OSUR

BETHLEHEM, Pa., May 06, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended March 31, 2026. “Our Q1 results were consistent with our expectations, and revenue of $27.9 million was above the midpoint of our guidance range,” said Carrie Eglinton Manner, President and CEO of OTI. “We delivered gross margin expansion in Q1 and remain focused on leveraging our manufacturing capabilities and capacity to drive additional operating efficiencies.” She continued, “OraSure is well positioned to accelerate our growth as we approach a series of regulatory and commercial milestones in 2026 and continue to transform our business through our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. Additionally, our strong balance sheet gives us the flexibility to pursue acquisitions and partnerships that strengthen our portfolio, while continuing to invest in R&D aimed at high‑value growth markets in order to drive long‑term value for shareholders.” Financial Highlights ($ in 000’s, except per share amounts) (1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues. NM – not meaningful Total net revenues for the first quarter of 2026 decreased 7% to $27.9 million from $29.9 million in the first quarter of 2025. Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $27.9 million in the first quarter decreased 0.5% year-over-year. Diagnostics revenues in the first quarter decreased 5% year-over-year to $16.9 million, with the decline attributable to lower revenue from our HCV tests. Sample Management Solutions revenues of $9.1 million in the first quarter decreased 0.6% year-over-year. GAAP gross margin was 42.3% in the first quarter of 2026 compared to 41.1% in the first quarter of 2025. Non-GAAP gross margin in the first quarter of 2026 was 43.4% and increased compared to 41.7% in the first quarter of 20251. GAAP operating loss in the first quarter of 2026 was $23.3 million compared to GAAP operating loss of $17.8 million in the first quarter of 2025. Non-GAAP operating loss was $19.0 million in the first quarter of 2...

Image source: The Motley Fool. May 6, 2026, 5 p.m. ET President and Chief Executive Officer — Carrie Eglinton Manner Chief Financial Officer — Kenneth J. McGrath Carrie Eglinton Manner, our President and Chief Executive Officer, and Kenneth J. McGrath, our Chief Financial Officer. As a reminder, today's webcast is being recorded; the recording can be found on our Investor Relations website. Before we begin, you should know that this call may contain certain forward-looking statements including statements with respect to revenues, expenses, profitability, earnings or loss per share, and other financial performance, product development, performance, shipments and markets, business plans, regulatory filings and approvals, expectations and strategies. Actual results could be significantly different. Factors that could affect results are discussed more fully in OraSure Technologies, Inc.’s SEC filings, its annual report on Form 10-K for the year ended 12/31/2025, its quarterly reports on Form 10-Q, and its other SEC filings. Although forward-looking statements help to provide more complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today. OraSure Technologies, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I am pleased to turn the call over to Carrie. Carrie Eglinton Manner: Thanks, Jason, and thank you to everyone for joining us today. Today, I will discuss some highlights from Q1 and provide updates on our key priorities for 2026. Overall, we continue to advance our strategic transformation and execute with discipline as we focus on driving growth in 2026 and beyond. We have delivered meaningful progress over the last few years and continue strengthening our foundation, including leveraging our manufacturing capabilities and capacity to drive gross margin expansion while also streamlining our cost structure. We are elevating our core growth by expanding and diversifying our product portfolio and customer relationships, while several of our key end markets adapt to an evolving funding environment. Ultimately, we are accelerating profitable growth through investments in R&D targeting high-value growth markets, as well as acquisitions and partnerships that leverag...

BETHLEHEM, Pa. (AP) — BETHLEHEM, Pa. (AP) — OraSure Technologies Inc. (OSUR) on Wednesday reported a loss of $22.4 million in its first quarter. On a per-share basis, the Bethlehem, Pennsylvania-based company said it had a loss of 32 cents. Losses, adjusted for stock option expense and non-recurring costs, were 24 cents per share. The diagnostic test maker posted revenue of $27.9 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OSUR at https://www.zacks.com/ap/OSUR

