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): August 10, 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 August 10, 2023, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended June 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 August 10, 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: August 10, 2023	By:	/s/ Brian Brown
	Name:	Brian Brown
	Title:	Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 99.1

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

Co-Dx receives grant awards from the Bill & Melinda Gates Foundation; NIH RADx® Tech to develop tests on our new Co-Dx PCR Home™ platform

SALT LAKE CITY, August 10, 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 June 30, 2023.

Second Quarter 2023 Financial Results:

	●	Revenue of $0.2 million, down from $5.0 million during the prior year primarily due to the anticipated decline in global demand for the Logix Smart® COVID-19 tests
	●	Operating expenses of $11.7 million increased by 42.1% from the prior year same period due to our pre-commercialization investments in our Co-Dx PCR Home platform*
	●	Operating loss of $12.0 million compared to operating loss of $4.1 million a year ago
	●	Net loss of $8.9 million, compared to net loss of $2.7 million in the prior year second quarter, representing EPS loss of $0.31 per fully diluted share, compared to EPS loss of $0.08 in the prior year period
	●	Adjusted EBITDA loss of $9.6 million
	●	Repurchased 0.4 million shares of common stock at an average price of $1.51 per share for an aggregate purchase price of approximately $0.6 million
	●	Cash, cash equivalents, and marketable securities of $69.1 million as of June 30, 2023

2023 Recent Business Highlights:

	●	NIH awarded the Company $1.2 million as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for completion of its upcoming upper respiratory panel on the Company’s Co-Dx PCR Home testing platform
	●	The company was awarded two grants by the Bill & Melinda Gates Foundation in the amounts of $1.33 million and $987K, to support the development of TB and HPV tests, respectively
	●	Signed lease and began build-out of new manufacturing facility with capacity for up to 12 lines of production; first lines expected to be operational by end of 2023
	●	Received results from a recent usability and analytical study conducted by PATH, which investigated the limit-of-detection and ease-of-use of the Company’s Co-Dx PCR Home platform, running the platform’s COVID-19 assay

Dwight Egan, Co-Diagnostics’ Chief Executive Officer, said, “While sales of our COVID diagnostic kits declined as expected, we continue to strengthen our position as we seek to expand our advanced PCR technology reach beyond the four walls of the lab to the places of greatest unmet need. We remain on track for FDA submission of our new Co-Dx PCR Home platform and initial testing product by the end of this year.”

“We remain steadfast in our strategy and continue to progress toward our mission of making affordable, high-quality real-time PCR diagnostics available to all,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer. “We are making notable progress toward our goals and move into the second half of this year with strong momentum.”

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 Home platform is subject to FDA review and is not currently 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 Home™ 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 (i) completion of development and FDA submission for approval of the Co-Dx PCR Home platform by end of this year and (ii) 12 lines of production with first lines expected to be operational by end of 2023. 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)

	June 30, 2023			December 31, 2022
Assets
Current assets
Cash and cash equivalents	$	13,830,846		$	22,973,803
Marketable investment securities		55,307,146			58,289,066
Accounts receivable, net		1,097,393			3,453,723
Inventory, net		4,691,068			5,310,473
Income taxes receivable		1,439,451			1,870,419
Prepaid expenses and other current assets		981,996			761,187
Note receivable		37,500			75,000
Total current assets		77,385,400			92,733,671
Property and equipment, net		2,795,023			2,539,483
Deferred tax asset		2,012,181			-
Operating lease right-of-use asset		3,228,774			372,115
Intangible assets, net		26,555,000			26,768,333
Investment in joint venture		824,808			672,679
Total assets	$	112,801,186		$	123,086,281
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	1,712,204		$	952,296
Accrued expenses, current		1,628,765			934,447
Operating lease liability, current		772,515			297,209
Contingent consideration liabilities, current		744,172			1,689,471
Deferred revenue		257,999			-
Total current liabilities		5,115,655			3,873,423
Long-term liabilities
Income taxes payable		1,203,975			1,181,284
Deferred tax liability		-			2,417,987
Operating lease liability		2,458,072			50,708
Contingent consideration liabilities		591,107			1,042,885
Total long-term liabilities		4,253,154			4,692,864
Total liabilities		9,368,810			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 June 30, 2023 and December 31, 2022, respectively		-			-
Common stock, $0.001 par value; 100,000,000 shares authorized; 35,348,350 shares issued and 30,788,871 shares outstanding as of June 30, 2023 and 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022		35,348			34,754
Treasury stock, at cost; 4,559,479 and 3,881,658 shares held as of June 30, 2023 and December 31, 2022, respectively		(15,249,796	)		(14,211,866	)
Additional paid-in capital		92,810,883			88,472,935
Accumulated other comprehensive income		579,127			293,140
Accumulated earnings		25,256,815			39,931,031
Total stockholders’ equity		103,432,377			114,519,994
Total liabilities and stockholders’ equity	$	112,801,186		$	123,086,281

