Core Insights - OraSure Technologies is focused on executing a transformation strategy aimed at enhancing operational performance and driving long-term value creation, with significant regulatory and commercial milestones expected in 2026 [1][2] Group 1: Company Strategy and Performance - The company anticipates a return to revenue growth in 2026, driven by stabilization in core end-markets and the clinical adoption of precision medicine, alongside the launch of high-impact products targeting a combined $2 billion addressable market [2] - OraSure has submitted two product applications to the U.S. FDA for its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae, and the Colli-Pee at-home urine collection device, positioning the company for regulatory decisions and commercialization in 2026 [2] - Operational changes since late 2022 have included a 40% reduction in workforce and the closure of four global sites, leading to a 37% reduction in annual SG&A expenses and approximately 260 basis points of adjusted gross margin expansion [2] Group 2: Capital Allocation and Shareholder Engagement - The company has initiated a $40 million share repurchase program, reflecting confidence in its earnings potential and improving free cash flow [2] - OraSure's Board has engaged with Altai Capital for over a year, attempting to reach a constructive resolution regarding Altai's demands, while consistently remaining open to ideas from Altai [5][6] - The Board has proposed to appoint Altai's nominee, Mr. Bertrand, as an independent director, while also committing to declassify the Board beginning in 2027 [7][8] Group 3: Board Composition and Governance - OraSure's Board has been refreshed over the past six years, adding three new independent directors with relevant industry expertise, enhancing oversight as the company positions itself for growth [4] - The leadership team has demonstrated confidence in the company's strategy through personal investments in OraSure stock, continuing into 2026 [3]

Core Viewpoint - Altai Capital Management has issued a letter to the OraSure Board, advocating for significant changes due to the company's chronic underperformance and proposing the appointment of their nominees to the Board [1][2]. Group 1: Underperformance Issues - OraSure's share price has significantly underperformed compared to similar companies and broader indices over the past five and ten years, primarily due to operational and strategic failures under current management [2]. - The company continues to incur cash losses while pursuing speculative diagnostics investments, negatively impacting shareholder value [2]. Group 2: Board Composition and Compensation - Independent directors own less than 1% of the company's shares but receive over $250,000 annually in compensation, indicating a lack of financial risk associated with their decisions [2]. - Over 90% of CEO Carrie Eglinton Manner's compensation is not linked to share price performance, with her earning approximately $15 million while shareholders have lost 60% of their investment since 2023 [2]. Group 3: Strategic Recommendations - A strategic review is necessary, including the potential sale of the entire business, to ensure the best returns for shareholders [2]. - Altai's nominees, Rishi Bajaj and John Bertrand, have proven track records in transforming companies and will align their compensation with shareholder returns [2].

"OraSure is worth significantly more in a sale than as a standalone company," Altai's President and Chief Investment Officer Rishi Bajaj wrote to OraSure's board on Tuesday. "After deducting transaction costs, we estimate OraSure is worth $4.54 to $6.60 per share if sold — a 42% to 109% premium to today's price," Bajaj wrote. OraSure has seen its stock price tumble 73% over the last five years as demand for COVID-19 rapid antigen tests has fallen. Exclusive: Altai Capital presses OraSure to sell and give it ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________________ or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to Commission File No. 001-16537 __________________________________________________________ ORASURE TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) | ____________________________________________________ ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $26.8 million, with core revenue at $26.7 million, exceeding the midpoint of guidance [5][12] - GAAP gross margin improved to 41% from 36.2% in Q4 2024, while non-GAAP gross margin rose to 41.4% from 40.1% [13] - GAAP operating loss for Q4 was $20.1 million, and non-GAAP operating loss was $15.2 million [14] Business Line Data and Key Metrics Changes - Diagnostic products generated $15.1 million in revenue for Q4, while sample management solutions contributed $9.1 million, both aligning with expectations [12] - Demand for the Sickle SCAN test is strong, particularly in Africa and Latin