Good morning, and welcome to the Lucid Diagnostics Third 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. [Operator Instructions] Please note that this event is being recorded.

I would now like to turn the conference over to Matt Riley, Lucid Diagnostics' 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. Lishan Aklog, Chairman and Chief Executive Officer of Lucid Diagnostics, along with Dennis McGrath, Chief Financial Officer of Lucid.

The press release announcing our business update and financial results is available on Lucid'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 statements made.

Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission.

For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors in Lucid's most recent annual report on Form 10-K filed with the SEC and any subsequent updates filed in the quarterly reports on Form 10-Q and subsequent forms 8-K.

Except as required by law, Lucid disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics. Take it away, Lishan..

fully-contracted CYFT pre-cancer testing events concierge medicine programs and employer markets. So let me provide some details on each.

On the fully-contracted CYFT pre-cancer testing events, we will now focus our efforts on securing agreements with self-insured entities, including employers, the unions, particularly firefighter unions, and municipal departments to drive contractually guaranteed revenue.

This initiative follows our first major successful directly contracted event, where approximately 200 Fort Worth Fire Department firefighters received EsoGuard testing in partnership with their medical service provider, Front Line Mobile Health.

We designated an established senior member of our commercial team to focus exclusively on building this pipeline of fully contracted CYFT events, and we really look forward to some near-term wins with that. Next, let's talk a little bit about concierge medicine. This is a new area for us.

The concierge medicine sector is rapidly growing nationwide and offers patients enhanced access to physicians and personalized care for an annual fee. Patients in these concierge medicine practices, they routinely seek cutting-edge technologies such as EsoGuard.

We've hired a new Senior Director of Strategic Partnerships for Concierge and Executive Medicine, a highly successful individual who comes to us from GRAIL, where the concierge medicine program has been very successful in offering new technologies such as EsoGuard.

She brings extensive relationships in the sector and has demonstrated success at driving revenue through this -- from this sector. Next, let's talk about employer markets. We have had some activity in this space, but we're pushing much harder on it moving forward.

Over half of the patients in the United States are insured under self-funded plans, including through their employers, unions and other entities. These plans are typically established through a network of health and wellness program brokers who seek to offer clients value-added services such as EsoGuard.

And we've had good contact and good partnerships with these brokers over the past couple of quarters. We've now hired a new Senior Director of Employer Partnerships, also someone who had -- who brings extensive experience from GRAIL, where she successfully introduced multi-cancer early detection tests to employers and brokers.

To close the loop, again, the reason we're really excited and feel like we're at a moment in time for Lucid is that we're pushing hard to use the data that we've now completed to advance our CMS coverage efforts with MolDX and these programs that are designed to drive direct contracted revenue. And so with that, let's pass the call on to Dennis..

Thanks, Lishan, and good morning, everyone. The summary financial results for the third quarter were reported in our press release that has been distributed.

On the next three slides, I'll emphasize a few key financial 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. With regard to the balance sheet, cash at quarter end September 30 was $14.5 million.

Last Friday, we gave notice to the convertible debt holder that the company is exercising its right to redeem the remainder of the outstanding note. To finance this payoff, Lucid has entered into convertible note purchase agreements with certain accredited investors that exceed the redemption price.

The majority of the new investment is from existing preferred shareholders, which all have a long-term view of the company. We expect to make the payment to the existing convertible debt holder no later than November 22, which is immediately after the expiration of the minimum 10 trading day notice period.

During this window, we expect to close on the purchase agreements. The net proceeds to the company, less the payoff amount, is subject to change depending in part on whether the existing debt holder converts any additional amounts of the debt between now and the payoff.

However, with the current indications of interest minus the current payoff amount, we expect to increase our cash runway by more than an additional quarter, which puts us much closer to a Medicare approval.

The terms of the replacement convertible debt are detailed in our related 8-K on the topic, but generally reflect a five-year maturity, interest only at an annual interest rate of 12%, a voluntary conversion price of $1 with no conversions permissible for six months.

