PAVmed Inc. (NASDAQ:PAVM) Q4 2023 Earnings Call Transcript

PAVmed Inc. (NASDAQ:PAVM) Q4 2023 Earnings Call Transcript March 27, 2024

PAVmed Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good morning and welcome to PAVmed’s Fourth Quarter and Full Year 2023 Business Update Conference Call. [Operator Instructions] This call is being recorded on Wednesday, March 27, 2024. I would now like to turn the conference over to Dennis McGrath, PAVmed President and Chief Financial Officer. Please go ahead, Dennis.

Dennis McGrath: Thank you, operator. Good morning, everyone and thank you for participating in today’s third quarter — fourth quarter 2023 business update call. Press release announcing our business update for the company and financial results for the fourth quarter and the full year ended December 31, 2023, is available on the PAVmed website. Please take a moment to read the disclaimer about the forward-looking statements. 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 U.S. Securities and Exchange Commission.

For a list and a description of these and other important risk factors or risks and uncertainties that may affect future operations, see Part I, Item 1A entitled Risk Factors in PAVmed’s most recent annual report on Form 10-K 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 intention or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. I now would like to turn it over to Dr. Lishan Aklog, PAVmed’s Chairman and CEO.

Lishan?

Lishan Aklog: Thank you, Dennis and good afternoon, everyone. Thank you for joining our quarterly update call. Before proceeding, a couple of things. As yesterday, I’d like to apologize for my scratchy voice. I’m a little bit under the weather. I’d also like to thank our long-term shareholders for your ongoing support and commitment. We’ve been together through some challenging times. And as we’ll discuss in greater depth, we continue to leave no stone unturned to enhance long-term shareholder value. Lucid clearly remains PAVmed’s strongest and most promising asset and we’re very pleased by its commercial progress and Lucid’s ability to finance its operations despite challenging market conditions. We’re looking to replicate the model more broadly and have raised PAVmed’s — revised PAVmed’s overall strategy to drive shareholder value through independently financed subsidiaries which like Lucid, can leverage PAVmed’s shared infrastructure.

Consistent with this approach, we’ve updated Veris’ commercial strategy accordingly. We’ve launched our PMX incubator in partnership with Hatch Medical. And we’ve aggressively sought ground-breaking independently financeable technologies with large market opportunities agnostic of center. So a couple of — let’s just start with some recent highlights, starting with Lucid Diagnostics. A reminder that, yesterday, we had a full presentation regarding Lucid, so I would encourage everyone to view that webinar or the transcript of that webinar to get further details with Lucid. I’ll just give some highlights. Quarterly revenue rose nicely at 33% from the prior quarter. And these health fair high-volume CYFT events continue to gain traction. Our out-of-network reimbursement is improving with stable pricing and we’ve expanded our clinical validity and clinical utility data to support in-network coverage, including Medicare.

As I mentioned and I’ll talk about it in further — in more depth in a bit. For Veris Health, we’ve shifted our strategy to target large academic and regional cancer centers and our first such engagement is expected in the very near term. We had a final and successful FDA pre-submission meeting for the implantable monitor and we feel we have a clear path to FDA clearance, pending independent financing. As we announced last week, we launched — PAVmed launched its wholly owned incubator, PMX, in partnership with Hatch Medical to complete development and commercialization of its existing medtech portfolio technologies, starting with PortIO. Next slide. So a bit more about our updated strategy or revised strategy. As I mentioned, given the success of Lucid and Lucid’s ability to independently finance itself, we’ve decided to — moving forward to focus on driving shareholder value through our holdings in independently financed subsidiaries managed through our PAVmed shared services structure.

Following Lucid’s successful path of seeking — and we’ll seek financing opportunities directly to Veris and our subsidiaries based on the PAVmed — on the PMX incubator technologies as well as future subsidiaries. As I mentioned, Veris is shifting to large academic centers in order to drive — in order to enhance its financeability. The PMX launch has proceeded and the initial effort will be to independently finance PortIO as a subsidiary. We’re also actively seeking new ground-breaking independently financeable technologies and have several targets that we’re working on. These have large market opportunities that we’re — we’ve been agnostic to center and we’re looking to leverage PAVmed’s existing infrastructure. So a summary of the corporate structure as follows.

