UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549

FORM 10‑Q


QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended SeptemberJune 30, 20192020
OR


TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to __________


Commission file number 001-35312



CHF SOLUTIONS, INC.
(Exact Name of Registrant as Specified in its Charter)

Delaware
No. 68-0533453
(State or Other Jurisdiction of Incorporation or Organization)
(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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.0001 per shareCHFSNasdaq Capital Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒  No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required
to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.  See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.Act:

Large accelerated filer ☐

Accelerated filer ☐
Non-accelerated filer ☒

Smaller reporting company ☒
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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐  No ☒

The number of outstanding shares of the registrant’s common stock, $0.0001 par value, as of November 4, 2019August 3, 2020 was 3,454,992.45,102,231



TABLE OF CONTENTS

Page Number
 Page Number
PART I—FINANCIAL INFORMATION
 
  
Item 13
 3
 4
 5
 6
 7
Item 21513
Item 321
Item 421
   
PART II—OTHER INFORMATION
 
Item 122
Item 1A22
Item 222
Item 322
Item 422
Item 522
Item 622

2

PART I—FINANCIAL INFORMATION
ITEM 1.FINANCIAL STATEMENTS
FINANCIAL STATEMENTS
CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)

 
September 30,
2019
 
December 31,
2018
  
June 30,
2020
  
December 31,
2019
 
ASSETS (unaudited)    (unaudited)    
Current assets           
Cash and cash equivalents 
$
3,634
  
$
5,480
  $7,821  $1,279 
Accounts receivable  
528
   
786
  978  799 
Inventory  
1,612
   
1,658
  2,789  1,797 
Other current assets  
277
   
203
   141   161 
Total current assets  6,051   8,127  11,729  4,036 
Property, plant and equipment, net  
1,025
   
536
  1,042  991 
Operating lease right-of-use asset, net  
487
   
 
Operating lease right-of-use asset 351  442 
Other assets  
21
   
113
   21   133 
TOTAL ASSETS $7,584  $8,776  $13,143  $5,602 
              
LIABILITIES AND STOCKHOLDERS’ EQUITY              
Current liabilities              
Accounts payable 
$
1,427
  
$
1,133
  $1,387  $1,488 
Accrued compensation  
1,242
   
1,498
  1,695  1,592 
Current portion of operating lease liability  
181
   
  196  186 
Current portion of finance lease liability 17   
Other current liabilities  
87
   
209
   40   85 
Total current liabilities  2,937   2,840  3,335  3,351 
Operating lease liability  
309
   
  160  261 
Finance lease liability  46    
Total liabilities  3,246   2,840  3,541  3,612 
              
Commitments and contingencies  
   
       
              
Stockholders’ equity              
Series A junior participating preferred stock as of September 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 September 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 September 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 0 and 0 shares, respectively, issued and outstanding 0 and 0, respectively        
Preferred stock as of September 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 39,969,465 and 39,969,465 shares, respectively, none outstanding  
   
 
Common stock as of September 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 2,879,162 and 513,445, respectively  
   
 
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  
216,173
   
204,101
  234,381  218,278 
Accumulated other comprehensive income:              
Foreign currency translation adjustment  
1,219
   
1,223
  1,209  1,214 
Accumulated deficit  
(213,054
)
  
(199,388
)
  (225,992)  (217,502)
Total stockholders’ equity  4,338   5,936   9,602   1,990 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $7,584  $8,776  $13,143  $5,602 

See notes to the condensed consolidated financial statements.

3

CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)

 
Three months ended
September 30,
 
Nine months ended
September 30,
  
Three months ended
June 30,
  
Six months ended
June 30,
 
 2019 2018 2019 2018  2020  2019  2020  2019 
Net sales 
$
1,252
  
$
1,363
  
$
4,144
  
$
3,499
  $1,863  $1,677  $3,493  $2,892 
Costs and expenses:                            
Cost of goods sold  
540
   
915
   
1,987
   
2,686
  664  835  1,460  1,447 
Selling, general and administrative  
4,107
   
3,713
   
12,098
   
11,489
  4,234  3,973  8,770  7,991 
Research and development  
1,112
   
985
   
3,719
   
2,107
   885   1,297   1,749   2,607 
Total costs and expenses  
5,759
   
5,613
   
17,804
   
16,282
   5,783   6,105   11,979   12,045 
Loss from operations  
(4,507
)
  
(4,250
)
  
(13,660
)
  
(12,783
)
  (3,920)  (4,428)  (8,486)  (9,153)
Other income (loss), net  
(1
)
  
10
   
(1
)
  
10
 
Loss before income taxes  
(4,508
)
  
(4,240
)
  
(13,661
)
  
(12,773
)
 (3,920) (4,428) (8,486) (9,153)
Income tax expense  
(1
)
  
(1
)
  
(5
)
  
(3
)
  (2)  (2)  (4)  (4)
Net loss $(4,509) $(4,241) $(13,666) $(12,776) $(3,922) $(4,430) $(8,490) $(9,157)
                            
Basic and diluted loss per share $(1.70) $(8.50) $(9.49) $(34.59) $(0.10) $(1.93) $(0.37) $(8.82)
                            
Weighted average shares outstanding – basic and diluted  
2,646
   
499
   
1,915
   
369
  37,923  2,295  27,181  1,550 
                            
Other comprehensive loss:                            
Foreign currency translation adjustments 
$
1
  
$
(1
)
 
$
(4
)
 
$
(2
)
 $(2) $(3) $(5) $(5)
Total comprehensive loss $(4,508) $(4,242) $(13,670) $(12,778) $(3,924) $(4,433) $(8,495) $(9,162)

See notes to the condensed consolidated financial statements.
4

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
  
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 
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 and stock awards, 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
  
   
   
   
   
(4,354
)
  
(4,354
)
 
  
  
  
  
(4,430
)
 
(4,430
)
Foreign currency translation adjustment  
   
   
   
1
   
   
1
  
  
  
  
(3
)
 
  
(3
)
Stock-based compensation, net  
3
   
   
501
   
   
   
501
  
  
  
339
  
  
  
339
 
Conversion of preferred stock into common stock  
32,365
   
   
   
   
   
   
259,300
   
   
   
   
   
 
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 and stock awards, 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 
Net loss
  
   
   
   
   
(4,241
)
  
(4,241
)
Foreign currency translation adjustment  
   
   
   
(1
)
  
   
(1
)
Stock-based compensation and stock awards, net  
3
   
   
437
   
   
   
437
 
Issuance of common stock, net  
181,941
   
   
4,649
   
   
   
4,649
 
Conversion of preferred stock into common stock  
1,516
   
   
   
   
   
 
Balance September 30, 2018  505,315  
$
  
$
203,560  $1,225  $(195,132) $9,653 
Balance June 30, 2019  2,328,320  $  $215,761  $1,218  $(208,545) $8,434 

 
Outstanding
Shares of
Common Stock
 
Common
Stock
 
Additional
Paid in
Capital
 
Accumulated
Other
Comprehensive
Income
 
Accumulated
Deficit
 
Stockholders’
Equity
  
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 
Balance December 31, 2019 4,674,068  $  $218,278  $1,214  $(217,502) $1,990 
Net loss
  
   
   
   
   
(4,727
)
  
(4,727
)
 
  
  
  
  
(4,568
)
 
(4,568
)
Foreign currency translation adjustment  
   
   
   
(2
)
  
   
(2
)
 
  
  
  
(3
)
 
  
(3
)
Stock-based compensation, net  
3
   
   
362
   
   
   
362
  
  
  
380
  
  
  
380
 
Issuance of common and preferred stock, net  
455,178
   
   
10,959
   
   
   
10,959
  
10,207,759
  
3
  
9,613
  
  
  
9,616
 
Exercise of warrants 
898,050
  
  
289
  
  
  
289
 
Conversion of preferred stock into common stock  
1,100,394
   
   
   
   
   
   
11,362,513
   
   
   
   
   
 
Balance March 31, 2019
  2,069,020  $  $215,422  $1,221  $(204,115) $12,528 
Balance March 31, 2020  27,142,390  $3  $228,560  $1,211  $(222,070) $7,704 
Net loss
  
   
   
   
   
(4,430
)
  
(4,430
)
 
  
  
  
  
(3,922
)
 
(3,922
)
Foreign currency translation adjustment  
   
   
   
(3
)
  
   
(3
)
 
  
  
  
(2
)
 
  
(2
)
Stock-based compensation, net  
   
   
339
   
   
   
339
  
  
  
347
  
  
  
347
 
Issuance of common stock, net 
8,728,108
  
1
  
3,423
  
  
  
3,424
 
Exercise of warrants 
6,838,225
  
  
2,051
  
  
  
2,051
 
Conversion of preferred stock into common stock  
259,300
   
   
   
   
   
   
488,090
   
   
   
   
   
 
Balance June 30, 2019
  2,328,320  $  $215,761  $1,218  $(208,545) $8,434 
Net loss
  
   
   
   
   
(4,509
)
  
(4,509
)
Foreign currency translation adjustment  
   
   
   
1
   
   
1
 
Stock-based compensation, net  
   
   
412
   
   
   
412
 
Conversion of preferred stock into common stock  
550,842
   
   
   
   
   
 
Balance September 30, 2019  2,879,162  $  $216,173  $1,219  $(213,054) $4,338 
Balance June 30, 2020  43,196,813  $4  $234,381  $1,209  $(225,992) $9,602 

See notes to the condensed consolidated financial statements.statements

5

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

 
Nine months ended
September 30,
  
Six months ended
June 30,
 
 
2019
 2018  
2020
  2019 
Operating Activities:           
Net loss 
$
(13,666
)
 
$
(12,776
)
 $(8,490) $(9,157)
Adjustments to reconcile net loss to cash flows used in operating activities:              
Depreciation and amortization  
179
   
