CODX

MKT CAP $4MP/E —DIV YIELD —FCF YIELD -684.37%REV TTM $721K −28.1%NET INCOME −$47.1MNET CASH $3.4M52W 0.64 – 37.80SEC XBRL · TTM TO Invalid Date

How CODX rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Business Overview Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including molecular tools for detection of infectious diseases.
CODX’s technical advance involves a novel, proprietary approach to polymerase chain reaction (“PCR”) test design of primer and probe structure (“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA.
We have developed a portable diagnostic device and test system designed for point-of-care and at-home use.
In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use.
Following engagement with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life.
While the Company believes that the matter identified during the review process could have been addressed through additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (“ABCR”).
Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process.
Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings.
Accordingly, clinical performance studies for the ABCR test are currently underway.
Our Logix Smart® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days.
Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow for the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins.
Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user’s needs.
Using our proprietary test design system and reagents, we have designed and obtained regulatory clearance in the European Community and in India (along with our joint venture, CoSara) to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus.
In addition to testing for infectious diseases, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications.
We, in conjunction with our customers, have designed tests that identify genetic traits in plant and animal genomes.
RESULTS OF OPERATIONS Results of Operations for the Years Ended December 31, 2025 and 2024 The table below provides a comparison of our operating results for the year ended December 31, 2025 as compared to the year ended December 31, 2024.
Years Ended December 31, Year Change 2025 2024 Change % Product revenue $ 418,205 $ 770,048 $ (351,843 ) -46 % Grant revenue 204,284 3,145,112 (2,940,828 ) -94 % Total revenue 622,489 3,915,160 (3,292,671 ) -84 % Cost of revenue 222,377 999,124 (776,747 ) -78 % Gross profit 400,112 2,916,036 (2,515,924 ) -86 % Operating expenses Sales and marketing 2,381,131 4,483,339 (2,102,208 ) -47 % General and administrative 9,058,283 16,157,152 (7,098,869 ) -44 % Research and development 19,137,242 20,979,589 (1,842,347 ) -9 % Depreciation and amortization 1,106,808 1,377,266 (270,458 ) -20 % Impairment charges 18,882,000 - 18,882,000 - Total operating expenses 50,565,464 42,997,346 7,568,118 18 % Loss from operations (50,165,352 ) (40,081,310 ) (10,084,042 ) 25 % Other income Interest income, net 292,932 1,091,825 (798,893 ) -73 % Realized gain on investments 683,365 870,745 (187,380 ) -22 % Gain (loss) on disposition of assets (82,421 ) 8,291 (90,712 ) -1094 % Gain on remeasurement of acquisition contingencies 805,863 714,876 90,987 13 % Loss on equity method investment in joint venture (46,301 ) (186,067 ) 139,766 -75 % Total other income, net 1,653,438 2,499,670 (846,232 ) -34 % Loss before income taxes (48,511,914 ) (37,581,640 ) (10,930,274 ) 29 % Income tax provision (benefit) (1,615,978 ) 57,368 (1,673,346 ) -2917 % Net loss $ (46,895,936 ) $ (37,639,008 ) $ (9,256,928 ) 25 % Revenues For the year ended December 31, 2025, we generated $0.6 million of revenue compared to revenue of $3.9 million in the year ended December 31, 2024.
The decrease in revenue of $3.3 million was primarily due to lower grant revenues, as the majority of revenue for grants previously awarded was recognized in the prior year.
Cost of Revenues and Gross Profit Cost of revenues decreased by $0.8 million from $1.0 million for the year ended December 31, 2024 to $0.2 million for the year ended December 31, 2025.
