Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Jefferies London Healthcare Conference 2021
28 slides from Sequana Medical's conference presentation, Nov 16, 2021
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Jefferies London Healthcare Conference Ian Crosbie, CEO – 16 November 2021 Innovators in the treatment of diuretic-resistant fluid overload liver disease – malignant ascites – heart failure
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 ongoing SAHARA
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: alfapump
alfapump ® Proven step change in the treatment of liver refractory ascites and malignant ascites
Slide 9: 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 10: 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 11: 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 11 Designation 11
Slide 12: North American Pivotal Study (POSEIDON) underway
North American Pivotal Study (POSEIDON) underway Pivotal Cohort of up to 50 implanted patients alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months 18 months Pre-implant Post-implant Post-implant Post-implant observation stabilisation observation long-term
Slide 13: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from 26 Roll-In (“training”) patients having a similar profile as Pivotal patients EFFICACY Over 90% reduction in mean Therapeutic Paracentesis (TP) frequency (primary endpoint >50% reduction) 100% patients with > 50% reduction in mean TP fre
Slide 14: 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 P
Slide 15: 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) 15 15
Slide 16: alfapump DSR
alfapump DSR ® Breakthrough approach to persistent congestion in heart failure built on proven alfapump® platform
Slide 17: 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 18: 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 19: 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 20: Persistent congestion and Worsening renal function
Persistent congestion and Worsening renal function Key drivers of mortality in decompensated heart failure Wattad et al, American Journal of Cardiology, 2015: interaction between worsening renal function and persistent congestion in acute decompensated heart failure (study of 762 patients) WRF: Wors
Slide 21: 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 22: 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 23: 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 24: 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 25: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 26: 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 26 26
Slide 27: Strong outlook for value drivers
Liver disease / Strong outlook for value drivers Q4 21: Q4 22: Mid 23: NASH POSEIDON POSEIDON FDA submission all patients recruited primary endpoint readout for US approval 2021 2022 2023 Heart failure Q4 21: H2 22: H2 22: Mid 23: H2 23: SAHARA SAHARA MOJAVE MOJAVE SONORAN interim results top-line r
Slide 28: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Sequana Medical — Jefferies London Healthcare Conference 2021 on 6ix