Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Sobi — Investor Presentation (February 2025)
33 slides from Swedish Orphan Biovitrum Ab's investor presentation, February 2025
Slide 1: This is Sobi
This is Sobi D Investor Presentation February 2025
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: Table of contents
Table of contents Slide Sobi Key facts and business model 4 Latest results – Q4, FY 2024 and business area update 13 Sustainability at Sobi 24 Pipeline and upcoming news flow 28 IR contacts 31 Notes 32
Slide 4: Sobi: Global biopharma company developing and commercialising rare disease therapies
Sobi: Global biopharma company developing and commercialising rare disease therapies Clear strategy with proven execution: • Source: Successful BD track record building pipeline via partnerships and acquisitions • Develop: Deep clinical-stage pipeline spanning multiple rare disease areas • Commercia
Slide 5: Rare diseases are an attractive market and expected to grow faster than general pharma
Rare diseases are an attractive market and expected to grow faster than general pharma • ~7,000 rare disease have been identified with only an Sobi well positioned within rare diseases estimated 130 with marketed treatments Current Sobi areas • High medical unmet need and treatments offering signifi
Slide 6: Business model - source, develop and commercialise in the rare disease space
Business model - source, develop and commercialise in the rare disease space 2018 2019 2020 2022 2023 Acquisitions Source Licensing Develop Driving clinical development with potential new molecules and expansion of existing medicines Europe +14% 2024: Revenue: SEK 26,027 M North America + 4% Commerc
Slide 7: Strong record of successful achievements in delivering medicines to rare disease patients
Strong record of successful achievements in delivering medicines to rare disease patients around the world Selected examples from the Sobi portfolio Source Novimmune Dova Apellis CTI Pharma ITP - FDA approval 2018 pHLH - FDA approval 2018 PNH - EU approval 2021 MF – FDA approval 2022 EU approval 202
Slide 8: Next wave of catalysts to drive growth
Develop Next wave of catalysts to drive growth Asset Indication Phase 2 Phase 3 Registration C3G and IC-MPGN Pivotal VALIANT data presented at ASN Kidney Week 2024; Aspaveli/Empaveli Filed in EU February 2025 (pegcetacoplan) Post-HSCT-associated microangiography Gamifant sHLH / MAS in FDA Fast Track
Slide 9: Strong progress in pipeline in 2024
Develop Strong progress in pipeline in 2024 Haemophilia-A: Altuvoct EU approval Aspaveli/ C3G and IC-MPGN: C3G and IC-MPGN: PNH: Empaveli Positive VALIANT phase 3 data Submission to EMA* First-line approval in EU VEXAS: Vonjo IND granted by FDA ITP: Paediatric extension Doptelet submitted to FDA ITP
Slide 10: Growth driven by core business area and all regions
Commercialise Growth driven by core business area and all regions Sales (SEK B) Sales (SEK B) Haematology Immunology Specialty Care Europe North America Royalty including Beyfortus US International 26 26 22.1 18.8 22.1 15.3 15.5 18.8 14.2 14.2 15.3 15.5 9.1 9.1 2018 2019 2020 2021 2022 2023 2024 201
Slide 11: Looking ahead to 2025
Looking ahead to 2025 Anticipated major pipeline news flow • 2025 outlook 2025 Aspaveli / Empaveli – Nephrology • EU regulatory decision Revenue • Japan regulatory submission Anticipated to grow by a high-single Gamifant1 – HLH / MAS • US regulatory decision digit percentage at CER • Japan regulator
Slide 12: Management Team
Management Team 12 sobi.com/executive committee
Slide 13: Latest results - Q4 and Full Year 2024 business area update
Latest results - Q4 and Full Year 2024 business area update
Slide 14: Strong performance of the portfolio driving growth
Strong performance of the portfolio driving growth Positive progress in regulatory and early commercial stage Top line growth of 19% in 2024 Revenue Q4: SEK 7,436 M, +8%. FY 2024: 26,027 M +19% Adjusted EBITA margin Q4: 34%, Adjusted FY 2024: 36% Strategic portfolio1 grew 50% in Q4 • Beyfortus® roya
Slide 15: Strong business growth at CER of 19% in 2024
Strong business growth at CER of 19% in 2024 Driven by existing and launch medicines and continued growth geographically Revenue by segment Revenue by region Q4 2024 change FY 2024 change contrib. FY 2024 change SEK M % SEK M % % SEK M % Haematology 4,487 +22 16,429 +24 63 Europe 9,690 +14 – Haemoph
Slide 16: Strong momentum across the portfolio in 2024
Strong momentum across the portfolio in 2024 Full Year 2024 Haematology • Haemophilia growing 11% Elocta 4 891 +1% Altuvoct 436 >200% • Doptelet: Continued strong demand across all markets Alprolix 2 372 +12% with 30% growth Altuviiio royalty 610 >200% Other Haem royalty 1 279 -10% • Aspaveli/Empave
Slide 17: Sobi's growth strategy supported by strong portfolio management
Sobi’s growth strategy supported by strong portfolio management Near-term Strategic Growth Portfolio Pipeline +48% in 2024 (34% of total revenue) • Aspaveli- C3G / IC-MPGN • Aspaveli (PNH) • Doptelet • NASP - CRG • Altuvoct • Gamifant • Gamifant - HLH/MAS • Vonjo • Zynlonta Foundation Products +6% i
