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Earnings Call: Q3 2022

Nov 15, 2022

Operator

Ladies and gentlemen, greetings and welcome to the PAVmed Inc. third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Adrian Miller, Vice President of Investor Relations. Please go ahead.

Adrian K. Miller
VP of Investor Relations, PAVmed Inc.

Thank you, operator. Good afternoon, everyone. This is Adrian Miller, Vice President, Investor Relations at PAVmed. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed, along with Dennis McGrath, President and Chief Financial Officer of PAVmed. The press release announcing our business updates and financial results is available on PAVmed's website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The business update press release and this conference call both include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC.

For a list and description of these and other important risks and uncertainties that may affect future operations, see Part One, Item 1A, entitled Risk Factors in PAVmed's most recent annual report on Form 10-Q filed with the SEC, and subsequent updates filed in quarterly reports on Form 10-Q and any subsequent Form 8-K filings. Except as required by law, PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. With that said, I would like to turn the call over to Lishan Aklog. Dr. Aklog.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Thanks, Adrian, and thank you all. Good afternoon for joining us on this PAVmed's quarterly update call. I'd 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 from one of our long-term investors in Boston. We're really happy that we've done this. So far the feedback from the Lucid webcast yesterday has been uniformly positive. I'll remind you speaking of Lucid, that we'll present a tear down update on Lucid today and encourage those of you who want to seek more details to review the webcast of yesterday's dedicated Lucid update call. That'll be available for a week on the investor relations page on Lucid's website.

During this past quarter and in 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. The 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, on schedule and under budget as we continue to keep a close eye on cash preservation to protect our long-term position. Let me start with a few quarterly updates, starting with Lucid. As we reported yesterday, EsoGuard testing volume increased 20% sequentially, quarter-over-quarter and 436% year-over-year 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've demonstrated enhanced quality and efficiency metrics on yesterday's call. As we noted, we started to receive payments recognizing revenue on EsoGuard claims that we started submitting in August. Very excited that the Veris Cancer Care Platform has progressed well, and it is now proceeding towards initial launch later this year. All of the key pre-commercial development products, excuse me, Veris Mercury, CarpX Ultrasound, and EsoCure are all progressing well ultimately towards design freeze, development testing, and regulatory submission.

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 we're well under budget. 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 the diagnostic sector and the digital health sectors. Corporate structure currently consists of two majority-owned subsidiaries, Lucid Diagnostics, a publicly held company in the medical diagnostics space, and Veris Health, our digital health company, which remains privately held. PAVmed's model is evolved into a shared services model where PAVmed provides comprehensive shared services to its subsidiaries and other internal business units.

As you can see on the slide, we have everything from administration, HR, finance, product development, IT, regulatory, manufacturing, clinical research, and others are provided at the PAVmed level on behalf of the subsidiaries and business units. 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. It facilitates diversification, has an 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. From the commercial side, we have two Lucid products. These are our EsoCheck. We continue to do commercial cases with the first-generation CarpX device.

On the pre-commercial side, we have the CarpX Ultrasound product. We have the two Veris products, both the software platform, the cancer care platform, as well as several iterations of our Veris SmartPort. Then EsoCure, which is our esophageal ablation device, which is complementary with our EsoGuard and EsoCheck products. We also continue to work on other R&D projects on NextFlo and PortIO, and I'll touch on this a little bit later. Just a few summary slides again on Lucid, which are again pared 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 a combination of things, increased personnel in the field, which I'll show you, as well as improved sales training and data-driven processes. I've said repeatedly that we view this as a mid-throttle 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 our long-term contracting and network 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 performed at satellite Lucid test centers, where our own nurse practitioners co-located at a physician practice.

We're excited about the expansion of opportunity that comes with that with that new model. As I mentioned, we continue to steadily grow according to plan, expand our sales team. You can see here we're up to 37 professionals on the team. 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, but we expect to reach that number by mid-first quarter. The plan from that point on is to use that fixed team, but we believe we'll be able to continue to drive test volume growth through an increased experience.

Our median rep right now has only been in the field for a month or two, and we believe it takes up to four 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 will get us to 16. Again, our plan is to plateau there and not plan 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.

As those of you know, we've taken over the operations of the laboratory starting in February, and we've seen some dramatic improvements in many parameters, operational parameters and quality parameters. I showed some in 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. As I've also described in more detail yesterday, the process by which we are able to submit claims has improved. 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.

