BETHLEHEM, Pa., Jan. 05, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR) (“OraSure” and “OTI”), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that it submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration (FDA) for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) as well as its Colli-Pee™ at-home urine collection device for sexually transmit ...

BETHLEHEM, Pa., Dec. 17, 2025 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (“OraSure” and “OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today confirmed that Altai Capital (“Altai”) has notified the Company of its intent to nominate two candidates, including the fund’s founder, Rishi Bajaj, to stand for election to the Company’s Board of Directors (the “Board”) at its 2026 Annual Meeting of Stockholders. The Company issued the following statemen ...

Summary of OraSure Technologies FY Conference Call Company Overview - **Company**: OraSure Technologies (NasdaqGS: OSUR) - **Event**: FY Conference Call on November 19, 2025 - **Key Speakers**: Ken McGrath (CFO), Jason Plagman (VP of Investor Relations) Industry Insights - **Industry**: Healthcare, specifically in rapid diagnostics and sample management - **Market Size**: The STI market, particularly for chlamydia and gonorrhea, is valued at **$1.5 billion** [22][50] - **International Business**: Revenue in the low to mid **$30 million** range, with a noted slowdown due to funding uncertainties [40][42] Core Points and Arguments 1. **Product Roadmap**: - Excitement around the acquisition of Sherlock, focusing on molecular diagnostics and rapid point-of-care testing [22][23] - Upcoming FDA submissions for the ColiP device for STIs and the Sherlock CT/NG product [23][47] - Anticipated revenue growth from the CT/NG test, projected to be the largest product in 3-5 years [50] 2. **Financial Performance**: - 2025 viewed as a transition year due to uncertainties in government funding [24][26] - Cash position of **$216 million** as of Q3, allowing for flexibility in capital allocation [82][90] - Share buyback program of **$40 million** over two years initiated due to favorable return on invested capital [82][99] 3. **Operational Efficiency**: - Focus on strengthening the core business to achieve break-even cash flow [25][26] - Streamlining operations and diversifying customer base to mitigate risks associated with public health funding [27][32] 4. **Growth Strategy**: - Emphasis on innovation and expanding product offerings in diagnostics and sample management [35][70] - Plans to diversify into blood and other sample types, enhancing capabilities in proteomics and liquid biopsy [34][74] 5. **Market Dynamics**: - Recognition of the value of diagnostics and treatment amidst funding disruptions [40][43] - Positive outcomes from the Together Take Me Home program, which found twice as many positive patients compared to normal channels [43] Additional Important Insights - **Governance**: Strengthened board with new members bringing diverse expertise [28][29] - **COVID-19 Impact**: Lessons learned from the pandemic include enhanced capacity and automation, which are now leveraged for current operations [89][90] - **Future Outlook**: Anticipation of profitable growth driven by new product launches and market expansion in STIs, infectious diseases, and wellness [100] Conclusion OraSure Technologies is positioned for growth with a strong focus on innovation, operational efficiency, and market expansion. The company is navigating through a transition year while maintaining a solid cash position and a strategic roadmap for future product launches.

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Core Insights - OraSure Technologies reported a quarterly loss of $0.13 per share, which was better than the Zacks Consensus Estimate of a loss of $0.16, representing an earnings surprise of +18.75% [1] - The company posted revenues of $27.09 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 7.05% and down from $39.92 million year-over-year [2] - OraSure shares have declined approximately 28.8% year-to-date, contrasting with the S&P 500's gain of 15.1% [3] Financial Performance - Over the last four quarters, OraSure has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.15 on revenues of $31.22 million, and for the current fiscal year, it is -$0.67 on revenues of $121.53 million [7] Market Outlook - The company's stock is currently rated Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] - The Medical - Products industry, to which OraSure belongs, is currently ranked in the bottom 40% of over 250 Zacks industries, which may negatively impact stock performance [8]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $27.1 million, with core revenue at $27.0 million, including diagnostics revenue of $14.5 million and sample management revenue of $10.3 million [4][16] - GAAP gross margin in Q3 was 43.5%, while non-GAAP gross margin was 44.2%, slightly better than expectations due to lower scrap expenses [16][17] - GAAP operating loss in Q3 was $16.1 million, and non-GAAP operating loss was $12.7 million [17] Business Line Data and Key Metrics Changes - International diagnostics revenue is expected to be in the low to mid-$30 million range for the full year 2025, representing a decline of approximately 20% compared to 2024 [6] - U.S. diagnostics business is projected to generate revenue in the low to mid-$30 million range for 2025, indicating a low single-digit percentage decline compared to 2024 [8] - Sample management solution revenue is expected to be in the high $30 million range for the full year, approximately flat compared to 2024, excluding the impact of a decline in orders from a large consumer genetics customer [9][10] Market Data and Key Metrics Changes - The international diagnostics business experienced a slower pace of orders for HIV tests in Q3, as partners worked through existing inventory amid funding environment changes [5] - The U.S. public health customers are facing significant reductions in staffing and budgetary uncertainty, impacting the diagnostics market [7] Company Strategy and Development Direction - The company is focused on strategic transformation to position for growth in 2026, expanding and diversifying its product portfolio and customer relationships [4] - The acquisition of Biomedomics aims to enhance the diagnostic portfolio with SickleScan, targeting underserved markets for sickle cell disease testing [6][18] - The company is investing in internal R&D and partnerships to accelerate profitable growth and leverage existing capabilities [4] Management's Comments on Operating Environment and Future Outlook - Management views 2025 as a transition year, with optimism about pipeline opportunities in attractive markets to drive growth in 2026 and beyond [5] - The company is confident in returning the sample management business to growth in 2026, supported by advancements in genomic sequencing and international market trends [10] Other Important Information - The Together Take Me Home program for HIV self-tests has been renewed, with expected revenue recognition of approximately $1.8 million in Q4 [8] - The company ended Q3 with zero debt and total cash and cash equivalents of $216 million, with negative operating cash flow of $10 million [17] Q&A Session Summary Question: Discussion on Biomedomics acquisition - The acquisition aligns with the company's portfolio for rapid diagnostic testing in underserved markets, leveraging existing strengths in Africa and Latin America [23][24] Question: Insights on gross margins and operating expenses - Gross margins exceeded expectations due to lower scrap expenses, while operating expenses were in line with spending focused on innovation [24][25]

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]