OraSure Technologies(OSUR) - 2025 Q2 - Quarterly Report

FORM 10-Q Filing Information Filing Details This document is a Quarterly Report on Form 10-Q for OraSure Technologies, Inc. for the quarterly period ended June 30, 2025, with its common stock listed on The NASDAQ Stock Market LLC - The report is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2] | Indicator | Value | | :--- | :--- | | Commission File Number | 001-16537 | | Registrant Name | ORASURE TECHNOLOGIES, INC. | | State of Incorporation | Delaware | | IRS Employer Identification No. | 36-4370966 | | Principal Executive Offices | 220 East First Street, Bethlehem, Pennsylvania 18015 | | Telephone Number | (610) 882-1820 | | Securities Registered | Common Stock, $0.000001 par value per share | | Trading Symbol | OSUR | | Exchange | The NASDAQ Stock Market LLC | | Filer Status | Accelerated filer | | Common Stock Outstanding (July 31, 2025) | 73,136,987 shares | Forward-Looking Statements Nature of Forward-Looking Statements This section clarifies that the report contains forward-looking statements regarding the Company's future financial performance, operational developments, regulatory activities, and market conditions - The report includes forward-looking statements concerning expected revenues, earnings/losses, net income (loss), expenses, cash flow, clinical trials, regulatory approvals, business transactions, and future market conditions[7] - These statements are not guarantees of future performance and involve known and unknown factors that could cause actual results to differ materially[8] Risk Factors and Disclaimers The Company identifies numerous factors that could materially affect its performance, including market acceptance, manufacturing capabilities, regulatory approvals, competition, economic conditions, and litigation - Market acceptance and ability to sell products/services - Failure of distributors or customers to meet purchase forecasts - Ability to manufacture products to specifications and comply with regulations - Ability to obtain regulatory approvals for new products or indications - Changes in relationships with strategic partners - Impact of competitors, competing products, and technology changes - Ability to fund R&D and operations - Reliance on sole supply sources for critical components - Impact of negative economic conditions, including interest rates, inflation, and capital market disruptions - Uncertainty relating to patent protection and potential infringement claims - Impact of cybersecurity incidents and other disruptions - Changes in international, federal, or state laws and regulations - Forward-looking statements are made as of the report date, and the Company undertakes no duty to update them unless required by law[9][11] - The Company has a policy against disclosing material non-public information to securities analysts or confirming financial forecasts/projections issued by others[12] PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents the unaudited consolidated financial statements of OraSure Technologies, Inc. and its subsidiaries for the periods ended June 30, 2025, and December 31, 2024, along with detailed notes Consolidated Balance Sheets The consolidated balance sheets show a decrease in total assets and stockholders' equity from December 31, 2024, to June 30, 2025, primarily driven by a reduction in cash and cash equivalents and an increase in current liabilities due to acquisition-related contingent consideration | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $234,578 | $267,763 | | Total current assets | $301,438 | $333,220 | | Total noncurrent assets | $143,597 | $146,439 | | TOTAL ASSETS | $445,035 | $479,659 | | LIABILITIES | | | | Total current liabilities | $42,350 | $33,483 | | Total noncurrent liabilities | $21,964 | $35,838 | | TOTAL LIABILITIES | $64,314 | $69,321 | | STOCKHOLDERS' EQUITY | | | | Total stockholders' equity | $380,721 | $410,338 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $445,035 | $479,659 | - Cash and cash equivalents decreased by $33.185 million from December 31, 2024, to June 30, 2025[17] - Current liabilities increased by $8.867 million, largely due to a $16.981 million current portion of acquisition-related contingent consideration[17] Consolidated Statements of Operations The Company reported a significant increase in net loss for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily driven by a substantial decrease in net revenues and an increase in operating expenses | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Revenues | $31,242 | $54,335 | $61,173 | $108,467 | | Gross Profit | $13,159 | $24,689 | $25,458 | $48,754 | | Operating Loss | $(18,026) | $(2,740) | $(35,776) | $(9,833) | | Net Loss | $(19,693) | $(615) | $(35,733) | $(4,199) | | Basic Loss Per Share | $(0.26) | $(0.01) | $(0.48) | $(0.06) | | Diluted Loss Per Share | $(0.26) | $(0.01) | $(0.48) | $(0.06) | - Net revenues decreased by 43% for the three months and 44% for the six months ended June 30, 2025, compared to the prior year[19] - Operating loss significantly widened from $(2.7) million to $(18.0) million for the three months and from $(9.8) million to $(35.8) million for the six months ended June 30, 2025[19] Consolidated Statements of Comprehensive Loss The Company reported a comprehensive loss of $(12.9) million for the three months and $(28.7) million for the six months ended June 30, 2025, which includes the net loss adjusted for currency translation gains | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $(19,693) | $(615) | $(35,733) | $(4,199) | | Currency translation adjustments | $6,751 | $(1,134) | $6,989 | $(3,690) | | Comprehensive Loss | $(12,942) | $(1,749) | $(28,744) | $(7,889) | - Currency translation adjustments resulted in a gain of $6.751 million for the three months and $6.989 million for the six months ended June 30, 2025, partially offsetting the net loss[22] Consolidated Statements of Cash Flows For the six months ended June 30, 2025, the Company experienced a net decrease in cash and cash equivalents, primarily due to cash used in operating activities and financing activities, partially offset by a positive effect from foreign exchange rate changes | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(29,956) | $14,583 | | Net cash used in investing activities | $(1,566) | $(40,865) | | Net cash used in financing activities | $(6,751) | $(3,339) | | Effect of foreign exchange rate changes on cash | $5,088 | $(2,547) | | Net decrease in cash and cash equivalents | $(33,185) | $(32,168) | | Cash and cash equivalents, end of period | $234,578 | $258,239 | - Operating activities shifted from providing $14.6 million in cash in 2024 to using $30.0 million in 2025[24] - Financing activities used $6.8 million in 2025, largely due to $5.0 million in common stock repurchases[24] Notes to the Consolidated Financial Statements These notes provide detailed information on the Company's accounting policies, financial instrument valuations, inventory, property, plant and equipment, accrued expenses, termination benefits, revenue recognition, income taxes, earnings per share, stockholders' equity, business segments, business combinations, and commitments and contingencies 1. Summary of Significant Accounting Policies This note outlines the Company's accounting principles, including consolidation, basis of presentation, and changes in accounting for inventories to the average cost method, along with policies for fair value measurements, contingent consideration, and foreign currency - Effective January 1, 2025, the Company changed its inventory valuation methodology from FIFO to the average cost method, deeming the effect immaterial[28] | Fair Value Measurement (in thousands) | Level | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | :--- | | Guaranteed investment certificates | 1 | $68,447 | $66,584 | | Contingent consideration: Current portion | 3 | $16,981 | — | | Contingent consideration: Long-term portion | 3 | $7,140 | $22,910 | | Total Contingent Consideration | | $24,121 | $22,910 | - The investment in Sapphiros, an equity method investee, was $27.0 million as of June 30, 2025, measured as a Level 3 investment[40] 2. Inventories The Company's total inventories decreased slightly from December 31, 2024, to June 30, 2025, with a notable decrease in raw materials and an increase in finished goods | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Raw materials | $15,334 | $17,002 | | Work in process | $559 | $420 | | Finished goods | $17,482 | $16,775 | | Total Inventories | $33,375 | $34,197 | 3. Property, Plant and Equipment, net Net property, plant and equipment decreased from $45.1 million at December 31, 2024, to $42.2 million at June 30, 2025, primarily due to depreciation exceeding new additions and a significant reduction in construction in progress | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Buildings and improvements | $39,076 | $36,152 | | Machinery and equipment | $57,527 | $51,015 | | Construction in progress | $1,537 | $9,615 | | Total Property, Plant and Equipment | $113,255 | $111,023 | | Accumulated depreciation | $(71,100) | $(65,918) | | Net Property, Plant and Equipment | $42,155 | $45,105 | - Construction in progress decreased significantly from $9.6 million to $1.5 million[50] 4. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities decreased from $20.2 million at December 31, 2024, to $14.4 million at June 30, 2025, with reductions across payroll, professional fees, sales tax, and other accrued amounts | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Payroll and related benefits | $9,028 | $11,147 | | Professional fees | $1,564 | $2,469 | | Sales tax payable | $1,089 | $1,339 | | Other | $2,714 | $5,224 | | Total Accrued Expenses and Other Current Liabilities | $14,395 | $20,179 | 5. Termination Benefits The Company incurred termination benefits in 2024 due to workforce reductions related to COVID-19 manufacturing, consolidation of the Novosanis site, discontinuation of Diversigen molecular services, and exiting the risk assessment business | (in thousands) | Q1 2024 Reduction in Workforce (Six Months Ended June 30, 2024) | | :--- | :--- | | Cost of products and services sold | $231 | | Research and development | $87 | | Sales and marketing | $69 | | General and administrative | $17 | | Total | $404 | | (in thousands) | Q2 2024 Reduction in Workforce (Six Months Ended June 30, 2024) | | :--- | :--- | | Cost of products and services sold | $889 | | Research and development | $478 | | Sales and marketing | $125 | | General and administrative | $160 | | Total | $1,652 | - As of June 30, 2025, the Company had $0.5 million accrued for the Q3 2024 reduction in workforce, with $0.7 million paid[56] 6. Revenues Net revenues significantly decreased for both the three and six months ended June 30, 2025, compared to 2024, primarily due to a sharp decline in COVID-19 Diagnostics revenue and Sample Management Solutions, partially offset by growth in HIV and Syphilis products | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | HIV | $14,398 | $13,652 | $27,298 | $27,032 | | Sample Management Solutions | $9,855 | $12,609 | $18,965 | $23,431 | | HCV | $4,126 | $4,734 | $8,459 | $7,734 | | Risk Assessment Testing | $446 | $2,308 | $1,866 | $4,352 | | COVID-19 | $28 | $18,939 | $489 | $42,067 | | Molecular Services | — | $810 | — | $1,683 | | Net product and services revenues | $29,847 | $53,949 | $58,844 | $107,728 | | Non-product and services revenues | $1,395 | $386 | $2,329 | $739 | | Net revenues | $31,242 | $54,335 | $61,173 | $108,467 | - COVID-19 revenues decreased by 100% for the three months and 99% for the six months ended June 30, 2025, due to fulfillment of government contracts and lower demand[57] - Non-product and services revenues increased significantly by 261% (three months) and 215% (six months) due to funded R&D contracts from the Sherlock acquisition and BARDA[57] 7. Income Taxes Income tax expense increased for both the three and six months ended June 30, 2025, primarily due to recording an uncertain tax position, while the Company maintains a full valuation allowance against its U.S. and U.K. deferred tax assets | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Federal income tax expense | $157 | — | $165 | — | | State income tax expense (benefit) | $2,394 | $3 | $2,403 | $(228) | | Foreign income tax (benefit) expense | $(551) | $378 | $(1,024) | $591 | | Total Income Tax Expense | $2,000 | $381 | $1,544 | $363 | - The increase in income tax expense is largely due to recording an uncertain tax position for certain tax matters, including penalties and interest[61] - Uncertain tax positions increased from approximately $0.0 million at December 31, 2024, to $2.5 million at June 30, 2025[64] 8. Income (Loss) Per Share Basic and diluted loss per share were the same for the periods presented due to the Company incurring a net loss, making dilutive securities anti-dilutive - Basic and diluted loss per share are identical when a net loss exists, as potential dilutive effects would be anti-dilutive[66] | Excluded Dilutive Securities (shares) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Common