Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q2 2018 Earnings Presentation
28 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Jul 18, 2018
Slide 1: Q2 2018 Results
Q2 2018 Results 18 July 2018
Slide 2: Agenda and presenters
AGENDA PRESENTERS Guido Oelkers Chief Executive Officer and President Introduction Business review Financials Pipeline Mats-Olof Wallin Chief Financial Officer Summary CFO Milan Zdravkovic Head of Research & Development and Chief Medical Officer 1
Slide 3: 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 AB (publ) is providing the following cautionary statement, This presentation contains forward-looking statements with respect to
Slide 4: Q2 highlights
Q2 highlights • 40 per cent sales growth (36 per cent at CER) • Total revenues of SEK 2,289 M (1,639) • EBITA increased by 94 per cent to SEK 951 M (492) • Net cash position of SEK 2,300 M (1,472 as of 31 December 2017) • Revenues for Elocta® were SEK 794 M (351), an increase of 126 per cent • Reven
Slide 5: Financial highlights Q2 2018
Financial highlights Q2 2018 Total Revenue (SEK M) Q2 Q2 Change H1 H1 Change 2 500 2018 2017 (%) 2018 2017 (%) Revenues 2,289 1,639 +40 4,253 3,035 +40 2 000 (SEK M) 1 500 Gross margin 73% 71% 73% 72% 1 000 EBITA (SEK M) 951 492 +94 1,722 898 +92 500 EBITA margin 42% 30% 40% 30% 0 Cash flow from 564
Slide 6: Business review Q2
Business review Q2 Guido Oelkers 5
Slide 7: Haemophilia – growth based on innovation
Haemophilia – growth based on innovation • Safety established in thousands of patients • Unique use of Fc fusion technology in haemophilia utilising a natural pathway in the body • Provides opportunities for individualised treatment • For all age groups, in prophylaxis, on-demand and surgery • Mode
Slide 8: Haemophilia – product revenues over SEK 1 Bn in Q2
Haemophilia – product revenues over SEK 1 Bn in Q2 Total Revenues (SEK M) 1 600 • Q2 revenues of SEK 1,493 M (923) 1 400 ▪ SEK 1,057 M (434) in product revenues ▪ SEK 335 M (305) in royalty revenues 1 200 ▪ SEK 100 M (184) in manufacturing revenues 1 000 800 600 400 200 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Slide 9: Elocta – acceleration continues
Elocta – acceleration continues Product Revenues (SEK M) 900 • Q2 product revenues of SEK 794 M (351) 800 ▪ SEK 443 M (126 per cent) growth 700 ▪ Close to 60 per cent of the growth derived from 600 France, Germany, Italy and UK 500 400 • Reimbursed in 25 countries 300 200 100 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Slide 10: Alprolix – over 200 per cent revenue growth
Alprolix – over 200 per cent revenue growth Product Revenues (SEK M) 300 • Product revenues of SEK 263 M (84) 250 ▪ SEK 179 M (215 per cent) growth ▪ More than 70 per cent of the growth derived 200 from France, Germany, Italy and the Netherlands 150 100 • Reimbursed in 16 countries 50 0 Q1 Q2 Q3 Q4
Slide 11: Specialty Care – core strengths continue to deliver
Specialty Care – core strengths continue to deliver • World-class commercialisation platform • Lifecycle management & indication expansion • Partner product portfolio with expansion possibilities 10
Slide 12: Specialty Care – strong performance across portfolio
Specialty Care – strong performance across portfolio Product Revenues (SEK M) • Q2 Revenues SEK 796 M (716) 1,000 4,000 ▪ increase of 11 per cent (9 per cent at CER) 750 3,000 • Kineret – strong double-digit growth • Orfadin – continued strong growth 500 2,000 • Ravicti launched and gained reimburse
Slide 13: Kineret - strong growth driven by expansion of indications
Kineret - strong growth driven by expansion of indications Product Revenues (SEK M) 400 1,600 • Q2 revenues SEK 340 M (286) ▪ increase of 19 per cent (17 per cent at CER) 300 1,200 • Strong growth across all regions • Still’s indication granted EC approval on 6 April 200 800 ▪ Pricing and reimbursem
