Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q1 2021 Earnings Presentation
28 slides from Swedish Orphan Biovitrum Ab's earnings presentation, May 4, 2021
Slide 1: Q1 2021 results
Q1 2021 results 4 May, 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: Investing in growth - highlights in Q1
Investing in growth - highlights in Q1 • Financial outlook unchanged for 2021 • Strong growth for key products - Doptelet growth, 222 per cent at CER - Kineret growth, 20 per cent at CER - Gamifant, 47 per cent at CER • Maintaining competitiveness in Haemophilia - Patient growth: - 6 per cent for El
Slide 5: Perspective on Q1 revenue
Perspective on Q1 revenue Growth at CER Adjusted Growth 4.6 -13% +10% 4.2 -0.4 0.3 3.7 -0.4 3.3 -0.5 Q1 2020 as Currency adj. Q1 2020 at Q1 2021 One Time Transitory Q1 2020 adjusted Q1 2021 growth Q1 2021 as reported reported rates COVID impact reported Figures reported in SEK bn 5
Slide 6: Haematology
Haematology 6
Slide 7: Haematology – continued patient gain for Elocta and Alprolix
Haematology – continued patient gain for Elocta and Alprolix Revenue (SEK M) 2 800 • Q1 revenue of SEK 1,877 M (2,394) 2 400 • Elocta and Alprolix strengthened position with continued patient gain 2 000 - COVID-19 impacted consumption per patient 1 600 - Price pressure in core markets 1 200 - One of
Slide 8: Elocta sales bridge
Elocta sales bridge MSEK at CER +8.4% -12.0% One time items 1 342 112 161 -9.6% 129 -14.3% 193 -7.2% +1.8% Transitory 96 899 24 COVID item Q1 2020 Net patient gains Consumption Price One time stocking One-time Other Q1 2021 per patient effect due to retrospective price COVID-19 effect Germany in Q1
Slide 9: Alprolix sales bridge
Alprolix sales bridge One time item MSEK at CER +20.2% -12.3% 60 -1.2% -15.0% 98 6 484 -14.3% 73 -1.8% 434 9 Transitory 96 COVID item Q1 2020 Net patient gains Consumption Price One-time stocking Other Q1 2021 per patient effect due to COVID-19 in Q1 2020 9
Slide 10: Doptelet – growth driven by new patients and sites
Doptelet – growth driven by new patients and sites Total sales (SEK M) 200 180 • Q1 sales of SEK 180 M (65) 160 • EU: EMA approval of ITP indication 140 120 • US: expanded market share in Q1 100 80 60 40 20 0 Q4 Q1 Q2 Q3 Q4 Q1 2020 2021 10
Slide 11: Immunology
Immunology 11
Slide 12: Immunology – solid growth
Immunology – solid growth Revenue (SEK M) • Q1 revenue of SEK 1,554 M (1,800) 2 500 6000 • Synagis impacted by low virology of RSV; epidemic 2 000 4800 levels have been reached in 3 states in April • Strong underlying demand for Kineret and Gamifant 1 500 3600 1 000 2400 500 1200 0 0 Q1 Q2 Q3 Q4 Q1
Slide 13: Kineret – strong double digit growth in Q1
Kineret – strong double digit growth in Q1 Sales (SEK M) 600 2 400 • Q1 sales of SEK 542 M (501) 500 2 000 • Strong underlying demand 400 1 600 • Approved in Russia for treatment of CAPS 300 1 200 • SAVE MORE: results for Kineret in treatment of COVID- 19 related severe respiratory failure; strong b
Slide 14: Gamifant – strong patient growth
Gamifant – strong patient growth Sales (SEK M) 300 750 • Q1 sales of SEK 133 M (104) - Sales growth of 47 per cent at CER • Growth driven by number of new patients, 200 500 progress in patient identification process • Volatility still subject to weight difference in patient 100 250 population by qua
Slide 15: R&D
R&D 15
Slide 16: R&D progress in Q1
R&D progress in Q1 • Kineret (anakinra)– SAVE MORE demonstrated positive results in management of COVID19 pneumonia • Kineret – approved in Russia for treatment of CAPS • Doptelet – approved for ITP in Europe • Efanesoctocog alfa (BIVV001) paediatric study – first patient dosed in April 2021, on the
Slide 17: Early, targeted anakinra treatment improves COVID-19 outcome
Early, targeted anakinra treatment improves COVID-19 outcome Positive results from the SAVE MORE investigator sponsored study • Anakinra vs placebo on a background of standard of care - Includes remdesevir, dexamethasone, anticoagulants • Hospitalised patients with COVID19 pneumonia • Moderate-sever
Slide 18: SAVE-MORE study: key highlights
SAVE-MORE study: key highlights 606 patients randomised across 40 centres in Greece and Italy • 60% of screened patients were suPAR+ Patient status at D28 SOC + placebo SOC + anakinra Modified WHO CPS Europe (April 2021) Uninfected Ambulatory, ~175,000 patients mild disease hospitalised Hospitalised
Slide 19: 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 Graft failure (GF) Secondary HLH rheumatology Primary HLH (RoW) Gamifant / emapalumab SEL-212 / pegadricase3 pegcetacoplan 2nd line2 GvHD Chronic refractory
Slide 20: Q1 financial results
Q1 financial results 20
Slide 21: Q1 2021: Financial results
Q1 2021: Financial results Total revenue (SEK M) Q1 Q1 Full-year Amounts in SEK M 2021 2020 Change 2020 Specialty Care Total revenue 3,661 4,639 -21% 15,261 Immunology Haematology Gross profit 2,935 3,598 -18% 12,036 4,639 4,581 Gross margin1 80% 78% 79% 445 218 EBITA adjusted1,2 1,484 2,173 -32% 6,
Slide 22: SG&A – opex evolution
SG&A – opex evolution 1,061 1,092 1,000 981 • SG&A expected to gradually increase in the 947 remainder of 2021 due to: - Doptelet CLD & ITP launch in Europe - Increased investments in launch activities for pegcetacoplan - Increased investments in geographic expansion (Russia, China & Japan) - “Retur
Slide 23: R&D – opex evolution
R&D – opex evolution 486 471 405 • Q1 R&D in line with guidance at 13-15% of 359 345 revenue • FY guidance remains at 13-15% of revenue, incremental spend is expected from: - Pegcetacoplan, various indications - SEL-212 to increase in future quarters as Phase 3 trials progress Q1 20 Q2 20 Q3 20 Q4 2
Slide 24: Conclusion
Conclusion 24
Slide 25: Financial outlook unchanged for 2021
Financial outlook unchanged for 2021 Revenue for the full-year 2021 is expected to be in the range of SEK 14–15 bn EBITA margin is expected to be in the range of 30–35 per cent of revenue 25
Slide 26: Increasing confidence to grow the company at CER
Increasing confidence to grow the company at CER based on… 1. Traction with launch and growth products 2. Positive signals to overcome transitory COVID related effects 3. Delivery in R&D 4. Material opportunity related to Kineret
Slide 27: Q&A
Q&A 27
Slide 28: Sobi is a trademark of Swedish Orphan Biovitrum AB (publ)
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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