Full Press Release Details
Inc. Reports Full Year 2022 Financial Results
Results Impacted by Lower Demand for COVID-19 Testing
Initiation of Clinical Evaluations for Co-Dx PCR Home Platform
LAKE CITY, March 16, 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 full year ended December 31, 2022.
Year 2022 Financial Results:
| Revenue of $34.2 million, down from $97.9 million during the prior year primarily due to lower global demand for the Logix Smart COVID-19 tests | ||
| Gross profit of $28.7 million, representing 84.0% of consolidated revenue | ||
| Operating loss of $27.0 million compared to operating income of $46.1 million a year ago, due to lower revenue, goodwill impairment charges, and continued investments into research and development for the Co-Dx PCR Home Platform | ||
| Net loss of $14.2 million, compared to net income of $36.7 million in the prior year, representing loss of $0.45 per fully diluted share, compared to $1.23 in 2021 | ||
| Adjusted net income, net of goodwill impairment charges, of $1.2 million, compared to adjusted net income of $36.7 million in the prior year, representing adjusted income of $0.04 per fully diluted share, compared to $1.23 in 2021 | ||
| Adjusted EBITDA loss of $3.1 million | ||
| Repurchased 3.9 million shares of common stock at an average price of $3.66 per share for an aggregate purchase price of approximately $14.2 million | ||
| Cash, cash equivalents, and marketable securities of $81.3 million as of December 31, 2022 | ||
| Cash flow from operations of $6.6 million for the twelve months ended December 31, 2022 |
Egan, Co-Diagnostics' Chief Executive Officer, said, "The impact of COVID-19 on society decreased considerably during the
second half of the year, and resulted in lower demand for high-throughput testing at the centralized lab level. While our overall financial
performance has been impacted by these trends, we are pleased with the progress we made against our strategic priorities which support
our Co-Dx PCR Home platform as we continue to see an emphasis on diagnostics shifting out of the centralized lab settings and
towards at-home and point-of-care (POC). The commencement of clinical evaluations announced in February of this year marks an
important step toward detection of infectious diseases in at-home and POC settings, with anticipated multiplex panels to follow."
Egan continued, "Looking ahead, we remain focused on executing the clinical evaluations for our Co-Dx PCR Home platform, including
the clinical trials themselves and the analytical studies required to support regulatory submissions. Our mission of creating
a new standard for real-time PCR at-home and POC technology continues to be validated. We firmly believe our patented Co-Primers
technology and patent-pending design of the new Co-Dx PCR Home platform extend our capabilities, aspirations, and potential far beyond
COVID-19, and we continue our focus on managing the business and being deliberate in our actions."
Year 2022 and Recent Business Highlights:
| Expanded the OEM agreement with Bio Molecular Systems for the Co-Dx Box magnetic induction PCR cycler to encompass 193 countries worldwide | ||
| Designed and verified two testing products for mpox in response to urgent global health concern generated by that virus | ||
| Received clearance from Indian regulators for JV CoSara hepatitis B and hepatitis C viral load tests, as well as a high-risk HPV multiplex test | ||
| Authorized a $30.0 million share repurchase program | ||
| Recently initiated clinical evaluations for Co-Dx PCR Home platform and initial COVID-19 test | ||
| Completed strategic additions to the Scientific Advisory Board appointing Carl Wittwer, M.D., Ph.D. as Chairman, as well as Karen C. Carroll, M.D, Noriko Kusukawa, Ph.D., and Anne Wyllie, Ph.D. |
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:
ir.codiagnostics.com on the Events & Webcasts page
Call: 844-481-2661 (domestic) or 412-317-0652 (international)
call will be recorded and later made available on the Company's website: https://codiagnostics.com.
Co-Dx PCR Home platform is subject to FDA review and is not currently for sale.
Co-Diagnostics, Inc.:
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.
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. Additionally,
this press release contains adjusted net income (loss), which is a non-GAAP measure defined as net income excluding goodwill impairment
charges. The Company believes that adjusted EBITDA and adjusted net income (loss) provide useful information to management and
investors relating to its results of operations. The Company's management uses these non-GAAP measures 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 and adjusted net income (loss) provide 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 they allow for greater transparency with respect to key metrics used by management in its financial
and operational decision-making.