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 a couple 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 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, the entity that's affiliated with the Medicare administrative contractor, to get around to reviewing the responses and responding to them. I will just wanna make one thing clear, that there may have been some confusion from the call earlier, as there've been reports that MolDX was not engaging with us, and that's just not the case. We actually have had calls with MolDX. We got a call to discuss our clinical utility plan. With regard to the LCD process, that is not an interactive process. You just simply wait until they complete their review, and then we will have the opportunity to respond after they publish 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're just getting started to do, and also clinical utility data, which we are starting to collect. As I mentioned, so far we have had out-of-network payments that are getting paid at the full 50%-60% out-of-network benefit at the rate that respects the target list price that we submit.

Those payments are coming in at about $1,200-$1,400, which is gratifying. As I discussed yesterday, on the manufacturing side, we're really happy we've transferred our manufacturing of EsoCheck to a high-volume manufacturer, and we're extracting immediate benefits with regard to decreased manufacturing costs as well as capacity and a 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 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 port that has biosensors that'll allow for physiologic monitoring. The plan that we've described in previous calls is to first launch what we refer to as Veris Solar, which is the cloud-connected platform, software platform in conjunction with a Veris box of 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 port. The final stage will be to have a fully integrated smart implantable vascular access port with physiologic monitoring.

As I mentioned, and I'll talk a little bit more in a little more detail now, we are on the verge of launching the Veris platform by the end of this year on schedule as we had previously described. 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 healthcare measuring devices. You can see activity monitors, scales, a O2 sat monitor, a blood pressure cuff, and a digital thermometer. Those are all Bluetooth-connected through a hub that the company provides and allows that data, along with patient symptom reporting, to be transmitted through the cloud to the physician's platform.

On the commercialization side, we worked extensively with Deloitte Consulting to establish the market dynamics and to hone our commercial strategy. We're quite excited about this model. It's a subscription-based model with revenue, with recurring revenue. The practice will pay Veris a fixed subscription fee per seat, and they'll be able to bill with remote patient monitoring or RPM codes, which I've shown here, which actually are established. They're not under threat of any decision. That is not a COVID-era process. These are codes that have existed. Really from a reimbursement point of view, that's established. There's nothing for us to wait for there. Our platform will also facilitate telemedicine billing, which the physicians will have the opportunity to bill 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 in 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, so oncology practices, large cancer centers, integrated health networks.

A bit of an early emphasis on rural practices which for obvious reasons we think that we believe this remote patient monitoring will be beneficial. We have our commercial team that's already been utilizing demos to interface with such practices and with potential clients. Another aspect of this, as you might imagine, is getting started with customer integration. When we launch a site, there's a whole slew of things that have to be done to make sure that these practices software, their EHR and so forth can be fully integrated with our system. We hired a really talented and experienced person to lead this effort.

He led customer engagement at Epic, the large electronic health records company, and has been doing a great job so far with us with establishing that infrastructure for customer integration. Our initial interactions with potential clients has been that there's a very strong focus right now on tools that can enable remote patient monitoring. 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. I'll end now with an overview of the other products within our portfolio. As I mentioned, we still continue to perform CarpX procedures utilizing the key opinion leaders at a low level to continue to provide us with procedural and product improvements.

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 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 vision. That's progressing well. The second area of focus on the pre-commercial products is that Veris SmartPort, the middle one, which we refer internally as Veris Mercury, which is the combination of the implantable cardiac monitor with an existing traditional chemo port. 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 with several high caliber outside contract manufacturing partners for the various electronics and enclosures and so forth, and also animal work. 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, EsoCure is a device that is looking to compete with the Medtronic device for ablating dysplastic Barrett's esophagus. Obviously it has synergies with the EsoGuard and EsoCheck products. It uses direct thermal energy instead of radio frequency.

We are also making good progress with both the catheters, the console, all the electronics, all the mechanical aspects of it. Had multiple animal studies which have shown really promising results and including in direct head-to-head comparisons with the Medtronic Barrett's device. Again, on target, on schedule to advance through design freeze and ultimately towards regulatory submission. A few comments about our R&D projects. Those of you who've been involved with PAVmed for a long time know about NextFlo. 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 flow regulation, which was the whole point of this technology.

