OraSure at Stephens Conference: Strategic Growth and Innovation

On Wednesday, 19 November 2025, OraSure Technologies (NASDAQ:OSUR) presented at the Stephens Annual Investment Conference, outlining its strategic direction and financial performance. The company showcased its commitment to innovation and capital allocation while addressing challenges such as fluctuations in public funding. Despite these hurdles, OraSure remains focused on growth through strategic investments and operational efficiencies.

Key Takeaways

• OraSure is celebrating its 25th year as a public company, emphasizing its dedication to innovation and connecting patients to care.
• The company is developing a molecular diagnostics platform, with the CT/NG test expected to become a major revenue driver.
• Strategic acquisitions, such as Sherlock and BioMedomics, are aimed at leveraging existing distribution channels and expanding the international portfolio.
• OraSure is diversifying its customer base and optimizing its product portfolio to mitigate risks from public funding uncertainties.
• Future growth is expected from new product launches in 2026, focusing on diagnostics, sample management, and proteomics.

Financial Results

• Cash position stands at $216 million as of Q3.
• A $40 million share repurchase program is underway, with $5 million repurchased in both Q2 and Q3.
• The core business is currently at break-even cash flow.
• The rapid diagnostics business is expected to generate mid to high $60 million in revenue this year.
• The sample management business is projected to generate high $30 million in revenue for 2025.
• The international business faces slowed momentum due to funding disruptions, with revenue in the low to mid $30 million range.

Operational Updates

• OraSure has implemented cost discipline and operational efficiencies to strengthen its business foundation.
• The company has exited certain cost-negative businesses and is diversifying its customer base.
• Capacity utilization is at 30%, with potential for margin improvement as volume increases.
• The acquisition of BioMedomics is expected to bring in around $1 million in revenue, with potential growth in the coming years.

Future Outlook

• Growth in 2026 is expected from syphilis testing and new product launches, reducing market uncertainties.
• OraSure is focusing on innovation in STIs, liquid biopsy, infectious disease, and proteomics.
• The CT/NG test aims for FDA submission by the end of this year, with a potential launch in mid-2026.
• The company targets 50%+ gross margins as volume increases without additional fixed infrastructure.

Q&A Highlights

• OraSure is aiming to reach break-even as new products launch, potentially by 2027 or 2028.
• Management acknowledged market skepticism but emphasized the focus on innovation and share buybacks as a good return on investment.
• The stock decline is attributed to challenges in the public health space and general investor sentiment towards small-cap healthcare stocks.

For further details, readers are encouraged to refer to the full transcript.

Full transcript - Stephens Annual Investment Conference:

Operator: How's y'all's day going?

Unidentified speaker: Good.

Morning.

Operator: Yeah.

Almost at the halfway point for you, right?

No.

Oh, maybe time-wise, not meeting-wise, maybe.

Yeah, time-wise for sure. Meeting-wise, I think we have seven more.

Should be healthcare mostly today and tomorrow.

Yeah, healthcare is almost all today and tomorrow. I prefer to try and get everybody in on Wednesday because it just seems like you get more generalists. Thursday, people are trying to plan their returns and get back home.

Yeah, that makes for a busy Wednesday, but you get it all knocked out.

Yeah, exactly.

Ken McGrath, Chief Financial Officer, OraSure Technologies: What time are my phones off?

Operator: Hey, George. He asked a lot of his questions this morning.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, all the Miami fans are mad at us.

Operator: Oh, I see.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Because they beat us head-to-head and beat the same record.

Operator: Yeah.

Ken McGrath, Chief Financial Officer, OraSure Technologies: They're all pissed at us.

Operator: Notre Dame seems to get the favorable treatment of being fair, if I'm being honest.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Everyone hates us, Robin. You know what? I'm not going to complain.

Operator: We're not webcasting today, right?

No, we are.

Oh, we are? Okay.

Yeah. Do we just do the microphones or?

Yeah, just speak into the mic. Or you don't have to speak directly into it, but generally speaking. Scares me a bit.

It is. Certainly. They need to turn it on or anything.

We'll give it a few seconds, and then we'll. I wasn't sure. Y'all don't typically webcast, do you?

Ken McGrath, Chief Financial Officer, OraSure Technologies: We wanted to do this one just to have one on record.

Operator: Yeah.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Not do the others.

Operator: Yes.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Do the other ones.

