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

SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Dx," or the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended March 31, 2024.

First Quarter 2024 Financial Results:

    --  Revenue of $0.5 million, down from $0.6 million during the prior year.
        Grant revenue totaled $0.2 million while product revenue totaled $0.3
        million
    --  Operating expenses of $10.5 million increased by 4.4% from the prior
        year due to an increase in research and development costs incurred for
        the development of tests currently in our pipeline
    --  Operating loss of $10.3 million compared to operating loss of $10.0
        million in Q1 2023
    --  Net loss of $9.3 million, compared to net loss of $5.8 million in the
        prior year, representing a loss of $0.31 per fully diluted share,
        compared to a loss of $0.20 per fully diluted share in the prior year
    --  Adjusted EBITDA loss of $8.4 million compared to $7.2 million in Q1 2023
    --  Cash, cash equivalents, and marketable securities of $50.0 million as of
        March 31, 2024

First Quarter and Recent 2024 Business Highlights:

    --  Appointed Richard Abbott as President of Co-Diagnostics. Also appointed
        David Nielsen as Chief Operations Officer (COO), Christopher Thurston as
        Chief Technology Officer (CTO), and Seth Egan as Chief Commercialization
        Officer (CCO)
    --  Inaugurated a new manufacturing facility in South Salt Lake to
        manufacture our patented Co-Primers® oligonucleotides, the Co-Dx(TM)
        PCR Pro(TM) instrument, and test cups for the new Co-Dx PCR platform
    --  Delivered a keynote address at the 5(th) Annual MarketsandMarkets
        conference in London, which included an update of continued expansion of
        the CoSara manufacturing facility in India to enable greater capacity
        for in-house manufacturing of reagents, equipment and consumables, along
        with the ability to manufacture Co-Primers

"We are extremely encouraged by our first quarter progress and believe that we are well positioned to meet our 2024 goals," said Dwight Egan, Co-Diagnostics' Chief Executive Officer. "Co-Diagnostics was pleased to announce the opening of our new manufacturing facility in Salt Lake and continued facility expansion in India, which will soon enable in-house Co-Primers, instrument, and test manufacturing at a low cost. We remain committed to delivering a 510(k) submission to the FDA for our new instrument and COVID-19 test kit in the near future and driving development of our TB, multiplex respiratory, and HPV tests throughout the remainder of the year."

"This is an exciting time for Co-Diagnostics and we truly believe in the disruptive and unique nature of our new platform. We look forward to beginning clinical evaluations for our multiplex test later this year and plan to provide updates on our new platform and pipeline progress as they come," 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.co-dx.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://co-dx.com.

*The Co-Dx PCR platform (including the PCR Home(TM), PCR Pro(TM), 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, and stock-based compensation. 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 that our expansion in India will soon enable in-house manufacturing at a low cost, our commitment to deliver a 510(k) submission to the FDA for our new instrument and COVID-19 test kit in the near future, and our plan to 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)




                                                                                                                                                                                                                                                                                                      March 31, 2024                   December 31, 2023



     Assets



     Current assets



     Cash and cash equivalents                                                                                                                                                                                                                                                            $
        23,099,251          $
         14,916,878



     Marketable investment securities                                                                                                                                                                                                                                                           26,864,435                 43,631,510



     Accounts receivable, net                                                                                                                                                                                                                                                                      434,868                    303,926



     Inventory, net                                                                                                                                                                                                                                                                              1,549,812                  1,664,725



     Income taxes receivable                                                                                                                                                                                                                                                                                                  26,955



     Prepaid expenses and other current assets                                                                                                                                                                                                                                                   1,750,467                  1,597,114



     Total current assets                                                                                                                                                                                                                                                                       53,698,833                 62,141,108



     Property and equipment, net                                                                                                                                                                                                                                                                 3,183,116                  3,035,729



     Operating lease right-of-use asset                                                                                                                                                                                                                                                          2,758,757                  2,966,774



     Intangible assets, net                                                                                                                                                                                                                                                                     26,328,000                 26,403,667



     Investment in joint venture                                                                                                                                                                                                                                                                   702,427                    773,382



     Total assets                                                                                                                                                                                                                                                                         $
        86,671,133          $
         95,320,660



     Liabilities and stockholders' equity



     Current liabilities



     Accounts payable                                                                                                                                                                                                                                                                      $
        2,027,607           $
         1,482,109



     Accrued expenses                                                                                                                                                                                                                                                                            1,324,779                  2,172,959



     Operating lease liability, current                                                                                                                                                                                                                                                            859,912                    838,387



     Contingent consideration liabilities, current                                                                                                                                                                                                                                                 750,877                    891,666



