Lucid Diagnostics Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
March 26, 2024

There are 8 speakers on the call.

Operator

Good morning, and welcome to the Lucid Diagnostics 4th Quarter and Full Year 2023 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. Please note this event is being recorded. I would now like to turn the conference over to Dennis Fakrat, Lucid Diagnostics' Chief Financial Officer.

Operator

Please go ahead.

Speaker 1

Thank you, Luti. Good morning, everyone. Thank you for participating in today's Q4 full year 2023 Lucid Diagnostics business update call. The press release announcing our business update for the company and financial results for the Q4 and the year ending December 31, 2023 is available on our Lucid website. Please take a moment and read the disclaimer about forward looking statements in the press release.

Speaker 1

Business update, the 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, description of these and other important risk factors and uncertainties that may affect future operations, see Part 1, Item 1A entitled Risk Factors and Lucid's most recent annual report on Form 10 ks filed with the SEC and subsequent updates filed in quarterly reports on Form 10 Q and any subsequent filings on Form 8 ks. 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 events, conditions or circumstances on which the expectations may be based or they may affect the likelihood that actual results will differ from those contained in the forward looking statements.

Speaker 1

Like to turn the call over to Doctor. Lishan Aklog, our Chairman and CEO of Lucid Diagnostics. Lishan?

Speaker 2

Thank you, Dennis, and good afternoon, everyone. Thank you for joining our quarterly update call today. Before proceeding, a couple of things. First, I'd like to apologize, I have a bit of scratchy throat. I'm feeling under the weather, so sorry about that.

Speaker 2

And I'd also like to thank our long term shareholders for your ongoing support and commitment. Hopefully, our team is singularly focused on driving the Lucid enterprise towards its massive commercial potential and to enhance our long term shareholder value. I'm very pleased with the excellent progress Lucid has made on multiple fronts during the Q4 and the start of this year, including strengthening our balance sheet with an $18,000,000 financing from longstanding fundamental shareholders. We saw solid revenue growth on stable test volume, improving allowances and stable out of network pricing. Our CYFT program, health fair events is thriving.

Speaker 2

Our now robust clinical validity and clinical utility evidence based poised to drive positive medical coverage and what I believe is, at line of sight to Medicare coverage. And I'm also particularly excited about our accelerated direct contracting initiatives. So just let me just offer a few highlights and then I'll do a quick overview of the company for those of you who are new. On the commercial execution side, the 4th quarter revenues were just a hair over $1,000,000 That's up 33% quarterly and 829 percent annually. EsoGuard test volume was 2,200 tests.

Speaker 2

I'll talk a bit more about those trends later. Our high volume health fair CYFT testing events continue to gain traction and we're fully booked right now through July. We have active eCR testing programs now with over a dozen strategic accounts, which include health systems, academic centers and other related entities. And we have engagements with several dozen more. Our revenue cycle management process continues to deliver solid results for out of network payments.

Speaker 2

About 50% of adjudicated claims are now coming back as allowed with stable payments averaging about $1800 Next slide. Some key strategic accomplishments, as I mentioned, the we strengthened our balance sheet was the $18,100,000 preferred stock financing. We've had a significant expansion of our clinical validity or CV and our clinical utility or CU data to support broad EsoGuard Medical and policy coverage including engaging reengaging with a multi exon for our Medicare for the Medicare side, which I'll talk about a little bit later. We have now 3 clinical validity studies that document excellent EsoGuard sensitivity and negative predictive value. We have 3 clinical utility studies that document near perfect concordance with physician decision making.

Speaker 2

Using that data, we're now starting to hold meetings. We've held meetings now over the last couple of months with medical directors of major commercial payers to now for the first time formally request positive medical policy determination for EsoGuard. Similar to those efforts, we held a Blue Cross Blue Shield Association of America webinar that was intended by dozens of medical directors to advocate for EsoGuard coverage. And then finally, we'll talk a bit more about this later. We've launched our direct contracting program with EsoGuard now offered as a benefit and this as a means to drive contractually guaranteed revenues.

Speaker 2

So just a few intro slides for those of you who are new or to update you on our company overall. Lucid is a commercial stage cancer prevention medical diagnostics company. We're focused on early precancer detection to prevent esophageal cancer deaths in targeted at risk patients. Next slide. The EsoGuard esophageal DNA test is the first and only commercially available test that's capable of serving as the widespread screening tool to prevent these deaths through the early detection of esophageal pre cancer.

Speaker 2

Slide. So now we have as I mentioned, we have really solid clinical validity data that documents EsoGuard's performance. This is a bit of a summary slide here. EsoGuard's in blue and comparing it to sort of the standards that we see for performance with other tests, particularly in the colorectal space with Cologuard and the new blood test, Guardant. Cancer sensitivity remains extremely high, as does precancer sensitivity and early precancer sensitivity.

Speaker 2

And those two numbers, I'll note are really unprecedented. So to have a 90% pre cancer sensitivity, again, you can note compared to other tests in the space is unprecedented. There is no other molecular diagnostic test that can claim that. And most notably, our early pre cancer numbers also holding in that 90% range. Again, no other tests, molecular tests can detect an early pre cancer with any sensitivity, much less at that 90% level.

Speaker 2

That results in an overall negative predictive value of 99%. So just a 1% false negative rate and an estimated positive predictive value of 30%, which increases the yield of endoscopies between 2 and 3 fold. Next slide. So just two slides summarizing this data. Again, this is the absolute foundation, the backbone of our future is documenting the performance of the study.

