Sequana Medical N.V · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (May 2024)
25 slides from Sequana Medical's investor presentation, May 2024
Slide 1: Pioneers in the treatment of fluid overload
Pioneers in the treatment of fluid overload Transforming lives in liver disease, heart failure & cancer Investor presentation – May 2024 Euronext: SEQUA.BR
Slide 2: 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 3: Targeting large markets with strong growth
Targeting large markets with strong growth Strong growth in NASH and unmet clinical needs in cardiorenal syndrome driving commercial opportunity alfapump – device for recurrent & DSR – novel drug treatment for refractory ascites due to liver cirrhosis cardiorenal syndrome in heart failure • $2.4 bil
Slide 4: Key upcoming value drivers
Key upcoming value drivers Targeting US commercial launch for alfapump and Ph II data / partnering agreement for DSR Medical Device Indication Development Pivotal Trial Approved Refractory liver & CE Mark / MDR approval Europe malignant ascites Recurrent or refractory FDA breakthrough device designa
Slide 5: alfapump
alfapump® Proven step change in the treatment of liver refractory ascites
Slide 6: Refractory ascites – key complication of liver cirrhosis
Refractory ascites – key complication of liver cirrhosis Fatty liver disease / NASH is driving strong growth and change in attitudes to liver cirrhosis patients Viral infections (Hepatitis B & C) Non-Alcoholic Steatohepatitis Alcoholic Liver Disease (NASH/MASH) Liver Ascites Refractory cirrhosis Asc
Slide 7: Clear limitations of treatment options
Clear limitations of treatment options No new development apart from NASH drugs, which are not effective in late stage NASH / cirrhosis SoC: Paracentesis (“drainage”) Permanent Catheter System Painful, burdensome, short term benefit, QoL impact External Catheter, Risk for Infections / “Normal Life”
Slide 8: $2.4bn market for alfapump - growing at 9% CAGR
$2.4bn market for alfapump - growing at 9% CAGR $600 million Priority One market – highest clinical burden, costs & QOL impact, and little competition Recurrent and refractory ascites prevalence (US and Canada) 160 147k 140 131k 119k 120 108k 99k Priority 3 100 3-5 paracenteses / year Patients 91k 8
Slide 9: Proven step change in therapy; over 1,000 implanted
Proven step change in therapy; over 1,000 implanted Fully implanted automatic device for long term treatment Wireless battery charging Breakthrough Device Designation Settings wirelessly adjusted Remote data monitoring Moves up to 4 litres / day Strong IP barriers through extensive patent portfolio,
Slide 10: Successful North American pivotal study
Successful North American pivotal study POSEIDON - Pivotal Cohort of 40 patients with recurrent or refractory ascites due to liver cirrhosis alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant sta
Slide 11: Sustained efficacy and robust safety profile
Sustained efficacy and robust safety profile 12 month data demonstrates effectiveness and safety Virtual elimination of needle paracentesis • Maintaining 100% median per-patient reduction in therapeutic paracentesis (N=19, p<0.001)* Robust safety profile despite disease progression • 2 pumps expla
Slide 12: PMA regulatory review significantly derisked
PMA regulatory review significantly derisked On track for Q1 2025 US approval and H2 2025 US commercial launch • All audits completed • Substantive review complete – no further new clinical or pre-clinical questions • Day 90 (“major deficiencies”) letter received and Day 100 meeting held • Response
Slide 13: Attractive pricing with derisked reimbursement
Attractive pricing with derisked reimbursement Existing DRG & CPT III codes - NTAP and TCET benefit from Breakthrough Device Designation Coding – Strong position from existing DRG codes and Breakthrough Designation • Existing US hospital DRG payment for alfapump procedure of $60-70K in target hospit
Slide 14: US – Go direct to liver transplant centers
US – Go direct to 90 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines Targeting annualized revenues of over €35MM within 3 years of full commercial Cover 95% of liver transplants launch • Estimated cash required of ~€80MM* Cashflow br
Slide 15: DSR
DSR® Disease-modifying heart failure drug therapy tackling cardiorenal syndrome (CRS)
Slide 16: Congestion is key driver of morbidity & hospitalization
Congestion is key driver of morbidity & hospitalization Diuretic-resistance in heart failure is common and there are few effective clinical alternatives US hospitalizations HF hospitalizations annually due to ~1m 90% due to fluid overload heart failure (HF)(3) (AKA congestion)(3) c.5d Typical Annual
Slide 17: Cardiorenal Syndrome – key clinical challenge in HF
Cardiorenal Syndrome – key clinical challenge in HF Clear need for options to tackle congestion for long enough, without the problems of loop diuretics • Combined, and self-reinforcing dysfunction of heart and kidneys with hypothesised complex and interconnected mechanisms • Clinical profile of self
Slide 18: Multi-billion commercial opportunity
Multi-billion commercial opportunity ~400K chronically congested HF patients hospitalized per year in the US and EU (“frequent flyers”) EU US $45K >$9 Bn 200K 200K US annual HF DSR addressable market patients patients hospitalization cost in US per patient Potential for premium DSR pricing through r
Slide 19: DSR (Direct Sodium Removal) targets key driver
DSR (Direct Sodium Removal) targets key driver Eliminating fluid spread across the body – working in partnership with the kidneys 1 Sodium-free DSR product 2 Sodium diffuses from 3 DSR product + extracted 4 Body eliminates free water administered to peritoneal body into DSR product sodium removed fr
Slide 20: Clinical proof of concept in cardiorenal syndrome
Clinical proof of concept in cardiorenal sydrome Rapid and effective decongestion PLUS improvement in cardio-renal status Strong results from RED DESERT (N = 8) and SAHARA (n = 10) clinical studies Replacement of loop diuretics; safe, rapid and effective decongestion and maintenance of euvolemia N
Slide 21: Improvement in diuretic response and renal function
Improvement in diuretic response and renal function Normalization of diuretic-response with dramatic durable reduction in LD needs post-DSR therapy Cumulative 6-hour urine output and urinary sodium excretion following an intravenous 40mg dose of furosemide Blood urea nitrogen (BUN) and creatinine cl
Slide 22: MOJAVE – Phase 1/2a randomized controlled US study
MOJAVE – Phase 1/2a randomized controlled US study Seeking to replicate RED DESERT and SAHARA positive results in US patients 4 weeks 3 months (initial follow-up at 30 days) DSR therapy (up to daily) + optimized usual care vs. Safety follow-up period IV loop diuretic + optimized usual care Endpoints
Slide 23: MOJAVE: Strong data from non-randomised patients
MOJAVE: Strong data from 3 non-randomised patients Data from first randomised cohort planned for H2 ’25; top-line data expected H2 ’26 for partnering • Safe, well tolerated and maintenance of euvolemia without loop diuretics • Virtual elimination of loop diuretics three months post-DSR therapy • Dra
Slide 24: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 25: Strong near-term value inflection points
Strong near-term value inflection points • US FDA approval expected Q1 ’25 • US commercial launch H2 2025 • Interim results expected H2 ’25 and top-line data in H2 ’26 • Partnering following completion of MOJAVE study 25