Kevin Hrusovsky
Analyst · BTIG
Thank you, very much Amol. I'd like to discuss today our Q1 highlights, our vision and strategy, both execution and the aspirational value creation. While navigating the COVID-19 is a big focus of our discussion today, we've defined in previous webcast call that we're going to continue focusing on neuro, plus in the near-term what we call the CAC pivot which stands for COVID, Accelerator in China pivot. And then we're going to further discuss just beyond COVID-19. Amol will provide a financial update and then I'll open it up for Q&A and then close the call. So on slide 4, it's a slide you've seen in the past. It shows our publications are continuing to evolve very rapidly. This is a very important part of our business and we're starting to see some acceleration in areas beyond just neuro and as we've put now with infectious disease. Biomarkers, we've added another eight to it so a total 330. You can see, we've had a very strong Q1 in this category of neuro as well as infectious disease and our Accelerator and we continue to do a lot of we'll call them drug trials and studies 116 total now. We've continued to place instruments. We're up to 429 installed base instruments and you could see our overall growth for Q1 despite COVID and some of the other issues confronting the world right now was plus 27%. And you'll see that that is actually 34% on an organic basis if you exclude the Uman acquisition. And 38% if you exclude the onetime large order we had last year for Novartis in the drug trial for MS. On slide 5, you'll see that our growth has been plus 27% -- 38% excluding that onetime. And we also feel that this is pretty important because we've been overhauling our installed base moving from HD-1 to HD-X. It's a pretty exciting event. The HD-X has more throughput, much highly reliable much more prepared for the clinic as well in a lot of clinical trials that are being run. And this is despite the COVID-19 impact, which was minimal in Q1 in our eyes really just part of the third month of the quarter was impaired primarily in North America. We also have seen some -- we took early steps to protect our employees and we have a resilience plan in place. We moved 100 people from in the facility to outside the facility. So, now we have 180 outside the facility, 100 remain in the facility. And we've had just really great performance over the last two quarters -- I mean two months. Sorry last month despite some of the concerns around COVID. We do not say enough about our team worldwide just stellar working around the clock 24/7. Once we had safety well in hand which we started early on, we repositioned to start allowing our exquisite sensitivity technologies helped with the COVID virus. And so a lot of our work over the last 1.5 months has been actually waking up the worldwide Powering Precision Health networks to the really remarkable data that's coming out around measuring the immune system response to the COVID virus as well as drugs to try to impair that response. Because in some cases, this response is so great that it leads to cytokine storm which leads to pneumonia and death. So it's pretty important to continue to monitor carefully the innate immune system as well as now you're going to learn we're moving into the system with our serology testing that we're planning to launch for research use only this quarter. Our Accelerator we continue to expand it and to allow customers to use it while they were down with their labs. And this is an important part of our growth in Q1 which we predicted would have already occurred just based on the HD-1 to HD-X crossover where many of our customers were already doing HD-X validation runs which prevents them from using the HD-X technology on the initial install. So, we already planned for that expansion. So it was great that we were there for our customers as some of those labs did close. And I think, throughout the industry we've heard numbers anywhere from 30% to 60% have closed their laboratories. Many times what we've seen is laboratories have shifted from running the trials that they have been running into COVID labs, so many oncology and neurology labs have been converted over into COVID labs. We have continued to engage our PPH collaborators worldwide and the publication flow is continuing, which is really good to see during these times. And we're really continuing to reinforce our utility in the Simoa technology and neurology. And you can see that, we had growth even in products, instruments and consumables. Particularly if you move to onetime our growth was about 17% in consumables despite this COVID activity in the HD-1 to HD-X crossover. But you can see that we nearly doubled our lab and other services revenue in the quarter. Now, in this past quarter, representing almost 37%. And gross margins continue to improve. If it weren't for the HD-1 to HD-X conversion, we would had another over 100 basis point expansion. Slide 6, just illustrates the demographics. I won't spend a lot of time on this slide. It's not as meaningful to look at growth percentages as the past given that. We're now dealing with the onetime effect of COVID. But you can see that, we do maintain about a 50-50 split between pharma, CROs and academia. And we are continuing to build out our Asia position, despite some of the issues that we're seeing. And neurology continues to dominate, our overall position, but we're continuing to expand that. So on slide 7, as we've shown in the past getting to answers that used to be late in the disease pathology and required invasive procedures like, operations for biopsies or cerebral spinal fluids, spinal taps to get answers we're really evolving that late and invasive testing to an early and noninvasive testing. And on slide 8, you can see on the left side there's probably 1,300 protein biomarkers in the RSU markets today and there's 205 that have crossed over into IVD with the high-content high-concentration proteins. But when you go below, what today's technologies can measure you can see there's almost a magnitude more proteins that we think