Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H1 2020 Earnings Presentation
17 slides from Sequana Medical's earnings presentation, Sep 3, 2020
Slide 1: H1 2020 Financial Results & Business Update
H1 2020 Financial Results & Business Update 3 September 2020
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Kirsten Van Bockstaele Chief Executive Officer Chief Financial Officer 2 2
Slide 3: Forward-Looking Statements
Forward-Looking Statements 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-a
Slide 4: Disclaimers
Disclaimers Regulatory disclaimer: • The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent asc
Slide 5: Agenda
Agenda YTD 2020 Highlights Business Update Key Financial Results H1 2020 Core Value Drivers & Outlook Q&A 5 5
Slide 6: YTD 2020 Highlights
YTD 2020 Highlights POSEIDON – implants in Canada continue, interim results expected in H1 2021 RED DESERT – implants continue, interim results expected in Q4 2020 DSR – fundamental patents allowed in US and Europe Continued growth in European commercial implants Positive data published in
Slide 7: Strategic Focus
Strategic Focus alfapump® alfapump® DSR Liver Disease (NASH) Heart Failure - POSEIDON pivotal study ongoing - RED DESERT repeated dose study ongoing - Self-commercialisation - Partnering after US feasibility study Built upon proven European clinical & commercial experience 7 7
Slide 8: POSEIDON – to support approval in US and Canada
POSEIDON – to support approval in US and Canada North American pivotal study of the alfapump® in recurrent and refractory ascites due to liver cirrhosis Proportion of patients with a 50% reduction in average number of paracentesis per month post- implant vs pre-implant • Delay due to COVID-19 restri
Slide 9: Limitations of Diuretic Therapy in Heart Failure
Limitations of Diuretic Therapy in Heart Failure High unmet need for safe and effective chronic treatment solution to treat volume overload Diuretics primarily remove Body retains water and cuts back hypotonic urine on urination to restore homeostasis 40% of heart failure patients on IV loop diure
Slide 10: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) Sequana Medical’s breakthrough approach to volume overload in heart failure DSR therapy directly Body eliminates removes the sodium excess fluid “DSR represents a new potential therapy for non-renal sodium and fluid removal in edematous disorders such as heart failure” 10
Slide 11: alfapump DSR
alfapump® DSR Potential chronic therapy for heart failure patients that are not well controlled on diuretics Direct Sodium Removal 1 alfapump system Implanted Port 3 Implanted port 2 4 11 11
Slide 12: RED DESERT
RED DESERT Repeated dose proof-of-concept study of the alfapump® DSR in diuretic-resistant heart failure patients • Patient enrolment resumed Safety: absence/rate of device, procedure and/or therapy related serious adverse events • Interim results (up to 5 patients) expected in Q4 2020 Feasibility:
Slide 13: Continued growth in European commercial sales
Continued growth in European commercial sales Refined focus on key markets H1 2020 revenue up +44% vs H1 2019 in K€ 700 600 +44% 500 400 300 200 100 0 H1 H2 2019 2020 13 13
Slide 14: Key Financial Results H1 2020
Key Financial Results H1 2020 Revenue: €595K (+ 44%) • Strong growth in Germany and France Operating expenses: - €9,397K (+ 31%) • Ongoing Clinical studies and associated Supply Chain costs Net result: - €9,554K Cash position of €14.9M at end of H1 2020 Post period: Cash runway extended • Repayment
Slide 15: €7.3M Debt Financing in July 2020
€7.3M Debt Financing in July 2020 • Three-year subordinated unsecured loan • Straight loan of €5.9M (6% interest) • Convertible part of €1.4M (5% interest) • in the event of an equity financing or sale of the Company • at 75% of the price of the Company's shares as will be reflected in the equity fi
Slide 16: Expected Core Value Drivers & Outlook
Expected Core Value Drivers & Outlook Outlook: Objectives: Q1 21: H1 21: Q1 22: Liver disease / NASH in NA Obtain regulatory approval of the POSEIDON POSEIDON POSEIDON alfapump® for treatment of enrolment interim primary endpoint recurrent and refractory ascites and completion results read-out comme
Slide 17: Q&A
Q&A