UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form
10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM _________
to __________
COMMISSION FILE NUMBER 001-41364
TENON MEDICAL,
INC.
(Exact name of registrant as specified in its charter)
Delaware | | 45-5574718 |
(State or other jurisdiction of
incorporation
or organization) | | (I.R.S. Employer
Identification No.) |
| | |
104 Cooper Court Los Gatos, CA 95032 | | (408) 649-5760 |
(Address of principal executive offices) (Zip Code) | | (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value $0.001 per share | | TNON | | The Nasdaq Stock Market LLC |
Warrants to purchase shares of Common Stock, par value $0.001 per share | | TNONW | | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | 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. ☐
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act) Yes ☐ No ☒
As of August 11, 2023, the registrant had a total of 22,612,856 shares
of its common stock, par value $0.001 per share, issued and outstanding.
INDEX
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
This Quarterly Report on
Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995,
Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements largely on our current expectations
and projections about future events and financial trends impacting the financial condition of our business. Forward-looking statements
should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those
statements are made and/or management’s good faith belief as of that time with respect to future events and are subject to risks
and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements.
Forward-looking statements
include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,”
“will,” “should,” “could,” “would,” “expect,” “intend,” “seek,”
“plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,”
“potential,” “might,” “forecast,” “continue,” or the negative of those terms, and similar
expressions and comparable terminology intended to reference future periods. Forward-looking statements include, but are not limited to,
statements about:
| ● | Our ability to effectively
operate our business segments; |
| ● | Our ability to manage our research,
development, expansion, growth and operating expenses; |
| ● | Our ability to evaluate and
measure our business, prospects and performance metrics; |
| ● | Our ability and our national
distributor’s ability to compete, directly and indirectly, and succeed in the highly competitive medical devices industry; |
| ● | Our ability to respond and
adapt to changes in technology and customer behavior; |
| ● | Our ability to protect our
intellectual property and to develop, maintain and enhance a strong brand; and |
Should one or more of these
risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from
those anticipated, believed, estimated, expected, intended or planned.
Factors or events that could
cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee
future results, levels of activity, performance or achievements. Accordingly, the forward-looking statements in this Quarterly Report
on Form 10-Q should not be regarded as representations that the results or conditions described in such statements will occur or that
our objectives and plans will be achieved, and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking
statements.
PART I – FINANCIAL INFORMATION
ITEM 1. Condensed Consolidated Financial Statements
Tenon Medical, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share data)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 5,852 | | |
$ | 2,129 | |
Short-term investments | |
| 493 | | |
| 6,441 | |
Accounts receivable | |
| 601 | | |
| 228 | |
Inventory | |
| 570 | | |
| 415 | |
Prepaid expenses | |
| 413 | | |
| 134 | |
Total current assets | |
| 7,929 | | |
| 9,347 | |
Fixed assets, net | |
| 945 | | |
| 793 | |
Deposits | |
| 51 | | |
| 51 | |
Operating lease right-of-use asset | |
| 762 | | |
| 873 | |
Deferred offering costs | |
| 168 | | |
| 25 | |
TOTAL ASSETS | |
$ | 9,855 | | |
$ | 11,089 | |
| |
| | | |
| | |
Liabilities and Stockholders’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 912 | | |
$ | 550 | |
Accrued expenses | |
| 1,130 | | |
| 717 | |
Current portion of accrued commissions | |
| 1,418 | | |
| 1,035 | |
Current portion of operating lease liability | |
| 242 | | |
| 228 | |
Warrant liability | |
| 3,164 | | |
| — | |
Total current liabilities | |
| 6,866 | | |
| 2,530 | |
Accrued commissions, net of current portion | |
| 1,526 | | |
| 1,624 | |
Operating lease liability, net of current portion | |
| 560 | | |
| 683 | |
Total liabilities | |
| 8,952 | | |
| 4,837 | |
| |
| | | |
| | |
Commitments and contingencies (Note 8) | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, $0.001 par value; 130,000,000 shares authorized at June 30, 2023 and December 31, 2022; 21,623,769 and 11,236,801 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | |
| 22 | | |
| 11 | |
Additional paid-in capital | |
| 49,560 | | |
| 45,833 | |
Accumulated deficit | |
| (48,607 | ) | |
| (39,492 | ) |
Accumulated other comprehensive loss | |
| (72 | ) | |
| (100 | ) |
Total stockholders’ equity | |
| 903 | | |
| 6,252 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 9,855 | | |
$ | 11,089 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
Tenon Medical, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except per share data)
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
$ | 743 | | |
$ | 135 | | |
$ | 1,176 | | |
$ | 206 | |
Cost of sales | |
| 549 | | |
| 271 | | |
| 1,029 | | |
| 546 | |
Gross (Loss) Profit | |
| 194 | | |
| (136 | ) | |
| 147 | | |
| (340 | ) |
| |
| | | |
| | | |
| | | |
| | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 901 | | |
| 657 | | |
| 1,735 | | |
| 1,219 | |
Sales and marketing | |
| 1,883 | | |
| 1,943 | | |
| 3,909 | | |
| 2,219 | |
General and administrative | |
| 1,732 | | |
| 2,720 | | |
| 3,711 | | |
| 3,757 | |
Total Operating Expenses | |
| 4,516 | | |
| 5,320 | | |
| 9,355 | | |
| 7,195 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from Operations | |
| (4,322 | ) | |
| (5,456 | ) | |
| (9,208 | ) | |
| (7,535 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense) | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 37 | | |
| 35 | | |
| 93 | | |
| 36 | |
Interest expense | |
| — | | |
| (88 | ) | |
| — | | |
| (362 | ) |
Other income (expense), net | |
| — | | |
| 21 | | |
| — | | |
| 20 | |
Total Other Income (Expense), net | |
| 37 | | |
| (32 | ) | |
| 93 | | |
| (306 | ) |
Net Loss | |
$ | (4,285 | ) | |
$ | (5,488 | ) | |
$ | (9,115 | ) | |
$ | (7,841 | ) |
Net Loss Per Share of Common Stock | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | (0.33 | ) | |
$ | (0.65 | ) | |
$ | (0.75 | ) | |
$ | (1.66 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-Average Shares of Common Stock Outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 13,051 | | |
| 8,422 | | |
| 12,151 | | |
| 4,726 | |
| |
| | | |
| | | |
| | | |
| | |
Consolidated Statements of Comprehensive Loss: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (4,285 | ) | |
$ | (5,488 | ) | |
$ | (9,115 | ) | |
$ | (7,841 | ) |
Unrealized gain (loss) on investments | |
| 3 | | |
| (27 | ) | |
| 16 | | |
| (27 | ) |
Foreign currency translation adjustment | |
| 13 | | |
| (21 | ) | |
| 12 | | |
| (21 | ) |
Total comprehensive loss | |
$ | (4,269 | ) | |
$ | (5,536 | ) | |
$ | (9,087 | ) | |
$ | (7,889 | ) |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
Tenon Medical, Inc.
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(Unaudited)
(In thousands, except share data)
Three Months Ended June 30, 2023 and 2022:
| |
Series A Convertible Preferred Stock | | |
Series B Convertible Preferred Stock | | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Total | |
Balance at March 31, 2023 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 11,251,299 | | |
$ | 11 | | |
$ | 46,873 | | |
$ | (44,322 | ) | |
$ | (88 | ) | |
$ | 2,474 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,054 | | |
| — | | |
| — | | |
| 1,054 | |
Release of restricted stock units | |
| — | | |
| — | | |
| — | | |
| — | | |
| 372,470 | | |
| 1 | | |
| (1 | ) | |
| — | | |
| — | | |
| — | |
Issuance of common stock and warrants, net of issuance costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| 10,000,000 | | |
| 10 | | |
| 1,634 | | |
| — | | |
| — | | |
| 1,644 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 16 | | |
| 16 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,285 | ) | |
| — | | |
| (4,285 | ) |
Balance at June 30, 2023 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 21,623,769 | | |
$ | 22 | | |
$ | 49,560 | | |
$ | (48,607 | ) | |
$ | (72 | ) | |
$ | 903 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2022 | |
| 2,550,763 | | |
$ | 12,367 | | |
| 491,222 | | |
$ | 1,272 | | |
| 989,954 | | |
$ | 1 | | |
$ | 282 | | |
$ | (22,928 | ) | |
$ | (91 | ) | |
$ | (22,736 | ) |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 552 | | |
| — | | |
| — | | |
| 552 | |
Issuance of common stock and warrants, net of issuance costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| 3,200,000 | | |
| 3 | | |
| 13,762 | | |
| — | | |
| — | | |
| 13,765 | |
Common stock issued upon conversion of Series A preferred stock | |
| (2,550,763 | ) | |
| (12,367 | ) | |
| — | | |
| — | | |
| 2,447,728 | | |
| 2 | | |
| 12,365 | | |
| | | |
| | | |
| 12,367 | |
Common stock issued upon conversion of Series B preferred stock | |
| — | | |
| — | | |
| (491,222 | ) | |
| (1,272 | ) | |
| 245,614 | | |
| — | | |
| 1,272 | | |
| | | |
| | | |
| 1,272 | |
Common stock issued upon conversion of debt | |
| — | | |
| — | | |
| — | | |
| — | | |
| 3,955,415 | | |
| 4 | | |
| 13,864 | | |
| — | | |
| — | | |
| 13,868 | |
Common stock issued for services | |
| — | | |
| — | | |
| — | | |
| — | | |
| 398,090 | | |
| 1 | | |
| 1,560 | | |
| — | | |
| — | | |
| 1,561 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (48 | ) | |
| (48 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (5,488 | ) | |
| — | | |
| (5,488 | ) |
Balance at June 30, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 11,236,801 | | |
$ | 11 | | |
$ | 43,657 | | |
$ | (28,416 | ) | |
$ | (139 | ) | |
$ | 15,113 | |
Six months ended June 30, 2023 and 2022:
