Revenue Performance - Consolidated net revenues decreased 32% to $27.1 million for the three months ended September 30, 2025, compared to $39.9 million for the same period in 2024[98]. - Sales of Diagnostics products decreased 34% to $14.5 million for the three months ended September 30, 2025, primarily due to lower international HIV revenues[99]. - Sample Management Solutions revenues decreased 20% to $10.3 million for the three months ended September 30, 2025, impacted by a large customer's bankruptcy[100]. - COVID-19 Diagnostics revenues decreased 96% to $0.09 million for the three months ended September 30, 2025, due to decreased sales through U.S. government procurement contracts[102]. - Consolidated net revenues decreased 41% to $88.3 million for the nine months ended September 30, 2025, compared to $148.4 million for the same period in 2024[118]. - Sales of Diagnostics products decreased 10% to $51.4 million for the nine months ended September 30, 2025, largely due to lower international HIV revenues[119]. - COVID-19 Diagnostics revenues decreased 99% to $0.6 million for the nine months ended September 30, 2025, reflecting a significant decline in demand[121]. - Non-product and services revenues increased 307% to $4.1 million for the nine months ended September 30, 2025, driven by funded R&D contracts from the Sherlock acquisition[123]. Operating Performance - Consolidated operating loss for the three months ended September 30, 2025, was $16.1 million, compared to a $6.0 million operating loss for the same period in 2024[107]. - Operating loss increased to $51.9 million for the nine months ended September 30, 2025, compared to a loss of $15.8 million in 2024[127]. - Consolidated gross profit margin decreased to 42.2% for the nine months ended September 30, 2025, down from 44.4% in 2024, primarily due to a negative product mix[126]. Expenses - Research and development expenses rose by 56% to $31.1 million for the nine months ended September 30, 2025, driven by clinical trials and operational expenses from acquired companies[128]. - Sales and marketing expenses decreased by 19% to $19.5 million for the nine months ended September 30, 2025, due to reduced employee costs and lower advertising expenses[129]. - General and administrative expenses increased by 14% to $37.9 million for the nine months ended September 30, 2025, largely due to higher legal fees and costs associated with acquisitions[130]. Other Financial Metrics - Other income decreased to $5.7 million for the nine months ended September 30, 2025, down from $9.3 million in 2024, primarily due to lower interest income[133]. - Cash and cash equivalents decreased to $216.5 million at September 30, 2025, from $267.8 million at December 31, 2024[136]. - Working capital decreased to $242.8 million at September 30, 2025, down from $299.7 million at December 31, 2024[137]. - Net cash used in operating activities was $40.0 million for the nine months ended September 30, 2025, influenced by various non-cash charges[138].

