Second quarter results impacted by volume declines; Further progress on the development of the Co-Dx PCR Home platform

SALT LAKE CITY, Aug. 11, 2022 /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 second quarter ended June 30, 2022.

Co-Diagnostics Official Logo (PRNewsfoto/Co-Diagnostics)

Second Quarter 2022 Financial Results:

  • Revenue of $5.0 million, down from $27.4 million during the prior year period, due primarily to lower demand of the Logix Smart™ COVID-19 Test
  • Gross profit of $4.1 million, representing 81.8% of consolidated revenue stemming from inefficiencies in lower sales volumes
  • Operating loss of $4.1 million compared to operating income of $11.8 million a year ago, due to lower sales volumes and continued investments into research and development
  • Net loss of $2.7 million, compared to a net income of $9.8 million in the prior-year second quarter, representing a loss of $0.08 per fully diluted share
  • Adjusted EBITDA loss of $2.3 million
  • Cash, cash equivalents, and marketable securities of $96.0 million as of June 30, 2022
  • Cash flow from operations of $1.7 million for the second quarter ended June 30, 2022

Dwight Egan, Co-Diagnostics' Chief Executive Officer, remarked "Our second quarter results reflect lower volumes for our Logix Smart™ COVID-19 Test, which we believe is primarily the result of a reduction in mandated testing in travel and public venues and in government funding for testing programs. The Company has initiatives underway intended to actively address these pressures, such as growing our international distributor network, expanding our infectious disease testing menu including monkeypox, and most importantly, our upcoming at-home/point-of-care testing platform. We anticipate these initiatives will potentially be bolstered by recurring COVID surges as we have previously experienced."

Mr. Egan further stated that "progress continues in the development and optimization of the Co-Dx™ PCR Home testing platform* and its manufacturing capacity to meet the anticipated demand for gold-standard PCR in at-home and point-of-care settings. We believe that the need for accurate and reliable COVID-19 testing will persist as new variants emerge, and we continue to invest time and resources to meet the evolving demand for COVID-19 and other infectious diseases globally. We remain confident in our business strategy and in our unique portfolio of innovative testing products that extend far beyond COVID-19."

Second Quarter 2022 and Recent Business Highlights:
  • Indian JV CoSara received clearance from Indian regulators for Hepatitis C viral load test
  • Completed principal design for monkeypox virus test and shipped testing reagents to international distributor
  • Announced expansion of its OEM agreement with Bio Molecular Systems ("BMS") for the Co-Dx Box™ magnetic induction PCR cycler, to encompass 193 countries worldwide
  • Continued optimization of the Co-Dx PCR Home device, which has been showcased at several tradeshows and conferences
  • Initiated previously announced repurchase of shares to return value to Company shareholders
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: 877-317-6789 (domestic) or 412-317-6789 (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 new, state-of-the-art diagnostics technologies. The Company's technology is 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 to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

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 tables 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 (i) completion of development and FDA submission for approval of the new Co-Dx at-home/point-of-care PCR testing device, (ii) that there will be recurring COVID surges, and (iii) our confidence that the need for accurate and reliable COVID-19 testing will persist as new variants emerge. 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

(Unaudited)




