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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):  August 4, 2020

CHF Solutions, Inc.
(Exact Name of Registrant as Specified in its Charter)

Delaware
001-35312
No. 68-0533453
(State or Other Jurisdiction of
Incorporation or Organization)
(Commission File Number)
(I.R.S. Employer
Identification No.)

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:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
CHFS
Nasdaq Capital Market

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 August 4, 2020, CHF Solutions, Inc. (the “Company”) issued a press release reporting its financial results for the period ended June 30, 2020. 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

Exhibit No.
Description

Press Release, dated August 4, 2020, reporting the financial results of CHF Solutions, Inc. for the period ended June 30, 2020

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: August 4, 2020
CHF SOLUTIONS, INC.
     
 
By:
/s/ Claudia Drayton
 
Name:
Claudia Drayton
 
Title:
Chief Financial Officer

Exhibit 99.1

CHF Solutions, Inc. Announces 14 Percent Increase in Revenue for Second
Quarter 2020 Over Previous Quarter and Provides Company Update

Eden Prairie, MN: August 4, 2020: (GLOBE NEWSWIRE) CHF Solutions, Inc. (Nasdaq: CHFS) announced today its results for the second quarter ended June 30, 2020, which included the following highlights:


 •
Revenue for the second quarter ended June 30, 2020, was $1.9 million, an increase of 14 percent from the first quarter of 2020 and 11 percent compared to the same period of the prior year.

•
Hosted two physician-led webinars on treatment of critically ill, COVID-19 patients, including a discussion of the publication SARS-CoV-2 (COVID-19) and intravascular volume management strategies in the critically ill.1 which addressed the role of ultrafiltration in the treatment of COVID-19 patients.

•
Hosted a webinar led by Dr. David Askenazi, M.D. MSPH on treatment of fluid overload on pediatric patients. Announced partnership for a pediatric registry.

•
Announced the signing of a new a distribution arrangement to sell in the United Arab Emirates, effectively initiating presence in the Middle East.

•
Submitted a patent application for an adaptation of Aquadex SmartFlow™ system to rapidly clear cytokines.

•
Initiated a distribution agreement with Renal Sense, Ltd. to market and sell complementary real-time monitoring of patient’s renal function to prevent acute kidney injury.

•
Ended the quarter with $7.8 million in cash and no debt. During the quarter, closed on two registered direct offering for next proceeds of $3.4 million, and received $2.1 million from warrant exercises.

“We continue to be very pleased that we produce a product that is providing a meaningful therapy for treating the COVID-19 patients,” said John Erb, chairman and CEO of CHF Solutions. “We know we are very fortunate to be less impacted than many small medical device companies, and although the rest of the year is full of uncertainty, we remain optimistic about the value we can bring to our customers and our investors.”

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: 3591247. 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 headquartered in Minneapolis, Minn., 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 delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (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 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

1.
https://pubmed.ncbi.nlm.nih.gov/32336959/
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 value that the company brings to its customers.  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 impact of the COVID-19 pandemic,  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, in thousands, except per share amounts)

   
Three months ended
June 30,
Six months ended
June 30,
  
   
2020
  
2019
    
2020
  
2019
  
Net sales
$
1,863
  
$
1,677
  
$
3,493
  
$
2,892
  
Costs and expenses:
                        
     Cost of goods sold
  
664
    
835
    
1,460
    
1,447
  
     Selling, general and administrative
  
4,234
    
3,973
    
8,770
    
7,991
  
     Research and development
  
885
    
1,297
    
1,749
    
    2,607
  
        Total costs and expenses
  
5,783
    
6,105
    
11,979
    
12,045
  
         Loss from operations
  
(3,920
)
  
(4,428
)
  
(8,486
)
  
(9,153
)
         Loss before income taxes
  
(3,920
)
  
(4,428
)
  
(8,486
)
  
(9,153
)
     Income tax expense
  
(2
)
  
(2
)
  
(4
)
  
(4
)
Net loss
$
(3,922
)
$
(4,430
)
$
(8,490
)
$
(9,157
)
                         
Basic and diluted loss per share
$
(0.10
)
$
(1.93
)
$
(0.37
)
$
(8.82
)
                         
Weighted average shares outstanding – basic and diluted
  
37,923
    
2,295
    
27,181
    
1,550
  
                         
Other comprehensive loss:
                        
     Foreign currency translation adjustments
$
(2
)
$
(3
)
$
(5
)
$
(5
)
Total comprehensive loss
$
(3,924
)
$
(4,433
)
$
(8,495
)
$
(9,162
)

