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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 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 No. 001-38148
CO-DIAGNOSTICS,
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Utah |
|
46-2609396 |
(State
or other jurisdiction
of incorporation or organization) |
|
(I.R.S.
Employer
Identification Number) |
2401
S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address
of principal executive offices and zip code)
(801)
438-1036
(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 |
|
CODX |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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 and posted pursuant
to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant
was required to submit and post 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 Act). Yes ☐ No ☒
As
of November 8, 2023, there were 30,580,904 shares of common stock, par value $0.001 per share, outstanding.
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
TABLE
OF CONTENTS
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| |
September 30, 2023 | | |
December 31, 2022 | |
Assets | |
| | |
| |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 10,239,898 | | |
$ | 22,973,803 | |
Marketable investment securities | |
| 53,188,999 | | |
| 58,289,066 | |
Accounts receivable, net | |
| 806,704 | | |
| 3,453,723 | |
Inventory, net | |
| 4,520,430 | | |
| 5,310,473 | |
Income taxes receivable | |
| 1,245,854 | | |
| 1,870,419 | |
Prepaid expenses and other current assets | |
| 1,290,146 | | |
| 761,187 | |
Note receivable | |
| 18,750 | | |
| 75,000 | |
Total current assets | |
| 71,310,781 | | |
| 92,733,671 | |
Property and equipment, net | |
| 2,808,339 | | |
| 2,539,483 | |
Deferred tax asset | |
| 4,272,002 | | |
| - | |
Operating lease right-of-use asset | |
| 3,032,337 | | |
| 372,115 | |
Intangible assets, net | |
| 26,479,333 | | |
| 26,768,333 | |
Investment in joint venture | |
| 778,943 | | |
| 672,679 | |
Total assets | |
$ | 108,681,735 | | |
$ | 123,086,281 | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,416,435 | | |
$ | 952,296 | |
Accrued expenses, current | |
| 1,826,639 | | |
| 934,447 | |
Operating lease liability, current | |
| 794,516 | | |
| 297,209 | |
Contingent consideration liabilities, current | |
| 710,651 | | |
| 1,689,471 | |
Deferred revenue | |
| 349,499 | | |
| - | |
Total current liabilities | |
| 5,097,740 | | |
| 3,873,423 | |
Long-term liabilities | |
| | | |
| | |
Income taxes payable | |
| 1,359,725 | | |
| 1,181,284 | |
Deferred tax liability | |
| - | | |
| 2,417,987 | |
Operating lease liability | |
| 2,250,393 | | |
| 50,708 | |
Contingent consideration liabilities | |
| 484,332 | | |
| 1,042,885 | |
Total long-term liabilities | |
| 4,094,450 | | |
| 4,692,864 | |
Total liabilities | |
| 9,192,190 | | |
| 8,566,287 | |
Commitments and contingencies (Note 10) | |
| | | |
| | |
Stockholders’ equity | |
| - | | |
| - | |
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| - | | |
| - | |
Common stock, $0.001 par value; 100,000,000 shares authorized; 35,367,100 shares issued and 30,658,580 shares outstanding as of September 30, 2023 and 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022 | |
| 35,367 | | |
| 34,754 | |
Treasury stock, at cost; 4,708,520 and 3,881,658 shares held as of September 30, 2023 and December 31, 2022, respectively | |
| (15,416,122 | ) | |
| (14,211,866 | ) |
Additional paid-in capital | |
| 94,983,030 | | |
| 88,472,935 | |
Accumulated other comprehensive income | |
| 612,649 | | |
| 293,140 | |
Accumulated earnings | |
| 19,274,621 | | |
| 39,931,031 | |
Total stockholders’ equity | |
| 99,489,545 | | |
| 114,519,994 | |
Total liabilities and stockholders’ equity | |
$ | 108,681,735 | | |
$ | 123,086,281 | |
See
accompanying notes to unaudited condensed consolidated financial statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Product revenue | |
$ | 136,533 | | |
$ | 5,094,456 | | |
$ | 936,296 | | |
$ | 32,816,726 | |
Grant revenue | |
| 2,320,565 | | |
| - | | |
| 2,320,565 | | |
| - | |
Total revenue | |
| 2,457,098 | | |
| 5,094,456 | | |
| 3,256,861 | | |
| 32,816,726 | |
Cost of revenue | |
| 255,772 | | |
| 767,936 | | |
| 1,217,108 | | |
| 4,965,319 | |
Gross profit | |
| 2,201,326 | | |
| 4,326,520 | | |
| 2,039,753 | | |
| 27,851,407 | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 1,904,395 | | |
| 1,889,907 | | |
| 5,343,692 | | |
| 6,014,280 | |
General and administrative | |
| 3,147,753 | | |
| 3,622,273 | | |
| 9,875,613 | | |
| 9,012,888 | |
Research and development | |
| 5,788,789 | | |
| 5,037,461 | | |
| 16,783,892 | | |
| 12,698,632 | |
Depreciation and amortization | |
| 296,340 | | |
| 312,494 | | |
| 917,596 | | |
| 984,100 | |
Total operating expenses | |
| 11,137,277 | | |
| 10,862,135 | | |
| 32,920,793 | | |
| 28,709,900 | |
(Loss) from operations | |
| (8,935,951 | ) | |
| (6,535,615 | ) | |
| (30,881,040 | ) | |
| (858,493 | ) |
Other income, net | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 322,877 | | |
| 298,184 | | |
| 717,141 | | |
| 371,248 | |
Realized gain on investments | |
| 425,446 | | |
| - | | |
| 1,254,718 | | |
| - | |
Gain (loss) on disposition of assets | |
| (2,578 | ) | |
| 4,044 | | |
| (2,578 | ) | |
| (138,117 | ) |
Gain on remeasurement of acquisition contingencies | |
| 140,296 | | |
| 2,886,734 | | |
| 1,537,373 | | |
| 7,079,446 | |
Gain (loss) on equity method investment in joint venture | |
| (45,865 | ) | |
| (129,047 | ) | |
| 106,264 | | |
| (256,911 | ) |
Total other income, net | |
| 840,176 | | |
| 3,059,915 | | |
| 3,612,918 | | |
| 7,055,666 | |
Income tax (benefit) | |
| (2,113,581 | ) | |
| (2,114,638 | ) | |
| (6,611,712 | ) | |
| (1,470,058 | ) |
Net income (loss) | |
$ | (5,982,194 | ) | |
$ | (1,361,062 | ) | |
$ | (20,656,410 | ) | |
$ | 7,667,231 | |
Other comprehensive income (loss) | |
| | | |
| | | |
| | | |
| | |
Change in net unrealized gains on marketable securities, net of tax | |
$ | 33,522 | | |
$ | - | | |
$ | 319,509 | | |
$ | - | |
Total other comprehensive income | |
$ | 33,522 | | |
$ | - | | |
$ | 319,509 | | |
$ | - | |
Comprehensive income (loss) | |
$ | (5,948,672 | ) | |
$ | (1,361,062 | ) | |
$ | (20,336,901 | ) | |
$ | 7,667,231 | |
| |
| | | |
| | | |
| | | |
| | |
Earnings (loss) per common share: | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.24 | |
Diluted | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.23 | |
Weighted average shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 32,109,213 | |
Diluted | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 33,002,539 | |
See
accompanying notes to unaudited condensed consolidated financial statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities | |
| | | |
| | |
Net (loss) income | |
$ | (20,656,410 | ) | |
$ | 7,667,231 | |
Adjustments to reconcile net income to cash (used in) provided by operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 917,596 | | |
| 984,100 | |
Stock-based compensation expense | |
| 6,510,708 | | |
| 5,138,815 | |
Change in fair value of acquisition contingencies | |
| (1,537,373 | ) | |
| (7,079,446 | ) |
Non-cash lease expense | |
| 36,770 | | |
| 17,193 | |
Realized gain on investments | |
| (1,254,718 | ) | |
| - | |
(Gain) loss from equity method investment | |
| (106,264 | ) | |
| 256,911 | |
Loss on disposition of assets | |
| 2,578 | | |
| 138,117 | |
Deferred income taxes | |
| (6,689,989 | ) | |
| (3,431,286 | ) |
Bad debt expense | |
| 326,647 | | |
| 338,057 | |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 2,320,372 | | |
| 12,539,461 | |
Prepaid expenses and other assets | |
| 151,858 | | |
| 441,786 | |
Inventory | |
| 790,716 | | |
| (3,656,463 | ) |
Deferred revenue | |
| 349,499 | | |
| (150,000 | ) |
Income taxes payable | |
| 178,441 | | |
| (1,822,977 | ) |
Accounts payable, accrued expenses and other liabilities | |
| 1,356,330 | | |
| (802,955 | ) |
Net cash (used in) provided by operating activities | |
| (17,303,239 | ) | |
| 10,578,544 | |
Cash flows from investing activities | |
| | | |
| | |
Purchases of property and equipment | |
| (900,704 | ) | |
| (1,134,208 | ) |
Proceeds from maturities of marketable investment securities | |
| 90,279,227 | | |
| 6,223,740 | |
Net cash (used in) provided by investing activities | |
| 5,773,590 | | |
| (4,861,292 | ) |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from exercise of options and warrants | |
| - | | |
| 177,870 | |
Repurchases of common stock | |
| (1,204,256 | ) | |
| (12,994,373 | ) |
Net cash (used in) financing activities | |
| (1,204,256 | ) | |
| (12,816,503 | ) |
Net (decrease) in cash and cash equivalents | |
| (12,733,905 | ) | |
| (7,099,251 | ) |
Cash and cash equivalents at beginning of period | |
| 22,973,803 | | |
| 88,607,234 | |
Cash and cash equivalents at end of period | |
$ | 10,239,898 | | |
$ | 81,507,983 | |
Supplemental disclosure of cash flow information | |
| | | |
| | |
Interest paid | |
$ | - | | |
$ | - | |
Income taxes paid | |
$ | 49,197 | | |
$ | 4,496,239 | |
Supplemental disclosure of non-cash investing and financing transactions | |
| | | |
| | |
Inventory moved to property, plant and equipment | |
$ | 673 | | |
$ | 218,906 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | |
$ | 3,063,782 | | |
$ | 681,327 | |
Business acquisition measurement period adjustments | |
$ | - | | |
$ | 681,728 | |
See
accompanying notes to unaudited condensed consolidated financial statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Stock | | |
Capital | | |
Income | | |
Earnings | | |
Equity | |
| |
Convertible Preferred
Stock | | |
Common Stock | | |
Treasury | | |
Additional Paid-in | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Stock | | |
Capital | | |
Income | | |
Earnings | | |
Equity | |
Balance as of December 31, 2022 | |
| - | | |
$ | - | | |
| 34,754,265 | | |
$ | 34,754 | | |
$ | (14,211,866 | ) | |
$ | 88,472,935 | | |
$ | 293,140 | | |
$ | 39,931,031 | | |
$ | 114,519,994 | |
Stock-based compensation | |
| - | | |
| - | | |
| 68,750 | | |
| 69 | | |
| - | | |
| 2,168,673 | | |
| - | | |
| - | | |
| 2,168,742 | |
Repurchases of common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| (482,196 | ) | |
| - | | |
| - | | |
| - | | |
| (482,196 | ) |
Other comprehensive income, net of tax | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 178,621 | | |
| - | | |
| 178,621 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,755,391 | ) | |
| (5,755,391 | ) |
Balance as of March 31, 2023 | |
| - | | |
| - | | |
| 34,823,015 | | |
| 34,823 | | |
| (14,694,062 | ) | |
| 90,641,608 | | |
| 471,761 | | |
| 34,175,640 | | |
| 110,629,770 | |
Stock-based compensation | |
| - | | |
| - | | |
| 525,335 | | |
| 525 | | |
| - | | |
| 2,169,276 | | |
| - | | |
| - | | |
| 2,169,801 | |
Repurchases of common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| (555,734 | ) | |
| - | | |
| - | | |
| - | | |
| (555,734 | ) |
Other comprehensive income, net of tax | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 107,366 | | |
| - | | |
| 107,366 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,918,825 | ) | |
| (8,918,825 | ) |
Balance as of June 30, 2023 | |
| - | | |
| - | | |
| 35,348,350 | | |
| 35,348 | | |
| (15,249,796 | ) | |
| 92,810,884 | | |
| 579,127 | | |
| 25,256,815 | | |
| 103,432,378 | |
Balance | |
| - | | |
| - | | |
| 35,348,350 | | |
| 35,348 | | |
| (15,249,796 | ) | |
| 92,810,884 | | |
| 579,127 | | |
| 25,256,815 | | |
| 103,432,378 | |
Stock-based compensation | |
| - | | |
| - | | |
| 18,750 | | |
| 19 | | |
| - | | |
| 2,172,146 | | |
| - | | |
| - | | |
| 2,172,165 | |
Repurchases of common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| (166,326 | ) | |
| - | | |
| - | | |
| - | | |
| (166,326 | ) |
Other comprehensive income, net of tax | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 33,522 | | |
| - | | |
| 33,522 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,982,194 | ) | |
| (5,982,194 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,982,194 | ) | |
| (5,982,194 | ) |
Balance as of September 30, 2023 | |
| - | | |
$ | - | | |
| 35,367,100 | | |
$ | 35,367 | | |
$ | (15,416,122 | ) | |
$ | 94,983,030 | | |
$ | 612,649 | | |
$ | 19,274,621 | | |
$ | 99,489,545 | |
Balance | |
| - | | |
$ | - | | |
| 35,367,100 | | |
$ | 35,367 | | |
$ | (15,416,122 | ) | |
$ | 94,983,030 | | |
$ | 612,649 | | |
$ | 19,274,621 | | |
$ | 99,489,545 | |
| |
Convertible Preferred
Stock | | |
Common
Stock | | |
Treasury | | |
Additional Paid-in | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Stock | | |
Capital | | |
Income | | |
Earnings | | |
Equity | |
Balance as of December 31, 2021 | |
| - | | |
$ | - | | |
| 33,819,862 | | |
$ | 33,820 | | |
$ | - | | |
$ | 80,271,999 | | |
$ | - | | |
$ | 54,169,279 | | |
$ | 134,475,100 | |
Common stock issued for option exercises | |
| - | | |
| - | | |
| 45,456 | | |
| 45 | | |
| - | | |
| 49,956 | | |
| - | | |
| - | | |
| 50,001 | |
Common stock issued for warrant exercises | |
| - | | |
| - | | |
| 50,000 | | |
| 50 | | |
| - | | |
| 99,950 | | |
| - | | |
| | | |
| 100,000 | |
Stock-based compensation | |
| - | | |
| - | | |
| 68,750 | | |
| 69 | | |
| - | | |
| 1,375,028 | | |
| - | | |
| - | | |
| 1,375,097 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 11,714,595 | | |
| 11,714,595 | |
Balance as of March 31, 2022 | |
| - | | |
| - | | |
| 33,984,068 | | |
| 33,984 | | |
| - | | |
| 81,796,933 | | |
| - | | |
| 65,883,874 | | |
| 147,714,793 | |
Common stock issued for option exercises | |
| - | | |
| - | | |
| 25,335 | | |
| 25 | | |
| - | | |
| 27,844 | | |
| - | | |
| - | | |
| 27,869 | |
Stock-based compensation | |
| - | | |
| - | | |
| 215,583 | | |
| 215 | | |
| - | | |
| 1,533,069 | | |
| - | | |
| - | | |
| 1,533,284 | |
Common stock issued for acquisitions | |
| - | | |
| - | | |
| 88,446 | | |
| 89 | | |
| - | | |
| 480,687 | | |
| - | | |
| - | | |
| 480,776 | |
Repurchases of common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,599,478 | ) | |
| - | | |
| - | | |
| - | | |
| (2,599,478 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,686,304 | ) | |
| (2,686,304 | ) |
Balance as of June 30, 2022 | |
| - | | |
| - | | |
| 34,313,432 | | |
| 34,313 | | |
| (2,599,478 | ) | |
| 83,838,533 | | |
| - | | |
| 63,197,570 | | |
| 144,470,940 | |
Balance | |
| - | | |
| - | | |
| 34,313,432 | | |
| 34,313 | | |
| (2,599,478 | ) | |
| 83,838,533 | | |
| - | | |
| 63,197,570 | | |
| 144,470,940 | |
Stock-based compensation | |
| - | | |
| - | | |
| 18,750 | | |
| 19 | | |
| - | | |
| 2,230,415 | | |
| - | | |
| - | | |
| 2,230,434 | |
Repurchases of common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,394,895 | ) | |
| - | | |
| - | | |
| - | | |
| (10,394,895 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,361,062 | ) | |
| (1,361,062 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,361,062 | ) | |
| (1,361,062 | ) |
Balance as of September 30, 2022 | |
| - | | |
$ | - | | |
| 34,332,182 | | |
$ | 34,332 | | |
$ | (12,994,373 | ) | |
$ | 86,068,948 | | |
$ | - | | |
$ | 61,836,508 | | |
$ | 134,945,417 | |
Balance | |
| - | | |
$ | - | | |
| 34,332,182 | | |
$ | 34,332 | | |
$ | (12,994,373 | ) | |
$ | 86,068,948 | | |
$ | - | | |
$ | 61,836,508 | | |
$ | 134,945,417 | |
See
accompanying notes to unaudited condensed consolidated financial statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note
1 – Overview and Basis of Presentation
Description
of Business
Co-Diagnostics,
Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic
tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including robust and innovative molecular
tools for detection of infectious diseases and agricultural applications. In connection with the sale of our tests we may sell diagnostic
equipment from other manufacturers as self-contained lab systems (which we refer to as the “MDx Device”). We are also developing
a unique, groundbreaking portable PCR device and proprietary test cups (the “Co-Dx™ PCR platform”) that have been designed
to bring affordable, reliable polymerase chain reaction (“PCR”) to patients in point-of-care and at-home settings. This platform
is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing.
There is no guarantee the Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory
approval is received, we will be able to successfully commercialize this platform.
Unaudited
Condensed Consolidated Financial Statements
The
accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q as they are
prescribed for smaller reporting companies. Accordingly, they do not include all the information and footnotes required by accounting
principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary to make the financial statements not misleading have been included. Operating
results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for
the year ending December 31, 2023. These statements should be read in conjunction with the Company’s audited financial statements
and related notes for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission (the “SEC”) on March 16, 2023.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include receivables
and other long-lived assets, legal contingencies, income taxes, share based arrangements, and others. These estimates and assumptions
are based on management’s best estimates and judgments. Actual amounts and results could differ from those estimates.
Note
2 – Summary of Significant Accounting Policies
Reclassifications
Certain
prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact
on the previously reported results.
Cash
and Cash Equivalents
Cash
and cash equivalents consist of cash on hand, money market funds and highly liquid investments with an original maturity date of 90 days
or less from the date of purchase. The fair value of cash equivalents approximated their carrying value as of September 30, 2023 and
December 31, 2022. The Company has its cash and cash equivalents with large creditworthy financial
institutions and the balance exceeded federally insured limits. The Company has not experienced any losses in such accounts, and management
believes the Company is not exposed to any significant credit risk on cash and cash equivalents.
Marketable
Investment Securities
The
Company’s marketable investment securities are comprised of investments in certificates of deposit and U.S. Treasury bills and
notes. The Company designates investments in debt securities as available-for-sale. Available-for-sale debt securities with original
maturities of three months or less from the date of purchase are classified within cash and cash equivalents. Available-for-sale debt
securities with original maturities longer than three months are available to fund current operations and are classified as marketable
investment securities, within current assets on the condensed consolidated balance sheets. The Company may sell these securities at any
time for use in its current operations or for other purposes, even prior to maturity. Available-for-sale debt securities are reported
at fair value with the related unrealized gains and losses included in accumulated other comprehensive income (loss), a component of
stockholders’ equity, net of tax. Realized gains and losses on the sale of marketable investment securities are determined using
the average cost method on a first-in, first-out basis and recorded in total other income (expense), net in the condensed consolidated
statements of operations and comprehensive income (loss).
The
available-for-sale debt securities are subject to a periodic impairment review. For investments in an unrealized loss position, the Company
writes down the amortized cost basis of the investment if it is more likely than not that the Company will be required or will intend
to sell the investment before recovery of its amortized cost basis. For investments not likely to be sold before recovery of the amortized
cost basis, the Company determines whether a credit loss exists by considering information about the collectability of the instrument,
current market conditions, and reasonable and supportable forecasts of economic conditions. The Company recognizes an allowance for credit
losses up to the amount of the unrealized loss when appropriate. Allowances for credit losses and write-downs are recognized in total
other income (expense), net, and unrealized losses not related to credit losses are recognized in accumulated other comprehensive income
(loss). There are no allowances for credit losses recorded for the periods presented.
Accounts
Receivable
Trade
accounts receivable are recorded at the invoiced amount less estimates for credit losses. Management determines the allowance for credit
losses by specifically identifying troubled accounts and by using historical write off experience, adjusted for current market conditions,
customers’ financial condition and payment patterns, and reasonable supportable forecasts of future economic conditions, applied
to an aging of all other accounts. Account balances are written off against the allowance once the receivable is deemed uncollectible.
Recoveries of trade receivables previously written off are recorded when collected. At September 30, 2023, total accounts receivable
was $4,231,877 with an allowance for credit losses of $3,425,173 resulting in a net amount of $806,704. At December 31, 2022, total accounts
receivable was $6,552,249 with an allowance for credit losses of $3,098,526 resulting in a net amount of $3,453,723.
Equity-Method
Investments
The
Company’s equity method investments are initially recorded at cost and are included in other long-term assets in the accompanying
condensed consolidated balance sheet. The Company adjusts the carrying value of its investment based on our share of the earnings or
losses in the periods which they are reported by the investee until the carrying amount is zero. The earnings or losses are included
in other income (expense) in the accompanying condensed consolidated statements of operations.
