Kevin Hrusovsky
Analyst · Cowen. Your line is now open
Thank you very much, Amol. We're going to go through three top items here. First I'd like to talk about the Q3 highlights and then how we are stacking up versus our 2019 goals. And then finally, I'd like to discuss the incredible momentum we have in neurology and the upcoming PPH Summit that will further amplify our momentum. We start with the Q3 results we're pretty excited to report that we had very strong growth, 41% on a GAAP basis. There was a one-time collaboration revenue last year from Abbott that does in fact when you remove that one-time revenue, our growth was 62% which is a very formidable level of growth. But most importantly, when you look inside to see how we grew it further bodes well for our future. We also had, if you remove the one-time effect of the collaboration revenue, which was very high gross margin we once again have significantly ramped up our gross margin by over 500 bps, so we're really excited about the continued momentum on both revenue top line and our bottom line gross margin improvement. One key factor that I think came up a lot in our last quarter conference call was the HD-X and expectations in Q2 that we would probably have a fairly significant instrument miss and then Q2, you might remember, we had a very strong Q2 and we further pointed out at that time that we have a lot of diversity of instruments and we feel pretty confident that we're going to be able to continue drive an instrument growth. And I think what you're going to find is that we had once again I think each time we've launched products we were ahead of schedule. So we were actually able to launch the HD-X in Q3 and it was a significant momentum build and you can see in a moment just how strongly our growth occurred in instruments. We also completed the acquisition and closed the Uman acquisition of Nf-L by far the leading biomarker for neuro health that we can see around the world that can be viewed in the blood. We also raised more growth capital. I think we've raised nearly $120 million year-to-date. So we're really excited about having a very strong balance sheet for growth optionality. We also had this continued involvement with all of our key thought leaders around the world in an ECTRIMS, which is a conference focused on multiple sclerosis. We just dominated the meeting. There was 50 publications all coming from Quanterix usage of the Simoa technology and the Nf-L. This is clearly unparalleled level of growth of publications and validation. So I think several of these were from the largest farmers in the world on Phase III trials, which again we did project this for about a year ago that we thought that we would be able to create these kinds of momentum for Nf-L and that's occurring. But most importantly and most exciting for me, is this next item which is that Tatiana Plavina who is an 18-year veteran from Biogen who did a lot of the game-changing Nf-L work and there are a lot of work even for the Siemens agreement that was put in place about a year and a half ago between Biogen and Siemens for a serum Nf-L [indiscernible] a few weeks ago. So, we're really excited to have her on board. It's going to help us further accelerate our ability to try to go for analytical and clinical validation of inefficient of Nf-L with the FDA. And then finally, we completed just this week actually a major deal with Nf-L with Siemens first of the big three to team up with us to utilize our Nf-L coming from Uman acquisitions is literally two months earlier. And we also announced the technique supply agreement for our antibody. So, you can see right out of the gate. We planned on this being primarily a defensive investment. But as we also pointed out, there would be opportunities for offense, clearly we're landing strongly on the offensive side. This next slide I think is a pretty important one goes into the growth breakdown. And when you look at Q3, you can see once again across all three categories of our revenue, we had very strong momentum. But when you look at year-to-date I think the thing that is probably most compelling and represents a long-term major growth catalysts is that our instrument growth has been 70% year-to-date. That is a, an up charge from the previous. We had about three years in a row where we were stagnant on instrument growth and we launched a lot of new instrument platforms and form factors. And that is a significant and move on instrument growth and obviously the consumables continue to keep growing. And then on the left hand side; I just want to point out that gross margin move, which again is somewhat unparalleled unprecedented to be driving year-to-date almost 600 bps of gross margin improvement. Next slide just goes back to the longer-term vision, we said we would disrupt this industry with this technology. And I think you probably have been watching publications coming out around tuberculosis and obviously on the Nf-L for neuro -- neuronal health. And so everywhere you look you see publications coming out a lot of the vision that we've had for five solid years now is to use digital biomarkers to see disease earlier and it's disease cascade and then to see it non-invasively, and that's a see change in the way the healthcare system could be practice because if you can see these diseases long before symptoms, it makes them much more treatable and someday we think preventable. So, this slide is our vision and we're primarily focused on neurology and oncology is our primary targets because those are the diseases that are most lethal and are discovered today very late stage via symptoms and by the time you discover them many times it's too late to do anything about it. So this next slide just shows that the way in which we're a capturing that slide that we just talked about is through what we call sensitivity. It's the ability to see in the blood and to see at a level of sensitivity that no one else in the world can see and by doing so, we're able to get on to proteins at baseline healthy levels and any movement from baseline represents the disease cascades trigger. This is -- we've been talking about this for several years. This is a very disruptive capability and the Powering Precision Health Summit was founded around best principle that sensitivity can transform the healthcare system and our view here with these pie charts is to show you that we're starting in neurology and we're evolving into oncology with the launch of the SPX. But