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

   
June 30,
2020
    
December
31, 2019
  
ASSETS
  
(unaudited)
        
Current assets
            
        Cash and cash equivalents
$
7,821
  
$
1,279
  
        Accounts receivable
  
978
    
799
  
        Inventory
  
2,789
    
1,797
  
        Other current assets
  
141
    
161
  
Total current assets
  
11,729
    
4,036
  
        Property, plant and equipment, net
  
1,042
    
991
  
        Operating lease right-of-use asset
  
351
    
442
  
        Other assets
  
21
    
133
  
TOTAL ASSETS
$
13,143
  
$
5,602
  
             
LIABILITIES AND STOCKHOLDERS’ EQUITY
            
Current liabilities
            
          Accounts payable
$
1,387
  
$
1,488
  
          Accrued compensation
  
1,695
    
1,592
  
          Current portion of operating lease liability
  
196
    
186
  
          Current portion of finance lease liability
  
17
    
—
  
          Other current liabilities
  
40
    
85
  
Total current liabilities
  
3,335
    
3,351
  
          Operating lease liability
  
160
    
261
  
          Finance lease liability
  
46
    
               —
  
Total liabilities
  
3,541
    
3,612
  
             
Commitments and contingencies
            
             
Stockholders’ equity
            
Series A junior participating preferred stock as of June 30, 2020 and
December 31, 2019, par value $0.0001 per share; authorized 30,000 shares, none outstanding
  
                  —
    
              —
  
Series F convertible preferred stock as of June 30, 2020 and December 31, 2019, par value $0.0001 per share; authorized 435 and 535 shares, respectively, issued and outstanding 435 and 535, respectively
  
                 —
    
              —
  
Preferred stock as of June 30, 2020 and December 31, 2019, par value
$0.0001 per share; authorized 39,969,565 and 39,969,465 shares, none outstanding
  
                 —
    
               —
  
Common stock as of June 30, 2020 and December 31, 2019, par value
$0.0001 per share; authorized 100,000,000 shares, issued and outstanding
43,196,813 and 4,674,068, respectively
  
                                  4
    
                —
  
Additional paid‑in capital
  
234,381
    
218,278
  
Accumulated other comprehensive income:
            
     Foreign currency translation adjustment
  
1,209
    
1,214
  
Accumulated deficit
  
(225,992
)
  
(217,502
)
Total stockholders’ equity
  
9,602
    
1,990
  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
13,143
  
$
5,602
  

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

   
Six months ended
June 30,
  
   
2020
    
2019
    
Operating Activities:
              
Net loss
$
(8,490
)
$
(9,157
)
Adjustments to reconcile net loss to cash flows used in operating activities:
            
     Depreciation and amortization
  
151
    
120
  
      Stock-based compensation expense, net
  
727
    
701
  
      Loss on disposal of property and equipment
  
46
    
—
  
Changes in operating assets and liabilities:
            
     Accounts receivable
  
(179
)
  
(146
)
     Inventory
  
(1,104
)
  
(32
)
     Other current assets
  
20
    
(75
)
     Other assets and liabilities
  
112
    
(18
)
     Accounts payable and accrued expenses
  
(43
)
  
(267
)
Net cash used in operating activities
  
(8,760
)
  
(8,874
)
             
Investing Activities:
            
    Purchases of property and equipment
  
(69
)
  
(158
)
Net cash used in investing activities
  
(69
)
  
(158
)
             
Financing Activities:
            
    Proceeds from public stock offerings, net
  
13,040
    
10,959
  
    Proceeds from warrant exercises
  
2,340
    
—
  
    Payments on finance lease liability
  
(4
)
  
—
  
Net cash provided by financing activities
  
15,376
    
10,959
  
             
Effect of exchange rate changes on cash
  
(5
)
  
(5
)
Net increase in cash and cash equivalents
  
6,542
    
1,922
  
Cash and cash equivalents - beginning of period
  
1,279
    
5,480
  
Cash and cash equivalents - end of period
$
7,821
  
$
7,402
  
             
Supplemental cash flow information
            
   Cash paid for income taxes
$
—
  
$
—
  
   Inventory transferred to property, plant and equipment
$
112
  
$
—
  
   Equipment acquired through finance lease liability
$
67
  
$
          —
  


CONTACTS:

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

MEDIA:
Jessica Stebing
Health+Commerce
260-336-6202
jstebing@healthandcommerce.com