Filed Pursuant to Rule 433 of the Securities Act of 1933
Registration Statement No. 333-229102
Issuer Free Writing Prospectus dated March 1, 2019
Corporate Presentation (NASDAQ: CHFS)March 2019 For Investor Purposes Only: Not For Product Promotion
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. Except as otherwise indicated, this presentation speaks only as of the date hereof.This presentation does not constitute an offer to sell, nor a solicitation of an offer to buy, any securities by any person in any jurisdiction in which it is unlawful for such person to make such an offering or solicitation.Neither the Securities and Exchange Commission (the “SEC”) nor any other regulatory body has approved or disapproved of our securities or passed upon the accuracy or adequacy of this presentation. Any representation to the contrary is a criminal offense.This presentation includes industry and market data that we obtained from industry publications and journals, third-party studies and surveys, internal company studies and surveys, and other publicly available information. Industry publications and surveys generally state that the information contained therein has been obtained from sources believed to be reliable. Although we believe the industry and market data to be reliable as of the date of this presentation, this information could prove to be inaccurate. Industry and market data could be wrong because of the method by which sources obtained their data and because information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties. In addition, we do not know all of the assumptions that were used in preparing the forecasts from the sources relied upon or cited herein.We have filed a Registration Statement on Form S-1 with the SEC, including a preliminary prospectus dated February 25, 2019 (the “Preliminary Prospectus”), with respect to the offering of our securities to which this communication relates. Before you invest, you should read the Preliminary Prospectus (including the risk factors described therein) and, when available, the final prospectus relating to the offering, and the other documents filed with the SEC and incorporated by reference into the Preliminary Prospectus, for more complete information about us and the offering. You may obtain these documents, including the Preliminary Prospectus, for free by visiting EDGAR on the SEC website at http://sec.gov.Alternatively, we or any underwriter participating in the offering will arrange to send you the prospectus if you request it by contacting Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, NY 10172, by calling (212) 409-2000 or by email at prospectus@ladenburg.com.
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 ability to execute on our commercial strategy and to grow our Aquadex FlexFlow® business, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our expectations regarding anticipated synergies with and benefits of the Aquadex FlexFlow business, and the other risks set forth under the caption “Risk Factors” and elsewhere in our periodic and other reports filed with the U.S. Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10‐K for the fiscal year ended December 31, 2018. We are providing this information as of the date of this presentation and do not undertake to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise. Although the Company believes that the forward‐looking statements are reasonable and based on information currently available, it can give no assurances that the Company’s expectations are correct. All forward looking statements are expressly qualified in their entirety by this cautionary statement.This presentation also contains estimates and other statistical data made by independent parties and by us relating to market shares and other data about our industry. These data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.Aquadex FlexFlow is a registered trademark of CHF Solutions, Inc. 3 Safe Harbor Statement
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 Clinically Proven Therapy
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) Q1 2019 FDA 510(k) submission for expanded use of Aquadex in pediatric population Q2 2019 First patient enrolled Tampa VA outpatient study Q2 2019 Memorial Herman (Texas) system therapy initiation (14 hospitals) Q2 2019 Clinical data from Daxor collaboration 2H 2019 FDA 510(k) approval of expanded use of Aquadex in pediatric population 2H 2019 Clinical publication of pediatric use of Aquadex in Acute Kidney Injury patients 2H 2019
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) implants4PediatricsApproximately 12,000 pediatric patients with heart failure5 and ~29,000 receiving cardiac surgery, ECMO therapy, renal replacement, and solid organ transplants6Heart Failure (HF)Over 6 million people suffer from HF in the US71 million patients hospitalized per year in the US for HF890% of HF patient hospitalizations are due to fluid overload868% show sub-optimal response to diuretics9 1. Circulation. 2014 January 21; 129(3): e28–e292. 2. https://idataresearch.com/new-study-shows-approximately-340000-cabg-procedures-per-year-in-the-united-states/. 3. https://idataresearch.com/over-182000-heart-valve-replacements-per-year-in-the-united-states/. 4. https://www.mdedge.com/chestphysician/article/148584/heart-failure/lvad-use-soars-elderly-americans . 5. Jayaprasad. Heart Views. 2016 Jul-Sep; 17(3): 92–99. 6. See slide 11 for references. 7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/. 8. Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. 9. Testani JM, et al. Circ Heart Failure. 2016;9(1). Worldwidemarket opportunity estimated at3x US market9
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
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 anticoagulated and have venous access line placed Fluid-in/fluid out known Leveraging Acute Need in CV Surgery for Chronic Need in Heart Failure CV Surgery ACUTE NEED Heart Failure CHRONIC NEED 8
