8-K - CODX - Equibles

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of the

Securities

Exchange Act of 1934

Date of report (Date of earliest event reported): May 11, 2023

CO-DIAGNOSTICS,

INC.

(Exact name of small business issuer as specified in its charter)

Utah	1-38148	46-2609363
(State<br> or other jurisdiction of	(Commission	(IRS<br> Employer
incorporation<br> or organization)	File<br> Number)	Identification<br> Number)

2401S. Foothill Drive, Suite D, Salt Lake City, Utah 84109

(Address of principal executive offices)

(801)438-1036

(Issuer’s telephone number)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications<br> pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant<br> to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications<br> pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications<br> pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title<br> of each class	Trading<br> Symbol(s)	Name<br> of each exchange on which registered
Common Stock, par value<br> $0.001 per share	CODX	The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item2.02. Results of Operations and Financial Condition.

On May 11, 2023, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its first quarter ended March 31, 2023. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

Item7.01. Regulation FD. Disclosure.

The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.

Item9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.:	Description:
99.1	Press Release, dated May 11, 2023
104	Cover Page Interactive<br> Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

****	CO-DIAGNOSTICS, INC.
Date: May 11, 2023	By:	/s/ Brian Brown
	Name:	Brian Brown
	Title:	Chief<br> Financial Officer<br><br> <br>(Principal<br> Financial and Accounting Officer)

Exhibit99.1

Co-Diagnostics,Inc. Reports First Quarter 2023 Financial Results

Clinicaltrials for Co-Dx PCR Home™ platform remain on track;

Solidcash position and grant funding support long-term strategy

SALTLAKE CITY, May 11, 2023— 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 quarter ended March 31, 2023.

FirstQuarter 2023 Financial Results:

●	Revenue<br> of $0.6 million, down from $22.7 million during the prior year primarily due to lower global<br> demand for the Logix Smart™ COVID-19 tests
●	Gross<br> profit of $0.1 million, representing 16.6% of consolidated revenue
●	Operating<br> loss of $10.0 million compared to operating income of $9.8 million a year ago, due to lower<br> revenue and continued investments into research and development for the Co-Dx PCR Home™<br> Platform
●	Net<br> loss of $5.8 million, compared to net income of $11.7 million in the prior year, representing<br> EPS loss of $0.20 per fully diluted share, compared to EPS of $0.34 in 2022
●	Adjusted<br> EBITDA loss of $7.2 million
●	Repurchased<br> 0.3 million shares of common stock at an average price of $1.56 per share for an aggregate<br> purchase price of approximately $0.5 million
●	Cash,<br> cash equivalents, and marketable securities of $75.3 million as of March 31, 2023

Dwight Egan, Co-Diagnostics’ Chief Executive Officer, said, “Our financial performance during the quarter reflects the expected decline in COVID-related sales year-over-year. However, we continue to advance our longer-term strategy, most notably with progress in our clinical evaluations for our Co-Dx PCR Home™ platform. We believe that the innovation of this new platform has been validated after recently receiving notification of various grant awards, which we expect will be the subject of future press releases.”

Mr. Egan continued, “Looking ahead, we remain focused in our strategy and will continue to leverage our assets and impressive team to deliver innovative and affordable diagnostic testing solutions. To help guide and measure our progress through the remainder of this year, we have established a set of goals we anticipate achieving. We expect completion of clinical evaluations for our Co-Dx PCR Home™ platform and submission to the FDA by the end of this calendar year. We also anticipate clinical trials for our ABC+RSV tests (both for clinical laboratories and on the new platform) to commence during this upcoming flu season.”

ConferenceCall and Webcast

Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:

Webcast: ir.codiagnostics.com on the Events & Webcasts page

Conference Call: 844-481-2661 (domestic) or 412-317-0652 (international)

The call will be recorded and later made available on the Company’s website: https://codiagnostics.com.

The Co-Dx PCR Home platform is subject to FDA review and is not currently for sale.

AboutCo-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company’s technologies are 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 for its Co-Dx PCR Home™ platform and to locate genetic markers for use in applications other than infectious disease.

Non-GAAPFinancial Measures:

Thispress release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, incometax (benefit) expense, net interest (income) expense, stock-based compensation, and one-time transaction related costs. The Company believesthat adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’smanagement uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and forbudgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to usein evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, manyof which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metricsused by management in its financial and operational decision-making.

Managementdoes not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. Theprincipal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recordedin the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financialmeasure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, butshould not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparableGAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliationand not to rely on any single financial measure to evaluate the company’s business.

Forward-LookingStatements:

Thispress release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,”“expects,” “estimates,” “intends,” “may,” “plans,” “will” andsimilar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they existat the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release includestatements regarding (i) completion of development and FDA submission for approval of the Co-Dx PCR Home platform, (ii) completionof clinical evaluations for our Co-Dx PCR Home platform, and (iii) clinical trials for our ABC+RSV tests to commence during thisupcoming flu season. 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 pressrelease are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipatedresults will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our RiskFactors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 16, 2023,and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relatingto matters discussed in this press release, except as may be required by applicable securities laws.

