Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q4 2020 Earnings Presentation
30 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Feb 18, 2021
Slide 1: Q4 and FY 2020 results
Q4 and FY 2020 results 18 February, 2021
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) is providing the following cautionary statement. This presentation contains forward-looking statements with respect to
Slide 3: Presenters
Guido Oelkers | CEO Presenters Henrik Stenqvist | CFO Ravi Rao | Head of R&D and CMO 3
Slide 4: Expanding opportunities – strong growth and profitability
Expanding opportunities – strong growth and profitability • Solid revenue and profitability growth - FY 2020 revenue of SEK 15,261 M and an adjusted EBITA margin of 41% - Q4 revenue of SEK 4,581 M and an adjusted EBITA margin of 48% • Double-digit growth in Core business FY 2020 - Haematology 13 per
Slide 5: Two vectors of growth propel our business
Two vectors of growth propel our business Pipeline/launch of products and internationalisation fuel mid-term growth Portfolio 2. Deliver on our late-stage pipeline and launch (60-70% of growth) 2. Deliver on our late-stage • 12 late-stage programs New pipeline and launch • Develop Gamifant beyond pH
Slide 6: Key pipeline catalysts
Key pipeline catalysts 32 launches in key geographies by 2025 – 4 in 2021 Approval of Elocta in Russia Approval Kineret in Russia Approval of Doptelet ITP/CLD in EU Submitted Doptelet in Russia; potential approval in Q4 Submitted Pegcetacoplan (PNH) in EU; potential approval in Q4 SEL-212 progressin
Slide 7: Ramping up our international expansion
Ramping up our international expansion • Created a presence in China, Japan and Australia and build out our representation in Russia • Russia: Elocta approved, Kineret approved in CAPS, Doptelet submitted in Russia for ITP and CLD in Q4 2020 • China: Emapalumab and nitisinone submitted in 2020 • Jap
Slide 8: Haematology
Haematology 8
Slide 9: Haematology – continued market share gain
Haematology – continued market share gain Revenue (SEK M) • FY revenue of SEK 8,660 M (7,755) - Revenue growth of 12 per cent (13 per cent at CER) • Elocta strengthened positions in key markets with continued patient gain - Patient increase by > 10% in 2020 - COVID-19 impacted consumption per patien
Slide 10: Elocta and Alprolix
Elocta and Alprolix Competitive franchise – expansion of patient share in 2020 Elocta sales (SEK M) Alprolix sales (SEK M) Continued strong growth of patients offset to a large extent Patients on Alprolix grew by 25 per cent FY 2020 and 4 per by reduced consumption/patient; sales growth 3 per cent a
Slide 11: Doptelet – having an impact on the TPO RA market in US
Doptelet – having an impact on the TPO RA market in US Sales (SEK M) • FY sales of SEK 587 M (341) • Q4 sales of SEK 191 M (341) • US: strengthened market share in Q4 (7% in ITP) • International: - Product makes good progress in China by Fosun - EMA approval of ITP indication in January 2021 1) 12 N
Slide 12: Immunology
Immunology 12
Slide 13: Immunology – solid growth
Immunology – solid growth Revenue (SEK M) • Q4 revenue of SEK 2,281 M (2,233) - Revenue growth of 2 per cent (6 per cent at CER) • FY revenue of SEK 5,415 M (4,706) - Revenue growth of 15 per cent (16 per cent at CER) • Synagis has performed well, even though the incidence of RSV was heavily impacte
Slide 14: Kineret – accelerated sales growth
Kineret – accelerated sales growth Sales (SEK M) • Q4 sales of SEK 586 M (396) - Sales growth of 48 per cent (59 per cent at CER) • FY sales of SEK 2,079 M (1,571) - Sales growth of 32 per cent (35 per cent at CER) • New indication for DIRA (deficiency of the interleukin- 1 receptor antagonist) gran
Slide 15: Gamifant – strong patient growth
Gamifant – strong patient growth Sales (SEK M) • Q4 sales of SEK 263 M (180) - Sales growth of 46 per cent (56 per cent at CER) • FY sales of SEK 609 M (542) - Sales growth of 12 per cent (16 per cent at CER) • Number of patients grew by 67 per cent FY 2020, driven by education and awareness • Emapa
