Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Kepler Cheuvreux Belgian Life Science Day 2020
18 slides from Sequana Medical's conference presentation, Jun 22, 2020
Slide 1: Innovators in the management of fluid overload
Innovators in the management of fluid overload liver disease – malignant ascites – heart failure Kepler Cheuvreux Belgian Life Science Day 22 June 2020 Ian Crosbie, CEO
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: COVID-19 notice
COVID-19 notice Sequana Medical is closely following the evolution of the COVID-19 global health crisis and is in constant dialogue with its partners to assess the impact and adapt its operations as necessary. Although it is difficult to draw conclusions at this point on the systemic risk this disea
Slide 4: alfapump platform
alfapump® platform Using the bladder to manage 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 5: One platform – two products
One platform – two products alfapump® alfapump® DSR Liver Disease (NASH) Heart Failure Breakthrough approach to fluid overload in Proven step change in liver refractory ascites heart failure and malignant ascites Clinical proof-of-concept of Over 750 devices implanted Direct Sodium Removal (DSR) ~14
Slide 6: 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 7: Refractory ascites – a key complication of liver cirrhosis
Refractory ascites – a key complication of liver cirrhosis with a dramatic impact on quality of life US forecast ~3-4M (1) Liver cirrhosis “Normal Life” ~5 days ~1.5M (2) High mortality rate Decreased mobility & Ascites appetite, Drainage Extreme discomfort nausea and ~2 days constipation ~5 days ~1
Slide 8: North American Pivotal Study (POSEIDON) underway
North American Pivotal Study (POSEIDON) underway • Up to 50 patients with recurrent or refractory ascites due to liver cirrhosis implanted with the alfapump(1) • Primary endpoint at 9 months after enrollment: proportion of patients with a 50% reduction in average number of paracentesis per month p
Slide 9: alfapump US approval roadmap
alfapump® US approval roadmap Key anticipated milestones* 2019 2020 2021 2022 2023 POSEIDON: FDA IDE First Last Interim Primary Final results* approval patient in patient in* analysis* Endpoint (2° outcomes) Reporting* FDA breakthrough Filing* Approval*, designation Building out followed by US
Slide 10: Self-commercialisation in US through specialty salesforce
Self-commercialisation in US through 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) 10 10
Slide 11: Volume overload in heart failure – major clinical problem
Volume overload in heart failure – major clinical problem and key driver of costs US hospitalisations HF – annually due to ~1m 90% hospitalisations HF(3) due to volume overload(3) Excess sodium drives c.5d Typical fluid overload Annual costs of US hospital stay(4) HF-related $13bn hospitalisations(4
Slide 12: Direct sodium removal (DSR)
Direct sodium removal (DSR) Remove the sodium and the body will eliminate the excess fluid Too much sodium Removing the sodium Elimination of excess drives fluid overload (DSR) fluid alfapump® Remove Administer Administer Infusate Infusate removes extracted Body restores Body restores infusateto inf
Slide 13: DSR pre-clinical and clinical Proof-of-Concept
DSR pre-clinical and clinical Proof-of-Concept Pre-clinical studies1 First-in-human study2 (N=10) 18 N=5 16 14 Sodium (g)* 12 * 10 8 N = 10 6 4 2 0 healthy pigs HF pigs with with DSR DSR 1: administration of 1 litre DSR infusate, with 2 hour dwell 2: Cross-over study: administration of 1 litre DSR i
Slide 14: alfapump DSR
alfapump® DSR Fully implanted and convenient system for DSR therapy leveraging proven elements DSR 1 alfapump Implanted Port 3 Implanted port 2 4 Potential chronic therapy for heart failure patients that are not well controlled on diuretics 14 14
Slide 15: RED DESERT – First-In-Human Repeated Dose alfapump DSR study ongoing
RED DESERT – First-In-Human Repeated Dose alfapump® DSR study ongoing • Up to 10 patients with heart failure on high dose diuretics across 2 centres (Belgium and Georgia) • Patients put on a low sodium diet without diuretics and implanted with alfapump DSR system • Evaluation of safety and feasibili
Slide 16: alfapump DSR development overview
alfapump® DSR development overview Study description 2018 2019 2020 2021 2022 2023 Clinical proof-of-concept DSR therapy First in human DSR study: single dose, no alfapump Clinical proof-of-concept alfapump DSR* ONGOING First in human alfapump DSR study*: repeated dose, with alfapump (RED DESERT
Slide 17: Expected core value drivers
Expected core value drivers* alfapump® alfapump® DSR Liver Disease (NASH) Heart Failure • Completion patient enrolment in POSEIDON study (H2 2020) • Initial results of RED DESERT study (H2 2020) • Interim results of POSEIDON study (H1 2021) • Presentation of results of RED DESERT study (H1 2021) * T
Slide 18: Thank You
Thank You IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Sequana Medical — Kepler Cheuvreux Belgian Life Science Day 2020 on 6ix