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ORASURE TECHNOLOGIES INC — Call Transcript 2025
Nov 19, 2025
How's y'all's day going? Good. Morning. 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. What time are my phones off? Hey, George. He asked a lot of his questions this morning. Yeah, all the Miami fans are mad at us. Oh, I see. Because they beat us head-to-head and beat the same record. Yeah. They're all pissed at us. Notre Dame seems to get the favorable treatment of being fair, if I'm being honest. Everyone hates us, Robin. You know what? I'm not going to complain. 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? We wanted to do this one just to have one on record. Yeah. Not do the others. Yes. Do the other ones. I appreciate it. Makes me look better. No, absolutely. We appreciate all of you for doing it. You guys have always been very supportive of us. 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. 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 Colli-Pee 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. 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? 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. We're really happy to have Bob here next or tomorrow. That's right. Bob's here tomorrow. That's right. 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? 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 Colli-Pee 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 Sapphiros and with our products that we've mentioned before, SatioDot and SatioDraw 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. More of a closer-to-the-home type of portfolio. Yes, exactly. 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. 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 TakeMeHome, 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. Got it. And then just on the TakeMeHome 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? 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's CT/NG product, around our blood proteomics product, which was launched mid-year this year, around our Colli-Pee STI product, which again, both Sherlock and Colli-Pee, we plan on submitting by the end of this year, early next year, and then our SatioDot 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. 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? 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. 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? 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. 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? 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. 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. 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. 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? 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. Okay. What's the timeframe on that? Is it a couple of years? 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. Leveraging the existing channels. 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. 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? 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. 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? 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. 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? Yeah, near-term, Colli-Pee. Colli-Pee, 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, SatioDot, SatioDraw. Think urine as we expand with Colli-Pee. 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. Got it. And then looking at Colli-Pee and the proteomics product sample types that you're moving into, Colli-Pee 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. We're still excited. Colli-Pee, 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 SatioDot and SatioDraw are very exciting. Got it. And HemoCollect, it's RUO currently, but is it a relatively small portion of the portfolio at this point? 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. 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. Got it. Appreciate it, all you there. Thank you. 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? 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? Just to repeat the question. 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 -$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? Yeah, yeah. The question was. 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, [audio distortion] or is it just slowly just declining out of its own because it's declining? I mean, was there a negative announcement? No. There was no negative announcement. 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. 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 Colli-Pee for STIs, we are going to submit to FDA by the end of this year or early next year. 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? 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. 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? 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. 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. Yeah. The majority of that is the clinical trial. Correct. From here, would investors consider 3Q operating expenses and gross margins a good baseline moving forward? 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. 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? 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. Got it. How do you balance the reinvestment for growth in diagnostics and sample management versus driving profitability from here? 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. Right. You mentioned the $216 million of cash. Just how are you thinking about capital allocation from here? 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. 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? 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. Got it. I think we'll leave it there. Ken, Jason, I appreciate you all for joining us. Thank you very much, Mac. Thank you. Appreciate it. Thank you.
