Quanterix Corporation (QTRX) Earnings Call Transcript & Summary

Good afternoon, everyone. My name is Matt Sykes. I'm the life science tools and diagnostics analyst at Goldman Sachs, and thanks very much for joining us this afternoon. I have the pleasure of hosting Quanterix this afternoon at the conference. And I want to introduce Vandana Sriram, CFO; and Francis Pruell, Head of [Audio Gap]. Thanks for joining us.

Thanks for having us.

I was going to start with some of the recent Q1 highlights, but I think more topical is the Lilly donanemab AdCom and the implications for Quanterix, and would love to get some of your high-level thoughts on some of the discussion that took place and what implications you feel there are for Quanterix and blood-based diagnostics for Alzheimer's.

Sure. Happy to comment on that. We were very pleased to see the results of the AdCom. The fact that all of the AdCom Committee members unanimously voted to move forward with the proposal was very encouraging in our minds. For us, there were a couple of key takeaways that I think are particularly relevant to Quanterix. The first was around the discussion on testing for a tau-based testing and then the other was around early detection. So double clicking into each of these. We've long said... [Audio Gap] Testing as a way to get on the drug would be a barrier and would preclude the real uptake of the drug. So from that perspective, we were very encouraged to see that, that was not a requirement. We strongly believe that blood-based biomarkers really are the future here. And really, that's the most cost effective, the most accessible and now actually the most accurate way as well to be able to continue to monitor the disease. So we think blood-based biomarkers will continue to have a place not just in that initial screening, but also in monitoring the therapy and then being able to get people off the therapy. So we thought that was a net positive. The other item which we've talked about quite a bit is the importance of early diagnosis. There are a lot of tests out there in the market now. A lot of those work only in much later stages of the disease, by which time these drugs are not as effective. Our test is the only test that really has the ability to detect disease before symptoms really are much further along. So the reiteration of that importance of early testing and the importance of catching this early, we think is also a net positive for us.

Got it. And I think there's obviously a lot of focus on the potential label. It seems like based on the discussions, it was trending towards a general label. But I do think that what kind of gets lost in the noise is sort of a more deeper kind of foundation for the potential for these diagnostics is the fact that we will have another drug on the market potentially. And so could you maybe talk about sort of what sort of the uptake that we've seen in Leqembi, which seems to be kind of improving a bit, but it got off to a slow start. But then the introduction of the new drug, how important is it just to have additional therapies on the market in order to advance the diagnostic infrastructure?

Yes. We think that really is critical. Just as a patient, you're curious to see whether you have a disease state or not. But if there's nothing you can do about it, that's an incredibly frustrating experience as well. So the Leqembi update has definitely been slower than expected. I believe by the end of the first quarter, the initial expectation was 10,000 patients, but we really landed at closer to 5,000 patients. Definitely having another drug on the market is incredibly helpful. The other thing that we've seen as being incredibly helpful is just the awareness and the dialogue around the disease. We haven't really had a therapy on market for a while. Now we're close to having 2. As we look at research on other clinical trials and other activities that are going on, we definitely see that as a positive catalyst in terms of the level of interest that we're seeing on the research side.

And then label aside, when we speak to doctors, it sounds like they're still doing some level of testing for tau prior to putting patients on there and if it might not necessarily be required. Do you think that it will become sort of a part of the protocol in order to test for patients to get on to therapies to look at some level of tau, even if it's not sort of directly recommended by the label?

Yes. I think, again, as the neurologists get additional information about these tests, some of this is going to evolve. If you did have to look at tau, again, we think blood-based biomarkers could do that just as effectively. So we still feel like the standard of care eventually would evolve to that just based on accessibility and cost. And just being able to get to a PET center and get an appointment is still incredibly hard right now.

And then given your relationships you have with Lilly historically and the conversation around monitoring post patients being on donanemab, do you think that puts Quanterix in a good position to work with Lilly on the monitoring post patients going on?

