Sequana Medical N.v · EURONEXT:SEQUA
Sequana Medical — Investor Presentation (November 2022)
48 slides from Sequana Medical's investor presentation, November 2022
Slide 1: Pioneers in the treatment of drug-resistant fluid overload
Pioneers in the treatment of drug-resistant fluid overload liver disease, heart failure & cancer Investor presentation – November 2022 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: Strongly positioned in two large markets
Strongly positioned in two large markets • Proprietary technologies treating diuretic-resistant fluid overload • Key clinical problem in liver disease, heart failure, renal failure and cancer • Diuretic-resistance is common – alternatives have significant disadvantages • Strong granted IP portfolio
Slide 4: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump® study – POSEIDON Liver disease / H2 23: NASH Q4 22: primary endpoint FDA submission readout for US approval H2 H1 H2 H1 2022 2023 2023 2024 Q4 22: Heart failure Q1 23: H1 23: H2 23: mid 24: top-line results IND filing Start study Interim
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: Limitations of existing therapies
Limitations of existing therapies Drainage (“Large Volume Transjugular Intrahepatic Paracentesis / LVP”) Portosystemic Shunt (TIPS) Painful, Poor Quality of alfapump Complications, Life, Short Term Benefit Contraindications Permanent Catheter System Liver transplantation External Catheter, High Cost
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 QoL • Cost savings for hospitals and payers Estimated treatment cost / patient*: LVP: ~$43K alfapump®: ~$35K ~$1.8K / LVP(1) ~$25K / alfapump 1
Slide 10: 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 observ
Slide 11: POSEIDON: Primary effectiveness endpoints met
POSEIDON: Primary effectiveness endpoints met Results substantially exceeded the predefined thresholds for study success Pivotal Cohort N = 40 %* p-value** 1. Frequency of Therapeutic Paracentesis (TP) a. median per-patient ratio 100% reduction P<0.001 b. mean per-patient ratio 82% reduction Not app
Slide 12: POSEIDON: Primary safety endpoint in line with expectations
POSEIDON: Primary safety endpoint in line with expectations Primary safety endpoint (pivotal cohort N = 40): • Combined rate of i) open surgical re-intervention due to pump system-related AE or to restore pump functionality, ii) pump explant (without replacement) due to pump system-related AE, or ii
Slide 13: North American alfapump approval expected in 2024
North American alfapump approval expected in 2024 2022 2023 2024 POSEIDON Completion Primary Secondary alfapump endpoint endpoint implants readout readout PMA submission US Launch US Commercial Scale-Up Head of Clinical Sales N. America specialists Reps NTAP for breakthrough devices de-risks rei
Slide 14: Large and growing North American patient population
Large and growing North American patient population NASH is forecast to drive significant growth for many years – and changing attitudes to cirrhosis North American patients with Over Over recurrent or 6 – 7% annually 60,000 140,000 refractory ascites due to liver cirrhosis 2022 2032 • NASH is a key
Slide 15: US – Go direct to liver transplant centers
US – Go direct to 140 liver transplant centers Highly efficient approach to target doctors and patients – driven by treatment guidelines 140 ~50 initially - 35 sales reps - 10 clinical specialists - 5 corporate 15 15
Slide 16: DSR
DSR® Disease-modifying heart failure drug therapy
Slide 17: Congestion is driver of morbidity and hospitalization
Congestion is driver of morbidity and hospitalization Diuretic-resistance is common and there are few effective clinical alternatives US hospitalizations HF – hospitalizations annually due to ~1m 90% due to fluid overload HF(3) (AKA congestion)(3) c.5d Typical Annual costs of US hospital stay(4) HF-
Slide 18: 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 19: RED DESERT: Successful proof-of-concept study
RED DESERT: Successful proof-of-concept study 8 euvolemic HF patients on high dose diuretics treated with DSR 3x per week up to 6 weeks Highly effective management of fluid and sodium balance • Generally safe and well tolerated; no clinically relevant hyponatremia Significant improvement in cardio-r