Financial Performance - Total net revenues for Q3 2025 decreased 32% to $27.1 million from $39.9 million in Q3 2024[8] - Core revenues, excluding COVID-19, Molecular Services, and Risk Assessment Testing, were $27.0 million, a 25% year-over-year decline[8] - Diagnostics revenues fell 34% year-over-year to $14.5 million, primarily due to lower revenue from HIV tests[8] - Sample Management Solutions revenues decreased 20% year-over-year to $10.3 million, attributed to a large customer in the consumer genomics segment[8] - Net revenues for Q3 2025 were $27.1 million, a decrease of 32.5% compared to $39.9 million in Q3 2024[26] Losses and Expenses - Operating loss for Q3 2025 was $16.1 million, compared to a loss of $6.0 million in Q3 2024[8] - Net loss for the nine months ended September 30, 2025, was $49,445,000, compared to a net loss of $8,706,000 for the same period in 2024, indicating a significant increase in losses[19] - Non-GAAP net loss for the nine months ended September 30, 2025, was $37.2 million, compared to a net income of $8.2 million in the same period of 2024[26] - GAAP operating loss for Q3 2025 was $16.1 million, compared to a loss of $6.0 million in Q3 2024[26] - Non-GAAP operating loss for Q3 2025 was $12.7 million, compared to a loss of $2.7 million in Q3 2024[26] - GAAP net loss per share for Q3 2025 was $0.19, compared to $0.06 in Q3 2024[26] - Non-GAAP loss per share for Q3 2025 was $0.13, compared to a loss of $0.01 in Q3 2024[26] - The company recorded a reduction in workforce severance expense of $1.1 million for the nine months ended September 30, 2025[26] Cash and Assets - Cash and cash equivalents stood at $216 million as of September 30, 2025[8] - Cash and cash equivalents decreased from $267,763,000 to $216,478,000, representing a decrease of about 19.2%[19] - Total assets decreased from $479,659,000 on December 31, 2024, to $423,098,000 on September 30, 2025, a decline of approximately 11.8%[17] - The company reported a net cash decrease of $51,285,000 for the nine months ended September 30, 2025[19] Liabilities and Equity - Total liabilities decreased from $69,321,000 on December 31, 2024, to $61,341,000 on September 30, 2025, a decrease of about 11.5%[17] - Stockholders' equity decreased from $410,338,000 to $361,980,000, reflecting a decline of approximately 11.7%[17] Future Plans and Strategies - The company plans to acquire BioMedomics, adding SickleSCAN, a rapid test for sickle cell disease, to its diagnostic portfolio[7] - The company is guiding for Q4 2025 total revenues of $25 million to $28 million, including less than $100 thousand from COVID-19 testing revenues[10] - The company launched new products expected next year, including the Sherlock over-the-counter molecular self-test for Chlamydia and Gonorrhoeae[4] - The company is focused on expanding international sales and improving operational efficiencies as part of its future growth strategy[22] Capital Expenditures and Compensation - Capital expenditures for the nine months ended September 30, 2025, were $3,275,000, slightly down from $3,341,000 in 2024[18] - Stock-based compensation decreased from $9,178,000 in 2024 to $8,687,000 in 2025, a reduction of approximately 5.4%[18] - Stock compensation expenses for Q3 2025 were $2.8 million, compared to $2.9 million in Q3 2024[26]

Core Insights - OraSure Technologies, Inc. reported a total revenue of $27.1 million for Q3 2025, a decrease of 32% compared to $39.9 million in Q3 2024 [10] - The company anticipates a return to growth in 2026, driven by diversification in its customer base and new product launches [2][3] Financial Performance - Core business revenues decreased by 25% year-over-year to $27.0 million, while COVID-19 related revenues fell by 96% to $89,000 [4][10] - Gross profit for Q3 2025 was $11.8 million, down 31% from $17.1 million in Q3 2024, with a gross margin of 43.5% [5][10] - The operating loss for Q3 2025 was $16.1 million, compared to a loss of $6.0 million in Q3 2024 [5][10] Product and Service Revenue Breakdown - Diagnostics revenues decreased by 34% year-over-year to $14.5 million, primarily due to lower revenue from HIV tests [10] - Sample Management Solutions revenues fell by 20% year-over-year to $10.3 million, attributed to a large customer in the consumer genomics segment [10] - Total net revenues for the nine months ended September 30, 2025, were $88.3 million, down 41% from $148.4 million in the same period of 2024 [4][10] Strategic Developments - The company signed a definitive agreement to acquire BioMedomics, which will enhance its diagnostic portfolio with SickleSCAN, a rapid test for sickle cell disease [11] - OraSure extended its collaboration with the Together Take Me Home program to provide HIV self-tests to at-risk populations [11] - The company appointed Steven K. Boyd to its Board of Directors, bringing valuable experience in public markets and healthcare [11] Financial Guidance - For Q4 2025, the company projects total revenues between $25 million and $28 million, with less than $100,000 expected from COVID-19 testing [8]

Core Insights - OraSure Technologies, Inc. has scheduled its earnings conference call for Q3 2025 financial results on November 5, 2025, at 5 p.m. ET [1] - A webcast of the conference call will be available on OraSure's investor relations page, with access instructions provided [2] Company Overview - OraSure Technologies, Inc. focuses on transforming health through actionable insights and decentralizing diagnostics to enhance healthcare access [3] - The company, along with its subsidiaries DNA Genotek Inc. and Sherlock Biosciences, Inc., is a leader in rapid diagnostic tests and sample collection solutions [3] - OraSure's products are distributed globally to various sectors, including clinical laboratories, hospitals, and direct consumers [3]

