Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (September 2022)
46 slides from Sequana Medical's investor presentation, September 2022
Slide 1: Pioneer in the treatment of drug-resistant fluid overload
Pioneer in the treatment of drug-resistant fluid overload liver disease, heart failure & cancer Investor presentation – September 2022 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: Uniquely positioned in two large markets
Uniquely positioned in two large markets • Proprietary technologies treating diuretic-resistant fluid overload • Key clinical problem in liver disease, heart failure, renal failure and cancer • Diuretic-resistance is common – alternatives have significant disadvantages • Strong granted IP portfolio
Slide 4: Strong Outlook for Value Drivers
Strong Outlook for Value Drivers North American Study – POSEIDON Liver disease / Q1 22: H2 23: NASH Q4 22: completion primary endpoint FDA submission alfapump® implants readout for US approval H1 H2 H1 H2 2022 2022 2023 2023 Q2 22: Heart failure Q4 22: H1 23: H2 23: all patients recruited top-line
Slide 5: alfapump
alfapump® Proven step change in the treatment of liver refractory ascites
Slide 6: alfapump
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 Rem
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 Cost
Slide 10: alfapump strong clinical and economic rationale
alfapump strong clinical and economic rationale Over 950 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 2
Slide 11: North American Pivotal Study (POSEIDON) underway
North American Pivotal Study (POSEIDON) underway Pivotal Cohort of 40 implanted patients; Roll-In (“training”) cohort of 29 implanted patients alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant Long-te
Slide 12: Interim POSEIDON: Positive for primary endpoints
Interim POSEIDON: Positive for primary endpoints Data from first 26 Roll-In patients clinically derisks the study 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 (prima
Slide 13: Interim POSEIDON: 70% survival at 12 months
Interim POSEIDON: 70% survival at 12 months* Compares favourably to published literature Published literature cited in AASLD practice guidelines: survival rate for refractory ascites patients of only 50% at 12 months1 *Preliminary survival rate analysis of Roll-In Cohort (25 March 2022) 13 13 Source
Slide 14: North American alfapump approval on track for 2024
North American alfapump approval on track for 2024 2022 2023 2024 POSEIDON Completion Primary Secondary alfapump endpoint endpoint implants readout readout PMA submission US Launch US Commercial Scale-Up Head of Clinical Sales N. America specialists Reps NTAP for breakthrough devices de-risks reim
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 ~50 initially - 35 sales reps - 10 clinical specialists - 5 corporate 15 15
Slide 16: DSR
DSR® A disease-modifying heart failure drug therapy
Slide 17: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Congestion (AKA Fluid Overload) is the primary driver of morbidity and hospitalization in heart failure patients US hospitalizations HF – annually due to ~1m 90% hospitalizations HF(3) due to fluid overload(3) c.5d Typical Annual costs of US hospital st
Slide 18: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Eliminating fluid spread across the body – working in partnership with the kidneys 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 removed from the to restore s
Slide 19: RED DESERT: Successful Proof-of-Concept Study
RED DESERT: Successful Proof-of-Concept Study 8 euvolemic HF 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 in cardio-r
Slide 20: SAHARA I (Interim): DSR Tackles Congestion
SAHARA I (Interim): DSR Tackles Congestion 10 evaluable decompensated diuretic-resistant HF patients on intensive DSR therapy1 Safely, effectively and rapidly eliminate persistent congestion & restore euvolemia • Weight loss* of ~6kg vs. baseline • No clinically relevant hyponatremia Considerably be
Slide 21: Long-Term & Major Reduction in Loop Diuretic Dosing
Long-Term & Major Reduction in Loop Diuretic Dosing Clear demonstration of improvement in cardio-renal health – driving improved clinical outcomes 600 ~23 months follow-up mg furosemide equivalents 500 RED DESERT 400 101-001 101-002 300 101-003 200 101-005 101-006 100 101-007 0 101-008† 800 ~11 mont
Slide 22: Strong Reduction in Predicted Mortality
Strong Reduction in Predicted Mortality Over 75% reduction in predicted one-year mortality based on Seattle Heart Failure Model* • Seattle Heart Failure Model is a highly validated model to predict survival in heart failure • Validated in approx. 10,000 heart failure patients in over 46 countries wi
Slide 23: Moving to Proprietary DSR 2.0
Moving to Proprietary DSR 2.0 Improved clinical and safety profile driving high margin recurring revenue stream DSR 1.0 DSR 2.0 Sodium-free D10% (off-the-shelf) Sodium-free dextrose / icodextrin (proprietary) Clinical proof-of-concept Improved therapeutic profile Rapid clinical path Favorabl
Slide 24: MOJAVE as Package for DSR Partnering
MOJAVE as Package for DSR Partnering Leveraging the strengths of established HF player to realise commercial potential of DSR 2021 2022 2023 DSR 1.0 - Phase 2a DSR study SAHARA I - Proprietary DSR 2.0 product development CMC DSR 2.0 - GLP animal studies* (safety) - SAHARA extension* US IND - Phase 1
Slide 25: Multi-Billion Market Opportunity
Multi-Billion Market Opportunity Delivering value through reduced hospitalization and improved survival • ~400K HF patients hospitalized per year in the US and EU (“frequent flyers”) • High cost patients with major burden on healthcare systems, payors and patients • Value based pricing of DSR drug d
Slide 26: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 27: Strong Outlook for Value Drivers
Strong Outlook for Value Drivers North American Study – POSEIDON Liver disease / Q1 22: H2 23: NASH Q4 22: completion primary endpoint FDA submission alfapump® implants readout for US approval H1 H2 H1 H2 2022 2022 2023 2023 Q2 22: Heart failure Q4 22: H1 23: H2 23: all patients recruited top-line
Slide 28: Strongly positioned for growth in both our markets
Strongly positioned for growth in both our markets • alfapump in liver disease / NASH – over €3 Bn / year (1) • NASH is changing liver cirrhosis market and driving growth • FDA breakthrough device status / Strong IP portfolio • North American pivotal study de-risked – Fully implanted / Positive inte
Slide 29: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Slide 30: Back-up
sequanamedical
Slide 31: 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 31 31
Slide 32: 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 33: Shareholders base and financial overview
Shareholders base and financial overview Ticker: SEQUA – Euronext Brussels • Outstanding shares: 23.7M • Outstanding shares corresponding to outstanding share options & : 2.7M • Analysts: • KBC Securities – Jeroen Van den Bossche • Kempen – Suzanne van Voorthuizen • H.C. Wainwright – Yi Chen, Raghur
Slide 34: 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 35: 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 36: Roll-In Cohort: Substantial and durable reduction in Therapeutic Paracentesis
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 37: 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 38: Roll-In Cohort: Clinically important improvement in quality of life
Roll-In Cohort: Clinically important improvement in quality of life maintained up to 12 months Physical Component Score Higher is better SF-36 General health- survey questionnaire Total Score Ascites Q Specific health- survey questionnaire for ascites Lower is better 38 38 * Clinically important imp
Slide 39: 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 40: 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 41: 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 42: 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 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: Ph. 2a in target patient population
SAHARA: Ph. 2a in target patient population 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 DSR therap
Slide 45: 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 46: 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
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