The company can force conversion to common stock once the stock hits $10 per share for a minimum amount of time.

The note is fully collateralized by the assets of the company as well as a few other provisions, including dilution protection, Board representation, participation rights, change of control acceleration and other affirmative and negative covenants that are customary for a security of this nature.

The quarterly burn rate was $10.4 million, which is in line with the average burn rate for the four preceding quarters of $10.6 million. The burn in the third quarter included $7.3 million from ongoing operations, which is in line with the previous quarter and $3.1 million from the quarterly MSA.

We disclosed in the 10-Q that our ability to fund operations beyond one year from today is largely dependent upon how revenues ramp over the next four quarters, which is dependent on how reimbursement landscape for both government and private health insurers continues to improve.

Additionally, our direct contracting efforts with self-insured employers the ramp of concierge medicine, which are cash pay accounts and/or corporate finance activities can work to exceed that threshold.

Included in other current liabilities is the $10.2 million fair value of the senior convertible debt, which reflects a sequential quarterly decrease of $1.1 million. During the quarter, the company issued approximately 2.1 million shares.

Subsequent to the quarter end in the month of October, the company issued 3.8 million shares in satisfaction of conversion notices from the debt holder reflecting a principal reduction of approximately $2.5 million. Shares outstanding including unvested restricted stock awards as of last week are approximately 59.3 million shares.

The GAAP outstanding shares as of September 30 of 51.6 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested restricted stock award amounts.

At present PAVmed continues to be the single largest shareholder of Lucid Diagnostics with ownership of approximately 53% of the common shares outstanding. As of September 10, 2024, PAVmed no longer has the controlling voting or controlling financial interest in Lucid, but PAVmed is still significant at about a 40% voting interest.

As you're aware, Lucid's financings earlier this year included the issuance of a series of voting convertible preferred securities whereby the preferred shareholders are significantly incentivized to delay conversion of their preferred shares into common shares until 2026 namely the second anniversary from closing.

If all of the preferred shares outstanding were converted to common shares as of today there would be an additional 51.6 million common shares outstanding. With regard to the P&L, this slide compares this year's third quarter to last year's third quarter on certain key items.

I trust you will review the information and my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information particularly non-GAAP information.

Revenue of approximately $1.2 million for the third quarter is about 20% higher sequentially compared to the two previous quarters and reflects a 50% increase over the prior year third quarter. The amount reflects actual cash collections for the quarter plus approximately $185,000 in direct contract billings.

Test volume at 2,787 tests for the quarter represent almost $7 million in submitted claims at our $2,499 ASP. As Lishan mentioned with a record number of tests in the month of October, the trailing three-month total of approximately 3,500 tests is the largest three-month total since the beginning of the company.

Given there is a number of new investors joining us for this call, it's worth repeating what we've communicated in the past quarters about revenue recognition. A key determinant in how revenue is recognized at this point in our reimbursement journey is the probability of collection.

Therefore due to the fact that we are in the early stages of our reimbursement process, which means revenue recognition for claims submitted for traditional government or private health insurers will be recognized when the claim is actually collected versus when the patient report is delivered invoiced and submitted for reimbursement.

As you'll see in our 10-Q, this is called variable consideration in the jargon of GAAP's ASC 606 revenue recognition guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring physician.

For billable amounts contracted directly with employers and that are fixed and determinable will be recognized as revenue when our contracted service is delivered. Generally that means when the report is delivered to the referring physician.

Our non-GAAP net loss per share of $0.20 is flat sequentially, and in line with each of the last four quarters plus or minus $0.01 between each of the last four quarters, with an average of $0.21 per share. Our GAAP EPS non-cash charges accounted for approximately $0.05 per share.

With regard to operating expenses, this slide is a graphic illustration of our operating expenses after eliminating non-cash expenses for the periods reflected.

Total non-GAAP OpEx is $11.3 million for the third quarter of 2024 and reflects a $600,000 increase sequentially, including approximately $300,000 for increased clinical research expenses and $300,000 in G&A expenses.

