PAVmed Inc. Q2 FY2023 Earnings Call

Thank you, Rocco. Good morning, everyone, and thank you for participating in today's second quarter 2023 business update call. The press release announcing our business update for the company and financial results for the three and six months ended June 30, 2023 is available on the PAVmed website. Please take a moment to read the disclaimer about forward-looking statements. The business update press release and this conference call include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the U.S. Securities and Exchange Commission. For a list and description of these and other important risk factors or risks and uncertainties that may affect future operations, see Part I Item 1A entitled Risk Factors and PAVmed's most recent annual report on Form 10-Q filed with the SEC and subsequent updates filed in quarterly reports on Form 10-Q and any subsequent Form 8-K filings. 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, PAVmed Chairman and CEO. Dr. Aklog?

Thank you, Mike, and good morning, everyone. It's great to have you here, and I appreciate you joining us. We spent some time discussing the business aspects of Veris and Lucid. As you may know, we held a Lucid call yesterday, which is available on our website. Therefore, I will focus primarily on Veris and share some recent highlights. The Veris Cancer Care platform is making a difference at early adopter practices. For example, we are developing a next-generation version of the platform, set to launch in early the fourth quarter. We are also restructuring and expanding our commercial team under Gary Manning's leadership, aiming to accelerate patient enrollment and subscription revenue in the latter half of the year. We've introduced two new strategic initiatives since his arrival. One involves creating a module for the platform focused on biopharma, which will act as a companion digital platform to novel cancer therapies. Additionally, we are upgrading the platform to function as software as a medical device, with plans for FDA submission in 2024. This will enhance its functionality for clinical decision support. The implantable monitor aspect of our project is progressing well, with a goal for FDA submission and commercial launch in 2024. Regarding Lucid, our quarterly test volume grew 20% quarter-on-quarter. We've upgraded our revenue cycle management infrastructure, which has already positively impacted claims, payments, and revenue within the first six weeks of the transition. We are at an inflection point in converting test volume growth into revenue. We have reached the first enrollment milestone for two prospective clinical utility studies, which will soon be submitted for publication. We've also noted unprecedented results from the NCI-funded EsoGuard study and secured our first direct employer contract offering EsoGuard as an employee benefit. For those of you unfamiliar with the PAVmed story, we are a diversified commercial-stage medical technology company operating across devices, diagnostics, and digital health. Our structure includes two majority-owned subsidiaries: Veris Health, a private digital health company focused on cancer care, and Lucid Diagnostics, a public Nasdaq company concentrating on early detection of esophageal pre-cancer. Veris is committed to enhancing personalized cancer care and has two components: one currently commercialized and the other expected to launch next year. The Cancer Care platform consists of a patient smartphone module and a clinician portal connected to a VerisBox of devices that transmit physiological data from patients to their healthcare providers. Our mission is to utilize modern remote patient monitoring tools to improve care through early detection of complications and risk management. The business model is based on software-as-a-service and we have established RPM coding, ensuring reimbursement is not a significant hurdle. We also aim to leverage value-based models focused on oncology, such as the Enhancing Oncology Model. We have several early adopters, primarily small to medium practices, actively using the platform and integrating it into their operations. In the last quarter, we prioritized customer integration support to streamline the process. The feedback has been positive and has informed features for our next-generation platform, which is actively in development and scheduled for launch in early the fourth quarter. Under Gary Manning's leadership, we are also restructuring and expanding our commercial team to drive growth in subscription revenue. Let me highlight a specific example of how remote patient monitoring can prevent adverse outcomes and save lives. A 71-year-old patient named Dave was diagnosed with bile duct cancer and was undergoing treatment at a Veris client in Southeast Pennsylvania. Given his high risk of complications, he was enrolled on the Veris platform. He received the VerisBox with Bluetooth-connected monitoring devices and the platform loaded on his smartphone. The platform serves as a monitoring system, allowing the patient to report symptoms and physiological changes. When Dave reported abdominal pain, the nursing staff took note of his symptoms and concerning changes in his heart rate and oxygen saturation. The nurse contacted him via the telemedicine portal, provided guidance on the situation, and educated him on when to seek emergency care. Consequently, when his symptoms worsened, he was admitted to the hospital and diagnosed with an acute bowel obstruction. Fortunately, it was treatable without surgery, allowing him to avoid a lengthy hospital stay and continue with his cancer treatment. This case illustrates how our platform enhances care by enabling early intervention in high-risk patients, potentially averting serious complications or surgical emergencies. Our documentation shows significant cost savings for hospitals by preventing complications, which also helps ensure practices maintain their revenue from infusion therapy. We have introduced two new strategic initiatives concurrently with Gary Manning's appointment. The first is a companion digital platform focused on biopharma therapeutics, which will provide long-term patient monitoring solutions linked to new cancer therapies. This will begin during clinical trials and continue through to regulatory approval and commercialization. The analogy here is with companion diagnostics commonly used in the past fifteen years, where a drug is coupled with a diagnostic test throughout development to ensure safe use and efficacy. The second initiative is transitioning the Veris platform to a software-as-a-medical device. Currently, the Veris platform is classified as a medical device data system, with limited functionalities. We plan to upgrade it so that it will actively assist in diagnosing and treating patients, which will open up opportunities for advanced clinical decision support and allow us to deploy more sophisticated algorithms for risk profiling and alerts. In conclusion, we look forward to submitting our next-generation platform for FDA validation next year. Additionally, the implantable monitor will ensure compliance with remote patient monitoring requirements, providing continuous monitoring without depending on patient compliance. In summary, we are observing substantial growth in EsoGuard testing volume and made significant academic advancements with the recent BETRNet study, showing exceptional performance in cancer detection compared to existing tests. As we move forward, we aim to capitalize on our strengths and continue making strides in cancer detection and patient care. I'll now hand the call over to Dennis.

