Co-Diagnostics, Inc. Announces Q3 2020 Financial Results Including YTD Net Income per Common Share of $1.07

SALT LAKE CITY, Nov. 16, 2020 /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 third quarter ended September 30, 2020 and provided updates on Company developments, including receipt of CE markings for both the recently developed Logix Smart ABC (Influenza A/B, SARS-CoV-2) test kit for simultaneous detection of Influenza A, Influenza B, and SARS-CoV-2 and Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex test kit for detection of SARS-CoV-2, the virus that causes COVID-19.

Q3 2020 Highlights:

    --  Company continues COVID-19 test sales and reports $21.8 million of
        revenue in Q3;
    --  Quarterly net income of $15.7 million and net income per diluted common
        share of $0.53;
    --  Year-to-date net income of $29.7 million and $1.07 per diluted common
    --  Additionally, CoSara Diagnostics, the Company's India joint venture,
        also continues COVID-19 sales and reports $3.0 million of revenue in Q3,
        nearly a 3-fold increase over Q2;
    --  Quarterly net gain from investment in CoSara increased to $748,000 from
        $250,000 in Q2;
    --  Stockholders' equity increased to $52.7 million compared to $1.7 million
        at the beginning of the year.
    --  Continues to show strong gross margins of 73% on quarterly sales;
    --  Cash, cash equivalents and marketable securities were $27.3 million as
        of September 30, 2020, an increase of $26.4 million over 12/31/2019.

Q4 2020 Mid-Quarter Highlights:

    --  Company completes design work and verification for influenza A,
        influenza B, and COVID-19 ("ABC") multiplex panel and began distributing
        on a Research Use Only basis to laboratories in the first week of
    --  CE markings received for both Co-Diagnostics "ABC" and SARS-CoV-2 2-gene
        tests; both tests are designed for use in saliva and other respiratory
        tract samples like nasal swabs, and sputum;
    --  Indian CDSCO approval for SARS-CoV-2 2-gene multiplex test expected to
        be granted soon;
    --  Company announced that its partner Clinical Reference Lab has begun
        selling its CRL Rapid Response(TM) COVID-19 test directly to consumers,
        which uses a simple saliva collection device that can be
        self-administered at home, work or any other setting. The test uses
        CoPrimer(TM) probes and primers developed by Co-Diagnostics with high
        degrees of sensitivity and specificity;
    --  Company receives increased patent protection from the United States
        Patent and Trademark Office for the novel CoPrimer(TM) technology used
        in the Company's molecular diagnostic tests;
    --  Company demonstrates that the CoPrimer platform technology can be used
        to identify the presence of SARS-CoV-2 in human saliva samples without
        first requiring costly and time-consuming RNA extraction, and plans
        development projects to incorporate extraction-free products in upcoming

"Co-Diagnostics continues to see widespread uptake of our COVID-19 test domestically and abroad, and we believe our customer and distributor bases are laying the foundation for a strong future," said Dwight Egan, Chief Executive Officer. "Development projects both completed and ongoing have helped position Co-Diagnostics as a key player in the battle against the coronavirus pandemic, including receipt today of two important CE markings that will allow our ABC and COVID-19 2-gene tests to be sold as in vitro diagnostics in areas that accept CE markings as valid regulatory approval. The strength and flexibility of our technology platform as illustrated by our enhanced patent protection and successful proof of concept in extraction-free COVID-19 tests underscore our core competency as a forward-looking technology company with a expanding menu of critical diagnostic tools."

The Company will host an earnings call at 4:30 pm EDT today. Participants can register for access to the webcast here. The call will be recorded and later made available on the Company's website.

About Emergency Use Authorization:
The Co-Diagnostics SARS-CoV-2 Test has been made available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service's (HHS's) declaration that circumstances exist to justify the use of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA cleared IVD. However, based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of COVID-19. The EUAs for these tests are in effect for the duration of the COVID-19 emergency, unless terminated or revoked (after which the tests may no longer be used). An FDA cleared IVD should be used instead of an IVD under EUA, when applicable and available.

About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. 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.

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 the (i) use of funding proceeds, (ii) expansion of product distribution, (iii) acceleration of initiatives in liquid biopsy and SNP detection, (iv) use of the Company's liquid biopsy tests by laboratories, (v) capital resources and runway needed to advance the Company's products and markets, (vi) increased sales in the near-term, (vii) flexibility in managing the Company's balance sheet, (viii) anticipation of business expansion, and (ix) benefits in research and worldwide accessibility of the CoPrimer technology and its cost-saving and scientific advantages. 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. 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.