Slide 20: SAHARA: Expanding into decompensated patients
SAHARA: Expanding into decompensated patients 10 evaluable diuretic-resistant HF patients with persistent congestion on 2-6 weeks of intensive DSR therapy1 Safely, effectively and rapidly eliminate persistent congestion & restore euvolemia • All patients achieved euvolemia within one week of intensi
Slide 21: Long-term & major reduction in loop diuretic dosing
Long-term & major reduction in loop diuretic dosing Clear demonstration of improvement in cardio-renal health – driving improved clinical outcomes 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
Slide 22: Consistently improved NYHA class at least one level
Consistently improved NYHA class at least one level RED DESERT SAHARA 4IV 4 IV 3 III 3III NYHA Class NYHA Class 2 II 2II 1I 1I 0 0 101-001 101-002 101-003 101-005 101-006 101-007 101-008 01-01 01-03 01-04 01-05 01-06 01-08 01-09 01-10 01-11 01-12 • at screening • post DSR* * Post DSR = end of phase
Slide 23: Strong reduction in predicted mortality
Strong reduction in predicted mortality Over 75% reduction in predicted one-year mortality based on Seattle Heart Failure Model* • Seattle Heart Failure Model is a highly validated model to predict survival in heart failure • Validated in approx. 10,000 heart failure patients in over 46 countries wi
Slide 24: Moving to proprietary DSR 2.0
Moving to proprietary DSR 2.0 Improved clinical and safety profile driving 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 Favorabl
Slide 25: MOJAVE as package for DSR partnering
MOJAVE as package for DSR partnering Leveraging the strengths of established HF player to realise commercial potential of DSR 2021 2022 2023 2024 DSR 1.0 - Phase 2a study SAHARA - Proprietary DSR 2.0 product development CMC - GLP animal studies (safety) DSR 2.0 - YUKON & CHIHUAHUA first-in-human stu
Slide 26: Multi-billion market opportunity
Multi-billion market opportunity Delivering value 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, payors and patients • Value based
Slide 27: Outlook
Outlook Strong near term value drivers with clear long term potential
Slide 28: Strong outlook for value drivers
Strong outlook for value drivers North American alfapump® study – POSEIDON Liver disease / H2 23: NASH Q4 22: primary endpoint FDA submission readout for US approval H2 H1 H2 H1 2022 2023 2023 2024 Q4 22: Heart failure Q1 23: H1 23: H2 23: mid 24: top-line results IND filing Start study Interim
Slide 29: Strongly positioned for growth in both our markets
Strongly positioned for growth in both our markets alfapump® in liver disease – market potential growing to over $2 billion by 2032(1) • NASH is changing liver cirrhosis market and driving strong growth • FDA breakthrough device status / Strong IP portfolio • North American pivotal study – reported
Slide 30: Contact info
Contact info IR@sequanamedical.com +32 498 053579 www.sequanamedical.com
Slide 31: Back-up
sequanamedical
Slide 32: 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 32 32
Slide 33: 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 34: Shareholders base and financial overview
Shareholders base and financial overview Ticker: SEQUA – Euronext Brussels • Outstanding shares: 23.7M • Outstanding shares corresponding to outstanding share options: 2.7M • Analysts: • Degroof Petercam – Laura Roba • Edison – Pooya Hemami • H.C. Wainwright – Yi Chen • KBC Securities – Jeroen Van d
Slide 35: POSEIDON – Pivotal cohort
POSEIDON – Pivotal cohort More than 1/3 of patients implanted with the alfapump® had NASH or combined NASH etiology alfapump therapy still ongoing at day 180 post-implant Actual data used Implanted with Evaluable for primary N = 26 Enrolled in alfapump effectiveness endpoint Pivotal Cohort at 6 mont
Slide 36: POSEIDON: Observed data from patients completing alfapump therapy through day 180
POSEIDON: Observed data from patients completing alfapump® therapy through day 180 post-implant* N = 26 % 1. Frequency of TP a. median per-patient ratio 100% reduction b. mean per-patient ratio 93% reduction 2. Proportion of patients with a 50% reduction in number of TP post- vs pre- 92% of patients