Speaker 2

Clinical validity again is the performance of the assay here. I won't go through each detail here, but you can see that we have 3 studies, the original Case Western paper, the BETTERNET study in Cleveland VA. One is published to our preprint and coming soon, we have a manuscript completed for the BE-one study, which is now heading towards posting on preprint and submission for publication. Next slide. Similarly, on the clinical utility side, we have now 3 studies that are published in the peer reviewed literature and form again the foundation of our engagements with payers, commercial payers and will set us up in the near term with Medicare.

Speaker 2

Next slide. The market opportunity here is really fantastic. It's massive. There are absolutely 30,000,000 patients who are at risk, are recommended for pre cancer testing by existing guidelines, which now include non endoscopic biomarker testing such as EsoGuard. We have Medicare payment established at $1938 As I noted, our out of network payments are matching that quite closely at about $1800 so that pricing is holding and that results in an approximately $60,000,000,000 true total addressable market opportunity.

Speaker 2

Our gross margin is 90% at our current volume, so at our current levels of efficiency. Next slide. And our commercial strategy is multipronged. So patients our goal is to provide patients access wherever we can. So we have our own physical Lucid test centers, a backbone, a major pathway for patient access is the satellite Lucid test centers where our practitioners go to physicians' offices on scheduled days and test patients in their offices.

Speaker 2

We also have physician practices, particularly GI practices and other specialists who perform the EsoGuard test using their own staff that accounts for about 30% of our total volume. In Florida, we have a mobile, Lucid test center, a van that can go to physician practices, park in the parking lot, pitch a tent and offer testing on the spot. And as we'll talk about a little bit more, we have our Check Your Food Tube health fair events, which have been focused initially over the past year. We've reached our 1 year anniversary at these health fair type events, and are expanding into other areas as well. Next slide.

Speaker 2

So this slide shows our the progress over the last approximately 3 years with regard to revenue and test volume growth. So you can see revenue has been growing nicely since our transition in the late Q2 to our new revenue cycle management provider, so in the late Q2 of 2023. The test volume growth has stabilized. We think this is likely going to be approximately where things stabilize in sort of the 2,300 to 2,500 range. I will note and remind you that we have not added any salespeople, since the Q4 of 2022.

Speaker 2

So that growth from about 1,000 tests in this 2,400 plus or minus level has been with the same sales force. And as I hinted earlier, we've had increases in productivity. However, we have no plans at this point to expand our sales force until we continue to see some progress on the reimbursement side. So that's our expectation. The Q4, we had 3 weeks that were where we weren't able to do this thing between 2 holidays and 1 week for our national sales meeting.

Speaker 2

And so we feel pretty comfortable that these volumes will hold and will show potentially modest growth over the coming quarters. I did indicate an estimated number for the quarter that's just about to close. Next slide. So a little bit deeper dive on our commercial execution. The Check-in for you to be the Pirate Healthcare type pre cancer detection events remain a significant contributor to our activity.

Speaker 2

You can see on the right there that where these have been heavily focused on firefighters since we've had our first event now just over a year ago in San Antonio. We've had steady growth. We have some very strong pipeline and we're fully booked through July. Right now our rate limiting factor is the number of clinical personnel we have to run these events. And we have a really great demand from entities, particularly the firefighters.

Speaker 2

We're expanding our testing beyond just holding health fair events at firehouses to now targeted conferences. We actually had an event at the National Conference for Firefighter Chiefs and tested several dozen firefighter chiefs on the spot during the conference and other types of symposium. We're increasing the efficiency of these events and the capacity by utilizing Upscript, our telehealth partner. So we no longer have to identify a local physician champion to get one of these off of the ground. We can just jump in and get started with our telehealth partner.

Speaker 2

And really perhaps most importantly is the last bullet here. We're now as we launch these events, we're now initiating contracting discussions in parallel with the planning for the initial inaugural event. And we've found that the leaders are strongly motivated to engage. For example, with the unions, there's very much a firefighter side, strong motivation to offer testing and to show that they're providing something to value and they're focused on cancer prevention amongst their brothers and sisters. And that's been really encouraging and promising with regard to our ability to engage on contracts moving forward.

Speaker 2

As I mentioned last quarter, we've been pushing harder now with our commercial team on strategic accounts. These include health systems, large multi location group practices, academic medical centers. And now we have over a dozen such strategic accounts, including big academic medical centers that are testing, offering e cigarette testing. And these are typically in the context of a structured overall program for, esophageal cancer awareness for GERD and so forth. And we have several dozen that remain in the pipeline.

Speaker 2

On the next slide, the next big, big area for us right now is direct contracting. As we mentioned in our last call, we are getting just getting started with this. We hired a VP of Employer Markets and we actually are now expanding that team. So let me just give a few more details on the next slide of what this is. Next slide.

Speaker 2

So when we talk about direct contracting, we're talking about offering EsoGuard as a covered benefit to drive contractually guaranteed revenue. So this is different than the traditional path. The traditional path being a physician prescribes a test and we submit a claim to the insurance policy and work through work with the insurers to get coverage and payment for that. This essentially bypasses that and we go directly to entities that with whom we can engage with whom we can contract to offer testing as a covered benefit typically within a health and wellness benefit program. And our team that's now about to expand is engaged with this on multiple fronts.

Speaker 2

So there's a whole network of benefit brokers that work with 3rd party administrators to offer benefit packages to employers across the country. And we have now deep engagement with these entities to offer EsoGuard within the benefit packages that these brokers and ultimately the 3rd party administrators are both providing to employers, so to offer Easter Earn as a benefit. A subset of that are self insured entities. So with them, we can actually go directly to those entities. These again involve employers and then entities, other similar entities such as unions, who can offer our test as a service directly for their employees or members, really separate from the benefit process.