Thank you, Lishan. Our summary financial results for the second quarter and the first half of the year were published in our press release last night. In the next three slides, I will highlight a few key points from the quarter, but I encourage you to consider these remarks alongside the full disclosures in our quarterly report on Form 10-Q, which was filed with the SEC on Monday afternoon and is available on the PAVmed website. Slide 17 shows our balance sheet comparison, indicating cash of $37.2 million, reflecting a sequential burn rate of $12.1 million. This is a $2 million improvement over the first quarter and a $5 million improvement compared to the fourth quarter of last year, linked to our cost control initiatives implemented at the start of the year. It’s important to note that this cash balance does not account for the remaining $10 million draw available under the securities purchase agreement from March 2022 or other resources available to both PAVmed and Lucid. On a pro forma basis, taking into account the remaining securities purchase agreement and assuming the net burn rate remains steady, our runway is about a year. Additionally, as our cash collections keep increasing, as I will explain shortly, this could further reduce the burn rate in the upcoming quarters. Vendor payables remain flat sequentially, while other current liabilities increased by $1.6 million, primarily due to annual insurance renewals which will be paid over the next year. The convertible note decreased sequentially by approximately $1.3 million, mainly due to debt repayments via conversions to common stock during the quarter. Other long-term liabilities pertain to capitalized leases for our lab and office spaces. As of today, there are 111.4 million shares outstanding, which includes unvested restricted stock awards. The GAAP outstanding shares of 108.5 million are also included in the slide and on the face of the balance sheet in the 10-Q. On the next slide, Slide 18, we compare this year’s second quarter to last year’s second quarter, along with the six-month totals for key items. I trust you will review my comments in light of the cautionary disclosure at the bottom of the slide regarding supplemental information, especially non-GAAP information. Revenue for the second quarter reflects actual cash collections from Lucid for insurance reimbursable claims, invoiced EsoGuard tests from the Veterans Administration, and initial billings from the adverse Cancer Care platform. As mentioned in our Lucid quarterly call yesterday, we highlighted the major change and upgrade to Lucid's revenue cycle management. We decided to stop submitting claims for reimbursement at the beginning of May to facilitate the onboarding of Quadax, our revenue cycle management partner, which began in mid-June. This change improved the processing and reporting of claims we had in hand. Since the start of the third quarter, from July 1 to now, collections from third-party reimbursement claims have tripled compared to the entire previous quarter. The Veris revenue for the second quarter reflects initial payments from approximately 90 patient months from the first two onboarded cancer care centers during their acceptance processes, which included validation, customization, integration with EHR systems, and rigorous pressure testing of the platform. The platform is functioning as expected, generating patient case reports that highlight life-saving capabilities through remote monitoring, as Lishan noted in his remarks. Regarding last year’s revenue, you might recall there was a fixed monthly fee from a third-party lab used before we established our own lab, which ended in February 2022. Lucid's revenue recognition will depend on the probability of collection, meaning that revenue is recognized only when a claim is collected rather than when the patient report is invoiced. You will see in our 10-Q this is described as variable consideration in line with GAAP ASC 606 revenue recognition guidelines. We expect to continue to recognize Veris revenue based on incurred and invoiced basis per standard GAAP rules. A few comments on GAAP and non-GAAP operating expenses and net loss are worth noting. The presentation shows year-over-year comparisons, but I'll focus on sequential changes indicative of our trajectory for the rest of the year. Our second quarter GAAP operating expenses and GAAP losses decreased sequentially by over $4 million each, reflecting a 20% decrease for both measures. Our second quarter non-GAAP operating expenses fell sequentially by $2.3 million and by $4.8 million from the fourth quarter, equating to reductions of 15% and 27% sequentially, a result of the cost controls initiated at the beginning of the year. Our second quarter non-GAAP loss per share is $0.09, down around $0.01 from the first quarter and an improvement from a loss of approximately $0.15 in the fourth quarter. Slide 19 graphically depicts our operating expenses detailed in our press release. The second quarter's sequential decrease was primarily driven by a $1.5 million reduction in general and administrative expenses and a $1 million decrease in research and development. Sales and marketing expenses remained relatively stable, while the small increase in the cost of revenue is largely due to greater test volumes for the quarter. The cost of revenue mostly consists of Lucid lab supplies and fixed lab costs, with a minor portion attributed to delivery costs for the Veris Health Cancer Care platform. I will share additional statistics discussed in our call yesterday concerning the revenue cycle management improvements. Since Quadax took over on May 1 and began onboarding claims in mid-June, they have submitted over 2,100 claims, including all backlogged claims existing at that time. Almost half, or 943 claims, have already been adjudicated by insurance companies, resulting in an allowed amount affirming the payment obligation for 349 claims, or 37%. Notably, the allowed amount aligns at $1,890, validating our payment rate established by Medicare. We are witnessing faster claims submission, adjudication, and allowable claims at a significantly higher rate than previously reported. Whether the 37% success rate will persist or further improve remains to be seen, but Quadax is demonstrating notable effectiveness along with actionable data reporting. This includes addressing initially denied claims through their appeals process, which they are now ramping up. There are around 200 appeals in process, primarily due to the number one reason for denial being medically unnecessary. We are aware that guidelines from two medical societies establish the criteria for these tests, which patients only undergo if they meet established risk factors. Thus, we believe the appeals process will be beneficial in two ways: enhancing revenue collection and drawing significant attention from the Chief Medical Officer, helping facilitate movement towards in-network participation as we leverage our two-fold clinical utility data along with claims history to improve the reimbursement process.

