Lishan Aklog; Chairman of the Board, Chief Executive Officer; PAVmed Inc
Dennis Mcgrath; President, Chief Financial Officer; PAVmed Inc
Ross Osborn; Analyst; Cantor Fitzgerald
Anthony Vendetti; Analyst; Anthony Vendetti
Edward Woo; Analyst; Ascendiant Capital
Presentation
Operator
Good morning, and welcome to the PAVmed's third-quarter 2024 business update conference call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, PAVmed Director of Investor Relations. Please go ahead.
Matt Riley
Thank you, operator, and 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 the 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 I, Item IA entitled Risk Factors in PAVmed's most recent annual report on Forms 10-K filed with the SEC and any subsequent updates filed in the quarterly 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 that 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. Take it away, Lishan.
Lishan Aklog
Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment. . Before we delve into our recent operational highlights, I'd like to make a few high-level points. This has been a transformational quarter for PAVmed. Over the last couple of quarters, we've taken several critical steps related to PAVmed's corporate structure and balance sheet. This strategic transformation, which is now essentially complete, put PAVmed in the strong position to fulfill its mission on behalf of its shareholders. As a result, PAVmed is now a sustainable vehicle that's capable of doing precisely what it was designed to do, deliver innovative medical technologies that address unmet clinical needs. The first step was the recent deconsolidation of Lucid Diagnostics, Dennis will provide greater context on this later on the call. But the most important thing this step accomplished was to preserve PAVmed's ownership in Lucid without having to absorb Lucid's operating losses on its balance sheet. The second step, which again, Dennis will provide further details on later, was the restructuring of our convertible debt, which will allow us to preserve our Nasdaq listing. So where are we now? PAVmed is now well positioned to operate as a diversified commercial life sciences company with multiple independently financed subsidiary operating under a shared services model. Our portfolio includes Lucid Diagnostics, our publicly traded diagnostics company, which, of course, remains PAVmed's strongest asset. Veris Health is our digital health company, which offers a Cancer Care Platform that enhances personalized cancer care. And our incubator, PMX is advancing promising technologies in our portfolio, starting now with the PortIO, implantable intraosseous device. Our shared services model allows us the flexibility to bring in new assets and technologies in our portfolio, which we continue to actively pursue. With this strategic transformation, I really couldn't be more excited about the future of PAVmed and its subsidiaries. So let's go on to highlights from the third quarter and recent weeks. Let's start with Lucid Diagnostics. First, let me encourage you to listen to yesterday's Lucid business update call for greater details. We are happy to report record revenue in the third quarter. Our revenue increased 20% quarter-on-quarter. We published the ESOGUARD BE-1 clinical validation study, which is accepted for peer review publication, and that is the final piece that now completes our clinical evidence package for us to formally submit seeking Medicare coverage. We've held 3 productive meetings with the CMS Medicare contractors, MolDX program, focused on this upcoming submission for EsoGuard coverage. Finally, as we recently announced, we've expanded our direct contracting initiative with multiple programs, including newly in the concierge medicine and expansion of the employer market side to focus on driving near-term revenue. A lot of great developments with Veris Health, our pilot with The Ohio State University, The James Cancer Center, is now complete, and we are in active discussions with the institution on long-term commercial and strategic partnerships. We are happy to have received a $1.8 million NIH grant, which will allow us to further optimize the Veris Cancer Care Platform, specifically for our medically underserved patients in partnership with an academic cancer center. We had initiated a capital raise for Veris, but put that on hold during the restructuring process and are looking forward to reinitiating that shortly. We're also preparing to relaunch the development of the implantable monitor. On the PMX incubator side, we're continuing the process of seeking our direct financing to fund the PortIO device. With that, I'm going to hand the baton over to Dennis to give us our financial update.