Speaker 4: How's y'all's day going? How's y'all's day going? how's y'all's day going
Speaker 2: Good. Good. good Morning. Morning. morning Yeah. Yeah. yeah
Speaker 3: Almost at the halfway point for you, right? Almost at the halfway point for you, right? almost at the halfway point for you right No. No. no Oh, maybe time-wise, not meeting-wise, maybe. Oh, maybe time-wise, not meeting-wise, maybe. oh maybe time-wise not meeting-wise maybe Yeah, time-wise for sure. Meeting-wise, I think we have seven more. Yeah, time-wise for sure. yeah time-wise for sure Meeting-wise, I think we have seven more. meeting-wise i think we have seven more Should be healthcare mostly today and tomorrow. Should be healthcare mostly today and tomorrow. 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, healthcare is almost all 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. 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. 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, that makes for a busy Wednesday, but you get it all knocked out. yeah that makes for a busy wednesday but you get it all knocked out Yeah, exactly. Yeah, exactly. yeah exactly
Speaker 2: What time are my phones off? Hey, George. He asked a lot of his questions this morning. What time are my phones off? what time are my phones off Hey, George. hey george He asked a lot of his questions this morning. he asked a lot of his questions this morning Yeah, all the Miami fans are mad at us. Yeah, all the Miami fans are mad at us. yeah all the miami fans are mad at us Oh, I see. Oh, I see. oh i see Because they beat us head-to-head and beat the same record. Because they beat us head-to-head and beat the same record. because they beat us head-to-head and beat the same record Yeah. Yeah. yeah They're all pissed at us. They're all pissed at us. they're all pissed at us Notre Dame seems to get the favorable treatment of being fair, if I'm being honest. Notre Dame seems to get the favorable treatment of being fair, if I'm being honest. notre dame seems to get the favorable treatment of being fair if i'm being honest Everyone hates us, Robin. You know what? I'm not going to complain. Everyone hates us, Robin. everyone hates us robin You know what? you know what I'm not going to complain. i'm not going to complain We're not webcasting today, right? We're not webcasting today, right? we're not webcasting today right
Speaker 3: No, we are. No, we are. no we are Oh, we are? Okay. Oh, we are? oh we are Okay. okay Yeah. Do we just do the microphones or? Yeah. yeah Do we just do the microphones or? 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. Yeah, just speak into the mic. yeah just speak into the mic Or you don't have to speak directly into it, but generally speaking. or you don't have to speak directly into it but generally speaking
Speaker 2: Scares me a bit. Scares me a bit. scares me a bit
Speaker 3: It is. Certainly. They need to turn it on or anything. It is. it is Certainly. certainly They need to turn it on or anything. 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? We'll give it a few seconds, and then we'll. we'll give it a few seconds and then we'll I wasn't sure. i wasn't sure Y'all don't typically webcast, do you? y'all don't typically webcast do you
Speaker 2: We wanted to do this one just to have one on record. We wanted to do this one just to have one on record. we wanted to do this one just to have one on record Yeah. Yeah. yeah Not do the others. Not do the others. not do the others Yes. Yes. yes Do the other ones. Do the other ones. do the other ones I appreciate it. Makes me look better. I appreciate it. i appreciate it Makes me look better. makes me look better No, absolutely. We appreciate all of you for doing it. You guys have always been very supportive of us. No, absolutely. no absolutely We appreciate all of you for doing it. we appreciate all of you for doing it You guys have always been very supportive of us. you guys have always been very supportive of us 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. All right, we'll go ahead and get started. all right we'll go ahead and get started Welcome to day two of the Nashville 2025 Stephens Investment Conference. welcome to day two of the nashville 2025 stephens investment conference i 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. 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. 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. with that ken i'll turn it over to you for any introductory comments and we'll launch into q&a 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. Thank you. thank you Thank you for hosting us. thank you for hosting us You guys have done a great job and been very supportive. you guys have done a great job and been very supportive We appreciate that. 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. 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. 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. 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. 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 Colli-Pee 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 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. 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 Colli-Pee 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. in addition to that we're excited about our colli-pee 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 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. 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.. 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. 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. 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. 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. that has us really excited and really excited for 2026 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? 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. 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. 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? can you just highlight for us what's been accomplished so far and where you're at in that process 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. Yeah, over the past three or so years, we've kind of focused in a couple of areas. yeah over the past three or so years we've kind of focused in a couple of areas One is really strengthening our foundation. one is really strengthening our foundation That's getting our core business to break even cash flow, and that's important to us. 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. 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. 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'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'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. 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. 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. 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. 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 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. 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. 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. 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 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? That's kind of the strengthening part. 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. 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. 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. 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. 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 other area then that's kind of our strengthening the foundation elevating the core The third is really accelerating profitable growth. the third is really accelerating profitable growth That's really investing in innovation. that's really investing in innovation A question we get asked a lot is, how do you plan on deploying your capital? 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. 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. 