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 300% Increase in 90 Day Mortality Rates Post CV Surgery Source: Pradeep, A. et al. HSR Proc IC and Car An. 2010 Mar; 2(4): 287-296 Mortality with No Excess Fluid Mortality rates with Excess Fluid
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 renal replacement therapy from a quality reporting standpointNo Nephrology consultation required to prescribe Aquadex FlexFlowFeatured sponsorship of CV usage discussion at Society of Thoracic Surgeons by Daniel Beckles, M.D., Ph.D. 1.Luciani GB, et al. Circulation. 2001 Sep 18;104(12 Suppl 1): I253-I259. 2. Kiziltepe, U, et al. Ann Thorac Surg. 2001 Feb;71(2): 684-93. 3. Grunenfelder et al. Eur J of Cardio-Thoracic surgery.2000; 17:77-83. 4. Sahoo TK, et al. Indian J Thorac Cardiovas Surg. 2007 Jun;23(2):116-124. 5. Boodhwani M et al. Eur J Cardiothorac Surg. 6. Torina et al. J of Thorac Cardiovasc Surg. 2012;144:663-70. 7. Papadppoulos et al. Perfusion. 2013;28:306-14. 10
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 membrane oxygenation (ECMO) therapy (6,000 procedures/yr)Solid organ transplantation (2,000 procedures/yr)ChronicHeart Disease (12,000 patients/yr) Q2 2019 510(k) filing with FDA for Pediatric Indication 11 2 1 3 4 5 https://www.ncbi.nlm.nih.gov/pubmed/23833312 https://www.cdc.gov/ncbddd/heartdefects/data.htmlhttps://www.ncbi.nlm.nih.gov/pubmed/23246046. https://www.organdonor.gov/about/donors/child-infant.html.http://www.heartviews.org/article.asp?issn=1995-705X;year=2016;volume=17;issue=3;spage=92;epage=99;aulast=Jayaprasad
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 study, a 3% increase in mortality was observed for every 1% increase in fluid overload (FO)1,2Children with more than 20% FO had an odds ratio for mortality of 8.5 compared with children with less than 20% FO.1,2Ultrafiltration may be considered as an alternative to diuretics and other CRRT modalities that can be less effective, less efficient or not well-tolerated.3-6 1. Sutherland SM, et al. American Journal of Kidney Diseases, vol. 55, no. 2, pp. 316-325, February 2010. 2. Gillespie RS, et al. Pediatric Nephrology, vol. 19, no. 12, pp. 1394-1399, December 2004. 3. Wang S, et al. Perfusion., vol. 27, no. 5, pp. 438-46, Sep 2012. 4. Askenazi D, et al. Pediatr Nephrol., vol. 31, no. 5, pp. 853-860, May 2016. 5. Chakravarti S, et al. Pediatr Rep., vol. 8, no. 2, p. 6596, 23 Jun 2016. 6. Raina R, et al. PLoS ONE, vol. 12, no. 5, p. e0178233, 30 May 2017. 12
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 OpportunityGoal is to manage HF patients proactively to avoid 30 day readmissions2 hospitals currently offering Aquadex FlexFlow therapy in an outpatient setting:Christ Hospital in CincinnatiMedstar Good Samaritan in Baltimore Significant Opportunity in Heart Failure For Outpatient Setting 13
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 with partners:Daxor Corporation: (NYSE: DXR) Daxor is providing clinically-proven blood volume analysisNIMedical, Inc.: NIMedical has developed new capabilities in using bio-impedence to assess fluid levels in humansAcQtrac System, acquired in mid-2018: designed to noninvasively provide real-time measurements of hemodynamic parameters in fluid overload We Are Evaluating New Predictive Diagnostic Tools 14
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 volumeLower 30-day mortality by over 82% and readmission by 56% in heart failure2 when care is individualized using BVA. 365-day mortality reduced by 86%Rapid, noninvasive technique gives results in under 60 minutes, inpatient bedside or outpatient settings CHF Solutions and Daxor expect to complete a clinical evaluation to demonstrate improved outcomes in the second half of 2019 If clinical evaluation successful, we expect to initiate a co-marketing arrangement in the second half of 20191. Strobeck JE, et al. ACC 2018;1105-104, Propensity-score control matching analysis was performed for 245 consecutive HF admissions to a community hospital (Sept 2007–Apr 2014, age 78±10 yrs, HFrEF 50%, Stage 4 CKD 30%). Total blood volume (TBV) and red blood cell volume (RBCV) were measured at admission by an I-131 labeled albumin indicator-dilution technique [Daxor BVA-100]. Decongestion strategy targeted TBV to 6%-8% above patient-specific norm. Anemia was corrected with iron, epoetin, and/or packed red blood cells. Controls derived from CMS data were matched 10:1 for demographics, comorbidity, and year of treatment. Our collaboration with Daxor Corporation 15
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 is Fluid Overload? 1. Lewis JL, et al. Volume Overload. Merck Manual (Professional Version). Nov 2016. 2. Holte K, et al. Br J of Anaesth. 2002 Oct; 89 (4) 622-32. 3. Morin JF, et al. World Journal of Cardio Surgery, 2011; 1, 18-23. 4. Pradeep A, et al. HSR Proceedings in Intensive Care and Cardiovascular Anesthesia 2010; 2: 287-296. 5. https://www.renalandurologynews.com/nkf-2012-general-news/fluid-overload-in-burn-patients-affects-survival/article/240978/. 16
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. Granado R, et al. Fluid Overload in the ICU: Evaluation and Manageement. BMC Nephrology (2016) 17:109 2. Stein A, et al. Critical Care. 2012;16:R99. 17
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 Update from Journal American Medical Association (JAMA):2 Decrease in heart failure related readmissions but increase in 30-day and 1 year mortality rates † 1. Readmissions Reduction Program (HRRP). Centers for Medicare & Medicaid Services website. Updated April 18, 2016. Accessed May 25, 2016. 2. Journal of the American Medical Association (JAMA), November 2017 18
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 using ultrafiltration versus diuretic therapy over 90 days2An Aquadex FlexFlow program reduces excess readmissions and reduces Medicare DRG penalties 1. Costanzo MR et al. J Am Coll Cardiol. 2007;49(6):675-683. 2. Costanzo MR, et al. Ultrafiltration vs. Diuretics for the Treatment of Fluid Overload in Patients with Heart Failure: A Hospital Cost Analysis. Value Health.