Company Contact:	Investor Relations Contact:
Andrew<br> Benson	William<br> Stack
Head<br> of Investor Relations	Lambert<br> & Co.
+1<br> 801-438-1036	+1<br> 616-258-5804
investors@codiagnostics.com	wstack@lambert.com

CO-DIAGNOSTICS,INC. AND SUBSIDIARIES

CONSOLIDATEDBALANCE SHEETS

(Unaudited)

			December 31, 2022
Assets
Current assets
Cash and cash equivalents	6,359,380		$	22,973,803
Marketable investment securities	68,920,535			58,289,066
Accounts receivable, net	2,702,196			3,453,723
Inventory, net	5,294,653			5,310,473
Income taxes receivable	1,695,480			1,870,419
Prepaid expenses and other current assets	913,175			761,187
Note receivable	37,500			75,000
Total current assets	85,922,919			92,733,671
Property and equipment, net	2,510,083			2,539,483
Operating lease right-of-use asset	952,176			372,115
Intangible assets, net	26,661,667			26,768,333
Investment in joint venture	950,001			672,679
Total assets	116,996,846		$	123,086,281
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	829,819		$	952,296
Accrued expenses, current	1,492,611			934,447
Operating lease liability, current	277,290			297,209
Contingent consideration liabilities, current	992,229			1,689,471
Deferred revenue	18,120			-
Total current liabilities	3,610,069			3,873,423
Long-term liabilities
Income taxes payable	1,193,080			1,181,284
Deferred tax liability	203,335			2,417,987
Operating lease liability	658,137			50,708
Contingent consideration liabilities	702,455			1,042,885
Total long-term liabilities	2,757,007			4,692,864
Total liabilities	6,367,076			8,566,287
Commitments and contingencies (Note 10)
Stockholders’ equity
Convertible preferred stock, 0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively	-			-
Common stock, 0.001 par value; 100,000,000 shares authorized; 34,823,015 shares issued and 30,632,345 shares outstanding as of March 31, 2023 and 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022	34,823			34,754
Treasury stock, at cost; 4,190,670 and 3,881,658 shares held as of March 31, 2023 and December 31, 2022, respectively	(14,694,062	)		(14,211,866	)
Additional paid-in capital	90,641,608			88,472,935
Accumulated other comprehensive income	471,761			293,140
Accumulated earnings	34,175,640			39,931,031
Total stockholders’ equity	110,629,770			114,519,994
Total liabilities and stockholders’ equity	116,996,846		$	123,086,281

All values are in US Dollars.

See accompanying notes to unaudited condensed consolidated financial statements

CO-DIAGNOSTICS,INC. AND SUBSIDIARIES

CONSOLIDATEDSTATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Unaudited)

	Three Months Ended March 31,
	2023			2022
Revenue	$	601,957		$	22,699,044
Cost of revenue		502,241			3,281,951
Gross profit		99,716			19,417,093
Operating expenses
Sales and marketing		1,706,331			2,652,148
General and administrative		3,013,965			2,922,195
Research and development		5,014,060			3,771,327
Depreciation and amortization		316,010			247,264
Total operating expenses		10,050,366			9,592,934
Income (loss) from operations		(9,950,650	)		9,824,159
Other income
Interest income		202,372			11,393
Realized gain on investments		418,082			-
(Loss) on disposition of assets		-			(93,421	)
Gain on remeasurement of acquisition contingencies		1,037,672			3,379,890
Gain (loss) on equity method investment in joint venture		277,322			(21,339	)
Total other income		1,935,448			3,276,523
Income (loss) before income taxes		(8,015,202	)		13,100,682
Income tax provision (benefit)		(2,259,811	)		1,386,087
Net income (loss)	$	(5,755,391	)	$	11,714,595
Other comprehensive income
Change in net unrealized gains on marketable securities, net of tax	$	178,621		$	-
Total other comprehensive income	$	178,621		$	-
Comprehensive income (loss)	$	(5,576,770	)	$	11,714,595
Earnings per common share:
Basic	$	(0.20	)	$	0.35
Diluted	$	(0.20	)	$	0.34
Weighted average shares outstanding:
Basic		29,483,540			33,935,570
Diluted		29,483,540			34,711,476

See accompanying notes to unaudited condensed consolidated financial statements

CO-DIAGNOSTICS,INC. AND SUBSIDIARIES

GAAPAND NON-GAAP MEASURES

(Unaudited)

Reconciliationof net income to adjusted EBITDA:

	Three Months Ended March 31,
	2023			2022
Net income (loss)	$	(5,755,391	)	$	11,714,595
Interest income		(202,372	)		(11,393	)
Realized gain on investments		(418,082	)		-
Depreciation and amortization		316,010			247,264
Transaction costs		-			133
Change in fair value of contingent consideration		(1,037,672	)		-
Stock-based compensation expense		2,168,742			1,375,097
Income tax provision		(2,259,811	)		1,386,087
Adjusted EBITDA	$	(7,188,576	)	$	14,711,783