Earnings Call Transcript - PAVM Q1 2026

Operator, Operator

Good morning, and welcome to the PAVmed First Quarter 2026 Business Update Conference Call. Please note, this event is being recorded. I would now like to turn the conference call over to Matt Riley, PAVmed's Vice President of Investor Relations. Please go ahead.

Matthew Riley, Vice President, Investor Relations

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 disclaimer about forward-looking statements in the press release. The business update press release and 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 SEC. 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 Form 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 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 turn the call over to Dr. Lishan Aklog, Chairman and CEO of PAVmed.

Lishan Aklog, Chairman and Chief Executive Officer

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call today. At our last business update call, we discussed the two-year process we undertook to permanently fix a legacy capital structure and strengthen the balance sheet. The final step has been completed in the last couple of weeks and the cap table is now clean. Dennis will discuss this in more depth, but the cap table now consists of common stock and warrants. With that, we now truly believe that PAVmed is well positioned to execute on its founding mission: to operate as a high-growth, diversified commercial life sciences company with multiple independently financed subsidiaries operating under our shared services model, and that we are well positioned to evaluate new opportunities as they come along. I'll talk a little bit about how that has accelerated since the restructuring took place. As we described on our last call, part of one major initiative that followed this restructuring has been the relaunching of our medical device portfolio under Virgilio. He's been on board now and has hit the ground running. He is actively focusing on advancing multiple medical device opportunities, including PortIO and the endoscopic imaging technology we licensed from Duke under the Actaris umbrella, as well as broader responsibilities across our entire medical device portfolio, utilizing his expertise in building and scaling businesses and raising capital for these individual medical device initiatives. As I mentioned, the pipeline has definitely opened up. We are evaluating business development assets that are being brought forth to us. We're on our second major diligence exercise. We did pass on the first opportunity, as attractive as it was. We really do expect those to bear fruit for us in bringing commercial assets into our portfolio. So now let's move on to Lucid Diagnostics. Lucid is on the cusp of transformative milestones, including what we believe is pending Medicare coverage. As we discussed on our previous call, we're waiting on Medicare; it's been a bit frustrating that this has dragged on but our confidence has not wavered. I encourage you to listen to yesterday's Lucid business update call for greater details on this and other aspects of the business. As a reminder, PAVmed remains Lucid's largest shareholder; its progress and upcoming major inflection points will benefit PAVmed. Just a couple of highlights from the call yesterday in addition to Medicare: it's clear that we're not remaining idle on the Lucid front. As we discussed, the VA's off-contract ordering following our securing the federal supply schedule and pricing has begun. First orders are being placed, that pipeline is being expanded and we move forward to driving volume and revenue along that segment. We also discussed our direct engagement with commercial payers: we have received positive coverage under one of the laboratory benefit managers and that will be publicly disclosed. And, of course, Lucid was also able to successfully raise additional capital that extended its runway well into 2027. So now let's move on to Veris. As we discussed in our last call, Veris is now well into the commercial phase of our strategic engagement with Ohio State University. That process is well underway. The clinical rollout has been focused on the three clinical departments that participated in the successful pilot study, and we're now on the cusp of adding additional departments according to our rollout schedule that OSU leadership developed in collaboration with us. As we noted last time, the EHR integration is now live and it's working well. Overall, the feedback both from the clinical and the administrative side from our partners at OSU remains excellent. We look forward to continuing to drive towards the targets that were established with them as part of our strategic partnership. A major focus right now is on the implantable physiologic monitor. That development is progressing toward planned submission by the end of this year. As we discussed last time, we have a new contract development and manufacturing partner firm; that partnership is going well. That's Velentium, and the design and development efforts leading to design freeze and the transition to final pre-submission development work and testing are going well. A lot of the recent efforts have been around the technical aspects of optimizing the battery life to get a full two years of battery life, and we've made excellent progress on that and look forward to continuing the work toward submission by the end of the year. We're also continuing to work on an expanded strategic vision for the company that we spent time discussing during our last call. That includes ultimately expanding our commercial leverage beyond our single strategic partner and a variety of initiatives that are focused on transforming our offerings beyond simple remote patient monitoring into additional strategic areas. We're looking to leverage our commercial success at OSU to support expansion into additional centers. Other aspects of the strategic transformation that we are working on, although within the limited confines of our capital resources today, include additional work on clinical support services and development efforts around AI-based projects beyond remote patient monitoring. With that, I'll hand the call over to Dennis for an update on the financials.

