ORASURE TECHNOLOGIES (OSUR) Company Report

OraSure Technologies reported Q4 2025 total revenue of $26.8 million and core revenue of $26.7 million, with a GAAP gross margin of 41% and a non-GAAP gross margin of 41.4%. The company ended the year with $199 million in cash and no debt.
The company submitted applications to the FDA in December 2025 for a rapid molecular self-test for chlamydia and gonorrhea (CT/NG) and the Colli-Pee at-home urine collection device for STIs, with revenue from these launches expected to ramp in the second half of 2026.
For Q1 2026, revenue is guided between $26 million and $29 million, with gross margin expected in the low 40% range. OraSure anticipates lower R&D expense for the full year 2026 and expects to return to breakeven operating cash flow by early 2027.
Strategic capital deployment in 2025 included $15 million for share repurchases and approximately $4 million for the BioMedomics acquisition in Q4, aimed at expanding its rapid diagnostic test portfolio and international reach. The company is also pursuing nearshoring opportunities in Africa expected to contribute revenue in 2026.

Feb 25, 2026, 10:00 PM

Transcript

OraSure Technologies Reports Q4 2025 Results and Outlines 2026 Growth Initiatives

OSUR

Earnings

Guidance Update

Product Launch

OraSure Technologies reported Q4 2025 total revenue of $26.8 million and core revenue of $26.7 million, with a GAAP gross margin of 41%.
The company ended 2025 with $199 million in cash and no debt, having repurchased $15 million of common stock for the full year.
For Q1 2026, revenue is guided to be between $26 million and $29 million, with gross margin expected in the low 40% range.
OraSure plans two mid-year 2026 product launches: a rapid molecular self-test for chlamydia and gonorrhea, and the Colli-Pee at-home urine collection device for STIs, both submitted to the FDA in December 2025. Revenue from these is expected to ramp in H2 2026.
The company anticipates lower R&D expense for the full year 2026 and expects to return to breakeven operating cash flow by 2027.

Feb 25, 2026, 10:00 PM

Transcript

OraSure Technologies Reports Q4 2025 Results, Guides Q1 2026, and Details Product Launch Plans

OSUR

Earnings

Product Launch

Guidance Update

OraSure Technologies reported Q4 2025 total revenue of $26.8 million and core revenue of $26.7 million, with a GAAP gross margin of 41%.
For Q1 2026, the company expects revenue between $26 million and $29 million and a gross margin in the low 40% range.
The company submitted FDA applications in December for two key product launches planned for mid-2026: a rapid molecular self-test for Chlamydia and Gonorrhea (CT/NG) and a Colli-Pee at-home urine collection device for sexually transmitted infections (STIs), with revenue expected to ramp in the second half of 2026.
OraSure Technologies ended 2025 with $199 million in cash and cash equivalents and zero debt, having repurchased $15 million worth of shares in 2025. The company anticipates returning to breakeven operating cash flow by early 2027.

Feb 25, 2026, 10:00 PM

Transcript

OraSure Technologies, Inc. Announces Q4 and Full Year 2025 Financial Results

OSUR

Earnings

Guidance Update

Share Buyback

OraSure Technologies, Inc. reported total net revenues of $26.8 million for Q4 2025, a 29% decrease year-over-year, and $115.0 million for the full year 2025, a 38% decrease from 2024. The company posted a GAAP net loss of $(19.3) million or $(0.27) diluted EPS for Q4 2025, and a GAAP net loss of $(68.7) million or $(0.94) diluted EPS for the full year 2025.
For Q1 2026, the company is guiding for total revenues between $26 million and $29 million and a Non-GAAP gross margin in the low 40% range. Management anticipates a return to growth in 2026.
As of December 31, 2025, OraSure Technologies, Inc. held $199 million in cash and cash equivalents and deployed $5 million in Q4 2025 to repurchase approximately 1.9 million shares, contributing to the $15 million deployed from its $40 million share repurchase program.
The company submitted applications to the FDA in December 2025 for clearance of its rapid molecular self-test for Chlamydia and Gonorrhoeae and its Colli-Pee™ at-home urine collection device for sexually transmitted infections.

Feb 25, 2026, 9:13 PM

8-K

OraSure Technologies Announces Fourth Quarter 2025 Financial Results

OSUR

Earnings

Guidance Update

Share Buyback

OraSure Technologies reported total net revenues of $26.8 million for the fourth quarter of 2025, a 29% decrease year-over-year, and a net loss of $(19.3) million or $(0.27) per diluted share. For the full year 2025, total net revenues were $115.0 million, a 38% decrease from 2024, with a net loss of $(68.7) million or $(0.94) per diluted share.
The company ended 2025 with $199 million in cash and cash equivalents.
OraSure deployed $5 million in the fourth quarter of 2025 to repurchase approximately 1.9 million shares under its $40 million share repurchase program.
The company provided Q1 2026 total revenue guidance of $26 million to $29 million.
In December 2025, OraSure submitted applications to the FDA for clearance of its rapid molecular self-test for Chlamydia and Gonorrhoeae and its Colli-Pee™ at-home urine collection device for sexually transmitted infections.

