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Co-Diagnostics, Inc. Reports Third Quarter 2023 Financial Results

Receives grant award from the Bill & Melinda Gates Foundation in the amount of $9.0M for the development of tuberculosis test on Co-Dx™ PCR platform.

SALT LAKE CITY, Nov. 9, 2023 /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, 2023.

(PRNewsfoto/Co-Diagnostics)
(PRNewsfoto/Co-Diagnostics)

Third Quarter 2023 Financial Results:

  • Revenue of $2.5 million, down from $5.1 million during the prior year primarily due to the anticipated decline in global demand for COVID-19 tests. Grant revenue totaled $2.3 million while product revenue totaled $0.1 million

  • Operating expenses of $11.1 million increased by 2.5% from the prior year same period due to investments in our Co-Dx™ PCR platform*

  • Operating loss of $8.9 million compared to operating loss of $6.5 million a year ago

  • Net loss of $6.0 million, compared to net loss of $1.4 million in the prior year second quarter, representing a loss of $0.20 per fully diluted share, compared to a loss of $0.04 per fully diluted share in the prior year period

  • Adjusted EBITDA loss of $6.5 million

  • Repurchased 149,041 shares of common stock at an average price of $1.12 per share for an aggregate purchase price of approximately $0.2 million

  • Cash, cash equivalents, and marketable securities of $63.4 million as of September 30, 2023

2023 Recent Business Highlights:

  • Continue to expect EUA submission to the FDA for our Co-Dx PCR Pro™ platform and COVID-19 assay before the end of 2023

  • Received additional grant funding from the Bill & Melinda Gates Foundation in the amount of $9.0M, to be applied towards regulatory and clinical validation activities for our tuberculosis test and additional manufacturing and platform development

  • Appointed Ivory Chang as Chief Regulatory Affairs Officer, who previously worked at multiple large, renowned diagnostic companies, and brings many years of experience in in-vitro diagnostic product and point-of-care regulatory submissions to Co-Diagnostics

  • Participated in several investor conferences, trade shows, and industry events to share Co-Diagnostics' vision for increasing accessibility of PCR diagnostics worldwide, the Company's unique value proposition, and updates on its new platform

Dwight Egan, Co-Diagnostics' Chief Executive Officer, said, "We are pleased to report $2.3 million in grant revenue, bringing our total revenue to approximately $2.5 million in the third quarter of 2023. We remain excited for the future of Co-Diagnostics and believe that the additional grant funding we recently received further validates the disruptive nature of our platform. The Company expects to finalize an EUA submission to the FDA for the COVID-19 test on our Co-Dx PCR platform by year-end. We anticipate our new platform will serve as the foundation for Co-Diagnostics' future development initiatives and believe that our patented Co-Primers™ technology allows for reliable, affordable high-quality test results and look forward to delivering our unique platform to the market."

"We remain committed on our strategy and mission and continue to progress in the development of other test indications beyond Covid-19 for the new platform: TB, multiplex respiratory, and HPV," said Brian Brown, Co-Diagnostics' Chief Financial Officer. "We are pleased with our progress this year and believe in the potential for the new platform to have a transformative effect on diagnostics worldwide."

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 at-home and point-of-care 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 currently available for sale.

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, stock-based compensation, 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 completion of development and FDA submission for approval of the Co-Dx PCR platform by end of 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 16, 2023, 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, 2023



December 31, 2022


Assets









Current assets









Cash and cash equivalents


$

10,239,898



$

22,973,803


Marketable investment securities



53,188,999




58,289,066


Accounts receivable, net



806,704




3,453,723


Inventory, net



4,520,430




5,310,473


Income taxes receivable



1,245,854




1,870,419


Prepaid expenses and other current assets



1,290,146




761,187


Note receivable



18,750




75,000


Total current assets



71,310,781




92,733,671


Property and equipment, net



2,808,339




2,539,483


Deferred tax asset



4,272,002




-


Operating lease right-of-use asset



3,032,337




372,115


Intangible assets, net



26,479,333




26,768,333


Investment in joint venture



778,943




672,679


Total assets


$

108,681,735



$

123,086,281


Liabilities and stockholders' equity









Current liabilities









Accounts payable


$

1,416,435



$

952,296


Accrued expenses, current



1,826,639




934,447


Operating lease liability, current



794,516




297,209


Contingent consideration liabilities, current



710,651




1,689,471


Deferred revenue



349,499




-


Total current liabilities



5,097,740




3,873,423


Long-term liabilities









Income taxes payable



1,359,725




1,181,284


Deferred tax liability



-




2,417,987


Operating lease liability



2,250,393




50,708


Contingent consideration liabilities



484,332




1,042,885


Total long-term liabilities



4,094,450




4,692,864


Total liabilities



9,192,190




8,566,287


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 September 30,
2023 and December 31, 2022, respectively



