ORASURE TECHNOLOGIES INC 10-K

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 and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2024. Based on that evaluation, the Company’s management, including such officers, concluded that as of December 31, 2024 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, 2024. 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 Company acquired Sherlock Biosciences, Inc. and its wholly owned subsidiaries om December 19, 2024, and management excluded from its assessment of the effectiveness of the Company's internal control over financial reporting as of December 31, 2024, the acquired company representing approximately 4% of total assets, excluding intangible assets and goodwill related to the acquisition and 0% of total revenue of the Company as of and for the year ended December 31,2024. Management plans to fully integrate the operations of these businesses into the assessment of the effectiveness of the Company's internal control over financial reporting in 2025. The effectiveness of the Company's internal control over financial reporting as of December 31, 2024 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, 2024 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. 68 Table of Contents Opinion on Internal Control Over Financial Reporting We have audited OraSure Technologies, Inc. (a Delaware corporation) and subsidiaries (the "Company") as of December 31, 2024, 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, 2024, 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, 2024, and our report dated March 7, 2025 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. 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. Our audit of, and opinion on, the Company’s internal control over financial reporting does not include the internal control over financial reporting of Sherlock Biosciences, Inc., a wholly-owned subsidiary, whose financial statements reflect total assets, excluding intangible assets and goodwill related to the acquisition, and revenues constituting 4 percent and 0 percent, respectively, of the related consolidated financial statement amounts as of and for the year ended December 31, 2024. As indicated in Management’s Report, Sherlock Biosciences, Inc. was acquired during 2024. Management’s assertion on the effectiveness of the Company’s internal control over financial reporting excluded internal control over financial reporting of Sherlock Biosciences, Inc. 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 7, 2025 ITEM 9B. Other Information. a. None. 69 Table of Contents b. During the fourth quarter of the fiscal year ended December 31, 2024, no director of “officer” as defined in Rule 16a-1(f) under the Exchange Act 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. ITEM 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections Not applicable. 70 Table of Contents PART III The Company has omitted from Part III the information that will appear in its Definitive Proxy Statement for its 2025 Annual Meeting of Stockholders (the “2025 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 2025 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 2025 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 2025 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 2025 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 2025 Proxy Statement and is incorporated herein by reference. 71 Table of Contents 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. 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, 202 4 . 3.2 Second Amended and Restated Bylaws of OraSure Technologies, as of May 9, 2023, is incorporated by referenced to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. 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.* 72 Table of Contents 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 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.* 10.14 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. * 10.15 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.* 10.16 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.* 10.17 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.* 10.18 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.* 10.19 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.* 10.20 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.* 10.21 $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. 10.22 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. 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. 73 Table of Contents 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 Co mpany'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 74 Table of Contents 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 7, 2025. 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 7, 2025, 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 *MARA G. ASPINALL Director Mara G. Aspinall *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 *DAVID J. SHULKIN, M.D. Director David J. Shulkin, M.D. *By: /s/Stefano Taucer Stefano Taucer (Attorney-in-Fact) 75 Table of Contents Index to Consolidated Financial Statements Page Report of Independent Registered Public Accounting Firm ( GRANT THORNTON LLP , Philadelphia, PA , Auditor Firm ID: 248 ) F-2 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 F-1 Table of Contents 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 sheet of OraSure Technologies, Inc. (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2024, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for the year ended December 31, 2024, 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, 2024, and the results of its operations and its cash flows for the year ended December 31, 2024, 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, 2024, 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 7, 2025 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 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. 