ultimately, we've always said that we would go back into diagnostics and a one year ago we did get all the rights back from bioMerieux to enable us to unleash and unlock value in diagnostics. Up until then, we could not because it was an exclusive that bioMerieux had. So we're pretty excited now that not only do we have this momentum in neurology now and moving into oncology, but we now have the rights to unleash and create value longer term, and what we consider to be the biggest market opportunity. And Siemens move to do a license with us on Nf-L represents kind of our first major agreement in this IVD landscape since we got the rights back from bioMerieux. So we're pretty excited that we're now stratifying this and this is a non-exclusive deal again showing the leverage capability of our technology, meaning that we still have the rights to license that Nf-L technology to other large diagnostic houses. Now going back into the research piece of our business. I would like to illustrate that we are continuing to grow. Asia, and Europe, faster than North America, where we've had our traditional largest installed base, and we launched a lot of form factors that we felt would play right into that part of the world smaller benchtop lower price point. And when you look at the customer growth, you're going to see that academia has been growing almost a 100% this year and this is product growth. And this is an important point because this is where our publications come from. A lot of companies don't realize how important publications are to fueling the growth of the business. And so a lot of our form factor designs we're going right after academia to help with those publications because pharma while they create a lot of value, a lot of profitability and a lot of growth for us in our primary users. Many of the academics are on their scientific advisory boards at those pharma customers and are guiding them into how to utilize these biomarkers for drug development. So we see this as a very forward looking way to grow the longer-term value creation of the company. So academia growth has been pretty significant. Now overall revenue year-to-date from products is about 50/50 split between academia and pharma. And then when you look into disease categories you can see that the neurology is still a very significant piece of our value creation and that's our focus. And we know oncology is got a much bigger longer term opportunity with all the liquid biopsy excitement that there is, with many of the companies in the landscape and we know that many of these companies are looking for blood based markers even companies like Exact Sciences who have built an incredible franchise based on measuring free DNA and store have talked a lot about the need to someday migrate to a blood-based system and we think that that's further validating a lot of our capability by having the most incredible capability to see sensitivity in blood. So, this next slide is our strategic roadmap, we start with publications in the Powering Precision Health Summit, which is coming up again in November in Barcelona, is the way we incite and create a lot of inspiration for these publications. You can see that they continue to ramp very positively and the number of biomarkers being run in our systems continue to ramp as well. And we do have a home brew approach where customers can design their own protein assay with our technology and that actually creates a pipeline for future growth. The accelerators where we run services and actually create demand for our instruments to get paid for. It's our highest gross margin business right now. It continues to grow very nicely. And you can see now we run 81 Phase I, II, III trials in those facilities and that's a significant ramp. In the instrument category, you can see where our growth actually back in 2016 was negative, and then 5% and then 48% and now you can see we've ramped that up very productively for future growth of consumables on the right hand side. And I think that there was questions in the last two quarters and we tried to illustrate that when we saw this huge ramp up of our consumables year-to-date in 2019 versus previous years. We knew we were going to be growing to 40% , 50% level. But this significant step-up was partly due to a major trial that was being run by Novartis and we did explain that then. We're trying to illustrate this with the shaded area here. But overall when you look at that consumable growth we've also been upgrading our instruments in the field. And so we knew that 2019 was going to be a more productive utilization just because we've been improving these instruments coupled in with the one-time effect. So you can see is a very steady growth and acceleration of growth in our consumables, which again is a great testament to the technology actually being used. The next slide just illustrates again we've got three sources of revenue. We're on Slide 10 instruments. We've got now three of them HD-X, SR-X and SP-X. And then assay kits we've got plates in the bead based. And then finally the accelerator services are three revenue sources. And again, we're really proud on the next slide that we were able to launch early the HD-X which is and then unparalleled ultra-sensitivity machine that's leveraging close to 10 years' worth of experience and the productivity improvements coupled in with its flexibility and temperature control, we think set a whole new standard for delivering disruption and a tech -- in a technological form factor that is reliable and this is key and we began shipping in Q3. In this trade-in program we're doing everything we can to accelerate that. The more HD-1s we can get out of the market and replacing with HD-Xs we know HD-X is going to create a lot more consumption of the consumables. And so we're doing everything we can with a lot of prudent investments to try to get that installed base changeover could help -- it could put some pressure on gross margins for a while, but we think it's a very intelligence investment to kind of keep this of engine going for transitioning our installed base. And we know the early access with several of our customers on the HD-X in Q1 and Q2 was very favorable. So we're really excited. In the next slide, it's just to repeat that we've shown each time. What is it we're focusing our investment fund designed to kind of get better at, and you can see we're continuing to focus on multiplexing menu expansion and the overall economics of our technology and