Kevin Hrusovsky
Analyst · Canaccord Genuity. Your line is open
Thank you very much Mike, and hey, welcome on board. It's Mike's first call with me. Very excited to have Mike Doyle with us as our new CFO. Hey today, we're going to go through three major agenda items. First, the major advances that we had in Q2 and really the first half of this year that's accelerating our growth as well as enabling a new term not just therapeutic drug discovery and development, but diagnostic therapeutics, which we think is a new category that's pretty exciting for neuro. Mike will then talk us through the financial results, and I will then end up with the objectives. And we'll open up for questions and answers. So I'd like to just start on slide 4 with some press that you're starting to see out there. This is what we've been describing for really the last six, seven years and it's been a big component of our Powering Precision Health ecosystem and foundation. It's about blood-based biomarkers, fast becoming the gold standard, surrogates for traditional tau and Abeta PET imaging. So transforming drug discovery in neuro primarily from spinal taps and imaging into blood-based is a key opportunity area that we're very focused on and making a lot of progress within. And the other quote here coming from Fierce Biotech, Lilly adds on to biomarker bombardment in Alzheimer's with two new donanemab analyses. And really ever since the FDA approved Biogen and Eisai's Alzheimer's disease treatment Aduhelm, the buzzword among competing companies has become the biomarker. And that's just what Eli Lilly has to offer with two new analyses on their candidate donanemab and we will describe in more detail these opportunities. So let me now turn to slide 5 where we really have some pretty important news to convey. We did have record growth, record adoption, and we continue to evolve what we would consider to be the momentum for plasma biomarkers. And surprisingly many of us were very much excited to learn that there was a new Alzheimer's disease-modulating therapy approved. And what's also interesting is we launched pTau-181 and also a NeuroPlex, which has had very strong growth and it's continuing to accelerate. We consider it to be an important catalyst. You may have also read from Lilly and also heard from their presentation last week at AAIC that Simoa plasma pTau-217 correlates with donanemab efficacy reported by Lilly. And interestingly our Nf-L, which we at one time called an engine-check light on the brain and we do think someday everyone should know their Nf-L number in case they ever come in harm's way with neuro degeneration or concussions. There's a lot of momentum continuing to advance the breadth of that biomarker as well. From the business update, standpoint strategy updates, payer adoption continues to be an area that we focus on because in the end getting these drugs paid for and approved we think diagnostics can play an important role there for monitoring, drug performance and making sure there's real coverage with evidence. We also -- as you know, there was some of our technology air freighted down to Bethesda, Maryland to Anthony Fauci's labs. And in those labs, they're looking at using our test, measuring the antigen for new drugs and current drugs to better arrest the COVID virus. And there's also a lot of long haulers that are continuing to be plagued with symptoms and those who have lost taste and smell and have brain fog, there's been a lot of publications now linking -- using our Nf-L Neurofilament Light showing neuronal death. And there's growing concern there could be linkages a lot of publications recently published between COVID and early Alzheimer's. So that's further fueling both of those categories. We all saw almost 50% of our HD fleet because of a lot of sales is HD-X primarily linked to Alzheimer's and this revitalized landscape for Alzheimer's trials and growth. We also -- as I mentioned Mike joined us; but so has Masoud Toloue who joined us from PerkinElmer running our Quanterix diagnostics division. Plus he's our overall President of Quanterix. We have nearly $0.5 billion of cash on our balance sheet, which we were successful in raising a couple of times in the last year, both of them were up rounds. I mentioned that we had a lot of advances in Nf-L, but just in general we had record publications on our biomarkers and our disruptive technologies and new biomarkers. We also hired Will Geist to further advance and accelerate the scaling of our company to catch up to the demand that we're creating and that has been going very well. He and his team -- he's recruited a lot of top guns into our company to help us scale and catch up to the demand. We do have some stock-outs just stemming from the increased demand that none of us probably expected this level of Alzheimer's enthusiasm, and that's continuing to create a lot of opportunity for us in the future. So our timing of bringing Will and his team in was really quite good now that we look back given this advance in the Alzheimer landscape. We also are expanding our laboratory. Masoud has taken over control of the Accelerator lab helping us to further expand that, because we do see linkages ultimately to diagnostics. And we are continuing to progress our 100x -- or have had success on 100x increase in sensitivity, which will allow us to see disease even earlier even sooner than we can today with many of the biomarkers and enable certain