Dennis Mcgrath
Thanks, Lishan, and good morning, everyone. The summary of financial results for the third quarter were reported in our press release that has been distributed. On the next 4 slides, I'll emphasize on 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 as filed with the SEC. With regard to the balance sheet, as you can see from the slide, things look very different comparing the third quarter to the previous quarter as a result of the deconsolidation of Lucid from PAVmed. That comment will also hold true for the P&L once I get there as well. Before I dive into the details explaining financial results for the third quarter, it's best to provide some insight as to the master plan and the intentional steps that management and the Board have taken and are continuing to take to both maintain the Nasdaq listing and also move PAVmed to be on a more stable financial footing as I'll demonstrate 2 slides after this one. On October 29, in a formal hearing we presented the Nasdaq a 2-step plan to satisfy the continued listing for the Nasdaq capital market and therefore, maintain our Nasdaq listing for at least the next 12 months. Structures in place that we believe may allow us to sustain compliance for much longer. The minimum requirement that we had to demonstrate to Nasdaq was that the company could achieve GAAP stockholders' equity greater than $2.5 million and be able to sustain that minimum for more than 12 months. Our starting point was a deficit of $18.6 million as of June 30. We were notified last Friday night that Nasdaq accepted that plan, which I'll describe in a moment, granting an extension through January 31, 2025, to get the final step, which is subject to shareholder approval being completed. Step one was to deconsolidate Lucid from PAVmed, which, as you know, was accomplished on September 10. The details are described in the 8-K filed with the SEC in mid-September are also more fully described in our PAVmed 10-Q. But essentially, the deconsolidation requirement was accomplished by first, changing Board compositions such as the majority of the members of the Lucid Board were no longer also PAVmed directors. And secondly, eliminating a few voting proxies that certain shareholders had granted over their Lucid shares in favor of the PAVmed office. PAVmed continues to be the single largest shareholder of the common stock. However, the controlling voting interest dropped from more than 50% to about 40% as a result of these intentional actions by management and the Board, clearing the pathway to deconsolidate Lucid from PAVmed. This action alone cut the third quarter shareholder deficit in half from the previous quarter's balance. The 10-Q footnote number four to the financial statements provides a lot more detail on this impact. Step two, required restructuring the convertible debt. PAVmed and the convertible debt holder have agreed, subject to certain conditions, that I'll get into in a moment, to exchange $25 million of existing obligations for newly created Series [ C ] convertible preferred stock of an equivalent value. Thereby not only wiping out the deficit, but also allowing us to demonstrate the Nasdaq a plan for sustainable compliance with the continued listing standard for a meaningful period of time. The effective date of the exchange is subject to a few conditions. First, before the exchange agreement will become effective, our accounting advisers need to complete their final quality review steps of their independent analysis to concur with our internal assessment that after the debt for preferred exchange is completed, the preferred stock will be classified as GAAP permanent equity. The company hired BDO to complete an independent analysis with regard to the likely permanent equity classification. That analysis is being reviewed by our auditors. We are awaiting the completion of that review, which is expected shortly. Upon satisfactory completion of that review and an affirmative conclusion about the likelihood of permanent equity classification, the exchange agreement will become effective. Second, we have agreed with our debt holder that the consummation of the exchange is subject to shareholder approval of certain customary measures that would allow for the full conversion of the Series C preferred stock. We expect to file a shareholder proxy shortly for a special meeting of the shareholders to request approval of these measures and shortly thereafter close the exchange, well in advance of the January 31, 2025, extended deadline for regaining compliance with Nasdaq. Additional tactical steps being taken by management and the Board. The incurrence of future R&D expenses to advance the next development stages of the Veris Cancer Care Platform and PortIO technology will be largely dependent upon obtaining direct funding into those entities to cover the incremental development costs. Hence, any increased burn from those endeavors will be offset by the incremental financing. As a good start in that direction, we previously announced being awarded a National Institute of Health grant of $1.8 million from Veris. We have also circulated a Veris offering memorandum at a $35 million pre-money valuation and received an indication of interest to fund the first tranche for the implantable devices next steps. This funding effort has been paused pending the outcome of the hearings panel meeting on October 29. Receiving Nasdaq's letter of approval last Friday was a key factor now moving those funding efforts forward. Additionally, for PortIO, we've entered into a term sheet with an angel fund for a direct investment in PortIO Corp at a pre-money valuation of $42 million to cover