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): May 10, 2022
(Exact Name of Registrant as Specified in its Charter)
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No.
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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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(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:
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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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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 May 10, 2022, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three months ended March 31, 2022. 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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Exhibits
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Exhibit No.
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Description |
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Press Release, dated May 10, 2022, reporting the financial results of Nuwellis, Inc. for the three months ended March 31, 2022.
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| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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: May 10, 2022
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NUWELLIS, INC.
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By:
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/s/ Nestor Jaramillo
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Name:
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Nestor Jaramillo
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Title:
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President and Chief Executive Officer
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Exhibit 99.1
Nuwellis, Inc. Announces First Quarter 2022 Financial Results
Minneapolis, MN, May 10, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) announced today its results for the first quarter ended March 31, 2022, which included the
following highlights:
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Generated $1.9 million in total revenue for the first quarter 2022, up 17% sequentially from the fourth quarter of 2021
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Received a Category III CPT Code effective January 1, 2022, specifically for the use of therapeutic ultrafiltration, thereby increasing reimbursement to professionals and facilities, an important step in advancing Aquadex to standard
of care
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On track to enroll first patients in REVERSE-HF, a randomized controlled multi-center clinical trial designed to validate clinical outcomes and the economic value of Aquadex therapy
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First quarter 2022 cash flow from operations improved $0.6 million compared to the prior-year period
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“I am very pleased with the resilient performance in the quarter” said Nestor Jaramillo, CEO of Nuwellis. “Going forward, we expect to continue
benefiting from the successful execution of our strategy and rollout of our new sales management system.”
First Quarter 2022 Financial Results
Total revenue for the first quarter of 2022 was $1.9 million, an increase of 17% compared to the fourth quarter of 2021 and even with the prior-year
period. Growth in the quarter was fueled by higher sales of consumables. Capital equipment sales increased sequentially but were below the prior year, while total monthly year-on-year sales comparisons improved as the business advanced through the
quarter.
Gross margin was 57.2% for the first quarter 2022, compared to 50.4% in the prior-year period, with the increase driven primarily by favorable
product sales mix and reduced inventory revaluation expense.
Selling, general and administrative expenses for the first quarter of
2022 were $4.4 million, representing a 16% reduction compared to the prior-year period. This reduction resulted from continued cost vigilance and certain non-recurring administrative costs in the prior-year period.
First-quarter research and development expenses were $1.1 million dollars, compared to $0.9 million dollars in the first quarter of 2021. This
increase reflects investment in our dedicated pediatric device.
The net loss for the first quarter of 2022 was $4.5 million, compared to a net loss of $5.2 million in the prior-year period. This resulted in $0.6
million lower net cash used in operating activities.
Cash and cash equivalents were approximately $19.3 million as of March 31, 2022.
Webcast and Conference Call Information
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.nuwellis.com. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.)
or (224) 357-2194 (international) and using conference ID: 6092276. An audio archive of the webcast will be available following the call at http://ir.nuwellis.com.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming 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. Nuwellis is headquartered in Minneapolis, MN, with a wholly owned
subsidiary in Ireland.
About the Aquadex SmartFlow System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow
system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid
overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
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 2022 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 risks associated
with our ability to execute on our commercialization strategy, the impact of the COVID-19 pandemic, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection
activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product
offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with
the SEC. Forward-looking statements speak only as of the date when made. Nuwellis 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.
