PAVmed - Q1 2024

Transcript

Operator (participant)

This call is being recorded on Tuesday, May 14, 2024. I would now like to turn the conference over to Matt Riley, Director of Investor Relations. Please go ahead.

Matt Riley (Director of Investor Relations)

Thank you, Operator. Good morning, everyone. 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, Chief Financial Officer of PAVmed. The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, press release, and the conference call all 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 Securities and Exchange Commission.

For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled "Risk Factors in PAVmed's Most Recent Annual Report on Forms 10-K Filed with the SEC, and Any Subsequent Updates Filed in Quarter Reports on Forms 10-Q and Subsequent Forms 8-K." 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 the expectations may be based or that may affect the likelihood the actual results will differ from those contained in the forward-looking statements. I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed. Lishan, you can take it away.

Lishan Aklog (Chairman and CEO)

Thank you, Matt, and good morning, everyone. Thank you for joining our PAVmed quarterly update call. Before proceeding, I'd like to thank our long-term shareholders for your ongoing support and commitment. We continue to leave no stone unturned to enhance long-term shareholder value. We continue to be pleased that Lucid, which is PAVmed's strongest and most advanced asset, is making such great commercial progress and continues to successfully finance its operations through long-term fundamental investors. Lucid has a runway to advance through key upcoming reimbursement milestones on its pathway to profitability. As we discussed during our last call, we have updated PAVmed's overall strategy to drive shareholder value through independently financed subsidiaries which, like Lucid, can leverage PAVmed's shared infrastructures. The initiatives we announced in furtherance of this strategy, specifically Veris's updated commercial strategy and the PMX Incubator, are progressing well. Let's begin with some highlights starting with Lucid.

As we noted in yesterday's Lucid quarterly update call, first-quarter EsoGuard revenue was flat quarterly. First-quarter test volume grew 10% quarter-over-quarter. Lucid further strengthened the EsoGuard clinical data evidence base, supporting ongoing engagement to secure commercial and Medicare payer coverage. Very importantly, a date for a MolDX pre-submission meeting was secured for July 17, 2024. On Veris Health, as I mentioned, we're executing on our new strategy, which is focusing on large academic cancer centers, and very excited that we were able to complete a memorandum of understanding with the Ohio State James Cancer Hospital to implement a pilot program enrolling their patients onto our Veris Cancer Care Platform. We have made solid progress on pursuing financing of Veris, and we have a clear path to FDA clearance of our implantable monitoring pending independent financing.

The PMX Incubator launched last quarter, and as we reported last time, it's a wholly owned incubator which we developed in partnership with Hatch Medical. Our first target is to raise capital for PortIO, and we've done so by creating a separate entity for PortIO as a wholly owned subsidiary of the incubator. Talk about that in more detail shortly. I pivoted out the strategy, and we'll refer to it again here and just summarize what PAVmed's strategy is. It's consistent with its overall vision but with some adjustments. Our strategy is to drive shareholder value through holdings and independently finance subsidiaries like Veris, Lucid, and PMX PortIO that are managed through a shared services structure that is held at the PAVmed level.

Our strategy is to follow the successful Lucid path and seek financing opportunities directly into Veris and the subsidiaries based on the PMX technologies and future subsidiaries. We're also actively seeking out new groundbreaking independently financeable technologies with large market opportunities that are agnostic of sector to leverage existing PAVmed infrastructure, and we hope to announce such a transaction in the not-too-distant future. The PAVmed corporate infrastructure is as shown here. PAVmed has the shared services infrastructure on behalf of its subsidiaries: Lucid Diagnostics, Veris Health, the PMX Incubator which houses now PortIO, and other technologies in the medical device space, and then potentially and hopefully other technologies that we can acquire a license and finance. So just a very brief couple of highlights on Lucid. I would encourage you to refer to the webinar from yesterday as well as the press release for further details.