Speaker 2

And we're active in that. We previously announced had our first contract there. Testing has proceeded. These testing events are very similar to the Check Your Food Tube events where our team shows up at sites for the employers and offers testing on-site to subgroups of employees or members who are candidates for testing. And then there are other partners that we're working with.

Speaker 2

We had previously announced that we are engaged with the 911 fund that has a large number of patients in the Greater New York area who are to receive treatment for conditions that are related to their exposure during 911. That process there was like to navigate and sort of clerical issue back a couple of months ago, but that process is now back in full swing. We've formally engaged with 1 of their clinical centers of excellence, Mount Sinai, and we look forward to starting to engage and test patients within who are covered by the fund. And there are a variety of other entities, for example, like residential communities, in various parts, particularly in the Sunbelt, where that have concierge medicine practices that again offer, specialized testing, as a benefit for the residents, their community. And we're engaged in several of those right now and look forward to consummating contracts there.

Speaker 2

The way what we offer with this direct contracting are really 3 flavors. One is a direct ongoing contract. So we would basically charge per patient tested under the umbrella of one of these contracts. The second patent model is particularly when it's in the context of a benefit. If I had an offer Usagard as a covered benefit, it's a charge for a lifetime benefit per member, not necessarily those who are tested.

Speaker 2

And then we also are in discussions and several examples of just a service agreement where we charge for a full or half day screening event that's up to a certain number they can handle up to a certain number of patients at the end of the day and those are scheduled accordingly. So that's our direct contracting initiative, big deal. We're pushing hard on this and we really do expect there to be a meaningful contributor to test volume as well as the revenue in the coming quarters. Next slide. So just an update on the entire process by which we submit claims, payments receive payments on those claims and generally pursue in network coverage.

Speaker 2

On the revenue cycle management side, again, this represents out of a payment for out of network claims. And we've submitted now since we made our transition to We're now quite stable at about 80% are getting adjudicated. And of those that are adjudicated, an increasing percentage now a bit over 50% are being allowed. So the claim is allowed, and the average allowed payment is $1800 and we can actually go and collect that either from the payers or ultimately from the patients. We're also working very hard with QuadEx on the appeals process.

Speaker 2

We're starting to yield some wins. We're winning about 25% of our appeals. And there's an entire process by which we're that we're strengthening and optimizing. And that includes, for example, leveraging providers. So, in certain examples, we'll get a dozen or so providers, physicians in the local area to submit to the local payer as part of an appeal to indicate the that this is medically necessary and important for them to cover.

Speaker 2

And we're also working for the first time on a prior authorization program since about 18% of the denials are for lack of a prior authorization. So we're incorporating a streamlined way for physicians to seek a prior authorization. So the big push of course is on medical policy coverage. I mean, it's one thing for us to be collecting and the revenue that we're generating now is on out of network. But ultimately, to take advantage of the full potential here, we need to get a in network coverage at both from commercial payers and Medicare.

Speaker 2

So in the last month or 2, as I hinted earlier, we've held meetings with medical directors of the major commercial payers, names you would recognize, to formally request for the first time, a positive medical policy determination for EsoGuard based on now the data that we have. Now the result of those will be varied and will but at least as it initiates a discussion, either for fortunate, we'll get coverage. If we don't get immediate coverage, then our secondary goal is to get engaged in pilot programs to collect clinical utility data within that particular payer and we have some really good prospects on that. We were really excited just last week that we participated in a Blue Cross Blue Shield Association of America webinar where dozens of medical directors were in attendance and our lead advisor and Head of our Medical Advisory Board, Doctor. Nick Shaheen, who is the lead author of the American College of Gastroenterology guidelines really gave an excellent presentation, making a very strong argument based on guidelines that EsoGuard should be covered by the plans.

Speaker 2

And so that was a very positive engagement. On the Medicare side, we are targeting reengagement with the MultiX program, which is the entity that finalizes local coverage determinations. We are able to operate within the construct of a local a final and effective local coverage determination that's foundational for the category of tests that's in effect. And we are now believe we've collected sufficient clinical validity and clinical utility data to make that reengagement. The timing of that, of our meeting, our pre submission meeting with them is triggered on the publication of one of the key clinical validity studies, the BETTERNET study, and that we expect to happen any day now, in which point we will ask for a meeting.

Speaker 2

Then based on that meeting proceed to a technical assessment submission. So based on what's now very concrete timeline and based on the completion of what we believe is sufficient data to convert the foundational LCD into coverage determination for Medicare. We really do believe that we now have a line of sight to Medicare coverage. And then one final area that's been an area of strong focus is there is now biomarker legislation in over a dozen states where by state statute there is a there's mandatory commercial coverage for certain biomarker tests. And that gives us the opportunity.

Speaker 2

Next slide please. Next slide. So that gives us the opportunity to operate in these states. So these are the 16 states with biomarker legislation, including 2 that are limited to cancer. We believe we and we're getting we're starting to get feedback that we are covered under these states, under this legislation in certain states, and we're going to continue to push hard on that.

Speaker 2

Again, it guarantees mandatory commercial coverage of where this legislation occurs. And by achieving this, we're able to actually work on targeting our resources, whether there'd be a commercial team or other activities in those states. And that's something we're looking forward to yielding results in the next couple of quarters. So with that, I'll hand the reins over to Dennis to provide an update on our financials. So Dennis, take over.

