Lishan Aklog
Analyst · Lake Street. Please go ahead
Thanks, Adrian and thank you all. Good afternoon for joining us on this PAVmed's quarterly update call. I would like to first start by thanking our long-term shareholders for their ongoing commitment and support. You'll note that this quarter, we're using a new format with a webcast in response to feedback, including one of our long-term investors in Boston. We're really happy that we've done this. So far, the feedback from the recent webcast yesterday has been uniformly positive. I'll remind you, speaking of Lucid that will present a tear down update on Lucid today, and encourage those of you who want to seek more details to review the webcast as yesterday's dedicated listed Update Call and that will be available for a week on the Investor Relations page on Lucid's Web site. So during this past quarter and the recent weeks, our team has continued its relentless focus on executing on our long-term strategy and our vision to build a high growth diversified medical technology company. Lucid, Veris and technology teams are all delivering results which are steadily advancing us towards that goal, and are doing so I'm proud to say it's on schedule and under budget, as we continue to keep a close eye on cash preservation to protect our long-term position. So let me start with a few quarterly updates, starting with Lucid. As we reported yesterday, EsoGuard testing volume increased 20% sequentially quarter-to-quarter, and 436% annually to 1,088 tests in the third quarter. We now have 13 Lucid Test Centers operating in 11 states and we plan to open three more during the fourth quarter. The laboratory is operating independently and we demonstrated enhanced quality and efficiency metrics on yesterday's call. And as we noted, we started to receive payments recognizing revenue on each of our claims started submitting in August. Very excited that the various cancer care platform has progressed well. And it is now proceeding towards initial launch later this year. All of the key pre-commercial development projects -- products, including Mercury, CarpX ultrasound, and EsoCure are all progressing well, ultimately towards design freeze development, testing and regulatory submission. And as I mentioned, from our overall balance sheet point of view, we've been able to continue to be active and execute our growth strategy, while preserving cash and [indiscernible]. Just a couple of introductory slides on PAVmed. PAVmed is a diversified commercial stage medical technology company. We started in the medical device space, but we've diversified over the years to include both diagnostic sector and digital health sectors. Corporate structure currently consists of two, by majority owned subsidiaries which is diagnostics and publicly held company in the medical diagnostic space and various health or digital health company which remains privately held. PAVmed model has evolved into a shared services model where PAVmed provide comprehensive shared services to its subsidiaries and other internal business units that you can see on the slide, with everything from administration, HR, Finance, product development, I see regulatory manufacturing clinical research and others are provided at a PAVmed level on behalf of the subsidiaries and business units and that provides us with a variety of key benefits for the company and we believe for our long-term shareholders in terms of economies of scale, facilitates diversification that impact on our cost of capital and also our growth potential. PAVmed's current portfolio can be divided into the commercial products, pre-commercial products that are on a clear path towards commercialization, and then projects which remain in the R&D realm. On the commercial side, we have two Lucid products, [indiscernible] EsoCheck. We continue to do commercial cases with the first generation complex device. On the pre-commercial side we have the CarpX ultrasound product. We have the two Veris products, both software platform, the cancer care platform as well as several iterations around Veris smart port and then EsoCare, which is our Esophageal Ablation Device which is complementary to with our EsoGuard and EsoCheck product. We also continue to work on R&D projects, our NextFlo and PortIO, and I'll touch on this a little later. Just a few summary slides to get on Lucid, which are -- you can pair down from our update yesterday. As we mentioned, our growth of the testing volume for EsoGuard testing has been continued to steadily increase, 28% from the last quarter. This growth has been driven by combination things, increased personnel in the field which I'll show you as well as improved sales training and data driven processes. And I've said repeatedly that we view this as a mid throttle [ph] strategy, we're not full throttle yet. We want to generate sufficient test volume to demonstrate our ability to grow testing volume and to demonstrate physician adoption as well as to generate claims history, which is important for long-term contracting in our contracting with payers. I described this in a bit more detail yesterday, but briefly, the volume has shifted to include about 22% of patients that have been tested were tested or performed at satellite Lucid Test Centers where our own nurse practitioners, co-located at a physician practice and we're excited about the expansion opportunity that comes with that new model. I mentioned, we continue to steadily grow according to plan and expand our sales team can see here we were up to 37 professionals on the team. And as we've described over the last couple of quarters, our plan is to continue that growth and plateau at a level of approximately 58 sales professionals. That time period has been pushed into the first quarter at the end of this year and we expect to reach that number by mid first quarter. The plan from that point on is to use that 16, but we believe we'll be able to continue to drive test volume growth through an increased experience or medium rep