Sequana Medical N.V · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (June 2023)
32 slides from Sequana Medical's investor presentation, Jun 16, 2023
Slide 1: Pioneers in the treatment of fluid overload
Pioneers in the treatment of fluid overload Liver disease, Heart failure & Cancer Investor presentation – June 2023 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: Large commercial markets with clear unmet needs
Large commercial markets with clear unmet needs • Proprietary technologies meeting large and unmet clinical needs • Key clinical problem in liver disease, heart failure, renal failure and cancer • We are not replacing diuretics – we target patients for whom diuretics are not effective • Diuretic-res
Slide 4: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump study – POSEIDON Liver disease / Q4 ‘22: Q2 ‘23: Q3‘23: Q4 ‘23: NASH Primary endpoint Additional data Data patient FDA submission readout at EASL preference study & for US approval NACSELD registry H2 H1 H2 2022 2023 2023 Q4 ‘22: Q2 ‘23: He
Slide 5: alfapump
alfapump® Proven step change in the treatment of liver refractory ascites
Slide 6: alfapump
alfapump Eliminating fluid from the peritoneal cavity – working in partnership with the bladder Fully implanted Easy implantation Long-term implantation & catheter Automatic operation patency Wireless battery charging Moves up to 4 litres / day Settings wirelessly adjusted Virtually non-clogging Rem
Slide 7: Refractory ascites – key complication of liver cirrhosis
Refractory ascites – key complication of liver cirrhosis Fatty liver disease / NASH is driving dramatic growth and change in attitudes to liver cirrhosis patients Typical patient life(1) Viral Alcoholic Liver infections “Normal Life” Disease (Hepatitis B & C) ~5 days Non-Alcoholic Steatohepatitis De
Slide 8: Existing therapies have clear limitations
Existing therapies have clear limitations Drainage (Large Volume Transjugular Intrahepatic Paracentesis / LVP) Portosystemic Shunt (TIPS) Painful, Poor Quality of Complications, Life, Short Term Benefit Contraindications Permanent Catheter System Liver transplantation External Catheter, High Cost, R
Slide 9: alfapump – strong clinical and economic rationale
alfapump – strong clinical and economic rationale Over 950 implants and hundreds of years of patient experience • Reduced burden of disease • Improved patient quality of life • Cost savings for hospitals and payers Estimated treatment cost / patient*: LVP: ~$66K alfapump: ~$37K Breakthrough Device D
Slide 10: Large and growing North American market
Large and growing North American market NASH is forecast to drive significant growth for many years – and is changing attitudes to cirrhosis 12+ paracentesis / year 3-5 paracentesis 78,000 6-7% CAGR / year patients with recurrent or >$2.5 Bn refractory ascites alfapump addressable due to liver cirrh
Slide 11: POSEIDON – North American pivotal study
POSEIDON – North American pivotal study Pivotal Cohort of 40 patients implanted with the alfapump alfapump Primary Secondary Enrolment implantation endpoint endpoints 3 months 3 months 3 months // 18 months // Pre-implant Post-implant Post-implant Long-term follow-up observation stabilisation
Slide 12: POSEIDON – successful North American pivotal study
POSEIDON – successful North American pivotal study 40 patients with recurrent or refractory ascites due to liver cirrhosis implanted with the alfapump Primary effectiveness endpoints exceed predefined thresholds for study success • 100% median per-patient reduction in therapeutic paracentesis (p<0.0
Slide 13: Gearing up for US approval in 2024
Gearing up for US approval in 2024 Existing DRG payment and breakthrough device designation de-risk reimbursement of alfapump Publications Additional data US filing & approval Submit POSEIDON data for Patient preference study: top-line data PMA filing planned for Q4 2023 publication in peer-reviewed
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 125 adult centres, of which 90 cover 95% of transplants ~50 commercial team initially Source: Organ Procurement & Transplantation Network, US Dept of HHS (optn.tran
Slide 15: DSR
DSR® Disease-modifying heart failure drug therapy
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: Direct Sodium Removal (DSR)