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. those have been our focus areas This is all kind of underpinned by strong governance. this is all kind of underpinned by strong governance We have a very strong board. 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 and we've refreshed our board over the years We've gone from 10 members to 7. we've gone from 10 members to 7 Six members have departed in that time, but we've added three very strong individuals. 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. 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. We've added also in the recent years, Jack Kenny, who brings CEO and commercial expertise among other expertise. 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 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. 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. really strong governance is in place as we move forward We're really happy to have Bob here next or tomorrow. We're really happy to have Bob here next or tomorrow. we're really happy to have bob here next or tomorrow That's right. Bob's here tomorrow. That's right. That's right. that's right Bob's here tomorrow. bob's here tomorrow That's right. that's right 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? Well, you've wound down a handful of businesses and divested a few others. 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? what remains within orasure's portfolio today and how should we think about the long-term growth potential across those various businesses 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. 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. 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. and think about 30-minute or less test results Point of care, point of need. point of care point of need Really the focus there is this syndemic approach. really the focus there is this syndemic approach For example, we have HCV and HIV. for example we have hcv and hiv We added through a partnership syphilis test. 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. 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. 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. 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. 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 Colli-Pee submission for STIs, we are expanding further into urine. However, we recognize that we need to diversify from that and expand into other areas. 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. 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. 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. 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. 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. i really focus on that chemistry as well We have really great chemistries. we have really great chemistries We have an FDA-cleared oral fluid collection device. we have an fda-cleared oral fluid collection device What we are getting into now and expanding is into other sample types. what we are getting into now and expanding is into other sample types With our Colli-Pee submission for STIs, we are expanding further into urine. with our colli-pee 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 Sapphiros and with our products that we've mentioned before, SatioDot and SatioDraw 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 have collection devices for skin, fecal matter, and then getting into blood with our partnership with Sapphiros and with our products that we've mentioned before, SatioDot and SatioDraw in the future. we have collection devices for skin fecal matter and then getting into blood with our partnership with sapphiros and with our products that we've mentioned before satiodot and satiodraw in the future We launched a product earlier this year, or I guess mid this year, I say, a blood proteomics, a HemoCollect device. 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. 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. 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. 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. 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. 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. 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. We believe our strategies and our capabilities align with where healthcare is going, whether it's point of care, whether it's precision medicine. 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. that's what really excites us about the future More of a closer-to-the-home type of portfolio. More of a closer-to-the-home type of portfolio. more of a closer-to-the-home type of portfolio Yes, exactly. Yes, exactly. yes exactly 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. Maybe starting on the diagnostic side, I think there's been some moving pieces globally. 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? can you just give us a sense of where your end markets stand today Yeah, that'd be great. yeah that'd be great We'll just start there. we'll just start there 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. Yeah, we entered 2025 with a lot of momentum. yeah we entered 2025 with a lot of momentum We had one of our strongest years in international. we had one of our strongest years in international There was some uncertainty that came out during the year. there was some uncertainty that came out during the year That was changing in public funding levels, both domestically and internationally. 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. 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. 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. 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. What happened in there is the logistic network, the distribution network was disrupted and is still now in that position where it's recovering. 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. 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 they're working through that We believe that our product, oral fluid, HIV, is the industry leader. 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 have 10 years of experience and relationships in that space and in that region We're really excited about that. we're really excited about that They are working through it. 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. 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. that's kind of the international business Going into the year we had our highest year, highest revenue. 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 TakeMeHome, a really successful program. A little bit of an uncertainty and disruption there. a little bit of an uncertainty and disruption there From the U.S. business, probably, again, low to mid $30 million of revenue. 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. the budgetary reductions in the u.s did introduce some uncertainty Similar to international, there was some uncertainty around, will we be funded? similar to international there was some uncertainty around will we be funded Because there were questions around the budget. 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. 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. 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 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. 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 TakeMeHome, a really successful program. the example there is together takemehome 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. Success is measured by finding positive patients. success is measured by finding positive patients There are studies that show it found twice as much positivity rates than normal channels. there are studies that show it found twice as much positivity rates than normal channels That is really important. that is really important If you find the patients, you can treat the patients and you reduce the impact of the disease. 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 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. 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. 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. 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. 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. We think that the value of our products and what they offer comes to light in the end. 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. 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. 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. i'll say it again probably said it too many times but we continue to diversify our channel distribution and customer base Got it. And then just on the TakeMeHome 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? Got it. 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? 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
