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Share Name | Share Symbol | Market | Type |
---|---|---|---|
CHF Solutions Inc | NASDAQ:CHFS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 5.28 | 5.10 | 5.32 | 0 | 01:00:00 |
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended September 30, 2022
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
No. 68-0533453
|
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.0001 per share
|
NUWE
|
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|
Non-accelerated Filer ☒
|
Smaller reporting company ☒
|
|
Emerging growth company ☐
|
Page Number
|
||
PART I—FINANCIAL INFORMATION
|
||
Item 1
|
3 |
|
3
|
||
4
|
||
5
|
||
6
|
||
7
|
||
Item 2
|
13 | |
Item 3
|
21
|
|
Item 4
|
21 | |
PART II—OTHER INFORMATION
|
||
Item 1
|
22 | |
Item 1A
|
22 | |
Item 2
|
23 |
|
Item 3
|
23 | |
Item 4
|
23 | |
Item 5
|
23 | |
Item 6
|
23 |
September 30,
2022
|
December 31,
2021
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
12,053
|
$
|
24,205
|
||||
Accounts receivable
|
1,100
|
750
|
||||||
Inventories
|
2,919
|
2,843
|
||||||
Other current assets
|
368
|
328
|
||||||
Total current assets
|
16,440
|
28,126
|
||||||
Property, plant and equipment, net
|
1,027
|
1,188
|
||||||
Operating lease right-of-use asset
|
949
|
1,082
|
||||||
Other assets
|
21
|
21
|
||||||
TOTAL ASSETS
|
$
|
18,437
|
$
|
30,417
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$
|
1,561
|
$
|
1,414
|
||||
Accrued compensation
|
1,751
|
1,664
|
||||||
Current portion of operating lease liability
|
191
|
167
|
||||||
Current portion of finance lease liability
|
35
|
26
|
||||||
Other current liabilities
|
73
|
36
|
||||||
Total current liabilities
|
3,611
|
3,307
|
||||||
Operating lease liability
|
810
|
956
|
||||||
Finance lease liability
|
— |
28
|
||||||
Other long-term liability
|
— | 179 | ||||||
Total liabilities
|
4,421
|
4,470
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity
|
||||||||
Series A junior participating preferred stock as of September 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 September 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 September 30, 2022 and December 31, 2021, par value $0.0001 per
share; authorized 39,969,873 shares, none outstanding
|
—
|
—
|
||||||
Common stock as of September 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
|
279,570
|
278,873
|
||||||
Accumulated other comprehensive income:
|
||||||||
Foreign currency translation adjustment
|
(10
|
)
|
(11
|
)
|
||||
Accumulated deficit
|
(265,545
|
)
|
(252,916
|
)
|
||||
Total stockholders’ equity
|
14,016
|
25,947
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
18,437
|
$
|
30,417
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2022
|
2021
|
2022 | 2021 | |||||||||||||
Net sales
|
$
|
2,065
|
$
|
1,853
|
$ | 6,204 | $ | 6,279 | ||||||||
Cost of goods sold
|
806
|
733
|
2,780 | 2,682 | ||||||||||||
Gross profit
|
1,259
|
1,120
|
3,424 | 3,597 | ||||||||||||
Operating expenses:
|
||||||||||||||||
Selling, general and administrative
|
4,251
|
4,645
|
12,920 | 14,945 | ||||||||||||
Research and development
|
928
|
1,726
|
3,141 | 3,847 | ||||||||||||
Total operating expenses
|
5,179
|
6,371
|
16,061 | 18,792 | ||||||||||||
Loss from operations
|
(3,920
|
)
|
(5,251
|
)
|
(12,637 | ) | (15,195 | ) | ||||||||
Other income (expense), net
|
52
|
(19
|
)
|
14 | (22 | ) | ||||||||||
Loss before income taxes
|
(3,868
|
)
|
(5,270
|
)
|