174
  151  120 
Stock-based compensation expense, net  
1,113
   
1,544
  727  701 
Loss on disposal of property and equipment 46   
Changes in operating assets and liabilities:              
Accounts receivable  
258
   
(242
)
 (179) (146)
Inventory  
(158
)
  
(360
)
 (1,104) (32)
Other current assets  
(74
)
  
(104
)
 20  (75)
Other assets and liabilities  
(27
)
  
  112  (18)
Accounts payable and accrued expenses  
38
   
(79
)
  (43)  (267)
Net cash used in operating activities  (12,337
)
  (11,843
)
 (8,760) (8,874)
              
Investing Activities:              
Purchases of property, plant and equipment  
(464
)
  
(177
)
Purchases of property and equipment  (69)  (158)
Net cash used in investing activities  (464)  (177) (69) (158)
              
Financing Activities:              
Net proceeds from public stock offering, net  
10,959
   
4,649
 
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  10,959   4,649  15,376  10,959 
              
Effect of exchange rate changes on cash  
(4
)
  
(2
)
  (5)  (5)
Net decrease in cash and cash equivalents  
(1,846
)
  
(7,373
)
Net increase in cash and cash equivalents 6,542  1,922 
Cash and cash equivalents - beginning of period  
5,480
   
15,595
   1,279   5,480 
Cash and cash equivalents - end of period $3,634  $8,222  $7,821  $7,402 
              
Supplemental schedule of non-cash activities:        
Supplemental cash flow information      
Cash paid for income taxes $  $ 
Inventory transferred to property, plant and equipment 
$
204
  $  $112  $ 
Equipment acquired through finance lease liability $67  $ 

See notes to the condensed consolidated financial statements.
 
6

CHF SOLUTIONS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)

Note 1 – Nature of Business and Basis of Presentation

Nature of Business: CHF Solutions, Inc. (the “Company”) is a medical device company focused on developing, manufacturing and commercializing the Aquadex FlexFlow® systemand Aquadex SmartFlow™ systems (herein referred to as the “Aquadex System”) for aquapheresisultrafiltration therapy. The Aquadex FlexFlowSmartFlow system (“Aquadex FlexFlow”) is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy andor extended (longer than 8 hours) ultrafiltration treatment ofhours in patients withwho require hospitalization) use in adult and pediatric patients weighing 20kg or more whose fluid overload who have failed diuretic therapy and require hospitalization. The Company has submitted an applicationis unresponsive to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or moremedical management, including diuretics. CHF Solutions, Inc. is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia, Ireland and Delaware. The Company has been listed on Nasdaq since February 2012.
 
Previously, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the business associated with the Aquadex FlexFlow system (herein referred to as the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business.

In December 2018, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-2 to 1-for 14 and, in January 2019, the board of directors approved a 1-for-14 reverse split of the Company’s outstanding common stock that became effective after trading on January 2, 2019.  This reverse stock split did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation.  All share and per-share amounts have been retroactively adjusted to reflect the reverse stock split for all periods presented.

Principles of Consolidation: The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could materially differ from these estimates.

For further information, refer to the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.2019.

Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2019 and 2018 and 2017 and through SeptemberJune 30, 2019,2020, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. As of SeptemberJune 30, 2019,2020, the Company had an accumulated deficit of $213.1$226.0 million and it expects to incur losses for the immediate future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months.

The Company became a revenue generating company after acquiring the Aquadex Business in August 2016.  The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company.  To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex FlexFlow.System. This will require the Company to succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing and distributing the Aquadex FlexFlowSystem and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability.

7

On April 24, 2017, November 27, 2017, July 3,During 2018, March 12, 2019, October 25, 2019 and November 6, 2019,through May 5, 2020, the Company closed on underwritten public and other equity offerings for aggregate net proceeds of approximately $41.4$30.3 million after deducting the underwriting discounts and commissions or placement agents fees and offering expenses, as applicable, and other costs associated with the offerings (seeofferings. See Note 4 –Equity and Note 10-Subsequent Events).3 –Shareholder’s Equity. The Company will require additional funding to grow its Aquadex Business,business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions.  Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern.

7

Revenue Recognition: The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers, which the Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods and services. See Note 2 – Revenue Recognition, for additional disclosures.  For the three months ended SeptemberJune 30, 2019, three customers represented 11%, 12% and 12% of net sales. For the nine months ended September 30, 2019,2020, one customer represented 10% of net sales. For the threesix months ended SeptemberJune 30, 2018,2020, two customers each represented 15% and 10% of net sales.   For the ninethree months and six months ended SeptemberJune 30, 2018,2019, one customer represented 10%20% and 12% of net sales.sales, respectively.

Accounts Receivable:  Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and managements’ evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of SeptemberJune 30, 20192020 or December 31, 2018.2019.  As of SeptemberJune 30, 2019,2020, two customers represented 14%20% and 12%15% of the accounts receivable balance.  As of December 31, 2018, three2019, two customers represented 18%, 13% and 13%12% of the accounts receivable balance.

Inventories:  Inventories are recorded as the lower of cost or net realizable value using the first-in, firstfirst-in-first out method.  Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities.  Abnormal amounts of overhead, if any, are expensed as incurred.  Inventories consisted of the following:

( in thousands) 
September 30,
2019
  
December 31,
2018
 
Finished Goods
 
$
468
  
$
517
 
Work in Process
  
185
   
34
 
Raw Materials
  
959
   
1,107
 
Total 
$
1,612
  
$
1,658
 

Contingent consideration: In connection with the Company’s purchase of the Aquadex Business in August 2016, the Company had an obligation to pay additional consideration that was contingent upon the occurrence of certain future events (see Note 9 - Commitments and Contingencies).  Contingent consideration was recognized at the acquisition date at $126,000, the estimated fair value of the contingent milestone payments.  The fair value of the contingent consideration was remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings.  As of September 30, 2019, this contingency had expired, therefore its fair value was $0.
(in thousands) 
June 30,
2020
  
December 31,
2019
 
Finished Goods $1,044  $750 
Work in Process  464   79 
Raw Materials  1,281   968 
Total $2,789  $1,797 

Loss per share: Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the ninesix months ended SeptemberJune 30, 2020, reflects a $1.6 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series H Convertible Preferred Stock on January 28, 2020. The net loss allocable to common stockholders for the six months ended June 30, 2019, reflects a $4.5 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series G Convertible Preferred Stock on March 12, 2019 (see Note 4 - Equity), representing2019. The deemed dividends represent the intrinsic value of the preferred shares at the time of issuance. See Note 3 – Shareholders’ Equity for additional disclosures.

Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans.
 
The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented:

 September 30  June 30 
 2019  2018  2020  2019 
Warrants to purchase common stock
 
5,430,721
  
608,787
  22,935,559  5,430,721 
Series G convertible preferred stock   550,842 
Series F convertible preferred stock
 
102,185
  
19,210
 
1,450,290  102,185 
Stock options
 
332,722
  
139,439
   519,713   241,635 
Restricted stock units
  -
   
3
 
Total  
5,865,628
   
767,439
   24,905,562   6,325,383 

The following table reconciles reported net loss with reported net loss per share for each of the periodssix months ended September 30, 2019:June 30:

(in thousands, except per share amounts) 
Three
months
 
Nine
months
  2020  2019 
Net loss
 
$
(4,509
)
 
$
(13,666
)
 $(8,490) $(9,157)
Deemed dividend to preferred shareholders (see Note 4)  
   
(4,509
)
Deemed dividend to preferred shareholders (see Note 3)  (1,588)  (4,509)
Net loss after deemed dividend
  
(4,509
)
  
(18,175
)
 (10,078) (13,666)
Weighted average shares outstanding  
2,646
   
1,915
   27,181   1,550 
Basic and diluted loss per share
 
$
(1.70
)
 
$
(9.49
)
 $(0.37) $(8.82)

New Accounting Pronouncements:Subsequent Events:  In February 2016, the Financial Accounting Standards Board (“FASB”) issued updated guidance to improve financial reporting about leasing transactions. This guidance required organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. The original guidance required application on a modified retrospective basis with the earliest period presented. In August 2018, the FASB issued new guidance which included an option to not restate comparative periods in transition. The Company adopted this new standard on January 1, 2019 with no retrospective adjustments to prior comparative periods. The adoption of this standard on January 1, 2019 resulted in an increase of approximately $0.6 million inevaluates events through the Company’s other long-term assets and in short and long-term liabilities recorded on its consolidated balance sheet. In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. See Note 7 –Operating Leases for additional qualitative and quantitative disclosures

In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value.  The Company early-adopted the guidance effective in its second quarter and the effect ondate the consolidated financial statements was not material.are filed for events requiring adjustment to or disclosure in the consolidated financial statements.

Note 2 – Revenue Recognition

Net Sales
The Company sells its products in the United States primarily through a direct sales force. Customers who purchase the Company’s products include hospitals and clinics throughout the United States.  In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in the United Kingdom, Italy, Spain, Germany, Austria, Switzerland, Southeast Asia, Brazil, India, Greece, the United Arab Emirates, Israel and Greece.Palestine. These distributors resell the Company’s products to hospitals and clinics in their respective geographies.

Revenue from product sales are recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point, unless the customer requests that control and title to the inventory transfer upon delivery. Revenue includes shipment and handling fees charged to customers.

Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when we satisfy ourthe Company satisfies its performance obligations under the contract. The majority of ourthe Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers which are recognized over time. This revenue represents less than 1% of net sales for the three and ninesix months ended SeptemberJune 30, 20192020 and 2018.2019.  The unfulfilled performance obligations related to these extended service plans is included in deferred revenue, which is included in other current liabilities on the condensed consolidated balance sheet.sheets. The majority of the deferred revenue is expected to be recognized within one year.

Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold.

Product Returns:  The Company offers customers a limited right of return for its product in case of non-conformity or performance issues. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized.  The Company currently estimates product return liabilities using available industry data and its own historical sales and returns information.  The Company has not received any returns to date and believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns.

Note 3 - Debt

On August 5, 2016, the Company entered into a loan and security agreement with Silicon Valley Bank (the Bank).  Under this agreement, the Bank agreed to provide the Company with up to $5.0 million in debt financing, consisting of a term loan in an aggregate original principal amount not to exceed $4.0 million (the “Term Loan”) and a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”).  Proceeds from the loans were to be used for general corporate and working capital purposes.  Advances under the Term Loan were available to the Company until November 30, 2016 and were subject to the Company’s compliance with liquidity covenants. The Term Loan expired unused on November 30, 2016 and the Term Loan is no longer available to be drawn. Advances under the Revolving Line are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of September 30, 2019 or December 31, 2018.

Note 4 -– Stockholders’ Equity

Series F Convertible Preferred Stock: On November 27, 2017, the Company closed on an underwritten public offering of Series F convertible preferred stockConvertible Preferred Stock and warrants to purchase shares of common stock for gross proceeds of $18.0 million. Net proceeds totaled approximately $16.2 million after deducting the underwriting discounts and commissions and other costs associated with the offering.

The offering was comprised of Series F convertible preferred stock, convertible into shares of the Company’s common stock at an initial conversion price of $63.00 per share.  Each share of Series F convertible preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share.  The Series F convertible preferred stock and the warrants were immediately separable and were issued separately. The conversion price of the Series F preferred stock will be adjusted in the event of a stock split, combination, reclassification or stock dividend or if the Company consummates a fundamental transaction.  The Series F preferred stock also has full ratchet price based anti-dilution protection, subject to customary carve outs, in the event of a down-round financing at a price per share below the conversion price of the Series F convertible preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F convertible preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000).  The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions.  A total of 18,000 shares of Series F Convertible Preferred Stockconvertible preferred stock initially convertible into 286,714 shares of common stock and warrants to purchase 573,310 shares of common stock were issued in the offering.

10

As noted below, effectiveEffective July 3, 2018, the conversion price of the Series F convertible preferred stock was reduced from $63.00 to $29.68, the per share price in the July 2018 Offering described below. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced again from $29.68 to $5.25, the per share price to the public of the Series G convertible preferred stock which closed in an underwritten public offering on March 12, 2019.  Effective October 25, 2019, and each sharethe conversion price of the remaining Series F convertible preferred stock is convertible into 191 shareswas reduced from $5.25 to $1.41, and on November 6, 2019 from $1.41 to $0.9942, the per share price to the public in the October and November 2019 transactions, respectively, described below.  Effective January 28, 2020, the conversion price of the Company’s common stock.Series F convertible preferred stock was reduced from $0.9942 to $0.55, the per share price to the public of the Series H convertible preferred stock which closed in an underwritten public offering on January 28, 2020. Effective March 23, 2020, the conversion price of the Series F convertible preferred stock was reduced from $0.55 to $0.30, the per share price to the public in the March 2020 transaction, described below. As of both SeptemberJune 30, 2019,2020, and December 31, 2018,31,2019, 435 and 535 shares of the Series F convertible preferred stock remained outstanding.outstanding, respectively.

July 2018 Offering: On July 3, 2018, the Company closed on an underwritten public offering of 181,941 shares of its common stock at a public offering price of $29.68 per share, for gross proceeds of $5.4 million, including the full exercise of the underwriters’ over-allotment option to purchase additional shares of the Company’s common stock (the “July 2018 Offering”). Net proceeds totaled approximately $4.6 million after deducting underwriting discounts and commissions and offering expenses.

In connection with the July 2018 Offering, and to induce certain institutional investors who hold warrants issued by the Company in November 2017 (“November 2017 Warrants”) to participate in the July 2018 Offering, the Company entered into letter agreements with such institutional investors.  Pursuant to the terms of these agreements, the Company agreed, effective July 3, 2018, to reduce the per share exercise price of the November 2017 Warrants held by such institutional investors to $29.68 and to extend the expiration date of the warrants that were to expire on November 27, 2018 to November 27, 2019. The number of common shares underlying the warrants that were repriced did not change. The repriced warrants arewere exercisable for 554,322 shares of common stock in the aggregate, of which, following such amendment, half expireexpired on November 27, 2019 and half will expire on November 27, 2024. The repricing of the warrants was accounted as an equity financing cost, with no impact to net proceeds from the offering.

As noted above, the Company’s outstanding Series F preferred stock is subject to full-ratchet anti-dilution protection in the event the Company sells any common stock at a price lower than the then-conversion price of the Series F preferred stock. As a result of the July 2018 Offering, effective July 3, 2018, the conversion price of the Series F preferred stock was reduced from $63.00 to $29.68, the per share price in the July 2018 Offering.

Series G Convertible Preferred Stock and March 2019 Offering: On March 12, 2019, the Company closed on an underwritten public offering of common stock, Series G convertible preferred stock and warrants to purchase shares of common stock for gross proceeds of $12.4 million, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants (“March 2019 Offering”). Net proceeds totaled approximately $11.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Series G convertible preferred stock included a beneficial conversion amount of $4.5 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the ninesix months ended SeptemberJune 30, 2019.

The March 2019 Offering was comprised of 455,178 shares of common stock priced at $5.25 per share and 1,910,536 shares of Series G convertible preferred stock, convertible into common stock at $5.25 per share. Each share of Series G convertible preferred stock and each share of common stock was accompanied by a Series 1 warrant and a Series 2 warrant.  The Series 1 warrants are exercisable into 2,365,714 shares of common stock and the Series 2 warrants are exercisable into 2,365,714 shares of common stock. Series 1 warrants expire on the fifth anniversary of the date of issuance and are exercisable at $5.25 to purchase one share of common stock. Series 2 warrants expire on the earlier of: (i) the eighteen-month anniversary of the date of issuance and (ii) the 30th trading day following the public announcement of the receipt from the U.S. Food and Drug Administration (FDA) of clearance or approval of a modification to the product label for the Aquadex FlexFlow systemSystem to include pediatric patients. Series 2 warrants are exercisable at $5.25 per share of common stock. The Company announced it had received FDA clearance for use of its Aquadex System in pediatric patients on February 26, 2020, effectively setting the date of expiration of these warrants for April 8, 2020. The conversion price of the Series G convertible preferred stock as well as the exercise price of the warrants are fixed and do not contain any variable pricing features, nor any price based anti-dilutive features apart from customary adjustments for splits and reverse splits of common stock.  The Series G convertible preferred stock included a beneficial ownership limitation of 4.99% but had no dividend preference (except to extent dividends are also paid on the common stock), liquidation preference or other preferences over common stock. The securities comprising the units were immediately separable and were issued separately.

As of SeptemberJune 30, 2020, and December 31, 2019, all 1,910,536 shares of the Series G convertible preferred stock had been converted into common stock and none remained outstanding.

As noted above, the Company’s outstanding Series F convertible preferred stock is subject to full-ratchet anti-dilution protection in the eventOctober and November 2019 Offerings: On October 25, 2019, the Company sells anyclosed on a registered direct offering of 575,830 shares of common stock at a price lower thanof $1.15 per share, for gross proceeds of approximately $660,000, prior to deducting commissions and expenses related to the then-conversiontransaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 575,830 shares of its common stock at an exercise price of $1.41 per share, which will be exercisable six months from the date of issuance, and will expire five years from the initial exercise date. On November 6, 2019, the Company closed on a registered direct offering of 1,219,076 shares of common stock, or common equivalents, at a price of $1.12 per share, for gross proceeds of approximately $1.36 million prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,219,076 shares of our common stock at an exercise price of $0.9942 per share, which were exercisable upon the date of issuance, and will expire five years from the initial exercise date.
The unregistered warrants issued in each offering were subsequently registered pursuant to a registration statement on Form S-1 that was declared effective by the Securities and Exchange Commission (“SEC”) on December 30, 2019.

Series FH Convertible Preferred Stock and January 2020 Offering: On January 28, 2020, the Company closed on an underwritten public offering of common stock, Series H convertible preferred stock. As a resultstock and warrants to purchase shares of common stock for gross proceeds of $9.7 million, which included the full exercise of the March 2019underwriter’s over-allotment option to purchase additional shares and warrants (“January 2020 Offering”). Net proceeds totaled approximately $8.6 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Series H convertible preferred stock included a beneficial conversion amount of $1.6 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the six months ended June 30, 2020.

The January 2020 Offering was comprised of 6,046,367 shares of common stock priced at $0.55 per share and 11,517,269 shares of Series H convertible preferred stock, convertible into common stock at $0.55 per share, including the full exercise of the over-allotment option. Each share of Series H convertible preferred stock and each share of common stock was accompanied by a warrant to purchase common stock.  The warrants are exercisable into 17,563,636 shares of common stock. The conversion price of the Series Fpreferred stock issued in the transaction is fixed and does not contain any variable pricing feature or any price based anti-dilutive feature. The preferred stock issued in this transaction includes a beneficial ownership blocker but has no dividend rights (except to the extent that dividends are also paid on the common stock) or liquidation preference, and, subject to limited exceptions, has no voting rights. The securities comprising the units are immediately separable and were issued separately. The warrants are exercisable beginning on the closing date and expire on the fifth anniversary of the closing date and have an initial exercise price per share equal to $0.55 per share, subject to appropriate adjustment in the event of subsequent equity sales of common stock or securities convertible preferredinto common stock for an exercise price per share less than the exercise price per share of the warrants then in effect (but in no event lower than 10% of the applicable Unit offering price), or in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting our common stock. Effective March 23, 2020, the exercise price of these warrants was reduced from $29.68,$0.55 to $5.25,$0.30, the per share price to the public in the March 2020 offering, described below.