Speaker 3: 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. 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. 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? Okay. okay Appreciate that. 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? you kind of touched on this but where do you see the biggest opportunities across hiv hcv syphilis testing just moving forward from here
Speaker 2: 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's CT/NG product, around our blood proteomics product, which was launched mid-year this year, around our Colli-Pee STI product, which again, both Sherlock and Colli-Pee, we plan on submitting by the end of this year, early next year, and then our SatioDot 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. Yeah. yeah For diagnostics, we really, it's a lot of it is around more tests. 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's CT/NG product, around our blood proteomics product, which was launched mid-year this year, around our Colli-Pee STI product, which again, both Sherlock and Colli-Pee, we plan on submitting by the end of this year, early next year, and then our SatioDot and Draw. 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's ct/ng product around our blood proteomics product which was launched mid-year this year around our colli-pee sti product which again both sherlock and colli-pee we plan on submitting by the end of this year early next year and then our satiodot and draw That's kind of our near-term roadmap that we're very excited about. 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. 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. 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. 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 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. 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'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. 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. 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 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. 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. 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 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? Got it. 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. 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? can you give us an update of where the ct/ng test stands in the approval process 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. Yeah, we're very excited about this. yeah we're very excited about this This is a big market, right? $1.5 billion market. 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. 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. 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. 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. really groundbreaking technology We said that we plan to submit by the end of this year, early next year. 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 still sticking to that plan We're very excited. we're very excited We're very confident. we're very confident We're excited about the opportunity. we're excited about the opportunity As we go forward, what we look at Sherlock, right? as we go forward what we look at sherlock right We'll have a name for the product and all that beyond that. 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. 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. 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 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? 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? 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? is it pretty minuscule i would assume in 2026 and then more of a contribution in 2027 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. 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. 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. 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. 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? it takes time right A little bit of different channels. 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. 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 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. What we can provide in this particular case and hopefully in future cases is that content that they could then distribute through their channels. what we can provide in this particular case and hopefully in future cases is that content that they could then distribute through their channels 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? You mentioned that this is more of a platform type of play. 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. 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? what is the strategic rationale behind those investments 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. Yeah, think of them, what they drive is either a lower-cost platform, which is really important, or an improved level of detection. 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. so better quality better performance lower cost For ambient, for example, the current device has a battery in it. 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. 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. 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. 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. 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. 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. 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. Really excited about those. 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. 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 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. 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. 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. 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 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. Yeah, I think we've said that these would definitely be accretive to our current margins. yeah i think we've said that these would definitely be accretive to our current margins We're excited about it. we're excited about it Obviously, volume dependent. obviously volume dependent As you get more volume, you can leverage that. 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. 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. yes you could see that it would be accretive over time to our margins 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? Awesome. awesome That's fantastic to hear. that's fantastic to hear Backing up a little bit, I think you just announced the acquisition of BioMedomics. 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. 