the final development steps. The angel fund is in the process of conducting its diligence with our team. So now for the comparative analysis. Two immediate things to notice on PAVmed's balance sheet presentation. One, Lucid's cash is no longer consolidated in the presentation of PAVmed's cash balance. However, equally important is that for the first time, PAVmed's balance sheet presents the inclusion of the $25.5 million market value of its 31.3 million Lucid share ownership. Previously, that inclusion was eliminated out of PAVmed's presentation due to [ GAAP's ] intercompany consolidation rules. Furthermore, as Lucid's stock price rises, like it has since September 30 balance sheet date, this amount will increase. For instance, the balance and PAVmed-related net equity has increased by more than $6 million from the balance sheet date of September 30 through earlier this week. PAVmed stand-alone burn rate for the third quarter is about a breakeven once you strip lose it out of the results. You'll see that illustrate it as I address it further in 2 slides from now. Finishing this slide. The change in other assets is largely related to the Lucid deconsolidation. The amount of convertible notes reflects deconsolidating Lucid's convertible note from the prior balance and before the effect of the proposed $25 million exchange into preferred, which will happen after the shareholder vote. Shares outstanding, including unvested restricted stock awards, $11 million. The GAAP outstanding shares of 10.7 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP sequential quarterly comparisons as well as year-over-year information. However, there are some significant differences in how the information is compiled between the comparative periods given the changes in PAVmed's financial control of Lucid. Importantly, the GAAP construct for deconsolidating Lucid on September 10, somewhat blurs the understanding of the information for PAVmed as a stand-alone entity and GAAP does not allow the presentation for the prior periods to be similarly adjusted. The GAAP third quarter results is presented, reflecting inclusion or consolidation of Lucid's results for 2 and one-third months, July 1 through September 10. And differently, for the two-thirds of the remainder of September, that is September 11 through September 30 because Lucid's results are not included. Furthermore, you can see a large net income of $61 million on the GAAP P&L. This is before the non-controlling interest. And positive primary EPS of $6.43 per share and a positive diluted EPS of $1.44 per share. This is all the result of eliminating Lucid from PAVmed's balance sheet and extracting the impact of Lucid's cumulative historical losses. The net adjustments to the balance sheet create a $72 million gain that then flows through the P&L to obtain the net equity impact of all of the deconsolidation adjustments. Happy to answer any detailed questions on the slide in the Q&A. But I think it's more informative by pulling apart the deconsolidation chaos and illuminating what PAVmed on a stand-alone basis looks like. That's what I hope to achieve on this next slide. Next slide, please. I trust you'll review this information on this pro forma presentation and my comments in light of the cautionary disclosure on the bottom of the previous slide about supplemental information, particularly the non-GAAP information that's presented. The first column on this slide provides an exact snapshot of the statement of operations directly from the 10-Q. The three columns in the middle serve to explain or illustrate three critical steps. Column 2, it isolates and takes out the $72 million gain purely from the deconsolidation effort. This is a result of identifying all of the Lucid's balance sheet-specific assets, their liabilities, their equity counts, all bedded in the PAVmed balance sheet on September 10 and taking them out of the PAVmed totals, creates a net difference of $72 million, and therefore, the consequent gain that flows through the P&L, obviously, not a recurring item. Column 3 deals with isolating Lucid's net P&L revenue and net operating expenses for the period July 1 through September 10 and then adjusting them out of the PAVmed's GAAP reported results. Column 4 isolates the need to include the full cash MSA fee for July 1 through September 10 and that had been eliminated for the period of time that Lucid's results were consolidated into the GAAP P&L because of intercompany-related parting GAAP rules. Column 5 illustrates what the third quarter would look like on a stand-alone basis for the entire quarter on a pro forma presentation. Focusing on the bottom line, you can see a GAAP loss of about $1.6 million, but after taking out the noncash charges for depreciation and stock-based compensation, and other non-GAAP adjustments like the non-cash charges related to the debt results in a small profit, essentially a breakeven scenario. Next slide, please. With regard to non-GAAP operating expenses. On this slide, you'll see a graphic illustration of our operating expenses over time as presented in detail in our press release. Total non-GAAP operating expense is $10.1 million for the third quarter of '24. The decrease is equally related to: a, the impact of the deconsolidation; and b, the fact that the combined operating expenses, ignoring deconsolidation for both PAVmed and Lucid would have been in line with previous quarters. With that, operator, let's open it up for questions.
Question and Answer Session
Operator
(Operator Instructions) Ross Osborn, Cantor Fitzgerald.
Ross Osborn
Maybe starting off, could you share any learnings from your work with The Ohio State?