Direct Sodium Removal (DSR) 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 from body to restore
Slide 18: DSR – disease-modifying heart failure drug therapy
DSR – disease-modifying heart failure drug therapy RED DESERT and SAHARA deliver clinical proof-of-concept with long-lasting clinical benefits Clinically meaningful decongestion and durable improvements in cardio-renal health Safe, effective and rapid elimination of fluid overload / restoring euvo
Slide 19: Long-term improvement in cardio-renal status
Long-term improvement in cardio-renal status Durable and dramatic reduction in oral loop diuretic dosing as a result of improved disease status 600 ~23 months follow-up mg furosemide equivalents 500 RED DESERT 400 101-001 101-002 300 101-003 200 101-005 101-006 100 101-007 0 101-008† 800 700 ~15 mon
Slide 20: DSR 2.0 has improved therapeutic and safety profile
DSR 2.0 has improved therapeutic and safety profile Strong granted IP drives high margin recurring revenue stream DSR 1.0 DSR 2.0 Sodium-free D10% (off-the-shelf) Sodium-free dextrose / icodextrin (proprietary) Clinical proof-of-concept Improved therapeutic profile Rapid clinical path Favora
Slide 21: MOJAVE – Phase 1/2a randomized controlled US study
MOJAVE – Phase 1/2a randomized controlled US study Seeking to replicate SAHARA outcomes in randomised study of US patients with DSR 2.0 Safety of DSR 2.0 demonstrated in GLP animal and Phase 1 clinical studies US IND cleared by FDA 4 weeks 3 months DSR therapy (up to daily) Safety follow-up period
Slide 22: MOJAVE – initial data expected in Q4 2023
MOJAVE – initial data expected in Q4 2023 Top-line data in mid 2025 intended to deliver the clinical data package for partnering 2023 2024 2025 Non-randomized cohort Randomized cohort (N=3) (N=30) INDbyclearance FDA DSMB approval Initial Interim Top-line data* data data Endpoints • Safety: rate of
Slide 23: Multi-billion commercial opportunity for DSR
Multi-billion commercial opportunity for DSR Potential for premium DSR pricing through reduced hospitalization and improved survival • ~400K chronically congested HF patients hospitalized per year in the US and EU (“frequent flyers”) • High cost patients with major burden on healthcare systems, payo
Slide 24: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 25: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump study – POSEIDON Liver disease / Q4 ‘22: Q2 ‘23: Q3‘23: Q4 ‘23: NASH Primary endpoint Additional data Data patient FDA submission readout at EASL preference study & for US approval NACSELD registry H2 H1 H2 2022 2023 2023 Q4 ‘22: Q2 ‘23: He
Slide 26: Leader in large and growing markets with unmet needs
Leader in large and growing markets with unmet needs alfapump® in liver disease – market potential growing to over $2.5 billion by 2035(1) • NASH is changing liver cirrhosis market and driving strong growth • Approved in EU / FDA breakthrough device status / Strong IP portfolio • North American pivo
Slide 27: Contact info
Contact info [email protected] +32 498 053579 www.sequanamedical.com
Slide 28: Back-up
sequanamedical
Slide 29: Sequana Medical NV
Sequana Medical NV Founded in 2006 Gent, Belgium (HQ): corporate, clinical, commercial Zurich, Switzerland: manufacturing, engineering, QA/RA ~60 employees Euronext Brussels: SEQUA 29 29
Slide 30: Shareholders base and financial overview
Shareholders base and financial overview Ticker: SEQUA – Euronext Brussels • Outstanding shares: 28.2M • Outstanding shares corresponding to outstanding share options: 3.9M • Analysts: • Degroof Petercam – Laura Roba • Edison – Pooya Hemami • H.C. Wainwright – Yi Chen • KBC Securities – Jeroen Van d
Slide 31: Strong organisation
Strong organisation Highly experienced leadership team supported by committed and well-reputed shareholders Executive team: Ian Crosbie Kirsten Van Bockstaele Oliver Gödje Dragomir Lakic Chief Executive Officer Chief Financial Officer Chief Medical Officer VP Manufacturing Gijs Klarenbeek Martijn Bl
Slide 32: Leading experts as Heart Failure Scientific Advisors
Leading experts as Heart Failure Scientific Advisors Dr. Maria Rosa Costanzo Dr. Wilson Tang Medical Director of the Edward Center for Professor of Medicine at Cleveland Clinic Lerner Advanced Heart Failure College of Medicine at Case Western Reserve Medical Director Heart Failure Research for the U