sensitivity will always be our focus. And the next Slide. Slide 13 shows all the strategic goals that we laid out for this year. Starting with neurology then oncology and then strategically moving into diagnostics and the potential that we have longer term for diagnostics and then our financial performance, as well as going for 100x improvement in sensitivity to go after the next-generation of proteins that we already have been able to identify the cerebral spinal fluid. Across all five of these categories, you can see we're in green. We've had another incredible year year-to-date on hitting every one of these key goals for the year. Next slide. Just repeat the fact that a lot of the secret sauce of our technology in the way we've deployed it in research is to help drugs get approved by seeing disease earlier you're able to then get a drug under a lower dose and less toxicity to be effective more so then if you catch the disease too late. And this is leading to a 300% increase of probability of a drug being approved, if it gets a Phase I approval if they use biomarkers. And you can see on the right hand side, the CROs are all diving on this. And just one CRO alone has had over 650 clinical trials for drugs. The next slide shows you all the logos of the companies really most of this has been over the last 24 months that have now seize the technology and trying to utilize it to help both progress drug development and drug approvals, as well as better understand how biomarkers are affected by different drugs. And the FDA is actually issued guidance to support this and they are now supporting biomarkers as being a better way to get drugs approved into reverse symptoms in the area of Alzheimer's, you probably watch the Biogen announcement where they lost a lot of value several months ago when they said that the aducanumab beta amyloid anti-beta amyloid drug was being pulled because data was not sufficient. But when you look at a broader set of data included earlier disease and mild cognitive impairment you start to see that they are now very bullish on that opportunity. And so we think it further validates they're one of our largest customers. The importance of utilizing these technologies in the drug development processes. Next slide just illustrates that there's a lot of abundant markers that you may not need our technology for but by using our technology you can increase the overall quality and lessen the false pauses and false negatives. And you can also from a very small sample get an answer and then you can multiplex. And so our overall goal is to move from the left side of this, which is our research based over to the right side, where we are actually running this for trials to get drugs approved and then ultimately, we think there is a clinical opportunity where the dollars are largest. And so that's we're tapping on is going to be helping us as well as the different investments we're making around trying to get our biomarker starting with Nf-L clinically validated. The next slide just shows you how much excitement there is in the pharmaceutical industry for the Nf-L. There is 46 active clinical trials, and you can see that we're really honed in on three areas where Nf-L can play a role. It's primarily right now multiple sclerosis, but ultimately it's going to also be an TBI. There's two active trials right now where Nf-L are co-primary endpoints for drugs for concussion. And then also Alzheimer's. We think ultimately is going to be a interesting opportunity for neuronal health and the impact of Alzheimer's on neurons in the brain. The next slide just shows that there were several Phase III trials at ECTRIMS and the actual specifics of the drugs that we're utilizing Nf-L. The Slide 19 just isn't a repeat slide, it shows you that 100% of the publications that are done in blood are based on the Uman antibody pair that we now own and have just licensed to both Siemens and Techne. And in addition no, I'm sorry we license at the Siemens and we are supplying it to Techne and we did supply Siemens as well in Q3. But on the right side, you can see that we actually for several years look for antibody pairs to had the specificity of Uman and we could not find it. So we're really excited to leverage this around the world to help patients with mental conditions around the world with the technology and already talked about the Siemens, which is the next slide and that important announcement, but it is interesting to note that there is 1 million patients with MS just in the U.S. and there is a recommendation at someday they will be testing twice a year for Nf-L to determine whether the drug is working. So that's already just with MS could be a pretty formidable market and that's why the Siemens and others were teaming up with them with very attractive economics because of what we have is a proprietary antibody pair that proprietary pairs allowed us very attractive economics in a way we're navigating and negotiating these agreements and Siemens is an incredible positive partner. We're really excited about that build out. Next slide just shows someday, we think that there'll be routine testing done for looking for Alzheimer's long before dementia. You might have saw the game changing seminal trial that showed that they could see Nf-L elevation 16 years before dementia and Alzheimer patients. And so we're pretty excited how these types of early cohort biomarkers can play a role someday and not only screening, but then managing whether the drug is working. Now, if you really want to learn a lot about this. This next slide and my final slide is around the Powering Precision Health Summit and we are inviting investors. I already know several key investors that have decided to make the track over to Barcelona as well as some analysts. We had last year. I think 18 speakers. This year, we've got over 40 speakers. And we got two different concurrent tracks one on neurology and one on oncology. We expect almost three times the attendance that we had last year. So this is pretty formidable and a pretty exciting that we now have an advisory board for PPH made up of industry experts that are guiding the agenda. And you can see all the sponsors on the left that are making this free of charge for most of our attendees. So this is the way in which we create a lot of momentum very rapidly for the opportunity to utilize our technologies. So with that, I'd like to turn it over to Amol for a little bit deeper dive into the financials. Amol?