We encountered some technical challenges on repeatability during the last stages of testing. 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 there's a good market opportunity here, and there's a lot of activity right now in the R&D side. Right now it's still unknown what the solution will be and when we'll be able to bring this back onto a pre-commercial path. PortIO is our implantable intraosseous vascular access device. Again, that remains an R&D project. We have a 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 depend a bit on a revised regulatory strategy. Our new VP of Regulatory Quality has engaged with us on a process to develop a more streamlined plan than we had previously thought we were relegated to. Depending on how that goes, we may move this up into the pre-commercial realm after we've completed the first in-human study. With that, I'll end, and I'll hand the reins over to Dennis to give us our financial update.

Dennis M. McGrath
CFO, PAVmed Inc.

Thanks, Lishan, and good evening, everyone. You see in front of you the balance sheet. Our summary financial results for the third quarter are reported in our press release that was published earlier today. On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered on our quarterly report on Form 10-Q that was filed with the SEC yesterday afternoon and is available on our website. As you can see here, cash, the sequential decrease was $8.4 million. Vendor payables had a $3 million sequential decrease when considering accounts payable and other recurring accrued expenses. Convertible note, a net increase of $6 million driven by $10.2 million net proceeds from the issuance of an additional convertible note.

It was offset by $5 million of principal converted to equity related to the April 2022 note. As mentioned yesterday, the committed equity facility from Lucid, stock issuance proceeds for the quarter were $1.8 million, most of which we had already reported to you as part of our update in August. Shares outstanding for PAVmed, including unvested restricted stock awards, as of today is 93.2 million shares. As also mentioned yesterday, Lucid is now S-3 eligible and is previewed with everyone previously. Similar to what we have previously done at PAVmed, the Lucid board considers a good governance to have a shelf registration with an embedded ATM on file with the SEC, and Lucid will plan to do so in due course.

Slide 18 here compares this year's third quarter to last year's third quarter on certain key items. I trust you'll review the information and my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly the non-GAAP information. Revenue for the quarter reflects 39 EsoGuard tests at an average payment rate of $1,945 per test. The rate is slightly higher than the $1,938 Medicare rate, as we received one payment closer to our ASP of $2,499 than the Medicare rate that skewed things slightly higher. The prior year reflects the fixed monthly fee received from the third-party lab that Lucid used before setting up our own lab earlier this year. Revenue recognition. A key determinant is the probability of collection.

We've mentioned this multiple times in the past. For the vast majority of Lucid patient out-of-network claim submissions means revenue recognition occurs when the claim is actually collected versus when the patient report

Is invoiced and submitted for reimbursement. As you'll see in our 10-Q, this is called variable consideration in the jargon of GAAP ASC 606 revenue recognition, which we all have to live by those guidelines. Presently, there is insufficient predictive data to recognize revenue when invoiced. Our GAAP loss is slightly higher, about 2% higher, and our non-GAAP loss is slightly lower, about 5% lower for the third quarter due to the effect of higher non-cash charges in the current quarter related to convertible debt. Those comparisons are sequential comparisons. Our non-GAAP loss per share is $0.15 for the third quarter, compared to a loss of $0.17 per share in the previous quarter. Slide 19 here is a graphic illustration of our operating expenses as presented in detail in our press release.

The total GAAP and non-GAAP OpEx was relatively flat sequentially. The cost of revenue primarily consists of EsoCheck devices, lab supplies, and fixed lab monthly or facility costs, and is now being presented in our 10-Q as operating expense consistent with the practices of other diagnostic companies. Sales and marketing was slightly lower, about 5% sequentially. G&A also decreased about 9% sequentially, and some of that reflects an allocation of about $800,000 of lab costs in the prior quarter as no revenue was recognized in that quarter and therefore the typical cost of revenue type expenses are reclassified to G&A in that previous quarter. R&D decreased 8% sequentially. With that operator, let's open it up for questions.

Operator

Thank you. Ladies and gentlemen, at this time we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question comes from the line of Frank Takkinen from Lake Street. Please go ahead.

Charlie Montang
Equity Research Associate, Lake Street Capital Markets

Good evening. Hi, guys. This is Charlie Montang on for Frank. Just a couple quick questions for me. Just first on the Lucid front, I heard your comments about the plateauing centers. I assume that does not mean indefinitely. Can you maybe just talk what you're looking to see before re-accelerating openings and maybe any feel for timing around that?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Sure. Let me just start by emphasizing one thing, just to keep hammering this point, that the Lucid test centers support the growth. They're not drivers of growth, right? They're not. They don't generate actual activity. They're there available for tests that are ordered by physicians through our sales and marketing process to actually perform tests. Also, I just want to emphasize one thing real quick, Charlie, before answering as well, which is that we have now expanded our use of the satellite Lucid test centers, where our nurse practitioners can be more mobile and work within those centers. The plateauing of the Lucid test centers mirrors. It's part of the same strategy of plateauing our sales force altogether.

