0001493152-22-013017.txt : 20220512 0001493152-22-013017.hdr.sgml : 20220512 20220512160240 ACCESSION NUMBER: 0001493152-22-013017 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220512 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220512 DATE AS OF CHANGE: 20220512 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Co-Diagnostics, Inc. CENTRAL INDEX KEY: 0001692415 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 462609396 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38148 FILM NUMBER: 22917666 BUSINESS ADDRESS: STREET 1: 4049 SOUTH HIGHLAND DRIVE CITY: SALT LAKE CITY STATE: UT ZIP: 84124 BUSINESS PHONE: 8012789769 MAIL ADDRESS: STREET 1: 4049 SOUTH HIGHLAND DRIVE CITY: SALT LAKE CITY STATE: UT ZIP: 84124 8-K 1 form8-k.htm
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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 12, 2022

 

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 May 12, 2022, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its first quarter ended March 31, 2022. 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 May 12, 2022
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: May 12, 2022 By: /s/ Brian Brown
  Name: Brian Brown
  Title:

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

Co-Diagnostics Reports Solid First Quarter 2022 Financial Results

 

Strong results highlighted by record first quarter revenue of $22.7 million and diluted EPS of $0.34

 

SALT LAKE CITY, May 12, 2022— 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 first quarter ended March 31, 2022.

 

First-Quarter 2022 Financial Results:

 

●Revenue of $22.7 million, primarily due to sales of the Logix Smart™ COVID-19 Test
●Gross profit increased to $19.4 million, representing 85.5% of consolidated revenue
●Operating income of $9.8 million compared to $10.3 million a year ago, due to an increase in research and development expense
●Income before taxes of $13.1 million
●Net income of $11.7 million, compared to a net income of $7.9 million in the prior-year first quarter, representing $0.34 per fully diluted share
●Adjusted EBITDA of $11.4 million
●Cash, cash equivalents, and marketable securities totalled $97.4 million as of March 31, 2022, an increase of $7.5 million from December 31, 2021

 

“We are incredibly proud to deliver another solid quarter of growth following our record results in 2021,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “We’ve made substantial progress in the development of our new Co-Dx™ PCR home diagnostic testing platform and look forward to submitting for FDA approval later this year.

 

“Looking forward, we are focused on completing development and FDA submission of the new platform,” continued Egan. “Our strong balance sheet and liquidity continue to position us well for additional investments in research and development that will fund our future growth initiatives. We believe we are at an important point in our growth trajectory that will enable us to expand into new verticals, new markets, and innovative molecular diagnostic solutions.

 

“While we remain very confident about the long-term potential of our business, our ability to accurately forecast Logix Smart™ COVID-19 Test sales through the balance of the year has diminished due to decreased mask mandates in the United States, continued emergence and spread of new variants, and persistently low vaccination rates in many parts of the world. As a result, it has become difficult to predict with any level of precision the cumulative impact of these and other factors on our future financial results. For these reasons, we are not providing quarterly guidance at this time and will reassess this position in the future,” concluded Egan.

 

 
 

 

First Quarter 2022 Business Highlights:

 

●Continued optimization of performance and capabilities of Co-Dx PCR home testing platform in preparation for clinical trials and FDA submission
●CoSara JV received clearance from Indian regulators for hepatitis B viral load and high-risk HPV multiplex tests; CoSara JV approved test count currently stands at 14
●Announced strategic additions to the Scientific Advisory board with the appointments of Carl Wittwer, M.D., Ph.D. as Chairman, and Karen C. Carroll, M.D, Noriko Kusukawa, Ph.D., and Anne Wyllie, Ph.D. who join Company co-founder Brent Satterfield, Ph.D.

 

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: 877-317-6789 (domestic) or 412-317-6789 (international)

 

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

 

 
 

 

About Co-Diagnostics, Inc.:

 

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets new, state-of-the-art diagnostics technologies. 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.

 

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 tables 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 new Co-Dx at-home/point-of-care PCR testing device, (ii) forecast of strong demand for our broad product portfolio across all end markets, and (iii) our strong balance sheet and liquidity will continue to position us well for additional investments in research and development that will fund our future growth initiatives. 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 24, 2022, 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.

