PAVmed Inc.

Good morning and welcome to the FABMED's 3rd Quarter 2024 Business Update Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press the star zero for the operator. Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, FABMED Director of Investor Relations. Please go ahead.

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. Alicia Macklog, Chairman and Chief Executive Officer of PABMED, along with Dennis McGrath, Chief Financial Officer of PABMED. The press release announcing our business update and financial results is available on PABMED'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 of the Securities and Exchange Commission. For a list and a description of these and other important risks and uncertainties that may affect future operations, Part 1, Item 1A, entitled Risk Factors and PAVMED's most recent annual report on Forms 10-K filed with the SEC and any subsequent updates filed in the QWERTY 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, foreign 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. Elishan Akhog, Chairman and CEO of PadMed. Take it away, Elishan.

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 PadMed. Over the last couple of quarters, we've taken several critical steps related to PadMed's corporate structure and balance sheet. This strategic transformation, which is now essentially complete, put PadMed in a strong position to fulfill its mission on behalf of its shareholders. As a result, PadMed 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 in the call. But the most important thing this step accomplished was to preserve PadMed'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? PadMed is now well-positioned to operate as a diversified commercial life sciences company with multiple independently-financed subsidiaries operating under a shared services model. Our portfolio includes Lucid Diagnostics, our publicly-traded diagnostics company, which, of course, remains PadMed's strongest asset. Varus Health is our digital health company, which offers a cancer case cancer care platform that enhances personalized cancer care. And our incubator, PMX, is advancing promising technologies in our portfolio, starting now with the Port IO implantable interosseous 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 PadMed 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 were happy to report record revenue in the third quarter. Our revenue increased 20% quarter-on-quarter. We published the ESAGARD 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 three productive meetings with the CMS Medicare Contractors, MOL-DX program, focused on this upcoming submission for e-cigarette coverage. Finally, as we recently announced, we've expanded our direct contracting initiative with multiple programs, including newly in the concierge medicine and expansion as an employer market side, to focus on driving near-term revenue. A lot of great developments with Ferris 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 various cancer care platforms, specifically for medically underserved patients, in partnership with an academic cancer center. We had initiated a capital raise. for VAERS, 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 TMX incubator side, we're continuing the process of seeking out direct financing to fund the Port IO device. With that, I'm going to hand the baton over to Dennis to give us our financial update.

Thanks, Lee Sean. Good morning, everyone. Summary financial results for the third quarter were reported in our press release that has been distributed. On the next four 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 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 PadMed. 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 PadMed to be on a more stable financial footing as I'll demonstrate two slides after this one. On October 29th in a formal hearing, we presented the NASDAQ a two-step plan to satisfy the continued listing for the NASDAQ's 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 30th. We were notified last Friday night that NASDAQ accepted that plan, which I'll describe in a moment, granting an extension through January 31st, 2025, to get the final step, which is subject to shareholder approval, being completed. Step one was to deconsolidate Lucid from PatMed, which, as you know, was accomplished on September 10th. The details are described in an 8-K file with the SEC in mid-September. are also more fully described in our PAVMED 10Q. But essentially, the deconsolidation requirement was accomplished by, first, changing board compositions such that 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 officer. PadMed 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 PadMed. 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. HAVMED and the convertible debt holder have agreed, subject to certain conditions, which 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 advisors 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 31st, 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 various cancer care platform and Port IO 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 VERUS. We have also circulated a VERUS 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 29th. Receiving NASDAQ's letter of approval last Friday was a key factor in now moving those funding efforts forward. Additionally, for Port IO, we've entered into a term sheet with an angel fund for a direct investment in Port IO 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 PABMED's balance sheet presentation. One, Lucid's cash is no longer consolidated in the presentation of PABMED's cash balance. However, equally important is that for the first time, PABMED'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 PABMED's presentation due to GAAP's intercompany consolidation rules. Furthermore, as Lucid's stock price rises, like it has since September 30th balance sheet date, this amount will increase. For instance, the balance in PABMED's related net equity has increased by more than 6 million from the balance sheet date of September 30th through earlier this week. HAVMED's standalone burn rate for the third quarter is about a break even once you strip Lucid out of the results. You'll see that illustrated as I address it further in two 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 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 PABNIT's financial control of LUCID. Importantly, The GAAP construct for deconsolidating Lucid on September 10th somewhat blurs the understanding of the information for PAVMED as a standalone entity, and GAAP does not allow the presentation for the prior periods to be similarly adjusted. The GAAP third quarter results as presented reflect inclusion or consolidation of Lucid's results for two and a third months, July 1st through September 10th. Indifferently for the two-thirds of the remainder of September, that is September 11th through September 30th, 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 PadMed'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 this slide in the Q&A, but I think it's more informative by pulling apart the deconsolidation chaos and illuminating what PABMED on a standalone 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 10Q. The three columns in the middle serve to explain or illustrate three critical steps. Column two, it isolates and takes out the $72 million gain purely from the deconsolidation effort. This is a result of identifying all of the Lucid balance sheet specific assets, their liabilities, their equity accounts, all embedded in the PABMED balance sheet on September 10th and taking them out of the PABMED totals. creates a net difference of $72 million and therefore the consequence gain that flows through the P&L. Obviously not a recurring item. Column three, deals with isolating Lucid's net P&L revenue and net operating expenses for the period July 1st through September 10th and then adjusting them out of the PABMED GAAP reported results. Column four, isolates the need to to include the full cash MSAC for July 1st through September 10th 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 five illustrates what the third quarter would look like on a standalone basis for the entire quarter on a pro form of presentation. Focusing on the bottom line, you can see a gap loss of about $1.6 million.

But after taking out the non-cash charges for depreciation and stock-based compensation and other non-gap adjustments, like the non-cash charges related to the debt, a break-even 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 in is equally related to A, the impact of the deconsolidation, and B, the fact that the combined operating expenses ignoring deconsolidation for both PABMED and Lucid would have been in line with previous quarters.

With that, operator, let's open it up for questions.

Thank you. And ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, seem to press the star followed by the number one on your cell phone keypad. If you're using a speaker phone, please pick up your handset before pressing any keys. To withdraw your question, please press the star two. Once again, please press the star one to join the queue. Your first question comes from the line of Ross Osborne with Cantor Pitstrival. Please go ahead.

Morning, Ross. Hey, guys. Thanks for taking our questions. Good morning. If maybe starting off, could you share any learnings from your work with Ohio State?

Sure, yeah. 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 a – we entered into a memorandum of understanding with the – this is the James Cancer Association. Center within Ohio State University Medical Center. It's the third largest cancer center in 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 VAERS platform and has actually now been extended for another 30 patients because one of the clinical sites 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, wildly 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 an escalating commercial engagement. So those are active discussions right now.