Co-Diagnostics, Inc. Reports Full Year 2023 Financial Results
Full Year 2023 Financial Results:
- Revenue of
$6.8 million , down from$34.2 million during the prior year primarily due to the decline in global demand for the Logix Smart® COVID-19 tests. Grant revenue totaled$5.8 million while product revenue totaled$1.0 million - Operating expenses of
$45.3 million decreased by 18.6% from the prior year due to goodwill impairment charges in the prior year, offset by an increase in research and development costs incurred for the development of our Co-Dx™ PCR platform in the current year - Operating loss of
$42.7 million compared to operating loss of$27.0 million in 2022 - Net loss of
$35.3 million , compared to net loss of$14.2 million in the prior year, representing a loss of$1.20 per fully diluted share, compared to a loss of$0.45 per fully diluted share in the prior year - Adjusted EBITDA loss of
$33.0 million - Repurchased approximately 967,000 shares of common stock at an average price of
$1.41 per share for an aggregate purchase price of approximately$1.4 million - Cash, cash equivalents, and marketable securities of
$58.5 million as ofDecember 31, 2023
Full Year 2023 Business Highlights:
- Initiated and completed the clinical evaluations for the first test on the new Co-Dx PCR point-of-care and at-home platform
- Submitted an EUA to the FDA in December for our Co-Dx PCR Pro™ instrument, mobile app, and Co-Dx COVID-19 test kit
- Awarded grant funding in the aggregate amount of approximately
$12.6 million in 2023, to be applied towards regulatory and clinical validation activities for the development of our tuberculosis (TB) test, upper respiratory multiplex (flu A/B, COVID-19, and RSV) panel, and human papillomavirus (HPV) test, which include:- Three awards from the
Bill and Melinda Gates Foundation to support the development of tuberculosis and HPV tests and expansion of manufacturing capacity; and - An award from the
NIH as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for upper respiratory multiplex panel
- Three awards from the
- Appointed
Ivory Chang as Chief Regulatory Affairs Officer.Ms. Chang previously worked at multiple large, renowned diagnostic companies, and brings many years of experience toCo-Diagnostics in in-vitro diagnostic product and point-of-care regulatory submissions - Built out new manufacturing facility which will serve to support production of our test cups and Co-Dx PCR Pro instruments
"We are pleased to have made great progress towards our strategic goals in the fourth quarter, highlighted by an Emergency Use Authorization submission to the FDA for our Co-Dx PCR Pro™ instrument, mobile app, and COVID-19 test," said
"We remain excited for 2024 and look forward to providing updates on our test development and platform.
Conference Call and Webcast
Webcast: ir.co-dx.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://co-dx.com.
*The Co-Dx PCR 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 yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.
About
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) continued development and FDA submissions for the Co-Dx PCR platform and (ii) our belief that our EUA submission will serve as a steppingstone in our effort to decentralize PCR diagnostics and to expand to the point-of-care and at-home settings. 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
CONSOLIDATED BALANCE SHEETS |
|
|||||||
|
|
|||||||
|
|
|
|
|
|
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,916,878 |
|
|
$ |
22,973,803 |
|
Marketable investment securities |
|
|
43,631,510 |
|
|
|
58,289,066 |
|
Accounts receivable, net |
|
|
303,926 |
|
|
|
3,453,723 |
|
Inventory, net |
|
|
1,664,725 |
|
|
|
5,310,473 |
|
Income taxes receivable |
|
|
26,955 |
|
|
|
1,870,419 |
|
Prepaid expenses and other current assets |
|
|
1,597,114 |
|
|
|
761,187 |
|
Note receivable |
|
|
- |
|
|
|
75,000 |
|
Total current assets |
|
|
62,141,108 |
|
|
|
92,733,671 |
|
Property and equipment, net |
|
|
3,035,729 |
|
|
|
2,539,483 |
|
Operating lease right-of-use asset |
|
|
2,966,774 |
|
|
|
372,115 |
|
Intangible assets, net |
|
|
26,403,667 |
|
|
|
26,768,333 |
|
Investment in joint venture |
|
|
773,382 |
|
|
|
672,679 |
|
Total assets |
|
$ |
95,320,660 |
|
|
$ |
123,086,281 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,482,109 |
|
|
$ |
952,296 |
|
Accrued expenses, current |
|
|
2,172,959 |
|
|
|
934,447 |
|
Operating lease liability, current |
|
|
838,387 |
|
|
|
297,209 |
