Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Needham Healthcare Conference, April 2022
27 slides from Sequana Medical's conference presentation, Apr 13, 2022
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Needham Healthcare Conference, April 2022 Ian Crosbie, CEO Euronext: SEQUA.BR Innovators in the treatment of diuretic-resistant fluid overload
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: Uniquely positioned in two large markets
Uniquely positioned in two large markets • alfapump® in liver disease – over €3 Bn / year (1) • NASH is changing liver cirrhosis market and driving growth • Approved in EU / FDA breakthrough designation in US • North American pivotal study de-risked / primary endpoint Q4 ‘22 • Direct commercialisati
Slide 4: Strong outlook for value drivers
Strong outlook for value drivers North American Pivotal Study Liver disease / Q4 21: Q1 22: Q4 22: Mid 23: NASH POSEIDON POSEIDON POSEIDON FDA submission all patients recruited completion alfapump® implants primary endpoint readout for US approval 2021 2022 2023 Heart failure Q4 21: SAHARA H1 22
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 Re
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 ~3-4M (1) Viral “Normal Life” Liver infections (Hepatitis B & C) ~5 days cirrhosis Decreased ~1.5M (2) mobility & Drainage appetite, Alco
Slide 8: NASH transforming the face of liver cirrhosis
NASH transforming the face of liver cirrhosis In US, liver cirrhosis is transitioning to a mainstream disease requiring modern treatment options alfapump® market potential > €3 Bn / year Underlying disease NASH Patient characteristic “Mainstream” 8 8 Notes: forecast US Liver market: Management estim
Slide 9: Limitations of existing therapies
Limitations of existing therapies Drainage (“Large Volume Transjugular Intrahepatic Paracentesis / LVP”) Portosystemic Shunt (TIPS) Painful, Poor Quality of alfapump® Complications, Life, Short Term Benefit Contraindications Permanent Catheter System Liver transplantation External Catheter, High Cos
Slide 10: alfapump strong clinical and economic rationale
alfapump® strong clinical and economic rationale Over 900 implants and hundreds of years of patient experience • Reduced burden of disease • Improved patient QoL • Cost savings for hospitals and payers Estimated treatment cost / patient*: LVP: ~$54K alfapump®: ~$35K ~$1.8K / LVP(1) ~$25K / alfapump
Slide 11: North American Pivotal Study (POSEIDON) underway
North American Pivotal Study (POSEIDON) underway 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 Post-implant
Slide 12: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from first 26 Roll-In patients EFFICACY Over 90% reduction in mean Therapeutic Paracentesis (TP) frequency (primary endpoint >50% reduction) 100% patients with > 50% reduction in mean TP frequency per month (primary endpoint >50% of patients)
Slide 13: Interim POSEIDON: 70% survival at 12 months
Interim POSEIDON: 70% survival at 12 months Preliminary survival rate analysis of Roll-In Cohort (25 March 2022) Mean survival probability of 70% at 12 months compares favourably to published literature reporting a survival rate for refractory ascites patients of only 50% at 12 months1 13 13 Source
Slide 14: North American alfapump approval on track for 2024
North American alfapump® approval on track for 2024 2021 2022 2023 POSEIDON Interim Completion Completion Primary analysis 2 patient alfapump endpoint enrolment implants readout Start building US PMA infrastructure submission NTAP for breakthrough devices de-risks reimbursement in key Medicare
Slide 15: US – Go direct to 140 liver transplant centres
US – Go direct to 140 liver transplant centres Highly efficient approach to target doctors and patients – driven by treatment guidelines 140 liver transplant centres ~50 person team initially - 35 sales reps - 10 clinical specialists - 5 corporate 15 15
Slide 16: DSR
DSR ® Breakthrough approach to persistent congestion in heart failure
Slide 17: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Removal of congestion is a key therapeutic target and maintaining renal function is a clinical challenge US hospitalisations HF – annually due to ~1m 90% hospitalisations HF(3) due to fluid overload(3) c.5d Typical Annual costs of US hospital stay(4) HF
Slide 18: Direct Sodium Removal (DSR) platform
Direct Sodium Removal (DSR®) platform Eliminating fluid spread across the body – working in partnership with the kidneys 1 Sodium-free DSR infusate 2 Sodium diffuses from 3 DSR infusate + extracted 4 Body eliminates free water administered to peritoneal body into DSR sodium removed from the to resto
Slide 19: alfapump DSR leveraging proven alfapump platform
alfapump DSR® leveraging proven alfapump® platform Fully implanted system for long-term DSR® therapy – keeping patients out of the hospital Sodium-free DSR infusate administered to peritoneal cavity 1 via implanted subcutaneous port 2 Sodium diffuses into DSR infusate 1 3 alfapump pumps sodium-rich
Slide 20: DSR – Encouraging phase 2a heart failure data
DSR® – Encouraging phase 2a heart failure data Clearing congestion while preserving renal function is a key objective of heart failure therapy RED DESERT – Completed SAHARA DESERT – Ongoing (Interim data) 8 Euvolemic heart failure patients 6 Decompensated heart failure patients Safe, effective & rap
Slide 21: Proprietary heart failure drug development programme
Proprietary heart failure drug development programme Red Desert Sahara Desert 2nd Gen. Infusate Mojave Desert Sonoran Desert PoC Ph. 2a ongoing Development Ph. 1b/2a (US) Ph. 2a (US) • 1st Gen. Infusate + • 1st Gen. Infusate + • Animal GLP • 2nd Gen. Infusate • 2nd Gen. Infusate alfapump alfapump
Slide 22: DSR – plan to partner after US efficacy study
DSR® – plan to partner after US efficacy study Step-by-step approach to introduction of breakthrough heart failure therapy 2021 2022 2023 2024 Infusate 1st Gen. - Ph. 2a alfapump DSR® study SAHARA D10% Infusate + alfapump® - Proprietary DSR Infusate 2.0 manufacturing Infusate 2.0 2nd Gen. Infusate -
Slide 23: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 24: Building on our two proprietary platforms
Building on our two proprietary platforms Complementary approaches to diuretic-resistant fluid overload alfapump® alfapump DSR® DSR® Congestive Heart Liver Disease / Failure NASH & Malignant Ascites Long-term Short-term therapy therapy Evaluating Renal Failure Fluid Overload 24 24
Slide 25: Strong outlook for value drivers
Strong outlook for value drivers North American Pivotal Study Liver disease / Q4 21: Q1 22: Q4 22: Mid 23: NASH POSEIDON POSEIDON POSEIDON FDA submission all patients recruited completion alfapump® implants primary endpoint readout for US approval 2021 2022 2023 Heart failure Q4 21: SAHARA H1 22
Slide 26: Strongly positioned for growth in both our markets
Strongly positioned for growth in both our markets • alfapump® in liver disease / NASH – over €3 Bn / year (1) • NASH is changing liver cirrhosis market and driving growth • FDA breakthrough device status / Strong IP portfolio • North American pivotal study de-risked – Fully implanted / Positive int
Slide 27: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Sequana Medical — Needham Healthcare Conference, April 2022 on 6ix