Kevin Hrusovsky
Analyst · SVB Leerink. Please proceed
Thanks a lot, Amol. Today we are going to go through the agenda that's up on our website. Basically, I'll describe the strategic and financial progress that we are making, and that's occurring on just about every front. In addition, I'll provide some very specific commentary regarding the Q2 results and then how that stacks up versus the goals we've set for the year, but I'd like to end my remarks just describing the real important progress that's being made around transforming neurology and the way our technologies are interacting with healthcare. Let me start with just the highlights for the quarter. You had 57% revenue growth, which, for the first half, that's 60%. As you can see on the right-hand side of the graph, we've continued ever since going public, where we have a lot of investors supporting us and helping us in our business development efforts. Many of them own pharma biotech companies that are trying to get their drugs approved and that plays right into what it is our technologies can achieve. And so, having owners in our company that also own pharma/biotech has been very productive in the overall business development initiatives. We also are really excited about the progress that we are making on gross margins and this does not include any of the Uman benefit. But once again, we've delivered a very strong 500 basis point improvement in our gross margins and actually for the first half, it's nearly 600 basis points and it is 580. We've continued to scale our executive team. We brought in Amol, as well as John Fry as General Counsel, Amol as our CFO. And we've recently brought in three key commercial leaders, two of which I've actually had a lot of experience working with in the past. We acquired Uman very productively and were able to use about a third of the consideration that we paid in stock, which was a real nice benefit for our cash preservation. We also did announce that we were launching HD-X a little early, ahead of schedule, as well as the SP-X. Both of them were launched and we are feeling really productive around their launches and it's an important part of our continued growth as a company. We also just moved into a very cost-efficient global headquarters, almost 100,000 square foot. We were able to combine all the personnel from our Uman acquisition of about 18 months ago with those from the Quanterix team. We are all together now in this center for biomarker disruption and innovation. So pretty excited about that. We also had a really strong showing at the recent Alzheimer Conference. We actually ran a dinner session where we had four top thought leaders. I gave a summary of where we are going as a company and then we had a panel discussion that I moderated that was standing-room only and there is a buzz at most of these conferences now in neurology around the possibility of using biomarkers to helping the drug approval, and even use it for potentially, rescue. The next big one is going to be in Stockholm. It's ECTRIMS coming up and we'll talk a bit more about that in a moment. And we've also just continued to have a lot of third-party peer-reviewed publications, which continues to be an important part of our advance. And this next slide illustrates a little bit more breakdown of the revenue and you'll hear more of this from Amol. But that top-line overall growth is a very strong trajectory that's continuing and we would say that, when you look at the right-hand side, what's most notable here is that, our consumable growth once again was above that 40% level that we expect will be the overall average level of growth. And this is, I think, the fourth quarter – third or fourth quarter in a row where we've really been driving that very strong consumer growth, increased utilization of our instruments, as well as a new growth catalyst of placing instruments. As you can see, we've got instrument growth again this quarter. I think that's the third consecutive or maybe potentially fourth consecutive quarter of growth after having three years of basically flat growth. We were placing instruments at a very regulated pace and since launching these newer platforms, we are now starting to see really nice growth catalysts in our instrument volume, which later on translates into consumables, which is a good forward-leading indicator. We also saw the recovery of our lab services growth. We've always been growing there. But we really are trying to stay at this 40% level as well and you can see that, we had a really strong quarter. That's also a leading indicator and parameter because many of those that use our lab services do studies and they ultimately then buy our technology. So we've made that a very profitable, promotional component of our business. We are making great margins on our lab services. But it's yielding a lot of downstream instrument placements. And it's also where we are exploring a lot of the opportunities for companion diagnostics as we continue to evolve our pharma services offering looking for ways to make drug approvals and then, ultimately monitoring patient performance opposite those drugs. We actually feel our lab services business is where a lot of that strategically is going to play out. And then at the bottom, I think it is interesting to note that for the first half now, consumables represents almost half of our company and that has got the biggest gross margin opportunity as we continue to evolve and you can see that our growth of consumables in the first half has been nearly triple-digit. So, just to remind everyone, the overall path that we have as a company is, is that today, when you look at the healthcare industry to diagnose cancer and neurodegeneration, particularly, they don't discover it until there are symptoms and by the time you have symptoms you are in very late-stage in the disease and these are very lethal diseases. A lot of our high-level premise is on the right-hand side of being able to see disease much earlier, much less invasively by using the exquisite sensitivity that we have in our technologies and we're going to now further explore that on this next slide. It's a slide we've used in the past. But the Y axis just shows you the invasiveness. As you reduce