Operator: I appreciate it. Makes me look better.

Ken McGrath, Chief Financial Officer, OraSure Technologies: No, absolutely. We appreciate all of you for doing it. You guys have always been very supportive of us.

Operator: All right, we'll go ahead and get started. Welcome to day two of the Nashville 2025 Stephens Investment Conference. I have the pleasure today to be joined by Ken McGrath, the Chief Financial Officer, and Jason Plagman, the Vice President of Investor Relations over at OraSure. This is more of a fireside chat type of conversation, so feel free to chime in with any questions you may have along the way, and I'll stop and pause along the way too to poll the audience. With that, Ken, I'll turn it over to you for any introductory comments and we'll launch into Q&A.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Thank you. Thank you for hosting us. You guys have done a great job and been very supportive. We appreciate that. We're proud that this is our 25th year of being a public company at OraSure Technologies, and we don't take that lightly. Through that time and through that period, we have leading positions and products in our rapid diagnostic space, in our sample management space that help us connect patients to care, and we're very proud of that and excited about that. What we're very excited about is our near-term product roadmap, and we'll talk, I'm sure, more about this with the acquisition of Sherlock last year. We have a platform in molecular diagnostics that is rapid point-of-care testing that really gets us excited.

The first area that we're looking at is in chlamydia and gonorrhea, which is a large market in the STI space, a $1.5 billion market. In addition to that, we're excited about our ColiP device, of which we've said publicly that we are going to be submitting for FDA approval for STI either later this year or early next year. We are very excited about our long-term innovation pipeline and the spaces that we're looking at, whether it's STIs, whether it's liquid biopsy, whether it's infectious disease. We think that our capabilities and our strategy really align with where healthcare is going, whether it's precision medicine, point-of-need testing, really has us a lot to be excited. That being said, 2025 was a transition year with some of the uncertainty around the government funding, both internationally and in the U.S. We are navigating through that uncertainty.

The good news is that with the structure that we put in place prior to entering 2025, both the cost discipline and the efficiencies that we put in place, as well as building up our cash position, we are able to navigate 2025 while still building out our pipeline and investing in the future. That has us really excited and really excited for 2026.

Operator: Yeah, we'll get to the product roadmap, but maybe to start just from a high level, OraSure's been on a little bit more of quite the journey. You've been streamlining the portfolio, improving operational discipline. Can you just highlight for us what's been accomplished so far and where you're at in that process?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, over the past three or so years, we've kind of focused in a couple of areas. One is really strengthening our foundation. That's getting our core business to break even cash flow, and that's important to us. Any dollars beyond that are really for innovation. It shows what the team has demonstrated around the cost and operational discipline, which is very important. We've developed low-cost manufacturing through our work that we did with the COVID epidemic and the products that we launched and all those capabilities through automation and operational efficiencies. We're able to leverage those in the rest of our pipeline. We've upgraded key talent within the organization, and we've streamlined the portfolio.

There are certain areas and businesses that we felt just didn't either were in a cost-negative position or we didn't think that the market was ready at the time that we made the tough decisions to exit, to really streamline and focus. All while doing that, we've strengthened our balance sheet. That gives us the flexibility to weather any uncertainty, to invest in the future. That's really what you'll hear from us is 2025 was a transition year, some of it a little bit unexpected. We've used the term punched in the nose when it comes to the uncertainty of budget funding, of some of the public budget funding. During that year and during that uncertainty, we were still able to advance our pipeline and invest in the future. That's the credit to the team putting in place.

That's kind of the strengthening part. The other element is around elevating the core of our business, whether it's, again, through operational efficiency, which we strive every day, as well as through diversifying our customer base. One of the elements that people are aware of is that a large portion of our customer base is around public health. When the uncertainty happens, we get disproportionately impacted by that. We have made an effort the last couple of years to diversify into other channels to be less exposed and to be more exposed to other opportunities. The other area then, that's kind of our strengthening the foundation, elevating the core. The third is really accelerating profitable growth. That's really investing in innovation. A question we get asked a lot is, how do you plan on deploying your capital?

