Good day, and thank you for standing by. Welcome to the Quanterix Corporation Q2 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. [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 VP of Investor Relations. Ed, the floor is yours.

Thank you, Stacy, and good morning. With me on today's call is Masoud Toloue President and CEO of Quanterix and Mike Doyle, Chief Financial Officer. 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 Masud.

Thank you, Ed. Good morning. Before getting to results, I would like to start by acknowledging the intense effort and progress the talented Quanterix team has made with our corporate transformation started last year. The magnitude of the improvements made while continuing strong operational execution is testament to the capabilities of our people, and these improvements have set a solid foundation to drive long-term future growth. This quarter those strides became more apparent in our business and financial performance. Second quarter revenue increased 32% to $31 million and our non-GAAP gross margin increased to 56.4% versus prior year with significant sequential improvement. We're seeing strong customer demand, driven by consumables and Accelerator lab business, with increases of 65% and 94% respectively. Our corporate transformation is also already positively impacting bottom line performance. This quarter, we achieved a breakeven cash flow milestone. With our accelerating redevelopment progress we increased our full year 2023 revenue guidance to be in the range of $110 million to $116 million, and full year non-GAAP gross margin percentage in the high 40s. We also expect less cash burn and now estimate to be in the range of $30 million to $35 million this year. To remind you, we initiated our corporate transformation a year ago following a strategic business review with the prime objective of maximizing the potential of our Simoa technology and delivering high-quality assays at scale with strong margins. We're now in the last two quarters of our transformation process and remain on track. Work that remains includes launching new assay kit SKUs and further implementation of newly scaled systems and modern processes in our operations lines. The intensity at which our team at Quanterix, have made progress is remarkable. These efforts will directly impact our long-term growth and drive future positive cash flow.…

Thanks Masoud. For your reference for those following along, I'm starting on Slide 8. Our total revenue for the second quarter of 2023 was $31 million, an increase of 32% from the second quarter of 2022. This quarter's revenue includes $1 million for onetime revenue related to our agreement with Ultra DX Limited in China and $0.5 million related to an Abbott license deal. We had product revenue of $19.7 million in the second quarter, an increase of 33% over the second quarter of 2022. Within product revenue, instrument revenue was $3.5 million, a decline of 38% over the second quarter of 2022. As described last quarter and similar to other life science instrument providers, we continue to see global macroeconomic pressures on capital purchases. Offsetting this decline our consumable revenue increased $6 million, or 65% compared to the second quarter of last year and up 8% versus the prior quarter. While we continue to manage production and demand for consumables as we address asset quality, we have made improvements that have allowed us to increase capacity. Services and other revenue was $10.6 million for the quarter, increasing $2 million or 23% from the second quarter of 2022, driven by strong demand for Accelerator Services. Our Accelerator Services continue to be valuable -- a valuable customer offering, particularly when biotech and pharma experienced pressure on CapEx purchases. While we don't expect further decline in instruments for the second half of the year, we do expect both consumables and Accelerator Services to fully offset for the second half, until biotech and pharma returned to normal purchasing patterns. Now, let's move on to gross margin for the quarter. Our GAAP gross profit margin was $19.1 million and 61.7% for the second quarter of 2023, compared to $8.7 million and 37.1% in the…

Thank you, Mike. I want to provide an update in regard to our financial leadership transition plans. As previously announced, Mike is planning to retire in early '24 and we've been searching for a new CFO and it's an exciting time clearly to join Quanterix. And I'm thrilled to say that we found someone amazing to join our team. So, we'll be making a formal announcement tomorrow morning and the official transition is set for August 21. At that time, Mike is going to transition to Executive Director of Finance, supporting our strategic growth until his retirement March. So I want to take a moment to acknowledge the pivotal role Mike has played in the transformation of Quanterix, specifically his guidance, dedication and financial leadership over the past two years has put us in a strong position. He has made a lasting impact on our business. We're appreciative of his service, thankful for the solid transition period, and look forward to what's had in the coming months. Operator, let's take some questions.

