Kevin Hrusovsky
Analyst · Sung Ji Nam with BTIG
Thanks, Joe, really appreciate. We really feel good about the fourth quarter of 2018 and also the overall progress made throughout the year. In the same framework that we've used in the past, I'm going to go through a series of slides that are online and on our website. I'm going to start with the agenda where I'm going to talk through the Q4 results and the 2018 highlights, but also going to lay out the 2019 goals and priorities. And then finally, we've made so much progress in the last few months in the area of neurology and the momentum is just continuing to build. I would like to take a few moments to give you some updates that I think are fairly material. Joe will then provide some commentary around the financial reports and then we will go into Q&A. So starting with a slide that basically says, we've defined a technology that's got exquisite sensitivity on measuring protein biomarkers and blood and that sensitivity is approximately 1000 fold greater than the traditional ELISA technology that already was more sensitive than many other technologies. We've been around really since around 2013 with the technology being launched. And you can see that back about four years ago, we decided to go after research first where there's no regulatory reimbursement risk. And we really went from no revenue to 38 million this past year. So that's a very rapid ramp. And about 40% of that is consumables, which is also a very high level of visibility with those types of businesses, which is -- also generates most of our margins as well. So we're pretty excited about just the ramp that we're having at the consumables of this business, but longer term, we are going to go back into diagnostics. And we do believe that the opportunity in diagnostics is about 10 times the size of research. So we wanted to get the order, right and we wanted to minimize risks for investors. And so we think we've stepped up -- we're stepping through that as planned. We felt our execution was absolutely superb in ‘18. We actually started the year by acquiring Aushon for immaterial levels of money. I think we paid 4 million for a technology that probably had over 30 million of investment had gone into it. And then in September, we actually regained all of the bioMérieux exclusive rights that we had licensed to them. We were able to get those back into our company. This was a fairly significant moment for us that immediately caused our attention towards attracting some of the best talents that next to me is Jackson Streeter who's a neurosurgeon who was actually CEO of Banyan for many years and he got the first two biomarkers and blood for concussions approved by the FDA back in April. I think it was an accelerated approval, only took four months. So we're really excited, he left there to join us as well as we got Mary Ellen Cortizas who actually ran a lot of the LDP labs coming out children's hospitals. And so we're continuing to bring in some of the top talent in the landscape of what we're going to be doing with our biomarkers. We also 2018 had two FDA meetings, where we actually presented on the neuro-filament light biomarker, which has really become over 10% of our revenue when you consider not just the sales of the NFL assay, but also the services that we're providing for NFL. It's a way to look in blood for neuro-degeneration and looking at when the neurons break down across almost every disease state as well as physical injury like from concussions, so pretty excited. Could this become the cholesterol of the brain as an example, we're pretty excited that this has shown a lot of promise and the FDA was [indiscernible]. And then we did launch another product in 2018, which is part of why for the first time we're seeing significant instrument growth. It's been three years, we were pretty flat. In the second half of this past year, we've had really strong instrument growth. And we also are launching in the second quarter a product for cancer called SP-X. And we had a really awesome participation in the Powering Precision Health Summit over in Amsterdam in December. So on the right hand side, you can see the growth has been continuing to step up. And we -- this is the fourth quarter really of us being a public company of reporting. And the first quarter we reported was flat. Then, we went up 41% in Q1, 66% in Q2, 61% if you eliminate the one time and then this quarter Q4, we’re showing 65% growth. And we really want to thank the investors who have played a pretty big role through and helping us position our technologies of pharmas and biotechs, that they also own and benefit from our technologies and helping get drugs approved. So it's a pretty important piece of our overall evolution. The next slide breaks down the growth that we had, and looks at first Q4 and you can see that we had 100% growth in our instruments. This is really the result of the SR-X launch and a lot of the work that we've been doing towards bringing instruments to bear that are much more user friendly and democratizing this overall -- and scaling this overall technology out into the marketplace. Obviously, we're not going to continue seeing that. That's the surge of new products. And at first half of the new product launch, which really was the second half of 2018. So we did have also nice margin movement. We ended up with 4 gross margin points of improvement, 400 basis points of improvement, which if you remove the one time, it was probably a little over 2.5 or 250 basis points, but still very nice movement, a lot of it through the mix and improving the consumable portion. And then when you look at the full year, 60% growth, you can see that once again, when you average the growth in instruments, we still end up, for the full year of having 45% growth and you can see that our consumables were at 83% and the utility across the instruments is also pretty attractive. We were able to get to 40% of our list price and consumption per instrument, which is a pretty high hurdle that we were able to achieve. And it takes us normally six months, we believe to get to a third of the revenue, but we are -- we actually outpaced that and a lot of it's because there's so much attraction to seeing biomarkers in blood and that's a key for our future growth as well as having that strong installed base. The next slide is what we've laid out as being our strategic roadmap. Slide 6, where we really work on publications being the leading indicator when third parties peer-review based on some study, it can have a profound effect on researchers around the world then, reading that study and then wanting