Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — FY2022 Earnings Presentation
18 slides from Sequana Medical's earnings presentation, Feb 9, 2023
Slide 1: FY 2022 Financial Results & Business Update
FY 2022 Financial Results & Business Update Webcast presentation – 9 February 2023
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Kirsten Van Bockstaele Chief Executive 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: Strong progress in both programs
Strong progress in both programs alfapump on track for PMA filing and DSR on track for start of MOJAVE, a US randomized controlled study alfapump® – US approval in liver disease expected in 2024 Primary effectiveness endpoints of pivotal POSEIDON study substantially exceeding predefined thresholds
Slide 5: FY '22 in Review: alfapump in liver disease / NASH
FY ‘22 in Review: alfapump® in liver disease / NASH North America POSEIDON: POSEIDON: POSEIDON: POSEIDON: US patient alfapump Completion of Interim analysis of Roll-In All primary Roll-In Cohort preference study implantations Cohort* reports 70% survival endpoints met data presented at initiated AAS
Slide 6: POSEIDON – successful North American pivotal study
POSEIDON – successful North American pivotal study 40 patients with recurrent or refractory ascites due to liver cirrhosis implanted with the alfapump Primary effectiveness endpoints exceed predefined thresholds for study success • 100% median per-patient reduction in therapeutic paracentesis post-
Slide 7: North American alfapump approval expected in 2024
North American alfapump approval expected in 2024 2022 2023 2024 POSEIDON & related studies Completion Primary Data patient Secondary alfapump endpoint preference endpoint implants readout study readout US FDA PMA submission US approval NTAP for breakthrough devices de-risks reimbursement in key
Slide 8: Large and growing North American patient population
Large and growing North American patient population NASH is forecast to drive significant growth for many years – and changing attitudes to cirrhosis North American patients with Over Over recurrent or 6 – 7% annually 75,000 170,000 refractory ascites due to liver cirrhosis 2025 2035 Market potentia
Slide 9: US – Go direct to liver transplant centers
US – Go direct to 90 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines 125 adult centres, of which 90 cover 95% of transplants ~50 commercial team initially Source: Organ Procurement & Transplantation Network, US Dept of HHS (optn.tran
Slide 10: FY '22 and YTD '23 in Review: DSR in heart failure
FY ‘22 and YTD ‘23 in Review: DSR® in heart failure SAHARA DESERT: SAHARA DESERT: CHIHUAHUA: Positive Phase 2a Positive Phase 2a First patient dosed interim data top-line data successfully DSR 2022 DSR 2023 YUKON: IP: GLP studies: First patient dosed additional US Safety of DSR successfully DSR pate
Slide 11: DSR – disease-modifying heart failure drug therapy
DSR – disease-modifying heart failure drug therapy RED DESERT and SAHARA deliver clinical proof-of-concept of DSR with long-lasting clinical benefits Clinically meaningful decongestion and durable improvements in cardio-renal health Safe, effective and rapid elimination of fluid overload / restori
Slide 12: DSR 2.0 has improved therapeutic and safety profile
DSR 2.0 has improved therapeutic and safety profile Strong granted IP drives high margin recurring revenue stream DSR 1.0 DSR 2.0 Sodium-free D10% (off-the-shelf) Sodium-free dextrose / icodextrin (proprietary) Clinical proof-of-concept Improved therapeutic profile Rapid clinical path Favora
Slide 13: MOJAVE as package for DSR partnering
MOJAVE as package for DSR partnering Leveraging the strengths of established HF player to realise commercial potential of DSR 2022 2023 2024 - Proprietary DSR 2.0 product development CMC - GLP animal studies (safety) - Phase 1 study (Canada) YUKON up to 10 patients on stable peritoneal dialysis, sin
Slide 14: Multi-billion market opportunity
Multi-billion market opportunity Delivering value through reduced hospitalization and improved survival • ~400K chronically congested HF patients hospitalized per year in the US and EU (“frequent flyers”) • High cost patients with major burden on healthcare systems, payors and patients • Value based
Slide 15: Key financial results FY 2022
Key financial results FY 2022 Cash runway into mid-2023 Revenue: €923K • Resumed commercial activity in Europe as the impact of COVID declines Operating expenses: - €29.3M • Preparation of submissions for marketing approval in US and Canada • Pre-clinical and clinical development of proprietary DSR
Slide 16: Shareholder base
Shareholder base Share transfer from Neomed V to Rosetta Capital, a long-term life sciences shareholder • Outstanding shares: 23.7M • Outstanding shares corresponding to outstanding share options: 2.7M 16 16
Slide 17: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump study – POSEIDON Liver disease / Q4 ‘22: H2 ‘23: H2 ‘23: NASH Primary endpoint Data patient FDA submission readout preference study for US approval H2 H1 H2 2022 2023 2023 Q4 ‘22: Heart failure Q1 ‘23: Q2 ‘23: H2 ‘23: Top-line results IND fi
Slide 18: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com