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At September 30, 2023, the Company had $4,520,430 in inventory, comprised of $788,104
of finished goods, and $3,732,326 of raw materials. At December 31, 2022, the Company had $5,310,473 in inventory, of which $1,327,264
was finished goods and $3,983,209 was raw materials. The Company establishes reserves to reduce slow-moving, obsolete, or unusable inventories
to their estimated useful or scrap values.
Intangible
Assets
Indefinite-lived
intangible assets are not amortized, but rather tested for impairment at least annually on December 31, or more often if and when circumstances
indicate that the carrying value may not be recoverable. Finite-lived intangible assets are amortized over their useful lives.
Long-lived
Assets
Long-lived
assets, such as property and equipment, are stated at cost less accumulated depreciation and amortization. Depreciation is provided using
the straight-line method over the estimated useful lives of the property, generally from three to five years. Repairs and maintenance
costs are expensed as incurred except when such repairs significantly add to the useful life or productive capacity of the asset, in
which case the repairs are capitalized.
The
Company reviews its long-lived assets, including property and equipment, finite-lived intangible assets, and right-of-use (ROU) assets,
for impairment whenever an event or change in facts and circumstances indicates that their carrying amounts may not be recoverable. Recoverability
of these assets is measured by comparing the carrying amount to the estimated undiscounted future cash flows expected to be generated.
If the carrying amount exceeds the undiscounted cash flows, the assets are determined to be impaired and an impairment charge is recognized
as the amount by which the carrying amount exceeds fair value.
Business
Combinations
The
Company estimates the fair value of assets acquired and liabilities assumed in a business combination. Goodwill as of the acquisition
date is measured as the excess of consideration transferred over the net of the acquisition date fair values of the assets acquired and
the liabilities assumed. Such valuations require management to make significant estimates and assumptions, especially with respect to
intangible assets. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently
uncertain and unpredictable, and as a result, actual results may differ from estimates.
Leases
The
Company adopted ASC 842, Leases (“ASC 842”) effective January 1, 2022. Under ASC 842, the Company determines if an arrangement
is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to
control the identified asset. Right-of-use (ROU) assets represent the Company’s right to use an underlying asset for the lease
term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities
are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are
based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude
lease incentives and initial direct costs incurred, as applicable.
As
the implicit rate in the Company’s leases is generally unknown, the Company uses its incremental borrowing rate based on the information
available at the lease commencement date in determining the present value of future lease payments. The Company considers its credit
risk, term of the lease, total lease payments and adjusts for the impacts of collateral, as necessary, when calculating its incremental
borrowing rates. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it
is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. Lease costs for
the Company’s operating leases are recognized on a straight-line basis within operating expenses and cost of revenue over the reasonably
assured lease term.
The
Company has elected to not separate lease and non-lease components for leases of office space and, as a result, accounts for any lease
and non-lease components for office space as a single lease component, to the extent they are fixed. Non-lease components that are not
fixed are expensed as incurred as variable lease payments. The Company’s office leases typically include non-lease components such
as common-area maintenance costs. The Company has also elected to not apply the recognition requirement to any leases within its existing
classes of assets with a term of 12 months or less.
Revenue
Recognition
The
Company generates revenue from customers from product and license sales. The Company recognizes revenue from customers when all of the
following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether
the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii)
measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to
the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.
The
Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company
records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.
Grant
Funding
The
Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for grants
by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”). Revenues from
grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms of the specific
agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue in the condensed
consolidated statements of operations and comprehensive income (loss).
The
Company recognizes grant funding with conditions or continuing performance obligations as deferred revenue in the condensed consolidated
balance sheets if the conditions or performance obligations have not yet been met.
The
Company recognized grant funding revenue of $2.3 million during the three and nine months ended September 30, 2023. At September 30,
2023, the Company has also recorded $0.3 million of deferred revenue related to grant funding for which the underlying conditions or
performance obligations have not yet been met. Cash received from federal grants, contracts, and awards can be subject to audit by the
grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.
Deferred
Revenue
Deferred
revenue primarily consists of payments received from customers related to product sales or from granting agencies for services to be
rendered under research and development grants, prior to the Company fulfilling its performance obligation of providing the product or
performing research and development activities under the grant agreement. When this occurs, the Company records a contract liability
as deferred revenue. Deferred revenue is recognized as revenue as the related performance obligations are satisfied.
Research
and Development
Research
and development costs are expensed when incurred. For the three and nine months ended September 30, 2023, the Company expensed $5,788,789
and $16,783,892 of research and development costs, respectively. For the three and nine months ended September 30, 2022, the Company
expensed $5,037,461 and $12,698,632, respectively.
Stock-based
Compensation
The
Company has granted stock-based awards, including restricted stock, stock options, stock warrants and restricted stock units (“RSUs”),
to its employees, certain consultants and members of its board of directors. The Company records stock-based compensation based on the
grant date fair value of the awards and recognizes the fair value of those awards as expense using the straight-line method over the
requisite service period of the award. The Company estimates the grant date fair value of stock options using the Black-Scholes option-pricing
model. When an award is forfeited prior to the vesting date, the Company recognizes an adjustment
for the previously recognized expense in the period of the forfeiture.
Income
Taxes
The
Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred
income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and
tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes
only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the
taxing authority.
Valuation
allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing
the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income
and ongoing tax planning strategies.
Developing
the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant
judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income
tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and
tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the condensed consolidated
financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the condensed consolidated
financial positions, result of operations, or cash flows.
Net
Income (Loss) per Share
Basic
net income or loss per common share is computed by dividing net income or loss applicable to common shareholders by the weighted average
number of shares outstanding during each period.
Diluted
net income or loss per share is computed by dividing net income or loss attributable to common stockholders by the weighted-average number
of shares of common stock outstanding during the period increased by common shares that could be issued upon conversion or exercise of
other outstanding securities to the extent those additional common shares would be dilutive. The dilutive effect of potentially dilutive
securities is reflected in diluted net income or loss per share by application of the treasury stock method. During periods when the
Company is in a net loss position, basic net loss per share is the same as diluted net loss per share as the effects of potentially dilutive
securities are anti-dilutive.
Comprehensive
Income (Loss)
Comprehensive
income is comprised of unrealized gains and losses on marketable investment securities, net of income taxes.
Concentrations
Risk and Significant Customers
The
Company had certain customers which were each responsible for generating 10% or more of the total revenue for the three and nine months
ended September 30, 2023. Three customers accounted for approximately 47% of product revenue for the three months ended September 30,
2023, and two customers accounted for approximately 28% of product revenue for the nine months ended September 30, 2023. One granting
agency accounted for approximately 94% of grant revenue for the three and nine months ended September 30, 2023. One customer accounted
for approximately 52% of product revenue for the three months ended September 30, 2022, and two customers accounted for approximately
47% of product revenue for the nine months ended September 30, 2022.
Two
customers accounted for more than 10% of accounts receivable at September 30, 2023 and three customers accounted for more than 10% of
accounts receivable at December 31, 2022. These customers together accounted for approximately 71% and 37% of accounts receivable at
September 30, 2023 and December 31, 2022, respectively.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted
by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards,
which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
Note
3 - Cash, Cash Equivalents, and Financial Instruments
The
following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:
Schedule
of Cash, Cash Equivalents and Marketable Investment Securities
| |
September 30, 2023 | |
| |
Adjusted Cost | | |
Allowance for Credit Losses | | |
Total Unrealized Gains / (Losses) | | |
Fair
Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash and cash equivalents | |
$ | (222,480 | ) | |
$ | - | | |
$ | - | | |
$ | (222,480 | ) | |
$ | (222,480 | ) | |
$ | - | |
Level 1: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 10,462,378 | | |
| - | | |
| - | | |
| 10,462,378 | | |
| 10,462,378 | | |
| - | |
Subtotal | |
| 10,462,378 | | |
| - | | |
| - | | |
| 10,462,378 | | |
| 10,462,378 | | |
| - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 52,375,675 | | |
| - | | |
| 813,324 | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Subtotal | |
| 52,375,675 | | |
| - | | |
| 813,324 | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Total | |
$ | 62,615,573 | | |
$ | - | | |
$ | 813,324 | | |
$ | 63,428,897 | | |
$ | 10,239,898 | | |
$ | 53,188,999 | |
| |
December 31, 2022 | |
| |
Adjusted Cost | | |
Allowance for Credit Losses | | |
Total Unrealized Gains / (Losses) | | |
Fair
Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash and cash equivalents | |
$ | 12,834,444 | | |
$ | - | | |
$ | - | | |
$ | 12,834,444 | | |
$ | 12,834,444 | | |
$ | - | |
Level 1: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 146,359 | | |
| - | | |
| - | | |
| 146,359 | | |
| 146,359 | | |
| - | |
Subtotal | |
| 146,359 | | |
| - | | |
| - | | |
| 146,359 | | |
| 146,359 | | |
| - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 67,892,825 | | |
| - | | |
| 389,241 | | |
| 68,282,066 | | |
| 9,993,000 | | |
| 58,289,066 | |
Subtotal | |
| 67,892,825 | | |
| - | | |
| 389,241 | | |
| 68,282,066 | | |
| 9,993,000 | | |
| 58,289,066 | |
Total | |
$ | 80,873,628 | | |
$ | - | | |
$ | 389,241 | | |
$ | 81,262,869 | | |
$ | 22,973,803 | | |
$ | 58,289,066 | |
Marketable
investment securities held as of September 30, 2023 mature over the next 12 months.
Note 4 – Intangible Assets, Net
Intangible assets, net consisted of the following:
Schedule
of Intangible Assets, Net
| |
September 30, 2023 | |
| |
| Weighted-Average Useful Life (1) (in Years) | | |
| Gross Carrying Amount | | |
| Accumulated Amortization | | |
| Net
Carrying Amount | |
In-process research and development | |
| Indefinite | | |
$ | 26,101,000 | | |
$ | - | | |
$ | 26,101,000 | |
Non-competition agreements | |
| 2.7 | | |
| 1,094,000 | | |
| (715,667 | ) | |
| 378,333 | |
Total intangible assets | |
| | | |
$ | 27,195,000 | | |
$ | (715,667 | ) | |
$ | 26,479,333 | |
| |
December 31, 2022 | |
| |
Weighted-Average | | |
Gross | | |
| | |
Net | |
| |
Useful Life (1) | | |
Carrying | | |
Accumulated | | |
Carrying | |
| |
(in Years) | | |
Amount | | |
Amortization | | |
Amount | |
In-process research and development | |
| Indefinite | | |
$ | 26,101,000 | | |
$ | - | | |
$ | 26,101,000 | |
Non-competition agreements | |
| 2.7 | | |
| 1,094,000 | | |
| (426,667 | ) | |
| 667,333 | |
Total intangible assets | |
| | | |
$ | 27,195,000 | | |
$ | (426,667 | ) | |
$ | 26,768,333 | |
The expected future annual amortization expense of the Company’s
intangible assets held as of September 30, 2023 is as follows:
Schedule
of Future Amortization Expense
Year Ending December 31, | |
Amortization Expense | |
2023 (remainder) | |
| 75,665 | |
2024 | |
| 302,668 | |
Total | |
$ | 378,333 | |
Note 5 – Fair Value Measurements
The Company measures and records certain financial
assets and liabilities at fair value on a recurring basis. Fair value is based on the price that would be received from selling an asset
or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
The following three levels of inputs are used to measure
the fair value of financial assets and liabilities:
Level 1: Quoted market prices
in active markets for identical assets or liabilities.
Level 2: Observable market-based
inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs
that are not corroborated by market data.
The following table summarizes the assets and liabilities
measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022, by level within the fair value hierarchy:
Schedule
of Fair Value Assets and Liabilities
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
September 30, 2023 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents | |
$ | 9,722,890 | | |
$ | - | | |
$ | - | | |
$ | 9,722,890 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Total assets measured at fair value | |
$ | 9,722,890 | | |
$ | 53,188,999 | | |
$ | - | | |
$ | 62,911,889 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 1,051,229 | | |
$ | 1,051,229 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| 143,754 | | |
| 143,754 | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 1,194,983 | | |
$ | 1,194,983 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
December 31, 2022 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents | |
$ | 186,667 | | |
$ | 9,993,000 | | |
$ | - | | |
$ | 10,179,667 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 58,289,066 | | |
| - | | |
| 58,289,066 | |
Total assets measured at fair value | |
$ | 186,667 | | |
$ | 68,282,066 | | |
$ | - | | |
$ | 68,468,733 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 2,499,147 | | |
$ | 2,499,147 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| 233,209 | | |
| 233,209 | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 2,732,356 | | |
$ | 2,732,356 | |
The Company’s financial instruments that are
measured at fair value on a recurring basis consist of U.S. treasury bills and notes as of September 30, 2023 and December 31, 2022.
In connection with the acquisitions of Idaho Molecular,
Inc. (IdMo) and Advanced Conceptions, Inc. (ACI) on December 31, 2021, the Company recorded a liability for contingent consideration in
the form of shares of common stock and warrants to purchase common stock. The fair value of contingent consideration is calculated using
a discounted probability weighted valuation model. Discount rates used in such calculations are a significant assumption that are not
observed in the market, and therefore, the resulting fair value represents a Level 3 measurement.
The changes for Level 3 items measured at fair value
on a recurring basis are as follows:
Schedule
of Changes in the Fair Value Measurement
| |
| | |
Fair value as of December 31, 2022 | |
$ | 2,732,356 | |
Change in fair value of contingent consideration issued for business acquisitions | |
| (1,537,373 | ) |
Fair value as of September 30, 2023 | |
$ | 1,194,983 | |
The fair value of the contingent consideration is
based on the fair value of the contingent consideration-common stock and contingent consideration-warrants. The fair value of the contingent
consideration-common stock is equal to the probability-adjusted value of the Company’s common stock as of the valuation date. The
fair value of the contingent consideration-warrants is equal to the probability adjusted value of a call option with terms consistent
with the terms of the warrants as of the valuation date. Prior to the probability adjustments, the warrants were valued based on the following
inputs:
Schedule
of Contingent Consideration Common Stock and Warrants
| |
September 30, 2023 | | |
December 31, 2022 | |
Stock price | |
$ | 1.06 | | |
$ | 2.52 | |
Strike price | |
$ | 9.13 | | |
$ | 9.13 | |
Volatility | |
| 125.00 | % | |
| 75.00 | % |
Risk-free rate | |
| 4.70 | % | |
| 4.10 | % |
Expected term (years) | |
| 3.3 | | |
| 4.0 | |
Fair Value of Other Financial Instruments
The carrying amounts of certain financial instruments,
including cash held in banks, accounts receivable, notes receivable, accounts payable, accrued liabilities, and other liabilities approximate
fair value due to their short-term maturities and are excluded from the fair value tables above.
Note 6 – Revenue
The following table sets forth revenue by geographic
area:
Summary
of Revenue by Geographic Area
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
United States | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
$ | 88,107 | | |
$ | 4,699,444 | | |
$ | 618,491 | | |
$ | 23,425,186 | |
Grant revenue | |
| 2,320,565 | | |
| - | | |
| 2,320,565 | | |
| - | |
Total United States | |
| 2,408,672 | | |
| 4,699,444 | | |
| 2,939,056 | | |
| 23,425,186 | |
Rest of World | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
| 48,426 | | |
| 395,012 | | |
| 317,805 | | |
| 9,391,540 | |
Grant revenue | |
| - | | |
| - | | |
| - | | |
| - | |
Total Rest of World | |
| 48,426 | | |
| 395,012 | | |
| 317,805 | | |
| 9,391,540 | |
Total | |
$ | 2,457,098 | | |
$ | 5,094,456 | | |
$ | 3,256,861 | | |
$ | 32,816,726 | |
Revenue geographic area | |
$ | 2,457,098 | | |
$ | 5,094,456 | | |
$ | 3,256,861 | | |
$ | 32,816,726 | |
Percentage of revenue by area: | |
| | | |
| | | |
| | | |
| | |
United States | |
| 98 | % | |
| 92 | % | |
| 90 | % | |
| 71 | % |
Rest of World | |
| 2 | % | |
| 8 | % | |
| 10 | % | |
| 29 | % |
Deferred Revenue
Changes in the Company’s deferred revenue balance
for the nine months ended September 30, 2023 were as follows:
Schedule
of Deferred Revenue
Balance as of December 31, 2022 | |
$ | - | |
Increase due to prepayments from customers | |
| 19,620 | |
Increase due to grant funding awarded | |
| 329,879 | |
Balance as of September 30, 2023 | |
$ | 349,499 | |
Note 7 – Earnings (Loss) Per Share
The following table reconciles the numerator and the
denominator used to calculate basic and diluted earnings (loss) per share for three and nine months ended September 30, 2023 and 2022,
respectively:
Schedule
of Basis and Diluted Earnings Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net income (loss), as reported | |
$ | (5,982,194 | ) | |
$ | (1,361,062 | ) | |
$ | (20,656,410 | ) | |
$ | 7,667,231 | |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average shares, basic | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 32,109,213 | |
Dilutive effect of stock options, warrants and RSUs | |
| - | | |
| - | | |
| - | | |
| 893,326 | |
Shares used to compute diluted earnings per share | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 33,002,539 | |
| |
| | | |
| | | |
| | | |
| | |
Basic earnings (loss) per share | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.24 | |
Diluted earnings (loss) per share | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.23 | |
For the three and nine months ended September 30,
2022, potentially dilutive securities of 2,631,642 and 1,385,869 were excluded from the calculation because their effect would have been
anti-dilutive. The computation of basic and diluted earnings (loss) per share for the three and nine months ended September 30, 2023 and
2022, respectively, also excludes the approximately 1,400,000 shares of common stock and approximately 465,000 warrants to purchase shares
of common stock that are contingent upon the achievement of certain milestones.
As a result of incurring a net loss for the three
and nine months ended September 30, 2023, no potentially dilutive securities are included in the calculation of diluted earnings (loss)
per share because such effect would be anti-dilutive. The Company had potentially dilutive securities as of September 30, 2023, consisting
of: (i) 2,750,302 restricted stock units and (ii) 512,112 options.
Note 8 – Stock-Based Compensation
Stock Incentive Plans
The Company’s board of directors adopted, and
shareholders approved, the Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive Plan (the “Incentive Plan”)
providing for the issuance of stock-based incentive awards to employees, officers, consultants, directors and independent contractors.
On August 31, 2022, the shareholders approved an increase in the number of awards available for issuance under the Incentive Plan to an
aggregate of 12,000,000 shares of common stock. The number of awards available for issuance under the Incentive Plan was 4,361,861 at
September 30, 2023.
Stock Options
The following table summarizes option activity during
the nine months ended September 30, 2023:
Schedule
of Option Activity
| |
Number of Options | | |
Weighted Average Exercise Price | | |
Weighted Average Fair Value | | |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding at December 31, 2022 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.88 | |
Granted | |
| - | | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| - | | |
| | |
Forfeited/Cancelled | |
| - | | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| - | | |
| | |
Outstanding at September 30, 2023 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.13 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at September 30, 2023 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.13 | |
The aggregate intrinsic value of outstanding options
at September 30, 2023 was approximately $0.1 million.
Stock-based compensation cost is measured at the grant
date based on the fair value of the award granted and recognized as expense over the vesting period using the straight-line method. The
Company uses the Black-Scholes model to value options granted. As of September 30, 2023, there were no unvested options and no unrecognized
stock-based compensation expense related to options.
Restricted Stock Units
The grant date fair value of RSUs granted is determined
using the closing market price of the Company’s common stock on the grant date with the associated compensation expense amortized
over the vesting period of the awards. The following table sets forth the outstanding RSUs and related activity for the nine months ended
September 30, 2023:
Schedule
of Outstanding Restricted Stock Units and Related Party
| |
Number of RSUs | | |
Weighted Average Grant Date Fair Value | |
Unvested at December 31, 2022 | |
| 2,426,725 | | |
$ | 6.95 | |
Granted | |
| 1,918,750 | | |
| 1.93 | |
Vested | |
| (612,835 | ) | |
| 7.24 | |
Forfeited/Cancelled | |
| (69,821 | ) | |
| 6.20 | |
Unvested at September 30, 2023 | |
| 3,662,819 | | |
$ | 4.29 | |
As of September 30, 2023, there was approximately
$11.5 million of unrecognized stock-based compensation expense related to outstanding RSUs which is expected to be recognized over a weighted-average
period of 1.9 years.
Warrants
The Company has issued warrants related to financings,
acquisitions and as compensation to third parties for services provided. The Company estimates the fair value of issued warrants on the
date of issuance as determined using a Black-Scholes pricing model. The Company amortizes the fair value of issued warrants using a vesting
schedule based on the terms and conditions of each warrant if granted for services.
The following table summarizes warrant activity during
the nine months ended September 30, 2023:
Schedule
of Warrant Activity
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Weighted Average Fair Value | | |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding at December 31, 2022 | |
| 485,000 | | |
$ | 8.81 | | |
$ | 2.43 | | |
| 4.0 | |
Granted | |
| - | | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| - | | |
| | |
Forfeited/Cancelled | |
| - | | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| - | | |
| | |
Outstanding at September 30, 2023 | |
| 485,000 | | |
$ | 8.81 | | |
$ | 0.92 | | |
| 3.2 | |
There were no warrants exercised during the nine months
ended September 30, 2023. The intrinsic value of warrants exercised during the nine months ended September 30, 2022 was approximately
$0.3 million. The aggregate intrinsic value of outstanding warrants at September 30, 2023 was approximately $0.
The total number of warrants exercisable at September
30, 2023 is 20,000. The ability to exercise the approximately 465,000 warrants issued in connection with acquisitions in prior years is
contingent upon the achievement of certain development and revenue milestones on or before January 1, 2027. There was no unrecognized
stock-based compensation expense related to warrants.
