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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Newellis Inc | NASDAQ:NUWE | 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% | 4.23 | 4.12 | 4.80 | 6 | 09:13:47 |
|
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the quarterly period ended June 30, 2021
|
|
☐
|
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
|
Nasdaq Capital Market
|
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
|
20
|
|
Item 4
|
20
|
|
PART II—OTHER INFORMATION
|
||
Item 1
|
20
|
|
Item 1A
|
20
|
|
Item 2
|
20
|
|
Item 3
|
20
|
|
Item 4
|
21
|
|
Item 5
|
21
|
|
Item 6
|
21
|
June 30,
2021
|
December 31,
2020
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
23,978
|
$
|
14,437
|
||||
Accounts receivable
|
1,177
|
905
|
||||||
Inventories
|
2,656
|
2,957
|
||||||
Other current assets
|
413
|
237
|
||||||
Total current assets
|
28,224
|
18,536
|
||||||
Property, plant and equipment, net
|
1,260
|
1,200
|
||||||
Operating lease right-of-use asset
|
156
|
255
|
||||||
Other assets
|
—
|
21
|
||||||
TOTAL ASSETS
|
$
|
29,640
|
$
|
20,012
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$
|
1,787
|
$
|
1,097
|
||||
Accrued compensation
|
1,577
|
2,192
|
||||||
Current portion of operating lease liability
|
160
|
206
|
||||||
Current portion of finance lease liability
|
25
|
24
|
||||||
Other current liabilities
|
54
|
66
|
||||||
Total current liabilities
|
3,603
|
3,585
|
||||||
Operating lease liability
|
—
|
55
|
||||||
Finance lease liability
|
41
|
54
|
||||||
Total liabilities
|
3,644
|
3,694
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity
|
||||||||
Series A junior participating preferred stock as of June 30,
2021 and December 31,
2020, par value $0.0001
per share; authorized 30,000 shares, none outstanding
|
—
|
—
|
||||||
Series F convertible preferred stock as of both June 30,
2021 and December 31,
2020, par value $0.0001
per share; authorized 127 shares, issued and outstanding 127 shares
|
—
|
—
|
||||||
Preferred stock as of both June 30, 2021 and December 31, 2020, par value $0.0001 per
share; authorized 39,969,873 shares, none outstanding
|
—
|
—
|
||||||
Common stock as of June 30, 2021 and December 31, 2020, par value $0.0001 per
share; authorized 100,000,000 shares, issued and outstanding 6,532,018 and 2,736,060, respectively
|
—
|
—
|
||||||
Additional paid‑in capital
|
269,296
|
249,663
|
||||||
Accumulated other comprehensive loss:
|
||||||||
Foreign currency translation adjustment
|
(10
|
)
|
(7
|
)
|
||||
Accumulated deficit
|
(243,290
|
)
|
(233,338
|
)
|
||||
Total stockholders’ equity
|
25,996
|
16,318
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
29,640
|
$
|
20,012
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
2021
|
2020
|
2021 | 2020 | |||||||||||||
Net sales
|
$
|
2,508
|
$
|
1,863
|
$ | 4,426 | $ | 3,493 | ||||||||
Cost of goods sold
|
997
|
664
|
1,949 | 1,460 | ||||||||||||
Gross profit
|
1,511
|
1,199
|
2,477 | 2,033 | ||||||||||||
Operating expenses:
|
||||||||||||||||
Selling, general and administrative
|
5,063
|
4,234
|
10,300 | 8,770 | ||||||||||||
Research and development
|
1,174
|
885
|
2,121 | 1,749 | ||||||||||||
Total operating expenses
|
6,237
|
5,119
|
12,421 | 10,519 | ||||||||||||
Loss from operations
|
(4,726
|
)
|
(3,920
|
)
|
(9,944 | ) | (8,486 | ) | ||||||||
Other income (expense), net
|
(2
|
)
|
—
|
(3 | ) | — | ||||||||||
Loss before income taxes
|
(4,728
|
)
|
(3,920
|
)
|
(9,947 | ) | (8,486 | ) | ||||||||
Income tax expense
|
(3
|
)
|
(2
|
)
|
(5 | ) | (4 | ) | ||||||||
Net loss
|
$
|
(4,731
|
)
|
$
|
(3,922
|
)
|
$ | (9,952 | ) | $ | (8,490 | ) | ||||
Basic and diluted loss per share
|
$
|
(0.72
|
)
|
$
|
(3.10
|
)
|
$ | (2.04 | ) | $ | (11.31 | ) | ||||
Weighted average shares outstanding – basic and diluted
|
6,532
|
1,264
|
4,887 | 906 | ||||||||||||
