Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Needham Virtual Healthcare Conference 2021
30 slides from Sequana Medical's conference presentation, Apr 12, 2021
Slide 1: Innovators in the treatment of diuretic-resistant fluid overload
Innovators in the treatment of diuretic-resistant fluid overload liver disease – malignant ascites – heart failure Needham Virtual Healthcare Conference Ian Crosbie, CEO – 12 April 2021
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
Disclaimers Regulatory disclaimer: • The alfapump® system has not yet received regulatory approval in the United States and Canada. Any statement in this presentation about safety and efficacy of the alfapump® system does not apply to the United States and Canada. In the United States and Canada, th
Slide 4: Sequana Medical NV
Sequana Medical NV Founded in 2006 Gent, Belgium (HQ): corporate, clinical, commercial Zurich, Switzerland: manufacturing, engineering, QA/RA ~50 employees Euronext Brussels: SEQUA 4
Slide 5: alfapump platform
alfapump® platform Using the bladder to treat fluid overload 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 Remote data monitoring No significant
Slide 6: One platform – two products – € billion opportunities
One platform – two products – € billion opportunities alfapump® alfapump DSR® Liver Disease (NASH) Heart Failure Proven step change in liver refractory ascites Breakthrough approach to fluid overload in and malignant ascites heart failure Over 850 devices implanted Clinical proof-of-concept of Direc
Slide 7: NASH drives US market attractiveness
NASH drives US market attractiveness Stronger competitive position in a much larger and dynamic market alfapump® market potential ~€0.4 Bn / year >€3 Bn / year Underlying disease Alcoholic Liver Disease, Hepatitis NASH Patient characteristic “Outside mainstream” “Mainstream” Average age 40-50 yr 70
Slide 8: alfapump
alfapump ® Proven step change in the management of liver refractory ascites and malignant ascites
Slide 9: Liver cirrhosis and refractory ascites
Liver cirrhosis and refractory ascites A key complication of liver cirrhosis, with a dramatic impact on quality of life US forecast ~3-4M (1) Viral infections Liver (Hepatitis B & C) “Normal Life” cirrhosis ~5 days ~1.5M Decreased (2) High mortality rate mobility & Alcoholic Liver appetite, Ascites
Slide 10: Cancer and malignant ascites
Cancer and 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 U
Slide 11: Severe limitations of existing therapies
Severe limitations of existing therapies Transjugular Intrahepatic Diet / Diuretics Portosystemic Shunt (TIPS) alfapump® Resistance, Complications, Complications Contraindications Drainage (“Large Volume Paracentesis / LVP”) Liver transplantation Painful, Poor Quality of High Cost, Life, Short Term
Slide 12: alfapump for long-term treatment
alfapump® for long-term treatment Over 850 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 patients implanted; Roll-In (“training”) cohort of up to 30 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: POSEIDON Interim Data: Positive for primary endpoints
POSEIDON Interim Data: Positive for primary endpoints Data from first 13 Roll-In patients EFFICACY Mean values post-implant vs. pre-implant N = 13 Reduction in frequency of TP > 90% Patients with >50% reduction in TP 100% SAFETY • Safety profile of the alfapump consistent with previously reported da
Slide 16: Quality of Life: Indication of fast and persistent improvement
Quality of Life: Indication of fast and persistent improvement Physical Component Score 5 point improvement = clinically relevant Higher is better SF-36 General health- survey questionnaire Total Score 20 point reduction = clinically relevant Ascites Q Specific health- survey questionnaire for ascit
Slide 17: Targeting announcement of primary endpoint in Q2 2022
Targeting announcement of primary endpoint in Q2 2022 2019 2020 2021 2022 FDA IDE First Interim Last Interim Primary approval patient in analysis 1 patient analysis 2* Endpoint in* Reporting* FDA breakthrough Filing* designation Building out US team MCIT & NTAP – final CMS rules for breakthro
Slide 18: 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) 18 18
Slide 19: alfapump DSR
alfapump DSR ® Breakthrough approach to fluid overload in heart failure built on proven alfapump® platform
Slide 20: Diuretic-resistant fluid overload in heart failure
Diuretic-resistant fluid overload in heart failure Key clinical challenge and driver of costs US hospitalisations HF – annually due to ~1m 90% hospitalisations HF(3) due to fluid overload(3) Excess sodium drives c.5d Typical fluid overload Annual costs of US hospital stay(4) HF-related $13bn hospita
Slide 21: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR®) Proprietary approach to fluid overload – supported by interim RED DESERT clinical data We remove the sodium and then the body “does the math” to maintain serum sodium balance DSR therapy directly Body eliminates removes the sodium excess fluid “DSR represents a new poten
Slide 22: alfapump DSR
alfapump DSR® Potential chronic therapy for diuretic-resistant heart failure patients with fluid overload Sodium-free DSR® infusate administered to 1 peritoneal cavity via implanted port 2 Sodium diffuses into DSR infusate 1 alfapump pumps sodium-rich DSR infusate into the 3 bladder Body eliminates
Slide 23: RED DESERT: Study design
RED DESERT: Study design Repeated dose proof-of-concept study of alfapump DSR® in diuretic-resistant heart failure patients alfapump® + surgical start DSR® therapy discharged from end DSR port implantation in hospital hospital therapy 2 weeks 2 weeks 4 weeks DSR therapy Continued DSR therapy Stabili
Slide 24: Interim RED DESERT: Strong safety & efficacy results
Interim RED DESERT: Strong safety & efficacy results Results from first five patients SAFETY • Implant procedure of alfapump DSR® and repeated dosing of DSR® therapy were well-tolerated • No clinically significant changes in serum sodium levels / no progressive hyponatremia • Reported adverse events
Slide 25: Interim RED DESERT: Restored normal kidney response
Interim RED DESERT: Restored normal kidney response Results from first five patients • Diuretic response restored to near normal levels • Sodium excretion more than doubled after DSR study period (to near normal levels) • Long-lasting improvement in diuretic responsiveness • Dramatic reduction in or
Slide 26: SAHARA DESERT: Study design
SAHARA DESERT: Study design Dose-ranging study to investigate improvement in diuretic response and durability of effect • 20 decompensated heart failure patients with residual congestion, implanted with alfapump DSR® • Group 1 (N= 10): DSR treatment plus standard dose of SGLT2-inhibitor • Group 2 (N
Slide 27: Developing high value proprietary DSR Infusate
Developing high value proprietary DSR® Infusate • D10% was chosen as the initial DSR infusate for fastest proof-of-concept • We are developing our proprietary next-generation DSR infusate: Improved therapeutic profile compared to D10% IP protected Recurring revenue from high gross margin consu
Slide 28: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 29: Expected core value drivers & outlook
Expected core value drivers & outlook NASH in North Liver disease / POSEIDON Q4 20: Q2 21: Q2 21: Q2 22: America POSEIDON POSEIDON POSEIDON 1st interim analysis LPI 2nd interim analysis primary endpoint Q4 2020 2021 H1 2022 Heart failure in North America Q4 20: & Europe Q2 21: Q2 21: Q4 21: H1 22
Slide 30: Thank You
Thank You IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
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