With PAVmed providing shared services. We have Lucid Diagnostics. We have Veris Health as our digital health platform. We have our medtech products within our privately held incubator, PMX. And we’re looking, again, to add additional assets consistent with the structure, each of them independently financiable. Just a couple of brief slides on Lucid. Again, I would recommend reviewing the further details in our webinar. As I mentioned in that slide, the — we had — we’ve stabilized our test volume, expected to remain in the 2,300 to 2,500 range, pending improvements in reimbursement as well as driving revenue through our early efforts at direct contracting. And you can see revenue has grown nicely since we took over and updated our revenue cycle management.

This is all in — out-of-network reimbursement. Next slide. And just a couple of highlights on Lucid on the commercial execution side. As I mentioned, we’re making great progress with our CYFT health fair testing events and are fully booked through July. We’re increasing our activity in strategic accounts and now have over a dozen. These are large academic medical centers and other regional centers. And on the revenue cycle management side, we’re getting about approximately 50% of our claims are now being allowed by commercial payers. And the payment amount has stabilized out of network at about $1,800. So it’s just shy — a bit shy of the Medicare price. Some of the key strategic accomplishments; we strengthened Lucid, strengthened its balance sheet by raising $18.1 million in the preferred stock financing.

I’ll note, again, to put it in the broader context of Lucid’s financeability. We’ve been gratified that Lucid has been able to raise its own capital and this financing puts that number well over $100 million, including the IPO. The clinical validity and clinical utility data now are well positioned to support a broad medical policy coverage for EsoGuard. They are positioning us to engage with the MolDx Group that works on local coverage determinations on behalf of Medicare. We’re looking for that reengagement to happen quite soon upon publication and peer review publication of one of the CV studies. We’ve just started in the last month or so to hold meetings with major commercial payers using our — using this data to formally request positive medical policy determinations and look forward to the outcomes of that.

As I mentioned, we’re really bullish on this direct contracting program where, with EsoGuard offered as a covered benefit and have expanded our team pursuing these. And we have a robust pipeline of employers, self-insured entities, working with brokers and third-party administrators, to offer EsoGuard in this fashion. Next slide. So a bit of an overview on Veris. Next slide. Veris Health is a commercial-stage digital health company that seeks to enhance personalized cancer care, has 2 components. The Veris Cancer Care platform which has a smartphone app that the patient interacts with and enters patient-reported outcome, information; along with a platform that the physicians and other caretakers use to track physiologic parameters that are collected currently using Bluetooth-connected external devices.

The long-term plan is to market an implantable monitor that works with this platform that would be inserted at the time of the implantation of a vascular access port for chemotherapy, immunotherapy. And the goal is to utilize modern remote patient monitoring tools to improve care through early detection of complications, longitudinal trends and risk management. Next slide. So a bit about our revised commercial strategy. Again, the goal here is to advance Veris to the point where it can raise its own independent capital. We’ve had strong interest in that regard. And we felt that the commercial strategy that targeted large, prestigious academic and regional cancer centers was the best path to get there. These tend to be centers that have large staff, a large number of oncologists and a large number of patients on infusion therapy, thousands and thousands of such of patients.

These tend to be concentrated in metropolitan areas. They are typically NCI-designated comprehensive cancer centers. And actually, many of them have venture arms. And in our conversations with them, we’ve had interest in the centers investing directly into Veris and that’s something we’re pursuing. So among these centers, we have a robust pipeline. We have over a dozen targets with multiple active discussions. And as I mentioned at the beginning, we have one engagement that in it’s very late stages and we expect it to consummate in the near term. Our approach with these is very different than with the smaller — as we initially approached the smaller oncology practices. And these are more comprehensive engagements, so they start with pilot programs and they involve long-term commercial partnerships as well as other strategic collaborations, so research and development activities, shared collaborations in this regard, that include developing care pathways, digital biomarkers and other innovations on our platform.