As of June 30, 2020, all 11,517,269 shares of the Series GH convertible preferred stock had been converted into common stock and none remained outstanding.  As of June 30, 2020, warrants to purchase 7,736,275 shares of common stock had been exercised for total cash proceeds of $2.3 million.

March 2020 Offering: On March 23, 2020, the Company closed on a registered direct offering of 4,161,392 shares of its common stock at a price to the public of $0.30 per share, for gross proceeds of approximately $1.2 million, or $1.0 million net after deducting commissions and offering expenses payable by CHF Solutions. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 4,161,392 shares of the Company’s common stock.

The warrants to purchase up to 4,161,392 shares of common stock have an exercise price of $0.3726 per share, will be exercisable six months from the date of issuance, and will expire five and a half years from the date of issuance. On April 29, 2020, the Company filed a registration statement to register the shares of common stock issuable upon exercise of the warrants. The registration statement was declared effective by the SEC on May 8, 2020.

April 2020 Offering: On April 1, 2020 the Company closed on a registered direct offering of 5,130,228 shares of its common stock at a price to the public of $0.434 per share, for gross proceeds of approximately $2.2 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 2,565,114 shares of the Company’s common stock.  The warrants have an exercise price of $0.3715 per share, are exercisable immediately, and will expire five and a half years from the date of issuance. On April 29, 2020, the Company filed a registration statement to register the shares of common stock issuable upon exercise of these warrants and the warrants issued in the March 2020 transaction. The registration statement was declared effective by the SEC on May 8, 2020.

May 2020 Offering: On May 5, 2020 the Company closed on a registered direct offering of 3,597,880 shares of its common stock at a price to the public of $0.4725 per share, for gross proceeds of approximately $1.7 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,798,940 shares of the Company’s common stock.  The warrants have an exercise price of $0.41 per share, are exercisable immediately, and will expire five and a half years from the date of issuance. On May 29, 2020, the Company filed a registration statement to register the shares of common stock issuable upon exercise of the warrants. The registration statement was declared effective by the SEC on June 8, 2020.

Placement Agent Fees: In connection with the issuance of the Series F convertible preferred stock, the July 2018 Offering, and the March 2019 Offering,offerings described above, the Company paid the placement agent an aggregate cash placement fee equal to 8% of the aggregate gross proceeds raised in each of the offering and issued no warrants to the placement agent.offerings.

Market-Based Warrants: On May 30, 2019, the Company granted a market-based warrant to a consultant in exchange for investor relations services.  The warrant represents the right to acquire up to 100,000 shares of the Company’s common stock at an exercise price of $3.18 per share, the closing stock price of the Company’s common shares on May 30, 2019. The warrant is subject to a vesting schedule based on the Company achieving certain market stock prices within a specified period of time.  The warrant expires on May 30, 2024. The warrant was valued at $1.93 per share using the Monte Carlo valuation methodology and is beingwas expensed over the term of the consulting engagement which iswas twelve months.  Significant inputs used for the Monte Carlo valuation were the expected stock price volatility of 136.21%, and management’s expectations regarding the timing of regulatory clearance for an expanded label in pediatrics.  None of these warrants had vested as of June 30, 2020.

Note 54 - Stock-Based Compensation

Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation, the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period.

The following table presents the classification of stock-based compensation expense recognized for the periods below:

 
Three months ended
September 30,
 
Nine months ended
September 30,
  
Three months ended
June 30,
  
Six months ended
June 30,
 
(in thousands) 2019 2018 2019 2018  2020  2019  2020  2019 
Selling, general and administrative expense $383  $440  $1,018  $1,446  $321  $309  $675  $635 
Research and development expense  
29
   
(3
)
  
95
   
98
   26  30  52  66 
Total stock-based compensation expense $412  $437  $1,113  $1,544  $347  $339  $727  $701 

Note 65 - Fair Value of Financial Instruments

The Company’s financial instruments consist of cash and cash equivalents warrants, and contingent consideration.warrants.

Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” theThe Company’s financial assets and liabilities are measured at fair value on a recurring basis and are classified and disclosed in one of the following three categories:

Level 1 - Financial instruments with unadjusted quoted prices listed on active market exchanges.

Level 2 - Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over the counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.

Level 3 - Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation techniques.

The fair value of the Company's contingent consideration, as described in Note 1, was initially measured based on the consideration expected to be transferred (probability-weighted), discounted back to present value, and it was considered a Level 3 instrument. The discount rate used was determined at the time of measurement in accordance with accepted valuation methods. The Company measured the liability on a recurring basis using Level 3 inputs including probabilities of payment and projected payment dates. As of September 30, 2019, this contingency had expired, therefore its fair value was recorded at $0.

12

The following is a rollforward of the fair value of Level 3 items:
(in thousands)   
Balance December 31, 2018 $126 
Change in fair value
  
(126
)
Balance as of September 30, 2019
 
$
-
 

The fair value of the market-based warrants described in Note 4 was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy.  These warrants are classified as permanent equity and as a result, were measured at the grant date and are not required to be remeasured to fair value at each reporting period end.

All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or any other classified as Level 3 and there were no movements between these categories during the periods ended Septemberas of June 30, 20192020 and December 31, 2018.2019. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities.

Note 7 – Operating Leases

The Company leases office and manufacturing space under a non-cancelable operating lease that expires in March 2022. In August 2018, the Company entered into a third amendment to the lease, extending the term of the lease from March 31, 2019 to March 31, 2022. Beginning on April 1, 2019, the annual base rent is $9.00 per square foot, subject to annual increases of $0.25 per square foot.

The cost components of the Company’s operating lease were as follows for the three and nine months ended September 30, 2019:

(in thousands) Three Months  Nine Months 
Operating lease cost $53  $158 
Variable lease cost  
26
   
85
 
Total $79  $243 

Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased office and manufacturing space.

Maturities of our lease liability for the Company’s operating lease are as follows as of September 30, 2019:

(in thousands)   
2019 $52 
2020  213 
2021  219 
2022  55 
Total lease payments  
539
 
Less: Interest  
(49
)
Present value of lease liability $490 

As of September 30, 2019, the remaining lease term was 2.5 years and discount rate was 7.5%. For the nine months ended September 30, 2019, the operating cash outflows from the Company’s operating lease for office and manufacturing space were $154,000.

13

Rent expense related to operating leases for office and manufacturing space and office equipment was approximately $54,000 and $160,000 for the three and nine months ended September 30, 2018, respectively.  Future minimum lease payments, under non-cancelable operating leases as of December 31, 2018, were approximately $217,000, $220,000, $219,000, $55,000, and $0 for each of the years ended December 31, 2019, through 2023, respectively.

Note 86 – Income Taxes

The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a full valuation allowance for U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying condensed consolidated financial statements.

As of SeptemberJune 30, 2019,2020, there were no material changes to what the Company disclosed regarding tax uncertainties or penalties in its Annual Report on Form 10-K for the year ended December 31, 2018.2019.

Note 9—7—Finance Lease Liability

In June 2020, the Company entered into a lease agreement to finance equipment valued at $67,000.  The equipment consisted of computer hardware and is included in Property, Plant and Equipment in the accompanying condensed consolidated financial statements.  The principal amount under the lease agreement was $64,000 at the date the lease commenced, the implied interest rate is 7.5%, and the term of the lease is 39 months.

Note 8—Commitments and Contingencies

Paycheck Protection Program:  On April 21, 2020, the Company announced it had received of $1.66 million under the Paycheck Protection Program (PPP) under the federal Coronavirus Aid, Relief, and Economic Security (CARES) Act. Subsequent to the Company applying and receiving the funds under the PPP, the United States Treasury Department and the U.S. Small Business Administration issued new guidance regarding eligibility for these loans. As a result, on May 12, 2020, the Company announced it had elected to return all funds it had received under the PPP, so that these funds could be used to help another small business in greater need during the COVID-19 pandemic.

Employee Retirement Plan: The Company has a 401(k)-profit sharing plan that provides retirement benefit to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service (“IRS”) limitations, with the Company matching a portion of the employee’s contributions at the discretion of the Company.

Contingent Consideration: As part of the acquisition of the Aquadex Business from Baxter in August 2016, the Company agreed that if it disposed of any of the Aquadex assets for a price that exceeded $4.0 million within three years of the closing, it would pay Baxter 40% of the amount of such excess.  This commitment expired on August 6, 2019.

In addition, it also agreed that if shares of its common stock cease to be publicly traded on the Nasdaq Capital Market, Baxter has the option to require the Company to repurchase, in cash, all or any part of the common shares held by Baxter at a price equal to their fair market value, as determined by a third-party appraiser.

Note 10 – Subsequent Events

On October 25, 2019, the Company closed on a registered direct offering of 575,830 shares of its common stock at a price of $1.15 per share, for gross proceeds of approximately $660,000, prior to deducting commissions and expenses related to the transaction.  In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 575,830 shares of the Company’s common stock at an exercise price of $1.41 per share, which will be exercisable six months from the date of issuance, and will expire five years from the initial exercise date.

Additionally, the Company’s outstanding Series F preferred stock is subject to full-ratchet anti-dilution protection in the event the Company sells any common stock at a price lower than the then-conversion price of the Series F preferred stock. As a result of this offering, effective October 25, 2019, the conversion price of the Series F preferred stock was reduced from $5.25 to $1.15 per share, the per share price to the public in this transaction.

