Quanterix Corporation

Good day, and thank you for standing by. Welcome to the Quantrix Corporation Q3 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Ed Joyce. Please go ahead.

Thank you, Hope, and good morning. With me on today's call is Masood Salu, President and CEO of Quantarix, and Vandana Sriram, our Chief Financial Officer. Vandana joined us in August as Mike Doyle transitions into retirement in early 2024. Before we begin, I would like to remind you of a few things. The call will be recorded and a replay will be available on the investor resources section of our website. Today's call will contain forward-looking statements within the meaning of the US Private Securities Litigation Reform Act. These forward-looking statements are based on management's beliefs and assumptions and on information available as of the date of this call. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, assumptions, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statement. The risks and uncertainties that we face are described in our most recent filings with the Securities and Exchange Commission. To supplement the company's financial statements presented on a GAAP basis, the company has provided certain non-GAAP financial measures. Management uses these non-GAAP measures to evaluate operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. The company believes that such measures are important in comparing current results with other period results and are useful in assessing the company's operating performance. The non-GAAP financial performance information presented here should be considered in conjunction with and not as a substitute for the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth in the appendix of the presentation posted to our website and in the earnings release issued today. I'll now turn the call over to Masoud.

Thanks, Ed. Good morning, everyone, and thank you for joining us on our third quarter call. We're pleased to announce the six-quarter transformation plan we laid out last year is expected to be substantially complete by year end. with assays rolling off our new scalable production platform in January. Incremental improvements made throughout this year have been positively reflected in our financial results and continue to do so in the third quarter, with year-over-year revenue up 18% to $31.3 million, non-GAAP gross margin improving 1,300 basis points to 48.6%, and disciplined cash use going from over 17 million for the corresponding prior year period to under 2 million this quarter. On the foundation of this new ops platform, we will continue to improve gross margins and take our research business from one that's burning cash to one that's generating it. We'll deploy capital to first, expand access to our platform, and second, enable patient testing with new biomarker solutions we've recently developed. Samoa continues to be the leader in measuring proteins at the lowest detectable levels, and as we said at the beginning of this year, our goals are ubiquity, such that Samoa is not limited to just specialty labs, but accessible by all labs. This means additional biomarker diversity and instrument utility that ensures broad reach. We spoke a lot this year about improving operating scale and margins. In 24, we're going to talk a lot about increasing innovation rate, a metric we're going to measure ourselves by. Last month at the clinical trial for the Alzheimer's disease CTAD meeting, Samoa-based blood biomarkers testing was revealed in several neuroclinical trials for monitoring, measuring efficacy of neurotherapies and diagnostics. Samoa's ultra-sensitive digital immunoassay technology delivers scaled, high-throughput measurement of neurodegenerative blood biomarkers, including those for Alzheimer's disease. Of these presentations, Eli Lilly presented analytical validation and clinical performance of a PTAL217 blood-based diagnostic test to identify amyloid PET positivity using the Samoa platform. Their study included over 1,000 samples and was run over multiple lots, operators, and Samoa instruments. The study demonstrated high correlation of pTau217 to amyloid PET with an area under the curve of 91.6%. Samoa's ultrasensitivity translates to very low limit of quantitation necessary for blood biomarkers like pTau217. The VUMC Medical Center in Amsterdam presented phase one data highlighting the potential for differential diagnosis of Alzheimer's disease and dementia. Recall, we are working with the VUMC and ADDF on a clinical trial to support the diagnosis of Alzheimer's and determine through a multimodal algorithm threshold levels of key blood-based biomarkers to differentiate other forms of dementia, such as frontal lobe or Lewy bodies. Early data suggests that the combination of P tau and NFL measurements can aid in discerning frontal temporal dementia from Alzheimer's disease with an area under the curve of 0.87. While there's much more work to be done in this study, including work at multicenter clinical trial sites, the early insights are promising. Reported in Nature Medicine in July, a 1,000 plus participant study examined why certain amyloid positive patients without cognitive impairment do not develop tau pathology. RSMO platform was used to look at astrocyte reactivity by measuring GFAP levels in blood. The study led by researchers at the University of Pittsburgh found astrocyte reactivity influenced A-beta effects on tau pathology in preclinical Alzheimer's disease. Now these studies emphasize Two critical points. First, there's a lot more work left to be done with this terrible disease, and we believe we're entering a decade where significant effort and capital will be invested in research and clinical trials for Alzheimer's. Second, we're in the early innings of treatment where there will be a focus on screening and diagnostics, expanding into prognosis and disease staging, both of which will require precise blood-based biomarkers at the highest levels of sensitivity. As an indication of the future, and based on what we're observing with the latest results, trials, and research, it will be multiple neural blood biomarkers measured together that will tell the whole story. Finally, I'm happy to report that a few weeks ago, we signed a new agreement with Johnson & Johnson Innovative Medicines and launched the LUCIN-AD pTau217 blood-based biomarker test, combining Quanterix ultra-sensitivity Samoa technology and J&J's pTau217 antibodies to provide high-accuracy Alzheimer's disease testing. pTau217 levels can become elevated in very early stages of the Alzheimer's disease continuum well before symptoms rise. Our pTau217 test achieved sensitivity, specificity, and an overall accuracy each exceeding 90%, meeting the criteria outlined in the revised National Institute of Aging and Alzheimer's Association, NIAAA, criteria for diagnosis and staging of the disease. These guidelines are important because the performance criteria for a diagnostic use case with a blood test was defined for the first time, with PTAL217 being the only plasma biomarker appropriate for accurately diagnosing amyloid pathology. This validates the use of fluid-based biomarkers and puts it on the same playing field as the historical standard of PET imaging. We believe we're in a strong position to capitalize on these opportunities from supporting clinical trials to use in diagnosis. With the simplicity of our sample-to-answer system, and the number of new biomarker discoveries happening on our platform, we're in a great position to maintain a long-term leadership role. Now, I'll turn the call over to Vandana to cover our financial results.

