Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (April 2022)
47 slides from Sequana Medical's investor presentation, April 2022
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Investor presentation – April 2022 Euronext: SEQUA.BR Innovators in the treatment of diuretic-resistant fluid overload
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: Uniquely positioned in two large markets
Uniquely positioned in two large markets • alfapump® in liver disease – over €3 Bn / year (1) • NASH is changing liver cirrhosis market and driving growth • Approved in EU / FDA breakthrough designation in US • US pivotal study fully enrolled / positive interim data / primary endpoint Q4 ‘22 • Direc
Slide 4: Strong outlook for value drivers
Strong outlook for value drivers North American Pivotal Study Liver disease / Q4 21: Q1 22: Q4 22: Mid 23: NASH POSEIDON POSEIDON POSEIDON FDA submission all patients recruited completion alfapump® implants primary endpoint readout for US approval 2021 2022 2023 Heart failure Q4 21: SAHARA H1 22
Slide 5: alfapump
alfapump ® Proven step change in the treatment of liver refractory ascites
Slide 6: alfapump: eliminating fluid from the peritoneal cavity
alfapump® 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-clogging Re
Slide 7: 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 8: NASH transforming the face of liver cirrhosis
NASH transforming the face of liver cirrhosis In US, liver cirrhosis is transitioning to a mainstream disease requiring modern treatment options alfapump® market potential > €3 Bn / year Underlying disease NASH Patient characteristic “Mainstream” 8 8 Notes: forecast US Liver market: Management estim
Slide 9: 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 10: alfapump strong clinical and economic rationale
alfapump® strong clinical and economic rationale Over 900 implants and hundreds of years of patient experience • Reduced burden of disease • Improved patient QoL • Cost savings for hospitals and payers Estimated treatment cost / patient*: LVP: ~$54K alfapump®: ~$35K ~$1.8K / LVP(1) ~$25K / alfapump
Slide 11: North American Pivotal Study (POSEIDON) underway
North American Pivotal Study (POSEIDON) underway Pivotal Cohort of up to 50 implanted patients; Roll-In (“training”) cohort of up to 40 patients alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months 18 months Pre-implant Post-implant Post-implant Post-implan
Slide 12: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from 26 Roll-In patients EFFICACY Over 90% reduction in mean Therapeutic Paracentesis (TP) frequency (primary endpoint >50% reduction) 100% patients with > 50% reduction in mean TP frequency per month (primary endpoint >50% of patients) SAFET
Slide 13: Interim POSEIDON: 70% survival at 12 months
Interim POSEIDON: 70% survival at 12 months Preliminary survival rate analysis of Roll-In Cohort (25 March 2022) Mean survival probability of 70% at 12 months compares favourably to published literature reporting a survival rate for refractory ascites patients of only 50% at 12 months1 13 13 Source
Slide 14: North American alfapump approval on track for 2024
North American alfapump® approval on track for 2024 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
Slide 15: US – Go direct to liver transplant centres
US – Go direct to 140 liver transplant centres Highly efficient approach to target doctors and patients – driven by treatment guidelines 140 liver transplant centres ~50 person team initially - 35 sales reps - 10 clinical specialists - 5 corporate 15 15
Slide 16: DSR
DSR ® Breakthrough approach to persistent congestion in heart failure
Slide 17: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Removal of congestion is a key therapeutic target and maintaining renal function is clinical challenge 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-r
Slide 18: 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 19: alfapump DSR leveraging proven alfapump platform
alfapump DSR® leveraging proven alfapump® platform Fully implanted system for long-term DSR® therapy – keeping patients out of the hospital 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
Slide 20: RED DESERT: Successful Proof-of-Concept Study
