Kevin Hrusovsky
Analyst · BTIG
Thanks a lot, Amol, really appreciate it and welcome to your first call, Amol. We are excited that you have joined Quanterix. And today, we're going to go through the same agenda that we've gone through the last several quarters, where I'll provide highlights of the quarter, update you on the goals for 2019 and make sure that you understand the aspirational dimensions of this company and the possibilities around transforming medicine, starting with neurology moving on to oncology. And then, Amol will provide a little bit of a detailed look at the financials and then we'll wrap it up with Q&A. So my first slide, there's a deck that we're following here. It would be considered Slide 4 in the deck. Basically, upper left is the sensitivity of our technology that we are exploiting to create some new markets that we are gaining very rapid position within. In the middle of this slide at the top, you can see that we're starting with neuro, but we're going to be adding oncology and we're actually starting that addition of oncology this quarter with the launch of a whole new platform of technologies for oncology. We believe oncology is 3x the size of neurology, but we also believe that there's more competition in oncology. In neurology, we're a first mover making great strides. We're only 5% to 10% penetrated in neurology. So, we still got a long way to go. But the way we are deploying this is we're starting in research where there's no regulatory or reimbursement risk, and we're evolving the size of that market by moving into services. And in this case, pharma services, getting drugs approved with a much higher level of probability is key to the value proposition. We ultimately, however, bring biomarkers from this research market where we've got instruments deployed around the world and we've got some of the top thought leaders around the world looking for new biomarkers. NfL, neurofilament light, is an example that three years ago, we hardly had of any. And one our customers used our homebrew and uncovered it and we basically now -- this past quarter, I think we actually doubled the size of our products, many of it is due to the rapid ramp-up of NfL, neurofilament light, being able to look at neuro and axonal health and damage of the brain non-invasively in blood. So ultimately, we are going to be deploying these markers and a diagnostic strategy and we've got all those rights back in September of 2018. And so we're working and using some of our investment funds today to go about what we consider to be a crossroads into that diagnostic landscape. So, overall, on the right-hand side, the arrow is just depicting the fact that everything we're doing today is research. There's no regulatory reimbursement risk. And you can see the consistency of the ramp that we've been projecting. We've been saying that we would be able to grow 40% in the long-term despite our base getting bigger. And this quarter is a good example where we were able to grow at 64%. That's 70% if you exclude collaborations. And every quarter since we've gone public, we've accelerated our growth mainly because many of our investors own pharmaceutical biotech stocks and they want those drugs to get approved. And so they've been very helpful. Our investors have been helpful in introducing us to key clients that are trying to get those drugs approved. We've created a win-win and have many investors actually helping create value for us by getting those introductions into pharma. Some other highlights other than the growth is our gross margins. We had a 700 basis point improvement this quarter. Some of that's mix and you'll get into some of this with Amol, but the consumable is a very good mix move for us, as we've stated in the past. Amol being with us is one of our big wins. He's got a lot of experience in pharma where we're actually playing this out, as well as in specialized CRO services. And as we scale our company, he's got all the skill sets to help us scale and keep the predictability that we've always been able to have with very strong execution, but still maintain the aspirational opportunity that we know this company represents. We also hired Mary-Ellen Cortizas that's running our accelerator lab, and she also brings the clear capability that came with Aushon when we made that acquisition a little over a year ago. Also, as we mentioned, we launched not only the SP-X for oncology but we launched many assays into oncology that are going allow us to have another growth catalyst for oncology. But interestingly, the thing that we've really brought a lot of focus on are the third-party peer review publications to validate our technology. We've never had this level and this number of publications in one quarter, but 61 new publications occurred. So there's a now tsunami, avalanche of publications starting to come out, which is a lot of the Powering Precision Health investment working with all of the thought leaders around the world with our technology. You may have seen us on CNN where one of our neurologist teams in Europe was able to identify elevations in NfL in familial Alzheimer patients 16 years before symptoms. And this is consistent with what many of the Chief Medical Officers of our pharma customers that are in neurology have been saying that seeing these diseases much earlier will allow a whole new drug strategy for getting drugs approved, which the FDA has now issued guidance, actually enticing companies to have biomarkers to reveal disease long before symptoms so that it can be a much easier pathway for pharmas to get drugs approved. We also interestingly found a marker. One of our cancer teams at the Salk Institute found an LIF pancreatic cancer marker, which they think is going to be a great drug target for advanced stage pancreatic cancer. So again, these are examples of how the technology is revealing special opportunities for drug discovery and development. The