Q4 Revenue Beat and Core Revenue
Total revenue of $26.8 million in Q4 2025; core revenue (ex-COVID) $26.7 million, above the midpoint of guidance.
Segment Revenue Detail
Diagnostic Products revenue of $15.1 million and Sample Management Solutions revenue of $9.1 million in Q4, both consistent with expectations.
Improved Gross Margins Year-over-Year
GAAP gross margin improved to 41.0% in Q4 2025 from 36.2% in Q4 2024 (increase of 4.8 percentage points). Non-GAAP gross margin was 41.4% versus 40.1% in Q4 2024 (increase of 1.3 percentage points).
Strong Balance Sheet and Capital Return
Ended year with $199 million in cash and cash equivalents and zero debt. Share repurchases totaled $5 million in Q4 (1.9 million shares) and $15 million year-to-date (5.3 million shares) in 2025.
Two Major FDA Submissions and Near-Term Product Catalysts
Submitted two separate FDA applications in December: a rapid molecular OTC self-test for chlamydia/gonorrhea (Sherlock CT/NG) and the Colli-Pee at-home urine collection device for STIs. Management is targeting midyear launches with revenue ramp expected in H2 2026. Company estimates CT/NG TAM > $1.5 billion.
International Expansion and New Market Entry
Expanded presence in Canada with launch of OraQuick HIV Self-Test (first oral HIV self-test licensed in Canada) via exclusive distributor. Order trends in international diagnostics are stabilizing and nearshoring initiatives in Africa (in-country assembly/manufacturing) expected to contribute revenue starting in Q1 2026.
Acquisition Integration Progress
BiMedomics acquisition (≈$4 million investment in Q4) integration off to a good start, with strong demand for Sickle SCAN Sickle test and plans to leverage existing international channels (Africa, Latin America) to expand reach.
Operational Efficiency Moves
Completed major manufacturing consolidations (moving volumes into Bethlehem facility and internalizing ~95–97% of prior outsourced sample management volume), positioning the company to benefit from overhead absorption as volumes increase and expecting modest sequential gross margin improvement in Q1 2026 (low 40% range).