biomarkers that we can't even see today in the noninvasive samples like blood or saliva or breath condensate or nasal swabs. On slide 6, we just wanted to let you know, we had a pretty strong Q2. We had 86%, we'll call it, non-GAAP growth. The actual GAAP growth was 93%. We took a little bit of the revenue out of that, because that was a one-time event with the NIH around bringing our COVID solutions to the market. We now have two EUAs: one for serology semi-quantitation working for advancing that with the Delta virus as well working towards a label claim for it; and also the antigen test. And that is a growth -- primarily a lot of that was due to Q2 last year being pretty flat with the previous year, maybe even a little bit lower. But, still when you look at our CAGRs, you can see that we're staying within the 30% to 40%. From the 2019 base year, we're still advancing very productively. And we continue to derisk that with all this new momentum in neuro. And on the right-hand side, you can see that our strength here was in fact instruments. I do believe, while Lilly purchased five HD-Xs in Q2, just as an example of that scaling up that they're planning for a lot of what they've got coming in their neuro franchise as well as their Alzheimer's franchise. And consumables fulfilling a lot of these trials is also up. We expected lab/services to be flat at best and that's even more true now that many of our customers are buying new HD-Xs and trying to run their trials out in pharma. And so we know that for the next year or so, we're going to have just a lot of stronger growth probably in consumables than we've had historically. And some of that maybe at the expense of our Accelerator, which doubled in growth last year, because many of those labs from -- that were shut down for COVID utilized us, giving us a lot of growth last year. So, we'll be able to at least achieve last year's level and maybe even beyond that, but the consumables will be the big story here. And you can see that our overall growth really also helped us with our gross margins on a non-GAAP adjusted basis, which again taking out the RADx revenue were up 1,100 bps which is a very significant advance. This next slide just shows you the same exact approach just looking at first half. And our overall non-GAAP growth, which was slower than GAAP growth, because we removed the RADx was 71% for the first half. And on the right-hand side, you can see a very similar story. We're pretty flat in Accelerator, but triple-digit growth in the consumables and instruments and very strong CAGRs on those categories. This just shows you on slide 8 the distribution, and you can see we continue to evolve our position in Europe and Asia. We also are seeing a 50-50 between academia, where a lot of publications are coming from that fuel then ultimately pharma and CROs with a lot of those new biomarkers. And neurology is now 80% of our focus and our achievement and you can see the consumables now represent almost half of our company. Slide 9 is key, because it's the fuel of our business and the publications continue to roll in. We're now up to nearly 1,400 third party peer-reviewed publications validating across 432 different biomarkers. And our instrument placements, you can see we're now up to 621 worldwide and we continue to run trials inside the Accelerator Phase 1, 2, 3 trials. There's been over 1,000 Phase 1, 2, 3 trials run and that's the fastest adoption cycle we've ever seen in pharma/biotech over the last five years. Further testament to how these biomarkers allowing you to see disease non-invasively before symptoms is a transformative value proposition and strategic approach for pharma. This next slide just summarizes that -- we've been saying that we've got both execution and an aspiration. The execution is primarily around research and development where we don't see regulatory or reimbursement risk. And you can see, now we've got three major growth catalysts: this phosphorylated taus that we mentioned; the neuroplexes where we combine multiple biomarkers for Alzheimer's as well as many of the other neurodegenerative diseases; and this new term that we're coining today the diagnostic therapies. We believe that by deploying therapies before symptoms, you're actually bringing a level of value that we think is unprecedented for patient treatments and outcomes. And in a way we think this actually brings a lot more value to diagnostics than we've ever seen before as it plays a role now -- a complementary role with the therapy. And revitalizing this whole Alzheimer landscape is what happens when COVID starts to trigger the concern around early Alzheimer's as well as having a drug actually get its first approval, stimulated a lot of excitement. And then, you can see our third growth catalyst is the ability to catch up to the demand by just expanding the capacity with our scaling of Quanterix with that program we mentioned. The HD-X is having high throughput 1,000 data points a day fully automated, and then expanding our laboratory longer term looking towards diagnostics and then bringing on the 100x. Then on the right-hand side, where -- we know we've unlocked a much bigger TAM by cutting across into the diagnostic landscape and the $20 million, we got from NIH for COVID, bringing two EUAs emergency use authorization diagnostics to the market allowed us to build our infrastructure and to attract people like Masoud. And we've even got Dawn Mattoon