are opportunities for further providing insights to clinical relevance, as we start to roll out our Simoa technology. Primarily, today we're only in RUO, but as we've pointed out we have aspirations to move it into the clinic. And on the right-hand side, you can see many of those very important biomarkers. Many of these actually are being measured for COVID. And these are many of the cytokines that turn into cytokine storm, and create the pneumonia and the lethal dimensions for COVID. And so that's why, it's critical to monitor these, and we're really excited that our technologies are getting deployed to support many of the COVID, ICU patients around the world in the hot zones. Slide 9 is a slide you've seen before. It shows the regulatory reimbursement risk on the left-hand side. We see this as being a much higher probability opportunity for drug companies to get drugs approved, because if you can attract earlier cohorts before symptoms of the diseases using biomarkers and engage the efficacy of the drug using biomarkers, you can actually achieve great efficacy with lower dosing. And that's what's enabled us to showcase much higher probability of an approval after Phase 1 approval biomarkers are used. And that has led to many multiple growth catalysts, and allowed us to go from basically no revenue to $57 million in 2019. As you can see in Q1, we're continuing that growth. We are doing some level of expansion of our overall market opportunity into infectious disease. We were there once with HIV very successfully with p24. But now, we're reentering it, because this is now a structural change globally that, we think infectious disease will be a core research category for the next five years globally. So our PPH ecosystem is well engaged and we're now migrating into a lot of studies and a lot of work that will lead to publications in this landscape. I think one just came out already this quarter or this month for COVID, which is pretty exciting. And we're starting to see Accelerator projects looking at COVID cohorts as well, which is also very exciting. Again, it still stays low regulatory. I think we do with RUO and we do think we have a very strong economic profile and we're very early in the penetration. We do have a very proven management and founder in David Walt who himself has done a lot of great work over the last two months in the area of serology showcasing our technology across all three of the immunoglobulins, IgG, IgM and IgA as well as across four different antigens. Some pretty compelling data is being shown on high fidelity and even quantitative technology for IgG. And on the right-hand side, this is what we said at the beginning of the year. We would start working towards the aspiration of moving across. We said in neurology first. But we're now starting to see some very interesting opportunities, even in the serology landscape that we're at least exploring as we move from CDx companion diagnostics into LDT. And then ultimately, we felt it would take several years to get into IgG probably through partnerships, but with the current serology landscape being that it is we're going to continue to explore, if there might be possibilities for us to enter into that landscape as well. So, we do think our blood test being so precise high fidelity with great sensitivity opens up a lot of high-value creation optionality. And again, we've added COVID-19 now to that optionality. And we are looking at rolling out a high fidelity serology test in RUO on the left-hand side. So we will consider, if that would make sense some data evolve into actual clinical markets for serology from an IVD basis. We do continue to see high potential IVD partnerships and we're going to continue exploring those. And some of the companies that already do own our technology and doing a lot of work with us are shown below. On slide 10, our focus on the left side as we've talked in execution mode it's primarily in neurology that light blue area. But we started to evolve into oncology and our plan was to use the HD-X and SP-X where we're less than 1% penetrated. But many of the larger competitors Luminex, MSD, biotech in that landscape of oncology we're still less than 10% penetrated in neurology. So we were going to expand into oncology, but we've found a lot of those assets and those products are quite adaptable to the COVID-19 pandemic. And so now we've redeployed many of our oncology assets and many of those labs have become COVID-19 labs anyway. So it's almost an earlier entry way for us to teach the world about the attributes of exquisite sensitivity and how that can be redeployed to create reductions in false positives and false negatives. And in the area of serology, we know that's very important and across almost every test in COVID-19, it's important to minimize the false positives and negatives. So on the right-hand side, we still have those aspirations but we are exploring HD-X as well as the SP-X in the landscape of infectious disease now as well as the continued evolution of HD-X and SR-X for neurofilament light for MS particularly on the right-hand side. So slide 11, just shows the three pronged attack that we mentioned in our pivot, and we're looking now to be able to measure, both the innate and the adaptive immune systems with our RUO product line hoping to launch, the adaptive immune serology tests sometime in Q2. And this is helping companies with drug targets and trying to get drugs effective for COVID-19, and as well as trying to predict cytokine storm before it's lethal and try to intervene with immune modulation drugs. And so we also see vaccine development be an important area for our technologies. And we'll continue to evolve them for drugs vaccines and the convalescence plasma treatments. The Accelerator services is also a very strong opportunity for us, during these times of interruptions. We think this full year, we'll have a very strong opportunity. We're even seeing interest now in serology and population studies for COVID population around who has actually caught the COVID and has immunity built either innate or