| |
Series A Convertible Preferred Stock | | |
Series B Convertible Preferred Stock | | |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Total | |
Balance at December 31, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 11,236,801 | | |
$ | 11 | | |
$ | 45,833 | | |
$ | (39,492 | ) | |
$ | (100 | ) | |
$ | 6,252 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 2,094 | | |
| — | | |
| — | | |
| 2,094 | |
Release of restricted stock units | |
| — | | |
| — | | |
| — | | |
| — | | |
| 386,968 | | |
| 1 | | |
| (1 | ) | |
| — | | |
| — | | |
| — | |
Issuance of common stock and warrants, net of issuance costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| 10,000,000 | | |
| 10 | | |
| 1,634 | | |
| — | | |
| — | | |
| 1,644 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 28 | | |
| 28 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (9,115 | ) | |
| — | | |
| (9,115 | ) |
Balance at June 30, 2023 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 21,623,769 | | |
$ | 22 | | |
$ | 49,560 | | |
$ | (48,607 | ) | |
$ | (72 | ) | |
$ | 903 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2021 | |
| 2,550,763 | | |
$ | 12,367 | | |
| 491,222 | | |
$ | 1,272 | | |
| 989,954 | | |
$ | 1 | | |
$ | 113 | | |
$ | (20,575 | ) | |
$ | (91 | ) | |
$ | (20,552 | ) |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 721 | | |
| — | | |
| — | | |
| 721 | |
Issuance of common stock and warrants, net of issuance costs | |
| — | | |
| — | | |
| — | | |
| — | | |
| 3,200,000 | | |
| 3 | | |
| 13,762 | | |
| — | | |
| — | | |
| 13,765 | |
Common stock issued upon conversion of Series A preferred stock | |
| (2,550,763 | ) | |
| (12,367 | ) | |
| — | | |
| — | | |
| 2,447,728 | | |
| 2 | | |
| 12,365 | | |
| | | |
| | | |
| 12,367 | |
Common stock issued upon conversion of Series B preferred stock | |
| — | | |
| — | | |
| (491,222 | ) | |
| (1,272 | ) | |
| 245,614 | | |
| — | | |
| 1,272 | | |
| | | |
| | | |
| 1,272 | |
Common stock issued upon conversion of debt | |
| — | | |
| — | | |
| — | | |
| — | | |
| 3,955,415 | | |
| 4 | | |
| 13,864 | | |
| — | | |
| — | | |
| 13,868 | |
Common stock issued for services | |
| — | | |
| — | | |
| — | | |
| — | | |
| 398,090 | | |
| 1 | | |
| 1,560 | | |
| — | | |
| — | | |
| 1,561 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (48 | ) | |
| (48 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (7,841 | ) | |
| — | | |
| (7,841 | ) |
Balance at June 30, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 11,236,801 | | |
$ | 11 | | |
$ | 43,657 | | |
$ | (28,416 | ) | |
$ | (139 | ) | |
$ | 15,113 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
Tenon Medical, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
| |
Six Months Ended
June 30, | |
| |
2023 | | |
2022 | |
Cash Flows from Operating Activities | |
| | |
| |
Net loss | |
$ | (9,115 | ) | |
$ | (7,841 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Non-cash interest expense | |
| — | | |
| 362 | |
Stock-based compensation expense | |
| 2,094 | | |
| 721 | |
Common stock issued for services | |
| — | | |
| 1,561 | |
Depreciation and amortization | |
| 60 | | |
| 29 | |
Amortization of operating right-of-use asset | |
| 111 | | |
| 103 | |
Increase (decrease) in cash resulting from changes in: | |
| | | |
| | |
Accounts receivable | |
| (373 | ) | |
| 1 | |
Inventory | |
| (155 | ) | |
| (440 | ) |
Prepaid expenses and other assets | |
| (325 | ) | |
| (62 | ) |
Accounts payable | |
| 362 | | |
| (133 | ) |
Accrued expenses | |
| 698 | | |
| 569 | |
Operating lease liability | |
| (109 | ) | |
| (97 | ) |
Net cash used in operating activities | |
| (6,752 | ) | |
| (5,227 | ) |
| |
| | | |
| | |
Cash Flows from Investing Activities | |
| | | |
| | |
Sales of short-term investments | |
| 6,503 | | |
| 4,404 | |
Purchases of short-term investments | |
| (493 | ) | |
| (8,141 | ) |
Purchases of fixed assets | |
| (212 | ) | |
| (169 | ) |
Net cash provided by (used in) investing activities | |
| 5,798 | | |
| (3,906 | ) |
| |
| | | |
| | |
Cash Flows from Financing Activities | |
| | | |
| | |
Proceeds from issuance of common stock and warrants, net of issuance costs | |
| 4,808 | | |
| 14,139 | |
Deferred offering costs | |
| (143 | ) | |
| — | |
Net cash provided by financing activities | |
| 4,665 | | |
| 14,139 | |
| |
| | | |
| | |
Effect of foreign currency translation on cash flow | |
| 12 | | |
| (48 | ) |
Net Increase in Cash and Cash Equivalents | |
| 3,723 | | |
| 4,958 | |
| |
| | | |
| | |
Cash and Cash Equivalents at Beginning of Period | |
| 2,129 | | |
| 2,917 | |
Cash and Cash Equivalents at End of Period | |
$ | 5,852 | | |
$ | 7,875 | |
| |
| | | |
| | |
Supplemental Disclosures of Cash Flow Information | |
| | | |
| | |
Non-cash investment and financing activities: | |
| | | |
| | |
Common stock issued upon conversion of preferred stock | |
$ | — | | |
$ | 13,639 | |
Common stock issued upon conversion of debt | |
$ | — | | |
$ | 13,868 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
Notes to Condensed Consolidated Financial Statements
(unaudited)(in thousands, except share and per-share data)
1. Organization and Business
Nature of operations
Tenon Medical, Inc. (the “Company”),
was incorporated in the State of Delaware on June 19, 2012 and was headquartered in San Ramon, California until June 2021 when it relocated
to Los Gatos, California. The Company is a medical device company that has developed a novel, minimally invasive approach to the sacroiliac
joint (the “SI Joint”) using a single, robust, titanium implant for treatment of the most common types of SI Joint disorders
that cause lower back pain. The Company received U.S. Food and Drug Administration (“FDA”) clearance in 2018 for its primary
product, The Catamaran™ SI Joint Fusion System (“The Catamaran System”) which is designed to transfix and stabilize
the SI Joint. The Company is in the early stages of its commercial launch with its only focus being on the US market.
Principles of consolidation
The condensed consolidated financial statements
of the Company include the accounts of the Company and its wholly-owned subsidiary, Tenon Technology AG (“TTAG”), a Swiss
company. All intercompany balances and transactions have been eliminated in consolidation. The financial statements of TTAG are prepared
for the same reporting period as the parent, using consistent accounting policies in all material respects.
2. Summary of Significant Accounting Principles
Basis of presentation
The accompanying unaudited condensed consolidated
financial statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission
(the “SEC”). As permitted under these rules and regulations, the Company has condensed or omitted certain financial information
and footnote disclosures normally included in its annual consolidated financial statements prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). The condensed consolidated balance sheet as
of December 31, 2022 has been derived from the Company’s audited consolidated financial statements, which are included
in its Annual Report on Form 10-K filed with the SEC on March 10, 2023.
These condensed consolidated financial statements
have been prepared on the same basis as the Company’s annual consolidated financial statements and, in management’s opinion,
reflect all adjustments, consisting only of normal recurring adjustments, that are necessary for a fair presentation of its financial
information. The interim period operating results do not necessarily indicate the results that may be expected for any other interim period
or for the full fiscal year.
These unaudited condensed consolidated financial
statements and accompanying notes should be read in conjunction with the Company’s audited consolidated financial statements as
of and for the years ended December 31, 2022 and 2021 included in its Annual Report of Form 10-K filed with the SEC on March 10, 2023.
The Company’s significant accounting policies
are disclosed in the audited consolidated financial statements as of and for the years ended December 31, 2022 and 2021. There have been
no material changes in the Company’s significant accounting policies during the six months ended June 30, 2023.
Going concern uncertainty and liquidity requirements
The accompanying consolidated financial statements
have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the settlement
of liabilities and commitments in the normal course of business. There is substantial doubt about the Company’s ability to continue
as a going concern for one year after the date that these financial statements are issued.
Since inception, the Company has incurred losses
and negative cash flows from operations. Management expects to incur additional operating losses and negative cash flows from operations
in the foreseeable future as the Company continues its product development programs and the commercialization of The Catamaran System.
On April 29, 2022, the Company closed an initial public offering (the “IPO”) of its common stock for proceeds, net of issuance
costs, of $13,765. On June 16, 2023, the Company closed a registered public offering (the “Registered Offering”) for proceeds,
net of issuance costs, of $4,808. Based on the Company’s current level of revenues and expenditures, the Company believes that its
existing cash and cash equivalents and short-term investments as of June 30, 2023 will not provide sufficient funds to enable it to meet
its obligations for a period of at least twelve months from the date of the filing of these condensed consolidated financial statements.
The Company plans to raise the necessary additional capital through one or a combination of public or private equity offerings, debt financings,
and collaborations. The condensed consolidated financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
Use of estimates
The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect certain reported amounts and
disclosures. Accordingly, actual results could differ from those estimates. Significant estimates made by management include, but are
not limited to, realization of deferred tax assets, accrued liabilities, accrued commissions, incremental borrowing rate, obsolescence
of inventory, stock-based compensation and the fair value of investments, inventory and of the Company’s common stock.
