OraSure (OSUR) Q3 2025 Earnings Call Transcript

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DATE

Wednesday, Nov. 5, 2025 at 5 p.m. ET

CALL PARTICIPANTS

President and Chief Executive Officer — Carrie Eglinton Manner

Chief Financial Officer — Kenneth J. McGrath

Operator

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RISKS

International diagnostics revenue is projected to decline approximately 20% for full year 2025 compared to 2024, with management explicitly noting this is due to lower HIV test orders as partners work through inventory and respond to changes in funding.

Management indicated an environment with elevated levels of uncertainty related to funding for public health programs and research, as well as the government shutdown in the US, signaling an ongoing external demand headwind.

The consumer genetics customer headwind persists, with revenue from this segment is expected to remain lower in Q4 2025 due to continued disruptions in ordering patterns.

Operating loss reached $16.1 million in Q3 2025, while operating cash flow was negative $10 million in Q3 2025, reflecting continued near-term pressure on profitability and cash generation from investments in R&D and innovation.

TAKEAWAYS

Total Revenue -- $27.1 million total revenue for Q3 2025, with core revenue at $27 million; this excludes COVID-19 products and exited businesses.

Diagnostics Revenue -- Diagnostics revenue was $14.5 million, driven by both international and US segments.

Sample Management Revenue -- $10.3 million for Sample Management Solution revenue in Q3 2025, with core customer base (excluding the consumer genetics customer) showing year-over-year growth.

GAAP Gross Margin -- 43.5% gross margin for Q3 2025, slightly above expectations due to lower scrap expenses and operational efficiencies.

Non-GAAP Gross Margin -- 44.2% non-GAAP gross margin, achieving a modest gain above internal forecasts.

GAAP Operating Expenses -- Operating expenses were $27.9 million in Q3 2025, including $2.8 million in noncash stock compensation in Q3 2025 and $376,000 from acquisition-related contingent consideration adjustment in Q3 2025.

GAAP Operating Loss -- Operating loss was $16.1 million for Q3 2025, and Non-GAAP Operating Loss -- Non-GAAP operating loss was $12.7 million.

Total Cash and Cash Equivalents -- Ended the quarter at $216 million with zero debt.

Operating Cash Flow -- Negative $10 million operating cash flow, aligned with expectations given ongoing platform investments.

Share Repurchase -- $5 million was used to buy back approximately 1.5 million shares.

Q4 Revenue Guidance -- Forecasted Q4 2025 revenue at $25 million to $28 million, with less than $100,000 expected from COVID-19 products.

Q4 Gross Margin Guidance -- Low 40% range gross margin for Q4 2025, expected to be lower than Q3 due to seasonality and increased international mix.

Q4 Operating Expense Guidance -- Core expenses around $20 million for Q4 2025; innovation investment of $10 million (including $7 million-$8 million for SHERLOC development).

International Diagnostics Annual Outlook -- Revenue now expected in the low to mid $30 million range for full year 2025, "representing a decline of approximately 20%" per management compared to 2024, as national health programs adapt to funding environment changes.

US Diagnostics Annual Outlook -- Revenue projected in the low to mid $30 million range for full year 2025, corresponding to a low single-digit percentage decline.

Sample Management Full-Year Outlook -- Revenue expected in the high $30 million range for full year 2025, approximately flat compared to 2024, excluding the impact of the decline in orders from the consumer genetics customer.

BioMedomics Acquisition -- Definitive agreement signed for $4 million upfront plus potential contingent payments, targeting sickle cell diagnostics for underserved international markets.

BioMedomics Revenue Contribution -- Currently near $1 million in annual revenue, with potential to reach several million over several years and expected to be cash flow breakeven as integration leverages existing infrastructure.

Together Take Me Home Program -- Renewed for a fourth year, with management expecting to recognize approximately $1.8 million in revenue in Q4 2025 and similar quarterly run-rate in 2026.

Product Pipeline Progress -- Mid-year launch of HemaCollect protein product for RUO markets; ColliPea clinical trial data FDA submission targeted for late 2025 or early 2026; SHERLOC platform’s first CTNG assay progressing toward an FDA submission in the same timeframe.

Board Updates -- Three new independent directors added in the last three years, with Stephen K. Boyd the most recent and Jack Kenny appointed chair; Mara Aspinall stepping down after eight years of service.

