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]

Investment Highlights - OraSure Technologies (OTI) is positioned to return to growth in its core business in 2025[5] - OTI has a differentiated product pipeline aligned with long-term healthcare trends, with potential product milestones expected to accelerate growth in 2025 and beyond[5] - OTI has an opportunity for significant operating margin leverage as volumes grow[5] - As of Q3 2024, OTI has $279 million of cash and no debt[5, 37] Strategic Transformation - OTI is focused on strengthening its foundation, elevating core growth, and accelerating profitable growth[7, 42] - OTI aims to improve access, quality, and value of healthcare with innovation in effortless tests and sample management solutions[9] - OTI is expanding its diagnostics portfolio with new tests and next-generation platform expansion, prioritizing instrument-free tests[12, 13] - OTI's acquisition of Sherlock Biosciences strengthens and broadens its diagnostic portfolio with molecular testing capabilities[19] - OTI anticipates submitting Sherlock's disposable self-test for CT/NG to the FDA by the end of 2025, targeting a $1.5 billion and growing market[22] Financial Performance - OTI is targeting a path to 50% adjusted gross margin[40] - The company's non-GAAP gross margin was 40% in FY23 and an estimated 40% in FY24[38] - Core revenue was $143 million in FY23 and an estimated $138 million in FY24, while COVID-19 revenue was $115 million in FY23 and an estimated $45 million in FY24[38]