|
|
No.
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Item 2.02 |
Results of Operations and Financial Condition.
|
Item 9.01 |
Financial Statements and Exhibits.
|
(d) | Exhibits |
Press Release, dated November 7, 2023, reporting the financial results of Nuwellis, Inc. for the three and nine months ended September 30, 2023.
|
Date: November 7, 2023
|
NUWELLIS, INC.
|
||
By:
|
/s/ Nestor Jaramillo, Jr.
|
||
Name:
|
Nestor Jaramillo, Jr.
|
||
Title:
|
President and Chief Executive Officer
|
|
• |
Revenue of $2.4 million for the third quarter 2023, increased 16% over the prior quarter and increased 17% over the prior-year period.
|
• |
Therapy utilization, or the number of circuits per placed console, increased 26% over the prior year, reflecting continued increases in the number of patients treated with the Aquadex® therapy.
|
• |
By customer category, third quarter 2023 revenue in Heart Failure increased 27% over the same period last year, Critical Care and Pediatrics increased 16% and 9%, respectively.
|
• |
Despite continuing hospital capital budget constraints, our installed console base increased. In the third quarter, we sold 20 consoles, an increase of 11 units vs prior quarter.
|
September 30,
2023
|
December 31,
2022
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
4,930
|
$
|
17,737
|
||||
Marketable securities
|
—
|
569
|
||||||
Accounts receivable
|
1,425
|
1,406
|
||||||
Inventories, net
|
2,336
|
2,661
|
||||||
Other current assets
|
947
|
396
|
||||||
Total current assets
|
9,638
|
22,769
|
||||||
Property, plant and equipment, net
|
912
|
980
|
||||||
Operating lease right-of-use asset
|
762
|
903
|
||||||
Other assets
|
120
|
21
|
||||||
TOTAL ASSETS
|
$
|
11,432
|
$
|
24,673
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable and accrued liabilities
|
$
|
1,707
|
$
|
2,245
|
||||
Accrued compensation
|
1,021
|
2,161
|
||||||
Current portion of operating lease liability
|
211
|
196
|
||||||
Current portion of finance lease liability
|
8
|
28
|
||||||
Other current liabilities
|
45
|
58
|
||||||
Total current liabilities
|
2,992
|
4,688
|
||||||
Common stock warrant liability
|
—
|
6,868
|
||||||
Operating lease liability
|
601
|
760
|
||||||
Total liabilities
|
3,593
|
12,316
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity
|
||||||||
Series A junior participating preferred stock as of September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 30,000 shares, none outstanding
|
—
|
—
|
||||||
Series F convertible preferred stock as of both September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127
shares
|
—
|
—
|
||||||
Series I convertible preferred stock as of September 30, 2023 and December 31, 2022, par value $0.0001; authorized 1,049,280, issued and outstanding none and 1,049,280,
respectively
|
||||||||
Preferred stock as of both September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 39,969,873 shares, none outstanding
|
—
|
—
|
||||||
Common stock as of September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,864,265 and 536,394 shares,
respectively
|
—
|
—
|
||||||
Additional paid-in capital
|
289,980
|
279,736
|
||||||
Accumulated other comprehensive income:
|
||||||||
Foreign currency translation adjustment
|
(24
|
)
|
(18
|
)
|
||||
Unrealized gain on marketable securities
|
—
|
56 |
||||||
Accumulated deficit
|
(282,117
|
) |
(267,417
|
)
|
||||
Total stockholders’ equity
|
7,839
|
12,357
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ |
11,432
|
$ |
24,673
|
Three months ended
September 30
|
Nine months ended
September 30
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Net sales
|
$
|
2,412
|
$
|
2,065
|
$
|
6,313
|
$
|
6,204
|
||||||||
Cost of goods sold
|
1,031
|
806
|
2,718
|
2,780
|
||||||||||||
Gross profit
|
1,381
|
1,259