Included within cost of revenues is a decrease of approximately $0.1 million for the year ended December 31, 2025, and a decrease of approximately $0.1 million for the year ended December 31, 2024, related to reserves against certain raw materials and finished goods inventories.
Operating Expenses Total operating expenses were $50.6 million for the year ended December 31, 2025, compared to total operating expenses of $43.0 million for the year ended December 31, 2024.
The increase in operating expenses was primarily due to the impairment charge recognized for in-process research and development intangible assets, partially offset by decreased legal expenses, stock-based compensation expense, and personnel related expenses.
Sales and marketing expenses for the year ended December 31, 2025, were $2.4 million compared to $4.5 million for the year ended December 31, 2024.
The decrease of $2.1 million primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses.
General and administrative expenses for the year ended December 31, 2025, were $9.1 million compared to $16.2 million for the year ended December 31, 2024.
The decrease of $7.1 million was primarily due to decreases in legal expense, stock-based compensation expense and consulting and professional services expense, partially offset by increased expenses related to transaction advisory services and fees.
Research and development expenses for the year ended December 31, 2025, were $19.1 million compared to $21.0 million for the year ended December 31, 2024.
The decrease of $1.8 million was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, personnel related expenses, and stock-based compensation expense, partially offset by increases in expenses related to clinical trials for the Co-Dx PCR platform and professional services expense.
During the year ended December 31, 2025, the Company recognized impairment charges of $18.9 million related to in-process research and development intangible assets recorded in conjunction with the acquisitions of Idaho Molecular, Inc. and Advanced Conceptions, Inc. in 2021.
Other Income Other income was $1.7 million for the year ended December 31, 2025, compared to other income of $2.5 million for the year ended December 31, 2024.
The decrease in other income of $0.8 million was primarily due to decreases in interest income and realized gains from investments in marketable securities.
Net Loss We realized a net loss for the year ended December 31, 2025 of $46.9 million compared to $37.6 million for the year ended December 31, 2024.
The larger net loss of $9.3 million was primarily the result of the recognition of intangible asset impairment charges and decreases in grant revenues, partially offset by decreases in operating expenses.
Additionally, we recorded an income tax benefit of $1.6 million during the year ended December 31, 2025, compared to an income tax expense of $0.1 million for the year ended December 31, 2024.
The current year income tax benefit relates primarily to new United States tax legislation which was signed into law during 2025 which resulted in the Company being eligible for certain federal and state tax refunds related to prior years.
LIQUIDITY AND CAPITAL RESOURCES At December 31, 2025, we had cash and cash equivalents of $11.9 million.
Additionally, our total current assets at December 31, 2025, were $13.7 million compared to total current liabilities of $3.5 million.
Net cash used in operating activities during the year ended December 31, 2025 was $29.1 million, compared to net cash used in operating activities of $29.2 million for the year ended December 31, 2024.
The slight decrease in cash used in operating activities was primarily due to lower operating expenses, primarily legal expenses, offset by decreases in grant revenue, net interest income, and realized gains on investments.
Net cash provided by investing activities was $26.3 million for the year ended December 31, 2025, compared to net cash provided by investing activities of $17.1 million during the year ended December 31, 2024.

