Item 9A. Controls and Procedures
ITEM 9A. Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures .
The Company’s management, with the participation of the Company’s Chief Executive Officer (CEO), Chief Financial Officer (CFO) and Chief Accounting Officer (CAO), has evaluated the effectiveness of the Company’s disclosure controls
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and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2025. Based on that evaluation, the Company’s management, including such officers, concluded that as of December 31, 2025 the Company’s disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including the Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer, to allow timely decisions regarding required disclosure and is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.
(b) Management’s Report on Internal Control Over Financial Reporting.
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. Under the supervision and with the participation of the Company’s management, including the Company's principal executive officer and principal financial officer, the Company conducted an evaluation of the effectiveness of its internal control over financial reporting based on the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on the Company's evaluation under the framework, management concluded that the Company's internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles as of December 31, 2025.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
The effectiveness of the Company's internal control over financial reporting as of December 31, 2025 has been audited by GRANT THORNTON LLP, an independent registered public accounting firm, as stated in their report, which is included below.
(c) Changes in Internal Control Over Financial Reporting .
There were no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
(d) Report of Independent Registered Public Accounting Firm .
Board of Directors and Stockholders
OraSure Technologies, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited the internal control over financial reporting of OraSure Technologies, Inc. (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2025, based on criteria established in the 2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on criteria established in the 2013 Internal Control—Integrated Framework issued by COSO.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated financial statements of the Company as of and for the year ended December 31, 2025, and our report dated March 9, 2026 expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
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We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ GRANT THORNTON LLP
Philadelphia, Pennsylvania
March 9, 2026
ITEM 9B. Other Information.
a. None.
b. The following table discloses any director or “officer” as defined in Rule 16a-1(f) under the Exchange Act who adopted or terminated any Rule 10b5-1 trading plan or arrangements or any non-Rule 10b5-1 trading plan or arrangements, in both cases as defined in Item 408(a) of Regulation S-K during the fourth quarter of the fiscal year ended December 31, 2025.
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Name and Title Action Taken (Date of Action) Type of Trading Arrangement Nature of Trading Arrangement Duration or End Date Aggregate Number of Securities
Carrie Eglinton Manner President, Chief Executive Officer and Director
Adoption (November 29, 2025) Trading plan intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c). Purchase of the Company’s common stock pursuant to the terms of the plan. Active through August 28, 2026 Up to $165,000 of shares of the Company’s common stock
Kenneth McGrath
Chief Financial Officer
Adoption (November 28, 2025) Trading plan intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c). Purchase of the Company’s common stock pursuant to the terms of the plan. Active through August 28, 2026 Up to $165,000 of shares of the Company’s common stock
Other than as disclosed above, no other director or officer adopted or terminated any Rule 10b5-1 trading plan or arrangements or any non-Rule 10b5-1 trading plan or arrangements, in both cases as defined in Item 408(a) of Regulation S-K during the fourth quarter of the fiscal year ended December 31, 2025 .
ITEM 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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PART III
The Company has omitted from Part III the information that will appear in its Definitive Proxy Statement for its 2026 Annual Meeting of Stockholders (the “2026 Proxy Statement”), which will be filed within 120 days after the end of its fiscal year pursuant to Regulation 14A.
ITEM 10. Directors, Executive Officers and Corporate Governance.
The information required by this Item 10 will be included in the Company's 2026 Proxy Statement and is incorporated herein by reference.
Code of Conduct
The Board of Directors has adopted a Code of Business Conduct and Ethics that applies to the Company's principal executive officer, principal financial officer and principal accounting officer, as well as to the members of its Board of Directors and its other officers and employees. This Code of Business Conduct and Ethics is available on the Company's website at www.orasure.com . The Company intends to satisfy the amendment and waiver disclosure requirements under applicable securities regulations by posting any amendments of, or waivers to, the Code of Business Conduct and Ethics on its website.
Insider Trading Arrangements and Policies
The Board of Directors has adopted insider trading policies and procedures governing the purchase, sale, and other dispositions of securities of OraSure by directors, officers, and employees that the Company believes are reasonably designed to promote compliance with insider trading laws, rules and regulations, and applicable Nasdaq listing standards. The Company’s insider trading policy states, among other things, that its directors, officers, and employees are prohibited from trading in such securities while in possession of material, nonpublic information. In addition, with regard to trading in the Company’s own securities, it is the Company’s policy to comply with the federal securities laws and the applicable exchange listing requirements. The foregoing summary of the Company’s insider trading policies and procedures does not purport to be complete and is qualified by reference to the insider trading policy attached hereto as Exhibit 19.1 and incorporated herein.
ITEM 11. Executive Compensation.
The information required by this Item 11 will be included in the Company's 2026 Proxy Statement and is incorporated herein by reference.
ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item 12 will be included in the Company's 2026 Proxy Statement and is incorporated herein by reference.
ITEM 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item 13 will be included in the Company's 2026 Proxy Statement and is incorporated herein by reference.
ITEM 14. Principal Accountant Fees and Services.
The information required by this Item 14 will be included in the Company's 2026 Proxy Statement and is incorporated herein by reference.
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PART IV
ITEM 15. Exhibits and Consolidated Financial Statement Schedules.
(a)(1) and (a)(2). Consolidated Financial Statements and Schedules . For a list of the consolidated financial statements filed herewith, see the Index to Consolidated Financial Statements following the signature page to this Annual Report. No schedules are included with the consolidated financial statements because the required information is inapplicable or is presented in the consolidated financial statements or related notes thereto.
(a)(3). Exhibits .
Exhibit
Number Exhibit
2.1†●
Agreement and Plan of Merger, dated December 19, 2024 by and among OraSure Technologies, Inc., Project Watson Merger Sub, Inc., Sherlock Biosciences, Inc. and Mr. Paul Meister, solely in his capacity as representative of the securityholders of Sherlock Biosciences, Inc. is incorporated by reference to Exhibit 2.1 to the Company’s Annual Report on form 10-K for the year ended December 31, 2024.
3.1.1 Certificate of Incorporation of OraSure Technologies, Inc. is incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-4 (No. 333-39210), filed June 14, 2000.
3.1.2 Certificate of Amendment to Certificate of Incorporation dated May 23, 2000 is incorporated by reference to Exhibit 3.1.1 to the Company’s Registration Statement on Form S-4 (No. 333-39210), filed June 14, 2000.
3.1.3 Certificate of Amendment to Certificate of Incorporation of OraSure Technologies Inc. dated May 16, 2024 is incorporated by reference to Exhibit 3.1 to the Company’s Periodic Report on Form 8-K filed on May 17, 2024.
3.2 Third Amended and Restated Bylaws of OraSure Technologies, effective as of Au gust 5, 2025 , is incorporated by referenced to Exhibit 3. 2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.
4.1 Description of Securities is incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the year-ended December 31, 2019 .
10.1 Employment Agreement, dated as of January 1, 2019, between Kathleen G. Weber, DNA Genotek, Inc. and OraSure Technologies, Inc. is incorporated by reference to Exhibit 10.21 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.*
10.2 Amendment No. 1 to Employment Agreement, dated as of December 20, 2021, between Kathleen G. Weber, DNA Genotek, Inc. and OraSure Technologies, Inc. is incorporated by reference to exhibit 10.10 to the Company's Annual Report on form 10-K for the year ended December 31, 2021*
10.3 Amendment No. 2 to Employment Agreement, dated as of November 7, 2022, between Kathleen G. Weber, DNA Genotek, Inc. and OraSure Technologies, Inc. is incorporated by reference to Exhibit 10.5 of the Company's Annual Report on form 10-K for the year ended December 31, 2022*
10.4 Employment Agreement, dated as of May 20, 2022, between OraSure Technologies, Inc. and Carrie Eglinton-Manner is incorporated by reference to exhibit 10.1 to the company's Current Report on Form 8-K filed on May 26, 2022. *
10.5 Employment Agreement dated August 8, 2022, between OraSure Technologies, Inc. and Kenneth J. McGrath is incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on August 12, 2022.*
10.6 Severance Letter Agreement, dated August 25, 2021, between OraSure Technologies, Inc. and Michele M. Miller is incorporated by reference to Exhibit 10.13 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021.*
10.7 Description of Non-Employee Director Compensation Policy, as amended, is incorporated by reference to Item 5.02 to the Company’s Current Report on form 8-K filed August 14, 2019.*
10.8 Amended and Restated Epitope, Inc. 1991 Stock Award Plan is incorporated by reference to Exhibit 10.9 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2002.*
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10.90 OraSure Technologies, Inc. Employee Incentive and Non-Qualified Stock Option Plan, as amended and restated effective September 29, 2000, is incorporated by reference to Exhibit 10.12 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2000.*
10.10 Amended and Restated OraSure Technologies, Inc. Stock Award Plan, effective April 4, 2020, is incorporated by reference to Exhibit A to the Company’s Proxy Statement, filed April 9, 2020, for the 2020 Annual Meeting of Stockholders.*
10.11 Amended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan, Effective March 31, 2023, is incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed May 16, 2023.*
10.12 Amended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan, Effective March 25, 2024, is incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed May 17, 2024.*
10.13 Amended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan, Effective March 2 4 , 2025, is incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed May 14, 2025. *
10.14 Form of Restricted Share Award Agreement (Executive Officers – Employment Agreements) is incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.*
10.15 Form of Restricted Unit Award Agreement (Executive Officers – Employment Agreements) is incorporated by reference to Exhibit 10.27 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. *
10.16 Form of Restricted Unit Award Agreement (Executive Officers-Employment Agreements) for 2021 awards is incorporated by reference to Exhibit 10.20 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021.*
10.17 Form of Restricted Share Grant Agreement (Non-Employee Directors) is incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.*
10.18 Nonqualified Stock Option Award General Terms and Conditions (Executive Officers) is incorporated by reference to Exhibit 10.25 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.*
10.19 Nonqualified Stock Option Award General Terms and Conditions (Non-Employee Directors) is incorporated by reference to Exhibit 10.26 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.*
10.20 OraSure Technologies, Inc. Deferred Compensation Plan is incorporated by reference to Exhibit 99.1 to the Company’s Current Report on Form 8-K filed December 21, 2011.*
10.21 Adoption Agreement related to OraSure Technologies, Inc. Deferred Compensation Plan is incorporated by reference to Exhibit 99.2 to the Company’s Current Report on Form 8-K filed December 21, 2011.*
10.22 $109 Million Capital Funding Agreement with the U.S. Department of Defense, in coordination with the Department of Health and Human Services is incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on From 10-Q for the period ended September 30, 2021, filed November 4, 2021.
10.23 Industrial Lease between Core5 at Laughman Farms Phase 1, LLC as Landlord and OraSure Technologies, Inc. as Tenant, dated January 3, 2022 is incorporated by reference to Exhibit 10.30 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021.
19.1+ Insider Trading Policy
21.1+ Subsidiaries of the Company
23.1 +
Consent of KPMG LLP.
23.2+ Consent of Grant Thornton LLP
24.1 +
Powers of Attorney.
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31.1 +
Certification of Carrie Eglinton Manner. required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
31.2 +
Certification of Kenneth J. McGrath required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
32.1^ Certification of Carrie Eglinton Manner. required by Rule 13a-14(b) or Rule 15a-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2^ Certification of Kenneth J. McGrath required by Rule 13a-14(b) or Rule 15a-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 .
97.10 OraSure Technologies Inc. Compensation Recovery Policy is incorporated by reference to Exhibit 97.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 2023.
101.INS Inline XBRL Instance Document
101.SCH Inline XBRL Taxonomy Extension Schema Document
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase document
104 The cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, has been formatted in Inline XBRL.
________________________________________________
+ Filed herewith.
^ This certification is deemed not filed for purposes of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filings under the Securities Act or the Exchange Act.
* Management contract or compensatory plan or arrangement.
† Certain portions of this Exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The Company hereby agrees to furnish supplementally an unredacted copy of the exhibit to the SEC upon its request.
● Certain schedules, annexes or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K, but will be furnished supplementally to the SEC upon request.
ITEM 16. Form 10-K Summary.
None
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on March 9, 2026.
ORASURE TECHNOLOGIES, INC.
By: /s/ Carrie Eglinton Manner
Carrie Eglinton Manner
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed on March 9, 2026, by the following persons on behalf of the Registrant and in the capacities indicated.