As I mentioned in my opening, we're happy with the progress that Lucid has made on the EsoGuard front. You can see here on this slide that revenue was flat from quarter to quarter at about $1 million and test volume bumped up about 10%, and we are continuing our efforts with a fixed sales force to maintain our test volume in that approximate range and drive revenue growth through realization of revenue with our reimbursement strategies and our revenue cycle management. Two highlights that we discussed yesterday: we're making great progress with our CYFT events. We have 32 events. We now have a centralized telehealth operation. We have a very robust pipeline of direct contract engagements with various entities with whom we can contract directly and are looking forward to executing on those contracts in the coming quarters. Our revenue cycle management process and infrastructure continues to improve.

Dennis will talk about the numbers later, but a variety of improvements including proceeding with some prior authorization infrastructure on appeals, physician advocacy, and so forth, and we're happy that the out-of-network allowed amounts continue to average a robust $1,800. As we mentioned yesterday, strengthened our balance sheet completing just under $30 million of our Series B preferred offering. Two really important highlights from this past quarter: the peer-reviewed publication of positive data from the landmark National Cancer Institute-sponsored clinical validation study or the BETRNet study of EsoGuard, and the data really shows unprecedented results in early precancer detection. Based on the fact that we believe we now have sufficient data to move forward, we secured a July 17 meeting with the MolDX group to review our data for future submission of a technical assessment to seek coverage for EsoGuard under its foundational LCD.

On the market access side, there's a lot of activity across the board both with regional plans and national plans, but a big area of focus right now is to secure coverage, particularly from regional plans, in biomarker legislation states, and that's giving us good leverage to do so. Let's now move on to Veris. For those of you who are not familiar with the Veris story, Veris Health, PAVmed's subsidiary, is a commercial-stage digital health company which seeks to enhance personalized cancer care through digital tools including the Veris Cancer Care Platform which has a smartphone app for a cancer patient as well as a platform for the clinicians through which physiologic parameters are measured and sent to the physicians to enhance their care. We also have an implantable monitor that's under development that will provide ongoing physiologic data without the need for patient input.

The overall mission is to utilize these modern remote patient monitoring tools to improve care through early detection of complications, longitudinal trends, and risk management. As I previously noted, we updated our strategy for Veris to shift from cancer practices to large cancer centers including academic cancer centers, and we're really excited that we've had our first memorandum of understanding signed with the Ohio State University Comprehensive Cancer Center – James. This is an NCI-designated comprehensive cancer center. It's the third largest cancer hospital in the nation. They have over 10,000 patients per year who receive infusion therapy, which is the primary target for us, and we're looking forward to launching a pilot of the Veris Cancer Care Platform in approximately 100 patients. We expect this to launch imminently. We're actively raising capital triggered by the announcement of this engagement and look forward to consummating that soon.

We also remain engaged with numerous other strategic institutions, numerous other centers like the James. These are centers that have large staffs. Large number of patients on infusion therapy are typically concentrated in metropolitan areas. We focus on those that are also NCI-designated as comprehensive cancer centers, and many of these have venture arms as does the Ohio State University James. To mention a key part of our long-term vision with Veris is an implantable monitor that's intended to be implanted at the time of the vascular access port which provides continuous cardiac monitoring and also the relaying of additional data through Bluetooth connectivity to the platform, and we have made excellent progress on this. We have a clear path to FDA clearance and commercial launch, and we will proceed with that development and process towards FDA submission once we secure independent financing.

The implantable monitor is important for the long-term value of the platform because it assures 100% patient compliance with the RPM billing requirements. Finally, let's discuss the PMX Incubator which we announced last quarter. PMX is an incubator that was created in partnership with our colleagues at Hatch Medical, and the idea here is to take individual products that we had previously put on pause in 2023 and bring them into individual subsidiaries and raise individual capital for them to advance them to commercialization. Our first target is PortIO, and we've established a separate corporate entity as a subsidiary of the incubator, PortIO Corp, that is now actively raising capital to advance its project. Those of you who've been with PAVmed for a while know PortIO, but let me give you a deeper introduction for those of you who don't.