invasiveness from biopsies and cerebral spinal taps, I think that these cerebral spinal taps are very painful and they are very expensive and invasive and you actually can create infections and so, most patients will never even allow them to take - even when sick, a spinal tap. So, to see head health today in the CSF, the Cerebral Spinal Fluid it’s a very invasive procedure and the red area in that box on the left is what today's technologies can see, so that's why most of the diagnostics are in highly invasive approaches. Now at the bottom you can see blood and saliva and then the disease on the X axis, when do you detect it? Again, the red area is today's detection capabilities. It's long after symptoms that you are picking up cancers and neurodegeneration. The blue boxes is what our sensitivity does to this slide and it allows us to start moving cancer and neuro into a much better earlier diagnostics with less invasiveness and cost. And that is we believe a game-changer for the longer-term value creation of this company. So the next slide is a systematic roadmap of what we've been deploying. We actually moved out of diagnostics about four years ago when I joined, four-and-a-half years ago and said let's redeploy and research where there is no regulatory reimbursement risk. Let's establish a lot of publications and third-party peer-reviewed publication and validation for the technology in these research markets. And when we started, the research market was around $1 billion and we actually believe that this research market can continue to evolve into much higher numbers as we keep opening up new biomarkers that couldn't be seen before, particularly in blood. But we ultimately do want to return to diagnostics and you can see that that's about a 5 to 10 x value creation opportunity by moving into diagnostics. And on the right-hand side, we are starting with neurology and research and in research, we've got both products and we've got these services - pharma services and then, the second bubble is where we just launched into oncology. You can see oncology, the grey area is about three-times the size of the blue area, and we actually think we have a best-in-class way now with multiplexing through the acquisition of Aushon to get at great oncology research, particularly for immunotherapies, where it's very important to be able to know early on whether a therapy is going to either work or kill the patient. So you can decide what measure should be taken. And then, on the total right, you can see the largest bubble is the diagnostic and the blue area there is where we hope to disrupt first in this diagnostic area, which is in neurology and that's where a lot of the acquisition of Nf-L plays into it. This next slide just shows you the ways we are breaking down and stratifying our growth. So you can see it for the first half. Most of our growth – most of our company right now is in North America. But we can see we are growing very nicely in Europe and Asia and we are building out those estates. From a customer-base standpoint, we're 60% pharma and then we are lesser academia. But we've been working hard with the new product placements to increase the growth in academia and you can see we are having good progress there. And then finally you can see that we are now 97% in neurology and oncology and you can see the beginnings of this fight for oncology, which is the next wave of our opportunity. This next slide, Slide 10, is really a metric. It's for all of you out there that really understand how to drive businesses from leading indicators. We want to showcase that we've really spent a lot of time. We are the lead sponsor and I am the founder of a third-party nonprofit called Powering Precision Health, where we try to inspire scientists to do third-party studies to validate the technology. You can see now that we are close to 600 third-party peer-reviewed publications on the left-hand side, and you can see the domination of neurology and oncology. And then, the second category are the biomarkers that are being deployed inside of our technology. Many times we offer a home brew kit where customers can actually use whatever antibody pairs they want to source and look at whatever protein they want in a home brew framework. We still collect a lot of money and have good profitability on home brew testing and it's a big piece of what a pipeline of future markers are. So Nf-L, three years ago, was a home brew over in Europe and it now represents 20% of the value of our company. So we are really excited about the 20% of the revenue of our company and we are really excited about the prospects of these biomarkers continuing to increase with the publications. And then, you move into the accelerator, which is our services business and you can see that we have continued to grow that and the red line represents the number of Phase 1, 2, 3 drug trials. And you can see we continue to ramp that up now that we had the acquisition of Aushon and it gave us the CLIA lab. And then the instruments placements; you can see that we were pretty flat for many years and then all of a sudden we started to see it spiking up. In 2018 and 2019 now, we've seen some real nice growth. And then on the right side you can see this consumable build out by quarter and it just continues to ramp very nicely and you can see the growth versus the prior year. And the last, I would say, five quarters, we are north of 75% growth. The next slide, Slide 11, just is a reminder of what we sell. We sell instruments; we sell assay kits, which are the razorblades through the instruments, and then we do the services and now we've got HD-X and SP-X on the instruments now launched and the SR-X we launched last year. And then, you can see that we have different assay kit platforms as well for each of the different types of instrument platforms and then the accelerator on the right. This next slide is one that many investors have asked us about over the years and when we first launched our technologies and talked about the need for sensitivity, many of the competitors said, well, there is no need for sensitivity. Well then, we got involved with Powering Precision Health and had all these scientists validate that earlier detection, as well as less