Stock-Based Compensation Expense
The Company recognized stock-based compensation expense
as follows:
Schedule
of Recognized Stock-based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of revenue | |
$ | 12,075 | | |
$ | 18,836 | | |
$ | 36,140 | | |
$ | 45,290 | |
Sales and marketing | |
| 564,962 | | |
| 526,159 | | |
| 1,666,868 | | |
| 1,340,716 | |
General and administrative | |
| 1,278,674 | | |
| 1,218,211 | | |
| 3,732,398 | | |
| 2,831,371 | |
Research and development | |
| 316,454 | | |
| 467,228 | | |
| 1,075,302 | | |
| 921,438 | |
Total stock-based compensation expense | |
$ | 2,172,165 | | |
$ | 2,230,434 | | |
$ | 6,510,708 | | |
$ | 5,138,815 | |
Note 9 – Income Taxes
For the three months ended September 30, 2023, the
Company recognized a benefit from income taxes of $2,113,581, representing an effective tax rate of 26.1%. For the nine months ended September
30, 2023, the Company recognized a benefit from income taxes of $6,611,712, representing an effective tax rate of 24.2%. The Company’s
effective tax rate will generally differ from the U.S. Federal statutory rate of 21.0% due to state taxes, permanent items, and discrete
items. For the three months ended September 30, 2022, the Company recognized a benefit from income taxes of $2,114,638. For the nine months
ended September 30, 2022, the Company recognized a benefit from income taxes of $1,470,058.
Note 10 – Commitments and Contingencies
Lease Obligations
The Company leases office space under non-cancellable
operating leases and leases cancellable with one month notice. The Company expenses the cancellable leases in the period incurred in accordance
with the practical expedient elected. During the nine months ended September 30, 2023, the Company amended two operating leases to extend
the lease term and entered into one new operating lease. As a result, the Company recognized additional operating lease liabilities and
corresponding operating right-of-use assets of $3,063,782.
For the three and nine months ended September 30,
2023, components of lease expense are summarized as follows:
Schedule
of Lease Expense
| |
Three Months Ended
September 30, 2023 | | |
Nine Months Ended
September 30, 2023 | |
Operating lease costs | |
$ | 244,941 | | |
$ | 529,089 | |
Short-term lease costs | |
| 38,110 | | |
| 192,261 | |
Total lease costs | |
$ | 283,051 | | |
$ | 721,350 | |
As of September 30, 2023, the maturities of the Company’s
lease liabilities are as follows:
Schedule
of Maturities on Company Lease Liabilities
| |
Year Ending December 31, | |
2023 (remainder) | |
$ | 233,826 | |
2024 | |
| 966,451 | |
2025 | |
| 987,252 | |
2026 | |
| 682,806 | |
Thereafter | |
| 542,512 | |
Total lease payments | |
| 3,412,847 | |
Less: imputed interest | |
| 367,938 | |
Present value of operating lease liabilities | |
| 3,044,909 | |
Less: current portion | |
| 794,516 | |
Long-term portion | |
$ | 2,250,393 | |
Other information related to operating leases was
as follows:
Schedule
of Other Information Related to Operating Lease
| |
Nine Months Ended September 30, 2023 | |
Cash paid for operating leases included in operating cash flows | |
$ | 680,580 | |
Remaining lease term of operating leases | |
| 4 years | |
Discount rate of operating leases | |
| 6.2 | % |
Litigation
Liabilities for loss contingencies arising from claims,
assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and
the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.
The Company is a defendant in two class action claims
and three derivative actions claiming that the Company promulgated false and misleading press releases to increase the price of our stock
to improperly benefit the officers and directors of the Company. The plaintiffs demand compensatory damages sustained as a result of the
Company’s alleged wrongdoing in an amount to be proven at trial. The Company is also a party to two commercial litigation lawsuits
in which plaintiffs are claiming they are owned certain remuneration based on alleged agreements with the Company. The Company believes
these lawsuits are without merit and intends to defend the cases vigorously. The Company is unable to estimate a range of loss, if any,
that could result were there to be an adverse final decision in these cases. As of the date of this report, the Company does not believe
it is probable that these cases will result in an unfavorable outcome; however, if an unfavorable outcome were to occur in these cases,
it is possible that the impact could be material to the Company’s results of operations in the period(s) in which any such outcome
becomes probable and estimable.
Note 11 – Share Repurchase Program
In March 2022, the Company’s Board of Directors
authorized a share repurchase program that would allow the Company to repurchase up to $30.0 million of CODX common stock. The repurchase
program does not obligate the Company to acquire any particular number of common shares, and the repurchase program may be suspended or
discontinued at any time at the Company’s discretion. The timing and amount of any share repurchases under the share repurchase
program will be determined by Co-Diagnostics’ management at its discretion based on ongoing assessments of the capital needs of
the business, the market price of the Company’s common stock, corporate and regulatory requirements, and general market conditions.
For accounting purposes, common stock repurchased
under the stock repurchase program is recorded based upon the transaction date of the applicable trade. Such repurchased shares are held
in treasury and are presented using the cost method. These shares are not retired and are considered issued but not outstanding. The following
table shows the changes in treasury stock (in shares) for the periods presented:
Schedule
of Treasury Stock
| |
Nine Months Ended | |
| |
September 30, 2023 | |
Balance, beginning of period | |
| 3,881,658 | |
Repurchases of common stock | |
| 826,862 | |
Balance, end of period | |
| 4,708,520 | |
Note 12 – Subsequent Events
In October 2023, the Company was awarded additional
grant funding of approximately $9.0 million from one of the granting entities from whom the Company had previously been awarded grant
funding during the three months ended September 30, 2023. The first $3.5 million of funding under this grant was received by the Company
in October 2023.
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking
statements” that involve risks and uncertainties. All statements other than statements of historical fact contained in this Quarterly
Report and the documents incorporated by reference herein, including statements regarding future events, our future financial performance,
business strategy, and plans and objectives of management for future operations, are forward-looking statements. We have attempted to
identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,”
“could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although
we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy.
These statements are only predictions and involve known and unknown risks, uncertainties and other factors and the documents incorporated
by reference herein, which may affect our or our industry’s actual results, levels of activity, performance or achievements expressed
or implied by these forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment.
New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors
on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those
contained in any forward-looking statements.
These forward-looking statements are subject to certain
risks and uncertainties that could cause our actual results to differ materially from those reflected in the forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk
Factors” in other documents we file with the SEC, including our Annual Report on form 10-K for the year ended December 31, 2022.
The following discussion should be read in conjunction with the Annual Report on Form 10-K for the fiscal year ended December 31, 2022,
filed with the SEC on March 16, 2023, and the audited financial statements and notes included therein.
As used in this Quarterly Report, the terms “we”,
“us”, “our”, and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated
subsidiaries (the “Company”), unless otherwise indicated.
Executive Overview
The following management’s discussion and analysis
of financial condition and results of operations describes the principal factors affecting the results of our operations, financial condition,
and changes in financial condition. This discussion should be read in conjunction with the accompanying unaudited financial statements
and notes thereto included elsewhere in this report. The information contained in this discussion is subject to a number of risks and
uncertainties. We urge you to review carefully the section of this report entitled “Cautionary Note Regarding Forward-Looking
Statements.”
Business Overview
Co-Diagnostics, Inc., a Utah corporation (the “Company”
or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis
of nucleic acid molecules (DNA or RNA), including robust and innovative molecular tools for detection of infectious diseases and agricultural
applications. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab
systems (which we refer to as the “MDx Device”). We are also developing a unique, groundbreaking portable PCR device and proprietary
test cups (the “Co-Dx PCR platform”) that have been designed to bring affordable, reliable polymerase chain reaction (“PCR”)
to patients in point-of-care and at-home settings. This platform is subject to U.S. Food and Drug Administration (“FDA”) review
and is not available for sale at the time of this filing. There is no guarantee that our Co-Dx PCR platform will receive the necessary
regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize
this platform.
Our diagnostics systems enable dependable, low-cost,
molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development
and administration of tests. CODX’s technical advance involves a novel, patented approach to PCR test design of primer and probe
structure (“Co-Primers™”) that eliminates one of the key vexing issues of PCR amplification: the exponential growth
of primer-dimer pairs (false positives and false negatives) which adversely interferes with identification of the target DNA/RNA.
We believe our proprietary molecular diagnostics technology
is paving the way for innovation in disease detection and life sciences research through our enhanced detection of genetic material. For
various reasons, including owning our own platform, we believe we will be able to accomplish this faster and more economically than some
competitors, allowing for significant margins while still positioning ourselves as a low-cost provider of molecular diagnostics and screening
services.
In addition, continued development has demonstrated
the unique properties of our Co-Primer technology that we believe makes it ideally suited for a variety of applications where specificity
is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide Polymorphism (“SNP”) detection
and enrichment for next generation sequencing.
Our scientists use the complex mathematics of DNA/RNA
PCR test design to engineer and optimize PCR tests and to automate algorithms that rapidly screen millions of possible options to pinpoint
the optimum design. Dr. Brent Satterfield, our founder, developed the intellectual property we use in our business, consisting of the
predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major advance
in PCR testing systems. Our flagship CoPrimers technology is covered by U.S. patents titled “Cooperative primers, probes, and applications
thereof” as well as by granted and pending foreign counterparts. We have other U.S. patents directed to our earlier work in primer
and assay designs. For more recent works, we have filed international and U.S. patent applications directed to “Methods and Compositions
for Next Generation Sequencing (NGS) Library Preparation,” “Allele-Specific Design of Cooperative Primers for Improved Nucleic
Acid Variant Genotyping,” “Methods and Compositions Related to Cooperative Primers and Reverse Transcription,” and “Systems,
Methods, and Apparatus for Automated Self-Contained Biological Analysis” which is the basis of our Co-Dx Platform. We intend to
continue building our patent portfolio as development continues and resources are available. Ownership of our proprietary platform permits
us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow the sale of diagnostic PCR
tests at a lower price than competitors, while enabling us to maintain profit margins.
Our proprietary test design process involves identifying
the optimal locations on the target genes for amplification and pair the locations with the optimized primer and probe structure to achieve
outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes,
procedures and testing. In other words, we use the data resulting from our tests to verify whether we succeeded in designing what we intended.
Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in
our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the
user needs.
We may either sell or lease the MDx Device to labs
and diagnostic centers, through sale or lease agreements, and sell the reagents that comprise our proprietary tests to those laboratories
and testing facilities.
Using our proprietary test design system and proprietary
reagents, we have designed and obtained regulatory approval in the United States, the European Community and/or in India. In the United
States, we are regulated by the FDA and our products must be approved, cleared, or authorized by the FDA before we are allowed to sell
our tests in the United States as in vitro diagnostics. The FDA granted us an EUA to manufacture and sell our Logix Smart COVID-19 test
to CLIA labs in the United States. We are ISO 13485:2016 certified, relating to the design and manufacture of our medical device products.
Being ISO certified greatly facilitates our applications for CE-Marking, which allows us to sell any CE Marked test in most countries
in Europe, South America and Asia, depending on the country and following that country’s registration process. We currently have
CE Markings issued for our Logix Smart COVID-19 test, tuberculosis test, our Zika virus test, a triplex test that tests for Zika, dengue,
and chikungunya simultaneously, a triplex “ABC” test that identifies and distinguishes between Flu A, Flu B and Covid-19,
our SARS-CoV-2 2-gene multiplex test, and our DS (Direct Saliva, extraction-free) COVID-19 test. In addition, our Logix Smart COVID-19
has received the required license to manufacture and sell in India from India’s CDSCO, and The National Epidemiology Institute in
Mexico evaluated our Logix Smart COVID-19 and ABC tests and approved them for sale in Mexico. We have also received approval to sell our
Logix Smart COVID-19 test in Australia. We are in the process of registering for sale our Logix Smart COVID-19 and other tests in a number
of major countries around the world.
In addition to testing for infectious disease, the
technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several
significant applications. We, in conjunction with our customers, are active in designing and licensing tests that identify genetic traits
in plant and animal genomes. We also have three multiplexed tests developed to test mosquitos for the identification of diseases carried
by the mosquitos to enable municipalities to concentrate their efforts in managing mosquito populations on the specific areas known to
be breeding the mosquitos that carry deadly viruses.
RESULTS OF OPERATIONS
The Three Months Ended September 30, 2023 Compared
to the Three Months ended September 30, 2022
Revenues
For the three months ended September 30, 2023, we
generated revenues of $2,457,098, compared to revenues of $5,094,456 for the three months ended September 30, 2022. Grant funding awarded
to the Company accounted for $2,320,565 of revenue for the three months ended September 30, 2023. The decrease in total revenue of $2,637,358
was primarily due to lower sales of our Logix Smart COVID-19 test developed in response to the COVID-19 pandemic.
Cost of Revenues
We recorded cost of revenues of $255,772 for the three
months ended September 30, 2023, compared to $767,936 for the three months ended September 30, 2022. The decrease in revenues combined
with a larger percentage of fixed product production costs, as well as costs related to expired inventory, resulted in a lower cost of
revenues and lower gross margin percentage, after adjusting for the effect of the grant revenue awarded.
Expenses
We incurred total operating expenses of $11,137,277
for the three months ended September 30, 2023, compared to total operating expenses of $10,862,135 for the three months ended September
30, 2022. The increase in operating expenses was primarily due to increased personnel expenses, including stock-compensation expense,
and additional investment in research and development. These increases were partially offset by decreased expenses experienced in conjunction
with our decrease in revenues, such as third-party sales commissions, reflected in sales and marketing and variable compensation.
Our sales and marketing expenses for the three months
ended September 30, 2023 were $1,904,395, compared to $1,889,907 for the three months ended September 30, 2022. The increase was primarily
a result of increased stock-based compensation expense and professional services expense, partially offset by decreased variable compensation,
such as bonuses and commissions, decreased third-party sales commissions, and tradeshow and travel expenses.
General and administrative expenses decreased from
$3,622,273 for the three months ended September 30, 2022 to $3,147,753 for the three months ended September 30, 2023. The decrease in
general and administrative expenses was primarily due to decreased bad debt expense, insurance expense, variable compensation expense,
and professional services expenses, partially offset by increased stock-based compensation expense.
Our research and development expenses increased from
$5,037,461 for the three months ended September 30, 2022 to $5,788,789 for the three months ended September 30, 2023. The primary increase
in expenses was a result of increases in personnel related expenses and increases in expenses related to development and clinical trials
of the Co-Dx PCR platform.
Other Income (expense)
For the three months ended September 30, 2023 we had
total other income of $840,176, compared to total other income of $3,059,915 for the three months ended September 30, 2022. The primary
components of other income include a change in the fair value of contingent consideration liabilities recorded in conjunction with the
acquisitions of IdMo and ACI and interest income and realized gains from investments in marketable securities.
Net Income (loss)
We realized a net loss for the three months ended
September 30, 2023 of $5,982,194, compared to a net loss for the three months ended September 30, 2022 of $1,361,062. The larger net loss
was primarily the result of a decrease in revenues, combined with an increase of operating expenses, partially offset by changes in the
fair value of acquisition contingencies and income related to investments in marketable securities. Additionally, we recorded an income
tax benefit of $2,113,581 for the three months ended September 30, 2023, compared to an income tax benefit of $2,114,638 for the three
months ended September 30, 2022.
The Nine Months Ended September 30, 2023 Compared
to the Nine Months ended September 30, 2022
Revenues
For the nine months ended September 30, 2023, we generated
revenues of $3,256,861, compared to revenues of $32,816,726 for the nine months ended September 30, 2022. The decrease in revenue of $29,559,865
was primarily due to lower sales of our Logix Smart COVID-19 test developed in response to the COVID-19 pandemic.
Cost of Revenues
We recorded cost of revenues of $1,217,108 for the
nine months ended September 30, 2023, compared to $4,965,319 for the nine months ended September 30, 2022. The decrease in revenues combined
with a larger percentage of fixed product production costs, as well as costs related to expired inventory, resulted in a lower cost of
revenues and lower gross margin percentage.
Expenses
We incurred total operating expenses of $32,920,793
for the nine months ended September 30, 2023, compared to total operating expenses of $28,709,900 for the nine months ended September
30, 2022. The increase in operating expenses was primarily due to increased personnel expenses, including stock-compensation expense,
and additional investment in research and development. These increases were partially offset by decreased expenses experienced in conjunction
with our decrease in revenues, such as third-party sales commissions reflected in sales and marketing, and variable compensation.
Our sales and marketing expenses for the nine months
ended September 30, 2023 were $5,343,692, compared to $6,014,280 for the nine months ended September 30, 2022. The decrease was primarily
a result of decreased variable compensation, such as bonuses and commissions, and decreased third-party sales commissions, partially offset
by increased stock-based compensation expense, tradeshow and travel expenses, and professional services expense.
General and administrative expenses increased from
$9,012,888 for the nine months ended September 30, 2022 to $9,875,613 for the nine months ended September 30, 2023. The increase in general
and administrative expenses was primarily due to increased professional, legal, and advisory fees expenses, increased stock-based compensation
expense, and increased bad debt expense, partially offset by decreased variable compensation expense and decreased insurance expense.
Our research and development expenses increased from
$12,698,632 for the nine months ended September 30, 2022 to $16,783,892 for the nine months ended September 30, 2023. The primary increase
in expenses was a result of increases in personnel related expenses, increases in expenses related to development and clinical trials
of the Co-Dx PCR platform, and increased stock-based compensation expense.
Other Income (expense)
For the nine months ended September 30, 2023 we had
total other income of $3,612,918, compared to total other income of $7,055,666 for the nine months ended September 30, 2022. The primary
components of other income include a change in the fair value of contingent consideration liabilities recorded in conjunction with the
acquisitions of IdMo and ACI and interest income and realized gains from investments in marketable securities.
Net Income (loss)
We realized a net loss for the nine months ended September
30, 2023 of $20,656,410, compared with net income for the nine months ended September 30, 2022 of $7,667,231. The shift from net income
to net loss was primarily the result of a decrease in revenues, combined with an increase of operating expenses, partially offset by changes
in the fair value of acquisition contingencies and income related to investments in marketable securities. Additionally, we recorded an
income tax benefit of $6,611,712 for the nine months ended September 30, 2023, compared to an income tax benefit of $1,470,058 for the
nine months ended September 30, 2022.
Liquidity and Capital Resources
At September 30, 2023, we had cash and cash equivalents
of $10,239,898. Additionally, we had $53,188,999 of marketable investment securities that could readily be converted into cash if needed.
Additionally, our total current assets of September 30, 2023, were $71,310,781 compared to total current liabilities of $5,097,740.
Net cash used in operating activities during the nine
months ended September 30, 2023 was $17,303,239, compared to cash provided by operating activities of $10,578,544 for the nine months
ended September 30, 2022. The decrease in cash from operating activities was primarily due to decreased revenues and the impact of non-cash
items.
Net cash provided by investing activities during the
nine months ended September 30, 2023 was $5,773,590, primarily from maturities of marketable investment securities, compared to cash used
in investing activities of $4,861,292 during the nine months ended September 30, 2022.
Net cash used in financing activities was $1,204,256
for the nine months ended September 30, 2023, compared to net cash used in financing activities of $12,816,503 for the same period in
the prior year. This decrease is due to the repurchase of fewer outstanding common shares during the first nine months of the year, compared
to the same period of the prior year.
Since commencing sales of our Logix Smart COVID-19
test in March 2020, we have used cash generated from those sales to fund the procurement and production of inventory and to pay our operating
expenses. We have increased our work force primarily in the area of research and development to develop the Co-Dx PCR platform and complete
development of additional tests to enable us to use our distributor network to sell other products throughout the world and become profitable
in the future. In March 2022 our board of directors authorized the repurchase of up to $30.0 million of the company’s outstanding
common stock. We have no obligation to repurchase any shares under the repurchase program and may suspend or discontinue it at any time
without prior notice. As of September 30, 2023 we have repurchased 4,708,520 outstanding common shares under the repurchase program for
a total of $15.4 million.
Additionally, in March 2023, we filed a shelf registration
statement on Form S-3 (the “Shelf Registration Statement”) with the SEC registering the sale, from time-to-time of up to $150
million of our securities. In connection with the Shelf Registration Statement, we filed an equity distribution agreement prospectus covering
the offering, issuance and sale of up to a maximum of $50 million shares of our common stock that may be issued and sold under an equity
distribution agreement with Piper Sandler & Co. We are under no obligation to sell any securities under the Shelf Registration Statement
or the equity distribution agreement with Piper Sandler & Co. We have not sold any shares under the equity distribution agreement
with Piper Sandler & Co.
We believe that our existing capital resources and
the cash generated from future sales will be sufficient to meet our projected operating requirements for the next 12 months. However,
our available capital resources may be consumed more rapidly than currently expected and we may need or want to raise additional financing
for strategic opportunities.
If needed, we expect additional investment capital
to come from (i) additional issuances of our common stock with existing and new investors or (ii) the private placement of other securities
with investors similar to those that have provided funding in the past. We may not be able to secure such financing in a timely manner
or on favorable terms, if at all.
The foregoing estimates, expectations and forward-looking
statements are subject to change as we make strategic operating decisions from time to time and as our revenue and expenses fluctuate
from period to period.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosures
about Market Risk
Not required under Regulation S-K for “smaller
reporting companies.”
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,”
as defined in Rules 13a-15I and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the
Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial
officers, as appropriate to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief
Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September
30, 2023. Based on the evaluation of our disclosure controls and procedures as of September 30, 2023, our Chief Executive Officer and
Chief Financial Officer concluded that, as of such date, our disclosure controls were effective.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control
over financial reporting during the three months ended September 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 Proceedings
Co-Diagnostics,
Inc. v. Hukui Technology, Inc., et al. (Third Judicial District Court, Salt Lake County, State of Utah, Civil No. 210902131, filed on
April 21, 2021).
The
Company previously disclosed that it had filed a complaint against Defendants Hukui Technology, Inc., Hukui Tech, Inc., and Hukui Bio
Co., Ltd (collectively, “Hukui”) seeking a declaratory judgment that the Company is not obligated to any of them in any amount.