Other comprehensive loss:
|
||||||||||||||||
Foreign currency translation adjustments
|
$
|
—
|
$
|
(2
|
)
|
$ | (3 | ) | $ | (5 | ) | |||||
Total comprehensive loss
|
$
|
(4,731
|
)
|
$
|
(3,924
|
)
|
$ | (9,955 | ) | $ | (8,495 | ) |
Outstanding
Shares of Common Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2019
|
155,802
|
$
|
—
|
$
|
218,278
|
$
|
1,214
|
$
|
(217,502
|
)
|
$
|
1,990
|
||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(4,568
|
)
|
(4,568
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(3
|
)
|
—
|
(3
|
)
|
||||||||||||||||
Stock-based compensation, net
|
—
|
—
|
380
|
—
|
—
|
380
|
||||||||||||||||||
Issuance of common and preferred stock, net
|
340,261
|
—
|
9,616
|
—
|
—
|
9,616
|
||||||||||||||||||
Exercise of warrants
|
29,933
|
—
|
289
|
—
|
—
|
289
|
||||||||||||||||||
Conversion of preferred stock into common stock
|
378,751
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||
Balance March 31, 2020
|
904,747
|
$
|
—
|
$
|
228,563
|
$
|
1,211
|
$
|
(222,070
|
)
|
$
|
7,704
|
||||||||||||
Net loss |
—
|
— | — | — | (3,922 | ) | (3,922 | ) | ||||||||||||||||
Foreign currency translation adjustment
|
—
|
— | — | (2 | ) | — | (2 | ) | ||||||||||||||||
Stock-based compensation, net
|
— | — | 347 | — | — | 347 | ||||||||||||||||||
Issuance of common stock, net
|
290,938 | — | 3,424 | — | — | 3,424 | ||||||||||||||||||
Exercise of warrants | 227,939 | — | 2,051 | — | — | 2,051 | ||||||||||||||||||
Conversion of preferred stock into common stock
|
16,270 | — | — | — | — | — | ||||||||||||||||||
Balance June 30, 2020
|
1,439,894 | $ | — | $ | 234,385 | $ | 1,209 | $ | (225,992 | ) | $ | 9,602 |
Outstanding
Shares of Common Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Loss
|
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 stock, 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 offerings
|
— | — | (6 | ) | — | — | (6 | ) | ||||||||||||||||
Exercise of warrants | 76 | — | — | — | — | — | ||||||||||||||||||
Balance June 30, 2021
|
6,532,018 | $ | — | $ | 269,296 | $ | (10 | ) | $ | (243,290 | ) | $ | 25,996 |
Six months ended
June 30,
|
||||||||
2021
|
2020
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(9,952
|
)
|
$
|
(8,490
|
)
|
||
Adjustments to reconcile net loss to cash flows used in operating activities:
|
||||||||
Depreciation and amortization
|
256
|
151
|
||||||
Stock-based compensation expense, net
|
736
|
727
|
||||||
Loss on disposal of property and equipment
|
—
|
46
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(272
|
)
|
(179
|
)
|
||||
Inventory
|
122
|
(1,104
|
)
|
|||||
Other current assets
|
(176
|
)
|
20
|
|||||
Other assets and liabilities
|
9
|
112
|
||||||
Accounts payable and accrued expenses
|
75
|
(43
|
)
|
|||||
Net cash used in operating activities
|
(9,202
|
)
|
(8,760
|
)
|
||||
Investing Activities:
|
||||||||
Purchases of property and equipment
|
(137
|
)
|
(69
|
)
|
||||
Net cash used in investing activities
|
(137
|
)
|
(69
|
)
|
||||
Financing Activities:
|
||||||||
Proceeds from public stock offerings, net
|
18,896
|
13,040
|
||||||
Proceeds from warrant exercises
|
1
|
2,340
|
||||||
Payments on finance lease liability
|
(14
|
)
|
(4
|
)
|
||||
Net cash provided by financing activities
|
18,883
|
15,376
|
||||||
Effect of exchange rate changes on cash
|
(3
|
)
|
(5
|
)
|
||||
Net increase in cash and cash equivalents
|
9,541
|
6,542
|
||||||
Cash and cash equivalents - beginning of period
|
14,437
|
1,279
|
||||||
Cash and cash equivalents - end of period
|
$
|
23,978
|
$
|
7,821
|
||||
Supplemental cash flow information
|
||||||||
Inventory transferred to property, plant and equipment
|
$
|
179
|
$
|
112
|
||||
Equipment acquired through finance lease liability
|
$ | — | $ | 67 |
( in thousands)
|
June 30,
2021
|
December 31, 2020
|
||||||
Finished Goods
|
$
|
1,304
|
$
|
1,343
|
||||
Work in Process
