NUWE 8-K
Nuwellis, Inc. (NUWE)
8-K
2020-03-03
For: 2020-03-03
View Original
Added on
April 10, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 3, 2020
CHF Solutions, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-35312
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No. 68-0533453
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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12988 Valley View Road, Eden Prairie, MN 55344
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(Address of Principal Executive Offices) (Zip Code)
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(952) 345-4200
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(Registrant’s Telephone Number, Including Area Code)
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share
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CHFS
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Nasdaq Capital Market
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to
Section 13(a) of the Exchange Act. ☐
| Item 2.02 |
Results of Operations and Financial Condition.
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On March 3, 2020, CHF Solutions, Inc. issued a press release reporting its financial results for the quarter and year ended December 31, 2019. A copy of the press release is attached hereto as Exhibit
99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 2.02 and shall not be deemed
to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
| Item 9.01 |
Financial Statements and Exhibits.
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| (d) |
Exhibits
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| Exhibit No. |
Description
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| 99.1 |
Press Release, dated March 3, 2020, reporting the financial results of CHF Solutions, Inc. for the quarter and year ended December 31, 2019
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: March 3, 2020
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CHF SOLUTIONS, INC.
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By:
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/s/ Claudia Drayton
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Name:
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Claudia Drayton
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Title:
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Chief Financial Officer
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Exhibit 99.1
CHF Solutions, Inc. Announces Fourth Quarter Financial Results and Provides Company Update
Eden Prairie, MN: March 3, 2020: (GLOBE NEWSWIRE) CHF Solutions, Inc. (Nasdaq: CHFS) announced today its results for the fourth quarter and year ended December 31, 2019, which included the following highlights:
| • |
Received 510(k) clearance in the U.S. and CE Mark in the EU for adult and pediatric patients who weigh 20 kg or more and for the next generation Aquadex console, which will be sold as Aquadex SmartFlow™.
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| • |
Announced expansion of commercial presence in Europe with distribution arrangement for Germany, Austria and Switzerland.
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| • |
Announced presentation of clinical data from an investigator-initiated analysis at the American Society of Kidney Week highlighting the efficacy and simplicity of use of Aquadex FlexFlow in treating patients in critical care settings
such as cardiogenic shock, anasarca, ATN with fluid overload, ESRD with bridge ultrafiltration between hemodialysis treatment, and post-operative fluid overload.
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| • |
Completed sales force realignment to increase focus on cardiac surgery and eventually pediatrics. Revenue for fourth quarter ended December 31, 2019 was $1.4 million, a decrease of 8.8 percent from Q4 2018. For the year 2019, revenue
totaled $5.5 million, a 10 percent increase from 2018.
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| • |
Ended the year with $1.3 million in cash and no debt. Subsequent to quarter end, announced the closing of an underwritten public offering for net proceeds
of approximately $8.6 million, for total pro forma cash balance of $9.9 million.
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“I look back at 2019 as a very successful year for the company,” said John Erb, chairman and CEO of CHF Solutions. “We made important strides in our commercialization efforts, including focusing on new market opportunities and driving important
product improvements which we believe will deliver additional growth in 2020 and beyond.”
The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on the Company’s performance. To access the live webcast, please visit http://ir.chf-solutions.com/events. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID: 7489468. An audio archive of the webcast will be available
following the call at http://ir.chf-solutions.com/events..
About CHF Solutions
CHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on developing, manufacturing, and
commercializing the Aquadex SmartFlow system for ultrafiltration therapy. CHF Solutions is a Delaware corporation headquartered in Minneapolis, Minnesota with wholly owned subsidiaries in Australia and Ireland. The company has been listed on the
Nasdaq Capital Market since February 2012.