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 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 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 audit 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 audit provides 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 acquired in-process and research developed intangible asset and royalty contingent consideration in the Sherlock Biosciences, Inc. acquisition As further described in Note 14 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 contingent consideration, as defined under the merger agreement, related to, 1) achievement of a regulatory milestone associated with the acquired in-process research and development technology (“IPR&D technology”) intangible asset, and 2) royalty payments through December 31, 2034, representing a mid-single digit percentage of future revenues associated with the IPR&D technology intangible asset. Approximately $17.0 million of the initial purchase consideration was allocated to the IPR&D technology intangible asset. The estimated fair value of the royalty based contingent consideration was $7.0 million. We identified the fair value determinations of the IPR&D technology intangible asset and royalty based contingent consideration as a critical audit matter. F-2 Table of Contents The principal consideration for our determination that the fair value of the IPR&D technology intangible asset and 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 evaluate management’s significant assumptions, including (i) future expected revenues and cash flows and (ii) discount rates. Further, changes in these assumptions and judgments could have a significant impact on the recorded fair values. Our audit procedures related to the fair value of the IPR&D technology and 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 and cash flows 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 7, 2025 F-3 Table of Contents 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 balance sheet of OraSure Technologies, Inc. and subsidiaries (the Company) as of December 31, 2023, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the two-year period 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 financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for each of the years in the two-year period 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 audits. We are a public accounting firm registered with the Public 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 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 consolidated 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 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 audits 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 audits provide 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 13, as to which the date is March 7, 2025 F-4 Table of Contents ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands, except per share amounts) December 31, 2024 December 31, 2023 ASSETS Current Assets: Cash and cash equivalents $ 267,763 $ 290,407 Accounts receivable, net of allowance for doubtful accounts of $ 774 and $ 1,216 23,816 40,171 Inventories 34,197 47,614 Prepaid expenses 3,956 6,041 Other current assets 3,488 2,226 Total current assets 333,220 386,459 Noncurrent Assets: Property, plant and equipment, net of accumulated depreciation 45,105 45,420 Operating right-of-use assets, net 13,442 12,270 Finance right-of-use assets, net 145 576 Intangible assets, net of accumulated amortization 17,435 1,206 Goodwill 40,330 35,696 Investment in equity method investee 28,300 — Deferred tax asset 156 — Other noncurrent assets 1,526 1,218 Total noncurrent assets 146,439 96,386 TOTAL ASSETS $ 479,659 $ 482,845 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $ 8,173 $ 13,151 Deferred revenue 2,961 1,559 Accrued expenses and other current liabilities 20,179 22,710 Finance lease liability 41 539 Operating lease liability 2,129 1,577 Total current liabilities 33,483 39,536 Noncurrent Liabilities: Finance lease liability 113 226 Operating lease liability 12,321 11,162 Acquisition-related contingent consideration obligation 22,910 — Other noncurrent liabilities 494 696 Deferred income taxes — 554 Total noncurrent liabilities 35,838 12,638 TOTAL LIABILITIES 69,321 52,174 Commitments and contingencies (Note 15) STOCKHOLDERS' EQUITY Preferred stock, par value $ .000001 , 25,000 shares authorized, none issued — — Common stock, par value $ .000001 , 120,000 shares authorized, 74,598 and 73,528 shares issued and outstanding — — Additional paid-in capital 538,129 529,543 Accumulated other comprehensive loss ( 24,360 ) ( 14,941 ) Accumulated deficit ( 103,431 ) ( 83,931 ) Total stockholders' equity 410,338 430,671 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 479,659 $ 482,845 See accompanying notes to the consolidated financial statements. F-5 Table of Contents ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) For the Years Ended December 31, 2024 2023 2022 NET REVENUES: Products and services $ 184,611 $ 402,222 $ 378,047 Other 1,216 3,250 9,432 185,827 405,472 387,479 COST OF PRODUCTS AND SERVICES SOLD 106,437 233,820 239,041 Gross profit 79,390 171,652 148,438 OPERATING EXPENSES: Research and development 26,047 33,728 36,237 Sales and marketing 30,986 36,319 49,238 General and administrative 46,215 58,191 68,206 Loss on impairments 4,392 10,829 17,101 Change in the estimated fair value of acquisition-related contingent consideration — ( 99 ) ( 188 ) 107,640 138,968 170,594 Operating (loss) income ( 28,250 ) 32,684 ( 22,156 ) OTHER INCOME 12,249 23,574 6,481 (Loss) Income before income taxes ( 16,001 ) 56,258 ( 15,675 ) INCOME TAX EXPENSE 1,799 2,603 1,458 LOSS ON EQUITY INVESTMENT ( 1,700 ) — — NET (LOSS) INCOME $ ( 19,500 ) $ 53,655 $ ( 17,133 ) (LOSS) INCOME PER SHARE: BASIC $ ( 0.26 ) $ 0.73 $ ( 0.24 ) DILUTED $ ( 0.26 ) $ 0.72 $ ( 0.24 ) SHARES USED IN COMPUTING (LOSS) INCOME PER SHARE: BASIC 74,434 73,348 72,505 DILUTED 74,434 74,389 72,505 See accompanying notes to the consolidated financial statements. F-6 Table of Contents ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (in thousands) For the Years Ended December 31, 2024 2023 2022 NET (LOSS) INCOME $ ( 19,500 ) $ 53,655 $ ( 17,133 ) OTHER COMPREHENSIVE (LOSS) INCOME Currency translation adjustments ( 9,419 ) 3,274 ( 8,572 ) Unrealized gain on marketable securities — 220 214 COMPREHENSIVE (LOSS) INCOME $ ( 28,919 ) $ 57,149 $ ( 25,491 ) See accompanying notes to the consolidated financial statements. F-7 Table of Contents ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY For the Years Ended December 31, 2024, 2023 and 2022 (in thousands) Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Shares Amount Balance at January 1, 2022 72,069 $ — $ 511,063 $ ( 10,077 ) $ ( 120,453 ) $ 380,533 Common stock issued upon exercise of options 2 — 15 — — 15 Vesting of restricted stock and performance stock units 992 — — — — — Purchase and retirement of common shares ( 329 ) — ( 2,254 ) — — ( 2,254 ) Stock-based compensation — — 11,622 — — 11,622 Net loss — — — — ( 17,133 ) ( 17,133 ) Currency translation adjustments — — — ( 8,572 ) — ( 8,572 ) Unrealized gain on marketable securities — — — 214 — 214 Balance at December 31, 2022 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 See accompanying notes to the consolidated financial statements. F-8 Table of Contents ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) For the Years Ended December 31, 2024 2023 2022 OPERATING ACTIVITIES: Net (loss) income $ ( 19,500 ) $ 53,655 $ ( 17,133 ) Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities Stock-based compensation 11,920 10,729 11,622 Depreciation and amortization 10,872 20,936 15,308 Loss on impairments 4,392 10,829 17,101 Other non-cash amortization ( 564 ) 3 228 Provision for credit losses 71 ( 462 ) ( 1,032 ) Unrealized foreign currency (gain) loss ( 263 ) 103 ( 161 ) Interest expense on finance leases 22 51 94 Loss on equity investment 1,700 — — Deferred income taxes ( 657 ) 102 ( 1,651 ) Loss on sale of fixed assets 563 — 729 Change in the estimated fair value of acquisition-related contingent consideration — ( 99 ) ( 188 ) Payment of acquisition-related contingent consideration — ( 19 ) — Changes in assets and liabilities: Accounts receivable 15,872 31,116 ( 25,162 ) Inventories 13,096 48,228 ( 43,274 ) Prepaid expenses and other assets 4,089 ( 2,499 ) ( 7,091 ) Accounts payable ( 7,577 ) ( 26,976 ) 2,634 Deferred revenue ( 219 ) ( 730 ) ( 596 ) Accrued expenses and other liabilities ( 6,443 ) ( 3,384 ) 1,370 Net cash provided by (used in) operating activities 27,374 141,583 ( 47,202 ) INVESTING ACTIVITIES: Purchases of short-term investments ( 53,244 ) ( 74,652 ) ( 22,873 ) Purchase of equity method investee ( 30,000 ) — — Proceeds from maturities and redemptions of short-term investments 53,052 102,440 47,415 Acquisition of business, net of cash acquired ( 5,037 ) — — Proceeds from sale of assets — — 121 Purchases of property and equipment ( 3,797 ) ( 5,802 ) ( 6,774 ) Purchase of property and equipment under government contracts — ( 4,501 ) ( 57,135 ) Proceeds from funding under government contract — 48,669 60,331 Net cash (used in) provided by investing activities ( 39,026 ) 66,154 21,085 FINANCING ACTIVITIES: Cash payments for lease liabilities ( 842 ) ( 1,345 ) ( 1,381 ) Proceeds from exercise of stock options 214 269 15 Payment of acquisition-related contingent consideration — ( 46 ) ( 208 ) Repurchase of common stock ( 3,548 ) ( 1,901 ) ( 2,254 ) Net cash used in financing activities ( 4,176 ) ( 3,023 ) ( 3,828 ) EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH ( 6,816 ) 1,713 ( 2,837 ) NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS ( 22,644 ) 206,427 ( 32,782 ) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 290,407 83,980 116,762 CASH AND CASH EQUIVALENTS, END OF PERIOD $ 267,763 $ 290,407 $ 83,980 See accompanying notes to the consolidated financial statements. F-9 Table of Contents ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (in thousands, except per share amounts, unless otherwise indicated) 1. THE COMPANY: OraSure Technologies transforms health through actionable insight by powering the shift that connects 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 COVID-19, HIV and Hepatitis C, and Syphilis 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 is expected to be 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"), and Sherlock Biosciences, Inc. ("Sherlock"). 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. 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. Supplemental Cash Flow Information The Company paid income tax of $ 1.8 million in 2024, and received income tax refunds of $ 4.9 million in 2023 and paid income tax of $ 9.4 million in 2022. The Company had account receivable write-offs of $ 0.5 million, $ 0.7 million, and $ 2.3 million in 2024, 2023, and 2022, respectively. As of December 31, 2024, 2023 and 2022, the Company had accruals for purchases of property and equipment of $ 0.5 million, $ 0.2 million and $ 0.2 million, respectively. F-10 Table of Contents The Company acquired Sherlock in exchange for contingent consideration of $ 22,910 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 gain and losses, if any, reported in stockholders' equity as a component of 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, 2024 and 2023. The Company maintains cash balances in the United States in excess of the federally insured limits Fair Value of Financial Instruments As of December 31, 2024 and 2023, 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. December 31, Level 2024 2023 Guaranteed investment certificates 1 $ 66,584 $ 71,698 Contingent consideration 3 $ 22,910 $ — Included in cash and cash equivalents at December 31, 2024 and 2023 was $ 66.6 million and $ 71.7 million, respectively, invested in guaranteed investment certificates. Included in cash and cash equivalents at December 31, 2024 and 2023, was $ 118.5 million and $ 112.7 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, 2024 and 2023 was $ 0.7 million and $ 0.8 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 F-11 Table of Contents 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 further discussed in Note 14, 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 two different tranches: milestone payments and royalty 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 are 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 developed intangible asset. There were no changes in fair value from date of acquisition to December 31, 2024. F-12 Table of Contents Equity Method Investee In January 2024, the Company lead 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 sample management solutions to the Company's customers globally. As of December 31, 2024, 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, which coincides with the availability of its financial information. The investment in Sapphiros of $ 28.3 million as of December 31, 2024 is included in the investment in equity method investee line of the Company's balance sheet and is measured as a Level 3 investment. 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, 2024 financial statements, the Company considered whether the carrying value of the investment in Sapphiros was impaired and concluded that no such impairment existed. There was no similar investment as of December 31, 2023. 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, 2024 2023 2022 Accounts receivable $ 23,816 $ 40,171 $ 70,797 Allowance for doubtful accounts $ 774 $ 1,216 $ 2,365 Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, 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 unidentified scrap or spoilage based on historical write-off rates. 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 • 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. F-13 Table of Contents 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 Notes 5 and 6 for discussion of property, plant and equipment and intangible asset impairments, respectively, recorded for the years ended December 31, 2024 and 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 its the annual impairment assessment to November 30, to better align with the Company's annual forecasting process. On November 30, 2024, the Company performed a quantitative goodwill impairment test which concluded that the carrying value of the Company's goodwill was below its fair value indicating there was no impairment. 