Speaker 1

Thanks, Lee Sean. The summary financial results for the Q4 and the year were reported on our press release that was published last night. On the next three slides, I'll emphasize a few key highlights from the quarter. I'd encourage you to consider those remarks in the context of the full disclosures covered in our annual report on Form 10 ks, which was filed with the SEC last night is available on our website. So on Slide 18 here, you see the balance sheet cash at year end was 18,900,000 dollars We supplemented that balance with the financing that we completed just 2 weeks ago in the amount of 18,100,000 dollars The average quarterly burn rate for last year was $8,200,000 per quarter, as you can see in the statement of cash flows in our 10 ks.

Speaker 1

Earn in the 4th quarter was $6,700,000 from operations and $3,400,000 from pay down of intercompany debt. We disclosed in the 10 ks that our ability to fund operations beyond 1 year from today is largely dependent upon how revenues ramp over the next 5 quarters, which is highly dependent on how the reimbursement landscape for both government and private health insurers as well as successful efforts for direct contracting with self insured employer shapes increases in payment realization of submitted claims and or corporate finance activities. Beyond that, there is nothing substantively remarkable about the remainder of the September 31 balance sheet. However, subsequent to year end, in addition to the incremental $18,000,000 of cash infusion, Lucid settled approximately $4,700,000 in debt to PAVmed by the issuance of approximately 3,300,000 shares of common stock. Shares outstanding including unvested restricted stock awards as of today is 48,200,000 shares, which includes 242,000 shares issued subsequent to year end in connection with conversion notices received from the convertible debt holder.

Speaker 1

The GAAP shares outstanding of $42,300,000 are reflected on the slide as well as on the face of the balance sheet in 10 ks. GAAP shares do not reflect unvested restricted stock awards. With regard to the P and L on Slide 19, it compares this year's Q4 to last year's Q4 and similarly for the yearly totals on certain key items. Trust you'll review the information and comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non GAAP information. Revenue of $1,040,000 for the quarter, a 33% sequential increase over the Q3 and is in line with what was previously previewed.

Speaker 1

The amount reflects actual cash collections for the quarter plus a small amount of invoice EsoGuard tests delivered to the Veterans Administration, plus about $26,000 in initial billings under the direct contract with the Incira Auto Group. The revenue increase reflects about a 9 fold increase over the prior year quarter and about a 6 fold annual increase over the prior year. Test volume at 2,200 tests for the quarter represent just over $5,000,000 in submitted claims for the 4th quarter at our 24.99 standard pricing for the test. For the Q1 of 2024, revenue is tracking to be on par with the 4th quarter. Revenue recognition is a key determinant in the probability of collections.

Speaker 1

And therefore, due to the fact that we are in the early stages of the reimbursement process means revenue recognition for submitted claims submitted to traditional government or private health insurance will be recognized when the claim is actually collected versus when the patient report is invoiced and submitted for reimbursement. As you'll see in our 10 ks, this is called variable consideration. It's 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 are fixed and determinable, they will be recognized as revenue when the contracted service is delivered. Generally that means when the report is delivered to the referring physician.

Speaker 1

Our non GAAP loss for the quarter of $9,900,000 reflects about $600,000 in sequential increase compared to the Q3 and about $700,000 decrease year over year. The increase in the Q4 was related to 3 specific one time events some clinical research costs of about $300,000 mostly related to the events leading up to the published clinical utility studies, $300,000 in sales and marketing and some G and A patent expenses of about 250,000 dollars These amounts were offset by the quarterly increase in revenue. On the next slide, Slide 20 is a graphic illustration of our operating expenses for the periods reflected. Total non GAAP OpEx is $10,900,000 for the Q4 of 2023 and it's fairly flat year over year and increase from the 3rd quarter reflects the clinical research, the one time patent expense and that sales expense that I just mentioned. The cost of revenue primarily consists of EsoCheck devices, lab supplies and fixed lab facility costs.

Speaker 1

The variable cost for each test is approximately $200 They're effectively at 10% to 11 percent marginal cost of sales for changes in test volume quarter to quarter. The non GAAP net loss per share has been relatively flat for each of the last 4 quarters, plus or minus a penny between each of the 4 quarters of 2023. On a GAAP EPS basis, non cash charges accounted for approximately $0.03 per share in the 4th quarter. A little bit more about reimbursement details. So since the new revenue cycle manager products took over in mid June, Wishan has given you some details.

Speaker 1

There were 7,800 claims representing approximately $20,000,000 in pro form a revenue have been submitted for reimbursement either to government or to traditional health insurers. About 82 percent have been adjudicated, 18% are still pending. Out of the 82% that have been adjudicated, about 46% resulted in an allowable amount. That's basically what the insurance company says, we should be entitled to be paid with an average of $18.28 per test. Now out of that amount, it still has to be reviewed with the patient, what's their out of pocket, what's their deductible, which could lower that effect amount.

Speaker 1

But the insurance companies are holding to the general pricing line and all out of network $18.28 that should be viewed very positively in terms of the benchmark Medicare 1938. Of those denied, about 51% required one of three things, either additional information that was about 7% of those denials or deemed not medically necessary, which is a bit puzzling considering that the patients are meeting the guidelines that was 26% of those denials or require a prior authorization, that's 18% of denials, about 29% were deemed to be non covered. So with that operator, let's open it up for questions.

Operator

Thank you. Your first question comes from the line of Kyle Mixon from Canaccord. Your line is open.

Speaker 2

Good morning, Kyle. Hey, guys. Thanks for

Speaker 3

the question. Congrats on the year and the quarter. So just looking at the volume and the I guess like the revenues. So volume decreased quarter over quarter a little bit, maybe 15%. Do you think you can kind of maintain these quarterly levels, but around 2,400 or so claims?