On August 24, 2021, Hukui filed their Answer and Counterclaim seeking damages on a number of theories, including breach of contract for
letter agreements, breach of oral agreement, promissory estoppel, unjust enrichment, and interference with economic relations. On June
1, 2023 the Company filed a Motion for Summary Judgment asking the court for summary judgment on its sole claim for declaratory relief
and for summary judgment with respect to all Hukui counterclaims. On November 7, 2023, the Court issued it decision and granted the
Company summary judgment on its sole claim for declaratory relief and on all Hukui counterclaims.
There have been no other developments to the legal
proceedings previously disclosed under Part I. Item 3 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and
under Part II. Item 1. of our Quarterly Reports on form 10-Q previously filed with the SEC.
Item 1A. Risk Factors.
Not required under Regulation S-K for “smaller
reporting companies.”
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds
None.
Dividends
We have never declared or paid any cash dividends
on our capital stock. The payment of dividends on our common stock in the future will depend on our earnings, capital requirements, operating
and financial condition and such other factors as our Board of Directors may consider appropriate. We currently expect to use all available
funds to finance the future development and expansion of our business and do not anticipate paying dividends on our common stock in the
foreseeable future.
Pursuant to Section 16-10a-640 of the Utah Revised
Business Corporation Act, no distribution may be made if, after giving it effect:
|
(a) |
the corporation would not be able to pay its debts as they become due in the usual course of business; or |
|
|
|
|
(b) |
the corporation’s total assets would be less than the sum of its total liabilities plus, unless the articles of incorporation permit otherwise, the amount that would be needed, if the corporation were to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of shareholders whose preferential rights are superior to those receiving the distribution. |
Share Repurchase Program
Period | |
(a) Total number of shares purchased (1) | | |
(b) Average price paid per share (1) | | |
(c ) Total number of shares purchased as part of publicly announced plans or programs (1) | | |
(d) Maximum number (or approximate dollar value) of shares that may yet be purchased under the plans or programs (1) | |
07/01/23 – 07/31/23 | |
| - | | |
$ | - | | |
| - | | |
$ | 14,750,204 | |
08/01/23 – 08/31/23 | |
| - | | |
$ | - | | |
| - | | |
$ | 14,750,204 | |
09/01/23 – 09/30/23 | |
| 149,041 | | |
$ | 1.12 | | |
| 149,041 | | |
$ | 14,583,878 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
| 149,041 | | |
$ | 1.12 | | |
| 149,041 | | |
$ | 14,583,878 | |
|
(1) |
In March 2022 the company announced that its board of directors authorized the repurchase of up to $30.0 million of the company’s outstanding common stock. The extent to which the company repurchases its shares, and the timing of such repurchases, will depend upon a variety of factors, including trading volume, market conditions, legal requirements, business conditions and other factors. The repurchase program may be discontinued at any time, and the program does not obligate the company to acquire any specific number of shares of its common stock. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
Exhibit Index
(a) Exhibits
* Filed herewith.
# Management Contract or Compensatory Plan
or Arrangement
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.
|
CO-DIAGNOSTICS, INC. |
|
|
|
Date: November 9, 2023 |
By: |
/s/ Dwight H. Egan |
|
Name: |
Dwight H. Egan |
|
Title: |
Chief Executive Officer, President and Principal Executive Officer |
|
|
|
Date: November 9, 2023 |
By: |
/s/ Brian Brown |
|
Name: |
Brian Brown |
|
Title: |
Chief Financial Officer and Principal Financial and Accounting Officer |
Exhibit
10.1
COMMERCIAL
LEASE AGREEMENT
This
Commercial Lease Agreement (hereinafter, the “Lease”) is a legal and binding contract. Before signing, read the entire
document, including the general printed provisions and any attachments. If you have any questions, consult your attorney before signing.
This
Lease is made and entered into as of the 18th day of September, 2023, by and between the following parties:
|
Landlord(s):
|
Ge
Estate, LLC (“Landlord”) |
|
Address
for Notices: |
1405
Siesta Drive Sandy, Utah 84093 |
|
|
|
|
Tenant(s):
|
Co-Diagnostics,
Inc. |
|
Address
for Notices: |
2401 South Foothill Drive |
|
|
Unit
D |
|
|
Salt
Lake City, Utah 84109 |
In
consideration of the rents, covenants and agreements hereinafter set forth. Landlord and Tenant mutually agree as follows:
1.
Premises. Landlord hereby leases to Tenant and Tenant hereby leases from Landlord the following property: 3215 S 300 W, Salt Lake
City, Utah (the “Premises”) comprising the entire building of approximately 3,200 square footage and the entire parcel
including all parking and adjacent lot areas. The Premises consists of approximately 3,200 square feet of space and this estimate of
square footage shall be used for all calculations under this Lease. In addition, for the term of this Lease, Landlord grants Tenant a
non-exclusive easement for ingress and egress by vehicular and pedestrian traffic, including a right of use and access, through the gate
located on the East side of the adjacent property that provides access to the 3222 South Washington Building that Landlord owns and Tenant
leases from Landlord. Landlord also grants Tenant a non-exclusive easement for ingress and egress by vehicular and pedestrian traffic
to access said gate through the property of 3211 South 300 West to the gate. Gate and easement are identified as marked in Exhibit A.
2.
Term of Lease. This Lease shall begin October 1, 2023 and shall be for an initial term of thirty-nine (39) months (“Initial
Term”) beginning October 1, 2023 and ending December 31st 2026.
3.
Extension of Lease Term. Tenant may extend the lease for 1 additional 2-year term by giving notice to Landlord no later than May
1st, 2024. If Tenant extends the lease the rent shall increase by 3% for each extension lease year over the previous year.
4.
Delivery of Possession. Tenant shall be entitled to possession of the Premises on October 1, 2023, provided that Tenant has (a)
executed this Lease; and (b) paid to Landlord the sum of $_5,000.00, consisting of Rent for October, 2023, Landlord shall remove existing
landlord owned equipment and personal effects prior to possession. Tenant acknowledges that it has examined the Premises and accepts
the same in as-is condition and as being in the condition called for by this Lease.
5.
Monthly Rent. Tenant shall pay “Monthly Rent” to Landlord, in advance and without prior demand, invoice or
notice on or before the first day of each calendar month during the Term of this Lease, as follows:
Lease Year 1 Months 1-12 | |
$ | 2,500 | |
Lease Year 2 | |
$ | 2,575 | |
Lease Year 3 | |
$ | 2,652 | |
Payment
shall be made by direct bank deposit, and Landlord shall provide Tenant with information needed to set up the direct bank deposit.
6.
Triple Net (NNN) Expenses. This lease is a gross lease. Landlord shall be responsible for all Property Tax, Building Insurance
and Utilities paid directly by the Landlord.
7.
Late Charges. If Tenant fails to pay any amounts or charges of any character which are payable under this Lease, Landlord, at
Landlord’s election, may assess and collect a late fee charge equal to 10% of each payment of rent not received within five business
days from the date such rent payment is due. In addition, Landlord shall be eligible to charge interest at a rate of 18% per annum on
any payments later than 30 days.
8.
Security Deposit. Upon execution of this Lease, Tenant shall deposit with Landlord a deposit in the amount of Two-Thousand Five-Hundred
Dollars ($2,500.00) as security for the performance by Tenant of all of the terms, covenants, and conditions required to be performed
by it hereunder. Such sum shall be returned to Tenant within 30 days after the expiration of the Term and delivery of possession of the
Premises to Landlord if, at such time, Tenant has performed all such terms, covenants, and conditions of this Lease. If an event of default
(as defined in Section 19) by Tenant with respect to any of its obligations under this Lease shall occur, including but not limited to,
the payment of Rent or utilities, Landlord may use, apply, or retain all or any part of the security deposit for the payment of any unpaid
Rent or utilities, or any amounts Landlord may be required to expend by reason of the occurrence of the event of default by Tenant, including
any damages or deficiency in the reletting of the Premises, regardless of whether the accrual of such damages or deficiency occurs before
or after an eviction. If all or a portion of the security deposit is so used or applied, Tenant shall, upon ten (10) days’ written
demand, deposit immediately available funds with Landlord in an amount sufficient to restore the security deposit to its original amount.
9.
Utilities. Unless stated to the contrary elsewhere in this Lease, Tenant shall directly pay for all utilities used by Tenant on
the Premises (i.e., telephone, internet, electricity, etc.).
10.
Landlord’s Responsibility for Maintenance and Repairs. Landlord shall, during the term of this Lease, keep in good order
condition, and repair, the exterior walls, foundations and roof unless such repairs are caused by gross negligence of the Tenant. Landlord
shall incur no expense nor have any obligation of any kind whatsoever in connection with maintenance of the Premises other than specifically
set forth in this paragraph, and Tenant expressly waives the benefits of any statute now or hereafter in effect which would otherwise
afford Tenant the right to make repairs at Landlord expense or to terminate this Lease because of Landlord’s failure to keep the
Premises in good order, condition, and repair.
11.
Tenant’s Responsibility for Maintenance and Repairs. Tenant shall, during the term of this Lease, keep in good order condition,
and repair, any part of the Premises not specifically included within Landlord’s responsibility above. Tenant’s responsibility
shall include, for example and not limited to: (a) the interior of the Premises and every part thereof, structural or nonstructural;
(b) repair of HVAC system that require repair and replacement; (c) interior plumbing and electrical; (d) landscaping (e) all other items
not specifically listed as Landlord Responsibility in item 12 above.
12.
Alterations and Improvements. Tenant may make any alterations, improvements additions, or utility installations (including power
panels) in or about the Premises required to operate the Tenant’s business. Tenant shall bear all costs and expenses associated
with any Alterations or Improvements to the premise that they perform.
13.
Initial Alterations and Improvements. Landlord agrees to perform the following Repairs to the premise:
a.
NONE
Tenant
shall be responsible for all other Alterations and Improvements they deem necessary for the operation of the business.
14.
Signage. Tenant shall be allowed to install city permitted signage, any sign authorized by Landlord shall be removed and the sign
space restored to its original condition upon termination of the Lease.
15.
Tenant’s Insurance. Tenant, at its own expense, shall provide and keep in force liability insurance in the commercial general
liability form (or reasonable equivalent thereto) covering the Premises and Tenant’s use thereof against claims for personal injury
or death, property damage and product liability occurring upon, in or about the Premises, such insurance to be written on an occurrence
basis (not a claims made basis), with combined single limit coverage of not less than $1,000,000.00 and with a general aggregate limit
of not less than $2,000,000.00 for each policy year. Tenant shall furnish Landlord with a certificate of such policy and whenever required
shall satisfy Landlord that such policy is in full force and effect. Such policy shall name Landlord as an additional insured and shall
be primary and non-contributing with any insurance carried by Landlord. The policy shall further provide that it shall not be cancelled
or altered without 30 days prior written notice to Landlord. Tenant shall furnish evidence of renewal of such insurance policies within
10 days before expiration of any such policy.
16.
Permitted and Prohibited Use. Tenant shall use the Property as office, production and warehouse space for its existing biotechnology
business and such related uses as required for the Tenant’s operations.
17.
Assignment and Sublease. Tenant may, with Landlord’s written consent, assign, mortgage or hypothecate this Lease or any
interest in this Lease or permit the use of the Premises by any person or persons other than Tenant, or sublet the Premises, or any part
of the Premises. Assignment of the Lease to another party shall not relieve the Tenant of any of its obligations under this Lease.
18.
Quiet Enjoyment. Landlord hereby covenants to Tenant that, subject to Tenant’s compliance with the terms and provisions
of this Lease, Tenant shall peaceably and quietly hold and enjoy the full possession and use of the Premises during the term of this
Lease.
19.
Default by Tenant. Upon the occurrence of any of the following events, Tenant shall be in default of its obligations under this
Lease (a) Tenant fails to pay any sum due hereunder on or before the date the same is due and such failure continues for five (5) calendar
days after said due date; (b) Tenant fails to perform any other material term, condition or covenant to be performed by it pursuant to
this Lease within 10 days after written notice of such default has been given to Tenant by Landlord; (c) Tenant becomes bankrupt or insolvent
or files a petition in bankruptcy court as a debtor (which, in the case of an involuntary proceeding, is not permanently discharged,
dismissed, stayed, or vacated, as the case may be, within sixty (60) days of commencement); (d) Tenant abandons or vacates the Premises;
or (e) Tenant assigns or subleases the Premises or encumbers its interest in this Lease without written consent of Landlord (collectively
“Events of Default”). Upon the occurrence of any Event of Default, Landlord, in addition to all other rights and remedies
provided by law or in equity or otherwise provided in this Lease, may, without further notice or demand of any kind to Tenant or any
other person, retake the Premises, accelerate all payments due under this Lease and collect by suit or otherwise, all such amounts due
and terminate this Lease. Tenant’s payment obligations shall survive any such termination.
20.
Chronic Default by Tenant. In order to discourage chronic non-compliance with any provision of this Lease, Tenant shall be conclusively
deemed to have incurably defaulted under this Lease at such time as Tenant has triggered an Event of Default for the third time during
any twelve-month period, regardless of whether any such Event of Default is or has been cured by Tenant.
21.
Default by Landlord. Landlord will not be in default under this Lease unless Landlord fails to perform an obligation required
of it within 30 days after written Notice by Tenant to Landlord specifying the respects in which Landlord has failed to perform such
obligation; provided, however, that if the nature of Landlord’s obligation is such that more than 30 days are reasonably required
for performance or cure, Landlord will not be in default if Landlord commences performance within such thirty (30) day period and thereafter
diligently prosecutes the same to completion. Tenant’s rights in case of Landlord’s default are limited to reimbursement
of its actual damages directly incurred as a result of such default. In no event will Tenant have the right to terminate this Lease or
to withhold the payment of Rent or other charges provided for herein as a result of Landlord’s default.
22.
Independent Obligations. Notwithstanding anything to the contrary in this Lease, Tenant’s obligation to pay is independent
from any of Landlord’s obligations under this Lease. Tenant will pay amounts due hereunder without any deduction, diminution, abatement,
counterclaim or offset for any reason whatsoever. Acceptance of a lower amount than due shall not be deemed an accord or satisfaction,
and Landlord reserves all rights to receive full payment of the amount owed.
23.
Construction of Lease. This Lease shall be construed without regard to the identity of the person who drafted it or the party
who caused it to be drafted. It shall be deemed their joint work product, and each and every provision of this Lease shall be construed
as though all parties hereto participated equally in the drafting hereof. As a result of the foregoing, any rule of construction that
a document is to be construed against the drafting party shall not be applicable.
24.
Attorney’s Fees to Prevailing Party. In the event either Landlord or Tenant commences litigation to enforce any of the terms
and conditions of this Lease, the unsuccessful party to the litigation will pay all costs and expenses, including reasonable attorney’s
fees and actual costs of litigation, incurred by the successful party. In the case where Landlord recovers some, but not all, of any
claimed damages from Tenant, Landlord shall still be deemed the successful party for the purposes of this paragraph.
25.
Complete Agreement. This Lease contains all of the agreements and conditions made between the parties to the Lease related to
the Premises in any way. There are no oral agreements that supplement the provisions of this Lease. All oral agreements not incorporated
herein are cancelled and superseded by this Lease. This Lease may not be modified orally or in any other manner than by an agreement
in writing signed by all the parties to this Lease.
26.
Conflict of Laws. This Lease shall be governed by and construed solely pursuant to the laws of the State of Utah, without giving
effect to choice of law principles thereunder.
27.
Force Majeure. If either Landlord or Tenant is delayed, hindered in or prevented from the performance of any act required under
this Lease by reason of strikes, lock-outs, labor troubles, inability to procure standard materials, failure of power, restrictive governmental
laws, regulations or orders or governmental action or inaction (including failure, refusal or delay in issuing permits, approvals and/or
authorizations which is not the result of the action or inaction of the party claiming such delay), riots, civil unrest or insurrection,
war, fire, earthquake, flood or other natural disaster, unusual and unforeseeable delay which results from an interruption of any public
utilities (e.g., electricity, gas, water, telephone), pandemic, or other unusual and unforeseeable delay not within the reasonable control
of the party delayed in performing work or doing acts required under the provisions of this Lease, then performance of such act will
be excused for the period of the delay and the period for the performance of any such act will be extended for a period equivalent to
the period of such delay.
Accepted
and agreed:
Tenant:
Co-Diagnostics, Inc. |
|
Landlord: |
|
|
|
By: |
|
|
By: |
|
|
Brian
Brown, CFO |
|
|
Jim
Gurr |
|
for
Tenant |
|
|
Agent
for Landlord |
|
|
|
|
|
Date: |
|
|
Date: |
|
Exhibit
A
Easement
and Gate location
Exhibit
31.1
CERTIFICATION
OF THE CHIEF EXECUTIVE OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
AND
RULE 13a-14 OF THE EXCHANGE ACT OF 1934
I,
Dwight H. Egan, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Co-Diagnostics, 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: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepting accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
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): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
November 9, 2023 |
By: |
/s/
Dwight H. Egan |
|
|
Dwight
H. Egan |
|
|
Chief
Executive Officer, President and Principal Executive Officer |
EXHIBIT
31.2
CERTIFICATION
OF THE CHIEF FINANCIAL OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
AND
RULE 13a-14 OF THE EXCHANGE ACT OF 1934
I,
Brian Brown, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Co-Diagnostics, 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: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepting accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
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): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
November 9, 2023 |
By: |
/s/
Brian Brown |
|
|
Brian
Brown |
|
|
Chief
Financial Officer and Principal Financial and Accounting Officer |
EXHIBIT
32.1
CERTIFICATION
OF THE CHIEF EXECUTIVE OFFICER
PURSUANT
TO 18 U.S. C. SECTION 1350
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Co-Diagnostics, Inc. (the “Company”) on Form 10-Q for the period ended September
30, 2023, as filed with the Securities and Exchange Commission on the date hereof, I, Dwight H. Egan, Chief Executive Officer of the
Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that,
to my knowledge:
|
(1) |
The
Form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The
information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
November 9, 2023 |
By:
|
/s/
Dwight H. Egan |
|
|
Dwight
H. Egan |
|
|
Chief
Executive Officer, President and Principal Executive Officer |
EXHIBIT
32.2
CERTIFICATION
OF THE CHIEF FINANCIAL OFFICER
PURSUANT
TO 18 U.S. C. SECTION 1350
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Co-Diagnostics, Inc. (the “Company”) on Form 10-Q for the period ended September
30, 2023, as filed with the Securities and Exchange Commission on the date hereof, I, Brian Brown, Chief Financial Officer of the Company,
hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my
knowledge:
|
(1) |
The
Form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The
information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
November 9, 2023 |
By: |
/s/
Brian Brown |
|
|
Brian
Brown |
|
|
Chief
Financial Officer and Principal Financial and Accounting Officer |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 08, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-38148
|
|
Entity Registrant Name |
CO-DIAGNOSTICS,
INC.
