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Co-Diagnostics, Inc. Reports Full Year 2022 Financial Results

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Co-Diagnostics, Inc. (NASDAQ: CODX) reported a revenue of $34.2 million for the full year 2022, significantly down from $97.9 million in 2021, primarily due to reduced demand for Logix Smart™ COVID-19 tests. The company faced an operating loss of $27.0 million, compared to an operating income of $46.1 million the previous year. Net loss totaled $14.2 million, translating to a loss of $0.45 per diluted share. Despite these challenges, Co-Diagnostics initiated clinical evaluations for its Co-Dx PCR Home™ platform, signaling a shift towards at-home diagnostics. The company also repurchased 3.9 million shares for approximately $14.2 million.

Positive
  • Initiated clinical evaluations for Co-Dx PCR Home platform, expanding diagnostics potential.
  • Repurchased 3.9 million shares, thereby enhancing shareholder value.
  • Cash, cash equivalents, and marketable securities totaled $81.3 million as of December 31, 2022.
Negative
  • Revenue declined by 65% from the prior year due to lower COVID-19 testing demand.
  • Operating loss of $27.0 million, reflecting a significant downturn in profitability.
  • Net loss of $14.2 million, contrasting with the prior year's net income of $36.7 million.

Full-year Results Impacted by Lower Demand for COVID-19 Testing
Announced Initiation of Clinical Evaluations for Co-Dx PCR Home™ Platform

SALT LAKE CITY, March 16, 2023 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today financial results for the full year ended December 31, 2022.

Full Year 2022 Financial Results:

  • Revenue of $34.2 million, down from $97.9 million during the prior year primarily due to lower global demand for the Logix Smart™ COVID-19 tests
  • Gross profit of $28.7 million, representing 84.0% of consolidated revenu
  • Operating loss of $27.0 million compared to operating income of $46.1 million a year ago, due to lower revenue, goodwill impairment charges, and continued investments into research and development for the Co-Dx PCR Home Platform
  • Net loss of $14.2 million, compared to net income of $36.7 million in the prior year, representing loss of $0.45 per fully diluted share, compared to $1.23 in 2021
  • Adjusted net income, net of goodwill impairment charges, of $1.2 million, compared to adjusted net income of $36.7 million in the prior year, representing adjusted income of $0.04 per fully diluted share, compared to $1.23 in 2021
  • Adjusted EBITDA loss of $3.1 million
  • Repurchased 3.9 million shares of common stock at an average price of $3.66 per share for an aggregate purchase price of approximately $14.2 million
  • Cash, cash equivalents, and marketable securities of $81.3 million as of December 31, 2022
  • Cash flow from operations of $6.6 million for the twelve months ended December 31, 2022

Dwight Egan, Co-Diagnostics' Chief Executive Officer, said, "The impact of COVID-19 on society decreased considerably during the second half of the year, and resulted in lower demand for high-throughput testing at the centralized lab level. While our overall financial performance has been impacted by these trends, we are pleased with the progress we made against our strategic priorities which support our Co-Dx PCR Home™ platform as we continue to see an emphasis on diagnostics shifting out of the centralized lab settings and towards at-home and point-of-care (POC). The commencement of clinical evaluations announced in February of this year marks an important step toward detection of infectious diseases in at-home and POC settings, with anticipated multiplex panels to follow."

Mr. Egan continued, "Looking ahead, we remain focused on executing the clinical evaluations for our Co-Dx PCR Home platform, including the clinical trials themselves and the analytical studies required to support regulatory submissions. Our mission of creating a new standard for real-time PCR at-home and POC technology continues to be validated. We firmly believe our patented Co-Primers™ technology and patent-pending design of the new Co-Dx PCR Home platform extend our capabilities, aspirations, and potential far beyond COVID-19, and we continue our focus on managing the business and being deliberate in our actions."

Full Year 2022 and Recent Business Highlights:

  • Expanded the OEM agreement with Bio Molecular Systems for the Co-Dx Box™ magnetic induction PCR cycler to encompass 193 countries worldwide
  • Designed and verified two testing products for mpox in response to urgent global health concern generated by that virus
  • Received clearance from Indian regulators for JV CoSara hepatitis B and hepatitis C viral load tests, as well as a high-risk HPV multiplex test
  • Authorized a $30.0 million share repurchase program
  • Recently initiated clinical evaluations for Co-Dx PCR Home platform and initial COVID-19 test
  • Completed strategic additions to the Scientific Advisory Board appointing Carl Wittwer, M.D., Ph.D. as Chairman, as well as Karen C. Carroll, M.D, Noriko Kusukawa, Ph.D., and Anne Wyllie, Ph.D.

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 Home platform is subject to FDA review and is not currently 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 Home™ 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. Additionally, this press release contains adjusted net income (loss), which is a non-GAAP measure defined as net income excluding goodwill impairment charges. The Company believes that adjusted EBITDA and adjusted net income (loss) provide useful information to management and investors relating to its results of operations. The Company's management uses these non-GAAP measures 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 and adjusted net income (loss) provide 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 they allow 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 measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measures is that they exclude 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 measures 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. Reconciliation tables of the net income, the most comparable GAAP financial measure, to adjusted EBITDA and adjusted net income (loss) are 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 within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) that are subject to a number of risks and uncertainties. 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 (i) that we continue to see an emphasis on diagnostics shifting out of the centralized lab settings and towards at-home and point-of-care settings, (ii)anticipated development of multiplex panels, and (iii) that we will successfully complete the clinical trials required to support regulatory submissions. 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 24, 2022, 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