|
199
|
342
|
||||||
Raw Materials
|
1,153
|
1,272
|
||||||
Total
|
$
|
2,656
|
$
|
2,957
|
June 30
|
||||||||
2021
|
2020
|
|||||||
Warrants to purchase common stock
|
1,631,806
|
764,525
|
||||||
Series F convertible preferred stock
|
23,114
|
48,720
|
||||||
Stock options
|
812,561
|
17,534
|
||||||
Total
|
2,467,481
|
830,779
|
(in thousands, except per share amounts)
|
2021
|
2020
|
||||||
Net loss
|
$
|
(9,952
|
)
|
$
|
(8,490
|
)
|
||
Deemed dividend to preferred shareholders (see Note 3)
|
(33
|
)
|
(1,757
|
)
|
||||
Net loss after deemed dividend
|
(9,985
|
)
|
(10,247
|
)
|
||||
Weighted average shares outstanding
|
4,887
|
906
|
||||||
Basic and diluted loss per share
|
$
|
(2.04
|
)
|
$
|
(11.31
|
)
|
Three months ended
June 30,
|
Six
months ended
June 30,
|
|||||||||||||||
(in thousands)
|
2021
|
2020
|
2021
|
2020
|
||||||||||||
Selling, general and administrative expense
|
$
|
350
|
$
|
321
|
$
|
677
|
$
|
675
|
||||||||
Research and development expense
|
31
|
26
|
59
|
52
|
||||||||||||
Total stock-based compensation expense
|
$
|
381
|
$
|
347
|
$
|
736
|
$
|
727
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended
June 30, 2021
|
Three Months Ended
June 30, 2020 |
Increase (Decrease)
|
% Change
|
|||||||||||
$
|
1,918
|
$
|
1,863
|
$
|
645
|
34.6
|
%
|
(in thousands)
|
Three Months Ended
June 30, 2021
|
Three Months Ended
June 30, 2020
|
Increase (Decrease)
|
% Change
|
||||||||||||||||
Cost of goods sold
|
$
|
997
|
$
|
664
|
$
|
333
|
50.
|
2
|
%
|
|||||||||||
Selling, general and administrative
|
$
|
5,063
|
$
|
4,234
|
$
|
829
|
19.
|
6
|
%
|
|||||||||||
Research and development
|
$
|
1,174
|
$
|
885
|
$
|
289
|
32.
|
7
|
%
|
Six Months Ended
June 30, 2021
|
Six Months Ended
June 30, 2020
|
Increase (Decrease)
|
% Change
|
|||||||||||
$
|
4,426
|
$
|
3,493
|
$
|
933
|
26.7
|
%
|
(in thousands)
|
Six Months Ended
June 30, 2021
|
Six Months Ended
June 30, 2020
|
Increase (Decrease)
|
% Change
|
||||||||||||
Cost of goods sold
|
$
|
1,949
|
$
|
1,460
|
$
|
489
|
33.5
|
%
|
||||||||
Selling, general and administrative
|
$
|
10,300
|
$
|
8,770
|
$
|
1,530
|
17.4
|
%
|
||||||||
Research and development
|
$
|
2,121
|
$
|
1,749
|
$
|
372
|
21.3
|
%
|
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 4. |
CONTROLS AND PROCEDURES
|
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
|
||||||||||
Certificate of Designations of Series A Junior Participating Preferred Stock
|
8-K
|
001-35312
|
June 14, 2013
|
3.1
|
||||||||||
Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock
|
S-1/A
|
333-221010
|
November 6, 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
|
||||||||||
|
Second Amended and Restated Bylaws
|
|
8-K
|
|
001-35312
|
|
April 27, 2021
|
3.2
|
||||||
|
Nuwellis, Inc. 2021 Inducement Plan
|
|
8-K
|
001-35312
|
|
May 20, 2021
|
|
10.1
|
Incorporated By Reference | ||||||||||||||
Exhibit
Number
|
Exhibit Description | Form |
File
Number
|
Date of First Filing |
Exhibit
Number
|
Filed
Herewith
|
|
Furnished
Herewith
|
||||||
Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Nuwellis, Inc. 2021 Inducement Plan
|
8-K
|
001-35312
|
May 20, 2021
|
10.2
|
||||||||||
Offer Letter by and between Nuwellis, Inc. and George Montague, effective as of June 28, 2021
|
8-K
|
001-35312
|
June 22, 2021
|
10.1
|
||||||||||
Offer Letter by and between Nuwellis, Inc. and Neil P. Ayotte, effective as of June 7, 2021.
|
X
|
|||||||||||||
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: August 12, 2021
|
By:
|
/s/ Nestor Jaramillo, Jr.
|
|
Nestor Jaramillo, Jr.
|
|||
President, Chief Executive Officer
(principal executive officer)
|
Date: August 12, 2021
|
By:
|
/s/ George Montague
|
|
George Montague
|
|||
Chief Financial Officer
(principal financial officer)
|
1 Year Newellis Chart |
1 Month Newellis Chart |
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