OraSure sign at manufacturing site Eaton Avenue in Bethlehem

BETHLEHEM, Pa.- OraSure Technologies (OTI) continues to struggle in a post-pandemic world, but the Bethlehem-based maker of home diagnostic tests and sample management solutions is finding reasons to stay positive.

The company reported its first quarter 2025 financial results on Thursday. Total net revenues decreased 45% to $29.9 million from $54.1 million in the first quarter of 2024. OTI attributed the loss primarily due to a decline in COVID-19 revenues, which decreased 98% year-over-year.

OraSure also saw a GAAP (Generally Accepted Accounting Principles) net loss of more than $16 million, compared to a $3.5 million loss during the same period last year.

Core revenue (all revenues excluding COVID-19 and Molecular Services revenues) decreased 2% on a year-over-year basis and was flat compared to the prior year, after adjusting for the company’s previously announced exit from the risk assessment testing business.

Earnings per share (EPS) were down 21 cents.

But President Carrie Eglinton Manner said OraSure continues to make progress on its three pillars of transformation, “strengthening our foundation, elevating our core growth, and accelerating profitable growth.”

Headwinds in the U.S.

Eglinton Manner noted that headwinds in the U.S. have gotten stronger over the last few months. “Public health organizations at the federal, state, and local levels in the U.S. are dealing with elevated uncertainty given potential cuts to their budgets and significant reductions in staffing at HHS, CDC, and other agencies that administer public health programs,” she said.

One concrete example of the impact of those cuts, is the end of the Together TakeMeHome program, which provided the company’s OraQuick HIV Self-Tests at no cost to promote community testing. Eglinton Manner said the program will cease later this year, due to staff and budget cuts at the CDC. “We are working with our partners in the program, as well as the broader HIV and public health communities, to explore alternative avenues to continue this meaningful work,” she said.

OTI's revenue from the TakeMeHome program was $8 million in 2024, and is expected to be approximately $4 million in 2025.

Bringing more manufacturing to Bethlehem

The impact of increasing tariffs on OraSure is “minimal” for now, Eglinton Manner said. OTI has been helped by previously announced plans to shift more manufacturing from Canada to Pennsylvania. “We are currently capable of producing more than half of all global SMS (supply management solutions) volumes in our Bethlehem, Pennsylvania facilities and by the end of Q2, we will be capable of producing the vast majority of SMS volume in Pennsylvania,” she said.

That in-house manufacturing is expected to ramp up in the second half of this year, and into 2026.

OraSure has sites at 150 Webster Street in Bethlehem, where it houses its corporate offices and research and development; as well as a manufacturing facility at 220 E. First Street in Bethlehem; and manufacturing and warehouse space at 2685 Opus Way in Bethlehem Township.

Its original 30,501 square-foot facility at 1745 Eaton Avenue in Bethlehem has been listed for sale since last year.

Innovation

OraSure noted that its saliva collection technology, already used in tests for diseases like HIV and COVID-19, was used in a study that looked at the effectiveness of an at-home test to identify men at high risk for prostate cancer. The study, named Barcode 1, was carried out by the Institute of Cancer Research London and the Royal Marsden NHS Foundation Trust.

Also, the company is aiming to submit its Colli-Pee urine collection device for FDA clearance this year. Eglinton Manner said the technology plays a crucial role in Color Health’s new at-home cervical cancer risk screening test, which recently received approval from the New York State Department of Health.

Looking ahead

OraSure is guiding to second quarter total revenue of $28.5 million to $32.5 million, and core revenue of $28 million to $32 million.

“Overall, we are confident that OTI has the capabilities, products, customer relationships, commercial channels, and strong balance sheet to emerge from the current environment as a stronger enterprise, one that thrives while delivering on the purpose that motivates us,” said Eglinton Manner, in her closing remarks.


In the markets

Shares of OraSure stock (NASDAQ: OSUR) closed at $2.79 on Thursday. They are trading in the middle of their 52-week range, but have been on a consistent decline since January of 2024.

The company has a market capitalization of about $216 million.