to get the technology or applying the technology. And you can see that there's a really rapid ramp of up to 409 third-party peer reviewed publications now, most of those or half of those are in action in neurology. And then that leads to the number of biomarkers and blood in the menu expansion. And we're now up to 259 markers, have been run in our technology. And you can see the accelerators were our services business. We continue to grow that and do a lot of studies for customers. And we now have run 45 drug trials, phase 1, phase 2, phase 3 in our labs, which when we acquired Aushon, it gave us a clear lab and that's allowed us to further expand our capability. And then you can see the instrument installed base continuing to rise pretty quickly and you can see the overall growth that we talked about. And then on the right hand side, you can see the consumables, which has been a very steady growth and we're pretty excited the way that has been growing and really above 50% growth. Next slide just shows our overall demographics of the company right now, we're still running about 60% United States and we're just beginning to move into Asia, while distributors at this point, we see that being a stronger part of our growth in 2019. And most of our customers still are pharma, biotech, but we're getting a little bit better balance now of academia. We think 50-50 is where we'll probably end up as time goes on. And you can also see that our growth over neurology and oncology, which is our primary focus, because that's where you see disease, the latest stage, we just heard about Alex Trebek getting pancreatic cancer, stage 4. It's very hard when you get some of these cancers early. And so, it's already talked about blood testing for pancreatic cancer, et cetera. But the key here is when you can see disease earlier, it really can have a big effect in oncology and neurology. And we're starting out in neurology. The next slide 8 was what we walked into 2018 with was all the strategic priorities that we laid out and the goals and then everyone of the categories, financials, commercial, strategy and new products, we were able to overachieve. So we actually feel very confident that we were able to lay the foundation for 2019 and beyond by overachieving and getting the FDA rights back, the IBD rights was a major achievement that really took four years and we're still very friendly with bioMérieux and they still utilize the technology. It’s just that they're more infectious disease versus the oncology and the neurology that is the focus of our technology. Slide 9 lays out and you may have seen this in the JP Morgan presentation and the Leerink last week, lays out our goals for 2019 and we're going to continue growing the franchise and neurology where we still believe we’re less than 10% penetrated. We're going to continue increasing the menu in the second half of this year. We're going to roll out an advancement to the HD1, which we're going to -- we call the HD-X, we're expecting in Q4, we will see that launch as a way to migrate customers to some new features that will allow a little bit greater sensitivity, temperature control as well as what we consider better beat loading. And that enables better efficiencies of the technology. We're going to continue scaling the company around the world, putting a lot into IT. And facilities, we’re moving into a new facility in the middle of May. And our headcount, half of will go to commercial where we continue to grow very rapidly. The second major categories oncology and that's that SP-X comes right out of the Aushon acquisition allows us to multiplex and move into cancer, which we think is three times the size in neurology. So we’ve just done that and we hope that by the end of the second quarter that will all be launched and will be off and running. And then the third category is entering diagnostics. We want to continue these drug trials and we expect that we’ll have at least 50 trials this coming year in neuro and oncology and we want to land an LDT relationship. All of the major reference labs right now are working with this. They all have our instruments and they would like to migrate from just CRO services, contract research for pharma into actual LDT testing. And many of the neuro drugs that are being approved are looking at disease progression markers like neuro-filament light as a way to monitor whether the drug is having a desired effect. And ultimately, for Alzheimer's, we like to have a blood test that could actually move patients into the Alzheimer drug and that's a new field of opportunity that we'll talk about in the moment. And then in financials, we've kind of gone through those already. But across the board, we feel that we want to continue evolving our gross margins and maintain our utilization and we do believe the 40% growth, which we've talked about, stays intact. We feel -- still feel good that we should be able to get to that 40% in 2019. We also -- we aren't guiding but that's our overall goal that we're shooting towards. The next slide 10 just shows the disruption that we've laid out in what we call the third generation amino assay digital technology. But we did announce at the beginning of this year that we're going to go for another 100x in sensitivity. And this is important because as customers use our technology and the cerebral spinal fluid, they're learning that there are sub protein groups called protein translational modifications that are about one, I'd say, 50 of -- the concentration of the larger total protein level and they're able to see it in the cerebral spinal fluid with our technology and they're asking now, can we get to see those in blood, those protein translations, and we think that by going 100x, we're going to open up a whole new frontier of science by enabling that, not just for neurology, but also oncology. The next slide just shows a competitive roadmap. We continue to focus on improving the multiplexing our menu and lowering our costs and we feel like we've really honed in on two different platforms that's enabling us to be superior across what we will call the direct competition. But we also know we have competition coming to us from many different facets, particularly as we evolve the business into the imaging could become some somewhat competitive with us. But these are markets that we're moving into that makes those competitors that we're trying to disrupt. You can see in slide, the next slide 12, the whole point of our basis here is today, it's very invasive to see cancer and neurological disorders, either spinal tap or a biopsy and it's pretty late in the disease. And