|
|
Entity Central Index Key |
0001692415
|
|
Entity Tax Identification Number |
46-2609396
|
|
Entity Incorporation, State or Country Code |
UT
|
|
Entity Address, Address Line One |
2401
S. Foothill Drive
|
|
Entity Address, Address Line Two |
Suite D
|
|
Entity Address, City or Town |
Salt Lake City
|
|
Entity Address, State or Province |
UT
|
|
Entity Address, Postal Zip Code |
84109
|
|
City Area Code |
(801)
|
|
Local Phone Number |
438-1036
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
CODX
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
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false
|
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v3.23.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash and cash equivalents |
$ 10,239,898
|
$ 22,973,803
|
Marketable investment securities |
53,188,999
|
58,289,066
|
Accounts receivable, net |
806,704
|
3,453,723
|
Inventory, net |
4,520,430
|
5,310,473
|
Income taxes receivable |
1,245,854
|
1,870,419
|
Prepaid expenses and other current assets |
1,290,146
|
761,187
|
Note receivable |
18,750
|
75,000
|
Total current assets |
71,310,781
|
92,733,671
|
Property and equipment, net |
2,808,339
|
2,539,483
|
Deferred tax asset |
4,272,002
|
|
Operating lease right-of-use asset |
3,032,337
|
372,115
|
Intangible assets, net |
26,479,333
|
26,768,333
|
Investment in joint venture |
778,943
|
672,679
|
Total assets |
108,681,735
|
123,086,281
|
Current liabilities |
|
|
Accounts payable |
1,416,435
|
952,296
|
Accrued expenses, current |
1,826,639
|
934,447
|
Operating lease liability, current |
794,516
|
297,209
|
Contingent consideration liabilities, current |
710,651
|
1,689,471
|
Deferred revenue |
349,499
|
|
Total current liabilities |
5,097,740
|
3,873,423
|
Long-term liabilities |
|
|
Income taxes payable |
1,359,725
|
1,181,284
|
Deferred tax liability |
|
2,417,987
|
Operating lease liability |
2,250,393
|
50,708
|
Contingent consideration liabilities |
484,332
|
1,042,885
|
Total long-term liabilities |
4,094,450
|
4,692,864
|
Total liabilities |
9,192,190
|
8,566,287
|
Stockholders’ equity |
|
|
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized; 35,367,100 shares issued and 30,658,580 shares outstanding as of September 30, 2023 and 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022 |
35,367
|
34,754
|
Treasury stock, at cost; 4,708,520 and 3,881,658 shares held as of September 30, 2023 and December 31, 2022, respectively |
(15,416,122)
|
(14,211,866)
|
Additional paid-in capital |
94,983,030
|
88,472,935
|
Accumulated other comprehensive income |
612,649
|
293,140
|
Accumulated earnings |
19,274,621
|
39,931,031
|
Total stockholders’ equity |
99,489,545
|
114,519,994
|
Total liabilities and stockholders’ equity |
$ 108,681,735
|
$ 123,086,281
|
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v3.23.3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Convertible preferred stock, par value |
$ 0.001
|
$ 0.001
|
Convertible preferred stock , shares authorized |
5,000,000
|
5,000,000
|
Convertible preferred stock, shares issued |
0
|
0
|
Convertible preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
35,367,100
|
34,754,265
|
Common stock, shares outstanding |
30,658,580
|
30,872,607
|
Treasury stock, shares |
4,708,520
|
3,881,658
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Total revenue |
$ 2,457,098
|
$ 5,094,456
|
$ 3,256,861
|
$ 32,816,726
|
Cost of revenue |
255,772
|
767,936
|
1,217,108
|
4,965,319
|
Gross profit |
2,201,326
|
4,326,520
|
2,039,753
|
27,851,407
|
Operating expenses |
|
|
|
|
Sales and marketing |
1,904,395
|
1,889,907
|
5,343,692
|
6,014,280
|
General and administrative |
3,147,753
|
3,622,273
|
9,875,613
|
9,012,888
|
Research and development |
5,788,789
|
5,037,461
|
16,783,892
|
12,698,632
|
Depreciation and amortization |
296,340
|
312,494
|
917,596
|
984,100
|
Total operating expenses |
11,137,277
|
10,862,135
|
32,920,793
|
28,709,900
|
(Loss) from operations |
(8,935,951)
|
(6,535,615)
|
(30,881,040)
|
(858,493)
|
Other income, net |
|
|
|
|
Interest income |
322,877
|
298,184
|
717,141
|
371,248
|
Realized gain on investments |
425,446
|
|
1,254,718
|
|
Gain (loss) on disposition of assets |
(2,578)
|
4,044
|
(2,578)
|
(138,117)
|
Gain on remeasurement of acquisition contingencies |
140,296
|
2,886,734
|
1,537,373
|
7,079,446
|
Gain (loss) on equity method investment in joint venture |
(45,865)
|
(129,047)
|
106,264
|
(256,911)
|
Total other income, net |
840,176
|
3,059,915
|
3,612,918
|
7,055,666
|
Income (loss) before income taxes |
(8,095,775)
|
(3,475,700)
|
(27,268,122)
|
6,197,173
|
Income tax (benefit) |
(2,113,581)
|
(2,114,638)
|
(6,611,712)
|
(1,470,058)
|
Net income (loss) |
(5,982,194)
|
(1,361,062)
|
(20,656,410)
|
7,667,231
|
Other comprehensive income (loss) |
|
|
|
|
Change in net unrealized gains on marketable securities, net of tax |
33,522
|
|
319,509
|
|
Total other comprehensive income |
33,522
|
|
319,509
|
|
Comprehensive income (loss) |
$ (5,948,672)
|
$ (1,361,062)
|
$ (20,336,901)
|
$ 7,667,231
|
Earnings (loss) per common share: |
|
|
|
|
Basic |
$ (0.20)
|
$ (0.04)
|
$ (0.70)
|
$ 0.24
|
Diluted |
$ (0.20)
|
$ (0.04)
|
$ (0.70)
|
$ 0.23
|
Weighted average shares outstanding: |
|
|
|
|
Basic |
29,361,300
|
31,321,368
|
29,306,572
|
32,109,213
|
Diluted |
29,361,300
|
31,321,368
|
29,306,572
|
33,002,539
|
Product Revenue [Member] |
|
|
|
|
Total revenue |
$ 136,533
|
$ 5,094,456
|
$ 936,296
|
$ 32,816,726
|
Grant Revenue [Member] |
|
|
|
|
Total revenue |
$ 2,320,565
|
|
$ 2,320,565
|
|
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities |
|
|
Net (loss) income |
$ (20,656,410)
|
$ 7,667,231
|
Adjustments to reconcile net income to cash (used in) provided by operating activities: |
|
|
Depreciation and amortization |
917,596
|
984,100
|
Stock-based compensation expense |
6,510,708
|
5,138,815
|
Change in fair value of acquisition contingencies |
(1,537,373)
|
(7,079,446)
|
Non-cash lease expense |
36,770
|
17,193
|
Realized gain on investments |
(1,254,718)
|
|
(Gain) loss from equity method investment |
(106,264)
|
256,911
|
Loss on disposition of assets |
2,578
|
138,117
|
Deferred income taxes |
(6,689,989)
|
(3,431,286)
|
Bad debt expense |
326,647
|
338,057
|
Changes in assets and liabilities: |
|
|
Accounts receivable |
2,320,372
|
12,539,461
|
Prepaid expenses and other assets |
151,858
|
441,786
|
Inventory |
790,716
|
(3,656,463)
|
Deferred revenue |
349,499
|
(150,000)
|
Income taxes payable |
178,441
|
(1,822,977)
|
Accounts payable, accrued expenses and other liabilities |
1,356,330
|
(802,955)
|
Net cash (used in) provided by operating activities |
(17,303,239)
|
10,578,544
|
Cash flows from investing activities |
|
|
Purchases of property and equipment |
(900,704)
|
(1,134,208)
|
Proceeds from maturities of marketable investment securities |
90,279,227
|
6,223,740
|
Purchases of marketable securities |
(83,604,933)
|
(9,950,824)
|
Net cash (used in) provided by investing activities |
5,773,590
|
(4,861,292)
|
Cash flows from financing activities |
|
|
Proceeds from exercise of options and warrants |
|
177,870
|
Repurchases of common stock |
(1,204,256)
|
(12,994,373)
|
Net cash (used in) financing activities |
(1,204,256)
|
(12,816,503)
|
Net (decrease) in cash and cash equivalents |
(12,733,905)
|
(7,099,251)
|
Cash and cash equivalents at beginning of period |
22,973,803
|
88,607,234
|
Cash and cash equivalents at end of period |
10,239,898
|
81,507,983
|
Supplemental disclosure of cash flow information |
|
|
Interest paid |
|
|
Income taxes paid |
49,197
|
4,496,239
|
Supplemental disclosure of non-cash investing and financing transactions |
|
|
Inventory moved to property, plant and equipment |
673
|
218,906
|
Right-of-use assets obtained in exchange for new operating lease liabilities |
3,063,782
|
681,327
|
Business acquisition measurement period adjustments |
|
$ 681,728
|
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v3.23.3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Preferred Stock [Member]
Convertible Preferred Stock [Member]
|
Common Stock [Member] |
Treasury Stock, Common [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
|
$ 33,820
|
|
$ 80,271,999
|
|
$ 54,169,279
|
$ 134,475,100
|
Balance, shares at Dec. 31, 2021 |
|
33,819,862
|
|
|
|
|
|
Stock-based compensation |
|
$ 69
|
|
1,375,028
|
|
|
1,375,097
|
Stock-based compensation, shares |
|
68,750
|
|
|
|
|
|
Net loss |
|
|
|
|
|
11,714,595
|
11,714,595
|
Common stock issued for option exercises |
|
$ 45
|
|
49,956
|
|
|
50,001
|
Common stock issued for option exercises, shares |
|
45,456
|
|
|
|
|
|
Common stock issued for warrant exercises |
|
$ 50
|
|
99,950
|
|
|
100,000
|
Common stock issued for warrant exercises, shares |
|
50,000
|
|
|
|
|
|
Balance at Mar. 31, 2022 |
|
$ 33,984
|
|
81,796,933
|
|
65,883,874
|
147,714,793
|
Balance, shares at Mar. 31, 2022 |
|
33,984,068
|
|
|
|
|
|
Balance at Dec. 31, 2021 |
|
$ 33,820
|
|
80,271,999
|
|
54,169,279
|
134,475,100
|
Balance, shares at Dec. 31, 2021 |
|
33,819,862
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
7,667,231
|
Balance at Sep. 30, 2022 |
|
$ 34,332
|
(12,994,373)
|
86,068,948
|
|
61,836,508
|
134,945,417
|
Balance, shares at Sep. 30, 2022 |
|
34,332,182
|
|
|
|
|
|
Balance at Mar. 31, 2022 |
|
$ 33,984
|
|
81,796,933
|
|
65,883,874
|
147,714,793
|
Balance, shares at Mar. 31, 2022 |
|
33,984,068
|
|
|
|
|
|
Stock-based compensation |
|
$ 215
|
|
1,533,069
|
|
|
1,533,284
|
Stock-based compensation, shares |
|
215,583
|
|
|
|
|
|
Repurchases of common stock |
|
|
(2,599,478)
|
|
|
|
(2,599,478)
|
Net loss |
|
|
|
|
|
(2,686,304)
|
(2,686,304)
|
Common stock issued for option exercises |
|
$ 25
|
|
27,844
|
|
|
27,869
|
Common stock issued for option exercises, shares |
|
25,335
|
|
|
|
|
|
Common stock issued for acquisitions |
|
$ 89
|
|
480,687
|
|
|
480,776
|
Common stock issued for acquisitions, shares |
|
88,446
|
|
|
|
|
|
Balance at Jun. 30, 2022 |
|
$ 34,313
|
(2,599,478)
|
83,838,533
|
|
63,197,570
|
144,470,940
|
Balance, shares at Jun. 30, 2022 |
|
34,313,432
|
|
|
|
|
|
Stock-based compensation |
|
$ 19
|
|
2,230,415
|
|
|
2,230,434
|
Repurchases of common stock |
|
|
(10,394,895)
|
|
|
|
(10,394,895)
|
Net loss |
|
|
|
|
|
(1,361,062)
|
(1,361,062)
|
Balance at Sep. 30, 2022 |
|
$ 34,332
|
(12,994,373)
|
86,068,948
|
|
61,836,508
|
134,945,417
|
Balance, shares at Sep. 30, 2022 |
|
34,332,182
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 34,754
|
(14,211,866)
|
88,472,935
|
293,140
|
39,931,031
|
114,519,994
|
Balance, shares at Dec. 31, 2022 |
|
34,754,265
|
|
|
|
|
|
Stock-based compensation |
|
$ 69
|
|
2,168,673
|
|
|
2,168,742
|
Stock-based compensation, shares |
|
68,750
|
|
|
|
|
|
Repurchases of common stock |
|
|
(482,196)
|
|
|
|
(482,196)
|
Other comprehensive income, net of tax |
|
|
|
|
178,621
|
|
178,621
|
Net loss |
|
|
|
|
|
(5,755,391)
|
(5,755,391)
|
Balance at Mar. 31, 2023 |
|
$ 34,823
|
(14,694,062)
|
90,641,608
|
471,761
|
34,175,640
|
110,629,770
|
Balance, shares at Mar. 31, 2023 |
|
34,823,015
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 34,754
|
(14,211,866)
|
88,472,935
|
293,140
|
39,931,031
|
114,519,994
|
Balance, shares at Dec. 31, 2022 |
|
34,754,265
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
$ (20,656,410)
|
Common stock issued for option exercises, shares |
|
|
|
|
|
|
|
Balance at Sep. 30, 2023 |
|
$ 35,367
|
(15,416,122)
|
94,983,030
|
612,649
|
19,274,621
|
$ 99,489,545
|
Balance, shares at Sep. 30, 2023 |
|
35,367,100
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 34,823
|
(14,694,062)
|
90,641,608
|
471,761
|
34,175,640
|
110,629,770
|
Balance, shares at Mar. 31, 2023 |
|
34,823,015
|
|
|
|
|
|
Stock-based compensation |
|
$ 525
|
|
2,169,276
|
|
|
2,169,801
|
Stock-based compensation, shares |
|
525,335
|
|
|
|
|
|
Repurchases of common stock |
|
|
(555,734)
|
|
|
|
(555,734)
|
Other comprehensive income, net of tax |
|
|
|
|
107,366
|
|
107,366
|
Net loss |
|
|
|
|
|
(8,918,825)
|
(8,918,825)
|
Balance at Jun. 30, 2023 |
|
$ 35,348
|
(15,249,796)
|
92,810,884
|
579,127
|
25,256,815
|
103,432,378
|
Balance, shares at Jun. 30, 2023 |
|
35,348,350
|
|
|
|
|
|
Stock-based compensation |
|
$ 19
|
|
2,172,146
|
|
|
2,172,165
|
Stock-based compensation, shares |
|
18,750
|
|
|
|
|
|
Repurchases of common stock |
|
|
(166,326)
|
|
|
|
(166,326)
|
Other comprehensive income, net of tax |
|
|
|
|
33,522
|
|
33,522
|
Net loss |
|
|
|
|
|
(5,982,194)
|
(5,982,194)
|
Balance at Sep. 30, 2023 |
|
$ 35,367
|
$ (15,416,122)
|
$ 94,983,030
|
$ 612,649
|
$ 19,274,621
|
$ 99,489,545
|
Balance, shares at Sep. 30, 2023 |
|
35,367,100
|
|
|
|
|
|
X |
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v3.23.3
Overview and Basis of Presentation
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Overview and Basis of Presentation |
Note
1 – Overview and Basis of Presentation
Description
of Business
Co-Diagnostics,
Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic
tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including robust and innovative molecular
tools for detection of infectious diseases and agricultural applications. In connection with the sale of our tests we may sell diagnostic
equipment from other manufacturers as self-contained lab systems (which we refer to as the “MDx Device”). We are also developing
a unique, groundbreaking portable PCR device and proprietary test cups (the “Co-Dx™ PCR platform”) that have been designed
to bring affordable, reliable polymerase chain reaction (“PCR”) to patients in point-of-care and at-home settings. This platform
is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing.
There is no guarantee the Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory
approval is received, we will be able to successfully commercialize this platform.
Unaudited
Condensed Consolidated Financial Statements
The
accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q as they are
prescribed for smaller reporting companies. Accordingly, they do not include all the information and footnotes required by accounting
principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary to make the financial statements not misleading have been included. Operating
results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for
the year ending December 31, 2023. These statements should be read in conjunction with the Company’s audited financial statements
and related notes for the year ended December 31, 2022, included in the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission (the “SEC”) on March 16, 2023.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include receivables
and other long-lived assets, legal contingencies, income taxes, share based arrangements, and others. These estimates and assumptions
are based on management’s best estimates and judgments. Actual amounts and results could differ from those estimates.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
2 – Summary of Significant Accounting Policies
Reclassifications
Certain
prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact
on the previously reported results.
Cash
and Cash Equivalents
Cash
and cash equivalents consist of cash on hand, money market funds and highly liquid investments with an original maturity date of 90 days
or less from the date of purchase. The fair value of cash equivalents approximated their carrying value as of September 30, 2023 and
December 31, 2022. The Company has its cash and cash equivalents with large creditworthy financial
institutions and the balance exceeded federally insured limits. The Company has not experienced any losses in such accounts, and management
believes the Company is not exposed to any significant credit risk on cash and cash equivalents.
Marketable
Investment Securities
The
Company’s marketable investment securities are comprised of investments in certificates of deposit and U.S. Treasury bills and
notes. The Company designates investments in debt securities as available-for-sale. Available-for-sale debt securities with original
maturities of three months or less from the date of purchase are classified within cash and cash equivalents. Available-for-sale debt
securities with original maturities longer than three months are available to fund current operations and are classified as marketable
investment securities, within current assets on the condensed consolidated balance sheets. The Company may sell these securities at any
time for use in its current operations or for other purposes, even prior to maturity. Available-for-sale debt securities are reported
at fair value with the related unrealized gains and losses included in accumulated other comprehensive income (loss), a component of
stockholders’ equity, net of tax. Realized gains and losses on the sale of marketable investment securities are determined using
the average cost method on a first-in, first-out basis and recorded in total other income (expense), net in the condensed consolidated
statements of operations and comprehensive income (loss).
The
available-for-sale debt securities are subject to a periodic impairment review. For investments in an unrealized loss position, the Company
writes down the amortized cost basis of the investment if it is more likely than not that the Company will be required or will intend
to sell the investment before recovery of its amortized cost basis. For investments not likely to be sold before recovery of the amortized
cost basis, the Company determines whether a credit loss exists by considering information about the collectability of the instrument,
current market conditions, and reasonable and supportable forecasts of economic conditions. The Company recognizes an allowance for credit
losses up to the amount of the unrealized loss when appropriate. Allowances for credit losses and write-downs are recognized in total
other income (expense), net, and unrealized losses not related to credit losses are recognized in accumulated other comprehensive income
(loss). There are no allowances for credit losses recorded for the periods presented.
Accounts
Receivable
Trade
accounts receivable are recorded at the invoiced amount less estimates for credit losses. Management determines the allowance for credit
losses by specifically identifying troubled accounts and by using historical write off experience, adjusted for current market conditions,
customers’ financial condition and payment patterns, and reasonable supportable forecasts of future economic conditions, applied
to an aging of all other accounts. Account balances are written off against the allowance once the receivable is deemed uncollectible.
Recoveries of trade receivables previously written off are recorded when collected. At September 30, 2023, total accounts receivable
was $4,231,877 with an allowance for credit losses of $3,425,173 resulting in a net amount of $806,704. At December 31, 2022, total accounts
receivable was $6,552,249 with an allowance for credit losses of $3,098,526 resulting in a net amount of $3,453,723.
Equity-Method
Investments
The
Company’s equity method investments are initially recorded at cost and are included in other long-term assets in the accompanying
condensed consolidated balance sheet. The Company adjusts the carrying value of its investment based on our share of the earnings or
losses in the periods which they are reported by the investee until the carrying amount is zero. The earnings or losses are included
in other income (expense) in the accompanying condensed consolidated statements of operations.
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At September 30, 2023, the Company had $4,520,430 in inventory, comprised of $788,104
of finished goods, and $3,732,326 of raw materials. At December 31, 2022, the Company had $5,310,473 in inventory, of which $1,327,264
was finished goods and $3,983,209 was raw materials. The Company establishes reserves to reduce slow-moving, obsolete, or unusable inventories
to their estimated useful or scrap values.
Intangible
Assets
Indefinite-lived
intangible assets are not amortized, but rather tested for impairment at least annually on December 31, or more often if and when circumstances
indicate that the carrying value may not be recoverable. Finite-lived intangible assets are amortized over their useful lives.
Long-lived
Assets
Long-lived
assets, such as property and equipment, are stated at cost less accumulated depreciation and amortization. Depreciation is provided using
the straight-line method over the estimated useful lives of the property, generally from three to five years. Repairs and maintenance
costs are expensed as incurred except when such repairs significantly add to the useful life or productive capacity of the asset, in
which case the repairs are capitalized.
The
Company reviews its long-lived assets, including property and equipment, finite-lived intangible assets, and right-of-use (ROU) assets,
for impairment whenever an event or change in facts and circumstances indicates that their carrying amounts may not be recoverable. Recoverability
of these assets is measured by comparing the carrying amount to the estimated undiscounted future cash flows expected to be generated.
If the carrying amount exceeds the undiscounted cash flows, the assets are determined to be impaired and an impairment charge is recognized
as the amount by which the carrying amount exceeds fair value.
Business
Combinations
The
Company estimates the fair value of assets acquired and liabilities assumed in a business combination. Goodwill as of the acquisition
date is measured as the excess of consideration transferred over the net of the acquisition date fair values of the assets acquired and
the liabilities assumed. Such valuations require management to make significant estimates and assumptions, especially with respect to
intangible assets. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently
uncertain and unpredictable, and as a result, actual results may differ from estimates.
Leases
The
Company adopted ASC 842, Leases (“ASC 842”) effective January 1, 2022. Under ASC 842, the Company determines if an arrangement
is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to
control the identified asset. Right-of-use (ROU) assets represent the Company’s right to use an underlying asset for the lease
term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities
are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are
based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude
lease incentives and initial direct costs incurred, as applicable.
As
the implicit rate in the Company’s leases is generally unknown, the Company uses its incremental borrowing rate based on the information
available at the lease commencement date in determining the present value of future lease payments. The Company considers its credit
risk, term of the lease, total lease payments and adjusts for the impacts of collateral, as necessary, when calculating its incremental
borrowing rates. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it
is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. Lease costs for
the Company’s operating leases are recognized on a straight-line basis within operating expenses and cost of revenue over the reasonably
assured lease term.
The
Company has elected to not separate lease and non-lease components for leases of office space and, as a result, accounts for any lease
and non-lease components for office space as a single lease component, to the extent they are fixed. Non-lease components that are not
fixed are expensed as incurred as variable lease payments. The Company’s office leases typically include non-lease components such
as common-area maintenance costs. The Company has also elected to not apply the recognition requirement to any leases within its existing
classes of assets with a term of 12 months or less.
Revenue
Recognition
The
Company generates revenue from customers from product and license sales. The Company recognizes revenue from customers when all of the
following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether
the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii)
measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to
the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.
The
Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company
records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.
Grant
Funding
The
Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for grants
by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”). Revenues from
grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms of the specific
agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue in the condensed
consolidated statements of operations and comprehensive income (loss).
The
Company recognizes grant funding with conditions or continuing performance obligations as deferred revenue in the condensed consolidated
balance sheets if the conditions or performance obligations have not yet been met.
The
Company recognized grant funding revenue of $2.3 million during the three and nine months ended September 30, 2023. At September 30,
2023, the Company has also recorded $0.3 million of deferred revenue related to grant funding for which the underlying conditions or
performance obligations have not yet been met. Cash received from federal grants, contracts, and awards can be subject to audit by the
grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.
Deferred
Revenue
Deferred
revenue primarily consists of payments received from customers related to product sales or from granting agencies for services to be
rendered under research and development grants, prior to the Company fulfilling its performance obligation of providing the product or
performing research and development activities under the grant agreement. When this occurs, the Company records a contract liability
as deferred revenue. Deferred revenue is recognized as revenue as the related performance obligations are satisfied.
Research
and Development
Research
and development costs are expensed when incurred. For the three and nine months ended September 30, 2023, the Company expensed $5,788,789
and $16,783,892 of research and development costs, respectively. For the three and nine months ended September 30, 2022, the Company
expensed $5,037,461 and $12,698,632, respectively.