About the Aquadex SmartFlow System
The Aquadex SmartFlow system is a clinically proven therapy that provide a safe, effective, and predictable method of removing excess fluid from patients suffering from fluid overload. The Aquadex SmartFlow system is
indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management,
including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
Forward-Looking Statements
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth
in 2020 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could
cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our ability to execute on our commercialization strategy, the possibility that we may be
unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization
efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated
synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly
update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
# # #
FINANCIALS
CHF SOLUTIONS, INC. AND SUBSIDIARIES
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Three months ended
December 31
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Year ended
December 31,
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|||||||||||||||
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2019
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2018
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2019
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2018
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|||||||||||||
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Net sales
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$
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1,367
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$
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1,499
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$
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5,511
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$
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4,998
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||||||||
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Costs and Expenses:
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||||||||||||||||
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Cost of goods sold
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673
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984
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2,660
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3,670
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||||||||||||
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Selling, general and administrative
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4,187
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3,822
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16,285
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15,311
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||||||||||||
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Research and development
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953
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946
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4,672
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3,053
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||||||||||||
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Total costs and expenses
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5,813
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5,752
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23,617
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22,034
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||||||||||||
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Loss from operations
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(4,446
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)
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(4,253
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)
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(18,106
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)
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(17,036
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)
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||||||||
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Other income, net
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1
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—
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—
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10
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||||||||||||
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Loss before income taxes
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(4,445
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)
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(4,253
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)
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(18,106
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)
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(17,026
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)
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||||||||
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Income tax expense
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(3
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)
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(3
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)
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(8
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)
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(6
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)
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||||||||
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Net loss
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$
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(4,448
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)
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$
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(4,256
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)
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$
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(18,114
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)
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$
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(17,032
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)
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Basic and diluted loss per share
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$
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(1.12
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)
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$
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(8.37
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)
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$
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(9.30
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)
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$
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(42.14
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)
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Weighted average shares outstanding – basic and diluted
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3,988
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509
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2,433
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404
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||||||||||||
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Other comprehensive loss:
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||||||||||||||||
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Foreign currency translation adjustment
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$
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(5
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)
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$
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(2
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)
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$
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(9
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)
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$
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(4
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)
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||||
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Total comprehensive loss
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$
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(4,453
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)
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$
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(4,258
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)
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$
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(18,123
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)
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$
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(17,036
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)
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||||
CHF SOLUTIONS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
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December 31,
2019
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December 31,
2018
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|||||||
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ASSETS
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||||||||
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Current assets
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||||||||
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Cash and cash equivalents
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$
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1,279
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$
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5,480
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||||
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Accounts receivable
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799
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786
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||||||
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Inventories
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1,797
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1,658
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||||||
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Other current assets
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161
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203
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||||||
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Total current assets
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4,036
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8,127
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||||||
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Property, plant and equipment, net
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991
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536
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||||||
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Operating lease right-of-use asset, net
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442
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—
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||||||
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Other assets
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133
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113
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||||||
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TOTAL ASSETS
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$
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5,602
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$
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8,776
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||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||||||
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Current liabilities
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||||||||
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Accounts payable
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$
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1,488
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$
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1,133
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Accrued compensation
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1,592
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1,498
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Current portion of operating lease liability
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186
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—
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||||||
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Other current liabilities
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85
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209
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||||||
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Total current liabilities
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3,351
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2,840
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||||||
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Operating lease liability
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261
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—
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||||||
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Total liabilities
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3,612
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2,840
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||||||
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Commitments and contingencies
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||||||||
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Stockholders’ equity
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||||||||
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Series A junior participating preferred stock as of December 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 30,000 shares, none outstanding
|
—
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—
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||||||
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Series F convertible preferred stock as of both December 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 535 shares, issued and outstanding 535 shares
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—
|
—
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||||||
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—
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—
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|||||||
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—
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—
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|||||||
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Additional paid‑in capital
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218,278
|
204,101
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||||||
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Accumulated other comprehensive income:
|
||||||||
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Foreign currency translation adjustment
|
1,214
|
1,223
|
||||||
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Accumulated deficit
|
(217,502
|
)
|
(199,388
|
)
|
||||
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Total stockholders’ equity
|
1,990
|
5,936
|
||||||
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
5,602
|
$
|
8,776
|
||||
CHF SOLUTIONS, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
|
For the years ended December 31,
|
||||||||
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2019
|
2018
|
|||||||
|
Operating Activities
|
||||||||
|
Net loss
|
$
|
(18,114
|
)
|
$
|
(17,032
|
)
|
||
|
Adjustments to reconcile net loss to cash flows from operating activities:
|
||||||||
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Depreciation and amortization
|
239
|
232
|
||||||
|
Stock-based compensation expense
|
1,512
|
2,087
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable
|
(13
|
)
|
(241
|
)
|
||||
|
Inventories
|
(343
|
)
|
(70
|
)
|
||||
|
Other current assets
|
42
|
(67
|
)
|
|||||
|
Other assets and liabilities
|
18
|
(14
|
)
|
|||||
|
Accounts payable and accrued expenses
|
292
|
545
|
||||||
|
Net cash used in operations
|
(16,367
|
)
|
(14,560
|
)
|
||||
|
Investing activities:
|
||||||||
|
Purchase of property and equipment
|
(490
|
)
|
(198
|
)
|
||||
|
Net cash used in investing activities
|
(490
|
)
|
(198
|
)
|
||||
|
Financing activities:
|
||||||||
|
Net proceeds from public stock offerings, net
|
12,665
|
4,647
|
||||||
|
Net cash provided by financing activities
|
12,665
|
4,647
|
||||||
|
Effect of exchange rate changes on cash
|
(9
|
)
|
(4
|
)
|
||||
|
Net decrease in cash and cash equivalents
|
(4,201
|
)
|
(10,115
|
)
|
||||
|
Cash and cash equivalents—beginning of year
|
5,480
|
15,595
|
||||||
|
Cash and cash equivalents—end of year
|
$
|
1,279
|
$
|
5,480
|
||||
|
Supplemental schedule of non-cash activities
|
||||||||
|
Financing fees incurred for subsequent equity financing included in other assets and accounts payable
|
$
|
111
|
$
|
78
|
||||
|
Inventory transferred to property, plant and equipment
|
$
|
204
|
$
|
—
|
||||
|
|
||||||||
|
Supplemental cash flow information
|
||||||||
|
Cash paid for income taxes
|
$
|
4
|
$
|
2
|
||||
CONTACTS:
INVESTORS:
Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.
952-345-4205
-or-
Bret Shapiro
Managing Partner
CORE IR
516-222-2560
www.coreir.com