Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — H1 2019 Earnings Presentation
27 slides from Sequana Medical's earnings presentation, Sep 25, 2019
Slide 1: 2019 Half Year Results & Year-to-date Business Update
2019 Half Year Results & Year-to-date Business Update 25 September 2019
Slide 2: Today's presenters
Today’s presenters Ian Crosbie Gijs Klarenbeek Kirsten Van Bockstaele Chief Executive Officer Chief Medical 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: Agenda
Agenda Executive Summary Our Company Update on alfapump® and alfapump® DSR Corporate & Financial Highlights Outlook & Value Drivers Q&A 4 4
Slide 5: Executive Summary
Executive Summary Strong progress across both liver disease and heart failure, our two pillars of growth alfapump® North America Breakthrough Device Designation from US FDA First patient enrolled in POSEIDON pivotal study to support marketing approval in US and Canada alfapump® DSR Clinical pr
Slide 6: Our Company
Our Company Innovators in the management of fluid overload liver disease - malignant ascites - heart failure 6
Slide 7: One platform – two products
One platform – two products platform alfapump® alfapump® DSR proven step change in liver refractory ascites and breakthrough approach to fluid overload in malignant ascites; heart failure; over 700 devices implanted clinical proof-of-concept of Direct Sodium Removal (DSR) Breakthrough Device Designa
Slide 8: Focus on US NASH and global heart failure markets
Focus on US NASH and global heart failure markets Large market opportunities with high unmet medical need Liver (NASH) in US Heart Failure in EU+US ~145 K patients / year ~400 K patients hospitalised / year with refractory ascites due to NASH within next 10-20y(1) for volume overload due to heart fa
Slide 9: alfapump North America
alfapump® North America sequanamedical
Slide 10: NASH drives US market attractiveness
NASH drives US market attractiveness Stronger competitive position in a much larger and dynamic market US EU | alfapump® market potential | ~€0.4 Bn / year > €3 Bn / year | Underlying disease | Alcoholic Liver Disease, Hepatitis NASH | Patient characteristic | “Outside mainstream” “Mainstream” | Ave
Slide 11: Clear progress in pursuit of North American approval
Clear progress in pursuit of North American approval Received Breakthrough Device Designation from the U.S. FDA for the alfapump® for the treatment of recurrent or refractory liver ascites Received unconditional IDE approval from the US FDA and ITA approval from Health Canada to start North Amer
Slide 12: First patient enrolled in POSEIDON study
First patient enrolled in POSEIDON study • Up to 50 patients implanted with the alfapump(1) across 15 centres • Primary endpoint at 9 months after enrollment: proportion of patients with a 50% reduction in average number of paracentesis per month post-implant vs pre-implant Pre-implant Post-implan
Slide 13: alfapump US approval roadmap
alfapump® US approval roadmap Key anticipated milestones 2019 2020 2021 2022 POSEIDON IDE & ITA First Last Topline results Final results approval patient in patient in (1° outcomes) (2° outcomes) US Regulatory FDA breakthrough Filing Approval, path designation followed by US launch Proposed CMS
Slide 14: alfapump DSR
p. alfapump® DSR sequanamedical
Slide 15: Volume overload in heart failure is a major problem and a key driver of costs
Volume overload in heart failure is a major problem and a key driver of costs 40% of heart failure patients are poorly controlled with diuretics $13 billion annual US cost of heart failure related Excess sodium drives hospitalisations of which ~90% fluid overload due to volume overload 15 15 Sources
Slide 16: Clinical proof-of-concept of DSR paves the way for our breakthrough approach
Clinical proof-of-concept of DSR paves the way for our breakthrough approach Primary and secondary endpoints met in first-in-human single dose DSR proof-of-concept study Results selected for late-breaking abstract session and highlights plenary session at Heart Failure 2019 Preparations underw
Slide 17: First-in-human single dose DSR proof-of-concept study
First-in-human single dose DSR proof-of-concept study DSR therapy was safe & well-tolerated with no adverse events or significant discomfort Substantially higher sodium removal with DSR vs standard Peritoneal Dialysis (PD) solution Minimal inter-patient variability 17 17 Note: Cross-over study: D
Slide 18: alfapump DSR leverages proven elements
alfapump® DSR leverages proven elements Combining clinical proof-of-concept of DSR with validated alfapump platform - Safe & well-tolerated DSR - Clinically relevant removal of sodium - Minimal patient inter-variability - Validated technical performance alfapump - Extensive clinical experience - D
Slide 19: alfapump Europe
alfapump® _ Europe sequanamedical
Slide 20: Continued scale up of our commercial activities in focus European territories
Continued scale up of our commercial activities in focus European territories Inclusion in German treatment guidelines (DGVS) for complications of liver cirrhosis Created referral networks of centres of excellence in Germany, Switzerland, France and UK Hired Therapy Development Managers Disc
Slide 21: Expanding clinical evidence in Europe
Expanding clinical evidence in Europe Preparing for patient enrolment in Prospective Malignant Ascites Study (ProMAS) Impact of alfapump® on quality of life in patients with malignant ascites Up to 40 patients across sites in Belgium, the UK and Switzerland First patient enrolled expected in
Slide 22: Corporate & Financial Highlights
Corporate & Financial Highlights 22
Slide 23: Strengthened leadership team and balance sheet
Strengthened leadership team and balance sheet Appointment of Medtech executive Jason Hannon to Board of Directors €27.5 million through IPO on Euronext Brussels in February 2019 23 23
Slide 24: 2019 half year results
2019 half year results in Thousand Euros HY 2019 HY 2018 Variance Revenue 413 447 -8% Cost of goods sold (86) (96) -10% Gross margin 327 352 -7% Sales & Marketing (1,306) (977) +34% Clinical (1,451) (749) +94% Quality & Regulatory (930) (564) +65% Supply Chain (368) (514) -28% Engineering (534) (548
Slide 25: Outlook & Value Drivers
rl Outlook & « Value Drivers a | sequanamedical
Slide 26: Strong news flow
Strong news flow Key anticipated milestones alfapump® received FDA Breakthrough Device designation alfapump included in German treatment guidelines (DGVS) for complications of liver cirrhosis H1 2019 Presented positive results of first-in-human single dose DSR study for volume overload in heart fail
Slide 27: Q&A
Q&A