OraSure Technologies(OSUR) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Financial Results Overview OraSure Technologies reported a 43% decline in Q2 2025 net revenues, primarily due to reduced COVID-19 related sales, alongside expanded GAAP and non-GAAP operating and net losses CEO Commentary and Strategic Focus OraSure Technologies' CEO highlighted Q2 performance met expectations, with significant product portfolio expansion and strategic focus on innovation, market reach, and customer diversification for 2026 growth - Q2 performance met expectations, with significant progress in product portfolio expansion, including the July launch of a new blood collection device for proteomics research[2] - The company team is focused on advancing the innovation roadmap, expanding commercial reach, and diversifying customer relationships in new areas[3] - Confident in achieving growth in 2026, with a strong balance sheet providing flexibility for organic and inorganic investments to leverage existing capabilities for profitable long-term growth[3] Key Financial Highlights (Summary) OraSure's Q2 2025 total net revenues decreased 43% year-over-year to $31.2 million, driven by a significant drop in COVID-19 related revenue, with core business revenues down 5% and diagnostic revenues up 3% Summary of Key Financial Data for Q2 2025 (in thousands) | Metric | Q2 2025 | Q2 2024 | % Change | | :-------------------------------- | :------------- | :------------- | :--------- | | Total Net Revenues | $31,200 | $54,300 | (43)% | | Core Business Revenues | $30,800 | $32,300 | (5)% | | Diagnostic Business Revenues | $19,200 | $18,700 | 3% | | Sample Management Solutions Revenues | $9,900 | $12,600 | (22)% | | GAAP Operating Loss | $(18,000) | $(2,700) | NM | | Non-GAAP Operating Loss (Income) | $(13,200) | $3,300 | NM | | GAAP Net Loss | $(19,700) | $(600) | NM | | Non-GAAP Net Loss (Income) | $(14,200) | $5,800 | NM | | Diluted GAAP EPS | $(0.26) | $(0.01) | NM | | Diluted Non-GAAP EPS | $(0.19) | $0.08 | NM | - Cash and cash equivalents totaled $235 million at the end of Q2 2025[7] - The company repurchased 1.8 million shares of common stock for $5 million during Q2[7] Detailed Financial Performance This section provides an in-depth analysis of OraSure's Q2 2025 financial results, detailing consolidated net revenues, gross profit, operating performance, net loss, EPS, and balance sheet and cash flow summaries Consolidated Net Revenues Total net revenues for Q2 2025 were $31.2 million, a 43% decrease from Q2 2024, primarily due to a substantial reduction in COVID-19 related revenues Consolidated Net Revenues (Quarterly and Half-Yearly, in thousands) | Metric | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :----------------- | :------------- | :------------- | :--------- | :----------- | :----------- | :--------- | | Total Net Revenues | $31,242 | $54,335 | (43)% | $61,173 | $108,467 | (44)% | - The 43% decrease in total net revenues was primarily due to reduced COVID-19 revenues[7] Revenue by Business Segment (Q2 and YTD) In Q2 2025, diagnostic revenues increased 3% to $19.2 million, while sample management solutions revenues decreased 22% to $9.9 million, reflecting reduced COVID-19 and risk assessment testing demand Consolidated Net Revenues by Business Segment (in thousands) | Segment | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :-------------------------- | :------------- | :------------- | :--------- | :----------- | :----------- | :--------- | | Diagnostics | $19,222 | $18,746 | 3% | $36,911 | $35,139 | 5% | | Sample Management Solutions | $9,855 | $12,609 | (22)% | $18,965 | $23,431 | (19)% | | Risk Assessment Testing | $446 | $2,308 | (81)% | $1,866 | $4,352 | (57)% | | Other Products and Services | $296 | $542 | (45)% | $617 | $1,092 | (43)% | | COVID-19 Diagnostics | $28 | $18,934 | (100)% | $485 | $42,031 | (99)% | | Molecular Services | $— | $810 | (100)% | $— | $1,683 | (100)% | | Non-Product and Service Revenues | $1,395 | $386 | 261% | $2,329 | $739 | 215% | - Core business revenues (excluding COVID-19, molecular services, and risk assessment testing revenues) in Q2 2025 decreased 5% year-over-year to $30.8 million[7] - The decline in sample management solutions revenues was attributed to a large customer in the consumer genomics sector[7] Gross Profit and Margins Q2 2025 GAAP gross profit declined 47% to $13.2 million, with GAAP gross margin at 42.1%, down from 45.4% in Q2 2024, impacted by lower COVID-19 revenues and higher international sales mix Gross Profit and Margins (Quarterly and Half-Yearly, in thousands) | Metric | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :-------------------- | :------------- | :------------- | :--------- | :----------- | :----------- | :--------- | | GAAP Gross Profit | $13,159 | $24,689 | (47)% | $25,458 | $48,754 | (48)% | | GAAP Gross Margin | 42.1% | 45.4% | -3.3 pp | 41.6% | 44.9% | -3.3 pp | | Non-GAAP Gross Profit | $13,512 | $25,771 | (48)% | $25,980 | $50,218 | (48)% | | Non-GAAP Gross Margin | 43.2% | 47.4% | -4.2 pp | 42.5% | 46.3% | -3.8 pp | - Gross margin was impacted by lower COVID-19 revenues and a higher mix of international revenues, partially offset by operating efficiencies[7] Operating Performance OraSure's Q2 2025 GAAP operating loss significantly widened to $18.0 million from a $2.7 million loss in Q2 2024, with non-GAAP operating loss also expanding to $13.2 million from a $3.3 million gain Operating Loss and Operating Margin (Quarterly and Half-Yearly, in thousands) | Metric | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :---------------------- | :------------- | :------------- | :--------- | :----------- | :----------- | :--------- | | GAAP Operating Loss | $(18,026) | $(2,740) | NM | $(35,776) | $(9,833) | NM | | GAAP Operating Margin | (57.7)% | (5.0)% | -52.7 pp | (58.5)% | (9.1)% | -49.4 pp | | Non-GAAP Operating Loss (Income) | $(13,172) | $3,346 | NM | $(28,452) | $3,022 | NM | | Non-GAAP Operating Margin | (42.2)% | 6.2% | -48.4 pp | (46.5)% | 2.8% | -49.3 pp | - Total operating expenses increased to $31.2 million in Q2 2025 from $27.4 million in Q2 2024[15] - Research and development expenses increased to $11.4 million in Q2 2025 from $6.6 million in Q2 2024[15] Net Loss and Earnings Per Share (EPS) The company's Q2 2025 GAAP net loss surged to $19.7 million (diluted EPS of $(0.26)), compared to a $0.6 million net loss (diluted EPS of $(0.01)) in Q2 2024 Net Loss and Earnings Per Share (Quarterly and Half-Yearly, in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :-------------------- | :------------- | :------------- | :--------- | :----------- | :----------- | :--------- | | GAAP Net Loss | $(19,693) | $(615) | NM | $(35,733) | $(4,199) | NM | | Diluted GAAP EPS | $(0.26) | $(0.01) | NM | $(0.48) | $(0.06) | NM | | Non-GAAP Net Loss (Income) | $(14,193) | $5,774 | NM | $(27,332) | $8,860 | NM | | Diluted Non-GAAP EPS | $(0.19) | $0.08 | NM | $(0.37) | $0.12 | NM | Balance Sheet and Cash Flow Summary As of June 30, 2025, cash and cash equivalents were $234.6 million, down from $267.8 million at December 31, 2024, with a net cash outflow from operating activities of $29.9 million for the six months ended June 30, 2025 Key Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :--------------- | | Cash and Cash Equivalents | $234,578 | $267,763 | | Total Assets | $445,035 | $479,659 | | Total Stockholders' Equity | $380,721 | $410,338 | Key Cash Flow Data (Half-Yearly, in thousands) | Metric | YTD 2025 | YTD 2024 | | :-------------------------------------- | :----------- | :----------- | | Net Cash (Used in) Provided by Operating Activities | $(29,956) | $14,583 | | Net Cash Provided by (Used in) Investing Activities | $(1,566) | $(40,865) | | Net Cash Used in Financing Activities | $(6,751) | $(3,339) | | Net Decrease in Cash and Cash Equivalents | $(33,185) | $(32,168) | | Cash and Cash Equivalents at End of Period | $234,578 | $258,239 | - Repurchased 1.8 million shares of common stock for $5 million during Q2 2025[7][18] Recent Business Developments OraSure recently launched a new proteomics blood collection device and renewed a key partnership, while also appointing a new Chief Commercial Officer to drive growth Product and Partnership Updates OraSure launched HEMAcollect™ PROTEIN in July to advance proteomics research and renewed its agreement with GeneDx, supporting early diagnosis of rare pediatric diseases - HEMAcollect™ PROTEIN product launched in July to meet evolving proteomics research needs, aiming to transform proteomics discovery by extending protein stability and simplifying research workflows[14] - Renewed customer agreement with GeneDx, where OraSure's ORAcollect kits support early diagnosis of rare pediatric diseases through GeneDx's exome and genome analysis[14] Executive Appointments Anne Messing was appointed Chief Commercial Officer, responsible for sales, marketing, and product management to shape OTI's portfolio vision and drive sustainable growth - Anne Messing appointed Chief Commercial Officer, responsible for sales, marketing, and product management, aiming to achieve market leadership and drive sustainable growth[14] Financial Outlook The company provides revenue guidance for Q3 2025, anticipating total revenues between $27 million and $30 million, with minimal COVID-19 testing revenue Q3 