This is something we described in a bit more detail, I believe it was on the last quarterly call, that as part of our efforts to be cautious with regard to cash preservation, we set a target for both of those that we thought would give us critical mass with regard to the sales team and then with sufficient support with Lucid test centers to support the sales team, where we could continue at a fixed level to drive growth through increased effectiveness of the sales force as they get more time in the field and so forth. All of that is really driven by this mid-throttle strategy, right?

We wanna have enough activity so we can demonstrate ongoing sales growth to get the word out, to continue our momentum with physicians and physician adoption, where we need to continue that growth as well to generate claims history, which is a critical step, one of the critical steps in engaging private payers for in-network contracts. To do so cautiously at a mid-throttle level because we still are not at the point where we have predictable reimbursement. The answer, I think, to the last part of your question is this some permanent thing? No, it isn't.

It's really just a, you know, we're pausing at a level that we feel confident that will allow us to continue to drive test volume growth, but while keeping our costs in check, and that, you know, pivoting from that will be a function of what we see with regard to both the trajectory of out-of-network payments and the percentage of the Lucid tests that are paid out-of-network. Again, as we've emphasized, we've been quite happy with the payments that we're getting. We just don't have enough of a sample size yet to know what percentage of the tests will generate that volume.

Of course, as we collect clinical utility data and we engage with private payers, we'll start seeing some in-network payments as well. It's really a holding pattern that we believe will continue to still drive test volume growth. The holding pattern until we get with regard to the infrastructure, until we get more predictable reimbursement numbers, we just think that's the appropriate sort of prudent thing to do from a cash preservation point of view.

Charlie Montang
Equity Research Associate, Lake Street Capital Markets

Great. Okay. Thank you, and thanks for kind of clearing that up for us. My other question, just with looking at the balance sheet, it looks good. Last quarter you called out modulating spend across your asset portfolio outside of Lucid with a focus on the most near term and largest opportunities. Have your capital allocations changed at all since then, or should we continue to think the order of prioritization is Veris and CarpX?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Oh, it's Veris exactly what we described, and we've stuck to that plan, and you can see, you know, where we are seeing some savings already on the R&D side. It is entirely at this point from the non-Lucid. Well, let's just put it in the two for now. We obviously have the commercial products with Lucid. Very soon, we'll have the commercial software product with Veris, the Veris Solar software platform. That'll be out in the commercial realm. When it comes to the investment of resources, capital allocation, as you say, into the product portfolio, the focus is heavily and remains the same on those three products.

The three products being the ultrasound version of CarpX, the first version of an implantable Veris device, that Veris Mercury product, and the EsoCure esophageal ablation product. Those, that is where we are focusing our resources and capital allocation. We're not shutting, you know, we continue to apply some effort on the two research projects which I described, but those are relatively modest investments. It's pure R&D work at this time. Then as we talked about last time, we have rationalized and put on the back burner a number of lower priority, lower yield, we believe, higher risk projects that we've been working on, and those remain on the shelf.

Charlie Montang
Equity Research Associate, Lake Street Capital Markets

Okay, great. Thank you very much. Just if I can, just one last quick question.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Sure.

Charlie Montang
Equity Research Associate, Lake Street Capital Markets

You spoke to a commercial agreement with MediNcrease in May. Can you give us an update around that contract and call out whether or not you have received reimbursement under that contract, and if so, kind of at what level?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Just to remind you, that was the first example, but since then we've reported on multiple. I believe we have 7. Correct me if I'm wrong, then the seven or eight similar secondary PPO contracts. We have not broken down that data, and we're not reporting on those individual plans at this point. That would be sort of too granular at this level with the sample size. I think we'll just suffice it to say that, you know, you saw we had 39 payments in this quarter. Those are a mix of a variety of private payers. Dennis gave you the data on the average payment, which was just a bit over $1,900.

Also that the out-of-network payments that are coming in are $1,200-$1,400. You know, as we get higher, more volume and we have a sample size that's large enough, you know, we will certainly be in a position to kind of break down, you know, where that, where those payments are coming to, whether they're from secondary PPO from out-of-network with traditional payers, eventually with Medicare and so forth. I think it's a bit premature to break. Dennis, would you like to add anything to that?

Dennis M. McGrath
CFO, PAVmed Inc.