now who had been running a lot of the research side of the business. She is now with Mark Roskey, both of them working with the strategic accounts across both research and diagnostics. And so, we're building out this right-hand side and it's been accelerated, because of the bridge that was built from COVID from the left. And so we do think that as we continue to build there's some long-term very interesting catalysts around Alzheimer, health screens, diagnostics and monitoring whether these Alzheimer, diagnostic, therapies are in fact bringing down plaque levels and bringing clinical benefit. And the recent data from Lilly says, bringing down plaque as evidenced by measuring our pTaus is also correlated to clinical benefit and that's a pretty important breakthrough that we're all striving to achieve for helping Alzheimer's patients. We're also, as we mentioned, increasing our Accelerator footprint for LDT and working hard with the payers to understand these health screens. And UnitedHealth Group now has our technology in their R&D labs. We think this is an important testament to the advances. So historically, we've shown this next couple of slides where by just bringing sensitivity to protein measurements – where there has been about 200 IVD proteins being measured by primarily Abbott Siemens and Roche collecting $25 billion of revenue on diagnostics of proteins that pretty much are measuring disease after symptoms. Our key is by going down in sensitivity on slide 11, seeing it noninvasive and before symptoms and we think there's 1,000 proteins of reach. And this translation going from research on the left to diagnostic's on the right, more like taking analog phone of the yesteryear and moving it into the iPhone today, which we're actually recording this conference on. This next slide just shows you on the right-hand side that, there's about $100 billion to $110 billion of value in revenue and TAM that we think by seeing disease before symptoms you increase the size of these markets. Even for Alzheimer's, if you look at Alzheimer's being defined at the moment you start having severe dementia and – but if you can see it five years before, and as you know several researchers and third-party peer-viewed publications have shown that you can see Alzheimer's as much as 15 years before dementia using, our biomarkers in non-invasive blood, we can significantly expand the size of that market by not only treating patients that haven't presented yet with dementia, but also increasing your chances that you're going to be able to arrest that disease progression by getting to the disease when it's still much more treatable. And that's the new mantra that this slide 14 has always tried to showcase and that is that many neuro patients don't even know they've got neurodegeneration until they see the symptoms of dementia. And you can see in this click 15, three slides coming from Lilly, where you can actually see the tau and the amyloid plaques growing. And many times the amyloid plaque is there before dementia and that's what they call the Goldilocks location. They're trying to find patients that have the amyloid beta, but before they have mild cognitive impairment or when they only have mild cognitive impairment. And then slide 16 is our goal to go with our new detection sensitivity to move this into monitoring patients, so you can see the beginnings of Alzheimer's and then treat very early. This next slide is a new slide that, I think is trying to establish a new category. On the left-hand side, you see there's been over the years much investment in protein and antibody discovery, and it's the pharmas and the diagnostic companies that are the best in the world at doing that. They feed their learnings into two primary categories. One of them is the diagnostics industry and the other one is the drug industry. And in the center here, I'm showing the brain with all these biomarkers now that we have in our menu that are basically proteins that are being released from the brain and you can see them non-invasively in blood with our technology. And it's interesting that Roche is the one pharma that has a diagnostics position. And interesting also, is Lilly has some really strong diagnostics capabilities that we've been able to team up with over the last five years, which makes them pretty impressive to work with on this new category that we're in coining the neuro diagnostic therapies. And going for coverage with evidence and getting better outcomes more efficiently is, what we think can happen when you start to commercialize these drugs and deploy them before symptoms. This next slide is the overall engine that we've used to build our company. We start with a biomarker being discovered by a researcher and then pharmas adopted based on that research and those third-party peer-reviewed publications. Or they may come to Powering Precision Health Summit learn about it then they start to apply it. That's the first phase of adoption. And that's where you saw on the front page of New York Times and USA TODAY, the ability to see Alzheimer's 16 years before symptoms using Nf-L and also pTaus through 17. And then it moves into step two, which is demonstrated clinically with high validity and utility. And that's the phase we're in right now around these phosphorylated taus, linking it as you've seen evidence from Lilly to specific disease pathology that can actually also be linked to the clinical benefit through cognitive