Lishan Aklog
Sure. Yes. So just to catch folks up, we've had a really strong engagement with them now coming on, I think, probably about a year since we initially engaged with them. And we launched -- we entered into a memorandum of understanding with the -- this is The James Cancer Center within Ohio State University Medical Center. It's the third largest cancer center of the country and an NCI-designated comprehensive cancer center. We entered into a memorandum of understanding with them earlier this year that called for a first step of a pilot program with the institution that ran through the summer. It enrolled 100 patients on the Veris platform and has actually now been extended for another 30 patients because one of the clinical sites was -- that wasn't a participant in the initial pilot, was honestly clamoring to be a part of it. The pilot was highly structured. It had KPIs of metrics with regard to patient, physician satisfaction and other key parameters and that's been completed and was, frankly, widely successful with great feedback from all corners of the institution, from the administration to the leadership. So we're now in the process of having discussions with the leadership to follow up on other aspects of the -- that were articulated in the Memorandum of understanding, which would sort of fall under the broad umbrella of a strategic partnership with escalating commercial engagement. So those are active discussions right now. There's a lot of activity with -- between the -- between us and the institution at telling the story of their experience with this pilot and how the various platform is able to enhance and personalize the care of those cancer patients. And this engagement, our goal is for this to serve as a template as we enter into similar discussions with a pipeline of some of our academic cancer centers around the country.
Ross Osborn
Okay. Great. And then I guess maybe regarding OpEx for PAVmed. How should we think about that in the coming quarters? I'm assuming maybe pretty steady ahead of any incremental financing?
Dennis Mcgrath
Yes. So as we presented in that pro forma slide, you can see the kind of the normalized OpEx moving forward. That's our baseline. As we generate the direct financing either in Veris or in PortIO, that will be the gating factor to now incur the additional operating expenses. In Veris' case, moving it towards the implantable. That's probably a couple of million dollar efforts over a 6- to 8-month period of time. And likewise, in PortIO, with the financing, it's probably about a $4 million expenditure probably over a 12-month period of time. And it is those aspects of change in funding that will drive where the OpEx goes. But otherwise, the pro forma that's illustrated on that slide is the baseline and should continue going forward. is a likely representation of the fourth quarter and with the funding, the changes that may occur in 2025.
Operator
Anthony Vendetti, Maxim Group.
Anthony Vendetti
Just a little more follow-up on the Veris program. So assuming you get the financing and so forth, is it still on track for submission with the FDA on a 510(k) basis before the first half of '25?
Lishan Aklog
I think it may -- we've -- because of the delay in closing the financing, which was necessary as a result of the restructuring and just sort of wrapping up the efforts to fix the listing requirement, it may leak into the early half of the second half, but hopefully not by much.
Anthony Vendetti
Okay. Great. And then in terms of the financing for the PMX incubator, you said you have lined up some financing already. How much total funding.....
Lishan Aklog
Let me clarify that. So we've engaged with an angel network that -- and we have a turf sheet in place, and Dennis explained the terms of that, which are attractive to raise $4 million, which covers the expenses of the second-generation PortIO as well as completing the [ IDE ] clinical trial to commercialization. That was at a $42 million pre-money valuation. So that term sheet has been finalized and negotiated. We are at the very end, they have a very rigorous diligence process, and we're at the very end of that process. And we expect the diligence report to be wrapped up soon. And then the network will go to its individual members and start circulating the opportunity and start raising the cash over the -- and collecting subscription agreements over the -- in the near term.
Operator
Ed Woo, Ascendiant Capital.
Edward Woo
Yes. Congratulations on all your progress. My question is on The Ohio State pilot. What does the competitive slate looks like? Were you guys competing against other diagnostic, remote diagnostic devices? Or did they have nothing before that?
Lishan Aklog
So the cancer center has not engaged with a digital health platform specific for cancer. I believe there are other products more that are being used broadly and they're actually in the process of trying to figure out what generalized remote patient monitoring platform they're going to use for the broader institution. But my understanding is this is the first foray of the cancer center, which is our direct partner in the digital health care platform arena. And certainly, our -- during the pilot, we were the only product that they were utilizing.
Operator
There are no further questions at this time. I would like to turn it back to Dr. Lishan Aklog for closing remarks.
Lishan Aklog
So great. Thank you, operator, and thank you all for joining today. I hope you leave today with a strong sense that PAVmed has taken the decisive steps that it needed to, to solidify and stabilize our corporate structure and strengthen our balance sheet. We really do look forward to a bright future, positioning PAVmed as a sustainable, diversified commercial life sciences company with multiply independently financed subsidiaries. I do encourage you to stay connected with our progress through our news releases, periodic calls such as this and signing up for e-mail alerts on our IR website, and you can also follow us on Twitter and LinkedIn. So again, thank you for your continued support. And as they say, watch this space. Have a great day.
Operator
Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.