Thank you. We will now conduct the question-and-answer session. [Operator Instructions] Our first question comes from Puneet Souda of Leerink Partners. Puneet, please go ahead with your question.

Hey, thanks. Masoud, Mike, thanks again and congrats on the quarter here. Mike and -- really great working with you and good luck on what's ahead. And maybe if I could, first one maybe if I could ask on the guide and then I have a follow-up on LucentAD on the biomarker set. We look at the full year guide, if you go to the higher end of the guide it still implies a step down in 3Q and 4Q. I know you talked a little bit about obviously the biotech funding situation that is well understood and known on the street. Is that largely part of the conservatism in your assumptions here, or is there something else that we ought to keep in mind for the second half? I just want to clarify on the top line and also on the gross margins?

Sure. I think a couple of things. I think, we obviously had some onetime revenue in this quarter. And so when I look at the 31, I really look at it at about a $29.5 million quarter. So, I think we're still balancing our redevelopment effort and this last couple of quarters which Masoud is going to get into is when we really -- it's the last big push. So we expect a little bit of noise and we're trying to just sort of make sure that we've given ourselves some room there. Clearly, our goal is to exceed that. But that's how we're looking at it. I don't think there's anything else out there than what we've chatted about that we would see impacting our revenues.

Yeah, I think that's right. Puneet we – clearly, there's a backdrop of this macroeconomic situation. I think Mike highlighted on the call that we've been able to offset that pretty effectively. And we'll see what happens in the second half. And then as Mike said, a lot of implementation of key processes in the production lines that we want to be conservative about.

Got it. Okay. And then wondering on Lucent, can you clarify if this -- when this platform is going to have p-Tau 217 as well beyond 181, and when do you think we'll see a marker said that, that involves p-Tau 181 to p-Tau 217 Aβ40, Aβ42 both as an LDT, and then eventually as an IVD and potentially maybe one more marker let's say GFAP in it. So just trying to understand what the final market said, could look like when do you think you'll be able to launch that as an LDT and then eventually into IVD?

It’s a great question, Puneet. So we -- our plan is to have 217 LDT this year. So some other future announcement we'll talk about including that into our Lucent series of testing. And then on your question about the multimarket test, just as you know the multimarket test today already exists at Quanterix as an RUO offering. And then to your point, we intend to add that to the LucentAD offering, after we complete some of our clinical trial work. So we have -- we talked about the results of Bio-Hermes specific to 181. We're expanding that and looking at multi-marker, with that study. And then we have a very exhaustive large study with ADDF where we're looking at all the markets that you just mentioned, with an algorithm to look at amyloid pathology for patients. So that's also upcoming. And again on the regulatory side our intention is that we'll be submitting these to the FDA, along with the clinical trial findings.

Got it. Super. And then last one for me. Can you talk a little bit about the level of validation that you have currently with your assays? And what is needed for the diagnostic assay for the LDT and potentially for the IVD as well. And sort of what sort of level of readiness that you have as Leqembi and Donanemab these drugs get on the market? How do you think scalability, if rapid scalability is required? Just want to get a sense of if you -- validation and other things that might be needed for those assays, how positioned are those assays from both a validation point of view and a scalability point of view? Thank you.

