Slide 1: FY2019 Financial Results & Business Update
FY2019 Financial Results & Business Update 19 March 2020
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: COVID-19 notice
COVID-19 notice Sequana Medical is closely following the evolution of the COVID-19 global health crisis and is in constant dialogue with its partners to assess the impact and adapt its operations as necessary. Although it is difficult to draw conclusions at this point on the systemic risk this disea
Slide 5: Agenda
Agenda Highlights Focus areas and Strategy Year in Review Financial Results 2019 Outlook 2020 Q&A 5 5
Slide 6: Highlights 2019 – 2020 YTD
Highlights 2019 – 2020 YTD FDA Breakthrough Device Designation for alfapump® First patient enrolled in alfapump POSEIDON pivotal study to support approval in North America Expected commercial launch of alfapump in US moved forward to H1 2022 Publication of pre-clinical and clinical proof-of-
Slide 7: 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 8: Strategy & Key Objectives
Strategy & Key Objectives • Obtain regulatory approval in North America for the alfapump® in treatment of recurrent and refractory liver ascites and commercialise through our own specialty salesforce • Advance clinical development of alfapump DSR in the treatment of volume overload due to heart fail
Slide 9: Year in Review: alfapump 2019 – 2020 YTD
Year in Review: alfapump® 2019 – 2020 YTD US CMS final ruling on new NTAP North America pathway for breakthrough devices Liver Transplantation published alfapump FDA Breakthrough Device FDA approval of First patient enrolled North American feasibility study Designation for the treatment POSEIDON piv
Slide 10: Strong progress in pursuing US approval (POSEIDON)
Strong progress in pursuing US approval 2019 2020 2021 2022 POSEIDON Primary endpoint: Proportion of patients FDA IDE First Last Interim Primary Final results* with a 50% reduction in approval patient in patient in* analysis* Endpoint (2° outcomes) average number of Reporting* paracentesis per mo
Slide 11: Self-commercialisation in US through specialty salesforce
Self-commercialisation in US through specialty salesforce NY MI (7) (4) PA (12) OH IL (6) (6) Initial focus on key CA (12) NC (3) transplant centres AZ (5) ~50 person team: GA (3) 35 sales reps, 10 clinical, TX (13) 5 corporate FL (8) POSEIDON site Target State (# transplant centres) 11 11
Slide 12: Year in Review: alfapump DSR 2019 – 2020 YTD
Year in Review: alfapump® DSR 2019 – 2020 YTD Clinical proof-of-concept of Appointment of four Circulation published positive single dose DSR therapy pre-eminent Heart Failure pre-clinical and clinical proof- Scientific Advisors of-concept data of DSR therapy alfapump DSR alfapump DSR 2019 2020 Posi
Slide 13: Clinical proof-of-concept of single dose DSR therapy
Clinical proof-of-concept of single dose DSR therapy Safe & well-tolerated Effective Consistent No significant discomfort 4-fold greater sodium removal than High degree of or adverse events the strongest commercially available consistency across peritoneal dialysis solution patients Minimal off-targ
Slide 14: RED DESERT started – First-In-Human Repeated Dose alfapump DSR study
RED DESERT started – First-In-Human Repeated Dose alfapump® DSR study • Up to 10 patients with heart failure on high dose diuretics across 2 centres (Belgium and Georgia) • Patients put on a low sodium diet without diuretics and implanted with alfapump DSR system • Evaluation of safety and feasibili
Slide 15: alfapump DSR development overview
alfapump® DSR development overview Study description 2019 2020 2021 2022 2023 Clinical proof-of-concept DSR therapy First in human DSR study: single dose, no alfapump Clinical proof-of-concept alfapump DSR ONGOING First in human alfapump DSR study*: repeated dose, with alfapump Partner (RED DESE
Slide 16: Financial Results 2019
Financial Results 2019 in Thousand Euros FY 2019 FY 2018 Variance Revenue 971 1,029 -6% Cost of goods sold (198) (158) +25% Gross margin 773 871 -11% Sales & Marketing (2,838) (2,445) +16% Clinical (3,922) (1,671) +135% Quality & Regulatory (1,817) (1,372) +32% Supply Chain (931) (964) -3% Engineeri
Slide 17: Outlook 2020 – Focus on POSEIDON and RED DESERT
Outlook 2020 – Focus on POSEIDON and RED DESERT • POSEIDON study • Recruitment completion (Q2) • Interim results (H2) • RED DESERT study • Initial results (Q2) • Final results (Q3) • ProMAS study • Start study (H1) • Recruitment completion (H2) • U.S. Feasibility study • Initiation (Q4) • Step Count
Slide 18: Q&A
Q&A
Slide 19: Back-up
sequanamedical
Slide 20: alfapump – management of liver refractory ascites and malignant ascites
alfapump® – management of liver refractory ascites and malignant ascites Over 750 implants and hundreds of years of patient experience Breakthrough Device Designation 20 20
Slide 21: Direct sodium removal (DSR)
Direct sodium removal (DSR) Remove the sodium and the body will eliminate the excess fluid Too much sodium Removing the sodium Elimination of excess drives fluid overload (DSR) fluid alfapump® Remove Administer Administer Infusate Infusate removes extracted Body restores Body restores infusateto inf
Slide 22: alfapump DSR
alfapump® DSR Fully implanted system for DSR therapy leveraging proven elements DSR 1 alfapump Implanted Port 3 Implanted port 2 4 Potential chronic therapy for heart failure patients that are not well controlled on diuretics 22 22