OSUR

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 5:00 p.m. ET Chief Accounting Officer - Michele Anthony President and Chief Executive Officer - Carrie Eglinton Manner Chief Financial Officer - Kenneth J. McGrath Operator: Good day, and thank you for standing by. Welcome to OraSure Technologies Inc. 26 second quarter earnings conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press *11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Michele Anthony, Chief Accounting Officer. Please go ahead. Michele Anthony: Thank you. Good afternoon, and welcome to OraSure Technologies Second Quarter 2026 Earnings Call. Participating in the call today for OTI are Carrie Eglinton Manner, our President and Chief Executive Officer and Kenneth 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, expectation and strategies. Actual results could be significantly different. Factors that could affect results are discussed more fully in OTIs 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. Carrie Eglinton Manner: Thanks, Michele, and thanks to everyone for joining us. Today, I will discuss some of the highlights from Q2, and provide updates on our key priorities for 2026. Q2 was another important quarter in OraSure's transformation. We exceeded our revenue guidance expanded gross margin sequentially, advanced our decentralized diagnostics pipeline in rapid tests and sample management solutions, and continue to position the business for sustainable growth and long term shareholder value in the second half of 2026 and beyond. Through our multiyear transformation, we have moved from restructuring and portfolio simplification to execution against a more focused growth strategy. In 2025, we said that 2026 would be a transition year on the path back to growth. Q2 demonstrated that transition beginning to take shape through stronger revenue, improving margins and meaningful innovation milestones. Including FDA clearance of Colli-Pee with its nuclear precision chemistry for use with Roche cobas STI test plus FDA emergency use authorization for our second generation OraQuick Ebola rapid test. Also on the innovation front, and an FDA update, is our IntelliQ CT/NG test on the SHERLOQ platform. While we remain very confident in and excited about this first-of-its-kind rapid molecular self-test. I would like to call out that we are no longer expecting FDA clearance and US launch to occur in 2026. I will provide additional details later on this. But I want to reiterate our conviction that it is an excellent test that performs very well. Following constructive conversations with FDA, however, we recently elected to withdraw our submission. We are incorporating feedback from the agency, and we will be working with them on resubmission to bring it to market. We have positive momentum on multiple fronts. And while we are disappointed in the IntelliQ delay, I want to emphasize this does not change our commitment or ability to deliver on revenue growth in 2026 or cash flow from operations breakeven as we enter 2027. We are strengthening our foundation by leveraging our Pennsylvania manufacturing capabilities. Insourcing work previously performed by third party contractors, and maintaining disciplined cost controls that are visible in our margin performance. We are elevating our core by diversifying the markets channels, and customers we serve across rapid diagnostics and sample management solutions, as evidenced in our sequential progress. We are accelerating profitable growth through targeted R&D and partnerships focused on high value markets where decentralized access, proprietary know how, scalable manufacturing, and accessible rapid testing and collection solutions can create attractive risk adjusted returns. Focusing on our Q2 results, Total revenue was $30.6 million exceeding our guidance range. And gross margins improved sequentially. Lapping the divestiture of our risk assessment testing business, and now with COVID almost entirely behind us, we are focused on growing our business. Executing launch readiness, for near term catalysts, and progressing toward operating cash flow breakeven as we enter 2027. The accomplishments we will highlight today are important proof points of that strategy. Moving to those highlights. In mid June, we announced FDA clearance of the Colli-Pee urine collection kit. Which enables at home self collection, of volumetric first void urine samples for STI testing, which can be collected at any time of day. We believe clearance of OTIs differentiated Colli-Pee collection device with its proprietary NUCLEO-PRECISION sample stabilization technology. Utilized with Roche's STI test on its COBOS molecular diagnostic platform. Can increase access, convenience, and privacy for important STI testing. It also represents a key milestone in our strategy to decentralize diagnostic solutions and connect more people to care while helping increase SMS portfolio growth. We also recently shared that we received FDA emergency use authorization for our OraQuick Ebola 2.0 rapid antigen test. Building on our Ebola 1.0 rapid antigen test, for which we received de novo authorization in 2019,, Our version 2.0 test was also developed in partnership with BARDA. The test detects all 4 Ebola virus species known to cause human disease. Including the Bundibugyo species driving the current outbreak in Central Africa. This authorization underscores OTI's strength in public health, including our R&D expertise, our regulatory capabilities, manufacturing scale, global reach, and long standing partnerships with governments and global health organizations. Together, these capabilities enable us to respond quickly to emerging and ongoing health threats. With accessible rapid diagnostic solutions. While this outbreak is a stark reminder, of the devastating impact of infectious diseases, it is another reminder that our mission and expertise matter. We are proud to contribute to the response and remain committed to applying our strengths where they make a meaningful difference for communities in need while creating value for our shareholders. In International Diagnostics, our Q2 progress reflects an approach to stabilize, diversify, and localize. We continue to serve long standing HIV testing customers while also expanding the portfolio and deepening relationships with partners that support public health needs from Africa to Latin America and in between and beyond. While Ebola is our latest example of the strength of our capabilities to serve global markets, Another is our work on nearshoring, an in-country value-added assembly program for our OraQuick HIV self-test. Which we discussed in Q1. These partnerships are increasingly important as national health programs adapt to evolving funding structures, and as customers seek more resilient local supply chains. We expect to share more on localization later this year. A third strong global example is in the progress following our acquisition of BioMedomics, with SickleSCAN. We are seeing encouraging progress integrating SickleSCAN into our international commercial channel and pursuing opportunities with national health programs in geographies where point-of-need sickle cell testing can address significant unmet need. In the hands of our international sales team, SickleSCAN revenue is growing 2x as fast in 2026 as it did in 2025. Taken together, Ebola 2.0 rapid test access, OraQuick HIV nearshoring, and SickleSCAN expansion reflects a strategic evolution of our international diagnostics business. By addressing critical public health priorities, with increasing localization, while diversifying our revenue base, we are creating new avenues for growth and reinforcing the capabilities that differentiate OTI globally. We believe this approach positions us to serve customers more effectively strengthen long term partnerships, and create durable value for shareholders. Switching to US diagnostics. We saw stronger public health demand in Q2, including customer purchasing patterns tied to fiscal-year cycle. Even with continued federal funding pressure, HIV testing programs remain an important public health priority, and demand for our market leading OraQuick HIV Self Test was strong in the quarter. We also continue to benefit from the syndemic testing approach we have discussed on prior calls. By offering rapid tests across HIV, HCV, and syphilis, we can help customers address overlapping populations while delivering both clinical and health economic value. In addition, our consumer and B2B2C channels for the OraQuick HIV Self-Test continue to grow including through telehealth and other digital access points. These channels provide a strong foundation for future OTC and decentralized STI testing opportunities, and reinforce the growing demand for convenience, private access to diagnostic testing. That demand is also reflected in the opportunity we see for IntelliQ CT/NG molecular self-testing. As I mentioned earlier, I want to provide more detail on the withdrawal of our FDA submission and our regulatory path forward. Our studies demonstrated strong performance compared with centralized laboratory molecular diagnostic methods. And we remain encouraged by the product's performance and its potential to address an important public health need. Based on the strength of our data, across all elements of performance, the demonstrated patient and provider need for this test and the value of IntelliQuick's differentiated profile. We had anticipated FDA clearance around this time. Following constructive interactions with the FDA, and in consultation with them, we are building our plan for resubmission. While we are disappointed by the delay in obtaining regulatory clearance and broader market access for IntelliQ CT/NG our confidence in the quality, performance, and clinical value of the test has only increased. We will provide additional updates on our progress in future quarters as we move quickly to complete the work we think is needed for regulatory clearance and full market launch. Moving to sample management solutions. We are seeing various levels of improvement across key customer segments, including commercial, advanced diagnostic testing laboratories, and other precision health care applications. Including microbiome collection, along with early signs of recovery in academic and research channels. We are encouraged by increasing utilization of genetic insight to assess disease risk inform diagnoses, and guide patient care. For example, The UK's National Institute for Health and Care Excellence also known as NICE, Its recent draft guidance recommending Ziwig Endotest marks another important commercial validation of saliva based diagnostics in women's health and expands access to noninvasive testing for endometriosis within The UK health care system. 