Income Taxes
The Company accounts for income taxes utilizing
ASC 740, “Income Taxes”. ASC 740 requires the measurement of deferred tax assets for deductible temporary differences and
operating loss carry forwards, and of deferred tax liabilities for taxable temporary differences. Measurement of current and deferred
tax liabilities and assets is based on provisions of enacted tax law. The effects of future changes in tax laws or rates are not included
in the measurement. The Company recognizes the amount of taxes payable or refundable for the current year and recognizes deferred tax
liabilities and assets for the expected future tax consequences of events and transactions that have been recognized in the Company’s
financial statements or tax returns. The Company currently has substantial net operating loss carry forwards. The Company has recorded
a 100% valuation allowance against net deferred tax assets due to uncertainty of their ultimate realization. Valuation allowances are
established when necessary to reduce deferred tax assets to the amount expected to be realized.
Net loss per share
Basic net loss per share is based upon the weighted
average number of common shares outstanding. Diluted net loss per share is based on the assumption that all potential common stock equivalents
(convertible preferred stock, stock options, and warrants) are converted or exercised. The calculation of diluted net loss per share excludes
potential common stock equivalents if the effect is anti-dilutive. The Company’s weighted average common shares outstanding for
basic and diluted are the same because the effect of the potential common stock equivalents is anti-dilutive.
The Company had the following dilutive common
stock equivalents as of June 30, 2023 and 2022 which were excluded from the calculation because their effect was anti-dilutive:
| |
June 30, 2023 | | |
June 30, 2022 | |
Outstanding restricted stock units | |
| 931,562 | | |
| 1,117,530 | |
Outstanding stock options | |
| 969,344 | | |
| 727,394 | |
Outstanding warrants | |
| 20,096,000 | | |
| 121,000 | |
Total | |
| 21,996,906 | | |
| 1,965,924 | |
Recent
Accounting Pronouncements Adopted
In June
2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13, “Financial Instruments-Credit Losses
(Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). This standard requires an impairment
model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses.
Under the new guidance, each reporting entity estimates an allowance for expected credit losses, which is intended to result in more
timely recognition of losses. The new standard applies to trade receivables arising from revenue transactions such as contract assets
and accounts receivable. When trade receivables are recorded, they become subject to the CECL model and estimates of expected credit losses
on trade receivables over their contractual life will be recorded at inception based on historical information, current conditions, and
reasonable and supportable forecasts. The Company adopted ASU 2016-13 as of January 1, 2023. The adoption had no material impact
on its results of operations or on its condensed consolidated financial statements.
Recent
Accounting Pronouncements Not Yet Adopted
There have been no accounting pronouncements or
changes in accounting pronouncements in the six months ended June 30, 2023 that are significant or potentially significant to the Company.
3. Investments
The following table sets forth by level, within
the fair value hierarchy, the Company’s investments at fair value as of June 30, 2023 and December 31, 2022:
| |
Level 2 | |
Corporate debt securities: | |
| |
June 30, 2023 | |
$ | 493 | |
December 31, 2022 | |
$ | 6,441 | |
Cost and fair value of available-for-sale investments
as of June 30, 2023 and December 31, 2022 are as follows:
| |
Amortized Cost | | |
Gross Unrealized Gains | | |
Gross Unrealized Losses | | |
Fair Value | |
Corporate debt securities: | |
| | |
| | |
| | |
| |
June 30, 2023 | |
$ | 493 | | |
$ | — | | |
$ | — | | |
$ | 493 | |
December 31, 2022 | |
$ | 6,457 | | |
$ | — | | |
$ | (16 | ) | |
$ | 6,441 | |
All of the investments with gross unrealized losses
have been in a continuous loss position for less than 12 months.
During the three and six months ended June 30,
2023 and 2022, the Company did not recognize any significant other-than-temporary impairment losses because the Company does not intend
to sell the investments before recovery of their amortized cost bases.
During the three and six months ended June 30,
2023, there were net gains of approximately $37 and $93, respectively, included in the Company’s net loss. During the three and
six months ended June 30, 2022, there were net gains of approximately $35 and $36, respectively, included in the Company’s net loss.
Accrued interest as of June 30, 2023 and December 31, 2022 was approximately $12 and $13, respectively, and is included in prepaid expenses
in the Company’s condensed consolidated balance sheets.
4. Fixed Assets, Net
Fixed assets, net, consisted of the following:
| |
June 30, 2023 | | |
December 31, 2022 | |
Construction in progress | |
$ | 638 | | |
$ | 601 | |
Catamaran tray sets | |
| 348 | | |
| 193 | |
IT equipment | |
| 76 | | |
| 56 | |
Lab equipment | |
| 14 | | |
| 14 | |
Office furniture | |
| 9 | | |
| 9 | |
Fixed assets, gross | |
| 1,085 | | |
| 873 | |
Less: accumulated depreciation | |
| (140 | ) | |
| (80 | ) |
Fixed assets, net | |
$ | 945 | | |
$ | 793 | |
Construction in progress is made up of reusable
components that will become Catamaran Tray Sets. Depreciation expense was approximately $35 and $19 for the three months ended June 30,
2023 and 2022, respectively. Depreciation expense was approximately $60 and $29 for the six months ended June 30, 2023 and 2022, respectively.
5. Accrued Expenses
Accrued expenses consisted of the following:
|
|
June 30,
2023 |
|
|
December 31,
2022 |
|
Accrued compensation |
|
$ |
641 |
|
|
$ |
452 |
|
Other accrued expenses |
|
|
489 |
|
|
|
265 |
|
Total accrued expenses |
|
$ |
1,130 |
|
|
$ |
717 |
|
6. Leases
In June 2021, the Company entered into a facility
lease agreement for its company headquarters in Los Gatos, California. This non-cancellable operating lease expires in June 2026. The
Company includes options that are reasonably certain to be exercised as part of the determination of lease terms. The Company may negotiate
termination clauses in anticipation of any changes in market conditions, but generally these termination options are not exercised. Residual
value guarantees are generally not included within operating leases. In addition to base rent payments, leases may require the Company
to pay directly for taxes and other non-lease components, such as insurance, maintenance, and other operating expenses, which
may be dependent on usage or vary month-to-month. Non-lease components were considered and determined not to be material. The Company
determined if an arrangement is a lease at inception of the contract and performed the lease classification test as of the lease commencement
date. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent
the obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the
lease’s commencement date based on the present value of lease payments over the lease term. When a lease did not provide an implicit
rate, the Company used its estimated incremental borrowing rate based on the information available at the commencement date in determining
the present value of future payments.
Operating lease costs for the facility lease were
$73 and $73 for the three months ended June 30, 2023 and 2022, respectively, and were $146 and $146 for the six months ended June 30,
2023 and 2022, respectively. Lease costs are included in general and administrative expenses in the condensed consolidated statements
of operations and comprehensive loss.
Supplemental balance sheet information related
to leases was as follows:
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Operating lease right-of-use assets | |
$ | 762 | | |
$ | 873 | |
| |
| | | |
| | |
Operating lease liability, current | |
$ | (242 | ) | |
$ | (228 | ) |
Operating lease liability, noncurrent | |
| (560 | ) | |
| (683 | ) |
Total operating lease liabilities | |
$ | (802 | ) | |
$ | (911 | ) |
Future maturities of operating lease liabilities
as of June 30, 2023 were as follows:
2023 | |
$ | 150 | |
2024 | |
| 301 | |
2025 | |
| 310 | |
2026 | |
| 144 | |
Total lease payments | |
| 905 | |
Less: imputed interest | |
| (103 | ) |
Present value of operating lease liabilities | |
$ | 802 | |
Other information:
Cash paid for operating leases for the six months ended June 30, 2023 | |
$ | 144 | |
Cash paid for operating leases for the six months ended June 30, 2022 | |
$ | 140 | |
Remaining lease term - operating leases (in years) | |
| 3.00 | |
Average discount rate - operating leases | |
| 8.0 | % |
7. Stockholders’ Equity
The Amended and Restated Certificate of Incorporation
dated February 18, 2014 authorized the issuance of 3,937,550 shares of common stock and 2,099,525 shares of preferred stock, with a par
value of $0.001 per share. In April 2021 the Company increased the number of authorized shares to 7,000,000 shares of common stock and
2,460,802 shares of preferred stock, and increased the number of authorized shares of Series A Preferred Stock to 1,798,905. In October
2021 the Company increased the number of authorized shares to 10,487,904 shares of common stock and 3,297,061 shares of preferred stock.
In February 2022, the Company increased the number of authorized shares to 130,000,000 shares of common stock and 20,000,000 shares of
preferred stock. With respect to the preferred stock, 4,500,000 shares are designated Series A Preferred Stock and 491,222 shares are
designated Series B Preferred Stock. As of June 30, 2023 and December 31, 2022, there were no shares of Series A Preferred stock or Series
B Preferred Stock issued and outstanding.
Reverse Stock Split
On April 6, 2022, the Company effected a 1:2 reverse
stock split (the “Reverse Stock Split”) by filing an amendment to the Company’s Amended and Restated Certificate of
Incorporation, as amended, with the Delaware Secretary of State. The Reverse Stock Split combined every two shares of our common stock
issued and outstanding immediately prior to effecting the Reverse Stock Split into one share of common stock. Similarly, shares of Series
A and Series B Preferred Stock became convertible into common stock at a conversion rate of one-to-0.5, subject to adjustments for stock
dividends, splits, combinations, and similar events. No fractional shares were issued in connection with the Reverse Stock Split. All
historical and per share amounts reflected throughout this document have been adjusted to reflect the Reverse Stock Split. The authorized
number of shares and the par value per share of the Company’s common stock were not affected by the Reverse Stock Split.
Initial Public Offering
On April 26, 2022, the Company’s Registration
Statement relating to the IPO was declared effective by the SEC. The IPO consisted of 3,200,000 shares of common stock, par value $0.001
per share at a public offering price of $5.00 per share. Pursuant to the Underwriting Agreement dated April 26, 2022, between the Company,
The Benchmark Company, LLC (“Benchmark”) and Valuable Capital Limited (together with Benchmark, the “Underwriters”),
the Company granted the Underwriters warrants to purchase a total of 96,000 shares of the Company’s common stock at an exercise
price of $5.00 per share. The warrants expire on the fifth anniversary of the commencement of sales under the IPO. On April 27, 2022,
the shares of the Company’s common stock began trading on the Nasdaq Capital Market LLC under the symbol “TNON.”
