Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H1 2022 Earnings Presentation
14 slides from Sequana Medical's earnings presentation, Sep 8, 2022
Slide 1: H1 2022 Financial Results & Business Update
H1 2022 Financial Results & Business Update Webcast presentation – 8 September 2022
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: 2022 YTD highlights
2022 YTD highlights Important progress in both our liver disease and heart failure programs alfapump® – towards approval in North America On track to report primary endpoint data of pivotal POSEIDON study in Q4 2022 Interim analysis(1) shows 70% survival rate at one year post implantation Euro
Slide 5: POSEIDON on track to report top-line data in Q4 2022
POSEIDON on track to report top-line data in Q4 2022 North American pivotal study of alfapump in patients with recurrent and refractory ascites due to liver cirrhosis All patients implanted with the alfapump • Roll-In Cohort: 29 implants • Pivotal Cohort: 40 implants Strong interim data reported i
Slide 6: Preparing for direct US commercialization
Preparing for direct US commercialization Highly efficient approach to target doctors and patients – driven by treatment guidelines 140 ~50 initially - 35 sales reps - 10 clinical specialists - 5 corporate 6 6
Slide 7: SAHARA reports strong interim data
SAHARA reports strong interim data Phase 2a study of DSR therapy in diuretic-resistant heart failure patients with persistent congestion Interim data show dramatic and durable improvements in validated clinical measures (1) • Safe, rapid and effective decongestion • Clear improvements in cardio-ren
Slide 8: DSR – A Disease-Modifying Heart Failure Drug Therapy
DSR – A Disease-Modifying Heart Failure Drug Therapy RED DESERT and SAHARA I deliver clinical proof-of-concept – addressing key unmet clinical needs Long-term & major reduction in loop diuretic dosing • up to 23 months in RED DESERT and up to 11 months in SAHARA I No heart failure congestion-relat
Slide 9: Moving to Proprietary DSR 2.0
Moving to Proprietary DSR 2.0 Improved clinical and safety profile driving high margin recurring revenue stream DSR 1.0 DSR 2.0 Sodium-free D10% (off-the-shelf) Sodium-free dextrose / icodextrin (proprietary) Clinical proof-of-concept Improved therapeutic profile Rapid clinical path Favorabl
Slide 10: DSR 2.0: Planning to kick-off US Ph. 1b/2a MOJAVE in H1 2023
Planning to kick-off US Ph. 1b/2a MOJAVE in H1 2023 Randomized, controlled, multi-center study 2021 2022 2023 DSR 1.0 - Phase 2a DSR study SAHARA I - Proprietary DSR 2.0 product development CMC DSR 2.0 - GLP animal studies* (safety) - SAHARA extension* US IND - Phase 1b/2a DSR study in US* MOJAVE ~3
Slide 11: Key Financial Results H1 2022
Key Financial Results H1 2022 Revenue: €464K • Resumed commercial activity in Europe as the impact of COVID declines Operating expenses: - €13.6M • Preparation of submissions for marketing approval in US and Canada • Pre-clinical and clinical development of proprietary DSR therapy Net result: - €14.
Slide 12: Two highly experienced medtech leaders appointed to our Board of Directors
Two highly experienced medtech leaders from the US appointed to our Board of Directors • CEO of Responsive Arthroscopy • Senior VP Global Health Economics, • >40 years in medical device industry Policy & Reimbursement at Medtronic • Founder and CEO of leading medtech • >30 years healthcare experienc
Slide 13: Strong Outlook for Value Drivers
Strong Outlook for Value Drivers North American Study – POSEIDON Liver disease / Q1 22: H2 23: NASH Q4 22: completion primary endpoint FDA submission alfapump® implants readout for US approval H1 H2 H1 H2 2022 2022 2023 2023 Q2 22: Heart failure Q4 22: H1 23: H2 23: all patients recruited top-line
Slide 14: Q&A
Q&A IR@sequanamedical.com +32 498 053579 www.sequanamedical.com