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    OSUR
    Earnings call· Jun 2026(Q2 FY26)

    ORASURE TECHNOLOGIES Q2 FY26 earnings call OSUR

    Aug 5, 2026 Source

    Executive summary

    OraSure Q2 FY26 — Strong Revenue, Margin Expansion, and Pipeline Progress Despite InteliQuick Delay

    OraSure delivered a strong Q2 FY26, surpassing revenue guidance and expanding gross margins, driven by sequential growth in both Diagnostic Products and Sample Management Solutions. While the InteliQuick CT/NG test faces a regulatory delay, the company remains confident in its pipeline, including recent FDA clearances for Colli-Pee Dx and OraQuick Ebola 2.0, and is focused on achieving operating cash flow breakeven by early 2027 through disciplined execution and strategic launches.

    Highlights

    5

    • Total revenue of $30.6 million exceeded guidance and grew 9.7% sequentially.

    • GAAP gross margin expanded 120 basis points sequentially to 43.5%.

    • Non-GAAP gross margin increased to 44.2% from 43.4% sequentially.

    • FDA clearance received for Colli-Pee Dx urine collection kit for 8 STI indications.

    • FDA Emergency Use Authorization granted for OraQuick Ebola 2.0 rapid antigen test.

    Concerns

    3

    • InteliQuick CT/NG test FDA clearance and U.S. launch delayed beyond 2026 due to withdrawal of submission for resubmission.

    • Operating cash flow was negative $9.9 million in Q2.

    • Year-over-year increase in G&A expenses due to nonrecurring legal and professional service costs related to proxy and stockholder activism.

    Guidance & targets

    4
    CategoryTargetConfidence
    Q3 Revenue
    $29.5 million to $32.5 million
    high materiality
    High
    Q3 Gross Margin
    similar to Q2
    medium materiality
    High
    Cash Flow from Operations
    breakeven
    high materiality
    High
    Revenue Growth
    growth
    high materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    Diagnostic Products
    Revenue was higher in the U.S. than international. Growth driven by stronger public health demand, customer purchasing tied to fiscal year cycles, higher syphilis revenue, and the addition of BioMedomics' Sickle SCAN.
    		$19.4 million—14.7%—
    Sample Management Solutions (SMS)
    Growth across segments, including commercial advanced diagnostic testing laboratories, microbiome collection, and early signs of recovery in academic and research channels. Anticipated contribution from Colli-Pee Dx.
    		$9.9 million—9%—

    Operational metrics

    11
    Total Revenue Growth (sequential)
    9.7%sequential
    Q2 FY26

    Total revenue exceeded guidance range.

    GAAP Gross Margin
    43.5%increased 120 bps sequentially
    Q2 FY26

    Expansion driven by lower scrap and operational efficiencies, partially offset by revenue mix.

    Non-GAAP Gross Margin
    44.2%increased from 43.4% sequentially
    Q2 FY26

    Expansion driven by lower scrap and operational efficiencies, partially offset by revenue mix.

    Non-GAAP Operating Loss
    $14.7 million
    Q2 FY26

    Reported non-GAAP operating loss for the quarter.

    Cash and Cash Equivalents
    $161 million
    Q2 FY26 end

    Balance sheet position at the end of the quarter.

    Share Repurchase (Q2 FY26)
    $2 million
    Q2 FY26

    Amount deployed for share repurchases during the quarter. Additional repurchase activity paused to prioritize balance sheet flexibility.

    Share Repurchase (Program Total)
    $22 million
    since program initiation

    Total amount returned to shareholders through repurchases since the program began.

    Sickle SCAN Revenue Growth
    twice as fastvs 2025
    2026

    Growth observed after integrating Sickle SCAN into international commercial channels.

    R&D Expense Trend
    declinedsequentially and year-over-year
    Q2 FY26

    Reflecting the tapering of launch preparation and production readiness spending for Colli-Pee device.

    G&A Expense Trend
    increasedyear-over-year
    Q2 FY26

    Primarily driven by nonrecurring items, including higher legal and professional service costs related to proxy and stockholder activism. Expected to decline to more normalized levels beginning in Q3.

    Contingent Consideration Liability Reduction
    —
    Q2 FY26

    Recorded as a result of updating the submission plan for the CT/NG test to incorporate FDA feedback. This reduction will offset incremental costs for resubmission.

    Industry KPIs

    3
    MetricValueDetails
    New product launch rampColli-Pee Dx and Ebola 2.0 Rapid Test
    FCF conversion leverage guidance0debt
    Pivotal trial clinical evidence milestonesFDA Clearance

    Product announcements

    2
    ProductTypeDetails
    Colli-Pee Dx urine collection kitlaunch
    OraQuick Ebola 2.0 rapid antigen testlaunch

    Deals & partnerships

    3
    BioMedomicsIntegration of Sickle SCAN into international commercial channels

    Progress following the acquisition of BioMedomics with Sickle SCAN, pursuing opportunities with national health programs in geographies with unmet sickle cell testing needs.

    BARDADevelopment of OraQuick Ebola 2.0 rapid antigen test

    OraQuick Ebola 2.0 rapid antigen test was developed in partnership with BARDA, building on the previous version.

