ORASURE TECHNOLOGIES INC
For the period ended Dec 31, 2024. Filed Mar 7, 2025.
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FY2024 · Filed Mar 7, 2025
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Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
OraSure Technologies, Inc.
Opinion on the financial statements
We have audited the accompanying consolidated balance 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.
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.
March 7, 2025
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.
March 11, 2024, except for Note 13, as to which the date is March 7, 2025
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