 

Company Contact: Investor Relations Contact:
Andrew Benson Zachary Mizener
Head of Investor Relations Lambert & Co.
+1 801-438-1036 +1 616-233-0500
investors@codiagnostics.com zmizener@lambert.com

 

 
 

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   March 31, 2022   December 31, 2021 
Assets          
Current assets          
Cash and cash equivalents  $97,421,739   $88,607,234 
Marketable investment securities   -    1,255,266 
Accounts receivable, net   21,662,403    20,839,182 
Inventory   4,901,057    2,004,169 
Prepaid expenses and other current assets   1,278,598    2,338,444 
Note receivable   75,000    75,000 
Total current assets   125,338,797    115,119,295 
Property and equipment, net   2,252,853    1,933,216 
Operating lease right-of-use asset   604,837    - 
Goodwill   14,808,411    14,706,818 
Intangible assets, net   27,088,333    27,195,000 
Investment in joint venture   983,614    1,004,953 
Note receivable   75,000    75,000 
Total assets  $171,151,845   $160,034,282 
Liabilities and stockholders’ equity          
Current liabilities          
Accounts payable  $1,215,049   $607,506 
Accrued expenses, current   2,613,218    3,859,652 
Operating lease liability, current   283,299    - 
Contingent consideration liabilities, current   4,065,537    5,767,304 
Income taxes payable   4,843,592    2,213,088 
Deferred revenue   -    150,000 
Total current liabilities   13,020,695    12,597,550 
Long-term liabilities          
Income taxes payable   1,284,745    1,067,853 
Deferred tax liability   5,868,728    7,228,444 
Operating lease liability   275,672    - 
Contingent consideration liabilities   2,987,214    4,665,337 
Total long-term liabilities   10,416,359    12,961,634 
Total liabilities   23,437,054    25,559,184 
Stockholders’ equity          
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively   -    - 
Common stock, $0.001 par value; 100,000,000 shares authorized; 33,984,068 and 33,819,862 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively   33,984    33,820 
Additional paid-in capital   81,796,933    80,271,999 
Accumulated earnings   65,883,874    54,169,279 
Total stockholders’ equity   147,714,791    134,475,098 
Total liabilities and stockholders’ equity  $171,151,845   $160,034,282 

 

 
 

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended March 31, 
   2022   2021 
Revenue  $22,699,044   $20,024,769 
Cost of revenue   3,281,951    3,272,565 
Gross profit   19,417,093    16,752,204 
Operating expenses          
Sales and marketing   2,652,148    1,197,546 
General and administrative   2,922,195    2,935,689 
Research and development   3,771,327    2,217,063 
Depreciation and amortization   247,264    67,005 
Total operating expenses   9,592,934    6,417,303 
Income from operations   9,824,159    10,334,901 
Other income (expense)          
Interest income   11,393    14,657 
Loss on disposition of assets   (93,421)   - 
Gain on remeasurement of acquisition contingencies   3,379,890    - 
(Loss) on equity method investment in joint venture   (21,339)   (464,943)
Total other income (expense)   3,276,523    (450,286)
Income before income taxes   13,100,682    9,884,615 
Income tax provision   1,386,087    1,985,640 
Net income  $11,714,595   $7,898,975 
Earnings per common share:          
Basic  $0.35   $0.28 
Diluted  $0.34   $0.26 
Weighted average shares outstanding:          
Basic   33,935,570    28,662,885 
Diluted   34,711,476    30,002,729 

 

 
 

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)

 

Reconciliation of net income to adjusted EBITDA:

 

   Three Months Ended March 31, 
   2022   2021 
Net income  $11,714,595   $7,898,975 
Interest income   (11,393)   (14,657)
Depreciation and amortization   247,264    67,005 
Transaction costs (1)   78,229    - 
Change in fair value of contingent consideration   (3,379,890)   - 
Stock-based compensation expense   1,375,097    1,513,012 
Income tax provision   1,386,087    1,985,640 
Adjusted EBITDA  $11,409,989   $11,449,975 

 

(1) Expenses incurred relating to the acquisitions of Idaho Molecular and Advanced Conceptions

 

 

 

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