impairment scores. And historically, they've used CSF spinal taps cerebrospinal fluids spinal taps; or PET scan to get that data. And this is – our disruption is this incredible correlation and seen in a very low-cost noninvasive blood test even earlier than what you can see in many of these more invasive techniques. And so while you move from that number two category to actually then evolve it into a diagnostic and a health screen that TAM goes from $0.5 billion back in the research level to 20 times that, so $11 billion once it becomes a true diagnostic. And by – all along you're increasing the odds of that drug getting approval by 300% based on pharma's own data. So that's why we think we've got an engine here of value creation that is unprecedented. This next slide says that – it's a jigsaw puzzle of connecting the pharmas with the payers with the FDA NIH where we've had a lot of advances, because of the money that NIH gave us in the RADx program with COVID. That infrastructure and then learning about Simoa and Quanterix has been key. We've got all these CROs and pharma partners too down in the bottom right corner Quanterix does. And we've seen major progress in every one of these puzzle pieces over the last 8 months to 9 months. And that's creating the opportunity we think for disrupting this whole approach of bringing a diagnostic into a therapeutic realm of benefit by moving these therapies earlier and allowing that with disruptive technology in 100x. We like to form partnerships now with pharma with our Accelerator lab looking for biomarkers using our 100x, using our antibody and our assay capabilities with these KOLs around the world, and tapping into the samples from pharma to let them advance in every disease category. So it's not limited to neuro, but our initial focus and priorities are around neuro. I did want to point out that, there's a lot of evolution that's occurred with ADUHELM and a lot of controversy on whether reducing plaque is ultimately going to lead to a new drug. There are some great history I'm looking at HIV, where biomarkers got started as maybe cell counts and then they move them into viral loads. And once those biomarkers got established it led to some pretty significant advances, going from CD4 cell count to viral load. You end up 20 years later with 29 therapies, and we really now see HIV being somewhat chronic. Well, I'd like to draw the parallel to the cholesterol market for the brain – or for the heart, where there's still a lot of questions regarding the long-term qualitive linkage between cholesterol management and heart health and life expectancy, but yet there's a $1 trillion patent market. In the cancer world, there's a lot of evidence through accelerated drug approvals you can reduce the size of the tumor but it doesn't necessarily mean you're going to live longer. But yet these are ways to get the drug industry going down these paths. And I think in the top right corner you're starting to see that in this landscape of Alzheimer's where there hasn't been any drug-modulating therapies approved. We're getting it started now with some biomarkers that might be game-changing and make them less invasive with our technology. I don't want to forget though that Nf-L continues to be I think a long-term incredible opportunity. And there were some publications that came out this quarter looking across 40 different sites 13 different neurodegenerative types of diseases ranging from Parkinson's ADS – ALS, Down's, psychiatric disorders, frontotemporal dementia. All of these showed that the Nf-L level is elevated as the disease progressed. And we even found evidence that it elevates faster if there's psychological issues with the disease neurodegeneration. So these correlations are beginning to build a body of evidence around Nf-L that makes it a really long-term, we think check-the-engine light for your brain health for -- that everyone should someday know their Nf-L level. This next slide shows now there's three drugs that use Nf-L -- our Nf-L to get themselves approved as a secondary or primary endpoint. And this is important because we also think if you can see in blood very rapidly MS disease progression you can actually use it to get patients on the right drug sooner and allow them to get the benefit of the drug quicker. And this Slide 24 just shows that we bought the Uman company, where we have just about every publication either in our Simoa and/or that antibody pair from Uman, which I think has led to a lot of advantage for us. Overall, this slide just illustrates on 25 that there's a lot of neurodegenerative diseases. If you just look at the point when you have symptoms there's 6 million patients worldwide. But if you again can move it forward 5 years that could double. And our last slide here, around these biomarkers just show how we're populating in blood these various biomarkers for these different diseases, allowing us to become the neurodegeneration leader and trying to help pharma bring them to bear. And I'll close by just saying that the phosphorylated tau-217 remains in our minds really interesting. We launched the 181 and there's now evidence that you can even see the disease sooner with the 217 with greater dynamic range, which makes it even a better possibility for becoming a diagnostic. With that Mike, I would like to turn it over to you for some financial summary and then will come back to close it off with our strategic objectives.