PortIO is the first implantable intraosseous, which means into the bone marrow, vascular access device that's designed for long-term use. It provides direct long-term access to the bone marrow, and it's analogous to long-term implantable vascular access ports as you can see on the bottom right there, the typical ports that patients with chemotherapy would get. The key feature, because it is inserted into the bone marrow, is that it's maintenance-free and therefore it has no costly or labor-intensive flushing requirements as do every other long-term vascular access port. We expect it'll have reduced complications including reduced infection rates relative to traditional venous access, and this addresses a very large unmet clinical need in a large diverse target population, particularly those who have patients who have poor veins and those in renal failure in whom their veins need to be preserved for future dialysis access.

We expect across the spectrum of the target population that the total addressable market is upwards of $3 billion. We have robust IP protection, and prior to putting the project on pause, we had completed our first-in-human study in Colombia, South America, and had excellent results with no complications and excellent function of the implantable port. We have a clear path to FDA. We've had a long engagement with them through the De Novo pathway following the completion of an IDE study. That study would begin upon submission of a final protocol to FDA once we have secured the financing to do so. The target margins for this technology is at least 85%, and we expect it to be reimbursed under existing codes for insertion of vascular access devices. With that, I'll pass the baton on to Dennis to give us a financial update.

Dennis McGrath (President and CFO)

Thanks, Lishan, and good morning, everyone.

Our summary financial results for the first quarter were reported in our press release that was published last night. 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 in our quarterly report on Form 10-Q. With regard to the balance sheet, cash at quarter-end March 31st was $25.5 million. We added $11.6 million to that amount with the Lucid financing completed last week for pro forma cash of $37.1 million. The average quarterly burn rate for the trailing four quarters is $11.7 million per quarter.

We disclose in the 10-Q that our ability to fund operations beyond one year from today is largely dependent upon how revenues ramp over the next four quarters, which is dependent upon how the reimbursement landscape for both government and private health insurers continues to improve for EsoGuard. Additionally, our direct contracting efforts with self-insured employers and/or corporate finance activities including refinancing any outstanding debt at the time can also work to exceed that threshold. Furthermore, as we advance the initiatives both with PMX Incubator and Veris Health, particularly in connection with the Ohio State University Cancer Care Center, any direct financing into either of these subsidiaries will further satisfy that threshold. The change in other assets is largely related to the normal amortization of certain tangibles, the prepaid insurance, the application of advanced vendor deposits to the current period incurred expenses. Convertible debt.

The convertible note, the balance reflects $37.3 million in face value principal plus $8.2 million in fair value accounting convention, a non-cash amount. The face value principal is split between PAVmed and Lucid at approximately $26.4 million and $10.9 million respectively. During the first quarter, face value principal was reduced by about $400,000 inclusive of the issuance of approximately 113,000 PAVmed common shares. Subsequent to quarter-end, an additional $280,000 of face value principal was paid inclusive of an additional 113,000 PAVmed common shares. Other long-term liabilities are from capitalized leases related to our lab and office spaces. Shares outstanding including unvested RSAs as of last week are $9.4 million. The GAAP outstanding shares of $8.9 million are reflected on the slide as well as the face of the balance sheet in the 10-Q. GAAP shares, they do not reflect unvested RSA amounts.

With regard to the P&L, this slide compares this year's first quarter to last year's first quarter and certain key items. I trust you'll review the information, my comments in light of the cautionary disclosure on the bottom of the slide about supplemental information, particularly non-GAAP information. Revenue for the first quarter largely reflects Lucid actual cash collections for the quarter for insurance reimbursable claims plus invoiced EsoGuard tests to the VA and about $25,000 in direct contracting plus invoiced amounts, about $9,000, for the Veris Cancer Care Platform. As detailed in our Lucid quarterly call yesterday, recognized Lucid revenue just over $1 million is sequentially about even with the fourth quarter and reflects more than a twofold increase over the prior year first quarter and is in line with what was previously previewed.