                                                                                                                           September 30,                  December 31,
                                                                                                                                    2020                           2019


            Current assets

            Cash and cash equivalents                                                                                                   $
        21,230,362                 $

            Marketable investment securities                                                                                                   6,050,000

            Accounts receivable, net                                                                                                          10,640,417                           131,382

            Inventory                                                                                                                         10,726,982                           197,168

            Prepaid expenses                                                                                                                     384,642                           362,566

            Deferred tax asset                                                                                                                 2,914,781

            Total current assets                                                                                                              51,947,184                         1,584,254

            Property and equipment, net                                                                                                          538,279                           196,832

            Investment in joint venture                                                                                                        2,165,037                           434,240

            Total assets                                                                                                                $
        54,650,500               $

              Liabilities and stockholders' equity

            Current liabilities

            Accounts payable                                                                                                               $
        250,465                   $

            Accrued expenses                                                                                                                     786,063                           200,788

            Accrued expenses (related party)                                                                                                     120,000                           120,000

            Deferred revenue                                                                                                                     657,925                             1,323

            Total current liabilities                                                                                                          1,814,453                           328,070

            Accrued expenses-long-term (related party)                                                                                            60,000                           150,000

            Total liabilities                                                                                                                  1,874,453                           478,070

              Commitments and contingencies (Note 8)

              Stockholders' equity

            Convertible preferred stock, $0.001 par value; 5,000,000 shares                                                                                                            26
    authorized; 0 and 25,600 shares issued and outstanding as of
    September 30, 2020 and December 31, 2019, respectively

            Common Stock, $0.001 par value; 100,000,000 shares authorized;                                                                        28,161                            17,343
    28,161,259 and 17,342,922 shares issued and outstanding as of
    September 30, 2020 and December 31, 2019, respectively

            Additional paid-in capital                                                                                                        48,044,352                        26,687,701

            Accumulated earnings (deficit)                                                                                                     4,703,534                      (24,967,814)

            Total stockholders' equity                                                                                                        52,776,047                         1,737,256

            Total liabilities and stockholders' equity                                                                                  $
        54,650,500               $

                CO - DIAGNOSTICS, INC.



                                                                    Three Months Ended                                      Nine Months Ended
                                                        September 30, 2020                                      September 30, 2020

                                                  2020                                2019                                  2020              2019

              Revenue                                   $
              21,818,753                              $
              41,434                     $
           47,407,555    $

              Cost of revenue                                        5,821,281                                          20,365                              12,278,326             59,626

              Gross profit                                          15,997,472                                          21,069                              35,129,229             46,782

              Operating expenses

              Sales and marketing                                      798,474                                         262,360                               1,457,148            770,539

              Administrative and general                             2,203,417                                       1,060,763                               5,853,935          2,508,895

              Research and development                                 921,889                                         331,027                               2,072,160            990,923

              Depreciation and                                          35,490                                          17,006                                  81,456             46,768

              Total operating expenses                               3,959,270                                       1,671,156                               9,464,699          4,317,125

              Income (loss) from                                    12,038,202                                     (1,650,087)                             25,664,530        (4,270,343)

              Other income (expense)

              Interest income                                           29,992                                          12,207                                  75,740             32,255

              Interest expense                                                                                           (10)                                                (106,437)

              Gain on disposition of assets                                                                                                                                        850

              Gain (loss) on equity method                             748,557                                       (109,876)                              1,016,297          (116,876)
    investment in joint venture

              Total other income                                       778,549                                        (97,679)                              1,092,037          (190,208)

              Income (loss) before income                           12,816,751                                     (1,747,766)                             26,756,567        (4,460,551)

              Income tax provision (benefit)                       (2,914,781)                                                                           (2,914,781)

              Net income (loss)                         $
              15,731,532                           $
            (1,747,766)                    $
           29,671,348  $

              Earnings (loss) per common

              Basic                                           $
              0.56                              $
              (0.10)                        $
             1.13     $

              Diluted                                         $
              0.53                              $
              (0.10)                        $
             1.07     $

              Weighted average shares

              Basic                                                 28,084,267                                      17,328,787                              26,172,439         16,809,085

              Diluted                                               29,597,792                                      17,328,787                              27,621,531         16,809,085

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SOURCE Co-Diagnostics