Cost of revenue primarily consists of EsoCheck devices, lab supplies and fixed lab facility costs and is in line with the last several quarters. Let me close with a few reimbursement highlights for the third quarter of this year. In the third quarter, we billed about 2,800 tests reflecting just under $7 million in pro forma revenue.

During the third quarter, we collected $1 million from traditional reimbursement claims. Of that amount collected, about 35% was from claims submitted in the current quarter about 45% from claims submitted in the previous quarter and the balance from claims submitted more than six months ago with the longest dated item nearly 16 months ago.

During the third quarter, we submitted nearly 2,800 claims. That represents just under $7 million in pro forma revenue. About 46% have been adjudicated, 54% are pending. Out of the 46% that have been adjudicated, about 31% resulted in an allowable amount by the insurance company, with an average of about $1,621 per test.

Of those denied, about 34% are deemed not medically necessary or require a prior authorization. Additionally, about 23% were deemed to be non-covered. One last thing, I want to point out, before opening it up to Q&A. The press release provides an update that was not ready in time to make the 10-Q cutoff yesterday afternoon.

Through the evening last night, we received the last subscription agreements that were expected, but delayed due in part to travel of one of the participants. The auditors required us to disclose the amount of cash actually received at the point of the 10-Q cutoff, which is mid-afternoon for XBRL compilation.

However, there is more time flexibility, with the press release that was published this morning. The press release will also appear as an exhibit to an 8-K that will be filed with the SEC as a formal record of the update. So in total, we have in hand $21.75 million of subscription agreements.

The investors will be wiring funds over the next couple of days. We expect to make the payoff of the existing note. no later than the end of next week once the notice period has expired. We expect to increase our cash by about $13.2 million, net of the payoff which on a pro forma basis including the September 30 cash, puts us about $28 million.

At the current burn rate, that's nearly three quarters of runway. With that, operator, let's open it up for questions..

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Our first question comes from the line of Kyle Mikson from Canaccord. Your line is open..

Hi, Kyle..

Hi, guys. Thanks for the question. Good to see the increase in ASP this quarter. But on that note though like, the sequential decline in test volume was interesting. Maybe there was something that was inflating the results last quarter that caused it to look like a decline.

But do you want to just walk through, what happened in the third quarter like the summer month of September that caused that kind of a decline because it was pretty material, 11% quarter-over-quarter. So I just wanted to start there. Thanks..

So interesting, Kyle, that July was about 700 tests and October was double that amount. So if you look at August and September and October, it's a record total. And so in July, you have fewer large events because of the summer period, but picked up pretty dramatically through August and September. And November is off to a very good start as well..

Yes. So, really nothing material Kyle. This is -- we've -- I think as we said before we've kept our sales team headcount flat to down. And this is sort of where we would expect our numbers to be. Last quarter it was up. This was a bit down. Next quarter this month looks great.

It's all sort of within the range that we expect as we now start pushing hard on the direct contracting side..

Okay. So, I mean -- that was great. If October had like 1,400 claims or so, that would be roughly half of what you did in the second quarter of this year.

So, is it safe to say that the fourth quarter is going to be like a record volume quarter for Lucid?.

I think you have to temper that by the fact that the tail end of the quarter starts to have some holiday periods. We saw last year some of the large events tailed off because of the holidays.

So, you have a baseline of 2,500 to 3,000 tests on a quarter-by-quarter basis and that can be additive by some of these large events which give a little bit more choppiness to the predictability of it.

But the bottom-line is the adoption is continuing to be validated and expanded by some of the additional channel -- sales channels that Lishan outlined..

And the pipeline is robust. The CYFT pipeline is pretty robust.

And so yes I think again I'd sort of just reiterate this is -- yes, I would consider this sort of a stable to overall modest little increases, which is exactly how we've been positioning ourselves to maintain our operating expense where it is as we move towards recognizing broader reimbursement and recognizing a greater percentage of this test volume being paid through direct contracting..

