Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q4 2019 Earnings Presentation
30 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Feb 13, 2020
Slide 1: Q4/FY 2019 results
Q4/FY 2019 results February 13, 2020
Slide 2: 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 3: Presenters
Guido Oelkers | CEO Presenters Henrik Stenqvist | CFO Milan Zdravkovic | Head of R&D and CMO 3
Slide 4: Creating a rare disease leader
Creating a rare disease leader Grow within Haematology ➢ Transformation into broader Haematology franchise Over the past year we have continued to successfully Develop Immunology ➢ First launch success with Gamifant, execute on our strategy to solid growth of Synagis diversify from Haemophilia into
Slide 5: 2019: A year of transformation and strong growth
2019: A year of transformation and strong growth • Financial performance: Strong organic top-line and earnings growth +20% CER - Sales (+56% YoY) and adj. EBITA (+72% YoY) organic growth Continued • Haemophilia: Continued double-digit growth strong growth - Elocta (+34% CER YoY) & Alprolix (+46% CER
Slide 6: Extraordinary performance: Double-digit growth and margin expansion
Extraordinary performance: Double-digit growth and margin expansion Total revenue SEK M 43% 21 000 39% 18 000 32% +48% CER 15 000 30% 1 787 12 000 4 706 9 000 1 805 13% 1 322 6 000 1 687 1 694 1 142 7 755 3 000 1 666 1 001 6 012 3 682 805 2 509 0 756 2015 2016 2017 2018 2019 EBITA Adj. Margin Specia
Slide 7: Recent acquisition strategy has led to a stronger, more diversified pipeline
Recent acquisition strategy has led to a stronger, more diversified pipeline… Haematology Immunology Specialty Care Avatrombopag1 CIT ITP CLD Emapalumab4 Secondary HLH New indications Indication Pipeline Anakinra5 expansion BIVV0012 Haemophilia A Nirsevimab6 Phase 3 BIVV0023 Haemophilia B NI-1701/18
Slide 8: A clear strategic focus for mid-term growth
…with a clear strategic focus for mid-term growth Strategic priorities Haemophilia A (rFVIIIFc) Best-in-class Maintain EHL products 1 Maintain haemophilia leadership Haemophilia B Innovate (rFIXFc) BIVV001 Haematology Diversify CIT 2 Build Doptelet to scale ITP Build CLD sHLH – sJIA (MAS) 3 Extend G
Slide 9: Haematology
Haematology 9
Slide 10: Haematology: Reaching sales over SEK 2 bn in the quarter
Haematology: Reaching sales over SEK 2 bn in the quarter Sales (SEK M) • Q4 revenue of SEK 2,142 M (1,752) 2 400 - Revenue growth of 22 per cent (18 per cent at CER) 2 000 - SEK 1,673 M (1,248) in product sales 1 600 - SEK 352 M (367) in royalty revenue - SEK 116 M (137) in manufacturing revenue 1 2
Slide 11: Elocta: Continued strong double-digit growth
Elocta: Continued strong double-digit growth Sales (SEK M) 1 500 6 000 • Q4 product sales of SEK 1,235 M (945) ▪ Sales growth of 31 per cent (26 per cent at CER) 1 200 4 800 ▪ Majority of the growth derived from France, Germany, Italy and the Middle East 900 3 600 • FY product sales of SEK 4,508 M (
Slide 12: Haemophilia today: What did we learn from EAHAD?