SIGNATURE TITLE
/s/ Carrie Eglinton Manner President, Chief Executive Officer and Director
(Principal Executive Officer)
Carrie Eglinton Manner
/s/ Kenneth J. McGrath Chief Financial Officer
(Principal Financial Officer)
Kenneth J. McGrath
/s/ Michele Anthony Senior Vice President, Controller & Chief Accounting Officer
(Principal Accounting Officer)
Michele Anthony
*STEVEN K. BOYD Director
Steven K. Boyd
*NANCY J. GAGLIANO, M.D. Director
Nancy J. Gagliano, M.D.
*JOHN P. KENNY Director
John P. Kenny
*LELIO MARMORA Director
Lelio Marmora
*ROBERT W. MCMAHON Director
Robert W. McMahon
*By: /s/Stefano Taucer
Stefano Taucer
(Attorney-in-Fact)
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Index to Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm ( GRANT THORNTON LLP , Philadelphia, PA , Auditor Firm ID: 248 )
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Report of Independent Registered Public Accounting Firm (KPMG LLP, Philadelphia, PA, Auditor Firm ID: 185)
F-4
Consolidated Balance Sheets
F- 5
Consolidated Statements of Operations
F- 6
Consolidated Statements of Comprehensive Income (Loss)
F- 7
Consolidated Statements of Stockholders’ Equity
F- 8
Consolidated Statements of Cash Flows
F- 9
Notes to the Consolidated Financial Statements
F- 10
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
OraSure Technologies, Inc.
Opinion on the financial statements
We have audited the accompanying consolidated balance sheets of OraSure Technologies, Inc. (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive (loss) income, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in the 2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”), and our report dated March 9, 2026 expressed an unqualified opinion.
Basis for opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical audit matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Fair value of the royalty based contingent consideration from the Sherlock Biosciences, Inc. acquisition
As further described in Notes 2 and 13 to the consolidated financial statements, on December 19, 2024, the Company acquired Sherlock Biosciences, Inc. ("Sherlock"), pursuant to the terms of a merger agreement. The purchase consideration transferred in this transaction included, in part, contingent consideration related to royalty payments through December 31, 2034, representing a mid-single digit percentage of future revenues associated with the acquired in-process research and development technology intangible asset. The royalty based contingent consideration is adjusted to fair value at each reporting period. The estimated fair value of the royalty based contingent consideration as of December 31, 2025 was $9.1 million. We identified the fair value determinations of the royalty based contingent consideration as a critical audit matter.
The principal consideration for our determination that the fair value of the royalty based contingent consideration is a critical audit matter is that the inputs and assumptions utilized by management require significant judgment and result in a high degree of estimation uncertainty. The subjectivity of the estimate increases the level of auditor judgment and effort to
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evaluate management’s significant assumptions, including (i) future expected revenues and (ii) discount rates. Further, changes in these assumptions and judgments could have a significant impact on the recorded fair value.
Our audit procedures related to the fair value of the royalty based contingent consideration included the following, among others:
• Evaluated the design and operating effectiveness of key controls related to management’s processes over the development of the fair value estimates and related key inputs and assumptions, and over the evaluation of the competency and objectivity of management's third-party valuation specialist.
• Tested the mathematical accuracy of the valuation models utilized and the completeness, accuracy and relevance of underlying data used in the model.
• Assessed the reasonableness of management’s estimated revenues by obtaining an understanding of management’s processes for developing projected financial information, including inspection of relevant market data and other supporting documentation.
• Utilized valuation specialists to evaluate the reasonableness of the methodology and discount rates used in the valuation.
• Conducted sensitivity analyses around the future expected revenues and discount rate assumptions utilized by management.
/s/ GRANT THORNTON LLP
We have served as the Company’s auditor since 2023.
Philadelphia, Pennsylvania
March 9, 2026
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Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
OraSure Technologies, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated statements of operations, comprehensive (loss) income, stockholders’ equity, and cash flows of OraSure Technologies, Inc. and subsidiaries (the Company) for the year ended December 31, 2023, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the results of operations of the Company and its cash flows for the year ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ KPMG LLP
We served as the Company’s auditor from 2002 to 2024.
Philadelphia, Pennsylvania
March 11, 2024, except for Note 12, as to which the date is March 7, 2025
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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
December 31, 2025 December 31, 2024
ASSETS
Current Assets:
Cash and cash equivalents $ 199,278 $ 267,763
Accounts receivable, net of allowance for doubtful accounts of $ 188 and $ 774
22,203 23,816
Inventories 31,060 34,197
Prepaid expenses 5,221 3,956
Other current assets 4,146 3,488
Total current assets 261,908 333,220
Noncurrent Assets:
Property, plant and equipment, net of accumulated depreciation 39,179 45,105
Operating right-of-use assets, net 11,996 13,442
Finance right-of-use assets, net 146 145
Intangible assets, net of accumulated amortization 19,046 17,435
Goodwill 43,363 40,330
Investment in equity method investee 25,956 28,300
Deferred tax asset 271 156
Other noncurrent assets 1,303 1,526
Total noncurrent assets 141,260 146,439
TOTAL ASSETS $ 403,168 $ 479,659
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 6,521 $ 8,173
Deferred revenue 1,518 2,961
Accrued expenses and other current liabilities 11,149 20,179
Finance lease liability 63 41
Operating lease liability 2,164 2,129
Acquisition-related contingent consideration obligation 18,380 —
Total current liabilities 39,795 33,483
Noncurrent Liabilities:
Finance lease liability 100 113
Operating lease liability 10,870 12,321
Acquisition-related contingent consideration obligation 9,333 22,910
Other noncurrent liabilities 2,243 494
Total noncurrent liabilities 22,546 35,838
TOTAL LIABILITIES 62,341 69,321
Commitments and contingencies (Note 14)
STOCKHOLDERS' EQUITY
Preferred stock, par value $ 0.000001 , 25,000 shares authorized, none issued
— —
Common stock, par value $ 0.000001 , 120,000 shares authorized, 70,391 and 74,598 shares issued and outstanding
— —
Additional paid-in capital 531,393 538,129
Accumulated other comprehensive loss ( 18,404 ) ( 24,360 )
Accumulated deficit ( 172,162 ) ( 103,431 )
Total stockholders' equity 340,827 410,338
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 403,168 $ 479,659
See accompanying notes to the consolidated financial statements.
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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
For the Years Ended December 31,
2025 2024 2023
NET REVENUES:
Products and services $ 109,055 $ 184,611 $ 402,222
Other 5,966 1,216 3,250
115,021 185,827 405,472
COST OF PRODUCTS AND SERVICES SOLD 66,823 106,437 233,820
Gross profit 48,198 79,390 171,652
OPERATING EXPENSES:
Research and development 42,528 26,047 33,728
Sales and marketing 26,117 30,986 36,319
General and administrative 47,677 46,215 58,191
Loss on impairments — 4,392 10,829
Change in the estimated fair value of acquisition-related contingent consideration 4,570 — ( 99 )
Gain on sale of assets ( 725 ) — —
120,167 107,640 138,968
Operating (loss) income ( 71,969 ) ( 28,250 ) 32,684
OTHER INCOME 7,383 12,249 23,574
(Loss) income before income taxes and equity investment ( 64,586 ) ( 16,001 ) 56,258
INCOME TAX EXPENSE 1,801 1,799 2,603
(LOSS) INCOME BEFORE EQUITY INVESTMENT ( 66,387 ) ( 17,800 ) 53,655
LOSS ON EQUITY INVESTMENT ( 2,344 ) ( 1,700 ) —
NET (LOSS) INCOME $ ( 68,731 ) $ ( 19,500 ) $ 53,655
(LOSS) INCOME PER SHARE:
BASIC $ ( 0.94 ) $ ( 0.26 ) $ 0.73
DILUTED $ ( 0.94 ) $ ( 0.26 ) $ 0.72
SHARES USED IN COMPUTING (LOSS) INCOME PER SHARE:
BASIC 73,485 74,434 73,348
DILUTED 73,485 74,434 74,389
See accompanying notes to the consolidated financial statements.
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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(in thousands)
For the Years Ended December 31,
2025 2024 2023
NET (LOSS) INCOME $ ( 68,731 ) $ ( 19,500 ) $ 53,655
OTHER COMPREHENSIVE INCOME (LOSS)
Currency translation adjustments 5,956 ( 9,419 ) 3,274
Unrealized gain on marketable securities — — 220
COMPREHENSIVE (LOSS) INCOME $ ( 62,775 ) $ ( 28,919 ) $ 57,149
See accompanying notes to the consolidated financial statements.
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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For the Years Ended December 31, 2025, 2024 and 2023
(in thousands)
Common Stock Additional
Paid-in
Capital Accumulated
Other
Comprehensive
Loss Accumulated
Deficit Total
Shares Amount
Balance at January 1, 2023 72,734 $ — $ 520,446 $ ( 18,435 ) $ ( 137,586 ) $ 364,425
Common stock issued upon exercise of options 44 — 269 — — 269
Vesting of restricted stock and performance stock units 1,098 — — — — —
Purchase and retirement of common shares ( 348 ) — ( 1,901 ) — — ( 1,901 )
Stock-based compensation — — 10,729 — — 10,729
Net income — — — — 53,655 53,655
Currency translation adjustments — — — 3,274 — 3,274
Unrealized gain on marketable securities — — — 220 — 220
Balance at December 31, 2023 73,528 $ — $ 529,543 $ ( 14,941 ) $ ( 83,931 ) $ 430,671
Common stock issued upon exercise of options 32 — 214 — — 214
Vesting of restricted stock and performance stock units 1,678 — — — — —
Purchase and retirement of common shares ( 640 ) — ( 3,548 ) — — ( 3,548 )
Stock-based compensation — — 11,920 — — 11,920
Net loss — — — — ( 19,500 ) ( 19,500 )
Currency translation adjustments — — — ( 9,419 ) — ( 9,419 )
Balance at December 31, 2024 74,598 $ — $ 538,129 $ ( 24,360 ) $ ( 103,431 ) $ 410,338
Shares repurchased and retired in satisfaction of minimum tax withholding for vested restricted stock and performance stock units 1,640 — — — — —
Purchase and retirement of common shares ( 564 ) — ( 1,843 ) — — ( 1,843 )
Stock-based compensation — — 10,147 — — 10,147
Shares repurchased and retired in connection with share repurchase program ( 5,283 ) — ( 15,040 ) — — ( 15,040 )
Net loss — — — — ( 68,731 ) ( 68,731 )
Currency translation adjustments — — — 5,956 — 5,956
Balance at December 31, 2025 70,391 $ — $ 531,393 $ ( 18,404 ) $ ( 172,162 ) $ 340,827
See accompanying notes to the consolidated financial statements.
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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
For the Years Ended December 31,
2025 2024 2023
OPERATING ACTIVITIES:
Net (loss) income $ ( 68,731 ) $ ( 19,500 ) $ 53,655
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities
Stock-based compensation 10,147 11,920 10,729
Depreciation and amortization 10,192 10,872 20,936
Loss on impairments — 4,392 10,829
Other non-cash amortization ( 222 ) ( 564 ) 3
Provision for credit losses ( 65 ) 71 ( 462 )
Unrealized foreign currency loss (gain) 365 ( 263 ) 103
Interest expense on finance leases 8 22 51
Loss on equity investment 2,344 1,700 —
Deferred income taxes 1,853 ( 657 ) 102
(Gain) loss on sale of fixed assets ( 725 ) 563 —
Change in the estimated fair value of acquisition-related contingent consideration 4,570 — ( 99 )
Payment of acquisition-related contingent consideration — — ( 19 )
Changes in assets and liabilities:
Accounts receivable 1,949 15,872 31,116
Inventories 3,562 13,096 48,228
Prepaid expenses and other assets ( 2,368 ) 4,089 ( 2,499 )
Accounts payable ( 1,720 ) ( 7,577 ) ( 26,976 )
Deferred revenue ( 1,519 ) ( 219 ) ( 730 )
Accrued expenses and other liabilities ( 8,663 ) ( 6,443 ) ( 3,384 )
Net cash (used in) provided by operating activities ( 49,023 ) 27,374 141,583
INVESTING ACTIVITIES:
Purchases of short-term investments — ( 53,244 ) ( 74,652 )
Proceeds from maturities and redemptions of investments — 53,052 102,440
Purchase of equity method investee — ( 30,000 ) —
Acquisition of business, net of cash acquired ( 3,613 ) ( 5,037 ) —
Proceeds from sale of assets 1,000 — —
Purchases of property and equipment ( 4,197 ) ( 3,797 ) ( 5,802 )
Purchase of property and equipment under government contracts — — ( 4,501 )
Proceeds from funding under government contracts — — 48,669
Net cash (used in) provided by investing activities ( 6,810 ) ( 39,026 ) 66,154
FINANCING ACTIVITIES:
Cash payments for lease liabilities ( 61 ) ( 842 ) ( 1,345 )
Proceeds from exercise of stock options — 214 269
Repurchase of common stock ( 15,040 ) — —
Payment of acquisition-related contingent consideration — — ( 46 )
Payment of taxes related to net share settlement of equity awards ( 1,843 ) ( 3,548 ) ( 1,901 )
Net cash used in financing activities ( 16,944 ) ( 4,176 ) ( 3,023 )
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH 4,292 ( 6,816 ) 1,713
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS ( 68,485 ) ( 22,644 ) 206,427
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 267,763 290,407 83,980
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 199,278 $ 267,763 $ 290,407
See accompanying notes to the consolidated financial statements.