The primary focused area is around innovation and really focusing in whether it's in diagnostics, in rapid diagnostics, where we want to have more tests and more pipeline of tests, or sample management where we want more sample types beyond just oral fluid, getting into blood, urine, and other areas, skin and other areas, more analytes, getting into RNA, proteomics, and then more applications, whether it's liquid biopsy, oncology, cardiovascular. Those have been our focus areas. This is all kind of underpinned by strong governance. We have a very strong board. We've gone from 10, and we've refreshed our board over the years. We've gone from 10 members to 7. Six members have departed in that time, but we've added three very strong individuals. Most recently, we added an individual, Steve Boyd, who brings the investor capital markets perspective.

We've added also in the recent years, Jack Kenny, who brings CEO and commercial expertise among other expertise. We have a very strong CFO representation with Bob McMahon, who is the current CFO of West Pharmaceutical, but was a CFO of Agilent and Hologic. We have a really strong among the existing as well as the existing board members. Really strong governance is in place as we move forward.

Operator: We're really happy to have Bob here next or tomorrow.

Ken McGrath, Chief Financial Officer, OraSure Technologies: That's right. Bob's here tomorrow. That's right.

Operator: Well, you've wound down a handful of businesses and divested a few others. What remains within OraSure's portfolio today, and how should we think about the long-term growth potential across those various businesses?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, break it out into kind of our rapid diagnostics part of our business, which right now is in kind of the mid to high $60 million for this year. And think about 30-minute or less test results. Point of care, point of need. Really the focus there is this syndemic approach. For example, we have HCV and HIV. We added through a partnership syphilis test. What it enables you to do is you do kind of that syndemic sale where they're related and you have same types of customers. That allows us to kind of build off of that strength of our channel capabilities. As well as, and we talked about it earlier, is really around diversifying our customer base. Again, public health was and is the largest of our channels.

However, we recognize that we need to diversify from that and expand into other areas. Whether it's an example of that is in healthcare systems. For example, we have a growing business in our HCV and our emergency rooms and other areas. Getting into other channels is really exciting there. That is kind of the rapid diagnostics part of the business. On the sample management, which is in about the high $30 million range for 2025, we have best-in-class devices and chemistries. I really focus on that chemistry as well. We have really great chemistries. We have an FDA-cleared oral fluid collection device. What we are getting into now and expanding is into other sample types. With our ColiP submission for STIs, we are expanding further into urine.

We have collection devices for skin, fecal matter, and then getting into blood with our partnership with Sapphoros and with our products that we've mentioned before, SACEO DOT and SACEO DRAW in the future. We launched a product earlier this year, or I guess mid this year, I say, a blood proteomics, a HemoCollect device. That gets you into the growing proteomics space. It is a really neat device that at ambient temperature stores and stabilizes the chemistry for about 10 days or so. That is really exciting. There are areas there, which really we're excited about the precision medicine potential and what's continuing there, as well as the commercial genetics. We do not think it's a matter of if it will return, it's when it will return. That is what really gets us excited.

We believe our strategies and our capabilities align with where healthcare is going, whether it's point of care, whether it's precision medicine. That's what really excites us about the future.

Operator: More of a closer-to-the-home type of portfolio.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yes, exactly.

Operator: Maybe starting on the diagnostic side, I think there's been some moving pieces globally. Can you just give us a sense of where your end markets stand today? Yeah, that'd be great. We'll just start there.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, we entered 2025 with a lot of momentum. We had one of our strongest years in international. There was some uncertainty that came out during the year. That was changing in public funding levels, both domestically and internationally. The international business, which is in the low to mid $30 million of revenue, we called out that there was going to be a slower pace in the second half of this year, really driven by this uncertainty where there was a disruption to the funding. What was a recognition was after that disruption, there is a recognition of the value of diagnostics and treatment. There was a change in that position where, okay, we are disrupting funding, but now we are going to go back to funding diagnostics and treatment.

What happened in there is the logistic network, the distribution network was disrupted and is still now in that position where it's recovering. During that period, there was a buildup of inventories in local countries, let's say countries in Africa built up inventories, and now they're working through those inventories. We believe they're working through that. We believe that our product, oral fluid, HIV, is the industry leader. We have 10 years of experience and relationships in that space and in that region. We're really excited about that. They are working through it. There are new models being built where countries within Africa are figuring out their own logistics to support the uncertainty. That's kind of the international business. Going into the year we had our highest year, highest revenue.

