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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): August 8, 2024
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 August 8, 2024, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended June 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.
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 August 8, 2024 | |
| 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: August 8, 2024 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: | Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
Exhibit 99.1
Co-Diagnostics, Inc. Reports Second Quarter 2024 Financial Results
SALT LAKE CITY, August 8, 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 June 30, 2024.
Second Quarter 2024 Financial Results:
| ● | Revenue of $2.7 million, up from $0.2 million during the prior year primarily due to the achievement of certain milestones under various grant agreements the company was awarded | |
| ● | Operating expenses of $10.1 million decreased by 13.7% from the prior year due to lower stock-based compensation expense, bad debt expense, and expenses related to clinical trials for the Co-Dx PCR platform | |
| ● | Operating loss of $7.7 million compared to operating loss of $12.0 million in 2023 | |
| ● | Net loss of $7.6 million, compared to net loss of $8.9 million in the prior year, representing a loss of $0.25 per fully diluted share, compared to a loss of $0.31 per fully diluted share in the prior year | |
| ● | Adjusted EBITDA loss of $5.9 million compared to $9.6 million in the prior year | |
| ● | Cash, cash equivalents, and marketable securities of $44.9 million as of June 30, 2024 |
Second Quarter and Recent 2024 Business Highlights:
| ● | Submitted first 510(k) application to the U.S. Food and Drug Administration (FDA) for the Co-Dx™ PCR Pro™ Platform, which includes the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 test for over-the-counter (OTC) use | |
| ● | 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 | |
| ● | Expanded Co-Dx vector control technology to a 15th U.S. state, Nevada, which includes Vector Smart® PCR tests in environmental surveillance of mosquito pools for mosquito-borne illnesses | |
| ● | Attended and participated in the FIME 2024 trade show in Miami Beach, Florida, which included exhibitors from 116 countries and over 15,000 professional attendees, to display the new Co-Dx PCR platform |
“We are very pleased by the progress Co-Diagnostics has made so far this year,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “Our 510(k) application for our new instrument and COVID-19 test kit, which we submitted to the FDA for over-the-counter (OTC) use, is a significant accomplishment. Medical devices cleared for OTC use are automatically categorized as CLIA-waived, making them also suitable for use at the point-of-care as well. We believe this will help to further expand the market and value of the new platform while we prepare to pursue clearance from the FDA for the Co-Dx PCR COVID-19 test on the new instrument specifically for point-of-care use. We look forward to providing you with updates as they come and continue to work hard to further the development of TB, multiplex respiratory, and HPV tests throughout the year.”
“We truly believe that we are one-step closer to delivering the most low-cost, easy to use, and highly accessible diagnostics point of care platform. We also look forward to beginning clinical evaluations for our multiplex test later this 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. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.
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, realized gains on investments, stock-based compensation, change in fair value of contingent consideration, gain or loss on disposition of assets, 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 our belief that, because medical devices cleared for OTC use are automatically categorized as CLIA-waived, making them also suitable for use at the point-of-care as well, such clearance will help to further expand the market and value of the new platform while we prepare to pursue clearance from the FDA for the Co-Dx PCR COVID-19 test on the new instrument specifically for point-of-care use and our anticipation that we will begin clinical evaluations for our multiplex test 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 14, 2024, 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)
| June 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 13,858,866 | $ | 14,916,878 | ||||
| Marketable investment securities | 31,020,811 | 43,631,510 | ||||||
