • Solid momentum in base business based on growth across the portfolio • Significant achievement of milestones for our extended half-life Haemophilia franchise • Elocta launch preparations on track for YE 2015 approval • Alprolix filing and opt-in in place • Early rare disease programs under
Swedish Orphan Biovitrum AB (Sobi) — Q3 2015 Earnings Presentation on 6ix