Thank you. Today's first question comes from Frank Takkinen with Lake Street Capital Markets. Please go ahead.

Lishan, Dennis, thanks for taking the questions. Congrats on progress. I'll start with one on the biopharma cancer care platform given that you spent a fair amount of time talking about today. I don't think I heard you guys talk about a timeline on that, but maybe walk through when we could see that develop? When we could see what needs to occur from a regulatory process, if anything at all? And when we could see that maybe launch live?

Thank you for the opportunity to discuss this. As you may remember, we had identified this as a strategic goal for the future. With Gary joining us, we can conduct a more thorough exploration and have realized we can achieve two key things that are different from our initial plans. First, we can accelerate the timeline significantly. Second, we can enhance the value proposition not only for clinical trial support but also as a comprehensive companion technology for diagnostics. Currently, we are in the process of defining the project scope. The reason for the much shorter timelines compared to our original expectations is that we can integrate it as a module on our existing platform, which means we don't need to build an entirely new structure from the ground up. After confirming this with our excellent software development partner, Loka, we have started the project scope. We are figuring out the design structure, but since it will be a module within our platform, we anticipate the timeline will not be lengthy. While we aren't providing specific guidance on timelines yet and lack complete visibility, we believe it will be a matter of months or quarters rather than years.

Perfect. That's helpful. And then maybe just to stay on that topic, could you talk about what a business model could look like there once you start to sign partnerships with biopharma companies?

Yes, this is a completely different scenario. The value for the pharmaceutical company is quite substantial. For instance, CAR-T therapy, which is one of the more costly immunotherapies, can cost $1 million per patient and comes with significant complications like cytokine storms. Therefore, having a platform that can monitor patients during clinical trials and enhance the safety profile of such drugs, as well as continue monitoring post-market approval, is crucial. We foresee the business model involving a service arrangement with the pharmaceutical company for the services rendered throughout the clinical trial and research phase. Additionally, there will be a framework for utilizing the platform in conjunction with the drug on a subscription basis. This relationship will be closely intertwined with the partner pharmaceutical company, ensuring that our platform and the drug remain closely connected in the foreseeable future.