SUMMARY

Management described 2025 as a "transition year" according to Carrie Eglinton Manner and positioned OraSure Technologies (NASDAQ:OSUR) projects a return to growth in 2026, underpinned by recent product innovation and expanded international commercial capabilities. Their guidance calls for a sequential revenue decline in Q4, with Gross margins (including non-GAAP) are expected to dip below Q3 2025 due to seasonality and an increased share of international revenue. The acquisition of BioMedomics is focused on rapid sickle cell testing for high-burden geographies outside the US and is expected to have minimal incremental operating expense due to integration within existing infrastructure. The ongoing headwinds in international diagnostics and consumer genetics sharply impact current growth rates, yet management emphasized a strong cash position and continued commitment to innovation investment as key to future outperformance.

CEO Eglinton Manner identified "elevated levels of uncertainty related to funding for public health programs and research, as well as the government shutdown in the US" as major challenges being actively managed.

Nonpublic health channels—such as urgent care and correctional facilities—are cited by management as expanding opportunities for the diagnostics segment, with new customer bases targeted for rapid hepatitis C and other condition testing.

Inclusion in the ENDO 1000 study in the UK for multiple sample types is presented as evidence of market validation for OraSure Technologies' collection kits, as described in the Q3 2025 earnings call, contributing to confidence in the precision health and clinical research pipeline.

Management stated that innovation investments, particularly within SHERLOC and ColliPea platforms, directly support the company's long-term shift toward decentralizing diagnostics and increasing self-collection adoption for genomic, STI, and infectious disease testing.

INDUSTRY GLOSSARY

CTNG: Acronym for chlamydia and gonorrhea, commonly used for diagnostic assays targeting these two sexually transmitted infections.

RUO: Stands for "Research Use Only," indicating a product is intended strictly for laboratory or research purposes and not approved for clinical diagnostics.

Sherloc Platform: OraSure Technologies' over-the-counter molecular diagnostic rapid test platform, initially targeting self-testing for chlamydia and gonorrhea (CTNG).

Sample Management Solutions (SMS): Category encompassing collection, stabilization, transportation, and storage of biological samples for genomic and molecular testing.

Full Conference Call Transcript

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 and the recording can be found on our Investor Relations website. Before we begin, you should know that this call may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share, and other financial performance, product development, shipments and markets, business plans, regulatory filings and approvals, expectations, and strategies. Actual results could be significantly different.

Factors that could affect results are discussed more fully in OraSure Technologies, Inc.'s SEC filings, its annual report on Form 10-K for the year ended December 31, 2024, its quarterly reports on Form 10-Q, and its other SEC filings. Although forward-looking statements help to provide more complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today. OraSure Technologies, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I'm pleased to turn the call over to Carrie.

Carrie Eglinton Manner: Thanks, Jason, and thank you to everyone for joining us today. Today, I'll discuss some highlights from Q3 and our progress on key priorities for 2025 and beyond. Overall, we continue to significantly advance our strategic transformation and execute with discipline as we position OraSure Technologies, Inc. for a return to growth in 2026. We have delivered meaningful progress and continue strengthening our foundation. We're also elevating our core growth by expanding and diversifying our product portfolio and customer relationships. Plus, we're accelerating profitable growth through investments in internal R&D as well as acquisitions and partnerships that leverage our existing capabilities and that offer an attractive risk-adjusted ROI.

Looking at our Q3 results, total revenue was $27.1 million and core revenue was $27 million, which included diagnostics revenue of $14.5 million and sample management revenue of $10.3 million. Broadly speaking, our key end markets remain mixed. And we continue to partner with customers that are navigating an environment with elevated levels of uncertainty related to funding for public health programs and research, as well as the government shutdown in the US. That said, we view 2025 as a transition year. And we're excited about pipeline opportunities in attractive markets that align with our strength to drive growth in 2026 and beyond.

In our international diagnostics business, we discussed on our last earnings call that we anticipated a slower pace of orders for our HIV test in the second half of the year as our in-country partners work through their existing inventory and national health programs adapt to changes in the funding environment. That trend played out as expected in Q3 and thus far in Q4. For the full year 2025, we now expect that revenue from our international diagnostics business will be in the low to mid $30 million range, representing a decline of approximately 20% compared to 2024, which was a record year for international diagnostics.

Staying with our international business, we are pleased to share that OraSure Technologies, Inc. signed a definitive agreement to acquire BioMedomics. This tuck-in acquisition expands OraSure Technologies, Inc.'s diagnostic portfolio by adding SickleScan, a rapid point-of-need test for sickle cell disease that is sold outside the US. The global sickle cell testing market, particularly in high-burden regions and developing markets, is underserved and fragmented. We believe SickleScan addresses this need with a high-quality, affordable, rapid point-of-care test. And there is support from government agencies and global health organizations to increase access to sickle cell testing at the point of need.