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? what attracted you to that business and how do you see it scaling internationally 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. Yeah, this is an example of we're also opportunistic. yeah this is an example of we're also opportunistic Our international folks saw this test, and we're excited about it. our international folks saw this test and we're excited about it Right price point, great quality. right price point great quality We talk about what's the best way to do it. we talk about what's the best way to do it Do you partner? do you partner Do you distribute? do you distribute Do you acquire? do you acquire In this particular case, there was an opportunity to acquire. in this particular case there was an opportunity to acquire We think for the right amount of dollars. we think for the right amount of dollars Is this the end-all, be-all? is this the end-all be-all No. no It is a nice tuck-in acquisition. 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 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'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. 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. in the u.s not as much of a need The focus was international. 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. Is this the last thing we'd ever do? is this the last thing we'd ever do No. no It was a nice little tuck-in that we liked. it was a nice little tuck-in that we liked Think of it as adding another product to the bag for the salespeople. 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. 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. right now it's about $1 million in revenue and we think it can grow from there to a couple of million dollars Okay. What's the timeframe on that? Is it a couple of years? Okay. okay What's the timeframe on that? what's the timeframe on that Is it a couple of years? is it a couple of years 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. A couple of years. a couple of years Yeah. yeah We are excited about this. 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. 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. you are literally just adding the product to our bag and you can go sell The bottom line margins are pretty accretive. the bottom line margins are pretty accretive Leveraging the existing channels. Leveraging the existing channels. leveraging the existing channels 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. Exactly. exactly You will hear a lot about that from us, whether operational, whether it's our OpEx, it's really leveraging. 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. it's all about getting the volume through the pipeline As a comparison, in the last 25 years, we've had three products. 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. 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? 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. 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. 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. 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. It is really filling the factory in that particular case model, leveraging our fixed infrastructure. 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. 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 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? Makes sense. makes sense Before we get to margins, I want to turn it over to the sample management portion of the business. 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. 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? how should we think about the latter driving growth in the coming years 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. Yeah, so that large customer, we always think of Voldemort, right? yeah so that large customer we always think of voldemort right Yeah. yeah May not be named. may not be named Genetics company that went through bankruptcy. genetics company that went through bankruptcy If you exclude that customer, we actually are about flat to growth of the overall business in 2025. 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? again it's excluding your bad your good right That kind of thing. that kind of thing I think it's an important data point that the rest of the business we think is fairly healthy. 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. 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'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. 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. 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. As science advances, we believe our products are positioned to go along with that advancement. 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. there are also some international opportunities that we are seeing potentially in the middle east for population health type opportunities that are interesting 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? Interesting. interesting You mentioned on the three-year call that you expect SMS to return to growth in 2026. you mentioned on the three-year call that you expect sms to return to growth in 2026 What gives you confidence in that outlook? what gives you confidence in that outlook 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. 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. 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. we think the uncertainty is becoming lower overall Individuals, our customers are navigating that, and we're helping them navigate that. 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 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. 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. 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 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? 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? 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 Yeah, near-term, Colli-Pee. Colli-Pee, 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, SatioDot, SatioDraw. Think urine as we expand with Colli-Pee. 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. Yeah, near-term, Colli-Pee. yeah near-term colli-pee Colli-Pee, STI, we're very excited about that opportunity. colli-pee sti we're very excited about that opportunity We think it offers a less invasive at-home collection option for patients and for customers. we think it offers a less invasive at-home collection option for patients and for customers So we're really excited about that. 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. in the future i sound redundant here and i apologize but it's really about more sample types Again, think blood, SatioDot, SatioDraw. again think blood satiodot satiodraw Think urine as we expand with Colli-Pee. think urine as we expand with colli-pee And then it's more analytes. and then it's more analytes As we get into proteomics in that space as we launched our product mid this year. as we get into proteomics in that space as we launched our product mid this year Then it's more use cases. then it's more use cases We get into liquid biopsy, oncology, cardiovascular. we get into liquid biopsy oncology cardiovascular As those applications grow, we think we're positioned to support that growth. as those applications grow we think we're positioned to support that growth Got it. And then looking at Colli-Pee and the proteomics product sample types that you're moving into, Colli-Pee 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. Got it. got it And then looking at Colli-Pee and the proteomics product sample types that you're moving into, Colli-Pee is obviously a near-term opportunity, but I think it's a smaller TAM. and then looking at colli-pee and the proteomics product sample types that you're moving into colli-pee 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. and then you see blood as the larger opportunity but it's probably a little bit more longer dated We're still excited. Colli-Pee, 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 SatioDot and SatioDraw are very exciting. We're still excited. we're still excited Colli-Pee, we think even beyond STIs, gets into HPV and other areas. colli-pee we think even beyond stis gets into hpv and other areas That self-collection, less invasive, is a really big point. 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. 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. 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. to your point blood Obviously, blood's a big part of the market, sample type market. obviously blood's a big part of the market sample type market Our play into that with SatioDot and SatioDraw are very exciting. our play into that with satiodot and satiodraw are very exciting Got it. And HemoCollect, it's RUO currently, but is it a relatively small portion of the portfolio at this point? Got it. got it And HemoCollect, it's RUO currently, but is it a relatively small portion of the portfolio at this point? and hemocollect it's ruo currently but is it a relatively small portion of the portfolio at this point 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. Relatively small. 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. 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. now some companies already have the cold chain in place For other companies, it eliminates that cold chain need. for other companies it eliminates that cold chain need Getting up to speed is a lot easier using that collection device. getting up to speed is a lot easier using that collection device