|
Contingent consideration liabilities, current |
|
|
891,666 |
|
|
|
1,689,471 |
|
Deferred revenue |
|
|
362,449 |
|
|
|
- |
|
Total current liabilities |
|
|
5,747,570 |
|
|
|
3,873,423 |
|
Long-term liabilities |
|
|
|
|
|
|
|
|
Income taxes payable |
|
|
659,186 |
|
|
|
1,181,284 |
|
Deferred tax liability |
|
|
- |
|
|
|
2,417,987 |
|
Operating lease liability |
|
|
2,152,180 |
|
|
|
50,708 |
|
Contingent consideration liabilities |
|
|
748,109 |
|
|
|
1,042,885 |
|
Total long-term liabilities |
|
|
3,559,475 |
|
|
|
4,692,864 |
|
Total liabilities |
|
|
9,307,045 |
|
|
|
8,566,287 |
|
Commitments and contingencies (Note 12) |
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Convertible preferred stock, |
|
|
- |
|
|
|
- |
|
Common stock, |
|
|
36,108 |
|
|
|
34,754 |
|
|
|
|
(15,575,795) |
|
|
|
(14,211,866) |
|
Additional paid-in capital |
|
|
96,808,436 |
|
|
|
88,472,935 |
|
Accumulated other comprehensive income (loss) |
|
|
146,700 |
|
|
|
293,140 |
|
Accumulated earnings |
|
|
4,598,166 |
|
|
|
39,931,031 |
|
Total stockholders' equity |
|
|
86,013,615 |
|
|
|
114,519,994 |
|
Total liabilities and stockholders' equity |
|
$ |
95,320,660 |
|
|
$ |
123,086,281 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|
|||||||
|
|
|||||||
|
|
Years Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Product revenue |
|
$ |
991,473 |
|
|
$ |
34,218,209 |
|
Grant revenue |
|
|
5,820,565 |
|
|
|
- |
|
Total revenue |
|
|
6,812,038 |
|
|
|
34,218,209 |
|
Cost of revenue |
|
|
4,184,949 |
|
|
|
5,481,093 |
|
Gross profit |
|
|
2,627,089 |
|
|
|
28,737,116 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
6,860,815 |
|
|
|
7,344,628 |
|
General and administrative |
|
|
14,279,441 |
|
|
|
14,262,963 |
|
Research and development |
|
|
22,962,593 |
|
|
|
17,438,098 |
|
Depreciation and amortization |
|
|
1,230,474 |
|
|
|
1,282,718 |
|
|
|
|
- |
|
|
|
15,388,546 |
|
Total operating expenses |
|
|
45,333,323 |
|
|
|
55,716,953 |
|
Loss from operations |
|
|
(42,706,234) |
|
|
|
(26,979,837) |
|
Other income, net |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,161,913 |
|
|
|
704,045 |
|
Realized gain on investments |
|
|
2,243,059 |
|
|
|
- |
|
Loss on disposition of assets |
|
|
(2,578) |
|
|
|
(138,117) |
|
Gain on remeasurement of acquisition contingencies |
|
|
1,092,581 |
|
|
|
7,899,644 |
|
Gain (loss) on equity method investment in joint venture |
|
|
100,703 |
|
|
|
(332,969) |
|
Total other income, net |
|
|
4,595,678 |
|
|
|
8,132,603 |
|
Loss before income taxes |
|
|
(38,110,556) |
|
|
|
(18,847,234) |
|
Income tax benefit |
|
|
(2,777,691) |
|
|
|
(4,608,985) |
|
Net loss |
|
$ |
(35,332,865) |
|
|
$ |
(14,238,249) |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
Change in net unrealized gains on marketable securities, net of tax |
|
$ |
(146,440) |
|
|
$ |
293,140 |
|
Total other comprehensive income (loss) |
|
$ |
(146,440) |
|
|
$ |
293,140 |
|
Comprehensive loss |
|
$ |
(35,479,305) |
|
|
$ |
(13,945,109) |
|
|
|
|
|
|
|
|
|
|
Loss per common share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(1.20) |
|
|
$ |
(0.45) |
|
Diluted |
|
$ |
(1.20) |
|
|
$ |
(0.45) |
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
29,346,599 |
|
|
|
31,479,028 |
|
Diluted |
|
|
29,346,599 |
|
|
|
31,479,028 |
|
GAAP AND NON-GAAP MEASURES
|
|
|||||||
Reconciliation of net loss to adjusted EBITDA: |
|
|||||||
|
|
Years Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Net loss |
|
$ |
(35,332,865) |
|
|
$ |
(14,238,249) |
|
Interest income |
|
|
(1,161,913) |
|
|
|
(704,045) |
|
Realized gain on investments |
|
|
(2,243,059) |
|
|
|
- |
|
Depreciation and amortization |
|
|
1,230,474 |
|
|
|
1,282,718 |
|
Transaction costs |
|
|
310 |
|
|
|
139,342 |
|
Change in fair value of contingent consideration |
|
|
(1,092,581) |
|
|
|
(7,899,644) |
|
Stock-based compensation expense |
|
|
8,336,855 |
|
|
|
7,543,223 |
|
Income tax benefit |
|
|
(2,777,691) |
|
|
|
(4,608,985) |
|
|
|
|
- |
|
|
|
15,388,546 |
|
Adjusted EBITDA |
|
$ |
(33,040,470) |
|
|
$ |
(3,097,094) |
|
|
|
|||||||
Reconciliation of net loss to adjusted net income (loss): |
|
|||||||
|
|
|||||||
|
|
Years Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Net income (loss) |
|
$ |
(35,332,865) |
|
|
$ |
(14,238,249) |
|
|
|
|
- |
|
|
|
15,388,546 |
|
Adjusted net income (loss) |
|
$ |
(35,332,865) |
|
|
$ |
1,150,297 |
|
View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-inc-reports-full-year-2023-financial-results-302089736.html
SOURCE