Kevin Hrusovsky
Analyst · Cowen
Great. Thank you very much, Amol, and appreciate everybody joining us for this important conference call of our Q1 and Q2 results – first half results. The Slide 3 shows an agenda. I will discuss the vision and strategy, both the executional side of our business as well as the aspirational value-creation side, talk through first half strategic advances and highlights, as well as some of the second half growth and strategic catalysts that we feel will be highly productive for investors, as well as for our customers. We also then will follow-up, Amol will describe and provide more details on the financial report, then we'll open it up for Q&A. On Slide 4, this is a slide we've used in the past, but it shows how the evolution on the left-hand side of this exquisite sensitivities occurred for digital biomarkers that Quanterix has disruptively advanced over the past 10 years, starting – you can see back in the 1970s, there was nanogram per ml levels of sensitivity. And then through the last, I'd say, 20 years, there's been this picogram per ml capability that several of the customers – companies on the left hand were able to achieve. And on the right, you can see Siemens, Roche and Abbott have utilized these technologies for immunoassays and ELISAs in the diagnostic industry. It's about 200 approved proteins today, but there's probably around 1,300 of proteins that are researched in the RUO markets on the left. But the real breakthrough came when Quanterix started to advance by 1,000x since 2014, another 1,000x into femtograms per ml, and we believe that unlocks the potential to see as many as over 10,000 proteins in research markets that could lead to as many as 1,000 proteins in IVD market. These are all estimates, but we also just announced about 2 months ago that we've also achieved a 100x greater sensitivity beyond the 1,000x. So this is really continuing to allow our technology to advance. And on the right-hand side, you can see the vision that we've been able to achieve utilizing this exquisite sensitivity. And the real promise is to go from late and invasive sampling, whether it be biopsies or cerebrospinal fluid taps, go from those very intensive or even imaging invasive samples to really noninvasive blood samples, saliva, urine, and allowing you to see disease earlier with a less invasive sample. And you can see that those two combined dimensions earlier and noninvasive allow, we think, a breakthrough in medicine. In this slide that we now have up, Slide 5, just showcases – you can see on the X axis the stage of detection of a disease. And the later you detect the disease, typically, the harder it is to treat. So, late intervention leads typically to very bad and expensive outcomes. And cancer and neurology are the latest many times to be detected, and that creates a lot of costs in the health care expenditure. You can see on the X axis, though, the red and the blue boxes down below the axis, that's the level of detection just illustratively of our technology. And the key here is that if you want to see disease earlier, the protein concentration is going to be much lower when the disease is very early stage. Baseline levels when you're healthy are the lowest level of proteins, and that's typically a level that most technologies today cannot measure. And then as you get sick, the concentration of those diseased biomarkers increases, and today's technology in red can't see them, but this is late stage. Then on the left-hand axis is the invasiveness, the Y axis. And you could see the same phenomenon. When you have a very intense, invasive sample, you have very high concentration of the protein. But if it's a very low invasive like blood, saliva, urine, the concentration is much lower. So, the key here is the blue boxes is what Simoa enables, allows us to reach into earlier-stage detection with less invasive sampling. And you can see the number of third-party, peer-reviewed publications now that are showcasing our ability to do this in cancers. Clearly, neurology has become one of the big focal areas. It's easy sometimes to see the disease in the cerebral spinal fluid, but it's a very invasive sample. Seeing it in blood with correlations is what we've been able to do now. And now there's a lot of publications leading to many drugs being tested using these biomarkers. And one of the newer areas that we're really reviving, we did a lot of work with HIV, but down at the bottom, infectious disease, and you can see the coronavirus, there's a lot of publications now on our ability to see this coronavirus, as well as infectious diseases earlier. This next slide is pretty important. We've been showing this for the last six months. On the left-hand side is what we call our research market, which is primarily a low-risk, high-growth opportunity where execution is paramount, and we believe there's a good 2x to 3x of value creation here. And a lot of what we're doing is catalyzing drug development by being able to allow our pharma customers to recruit patients using our technology in earlier in the disease cycle using these biomarkers. And when you can recruit them in less invasively earlier, it gives the drug a better chance of being efficacious and at a lower dose, which reduces its toxicity. And so the pipeline is very rich. We've been validating this technology, and we've been funding a lot of our company with nearly $300 million of raises over the last 5 years since I've joined. We have a very experienced management team, Board, and our founder founded Illumina, as well as