OraSure Technologies, Inc.

Good day, and thank you for standing by. Welcome to the OraSure Technologies 2025 Fourth Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today, Jason Plagman, Vice President of Investor Relations. Please go ahead.

Good afternoon, and welcome to OraSure Technologies' fourth quarter 2025 earnings call. Participating in the call today for OTI are Kerry Eglinton-Manner, our President and Chief Executive Officer, and Ken McGrath, our Chief Financial Officer. As a reminder, today's webcast is being recorded and the recording can be found on our investor relations website. Before we begin, you should know that this column may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share, and other financial performance, product development, performance, shipments and markets, business plans, regulatory filings and approvals, expectations and strategies. Actual results could be significantly different. Factors that could affect results are discussed more fully in OTI's SEC filings, its annual report on Form 10-K for the year ended December 31, 2024, its quarterly reports on Form 10-Q, and its other SEC filings. Although forward-looking statements help to provide more complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today. OTI undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I am pleased to turn the call over to Carrie.

Thanks, Jason, and thank you to everyone for joining us today. I'll discuss some highlights from Q4 and our key priorities for 2026 and beyond. As we discussed previously, 2025 was a transition year and we supported our customers in navigating a challenging and uncertain funding environment. As we enter 2026, we are seeing increasing signs of stability in key segments, including improved visibility to funding for important testing and research programs. And we are excited by several near-term catalysts for growth, including our two product launches planned for mid-year. One, our rapid molecular self-test for chlamydia and gonorrhea, also known as CT and G, and two, our Coli-P at-home urine collection device for sexually transmitted infections. Our submission of these two separate applications to the US FDA in December represents significant milestones on our innovation roadmap as we move into the next phase of our multi-year strategic transformation to deliver profitable growth and to create value for our customers and shareholders. Looking at our Q4 results, total revenue was $26.8 million and core revenue was $26.7 million, which was above the midpoint of our guidance range. In our international diagnostics business, Order trends are stabilizing as national health programs adapt to revised funding structures, including framework agreements that have been signed between the US and more than a dozen countries in Africa that incentivize greater levels of local investment in order to build more resilient and durable health systems. To that end, we are well underway establishing closer relationships with some of our existing distribution partners in Africa, including their in-country value-added assembly and manufacturing, also known as nearshoring. We believe that this trend represents an important opportunity in rebuilding health program momentum in countries around the globe and expect these expanded local relationships in Africa to begin to contribute revenue in Q1 and throughout 2026. We also expanded OTI's presence in Canada with the recent launch of our OraQuick HIV self-test following its receipt of a license from Health Canada. This test is Canada's first oral HIV self-test and we are excited to work with St. Michael's Hospital, Unity Health Toronto as the exclusive distributor of this test in Canada. Continuing with our international business, Our integration of Biomedomics is off to a good start following the close of the acquisition in November. We are seeing strong demand from existing customers for the sickle scan test, which is a rapid point of need test for sickle cell disease, or SCD. Our team is also building momentum with our initiatives to expand the reach and adoption of sickle scan, by leveraging our international sales channels and our existing relationships with national health programs, particularly in Africa where more than 385,000 babies are born each year with SCD, as well as in Latin America with its moderately high incidence of SCD and lack of newborn screening programs. In our U.S. diagnostics business, demand for our rapid tests from public health customers is stabilizing as those organizations adapt to the current funding environment at the federal and state level. We are also seeing consistent demand for our over-the-counter HIV self-tests from telehealth and direct-to-consumer online platforms that want to offer a reliable FDA-approved self-test that is authorized for use with oral fluid and is designed to meet the needs of individuals who wish to test themselves privately and painlessly at home. Switching gears to sample management, we remain confident that the sample management business is positioned to deliver growth in 2026 and beyond as genomic end segments continue to stabilize and gradually return to stronger growth, driven by clinical adoption of precision medicine. We also anticipate modest contributions to SMS revenue growth from the academic and government segments as NIH funding returns to a more regular cadence from international markets and from progress with our blood proteomic solution that we launched in mid-2025. Next, we'll transition to our innovation and product pipeline, which includes several important near-term catalysts for growth in attractive markets, as well as our pipeline of earlier stage opportunities in high-value growth markets that we discussed last quarter. Starting with Sherlock, we submitted a rapid molecular self-test for CT and G to the FDA in late December. As we've discussed previously, OTI's rapid self-test for CT and G is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable over-the-counter format. The test uses a self-selected swab, and results are intended to be read directly on the handheld testing device without the need for an electrical connection, enhancing accessibility and ease of use. OTI estimates that testing for CT and G represents a total addressable market of more than $1.5 billion. Today, the vast majority of CT and G tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of a convenient, private, and affordable rapid self-test. Also in December, OTI submitted a separate application to the FDA for clearance of our ColiP device for sexually transmitted infections, or STIs. The ColiP device which includes its proprietary stabilization chemistry, is designed for at-home urine collection, and is aligned with patient preferences for private and convenient diagnostic testing. The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the ColiP device for these indications would be in addition to the research use only product and is expected to expand access to testing while further strengthening OTI's leadership position in novel collection devices and chemistries. We anticipate that revenue from our product launches will ramp in the second half of the year. And these two submission milestones reflect meaningful progress on our innovation roadmap and demonstrate how we are advancing our vision to help decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. With that, I'll turn the call over to Ken to discuss our financial results and guidance.