Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Corporate Update (January 2025)
47 slides from Sequana Medical's corporate update, Jan 8, 2025
Slide 1: US Commercial Roll-Out of alfapump System
US Commercial Roll-Out of alfapump® System KOL Webinar January 8, 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: Presenters
Presenters alfapump® US commercialisation plans Ian Crosbie Dr Klarenbeek Martijn Blom Dr Saab Dr Pagadala Chief Executive Officer Chief Medical Officer Chief Commercial Officer Professor of Medicine Transplant Sequana Medical NV Sequana Medical NV Sequana Medical NV & Surgery, Hepatologist, David G
Slide 5: US Commercial Roll-Out of alfapump
US Commercial Roll-Out of alfapump® Introduction Ian Crosbie, CEO Recurrent and Refractory Ascites Due to Liver Cirrhosis – Dr Saab, Overview and treatment overview UCLA POSEIDON & Patient Preference Studies Dr Gijs Klarenbeek, Chief Medical Officer What the POSEIDON results mean for patients and ph
Slide 6: Introduction
Introduction Ian Crosbie, CEO 6
Slide 7: 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 heart
Slide 8: alfapump – highly attractive US opportunity
alfapump – highly attractive US opportunity US PMA approval in large and growing market with attractive dynamics and direct specialty sales model • Recurrent and Refractory Liver Ascites - $2 billion market with 9% CAGR driven by MASH/NASH & alcoholic liver disease • Potential to Transform Underserv
Slide 9: 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 10: 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 11: Recurrent and Refractory Ascites Due to Liver Cirrhosis
Recurrent and Refractory Ascites Due to Liver Cirrhosis – overview and treatment options Dr Saab, UCLA 11
Slide 12: Cirrhosis - Epidemiology
Dr. Saab, UCLA Cirrhosis - Epidemiology • Affects ~2.2 million adults in US1 • Continues to rise due to increased incidence of alcohol liver disease and steatotic liver disease • > 40,000 progress to liver failure and death each year2 12 1. Tapper and Parikh 2023; 2. NIAAA surveillance report 2022
Slide 13: Ascites is a main complication of cirrhosis
Dr. Saab, UCLA Ascites is a main complication of cirrhosis Cirrhosis Portal Hypertension Additional complications Hepatic encephalopathy (HE) Gastrointestinal/variceal bleeding Ascites Circulatory failure Acute Kidney Inury Spontaneous Dilutional Infections (AKI) / Hepatorenal Hyponatremia (e.
Slide 14: Unmet need for effective treatment to reduce need for repeated invasive procedures
Dr. Saab, UCLA Unmet need for effective treatment to reduce need for repeated invasive procedures • Patients continue to suffer debilitating symptoms and poor QoL • One-year mortality is high so QoL is key in evaluation of therapeutic interventions Need effective treatment that will reduce need for
Slide 15: Patients with ascites suffer debilitating symptoms & poor quality of life
Dr. Saab, UCLA Patients with ascites suffer debilitating symptoms & poor quality of life Perceived stigma associated with adverse Early satiety, Frailty, attitudes and behaviors1 anorexia, sarcopenia nausea Increased depression Withdrawal Infection from society risk Caregiver Burden2,3 Provide t
Slide 16: Survival in patients with refractory ascites declines rapidly
Dr. Saab, UCLA Survival in patients with refractory ascites declines rapidly 1.0 Transjugular Intrahepatic 0.8 Portosystemic shunt (TIPS) 0.6 61% Proportion Surviving 0.4 Large Volume Paracentesis 40% (LVP) 0.2 0.0 0 120 240 360 480 600 720 At risk Days TIPS 169 138 125 114 83 77 72 SOC 104 84 73 61
Slide 17: Treatment options for recurrent / refractory ascites
Dr. Saab, UCLA Treatment options for recurrent / refractory ascites ONLY Liver transplant CURE FIRST Large Volume Paracentesis (> 5L) LINE SECOND Transjugular intrahepatic portosystemic shunt (TIPS) LINE 17
Slide 18: LVP is first-line treatment
Dr. Saab, UCLA LVP is first-line treatment • Direct aspiration of > 5 L of ascites1 • Invasive, time consuming, and costly • In-hospital or outpatient clinic • Simultaneous administration with IV albumin solution1 • Risk of paracentesis-induced circulatory dysfunction (PICD)2 • Severe complication a
Slide 19: TIPS is Second-Line Treatment but Many Patients Are Not Eligible
Dr. Saab, UCLA TIPS is Second-Line Treatment but Many Patients Are Not Eligible for the Procedure • Less than 40 % are eligible for TIPS1 • Some eligible patients refuse TIPS due to high risk of hepatic encephalopathy Relative Contraindications Absolute Contraindications Advanced age Severe or poorl
Slide 20: Other Secondary Treatment Options are Limited and Negatively impact QoL
Dr. Saab, UCLA Other Secondary Treatment Options are Limited and Negatively impact QoL • Indwelling external drains • Only SoC in patients with < 6 months to live due to tendency for infection1 • Permanent catheter • Risk for infection, limits daily activities, stigma (stick out of skin, can’t get w
Slide 21: Summary
Dr. Saab, UCLA Summary • Treatment of recurrent or refractory ascites is major unmet need in medicine • Treatment options are limited: • Repeat paracentesis associated with risks of infection, bleeding, and organ puncture • TIPS can be associated with precipitation or worsening of hepatic encephalop
Slide 22: POSEIDON & Patient Preference Studies