On April 29, 2022, the IPO closed, and the Company
received approximately $13.8 million in net proceeds from the IPO after deducting the underwriting discount and commission and other estimated
IPO expenses payable by the Company. As a result of the completion of the IPO, the Company converted the entirety of the outstanding principal
and accrued interest of the convertible notes payable to 3,955,415 shares of the Company’s common stock.
On April 29, 2022, as result of the completion
of the IPO, the Company converted all shares of Series A and Series B Preferred Stock to 2,693,342 shares of the Company’s common
stock at the conversion rate detailed below and issued the common stock to the preferred stockholders.
Concurrent with the completion of the IPO and
in accordance with the Amended and Restated Exclusive Sales Representative Agreement executed in May 2021, the counterparty to the agreement
received anti-dilution protections to maintain ownership of 3.0% of the fully diluted equity of the Company through the date of an initial
public offering and was issued 312,351 shares of the Company’s common stock to the Representative, fully satisfying the Company’s
obligations. Also, as a result of the completion of the IPO, the Company issued 85,739 shares of its common stock to a consultant. The
value of these shares issued at the IPO price of $5.00 per share was charged to operating expenses in the Company’s consolidated
financial statements.
Registered Offering
On June 16, 2023, the Company closed the Registered
Offering of a total of 10,000,000 units (the “Units”) for proceeds, net of issuance costs, of $4,808, with each Unit consisting
of (i) one share of the Company’s common stock, and (ii) two warrants, each warrant to purchase one share of the Company’s
common stock at an exercise price equal to $0.56 per share (the “Offering Warrants”). The Offering Warrants were exercisable
upon issuance and will expire five years from the date of issuance. Per the terms of the Offering Warrants, the exercise price reset subsequent
to quarter end on July 16, 2023 to $0.3146 per share.
Voting rights
The holders of vested shares of common stock are
entitled to vote on any matter submitted to a vote of the stockholders and each such holder is entitled to one vote per share of common
stock held. The holders of Series A and Series B Preferred Stock were entitled to vote together with the common stock as a single class
on any matter submitted to a vote of the stockholders. Holders of Series A and Series B Preferred Stock were entitled to the number of
votes equal to the number of common stock issuable upon conversion of their respective Series A and Series B Preferred Stock at the time
such shares are voted. The holders of a majority of the preferred stock had additional voting rights as specified in the Company’s
Amended and Restated Certificate of Incorporation, as amended.
Equity awards
In 2012, the Board of Directors of the Company
(the “Board”) approved the Tenon Medical, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides
for the issuance of common stock options, appreciation rights, and other awards to employees, directors, and consultants. Options issued
under the 2012 Plan generally vest over a period of two to four years and have a 10-year expiration date. In April 2021, the Board increased
the number of shares of common stock reserved for issuance under the 2012 Plan to 662,516. In July 2021, the Board increased the number
of shares of common stock reserved for issuance under the 2012 Plan to 737,516. In August 2021, the Board increased the number of shares
of common stock reserved for issuance under the 2012 Plan from 737,516 shares to 799,266 shares and approved the form of a 2022 Equity
Incentive Plan.
On January 10, 2022 and February 2, 2022, the
Board and stockholders, respectively, of the Company approved the Tenon Medical, Inc. 2022 Equity Incentive Plan (the “2022 Plan”),
which was effective on April 25, 2022. The number of shares of common stock that may be subject to awards and sold under the 2022 Plan
is equal to 1,600,000. Automatic annual increases in number of shares available for issuance under the 2022 Plan is equal to the least
of (a) 1,100,000 shares, (b) 4% of the total number of shares of all classes of common stock outstanding on the last day of the immediately
preceding fiscal year, or (c) such number determined by the 2022 Plan administrator no later than the last day of the immediately preceding
fiscal year. Annual increases will continue until the tenth anniversary of the earlier of the Board or stockholder approval of the 2022
Plan, which is January 10, 2032. Upon the effective date of the 2022 Plan, the Board terminated the 2012 Plan such that no new equity
awards will be issued by the 2012 Plan.
Compensation expense for the three and six months
ended June 30, 2023 and 2022 includes the portion of awards vested in the periods for all equity-based awards granted, based on the grant
date fair value estimated using a Black-Scholes option valuation model.
A summary of the Company’s stock option
and restricted stock unit activity under its plans is as follows:
|
|
Stock Options |
|
|
Restricted Stock Units |
|
|
|
Number of
Shares
Subject to Outstanding
Stock Options |
|
|
Weighted Average Exercise Price per Share |
|
|
Number of
Outstanding
Restricted Stock
Units |
|
|
Weighted
Average Grant
Date Fair
Value per
Share |
|
Outstanding at December 31, 2022 |
|
|
898,844 |
|
|
$ |
4.74 |
|
|
|
1,318,530 |
|
|
$ |
7.93 |
|
Granted |
|
|
75,500 |
|
|
$ |
2.32 |
|
|
|
— |
|
|
|
— |
|
Released |
|
|
— |
|
|
|
— |
|
|
|
(386,968 |
) |
|
$ |
8.63 |
|
Canceled/Forfeited |
|
|
(5,000 |
) |
|
$ |
7.50 |
|
|
|
— |
|
|
|
— |
|
Outstanding at June 30, 2023 |
|
|
969,344 |
|
|
$ |
4.55 |
|
|
|
931,562 |
|
|
$ |
7.64 |
|
The following table sets forth stock-based compensation
expense recognized for the three and six months ended June 30, 2023 and 2022:
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 378 | | |
$ | 178 | | |
$ | 750 | | |
$ | 207 | |
Sales and marketing | |
| 58 | | |
| 12 | | |
| 116 | | |
| 24 | |
General, and administrative | |
| 618 | | |
| 362 | | |
| 1,228 | | |
| 490 | |
Total stock-based compensation expense | |
$ | 1,054 | | |
$ | 552 | | |
$ | 2,094 | | |
$ | 721 | |
At June 30, 2023, there were 488,992 shares available
for issuance under the 2022 Plan.
Warrants
In April 2022, as noted above, the Company granted
the Underwriters warrants to purchase a total of 96,000 shares of the Company’s common stock. The warrants are immediately exercisable
at an exercise price of $5.00 per share and expire on the fifth anniversary of the commencement of sales under the IPO. The fair value
of the warrants on the grant date was $2.75 per warrant, which was calculated based on the following weighted average assumptions, using
a Black-Scholes option valuation model: expected term of 5.00 years; expected volatility of 62.55%; dividend yield of 0%; and risk-free
interest rate of 2.92%. The Company recorded the fair value of these warrants of approximately $264 as an issuance cost to additional
paid-in capital in 2022. As the IPO issuance costs were also recorded to additional paid-in capital, the net impact was $0.
In June 2023, as noted above, in connection
with the Registered Offering, the Company issued Offering Warrants to purchase a total of 20,000,000 shares of the Company’s
common stock. The Offering Warrants were exercisable upon issuance at an exercise price of $0.56 per share and will expire five
years from the date of issuance. Per the terms of the Offering Warrants, the exercise price of the Offering Warrants reset on July
16, 2023, to a price equal to the greater of (i) $0.28 per share and (ii) 100% of the last VWAP (as defined in the Warrants) on July
14, 2023. The fair value of the Offering Warrants on the grant date was approximately $3,164, or $0.16 per warrant, which was
calculated using a Monte-Carlo simulation to estimate the final exercise price, which is considered a Level 3 fair value measurement, using as inputs; the starting
value of $0.30 per share, the Company’s VWAP on June 16; an assumed daily distribution of returns; a mean daily return of
5.18%; a short-term annual volatility of 100% and a standard deviation of 6.3%. The model used Black-Scholes to then calculate the estimated fair value of the Offering Warrants, using an estimated time to maturity
of 4.9 years, a risk-free interest rate of 3.99% and a long-term volatility of 60%. The change in fair value at June 30, 2023 was
immaterial and there were no unrealized gains or losses. Based on the accounting guidance under ASC 815, the Company determined that
the Offering Warrants did not meet the criteria for classification as equity as of June 30, 2023. Accordingly, the Company
classified the fair value of the Offering Warrants as a liability. The total of the Company’s stockholders’ equity plus
the warrant liability at June 30, 2023 was $4,067. See Note 10.
8. Commitments and Contingencies
Sales Representative Agreement
In April 2020, the Company entered into an Exclusive
Sales Representative Agreement, under which the counterparty to the agreement (the “Representative”) received exclusive rights
to market, promote, and distribute The Catamaran System in the United States and Puerto Rico. The agreement is for an initial period of
five years, and automatically renews for an additional five years unless written notice is given by either party prior to April 27, 2023.
The agreement provides for a bonus to be paid to the Representative upon an acquisition or IPO. In May 2021, the Company entered into
an Amended and Restated Exclusive Sales Representative Agreement (the “Restated Sales Agreement”). In connection with the
amended agreement, the Company paid $500 cash and issued 53,757 shares of common stock to the Representative, for which the Company recorded
a combined total of approximately $880 as sales and marketing expense. In addition, the Representative received anti-dilution protections
to maintain ownership of 3.0% of the fully diluted equity of the Company through the date of an initial public offering. In October 2021,
the Company issued 44,447 shares of common stock with a fair value of approximately $333 to the Representative in accordance with the
anti-dilution provision. In April 2022, the Company issued 312,351 shares of common stock to the Representative in accordance with the
anti-dilution provision, fully satisfying the Company’s obligations.
The Restated Sales Agreement restructured the
calculation of the bonus paid to the Representative upon an acquisition, removed the bonus payable upon an IPO, and allows the Company
to terminate the Restated Sales Agreement as long as the bonus paid to the Representative is at least $6,000.