(12,623 | ) | (15,217 | ) | ||||||||
Income tax expense
|
(2
|
)
|
(2
|
)
|
(6 | ) | (7 | ) | ||||||||
Net loss
|
$
|
(3,870
|
)
|
$
|
(5,272
|
)
|
$ | (12,629 | ) | $ | (15,224 | ) | ||||
Basic and diluted loss per share
|
$
|
(0.37
|
)
|
$
|
(0.75
|
)
|
$ | (1.20 | ) | $ | (2.72 | ) | ||||
Weighted average shares outstanding – basic and diluted
|
10,538
|
7,098
|
10,538 | 5,624 | ||||||||||||
Other comprehensive loss:
|
||||||||||||||||
Foreign currency translation adjustments
|
$
|
2
|
$
|
—
|
$ | 1 | $ | (3 | ) | |||||||
Total comprehensive loss
|
$
|
(3,868
|
)
|
$
|
(5,272
|
)
|
$ | (12,628 | ) | $ | (15,227 | ) |
Outstanding
Shares of
Common Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2020
|
2,736,060
|
$
|
—
|
$
|
249,663
|
$
|
(7
|
)
|
$
|
(233,338
|
)
|
$
|
16,318
|
|||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(5,221
|
)
|
(5,221
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(3
|
)
|
—
|
(3
|
)
|
||||||||||||||||
Stock-based compensation, net
|
—
|
—
|
355
|
—
|
—
|
355
|
||||||||||||||||||
Issuance of common, net
|
3,795,816
|
—
|
18,902
|
—
|
—
|
18,902
|
||||||||||||||||||
Exercise of warrants
|
66
|
—
|
1
|
—
|
—
|
1
|
||||||||||||||||||
Balance March 31, 2021
|
6,531,942
|
$
|
—
|
$
|
268,921
|
$
|
(10
|
)
|
$
|
(238,559
|
)
|
$
|
30,352
|
|||||||||||
Net loss
|
— |
— | — | — | (4,731 | ) | (4,731 | ) | ||||||||||||||||
Foreign currency translation adjustment
|
— |
— | — | — | — | — | ||||||||||||||||||
Stock-based compensation, net
|
— | — | 381 | — | — | 381 | ||||||||||||||||||
Issuance costs related to common stock offering
|
— | — | (6 | ) | — | — | (6 | ) | ||||||||||||||||
Exercise of warrants
|
76 | — | — | — | — | — | ||||||||||||||||||
Balance June 30, 2021
|
6,532,018 | $ | — | $ | 269,296 | $ | (10 | ) | $ | (243,290 | ) | $ | 25,996 | |||||||||||
Net loss
|
— | — | — | — | (5,272 | ) | (5,272 | ) | ||||||||||||||||
Foreign currency translation adjustment
|
— | — | — | — | — | — | ||||||||||||||||||
Stock-based compensation, net
|
— | — | 257 | — | — | 257 | ||||||||||||||||||
Issuance of common stock, net
|
4,005,588 | 1 | 8,999 | — | — | 9,000 | ||||||||||||||||||
Balance September 30, 2021
|
10,537,606 | $ |
1 | $ |
278,552 | $ |
(10 | ) | $ |
(248,562 | ) | $ |
29,981 |
Outstanding
Shares of
Common Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Loss
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2021
|
10,537,606
|
$
|
1
|
$
|
278,873
|
$
|
(11
|
)
|
$
|
(252,916
|
)
|
$
|
25,947
|
|||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(4,473
|
)
|
(4,473
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(2
|
)
|
—
|
(2
|
)
|
||||||||||||||||
Stock-based compensation, net
|
—
|
—
|
241
|
—
|
—
|
241
|
||||||||||||||||||
Balance March 31, 2022
|
10,537,606
|
$
|
1
|
$
|
279,114
|
$
|
(13
|
)
|
$
|
(257,389
|
)
|
$
|
21,713
|
|||||||||||
Net loss
|
— |
— | — | — | (4,286 | ) | (4,286 | ) | ||||||||||||||||
Foreign currency translation adjustment
|
— |
— | — | 1 | — | 1 | ||||||||||||||||||
Stock-based compensation, net
|
— | — | 236 | — | — | 236 | ||||||||||||||||||
Balance June 30, 2022
|
10,537,606 | $ | 1 | $ | 279,350 | $ | (12 | ) | $ | (261,675 | ) | $ | 17,664 | |||||||||||
Net loss
|
— | — | — | — | (3,870 | ) | (3,870 | ) | ||||||||||||||||
Foreign currency translation adjustment
|
— | — | — | 2 | — | 2 | ||||||||||||||||||
Stock-based compensation, net
|
— | — | 220 | — | — | 220 | ||||||||||||||||||
Balance September 30, 2022
|
