エドガーで原本を確認する
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 9, 2023
CO-DIAGNOSTICS, INC.
(Exact name of small business issuer as specified in its charter)
| Utah | 1-38148 | 46-2609363 | ||
| (State or other jurisdiction of | (Commission | (IRS Employer | ||
| incorporation or organization) | File Number) | Identification Number) |
2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address of principal executive offices)
(801) 438-1036
(Issuer’s telephone number)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | CODX | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 9, 2023, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended September 30, 2023. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Form 8-K.
The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.
Item 7.01. Regulation FD. Disclosure.
The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No.: | Description: | |
| 99.1 | Press Release, dated November 9, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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, hereunto duly authorized.
| CO-DIAGNOSTICS, INC. | ||
| Date: November 9, 2023 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: |
Chief Financial Officer (Principal Financial and Accounting Officer) |
|
Exhibit 99.1
Co-Diagnostics, Inc. Reports Third Quarter 2023 Financial Results
Receives grant award from the Bill & Melinda Gates Foundation in the amount of $9.0M for the development of tuberculosis test on Co-Dx™ PCR platform.
SALT LAKE CITY, November 9, 2023— Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended September 30, 2023.
Third Quarter 2023 Financial Results:
| ● | Revenue of $2.5 million, down from $5.1 million during the prior year primarily due to the anticipated decline in global demand for COVID-19 tests. Grant revenue totaled $2.3 million while product revenue totaled $0.1 million | |
| ● | Operating expenses of $11.1 million increased by 2.5% from the prior year same period due to investments in our Co-Dx™ PCR platform* | |
| ● | Operating loss of $8.9 million compared to operating loss of $6.5 million a year ago | |
| ● | Net loss of $6.0 million, compared to net loss of $1.4 million in the prior year second quarter, representing a loss of $0.20 per fully diluted share, compared to a loss of $0.04 per fully diluted share in the prior year period | |
| ● | Adjusted EBITDA loss of $6.5 million | |
| ● | Repurchased 149,041 shares of common stock at an average price of $1.12 per share for an aggregate purchase price of approximately $0.2 million | |
| ● | Cash, cash equivalents, and marketable securities of $63.4 million as of September 30, 2023 | |
|
2023 Recent Business Highlights:
|
||
| ● | Continue to expect EUA submission to the FDA for our Co-Dx PCR Pro™ platform and COVID-19 assay before the end of 2023 | |
| ● | Received additional grant funding from the Bill & Melinda Gates Foundation in the amount of $9.0M, to be applied towards regulatory and clinical validation activities for our tuberculosis test and additional manufacturing and platform development | |
| ● | Appointed Ivory Chang as Chief Regulatory Affairs Officer, who previously worked at multiple large, renowned diagnostic companies, and brings many years of experience in in-vitro diagnostic product and point-of-care regulatory submissions to Co-Diagnostics | |
| ● | Participated in several investor conferences, trade shows, and industry events to share Co-Diagnostics’ vision for increasing accessibility of PCR diagnostics worldwide, the Company’s unique value proposition, and updates on its new platform | |
Dwight Egan, Co-Diagnostics’ Chief Executive Officer, said, “We are pleased to report $2.3 million in grant revenue, bringing our total revenue to approximately $2.5 million in the third quarter of 2023. We remain excited for the future of Co-Diagnostics and believe that the additional grant funding we recently received further validates the disruptive nature of our platform. The Company expects to finalize an EUA submission to the FDA for the COVID-19 test on our Co-Dx PCR platform by year-end. We anticipate our new platform will serve as the foundation for Co-Diagnostics’ future development initiatives and believe that our patented Co-Primers™ technology allows for reliable, affordable high-quality test results and look forward to delivering our unique platform to the market.”
“We remain committed on our strategy and mission and continue to progress in the development of other test indications beyond Covid-19 for the new platform: TB, multiplex respiratory, and HPV,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer. “We are pleased with our progress this year and believe in the potential for the new platform to have a transformative effect on diagnostics worldwide.”
Conference Call and Webcast
Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:
Webcast: ir.codiagnostics.com on the Events & Webcasts page
Conference Call: 844-481-2661 (domestic) or 412-317-0652 (international)
The call will be recorded and later made available on the Company’s website: https://codiagnostics.com.
*The Co-Dx PCR at-home and point-of-care platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not currently available for sale.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.
Non-GAAP Financial Measures:
This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, and one-time transaction related costs. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’s management uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.
Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.
Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,” “expects,” “estimates,” “intends,” “may,” “plans,” “will” and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements regarding completion of development and FDA submission for approval of the Co-Dx PCR platform by end of this year. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 16, 2023, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
Investor Relations Contact:
Andrew Benson
Head of Investor Relations
+1 801-438-1036
investors@codiagnostics.com
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
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 | ||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
| 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 (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 | ||||||||||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
GAAP AND NON-GAAP MEASURES
(Unaudited)
| Reconciliation of net income to adjusted EBITDA: | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net income (loss) | $ | (5,982,194 | ) | $ | (1,361,062 | ) | $ | (20,656,410 | ) | $ | 7,667,231 | |||||
| Interest income | (322,877 | ) | (298,184 | ) | (717,141 | ) | (371,248 | ) | ||||||||
| Realized gain on investments | (425,446 | ) | - | (1,254,718 | ) | - | ||||||||||
| Depreciation and amortization | 296,340 | 312,494 | 917,596 | 984,100 | ||||||||||||
| Transaction costs | - | 13,038 | 310 | 139,209 | ||||||||||||
| Change in fair value of contingent consideration | (140,296 | ) | (2,886,734 | ) | (1,537,373 | ) | (7,079,446 | ) | ||||||||
| Stock-based compensation expense | 2,172,165 | 2,230,434 | 6,510,708 | 5,138,815 | ||||||||||||
| Income tax provision | (2,113,581 | ) | (2,114,638 | ) | (6,611,712 | ) | (1,470,058 | ) | ||||||||
| Adjusted EBITDA | $ | (6,515,889 | ) | $ | (4,104,652 | ) | $ | (23,348,740 | ) | $ | 5,008,603 | |||||