OraSure Technologies, Inc.

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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Jason Plagman, Vice President of Investor Relations. Please go ahead.

Good afternoon and welcome to Orchard Technologies' second 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 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 report on the 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. We are pleased to provide an update on the progress OTI is making on the three pillars of our strategic transformation. One, strengthening our foundation. Two, elevating our core growth. And three, accelerating profitable growth. Today, I'll discuss some highlights from Q2 and our progress on our key priorities for 2025 and beyond. A few notable developments include, we reported revenue in Q2 that was in the top half of our guidance range for both total revenue and core revenue. We continue to advance our innovation roadmap in order to expand our portfolio with new products. To that end, we launched our HEMA Collect protein offering in July in an effort to meet the evolving needs of proteomic researchers. This product also expands our sample management solutions into a new sample type, blood. Next, Anne Messing joined OTI this week as Chief Commercial Officer. She will be responsible for sales, marketing, and product management and will help shape the vision and management of our product portfolio with the aim to expand market leadership and to drive sustainable accelerated growth. And as we previewed last quarter, during Q2, we substantially completed the transition from external contract manufacturing of our SMS products outside of the U.S. to our internal capabilities in Pennsylvania. Looking at Q2, core revenue of $30.8 million was above the midpoint of our guidance range. Diagnostics grew 3% year over year and sample management revenue decreased 22% year over year, with a decline attributable to a large customer in the consumer genetics segment as we've discussed on prior calls. Excluding the impact of that customer, sample management revenue growth would have been positive on a year over year basis in Q2 and overall core revenue growth would have been 5% compared to the prior year. Broadly speaking, our key end markets remain mixed and we are staying closely aligned with our customers as they navigate an environment with improving but still elevated levels of uncertainty related to funding for public health programs as well as for research. In our international diagnostics business, we delivered year over year revenue growth in Q2 and the first half of 2025 despite unprecedented disruption due to USAID funding freezes for local distribution and implementation partners in many markets. Due to that disruption, the pace of deployment of HIV tests to end users in those geographies flowed considerably over the last six months as also recently referenced by other industry suppliers. We now expect a slower pace of international orders for our HIV test in the second half of the year as our in-country partners work through their existing inventory and national health programs adapt to changes in the funding environment. Longer term, we remain confident in our competitive positioning in the international HIV testing market due to several important factors. First, our unique oral fluid-based rapid test is preferred by patients. It's easy to use and interpret at the point of need and it requires fewer resources and clinical support than tests that are lab-based or require collection of a blood sample. And second, OTI has a history of proven success with 10 years of consistent leadership and strong enduring relationships with customers and partners. Of course, we are closely monitoring the situation and actively engaging across the ecosystem in order to deliver on life-saving tests to treat programs that remain critical to improving global health. In our U.S. diagnostics business, revenue has been relatively steady, declining 1% year over year in the first half of 2025. Many of our public health customers are dealing with elevated uncertainty given potential cuts to their budgets and significant reductions in staffing at HHS, CDC, and other agencies that administer health programs. In May, we discussed the pending wind down of Together Take Me Home, a federal program with strong bipartisan support in Congress that makes HIV self-tests available through the mail. Since then, program administrators have received a rescission of the closeout letter and Together Take Me Home may continue beyond the end of the federal fiscal year on September 30th. That said, program funding levels have not yet been communicated and we continue to actively monitor the situation, which remains fluid. We expect to recognize approximately half a million dollars of revenue from Together Take Me Home in Q3 compared to two million dollars in Q2 due to the timing of orders. We are hopeful that we will be able to continue our work with our partners in the program, which has delivered significant benefits since it launched three years ago, including reaching at-risk populations who had not previously understood their HIV status and are now engaged in testing and prevention or treatment that improves their quality of life and helps end the HIV epidemic. Switching gears to our sample management business, our commercial segment, which includes advanced diagnostic labs, pharma and biotech, and animal health companies, amongst others, grew in the first half of 2025, excluding the disruption we've experienced with our consumer genetics customer. In the academic and research segment, some of our customers have been negatively impacted by reductions in NIH funding, as we discussed last quarter. Looking ahead, we see continued stability in SMS revenue in Q3 and Q4. And specific to our large consumer genetics