Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Sobi — J.P. Morgan 2023 Healthcare Conference
26 slides from Swedish Orphan Biovitrum Ab's conference presentation, Jan 11, 2023
Slide 1: Sobi J.P. Morgan 2023 Healthcare Conference
Sobi J.P. Morgan 2023 Healthcare Conference 11 January 2023
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) (Sobi®) is providing the following cautionary statement: This presentation contains forward-looking statements with re
Slide 3: Agenda
Agenda Overview Guido Oelkers, Chief Executive Officer Current performance Pipeline Q&A 3
Slide 4: Sobi at a glance
Sobi at a glance Specialised international biopharmaceutical company Providing reliable access to innovative medicines In the areas of haematology, immunology and specialty care Own presence in around 30 countries, delivering treatments to patients in many more Around 1,600 employees Global head off
Slide 5: Strategic business priorities
Strategic business priorities Lead in Haematology Grow Capture the Immunology value of the and pipeline Speciality Care Go global 5
Slide 6: Building for the future through licensing and acquisitions
Building for the future through licensing and acquisitions 2018 2019 2020 2021 2022 Novimmune Dova Gamifant® – Doptelet® – immune haemophagocytic thrombocytopenia Ionis (Akcea) ADC Therapeutics lymphohistiocytosis (ITP) and chronic Tegsedi® – Zynlonta® – relapsed or (HLH) liver disease (CLD) polyneu
Slide 7: Agenda
Agenda Overview Current performance Guido Oelkers, Chief Executive Officer Pipeline Q&A 7
Slide 8: Q3 2022: sustained progress
-6% Q3 2022: sustained progress Q3 2022 revenue • Revenue -6% in Q3 due to high base; +9% YTD, fully underpinning 2022 outlook • Commercial execution with launch medicines1 +22% in Q3 Haemophilia continued relative stability, strong Doptelet, Aspaveli launch progressed; Immunology had a large elemen
Slide 9: Business: growth driven by Doptelet in Haematology and by Europe
Business: growth driven by Doptelet in Haematology and by Europe Q3 ’22 change ratio YTD’22 change ratio Q3 ’22 change ratio YTD’22 change ratio SEK M % % SEK M % % SEK M % % SEK M % % Haematology 2,619 3 65 7,806 14 61 Europe 1,912 3 48 5,608 4 44 – Haemophilia 1,882 -3 47 5,610 2 44 North America
Slide 10: Haematology: haemophilia continued relative stability
Haematology: haemophilia continued relative stability Elocta® Haemophilia expected to Alprolix® -5% Q3 | +5% YTD continue stability in 2022 +2% Q3 | +0% YTD Elocta • Growth in patients and factor consumption offset by price and retrospective clawbacks Alprolix • Growth in patients reduced by unfavou
Slide 11: Haematology: Doptelet up 77% in Q3 excluding sales to the partner in China
Haematology: Doptelet up 77% in Q3 excluding sales to the partner in China Doptelet +12% Q3 | +85% YTD • US performance from new patients, new prescribers, higher market share and longer duration of treatment • Europe saw strong growth from Germany and recent country reimbursements • China sales SEK
Slide 12: Aspaveli launch in Europe for PNH
Launching in the UK, Germany, France and the Middle East SEK now launching in 49 M Europe for PNH1 in Q3 2022 sales c. 65 patients on commercial supply 1. In the EU and the UK, Aspaveli is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic a
Slide 13: Immunology: Kineret COVID-19 reset; Gamifant soft quarter
Immunology: Kineret COVID-19 reset; Gamifant soft quarter Kineret Gamifant -10% Q3 | -4% YTD -36% Q3 | +0% YTD Kineret • No COVID-19 sales reduced growth coming from other indications Gamifant • Unfavourable patient mix, i.e. lower share of heavier patients, and fewer new patients Sales in SEK milli
Slide 14: Immunology: later Synagis start than in 2021
Immunology: later Synagis start than in 2021 Synagis -30% Q3 | +12% YTD • Later start to the 2022-2023 RSV1 season compared to 2021 • US RSV infections have continued to increase • Sobi continues to anticipate a 2022-2023 season that will follow a pattern closer to a normal season than in 2021 Sales
Slide 15: Revenue, profit & loss
Revenue, profit & loss Haematology Immunology Specialty Care Q3 Q3 Full-year 2022 2021 Change 2021 4,896 4,925 Total revenue 3,999 3,761 6% 15,529 324 307 Gross profit 3,067 2,802 9% 12,045 3,876 3,999 3,761 310 341 Gross margin1 77% 75% 78% 326 2,119 2,330 847 1,070 EBITA1 1,241 1,166 6% 5,575 1,14
Slide 16: 2022 outlook
2022 outlook Revenue Anticipated to grow by a mid to high single-digit percentage at CER1, potentially towards the higher end of the range EBITA margin adjusted2 Anticipated to be at a low 30s percentage of revenue, including the cost effects of the agreement to license the new medicine loncastuxima
Slide 17: Agenda
Agenda Overview Current performance Pipeline Guido Oelkers, Chief Executive Officer Q&A 17
Slide 18: Key Development programmes
Key Development programmes Source: https://www.sobi.com/en/pipeline. 18
Slide 19: Pipeline: significant progress on key milestones in Q3 2022
Pipeline: significant progress on key milestones in Q3 2022 Major pipeline milestones since the previous quarterly report Significant regulatory submission acceptance efanesoctocog milestones haemophilia A and granting of priority review in the alfa US (by Sanofi) Aspaveli/ CASCADE phase 3 study fir
Slide 20: Pipeline: Q3 regulatory and scientific highlights
Pipeline: Q3 regulatory and scientific highlights loncastuximab tesirine Gamifant CHMP positive opinion Data presentation at SOHO3 Data presentation at PReS4 • Positive EU CHMP1 opinion for • Initial data from 20-patients’ • Long-term follow up study on the treatment of R/R DLBCL2 safety run-in of L
Slide 21: Pipeline news flow
Pipeline news flow Anticipated major upcoming pipeline news flow Q4 2022 H1 2023 H2 2023 loncastuximab tesirine – DLBCL: regulatory decision (EU) ✓ efanesoctocog alfa – haemophilia A: regulatory decision (US) efanesoctocog alfa – haemophilia A: regulatory submission (EU) Kineret – COVID-19: regulato
Slide 22: Agenda
Agenda Overview Current performance Pipeline Q&A Guido Oelkers, Chief Executive Officer 22
Slide 23: Sobi
~ sobi 23
Slide 24: Appendix: Q3 2022 sustainability performance
Appendix: Q3 2022 sustainability performance Commitment Responsible to patients behaviour Highlights in Q3 2022 Our R&D is ethical and We help our people • Milestones toward increased access • Hurricane Ian proactive outreach focused on medical need develop and keep them - Exclusive licensing agreem
Slide 25: Appendix: items affecting comparability (IAC)
Appendix: items affecting comparability (IAC) Source: Sobi Q3 2022 report, page 3. 25
Slide 26: Sobi rare strength
@sobl rare strength