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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(all tabular amounts in thousands)
1. THE COMPANY:
OraSure Technologies transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across two segments, being the “Diagnostics” segment and the “Molecular Solutions” segment, into one business unit with sales, marketing, product development, and research teams covering multiple product lines. This change is intended to accelerate innovation, enhance customer experience and result in operational synergies. As a result, all products and services reside under one reporting hierarchy.
The Company's product portfolio is broadly divided into diagnostics products and sample management solutions. The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use specimen collection devices and diagnostic products designed to detect certain infectious diseases including HIV, Hepatitis C, Syphilis and Sickle Cell that are performed on a rapid basis at the point of care. The Company's business also includes sample management solutions and molecular services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. During 2024, the Company exited the molecular services business. In October 2024, the Company announced the discontinuance of the sales of its risk assessment product line which was completed in the first half of 2025.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Principles of Consolidation and Basis of Presentation
The consolidated financial statements include the accounts of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned subsidiaries, DNA Genotek Inc. ("DNAG"), Diversigen, Inc. ("Diversigen"), Novosanis NV ("Novosanis"), BioMedomics, Inc. ("BioMedomics") and Sherlock Biosciences, Inc. ("Sherlock"). Novosanis was legally dissolved in June 2025. All intercompany transactions and balances have been eliminated. References herein to “we”, “us”, “our”, or the “Company” mean OraSure and its consolidated subsidiaries, unless otherwise indicated.
Change in Accounting Principle
Effective January 1, 2025, the Company changed its methodology for valuing certain inventories to the average cost method from the first-in, first-out ("FIFO") cost method. The change was applicable to all inventories. The Company concluded that the average cost basis of accounting is preferable as it results in greater precision in the calculation of acquisition cost of inventory on the balance sheet. The effect of this change in accounting principle was immaterial. Therefore, retroactive application was not determined to be necessary and a cumulative adjustment of $ 0.1 million was recorded in the statement of operations for the twelve months ended December 31, 2025.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions about future events. These estimates and underlying assumptions affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenues and expenses. Such estimates include the fair value of assets acquired and liabilities assumed for business combinations, the valuation of accounts receivable and inventories and assumptions utilized in impairment testing for property, plant and equipment, intangible assets and goodwill, as well as estimates related to accruals, taxes, contingent consideration, and performance-based compensation expense. These estimates and assumptions are based on management’s best estimates and judgment. Management evaluates its estimates and assumptions on an ongoing basis, using historical experience and other factors, which management believes to be reasonable under the circumstances, including the current economic environment. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Changes in those estimates resulting from continuing changes in the economic environment and other factors will be reflected in the financial statements in those future periods.
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Supplemental Cash Flow Information
The Company paid income taxes of $ 1.8 million and $ 1.8 million in 2025 and 2024, respectively, and received income tax refunds of $ 4.9 million in 2023.
The Company had account receivable write-offs of $ 0.5 million, $ 0.5 million, and $ 0.7 million in 2025, 2024, and 2023, respectively.
As of December 31, 2025, 2024 and 2023, the Company had accruals for purchases of property and equipment of $ 0.5 million, $ 0.5 million and $ 0.2 million, respectively.
The Company acquired BioMedomics which included contingent consideration of $ 0.3 million for the year ended December 31, 2025.
The Company acquired Sherlock which included contingent consideration of $ 22.9 million for the year ended December 31, 2024.
Cash Equivalents & Short-Term Investments
The Company considers all investments in debt securities to be available-for-sale securities. These securities consist of guaranteed investment certificates purchased with maturities greater than ninety days. Securities with maturities ninety days or less are considered cash equivalents. Available-for-sale securities are carried at fair value, based upon quoted market prices, with unrealized gains and losses, if any, reported in stockholders’ equity as a component of accumulated other comprehensive loss.
The Company records an allowance for credit loss for the Company's available-for-sale securities when a decline in investment market value is due to credit-related factors. When evaluating an investment for impairment, the Company reviews factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments will continue to be made.
The Company had no available-for-sale securities as of December 31, 2025 and December 31, 2024.
The Company maintains cash balances in the United States in excess of the federally insured limits. The Company periodically evaluates financial institutions and believes the risk of loss to be remote due to this evaluation.
Fair Value of Financial Instruments
As of December 31, 2025 and 2024, the carrying values of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their respective fair values based on their short-term nature.
Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
To the extent that valuation is based on models or inputs that are unobservable in the market, determining fair value requires more judgment. Because of the inherent uncertainty of valuation, estimated values may be materially higher or lower than the values that would have been used had a ready market for the investments existed. Therefore, the degree of judgment exercised in determining fair value is greatest for assets or liabilities categorized in Level 3.
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December 31, December 31,
Level 2025 2024
Guaranteed investment certificates 1 $ 13,114 $ 66,584
Trading securities 1 543 724
Contingent consideration: 3
Current portion $ 18,380 $ —
Long-term portion 9,333 22,910
$ 27,713 $ 22,910
Included in cash and cash equivalents at December 31, 2025 and 2024 was $ 13.1 million and $ 66.6 million, respectively, invested in guaranteed investment certificates.
Included in cash and cash equivalents at December 31, 2025 and 2024, was $ 68.4 million and $ 118.5 million, respectively, invested in government money market funds. These funds have investments in U.S. government securities and are measured as Level 1 instruments.
The Company offers a nonqualified deferred compensation plan for certain eligible employees and members of the Company's Board of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. Separate accounts are maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts. The assets of the plan are held in mutual funds and Company stock. The fair value of the plan assets as of December 31, 2025 and 2024 was $ 0.5 million and $ 0.7 million, respectively, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified as trading securities and measured as Level 1 instruments. The fair value of plan assets is included in both current assets and other noncurrent assets with the same amounts included in accrued expenses and other noncurrent liabilities in the accompanying consolidated balance sheets .
Contingent Consideration
As discussed further in Note 13, Business Combinations, the Company has identified its contingent consideration obligations as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations. The contingent consideration is comprised of three different tranches: milestone payments, royalty payments, and earnout payments. The significant quantitative unobservable inputs for the milestone payments are the discount rate and probability achievement of a milestone of a regulatory approval.
The fair value methodology for royalty payments is based on a discounted cash flow model. Significant quantitative unobservable inputs are internally developed future expected cash flows, discount rate and probability achievement of a milestone of a regulatory approval. The royalty payments represent a mid-single digit percentage of the net sales through 2034 associated with the acquired in-process and research and development intangible asset.
The fair value methodology for earnout payments is based on a Monte Carlo model. Significant quantitative unobservable inputs are future expected cash flows, discount rate and volatility rate.
There was an increase of $ 4.6 million in the fair value of the Company's contingent consideration from date of acquisition to December 31, 2025 for the milestone and royalty payments.
Fair Value
Balance at December 31, 2024 $ 22,910
Additions 233
Change in fair value 4,570
Balance at December 31, 2025 $ 27,713
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Equity Method Investee
In January 2024, the Company led the Series B financing and entered into wide-ranging strategic distribution agreements with KKR Sapphiros L.P. ("Sapphiros"), a privately held consumer diagnostic portfolio company, and certain of its related entities. Through this relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic tests and molecular sample management solutions to the Company's customers globally. As of December 31, 2025, the Company had funded $ 30.0 million for its interest in Sapphiros. The Company recorded the investment using the equity method in accordance with Accounting Standards Codification ("ASC") Topic 323, Investments—Equity Method and Joint Ventures—Overall. In accordance with the equity method, the Company's equity investment is presented net of its share of any gains or losses of the investee. The Company has elected as its accounting policy to recognize its share of any income or loss in Sapphiros on a three-month lag. The investment in Sapphiros of $ 26.0 million as of December 31, 2025 is included in the investment in equity method investee line of the Company's balance sheet. The Company has no unconditional obligations or guarantees to, or in support of, its equity method investee and its operations. In conjunction with the preparation of the Company's December 31, 2025 financial statements, the Company evaluated the investment in Sapphiros for impairment and concluded there was no such impairment. The Company's investment in Sapphiros was valued at $ 28.3 million as of December 31, 2024.
Related Party
The Company loaned Sapphiros $ 0.3 million during the year ended December 31, 2025. The loan plus interest is due in December 2026. During the year ended December 31, 2025, the Company entered into an agreement with Sapphiros to develop certain products for Sapphiros. A total of $ 0.2 million of revenue was recognized from this agreement.
Accounts Receivable
Accounts receivable has been reduced by an estimated allowance for amounts that may become uncollectible in the future. This estimated allowance is based primarily on management’s evaluation of specific balances as they become past due, the financial condition of the Company's customers and the Company's historical experience related to write-offs.
December 31,
2025 2024 2023
Accounts receivable $ 22,203 $ 23,816 $ 40,171
Allowance for doubtful accounts $ 188 $ 774 $ 1,216
Inventories
Inventories are stated at the lower of cost or net realizable value, with cost determined on an average cost method, and include the cost of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances. The Company continually evaluates quantities on hand and the carrying value of the Company's inventories to determine the need for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales. The Company reserves for inventory expiring within ninety days, with the exception of inventory that will be consumed or will have expiration dates extended. The Company also considers items identified through specific identification procedures in assessing the adequacy of the Company's reserve. Although the Company makes every effort to ensure the accuracy of expected changes in the business and of its forecasts of future product demand, any significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported operating results .
Property, Plant and Equipment
Property, plant and equipment are stated at cost. Additions or improvements are capitalized, while repairs and maintenance are charged to expense. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets as follows:
• buildings twenty years ;
• leasehold improvements, the lesser of the useful life of the improvement or the remaining life of the building or lease;
• computer equipment and software three years ;
• machinery and equipment five years ; and
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• furniture and fixtures seven years
When assets are sold, retired, or discarded, the related property amounts are relieved from the accounts, and any gain or loss is recorded in the consolidated statements of operations.
Intangible Assets
Intangible assets consist of customer relationships, patents and product rights, acquired technology, in-process research and development technology and trade names. Patents and product rights consist of costs associated with the acquisition of patents, licenses and product distribution rights. Intangible assets are amortized using the straight-line method over their estimated useful lives of five to fifteen years .
Impairment of Long-Lived Assets
Long-lived assets, which include property, plant and equipment and definite-lived intangible assets, are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the Company's long-lived assets by determining whether the carrying value of such assets can be recovered through the sum of the undiscounted future cash flows generated from the use and eventual disposition of the asset. If indicators of impairment exist, the Company measures the amount of such impairment by comparing the carrying value of the assets to the fair value of the assets, which is generally determined based on the present value of the expected future cash flows associated with the use of the assets. Expected future cash flows reflect the Company's assumptions about selling prices, volumes, costs and market conditions over a reasonable period of time. See Note 5 for discussion of property, plant and equipment impairments, recorded for the year ended December 31, 2024. See Note 6 for discussion of definite-lived intangible asset impairments, recorded for the year ended December 31, 2023.
Goodwill
Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. Goodwill is not amortized but rather is tested annually for impairment or more frequently if the Company believes that indicators of impairment exist. Current generally accepted accounting principles permit the Company to make a qualitative evaluation about the likelihood of goodwill impairment. If the Company concludes that it is more likely than not that the carrying value of a reporting unit is greater than its fair value, then the Company would be required to recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit.
The Company historically performed an annual goodwill impairment assessment as of July 31. During the three months ended December 31, 2023, the Company changed the date of the annual impairment assessment to November 30, to better align with the Company's annual forecasting process. On November 30, 2025, the Company performed a quantitative goodwill impairment test which concluded that the carrying value of the Company's goodwill for both the diagnostic and collection devices reporting units was below its fair value indicating there was no impairment.