Thanks, Puneet. Yes. So, when we -- I would say the foundation -- first let's talk with the foundation of the assays. We're talking about hundreds and hundreds of publications over peer-reviewed publications over the last several years, that have shown the biomarkers that we're talking about 181, 217, NfL GFAP together incredible correlation to amyloid pathology. This is really robustly shown. And that's kind of a -- that's our RUO basis. We take that one step further, and we're working on these prospective clinical trials. So the Bio-Hermes for example, trial that is used to support our P-tau181 LDT was an 18 site US trial over 20 of the samples were from underserved populations. Critical for Alzheimer's testing, as you'll probably hear about more and more in the news. And we looked at imaging clinical and other key data, to support our LDT. And we look at patients that are cognitively unimpaired MCI and mild AD patients and we compare each of our tests to imaging and to CSS. And that's the data and the backing we have for 181, and we expect to continue to do that for each of our tests that come out as an LDT. And we think the data and robustness is also sufficient to support future regulatory filings. So from a clinical trial a utility perspective, we have great work that's ongoing by the team. And then from a scale perspective, we believe that scaling these assays are going to be critical. Blood-based testing is going to be critical for entry to therapy. And how do you scale the test as in a robust way as possible. We think number one, you heard about the guidelines. All of the markers in the guideline today can be run in Simoa and we'd support a new lab globally who would purchase a Simoa platform to get their lab up and running for them to do testing. The second we can do thousands of samples here in our CLIA laboratory on a weekly basis. And we think that will take some level of support for building this global infrastructure. So I think we have a plan. We have a good clinical trial plan and a good go-to-market plan on this NAD. So we're really excited about the next several months.

Okay. Super, good. Thanks.

Our next question comes from Kyle Mikson of Canaccord Genuity. Kyle, go ahead with your question.

Hey, guys. Thanks for taking the questions. Congrats on the quarter. And congrats on the progress on this redevelopment program. On the program Masoud, I just wanted to ask how you've been able to convey to customers that reproducibility, the scalability of your assays has now improved. And how that approach and how the customer response kind of differs between those RUO and the biopharma customers?

Yes. Hey, Kyle, thanks for the kind words. We – I would say that if you look at our – whether it's our consumables, Kyle or our Accelerator, I mean we're hitting levels of demand that the company has never seen before. So – and I would say that what we're able to manage and ensure is that, if it's a product that's leaving the doors at Quanterix, it's a quality product in the customers' hands. So I'd say, we've done a great job at doing that. And then over the next several quarters, we're going to ensure that those SKUs that are leaving the door also scalable and accretive to our margins. So couple of quarters of work left, but right now today, we're getting good assays to customers and we're providing solid work through our Accelerator program. And I think the results speak for themselves.

Okay. That was great. And then just following up on the BioHermes. So are we completely done with readouts for that trial? And then did you comment on the timing for the diabetes approval?

Yes. So we are complete with our 181 study. And so that the BioHermes trial data supported both our LDT and the FDA filing, we have that exists for our pTau-181 test. Now what we're going to do next is we're taking a look at other biomarkers with that data set. And there'll probably be more news in the future on BioHermes. But with regard to 181, our intention is for peer-reviewed publication on those testing results but you can already see the data for that and our sense and specs on the Lucent AD website. And then on the second trial that we've been talking about is this multi-marker test with ADDF, that’s the global test, global trial and that's going to be to support the multi-marker. We haven't mentioned any sort of timing on regulatory filings. As you know we have a breakthrough designation for 181 and we've talked about doing more work with the FDA as we progress

Okay. Awesome. And then maybe Mike if you want to comment on this and I guess congrats on the next steps and look forward to kind of chatting about it soon. On the prioritization of cash, you have cash of $330 million net cash flow in the quarter was breakeven which is great. I mean, it's fantastic. I think in the past you estimated that you will achieve positive cash flows at the $170 million to $190 million range for revenue. That's like 226 maybe. I guess, I want to ask is that pushed up now? Is that -- or I guess pulled forward could you kind of reach that point earlier -- and just given all what's cushion now, I mean, how do you kind of anticipate using cash going forward? Could you kind of crank up the spending to drive revenue growth or really scale LucentAD or something along those lines?