Speaker 3: 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. I'd just add on the proteomics space. 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 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. 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. 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. 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. 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 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. we think proteomics is kind of at a stage and we want to establish that leadership position there Got it. Appreciate it, all you there. Got it. got it Appreciate it, all you there. appreciate it all you there
Speaker 2: Thank you. Thank you. thank you I'll just stop here for a second and see if anybody has any questions before we move on. I'll just stop here for a second and see if anybody has any questions before we move on. 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? When do you think you get to break even? when do you think you get to break even 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. Yeah, so our core business is break even right now. yeah so our core business is break even right now Any dollars that we spend are on innovation. any dollars that we spend are on innovation We could at any moment pull that trigger if we wanted to. 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 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. 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. 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? Given the investment you're making, do you think by 2027 or 2028, you'll be at kind of a break even? given the investment you're making do you think by 2027 or 2028 you'll be at kind of a break even Just to repeat the question. Just to repeat the question. just to repeat the question 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. Oh, the question, I apologize. oh the question i apologize Yeah, no microphone, sorry. yeah no microphone sorry Yeah, the question is, when do we think we'll be break even? 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? 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 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? I'm not, I literally came here because where your stock is. i'm not i literally came here because where your stock is How much cash do you have? how much cash do you have $216 million. $216 million. $216 million You're sitting here with an EV of -$50 million. Basically, the market is saying that what you're investing in, they do not believe in or no one cares. You're sitting here with an EV of - $50 million. you're sitting here with an ev of - $50 million Basically, the market is saying that what you're investing in, they do not believe in or no one cares. basically the market is saying that what you're investing in they do not believe in or no one cares Correct. Correct. correct Okay. Do you buy back stock or do any of that or? Okay. okay Do you buy back stock or do any of that or? 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? Yep. yep I'll repeat what you're saying just so people hear it. i'll repeat what you're saying just so people hear it Is that fair? is that fair Yeah, yeah. The question was. Yeah, yeah. yeah yeah The question was. the question was The question that we're getting is. The question that we're getting is. the question that we're getting is No, no, for the recording. No, no, for the recording. 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. Yeah, no worries. yeah no worries The question being asked is around our cash balance position and the uses of that cash. 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. 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? 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. 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. 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. 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. 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. What we did earlier this year is we announced a $40 million share buyback program over two years, $5 million, roughly a quarter. 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. 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. 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. 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. 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'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. 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. One last question. one last question Yeah. Yeah. yeah Was there something recently in the last three or four months that you said that basically got the stock to go in half, [audio distortion] or is it just slowly just declining out of its own because it's declining? I mean, was there a negative announcement? Was there something recently in the last three or four months that you said that basically got the stock to go in half, [audio distortion] or is it just slowly just declining out of its own because it's declining? was there something recently in the last three or four months that you said that basically got the stock to go in half [audio distortion] or is it just slowly just declining out of its own because it's declining I mean, was there a negative announcement? i mean was there a negative announcement No. No. no There was no negative announcement. There was no negative announcement. there was no negative announcement
Speaker 3: There wasn't any specific announcement. I mean, the challenges with the public health space of kind of pressures on legacy. There wasn't any specific announcement. there wasn't any specific announcement I mean, the challenges with the public health space of kind of pressures on legacy. 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. Healthcare stocks are. 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. 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