Core Insights - OraSure Technologies, Inc. has appointed Steven K. Boyd to its Board of Directors as part of ongoing board refreshment efforts, which have added three new independent directors in the past three years, enhancing operational, financial, and industry expertise [1][2][6] - The company is focused on sustainable, profitable growth through operational excellence, expanding its diagnostics and sample management portfolio, and strengthening its balance sheet [2][4] - Jack Kenny has been appointed as Chair of the Board, succeeding Mara Aspinall, who has stepped down after over eight years of service [4][5] Company Developments - Steven K. Boyd brings over two decades of public markets experience in healthcare and has a strong background in investment, having previously served as Partner at Camber Capital Management [3][4] - The Board now consists of seven directors, six of whom are independent, with a collective expertise in operational, financial, M&A, and life sciences, emphasizing the company's commitment to profitable growth and innovation [5][6] - The company has made significant strides in reshaping its portfolio and strengthening its foundation for future growth, with a focus on delivering value to shareholders [5][6]

Core Viewpoint - Altai Capital Management is preparing to initiate a board fight at OraSure Technologies after increasing its stake in the medical device company, positioning itself as one of the largest shareholders [1] Group 1: Company Actions - Altai Capital Management has raised its holdings in OraSure Technologies, indicating a strategic move to influence the company's governance [1] - The hedge fund's actions suggest a potential push for changes in the board or management structure of OraSure Technologies [1] Group 2: Shareholder Dynamics - Altai Capital Management is now one of the biggest owners of OraSure Technologies, highlighting a shift in shareholder power dynamics within the company [1] - The increased ownership by Altai Capital may lead to heightened scrutiny of OraSure's operational and financial strategies [1]