10,537,606 | $ |
1 | $ |
279,570 | $ |
(10 | ) | $ |
(265,545 | ) | $ |
14,016 |
Nine months ended
September 30,
|
||||||||
2022
|
2021
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(12,629
|
)
|
$
|
(15,224
|
)
|
||
Adjustments to reconcile net loss to cash flows used in operating activities:
|
||||||||
Depreciation and amortization
|
301
|
383
|
||||||
Stock-based compensation expense, net
|
697
|
993
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(350
|
)
|
(164
|
)
|
||||
Inventory
|
(113
|
)
|
(105
|
)
|
||||
Other current assets
|
(40
|
)
|
(183
|
)
|
||||
Other assets and liabilities
|
(142
|
)
|
279
|
|||||
Accounts payable and accrued expenses
|
254
|
333
|
||||||
Net cash used in operating activities
|
(12,022
|
)
|
(13,688
|
)
|
||||
Investing Activities:
|
||||||||
Purchases of property and equipment
|
(103
|
)
|
(191
|
)
|
||||
Net cash used in investing activities
|
(103
|
)
|
(191
|
)
|
||||
Financing Activities:
|
||||||||
Proceeds from public stock offerings, net
|
—
|
27,896
|
||||||
Proceeds from warrant exercises
|
—
|
1
|
||||||
Payments on finance lease liability
|
(28
|
)
|
(21
|
)
|
||||
Net cash (used in) provided by financing activities
|
(28
|
)
|
27,876
|
|||||
Effect of exchange rate changes on cash
|
1
|
(3
|
)
|
|||||
Net increase (decrease) in cash and cash equivalents
|
(12,152
|
)
|
13,994
|
|||||
Cash and cash equivalents - beginning of period
|
24,205
|
14,437
|
||||||
Cash and cash equivalents - end of period
|
$
|
12,053
|
$
|
28,431
|
||||
Supplemental cash flow information
|
||||||||
Inventory transferred to property, plant and equipment
|
$
|
37
|
$
|
257
|
(in thousands)
|
September 30,
2022
|
December 31, 2021
|
||||||
Finished Goods
|
$
|
1,180
|
$
|
1,409
|
||||
Work in Process
|
223
|
276
|
||||||
Raw Materials
|
1,516
|
1,158
|
||||||
Total
|
$
|
2,919
|
$
|
2,843
|
September 30,
|
||||||||
2022
|
2021
|
|||||||
Stock options
|
1,200,259
|
738,946
|
||||||
Warrants to purchase common stock
|
1,630,627
|
1,631,801
|
||||||
Series F convertible preferred stock
|
50,800
|
50,800
|
||||||
Total
|
2,881,686
|
2,421,547
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
(in thousands, except per share amounts)
|
||||||||||||||||
Net loss
|
$
|
(3,870
|
)
|
$
|
(5,272
|
)
|
$
|
(12,629
|
)
|
$
|
(15,224
|
)
|
||||
Deemed dividend to preferred shareholders (see note 3)
|
—
|
—
|
—
|
(75
|
)
|
|||||||||||
Net loss after deemed dividend
|
(3,870
|
)
|
(5,272
|
)
|
(12,629
|
)
|
(15,299
|
)
|
||||||||
Weighted average shares outstanding
|
10,538
|
7,098
|
10,538
|
5,624
|
||||||||||||
Basic and diluted loss per share
|
$
|
(0.37
|
)
|
$
|
(0.75
|
)
|
$
|
(1.20
|
)
|
$
|
(2.72
|
)
|
Three months ended
September 30,
|
Nine
months ended
September 30,
|
|||||||||||||||
(in thousands)
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
Selling, general and administrative expense
|
$
|
199
|
$
|
216
|
$
|
624
|
$
|
894
|
||||||||
Research and development expense
|
21
|
40
|
73
|
99
|
||||||||||||
Total stock-based compensation expense
|
$
|
220
|
$
|
256
|
$
|
697
|
$
|
993
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended
September 30, 2022
|
Three Months Ended
September 30, 2021
|
Increase (Decrease)
|
% Change
|
|||||||||||
$
|
2,065
|
$
|
1,853
|
$
|
212
|
11.4
|
%
|
(in thousands)
|
Three Months Ended
September 30, 2022
|
Three Months Ended
September 30, 2021
|
Increase (Decrease)
|
% Change
|
||||||||||||
Cost of goods sold
|
$
|
806
|
$