Yes. We definitely see monitoring as a critical part of this process. So the initial step is really getting a patient on drug, which we do think blood-based biomarkers will become a standard of care. But then there's the continuous monitoring of the patient as they get through that disease progression. And then also at the end of that process to get them off drug and to monitor recurrence from that point onwards. So we do believe that this is not a one test for a drug kind of situation, but this is really more a continuous standard of care.

Got it. Maybe shifting back towards sort of Q1 and some of the takeaways you had from the quarter, you've had some time to digest it. We spoke to a number of investors in terms of feedback. What are some of the main takeaways that you want people to have about Q1? And then how does this inform your guidance that you've maintained in the year?

Yes. So I look at every quarter from a couple of lenses. One lens is kind of that immediate spectrum of how do you do on your results. And then the other is a slightly more longer-term strategic perspective. So on the first perspective, I think our big takeaway coming out of Q1 was that the RUO business continues to be really strong. In what is decisively a difficult environment, a lot of our peers are either at flat growth, a lot of the larger players at flat growth. We were able to post a 13% top line number. And that's really coming from the strength of our business model. Even as we see CapEx being relatively constrained, we saw our instruments definitely decline pretty significantly. We saw the demand for research still continue to be really strong. It manifested itself in a service stream instead of an instrument stream, but we still did get that volume, which gave us the comfort that the demand continues to be strong. And then on the execution side, again, we had a pretty strong quarter. On a sequential basis, we improved gross margins by about 800 basis points as the results of our transformation process really started to land and start to stabilize. So we felt really good about the execution and the RUO business in the first quarter. And then from a strategic perspective, the couple of big events that we'd like to highlight for the first quarter really was on the diagnostics front, continuing to make progress, we'll see breakthrough designation for our p-Tau 217 test. And Lilly launched the CertuitAD test, which is also on our platform. So felt really good about that. And then on the RUO side, we've talked about this being the year of innovation of continuing to innovate, both on the instrument as well as on the assays. And we released 5 new assays in the first quarter, and we're on track to release about 20 new assays throughout the rest of the year.

Got it. One dynamic that's taking place in your business, and you talked about the robust business model is that as we've been in a more constrained capital equipment environment, your instrument growth has trended down, but that's not unique, certainly in the sector. But Accelerator Lab has really picked up the slack and been a strong performer for you. I think there's some tendency of investors to think about it should be either or. I'm wondering, however, just given the level of growth you've seen in Accelerator Lab, if you could see a scenario where instruments could pick up because of capital equipment demand, yet Accelerator Lab stays strong, just given sort of the new clients you're bringing into that. Maybe talk about that dynamic because I do think there's a perception that when one is working the other one doesn't. I'm not sure it's a zero-sum game.

That's right. That's right. So for those not familiar, the Accelerator Lab is our CLIA-certified lab, which is based in Boston in our main facility. And that lab does everything from exploratory research to support for clinical trials as well as sample testing. So initially, as we set up the lab, it was really all about helping on clinical trials, some amount of sample testing. Over the last 12 to 18 months, as CapEx started to get tighter and tighter, we had a lot of customers come to us and say, "Hey, I can't really buy an instrument right now, but I've got the study that I need help on or I've got this piece of research that needs to be completed. Can you help us with that?" And through that, we actually landed up building a franchise that's now incredibly valuable to us. The way we see this evolve is there's definitely some small cannibalization of revenue from instrument into Accelerator. But at the same time, we've started to build Accelerator into its own stand-alone value proposition. So, on the one hand, it's a bit of a try before you buy. Customers run a project through Accelerator. It goes well. They go place an order for an instrument. On the other hand, there are larger trials or larger discrete events where our customers need some search support, and that search support is now coming through the Accelerator Lab. So Matt, to answer your question, the way we see this play out in the future is we believe that the 2 will coexist and they're actually complementary to each other in many ways. So we, in the last several quarters, had growth rates that have been north of 50% on Accelerator. Over time, as instruments come back, we wouldn't expect to sustain a 50% growth rate every quarter. That would probably normalize to our portfolio growth rate. But we see the 2 coexist, where the try-before-you-buy dynamic will remain, the search dynamic will remain. And then a lot of the specialty projects that we continue to do for our customers are very valuable. This quarter, we actually saw, Matt, that about 80% of our Accelerator volume was actually from repeat customers. So we are really starting to build that up as a product offering on its own.

