Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q1 2024 Earnings Presentation
31 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Apr 25, 2024
Slide 1: Q1 2024 report
Q1 2024 report Strong sales reflecting the strength of the portfolio Conference call for investors and analysts 25 April 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 in all regions
Strategic portfolio delivering top-line growth in all regions Sobi strategy High double-digit performance at CER Revenue Q1 - SEK 6,256 M, +20% Lead in EBITA margin adjusted 37% Haematology Strategic portfolio1 accounting for 35% of sales in Q1 (15% Q1 2023) • Vonjo® (SEK 320 M) • Continued strong g
Slide 5: Business growth at CER of 20% in Q1
Business growth at CER of 20% in Q1 Growth driven by launch medicines and geographical expansion Revenue by segment Revenue by region Q1 2024 change ratio Q1 2024 change ratio SEK M % % SEK M % % Haematology 4,075 +46 65 Europe 2,487 +15 40 – Haemophilia 2,746 +23 44 North America 2,244 -3 36 Immuno
Slide 6: Strategic portfolio accounting for 35% of revenue in Q1
Strategic portfolio accounting for 35% of revenue in Q1 Q1 Q1 SEK M Change at CER FY 2023 2024 2023 Aspaveli/Empaveli 240 95 155% 594 Doptelet (excluding China) 756 475 59% 2,420 Gamifant 438 219 100% 1,645 Vonjo 320 - n/a 706 Zynlonta 13 3 >200% 33 Altuviiio royalty 108 1 6% 145 Beyfortus royalty 3
Slide 7: Strategic portfolio set to be the main contributor to our revenue
Strategic portfolio set to be the main contributor to our revenue Portfolio segments and Revenue, MSEK • In Q1 revenue from strategic % change CER contribution to growth portfolio more than doubled in 6,256 the quarter to SEK 2,193 M Strategic portfolio: Aspaveli/Empaveli, • Royalties of Beyfortus a
Slide 8: Growth continues through pipeline and geographical expansion
Growth continues through pipeline and geographical expansion FDA fast track designation received SEL-212 Pipeline (CRG) Aspaveli (C3G/IC-MPGN) Gamifant Doptelet Strategic (sHLH) Efanesoctocog alfa portfolio Hemophilia A Vonjo Beyfortus Aspaveli (MF & tbd) (RSV royalties) (PNH) Zynlonta Doptelet (2L
Slide 9: Haematology: Doptelet continues to show strong momentum
Haematology: Doptelet continues to show strong momentum (growth of 59% at CER in Q1) Doptelet +59% in Q1 • 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 59% at CER fo
Slide 10: Haematology: Aspaveli/Empaveli launch progressing
Haematology: Aspaveli/Empaveli launch progressing Phase 3 data (VALIANT study) in Nephrology expected in 2H 2024 Solid Aspaveli/Empaveli launch trajectory PNH • Launched in more than 27 countries across EU, International and Canada • Q1 sales SEK 240 M Nephrology • Phase 2 NOBLE study in patients wi
Slide 11: Haematology: Vonjo launch elements in place for growth in 2024
Haematology: Vonjo launch elements in place for growth in 2024 Vonjo SEK 320 M • Sales flat quarter on quarter: insufficient amount of new patient starts in 2023 continue to negatively affect sales in Q1 2024 • Strong indicators of growth inflection point • Additional commercial and medical teams in
Slide 12: Haematology: Strong demand in the haemophilia franchise
Haematology: Strong demand in the haemophilia franchise with double digit growth in Q1 Elocta Alprolix +14% Q1 +17% Q1 • Growth from International expansion • Favourable phasing • Party offset by continued price pressure in many regions Sales in SEK million at actual exchange rates; change at consta
Slide 13: Immunology: RSV season declining with Beyfortus demand partially compensating for Synagis decline
Immunology: RSV season declining with Beyfortus demand partially compensating for Synagis decline RSV season Revenue, SEK M Synagis • Sales impacted by early RSV season peak, in December, and competition from 4,000 Beyfortus. 3,500 • Revenue Q1 SEK 520 M 3,000 Beyfortus royalties 2,500 • Strong laun
Slide 14: Immunology: Gamifant and Kineret
Immunology: Gamifant strategy increasing market share Kineret: increased demand in Europe and US Gamifant Kineret SEK 438 M Gamifant SEK 633 M +100% Q1 +19% Q1 • Growth driven by: • Increase in number of treating centers • Increased patients from new and established centers • Better balanced patient
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 CMO Summary and Q&A 15
