All right. Good afternoon, everybody. I'm Jacob Johnson, Life Science Tools and Services Analyst here at Stephens. Pleased to be joined today by the team from OraSure, or maybe we're still calling it OTI, CFO Ken McGrath and VP of IR, Jason Plagman, and Nashville native, for the record. Before we get started, fireside chat. I'll try to pause along the way if anybody in the audience has questions. With that out of the way, Ken, I'll turn it over to you for any opening comments.
Thank you very much. I really appreciate it. Before we get started, I just want to remind everyone that what we may be discussing, any forward-looking statements today, actual results may differ from those projected in any forward-looking statements we make. We would refer you to our most recent 10-K, 10-Q and 10-K filed with the SEC, where we discuss the factors that could cause our actual results to differ. Now that the lawyer comments are out of the way, keep going. Yeah, no, I really appreciate it. You know, we're really excited to be here and really excited to talk, to tell about our story and the progress that we're making. For us, it's about really consistency in our messaging. It's our three pillars that we're continuing to evolve over the last two years or so. One around strengthening our foundation.
And we talked a lot about that during our last earnings call, and we'll talk a little bit about that today. The other is elevating our core and accelerating profitable growth. And that's really where we're transitioning into that phase now of our business as we go. We mentioned, and you'll get into this, I'm sure, our last earnings call, our cash flow from operations for our core business was positive. And that's a big turning point for us, where we now want to take our cash and our business and now invest those resources into future growth and future profitable growth.
Yeah, $280 million of cash. That's not nothing. We'll come back to that. But maybe we'll look back at where you've been. Ken, you guys have been pretty busy the last couple of years on a number of efforts, including kind of streamlining the business. Can you just talk about first the decision to exit the microbiome business and then the decision to kind of wind down the risk assessment business, which was the most recent update?
Yeah, it's all part of our plan. This has been a part of our plan, which is and it starts with, again, the strengthening our foundation. A couple of years ago, where we started it, where we went down to one business unit for leveraging our infrastructure, and we wanted to align our cost structure in a post-COVID world, so we've taken some of the necessary actions there, and then it plays along with our operation efficiency that we've driven with consolidation, with leveraging our automation, our efforts in digitizing our systems to improve efficiency, consolidating sites, and eventually leveraging volume as we go. The good position we're in now is we have an infrastructure that can support incremental volume without step function investments required, and so winding down some of these businesses was consistent with that approach.
In particular, these two businesses, an example of Diversigen, it's our microbiome services business. We're still in the kit business, but from the services perspective, so running the tests. In that particular case, think of these Illumina NovaSeqs, these big machines. It's a volume game. If you don't have the volume, you can't leverage the cost down to be profitable in the business, and this is one of those markets that got hit with the COVID world. In 2019, when we invested, it was an exciting area. Still is an exciting area, but with COVID, a lot of the industry kind of refocused their investments in other areas and delayed some of the advancements in that area, so for us, we just didn't see some of the near-term visibility that we would have liked to see. And the business wasn't profitable.
So the run rate for revenue in the business at the time, I think we said was about $4 million. And our cost that we removed by exiting the business was $10 million. So you could kind of do the math of the profitability there. And we did exit the business fully in Q3. And I say it, but we exited the service as part of the business. We're still in the kit part of the business, and we are still very excited about that. And it's a good portion of, it's a good chunk of business for us. On the risk assessment, this is an area that really, it's an area where the addressable market has been declining overall, really for external factors, legalization of marijuana, some of the Department of Transportation guidelines that were changed. And our legacy products just didn't align with those guidelines.
It was a business that was a little bit losing money, and we just felt it wasn't aligned with our core focus. So we made the decision to exit. We are going to be fully exited by the end of this year for that business. And I think you're going to ask me this question, but maybe I'll jump to it just ahead.
Go for it.
The question we got asked during the last earnings call was, well, is this it? And the short answer is yes. This is, you know, obviously, we could always change our mind if things, if the market dynamics change. But this is the last of the businesses that we felt were unprofitable and weren't aligned with our future growth. And now it's all about taking our capabilities, taking the cash that we've built up over the last couple of years, and now deploying that internally and externally to grow the business.