right now has only been in the field for a month or two. And we believe it takes [indiscernible] 4 months to be fully effective. Similar story with our Lucid Test Centers. Our goal is we have 11 states covered right now with 13 centers, we look to expand that with an additional three by the end of the year. And that won't get us to 16. And again, we are planning this to plateau there, not planning on opening additional test centers and allow the current drivers of growth to support that work with our expanded sales infrastructure. Just a couple of comments about the laboratory. We've -- those of you know we've taken over the operations in the laboratory starting in February. And we've seen some dramatic improvements and many parameters, operational parameters and quality parameters, showed some more detail yesterday, perhaps the most relevant one from the point of view of patients and physicians is that we have the turnaround times now down to a record low of just under a week. And as I've also described in more detail yesterday, the process by which we are able to submit claims has improved and we started that process in August. We have about 2,000 plus claims that we've held since the laboratory transferred to us in February. And we're in the process of submitting those claims, and we actually have started to receive even though that process started in August, claims paid in the past quarter. Just one comment about -- couple of comments about Medicare. If you look at the payer mix there you can see that our payer mix is heavily weighted towards private payers, about 11% are Medicare. With regard to the Lucid -- with regard to the LCD, as you may recall, back in the spring, we had a fairly intense amount of activity with the publication of a draft, local coverage determination, LCD; and a flurry of activity around the public comment period. Now that public comment period is over, we simply wait until MolDx, entities and affiliated with the medical -- Medicare Administrative Contractor to get around to reviewing the responses and responding to them. I just want to make one thing clear that there may have been some confusion on the call earlier as have been reports that MolDx was not engaging with us. And that's just not the case, we actually have had calls with MolDx, so we're going to call to discuss our clinical utility plan. But with regard to the LCD process, and that is not a interactive process, you just simply wait until they complete their review and then we will have the opportunity to respond after they published an updated LCD. On the private payer side, we continue to have conversations with private payers, but ultimately for us to have meaningful conversations we need two things to happen. We need increased claims history which we are just getting started to -- starting to do. And also clinical utility, which we're starting to collect. But as I mentioned so far we have had out of network payments that are getting paid at the full 50% to 60% out of network benefit and [indiscernible] respects, the target list price that we submit and those payments are coming in at about $1,200 to $1,400 which is gratifying. And as I discussed yesterday on the manufacturing side, we're really happy to transport our manufacturing of EsoCheck for high volume manufacture. And we're extracting immediate benefits with regard to decreased manufacturing costs as well as capacity and scalable, long-term scalable capacity. Let's move on to Veris Health. Veris Health is a digital health company that's developing a cancer care platform that combines patient engagement with smartphone and connected devices, along with an enhanced cancer care platform that the clinical care team can use to collect to view data on patients who have cancer, who are under their care and respond accordingly. And to do so in a way that's integrated with the electronic health record. The long-term plan is to incorporate smart device physiologic monitoring with an implantable form that has biosensors that allow for physiologic monitoring. The plan that we've described in previous call as to first launch will we referred to Veris Solar, which is the cloud connected platform, software platform in conjunction with various boxes connected Bluetooth enabled devices. Veris Mercury is our first effort to deliver an implantable smart port. This is a modular device that has an implantable physiologic monitoring device with a traditional vascular access cord. And then the final stage will be to have a fully integrated smart implantable vascular access network with the geologic and physiologic monitoring. So as I mentioned, and I'll talk a little bit more detail now. We are on the verge of launching the Veris platform by the end of this year on schedule, as we have previously described. So you can see on the left there, this is what we're launching our software platform, which has been completed and is completed testing and is now ready for launch. Along with Bluetooth connected health care measuring devices, you can see the activity monitors [indiscernible] monitor, blood pressure cuff, I think digital thermometer. And those are all Bluetooth connected to a hub that the company provides and allows those -- that data along with patients symptom reporting to be transmitted through the cloud to the physicians platform. On the commercialization side, we worked extensively with Deloitte Consulting to establish the market dynamics and to own our commercial strategy. We're quite excited about this model. It's a subscription based model with revenue -- with recurring revenue. The [indiscernible] practice will pay Veris a fixed subscription fee per seat. And they'll be able to build with remote patient monitoring, while RPM codes, which I've shown here which actually are established. They're not under threat of any revision, not a COVID era process. These are codes that have existed. And so really, from a reimbursement point of view, that's established. There's nothing for us to wait for there. There's