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 ® In-Home HIV 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. F-14 Table of Contents 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. 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. Research and development grant revenue is recognized pursuant to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance ("IAS 20") . 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. 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, 2024 and 2023 included customer prepayments of $ 3.0 million and $ 1.2 million, respectively. 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, 2024. Revenue recognized during the years ended December 31, 2024 and 2023 was $ 3.7 million and $ 2.6 million, respectively, which was included in the beginning period deferred revenue. December 31, 2024 2023 2022 Deferred revenue $ 2,961 $ 1,559 $ 2,273 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. 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. F-15 Table of Contents Revenues by product . The following table represents total net revenues by product line: For the Years Ended December 31, 2024 2023 2022 HIV $ 60,804 $ 60,823 $ 38,812 Sample Management Solutions (1) 51,046 54,274 63,342 COVID-19 (2) 45,172 257,779 243,325 HCV 14,024 12,871 13,369 Risk Assessment Testing (3) 8,354 9,736 10,269 Other product and services revenues (4) 3,506 2,265 1,634 Molecular Services 1,705 4,474 7,296 Net product and services revenues 184,611 402,222 378,047 Non-product and services revenues (5) 1,216 3,250 9,432 Net revenues $ 185,827 $ 405,472 $ 387,479 (1) Includes Genomics, Microbiome and Colli-Pee product revenues. (2) Includes COVID-19 Diagnostics and COVID-19 Molecular Products revenues. (3) Includes substance abuse testing product revenues. (4) Includes Syphilis 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, 2024 2023 2022 United States $ 139,161 $ 361,660 $ 350,206 Africa 32,745 29,254 18,152 Europe 8,424 8,111 11,536 Other regions 5,497 6,447 7,585 $ 185,827 $ 405,472 $ 387,479 Customer concentrations. The following table represents customer concentration risk: For the Years Ended December 31, 2024 2023 Revenue Concentration Non-commercial customer (1) 24 % 63 % December 31, Accounts Receivable 2024 2023 Commercial customer 10 % N/A Non-commercial customer (1) N/A 40 % (1) Same non-commercial customer. 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. F-16 Table of Contents 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 2024, 2023, and 2022, the Company incurred $ 0.5 million, $ 1.6 million, and $ 4.8 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. 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. 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 $ 1.2 million, $( 0.1 ) million, and $ 1.6 million for the years ended December 31, 2024, 2023, and 2022, 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 F-17 Table of Contents 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, 2024 2023 2022 Net income (loss) $ ( 19,500 ) $ 53,655 $ ( 17,133 ) Weighted average shares of common stock outstanding: Basic 74,434 73,348 72,505 Dilutive effect of stock options, restricted stock, and performance stock units — 1,041 — Diluted 74,434 74,389 72,505 Earnings per share: Basic $ ( 0.26 ) $ 0.73 $ ( 0.24 ) Diluted $ ( 0.26 ) $ 0.72 $ ( 0.24 ) For the year ended December 31, 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 896 shares 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. For the year ended December 31, 2022, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 436 shares were excluded from the computation of diluted loss per share. 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. Changes in accumulated other comprehensive loss by component is listed below: Foreign Currency Total Balance at December 31, 2023 $ ( 14,941 ) $ ( 14,941 ) Other comprehensive loss ( 9,419 ) ( 9,419 ) Balance at December 31, 2024 $ ( 24,360 ) $ ( 24,360 ) Recent Accounting Pronouncements 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), Scope Application of Profits Interest and Similar Awards . 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 F-18 Table of Contents 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 is evaluating the impact on the Company's consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures . The purpose of the update was to improve financial reporting by requiring disclosures of incremental segment information on an annual and interim basis for all public entities to enable investors to develop more decision-useful financial analyses. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted and require retrospective application to all periods presented in the consolidated financial statements. The Company has adopted the amendments for the year ended December 31, 2024. 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 is evaluating the impact on the Company's consolidated financial statements. Immaterial Correction of Errors In the first quarter of 2023, the Company identified an immaterial error that was corrected in its consolidated financial statements. Inventories, accounts payable and cost of products and services were reduced by $ 0.5 million, $ 1.3 million and $ 0.8 million, respectively, as of and for the year ended December 31, 2022 to correct for the accounting of a vendor rebate earned in 2022. Furthermore, stockholder's equity at December 31, 2022 increased $ 0.8 million to reflect the reduction in cost of products and services sold. The tax impact of the vendor rebate was negligible. This correction was deemed to be immaterial to the consolidated financial statements as of and for the year ended December 31, 2022. The respective operating activities on the consolidated statement of cash flows for the year ended December 31, 2022 have also been adjusted. 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 year ended December 31, 2024. The Company recognized $ 2.8 million and $ 2.2 million of such income during the years ended December 31, 2023 and 2022, respectively . 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 F-19 Table of Contents recognized no such costs during the year ended December 31, 2024. The Company recognized $ 2.0 million and $ 1.4 million of such costs during the years ended December 31, 2023 and 2022, respectively. 