Maybe just since you stole the question, I was going to follow up with, I'll switch it up on you and ask a different one. But I'm just curious, you know, I'm guessing deciding to divest a business, deciding to wind down a business, that's probably somewhat time-intensive on management. And so do you feel like as you get into next year, to your point of, and I want to come back to that, but at a higher level, but do you have more time to kind of think offensively after maybe being on defense is probably the wrong word, but you probably get the gist of what I'm getting at there.
Absolutely. No, it's a great question, and yeah, I don't want to mislead. We are looking and have been looking at growth opportunities for the years, but you're right, there is a limited amount of time and capacity, and I joke, our CEO, Carrie, I'd say she spends 90%-95% of her time now on investment opportunities and growth opportunities. That is her focus. It was in the past. I don't want to take away, but you're right. When you take some of these actions, they don't just happen the day you announce them. We've been thinking about it thoughtfully. It involves people and a lot of important decisions, so we want to make sure we're making the right decision, and we want to make sure we exit in a way that's aligned with our current customers. We don't want to annoy customers that we're exiting from.
We're not doing it in the right way, the right manner. So that takes effort. So yes, you're absolutely right. As we exit these businesses, again, Diversigen exiting Q3, risk assessment exiting this quarter fully does free up capacity for us to spend our limited time on growth opportunities and playing offense.
Okay. I promise we will get to that. But maybe just the one other thing that's kind of been going on the last couple of years, COVID testing stuff, you know, Carrie and you and the team did a good job of capitalizing on that opportunity. And I think this last quarter, if I'm not mistaken, it seems like it's starting to get to endemic levels. I think it was 2 million-ish in the last quarter. Do you think that's indicative of endemic demand? And is that kind of what we should pencil in going forward? And any reason we could see that pick up in the future, you know, outside of another COVID wave, which maybe that's the answer.
Yeah. So for COVID, we were aware of our largest U.S. Government contract and the timing of that. And that was ending in Q2. So we planned accordingly. We ramped down resources. So our cost base, our cost structure was in place with that. In Q4, we had about $2 million of revenue. We expect, and we said in our guidance, we expect about $1 million. I'm sorry, in Q3, we had $2 million. We expect about $1 million of revenue in Q4. And then we have a stay warm contract with the government, the U.S. government, that ends in Q1 of next year. After that, we should probably see revenues below $1 million per quarter going forward. With the change in administration, we don't expect an uptick in COVID testing. So we don't have expectations for that.
We're planning quarterly revenue in that particular area below $1 million, where we have contracts with California Medi-Cal that we're working with, and then other smaller local government contracts.
In theory, not that you're guiding to 2025, but in theory, COVID's kind of de minimis part of your business going forward.
Correct.
So we've talked about what's gone. So let's pivot to what's left. Can you just walk through what the key offerings in your portfolio is, you see them, and then how you think about the kind of long-term growth outlook for these businesses, maybe putting aside some of the growth opportunities you've announced?
Yeah, we're excited about the spaces that we participate in. We're excited about the point of care diagnostic space. We're excited about sample management collection devices. And we think there's growth opportunities there that we can play in. And then what gets us really excited is it aligns with our internal capabilities to win and grow in these spaces. We have capabilities when it comes to channels, in particular for diagnostics in the public health channel. We have operational efficiency capabilities. With COVID, we built up a lot of operational capacity that we can now leverage in other parts of our business. And then we have significant regulatory capabilities. In an FDA world, we have the ability to develop, launch products, and have the quality systems for those products. So that really excites us.
And in particular, you know, from the sample management collection, we're really excited about precision health and the future that has on healthcare. And so, yeah, we're excited about the spaces we play. We think we have the right capabilities to win in those spaces. And now it's just doing more. We've talked about it where in our diagnostics business, we're really looking to develop a partner for more tests in the space. In diagnostics, we play in the infectious disease, sexual health, and in the respiratory area and spaces. And what we want to do is add more to that. We did a partnership earlier this year with Diagnostics Direct on a syphilis test. And we mentioned a term that's being used a lot now called syndemic, synergy epidemic.
