Form 8-K - Current report

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): November 9, 2023

CO-DIAGNOSTICS, INC.

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

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

2401 S. 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 pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications 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 of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $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. ☐

Item 2.02. Results of Operations and Financial Condition.

On November 9, 2023, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended September 30, 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.

Item 7.01. Regulation FD. Disclosure.

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

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.:		Description:
99.1		Press Release, dated November 9, 2023
104		Cover Page Interactive 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: November 9, 2023	By:	/s/ Brian Brown
	Name:	Brian Brown
	Title:	Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 99.1

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

Receives grant award from the Bill & Melinda Gates Foundation in the amount of $9.0M for the development of tuberculosis test on Co-Dx™ PCR platform.

SALT LAKE CITY, November 9, 2023— Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended September 30, 2023.

Third Quarter 2023 Financial Results:

	●	Revenue of $2.5 million, down from $5.1 million during the prior year primarily due to the anticipated decline in global demand for COVID-19 tests. Grant revenue totaled $2.3 million while product revenue totaled $0.1 million
	●	Operating expenses of $11.1 million increased by 2.5% from the prior year same period due to investments in our Co-Dx™ PCR platform*
	●	Operating loss of $8.9 million compared to operating loss of $6.5 million a year ago
	●	Net loss of $6.0 million, compared to net loss of $1.4 million in the prior year second quarter, representing a loss of $0.20 per fully diluted share, compared to a loss of $0.04 per fully diluted share in the prior year period
	●	Adjusted EBITDA loss of $6.5 million
	●	Repurchased 149,041 shares of common stock at an average price of $1.12 per share for an aggregate purchase price of approximately $0.2 million
	●	Cash, cash equivalents, and marketable securities of $63.4 million as of September 30, 2023
2023 Recent Business Highlights:
	●	Continue to expect EUA submission to the FDA for our Co-Dx PCR Pro™ platform and COVID-19 assay before the end of 2023
	●	Received additional grant funding from the Bill & Melinda Gates Foundation in the amount of $9.0M, to be applied towards regulatory and clinical validation activities for our tuberculosis test and additional manufacturing and platform development
	●	Appointed Ivory Chang as Chief Regulatory Affairs Officer, who previously worked at multiple large, renowned diagnostic companies, and brings many years of experience in in-vitro diagnostic product and point-of-care regulatory submissions to Co-Diagnostics
	●	Participated in several investor conferences, trade shows, and industry events to share Co-Diagnostics’ vision for increasing accessibility of PCR diagnostics worldwide, the Company’s unique value proposition, and updates on its new platform

Dwight Egan, Co-Diagnostics’ Chief Executive Officer, said, “We are pleased to report $2.3 million in grant revenue, bringing our total revenue to approximately $2.5 million in the third quarter of 2023. We remain excited for the future of Co-Diagnostics and believe that the additional grant funding we recently received further validates the disruptive nature of our platform. The Company expects to finalize an EUA submission to the FDA for the COVID-19 test on our Co-Dx PCR platform by year-end. We anticipate our new platform will serve as the foundation for Co-Diagnostics’ future development initiatives and believe that our patented Co-Primers™ technology allows for reliable, affordable high-quality test results and look forward to delivering our unique platform to the market.”

“We remain committed on our strategy and mission and continue to progress in the development of other test indications beyond Covid-19 for the new platform: TB, multiplex respiratory, and HPV,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer. “We are pleased with our progress this year and believe in the potential for the new platform to have a transformative effect on diagnostics worldwide.”

Conference Call 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 at-home and point-of-care platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not currently available for sale.

About Co-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 at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

Non-GAAP Financial Measures:

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

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

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 completion of development and FDA submission for approval of the Co-Dx PCR platform by end of this year. 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. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors 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 relating to matters discussed in this press release, except as may be required by applicable securities laws.

Investor Relations Contact:

Andrew Benson

Head of Investor Relations

+1 801-438-1036

investors@codiagnostics.com

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

	September 30, 2023			December 31, 2022
Assets
Current assets
Cash and cash equivalents	$	10,239,898		$	22,973,803
Marketable investment securities		53,188,999			58,289,066
Accounts receivable, net		806,704			3,453,723
Inventory, net		4,520,430			5,310,473
Income taxes receivable		1,245,854			1,870,419
Prepaid expenses and other current assets		1,290,146			761,187
Note receivable		18,750			75,000
Total current assets		71,310,781			92,733,671
Property and equipment, net		2,808,339			2,539,483
Deferred tax asset		4,272,002			-
Operating lease right-of-use asset		3,032,337			372,115
Intangible assets, net		26,479,333			26,768,333
Investment in joint venture		778,943			672,679
Total assets	$	108,681,735		$	123,086,281
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	1,416,435		$	952,296
Accrued expenses, current		1,826,639			934,447
Operating lease liability, current		794,516			297,209
Contingent consideration liabilities, current		710,651			1,689,471
Deferred revenue		349,499			-
Total current liabilities		5,097,740			3,873,423
Long-term liabilities
Income taxes payable		1,359,725			1,181,284
Deferred tax liability		-			2,417,987
Operating lease liability		2,250,393			50,708
Contingent consideration liabilities		484,332			1,042,885
Total long-term liabilities		4,094,450			4,692,864
Total liabilities		9,192,190			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 September 30, 2023 and December 31, 2022, respectively		-			-
Common stock, $0.001 par value; 100,000,000 shares authorized; 35,367,100 shares issued and 30,658,580 shares outstanding as of September 30, 2023 and 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022		35,367			34,754
Treasury stock, at cost; 4,708,520 and 3,881,658 shares held as of September 30, 2023 and December 31, 2022, respectively		(15,416,122	)		(14,211,866	)
Additional paid-in capital		94,983,030			88,472,935
Accumulated other comprehensive income		612,649			293,140
Accumulated earnings		19,274,621			39,931,031
Total stockholders’ equity		99,489,545			114,519,994
Total liabilities and stockholders’ equity	$	108,681,735		$	123,086,281

