Hello, and welcome to the Quanterix Corporation First Quarter 2021 Earnings Conference. My name is Michelle and I will be the operator for today's call. At this time, all participants are in a listen-only mode [Operator Instructions]. I will now turn the call over to Amol Chaubal, Quanterix' CFO. Sir, you may begin.

Thank you, Michelle. Good afternoon, everyone and thanks for joining us today. With me on today's call is Kevin Hrusovsky, our Chairman and CEO; and Shawn Stetson, our Corporate Controller. Before we begin, I would like to remind you about few things. Today's call will be recorded and will be available on the Investor Resources section of our website. Today's call will contain forward-looking statements that 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 statements. The risks and the uncertainties that we face are described in our most recent filings with the Securities and Exchange Commission. During today's conference call, we'll discuss some financial measures that are not presented in accordance with US Generally Accepted Accounting Principles, or non-GAAP financial measures. In the Q1 earnings release and in the appendix of our presentation, which are available on our website, you will find additional disclosures regarding the non-GAAP measures, including reconciliation of these measures to comparative GAAP measures. We believe that these non-GAAP financial measures provide investors with relevant period to period comparisons of our operations. These financial measures are not recognized under GAAP and should not be considered in isolation or as a substitute for a measure of financial performance prepared in accordance with GAAP. With that, I will turn the call over to Kevin.

Thank you very much, Amol. And we're very excited about our Q1 performance. And I’ll start off with an agenda on Slide 3, basically going to talk about our accelerated growth, numerous what we would call growth catalysts for the remainder of this year and for next year as well as the scaling potential that we feel we have as well as the strategy that we're evolving. We'll then talk through financial results to growth, particularly the growth margin and the growth capital. And finally, we'll spend some time talking through our 2021 objectives. So on Slide 4, you can see we had 58% non-GAAP growth year-on-year, which we felt was an incredibly productive quarter. Certainly, some catch-up here from the COVID crisis. I would say that most of this growth, 80% of it, was due to just primary recovery of the markets that we're serving. Maybe 20% of it could be viewed as catch-up, but still very robust order for us, and on a GAAP basis, that was 73% growth. That GAAP includes some of the RADx NIH funding that was declared as revenue in Q1. You can also see that we had a very strong Instrument quarter, 86% Instrument on a non-GAAP basis - on a revenue basis and 86% for Consumables. And those 2 are our primary product dimension of our business. The lab services had modest growth and we expected that this year would be somewhat flat versus last year where we had nearly 100% growth, because there was a surge for COVID demand for our services as well as many of the HDx' being validated. So we did expect this year to be rather flat on Services compared to previous year for that reason. You'll also see that we had 1000 BPS point improvement, primarily…

Thanks, Kevin. I mean, as you said, it's been an incredible learning experience for me under your leadership and very proud of what we've achieved here at Quanterix. And will always be part of our broader PPH ecosystem, where more and more companies, investors, KOLs continue to participate in our mission of early disease detection when these diseases can be cured and its game changing for patients. I'll be providing some additional financial details about our Q1 2021 performance. And I'll be referring to Slide 29. As Kevin noted, GAAP revenue in Q1 2021 was $27.2 million and included $2.3 million of revenue from our RADx awards. Excluding this nonrecurring item, our non-GAAP Q1 2021 revenue was $24.9 million, a 58% increase versus prior year Q1. We had record Instrument revenue in Q1 2021 with $7 million in revenue, an increase of 86% versus prior year Q1. Consumables revenue grew 86% in Q1 versus prior year to $11.3 million, driven by significant demand for pTau-181, neuro multiplex assays and COVID RUO assays. Our strong revenue performance in Q1 may include some recovery of previously deferred demand due to pandemic as customers returned to more normal operations. Service revenue increased 11% in Q1 to $6.4 million and was somewhat limited due to resources and supply diverted to support our strong consumables demand. As stated previously, we are not providing revenue guidance. Customer activity has returned to pre-COVID levels. However, a potential renewed spread of new coronavirus strain could force renewed lock downs, potentially impacting installations and utilization. On a GAAP basis, our Q1 gross margin was 60.1% and was favorably impacted by our RADx grant revenue versus prior year Q1 gross margin of 43.3%. Our non-GAAP gross margin was 58.5% in Q1, which was an approximate 1,000 basis points improvement compared…