Yes. Thanks, Colin. I think, first, we haven't adjusted our projection longer-term for will be, I would say, cash flow positive consistently, I'd say, we still keep our current guidance in place probably updating in February. Look and we were -- look super happy with the quarter. And I think what it's demonstrated is, we are running ahead from a financial standpoint, and I think that we've been very focused on the assay redevelopment. I think what you're going to start to see and you've touched on some of it Kyle is investments in -- organic investments in the business, also funding more for Lucent DX. So I expect we're going to see cash go out. CapEx was light in the first half of the year as we stayed focused on the assay redevelopment, it's going to pick up in the second half of the year. And I think we're looking at because we have the cash we do a number of things both organically and down the road inorganically that will help us accelerate our ability to grow. So -- and like I said, we'll probably be updating guidance in February on the call and we'll probably update our targets for cash flow breakeven as well.

Perfect. Sounds good. Thanks guys. Appreciate it.

Thanks, Kyle.

Thanks, Kyle.

[Operator Instructions] Our next question comes from Matt Sykes with Goldman Sachs. Matt, please go ahead with your question.

Thanks for taking my question and congrats on the quarter. And Mike congrats on the next chapter. It's been great working with you. Maybe just a first question for you Mike. You've previously talked about double-digit top line growth for 2024 just given the guidance raised last quarter and this quarter, are you still kind of thinking about that as a range for next year? And any kind of clarity on double digits, it could mean a lot of different things.

Yes, it can. You're right Matt. It's -- because we're obviously -- we've had a good quarter and the point of the guidance would suggest is our core product that we're there. And I think our goal is to accelerate from there. We haven't fleshed out yet a 2024 forecast to get more specific about what double-digit looks like and feels like. But clearly our intent is to accelerate off of where we are today. So that's probably all we're going to say on it right now, but I expect again in February we'll be giving a more robust view of the year and what double digit is going to look like. But clearly, we're in a good place right now and are feeling pretty good about where we sit this year, and we're obviously on the core products cracking double-digit right now.

Got it. Thanks for that. And then just you mentioned in the prepared comments about the Abbott collaboration and some of the revenue you received from that. Can you just maybe provide a little bit more color? I apologies if I've missed this in the past But just a little more color on what you're doing with Abbott.

Yes. Actually the Abbott is an expiration of an old license deal. So it's not an active. Essentially we received funds some time ago for a license that's now expired so we're recognizing it in revenue. So it's not new activity per se with Abbott. And then the $1 million from Ultra-DX is a reflection of shares that we were issued in the Ultra-DX venture in China. So, in both instances those are onetime revenue and they're not going to repeat. So, they impact margin in a favorable way this quarter by about 250 basis points Matt just to give you some perspective there.

Got it. And then just one last one for you Masoud. You talked about the study that looked at finger prick testing in the blood cards. And could you maybe just talk longer term about what you think that could do in terms of accessibility but also kind of what the time line potentially for that could be and how it be incorporated into your logistics and technology if that were to happen?

Yes, absolutely Matt. So, just say that we're sort of on the heels of all this excitement on blood draw and traditional collection methods. But keep bringing up this concept of global scale and global infrastructure. And while in the US let's say 90% of the population is near a place where you can do a blood draw you got to think globally. And there are a lot of places where low temperature storage transportation centrifugation those are all issues. And what we're really excited about by this study was that demonstrated the ability to do remote collection and quantification of all the biomarkers that we have. And so we can see this as a screening and monitoring tool in secondary care in therapeutic trials. So, expanding access to therapeutic trials to underserved population which is going to be important for future therapies as well as the storage concept and being able to monitor progression of treatment response in an easy way. So, you don't have someone coming in on a regular basis for a blood draw and you can do the smart home. So, it's early days in the study and the cohort and the population was a small population. So, I do want to say that. But incredibly promising data on the correlations with pet and CSF. And so we're very excited about what this study could be and I think that there's a lot of interesting work that could come in the next within the next year or so for detecting these biomarkers. And then the final point I'll make is that this sort of goes to show -- I mean we're talking a blood draw hundreds and hundreds of microliters. Now, we're talking about tens of microliters and the need for a platform that has high sensitivity to detect that in those tens and tens of microliters is what's required to enable blood card testing. And so, again, we're very excited about the prospect of these results.