OraSure reported Q1 revenue of $27.9 million (up 4% sequentially) with diagnostics up 12%, and improved gross margins to 42.3% GAAP (43.4% non‑GAAP) driven by insourcing manufacturing; management expects Q2 margins to be similar to Q1. The company is awaiting FDA review of two planned mid‑year launches — an OTC rapid molecular CT/NG self‑test (Sherlock platform) and the Colli‑Pee at‑home urine collection device — and anticipates both products will begin contributing revenue in the second half of 2026, though early ramping may pressure margins before becoming accretive. OraSure posted a Q1 GAAP operating loss of $23.3 million but finished the quarter with $177 million in cash and zero debt, repurchased $5 million of stock in Q1 (about $20 million over the past year), expects to return to break‑even operating cash flow entering 2027, and guided Q2 revenue of $27–30 million. Interested in OraSure Technologies, Inc.? Here are five stocks we like better. OraSure Technologies (NASDAQ:OSUR) reported first-quarter 2026 revenue of $27.9 million, topping the midpoint of its prior guidance range, as the company pointed to improving gross margins, ongoing cost actions, and preparations for two planned mid-year product launches that management expects to begin contributing revenue in the second half of the year. Chief Financial Officer Ken McGrath said total revenue was $27.9 million in the first quarter, up 4% sequentially. Diagnostic products generated $16.9 million, with a “fairly even split between U.S. and international revenue,” and diagnostics revenue rose 12% sequentially. Sample management solutions revenue was $9.1 million, which McGrath described as “basically flat on a sequential basis.” → Tyson Foods' Total Returns: Tasty Treats for Income Investors? President and Chief Executive Officer Carrie Eglinton Manner said the company continues to “advance our strategic transformation and execute with discipline,” including efforts to leverage manufacturing capacity to expand gross margins while streamlining costs. She also said OraSure is “elevating our core growth by expanding and diversifying our product portfolio and customer relationships” as several end markets adapt to a changing funding environment. In international diagnostics, Manner highlighted progress with “distribution partners in Africa” tied to “in-country value-added assembly and manufacturing, also...

Management is driving gross margin expansion by in-sourcing production from third-party manufacturers to internal Pennsylvania facilities, leveraging capacity built during the pandemic. International growth is being revitalized through 'near-shoring' initiatives, establishing closer relationships with African distribution partners for in-country assembly and manufacturing. The U.S. Diagnostics segment is seeing stabilized demand from public health customers as they adapt to current budget environments, with HIV testing remaining a prioritized core service. Sample Management performance reflects a divergence between growing commercial precision medicine utilization and muted academic demand due to slow NIH research grant funding. The company is shifting toward a 'syndemic approach' in diagnostics, bundling rapid tests for HIV, HCV, and syphilis to provide higher value and ease of use for customers. Strategic transformation efforts are focused on decentralizing diagnostics by making testing more accessible, private, and affordable through self-test and at-home collection innovations. Management anticipates mid-year FDA clearances for two key products: a rapid molecular self-test for CT/NG and the Colli-Pee at-home urine collection device. Revenue from new product launches is expected to ramp in the second half of the year, though initial margins may be lower during the early volume-absorption phase. Operating expenses are projected to decline from the high $20 million range in Q2 to the mid-$20 million range in Q3 as non-run rate launch preparation costs wind down. The company maintains a target to return to breakeven operating cash flow by 2027, supported by new product contributions and continued cost-saving efficiencies. The company's growth strategy focuses on investing in R&D to target high-value growth markets, alongside pursuing acquisitions and partnerships that offer attractive risk-adjusted returns. Q1 G&A expenses were elevated by non-recurring items including severance from a February reduction in force and professional services related to a proxy. The company deployed $5 million to repurchase 1.8 million shares in Q1, totaling 7.1 million shares repurchased over the last four quarters. Q2 revenue guidance of $27 million to $30 million assumes a negligible contribution from COVID-19 testing as the business pivots to core diagnostics. Management not...

BETHLEHEM, Pa., April 22, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR) has scheduled its regular earnings conference call covering first quarter 2026 financial results and certain business developments for 5 p.m. ET on May 6, 2026. A webcast of the conference call will be available on the investor relations page of OraSure’s website at https://orasure.gcs-web.com/events-and-presentations. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes prior to the call. The webcast will be archived on OraSure’s website shortly after the call has ended. About OraSure Technologies, Inc. OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information, please visit www.orasure.com

