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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): November 6, 2018

CHF Solutions, Inc.
(Exact name of registrant as specified in its charter)


Delaware
 001-35312
68-0533453
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

12988 Valley View Road
Eden Prairie, Minnesota  55344
(Address of principal executive offices) (Zip Code)

(952) 345-4200
(Registrant’s telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

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:


 ☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 2.02
Results of Operations and Financial Condition.

On November 6, 2018, CHF Solutions, Inc. (the "Company") issued a press release reporting its financial results for the quarter ended September 30, 2018. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 2.02 and shall not be deemed to be "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.

Item 9.01
Financial Statements and Exhibits.


(d)
Exhibits.

The following exhibit is filed as part of this report:

No.
  
Description
     
 
Press Release, dated November 6, 2018, reporting the Company’s financial results for the quarter ended September 30, 2018

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.

Date: November 6, 2018
CHF SOLUTIONS, INC.
       
 
By:
/s/ Claudia Drayton
  
 
Name:
Claudia Drayton
  
 
Title:
Chief Financial Officer
  


Exhibit 99.1


CHF Solutions, Inc. Announces 42% Revenue Growth for its Third Quarter and Provides Company Update

Eden Prairie, MN: November 6, 2018: CHF Solutions, Inc. (NASDAQ: CHFS) announced today its third quarter results for the period ended September 30, 2018.  Highlights include:


 •
Revenue for third quarter ended September 30, 2018 increased 42 percent compared to the same period in 2017, and 24 percent sequentially over the second quarter of 2018.


•
Announced expansion into the post-surgical cardiovascular market, an adjacent market opportunity with a significant unmet clinical need.


•
Continued international expansion and announced entrance into the markets in Germany and Thailand.


•
Continued path to identify complementary diagnostic technologies. Completed acquisition of AcQtrac™ impedance technology and announced collaboration agreements with NIMedical and Daxor Corporation to evaluate available, market-cleared diagnostic technologies.


•
Announced completion of all manufacturing transfer activities from Baxter.


•
Ended the quarter with $8.2 million of cash and equivalents and no debt.

“We have delivered double-digit year over year quarterly growth for six quarters in a row,” said John Erb, Chairman and CEO. “We continue to execute on our strategy and deliver results.”

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 Investor Relations | CHF Solutions, Inc. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID: 8283328. An audio archive of the webcast will be available following the call at Investor Relations | CHF Solutions, Inc.

About CHF Solutions

CHF Solutions, Inc. (NASDAQ:CHFS) is a medical device company focused on commercializing the Aquadex FlexFlow® system for aquapheresis therapy. 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 objective is to improve the quality of life for patients with heart failure and related conditions. CHF Solutions is a Delaware corporation headquartered in Minneapolis 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, the statement regarding the benefits from using the Aquadex FlexFlow, trends in our revenue, our expansion plan and our future growth and developments.  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 business 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 SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
 (Unaudited and in thousands, except per share amounts)

   
Three months ended
September 30,
    
Nine months ended
September 30,
  
   
2018
    
2017
    
2018
    
2017
  
Net sales
  
$
1,363
    
$
957
    
$
3,499
    
$
2,722
  
Costs and expenses:
                                
Cost of goods sold
    
915
      
782
      
2,686
      
1,912
  
Selling, general and administrative
    
3,713
      
2,671
      
11,489
      
7,478
  
Research and development
    
985
      
367
      
2,107
      
1,002
  
Total costs and expenses
    
5,613
      
3,820
      
16,282
      
10,392
  
Loss from operations
    
(4,250
)
    
(2,863
)
    
(12,783
)
    
(7,670
)
Other income (expense):
                                
Other income, net
    
10
      
17
      
10
      
28
  
Warrant valuation expense
    
-
      
-
      
-
      
(67
)
Change in fair value of warrant liability
    
-
      
4
      
-
      
1,470
  
Total other income
    
10
      
21
      
10
      
1,431
  
Loss before income taxes
    
(4,240
)
    
(2,842
)
    
(12,773
)
    
(6,239
)
Income tax expense, net
    
(1
)
    
(5
)
    
(3
)
    
(6
)
Net loss
  
$
(4,241
)
  
$
(2,847
)
  
$
(12,776
)
  
$
(6,245
)
                                 
Basic and diluted loss per share
  
$
(0.61
)
  
$
(4.55
)
  
$
(2.47
)
  
$
(25.36
)
                                 