On November 6, 2019, the Company closed on a registered direct offering of 1,219,076 shares of its common stock, or common equivalents, at a price of $1.12 per share, for gross proceeds of approximately $1.36 million prior to deduction of commissions and offering expenses related to the transaction.  In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,219,076 shares of the Company’s common stock at an exercise price of $0.9942 per share, which will be exercisable upon the date of issuance, and will expire five years from the initial exercise date. Effective November 6, 2019, the conversion price of the Series F preferred stock was reduced from $1.15 to $0.9942, the exercise price of the warrants issued in connection with this financing.

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ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our interim condensed consolidated financial statements and related notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q and the audited consolidated financial statements and related notes and Management’s Discussion andand Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2018.2019. This discussion contains forward-looking statements that involve risks and uncertainties.  Our actual results could differ materially from those anticipated in the forward-looking statements as a result of a variety of factors, including those discussed in Part I, Item 1A “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 20182019, in our Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in our subsequent filings with the Securities and Exchange Commission (SEC).

13

Unless otherwise specified or indicated by the context, CHFthe terms “CHF Solutions, Company, we, us” the “Company,” “we,” “us,” and our,“our”, refer to CHF Solutions, Inc. and its subsidiaries.

OVERVIEW

About CHF Solutions

We are a medical device company focused on developing, manufacturing and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow™ systems (herein referred to as the “Aquadex System”) for ultrafiltration therapy.  The Aquadex SmartFlow system for aquapheresis therapy.delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex FlexFlowSmartFlow system is indicated for temporary (up to eight8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy andor extended (longer than 8 hours) ultrafiltration treatment ofhours in patients withwho require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload who have failed diuretic therapy and require hospitalization. In the United States, we hold 510(k) clearance from the FDAis unresponsive to market and sell the Aquadex FlexFlow system to adults. We have submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more, which we expect to receive in Q1 2020In the European Union (“EU”), we are required to hold a CE Mark to import our product into the EU.  The CE Mark for the Aquadex FlexFlow system had previously expired.  We received renewal for the Aquadex FlexFlow circuit in the second quarter of 2019 and expect to receive renewal for the Aquadex FlexFlow console in the fourth quarter of 2019, which would allow us to import additional console inventory into the EU.  We believe that we currently have sufficient inventory of consoles already available for sale in the EU market and the timing of the receipt of the CE Mark for the console will not have a material impact on our revenue.medical management, including diuretics.

Previously, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the business associated with the Aquadex FlexFlow system (herein referred to as the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”) and refocused its strategy to fully devote its resources onto the Aquadex Business.

Impact of COVID-19 Pandemic

During the first six months of 2020, we were subject to challenging social and economic conditions created as a result of the outbreak of the novel strain of coronavirus, SARS-CoV-2 (“COVID-19”). The resulting impact of the COVID-19 pandemic created disruptions in our operations resulting from rapid and evolving changes implemented to keep our customers, their patients, and our employees safe. These changes included restrictions on hospital access imposed on our field employees by customers dealing in the front lines of COVID-19 and managing the spread of the virus, changes to employees work practices by requiring employees to work remotely and increased protocols to ensure the safety of those employees that remained on site.  The extent of the impact of the COVID-19 outbreak on our operational and financial performance will depend on certain developments, including the duration and spread of the outbreak, impact on our customers and our sales cycles, employee or industry events, and effect on our vendors, all of which are uncertain and cannot be predicted.

We may experience constrained supply or curtailed customer demand that could materially adversely impact our business, results of operations and overall financial performance in future periods. Specifically, we may experience negative impacts from changes in how we conduct business due to the COVID-19 pandemic, including but not limited to restrictions on travel and in-person meetings, production delays, warehouses and staffing disruptions and shortages, decreases or delays in customer demand and spending, difficulties or changes to our sales process and customer support.

Several hospitals in the U.S. have included the Aquadex System into their treatment protocol for fluid management of COVID-19, especially when dialysis equipment and staff are limited.  In March 2020, we increased production of the Aquadex System to meet anticipated demand due to its use in treatment protocols for COVID-19. We estimate that approximately 34% of our revenue for the second quarter of 2020 was driven by hospitals treating patients with COVID-19. However, we have also seen changes to our sales practices due to restrictions on hospital access and believe that revenue in other areas was negatively impacted by these restrictions.  In addition, the disruption created by COVID-19 has created significant uncertainty about our ability to access the capital markets in future periods. As of the filing date of this Form 10-Q, the extent to which COVID-19 may continue to impact our financial condition or results of operations or guidance is uncertain and cannot be reasonably estimated but could be material and last for an extended period of time. The effect of the COVID-19 pandemic may not be fully reflected in our results of operations and overall financial performance until future periods. See Part 1, Item 1-A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and in our Quarterly Report on Form 10-Q for the period ended March 31, 2020 for further discussion of the possible impact of the COVID-19 pandemic on our business.

Recent Developments

Pediatrics
In February 2020, we received 510(k) clearance of the Aquadex SmartFlow to include pediatric patients who weigh 20kg or more. The Aquadex System is being prescribed by physicians to treat various conditions in pediatric patients, including heart failure, cardiac surgery, extracorporeal membrane oxygenation (ECMO) therapy, solid organ transplantation, and kidney replacement therapy for neonatal patients.

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Public Offerings
On October 25, 2019,May 5, 2020, we closed on a registered direct offering of 575,8303,597,880 shares of common stock at a price to the public of $1.15$0.4725 per share, for gross proceeds of approximately $660,000,$1.7 million, prior to deductingdeduction of commissions and expensesoffering related to the transaction. In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 575,8301,798,940 shares of the Company’s common stock. The warrants have an exercise price of $0.41 per share, are exercisable immediately, and will expire five and a half years from the date of issuance. On May 29, 2020, we filed a registration statement to register the shares of common stock issuable upon exercise of the warrants. The registration statement was declared effective by the SEC on June 8, 2020.

On April 1, 2020, we closed on a registered direct offering of 5,130,228 shares of common stock at a price to the public of $0.434 per share, for gross proceeds of approximately $2.2 million, prior to deduction of commissions and offering related to the transaction. In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 2,565,114 shares of the Company’s common stock.  The warrants have an exercise price of $0.3715 per share, are exercisable immediately, and will expire five and a half years from the date of issuance.

On March 23, 2020, we closed on a registered direct offering of 4,161,392 shares of our common stock at an exercisea price to the public of $1.41$0.30 per share, which will be exercisable six months fromfor gross proceeds of approximately $1.2 million, prior to deduction of commissions and offering expenses associated with the datetransaction. In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 4,161,392 shares of issuance,the Company’s common stock. On April 29, 2020, we filed a registration statement to register the shares of common stock issuable upon exercise of the warrants that were issued on April 1, 2020 and will expire five years fromMarch 23, 2020. The registration statement was declared effective by the initial exercise date.SEC on May 8, 2020.

Additionally, ourOn January 28, 2020, we closed on an underwritten public offering of 6,046,367 shares of common stock, 11,517,269 shares of Series H Preferred Stock and warrants to purchase 17,563,636 shares of common stock, which includes the full exercise of the underwriter’s over-allotment option, for gross proceeds of approximately $9.7 million. Net proceeds totaled approximately $8.6 million after deducting the underwriting discounts and commissions and other costs associated with the offering.

Our outstanding Series F preferred stock is subject to full-ratchet anti-dilution protection in the event we sell any common stock at a price lower than the then-conversion price of the Series F preferred stock. As a result of this offering,these offerings, effective October 25, 2019,January 28, 2020, the conversion price of the Series F convertible preferred stock was reduced from $5.25$0.9942 to $1.15$0.55, the per share price to the public of the Series H convertible preferred stock. Effective March 23, 2020, the conversion price of the Series F convertible preferred stock was reduced from $0.55 to $0.30, the per share price to the public in this transaction.the March 23, 2020 transaction, described above.

On November 6, 2019, we closed on a registered direct offeringAdditionally, the warrants issued in the January 28, 2020 transaction have price protection measures in the event of 1,219,076 sharessubsequent equity sales of common stock or securities convertible into common equivalents, at astock for an exercise price per share less than the exercise price per share of the warrants then in effect. Effective March 23, 2020, the exercise price of $1.12these warrants was reduced from $0.55 to $0.30, the per share for gross proceeds of approximately $1.36 million prior to deduction of commissions and offering expenses relatedprice to the transaction.  In a concurrent private placement, we agreed to issue to the investorspublic in the registered direct offering unregistered warrantsMarch 2020 transaction, described above.

Nasdaq Notice
On December 17, 2019, we received a letter (the “Notice”) from The Nasdaq Stock Market (“Nasdaq”) advising that for 30 consecutive trading days preceding the date of the Notice, the bid price of our common stock had closed below the $1.00 per share minimum required for continued listing on the Nasdaq Capital Market pursuant to purchase up to 1,219,076 sharesNasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Notice has no effect on the listing of our common stock at an exercise price of $0.9942 per share, which will be exercisable uponthis time, and our common stock continues to trade on the Nasdaq Capital Market under the symbol “CHFS.” Under Nasdaq Listing Rule 5810(c)(3)(A), if during the 180 calendar day period following the date of issuance, and will expire five years from the initial exercise date. Effective November 6, 2019,Notice (the “Compliance Period”), the conversionclosing bid price of our common stock is at or above $1.00 for a minimum of 10 consecutive business days, we will regain compliance with the Series F preferredMinimum Bid Price Requirement and our common stock was reduced from $1.15will continue to $0.9942,be eligible for listing on the exercise priceNasdaq Capital Market, absent noncompliance with any other requirement for continued listing. The Nasdaq letter further states that if compliance with the Minimum Bid Price Rule cannot be demonstrated by the end of the warrants issued180-day period, we may be eligible for a second 180-day period to regain compliance. To be eligible for the second 180 day compliance period, (i) we must meet the market value of publicly held shares requirement for continued listing and all other applicable standards for initial listing on The Nasdaq Capital Market set forth in connectionMarketplace Rule 5505 (except the bid price requirement), (ii) we must provide Nasdaq with this financing.

