Slide 1: 2018 Full Year Results & 2019 Outlook
2018 Full Year Results & 2019 Outlook 4 April 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: Disclaimer
Disclaimer 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 th
Slide 4: Agenda
Agenda Executive Summary Our Company Major achievements Corporate & Financial highlights Outlook 2019 Q&A 4 4
Slide 5: Executive Summary
Executive Summary Important third party endorsements Significant progress in heart failure • Included in EASL clinical guidelines programme • Improved NICE recommendation • Pre-clinical proof-of-concept achieved • FDA Breakthrough device designation • First-in-human study ongoing Additional clinical
Slide 6: our company.
our company. Innovators in the management of liver disease, heart failure, malignant ascites & other fluid imbalance disorders 6
Slide 7: Commercial stage medtech positioned for long-term growth
Commercial stage medtech positioned for long-term growth Focus alfapump® on liver disease and heart failure – proven step change in the management of liver large and growing markets refractory ascites and malignant ascites; over 700 devices implanted FDA Breakthrough Device Designation alfapump® DSR
Slide 8: Liver disease and heart failure
Liver disease and heart failure Large and growing markets driven by unhealthy lifestyles and ageing populations Chronic liver disease/NASH Heart failure (HF) 3.9m adults 6.5m adults living with chronic liver DRIVEN BY impacted in the US2 disease in the US1 CHANGING DEMOGRAPHICS UNHEALTHY DIET OBESIT
Slide 9: Key themes of our focus markets
Key themes of our focus markets • Growing prevalence of NASH Liver • Trend to “mainstream disease” will drive need for novel device therapies • Smaller market but clear patient need Cancer • Untapped patient population to date • $13bn annual cost of US hospitalisations Heart Failure • Clear unmet ne
Slide 10: major achievements.
major achievements. alfapump® – refractory liver ascites and malignant ascites 10
Slide 11: Increased awareness and clinical evidence
Increased awareness and clinical evidence Important third-party endorsements • Included in EASL clinical practice guidelines for decompensated cirrhosis • Updated UK NICE recommendation for treatment of refractory liver ascites under special arrangements • Granted breakthrough device designation by
Slide 12: Clear increase in clinical outcomes
Clear increase in clinical outcomes 500 450 Average duration of alfapump therapy 400 Average 350 duration on 300 alfapump days 250 therapy 200 150 exceeding 450 100 days 50 0 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 Q1 2013 2013 2014 2014 2015 2015 2016 2016 2017 2017 2018 2018 2019 12 12
Slide 13: Focused European commercial activities
Focused European commercial activities Direct markets Distributor markets Additional clinical evidence Built targeted commercial team Focus on specialist centers Raise awareness at community hospital level 13 13
Slide 14: Rapidly moving to POSEIDON kick-off
Rapidly moving to POSEIDON kick-off Strong Progress FDA breakthrough device designation in January ‘19 Several pre-submission meetings with FDA Pivotal study for Advanced study design discussions Support from Key Opinion Leaders approval of the CRO selected alfapump in On Track North Ameri
Slide 15: major achievements.
major achievements. alfapump® DSR – volume overload in heart failure
Slide 16: Direct sodium removal (DSR)
Direct sodium removal (DSR) Breakthrough therapy tackling sodium removal directly Volume overload Removing the Elimination of in heart failure sodium (DSR) excess fluid 16 16
Slide 17: alfapump DSR
alfapump DSR Fully implanted and convenient system leveraging on the alfapump experience Administer infusate to the peritoneal cavity Infusate extracts sodium from the body Remove extracted sodium from peritoneal cavity Implanted Port Body restores balance by eliminating excess fluid 17 17
Slide 18: DSR: pre-clinical Proof-of-Concept delivered
DSR: pre-clinical Proof-of-Concept delivered Absolute sodium removal after 2 hour dwell 18 N=5 p<0.0001 16 Recommended 14 weekly sodium intake1 Clinically Sodium (g) 12 10 relevant 8 N = 10 6 removal of 4 2 Recommended daily sodium sodium intake 0 mean healthy pigs mean HF pigs Source 1: Weekly reco
Slide 19: DSR: First-in-Human Proof-of-Concept study underway
DSR: First-in-Human Proof-of-Concept study underway – On track for initial results in H1 ‘19 • Conducted by Dr. Testani at Yale University • Up to 20 human subjects, peritoneal dialysis (“PD”) patients with peritoneal catheter • Cross-over design: D10 DSR infusate vs. standard PD solution • 1 litre
Slide 20: corporate & financial highlights.
corporate & financial highlights. 20
Slide 21: Strong organisation
Strong organisation Highly experienced leadership team Executive team: Ian Crosbie Kirsten Van Martijn Blom Chief Executive Officer Bockstaele Chief Commercial Officer Chief Financial Officer Gijs Klarenbeek Dirk Fengels Timur Resch1 Chief Medical Officer Vice President Engineering Global VP QM/QA/R
Slide 22: Move to Belgium
Move to Belgium • Headquarters moved to Technologiepark in Ghent • Building the Ghent team rapidly: Corporate, Finance, Clinical & Commercial • Collaborating with Belgian KOLs across all our disease areas 22 22
Slide 23: Much strengthened balance sheet
Much strengthened balance sheet • Q4 2018: €8.5 million through private financing round including existing investors plus Newton Biocapital, PMV and SFPI-FPIM • Q1 2019: €27.5 million through IPO on Euronext Brussels 23 23
Slide 24: Financial results 2018
Financial results 2018 in Thousand Euros FY 2018 FY 2017 Variance Revenue 1,029 1,304 -21% Cost of goods sold (158) (212) -25% Gross margin 871 1,092 -20% Sales & Marketing (2,445) (1,506) +62% Clinical (1,671) (1,749) -4% Quality & Regulatory (1,372) (1,225) +12% Supply Chain (964) (1,041) -7% Engi
Slide 25: outlook & key catalysts.
i , outlook & key * catalysts. a)
Slide 26: Three platforms for growth
Three platforms for growth Balancing risk and reward North American North America & Europe Liver & Cancer Heart Failure Clinical feasibility study (MOSAIC) Animal studies (Yale University) FDA breakthrough device status First in human studies: single dose (underway) and repeated dose with POSEIDON c
Slide 27: Upcoming news flow
Upcoming news flow Key catalysts and development milestones Completion of DSR study in pig heart failure model & presentation of results Presentation of clinical data on 17 malignant ascites patients in retrospective clinical study H2 2018 Outcome of NICE review of alfapump® Initiation of First in H
Slide 28: Q&A
Q&A