America, where there is a high incidence of sickle cell disease [7] Market Data and Key Metrics Changes - Order trends in the international diagnostics business are stabilizing, with new funding structures in place in over 12 African countries [5][6] - The company is expanding its presence in Canada with the launch of the OraQuick HIV self-test, the first oral HIV self-test in the country [6] Company Strategy and Development Direction - The company is focused on a multiyear strategic transformation aimed at delivering profitable growth and creating value for customers and shareholders [4] - Nearshoring opportunities are being pursued to establish local manufacturing and assembly in African countries, which is expected to contribute to revenue growth [6][24] Management's Comments on Operating Environment and Future Outlook - Management noted signs of market stabilization and expressed optimism about growth opportunities from upcoming product launches [4][17] - The company anticipates a return to breakeven in operating cash flow by 2027, driven by expected revenue growth and cost-saving measures [15] Other Important Information - The company ended the year with no debt and total cash and cash equivalents of $199 million [14] - A total of $15 million was returned to shareholders through stock repurchases in 2025 [14] Q&A Session Summary Question: R&D expenses outlook - Management anticipates lower R&D expenses throughout 2026, with some continuation of clinical trials for new product launches [19][20] Question: International HIV ordering cadence - Management indicated improved visibility and stabilization in funding and implementation in African countries [21][22][23] Question: Product launch visibility and revenue ramp - Management is working towards mid-year launches but noted uncertainty in the regulatory review process [29][30] Question: Sample management growth outlook - Excluding a large customer headwind, sample management saw year-over-year growth, driven by diversification of the customer base [36][37] Question: Gross margin trends - Management expects sequential improvement in gross margins as revenue ramps up, benefiting from operational efficiencies [38][39][40] Question: Growth normalization vs. end market growth - Management believes core business growth will stabilize, with product launches expected to accelerate growth in 2026 [43][44][45]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $26.8 million, with core revenue at $26.7 million, exceeding the midpoint of guidance [5][12] - GAAP gross margin improved to 41% from 36.2% in Q4 2024, while non-GAAP gross margin rose to 41.4% from 40.1% in Q4 2024 [13] - Operating loss for Q4 was $20.1 million on a GAAP basis and $15.2 million on a non-GAAP basis [14] Business Line Data and Key Metrics Changes - Diagnostic products generated $15.1 million in revenue for Q4, while sample management solutions contributed $9.1 million [12] - Demand for the Sickle SCAN test is strong, particularly in Africa and Latin America, where Sickle Cell Disease is prevalent [7] - The sample management business is expected to grow as genomic segments stabilize and return to stronger growth [8] Market Data and Key Metrics Changes - International diagnostics business is stabilizing, with order trends improving due to revised funding structures in Africa [5][6] - The company is establishing closer relationships with distribution partners in Africa, which is expected to contribute to revenue in Q1 and throughout 2026 [6] - The integration of BioMedomics is progressing well, enhancing the company's portfolio of rapid diagnostic tests [6] Company Strategy and Development Direction - The company is focused on a multiyear strategic transformation aimed at delivering profitable growth and creating value for customers and shareholders [4] - Two product launches are planned for mid-2026: a rapid molecular self-test for Chlamydia and Gonorrhea and the Colli-Pee at-home urine collection device [4][10] - The strategy includes nearshoring opportunities to enhance local manufacturing and assembly in Africa [6][24] Management's Comments on Operating Environment and Future Outlook - Management noted signs of market stabilization and improved visibility to funding for testing and research programs as they enter 2026 [4] - The company anticipates returning to breakeven in operating cash flow by 2027, driven by expected revenue growth from product launches [15] - Management emphasized the importance of adapting to the current funding environment and the critical nature of testing in life-saving programs [45] Other Important Information - The company ended the year with zero debt and total cash and cash equivalents of $199 million [14] - A total of $15 million was returned to shareholders through stock repurchases in 2025 [14] Q&A Session Summary Question: R&D expenses outlook post product submissions - Management