Dennis McGrath, Chief Financial Officer

Thanks, Lishan, and good morning, everyone. Our summary financial results for the first quarter were reported in our press release that was distributed. On the next three slides, I'll emphasize a few key highlights from the first quarter. But I encourage you to consider those remarks in the context of full disclosures covered in our quarterly report on Form 10-Q as filed with the SEC. With regard to the balance sheet, you'll recall from our last investor update that in February, we completed a $30 million Series D preferred stock offering. Concurrently, the company issued a $15 million senior secured note to an existing investor. The company used the proceeds from these financings, consisting of a $22.3 million cash payment and a $15 million senior secured note with a February 2029 maturity date, to redeem all of the outstanding shares of the Series C convertible preferred stock and fully retire its previously existing convertible debt. The $15 million replacement note nominally has a conversion price of $450 per share. It was done this way to protect the investors' tax status but in every substantive sense this is a long-term three-year note with interest-only quarterly payments and a balloon payment at maturity in February of 2029. Shareholders approved the conversion: just a couple of weeks back on March 27, the newly issued Series C preferred were mandatorily converted to PAVmed common stock. As a result, the Series D preferred stock has been eliminated. In connection with this financing, the company also issued warrants now convertible into common stock, which are callable by the company upon publication of a positive EsoGuard LCD. A couple of things to point out on the balance sheet: cash at March 31 is $6.5 million, which is not inclusive of the expected $30 million to be received upon the warrants being exercised post-LCD publication, nor does it reflect the $2.5 million from the Veris warrants issued last year that are callable upon the Veris implantable device being cleared by the FDA. The equity method investment balance of $36 million reflects 31.3 million Lucid shares mark-to-market, indicative of a $1.9 million increase in the quarter. At present, as Lishan indicated, PAVmed continues to be the single largest shareholder of Lucid Diagnostics with ownership of approximately 15% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, PAVmed together with its board and management still have significant influence over Lucid with approximately a 25% voting interest. Shares outstanding today, including unvested RSAs, are approximately 7.3 million shares. The GAAP quarter-ending outstanding shares of 6.3 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. You'll recall GAAP shares do not reflect unvested RSA amounts. Similar to past presentations, the P&L slide provides some GAAP and non-GAAP year-over-year quarterly comparisons. On a pro forma basis and purely for illustrative purposes on this slide only, the Veris revenue and the Lucid management fee income are combined, collectively more than $3 million per quarter. This is simply to visually align PAVmed's income sources versus operating expenses. For SEC reporting purposes, the MSA income is a below-the-line item. For the first quarter, you see on the slide a GAAP net loss of $1.1 million before noncontrolling interest and preferred dividends versus the prior year profit of $18.6 million. The driving force of this difference is the change in the fair value of the Lucid shares mark-to-market for each period. There are a few other income and expense noncash pluses and minuses that all relate to the accounting for the securities issued versus the securities redeemed that are largely non-cash items together with out-of-pocket financing costs related to the Series D issuance and the conversion to common shares. The GAAP net loss attributable to PAVmed as reflected in the 10-Q and also shown in the press release is $60,000 for the quarter, prior to the effect of the preferred dividends of approximately $6.9 million. The result after the preferred dividends is a GAAP loss per share of $4.42 per share. Without the preferred dividend, the pro forma GAAP net loss per share would have been $0.04 per share. 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 more detail in our press release. The first quarter non-GAAP OpEx of $5.9 million is above the average of the previous four quarters by about $1.1 million, which reflects about $300,000 in incremental R&D expenditures and the balance in G&A costs that were incurred in connection with the recapitalization financing and other professional fees. OpEx increases moving forward are likely to be tied mostly to the R&D efforts to get the Veris implantable device submitted and cleared by the FDA for which the 2025 Veris-related financings are supporting. With that, operator, let's open it up for questions.

