[Second Quarter 2025 Financial Results Overview](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results%20Overview) 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](index=1&type=section&id=CEO%20Commentary%20and%20Strategic%20Focus) 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](index=2&type=chunk) - The company team is focused on advancing the innovation roadmap, expanding commercial reach, and diversifying customer relationships in new areas[3](index=3&type=chunk) - 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](index=3&type=chunk) [Key Financial Highlights (Summary)](index=1&type=section&id=Key%20Financial%20Highlights%20(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](index=7&type=chunk) - The company repurchased **1.8 million shares** of common stock for **$5 million** during Q2[7](index=7&type=chunk) [Detailed Financial Performance](index=1&type=section&id=Detailed%20Financial%20Performance) 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](index=1&type=section&id=Consolidated%20Net%20Revenues) 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](index=7&type=chunk) [Revenue by Business Segment (Q2 and YTD)](index=1&type=section&id=Revenue%20by%20Business%20Segment%20(Q2%20and%20YTD)) 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](index=7&type=chunk) - The decline in sample management solutions revenues was attributed to a large customer in the consumer genomics sector[7](index=7&type=chunk) [Gross Profit and Margins](index=2&type=section&id=Gross%20Profit%20and%20Margins) 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](index=7&type=chunk) [Operating Performance](index=2&type=section&id=Operating%20Performance) 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](index=15&type=chunk) - Research and development expenses increased to **$11.4 million** in Q2 2025 from **$6.6 million** in Q2 2024[15](index=15&type=chunk) [Net Loss and Earnings Per Share (EPS)](index=2&type=section&id=Net%20Loss%20and%20Earnings%20Per%20Share%20(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](index=2&type=section&id=Balance%20Sheet%20and%20Cash%20Flow%20Summary) 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](index=7&type=chunk)[18](index=18&type=chunk) [Recent Business Developments](index=3&type=section&id=Recent%20Business%20Developments) 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](index=3&type=section&id=Product%20and%20Partnership%20Updates) 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](index=14&type=chunk) - 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](index=14&type=chunk) [Executive Appointments](index=3&type=section&id=Executive%20Appointments) 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](index=14&type=chunk) [Financial Outlook](index=3&type=section&id=Financial%20Outlook) 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](index=3&type=section&id=Q3%202025%20Revenue%20Guidance) 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](index=4&type=section&id=Unaudited%20Financial%20Statements) 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)](index=4&type=section&id=Results%20of%20Operations%20(Income%20Statement)) 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](index=4&type=section&id=Consolidated%20Net%20Revenues%20Breakdown) 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](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) 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](index=18&type=chunk) [Non-GAAP Financial Measures](index=10&type=section&id=Non-GAAP%20Financial%20Measures) 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](index=10&type=section&id=Explanation%20of%20Non-GAAP%20Measures) 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](index=23&type=chunk) - 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](index=23&type=chunk) - Management also uses non-GAAP financial measures to develop budgets and manage the company's business[23](index=23&type=chunk) [GAAP to Non-GAAP Reconciliation](index=11&type=section&id=GAAP%20to%20Non-GAAP%20Reconciliation) 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](index=25&type=chunk)[26](index=26&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section provides background on OraSure Technologies, outlines forward-looking statements, and details the conference call for Q2 2025 results [About OraSure Technologies](index=9&type=section&id=About%20OraSure%20Technologies) 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](index=20&type=chunk) - 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](index=20&type=chunk) [Forward-Looking Statements](index=9&type=section&id=Forward-Looking%20Statements) 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](index=21&type=chunk) - 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](index=21&type=chunk) - Readers are cautioned not to place undue reliance on forward-looking statements, and the company undertakes no obligation to update these statements[22](index=22&type=chunk) [Conference Call Details](index=3&type=section&id=Conference%20Call%20Details) 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](index=10&type=chunk) - 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](index=11&type=chunk) - Participants interested in asking questions during the conference call are required to pre-register via the provided link[12](index=12&type=chunk)