Next slide. So the Veris implantable monitor is an important future part of this endeavor. We think ultimately will play a central role in advancing this technology. Among other things, it assures a 100% compliance with — patient compliance to fulfill the requirements necessary for remote patient monitoring billing. Again, it’s designed to be implanted at the time of a vascular access port and provides many of the necessary physiologic parameters — relevant physiologic parameters you can see listed there continuously without the need for external devices. This device has gone through multiple — we’ve had multiple engagements with the FDA. We held our final and ultimately successful FDA presubmission meeting a few weeks ago. And now we believe we have a clear path to FDA clearance and commercial launch and we will push forward on that once Veris secures independent financing which we hope to accomplish soon.

Next, the final area that we announced recently is our new incubator, PMX. Next slide. So we launched PMX, as we announced last week, to complete development and commercialization of products — existing portfolio technologies which many long-term PAVmed shareholders will remember. The PortIO implantable intraosseous vascular access device; EsoCure esophageal ablation device which has been licensed to Lucid for commercialization once completed; the CarpX minimally invasive device for carpal tunnel syndrome. Each of these technologies have advanced quite far, with CarpX device having been cleared and was undergoing second-generation product development. These had been put on the back burner at the time of a restructuring about a year ago and we’re very excited to have launched these again in the context of this incubator through a joint venture with Hatch Medical, a very experienced group of medtech veterans who have long history of advancing medtech technologies as well as brokering partnerships and strategic acquisitions.

So we’re really looking forward to that. The structure is that we will seek to independently finance a separate subsidiary, the incubator, to develop and commercialize each technology. And our first target and we’re just getting started on seeking financing for this, is PortIO. It’s the first such device, the first implantable intraosseous vascular access device. It offers solutions for patients with poor veins or the need to preserve veins for dialysis and eliminates the need for regular maintenance with flushes and is resistant to occlusion and infections compared to traditional access devices. The estimated market opportunity, not including the dialysis population, is about $500 million. We completed the first in-human study in Colombia in 2022 and that study in nine patients demonstrated excellent device function, operated just as designed and there were no complications in any of those patients.

Using this data, we hope to add to extensive engagement we’ve had already with the FDA and we believe we now have a clear path to a U.S. IDE or investigational device exemption clinical study will be necessary to get a de novo regulatory clearance. So looking forward to getting this financed and moving forward to fulfill its commercial potential and then in series or in parallel, pursue similar pathways for EsoCure and CarpX. And with that, I’ll pass things over to Dennis to talk about our financial update.

Dennis McGrath: Thanks, Lishan. Our financial results for the fourth quarter and the year were reported in our press release that was published last night. On the next 3 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 in our annual report on Form 10-K that was filed with the SEC Monday afternoon and is available on the PAVmed website. So balance sheet, Slide 16 here. Cash of $19.6 million reflects sequential burn of $11.8 million. Cut our quarterly burn rate by 31% since the beginning of the year of 2023. These improvements are related to the cost control initiatives we put in place at the beginning of the year with continued improvement with each successive quarter.

Obviously, the cash balance does not reflect the $18.1 million in additional Lucid funding just 2 weeks ago. We disclosed in the 10-K that our ability to fund operations beyond 1 year from today is largely dependent upon how revenues ramp over the next 5 quarters which is highly dependent on how the reimbursement landscape for both government and private health insurers, as well as successful efforts for direct contracting with self-insured employer shapes, increases in payment realization of submitted claims and/or our corporate finance activities. The change in other assets is largely related to the normal amortization of certain intangibles, prepaid insurance as an example, the application of advanced vendor deposits to current period and current expenses.