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, 2024 2023 Raw materials $ 17,001 $ 20,727 Work in process 420 1,900 Finished goods 16,775 24,987 $ 34,197 $ 47,614 During the years ended December 31, 2024, 2023, and 2022, the Company recorded adjustments to inventory which had a cost of $ 2.6 million, $ 8.9 million, and $ 15.6 million, respectively. Adjustments for the year ended December 31, 2024 were primarily driven by the write down of inventory based on an estimated amount of inventory that may not be sold as the Company exits 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. Additionally, a significant portion of the Company's 2022 adjustments were related to production and tech-transfer issues associated with the Company's COVID-19 rapid test. 5. PROPERTY, PLANT AND EQUIPMENT: December 31, 2024 2023 Land $ 1,118 $ 1,118 Buildings and improvements 36,152 34,606 Machinery and equipment 51,015 64,156 Computer equipment and software 11,502 17,739 Furniture and fixtures 1,621 3,748 Construction in progress 9,615 9,196 111,023 130,563 Accumulated depreciation ( 65,918 ) ( 85,143 ) $ 45,105 $ 45,420 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 Diversigen's and Novosanis's 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. F-20 Table of Contents 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 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, 2022, the Company determined several manufacturing lines and associated supporting assets would not be utilized due to changes in forecasted demand for the products the lines are intended to produce. As a result of this decision, the Company determined that the carrying values of the equipment and supporting assets were not recoverable and recorded aggregate pre-tax asset impairment charges of $ 13.5 million for the year ended December 31, 2022. Due to the extremely specialized nature of the equipment and various market data points, the estimated fair value was zero. These charges are reported within loss on impairments in the consolidated statement of operations. 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 2024, 2023, and 2022 was $ 9.8 million, $ 17.9 million, and $ 11.7 million, respectively. 6. GOODWILL AND OTHER INTANGIBLE ASSETS: Changes in goodwill are as follows: December 31, Collection Device Reporting Unit 2024 2023 Balance as of January 1 $ 35,696 $ 35,104 Change related to foreign currency translation ( 1,754 ) 592 Balance as of December 31 33,942 35,696 Diagnostics Reporting Unit Balance as of January 1 — — Acquisition 6,388 — Balance as of December 31 6,388 — $ 40,330 $ 35,696 On November 30, 2024, 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. During 2022, the Company determined that a triggering event occurred in relation to the depressed market price of the Company's common stock and corresponding decline in the Company's market capitalization. As a result, the Company performed an interim quantitative goodwill impairment test and concluded that the carrying value of the Company's Diagnostics reporting unit exceeded its estimated fair value and the goodwill balance for that segment was fully impaired. The Company recognized a pre-tax impairment charge of $ 3.6 million during the year ended December 31, 2022, which is reported in loss on impairments in the Company's consolidated statement of operations. F-21 Table of Contents Intangible assets consist of the following: 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 14) N/A 17,000 — 17,000 $ 49,848 ( 32,413 ) 17,435 December 31, 2023 Amortization Period (Years) Gross Accumulated Amortization Net Definite Life Intangible Assets Customer relationships 10 $ 11,629 $ ( 11,629 ) $ — Patents and product rights 5 7,673 ( 7,102 ) 571 Developed technology 7 - 10 10,926 ( 10,926 ) — Trade names 5 - 15 4,626 ( 3,991 ) 635 $ 34,854 $ ( 33,649 ) $ 1,206 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 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 2024, 2023, and 2022 was $ 0.7 million, $ 2.0 million, and $ 2.3 million, respectively. F-22 Table of Contents Amortization expense for each of the five succeeding fiscal years and beyond is estimated as follows: 2025 $ 290 2026 145 2027 — 2028 — 2029 — Beyond — $ 435 7. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES: December 31, 2024 2023 Payroll and related benefits $ 11,147 $ 14,654 Professional fees 2,469 2,827 Sales tax payable 1,339 1,245 Other 5,224 3,984 $ 20,179 $ 22,710 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 (in thousands): 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. No additional expense associated with the 2023 reduction in workforce was incurred during the year ended December 31, 2024. This reduction in workforce was completed by June 30, 2024. F-23 Table of Contents 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. This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations . The charges for termination benefits included in the Company's consolidated statement of operations are as follows (in thousands): 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. 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 (in thousands): 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, 2024 the Company had $ 0.5 million accrued and had paid $ 1.2 million related to the reduction in workforce. The Company expects this reduction in workforce to be completed by September 2025. 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. 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 (in thousands): 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, 2024 the Company had $ 1.1 million accrued and had paid $ 0.1 million related to the reduction in workforce. The Company expects this reduction in workforce to be completed by January 2026. F-24 Table of Contents 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, 2024, the Company is the lessee in all lease agreements. The Company's leases have remaining lease terms of one to ten 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 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. The components of lease expense are as follows: For the Years Ended December 31, 2024 2023 2022 Operating lease cost $ 1,729 $ 2,407 $ 2,910 Variable and short-term lease cost 549 381 521 Finance lease cost: Amortization of right-of use assets 331 1,091 1,299 Interest on lease liabilities 22 51 94 Total finance lease cost 353 1,142 1,393 Total lease cost $ 2,631 $ 3,930 $ 4,824 Supplemental cash flow information related to leases is as follows: For the Years Ended December 31, 2024 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 1,901 $ 1,863 $ 2,209 Operating cash flows from financing leases 22 51 94 Financing cash flows from financing leases 842 1,345 1,381 Non-cash activity: Right-of-use assets obtained in exchange for operating lease obligations 4,086 4,363 3,963 Right-of-use assets obtained in exchange for finance lease obligations 193 334 117 F-25 Table of Contents Supplemental balance sheet information related to leases is as follows: December 