Yes. So, bottom-line is the first six, seven weeks of the fourth quarter are very encouraging in terms of the results so far..

All right, great. That sounds promising. And then separately on the recent kind of announcement to further push or penetrate into the concierge medicine market with some new folks from GRAIL and so forth.

So, that's super interesting kind of non-traditional non-conventional way to do this type of like almost like wellness screening because I think you typically take this BCP kind of effort I guess or kind of call point.

But this is a good market obviously right? So, can you just talk about the historical sort of penetration and success that you've had in the concierge medicine market? And then maybe like why now there could be like an inflection in that market for you? And why that why it really like meshes well with your type of screening?.

Yes. So, it's a great question. So, as I mentioned the concierge medicine side of this is new. We have done some -- we've had some activity on the employer market side with self-funded entities as well as working and establishing our network of brokers that work to add EsoGuard as a covered benefit within brokerage plans. So that's moving forward.

We're actually getting -- we've been -- prior to this initiative, we've been getting -- we've established some success at getting amendments to health and wellness plans that include EsoGuard as a benefit. The concierge medicine pathway is actually quite new -- is new for us entirely new for us.

And it's really just been a result of us sort of seeing the success of other companies at putting forward new groundbreaking technologies where there's a real appetite for that in the concierge's medicine sector. That's a rapidly expanding sector. The timing of all of this is related to the fact that it's really related to our data.

So, we've been pushing on the employer market side but this sort of acceleration of these efforts and bringing in people with direct experience and success from other companies who've done this is really linked to the fact that now we have a strong package of data.

When you call on concierge medicine the initial engagement is fundamentally not that different than when we call on traditional primary care physicians. We have to make our case. We have to show our data and show the value of our test.

The way this sector works is that they -- the physician the concierge medicine physicians are looking for these kinds of technologies to offer to their higher-end client patients who pay out of pocket for these kinds of tests and they've had a proven track record of getting patients to do so.

So, we really look forward to starting to see some traction in this space..

Okay. One last one on that point.

So, is it fair to say that your past work with employers health systems the test centers all that that actually helps you succeed I guess in the concierge market?.

Absolutely. Yes. The -- as I mentioned the initial engagement is no different. So the folks that right now are focusing on concierge medicine their training and the way we go about talking to physicians -- physicians are physicians at the end of the day, is identical. And the groundwork we laid for that is definitely going to help us.

There are just some nuances about how you actually structure those engagements that are unique to the concierge medicine side.

The other part which of course is critical in all this is the infrastructure that we've established on the cell collection side of things, right? So we have a completely well-oiled machine right now in getting patients tested getting the cell collection performed and doing so either through our physical test centers but as we've talked about before increasingly through having our clinicians actually come to the physicians' offices on a regular basis and do the testing.

So we were able to offer that to these concierge medicine practices as well as to larger networks. These concierge medicine practices are growing. There have been roll-ups that have large, large numbers hundreds of physicians within this -- within their infrastructure.

So the infrastructure that we've put together on cell collection is obviously critical for that..

Okay.

And then does the pricing in that market work more like the commercial market like you have a negotiated rate? Or is there like a bundle? Is it volume based? How does payment and pricing work in that market?.

You establish a rate with the practice or the network practice and that's the rate -- and that's the rate that the patients pay..

Perfect. That sounds great. Thanks a lot. Appreciate it..

Yes, thanks, Kyle..

Our next question comes from the line of Mark Massaro from BTIG. Your line is open..

Hi, Mark..

Hi, guys. Thank you for taking the questions. Great updates. I appreciate the color on October and November volumes. Things are obviously moving in the right direction. I wanted to just clarify the -- maybe Lishan your commentary about the EsoGuard BE-1 study accepted for peer-reviewed publication in the American Journal of Gastroenterology.

Is it fair to say that that publication is on track to hit maybe by the end of this calendar year? And I would assume that you would be submitting this to MolDX immediately after that.