Core Insights - OraSure Technologies, Inc. reported a significant decline in total net revenues for Q2 2025, decreasing 43% to $31.2 million from $54.3 million in Q2 2024, primarily due to a drop in COVID-19 related revenues [11] - The company is focused on expanding its product portfolio and has launched a new blood collection device for proteomic research, indicating a strategic shift towards innovation and diversification [2][3] - The company’s strong balance sheet, with cash and cash equivalents of $235 million as of June 30, 2025, provides flexibility for investments in growth opportunities [11] Financial Performance - Core business revenues decreased by 5% year-over-year to $30.8 million, while diagnostics revenues increased by 3% to $19.2 million [11] - Gross profit for Q2 2025 was $13.2 million, with a gross margin of 42.1%, down from 45.4% in Q2 2024 [11] - The operating loss for Q2 2025 was $18.0 million, compared to a loss of $2.7 million in Q2 2024, indicating a significant deterioration in operational performance [11] Recent Developments - The company launched the HEMAcollect™●PROTEIN product in July 2025, aimed at enhancing proteomic research capabilities [11] - A renewed customer agreement with GeneDx was announced, which will facilitate early diagnosis of rare pediatric diseases [11] - Anne Messing was appointed as Chief Commercial Officer, tasked with expanding sales, marketing, and product management efforts [11] Financial Guidance - The company anticipates Q3 2025 total revenues to be between $27 million and $30 million, with minimal contributions from COVID-19 testing revenues [7]

Core Insights - OraSure Technologies, Inc. has appointed Anne Messing as Chief Commercial Officer, bringing over 25 years of experience in the healthcare industry [1][2] - Ms. Messing will oversee Sales, Marketing, Strategic Alliances, and Product Management, aiming to enhance OTI's market leadership and long-term growth [2][4] - The company focuses on improving healthcare access, quality, and value through innovative diagnostic tests and sample management solutions [5] Company Background - OraSure Technologies is a leader in point-of-need and home diagnostic tests, as well as sample management solutions [1][5] - The company, along with its subsidiaries, develops and distributes rapid diagnostic tests and sample collection devices globally [5] - OTI's products are utilized by various sectors, including clinical laboratories, hospitals, and direct consumers [5] Leadership Experience - Prior to joining OTI, Ms. Messing held a significant role at Becton Dickinson, where she led initiatives that exceeded market benchmarks [3] - Her extensive background includes leadership positions at Danaher, Quest Diagnostics, Siemens Healthcare Diagnostics, and ARUP Laboratories [3] - Ms. Messing has a strong foundation in healthcare, starting her career as a certified medical technologist [3] Strategic Vision - The company aims to leverage Ms. Messing's expertise to drive growth and deliver exceptional value to stakeholders [4] - OTI is preparing for impactful product launches as part of its strategic vision for the future [4]

Core Insights - OraSure Technologies (NASDAQ: OSUR) is currently trading close to its cash value and has virtually no debt, resulting in a very low enterprise value (EV) [1] - The discounted pricing of the company is attributed to market perceptions rather than its fundamental value [1] Investment Philosophy - The company focuses on three main areas: analyzing high-quality growth companies with sustainable competitive advantages, turnaround situations and contrarian investments, and providing insights on broader market conditions and macroeconomic trends [1] - The educational background from the University of Virginia has provided rigorous analytical skills, emphasizing disciplined research and long-term perspectives [1] Market Position - The company is positioned to uncover emerging growth stories before they gain widespread attention, indicating a proactive investment strategy [1] - There is a commitment to sharing well-researched investment ideas and market insights to assist investors in making informed decisions [1]

Core Points - OraSure Technologies, Inc. has scheduled its earnings conference call for second quarter 2025 financial results on August 5, 2025, at 5 p.m. ET [1] - A webcast of the conference call will be available on OraSure's investor relations page and will be archived for approximately one year [2] - Participants interested in asking questions during the call must pre-register to receive access details via email [3] Company Overview - OraSure Technologies, Inc. focuses on transforming health through actionable insights and improving access, quality, and value of healthcare with innovative testing and sample management solutions [3] - The company, along with its subsidiaries, is a leader in developing, manufacturing, and distributing rapid diagnostic tests and sample collection devices for critical medical conditions [3] - OraSure's products are sold globally to various sectors including clinical laboratories, hospitals, and direct consumers [3]

