OraSure Technologies — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net revenues for the three months ended September 30, 2026, were $30.9 million, representing a 14% year-over-year increase; for the nine months ended September 30, 2026, revenues were $89.5 million, a 1% increase year-over-year.
• Core business revenues (excluding COVID-19 and Risk Assessment Testing) were $30.9 million in Q3 2026, up 14% year-over-year; for the nine months, core revenues were $89.4 million, up 4% year-over-year.
• Diagnostics revenues increased 16% year-over-year to $16.8 million in Q3 2026, driven by higher HIV and HCV revenues and sales from BioMedomics' Sickle SCAN®.
• Sample Management Solutions revenues were $12.5 million in Q3 2026, a 21% year-over-year increase, attributed to key commercial customer growth and order timing.
• GAAP gross margin improved to 45.2% in Q3 2026 from 43.5% in Q3 2025; Non-GAAP gross margin was 45.9% in Q3 2026 compared to 44.2% in Q3 2025.
• GAAP operating loss was $13.0 million in Q3 2026 compared to $16.1 million in Q3 2025; Non-GAAP operating loss was $10.2 million in Q3 2026 compared to $12.7 million in Q3 2025.
• GAAP net loss was $13.1 million in Q3 2026 compared to $13.7 million in Q3 2025; Non-GAAP net loss was $10.1 million in Q3 2026 compared to $9.8 million in Q3 2025.
• Diluted EPS was $(0.19) for Q3 2026, unchanged from Q3 2025; Non-GAAP diluted EPS was $(0.15) for Q3 2026 compared to $(0.13) in Q3 2025.
• Cash and cash equivalents were $148.2 million as of September 30, 2026, down from $199.3 million as of December 31, 2025.
• Deferred revenue was $0.7 million as of September 30, 2026, down from $1.5 million as of December 31, 2025.
• Net cash used in operating activities was $34.7 million for the nine months ended September 30, 2026, compared to $40.0 million in the prior year period.
• Capital expenditures were $5.0 million for the nine months ended September 30, 2026, compared to $3.3 million in the prior year period.

Guidance and Future Outlook:

• The Company guides Q4 2026 total revenues to be between $30.0 million and $32.0 million.
• Full-year 2026 revenue guidance implies a year-over-year growth rate of 4.7% at the midpoint of the range.
• The Company expects an acceleration of year-over-year total revenue growth in 2027 compared to 2026.
• Management stated they are well-positioned for continued revenue growth in Q4 2026 and into 2027, supported by a robust balance sheet.

Business Segments and Product Lines:

• Received initial orders for the Colli-Pee® Dx Urine Collection Kit, cleared for use with Roche's STI tests for Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium.
• Received initial orders for the OraQuick® Ebola 2.0 Rapid Antigen Test, authorized for use with whole blood in live patients and cadaveric oral fluid.
• Advanced early development of HPV testing as a potential future application for the Colli-Pee® Dx platform in collaboration with global molecular diagnostics partners.
• COVID-19 revenues were $22,000 in Q3 2026, a 75% decrease year-over-year; for the nine months, COVID-19 revenues were $41,000, a 93% decrease.
• Risk Assessment Testing revenues were $0 in Q3 2026; for the nine months, revenues were $0, a 100% decrease from $1.9 million in the prior year period.

Market and Competitive Landscape:

• The Company continues to execute a strategy to decentralize diagnostics and connect people to care that is accessible, convenient, affordable, and private.
• The Colli-Pee® Dx platform expansion aims to address unmet needs among under-screened populations in women's health.

Risks and Challenges:

• The press release notes that actual performance may differ from forward-looking statements due to factors including market acceptance, regulatory approval timing, customer purchase forecasts, manufacturing capabilities, and competition.
• Specific risks include reliance on strategic partners, potential disputes, ability to meet demand, and changes in testing guidelines or algorithms by agencies like the CDC.

Management Commentary and Tone:

• Carrie Eglinton Manner, President and CEO, stated that Q3 results demonstrate continued execution of the strategy, delivering double-digit revenue growth and meaningful gross margin expansion.
• Management highlighted operational efficiency initiatives that reduced the cost base.
• Management expressed excitement regarding the commercial launches of Colli-Pee® Dx and OraQuick® Ebola 2.0 translating into initial orders.
• Management affirmed a commitment to invest behind initiatives to accelerate topline growth, improve the operating model, and drive towards profitability.

Other Key Points:

• The Company repurchased $7.0 million of common stock during the nine months ended September 30, 2026, compared to $10.0 million in the prior year period.
• Proceeds from the exercise of stock options were $47,000 for the nine months ended September 30, 2026.
• The Company recorded a $22.5 million non-cash gain related to the change in fair value of acquisition-related contingent consideration for the nine months ended September 30, 2026.
• The Company recorded $1.3 million in workforce reduction severance and $0.8 million in executive severance expenses for the nine months ended September 30, 2026.
• The acquisition-related contingent consideration obligation was $0 as of September 30, 2026, down from $18.4 million as of December 31, 2025.
• The Company will host a conference call and audio webcast to discuss results beginning at 5:00 p.m. Eastern Time on the date of the release.