8-K
Co-Diagnostics, Inc. (CODX)
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 7, 2024
CO-DIAGNOSTICS,
INC.
(Exact name of small business issuer as specified in its charter)
| Utah | 1-38148 | 46-2609363 |
|---|---|---|
| (State<br> or other jurisdiction of | (Commission | (IRS<br> Employer |
| incorporation<br> or organization) | File<br> Number) | Identification<br> Number) |
2401S. 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.001 per share | CODX | The<br> 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. ☐
Item2.02. Results of Operations and Financial Condition.
On November 7, 2024, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended September 30, 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.
Item7.01. Regulation FD. Disclosure.
The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No.: | Description: |
|---|---|
| 99.1 | Press Release, dated November 7, 2024 |
| 104 | Cover<br> 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:<br> November 7, 2024 | By: | /s/ Brian Brown |
| Name: | Brian<br> Brown | |
| Title: | Chief<br> Financial Officer | |
| (Principal<br> Financial and Accounting Officer) |
Exhibit 99.1
Co-Diagnostics,Inc. Reports Third Quarter 2024 Financial Results
SALTLAKE CITY, November 7, 2024— 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, 2024.
ThirdQuarter 2024 Financial Results:
| ● | Revenue<br> of $0.6 million, which declined from $2.5 million during the prior year primarily due to timing of grant revenue recognition.<br> Grant revenue totaled $0.4 million while product revenue totaled $0.2 million |
|---|---|
| ● | Operating<br> expenses of $10.6 million decreased by 5.0% from the prior year due to higher expenses in 2023 related to platform development and<br> regulatory submission preparation |
| ● | Operating<br> loss of $10.2 million compared to operating loss of $8.9 million in 2023 |
| ● | Net<br> loss of $9.7 million, compared to net loss of $6.0 million in the prior year, representing a loss of $0.32 per fully diluted share,<br> compared to a loss of $0.20 per fully diluted share in the prior year |
| ● | Adjusted<br> EBITDA loss of $8.8 million |
| ● | Cash,<br> cash equivalents, and marketable securities of $37.7 million as of September 30, 2024 |
ThirdQuarter and Recent 2024 Business Highlights:
| ● | Completed<br> in silico analysis of the Co-Dx™ Logix Smart® Mpox 2-Gene RUO test to evaluate sensitivity for clade 1b mpox, which showed<br> that the test should retain full reactivity against newer strains |
|---|---|
| ● | Announced<br> expansion of vector control business line to customers across 15 states |
| ● | Attended<br> and participated in ADLM 2024 in Chicago to discuss the role of the Co-Dx PCR Pro™ Platform* in closing the global diagnostics<br> gap for many indications, including tuberculosis (TB) |
| ● | Presented<br> and hosted a booth at the 16^th^ Next Generation Dx Summit in Washington, D.C., to discuss the future of accessible diagnostics<br> on the Co-Dx PCR Pro Platform* |
| ● | Oligonucleotide<br> (Co-Primers) manufacturing facility in India preparing for inauguration in early December 2024 |
“We are excited by the progress that Co-Diagnostics has made on the development of our pipeline this year,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “We have maintained an active dialogue with the FDA throughout their substantive review of our 510(k) application, and continue to advance all tests in our pipeline towards completion, regulatory submission and commercialization. At Co-Diagnostics, we firmly believe that our COVID-19, tuberculosis, multiplex respiratory, and HPV multiplex tests on the Co-Dx PCR platform have the potential to increase access to state-of-the-art PCR diagnostics and to improve the quality of health care around the world. Our team has been working hard to make our mission a reality, and I am excited to continue to drive our test developments forward throughout the remainder of the year and into next.”
“Co-Diagnostics has made significant progress on our tests, and look forward to providing you with regulatory and commercialization updates as they develop,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer.
ConferenceCall 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.
*TheCo-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by theFDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currentlyunder review by the FDA.
AboutCo-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-GAAPFinancial Measures:
Thispress release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, incometax (benefit) expense, net interest (income) expense, realized gains on investments, stock-based compensation, change in fairvalue of contingent consideration, gain or loss on disposition of assets, and one-time transaction related costs. The Company believesthat adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’smanagement uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and forbudgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to usein evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, manyof which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metricsused by management in its financial and operational decision-making.
Managementdoes not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. Theprincipal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recordedin the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financialmeasure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, butshould not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparableGAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliationand not to rely on any single financial measure to evaluate the Company’s business.
Forward-LookingStatements:
Thispress release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,”“expects,” “estimates,” “intends,” “may,” “plans,” “will” andsimilar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they existat the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release includestatements regarding our advancement of all tests in our pipeline towards completion, regulatory submission and commercialization andour belief that our COVID-19, tuberculosis, multiplex respiratory, and HPV multiplex tests on the Co-Dx PCR platform have the potentialto increase access to state-of-the-art PCR diagnostics and to improve the quality of health care around the world.Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materiallyfrom those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place unduereliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basisor at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Reporton Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Companydoes not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, exceptas may be required by applicable securities laws.
