Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — CHF Solutions — Investor Presentation (September 2019)
28 slides from Nuwellis's investor presentation, Sep 24, 2019
Slide 1: Corporate Presentation
Corporate Presentation (NASDAQ: CHFS)September 24, 2019 For Investor Purposes Only: Not For Product Promotion
Slide 2: Forward-looking statements
This presentation contains forward‐looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act, as amended regarding our plans, expectations, beliefs, estimates, goals and outlook for the future that are intended t
Slide 3: Financial Highlights
Financial Highlights Shares * 2.7 million common shares (Nasdaq: CHFS) © Recent price: $2.20 (September 16, 2019) * Market cap: approximately $6.0 million Revenue © 9 consecutive quarters of double-digit growth * Year 2018 grew 41% vs 2017 * Q2 2019 up 53% from Q2 2018 and 38% from Q1 2019 Liquidity
Slide 4: Double-digit year-over-year quarterly growth for the last 9 quarters
4 We have delivered double-digit year-over-year quarterly growth for the last 9 quarters Financial Metrics We began selling our internally manufactured inventory in Q1 2019, driving substantial improvements in our gross margins Quarterly Revenue, YoY Growth YoY Growth Rates Q1 Q2 Q3 Q4 2018 15% 27%
Slide 5: Our Vision
Our Vision 5 We Are Dedicated To Changing The Lives Of Patients Suffering from Fluid Overload Through Science, Collaboration, And Innovation
Slide 6: What is Fluid Overload?
Excess fluid, primarily salt and water, builds up throughout the body resulting in weight gainCan result in ER admission, extended ICU stays, preventable deathCauses include:Heart Failure (HF)1Nephrotic Syndrome1Liver Damage1Kidney Damage1Pre- and Post-Cardiothoracic Surgery2,3,4Treatment for Burns
Slide 7: Fluid Overload Causes Significant Complications
Linked to mortality in critically ill patients1Associated with dangerous complications, such as1:Pulmonary EdemaCardiac FailureDelayed Wound HealingTissue BreakdownImpaired Bowl FunctionMay contribute to renal dysfunction, arrhythmias, and infection2 Fluid Overload Causes Significant Complications 1
Slide 8: Diuretics are the Standard of Care, but Fail to Provide Optimal Outcomes
Diuretics are the Standard of Care, but Fail to Provide Optimal Outcomes in Many Patients 1. Testani, Circ Heart Failure, 2016;9:e002370 2. Costanzo MR, et al., J Am Coll Cardiol., 2017; 69: 2428-45 68% show sub-optimal response, with 40% exhibiting diuretic resistance (“failure”)1Nearly 50% of HF p
Slide 9: Clinical Guidelines Support Use of Ultrafiltration
Clinical Guidelines Support Use of Ultrafiltration 1 Yancy CW, et al. J Am Coll Cardiol. 2013 Oct 15; 62(16): e147-e239.2 HFSA 2010 Comprehensive Heart Failure Practice Guidelines: Lindenfeld J, et al. J Card Fail. 2010 Jun; 16(6): 475 – 539.3 ESC Guidelines for the diagnosis and treatment of acute
Slide 10: Aquadex FlexFlow System: A Solution to this Unmet Clinical Need
Safe, effective, and clinically proven to remove excess salt and water from the body40% more fluid removal than conventional diuretic drug therapy over the same period of time1No clinically significant impact on electrolytes balance, blood pressure, or heart rate1,2Prescribed by any medical specialt
Slide 11: Aquadex FlexFlow Product Overview
Aquadex FlexFlow Product Overview Aquadex FlexFlow Console Dual Lumen venous catheter Blood Circuit Set 11
Slide 12: Target Segments & Addressable Opportunity (US)
Aquadex FlexFlow System for Fluid Management “Successful fluid overload treatment depends on precise assessment of individual volume status, understanding the principles of fluid management with ultrafiltration, and clear treatment goals.”1 Critical CareCV Surgery (VAD, CABG, HV)*Liver (Transplant,
Slide 13: Cardiovascular Surgery Market Opportunity
13 Cardiovascular Surgery Market Opportunity Over 500,000 US surgeries a year utilize heart-lung bypass machine including: 340,000 coronary artery bypass graft (CABG) procedures2 180,000 valve procedures3 4,000 ventricular assist device (VAD) implants4Patients are given fluid to facilitate surgery.
