Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Oppenheimer Healthcare Conference 2022
27 slides from Sequana Medical's conference presentation, Mar 17, 2022
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Euronext: SEQUA.BR Oppenheimer Healthcare Conference – 17 March 2022 Ian Crosbie, CEO 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 changing liver cirrhosis market and driving growth • Approved in EU / FDA breakthrough designation in US • US pivotal study fully enrolled / positive interim data / primary endpoint Q4 ‘22 • Direct c
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 up to 50 implanted patients; Roll-In (“training”) cohort of up to 40 patients alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months 18 months Pre-implant Post-implant Post-implant Post-implan
Slide 12: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from 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) SAFET
Slide 13: Pursuing North American alfapump approval
Pursuing North American alfapump® approval 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 population
Slide 14: US commercialisation through our specialty salesforce
US commercialisation through our specialty salesforce NY MI (7) (4) PA (12) OH Initial focus on key IL (6) (6) CA transplant centres (12) NC (3) ~50-person team: AZ (5) 35 sales reps, 10 clinical, GA (3) 5 corporate TX (13) FL (8) POSEIDON site Target State (# transplant centres) 14 14
Slide 15: DSR
DSR ® Breakthrough approach to persistent congestion in heart failure leveraging proven alfapump® platform
Slide 16: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Clear unmet clinical need and driver of costs for heart failure patients 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-related $13bn hospitalisations(
Slide 17: 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 18: 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 19: RED DESERT: Successful Proof-of-Concept Study
RED DESERT: Successful Proof-of-Concept Study 8 euvolemic heart failure patients on high dose diuretics treated with DSR 3x per week up to 6 weeks Highly effective management of fluid and sodium balance • Generally safe and well tolerated; no clinically relevant hyponatremia Significant improvement
Slide 20: SAHARA DESERT: Ph. 2A in target patient population
SAHARA DESERT: Ph. 2A in target patient population 20 decompensated heart failure patients with persistent congestion on high dose diuretics – ongoing Patient Start 1st Gen Euvolemic End DSR enrolment DSR® therapy state therapy Phase 1: Phase 2: Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive
Slide 21: SAHARA DESERT: Ph. 2A positive interim data
SAHARA DESERT: Ph. 2A positive interim data Indication of strong safety and efficacy in 6 patients Safe, effective and rapid elimination of persistent congestion and restoration of euvolemia without any loop diuretics • Mean weight loss of ~6kg (=7% of body weight) vs. baseline Considerable benefit
Slide 22: 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 23: DSR – plan to partner after US efficacy study
DSR® – plan to partner after US efficacy study Step-by-step approach to introduction of breakthrough therapy in decompensated HF patients 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
Slide 24: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 25: 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 25 25
Slide 26: 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 27: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
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