As of November 30, 2025, the diagnostic reporting unit fair value exceeded its carrying value by 13 %. As of December 31, 2025, the diagnostic reporting unit had $ 8.2 million of goodwill. The diagnostic reporting unit goodwill impairment analysis used both an income and market approach. These two approaches were weighted and the income approach was weighed more than the market approach. Key assumptions included revenues increasing each year as products are launched and a weighted-average cost of capital based on guideline companies. The revenue and cashflows assumes products are passed by regulatory bodies on a set timeline and market competition of future products is low. The revenues assume market growth will accelerate each year. If there are delays to attaining regulatory approval or successfully launching products, this could have a negative outcome on the goodwill impairment analysis. In addition, if the Company's weighted-average cost of capital is not aligned with guideline companies, this could negatively affect the goodwill impairment outcome.
The below table illustrates the discount rate and exit multiple sensitivity to the fair value of the diagnostic reporting unit goodwill when performing the goodwill impairment analysis as of November 30, 2025. In the annual goodwill impairment analysis as of November 30, 2025, the diagnostic reporting unit utilized a 14% discount rate with an exit multiple of one.
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Exit Multiple
Discount Rate 0.80 0.90 1.00 1.10 1.20
13% $ 208,132 $ 217,464 $ 226,796 $ 236,128 $ 245,460
14% 205,252 214,254 223,256 232,258 241,259
15% 202,501 211,188 219,875 228,562 237,249
16% 199,868 208,254 216,640 225,025 233,411
17% 197,339 205,436 213,533 221,630 229,726
A more frequent evaluation is performed if an event occurs or circumstances change between annual tests that could more likely than not reduce the fair value of a reporting unit below its carrying amount.
Revenue
Product sales . Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.
The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of the Company's OraQuick ® HIV Self-Test to retail trade customers, and InteliSwab ® products to retail trade and certain other customers.
Historically, returns arising from warranty issues have been infrequent and immaterial. Accordingly, the Company expenses warranty returns as incurred.
The Company records shipping and handling charges billed to the Company's customers as product revenue and the related expense as cost of products sold.
Service revenues. Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues when the Company satisfies its performance obligations for services rendered. Service revenues are associated with the Diversigen business, which was discontinued in 2024. There were zero service revenues for the year ended December 31, 2025.
Arrangements with multiple performance obligations . In arrangements involving more than one performance obligation, which largely applies to the Company's service revenue stream, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on their respective relative stand-alone selling price. The estimated selling price of each performance obligation is determined using an observable cost plus margin approach. The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred for the related goods or services or when the performance obligation has been satisfied. Arrangements with multiple performance obligations are associated with the Diversigen business, which was discontinued in 2024.
Other revenues . Other revenues consist primarily of royalty income and funding from grants of research and development efforts. Royalties from licensees are based on third-party sales of licensed products and are recorded when the related third-party product sale occurs. The Company accounts for government grants by analogy to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance ("IAS 20"), as U.S. GAAP does not provide specific guidance. Grants are recognized when there is reasonable assurance that conditions will be met and the grant will be received, and are recognized in earnings over the periods in which the related costs are incurred. The expenses are recorded in research and development expense and the reimbursements are recorded in other revenue. Funding of research and development efforts and charitable support reimbursements are recorded as the activities are performed in accordance with the respective agreements.
Financing and payment . The Company's payment terms vary by the type and location of the customer and products or services offered. Payment terms differ by jurisdiction and customer, but payment is generally required in a term ranging from 30 to 120 days from date of shipment or satisfaction of the performance obligation.
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For certain products or services and customer types, the Company may require payment before the products are delivered or services are rendered to the customer.
Practical expedients and exemptions . Taxes assessed by governmental authorities, such as sales or value-added taxes, are excluded from product revenues.
Sales commissions are expensed when incurred if the amortization period is one year or less. These costs are recorded in sales and marketing expense in the consolidated statements of operations. If the amortization period exceeds one year, the Company defers the cost of the commission and expenses it over the life of the related sales contract.
Revenues by Product Line . The following table represents total net revenues by product line:
For the Years Ended December 31,
2025 2024 2023
HIV $ 49,802 $ 60,804 $ 60,823
Sample Management Solutions (1)
38,356 51,046 54,274
HCV 13,759 14,024 12,871
Other product and services revenues (2)
4,648 3,506 2,265
Risk Assessment Testing (3)
1,866 8,354 9,736
COVID-19 (4)
624 45,172 257,779
Molecular Services — 1,705 4,474
Net product and services revenues $ 109,055 $ 184,611 $ 402,222
Non-product and services revenues (5)
5,966 1,216 3,250
Net revenues $ 115,021 $ 185,827 $ 405,472
(1) Includes Genomics, Microbiome and Colli-Pee ® product revenues.
(2) Includes Syphilis revenues.
(3) Includes substance abuse testing product revenues.
(4) Includes COVID-19 Diagnostics and COVID-19 Sample Management Solutions revenues.
(5) Includes funded research and development contracts, royalty income and grant revenues.
Revenues by Geographic Area . The following table represents total net revenues by geographic area, based on the location of the customer:
For the Years Ended December 31,
2025 2024 2023
United States $ 78,252 $ 139,161 $ 361,660
Africa 23,993 32,745 29,254
Europe 7,393 8,424 8,111
Other regions 5,383 5,497 6,447
$ 115,021 $ 185,827 $ 405,472
Customer Concentrations. The following table represents customer concentration risk:
For the Years Ended December 31,
Net Revenues 2025 2024
Non-commercial customer N/A 24 %
December 31,
Accounts Receivable 2025 2024
Commercial customer 15 % 10 %
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Vendor Concentrations. The Company currently purchases certain products and critical components of the Company's products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, the Company could be subject to increased costs and substantial delays in the delivery of the Company's products to its customers. Third-party suppliers also manufacture certain products. The Company's inability to have a timely supply of any of these components and products could have a material adverse effect on the Company's business, as well as the Company's financial condition and results of operations.
Deferred Revenue. The Company records deferred revenue when funds are received prior to the recognition of the associated revenue. Deferred revenue as of December 31, 2025, 2024, and 2023 was comprised of customer prepayments of $ 1.2 million, $ 3.0 million, and $ 1.2 million, respectively. Deferred revenue as of December 31, 2025 was also comprised of $ 0.4 million of unearned grant income. Deferred revenue as of December 31, 2023 also included $ 0.4 million associated with a long-term contract that has variable pricing based on volume. The average price over the life of the contract was determined and revenue was recognized at that average price. The $ 0.4 million associated with the long-term contract at December 31, 2023 met the criteria to be recognized as revenue during the year ended December 31, 2024, and as such there was no equivalent balance remaining in deferred revenue at December 31, 2025 or 2024.
December 31,
2025 2024 2023
Deferred Revenue $ 1,518 $ 2,961 $ 1,559
The following table represents deferred revenue recognized:
For the Years Ended December 31,
Deferred Revenue Recognized 2025 2024
Accrued at beginning of year $ 2,484 $ 3,680
Research and Development
Research and development expenses consist of costs incurred in performing research and development activities, including salaries and benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses. Research and development costs are charged to expense as incurred.
Advertising Expenses
Advertising costs are charged to expense as incurred. During the years ended December 31, 2025, 2024, and 2023, the Company incurred $ 0.6 million, $ 0.5 million, and $ 1.6 million, respectively, in advertising expenses.
Stock-Based Compensation
The Company accounts for stock-based compensation to employees and directors using the fair value method. The Company recognizes compensation expense for stock option and restricted stock awards issued to employees and directors on a straight-line basis over the requisite service period of the award. The Company recognizes compensation expense related to performance-based restricted stock units based on assumptions as to what percentage of each performance target will be achieved. The Company evaluates these target assumptions on a quarterly basis and adjusts compensation expense related to these awards, as appropriate. To satisfy the exercise of stock options, issuance of restricted stock, or redemption of performance-based restricted stock units, the Company issues new shares rather than purchase shares in the open market.
Income Taxes
The Company follows the asset and liability method for accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax basis of assets and liabilities, as well as operating loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates for the respective taxing jurisdiction that are expected to apply to taxable income in the years in which those temporary differences and operating loss and credit carryforwards are expected to be recovered, settled or utilized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
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The Company assesses the realizability of its net deferred tax assets on a quarterly basis. If, after considering all relevant positive and negative evidence, it is more likely than not that some portion or all of the net deferred tax assets will not be realized, the Company reduces its net deferred tax assets by a valuation allowance. The realization of the net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the Company's net operating loss carryforwards.
Uncertain Tax Positions
Assets and liabilities are established for uncertain tax positions taken or positions expected to be taken in income tax returns when such positions fail to meet the "more likely than not" threshold based on the technical merits of the positions. The Company assesses whether previously unrecognized tax benefits may be recognized when tax positions are (1) more likely than not of being sustained based on their technical merits, (2) effectively settled through examination, negotiation or litigation, or (3) settled through actual expiration of the relevant tax statutes. The assessment of an uncertain tax position requires significant judgment.
Foreign Currency Translation
The assets and liabilities of the Company's foreign operations are translated into U.S. dollars at current exchange rates as of the balance sheet date, and revenues and expenses are translated at average exchange rates for the period. Resulting translation adjustments are reflected in accumulated other comprehensive loss, which is a separate component of stockholders’ equity.
Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than functional currency are included in the Company's consolidated statements of operations in the period in which the change occurs. Net foreign exchange gains (losses) resulting from foreign currency transactions included in other income in the Company's consolidated statements of operations were $( 0.9 ) million, $ 1.2 million, and $( 0.1 ) million for the years ended December 31, 2025, 2024, and 2023, respectively.
Earnings (Loss) Per Share
Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share is computed in a manner similar to basic earnings (loss) per share except that the weighted-average number of shares outstanding is increased to include incremental shares from the assumed vesting or exercise of dilutive securities, such as common stock options, unvested restricted stock or performance stock units, unless the impact is anti-dilutive. The number of incremental shares is calculated by assuming that outstanding stock options were exercised and unvested restricted shares and performance stock units were vested, and the proceeds from such exercises or vesting were used to acquire shares of common stock at the average market price during the reporting period. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.
For the Years Ended December 31,
2025 2024 2023
Net (loss) income $ ( 68,731 ) $ ( 19,500 ) $ 53,655
Weighted average shares of common stock outstanding:
Basic 73,485 74,434 73,348
Dilutive effect of stock options, restricted stock, and performance stock units — — 1,041
Diluted 73,485 74,434 74,389
Loss (earnings) per share:
Basic $ ( 0.94 ) $ ( 0.26 ) $ 0.73
Diluted $ ( 0.94 ) $ ( 0.26 ) $ 0.72
For the years ended December 31, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 572 and 896 shares, respectively, were excluded from the computation of diluted loss per share. For the year ended December 31, 2023, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 1,778 shares were excluded from the computation of diluted earnings per share as their inclusion would have been antidilutive.
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Accumulated Other Comprehensive Loss
The Company classifies items of other comprehensive income (loss) by their nature and discloses the accumulated balance of other comprehensive income (loss) separately from accumulated deficit and additional paid-in capital in the stockholders’ equity section of the Company's consolidated balance sheets.
The Company has defined the Canadian dollar as the functional currency of the Company's Canadian subsidiary, DNAG, and the Company has defined the Euro as the functional currency of the Company's Belgian subsidiary, Novosanis. The results of operations are translated into U.S. dollars, which is the reporting currency of the Company.
Change in accumulated other comprehensive loss by component is listed below:
Foreign Currency Total
Balance at December 31, 2024 $ ( 24,360 ) $ ( 24,360 )
Other comprehensive gain 5,956 5,956
Balance at December 31, 2025 $ ( 18,404 ) $ ( 18,404 )
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Recent Accounting Pronouncements
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures . The purpose of the update was to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and incomes taxes paid information. The amendments in this ASU are effective for annual periods beginning after December 15, 2024. The amendments may be applied prospectively or retrospectively, and early adoption is permitted. Management has implemented on a prospective basis for the year ended December 31, 2025.
In November 2024, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses . The purpose of this update was to require disclosure, in the notes to financial statements, of specified information about certain costs and expenses on a disaggregated basis. The amendments in the ASU are effective for all public business entities for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The amendments are to be applied either prospectively to financial statements issued for reporting periods after the effective date of the update or retrospectively to any or all prior periods presented in the financial statements. Management is evaluating the impact on the Company's consolidated financial statements.
In March 2024, the FASB issued ASU No. 2024-01, Compensation—Stock Compensation (Topic 718), Measurement of Credit Losses for Accounts Receivable and Contract Assets . The purpose of this update was to provide illustrative examples to demonstrate how an entity should apply guidance to determine whether profits interests and similar awards should be accounted for in accordance with Topic 718. For public business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2024, and interim periods within those fiscal periods. The amendments may be applied prospectively or retrospectively, and early adoption is permitted. Management does not expect an impact on the Company's consolidated financial statements.