Stock-based
Compensation
The
Company has granted stock-based awards, including restricted stock, stock options, stock warrants and restricted stock units (“RSUs”),
to its employees, certain consultants and members of its board of directors. The Company records stock-based compensation based on the
grant date fair value of the awards and recognizes the fair value of those awards as expense using the straight-line method over the
requisite service period of the award. The Company estimates the grant date fair value of stock options using the Black-Scholes option-pricing
model. When an award is forfeited prior to the vesting date, the Company recognizes an adjustment
for the previously recognized expense in the period of the forfeiture.
Income
Taxes
The
Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred
income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and
tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes
only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the
taxing authority.
Valuation
allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing
the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income
and ongoing tax planning strategies.
Developing
the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant
judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income
tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and
tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the condensed consolidated
financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the condensed consolidated
financial positions, result of operations, or cash flows.
Net
Income (Loss) per Share
Basic
net income or loss per common share is computed by dividing net income or loss applicable to common shareholders by the weighted average
number of shares outstanding during each period.
Diluted
net income or loss per share is computed by dividing net income or loss attributable to common stockholders by the weighted-average number
of shares of common stock outstanding during the period increased by common shares that could be issued upon conversion or exercise of
other outstanding securities to the extent those additional common shares would be dilutive. The dilutive effect of potentially dilutive
securities is reflected in diluted net income or loss per share by application of the treasury stock method. During periods when the
Company is in a net loss position, basic net loss per share is the same as diluted net loss per share as the effects of potentially dilutive
securities are anti-dilutive.
Comprehensive
Income (Loss)
Comprehensive
income is comprised of unrealized gains and losses on marketable investment securities, net of income taxes.
Concentrations
Risk and Significant Customers
The
Company had certain customers which were each responsible for generating 10% or more of the total revenue for the three and nine months
ended September 30, 2023. Three customers accounted for approximately 47% of product revenue for the three months ended September 30,
2023, and two customers accounted for approximately 28% of product revenue for the nine months ended September 30, 2023. One granting
agency accounted for approximately 94% of grant revenue for the three and nine months ended September 30, 2023. One customer accounted
for approximately 52% of product revenue for the three months ended September 30, 2022, and two customers accounted for approximately
47% of product revenue for the nine months ended September 30, 2022.
Two
customers accounted for more than 10% of accounts receivable at September 30, 2023 and three customers accounted for more than 10% of
accounts receivable at December 31, 2022. These customers together accounted for approximately 71% and 37% of accounts receivable at
September 30, 2023 and December 31, 2022, respectively.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted
by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards,
which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
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v3.23.3
Cash, Cash Equivalents, and Financial Instruments
|
9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Cash, Cash Equivalents, and Financial Instruments |
Note
3 - Cash, Cash Equivalents, and Financial Instruments
The
following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:
Schedule
of Cash, Cash Equivalents and Marketable Investment Securities
| |
September 30, 2023 | |
| |
Adjusted Cost | | |
Allowance for Credit Losses | | |
Total Unrealized Gains / (Losses) | | |
Fair
Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash and cash equivalents | |
$ | (222,480 | ) | |
$ | - | | |
$ | - | | |
$ | (222,480 | ) | |
$ | (222,480 | ) | |
$ | - | |
Level 1: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 10,462,378 | | |
| - | | |
| - | | |
| 10,462,378 | | |
| 10,462,378 | | |
| - | |
Subtotal | |
| 10,462,378 | | |
| - | | |
| - | | |
| 10,462,378 | | |
| 10,462,378 | | |
| - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 52,375,675 | | |
| - | | |
| 813,324 | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Subtotal | |
| 52,375,675 | | |
| - | | |
| 813,324 | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Total | |
$ | 62,615,573 | | |
$ | - | | |
$ | 813,324 | | |
$ | 63,428,897 | | |
$ | 10,239,898 | | |
$ | 53,188,999 | |
| |
December 31, 2022 | |
| |
Adjusted Cost | | |
Allowance for Credit Losses | | |
Total Unrealized Gains / (Losses) | | |
Fair
Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash and cash equivalents | |
$ | 12,834,444 | | |
$ | - | | |
$ | - | | |
$ | 12,834,444 | | |
$ | 12,834,444 | | |
$ | - | |
Level 1: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 146,359 | | |
| - | | |
| - | | |
| 146,359 | | |
| 146,359 | | |
| - | |
Subtotal | |
| 146,359 | | |
| - | | |
| - | | |
| 146,359 | | |
| 146,359 | | |
| - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 67,892,825 | | |
| - | | |
| 389,241 | | |
| 68,282,066 | | |
| 9,993,000 | | |
| 58,289,066 | |
Subtotal | |
| 67,892,825 | | |
| - | | |
| 389,241 | | |
| 68,282,066 | | |
| 9,993,000 | | |
| 58,289,066 | |
Total | |
$ | 80,873,628 | | |
$ | - | | |
$ | 389,241 | | |
$ | 81,262,869 | | |
$ | 22,973,803 | | |
$ | 58,289,066 | |
Marketable
investment securities held as of September 30, 2023 mature over the next 12 months.
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v3.23.3
Intangible Assets, Net
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets, Net |
Note 4 – Intangible Assets, Net
Intangible assets, net consisted of the following:
Schedule
of Intangible Assets, Net
| |
September 30, 2023 | |
| |
| Weighted-Average Useful Life (1) (in Years) | | |
| Gross Carrying Amount | | |
| Accumulated Amortization | | |
| Net
Carrying Amount | |
In-process research and development | |
| Indefinite | | |
$ | 26,101,000 | | |
$ | - | | |
$ | 26,101,000 | |
Non-competition agreements | |
| 2.7 | | |
| 1,094,000 | | |
| (715,667 | ) | |
| 378,333 | |
Total intangible assets | |
| | | |
$ | 27,195,000 | | |
$ | (715,667 | ) | |
$ | 26,479,333 | |
| |
December 31, 2022 | |
| |
Weighted-Average | | |
Gross | | |
| | |
Net | |
| |
Useful Life (1) | | |
Carrying | | |
Accumulated | | |
Carrying | |
| |
(in Years) | | |
Amount | | |
Amortization | | |
Amount | |
In-process research and development | |
| Indefinite | | |
$ | 26,101,000 | | |
$ | - | | |
$ | 26,101,000 | |
Non-competition agreements | |
| 2.7 | | |
| 1,094,000 | | |
| (426,667 | ) | |
| 667,333 | |
Total intangible assets | |
| | | |
$ | 27,195,000 | | |
$ | (426,667 | ) | |
$ | 26,768,333 | |
|
(1) |
Based on weighted-average useful life established as of the acquisition date. |
The expected future annual amortization expense of the Company’s
intangible assets held as of September 30, 2023 is as follows:
Schedule
of Future Amortization Expense
Year Ending December 31, | |
Amortization Expense | |
2023 (remainder) | |
| 75,665 | |
2024 | |
| 302,668 | |
Total | |
$ | 378,333 | |
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v3.23.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
Note 5 – Fair Value Measurements
The Company measures and records certain financial
assets and liabilities at fair value on a recurring basis. Fair value is based on the price that would be received from selling an asset
or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
The following three levels of inputs are used to measure
the fair value of financial assets and liabilities:
Level 1: Quoted market prices
in active markets for identical assets or liabilities.
Level 2: Observable market-based
inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs
that are not corroborated by market data.
The following table summarizes the assets and liabilities
measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022, by level within the fair value hierarchy:
Schedule
of Fair Value Assets and Liabilities
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
September 30, 2023 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents | |
$ | 9,722,890 | | |
$ | - | | |
$ | - | | |
$ | 9,722,890 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Total assets measured at fair value | |
$ | 9,722,890 | | |
$ | 53,188,999 | | |
$ | - | | |
$ | 62,911,889 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 1,051,229 | | |
$ | 1,051,229 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| 143,754 | | |
| 143,754 | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 1,194,983 | | |
$ | 1,194,983 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
December 31, 2022 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents | |
$ | 186,667 | | |
$ | 9,993,000 | | |
$ | - | | |
$ | 10,179,667 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 58,289,066 | | |
| - | | |
| 58,289,066 | |
Total assets measured at fair value | |
$ | 186,667 | | |
$ | 68,282,066 | | |
$ | - | | |
$ | 68,468,733 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 2,499,147 | | |
$ | 2,499,147 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| 233,209 | | |
| 233,209 | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 2,732,356 | | |
$ | 2,732,356 | |
The Company’s financial instruments that are
measured at fair value on a recurring basis consist of U.S. treasury bills and notes as of September 30, 2023 and December 31, 2022.
In connection with the acquisitions of Idaho Molecular,
Inc. (IdMo) and Advanced Conceptions, Inc. (ACI) on December 31, 2021, the Company recorded a liability for contingent consideration in
the form of shares of common stock and warrants to purchase common stock. The fair value of contingent consideration is calculated using
a discounted probability weighted valuation model. Discount rates used in such calculations are a significant assumption that are not
observed in the market, and therefore, the resulting fair value represents a Level 3 measurement.
The changes for Level 3 items measured at fair value
on a recurring basis are as follows:
Schedule
of Changes in the Fair Value Measurement
| |
| | |
Fair value as of December 31, 2022 | |
$ | 2,732,356 | |
Change in fair value of contingent consideration issued for business acquisitions | |
| (1,537,373 | ) |
Fair value as of September 30, 2023 | |
$ | 1,194,983 | |
The fair value of the contingent consideration is
based on the fair value of the contingent consideration-common stock and contingent consideration-warrants. The fair value of the contingent
consideration-common stock is equal to the probability-adjusted value of the Company’s common stock as of the valuation date. The
fair value of the contingent consideration-warrants is equal to the probability adjusted value of a call option with terms consistent
with the terms of the warrants as of the valuation date. Prior to the probability adjustments, the warrants were valued based on the following
inputs:
Schedule
of Contingent Consideration Common Stock and Warrants
| |
September 30, 2023 | | |
December 31, 2022 | |
Stock price | |
$ | 1.06 | | |
$ | 2.52 | |
Strike price | |
$ | 9.13 | | |
$ | 9.13 | |
Volatility | |
| 125.00 | % | |
| 75.00 | % |
Risk-free rate | |
| 4.70 | % | |
| 4.10 | % |
Expected term (years) | |
| 3.3 | | |
| 4.0 | |
Fair Value of Other Financial Instruments
The carrying amounts of certain financial instruments,
including cash held in banks, accounts receivable, notes receivable, accounts payable, accrued liabilities, and other liabilities approximate
fair value due to their short-term maturities and are excluded from the fair value tables above.
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v3.23.3
Revenue
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
Note 6 – Revenue
The following table sets forth revenue by geographic
area:
Summary
of Revenue by Geographic Area
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
United States | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
$ | 88,107 | | |
$ | 4,699,444 | | |
$ | 618,491 | | |
$ | 23,425,186 | |
Grant revenue | |
| 2,320,565 | | |
| - | | |
| 2,320,565 | | |
| - | |
Total United States | |
| 2,408,672 | | |
| 4,699,444 | | |
| 2,939,056 | | |
| 23,425,186 | |
Rest of World | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
| 48,426 | | |
| 395,012 | | |
| 317,805 | | |
| 9,391,540 | |
Grant revenue | |
| - | | |
| - | | |
| - | | |
| - | |
Total Rest of World | |
| 48,426 | | |
| 395,012 | | |
| 317,805 | | |
| 9,391,540 | |
Total | |
$ | 2,457,098 | | |
$ | 5,094,456 | | |
$ | 3,256,861 | | |
$ | 32,816,726 | |
Revenue geographic area | |
$ | 2,457,098 | | |
$ | 5,094,456 | | |
$ | 3,256,861 | | |
$ | 32,816,726 | |
Percentage of revenue by area: | |
| | | |
| | | |
| | | |
| | |
United States | |
| 98 | % | |
| 92 | % | |
| 90 | % | |
| 71 | % |
Rest of World | |
| 2 | % | |
| 8 | % | |
| 10 | % | |
| 29 | % |
Deferred Revenue
Changes in the Company’s deferred revenue balance
for the nine months ended September 30, 2023 were as follows:
Schedule
of Deferred Revenue
Balance as of December 31, 2022 | |
$ | - | |
Increase due to prepayments from customers | |
| 19,620 | |
Increase due to grant funding awarded | |
| 329,879 | |
Balance as of September 30, 2023 | |
$ | 349,499 | |
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v3.23.3
Earnings (Loss) Per Share
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Earnings (Loss) Per Share |
Note 7 – Earnings (Loss) Per Share
The following table reconciles the numerator and the
denominator used to calculate basic and diluted earnings (loss) per share for three and nine months ended September 30, 2023 and 2022,
respectively:
Schedule
of Basis and Diluted Earnings Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net income (loss), as reported | |
$ | (5,982,194 | ) | |
$ | (1,361,062 | ) | |
$ | (20,656,410 | ) | |
$ | 7,667,231 | |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average shares, basic | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 32,109,213 | |
Dilutive effect of stock options, warrants and RSUs | |
| - | | |
| - | | |
| - | | |
| 893,326 | |
Shares used to compute diluted earnings per share | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 33,002,539 | |
| |
| | | |
| | | |
| | | |
| | |
Basic earnings (loss) per share | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.24 | |
Diluted earnings (loss) per share | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.23 | |
For the three and nine months ended September 30,
2022, potentially dilutive securities of 2,631,642 and 1,385,869 were excluded from the calculation because their effect would have been
anti-dilutive. The computation of basic and diluted earnings (loss) per share for the three and nine months ended September 30, 2023 and
2022, respectively, also excludes the approximately 1,400,000 shares of common stock and approximately 465,000 warrants to purchase shares
of common stock that are contingent upon the achievement of certain milestones.
As a result of incurring a net loss for the three
and nine months ended September 30, 2023, no potentially dilutive securities are included in the calculation of diluted earnings (loss)
per share because such effect would be anti-dilutive. The Company had potentially dilutive securities as of September 30, 2023, consisting
of: (i) 2,750,302 restricted stock units and (ii) 512,112 options.
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v3.23.3
Stock-Based Compensation
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-Based Compensation |
Note 8 – Stock-Based Compensation
Stock Incentive Plans
The Company’s board of directors adopted, and
shareholders approved, the Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive Plan (the “Incentive Plan”)
providing for the issuance of stock-based incentive awards to employees, officers, consultants, directors and independent contractors.
On August 31, 2022, the shareholders approved an increase in the number of awards available for issuance under the Incentive Plan to an
aggregate of 12,000,000 shares of common stock. The number of awards available for issuance under the Incentive Plan was 4,361,861 at
September 30, 2023.
Stock Options
The following table summarizes option activity during
the nine months ended September 30, 2023:
Schedule
of Option Activity
| |
Number of Options | | |
Weighted Average Exercise Price | | |
Weighted Average Fair Value | | |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding at December 31, 2022 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.88 | |
Granted | |
| - | | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| - | | |
| | |
Forfeited/Cancelled | |
| - | | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| - | | |
| | |
Outstanding at September 30, 2023 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.13 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at September 30, 2023 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.13 | |
The aggregate intrinsic value of outstanding options
at September 30, 2023 was approximately $0.1 million.
Stock-based compensation cost is measured at the grant
date based on the fair value of the award granted and recognized as expense over the vesting period using the straight-line method. The
Company uses the Black-Scholes model to value options granted. As of September 30, 2023, there were no unvested options and no unrecognized
stock-based compensation expense related to options.
Restricted Stock Units
The grant date fair value of RSUs granted is determined
using the closing market price of the Company’s common stock on the grant date with the associated compensation expense amortized
over the vesting period of the awards. The following table sets forth the outstanding RSUs and related activity for the nine months ended
September 30, 2023:
Schedule
of Outstanding Restricted Stock Units and Related Party
| |
Number of RSUs | | |
Weighted Average Grant Date Fair Value | |
Unvested at December 31, 2022 | |
| 2,426,725 | | |
$ | 6.95 | |
Granted | |
| 1,918,750 | | |
| 1.93 | |
Vested | |
| (612,835 | ) | |
| 7.24 | |
Forfeited/Cancelled | |
| (69,821 | ) | |
| 6.20 | |
Unvested at September 30, 2023 | |
| 3,662,819 | | |
$ | 4.29 | |
As of September 30, 2023, there was approximately
$11.5 million of unrecognized stock-based compensation expense related to outstanding RSUs which is expected to be recognized over a weighted-average
period of 1.9 years.
Warrants
The Company has issued warrants related to financings,
acquisitions and as compensation to third parties for services provided. The Company estimates the fair value of issued warrants on the
date of issuance as determined using a Black-Scholes pricing model. The Company amortizes the fair value of issued warrants using a vesting
schedule based on the terms and conditions of each warrant if granted for services.
The following table summarizes warrant activity during
the nine months ended September 30, 2023:
Schedule
of Warrant Activity
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Weighted Average Fair Value | | |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding at December 31, 2022 | |
| 485,000 | | |
$ | 8.81 | | |
$ | 2.43 | | |
| 4.0 | |
Granted | |
| - | | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| - | | |
| | |
Forfeited/Cancelled | |
| - | | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| - | | |
| | |
Outstanding at September 30, 2023 | |
| 485,000 | | |
$ | 8.81 | | |
$ | 0.92 | | |
| 3.2 | |
There were no warrants exercised during the nine months
ended September 30, 2023. The intrinsic value of warrants exercised during the nine months ended September 30, 2022 was approximately
$0.3 million. The aggregate intrinsic value of outstanding warrants at September 30, 2023 was approximately $0.
The total number of warrants exercisable at September
30, 2023 is 20,000. The ability to exercise the approximately 465,000 warrants issued in connection with acquisitions in prior years is
contingent upon the achievement of certain development and revenue milestones on or before January 1, 2027. There was no unrecognized
stock-based compensation expense related to warrants.
Stock-Based Compensation Expense
The Company recognized stock-based compensation expense
as follows:
Schedule
of Recognized Stock-based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of revenue | |
$ | 12,075 | | |
$ | 18,836 | | |
$ | 36,140 | | |
$ | 45,290 | |
Sales and marketing | |
| 564,962 | | |
| 526,159 | | |
| 1,666,868 | | |
| 1,340,716 | |
General and administrative | |
| 1,278,674 | | |
| 1,218,211 | | |
| 3,732,398 | | |
| 2,831,371 | |
Research and development | |
| 316,454 | | |
| 467,228 | | |
| 1,075,302 | | |
| 921,438 | |
Total stock-based compensation expense | |
$ | 2,172,165 | | |
$ | 2,230,434 | | |
$ | 6,510,708 | | |
$ | 5,138,815 | |
|
X |
- DefinitionTabular disclosure of share-based payment arrangement.
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
Note 9 – Income Taxes
For the three months ended September 30, 2023, the
Company recognized a benefit from income taxes of $2,113,581, representing an effective tax rate of 26.1%. For the nine months ended September
30, 2023, the Company recognized a benefit from income taxes of $6,611,712, representing an effective tax rate of 24.2%. The Company’s
effective tax rate will generally differ from the U.S. Federal statutory rate of 21.0% due to state taxes, permanent items, and discrete
items. For the three months ended September 30, 2022, the Company recognized a benefit from income taxes of $2,114,638. For the nine months
ended September 30, 2022, the Company recognized a benefit from income taxes of $1,470,058.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note 10 – Commitments and Contingencies
Lease Obligations
The Company leases office space under non-cancellable
operating leases and leases cancellable with one month notice. The Company expenses the cancellable leases in the period incurred in accordance
with the practical expedient elected. During the nine months ended September 30, 2023, the Company amended two operating leases to extend
the lease term and entered into one new operating lease. As a result, the Company recognized additional operating lease liabilities and
corresponding operating right-of-use assets of $3,063,782.
For the three and nine months ended September 30,
2023, components of lease expense are summarized as follows:
Schedule
of Lease Expense
| |
Three Months Ended
September 30, 2023 | | |
Nine Months Ended
September 30, 2023 | |
Operating lease costs | |
$ | 244,941 | | |
$ | 529,089 | |
Short-term lease costs | |
| 38,110 | | |
| 192,261 | |
Total lease costs | |
$ | 283,051 | | |
$ | 721,350 | |
As of September 30, 2023, the maturities of the Company’s
lease liabilities are as follows:
Schedule
of Maturities on Company Lease Liabilities
| |
Year Ending December 31, | |
2023 (remainder) | |
$ | 233,826 | |
2024 | |
| 966,451 | |
2025 | |
| 987,252 | |
2026 | |
| 682,806 | |
Thereafter | |
| 542,512 | |
Total lease payments | |
| 3,412,847 | |
Less: imputed interest | |
| 367,938 | |
Present value of operating lease liabilities | |
| 3,044,909 | |
Less: current portion | |
| 794,516 | |
Long-term portion | |
$ | 2,250,393 | |
Other information related to operating leases was
as follows:
Schedule
of Other Information Related to Operating Lease
| |
Nine Months Ended September 30, 2023 | |
Cash paid for operating leases included in operating cash flows | |
$ | 680,580 | |
Remaining lease term of operating leases | |
| 4 years | |
Discount rate of operating leases | |
| 6.2 | % |
Litigation
Liabilities for loss contingencies arising from claims,
assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and
the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.
The Company is a defendant in two class action claims
and three derivative actions claiming that the Company promulgated false and misleading press releases to increase the price of our stock
to improperly benefit the officers and directors of the Company. The plaintiffs demand compensatory damages sustained as a result of the
Company’s alleged wrongdoing in an amount to be proven at trial. The Company is also a party to two commercial litigation lawsuits
in which plaintiffs are claiming they are owned certain remuneration based on alleged agreements with the Company. The Company believes
these lawsuits are without merit and intends to defend the cases vigorously. The Company is unable to estimate a range of loss, if any,
that could result were there to be an adverse final decision in these cases. As of the date of this report, the Company does not believe
it is probable that these cases will result in an unfavorable outcome; however, if an unfavorable outcome were to occur in these cases,
it is possible that the impact could be material to the Company’s results of operations in the period(s) in which any such outcome
becomes probable and estimable.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.3
Share Repurchase Program
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Share Repurchase Program |
Note 11 – Share Repurchase Program
In March 2022, the Company’s Board of Directors
authorized a share repurchase program that would allow the Company to repurchase up to $30.0 million of CODX common stock. The repurchase
program does not obligate the Company to acquire any particular number of common shares, and the repurchase program may be suspended or
discontinued at any time at the Company’s discretion. The timing and amount of any share repurchases under the share repurchase
program will be determined by Co-Diagnostics’ management at its discretion based on ongoing assessments of the capital needs of
the business, the market price of the Company’s common stock, corporate and regulatory requirements, and general market conditions.
