5/6/2026

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to the OraSure Technologies Incorporated 2026 First 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 will 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. Be advised that today's conference call is being recorded. I would now like to hand the conference over to your first speaker today, Jason Plagman, Vice President of Investor Relations. Please go ahead.

speaker
Jason Plagman
Vice President, Investor Relations

Good afternoon, and welcome to OraSure Technologies' first quarter 2026 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 call 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, 2025, 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.

speaker
Kerry Eglinton-Manner
President and Chief Executive Officer

Thanks, Jason, and thank you to everyone for joining us today. Today I'll discuss some highlights from Q1 and provide updates on our key priorities for 2026. Overall, we continue to advance our strategic transformation and execute with discipline as we focus on driving growth in 2026 and beyond. We have delivered meaningful progress over the last few years and continue strengthening our foundation. including leveraging our manufacturing capabilities and capacity to drive gross margin expansion, while also streamlining our cost structure. We're also elevating our core growth by expanding and diversifying our product portfolio and customer relationships, while several of our key end markets adapt to an evolving funding environment. Ultimately, we're accelerating profitable growth through investments in R&D targeting high-value growth markets, as well as acquisitions and partnerships that leverage our existing capabilities and provide an attractive risk-adjusted ROI. We're also preparing for 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, or STIs. Looking at our Q1 results, total revenue was $27.9 million, which was above the midpoint of our guidance range, and we generated solid gross margin expansion. In our international diagnostics business, We made significant progress on our initiatives to establish closer relationships with some of our distribution partners in Africa and their in-country value-added assembly and manufacturing, also known as nearshoring. During Q1, we delivered on initial orders to one of our nearshoring partners. We anticipate initial orders from other partners in the second half of the year. And we believe this trend represents a significant opportunity in rebuilding momentum in health program implementation in countries around the globe. Additionally, our international team is building positive momentum with the integration of biomedomics into our sales channels and then expanding the reach of SickleScan into new markets through our relationships with national health programs. In our U.S. diagnostics business, our public health customers are stabilizing as they adapt to the current budget environment. In general, HIV testing programs remain a key priority for state and local public health agencies to control the spread of the virus and to manage downstream costs in the healthcare system. We are also seeing traction in demand resulting from our syndemic approach that leverages our portfolio of rapid tests across multiple conditions, including HIV, HCV, and syphilis, to deliver value and ease of use for customers. Switching gears to sample management solutions, we are seeing gradual improvement with commercial customers, including advanced genetic testing labs, driven by increasing utilization of precision medicine that leverages genetic insights to identify risk factors for cancer and other conditions, as well as diagnosis of rare diseases. During Q1, growth in commercial segments was offset by muted demand in academic and government markets related to the continued slow pace of NIH research grant funding. That said, we remain confident that the sample management business is positioned to deliver growth in 2026 and beyond as genomic end segments gradually return to stronger growth. Next, I'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. From a regulatory standpoint, our two applications for FDA clearances are in the review process. We continue to anticipate mid-year clearances and expect that revenue from product launches will ramp in the second half of the year. As a reminder, our two submissions were for our over-the-counter rapid self-test for CT and G that is built on the Sherlock molecular diagnostics platform. and our ColiP device for STIs. The ColiP submission, which includes its proprietary stabilization chemistry, covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. These two submissions, with their potential clearances, reflect our 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.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-