In July 2025, the FASB issued ASU No. 2025-05, Financial Instruments—Credit Losses (Topic 326), Scope Application of Profits Interest and Similar Awards . The purpose of this update was to address challenges encountered when applying the guidance in Topic 326, Financial Instruments—Credit Losses, to current accounts receivable and current contract assets arising from transactions accounted for under Topic 606, Revenue from Contracts with Customers illustrative examples to demonstrate how an entity should apply guidance to determine whether profits interests and similar awards should be accounted for in accordance with Topic 718. For all business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2025, and interim periods within those fiscal periods. The amendments are applied prospectively, and early adoption is permitted. Management does not expect an impact on the Company's consolidated financial statements.
In September 2025, the FASB issued ASU No. 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40), Targeted Improvements to the Accounting for Internal-Use Software . The purpose of this update was to modernize the accounting for software costs. For all business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal periods. The amendments can be applied prospectively, a modified transition or retrospectively. Early adoption is permitted as of the beginning of an annual reporting period. Management does not expect an impact on the Company's consolidated financial statements.
In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topic 832), Accounting for Government Grants Received by Business Entities . The purpose of this update was to improve US GAAP by establishing authoritative guidance on the accounting for government grants received by business entities. For public business entities, the amendments in this ASU are effective for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance. The amendments can be applied under a modified prospective approach, a modified retrospective approach, or a retrospective approach. Management is evaluating the impact on the Company's consolidated financial statements.
In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270), Narrow-Scope Improvements . The purpose of this update was to improve the navigability of the required interim disclosures and clarifying when that guidance is applicable. The update also provides additional guidance on what disclosures should be provided in interim periods and adds a principal that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. For public business entities, the amendments in this ASU are effective for interim
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reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments in this update can be applied either prospectively or retrospectively to any or all prior periods presented in the financial statements. Management is evaluating the impact on the Company's consolidated financial statements.
3. GOVERNMENT CAPITAL CONTRACTS:
In September 2021, the Company entered into an agreement for $ 109.0 million in funding from the U.S. Department of Defense (the "DOD"), in coordination with the Department of Health and Human Services, to build additional manufacturing capacity in the United States for its InteliSwab ® COVID-19 Rapid Tests as part of the nation’s pandemic preparedness plan. In accordance with the milestone payment schedule, 15 % of the total was not billed and funded until the completion of the final validation testing, which occurred in October 2023. The Company began receiving funds from the DOD in January 2022 and received $ 109.0 million as of December 31, 2023. In connection with the completion of the contract in the fourth quarter of 2023, all funds were received.
Activity for these capital contracts is accounted for pursuant to International Accounting Standards ("IAS") 20, Accounting for Government Grants and Disclosure of Government Assistance . Funding received in relation to capital-related costs incurred for government contracts is recorded as a reduction to the cost of property, plant and equipment and reflected within investing activities in the consolidated statements of cash flows and associated unpaid liabilities and government proceeds receivable are considered non-cash changes in such balances within the operating section of the consolidated statements of cash flows.
Amounts earned for the Company's guaranteed profit which covered project management costs were recognized straight-line in other income over the term of the government contract. The Company recognized no such income during the years ended December 31, 2025 and 2024. The Company recognized $ 2.8 million of such income during the year ended December 31, 2023. Additionally, in connection with the completion of the contract, the Company recognized $ 12.8 million in excess of the guaranteed profit in other income in the Company's consolidated statement of operations during the year ended December 31, 2023, which reflects the difference in overall spend compared to the firm fixed price contract amount of $ 109.0 million.
The DOD also reimbursed the Company for certain engineering consulting costs. These expenses are reflected in research and development expenses as incurred with the corresponding amount presented in other income. The Company recognized no such costs during the years ended December 31, 2025 and 2024. The Company recognized $ 2.0 million of such costs during the year ended December 31, 2023.
The activity corresponding to the government contracts included in the Company's consolidated statements of cash flows is as follows:
December 31,
2023
Cost of assets, cumulative $ 86,993
Reduction for funding earned to date, not yet received —
Reduction for funding received to date ( 86,993 )
Total property, plant and equipment, net $ —
4. INVENTORIES:
December 31, December 31,
2025 2024
Raw materials $ 14,831 $ 17,002
Work in process 56 420
Semi-finished goods 1,965 2,890
Finished goods 14,208 13,885
$ 31,060 $ 34,197
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During the years ended December 31, 2025, 2024, and 2023, the Company recorded writedowns to inventory which had a cost of $ 2.9 million, $ 2.6 million, and $ 8.9 million, respectively. Adjustments for the year ended December 31, 2025 were primarily driven by the write down of COVID-19 inventory and normal operating scrap. Adjustments for the year ended December 31, 2024 were primarily driven by the write down of inventory associated with the Company's exit of the Risk Assessment Testing business and normal operating scrap. Adjustments for the year ended December 31, 2023 were primarily related to reduction in COVID-19 demand and the need to reserve for excess inventory levels.
5. PROPERTY, PLANT, AND EQUIPMENT, NET:
December 31, December 31,
2025 2024
Land $ 1,118 $ 1,118
Buildings and improvements 39,071 36,152
Machinery and equipment 46,202 51,015
Computer equipment and software 11,101 11,502
Furniture and fixtures 1,632 1,621
Construction in progress 2,931 9,615
102,055 111,023
Accumulated depreciation ( 62,876 ) ( 65,918 )
$ 39,179 $ 45,105
During the first quarter of 2024, the Company initiated a strategic plan to transition away from the microbiome molecular sequencing services business and to cease operations at its Belgium location. As a result of these decisions, the Company determined that the carrying values of all of associated property, plant, and equipment were not recoverable and recorded an aggregate pre-tax asset impairment charge of $ 1.8 million during the year ended December 31, 2024. All of these assets were disposed of as of December 31, 2024.
During the second quarter of 2024, the Company determined a manufacturing line will no longer be utilized. As a result of this decision, the Company determined that the carrying value of the equipment was not recoverable and recorded an aggregate pre-tax impairment charge of $ 1.1 million during the year ended December 31, 2024.
During the year ended December 31, 2023 the Company determined several manufacturing lines would not be utilized due to changes in forecasted demand for the products the lines are intended to produce. Additionally, the Company elected not to proceed with certain leasehold improvements to its research and development laboratories. As a result of these decisions, the Company determined that the carrying values of the equipment and leasehold improvements were not recoverable and recorded aggregate pre-tax asset impairment charges of $ 2.3 million for the year ended December 31, 2023.
During the year ended December 31, 2023, the Company shortened the useful lives of machinery and equipment utilized for InteliSwab® production in Thailand. This reduction in useful lives resulted in $ 6.9 million of accelerated depreciation during 2023, recorded in cost of products and services sold. Also during 2023, the Company shortened the useful lives of leasehold improvements and equipment due a lease termination. This reduction in useful lives resulted in an additional $ 0.5 million of accelerated depreciation recorded in cost of products and services sold.
Depreciation expense for 2025, 2024, and 2023 was $ 9.9 million, $ 9.8 million, and $ 17.9 million, respectively.
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6. GOODWILL AND OTHER INTANGIBLE ASSETS:
Changes in goodwill are as follows:
Reporting Unit
Diagnostics Collection Devices Total
Balance at January 1, 2024 $ — $ 35,696 $ 35,696
Acquisition 6,388 — 6,388
Change related to foreign currency translation — ( 1,754 ) ( 1,754 )
Balance at December 31, 2024 6,388 33,942 40,330
Acquisition 1,775 — 1,775
Change related to foreign currency translation — 1,258 1,258
Balance at December 31, 2025 $ 8,163 $ 35,200 $ 43,363
On November 30, 2025, the Company performed its quantitative annual goodwill impairment test. The Company utilizes a combination of the income approach and market approach in determining the fair value of its two reporting units. The test concluded that the carrying value of the Company's reporting units was below fair value indicating there was no impairment of goodwill.
Intangible assets consist of the following:
December 31, 2025
Amortization
Period (Years) Gross Accumulated Amortization Net
Definite Life Intangible Assets
Customer relationships 10 $ 9,134 $ ( 9,134 ) $ —
Patents and product rights 5 7,596 ( 7,596 ) —
Developed technology 7 - 15
8,995 ( 7,095 ) 1,900
Trade names 5 - 15
3,501 ( 3,355 ) 146
29,226 ( 27,180 ) 2,046
Indefinite Life Intangible Assets
IPR&D technology (Note 13) N/A 17,000 — 17,000
$ 46,226 ( 27,180 ) 19,046
December 31, 2024
Amortization
Period (Years) Gross Accumulated
Amortization Net
Definite Life Intangible Assets
Customer relationships 10 $ 10,858 $ ( 10,858 ) $ —
Patents and product rights 5 7,495 ( 7,399 ) 96
Developed technology 7 - 10
10,169 ( 10,169 ) —
Trade names 5 - 15
4,327 ( 3,988 ) 339
32,848 ( 32,413 ) 435
Indefinite Life Intangible Assets
IPR&D technology (Note 13) N/A 17,000 — 17,000
$ 49,848 $ ( 32,413 ) $ 17,435
During 2023, the Company identified a triggering event to test for the recoverability of intangible assets given the decline in the Company's market capitalization leading up to and as of its annual goodwill impairment testing date. The Company performed an undiscounted cash flow analysis and determined the carrying value of the developed technology, trade names, and customer relationships intangible assets could not be recovered through the sum of the undiscounted future
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cash flows. The Company used an income approach to determine the fair value of the developed technology and customer relationships intangible assets and the relief from royalty method for the trade names. As a result of this analysis, the Company determined the intangible assets associated with Diversigen and Novosanis were impaired as the fair value of the developed technology, trade names, and customer relationships did not exceed their carrying value. The Company recognized a pre-tax impairment charge of $ 6.2 million during the year ended December 31, 2023, which is reported in loss on impairments in the Company's consolidated statement of operations.
Also in 2023, the Company determined that its remaining developed technology intangible asset was fully impaired. As a result of failed stability studies, the Company decided to no longer pursue the technology. The Company recognized a pre-tax impairment charge of $ 2.4 million during the year ended December 31, 2023 which is reported in loss on impairments in the Company's consolidated statement of operations.
Amortization expense for 2025, 2024, and 2023 was $ 0.3 million, $ 0.7 million, and $ 2.0 million, respectively.
Amortization expense for each of the five succeeding fiscal years and beyond is estimated as follows:
2026 $ 336
2027 190
2028 190
2029 190
2030 190
Beyond 950
$ 2,046
7. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES:
December 31, December 31,
2025 2024
Payroll and related benefits $ 5,255 $ 11,147
Professional fees 1,938 2,469
Sales tax payable 1,152 1,339
Other 2,804 5,224
$ 11,149 $ 20,179
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8. TERMINATION BENEFITS:
2023 Reduction in Workforce
During the first and second quarters of 2023, the Company executed a reduction in workforce. This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations . The charges for termination benefits included in the Company's consolidated statements of operations are as follows:
For the Year Ended December 31,
2023
Cost of products and services sold $ 369
Research and development 566
Sales and marketing 1,543
General and administrative 787
$ 3,265
As of December 31, 2024 the Company had fully paid the $ 3.3 million related to the reduction in workforce. This reduction in workforce was completed by June 30, 2024.
Q1 2024 Reduction in Workforce
During the first quarter of 2024, the Company executed a reduction in workforce largely affecting its COVID-19 manufacturing workforce. The charges for termination benefits included in the Company's consolidated statement of operations are as follows:
For the Year Ended December 31,
2024
Cost of products and services sold $ 231
Research and development 87
Sales and marketing 69
General and administrative 17
$ 404
As of December 31, 2024, the Company had fully paid the $ 0.4 million related to the reduction in workforce. This reduction in workforce was completed by December 31, 2024.
Q2 2024 Reduction in Workforce
During the second quarter of 2024, the Company executed an additional reduction in workforce as the Company notified employees of its intention to consolidate its Novosanis site in Belgium into other locations by the end of December 31, 2024, discontinue the Diversigen molecular services line of business by the end of June 30, 2024, and consolidate facilities by bringing third-party manufacturing activities into its Pennsylvania facilities by the end of the third quarter of 2025. The charges for termination benefits included in the Company's consolidated statements of operations are as follows:
For the Year Ended December 31,
2024
Cost of products and services sold $ 889
Research and development 478
Sales and marketing 125
General and administrative 160
$ 1,652
As of December 31, 2025 the Company had $ 0.1 million accrued and had paid $ 1.5 million related to the reduction in workforce. No additional expenses were incurred during the year ended December 31, 2025. The Company expects this reduction in workforce to be completed by March 2026.