December 31,
2022



December 31,
2021


Assets









Current assets









Cash and cash equivalents


$

22,973,803



$

88,607,234


Marketable investment securities



58,289,066




1,255,266


Accounts receivable, net



3,453,723




20,839,182


Inventory



5,310,473




2,004,169


Income taxes receivable



1,870,419




-


Prepaid expenses and other current assets



761,186




2,338,444


Note receivable



75,000




75,000


Total current assets



92,733,670




115,119,295


Property and equipment, net



2,539,483




1,933,216


Operating lease right-of-use asset



372,115




-


Goodwill



-




14,706,818


Intangible assets, net



26,768,333




27,195,000


Investment in joint venture



672,679




1,004,953


Note receivable



-




75,000


Total assets


$

123,086,280



$

160,034,282


Liabilities and stockholders' equity









Current liabilities









Accounts payable


$

952,297



$

607,506


Accrued expenses, current



934,447




3,859,652


Operating lease liability, current



297,209




-


Contingent consideration liabilities, current



1,689,471




5,767,304


Income taxes payable



-




2,213,088


Deferred revenue



-




150,000


Total current liabilities



3,873,424




12,597,550


Long-term liabilities









Income taxes payable



1,181,284




1,067,853


Deferred tax liability



2,417,987




7,228,444


Operating lease liability



50,708




-


Contingent consideration liabilities



1,042,885




4,665,337


Total long-term liabilities



4,692,864




12,961,634


Total liabilities



8,566,288




25,559,184


Commitments and contingencies (Note 13)









Stockholders' equity









Convertible preferred stock, $0.001 par value; 5,000,000 shares

authorized; 0 shares issued and outstanding as of December 31, 2022

and December 31, 2021, respectively



-




-


Common stock, $0.001 par value; 100,000,000 shares authorized;

34,754,265 shares issued and 30,872,607 shares outstanding as of

December 31, 2022 and 33,819,862 shares issued and outstanding

as of December 31, 2021



34,754




33,820


Treasury stock, at cost; 3,881,658 and 0 shares held as of December

31, 2022 and December 31, 2021, respectively



(14,211,866)




-


Additional paid-in capital



88,472,934




80,271,999


Accumulated other comprehensive income



293,140




-


Accumulated earnings



39,931,030




54,169,279


Total stockholders' equity



114,519,992




134,475,098


Total liabilities and stockholders' equity


$

123,086,280



$

160,034,282


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)




Years Ended December 31,




2022



2021


Revenue


$

34,218,209



$

97,885,603


Cost of revenue



5,481,092




11,574,944


Gross profit



28,737,117




86,310,659


Operating expenses









Sales and marketing



7,344,628




13,397,813


General and administrative



14,262,963




11,550,615


Research and development



17,438,098




14,961,916


Depreciation and amortization



1,282,718




335,363


Goodwill impairment charges



15,388,546




-


Total operating expenses



55,716,953




40,245,707


Income (loss) from operations



(26,979,836)




46,064,952


Other income (expense)









Interest income



704,044




45,631


Loss on disposition of assets



(138,117)




(44,355)


Gain on remeasurement of acquisition contingencies



7,899,644




-


Loss on equity method investment in joint venture



(332,969)




(430,433)


Total other income (expense)



8,132,602




(429,157)


Income (loss) before income taxes



(18,847,234)




45,635,795


Income tax provision (benefit)



(4,608,985)




8,977,231


Net income (loss)


$

(14,238,249)



$

36,658,564


Other comprehensive income









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


$

293,140



$

-


Total other comprehensive income


$

293,140



$

-


Comprehensive income (loss)


$

(13,945,109)



$

36,658,564











Earnings per common share:









Basic


$

(0.45)



$

1.27


Diluted


$

(0.45)



$

1.23


Weighted average shares outstanding:









Basic



31,479,028




28,874,555


Diluted



31,479,028




29,903,686


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES


Reconciliation of net income to adjusted EBITDA: 




Years Ended December 31,




2022



2021


Net income (loss)


$

(14,238,249)



$

36,658,564


Interest income



(704,044)




(45,631)


Depreciation and amortization



1,282,718




335,363


Transaction costs



139,342




151,305


Change in fair value of contingent consideration



(7,899,644)




-


Stock-based compensation expense



7,543,223




5,509,404


Income tax provision



(4,608,985)




8,977,231


Goodwill impairment charges



15,388,546




-


Adjusted EBITDA


$

(3,097,093)



$

51,586,236


 

Reconciliation of net income (loss) to adjusted net income (loss):




Years Ended December 31,




2022



2021


Net income (loss)


$

(14,238,249)



$

36,658,564


Goodwill impairment charges



15,388,546




-


Adjusted net income (loss)


$

1,150,297



$

36,658,564


 


Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-inc-reports-full-year-2022-financial-results-301774548.html

SOURCE Co-Diagnostics

FAQ

What were Co-Diagnostics' Q4 2022 earnings results?

Co-Diagnostics reported a revenue of $34.2 million for full-year 2022, a significant decrease from $97.9 million in 2021.

What is the significance of the Co-Dx PCR Home platform for CODX?

The Co-Dx PCR Home platform aims to transition diagnostic testing from centralized labs to at-home and point-of-care settings.

How did CODX manage its share repurchase program in 2022?

Co-Diagnostics repurchased 3.9 million shares at an average price of $3.66 per share, totaling approximately $14.2 million.

What were the major financial challenges faced by CODX in 2022?

The company experienced a revenue decline of 65% and an operating loss of $27.0 million due to decreased demand for COVID-19 testing.

What are the future plans for Co-Diagnostics after the 2022 results?

The company focuses on executing clinical evaluations for the Co-Dx PCR Home platform and advancing regulatory submissions.

Co-Diagnostics, Inc.

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