Thank you, Masood. Good morning. First, let me start by saying that I'm thrilled to be part of the Quanterix team. It's a really exciting time to be here, and after a couple of months in the role, and even more impressed with our technology and its potential. Today I'll take you through our third quarter results and an update on our guidance for 2023. Our total revenue for the third quarter 2023 was $31.3 million, an increase of 18% from the third quarter of 2022. Our instrument revenue was $3.7 million, a decline of 53% over the third quarter of 2022, and up slightly versus the prior quarter. Consistent with prior quarters and in line with our peers, we continued to see CapEx constraints impacting the timing of instrument sales, a trend we expect will continue in the fourth quarter. Our consumables revenue increased to $16.2 million, or 63%, compared to third quarter of last year. This speaks to the strength of our installed base, as well as the improvements in our manufacturing processes as we were able to catch up with demand. Revenue from our accelerator lab was 6.2 million, more than double over the third quarter of 2022. Our accelerator services continue to be a valuable and differentiated offering and have been especially effective in providing customers an alternative to continue their projects in the current funding environment. Now let's move on to gross margin for the quarter. Our GAAP gross profit and margin was 17.8 million and 56.8% for the third quarter of 2023, compared to 10.9 million and 41.1% in the third quarter of 2022. Non-GAAP gross profit and margin was 15.2 million and 48.6% in the quarter, as compared to 9.3 million and 34.9% in the third quarter of last year. Our corporate transformation has enabled us to reduce inventory losses and drive efficiencies in our processes, and this is evident in our gross margin performance. Our third quarter gap operating expenses were $31.6 million compared to $47.5 million in the third quarter of 2022. Excluding the impact of one-time impairment charges of $20.3 million in the third quarter of 2022, gap operating expenses increased 16% and non-gap operating expenses were up 13%, primarily due to higher consulting fees and personnel costs. Our net loss declined from 35.1 million in the third quarter of 2022 to 7.8 million in the third quarter of 2023 due to improved margins from our redevelopment program, the absence of the impairments from 2022, as well as higher interest and other income. Moving on to liquidity, We ended the third quarter with $330.4 million in total cash and equivalents, a net usage of $1.9 million during the quarter, as compared to cash burn of $17.6 million in the third quarter of 2022. Our efficiency gains have translated to significantly reduced year-over-year cash burn. Turning to guidance now for the fourth quarter and full year of 2023. As Masood mentioned, we've made great progress with our redevelopment efforts and are in the last of the six-quarter transformation process. For the fourth quarter, we will be focused on upgrades and readiness of our production lines as we introduce new assays in 2024 and in executing on the final steps of our transformation. With these objectives in mind, we expect our fourth quarter revenue to be between 27 and 29 million. This increases our revenue guidance for the year to be in the range of 118 to 120 million compared to our previous range of 110 to 116 million. We are also increasing our gross margin expectations for the year and now anticipate GAAP gross margin percent to be in the high 50s and non-GAAP gross margin percent to be approximately 50%. As we implement the upgrades to our production processes, we expect non-GAAP gross margins to be in the mid 40s for the fourth quarter, slightly lower than past quarters, to account for potential higher costs from these transitional changes. Lastly, we now expect our cash usage for the full year to be in the range of 20 to 25 million, and improvement from our prior estimate range of 30 to 35 million. We expect higher cash outflow in the fourth quarter due to the timing of certain initiatives and payments. For the year, this reflects a significant improvement in cash burn over 2022. Our increased guidance across all our key metrics reflects the continued strong demand for our Samoa technology, and our execution against our transformation goals. Our balance sheet remains strong, and we are well positioned to support our growth and strategic initiatives. I will now turn it back over to Masood before we take your questions. Masood?