next slide just illustrates what we've basically talked about, but it does break down the instruments in the consumables and the services. We look at our services as primarily a swing capacity of opportunity and with major surges of growth like what we saw in Q1 where our product revenue basically doubled. We're able to deploy some of those service opportunity -- those service resources to help fuel and fund and resource many of the, what I'll call, significant trials that are beginning to happen in NfL and in related neuro markers. And the high margin is really a result primarily coming from the mix effect of growing the consumables so aggressively. So this next slide is probably the most strategic and it basically illustrates the secret sauce that we've had laid out back five years ago when we came in was publications would be the key to identifying key biomarkers, which then will be the key to enabling studies to be done in our accelerator, which then would lead to instrument sales, which then finally will lead to consumables sales. And you can see that we have two quarters now of very rapid growth in our instruments. I think we're averaging about 70% growth over the last two quarters and that's a major catalyst because we were flat on instrument placements for about three years and so we started to see the second half of 2018. And then, you can see that we're having very strong consumable growth. There is some favorable timing in that consumable growth by being able to cater to some of these major trials, but we also know that there's a lot of new trials that we're trying to source going forward. It makes us very bullish about our ability to continue very good growth trajectory and to achieve all the growth targets that we said we would be able to do for the year. And the accelerator continues to not only add more studies, but we're also doing Phase 1, 2, 3 trials in-house primarily for neurology. So, we are now over 500 third-party peer-reviewed publications further validating our technology. Next slide just illustrates the geographic, the customer and the disease breakdown. And you can see that 77% in Q1 was in neurology. We are starting to see some oncology 17%. Our customers, we had faster growth in pharma/biotech primarily because of these larger trials. And geography, we are starting to focus on Asia and you're starting to see that up tick. The next slide shows you the goals that we set out to achieve for 2019. We are on schedule or ahead on every single goal. So, we're pretty excited about the very fast-paced launch that we had for the SP-X and the CorPlex assays in the oncology segment. But in every category, we give ourselves a green light for Q1 meaning that we're making great strides across it. So now I'd like to turn to just make sure you have a good feel for what it is we're doing to disrupt the industry. On the left-hand side, you can see today for cancer and for neurology, it's very invasive to determine what the state of a patient is relative to disease. And it's normally very late stage, stage 4, when you see it. And our goal was to move it to blood-based, less invasive saliva-based testing that gives you these biomarkers in a much less invasive way so you can see disease much earlier with our exquisite sensitivity and the less invasive the test, the lower the protein level and the earlier the disease, the lower the protein level. So that's, in the highest level, the way we've been able to deploy our sensitivity to create a differentiation. And that's what Slide 10 illustrates and we're primarily focused on cancer and neuro. And the next slide basically takes those same categories and shows also about the bottom, what we consider the size of the biomarker market to be inside of these diseases. And cancer, with liquid biopsies continues to be an area that we think is going to be a very large opportunity for our company as time goes on. In neurology, we now think we can see a $6 billion opportunity between research and ultimately diagnostics. And we now got 170 pubs in that neurology area, 50 different biomarkers looking at brain health from different vantage points and we'll talk more in a moment. The next slide just illustrates the different ways we bring revenue into the company, starting with instruments. And on the slide, you can see there's two new ones in blue that we're launching. We launched the SP-X end of Q1, early Q2 ahead of schedule. And the HD-X, we're projecting by year end, in Q4, we'll be launching. We're real excited about that being the next generation of HD-1. And the assay kits, they're not just bead-based now but they're also planar and plate-based. And on the right-hand side are services, which you can see in bold at the bottom, they also now have CLIA and LDT capabilities, which allows us to work closer with pharma on getting these drugs approved. Key to our strategy is continuing to invest in sensitivity given that we can exploit that in a lot of different ways. And so Slide 13 shows, on the left -- on the Y-axis how sensitivity is the key to the third-generation instruments that we created where we would say Luminex had the first generation, and then, second generation was MSD and planar. We now have both bead-based of Luminex and planar-based of MSD and what we would consider to be third generation bringing sensitivity. But at the upper right corner, you can see we are making investments to have by year-end 2021, another 100x. And already in prototypes, we've gotten to 10x additional sensitivity. So we're very excited about the continuation because today many of our customers in neuro particularly can see things in the cerebrospinal fluid that are subsets that indicate those subset isomers indicate different fractionations of the different neuro diseases that they cannot see those proteins in blood today, a 100x sensitivity increase would enable us to see them in blood. So that's why we're really excited