UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 24, 2019
CHF Solutions, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-35312
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No. 68-0533453
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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12988 Valley View Road, Eden Prairie, MN 55344
(Address of Principal Executive Offices) (Zip Code)
(952) 345-4200
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share
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CHFS
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Nasdaq Capital Market
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD Disclosure
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CHF Solutions, Inc. (the “Company”) previously
announced that Claudia Drayton, its Chief Financial Officer, will present at the Ladenburg Thalmann 2019 Healthcare Conference on September 24, 2019 at 4:00 p.m. Eastern Time. This Form 8-K is being furnished to the SEC to furnish the presentation
materials attached as Exhibit 99.1 hereto.
In accordance with General Instruction B.2. to Form 8-K, this information, including Exhibit 99.1, is furnished pursuant to Item 7.01 and shall not be
deemed as “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information on this Current Report on Form 8-K will not be deemed as an admission as to
the materiality of any information that is required to be disclosed solely by Regulation FD.
| Item 9.01 |
Financial Statements and Exhibits.
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Exhibit No.
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Description
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99.1
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Presentation by Claudia Drayton, Chief Financial Officer of CHF Solutions, Inc.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Date: September 24, 2019
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CHF SOLUTIONS, INC.
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By:
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/s/ Claudia Drayton
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Name:
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Claudia Drayton
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Title:
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Chief Financial Officer
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EXHIBIT INDEX
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Exhibit No.
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Description
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Presentation by Claudia Drayton, Chief Financial Officer of CHF Solutions, Inc.
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Exhibit 99.1
Corporate Presentation (NASDAQ: CHFS)September 24, 2019 For Investor Purposes Only: Not For Product
Promotion
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 to be covered by the Private
Securities Litigation Reform Act of 1995. Except for statements of historical fact, all forward‐looking statements are management’s present expectations and are not guarantees of future events and are subject to a number of known and unknown
risks and uncertainties and other factors that may cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. In some cases, you can identify forward-looking statements by terminology
such as “may,” “will,” “could,” “would,” “should,” “plan,” “predict,” “potential,” “project,” “promising,” “expect,” “estimate,” “anticipate,” “intend,” “goal,” “strategy,” “milestone,” and similar expressions and variations thereof. 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, our business strategy, market size, potential growth opportunities 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 we undertake no obligation 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.The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement
of such products. 2 Safe Harbor Statement Aquadex FlexFlow is a registered trademark of CHF Solutions, Inc
3 Financial Highlights
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% 42%
80% 2019 17% 58% Gross Margins $ in 000s
Our Vision 5 We Are Dedicated To Changing The Lives Of Patients Suffering from Fluid Overload
Through Science, Collaboration, And Innovation
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 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/. 6
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. 7
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 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) 8
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 HFSA - Heart Failure Society Of America2ESC / HFA - European Society of Cardiology and Heart Failure Association3CCS - Canadian Cardiovascular Society4 9
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. 10
Aquadex FlexFlow Product Overview Aquadex FlexFlow Console Dual Lumen venous catheter Blood
Circuit Set 11
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, Disease)DialysisSepsisAdult
EMCO*strategic entry point Heart FailureInpatientOutpatient PediatricRenal ReplacementHeart DiseaseCardiac SurgeryTransplantsECMO $950M $900M $115M 1. Claur-Del Granado R, Mehta M. BMC Nephrology. 2016;109(17):1AB Target Segments
& Addressable Opportunity (US) . 12
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. 40% of patients cannot eliminate excess
fluids post surgery due to Acute Kidney Injury1Efficient removal can save ICU time and avoid adverse events 1. Ann Thorac Surg. 2011; 92-1539-47). 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 CV Surgery
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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/. 2. Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. 3. Testani JM, et al. Circ Heart Failure. 2016;9(1). HF
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 50% mortality rate. No alternative
solutions for premature babies.Historically an underserved marketExpect FDA label expansion in pediatrics late Q4 2019 1. See slide 23 for references. Pediatrics
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 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 Survival rates with No Excess Fluid Survival rates with Excess Fluid 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 required to prescribe Aquadex
FlexFlow 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. 17 CV Surgery
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 admission – the average length of stay is
6-days, while DRG payments only cover up to 4-days. Diuretics are the current standard of care.Hospital administrations are actively pursuing projects and processes to reduce the growing economic burden of heart failure. 1. Heidenreich PA,
Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart AssociationExternal. Circulation. 2011;123(8):933–44.2.
Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19)2428-2445 CONFIDENTIAL - FOR INTERNAL USE ONLY - DO NOT DISTRIBUTE ©2019 CHF Solutions, Inc. HF $30.7 Billionin health care services, medications to treat heart failure, & missed
days of work HF Costs to US Healthcare System1
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 excess 30-day readmissionsPenalty #1:
No additional DRG payment for patients readmitted to the hospital within 30-days of initial dischargePenalty #2: hospitals can lose ≤3% of Medicare reimbursement on all admissions † 1. Readmissions Reduction Program (HRRP). Centers for
Medicare & Medicaid Services website. Updated April 18, 2016. Accessed May 25, 2016. 19 HF 24%within 30 days 50% within 6 months Heart Failure Readmission Rates (US)2
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 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. HF
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. 21 HF
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 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 22 HF
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 (12,000 patients/yr)
5 23 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 Aquadex FlexFlow/ultrafiltration is currently being prescribed by
physicians to treat various pediatric conditions: Q3 2019 510(k) filing with FDA for Pediatric indication- Label expansion for pediatrics >20kg expected approximately 90 days post submission Pediatrics
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 24
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 in our Minneapolis, MN facility Expanding
Commercial Distribution 25
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 intensive care unit (ICU) settings such
as burn, trauma and sepsisWorldwide opportunity is 3x US market size 26 CHF Growth Metrics
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 – Q4 2019Pediatric label expansion: Q4 2019Therapy initiation in several hospital
systems for CV Surgery and Heart Failure CHF Solutions Investment Considerations 27
Thank you