Swedish Orphan Biovitrum AB · OMXSTO:SOBI
Swedish Orphan Biovitrum AB — FY2015 Earnings Presentation
40 slides from Swedish Orphan Biovitrum AB's earnings presentation, Feb 26, 2016
Slide 1: Q4 and FY results presentation 2015
Q4 and FY results presentation 2015 Geoffrey McDonough │ CEO Alan Raffensperger │ COO Mats-Olof Wallin │ CFO Stockholm | 26 February 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 Q4 2015
Business summary Q4 2015 • Elocta® (efmoroctocog alfa) approved in Europe for the treatment of haemophilia A • New data showed that Elocta and Alprolix® (rFIXFc) reduced target joint bleeds in people with haemophilia over a longer observation time • Sobi and Biogen initiated deliveries of largest ev
Slide 4: Significant events after the quarter
Significant events after the quarter • Announced commercial launch of Elocta in first countries in EU • Gained commercial rights for Relistor®, Deflux® and Solesta® from PharmaSwiss • Sobi's Orfadin® oral suspension granted European patent • Announced initiation of clinical development programs in a
Slide 5: Highlights Q4 2015
Highlights Q4 2015 • Total revenues: SEK 814 M (705) 1 000 • 15% growth (9% at CER) 900 • Product revenues: SEK 698 M (575) 800 Total Revenue • 21% growth (13% at CER) 700 • ReFacto® revenues: SEK 116 (130) • 11% decrease 600 500 • Gross margin 64% (60) Product Revenue 400 300 • EBITA: SEK 90 M (38)
Slide 6: Highlights FY 2015
Highlights FY 2015 1 000 • Total revenues: SEK 3,228 M (2,607) 900 • 24% growth (14% at CER) Total Revenue 800 • Product revenues: SEK 2,568 M (1,989) • 29% growth (18% at CER) 700 • ReFacto® revenues: SEK 660 (618) 600 • 7% increase 500 Product Revenue 400 • Gross margin 62% (59) 300 ReFacto Revenu
Slide 7: YTD 2015 revenue by business line
YTD 2015 revenue by business line SEK 940 M SEK 805 M SEK 96 M SEK 727 M USD 111 M USD 95 M USD 11 M USD 86 M +28%* +17%* >100%* +1%* *Growth at Constant Exchange Rates SEK 660 M, USD 78 M +2%* USD 1 = SEK 8,435 7
Slide 8: ReFacto AF®
ReFacto AF® • Revenue for manufacturing and royalty Revenues (SEK M): ReFacto 250 750 SEK 116 M (130) • Decrease of 11% 200 600 • Phasing effects caused by higher deliveries in the first half 2015 150 450 100 300 • Manufacturing revenue SEK 89 M (99) 50 150 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 0 •
Slide 9: Commercial results Q4 & FY 2015
Commercial results Q4 & FY 2015 Alan Raffensperger │ COO
Slide 10: Kineret®
Kineret® • Revenue SEK 222 M (163) Sales (SEK M): Kineret • Increase of 36% 250 1 000 200 800 • YTD was SEK 805 M (609) • Increase of 32% 150 600 100 400 • Continued growth in major markets, in line with ongoing development of 50 200 the CAPS and NOMID indications 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q
Slide 11: Orfadin
Orfadin • Revenue SEK 227 M (169) Sales (SEK M): Orfadin • Increase of 35% 250 1 000 200 800 • YTD was SEK 796 M (548) • Increase of 45% 150 600 100 400 • Growth in all major markets 50 200 • Launch of liquid suspension 0 0 underway Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2013 2014 2015 Quarterly 4Q-rol