POSEIDON & Patient Preference Studies Dr Gijs Klarenbeek, Chief Medical Officer 22
Slide 23: Implant procedure
Implant procedure Percutaneous Procedure in 60 – 90 minutes • Interventional Radiology (IR) procedure • Straightforward procedure with short learning curve • Standard percutaneous techniques • Performed in standard IR suite – standard IR equipment • Local or general anesthesia (patient/physician pre
Slide 24: POSEIDON - Successful North American pivotal study
POSEIDON - Successful North American pivotal study Pivotal Cohort of 40 implanted 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
Slide 25: Impact on patient reported Good Health Days
Impact on patient reported “Good Health Days” In a true patient perspective Negative Negative Positive 17 days / month Positive 27 days / month Pre-Implant (n=32) Post-Implant (n=16) Source: alfapump system SSED (summary of safety and effectiveness) PMA 230044 Good Health Day: Patient reported posit
Slide 26: Primary safety endpoint through six months consistent with expected rate
Primary safety endpoint through six months consistent with expected rate Patients with Events Primary Safety Endpoint N = 34* Through 6 months post implant Events n (%) 95% CI Primary safety endpoint 6 6 (18%) (6.8, 34.5) Open surgical re-intervention 0 0 (0.0, 10.3) Pump explant without 6 6 (18%) (
Slide 27: 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 28: POSEIDON Overall Survival
POSEIDON Overall Survival Not a powered endpoint; Pre-specified per protocol analysis – Kaplan Meier 28 28 Source: POSEIDON clinical study report (data on file at Sequana Medical)
Slide 29: 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 29 29 Source: POSEIDON clinical study report (data on file at Sequana Medical)
Slide 30: 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 31: 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 32: What the POSEIDON data means for US patients and physicians
What the POSEIDON data means for US patients and physicians & Experiences from the POSEIDON study Dr Pagadala, Methodist Dallas Medical Center 32
Slide 33: Effectiveness demonstrated in POSEIDON
Dr. Pagadala, Methodist Dallas Medical Center Effectiveness demonstrated in POSEIDON Impact on patients – caregivers – physicians / hospital 33 33 Source: POSEIDON clinical study report (data on file at Sequana Medical)
Slide 34: Impact on Quality of Life
Dr. Pagadala, Methodist Dallas Medical Center Impact on Quality of Life Patient Perspective beyond numbers as outcome of a Questionnaire 34 34 Source: POSEIDON clinical study report (data on file at Sequana Medical)
Slide 35: Safety - Complications
Dr. Pagadala, Methodist Dallas Medical Center Safety - Complications As expected for this patient population – manageable 35 35 Source: POSEIDON clinical study report (data on file at Sequana Medical)
Slide 36: Center Experience
Dr. Pagadala, Methodist Dallas Medical Center Center Experience From POSEIDON clinical study • Build alfapump Team • Collaboration between departments • Hepatology • Interventional Radiology • Other Medical and Paramedical Staff • Learning curve • Implantation – early post-implant period • Long term
Slide 37: US Market Opportunity & Commercial Roll-Out Plans
US Market Opportunity & Commercial Roll-Out Plans Martijn Blom, Chief Commercial Officer 37
Slide 38: $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 39: Attractive pricing with derisked reimbursement
Attractive pricing with derisked reimbursement Existing DRG & CPT III codes - NTAP and TCET benefit from Breakthrough Device Designation Coding – Strong position from existing DRG codes and Breakthrough Designation • Existing US hospital DRG payment for alfapump procedure* • Breakthrough designation
Slide 40: 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) 40 40
Slide 41: Commercial Roll-Out – Focus on High Quality Outcomes
Commercial Roll-Out – Focus on High Quality Outcomes Driven by product availability, recruitment / training of Sequana team and onboarding of new sites • “Soft Commercial Launch”: H2 2025 – Q1 2026 • Limited initial production availability of key supplier; forecasting 80-100 systems available • Targ
Slide 42: PMA & Breakthrough Device Designation Are Key
PMA & Breakthrough Device Designation Are Key Combination creates real challenges to entry of competing products PMA: (granted to alfapump system in 2024) • Evaluation of safety and efficacy of Class III devices; most stringent regulatory category – technical, non-clinical and clinical components •
Slide 43: Wrap-Up
lan Crosbie, CEO sequanamedical
Slide 44: Highly experienced leadership team
Highly experienced leadership team Supported by committed shareholders 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 Timur Resch Andreas Wirth VP Manufactur
Slide 45: alfapump – highly attractive US opportunity
alfapump – highly attractive US opportunity US PMA approval in large and growing market with attractive dynamics and direct specialty sales model • Recurrent and Refractory Liver Ascites - $2 billion market with 9% CAGR driven by MASH/NASH & alcoholic liver disease • Potential to Transform Underserv
Slide 46: sequanamedical
sequanamedical
Slide 47: Thank You
Thank You IR@sequanamedical.com T: +32 (0)9 496 17 27 47