31, 2024 2023 Weighted Average Remaining Lease Term Weighted-average remaining lease term — operating leases 7.57 years 8.51 years Weighted-average remaining lease term — finance leases 3.74 years 1.71 years Weighted Average Discount Rate Weighted-average discount rate — operating leases 4.44 % 3.71 % Weighted-average discount rate — finance leases 4.82 % 3.45 % As of December 31, 2024, minimum lease payments by period are expected to be as follows: Finance Operating 2025 $ 48 $ 2,559 2026 48 2,373 2027 42 2,141 2028 25 2,081 2029 6 2,020 Thereafter — 5,722 Total minimum lease payments 169 16,896 Less: imputed interest ( 15 ) ( 2,446 ) Present value of lease liabilities $ 154 $ 14,450 F-26 Table of Contents 10. INCOME TAXES: Income (loss) before income tax expense consists of the following: For the Years Ended December 31, 2024 2023 2022 United States $ ( 21,523 ) $ 61,671 $ ( 7,111 ) Foreign 5,522 ( 5,413 ) ( 8,564 ) $ ( 16,001 ) $ 56,258 $ ( 15,675 ) The components of income tax expense (benefit) are as follows: For the Years Ended December 31, 2024 2023 2022 Current Federal $ 229 $ — $ — State 111 1,896 955 Foreign 2,116 605 2,154 2,456 2,501 3,109 Deferred Federal ( 2,962 ) 13,570 ( 2,250 ) State 1,368 ( 382 ) ( 633 ) Foreign 4,365 ( 1,867 ) ( 2,617 ) 2,771 11,321 ( 5,500 ) Increase (decrease) in valuation allowance ( 3,428 ) ( 11,219 ) 3,849 ( 657 ) 102 ( 1,651 ) Total income tax expense $ 1,799 $ 2,603 $ 1,458 For the years ended December 31, 2024, 2023, and 2022 the Company recorded net foreign income tax expense of $ 1.4 million, $ 0.7 million, and $ 0.5 million, respectively. The Company's 2022 foreign income tax expense included $ 1.7 million of Canadian withholding taxes paid on the repatriation of Canadian earnings offset by a foreign income tax benefit of $ 1.2 million associated with the Company's Canadian subsidiary. For the years ended December 31, 2024, 2023, and 2022 the Company recorded U.S. federal tax expense of $ 0.2 million and state tax expense of $ 0.1 million, $ 1.9 million, and $ 1.0 million respectively. F-27 Table of Contents 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, 2024 2023 2022 Statutory U.S. federal income tax rate 21.0 % 21.0 % 21.0 % Nondeductible executive compensation ( 8.5 ) 0.5 ( 5.8 ) Impact of stock-based payment awards ( 2.3 ) ( 0.3 ) ( 5.1 ) Tax effect of foreign items ( 1.9 ) ( 0.4 ) ( 6.0 ) State income taxes, net of federal benefit ( 9.1 ) 2.0 ( 0.8 ) U.S. and foreign tax credits 1.2 1.3 3.7 Nondeductible expenses and other ( 2.4 ) 0.9 8.7 Nondeductible transaction costs ( 2.1 ) — — NOL adjustment, foreign ( 31.4 ) — — Non-controlling interests 2.2 — — Change in valuation allowance, federal and state ( 10.0 ) — — Change in valuation allowance, foreign 32.1 ( 20.4 ) ( 25.0 ) Effective tax rate ( 11.2 ) % 4.6 % ( 9.3 ) % 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, 2024 2023 Deferred tax assets (liabilities): Net operating loss carryforwards $ 55,583 $ 28,014 Inventories 2,344 2,654 Capitalized research and development costs 12,946 3,897 Accruals and reserves currently not deductible 2,754 3,324 Acquired intangible assets ( 3,981 ) ( 164 ) Depreciation and amortization ( 2,017 ) ( 3,567 ) Right-of-use assets ( 2,266 ) ( 3,010 ) Lease liabilities 2,497 3,173 Stock-based compensation 3,303 3,467 Tax credit carryforwards 4,184 3,326 Net deferred tax asset 75,347 41,114 Valuation allowance ( 75,191 ) ( 41,668 ) Net deferred tax asset (liability) $ 156 $ ( 554 ) 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, and although the Company has achieved cumulative of U.S. pre-tax earnings based on a rolling three year window the Company has not achieved a level of sustained profitability that would, in the Company's judgement, support the release of the valuation allowance. Management believes the full valuation allowance is still appropriate as of December 31, 2024 and 2023. As a result, no U.S. federal income tax benefit was recorded for the years ended December 31, 2024, 2023, and 2022. F-28 Table of Contents The Company's federal NOL carryforwards consist of $ 108.6 million from existing business along with $ 71.5 million of acquired NOL carryforwards. None of these NOL carryforwards have an expiration date. The Company's foreign NOL carryforwards consist of $ 63.0 million of acquired NOL carryforwards. These foreign NOL carryforwards do not have an expiration date. The Company's state NOL carryforwards consist of $ 33.9 million from existing business along with $ 4.0 million of acquired NOL carryforwards. The state NOL carryforwards have expirations as follows: Year of Expiration NOLs 2026 - 2040 $ 14,122 2041 - 2046 13,442 Non-Expiring 10,294 $ 37,858 The Tax Reform Act of 1986 contains provisions under Internal Revenue Code (“IRC”) Section 382 that limit the annual amount of federal and state NOL carryforwards that can be used in any given year in the 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 Sherlock. These NOL carryforwards have no expiration date. In January 2022, approximately $ 65.0 million was repatriated from the Company's Canadian subsidiary as a one-time event. Associated with this repatriation the Company paid $ 1.7 million in Canadian withholding tax which is included in the Company's foreign income tax expense within the table further above. 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, 2024. As of December 31, 2024, the Company's gross unrecognized tax benefits totaled $ 0.3 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 Company records interest and penalties related to unrecognized tax benefits as a component of income tax expense. Interest and penalties were immaterial in 2024, 2023, and 2022. 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, 2024. The reconciliation of the Company's unrecognized tax benefits is as follows: 2024 2023 2022 Balance at January 1 $ 304 $ 373 $ 805 Additions for tax positions of prior periods 29 — 1 Reductions for tax positions of prior periods — ( 69 ) ( 433 ) Balance at December 31 $ 333 $ 304 $ 373 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, 2024, 5,412 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 F-29 Table of Contents 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. 