Slide 1: Innovators in the management of fluid overload
Innovators in the management of fluid overload liver disease – malignant ascites – heart failure VFB Happening – 19 September 2020 Ian Crosbie, CEO
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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-a
Slide 3: Disclaimers
Disclaimers Regulatory disclaimer: • The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent asc
Slide 4: Company Overview
Company Overview Founded in 2006 Gent, Belgium (HQ): corporate, clinical, commercial Zurich, Switzerland: manufacturing, engineering, QA/RA ~50 employees Euronext Brussels: SEQUA 4
Slide 5: Shareholders base and financial overview
Shareholders base and financial overview • Cash at 30 June 2020: €14.9M • Debt financing in July 2020: €7.3M • Cash runway into H2 2021 5 5
Slide 6: Unique alfapump platform
Unique alfapump® platform Using the bladder to manage fluid overload 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 Remote data monitoring No sign
Slide 7: One platform – two products
One platform – two products alfapump® alfapump® DSR Liver Disease (NASH) Heart Failure Proven step change in liver refractory ascites Breakthrough approach to fluid overload in and malignant ascites heart failure Over 800 devices implanted Clinical proof-of-concept of Direct Sodium Removal (DSR) > €
Slide 8: NASH drives US market attractiveness
NASH drives US market attractiveness Stronger competitive position in a much larger and dynamic market alfapump® market potential ~€0.4 Bn / year (1) >€3 Bn / year (2) Underlying disease Alcoholic Liver Disease, Hepatitis NASH Patient characteristic “Outside mainstream” “Mainstream” Average age 40-5
Slide 9: Refractory ascites – a key complication of liver cirrhosis
Refractory ascites – a key complication of liver cirrhosis with a dramatic impact on quality of life US forecast ~3-4M (1) Liver “Normal Life” cirrhosis ~5 days High mortality rate Decreased ~1.5M mobility & (2) appetite, Drainage Ascites Extreme discomfort nausea and ~2 days constipation ~5 days Im
Slide 10: alfapump for long-term treatment
alfapump® for long-term treatment Over 800 implants and hundreds of years of patient experience • Reduced burden of disease • Improved patient quality of life • Cost savings for hospitals and payers Breakthrough Device Designation 10 10
Slide 11: POSEIDON – key value inflection points
POSEIDON – key value inflection points North American pivotal study of the alfapump® in recurrent and refractory ascites due to liver cirrhosis Pre-implant Post-implant Post-implant Post-implant observation stabilisation observation long-term follow-up T-3M T0 T+3M T+6M T+24M Enrollment alfapump Pri
Slide 12: alfapump US approval roadmap
alfapump® US approval roadmap Key anticipated milestones 2019 2020 2021 2022 2023 POSEIDON: FDA IDE First Last Interim Primary Secondary approval patient in patient in* analysis* Endpoint Endpoints* Reporting* FDA breakthrough Filing* Approval**, designation Building out followed by US team US
Slide 13: Self-commercialisation in US through specialty salesforce
Self-commercialisation in US through 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) 13 13
Slide 14: Volume overload in heart failure – major clinical problem
Volume overload in heart failure – major clinical problem and key driver of costs US hospitalisations HF – annually due to ~1m 90% hospitalisations HF(1) due to volume overload(1) Excess sodium drives fluid overload c.5d Typical Annual costs of US hospital stay(2) HF-related $13bn hospitalisations(2
Slide 15: Limitations of Diuretic Therapy in Heart Failure
Limitations of Diuretic Therapy in Heart Failure High unmet need for safe and effective chronic treatment solution to treat volume overload Diuretics primarily remove Body retains water and cuts back hypotonic urine on urination to restore homeostasis 40% of heart failure patients on IV loop diure
Slide 16: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Sequana Medical’s breakthrough approach to volume overload in heart failure DSR therapy directly Body eliminates removes the sodium excess fluid “DSR represents a new potential therapy for non-renal sodium and fluid removal in edematous disorders such as heart failure” 16
Slide 17: alfapump DSR
alfapump® DSR Fully implanted system for DSR therapy leveraging proven elements Direct Sodium Removal 1 alfapump Implanted Port 3 Implanted port 2 4 Potential chronic therapy for heart failure patients that are not well controlled on diuretics 17 17
Slide 18: RED DESERT – key value inflection points
RED DESERT – key value inflection points Repeated dose alfapump® DSR study for treatment of diuretic-resistant heart failure patients • Safety: absence/rate of device, procedure and/or therapy related serious adverse events • Feasibility: ability of the alfapump DSR to maintain a neutral sodium bala
Slide 19: alfapump DSR development strategy
alfapump® DSR development strategy Study description 2018 2019 2020 2021 2022 2023 Pre-clinical DSR study in healthy and heart failure induced pigs, single dose Clinical proof-of-concept DSR therapy First in human DSR study: single dose, no alfapump Clinical proof-of-concept alfapump DSR* Part
Slide 20: Expected Core Value Drivers & Outlook
Expected Core Value Drivers & Outlook Liver disease / North America Q1 21: H1 21: Q1 22: NASH in POSEIDON POSEIDON POSEIDON enrolment interim primary endpoint completion results read-out H2 2020 2021 H1 2022 Heart failure in North America Q4 20: H1 21: H2 21: & EU RED DESERT RED DESERT Start US inte
Slide 21: Thank You
Thank You IR@sequanamedical.com +32 498 053579 www.sequanamedical.com