've talked about Ziwig before, and EndoTest incorporates DNA Genotek's OMNIgene•ORAL saliva collection, and nucleic acid stabilization technology, underscoring the capability of our collection solutions to support advanced testing. This adoption demonstrates the versatility of our technology beyond genetics, into high value diagnostic applications and it reinforces our position as a trusted partner for innovative developers. As demand grows for similar accessible, patient friendly testing, we believe our broad portfolio of collection technologies are well positioned to support the next generation of women's health, wellness, and molecular diagnostic programs worldwide. Additionally, in SMS innovation, we were excited in Q2 to announce the important milestone we achieved with Dx urine collection kit receiving FDA clearance. The kit solution comprises the Colli-Pee Dx collection device, which enables volumetric self collection of biomarker rich urine. Enabling a broad range of testing solutions. And our NUCLEO-PRECISION chemistry, which is proprietary and nontoxic, for the stabilization and storage of biomarkers. The reason FDA clearance applies to 8 STI indications, that is 4 types of Roche cobas tests chlamydia, gonorrhea, trich, and nGen, for both male and female self collected urine on the Roche cobots molecular diagnostic platform. The Colli-Pee launch is off on nice start as customers are expressing strong interest in the innovation and its potential to expand access to STI testing, that is more convenient and private. Overall, SMS revenue increased sequentially in Q2. Combined with the anticipated contribution from Colli-Pee and its nuclear precision chemistry, we remain confident in the long term outlook for sample management solutions and its ability to help drive growth in 2026 and beyond. With that, I will turn the call over to Kenneth to discuss our financial results and guidance. Kenneth J. McGrath: Thanks, Carrie. Total revenue in the second quarter was $30.6 million and grew 9.7% on a sequential basis. Diagnostic products generated $19.4 million of revenue in Q2, with U. S. Revenue higher than international revenue. Diagnostics revenue grew 14.7% on a sequential basis. Reflecting stronger public health demand including customer purchasing tied to fiscal-year cycles. As well as higher syphilis revenue and the addition of BioMedomics SickleSCAN sales. Sample Management Solutions revenue in Q2 was $9.9 million and grew 9% on a sequential basis with growth across segments. Our Q2 GAAP gross margin increased 120 basis points sequentially to 43.5% from 42.3% in Q1 2026. And non GAAP gross margin in Q2 increased to 44.2% compared to 43.4%. Gross margin expansion was driven by lower scrap and operational efficiencies, partially offset by revenue mix. Looking at GAAP operating expense in Q2, R&D expense was $9.4 million sales and marketing expense was $6.6 million and general and administrative expense was $14.4 million. R&D expense declined both sequentially and year over year reflecting the tapering of launch preparation and production readiness spending for our Colli-Pee device. The year over year increase in G&A was primarily driven by nonrecurring items. Including higher legal and professional service costs related to our proxy and stockholder activism. As we stated last call, we expect G&A expense to decline to more normalized levels beginning in Q3 as these nonrecurring items wind down. Included in the Q2 financials the company recorded a reduction in its contingent consideration liability as a result of updating our submission plan to incorporate feedback from the FDA for the CT/NG test on the SHERLOC platform. Non cash stock compensation expense in the second quarter was $2.3 million and depreciation and amortization expense was $2.4 million and our GAAP operating income in Q2 was $5.4 million and our non GAAP operating loss was $14.7 million. Moving to our balance sheet. We ended the quarter with zero debt and total cash and cash equivalents of $161 million. During the second quarter, we deployed $2 million to repurchase 647 thousand shares of common stock. Since initiating the program last year, we have returned $22 million to shareholders through the repurchase of 7.7 million shares. Representing nearly 10% of our outstanding shares. And utilizing approximately 55% of the $40 million authorization. Given the commercial opportunities ahead, we paused additional repurchase activity during the quarter, and are prioritizing balance sheet flexibility to support launch related investment across the portfolio. Including Colli-Pee, and Ebola 2.0 rapid test. The authorization remains in place, and we will continue to evaluate repurchase over time. Consistent with our balanced capital deployment strategy, we continue to evaluate organic and inorganic opportunities that can accelerate our profitable growth in high value markets, leverage our existing capabilities. Operating cash flow in the second quarter was negative $9.9 million, which was consistent with our expectations. As Carrie stated, we expect to return to breakeven and cash flow from operations entering 2027. This view is supported by our outlook for revenue growth including anticipated contributions from new product launches as well as our continued focus on cost savings and operating efficiencies. Moving to guidance. We expect revenue in the third quarter of $29.5 million to $32.5 million And we expect our gross margin in Q3 to be similar to Q2. With that, I will turn the call back to Carrie to conclude. Carrie Eglinton Manner: Thanks, Ken. As we enter the second half of 2026, OraSure is a more focused and operationally disciplined company with a stronger innovation pipeline. We simplified the portfolio strengthened our production capabilities, and consolidated our manufacturing footprint We advanced important technology and product milestones while also a return to growth and preparing for revenue contributions from the launches of Colli-Pee and our Ebola 2.0 rapid test. These achievements reflect the discipline of our operating model, the strength of our innovation engine, the differentiation of our products, and the commercial value and execution of our decentralized diagnostic strategy. Looking ahead, we remain focused on converting our pipeline into growth, expanding our portfolio across attractive markets and leveraging our manufacturing capabilities and global partner relationships. Together, these drivers position Orasure to deliver sustainable, long term value for our customers, partners and shareholders. Thank you for your continued support and confidence in OTI. We look forward to updating you on our progress next quarter. With that, I am pleased to turn the call over to the operator. Operator: Thank you. Thanks. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again. Our first question comes from the line of Mac Etoch of Stephens. Your line is now open. Analyst: Hey. Good afternoon. Maybe just a couple of questions for me. Just given the CT/NG update, I would love to get a sense of how you are thinking about the timing around a resubmission and then potential approval past that? And then secondly, how is that affecting your cost structure moving forward? I know there is some lingering costs around post approval studies that were going on as well. Thanks. Carrie Eglinton Manner: Yeah. Thanks. Thanks, Mac. You know, I will just start with our confidence in the IntelliQ test and the performance that it demonstrated. You while we are working to incorporate FDA feedback, we plan to resubmit it. This is a recent discussion And in terms of timing, we plan to come back to share more on that. You know, we are we are obviously moving quickly in collaboration with them. This is a-- this is a priority. But we will we will update you. We will update our investors with more on timing as we have that. Kenneth J. McGrath: Yeah. And Mac, as far as the cost, this will not this will not incrementally add to our overall cash flow from operations usage. there is an offset here related to the milestone payments that will that will be reduced And, obviously, you can imagine as we go forward, with our plan, there will be some dollars, incremental dollars to support that. But that will be lower than the expected reduction in milestones. Carrie Eglinton Manner: So in terms of how we think about the total year, Mac, we are clearly disappointed in that delayed timing. Obviously, we were working hard toward a-- to work toward clearance and launch But in terms of our exit expectations for the year, I want to reiterate, it does not change our outlook on growth for the year, and it, in an unanticipated way, we expect that to cost less. We had every intention of that clearance. We believe it is a matter of timing. And this is all about working towards the resubmission. Analyst: Got it. And maybe just to clarify on that point, Kenneth, it sounds like maybe any incremental cost that might be incurred from whatever it might be will be offset by a reduced like, a reduction of that $20 million contingency payment? Kenneth J. McGrath: Correct. Analyst: Awesome. Thank you. And then maybe in terms of SMS, I think I heard in my connection's a little spotty today, but can you can you speak to what you are seeing in terms of the advanced genetic testing lab demand? Carrie Eglinton Manner: Yes. So we are seeing the sort of continued not only green shoots in other labs that are growing, but we are seeing a fairly consistent recovery amongst kind of the advanced genetic labs more broadly. So, you know, we delivered that sequential growth. You I would say this has remained muted post COVID. But there is progress, and we see not only advanced genetic testing labs, we see areas like microbiome collection that had been somewhat soft In the last couple of years, we see-- have seen some uptick there as well. Got it. Thank you. I will jump back in the queue. Great. Operator: Thank you. I am showing no further questions at this time. I would like to turn it back to Carrie Eglinton Manner for closing remarks. Carrie Eglinton Manner: Great. Thank you to all of you for your engagement and support. Ari, thank you for the facilitation. We look forward to providing updates in the next quarter. With that, we will close the call. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in OraSure Technologies, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and OraSure Technologies wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* Now, it’s worth noting Stock Advisor’s total average return is 958% — a market-crushing outperformance compared to 214% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 12, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. OraSure (OSUR) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Interested in OraSure Technologies, Inc.? Here are five stocks we like better. Q2 revenue rose 9.7% sequentially to $30.6 million, exceeding guidance, as diagnostic-products revenue increased 14.7% and sample-management revenue grew 9%. Stronger public-health demand, syphilis testing, Sickle SCAN and laboratory recovery supported the results. OraSure achieved key regulatory milestones with FDA clearance for its Colli-Pee Dx STI urine-collection kit and Emergency Use Authorization for the OraQuick Ebola 2.0 test. However, the company delayed its expected 2026 U.S. launch of the IntelliQuick CT/NG test and plans to revise and resubmit its application. Gross margin improved to 43.5%, while the company ended the quarter debt-free with $161 million in cash. Management expects third-quarter revenue of $29.5 million to $32.5 million and continues targeting operating cash-flow break-even as it enters 2027. Is Co-Diagnostics National Security’s Next Diagnostic Pick? OraSure Technologies (NASDAQ:OSUR) reported second-quarter revenue of $30.6 million, exceeding its guidance range and rising 9.7% sequentially, as stronger public-health diagnostics demand and growth in sample-management products supported results. President and Chief Executive Officer Carrie Eglinton Manner said the quarter marked continued progress in the company’s transformation, citing sequential gross-margin improvement, new regulatory milestones and efforts to position the business for growth in the second half of 2026 and beyond. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control “Q2 demonstrated that transition beginning to take shape through stronger revenue, improving margins, and meaningful innovation milestones,” Eglinton Manner said. Diagnostic-products revenue totaled $19.4 million, increasing 14.7% from the prior quarter. Chief Financial Officer Ken McGrath said U.S. diagnostics revenue exceeded international revenue during the period. The sequential gain reflected stronger public-health demand, including customer purchasing associated with fiscal-year cycles, higher syphilis-test revenue and contributions from BioMedomics’ Sickle SCAN product. → 3 Drone Stocks That Should Soar After the Summer Slump The company said demand for its OraQuick HIV Self-Test was strong in U.S. public-health programs despite ongoing federal funding pressure. OraSure also cited growth in consumer and business-to-business-to-consumer channels, including telehealth and digital-access outlets. Internationally, OraSure said it is seeking to diversify and localize its diagnostics business. The company continues to support long-standing HIV testing customers while pursuing nearshoring and in-country value-added assembly programs for OraQuick HIV Self-Test products. Eglinton Manner said the company expects to provide additional details on localization initiatives later this year. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Sickle SCAN revenue is growing at twice the rate in 2026 as it did in 2025, according to Eglinton Manner, as OraSure integrates the product into its international commercial channels and pursues national health-program opportunities. Sample Management Solutions revenue was $9.9 million, up 9% sequentially, with growth across segments. OraSure said it saw improving demand among commercial and advanced diagnostic-testing laboratories, microbiome-collection applications and early signs of recovery in academic and research markets. During the question-and-answer session, Eglinton Manner said the company is seeing a “fairly consistent recovery” among advanced genetic-testing laboratories, while noting that the segment has remained muted since the COVID period. In June, OraSure received FDA clearance for its Colli-Pee Dx urine collection kit, which enables at-home self-collection of volumetric first-void urine samples for sexually transmitted infection testing. The clearance covers use of the collection device and its NucleoPrecision technology with Roche cobas tests for chlamydia, gonorrhea, trichomoniasis and M. genitalium in male and female self-collected urine samples. The company said the Colli-Pee Dx launch has started positively, with customers expressing interest in its potential to make STI testing more convenient and private. OraSure also received FDA Emergency Use Authorization for its second-generation OraQuick Ebola 2.0 Rapid Antigen Test. The test detects all four Ebola virus species known to cause human disease, including the Bundibugyo species associated with the current outbreak in Central Africa, according to the company. However, the company said it no longer expects FDA clearance and a U.S. launch for its IntelliQuick CT/NG test on the Sherlock platform during 2026. OraSure withdrew its FDA submission after constructive discussions with the agency and plans to incorporate FDA feedback before resubmitting. Eglinton Manner said the company remains confident in the rapid molecular self-test’s performance and clinical value but did not provide a timetable for resubmission or potential clearance. “This is a recent discussion, and in terms of timing, we plan to come back to share more on that,” she said. McGrath said costs associated with the resubmission effort are not expected to increase the company’s overall operating cash-flow usage. He said incremental spending would be more than offset by a reduction in expected milestone payments, confirming an analyst’s reference to a $20 million contingent payment. GAAP gross margin increased 120 basis points sequentially to 43.5% from 42.3% in the first quarter. Non-GAAP gross margin rose to 44.2% from 43.4%. McGrath attributed the gains to lower scrap and operational efficiencies, partly offset by revenue mix. Second-quarter GAAP operating income was $5.4 million, while non-GAAP operating loss was $14.7 million. OraSure recorded a reduction in its contingent-consideration liability after updating its CT/NG submission plan. The company ended the quarter with no debt and $161 million in cash and cash equivalents. Operating cash flow was negative $9.9 million in the quarter. Management reiterated its expectation to reach break-even cash flow from operations as it enters 2027, supported by anticipated revenue growth, new product launches, cost savings and operating efficiencies. OraSure repurchased 647,000 shares for $2 million during the second quarter. Since beginning its repurchase program last year, the company has spent $22 million to buy back 7.7 million shares, representing nearly 10% of outstanding shares. The company paused further repurchases during the quarter to preserve flexibility for launch-related investments, including Colli-Pee and Ebola 2.0. For the third quarter, OraSure projected revenue of $29.5 million to $32.5 million and said gross margin is expected to be similar to the second quarter. OraSure Technologies, Inc is a Bethlehem, Pennsylvania–based diagnostic and medical device company specializing in the development, manufacture and commercialization of point-of-care and self-testing products. Founded in 1988, OraSure has built a portfolio of oral fluid and other non-invasive specimen collection technologies that support the detection of infectious diseases, drugs of abuse, and health and wellness biomarkers. The company's flagship product, the OraQuick® rapid HIV test, was the first Food and Drug Administration–approved over-the-counter oral fluid test for the detection of HIV-1/2 antibodies. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "OraSure Technologies Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Total Revenue: $30.6 million in Q2 2026, exceeding guidance and growing 9.7% sequentially. Diagnostic Products Revenue: $19.4 million in Q2, up 14.7% sequentially, driven by stronger public health demand and higher syphilis revenue. Sample Management Solutions Revenue: $9.9 million in Q2, up 9% sequentially, with growth across segments. GAAP Gross Margin: 43.5% in Q2, up 120 basis points sequentially from 42.3% in Q1 2026. Non-GAAP Gross Margin: 44.2% in Q2, up from 43.4% in Q1. R&D Expense: $9.4 million in Q2, declining sequentially and year over year. Sales and Marketing Expense: $6.6 million in Q2. General and Administrative Expense: $14.4 million in Q2, with year-over-year increase driven by non-recurring items. GAAP Operating Income: $5.4 million in Q2. Non-GAAP Operating Loss: $14.7 million in Q2. Operating Cash Flow: $9.9 million in Q2, consistent with expectations. Cash Position: Zero debt and $161 million in total cash and cash equivalents at quarter end. Share Repurchases: $2 million deployed in Q2 to repurchase 647,000 shares; $22 million returned to shareholders since program initiation. Q3 2026 Revenue Guidance: Expected between $29.5 million and $32.5 million. Q3 2026 Gross Margin Guidance: Expected to be similar to Q2 levels. Warning! GuruFocus has detected 6 Warning Signs with OSUR. Is OSUR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OraSure Technologies Inc (NASDAQ:OSUR) exceeded its Q2 2026 revenue guidance, with total revenue of $30.6 million, growing 9.7% sequentially. Gross margins expanded sequentially, with GAAP gross margin up 120 basis points to 43.5% and non-GAAP gross margin up to 44.2%, driven by lower scrap and operational efficiencies. The