For accounting purposes, common stock repurchased
under the stock repurchase program is recorded based upon the transaction date of the applicable trade. Such repurchased shares are held
in treasury and are presented using the cost method. These shares are not retired and are considered issued but not outstanding. The following
table shows the changes in treasury stock (in shares) for the periods presented:
Schedule
of Treasury Stock
| |
Nine Months Ended | |
| |
September 30, 2023 | |
Balance, beginning of period | |
| 3,881,658 | |
Repurchases of common stock | |
| 826,862 | |
Balance, end of period | |
| 4,708,520 | |
|
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- DefinitionThe entire disclosure for equity.
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Note 12 – Subsequent Events
In October 2023, the Company was awarded additional
grant funding of approximately $9.0 million from one of the granting entities from whom the Company had previously been awarded grant
funding during the three months ended September 30, 2023. The first $3.5 million of funding under this grant was received by the Company
in October 2023.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Reclassifications |
Reclassifications
Certain
prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact
on the previously reported results.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
Cash
and cash equivalents consist of cash on hand, money market funds and highly liquid investments with an original maturity date of 90 days
or less from the date of purchase. The fair value of cash equivalents approximated their carrying value as of September 30, 2023 and
December 31, 2022. The Company has its cash and cash equivalents with large creditworthy financial
institutions and the balance exceeded federally insured limits. The Company has not experienced any losses in such accounts, and management
believes the Company is not exposed to any significant credit risk on cash and cash equivalents.
|
Marketable Investment Securities |
Marketable
Investment Securities
The
Company’s marketable investment securities are comprised of investments in certificates of deposit and U.S. Treasury bills and
notes. The Company designates investments in debt securities as available-for-sale. Available-for-sale debt securities with original
maturities of three months or less from the date of purchase are classified within cash and cash equivalents. Available-for-sale debt
securities with original maturities longer than three months are available to fund current operations and are classified as marketable
investment securities, within current assets on the condensed consolidated balance sheets. The Company may sell these securities at any
time for use in its current operations or for other purposes, even prior to maturity. Available-for-sale debt securities are reported
at fair value with the related unrealized gains and losses included in accumulated other comprehensive income (loss), a component of
stockholders’ equity, net of tax. Realized gains and losses on the sale of marketable investment securities are determined using
the average cost method on a first-in, first-out basis and recorded in total other income (expense), net in the condensed consolidated
statements of operations and comprehensive income (loss).
The
available-for-sale debt securities are subject to a periodic impairment review. For investments in an unrealized loss position, the Company
writes down the amortized cost basis of the investment if it is more likely than not that the Company will be required or will intend
to sell the investment before recovery of its amortized cost basis. For investments not likely to be sold before recovery of the amortized
cost basis, the Company determines whether a credit loss exists by considering information about the collectability of the instrument,
current market conditions, and reasonable and supportable forecasts of economic conditions. The Company recognizes an allowance for credit
losses up to the amount of the unrealized loss when appropriate. Allowances for credit losses and write-downs are recognized in total
other income (expense), net, and unrealized losses not related to credit losses are recognized in accumulated other comprehensive income
(loss). There are no allowances for credit losses recorded for the periods presented.
|
Accounts Receivable |
Accounts
Receivable
Trade
accounts receivable are recorded at the invoiced amount less estimates for credit losses. Management determines the allowance for credit
losses by specifically identifying troubled accounts and by using historical write off experience, adjusted for current market conditions,
customers’ financial condition and payment patterns, and reasonable supportable forecasts of future economic conditions, applied
to an aging of all other accounts. Account balances are written off against the allowance once the receivable is deemed uncollectible.
Recoveries of trade receivables previously written off are recorded when collected. At September 30, 2023, total accounts receivable
was $4,231,877 with an allowance for credit losses of $3,425,173 resulting in a net amount of $806,704. At December 31, 2022, total accounts
receivable was $6,552,249 with an allowance for credit losses of $3,098,526 resulting in a net amount of $3,453,723.
|
Equity-Method Investments |
Equity-Method
Investments
The
Company’s equity method investments are initially recorded at cost and are included in other long-term assets in the accompanying
condensed consolidated balance sheet. The Company adjusts the carrying value of its investment based on our share of the earnings or
losses in the periods which they are reported by the investee until the carrying amount is zero. The earnings or losses are included
in other income (expense) in the accompanying condensed consolidated statements of operations.
|
Inventory |
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At September 30, 2023, the Company had $4,520,430 in inventory, comprised of $788,104
of finished goods, and $3,732,326 of raw materials. At December 31, 2022, the Company had $5,310,473 in inventory, of which $1,327,264
was finished goods and $3,983,209 was raw materials. The Company establishes reserves to reduce slow-moving, obsolete, or unusable inventories
to their estimated useful or scrap values.
|
Intangible Assets |
Intangible
Assets
Indefinite-lived
intangible assets are not amortized, but rather tested for impairment at least annually on December 31, or more often if and when circumstances
indicate that the carrying value may not be recoverable. Finite-lived intangible assets are amortized over their useful lives.
|
Long-lived Assets |
Long-lived
Assets
Long-lived
assets, such as property and equipment, are stated at cost less accumulated depreciation and amortization. Depreciation is provided using
the straight-line method over the estimated useful lives of the property, generally from three to five years. Repairs and maintenance
costs are expensed as incurred except when such repairs significantly add to the useful life or productive capacity of the asset, in
which case the repairs are capitalized.
The
Company reviews its long-lived assets, including property and equipment, finite-lived intangible assets, and right-of-use (ROU) assets,
for impairment whenever an event or change in facts and circumstances indicates that their carrying amounts may not be recoverable. Recoverability
of these assets is measured by comparing the carrying amount to the estimated undiscounted future cash flows expected to be generated.
If the carrying amount exceeds the undiscounted cash flows, the assets are determined to be impaired and an impairment charge is recognized
as the amount by which the carrying amount exceeds fair value.
|
Business Combinations |
Business
Combinations
The
Company estimates the fair value of assets acquired and liabilities assumed in a business combination. Goodwill as of the acquisition
date is measured as the excess of consideration transferred over the net of the acquisition date fair values of the assets acquired and
the liabilities assumed. Such valuations require management to make significant estimates and assumptions, especially with respect to
intangible assets. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently
uncertain and unpredictable, and as a result, actual results may differ from estimates.
|
Leases |
Leases
The
Company adopted ASC 842, Leases (“ASC 842”) effective January 1, 2022. Under ASC 842, the Company determines if an arrangement
is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to
control the identified asset. Right-of-use (ROU) assets represent the Company’s right to use an underlying asset for the lease
term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities
are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are
based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and exclude
lease incentives and initial direct costs incurred, as applicable.
As
the implicit rate in the Company’s leases is generally unknown, the Company uses its incremental borrowing rate based on the information
available at the lease commencement date in determining the present value of future lease payments. The Company considers its credit
risk, term of the lease, total lease payments and adjusts for the impacts of collateral, as necessary, when calculating its incremental
borrowing rates. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it
is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. Lease costs for
the Company’s operating leases are recognized on a straight-line basis within operating expenses and cost of revenue over the reasonably
assured lease term.
The
Company has elected to not separate lease and non-lease components for leases of office space and, as a result, accounts for any lease
and non-lease components for office space as a single lease component, to the extent they are fixed. Non-lease components that are not
fixed are expensed as incurred as variable lease payments. The Company’s office leases typically include non-lease components such
as common-area maintenance costs. The Company has also elected to not apply the recognition requirement to any leases within its existing
classes of assets with a term of 12 months or less.
|
Revenue Recognition |
Revenue
Recognition
The
Company generates revenue from customers from product and license sales. The Company recognizes revenue from customers when all of the
following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether
the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii)
measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to
the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.
The
Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company
records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.
|
Grant Funding |
Grant
Funding
The
Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for grants
by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”). Revenues from
grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms of the specific
agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue in the condensed
consolidated statements of operations and comprehensive income (loss).
The
Company recognizes grant funding with conditions or continuing performance obligations as deferred revenue in the condensed consolidated
balance sheets if the conditions or performance obligations have not yet been met.
The
Company recognized grant funding revenue of $2.3 million during the three and nine months ended September 30, 2023. At September 30,
2023, the Company has also recorded $0.3 million of deferred revenue related to grant funding for which the underlying conditions or
performance obligations have not yet been met. Cash received from federal grants, contracts, and awards can be subject to audit by the
grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.
|
Deferred Revenue |
Deferred
Revenue
Deferred
revenue primarily consists of payments received from customers related to product sales or from granting agencies for services to be
rendered under research and development grants, prior to the Company fulfilling its performance obligation of providing the product or
performing research and development activities under the grant agreement. When this occurs, the Company records a contract liability
as deferred revenue. Deferred revenue is recognized as revenue as the related performance obligations are satisfied.
|
Research and Development |
Research
and Development
Research
and development costs are expensed when incurred. For the three and nine months ended September 30, 2023, the Company expensed $5,788,789
and $16,783,892 of research and development costs, respectively. For the three and nine months ended September 30, 2022, the Company
expensed $5,037,461 and $12,698,632, respectively.
|
Stock-based Compensation |
Stock-based
Compensation
The
Company has granted stock-based awards, including restricted stock, stock options, stock warrants and restricted stock units (“RSUs”),
to its employees, certain consultants and members of its board of directors. The Company records stock-based compensation based on the
grant date fair value of the awards and recognizes the fair value of those awards as expense using the straight-line method over the
requisite service period of the award. The Company estimates the grant date fair value of stock options using the Black-Scholes option-pricing
model. When an award is forfeited prior to the vesting date, the Company recognizes an adjustment
for the previously recognized expense in the period of the forfeiture.
|
Income Taxes |
Income
Taxes
The
Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred
income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and
tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes
only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the
taxing authority.
Valuation
allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing
the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income
and ongoing tax planning strategies.
Developing
the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant
judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income
tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and
tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the condensed consolidated
financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the condensed consolidated
financial positions, result of operations, or cash flows.
|
Net Income (Loss) per Share |
Net
Income (Loss) per Share
Basic
net income or loss per common share is computed by dividing net income or loss applicable to common shareholders by the weighted average
number of shares outstanding during each period.
Diluted
net income or loss per share is computed by dividing net income or loss attributable to common stockholders by the weighted-average number
of shares of common stock outstanding during the period increased by common shares that could be issued upon conversion or exercise of
other outstanding securities to the extent those additional common shares would be dilutive. The dilutive effect of potentially dilutive
securities is reflected in diluted net income or loss per share by application of the treasury stock method. During periods when the
Company is in a net loss position, basic net loss per share is the same as diluted net loss per share as the effects of potentially dilutive
securities are anti-dilutive.
|
Comprehensive Income (Loss) |
Comprehensive
Income (Loss)
Comprehensive
income is comprised of unrealized gains and losses on marketable investment securities, net of income taxes.
|
Concentrations Risk and Significant Customers |
Concentrations
Risk and Significant Customers
The
Company had certain customers which were each responsible for generating 10% or more of the total revenue for the three and nine months
ended September 30, 2023. Three customers accounted for approximately 47% of product revenue for the three months ended September 30,
2023, and two customers accounted for approximately 28% of product revenue for the nine months ended September 30, 2023. One granting
agency accounted for approximately 94% of grant revenue for the three and nine months ended September 30, 2023. One customer accounted
for approximately 52% of product revenue for the three months ended September 30, 2022, and two customers accounted for approximately
47% of product revenue for the nine months ended September 30, 2022.
Two
customers accounted for more than 10% of accounts receivable at September 30, 2023 and three customers accounted for more than 10% of
accounts receivable at December 31, 2022. These customers together accounted for approximately 71% and 37% of accounts receivable at
September 30, 2023 and December 31, 2022, respectively.
|
Recently Issued Accounting Standards |
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted
by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards,
which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
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v3.23.3
Cash, Cash Equivalents, and Financial Instruments (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Cash, Cash Equivalents and Marketable Investment Securities |
The
following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:
Schedule
of Cash, Cash Equivalents and Marketable Investment Securities
| |
September 30, 2023 | |
| |
Adjusted Cost | | |
Allowance for Credit Losses | | |
Total Unrealized Gains / (Losses) | | |
Fair
Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash and cash equivalents | |
$ | (222,480 | ) | |
$ | - | | |
$ | - | | |
$ | (222,480 | ) | |
$ | (222,480 | ) | |
$ | - | |
Level 1: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 10,462,378 | | |
| - | | |
| - | | |
| 10,462,378 | | |
| 10,462,378 | | |
| - | |
Subtotal | |
| 10,462,378 | | |
| - | | |
| - | | |
| 10,462,378 | | |
| 10,462,378 | | |
| - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 52,375,675 | | |
| - | | |
| 813,324 | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Subtotal | |
| 52,375,675 | | |
| - | | |
| 813,324 | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Total | |
$ | 62,615,573 | | |
$ | - | | |
$ | 813,324 | | |
$ | 63,428,897 | | |
$ | 10,239,898 | | |
$ | 53,188,999 | |
| |
December 31, 2022 | |
| |
Adjusted Cost | | |
Allowance for Credit Losses | | |
Total Unrealized Gains / (Losses) | | |
Fair
Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash and cash equivalents | |
$ | 12,834,444 | | |
$ | - | | |
$ | - | | |
$ | 12,834,444 | | |
$ | 12,834,444 | | |
$ | - | |
Level 1: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
| 146,359 | | |
| - | | |
| - | | |
| 146,359 | | |
| 146,359 | | |
| - | |
Subtotal | |
| 146,359 | | |
| - | | |
| - | | |
| 146,359 | | |
| 146,359 | | |
| - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 67,892,825 | | |
| - | | |
| 389,241 | | |
| 68,282,066 | | |
| 9,993,000 | | |
| 58,289,066 | |
Subtotal | |
| 67,892,825 | | |
| - | | |
| 389,241 | | |
| 68,282,066 | | |
| 9,993,000 | | |
| 58,289,066 | |
Total | |
$ | 80,873,628 | | |
$ | - | | |
$ | 389,241 | | |
$ | 81,262,869 | | |
$ | 22,973,803 | | |
$ | 58,289,066 | |
|
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v3.23.3
Intangible Assets, Net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Assets, Net |
Intangible assets, net consisted of the following:
Schedule
of Intangible Assets, Net
| |
September 30, 2023 | |
| |
| Weighted-Average Useful Life (1) (in Years) | | |
| Gross Carrying Amount | | |
| Accumulated Amortization | | |
| Net
Carrying Amount | |
In-process research and development | |
| Indefinite | | |
$ | 26,101,000 | | |
$ | - | | |
$ | 26,101,000 | |
Non-competition agreements | |
| 2.7 | | |
| 1,094,000 | | |
| (715,667 | ) | |
| 378,333 | |
Total intangible assets | |
| | | |
$ | 27,195,000 | | |
$ | (715,667 | ) | |
$ | 26,479,333 | |
| |
December 31, 2022 | |
| |
Weighted-Average | | |
Gross | | |
| | |
Net | |
| |
Useful Life (1) | | |
Carrying | | |
Accumulated | | |
Carrying | |
| |
(in Years) | | |
Amount | | |
Amortization | | |
Amount | |
In-process research and development | |
| Indefinite | | |
$ | 26,101,000 | | |
$ | - | | |
$ | 26,101,000 | |
Non-competition agreements | |
| 2.7 | | |
| 1,094,000 | | |
| (426,667 | ) | |
| 667,333 | |
Total intangible assets | |
| | | |
$ | 27,195,000 | | |
$ | (426,667 | ) | |
$ | 26,768,333 | |
|
(1) |
Based on weighted-average useful life established as of the acquisition date. |
|
Schedule of Future Amortization Expense |
The expected future annual amortization expense of the Company’s
intangible assets held as of September 30, 2023 is as follows:
Schedule
of Future Amortization Expense
Year Ending December 31, | |
Amortization Expense | |
2023 (remainder) | |
| 75,665 | |
2024 | |
| 302,668 | |
Total | |
$ | 378,333 | |
|
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v3.23.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value Assets and Liabilities |
The following table summarizes the assets and liabilities
measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022, by level within the fair value hierarchy:
Schedule
of Fair Value Assets and Liabilities
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
September 30, 2023 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents | |
$ | 9,722,890 | | |
$ | - | | |
$ | - | | |
$ | 9,722,890 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 53,188,999 | | |
| - | | |
| 53,188,999 | |
Total assets measured at fair value | |
$ | 9,722,890 | | |
$ | 53,188,999 | | |
$ | - | | |
$ | 62,911,889 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 1,051,229 | | |
$ | 1,051,229 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| 143,754 | | |
| 143,754 | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 1,194,983 | | |
$ | 1,194,983 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
December 31, 2022 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents | |
$ | 186,667 | | |
$ | 9,993,000 | | |
$ | - | | |
$ | 10,179,667 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 58,289,066 | | |
| - | | |
| 58,289,066 | |
Total assets measured at fair value | |
$ | 186,667 | | |
$ | 68,282,066 | | |
$ | - | | |
$ | 68,468,733 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 2,499,147 | | |
$ | 2,499,147 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| 233,209 | | |
| 233,209 | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 2,732,356 | | |
$ | 2,732,356 | |
|
Schedule of Changes in the Fair Value Measurement |
The changes for Level 3 items measured at fair value
on a recurring basis are as follows:
Schedule
of Changes in the Fair Value Measurement
| |
| | |
Fair value as of December 31, 2022 | |
$ | 2,732,356 | |
Change in fair value of contingent consideration issued for business acquisitions | |
| (1,537,373 | ) |
Fair value as of September 30, 2023 | |
$ | 1,194,983 | |
|
Schedule of Contingent Consideration Common Stock and Warrants |
Schedule
of Contingent Consideration Common Stock and Warrants
| |
September 30, 2023 | | |
December 31, 2022 | |
Stock price | |
$ | 1.06 | | |
$ | 2.52 | |
Strike price | |
$ | 9.13 | | |
$ | 9.13 | |
Volatility | |
| 125.00 | % | |
| 75.00 | % |
Risk-free rate | |
| 4.70 | % | |
| 4.10 | % |
Expected term (years) | |
| 3.3 | | |
| 4.0 | |
|
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v3.23.3
Revenue (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Summary of Revenue by Geographic Area |
The following table sets forth revenue by geographic
area:
Summary
of Revenue by Geographic Area
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
United States | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
$ | 88,107 | | |
$ | 4,699,444 | | |
$ | 618,491 | | |
$ | 23,425,186 | |
Grant revenue | |
| 2,320,565 | | |
| - | | |
| 2,320,565 | | |
| - | |
Total United States | |
| 2,408,672 | | |
| 4,699,444 | | |
| 2,939,056 | | |
| 23,425,186 | |
Rest of World | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
| 48,426 | | |
| 395,012 | | |
| 317,805 | | |
| 9,391,540 | |
Grant revenue | |
| - | | |
| - | | |
| - | | |
| - | |
Total Rest of World | |
| 48,426 | | |
| 395,012 | | |
| 317,805 | | |
| 9,391,540 | |
Total | |
$ | 2,457,098 | | |
$ | 5,094,456 | | |
$ | 3,256,861 | | |
$ | 32,816,726 | |
Revenue geographic area | |
$ | 2,457,098 | | |
$ | 5,094,456 | | |
$ | 3,256,861 | | |
$ | 32,816,726 | |
Percentage of revenue by area: | |
| | | |
| | | |
| | | |
| | |
United States | |
| 98 | % | |
| 92 | % | |
| 90 | % | |
| 71 | % |
Rest of World | |
| 2 | % | |
| 8 | % | |
| 10 | % | |
| 29 | % |
|
Schedule of Deferred Revenue |
Changes in the Company’s deferred revenue balance
for the nine months ended September 30, 2023 were as follows:
Schedule
of Deferred Revenue
Balance as of December 31, 2022 | |
$ | - | |
Increase due to prepayments from customers | |
| 19,620 | |
Increase due to grant funding awarded | |
| 329,879 | |
Balance as of September 30, 2023 | |
$ | 349,499 | |
|
X |
- DefinitionTabular disclosure of receivable, contract asset, and contract liability from contract with customer. Includes, but is not limited to, change in contract asset and contract liability.
