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PAVmed Inc. (NASDAQ:PAVM) Q3 2023 Earnings Call Transcript

PAVmed Inc. (NASDAQ:PAVM) Q3 2023 Earnings Call Transcript November 15, 2023

Operator: Good day, and welcome to the PAVmed Third Quarter 2023 Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's remarks, there will be an opportunity to ask questions. [Operator Instructions] Please also note that today's event is being recorded. I would now like to turn the conference over to Michael Parks, Vice President of Investor Relations. Please go ahead, Michael.

Michael Parks: Thank you, Operator. Good morning, everyone, and thank you for participating in today's third quarter 2023 business update call. The press release announcing our business update for the company and financial results for the three and nine months ended September 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 both 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.

A close-up of a high-tech medical device, representing the company's cutting-edge products.

For a list and description of these and other important risk factors or risk factors and uncertainties that may affect future operations, see Part 1, 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. 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, PAVmed Chairman and CEO.

Dr. Aklog?

Lishan Aklog: Thanks, Mike, and thanks everyone for joining us this morning. We look forward to providing you with this update on PAVmed's business and finances. First, a quick reminder that we held a separate business update call for PAVmed subsidiary Lucid Diagnostics yesterday. Today I will limit my comments on Lucid's business to key highlights. I would encourage you to view the recording of yesterday's call, which is available on the Lucid website, for further details from Lucid's business update. First some quick background. PAVmed is a commercial-stage medical technology company with two subsidiaries, which are marketing commercial products, privately held Veris Health and NASDAQ-listed Lucid Diagnostics. As the parent company, PAVmed provides a shared services infrastructure, including management services to each subsidiary.

The model drives substantial economies of scale and an infrastructure which facilitates licensing or acquisition of high-value assets, such as Lucid and Veris. We implemented a strategic restructuring in early 2023 to focus substantially all of our resources and efforts on our two commercial enterprises, Lucid and Veris. And this update will reflect that strategy. That said, I'll briefly note that we have one active internal R&D project in partnership with Novosound to develop a next-generation intravascular ultrasound device. That progress is progressing very well, having completed two or three milestones. I will also note, as I have in recent calls, we remain very active on the business development side since current market conditions offer a plethora of high-value assets which may provide real opportunities to enhance PAVmed shareholder values.

Let me start with some highlights for Veris and Lucid before proceeding to a deeper dive on Veris update. Veris Health is undergoing a commercial restructuring and expansion that is currently underway under the leadership of our President, Gary Manning, who started several months ago. We have active strategic discussions with large academic medical centers and feel there's great promise there. Our next generation of Veris Cancer Care Platform is scheduled to launch this quarter. And we have active discussions with large biopharma companies on the Cancer Care Platform's biopharma module to serve as a digital companion for novel cancer therapeutics. Finally, the implantable model -- monitor, excuse me, is progressing towards FDA submission and commercial launch in 2024.

As I mentioned yesterday, Q3 has been the most important quarter in Lucid's history as we've crossed several critical milestones in translating study test volume growth into revenue and revenue growth. Briefly, quarterly EsoGuard test volume grew 17% and quarterly revenue growth increased 376%. Our revenue cycle management upgrades has demonstrated solid progress in the first full quarter reporting. Clinical utility studies with near perfect results have had their results released and two of them have been accepted for peer review publication, one is pending. Our direct contracting initiative has netted its first employer contract and our new VP of employer markets is pursuing -- offering EsoGuard as a benefit to employers. And finally, as we announced this week, EsoGuard 2.0 is launched with potential -- with clear benefits in performance as well as in the per sample assay costs.

Let's now proceed to a deeper update on Veris. Next slide. Veris Health is a commercial-stage digital health company that seeks to enhance personalized cancer care. We have two features. One is the Veris Cancer Care Platform, which has a patient module that operates from a smartphone and is able to transmit physiologic parameters from connected devices as part of our Veris box. It also includes a clinician portal where that data is presented to clinicians and provides a variety of opportunities for the cancer care team to interface with the patient and enhance their care. We also have an implantable monitor that's in the works, that is designed to be implanted at the same time as a chemotherapy or immunotherapy port. Veris's mission is to utilize modern remote patient monitoring tools to improve care through early detection of complications, longitudinal trends, and risk management.

