SALT LAKE CITY, August 8, 2024 /PRNewswire/ -- 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 15^th 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.