Thank you very much, Amol. And I'm just going to close with our objective slide, where we do show RUO growth from 2019 to 2024, 2019 being a better base year of 30% to 40% compounded annual growth rate. Neurology increasing our trial penetration to greater than 10%. 65% of our HDx installed base at year end 2021, which means the HD ones will be a much lesser component of our future, which HDx’ have greater pull-through and greater consumable growth opportunity. Also, we mentioned the NfL diagnostic LDT plus AD pharma drug trials. We want to continue to evolve those. COVID, we want to drive a leverageable Antigen & Serology EUA penetration, deliver our RADx scale up that they gave us 20 million to scale up our technologies. A key of the COVID drug trial adoption that already has started and expand the surveillance from payers of the COVID landscape. Immunology, we want to continue to expand many of the interferon and interleukin cytokine assays, which we think also relates to COVID and expand our SP-X placements, and also continue with our payer pharma long-hauler trials. And then financials, in addition to the growth that we've already mentioned, we want to have 240 HDx’, SRx’ and SPx’ placed this year. That's a large number. And then we want 60% of those installs to be HDx which is our most profitable and the highest pull-through instrument that we sell. And on a platform level, scale the Quanterix supply and global channel, define the pathway to deploy this 100x sensitivity, hopefully through partnerships with some of the leading pharmas in the Alzheimer field, where we can go for precognitive impairment expansion and then keep building those strategic partnerships. With that, we'd like to turn it over for questions, and I'd like to open the lines up.

Thank you, sir [Operator Instructions]. The first question I have in the queue comes from Tycho Peterson.

This is Casey on for Tycho. I guess the first one is around COVID contribution for 1Q. Can you just quantify what the antigen and antibody tests contributed to the quarter? And then also on the research side for COVID between research being done on long COVID and then the drug trials as well, just any sort of way you could quantify the COVID contribution here this quarter and moving forward.

I'll start and Amol you can provide additional clarity or Shawn. Basically, we don't provide a lot of granularity, but I would say that the COVID revenue for Q1 from our vantage point is clearly less than 10% of our revenue. We are primarily seeing it in research early on supporting LDT research as well as some of the drug trials that we mentioned. And so it's not a significant component to our Q1, and we didn't have much in 2020 either. So there weren't a lot of tailwinds. It was mostly headwinds in 2020. Now the only other exception to this is if you go from non-GAAP to GAAP, you will find that we had little over $2 million of NIH funding that would have been COVID related. So on the non-GAAP it's less than 10%, but on the GAAP, there are some funds. Any additional color here, either Amol or Shawn?

I mean, as Kevin noted, right, I mean on sort of the EUA COVID approval, the revenue has been minimal. I think most of the revenue is really on the RUO assay, as we see this new dimensionality get added to our technology. And what we remain absolutely excited about is the level of adoption we've seen in some of the leading-edge research happening in some really key research houses like NIH, where they continue to work with our technology on long-haulers and that could provide some long-term applications for this technology. But again, for the quarter, most of it was sort of research assays getting used in sort of LDT or research settings.

And then can you sort of talk to any progress that's been made by Siemens and Abbott from each of respective partnerships? And then what are sort of the next steps there and time lines for sort of milestone payments there? Any color on each of those.

First, I would say, Casey, good question. And I think we remain very bullish on both of these relationships. We've seen a lot of activity from Siemens continuing to evolve the NfL. And we do believe that over the course of the next 12 months, we'll continue seeing them involving this for their installed base. And that's the primary purpose here is to give our NfL legs and to try to keep the standard. We've got the best, highest specificity antibody pairs when we acquired Uman, and we would like to continue to evolve that with many of the diagnostic houses. And in the case of Abbott, that was actually a Simoa license. And so they are working to incorporate it into their technologies and that is not a short-term advance. That's going to take time because that's engineering advances. You can't simply take existing installed base to Abbott technology and convert it to Simoa. It requires actual componentry that's associated with the IP that they licensed from us. So that would not be anything you should expect to see any significant advances from Abbott in 2021 as you will from Siemens.

And now if I can just sneak in two more quick ones. In terms of pipeline for liquid biopsy partnerships, you talked about this in the past. Can you elaborate on any progress on signing deals with companies like Thrive and the like? And then we've gotten this question more and more on how should we think about the Lilly Alzheimer drug data that was disclosed in March? What does that mean for Quanterix, maybe from a high-level perspective and also as it relates to your collaboration with Lilly on the Alzheimer biomarkers.