-




-


Common stock, $0.001 par value; 100,000,000 shares
authorized; 35,367,100 shares issued and 30,658,580 shares
outstanding as of September 30, 2023 and 34,754,265 shares
issued and 30,872,607 shares outstanding as of December 31, 2022



35,367




34,754


Treasury stock, at cost; 4,708,520 and 3,881,658 shares held as
of September 30, 2023 and December 31, 2022, respectively



(15,416,122)




(14,211,866)


Additional paid-in capital



94,983,030




88,472,935


Accumulated other comprehensive income



612,649




293,140


Accumulated earnings



19,274,621




39,931,031


Total stockholders' equity



99,489,545




114,519,994


Total liabilities and stockholders' equity


$

108,681,735



$

123,086,281


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)




Three Months Ended September 30,



Nine Months Ended September 30,




2023



2022



2023



2022


Product revenue


$

136,533



$

5,094,456



$

936,296



$

32,816,726


Grant revenue



2,320,565




-




2,320,565




-


Total revenue



2,457,098




5,094,456




3,256,861




32,816,726


Cost of revenue



255,772




767,936




1,217,108




4,965,319


Gross profit



2,201,326




4,326,520




2,039,753




27,851,407


Operating expenses

















Sales and marketing



1,904,395




1,889,907




5,343,692




6,014,280


General and administrative



3,147,753




3,622,273




9,875,613




9,012,888


Research and development



5,788,789




5,037,461




16,783,892




12,698,632


Depreciation and amortization



296,340




312,494




917,596




984,100


Total operating expenses



11,137,277




10,862,135




32,920,793




28,709,900


(Loss) from operations



(8,935,951)




(6,535,615)




(30,881,040)




(858,493)


Other income, net

















Interest income



322,877




298,184




717,141




371,248


Realized gain on investments



425,446




-




1,254,718




-


Gain (loss) on disposition of assets



(2,578)




4,044




(2,578)




(138,117)


Gain on remeasurement of acquisition contingencies



140,296




2,886,734




1,537,373




7,079,446


Gain (loss) on equity method investment in joint venture



(45,865)




(129,047)




106,264




(256,911)


Total other income, net



840,176




3,059,915




3,612,918




7,055,666


Income (loss) before income taxes



(8,095,775)




(3,475,700)




(27,268,122)




6,197,173


Income tax (benefit)



(2,113,581)




(2,114,638)




(6,611,712)




(1,470,058)


Net income (loss)


$

(5,982,194)



$

(1,361,062)



$

(20,656,410)



$

7,667,231


Other comprehensive income (loss)

















Change in net unrealized gains on
marketable securities, net of tax


$

33,522



$

-



$

319,509



$

-


Total other comprehensive income


$

33,522



$

-



$

319,509



$

-


Comprehensive income (loss)


$

(5,948,672)



$

(1,361,062)



$

(20,336,901)



$

7,667,231



















Earnings (loss) per common share:

















Basic


$

(0.20)



$

(0.04)



$

(0.70)



$

0.24


Diluted


$

(0.20)



$

(0.04)



$

(0.70)



$

0.23


Weighted average shares outstanding:

















Basic



29,361,300




31,321,368




29,306,572




32,109,213


Diluted



29,361,300




31,321,368




29,306,572




33,002,539


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
GAAP AND NON-GAAP MEASURES
(Unaudited) 


Reconciliation of net income to adjusted EBITDA:



















Three Months Ended September 30,



Nine Months Ended September 30,




2023



2022



2023



2022


Net income (loss)


$

(5,982,194)



$

(1,361,062)



$

(20,656,410)



$

7,667,231


Interest income



(322,877)




(298,184)




(717,141)




(371,248)


Realized gain on investments



(425,446)




-




(1,254,718)




-


Depreciation and amortization



296,340




312,494




917,596




984,100


Transaction costs



-




13,038




310




139,209


Change in fair value of contingent consideration



(140,296)




(2,886,734)




(1,537,373)




(7,079,446)


Stock-based compensation expense



2,172,165




2,230,434




6,510,708




5,138,815


Income tax provision



(2,113,581)




(2,114,638)




(6,611,712)




(1,470,058)


Adjusted EBITDA


$

(6,515,889)



$

(4,104,652)



$

(23,348,740)



$

5,008,603


 

Cision
Cision

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SOURCE Co-Diagnostics

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