| Accounts receivable, net | 551,504 | 303,926 | ||||||
| Inventory, net | 1,463,960 | 1,664,725 | ||||||
| Income taxes receivable | - | 26,955 | ||||||
| Prepaid expenses and other current assets | 1,324,098 | 1,597,114 | ||||||
| Total current assets | 48,219,239 | 62,141,108 | ||||||
| Property and equipment, net | 3,054,487 | 3,035,729 | ||||||
| Operating lease right-of-use asset | 2,547,485 | 2,966,774 | ||||||
| Intangible assets, net | 26,252,333 | 26,403,667 | ||||||
| Investment in joint venture | 627,924 | 773,382 | ||||||
| Total assets | $ | 80,701,468 | $ | 95,320,660 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,863,499 | $ | 1,482,109 | ||||
| Accrued expenses | 1,504,750 | 2,172,959 | ||||||
| Operating lease liability, current | 878,174 | 838,387 | ||||||
| Contingent consideration liabilities, current | 838,032 | 891,666 | ||||||
| Deferred revenue | 220,930 | 362,449 | ||||||
| Total current liabilities | 5,305,385 | 5,747,570 | ||||||
| Long-term liabilities | ||||||||
| Income taxes payable | 699,113 | 659,186 | ||||||
| Operating lease liability | 1,703,717 | 2,152,180 | ||||||
| Contingent consideration liabilities | 595,599 | 748,109 | ||||||
| Total long-term liabilities | 2,998,429 | 3,559,475 | ||||||
| Total liabilities | 8,303,814 | 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; 36,759,680 shares issued and 31,911,002 shares outstanding as of June 30, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023 | 36,760 | 36,108 | ||||||
| Treasury stock, at cost; 4,848,678 shares held as of June 30, 2024 and December 31, 2023, respectively | (15,575,795 | ) | (15,575,795 | ) | ||||
| Additional paid-in capital | 99,878,676 | 96,808,436 | ||||||
| Accumulated other comprehensive income | 371,208 | 146,700 | ||||||
| Accumulated earnings (deficit) | (12,313,195 | ) | 4,598,166 | |||||
| Total stockholders’ equity | 72,397,654 | 86,013,615 | ||||||
| Total liabilities and stockholders’ equity | $ | 80,701,468 | $ | 95,320,660 | ||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| Three Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Product revenue | $ | 161,102 | $ | 197,806 | ||||
| Grant revenue | 2,495,738 | - | ||||||
| Total revenue | 2,656,840 | 197,806 | ||||||
| Cost of revenue | 212,148 | 459,095 | ||||||
| Gross profit | 2,444,692 | (261,289 | ) | |||||
| Operating expenses | ||||||||
| Sales and marketing | 1,041,243 | 1,732,966 | ||||||
| General and administrative | 3,132,385 | 3,713,895 | ||||||
| Research and development | 5,612,691 | 5,981,043 | ||||||
| Depreciation and amortization | 338,335 | 305,246 | ||||||
| Total operating expenses | 10,124,654 | 11,733,150 | ||||||
| Loss from operations | (7,679,962 | ) | (11,994,439 | ) | ||||
| Other income, net | ||||||||
| Interest income | 342,188 | 191,892 | ||||||
| Realized gain on investments | 74,165 | 411,190 | ||||||
| Gain on disposition of assets | 3,500 | - | ||||||
| Gain (loss) on remeasurement of acquisition contingencies | (244,116 | ) | 359,405 | |||||
| Gain (loss) on equity method investment in joint venture | (74,503 | ) | (125,193 | ) | ||||
| Total other income, net | 101,234 | 837,294 | ||||||
| Loss before income taxes | (7,578,728 | ) | (11,157,145 | ) | ||||
| Income tax provision (benefit) | 20,590 | (2,238,320 | ) | |||||
| Net loss | $ | (7,599,318 | ) | $ | (8,918,825 | ) | ||
| Other comprehensive loss | ||||||||
| Change in net unrealized gains on marketable securities, net of tax | 144,653 | 107,366 | ||||||
| Total other comprehensive income | $ | 144,653 | $ | 107,366 | ||||
| Comprehensive loss | $ | (7,454,665 | ) | $ | (8,811,459 | ) | ||
| Loss per common share: | ||||||||
| Basic and Diluted | $ | (0.25 | ) | $ | (0.31 | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and Diluted | 30,124,696 | 29,088,159 | ||||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
GAAP AND NON-GAAP MEASURES
(Unaudited)
Reconciliation of net loss to adjusted EBITDA:
| Three Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Net loss | $ | (7,599,318 | ) | $ | (8,918,825 | ) | ||
| Interest income | (342,188 | ) | (191,892 | ) | ||||
| Realized gain on investments | (74,165 | ) | (411,190 | ) | ||||
| Depreciation and amortization | 338,335 | 305,246 | ||||||
| Gain on disposition of assets | (3,500 | ) | - | |||||
| Change in fair value of contingent consideration | 244,116 | (359,405 | ) | |||||
| Stock-based compensation expense | 1,499,658 | 2,169,801 | ||||||
| Income tax provision (benefit) | 20,590 | (2,238,320 | ) | |||||
| Adjusted EBITDA | $ | (5,916,472 | ) | $ | (9,644,585 | ) | ||