also -- our platform will also facilitate telemedicine billing, which the physicians will have the opportunity to build as well. Overall, this gives them an opportunity to have a significant net contribution margin, again, based on this existing reimbursement. An additional area that we've learned at our initial engagements now with potential clients is the new enhancing oncology model, which is a CMS program that I won't go into a lot of detail on, but basically uses incentives with regard to certain aspects of quality of care that would be enhanced with this kind of remote monitoring to provide financial incentives for practices that can actually be significant -- that can add significantly to the practice revenues. We're targeting the full range of oncology care, oncology practices, large cancer centers, integrated health networks, a bit of an early emphasis on rural practices, looking forward to -- for obvious reasons that we believe that remote patient monitoring will be beneficial. And we have our commercial team that's already been -- have that already been utilizing demos to interface with such practices and with potential clients. The other aspect of this, as you might imagine, is getting started with customer integration. So when we launch a site, there's a whole slew of things that have to be done to make sure that the practices, software, their EHR and so forth and complete fully integrated with our system. We hired a really talented and experienced person to lead this effort. He led customer engagement and ethics, the large electronic health records company and they’re doing a great job so far with us with establishing that infrastructure for customer integration. Our initial interactions with the -- with potential clients has been that there's a very, very strong focus right now on tools that can enable remote patient monitoring and everything that we've -- all the feedback we've received so far has been quite positive and we look forward to getting our first contracted customer by the end of this year and officially launching this product. Now with an overview of the other products within our portfolio. As I mentioned, we still continue to perform complex procedures utilizing the key opinion leaders at a low level to continue to provide us with procedural and product improvements. But as I've described previously, all of our efforts for a longer term expanded commercial launch are focused on the CarpX ultrasound device, that product is making good progress through its design and product development phases. We're starting to do cadaver work and getting and starting to get images that demonstrate that we're able to using this device to actually see the anatomic structures in the carpal tunnel and position them in a way so that the cutting can be done under direct ultrasonic measurement. So that's progressing well. The second area of focus on the pre-commercial products is that there are smart port, the middle of what we refer internally as Veris Mercury, which is the combination of the implantable cardiac monitor with an existing traditional payment board that’s also progressing well. We've had multiple interactions with FDA to understand and make clear what our preclinical testing will need to be for an FDA submission. We’ve engaged several high caliber outside contract manufacturing partners for the various electronics and enclosures and so forth. And again, and also animal work. And so again, that's moving forward on track and looking forward to getting quickly to design freeze and moving towards the work that's required for regulatory submission. Very much a similar story with EsoCure, if you recall it. EsoCure is a device that was looking to compete with the Medtronic device for ambulating dysplastic Barrett's Esophagus. So it obviously it has synergies with the EsoGuard, EsoCheck products. It uses direct thermal energy instead of radiofrequency. And we are also making good progress with the -- both the catheters, the console electronics, all the mechanical aspects of it had multiple animal studies which have shown really promising results and including indirect head to head comparisons with [indiscernible] there. So again, on target, on schedule to advance through design freeze and ultimately towards [indiscernible]. A few comments about our R&D projects, those of you who've been involved with PAVmed for a long time, now the next one, just a brief recollection of that history. We had hoped and planned to have NextFlo actually complete the pre-submission testing and go for regulatory submission. In the first half of this year, we were getting really good regulation of flow, which was the whole point of this technology. But we encountered some technical challenges during the -- on repeatability during the last eight stages of testing. And that required us to kind of go back to the drawing board and relegate NextFlo back to being an R&D project. We're still very committed to the concept. We think it is a good market opportunity here. And there's a lot of activity right now in the R&D side, but right now, we're still unknown what the solution will be and when we'll be able to bring this back on to a pre-commercial path [ph]. PortIO, it is our Implantable Intraosseous Vascular Access Device. Again, we -- that remains an R&D project. We have first generation device that continues to undergo first in human testing in Colombia that's going well. The device works, we've had no complications associated with IT and we're continuing to expand the number of patients. Our long-term plans with this depends a bit on a revised regulatory strategy, our new -- had a regulatory new VP of regulatory quality has engaged with us on a process to develop a more streamlined plan than we had previously thought we relegated to, and depending on how that goes, we may move this up into the pre-commercial realm after we've completed the first [indiscernible]. So with that, I'll end and I'll hand the reins over to Dennis to give us financial update.