Slide 18: Altuvoct: Successful first EU launch; rapid adoption in Germany
Altuvoct: Successful first EU launch; rapid adoption in Germany >15% points Haemophilia A market share gain in Germany since launch Haemophilia A sales SEK 1,440 M +9% Q4 Altuvoct Launch: • Rapid patient adoption; Fourth quarter 2024 sales of SEK 302M • Patients transitioning from Elocta and increas
Slide 19: Aspaveli: Best-in-class Phase 3 efficacy data supports global regulatory submissions in 2025
Aspaveli: Best-in-class Phase 3 efficacy data supports global regulatory submissions in 2025 Aspaveli/Empaveli SEK 269 M +44% Q4 PNH • Robust growth across markets, FY 2024 SEK 1,030 M, growth 76% at CER • Perseverance in markets with new competition Nephrology*: Filed in beginning of February in EU
Slide 20: Vonjo: Showing continued growth momentum
Vonjo: Showing continued growth momentum Vonjo SEK 416 M +27% Q4 • Performance improving: 6% quarter on quarter growth (SEK 1,462 M FY) • Committed to unlock Vonjo’s potential: I. Expand myelofibrosis treatment in line with NCCN guidelines* II. Launch in International markets • Additional markets to
Slide 21: Q4 2024 Revenue and profit & loss
Q4 2024 Revenue and profit & loss Q4 Q4 Full-year Total revenue (SEK M) Amounts in SEK M 2024 2023 Change 2024 Total revenue 7,436 6,844 9% 26,027 Haematology Immunology Specialty Care Adjusted Gross profit 1,2 5,821 5,478 6% 20,326 7 436 6 844 6 894 385 Adjusted Gross margin 1,2 78% 80% 78% 298 6 2
Slide 22: Net debt development and continued strong cash flow
Net debt development and continued strong cash flow Net Debt (M SEK) Net Debt Waterfall Sep ’24 to Dec ’24 (M SEK) 30 000 3,0 16,880 25 000 2,5 2,3 1,9 1,8 20 000 1,6 2,0 19 265 18 375 15 000 16 880 1,0 16 028 15 194 10 000 0,0 5 000 -1,0 101 9 15,194 -1,797 0 -2,0 Dec '23 Mar '24 Jun '24 Sept '24 D
Slide 23: Sobi Outlook 2025
Sobi Outlook 2025 Key considerations for 2025 2025 outlook • Altuvoct launch progress Revenue • Continued progress with commercial portfolio Anticipated to grow by a high-single • Beyfortus royalty digit percentage at CER • Launch preparation • In US for NASP in CRG • In Europe for Aspaveli in nephr
Slide 24: Sustainability at Sobi
O) @sobl Sustainability at Sobi
Slide 25: Sobi's sustainability strategy supports our strategic business priorities
Sobi’s sustainability strategy supports our strategic business priorities Maintain commitment Always act to patients responsibly Sustainability indices Index 2023 score • Access to treatment • An inclusive and diverse MSCI A (top 26%) • Patient centricity & workplace • Safe, healthy and fair Sustain
Slide 26: Maintain commitment to patients
Maintain commitment to patients For more details: Sustainability performance | Sobi Access to treatment Humanitarian aid Patient centricity • ~ 36,000 people treated* with • Four international patient councils to medicines from Sobi. advise on early clinical development. • Sobi’s main medicines acce
Slide 27: Always act responsibly
Always act responsibly For more details: Sustainability performance | Sobi Caring for employees Reduced footprint Responsible sourcing Compliance • Gender composition (%) • A 77% reduction in CO2- intensity between 2016 95% Mean score 64 95% and 2023 (from 0,3 to 0,07 between completed Code of of So
Slide 28: Pipeline and upcoming news flow
Pipeline and upcoming news flow
Slide 29: Anticipated major pipeline news flow
Anticipated major pipeline news flow Aspaveli NASP (SEL-212) Gamifant CHMP opinion Finalising US FDA decision Japan submission submission 2025 H1 2025 H2 Aspaveli – C3G & IC-MPGN: Gamifant – HLH / MAS in Still’s disease: o Regulatory submission in Japan o US regulatory decision o Japan regulatory su
Slide 30: Pipeline success in 2024
Pipeline success in 2024 Haemophilia-A: Altuvoct EU approval Aspaveli/ C3G and IC-MPGN: C3G and IC-MPGN: PNH: Empaveli Positive VALIANT phase 3 data Submission to EMA* First-line approval in EU VEXAS: Vonjo IND granted by FDA ITP: Paediatric extension Doptelet submitted to FDA ITP: submitted in Japa
Slide 31: Sobi IR contacts
Sobi IR contacts Investors page on sobi.com Gerard Tobin Jen Kretzmann Michael Greksa Head of Investor Relations Manager of Stakeholder Communication and Investor Relations North America gerard.tobin@sobi.com Corporate Access michael.greksa@sobi.com +41 79 286 28 83 jennifer.kretzmann@sobi.com +1 (7
Slide 32: Notes on Haemophilia and RSV business
Notes on Haemophilia and RSV business Haemophilia • Sobi and Sanofi collaborate on the development and commercialisation of Alprolix and Elocta/Eloctate. The companies also collaborate on the development and commercialisation of efanesoctocog alfa, or Altuviiio in the US. • Sobi has final developmen
Slide 33: Thank you
Thank you Sobi is a trademark of Swedish Orphan Biovitrum AB (publ). © 2023 Swedish Orphan Biovitrum AB (publ) – All rights reserved Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm • Sweden www.sobi.com