anticipates lower R&D expenses throughout the year, with some continuation of clinical trials to support product launches [19][20] Question: Normalization of international HIV orders - Management indicated improved visibility in Africa regarding funding and implementation, with signs of recovery in ordering cadence [21][22][23] Question: FDA visibility for product launches - Management is working towards mid-year launches but noted uncertainty in the regulatory review process [29][30] Question: Growth outlook for sample management - Excluding a large customer headwind, management noted year-over-year growth in sample management, driven by diversification of the customer base [36][37] Question: Gross margin trends - Management expects sequential improvement in gross margins as revenue ramps up, benefiting from operational efficiencies [38][39][40] Question: Growth expectations for 2026 - Management believes core business growth will stabilize, with product launches expected to accelerate growth in the second half of the year [43][44][45]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $26.8 million, with core revenue at $26.7 million, exceeding the midpoint of guidance [6][13] - Diagnostic products generated $15.1 million in revenue, while sample management solutions contributed $9.1 million [13] - GAAP gross margin improved to 41% from 36.2% in Q4 2024, and non-GAAP gross margin increased to 41.4% from 40.1% [13] - GAAP operating loss for Q4 was $20.1 million, with a non-GAAP operating loss of $15.2 million [13][14] - The company ended the year with no debt and total cash and cash equivalents of $199 million [14] Business Line Data and Key Metrics Changes - The international diagnostics business is stabilizing, with improved order trends as national health programs adapt to new funding structures [6][7] - Demand for the Sickle SCAN test is strong, particularly in Africa and Latin America, where there is a high incidence of sickle cell disease [8] - The sample management business is expected to grow as genomic segments stabilize and return to stronger growth [9] Market Data and Key Metrics Changes - The company is establishing closer relationships with distribution partners in Africa, which is expected to contribute to revenue in Q1 2026 [7] - The integration of BioMedomics is progressing well, with strong demand for rapid diagnostic tests [7] Company Strategy and Development Direction - The company is focused on a multiyear strategic transformation aimed at delivering profitable growth and creating value for customers and shareholders [6] - Two product launches are planned for mid-2026: a rapid molecular self-test for chlamydia and gonorrhea, and the Colli-Pee at-home urine collection device for STIs [6][10] - The company is pursuing nearshoring opportunities to enhance local manufacturing and assembly in Africa [7][25] Management's Comments on Operating Environment and Future Outlook - Management noted signs of market stabilization and expressed optimism about growth opportunities from upcoming product launches [5][18] - The company anticipates returning to breakeven in operating cash flow by 2027, driven by expected revenue growth and cost savings [16] - Management highlighted the importance of adapting to funding changes in public health and the critical nature of testing in life-saving programs [45] Other Important Information - The company repurchased $5 million worth of shares in Q4 and returned $15 million to shareholders through share repurchases in 2025 [14][15] - Operating cash flow in Q4 was negative $9 million, consistent with expectations due to investments in innovation [16] Q&A Session Summary Question: Anticipation of R&D expenses tapering off - Management expects lower R&D expenses throughout the year, with some continuation of clinical trials [20][21] Question: Normalization of ordering cadence in international HIV - Management noted improved visibility and stabilization in funding and implementation in African countries [23][24] Question: Updates on product launches and FDA visibility - Management is working towards mid-year launches but noted uncertainty in the regulatory review process [30] Question: Expansion into clinical settings - Management is encouraged by progress in expanding customer segments beyond public health to clinical settings [31][33] Question: Growth outlook for sample management - Management indicated growth in sample management, driven by diversification of the customer base [38] Question: Gross margin expectations - Management expects sequential improvement in gross margins as revenue ramps up [40] Question: Recovery versus end market growth in 2026 - Management believes core business growth will stabilize, with product launches expected to accelerate growth [44][46]