June 30, 2022



December 31, 2021


Assets









Current assets









Cash and cash equivalents


$

86,045,405



$

88,607,234


Marketable investment securities



9,951,550




1,255,266


Accounts receivable, net



12,260,009




20,839,182


Inventory



4,705,921




2,004,169


Prepaid expenses and other current assets



1,569,374




2,338,444


Note receivable



35,200




75,000


Total current assets



114,567,459




115,119,295


Property and equipment, net



2,421,349




1,933,216


Operating lease right-of-use asset



530,033




-


Goodwill



15,388,546




14,706,818


Intangible assets, net



26,981,667




27,195,000


Investment in joint venture



877,089




1,004,953


Note receivable



75,000




75,000


Total assets


$

160,841,143



$

160,034,282


Liabilities and stockholders' equity









Current liabilities









Accounts payable


$

848,379



$

607,506


Accrued expenses, current



1,818,773




3,859,652


Operating lease liability, current



287,900




-


Contingent consideration liabilities, current



3,761,084




5,767,304


Income taxes payable



-




2,213,088


Deferred revenue



-




150,000


Total current liabilities



6,716,136




12,597,550


Long-term liabilities









Income taxes payable



1,464,024




1,067,853


Deferred tax liability



5,310,573




7,228,444


Operating lease liability



201,266




-


Contingent consideration liabilities



2,678,204




4,665,337


Total long-term liabilities



9,654,067




12,961,634


Total liabilities



16,370,203




25,559,184


Commitments and contingencies (Note 12)









Stockholders' equity









Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively



-




-


Common stock, $0.001 par value; 100,000,000 shares authorized; 34,313,432 shares issued and 33,780,992 shares outstanding as of June 30, 2022 and 33,819,862 shares issued and outstanding as of December 31, 2021



34,313




33,820


Treasury stock, at cost; 532,440 and 0 shares held as of June 30, 2022 and December 31, 2021, respectively



(2,599,478)




-


Additional paid-in capital



83,838,533




80,271,999


Accumulated earnings



63,197,572




54,169,279


Total stockholders' equity



144,470,940




134,475,098


Total liabilities and stockholders' equity


$

160,841,143



$

160,034,282


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)




Three Months Ended June 30,



Six Months Ended June 30,




2022



2021



2022



2021


Revenue


$

5,023,226



$

27,358,140



$

27,722,270



$

47,382,909


Cost of revenue



915,432




2,504,355




4,197,383




5,776,920


Gross profit



4,107,794




24,853,785




23,524,887




41,605,989


Operating expenses

















Sales and marketing



1,472,225




5,853,313




4,124,373




7,050,859


General and administrative



2,468,421




2,468,433




5,390,616




5,404,122


Research and development



3,889,844




4,669,160




7,661,171




6,886,223


Depreciation and amortization



424,342




71,714




671,606




138,719


Total operating expenses



8,254,832




13,062,620




17,847,766




19,479,923


Income from operations



(4,147,038)




11,791,165




5,677,121




22,126,066


Other income (expense)

















Interest income



61,671




10,529




73,064




25,186


(Loss) on disposition of assets



(48,740)




-




(142,161)




-


Gain on remeasurement of acquisition contingencies



812,822




-




4,192,712




-


Gain (loss) on equity method investment in joint venture



(106,525)




128,595




(127,864)




(336,348)


Total other income (expense)



719,228




139,124




3,995,751




(311,162)


Income (loss) before income taxes



(3,427,810)




11,930,289




9,672,872




21,814,904


Income tax provision



(741,507)




2,145,076




644,580




4,130,716


Net income (loss)


$

(2,686,303)



$

9,785,213



$

9,028,292



$

17,684,188


Earnings per common share:

















Basic


$

(0.08)



$

0.34



$

0.27



$

0.62


Diluted


$

(0.08)



$

0.33



$

0.26



$

0.59


Weighted average shares outstanding:

















Basic



33,472,251




28,794,047




32,509,664




28,728,828


Diluted



33,472,251




29,741,265




33,253,612




29,833,955


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)


Reconciliation of net income to adjusted EBITDA:




Three Months Ended June 30,



Six Months Ended June 30,




2022



2021



2022



2021


Net income


$

(2,686,303)



$

9,785,213



$

9,028,292



$

17,684,188


Interest income



(61,671)




(10,529)




(73,064)




(25,186)


Depreciation and amortization



424,342




71,714




671,606




138,719


Transaction costs



47,943




-




126,171




-


Change in fair value of contingent consideration



(812,822)




-




(4,192,712)




-


Stock-based compensation expense



1,533,286




927,338




2,908,381




2,440,347


Income tax provision



(741,507)




2,145,076




644,580




4,130,716


Adjusted EBITDA


$

(2,296,732)



$

12,918,812



$

9,113,254



$

24,368,784


 

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SOURCE Co-Diagnostics

Copyright 2022 PR Newswire

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