stock options, unvested restricted stock, and performance stock units | 581 | 1,010 | 618 | 1,333 | 9. Stockholders' Equity Total stockholders' equity decreased from $410.3 million at December 31, 2024, to $380.7 million at June 30, 2025, primarily due to the net loss and common stock repurchases, partially offset by stock-based compensation and currency translation adjustments - In March 2025, the Board authorized a stock repurchase program of up to $40.0 million over two years[69] - The Company repurchased 1.8 million shares of common stock under the program during the six months ended June 30, 2025[69] | (in thousands) | Balance at Dec 31, 2024 | Net Loss (Q2 2025) | Repurchase of Common Stock (Q2 2025) | Currency Translation Adjustments (Q2 2025) | Balance at Jun 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Total Stockholders' Equity | $410,338 | $(19,693) | $(5,000) | $6,751 | $380,721 | 10. Business Segment Information The Company operates as a single reportable segment focused on diagnostic products and sample management solutions, with long-lived assets primarily located in the United States - The Company has one reportable segment: diagnostics products and sample management solutions[72] | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Long-Lived Assets by Geographic Area | | | | United States | $38,418 | $40,286 | | United Kingdom | $11,037 | $12,849 | | Canada | $5,237 | $5,468 | | Other regions | $347 | $89 | | Total | $55,039 | $58,692 | | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net revenues | $31,242 | $54,335 | $61,173 | $108,467 | | Gross profit | $13,159 | $24,689 | $25,458 | $48,754 | | Operating (loss) income | $(18,026) | $(2,740) | $(35,776) | $58,587 | | Net loss | $(19,693) | $(615) | $(35,733) | $(4,199) | 11. Business Combinations In December 2024, the Company acquired Sherlock Biosciences to expand its rapid diagnostics portfolio, particularly for sexually transmitted infections, involving an initial cash payment and significant contingent consideration - OraSure acquired Sherlock Biosciences on December 19, 2024, primarily for its first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is in clinical studies[77][78] | Initial Aggregate Purchase Price Components | Amount (in thousands) | | :--- | :--- | | Milestone contingent consideration | $15,910 | | Royalty based contingent consideration | $7,000 | | Cash paid to Sherlock | $5,000 | | Legal expenses | $389 | | Insurance policy expense | $50 | | Total Initial Aggregate Purchase Price | $28,349 | - The acquisition included $17.0 million in-process research and development technology intangible asset and $6.4 million in goodwill[81] 12. Commitments and Contingencies The Company is involved in legal actions in the ordinary course of business, with management believing the outcomes will not have a material adverse effect on its financial position, including an ongoing lawsuit against NowDiagnostics, Inc - Management believes the outcomes of legal actions will not have a material adverse effect on the Company's future financial position or results of operations[90] - The Company filed a complaint against NowDiagnostics, Inc., Jody Berry, and Janean Young on November 14, 2024, alleging misappropriation of proprietary information and trade secrets[91] - A preliminary injunction was entered on February 27, 2025, and the trial is scheduled for March 9, 2026[91] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the Company's financial performance and condition, highlighting significant revenue declines, increased operating losses, and strategic shifts, and discusses liquidity Business Overview OraSure Technologies develops, manufactures, markets, and sells diagnostic products and specimen collection devices, including tests for HIV, Hepatitis C, Syphilis, and COVID-19, and offers sample management solutions - The Company's core business involves diagnostic products and specimen collection devices for diseases like HIV, Hepatitis C, Syphilis, and COVID-19, sold globally to various healthcare and public health organizations[94] - Sample management solutions are provided to clinical laboratories, direct-to-consumer labs, researchers, and pharmaceutical companies, including products for genomics, microbiome, and a urine collection device (Colli-Pee®)[95] Recent Developments The Company discontinued its risk assessment product line, with sales