No, I agree. It's too early to kind of give any kind of directional information that's reliable to be able to create some kind of forecast based upon the information that we've gotten so far. It's just too early in the submission process and the collection process.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yeah. I mean, the bottom line, Charlie, is that the 39 payments, the tests that we submitted in August and got paid before September were private pay. It was a mix of different payers. We'll you know, look forward to increasing that and perhaps at some point breaking that down further.

Charlie Montang
Equity Research Associate, Lake Street Capital Markets

Okay, great. Thank you very much, and thanks for answering my questions.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yeah.

Charlie Montang
Equity Research Associate, Lake Street Capital Markets

I'll hop back in the queue.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Thanks, Charlie.

Dennis M. McGrath
CFO, PAVmed Inc.

Thank you.

Operator

Thank you. Our next question comes from the line of Edward Woo from Ascendiant Capital Markets LLC. Please go ahead.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Hello, Ed.

Edward Woo
Director of Research and Senior Analyst, Ascendiant Capital Markets, LLC

Yeah. Thanks for taking my question, and congratulations on the progress. I know you are very focused with your capital, you know, allocation right now, but what are you seeing out there in terms of the M&A space and opportunities for adding new products into your portfolio? Have you seen valuations come down significantly to a point where you're seeing, you know, interesting opportunities out there, or are valuations still, you know, all over the place?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

The answer is yes, and I always appreciate you asking that call because I, you know, there's not a lot that I can talk about sort of directly. There are a lot of opportunities out there, and as has historically been the case, we get to see a lot of opportunities within the space, and we get to evaluate them. You're right. I mean, the markets are. There are companies that are tight for cash and for a variety of other reasons are looking to partner or to be acquired and so forth. There's a lot of activity there. Nothing to report yet. We'll obviously, you know, let you guys know when we.

If and when we cross the threshold with any of the opportunities that we're looking at. Just let me just reiterate one other point I made last time, which is that, you know, our cash preservation stance is important. It's important that we maintain our runway and protect our long-term interests. I've also said repeatedly that we're not gonna sort of violate our core DNA of this company, which is to pounce on attractive opportunities as we see, just like we did with Lucid and with Veris. The profile of what that would look like is obviously a bit different now than it would have been two, three years ago.

We are, you know, looking at opportunities with a very close eye on the opportunity for them to either be synergistic with our current portfolio in some way and to not be a capital drain and to be accretive in some capacity in the near future. Those are the criteria we look at. We have opportunities we have looked at and continue to look at, and we'll let you know when and if we cross the threshold.

Operator

Great. Well, thank you, and good luck.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Thanks, Ed.

Operator

Thank you. Our next question comes from the line of Anthony Vendetti from Maxim Group LLC. Please go ahead.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Anthony, good evening.

Dennis M. McGrath
CFO, PAVmed Inc.

Hey, Anthony.

Hi. Good evening, Dennis. Hi, Lishan. How are you?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Great.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Wanted to just dig a little deeper into the commercial launch for Veris.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yeah.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

By the end of the year. Can you talk a little bit about that particular business model and what the pipeline of potential customers looks like at this point?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yeah. Let me start with the latter. The pipeline of potential customers are really the full spectrum of oncology practice. That should vary. Now, we were really fortunate. We have a good relationship with Deloitte, and we did an extensive market analysis with them, so we have a really good understanding of where these on where patients get their care for their cancer, and it can vary anywhere from relatively small private practices to larger larger practices, even, you know, mega practices as well as cancer programs that are affiliated with moderate-sized community hospitals all the way up to the big academic medical centers. Really all of them are targets for us.

As I mentioned, you know, there is an obvious opportunity with rural practices in terms of the advantage, their patients tend to be more dispersed and the advantages of remote patient monitoring are particularly potentially greatest with that group. You know, the business model is, I'll just sort of, you know, dive into that a little bit deeper. It's we engage with the practice.

When we engage with them, we have demos now that show how the software platform can be fed with patient symptom reporting as well as data from these Bluetooth-connected devices and provide them with data to not just enhance their care, but also to provide them with the opportunity to record activity that can be reimbursed as remote patient monitoring or RPM. RPM is sort of a hot topic right now. You know, setting up a system that allows physicians to bill under RPM codes, again, these are established codes. They're not transient codes like some of the telemedicine codes that came from COVID.