A little bit of an uncertainty and disruption there. From the U.S. business, probably, again, low to mid $30 million of revenue. The budgetary reductions in the U.S. did introduce some uncertainty. Similar to international, there was some uncertainty around, will we be funded? Because there were questions around the budget. During that uncertainty, there was a little bit of pullback from some of the agencies where they had limited dollars. They wanted to wait until the budget got resolved. What they were doing was really kind of preserving more of the people part of it and holding back on some of the device spend. What we found is that there's still uncertainty, but as it gets lower, there's more openness and more recognition of the value that our products provide. The example there is Together Take Me Home, a really successful program.

Success is measured by finding positive patients. There are studies that show it found twice as much positivity rates than normal channels. That is really important. If you find the patients, you can treat the patients and you reduce the impact of the disease. Through the conversations, there was uncertainty around whether it would be funded. Through bipartisan support and through the current administration, it was recognized the value of a program like that and our device that plays in a program like that. As a result, they continued the funding for year four, going from October to the following October, which is really encouraging. It shows us that, yeah, there is some uncertainty with some of the budget implications. Maybe there is a little throwing out the baby with the bathwater kind of dynamic that plays out there.

We think that the value of our products and what they offer comes to light in the end. As a result, will be funded going forward. The other thing that we play out in the U.S., we continue this syndemic approach in how we sell. I'll say it again, probably said it too many times, but we continue to diversify our channel distribution and customer base.

Operator: Got it. And then just on the Take Me Home together, can you remind me of how much revenue that generated back in or in 2025 thus far, and then how much you expected on a quarterly basis?

It was around $8 million last year, and it'll be a little bit lower this year, but we expect kind of in that similar level going forward.

Okay. Appreciate that. You kind of touched on this, but where do you see the biggest opportunities across HIV, HCV, syphilis testing just moving forward from here?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah. For diagnostics, we really, it's a lot of it is around more tests. What we've done is we've laid out in a recent investor presentation that we put up on our website, we laid out our near-term roadmap around our Sherlock CT/NG product, around our blood proteomics product, which was launched mid-year this year, around our ColiP STI product, which again, both Sherlock and ColiP, we plan on submitting by the end of this year, early next year, and then our SACEO DOT and DRAW. That's kind of our near-term roadmap that we're very excited about. Going forward beyond that, what we laid out is our thought process of how we're looking at future investments. We kind of do an X-axis, Y-axis there.

The Y-axis is around market attractiveness, and then the X-axis is really around our ability to win and compete in that market. The spaces that come out there, things like STI, infectious disease, liquid biopsy, wellness, antimicrobial, there's some spaces there that kind of give you a sense of where we're looking when it comes to either internal or external investments. We're kind of agnostic to organic or inorganic. We just know where we want to play, and then it's just finding where those opportunities are. The good news is our balance sheet has put us in a position where we've never said no to an opportunity because of funding. We have a very rigorous process that has to meet a lot of criteria, and we are very disciplined.

We're not going to jump at opportunities, but we know we have the flexibility if an opportunity presents itself that we can take advantage of it.

Operator: Got it. Touching on part of that product roadmap that you just mentioned, the CT/NG test, you've been more heavily investing in innovation just lately. Can you give us an update of where the CT/NG test stands in the approval process?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, we're very excited about this. This is a big market, right? $1.5 billion market. We said publicly that we think this could be our largest product in revenue in three to five years. It has a molecular point of care test. Again, remember, a disposable molecular point of care test versus the equivalent is I have to send the test out three to five days, get a result. Really groundbreaking technology. We said that we plan to submit by the end of this year, early next year. We're still sticking to that plan. We're very excited. We're very confident. We're excited about the opportunity. As we go forward, what we look at Sherlock, right? We'll have a name for the product and all that beyond that.

What we look at is this is one test in a platform that we can put other tests on, and it's a great platform that delivers molecular results in a disposable, low-cost, rapid manner, which was very exciting.

Operator: Before we touch on that, what do you consider as the near and long-term revenue contribution for market share as the CT/NG test ramps? Is it pretty minuscule, I would assume, in 2026, and then more of a contribution in 2027?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, you can expect if we submit to FDA in the timeframe that we're talking about, imagine FDA takes time to go through their approval process. You could think mid-year of a launch is something we've said publicly that we could expect, and then a ramp-up. Obviously, we want to get all of our ducks in a row so we have a smooth launch and we can ramp up as fast as we can. It takes time, right? A little bit of different channels. We've been talking about more of a business-to-business-to-consumer channel where we can leverage some of those players that I'm sure you're well aware of that have spent significant dollars building that customer relationship and building that interface and that infrastructure. What they want is content.