company achieved significant regulatory milestones, including FDA clearance for the Colli-Pee Dx urine collection kit and FDA Emergency Use Authorization for the OraQuick Ebola 2.0 Rapid Test. Sickle SCAN revenue is growing twice as fast in 2026 compared to 2025, reflecting successful integration into international commercial channels. The company maintains a strong balance sheet with zero debt and $161 million in cash, and has returned $22 million to shareholders through share repurchases, representing nearly 10% of outstanding shares. Sample Management Solutions revenue grew 9% sequentially, with growth across segments and early signs of recovery in academic and research channels. OraSure Technologies Inc (NASDAQ:OSUR) withdrew its FDA submission for the InteliQuick CT/NG test, delaying expected clearance and US launch beyond 2026. The company recorded a reduction in its contingent consideration liability due to the updated submission plan for the CT/NG test, indicating a delay in milestone payments. G&A expenses increased year-over-year due to non-recurring items, including higher legal and professional service costs related to proxy and stockholder activism. The company paused additional share repurchase activity during the quarter to prioritize balance sheet flexibility for launch-related investments. Despite progress, the company still reported a non-GAAP operating loss of $14.7 million in Q2, indicating ongoing profitability challenges. The delay in InteliQuick CT/NG clearance could impact future revenue growth expectations, although the company maintains its 2026 growth outlook. Q: Given the CT/NG update, how are you thinking about the timing around a resubmission and potential approval? And how is this affecting your cost structure moving forward?A: Carrie Eglinton Manner (CEO) stated that while the company remains confident in the InteliQuick test's performance, they are incorporating FDA feedback and plan to resubmit. They are moving quickly in collaboration with the agency and will provide investors with more timing details as they become available. Ken McGrath (CFO) added that this will not incrementally add to overall cash flow from operations usage, as incremental costs to support the resubmission will be offset by a reduction in milestone payments. Q: Can you clarify if the incremental costs from the CT/NG resubmission will be offset by a reduction in the $20 million contingency payment?A: Ken McGrath (CFO) confirmed that this is correct. The incremental dollars needed to support the resubmission plan will be lower than the expected reduction in milestone payments, thereby neutralizing the impact on cash flow. Q: Can you speak to what you're seeing in terms of advanced genetic testing lab demand within the Sample Management Solutions (SMS) segment?A: Carrie Eglinton Manner (CEO) noted that while the segment has remained muted post-COVID, they are seeing a fairly consistent recovery among advanced genetic labs more broadly, which contributed to sequential growth. She also highlighted an uptick in areas like microbiome collection, which had been somewhat soft in the last couple of years. Q: What were the key drivers behind the sequential revenue growth and gross margin expansion in Q2 2026?A: Ken McGrath (CFO) reported that total revenue grew 9.7% sequentially to $30.6 million, driven by a 14.7% increase in diagnostic revenue (from stronger public health demand, higher syphilis revenue, and Sickle SCAN sales) and a 9% increase in SMS revenue. GAAP gross margin expanded 120 basis points sequentially to 43.5%, driven by lower scrap and operational efficiencies, partially offset by revenue mix. Q: What is the company's outlook for Q3 2026 revenue and gross margin?A: Ken McGrath (CFO) provided guidance for Q3 revenue in the range of $29.5 million to $32.5 million. He also stated that the company expects Q3 gross margin to be similar to Q2's level of 43.5% (GAAP) and 44.2% (non-GAAP). Q: Can you provide an update on the FDA clearance for the Colli-Pee Dx urine collection kit and its commercial launch?A: Carrie Eglinton Manner (CEO) highlighted the FDA clearance announced in mid-June for the Colli-Pee Dx kit, which enables at-home self-collection of volumetric first void urine samples for STI testing. The clearance applies to eight STI indications on Roche's cobas molecular diagnostic platform. She noted that the launch is off to a nice start, with customers expressing strong interest in the innovation's potential to expand access to more convenient and private STI testing. Q: What is the significance of the FDA Emergency Use Authorization (EUA) for the OraQuick Ebola 2.0 Rapid Test?A: Carrie Eglinton Manner (CEO) explained that the EUA for the second-generation test, developed in partnership with BARDA, detects all four Ebola virus species known to cause human disease, including the Bundibugyo species driving the current outbreak in Central Africa. This authorization underscores OraSure's strengths in public health, including R&D expertise, regulatory capabilities, manufacturing scale, and global partnerships, enabling rapid response to emerging health threats. Q: How is the company progressing with its international diagnostics strategy, particularly regarding localization and portfolio diversification?A: Carrie Eglinton Manner (CEO) discussed progress on near-shoring and in-country value-added assembly programs for the OraQuick HIV self-test, which are becoming increasingly important as customers seek resilient local supply chains. She also highlighted the integration of Sickle SCAN, acquired from BioMedomics, noting that its revenue is growing twice as fast in 2026 as it did in 2025, driven by opportunities with National Health Programs in geographies with significant unmet need. Q: Can you elaborate on the company's capital deployment strategy, including the pause in share repurchases?A: Ken McGrath (CFO) stated that the company paused additional repurchase activity during Q2 to prioritize balance sheet flexibility for launch-related investments across the portfolio, including Colli-Pee and Ebola 2.0. The $40 million authorization remains in place, and they will continue to evaluate repurchases over time. He also noted that the company continues to evaluate organic and inorganic opportunities to accelerate profitable growth. Q: What gives management confidence in achieving operating cash flow breakeven entering 2027, despite the InteliQuick delay?A: Carrie Eglinton Manner (CEO) reiterated that the InteliQuick delay does not change their commitment or ability to deliver on revenue growth in 2026 or cash flow from operations breakeven as they enter 2027. Ken McGrath (CFO) added that this view is supported by their outlook for revenue growth, including anticipated contributions from new product launches, as well as their continued focus on cost savings and operating efficiencies. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterizes 2026 as a transition year, shifting from restructuring and portfolio simplification to execution against a focused growth strategy. Sequential revenue growth of 9.7% was driven by stronger public health demand in U.S. diagnostics and a recovery across key sample management segments. Gross margin expansion to 43.5% resulted from operational efficiencies and insourcing manufacturing to Pennsylvania facilities, partially offset by revenue mix. The International Diagnostics segment is pivoting toward a 'localize' strategy, utilizing nearshoring and in-country assembly to meet evolving national health funding structures. The acquisition of BioMedomics is showing early success, with SickleSCAN revenue growing twice as fast in 2026 compared to the prior year. Management withdrew the FDA submission for the IntelliQ CT/NG rapid molecular test to incorporate agency feedback, despite maintaining high confidence in the test's clinical performance. The company is leveraging a 'syndemic' testing approach, bundling HIV, HCV, and syphilis tests to address overlapping patient populations and deliver higher health economic value. Management reiterated its commitment to achieving operating cash flow breakeven as the company enters 2027, supported by new product contributions and cost discipline. The delay of the IntelliQ CT/NG launch is not expected to change the company's ability to deliver overall revenue growth for the full year 2026. Q3 2026 revenue is projected between $29.5 million and $32.5 million, with gross margins expected to remain stable relative to Q2 levels. Future growth is contingent on the successful commercial launch of the Colli-Pee collection kit and the second-generation OraQuick Ebola rapid test. The company has paused share repurchases to prioritize balance sheet flexibility for launch-related investments and potential inorganic growth opportunities. A reduction in contingent consideration liability was recorded following the updated submission plan for the CT/NG test, providing a non-cash benefit to GAAP operating income. G&A expenses were elevated in Q2 due to non-recurring legal and professional fees related to stockholder activism, with a return to normalized levels expected in Q3. The FDA emergency use authorization for the OraQuick Ebola 2.0 test allows the company to address the current outbreak in Central Africa while diversifying the international portfolio. The Colli-Pee urine collection kit received FDA clearance for eight STI indications, marking a significant milestone for the Sample Management Solutions segment. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management declined to provide a specific timeline for resubmission, stating they are currently incorporating FDA feedback as a high priority. The delay will not negatively impact cash flow targets because the reduction in milestone payments (contingent consideration) will more than offset incremental R&D costs. The company expects the total cost of the project to be lower than originally anticipated due to the reduced milestone obligations. Management noted 'green shoots' and a consistent recovery in advanced genetic labs, which had remained muted since the pandemic. There is a observed uptick in microbiome collection demand after several years of softness, contributing to the 9% sequential growth in Sample Management Solutions.