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Product revenue	$	136,533		$	5,094,456		$	936,296		$	32,816,726
Grant revenue		2,320,565			-			2,320,565			-
Total revenue		2,457,098			5,094,456			3,256,861			32,816,726
Cost of revenue		255,772			767,936			1,217,108			4,965,319
Gross profit		2,201,326			4,326,520			2,039,753			27,851,407
Operating expenses
Sales and marketing		1,904,395			1,889,907			5,343,692			6,014,280
General and administrative		3,147,753			3,622,273			9,875,613			9,012,888
Research and development		5,788,789			5,037,461			16,783,892			12,698,632
Depreciation and amortization		296,340			312,494			917,596			984,100
Total operating expenses		11,137,277			10,862,135			32,920,793			28,709,900
(Loss) from operations		(8,935,951	)		(6,535,615	)		(30,881,040	)		(858,493	)
Other income, net
Interest income		322,877			298,184			717,141			371,248
Realized gain on investments		425,446			-			1,254,718			-
Gain (loss) on disposition of assets		(2,578	)		4,044			(2,578	)		(138,117	)
Gain on remeasurement of acquisition contingencies		140,296			2,886,734			1,537,373			7,079,446
Gain (loss) on equity method investment in joint venture		(45,865	)		(129,047	)		106,264			(256,911	)
Total other income, net		840,176			3,059,915			3,612,918			7,055,666
Income (loss) before income taxes		(8,095,775	)		(3,475,700	)		(27,268,122	)		6,197,173
Income tax (benefit)		(2,113,581	)		(2,114,638	)		(6,611,712	)		(1,470,058	)
Net income (loss)	$	(5,982,194	)	$	(1,361,062	)	$	(20,656,410	)	$	7,667,231
Other comprehensive income (loss)
Change in net unrealized gains on marketable securities, net of tax	$	33,522		$	-		$	319,509		$	-
Total other comprehensive income	$	33,522		$	-		$	319,509		$	-
Comprehensive income (loss)	$	(5,948,672	)	$	(1,361,062	)	$	(20,336,901	)	$	7,667,231

Earnings (loss) per common share:
Basic	$	(0.20	)	$	(0.04	)	$	(0.70	)	$	0.24
Diluted	$	(0.20	)	$	(0.04	)	$	(0.70	)	$	0.23
Weighted average shares outstanding:
Basic		29,361,300			31,321,368			29,306,572			32,109,213
Diluted		29,361,300			31,321,368			29,306,572			33,002,539

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)

Reconciliation of net income to adjusted EBITDA:

	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Net income (loss)	$	(5,982,194	)	$	(1,361,062	)	$	(20,656,410	)	$	7,667,231
Interest income		(322,877	)		(298,184	)		(717,141	)		(371,248	)
Realized gain on investments		(425,446	)		-			(1,254,718	)		-
Depreciation and amortization		296,340			312,494			917,596			984,100
Transaction costs		-			13,038			310			139,209
Change in fair value of contingent consideration		(140,296	)		(2,886,734	)		(1,537,373	)		(7,079,446	)
Stock-based compensation expense		2,172,165			2,230,434			6,510,708			5,138,815
Income tax provision		(2,113,581	)		(2,114,638	)		(6,611,712	)		(1,470,058	)
Adjusted EBITDA	$	(6,515,889	)	$	(4,104,652	)	$	(23,348,740	)	$	5,008,603

Cover	Nov. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 09, 2023
Entity File Number	1-38148
Entity Registrant Name	CO-DIAGNOSTICS, INC
Entity Central Index Key	0001692415
Entity Tax Identification Number	46-2609363
Entity Incorporation, State or Country Code	UT
Entity Address, Address Line One	2401 S. Foothill Drive
Entity Address, Address Line Two	Suite D
Entity Address, City or Town	Salt Lake City
Entity Address, State or Province	UT
Entity Address, Postal Zip Code	84109
City Area Code	(801)
Local Phone Number	438-1036
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CODX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false