We see an opportunity to expand the reach and adoption of SickleScan by leveraging OraSure Technologies, Inc.'s strength, including our international sales channels and our existing relationships with national health programs, particularly in Africa and Latin America. Furthermore, many of our international customers and partners have expressed interest in a reliable, low-cost, rapid diagnostic test for sickle cell disease. Transitioning to our US diagnostics business, our public health customers are adapting to significant reductions in staffing at HHS, CDC, SAMHSA, and other federal agencies that support public health programs, along with budgetary uncertainty and challenges related to the federal government shutdown.

We are continuing, however, to see traction with our syndemic approach that leverages our portfolio of rapid tests across multiple conditions. And we are expanding our customer base in nonpublic health markets such as urgent care, hospital emergency rooms, and correctional facilities for rapid hepatitis C testing, plus online channels specializing in consumer-initiated testing. Overall, for the full year 2025, we expect our US diagnostics business to generate revenue in the low to mid $30 million range, representing a low single-digit percentage decline compared to 2024.

We also wanted to provide an update on Together Take Me Home, a collaboration funded by the federal government that makes HIV self-tests available through the mail in order to advance the president's goal of ending the HIV epidemic. We are pleased to share that this highly effective, life-saving program was renewed by the Trump administration with strong bipartisan support in Congress. As a result, Together Take Me Home is continuing for program year four, which runs from October 2025 to September 2026. We expect to recognize approximately $1.8 million of revenue from Together Take Me Home in Q4 and anticipate a similar pace of quarterly revenue in 2026.

Switching gears to our Sample Management business, the overall trend continues to be mixed. SMS revenues increased on a quarter-over-quarter basis in Q3, but we anticipate a sequential decline in Q4, which is consistent with the typical seasonal ordering pattern for this business. For the full year, we expect revenue from Sample Management products in the high $30 million range, which would be approximately flat compared to 2024 if you exclude the impact of the decline in orders from a large consumer genetics customer. Looking ahead, we are confident that the Sample Management business is positioned to return to growth in 2026 and beyond as genomic end segments gradually return to stronger growth driven by clinical adoption of precision medicine.

Our confidence is also supported by continued scientific and technological advancements, such as the increasing utilization of short-read and long-read genomic sequencing, the decline in unit cost for sequencing analysis, and advancements in areas such as proteomics. We are also seeing early signs of positive trends in some international markets, such as the Middle East, that are planning to invest in population health studies using novel sample collection devices in order to accelerate precision health and life sciences research in the region. We're also pleased to share that the ENDO 100 project has selected multiple kits from our Omnigene and ColliPea product lines for collection and stabilization of a variety of sample types, including saliva, urine, stool, and vaginal swab.

The ENDO 1,000 project is a United Kingdom-wide initiative aimed at accelerating the discovery and advancing data-driven research into the diagnostics and personalized treatments of endometriosis. By collecting biological samples and lifestyle data from participants over two years, the study seeks to uncover patterns that can inform more effective individualized care strategies. The inclusion of our sample collection kits in this landmark study underscores their value in enabling high-quality research and positions us for continued growth in the precision health and clinical research segments. Now I'll transition to our exciting pipeline of innovation, including an update on several products targeting attractive markets.

Mid-year, we launched a blood collection tube with stabilization chemistry for research use only or RUO markets in the burgeoning field of proteomics. We also anticipate near-term milestones for ColliPea urine collection, initially for sexually transmitted infection, or STI, indications, and future expansion into liquid biopsy. And our SHERLOC molecular diagnostics rapid test platform, whose first assay is expected to serve the large and growing chlamydia and gonorrhea or CTNG segment of STI. As we discussed last quarter, our HemaCollect protein product launched in July 2025 in the RUO market, like I just mentioned.

Since this launch, we've received positive and insightful feedback from our customers and early adopters that will help inform our roadmap as we enhance our proteomics product line and build additional momentum in 2026. Additionally, OraSure Technologies, Inc. is presenting at the upcoming Human Proteome Organization World Congress to highlight HemoCollect protein's proprietary stabilization capabilities and its performance across a range of proteomics technology platforms. Moving to our ColliPea device, which is designed for first void urine collection, we plan to submit clinical trial data to the FDA for STI indications by late 2025 or early 2026.

