Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q3 2024 Earnings Presentation
32 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Oct 24, 2024
Slide 1: Q3 2024 report: Strong growth and significant pipeline momentum
Q3 2024 report Strong growth and significant pipeline momentum Conference call for investors and analysts 24 October 2024
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains certain forward-looking statements with respect to certain of the Company’s current expectations and projections about future events. These statements, which sometimes use words such as “intend,” “proposed,” “plan,” “expect,” and words of similar
Slide 3: Agenda
Agenda Business update Guido Oelkers, Chief Executive Officer Financials Henrik Stenqvist, Chief Financial Officer R&D Pipeline Lydia Abad-Franch, Head of R&D and Chief Medical Officer Summary and Q&A 3
Slide 4: Demand growth in strategic portfolio in Q3 2024
Demand growth in strategic portfolio in Q3 2024 Positive progress in clinical development milestones High double-digit performance at CER Revenue Q3 - SEK 6,894 M, +39% (excluding RSV revenue grew 16%) Adjusted EBITA margin 43% Sobi Strategy Strategic portfolio 1 grew 113% in Q3 • Beyfortus® royalti
Slide 5: Robust growth across business areas and regions
Robust growth across business areas and regions YTD growth 24% driven by new approvals and momentum of launches Revenue by segment Revenue by region Q3 2024 change ratio Q3 2024 change ratio SEK M % % SEK M % % Haematology 4,000 +18 58 Europe 2,319 +14 33 North America 1,969 +15 29 – Haemophilia 2,2
Slide 6: Strategic portfolio – 56% of revenue in Q3
Strategic portfolio – 56% of revenue in Q3 Q3 Q3 Jan-Sep SEK M Change at CER 2024 2023 2024 Altuvoct 129 n/a n/a 134 Aspaveli/Empaveli 270 169 66% 760 Doptelet* 987 650 57% 2,671 Gamifant 405 438 -3% 1,365 Vonjo 379 347 13% 1,046 Zynlonta 29 15 96% 68 Altuviiio royalty 152 42 >200% 400 Beyfortus roy
Slide 7: Growth portfolio and pipeline progression
Growth portfolio and pipeline progression Pipeline* On market portfolio Altuviiio Beyfortus royalty royalty sHLH/MAS US FDA Fast Track 3 important products/indications short-term milestones achieved Designation SEL-212 100% YTD growth YTD Growth CRG Filed US FDA under Fast Track Designation C3G/IC-M
Slide 8: Altuvoct already showing rapid adoption in Germany
Altuvoct already showing rapid adoption in Germany Sobi Haemophilia A market share increasing by more than 6% Altuvoct Launch • Rapid patient adoption in Germany with sales of SEK 129 M • Patients coming from Elocta and competitive treatments (including non-factor products) • Sobi Market Share (Eloc
Slide 9: Aspaveli PNH & Nephrology - Positive Phase 3 results in rare kidney diseases
Aspaveli PNH & Nephrology - Positive Phase 3 results in rare kidney diseases Solid Aspaveli/Empaveli SEK 270 M PNH +66% Q3 • Continued strong growth momentum across EU, International and Canada as more patients switch to Aspaveli / Empaveli seeking improved control of their PNH • Q3 SEK 270 M (+66%
Slide 10: Sobi's view on pegcetacoplan in C3G – IC-MPGN
Sobi’s view on pegcetacoplan in C3G – IC-MPGN We are confident in pegcetacoplan’s blockbuster potential #1 We remain confident in a diagnosed patient population of at least 8k patients with C3G or IC-MPGN in Europe Additional potential opportunity in Japan and selected international markets #2 Incre
Slide 11: Doptelet continues to show strong momentum across all regions
Doptelet continues to show strong momentum across all regions Doptelet SEK 1,039 M +65% Q3 • Continued strong momentum in the business driven by increase market share gains in all regions • Doptelet delivers a favorable product profile with proven efficacy, convivence and favorable tolerability • Mi
Slide 12: Vonjo showing continued growth momentum
Vonjo showing continued growth momentum Vonjo SEK 379 M +13% Q3 • 12% quarter on quarter growth (13% YoY) • Field activity level significantly increased • Product awareness increased to >70%1 • Our long-term growth strategy is to tap into the potential related to: • New indications • International m
Slide 13: Elocta & Alprolix: Continued patient growth and geographical expansion
Elocta & Alprolix :Continued patient growth and geographical expansion Elocta Alprolix SEK 1,119 M Elocta SEK 575 M -9% Q3 • Sales impacted by order phasing in +8% Q3 International and Altuvoct launch in Germany Alprolix • Growth in number of patients, geographic expansion • Partly offset by continu
Slide 14: Gamifant set to complete filing in sHLH/MAS by year-end; Kineret growth
Gamifant set to complete filing in sHLH/MAS by year-end Kineret: Continued solid growth, + 21% in Q3 Gamifant Kineret SEK 405 M Gamifant SEK 699 M -3% Q3 • 1,000th patient treated +21% Q3 • Positive patient volumes • Q3 impacted by destocking / variation in patient treatment Kineret • Growth in all
Slide 15: Agenda
Agenda Business update Guido Oelkers, Chief Executive Officer Financials Henrik Stenqvist, Chief Financial Officer R&D Pipeline Lydia Abad-Franch, Head of R&D and Chief Medical Officer Summary and Q&A 15
Slide 16: Q3 2024 Revenue and profit & loss
