CHF Solutions, Inc. (Nasdaq: CHFS) announced today its results for the fourth quarter and year ended December 31, 2019, which included the following highlights:

  • Received 510(k) clearance in the U.S. and CE Mark in the EU for adult and pediatric patients who weigh 20 kg or more and for the next generation Aquadex console, which will be sold as Aquadex SmartFlow™.  
  • Announced expansion of commercial presence in Europe with distribution arrangement for Germany, Austria and Switzerland.
  • Announced presentation of clinical data from an investigator-initiated analysis at the American Society of Kidney Week highlighting the efficacy and simplicity of use of Aquadex FlexFlow in treating patients in critical care settings such as cardiogenic shock, anasarca, ATN with fluid overload, ESRD with bridge ultrafiltration between hemodialysis treatment, and post-operative fluid overload.
  • Completed sales force realignment to increase focus on cardiac surgery and eventually pediatrics. Revenue for fourth quarter ended December 31, 2019 was $1.4 million, a decrease of 8.8 percent from Q4 2018. For the year 2019, revenue totaled $5.5 million, a 10 percent increase from 2018.  
  • Ended the year with $1.3 million in cash and no debt. Subsequent to quarter end, announced the closing of an underwritten public offering for net proceeds of approximately $8.6 million, for total proforma cash balance of $9.9 million.

“I look back at 2019 as a very successful year for the company,” said John Erb, chairman and CEO of CHF Solutions. “We made important strides in our commercialization efforts, including focusing on new market opportunities and driving important product improvements which we believe will deliver additional growth in 2020 and beyond.”

The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on the Company’s performance. To access the live webcast, please visit http://ir.chf-solutions.com/events. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID: 7489468. An audio archive of the webcast will be available following the call at http://ir.chf-solutions.com/events..

About CHF Solutions

CHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and innovation.  The company is focused on developing, manufacturing, and commercializing the Aquadex SmartFlow system for ultrafiltration therapy. CHF Solutions is a Delaware corporation headquartered in Minneapolis, Minnesota with wholly owned subsidiaries in Australia and Ireland.  The company has been listed on the Nasdaq Capital Market since February 2012.

About the Aquadex SmartFlow System The Aquadex SmartFlow system is a clinically proven therapy that provide a safe, effective, and predictable method of removing excess fluid from patients suffering from fluid overload. The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.  All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.

Forward-Looking StatementsCertain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2020 and beyond.  Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.  Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, 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 ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC.  Forward-looking statements speak only as of the date when made.  CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

FINANCIALS

CHF SOLUTIONS, INC. AND SUBSIDIARIESConsolidated Statements of Operations and Comprehensive Loss(in thousands, except per share amounts)

  Three months ended December 31Year endedDecember 31,
  2019 2018    20192018 
Net sales$1,367 $1,499 $5,511 $4,998 
Costs and Expenses:            
Cost of goods sold 673  984  2,660  3,670 
Selling, general and administrative 4,187  3,822  16,285  15,311 
Research and development 953  946  4,672  3,053 
Total costs and expenses 5,813  5,752  23,617  22,034 
Loss from operations (4,446) (4,253) (18,106) (17,036)
Other income, net 1      10 
Loss before income taxes (4,445) (4,253) (18,106) (17,026)
Income tax expense (3) (3) (8) (6)
Net loss$(4,448)$(4,256)$(18,114)$(17,032)
             
Basic and diluted loss per share$(1.12)$(8.37)$(9.30)$(42.14)
             
Weighted average shares outstanding – basic and diluted 3,988  509  2,433  404 
             
Other comprehensive loss:            
Foreign currency translation adjustment$(5)$(2)$(9)$(4)
Total comprehensive loss$(4,453)$(4,258)$(18,123)$(17,036)
             
             

CHF SOLUTIONS, INC. AND SUBSIDIARIESConsolidated Balance Sheets(in thousands, except share and per share amounts)

  December 31,2019  December 31, 2018 
ASSETS      
Current assets      
Cash and cash equivalents$1,279 $5,480 
Accounts receivable 799  786 
Inventories 1,797  1,658 
Other current assets 161  203 
Total current assets 4,036  8,127 
Property, plant and equipment, net 991  536 
Operating lease right-of-use asset, net 442   
Other assets 133  113 
TOTAL ASSETS$5,602 $8,776 
       
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities      
Accounts payable$1,488 $1,133 
Accrued compensation 1,592  1,498 
Current portion of operating lease liability 186   
Other current liabilities 85  209 
Total current liabilities 3,351  2,840 
Operating lease liability 261   
Total liabilities 3,612  2,840 
Commitments and contingencies      
       
Stockholders’ equity      
Series A junior participating preferred stock as of December 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 30,000 shares, none outstanding    
Series F convertible preferred stock as of both December 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 535 shares, issued and outstanding 535 shares    
Preferred stock as of both December 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 39,969,465 shares, none outstanding    
Common stock as of December 31, 2019 and December 31, 2018, par value$0.0001 per share; authorized 100,000,000 shares, issued and outstanding4,674,068 and 513,445, respectively    
Additional paid‑in capital 218,278  204,101 
Accumulated other comprehensive income:      
Foreign currency translation adjustment 1,214  1,223 
Accumulated deficit (217,502) (199,388)
Total stockholders’ equity 1,990  5,936 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY$5,602 $8,776 
       
       

CHF SOLUTIONS, INC. AND SUBSIDIARIESConsolidated Statements of Cash Flows(in thousands)

     For the years ended December 31,  
  2019  2018 
 Operating Activities      
Net loss $(18,114) $(17,032)
Adjustments to reconcile net loss to cash flows from operating activities:      
Depreciation and amortization 239  232 
Stock-based compensation expense 1,512  2,087 
Changes in operating assets and liabilities:      
Accounts receivable (13) (241)
Inventories (343) (70)
Other current assets 42  (67)
Other assets and liabilities 18  (14)
Accounts payable and accrued expenses 292  545 
Net cash used in operations (16,367) (14,560)
       
Investing activities:      
Purchase of property and equipment (490) (198)
Net cash used in investing activities (490) (198)
       
Financing activities:      
Net proceeds from public stock offerings, net 12,665  4,647 
Net cash provided by financing activities 12,665  4,647 
       
Effect of exchange rate changes on cash (9) (4)
Net decrease in cash and cash equivalents (4,201) (10,115)
Cash and cash equivalents—beginning of year 5,480  15,595 
Cash and cash equivalents—end of year $1,279  $5,480 
       
Supplemental schedule of non-cash activities      
Financing fees incurred for subsequent equity financing included in other assets and accounts payable $111  $78 
Inventory transferred to property, plant and equipment $204  $ 
         
Supplemental cash flow information        
Cash paid for income taxes $4  $2 
         

CONTACTS:

INVESTORS:
Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.
952-345-4205
ir@chf-solutions.com

-or-
Bret Shapiro
Managing Partner
CORE IR
516-222-2560
brets@coreir.com
www.coreir.com

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