OraSure Technologies Q3 Earnings Call Highlights

Key Points

• Q3 revenue grew 14% year over year to $30.9 million, supported by international HIV, hepatitis C and Sickle SCAN sales. Gross margins improved, while operating expenses declined sequentially; OraSure ended the quarter with $148.2 million in cash and no debt.
• OraSure pushed its operating cash flow breakeven target to the second half of 2027, from entering 2027, as product opportunities shifted and the company took a more conservative outlook after withdrawing its CT/NG self-test submission. It expects Q4 revenue of $30 million to $32 million.
• The company fulfilled initial orders for its FDA-authorized OraQuick Ebola 2.0 test and expects BRIDGE study results before year-end to potentially support broader regional adoption. It also launched its Colli-Pee Dx urine collection kit, while the regulatory path for the CT/NG self-test remains under discussion with the FDA.

OraSure Technologies NASDAQ: OSUR reported 14% year-over-year revenue growth in the third quarter of 2026, but pushed back its target for operating cash flow breakeven as the timing of several product opportunities shifted.

The diagnostics and sample collection company now expects to reach operating cash flow breakeven in the second half of 2027. Its earlier plan had targeted breakeven entering 2027 and included a meaningful contribution from a molecular self-test for chlamydia and gonorrhea, whose regulatory submission the company withdrew in August.

Third-quarter revenue rose to $30.9 million, up approximately 1% from the preceding quarter. Chief Financial Officer Ken McGrath said higher international HIV revenue, improved hepatitis C performance and growth in Sickle SCAN contributed to the year-over-year increase.

Revenue Growth and Lower Spending

Diagnostic product revenue rose 16% from a year earlier to $16.8 million. Sample management solutions revenue increased 21% to $12.5 million, helped by growth from commercial customers and the timing of orders.

GAAP gross margin expanded to 45.2% from 43.5% a year earlier. McGrath attributed the improvement to operational efficiencies and better overhead absorption, partially offset by geographic mix. Non-GAAP gross margin rose to 45.9% from 44.2%.

Operating expenses fell sequentially. Research and development spending declined by $1.8 million to $7.6 million as development-related spending tapered, while general and administrative expenses fell by $2.4 million to $12 million, partly because of lower nonrecurring legal and professional service costs. Sales and marketing expenses were relatively flat at $6.6 million.

OraSure posted a GAAP operating loss of $13 million and a non-GAAP operating loss of $10.2 million. It ended the quarter with $148.2 million in cash and cash equivalents and no debt. Operating cash flow was negative $10.9 million.

Outlook and Breakeven Target

For the fourth quarter, OraSure forecast revenue of $30 million to $32 million, representing approximately 12% to 20% growth from a year earlier. That range implies full-year revenue of $119.5 million to $121.5 million, or growth of 3.8% to 5.6%. The company expects fourth-quarter gross margin to be similar to or slightly below the third-quarter level.

McGrath said OraSure had identified opportunities, including potential demand for Ebola rapid testing, that it believed could offset much of the contribution originally expected from the CT/NG self-test. But as the timing of those opportunities changed, the company adopted more conservative estimates for reaching operating cash flow breakeven.

OraSure expects full-year revenue growth to accelerate in 2027 and plans to provide more detail on its fourth-quarter earnings call. McGrath said growth from both the existing business and new product launches would contribute to that acceleration.

Ebola and Other Product Developments

President and Chief Executive Officer Carrie Eglinton Manner said OraSure had fulfilled initial commercial orders for its OraQuick Ebola 2.0 rapid antigen test, which received U.S. Food and Drug Administration emergency use authorization in July. The test detects four Ebola virus species known to cause human disease, including Bundibugyo.

Eglinton Manner identified results from the BRIDGE Access Platform study as an important potential catalyst for broader adoption. The study, led by Africa CDC and the World Health Organization with Unitaid support, is evaluating diagnostic products for the current outbreak. Its evidence is intended to inform recommendations and regional decisions on registration and introduction of tests.

During the analyst question-and-answer session, Eglinton Manner said she had expected the study results sooner and that the company expected them before year-end, though the timing was not precise. She said the results could help open regional ordering. OraSure has launched local assembly in Uganda and plans to pursue a localized approach in Nigeria.

The company also launched its Colli-Pee Dx urine collection kit commercially during the third quarter, following FDA clearance in June. Eglinton Manner said initial sales were encouraging and that potential customers were evaluating how to incorporate self-collected urine into their testing programs.

On the InteliQuick CT/NG molecular self-test, Eglinton Manner said OraSure was working through the FDA pre-submission process to determine a regulatory path after withdrawing its prior submission. She did not provide a resubmission timeline, saying it depended on that process.

About OraSure Technologies (NASDAQ:OSUR)

OraSure Technologies, Inc develops, manufactures and markets diagnostic products and specimen-collection technologies used by healthcare providers, laboratories, researchers and consumers. The company focuses on making testing more accessible through products that support decentralized, point-of-care and at-home testing, as well as laboratory-based molecular and diagnostic workflows.

Its portfolio has included the OraQuick line of rapid diagnostic tests, including oral-fluid tests for HIV and hepatitis C, along with other infectious-disease testing products.

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