I think first, on the liquid biopsy, there's two companies that already have our technology that are productively advancing. One's Freenome and the other is Volition. And these two companies are utilizing the ability to see proteins much more sensitively and having much lower LL, lower limit of quantitation. And so this is key for many of the algorithms that the liquid biopsy companies have been evolving is, not just looking at genomics, but also proteomics. And we have showed in previous presentations, some of the critical proteins in the Thrive algorithms that we do believe we can bring some value to those algorithms for seeing certain proteins that today's technologies wouldn't, most of the standard that they have been using was based on Luminex, they would not -- the lower limit of quantitation or detection was not low enough to be able to detect these proteins. And we do think that those algorithms could be enriched. And so, there's no advances that we would speak of publicly at this point, except that we are showcasing that data and we still have a good -- strong belief that there's a lot of utility for using our technologies in the liquid biopsy landscape, but we ourselves feel like the drug companies aren't as excited and as interested to use companion diagnostics in oncology as they are in neurology. In neurology, they really can't get a drug approved in many cases like Alzheimer's without the support. And that makes it a much more attractive win-win environment for us to work with the drug companies in neurology and the area of liquid biopsy. Unfortunately, many times, it restricts markets and reduces the size of the markets when you utilize companion diagnostics. And that is where we just want to partner and allow those…

[Operator Instructions] The next one is from Chris Lin.

Kevin, Amol, thanks for taking my questions and congrats again, Amol. Kevin, maybe just to start, could you update us on your oncology market efforts? Growth there has just lagged the neurology business, but Simoa is uniquely positioned in that market just given the sensitivity. Also, I think one of your slides talk about the launch of a 10plex assay. I am curious if you think that should be able to catalyze oncology growth given the utility of multiplexing within that market.

I think that one of the things that the COVID pivot did, in fact, achieve for us is that many of the oncology labs did shut down in 2020 and became COVID labs. Because if you think about a lot of the early impairment -- acute impairment of COVID patients was cytokine storm or pneumonia from cytokine storm, where the immune system basically unraveled very rapidly and they needed to then try to control the immune system, or they found themselves in cytokine storm. And what we basically do for oncology is immunology. We're looking at the immune system and in the places where there are immunotherapies getting more research into how the drugs interrelate with the various cytokines, whether they be interleukins or interferons is the key to our 10plex. And so, yes, we did launch the 10plex, which basically has been utilized more for COVID because many of those labs had, like I said, converted to COVID labs. So I would say convert back. We believe in the second half of 2021 and 2022, it should bode well for our oncology franchise, which does take a second seat to what we've done in COVID and certainly neurology. And so, as the neurology has further heated up with the Alzheimer excitement over the last 6 months, coupled then with COVID basically reigning on many of the labs that were oncology labs, we don't expect a lot of short-term focus on oncology. We think it would be focused what we think is an incredible opportunity in neurology and COVID. But as those labs transitioned back into oncology labs, we think we'll be well-positioned. And so, that's the way we're staging this so that we're getting the optimal use of our OpEx and keep the growth targeted where we have the greatest opportunity. And so, because neuro and COVID both sit right now in very strong positions, we are trying to make sure we capitalize on those opportunities before diluting our efforts into oncology.

And then Kevin, the pipeline of early life science tools companies has been rapidly increasing over the past few years. You have a very strong balance sheet, especially with financing earlier this year. You also made a number of strategic acquisitions or a few strategic acquisitions over the past several years. So now with that in mind, I was hoping if you could give us an update on your capital development -- deployment efforts, and if you see any opportunities for M&A in the near future.

First of all, I think we had a lot of investors that were interested to get into our stock and we found it a nice win-win to put more cash on our balance sheet to just give us better protection in the event of a downturn as well as to allow us to look at strategic M&A assets, as they might advance our strategy key to the way we look at M&A is that we're looking primarily for ways to advance our strategy as opposed to any opportunistic pure play M&A. And when we look at it that way, we certainly see a lot of opportunity for evolving our laboratory accelerator services footprint as well as globalization around the world are two key areas that we think M&A could in fact enhance and advance our strategy. Another related area would be for assay development and for antibodies that we think are key. The Uman antibody pair was highly specific, and we were able to see it because of our sensitivity and our Simoa technology. And that gave us an advantage in knowing and seeing the potential that the Uman company and those antibody assets represented. And so, similarly, when you look in the pTau franchise, there are some newer phosphorylated Tau’s that are creating great stratification as well as early detection of precognitive impairment Alzheimer's patients. And so, anything we can be doing in the assay development and/or antibody landscape, whether it be licensing, key antibodies, or actually acquiring them, we think that that is another area that they know capital deployment could be a very productive advance for our investors because of it accelerating our strategy. So we do have a strong balance sheet and we also won because it also allowed us to invite in some newer investors that we think have been very productive, because if you also recall, many of our investors create demand for us by introducing us to the pharma companies that they own. And those pharma companies trying to get drugs approved benefit by using our technologies. And so, investors end up becoming a real good commercial opportunity for us to increase our pipeline for selling our technology. So we actually think that the raises were very productive and subsequently, it's given us a balance sheet to allow us to look for a way to accelerate our strategy. So we feel very productive opposite our current balance sheet dynamics and ability to deploy capital for strategic assets that come on the market.

