Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — FY2020 Earnings Presentation
17 slides from Sequana Medical's earnings presentation, Mar 17, 2021
Slide 1: FY2020 Financial Results & Business Update
FY2020 Financial Results & Business Update 17 March 2021
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Oliver Gödje Kirsten Van Bockstaele Chief Executive Officer Chief Medical Officer Chief Financial Officer 2 2
Slide 3: Disclaimers
Disclaimers Important Notice IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by Sequana Medical NV (the "Company") or any person on behalf of the Company, and any question-and-answer session t
Slide 4: Disclaimers
Disclaimers Regulatory disclaimer: • The alfapump® system has not yet received regulatory approval in the United States and Canada. Any statement in this presentation about safety and efficacy of the alfapump® system does not apply to the United States and Canada. In the United States and Canada, th
Slide 5: 2020 – YTD Highlights
2020 – YTD Highlights POSEIDON – positive interim results reported; additional interim results expected in Q2 2021 RED DESERT – positive interim results reported; top-line results expected in Q2 2021 alfapump DSR® – fundamental patents granted in US and Europe Positive data published in two
Slide 6: One platform – two products – multi-billion euro opportunities
One platform – two products – multi-billion euro opportunities alfapump® alfapump DSR® Liver Disease (NASH) Heart Failure CE mark / FDA Breakthrough Device Clinical proof-of-concept of Over 850 devices implanted Direct Sodium Removal (DSR®) > €3 Bn / year market opportunity(1) > €5 Bn / year market
Slide 7: Year in Review: alfapump 2020 – YTD
Year in Review: alfapump® 2020 – YTD North America Liver Transplantation POSEIDON: positive alfapump published results of North interim results American feasibility study reported in first 13 (MOSAIC) Roll-In patients alfapump alfapump 2020 2021 alfapump Europe Langenbeck’s Archives of Surgery Tempo
Slide 8: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from first 13 Roll-In patients implanted with the alfapump® EFFICACY Over 90% reduction in mean frequency of Therapeutic Paracenthesis (TP) post-implant vs. pre-implant (primary endpoint of >50% reduction) All patients experienced at least a
Slide 9: Pursuing North American approval of alfapump
Pursuing North American approval of alfapump® Targeting primary endpoint read-out in Q2 2022 • POSEIDON – additional upcoming data read-out: • Completion of patient enrolment expected in Q2 2021 (small delay due to COVID-19 impact) • Interim results of larger Roll-In Cohort (up to 30 patients) expec
Slide 10: Temporary interruption of alfapump European commercial supply
Temporary interruption of alfapump® European commercial supply Low manufacturing yield of alfapump systems • Prioritisation of POSEIDON and RED DESERT POSEIDON and RED DESERT remain on track studies • Limited supply of alfapump systems to European commercial markets Addressing manufacturing yiel
Slide 11: Year in Review: alfapump DSR 2020 – YTD
Year in Review: alfapump DSR® 2020 – YTD RED DESERT: first RED DESERT: strong alfapump DSR patient treated with safety & efficacy results patents granted in alfapump DSR reported in first 5 patients US and Europe alfapump alfapump DSR 2020 DSR 2021 Circulation published Appointment of two KOL event
Slide 12: Interim RED DESERT: Strong safety & efficacy results
Interim RED DESERT: Strong safety & efficacy results Results from first five patients after 6-week repeated dose alfapump DSR® therapy SAFE & WELL- HIGHLY RESTORATION OF DIURETIC TOLLERATED EFFECTIVE RESPONSIVENESS No progressive No diuretics required during Sodium excretion more hyponatremia the 6-
Slide 13: alfapump DSR: Upcoming clinical milestones
alfapump DSR®: Upcoming clinical milestones Building the clinical evidence and experience of DSR in treatment of diuretic-resistant fluid overload • RED DESERT: Top-line data in up to 10 patients expected in Q2 2021 • SAHARA DESERT: • Dose-ranging feasibility study of alfapump DSR in decompensated h
Slide 14: SAHARA DESERT: Study design
SAHARA DESERT: Study design Dose-ranging study to investigate improvement in diuretic response and durability of effect • 20 decompensated heart failure patients with residual congestion, implanted with alfapump DSR • Group 1 (N= 10): DSR treatment plus standard dose of SGLT2-inhibitor • Group 2 (N=
Slide 15: Key Financial Results FY 2020
Key Financial Results FY 2020 Revenue: €963K (-1%) • Strong growth in Germany and France in H1 2020 • Delay in supply of alfapump to European commercial markets in Q4 2020 Operating expenses: - €18,532K (+26%) • POSEIDON & RED DESERT studies and operational costs • Preparation of commercial marketin
Slide 16: Expected core value drivers & outlook
Expected core value drivers & outlook NASH in North Liver disease / POSEIDON Q4 20: Q2 21: Q2 21: Q2 22: America POSEIDON POSEIDON POSEIDON 1st interim analysis LPI 2nd interim analysis primary endpoint Q4 2020 2021 H1 2022 Heart failure in North America Q4 20: & Europe Q2 21: Q2 21: Q4 21: H1 22
Slide 17: Q&A
Q&A