about how that will engage the next frontier of medicine. And we do think -- this continued to show the slide where it shows where -- our sensitivity is the most important thing, but dynamic range and automation, ease of use and the precision of the sensitivity are all very important differentiators from the competitive platforms. The summation that we showed earlier is that by having the sensitivity and deploying it, it not only increases the probability of getting a drug approved by 300%, but it really hones in on lower doses because diseases are caught earlier. That makes the drug safer and less toxic and increases the efficacy by being earlier in a disease cycle. And that's what the FDA now is encouraging pharma customers to use biomarkers to get drugs approved because it can make the drug safer and less toxic and more effective. And on the right-hand side, you can just see an update that there's now 38 different machines out in CROs, like the LabCorps, the Quests, the Rules-Based Medicines from Myriad. These are incredible institutions running these Phase 1, 2, 3 trials for our pharma customers. You can see the number of those trials. The next slide just updates you that the FDA continues to issue guidance on biomarkers and one of the more interesting one when you consider the failed beta-amyloid, anti-beta-amyloid drug from Biogen about a month ago is that they're really encouraging looking at stage 1 and 2, which is pre-mild cognitive impairment. Before that symptom, if you can have biomarkers ruling on that and then you can affect those biomarkers with your drug, it represents a new opportunity. And so we actually think there could be a lot of drugs that have already been tried that could not be efficacious for Alzheimer's. Maybe if you can get to the disease earlier, those could be brought out of what we would consider to be a failed drug into a positive drug. The next two slides just show in 2014, we just had a few customers bet on us, but you can see how that's ramped up and it's pretty broad-based, which gives us great distribution, not a lot of concentration in our business, which we think is important. This next slide just illustrates all the different categories of biomarkers in the brain that we see a lot of interest in. And the one that we have spent a lot of time in is the axon where -- and the neuron where we're using this neurofilament light. And the next slide just shows you how rapidly the publications across these different disease categories have evolved and that's also led to the markers growth and then the instrument installed base growth, which then leads to the consumable growth. This next slide just shows you how in the last two years the ramp of neurofilament light publications and I call it the three shots on goal. MS, TBI, traumatic brain injury and Alzheimer's, all three of them basically destroy neurons and that gives our technology an opportunity to look at disease progression. In all those pharma customers on the right, there's 46 active trials right now utilizing the serum NfL, which are the standard best in case. The next slide just illustrates that NfL is not just for MS and TBI and Alzheimer's. You can see ALS and Parkinson's and others are now beginning to evolve and we really believe that neurons get damaged across all of the different neuro diseases. The next slide just illustrates for later -- some of the publications that are coming out. One of them is for Alzheimer's and one's for MS. These are game-changing pubs. We were just at AAN this week and there's just a record number of Simoa presentations on neuro. You can see the rapid ramp on Slide 24 of all those publications using our Simoa technology. That led us to do a major trial across the globe, 17 different sites and we've got great uniformity across all 17 sites showcasing the analytical precision of our technology. And this next slide is a normalcy study that we would like to run with 18,000 normal patients and we're going to do this with collaborators. Jens is one of the top collaborators in the world, as is Professor David Leppert. But to run a normalcy trial, so we can see the normal levels of NfL from age 7 to age 70, that will be the baseline that will be used to -- say, if you're above that, there's likely some issue going on that we would then want to further dive in with specificity. These next two slides really deal with the 16-year before symptoms for Alzheimer's and that recent study that was published that gave us a lot of good press. The slide after that just shows that someday, we think that what's being done with the PET scan, there's evidence for tau and for beta-amyloid that that could be done in blood or cerebrospinal fluid with our technology and we're going to continue to make investments working with pharma to help on that front. And aducanumab from Biogen was a great example of maybe where we think other technologies, biomarker technologies, could play a role as many other drugs for Alzheimer's throughout the industry. And you can see that there's a lot of what we'll call breakthrough status designations being given by the FDA for anyone that can measure these biomarkers in blood for Alzheimer's. It's somewhat of a national priority. The next slide is the final neuro slide that says that we're also working on concussions and the role that we think our technology can play in here. There's a major trial the FDA is funding right now, TRACK-TBI, that's using Simoa to get a database of NfL data, as well as a few other markers for concussions. And then the final slide on applications will be this pancreatic cancer publication just came out a week ago. We're really excited about the promise of now moving into cancer. So those are the high-level summaries that's keeping our overall strategic vision going. What I'd like to do now is turn the table back over to Amol to now go back through these financials in a little bit more detail. Amol?