Operator, Operator

Our first question is from Ed Woo from Ascendiant Capital.

Edward Woo, Analyst, Ascendiant Capital

Congratulations on all the progress. You guys are reviving possible new potential opportunities. Have you considered looking at opportunities outside of North America or outside of the U.S.?

Lishan Aklog, Chairman and Chief Executive Officer

We've always been open. We have historically gotten inquiries from, particularly in Europe, on occasion. I would say the majority of the technologies that are brought forth to us come from the U.S. Many of them come from academic medical centers. The founders of PAVmed and I have a strong history in academic medicine and have maintained those ties, so that's been a common source of inquiries. I'll remind people that the Lucid diagnostics opportunity came from a partnership with academic medicine and the Actaris technology that we're launching is in conjunction with Duke and investigators at UMMC. The ecosystem for physician-led innovation is particularly robust as well. So we're open to other sources, but the majority comes from within the U.S., including the ones that I had mentioned that we're actively pursuing. As I mentioned, we did a deep dive on one asset, which we passed on, and are in the process of doing another. And your last question: have we decided to focus either on devices, diagnostics, or therapeutics, or are we open to all three areas? It's a great question. I think it's a good opportunity to talk a little bit about the history of PAVmed and one of the things we're proud about, which is our willingness to be bold and explore new areas. PAVmed was launched initially exclusively to operate in the medical device space with initial assets focused on traditional medical devices. Because of the way things evolved, our mission was to be open to evaluating opportunities across the life sciences. A few years after PAVmed was founded, the technologies underlying Lucid were brought to us from relationships with an academic medical center. Even though this was in diagnostics, it had a cell collection device element, which is a medical device, but at heart Lucid is a diagnostics company, and we chose to make that leap, and we're obviously happy we did. Veris was brought to us as well; although Veris has an implantable medical device at its center, the foundation is digital health and software. Similarly, we expanded into digital health. Right now, digital health and diagnostics are very much on the table. We've also looked at therapeutics; one of our board members has deep experience on the therapeutic side. We've looked at numerous assets in the therapeutic space, we just haven't pulled the trigger yet. We expect to continue to evaluate therapeutics. The opportunity there is we have the infrastructure for clinical research and the ability to run trials necessary to create value, but the challenge previously was availability of capital needed to enter into license fees or acquire assets. Our prior capital structure constrained us. Now that we've completed the restructuring and recapitalization, we're in a better position and expect to have an opportunity to look at therapeutic assets as well.

Operator, Operator

Your next question is from Jeremy Pearlman from Maxim Group.

Jeremy Pearlman, Analyst, Maxim Group

While we're talking about the relaunched device portfolio, how does that differ from the incubator setup? Is that the same thing just rebranded, or is there a difference?

Lishan Aklog, Chairman and Chief Executive Officer

That's a fair question. The slight difference is as follows: when we were going through the two-year restructuring and recapitalization, we were motivated to start taking product lines and IP that we had put on the shelf and advance them. Initially, we put those assets into an incubator, starting with PortIO, and that gave us the opportunity to try to raise capital for each asset out of the incubator. It was tough to do that. We went through multiple angel processes and the structure didn't yield the results we were hoping for. Also, we were not well positioned because we hadn't completed the restructuring. Now that the recapitalization is completed, we decided to tweak the relaunch of the medical device portfolio, learning the lessons from the incubator approach, and we recognized the importance of having an experienced, highly skilled person at the helm for the entire portfolio. That's why we brought someone with prior CEO experience and deep experience in the medical device industry to manage the relaunch. He is working on PortIO and other technologies; in the interim, we've licensed new imaging technology for dysplastic esophagus and other opportunities in medical devices, all integrated within the PAVmed infrastructure. Our manager has access to the full shared services model, but we now have a dedicated person working on those technologies every day. We expect that will facilitate our ability to raise capital into subsidiaries that are advancing those individual medical devices. On criteria for potential technologies, we've been consistent from the inception of the company: technologies addressing a meaningful unmet clinical need; substantial market opportunities; and a bias toward high-margin, less commoditized products because our infrastructure is better suited to those. We're open and flexible, which is one of our strengths. Additionally, there are synergies with Lucid on the diagnostics side; many of the assets we've looked at recently have fascinating opportunities in molecular diagnostics. Finally, our experience with Actaris and the evolution with Lucid and Veris highlights our interest in gastroenterology and oncology intersections. Technologies that intersect those spaces are of particular interest, as exemplified by Actaris, which enhances diagnosis of Barrett's esophagus, a pre-cancer condition.

Jeremy Pearlman, Analyst, Maxim Group

Moving to the Veris platform: how many patients have you signed up? I think in the past you mentioned a target enrollment by the end of this year of 1,000 patients. How is the ramp trending? Any headwinds or is everything smooth?

Lishan Aklog, Chairman and Chief Executive Officer

We're not going to put exact numbers publicly, but yes, it's trending and on target. When we launched the commercial phase of our strategic engagement with OSU after the pilot, they put forth a very detailed rollout plan to reach the target of 1,000 patients within the first year of the registry. The trajectory is not linear; there were delays initially, particularly with EHR integration, which took more time than we had hoped for. Overall, we're on target to hit those goals. Very soon we will expand to the next phase of departments within the cancer center. The first three departments launched were the same ones that participated in the successful pilot; the next phase includes departments that did not participate in the pilot, all consistent with the well-laid-out rollout plan. As for feedback, it's a continuous learning process. We're focusing our development capital on the implantable device because the value proposition is rooted in both the software platform and the implantable. That said, engaging with a single large cancer center allows us to show value, generate enthusiasm locally, ramp meaningful numbers, and get the kinks out with regard to EHR integration and process issues. This is not trivial: patients have newly diagnosed cancer and complex therapies and clinical events that must be communicated to the care team. One example with OSU: they have a dedicated call center, so all alerts go through that call center. We are learning how to manage that, how to staff it, and how to optimize the flow of information in a way that optimizes care. We are focusing lessons at one center so that when we are in a position—both from a development and capital point of view—to expand commercially, subsequent centers will benefit from what we've learned here. On commercialization timing and expansion: we have had conversations with other academic medical centers and practice networks and other entities engaged in the care of cancer patients. We're unlikely to pull the trigger on another major engagement until we're in a position to raise additional capital so we can do it right. The next phase of commercialization will be aligned with our ability to raise additional capital to support an expanded commercial footprint. That could happen prior to the submission and clearance of the implantable device; it really just depends on how well we're positioned to fund commercial expansion.

Operator, Operator

There are no further questions at this time. I will now hand the call back to Dr. Lishan Aklog for the closing remarks.

Lishan Aklog, Chairman and Chief Executive Officer

Great. Thanks, operator, and thanks all of you for taking the time and for your attention this morning. I really appreciate the questions and enjoy the opportunity to have substantive discussions with our covering analysts; I hope you all found that enlightening as well. Just to summarize: as we discussed, we believe we're now in a strong position to advance PAVmed's strategic plan and original mission. Our two independently financed commercial subsidiaries, Lucid and Veris, are progressing well and are both approaching key milestones. As importantly, the completion of our restructuring and recapitalization process has allowed us to begin expanding our horizons consistent with PAVmed's original mission. This includes relaunching our medical device portfolio under Virgilio and aggressively evaluating and pursuing additional assets and opportunities that align with our model and growth strategy. As always, we encourage you to continue to keep abreast of our progress through our news releases, these update calls and on our website and social media. Feel free to reach out with any specific questions. I hope everybody has a great day, and thanks for your participation.

Operator, Operator

Thank you, ladies and gentlemen. The conference has now ended. Thank you all for joining. You may now disconnect your lines.