EXHIBIT 99.1

 

 

 

 

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

 

Company also announces receipt of CE markings for both Logix Smart ABC and SARS-CoV-2 2-gene tests

 

Salt Lake City, Utah – November 16, 2020 –

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 share;
  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 October;
  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™ 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™ 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™ 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 offerings.

 

 
 

 

“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.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   September 30, 2020   December 31, 2019 
Assets          
Current assets          
Cash and cash equivalents  $21,230,362   $893,138 
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   $2,215,326 
Liabilities and stockholders’ equity          
Current liabilities          
Accounts payable  $250,465   $5,959 
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 authorized; 0 and 25,600 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively   -    26 
Common Stock, $0.001 par value; 100,000,000 shares authorized; 28,161,259 and 17,342,922 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively   28,161    17,343 
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   $2,215,326 

 

 
 

 

CO – DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended
September 30, 2020
   Nine Months Ended
September 30, 2020
 
   2020   2019   2020   2019 
Revenue  $21,818,753   $41,434   $47,407,555   $106,408 
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 amortization   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 operations   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 investment in joint venture   748,557    (109,876)   1,016,297    (116,876)
Total other income (expense)   778,549    (97,679)   1,092,037    (190,208)
Income (loss) before income taxes   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   $(4,460,551)
Earnings (loss) per common share:                    
Basic  $0.56   $(0.10)  $1.13   $(0.27)
Diluted  $0.53   $(0.10)  $1.07   $(0.27)
Weighted average shares outstanding:                    
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 

 

Company Contact: Investor Relations Contact:
Andrew Benson Keith Pinder
Head of Investor Relations Landon Capital
+1 801-438-1036 +1.404.995.6671
investors@codiagnostics.com kpinder@landoncapital.net

 

 

 


The following information was filed by Codiagnostics, Inc. (CODX) on Monday, November 16, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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