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) [Filing Details](index=1&type=section&id=Filing%20Details) 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](index=2&type=chunk) | 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](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) [Nature of Forward-Looking Statements](index=3&type=section&id=Nature%20of%20Forward-Looking%20Statements) 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](index=7&type=chunk) - These statements are not guarantees of future performance and involve known and unknown factors that could cause actual results to differ materially[8](index=8&type=chunk) [Risk Factors and Disclaimers](index=3&type=section&id=Risk%20Factors%20and%20Disclaimers) 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](index=9&type=chunk)[11](index=11&type=chunk) - The Company has a policy against disclosing material non-public information to securities analysts or confirming financial forecasts/projections issued by others[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(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](index=9&type=section&id=Consolidated%20Balance%20Sheets) 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](index=17&type=chunk) - Current liabilities increased by **$8.867 million**, largely due to a **$16.981 million** current portion of acquisition-related contingent consideration[17](index=17&type=chunk) [Consolidated Statements of Operations](index=10&type=section&id=Consolidated%20Statements%20of%20Operations) 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) | $(0.06) | - Net revenues decreased by **43%** for the three months and **44%** for the six months ended June 30, 2025, compared to the prior year[19](index=19&type=chunk) - Operating loss significantly widened from **$(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](index=19&type=chunk) [Consolidated Statements of Comprehensive Loss](index=11&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) 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](index=22&type=chunk) [Consolidated Statements of Cash Flows](index=12&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) 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](index=24&type=chunk) - Financing activities used **$6.8 million** in 2025, largely due to **$5.0 million** in common stock repurchases[24](index=24&type=chunk) [Notes to the Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) 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](index=13&type=section&id=1.%20Summary%20of%20Significant%20Accounting%20Policies) 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](index=28&type=chunk) | 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](index=40&type=chunk) [2. Inventories](index=17&type=section&id=2.%20Inventories) 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](index=17&type=section&id=3.%20Property%2C%20Plant%20and%20Equipment%2C%20net) 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](index=50&type=chunk) [4. Accrued Expenses and Other Current Liabilities](index=17&type=section&id=4.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) 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](index=18&type=section&id=5.%20Termination%20Benefits) 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](index=56&type=chunk) [6. Revenues](index=19&type=section&id=6.%20Revenues) 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](index=57&type=chunk) - 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](index=57&type=chunk) [7. Income Taxes](index=21&type=section&id=7.%20Income%20Taxes) 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](index=61&type=chunk) - Uncertain tax positions increased from approximately **$0.0 million** at December 31, 2024, to **$2.5 million** at June 30, 2025[64](index=64&type=chunk) [8. Income (Loss) Per Share](index=21&type=section&id=8.%20Income%20(Loss)%20Per%20Share) 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](index=66&type=chunk) | 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](index=22&type=section&id=9.%20Stockholders%27%20Equity) 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](index=69&type=chunk) - The Company repurchased **1.8 million shares** of common stock under the program during the six months ended June 30, 2025[69](index=69&type=chunk) | (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](index=24&type=section&id=10.%20Business%20Segment%20Information) 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](index=72&type=chunk) | (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](index=26&type=section&id=11.%20Business%20Combinations) 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](index=77&type=chunk)[78](index=78&type=chunk) | 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](index=81&type=chunk) [12. Commitments and Contingencies](index=29&type=section&id=12.%20Commitments%20and%20Contingencies) 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](index=90&type=chunk) - 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](index=91&type=chunk) - A preliminary injunction was entered on **February 27, 2025**, and the trial is scheduled for **March 9, 2026**[91](index=91&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=30&type=section&id=Business%20Overview) 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](index=94&type=chunk) - 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](index=95&type=chunk) [Recent Developments](index=30&type=section&id=Recent%20Developments) 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](index=96&type=chunk) | 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](index=31&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20compared%20to%20June%2030%2C%202024) 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](index=106&type=chunk) - 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](index=107&type=chunk)[108](index=108&type=chunk) [Results of Operations for the Six Months Ended June 30, 2025 compared to June 30, 2024](index=33&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20compared%20to%20June%2030%2C%202024) 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 | $739 | 215% | - Consolidated gross profit margin decreased to **41.6%** from **44.9%**, attributed to a negative product mix (lower InteliSwab® and genomics sales, higher international sales) and partially offset by the termination of the microbiome molecular sequencing services business and improved overhead absorption[127](index=127&type=chunk) - Operating loss widened to **$(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](index=128&type=chunk)[129](index=129&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=139&type=chunk) - 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](index=141&type=chunk) [Critical Accounting Policies and Estimates](index=36&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) 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](index=144&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=145&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=146&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[147](index=147&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=148&type=chunk) - The NowDiagnostics litigation, alleging misappropriation of proprietary information and trade secrets, has a trial scheduled for **March 9, 2026**[149](index=149&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) 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](index=151&type=chunk) - 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](index=151&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=158&type=chunk) | 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](index=154&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities - No defaults upon senior securities were reported[155](index=155&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - Mine Safety Disclosures are not applicable to the Company[155](index=155&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) 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](index=155&type=chunk)[159](index=159&type=chunk) - Stockholder proposals and nominations will only be considered for annual meetings, not special meetings[159](index=159&type=chunk) - No directors or officers adopted, amended, or terminated Rule 10b5-1 trading arrangements during the three months ended June 30, 2025[160](index=160&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) 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](index=40&type=section&id=SIGNATURES) [Report Signatures](index=40&type=section&id=Report%20Signatures) 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](index=166&type=chunk) - Signatories include **Kenneth J. McGrath**, Chief Financial Officer, and **Michele M. Anthony**, Senior Vice President, Controller and Chief Accounting Officer[166](index=166&type=chunk)

Core Insights - OraSure Technologies reported Q2 2025 GAAP revenue of $31.2 million, slightly exceeding Wall Street's estimate of $30.36 million, but reflecting a 43% decline from the previous year [1][2] - Non-GAAP EPS was $(0.19), an improvement over the consensus estimate of $(0.21), but still indicative of ongoing financial pressures as the company transitions from pandemic-driven revenue peaks [1][2] Financial Performance - GAAP revenue decreased by 43% year-over-year from $54.3 million in Q2 2024 [2] - Core business revenue was $30.8 million, down 5% from $32.3 million in Q2 2024 [2] - Gross margin (Non-GAAP) was 43.2%, down from 47.4% in the prior year [2] - Operating loss (Non-GAAP) was $(13.2) million, compared to a profit of $3.3 million a year ago [2][7] Business Overview - OraSure Technologies specializes in rapid diagnostic tests and sample collection devices, including the OraQuick® In-Home HIV test and tools for consumer genomics [3] - The company is focusing on innovation and expanding its diagnostic platform, particularly in molecular diagnostics for sexually transmitted infections [4] Operational Developments - The company experienced a significant decline in overall revenue due to the end of COVID-19-related sales, which fell to near zero [5] - Revenue from the core diagnostics portfolio increased by 3% to $19.2 million, while sample management solutions fell by 22% to $9.9 million [6] Strategic Initiatives - OraSure is investing in new product development and clinical trials, with R&D expenses up 73% compared to the prior year [7] - The company initiated a $40 million share repurchase plan, spending $5 million to buy back 1.8 million shares [8] Cash and Liquidity - At the end of the quarter, the company had $234.6 million in cash and equivalents, but reported negative operating cash flow of $30 million for the first half of 2025 [9] - Management emphasized prudent capital allocation to maintain investment in key growth programs [9] Future Outlook - Management projects GAAP sales in the range of $27 million to $30 million for the upcoming quarters, with no expected revenue bounce from COVID-19 testing [11] - The end of the CDC's Together Take Me Home HIV testing initiative is anticipated to impact future revenue negatively [12]