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Q3 2024 Reduction in Workforce
During the third quarter of 2024, the Company executed a reduction in workforce largely as the Company notified certain employees of its intention to discontinue its risk assessment business. Additional employees were notified in the fourth quarter of 2024. The charges for termination benefits included in the Company's consolidated statements of operations are as follows:
For the Year Ended December 31,
2024
Cost of products and services sold $ 246
Research and development 33
Sales and marketing 782
General and administrative 141
$ 1,202
As of December 31, 2025 the Company had $ 0.1 million accrued and had paid $ 1.1 million related to the reduction in workforce. No additional expense was incurred during the year ended December 31, 2025. The Company expects this reduction in workforce to be completed by September 2026.
9. LEASES:
The Company determines whether an arrangement is a lease at inception. The Company has operating and finance leases for corporate offices, warehouse space and equipment (including vehicles). As of December 31, 2025, the Company is the lessee in all lease agreements. The Company's leases have remaining lease terms of one to eight years , some of which include options to extend the leases based on agreed upon terms, and some of which include options to terminate the leases within one year .
The Company also subleased two of its leased corporate offices. One of the subleases was terminated during the third quarter of 2025 as the Company exited the head lease agreement. The Company's remaining sublease has a remaining term of approximately one year . The Company presents the operating right-of-use asset amortization and the change in operating lease liabilities on the other non-cash amortization line item of the consolidated statements of cash flows.
As most of the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments.
The Company has lease agreements that contain both lease and non-lease components (e.g., common-area maintenance). For these agreements, the Company accounts for lease components separately from non-lease components.
During the first quarter of 2024, the Company identified a triggering event to test for the recoverability of all the ROU assets of both the Diversigen and Novosanis subsidiaries, given the Company's decision to initiate a strategic plan to transition away from the microbiome molecular sequencing services business and close its Belgian operations. The Company performed an undiscounted cash flow analysis and determined the carrying values of the ROU assets could not be recovered through the sum of the undiscounted future cash flows and were impaired. During the year ended December 31, 2024 the Company recognized aggregate pre-tax impairment charges of $ 1.2 million and $ 0.3 million to its operating and finance ROU assets, respectively. These charges are reported in the Company's consolidated statement of operations.
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The components of lease expense are as follows:
For the Years Ended December 31,
2025 2024 2023
Operating lease cost $ 2,285 $ 1,729 $ 2,407
Variable and short-term lease cost 37 549 381
Sublease income ( 161 ) ( 151 ) ( 155 )
Finance lease cost:
Amortization of right-of use assets 61 331 1,091
Interest on lease liabilities 8 22 51
Total finance lease cost 69 353 1,142
Total lease cost $ 2,230 $ 2,480 $ 3,775
Supplemental cash flow information related to leases is as follows:
For the Years Ended December 31,
2025 2024 2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases $ 2,156 $ 1,901 $ 1,863
Operating cash flows from financing leases 8 22 51
Financing cash flows from financing leases 61 842 1,345
Non-cash activity:
Right-of-use assets obtained in exchange for operating lease obligations 169 4,086 4,363
Right-of-use assets obtained in exchange for finance lease obligations 62 193 334
Supplemental balance sheet information related to leases is as follows:
December 31,
2025 2024
Weighted Average Remaining Lease Term
Weighted-average remaining lease term — operating leases 6.70 years 7.57 years
Weighted-average remaining lease term — finance leases 2.70 years 3.74 years
Weighted Average Discount Rate
Weighted-average discount rate — operating leases 4.48 % 4.44 %
Weighted-average discount rate — finance leases 5.10 % 4.82 %
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As of December 31, 2025, minimum lease payments by period are expected to be as follows:
Finance Operating
2026 $ 70 $ 2,548
2027 65 2,287
2028 34 2,157
2029 6 2,097
2030 — 2,106
Thereafter — 3,778
Total minimum lease payments 175 14,973
Less: imputed interest ( 12 ) ( 1,939 )
Present value of lease liabilities $ 163 $ 13,034
10. INCOME TAXES:
Income (loss) before income tax expense consists of the following:
For the Years Ended December 31,
2025 2024 2023
United States $ ( 62,742 ) $ ( 21,523 ) $ 61,671
Foreign ( 1,844 ) 5,522 ( 5,413 )
$ ( 64,586 ) $ ( 16,001 ) $ 56,258
In July of 2025, the One Big Beautiful Bill Act of 2025 (the “OBBBA”) was enacted in the U.S. The OBBBA includes several significant tax provisions, including the reinstatement of full expensing of domestic research and development costs among other domestic and international changes. The OBBBA is not expected to have a significant impact on the Company’s tax expense or cash paid for taxes. Our results for the year ended December 31, 2025 include the impact of the OBBBA on our consolidated financial statements.
The components of income tax expense (benefit) are as follows:
For the Years Ended December 31,
2025 2024 2023
Current
Federal $ — $ 229 $ —
State 124 111 1,896
Foreign ( 176 ) 2,116 605
( 52 ) 2,456 2,501
Deferred
Federal ( 11,186 ) ( 2,962 ) 13,570
State 870 1,368 ( 382 )
Foreign 10,355 4,365 ( 1,867 )
39 2,771 11,321
Increase (decrease) in valuation allowance 1,814 ( 3,428 ) ( 11,219 )
1,853 ( 657 ) 102
Total income tax expense $ 1,801 $ 1,799 $ 2,603
For the year ended December 31, 2025, the Company recorded net foreign tax benefit of $ 0.3 million. For the years ended December 31, 2024, and 2023 the Company recorded net foreign income tax expense of $ 1.4 million, and $ 0.7 million, respectively. For the years ended December 31, 2025, 2024, and 2023 the Company recorded U.S. federal tax expense of
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$ 0.2 million, $ 0.2 million, and $ 0.0 million, respectively and state tax expense of $ 1.9 million, $ 0.1 million, and $ 1.9 million respectively.
Total cash paid for income taxes was as follows:
For the Year Ended December 31, 2025
Federal $ —
State:
Utah ( 100 )
Other 74
( 26 )
Foreign:
Canada 2,539
United Kingdom ( 672 )
1,867
Total cash paid for income taxes (net of refunds) (1)
$ 1,841
(1) Total cash paid for income taxes during the year ended December 31, 2024 was $ 1.8 million. The Company received income tax refunds of $ 4.9 million for year ended December 31, 2023 (prior to adoption of ASU 2023-09).
The reconciliation of the statutory United States federal income tax rate to the Company's effective tax rate is as follows:
For the Years Ended December 31,
2025 2024 2023
Statutory U.S. federal income tax rate 21.0 % 21.0 % 21.0 %
Nondeductible executive compensation ( 1.1 ) ( 8.5 ) 0.5
Impact of stock-based payment awards ( 1.8 ) ( 2.3 ) ( 0.3 )
Tax effect of foreign items ( 0.6 ) ( 1.9 ) ( 0.4 )
State income taxes, net of federal benefit 1.3 ( 9.1 ) 2.0
U.S. and foreign tax credits 1.3 1.2 1.3
Uncertain tax positions ( 2.9 ) — —
Nondeductible expenses and other 1.2 ( 2.4 ) 0.9
Nondeductible transaction costs ( 0.2 ) ( 2.1 ) —
NOL adjustment, domestic ( 2.2 ) — —
NOL adjustment, foreign 25.5 ( 31.4 ) —
Change in the estimated fair value of acquisition-related contingent consideration ( 1.4 ) — —
Acquisition adjustments ( 8.7 ) — —
Non-controlling interests ( 0.7 ) 2.2 —
Change in valuation allowance, federal and state ( 14.4 ) ( 10.0 ) —
Change in valuation allowance, foreign ( 19.0 ) 32.1 ( 20.4 )
Effective tax rate ( 2.7 ) % ( 11.2 ) % 4.6 %
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The reconciliation of the statutory United States federal income tax rate to the Company's effective tax rate is as follows:
For the Year Ended December 31, 2025
Dollars Percentage
Statutory U.S. federal income tax rate $ ( 14,055 ) 21.0 %
State and local income taxes, net of federal income tax effect (1)
325 ( 0.5 ) %
Foreign tax effects
United Kingdom
Change in NOL limitation ( 17,062 ) 25.5 %
Intangible acquisition adjustment 4,524 ( 6.7 ) %
Change in valuation allowances 12,728 ( 19.0 ) %
Other ( 195 ) 0.3 %
Other foreign jurisdictions 114 ( 0.2 ) %
Effect of changes in tax laws/rates enacted in the current period — — %
Effect of cross-border tax laws
Global intangible low-taxed income 523 ( 0.8 ) %
Tax credits
Research and development tax credits ( 536 ) 0.8 %
Changes in valuation allowances 8,700 ( 13.0 ) %
Nontaxable or nondeductible items
Share based payment awards 773 ( 1.1 ) %
Nondeductible officer's compensation 714 ( 1.1 ) %
Change in the estimated fair value of acquisition-related contingent consideration 960 ( 1.4 ) %
Other 192 ( 0.3 ) %
Changes in unrecognized tax benefits 1,728 ( 2.6 ) %
Acquisition adjustments 1,285 ( 1.9 ) %
NOL adjustment 1,441 ( 2.2 ) %
Other adjustments ( 358 ) 0.5 %
Effective tax rate $ 1,801 ( 2.7 ) %
(1) The tax effect in this category was primarily driven by state taxes in Pennsylvania (greater than 50%).
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Deferred income taxes reflect the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting purposes and tax purposes, and net operating loss and tax credit carryforwards. Significant components of the Company's deferred tax assets (liabilities) are as follows:
December 31,
2025 2024
Deferred tax assets:
Net operating loss carryforwards $ 54,859 $ 55,583
Inventories 2,108 2,344
Capitalized research and development costs 10,889 12,946
Accruals and reserves currently not deductible 1,805 2,754
Depreciation and amortization 114 —
Lease liabilities 2,254 2,497
Stock-based compensation 3,244 3,303
Tax credit carryforwards 6,628 4,184
Net deferred tax asset 81,901 83,611
Valuation allowance ( 77,006 ) ( 75,191 )
Total deferred tax assets $ 4,895 $ 8,420
Deferred tax liabilities:
Depreciation and amortization — ( 2,017 )
Acquired intangible assets ( 2,220 ) ( 3,981 )
Right-of-use assets ( 2,073 ) ( 2,266 )
Deferred compensation ( 331 ) —
Total deferred tax liabilities $ ( 4,624 ) $ ( 8,264 )
Net deferred tax asset $ 271 $ 156
In assessing the realizability of the Company's deferred tax asset, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent upon several factors, including the generation of sufficient taxable income, to realize the NOL carryforwards. In 2008, the Company established a full valuation allowance against the Company's U.S. deferred tax asset. The Company has not achieved a level of sustained profitability that would, in the Company's judgment, support the release of the valuation allowance. Management believes the full valuation allowance is still appropriate as of December 31, 2025 and 2024. As a result, no U.S. federal income tax benefit was recorded for the years ended December 31, 2025, 2024, and 2023.
The Company's federal NOL carryforwards consist of $ 232.9 million from existing business along with $ 12.9 million of acquired NOL carryforwards. None of these NOL carryforwards have an expiration date. The Company does not have any foreign NOL carryforwards as of December 31, 2025. As of December 31, 2024, the Company's foreign NOL carryforwards consisted of $ 63.0 million of acquired NOL carryforwards. The foreign NOLs were reduced to zero due to loss limitation rules. The Company's state NOL carryforwards consist of $ 57.6 million from existing business along with $ 7.2 million of acquired NOL carryforwards. The state NOL carryforwards have expirations as follows:
Year of Expiration NOLs
2026 - 2041 $ 30,419
2042 - 2055 20,023
Non-Expiring 14,350
$ 64,792
The Tax Reform Act of 1986 contains provisions under Internal Revenue Code (“IRC”) Section 382 and Section 383 that limit the annual amount of federal and state NOL carryforwards and tax credits that can be used in any given year in the
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event a significant change in ownership. The Company does not believe that there is a Section 382 limitation that will impair the Company's future ability to utilize NOLs to offset the Company's future taxable income. The Company continues to review ownership changes on an annual basis and the Company does not believe it has had a subsequent ownership change that would impact the NOLs. The Company acquired 382 limited NOL carryforwards as part of its acquisition of BioMedomics. These NOL carryforwards have no expiration date. The Company has not undertaken any formal 382 or 383 studies that would indicate any limitations to its NOL or credit carryforwards. However, any such study could potentially limit the NOL and credit carryforwards of the Company.
