Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (September 2025)
25 slides from Sequana Medical's investor presentation, September 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 September 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: FDA Approved Device Transforming Large Neglected Market
FDA Approved Device Transforming Large Neglected Market • Large Existing Market • $2 billion US market, growing at 9% CAGR • Long term growth driven by obesity and demand for better treatments • Differentiated Solution: alfapump® addresses unmet clinical need • Physicians and patients want a better
Slide 4: Ascites – key complication of liver cirrhosis
Ascites – key complication of liver cirrhosis Painful build-up of fluid in the abdomen leading to severe clinical problems and quality of life impact Viral infections (Hepatitis B & C) Alcohol Obesity (Alcoholic Liver (NASH/MASH)(1) Disease) Liver Ascites cirrhosis Recurrent or refractory ascites 4
Slide 5: $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 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 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035
Slide 6: Current treatments have clear clinical limitations
Current treatments have clear clinical limitations Drainage and TIPS are the main treatment options; alfapump is the only innovation, nothing in development SoC (1) : Paracentesis (“drainage”) Painful, burdensome, short-term benefit, QoL impact (2) TIPS (“bypass”) “Normal Life” • Less than 40% of pa
Slide 7: Proven step change in therapy, over 1,000 implanted
Proven step change in therapy, over 1,000 implanted Automatic pumping of ascites from peritoneal cavity to the bladder where it is urinated away Full implanted Wireless charging Settings wirelessly adjusted Automatic Operation Long-term implantation Regular reporting to clinicians Integrated pressur
Slide 8: FDA Approved & US Launch Underway
FDA Approved(1) & US Launch Underway 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 the removal of e
Slide 9: Successful North American pivotal study (POSEIDON)
Successful North American pivotal study (POSEIDON) 100% median reduction in therapeutic paracentesis plus important improvement in QoL alfapump Primary Secondary Enrolment implantation endpoint ✓ endpoints ✓ 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant stabilisati
Slide 10: 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 alfapump(1) 1 Alfapump data from POSEIDON Pivotal Cohort mITT 10 10 Source: POSEIDON data from POSEIDON clinical study report (data on file at Sequana Medical)
Slide 11: POSEIDON: additional Good Health Days / month
POSEIDON: 10 additional “Good Health Days” / month What it really means to the patient Negative Negative Positive 17 days / month Positive 27 days / month Before alfapump (n=32) With alfapump (n=16) Source: alfapump system SSED (summary of safety and effectiveness) PMA 230044 Good Health Day: Patien
Slide 12: Smart US commercial strategy underway
Smart US commercial strategy underway Initial Focus on Non-TIPS market, and Transplant Centers Non-TIPS Market Transplant Centers • Majority of the market • 90 centers cover 90% of liver transplants • Clear unmet needs • Small focused commercial team • Limited competition / low entry barriers • Cent
Slide 13: Solid reimbursement supports $30K+ ASP
Solid reimbursement supports $30K+ ASP NTAP and granted hospital procedure codes support $33K ASP Coding & Payment – Strong position from existing DRG codes and NTAP • Hospital reimbursement codes granted (existing DRG’s for alfapump procedure(1)) • NTAP additional reimbursement approved commencing
Slide 14: Compelling commercial opportunity
Compelling commercial opportunity Potential to disrupt the non-TIPS market with little pushback expected Physicians Are Looking for Better Options for their Non-TIPS patients • When TIPS is i) not an option, ii) has failed or iii) when patient is concerned about cognitive risk • Potential to drive a
Slide 15: Positioned for sustainable market leadership
Positioned for sustainable market leadership PMA & Breakthrough Device Designation Creates Major Barriers to Entry for Followers IP: Granted US patent protection through 2036 PMA: (granted to alfapump system) • Does not create 510(k) pathway; requires ownership of data so our data & studies cannot b
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 indic
Slide 17: Highly experienced leadership team
Highly experienced leadership team Derisking US alfapump commercial roll-out, and leveraging extensive board experience Executive team: Martijn Blom Gijs Klarenbeek Ian Crosbie Kirsten Van Bockstaele Chief Medical Officer Chief Executive Officer Chief Financial Officer Chief Commercial Officer Drago
Slide 18: FDA Approved Device Transforming Large Neglected Market
FDA Approved Device Transforming Large Neglected Market • Large Existing Market • $2 billion US market, growing at 9% CAGR • Long term growth driven by obesity and demand for better treatments • Differentiated Solution: alfapump® addresses unmet clinical need • Physicians and patients want a better
Slide 19: R&D Pipeline: DSR
R&D Pipeline: DSR® Clinical Proof-of-Concept Drug Program Targeting Key Unmet Needs in Heart Failure
Slide 20: Cardiorenal Syndrome – key clinical challenge in HF
Cardiorenal Syndrome – key clinical challenge in HF Unmet clinical need to tackle congestion for long enough, without damaging effect of loop diuretics • Heart and kidneys are a closely linked, dependent system • Poor cardiac output leads to retention of sodium by kidneys, increasing fluid volume to
Slide 21: 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 patient
Slide 22: DSR targets key driver of congestion – Sodium overload
DSR targets key driver of congestion – Sodium overload 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 so
Slide 23: Clinical proof of concept in cardiorenal sydrome
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 fluid balance ✓Restores normal response of kidneys to diuretics ✓Long lasting red
Slide 24: 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 25: 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
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