EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

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

 

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

Solid cash position and grant funding support long-term strategy

 

SALT LAKE 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.

 

First Quarter 2023 Financial Results:

 

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

 

 

 

 

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, (ii) completion of clinical evaluations for our Co-Dx PCR Home platform, and (iii) clinical trials for our ABC+RSV tests to commence during this upcoming 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 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.

 

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

 

 

 

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   March 31, 2023   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 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

 

 

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS 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

GAAP AND NON-GAAP MEASURES

(Unaudited)

 

Reconciliation of 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