And last question for me and probably for Amol. I think I heard that the catch-up dynamic contributed 20% to revenue growth this quarter. Did that primarily impact the Instrument business or do you see a benefit on the Consumables and Services side as well?

I think I'll start, Amol, and then you can maybe follow up. I think that, in general, there's some level of catch-up because you have some customers that basically depleted their stocks. And when they went into shutdown mode, they started many times to utilize our accelerator. And so, we estimate that there's some level, not as significant, probably 15% to 20% of the very strong growth we had in Q1 that could be allocated to some level of catch-up. But the instrument was certainly a stronger instrument than we've probably had in really four years. And this has been an area that we've been continuing to ramp up because we've got new form factors, which have been very productive and the HDx itself has really showed its capability, and that's allowed a lot of customers to want to get into the HDx. And so, I do think that in much of what you see in Instrument, demand is, in fact, strength and we believe continue to be an area of strength, but we ultimately believe our consumables will grow the fastest because it's an installed dynamic where you have an installed base. Then you have utilization that we keep increasing by expanding our menu. So utilization levels give us a double pronged opportunity for growth in the area of consumables. And so that's where we would expect our growth on when we say 30% to 40% CAGR, it's going to be highest for consumables, and it's likely going to be lowest for Instruments, but it's going to be in the averages for Services. This year is an exception for Services because we did grow 100% last year. So Amol, any color to add there?

I think you've covered it well. I mean, Consumables, because of the shelf life, the impact is going to be small. Instruments, it's hard to parse out, because there are several positive factors providing the tailwind for instruments. Catch-up being one of them, but also the HDx performance is well received. There's also demand for neuro multiplexes and pTau’s that’s creating new demand for instruments and the whole COVID dimensionality and RUO is creating demand for Instruments, right? So it's hard for us to parse out. There is some catch-up in the Instruments which will come out in the future quarters. But other than that, as Kevin said, it's small.

The next question in the queue comes from Max Masucci.

So with the vaccine rollout, the utility, the role of antibody testing for COVID-19 purposes, I think it's becoming more defined. So can you just give us a sense for which types of antibody testing projects are seeing the most traction? Is it serial testing programs to sort of understand how vaccine immunity degrades or understanding the right dosing or effectiveness of therapeutics and vaccines, but it would just be great to get some color around what you've experienced firsthand in a serology market that's sort of evolving in real time?

I would say, Max, your question is very strong because everything you described, many pieces of what you described, we're seeing. And one of the things that our serology test is going to enable is the ability to quantitate how much antibody is there. And we're only one of two or three EUA’s that have quantitation. We also made a move, about, I guess, two months ago with Dawn Mattoon, who you might recall. She actually joined us from Cell Signaling, had a significant backdrop. I was on their Board and got to know her while being on the Board there. But that's one of the top antibody companies in the world. And she joined us about three years ago. And we've now assigned her to help us build out the diagnostic franchise. She's done an incredible job helping us get the EUAs, working with the FDA for both serology and for the antigen test. And we now see many different shots on goal for utility and serology, and we're going to be planning additional moves over the next couple of months, because we do believe that COVID is far from over. When you start thinking about the immune system protection against COVID, the things that you mentioned, the durability of the vaccine. Key question, will there be a need for boosters? We've listened to the Pfizer calls yesterday. There was a lot of belief that boosters will likely be needed. Also, how do you quantitate when a booster is needed? And how about the variants that are starting to emerge? Particularly when you see the surging occurring in India, where you've seen as many as 400,000 proven and tested demonstrated cases in one day, which means that it could be twice that when you consider what's maybe undetected. When…

Final question for me. I'd imagine the catch-up period for demand will be drawn out over the course of 2021, sort of given the global nature of your customer base. That should pad what you can consider, I guess, organic demand. I guess, first, is that a reasonable assumption? And then, second, can you just give us a sense for the split between Q1 demand that was driven by new customer wins versus utilization increases for existing users? Just trying to get a sense for the recovery on both fronts. And that's it for me. Thanks.