Q3 2024 Revenue and profit & loss Q3 Q3 Full-year Total revenue (SEK M) Amounts in SEK M 2024 2023 Change 2023 Total revenue 6,894 5,168 33% 22,123 Haematology Immunology Specialty Care Adjusted Gross profit 1,2 5,604 4,033 39% 17,162 6 844 6 894 1,2 298 311 Adjusted Gross margin 81% 78% 78% 6 256 2
Slide 17: Outlook 2024
Outlook 2024 Updated Revenue Anticipated to grow by a mid-teen percentage at CER1 Adjusted EBITA margin Anticipated to be in the mid-30s percentage of revenue 1. Constant exchange rates. 17
Slide 18: Agenda
Agenda Business update Guido Oelkers, Chief Executive Officer Financials Henrik Stenqvist, Chief Financial Officer R&D Pipeline Lydia Abad-Franch, Head of R&D and Chief Medical Officer Summary and Q&A 18
Slide 19: Solid pipeline progress
Solid pipeline progress Altuvoct SEL-212 Haemophilia Chronic Refractory Gout NEJM XTEND-kids FDA filing on track Aspaveli/Empaveli Doptelet C3G and IC-MPGN ITP Positive VALIANT Phase 3 data Paediatric filing in US enFuse® injector Filing in Japan Collaboration with Enable Injections, Inc. C3G and IC
Slide 20: Pegcetacoplan: Positive VALIANT Phase 3 study
Pegcetacoplan: Positive VALIANT Phase 3 study Statistically significant reduction in proteinuria in a broad study population • Positive effects consistent across subgroups 68% (p<0.0001) relative reduction in proteinuria vs placebo at Week 26 • C3G and IC-MPGN • Adolescent and adult • Native kidney
Slide 21: Pegcetacoplan: Device partnership with Enable Injections, Inc.
Pegcetacoplan: Device partnership with Enable Injections, Inc. • enFuse® Injector for subcutaneous delivery of pegcetacoplan • Goals: enhance patient experience, support adherence, expand choice • International development and distribution agreement across Sobi territories • Aim to be available in E
Slide 22: Emapalumab research collaboration on CAR-T toxicities
Emapalumab research collaboration on CAR-T toxicities Hyperinflammation is a common side effect of CAR-T therapy2,4,10 Emapalumab could help mitigate CAR-T side effects Cytokine release syndrome (CRS)onset occurs within hours to 14 days after CAR-T infusion and persists for up to 10 days1,2,5,6 Inte
Slide 23: Pacritinib's potential beyond myelofibrosis
Pacritinib’s potential beyond myelofibrosis Emerging areas of interest Characteristics Current treatment options Rationale for pacritinib Sobi supported ISS First described in 2020 No standard treatment or Pacritinib’s unique kinome Pacritinib in Vacuoles, E1 approved therapies profile may further t
Slide 24: Altuvoct: Building further evidence
Altuvoct: Building further evidence 1 Focus on joint health and physical activity of patients had zero bleeding 64% episodes (47/74) Just one bleed can trigger a vicious cycle of repeat bleeding which leads to arthropathy 2 of patients had zero joint bleeds 82% (61/74) FREEDOM Phase 3b study (NCT058
Slide 25: Significant events in 2024
Significant events in 2024 Anticipated major pipeline news flow SEL-212 Altuvoct Aspaveli Gamifant FDA filing EU approval VALIANT data FDA filing ongoing 2024 H1 2024 H2 Altuvoct– Haemophilia A: Doptelet – ITP: Regulatory approval in EU Regulatory submission in Japan Paediatric submission in US Paed
Slide 26: Continued R&D momentum in 2025
Continued R&D momentum in 2025 Anticipated major pipeline news flow 2025 Altuvoct – Haemophilia A • FREEDOM (Phase 3b) initial study data Aspaveli / Empaveli – Nephrology • EU submission • Japan submission Gamifant1 – sHLH / MAS • US decision • Japan submission SEL-212 – Chronic refractory gout • US
Slide 27: Agenda
Agenda Business update Guido Oelkers, Chief Executive Officer Financials Henrik Stenqvist, Chief Financial Officer R&D Pipeline Lydia Abad-Franch, Head of R&D and Chief Medical Officer Summary and Q&A 27
Slide 28: Summary: Growth and pipeline progress
Summary: Growth and pipeline progress % growth at CER Revenue Q3 - SEK 6,894 M, +39% Second consecutive year as Significant growth member of DJSI Europe Strong Beyfortus royalty contribution, excluding RSV portfolio grew 16% Doptelet* SEK 1,039 M, +65% Strategic portfolio Aspaveli/Empaveli SEK 270
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Slide 30: Current development pipeline
Current development pipeline Major ongoing clinical studies and medicines in registration in a major region or country Pipeline news flow 2024 Q4 Gamifant – sHLH / MAS in rheumatological diseases • Regulatory submission in the US (Still’s disease cohort) Doptelet – ITP • Paediatric submission in the
Slide 31: Appendix: Q3 2024 sustainability performance
Appendix: Q3 2024 sustainability performance Sobi sustainability priorities Highlights in Q3 2024 Highlights in Q3 2024 • Milestones toward increased • Caring for employees access - In the wake of Hurricane Helene, - Publication in NEJM* of full results Sobi provided assistance to from Phase 3 XTEND
Slide 32: Thank you
CONFIDENTIAL – FOR INTERNAL USE ONLY Thank you Sobi is a trademark of Swedish Orphan Biovitrum AB (publ). © Swedish Orphan Biovitrum AB (publ) – All rights reserved Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm • Sweden www.sobi.com
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