With regard to the convertible note. The balance reflects a $37.7 million in face value principal plus $6.5 million in fair value accounting convention which is a noncash amount that gets added to that principal amount for accounting purposes. The face value principal is split between PAVmed and Lucid at approximately $27 million and $11 million, respectively. During the fourth quarter, the face value principal was reduced by about $1 million with the issuance of approximately 387,000 shares, post-split shares, of common shares. Other long-term liabilities are from capitalized leases related to our lab and office bases. Shares outstanding, including unvested restricted stock awards of 8.8 million. The GAAP outstanding shares of 8.6 million are reflected on the slide as well as the face of the balance sheet on the 10-K.

Slide 17. Slide 17 compares this year’s fourth quarter to last year’s fourth quarter and similarly for the yearly totals on certain key items. I trust you will review the information and my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information. Revenue for the fourth quarter largely reflects Lucid actual cash collections for the quarter for insurance, reimbursable claims, plus invoiced EsoGuard tests to the VA at about $26,000 to Ancira Auto Group under the direct contract. Testing there just got underway late in the fourth quarter. Plus some invoiced amounts, about $9,000, for Veris Cancer Care platform. As detailed in our Lucid quarterly call yesterday, recognized Lucid revenue of $1,040,000, represented a 33% increase over the third quarter and was in line with what was previously previewed to the market.

Test volume at 2,200 tests for the quarter represent just over $5 million in submitted claims for the fourth quarter at our standard ASP of $2,499. Lucid recognized revenue or its recognition policy. A key determinant is the probability of collection. And therefore, due to the fact that we are in the early stages of reimbursement process, means revenue recognition for claims submitted for traditional government or private health insurers will be recognized when the claim is actually collected versus when the patient report is invoiced and submitted for reimbursement. As you’ll see in our 10-K, this is called variable consideration, a jargon of GAAP’s ASC 606, the revenue recognition guidelines we need to live by. And presently, there is insufficient predictive data to reflect revenue when the test report is actually delivered.

For billable amounts contracted directly with employers that are fixed and determinable, there’s a difference in how we’ll recognize revenue. We will recognize that revenue when the contracted service is delivered. And the contracted service generally means when the report is delivered to the referring physician. Our non-GAAP loss for the year was $42 million with a quarterly average of $10.5 million and a quarterly high of $10.9 million. The fourth quarter non-GAAP loss was $10.6 million, very much in line with the average for the year. Slide 18. Slide 18 is a graphic illustration of our operating expenses presented in detail — as presented in detail in our press release. As detailed yesterday in our Lucid investor call, about $850,000 of the OpEx increase is related to certain onetime fourth quarter events, split about evenly between clinical research related to our published studies at that point, sales costs and patent expenses.

The balance related to Veris Health, particularly some animal studies to advance our work on the implantable. As also noteworthy of repeating, some reimbursement stats as mentioned on the Lucid call yesterday. Since the new revenue cycle manager, Quadax, took over in mid-June, about 7,800 claims representing almost $20 million in pro forma revenue, have been submitted for reimbursement. About 82% of those 7,800 claims have been adjudicated already which means 18% are still pending. Out of the 82% that have been adjudicated, about 46% resulted in an allowable amount by the insurance company with an average of $1,828 allowable per test. Of those denied, of which 54% were denied, about 51% of those that were denied fell into a couple of different buckets.

They either required additional information, that was about 7% of them; were deemed not medically necessary, that was 26%, that’s probably the most puzzling piece because the guidelines are well established, the patients meet those guidelines, they’re tested and we bill. So medically not necessary as a denial is one that’s ripe for appeal. Or last bucket, 18% of those denied require a prior authorization. About 29% were deemed not covered. And with that, operator, let’s open it up for questions.

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Q&A Session

Operator: [Operator Instructions] Your first question comes from Frank Takkinen with Lake Street Capital Markets.

Unidentified Analyst: This is Nelson [ph] on for Frank. I was wondering if you can provide some additional commentary on the biomarker legislation mentioned in yesterday’s call. What do the steps look like to obtain coverage with that? And how do you think about that opportunity impacting your business overall?