On October 6, 2022, the Company entered into the
Terminating Amended and Restated Exclusive Sales Representative Agreement (the “Termination Agreement”) with the Representative,
which terminated the Restated Sales Agreement. In accordance with the Termination Agreement, (i) the Company paid the Representative $1,000
in cash; and (ii) the Company agreed to pay the Representative (a) $85 per month during the six months after the date of the Termination
Agreement in return for efforts by the Representative to transition operations to the Company, (b) 20% of net sales of the product sold
in the United States and Puerto Rico until December 31, 2023 and (c) after December 31, 2023, 10% of net sales until such time as the
aggregate amount paid to the Representative under this clause (c) and clause (b) above equal $3,600. In the event of an acquisition of
the Company, the Company will pay the Representative $3,600 less previous amounts paid pursuant to clause (b) and clause (c) above. The
Company recorded a charge of $1,000 for the payment to the Representative in the fourth quarter of 2022 and is expensing the $85 per charges
as incurred over the six-month period. For payments under clause (b) and clause (c) above, the Company estimated the fair value of the
liability using level 3 hierarchy inputs based on a Monte Carlo simulation of future revenues with a 25% quarterly estimated standard
deviation of growth rates and a 10% probability of dissolution, discounted at an estimated discount rate of 15.4%. Based on the Company’s
fair value analysis, a total of $2,611 was charged to sales and marketing expense in the consolidated statements of operations and comprehensive
loss and recorded as accrued commissions in the consolidated balance sheets. A reconciliation of the liability under clause (b) and clause
(c) for the six months ended June 30, 2023 is as follows:
| |
2023 | |
Balance at December 31, 2022 | |
$ | 2,560 | |
Amounts paid during 2023 | |
| (205 | ) |
Accretion | |
| 293 | |
Balance at June 30, 2023 | |
$ | 2,648 | |
Per the terms of the Termination Agreement, the
Company ultimately expects to expense $3,600 under clause (b) and clause (c).
Simultaneously with the execution of the Termination
Agreement, the Company entered into a Consulting Agreement dated October 6, 2022, with the Representative (the “Consulting Agreement”).
Under the terms and conditions of the Consulting Agreement, the Representative is tasked with organizing, recruiting, training, and coordinating
the Company’s Clinical Specialist program, Physician Education program and Sales Education program as more specifically described
in the Consulting Agreement.
The term of the Consulting Agreement is from October
6, 2022, until October 05, 2023, unless extended by mutual agreement of the parties in writing for additional one-year terms, or terminated
in accordance with the terms of the Consulting Agreement. In consideration for the services to be provided, the Company shall pay the
Representative a base consulting fee of $700 per year, payable in monthly installments, along with additional compensation of up to $62.5
per quarter, if certain sales targets are met, for four quarters; along with any travel and related out-of-pocket expenses incurred by
the Representative in connection with the performance of the services.
Litigation
In the normal course of business, the Company
may possibly be named as a defendant in various lawsuits.
9. Concentrations of Risk
Credit risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist principally of cash and cash equivalents.
The Company maintains cash balances at financial
institutions located in California and Switzerland. Accounts at the U.S. financial institutions are secured by the Federal Deposit Insurance
Corporation. At times, balances may exceed federally insured limits. The Company has not experienced any losses in such accounts. Management
believes that the Company is not exposed to any significant credit risk with respect to its cash and cash equivalents.
The Company grants unsecured credit to its customers
based on an evaluation of the customer’s financial condition and a cash deposit is generally not required. Management believes its
credit policies do not result in significant adverse risk and historically has not experienced significant credit-related losses.
Currency risk
The Company’s subsidiary, Tenon Technology
AG, realizes a portion of its expenses in Swiss francs. Consequently, certain assets and liabilities are exposed to foreign currency fluctuations.
At June 30, 2023 and December 31, 2022, approximately $18 and $8, respectively, of the Company’s net monetary assets were denominated
in Swiss francs. The Company has not entered into any hedging transactions to reduce the exposure to currency risk.
10. Subsequent Events
Offering Warrant Reset
As noted in Note 7 above, in June 2023, in connection
with the Registered Offering, the Company issued Offering Warrants to purchase a total of 20,000,000 shares of the Company’s common
stock. The Offering Warrants were exercisable upon issuance at an exercise price of $0.56 per share and will expire five years from the
date of issuance. Based on the accounting guidance under ASC 815, the Company determined that the Offering Warrants did not meet the criteria
for classification as equity as of June 30, 2023. Accordingly, the Company classified the fair value of the Offering Warrants as a liability
on its consolidated balance sheet as of that date. Per the terms of the Offering Warrants, the exercise price was reset on July 16, 2023
to $0.3146 per share. There will be no further mandatory price resets. As of July 16, 2023, with the resolution of the reset value, the
Company has determined that the Offering Warrants do meet the criteria for classification as equity and the fair value of the Offering
Warrants has been reclassified to additional paid-in capital on the Company’s consolidated balance sheet as of that date. As a result
of this reclassification, the Company believes that its Shareholder Equity will exceed $2.5 million and will therefore meet the minimum
shareholder equity amount required by the Nasdaq Stock Market LLC (“Nasdaq”).
Notice from Nasdaq
On July 20, 2023, the Company received a letter from the Nasdaq Listing
Qualifications Staff of Nasdaq therein stating that for the 30 consecutive business day period between June 6, 2023 through July 19, 2023,
the common stock of the Company had not maintained a minimum closing bid price of $1.00 per share required for continued listing on The
Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A),
the Company was provided an initial period of 180 calendar days, or until January 16, 2024 (the “Compliance Period”), to regain
compliance with the Bid Price Rule.
To regain compliance, the closing bid price of
the Company’s common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive trading days, unless extended by
Nasdaq under Nasdaq Rule 5810(c)(3)(H), prior to January 16, 2024.
If the Company does not regain compliance with
the Bid Price Rule by January 16, 2024, the Company may be eligible for an additional 180-day period to regain compliance. To qualify,
the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial
listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Rule, and would need to provide written notice of
its intention to cure the bid price deficiency during the second compliance period, by effecting a reverse stock split, if necessary.
If the Company cannot regain compliance during
the Compliance Period or any subsequently granted compliance period, the common stock of the Company will be subject to delisting. At
that time, the Company may appeal the delisting determination to a Nasdaq hearings panel.
The notice from Nasdaq has no immediate effect
on the listing of the Company’s common stock and its common stock will continue to be listed on The Nasdaq Capital Market under
the symbol “TNON.” The Company is currently evaluating its options for regaining compliance. There can be no assurance that
the Company will regain compliance with the Bid Price Rule or maintain compliance with any of the other Nasdaq continued listing requirements.
Equity Line of Credit
On July 24, 2023, the Company entered into a purchase
agreement (“Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), under which, subject to
specified terms and conditions, the Company may sell to Lincoln Park up to $10 million of shares of common stock from time to time during
the term of the Purchase Agreement. Additionally, on July 24, 2023, the Company entered into a registration rights agreement (the “Registration
Rights Agreement”) with Lincoln Park, pursuant to which the Company agreed to file a registration statement with the Securities
and Exchange Commission (the “SEC”), covering the resale of shares of common stock issued to Lincoln Park under the Purchase
Agreement.
The Company cannot sell any shares to Lincoln
Park until the date that a registration statement covering the resale of shares of common stock that have been and may in the future be
issued to Lincoln Park under the Purchase Agreement, which the Company agreed to file with the SEC pursuant to the Registration Rights
Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and all of the other conditions set
forth in the Purchase Agreement are satisfied (such date, the “Commencement Date”).
Beginning on the Commencement Date and for a period
of 24 months thereafter, under the terms and subject to the conditions of the Purchase Agreement, from time to time, at the Company’s
discretion, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up
to $10 million of shares of common stock, subject to certain limitations set forth in the Purchase Agreement. Specifically, from time
to time from and after the Commencement Date, the Company may, at its discretion, direct Lincoln Park to purchase on any single business
day on which the closing price of its common stock on The Nasdaq Capital Market (“Nasdaq”) is equal to or greater than $0.15
up to 100,000 shares of common stock (a “Regular Purchase”); provided, that the Company may direct Lincoln Park to purchase
in a Regular Purchase (i) up to 125,000 shares of common stock, if the closing sale price of its common stock on Nasdaq on such business
day is at least $1.50 per share and (ii) up to 150,000 shares of common stock, if the closing sale price of its common stock on Nasdaq
on such business day is at least $2.50 per share. In no case, however, will Lincoln Park’s commitment with respect to any single
Regular Purchase exceed $500,000; provided, that the parties may mutually agree at any time to increase the maximum number of shares of
common stock the Company may direct Lincoln Park to purchase in any single Regular Purchase to up to 1,000,000 shares or any number of
shares that shall not exceed 4.99% of the then outstanding shares of common stock. The foregoing share amounts and per share prices will
be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction
occurring after the date of the Purchase Agreement with respect to our common stock. The purchase price per share for each such Regular
Purchase will be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale, as determined
under the Purchase Agreement.
If the Company directs Lincoln Park to purchase
the maximum number of shares of common stock that the Company may sell in a Regular Purchase, then in addition to such Regular Purchase,
and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park to purchase additional
shares of common stock in an “accelerated purchase” (each, an “Accelerated Purchase”) and an “additional
accelerated purchase” (each, an “Additional Accelerated Purchase”) (including multiple Additional Accelerated Purchases
on the same trading day) as provided in the Purchase Agreement. The purchase price per share for each Accelerated Purchase and Additional
Accelerated Purchase will be based on market prices of the common stock on the applicable purchase date for such Accelerated Purchases
and such Additional Accelerated Purchases. Lincoln Park has no right to require the Company to sell any common stock to Lincoln Park,
but Lincoln Park is obligated to make purchases as the Company directs, subject to conditions and limitations set forth in the Purchase
Agreement.
The Purchase Agreement also prohibits the Company
from directing Lincoln Park to purchase any shares of common stock if those shares, when aggregated with all other shares of common stock
then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial ownership,
at any single point in time, of more than 4.99% of the then total outstanding shares of common stock.