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v3.23.3
Earnings (Loss) Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Basis and Diluted Earnings Per Share |
The following table reconciles the numerator and the
denominator used to calculate basic and diluted earnings (loss) per share for three and nine months ended September 30, 2023 and 2022,
respectively:
Schedule
of Basis and Diluted Earnings Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net income (loss), as reported | |
$ | (5,982,194 | ) | |
$ | (1,361,062 | ) | |
$ | (20,656,410 | ) | |
$ | 7,667,231 | |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average shares, basic | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 32,109,213 | |
Dilutive effect of stock options, warrants and RSUs | |
| - | | |
| - | | |
| - | | |
| 893,326 | |
Shares used to compute diluted earnings per share | |
| 29,361,300 | | |
| 31,321,368 | | |
| 29,306,572 | | |
| 33,002,539 | |
| |
| | | |
| | | |
| | | |
| | |
Basic earnings (loss) per share | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.24 | |
Diluted earnings (loss) per share | |
$ | (0.20 | ) | |
$ | (0.04 | ) | |
$ | (0.70 | ) | |
$ | 0.23 | |
|
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v3.23.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Option Activity |
The following table summarizes option activity during
the nine months ended September 30, 2023:
Schedule
of Option Activity
| |
Number of Options | | |
Weighted Average Exercise Price | | |
Weighted Average Fair Value | | |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding at December 31, 2022 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.88 | |
Granted | |
| - | | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| - | | |
| | |
Forfeited/Cancelled | |
| - | | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| - | | |
| | |
Outstanding at September 30, 2023 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.13 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at September 30, 2023 | |
| 1,040,572 | | |
$ | 2.19 | | |
$ | 1.37 | | |
| 5.13 | |
|
Schedule of Outstanding Restricted Stock Units and Related Party |
The grant date fair value of RSUs granted is determined
using the closing market price of the Company’s common stock on the grant date with the associated compensation expense amortized
over the vesting period of the awards. The following table sets forth the outstanding RSUs and related activity for the nine months ended
September 30, 2023:
Schedule
of Outstanding Restricted Stock Units and Related Party
| |
Number of RSUs | | |
Weighted Average Grant Date Fair Value | |
Unvested at December 31, 2022 | |
| 2,426,725 | | |
$ | 6.95 | |
Granted | |
| 1,918,750 | | |
| 1.93 | |
Vested | |
| (612,835 | ) | |
| 7.24 | |
Forfeited/Cancelled | |
| (69,821 | ) | |
| 6.20 | |
Unvested at September 30, 2023 | |
| 3,662,819 | | |
$ | 4.29 | |
|
Schedule of Warrant Activity |
The following table summarizes warrant activity during
the nine months ended September 30, 2023:
Schedule
of Warrant Activity
| |
Number of Warrants | | |
Weighted Average Exercise Price | | |
Weighted Average Fair Value | | |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding at December 31, 2022 | |
| 485,000 | | |
$ | 8.81 | | |
$ | 2.43 | | |
| 4.0 | |
Granted | |
| - | | |
| - | | |
| - | | |
| | |
Expired | |
| - | | |
| - | | |
| - | | |
| | |
Forfeited/Cancelled | |
| - | | |
| - | | |
| - | | |
| | |
Exercised | |
| - | | |
| - | | |
| - | | |
| | |
Outstanding at September 30, 2023 | |
| 485,000 | | |
$ | 8.81 | | |
$ | 0.92 | | |
| 3.2 | |
|
Schedule of Recognized Stock-based Compensation Expense |
The Company recognized stock-based compensation expense
as follows:
Schedule
of Recognized Stock-based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of revenue | |
$ | 12,075 | | |
$ | 18,836 | | |
$ | 36,140 | | |
$ | 45,290 | |
Sales and marketing | |
| 564,962 | | |
| 526,159 | | |
| 1,666,868 | | |
| 1,340,716 | |
General and administrative | |
| 1,278,674 | | |
| 1,218,211 | | |
| 3,732,398 | | |
| 2,831,371 | |
Research and development | |
| 316,454 | | |
| 467,228 | | |
| 1,075,302 | | |
| 921,438 | |
Total stock-based compensation expense | |
$ | 2,172,165 | | |
$ | 2,230,434 | | |
$ | 6,510,708 | | |
$ | 5,138,815 | |
|
X |
- DefinitionTabular disclosure of activity for award under share-based payment arrangement. Includes, but is not limited to, outstanding award at beginning and end of year, granted, exercised, forfeited, and weighted-average grant date fair value.
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v3.23.3
Commitments and Contingencies (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Lease Expense |
For the three and nine months ended September 30,
2023, components of lease expense are summarized as follows:
Schedule
of Lease Expense
| |
Three Months Ended
September 30, 2023 | | |
Nine Months Ended
September 30, 2023 | |
Operating lease costs | |
$ | 244,941 | | |
$ | 529,089 | |
Short-term lease costs | |
| 38,110 | | |
| 192,261 | |
Total lease costs | |
$ | 283,051 | | |
$ | 721,350 | |
|
Schedule of Maturities on Company Lease Liabilities |
As of September 30, 2023, the maturities of the Company’s
lease liabilities are as follows:
Schedule
of Maturities on Company Lease Liabilities
| |
Year Ending December 31, | |
2023 (remainder) | |
$ | 233,826 | |
2024 | |
| 966,451 | |
2025 | |
| 987,252 | |
2026 | |
| 682,806 | |
Thereafter | |
| 542,512 | |
Total lease payments | |
| 3,412,847 | |
Less: imputed interest | |
| 367,938 | |
Present value of operating lease liabilities | |
| 3,044,909 | |
Less: current portion | |
| 794,516 | |
Long-term portion | |
$ | 2,250,393 | |
|
Schedule of Other Information Related to Operating Lease |
Other information related to operating leases was
as follows:
Schedule
of Other Information Related to Operating Lease
| |
Nine Months Ended September 30, 2023 | |
Cash paid for operating leases included in operating cash flows | |
$ | 680,580 | |
Remaining lease term of operating leases | |
| 4 years | |
Discount rate of operating leases | |
| 6.2 | % |
|
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v3.23.3
Share Repurchase Program (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Schedule of Treasury Stock |
Schedule
of Treasury Stock
| |
Nine Months Ended | |
| |
September 30, 2023 | |
Balance, beginning of period | |
| 3,881,658 | |
Repurchases of common stock | |
| 826,862 | |
Balance, end of period | |
| 4,708,520 | |
|
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v3.23.3
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Oct. 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Product Information [Line Items] |
|
|
|
|
|
|
Accounts receivable, before allowance for credit loss, current |
|
$ 4,231,877
|
|
$ 4,231,877
|
|
$ 6,552,249
|
Uncollectable accounts |
|
3,425,173
|
|
3,425,173
|
|
3,098,526
|
Accounts receivable, after allowance for credit loss, current |
|
806,704
|
|
806,704
|
|
3,453,723
|
Inventory, net |
|
4,520,430
|
|
4,520,430
|
|
5,310,473
|
Inventory, finished goods, gross |
|
788,104
|
|
788,104
|
|
1,327,264
|
Inventory, raw materials, gross |
|
3,732,326
|
|
3,732,326
|
|
$ 3,983,209
|
Grant funding revenue |
$ 9,000,000.0
|
2,300,000
|
|
2,300,000
|
|
|
Deferred revenue |
|
300,000
|
|
300,000
|
|
|
Research and development |
|
$ 5,788,789
|
$ 5,037,461
|
$ 16,783,892
|
$ 12,698,632
|
|
Customers [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
10.00%
|
|
10.00%
|
|
|
Three Customers [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
|
|
|
|
10.00%
|
Three Customers [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
47.00%
|
|
|
|
|
Two Customers [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
|
|
10.00%
|
|
|
Two Customers [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
|
|
28.00%
|
47.00%
|
|
One Granting Agency [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
94.00%
|
|
94.00%
|
|
|
One Customer [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
|
52.00%
|
|
|
|
Customers Together [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] |
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
Concentration risk percentage |
|
|
|
71.00%
|
|
37.00%
|
X |
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v3.23.3
Schedule of Cash, Cash Equivalents and Marketable Investment Securities (Details) - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] |
|
|
Adjusted Cost |
$ (62,615,573)
|
$ (80,873,628)
|
Allowance for Credit Losses |
|
|
Total Unrealized Gains / (Losses) |
813,324
|
389,241
|
Fair Value |
(63,428,897)
|
(81,262,869)
|
Cash and Cash Equivalents |
(10,239,898)
|
(22,973,803)
|
Marketable Securities |
53,188,999
|
58,289,066
|
Adjusted Cost |
62,615,573
|
80,873,628
|
Fair Value |
63,428,897
|
81,262,869
|
Cash and Cash Equivalents |
10,239,898
|
22,973,803
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Adjusted Cost |
(10,462,378)
|
(146,359)
|
Allowance for Credit Losses |
|
|
Total Unrealized Gains / (Losses) |
|
|
Fair Value |
(10,462,378)
|
(146,359)
|
Cash and Cash Equivalents |
(10,462,378)
|
(146,359)
|
Marketable Securities |
|
|
Adjusted Cost |
10,462,378
|
146,359
|
Fair Value |
10,462,378
|
146,359
|
Cash and Cash Equivalents |
10,462,378
|
146,359
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Adjusted Cost |
(52,375,675)
|
(67,892,825)
|
Allowance for Credit Losses |
|
|
Total Unrealized Gains / (Losses) |
813,324
|
389,241
|
Fair Value |
(53,188,999)
|
(68,282,066)
|
Cash and Cash Equivalents |
|
(9,993,000)
|
Marketable Securities |
53,188,999
|
58,289,066
|
Adjusted Cost |
52,375,675
|
67,892,825
|
Fair Value |
53,188,999
|
68,282,066
|
Cash and Cash Equivalents |
|
9,993,000
|
Cash [Member] |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Adjusted Cost |
(222,480)
|
(12,834,444)
|
Allowance for Credit Losses |
|
|
Total Unrealized Gains / (Losses) |
|
|
Fair Value |
(222,480)
|
(12,834,444)
|
Cash and Cash Equivalents |
(222,480)
|
(12,834,444)
|
Marketable Securities |
|
|
Adjusted Cost |
222,480
|
12,834,444
|
Fair Value |
222,480
|
12,834,444
|
Cash and Cash Equivalents |
222,480
|
12,834,444
|
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Adjusted Cost |
(10,462,378)
|
(146,359)
|
Allowance for Credit Losses |
|
|
Total Unrealized Gains / (Losses) |
|
|
Fair Value |
(10,462,378)
|
(146,359)
|
Cash and Cash Equivalents |
(10,462,378)
|
(146,359)
|
Marketable Securities |
|
|
Adjusted Cost |
10,462,378
|
146,359
|
Fair Value |
10,462,378
|
146,359
|
Cash and Cash Equivalents |
10,462,378
|
146,359
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Cash and Cash Equivalents [Line Items] |
|
|
Adjusted Cost |
(52,375,675)
|
(67,892,825)
|
Allowance for Credit Losses |
|
|
Total Unrealized Gains / (Losses) |
813,324
|
389,241
|
Fair Value |
(53,188,999)
|
(68,282,066)
|
Cash and Cash Equivalents |
|
(9,993,000)
|
Marketable Securities |
53,188,999
|
58,289,066
|
Adjusted Cost |
52,375,675
|
67,892,825
|
Fair Value |
53,188,999
|
68,282,066
|
Cash and Cash Equivalents |
|
$ 9,993,000
|
X |
- DefinitionAmount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation.
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v3.23.3
Schedule of Intangible Assets, Net (Details) - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] |
|
|
|
Intangible assets, gross |
|
$ 27,195,000
|
$ 27,195,000
|
Less accumulated amortization |
|
(715,667)
|
(426,667)
|
Intangible assets, net |
|
$ 26,479,333
|
$ 26,768,333
|
In Process Research and Development [Member] |
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
Estimated useful lives in years, term |
[1] |
Indefinite
|
Indefinite
|
Intangible assets, gross |
|
$ 26,101,000
|
$ 26,101,000
|
Less accumulated amortization |
|
|
|
Intangible assets, net |
|
26,101,000
|
26,101,000
|
Noncompete Agreements [Member] |
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
Intangible assets, gross |
|
1,094,000
|
1,094,000
|
Less accumulated amortization |
|
(715,667)
|
(426,667)
|
Intangible assets, net |
|
$ 378,333
|
$ 667,333
|
Estimated useful lives in years |
[1] |
2 years 8 months 12 days
|
2 years 8 months 12 days
|
|
|
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v3.23.3
Schedule of Fair Value Assets and Liabilities (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities (U.S. treasury bills and notes) |
$ 53,188,999
|
$ 58,289,066
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities (U.S. treasury bills and notes) |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities (U.S. treasury bills and notes) |
53,188,999
|
58,289,066
|
Fair Value, Recurring [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
9,722,890
|
10,179,667
|
Marketable securities (U.S. treasury bills and notes) |
53,188,999
|
58,289,066
|
Total assets measured at fair value |
62,911,889
|
68,468,733
|
Contingent consideration - common stock |
1,051,229
|
2,499,147
|
Contingent consideration - warrants |
143,754
|
233,209
|
Total liabilities measured at fair value |
1,194,983
|
2,732,356
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
9,722,890
|
186,667
|
Marketable securities (U.S. treasury bills and notes) |
|
|
Total assets measured at fair value |
9,722,890
|
186,667
|
Contingent consideration - common stock |
|
|
Contingent consideration - warrants |
|
|
Total liabilities measured at fair value |
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
|
9,993,000
|
Marketable securities (U.S. treasury bills and notes) |
53,188,999
|
58,289,066
|
Total assets measured at fair value |
53,188,999
|
68,282,066
|
Contingent consideration - common stock |
|
|
Contingent consideration - warrants |
|
|
Total liabilities measured at fair value |
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
|
|
Marketable securities (U.S. treasury bills and notes) |
|
|
Total assets measured at fair value |
|
|
Contingent consideration - common stock |
1,051,229
|
2,499,147
|
Contingent consideration - warrants |
143,754
|
233,209
|
Total liabilities measured at fair value |
$ 1,194,983
|
$ 2,732,356
|
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v3.23.3
Summary of Revenue by Geographic Area (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue geographic area |
$ 2,457,098
|
$ 5,094,456
|
$ 3,256,861
|
$ 32,816,726
|
UNITED STATES |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue geographic area |
$ 2,408,672
|
$ 4,699,444
|
$ 2,939,056
|
$ 23,425,186
|
UNITED STATES | Revenue Benchmark [Member] | Geographic Concentration Risk [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Percentage of revenue |
98.00%
|
92.00%
|
90.00%
|
71.00%
|
UNITED STATES | Product [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue geographic area |
$ 88,107
|
$ 4,699,444
|
$ 618,491
|
$ 23,425,186
|
UNITED STATES | Grant [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue geographic area |
2,320,565
|
|
2,320,565
|
|
Rest of World [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Revenue geographic area |
$ 48,426
|
$ 395,012
|
$ 317,805
|
$ 9,391,540
|
Rest of World [Member] | Revenue Benchmark [Member] | Geographic Concentration Risk [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Percentage of revenue |
2.00%
|
8.00%
|
10.00%
|
29.00%
|
Rest of World [Member] | Product [Member] |
|
|
|
|
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|
|
|
|
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$ 48,426
|
$ 395,012
|
$ 317,805
|
$ 9,391,540
|
Rest of World [Member] | Grant [Member] |
|
|
|
|
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|
|
|
|
Revenue geographic area |
|
|
|
|
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v3.23.3
Schedule of Basis and Diluted Earnings Per Share (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
|
|
|
|
Net income (loss), as reported |
$ (5,982,194)
|
$ (8,918,825)
|
$ (5,755,391)
|
$ (1,361,062)
|
$ (2,686,304)
|
$ 11,714,595
|
$ (20,656,410)
|
$ 7,667,231
|
Weighted average shares, basic |
29,361,300
|
|
|
31,321,368
|
|
|
29,306,572
|
32,109,213
|
Dilutive effect of stock options, warrants and RSUs |
|
|
|
|
|
|
|
893,326
|
Shares used to compute diluted earnings per share |
29,361,300
|
|
|
31,321,368
|
|
|
29,306,572
|
33,002,539
|
Basic earnings (loss) per share |
$ (0.20)
|
|
|
$ (0.04)
|
|
|
$ (0.70)
|
$ 0.24
|
Diluted earnings (loss) per share |
$ (0.20)
|
|
|
$ (0.04)
|
|
|
$ (0.70)
|
$ 0.23
|
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v3.23.3
Earnings (Loss) Per Share (Details Narrative) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Securities excluded from computation of diluted earnings per share |
0
|
2,631,642
|
0
|
1,385,869
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Securities excluded from computation of diluted earnings per share |
|
|
2,750,302
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Securities excluded from computation of diluted earnings per share |
|
|
512,112
|
|
Common Stock [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Securities excluded from computation of diluted earnings per share |
1,400,000
|
1,400,000
|
1,400,000
|
1,400,000
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Securities excluded from computation of diluted earnings per share |
|
|
465,000
|
|
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v3.23.3
Schedule of Option Activity (Details)
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Number of Options Outstanding, Beginning | shares |
1,040,572
|
Weighted Average Exercise Price Outstanding, Beginning |
$ 2.19
|
Weighted Average Fair Value Outstanding, Ending |
$ 1.37
|
Weighted-average Remaining Contractual Life (years) Outstanding, Beginning |
5 years 10 months 17 days
|
Number of Options Outstanding, Granted | shares |
|
Weighted Average Exercise Price Granted |
|
Weighted Average Fair Value Granted |
|
Number of Options Outstanding, Expired | shares |
|
Weighted Average Exercise Price Expired |
|
Weighted Average Fair Value Expired |
|
Number of Options Outstanding, Forfeited/Cancelled | shares |
|
Weighted Average Exercise Price Forfeited/Cancelled |
|
Weighted Average Fair Value Forfeited/Cancelled |
|
Number of Options Outstanding, Exercised | shares |
|
Weighted Average Exercise Price Exercised |
|
Weighted Average Fair Value Exercised |
|
Number of Options Outstanding, Ending | shares |
1,040,572
|
Weighted Average Exercise Price Outstanding, Ending |
$ 2.19
|
Weighted-average Remaining Contractual Life (years) Outstanding, Ending |
5 years 1 month 17 days
|
Number of Options Exercisable Ending | shares |
1,040,572
|
Weighted Average Exercise Price, Exercisable Ending |
$ 2.19
|
Weighted Average Fair Value, Exercisable Ending |
$ 1.37
|
Weighted-average Remaining Contractual Life (years), Exercisable Ending |
5 years 1 month 17 days
|
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v3.23.3
Schedule of Outstanding Restricted Stock Units and Related Party (Details) - Restricted Stock Units (RSUs) [Member]
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Restricted Stock Units, Outstanding Beginning | shares |
2,426,725
|
Weighted Average Grant Date Fair Value, Outstanding Beginning | $ / shares |
$ 6.95
|
Number of Restricted Stock Units, Granted | shares |
1,918,750
|
Weighted Average Grant Date Fair Value, Granted | $ / shares |
$ 1.93
|
Number of Restricted Stock Units, Vested | shares |
(612,835)
|
Weighted Average Grant Date Fair Value, Vested | $ / shares |
$ 7.24
|
Number of Restricted Stock Units, Forfeited/Cancelled | shares |
(69,821)
|
Weighted Average Grant Date Fair Value, Forfeited/Cancelled | $ / shares |
$ 6.20
|
Number of Restricted Stock Units, Outstanding Ending | shares |
3,662,819
|
Weighted Average Grant Date Fair Value, Outstanding Ending | $ / shares |
$ 4.29
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v3.23.3
Schedule of Warrant Activity (Details)
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Number of Warrants Outstanding, Beginning | shares |
485,000
|
Weighted Average Exercise Price, Beginning |
$ 8.81
|
Weighted Average fair value, Beginning |
$ 2.43
|
Weighted-average Remaining Contractual Life (Years) Outstanding |
4 years
|
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|
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|
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|
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|
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|
Weighted Average Fair Value, Forfeited/Cancelled |
|
Number of Warrants Outstanding, Exercised | shares |
|
Weighted Average Exercise Price, Exercised |
|
Weighted Average Fair Value, Exercised |
|
Number of Warrants Outstanding, Ending | shares |
485,000
|
Weighted Average Exercise Price, Ending |
$ 8.81
|
Weighted Average Fair Value, Ending |
$ 0.92
|
Weighted-average Remaining Contractual Life (Years) Outstanding |
3 years 2 months 12 days
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v3.23.3
Schedule of Recognized Stock-based Compensation Expense (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 2,172,165
|
$ 2,230,434
|
$ 6,510,708
|
$ 5,138,815
|
Cost Of Sale [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
12,075
|
18,836
|
36,140
|
45,290
|
Sales And Marketing [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
564,962
|
526,159
|
1,666,868
|
1,340,716
|
General And Administrative [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
1,278,674
|
1,218,211
|
3,732,398
|
2,831,371
|
Research And Development [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 316,454
|
$ 467,228
|
$ 1,075,302
|
$ 921,438
|
X |
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v3.23.3
Stock-Based Compensation (Details Narrative) - USD ($)
|
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Aug. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term |
5 years 1 month 17 days
|
|
|
Warrant [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Aggregate intrinsic value of options outstanding |
$ 0
|
|
|
Intrinsic value of warrants exercised |
|
$ 300,000
|
|
Warrants exercisable |
20,000
|
|
|
Warrants to purchase a common stock |
465,000
|
|
|
Stock Options [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Aggregate intrinsic value of options outstanding |
$ 100,000
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Unrecognized stock-based compensation |
$ 11,500,000
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term |
1 year 10 months 24 days
|
|
|
2015 Long Term Incentive Plan [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of common shares availalble for issuance |
4,361,861
|
|
12,000,000
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|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Tax Disclosure [Abstract] |
|
|
|
|
Income tax expense (benefit) |
$ 2,113,581
|
$ 2,114,638
|
$ 6,611,712
|
$ 1,470,058
|
Effective income tax rate reconciliation, percent |
26.10%
|
|
24.20%
|
|
Effective income tax rate reconciliation, percent |
|
|
21.00%
|
|
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Schedule of Maturities on Company Lease Liabilities (Details) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] |
|
|
2023 (remainder) |
$ 233,826
|
|
2024 |
966,451
|
|
2025 |
987,252
|
|
2026 |
682,806
|
|
Thereafter |
542,512
|
|
Total lease payments |
3,412,847
|
|
Less: imputed interest |
367,938
|
|
Present value of operating lease liabilities |
3,044,909
|
|
Less: current portion |
794,516
|
$ 297,209
|
Long-term portion |
$ 2,250,393
|
$ 50,708
|
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Co Diagnostics (NASDAQ:CODX)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Co Diagnostics (NASDAQ:CODX)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024