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 2024 2023 2022 Risk-free interest rate (1) 4.14 % 4.23 % 1.65 % Expected dividend yield — — — Expected stock price volatility (2) 53 % 51 % 50 % Expected life of stock options (in years) (2) 5 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, 2024, 2023, and 2022 was $ 3.68 , $ 3.24 and $ 4.15 , respectively. Compensation expense recognized in the financial statements related to stock options was $ 1.4 million, $ 1.3 million, and $ 1.5 million for the years ended December 31, 2024, 2023, and 2022, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2024, 2023, and 2022 (the amount by which the market price of the stock on the date of exercise exceeded the exercise price) was $ 38.4 thousand, $ 43.0 thousand, and $ 4.0 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, 2024 2,070 $ 9.27 Granted 595 6.99 Exercised ( 32 ) 6.70 Expired ( 188 ) 11.19 Forfeited ( 208 ) 7.20 Outstanding on December 31, 2024 2,237 $ 8.73 6.33 $ — Vested or expected to vest as of December 31, 2024 2,198 $ 8.72 6.44 $ — Exercisable on December 31, 2024 1,389 $ 9.79 4.91 $ — As of December 31, 2024, there was $ 2.6 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 $ 0.2 million, $ 0.3 million and $ 0.02 million for the years ended December 31, 2024, 2023, and 2022, 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. F-30 Table of Contents The following table summarizes information about stock options outstanding as of December 31, 2024: 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 $ 4.26 - $ 6.82 578 7.35 $ 5.98 285 $ 6.02 $ 7.13 - $ 10.69 1,277 6.51 7.89 728 8.21 $ 12.90 - $ 19.34 334 4.33 14.87 329 14.86 $ 21.64 - $ 32.46 48 2.78 $ 21.65 47 $ 21.65 2,237 6.33 $ 8.73 1,389 $ 9.79 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 $ 6.9 million, $ 7.6 million and $ 9.2 million related to restricted shares was recognized during the years ended December 31, 2024, 2023, and 2022, 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, 2024 2,521 $ 6.04 Granted 875 6.84 Vested ( 1,604 ) 5.81 Forfeited ( 98 ) 7.37 Issued and unvested, December 31, 2024 1,694 $ 6.60 Issued and expected to vest, December 31, 2024 1,694 $ 6.60 As of December 31, 2024, there was $ 6.0 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, 2024, 2023, and 2022, the Company purchased and immediately retired 617 , 262 and 241 shares with aggregate values of $ 3.4 million, $ 1.4 million and $ 1.6 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 one-year or 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. F-31 Table of Contents Compensation cost of $ 3.6 million, $ 1.8 million and $ 0.9 million related to the PSUs was recognized during the years ended December 31, 2024, 2023, and 2022, respectively. The following table summarizes PSU activity under the Stock Plan: Units Weighted- Average Grant Date Fair Value Issued and unvested, January 1, 2024 991 $ 6.52 Granted (1) 519 8.87 Performance adjustment (2) 18 N/A Vested ( 74 ) 10.99 Forfeited — — Issued and unvested, December 31, 2024 1,454 $ 7.19 Issued and expected to vest, December 31, 2024 1,454 $ 7.19 (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, 2024, there was $ 5.3 million of unrecognized compensation expense related to unvested performance stock units that is expected to be recognized over a weighted average period of 1.7 years. In connection with the vesting of performance stock units during the year ended December 31, 2024, 2023 and 2022, the Company purchased and immediately retired 23 , 86 , and 88 shares with aggregate values of $ 0.2 million, $ 0.5 million and $ 0.6 million, respectively. Share Repurchase Program On August 5, 2008, the Company's Board of Directors approved a share repurchase program pursuant to which the Company is permitted to acquire up to $ 25.0 million of the Company's outstanding common shares. No shares were purchased and retired during the years ended December 31, 2024, 2023, and 2022. 12. TRANSITION COSTS On December 31, 2021, the Company's Board of Directors approved the termination of Stephen S. Tang, the Company’s President and Chief Executive Officer, without cause under his existing employment agreement with the Company, with such termination effective as of March 31, 2022. On January 2, 2022, Dr. Tang and the Company entered into a Transition Agreement providing for the terms of the cessation of Dr. Tang’s employment with the Company, including the cessation of his service as President and Chief Executive Officer of the Company and as a member of the Board. Under the Transition Agreement, Dr. Tang’s service to the Company in all capacities ended on March 31, 2022. Pursuant to the Transition Agreement, Dr. Tang received severance of $ 1.6 million, which was accrued in the consolidated financial statements at December 31, 2021 and paid in April 2022. Additionally, in accordance with his Transition Agreement, certain of his unvested time-vesting restricted stock awards and unvested PSUs that were outstanding at March 31, 2022 vested on April 8, 2022. His remaining unvested time-vesting restricted stock awards and PSUs were forfeited on March 31, 2022. These payments, rights and benefits are substantially similar to the severance benefits contemplated by his previous employment agreement in respect to a termination without cause thereunder. In aggregate, the Company recognized $ 1.5 million of expense in relation to Dr. Tang's stock compensation for the year ended December 31, 2022. F-32 Table of Contents 13. 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. Historically, there was separate management leading the Company's Diagnostics and Molecular Solutions businesses. In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across the Diagnostics and Molecular Solutions businesses into one operating segment with sales, marketing, product development and research teams covering all product lines and reporting to a Chief Product Officer ("CPO"). 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, 2024 2023 United States $ 40,286 $ 48,311 United Kingdom 12,849 — Canada 5,468 8,777 Other regions 89 1,178 $ 58,692 $ 58,266 F-33 Table of Contents The following table represents reported segment revenues, segment profit (loss), and significant segment expenses: For the Years Ended December 31, 2024 2023 2022 Net revenues $ 185,827 $ 405,472 387,479 Cost of products and services sold (3) 106,437 233,820 239,041 Gross profit 79,390 171,652 148,438 Research and development (3) 26,047 33,728 36,237 Sales and marketing (3) 30,986 36,319 49,238 General and administrative (3) 46,215 58,191 68,206 Loss on impairments 4,392 10,829 17,101 Change in the estimated fair value of acquisition-related contingent consideration — ( 99 ) ( 188 ) Operating (loss) income ( 28,250 ) 32,684 ( 22,156 ) Other (expense) income (1) ( 380 ) 17,836 3,453 Interest revenue 11,469 5,862 1,569 Other segment items (2) 1,160 ( 124 ) 1,459 (Loss) income before income taxes ( 16,001 ) 56,258 ( 15,675 ) Income tax expense 1,799 2,603 1,458 Loss on equity investment ( 1,700 ) — — Net (loss) income $ ( 19,500 ) $ 53,655 $ ( 17,133 ) (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, 2024 2023 2022 Stock-based Compensation Cost of products and services sold $ 734 $ 564 $ 334 Research and development 839 1,159 1,128 