Next slide. The opportunity to improve patient outcomes, increase workflow efficiency, and lower costs results in a substantial market opportunity. There are millions of hospitalizations for cancer per year, and about two-thirds of them are unplanned admissions with substantial cost to the hospital. And 20% of these unplanned admissions are likely preventable. This results in a total addressable market opportunity of approximately $2 billion. The business model is very attractive. It's a software as a service recurring revenue model that leverages established remote patient monitoring codes. It also provides Veris with additional revenue opportunities through enhanced technical support and charging for clinical integration, clinical support such as our in coverage, as well as revenue opportunities directly derived from the implantable device.

It allows the clinical cancer care practice to leverage value-based models, such as the EOM or Enhancing Oncology Model that CMS provides. Next slide. A few updates on our commercial execution. We remain focused on several early adopters, which are small to medium oncology practice, and we spent the last several months focused on really ironing out the custom integration and customer support, engaging with patients, making sure that patients are able to report their data to streamline, to make that process as streamlined and efficient as possible for the practice operations and billing. Many of the -- much of the feedback that we've received from these early adopters and early engagements have been incorporated into our next generation 2.0 version of the Veris Cancer Care platform, which is completing its development and is expected to launch this quarter.

As I mentioned earlier, we've undergone a significant restructuring and expansion of our commercial team under Gary Manning's leadership since he took over several months ago. We recently hired two new market development managers with experience in this area that are now started and are actively calling on cancer care practices across the country to expand the number of accounts that we have under our belt, now that we have the next generation product that incorporates the feedback from our early adopters. We are, as I mentioned, in active strategic discussions with large academic cancer centers. The pathway for engaging with them is rather different and as always the case has longer lead times. And we're very excited about a couple of leads here which we hope to consummate into active accounts in the near term.

Next slide. As we introduced in our last call, there's a separate opportunity, the Bio Pharma opportunity that we're very excited about and we are aggressively pursuing. The goal here is for the Veris platform to act as a companion solution for post-market surveillance of novel oncology drugs. The numbers are quite impressive. It costs about $40 million per study to execute a Phase 4 post-marketing surveillance study for -- clinical study for oncology therapeutics and essentially all clear drugs are required to undergo that. And every day on the market costs about $2.7 million for $1 billion blockbuster drug. The goal here is to use the platform to create value for both the biopharma companies and the oncology practice through certified clinics to administer new therapies.

It allows drugs to move up the chain of therapy. So for example, if it's initially cleared as a third or fourth line drug to move as a second and first line drug with dramatic economic impact to the company and to increase patient adherence to care pathways that are very well defined during the post-market surveillance period. So we have active discussions with several large pharma companies to see if we can engage them to have the Veris Health platform and the bio-pharma module serve in this role. So we previously have talked about the full spectrum of opportunities, both in the drug development phase, around the time of FDA submission. But our initial focus right now, where we believe the greatest opportunity for near-term commercial impact is in the post-FDA approval phase, where during this market surveillance.

And that can include existing drugs that are working their way up the chain of therapy, as I previously explained. Next slide. As we have previously announced, we are also transitioning the Veris platforms from its current status within the regulatory framework as an NDDS or medical device data system, which is only displaying medical data for clinicians without modification into an SAMD, which is a software as a medical device, which under FDA regulations is intended for use in diagnosing or treating patients. The upgrades of this platform to an FDA cleared SAMD will provide us with really unlimited potential to grow into a full-fledged clinical decision support tool. So beyond just simply being a remote patient monitoring tool that transmits information, we'll be able to provide patient threshold alarms, alerts, notifications, triage, and even something called digital biomarkers that are based on AI and machine learning models for patient risk profiling.

So that process is progressing for an FDA 510K submission as a software as a medical device in 2024. Next slide. And finally, as I mentioned, we're very excited to be making solid progress on the Veris implantable monitor. This monitor, as you can see on the right there, is designed to have physiologic monitor, that's the silver structure there, that is implanted, which can be implanted in conjunction with an implantable vascular access port, which approximately 50% of cancer patients receive to have their chemotherapy or immunotherapy delivered. The key features will be continuous cardiac monitoring activity. It will have a patient-triggered event monitor, temperature, respiratory rate, and bluetooth connectivity that will supplement the existing external connected devices.

