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

Date : 08/06/2019 @ 12:00PM
Source : GlobeNewswire Inc.
Stock : CHF Solutions Inc (CHFS)
Quote : 0.72  0.0597 (9.04%) @ 9:23PM
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CHF Solutions, Inc. Announces 53 Percent Increase in Revenues for Second Quarter 2019 Over Previous Year and 38 Percent Incre...

CHF Solutions (NASDAQ:CHFS)
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6 Months : From May 2019 to Nov 2019

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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 endedJune 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 SUBSIDIARIESCondensed 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 outstanding2,328,320 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 SUBSIDIARIESCondensed 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 SUBSIDIARIESCondensed Consolidated Statements of Cash Flows(Unaudited and in thousands)

  Six months endedJune 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

 

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