Slide 37: POSEIDON: Observed data from patients completing alfapump therapy through day 180
POSEIDON: Observed data from patients completing alfapump® therapy through day 180 post-implant* Distribution of reduction in Therapeutic Paracentesis post-implant vs pre-implant (N = 26) * These observed patient data are not part of the main primary effectiveness endpoint analysis. 37 37
Slide 38: Roll-In Cohort: Patient profile
Roll-In Cohort: Patient profile 26 patients with recurrent or refractory ascites N. American patients are Age (mean) 63 y treated early in MELD score (mean ± SD) 10.3 ± 3.9 their disease Cirrhosis etiology - Alcohol - 50.0% NASH is - NASH - 23.1% becoming a major - NASH / Alcohol - 3.8% driver of as
Slide 39: Roll-In Cohort: Clinically important improvement in quality of life
Roll-In Cohort: Clinically important improvement in quality of life maintained up to 12 months Physical Component Score Higher is better SF-36 General health- survey questionnaire Total Score Ascites Q Specific health- survey questionnaire for ascites Lower is better 39 39 * Clinically important imp
Slide 40: Interim POSEIDON: 70% survival at 12 months
Interim POSEIDON: 70% survival at 12 months* Compares favourably to published literature Published literature cited in AASLD practice guidelines: survival rate for refractory ascites patients of only 50% at 12 months1 *Preliminary survival rate analysis of Roll-In Cohort (25 March 2022) 40 40 Source
Slide 41: 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
Slide 42: DSR therapy treatment overview
DSR® therapy treatment overview DSR Drug Step 1: Peritoneal catheter placement bag Step 2: DSR treatment episode 1. Infusion of DSR Drug 2. 24 hour dwell 3. Drainage DSR • Week 1: 5x DSR therapy Drug • Week 2-4: 3x/week DSR therapy Step 3: Catheter removal DSR Drug + sodium drain bag 42 42
Slide 43: RED DESERT – The first repeated DSR therapy study
RED DESERT – The first repeated DSR® therapy study Repeated dose proof-of-concept study of alfapump DSR® in stable heart failure patients on high dose diuretics alfapump® + surgical start DSR therapy discharged from end DSR port implantation in hospital hospital therapy 2 weeks 2 weeks 4 weeks DSR t
Slide 44: RED DESERT: Highly effective management of fluid & sodium
RED DESERT: Highly effective management of fluid & sodium No loop diuretics required during study despite mean baseline dose of >300 mg/day furosemide equivalents Ejection Fraction (%) NT-proBNP (pg/mL) Daily Dose of loop diuretics (mg)** During DSR Treatment Subject At baseline At baseline At basel
Slide 45: SAHARA: Ph. 2a in target patient population
SAHARA: Ph. 2a in target patient population Decompensated heart failure patients with persistent congestion on high dose diuretics Patient Start 1st Gen Euvolemic End DSR enrolment DSR® therapy state therapy Phase 1: Phase 2: Up to 3 x 2 weeks 16 weeks alfapump® + port Intensive DSR therapy Maintena
Slide 46: SAHARA: Safety
SAHARA: Safety No clinically relevant changes in serum sodium levels or progressive hyponatremia • 3 SAEs in 3 patients: • Blocked peritoneal catheter (phase 2) 2 in 2 patients DMC: related to study device but unrelated to implant procedure or treatment DMC: unrelated to study device, • Stable angin
Slide 47: Persistent congestion and Worsening renal function
Persistent congestion and Worsening renal function Persistent congestion and worsening renal function are key targets in decompensated heart failure Wattad et al, American Journal of Cardiology, 2015: interaction between worsening renal function and persistent congestion in acute decompensated heart
Slide 48: Evaluating potential for DSR in renal failure
Evaluating potential for DSR® in renal failure Complementary opportunity leveraging heart failure programme capabilities • Like heart failure, kidney failure / dialysis is one of the leading burdens for healthcare systems and carries a high mortality / morbidity burden • Hemodialysis seeks to tackle
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