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 50% of HF patients are discharged from the hospital with residual excess fluid:2 Worsening heart failure with increased mortality after dischargeInsufficient symptom relief, such as persistent congestionIncrease in re-hospitalization ratesRisk of electrolyte imbalances (i.e. low magnesium and low potassium) 20
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 specialty trained in extracorporeal therapy53% reduction in the risk of HF rehospitalization than those treated solely with diuretics at 90 days3Fewer HF re-hospitalization days due to cardiovascular event4 Aquadex FlexFlow System: A Solution to this Unmet Clinical Need 1 Bart BA, et. al., Am Coll Cardiol., 2005;46:2043– 6. 2 Jaski BE et al. J Card Fail. 2003; 9(3):227-231. 3 Costanzo MR, et al. J Am Coll Cardiol. 2007 Feb 13; 49(6): 675-683. 4. Costanzo MR, et. al., J Am Coll Cardiol., 2005;46:2047–51. 21
Aquadex FlexFlow Product Overview Aquadex FlexFlow Console Dual Lumen venous catheter Blood Circuit Set 22
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, compared to national average of 5.9 daysReadmission rate from before aquapheresis down from 12% to 4% the year priorAverage of 5.7 liters removed per patient *Data presented at the National Teaching Institute & Critical Care Exposition (NTI) in Chicago, IL on May 5-8, 2008. Results may vary. 23
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 2003JCF EUPHORIA Single-center, prospective, single-arm 20 Early Ultrafiltration (UF) in diuretic resistance 2005JACC RAPID-HF1 Multi-center, prospective, RCT 40 20 UF/20 SC Early UF vs Diuretics 2005JACC UNLOAD1 Multi-center, prospective, RCT 200100 UF/100 SC UF vs SC 2007JACC CARRESS-HF1 Multi-center, prospective, RCT 18894 UF/94 SC UF vs SC patients with cardiorenal syndrome 2012NEJM AVOID-HF1 Multi-center, prospective, RCT 224110 UF/114 SC(810 planned) UF vs SC to evaluate readmissions 2016JACC:HF 1. Level of Evidence Grading Scale as Adapted from the Oxford Centre for Evidence-based Medicine (2009) 24
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 and chronic heart failure 2012: McMurray JJ, et al. Eur Heart J. 2012 Jul; 33(14): 1787 – 1847. 4 2012 Canadian Cardiovascular Society Heart Failure Management Guidelines Update: McKelvie RS, et al. Can J Cardiol. 2013 Feb; 29(2): 168 – 181. ACC/AHA – American College of Cardiology/ American Heart Association1 Ultrafiltration may be considered for patients with obvious volume overload to alleviate congestive symptoms and fluid weight, or with refractory congestion not responding to medical therapyHFSA - Heart Failure Society Of America2Ultrafiltration may be considered in lieu of diureticsESC / HFA - European Society of Cardiology and Heart Failure Association3Venovenous isolated ultrafiltration is sometimes used to remove fluid in patients with HF, although is usually reserved for those unresponsive or resistant to diureticsCCS - Canadian Cardiovascular Society4Patients with persistent congestion despite diuretic therapy, with or without impaired renal function, may, under experienced supervision, receive continuous venovenous ultrafiltration 25
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 in our Minneapolis, MN facility Expanding Commercial Distribution 26
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
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 (*) Convertible at $29.68 per share, anti-dilution rights to next offering priceConsists of 554,322 warrants exercisable at $29.68, expiring Nov 2019 and Nov 2024; 9,494 warrants exercisable at $63.0, expiring Nov 2024; and 35,477 warrants exercisable at a weighted average exercise price of $367.89, expiring Feb 2022-Feb 2025. No anti-dilution provision on the warrants. (*) no outstanding debt Cash: $5.5M as of December 31, 2018 28
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 studyCardiac Surgery: leveraging acute need and clinical and economic benefits to drive adoptionPediatrics: providing a solution to an underserved market and seeking label modificationUS commercial footprint and growing international distributor networkU.S-based direct sales force and clinical education support specialistsGrowing international distribution networkAnticipated milestonesTampa VA first patient enrollment in outpatient study – Q2 2019Pediatric label expansion: 2H 2019Therapy initiation in several hospital systems for CV Surgery and Heart Failure CHF Solutions Investment Considerations 29
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