What we're finding out is that, not finding out, but what we're working with is if someone has HIV, a lot of times they have a higher probability of having HCV or having syphilis. And so with a lot of the partners that we have in the public partnerships that we work with, being able to serve the entire condition, the entire syndemic condition is really helpful. So what we've tried to do is provide an offering and our suite of offerings in HIV, HCV, and syphilis that can meet those conditions. Think about it in a typical public environment, public health environment. The individual comes in, and when you serve that particular patient, a lot of times they may not come back. So you want to be able to treat them and diagnose them for all the conditions while they're there.
In point of care, you get a result within that 10 or 15 minutes, and then you can provide the proper treatment at that time. So, long-winded way of saying, we're excited about the spaces that we are in. We want to now continue to invest in those spaces, whether it's internally or external partnerships or M&A. We want to deploy our capital now towards those areas.
Maybe one follow-up on the diagnostics piece of things. You mentioned kind of the importance of having a more holistic portfolio. So I think HIV, HCV, syphilis. Is there anything else you really need to add to that, or those kind of the big three you needed to have?
There's a lot of other spaces. I'm not saying implying that we're doing anything or anything, but there's areas like chlamydia, gonorrhea is a big area. In my prior life and past roles, that's a big market. So you can imagine areas like that that play to our sweet spots of our channel as well as our expertise in the sexual health area.
Gotcha. And then on the molecular products business, I think historically some larger customers here from the ancestry testing market, you know, I think you've announced, I'm not sure how many partnerships there and trying to get into some other end markets in recent years. How do you think, I guess one was the outlook for some of that legacy business. What does that, you know, is that flattish from here? And then how should we think about some of these other opportunities contributing?
Yeah, we can talk about green shoots, where we want to diversify our customer base, both in number of customers as well as types of customers. So we've done that in the number where we're doing more partnerships and signing on more customers, but also in the types of customers, not just consumer-initiated testing customers, but also pharma and biotech. We mentioned examples like Grifols and other partnerships that we've worked with. And that's helped us diversify our customer base and get into new areas. Again, we're really excited about this space of precision health. And we want to be positioned to win as that area continues and that space continues to grow. And then for some of our existing customers, it's really signing multi-year contracts and signing up. We want to be part of their growth. We want to be part of their processes.
And we feel like as we engage in their processes, we become a pivotal element that, you know, there's a stickiness factor there as you work with them. So we think that's really helpful. And again, there is this dynamic of balancing out the portfolio from just customer-initiated testing to kind of clinical use testing, which has a more recurring approach to it versus, you know, Ken McGrath finds out I'm from Ireland. I do that once. I don't have to do that every week versus, you know, some of the clinical use tests, whether it's cancer, whether it's HPA, UNC, other areas, there's more of a recurring nature to it, which we're excited about.
On that clinical market, I think on the 2Q call, you talked about expanding OraCollect into saliva-based liquid biopsy applications. I think when people think about liquid biopsy, they think about blood, and we'll get to blood and the opportunity there for you all. But what's the opportunity for the kind of the OraCollect, the saliva liquid biopsy market? It's been a long year, but I feel like at some point this year, I read something about that, that's becoming a new area of efforts just given, you know, it's a lot easier to spit than get a needle in your arm.
Yeah, non-invasive biopsies. Liquid biopsy has been really important. And it's more about access to patients and ease of use for patients, to your point, versus blood draws and other areas. You'll hear a lot of theme in some of these markets, somewhat consistent, is the addressable markets we think are in the hundreds of millions. We think these are big spaces, liquid biopsy and other places. And a number I think we've thrown out in the past is that we think the collection devices represent like 10% of some of these spaces is kind of a rule of thumb. So when you hear about these billion-dollar market opportunities, you do 10%, you get into hundreds of millions of opportunity. And we think that plays for this saliva collection area. And the thing that's encouraging is all the research.
There's a lot of research going into cancers, whether it's oral cancer, head and neck cancers. And that just fuels kind of the need and the market opportunity in these areas. So we're excited about that. And we're excited, look, we're excited for all the non-invasive liquid biopsy area space. You know, for example, we think it's a $2-$3 billion market in particular with stools, probably $2 billion of that, right, as big with some of the players there. But we also think urine's a big opportunity with our Colli-Pee device. We think we're positioned to play in that space favorably. And then saliva is probably $100 million-$200 million in that space as well.