Receipt of approval for these applications, subject to regulatory review, would be in addition to our existing ColliPea RUO product and is expected to further strengthen our competitive position in novel urine collection. Our analytical and clinical studies are demonstrating strong performance and flexibility across multiple target analytes. We're in advanced discussions with leading diagnostics platform providers that are interested in enabling self-collected noninvasive testing across large and growing markets, including STIs, HPV, and other disease states. Next in product innovation, regarding our SHERLOC over-the-counter molecular diagnostic self-test platform and its first assay for CTNG, we are making good progress in our clinical trial and our plan for submission to the FDA in late 2025 or early 2026.

We anticipate gaining momentum for our product launches for innovation. And it's the work we've done in transforming our enterprise that also allows us to invest in creating a pipeline of earlier-stage opportunities in high-value growth markets that fit well with our strengths and our product platforms where we can compete and win. Examples include categories where we already have a presence, like infectious disease and STI, plus the newer ones like liquid biopsy or, say, antimicrobial resistance, where rapid tests and differentiated chemistries have outsized potential to create and add value. We look forward to sharing more details as new product opportunities progress through our development process.

With that, I'll turn the call over to Ken to discuss our financial results and guidance.

Kenneth J. McGrath: Thanks, Carrie. Total revenue in the third quarter was $27.1 million. Core revenue, which excludes COVID-19 products and the molecular services and the risk assessment testing businesses that we exited, was $27 million. Diagnostic products generated $14.5 million of revenue in Q3, and Sample Management Solution revenue was $10.3 million. Excluding the headwind from the consumer genetics customer, Sample Management revenue from the rest of our customer base grew on a year-over-year basis in Q3. Our GAAP gross margin in the third quarter was 43.5%, and non-GAAP gross margin was 44.2%, which was slightly better than our expectations due to lower scrap expenses.

GAAP operating expenses in the third quarter were $27.9 million, which includes $2.8 million of noncash stock compensation expense and $376,000 of expense related to an increase in the estimated fair value of acquisition-related contingent consideration. Depreciation expense was $2.6 million in the quarter. Our GAAP operating loss in Q3 was $16.1 million, and our non-GAAP operating loss was $12.7 million. Looking at our balance sheet, we ended Q3 with zero debt and total cash and cash equivalents of $216 million. Operating cash flow in the third quarter was negative $10 million, which was consistent with Q2 and our expectations given our investments in the SHERLOC platform, the CTNG clinical trial as its first assay, and other innovation projects.

We deployed $5 million during the third quarter to repurchase approximately 1.5 million shares of our common stock. Consistent with our capital deployment strategy, we also continue to evaluate organic and inorganic growth opportunities. As Carrie mentioned, we have signed a definitive agreement to acquire BioMedomics as a tuck-in commercial stage acquisition for $4 million upfront and potential contingent consideration upon achievement of revenue milestones. BioMedomics is currently approaching $1 million of annual revenue, and we believe OraSure Technologies, Inc. has the potential to grow that to several million dollars of annual revenue over the next few years.

BioMedomics is expected to be cash flow breakeven, with a path to a very attractive ROI as revenue grows over the next few years. We anticipate minimal incremental operating expense for OraSure Technologies, Inc. given that BioMedomics can be plugged into OraSure Technologies, Inc.'s international commercial organization and leverage our administrative and regulatory capabilities to expand availability and adoption of the SickleScan rapid test. Turning to guidance, we are guiding to fourth quarter revenue of $25 million to $28 million, which includes less than $100,000 of COVID-19 testing revenues. Our guidance also assumes continued disruption in ordering patterns from our SMS customer in the consumer genetics industry. This customer represented approximately $4 million of revenue in Q4 last year.

We expect our gross margin percentage in Q4 to be in the low 40% range, which is slightly lower than the third quarter due to typical seasonality and a greater mix of international revenue as a percentage of total revenue in Q4. Moving to operating expenses, in Q4, we expect core operating expenses of approximately $20 million plus $10 million of investments in innovation, which includes $7 million to $8 million of investments related to SHERLOC. With that, I'll turn the call back to Carrie to conclude.

Carrie Eglinton Manner: Thanks, Ken. We'll plan to exit the transition year of 2025 and head into 2026 with important near-term catalysts for growth as we advance into the next phase of our multiyear strategy. We've done the work in the last three years that gives us the confidence and the capabilities we need to achieve our goals. We have delivered cost productivity at the business level and product level, developed our people and infused new talent in the organization, leveraged our commercial strength to diversify our customer base, implemented enterprise-wide rigor, and built a strategic innovation roadmap.