Can you just give us a sense for timing?.

Yes. No -- so it's this is from this point it's a formality. It's been accepted for publication. I believe the PDF of the sort of the unformatted will be available on their site soon. We're going through the usual formalities of getting the formatting before it will be posted on their website as being published very, very soon.

And so we are poised now having met with MolDX having this particular paper now done and accepted to file our data and our request for reconsideration of the LCD in the coming days..

Okay. Great. Can you give us a sense for what your funnel looks like in the CYFT pipeline? You characterized it as robust. However, I recognize that December gets pretty cold. And so I'm just thinking about weather and seasonality and also fewer days due to holidays.

Just give us a sense for maybe how many events you are planning to host in Q4 and what your runway might look like into 2025?.

I think Mark we're going to limit it to say that usually these Check Your Food Tube events are scheduled out three months and four months ahead. And except for the holidays in December our teams have their hands full over that period of time. So we'll update that as we go forward. But let's leave it at that. It's fairly robust.

And rather than giving that prospective information we'll update it the next time we talk to the Street..

Okay. That's helpful. And then maybe last one for me. Yes, the concierge medicine is certainly interesting. Maybe just to clarify because I know that you've done a nice job of holding your ASPs, your $1,938 Medicare price. You've done a nice job of holding with commercial health plans.

Can we look at that Medicare price as a potential proxy when you're going to sell into concierge? Or do you think because it's full self-pay there might be a discount to that?.

We don't know yet. We come in with a – our list price is $2500. So that's our starting point. And this will be charged to patients. So I think it's a little bit too early to say but we are – we think the pricing is going to remain robust. Our margins are going to remain robust.

And obviously, the opportunity to have guaranteed payment within the sector is very attractive to us. So just – I think I'll just leave it at that. Our pricing is – we think the pricing is going to hold up..

Okay. Great. Thanks for the reminder on the list price. That’s it for me. Thanks, guys..

Hey, thanks, Mark..

Our next question comes from the line of Anthony Vendetti from Maxim Group. Your line is open..

Thank you. Hey, Dennis. Hey, Lishan.

How are you?.

Good morning..

Great..

So I just wanted to dig in a little bit more on – it sounds like you're just about ready to submit the data package for Medicare coverage.

What is that time line for that? Then once you submit it, what is the expected time line for a decision and then your plan to prepare for the eventual coverage decision, sales force all that?.

Yes. So obviously, as with anything like this, whether it's FDA or CMS, there's no assurances as to how – we can't give sort of hard projections with regard to the time. But as I've said before, we've been deeply engaged with MolDX. We have a high level of confidence in our data.

We understand that this reconsideration of the LCD is fairly straightforward because the work that had been done in the original LCD is very comprehensive. And we have no qualms with regard to how that's written. We're just looking for coverage for our own test. So I will just kind of leave it at we're very optimistic.

We think it's likely to be a first half event for next year. And we'll know then. We're just really happy to have reached this point to have the data to be able to get this thing filed.

And we're entering into this with a lot of optimism and confidence in both the data and in both our efforts to figure out how to precisely navigate this process with MolDx..

Okay. And the concierge option I guess concurrent with this submission is there – has there been decisions on pricing that? Would that be different than the current pricing for coverage decisions? Can you delve into that a little bit? Or is it....

Yes, yes. I touched on this a little bit with Mark but we're not – this doesn't really have anything to do with the coverage side of things, right? These are you walk in, you engage with a practice.

You first make the case with regard to their understanding of the value of the test and their excitement about offering this test to their cash-paying patients and you negotiate a price. And as I said to Mark, our benchmark, our list price is $2500. And it's a negotiation to determine at what price they feel their patients will pay.

This is a very select group.

The concierge medicine practice is one where people are very used to not simply paying sometimes a substantial amount on a regular, monthly or annual basis just to be part of the practice but for added services, whether it be tests like this or the GRAIL test or other comprehensive cardiac evaluations and things like that.