Quanterix as well as many other companies. And so for the past six months, we've been talking about staying focused on neuro, but then also having a CAC pivot, which stands for COVID accelerator in China. And we've made great advances in all of those areas, leveraging this ecosystem called Powering Precision Health of KOLs that allows us to quickly commercialize our technologies. In the area of neuro, you're going to hear we're making advances in Nf-L, and now pTau, as well as the HD-X for those different biomarkers. In COVID, we're looking at both antibody, as well as antigen testing as well as the innate immune system. And now we can even see Nf-L neuronal death starting to occur in COVID patients. And so we've got researchers, third-party researchers now that are measuring axonal death in COVID patients from the COVID virus hurting the neurons, and we can see it in blood again. Accelerator, we've used to really grow our business during the last quarter or two. We expanded it prior to the COVID pandemic, but now we've secured a large payer group, one of the largest in the world, to do major population studies inside of this Accelerator. We also are announcing today, in addition to that large payer group contract that we won, we're also announcing that we won at the NIH RADx program. First, work plan one, and we're in – we've been notified that we've won the award, and so we're now working in that work plan one. And we've also secured some major pharma deals relative to the biomarkers being used, particularly in neuro, and continue to evolve the Nf-L in the potential for companion diagnostics, and we're building our China channel aggressively. So, let's go back 5 years. We really didn't have revenue, and this past year, we had $57 million, we've raised, as we mentioned, this level. And our valuation has continued to increase. Today, it's roughly at these levels of value. And our outlook, we believe, is solid in this research market, we got about 10% penetration, but on the right-hand side is the aspirational side. And interestingly, we think COVID in this crisis, as we've mobilized our company to try to help fight this crisis and get the world back on its feet with better testing; we actually think it's further showcased the brilliance and the capabilities of our Simoa technology. As you know, two years ago, almost two years ago, we regained our rights to go back in to IVD. We had sold the exclusive rights to bioMérieux, but we've retained those back. And that – since then, we've been advancing our serum Nf-L for MS and for brain health, and we've always felt that there's potential for an IVD partnership to replace bioMérieux, and we bought Uman, and we've subsequently licensed to Uman the Nf-L antibodies for a future IVD test for MS and other brain function tests that Siemens is interested in. So, we think our diagnostic strategy is gaining validation, and it's helping us see the potential of COVID, we mentioned the NIH grant we won and the momentum of exposure to the NIH so they can see now what our technologies can do. These large payer group studies that really are based on finger prick, getting capillary blood. We're pretty excited about the infrastructure being built out to support that payer group studies and building out the capability because we think it's a key opportunity and franchise that our sensitivity enables is the ability to get an answer from a very small sample. And then in neuro, we continue to have opportunities to evolve into drug trials, and you might have saw on the front page of New York Times, the discussions around pTau, creating a lot of excitement for a blood test that could maybe screen for Alzheimer's. And in that particular article, they are talking about seeing Alzheimer's maybe as much as 20 years before dementia. And then the Nf-L also is playing a role in both Alzheimer's disease, as well as MS drug trials. And the validation of normalcy studies have continued to evolve as well for Nf-L, allowing us to further pursue FDA sanctioning of that technology, particularly in a single-site LDT lab. We also saw drugs get approved using Nf-L. Roche and Novartis both had Phase III trials and drug approvals, and that's a pretty important breakthrough for demonstrating the value of our Nf-L. And we'll show you that more in a moment. But we do think there's potential, not only for the partnerships that we mentioned in IVD, but also working to license the pTau antibodies for some of these newer opportunities to see Alzheimer's and blood, and we think it's game changing. This is a slide we've also shown. Left again is execution. We've added in here COVID, which we think COVID markets and research are about a $200 million market opportunity. And then you can see we move that across to the right. And if you add COVID and what's been going on in COVID diagnostics, we now think that the overall TAM opportunity, longer term, when we look over into diagnostics, the approachable market here, the opportunity for a TAM can actually go up from $40 billion to $55 billion. So, we continue to see a lot of positive movement. And you can see the dispersion of our technologies and where we're deploying them in this build-out, and you can also see our penetration in neurology is less than 10%. And we intended to go into oncology this first half, but a lot of those oncology labs shifted over and became COVID labs. So, it's actually allowed us to showcase our ability to measure the immune system with our technologies, which have been very productive. This next slide just walks through COVID, neuro, and