    RocheColli-Pee Dx urine collection kit for use with Roche's Cobas molecular diagnostic platform

    FDA clearance of OTI's Colli-Pee Dx collection device with NucleoPrecision technology for use with Roche's STI test on its Cobas platform, increasing access to STI testing.

    Risks & headwinds

    3
    InteliQuick CT/NG regulatory delaybeyond 2026

    FDA clearance and U.S. launch delayed beyond 2026

    Mitigation: Working with FDA on resubmission, incorporating feedback; confidence in product performance remains high; financial impact offset by reduced milestone payments.

    Increased G&A expensesQ2 FY26

    Year-over-year increase in Q2 FY26

    Mitigation: Primarily due to nonrecurring legal and professional service costs related to proxy and stockholder activism; expected to decline to more normalized levels beginning in Q3.

    Federal funding pressure for HIV testing programsongoing

    Continued pressure

    Mitigation: HIV testing remains an important public health priority; strong demand for OraQuick HIV Self-Test; diversifying channels (consumer, B2B2C, telehealth).

    What to watch in Q3 FY26

    4

    InteliQuick CT/NG Resubmission Timing

    next quarter
    CurrentSubmission withdrawn, plan for resubmission being built
    TargetUpdate on specific timing for resubmission and potential approval

    Why it matters

    The InteliQuick CT/NG test is a key pipeline asset, and its regulatory path and market entry timing are critical for future growth and investment thesis.

    We will provide additional updates on our progress in future quarters as we move quickly to complete the work we think is necessary for regulatory clearance and full market launch.

    Q&A highlights

    2

    Given the InteliQuick CT/NG test submission withdrawal, what is the revised timing for resubmission and approval, and how will this affect the cost structure, particularly regarding post-approval studies and the contingent payment?

    Management confirmed plans to resubmit the InteliQuick CT/NG test after incorporating FDA feedback, but could not provide specific timing yet. They clarified that any incremental costs for resubmission will be offset by a reduction in the $20 million contingent consideration liability, ensuring no incremental impact on cash flow from operations.

    “As far as the cost, this will not incrementally add to our overall cash flow from operations usage. There's an offset here related to the milestone payments that will be reduced.”

    asked by Steven Etoch · answered by Kenneth McGrath

    2 min read6 chapters

    Detailed Narrative

    01

    Q2 Performance Highlights and Strategic Transformation

    OraSure reported Q2 FY26 total revenue of $30.6 million, exceeding guidance, and saw sequential GAAP gross margin expansion to 43.5%. The company is undergoing a multi-year transformation, shifting from restructuring to focused growth, with 2026 identified as a transition year. Key milestones include FDA clearance of Colli-Pee Dx and EUA for OraQuick Ebola 2.0, positioning the business for sustainable growth and long-term shareholder value.

    02

    InteliQuick CT/NG Regulatory Update and Impact

    The FDA clearance and U.S. launch of the InteliQuick CT/NG test are delayed beyond 2026. OraSure elected to withdraw its submission to incorporate FDA feedback and plans to resubmit. Despite the delay, management expressed high confidence in the test's performance and market potential, emphasizing that this does not alter the company's 2026 revenue growth or 2027 operating cash flow breakeven targets. The cost impact of the delay is expected to be offset by reduced milestone payments.

    03

    International Diagnostics Evolution

    The International Diagnostics business is strategically evolving to stabilize, diversify, and localize. This includes continued service to HIV testing customers, expansion of the portfolio, and deepening partnerships. Recent progress highlights include the OraQuick Ebola 2.0 Rapid Test authorization, near-shoring and in-country value-added assembly programs for OraQuick HIV Self-Test, and the successful integration and growth of Sickle SCAN, which is growing twice as fast in 2026 as in 2025.

    04

    U.S. Diagnostics Performance and Market Trends

    U.S. Diagnostics experienced stronger public health demand in Q2, influenced by customer purchasing patterns tied to fiscal year cycles. Demand for the OraQuick HIV Self-Test remained strong, benefiting from the syndemic testing approach across HIV, HCV, and syphilis. Consumer and B2B2C channels, including telehealth, continue to grow, reinforcing demand for convenient, private access to diagnostic testing and supporting future OTC and decentralized STI testing opportunities.

    05

    Sample Management Solutions (SMS) Growth and Innovation

    SMS revenue increased sequentially in Q2, driven by improvements across commercial advanced diagnostic testing laboratories, precision healthcare applications like microbiome collection, and early recovery in academic/research channels. The FDA clearance of Colli-Pee Dx, which incorporates NucleoPrecision chemistry for STI testing with Roche's Cobas platform, represents a significant innovation milestone and is off to a strong start with customer interest.

    06

    Financial Overview and Capital Allocation

    OraSure ended Q2 with $161 million in cash and no debt. The company repurchased $2 million of common stock (647,000 shares) in Q2, bringing the total to $22 million (7.7 million shares) since program inception, utilizing 55% of the $40 million authorization. Share repurchases were paused to prioritize balance sheet flexibility for launch-related investments. Operating cash flow was negative $9.9 million, consistent with expectations, with a target to reach breakeven by early 2027.

    AI-generated summary of the company’s earnings call. Not investment advice.