Got it. Maybe, you know, I just said people don't like to get needles in their arms, but you know, blood is a big piece of the diagnostics market. Earlier this year, you know, where you have invested some money is the Sapphiros deal where you've got, you made an investment, and then you've got a distribution agreement. Can you talk about, you know, the strategy behind that investment and what Sapphiros brings to your portfolio?
Yeah, it's a partnership going well. Sapphiros has some established leaders in the space that have been successful, so we're excited to partner with people that know how to win in the space, and what they're doing is aligned with our strategy, so for example, we have a lot of distribution partnership deals with them as part of this deal. We have distribution agreements, and what it does is it leverages our channels and leverages some of their innovation, and their innovation is really well aligned with where we want to go. For example, diagnostics, they have some innovation potential opportunities in lateral flow that get you molecular-like results in a lateral flow type offering, which could be exciting. They also have some potential opportunities for lateral flow type testing at a fraction of the cost structure, and that's exciting for us.
It can improve, you know, it can improve cost, COGS in general, margins, but also could open up other markets. Think international markets, where cost is a little bit more prominent as a decision factor. They also have opportunities, as you mentioned, in blood, in our sample management collection area. One of the areas that we're working with and we expect some great progress in 2025 is in small volume blood, where you can think of it as a little bit larger patch you put on your arm, can collect blood versus going to a patient service center and having a phlebotomist draw blood. Now you can mail out this device to someone's house. They can take a sample, mail it back.
It provides, again, ease of access, ease of use, access to a lot of patients that may otherwise not have gone and gotten their blood drawn. We're really excited about the opportunities and how it measures really well with our portfolio and our strategy and our opportunities.
Maybe one comment you made there that struck me is, I think Jason will remember this from a prior life, you know, healthcare is moving closer to the patient, closer to the home. You know, some of the things you have kind of enabled that. Do you still think that, does that theme apply, you think, to the diagnostics market? Do you think we see the world moving in that direction?
Yeah, I think COVID drove accelerated a bit because it made it more, it made it more of an expectation for patients, so from that perspective, COVID accelerated that plan. I think it's still a long-term trend that's going on where it's going to the patient where they want to consume their healthcare, and our diagnostic point of care devices play into that. Our collection, our self-collection devices play towards that and enable or allow a patient, again, to consume healthcare on their terms where they want, and what it typically does is then it opens up to folks that may not have just consumed that healthcare and may have just opted out. Now it gives them a path to opt into diagnostics or treatments, and that excites us.
That's our goal is to play towards where we provide a quality product that's ease of use at the right price that patients can, again, consume on their own timeframe.
Got it. You know, so you mentioned Sapphiros as you're working on a collection device next year. I think when you announced that in January of this year, which again seems like an eternity of that, lots happened. You talked about it adding 2% to your top line growth outlook beginning next year. Do you think that's still in play?
Yeah, we still think Sapphiros is going to provide some meaningful growth to us in 2025. You know, obviously a lot of this depends on when you submit something for regulatory approval. Timing could be an issue there. And some of it's out of your control, you know. But yeah, we're still excited about what Sapphiros will provide for us, both in the sample management space as well as the diagnostic space. And they haven't announced, I believe, what areas they're looking at for diagnostic, but you can imagine it plays in the areas that we're excited about. There's a lot of the common areas in infectious disease and other spaces. So it aligns with that as well. So yeah, we're still excited about the opportunity that it can provide for us.
Got it.
I like how I avoided answering the question because we haven't given guidance.
Yeah, yeah, yeah. Yeah, I should have gone with the obligatory. I know you haven't guided in 2025, and we'll get that in February, part of that question. Maybe the other thing on kind of the blood side of things is the most recent one on the last call. You talked about a new launch for the blood proteomics market. Can you talk about what that offering is, the size of the opportunity, how we should think about the revenues from that?