We've strengthened our cash flow profile while maintaining a strong balance sheet that has allowed us to invest in attractive innovation pipeline opportunities, including internal product development along with M&A. We've also refreshed our board with the addition of three new independent directors over the last three years, including last week's announcement adding Stephen K. Boyd as a director and appointing Jack Kenny as chair of the board. Also, we'd like to thank Mara Aspinall, who has decided to step down after over eight years of service to pursue new opportunities. We're grateful for her many contributions and wish her the very best. Our foundation is strong, but our work is not done.

We recognize that in order to capitalize on the many opportunities ahead of us, we must continue to execute on our priorities and deliver more innovation. Our entire team is working with urgency and is aligned in purpose to decentralize diagnostics and connect people to care that is more accessible, convenient, private, and personalized to create long-term value for customers and shareholders. We're confident in the path ahead. With that, I'm pleased to turn the call over to the operator for Q&A. Operator?

Operator: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your questions, simply press 1 again. If you are called upon to ask your question and are listening via speakerphone on your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Our first question comes from Mac Etok from Stephens Inc. Please go ahead. Hi, Mac.

Mac Etok: Hey, Carrie. How are you doing? Appreciate you all taking my questions. Just a few for me, and I'll let some others add some. But maybe could you just discuss this BioMedomics acquisition and what attracted you to that asset? Just to start, and I'll go from there.

Carrie Eglinton Manner: Yeah. It's a really nice tuck-in that aligns precisely with our portfolio internationally. So rapid diagnostic testing for underserved markets. You know, the strength we have in Africa, including, you know, we don't talk as much about Latin America. But for low-cost tests that identify, you know, pressing healthcare challenges, whether it's the infectious disease success we've had in HIV or HCV, you know, sickle cell is one of those opportunities where the populations in those underserved regions are often undiagnosed. So we had heard that need. We've been, you know, talking with BioMedomics for many years and, you know, working with them.

And so the opportunity to bring that to tuck that into our portfolio, leverage the strength of our relationships, our commercial distribution and reach, and just put it right into the portfolio made a ton of sense. So, you know, a very promising potential for what we think are smart capital deployment.

Kenneth J. McGrath: And, Mac, we also think it has a strong return on invested capital. You know, in the deal structure, we said it's a small upfront with some contingent considerations if they achieve certain milestones, you know, three to five years out. We believe that structure allows us to really deliver value. We mentioned also that it'll be breakeven cash flow. And what that, as Carrie mentioned, it's leveraging a lot of our capabilities. So we really don't need to add a lot to deliver this and to put it into our channel. And then as we grow the revenue, we'll be able to leverage and be accretive going forward.

Mac Etok: I appreciate the context there. And then secondly, pretty good cost management on your part both at the gross margin level and in terms of OpEx. Just given where revenues fell, can you just highlight some of the puts and takes around gross margins and then given the insourcing was completed in 2Q, are there any lingering costs that might have fallen into the quarter?

Kenneth J. McGrath: Yeah. That's a great question. Yeah. For gross margins, we did do a little bit better than guided and expected. A lot of that was driven by our lower scrap than expected, which is really a compliment to our operations team and their continued automation and operational efficiencies. As far as OpEx, that was in line with our spend. And really, you know, our core business essentially is breakeven, and where we do choose to spend our dollars beyond that are on innovation. And in this case, innovation focused on delivering our SHERLOC CTNG clinical trial submission, as well as internal innovation. And then a little bit of other benefits of gross margins.

There was a little bit of a mix benefit in Q3. And we did mention we guided in Q4 that we'll be a little bit below Q3. Part of that is the mix seasonality and the mix change where we expect to see a little bit more international revenue in Q4 as a mix, which will lower the margins a bit.

Mac Etok: I appreciate the context. I'll jump back in the queue.

Operator: Thanks, Mac. Again, if you would like to ask a question, please press 1. There are no further questions at this time. I would now like to turn the call back over to Carrie Eglinton Manner for closing remarks.

Carrie Eglinton Manner: Thank you, Mac, for your questions and to everybody for participating today. We appreciate your continued interest in OraSure Technologies, Inc. And with that, we'll close the call. Thank you.

Operator: This concludes today's conference call. Thank you for joining. You may now disconnect.

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