does not consider the non-GAAP measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The
principal limitation of the non-GAAP financial measures is that they exclude 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
measures 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. Reconciliation tables of the net income, the most
comparable GAAP financial measure, to adjusted EBITDA and adjusted net income (loss) are 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
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA)
that are subject to a number of risks and uncertainties. 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) that we continue to see an emphasis on diagnostics shifting out of the centralized lab settings and towards
at-home and point-of-care settings, (ii)anticipated development of multiplex panels, and (iii) that we will successfully complete
the clinical trials required to support regulatory submissions. 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: Andrew Benson | Investor Relations Contact: Zachary Mizener |
| Head of Investor Relations +1 801-438-1036 | Lambert & Co. +1 616-258-5804 |
| investors@codiagnostics.com | zmizener@lambert.com |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
| December 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 22,973,803 | $ | 88,607,234 | ||||
| Marketable investment securities | 58,289,066 | 1,255,266 | ||||||
| Accounts receivable, net | 3,453,723 | 20,839,182 | ||||||
| Inventory | 5,310,473 | 2,004,169 | ||||||
| Income taxes receivable | 1,870,419 | - | ||||||
| Prepaid expenses and other current assets | 761,186 | 2,338,444 | ||||||
| Note receivable | 75,000 | 75,000 | ||||||
| Total current assets | 92,733,670 | 115,119,295 | ||||||
| Property and equipment, net | 2,539,483 | 1,933,216 | ||||||
| Operating lease right-of-use asset | 372,115 | - | ||||||
| Goodwill | - | 14,706,818 | ||||||
| Intangible assets, net | 26,768,333 | 27,195,000 | ||||||
| Investment in joint venture | 672,679 | 1,004,953 | ||||||
| Note receivable | - | 75,000 | ||||||
| Total assets | $ | 123,086,280 | $ | 160,034,282 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 952,297 | $ | 607,506 | ||||
| Accrued expenses, current | 934,447 | 3,859,652 | ||||||
| Operating lease liability, current | 297,209 | - | ||||||
| Contingent consideration liabilities, current | 1,689,471 | 5,767,304 | ||||||
| Income taxes payable | - | 2,213,088 | ||||||
| Deferred revenue | - | 150,000 | ||||||
| Total current liabilities | 3,873,424 | 12,597,550 | ||||||
| Long-term liabilities | ||||||||
| Income taxes payable | 1,181,284 | 1,067,853 | ||||||
| Deferred tax liability | 2,417,987 | 7,228,444 | ||||||
| Operating lease liability | 50,708 | - | ||||||
| Contingent consideration liabilities | 1,042,885 | 4,665,337 | ||||||
| Total long-term liabilities | 4,692,864 | 12,961,634 | ||||||
| Total liabilities | 8,566,288 | 25,559,184 | ||||||
| Commitments and contingencies (Note 13) | ||||||||
| Stockholders' equity | ||||||||
| Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022 and 33,819,862 shares issued and outstanding as of December 31, 2021 | 34,754 | 33,820 | ||||||
| Treasury stock, at cost; 3,881,658 and 0 shares held as of December 31, 2022 and December 31, 2021, respectively | (14,211,866 | ) | - | |||||
| Additional paid-in capital | 88,472,934 | 80,271,999 | ||||||
| Accumulated other comprehensive income | 293,140 | - | ||||||
| Accumulated earnings | 39,931,030 | 54,169,279 | ||||||
| Total stockholders' equity | 114,519,992 | 134,475,098 | ||||||
| Total liabilities and stockholders' equity | $ | 123,086,280 | $ | 160,034,282 |
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
| Years Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Revenue | $ | 34,218,209 | $ | 97,885,603 | ||||
| Cost of revenue | 5,481,092 | 11,574,944 | ||||||
| Gross profit | 28,737,117 | 86,310,659 | ||||||
| Operating expenses | ||||||||
| Sales and marketing | 7,344,628 | 13,397,813 | ||||||
| General and administrative | 14,262,963 | 11,550,615 | ||||||
| Research and development | 17,438,098 | 14,961,916 | ||||||
| Depreciation and amortization | 1,282,718 | 335,363 | ||||||
| Goodwill impairment charges | 15,388,546 | - | ||||||
| Total operating expenses | 55,716,953 | 40,245,707 | ||||||
| Income (loss) from operations | (26,979,836 | ) | 46,064,952 | |||||
| Other income (expense) | ||||||||
| Interest income | 704,044 | 45,631 | ||||||
| Loss on disposition of assets | (138,117 | ) | (44,355 | ) | ||||
| Gain on remeasurement of acquisition contingencies | 7,899,644 | - | ||||||
| Loss on equity method investment in joint venture | (332,969 | ) | (430,433 | ) | ||||
| Total other income (expense) | 8,132,602 | (429,157 | ) | |||||
| Income (loss) before income taxes | (18,847,234 | ) | 45,635,795 | |||||
| Income tax provision (benefit) | (4,608,985 | ) | 8,977,231 | |||||
| Net income (loss) | $ | (14,238,249 | ) | $ | 36,658,564 | |||
| Other comprehensive income | ||||||||
| Change in net unrealized gains on marketable securities, net of tax | $ | 293,140 | $ | - | ||||
| Total other comprehensive income | $ | 293,140 | $ | - | ||||
| Comprehensive income (loss) | $ | (13,945,109 | ) | $ | 36,658,564 | |||
| Earnings per common share: | ||||||||
| Basic | $ | (0.45 | ) | $ | 1.27 | |||
| Diluted | $ | (0.45 | ) | $ | 1.23 | |||
| Weighted average shares outstanding: | ||||||||
| Basic | 31,479,028 | 28,874,555 | ||||||
| Diluted | 31,479,028 | 29,903,686 |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
AND NON-GAAP MEASURES
of net income to adjusted EBITDA:
| Years Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Net income (loss) | $ | (14,238,249 | ) | $ | 36,658,564 | |||
| Interest income | (704,044 | ) | (45,631 | ) | ||||
| Depreciation and amortization | 1,282,718 | 335,363 | ||||||
| Transaction costs | 139,342 | 151,305 | ||||||
| Change in fair value of contingent consideration | (7,899,644 | ) | - | |||||
| Stock-based compensation expense | 7,543,223 | 5,509,404 | ||||||
| Income tax provision | (4,608,985 | ) | 8,977,231 | |||||
| Goodwill impairment charges | 15,388,546 | - | ||||||
| Adjusted EBITDA | $ | (3,097,093 | ) | $ | 51,586,236 |
of net income (loss) to adjusted net income (loss):
| Years Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Net income (loss) | $ | (14,238,249 | ) | $ | 36,658,564 | |||
| Goodwill impairment charges | 15,388,546 | - | ||||||
| Adjusted net income (loss) | $ | 1,150,297 | $ | 36,658,564 |