Weighted average shares outstanding – basic and diluted
    
6,987
      
626
      
5,171
      
359
  
                                 
Other comprehensive loss:
                                
Foreign currency translation adjustments
  
$
(1
)
  
$
(1
)
  
$
(2
)
  
$
(7
)
Total comprehensive loss
  
$
(4,242
)
  
$
(2,848
)
  
$
(12,778
)
  
$
(6,252
)

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


  
September 30,
2018
(unaudited)
    
December
31, 2017
  
ASSETS
            
Current assets
            
Cash and cash equivalents
  
$
8,222
    
$
15,595
  
Accounts receivable
    
787
      
545
  
Inventory
    
1,948
      
1,588
  
Other current assets
    
240
      
136
  
Total current assets
    
11,197
      
17,864
  
Property, plant and equipment, net
    
573
      
570
  
Other assets
    
21
      
21
  
TOTAL ASSETS
  
$
11,791
    
$
18,455
  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
                
Current liabilities
                
Accounts payable and accrued expenses
  
$
617
    
$
862
  
Accrued compensation
    
1,315
      
1,021
  
Other current liabilities
    
80
      
208
  
Total current liabilities
    
2,012
      
2,091
  
Other liabilities
    
126
      
126
  
Total liabilities
    
2,138
      
2,217
  
                 
Commitments and contingencies
    
—
      
—
  
                 
Stockholders’ equity
                
Series A junior participating preferred stock as of September 30, 2018 and December 31, 2017, par value $0.0001 per share; authorized 30,000 shares, none outstanding
    
—
      
—
  
Series F convertible preferred stock as of September 30, 2018 and December 31, 2017, par value $0.0001 per share; authorized 565 and 3,780 shares, respectively, issued and outstanding 565 and 3,780, respectively
    
—
      
—
  
Preferred stock as of September 30, 2018 and December 31, 2017, par value $0.0001 per share; authorized 39,969,435 and 39,966,220 shares, none outstanding
    
—
      
—
  
Common stock as of September 30, 2018 and December 31, 2017, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 7,074,407 and 3,798,929, respectively
    
1
      
—
  
Additional paid‑in capital
    
203,559
      
197,367
  
Accumulated other comprehensive income:
                
Foreign currency translation adjustment
    
1,225
      
1,227
  
Accumulated deficit
    
(195,132
)
    
(182,356
)
Total stockholders’ equity
    
9,653
      
16,238
  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  
$
11,791
    
$
18,455
  

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


  
Nine months ended
September 30,
  
   
2018
    
2017
  
Operating Activities:
            
Net loss
  
$
(12,776
)
  
$
(6,245
)
Adjustments to reconcile net loss to cash flows used in operating activities:
                
Depreciation and amortization expense
    
174
      
656
  
Stock-based compensation expense
    
1,544
      
391
  
Change in fair value of warrant liability
    
-
      
(1,470
)
Warrant valuation expense
    
-
      
67
  
Changes in operating assets and liabilities:
                
Accounts receivable
    
(242
)
    
(498
)
Inventory
    
(361
)
    
(660
)
Other current and long-term assets
    
(104
)
    
28
  
Accounts payable and accrued expenses
    
(78
)
    
(1,038
)
Net cash used in operations
    
(11,843
)
    
(8,769
)
                 
Investing Activities:
                
Purchases of property and equipment
    
(177
)
    
(206
)
Net cash used in investing activities
    
(177
)
    
(206
)
                 
Financing Activities:
                
Net proceeds from public stock offering
    
4,649
      
8,002
  
Net proceeds from exercise of warrants
    
-
      
1,981
  
Net proceeds from the sale of common stock, preferred stock, and warrants
    
-
      
184
  
Net cash provided by financing activities
    
4,649
      
10,167
  
                 
Effect of exchange rate changes on cash
    
(2
)
    
(2
)
Net increase (decrease) in cash and cash equivalents
    
(7,373
)
    
1,190
  
Cash and cash equivalents - beginning of period
    
15,595
      
1,323
  
Cash and cash equivalents - end of period
  
$
8,222
    
$
2,513
  
                 
Supplement schedule of non-cash activities
                
Warrants issued as inducement to warrant exercise
  
$
-
    
$
509
  
Conversion of temporary equity to permanent equity
  
$
-
    
$
485
  
                 
Supplemental cash flow information
                
Cash paid for income taxes
  
$
-
    
$
8
  

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