invasive detection, coupled with eliminating matrix effects and being able to get answers from very small samples are all major benefits of sensitivity. And so, our sensitivity advantage versus competition has significantly evolved our position. But then we also automated it, created a dynamic range and then we now are moving into multiplexing with our multiple platforms. And I think, three or four of our competitors have exited over the last three years. But we still are showing this slide. So you can see that how this evolves and how our competitive platforms still have major advantages. And we are going to continue to evolve those advantages. As you can see on this next slide, which basically is the goals that we set going into 2019 that we were going to establish. By the end of the first half, we've actually advanced most of these goals at a place where we are way ahead of schedule. So we're really excited about our neurology penetration. We are excited about the beginnings of oncology penetration with the SP-X, strategically acquiring Uman, plus continuing to have a lot of third-party validation of our Nf-L, we'll talk about. And then in the financials, we've had growth not only in the top-line, but also in our gross margins ahead of our original expectations. And then on the technology, we are continuing to pursue a 100 x advance. The next slide gives you a sense of what it is about our technology that makes it compelling to pharma. Over the left side, you can see that toxicity and efficacy are huge issues for many of today's drugs. And efficacy done for cancer, particularly, you are talking about very low levels of probability that the drug is going to work. And in the area of neurology, it's just as bad. There hasn't even been an Alzheimer drug really that alters disease progression approved at this point. So, when you use our technology and you get a Phase 1 approval, there is a 300% increase based on estimates from pharma itself and biotech of the probability increase that you'll get a Phase 3 approval. And on the right-side you can see the rapid ramp out of our technology with CROs. These are the Quests, the LabCorps and others that are utilizing the technologies, as well as Rules-Based Medicine. The FDA, on Slide 15 is now providing guidance saying, we actually encourage you to use biomarkers to get drugs approved because we think you can get drugs to be approved with less dosing, which makes them safer, and they are going to be more effective if you can see the disease earlier via biomarkers. And the next slide just shows how rapidly our installed base has ramped up over the last couple years and we have a very broad distribution now of used cases, and most of those customers – many of those customers come to our Powering Precision Health Summit to give us the opportunity for referenced selling. This next slide just shows that, from a standpoint of – when you have a biomarker that you have launched into the research markets. It's got analytical validity and that is creating a lot of interest and a lot of excitement. Companies like Illumina are primarily playing in the research markets and we are primarily, 100% there today. But as we get clinical validity and you move from the left to the right, the value of your markers go up, and Nf-L happens to be one that we are the only ones that really can see it in blood effectively and repeatably and with a lot of third-party, peer-reviewed validation and that is one of the key markers that we're going to keep trying to move to the right working with the FDA. And you can see on the next slide, the number of publications using Nf-L is growing astronomically right now and ECTRIMS, which is coming up in Stockholm, the next one, I would expect you are going to see it further eclipse the 40 presentations that were in the spring ECTRIMS and on the right-hand side you can see a lot of companies with active trials utilizing Nf-L, primarily for multiple sclerosis at this point. But there is evidence that it can be utilized in many other neuro diseases. The next slide just shows you that if you look at the publications in CSF and blood, you might have a total of about 500 publications. Most of those are using Uman's Nf-L. But then, when you look at how many publications are only in blood measuring Nf-L, you'll find out that 100% of the publications are using Uman's antibody pairs and also Simoa by the way and so that's key to our acquisition. And we spent three years trying to come up with antibody pairs that could relate to Uman's and you can see that, when you look at blood and CSF, Uman stands apart from all of the other redacted places that we looked for those antibody pairs. And so, what's exciting for us is, when you look at the next slide, we see really three shots on goal for our current focus. Obviously MS, because there is already 15 approved drugs, $22 billion of value out there that Nf-L is starting to help patients see whether or not that drug can be effective or not and there is new trials based on that, obviously, but we also are real excited about also Alzheimer's and the beginnings of seeing disease 16 years before dementia was recently read out in a publication from Europe. And then TBI is another area where we actually have primary endpoints currently under way. So on the Alzheimer front, the next slide, you can see that there has been bad news from Biogen on aducanumab. But there is still continued interest, obviously, as 50 million patients, there is a lot of undiagnosed Alzheimer's and there is the beginnings of us being able to see in blood, as mentioned by the CNN report on Nf-L. But also on beta-amyloid, we've got area under the curve of 99% on, kind of first phase technology, which we think someday it can really provide a very non-invasive way that see amyloid beta and amyloidosis early in that disease cycle. So in the next slide we used at the recent Alzheimer conference, there has been a lot of failed drugs, but you still see companies like Eisai going after anti-beta-amyloids and we actually believe that biomarkers can actually represent a platform for rescuing many of these drugs at a later time. So, what I'd like to do now is turn it over to Amol to get a little bit deeper into the financials. Amol?