Thanks, Vandana. I want to copiously thank the entire Quanterix team for their hard work and focused effort. Dan, our COO, and Darren, our CCO, have been relentless in this pursuit. And as a result, there's been remarkable progress in building a solid and scaled operations platform for existing products and developing the engine for new product releases to come. If you can't tell, we're super excited about next year. Let's take some questions now.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1-1 and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from Kyle Mixon with Canna Accord Gentuity. Please go ahead.

Yeah, hey guys, thanks for taking the questions. Congrats on the progress here. Just starting off with the new PTAS 217 agreement with Janssen, I had a few questions about that. First in the suit, could you talk about deal economics? I think with Lilly, you know, a year and a half ago, that was about $11 million in accelerator revenue for like about a full year or so. Curious if there's a comparison here. And then this agreement, like was it brought on by any change in the relationship with Lilly and does Lilly remain, you know, an important partner for you going forward? And maybe just one clarification, will Lilly be using Samoa for its own Alzheimer's test because the company is working with other like analyzer and assay vendors as well? So I'm just, you know, get the question a lot about that. Thanks. Yeah. Thanks, Kyle.

Yeah, so the answer to your first question, we haven't announced any sort of deal economics on the J&J agreement that we signed. However, you know, I would say that Quantirix expects the majority of the economics to come from our LDT and our kit sales and what we're doing in the market and trying to get 217 into a lot of folks' hands. To your second question, I think it was on the broad use of 217. Our view on 217 is that we want to try to get it into as many hands as possible. We think that our collaboration with Lilly continues, and it's a very strong collaboration. They presented some great data at CTAD on the CMO platform, and so we expect that relationship to continue. And then on our LDT, it is using the J&J solution, but we want to make both solutions available to this market. And I think you had a third question. I might have missed it there, Kyle.

Yeah, so far so good. Lily has its own Alzheimer's assay, right? Is that going to be based on SOMO or some other analyzer assay vendor?

Yeah, so I think there was some clarity at the CTAD meeting. There was a strong analytical and early clinical validation of the SOMO platform in 2017. you know, view this is there's a lot of different types of solutions and platforms in the market for Alzheimer's detection. We're one of the more sensitive ones around 217 and, you know, I expect our efforts and cooperation to continue.

Okay, that was perfect. Thanks for that. And it was good to see the NIAAA guidelines, you know, I guess like the new recommendations recently. I was curious how influential those are to clinicians in terms of going against the grain and kind of ordering with these novel products, sort of like these tests that we're talking about here. And how could those guidelines, if finalized, impact CMS decisions regarding reimbursement as well? Like, is that a key question, you know, given this class of tests are still pretty early days?

