Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — CHF Solutions — IPO Roadshow (March 2019)
30 slides from Nuwellis's IPO roadshow presentation, Mar 1, 2019
Slide 1: Corporate Presentation March 2019
Corporate Presentation (NASDAQ: CHFS)March 2019 For Investor Purposes Only: Not For Product Promotion
Slide 2: Statement about Free Writing Prospectus
2 Statement about Free Writing Prospectus This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before investing in our company. E
Slide 3: Safe Harbor Statement
This presentation contains forward‐looking statements. All forward‐looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties. Various factors could cause actual results to differ materially from these statements including our abi
Slide 4: Our Vision
Our Vision Our mission is to improve the quality of life for patients suffering from fluid overload in acute and chronic conditionsThrough our commercial expansion efforts, we strive to be the global leader in fluid management solutions 4 Changing the Lives of Fluid Overloaded Patients with a Clinic
Slide 5: Upcoming Milestones
5 Upcoming Milestones Anticipated Milestones Expected Timing India distribution agreement initiated Q1 2019 Brazil distribution agreement initiated Q1 2019 Baycare hospital system (Florida) therapy Initiation (14 hospitals) Q1 2019 Baptist hospital system (Memphis) therapy Initiation (18 hospitals)
Slide 6: Significant Worldwide Market Opportunity
6 Significant Worldwide Market Opportunity Cardiovascular Surgery (CV surgery)Over 7 million cardiovascular operations and procedures are performed each year in the US1, including:340,000 coronary artery bypass graft (CABG) procedures2180,000 valve procedures34,000 ventricular assist device (VAD) im
Slide 7: The Market is Pulling Us Beyond Our Initial Target Segment
The Market is Pulling Us Beyond Our Initial Target Segment Market-Driven Approach New Heart Failure InpatientOutpatient New CV Surgery VADCABGValve ReplacementsTransplants New* Pediatrics Renal ReplacementHeart DiseaseCardiac SurgeryTransplantsECMO 7 *Subject to FDA clearance of label modification
Slide 8: CV Surgeons can help Aquadex FlexFlow gain a foothold in hospitals
CV Surgeons can help Aquadex FlexFlow gain a foothold in hospitalsLeverage surgical use to further penetrate heart failure market opportunity CV Surgery offers attractive market entry point:Surgeons generally possess a lot of “power” to initiate new therapiesTech savvy nurses/staffPatients already a
Slide 9: Acute Need in Cardiac Surgery: Fluid Overload Associated with Greater Mortality
9 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 3
Slide 10: 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 Ultrafiltration associated with decreases in certain post-operative complications4,5,6,7 Aquadex FlexFlow not considered ren
Slide 11: Pediatrics: Providing a Solution in an Underserved Market
Pediatrics: Providing a Solution in an Underserved Market Aquadex FlexFlow/ultrafiltration is currently being prescribed by physicians to treat various pediatric conditions:AcuteKidney replacement therapy for neonatal patients (11,000 patients/yr) Cardiac surgery (10,000 procedures/yr)Extracorporeal
Slide 12: Clinical Data: Pediatrics
Clinical Data: Pediatrics In critically ill pediatric patients with Acute Kidney Injury, fluid balance and hemodynamic stability are imperative to maintaining adequate intravascular volume to reduce the risk of increased morbidity and mortality primarily through Acute Kidney InjuryIn a pediatric stu
Slide 13: 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 Q2 2019 initiation$6.5M blanket purchase agreement received for outpatient trial at Tampa VAHospital and Health System Opportun
Slide 14: 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 15: Collaborating with Daxor to improve outcomes for fluid overloaded patients
We are collaborating with Daxor to improve outcomes for fluid overloaded patientsDaxor has published clinical trials demonstrating their BVA-100 provides significant benefit to assess fluid status₁:Unique actionable results: 98% accurate quantification of blood volume, plasma volume, and red cell vo
Slide 16: What is Fluid Overload?
Excess fluid, primarily salt and water, builds up throughout the body resulting in weight gainCan result in breathing distress and ER admissionCauses include:Heart Failure (HF)1Nephrotic Syndrome1Liver Damage1Kidney Damage1Pre- and Post-Cardiothoracic Surgery2,3,4Treatment for Burns or Trauma5 What
Slide 17: 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 18: 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 Program1Requirement: CMS to reduce payments to hospitals with excess readmissionsPenalty: hospitals can lose ≤3% of Medicare reimbursement on all admissions2017
Slide 19: Economic Benefits of Using Aquadex FlexFlow in Inpatient Heart Failure
19 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 20: Diuretics are the Standard of Care, but Fail in Many Patients
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 40% of patients demonstrate diuretic resistance (“failure”) and 68% show sub-optimal response1 Nearly
Slide 21: 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 22: Aquadex FlexFlow Product Overview
Aquadex FlexFlow Product Overview Aquadex FlexFlow Console Dual Lumen venous catheter Blood Circuit Set 22
Slide 23: 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 24: Aquadex FlexFlow Studied In More HF Patients Than All Other Ultrafiltration Systems
The Aquadex Flexflow System Has Been Studied In More HF Patients Than All Other Ultrafiltration Systems Combined Highest Level of Evidence: Level 1 (Randomized Clinical Trial)1 Study Name Study Design # of Patients Rationale Publication Date SAFE Multi-center, prospective, single-arm 21 IDE for 510k
Slide 25: 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 26: Expanding Commercial Distribution
US based direct sales force with 13 sales territories and 5 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 27: Quarterly Revenue, YoY Growth and Cash Burn
27 We have delivered double-digit year-over-year quarterly growth for the last 7 quarters Financial Metrics We have increased quarterly revenue and stabilized our cash utilization $ in thousands Quarterly Cash Burn $3,100 $5,000 $3,500 $3,300 $2,800 Quarterly Revenue, YoY Growth and Cash Burn
Slide 28: Capitalization as of December 31, 2018
Capitalization as of December 31, 2018 Common Shares Outstanding (Nasdaq CHFS) 513,445 Series F Convertible Preferred (1) 18,190 Options (weighted average exercise price $61.25) 140,546 Warrants (2) (weighted average exercise price $50.23) 599,293 RSUs 3 Fully Diluted Shares 1,271,477 Capitalization
Slide 29: 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 30: For More Information
Claudia Napal DraytonChief Financial Officer CHF Solutions, Inc. 952-345-4205claudia.drayton@chf-solutions.com -or- Bret ShapiroManaging PartnerCORE IR516-222-2560brets@coreir.com For More Information Investor Relations:CHF Solutions, Inc.ir@chf-solutions.com