winding down in early 2025, and certain assets of this product line were sold during the first quarter of 2025 - The Company discontinued sales of its risk assessment product line in the third quarter of 2024, with completion in the second quarter of 2025[96] | Risk Assessment Product Sales (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0.4 | $2.3 | $1.9 | $4.4 | Results of Operations for the Three Months Ended June 30, 2025 compared to June 30, 2024 For the three months ended June 30, 2025, consolidated net revenues decreased significantly by 43%, primarily due to a 100% drop in COVID-19 Diagnostics revenue and a 22% decrease in Sample Management Solutions, leading to a wider operating loss | (in thousands) | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Net Revenues | $31,242 | $54,335 | (43)% | | Diagnostics | $19,222 | $18,746 | 3% | | Sample Management Solutions | $9,855 | $12,609 | (22)% | | Risk Assessment Testing | $446 | $2,308 | (81)% | | COVID-19 Diagnostics | $28 | $18,934 | (100)% | | Non-product and services revenues | $1,395 | $386 | 261% | - Consolidated gross profit margin decreased to 42.1% from 45.4%, driven by a negative product mix (lower InteliSwab® and genomics sales, higher international sales) and higher scrap expense, partially offset by improved overhead absorption[106] - Operating loss increased by $15.3 million to $(18.0) million, mainly due to lower revenues, lower gross margins, and increased R&D spend for clinical trials related to the newly acquired Sherlock companies[107][108] Results of Operations for the Six Months Ended June 30, 2025 compared to June 30, 2024 For the six months ended June 30, 2025, consolidated net revenues decreased by 44%, primarily due to a 99% reduction in COVID-19 Diagnostics and a 19% decline in Sample Management Solutions, resulting in a significantly larger operating loss | (in thousands) | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Net Revenues | $61,173 | $108,467 | (44)% | | Diagnostics | $36,911 | $35,139 | 5% | | Sample Management Solutions | $18,965 | $23,431 | (19)% | | Risk Assessment Testing | $1,866 | $4,352 | (57)% | | COVID-19 Diagnostics | $485 | $42,031 | (99)% | | Non-product and services revenues | $2,329 | $739 | 215% | - Consolidated gross profit margin decreased to 41.6% from 44.9%, attributed to a negative product mix (lower InteliSwab® and genomics sales, higher international sales) and partially offset by the termination of the microbiome molecular sequencing services business and improved overhead absorption[127] - Operating loss widened to $(35.8) million from $(9.8) million, driven by decreased revenues, lower gross margins, and a 47% increase in R&D expenses due to clinical trials for the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device and Sherlock acquisition[128][129] Liquidity and Capital Resources The Company's cash and cash equivalents decreased to $234.6 million at June 30, 2025, from $267.8 million at December 31, 2024, primarily due to cash used in operating and financing activities | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $234,578 | $267,763 | | Working capital | $259,088 | $299,737 | - Net cash used in operating activities was $30.0 million for the six months ended June 30, 2025, compared to $14.6 million provided in the prior year[139] - Net cash used in financing activities was $6.8 million, largely due to $5.0 million in common stock repurchases and $1.7 million for tax-related share repurchases[141] Critical Accounting Policies and Estimates No material changes have been made to the Company's critical accounting policies and estimates during the six months ended June 30, 2025, as detailed in its Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to critical accounting policies and estimates occurred during the six months ended June 30, 2025[144] Item 3. Quantitative and Qualitative Disclosures About Market Risk There have been no material changes in the Company's assessment of its sensitivity to market risk since the disclosures in its Annual Report on Form 10-K for the year ended December 31, 2024 - No material change in the Company's assessment of market risk sensitivity since the December 31, 2024 Annual Report on Form 10-K[145] Item 4. Controls and Procedures The Company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the three months ended June 30, 2025 - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[146] - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[147] PART II. OTHER INFORMATION Item 1. Legal Proceedings The Company is involved in various legal actions, none of which are expected to have a material adverse effect on its financial position, including an ongoing lawsuit against NowDiagnostics, Inc. for trade secret misappropriation - Management believes the outcomes of legal actions will not have a material adverse effect on the Company's future financial position or results of operations[148] - The NowDiagnostics litigation, alleging misappropriation of proprietary information and trade secrets, has a trial scheduled for March 9, 2026[149] Item 1A. Risk Factors No material changes to previously disclosed risk factors were made, except for the addition of a new risk factor concerning potential adverse effects from changes in tax laws or their implementation/interpretation, including recent legislation - A new risk factor was added regarding potential adverse effects from changes in tax laws, their implementation, or interpretation[151] - Recent legislation, the One Big Beautiful Bill Act (OBBBA), enacted on July 4, 2025, includes changes to the Internal Revenue Code that the Company is evaluating[151] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The Company repurchased 1,820,756 shares of common stock under its $40.0 million stock repurchase program during May and June 2025, with $35.0 million remaining under the program as of June 30, 2025 - The Company's Board authorized a $40.0 million stock repurchase program effective March 21, 2025[158] | Period | Total shares purchased | Average price paid per share | Shares purchased under publicly announced plans | Maximum remaining under plans | | :--- | :--- | :--- | :--- | :--- | | April 1, 2025 - April 30, 2025 | — | $— | — | $40,000,000 | | May 1, 2025 - May 31, 2025 | 1,217,912 | $2.64 | 1,187,456 | $38,000,000 | | June 1, 2025 - June 30, 2025 | 874,180 | $2.93 | 633,300 | $35,000,000 | | Total | 2,092,092 | | 1,820,756 | | - Shares were also retired to satisfy minimum tax withholdings in connection with the vesting of restricted and performance shares[154] Item 3. Defaults Upon Senior Securities The Company reported no defaults upon senior securities - No defaults upon senior securities were reported[155] Item 4. Mine Safety Disclosures This item is not applicable to the Company - Mine Safety Disclosures are not applicable to the Company[155] Item 5. Other Information The Board approved and adopted the Third Amended and Restated Bylaws on August 5, 2025, which amend advance notice provisions for stockholder submissions and clarify that proposals/nominations are for annual meetings only - The Board approved the Third Amended and Restated Bylaws on August 5, 2025, changing advance notice provisions for stockholder proposals and director nominations to between 120 and 90 days before the annual meeting anniversary[155][159] - Stockholder proposals and nominations will only be considered for annual meetings, not special meetings[159] - No directors or officers adopted, amended, or terminated Rule 10b5-1 trading arrangements during the three months ended June 30, 2025[160] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including the Third Amended and Restated Bylaws, stock award plan, certifications, and Inline XBRL documents - Exhibit 3.2: Third Amended and Restated Bylaws of OraSure Technologies, Inc. as of August 5, 2025 - Exhibit 10.1: Amended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan - Exhibit 31.1 & 31.2: Certifications of CEO and CFO required by Rule 13a-14(a) or Rule 15d-14(a) - Exhibit 32.1 & 32.2: Certifications of CEO and CFO required by Rule 13a-14(b) or Rule 15d-14(b) and 18 U.S.C. Section 1350 - Exhibits 101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE: Inline XBRL Taxonomy Extension Documents - Exhibit 104: Cover Page from Interactive Data File SIGNATURES Report Signatures The Quarterly Report on Form 10-Q was duly signed on behalf of OraSure Technologies, Inc. on August 6, 2025, by Kenneth J. McGrath, Chief Financial Officer, and Michele M. Anthony, Senior Vice President, Controller and Chief Accounting Officer - The report was signed on August 6, 2025[166] - Signatories include Kenneth J. McGrath, Chief Financial Officer, and Michele M. Anthony, Senior Vice President, Controller and Chief Accounting Officer[166]