Speaker 3

I guess that makes some sense given the sales force situation. But the and ASP dynamics and metrics going forward given you're now kind of hitting like a nice, kind of stable rate for both of those, if you look kind of progressing nicely, maybe on upper trajectory especially on the ASP side?

Speaker 2

Let me start with volume and then I'll hand it over to Dennis. I think you summarized it well, Kyle, that we've kind of peaking on our productivity of our existing sales force. Again, that doesn't mean that we want to test volume growth, but test volume growth is going to be driven more by other aspects as opposed to our sales force that's calling directly on physicians. So that will be driven by these Check Your Food Tube testing events, which are more efficient as you might imagine in terms of the person power that's required to run an event that can generate 100 or more tests without as much activity on the sales side. And importantly, on the direct contracting side, right.

Speaker 2

So those could yield a significant test volume growth without depending on the productivity and the size of our sales force. So I think you're right. I think we at the current size of our baseline activity, traditional sales and marketing activity, I think these numbers, we expect them to hold. And but we will obviously hope to see growth from the other pathways that I mentioned. I'll let Dennis talk a bit more about the second point.

Speaker 1

Yes. So on collection realization, the trajectory and technical review of the Q1, to the extent it's dependent upon the government and private health insurance that is tied to our sales force, that level should stay relatively flat with acceleration in the second half. The extent that the volume picks up with a direct contracting and again that is not as limited as Lishan just pointed out by the amount of time and selling opportunity of our sales force. There is a multiplying effect with direct contracting. And the fact that payment is guaranteed as part

Speaker 2

of that

Speaker 1

contract, not dependent upon independent third party insurance companies that is not as predictable. That will increase realization as we move forward. So if you just look at 2 data points, 2nd quarter and the 4th quarter where volumes were about the same in terms of test volume, the increase in realization is significantly higher from those two periods. That's a reflection of the improvements with our revenue cycle manager and the appeals process is just starting to take root. And in those examples where the appeals have been submitted, we are being successful with them.

Speaker 1

That will also help with the realization. So we see as a general statement on the 3rd party insurance collection where revenues depending upon actual cash collections. Timing is an issue there in terms of how quickly from a submitted claim do we actually get cash and that's less predictable for us. Kind of maintaining that as a view of fairly flat as the direct contracting picks up. The realization will obviously go up because again the payments guaranteed and we can recognize revenue when we deliver the reports or deliver the service that's been contracted for, which will help speed the revenue ramp.

Speaker 1

We see all of them converging in the second half, having greater momentum. So hopefully that gives you enough color on that particular topic.

Speaker 3

Yes, that was fantastic guys. Thanks so much for that. And then just on the Checkifu Tube events, clearly those are going pretty well. Originally, some of us may view that as like a risk creating some lumpiness with the volume and so forth. Maybe like there was some concentration there.

Speaker 3

I mean you have like a 2 to 3 month backlog and it's pretty nice visibility and you're expanding. Is it fair that it's definitely not like just for lack of a better word like an artificial or like inflated at this point? How does that evolve over time? How could that funnel into like deeper penetration among the clinician base over time?

Speaker 2

Yes. So that's a great insight, Kyle. And definitely, yes, I think in the early stages when we had our first event and there were sort of 400 patients who were tested over 2 weekends representing what was that 20% of our, or even more of our volume for that quarter. Certainly there was an opportunity for me longer. That's just not true anymore.

Speaker 2

So we're doing dozens of events, smaller events, larger events and everything in between. And right now we're limited. The demand is high and we're really limited by clinical team that we have a certain number of clinicians, nurse practitioners, nurses and other device administrators. And we are sort of the efficiencies to which we're utilizing them in an efficient way, but getting them around to these events does limit we have a sort of cap on how many we can do in a given month. So I think it's correct for you to perceive this as just another source of organic volume and growth and the ability to grow that volume is going to I guess what I would say is the way our willingness to invest in more clinicians to drive more events will be directly related to our success at converting these events from we go do test 100, 200 firefighters, and submit for their insurance policy and we're sort of at the mercy of the claims process there.

Speaker 2

As we convert from that process, which has been how we've been focused in the early stages over the last year to, as I mentioned, now we are at the same time, sort of typical scenario is we engage with the fire department. Now they're soliciting us because there's good visibility at the conferences and so forth. And we talk at the unions are self insured. And those dialogues are going really well. The leaders, particularly the union leaders are motivated to offer a service to their personnel.

Speaker 2

They're very focused on cancer prevention and particularly in the firefighter group. And so as we start seeing really similar in many ways, Kyle, as we start seeing increases in realization from realization of revenue from these events, then we'll be justified in investing in more personnel to drive our capacity to do these events.

Speaker 3

Okay. Yes, that was great. That was a little good color there. Maybe just finally, I'm wondering about some timelines for the clinical validity studies, particularly maybe the VA study, like I know pending publication everything, but I mean just like the relevance to that, I feel like that's kind of an important, like it's a good proof point. And with BE-one hundred and one and BE-one hundred and two, I guess, 101 is like kind of close to being announced everything with 102 is a little bit further back.

Speaker 3

So what's yes, just like are these important? What's the timeline and like when do we kind of expect some color?

Speaker 2

Yes. Why don't I talk about the timelines relative to our plans with MolDX. So on the clinical study, there's the original STM paper. There's the BETTERNET study, which has released data. It's on preprint.

Speaker 2

It's gone through multiple cycles of review at a leading journal and we really expect that to be clear for peer review publication very, very shortly. We're just kind of waiting on what we think is the last round of responses to reviewers comments. As soon as that is published online, then we will request a meeting with MolDX. So that's what we believe that that is sort of the linchpin gating item for the publication of that clinical ruling study. You mentioned the VA study as being a really important complement to that, which it got posted on preprint, it's been submitted.