Got it. Thanks very much guys.

Thanks Matt.

And our final question comes from Dan Brennan with Cowen.

Thanks for the question.

Dan?

Sorry. Congrats on the quarter. Maybe one on placements in one back on Alzheimer's, Just can you speak to instrument placements in the quarter? Sorry, if I missed it. And what are the expectations throughout the year how much of softness was due to APAC. I think you called out a distributor in 1Q. Just maybe some color there.

Yeah. Dan. I mean, placements in the quarter were -- net placements were 22% which is -- that's a low for us. Historically, we've run high-30s to 40s and it started to drift late last year Q1 placements were 32%. So we're down. I think Asia Pac was our issue in Q1. I think more broadly and I think Masoud mentioned I did as well, we're seeing it really across the board. I think there's just a macro effect on CapEx that's impacting us. And we're seeing it, in North America, Europe and in Asia Pac. Asia Pac actually in the quarter performed better than they did a year ago. So it bounces around. Now, the good news for us is, we get still are getting revenue from people who would otherwise purchase. I think Masoud referenced, I think folks are running more through our Accelerator lab, as opposed to purchasing an instrument. So I think as the broader macro improves, we're going to see instruments pick up which is encouraging. But right now it's -- we're kind of at a -- it's going to be soft. I don't expect it's going to degrade from where we are. That's how we're projecting and building out the balance of our year and we expect in 2024, a return to something more normal.

Yeah. Dan, one of the really unique capabilities that we have is that, when we've seen biotech or pharma capital equipment pressure or kind of macroeconomic challenge, we tend to see these companies outsource more and more of their work to our Accelerator lab. And we're clearly seeing more of that and expect this to continue for the second half of the year. So Accelerator for us is both tried before you buy, but it's also outsourcing a lot of R&D work. And in the future we expect those customers will -- once there's less pressure to come back and purchase those platforms.

Great. Thank you for that. And then maybe just kind of a bigger picture one on Alzheimer's and apologize, maybe this was mentioned a little bit throughout, but just maybe you could get a list. What are the -- if we look out over the next 12 months like what would you say the key markdowns to watch that would be kind of most important just to kind of check progress and see the opportunity is materializing for Quanterix?

Yeah. So Dan, I think the -- we talked about the readout on this by Hermes test and how it's supporting our LDT and also our IBD filing. I think -- it was a question earlier on the call related to 217 that Puneet asked. I think that's pretty important, 217 is a biomarker that you just can't measure on any platform, right? And so Simoa is one of the platforms that you can detect 217. And so the interest and demand for 217 is important. And one of the reasons you're kind of hearing about that importance is because as these drugs and these therapies come out, we're seeing data that shows the earlier you can identify a patient in the disease cascade, the better the therapy works. And so 217 is one of those early markers. And so from a standpoint of a screen or a diagnosis, the better -- you can get a better patient cohort and it looks better from a rule-in perspective. So we're very excited about that. I think that will be a big milestone. And then the second is on the multimarket. Can we do differential diagnosis? Can we use a near a multi-marker to get more information on these patients that might get a negative result. And they're asking "Hey I have cognitive symptoms, but I'm getting a negative result. Now what? " And so behind what we're talking about here is an intensive program to build solutions for patients. And so I think I would view those two as the next two key milestones. And then externally, I think if you look at the guidelines, some of the biomarker the promise and blood biomarkers is incredible. And so we expect in the next several months there to be more discussion about blood biomarkers and their adoption from not just the screen, but more and more towards diagnosis of patients instead of a spinal tap or a PET scan. So I kind of would view those sort of three areas as key milestones for us and for the field.

Great. Thanks a lot.

Thanks, Dan.

I am showing no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.