The Company’s net proceeds under the Purchase
Agreement will depend on the frequency of sales and the number of shares sold to Lincoln Park and the prices at which the Company sells
shares to Lincoln Park. The Company expects that any net proceeds it receives from such sales to Lincoln Park will be used for general
corporate purposes, including working capital. As consideration for Lincoln Park’s commitment to purchase up to $10 million of shares
of common stock under the Purchase Agreement, the Company issued 989,087 shares of common stock to Lincoln Park (the “Commitment
Shares”).
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis is intended
as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion
should be read in conjunction with our unaudited condensed consolidated financial statements and the related notes included elsewhere
in this Quarterly Report on Form 10-Q and the audited financial statements and the other information set forth in the Registration Statement.
In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of
Operations contains forward-looking statements that involve risks and uncertainties. Our actual results could differ significantly from
those anticipated in these forward-looking statements as a result of certain factors discussed herein and any other periodic reports filed
and to be filed with the SEC.
Overview
Tenon Medical, Inc., a medical device company
formed in 2012, has developed a proprietary, U.S. Food and Drug Administration (“FDA”) approved surgical implant-system, which
we call The Catamaran™ SI Joint Fusion System (“The Catamaran System”). The Catamaran System offers a novel, less invasive
inferior-posterior approach to the sacroiliac joint (“SI Joint”) using a single, robust titanium implant to treat SI Joint
dysfunction that often causes severe lower back pain. The system features the Catamaran™ Fixation Device which passes through both
the axial and sagittal planes of the ilium and sacrum, transfixing the SI Joint along its longitudinal axis. Published clinical studies
have shown that 15% to 30% of all chronic lower back pain is associated with the SI Joint.
With an entry similar to the SI Joint injection,
the surgical approach is direct to the joint. The angle and trajectory of the inferior-posterior approach is designed to point away from
critical neural and vascular structures and into the strongest cortical bone. Joined by a patented osteotome bridge, the implant design
consists of two hollow fenestrated pontoons with an open framework to facilitate bony in-growth through the SI Joint. One pontoon fixates
into the ilium and the other into the sacrum. The osteotome is designed to disrupt the articular portion of the joint to help facilitate
a fusion response.
Our initial clinical results indicate that The
Catamaran System implant is promoting fusion across the joint as evidenced by computerized tomography (CT) scans which is the gold standard
widely accepted by the clinical community. We had our national launch of The Catamaran System in October 2022 and are building a sales
and marketing infrastructure to market our product and address the greatly underserved market opportunity that exists.
We believe that the implant design and procedure
we have developed, along with the 2D and 3D protocols for proper implantation will be received well by the clinician community who have
been looking for a next generation device.
We have incurred net losses since our inception
in 2012. As of June 30, 2023, we had an accumulated deficit of approximately $48.6 million. To date, we have financed our operations
primarily through an initial public offering, private placements of equity securities, certain debt-related financing arrangements, and
sales of our product. We have devoted substantially all of our resources to research and development, regulatory matters and sales and
marketing of our product.
Reverse Stock Split
On April 6, 2022, we effected the Reverse Stock
Split. Any fractional shares that would have resulted from the Reverse Stock Split were rounded up to the nearest whole share. Our authorized
common stock was not impacted by the Reverse Stock Split. Immediately after the Reverse Stock Split there were 989,954 shares of our common
stock outstanding. Profit per share and share amounts for the condensed consolidated financial statements as of and for the periods ended
June 30, 2022 reflect the impact of the Reverse Stock Split.
Components of Results of Operations
Revenue
We derive substantially all our revenue from sales
of The Catamaran System to a limited number of clinicians. Revenue from sales of The Catamaran System fluctuates based on volume of cases
(procedures performed), discounts, and the number of implants used for a particular patient. Similar to other orthopedic companies, our
revenue can also fluctuate from quarter to quarter due to a variety of factors, including reimbursement, changes in independent sales
representatives and physician activities.
Cost of Goods Sold, Gross Profit, and Gross
Margin
We utilize contract manufacturers for production
of The Catamaran System implants and Catamaran Tray Sets. Cost of goods sold consists primarily of costs of the components of The Catamaran
System implants and instruments, quality inspection, packaging, scrap and inventory obsolescence, as well as distribution-related expenses
such as logistics and shipping costs. We anticipate that our cost of goods sold will increase in absolute dollars as case levels increase.
Our gross margins have been and will continue
to be affected by a variety of factors, including the cost to have our product manufactured for us, pricing pressure from increasing competition,
and the factors described above impacting our revenue.
Operating Expenses
Our operating expenses consist of sales and marketing,
research and development, and general and administrative expenses. Personnel costs are the most significant component of operating expenses
and consist of consulting expenses, salaries, sales commissions and other cash and stock-based compensation related expenses. We expect
operating expenses to increase in absolute dollars as we continue to invest and grow our business.
Sales and Marketing Expenses
Sales and marketing expenses primarily consist
of independent sales representative training and commissions in addition to salaries and stock-based compensation expense. Starting in
May 2021, commissions to our national distributor have been based on a percentage of sales and we anticipate that these commissions will
make up a significant portion of our sales and marketing expenses. We expect our sales and marketing expenses to increase in absolute
dollars with the commercial launch of The Catamaran System resulting in higher commissions and salaries, increased clinician and sales
representative training, and the start of clinical studies to gain wider clinician adoption of The Catamaran System. Our sales and marketing
expenses may fluctuate from period to period due to timing of sales and marketing activities related to the commercial launch of our product.
Research and Development Expenses
Our research and development expenses primarily
consist of engineering, product development, regulatory expenses, and consulting services, outside prototyping services, outside research
activities, materials, and other costs associated with development of our product. Research and development expenses also include related
personnel and consultants’ compensation and stock-based compensation expense. We expense research and development costs as they
are incurred. We expect research and development expense to increase in absolute dollars as we improve The Catamaran System, develop new
products, add research and development personnel, and undergo clinical activities that may be required for regulatory clearances of future
products.
General and Administrative Expenses
General and administrative expenses primarily
consist of salaries, consultants’ compensation, stock-based compensation expense, and other costs for finance, accounting, legal,
compliance, and administrative matters. We expect our general and administrative expenses to increase in absolute dollars as we add personnel
and information technology infrastructure to support the growth of our business. We also expect to incur additional general and administrative
expenses as a result of operating as a public company, including but not limited to: expenses related to compliance with the rules and
regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are traded; additional insurance expenses; investor
relations activities; and other administrative and professional services. While we expect the general and administrative expenses to increase
in absolute dollars, we anticipate that it will decrease as a percentage of revenue over time.
Gain (Loss) on Investments, Interest Expense
and Other Income (Expense), Net
Gain (loss) on investments consists of interest
income and realized gains and losses from the sale of our investments in money market and corporate debt securities. Interest expense
is related to borrowings and includes deemed interest derived from the beneficial conversion prices of notes payable. Other income and
expenses have not been significant to date.
Results of Operations
The following table sets forth our results of
operations for the periods presented (in thousands):
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
Consolidated Statements of Operations Data: | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
$ | 743 | | |
$ | 135 | | |
$ | 1,176 | | |
$ | 206 | |
Cost of goods sold | |
| 549 | | |
| 271 | | |
| 1,029 | | |
| 546 | |
Gross (loss) profit | |
| 194 | | |
| (136 | ) | |
| 147 | | |
| (340 | ) |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 901 | | |
| 657 | | |
| 1,735 | | |
| 1,219 | |
Sales and marketing | |
| 1,883 | | |
| 1,943 | | |
| 3,909 | | |
| 2,219 | |
General and administrative | |
| 1,732 | | |
| 2,720 | | |
| 3,711 | | |
| 3,757 | |
Total operating expenses | |
| 4,516 | | |
| 5,320 | | |
| 9,355 | | |
| 7,195 | |
Loss from operations | |
| (4,322 | ) | |
| (5,456 | ) | |
| (9,208 | ) | |
| (7,535 | ) |
Interest and other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 37 | | |
| 35 | | |
| 93 | | |
| 36 | |
Interest expense | |
| — | | |
| (88 | ) | |
| — | | |
| (362 | ) |
Other income (expense) | |
| — | | |
| 21 | | |
| — | | |
| 20 | ) |
Net loss | |
$ | (4,285 | ) | |
$ | (5,488 | ) | |
$ | (9,115 | ) | |
$ | (7,841 | ) |
The following table sets forth our results of
operations as a percentage of revenue:
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
Consolidated Statements of Operations Data: | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
| 100 | % | |
| 100 | % | |
| 100 | % | |
| 100 | % |
Cost of goods sold | |
| 74 | | |
| 201 | | |
| 88 | | |
| 265 | |
Gross profit | |
| 26 | | |
| (101 | ) | |
| 12 | | |
| (165 | ) |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 121 | | |
| 487 | | |
| 148 | | |
| 592 | |
Sales and marketing | |
| 253 | | |
| 1,439 | | |
| 332 | | |
| 1,077 | |
General and administrative | |
| 233 | | |
| 2,015 | | |
| 316 | | |
| 1,824 | |
Total operating expenses | |
| 608 | | |
| 3,941 | | |
| 795 | | |
| 3,493 | |
Loss from operations | |
| (582 | ) | |
| (4,041 | ) | |
| (783 | ) | |
| (3,658 | |
Interest and other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Gain on investments | |
| 5 | | |
| 26 | | |
| 8 | | |
| 17 | |
Interest expense | |
| — | | |
| (65 | ) | |
| — | | |
| (176 | ) |
Other expense | |
| — | | |
| 16 | | |
| — | | |
| 10 | |
Net loss | |
| (577 | )% | |
| (4,065 | )% | |
| (775 | )% | |
| (3,806 | )% |
Comparison of the Three and Six Months Ended June 30, 2023 and 2022
(in thousands, except percentages)
Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin
| |
Three Months Ended June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Revenue | |
$ | 743 | | |
$ | 135 | | |
$ | 608 | | |
| 450 | % |
Cost of goods sold | |
| 549 | | |
| 271 | | |
| 278 | | |
| 103 | % |
Gross (loss) profit | |
$ | 194 | | |
$ | (136 | ) | |
$ | 330 | | |
| (243 | )% |
Gross (loss) profit percentage | |
| 26 | % | |
| (101 | )% | |
| | | |
| | |
| |
Six Months Ended
June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Revenue | |
$ | 1,176 | | |
$ | 206 | | |
$ | 970 | | |
| 471 | % |
Cost of goods sold | |
| 1,029 | | |
| 546 | | |
| 483 | | |
| 88 | % |
Gross (loss) profit | |
$ | 147 | | |
$ | (340 | ) | |
$ | 487 | | |
| (143 | )% |
Gross (loss) profit percentage | |
| 12 | % | |
| (165 | )% | |
| | | |
| | |
Revenue. The increase in revenue
for the three and six months ended June 30, 2023 as compared to the same periods in 2022 was primarily due to increases of 463% and 433%,
respectively, in the number of surgical procedures in which The Catamaran System was used.