adaptive. And how can they start to figure out ways to get the population of the world back to work. We think this will be a pretty important area of RUO research use only for Accelerator. And we also believe China is coming back on the market sooner and we wanted to catch that wave so we've accelerated our build out of China. You can see on the slide 12, all the different collaborators around the world in our PPH network that are really helping enable a very rapid commercialization of the technologies we roll out from a PP -- from a we'll call it, an RUO basis. There's a large installed base a lot of sample sets and banks around the world in all the hot zones. We've been having webinars with those live that investors can actually tap into. If you want to listen to the one, we had three weeks ago that's accessible and it was pretty compelling. And we'll probably have another one in the next several weeks, as we roll out the plan for serology RUO test kits. So on slide 13, you can see we've already been an innate, number one, based on what we were doing for oncology cytokine storm interferon and pro-inflammatory markers. Then on the right-hand side is, where we're moving next with our RUO franchise moving into this area of immune response adaptively. There are some EUAs in this landscape. We're only exploring it at this point, but we do think passport immunity is going to be important, as well as disease severity vaccines and drug development as well as, as we mentioned convalescent serum in that antibody production area. This slide 14, just further showcases all of the panels that we have established in the different product lines for measuring the innate immune system and the cytokine storm both for predictive and drug interactions. Slide 15 just describes some of the key componentry of what we're working on right now for our COVID-19 serology panel. Starting with IgG quantitative test, we'd like to launch that in Q2 into the RUO markets and have some Q3 volume from it. We see it being very high sensitivity and specificity, reducing false positives and negatives. And we can see these immune much earlier even potentially providing orthogonal opportunities in blood for infection determination almost potentially as early as the infection itself. And we know today that there's a lot of false positives in the serology landscape. We also know there's a lot of false negatives in the viral detection landscape. It's hard to get many of these viruses onto nasal swabs, and as a result as much as 30% could be missed. So having early understanding of the immunity build is a great orthogonal way to go after some of these tests. Our technology does -- the HD-X can right measure as many as 1,000 tests per day per instrument if in fact utilized around the clock. And as you know we've got over 250 HD-1s and HD-Xs around the world. Our initial rollout would be probably on something that would deploy the HD-X further, enhancing HD-X value to our customers, and hopefully still helping accelerate HD-1 to HD-X opportunity. Sample banks, as we mentioned around the world, and we hope to launch in Q2 an IgG quantitative RUO test. The next several slides just talk about number two the adaptive. You can see on the right-hand side there's a lot of IgG and IgM, there's a lot of historic viruses that are tricking a lot of today's serology tests. They measure a lot of those historic viruses, creating a lot of false positives, which could lead to someone thinking they have immunity when they don't, and that's an important trait. So by having this exquisite sensitivity, we can dilute these samples a thousand-fold, and we can look at as you can see in these next several slides different curves of the IgG particularly is what we're interested in, and we see it earlier with quantitation. So we think that the ultra sensitive is key for eliminate false negatives even from the viral detection. And so in summary on slide 20, we see the ultra specific, sensitive and quantitative RUO test being highly productive and we want to utilize and roll that out to try to help the world. And top right corner is our sensitivity. We also are going to explore getting the answer from finger pricks and drawing blood products and then potentially saliva at some point, because of its exquisite sensitivity and the need to dilute anyway to eliminate matrix effects. So on slide 21, this is a similar commercial group. We've already had 42 meetings in the month of April with the PPH network did that webinar and we were trying to build some momentum for Q3 and Q4 to drive at this. We know Q2 is probably gets some headwinds obviously from COVID, but our intent would be by end of Q2 to roll out some really nice product offerings for COVID and infectious disease for the second half of the year. Accelerator you can see we already are starting to see trials, I think one has already been signed up for COVID, which is important for and that one is for innate immunity where we can look at all these different cytokines to see how a drug is interacting with it modulating appropriately. And we're also linking our commercial organization together Accelerator and product sales together to further enhance the ability to move companies that have our technology that might be shut down into the Accelerator to continue running retrospective trials particularly in neuro. And in China, we're continuing to try to build out that footprint, and we hope by the end of the year to actually an Accelerator position in China to help further help demonstrate our ability. Slide 22 just shows the various products that we sell. Once again, there's two bead based HD-X and SR-X. And then the planar based, which is a high cytokine panel 10-plex that's been used in oncology, but now we're evolving into COVID. It's the SP-X. And then you can see the kits that we sell and the services that we provide. Slide 23 is a repeat slide from the past. It just shows that if you can use our technology and increase the probability of the drug being approved by 300% after a Phase 1 approval, it really creates a lot of momentum for drug