Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (June 2025)
24 slides from Sequana Medical's investor presentation, June 2025
Slide 1: Pioneers in the treatment of fluid overload
Pioneers in the treatment of fluid overload alfapump® - FDA approved breakthrough device targeting underserved $2 billion US market June 2025 Euronext: SEQUA.BR
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: Focus on alfapump commercialisation in the US
Focus on alfapump commercialisation in the US Sequana Medical Financing Will be Focused on alfapump® Commercialisation in the US Primary Focus – alfapump US commercialisation • US FDA approved device for recurrent & refractory ascites due to liver cirrhosis • Potential to transform underserved $2 bi
Slide 4: alfapump
alfapump® FDA Approved Breakthrough Device Targeting Underserved $2 billion US Market
Slide 5: Refractory ascites – key complication of liver cirrhosis
Refractory ascites – key complication of liver cirrhosis MASH / NASH is driving strong growth in number of liver cirrhosis patients, and changing attitudes Viral infections (Hepatitis B & C) Alcohol Obesity (Alcoholic Liver (NASH/MASH)(1) Disease) Liver Ascites Refractory cirrhosis Ascites (1) Non-a
Slide 6: SoC Virtually Unchanged for Thousands of Years
SoC Virtually Unchanged for Thousands of Years No medtech innovation foreseen; NASH/MASH drugs are not approved in liver cirrhosis SoC: Paracentesis (“drainage”) Painful, burdensome, short term benefit, QoL impact(1) TIPS “Normal Life” • Severe Complications & Contraindications (less than 40% eligib
Slide 7: $2 billion US market for alfapump and 9% CAGR
$2 billion US market for alfapump and 9% CAGR(1) Forecast to reach over $5 billion by 2035 – with strong barriers to entry for new competition Recurrent and refractory ascites prevalence (US) 180 170k 155k 160 142k 140 130k 116k 120 105k 96k 100 88k Patients (thousands) 81k 75k 80 70k 60 40 20 0 202
Slide 8: Proven step change in therapy, over 1,000 implanted
Proven step change in therapy, over 1,000 implanted Fully implanted automatic device for long term treatment Wireless battery charging Settings wirelessly adjusted Automatic Operation Long-term implantation Regular reporting to clinicians Integrated pressure sensors Breakthrough Device (2) PMA Appro
Slide 9: US Approval Received – US Launch Planned for Q3 25
US Approval Received(1) – US Launch Planned for Q3 25 Broad Indication for Use & No Post Approval Study Supports Effective Commercialisation The alfapump® system is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for
Slide 10: POSEIDON: Successful North American pivotal study
POSEIDON: Successful North American pivotal study Pivotal Cohort of 40 patients with recurrent or refractory ascites due to liver cirrhosis alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant st
Slide 11: POSEIDON: Overall survival favourable over SoC
POSEIDON: Overall survival favourable over SoC Higher Than Expected in this Patient Population (compared to LVP), Comparable to TIPS Source: POSEIDON data from POSEIDON clinical study report (data on file at Sequana Medical) Note: The data in this chart is combined from different studies and does no
Slide 12: POSEIDON: robust safety profile
POSEIDON: robust safety profile In line with expectations for this patient population and comparable to standard of care Primary safety endpoint data in line with expectations (0 - 6 months) • No unanticipated adverse device effects • MAE rate comparable to baseline, and aligns with general decompen
Slide 13: alfapump profile exceeding patient expectations
alfapump profile exceeding patient expectations Patient preference study indicates compelling profile for alfapump based on POSEIDON outcomes Patient preference study POSEIDON pivotal cohort Risk tolerance (over 6 months) Maximum acceptable risk Observed rate Major surgery or death >10% 0% Minor pro
Slide 14: Direct salesforce targeting liver transplant centers
Direct salesforce targeting 90 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines Cover 90% of liver transplants Small focused commercial team • Commercial sales planned to start mid Q3 • Initial launch this year at six centers • Full l
Slide 15: Attractive pricing based on derisked reimbursement
Attractive pricing based on derisked reimbursement Breakthrough device designation and high gross margin Coding – Strong position from existing DRG codes and Breakthrough Designation • Hospital reimbursement codes granted - existing DRG’s for alfapump procedure* • Breakthrough designation enables hi
Slide 16: Potential Market Expansion
Potential Market Expansion(1) Opportunities for Additional Indications in Other Significant Markets Malignant Ascites: Fluid in peritoneal cavity due to cancer Cardiac Ascites: Very similar presentation to liver cirrhosis Pleural Effusion: Fluid in the chest cavity 1: Not included in current US indi
Slide 17: R&D Pipeline: DSR
R&D Pipeline: DSR® Clinical Proof-of-Concept for Disease- Modifying Drug Program Targeting Key Unmet Needs in Heart Failure
Slide 18: Cardiorenal Syndrome – key clinical challenge in HF
Cardiorenal Syndrome – key clinical challenge in HF Unmet clinical need to tackle congestion for long enough, without the problems of loop diuretics • Combined, and self-reinforcing negative feedback dysfunction of heart and kidneys with hypothesised complex and interconnected mechanisms Sodium Hear
Slide 19: Congestion is key driver of morbidity & hospitalization
Congestion is key driver of morbidity & hospitalization Diuretic-resistance in heart failure is common; no “super-diuretics” in development US hospitalizations HF hospitalizations annually due to ~1m 90% due to fluid overload heart failure (HF)(3) (AKA congestion)(3) EU US 200K 200K Patients(6) Pati
Slide 20: DSR (Direct Sodium Removal) targets key driver
DSR (Direct Sodium Removal) targets key driver Validated by RED DESERT, SAHARA & MOJAVE clinical studies, with peer-reviewed publication 1 Sodium-free DSR product 2 Sodium diffuses from 3 DSR product + extracted 4 Body eliminates free water administered to peritoneal body into DSR product sodium & w
Slide 21: Clinical proof of concept in cardiorenal syndrome
Clinical proof of concept in cardiorenal sydrome Strong results from RED DESERT (n = 8) and SAHARA (n = 10) clinical studies – published in EJHF Safe, rapid and effective elimination of excess fluid and maintenance of euvolemia Normalization of response to diuretics Long lasting reduction in loop
Slide 22: Breakthrough in kidney response and LD requirement
Breakthrough in kidney response and LD requirement Published in European Journal of Heart Failure, May 2024 Cumulative 6-hour urine output and urinary sodium excretion following an intravenous 40mg dose of furosemide Blood urea nitrogen (BUN) and creatinine clearance Oral loop diuretic dose over the
Slide 23: MOJAVE: Phase 1/2a randomized controlled US study
MOJAVE: Phase 1/2a randomized controlled US study Seeking to replicate RED DESERT and SAHARA positive results in US patients 4 weeks 3 months (initial follow-up at 30 days) DSR therapy (up to daily) + optimized usual care vs. Safety follow-up period IV loop diuretic + optimized usual care Non-random
Slide 24: Highly experienced leadership team
Highly experienced leadership team Derisking US commercial roll-out, and leveraging extensive board experience Executive team: Gijs Klarenbeek Martijn Blom Ian Crosbie Kirsten Van Bockstaele Chief Commercial Officer Chief Executive Officer Chief Financial Officer Chief Medical Officer Dragomir Lakic