NUWELLIS, INC. AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)
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Three months ended
March 31,
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2022
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2021
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Net sales
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$
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1,926
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$
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1,918
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Cost of goods sold
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824
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952
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Gross profit
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1,102
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966
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Operating expenses:
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Selling, general and administrative
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4,412
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5,237
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Research and development
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1,106
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947
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Total operating expenses
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5,518
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6,184
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Loss from operations
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(4,416
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(5,218
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Other income (expense), net
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(55
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(1
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Loss before income taxes
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(4,471
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(5,219
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Income tax expense
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(2
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(2
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Net loss
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$
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(4,473
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$
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(5,221
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Basic and diluted loss per share
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$
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(0.42
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$
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(1.62
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Weighted average shares outstanding – basic and diluted
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10,538
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3,242
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Other comprehensive loss:
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Unrealized foreign currency translation adjustments
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$
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(2
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$
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(3
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Total comprehensive loss
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$
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(4,475
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$
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(5,224
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NUWELLIS, INC. AND SUBSIDIARY
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
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March 31,
2022
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December 31, 2021
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ASSETS
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(unaudited)
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Current assets
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Cash and cash equivalents
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$
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19,300
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$
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24,205
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Accounts receivable
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951
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750
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Inventories
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3,294
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2,843
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Other current assets
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350
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328
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Total current assets
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23,895
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28,126
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Property, plant and equipment, net
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1,153
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1,188
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Operating lease right-of-use asset
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1,038
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1,082
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Other assets
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21
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21
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TOTAL ASSETS
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$
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26,107
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$
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30,417
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current liabilities
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Accounts payable
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$
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1,797
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$
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1,414
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Accrued compensation
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1,335
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1,664
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Current portion of operating lease liability
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181
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167
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Current portion of finance lease liability
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24
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26
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Other current liabilities
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55
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36
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Total current liabilities
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3,392
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3,307
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Operating lease liability
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909
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956
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Finance lease liability
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22
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28
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Other long-term liability
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71
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179
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Total liabilities
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4,394
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4,470
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Commitments and contingencies
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Stockholders’ equity
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Series A junior participating preferred stock as of March 31, 2022 and December 31, 2021, 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 March 31, 2022 and December 31, 2021, par value $0.0001 per share; authorized 127 shares, issued and
outstanding 127 shares
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—
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—
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Preferred stock as of both March 31, 2022 and December 31, 2021, par value
$0.0001 per share; authorized 39,969,873 shares, none outstanding
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—
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—
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Common stock as of March 31, 2022 and December 31, 2021, par value
$0.0001 per share; authorized 100,000,000 shares, issued and outstanding
10,537,606 shares
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1
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1
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Additional paid-in capital
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279,114
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278,873
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Accumulated other comprehensive income:
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Foreign currency translation adjustment
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(13
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(11
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Accumulated deficit
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(257,389
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)
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(252,916
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)
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Total stockholders’ equity
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21,713
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25,947
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
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$
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26,107
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$
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30,417
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NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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Three months ended
March 31,
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2022
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2021
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Operating Activities:
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Net loss
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$
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(4,473
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)
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$
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(5,221
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)
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Adjustments to reconcile net loss to cash flows used in operating activities:
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Depreciation and amortization
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105
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126
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Stock-based compensation expense, net
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241
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355
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Changes in operating assets and liabilities:
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Accounts receivable
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(201
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)
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(14
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)
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Inventory
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(451
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)
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(89
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)
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Other current assets
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(22
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)
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(132
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)
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Other assets and liabilities
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(80
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)
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24
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Accounts payable and accrued expenses
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54
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(431
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)
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Net cash used in operating activities
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(4,827
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)
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(5,382
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)
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Investing Activities:
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Purchases of property and equipment
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(70
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)
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(56
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Net cash used in investing activities
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(70
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)
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(56
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)
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Financing Activities:
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Proceeds from public stock offerings, net
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—
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18,902
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Proceeds from warrant exercises
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—
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1
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Payments on finance lease liability
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(6
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)
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(6
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)
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Net cash provided (used in) by financing activities
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(6
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)
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18,897
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Effect of exchange rate changes on cash
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(2
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)
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(3
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)
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Net increase in cash and cash equivalents
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(4,905
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)
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13,456
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Cash and cash equivalents - beginning of period
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24,205
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14,437
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Cash and cash equivalents - end of period
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$
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19,300
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$
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27,893
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Supplemental cash flow information
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Inventory transferred to property, plant and equipment
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$
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—
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$
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89
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# # #
INVESTOR CONTACTS:
George Montague, CFA
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Matt Bacso, CFA
Gilmartin Group
Matt.Bacso@gilmartinir.com