What we can provide in this particular case and hopefully in future cases is that content that they could then distribute through their channels.

Operator: You mentioned that this is more of a platform type of play. I think in your deck, you highlighted CRISPR detection and ambient temperature amplification as opportunities to commit some more capital to R&D. What is the strategic rationale behind those investments?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, think of them, what they drive is either a lower-cost platform, which is really important, or an improved level of detection. So better quality, better performance, lower cost. For ambient, for example, the current device has a battery in it. That allows you to do the molecular testing and get to the certain temperature. I am butchering this, and all the R&D folks are probably cringing as they hear me say this. What this would allow you to do is, with a certain chemistry and certain enzymes, be able to do it at ambient temperature. Now you can make it a much thinner device, obviously cheaper, and it provides it just for us. In that particular case, it is a low-cost device that really excites us. When you get into CRISPR, it is really about performance and level of detection that you can improve.

Really excited about those. Those are a little bit longer term out, but it shows that this truly is a platform that we want to grow from over the years.

Operator: Just stepping back and looking at that as a whole, it sounds I think originally you said it'd be like $150 per test for the CT/NG. If you're able to further exemplify that portfolio product, it sounds like you can increase margins there over time just as that comes about.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, I think we've said that these would definitely be accretive to our current margins. We're excited about it. Obviously, volume dependent. As you get more volume, you can leverage that. Currently, right now, we're doing it with a contract manufacturer, and there are volume commitments there that we do. Yes, you could see that it would be accretive over time to our margins.

Operator: Awesome. That's fantastic to hear. Backing up a little bit, I think you just announced the acquisition of BioMedomics. I think this is expanding into rapid sickle cell testing, which is more of an international type of test. What attracted you to that business, and how do you see it scaling internationally?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, this is an example of we're also opportunistic. Our international folks saw this test, and we're excited about it. Right price point, great quality. We talk about what's the best way to do it. Do you partner? Do you distribute? Do you acquire? In this particular case, there was an opportunity to acquire. We think for the right amount of dollars. Is this the end-all, be-all? No. It is a nice tuck-in acquisition. It goes through our existing distribution channels where we have great relationships, so we can leverage that, and we can accelerate the growth from there. It's mostly Africa, Latin America type regions that we're dealing with. It goes right with the same conversations we're having with HIV and HCV that now we can sell this along. In the U.S., not as much of a need. The focus was international.

Is this the last thing we'd ever do? No. It was a nice little tuck-in that we liked. Think of it as adding another product to the bag for the salespeople. As they go and make a conversation, they can bring this one up as well. Right now, it's about $1 million in revenue, and we think it can grow from there to a couple of million dollars.

Operator: Okay. What's the timeframe on that? Is it a couple of years?

Ken McGrath, Chief Financial Officer, OraSure Technologies: A couple of years. Yeah. We are excited about this. One, we have talked about these sometimes in the past, the gross margins may be a little bit lower, but there is, I say zero being dramatic, but very limited operating expenses that need to be added. You are literally just adding the product to our bag, and you can go sell. The bottom line margins are pretty accretive.

Operator: Leveraging the existing channels.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Exactly. You will hear a lot about that from us, whether operational, whether it's our OpEx, it's really leveraging. It's all about getting the volume through the pipeline. As a comparison, in the last 25 years, we've had three products. We want to get in a rhythm where we're doing that on a regular basis every year. What that does is as you bring in the volume, and the conversations we always have with potential partners is, can we manufacture in-house? We've done that effort where we've kind of consolidated into our capacity in Bethlehem. Within Bethlehem, we've brought in from Thailand because it's automated and it's actually cheaper to do it in Bethlehem than in Thailand, which was more manual. We've brought in work from our contract manufacturers in Canada into Bethlehem as well.

It is really filling the factory in that particular case model, leveraging our fixed infrastructure. As you add the volume, you can imagine the margins go up a little bit exponentially because you do not have to add any fixed infrastructure to support that.