Haemophilia today: What did we learn from EAHAD? Conviction amongst many KOLs: “Factor replacement remains the standard of care in patients with haemophilia A” “Inhibitor prevention/eradication is important to ensure better bleed control in all clinical scenarios, even in this new therapeutic era” “
Slide 13: Doptelet: Current and future opportunities
Doptelet: Current and future opportunities CLD ITP CIT Launch ongoing in the US Launch ongoing in the US Orphan Drug designation by the FDA Regulatory Expected launch in the EU Submission in the EU H1 2020 in December 2019 milestones H2 2020 Phase 3 top-line read-out H2 2020 US market potential esti
Slide 14: Immunology
Immunology 14
Slide 15: Immunology: Strong overall growth across the franchise
Immunology: Strong overall growth across the franchise Sales (SEK M) 2 500 • Total Immunology revenue for the quarter was SEK 2,233 M (335 M) 2 000 • FY revenues were SEK 4,706 M (1,320 M) 1 500 • Growth driven by all three products within the portfolio - Synagis sales were better than expected due
Slide 16: Synagis: Very strong Q4 sales
Synagis: Very strong Q4 sales – Synagis is performing well under our ownership Sales (SEK M) • Synagis sales for the quarter were SEK 1,656 M 1 800 • FY revenue of Synagis were SEK 2,594 M 1 500 • Very strong Q4 sales mainly due to: 1 200 - Overall increased demand/referrals as a result of 900 impro
Slide 17: Gamifant: Strong Q4 sales
Gamifant: Strong Q4 sales • Gamifant sales for the quarter amounted to SEK 180 M. Sales (SEK M) FY 2019 Gamifant sales were SEK 542 M. 250 • Strong sales reflect a demand increase and increasing experience with the product’s benefits 200 • Consumption by patient also increased due to average 150 dos
Slide 18: Pipeline
Pipeline 18
Slide 19: Significantly strengthened and diversified pipeline
Significantly strengthened and diversified pipeline Phase 1 Phase 2 Phase 3 Registration NI-1701 Gamifant/emapalumab BIVV001/ Gamifant/emapalumab Anti-CD47/CD191 Secondary HLH/MAS rFVIIIFc-vWF-XTEN2 Primary HLH (EU) B cell lymphoma children Haemophilia A SUBMITTED Kineret/anakinra Gamifant/emapaluma
Slide 20: And with a significant near-term news flow
…And with a significant near-term news flow Compound Indication/Expected Milestone Event Status Phase 3 study in adults and adolescents (≥12 years) Initiated BIVV001 Expect to be initiated by year-end Phase 3 study in children (< 12 years) 2020 Haematology Approved in the US Chronic immune thrombocy
Slide 21: BIVV001: Registration study initiated
BIVV0011: Registration study initiated Phase 3 study in previously treated patients ⩾ 12 years (n=150) Prior FVIII • Primary endpoint: Annualised bleeding rate regimen Arm A • Novel endpoints include joint health via Weekly prophylaxis Prophylaxis ultrasound and physical activity monitoring (n=124)
Slide 22: Financial results
Financial results 22
Slide 23: Financial results
Financial results Total revenue (SEK M) Q4 Q4 Full-year Full-year 5 000 Amounts in SEK M 2019 2018 Change 2019 2018 Change Total revenue 4,890 2,571 90% 14,248 9,139 56% 4 000 Gross profit 3,833 1,894 102% 10,913 6,723 62% Gross margin1 78% 74% 77% 74% 3 000 EBITA adjusted1,2 2,380 916 160% 6,145 3,
Slide 24: Revenue and opex development – diversifying into new areas of growth
Revenue and opex1 development – diversifying into new areas of growth Synagis, Gamifant & Doptelet Revenue (SEK M) Base • Opex spend on base business2 is stable 4.9 with increased investments driven by 3.3 3.2 38% Haemophilia 2,6 2.9 2,0 2,3 2,3 62% • Increase in Opex coming from 38% acquisitions3 –
Slide 25: Historical operating cash flow and net debt
Historical operating cash flow and net debt Operating Cash Flow Development (M SEK) 1 400 100% • Acquisition of Dova in Q4 19 1 200 80% 1 000 65% 68% 61% • Q4 19 Net debt increase to SEK 15.4B (vs. Q3 19 of SEK 7.6B) 58% 58% 800 52% 55% 50% 60% - Q3 19 Net debt / EBITDA < 1.5x - Q4 19 Net debt / EBI
Slide 26: Financial outlook
Financial outlook 26
Slide 27: Further investment in 2020 will lay the foundation for future growth
Further investment in 2020 will lay the foundation for future growth… Haematology • Doptelet and Gamifant – future growth drivers - Investment into market penetration and clinical trials with a view to expand indications for both products will affect our results in 2020 - Doptelet and Gamifant have
Slide 28: Financial outlook 2020
Financial outlook 2020 Revenue for the full-year 2020 is expected to be in the range of SEK 15,000 – 16,000 M reflecting double-digit growth in the two core businesses, Haematology and Immunology. EBITA is expected to be in the range of SEK 5,500-6,300 M, including the development and launch of Dopt
Slide 29: Q&A
Q&A 29
Slide 30: Sobi is a trademark of Swedish Orphan Biovitrum AB (publ)
Sobi is a trademark of Swedish Orphan Biovitrum AB (publ). © 2020 Swedish Orphan Biovitrum AB (publ) – All rights reserved Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm • Sweden www.sobi.com
Swedish Orphan Biovitrum AB (Sobi) — Q4 2019 Earnings Presentation on 6ix