Yeah, we agree with that, Kyle. I think it was nice to see the NIAAA guidelines and criteria and And, you know, I think the, while it's not a direct, a clinical recommendation, I think it has a big influence, and to your point, could affect further decisions down the road. And, you know, I really, you know, totally agree with what came out from the guidelines. One, in terms of a blood test, two, if it's going to be a blood test that's on the same playing field as PET, you know, 217 was a clear answer there. And we've been working on this, obviously, with our partners for years. And the data has been pretty strong through the clinical trials. And then two, if you look at the accuracy that's required in blood, it was high. And the sensitivity required is high. And so I applaud the organization for really picking a great test and great marker for diagnosis.

Perfect. One more before I hop off. Just on the P&L, I guess as you kind of break out revenue, you guys have a lot of one-time items. If you parse those out, product revenue was a little bit softer than service. Service was quite strong. Product has the macro headwinds in there, but instruments declined a lot year-over-year this quarter, but it is down, I think, 37% year-to-date. So that's not just due to the recent CapEx constraints. Maybe... you know, I guess why, I mean, recognizing that overall revenue has been solid and you have this program going, why has product revenue been relatively soft and particularly instruments recently? And then for how much longer would you rely on kind of the service and accelerator revenue to drive growth?

Yeah, maybe I'll start with that. And then Vandana, if you have additional color, well, first, first I would say that we do think that, you know, some of the instrument softness, um, at least more recently, has been CapEx-constrained, CapEx-related, and that has transferred to our accelerator program where people can do services. I'd say that what you saw this year with our redevelopment program was really building a platform. If you think back, say, four or five quarters, when we announced the program and we built that quality wall, we added, you know, made sure things going out the door were going to be, you know, things that are going to be scalable at the highest level of quality. And so throughout the year, there's always going to be a year of focus on our products and getting them at the highest level to customers. So some back and forth. But overall, the consumables are going out the door to our customers. The utility and usage on a per platform basis is good. And as you can see, a lot of folks want to come and use our program, our accelerator program, to run these trials. So we don't see any softening on demand and desire using this ML platform, and nor do we see it in the area that we're in.

Yeah, I just add, within product revenue, if you're combining instruments and consumables, consumables are actually up 63% year-over-year and up 7% sequentially. We're very pleased with the momentum we're seeing on consumables. Some of this was a catch up on demand as we streamlined our processes. Instruments, as you pointed out, we continue to struggle with the overhang of the macro. We saw a little bit of sequential improvement this quarter. We were up about 5%, one extra instrument. But we do expect, as this overhang on instruments continues, we do expect to continue to see volume come through the accelerator, which is helping to soften and balance that out for us.

Okay, and what was the catch up for consumables that was like super helpful just to catch up is if you can quantify that, you know, we're gonna get questions like that, too. Thanks.

Yeah, I'm not sure we can quantify it in dollar terms. But if you just look at our sequential improvement, you know, we've we've had about 15 to last quarter, we went up about a million this quarter, all of these have a little bit of just catching up on pent up demand. You know, our team is now at a point where we are mostly caught up with orders that we couldn't fulfill. And we're now kind of back on a steady state.

Awesome. Okay. Well, thanks a lot, guys. Appreciate the time. Thanks, Bill.

Thank you. One moment for our next question. Our next question comes from Matthew Sykes with Goldman Sachs. Please go ahead.

Hi. This is Jake Allen on for Matt Sykes. Thank you for taking our questions. I'll ask both my questions up front. First, could you give us an update into the timing of FDA filing and approval for Lucid AD and the IVD pathway for a broader menu of biomarker tests? And then additionally, how should we be thinking about the longer term gross margin profile for the business, given the progress that you have made on margin expansion, which is trended ahead of expectations? Thank you.

Hey, Jake. So I'll take your first question. The FDA, I mean, we've always said you know, our strategy as an organization is to ensure that we're getting these tests out there as early and as fast as we can. And so that mechanism has been through our CLIA CAP certified laboratory here in Boston. And so that's the start. We've also believed that these tests should also go through FDA approval. And our plan is to do that, you know, within next several quarters and make sure we have a submission on our 217 to the FDA. And then in terms of timing, you know, that can take, you know, some time. Of course, it depends on the agency. But in the meantime, you know, we think getting testing done through the CAP CLIA lab is going to be important.

Yeah, and on growth margins, let me address near-term expectations, and then I'll talk a little bit about the longer-term as well. Near-term I'd say our gross margin performance this quarter exceeded where we expected we would be. We had signals to an early mid-40s number for the quarter, and we did much better than that, partly because of volume, partly because of our improvements. We see a similar trend going into the fourth quarter, but we do expect some amount of margin headwind as we implement all of our production changes. Longer term, however, we've previously guided to wanting to accomplish margins in the 60s, in the early 60s, we continue to work towards that. There's obviously a lot of factors that'll impact that, product mix being a significant part of that, as well as timing of how quickly some of our production processes start to spin out the new assays. Got it.

Thank you, guys, and congrats on the continued progress. Thanks, Jake.

Thank you. One moment for our next question. Our next question is from Dan Brennan with Cohen. Your line is now open.

Hey, good morning. Thank you for taking the questions. Maybe the first one just on the guidance. You've had some really good success here year to date. Just wondering on the fourth quarter kind of implied guide, it looks very conservative in light of kind of what you've done year to date compared to what you did in 2022. So I'm just wondering, can you give us a little color on how should we be thinking about that fourth quarter guide. And then you know, if we if we cycle past the fourth quarter, are we still thinking double digit growth expectation with 24? Does any early read there?

Yeah, thanks for the question, Dan. So you know, for the fourth quarter, as Masood and I mentioned earlier, we are going to be hyper focused on implementing the last stages of our transformation, standing up our second production line, and having assays on the shelf for 2024. So with that in mind, that's going to impact the velocity at which our consumables go out. On the other hand, for instruments, you still have the macro overhang that others have talked about, which is unpredictable and hard for us to get good line of sight on. So keeping those in mind, also keeping in fact that the fourth quarter has less working days, which impacts the services businesses, we basically try to balance out our guides to a reasonable number. With that said, we continue to work towards the double-digit number for next year. As we get into the February quarter, we'll start to size that up more and define that a little bit more. But for now, definitely expecting the fourth quarter to have some of these headwinds and planning for that.

Got it. And then maybe just one on kind of Alzheimer's. How should we be thinking about the sensitivity and specificity of a blood-based test as compared to PET when we think about both rule-out and rule in? And then B, how should we think about timing for Medicare coverage on the various kind of tests that you're looking to implement?

Yeah, Dan. So on the Alzheimer's side, I think what we saw in the guidelines, I would sort of direct folks to the NIAAA guidelines. And there, it was very clear that a test would need an accuracy that's above 90%. And when we did this, we did two two studies. One was the Amsterdam Dementia Cohort. Around 500 individuals were tested. And then we also looked at the BioHermes trial, which was a multi-center site, 17 U.S. clinical sites. And in both large studies, we were able to achieve accuracies that are above 90 percent, which is the guideline or the criterion in the draft NIAAA. Very happy about that. And I think that's going to be the case for any sort of test that wants to try to be on the same playing field as PET. And then your second question was on timing of reimbursement. Was that the question? Yeah, yes, yes. It was on Medicare. How do we think the pathway forward for Medicare? Yeah, so I expect the Medicare path maybe initially will, you know, be laid out either by local coverage determination or maybe in the next year or so as this becomes more and more important and in the hands of neurologists and people performing testing, that it becomes potentially an NCD in the future. Hard to say from a timing perspective, but we hope that it gets the attention it deserves.

Great. Thank you, Masoud. Thanks, Dan.

Thank you. One moment for our next question. Our next question comes from Puneet Sudha with LeRinc Partners. Your line is open.

Hey, Masood. Yeah, thanks for taking the question. So the first one maybe, and I don't know if this was covered, but, you know, there was a discussion of two-cut assay to drive performance improvement at CTAD. Can you maybe just talk about that, if the P-tau assay is structured that way, and sort of what's the performance level that we should expect here? There was also quite a bit of discussion on, you know, the performance that would be needed to, you know, deliver on P-tau 217, where obviously Simoa has done well historically. So maybe can you just talk about, you know, how Simoa's position –

products that are... Hey, Puneet, can you hear me? You got cut off there at the end, but I got the first part of the question.

Yeah, just if you could also talk about reference labs competition too. I mean, what do you think about that? Thank you.

Yep. So, as I said, we looked at two different sample cohorts, two large sample cohorts. And I think when you start to look at blood test that's going to be on the same playing field or could be the diagnostic test meaning you know something at the rule in or rule out you you you're obviously doing it some comparator either CSF or pet and there the two cutoff approach isn't you know incredibly be important so we use the two cutoff approach it was recommended by the draft NIA a guidelines And it basically establishes a three-zone test and reflects low, intermediate, and high risk of amyloid pathology. So samples reading below the cutoff are unlikely to have the pathology, and then samples reading above the upper cutoff are likely to have that pathology. And so I think that as we move forward, that becomes more and more the type of test that would be used if you're not going to be doing imaging or CSF. You know, in terms of the sensitivity required, the guidelines, you know, the requirement is above 90% accuracy. Our assay had the sense and spec and accuracy in both cohorts, so that was incredibly promising. And I just want to, you know, remind folks that, you know, it's measuring the PTAL217 effectively in blood, getting the femtogram per milliliter sensitivity, and then doing it in clinical samples where, You're looking at, you know, patients that are early stage subjective cognitive decline, mild cognitive decline, Alzheimer's, dementia. That's a broad range. And if you want a test that's going to be able to effectively measure folks in the early stages of cognitive decline or, you know, in the future pre-symptoms, you want a test that has the highest sensitivity that's going to be broad-based for patients at all ends of the spectrum. And so, you know, I think based on these guidelines and some of the things that, you know, data that we're seeing, not all tests and not all platforms are going to be able to do that. And we're happy that the Samoa and the 217 platform will be able to cover the broadest range of patients.

Got it. Super helpful. And then just wanted to, you know, clarify, obviously you had the launch of 217, but just sort of the timing for, the multiplex and sort of how do you think additions to that 217 additional biomarkers with that 217 are required, or do you think 217, given the significance of this biomarker, is now sort of adequate enough for the field?

Good question. There was some of that discussion at the CTAD meeting, and I think One thing I just want to make very clear is that, you know, 217 is very important for diagnosis, and that has been well established, based on what I said earlier. But I also want to make clear that this is an evolving field where prognosis, staging, differential diagnosis are all going to be important. You know, it's not, you know, one patient comes in, they're diagnosed, and that's it. There's treatment monitoring. Following on the patient and what we're seeing if you look at the latest clinical trials and and the research It's going to likely be several Multi marker tests and and the sensitivity Required for each of those biomarkers is going to be high and so having a platform where you have wide bandwidth wide sensitivity bandwidth to be able to measure a tau at the same time as you're measuring a a beta or a GFAP or NFL on the same run, same patient sample is going to be incredibly important. And so, you know, I think you're right, 217 is the single marker for diagnosis. I think it can be enhanced with multi-markers and then staging measurement of a patient over a period of time and the prognosis is likely to be multi-marker based. Got it. Okay, thank you. Thanks, Bonita.

Thank you. One moment for our next question. Our next question comes from Kyle Mixon with Canaccord Genuity. Please go ahead.

Yeah, thanks for the follow-up, guys. So on 2024, if you analyze this fourth quarter guidance, like the full year revenue for next year, which is in line with this year's levels, obviously if the macro improves in the Like, you know, this fourth quarter run could be kind of conservative. But, you know, it sounds like the rollout of these new skews of assays could create some noise and possibly growing pains next year as well. So there's kind of a lot going on. So can you just kind of walk through the main swing factors that could get you to, like, above or below the double-digit growth target for next year? And then maybe any thoughts on cash usage in 2024 as well would be helpful, too. Thanks.

I'll give a broad stroke there, Carl, on sort of the operational efforts, and then Vandana can comment on some of the margin and cash. So what we're doing right now in Q3 and Q4 is really focusing a lot of our resources on upgrades of the product line in preparation for the new assay deployments. We believe, and as you can see in the last several quarters, that these new asset deployments are going to be gross margin and creative. Now, while we're putting them into the line in Q3 and Q4, that's a lot of effort and a lot of focus from the team. But we expect those new product lines, as we've been investing in the last six quarters, will be positive for the business and we'll be able to get those products to our customers in an efficient way and a lot faster. So we're bullish. on that aspect of getting this there. And as I said in the very beginning of the prepared remarks, we have substantially completed a lot of the heavy lifting and we're going to be now doing implementation in the last couple of quarters. So that's that. And then on the guidance for next year, I think just similar to what Vandana said, we're going to talk about that in February and we'll have a better sense. But we still have a strong view that our research business continues to be strong and that we're seeing that continued Samoa demand for sensitivity and for our platforms and solutions.

Yeah, I'd say very consistent with everything Masood said. We do expect 2024 to come in with a position of strength and for us to be able to keep building off that. On the cash side, the only other thing that I would add is, as Masood mentioned in his prepared remarks, The way we think about the business is we will continue to drive the REO business to more and more efficiency, better performance, working better with our customers. So we'll continue to focus on that, and we'll continue to drive it towards getting to cash flow breakeven. We've previously guided to that 170 to 190 number for cash flow breakeven, and we'll continue to work towards that. At the same time, we will deploy some capital into diagnostics. You know, right now it's really small and right now it's really more focused on building out our infrastructure. But you will see us be very focused in where we deploy our capital and making sure that aligns to our strategy.

Okay, that was great. And just one last one. Masood, as we stack up all these options in Alzheimer's diagnostics, Quintero clearly has the most sensitive tests. I think 2017 kind of, you know, helped out with specificity, which I think is what will ultimately lead to that kind of rule-in type test for maybe screening. But How do you think about, like, what's the clinically meaningful sensitivity level for neurology biomarkers? And then on that note, like, what type of tests would be best positioned as a monitoring test in AD? Like, would the number of markers or the levels of some of these metrics matter for that type of a product rather than the one you've already announced to loosen AD?

Yeah, great question, Kyle. You know, the sensitivity, I would expect, you know, a good test to have a sensitivity of 90% and above. So that's, I think, a threshold. Greater than 90% accuracy, and to your point, strong specificity if it's going to be a real end test. So I think that's important for diagnostic. And then in terms of monitoring, staging, monitoring, first, I believe that a tau marker is in that multiplex for monitoring and staging. But we also are seeing the importance of NFL, GFAP, and a few sort of new types of tau variants that we've been doing a lot of work on in our pipeline. So from a monitoring perspective, I could see it being multi-marker. And then, you know, differential diagnosis. Let's also consider that there are folks coming in to the neurologist's office And there are the signs of dementia, but we're not seeing the amyloid pathology. Then what? What is that? And there I think the need for differential diagnosis is important. And there you'll for sure need additional markers beyond tau to be able to provide that differential diagnosis. So we're working with several partners. We're in a few clinical trials that are looking at this, including our own. where we're looking at a broad-based patient set in a multi-marker setting. And I think the point of all of this is 217 is great, and it's, you know, we believe the best marker for the diagnosis, but there's still a lot of work to do, Kyle, in research, in discovery, additional clinical work and testing for what's a much larger picture. And if you sort of look and squint at Kyle Bruursema, You know what we're seeing in the field and what's coming out from industry industry publications it's going to be a multi marker test that's going to require sensitivity for all the markers to be able to tell a whole picture.

Kyle Bruursema, got it okay it's perfect thanks for suit thanks guys. Thanks go.

Thank you. This does conclude the question and answer session. Thank you for your participation in today's conference. This concludes our program. You may now disconnect.