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      Co-Diagnostics, Inc. Announces Q2 2020 Results on Form 10-Q

      Company reports robust sales of COVID-19 tests and net income per common share of $0.43

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

      News provided by

      Co-Diagnostics

      Aug 13, 2020, 16:01 ET

      Share this article

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      SALT LAKE CITY, Aug. 13, 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 the filing of its operating results for the 3 month period ending June 30, 2020 on SEC Form 10-Q, and provided updates on Company developments.

      Q2 2020 Highlights:

      • Company continues COVID-19 test sales and reports $24.04 million of revenue in Q2;
      • Net profit of $12.6 million in quarter and net income per common share of $0.43;
      • Stockholders' equity increased to $33.4 million compared to $1.7 million at the beginning of the year.
      • Gross margins of 70% on sales of Logix Smart™ COVID-19 test kits;
      • CoSara Diagnostics, Company's India joint venture, receives authorization from CDSCO in India to manufacture and sell COVID-19 tests and records profit for the 2nd Quarter and YTD;
      • Received FDA Emergency Use Authorization for COVID-19 test kit on April 3, 2020;
      • Cash on hand was $18.6 million as of June 30, 2020, an increase of $17.7 million over 12/31/2019;
      • Company is included in the Russell 2000® and Russell 3000® Index, widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.

      Q3 2020 Mid-Quarter Highlights:

      • Company records COVID-19 test and equipment sales orders approaching $50 million YTD, including joint venture sales in India, through mid-third quarter (unaudited);
      • Receives purchase orders from public and private organizations in nearly 50 countries and over 25 states in the U.S. YTD;
      • Company nears completion of principal design work and verification for Flu A, Flu B, and COVID-19 multiplex panel with anticipated deployment during Q3;
      • Company announced that its partner Clinical Reference Lab has received FDA Emergency Use Authorization for CRL Rapid Response™, a saliva-based COVID-19 test that can be self-administered at home, work or any other setting and then tested using Co-Diagnostics' Logix Smart COVID-19 tests based on patented CoPrimer™ technology.

      "In the last 4 months since Co-Diagnostics received emergency use authorization from the FDA, the Company has successfully grown our internationally recognized business and brand. With clients in over 50 countries, 25 U.S. states, and validations of test accuracy from regulatory bodies of numerous countries around the world, Co-Diagnostics has established a distribution platform that we believe will continue to support sales and profitability as our tests have gained widespread acceptance in the market. We have created a test menu and established the production capacity to meet demand for tests as the nations of the world continue to battle the pandemic, and believe these efforts will continue to bolster the Company's durability in the months and years to come," said Dwight Egan, Chief Executive Officer.

      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.
      CONDENSED CONSOLIDATED BALANCE SHEETS
      (Unaudited)




      June 30, 2020



      December 31, 2019


      ASSETS:









      Current Assets









      Cash and cash equivalents


      $

      18,550,437



      $

      893,138


      Accounts receivables, net



      5,349,876




      131,382


      Inventory



      10,110,786




      197,168


      Prepaid expenses



      521,180




      362,566


      Total current assets



      34,532,279




      1,584,254


      Other Assets









      Property and equipment, net



      473,376




      196,832


      Investment in joint venture



      1,416,480




      434,240


      Total other assets



      1,889,856




      631,072











      Total assets


      $

      36,422,135



      $

      2,215,326











      LIABILITIES AND STOCKHOLDERS' EQUITY:


















      Current Liabilities









      Accounts payable


      $

      1,127,709



      $

      5,959


      Accrued expenses



      691,385




      200,788


      Accrued expenses (related party)



      120,000




      120,000


      Deferred revenue



      1,045,548




      1,323


      Total current liabilities



      2,984,642




      328,070


      Long-term Liabilities, net of current portion









      Accrued expenses-long-term (related party)



      80,000




      150,000


      Total long-term liabilities, net of current portion



      80,000




      150,000


      Total liabilities



      3,064,642




      478,070











      STOCKHOLDERS' EQUITY









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



      —




      26











      Common stock, $0.001 par value, 100,000,000 shares authorized; 27,991,042 and 17,342,922 shares issued and outstanding, as of June 30, 2020 and December 31, 2019, respectively.



      27,991




      17,343


      Additional paid-in capital



      46,726,869




      26,687,701


      Accumulated deficit



      (13,397,367)




      (24,967,814)


      Total stockholders' equity



      33,357,493




      1,737,256











      Total liabilities and stockholders' equity


      $

      36,422,135



      $

      2,215,326


      CO – DIAGNOSTICS, INC.
      CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
      (Unaudited)




      For the Three Months
      Ended June 30,



      For the Six Months
      Ended June 30,




      2020



      2019



      2020



      2019


      Net revenue


      $

      24,040,274



      $

      61,574



      $

      25,588,802



      $

      64,974


      Cost of revenue



      8,344,674




      38,809




      8,826,414




      39,261


      Gross profit



      15,695,600




      22,765




      16,762,388




      25,713


      Operating expenses:

















      Sales and marketing



      390,191




      252,076




      658,674




      508,179


      Administrative and general



      2,191,034




      807,769




      3,650,518




      1,448,132


      Research and development



      750,249




      312,590




      1,150,271




      659,896


      Depreciation and amortization



      25,218




      16,094




      45,966




      29,762


      Total operating expenses



      3,356,692




      1,388,529




      5,505,429




      2,645,969


      Income (loss) from operations



      12,338,908




      (1,365,764)




      11,256,959




      (2,620,256)


      Other expense:

















      Interest income



      38,173




      19,640




      45,748




      20,048


      Interest expense



      —




      —




      —




      (106,427)


      Gain on disposition of assets



      —




      —




      —




      850


      Gain (loss) on equity method investment in joint venture



      258,559




      1,728




      267,740




      (7,000)


      Total other expense



      296,732




      21,368




      313,488




      (92,529)


      Income (loss) before income taxes



      12,635,640




      (1,344,396)




      11,570,447




      (2,712,785)


      Provision for income taxes



      —




      —




      —




      —


      Net income (loss)


      $

      12,635,640



      $

      (1,344,396)



      $

      11,570,447



      $

      (2,712,785)



















      Basic income (loss) per common share


      $

      0.46



      $

      (0.08)



      $

      0.42



      $

      (0.16)



















      Diluted income (loss) per common share


      $

      0.43



      $

      (0.08)



      $

      0.40



      $

      (0.16)



















      Weighted average common shares outstanding basic



      27,582,229




      17,017,964




      27,605,137




      16,544,926



















      Weighted average common shares outstanding diluted



      29,152,222




      17,017,964




      29,094,475




      16,544,926


      SOURCE Co-Diagnostics

      Modal title

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