BETHLEHEM, Pa., Feb. 25, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended December 31, 2025. “Our Q4 results were consistent with our expectations, and revenue of $26.8 million was above the midpoint of our guidance range,” said Carrie Eglinton Manner, President and CEO of OTI. “We supported our customers in navigating a challenging funding environment in 2025, and we are encouraged to see increasing signs of stability in key segments as we enter 2026.” She continued, “We are confident that OTI is positioned to return to growth in 2026, supported by anticipated U.S. regulatory clearance and launches of our rapid molecular self-test for Chlamydia and Gonorrhoeae and our Colli-Pee™ at-home urine collection device for sexually transmitted infections. We are making meaningful progress on our innovation roadmap and executing on our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. Additionally, our strong balance sheet allows us to make disciplined investments in value-enhancing organic and inorganic opportunities while prudently returning capital to shareholders through our $40 million share repurchase program which we continue to execute.” Financial Highlights ($ in 000’s, except per share amounts) (1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues. NM – not meaningful Total net revenues for the fourth quarter of 2025 decreased 29% to $26.8 million from $37.4 million in the fourth quarter of 2024. Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $26.7 million in the fourth quarter decreased 22% year-over-year. Diagnostics revenues in the fourth quarter decreased 20% year-over-year to $15.1 million, with the decline attributable to lower revenue from our HIV tests. Sample Management Solutions revenues in the fourth quarter decreased 39% year-over-year to $9.1 million, with the majority of the decline attributable to a large customer in the consumer genomics segment. GAAP gross margin was 41.0% in the fourth quarter of 2025 compared to 36.2% in the fourth quarter of 2024. Non-GAAP gros...

Management characterized 2025 as a transition year focused on supporting customers through a challenging and uncertain funding environment. International Diagnostics stabilization is being driven by new framework agreements between the U.S. and over a dozen African nations to build resilient health systems. The company is pivoting to a 'nearshoring' strategy in Africa, establishing local value-added assembly and manufacturing to align with national self-sufficiency trends. U.S. Diagnostics demand is stabilizing as public health organizations adapt to federal and state funding shifts, with consistent growth in telehealth and direct-to-consumer platforms. Sample Management growth is attributed to the clinical adoption of precision medicine and a return to regular NIH funding cadences. Operational efficiency was improved by consolidating manufacturing from Thailand and Canada into the Bethlehem, Pennsylvania facility to leverage overhead absorption. The acquisition of BiMedomics allows OTI to leverage existing international sales channels to address the high incidence of sickle cell disease in Africa and Latin America. Management anticipates a revenue ramp in the second half of 2026 driven by the midyear launches of the CT/NG rapid molecular self-test and Colli-Pee collection device. The company expects to return to operating cash flow breakeven by 2027, contingent on revenue growth from new products and continued cost-saving efficiencies. Q1 2026 guidance assumes a slight sequential improvement in gross margin to the low 40% range due to better manufacturing absorption. R&D expenses are expected to taper off throughout 2026 following the completion of major clinical trials, though some data collection continues in Q1. Strategic expansion into clinical settings like urgent care and emergency rooms is expected to offset historical reliance on public health funding. Management eliminated several non-production roles recently to align the cost structure with current revenue levels. The regulatory review process for the two December FDA submissions remains a source of timing uncertainty for the second-half ramp. The company deployed $15 million for share repurchases in 2025, maintaining a balanced capital strategy alongside M&A. Nearshoring revenue contributions are expected to begin in Q1 2026 and scale throughout the year. Our analysts just identified a stock wit...

BETHLEHEM, Pa. (AP) — BETHLEHEM, Pa. (AP) — OraSure Technologies Inc. (OSUR) on Wednesday reported a loss of $19.3 million in its fourth quarter. On a per-share basis, the Bethlehem, Pennsylvania-based company said it had a loss of 27 cents. Losses, adjusted for non-recurring costs and stock option expense, were 19 cents per share. The diagnostic test maker posted revenue of $26.8 million in the period. For the year, the company reported a loss of $68.7 million, or 94 cents per share. Revenue was reported as $115 million. For the current quarter ending in March, OraSure said it expects revenue in the range of $26 million to $29 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OSUR at https://www.zacks.com/ap/OSUR