Operator: Makes sense. Before we get to margins, I want to turn it over to the sample management portion of the business. Just historically, this was mostly driven by a large ancestry customer, but you've announced a number of partnerships over the recent years. How should we think about the latter driving growth in the coming years?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, so that large customer, we always think of Voldemort, right? Yeah. May not be named. Genetics company that went through bankruptcy. If you exclude that customer, we actually are about flat to growth of the overall business in 2025. Again, it's excluding your bad, your good, right? That kind of thing. I think it's an important data point that the rest of the business we think is fairly healthy. The customers where recently we've done some renewals or expansions are some of the big partners you're aware of: GeneDx, Myriad, Fulgent, Exact Sciences. We're really excited about that. We believe that the product that we offer is a best-in-class product as well as best-in-class chemistries. Around the revenue that we're dealing with this year in the high $30 million for that book of business.

As science advances, we believe our products are positioned to go along with that advancement. There are also some international opportunities that we are seeing potentially in the Middle East for population health type opportunities that are interesting.

Operator: Interesting. You mentioned on the three-year call that you expect SMS to return to growth in 2026. What gives you confidence in that outlook?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, overall for the whole, not just sample management, whole business, we're seeing good, we're seeing some solid growth in our syphilis testing. We think the uncertainty is becoming lower overall. Individuals, our customers are navigating that, and we're helping them navigate that. We think there'll be some return to growth in those areas. We're excited about our new products, and we think that'll be one of the drivers of our growth. That'll be mid-year to the second half of the year as we launch those, but we think those will help us towards a growth for the full year in 2026.

Operator: You've already highlighted a lot of them, but just looking at the product roadmap for SMS, what do you think are the greatest areas for near-term and long-term opportunities?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, near-term, ColiP. ColiP, STI, we're very excited about that opportunity. We think it offers a less invasive at-home collection option for patients and for customers. So we're really excited about that. In the future, I sound redundant here, and I apologize, but it's really about more sample types. Again, think blood, SACEO DOT, SACEO DRAW. Think urine as we expand with ColiP. And then it's more analytes. As we get into proteomics in that space as we launched our product mid this year. Then it's more use cases. We get into liquid biopsy, oncology, cardiovascular. As those applications grow, we think we're positioned to support that growth.

Operator: Got it. And then looking at ColiP and the proteomics product sample types that you're moving into, ColiP is obviously a near-term opportunity, but I think it's a smaller TAM. And then you see blood as the larger opportunity, but it's probably a little bit more longer dated.

Ken McGrath, Chief Financial Officer, OraSure Technologies: We're still excited. ColiP, we think even beyond STIs, gets into HPV and other areas. That self-collection, less invasive, is a really big point. Our chemistries, we talk a lot about devices, but our chemistries are best in class. Especially some of our chemistries are non-toxic, which is a big thing when you're dealing with at-home collection, really offer best-in-class solutions. To your point, blood. Obviously, blood's a big part of the market, sample type market. Our play into that with SACEO DOT and SACEO DRAW are very exciting.

Operator: Got it. And HemoCollect, it's RUO currently, but is it a relatively small portion of the portfolio at this point?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Relatively small. As proteomics grows, and we believe that we're positioned there where it's a room temperature collection and stabilization for up to 10 days, that's pretty—what it does is for certain companies, it eliminates the cold chain need. Now, some companies already have the cold chain in place. For other companies, it eliminates that cold chain need. Getting up to speed is a lot easier using that collection device.

Unidentified speaker: I'd just add on the proteomics space. We see that that's a kind of burgeoning space, a lot of very interesting research going on. We want to establish a leadership position there for the next decade or more. For right now, we're entering the market, and we're excited about it. That's a long-term growth opportunity, I think, more so than in the short term. It'll contribute certainly to growth, but we're really excited about the long term as kind of the scientific and technological breakthroughs occur in the proteomics space. We think that can kind of be like genetics and DNA testing were 10, 20 years ago. We think proteomics is kind of at a stage, and we want to establish that leadership position there.

Operator: Got it. Appreciate it, Colin, there.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Thank you.

Operator: I'll just stop here for a second and see if anybody has any questions before we move on.

When do you think you get to break even?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, so our core business is break even right now. Any dollars that we spend are on innovation. We could at any moment pull that trigger if we wanted to. We have demonstrated in the past that we're willing to make those tough decisions to adjust our cost structure as needed. We believe that now these investments and the return on invested capital from those investments are sufficient enough to encourage us and to want us to make those investments. Overall, you could think of it we haven't guided, but you can think of as you do the launches of our new products in the second half of the year, you could imagine that's going to start getting us closer and closer to that point.

Given the investment you're making, do you think by 2027 or 2028, you'll be at kind of a break even?