     Deferred revenue                                                                                                                                                                                                                                                                              306,477                    362,449



     Total current liabilities                                                                                                                                                                                                                                                                   5,269,652                  5,747,570



     Long-term liabilities



     Income taxes payable                                                                                                                                                                                                                                                                          679,018                    659,186



     Operating lease liability                                                                                                                                                                                                                                                                   1,931,164                  2,152,180



     Contingent consideration liabilities                                                                                                                                                                                                                                                          438,638                    748,109



     Total long-term liabilities                                                                                                                                                                                                                                                                 3,048,820                  3,559,475



     Total liabilities                                                                                                                                                                                                                                                                           8,318,472                  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 March 31, 2024 and December 31, 2023, respectively



     Common stock, $0.001 par value; 100,000,000 shares authorized; 36,127,096 shares issued and 31,278,418 shares outstanding as of March 31, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023                                                          36,127                     36,108



     Treasury stock, at cost; 4,848,678 shares held as of March 31, 2024 and December 31, 2023, respectively                                                                                                                                                                                  (15,575,795)              (15,575,795)



     Additional paid-in capital                                                                                                                                                                                                                                                                 98,379,651                 96,808,436



     Accumulated other comprehensive income                                                                                                                                                                                                                                                        226,555                    146,700



     Accumulated earnings (deficit)                                                                                                                                                                                                                                                            (4,713,877)                 4,598,166



     Total stockholders' equity                                                                                                                                                                                                                                                                 78,352,661                 86,013,615



     Total liabilities and stockholders' equity                                                                                                                                                                                                                                           $
        86,671,133          $
         95,320,660


                                                                
              
                CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

                                                
              
                CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

                                                                             
              
                (Unaudited)




                                                                                                                                                                Three Months Ended March 31,


                                                                                                                                                           2024                                  2023



     Product revenue                                                                                                                            $
           252,745                     $
              601,957



     Grant revenue                                                                                                                                       215,109



     Total revenue                                                                                                                                       467,854                                 601,957



     Cost of revenue                                                                                                                                     234,505                                 502,241



     Gross profit                                                                                                                                        233,349                                  99,716



     Operating expenses



     Sales and marketing                                                                                                                               1,563,682                               1,706,331



     General and administrative                                                                                                                        2,918,803                               3,013,965



     Research and development                                                                                                                          5,679,678                               5,014,060



     Depreciation and amortization                                                                                                                       330,573                                 316,010



     Total operating expenses                                                                                                                         10,492,736                              10,050,366



     Loss from operations                                                                                                                           (10,259,387)                            (9,950,650)



     Other income, net



     Interest income                                                                                                                                     362,733                                 202,372



     Realized gain on investments                                                                                                                        228,070                                 418,082



     Gain on remeasurement of acquisition contingencies                                                                                                  450,260                               1,037,672



     Gain (loss) on equity method investment in joint venture                                                                                           (70,955)                                277,322



     Total other income, net                                                                                                                             970,108                               1,935,448



     Loss before income taxes                                                                                                                        (9,289,279)                            (8,015,202)



     Income tax provision (benefit)                                                                                                                       22,764                             (2,259,811)



     Net loss                                                                                                                                $
          (9,312,043)                $
              (5,755,391)



     Other comprehensive loss



     Change in net unrealized gains on marketable securities, net of tax                                                                                  79,855                                 178,621



     Total other comprehensive income                                                                                                            $
           79,855                     $
              178,621



     Comprehensive loss                                                                                                                      $
          (9,232,188)                $
              (5,576,770)





     Loss per common share:



     Basic and diluted                                                                                                                           $
           (0.31)                     $
              (0.20)



     Weighted average shares outstanding:



     Basic and diluted                                                                                                                                29,842,874                              29,483,540


                                           
              
               CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

                                                
              
               GAAP AND NON-GAAP MEASURES

                                                        
             
                (Unaudited)





     
                Reconciliation of net loss to adjusted EBITDA:




                                                                                                                  Three Months Ended March 31,


                                                                                                             2024                                  2023



     Net loss                                                                                       $
     (9,312,043)                $
              (5,755,391)



     Interest income                                                                                     (362,733)                              (202,372)



     Realized gain on investments                                                                        (228,070)                              (418,082)



     Depreciation and amortization                                                                         330,573                                 316,010



     Change in fair value of contingent consideration                                                    (450,260)                            (1,037,672)



     Stock-based compensation expense                                                                    1,571,234                               2,168,742



     Income tax provision (benefit)                                                                         22,764                             (2,259,811)



     Adjusted EBITDA                                                                                $
     (8,428,535)                $
              (7,188,576)

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SOURCE Co-Diagnostics