Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q3 2018 Earnings Presentation
32 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Oct 31, 2018
Slide 1: Q3 2018 Results
Q3 2018 Results 31 October 2018
Slide 2: Agenda and Presenters
AGENDA PRESENTERS Guido Oelkers Introduction Chief Executive Officer and President Business review Emapalumab Financials Henrik Stenqvist Summary Chief Financial Officer Armin Reininger Head of Medical & Scientific Affairs 1
Slide 3: Forward looking statements
Forward looking statements In order to utilise 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: Q3 highlights
Q3 highlights • Total revenues of SEK 2,315 M (1,601) in Q3 and SEK 6,568 M (4,636) YTD • 45 per cent sales growth in the quarter compared with Q3 2017 (34 per cent at constant exchange rates (CER)) • EBITA increased by 74 per cent to SEK 933 M (536) in Q3 and 85 per cent to SEK 2,655 M (1,434) YTD
Slide 5: Business review Q3
Business review Q3 Guido Oelkers 4
Slide 6: Haemophilia - capitalise on strong position and substantial potential
Haemophilia - capitalise on strong position and substantial potential Drive Haemophilia commercial Expand access to patients in markets where treatment not yet available effectiveness and Reimbursement for Alprolix gained in Sweden and Slovakia international- isation Portfolio with the most exte
Slide 7: Elocta and Alprolix – enable people with haemophilia to live well
Elocta and Alprolix – enable people with haemophila to live well • Well established safety and efficacy profiles - real-world experience from thousands of patients • Replacing the missing factor – fundamental in haemophilia treatment • Standard of care in many countries • Suitability for all patient
Slide 8: Haemophilia – over SEK 1.5 Bn in revenues in Q3
Haemophilia – over SEK 1.5 Bn in revenues in Q3 Total Revenues (SEK M) 1 800 • Q3 revenues of SEK 1,545 M (948) 1 600 • Revenue growth of 63 per cent (52 per cent 1 400 increase at CER) 1 200 1 000 800 SEK 1,128 M (515) in product revenues 600 SEK 338 M (298) in royalty revenues 400 SEK 79 M (
Slide 9: Elocta – increasingly becoming the standard of care
Elocta – increasingly becoming the standard of care Sales Revenues (SEK M) 1 000 • Q3 product revenues of SEK 873 M1 (417) 900 Revenue growth of 110 per cent 800 (93 per cent at CER) 700 EU5 markets accounted for 76 per cent of 600 the growth 500 400 300 • Reimbursed in 25 countries 200 100 1 Re
Slide 10: Alprolix – continued strong patient conversion
Alprolix – continued strong patient conversion Sales Revenues (SEK M) 300 • Q3 product revenues of SEK 255 M (98) 250 Revenue growth of 161 per cent (140 per cent at CER) 200 77 per cent of the growth derived from France, Germany, Italy and the UK 150 100 • Reimbursed in 18 countries 50 0 Q1 Q2
Slide 11: Specialty Care - Acquisitions to further drive growth
Specialty Care - Acquisitions to further drive growth Develop World-class commercialisation platform Specialty Care Launches for Ravicti and Kineret for the treatment of Still’s disease continued during the quarter Expand Active strategic partnership management in order to continuously introduce n
Slide 12: Specialty Care - solid performance across portfolio
Specialty Care - solid performance across portfolio Sales Revenues (SEK M) 1 000 4 000 • Q3 revenues SEK 770 M (653) • Revenue growth of 18 per cent 750 3 000 (8 per cent at CER) 500 2 000 250 1 000 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2016 2017 2018 Quarterly 4Q-rolling 11 Swedish Orphan Biovitrum
Slide 13: Kineret – new indications drive growth
Kineret – new indications drive growth Sales Revenues (SEK M) 400 1 600 • Q3 revenues SEK 347 M (272) Revenue growth of 28 per cent (17 per cent at CER) 300 1 200 • Continued solid growth across NA and EMENAR 200 800 • Stable double-digit growth across EU5 and Turkey 100 400 • Commercial launch fo
Slide 14: Orfadin – continued solid performance
Orfadin – continued solid performance Sales Revenues (SEK M) 250 1 000 • Q3 revenues SEK 217 M (202) Revenue growth of 8 per cent 200 800 (decrease of -2 per cent at CER) 150 600 • The first generics have entered the market, 100 400 however the impact was not material 50 200 0 0 Q1 Q2 Q3 Q4 Q1 Q2
Slide 15: Emapalumab – a strategic deal
Emapalumab – a strategic deal 14
Slide 16: Sobi licenses emapalumab from Novimmune
