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.

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

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


 

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SOURCE Co-Diagnostics

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