Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H1 2021 Earnings Presentation
16 slides from Sequana Medical's earnings presentation, Sep 2, 2021
Slide 1: H1 2021 Financial Results & Business Update
H1 2021 Financial Results & Business Update 2 September 2021
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: 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 5: YTD 2021 Highlights
YTD 2021 Highlights alfapump® – results from 2nd interim analysis of POSEIDON in recurrent / refractory liver ascites re-confirm positive outcomes against all primary endpoints; awaiting FDA approval on POSEIDON pivotal study expansion alfapump® – FDA regulatory submission now expected in mid-20
Slide 6: Building Sequana Medical on two platforms
Building Sequana Medical on two platforms Complementary approaches to diuretic-resistant fluid overload alfapump® alfapump DSR® DSR® Congestive Heart Liver Disease / Failure NASH & Malignant Ascites Long-term Short-term therapy therapy Evaluating Renal Failure Fluid Overload 6 6
Slide 7: 2nd interim POSEIDON: Positive for primary endpoints
2nd interim POSEIDON: Positive for primary endpoints Data from 26 Roll-In patients with recurrent or refractory liver ascites implanted with the alfapump® Substantial and durable reduction in need for Therapeutic Paracentesis (TP) • Over 90% reduction in mean frequency of TP post- vs. pre-implant1
Slide 8: Key Takeaways from KOL webinar with Dr. Vargas and Dr. Knuttinen
Key Takeaways from KOL webinar with Dr. Vargas and Dr. Knuttinen from Mayo Clinic, Arizona High Burden • Ascites has a significant negative impact on patients and may lead to serious complications Increasing • Net effect of NASH becoming very prevalent is that we will see an increased incidence of p
Slide 9: N. American Liver Programme Update
N. American Liver Programme Update • POSEIDON – Submitted protocol amendment to the US FDA to extend patient enrolment due to the higher attrition rate prior to implantation • Discussions with the FDA ongoing • Update on timelines for completion of patient enrolment and subsequent primary endpoint r
Slide 10: Resumed commercial activity in Europe in H2 2021
Resumed commercial activity in Europe in H2 2021 H1 2021 • Reduced supply of alfapump systems to European commercial markets • Resolved low manufacturing yield of alfapump systems H2 2021 • Resumed commercial activities in Germany and France in August • 2021 revenues expected, on a pro rata basis, i
Slide 11: RED DESERT: Strong clinical proof-of-concept
RED DESERT: Strong clinical proof-of-concept Data from 8 euvolemic heart failure patients on high-dose diuretics treated with DSR 3x per week up to 6 weeks Highly effective replacement of high-dose loop diuretics Generally safe and well tolerated; no clinically relevant hyponatremia Dramatic a
Slide 12: Heart Failure – Continued progress in SAHARA DESERT and DSR development programme
Heart Failure – Continued progress in SAHARA DESERT and DSR® development programme • First patients enrolled in SAHARA DESERT • Plan for 20 decompensated heart failure patients with persistent congestion despite high doses of diuretics • Evaluate ability of alfapump DSR® to eliminate persistent cong
Slide 13: Key Financial Results H1 2021
Key Financial Results H1 2021 Revenue: €23K • Reduced supply of alfapump to European commercial markets • Impact of COVID-19 on alfapump procedures in Germany and France Operating expenses: - €11,501K • Preparations for submissions for marketing approval in US and Canada • DSR pre-clinical and clini
Slide 14: Highly experienced leadership team
Highly experienced leadership team Appointment of Jackie Fielding, replacing Jason Hanon as Non-Executive Director Executive team: Ian Crosbie Kirsten Van Bockstaele Oliver Gödje Dragomir Lakic Chief Executive Officer Chief Financial Officer Chief Medical Officer VP Manufacturing Gijs Klarenbeek Mar
Slide 15: Expected core value drivers & outlook
NASH in North Expected core value drivers & outlook Liver disease / Q2 21: America TBD*: TBD*: POSEIDON POSEIDON POSEIDON interim analysis LPI primary endpoint 2021 2022 Heart failure in North America Q2RED 21: Q2 21: & Europe Q4 21: H2 22: H2 22: SAHARA SAHARA SAHARA MOJAVE DESERT DESERT DESERT
Slide 16: Q&A
Q&A