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Revenue	$	197,806		$	5,023,226		$	799,763		$	27,722,270
Cost of revenue		459,095			915,432			961,336			4,197,383
Gross profit		(261,289	)		4,107,794			(161,573)			23,524,887
Operating expenses
Sales and marketing		1,732,966			1,472,225			3,439,297			4,124,373
General and administrative		3,713,895			2,468,421			6,727,860			5,390,616
Research and development		5,981,043			3,889,844			10,995,103			7,661,171
Depreciation and amortization		305,246			424,342			621,256			671,606
Total operating expenses		11,733,150			8,254,832			21,783,516			17,847,766
Income (loss) from operations		(11,994,439	)		(4,147,038	)		(21,945,089	)		5,677,121
Other income
Interest income		191,892			61,671			394,264			73,064
Realized gain on investments		411,190			-			829,272			-
(Loss) on disposition of assets		-			(48,740	)		-			(142,161	)
Gain on remeasurement of acquisition contingencies		359,405			812,822			1,397,077			4,192,712
Gain (loss) on equity method investment in joint venture		(125,193	)		(106,525	)		152,129			(127,864	)
Total other income		837,294			719,228			2,772,742			3,995,751
Income (loss) before income taxes		(11,157,145	)		(3,427,810	)		(19,172,347	)		9,672,872
Income tax provision (benefit)		(2,238,320	)		(741,507	)		(4,498,131	)		644,580
Net income (loss)	$	(8,918,825	)	$	(2,686,303	)	$	(14,674,216	)	$	9,028,292
Other comprehensive income (loss)
Change in net unrealized gains on marketable securities, net of tax	$	107,366		$	-		$	285,987		$	-
Total other comprehensive income	$	107,366		$	-		$	285,987		$	-
Comprehensive income (loss)	$	(8,811,459	)	$	(2,686,303	)	$	(14,388,229	)	$	9,028,292

Earnings per common share:
Basic	$	(0.31	)	$	(0.08	)	$	(0.50	)	$	0.28
Diluted	$	(0.31	)	$	(0.08	)	$	(0.50	)	$	0.27
Weighted average shares outstanding:
Basic		29,088,159			32,472,251			29,284,175			32,509,664
Diluted		29,088,159			32,472,251			29,284,175			33,253,612

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)

Reconciliation of net income to adjusted EBITDA:
	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Net income (loss)	$	(8,918,825	)	$	(2,686,303	)	$	(14,674,216	)	$	9,028,292
Interest income		(191,892	)		(61,671	)		(394,264	)		(73,064	)
Realized gain on investments		(411,190	)		-			(829,272	)		-
Depreciation and amortization		305,246			424,342			621,256			671,606
Transaction costs		310			47,943			310			126,171
Change in fair value of contingent consideration		(359,405	)		(812,822	)		(1,397,077	)		(4,192,712	)
Stock-based compensation expense		2,169,800			1,533,286			4,338,542			2,908,381
Income tax provision		(2,238,320	)		(741,507	)		(4,498,131	)		644,580
Adjusted EBITDA	$	(9,644,276	)	$	(2,296,732	)	$	(16,832,852	)	$	9,113,254

Cover	Aug. 10, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 10, 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