BETHLEHEM, Pa., Aug. 05, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended June 30, 2026. “Our Q2 results demonstrate continued progress in our return-to-growth trajectory, with revenue of $30.6 million, up 9.7% sequentially and above our guidance range, along with solid gross margin improvement,” said Carrie Eglinton Manner, President and CEO of OTI. “We also advanced key innovation milestones, including recent FDA clearance of our Colli-Pee™•Dx at-home urine collection device for sexually transmitted infections, and FDA Emergency Use Authorization of our OraQuick™ Ebola 2.0 Rapid Antigen Test.” “These achievements reflect our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private,” she continued. “Supported by a strong balance sheet, we have the flexibility and capacity to pursue targeted growth initiatives by investing in innovation and bringing it to scale while maintaining the potential to strengthen our portfolio through strategic collaborations and acquisitions." Financial Highlights ($ in 000’s, except per share amounts) (1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues. NM – not meaningful For additional information on non-GAAP financial measures and a reconciliation of the GAAP financial results to non-GAAP financial results, see the schedules below. A description of the adjustments made to the GAAP financial measures is included at the end of the schedules. Total net revenues for the second quarter of 2026 of $30.6 million grew 10% sequentially and decreased 2% year over year. Core revenues (all revenues excluding COVID-19 and Risk Assessment Testing revenues) of $30.6 million in the second quarter of 2026 remained largely flat year-over-year. Diagnostics revenues in the second quarter of 2026 increased 1% year-over-year to $19.4 million, with the increase attributable to higher syphilis revenues and the addition of BioMedomics’ Sickle SCAN™ sales. Sample Management Solutions revenues of $9.9 million in the second quarter of 2026 were flat year-over-year. GAAP gross margin was 43.5% in the second quarter of 2026 compared to 42.1% in the second quarter of 2025. Non-GAAP gross margin in the second quarter of 2026 was 44.2% and increased compared to 43.2% in the second quarter of 2025. GAAP operating income in the second quarter of 2026 was $5.4 million compared to GAAP operating loss of $18.0 million in the second quarter of 2025. Non-GAAP operating loss was $14.7 million in the second quarter of 2026 compared to non-GAAP operating loss of $13.2 million in the second quarter of 2025. During the second quarter of 2026 the company recorded a $22.6 million reduction in its contingent consideration liability as a result of updating our submission plan to incorporate feedback from the FDA for the CT/NG test on the Sherlock platform. GAAP net income in the second quarter of 2026 was $6.2 million compared to a GAAP net loss of $19.7 million in the second quarter of 2025. Non-GAAP net loss was $13.8 million in the second quarter of 2026 compared to non-GAAP net loss of $14.2 million in the second quarter of 2025. Cash and cash equivalents were $161 million as of June 30, 2026. During the second quarter of 2026, the Company repurchased approximately $2 million of common stock, bringing total repurchases to approximately $22 million, or 7.7 million shares, of our $40 million authorization. Repurchases to date represent over 10% of outstanding, shares. Recent Developments In June 2026, we received FDA clearance of our Colli-Pee™•Dx Urine Collection Kit for use with Roche’s STI tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG). The FDA-cleared collection kit enables convenient at-home self-collection of first-void urine by both male and female patients. Specimens can be collected at any time of day in the privacy of the home or any other private setting and are intended for testing on the Roche cobas molecular diagnostics platform. In July 2026, we received Emergency Use Authorization from the FDA for our second generation OraQuick™ Ebola 2.0 Rapid Antigen Test for use with whole blood in live patients, as well as cadaveric oral fluid for individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest. We are updating our submission plan for our InteliQuick™ CT/NG molecular self-test on the Sherlock platform to incorporate feedback received through constructive interactions with the FDA. As part of this process, in July 2026 we elected to withdraw the current submission and plan to pursue a future submission. Our InteliQuick™ CT/NG studies demonstrated strong performance compared with centralized laboratory molecular diagnostic methods, and we remain encouraged by the product’s performance, its differentiated profile, and its potential to serve a significant public health need. Financial Guidance The Company is guiding to Q3 2026 total revenues of $29.5 million to $32.5 million. Conference Call The Company will host a conference call and audio webcast to discuss the Company’s second quarter 2026 results and certain business developments, beginning today at 5 p.m. Eastern Time. The call will include prepared remarks by management and a question and answer session. A webcast of the conference call will be available on the investor relations page of OTI’s website at https://orasure.gcs-web.com/events-and-presentations. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes prior to the call. The webcast will be archived on OTI’s website shortly after the call has ended. Disclosure OTI intends to use the Investor Relations Section of its website as a means of disclosing material non-public information (MNPI) and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor OTI’s website in addition to following its press releases, SEC filings, public conference calls, presentations, and webcasts. Financial Data (Unaudited, $ in 000’s, except per share amounts) Condensed Consolidated Balance Sheets (Unaudited, $ in 000’s) Additional Financial Data (Unaudited, $ in 000’s) Consolidated Statement of Cash Flows (Unaudited, $ in 000’s) About OraSure Technologies OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the federal securities laws. These may include statements about the Company's expected revenues, earnings/losses per share, net income (loss), expenses, cash flow or other financial performance, or developments, clinical trial or development activities, expected regulatory filings and approvals, planned business transactions, views of future industry, competitive or market conditions, and other factors that could affect the Company's future operations, results of operations or financial position. These statements often include words, such as “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates,” “may,” “will,” “should,” “could,” or similar expressions. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: market acceptance of, and our ability to develop, commercialize, market and sell our products and services, whether through our internal, direct sales force, distributors or third parties; our ability to obtain and comply with necessary regulatory approvals for new products or new indications or applications for existing products, including timing and associated costs; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; significant customer concentrations that exist or may develop in the future; our ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; changes in relationships with strategic partners or other parties, including disputes or disagreements, and reliance on such parties for the performance of critical activities under collaborative arrangements; our ability to meet increased demand for our products; the impact of replacing distributors; our ability to achieve our financial and strategic objectives, including increasing our revenues and gross margins, and our ability to expand international sales; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; changes in market acceptance of our products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; our ability to fund research and development and other products and operations; availability of raw materials and our reliance on sole supply sources for critical products and components; impact of contracting with the U.S. government; estimates regarding revenues, expenses, capital requirements and needs for additional financing; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection, potential patent infringement claims, the availability of licenses to patents or other technology and costs of litigation relating to intellectual property, product liability and other types of litigation; the impact of changes in international funding sources and testing algorithms on international sales; adverse movements in foreign currency exchange rates; our ability to attract and retain qualified personnel; changes in international, federal or state laws and regulations; and the impact of geopolitical and economic conditions on the Company’s business. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements. Statement Regarding Use of Non-GAAP Financial Measures In this press release, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures, including non-GAAP gross margin, non-GAAP gross profit, non-GAAP cost of good sold, non-GAAP net income (loss), non-GAAP operating income (loss), and non-GAAP earnings (loss) per share. Management believes that presentation of operating results using these non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods, while excluding certain expenses that may not be indicative of the Company’s recurring core business operating results. In addition, management believes these non-GAAP financial measures are useful to investors both because they (1) allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) are used by OraSure’s institutional investors and the analysis community to help them analyze the health of OraSure’s business. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the schedules below and a description of the adjustments made to the GAAP financial measures is included at the end of the schedules. The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's, except per share amounts) The following is a description of the adjustments made to GAAP financial measures: Stock Compensation: non-cash equity-based compensation provided to OraSure employees and directors Amortization of acquisition-related intangible assets: represents recurring amortization charges resulting from the acquisition of intangible assets associated with our business combinations Inventory reserve for product line discontinuance: represents inventory associated with discontinued line of business Reduction in workforce severance: termination benefits associated with the Company’s workforce reduction associated with certain business Executive severance expense: expenses associated with the departure of an executive Gain on sale of assets under product line discontinuance: represents the gain on the sale of fixed assets associated with the risk assessment line of business that was discontinued and sold to a third party Change in fair value of acquisition-related contingent consideration: changes in the fair value of contingent consideration liability associated with changes in the probability of milestone payments and the impact of the passage of time and updated forecasts. Loss on equity investment: we have excluded our proportionate share of our equity method investee’s net loss as we do not have direct control over the investee’s operations or resulting revenue and expenses Tax impact associated with non-GAAP adjustments: tax expense/(benefit) due to non-GAAP adjustments A reconciliation of our non-GAAP measures to their most directly comparable GAAP measures can also be found at: https://orasure.gcs-web.com/gaap-non-gaap-reconciliation