Slide 12: Partner Products
Partner Products • Revenue SEK 178 M (198) Sales (SEK M): Partner Products • Decrease of 10% 250 800 • Discontinued products account for quarter 700 to quarter variation 200 600 150 500 • FY revenue SEK 727 M (682) 400 • Increase of 7% 100 300 200 • Growth mainly driven by Xiapex, 50 100 Cometriq® a
Slide 13: Haemophilia
Haemophilia Revenues (SEK M): Haemophilia • Revenue SEK 32 M (12) 35 • SEK 30 M in royalty revenues and SEK 2 M in 30 NPU sales 25 20 • Full year revenue of SEK 96 M (31) 15 • SEK 94 M in royalty revenues and SEK 2 M in NPU sales 10 5 0 • Elocta received approval in Europe on Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Slide 14: Haemophilia – Biogen revenues
Haemophilia – Biogen revenues ALPROLIX Revenue ($M) ELOCTATE Revenue ($M) $71 $66 $101 $11 $91 $5 $7 $54 $74 $4 $5 $43 $40 $2 $2 $54 $4 ROW $60 $0.4 $96 US $59 $37 $87 $49 ROW US $72 $41 $37 $53 $37 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 Q4-14 Q1-15 Q2-15 Q3-15 Q4-15 14
Slide 15: Financial results Q4 & FY 2015
Financial results Q4 & FY 2015 Mats-Olof Wallin │ CFO
Slide 16: Profit and Loss statement
Profit and Loss statement Amounts in SEK M Q4-15 Q4-14 FY 2015 FY 2014 • Improved GM – favourable Total revenues 814 705 3 228 2 607 product mix and positive currency impact Gross profit 520 427 2 007 1 548 Gross Margin 64% 60% 62% 59% Sales and Administration -293 -214 -1 057 -750 • Increase in S&A
Slide 17: Balance Sheet
Balance Sheet Amounts in SEK M Dec 2015 Dec 2014 ASSETS • Intangible assets and Intangible 5 787 4 248 liabilities impacted by the Tangible and financial 208 188 approval of Elocta in Q4 Total non-current assets 5 995 4 436 Inventories 776 764 2015 Accounts receivable 451 480 Other Receivable 185 17
Slide 18: Net cash/debt
Net cash/debt 500 50% • Cash SEK 904 M 40% 400 • Net cash SEK 82 M 30% 300 20% SEK M 200 10% 100 0% 0 -10% Q3-15 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 Q1-15 Q2-15 Q4-15 -100 -20% Net debt Net debt / Equity 18
Slide 19: PnL impact of Elocta launch
PnL impact of Elocta launch Up to Launch Launch: January 2016 MAH transfer: 2016 • Base cross royalty rate • One-time credit booked • Sobi will assume 50% between Sobi and as revenue (no cash development activity Biogen is 12% effect); ~USD 38 M and costs in 2016 • Royalty to Sobi of 2% • Royalty to
Slide 20: Outlook 2015
Outlook 2015 Revenues Revenues for the full year were SEK 3,228 M, above the predicted range of SEK 3,000 to 3,200 M Gross Margin Gross margin for the full year was 62 per cent, above the expected range of 59 to 61 per cent EBITA – range revised EBITA for the full year was SEK 433 M above the set ra
Slide 21: Summary and outlook
Summary and outlook Geoffrey McDonough │ CEO
Slide 22: Outlook 2016
Outlook 2016 Revenues Sobi expects total revenues for the full year to be in the range of SEK 4,300 to 4,500 M Gross Margin Gross margin is expected be in the range of 66 to 68 per cent EBITA Sobi expects EBITA for the full year to be in the range of SEK 700 to 800 M Note: 2016 will be impacted by a
Slide 23: What happens at Alprolix launch?
