Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — FY2021 Earnings Presentation
17 slides from Sequana Medical's earnings presentation, Apr 12, 2022
Slide 1: 2021 Full Year Results & Business Update
2021 Full Year Results & Business Update 12 April 2022 Innovators in the treatment of diuretic-resistant fluid overload
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Kirsten Van Bockstaele Chief Executive Officer Chief Financial Officer 2 2
Slide 3: 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 4: 2021 & YTD Highlights
2021 & YTD Highlights alfapump® in liver disease / NASH Positive results from second interim analysis of POSEIDON pivotal study; encouraging survival data at 12 months vs. published literature Patient enrolment and implants completed; primary endpoint on track for Q4 2022 FDA regulatory submiss
Slide 5: Year in Review: alfapump in liver disease / NASH
Year in Review: alfapump® in liver disease / NASH North America POSEIDON: POSEIDON: KOL event: MDSAP: POSEIDON: alfapump Completion of 2nd positive interim data Dr. Vargas and Dr. Expanding QMS in Completion of alfapump (26 Roll-In patients) Knuttinen, Mayo Clinic US and Canada patient enrolment imp
Slide 6: 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 7: 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 7 7 Source 1:
Slide 8: 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 9: 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 9 9
Slide 10: Year in Review: DSR in heart failure
Year in Review: DSR® in heart failure RED DESERT: SAHARA DESERT: SAHARA DESERT: Successful proof-of- First patient Phase 2a positive concept enrolled interim data DSR 2021 DSR 2022 IP: Proprietary DSR Infusate 2.0: Key DSR and alfapump DSR Strong progress in CMC development & patents granted in US a
Slide 11: DSR – Encouraging phase 2a heart failure data
DSR® – Encouraging phase 2a heart failure data Clearing congestion while preserving renal function is a key objective of heart failure therapy RED DESERT – Completed SAHARA DESERT – Ongoing (Interim data) (8 Euvolemic heart failure patients) (6 Decompensated heart failure patients) Clinical proof-
Slide 12: Proprietary DSR drug development
Proprietary DSR® drug development Driver of high margin recurring revenue stream leveraging extensive clinical experience 1st Generation Infusate Sodium-free D10% (off-the-shelf) Rapid clinical path: Red Desert; Sahara Desert Clinical proof of concept 2nd Generation Infusate Sodium-free dext
Slide 13: DSR – plan to partner after US efficacy study
DSR® – plan to partner after US efficacy study Step-by-step approach to introduction of breakthrough heart failure therapy 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 Gen. Infusate -
Slide 14: Key Financial Results FY 2021
Key Financial Results FY 2021 Revenue: €371K • Limited European commercial activities due to reduced supply of alfapump (up to August) and impact of COVID-19 Operating expenses: - €22.9M • Preparation of submissions for marketing approval in US and Canada • Pre-clinical and clinical development of p
Slide 15: 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 16: 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 int
Slide 17: Q&A
Q&A