Got it. Maybe let's take a step back and talk about the Simoa platform. There's been a number of competing tests that have come out, various biomarkers. Lately, it's been p-Tau 217 for obvious reasons, the proposed guidelines, et cetera. But maybe talk about sort of the strength of the small platform, the relevant comparisons when it comes to either area under the curve sensitivity, specificity to what we've seen come recently introduced by the competition.

Yes. So maybe just a little bit about the Simoa platform for those who are unfamiliar and then we'll talk about the AD testing in particular. So our Simoa platform works a lot like a traditional ELISA platform where you've got to capture antibody and a detector antibody and kind of create a sandwich between the 2. What's different about our technology, though, is using either a bead-based or a cleaner assay, we're able to measure this in extreme orders of sensitivity using a digital signal. What that results in is basically sensitivity at the femtogram level, which is about 1,000x more sensitive than the competing platforms. That's kind of what we build our business on. And at this point, our business is about 80% neurology-focused, mainly because the need for sensitivity is extremely high in neurology, and that's where we got our start from. Now when you take that into what's happening on the diagnostics space, it's interesting. I've been with the company about 8 or 9 months, and I've seen this change pretty dramatically just in the few months that I've been here. We've all centered around p-Tau 217 really being the leading biomarker for now, for Alzheimer's. Our test has -- we have 2 tests. One is through our LucentAD platform, which is in excess of 90% sensitivity, specificity and accuracy, and has a 30% indeterminate zone. What that means is when you go get that test, either you are a clear rule out or a clear rule in, you can either leave the doctor's office happy or you've got further work to do and get on therapy. There's a 30% indeterminate zone at which point you probably need a confirmatory set. Similarly, the CertuitAD test that is sold through Lilly is on our platform, has a similar high sensitivity, specificity over 90% and an 18% indeterminate zone, so fairly accurate. So those are kind of our 2 tests. There have been a handful of other tests that have come out in the market over the last several months. What's interesting and unique about this is, firstly, the level of data that we have published in relation to others. We've been working on this for several years now. We have a very robust body of work and several clinical trials that back up everything that we've put out so far. The data available on the other test is relatively limited. And therefore, there's definitely questions about how useful they would be in a clinical setting. That's an incredibly important part of this. But the other piece that's really important, which again got highlighted in the Lilly AdCom really is that importance of early detection. At a later stage in the disease, when you know you have the disease and it's progressing already, there are several tests that will be able to detect the prevalence of the disease through blood. At that point in time, you're already pretty far along the disease continuum, so it's not really telling you too much. What's unique about our test is because of our level of ultra-sensitivity, we're able to detect disease much earlier than any of the others. And that's -- there's been a lot of discussion on how sensitive is sensitive enough. Do you really need a level of sensitivity? Late stage, probably not. Early stage or if you want to get on drug at the right time and have the most impact, it really does matter. And that's where we feel like our test is extremely differentiated.

And I tend to think the ultimate arbiter of this competitive discussion will, in some part, be who gets the FDA approval first. And from a data perspective, you've outlined that you have been doing it the longest and have likely the most data. You also have the breakthrough designation, so does another peer as well. But maybe talk about what your expectations are for the timeline for FDA approval? What the breakthrough designation does to help that along? And should -- is it safe to assume that given the level of data you have, given the breakthrough designation, given sort of that you're earlier in the stage, all things considered, and I don't want to try to predict what the FDA will do or not do, but does that give you a potential head start in terms of getting that potential approval first?