You know, requires really good software platform, and our feedback so far has been quite positive. We found that the practices are very focused on RPM codes and the opportunity to enhance their practice revenues through RPM and that our platform does in fact do that. One of the things that you have to do in order to bill for RPM codes on a monthly basis is they have to show that the patient submitted data of some kind from a device, an FDA-authorized device, at least 16 days of the year. That requires a really good platform that's engaged with the patient, that encourages them to measure the various parameters you're trying to measure.

Just forward-thinking, once we have an implantable device, that'll obviously be fixed because that's not gonna depend on patient engagement and patient compliance. You know, as I mentioned, there's the other part. The value added here comes from being able to integrate within their IT system. The process of integrating with their electronic health record and other aspects of their IT infrastructure requires some talent and skill on our part, and we're really happy that we recruited someone who's able to help us with that type of engagement and has a lot of experience with that.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Okay.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

That's a little bit of repetition of what I said, but perhaps there was more details that you wanted to dive into there.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Yeah. No, that's great. That's great. Then just a quick follow-up before just a quick question on CarpX. So, you know, there's debate about how much coverage CMS, which expanded coverage of telemedicine during COVID, will currently allow to continue. In terms of remote patient monitoring, are there particular CPT codes right now?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yeah. Absolutely.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

That this will fall under and.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yeah, yeah. It's actually on slide 15. There are codes for the one-time onboarding, for the per monthly fee. So, I list them all on slide 15, and those are not. Again, just to emphasize for the third time, those are not temporary codes that have been in place. The telemedicine codes were brought in under COVID and are subject to ongoing sort of statutory updates, but these RPM codes are not. So they're there, and the codes are well established, the payment rates are well established, the criteria under which you can bill are well established with regard to the 16 days a month. So all of that infrastructure and reimbursement is established.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Okay, great. That's helpful. Then, before switching to CarpX, 37 sales professionals going to 58, is that 100% for Lucid?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Yes, that's for Lucid. Yeah, we're not. We haven't reported on the commercial team for Veris yet. Veris is just obviously. We're just gearing up with that. We have sales leadership in place. We're starting to recruit individual sales reps. Right now, the sales leadership, they're the ones who are actually out and looking and you know scouring for early adopters to the Veris technology. We'll report on the Veris sales team over time.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Okay.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

On CarpX we do have.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Yeah.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Three individuals, the same individuals that we've had throughout this limited procedural and product improvement focused launch, and they remain the same.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Okay. Any feedback from KOLs on CarpX at this point?

Lishan Aklog
Chairman and CEO, PAVmed Inc.

The CarpX activity right now remains that procedural and product development and product improvement work. We have our core group of KOLs. We look to expand them here and there, but we, as I mentioned before, we're not investing in expanding the team or expanding that activity beyond the limited number of KOLs we have. We're using this exclusively as a procedure in the product development exercise, and we're gonna await CarpX Ultrasound before gearing up for the full commercial launch.

Anthony Vendetti
Senior Research Analyst, Maxim Group, LLC

Okay, great. I'll hop back in the queue. Thank you very much. Appreciate it.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Just one follow-up. I know you're off-

Operator

Thank you.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

Can I just add one real quick, one quick follow-up to Anthony's last question, which is that as you might imagine, the surgeons on our KOL list who we do training with, we do cadaver work with, and they do a limited number of cases, we've obviously also shown them the CarpX Ultrasound device and the prototypes for that and where we're heading with that and the feedback on that, on the ability. These are folks who've done the procedure with the gen one device and the feedback of the opportunity to have intraluminal ultrasounds, ultrasound imaging as you're working within the carpal tunnel has been quite positive. We're utilizing those folks with CarpX experience to help us with that development process. Thank you, operator. Sorry about the interruption.

Operator

Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I would now like to turn the conference to Dr. Lishan Aklog, Chairman and CEO, for closing comments.

Lishan Aklog
Chairman and CEO, PAVmed Inc.

I'd like to again thank you all for joining us today. Really great questions from all the folks who came on and a really good discussion. Look forward to always being fully transparent with our communications and keeping you abreast of our progress. Keep an eye out for our press releases and obviously these quarterly calls. We appreciate any feedback. As I mentioned, the webcast version of this was a result of direct feedback from individual investors who asked us, gave us advice on how to improve our communications, and we're always open to that and look forward to more feedback, positive or negative. Please keep up to date. Sign up for our email alerts, and keep up to date with our social media feeds.

As always, Adrian is available for direct contact at AKM@PAVmed.com. Again, thanks everyone, and have a great evening.

Operator

Thank you. The conference of PAVmed Inc. has now concluded. Thank you for your participation. You may now disconnect your line.

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