Operator: Just to repeat the question.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Oh, the question, I apologize. Yeah, no microphone, sorry. Yeah, the question is, when do we think we'll be break even? And do we think, based on the investments and then the new product launches, is 2027, 2028 a reasonable thought process? I think that's a reasonable way to think of it.

I'm not, I literally came here because where your stock is. How much cash do you have?

216 million.

You're sitting here with an EV of minus $50 million. Basically, the market is saying that what you're investing in, they do not believe in or no one cares.

Correct.

Okay. Do you buy back stock or do any of that or?

Yep. I'll repeat what you're saying just so people hear it. Is that fair?

Operator: Yeah, yeah. The question was.

Ken McGrath, Chief Financial Officer, OraSure Technologies: The question that we're getting is.

No, no, for the recording.

Yeah, no worries. The question being asked is around our cash balance position and the uses of that cash. We have $216 million of cash as of Q3. Your point about right now, when you look at our enterprise value as negative enterprise value, how are investors thinking of our current business? Let me talk about the cash usage and how we think about cash. The way we think about capital allocation deployment, we think of a balanced approach, but our number one priority is innovation. We believe in investing in innovation where there's a strong return on invested capital. However, at the current share price, we believe that the math has changed a little bit when it comes to share repurchase, and we believe there is a good return on invested capital in buying back our share.

What we did earlier this year is we announced a $40 million share buyback program over two years, $5 million, roughly a quarter. In the first Q2 and Q3, we did $5 million each quarter, $5 million each quarter. We could obviously always change that amount based on where we're investing and needs, but that's what we've announced. It's less of a, it's more of a recognition of the price and where the price is, and we believe it's a good return on invested capital. Our number one priority, and I just want to say it again, our number one priority is on investing in innovation. We're agnostic to organic or inorganic. We've done both, whether it's internal innovation with chemistries that we invested in or whether it's partnerships we've done with Sherlock and with BioMedomics.

One last question.

Yeah.

Was there something recently in the last three or four months that you said that basically got the stock to go in half, 12-15%, or is it just slowly just declining out of its own because it's declining? I mean, was there a negative announcement?

No.

Operator: There was no negative announcement.

Unidentified speaker: There wasn't any specific announcement. I mean, the challenges with the public health space of kind of pressures on legacy.

Healthcare stocks are. Basically, it's a confluence of events where people don't like small cap, don't like micro cap, don't like healthcare, but there was nothing that was announced or no frustration.

Ken McGrath, Chief Financial Officer, OraSure Technologies: No. What we've talked about for 2026 as far as catalysts, it's really our near-term roadmap, right? It's around product launches. What we've said publicly is that for CT/NG, our Sherlock molecular device, and for ColiP for STIs, we are going to submit to FDA by the end of this year or early next year.

Operator: Following up on his profitable growth questions, COVID became a significant part of the story a few years ago. It's obviously a much smaller piece of the business now. What lessons ultimately did you take from the company, or did the company take away from that period, and how has it helped shape your operations' profitability today?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, so COVID did a couple of things. One is it allowed us, with government investment, to build out a capacity and automation that we can leverage now. It allowed us to demonstrate how to do high volume, which we have the capability to do now, and to do it at low cost with low scrap rates, etc. That is what we are leveraging now. That capability, we are leveraging on our current platforms as we continue. Right now, we have said publicly that we are operating at about 30% capacity. As you can imagine, as we add volume, we are not adding that fixed infrastructure. Margins can then grow from there.

The other thing we did with COVID and with that capacity is we insourced a lot of our contract manufacturing, both from Thailand and Canada, to take advantage of that capacity and insource some of the chemistries and things that we were outsourcing prior. We did that. Really, it's about a lesson in that particular case around the automation and the rigor that was necessary to deliver those level volumes and now applying that capability onto our existing platforms. The other thing it did just financially is it built up a cash balance that we are able now to deploy into the pipeline and grow our pipeline. Again, we did in 25 years, we had three products that we developed. Now we're trying to do that on an annual basis.

Operator: That's excellent to hear. I think you also, because of this, you pointed towards 50% plus gross margins in the out years. What are the main levers that you need to pull to get there?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah, there's the normal stuff you do every day, right? The operation, we tell our ops team, you're going to grow X% of efficiency every year for the rest of your lives. That's never going to change. That's automation, that's procurement savings, all the normal things that you would do. There was the big streamlining of the footprint where we, again, consolidated our manufacturing. The next step is really volume. That's why we're talking about our pipeline revenue growth launches in the upcoming year. As you get the volume, I said it again, but I'm going to say it again because it's really important. As you get more volume, you don't have to add incremental fixed infrastructure. The math just says that your margins should grow from there in an exponential manner.

