Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H.C. Wainwright 23rd Annual Global Investment Conference 2021
21 slides from Sequana Medical's conference presentation, Sep 13, 2021
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Innovators in the treatment of diuretic-resistant fluid overload liver disease – malignant ascites – heart failure H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021 – Ian Crosbie, CEO
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: Disclaimers
Disclaimers Regulatory disclaimer: • The alfapump® system has not yet received regulatory approval in the United States and Canada. Any statement in this presentation about safety and efficacy of the alfapump® system does not apply to the United States and Canada. In the United States and Canada, th
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: Key Principle
Direct Sodium Removal (DSR®) platform Eliminating fluid spread across the body – working in partnership with the kidneys Key Principle Excess fluid in balance DSR removes the sodium – Body eliminates excess with excess sodium disrupts the equilibrium fluid to restore the balance How It Works Sodium-
Slide 6: Two pillars of growth – € billion opportunities
Two pillars of growth – € billion opportunities alfapump® alfapump DSR® Liver Disease (NASH) Heart Failure Proven step change in liver refractory ascites Breakthrough approach to diuretic-resistant congestion and malignant ascites Proven ability to manage fluid balance, restore diuretic Over 850 dev
Slide 7: NASH drives US liver ascites market attractiveness
NASH drives US liver ascites market attractiveness Stronger competitive position in a much larger and dynamic market alfapump® market potential ~€0.4 Bn / year >€3 Bn / year Underlying disease Alcoholic Liver Disease, Hepatitis NASH Patient characteristic “Outside mainstream” “Mainstream” Average ag
Slide 8: Refractory liver ascites
Refractory liver ascites A key complication of liver cirrhosis, with a dramatic impact on quality of life US forecast ~3-4M (1) Viral infections Liver (Hepatitis B & C) “Normal Life” cirrhosis ~5 days ~1.5M Decreased (2) High mortality rate mobility & Alcoholic Liver appetite, Ascites Drainage Disea
Slide 9: 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 30 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 10: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from 26 Roll-In patients EFFICACY Substantial and durable reduction in Therapeutic Paracentesis (TP) Over 90% reduction in mean frequency of TP post- vs. pre-implant (primary endpoint of >50% reduction) 100% patients with > 50% reduction in
Slide 11: Pursuing North American alfapump approval
Pursuing North American alfapump® approval • POSEIDON – Submitted protocol amendment to FDA to extend patient enrolment due to the higher attrition rate between enrolment and implantation • PMA – Submission for regulatory approval expected mid-2023 • Reimbursement – CMS support for breakthrough devi
Slide 12: 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) 12 12
Slide 13: Targeting diuretic-resistant congestion
Targeting diuretic-resistant congestion Clear unmet 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) Excess sodium drives c.5d Typical fluid overload Annual costs of US hospital stay(4) HF-related $13
Slide 14: 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 1 peritoneal cavity via implanted port 2 Sodium diffuses into DSR infusate 1 alfapump pumps sodium-rich DSR infusate into the 3 bladder 3 Body eliminates exce
Slide 15: RED DESERT: repeated dose alfapump DSR study
RED DESERT: repeated dose alfapump DSR® study Eight euvolemic heart failure patients on high dose diuretics Highly effective management of fluid and sodium balance • DSR treatment 3x per week for up to 6 weeks • Generally safe and well tolerated; no clinically relevant hyponatremia Dramatic and long
Slide 16: 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 Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive DSR therapy Maintenance DSR th
Slide 17: 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 protected Recurring revenue from high gross margin consumable Note: This image is
Slide 18: Short-term DSR – Derisking & extending franchise
Short-term DSR® – Derisking & extending franchise Simplifying Regulatory Process and Preparing for alfapump DSR market entry Short-term DSR therapy: Long-term alfapump DSR® therapy: • “one off” ~2 weeks intensive DSR treatment • Intermittent, recurring, intensive DSR treatment • With peritoneal cath
Slide 19: 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 s
Slide 20: Strong outlook for value drivers
Liver disease / Strong outlook for value drivers Q2 21: TBD*: TBD*: NASH POSEIDON POSEIDON POSEIDON interim analysis LPI primary endpoint 2021 2022 Heart failure Q2RED 21: Q2 21: SAHARA Q4 21: SAHARA H2 22: SAHARA H2 22: MOJAVE DESERT DESERT DESERT DESERT DESERT top-line results FPI interim resu
Slide 21: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
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