Speaker 2

We're not going to wait for that for being for peer review. I expect that there's a good chance that when we have our meeting, it will either be in peer review and certainly for any technical by the time we get around to doing a technical assessment submission, it would be peer reviewed. The key thing I think you were hinting at with the VA study, it's our first study in a screening population. So the original STN paper as well as the Betanet study were both case control studies and you always want to be able to show that you can replicate your performance in the actual intended use population in a real world situation where you're taking people off the street who've never had endoscopy before that are categorized as having at risk and recommended for screening by guidelines and showing that you can actually identify disease with a high performance, with a high negative predictive value and really good solid positive predictive value. So that is on preprint and has been submitted and we'll wait for that to be published.

Speaker 2

On the clinical utility side sorry, the remaining clinical related studies, the next in line is the BE-one study, which is our study in a screening population. That study, the manuscript is complete. The data is, have been tabulated. I'll give a preview and that the data is nearly identical to the VA study. So both studies in a screening population have really nearly identical and otherwise excellent results.

Speaker 2

So that manuscript is being finalized. The lead author is Doctor. Shaheen. And so we're just getting final sign off on that and it should be posted on pre soon and submitted for publication. Again, we're not going to wait for that, but the 2 screening population studies will be an important supplement to our discussions with MolDX and with the payers in general.

Speaker 2

The BE-two study, we're continuing to enroll in that study. That's not a linchpin at this point of our market access efforts. We still enrollments picked up a bit and it slowed down a little bit. We've shifted to entirely U. S.

Speaker 2

Studies that U. S. Centers and we've added a few. And that will be just sort of additional complementary. That will be a 3rd case control study on top of the STM and betterment study that will be supplemental, but not that it's not sort of a linchpin of our market access strategy.

Speaker 3

Okay. You know what, we saw on what the BE2, is that case control or is that the screening population? Yes,

Speaker 2

that's case control. Case control. So that's why it will just be sort of a third such case control study and it will be supplementary, but it's not sort of at the heart of what we we think we have sufficient case control CV data and now to screening population CV data to drive our market access efforts.

Speaker 3

Yes, all right. I'll hop off. Thanks so much guys. Appreciate the time.

Speaker 2

All right. Thanks a lot, Kyle. Great questions.

Operator

Your next question comes from the line of Joseph Conway from Needham. Your line is open.

Speaker 1

Joseph, good morning.

Speaker 2

Hey, Joseph. Are you there, Joseph?

Speaker 1

Operator, why don't you put Joseph back in the queue and take the next question.

Speaker 4

My apologies. Can you guys

Speaker 2

hear me?

Speaker 4

How are you doing? Maybe just one on operating expenses. If you guys are planning to keeping volume fairly leveled as well as the sales force before reimbursement comes in, but maybe seeing more traction on these Check Your Future events and what have you. I guess with all of that together, is it safe to say that we should expect a modest increase maybe in operating expenses just on a run rate maybe on the last two quarters? Do you think that's maybe stabilized, I guess, is a better way to answer, ask that?

Speaker 1

Yes. So, the OpEx on a GAAP basis for the last couple of quarters have been in the $12,000,000 or so range. And the triggers for us are clearly on realization of payment. And so with the multiple streams, revenue streams, they will have different influences on where that OpEx goes. To the extent that policy, insurance policy changes positively at a quicker rate, we will start adding additional sales people because that means calling on physicians.

Speaker 1

On the direct contracting side, that typically requires less selling resources. Now we've added to expanded that group from 1 to 2 or in the process of expanding from 1 to 2, because that pipeline is growing rather fast. The sales cycle there is a little bit longer, but once it gets started, the test volume, the ability to increase test volume and therefore payment associated with that is more dependent upon the clinical side of things. And we will add resources directly related to that because that payment is guaranteed. We're not guessing in terms of what we're going to get paid during that period of time.

Speaker 1

So those two streams will influence what happens in sales and marketing. I think on the marketing side, we're still a couple of quarters away from stepping on the gas pedal where advertising will be a component of OpEx. That's probably more of a 20 25 event. So modest increases for the next quarter or 2, the second half of the year, I think that you could start seeing some acceleration in the sales cost line. I think from a research and development or regulatory or clinical research standpoint, I think our level that we're presently at space fairly flat for the next couple of quarters.

Speaker 4

Okay, great. Yes, that's super helpful. Thanks for that color. Maybe and then maybe one on Medicare, the technical assessment process, I guess you guys are expecting that after submission and that starts to take anywhere from 6 to 12 months. I don't know if you have like more narrow timing on that just given your relationship, the meetings that you've already had with Medicare.

Speaker 4

But I guess just maybe some more color on that final approval date or final reimbursement decision that you think?

Speaker 2

Yes. Certainly, we're not in a position to make sort of any kind of hard prediction as to when that happens. I sort of mapped out how what the triggers are for us to request a pre submission meeting. And then based on the results of that meeting, we'll be ready to submit the technical assessment immediately following the pre submission meeting with MolDX and we intend that to be an in person meeting in Houston. So technically the TA processes is to turn around in 60 to 90 days.

Speaker 2

Now like FDA, anybody who's been involved in an FDA process, which says it's 90 days, there's an opportunity to stop that clock, right? They can stop the clock and ask for more information and so forth. So it's a cumulative 60 to 90 days that can stretch on for a period of time. But it's very hard to say once that process starts, just like with an FDA submission, whether you've sort of looked through that 60 to 90 day window or as a result of inquiries along the way and pauses that stretches out beyond that. So really no way for us to predict that at this point.

