Sequana Medical N.V · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (January 2025)
27 slides from Sequana Medical's investor presentation, January 2025
Slide 1: Pioneers in the treatment of fluid overload
Pioneers in the treatment of fluid overload alfapump approved by FDA for treatment of recurrent and refractory ascites due to liver cirrhosis January 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: Disclaimers (cont'd)
Disclaimers (cont’d) 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
Slide 4: Focus on alfapump US commercialisation
Focus on alfapump US commercialisation Sequana Medical Financing Will be Focused on alfapump® Commercialisation in the US alfapump: DSR • US FDA approved device for recurrent & • Drug development program for cardiorenal refractory ascites due to liver cirrhosis syndrome & diuretic resistance in hear
Slide 5: alfapump
alfapump® FDA Approved Breakthrough Device Targeting $2 billion US Market for Treatment of Recurrent or Refractory Ascites Due to Liver Cirrhosis
Slide 6: Refractory ascites – key complication of liver cirrhosis
Refractory ascites – key complication of liver cirrhosis Fatty liver disease / NASH is driving strong growth and change in attitudes to liver cirrhosis patients Viral infections (Hepatitis B & C) Non-Alcoholic Steatohepatitis Alcoholic Liver Disease (NASH/MASH) Liver Ascites Refractory cirrhosis Asc
Slide 7: SoC Virtually Unchanged for Thousands of Years
SoC Virtually Unchanged for Thousands of Years No new development apart from NASH/MASH drugs, which are not approved in late stage disease SoC: Paracentesis (“drainage”) TIPS Painful, burdensome, short term benefit, QoL impact(1) • Severe Complications & Contraindications (less than 40% eligible)(2)
Slide 8: $2bn US market for alfapump in 2025; 9% CAGR
$2bn US market for alfapump in 2025; 9% CAGR(1) $500 million Priority One market with highly attractive dynamics for the alfapump Recurrent and refractory ascites prevalence (US) 170k 170 155k 150 142k Priority 3(2) 3-5 paracenteses / 130k Prioritisation Factors: 130 year 116k 110 105k • Impact on p
Slide 9: 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 10: US Approval Received – US Launch Planned for H2 25
US Approval Received(1) – US Launch Planned for H2 25 Broad Indication for Use, Minimal Contraindications and No Post Approval Study Requirements The alfapump® system is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicate
Slide 11: 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 s
Slide 12: 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 12 12 Source: POSEIDON data from POSEIDON clinical study report (data on file at Sequana Medical)
Slide 13: alfapump safety profile comparable to standard of care
alfapump safety profile comparable to standard of care Comparison for the six months post-implantation NACSELD-III Registry POSEIDON Pivotal Six month data(1) Matched Patients Cohort(2) Any Death or Hospitalization 45.9% (17/37) 56.8% (21/37) Death 10.8% (4/37) 10.8% (4/37) Hospitalization 35.1% (13
Slide 14: 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 15: US – Go direct to liver transplant centers
US – Go direct to 90 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines Cover 95% of liver transplants Small focused commercial team Source: Organ Procurement & Transplantation Network, US Dept of HHS (optn.transplant.hrsa.gov) 15 15
Slide 16: Strong pricing with derisked reimbursement
Strong pricing with derisked reimbursement Breakthrough device designation and high gross margin Coding – Strong position from existing DRG codes and Breakthrough Designation • Existing US hospital DRG payment for alfapump procedure* • Target alfapump ASP of $30K (80% gross margin) • Breakthrough de
Slide 17: Potential Market Expansion
Potential Market Expansion(1) Opportunities for Additional Indications in Other Significant Markets Malignant Ascites (secondary to cancer) • Breast and ovarian cancer have longest survival with ascites(2) • Severe impact on quality of life • Positive clinical experience in Europe(3) Cardiac Ascites
Slide 18: DSR
DSR® Disease-modifying heart failure drug therapy tackling cardiorenal syndrome (CRS)
Slide 19: Cardiorenal Syndrome – key clinical challenge in HF
Cardiorenal Syndrome – key clinical challenge in HF Clear need for options to tackle congestion for long enough, without the problems of loop diuretics • Combined, and self-reinforcing dysfunction of heart and kidneys with hypothesised complex and interconnected mechanisms • Clinical profile of self
Slide 20: 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) c.5d Typical Annual costs of US
Slide 21: Multi-billion commercial opportunity
Multi-billion commercial opportunity ~400K chronically congested HF patients hospitalized per year in the US and EU (“frequent flyers”) EU US $45K >$9 Bn 200K 200K US annual HF DSR addressable market patients patients hospitalization cost in US per patient Potential for premium DSR pricing through r
Slide 22: 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 23: Clinical proof of concept in cardiorenal syndrome
Clinical proof of concept in cardiorenal sydrome Rapid and effective decongestion PLUS improvement in cardio-renal status Strong results from RED DESERT (N = 8) and SAHARA (n = 10) clinical studies Replacement of loop diuretics; safe, rapid and effective decongestion and maintenance of euvolemia N
Slide 24: Improvement in diuretic response and renal function
Improvement in diuretic response and renal function Normalization of diuretic-response with dramatic durable reduction in LD needs post-DSR therapy Cumulative 6-hour urine output and urinary sodium excretion Blood urea nitrogen (BUN) and following an intravenous 40mg dose of furosemide creatinine cl
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
Slide 26: Innovating DSR Access to Expand Market Opportunity
Innovating DSR Access to Expand Market Opportunity Four weeks of outpatient therapy targeting long term benefit Treatment Overview • Expected to be 2-3x per week, for 4 weeks • DSR infused at doctors office / outpatient, ~30 minutes session • After dwell (12 – 24 hours as directed), patient drains a
Slide 27: 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
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