RED DESERT: Successful Proof-of-Concept Study 8 euvolemic heart failure patients on high dose diuretics treated with DSR 3x per week up to 6 weeks Highly effective management of fluid and sodium balance • Generally safe and well tolerated; no clinically relevant hyponatremia Significant improvement
Slide 21: SAHARA DESERT: Ph. 2a positive interim data
SAHARA DESERT: Ph. 2a positive interim data Data from 6 patients indicates additional ability to safely decongest decompensated patients Safe, effective and rapid elimination of persistent congestion and restoration of euvolemia without any loop diuretics • Mean weight loss of ~6kg (=7% of body weig
Slide 22: Persistent congestion and Worsening renal function
Persistent congestion and Worsening renal function Persistent congestion and worsening renal function are key targets in decompensated heart failure Wattad et al, American Journal of Cardiology, 2015: interaction between worsening renal function and persistent congestion in acute decompensated heart
Slide 23: Proprietary heart failure drug development programme
Proprietary heart failure drug development programme Red Desert Sahara Desert 2nd Gen. Infusate Mojave Desert Sonoran Desert PoC Ph. 2a ongoing Development Ph. 1b/2a (US) Ph. 2a (US) • 1st Gen. Infusate + • 1st Gen. Infusate + • Animal GLP • 2nd Gen. Infusate • 2nd Gen. Infusate alfapump alfapump
Slide 24: DSR – plan to partner after US efficacy study
DSR® – plan to partner after US efficacy study Step-by-step approach to introduction of breakthrough therapy in decompensated HF patients 2021 2022 2023 2024 Infusate 1st Gen. - Ph. 2a alfapump DSR® study SAHARA D10% Infusate + alfapump® - Proprietary DSR Infusate 2.0 manufacturing Infusate 2.0 2nd
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
Strong outlook for value drivers North American Pivotal Study Liver disease / Q4 21: Q1 22: Q4 22: Mid 23: NASH POSEIDON POSEIDON POSEIDON FDA submission all patients recruited completion alfapump® implants primary endpoint readout for US approval 2021 2022 2023 Heart failure Q4 21: SAHARA H1 22
Slide 28: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Slide 29: Back-up
Back-up 29
Slide 30: Sequana Medical NV
Sequana Medical NV Founded in 2006 Gent, Belgium (HQ): corporate, clinical, commercial Zurich, Switzerland: manufacturing, engineering, QA/RA ~60 employees Euronext Brussels: SEQUA 30
Slide 31: Strong organisation
Strong organisation Highly experienced leadership team supported by committed and well-reputed shareholders Executive team: Ian Crosbie Kirsten Van Bockstaele Oliver Gödje Dragomir Lakic Chief Executive Officer Chief Financial Officer Chief Medical Officer VP Manufacturing Gijs Klarenbeek Martijn Bl
Slide 32: Shareholders base and financial overview
Shareholders base and financial overview Ticker: SEQUA – Euronext Brussels • Outstanding shares: 23.7M • Outstanding share options & warrants: 2.7M • Analysts: • KBC Securities – Jeroen Van den Bossche • Kempen – Christophe Beghin • Kepler Cheuvreux – Matthias Maenhaut • Mirabaud – Daniel Jelovcan •
Slide 33: POSEIDON – study cohorts
POSEIDON – study cohorts Patients with recurrent or refractory ascites due to liver cirrhosis in up to 20 centres across US and Canada Two study cohorts with the same inclusion / exclusion criteria •1 Pivotal Cohort • Up to 50 patients implanted with the alfapump® • For primary and secondary endpoin
Slide 34: Recurrent or refractory ascites – patient profile
Recurrent or refractory ascites – patient profile 26 patients from the Roll-In Cohort in the POSEIDON study N. American patients are Age (mean) 63 y treated early in MELD score (mean ± SD) 10.3 ± 3.9 their disease Cirrhosis etiology - Alcohol - 50.0% NASH is - NASH - 23.1% becoming a major - NASH /
Slide 35: Roll-In Cohort: Substantial and durable reduction in TP
Roll-In Cohort: Substantial and durable reduction in Therapeutic Paracentesis (TP) Primary efficacy endpoint Interim data Mean values Pivotal Cohort Roll-In Cohort (N = 26) % reduction in monthly frequency of TP > 50% (1) > 90% (2) % patients with >50% reduction in TP > 50% (1) 100% (2) (1) Monthly
Slide 36: Roll-In Cohort: Safety in line with expectations