2025 Revenue Guidance OraSure projects Q3 2025 total revenues to be between $27 million and $30 million, with COVID-19 testing revenue expected to be less than $100 thousand Q3 2025 Revenue Guidance (in millions) | Metric | Q3 2025 Guidance | | :---------------------- | :----------------- | | Total Revenues | $27M - $30M | | COVID-19 Testing Revenues | < $100K | Unaudited Financial Statements This section presents detailed unaudited financial statements, including income statements, revenue breakdowns, balance sheets, and cash flow statements for Q2 and YTD 2025 Results of Operations (Income Statement) This section provides detailed unaudited income statements for the three and six months ended June 30, 2025 and 2024, covering net revenues, cost of sales, gross profit, operating expenses, operating loss, and net loss Results of Operations (Income Statement, in thousands) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :------------------------------------------------ | :------------- | :------------- | :----------- | :----------- | | Net Revenues | $31,242 | $54,335 | $61,173 | $108,467 | | Cost of Product and Service Revenues | $18,083 | $29,646 | $35,715 | $59,713 | | Gross Profit | $13,159 | $24,689 | $25,458 | $48,754 | | Research and Development Expenses | $11,401 | $6,599 | $21,004 | $14,337 | | Selling and Marketing Expenses | $6,375 | $7,931 | $13,234 | $16,379 | | General and Administrative Expenses | $12,676 | $11,845 | $26,778 | $23,479 | | Total Operating Expenses | $31,185 | $27,429 | $61,234 | $58,587 | | Operating Loss | $(18,026) | $(2,740) | $(35,776) | $(9,833) | | Net Loss | $(19,693) | $(615) | $(35,733) | $(4,199) | Consolidated Net Revenues Breakdown This section details consolidated net revenues by product and service categories for the three and six months ended June 30, 2025 and 2024, highlighting significant declines in COVID-19 and molecular services revenues Consolidated Net Revenues Breakdown by Business Segment (in thousands) | Segment | Q2 2025 | Q2 2024 | % Change | YTD 2025 | YTD 2024 | % Change | | :-------------------------- | :------------- | :------------- | :--------- | :----------- | :----------- | :--------- | | Diagnostics | $19,222 | $18,746 | 3% | $36,911 | $35,139 | 5% | | Sample Management Solutions | $9,855 | $12,609 | (22)% | $18,965 | $23,431 | (19)% | | Risk Assessment Testing | $446 | $2,308 | (81)% | $1,866 | $4,352 | (57)% | | Other Products and Services | $296 | $542 | (45)% | $617 | $1,092 | (43)% | | COVID-19 Diagnostics | $28 | $18,934 | (100)% | $485 | $42,031 | (99)% | | Molecular Services | $— | $810 | (100)% | $— | $1,683 | (100)% | | Net Product and Service Revenues | $29,847 | $53,949 | (45)% | $58,844 | $107,728 | (45)% | | Non-Product and Service Revenues | $1,395 | $386 | 261% | $2,329 | $739 | 215% | | Net Revenues | $31,242 | $54,335 | (43)% | $61,173 | $108,467 | (44)% | Condensed Consolidated Balance Sheets As of June 30, 2025, total assets decreased to $445.0 million from $479.7 million at December 31, 2024, with reductions in cash and cash equivalents, accounts receivable, and inventory Condensed Consolidated Balance Sheets Key Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :--------------- | | Cash and Cash Equivalents | $234,578 | $267,763 | | Accounts Receivable, Net | $25,900 | $23,816 | | Inventory | $33,375 | $34,197 | | Property, Plant and Equipment, Net | $42,155 | $45,105 | | Total Assets | $445,035 | $479,659 | | Accounts Payable | $6,380 | $8,173 | | Deferred Revenue | $2,446 | $2,961 | | Total Stockholders' Equity | $380,721 | $410,338 | | Total Liabilities and Stockholders' Equity | $445,035 | $479,659 | Consolidated Statement of Cash Flows For the six months ended June 30, 2025, OraSure reported a net cash outflow of $29.9 million from operating activities, a significant shift from a $14.6 million inflow in the prior year, including $5.0 million for common stock repurchases Consolidated Statement of Cash Flows Key Data (Half-Yearly, in thousands) | Metric | YTD 2025 | YTD 2024 | | :-------------------------------------- | :----------- | :----------- | | Net Cash (Used in) Provided by Operating Activities | $(29,956) | $14,583 | | Net Cash Provided by (Used in) Investing Activities | $(1,566) | $(40,865) | | Net Cash Used in Financing Activities | $(6,751) | $(3,339) | | Effect of Exchange Rate Changes on Cash | $5,088 | $(2,547) | | Net Decrease in Cash and Cash Equivalents | $(33,185) | $(32,168) | | Cash and Cash Equivalents at End of Period | $234,578 | $258,239 | - Repurchased $5 million of common stock during the six months ended June 30, 2025[18] Non-GAAP Financial Measures This section explains OraSure's use