Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q2 2024 Earnings Presentation
32 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Jul 16, 2024
Slide 1: Q2 2024 report
Q2 2024 report Strong delivery driven by portfolio performance and achievements on development milestones Conference call for investors and analysts 16 July 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 CMO Summary and Q&A 3
Slide 4: Strategic portfolio delivering top-line growth
Strategic portfolio delivering top-line growth Continued pipeline momentum High double-digit performance at CER Sobi strategy Revenue Q2 - SEK 5,442 M, +11% (excluding sales of Doptelet in China Q2 2023 growth was 26%) Adjusted EBITA margin 28% Lead in Strategic portfolio 1 accounting for 41% of sal
Slide 5: Strong momentum delivering 11% growth in Q2
Strong momentum delivering 11% growth in Q2 Driven by launch medicines and regional growth Revenue by segment Revenue by region Q2 2024 change ratio Q2 2024 change ratio SEK M % % SEK M % % Haematology 3,866 +13 71 Europe 2,265 +13 42 North America 2,021 +38 37 – Haemophilia 2,315 +11 60 Internation
Slide 6: Strategic portfolio 41% of revenue in Q2
Strategic portfolio 41% of revenue in Q2 Q2 Q2 SEK M Change at CER H1 2024 2024 2023 Aspaveli/Empaveli 251 144 77% 490 Doptelet (excluding China) 928 567 61% 1,684 Gamifant 522 491 4% 960 Vonjo 347 36 >200% 667 Zynlonta 25 6 >200% 38 Altuviiio royalty 139 14 >200% 248 Beyfortus royalty 7 - n/a 325 S
Slide 7: Strategic portfolio strongly contributing to revenue
Strategic portfolio strongly contributing to revenue Delivering treatments to patients with greatest unmet need Portfolio segments and Revenue, MSEK • EU approval of Altuvoct % change CER contribution to growth strengthening the strategic portfolio from Q3 2024 5,442 • Royalties of Beyfortus and 4,8
Slide 8: Execution of our strategy and pipeline delivery set to drive growth
Execution of our strategy and pipeline delivery set to drive a strong growth outlook C3G / IC-MPGN sHLH / FDA filing initiated MAS SEL-212 EU approval New Indications* New medicines* Geographical expansion Beyfortus & Altuviiio (royalties) 2024 NME : New Molecular Entity. Altuvoct is marketed by San
Slide 9: Haematology: Doptelet continues to show strong momentum
Haematology: Doptelet continues to show strong momentum Doptelet +61% ex China Doptelet • US: Increased uptake driven by higher market share and duration of treatment • Europe and international ongoing growth driven by launches and increased market share • Sales growth in the quarter impacted by sal
Slide 10: Haematology: Aspaveli reaching more patients in PNH
Haematology: Aspaveli reaching more patients in PNH Phase 3 data (VALIANT study) in Nephrology expected in H2 2024 Solid Aspaveli/Empaveli launch trajectory Aspaveli/Empaveli • Strong growth momentum across EU, International and Canada as more patients switch from C5i to Aspaveli/ Empaveli seeking o
Slide 11: Haematology: Vonjo launch elements in place for growth
Haematology: Vonjo launch elements in place for growth in 2024 Vonjo SEK 347 M Highlights • Sales grew 9% (6% at CER) quarter on quarter • Continued momentum from March sales • Various external data sources indicate no volume growth in the myelofibrosis market in H1 2024 • Vonjo has achieved market
Slide 12: Our strategy on Vonjo remains unchanged
Our strategy on Vonjo remains unchanged Still, early launch insights have driven us to revise our go-to-market approach Our Strategy Potential* Status realised Untapped potential market • Take share Changes initiated in the US MF market Expect launches as of 2025; • Expand internationally Good progr
Slide 13: US approach: Building Vonjo on sound medical rationale
US approach: Building Vonjo based on a sound medical rationale and a more effective team Building on a strong scientific rationale Evolution to our approach in the US • Devastating disease impacting cytopenia’s1-3 • Changed leadership and expanded sales force • Poor Prognosis of MF patients with man
Slide 14: Haematology: Continued patient growth and geographical expansion
Haematology: Continued patient growth and geographical expansion Elocta Alprolix +14% Q2 +8% Q2 • Growth in number of patients, geographic expansion and favorable impact from phasing • Partly offset by continued price pressure in many regions Sales in SEK million at actual exchange rates; change at
Slide 15: Immunology: Gamifant continued growth in US; Kineret demand