On March 12, 2019,written notice of its intention to cure the deficiency, through a reverse stock split, if necessary, and (iii) Nasdaq must determine that the Company will be able to cure the deficiency. If we closed on an underwritten public offeringdo not regain compliance with the Minimum Bid Price. Requirement by the end of 455,178 shares ofthe Compliance Period (or the Compliance Period as may be extended) the Company’s common stock approximately 1.9 million shares of Series G Convertible Preferred Stock, and warrantswill be subject to purchase approximately 4.7 million shares of common stock, which includes the full exercise of the underwriter’s over-allotment option, for gross proceeds of $12.4 million. Net proceeds totaled approximately $11.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering.delisting. At such time, we may appeal Nasdaq’s delisting determination.

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See Notes 4 and 10On April 17, 2020, Nasdaq notified us that the 180-day period to regain compliance with the Minimum Bid Price Rule has been extended due to the condensed consolidated financial statements included in Part I, Itemglobal market impact caused by COVID-19. More specifically, Nasdaq has stated that the compliance periods for any company previously notified about non-compliance are suspended effective April 16, 2020, until June 30, 2020.  On July 1, 2020, companies received the balance of any pending compliance period exception to regain compliance with the Minimum Bid Price Rule.  As a result of this Quarterly Report on Form 10-Q.extension, we now have until August 28, 2020 to regain compliance with the Minimum Bid Price Rule.

Reverse Stock Split
In December 2018,At our annual meeting of stockholders approved a reverse split of our outstanding common stock at a ratio in the range of 1-for-2(the “Annual Meeting”), held on May 20, 2020 and adjourned to 1-for-14 and, in January 2019,June 19, 2020, our board of directors approved a 1-for-14 reverse split of our outstanding common stock that became effective after trading on January 2, 2019. This reverse stock split did not change the par value of our common stock or the number of common or preferred shares authorized byproposed an amendment to the Company’s Fourth Amended and Restated Certificate of Incorporation. All share and per-share amounts have been retroactively adjustedIncorporation to reflect theeffect a reverse stock split for all periods presented.of our outstanding shares of common stock, which if implemented would increase the closing bid price of our common stock above $1.00.  There were insufficient votes to pass such proposal at the Annual Meeting.

We intend to monitor the closing bid price of our common stock through the Compliance Period.  If we have not regained compliance with the Minimum Bid Price before August 28, 2020, we intend to seek an 180-day extension to regain compliance with the Minimum Bid Price Requirement under the Nasdaq Listing Rules.

Promotion of Nestor Jaramillo, Jr.
On June 25, 2020, we announced that Nestor Jaramillo, Jr., our Chief Commercial Officer, was promoted to President and Chief Operating Officer effective July 1, 2020.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

We have adopted various accounting policies to prepare the condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States. (U.S. GAAP)(“U.S. GAAP”). Our most significant accounting policies are disclosed in Note 1 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018.2019.

The preparation of the condensed consolidated financial statements, in conformity with U.S. GAAP, requires us to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Our estimates and assumptions, including those related to stock-based compensation, valuation of equity and debt securities, and income tax reserves are updated as appropriate, which in most cases is quarterly. We base our estimates on historical experience, valuations, or various assumptions that are believed to be reasonable under the circumstances. There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2018.2019.

Revenue Recognition:  We recognize revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers,, which we adopted effective January 1, 2018. Accordingly, we recognize revenue when our customers obtain control of its products or services, in an amount that reflects the consideration that we expect to receive in exchange for those goods and services. See Note 2 – Revenue Recognition, included in Part I, Item 1 of this Quarterly Report on Form 10-Q, for additional disclosures.

Accounts ReceivableReceivable:  Our accounts receivable have terms that require payment in 30 days.  We did not establish an allowance for doubtful accounts as of SeptemberJune 30, 20192020 as we have not experiencedhad any write offs or experienced a deterioration in the aging of our receivables, to date and do not expect to experience in the future.

InventoriesInventories:  Inventories consist of finished goods, raw materials and subassemblies and are recorded as the lower of cost or net realizable value using the first-in, first, in-first out method.

Contingent consideration:  In connection with the purchase of the Aquadex Business, we had an obligation to pay additional consideration that was contingent upon the occurrence of certain future events (see Note 9 to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q).  Contingent consideration was recognized at the acquisition date at $126,000, the estimated fair value of the contingent milestone payments.  The fair value of the contingent consideration was remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings.  As of September 30, 2019, this contingency had expired, therefore its fair value was $0.

Stock-Based Compensation: We recognize all share-based payments to employees and directors, including grants of stock options, warrants and common stock awards in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. We expense the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received.  In accordance with Accounting Standards Update 2018-07, unvested awards are no longer remeasured to fair value until vesting and rather the fair value is established at the grant date consistent with the treatment of employee director awards.

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We compute the estimated fair values of stock options and warrants using the Black-Scholes option pricing model and market-based warrants using a Monte Carlo valuation model. Market price at the date of grant is used to calculate the fair value of restricted stock units and common stock awards.

Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures except for market-based warrants which are expensed based on the grant date fair value regardless of whether the award vests. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

Loss per share: We compute basic loss per share based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the ninesix months ended SeptemberJune 30, 2020, reflects a $1.6 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series H Convertible Preferred Stock on January 28, 2020. The net loss allocable to common stockholders for the six months ended June 30, 2019, reflects a $4.5 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the March 2019 public offering, representing the intrinsic value of the preferred shares at the time of issuance.

Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include warrants, stock options and other stock-based awards granted under stock-based compensation plans. These potentially dilutive shares were excluded from the computation of loss per share as their effect was antidilutive due to our net loss in each of those periods.

Going Concern:Our consolidated financial statements have been prepared and presented on a basis assuming we continue as a going concern. During the years ended December 31, 2019 and 2018, and 2017, and through SeptemberJune 30, 2019,2020, we incurred losses from operations and net cash outflows from operating activities as disclosed in the condensed consolidated statements of operations and cash flows, respectively. As of SeptemberJune 30, 2019,2020, we had an accumulated deficit of $213.1$226.0 million and we expect to incur losses for the immediate future. To date, we have been funded primarily by various debt and equity financings, and although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we will ever operate profitably. These factors raise substantial doubt about our ability to continue as a going concern through the next twelve months.

We became a revenue generating company only after acquiring the Aquadex Business in August 2016.  We expect to incur additional losses in the near-term as we grow the Aquadex Business, including investments in expanding our sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company.  To become and remain profitable, we must succeed in expanding the adoption and market acceptance of the Aquadex FlexFlowSmartFlow system. This will require us to succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing and distributing the Aquadex FlexFlowSmartFlow system and related components. There can be no assurance that we will succeed in these activities, and we may never generate revenues sufficient to achieve profitability.

During 2017, 2018, 2019 and through November 6, 2019,May 5, 2020, we closed on registered direct and underwritten public equity offerings for net proceeds of approximately $41.4$30.3 million after deducting the underwriting discounts and commissions and other costs associated with the offering. We will be required to seek additional funding to grow our Aquadex Business,business, which may not be available on terms favorable to us, or at all. We may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions.  Should warrant exercises not materialize or future capital raising be unsuccessful, we may not be able to continue as a going concern. We have made no adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we not continue as a going concern.

NEW ACCOUNTING PRONOUNCEMENTS

Information regarding new accounting pronouncements, when applicable, is included in Note 1 to the condensed consolidated financial statements included in this Quarterly Report.Report on Form 10-Q.  There are no new accounting pronouncements not yet adopted that the Company believes will have a material impact on the financial statements of the Company.

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FINANCIAL OVERVIEW

We are a medical device company focused on developing, manufacturing and commercializing the Aquadex systemSystem for ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy. Activities since inception have consisted principally of raising capital, performing research and development and conducting preclinical and clinical studies. During 2016, we acquired the Aquadex Business and announced that we were halting all clinical evaluations of our prior technology, the C-Pulse System. Since then, our activities have consisted mainly of expanding our sales and marketing capabilities and transferring manufacturing capabilities from Baxter to our facilities in Eden Prairie, Minnesota. As of SeptemberJune 30, 2019,2020, we had an accumulated deficit of $213.1$226.0 million and we expect to incur losses for the immediateforeseeable future. To date, we have been funded by public and private equity financings and debt. Although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we will ever operate profitably.

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Results of Operations

Comparison of Three Months Ended SeptemberJune 30, 20192020 to Three Months Ended SeptemberJune 30, 20182019

Net Sales
(in thousands)

Three Months Ended
September 30, 2019
 
Three Months Ended
September 30, 2018
 Increase (Decrease) % Change 
Three Months Ended
June 30, 2020
Three Months Ended
June 30, 2020
 
Three Months Ended
June 30, 2019
 Increase (Decrease) % Change 
$
1,252
  
$
1,363
  
$
(111
)
  
(8.1
)%
1,863  $1,677  $186   11.1%

Revenue is generated mainly from the sale of disposable blood filters and catheters used in conjunction with the Aquadex FlexFlowsystem consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. We sell outside of the United States to independent specialty distributors who in turn sell to hospitals and clinics in their geographic regions. The decreaseincrease in net sales compared to the same period of 2018 is driven by a reorganizationexecution of our salesforce to best align experiencescommercialization strategy which includes continued expansion of our commercial footprint by the hiring of new sales representatives, clinical education specialists, and competencies with our go-to market strategy around cardiac surgery and eventually pediatrics.marketing personnel.