What happens at Alprolix launch? Revenue • One time credit • Product sales • Incremental royalty 2 12 per cent Costs • Incremental costs for Sobi’s share of ongoing costs for Alprolix 23
Slide 24: Haemophilia update
Haemophilia update 24
Slide 25: Haemophilia A in Sobi territory
Haemophilia A in Sobi territory Size of market in Sobi territory* USD 3.3 B SEK 23 B Sobi territory Biogen territory *Source: MRB, 2011, includes all patients (mild, moderate, severe) 25
Slide 26: Elocta launch update
Elocta launch update Elocta launch ongoing: • Germany, UK, Denmark, Netherlands, Ireland • Availability in the Middle East for commercial use The importance of improved protection recognised by the community Initial prescriber feedback: “Lets my patients live more naturally” - Abu Dhabi haemophilia
Slide 27: Elocta Indication and prophylactic dosing guidance
Elocta Indication and prophylactic dosing guidance1 Elocta® is indicated for the treatment and prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) Elocta® can be used in all age groups For long-term prophylaxis the The dose may be adjusted based on rec
Slide 28: A-LONG; Reduced ABRs with similar weekly Elocta consumption
A-LONG; Reduced ABRs with similar weekly Elocta consumption1,2 Sub-analysis of subjects with pre-study prophylaxis and on-study individualized prophylaxis for ≥ 6 months (n=80) 12 months prior to study ≥ 6 months on rFVIIIFc Median weekly factor consumption (IU/kg) Similar weekly 1 78.0 vs. 79.2* co
Slide 29: A year of prophylaxis with conventional FVIII
A year of prophylaxis with conventional FVIII (every other day dosing)* In practice most commonly used dosing regimens with conventional FVIII are three times per week or every other day1, 2, 3 * Slide from M. Carcao 1. Meunier et al. International Society on Thrombosis and Haemostasis, 29 June–4 Ju
Slide 30: A year of prophylaxis with extended half-life FVIII
A year of prophylaxis with extended half-life FVIII (twice per week dosing)* Median dosing frequency with rFVIIIFc in A-LONG was twice weekly1 * Slide from M. Carcao 1. Mahlangu et al. Blood 2014 (individualised prophylaxis arm) 30
Slide 31: EAHAD Congress Malmö 3rd – 5th February 2016
EAHAD Congress Malmö 3rd – 5th February 2016 European Association for Haemophilia and Allied Disorders • 1600 delegates from across Europe and beyond • Sobi symposium: “TREATMENT GOALS IN HAEMOPHILIA: REDEFINING PROTECTION” • 800 plus attendees • Pivotal Elocta data: A-LONG & Kids A-LONG • Long-term
Slide 32: Long term outcomes data from ASPIRE
Long term outcomes data from ASPIRE A-LONG Kids A-LONG ASPIRE PUPs A-LONG 2010 2011 2012 2013 2014 2015 2016 32
Slide 33: Long term outcomes data from ASPIRE*
Long term outcomes data from ASPIRE* • Median time on ASPIRE: 126.9 weeks • Median cumulative duration on A-LONG + ASPIRE: 158.2 weeks • 87.3 % had ≥150 Elocta EDs A-LONG†1 ASPIRE data cut 1†2 ASPIRE data cut 2†3 Median ABR 1.6 0.7 0.8 Injection 3.5 days (median) 93.8% same or 93.8% same or Frequenc
Slide 34: Elocta has a favourable safety profile after long-term exposure
Elocta has a favourable safety profile after long- term exposure1,2 No inhibitors* were observed on-study, as of the 2nd interim data cut Adverse events were typical of a haemophilia A population Most common TEAEs1 • Nasopharyngitis (20.7%) • Upper respiratory tract infection (11.3%) • Arthralgia (1
Slide 35: Alprolix approval & launch planning
Alprolix approval & launch planning • Alprolix CHMP opinion imminent • European Commission decision anticipated H1 2016 • Would enable launch mid-year 2016 35
Slide 36: Kineret update
Kineret update 36 _
Slide 37: Evolution of Kineret
Evolution of Kineret Kineret Features: Kineret features Kineret Features: Systemic/Joint • Adult Onset Still’s Disease • Strong evidence of effect in treating IL-1 • Myositis mediated diseases • PAPA syndrome • SJIA • Rapid onset + short duration of action • Macrophage Activation Syndrome • Well-cha
Slide 38: Acute Gout and Still's disease
Acute Gout and Still’s disease Acute Gout Still’s disease (SJIA & AOSD) • Quick onset and short duration of • No approved pharmaceutical treatment immunosuppression preferred for AOSD • Targeted segment unsuitable for • Targeting patients who are eligible for IL- standard therapy and have ≥ 3 1 bloc
Slide 39: Patent BV-1228: citrate free anakinra composition
Patent BV-1228: citrate free anakinra composition Kineret – a citrate free formulation • Meets a need in the patient community • Patent granted in US, China and New Zealand to date • EU and Hong Kong patent applications have been allowed • Patent expiry in February 2032 39
Slide 40: 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
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