Lishan Aklog: Yes. Thanks for the opportunity to elaborate on that a little bit. It’s actually a really important and exciting area. As we mentioned, there are 15 states that have some type of biomarker legislation but they vary from state to state. So each one has a different flavor. The language is different. Generally, they seek to mandate coverage within the state by commercial payers for biomarker tests. Some of them are specific to cancer, some not. And so the opportunity there is great but it does require some work with regard to looking at each state one at a time and determining, in consultation with the commercial payers there, the language and making the case that we’re covered under that language. And so we’re still in the early stages of those engagements but we’re starting to get some traction there.

And we believe that we will, in many of them, if not ultimately all as we would hope, find — end up with a determination that EsoGuard, it is in fact which we believe it is, a biomarker test for cancer prevention that would be subject to mandatory coverage by payers in that state. So there are steps along the way, although the foundational language in these statutes are promising.

Unidentified Analyst: Got it. And then maybe switching over to Veris. How should we think about the potential revenue contribution from that in ’24 and ’25? I understand there’s a lot of moving pieces still but as you shift into those large academic and regional centers, how should we think about that?

Lishan Aklog: Yes. I’ll let Dennis maybe chime in a bit. But sort of conceptually and strategically, we’ve — we’re moving away. We still have some existing accounts with — that are oncology practices. But the cost of acquisition of these accounts was significantly higher, we needed a full sort of sales team to do that. While engaging with strategic accounts has longer lead times. They take more — there’s more time because as they’re named, the reason they’re called strategic accounts is because there’s a strategic dimension to these engagements. So they do have longer lead times but the commercial opportunity and the revenue opportunity in particular is higher. So, I would — I’ll let Dennis maybe chime in a little bit on sort of how we’re not really yet projecting.

But the larger — these are larger accounts, I think one of the accounts that we’re in the late stages of discussing has 10,000 patients with — getting infusion therapy. And so the revenue opportunity is substantial and it’s equivalent to dozens of smaller cancer oncology practices. The process for getting to being in a position where we would have some meaningful portion of those patients on the platform is not necessarily short. But often, we would expect to start with a pilot program in one particular area within that cancer center, for example, a higher-risk subgroup like bone-marrow transplants. And then work our way to a broader application. So why don’t I leave it there and see if Dennis has any further insights. I don’t think we’ll have a lot of color yet on a revenue trajectory but this is clearly, we believe, the path towards sustained value creation within Veris and financeability.

Dennis McGrath: Yes, maybe just a few other data points. So as Lishan indicated, these large strategic accounts have a large patient population. 10,000 was the number that Lishan put there. And if you think about the top 10 cancer centers in the United States, they’re all in that kind of framework of large patient pools. And as you’ll recall, this is a recurring revenue model for us. Reimbursement is not an issue. It’s already established. The general notion is that we would collect about $80 per patient per month for each patient that’s on the platform. Lishan already mentioned, our selling costs will be less because of just a single person getting a much larger opportunity. The transition will initially be pilot program, connected devices, ultimately higher penetration and adoption of the patient pool on the platform down the road, implantable devices as part of it.

These larger institutions tend to have a venture arm. Whether or not they — whether they participate in one that they influence decision-making, or they have one themselves, adds to the ability to finance this and become an anchor tenant, if you will, in a financing for this opportunity. So all of the piece parts make sense. The smaller cancer centers that we have started with have demonstrated the effectiveness of the platform, the completeness of it, the ability to monitor patients. So all of the validation side of the technology has now been accomplished with the smaller institutions we’ve been involved with. It’s now time to step up to these larger opportunities which give us a greater opportunity for scaling and scaling with the recurring revenue.

So, I think that’s what — over the next 2 years, you’ll see more of this. And how fast that speed will be in terms of adoption remains to be seen here but we are pretty optimistic about what could occur over the next several quarters for us.

Operator: Your next question comes from Ross Osborn with Cantor Fitzgerald.

Ross Osborn: So I understand the switch to larger centers but would be curious to hear, is the biopharma opportunity still interesting? Maybe in the post-market study space?