Loading, Please Wait...

CST: 11/12/2019 06:01:53   

CHF Solutions, Inc. Announces 53 Percent Increase in Revenues for Second Quarter 2019 Over Previous Year and 38 Percent Increase from Q1 2019

126 Days ago

EDEN PRAIRIE, Minn., Aug. 06, 2019 (GLOBE NEWSWIRE) -- CHF Solutions, Inc. (Nasdaq: CHFS), a medical device company focused on developing, manufacturing and commercializing a clinically proven alternative to diuretics for the treatment of fluid overload,  announced today its results for the second quarter ended June 30, 2019, which included the following highlights:

  • Revenue for second quarter ended June 30, 2019 was $1.7 million, an increase of 53 percent compared to the same period of the prior year, and 38% sequentially from Q1 2019. Gross margin percentages increased to 50 percent from 21 percent during the same period a year ago, after transition to in-house manufactured inventory.

  • Opened 7 new hospitals and hospital systems. In Q3 expect to open more than 10 new accounts including several new hospital systems.

  • Increased field education specialists from 5 to 14 to support new account launches and rapid growth.

  • Continued progress towards obtaining regulatory clearance for an expanded label in pediatrics. Pre-submission meeting with the FDA held in May 2019; submission expected in Q3 2019 and clearance in Q4 2019.

  • Working with a large hospital system in New York on a 700 patient retrospective study to evaluate the clinical impact of utilizing the Aquadex FlexFlow® system on post-surgery patients, and with a large hospital in Philadelphia on a 344 patient retrospective study to evaluate the impact of ultrafiltration on fluid removal, renal outcomes, and readmission rates.

“We continue to deliver impressive double-digit increase in our revenue, and we believe we are well-poised to continue to grow in the quarters to come,” said John Erb, chairman and CEO of CHF Solutions. “We will continue to develop and refine our strategic focus toward driving revenue, which is the key metric our employees, shareholders and potential investors use to measure performance.”

FINANCIALS

CHF SOLUTIONS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss
 (Unaudited and in thousands, except per share amounts)

 

 
  Three months ended
June 30,
Six months ended
June 30,
    2019   2018       2019 2018  
Net sales $ 1,677   $ 1,099   $ 2,892   $ 2,136  
Costs and expenses:                        
  Cost of goods sold   835     870     1,447     1,771  
  Selling, general and administrative   3,973     3,765     7,991     7,776  
  Research and development   1,297     643     2,607       1,122  
  Total costs and expenses   6,105     5,278     12,045     10,669  
  Loss from operations   (4,428 )   (4,179 )   (9,153 )   (8,533 )
  Loss before income taxes   (4,428 )   (4,179 )   (9,153 )   (8,533 )
  Income tax expense   (2 )   (2 )   (4 )   (2 )
Net loss $ (4,430 ) $ (4,181 ) $ (9,157 ) $ (8,535 )
                         
Basic and diluted loss per share $ (1.93 ) $ (13.03 ) $ (8.82 ) $ (28.03 )
                         
Weighted average shares outstanding – basic and diluted   2,295     321     1,550     304  
                         
Other comprehensive loss:                        
  Foreign currency translation adjustments $ (3 ) $ (2 ) $ (5 ) $ (1 )
Total comprehensive loss $ (4,433 ) $ (4,183 ) $ (9,162 ) $ (8,536 )


CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)

    June 30,
2019
    December 31,
2018
 
ASSETS   (unaudited)        
Current assets            
  Cash and cash equivalents   $ 7,402   $ 5,480  
  Accounts receivable   932     786  
  Inventory   1,690     1,658  
  Other current assets   278     203  
Total current assets   10,302     8,127  
  Property, plant and equipment, net   574     536  
  Operating lease right-of-use asset   531      
  Other assets   21     113  
TOTAL ASSETS $ 11,428   $ 8,776  
             
LIABILITIES AND STOCKHOLDERS’ EQUITY            
Current liabilities            
  Accounts payable $ 1,178   $ 1,133  
  Accrued compensation   1,186     1,498  
  Current portion of operating lease liability   176      
  Other current liabilities   97     209  
Total current liabilities   2,637     2,840  
  Operating lease liability   357     -  
Total liabilities   2,994     2,840  
             
Commitments and contingencies     —       —  
             
Stockholders’ equity            
Series A junior participating preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 30,000 shares, none outstanding     —       —  
Series F convertible preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 535 and 535 shares, respectively, issued and outstanding 535 and 535, respectively     —       —  
Series G convertible preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 550,842 and 0 shares, respectively, issued and outstanding 550,842 and 0, respectively            
Preferred stock as of June 30, 2019 and December 31, 2018, par value
$0.0001 per share; authorized 39,418,623 and 39,969,465 shares, none outstanding
    —       —  
Common stock as of June 30, 2019 and December 31, 2018, par value
$0.0001 per share; authorized 100,000,000 shares, issued and outstanding
2,328,320 and 513,445, respectively
    —       —  
Additional paid‑in capital   215,761     204,101  
Accumulated other comprehensive income:            
  Foreign currency translation adjustment   1,218     1,223  
Accumulated deficit   (208,545 )   (199,388 )
Total stockholders’ equity   8,434     5,936  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 11,428   $ 8,776  


CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited, In thousands, except share amounts)

    Outstanding
Shares of Common Stock
  Common
Stock
  Additional
Paid in
Capital
  Accumulated
Other

Comprehensive
Income
  Accumulated
Deficit
  Stockholders’
Equity
 
Balance December 31, 2017   271,357   $   $ 197,367   $ 1,227   $ (182,356 ) $ 16,238  
Net loss            (4,354 ) (4,354 )
Foreign currency translation adjustment          1     1  
Stock-based compensation and stock awards, net    3     501       501  
Conversion of preferred stock into common stock   32,365            
Balance March 31, 2018   303,725   $   $ 197,868   $ 1,228   $ (186,710 ) $ 12,386  
Net loss                    (4,181 )   (4,181 )
Foreign currency translation adjustment               (2 )       (2 )
Stock-based compensation, net    3         606             606  
Conversion of preferred stock into common stock   18,127                      
Balance June 30, 2018   321,855   $   $ 198,474   $ 1,226   $ (190,891 ) $ 8,809  
                                     
    Outstanding
Shares of Common Stock
  Common
Stock
  Additional
Paid in
Capital
  Accumulated
Other

Comprehensive
Income
  Accumulated
Deficit
  Stockholders’
Equity
 
Balance December 31, 2018   513,445   $   $ 204,101   $ 1,223   $ (199,388 ) $ 5,936  
Net loss            (4,727 ) (4,727 )
Foreign currency translation adjustment          (2 )   (2 )
Stock-based compensation, net    3     362       362  
Issuance of common and preferred stock, net   455,178     10,959       10,959  
Conversion of preferred stock into common stock   1,100,394            
Balance March 31, 2019   2,069,020   $   $ 215,422   $ 1,221   $ (204,115 ) $ 12,528  
Net loss            (4,430 ) (4,430 )
Foreign currency translation adjustment          (3 )   (3 )
Stock-based compensation, net        339       339  
Conversion of preferred stock into common stock   259,300            
Balance June 30, 2019   2,328,320   $   $ 215,761   $ 1,218   $ (208,545 ) $ 8,434  


CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited and in thousands)

    Six months ended
June 30,
    2019     2018  
Operating Activities:            
Net loss $ (9,157 ) $ (8,535 )
Adjustments to reconcile net loss to cash flows used in operating activities:            
  Depreciation and amortization   120     115  
  Stock-based compensation expense, net   701     1,107  
Changes in operating assets and liabilities:            
  Accounts receivable   (146 )   (107 )
  Inventory   (32 )   (727 )
  Other current assets   (75 )   (48  
  Other assets and liabilities   (18 )    
  Accounts payable and accrued expenses   (267 )   (283 )
Net cash used in operating activities   (8,874 )   (8,478 )
             
Investing Activities:            
  Purchases of property and equipment   (158 )   (121 )
Net cash used in investing activities   (158 )   (121 )
             
Financing Activities:            
  Net proceeds from public stock offering, net   10,959      
Net cash provided by financing activities   10,959      
             
Effect of exchange rate changes on cash   (5 )   (1 )
Net increase (decrease) in cash and cash equivalents   1,922     (8,600 )
Cash and cash equivalents - beginning of period   5,480     15,595  
Cash and cash equivalents - end of period $ 7,402   $ 6,995  
             

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 the Investors page of the CHF Solutions website at http://ir.chf-solutions.com or access the webcast directly at 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: 6292209  An audio archive of the webcast will be available following the call on the Investor page at http://ir.chf-solutions.com/events.

About CHF Solutions

CHF Solutions, Inc. (NASDAQ:CHFS) is a medical device company focused on developing, manufacturing and commercializing the Aquadex FlexFlow system for aquapheresis therapy. The Aquadex FlexFlow system is a clinically proven therapy that provides a safe, effective and predictable method of removing excess sodium and fluid from patients suffering from fluid overload. The Aquadex FlexFlow system is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. The company's vision is to change the lives of fluid overloaded patients through science, collaboration, and innovative medical technology. 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.

Forward-Looking Statements

Certain 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 Company’s ability to grow revenue and add new accounts in future quarters and the timing of the regulatory clearance for an expanded label in pediatrics. 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.

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

MEDIA
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

 

Is your business listed correctly on America’s largest city directory network of 1,000 portals?