Slide 14: Heart Failure Market Opportunity
14 Heart Failure (HF) Market Opportunity Over 6 million people suffer from HF in the US1900,000 HF patients are hospitalized each year due to fluid overload268% show sub-optimal or no response to diuretics; 40% are diuretic resistant3Aquadex FlexFlow can turn a cost center into a profit center 1. ht
Slide 15: Pediatric Market Opportunity
15 Pediatric Market Opportunity Addressable market of 40,0001 patients for both chronic and acute fluid overload conditions, such as heart failure, cardiac surgery, ECMO therapy, transplantation and neonatal kidney replacement.Includes 11,0001 neonates born each year with compromised kidneys and a 5
Slide 16: Acute Need in Cardiac Surgery: Fluid Overload Associated with Greater Mortality
16 Acute Need in Cardiac Surgery: Fluid Overload is Associated with Greater Mortality Retrospective analysis on 1,358 patients who underwent cardiac surgeryGreater amount of IV fluid during cardiac surgery associated with three-fold increase is mortality at 90 days Fluid Overload is Associated with
Slide 17: Aquadex FlexFlow Provides Clinical and Economic Benefits in CV Surgery
Aquadex FlexFlow Provides Significant Clinical and Economic Benefits in CV Surgery Modified ultrafiltration reduces duration of assisted ventilation post cardiac surgery1,2,3 Aquadex FlexFlow not considered renal replacement therapy from a quality reporting standpointNo Nephrology consultation requi
Slide 18: Most US Hospitals Lose Money on a Heart Failure Admission
Most US Hospitals Lose Money on a Heart Failure Admission There is great concern throughout the US healthcare system regarding the high and growing economic burden for treating heart failure. Heart failure treatment is Medicare’s largest expenditure. Most US hospitals lose money on a heart failure a
Slide 19: Medicare Penalizes Hospitals with Excessive HF Readmissions
Medicare Penalizes Hospitals with Excessive HF Readmissions In 2012, the Affordable Care Act instituted the Hospital Readmission Reduction Program1Statistics: CMS shows 25% of heart failure patients are readmitted to the hospital within 30-daysRequirement: CMS to reduce payments to hospitals with ex
Slide 20: Economic Benefits of Using Aquadex FlexFlow in Inpatient Heart Failure
20 Economic Benefits of Using Aquadex FlexFlow in the Inpatient Heart Failure Setting Ultrafiltration has shown significant decreases in heart failure rehospitalizations and rehospitalization lengths of stay compared to diuretics1Recent analysis demonstrated a cost savings of $3,975 per patient when
Slide 21: Clinical Results Demonstrate the Potential of Aquadex FlexFlow
Clinical Results Demonstrate the Potential of Aquadex FlexFlow Good Samaritan Hospital-A Single Center Experience Independent study of 67 heart failure patients who received Aquadex FlexFlow therapy:No 30-day readmits for volume overloadLength of stay when started within 24 hours was 2.2 days, compa
Slide 22: Significant Opportunity in Heart Failure For Outpatient Setting
VA/Department Of Defense OpportunityGoal of VA/DOD health systems is to avoid HF hospital admissionsTampa VA conducting clinical study on outpatient use of Aquadex FlexFlow Q3/Q4 2019 initiation$6.5M blanket purchase agreement received for outpatient trial at Tampa VAHospital and Health System Oppor
Slide 23: Pediatrics: Providing a Solution in an Underserved Market
Pediatrics: Providing a Solution in an Underserved Market AcuteKidney replacement therapy (11,000 patients/yr) 1Cardiac surgery (10,000 procedures/yr) 2Extracorporeal membrane oxygenation (ECMO) therapy (6,000 procedures/yr) 3Solid organ transplantation (2,000 procedures/yr) 4ChronicHeart Disease (1
Slide 24: We Are Evaluating New Predictive Diagnostic Tools
Physicians need new diagnostic tools to better manage fluid overload to:Assess which patients are best candidates for ultrafiltrationTarget how much fluid to removeKnow when the patient is approaching dry weight and to discontinue ultrafiltrationWe are evaluating diagnostic technology internally and
Slide 25: Expanding Commercial Distribution
US direct sales team growing to 15 sales territories and 15 clinical education specialistsDistribution partners in UK, Italy, Germany, Spain, Singapore, Hong Kong, Thailand, India and BrazilFDA 510(k) market cleared in US; sold internationally with local regulatory approvalManufacturing all products
Slide 26: CHF Growth Metrics
270 Aquadex FlexFlow systems installed in 125 hospitalsOptimal utilization is 100 disposables per year per systemCurrent utilization is 16 percentCardiac hospital penetration <2 percentAddressable US market segments total >$2.0 billion annuallyAdditional opportunities beyond current markets include
Slide 27: CHF Solutions Investment Considerations
Rapidly growing, revenue generating, medical device companyExpanding commercial focus beyond initial market:Heart Failure: our largest market opportunity, pursing diagnostic opportunities to expand adoption. Increasing focus in outpatient hospital clinics and leveraging Tampa VA outpatient clinical
Slide 28: Thank you
chf solutions Thank you
CHF Solutions — Investor Presentation (September 2019) on 6ix