Test volume at 2,420 tests for the quarter represents just over $6 million in submitted claims for the first quarter at our $2,499 ASP. Lucid revenue recognition, a key determinant, is the probability of collection. Therefore, due to the fact that we're in the early stages of the reimbursement process, it means revenue recognition for claims submitted to 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-Q, this is called variable consideration, the jargon of GAAP's ASC 606 revenue recognition guidelines, and presently, there's insufficient predictive data to reflect revenue when the test report is delivered to the referring physician. That will occur in time.

For billable amounts contracted directly with employers and that are fixed and determinable will be recognized as revenue when the contracted service is delivered. Generally, that means when the report is delivered to the referring physician. Our non-GAAP loss for the first quarter of $8.6 million reflects about a $2 million sequential improvement compared to the fourth quarter loss and about a $2.5 million improvement year-over-year from that prior year quarter. With regard to the non-GAAP operating expenses on this slide, you'll see a graphic illustration of our operating expenses over time as presented and in detail in our press release. Total non-GAAP operating expense is $12.6 million for the first quarter of 2024 and reflects a $2.2 million improvement sequentially and $2.4 million improvement year-over-year.

Clinical research costs are the primary driver for the first quarter reduction amounting to approximately $1.7 million of the reduced spend since the fourth quarter. The non-GAAP loss per share for the first quarter was $0.99 per share. On a GAAP EPS basis, non-cash charges accounted for approximately $1.63 per share in the first quarter, of which $0.86 was directly related to the non-cash deemed dividend connected to the March financing of $18.2 million, and $0.52 per share was related to the convertible debt charges. Also worthy of repeating are some reimbursement stats as mentioned on the Lucid call yesterday, focusing the reimbursement stats for the last two quarters, the first quarter and the fourth quarter of last year. 3,975 claims, just under 4,000 claims, representing just under $10 million in pro forma revenue have been submitted for reimbursement. About 75% have been adjudicated, 25% are pending.

Lishan Aklog (Chairman and CEO)

Out of the 75% that have been adjudicated, about 46%, just about half, resulted in an allowable amount by the insurance company with a mean average of about $1,700 per test and with a longer aging time, the 6-month horizon with appeals, approximately $1,800 per test. Of those denied, about 53% are deemed not medically necessary or require a prior authorization. About 28% were deemed to be non-covered. So with that, operator, let's open it up for questions.

Operator (participant)

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by number one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by number two. If you are using a speakerphone, please leave the handset before pressing any keys.

One moment, please, for your first question. Your first question comes from the line of Anthony Vendetti from Maxim Group. Your line is now open. Please ask your question.

Lishan Aklog (Chairman and CEO)

Good morning, Anthony.

Dennis McGrath (President and CFO)

Hi, Anthony.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

Good morning, Dennis. Good morning, Lishan. Yeah, just on the memorandum of understanding with Ohio State, what are the milestones or expectations for that to go to some type of definitive agreement? And then how many others like Ohio State do you have in the pipeline at this point? Thank you.

Lishan Aklog (Chairman and CEO)

Yeah, great question. So let me just backtrack a little bit chronologically. So we've had really fruitful discussions with the full team at Ohio State. There's a real strong shared vision for the role of digital health tools in advancing cancer care that go, frankly, beyond the initial efforts within remote patient monitoring. Lots of discussions around long-term goals and opportunities to collaborate beyond this.

This memorandum of understanding focuses on a pilot study that we expect to launch in the coming weeks, and it will involve up to 100 patients in 2 units within the medical center. The goals really for the pilot are to really demonstrate feasibility, to demonstrate the key elements of this platform, which is getting patients on the platform, getting them connected to the monitoring tools through Bluetooth, making sure that the data is making it to the physicians and the other caretakers, and it's able to provide the information to impact cancer care. We look forward, following that, upon completion of an RFP that's currently active, to hopefully expand that beyond to a full engagement on the commercial side.