Roll-In Cohort: Safety in line with expectations Primary safety endpoint: • Rate of alfapump related re-interventions adjudicated by Clinical Events Committee (CEC) Interim data Roll-In Cohort (N=26): • No unanticipated adverse device effects • Three patients experienced a composite primary safety e
Slide 37: Roll-In Cohort: Quality of life improvement maintained up to 12 months
Roll-In Cohort: Clinically important improvement in quality of life maintained up to 12 months Physical Component Score 5 point increase = clinically important improvement* Higher is better SF-36 General health- survey questionnaire Total Score 20 point decrease = clinically important improvement* A
Slide 38: Leading experts as Heart Failure Scientific Advisors
Leading experts as Heart Failure Scientific Advisors Dr. Maria Rosa Costanzo Dr. Wilson Tang Medical Director of the Edward Center for Professor of Medicine at Cleveland Clinic Lerner Advanced Heart Failure College of Medicine at Case Western Reserve Medical Director Heart Failure Research for the U
Slide 39: RED DESERT – The first repeated DSR therapy study
RED DESERT – The first repeated DSR® therapy study Repeated dose proof-of-concept study of alfapump DSR® in stable heart failure patients on high dose diuretics alfapump® + surgical start DSR therapy discharged from end DSR port implantation in hospital hospital therapy 2 weeks 2 weeks 4 weeks DSR t
Slide 40: RED DESERT: Highly effective management of fluid & sodium
RED DESERT: Highly effective management of fluid & sodium No loop diuretics required during study despite mean baseline dose of >300 mg/day furosemide equivalents Ejection Fraction (%) NT-proBNP (pg/mL) Daily Dose of loop diuretics (mg)** During DSR Treatment Subject At baseline At baseline At basel
Slide 41: RED DESERT: Dramatic improvement in diuretic efficiency
RED DESERT: Dramatic improvement in diuretic efficiency Over 150% increase in mean diuretic response* Diuretic efficiency 8 p<.001 6h Na excretion (gr) 6 4 2 0 Baseline End * 6 hour Na excretion following administration of 40mg intravenous furosemide; paired statistical analysis of patients with bas
Slide 42: RED DESERT: Long-term follow-up of patients
RED DESERT: Long-term follow-up of patients Durable improvement in diuretic response following alfapump DSR® therapy Daily dose of loop diuretics** During DSR Time since last Currrent known treatment DSR treatment in the Current known reduction in Subject At screening (D0 – D42) study daily dose***
Slide 43: RED DESERT: Significant improvement in cardio-renal function
RED DESERT: Significant improvement in cardio-renal function* NT-proBNP Creatinine p<.001 6000 p<.001 1.5 4000 1.0 mg/dL pg/mL 2000 0.5 0 0.0 Baseline End Baseline End 30% decrease 22% increase 22% decrease in mean natriuretic peptides in mean eGFR in mean creatinine “The simultaneous normalisation
Slide 44: SAHARA DESERT: Ph. 2a in target patient population
SAHARA DESERT: Ph. 2a in target patient population 20 decompensated heart failure patients with persistent congestion on high dose diuretics – ongoing Patient Start 1st Gen Euvolemic End DSR enrolment DSR® therapy state therapy Phase 1: Phase 2: Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive
Slide 45: SAHARA DESERT interim analysis
SAHARA DESERT interim analysis 6 severe heart failure patients with persistent congestion on high dose diuretics Mean values at baseline of 6 patients in interim analysis Left ventricular ejection fraction: low 20% NT-proBNP: >6,000 pg/mL Furosemide equivalent dose: ~250 mg/day (standard of care) NT
Slide 46: SAHARA DESERT interim analysis
SAHARA DESERT interim analysis Repeated alfapump® DSR therapy was safe and well-tolerated • No clinically significant changes in serum sodium levels or other electrolytes after intensive DSR therapy • Reported adverse events were manageable: Diarrhea (1 patient) Catheter blockage (1 patient) S
Slide 47: Evaluating potential for DSR in renal failure
Evaluating potential for DSR® in renal failure Complementary opportunity leveraging heart failure programme capabilities • Like heart failure, kidney failure / dialysis is one of the leading burdens for healthcare systems and carries a high mortality / morbidity burden • Hemodialysis seeks to tackle