OraSure reported Q4 revenue of $26.8 million (core ex‑COVID $26.7 million, above the midpoint of guidance) with GAAP gross margin up to 41% but a GAAP operating loss of $20.1 million; the company finished 2025 with $199 million in cash and zero debt and returned $15 million to shareholders via buybacks. Management submitted two FDA applications in December and is targeting mid‑2026 launches for a 30‑minute OTC CT/NG molecular self‑test (Sherlock platform) and the Colli‑Pee at‑home urine collection device, which it says could drive a H2‑2026 revenue ramp despite regulatory timing uncertainty. International diagnostics order trends are stabilizing as funding visibility improves, with a push toward nearshoring assembly/manufacturing in Africa expected to contribute revenue in 2026, plus expansion via the BioMedomics acquisition (Sickle SCAN) and a Health Canada license for OraQuick. Interested in OraSure Technologies, Inc.? Here are five stocks we like better. OraSure Technologies (NASDAQ:OSUR) reported fourth-quarter 2025 revenue of $26.8 million, with management pointing to early signs of stabilization across key end markets after what it described as a transition year marked by a challenging funding environment. On the company’s earnings call, executives also highlighted two mid-year product launches as near-term growth catalysts, following FDA submissions made in December. Chief Financial Officer Ken McGrath said core revenue—excluding COVID-19 products—was $26.7 million, which management noted was above the midpoint of the company’s guidance range. Diagnostic products generated $15.1 million in fourth-quarter revenue, while sample management solutions contributed $9.1 million, both described as consistent with expectations. → Microsoft Is Sliding—An Insider Buy and Oversold Signals Are Changing the Setup OraSure posted a GAAP gross margin of 41% in the quarter, up from 36.2% in the year-ago period. Non-GAAP gross margin was 41.4%, compared to 40.1% a year earlier. Operating expenses included R&D expense of $11.4 million, sales and marketing expense of $6.6 million, and general administrative expense of $9.8 million. The company reported a GAAP operating loss of $20.1 million and a non-GAAP operating loss of $15.2 million. President and CEO Carrie Eglinton Manner said 2025 was a transition year in which OraSure supported customers “in navigating a challengi...

This article first appeared on GuruFocus. Total Revenue: $26.8 million in Q4 2025. Core Revenue: $26.7 million, excluding COVID-19 products. Diagnostic Products Revenue: $15.1 million in Q4. Sample Management Solutions Revenue: $9.1 million in Q4. GAAP Gross Margin: 41% in Q4, up from 36.2% in Q4 2024. Non-GAAP Gross Margin: 41.4% in Q4, up from 40.1% in Q4 2024. GAAP Operating Loss: $20.1 million in Q4. Non-GAAP Operating Loss: $15.2 million in Q4. Cash and Cash Equivalents: $199 million at year-end. Share Repurchase: $5 million spent to repurchase 1.9 million shares in Q4. Operating Cash Flow: Negative $9 million in Q4. Q1 2026 Revenue Guidance: $26 million to $29 million. Q1 2026 Gross Margin Guidance: Expected in the low 40% range. Warning! GuruFocus has detected 4 Warning Signs with OSUR. Is OSUR fairly valued? Test your thesis with our free DCF calculator. Release Date: February 25, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OraSure Technologies Inc (NASDAQ:OSUR) reported total revenue of $26.8 million for Q4 2025, exceeding the midpoint of their guidance range. The company is launching two new products in mid-2026: a rapid molecular self-test for chlamydia and gonorrhea (CT/NG) and the Colli-Pee at-home urine collection device for sexually transmitted infections. OraSure Technologies Inc (NASDAQ:OSUR) expanded its presence in Canada with the launch of the OraQuick HIV Self-Test, the first oral HIV self-test licensed by Health Canada. The integration of BioMedomics is progressing well, with strong demand for the Sickle SCAN test, particularly in Africa and Latin America. The company ended the year with zero debt and $199 million in cash and cash equivalents, reflecting a strong balance sheet. OraSure Technologies Inc (NASDAQ:OSUR) reported a GAAP operating loss of $20.1 million and a non-GAAP operating loss of $15.2 million for Q4 2025. Operating cash flow was negative $9 million in the fourth quarter, attributed to investments in the Sherlock platform and clinical trials. The company anticipates lower R&D expenses in 2026, but ongoing clinical trials will continue to incur costs. There is uncertainty in the regulatory review process for the new product launches, which could impact the timing of revenue ramp-up. The company is operating at approximately 30% capacity, indicating underutiliza...