Cost of Goods Sold, Gross Profit, and Gross
Margin. The increase in cost of goods sold for the three and six months ended June 30, 2023 as compared to the same periods
in 2022 was due to increases of 463% and 433%, respectively, in the number of surgical procedures performed. Gross loss and gross margin
percentage improved due to higher revenue associated with the increase in the number of surgical procedures.
Operating Expenses
| |
Three Months Ended June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Research and development | |
$ | 901 | | |
$ | 657 | | |
$ | 244 | | |
| 37 | % |
Sales and marketing | |
| 1,883 | | |
| 1,943 | | |
| (60 | ) | |
| (3 | )% |
General and administrative | |
| 1,732 | | |
| 2,720 | | |
| (988 | ) | |
| (36 | )% |
Total operating expenses | |
$ | 4,516 | | |
$ | 5,320 | | |
$ | (804 | ) | |
| (15 | )% |
| |
Six Months Ended June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Research and development | |
$ | 1,735 | | |
$ | 1,219 | | |
$ | 516 | | |
| 42 | % |
Sales and marketing | |
| 3,909 | | |
| 2,219 | | |
| 1,690 | | |
| 76 | % |
General and administrative | |
| 3,711 | | |
| 3,757 | | |
| (46 | ) | |
| (1 | )% |
Total operating expenses | |
$ | 9,355 | | |
$ | 7,195 | | |
$ | 2,160 | | |
| 30 | % |
Research and Development Expenses. Research
and development expenses for the three months ended June 30, 2023 increased as compared to the same period in 2022 primarily due to increased
stock-based compensation ($200) and payroll expenses ($100), partially offset by decreased professional fees ($37).
Research and development expenses for the six
months ended June 30, 2023 increased as compared to the same period in 2022 primarily due to increased stock-based compensation ($543)
and payroll expenses ($116), partially offset by decreased professional fees ($45).
Sales and Marketing Expenses. Sales
and marketing expenses for the three months ended June 30, 2023 decreased as compared to the same period in 2022 primarily due to decreased
consulting and professional fees ($1,340), partially offset by increased payroll expenses ($670), SpineSource transition expenses ($260),
sales commissions ($278), and stock-based compensation ($46) The increase in payroll and payroll related expenses is primarily due to
the increased number of sales and marketing employees as we build out our sales function.
Sales and marketing expenses for the six months
ended June 30, 2023 increased as compared to the same period in 2022 primarily due to increased payroll expenses ($1,330), SpineSource
transition expenses ($690), sales commissions ($610) and stock-based compensation ($92), partially offset by decreased consulting and
professional fees ($1,129). The increase in payroll and payroll related expenses is primarily due to the increased number of sales and
marketing employees as we build out our sales function.
General and Administrative Expenses. General
and administrative expenses for the three months ended June 30, 2023 decreased as compared to the same period in 2022 primarily due to
a legal settlement accrual in 2022 ($574) and decreased professional service fees ($517) partially offset by increased stock-based compensation
($256), and payroll expenses ($62).
General and administrative expenses for the six
months ended June 30, 2023 decreased as compared to the same period in 2022 primarily due to a legal settlement accrual in 2022 ($574)
and decreased professional service fees ($489), partially offset by increased stock-based compensation ($738) and payroll expenses ($245).
The increase in general and administrative expenses in 2023 exclusive of the legal settlement accrual was primarily due to the Company’s
ongoing transition to an operating company and the creation of an infrastructure to support future growth through the hiring of employees.
Gain (Loss) on Investments, Interest Expense
and Other Income (Expense), Net
Gain on investments for the three and six months
ended June 30, 2023 increased approximately $2 and $57, respectively, as compared to the three and six months ended June 30, 2022 due
to interest on our investments in money market and corporate debt securities. We had no interest expense for the three and six months
ended June 30, 2023 and interest expense for the three and six months ended June 30, 2022 of $88 and $362 related to our convertible debt.
Liquidity and Capital Resources; Going Concern
As of June 30, 2023, we had cash and cash equivalents
and short-term investments of approximately $6.3 million. Since inception, we have financed our operations through private placements
of preferred stock, debt financing arrangements, our initial public offering and the sale of our products. As of June 30, 2023, we had
no outstanding debt.
As of June 30, 2023, we had an accumulated deficit
of approximately $48.6 million and expect to incur additional losses in the future. We have not achieved positive cash flow from
operations to date. On April 29, 2022, we closed an initial public offering of our common stock. On June 16, 2023, we closed a registered
public offering. Based upon our current operating plan, we believe that our existing cash and cash equivalents will not be sufficient
to fund our operating expenses and capital expenditure requirements through at least the next 12 months from the date these consolidated
financial statements were available to be released. We plan to raise the necessary additional capital through one or a combination of
public or private equity offerings, debt financings, and collaborations. We continue to face challenges and uncertainties and, as a result,
our available capital resources may be consumed more rapidly than currently expected due to (a) the uncertainty of future revenues from
The Catamaran System; (b) changes we may make to the business that affect ongoing operating expenses; (c) changes we may make
in our business strategy; (d) regulatory developments affecting our existing products; (e) changes we may make in our research
and development spending plans; and (f) other items affecting our forecasted level of expenditures and use of cash resources.
As we attempt to raise additional capital to fund
our operations, funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when
needed, we may have to delay, reduce the scope of or suspend one or more of our sales and marketing efforts, research and development
activities, or other operations. We may seek to raise any necessary additional capital through a combination of public or private equity
offerings, debt financings, and collaborations. If we do raise additional capital through public or private equity offerings, the ownership
interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences
that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants
limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring
dividends. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs. Doing so
will likely harm our ability to execute our business plans. Due to the uncertainty in our ability to raise capital, management believes
that there is substantial doubt in our ability to continue as a going concern for the next twelve months from the issuance of these consolidated
financial statements.
We plan to use our cash within the twelve months
from June 30, 2023 and beyond for working capital and research and development.
Contractual Obligations
The following table summarizes our contractual obligations as of June
30, 2023:
|
|
Payments Due By Period
(In thousands) |
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
More than |
|
|
|
Total |
|
|
1 year |
|
|
1-3 years |
|
|
4-5 years |
|
|
5 years |
|
Operating leases |
|
$ |
905 |
|
|
$ |
150 |
|
|
$ |
611 |
|
|
$ |
144 |
|
|
$ |
— |
|
Purchase obligations |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total |
|
$ |
905 |
|
|
$ |
150 |
|
|
$ |
611 |
|
|
$ |
144 |
|
|
$ |
— |
|
Obligations under Terminated Sales Representative
Agreement: On October 6, 2022, we entered into the Terminating Amended and Restated Exclusive Sales Representative Agreement (the
“Termination Agreement”). In accordance with the Termination Agreement, (i) we paid the Representative $1,000 in cash; and
(ii) we agreed to pay the Representative (a) $85 per month during the six months after the date of the Termination Agreement in return
for efforts by the Representative to transition operations to us, (b) 20% of net sales of the Product sold in the United States and Puerto
Rico until December 31, 2023 and (c) after December 31, 2023, 10% of net sales until such time as the aggregate amount paid to the Representative
under this clause (c) and clause (b) above equal $3,600. In the event of an acquisition, we will pay the Representative $3,600 less previous
amounts paid pursuant to clause (b) and clause (c) above. The timing of the payments under clause (b) and (c) is variable depending on
the timing of our sales.
Cash Flows (in thousands, except percentages)
The following table sets forth the primary sources
and uses of cash for each of the periods presented below:
| |
Six Months Ended June 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Net cash (used in) provided by: | |
| | |
| | |
| | |
| |
Operating activities | |
$ | (6,752 | ) | |
$ | (5,227 | ) | |
$ | (1,525 | ) | |
| 29 | % |
Investing activities | |
| 5,798 | | |
| (3,906 | ) | |
| 9,704 | | |
| (248 | )% |
Financing activities | |
| 4,665 | | |
| 14,139 | | |
| (9,474 | ) | |
| (67 | )% |
Effect of foreign currency translation on cash flow | |
| 12 | | |
| (48 | ) | |
| 60 | | |
| (125 | )% |
Net increase in cash and cash equivalents | |
$ | 3,723 | | |
$ | 4,958 | | |
$ | (1,235 | ) | |
| (25 | )% |
The decrease in net cash used in operating activities
for the six months ended June 30, 2023 as compared to the six months ended June 30, 2022 was primarily attributable to our increased net
loss of $1.3 million, adjusted for increases in non-cash stock-based compensation expenses ($1,373) and a decrease in common stock
issued for services (1,561), in addition to increases in inventory ($285) and accounts payable ($495).
