Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Jefferies London Healthcare Conference 2022
21 slides from Sequana Medical's conference presentation, Nov 17, 2022
Slide 1: Pioneers in the treatment of drug-resistant fluid overload
Pioneers in the treatment of drug-resistant fluid overload liver disease, heart failure & cancer Jefferies London Healthcare Conference Ian Crosbie, CEO – 17 November 2022 Euronext: SEQUA.BR
Slide 2: 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 3: Strongly positioned in two large markets
Strongly positioned in two large markets • Proprietary technologies treating diuretic-resistant fluid overload • Key clinical problem in liver disease, heart failure, renal failure and cancer • Diuretic-resistance is common – alternatives have significant disadvantages • Strong granted IP portfolio
Slide 4: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump® study – POSEIDON Liver disease / H2 23: NASH Q4 22: primary endpoint FDA submission readout for US approval H2 H1 H2 H1 2022 2023 2023 2024 Q4 22: Heart failure Q1 23: H1 23: H2 23: mid 24: top-line results IND filing Start study Interim
Slide 5: alfapump®
alfapump® Proven step change in the treatment of liver refractory ascites
Slide 6: alfapump
alfapump Eliminating fluid from the peritoneal cavity – working in partnership with the bladder Fully implanted Easy implantation Long-term implantation & catheter Automatic operation patency Wireless battery charging Moves up to 4 litres / day Settings wirelessly adjusted Virtually non-clogging Rem
Slide 7: Refractory ascites – key complication of liver cirrhosis
Refractory ascites – key complication of liver cirrhosis Fatty liver disease / NASH is driving dramatic growth and change in attitudes to liver cirrhosis patients Typical patient life(1) Viral Alcoholic Liver infections “Normal Life” Disease (Hepatitis B & C) ~5 days Non-Alcoholic Steatohepatitis De
Slide 8: 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- v
Slide 9: North American alfapump approval expected in 2024
North American alfapump approval expected in 2024 2022 2023 2024 POSEIDON Completion Primary Secondary alfapump endpoint endpoint implants readout readout PMA submission US Launch US Commercial Scale-Up Head of Clinical Sales N. America specialists Reps NTAP for breakthrough devices de-risks rei
Slide 10: 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 60,000 140,000 refractory ascites due to liver cirrhosis 2022 2032 • NASH is a key
Slide 11: US – Go direct to liver transplant centers
US – Go direct to 140 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines 140 ~50 initially - 35 sales reps - 10 clinical specialists - 5 corporate 11 11
Slide 12: DSR®
DSR® Disease-modifying heart failure drug therapy
Slide 13: Congestion is driver of morbidity and hospitalization
Congestion is driver of morbidity and hospitalization Diuretic-resistance is common and there are few effective clinical alternatives US hospitalizations HF – annually due to ~1m 90% hospitalizations HF(3) due to fluid overload (AKA congestion)(3) c.5d Typical Annual costs of US hospital stay(4) HF-
Slide 14: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Eliminating fluid spread across the body – working in partnership with the kidneys 1 Sodium-free DSR product 2 Sodium diffuses from 3 DSR product + extracted 4 Body eliminates free water administered to peritoneal body into DSR product sodium removed from body to restore
Slide 15: RED DESERT & SAHARA: Clinical Proof-of-Concept
RED DESERT & SAHARA: Clinical Proof-of-Concept 8 euvolemic and 10 decompensated heart failure patients on high-dose loop diuretics treated with DSR Clinically meaningful decongestion and durable improvements in cardio-renal health Safe, effective and rapid elimination of fluid overload / restoring
Slide 16: Moving to proprietary DSR 2.0
Moving to proprietary DSR 2.0 Improved clinical and safety profile driving 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 Favorabl
Slide 17: 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 2021 2022 2023 2024 DSR 1.0 - Phase 2a study SAHARA - Proprietary DSR 2.0 product development CMC - GLP animal studies (safety) DSR 2.0 - YUKON & CHIHUAHUA first-in-human stu
Slide 18: 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 19: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 20: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump® study – POSEIDON Liver disease / H2 23: NASH Q4 22: primary endpoint FDA submission readout for US approval H2 H1 H2 H1 2022 2023 2023 2024 Q4 22: Heart failure Q1 23: H1 23: H2 23: mid 24: top-line results IND filing Start study Interim
Slide 21: Thank You
Thank You sequanamedical
Sequana Medical — Jefferies London Healthcare Conference 2022 on 6ix