Co-Diagnostics, Inc. Reports Second Quarter 2024 Financial Results

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 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.

 

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)

 

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SOURCE Co-Diagnostics

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