OraSure Technologies, Inc. Q4 FY2025 earnings call

2025 was a transition year, 2026 shows stability in key segments with near-term growth catalysts like mid-year product launches. International diagnostics: order trends stabilizing, Canada launch of HIV self-test, Biomedomics integration with strong demand for sickle scan. U.S. diagnostics: demand from public health customers stabilizing, OTC HIV self-tests in telehealth/direct-to-consumer. Sample management: positioned for growth in 2026 and beyond. Innovation pipeline: submitted rapid molecular self-test for CT and G and ColiP device application to FDA.

Total revenue in Q4 was $26.8 million, core revenue was $26.7 million. Diagnostic products generated $15.1 million revenue, sample management solutions revenue was $9.1 million. In international diagnostics, order trends in international diagnostics are stabilizing, Canada launched OraQuick HIV self-test, Biomedomics integration is going well. In U.S. diagnostics, demand from public health customers is stabilizing, OTC HIV self-tests have consistent demand. Sample management business is positioned to grow in 2026 and beyond, with genomic segments stabilizing and modest contributions from academic/government segments.

Q4 total revenue $26.8 million, core revenue $26.7 million. First quarter guided revenue $26 million to $29 million, gross margin in low 40% range, expected to improve slightly sequentially from Q4 2025. Expect to return to break even in operating cash flow by 2027 driven by revenue growth and cost savings.

Forward-looking statements may differ from actual results, affected by factors in SEC filings, OTI undertakes no obligation to update forward-looking statements.

Q: About R&D tapering off and redeployment.

A: Anticipate lower R&D expense full year, some clinical trials continue in Q1.

Q: On international HIV ordering cadence.

A: Improved visibility, countries in Africa figuring out funding and implementation.

Q: On two product launches FDA visibility.

A: Still working toward mid-year launch, regulatory review has uncertainty.

Q: On sample management growth.

A: Excluding large customer headwind, full year 2025 saw growth, driven by diversified customer base.

Q: On gross margin and revenue range.

A: Q1 gross margin low 40s, improvement expected as volume increases with absorption of fixed costs.

Q: On 2026 growth source.

A: Core business stabilization, product launches in second half, nearshoring opportunity in international