Company Performance - OraSure Technologies reported a quarterly loss of $0.19 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.15, marking an earnings surprise of -26.67% [1] - The company posted revenues of $31.24 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 2.62%, but down from $54.33 million year-over-year [2] - Over the last four quarters, OraSure has surpassed consensus EPS estimates only once, while it has topped consensus revenue estimates four times [2] Stock Outlook - OraSure shares have declined approximately 13.6% since the beginning of the year, contrasting with the S&P 500's gain of 7.6% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $32.71 million, and for the current fiscal year, it is -$0.53 on revenues of $125.84 million [7] Industry Context - The Medical - Products industry, to which OraSure belongs, is currently ranked in the bottom 38% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact OraSure's stock performance [5]

Financial Data and Key Metrics Changes - Total revenue in Q2 was $31.2 million, with core revenue at $30.8 million, which was above the midpoint of guidance [21] - Core revenue growth would have been positive year over year if excluding the decline from a large consumer genetics customer [21] - GAAP gross margin was 42.1%, and non-GAAP gross margin was 43.2%, better than expectations [22] - GAAP operating loss in Q2 was $18 million, while non-GAAP operating loss was $13.2 million [23] - Operating cash flow in Q2 was negative $10 million, consistent with expectations due to investments in innovation [23] Business Line Data and Key Metrics Changes - Diagnostics revenue was $19.2 million in Q2, growing 3% year over year [21] - Sample Management Solutions revenue was $9.9 million, with growth from other customers excluding the large consumer genetics customer [21] - COVID-19 and risk assessment testing products contributed $474,000 in revenue, consistent with guidance [22] Market Data and Key Metrics Changes - International diagnostics business showed year-over-year revenue growth despite disruptions from USAID funding freezes [8] - US diagnostics revenue declined 1% year over year, with public health customers facing budget cuts and staffing reductions [11] - The "Together Take Me Home" program may continue beyond September 30, with expected revenue of approximately $500,000 in Q3 compared to $2 million in Q2 [12] Company Strategy and Development Direction - The company is focused on three strategic pillars: strengthening the foundation, elevating core growth, and accelerating profitable growth [5] - New product launches, such as HemoCollect protein, aim to meet evolving needs in proteomic research [6][15] - The transition to in-house manufacturing for Sample Management Solutions is expected to improve operational efficiencies starting in 2025 [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in returning to growth in 2026 as customers adapt to the new environment [27] - The company is closely monitoring funding uncertainties in public health programs and research [8][11] - Management highlighted the importance of maintaining strong customer relationships while cultivating new ones [13] Other Important Information - Ann Metzing joined as Chief Commercial Officer to drive sales, marketing, and product management [7] - The company is evaluating inorganic growth opportunities to expand its product portfolio [24] Q&A Session Summary Question: Can you provide specifics on the Q3 guidance regarding HIV and HCV platforms? - Management indicated that Q3 revenue guidance is influenced by the "Together Take Me Home" program and expected slower orders for HIV tests due to inventory management in international markets [33][35] Question: What initial traction has been seen with the HemoCollect protein product? - Management reported enthusiastic customer engagement and highlighted the product's potential in various clinical applications, including oncology and neurology [39][40]