Immunology: Gamifant continued growth in US Kineret: Increased demand across all regions Gamifant Kineret SEK 522 M Gamifant SEK 745 M +4% Q2 +11% Q2 • Growth driven by: • Increased patients from new and established centers • Higher average dosing Kineret • Beneficial impact from order phasing • Gro
Slide 16: 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 CMO Summary and Q&A 16
Slide 17: Q2 2024 Revenue and profit & loss
Q2 2024 Revenue and profit & loss Q2 Q2 Full-year Total revenue (SEK M) Amounts in SEK M 2024 2023 Change 2023 Total revenue 5,442 4,872 12% 22,123 Haematology Immunology Specialty Care Adjusted Gross profit 1,2 4,166 3,478 20% 17,162 6 844 1,2 298 6 256 Adjusted Gross margin 77% 71% 78% 272 EBITA1
Slide 18: Outlook 2024
Outlook 2024 Updated Revenue Anticipated to grow by a low double-digit percentage at CER1 Adjusted EBITA margin Anticipated to be in the mid-30s percentage of revenue 1. Constant exchange rates. 18
Slide 19: 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 CMO Summary and Q&A 19
Slide 20: Solid pipeline progress
Solid pipeline progress Altuvoct SEL-212 Haemophilia Chronic Refractory Gout EU approval in Haemophilia A FDA filing initiated Aspaveli/Empaveli Gamifant PNH sHLH / MAS in Still’s EU approval in 1-Line PNH FDA fast-track designation 20 PNH: Paroxysmal nocturnal haemoglobinuria sHLH / MAS: secondary
Slide 21: SEL-212 submission based on solid evidence
SEL-212 submission based on solid evidence sUA efficacy results from pooled pivotal data – SEL-212 vs placebo (combined DISSOLVE I+II) Primary endpoint response rate (ITT set) Serum uric acid reduction (ITT set) Statistically significant Significant reduction of sUA from higher response ratesa durin
Slide 22: New efanesoctocog alfa data in haemophilia A
New efanesoctocog alfa data underlines its potential for a paradigm shift in treating haemophilia A1,2 XTEND-ed outcomes1,2 Treatment of bleeding episodes in XTEND-ed1 Efanesoctocog alfa remains highly effective Participants from for the treatment of bleeding episodes Number of injections required t
Slide 23: Efanesoctocog alfa outcomes in joint health and surgery
Efanesoctocog alfa with excellent outcomes in joint health and perioperative management Joint health1 Major surgeries2 All target jointsa were resolvedb in participants on prophylaxis for ≥12 months Haemostatic responsed 88% of surgeries (43/49) had a Nearly all surgeries haemostatic response of exc
Slide 24: Strong rationale for Vonjo in myelofibrosis treatment
Strong rationale for Vonjo in myelofibrosis treatment Recently published data and data presented at ASCO 2024 Depth and timing of response for pacritinib 200 mg BID 1 Anaemia improvement Early increase in and sustained levels of haemoglobin1-2 Greatest benefit in patients with Consistent and most se
Slide 25: Significant events in 2024
Significant events in 2024 Anticipated major pipeline news flow Gamifant FDA Altuvoct SEL-212 FDA submission & EU approval submission Aspaveli Valiant data 2024 H1 2024 H2 Altuvoct– Haemophilia A: Gamifant – sHLH / MAS in • Regulatory approval in EU rheumatological diseases: • Regulatory submission
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) interim data Aspaveli / Empaveli – Nephrology • EU submission • Japan submission Gamifant1 – sHLH / MAS • US decision • Japan submission SEL-212 – Chronic refractory gout • US decis
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 CMO Summary and Q&A 27
Slide 28: Summary: Growth and pipeline progress
Summary: Growth and pipeline progress % growth at CER Revenue Q2 - SEK 5,442 M, +11% Second consecutive year as Significant growth member of DJSI Europe Excluding sales of Doptelet in China Q2 2023 growth was 26% Doptelet SEK 928 M, +61%, ex China Strategic portfolio Gamifant SEK 522 M, +4% contrib
Slide 29: f oa»,
f oa», Q fe) m2)
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 H2 Aspaveli/Empaveli – C3G & IC-MPGN • VALIANT phase 3 study data readout Doptelet – ITP • Regulatory submission in Japan • Paediatric submission in US & EU
Slide 31: Appendix: Q2 2024 sustainability performance
Appendix: Q2 2024 sustainability performance Sobi sustainability priorities Highlights in Q2 2024 Highlights in Q2 2024 • Milestones toward increased access • Caring for employees - European Commission approval for - Five Sobi teams across the world were ALTUVOCT® (efanesoctocog alfa) for awarded th
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
Swedish Orphan Biovitrum — Q2 2024 Earnings Presentation on 6ix