So the answer is really that the pilot is intended to just demonstrate feasibility, but our goal is to advance the partnership to cover an increasing number of the patients within the platform and then ultimately to work collaboratively on innovation in this space, which, again, is something that was really the centerpiece of our conversations with them and effort to engage. We have about a half a dozen other large centers that we have active conversations with, several of whom are advancing to more fulsome conversations. I think as we described, we're operating under a strategy where Veris is raising capital in order to expand its efforts beyond the initial sites. So we expect to advance these individual centers after demonstrating feasibility here and being able to raise capital in order to advance beyond that.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

Okay, thanks a lot. I will appreciate the call. I'll hop back in the queue. Thank you.

Lishan Aklog (Chairman and CEO)

Thanks, Anthony.

Operator (participant)

Your next question comes from the line of Frank Takkinen from Lake Street Capital Markets. Your line is now open. Please ask your question.

Lishan Aklog (Chairman and CEO)

Frank, good morning.

Dennis McGrath (President and CFO)

Great. Can you take the question?

Frank Takkinen (Senior Research Analyst)

Good morning. Good morning. Just one more follow-up on the Ohio State MOU. Maybe walk us through what the total revenue opportunity looks like. I understand you're going into a pilot, but how large is their cancer center? And if you were to be successful in that pilot and you rolled it out across that entire network through Ohio State, what kind of revenue opportunity could that look like? And then as a second part to that question, how should we think about how many players are out there similar to Ohio State that you could partner with?

Lishan Aklog (Chairman and CEO)

Yeah, I'll answer that at a high level.

Let me sort of start from the latter and maybe work more specifically. So a significant portion of cancer care, particularly the kinds of patients who we're targeting with the Veris Cancer Care Platform, which are those that are diagnosed with and are entering what's called systemic therapy, which usually means infusion therapy. We do have the vision to go beyond that, but that's the initial target. So a reasonable portion of those patients across the country are cared for at large comprehensive cancer centers such as Ohio State, the Ohio State James Hospital. They, as I mentioned, have 10,000 patients who are in infusion therapy. And so when this hopefully transitions from this pilot program into a full program, we'll have the opportunity to expand the engagement to include an increasing proportion of those patients.

Stepping back, as we've talked before, not specific to Ohio State, but with regard to the platform as it's designed now, we have the remote patient monitoring billing opportunities for an individual center are such that our recurring revenue service model that we provide provides an opportunity with approximately $1,000-$1,200 per patient per year. And so I think I'll leave it at I mean, I think I'll leave it at that high level for now, Frank. The revenue opportunity is substantial. These large centers, this is why we transitioned from smaller practices to large centers because, frankly, it's a more efficient engagement. It's got a bit of additional lead time and additional work to get there. But the strategic opportunities, as well as the size of these centers in terms of the number of patients and the subsequent revenue opportunity, are substantially greater.

And we're really happy with that transition, and we look forward to completing this pilot and transitioning to a commercial relationship that can yield substantially more patients on the platform and ultimately increasing revenue opportunities.

Frank Takkinen (Senior Research Analyst)

Got it. And then the second half of that, how should we think about the opportunity of players like this? Or maybe more specifically, how should we think about your current funnel of opportunities like this?

Lishan Aklog (Chairman and CEO)

Yeah. So as I said, we have several dozen, actually, on our target list. We have approximately five that we have engagements with, of which Ohio State is one of the largest. It's the third largest in the country.

And the pace at which we're not really in a position yet to say what the pace will be in terms of signing these up, a lot of it will depend on the success of this pilot as well as our ability to raise sufficient capital to expand our commercial activity to multiple sites concurrently.

Frank Takkinen (Senior Research Analyst)

Perfect. And then just last one for me. I think you referenced it briefly in your prepared comments. A lot of these centers have venture arms. How could some sort of strategic investment from them be structured and look like?

Lishan Aklog (Chairman and CEO)

Yeah, we've had in prior engagements, beyond Veris, with academic centers. And you're right to highlight the fact that many large academic centers, not just in the cancer sector, have venture arms and have interest in engaging in investment opportunities alongside the strategic collaborations, right?

