Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H.C. Wainwright Global Investment Conference (May 2022)
27 slides from Sequana Medical's conference presentation, May 18, 2022
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Euronext: SEQUA.BR H.C. Wainwright Global Investment Conference Ian Crosbie, CEO – May 2022 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 • 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 Study – POSEIDON Liver disease / Q4 21: Q1 22: NASH Q4 22: Mid 23: all patients recruited completion alfapump® implants primary endpoint readout FDA submission for US approval 2021 2022 2023 Heart failure Q4 21: interim results Q2 22: all patients r
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 Long-te
Slide 12: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from first 26 Roll-In patients clinically derisks the study 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 (prima
Slide 13: Interim POSEIDON: 70% survival at 12 months
Interim POSEIDON: 70% survival at 12 months* Compares favourably to published literature Published literature cited in AASLD practice guidelines: survival rate for refractory ascites patients of only 50% at 12 months1 *Preliminary survival rate analysis of Roll-In Cohort (25 March 2022) 13 13 Source
Slide 14: North American alfapump approval on track for 2024
North American alfapump® approval on track 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 rei
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 ~50 initially - 35 sales reps - 10 clinical specialists - 5 corporate 15 15
Slide 16: DSR: Breakthrough approach to heart failure
DSR® Breakthrough approach to heart failure
Slide 17: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Removal of congestion without damaging renal function is a key therapeutic target and 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 Clinical Proof-of-Concept demonstrating breakthrough potential in heart failure therapy RED DESERT – Completed SAHARA DESERT – Ongoing (Interim data) 8 Euvolemic heart failure patients 6 Decompensated heart failure patients Safe & effective management o
Slide 21: Moving to proprietary 2nd Generation Infusate
Moving to proprietary 2nd Generation Infusate Red Desert Sahara Desert 2nd Gen. Infusate Mojave Desert Sonoran Desert PoC Ph. 2a ongoing Development Ph. 1b/2a (US) Ph. 2a (US) • alfapump DSR • alfapump DSR • Animal GLP • Short-Term DSR • alfapump DSR • 8 euvolemic HF • Up to 20 and CMC data (no al
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. - Phase 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 Study – POSEIDON Liver disease / Q4 21: Q1 22: NASH Q4 22: Mid 23: all patients recruited completion alfapump® implants primary endpoint readout FDA submission for US approval 2021 2022 2023 Heart failure Q4 21: interim results Q2 22: all patients r
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
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