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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): March 27, 2025
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 March 27, 2025, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its year ended December 31, 2024. 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 March 27, 2025 | |
| 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: March 27, 2025 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: |
Chief Financial Officer (Principal Financial and Accounting Officer) |
|
Exhibit 99.1
Co-Diagnostics, Inc. Reports Full Year 2024 Financial Results
SALT LAKE CITY, March 27, 2025— 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 fourth quarter and full year ended December 31, 2024.
Full Year 2024 Financial Results:
| ● | Revenue of $3.9 million, which declined from $6.8 million during the prior year primarily due to higher Grant revenue in 2023. Grant revenue totaled $3.1 million while product revenue totaled $0.8 million | |
| ● | Operating expenses of $43.0 million decreased by 5.2% from the prior year due to higher expenses in 2023 related to platform development and regulatory submission preparation | |
| ● | Operating loss of $40.1 million compared to operating loss of $42.7 million in 2023 | |
| ● | Net loss of $37.6 million, compared to net loss of $35.3 million in the prior year, representing a loss of $1.24 per fully diluted share, compared to a loss of $1.20 per fully diluted share in the prior year | |
| ● | Adjusted EBITDA loss of $33.5 million | |
| ● | Cash, cash equivalents, and marketable securities of $29.7 million as of December 31, 2024 |
Full Year 2024 and Recent Business Highlights:
|
● |
Inaugurated CoSara Diagnostics Pvt. Ltd.’s oligonucleotide synthesis facility in India to manufacture the Company’s patented Co-Primers® chemistry |
|
● |
Attended a number of trade shows and expos throughout 2024, including UHCA/UCAL Fall Convention & Expo, Medlab Africa in Cape Town, and MEDICA Trade Fair in Germany | |
|
● |
Inaugurated a new manufacturing facility in South Salt Lake to manufacture our patented Co-Primers oligonucleotides, the Co-Dx™ PCR Pro™ instrument, and test cups for the new Co-Dx PCR platform | |
|
● |
Advanced regulatory strategy through completion of an initial 510(k) application to the U.S. Food and Drug Administration (FDA) for the Co-Dx™ PCR Pro™ Platform, which has subsequently been withdrawn with the intention of submitting an enhanced version of the test and instrument for 510(k) clearance |
“We are pleased by the progress of our pipeline development in 2024,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “We recently announced our decision to withdraw our 510(k) application for the Co-Dx PCR Pro and Co-Dx PCR COVID-19 test from the FDA, as we now prepare to gather updated clinical data in support of a new submission for an enhanced version of the test and instrument. We firmly believe that this decision will allow us to offer an even better test upon our initial launch and streamline the associated operational and manufacturing processes, which will be leveraged for future commercialization plans across our development pipeline. Elsewhere, we have made great progress on our tuberculosis test and anticipate clinical evaluations for this indication, as well as for the HPV multiplex and upper respiratory multiplex tests, all to commence later this year. We remain well positioned to execute our development and regulatory goals in 2025 and strongly believe in the potential of the platform, our people, and the company to make a positive impact on the state of global health.”
“We are pleased with how our progress in 2024 has moved us closer to commercializing the new platform, and are now actively focused on achieving our 2025 goals. As we advance our diagnostic test pipeline, we are committed to generating operational efficiencies to help offset development costs. We look forward to updating you on our further progress throughout the year,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer.