|
3,595
|
3,424
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Selling, general and administrative
|
3,428
|
4,251
|
13,582
|
12,920
|
||||||||||||
Research and development
|
1,117
|
928
|
4,050
|
3,141
|
||||||||||||
Total operating expenses
|
4,545
|
5,179
|
17,632
|
16,061
|
||||||||||||
Loss from operations
|
(3,164
|
)
|
(3,920
|
)
|
(14,037
|
)
|
(12,637
|
)
|
||||||||
Other income (expense), net
|
(204
|
)
|
52
|
98
|
14
|
|||||||||||
Change in fair value of warrant liability
|
—
|
—
|
(755
|
)
|
—
|
|||||||||||
Loss before income taxes
|
(3,368
|
)
|
(3,868
|
)
|
(14,694
|
)
|
(12,623
|
)
|
||||||||
Income tax expense
|
(2
|
)
|
(2
|
)
|
(6
|
)
|
(6
|
)
|
||||||||
Net loss
|
$
|
(3,370
|
)
|
$
|
(3,870
|
)
|
$
|
(14,700
|
)
|
$
|
(12,629
|
)
|
||||
Basic and diluted loss per share
|
$
|
(1.81
|
)
|
$
|
(36.72
|
)
|
$
|
(10.21
|
)
|
$
|
(119.85
|
)
|
||||
Weighted average shares outstanding – basic and diluted
|
1,864
|
105
|
1,439
|
105
|
||||||||||||
Other comprehensive loss:
|
||||||||||||||||
Foreign currency translation adjustments
|
$
|
—
|
$
|
2
|
$
|
(6
|
)
|
$
|
1
|
|||||||
Total comprehensive loss
|
$
|
(3,370
|
)
|
$
|
(3,868
|
)
|
$
|
(14,706
|
)
|
$
|
(12,628
|
)
|
Nine months ended
September 30
|
||||||||
2023
|
2022
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(14,700
|
)
|
$
|
(12,629
|
)
|
||
Adjustments to reconcile net loss to cash flows used in operating activities:
|
||||||||
Depreciation and amortization
|
253
|
301
|
||||||
Stock-based compensation expense, net
|
513
|
697
|
||||||
Change in fair value of warrant liability
|
755
|
—
|
||||||
Net realized gain on marketable securities
|
(65
|
)
|
—
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(19
|
)
|
(350
|
)
|
||||
Inventory, net
|
325 |
(113
|
)
|
|||||
Other current assets
|
(551
|
)
|
(40
|
)
|
||||
Other assets and liabilities
|
(16
|
)
|
(142
|
)
|
||||
Accounts payable and accrued expenses
|
(1,678
|
)
|
254
|
|||||
Net cash used in operating activities
|
(15,183
|
)
|
(12,022
|
)
|
||||
Investing Activities:
|
||||||||
Proceeds from sale of marketable securities
|
578
|
—
|
||||||
Additions to intangible assets
|
(99
|
)
|
—
|
|||||
Purchases of property and equipment
|
(185
|
)
|
(103
|
)
|
||||
Net cash provided by (used in) investing activities
|
294
|
(103
|
)
|
|||||
Financing Activities:
|
||||||||
Proceeds from ATM stock offerings, net
|
2,108
|
—
|
||||||
Payments on finance lease liability
|
(20
|
)
|
(28)
|
|||||
Net cash provided by (used in) financing activities
|
2,088
|
(28
|
)
|
|||||
Effect of exchange rate changes on cash
|
(6
|
)
|
1
|
|||||
Net decrease in cash and cash equivalents
|
(12,807
|
)
|
(12,152
|
)
|
||||
Cash and cash equivalents - beginning of period
|
17,737
|
24,205
|
||||||
Cash and cash equivalents - end of period
|
$
|
4,930
|
$
|
12,053
|
||||
Supplemental cash flow information | |
|||||||
Inventory transferred to property, plant and equipment | $ | — | $ | 37 |
||||
Non-cash impact of conversion of warrants to common stock (see Note 3) | $ | 6,868 |
$ | — |
Document and Entity Information |
Nov. 07, 2023 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Nov. 07, 2023 |
Entity File Number | 001-35312 |
Entity Registrant Name | Nuwellis, Inc. |
Entity Central Index Key | 0001506492 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 68-0533453 |
Entity Address, Address Line One | 12988 Valley View Road |
Entity Address, City or Town | Eden Prairie |
Entity Address, State or Province | MN |
Entity Address, Postal Zip Code | 55344 |
City Area Code | 952 |
Local Phone Number | 345-4200 |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.0001 per share |
Trading Symbol | NUWE |
Security Exchange Name | NASDAQ |
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