Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H1 2023 Earnings Presentation
15 slides from Sequana Medical's earnings presentation, Sep 14, 2023
Slide 1: HY 2023 Financial Results & Business Update
HY 2023 Financial Results & Business Update Webcast presentation – 14 September 2023
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: Strong progress in both programs
Strong progress in both programs alfapump advancing towards US and Canadian launch and Phase 1/2a US MOJAVE DSR study underway alfapump® – US approval in liver disease expected in 2024 Additional POSEIDON data reported, reaffirming strong clinical profile of alfapump Data from POSEIDON presented
Slide 5: POSEIDON – strong clinical profile of alfapump
POSEIDON – strong clinical profile of alfapump Primary and key secondary endpoints presented by Prof. Wong, PI, at leading international liver congress Effective in control of ascites, “virtually eliminating needle paracentesis” NASH is already a key driver of decompensated cirrhosis Safety in li
Slide 6: Attractive pricing with derisked reimbursement
Attractive pricing with derisked reimbursement Existing DRG payment and breakthrough device designation de-risk reimbursement of alfapump Coding – Strong existing position with potential for further upside • Existing US hospital DRG payment for alfapump procedure of $60-70K in target hospitals* • Su
Slide 7: US – Go direct to liver transplant centers
US – Go direct to 90 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines 125 adult centres, of which 90 cover 95% of transplants ~50 commercial team initially Source: Organ Procurement & Transplantation Network, US Dept of HHS (optn.tran
Slide 8: DSR 2.0 improves therapeutic and safety profile
DSR 2.0 improves therapeutic and safety profile Strong granted IP drives high margin recurring revenue stream Additional DSR patents granted in the US and China • Expansion of composition of matter and method patent in the US, including oncotic and osmotic agents and the use of an implantable pump
Slide 9: MOJAVE – Phase 1/2a randomized controlled US study
MOJAVE – Phase 1/2a randomized controlled US study Seeking to replicate SAHARA outcomes in US study of heart failure patients with persistent congestion 4 weeks 3 months DSR therapy (up to daily) + optimized usual care vs. Safety follow-up period IV loop diuretic + optimized usual care Endpoints • S
Slide 10: MOJAVE – initial data expected in Q4 2023
MOJAVE – initial data expected in Q4 2023 First patients enrolled in non-randomized cohort 2023 2024 2025 Non-randomized cohort Randomized cohort (N=3) (N=30, DSR = 20, control = 10) INDbyclearance FDA DSMB approval Initial Interim Top-line data* data data Top-line data in mid 2025 intended to del
Slide 11: Key financial results H1 2023
Key financial results H1 2023 Equity placement of €15.8 M in April 2023 extended cash runway into Q1 2024 Revenue: €384 K • Commercial activities in Europe scaled back Operating expenses: - €15.9 M • Preparation of submissions for marketing approval of alfapump in US and Canada • IND filing for DSR
Slide 12: Kenneth Macleod appointed to our Board of Directors
Kenneth Macleod appointed to our Board of Directors • Partner at Rosetta Capital • Over 35 years in life sciences sector • Healthcare companies: Abbott Laboratories, Serono SA • Life science fund management: SV Health Investors, Paul Capital Partners, Visium Healthcare Partners • Board member of Jen
Slide 13: Strong outlook for key value drivers
Strong outlook for key value drivers North American alfapump study – POSEIDON Liver disease / Q2 ‘23: H2 ‘23: Q4 ‘23: H2 ‘24: NASH Additional data Patient preference PMA submission Anticipated FDA at EASL & Matched registry* to FDA approval data 2023 2024 Q2 ‘23:Mid ‘23: Heart failure Q4 ‘23: H1‘
Slide 14: Leader in large markets with unmet needs
Leader in large markets with unmet needs Near term liver opportunity with visibility into heart failure alfapump in liver disease DSR in heart failure • Market growing to over $2.5 billion by 2035(1) • Multi-billion commercial opportunity – 400K patients in the US & EU • FDA breakthrough device / Ap
Slide 15: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com