So that's how this ecosystem works. And we'll start at $2500 and we'll make a – we'll end up with sort of contractually arranged pricing that the practices will pass on to their patient. And it doesn't – this doesn't require – remember, this is direct pay.

So this doesn't require us to submit claims and to work through the revenue cycle management process or all of the other hoops you have to jump through traditional reimbursement. This is effectively cash pay by the patients..

Great. Excellent. Thanks for the update. Appreciate it, Lishan..

Thanks, Anthony..

Our next question comes from the line of Mike Matson from Needham. Your line is open..

Yes. Hey, guys. So I guess first just when and if you get Medicare coverage probably not at this point, how does your marketing strategy kind of go-to-market approach change? I mean, I know you're deliberately targeting places that you're likely to get paid now but -- and doing the CYFT events and stuff.

But are you going to do something differently when you get Medicare coverage?.

Yes. So, about 25% of our volume right now is Medicare population, and you sort of hinted that we have the ability with our CYFT events to target folks, but really not so much based on payer right now. The epidemiology would suggest that up to 40% or more of the target population here are Medicare population.

So, we certainly will have the ability upon Medicare approval to direct our resources towards that.

But obviously -- and drive -- perhaps drive that percentage higher and certainly drive the proportion of our revenues that come from Medicare to be higher targeting retirement villages or population centers that have higher than average ages and so forth right? So -- but as a key reminder, this is not just about Medicare, right? Having Medicare coverage is the ticket or the entry or the gateway to finalizing ongoing conversations with commercial payers through their laboratory management groups like Evercore and others that do technical assessments on behalf of the larger plans.

So, it's really a stepping stone towards getting broader commercial coverage. And we certainly would expect that to accelerate immediately after -- those efforts to accelerate and for us to start getting some runs across the plate after we secure Medicare coverage. So it's a combination of the two..

Okay. Yes, got it. And that kind of leads into my second question, which maybe you already partially answered.

But just the dossier or data package, you're putting together for MolDx, do you think that that's sufficient for private insurers? And then to what degree do you think those private insurers sort of factor Medicare coverage assuming you get it into their own coverage decisions?.

Yes. I mean, we obviously -- we have a lot of confidence in our data. We do believe it's sufficient for both Medicare as well as the commercial payers. And as I sort of already mentioned that it's not like we're not having active engagements or discussions on policy and so forth with the commercial payers right now.

But having Medicare coverage in your pocket certainly has a big impact on those conversations..

Okay. Great. Thanks..

Okay. Thanks, Mike..

Our next question comes from the line of Ed Woo from Ascendiant Capital. Your line is open..

Hi. Ed..

Yes. Thank you for taking my question. My question is on the geographic dispersion of the test.

Have this been pretty uniform? And is there certain areas of the country where you guys are more stronger?.

Yes. There are certainly areas where -- just as with any commercial ramp you get areas where you develop traction as it relates to your personnel and so forth. And our team -- we've kept our team flat, but the team has been pretty dynamic in allocating resources in various locations.

So, we're strong in California in Texas and Florida, but also in other parts of the country. We have -- we've talked about this before, I didn't mention it today that there are states that have biomarker legislation that have state legislation that mandates coverage for biomarker tests.

And we've certainly taken that into consideration as well as we've looked to our geographic distribution..

Great. Well, thank you for answering my questions and wish you guys good luck..

Thanks, Ed..

Thanks, Ed. Appreciate it..

There are no further questions at this time. I would now like to turn the call over to Dr. Lishan Aklog for closing remarks..

Hi, so with that thank you all for your time and attention this morning. I think it should be clear that this is a moment in time for our company and we have a lot of exciting things to look forward to in the coming weeks and months. So, make sure you keep abreast of our progress via news releases and periodic calls such as this.

And the best way to do so is to sign up for our e-mail alerts on the Lucid Investor Relations website and to follow us on Twitter, LinkedIn and our website. So, thank you everyone. We really appreciate it. And have a great day..

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect..