Good day and thank you for standing by. Welcome to the Quanterix Corporation Q3 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] 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 Masoud Toloue President and CEO of Quanterix and Vandana Sriram, Chief Financial Officer. Vandana joined us in August as Mike Doyle transitions into retirement in early 2024. Before we begin, I'd like to remind you of a few things. The call will be recorded and 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 the 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 statements. 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 to comparing current results to the other period results and are useful in assessing the company's operating performance. The non-GAAP financial 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. With that, I'll turn the call over to Masoud.

Thank you, 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. Simoa 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 Simoa is not limited to just specialty labs, but accessible by all labs. This means additional biomarker diversity, instrument utility that ensures broad reach. We spoke a lot this year about improving operating scale and margins. In 2024, 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 Alzheimer's disease, CTAD Meeting, small-based blood biomarkers testing was revealed in several neuro clinical trials for monitoring, measuring efficacy of neuro therapies, and diagnostics. Simoa's ultra-sensitive digital immunoassay technology delivers scaled high throughput measurements of neurodegenerative blood biomarkers including those for Alzheimer's disease.…

Thank you, Masoud. 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, I'm 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% in 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…

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 our 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.

Yes. Hey, guys. Thanks for taking the questions. Congrats on the progress here. Just starting off with the new P-tau217 agreement with Johnson, had a few questions about that. First, Masoud, can you talk about deal economics? I think with Lilly, year and a half ago, that was about $11 million in accelerated revenue for like about a full year. 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 really remain an important partner for you going forward? And then maybe just one clarification. Will Lilly be using Simoa for its own Alzheimer's test because the company is working with other like analyzer and assay vendors as well? So, I'm just get the question [Indiscernible]? Thanks.

Yes. Thanks Kyle. Yes. So, the answer to your first question, we haven't announced any sort of deal economics on the a J&J agreement that we signed. However, I would say that Quanterix expects majority of the economics to come from our LDT and our kit sales and what we're doing with -- in the market and trying to get 217 into a lot of folks' hands. To your 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 we -- our collaboration with Lilly continues and it's a very strong collaboration. They presented some great data at CTAD on the Simoa 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. I mean, so far, so good. The -- it was the -- is Lilly going -- Lilly has its own Alzheimer's assay, right? Is that going to be based on Simoa or some other analyzer assay vendor?

Yes. So, I think there was some clarity, at the CTAD meeting, there was a strong analytical and early clinical validation up to Simoa platform in 217. And as I view this, 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 I expect our efforts in cooperation to continue.

Okay, that was perfect. Thanks for that. And it was good to see the NIAAA guidelines 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 or like these tests that we're talking about here? And then how could those guidelines if finalized impact CMS decisions regarding reimbursement as well? Like, is that a question, given the size of tests, it's still pretty early days?

Yes, we agree with that, Kyle. I think it was nice to see the NIAAA guidelines and criterion. And 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 I really totally agree with what came up in the guidelines. One, in terms of a blood test to -- if it's going to be a blood test that's on the same playing field as PET, 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 -- to applaud the organization for really picking a great test, and great marker for diagnosis.

Perfect. One more before I hop off. The -- on just on the P&L, and I guess as you kind of break out revenue, you guys have a lot of one-time items if you parse out those out, you know, 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 that's not just due to the recent CapEx constraints. Maybe, the -- 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 in particular the instruments recently? And then for how much longer would you rely on kind of the service and accelerated revenue to drive growth?

Yes. 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 some of the instrument softness at least more recently, it's been, CapEx constraint, 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. I think if you think back, I'll say four or five quarters, when we announced the program and we built that quality wall, we added -- make sure things are going up the door. We're going to be -- things are going to be scalable at the highest level of quality. And so throughout the year, there's always going to be -- there's always going to be a year of focus on our products and getting them, the highest level to customers. So, some back and forth. But overall, the consumables are going out the doors of our customers, the utility and usage on a per platform basis is good. And as you could 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 the Simoa platform, and nor do we see it in the area that we're in.

Yes, I'd just add, within product revenue, if you're combining instruments and consumables, consumables are actually up 63% year-over-year and up 7% sequentially. So, 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 overhand one instruments continues, we do expect to continue to see volume comes through the Accelerator, which is helping to soften and balance that out for us.

Okay. And Vandana what was the catch up for consumables? That was like super helpful. Catch up is if you can quantify that, we're getting any questions about that too? Thanks.

Yes, I'm not sure we can quantify it in dollar terms, but if you just look at our sequential improvement, we've had about $15.2 million last quarter. We went up about $1 million this quarter. All of these have a little bit of just catching up on pent up demand. 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, Kyle.

Thank you. 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 of my questions upfront. First, could you give us an update into the timing of FDA filing and approval for loosen 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 in as fast as we can. And so that mechanism has been through our, CALIA, 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 within next several quarters to make sure we have a submission on our 217 to the FDA. And then in terms of timing, that can take some time. Of course, depends on the agency. But in the meantime, we think, getting testing done through the CAP CALIA lab is going to be important.

Yes. And on gross 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 by the 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 still -- 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 will 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.

Thank you guys and congrats on the continued progress.

Thanks, Jake.

Thank you. Our next question is from Dan Brennan with Cowen. Your line is now open.

Hey, good morning. Thank you for taking the questions. Maybe the first one just on the guidance. Just you've had some really good success here year-to-date. Just wondering on the fourth quarter kind of implied guide, it looks like kind of 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 how should we be thinking about that fourth quarter guide? And then, if we cycle past the fourth quarter, are we still thinking double-digit growth expectation for 2024 or just any early read there?

Yes, thanks for the question, Dan. So, for the fourth quarter, as Masoud 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 both 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 guide 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 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 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 kind of on the various kind of tests that you're looking to implement?

Yes, 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 test would need an accuracy that's above 90%. And when we did this, we did 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 multicenter, site 17 US clinical sites. And in both, large studies, we were able to achieve accuracies that were above 90%, which is the guideline or the criterion in the draft NIAAA. So, 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 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 a NCD in the future. Hard to say from timing perspective, but we hope that it gets the attention it deserves.

Great, thank you, Masoud.

Thanks, Dan.

Thank you. Our next question comes from Puneet Souda with Leerink Partners. Your line is open.

Hey, Masoud. Yeah, thanks for taking the question. So, the first one may be, and I don't know if this is 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 the performance that would be needed to deliver on P-Tau-217, where obviously Samoa has done well historically. So maybe can you just talk about how Samoa's position products that are [Technical Difficulty]

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

Yeah, 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 a blood test that's going to be on the same playing field or could be the diagnostic test, meaning something that's a rule in or rule out, you're obviously doing it some comparator, either CSF or PET. The two cutoff approach is incredibly important. So we use the two cutoff approach. It was recommended by the draft NIA 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. So I think that's it. 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. And then in terms of the sensitivity required, the guidelines, 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 remind folks that it's measuring the time of the assay, Ptau-217 effectively in blood, getting the femtogram per milliliter sensitivity, and then doing it in clinical samples, where you're looking at patients that are in the hospital 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 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 I think, based on these guidelines and some of the things that, 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? 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 217 is very important for diagnosis, and that has been well established, based on what I said earlier. But also want to make clear that this is an evolving field where prognosis, staging, differential diagnosis are all going to be important. It's not one patient comes in, they're diagnosed and that's it. There's treatment monitoring, there's following on the patient. And what we're seeing, if you look at the latest clinical trials and the research, it's going to likely be several multi-marker tests. 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 beta or a GFAP or NFL on the same run, same patient sample, is going to be incredibly important. And so, I think you're right, 217 is the best. 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,

Thanks, Puneet. Operator: Thank you. Our next question comes from Kyle Mikson 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 fee, the full year revenue for next year, that which is in line with this year's levels. Obviously, if the macro improves in the, like, you know, this fourth quarter run, it could be kind of conservative, but, you know, it sounds like the rollout of these new SKUs of assays could create some noise and possibly growing pains next year as well. So it's kind of, there's a 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 cache usage in 2024 as well would be helpful too. Thanks.

I'll give a broad stroke there, Kyle, on sort of the operational efforts and then on that I can comment on some of the margin and cache. So, you know, 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 accretive. 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 are out. you know, 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, you know, I think just similar to what Vandana said, you know, we're going to talk about that in February and we'll have a better sense, but you know, we still have a strong view that our, you know, research business, you know, continues to be strong and that we're seeing that, you know, continued Samoa demand. Thank you. for sensitivity and for our platforms and solutions.

Yeah, I'd say, you know, very consistent with everything Masoud 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 Masoud 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 break-even. We've previously guided to that 170 to 190 for cash flow break-even, and we'll continue to work towards that. At the same time, we will deploy some capital into diagnostics. 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, Quanterix clearly has the most sensitive tests. p-tau217 kind of, 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 a 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 product rather than the one you've already announced in Lucent AD?

Yes, great question Kyle. The sensitivity I would expect, you know expect 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 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 differential diagnosis. Let's also consider that there are folks coming in to the neurologist 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, 2017 is great, and it's, 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 what we're seeing in the field and what's coming out from 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 the whole picture.

Got it. Okay. That's perfect. Thanks, Masoud. Thanks, guys.

Thanks, Kyle.

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.