Speaker 4

Okay, great. Yes, thanks for taking our questions.

Speaker 2

Great. Thanks, John.

Operator

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

Speaker 1

Anthony, good morning. Thank you. Hey, Anthony.

Speaker 5

Hey, Lee, Sean. Hey, Dennis. How are you doing?

Speaker 3

Great.

Speaker 5

So I just want to so I know you switched to a new revenue cycle manager, I believe mid last year and doing a much better job in terms of being able to get reimbursed. I think in the you've submitted approximately the commercial government pays 20,000,000 and the vast majority of those have been adjudicated with half resulting nearly half in the allowed amount of $1800 per test, which seems very positive and much better than what you were doing originally. Does that mean if we and I guess the definition of vast majority, does that mean there's maybe $8,000,000 maybe in revenue that you would expect in the pipeline $8,000,000 plus or how should we look at what's left to be adjudicated?

Speaker 1

Yes.

Speaker 2

So Remember no, go ahead, Dennis. Sorry.

Speaker 1

So your thesis is correct. So when you look at $20,000,000 of submitted claims and the adjudication of 80%, 40% in an allowable amount, you're talking about $8,000,000 or $9,000,000 of possibility. That can be diminished by what the patient share of that will be. It also should be reduced for what we have collected so far, which is nearly $2,000,000 There is a backlog of amounts awaiting for collection that could be as much as $9,000,000 I think looking at that in the range of $5,000,000 to $6,000,000 is probably more of a realistic view, but there's uncertainty about it. So, what gets paid of that, we've got this average that the information we're getting from QuadEx puts the allowable amount right at $18.28 in the last quarter, which is holding.

Speaker 1

I think the prior quarter was just slightly higher than that maybe by $10 or $20 more. So it's in that range, but there's still some uncertainty about that to try and figure out exactly what we're going to collect because of the patient's contribution and the timing related to when we'll get it.

Speaker 2

Can I reemphasize that, Anthony?

Speaker 5

I think the way we look

Speaker 2

at that $1800 is price, right? So we feel like, okay, we're getting allowed claims about half the time and the price that they're sort of acknowledging pricing in the vicinity of Medicare, which is great. Now, if this is a high deductible patient, the patient with a high deductible plan in January, that's the patient responsibility could be all of that. And so that's not necessarily what we're going to the proportion of that average $1800 that gets converted into revenue is really highly uncertain at this point. But what we're gratified by and what we're gratified in terms of the stability of is that pricing, the acknowledgment sort of that, that's an acceptable price.

Speaker 2

That's an allowed price, which we can build our models around. But what we still have time to see, we still have to see where what the how much that allowed amount translates into payment and it's not easy to track, right, because the stuff is a bit out of phase.

Speaker 5

Sure. That's definitely helpful color. And then my last question is around your marketing efforts. I looked at it as a 3 pronged effort between the Check Your Food Tube events that you've discussed, your Lucid test centers and then your satellite offices. As you move as we move through 2024 and go into 2025, how would you look at as best you can forecast the breakout and what's driving more patients?

Speaker 2

Yes, sure. Go ahead. Thanks. Great. No, that's great.

Speaker 2

I'll maybe tweak it a little bit just to focus on what is the patient acquisition strategy in those cases, right? So what you described is really sort of more of a cell collection location, like how where we actually doing the cell collection. And they're very much interrelated. And as you'll sort of note from my comment here that some of this is kind of starting to melt together. But the patient acquisition around our sales force calling on physicians in various settings and getting them to order the test, that still represents 70% or so of our activity.

Speaker 2

And of that, about 70% of that is being performed in the satellite test center model where our practitioners will show up at a physician's office on a regularly scheduled basis and do the testing there. So think about patient acquisition and sort of how is the cell collection stuff being handled. That's so that's that. About a third of our volume right now is in these where the patient acquisition is centered around a Checkatrade food tube event where we are engaged with the Firehouse or now increasingly other types of entities, where we schedule a health fair type event and do the testing accordingly. It's not a result of a direct sales call by our sales folks, right.

Speaker 2

And there the cell collection is in the Check Your Food Tube setting. Now the 3rd area, which I would encourage you to think of as a separate area, but it's now starting to kind of meld with the Check Your Food Tube events is the direct contracting side. So when we engage with, let's say, an employer that through a direct contract, that patient acquisition is done. That's the way we have the contract and there's a certain number of people who are indicated for testing based on guidelines. We base it strictly on guidelines and we proceed to test them a way that's very similar to the Check Your Future events.

Speaker 2

We literally show up at the physical employer locations and test people in a healthcare structure. So the patient acquisition side, it's direct contact and engagement with physicians, a traditional sales process, looking for Check Your Food Tube events through our engagement with fire departments and others and then pathway. Does that make sense? Again, slight difference between patient acquisition and the site and the where the cell collection is actually occurring, there's sort of a matrix of that.

Speaker 4

Actual collection. Yes.

Speaker 5

No, Wishan, that's very helpful color. Just lastly on the contracts with employers or commercial insurers, Is that would you still say that is that in the nascent stage? And is that something I know it takes sometimes a while because they each have their own processes, but is that something that you expect to accelerate as you move through this year and into 2025?

Speaker 2

I think all of the heads to the all is yes. So it's in the early stages. We hired our first person dedicated to this just in November. It seems like it's been longer than that, but in November. And he's filled up the pipeline with regard to engagements with brokers, third party administrators, entities like the 911 Fund and the residential communities.

