OraSure Technologies (OSUR) investor relations material

Executive summary

• Q4 2025 revenue was $26.8 million, above the midpoint of guidance but down 29% year-over-year due to declines in core and COVID-19-related revenues.

• 2025 was a transition year with external headwinds and uncertain funding, but signs of stabilization are emerging in 2026, especially in key segments and international markets.

• Two major product launches are planned for mid-2026: a rapid molecular self-test for Chlamydia and Gonorrhea (CT/NG) and the Colli-Pee at-home urine collection device, both submitted to the FDA in December.

• Integration of the BioMedomics acquisition is progressing well, expanding the rapid diagnostic portfolio, especially with the Sickle SCAN test for Sickle Cell Disease.

• The company continues to invest in innovation and execute a $40 million share repurchase program.

Financial highlights

• Q4 2025 total revenue was $26.8 million; core revenue (excluding COVID-19) was $26.7 million, above the midpoint of guidance.

• Diagnostic products generated $15.1 million and sample management solutions $9.1 million in Q4.

• GAAP gross margin was 41% (up from 36.2% in Q4 2024); non-GAAP gross margin was 41.4%.

• GAAP operating loss was $20.1 million; non-GAAP operating loss was $15.2 million.

• Ended the year with zero debt and $199 million in cash and equivalents.

Outlook and guidance

• Q1 2026 revenue guidance is $26 million–$29 million, with negligible COVID-19 testing revenue.

• Gross margin for Q1 expected in the low 40% range, with sequential improvement from Q4 2025.

• Revenue ramp from new product launches anticipated in the second half of 2026.

• Management expects growth in 2026, supported by new product launches and regulatory approvals.

• Operating cash flow expected to return to breakeven as the company enters 2027.