Yeah, so we're very excited about this opportunity. We expect it to launch in the second half of next year. And the reason we're excited is it kind of hits our strategy on all elements. So when you look at sample management, one of the things we say that we want to grow in and keep adding to is around sample types. So this adds blood as a sample type. Different additional analytes, this adds protein, has a different analytes and applications. And this adds potentially liquid biopsy, Alzheimer's, other areas. So it kind of hits all the points. And what we provide, the value it provides is it provides a blood collection device that stabilizes the sample and allows it to deliver at room temperature. So we're really excited about this and the opportunity it provides.
As far as market opportunity, you can imagine what I'm going to say, hundreds of millions in the addressable market. That seems to be a go-to phrase for a lot of diagnostic spaces. And we don't think this is any different. It's a sizable market. It takes time. All these things take time. They usually start out as research use and then they evolve into more mainstream. And this is no different than that. But you know, we're excited because again, it's nice when something checks off all the boxes that you're looking for and it aligns with your strategy and kind of validates what we're trying to do.
Kind of maybe I'll pause there if anybody has any questions. I want to wrap on kind of the long, long-term outlook and growth opportunities, but maybe first before we get there, just talk about, you know, cash flow and margins, et cetera, and so maybe we'll start here of like, there's been, I feel like there's been a few moving pieces on the expense line, right? You've got the COVID wind down, you've got the microbiome services, and then the risk assessment coming out in 4Q. Can you just talk about how much of those costs across those three things are kind of out of your numbers on maybe the OPEX side of things? Then we'll hit on gross margin after that.
Yeah, so for OPEX, what we've said publicly is that, so for Q3, we were $23 million GAAP. And then when you take out stock comp, we were about $20 million. We said publicly that that's a good run rate for us. We're in a good place there. We're at that spend level. We're breakeven cash flow from operations and we can grow from there. And we can leverage that spend level. So we told people that's a good number to kind of pencil in for a good run rate. Now it could change if we decide to deploy some of our capital internally and think of things like if we're going to invest in a new opportunity, there might be clinical trials. And those can be short-term, one-time, you know, several million dollars, but there's a launch on the end of it.
So there's something at the end of the, you know, at the end of the rainbow. There's some gold there of revenue and opportunities. So you could see changes from there, but those are specific one-time. They're not people headcount ongoing expense related. They're one-time expense where we're making an investment at that period for a launch and growth in the future. So we're excited about those. But taking absent of those, the run rate we have right now in Q3 is a pretty reasonable run rate. And that's a good way to think of it. From a gross margin perspective, this year we're about mid-40s or so. We gave guidance to say, hey, in the future years going forward in a couple of years, we'll be in the 50s. And we have no reason to back away from that.
With the efforts that the team has made, the operations team has made in consolidating our facilities, in leveraging automation, we've said, we said on the last call, I think last week, that we think our operational capacity is at about 30%, so we have 70% more potential that we could add, and that's a rough number. It could change depending on what types of products and all that, but what that gives us insight to is that as we increase volume, we can really leverage margins. We don't have to add fixed costs, and that's a really great place to be, so now it's deploy that capital to get the volume, to leverage the infrastructure to grow the margins kind of play right now.
I don't think you've quantified it. Is there any way to think about how we should think about incremental margins from here or a rule of thumb? Hard to say.
We haven't said. I don't think the only thing we may have said is, I don't think we've said it. I don't think we gave the fixed variable split, but you can imagine there's some significant margin accretion if we can leverage the volume.
Okay. Got it. All right. That's helpful. All right. So maybe let's touch on the balance sheet. Just remind me where that stands. And then how do you think, you know, you've talked about, you know, growth opportunities, et cetera. How do you think about capital allocation from here? Preference organic efforts, inorganic efforts, et cetera.
Yeah. So, for Q3, our cash flow from operations was $13 million. A chunk of that, and the reason I start with that is a chunk of that about $11 million or $12 million came from AR improvement. Yep. We think our working capital, our AR, our inventory, our accounts payable are kind of at our run rate. You know, short of we grow revenue significantly, which I hope we do, you know, that would have some, you know, incremental changes to that. But at the current run rate we're at, we think our working capital is at a good place. It's good that if you take that out, we're still cash flow from operations positive. We think we're in a solid position there.
