Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H.C. Wainwright BioConnect Virtual Conference 2022
25 slides from Sequana Medical's conference presentation, Jan 10, 2022
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
H.C. Wainwright BioConnect Virtual Conference Ian Crosbie, CEO – 10 January 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: Treating diuretic-resistant fluid overload
Treating diuretic-resistant fluid overload Multi billion € markets with clear unmet clinical needs • Fluid overload is a key clinical problem in liver failure, heart failure, renal failure and cancer • Diuretics are standard of care – we are NOT replacing these • Diuretic-resistance is common – and
Slide 4: alfapump platform
alfapump® platform 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-cl
Slide 5: 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 6: Focus on two products – € billion opportunities
Focus on two products – € billion opportunities alfapump® alfapump DSR® Liver Disease (NASH) in N. America Congestion due to Heart Failure > €3 Bn / year market opportunity in US(1) > €5 Bn / year market opportunity in EU & US(2) Breakthrough Device Designation POSEIDON pivotal study enrolment compl
Slide 7: NASH drives US market attractiveness
NASH drives US market attractiveness Liver cirrhosis is transitioning to a mainstream disease requiring modern treatment options alfapump® market potential ~€0.4 Bn / year >€3 Bn / year Underlying disease Alcoholic Liver Disease, Hepatitis NASH Patient characteristic “Outside mainstream” “Mainstream
Slide 8: 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 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 for long-term treatment
alfapump® for long-term treatment Over 850 implants and hundreds of years of patient experience Reduce burden of disease Improve patient quality of life Reduce cost Breakthrough Device 10 Designation 10
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: 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 16: alfapump DSR leveraging proven alfapump platform
alfapump DSR® leveraging proven alfapump® platform Fully implanted system for long-term DSR® therapy 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 DSR infusate into the bladder 3 Body el
Slide 17: RED DESERT: repeated dose alfapump DSR study
RED DESERT: repeated dose alfapump DSR® 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 18: SAHARA DESERT: Targeting persistent congestion
SAHARA DESERT: Targeting persistent congestion 20 decompensated heart failure patients with persistent congestion on high dose diuretics – ongoing Patient Start DSR® Euvolemic End DSR enrolment therapy state therapy Phase 1: Phase 2: Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive DSR therapy
Slide 19: Interim 1 SAHARA DESERT: Indication of strong safety & efficacy results
Interim1 SAHARA DESERT: Indication of strong safety & efficacy results 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 in cardio-renal status • Red
Slide 20: Proprietary DSR Infusate 2.0 drives value model
Proprietary DSR® Infusate 2.0 drives value model • D10% used as initial DSR infusate for fastest proof-of-concept • We are developing our proprietary next-generation DSR infusate Improved therapeutic profile IP protection Recurring revenue from high gross margin consumable 20 20
Slide 21: Short-term DSR – Derisking & extending franchise
Short-term DSR® – Derisking & extending franchise Simplifying regulatory path and preparing market for alfapump DSR® market entry Short-term DSR – “drug only” Long-term alfapump DSR – “drug / device” • “one off” ~2 weeks intensive DSR treatment • Intermittent, recurring, intensive DSR treatment • Wi
Slide 22: DSR – Robust development program
DSR® – Robust development program* Step-by-step approach to introduction of breakthrough therapy 2021 2022 2023 2024 - alfapump DSR® feasibility study SAHARA D10% infusate; decompensated heart failure patients - Proprietary DSR infusate 2.0 manufacturing DSR Infusate 2.0 - GLP animal study (chronic
Slide 23: 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 23 23
Slide 24: Strong outlook for value drivers
Liver disease / Strong outlook for value drivers 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: H1 22: H2 22: H2 22: Mid 23: H2 23: SAHAR
Slide 25: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Sequana Medical — H.C. Wainwright BioConnect Virtual Conference 2022 on 6ix