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Gone since FY2024

Business Overview Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including robust and innovative molecular tools for detection of infectious diseases.
CODX’s technical advance involves a novel, proprietary approach to PCR test design of primer and probe structure (“Co-Primers ® ”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA.
We are currently developing a unique, groundbreaking portable diagnostic device and test system designed for point-of-care and at-home use.
In June 2024, we completed our first U.S.
Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use.
Following productive engagement with the FDA related to the regulatory submission, the Company withdrew its 510(k) application.
The decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability.
Following dialogue with the FDA and exploring the various courses of action available, we determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.
The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance.
A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which the Company believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care Co-Dx PCR platform.
Our Logix Smart ® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic or IVD in countries that accept CE marking for regulatory clearance in a period of just over 30 days.
Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins.
Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user needs.
Using our proprietary test design system and reagents, we have designed and obtained regulatory approval in the European Community and in India to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus.
In addition to testing for infectious disease, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications.
We, in conjunction with our customers, have designed and licensed tests that identify genetic traits in plant and animal genomes.
RESULTS OF OPERATIONS Results of Operations for the Years Ended December 31, 2024 and 2023 The table below provides a comparison of our operating results for the year ended December 31, 2024 as compared to the year ended December 31, 2023.
Years Ended December 31, Year Change 2024 2023 Change % Product revenue $ 770,048 $ 991,473 $ (221,425 ) -22 % Grant revenue 3,145,112 5,820,565 (2,675,453 ) -46 % Total revenue 3,915,160 6,812,038 (2,896,878 ) -43 % Cost of revenue 999,124 4,184,949 (3,185,825 ) -76 % Gross profit 2,916,036 2,627,089 288,947 11 % Operating expenses Sales and marketing 4,483,339 6,860,815 (2,377,476 ) -35 % General and administrative 16,157,152 14,279,441 1,877,711 13 % Research and development 20,979,589 22,962,593 (1,983,004 ) -9 % Depreciation and amortization 1,377,266 1,230,474 146,792 12 % Total operating expenses 42,997,346 45,333,323 (2,335,977 ) -5 % Loss from operations (40,081,310 ) (42,706,234 ) 2,624,924 -6 % Other income Interest income, net 1,091,825 1,161,913 (70,088 ) -6 % Realized gain on investments 870,745 2,243,059 (1,372,314 ) -61 % Gain (loss) on disposition of assets 8,291 (2,578 ) 10,869 -422 % Gain on remeasurement of acquisition contingencies 714,876 1,092,581 (377,705 ) -35 % Gain (loss) on equity method investment in joint venture (186,067 ) 100,703 (286,770 ) -285 % Total other income, net 2,499,670 4,595,678 (2,096,008 ) -46 % Loss before income taxes (37,581,640 ) (38,110,556 ) 528,916 -1 % Income tax provision (benefit) 57,368 (2,777,691 ) 2,835,059 -102 % Net loss $ (37,639,008 ) $ (35,332,865 ) $ (2,306,143 ) 7 % Revenues For the year ended December 31, 2024, we generated $3.9 million of revenue compared to revenue of $6.8 million in the year ended December 31, 2023.
The decrease in revenue of $2.9 million was primarily due to lower grant revenues, as the majority of revenue for grants previously awarded was recognized in the prior year.
Cost of Revenues and Gross Profit Cost of revenues decreased by $3.2 million from $4.2 million for the year ended December 31, 2023 to $1.0 million for the year ended December 31, 2024.
Included within cost of revenues is a decrease of approximately $0.1 million for the year ended December 31, 2024, and an increase of approximately $2.8 million for the year ended December 31, 2023, related to reserves against certain raw materials and finished goods inventories.
Operating Expenses Total operating expenses were $43.0 million for the year ended December 31, 2024 compared to total operating expenses of $45.3 million for the year ended December 31, 2023.
The decrease in operating expenses was primarily due to decreased stock-based compensation expense, bad debt expense and expense related to development of and clinical trials for the Co-Dx PCR platform.
These decreases were partially offset by increased personnel related and legal expenses.
Sales and marketing expenses for the year ended December 31, 2024 were $4.5 million compared to $6.9 million for the year ended December 31, 2023.
The decrease of $2.4 million was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses.
General and administrative expenses for the year ended December 31, 2024 were $16.2 million compared to $14.3 million for the year ended December 31, 2023.
The increase of $1.9 million was primarily due to increased legal expenses, partially offset by decreases in stock-based compensation expense, bad debt expense, consulting and professional services expense, and insurance expense.
Research and development expenses for the year ended December 31, 2024 were $21.0 million compared to $23.0 million for the year ended December 31, 2023.
The decrease of $2.0 million was primarily a result of decreased expenses related to development of and clinical trials for the Co-Dx PCR platform and stock-based compensation expense, partially offset by increases in personnel expense and professional services expense.
Other Income Other income was $2.5 million for the year ended December 31, 2024, compared to other income of $4.6 million for the year ended December 31, 2023.
The decrease in other income of $2.1 million was primarily due to a change in the fair value of contingent consideration liabilities, an increased loss related to the Company’s joint venture investment, and decreased realized gains from investments in marketable securities.
Net Loss We realized a net loss for the year ended December 31, 2024 of $37.6 million compared to $35.3 million for the year ended December 31, 2023.
The larger net loss of $2.3 million was primarily the result of decreases in grant revenue, changes in the fair value of acquisition contingencies, and decreases in realized gains from investments in marketable securities, partially offset by a decrease in operating expenses.
Additionally, we recorded income tax expense of $0.1 million during the year ended December 31, 2024, compared to an income tax benefit of $2.8 million for the year ended December 31, 2023.
The primary reason for the change in the provision for income taxes is a result of the Company now recording a full valuation allowance.
LIQUIDITY AND CAPITAL RESOURCES At December 31, 2024, we had cash and cash equivalents of $2.9 million and marketable investment securities of $26.8 million.
We consider our marketable investment securities an important part of our liquidity and focus such investments in securities that can readily be converted into cash if needed.
Additionally, our total current assets at December 31, 2024, were $32.3 million compared to total current liabilities of $7.3 million.
Net cash used in operating activities during the year ended December 31, 2024 was $29.2 million, compared to net cash used in operating activities of $22.1 million for the year ended December 31, 2023.

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