BETHLEHEM, Pa., May 06, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended March 31, 2026. “Our Q1 results were consistent with our expectations, and revenue of $27.9 million was above the midpoint of our guidance range,” said Carrie Eglinton Manner, President and CEO of OTI. “We delivered gross margin expansion in Q1 and remain focused on leveraging our manufacturing capabilities and capacity to drive additional operating efficiencies.” She continued, “OraSure is well positioned to accelerate our growth as we approach a series of regulatory and commercial milestones in 2026 and continue to transform our business through our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. Additionally, our strong balance sheet gives us the flexibility to pursue acquisitions and partnerships that strengthen our portfolio, while continuing to invest in R&D aimed at high‑value growth markets in order to drive long‑term value for shareholders.” Financial Highlights ($ in 000’s, except per share amounts) (1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues. NM – not meaningful Total net revenues for the first quarter of 2026 decreased 7% to $27.9 million from $29.9 million in the first quarter of 2025. Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $27.9 million in the first quarter decreased 0.5% year-over-year. Diagnostics revenues in the first quarter decreased 5% year-over-year to $16.9 million, with the decline attributable to lower revenue from our HCV tests. Sample Management Solutions revenues of $9.1 million in the first quarter decreased 0.6% year-over-year. GAAP gross margin was 42.3% in the first quarter of 2026 compared to 41.1% in the first quarter of 2025. Non-GAAP gross margin in the first quarter of 2026 was 43.4% and increased compared to 41.7% in the first quarter of 20251. GAAP operating loss in the first quarter of 2026 was $23.3 million compared to GAAP operating loss of $17.8 million in the first quarter of 2025. Non-GAAP operating loss was $19.0 million in the first quarter of 2026 compared to non-GAAP operating loss of $15.3 million in the first quarter of 2025. Cash and cash equivalents were $177 million as of March 31, 2026. OTI deployed $5 million during the first quarter to repurchase approximately 1.8 million shares of our common stock. ____________________________ 1 For additional information on non-GAAP financial measures and a reconciliation of the GAAP financial results to non-GAAP financial results, see the schedules below. A description of the adjustments made to the GAAP financial measures is included at the end of the schedules. Recent Developments Appointed John D. Bertrand to our Board of Directors. Mr. Bertrand is a healthcare technology executive with more than a decade of experience driving AI-enabled innovation in diagnostics. Published our 2025-2026 “OTI Cares” Impact and Governance report, which highlights our progress in advancing the impact of our sustainability and governance-related initiatives that are meaningful to our internal and external stakeholders. Financial Guidance The Company is guiding to Q2 2026 Total revenues of $27 million to $30 million. Conference Call The Company will host a conference call and audio webcast to discuss the Company’s first quarter 2026 results and certain business developments, beginning today at 5 p.m. Eastern Time. The call will include prepared remarks by management and a question and answer session. A webcast of the conference call will be available on the investor relations page of OTI’s website at https://orasure.gcs-web.com/events-and-presentations. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes prior to the call. The webcast will be archived on OTI’s website shortly after the call has ended. Disclosure OTI intends to use the Investor Relations Section of its website as a means of disclosing material non-public information (MNPI) and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor OTI’s website in addition to following its press releases, SEC filings, public conference calls, presentations, and webcasts. Financial Data (Unaudited, $ in 000’s, except per share amounts) Condensed Consolidated Balance Sheets (Unaudited, $ in 000’s) Additional Financial Data (Unaudited, $ in 000’s) Consolidated Statement of Cash Flows (Unaudited, $ in 000’s) About OraSure Technologies OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com Forward Looking Statements This press release contains certain forward-looking statements, including with respect to products, product candidate development and manufacturing activities, regulatory submissions and authorizations, revenue growth and guidance, expected revenue from government orders, cost savings, cash flow, increasing margins and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: our ability to satisfy customer demand; ability to reduce our spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to market and sell our products and services, whether through our internal, direct sales force or third parties; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; significant customer concentrations that exist or may develop in the future; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; impact of replacing distributors; inventory levels at distributors and other customers; our ability to achieve its financial and strategic objectives and increase our revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of our products and services; ability to achieve the anticipated benefits from the BioMedomics transaction; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to achieve and maintain sustained profitability; ability to increase our gross margins; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents, trade secrets and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms on international sales; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity incidents and other disruptions involving our computer systems or those of our third-party IT service providers, suppliers and customers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including interest rates, inflationary pressures, capital market disruptions, changes in governmental agencies, international tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements. Statement Regarding Use of Non-GAAP Financial Measures In this press release, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures, including non-GAAP gross margin, non-GAAP gross profit, non-GAAP net income (loss), non-GAAP operating income (loss), and non-GAAP earnings (loss) per share. Management believes that presentation of operating results using these non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods, while excluding certain expenses that may not be indicative of the Company’s recurring core business operating results. In addition, management believes these non-GAAP financial measures are useful to investors both because they (1) allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) are used by OraSure’s institutional investors and the analysis community to help them analyze the health of OraSure’s business. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the schedules below and a description of the adjustments made to the GAAP financial measures is included at the end of the schedules. The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's, except per share amounts) The following is a description of the adjustments made to GAAP financial measures: Stock Compensation: non-cash equity-based compensation provided to OraSure employees and directors Amortization of acquisition-related intangible assets: represents recurring amortization charges resulting from the acquisition of intangible assets associated with our business combinations Reduction in workforce severance: termination benefits associated with the Company’s workforce reduction associated with certain business Gain on sale of assets under product line discontinuance: represents the gain on the sale of fixed assets associated with the risk assessment line of business that was discontinued and sold to a 3rd party Change in fair value of acquisition-related contingent consideration: changes in the fair value of contingent consideration liability associated with an adjustment for the passage of time Loss on equity investment: we have excluded our proportionate share of our equity method investee’s net loss as we do not have direct control over the investee’s operations or resulting revenue and expenses Tax impact associated with non-GAAP adjustments: tax expense/(benefit) due to non-GAAP adjustments A reconciliation of our non-GAAP measures to their most directly comparable GAAP measures can also be found at: https://orasure.gcs-web.com/gaap-non-gaap-reconciliation