platforms. There's some pretty important advances here. Simoa is potentially holding the keys to some high-definition testing in the COVID world. We're going to talk more about that. We also see it as an attractive entry point to precision health and vision with this large payer contract that we won in the last couple of months. Game-changing, home-based antigen test in blood is being looked at as a major opportunity with this NIH RAD feasibility study that we've also won and are currently doing work on. And then we've won a lot of large accelerator deals with strong growth occurring in the first half. And that second neuro area, as we show, compelling neuro toolbox continues to evolve. We launched pTau-181. We launched the 4-Plex. We're working on pTau-213. So, there's been large drug studies also for Alzheimer's and MS that we are seeing in the outlook, which is a very big opportunity for us. Nf-L, pTau also is getting more validated, and its clinical potential is beginning to be more ascribed as these publications continue to amass. And we've also seen these drug approvals that we mentioned which we think is really exciting. And then on the platform itself, we got the 100x sensitivity. We've got IVD licenses with Siemens, and there's more interested for Nf-L, as well as we think there's potential for Simoa license more broadly with an IVD partner. And then HD-X is delivering on the promise that we said around increased reliability. And our Powering Precision Health syndicate continues to grow with many webinars and different levels of communications coming from these KOLs and podcasts, helping the world see the way our technologies can disrupt. This next slide just shows that there's a lot of different technologies that have been approved for COVID in virus and an antibody. And there's a lot of challenges still as we see in many of the publications around those technologies. And so this next slide illustrates that those barriers of invasive testing, when you have to use PPE to take a nasal swab, there's evidence of some false positives and negatives due to sample collection challenges, makes that somewhat unreliable. The lack of quantitation, low throughput, high cost, many of those barriers have the potential to be moved positively by our Simoa solutions. And that's what we're currently working towards, and it was great to see the NIH validation of that as well as the UnitedHealth Group validation. And this slide has been used over the past six months as well with many of the seminars we've had for COVID. You can see the early interferon innate immune response to the antigen, which is, in fact, the virus, which sits in the center, and then you can see the peaks of the adaptive antibodies, which is serology on the right-hand side. And our initial volley into this with the NIH is looking at this high-sensitivity antigen. We also are working towards a high-definition serology capability from an RUO for vaccine producers. And then the innate immune system, we've already seen a lot of stratification for cytokine storm using our technology with many researchers in the hot zones. And we mentioned the Nf-L being looked at for measuring the impact of COVID on the brain. And Number 5 is really the ability potentially to look at all of these areas simultaneously, if you could do the testing and the samples to kind of get a much better picture. And we're starting to see some publications from some of our KOLs in the PPH ecosystem using the HD-X showcasing different types of testing that they're able to achieve. And we think that comprehensive testing is going to be needed to really understand what's going on with this virus. When do you have immunity? How long would that immunity last? Will you have re-infection? There's a lot of deep questions that need, we think, better technologies and testing to answer. This is just a summary of all the different companies, an example of all the companies in our PPH ecosystem that are deploying our technology and helping us further advance it. And this is just a slide to discuss, we think, a breakthrough in these past couple of months when we signed this contract minimum of $1 million of population studies with a – one of the largest payers in the United States or in the world. We think teaming up directly with the payers who are really trying to create outcomes and then utilizing this Quanterix vision, where you can see the disease earlier less invasively and potentially with home sampling, leads to this partnership opportunity where we've already signed one contract. But we see on the left-hand side, there's millions of members in these payer groups, and their goal is improved outcomes, as is our goal. And finding the biomarkers that enable that and then having the drugs available when the biomarkers reveal early detection, those are the key components. And this slide further illustrates across all of these different areas. We've got biomarkers today that we can start to deploy, and we're starting that out in COVID, but longer term, we think that even for areas where there's top disease costs, where there's not biomarkers, we think discovery, working with these payer groups could lead to further advances in that biomarker menu to enable this kind of visionary opportunity for baseline assessments and early detection. I wanted to show, in the area of COVID, the breakthrough of doing finger pricks, we think, allows home sampling, eliminates a lot of this challenge that health care workers have wearing PPE to do these nasal harpoons to try to get the infection on