so what we're really about is non-invasively, through blood, through saliva, being able to see much earlier the disease and allow it to be then treated much more productively with drugs. And if you can see these diseases very early with our biomarkers, it gives the drug companies a better chance of actually treating the disease, because it's earlier stage and they can do it with less dosing, which makes those drugs safer. And we know that the safety and toxicity of drugs is still one of the biggest issues in the industry. The next slide just gives you an understanding of how this neurological pathway has occurred. It all started with the NIH basically looking at post-traumatic stress disorders in soldiers and seeing concussions in blood. That led to us winning the NFL General Electric health challenge twice. At the same time, the movie concussions was coming out, we got put on Good Morning America. And we talked the world that we could see these biomarkers in blood for neurology and that led then to a myriad of publications, third-party trials by neurologists around the world and all of these different disease categories, Alzheimer's, TBI, concussion, multiple sclerosis, and now we're seeing a lot of work in Parkinson's. The next slide just shows how rapidly that has ramped up and you might have seen recently about three weeks ago where -- there was a major CNN interview where one of our scientists, not of ours, but one of our collaborators from Europe, a neurologist, was able to look at familial Alzheimer patients where they can predict when symptoms of dementia are going to hit. And they were able to see elevations of NFL 16 years before the dementia. And that got a lot of excitement in many of the neurological journals around the world because if you can see Alzheimer’s that early and know that the disease cascade has started and you have a biomarker that can look at disease progression, it's a way to help the drug industry to change into a much more objective model ways to get drugs approved and we're pretty excited about that future opportunity. So the next slide just says, if you look at how our business has benefited from all these publications, you can see the pubs have got -- having a compound annual growth rate of 139% and that's led to our biomarkers growing to 67% and then our instruments growing at 67% and as you know, we've had triple digit growth in many of the quarters for neurology for our consumables, which is basically like the K cup going across the current coffee maker and we have 80 different K cups, different proteins that we're looking at across primarily oncology and neurology. The next slide shows that the number of NFL publications itself have really skyrocketed, have somewhat gone [indiscernible]. We've seen a major exponential growth and that has enabled some pretty big breakthroughs, particularly in MS where we actually estimate right now that there's 62 drug trials underway for multiple sclerosis and there's already $22 billion worth of approved drugs in the marketplace, attempting to help multiple sclerosis patients from staying out of a wheelchair, by slowing down the disease progression and they typically look today at MRI as somewhat of a late stage endpoint to look at MS progression that could take 2 to 2.5 years to see brain atrophy from the MS disease progression on the body. And there was a belief in a lot of these publications, you can see neuro-filament light in blood much earlier being an indicator of disease progression. And that's why it's now being used, we estimate, in 10 different drug trials looking for to be a surrogate endpoint. That led us to run a trial this past year where we went across 17 different sites that have our technology around the world. And we ran a study and then on slide 19, you can see that the NFL ended up being perfect and the CVs were less than 10%. That's the coefficient of variance. This is a very important analytical achievement on our technology for its repeatability. And it was really well done across all of our collaborators. And we're real excited. That's a key step in scaling this technology. And the next slide basically not only describes the fact that we've done really well with the NFL, particularly for multiple sclerosis, but you can start to see that there are publications coming for Alzheimer's and TBI and ALS and Parkinson's. And those diseases are actually a lot bigger, particularly Alzheimer's is a lot bigger than MS. And so the next slide is our attempt to say someday, we're hopeful that there'll be a blood test that could play a role that will allow you to see Alzheimer’s very early and then maybe move you into imaging where today there's actually beta amyloid PET scan already as an approved diagnostic for Alzheimer's. And they've now approved a cerebral spinal fluid test for Alzheimer's, looking at beta amyloid and we have evidence and I'm going to show you in a subsequent slide that we can already see amyloid, the beta amyloids with very high levels of repeatability and accuracy. And we think that this is a game changing opportunity that we're going to be working with most of the bio-pharmas that have interest in Alzheimer pipelines to try to help use it to further advance our technology. This next slide just goes through three of the big publications in the area of Alzheimer's and the progress we're making. We already mentioned the CNN, but there's also been this really nice publication on beta amyloid, measuring Aβ42 and Aβ40, two of our markers that that we measure in our Simoa and that's where we got an area under the curve of 95% and that's without optimizing it. So we're really excited that this could be the beginnings of CNN blood a much less invasive way than the cerebral spinal fluid, spinal tap, the beginnings of Alzheimer's. And this next slide is just the actual publication that showed the Alzheimer's 16 years before symptoms and the slide after that is the actual data on the area under the curve. So I'm going to close by just showing this last slide, which if you go to our website, we've got several links that you can click on and then see videos of the recent Powering Precision Health Summit, where many of the researchers from around the world are interviewed and they describes how neuro-filament light, NFL is going to transform many of this scientific landscape for seeing brain health in blood. And we also had recent interviews on ABC and Bloomberg Radio that you can click on and see as well. So that's all in our deck that just give you more evidence of the progress we're making. And I'd like to do now is turn over to Joe for a financial report.