Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (January 2022)
50 slides from Sequana Medical's investor presentation, January 2022
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Investor presentation – January 2022 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: Treating diuretic-resistant fluid overload
Treating diuretic-resistant fluid overload Multi billion € markets with clear unmet clinical needs • Fluid overload is a key clinical problem in liver failure, heart failure, renal failure and cancer • Diuretics are standard of care – we are NOT replacing these • Diuretic-resistance is common – and
Slide 4: alfapump platform
alfapump® platform 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-cl
Slide 5: 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 6: Focus on two products – € billion opportunities
Focus on two products – € billion opportunities alfapump® alfapump DSR® Liver Disease (NASH) in N. America Congestion due to Heart Failure > €3 Bn / year market opportunity in US(1) > €5 Bn / year market opportunity in EU & US(2) Breakthrough Device Designation POSEIDON pivotal study enrolment compl
Slide 7: NASH drives US market attractiveness
NASH drives US market attractiveness Liver cirrhosis is transitioning to a mainstream disease requiring modern treatment options alfapump® market potential ~€0.4 Bn / year >€3 Bn / year Underlying disease Alcoholic Liver Disease, Hepatitis NASH Patient characteristic “Outside mainstream” “Mainstream
Slide 8: alfapump
alfapump ® Proven step change in the treatment of liver refractory ascites and malignant ascites
Slide 9: 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 10: Malignant ascites
Malignant ascites Severe complication of late-stage cancers Fluid accumulation in the abdomen due to drainage of lymph system Malignant ascites due to Breast and ovarian cancer have longest survival with ascites(1) breast and ovarian cancer(2): EU5: ~18K Severe impact on quality of life US: ~16K Red
Slide 11: 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 12: alfapump for long-term treatment
alfapump® for long-term treatment Over 900 implants and hundreds of years of patient experience Breakthrough Device Designation 12 12
Slide 13: Strong clinical and economic rationale
Strong clinical and economic rationale • 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 LVP / month ~$10K / implantation 15 months * Management estimate of US
Slide 14: 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 15: 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 16: Pursuing North American alfapump approval
Pursuing North American alfapump® approval 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 population
Slide 17: US commercialisation through our specialty salesforce
US commercialisation through our specialty salesforce NY MI (7) (4) PA (12) OH Initial focus on key IL (6) (6) CA transplant centres (12) NC (3) ~50-person team: AZ (5) 35 sales reps, 10 clinical, GA (3) 5 corporate TX (13) FL (8) POSEIDON site Target State (# transplant centres) 17 17
Slide 18: alfapump DSR
alfapump DSR ® Breakthrough approach to persistent congestion in heart failure built on proven alfapump® platform
Slide 19: Diuretic-resistant congestion in heart failure
Diuretic-resistant congestion in heart failure Clear unmet clinical need and driver of costs for heart failure patients 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-related $13bn hospitalisations(
Slide 20: alfapump DSR leveraging proven alfapump platform
alfapump DSR® leveraging proven alfapump® platform Fully implanted system for long-term DSR® therapy 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 DSR infusate into the bladder 3 Body el
Slide 21: RED DESERT: repeated dose alfapump DSR study
RED DESERT: repeated dose alfapump DSR® 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 22: SAHARA DESERT: Targeting persistent congestion
SAHARA DESERT: Targeting persistent congestion 20 decompensated heart failure patients with persistent congestion on high dose diuretics – ongoing Patient Start DSR® Euvolemic End DSR enrolment therapy state therapy Phase 1: Phase 2: Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive DSR therapy
Slide 23: Interim SAHARA DESERT: Indication of strong safety & efficacy results
Interim1 SAHARA DESERT: Indication of strong safety & efficacy results Safe, effective and rapid elimination of persistent congestion and restoration of euvolemia without any loop diuretics • Mean weight loss of ~6kg (=7% of body weight) vs. baseline Considerable benefit in cardio-renal status • Red
Slide 24: Persistent congestion and Worsening renal function
Persistent congestion and Worsening renal function Key drivers of mortality in decompensated heart failure Wattad et al, American Journal of Cardiology, 2015: interaction between worsening renal function and persistent congestion in acute decompensated heart failure (study of 762 patients) WRF: Wors
Slide 25: Proprietary DSR Infusate 2.0 drives value model
Proprietary DSR® Infusate 2.0 drives value model • D10% used as initial DSR infusate for fastest proof-of-concept • We are developing our proprietary next-generation DSR infusate Improved therapeutic profile IP protection Recurring revenue from high gross margin consumable 25 25
Slide 26: Short-term DSR – Derisking & extending franchise
Short-term DSR® – Derisking & extending franchise Simplifying regulatory path and preparing market for alfapump DSR® market entry Short-term DSR – “drug only” Long-term alfapump DSR – “drug / device” • “one off” ~2 weeks intensive DSR treatment • Intermittent, recurring, intensive DSR treatment • Wi
Slide 27: DSR – Robust development program
DSR® – Robust development program* Step-by-step approach to introduction of breakthrough therapy 2021 2022 2023 2024 - alfapump DSR® feasibility study SAHARA D10% infusate; decompensated heart failure patients - Proprietary DSR infusate 2.0 manufacturing DSR Infusate 2.0 - GLP animal study (chronic
Slide 28: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 29: 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 29 29
Slide 30: Strong outlook for value drivers
Liver disease / Strong outlook for value drivers 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: H1 22: H2 22: H2 22: Mid 23: H2 23: SAHAR
Slide 31: Back-up
sequanamedical
Slide 32: 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 32
Slide 33: 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 34: Shareholders base and financial overview
Shareholders base and financial overview Ticker: SEQUA – Euronext Brussels • Outstanding shares: 18.5M • Outstanding share options & warrants: 1.8M • Analysts: • KBC Securities – Jeroen Van den Bossche • Kempen – Ingrid Gafanhão • Kepler Cheuvreux – Matthias Maenhaut • Mirabaud – Daniel Jelovcan • H
Slide 35: 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 36: 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 37: 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 38: 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 39: 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 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 40: 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 41: 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 42: 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 43: 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 44: 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 45: 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 46: 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 47: 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 48: SAHARA DESERT interim analysis
SAHARA DESERT interim analysis Enrolment status – 7 December 2021 • Overall, 9 patients have been enrolled and implanted with alfapump DSR® across 2 sites • 6 patients were evaluated for interim analysis • 2 further patients just started study treatment* • 1 further patient was enrolled but died due
Slide 49: 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
Slide 50: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
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