I would say that we are entering into a phase now where we do, unless there's a relapse of some significant proportion, we think that the reopening of many states in the United States, and as that starts to cascade into other sectors into Western Europe probably hopefully being next, and then ultimately some of the more serious current situations getting corrected in South America and India longer term, we do believe that we will continue to see a rebound in a lot of the research that many cases wasn't put on hold because they utilized our accelerator. So we had this great opportunity to further invest early in 2020 to build out our accelerator assets to cover and allow customers to continue a lot of the research and our services. And that's where we do think many of those service opportunities will emerge back into the actual customer labs, where consumable sales will go back across their instruments in their labs. So we do think that that's going to be a very productive area for future expansion. And we do think that throughout the year, as we look at customers that are utilizing the technology historically buying and re-upping their consumables across their instruments, obviously, is a key area of our current growth. But interestingly, those Instruments sales you saw peak in Q1, many of those are brand new customers. And so this is really good news, as the neuro opportunity, particularly in Alzheimer's and MS and Parkinson's, is hitting at the same time because those trials continued while the COVID crisis was shutting down many labs in our accelerator. So that's enabling new customers now that used our accelerator to buy instrumentation. So we get kind of a double prong of both existing customers utilizing and continuing to kind of get back into action, but then new customers that experienced us for the first time through the accelerator during this period, giving us a good opportunity as well for growth with new customers. I hope that helps, Max.

And I do have one more question in the queue that comes from Puneet Souda.

Kevin, first of all, congrats on the quarter. And Amol, we'll miss working with you on Quanterix, but congrats on the new role. So just 2 questions for me, Kevin. First one on neurology. I mean, as you are seeing increasing involvement in the neurology trials, how should we view the long-term diagnostic opportunities if and when those drugs are approved? How do you think you will be participating in that? Is that through licensing or could we see potential direct installs, direct revenue there? And then just broadly, in terms of your CRO relationships, can you give us an update there where you stand currently? What's the penetration where you're at and where you'd like it to be? And how does that impact your accelerator revenue longer term? So that's it for me.

The first, this diagnostic opportunity for Alzheimer's really is something that we are gearing up for, given our relationships with pharma, who have a lot of interests in evolving our technology of blood plasma markers, into health screens as well as management of residual disease, post and approvals. So we had most of our focus, Puneet, on MS, as you know, with NfL up until COVID hit. And NfL found its way into helping us measure loss of taste and smell in the COVID landscape, but it also played a role in Alzheimer's. And so, we've got multiple shots on goal of showing neuronal death, and then more specific markers like the phosphorylated Tau’s and even GFAP for some levels of inflammation for the Alzheimer cascade. And so, I think what you might see evolve would be a multiplex that would have a lot of diagnostic relevance, post and approval. And the multiplex would look at neuronal death from the NfL, but would look at some of these pTau’s for more specific stratification in understanding the disease and trying to see it early to be able to move patients. And this is where our payer relationships are paying a lot of dividends, because they have a lot of interest. Some of these payer groups feel like they could have significant quantities of precognitive impairment Alzheimer's, when you think that you could detect it 10 or 15 years before dementia. And if you can get a drug approved that can stop the progression, what you basically could do is use early detection methods with our biomarkers to reveal which members have the specific Alzheimer cascade before any impairment cognitively. And then if you can get them on a drug that stops the progression, in effect, you can prevent a lot of…

I have no further questions, sir. Do you have any closing remarks?

Perfect. Yes, I just would say, we really thank you for continuing to invest in Quanterix and understand our story. We feel like we have a duty to try to help the world through a lot of the opportunity that these plasma biomarkers are creating for neurodegeneration COVID and longer-term oncology. And we really appreciate the opportunity to continue our collaboration with the investor community. So thank you very much for today, and we'll continue giving you updates. And I wish, once again, Amol and Shawn Stetson, great luck in their next chapters in each of their careers. Thank you very much.

Thank you, ladies and gentlemen. This will now conclude today's teleconference. Thank you for participating. You may now disconnect.