It is still the Company's intention to continue to permanently reinvest the historical undistributed earnings of the Company's foreign subsidiary to the extent that the Company will not incur any additional tax expense associated with foreign withholding or other local tax expense on the future cash transfers. As such, deferred taxes have not been recorded on the unremitted earnings of the foreign subsidiary as of December 31, 2025.
As of December 31, 2025, the Company's gross unrecognized tax benefits totaled $ 2.1 million, and based upon the valuation allowance for the Company's U.S. operations, the recognition of any tax benefit would not impact the Company's effective tax rate. The 2025 addition of $ 1.7 million is not offset by the valuation allowance and its reversal would impact the Company’s effective tax rate. The Company records interest and penalties related to unrecognized tax benefits as a component of income tax expense. Interest and penalties were $ 0.2 million in 2025, and immaterial in 2024 and 2023. As a result of the Company's NOL carryforward position, the Company has been subject to audit by the Internal Revenue Service since the Company's inception, as well as by several jurisdictions for the years ended September 30, 1998 through December 31, 2025.
The reconciliation of the Company's unrecognized tax benefits is as follows:
2025 2024 2023
Balance at January 1 $ 333 $ 304 $ 373
Additions for tax positions of prior periods 1,729 29 —
Reductions for tax positions of prior periods — — ( 69 )
Balance at December 31 $ 2,062 $ 333 $ 304
11. STOCKHOLDERS' EQUITY:
Stock-Based Awards
The Company grants stock-based awards under the OraSure Technologies, Inc. Stock Award Plan, as amended (the “Stock Plan”). The Stock Plan permits stock-based awards to employees, outside directors and consultants or other third-party advisors. Awards which may be granted under the Stock Plan include qualified incentive stock options, nonqualified stock options, stock appreciation rights, restricted awards, performance awards and other stock-based awards.
As of December 31, 2025, 5,959 shares were available for future grants under the Stock Plan.
Under the terms of the Stock Plan, nonqualified stock options may be granted to eligible employees, including the Company's officers at a price not less than 75 percent of the fair market value of a share of common stock on the date of grant. The option term and vesting schedule of such awards may be either unlimited or have a specified period in which to vest and be exercised. To date, options generally have been granted with ten-year exercise periods and an exercise price not less than the fair market value on the date of grant. Options generally vest over four years , with one quarter of the options vesting one year after grant and the remainder vesting on a monthly basis over the next three years.
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The fair value of each stock option was estimated on the date of the grant using the Black-Scholes option-pricing model using the following weighted-average assumptions:
For the Years Ended December 31,
Black-Scholes Option Valuation Assumptions 2025 2024 2023
Risk-free interest rate (1)
4.04 % 4.14 % 4.23 %
Expected dividend yield — — —
Expected stock price volatility (2)
53 % 53 % 51 %
Expected life of stock options (in years) (2)
6 5 5
(1) Based on the constant maturity interest rate of U.S. Treasury securities whose term is consistent with the expected life of the Company's stock options.
(2) Based upon historical experience.
The weighted-average grant date fair value of stock options granted during the years ended December 31, 2025, 2024, and 2023 was $ 3.43 , $ 3.68 and $ 3.24 , respectively.
Compensation expense recognized in the financial statements related to stock options was $ 1.6 million, $ 1.4 million, and $ 1.3 million for the years ended December 31, 2025, 2024, and 2023, respectively.
The aggregate intrinsic value of options exercised during the years ended December 31, 2025, 2024, and 2023 (the amount by which the market price of the stock on the date of exercise exceeded the exercise price) was $ 0.0 thousand, $ 38.4 thousand, and $ 43.0 thousand, respectively.
The following table summarizes the stock option activity under the Stock Plan:
Options Weighted-
Average
Exercise Price
Per Share Weighted-
Average
Remaining
Contractual
Term
(in years) Aggregate Intrinsic Value
Outstanding on January 1, 2025 2,237 $ 8.73
Granted 1,393 3.43
Exercised — —
Expired ( 132 ) 9.02
Forfeited ( 119 ) 4.72
Outstanding on December 31, 2025 3,379 $ 6.68 6.97 $ —
Vested or expected to vest as of December 31, 2025 3,376 $ 6.67 5.00 $ —
Exercisable on December 31, 2025 1,655 $ 9.24 5.00 $ —
As of December 31, 2025, there was $ 3.2 million of unrecognized compensation expense related to unvested option awards that is expected to be recognized over a weighted-average period of 2.6 years.
Net cash proceeds from the exercise of stock options were $ — million, $ 0.2 million and $ 0.3 million for the years ended December 31, 2025, 2024, and 2023, respectively. As a result of the Company's net operating loss carryforward position, no actual income tax benefit was realized from stock option exercises for these periods.
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The following table summarizes information about stock options outstanding as of December 31, 2025:
Options Outstanding Options Exercisable
Range of Exercise Prices Number
Outstanding Weighted-
Average
Remaining
Contractual
Term
(in years) Weighted-
Average
Exercise
Price Per
Share Number
Exercisable Weighted-
Average
Exercise
Price Per
Share
$ 2.46 - $ 6.56
1,855 8.40 $ 4.17 382 $ 6.00
$ 7.13 - $ 10.69
1,157 5.86 7.84 907 8.00
$ 12.90 - $ 19.35
324 3.42 14.89 324 14.89
$ 21.64 - $ 32.46
43 2.03 $ 21.65 43 $ 21.65
3,379 6.97 $ 6.67 1,656 $ 9.24
The Stock Plan also permits the Company to grant restricted shares and restricted units of the Company's common stock to eligible employees, including officers, and the Company's outside directors. Generally, these shares or units are nontransferable until vested and are subject to vesting requirements and/or forfeiture, as determined by the Company's Compensation Committee or Board of Directors. The market value of these shares and units at the date of grant is recognized on a straight-line basis over the period during which the vesting restrictions lapse. Compensation cost of $ 6.1 million, $ 6.9 million and $ 7.6 million related to restricted shares was recognized during the years ended December 31, 2025, 2024, and 2023, respectively.
The following table summarizes restricted stock award and restricted stock units activity under the Stock Plan:
Units Weighted-
Average Grant
Date Fair
Value
Issued and unvested, January 1, 2025 1,694 $ 6.60
Granted 2,226 3.25
Vested ( 1,128 ) 6.05
Forfeited ( 182 ) 4.55
Issued and unvested, December 31, 2025 2,610 $ 4.13
Issued and expected to vest, December 31, 2025 2,610 $ 4.13
As of December 31, 2025, there was $ 6.3 million of unrecognized compensation expense related to unvested restricted stock awards and unvested restricted stock units that is expected to be recognized over a weighted average period of 1.7 years.
In connection with the vesting of restricted shares during the years ended December 31, 2025, 2024, and 2023, the Company purchased and immediately retired 363 , 617 and 262 shares with aggregate values of $ 1.2 million, $ 3.4 million and $ 1.4 million, respectively, in satisfaction of minimum tax withholding and exercise obligations.
The Company grants performance-based restricted stock units (“PSUs”) to certain executives. Vesting of these PSUs is dependent upon achievement of certain performance-based metrics during a three-year period, from the date of grant. Assuming achievement of each performance-based metric, the executive must also generally remain in the Company's service for three years from the grant date. Performance shares were granted based on the achievement of three-year cumulative revenue metrics with a market-based condition, or a total shareholder return modifier. PSUs are converted into shares of the Company's common stock once vested and the number of shares actually earned at the end of the performance period will vary, based on actual performance, from 0 % to 150 % of the target number of performance share units granted. Upon grant of the PSUs, the Company recognizes compensation expense related to these awards based on assumptions as to what percentage of each target will be achieved. The Company evaluates these target assumptions on a quarterly basis and adjusts compensation expense related to these awards, as appropriate.
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Compensation cost of $ 2.4 million, $ 3.6 million and $ 1.8 million related to the PSUs was recognized during the years ended December 31, 2025, 2024, and 2023, respectively.
The following table summarizes PSU activity under the Stock Plan:
Units Weighted-
Average Grant
Date Fair
Value
Issued and unvested, January 1, 2025 1,454 $ 7.19
Granted (1)
1,009 4.30
Performance adjustment (2)
12 N/A
Vested ( 513 ) 5.18
Forfeited ( 181 ) 5.93
Issued and unvested, December 31, 2025 1,781 $ 6.24
Issued and expected to vest, December 31, 2025 1,781 $ 6.24
(1) Grant activity for all PSUs disclosed at target.
(2) Reflects the performance adjustment based on actual performance measured at the end of the performance period.
As of December 31, 2025, there was $ 3.7 million of unrecognized compensation expense related to unvested performance stock units that is expected to be recognized over a weighted average period of 1.9 years.
In connection with the vesting of performance stock units during the year ended December 31, 2025, 2024 and 2023, the Company purchased and immediately retired 201 , 23 , and 86 shares with aggregate values of $ 0.6 million, $ 0.2 million and $ 0.5 million, respectively.
Stock Repurchase Program
In March 2025, the Company's Board of Directors approved a stock repurchase program effective March 21, 2025, whereby the Company may purchase up to $ 40.0 million in shares of its common stock over a period of up to two years. The amount and timing of share repurchases under the program may be carried out at the discretion of the Company's management through various methods in compliance with applicable state and federal laws. For the year ended December 31, 2025, 5.3 million shares, totaling $ 15.0 million , were purchased and retired.
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12. BUSINESS SEGMENT INFORMATION:
The Company is organized on the basis of products and services into a single reportable segment. All products and services reside under the same reporting hierarchy. The Company's reportable segment derives its revenues from the sale of diagnostics products and sample management solutions, as described in Note 2 Summary of Significant Accounting Policies. As the Company has only one reportable segment, there are no inter-segment sales or transfers.
The Company's Chief Operating Decision Maker ("CODM") is its Chief Executive Officer. The CODM uses consolidated net income (loss) as reported in the consolidated statement of operations as the primary measure of the reportable segment's profit or loss. The CODM uses consolidated net income (loss) to assess the performance of the segment and make decisions about resource allocation. Consolidated gross profit and consolidated operating income (loss), as reported in the consolidated statement of operations, are also used by the CODM as measures of segment profit or loss. The CODM uses gross profit to assess the impact of the Company's efforts to achieve manufacturing efficiencies and consolidate its production activities. The CODM uses operating income (loss) to assess the impact of the Company's recent restructurings, reduction in workforce, and efforts to streamline its operations to achieve cost savings. The CODM uses consolidated total assets as the measure of segment assets, as reported on the consolidated balance sheet.
The accounting policies of the Company's reportable segment are the same as those described in Note 2 Summary of Significant Accounting Policies.
The following table represents total long-lived assets by geographic area:
December 31,
2025 2024
United States $ 36,254 $ 40,286
United Kingdom 10,061 12,849
Canada 4,642 5,468
Other regions 364 89
$ 51,321 $ 58,692
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The following table represents reported segment revenues, segment profit (loss), and significant segment expenses:
For the Years Ended December 31,
2025 2024 2023
Net revenues $ 115,021 $ 185,827 405,472
Cost of products and services sold (3)
66,823 106,437 233,820
Gross profit 48,198 79,390 171,652
Research and development (3)
42,528 26,047 33,728
Sales and marketing (3)
26,117 30,986 36,319
General and administrative (3)
47,677 46,215 58,191
Loss on impairments — 4,392 10,829
Change in the estimated fair value of acquisition-related contingent consideration 4,570 — ( 99 )
Gain on sale of assets ( 725 ) — —
Operating (loss) income ( 71,969 ) ( 28,250 ) 32,684
Other income (expense) (1)
229 ( 380 ) 17,836
Interest revenue 8,078 11,469 5,862
Other segment items (2)
( 924 ) 1,160 ( 124 )
(Loss) income before income taxes and equity investment ( 64,586 ) ( 16,001 ) 56,258
Income tax expense 1,801 1,799 2,603
Loss on equity investment ( 2,344 ) ( 1,700 ) —
Net (loss) income $ ( 68,731 ) $ ( 19,500 ) $ 53,655
(1) Includes $ 12.8 million of excess profits recognized on government contracts in 2023.
(2) Includes interest expense and foreign currency gains (losses).