Image source: The Motley Fool. May 6, 2026, 5 p.m. ET President and Chief Executive Officer — Carrie Eglinton Manner Chief Financial Officer — Kenneth J. McGrath Carrie Eglinton Manner, our President and Chief Executive Officer, and Kenneth J. McGrath, our Chief Financial Officer. As a reminder, today's webcast is being recorded; 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 OraSure Technologies, Inc.’s SEC filings, its annual report on Form 10-K for the year ended 12/31/2025, 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. OraSure Technologies, Inc. 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. Carrie Eglinton Manner: Thanks, Jason, and thank you to everyone for joining us today. Today, I will 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 are 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 are 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 are also preparing for several near-term catalysts for growth, including our two product launches planned for midyear: 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 channel and in expanding the reach of Sickle SCAN 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 health care 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 will 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 midyear 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 SHERLOC molecular diagnostic platform, and our COLI P device for STIs. The COLI P submission, which includes its proprietary stabilization chemistry, covers multiple STI indications and is being pursued in collaboration with a leading diagnostic 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 will turn the call over to Ken to discuss our financial results and guidance. Kenneth J. McGrath: Thanks, Carrie. Total revenue in the first quarter was $27.9 million and grew 4% on a sequential basis. Diagnostic products generated $16.9 million of revenue in Q1, with a fairly even split between U.S. and international revenue. Diagnostics revenue grew 12% on a sequential basis. Sample Management Solutions revenue in Q1 was $9.1 million, which was basically flat on a sequential basis. Our GAAP gross margin in the first quarter was 42.3% compared to 41.1% in Q1 2025, and non-GAAP gross margin in Q1 increased to 43.4% compared to 41.7% in Q1 2025. Gross margin expansion was driven by operating efficiencies, largely related to our initiatives to insource production from third-party contract manufacturers into our Pennsylvania facilities. This transition leverages our advanced manufacturing capabilities and capacity developed during the COVID-19 pandemic. Looking at GAAP operating expenses in Q1, R&D expense was $13.7 million, sales and marketing expense was $6.8 million, and general and administrative expense was $14.6 million. The increase in R&D was primarily driven by investments in activities related to launch preparation and production readiness for our CT and G test and our COLI P device, including studies gathering data that we believe will position us for a successful commercial go-to-market launch. We expect our R&D expense to taper down during Q2 and Q3. Looking at G&A expense, the sequential increase in Q1 was primarily driven by nonrecurring items, including severance expense related to a reduction in force in February, professional services related to our proxy, and the annual reset of accruals for performance-based incentive compensation programs. We expect G&A expense to decline to more normalized levels beginning in Q3 following the conclusion of the nonrecurring items I mentioned. Non-cash stock compensation expense in the first quarter was $2.8 million, and depreciation and amortization expense was $2.3 million. Our GAAP operating loss in Q1 was $23.3 million, and our non-GAAP operating loss was $19 million. Moving to our balance sheet, we ended the quarter with zero debt and total cash and cash equivalents of $177 million. During the first quarter, we deployed $5 million to repurchase 1.8 million shares of our common stock. Over the last four quarters, we have returned $20 million of capital to shareholders through the repurchase of 7.1 million shares. Consistent with our balanced capital deployment strategy, we continue to evaluate organic and inorganic opportunities that can accelerate our profitable growth in high-value markets and leverage our existing capabilities. Operating cash flow in the first quarter was negative $14 million, which was consistent with our expectations. As we discussed in February, we expect to return to breakeven from an operating cash flow standpoint as we enter 2027. This view is supported by our outlook for revenue growth, including contributions from our anticipated product launches, as well as our continued focus on delivering cost savings and operating efficiencies. Moving to guidance, we expect revenue in the second quarter of $27 million to $30 million, which includes a negligible amount of revenue for COVID-19 testing. We expect our gross margin in Q2 to be similar to Q1. We anticipate our operating expense will be in the high $20 millions in Q2, which includes non–run-rate expenses and excludes stock compensation. Then we expect operating expenses to decline further to the mid-$20 millions in Q3 as non–run-rate expenses wind down. With that, I will turn the call back to Carrie to conclude. Carrie Eglinton Manner: Thanks, Ken. As we move through 2026, OraSure Technologies, Inc. is positioned to accelerate our growth as we approach a series of regulatory and commercial milestones, and we continue to transform our business as we deliver on our strategy to decentralize diagnostics. We are excited about all of our opportunities, near term and long term, to expand our portfolio with our innovative product pipeline and our ability to leverage our manufacturing capabilities and capacity, as we work to create value for our customers and all shareholders. With that, I am pleased to turn the call over to the operator for Q&A. Operator: We will now open the call for questions. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Our first question comes from the line of Patrick Donnelly from Citi. Your line is now open. Analyst: Hi. This is Brandon on for Patrick. Thank you so much for taking our questions, and congrats on the quarter. I first want to start on the nearshoring initiatives. Great to see orders kind of start to come through there. I was wondering if you would be able to size those and, down the line as more are added, what those could potentially turn into from a revenue standpoint? And then also along those lines, can you talk about what the pipeline looks like to add more sites to that program? Carrie Eglinton Manner: Thanks, Brandon. As far as nearshoring, we are really excited about the opportunity. For background, this is something that we have been working with these countries for several years to put in place. We said it was significant; we have not given an exact number as far as dollars, but you can imagine “in the millions” is significant for us. Not all relationships will be in that range, but we are seeing good progress as we continue to advance conversations and initiate nearshoring opportunities with other countries as well. Analyst: Thank you. And then to touch on the margins, it is good to see the first quarter come in ahead of expectations. Should we view this as a new baseline for gross margins? And is there more internal insourcing or similar initiatives that you are planning on implementing to further that margin expansion? Kenneth J. McGrath: Yes, thanks. As we said, Q2 will be similar to Q1. The tailwinds for improving our margins are our operational efficiencies, which you may recall we have discussed in the past where we consolidated our manufacturing into some core operation facilities. As we take advantage of those operating efficiencies overall and our improved absorption, and in addition as we increase our volumes, we will continue to see improvements in our gross margin. That could be offset, obviously, from time to time by mix and other dynamics that play out within our margins, but we are encouraged by the strong tailwinds that we have. Operator: One moment for our next question. The next question comes from the line of Mac Etok from Stephens. Your line is now open. Mac Etok: Hey, good afternoon, and thank you. On the outlet for the CT and G test, as you approach the launch of these products, I assume the commercial teams are already advancing discussions around agreements and partnerships. What progress have you made on that front so far, and how should we think about the early commercialization traction there? Carrie Eglinton Manner: Hi, Mac. You are right that when you have the product launch expectation, everybody starts gearing up. There is an important distinction to be made, of course, with FDA-cleared products: unlike research-use-only, you really cannot premarket. We do, of course, understand market interest and opportunity in infectious disease, in STIs, and in sample and urine collection because we have such strong portfolios there today. We have done good market research, we stay very connected to these customers, and we are thinking about the kinds of conversations you can have ahead of time, which are really about how the whole test-to-treat system would work upon clearance. Those dialogues—all within bounds—give a sense for the enthusiasm and interest to make STI testing private, convenient, affordable, and accessible, and to make urine self-collection something that can be done outside of a doctor’s office. With the FDA process, we are also very smart and compliant around not premarketing. Mac Etok: Fair enough, I appreciate the color there. And then maybe following up on the margin question: as you think about the launch of some of these products in the pipeline, should we expect any near-term volatility or decremental margins as we think about near-term margin progression? Kenneth J. McGrath: What we have said for CT and G is that, in the fullness of time, it will be accretive to our overall margins. But to your point, there is a ramp-up; when your volumes start out lower, you do not have as strong margins. We will experience some of that as we ramp. For our COLI P device, similarly, we expect margins in the fullness of time to be equal to or accretive to our overall current margins. But there is that ramp-up period, as we increase volumes and achieve full absorption over time. Carrie Eglinton Manner: Thanks, Mac. Operator: Thank you. I am showing no further questions at this time. I would now like to turn the call back to Carrie for closing remarks. Carrie Eglinton Manner: Thanks, and thank you to everyone for joining us. We hope you have a great day, and with that, we will close the call. Thanks. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in OraSure Technologies, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and OraSure Technologies wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $473,985!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,204,650!* Now, it’s worth noting Stock Advisor’s total average return is 950% — a market-crushing outperformance compared to 203% for the S&P 500. 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OraSure reported Q1 revenue of $27.9 million (up 4% sequentially) with diagnostics up 12%, and improved gross margins to 42.3% GAAP (43.4% non‑GAAP) driven by insourcing manufacturing; management expects Q2 margins to be similar to Q1. The company is awaiting FDA review of two planned mid‑year launches — an OTC rapid molecular CT/NG self‑test (Sherlock platform) and the Colli‑Pee at‑home urine collection device — and anticipates both products will begin contributing revenue in the second half of 2026, though early ramping may pressure margins before becoming accretive. OraSure posted a Q1 GAAP operating loss of $23.3 million but finished the quarter with $177 million in cash and zero debt, repurchased $5 million of stock in Q1 (about $20 million over the past year), expects to return to break‑even operating cash flow entering 2027, and guided Q2 revenue of $27–30 million. Interested in OraSure Technologies, Inc.? Here are five stocks we like better. OraSure Technologies (NASDAQ:OSUR) reported first-quarter 2026 revenue of $27.9 million, topping the midpoint of its prior guidance range, as the company pointed to improving gross margins, ongoing cost actions, and preparations for two planned mid-year product launches that management expects to begin contributing revenue in the second half of the year. Chief Financial Officer Ken McGrath said total revenue was $27.9 million in the first quarter, up 4% sequentially. Diagnostic products generated $16.9 million, with a “fairly even split between U.S. and international revenue,” and diagnostics revenue rose 12% sequentially. Sample management solutions revenue was $9.1 million, which McGrath described as “basically flat on a sequential basis.” → Tyson Foods' Total Returns: Tasty Treats for Income Investors? President and Chief Executive Officer Carrie Eglinton Manner said the company continues to “advance our strategic transformation and execute with discipline,” including efforts to leverage manufacturing capacity to expand gross margins while streamlining costs. She also said OraSure is “elevating our core growth by expanding and diversifying our product portfolio and customer relationships” as several end markets adapt to a changing funding environment. In international diagnostics, Manner highlighted progress with “distribution partners in Africa” tied to “in-country value-added assembly and manufacturing, also known as nearshoring.” She said OraSure delivered on initial orders to one nearshoring partner in the quarter and anticipates initial orders from other partners in the second half of the year. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? In the U.S. diagnostics business, Manner said public health customers are stabilizing as they adjust to current budgets, and that HIV testing “remain[s] a key priority for state and local public health agencies.” She also said the company is seeing demand for its “syndemic approach” that leverages rapid tests across conditions including HIV, hepatitis C (HCV), and syphilis. In sample management solutions, Manner said the company is seeing “gradual improvement with commercial customers,” including advanced genetic testing labs tied to increased utilization of precision medicine and rare disease diagnostics. However, she said 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.” → A Prada Payday: Is AMC Back in Style? OraSure reported GAAP gross margin of 42.3% in the first quarter, up from 41.1% in the year-ago period. Non-GAAP gross margin was 43.4% compared to 41.7% a year earlier. McGrath attributed the expansion to “operating efficiencies,” primarily related to insourcing production from third-party contract manufacturers into the company’s Pennsylvania facilities—capacity developed during the COVID pandemic. Asked on the call whether first-quarter margins represent a new baseline, McGrath said the company expects second-quarter gross margin to be “similar to Q1.” He added that improved absorption from consolidated manufacturing and higher volumes could support margin improvement over time, while noting mix and other factors could still cause periodic variation. Manner reiterated that OraSure is preparing for “two product launches planned for mid-year”: an over-the-counter rapid molecular self-test for chlamydia and gonorrhea (CT/NG) built on the Sherlock molecular diagnostics platform, and the Colli-Pee at-home urine collection device for sexually transmitted infections. She said both FDA clearance applications are currently under review and the company continues to anticipate mid-year clearances, with revenue expected to ramp in the second half of the year. Manner said the Colli-Pee submission includes proprietary stabilization chemistry and “covers multiple STI indications,” and is being pursued “in collaboration with a leading diagnostics platform provider.” She described the submissions as progress toward a strategy to decentralize diagnostics and connect people to care that is “more accessible, convenient, affordable, and private.” During Q&A, management addressed commercialization planning for the CT/NG test and Colli-Pee, while emphasizing limits on pre-marketing prior to FDA clearance. Responding to a question from Stephens analyst Mac Etoch, management said the company is staying connected to customers and focusing on conversations around how “the whole test-to-treat system would work upon clearance,” while remaining “smart and compliant around not pre-marketing.” McGrath also discussed expected margin dynamics as new products scale. He said OraSure expects CT/NG to be accretive to overall margins “in the fullness of time,” but that there may be pressure early in the ramp as volumes start lower. He offered a similar expectation for the Colli-Pee device, with margins equal to or accretive to current levels over time as volumes rise and absorption improves. OraSure posted a GAAP operating loss of $23.3 million in the first quarter and a non-GAAP operating loss of $19.0 million. McGrath said first-quarter GAAP operating expenses included R&D of $13.7 million, sales and marketing of $6.8 million, and general and administrative expense of $14.6 million. McGrath said the rise in R&D was driven primarily by launch preparation and production readiness for CT/NG and Colli-Pee, including studies intended to support commercial go-to-market efforts. He said the company expects R&D expense to “taper down during Q2 and Q3.” G&A increased sequentially due to “non-recurring items,” including severance related to a February reduction in force, professional services related to the company’s proxy, and the annual reset of incentive compensation accruals. McGrath said G&A is expected to decline to more normalized levels beginning in the third quarter as those items roll off. On the balance sheet, OraSure ended the quarter with “zero debt” and $177 million in cash and cash equivalents. The company used $5 million during the quarter to repurchase 1.8 million shares. McGrath said that over the last four quarters OraSure has returned $20 million to shareholders through repurchases totaling 7.1 million shares, while continuing to evaluate organic and inorganic opportunities that could accelerate profitable growth in “high-value markets.” Operating cash flow was negative $14 million in the first quarter, which McGrath said was consistent with expectations. He reiterated a view shared in February that the company expects to return to break-even operating cash flow “as we enter 2027,” supported by anticipated revenue growth including contributions from planned launches and ongoing cost savings. For the second quarter, McGrath guided to revenue of $27 million to $30 million, which includes a “negligible amount of revenue for COVID-19 testing.” He said gross margin in Q2 is expected to be similar to Q1. Operating expense is projected to be in the “high $20 million range” in Q2 (excluding stock compensation) and to decline to the “mid $20 millions” in Q3 as non-run-rate expenses wind down. On nearshoring, Citi’s Brendan (on for Patrick Donnelly) asked management to size early orders and discuss the pipeline. McGrath said the company has not provided an exact dollar figure but suggested the opportunity is meaningful, saying investors can “imagine in the millions is significant for us,” while adding that not all relationships will be at that level. He said the company is seeing progress as it continues conversations and initiates nearshoring opportunities with additional countries. Manner closed the call by saying OraSure is positioned to “accelerate our growth as we approach a series of regulatory and commercial milestones” and remains focused on transforming the business and executing its strategy to decentralize diagnostics. OraSure Technologies, Inc is a Bethlehem, Pennsylvania–based diagnostic and medical device company specializing in the development, manufacture and commercialization of point-of-care and self-testing products. Founded in 1988, OraSure has built a portfolio of oral fluid and other non-invasive specimen collection technologies that support the detection of infectious diseases, drugs of abuse, and health and wellness biomarkers. The company's flagship product, the OraQuick® rapid HIV test, was the first Food and Drug Administration–approved over-the-counter oral fluid test for the detection of HIV-1/2 antibodies. The article "OraSure Technologies Q1 Earnings Call Highlights" was originally published by MarketBeat.