Sobi licenses emapalumab from Novimmune • Progress toward becoming a global leader in rare diseases • Builds Specialty Care and strengthens immunology focus • Increases US footprint • Bolsters R&D pipeline • Emapalumab in review for rare disease primary haemophagocytic lymphohistiocytosis (HLH) • FD
Slide 17: Emapalumab – a product that is right on our strategic focus
Emapalumab – a product that is right on our strategic focus Strengthen pipeline and build foundation for self-sustained R&D Expand US business and extend leading position in EMENAR Develop Drive Haemophilia commercial Specialty Care effectiveness and internationalisation Sustainable short- and l
Slide 18: Emapalumab
Emapalumab Fully human monoclonal antibody that targets IFN- gamma, a central mediator of inflammation • Strategic partnership to develop and commercialise emapalumab, a highly attractive late stage orphan drug candidate that addresses a high unmet medical need in Haemophagocytic lymphohistiocytosis
Slide 19: Haemophagocytic lymphohistiocytosis (HLH)
Haemophagocytic lymphohistiocytosis (HLH) Two patient segments HLH is a rare and life-threatening syndrome of extreme immune activation Primary HLH (pHLH) Secondary HLH (sHLH) genetic disease to infections, autoimmune diseases or malignancy Initial filing High unmet medical need • Fatal with median
Slide 20: The transaction is an excellent fit with our strategy
The transaction is an excellent fit with our strategy Late stage orphan drug, in the area of inflammation, addressing a high unmet medical need Develop Specialty Care Provides an attractive near-term commercial opportunity with USD 300 M peak sales potential Expected to support sustainable sal
Slide 21: Emapalumab will be a catalyst for creating a strong Immunology franchise
Emapalumab will be a catalyst for creating a strong Immunology franchise in Specialty Care Haemophilia Specialty Care Immunology GenMet/ Other Emapalumab 20 Swedish Orphan Biovitrum AB (Publ) (SobiTM)
Slide 22: Pipeline October 2018 – continuous expansion of possible indications
Pipeline October 2018 – continuous expansion of possible indications Interim data published in Haemophilia show Therapeutic area / Indication Product / Project Pre-clinical Phase 1 Phase 2 Phase 3 Phase 4 improvements in long-term joint health for haemophilia A patients after prophylactic Haemophili
Slide 23: Financial results
Financial results Henrik Stenqvist 22
Slide 24: Financial highlights Q3 2018
Financial highlights Q3 2018 Total Revenue (SEK M) Q3 Q3 Change Jan- Jan- Change 2 500 2018 2017 (%) Sep Sep (%) 2018 2017 2 000 Revenues 2,315 1,601 +45 6,568 4,636 +42 (SEK M) 1 500 Gross margin 75% 70% 74% 72% 1 000 EBITA (SEK M) 933 536 +74 2,655 1,434 +85 500 EBITA margin 40% 33% 40% 31% 0 Q1 Q
Slide 25: Profit & loss statement
Profit & loss statement Q3 Q3 Jan-Sep Jan-Sep Full-year Amounts in SEK M 2018 2017 2018 2017 2017 Total revenues 2,315 1,601 6,568 4,636 6,511 Total cost of goods and services sold -574 -473 -1,738 -1,316 -1,854 Gross profit 1,741 1,129 4,830 3,320 4,657 Gross margin 75% 70% 74% 72% 72% Sales and ad
Slide 26: Balance sheet
Balance sheet Sep Dec Sep Sep Dec Sep Amounts in SEK M 2018 2017 2017 2018 2017 2017 Assets Equity and liabilities Intangible assets 10,242 6,445 6,535 Shareholders’ equity 8,499 6,701 6,352 Tangible and financial assets 362 301 277 Total non-current assets 10,604 6,746 6,812 Long-term liabilities 4
Slide 27: Summary
Summary Guido Oelkers 26
Slide 28: Strategic direction
Strategic direction Strengthen pipeline and build foundation for self-sustained R&D Expand US business and extend leading position in EMENAR Develop Drive Haemophilia Specialty Care commercial effectiveness and internationalisation 27
Slide 29: Strong growth and positive outlook in the rare disease market segment
Strong growth and positive outlook in the rare disease market segment HAEMOPHILIA SPECIALTY CARE LONG TERM VALUE CREATION Strong product offering Move towards proprietary drugs and drug candidates Continued market expansion Profitable growth High entry barriers limit Acquisitions to competition - Le
Slide 30: Outlook 2018 - revised
Outlook 2018 - revised • Sobi expects total revenues for the full year to be in the range of SEK 8,900 - 9,000 M (8,600 - 8,800) • The gross margin is expected to be in the range of 73 - 74 per cent (at least 70) • Sobi expects EBITA for the full year to be in the range of SEK 3,400 - 3,500 M (3,400
Slide 31: @sobi
30 @sobi
Slide 32: Sobi – Pioneer in Rare Diseases
Swedish Orphan Biovitrum AB (Sobi) — Q3 2018 Earnings Presentation on 6ix