What it enabled us to do and all the hard work the team did is we built up this cash balance of about $279 million. I guess exactly $279 million of cash. What we're looking to do now is we meet with the board and we have this conversation every time we have our board meetings. We just had one earlier Monday. We talk about our cash position and the uses of cash, right? We could do anything from M&A, CapEx deployment, return to shareholders, right? All the, I guess, dividend. We're probably not in the dividend camp right now. For us, what we get excited when we have this conversation, what we talk about is, are the opportunities to invest still there? We think resoundingly yes. Are the markets we play in still exciting? We think resoundingly yes.
And so if that's the case, then we want to focus first on deploying on innovation, whether it's internal in R&D or external in partnerships or M&A. And that's where we're focused right now. If we ever get to the point where we have different answers to those questions, then of course, obviously we'd think about how do you deploy that? We don't think we're at that point right now. We think there's a lot of opportunities to deploy our capital both internally and externally to grow the business. And there's great returns from that deploying that capital.
Maybe one follow-up there. Just, you know, you did do, you made investments in Sapphiros earlier this year. But I'm just curious, you know, you've had a decent cash balance for a little while now. It's certainly grown due to some of the working capital actions and the COVID opportunity and the like, right? But, you know, have you just not seen M&A opportunities or was there an element of we need to figure out, we need to sort some stuff out internally before we start thinking about doing external things?
Yes and yes. A little bit of both. We have the luxury given our cash balance and break even that we can make sure we're picking the right opportunities and we're not jumping at the first opportunity. So we're looking through, we have a set of criteria that we look through. We look for industrial logic, which is a fancy word for, you know, does it meet our strategy, then we look for the financials to make sure the financials make sense, and then we look for kind of cultural fit. Those are the elements we look through, and we look through, you can imagine it's a numbers game in M&A. You look through hundreds and thousands to find the right ones, and given our uniqueness of our position in the space, there's very few opportunities that would go where we wouldn't be asked to opine on.
So we're seeing them all. Now it's a matter of selectively picking the right ones that make sense. And then you can't, the other side has to be willing to partner. And you've seen some examples where we partner like Sapphiros's. I think you're probably saying it right and I'm saying it wrong.
I'm not even sure anymore now.
I'll apologize to them if I'm saying it wrong or not, but we did a partnership opportunity there, and you know, we've always said date and then maybe we take it down the road if we'll see. We did another one with Diagnostics Direct where we did a partnership opportunity where we bring our capabilities, and you know, those are some of the ways we've dipped our toes in certain areas and leveraged our capabilities, but we are open to all types of structures. We have a pretty good balance sheet, so from a cash perspective, and then also we have no debt. We have equity that we could also deploy, so there's opportunities. We have space to play in most opportunities if need be, so we're looking. We are being selective to make sure it's the right opportunity.
But we also aren't waiting for the absolute, you know, perfect thing. You know, that doesn't, the unicorn doesn't come. That's why it's a unicorn doesn't come, you know, all the time. So, but we're trying to be selective in what we do.
Got it. Maybe I'll pause one last time for any questions. Maybe we'll end on this, Ken. One, if you have any kind of parting thoughts you'd like to give or maybe two, another way to ask is just, you know, a lot of blocking and tackling the last couple of years, a lot accomplished. Just curious if you have a view of, you know, four or five years from now, what do you think OraSure looks like?
Yeah, we're going to. I'm not saying I'm promising anything, but I want us to be much bigger. We want to leverage our infrastructure and grow our margins. We like the spaces that we're in and we want to continue to grow in those spaces. Q3 was a nice moment of being cash flow from operations. I joke and I'm not hoping not offending anyone politically, but we don't want it to also be the mission accomplished sign that George W. Bush did, you know, in Iraq because we recognize you got to keep working on operational efficiency. You got to keep plowing away and finding opportunities to improve your efficiency over time. But it is a nice pivot point for us to now focus on offense. I think you said it probably in your report. You said we're pivoting to offense. I think it was very well said.
That is kind of the approach now. Let's deploy that capital to grow the business and leverage all the infrastructure, all the hard work the team built up, and take advantage of that.
Got it. Well, Ken, Jason, thanks for being with us here in Nashville.
Thank you. Appreciate it.