Operator: I think part of this equation has also been on operating expenses. You've done a pretty good job of maintaining the cost, but you're also investing in the CT/NG test, which is, I think, $7 million a quarter.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Yeah. The majority of that is the clinical trial.

Operator: Correct. From here, would investors consider 3Q operating expenses and gross margins a good baseline moving forward?

Ken McGrath, Chief Financial Officer, OraSure Technologies: I think it's a good baseline. The one thing we've said that ebbs and flows is that innovation spend. Again, we've tried to be break even with our OpEx expense at this current revenue level for the core business. The incremental is innovation, that other $10 million we always talk about. That's internal innovation as well as the majority of it is Sherlock, and the majority of that is the clinical trial. You can imagine that clinical trial can ebb and flow as we kind of wind down the CT/NG trial, and then we want to start the next one. There's some timing there of spend differences. We want to get a natural rhythm where as one kind of winds down, we are getting ready and launching up the next one.

Operator: This may be a bit early, but the $7 million correlates been on that trial. Once that's completed, do you expect to spend roughly the same amount on?

Ken McGrath, Chief Financial Officer, OraSure Technologies: That's the part that's the ebb and flowing that I'm talking about. That's the part that will up and down. We have a pipeline of next opportunities that we want to get going, but you don't start those instantly. That's the part where the timing of when we start those and get those going. We don't have the capacity to do multiple in parallel, but we do have the capacity to do it more in serial, and that's what we're looking at.

Operator: Got it. How do you balance the reinvestment for growth in diagnostics and sample management versus driving profitability from here?

Ken McGrath, Chief Financial Officer, OraSure Technologies: It's really a balanced approach. It's a balanced approach of what's the return on invested capital of those opportunities? If we have strong return on invested capital, then we will make those investments to grow because you do get that kind of amplifying effect of as we get that more volume and get more growth, the margins improve, you leverage your existing infrastructure. We are looking right now, it's innovation and growth. Profitable growth is what we're looking for. We have enough very strong return on invested capital opportunities that we're going to continue to invest.

Operator: Right. You mentioned the $216 million of cash. Just how are you thinking about capital allocation from here?

Ken McGrath, Chief Financial Officer, OraSure Technologies: Innovation is the first word. That's our number one deployment. Share repurchase, again, we talked about it earlier. The math changed with the share price, and it's just a reflection of that's a good return on invested capital in our mind. Innovation is the number one thing. Innovation, both organically and inorganically. We're agnostic to how we get the innovation. We look at all avenues, and we've demonstrated that. We've invested internally, whether it's the new blood proteomics chemistries and device, or whether it's externally with BioMedomics or the partnership with Sherlock. We believe we have taken a very rational approach in our acquisition type deal structures. Sherlock, for example, was a small upfront, milestones upon success, and then royalties after that revenue growth. We believe we've taken a very prudent approach to that as we deploy our capital.

Operator: Got it. As you look out over the next three to five years, what do you see as the biggest growth engines? Separately, as we wrap up, what do you think is the most misunderstood thing about where OraSure stands today and the opportunities in front of you?

Ken McGrath, Chief Financial Officer, OraSure Technologies: It's really that innovation kind of quadrant that we talked about earlier, where we look at the market attractiveness and our ability to win. The areas that jump out, again, STIs jumps out for us because it's the privacy, the point of care, all those elements, the rapid results, things like that. Liquid biopsy is an area that really excites us. Infectious disease are areas that excite us, whether it's viral, bacterial. Wellness is an area that's interesting when you think about a diversified customer base where it's less about public funding and more about consumer spend. Antimicrobial is an area. These are areas that we're looking at, kind of where we do our fishing when it comes to deploying our capital. We have to match the area, the opportunity with what exists, but that's how we're looking at it.

Operator: Got it. I think we'll leave it there. Ken, Jason, I appreciate you all for joining us.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Thank you very much, Mac.

Operator: Thank you.

Ken McGrath, Chief Financial Officer, OraSure Technologies: Appreciate it.

Operator: Thank you.

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