|
|
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 August 9, 2022, reporting the financial results of Nuwellis, Inc. for the three and six months ended June 30, 2022.
|
Date: August 9, 2022
|
NUWELLIS, INC.
|
||
By:
|
/s/ Nestor Jaramillo, Jr.
|
||
Name:
|
Nestor Jaramillo, Jr.
|
||
Title:
|
President and Chief Executive Officer
|
|
• |
Generated $2.2 million in total revenue for the second quarter 2022, up 15% sequentially from the first quarter of 2022,
|
• |
Enrolled first patient in REVERSE-HF, a randomized controlled multi-center clinical trial designed to validate clinical outcomes and the economic value of Aquadex therapy, and
|
• |
Decreased operating expenses 14% compared to the second quarter of 2021 to minimize cash utilization while continuing to fund key strategic initiatives.
|
• |
Webcast link for interested listeners:
|
o |
https://edge.media-server.com/mmc/p/frxpm437
|
• |
Dial-in registration for sell-side research analysts:
|
o |
https://register.vevent.com/register/BIea28b3e149034b04b99b65da059db74a
|
June 30,
2022
|
December 31,
2021
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
15,345
|
$
|
24,205
|
||||
Accounts receivable
|
1,313
|
750
|
||||||
Inventories
|
3,010
|
2,843
|
||||||
Other current assets
|
252
|
328
|
||||||
Total current assets
|
19,920
|
28,126
|
||||||
Property, plant and equipment, net
|
1,063
|
1,188
|
||||||
Operating lease right-of-use asset
|
994
|
1,082
|
||||||
Other assets
|
21
|
21
|
||||||
TOTAL ASSETS
|
$
|
21,998
|
$
|
30,417
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$
|
1,550
|
$
|
1,414
|
||||
Accrued compensation
|
1,633
|
1,664
|
||||||
Current portion of operating lease liability
|
186
|
167
|
||||||
Current portion of finance lease liability
|
27
|
26
|
||||||
Other current liabilities
|
63
|
36
|
||||||
Total current liabilities
|
3,459
|
3,307
|
||||||
Operating lease liability
|
860
|
956
|
||||||
Finance lease liability
|
15
|
28
|
||||||
Other long-term liability
|
—
|
179
|
||||||
Total liabilities
|
4,334
|
4,470
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity
|
||||||||
Series A junior participating preferred stock as of June 30, 2022 and December 31, 2021, par value $0.0001 per share;
authorized 30,000 shares, none outstanding
|
—
|
—
|
||||||
Series F convertible preferred stock as of both June 30, 2022 and December 31, 2021, par value $0.0001 per share;
authorized 127 shares, issued and outstanding 127 shares
|
—
|
—
|
||||||
Preferred stock as of both June 30, 2022 and December 31, 2021, par value $0.0001 per share;
authorized 39,969,873 shares, none outstanding
|
—
|
—
|
||||||
Common stock as of June 30, 2022 and December 31, 2021, par value $0.0001 per share; authorized
100,000,000 shares, issued and outstanding 10,537,606 shares
|
1
|
1
|
||||||
Additional paid-in capital
|
279,350
|
278,873
|
||||||
Accumulated other comprehensive income:
|
||||||||
Foreign currency translation adjustment
|
(12
|
)
|
(11
|
)
|
||||
Accumulated deficit
|
(261,675
|
)
|
(252,916
|
)
|
||||
Total stockholders’ equity
|
17,664
|
25,947
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
21,998
|
$
|
30,417
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
Net sales
|
$
|
2,213
|
$
|
2,508
|
$
|
4,139
|
$
|
4,426
|
||||||||
Cost of goods sold
|
1,150
|
997
|
1,974
|
1,949
|
||||||||||||
Gross profit
|
1,063
|
1,511
|
2,165
|
2,477
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Selling, general and administrative
|
4,257
|
5,063
|
8,669
|
10,300
|
||||||||||||
Research and development
|
1,107
|
1,174
|
2,213
|
2,121
|
||||||||||||
Total operating expenses
|
5,364
|
6,237
|
10,882
|
12,421
|
||||||||||||
Loss from operations
|
(4,301
|
)
|
(4,726
|
)
|
(8,717
|
)
|
(9,944
|
)
|
||||||||
Other income (expense), net
|
17
|
(2
|
)
|
(38
|
)
|
(3
|
)
|
|||||||||
Loss before income taxes
|
(4,284
|
)
|
(4,728
|
)
|
(8,755
|
)
|
(9,947
|
)
|
||||||||
Income tax expense
|
(2
|
)
|
(3
|
)
|
(4
|
)
|
(5
|
)
|
||||||||
Net loss
|
$
|
(4,286
|
)
|
$
|
(4,731
|
)
|
$
|
(8,759
|
)
|
$
|
(9,952
|
)
|
||||
Basic and diluted loss per share
|
$
|
(0.41
|
)
|
$
|
(0.72
|
)
|
$
|
(0.83
|
)
|
$
|
(2.04
|
)
|
||||
Weighted average shares outstanding – basic and diluted
|
10,538
|
6,532
|
10,538
|
4,887
|
||||||||||||
Other comprehensive loss:
|
||||||||||||||||
Foreign currency translation adjustments
|
$
|
1
|
$
|
—
|
$
|
(1
|
)
|
$
|
(3
|
)
|
||||||
Total comprehensive loss
|
$
|
(4,285
|
)
|
$
|
(4,731
|
)
|
$
|
(8,760
|
)
|
$
|
(9,955
|
)
|
Six months ended
June 30,
|
||||||||
2022
|
2021
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(8,759
|
)
|
$
|
(9,952
|
)
|
||
Adjustments to reconcile net loss to cash flows used in operating activities:
|
||||||||
Depreciation and amortization
|
206
|
256
|
||||||
Stock-based compensation expense, net
|
477
|
736
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(563
|
)
|
(272
|
)
|
||||
Inventory
|
(167
|
)
|
122
|
|||||
Other current assets
|
76
|
(176
|
)
|
|||||
Other assets and liabilities
|
(152
|
)
|
9
|
|||||
Accounts payable and accrued expenses
|
117
|
75
|
||||||
Net cash used in operating activities
|
(8,765
|
)
|
(9,202
|
)
|
||||
Investing Activities:
|
||||||||
Purchases of property and equipment
|
(81
|
)
|
(137
|
)
|
||||
Net cash used in investing activities
|
(81
|
)
|
(137
|
)
|
||||
Financing Activities:
|
||||||||
Proceeds from public stock offerings, net
|
—
|
18,896
|
||||||
Proceeds from warrant exercises
|
—
|
1
|
||||||
Payments on finance lease liability
|
(13
|
)
|
(14
|
)
|
||||
Net cash provided (used in) by financing activities
|
(13
|
)
|
18,883
|
|||||
Effect of exchange rate changes on cash
|
(1
|
)
|
(3
|
)
|
||||
Net increase (decrease) in cash and cash equivalents
|
(8,860
|
)
|
9,541
|
|||||
Cash and cash equivalents - beginning of period
|
24,205
|
14,437
|
||||||
Cash and cash equivalents - end of period
|
$
|
15,345
|
$
|
23,978
|
||||
Supplemental cash flow information
|
||||||||
Inventory transferred to property, plant and equipment
|
$
|
—
|
$
|
179
|