Lucid Diagnostics Inc. (NASDAQ:LUCD) Q4 2023 Earnings Call Transcript
Lucid Diagnostics Inc. (NASDAQ:LUCD) Q4 2023 Earnings Call Transcript March 26, 2024
Lucid Diagnostics Inc. isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good morning, and welcome to the Lucid Diagnostics Fourth Quarter and Full Year 2023 Business Update Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Dennis McGrath, Lucid Diagnostics' Chief Financial Officer. Please go ahead.
Dennis McGrath: Thank you, Ludy. Good morning, everyone. Thank you for participating in today's fourth quarter and full year 2023 Lucid Diagnostics business update call. The press release announcing our business update for the company and financial results for the fourth quarter 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. 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 and description of these and other important risk factors and uncertainties that may affect future operations, see Part I, Item 1A entitled Risk Factors in Lucid'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 filings on Form 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'd like to turn the call over to Dr. Lishan Aklog, our Chairman and CEO of Lucid Diagnostics.
Lishan?
Lishan Aklog: 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, as I have a bit of a scratchy throat. I'm feeling under the weather. So sorry about that. And I'd also like to thank our long-term shareholders for your ongoing support and commitment. Hopefully you know our team is singularly focused on driving the Lucid enterprise towards its massive commercial potential and to enhance our long-term shareholder value. So I'm very pleased with the excellent progress that Lucid has made on multiple fronts during the fourth quarter and the start of this year, including strengthening our balance sheet with about $18 million financing from long-standing fundamental shareholders.
We saw solid revenue growth on stable test volume, improving allowances and stable out-of-network pricing. Our CYFT program the health fair events is thriving are now robust clinical validity and clinical utility evidence based are 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 accelerating 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 fourth quarter revenues were just a hair over $1 million. That's up 33% quarterly and 829% annually. EsoGuard test volume was 2,200 tests. I'll talk a bit more about those trends later.
High-volume health fair CYFT testing events continue to gain traction, and we're fully booked right now through July. We have active EsoGuard testing programs now at 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, about 50% of adjudicated claims are now coming back as allowed with stable payments averaging about $1,800. Next slide. Some key strategic accomplishments. As I mentioned, we restrengthened our balance sheet with the $18.1 million preferred stock financing. We've had a significant expansion of our clinical validity or CV at our clinical utility or CU data to support broad EsoGuard medical policy coverage, including reengaging with MolDX for the Medicare side, which I'll talk about a little bit later.
We've seen now three clinical validity studies that document excellent EsoGuard sensitivity and negative predictive value. We have three clinical utility studies that document near perfect concordance with physician decision-making. 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 attended 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.
Just a few intro slides for those of you who are newer to update you on our company overall. Lucid is a commercial stage cancer prevention, medical diagnostics company. We're focused on early pre-cancer 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 widespread screening tool to prevent these deaths through the early detection of esophageal pre-cancer. Next 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 is 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 at Guardant.
Cancer sensitivity remains extremely high as does pre-cancer sensitivity and early pre-cancer sensitivity. And those two numbers, I'll note, are really unprecedented. So to have a 90% pre-cancer sensitivity, again, you can now compare 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 at that 90% range. Again, no other tests, molecular tests can detect early pre-cancer with any sensitivity much lesser than 90% level. That results in an overall negative predictive value of 99%, so just 1% false negative rate and an estimated positive predictive value of 30%, which increases the yield of endoscopies between two and three fold.
Next slide. Just two slides summarizing this data. Again, this is the absolute foundation, the backbone of our future is documenting the performance of the study. 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 three studies, the original Case Western paper, the BETRNet study and Cleveland VA. One is published, two are in preprint. And coming soon, we have a manuscript completed for the BE-1 study, which is now heading towards posting on preprint and submission for publication. Next slide. Similarly, on the clinical utility side, we had now three studies that are published in the peer-review literature and form, again, the foundation of our engagements with payers -- commercial payers, and in the near term with Medicare.