customer, we view the recent resolution of their ownership as a positive for everyone. Consistent with what we've shared, we do not anticipate any significant revenue from this customer in the second half of the year, and we think orders are more likely to resume in 2026. As we described last quarter, we continue to believe it's a matter of time when, not if, genomics end segments return to consistently stronger growth, driven by scientific advancements and greater clinical adoption of precision medicine. At the same time, we remain focused on maintaining strong customer relationships while cultivating new ones. As an example, we're pleased to announce the renewal of our agreement with GeneDx, a valued and long-standing customer. Our ORA Collect kits help enable early diagnosis of rare pediatric diseases through the use of GeneDx's exome and genome analysis. We're also pleased to highlight one of our newer relationships. With Targeted Genomics, the developer of GlutenID, the first and only U.S. FDA cleared -to-consumer test for celiac disease genetics. Celiac disease, the most common intestinal autoimmune disease worldwide, is triggered by dietary gluten in people who carry certain celiac risk genes. Individuals who test negative for these genes have less than a 1% chance for developing celiac disease. GlutenID assesses all 15 possible genetic combinations of the risk genes using DNA isolated from saliva and collected with our ORA Collect DX device. This test allows for at-home collection of saliva samples, simplifying the test process so patients can get actionable answers and ultimately relief. OTI is proud to collaborate with Targeted Genomics to make celiac disease screening more accessible and convenient for at-risk individuals and their families. In addition to expanding our customer relationships, we also continue to advance our innovation roadmap. As planned in July, we launched our HemaCollect Protein product. This blood collection device and chemistry has the potential to transform proteomic research and discovery through extended protein stabilization at room temperature and a simplified workflow and it is anticipated that use of the device for sample collection will deliver operational and financial efficiencies to researchers. The HemaCollect Protein Collection Kit is compatible with a broad range of proteomic technologies including mass specs, immunoassays, and high throughput affinity-based platforms. We believe our HemaCollect Protein offering represents a significant advancement in sample collection for proteomics and that it can support research and laboratory developed tests in rapidly growing applications such as oncology, neurology, cardiology, metabolic disorders, and beyond. Moving to our CALLiP device which is designed for first void urine collection, we're making strong progress toward our planned goal of a 2025 FDA submission. We're in active discussions with leading diagnostics platform providers seeking to expand in self-collected non-invasive testing across large and growing markets including sexually transmitted infections, HPV, and other disease states. These segments represent multi-billion dollar global TAMs and we see significant growth opportunities for CALLiP driven by patient preference for less invasive sample collection and increased demand for convenient, accessible, and private diagnostic options. For HPV specifically, CALLiP also addresses long-standing challenges with urine-based testing by enabling assay sensitivity and specificity comparable to invasive swaps, opening the door to broader, more inclusive screening programs. Meanwhile, oncology and liquid biopsy applications are also gaining momentum with urine emerging as a powerful new matrix for early cancer detection. Coupled with our proprietary DNA-RNA stabilization chemistry, CALLiP is uniquely positioned to power the next generation of high impact patient-centric diagnostics. Next in product innovation, our clinical study for Sherlock's first -the-counter molecular self-test for Chlamydia and gonorrhea, or CTNG, is progressing well. We remain on track to submit data to the FDA by the end of 2025. As a reminder, CTNG testing is the largest market within STIs and it requires molecular technology. Sherlock's CTNG test is truly disposable at-home test designed to deliver lab-like clinical performance with a rapid turnaround time at what we believe will be an attractive price point. Of the tens of millions of CTNG tests performed in the US each year, the vast majority are currently processed in a centralized lab. We are confident that the introduction of an affordable -the-counter test has the potential to drive incremental market adoption through improved access to convenient private testing options in a segment where privacy is a key priority. As I've described today, our team is making meaningful progress in advancing our innovation roadmap in order to expand our portfolio through new product launches, and we are also expanding and diversifying our client relationships in new segments. We expect our momentum to accelerate under the leadership of our new Chief Commercial Officer, Anne Messing. Anne brings more than 25 years of commercial leadership experience in life sciences, diagnostics, and clinical laboratory services. Prior to joining OTI, she was Vice President and General Manager of the US Region for Bechtin-Dickinson BD Biosciences. Anne's prior experience at Danaher, Quest Diagnostics, Siemens, and in Hawthorne Labs is both valuable and relevant for OTI and for our customers. Anne has a proven track record of driving growth, building high-performing sales teams, and transforming strategic vision into demonstrable results and sustainable success. We are excited to welcome Anne to our business and leadership team. With that, I'll turn the call over to Ken to discuss our financial results and guidance.