Core Insights - OraSure Technologies, Inc. has launched the HEMAcollect™ ● PROTEIN product aimed at enhancing proteomic research through improved sample collection and preservation [1][2] - The HEMAcollect™ ● PROTEIN is an evacuated blood collection tube designed to stabilize plasma proteins for up to seven days, addressing limitations of traditional blood collection methods [1][2] - The product is expected to provide operational and financial efficiencies for proteomic researchers, facilitating high-quality data generation [1] Product Features - The HEMAcollect™ ● PROTEIN BCT utilizes ProteoPrecision™ technology to minimize hemolysis and platelet activation, ensuring sample integrity [2] - It is compatible with various proteomic technologies, including mass spectrometry and immunoassays, making it versatile for different research applications [2] Company Overview - OraSure Technologies focuses on transforming healthcare through innovative diagnostic tests and sample management solutions, serving a wide range of customers including clinical laboratories and pharmaceutical companies [4] - DNA Genotek, a subsidiary of OraSure, specializes in developing products that optimize sample collection and performance for high-quality biological samples [5]

Investment Rationale & Financial Strength - The company is an industry leader in rapid point-of-care infectious disease testing and DNA/RNA sample self-collection, stabilization, and preparation products[5] - The company has a strong balance sheet with over $178 million in cash and investments, no debt, and sustainable profitability[5, 63] Molecular Solutions Growth - Molecular solutions are experiencing growth from existing customers and increased demand from emerging genetic testing offerings and large studies[19] - In November 2017, the company announced a $143 million supply agreement for OrageneDx to a leading consumer genomics customer, over several years, with minimum annual purchase requirements[24] - The company's products drive scalability and access to donors in human genome testing[27] Infectious Disease Solutions & Market Opportunities - Approximately 36.7 million people are living with HIV, and there were 1.8 million new infections in 2016[46] - An estimated 71 million people globally have chronic hepatitis C infection, with approximately 399,000 deaths each year from HCV[56] - The company was awarded a $10.4 million BARDA contract for Ebola and $16.6 million BARDA contract for Zika[60, 61]

Financial Performance & Guidance - Q1 revenue reached $30.1 million, exceeding consensus estimates[10] - Q2 revenue guidance is projected between $40.0 million and $42.0 million, with net income of approximately $0.02 per share[11] - Full-year revenue guidance is set at $170 million to $175 million, with net income between $0.22 and $0.24 per share[11] - The company held $183.6 million in cash and investments as of March 31, 2019[11] Market Growth - Microbiome market revenue increased by 83% compared to Q1 2018[11] - Genomics sales in Asia increased by 231% compared to Q1 2018[11] - Domestic HCV revenues increased by 12% compared to Q1 2018[11] - International HCV sales increased by 119% compared to Q1 2018, primarily in Asia and Eastern Europe[11] Strategic Focus - The company is an industry leader in DNA/RNA sample self-collection, stabilization, and preparation products, as well as rapid point-of-care infectious disease testing[8] - The company is expanding further in established markets with strong demand for OraQuick HIV Self Test and OraQuick HCV test[8]

COVID-19 Related Opportunities - OraSure has multiple near-term COVID-19 opportunities, including two oral fluid self-collection devices for molecular testing that have received EUAs and CE-IVD marks[3] - The company is pursuing EUA for a lab-based oral fluid antibody test and developing a rapid antigen self-test[3] - OraSure is expanding manufacturing capacity to meet anticipated demand for COVID-19 tests, aiming to reach 55 million total tests per year by Q1 2021 and 70 million total tests per year by Q3 2021[28] - The company aims to increase total capacity for all molecular collection kits to 75 million units per year by Q2 2021 and 80 million kits per year by Q3 2021[29] - OraSure is also expanding capacity for Sars-Cov-2 Oral Fluid Antibody Tests from 10 million units per year to 20 million tests per year by Q4 2021[29] HIV Self-Testing - 21% of the 38 million people with HIV do not know their status, highlighting the need for accessible testing[32] - OraSure is the international HIV self-test market share leader with oral fluid self-collection and in-home results[33] - The Plan for America continues with $267 million in FY 2020 funding and a meaningful increase proposed for FY 2021 to end the HIV epidemic[35] Other Growth Drivers - Market leading microbiome products and services offer tremendous growth potential[3] - The company has $263.7 million in cash on the balance sheet with no debt, supporting ongoing business development activities[3] - Multiple research reports project mid-teens growth for the microbiome market from 2019-2024[39]

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]