Frank, an eye opening on this topic is if you have a $1 billion a year drug, every month that you allow them to get into the market, that opportunity cost that they lose is about $80 million a month. So, if we can save them a month or three, it is a significant opportunity for them to couple this as a companion to get that on the market sooner to be able to monitor safety of its performance.

I understand. That's useful. For my final question, I want to focus on the Lucid business. With the clinical utility studies expected to be submitted for peer review by the end of the month, it seems that meets the final key requirement that CMS outlined regarding guidelines, utility, and validity. Given this, I assume you can quickly advance the finalization of that establishment with CMS, and can you also share your thoughts on private payers and when we might see their responses based on the futility data?

Yes, I'm going to turn your question around a bit. On the private side, things are quite straightforward because we deal with individual payers and can have more open discussions regarding efficiency, data, and any additional information they might require. This can begin as soon as the data is posted on the preprint server, even before peer review. Since over 80% of our patients are commercially insured, we see immediate opportunities to influence coverage based on the results from those 500 patients. The situation is more rigid with CMS, where we would likely take that data and engage with them to see if it meets the thresholds outlined in the local coverage determination. We are confident that it will meet those thresholds, as our previous meeting before the draft LCD was specifically focused on clinical utility, and our plans aligned with their expectations. Therefore, I don't anticipate that once published, we'll simply submit the technical assessment and just wait. Instead, I believe we'll have some discussions with them to ensure we have their confidence before proceeding.

And our next question today comes from Ed Woo with Ascendiant Capital. Please go ahead.

Yes. Congratulations on the progress. My question is on the Veris sales force. You said you guys are restructuring and expanding it. Is there a target size for the sales force? And in terms of geography, are you guys having a nationwide reach or is there a focus on a certain region of the country?

Yes, those are great questions. We are not concentrating on specific regions at this time. Our initial focus has been on smaller practices where the challenges related to IT infrastructure integration are less significant, although we are in active discussions with several large academic cancer medical centers. We plan to start small and expand as we progress. Currently, the plan is to hire two salespeople, and we are in the process of interviewing candidates for the second half of this year. We will increase the team as we gain traction. So, for this quarter, there will be two salespeople plus Gary, and we will consider further expansion next year.

Great. And then as you guys start to focus on this biopharma program, will it require a different type of sales force? Or can you use your existing salespeople to try to go into that market?

Yes, I believe it will be somewhat different but also quite similar to what we're seeing on the Lucid side. There’s a distinction between the salespeople who engage with primary care practices and specialists and those who focus on strategic accounts. This would align more with that latter approach. Initially, much of the engagement will be led at the highest level, with Gary primarily interfacing with biopharma companies regarding this opportunity.

And our next question today comes from Ross Osborn at Cantor Fitzgerald. Please go ahead.

So regarding commercialization of Veris, has New Jersey Cancer Care expanded the use outside of the initial group of patients? And as a follow-up, given this was launched in February, can you provide an average use time per month in order for us to better understand the revenue potential?

Okay. Let's break that down. They are adding patients to their platform, as they hinted in the patient example, even though that wasn't from their group. The general approach has been to identify a cohort of the highest risk patients to bring on the system first. We've been focusing over the last couple of quarters on ensuring that all the technical aspects are in place so that when patients receive their device, they can transmit data correctly and maintain high compliance levels. This allows physicians to track their time on the system for proper billing under various codes. It's crucial that all of this is functioning smoothly, and we have been dedicating our resources to the current sites, which is working well. There has been some feedback that we are incorporating into the next-generation device, but overall that is progressing well. Regarding compliance, even though we indicated that the implantable platform would enhance compliance, we are achieving nearly 100% compliance with patients reporting at least 16 days a month of parameters for the practice to drill. The challenges with practice billing were more about documentation and ensuring we have a streamlined way for them to log their time, and that is being effectively developed. I think that covers the various components of your question. If I missed anything, please let me know.

No, that's perfect. Thank you. And then just a quick second question. Ahead of the next-generation launch, can you talk about how you're marketing that offering maybe to larger practices or institutions?

How we're marketing the implantable device? Or the Gen 2 version of the software platform? I just want to make sure I'm talking about the right product.

Well, both would be great, if you can.

The next-generation software platform consists of incremental advancements based on the feedback we've received from practices. It will essentially be a smooth upgrade of a new generation device. We won't be marketing it any differently. The implantable device will not be available next year, and we don't have a specific date yet. We are still in discussions with the FDA and are working on related timing issues with our contract manufacturing partners. When we do launch it, we haven't fully articulated our marketing plan externally. There are several factors still to determine, including whether we will charge for the device, how much we will charge, or if we will set a premium price compared to existing products. This will depend heavily on the valuable real-world information we gather from the software platform, particularly regarding how effectively we capture revenue opportunities from remote patient monitoring. That data will be crucial in helping us position the implantable device to enhance the commercialization of the software platform and ensure they work in synergy. Therefore, we are delaying final decisions on this until we gain more commercial experience from the platform and understand the timing better.

And our next question comes from Anthony Vendetti with Maxim Group. Please go ahead.

I just want to follow up. We've discussed the biopharma opportunity, and it certainly seems promising. Regarding the 510(k), if development takes a few months or quarters and wraps up by the end of this year or the beginning of next year, would this be a new 510(k)? Presumably, the predicate device would be your device with the Software-as-a-Service added on, or would it simply be an amendment to include Software-as-a-Service?

Yes, let’s clarify that we are discussing the equity. The biopharma platform does not require us to shift to a software-as-a-medical device. Instead, it will extend the current MDDS functionality, merely focusing on data reporting organized for clinical trials. This software development is set to begin, although we do not have a completion timeline yet. Importantly, there are no additional regulatory hurdles, and we believe we can efficiently produce at least a first-generation product for pharmaceutical companies in the near future. This differs from our second strategic initiative, which involves upgrading the existing MDDS version to officially qualify as a software-as-a-medical device. The predicate for this is not our current system since it is not a 510(k) system; it operates under MDDS. However, we have identified several other predicates that will be suitable, and this will lead to a new 510(k) for the software-as-a-medical device. The required steps involve the usual validation processes for software as a medical device. Does that make sense?

Yes, sure. No, that makes sense. And do you think, based on the comments, did you say you would probably be looking to submit that in the beginning of '24?

Yes. I think sometime by the mid-portion of '24. We don't have full visibility yet. We don't have the scope yet of the validation testing. So this is a new initiative. We'll need to have some pre-subs with FDA to make sure that we have the validation plan and the predicates and so forth, well in line. So, I would just maybe pencil it in for next year as a target, that's subject to our interactions with FDA.

Okay. You mentioned examples like CAR-T, but what are the potential uses for monitoring patients and integrating with other therapies, whether they are existing or in development? Considering all these factors, have you estimated a total addressable market? What do you think it could be?

Yes. Let me add to the qualitative question first. There should be no limitation on the range of cancer therapeutics applicable here because every therapy offered, whether immunotherapy, chemotherapy, or oral IV infusions, is associated with significant complication rates that could theoretically be reduced with more intensive monitoring. We don't see limitations in that regard. Regarding the distinction between new and existing drugs, our initial focus will be on new drugs because their connection to the software platform will be much stronger if established during the development and clinical phases of clearance. They essentially become inseparable. There is also an opportunity to take existing drugs and potentially combine them, as seen in diagnostics where generic drugs are paired with companion diagnostics, suddenly creating proprietary drugs that can demand a premium. We haven't explored this in detail, but it is part of the opportunity. As for the total addressable market, it is very large because even a small single-digit percentage of the cost or price of a drug attributed to the added value of linking it with a digital health platform for improved safety results in a significant number. I'll leave it at that. Yes, there are companies working on generic remote patient monitoring, and there aren’t significant barriers to entry in that space. Some are digital platforms focused on cancer, and a few combine both approaches, but none are as closely tied to fashion as we are. Once we launch our implantable device, which has associated intellectual property, that will create a significant barrier to entry. Most offerings we observe are somewhat generic and centered around patient engagement rather than providing a highly efficient clinician platform integrated with clinical practice. Our platform is designed by radiation oncologists, and we've received very positive feedback from practices regarding its integration into oncologist workflows. The introduction of the implantable device will represent a substantial advantage for us, and its added value will be significant.

Thank you. And ladies and gentlemen, this concludes our question-and-answer session. I'd like to turn the conference back over to management for any closing remarks.

Great. So I'd like to thank all of you for your attention and for spending the time with us this morning and for all the excellent questions and discussion. I'd encourage you to keep in touch with us like contacting Michael Parks at mep@pavmed.com with any questions or comments and following us on social media and our website on the way. So, thank you very much, and look forward to a good day. Bye.

Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.