Yes. I'll touch on that, and then I did want to expand that a little bit into multi-marker as well. I think that is the other very relevant piece here. So we have been working on this for a while. We are pretty deep in a couple of trials, and we will present more data as the year goes by as well. But we are -- we've received breakthrough designation for our p-Tau 217 test in the beginning of March. And we are working very closely with the FDA on being able to continue to work that and take that through the approval process. Now that will probably take some amount of time. That's probably not a 2024 event, but it's something that we are working pretty closely on. The other thing that's important here is we have a lot of data on 217, and we're working that through the process, and that's definitely given us a head start over our competitors. But really, what we feel is going to be a differentiator versus our competitors is the work we're doing on multi-marker. And for those unfamiliar with it, this is basically where we are measuring multiple biomarkers within the same test. So for now, for example, in addition to 217, we could be measuring GFAP, NfL, Abeta 40, 42, et cetera. And where [Audio Gap]. We have the ability to provide the same level of ultra-sensitivity on multiple markers in the same test. The reason that's important is it provides for a differential diagnosis. So if you're a patient and you go in and you test negative for Alzheimer's, you clearly have some symptoms, which is why you came in, in the first place. If it's not Alzheimer's, where do you go? What's kind of that next step for that patient? That's really where multi-marker becomes incredibly important and provides additional insights that you wouldn't get just from a single marker. So Matt, the way we see this progress is, for now, we're all working on the single marker test. But when you look at what's going to be effective in a clinical setting, we strongly believe that the one-marker test will not be enough, you really need the multi-marker. And for that, again, we've had a body of evidence that's already been presented. We will be at AAIC later this year in July, and we will present additional data. We have about 4 people going in for that, where we'll talk a lot more about how that's progressed. But we really feel like that is the differentiator for us, and that's really where there's a maximum effectiveness of the blood-based test. As a CFO, it's also probably the most attractive from an economics perspective, and that's an important factor as well.

Yes. Can you touch on the economics of multi-marker? I mean I think you guys have said in the past that the COGS of a single-marker test is a little below 100 and the price point is probably 300 to 500. And I've received a lot of questions from investors, and so I have the same questions myself. As you add markers, is that just in equal amount of COGS? I'm sure there's some scalability in that. And then in terms of price, what that does? And I know there's not one on the market. So you can comment as to where you're comfortable talking about it. But I think giving people a sense for what multi-marker does both on the cost side and the price side would be helpful.

Yes. So multi-marker really helps from a revenue perspective. From a cost perspective, it's interesting. The -- when you look at the cost base of a test, there's the cost of the assay itself and then there's all of the collection costs. The collection cost is pretty significant. So the benefit of the multi-marker is it's one collection cost. Even if your assay is a little bit more than a single assay, that's not really the variable that matters. It's the collection cost that really matters. So that's kind of one place where the economics of the multi-marker improve pretty substantially. The other place again is you're providing more insights, more data. And then either through a code stack or an ADLT path, we expect that reimbursement to be significantly higher than the single marker test. So there's clear economies, both on the cost side as well as a multiplier effect on the revenue side.

Got it. And then just shifting gears a little bit. You -- early in the first quarter, you announced the partnership with 5 different health systems, and some of them were pretty impressive health systems as well. I know it's early, and this is early for everybody, not just for the announcement, but also for starting this up. But maybe talk about how those relationships started to trend. Are you seeing any kind of levels of activity? Has this led to other conversations about additional partnerships that you could do to drive the diagnostic business forward?