Financial Performance - Total net revenues for Q4 2025 decreased 29% to $26.8 million from $37.4 million in Q4 2024[7] - Core revenues, excluding COVID-19, Molecular Services, and Risk Assessment Testing, were $26.7 million in Q4 2025, a 22% decrease year-over-year[7] - Diagnostics revenues in Q4 2025 decreased 20% year-over-year to $15.1 million, primarily due to lower revenue from HIV tests[7] - Net revenues for Q4 2025 were $26.763 million, a decrease of 28.6% from $37.445 million in Q4 2024[24] - GAAP operating loss for the year 2025 was $71.969 million, compared to a loss of $28.250 million in 2024[24] - Non-GAAP net loss for the year 2025 was $50.813 million, a significant decline from a net income of $3.943 million in 2024[24] - GAAP net loss per share for Q4 2025 was $0.27, compared to $0.14 in Q4 2024[24] - Non-GAAP loss per share for the year 2025 was $0.69, down from earnings of $0.05 in 2024[24] Cash and Assets - Cash and cash equivalents were $199 million as of December 31, 2025[7] - Total assets decreased from $479,659,000 in 2024 to $403,168,000 in 2025, a decline of approximately 15.9%[15] - Cash and cash equivalents dropped from $267,763,000 in 2024 to $199,278,000 in 2025, representing a decrease of about 25.5%[17] - The company reported a net cash decrease of $68,485,000 in 2025, compared to a decrease of $22,644,000 in 2024[17] Operating Activities - Operating loss for Q4 2025 was $20.1 million, compared to a loss of $12.4 million in Q4 2024[7] - Cash used in operating activities was $(49,023,000) in 2025, a stark contrast to cash provided by operating activities of $27,374,000 in 2024[16] Shareholder Equity and Compensation - The company's stockholders' equity fell from $410,338,000 in 2024 to $340,827,000 in 2025, a decline of approximately 17%[15] - Stock-based compensation decreased from $11,920,000 in 2024 to $10,147,000 in 2025, a reduction of about 14.9%[16] - The company recorded a stock compensation expense of $1.459 million in Q4 2025, down from $2.741 million in Q4 2024[24] Strategic Initiatives - The company is guiding for Q1 2026 total revenues of $26 million to $29 million, with negligible COVID-19 testing revenues included[9] - An application was submitted to the FDA in December 2025 for clearance of a rapid molecular self-test for Chlamydia and Gonorrhoeae[6] - The company plans to continue executing a $40 million share repurchase program[3] - The Colli-Pee™ at-home urine collection device for STIs is expected to expand access to testing upon FDA clearance[13] - The company is focused on expanding international sales and improving operational efficiencies as part of its future growth strategy[20] Capital Expenditures - Capital expenditures increased from $3,797,000 in 2024 to $4,197,000 in 2025, reflecting a rise of approximately 10.5%[16] Acquisition-Related Considerations - The acquisition-related contingent consideration obligation was recorded at $18,380,000 in 2025, indicating ongoing strategic investments[15] - The change in fair value of acquisition-related contingent consideration was $4.570 million for the year 2025[24]

Core Insights - OraSure Technologies, Inc. reported Q4 2025 revenues of $26.8 million, which exceeded the midpoint of their guidance range, despite a 29% decline year-over-year [2][10] - The company anticipates a return to growth in 2026, driven by new product launches and regulatory clearances [2][10] Financial Performance - Total net revenues for Q4 2025 decreased by 29% to $26.8 million from $37.4 million in Q4 2024 [10] - Core business revenues (excluding COVID-19 and other specific testing revenues) were $26.7 million, down 22% year-over-year [3][10] - Gross profit for Q4 2025 was $10.97 million, with a gross margin of 41.0%, compared to 36.2% in Q4 2024 [4][10] - Operating loss for Q4 2025 was $20.1 million, compared to a loss of $12.4 million in Q4 2024 [4][10] Business Developments - The company is progressing on its innovation roadmap, including the submission of applications for FDA clearance for a rapid molecular self-test for Chlamydia and Gonorrhoeae, and the Colli-Pee™ at-home urine collection device [2][10] - Cash and cash equivalents stood at $199 million as of December 31, 2025, with $5 million allocated for share repurchases [10][13] Financial Guidance - For Q1 2026, the company projects total revenues between $26 million and $29 million, with minimal contributions from COVID-19 testing [7]

Financial Performance - In the first quarter of 2025, the total revenue was $29.9 million, and the company held an earnings call to discuss core business progress [1]. Company Actions - On May 21, 2025, the company submitted a mixed shelf registration application to the U.S. Securities and Exchange Commission, planning to raise up to $300 million, potentially for future business expansion or capital operations [2]. Analyst Ratings - Evercore maintained a "Hold" rating for the company in May 2025, with a target price of $3, indicating that the business performance met expectations [3].