Costs and Expenses
Our costs and expenses were as follows:

( in thousands) 
Three Months Ended
September 30, 2019
 
Three Months Ended
September 30, 2018
 Increase (Decrease) % Change 
(in thousands) 
Three Months Ended
June 30, 2020
  
Three Months Ended
June 30, 2019
  Increase (Decrease)  % Change 
Cost of goods sold
 
$
540
  
$
915
  
$
(375
)
  
(41.0
)%
 $664  $835  $(171) 20.5%
Selling, general and administrative
 
$
4,107
  
$
3,713
  
$
394
   
10.6
%
 $4,234  $3,973  $261  6.6%
Research and development
 
$
1,112
  
$
985
  
$
127
   
12.9
%
 $885  $1,297  $(412) (31.8)%

Cost of Goods Sold
In connection with the acquisition of the Aquadex Business, we entered into a manufacturing and supply agreement with Baxter. In 2017, we provided notice to Baxter to cease the manufacturing of the Aquadex product line and we began transitioning activities in house. In August 2018, we announced that the transfer of all manufacturing activities was complete.

Cost of sales in 2018 reflects the agreed-upon price paid to Baxter for the manufacturing of the disposables and consoles, as well as startup costs associated with the transfer of manufacturing activities to our facilities in Eden Prairie, Minnesota. In the first quarter of 2019, we began selling our internally manufactured inventory, driving theafter successfully transitioning all manufacturing activities from Baxter during 2018. The improvement in gross margins in the second quarter of 2020, reflects the impact of increasing volumes and efficiencies achieved as we leverage our existing manufacturing infrastructure. While we may experience quarterly variations in gross margins. In future quarters,margin performance, we expect that our yearly gross margins will continue to improve as volumes increase and we achieve larger efficiencies of scale.

Selling, General and Administrative
The increase in selling, general and administrative expense reflect primarily on-going investment in our commercial organization as we continue to expand our outreach in the field with incremental clinical specialists and marketing support. Our general and administrative costs have remained consistent with the prior year.

As we realign and grow our distribution footprint, we We expect that our selling expenses will increase modestly in future quarters as we annualize the impact of recent hires, and that general and administrative expenses will remain consistent to the current quarter.

Research and Development
The increasedecrease in research and development expenses relate to investments we are makingmade to improve the functionality of our Aquadex system, and to support our 510(k) submission for pediatric label modification, and to improve the functionality of our Aquadex system, including console software updates and catheter improvements.which were completed during 2019. We expect that ourfuture research and development expenditures will decrease modestly remain consistent to the current quarter.

Comparison of Six Months Ended June 30, 2020 to Six Months Ended June 30, 2019

Net Sales
(in future quarters.thousands)

Six Months Ended
June 30, 2020
  
Six Months Ended
June 30, 2019
  Increase (Decrease)  % Change 
$3,493  $2,892  $601   20.8%

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Comparison of Nine Months Ended September 30, 2019 to Nine Months Ended September 30, 2018

Net Sales
(dollars in thousands)

Nine Months Ended
September 30, 2019
  
Nine Months Ended
September 30, 2018
  Increase (Decrease)  % Change 
$
4,144
  
$
3,499
  
$
645
   
18.4
%

Revenue is generated mainly from the sale of disposable blood filters and catheters used in conjunction with ourthe Aquadex FlexFlowsystem consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. We sell outside of the United States to independent specialty distributors who in turn sell to hospitals and clinics in their geographic regions. The changeincrease in net sales compared to the same period of 2018 is driven by the execution of our commercialization strategy which includes continued expansion of our commercial footprint by the hiring of new sales representatives, clinical education specialists, and marketing personnel. In the fourth quarter of 2019, we announced a reorganization of our sales force to best align experiences and competencies with our go-to market strategy around cardiac surgery and eventually pediatrics.

Costs and Expenses
Our costs and expenses were as follows:

(dollars in thousands) 
Nine Months Ended
September 30, 2019
 
Nine Months Ended
September 30, 2018
 Increase (Decrease) % Change 
(in thousands) 
Six Months Ended
June 30, 2020
  
Six Months Ended
June 30, 2019
  Increase (Decrease)  % Change 
Cost of goods sold
 
$
1,987
  
$
2,686
  
$
(699
)
  
(26.0
)%
 $1,460  $1,447  $13  0.9%
Selling, general and administrative
 
$
12,098
  
$
11,489
  
$
609
   
5.3
%
 $8,770  $7,991  $779  9.7%
Research and development
 
$
3,719
  
$
2,107
  
$
1,612
   
76.5
%
 $1,749  $2,607  $(858) (32.9)%

Cost of Goods Sold
In connection with the acquisition of the Aquadex Business, we entered into a manufacturing and supply agreement with Baxter. We provided notice to Baxter to cease the manufacturing of the Aquadex product line in 2017, and we began transitioning activities in house. In August 2018, we announced that the transfer of all manufacturing activities was complete.

Cost of sales in 2018 reflects the agreed-upon price paid to Baxter for the manufacturing of the disposables and consoles, as well as startup costs associated with the transfer of manufacturing activities to our facilities in Eden Prairie, Minnesota. In the first quarter of 2019, we began selling our internally manufactured inventory, driving theafter successfully transitioning all manufacturing activities from Baxter during 2018. The improvement in gross margins in the first six months of 2020, reflects the impact of increasing volumes and efficiencies achieved as we leverage our existing manufacturing infrastructure. While we may experience quarterly variations in gross margins. In future quarters,margin performance, we expect that our yearly gross margins will continue to improve as volumes increase and we achieve larger efficiencies of scale.

Selling, General and Administrative
The increase in selling, general and administrative expense reflect primarily on-going investment in our commercial organization as we continue to expand our outreach in the field with incremental sales specialists, clinical specialists and marketing support. Our general and administrative costs have remained consistent towith the prior year.

As we continue to increase our distribution footprint, we We expect that our selling expenses will continue to increase modestly in future quarters as we annualize the impact of recent hires, and that general and administrative expenses will remain consistent to the current quarter.

Research and Development
The increasedecrease in research and development expenses relate to investments we are makingmade to improve the functionality of our Aquadex system, and to support our 510(k) submission for pediatric label modification, and to improve the functionality of our Aquadex system, including console software updates and catheter improvements.which were completed during 2019. We expect that ourfuture research and development expenditures will decrease modestly in future quarters.remain consistent to the current quarter.

Liquidity and Capital Resources

Sources of Liquidity
We have funded our operations primarily through cash on hand and a series of equity and debt issuances.

On July 3, 2018, we closed on an underwritten public offering of 181,941 shares of common stock, for gross proceeds of $5.4 million.  Net proceeds totaled approximately $4.6 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 43 Stockholders’ Equity, to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

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On March 12, 2019, we closed on an underwritten public offering for netnet proceeds totaling approximately $11.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants. In connection with this offering, we issued a total of 455,178 shares of common stock, approximately 1.9 million shares of Series G convertible preferred stock and warrants to purchase approximately 4.7 million shares of common stock. See Note 43 Stockholders’ Equity, to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

On October 25, 2019, we closed on a registered direct offering of common stock, for gross proceeds of approximately $660,000, prior to deducting commissions and expenses related to the transaction.  In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 575,830 shares of our common stock.  See Note 103Subsequent Events,Stockholders’ Equity, to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

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On November 6, 2019, we closed on a registered direct offering of common stock, for gross proceeds of approximately $1.36 million, prior to deducting commissions and expenses related to the transaction.  In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,219,076 shares of our common stock. See Note 3 – Stockholders’ Equity, to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

On August 5, 2016,January 28, 2020, we entered into a loan agreement with Silicon Valley Bankclosed on an underwritten public offering of 6,046,367 shares of common stock, 11,517,269 shares of Series H Preferred Stock and warrants to purchase 17,563,636 shares of Common Stock, which included the full exercise of the underwriter’s over-allotment option, for gross proceeds of approximately $9.7 million. Net proceeds totaled approximately $8.6 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 – Stockholders’ Equity, to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

On March 23, 2020, we closed on a registered direct offering of 4,161,392 shares of common stock at a price to the public of $0.30 per share, for gross proceeds of approximately $1.2 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to $5.04,161,392 shares of the Company’s common stock.  See Note 3 – Stockholders’ Equity, to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

On April 1, 2020 we closed on a registered direct offering of 5,130,228 shares of common stock at a price to the public of $0.434 per share, for gross proceeds of approximately $2.2 million, includingprior to deduction of commissions and offering expenses payable related to the transaction. In a $1.0 million revolving lineconcurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 2,565,114 shares of creditthe Company’s common stock.  The warrants to purchase up to 2,565,114 shares of common stock have an exercise price of $0.3715 per share, are exercisable immediately, and expire five and a $4.0 million term loan. The term loan expired unusedhalf years from the date of issuance. On April 29, 2020, we filed a registration statement to register the shares of common stock issuable upon exercise of the warrants that were issued on November 30, 2016March 23, 2020 and April 1, 2020 and the registration statement was declared effective by the term loan is no longer availableSEC on May 8, 2020.   See Note 3 – Stockholders’ Equity, to be drawn. Under the revolving line,condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

On May 5, 2020, we may borrow the lesserclosed on a registered direct offering of $1 million or 80%3,597,880 shares of our eligible accounts (subject to customary exclusions), minus the outstanding principal balance of any advances under the revolving line.  Advances under the revolving line, if any, will accrue interestcommon stock at a floatingprice to the public of $0.4725 per annum rate equalshare, for gross proceeds of approximately $1.7 million, prior to 1.75% or 1.0% abovededuction of commissions and offering related to the prime rate, dependingtransaction. In a concurrent private placement, we agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,798,940 shares of the Company’s common stock. The warrants have an exercise price of $0.41 per share, are exercisable immediately, and will expire five and a half years from the date of issuance. On May 29, 2020, we filed a registration statement to register the shares of common stock issuable upon exercise of the warrants that were issued on liquidity factors. The loan agreement contains customary representations, as well as customary affirmativein this transaction, and negative covenants. Our obligations underthe registration statement was declared effective by the new loan agreement are secured by a security interestSEC on June 8, 2020.  See Note 3 – Stockholders’ Equity, to the condensed consolidated financial statements included in our assets, excluding intellectual property and certain other exceptions. We are subjectPart I, Item 1 of this Quarterly Report on Form 10-Q.

