Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q3 2020 Earnings Presentation
27 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Oct 22, 2020
Slide 1: Q3 2020 results
Q3 2020 results October 22, 2020 1
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 Henrik Stenqvist | CFO Presenters Ravi Rao | Head of R&D and CMO 3
Slide 4: Ongoing transformation towards innovative leadership
Ongoing transformation towards innovative leadership From… To… Becoming a Thoughtful M&A and outright In-licensing/distributor agreements 1 ownership global leader in rare diseases Dependence of haemophilia 2 Diversified our portfolio into Haematology and Immunology Few big bets in early R&D 3 5 lat
Slide 5: Operational highlights – Solid quarter in challenging times
Operational highlights – Solid quarter in challenging times Q3 2020 Jan-Sep 2020 Strong financial performance Total sales growth (CER) 6% 14% Total adjusted EBITA growth -15% 10% Adjusted EBITA % of sales (31%) (39%) Haematology sales (CER) 16% 17% Immunology sales (CER) 11% 25% Launch products deli
Slide 6: Pipeline - key assets in solid conditions
Pipeline - key assets in solid conditions BIVV001 – in phase 3 “…may become the Phase 1/2a results - published in NEJM - Potential to first choice among Haematology become first choice among factor VIII replacement products factor VIII replacement products…” Doptelet – launched in CLD and ITP NEJM E
Slide 7: Continued solid top line growth
Continued solid top line growth Q3 sales development Jan-Sep sales development SEK M 10,680 Specialty Care 968 9,358 Immunology (core) Haematology (core) 1,271 3,133 6,568 2,473 1,323 985 2,930 2,970 6,578 2,315 398 204 5,613 600 619 422 4,260 347 1,932 2,147 1,545 Q3 2018 Q3 2019 Q3 2020 Jan-Sep 20
Slide 8: Business Review
@sobl Business Review
Slide 9: Continued double-digit growth for product sales in Haematology
Continued double-digit growth for product sales in Haematology Q3 product sales development Jan-Sep product sales development Highlights SEK M 5,109 • Strong top-line growth in Q3 Growth at CER particularly driven by a +33% 18% increase in Alprolix 4,332 • Despite challenging 40% environment strong
Slide 10: Elocta continued share gain offset by reduction in consumption per patient
Elocta continued share gain offset by reduction in consumption per patient Elocta sales – EU5 countries – Q3 2019 to Q3 2020 Highlights SEK M growth at CER • Continued patient gain • Reduction in consumption per +19.1% -3.1% -12.0% patient impacted by COVID-19 +0.9% -4.9% 848 847 +0% Q3 2019 Patient
Slide 11: Strong top line revenue growth Immunology
Strong top line revenue growth Immunology Q3 product sales development Jan-Sep product sales development SEK M Highlights Growth at CER 3,133 Sales growth in Q3 driven by 25% • Strong double digit top-line 2,473 growth for Kineret 1,493 • Gamifant sales grew by 1,175 83% at CER in Q3 with a 133% pos
Slide 12: Pipeline
@sobl Pipeline
Slide 13: A brief introduction … Ravi Rao
A brief introduction … Ravi Rao Head of R&D and CMO “ Academic career Imperial College London Consultant Rheumatologist Industry experience Chief Medical Officer, Aeglea BioTherapeutics and Senior Lecturer Vice President, Global Medical Head, Imperial College London Immunology-inflammation and Futur
Slide 14: Q3 has been a mixed quarter but strong pipeline with five key assets in phase 2 and 3
Q3 has been a mixed quarter but strong pipeline with five key assets in phase 2 and 3 Product pipeline Phase 1 Phase 2 Phase 3 Registration NI-1701 / Anti-CD47/CD19 Gamifant / emapalumab Gamifant / emapalumab Secondary HLH adults R/R B cell lymphoma Primary HLH (EU) Anakinra/emapalumab Hyperinflamma
Slide 15: Phase 3 read-out for avatrombopag in CIT did not turn out as expected