companies to want to utilize it. And that's where all of our -- a lot of our growth has come from the last three years: by further modulating down toxicity, and modulating up efficacy by seeing these earlier cohorts. And you could see the number of CROs that now deployed it, which is also important if we're going to be looking at serology tests. We like to engage our LabCorp and Quest and others that are very strong partners rules-based medicine. Frankly there's other places have CRO capability. If we roll out serology RUO tests, we'd like to be able to run those in those facilities for many of our pharma customers that are trying to interact with drugs and vaccines with those technologies, and we ourselves now have 116 projects Phase 1, 2 3 in our own Accelerator lab. And the FDA continues to explore even neuro and COVID believe it or not, there's a lot of examples, where there's loss of smell, loss of taste, those are CNS functionality. So we have a lot of customers now starting to run Nf-L, even looking at COVID implications of neuronal death and neuronal damage, which we think is just another way to showcase our technologies. Slide 25 just shows all the companies either in research institutions, pharmaceuticals, biotechnologies, and CROs, and others that now are deploying our technology further building a strong installed base and validation for what this technology can do. Slide 26 is now just saying post-COVID, we are still very focused on MS trials. There's several drugs that we know have already utilized our technology in Phase 3 trials of secondary surrogate endpoints. There's just a very strong avalanche of publications. We would like to think that there's an opportunity to get MS as a disease-progression opportunity for Nf-L. And the FDA we'd like to have a meeting with them this year. Originally, we wanted it to be in the first half, but at least this year, now with some of the delays due to COVID to talk about getting Nf-L approved as the disease progression monitoring technology for Nf-L -- sorry, for MS which is all that evidence. And this slide just shows the way our commercial organization starts to look at total clinical trials using Nf-L which ones are actively using it and how we can start to then go and find companies where there are Nf-L opportunities where drugs are trying to be approved, but aren't currently using our Nf-L. And so we're -- you can see we still feel we have a very low penetration. So, our salesforce is becoming more educated each quarter as we use these kind of tools to point out where there's opportunities for neuronal pipelines that can benefit from using Nf-L to get approvals. This slide 28, it then shows that Novartis and they have a drug that they're hoping to show approval for in June that used one of our technologies as a secondary surrogate end point in the Phase 3 trial. Roche and others have used it as well in key trials Biogen. So, we're continuing to just evolve this. We think someday everyone should know their Nf-L level. And the difference between dying, standing up versus being in a wheelchair could be by measuring Nf-L because it will allow patients to get on the right drug sooner versus waiting as long as two, two and a half years with today's MRI to figure out whether a drug is working. Testing Nf-L non-invasive in blood we think within three months, there's evidence and some publications can tell you whether the drug is stopping and slowing down and reducing neuronal death via our Nf-L test. This is pretty compelling data. And this is the two big trials that we talked about previously. On the left is an analytical validity 17 different sites around the world. It's getting the same results with our Nf-L which we think proves an analytical validity. And then there's a major trial normative study currently going on in Switzerland, which attempts to show healthy patients what the average Nf-L level should be at different age groups from age seven to 70 if you're healthy. So, anything above that would suggest that there's some neuronal damage occurring from some neurodegeneration of some disease whether it be Alzheimer's or MS Parkinson's or concussions or other physical damage to the brain and we think that's going to further support our clinical validity claims. So, we wanted to update the slide given -- in COVID we still see strong utilization potential for our technology. But we think it's going to be more like 40% for the full year as well as HD-Xs by year end, we think we can get 40% installed still which is still a pretty remarkable move. We're continuing to develop the high-resolution COVID-19 immune response. And we see the potential for $3 million to $5 million of revenue this year from the JOLT that we're putting into the pivot into infectious disease. We can't say for sure, but that second half we think does have real potential for that infectious disease opportunity. From a strategic standpoint, the IVD partnership is still something we're focused on. Our plan to continue to look forward also opportunistic M&A. We have a strong balance sheet. We know that this industry has gone through a lot of trauma right now. And so we want to be there to support any -- what we'll call opportunistic ways to accelerate our strategy perpetration. You can see our goals for gross margin. For the moment, taking that off the line just based on the total revenue that we're trying to sort out for the full year, but we still think we can have 75 HD-Xs in place by year end and 75 SR-Xs and SP-Xs. And we still continue to look for 100x sensitivity increase seeing great work in our pilots right now continue to advance our R&D investments and not slashing a lot of headcount for the moment. We feel like this is we've got a very strong offensive opportunity to grow our company into the second half and we don't want to in any way damage our long-term growth opportunity that we think is remains probably more bullish now than ever before. And now we're having a chance to even showcase faster we think the technology in COVID. So, Amol, I'd like to stop there and turn this slide over to you.