Cash provided by investing activities for the
six months ended June 30, 2023 consisted primarily of the net sales of short-term investments of approximately $6.0 million to use to
fund our operations, partially offset by purchases of property and equipment of $0.2 million. Cash used in investing activities for the
six months ended June 30, 2022 consisted primarily of the net purchases of short-term investments of $3.7 million and purchases of property
and equipment of $0.2 million.
Cash provided by financing activities for the
six months ended June 30, 2023 consisted primarily of the $4.8 million, net of relevant expenses, received from our registered offering
in June 2023. Cash provided by financing activities for the six months ended June 30, 2022 consisted of the $14.1 million cash received
from our initial public offering in April 2022, net of relevant expenses.
Critical Accounting Policies, Significant Judgments,
and Use of Estimates
Our management’s discussion and analysis
of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with
U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts
of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as
the reported results of operations during the reporting periods. Our estimates are based on our historical experience and on various other
factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from three other sources. Actual results could differ from these estimates
under different assumptions or conditions. For the six months ended June 30, 2023, there were no significant changes to our existing critical
accounting policies from those disclosed on our Annual Report on Form 10-K.
Off-Balance Sheet Arrangements
As of June 30, 2023, and December 31, 2022, we
did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose
entities that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually
narrow or limited purposes.
ITEM 3. Quantitative and Qualitative Disclosures
about Market Risk
Not required under Regulation S-K for “smaller
reporting companies.”
ITEM 4. Controls and Procedures. Disclosure
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures
that are designed to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported
within the time periods specified in the rules and forms promulgated by the Securities and Exchange Commission, and that such information
is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to
allow timely decisions regarding required disclosure. Because of the inherent limitations to the effectiveness of any system of disclosure
controls and procedures, no evaluation of disclosure controls and procedures can provide absolute assurance that all control issues and
instances of fraud, if any, with a company have been prevented or detected on a timely basis. Even disclosure controls and procedures
determined to be effective can only provide reasonable assurance that their objectives are achieved.
As of June 30, 2023, we carried out an evaluation,
under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer,
of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e))
pursuant to Rule 13a-15 of the Exchange Act. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures are not effective at the reasonable assurance level.
Our size has prevented us from being able to employ
sufficient resources to enable us to have an adequate level of supervision and segregation of duties. Therefore, it is difficult to effectively
segregate accounting duties which comprises a material weakness in internal controls. This lack of segregation of duties leads management
to conclude that the Company’s disclosure controls and procedures are not effective to give reasonable assurance that the information
required to be disclosed in reports that the Company files under the Exchange Act is recorded, processed, summarized and reported as and
when required.
To the extent reasonably possible given our limited
resources, we intend to take measures to cure the aforementioned weaknesses, including, but not limited to, increasing the capacity of
our qualified financial personnel to ensure that accounting policies and procedures are consistent across the organization and that we
have adequate control over our Exchange Act reporting disclosures.
Changes in Internal Control over Financial
Reporting
There have been no changes in our internal control
procedures over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the six months ended June
30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEDINGS
ITEM 1A. RISK FACTORS
As a smaller reporting company as defined by Rule
12b-2 of the Securities Exchange Act of 1934, as amended, and in item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting
obligations and therefore are not required to provide the information requested by this item. In any event, there have been no material
changes in our risk factors as previously disclosed in our Annual Report on Form 10-K filed with the U.S. Securities and Securities Exchange
Commission (“SEC”) on March 10, 2023.
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
(A) Unregistered Sales of Equity Securities
None.
(B) Use of Proceeds
Not applicable.
(C) Issuer Purchases of Equity Securities
None
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
ITEM 5. OTHER INFORMATION
As previously reported by the Company on a Current
Report on Form 8-K filed with the Securities and Exchange Commission on July 21, 2023, on July 20, 2023, the Company received written
notice from The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company failed to maintain a minimum bid price of at least
$1.00 per share for the prior 30 consecutive trading day period from June 6, 2023 to July 19, 2023, based upon the closing bid price for
its common stock as required by Nasdaq Listing Rule 5550(a)(2).
Pursuant to Nasdaq Listing Rule 5810(c)(3)(A),
the Company has 180 calendar days, or until January 16, 2024, to regain compliance with the minimum bid requirement under Nasdaq Listing
Rule 5550(a)(2). During the compliance period, the Company’s common stock will continue to be listed and traded on The Nasdaq Capital
Market. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum
of 10 consecutive trading days, unless extended by Nasdaq under Nasdaq Rule 5810(c)(3)(H), prior to January 16, 2024.
In the event the Company does not regain compliance
during the compliance period, the Company may be eligible for additional 180 calendar days to comply with Nasdaq Listing Rule 5550(a)(2),
subject to the Company satisfying the continued listing requirement for the market value of publicly held shares and all other initial
listing standards for The Nasdaq Capital Market with the exception of the bid price requirement, subject to Nasdaq’s approval.
As previously reported by the Company on a Current
Report on Form 8-K filed with the Securities and Exchange Commission on May 19, 2023, the Company received a written notice from Nasdaq
dated May 17, 2023, notifying the Company that it is no longer in compliance with Nasdaq Rule 5550(b)(1), the minimum stockholders’
equity requirement of $2,500,000 for continued listing on The Nasdaq Capital Market (the “Minimum Equity Requirement”).
On June 16, 2023, the Company consummated a public
offering (the “Public Offering”) of 10,000,000 units, each unit consisting of one share of the Company’s common stock
and two warrants, each to purchase one share of the Company’s common stock in which it received net proceeds of $4,866,000. As of
July 10, 2023, the Company believes it is in compliance with the Minimum Equity Requirement as a result of the Public Offering.
Nasdaq will continue to monitor the Company’s
ongoing compliance with the Minimum Equity Requirement and, if at the time of its next periodic report the Company does not evidence compliance,
it may be subject to delisting.
ITEM 6. EXHIBITS
EXHIBIT INDEX
Exhibit
Number |
|
Description |
|
|
|
3.1# |
|
Second Amended and Restated Certificate of Incorporation of the Registrant. |
|
|
|
3.2# |
|
Bylaws of the Registrant. |
|
|
|
4.1## |
|
Form of Warrant. |
|
|
|
4.2# |
|
Form of Pre-funded Warrant. |
|
|
|
4.3# |
|
Form of Warrant Agency Agreement. |
|
|
|
4.4## |
|
Form of Securities Purchase Agreement |
|
|
|
10.1# |
|
Employment Agreement dated June 1, 2021 between Steven M. Foster and the Registrant. |
|
|
|
10.2# |
|
Employment Agreement dated June 1, 2021 between Richard Ginn and the Registrant. |
|
|
|
10.3# |
|
Consulting Agreement dated May 7, 2021 by and between Richard Ferrari and the Registrant. |
|
|
|
10.4# |
|
Employment Agreement dated June 1, 2021 between Steven Van Dick and the Registrant. |
|
|
|
10.5# |
|
Tenon Medical 2022 Equity Incentive Plan. |
|
|
|
10.6### |
|
Purchase Agreement dated as of July 24, 2023, by and between Tenon Medical, Inc. and Lincoln Park Capital Fund, LLC |
|
|
|
10.7### |
|
Registration Rights Agreement dated as of July 24, 2023, by and between Tenon Medical, Inc. and Lincoln Park Capital Fund, LLC |
|
|
|
21.1# |
|
List of Subsidiaries of the Registrant. |
|
|
|
31.1 |
|
Rule 13a-14(a)/15d-14(a) Certification of the President and Chief Executive Officer of Tenon Medical, Inc. |
|
|
|
31.2 |
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer of Tenon Medical, Inc. |
|
|
|
32.1* |
|
Section 1350 Certification of the President and Chief Executive Officer of Tenon Medical, Inc. |
|
|
|
32.2* |
|
Section 1350 Certification of the Chief Financial Officer of Tenon Medical, Inc. |
|
|
|
101.INS* |
|
Inline XBRL Instance Document |
|
|
|
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
# |
Incorporated by reference to the same exhibit number in the Company’s Registration Statement No. 333-272488, filed with the Securities and Exchange Commission on June 7, 2023. |
## |
Incorporated by reference to the same exhibit number in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 20, 2023, as amended by the Form 8-K/A filed with the Securities and Exchange Commission on July 18, 2023. |
|
### |
Incorporated by reference to the same exhibit number in the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on July 28, 2023. |
|
* |
Exhibits 32.1 and 32.2 are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing. |
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 thereunto duly authorized.
|
TENON MEDICAL, INC. |
|
|
Dated: August 11, 2023 |
/s/ Steven M. Foster |
|
Steven M. Foster |
|
Chief Executive Officer and President, Director
(Principal Executive Officer) |
|
|
Dated: August 11, 2023 |
/s/ Steven Van Dick |
|
Steven Van Dick |
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
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1. I have reviewed this Quarterly Report on Form
10-Q of Tenon Medical, Inc.;
2. Based on my knowledge, this report does not
contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements,
and other financial information included in this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer
and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant
and have:
5. The registrant’s other certifying officer
and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
1. I have reviewed this Quarterly Report on Form
10-Q of Tenon Medical, Inc.;
2. Based on my knowledge, this report does not
contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements,
and other financial information included in this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer
and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant
and have:
5. The registrant’s other certifying officer
and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions)
Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Steven Foster, the Chief Executive Officer of Tenon Medical, Inc. (the “Company”),
hereby certify, that, to my knowledge:
1. The Quarterly Report on
Form 10-Q for the period ended June 30, 2023 (the “Report”) of the Company fully complies with the requirements of Section
13(a) and 15(d) of the Securities Exchange Act of 1934; and
2. The information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Steven Van Dick, the Chief Financial Officer of Tenon Medical, Inc. (the
“Company”), hereby certify, that, to my knowledge:
1. The Quarterly Report on
Form 10-Q for the period ended June 30, 2023 (the “Report”) of the Company fully complies with the requirements of Section
13(a)/15(d) of the Securities Exchange Act of 1934; and
2. The information contained
in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.