Speaker 2: 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 Colli-Pee for STIs, we are going to submit to FDA by the end of this year or early next year. No. no What we've talked about for 2026 as far as catalysts, it's really our near-term roadmap, right? what we've talked about for 2026 as far as catalysts it's really our near-term roadmap right It's around product launches. it's around product launches What we've said publicly is that for CT/NG, our Sherlock molecular device, and for Colli-Pee for STIs, we are going to submit to FDA by the end of this year or early next year. what we've said publicly is that for ct/ng our sherlock molecular device and for colli-pee for stis we are going to submit to fda by the end of this year or early next year 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? Following up on his profitable growth questions, COVID became a significant part of the story a few years ago. 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. 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? 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 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. Yeah, so COVID did a couple of things. 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. 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. 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. 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. 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. as you can imagine as we add volume, we are not adding that fixed infrastructure Margins can then grow from there. 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. 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. 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. 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. 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. 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. again we did in 25 years we had three products that we developed Now we're trying to do that on an annual basis. now we're trying to do that on an annual basis 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? That's excellent to hear. that's excellent to hear I think you also, because of this, you pointed towards 50% plus gross margins in the out years. 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? what are the main levers that you need to pull to get there 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. Yeah, there's the normal stuff you do every day, right? 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. 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 never going to change That's automation, that's procurement savings, all the normal things that you would do. 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. there was the big streamlining of the footprint where we again consolidated our manufacturing The next step is really volume. the next step is really volume That's why we're talking about our pipeline revenue growth launches in the upcoming year. 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 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. 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. the math just says that your margins should grow from there in an exponential manner 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. I think part of this equation has also been on operating expenses. 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. 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 Yeah. The majority of that is the clinical trial. Yeah. yeah The majority of that is the clinical trial. the majority of that is the clinical trial Correct. From here, would investors consider 3Q operating expenses and gross margins a good baseline moving forward? Correct. correct From here, would investors consider 3Q operating expenses and gross margins a good baseline moving forward? from here would investors consider 3q operating expenses and gross margins a good baseline moving forward 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. I think it's a good baseline. i think it's a good baseline The one thing we've said that ebbs and flows is that innovation spend. 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. 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. 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. 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. 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. 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. we want to get a natural rhythm where as one kind of winds down we are getting ready and launching up the next one 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? This may be a bit early, but the $7 million correlates been on that trial. 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? once that's completed do you expect to spend roughly the same amount on 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. That's the part that's the ebb and flowing that I'm talking about. that's the part that's the ebb and flowing that i'm talking about That's the part that will up and down. 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. 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. 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. 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 Got it. How do you balance the reinvestment for growth in diagnostics and sample management versus driving profitability from here? Got it. got it How do you balance the reinvestment for growth in diagnostics and sample management versus driving profitability from here? how do you balance the reinvestment for growth in diagnostics and sample management versus driving profitability from here 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. It's really a balanced approach. it's really a balanced approach It's a balanced approach of what's the return on invested capital of those opportunities? 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. 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. we are looking right now it's innovation and growth Profitable growth is what we're looking for. 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. we have enough very strong return on invested capital opportunities that we're going to continue to invest Right. You mentioned the $216 million of cash. Just how are you thinking about capital allocation from here? Right. right You mentioned the $216 million of cash. you mentioned the $216 million of cash Just how are you thinking about capital allocation from here? just how are you thinking about capital allocation from here 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. Innovation is the first word. innovation is the first word That's our number one deployment. that's our number one deployment Share repurchase, again, we talked about it earlier. 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. 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 is the number one thing Innovation, both organically and inorganically. innovation both organically and inorganically We're agnostic to how we get the innovation. we're agnostic to how we get the innovation We look at all avenues, and we've demonstrated that. 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'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. 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. 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. we believe we've taken a very prudent approach to that as we deploy our capital 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? Got it. got it As you look out over the next three to five years, what do you see as the biggest growth engines? 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? 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 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. 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. 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. 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. liquid biopsy is an area that really excites us Infectious disease are areas that excite us, whether it's viral, bacterial. 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. 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. 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. 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. we have to match the area the opportunity with what exists but that's how we're looking at it Got it. I think we'll leave it there. Ken, Jason, I appreciate you all for joining us. Got it. got it I think we'll leave it there. i think we'll leave it there Ken, Jason, I appreciate you all for joining us. ken jason i appreciate you all for joining us Thank you very much, Mac. Thank you very much, Mac. thank you very much mac Thank you. Thank you. thank you Appreciate it. Appreciate it. appreciate it Thank you. Thank you. thank you