During the first six months of 2020, investors exercised warrants to a negative pledge covenant with respect to our intellectual property. Advances under the revolving line are subject to various conditions precedent, including our compliance with financial covenants relating to net liquidity relative to monthlyacquire 7,736,275 shares of common stock for cash burn. The revolving line of credit expires on March 31, 2020. We had no borrowings outstanding under the Silicon Valley Bank facility as of September 30, 2019 or December 31, 2018.proceeds totaling $2.3 million.

As of SeptemberJune 30, 2019,2020, and December 31, 2018,2019, cash and cash equivalents were $3.6$7.8 million and $5.5$1.3 million, respectively. Prior to our acquisition of the Aquadex Business in August 2016, we did not have a product approved for commercial sale and focused our resources on developing, manufacturing, and commercializing our C-Pulse System.  Our business strategy and ability to fund our operations in the future depends in part on our ability to grow our Aquadex Business by establishing a sales force, selling our products to hospitals and other healthcare facilities and controlling costs. We believeWhile we expect to continue to receive proceeds from the exercise of warrants, we will likely need to seek additional financing in the future.future, which, to date, has been through offerings of our equity. The disruption created by COVID-19 in our operations, our sales outlook, and the capital markets where we would seek such financing, have created uncertainty about our ability to access the capital markets in future periods.

Cash Flows from Operating Activities
Net cash used in operating activities was $12.3 million$8.8 and $11.8$8.9 million for the ninesix months ended SeptemberJune 30, 20192020 and 2018,2019, respectively. The net cash used in each of these periods primarily reflects the net loss for those periods, offset in part by stock-based compensation, depreciation and amortization, and the effects of changes in operating assets and liabilities.liabilities, mainly the reduction in outstanding payables and accrued expenses, as well as increases in raw materials and finished goods inventory.

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Cash Flows from Investing Activities
Net cash used in investing activities was $464,000$69,000 and $177,000$158,000 for the ninesix months ended SeptemberJune 30, 20192020 and September 30, 2018,2019, respectively.  The majority of cash used in investing activities was primarily for internally manufactured equipment, and the purchase of manufacturing, laboratory and office equipment.

Cash Flows from Financing Activities
As described above, net cash provided by financing activities was $11.0 million$15.4 and $4.6$11.0 million for the ninesix months ended SeptemberJune 30, 20192020 and September 30, 2018,2019, respectively.

Capital Resource Requirements

As of SeptemberJune 30, 2019,2020, we did not have any material commitments for capital expenditures.

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Off-Balance Sheet Arrangements

On August 5, 2016, we entered into an asset purchase agreement for the Aquadex Business with Baxter, whereby we agreed that, if we dispose of any of the acquired assets for a price that exceeds $4.0 million within three years of the closing, we would pay Baxter 40% of the amount of such excess. This commitment expired on August 6, 2019. In addition, we also agreed that, if shares of our common stock cease to be publicly traded on the Nasdaq Capital Market, Baxter has the option to require us to repurchase, in cash, all or any part of the common shares held by Baxter at a price equal to their fair market value, as determined by a third-party appraiser.

Except as disclosed above, weWe have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.resources

Forward-Looking Statements and Risk Factors

Certain statements in this Quarterly Report on Form 10-Q are forward-looking statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), that are based on management’s beliefs, assumptions and expectations and information currently available to management.  All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations regarding the potential impacts of the COVID-19 pandemic on our business operations, cash flow, business development, and employees, our ability to execute on our strategic realignments, 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, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.words. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.  Forward-looking statements are subject to a number of risks and uncertainties that could cause actual events to adversely differ from the expectations indicated in these forward-looking statements, including without limitation, the risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019, and June 30, 2019, this Quarterly Report and in other reports filed thereafter with the SEC, which risk factors we may updateby updated from time to time.time, and in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. We operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties. CHF Solutions may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility that regulatory authorities do not accept our application or approve the marketing of our products, the possibility we may be unable to raise the funds necessary for the development and commercialization of our products, and those described in our filings with the SEC.

.
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4.
CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer (together, the “Certifying“Certifying Officers”), as appropriate, to allow for timely decisions regarding required disclosure.

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In designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired objectives. Also, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. The design of any system of controls is based, in part, upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

As of SeptemberJune 30, 2019,2020, the end of the period covered by this report, we conducted an evaluation, under the supervision and with the participation of management, including the Certifying Officers, of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).Act.  Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their stated objectives.  Based on their evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of SeptemberJune 30, 2019.2020.

Changes in Internal Controls over Financial Reporting

There was no change in our internal control over financial reporting during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

ITEM 1.
LEGAL PROCEEDINGS

We are not currently subject to any material legal proceedings.proceedings, nor, to our knowledge, is any other material litigation threatened against us.

ITEM 1A.
RISK FACTORS

You should carefully consider the risks and uncertainties we describe in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018,2019,our Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in other reports filed thereafter with the SEC, before deciding to invest in or retain shares of our common stock.We do not believe there are any material changes to the risk factors discussed in Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018.

ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

NoneOther than as previously reported on our Current Reports on Form 8-K, there have been no unregistered sales of equity securities for the current reporting period.

ITEM 3.
DEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM 4.
MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5.
OTHER INFORMATION

None.

ITEM 6.
EXHIBITS

The exhibits filed as part of this Quarterly Report on Form 10-Q are listed in the Exhibit Index below.

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Exhibit Index
CHF Solutions, Inc.
Form 10-Q for the Quarterly Period Ended SeptemberJune 30, 20192020

    Incorporated By Reference   
 
Exhibit
Number
 Exhibit Description Form 
File
Number
 Date of First Filing 
Exhibit
Number
 
Filed
Herewith
Furnished Herewith
 Fourth Amended and Restated Certificate of Incorporation 
10
 
 
001-35312
 
 
February 1, 2012
 
 
3.1
 
   
              
 
 Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation 
8-K
 
 
001-35312
 
 January 13, 2017 3.1   
              
 
 Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation 8-K 001-35312 May 23, 2017 3.1   
              
 
 Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation 8-K 001-35312 October 12, 2017 
3.1
 
   
              
 Form of Certificate of Designation of Series A Junior Participating Preferred Stock 8-K 001-35312 June 14, 2013 3.1   
              
 Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock S-1/A 333-221010 November 17, 2017 3.7   
              
 Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation, as amended, of CHF Solutions, Inc 8-K 
001-35312
 
 January 2, 2019 3.1   
              
 Form of Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock S-1/A 333-209102 February 25, 2019 3.9   
              
 Second Amended and Restated Bylaws 8-K
 001-35312
 May 23, 2017
 3.2 

              
10.1
 Non - Employee Director Compensation Policy
         X 
              
 Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002         X 
              
 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002         X 
              
 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002          X
    Incorporated By Reference 
Exhibit
Number
 Exhibit Description Form 
File
Number
 Date of First Filing 
Exhibit
Number
 
Filed
Herewith
Furnished Herewith

Fourth Amended and Restated Certificate of Incorporation
10
001-35312
February 1, 2012
3.1


             
 
 Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
8-K
001-35312
 

January 13, 2017
 

3.1 

              
 
 Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
8-K
 

001-35312
May 23, 2017
3.1


              
 

Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
8-K
 

001-35312
 

October 12, 2017
3.1   
              
 Form of Certificate of Designation of Series A Junior Participating Preferred Stock 8-K 001-35312 June 14, 2013 3.1   
              
 Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock S-1/A 333-221010 November 17, 2017 3.7   
              
 Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation, as amended, of CHF Solutions, Inc 8-K 
001-35312
 
 January 2, 2019 3.1   
              
 Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock 
8-K
 
001-35312
 March 13, 2019 3.1   
              
 Certificate of Designation of Preferences, Rights and Limitations of Series H Convertible Preferred Stock 8-K 001-35312 January 29, 2020 3.1   
              

Second Amended and Restated Bylaws
8-K
001-35312
May 23, 2017 3.2   
              
 Form of common stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated May 1, 2020, among the Company and the purchasers identified on the signature pages thereto 8-K 001-35312 May 4, 2020 4.1   
              
 Placement Agency Agreement, dated as of May 1, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. 8-K 001-35312 May 4, 2020 1.1   

23

    Incorporated By Reference   
 
Exhibit
Number
 Exhibit Description Form 
File
Number
 Date of First Filing 
Exhibit
Number
 
Filed
Herewith
Furnished Herewith
Form of Securities Purchase Agreement, dated as of May 1, 2020, by and among the Company and the purchasers identified on the signature pagers thereto8-K001-35312May 4, 202010.1
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002X
 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002X
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002          X
            ��
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
 
101.INS XBRL Instance Document         X 
              
101.SCH XBRL Taxonomy Extension Schema Document         X 
              
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document         X 
              
101.DEF XBRL Taxonomy Extension Definition Linkbase Document         X 
              
101.LAB XBRL Taxonomy Extension Label Linkbase Document         X 
              
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document         X 

24

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 thereunto duly authorized.


CHF Solutions, Inc.
   
Date: November 8, 2019August 5, 2020By:
/s/ John L. Erb

  
John L. Erb
  Chief Executive Officer and Chairman of the Board
  (principal executive officer)

Date: November 8, 2019August 5, 2020By:/s/ Claudia Drayton
  Claudia Drayton
  Chief Financial Officer

 (principal financial officer)


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