|
733
|
$
|
73
|
10.0
|
%
|
||||||||
Selling, general and administrative
|
$
|
4,251
|
$
|
4,645
|
$
|
(394
|
)
|
(8.5
|
)%
|
|||||||
Research and development
|
$
|
928
|
$
|
1,726
|
$
|
(798
|
)
|
(46.2
|
)%
|
Nine Months Ended
September 30, 2022
|
Nine Months Ended
September 30, 2021
|
Increase (Decrease)
|
% Change
|
|||||||||||
$
|
6,204
|
$
|
6,279
|
$
|
(75
|
)
|
(1.2
|
)%
|
(in thousands)
|
Nine Months Ended
September 30, 2022
|
Nine Months Ended
September 30, 2021
|
Increase (Decrease)
|
% Change
|
||||||||||||
Cost of goods sold
|
$
|
2,780
|
$
|
2,682
|
$
|
98
|
3.7
|
%
|
||||||||
Selling, general and administrative
|
$
|
12,920
|
$
|
14,945
|
$
|
(2,025
|
)
|
(13.5
|
)%
|
|||||||
Research and development
|
$
|
3,141
|
$
|
3,847
|
$
|
(706
|
)
|
(18.3
|
)%
|
ITEM 1. |
LEGAL PROCEEDINGS
|
ITEM 1A. |
RISK FACTORS
|
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4. |
MINE SAFETY DISCLOSURES
|
ITEM 5. |
OTHER INFORMATION
|
ITEM 6. |
EXHIBITS
|
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
|
|||||||||
Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation
|
8-K/A
|
001-35312
|
October 16, 2020
|
3.1
|
||||||||||
Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
January 2, 2019
|
3.1
|
||||||||||
Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
April 27, 2021
|
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 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
|
||||||||||
Certificate of Designation of Preferences, Rights and Limitations of Series I Convertible Preferred Stock.
|
8-K
|
001-35312
|
October 18, 2022
|
3.1
|
||||||||||
Second Amended and Restated Bylaws
|
8-K
|
001-35312
|
April 27, 2021
|
3.2
|
Incorporated By Reference
|
||||||||||||||
Exhibit
Number
|
Exhibit Description
|
Form
|
File
Number
|
Date of First Filing
|
Exhibit
Number
|
Filed
Herewith
|
Furnished
Herewith
|
|||||||
Amendment to Second Amended and Restated Bylaws
|
8-K
|
001-35312
|
October 5, 2022
|
3.1
|
||||||||||
Form of Warrant to Purchase Shares of Common Stock
|
S-1/A
|
333-267368
|
October 13, 2022
|
4.20
|
||||||||||
Offer Letter by and between Nuwellis, Inc. and Lynn Blake, effective as of October 24, 2022
|
8-K
|
001-35312
|
October 5, 2022
|
10.1
|
||||||||||
Underwriting Agreement dated as of October 14, 2022, by and between Nuwellis, Inc. and Ladenburg Thalmann & Co. Inc.
|
8-K
|
001-35312
|
October 18, 2022
|
1.1
|
||||||||||
Warrant Agency Agreement
|
8-K
|
001-35312
|
October 18, 2022
|
4.2
|
||||||||||
Leak-Out Agreement
|
S-1/A
|
333-267368
|
September 30, 2022
|
10.70
|
||||||||||
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
|
|||||||||||||
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
|||||||||||||
101.INS
|
Inline XBRL Instance Document
|
X
|
||||||||||||
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
X
|
||||||||||||
101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
X
|
||||||||||||
101.DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
X
|
||||||||||||
101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
X
|
||||||||||||
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
X
|
||||||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
X
|
Nuwellis, Inc.
|
||
Date: November 8, 2022
|
By:
|
/s/ Nestor Jaramillo, Jr.
|
Nestor Jaramillo, Jr.
|
||
Chief Executive Officer
|
||
Date: November 8, 2022
|
By:
|
/s/ Lynn L. Blake
|
Lynn L. Blake
|
||
Chief Financial Officer
|
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