it. And you can see that there's, on the right, a lot of challenges with false negatives and positives and work exposure that have been evidenced in publications, and we're trying to try to use our technologies to see if we can create a breakthrough by seeing the virus and the antibodies in blood, which we think, particularly the virus could be a major improvement to sample testing and its ability to be scaled, less worker – health care worker exposure, more convenient, lower cost. We think the supply chain is also somewhat distinct. This is a couple of publications. One of it is dated back to 2004, where they were able to see SARS-1 pretty productively in blood. And now we've got a game-changing publication that hasn't been published yet, but it's been issued for preliminary review, and that made it public, where they're able to see antigen in blood approximately 60% of the time. So pretty excited about the ability now to see SARS-CoV-2 using the Simoa technology in blood and the potential that, that could have for advancing the research markets as well as some day, maybe even the diagnostic markets. And these are opportunities, we think, if you did drive blood spots, you could then courier them into different laboratories, centralized laboratories that currently are able to do a lot of testing. And within a 75-mile radius of these current reference labs, you can probably get to half the population of the United States. So, we're looking at these different avenues in our work with the NIH as we try to build this out. This is interesting. A publication just came out in the Journal of Neurology, where you see a lot of symptoms of loss of smell, taste, headaches, insomnia, cognitive impairment. And again, they're now showing a direct correlation to these symptoms with our Nf-L in blood. So, this is going to enable, not only short-term exploration around these issues with axonal damage from the coronavirus, but more importantly, what's the longer-term impact. There's a lot of individuals saying they didn't have really symptoms, but they're now having neurological symptoms and brain fog. And so, we think our Nf-L can play an interesting role there. And then just going full-fledged into the neurology side of this, these are these products that the top 3 that we've already launched, and pTau-217 is something we have under work, and this is that New York Times article. Amazing, isn't it? Long – saw blood test for Alzheimer's in reach. And so, our technology, the Nf-L and the pTau Total and the 181 were showcased there, but we also have a lot of work out that we're doing in that 217 area and believe that, that's a big area for our future as we got the greatest sensitivity to see these biomarkers in blood. And then finally, in this area of diagnostics, I just wanted to further iterate the possibility and promise to further advance the IVD markets. And we've been really establishing a lot of validation in our RUO markets. And you can see here, there are four top players in IVD that make up probably two-third roughly of the revenue. And those companies typically have a core labs and a point-of-care position. They're stable, growing and they're attractive markets, but they've got high barriers to entry, very expensive. And so since we've recaptured our rights, and we've been able to prove all eight of these checkmarks on the versatility of our technology, we think that the advances we've made with this large payer group, NIH RADx program, the major pharma advances with Nf-L and pTau and all the publications that we've been able to validate Simoa in RUO markets, we think it opens the door now better than ever before for a win-win opportunity for an IVD partner relationship to mitigate some of the risk and create the upside of their ability to penetrate those IVD markets. So, relative now to Q2 specifically, I wanted to show that the publications now are approaching 900 third-party, peer-reviewed publications. You can see 500 of them are in neurology. And you can see the number of biomarkers in the second category. Those are what's fueling our growth. And you can see the Accelerator growth. We almost have had year-to-date revenue almost equal to what we had all of last year. So, we're making good progress and continue to want to grow the Accelerator with a lot of opportunity and projects. Particularly, when many of these labs are shut down out there and the HD-X is being revalidated, we felt that the consumables, we knew that they're going to be a little bit off when we had the revalidation of HD-X. But with the pandemic hitting, we've been able to really keep a lot of that consumable flow, doesn't show up as consumables, but through our Accelerator. And that's been key for us during this pandemic time. And you can see the number of instrument placements has been pretty significant for the first half of the year, and our total revenue, we're around $29 million for the year. And then if you look at the specifics, you'll hear more from Amol on this, while we knew that we would have an off first half due to some of the HD-X revalidation, the pandemic hit us hard, primarily in Q2, but there's a lot of strength in our business, particularly in June as we continue to then evolve into the second half of the year with a lot of growth catalysts, as we mentioned, those major contracts that we were able to get approved in the latter part of Q2. And so instruments, you can see the growth was 2%; consumables, minus 34%; and lab services was plus 33%. First half of the year, lab services, other services is plus 60%, minus 17% and