Slide 14: Orfadin – reached its highest sales level
Orfadin – reached it’s highest sales level Product Revenues (SEK M) 250 1,000 • Q2 revenues SEK 236 M (220) ▪ increase of 7 per cent (6 per cent at CER) 200 800 150 600 • Growth continued across EMENAR and North America due to solid patient support 100 400 programmes and new formulations • The first
Slide 15: Financial results
Financial results Mats-Olof Wallin 14
Slide 16: Profit & loss statement
Profit & loss statement Q2 Q2 H1 H1 Full-year Amounts in SEK M 2018 2017 2018 2017 2017 Total revenues 2,289 1,639 4,253 3,035 6,511 Total cost of goods and services sold -612 -475 -1,164 -844 -1,854 Gross profit 1,677 1,163 3,089 2,191 4,657 Gross margin 73% 71% 73% 72% 72% Sales and administrative
Slide 17: Balance sheet
Balance sheet Jun Dec Jun Jun Dec Jun Amounts in SEK M 2018 2017 2017 2018 2017 2017 Assets Equity and liabilities Intangible assets 6,240 6,445 6,643 Shareholders’ equity 7,851 6,701 5,963 Tangible and other non-current assets 328 301 270 Long-term liabilities 5 5 502 Total non-current assets 6,567
Slide 18: Pipeline
Pipeline Milan Zdravkovic 17
Slide 19: A rare disease pipeline with increasing value
A rare disease pipeline with increasing value Therapeutic area/ Indication Product/Project Pre-clinical Phase 1 Phase 2 Phase 3 Phase 4 Haemophilia A Elocta/A-SPIRE Haemophilia A Elocta/PUP A HAEMOPHILIA Haemophilia A XTEN*/BIVV001 Haemophilia A Elocta/ASURE Haemophilia A Elocta/reITIrate Haemophili
Slide 20: BIVV001 – the first, novel investigational FVIII therapy to break the VWF half-life ceiling
BIVV001 – the first, novel investigational FVIII therapy to break the VWF half-life ceiling First-in-human study • Phase 1/2a, open-label, dose-escalation, BIVV001 is a A2 multicenter study to assess the safety, Bioverativ tolerability, and FVIII activity (PK) of a programme. single dose of BIVV001
Slide 21: SOBI003 for Mucopolysaccharidosis IIIA (MPS IIIA)
SOBI003 for Mucopolysaccharidosis IIIA (MPS IIIA) Mucopolysaccharidosis IIIA (MPS IIIA) • A rare systemic disease with a significant CNS component due to incomplete breakdown and increased lysosomal storage of heparan sulfate (HS) • Increased morbidity and mortality • Caused by mutations in gene for
Slide 22: First patient screened in first-in-human study with SOBI003
First patient screened in first-in-human study with SOBI003 Development status Dose- • Orphan Drug Designation in the EU and US Dose level 3 (N=3) escalation • US FDA Fast Track Designation after 4 weeks First-in-man study Dose Level 2 (N=3) • Open-label, non-controlled, parallel, sequential ascendi
Slide 23: Enrolment completed in the phase 2 study anaGO
Enrolment completed in the phase 2 study anaGO, with anakinra in patients with acute gout Phase 2 study • A randomized, double-blind, active- 100 mg anakinra (N=53) control, multicenter, efficacy and daily s.c for 5 days Patient Population: safety study of 2 dose levels of • ≥1 flares (within subcut
Slide 24: Summary
Summary Guido Oelkers 23
Slide 25: Outlook 2018 – revised
Outlook 20181,2 – revised • Sobi expects total revenues for the full-year to be in the range of SEK 8,600 – 8,800 M (7,900 – 8,100) • Gross margin is expected to be at least 70 per cent (unchanged) • Sobi expects EBITA for the full-year to be in the range of SEK 3,400 – 3,600 M (2,800 – 3,000) 1At c
Slide 26: Our strategic direction
Our strategic direction Further internationalisation and commercialisation of Haemophilia Build Specialty Care Vision as the preferred partner To be recognised as a global leader in providing innovative Strengthen position treatments that transform lives for in the US and EMENAR individuals with rar
Slide 27: Q&A
Q&A 26
Slide 28: Slide 28
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