Feb 25, 2026, 9:05 PM

Press Release

OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Device for FDA Review

OSUR

Product Launch

New Projects/Investments

OraSure Technologies, Inc. submitted two separate applications to the FDA at the end of 2025 for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) and its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).
The CT/NG self-test, built on the Sherlock molecular diagnostics platform, is designed to provide results in approximately 30 minutes in an over-the-counter format, targeting a total addressable market estimated at over $1.5 billion.
The Colli-Pee™ device is intended for at-home urine collection for multiple STI indications, aiming to enhance access to private and convenient diagnostic testing.

Jan 5, 2026, 1:04 PM

8-K

OraSure Technologies Submits CT/NG Self-Test and Colli-Pee™ Device for FDA Review

OSUR

Product Launch

New Projects/Investments

OraSure Technologies (OSUR) submitted two applications to the U.S. Food and Drug Administration (FDA) at the end of 2025 for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) and its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).
The rapid CT/NG self-test is designed to provide results in approximately 30 minutes and targets a total addressable market estimated at over $1.5 billion.
The Colli-Pee™ device, intended for at-home urine collection for STIs, is expected to expand access to testing and reinforce OraSure's leadership in novel collection devices.

Jan 5, 2026, 1:00 PM

Press Release

OraSure Technologies Addresses Altai Capital's Director Nominations and Outlines Strategic Initiatives

OSUR

Board Change

Share Buyback

New Projects/Investments

OraSure Technologies confirmed that Altai Capital intends to nominate two candidates, including its founder Rishi Bajaj, for election to the Company's Board of Directors at its 2026 Annual Meeting of Stockholders.
The Company's Board previously evaluated Mr. Bajaj but determined not to appoint him, and has undergone significant refreshment, adding three new independent directors over the past three years, including Steven K. Boyd in October 2025 and appointing John P. Kenny as Chair in October 2025.
OraSure is executing a strategy to improve performance, focusing on advancing its innovation roadmap, consolidating operations, and improving margins, while maintaining a healthy cash position of $216 million with no debt as of September 30, 2025.
The Board initiated a new $40 million share repurchase program earlier this year, and the CEO and CFO adopted separate Rule 10b5-1 trading plans for common stock purchases.

Dec 17, 2025, 6:23 PM

Press Release

OraSure Technologies Board Nomination Announced by Altai Capital Management

OSUR

Board Change

New Projects/Investments

Demand Weakening

Altai Capital Management, a significant shareholder holding approximately 5.2% of OraSure's outstanding common stock, intends to nominate John Bertrand and Rishi Bajaj for election to the Board of Directors at the upcoming 2026 Annual Meeting of Stockholders.
The nomination is driven by OraSure's significant share price underperformance and the current Board's perceived failure in strategic and capital allocation decisions.
Altai criticizes OraSure's management for failing to turn around core product segments, making repeated ill-timed investments, and ineffectively deploying cash, which has resulted in a 25% reduction in cash and equivalents since 2023 and a 20% decline in quarterly revenue (excluding Covid-19 products) during the same period.

Dec 17, 2025, 1:00 PM

Press Release

OraSure Technologies Outlines Strategic Product Roadmap and Financial Outlook

OSUR

Product Launch

New Projects/Investments

Guidance Update

OraSure Technologies (OSUR) is celebrating its 25th year as a public company and is focused on its near-term product roadmap, particularly in molecular diagnostics following the acquisition of Sherlock. Key products include the CT/NG test for chlamydia and gonorrhea, targeting a $1.5 billion market, with FDA submission planned by the end of 2025 or early 2026 and a potential mid-2026 launch. The company also plans to submit its ColiP STI device for FDA approval around the same timeframe.
The company reported a cash balance of $216 million. While 2025 was a transition year due to government funding uncertainty, OSUR's core business is currently break-even, and they anticipate reaching overall company break-even by 2027 or 2028. They expect to achieve 50% plus gross margins in the out years, driven by increased volume leveraging existing manufacturing capacity.
OSUR's capital allocation priorities are innovation (both organic and inorganic) and share repurchases. Recent inorganic growth includes the acquisition of BioMedomics for rapid sickle cell testing, which currently generates $1 million in revenue and is expected to grow to a couple of million in a couple of years. The biggest growth engines for the next three to five years are identified as STIs, liquid biopsy, and infectious disease.