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Co-Diagnostics Inc

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

SALT LAKE CITY , Nov. 7, 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 September 30, 2024.

Third Quarter 2024 Financial Results:

  • Revenue of $0.6 million, which declined from $2.5 million during the prior year primarily due to timing of grant revenue recognition. Grant revenue totaled $0.4 million while product revenue totaled $0.2 million
  • Operating expenses of $10.6 million decreased by 5.0% from the prior year due to higher expenses in 2023 related to platform development and regulatory submission preparation
  • Operating loss of $10.2 million compared to operating loss of $8.9 million in 2023
  • Net 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, compared to a loss of $0.20 per fully diluted share in the prior year
  • Adjusted EBITDA loss of $8.8 million
  • Cash, cash equivalents, and marketable securities of $37.7 million as of September 30, 2024

Third Quarter and Recent 2024 Business Highlights:

  • Completed in silico analysis of the Co-Dx™ Logix Smart® Mpox 2-Gene RUO test to evaluate sensitivity for clade 1b mpox, which showed that the test should retain full reactivity against newer strains
  • Announced expansion of vector control business line to customers across 15 states
  • Attended and participated in ADLM 2024 in Chicago to discuss the role of the Co-Dx PCR Pro™ Platform* in closing the global diagnostics gap for many indications, including tuberculosis (TB)
  • Presented and hosted a booth at the 16th Next Generation Dx Summit in Washington, D.C., to discuss the future of accessible diagnostics on the Co-Dx PCR Pro Platform*
  • Oligonucleotide (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.  

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 advancement of all tests in our pipeline towards completion, regulatory submission and commercialization and our belief 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. 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)




September 30, 2024



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


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS 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

GAAP AND NON-GAAP MEASURES

(Unaudited)


Reconciliation of 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)


 

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SOURCE Co-Diagnostics