Sure. So if you take a step back, our approach on diagnostics from a commercial perspective is 2-pronged. One is LucentAD, which is our brand. That's when we perform the test ourselves through our CLIA lab in Boston. The other approach is what we call an enablement network where we enable certain key partners to either perform the test themselves by buying instruments or consumables or do a test sent out to us and we'll perform the test for them. So earlier this year, we announced 5 key partnerships where we are working with certain key health providers to be able to do the testing. I'd say very, very early days in terms of volume, clearly, not material by any level from a volume perspective, but really starting to see good dialogue with them, good traction with them in terms of what they expect. Also really good insights into what is top of mind for neurologists as they're looking at being able to establish this test. We're continuing to work this path. And even as the drug has been delayed, we've been going full steam ahead. And we will announce more partnerships through the course of the year, but it's been good [Audio Gap].

How important is that donanemab approval for those relationships?

Yes, absolutely. It's the approval and then the pace of the uptick of the [indiscernible].

Got it. When you look at sort of the business update you did a little while ago about licensing your exclusive intellectual property, have you seen any incremental demand in regard to the IP following that update?

Yes. So the IP has been very interesting. Without talking about the specifics of any individual party, what that's done for us is it's definitely helped open the aperture for our commercial team as they go talk to potential partners to really have kind of a clear understanding of what the landscape is. And those discussions are going very well. We have a lot of interesting partners that we're talking to, and the intent is to be able to broaden that partner network as much as possible while we wait for drug adoption and uptake.

Got it. And then I was going to ask you about the limitations around PET and CSF based testing for Alzheimer's and how blood-based offering kind of helps open up patient access. But it seemed like the AdCom kind of answered the question on PET, which was -- it seemed to be quite clear. CSF, however, maybe talk about that being sort of, [ I don't say ], share donor, but that's potentially where some of those volumes could shift over to. Like what are you seeing when you talk to sort of practices and health systems about the willingness to use CSF versus blood? From a patient perspective, it's kind of a no-brainer. But from a doctor's perspective, they're looking at a number of different things.

Yes. So from a patient's perspective, certainly, I wouldn't be the one wanting to do a spinal tap and I would much prefer a blood test myself. From a neurologist perspective, for those neurologists that have already been pretty deep in the field, they are really starting to understand the impacts of the blood-based biomarkers and very favorable response from urologists as we talked about. So they're understanding it. They're clearly seeing this as a way to get faster support to patients. So overall, very favorable response from all of them. The cost is also fairly compelling. Even though PET is clearly very expensive, even a CSF as compared to a $300 test or wherever reimbursement falls is still very attractive.

Got it. Obviously, a lot of focus is around therapy selection and monitoring. But you can envision the potential for detection and asymptomatic cohort. I personally feel like you would have to have an FDA approval to approach that market. But it doesn't seem out of bounds when you think that everyone over the age of 65, every number of years, get some type of screening, particularly given the drugs we have today are really most efficacious at the early stages. How do -- how would Quanterix fit into that picture for asymptomatic or testing, again, recognizing this is a long way off?

Yes. And perhaps it's not that long [indiscernible]. I can also envision a state where maybe it's not 65, maybe it's earlier than that you go get your annual physical. You add this as a test when you're doing your blood draw anyway. But for us, really, our mission as a company really has been around early detection of disease. That's been kind of our guiding philosophy. And that's been where because of our level of sensitivity, we are able to work through and detect disease in asymptomatic patients long before that really becomes prevalent. So for us, kind of our vision or the way we would love to see this fold out is that it's part of your standard annual physical where as you come in for a physical, you also get this tested when you do your blood draw. That gets you a really early start, whether it's in terms of drug or whether it's in terms of lifestyle changes or whatever it is that's needed to be able to prevent a disease.

One thing I wanted to ask you about is sort of going back to the multi-marker discussion that we recently had. It seems to me that at times the pivot from one biomarker to the next happens very abruptly, and then everyone rushes in. And the one thing that I don't think people understand about Quanterix is all the work that you've done in the RUO channel with pharma partners working on different biomarkers gives you this repository of biomarkers that I think makes it -- and correct me if we're wrong, but I think it makes you more flexible, and it gives you the ability to pivot to add additional biomarkers. Now the data and the validation, that takes time, but that takes -- that [ gives ] every one time. But like talk a little bit about sort of your ability to pivot if new biomarkers do come out and say, this one actually is more valuable. Right now, 217's having a moment, but it could be something else later.