Especially since this is one of the great parts of transitioning our strategy to larger academic centers, is that there's a greater opportunity for these kinds of strategic collaboration, which include opportunities to develop actually new products or new care platforms that have licensing opportunities and so forth. So that does provide an initiative to partner not simply on the clinical side but also on the venture side. Each institution has different structures and strategies for their investment, but I think generically, they share a common theme, which is to simply invest in the entity through these arms as a sort of a measure of a sort of a vote of confidence in the commercial potential of the partner as well as the partnership. And so they all vary, but at the end of the day, they're just simply venture investments typically into the company.

We certainly are seeking those with the partners that we are targeting here.

Frank Takkinen (Senior Research Analyst)

Perfect. Good color. Thanks for all that, and congrats on all the progress.

Lishan Aklog (Chairman and CEO)

Great. Thanks, Frank. Thanks, Frank.

Operator (participant)

Once again, ladies and gentlemen, if you want to ask a question, please press star followed by number one on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by number two. If you are using a speakerphone, please leave the handset before pressing any keys. One moment, please, for your next question. Your next question comes from the line of Edward from Ascendiant Capital. Your line is now open. Please ask your question.

Lishan Aklog (Chairman and CEO)

Good morning, Ed.

Edward Woo (Director of Research and Senior Analyst)

Yeah, congratulations on all the progress. My question is on PortIO and the PMX incubator initiatives.

Can you talk about the fundraising environment, how difficult it is or how easy it is to raise money? And also, is there a strategy to focus on PortIO versus EsoCure and CarpX at the same time, or to do it kind of on a linear process?

Lishan Aklog (Chairman and CEO)

Yeah. So it's interesting. It's always raising capital is never easy, but what's interesting in our engagement with Hatch is that they have a somewhat different universe based on their 30 years of experience of engaging with pockets of investors, particularly on the angel side, that are anxious to invest in assets like this at the bite size, at the investment size that we need to advance these products, which is not all that great. So we're very active, and the process is off to a great start.

And we really are actually quite optimistic that we'll be able to raise the capital individually into PortIO through the partnership with the folks at Hatch who have great experience in doing so. So that's promising, and we look forward to consummating that and getting started. As it relates to the other products that we've put into the incubator, EsoCure and CarpX, and potentially others, what we're pursuing is raising capital one at a time, but certainly not waiting to complete the project or advancing into commercialization one at a time. So they'll be staggered but in parallel. So once we're able to raise sufficient funds to fund PortIO through commercialization, FDA submission and sorry, FDA submission and clearance and commercialization, once we've raised those funds, we will move on to the next target, which would likely be EsoCure and then subsequently CarpX.

So ideally, as we continue to raise capital into each of these projects, that in the not-too-distant future, they will all be moving along their path towards commercialization in parallel. Great. Thanks for answering my question, and I wish you guys good luck.

Edward Woo (Director of Research and Senior Analyst)

Thank you.

Lishan Aklog (Chairman and CEO)

Yep. Thanks, Ed.

Dennis McGrath (President and CFO)

Thanks, Ed.

Operator (participant)

We do not have any further questions at this time. I would now like to turn the conference back to Lishan Aklog.

Lishan Aklog (Chairman and CEO)

Great. So hey, thank you all for joining today. And as always, thanks for all the great questions and great discussion. Hopefully, you have a sense that we're really excited. We're still in the early phases of executing on this updated PAVmed strategy that we hope, in addition to the activities and successes we're having at Lucid, will translate into other subsidiaries, including Veris and PMX and potentially, hopefully, others that we consummate in the near future.

So as always, we look forward to keeping you abreast of our progress via press releases and conference calls such as this one. To keep up with PAVmed, Lucid, Veris updates, I would encourage you to sign up for our email alerts at both the PAVmed and Lucid investor relation sites to follow us on social media, on Twitter, on LinkedIn, and to contact Matt with any specific questions. So thank you very much, everybody, and have a great day.

Operator (participant)

This concludes today's conference call. Thank you for your participation. You may now disconnect. Happy Tuesday, everyone.