Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (October 2022)
18 slides from Sequana Medical's corporate update, Oct 25, 2022
Slide 1: POSEIDON Primary endpoint results
POSEIDON Primary endpoint results Webcast presentation – 25 October 2022
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Gijs Klarenbeek Chief Executive Officer Sr Medical Advisor 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: Positive top-line results from POSEIDON
Positive top-line results from POSEIDON North American pivotal study of the alfapump® • alfapump achieves pre-specified primary effectiveness endpoints with statistical significance at six months post-implantation: • 100% median per-patient reduction in therapeutic paracentesis (TP) post- vs pre-imp
Slide 5: 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 infections “Normal Life” (Hepatitis B & C) ~5 days Alcoholic Liver Disease Decreased Drainage or mobility &
Slide 6: alfapump – strong clinical and economic rationale
alfapump® – strong clinical and economic rationale Strong IP, over 950 implants and hundreds of years of patient experience Fully-implanted system for automatic and continuous removal of ascites Wireless battery charging and remote data monitoring Reducing the need for paracentesis Improving patient
Slide 7: POSEIDON – North American pivotal study
POSEIDON – North American pivotal study Pivotal Cohort of 40 implanted patients; Roll-In (“training”) Cohort of 29 implanted patients alfapump® Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant Long-term follo
Slide 8: POSEIDON – Pivotal cohort
POSEIDON – Pivotal cohort More than 1/3 of patients implanted with the alfapump® had NASH or combined NASH etiology alfapump therapy still ongoing at day 180 post-implant Actual data used Implanted with Evaluable for primary N = 26 Enrolled in alfapump effectiveness endpoint Pivotal Cohort at 6 mont
Slide 9: Primary effectiveness endpoints met
Primary effectiveness endpoints met Data from the Pivotal Cohort patients substantially exceeded the predefined thresholds for study success Pivotal Cohort N = 40 %* p-value** 1. Frequency of Therapeutic Paracentesis (TP) a. median per-patient ratio 100% reduction P<0.001 b. mean per-patient ratio 8
Slide 10: Observed data from patients completing alfapump therapy through day 180 (1/2)
Observed data from patients completing alfapump® therapy through day 180 post-implant* (1/2) N = 26 % 1. Frequency of TP a. median per-patient ratio 100% reduction b. mean per-patient ratio 93% reduction 2. Proportion of patients with a 50% reduction in number of TP post- vs pre- 92% of patients imp
Slide 11: Observed data from patients completing alfapump therapy through day 180 (2/2)
Observed data from patients completing alfapump® therapy through day 180 post-implant* (2/2) Distribution of reduction in Therapeutic Paracentesis post-implant vs pre-implant (N = 26) * These observed patient data are not part of the main primary effectiveness endpoint analysis. 11 11
Slide 12: Primary safety endpoint in line with expectations
Primary safety endpoint in line with expectations Primary safety endpoint: • Combined rate of i) open surgical re-intervention due to pump system related AE or to restore pump functionality, ii) pump explant (without replacement) due to pump system related AE, or iii) pump system related death from
Slide 13: Next steps
Next steps • Poster presentation of data from the Roll-In Cohort* at AASLD The Liver Meeting® by Dr. Wong, on November 6th between 1:00-2:00 pm EST • Complete secondary efficacy and safety endpoint analysis (e.g., SAE / AE, quality of life) • Present data at upcoming medical liver meeting in 2023 an
Slide 14: North American alfapump approval expected for 2024
North American alfapump approval expected for 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 re
Slide 15: Large and growing North American patient population
Large and growing North American patient population NASH is forecast to drive significant growth in patient numbers for many years to come Over Over 60,000 140,000 6 – 7% annually patients patients 2022 2032 • Patients in North America with recurrent or refractory ascites due to liver cirrhosis • NA
Slide 16: US – Go direct to liver transplant centres
US – Go direct to 140 liver transplant centres Highly efficient approach to target doctors and patients – driven by treatment guidelines 140 ~50 initially - 35 sales reps - 10 clinical specialists - 5 corporate 16 16
Slide 17: Strong Outlook for Value Drivers
Strong Outlook for Value Drivers North American Study – POSEIDON Liver disease / Q1 22: Q4 22: H2 23: NASH completion primary endpoint FDA submission alfapump® implants readout for US approval H1 H2 H1 H2 2022 2022 2023 2023 Q2 22: Heart failure Q4 22: H1 23: H2 23: all patients recruited top-lin
Slide 18: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com