Yes. That's a really interesting point, and it's something that you don't appreciate and you kind of lived through this a few times. It's not -- it's -- firstly, the pivot is an important piece of it. The other piece of it is just knowing what's out there in terms of detection. And that's where our Accelerator Lab has been really unique. So just to kind of pull on the example of 217. The way 217 played out and the reason we were so quick to respond on 217 was, we had been working with a pharma partner for several years as they were in that very early discovery cycle. So we started several years before others did because we were working with that pharma partner in that super exploratory phase, which then turned into a clinical trial, which then turn into an assay. So we kind of -- we were with them throughout that entire process. And that's the reason why we were ready when the guidelines changed, and we had already done the vast body of work that was required when this came along. So that's why Accelerator is unique in that it helps to give us those insights very early. And then as those insights come in, we are able to respond very quickly. In the last earnings call, we had talked about BD-tau, for example, which is another very similar example. So BD-tau is brain derived tau. So it's -- the protein comes directly from the brain, which means it is a lot less diluted than 217 or other tau. So very early days right now, but we're very excited about that because we feel like that might open the key to other discoveries and other insights that could be very useful and unique. So we are kind of in this constant development cycle where we continuously are looking at what's important from a research perspective and then able to very quickly turn that into a product.

And there's so much focus on Alzheimer's. And I think me and my team are maybe partly to blame for that. So -- but there's obviously a host of other neurological disorders that you guys have spent time on. Maybe just for the audience, just talk a little bit about what -- outside of Alzheimer's, what other areas have you guys been working on?

Yes. So neurology is about 80% of our business. The rest of the 20% is broadly, I'd say, immunology and a few others, but really 80% of our business is focused on neurology. Alzheimer's is clearly a huge focus for us. The other areas that we're seeing a lot of interest in is Parkinson's, for sure. So that's an area that we're spending a lot of time on. We're very involved in a couple of key foundations and doing a lot of work with them to advance over there. Frontotemporal dementia is another one that is getting a lot of interest, traumatic brain injury. So quite a few of these others, but I think close after Alzheimer's, Parkinson's is going to be another one that has tremendous interest. In addition to that, we mentioned earlier in the year that we are also looking at the plexity of our instrument because what we're also starting to look at is beyond neurology, how do we go deeper into immunology. So a couple of things that we're doing there. One is, as we introduce new assays, there will be a couple of immunology-specific assays that will come out later this year, which will start to broaden what we know over there. And then we're continuing to work on the instrument to see how we can perhaps amend the plexity to go slightly further up, go more than 4 to 5 plex to perhaps 2 to 3x that and see if that helps us on the immunology front.

Got it. Turning more into financials in the business. You guys underwent a pretty significant restructuring and completed your assay redevelopment program at the end of last year. Maybe just talk about some of the advantages that you're seeing either in throughput, capacity, potential margins or operating leverage when it comes to restructuring your cost base that you feel like you've now achieved post all of that restructuring that's taking place?

Yes. So in the mid-'22 time frame, we reached the position as a company where while we were growing, call it, high double-digit, 30%, 40% a year, margins weren't really expanding, and we really weren't able to scale. So we kind of called a time out, did an 18-month transformation, which initially started with a fairly deep restructuring. We restructured our entire cost base and then really started to double down and focus on our manufacturing processes. And what we did through that was we basically improved the quality of our assays. We improved things like the cycle time. We improved the shelf life of the assays, and really kind of made manufacturing more consistent versus really being variable. So coming out of that 18-month transformation, which ended in December last year, what we saw were a few very clear tangible benefits. The first was really around size and scale. So we now have the ability to do upward of 4 million assays. So our throughput has increased almost 300%. We can now -- there was about a 50% improvement in our testing capability at the same time. So clearly, like huge amount of leverage that we gained from that piece of the process. Perhaps more importantly, it also set us up as an innovation company again. Our product development engine during this time had pretty much stalled. We hadn't put out any new products or had any major breakthroughs because we were just basically dealing with the day to day. We have now brought it to where we have the ability to turn assays through that development cycle relatively quickly and get them to market really quickly. We did 5 new assays in the first quarter of last year. And for the remainder of the year, we expect to do another 15. And that really wouldn't have been possible without taking some of the hard steps that we had to take in the transformation. And where it all, everything eventually has to come in line in the financials, and that's why we're really starting to see that impact our margins. When we started the transformation in the second quarter of 2022, our gross margin was at 29%. When we ended the first quarter, this quarter, our non-GAAP gross margins were 54.5%. So really tangible improvement in gross margins, and that's really kind of the real test of whether the transformation worked or not.

And then can you just talk a little bit about the path to profitability? You have a very strong balance sheet with no real concerns. You've reduced your burn significantly. Maybe talk about sort of what is the path to profitability? What are your long-term margin goals?

Yes. So when we look at profitability and to some extent, capital allocation as well, we look at it in terms of what's happening in the base RUO business and then where is our investment going. So in terms of the base RUO business, the path is incredibly clear. We think we have the right foundation now to really to be able to build off. So this is really going to be all about volume leverage and continuing to very responsibly drive cost improvements. So the way we've looked at our progression on gross margin, that's given us a lot of comfort that as we get to a revenue range of about $170 million to $190 million, there should be a clear path to getting to breakeven. Just for context, this year, our guide is between $139 million to $144 million. So that breakeven point is not this year, but it's the end of insight, so to speak, we can kind of see a line of sight to that. We feel like we're relatively well capitalized from an SG&A perspective. So we feel like we've got the right baseline, and we'll continue to be very disciplined about what we do there. At the same time, we are, however, extremely focused on R&D and innovation. I talked about the fact that we're working instrument, we're working assay development. We're continuing to work what -- the diagnostics field and what it takes to get it through FDA approvals, et cetera. So while we'll continue to reduce our cash burn on the RUO side, we will also continue to push investment and responsibly use our balance sheet to be able to drive to these strategic practices.

In Q4 of last year, you talked about $20 million in additional investments over the course of this year. Some of that's going to menu expansion, some of that's going to LucentAD. It seems like it's focused on the diagnostics side of the business if I had to characterize it. Could you talk about sort of within that, how much is going to LucentAD? How much is going to building out commercial partnerships with diagnostic labs or health systems? Just kind of give us a flavor for where that $20 million is going towards.

Yes. So that $20 million, I'd say, is probably, call it, 50%, 60% diagnostics, but the rest really is in the RUO business. And that RUO piece is really the investment in instrument and in assay development. So very clear cut, very direct correlation to revenue, we continue to work that. On the diagnostics front, the [Audio Gap] front, but there is still a fairly significant expense in terms of taking everything through FDA. So we're continuing to work the studies that are supporting our FDA submission, continuing to work that process as well. So there's some cost for that. But then the bulk of it really is on the commercial side. We basically stood up a brand-new commercial team that is extremely focused on diagnostics. We're trying to make sure we have a good sense of responsibility and good line of sight into what that team is doing. So that seems off to a really good start. They've really started to close partnerships as well, and it's going exactly as we expected it to.

Okay. And then just -- you talked about the FDA submission. Can you just give us a sense of timeline when you're expecting to do that?

Yes. So we expect to have something ready towards the end of the year, in the later part of the year. And we expect that to take some time, but we have all of the right studies in place right now and those are progressing well for now.

Great. Well, I think we're just about out of time. So with that, I'll leave it. Thank you guys very much. Really appreciate it.

Thank you.