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 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 yet 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 identify 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, change in fair value of contingent consideration, and realized gain on investments. 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 (i) that our decision to withdraw our 510(k) application for the PCR Pro and associated COVID-19 test from the FDA and gather updated clinical will allow us to offer an even better test upon our initial launch and streamline the associated operational and manufacturing processes, and (ii) that we anticipate clinical evaluations for our tuberculosis test, as well as for the HPV multiplex and upper respiratory multiplex tests to commence later 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 27, 2025, 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
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 2,936,544 | $ | 14,916,878 | ||||
| Marketable investment securities | 26,811,098 | 43,631,510 | ||||||
| Accounts receivable, net | 132,570 | 303,926 | ||||||
| Inventory, net | 1,072,724 | 1,664,725 | ||||||
| Income taxes receivable | - | 26,955 | ||||||
| Prepaid expenses and other current assets | 1,338,762 | 1,597,114 | ||||||
| Total current assets | 32,291,698 | 62,141,108 | ||||||
| Property and equipment, net | 2,761,280 | 3,035,729 | ||||||
| Operating lease right-of-use asset | 2,114,876 | 2,966,774 | ||||||
| Intangible assets, net | 26,101,000 | 26,403,667 | ||||||
| Investment in joint venture | 731,065 | 773,382 | ||||||
| Total assets | $ | 63,999,919 | $ | 95,320,660 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,294,254 | $ | 1,482,109 | ||||
| Accrued expenses | 2,562,169 | 2,172,959 | ||||||
| Operating lease liability, current | 915,619 | 838,387 | ||||||
| Contingent consideration liabilities, current | 502,819 | 891,666 | ||||||
| Deferred revenue | 40,857 | 362,449 | ||||||
| Total current liabilities | 7,315,718 | 5,747,570 | ||||||
| Long-term liabilities | ||||||||
| Income taxes payable | 713,643 | 659,186 | ||||||
| Operating lease liability | 1,236,560 | 2,152,180 | ||||||
| Contingent consideration liabilities | 422,080 | 748,109 | ||||||
| Total long-term liabilities | 2,372,283 | 3,559,475 | ||||||
| Total liabilities | 9,688,001 | 9,307,045 | ||||||
| Commitments and contingencies (Note 12) | ||||||||
| Stockholders’ equity | ||||||||
| Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023 | 37,902 | 36,108 | ||||||
| Treasury stock, at cost; 4,848,678 shares held as of December 31, 2024 and December 31, 2023, respectively | (15,575,795 | ) | (15,575,795 | ) | ||||
| Additional paid-in capital | 102,472,210 | 96,808,436 | ||||||
| Accumulated other comprehensive income | 418,443 | 146,700 | ||||||
| Accumulated earnings (deficit) | (33,040,842 | ) | 4,598,166 | |||||
| Total stockholders’ equity | 54,311,918 | 86,013,615 | ||||||
| Total liabilities and stockholders’ equity | $ | 63,999,919 | $ | 95,320,660 | ||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Years Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Product revenue | $ | 770,048 | $ | 991,473 | ||||
| Grant revenue | 3,145,112 | 5,820,565 | ||||||
| Total revenue | 3,915,160 | 6,812,038 | ||||||
| Cost of revenue | 999,124 | 4,184,949 | ||||||
| Gross profit | 2,916,036 | 2,627,089 | ||||||
| Operating expenses | ||||||||
| Sales and marketing | 4,483,339 | 6,860,815 | ||||||
| General and administrative | 16,157,152 | 14,279,441 | ||||||
| Research and development | 20,979,589 | 22,962,593 | ||||||
| Depreciation and amortization | 1,377,266 | 1,230,474 | ||||||
| Total operating expenses | 42,997,346 | 45,333,323 | ||||||
| Loss from operations | (40,081,310 | ) | (42,706,234 | ) | ||||
| Other income, net | ||||||||
| Interest income, net | 1,091,825 | 1,161,913 | ||||||
| Realized gain on investments | 870,745 | 2,243,059 | ||||||
| Gain (loss) on disposition of assets | 8,291 | (2,578 | ) | |||||
| Gain on remeasurement of acquisition contingencies | 714,876 | 1,092,581 | ||||||
| Gain (loss) on equity method investment in joint venture | (186,067 | ) | 100,703 | |||||
| Total other income, net | 2,499,670 | 4,595,678 | ||||||
| Loss before income taxes | (37,581,640 | ) | (38,110,556 | ) | ||||
| Income tax provision (benefit) | 57,368 | (2,777,691 | ) | |||||
| Net loss | $ | (37,639,008 | ) | $ | (35,332,865 | ) | ||
| Other comprehensive loss | ||||||||
| Change in net unrealized gains on marketable securities, net of tax | 271,743 | (146,440 | ) | |||||
| Total other comprehensive income (loss) | $ | 271,743 | $ | (146,440 | ) | |||
| Comprehensive loss | $ | (37,367,265 | ) | $ | (35,479,305 | ) | ||
| Loss per common share: | ||||||||
| Basic and Diluted | $ | (1.24 | ) | $ | (1.20 | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and Diluted | 30,335,350 | 29,346,599 | ||||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
GAAP AND NON-GAAP MEASURES
Reconciliation of net loss to adjusted EBITDA:
| Years Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Net loss | $ | (37,639,008 | ) | $ | (35,332,865 | ) | ||
| Interest income, net | (1,091,825 | ) | (1,161,913 | ) | ||||
| Realized gain on investments | (870,745 | ) | (2,243,059 | ) | ||||
| Depreciation and amortization | 1,377,266 | 1,230,474 | ||||||
| (Gain) loss on disposition of assets | (8,291 | ) | 2,578 | |||||
| Change in fair value of contingent consideration | (714,876 | ) | (1,092,581 | ) | ||||
| Stock-based compensation expense | 5,434,904 | 8,336,856 | ||||||
| Income tax provision (benefit) | 57,368 | (2,777,691 | ) | |||||
| Adjusted EBITDA | $ | (33,455,207 | ) | $ | (33,038,201 | ) | ||