OraSure Technologies, Inc.

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the AutoSure Technologies Inc. 2025 third quarter earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star one. I would now like to turn the conference over to Jason Flagman, VP of Investor Relations. You may begin.

Good afternoon, and welcome to OraShare Technologies' third 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, 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'm pleased to turn the call over to Carrie.

Thanks, Jason, and thank you to everyone for joining us today. Today, I will discuss some highlights from Q3 and our progress on key priorities for 2025 and beyond. Overall, we continue to significantly advance our strategic transformation and execute with discipline as we position Orrisher for a return to growth in 2026. We have delivered meaningful progress and continue strengthening our foundation. We're also elevating our core growth by expanding and diversifying our product portfolio and customer relationships. Plus, we're accelerating profitable growth through investments in internal R&D, as well as acquisitions and partnerships that leverage our existing capabilities and that offer an attractive risk-adjusted ROI. Looking at our Q3 results, Total revenue was $27.1 million, and core revenue was $27.0 million, which included diagnostics revenue of $14.5 million and sample management revenue of $10.3 million. Broadly speaking, our key end markets remain mixed, and we continue to partner with customers that are navigating an environment with elevated levels of uncertainty related to funding for public health programs and research, as well as the government shutdown in the US. That said, we view 2025 as a transition year, and we're excited about pipeline opportunities in attractive markets that align with our strengths to drive growth in 2026 and beyond. In our international diagnostics business, We discussed on our last earnings call that we anticipated a slower pace of orders for our HIV tests 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. That trend played out as expected in Q3 and thus far in Q4. For the full year 2025, we now expect that revenue from our international diagnostics business will be in the low to mid $30 million range, representing a decline of approximately 20% compared to 2024, which was a record year for international diagnostics. Staying with our international business, we are pleased to share that OTI signed a definitive agreement to acquire Biomedomics. This tuck-in acquisition expands OTI's diagnostic portfolio by adding SickleScan, a rapid point of need test for sickle cell disease that is sold outside the U.S. The global sickle cell testing market, particularly in high burden regions and developing markets, is underserved and fragmented. We believe Sickle Scan addresses this need with a high quality, affordable, rapid point of care test. And there is support from government agencies and global health organizations to increase access to sickle cell testing at the point of need. We see an opportunity to expand the reach and adoption of sickle scan by leveraging OTI strength, including our international sales channels and our existing relationships with national health programs, particularly in Africa and Latin America. Furthermore, many of our international customers and partners have expressed interest in a reliable, low-cost, rapid diagnostic test for sickle cell disease. Transitioning to our U.S. diagnostics business. Our public health customers are adapting to significant reductions in staffing at HHS, CDC, SAMHSA, and other federal agencies that support public health programs, along with budgetary uncertainty and challenges related to the federal government shutdown. We are continuing, however, to see traction with our syndemic approach that leverages our portfolio of rapid tests across multiple conditions. And we are expanding our customer base in non-public health markets, such as urgent care, hospital, emergency rooms, and correctional facilities for rapid hepatitis C testing plus online channels specializing in consumer-initiated testing. Overall, for the full year 2025, we expect our U.S. diagnostics business to generate revenue in the low to mid $30 million range, representing a low single digit percentage decline compared to 2024. We also wanted to provide an update on Together Take Me Home, a collaboration funded by the federal government that makes HIV self-tests available through the mail, in order to advance the President's goal of ending the HIV epidemic. We are pleased to share that this highly effective, life-saving program was renewed by the Trump administration with strong bipartisan support in Congress. As a result, Together Take Me Home is continuing for program year four, which runs from October 2025 to the end of September 2026. We expect to recognize approximately $1.8 million of revenue from Together Take Me Home in Q4 and anticipate a similar pace of quarterly revenue in 2026. Switching gears to our sample management business, the overall trend continues to be mixed. SMS revenues increased on a quarter-over-quarter basis in Q3, but we anticipate a sequential decline in Q4. which is consistent with the typical seasonal ordering pattern for this business. For the full year, we expect revenue from sample management products in the high $30 million range, which would be approximately flat compared to 2024 if you exclude the impact of the decline in orders from a large consumer genetics customer. Looking ahead, we are confident that the sample management business is positioned to return to growth in 2026 and beyond, as genomic end segments gradually return to stronger growth, driven by clinical adoption of precision medicine. Our confidence is also supported by continued scientific and technological advancements, such as the increasing utilization of short read and long read genomic sequencing, the decline in unit cost for sequencing and analysis, and advancements in areas such as proteomics. We are also seeing early signs of positive trends in some international markets, such as the Middle East, that are planning to invest in population health studies using novel sample collection devices in order to accelerate precision health and life sciences research in the region. We're also pleased to share that the Endo 100 project has selected multiple kits from our Omnigene and Coli-P product lines for collection and stabilization of a variety of sample types, including saliva, urine, stool, and vaginal swab. The Endo1000 project is a United Kingdom-wide initiative aimed at accelerating discovery and advancing data-driven research into the diagnostics and personalized treatments of endometriosis. By collecting biological samples and lifestyle data from participants over two years, the study seeks to uncover patterns that can inform more effective individualized care strategies. The inclusion of our sample collection kits in this landmark study underscores their value in enabling high-quality research and positions us for continued growth in the precision health and clinical research segments. Now I'll transition to our exciting pipeline of innovation, including an update on several products targeting attractive markets. Mid-year, we launched a blood collection tube with stabilization chemistry for research use only, or RUO, markets in the burgeoning field of proteomics. We also anticipate near-term milestones for coli P urine collection. initially for sexually transmitted infection, or STI, indications, and future expansion into liquid biopsy. And our Sherlock molecular diagnostics rapid test platform, whose first assay is expected to serve the large and growing chlamydia and gonorrhea, or CT and G, segments of STI. As we discussed last quarter, our HEMA Collect protein product launched in July 2025 in the RUO market, like I just mentioned. Since this launch, we've received positive and insightful feedback from our customers and early adopters that will help inform our roadmap as we enhance our Proteomics product line and build additional momentum in 2026. Additionally, OTI is presenting at the upcoming Human Proteome Organization World Congress to highlight chemo collect proteins, proprietary stabilization capabilities, and its performance across a range of proteomics technology platforms. Moving to our ColiP device, which is designed for first void urine collection. We plan to submit clinical trial data to the FDA for STI indications by late 2025 or early 2026. Receipt of approvals for these applications subject to regulatory review would be in addition to our existing Coli-P RUO product and is expected to further strengthen our competitive position in novel urine collection. Our analytical and clinical studies are demonstrating strong performance and flexibility across multiple target analytes. We're in advanced discussions with leading diagnostics platform providers that are interested in enabling self-collected non-invasive testing across large and growing markets, including STIs, HPV, and other disease states. Next in product innovation, regarding our Sherlock over-the-counter molecular diagnostic self-test platform and its first assay for CT and G. We are making good progress in our clinical trial and our plan for submission to the FDA in late 2025 or early 2026. We anticipate gaining momentum for our product launches for innovation. And it's the work we've done in transforming our enterprise that also allows us to invest in creating a pipeline of earlier stage opportunities in high value growth markets that fit well with our strengths and our product platforms where we can compete and win. Examples include categories where we already have a presence, like an infectious disease and STIs, plus the newer ones like liquid biopsy or, say, antimicrobial resistance, where rapid tests and differentiated chemistries have outsized potential to create and add value. We look forward to sharing more details as new product opportunities progress through our development process. With that, I'll turn the call over to Ken to discuss our financial results and guidance.