InvestorRelations Contact:
AndrewBenson
Head of Investor Relations
+1 801-438-1036
investors@codiagnostics.com
CO-DIAGNOSTICS,INC. AND SUBSIDIARIES
CONSOLIDATEDBALANCE SHEETS
(Unaudited)
| December 31, 2023 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets | |||||
| Cash and cash equivalents | 10,797,630 | $ | 14,916,878 | ||
| Marketable investment securities | 26,864,571 | 43,631,510 | |||
| Accounts receivable, net | 178,243 | 303,926 | |||
| Inventory, net | 1,266,016 | 1,664,725 | |||
| Income taxes receivable | - | 26,955 | |||
| Prepaid expenses and other current assets | 996,698 | 1,597,114 | |||
| Total current assets | 40,103,158 | 62,141,108 | |||
| Property and equipment, net | 2,984,112 | 3,035,729 | |||
| Operating lease right-of-use asset | 2,332,877 | 2,966,774 | |||
| Intangible assets, net | 26,176,667 | 26,403,667 | |||
| Investment in joint venture | 784,357 | 773,382 | |||
| Total assets | 72,381,171 | $ | 95,320,660 | ||
| Liabilities and stockholders’ equity | |||||
| Current liabilities | |||||
| Accounts payable | 2,176,426 | $ | 1,482,109 | ||
| Accrued expenses | 1,826,297 | 2,172,959 | |||
| Operating lease liability, current | 896,745 | 838,387 | |||
| Contingent consideration liabilities, current | 838,032 | 891,666 | |||
| Deferred revenue | 60,477 | 362,449 | |||
| Total current liabilities | 5,797,977 | 5,747,570 | |||
| Long-term liabilities | |||||
| Income taxes payable | 719,628 | 659,186 | |||
| Operating lease liability | 1,472,100 | 2,152,180 | |||
| Contingent consideration liabilities | 607,526 | 748,109 | |||
| Total long-term liabilities | 2,799,254 | 3,559,475 | |||
| Total liabilities | 8,597,231 | 9,307,045 | |||
| 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 June 30, 2024 and December 31, 2023, respectively | - | - | |||
| Common stock, 0.001 par value; 100,000,000 shares authorized; 36,778,430 shares issued and 31,929,752 shares outstanding as of September 30, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023 | 36,778 | 36,108 | |||
| Treasury stock, at cost; 4,848,678 shares held as of September 30, 2024 and December 31, 2023, respectively | (15,575,795 | ) | (15,575,795 | ) | |
| Additional paid-in capital | 100,924,241 | 96,808,436 | |||
| Accumulated other comprehensive income | 408,366 | 146,700 | |||
| Accumulated earnings (deficit) | (22,009,650 | ) | 4,598,166 | ||
| Total stockholders’ equity | 63,783,940 | 86,013,615 | |||
| Total liabilities and stockholders’ equity | 72,381,171 | $ | 95,320,660 |
All values are in US Dollars.
CO-DIAGNOSTICS,INC. AND SUBSIDIARIES
CONSOLIDATEDSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| Three Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| Product revenue | $ | 206,876 | $ | 136,533 | ||
| Grant revenue | 434,265 | 2,320,565 | ||||
| Total revenue | 641,141 | 2,457,098 | ||||
| Cost of revenue | 297,403 | 255,772 | ||||
| Gross profit | 343,738 | 2,201,326 | ||||
| Operating expenses | ||||||
| Sales and marketing | 1,059,745 | 1,904,395 | ||||
| General and administrative | 4,287,380 | 3,147,753 | ||||
| Research and development | 4,880,315 | 5,788,789 | ||||
| Depreciation and amortization | 351,235 | 296,340 | ||||
| Total operating expenses | 10,578,675 | 11,137,277 | ||||
| Loss from operations | (10,234,937 | ) | (8,935,951 | ) | ||
| Other income, net | ||||||
| Interest income | 263,335 | 322,877 | ||||
| Realized gain on investments | 293,067 | 425,446 | ||||
| Gain on disposition of assets | 3,513 | (2,578 | ) | |||
| Gain (loss) on remeasurement of acquisition contingencies | (11,927 | ) | 140,296 | |||
| Gain (loss) on equity method investment in joint venture | 12,683 | (45,865 | ) | |||
| Total other income, net | 560,671 | 840,176 | ||||
| Loss before income taxes | (9,674,266 | ) | (8,095,775 | ) | ||
| Income tax provision (benefit) | 22,189 | (2,113,581 | ) | |||
| Net loss | $ | (9,696,455 | ) | $ | (5,982,194 | ) |
| Other comprehensive loss | ||||||
| Change in net unrealized gains on marketable securities, net of tax | 37,158 | 33,522 | ||||
| Total other comprehensive income | $ | 37,158 | $ | 33,522 | ||
| Comprehensive loss | $ | (9,659,297 | ) | $ | (5,948,672 | ) |
| Loss per common share: | ||||||
| Basic and Diluted | $ | (0.32 | ) | $ | (0.20 | ) |
| Weighted average shares outstanding: | ||||||
| Basic and Diluted | 30,494,206 | 29,361,300 |
CO-DIAGNOSTICS,INC. AND SUBSIDIARIES
GAAPAND NON-GAAP MEASURES
(Unaudited)
Reconciliationof net loss to adjusted EBITDA:
| Three Months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| Net loss | $ | (9,696,455 | ) | $ | (5,982,194 | ) |
| Interest income | (263,335 | ) | (322,877 | ) | ||
| Realized gain on investments | (293,067 | ) | (425,446 | ) | ||
| Depreciation and amortization | 351,235 | 296,340 | ||||
| Gain on disposition of assets | (3,513 | ) | 2,578 | |||
| Stock-based compensation expense | 1,045,583 | 2,172,165 | ||||
| Income tax provision (benefit) | 22,189 | (2,113,581 | ) | |||
| Change in fair value of contingent consideration | 11,927 | (140,296 | ) | |||
| Adjusted EBITDA | $ | (8,825,436 | ) | $ | (6,513,311 | ) |