Sales and marketing 1,129 1,181 1,702 General and administrative 9,219 7,826 8,458 $ 11,920 $ 10,729 $ 11,622 For the Years Ended December 31, 2024 2023 2022 Depreciation and Amortization Cost of products and services sold $ 6,343 $ 15,311 $ 9,230 Research and development 1,029 1,208 1,098 Sales and marketing 189 571 630 General and administrative 3,311 3,846 4,350 $ 10,872 $ 20,936 $ 15,308 F-34 Table of Contents 14. BUSINESS COMBINATIONS: 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 is Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) is in clinical studies and is expected to be submitted to the FDA for approval by the end of 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 had as shown 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 fair value of this milestone metric contingent consideration was $ 15.9 million. The range of outcome for the milestone contingent consideration is $ 0.0 million to $ 20.0 million. Also, there is a mid-single digits quarterly royalty fee based on future sales until 2034 as defined in the Merger Agreement, which was fair valued as part of 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 its 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. F-35 Table of Contents 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, 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 fair value of contingent payments approach was used to value the royalty based contingent consideration, were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements. The fair value of contingent payments approach were 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 continues to evaluate the fair value of certain 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 F-36 Table of Contents 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 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. For the year ended December 31, 2024, consolidated net revenues include revenues associated with Sherlock of $ 78.0 thousand and consolidated results from operations include a net loss of $ 255.4 thousand generated since the acquisition date. 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 F-37 Table of Contents 15. COMMITMENTS AND CONTINGENCIES: Purchase Commitments As of December 31, 2024, the Company had a manufacturing agreement with a third party vendor requiring a minimum purchase commitment. If the minimum commitment is not achieved, the Company will be required to make annual penalty payments over the next year. Based on current forecasts, these penalties aggregate to approximately $ 0.3 million and are accrued for in the consolidated balance sheet. These estimated penalties can fluctuate based on changes in forecasted demand. The table below represents an estimate of future purchases under the agreement (in thousands): 2025 $ 1,443 2026 — 2027 — 2028 — 2029 — $ 1,443 Collaborations Sherlock has an active third-party license agreement entered into in order to advance and obtain technologies and services related to the business. Under this license, the Company is required to make up to $ 2.3 million of cash payments upon the achievement of certain scientific and commercial milestones as well as low single digit royalty payments on product sales. No milestone payments have been made as of December 31, 2024. The Company has the right to terminate the license for any reason. Unless otherwise terminated, the license terminates upon the expiration of the last to expire valid claim. 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. Spectrum Patent Litigation In March 2021, the Company filed a complaint against Spectrum Solutions, LLC (“Spectrum”) in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG. Spectrum filed an answer asserting that its device does not infringe the Company’s patent and that the Company’s patent is invalid. In August 2021, the Company amended its complaint to add a second patent to this litigation. Spectrum responded to the Company's amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office (“PTO”), which was granted by the PTO. The District Court issued multiple pretrial orders, resolving the infringement, antitrust, and inequitable conduct claims without trial. First, the District Court granted Spectrum’s motion for summary judgment of noninfringement. Second, the Court denied Spectrum’s motion to supplement its allegations of alleged antitrust violations, finding that if such an amendment were allowed, Spectrum’s claims would not survive a motion for summary judgment. Spectrum thereafter withdrew its antitrust and inequitable conduct counterclaims. Spectrum did not appeal the District Court's denial of its motion to amend. The Company appealed the grant of summary judgment to the Court of Appeals on June 8, 2023. On February 14, 2025, the Court of Appeal affirmed the District Court’s judgment. The Company is considering its appellate options. On February 7, 2024, the PTO issued a Final Written Decision regarding the second patent in the litigation, holding that claims 1, 3–8, 11, and 12 of U.S. Patent No. 11,002,646 B2 are unpatentable. On March 8, 2024, the Company filed a Request for Rehearing by the Director of the PTO of the Final Written Decision. On March 27, 2024, the Company’s Request for Rehearing was denied. On September 15, 2023, Spectrum filed a separate petition for inter partes review of a third patent, which DNAG did not assert in the District Court. On March 26, 2024, the PTO issued a Decision Granting Institution of Inter Partes Review. On July 2, 2024, the Company filed a Motion to Amend the claims of the third patent and oral argument in this IPR took place on January 24, 2025. On February 19, 2025, the PTO issued a Final Written Decision regarding the third patent in the litigation, granting the Company's Motion to Amend as to cancelling the original claims, F-38 Table of Contents but denying the Company's Motion to Amend as to adding proposed substitute claims. The Company is considering its appellate options. NowDiagnostics Litigation 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. 16. 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 $ 1.2 million, $ 1.6 million and $ 1.8 million to the 401(k) Plan, net of forfeitures, in 2024, 2023, and 2022, 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, 2024 and 2023, the value of the assets associated with this plan was $ 0.7 million and $ 0.8 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 noncurrent liabilities in the Company's consolidated balance sheets. As of December 31, 2024 and 2023, the Company's total obligation under this plan was $ 0.7 million and $ 0.8 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 $ 0.4 million, $ 0.4 million and $ 0.5 million to the RRSP in 2024, 2023, and 2022, respectively. F-39