We have had multiple successful FDA pre-submission meetings, seeking feedback on all these various design features, and those have all gone extremely well, and we're progressing towards FDA submission and commercial launch next year. Once we have this in place, it will really be a game changer for the platform as it assures 100% patient compliance with the remote patient monitoring billing requirements and really provides a substantial added value both on the clinical care side as well as the economics for the medical -- for the practice and the institution. Next slide. So as I stated, I'll keep the overview of Lucid's business to some highlights from the third quarter. These were again covered in substantially greater detail on yesterday's Lucid call.

On the commercial execution side, we performed 2,575 tests – EsoGuard tests, which is a 17% quarter-on-quarter growth and 137% annual growth. Revenue of $784,000, which is nearly 400% quarterly growth and nearly double on an annual basis. We have strong contributions from our satellite Lucid test centers and our high volume check your food tube testing events, and we're gaining traction with several important strategic accounts. Other strategic accomplishments are that we recently upgraded our revenue cycle management infrastructure and processes as we announced in the last quarter, and the early results of that have continued and are delivering really solid results with EsoGuard claims processing and payments. We've had a very substantial boost to our clinical utility data to support in-network payer coverage engagement.

We have over 1,500 patients across three studies that have been released, the CLU study, Prevent Registries, and San Antonio Firefighter Department study. Two of these have been accepted for peer review publication and one is pending. We're accelerating activity and direct contracting with employers to offer the EsoGuard as a benefit. Our first contract is signed. Testing has begun and our new VP of Employment Markets is hired and will be starting this week. As we announced this week, our EsoGuard 2.0 assay has been launched in our laboratory in Orange County, California, with improved performance and lower costs. Next slide. I'll just point out the steady test volume growth, which represents eight consecutive quarters or two full years of quarter-on-quarter growth to [2575] (ph) and represents – and indicate, as shown here, that we still have substantial laboratory manufacturing capacity, which is currently over 10,000 tests per quarter.

Next slide. With that, I'll hand things over to Dennis who will proceed with our financial update.

Dennis McGrath: Thank you, Lishan. Good morning, everyone. Our summary financial results for the third quarter were reported in our press release that was published last night. On the next three slides, I'll emphasize a few key highlights from the quarter. I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q that was filed with the SEC -- previously filed with the SEC and is available on our PAVmed website. Slide 16. Our balance sheet demonstrates cash of $26.4 million, and it reflects a sequential burn rate of $10.7 million. We have successfully cut our burn rate in each of the first three quarters of this year, reflecting quarterly burn rate reduction of more than $6 million since the fourth quarter of last year for an average reduction of $2 million in each successive quarter.

These improvements are related to the cost control initiatives we put in place at the beginning of the year with continued improvement in each successive quarter. Obviously, the cash balance does not reflect the $5 million in additional Lucid funding shortly after the end of the quarter, nor the remaining $10 million draw available to us under the Securities Purchase Agreement signed in March of 2022, nor other resources that are available to us at the PAVmed and Lucid entity levels. On a pro-forma basis, including the remainder of the securities purchase agreement, and assuming the net burden rate is sustained at this level, our runway is about a year. Furthermore, as cash collections continue to accelerate, as we will talk about in a second, This can further throttle the burn rate for the upcoming quarters.

Vendor payables. They can vary by quarter based upon the timing of receipt of vendor invoices. Although accounts payable is up sequentially, the balance sheet and the 10-Q reflects a decrease from the beginning of the year. Other current liabilities of $1.6 million increase. The largest increase is the accrual for certain insurance renewals that get paid over the next year and has an offsetting amount in the current assets as prepaid amounts. Convertible debt. A net sequential increase of $2 million largely related to an increase in the non-cash charge in fair value adjustments, which increases our offset by debt repayments via conversions to common stock during the quarter. Other long-term liabilities are from capitalized leases related to our lab and office spaces.