The read-out of the phase 3 study for avatrombopag in CIT did not turn out as expected and we are analysing the data in order to evaluate options Avatrombopag CIT – Phase 3 study result Ongoing work • No difference in response rate between placebo and avatrombopag groups • We believe an unmet medica
Slide 16: SEL-212 Phase 2 results show potential for greater reductions in Serum Uric Acid
SEL-212 Phase 2 results show the potential for greater reductions in Serum Uric Acid compared to pegloticase Study setup Study results Patients with <6 mg/dl SUA (Serum Uric Acid) for at least Reduction in mean Serum Uric Acid (mg/dL) 129 80% of the evaluation time all patients patients with chronic
Slide 17: SEL-212 phase 3 study has commenced
SEL-212 phase 3 study has commenced SEL-212 is being evaluated in a pivotal phase 3 programme, first patient randomised in September 2020 with topline data expected in 2H 2022 SEL-212 - 0.1/0.2 mg/kg Study 1 N= 35 SEL-212 - 0.15/0.2 mg/kg subjects/arm Placebo SEL-212 - 0.1/0.2 mg/kg Study 2 N= 35 su
Slide 18: BIVV001 phase 1/2 results show high sustained factor activity levels
BIVV001 phase 1/2 results show high sustained factor activity levels Structure of the BIVV001 Fusion Protein “…it may become the first choice among factor VIII replacement products…” 2 XTEND-1: ongoing phase 3 study in severe hemophilia A “…an authentic factor VIII is more attractive than a • 150 pr
Slide 19: Clinical development of Gamifant for graft failure (start Q1 2021)
Clinical development of Gamifant for graft failure (start Q1 2021) Large potential patient pool Total of ~24,000 patients (children and adults) undergoing hematopoietic stem cell transplantation (HSCT) every year with ~10% experiencing acute graft failure (aGF) Two studies planned for Q1 2021 CXCL9
Slide 20: Research collaboration with bioMerieux to develop a CoDx for Gamifant
Research collaboration with bioMerieux to develop a CoDx for Gamifant in Graft Failure post HSCT Research collaboration for a CXCL9 companion diagnostic assay VIDAS™ CXCL9 for the prevention of graft failure post HSCT received breakthrough device designation by FDA in May 2020 • Fast turnaround (~1h
Slide 21: Q3 2020 financial results
@sobl Q3 2020 financial results
Slide 22: Q3 2020: Financial results
Q3 2020: Financial results Total revenue (SEK M) Q3 Q3 Jan – Sept Jan – Sept Full-year Specialty Care Amounts in SEK M 2020 2019 Change 2020 2020 Change 2019 Immunology Haematology Total revenue 2,970 2,930 1% 10,680 9,358 14% 14,248 4,890 4,639 Gross profit 2,339 2,173 8% 8,318 7,080 17% 10,913 516
Slide 23: Seasonal impact on cash flow in Q3, leverage < 2.0x
Seasonal impact on cash flow in Q3, leverage < 2.0x Net Debt (SEK M) Q3 2020 update 16 000 -2.7B • Operating cash flows of SEK 0.4B 12 000 • Net debt increased by SEK 0.9B due to SEL-212 acquisition and settlement of Alprolix debt, offset by operating cash 8 000 flow • Leverage remains below 2.0x 4
Slide 24: Q3 2020 Summary
@sobl Q3 2020 Summary
Slide 25: We have forcefully responded to the COVID-19 pandemic
We have forcefully responded to the COVID-19 pandemic Secure health and safety of all employees 1 We encourage work from home We cancelled all business travel Safeguard supply of medication 2 We assess whether COVID impacts the supply of our medicines We introduce mitigation measures where needed En
Slide 26: Financial outlook 2020 – updated
Financial outlook 20201 – updated Revenue for the full-year 2020 is expected to be in the range of SEK 15,000—15,500 M. EBITA is expected to be in the range of SEK 5,700—6,200 M. . 1.Assuming exchange rates as of September 30 remain stable during the fourth quarter of 2020 26
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