(3) The following tables represent additional significant segment expense categories:
For the Years Ended December 31,
2025 2024 2023
Stock-based Compensation
Cost of products and services sold $ 707 734 564
Research and development 1,046 839 1,159
Sales and marketing 863 1,129 1,181
General and administrative 7,531 9,218 7,826
$ 10,147 $ 11,920 $ 10,729
For the Years Ended December 31,
2025 2024 2023
Depreciation and Amortization
Cost of products and services sold $ 4,527 $ 6,343 $ 15,311
Research and development 2,081 1,029 1,208
Sales and marketing 80 189 571
General and administrative 3,504 3,311 3,846
$ 10,192 $ 10,872 $ 20,936
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13. BUSINESS COMBINATIONS:
BioMedomics
On November 12, 2025, the Company acquired all of the outstanding stock of BioMedomics, pursuant to the terms of an acquisition agreement (the "Acquisition Agreement"). The Company began operating this entity as of the November 12, 2025 closing date.
The primary reason for the acquisition of BioMedomics was to expand the Company's diagnostic portfolio by adding SickleSCAN ® , a rapid, point-of-need test for sickle cell disease that is sold outside of the United States.
The initial aggregate purchase price of this transaction was funded with cash on hand as shown in the table below:
Cash paid to BioMedomics $ 2,865
Transaction expenses 403
Debt paid off 330
Earnout contingent consideration 325
Expense fund 40
Initial aggregate purchase price $ 3,963
Pursuant to the Acquisition Agreement, the Company agreed to pay up to $ 5.0 million of contingent consideration based on the achievement of sales thresholds before December 31, 2031 as defined in Acquisition Agreement. The acquisition-date fair value of the earnout contingent consideration was $ 0.3 million. The range of outcome for the earnout contingent consideration is zero to $ 5.0 million.
During the year ended December 31, 2025, the Company incurred a total of $ 0.5 million of acquisition related costs, including accounting, legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2025.
The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:
Assets Acquired
Other current and non current assets $ 10
Inventory 284
Operating right-of-use assets 120
Developed technology intangible asset 1,900
Goodwill 1,775
Total assets acquired 4,089
Liabilities Assumed
Accounts payable 34
Current liabilities 17
Deferred revenue 72
Operating lease liability 120
Total liabilities assumed 243
Net Assets Acquired 3,846
Estimated fair value of contingent consideration ( 233 )
Net Cash Paid (net of cash acquired of $ 25 )
$ 3,613
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The purchase price was allocated to the tangible assets and identifiable intangible asset acquired and liabilities assumed based on their acquisition-date estimate fair values. The identifiable intangible asset was developed technology. The developed technology was all assigned a ten year useful life.
The Company, with the assistance of an independent valuation specialist, assessed the fair value of the intangible asset and contingent consideration of BioMedomics. The fair values recorded as of November 12, 2025 are based on significant inputs that are not observable in the market and thus represent a fair value measurement categorized within Level 3 of the fair value hierarchy.
The fair value of the acquired developed technology was determined using the multi-period excess earnings method, which required judgment in estimating appropriate cashflows, discount rate, survival factor, and remaining useful life.
The fair value of the earnout contingent consideration was determined using the Monte Carlo simulation model, which require judgment in estimating expected revenue, volatility, expected discount rate and risk-free interest rate.
Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition. The Company believes the goodwill related to the acquisition was a result of BioMedomics providing a product that will enable the Company to leverage the products with existing and new customers. The goodwill is not deductible for income tax purposes.
The Company continues to evaluate the fair value of assets acquired and liabilities assumed. Additional information, which existed as of the acquisition date, but was at that time unknown to the Company, may become known during the remainder of the measurement period. Changes to amounts recorded as a result of the final determination may result in a corresponding adjustment to these assets and liabilities, including goodwill. The determination of the estimated fair values of all assets acquired is expected to be completed within one year from the date of acquisition.
Revenues from BioMedomics consist of sales from the SickleSCAN ® test. Effective as of November 12, 2025, the financial results of BioMedomics are included in the consolidated financial results of the Company. BioMedomics contributed $ 0.1 million and $ 1.1 thousand of revenue and net income, respectively, to the consolidated statement of operations for the year ended December 31, 2025.
Unaudited Pro Forma Financial Information
The unaudited pro forma results presented below include the results of the BioMedomics acquisition as if it had been consummated as of January 1, 2024. The unaudited pro forma results include, amortization of the acquired intangible assets, stock compensation, and lease expense adjustments to income before income taxes but do not include changes in the fair value of the Company's contingent consideration obligations. Material nonrecurring charges, directly attributable to the transactions, including direct acquisition costs, are also excluded. In addition, the unaudited pro forma results do not include any expected benefits of the acquisitions. Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisitions been consummated as of January 1, 2024.
For the Years Ended December 31,
2025 2024
Net revenues $ 115,797 $ 187,041
Net loss
$ ( 68,964 ) $ ( 20,889 )
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Sherlock Biosciences
On December 19, 2024, the Company acquired all of the outstanding stock of Sherlock, pursuant to the terms of a merger agreement (the "Merger Agreement"). The Company began operating this entity as of the December 19, 2024 closing date.
The primary reason for the acquisition was Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is in clinical studies and was submitted to the FDA in late 2025. Subject to regulatory approvals, this test is expected to expand the Company's portfolio for rapid diagnostics for sexually transmitted infections.
The initial aggregate purchase price of this transaction was funded with cash on hand as shown in the table below:
Milestone contingent consideration $ 15,910
Royalty based contingent consideration 7,000
Cash paid to Sherlock 5,000
Legal expenses 389
Insurance policy expense 50
Initial aggregate purchase price $ 28,349
Pursuant to the Merger Agreement, the Company agreed to pay up to $ 20.0 million of contingent consideration based on the achievement of a regulatory milestone on or before December 31, 2026 as defined in the Merger Agreement. The acquisition-date fair value of the milestone contingent consideration was $ 15.9 million. The range of outcome for the milestone contingent consideration is zero to $ 20.0 million. There is also a mid-single digits quarterly royalty fee based on future sales until 2034 as defined in the Merger Agreement, the fair value of which was determined as part of the contingent consideration. The estimated acquisition-date fair value of the royalty fee acquisition-related contingent consideration was $ 7.0 million. The range of outcome for the royalty payment cannot be determined due to the fact it is based on future sales associated with the acquired in-process research and development technology through 2034 and thus does not have an upper limit.
During the year ended December 31, 2024, the Company incurred a total of $ 1.0 million of acquisition related costs, including accounting, legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2024.
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The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:
Assets Acquired
Other current assets $ 2,570
Property, plant, and equipment, net 9,244
Other noncurrent assets 462
Operating right-of-use assets 4,080
In-process research and development technology intangible asset 17,000
Goodwill 6,382
Total assets acquired 39,738
Liabilities Assumed
Accounts payable 2,449
Current liabilities 3,621
Deferred revenue 1,641
Operating lease liability 4,080
Total liabilities assumed 11,791
Net Assets Acquired 27,947
Estimated fair value of contingent consideration ( 22,910 )
Net Cash Paid (net of cash acquired of $ 402 )
$ 5,037
The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their acquisition-date estimate fair values. The identifiable intangible assets included in-process research and development technology ("IPR&D Technology"), which is an indefinite lived asset.
The Company, with the assistance of an independent valuation specialist, assessed the fair value of the assets and contingent consideration of Sherlock. The income approach was used to value the acquired intangibles, and the fair value measurements were primarily based on significant inputs that are not observable in the market and are considered Level 3 fair value measurements. The income approach estimates fair value for an asset based on the present value of cash flows projected to be generated by the asset. Projected cash flows are discounted at a required rate of return that reflects the relative risk of achieving the cash flows and the time value of money.
The regulatory milestone scenario based model was used to value the assumed milestone contingent consideration, and the fair value measurements were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements. The regulatory milestone scenario based model estimates fair value for contingent consideration based on the probability of on the achievement of a certain milestone as defined under the agreements and the discount rate.
The income approach was used to value the royalty based contingent consideration, and the fair value measurements were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements. The fair value of contingent payments approach was primarily based on projected cash flows, probability of on the achievement of a regulatory milestone as defined under the agreements, and discount rate.
Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition. The Company believes the goodwill related to the acquisition was a result of Sherlock providing a product offering that will enable the Company to leverage those products with existing and new customers. The goodwill is not deductible for income tax purposes.
The Company has completed the fair value of the assets acquired and liabilities assumed.
Revenues from Sherlock primarily consist of grant revenues for research and development purposes. Effective as of December 19, 2024, the financial results of Sherlock are included in the consolidated financial results of the Company.
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Unaudited Pro Forma Financial Information
The unaudited pro forma results presented below include the results of the Sherlock acquisition as if it had been consummated as of January 1, 2023. The unaudited pro forma results include depreciation of the acquired property plant and equipment and the estimated tax effect of adjustments to income before income taxes, but do not include changes in the fair value of the Company's contingent consideration obligations. Material nonrecurring charges, directly attributable to the transactions, including direct acquisition costs, are also excluded. In addition, the unaudited pro forma results do not include any expected benefits of the acquisitions. Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisitions been consummated as of January 1, 2023.
For the Years Ended December 31,
2024 2023
Net revenues $ 188,126 $ 406,381
Net income loss $ ( 41,459 ) $ 7,992
14. CONTINGENCIES:
Collaborations
Sherlock has active third-party license agreements entered into in order to advance and obtain technologies and services related to the business. Under these licenses, the Company is required to make up to $ 3.8 million of cash payments upon the achievement of certain scientific and commercial milestones as well as low single digit royalty payments on product sales. The Company has the right to terminate the licenses.
Litigation
From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on the Company's future financial position or results of operations.
On November 14, 2024 the Company filed a complaint against NowDiagnostics, Inc. ("NowDx"), Jody Berry ("Berry") and Janean Young ("Young") in the United States District Court for the Eastern District of Pennsylvania alleging misappropriation and misuse of the Company's proprietary information and trade secrets by NowDx, Berry and Young in violation of the Federal Defend Trade Secrets Act and the Pennsylvania Uniform Trade Secrets Act. The complaint also alleges breach of contract and duty of loyalty by Young, unfair competition by NowDx, and tortious interference with contractual relations by Berry and NowDx. NowDx filed Counterclaims against the Company on January 13, 2025 and the Company filed its Answer to the Counterclaims on February 3, 2025. Young filed a Motion to Dismiss the claims against her, which was denied by the court on February 4, 2025. NowDx, Berry, and Young agreed to a preliminary injunction which the Court entered on February 27, 2025. The case is currently in the discovery phase and the schedule for any further proceedings is currently pending.
15. RETIREMENT PLANS:
Substantially all of the Company's U.S. employees are eligible to participate in the OraSure Technologies, Inc. 401(k) Plan (the “401(k) Plan”). The 401(k) Plan permits voluntary employee contributions to be excluded from an employee’s current taxable income under provisions of Internal Revenue Code Section 401(k) and the regulations thereunder. The 401(k) Plan also provides for the Company to match employee contributions up to $ 4.0 thousand per year. The Company contributed $ 1.1 million, $ 1.2 million and $ 1.6 million to the 401(k) Plan, net of forfeitures, in 2025, 2024, and 2023, respectively.
In addition to the Company's 401(k) plan, the Company offers a nonqualified deferred compensation plan to permit eligible directors and highly compensated employees of the Company to defer receipt and taxation of their compensation each year. The Company also may make discretionary contributions to the accounts of the participating employees in any amount either in cash or stock. Participants in the plan may not purchase OraSure stock as an investment vehicle. As of December 31, 2025 and 2024, the value of the assets associated with this plan was $ 0.5 million and $ 0.7 million, respectively, and is included in other current assets and other noncurrent assets in the Company's consolidated balance sheets. The Company's obligation related to the deferred compensation plan is included in accrued expenses and other
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noncurrent liabilities in the Company's consolidated balance sheets. As of December 31, 2025 and 2024, the Company's total obligation under this plan was $ 0.5 million and $ 0.7 million, respectively.
Substantially all regular full-time Canadian employees are eligible to participate in the DNA Genotek Registered Retirement Savings Plan (the “RRSP”). The RRSP permits voluntary employee contributions to be excluded from an employee’s current taxable income and receive tax-preferred treatment with Canada Revenue Agency. The RRSP also provides for DNAG to match employee contributions up to $ 4.0 thousand CAD per year. The Company contributed $ 0.3 million, $ 0.4 million and $ 0.4 million to the RRSP in 2025, 2024, and 2023, respectively.
Substantially all British employees are eligible to participate in the People's Pension Plan (the “PPP”). The PPP permits voluntary employee contributions which may be excluded from an employee’s current taxable income and receive tax-preferred treatment with HM Revenue and Customs. The PPP also provides for the Company to match employee contributions. The Company contributed $ 0.1 million to the PPP in 2025.
16. SUBSEQUENT EVENTS:
In February 2026, the Company terminated certain non-production employees, which was less than 10 % of its work force. The termination was to align the Company's cost structure.
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