then 7%. And we're going to see, we think, in the second half a resurgence of many of these pieces of our business as we're already seeing evidence. That's assuming that the coronavirus doesn't have a major secondary relapse and an economic issue on our customers where, right now, most of them have been opening back up. This graph just shows the demographics on Slide 22 of how our business is currently stacked up. And you can see that North America grew 27%. Europe and Asia is growing faster. This is the last 12 months average. And you can see our customer groups at pharma; biotech is growing around 30%. Academia, a little bit faster because we've launched products to further cater to them. And then in the disease category, as you can see, neurology does overwhelm, but we are evolving our oncology position, and COVID will also play a role moving forward. These are our three products, HD-X, SR-X, SP-X. We've already discussed kind of at year-end where we think we'll be. We feel still really good about the targets that we set at the beginning of the year for HD-X in both trade-ins and new sales. And the SR-X has been very hot, 120-plus installed in 2019, and we're off to a very fast start, very strong quarter in Q2 as well. We don't provide granularity on those numbers, but it was a very strong quarter. And the same with SP-X. And then you can see our plate and bead assays that we have and then the Accelerator itself working towards CLIA and LDT capability by year-end. This slide shows all the companies that are currently utilizing our technology for primarily drug approval, research as well as diagnostic longer-term research, improving both efficacy and toxicity with a 300% improvement and overall probability of a drug getting approved in a Phase III, if you use our technology after a Phase I or starting in a Phase I. This probability improvement by lowering toxicity, increasing efficacy, has really been the driver of our growth on the left-hand side for the execution. And all of those companies now presenting at PPH and further validating the ability to use it and that research markets has allowed us to keep evolving our business. And you can see the number of CROs now that are using our technology. And we've actually completed 118 major Phase I, II, III trials in Quanterix since we started running them in the Accelerator. Key to this, as we've mentioned before, is that the FDA has really sanctioned new biomarkers, particularly for neurology, because they see a lot of neuro health as a national priority, given the COVID long-term impairment, veterans post-traumatic stress disorder, the opioid addiction, the rapid ramp in Alzheimer patients over the next 50 years and then many of the mental issues. The cost burden is extraordinary. So drug makers have been looking for objective biomarkers. And we really broke through in MS first, and now we're starting to migrate into Alzheimer's, which is really exciting and that's the rapid adoption, and you can see in Number 2 of those markers. And in the area of Nf-L, you can see we've had a very rapid ramp in publications. 42 MS publications and clinical trials. And it also branches into Alzheimer's, ALS, Parkinson's. So, Nf-L has really been a big winner. And this is the two drugs we mentioned earlier that utilized our technologies, either as a surrogate, secondary endpoint or primary. And you can see that these drugs are being approved this year. And without the Nf-L, it would have been hard to have gotten them approved this quickly. And this year, coming up to ECTRIMS on Slide 29, we're actually going to be showcasing this study, which is the normalcy study for Nf-L that is a key to advancing our clinical validation with the FDA. And there's going to be a lot of fanfare. A lot of our customers will be presenting data at ECTRIMS around this study and many other studies using Nf-L. In Slide 30, you can see we are just continuing on our road map to build our neuro-based biomarkers. On the left-hand side, you can see there are a lot of neuro toolkits in the cerebral spinal fluid, but that's a very expensive, invasive and really somewhat dangerous sampling technique. And across all these different diseases, on the right-hand side, you can see now the ones we can do in blood, and we're continuing to mount our advances in pTau is the most recent category where a lot of our future growth over the next, I'd say, six quarters, you're going to see a nice spike in our pTau with the launches of 181 and eventually 213. So, in summary, I would say on the left-hand side, the execution continues to flow with neuro plus the CAC pivot. And on the right-hand side, our aspirational opportunity continues to accelerate, given what we're seeing happening with COVID and with our neuro panels advancing in the clinic with many of the drugs. So, we would like to summarize, we have a category changing, defining sensitivity and technology. This market is evolving into a larger TAM opportunity. We think we've got tremendous validation, 19 of the top 20 pharmas. We have all of those publications and now close to 900 of them; and all the drug trials, nearly 1,000 of them. So this is key to our continued evolvement. We've invested heavily in the growth of our products so that we can have a razor-razorblade approach, and we're seeing solid returns from this growth, and we do think there's a good commercialization track record with this group that we have. So now with that overall summary, Amol, I would like to turn it over to you if we could then talk more specifically around the Q2 financials.