PR Newswire | Nov 16, 2020 04:05PM EST

Income per Common Share of $1.07

11/16 15:04 CST

Co-Diagnostics, Inc. Announces Q3 2020 Financial Results Including YTD Net Income per Common Share of $1.07Company also announces receipt of CE markings for both Logix Smart ABC and SARS-CoV-2 2-gene tests SALT LAKE CITY, Nov. 16, 2020

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 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(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 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, December 31, 2020 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 sharesauthorized; 0 and 25,600 shares issued and outstanding as of - 26September 30, 2020 and December 31, 2019, respectively

Common Stock, $0.001 par value; 100,000,000 shares authorized;28,161,259 and 17,342,922 shares issued and outstanding as of 28,161 17,343September 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 $ 2,215,326

CO - DIAGNOSTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

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 $ 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 35,490 17,006 81,456 46,768amortization

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)operations

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)(expense)

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

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 commonshare:

Basic $ 0.56 $ (0.10) $ 1.13 $ (0.27)

Diluted $ 0.53 $ (0.10) $ 1.07 $ (0.27)

Weighted average sharesoutstanding:

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