Slide 16: R&D
R&D 16
Slide 17: Substantial value in our late-stage pipeline
Substantial value in our late-stage pipeline1 Phase 2 Phase 3 In registration Gamifant / emapalumab Gamifant / emapalumab Gamifant / emapalumab Secondary HLH malignancy Secondary HLH rheumatology Primary HLH (RoW) Gamifant / emapalumab SEL-212 / pegadricase3 pegcetacoplan 2nd line2 GvHD Chronic refr
Slide 18: Pegcetacoplan: potential to elevate the standard of care in PNH
Pegcetacoplan: potential to elevate the standard of care in PNH PEGASUS: Phase 3 head -to-head study of pegcetacoplan vs eculizumab Primary endpoint Baseline Day 1 read out 4 weeks 16 weeks 32 weeks open-label run-in randomised period 4 weeks 28 weeks GROUP 1, N=41 GROUP 1, N=38 GROUP 1+2, N=77 pegc
Slide 19: Pegcetacoplan: potential to elevate the standard of care in PNH
Pegcetacoplan: potential to elevate the standard of care in PNH Met primary endpoint in phase 3 PEGASUS study vs eculizumab at week 16 superior 3.8 g/dL improvement in adjusted means pegcetacoplan vs to eculizumab on improving eculizumab p<0.0001 hemoglobin levels Meaningful improvements across key
Slide 20: Pegcetacoplan demonstrated sustained improvements in hemoglobin at week 48
Pegcetacoplan demonstrated sustained improvements in hemoglobin and clinical measures at week 48 Hemoglobin increase from baseline at week 48 equal to increase at week 16 13 Hemoglobin 12 LLN Female 11 Hemoglobin (g/dL) Mean(±SE) 10 Pegcetacoplan (RCP) to pegcetacoplan (OLP) 9 Eculizumab (RCP) to pe
Slide 21: Efanesoctocog alfa (BIVV001) expected to be submitted in US in 2022
Efanesoctocog alfa (BIVV001) expected to be submitted in US in 2022 Study timeline Key design aspects Phase 3 in 2019 2020 2021 2022 2023 Arms: Multi-centre, open-label, • Phase 3 enrolment adults & non-randomized 2-arm (prophylaxis and on-demand); previously treated completed adolescents N= 150 pat
Slide 22: Q4 and FY 2020 Financial Results
Q4 and FY 2020 Financial Results 22
Slide 23: Q4 2020: Financial results
Q4 2020: Financial results Total revenue (SEK M) Q4 Q4 Full-year Full-year Specialty Care Amounts in SEK M 2020 2019 Change 2020 2019 Change Immunology Total revenue 4,581 4,890 -6% 15,261 14,248 7% Haematology 4,890 Gross profit 3,718 3,833 -3% 12,036 10,913 10% 4,639 4,581 516 218 445 Gross margin
Slide 24: Outlook
Guido Oelkers Outlook CEO 24
Slide 25: Impact of COVID-19 on our business
Impact of COVID-19 on our business 48 per cent of our business impacted directly/indirectly by COVID-19 Elocta • Currently lower consumption per patient compared to pre COVID-19 levels • Due to economic pressure on health systems and increased competition prices for Haemophilia products will be adju
Slide 26: Financial outlook 2021
Financial outlook 2021 Revenue for the full-year 2021 is expected to be in the range of SEK 14–15 bn ✓ Launch progress Doptelet and Gamifant At constant exchange rates this range corresponds to a revenue growth of between -2,5 and 4,5 per cent ✓ Strong underlying growth for Kineret ✓ Elocta impacted
Slide 27: Revenue outlook of 14.0 to 15.0 bn equals -2.5 to 4.5% growth @CER
Revenue outlook of 14.0 to 15.0 bn (@ Jan closing rates) equals -2.5 to 4.5 % growth @CER (average 2020 rates) 2021 Revenues (SEK bn) Guidance At CER1 CER Growth at Jan closing rates Low end 14.0 14.9 -2.5% Mid point 14.5 15.4 1.0% High end 15.0 15.9 4.5% 1 CER is 2020 average rates 27
Slide 28: Conclusions
Conclusions Proven track record; demonstrated strong impact against large competitors Robust and diversified in 2 therapeutic areas Strong cash flows out of the operating business 12 late stage projects; great opportunities for growth requiring funding Various catalysts for sustainable value creatio
Slide 29: Q&A
Q&A 29
Slide 30: Sobi trademark and contact details
Sobi is a trademark of Swedish Orphan Biovitrum AB (publ). © 2020 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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