of non-GAAP financial measures, providing reconciliations to GAAP, to offer investors a clearer view of core operating performance by excluding certain non-recurring items Explanation of Non-GAAP Measures OraSure utilizes non-GAAP financial measures to provide investors with supplementary information, enhancing transparency into core operating performance and facilitating period-over-period comparisons by excluding certain non-recurring expenses - Non-GAAP financial measures are intended to provide useful supplemental information to investors and facilitate analysis of the company's core operating performance and period-over-period comparisons of operating results[23] - Management believes these non-GAAP financial measures provide greater transparency by excluding certain expenses that may not be representative of the company's recurring core business operations performance[23] - Management also uses non-GAAP financial measures to develop budgets and manage the company's business[23] GAAP to Non-GAAP Reconciliation This section provides detailed reconciliation tables between GAAP and non-GAAP financial metrics, adjusting for items such as stock-based compensation, acquisition-related intangible asset amortization, and severance costs GAAP to Non-GAAP Reconciliation (Key Adjustments, in thousands) | Adjustment Type | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :------------------------------------------------ | :------------- | :------------- | :----------- | :----------- | | Stock-based compensation (Operating Loss Adjustment) | $3,166 | $3,322 | $5,853 | $6,289 | | Amortization of acquisition-related intangible assets | $58 | $58 | $113 | $117 | | Inventory reserve for discontinued product line | $146 | $— | $146 | $— | | Severance costs for workforce reduction | $— | $1,652 | $— | $2,057 | | Executive severance costs | $751 | $— | $751 | $— | | Impairment loss | $— | $1,054 | $— | $4,392 | | Change in fair value of acquisition-related contingent consideration | $733 | $— | $1,211 | $— | | Loss on equity investment (Net Loss Adjustment) | $802 | $560 | $1,326 | $560 | - Adjustments include non-cash stock-based compensation, amortization of acquisition-related intangible assets, inventory reserves for discontinued product lines, executive and employee severance costs, asset impairment losses, and changes in fair value of contingent consideration[25][26] Additional Information This section provides background on OraSure Technologies, outlines forward-looking statements, and details the conference call for Q2 2025 results About OraSure Technologies OraSure Technologies, Inc. (OTI) is a leader in point-of-care and home diagnostic tests and sample management solutions, developing, manufacturing, and distributing rapid diagnostic tests and sample collection devices globally - OraSure Technologies is a leader in point-of-care and home diagnostic tests and sample management solutions[20] - Company products are sold globally to clinical laboratories, hospitals, physician offices, clinics, public health and community organizations, research institutions, government agencies, pharmaceutical companies, and directly to consumers[20] Forward-Looking Statements This press release contains forward-looking statements regarding future performance, products, and financial results, which are subject to known and unknown risks and uncertainties that could cause actual results to differ materially - This press release contains forward-looking statements regarding products, product candidate development and manufacturing activities, regulatory submissions and authorizations, revenue growth, and guidance[21] - Forward-looking statements are not guarantees of future performance or results, and known and unknown factors could cause actual results or outcomes to differ materially from those expressed or implied in these statements[21] - Readers are cautioned not to place undue reliance on forward-looking statements, and the company undertakes no obligation to update these statements[22] Conference Call Details OraSure held a conference call and audio webcast on August 5, 2025, at 5:00 PM ET, to discuss Q2 2025 results and business developments, with details provided for webcast access and pre-registration - The company held a conference call and audio webcast on August 5, 2025, at 5:00 PM ET, to discuss Q2 2025 results and certain business developments[10] - The webcast is available on the investor relations page of OTI's website and will be archived for approximately one year following the call[11] - Participants interested in asking questions during the conference call are required to pre-register via the provided link[12]