Slide 16: Q1 2024 Revenue and profit & loss
Q1 2024 Revenue and profit & loss Q1 Q1 Full-year Total revenue (SEK M) Amounts in SEK M 2024 2023 Change 2023 Total revenue 6,256 5,239 19% 22,123 Haematology Immunology Specialty Care Adjusted Gross profit 1,2 4,735 4,172 13% 17,162 6 844 Adjusted Gross margin 1,2 76% 80% 78% 298 6256 272 EBITA1,2
Slide 17: Outlook 2024
Outlook 2024 Revenue Anticipated to grow by a high single-digit 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 CMO Summary and Q&A 18
Slide 19: Steady pipeline progress
Steady pipeline progress Doptelet SEL-212 ITP Chronic Refractory Gout Positive phase 3 paediatric data FDA fast-track designation Aspaveli/Empaveli Kineret PNH Still’s disease 1-Line positive CHMP1 Approval in China CAD Program terminated1 19 1.Reported as subsequent event in January 2024 ITP: Immun
Slide 20: Doptelet: Positive results from phase 3 study in children and adolescents with ITP
Doptelet: Positive results from phase 3 study for treatment of children and adolescents with ITP AVA-Ped-301 Primary endpoint Secondary endpoint Secondary endpoint Secondary endpoint Avatrombopag for the Durable platelet Two consecutive Platelet response Use of rescue Treatment of response platelet
Slide 21: Vonjo: Strong medical community interest and support
Vonjo: Strong medical community interest and support Clear rationale and Robust support for Accelerating the medical need pacritinib’s potential momentum Progression to cytopenias NCCN Guidelines Engage • Cytopenias are a common feature of • First line, high-risk patients, with strong insights myelo
Slide 22: Vonjo: Convincing evidence base for pacritinib in cytopenic patients
Vonjo: Convincing evidence base for clinical value of pacritinib in cytopenic patients Engage with strong insights Efficacy and Safety1,2 Anaemia3 Pacritinib 200mg BID was more effective than BAT in reducing splenomegaly and symptoms Generally well tolerated, even in patients with severe cytopenias.
Slide 23: Vonjo: Differentiating pacritinib in myelofibrosis
Vonjo: Differentiating pacritinib and strengthening therapeutic rationale for use in myelofibrosis Strengthen Ongoing studies and in myelofibrosis recent publications • Explore unique MOA as dual JAK2/IRAK1 inhibitor Studies Abstracts Myelofibrosis – Improvement in platelet • Improvement in cytopeni
Slide 24: Vonjo: New studies exploring pacritinib's use beyond myelofibrosis
Vonjo: New studies exploring pacritinib’s use beyond myelofibrosis Expand Ongoing studies and knowledge outside MF recent publications Studies Publication Haematologic • Myelodysplastic Syndrome Myelodysplastic Castleman’s: Recent pre- malignancies (MDS) Syndromes and clinical data published – Myelo
Slide 25: Significant events ahead in 2024
Significant events ahead in 2024 Anticipated major pipeline news flow Doptelet Efanesoctocog alfa SEL-212 & Gamifant US & EU (paediatric) EU decision US submissions CN, JP (ITP) 2024 H1 2024 H2 Efanesoctocog alfa – Haemophilia A: Gamifant – sHLH / MAS in • Regulatory decision in EU rheumatological d
Slide 26: 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 26
Slide 27: Summary: Growth and pipeline progress
Summary: Growth and pipeline progress Second consecutive year as Significant growth Revenue Q1 - SEK 6,256 M, +19% (+20% at CER) member of DJSI Europe Doptelet (SEK 756 M, +59% at CER) Strategic portfolio Gamifant (SEK 438 M, +100% at CER) contributing Aspaveli/Empaveli (SEK 240 M, +155% at CER) Se
Slide 28: Q&A
Q&A 28
Slide 29: Appendix: Q1 2024 sustainability performance
Appendix: Q1 2024 sustainability performance Sobi sustainability priorities Highlights in Q1 2024 Highlights in Q1 2024 • Milestones toward increased access • Caring for employees - Positive phase 3 study results of Doptelet - Three employees were recognized in (avatrombopag) in paediatric treatment
Slide 30: Current development pipeline
Current development pipeline Major ongoing clinical studies and medicines in registration in a major region or country Upcoming milestones 2024 H1 Doptelet – ITP: • Regulatory decision in China Efanesoctocog alfa – Haemophilia A: • Regulatory decision in EU SEL-212 – Chronic Refractory Gout: • Regul
Slide 31: 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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