Speaker 2

That pipeline is filling up very fast. So to the point where we actually are going to hire a second person to help

Speaker 4

them with that.

Speaker 2

But the cycle as Dennis mentioned, the cycles for these are longer than just converting an individual physician account, right? And so and to some degree, they can be a little bit lumpy around open enrollment periods twice a year, particularly those that are related to benefit packages, right, where have to line up a test online with open enrollment. So, very busy, pipeline is filling up, putting more resources into it, but longer lead times. But despite all that, we do really start we really do expect to start seeing some runs across the plate in the coming quarters, both in terms of test volume and revenue and contracts executed.

Speaker 5

Excellent. Thank you so much for the color. Appreciate it. I'll hop back in the queue.

Speaker 2

Thanks, Anthony.

Operator

Your next question comes from the line of Mark Massaro from BTIG. Your line is open. Hi, guys. This is Vivien on for Martin.

Speaker 5

Hi, Vivien.

Speaker 2

How are you doing?

Speaker 6

Good. Thanks for taking the questions. I'll actually maybe just keep it to 1. So just as far as ASP, we've talked about a history of denials and appeals being needed to kind of lay the groundwork for commercial pay. Could you just reiterate some of your comments on the progress that you're seeing there?

Speaker 6

I think you also called out for the first time prior auth being somewhat of a hurdle. So just how you're thinking about some of the puts and takes to ASP? Thanks.

Speaker 2

All right. So let me just jump in a bit on the process side and maybe Dennis has some additional comments. So the prior auth issue is simply one of when you look at denials and the percentage, the breakdown Dennis mentioned about 50% of those are informational or medical necessity. Those are there's an appeals process for that. But some of that 18% are prior auth.

Speaker 2

And remember, this has nothing to do with our it's not directly related to our efforts to impact medical policy. It's through the out of network process. So we figured there are there's enough of a percentage on the denial of 18% that it was worth our while to put a streamlined prior auth process together so that physicians can easily seek the prior auth for what is typically a non urgent test. So that's just simply a way to have access to the 18% of denials that are related to the lack of a prior authorization. That's different than I think what the first part of your question was, which is around the engagement with commercial payers on medical policy, which is something that's now starting to accelerate now that we have what we believe is sufficient CV and CU data to have those conversations.

Speaker 2

We just up until 3, 4 months ago, we didn't really have enough data to be legitimately involved in those conversations. So as I mentioned earlier, we've actually started directly making inquiries and requests for changes in medical policy with some of the brand name margin payers with the hope that if it doesn't lead to immediate change that we can engage in pilot programs and so forth. So I would see that as I would consider that as somewhat different than what we're doing on the prior auth side, which is really a revenue cycle management process. Dennis, did you want to add anything to that?

Speaker 1

Yes. Just Vivien, just go back through the stats in case that's what you were looking at. 54% of those adjudicated were denied. And I gave some color on what half of them, the reasons for half of them and they were $3 right. 7% just needed additional information, 26% were deemed not medically necessary And the question you asked about prior auth authorization was 18%.

Speaker 1

That said, they would like prior authorization before reviewing the claim. So it was a smaller portion of the total, but nonetheless it is showing up as one of the reasons for initial denial.

Speaker 6

Okay, perfect. Understood. Thanks for taking the question.

Speaker 2

Thanks, David. Thanks, David.

Operator

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

Speaker 2

Hi, Ed. Yes. Thank you for taking

Speaker 7

my question. On the high volume check your food tube type events, have you gone to any event more than once? And do you anticipate being some of these events being annual events or what's your time period for going back to these events?

Speaker 2

That's a great question, Ed. And the answer is yes, we definitely have gone back. Like for example, the original San Antonio firefighter event that we did almost exactly a year ago, we went back and retested because the logistics, if you could set up, let's say, 3 or 4 days, you're not going to necessarily get 100% of those who are interested in getting tested and are qualified or recommended for testing based on the risk factors. So we definitely have gone back. We've even had ties where we've gone back and focused on retirees or different shifts and so forth.

Speaker 2

So that's we've done that. What I may just again use this opportunity to emphasize, which is that one of the aspects of this that we're starting to push a lot harder on is as we get started to talk about how we can enter into a contractual arrangement for further testing after the inaugural event to your point. And we do see that as something that could be on a regular periodic basis. Certainly, some of the conversations we're having on the direct contracting side are would be periodic.

Speaker 7

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

Speaker 2

Thanks and take care.

Operator

Thank you. And there are no further questions at this time. I would like to hand it over to Doctor. Rishi Nupalak for closing comments.

Speaker 2

So thank you all for joining us today and for the great questions. I did actually have one additional comment that came from one of our investors that they asked the question of EsoCare because PAVmed released kind of press release recently that indicated that it was reviving some projects, which included eSecure. And I just wanted to confirm and remind folks that eSecure, which is a esophageal ablation technology that fits very nicely within the portfolio of products, it's used to treat the later stage pre cancers that we discover with EsoGuard that Lucid continues to have a fully exclusive license to commercialize that. So although it's being revised at the PABMED level and PAVmed seeking financing to complete its development, including some non dilutive financing, Lucid remains the will be the commercial entity that commercializes it if and when we're able to get that across the finish line. So with that, as always, we look forward to keeping you abreast of our progress via news releases and periodic calls such as this one.

Speaker 2

And the best way to keep up with our news, updates and events is to sign up for email alerts on the Lucid Investor Relations website and to follow us on Twitter, LinkedIn and on our website. So thank you everybody and have a great day.

Operator

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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Earnings Conference Call
Lucid Diagnostics Q4 2023
00:00 / 00:00