Shares outstanding include unvested restricted stock awards as of today equals 120.8 million shares. The GAAP outstanding shares of 119.7 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. So, Slide 17. Slide 17 compares this year's third quarter to last year's third quarter, and similarly for the nine-month totals on certain key items. I trust you will review the information and my comments in light of the cautionary disclosure on the bottom of the slide about supplemental information, particularly non-GAAP information. Revenue for the third quarter largely reflects Lucid actual cash collections for the quarter for insurance reimbursement claims, plus invoiced EsoGuard to the Veterans Administration, plus invoiced amounts for the Veris Cancer Care Platform.

As detailed in our Lucid quarterly call yesterday, we highlighted the discussion that began on our first quarter call in May regarding the major change and upgrade we made to the Lucid's Revenue Cycle Management Company. Recognized Lucid revenue of $783,000 substantially reflects cash collections in the quarter versus the pro forma revenue of about $5 million for the submitted claims of nearly 2,600 tests. As mentioned in the Lucid call yesterday, fourth quarter collections so far are trending 33% higher. The third quarter Veris revenue reflects the initial patients equivalent to about 98 patient months put on the platform for each of the first two onboarded cancer care centers during initial customer acceptance processes that included validation, customization, and integration with the respective EHR systems.

Generally a heavily controlled and very intense pressure testing of the platform as it relates to clinicians relying upon the Veris platform information and the speed of connecting patients and clinicians and the ability to effectively communicate with an update the client's electronic health records and other patient care related systems. Both clients are reporting they are quickly cash flow positive on the platform. Lucid revenue recognition. A key determinant is the probability of collection. And therefore, due to the fact that we are in the early stages of our reimbursement process means revenue recognition occurs when the claim is actually collected versus when the patient report is invoiced and submitted for reimbursement. As you'll see in our 10-Q, this is called Variable Consideration, the jargon of GAAP’s ASC 606 Revenue Recognition Guidelines, and presently there is insufficient predictive data to recognize revenue when invoiced.

As for the Veris revenue, we expect to continue to recognize revenue on an as-incurred and as-invoiced basis subject to normal GAAP rules. Some comments on GAAP and non-GAAP OpEx, as well as net loss. The presentation shows year-over-year comparisons, but I will also go through sequential changes, which are more indicative of where we are heading in the upcoming quarters. Our third quarter sequential OpEx on both a GAAP and non-GAAP basis are not only flat, but within a few dollars of each other. The year-over-year OpEx comparison shows an improvement in OpEx by about 30% for each of the GAAP and non-GAAP measures, a direct reflection of the cost controls we put in place the beginning of the year. Our third quarter non-GAAP loss per share is $0.09, a decrease of a $0.01 from the second quarter and an $0.08 improvement from the loss of $0.17 in the prior year third quarter.

On a GAAP EPS basis, non-cash charges accounted for approximately $0.7 per share in the quarter, including approximately $0.5 per share related to the expenses from the convertible debt. If you were to normalize the loss by adding back the effect of the net convertible debt expenses, the GAAP EPS improved by $0.2 year-over-year for the quarter and improved $0.27 year-over-year for the year to date. Slide 18. Slide 18 is a graphic illustration of our operating expenses as presented in detail in our press release. Other than the comments already pointed out on OpEx about the relatively flat sequential amounts and the reductions year-over-year, there is nothing really remarkable in the sequential piece parts of OpEx with only relatively minor pluses and minuses between the components of OpEx. It is noteworthy to point out, as I did yesterday on the Lucid call, that the pro forma marginal cost of revenue validates the model of nearly 90% Lucid margins for the next patient test walking in the door.

As a reminder, the cost of revenue primarily consists of Lucid lab supplies, fixed lab facility costs, with a much smaller amount attributable to the delivery costs for the Veris Health Cancer Care platform. Also worthy of repeating, some reimbursement stats as mentioned on the Lucid call yesterday. Since the new revenue cycle manager to Quadax took over in mid-June, 5,000 claims representing approximately $10 million in pro-forma revenue have been submitted for reimbursement. About 70% have been adjudicated, 30% are pending. Out of the 70% that have been adjudicated, about 39% resulted in an allowable amount by the insurance company with a mean average of $1,863 per test, nearly the Medicare rate. Of those denied, about 58% require either additional information or are deemed not medically necessary or require a prior authorization.

About 36% were deemed to be non-covered. With that, operator, let's open it up for questions.

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