Next slide. The market opportunity here is really fantastic. It's massive. There are absolutely 30 million 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 $1,938. As I noted, our out-of-network payments are matching that quite closely at about $1,800 so that pricing is holding. And that results in an approximately $60 billion true total addressable market opportunity. Our gross margin is 90% at our current volumes. 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. 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 CheckYourFoodTube 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. So this slide shows our the progress over the last approximately per years with regard to revenue and test volume growth. So you can see revenue has been growing nicely since our transition in the late second quarter to our new revenue cycle management provider. So the late second quarter of 2023. The test volume growth has stabilized. And we think this is likely going to be approximately where things stabilize at sort of the 2,300 to 2,500 range. I will note and remind you that we have not added any salespeople since the fourth quarter of 2022 so that growth from about 1,000 tests to 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. In the fourth quarter, we had three weeks that were -- where we weren't able to do testing, between two holidays and one week for our national sales meeting. And so we feel pretty comfortable that these volumes will hold and we'll 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 CheckYourFoodTube, our health fair type pre-cancer detection event remain a significant contributor to our activity. As you can see on the right there, these have been heavily focused on firefighters since we 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. 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 Texas symposium. We're increasing the efficiency of these events and their capacity by utilizing UpScript, our telehealth partner, so we no longer have to identify a local physician champion to get one is off of the ground. We can just jump in and get started with our telehealth partner.
And really, perhaps most importantly, the last bullet here, we're now -- as we launch these events, we're now initiating contracting discussions in parallel with planning for the initial inaugural event. And we found that the leaders are strongly motivated to engage. For example, with the unions, there's very much, on the firefighter side, a 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. 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 EsoGuard 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. 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. 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 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. So there's a whole network of benefit brokers that work with third-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 third-party administrators are both providing to employers to offer EsoGuard 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. And we're active in that. We previously announced we've had our first contract there. Testing is -- has proceeded. And these testing events are very similar to the CheckYourFoodTube 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. We had previously announced that we are engaged with the 9/11 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 to 9/11.
That process, there was navigate the sort of clerical issue back a couple of months ago, but that process is now back in full swing. We've formally engaged with one 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 Sun Belt, 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. The way -- what we offer with this direct contracting are really three 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 model is particularly when it's in the context of a benefit plan and offer EsoGuard as a covered benefit. It's a charge for a lifetime benefit per member, not necessarily those who are tested. And then we also are in discussions in several examples of just a service agreement where we charge for a full or half-day screening event that's up to a certain -- that can handle up to a certain number of patients in a given day, and those are scheduled accordingly. So that's our direct contracting initiative, a big deal. We're pushing hard on this, and we really do expect this to be a meaningful contributor to test volume as well as the revenue in the coming quarters.
Next slide. Just an update on the entire process by which we submit claims, receive payments on those claims and generally pursue in-network coverage on the revenue cycle management side. Again, this represents a payment for out-of-network claims, and we've submitted now since we made our transition to Quadax, our new revenue cycle management provider in June, about $20 million of pro forma revenue in the claims submitted represent that. 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 those -- the claim is allowed and the average allowed payment is $1,800, and we can actually go and collect that either from the payers or ultimately from the patients.
We're also working very hard with Quadax on the appeals process. We're starting to yield some wins. We're winning about 25% of our appeals. And there's an entire process 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. 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 in-network coverage both from commercial payers and Medicare. 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, 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 it initiates a discussion. Either if we're 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 adviser and Head of our Medical Advisory Board, Dr. 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 plan. And so that was a very positive engagement. On the Medicare side, we are targeting reengagement with the MolDX program, which is the entity that finalizes local coverage determination. 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 test that's in effect.
And we now believe we've collected sufficient clinical validity and clinical utility data to make that reengagement. The timing of that, of our meeting and pre-submission meeting with them is triggered on the publication of one of the key clinical validity studies, the BETRNet study and that we expect to happen any day now, at which point we will ask for a meeting. Then based on that meeting, proceed to a technical assessment submission. So based on what's now a 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's a mandatory commercial coverage for certain biomarker tests, and that gives us the opportunity.
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 two 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. Again, it guarantees mandatory commercial coverage where this legislation occurs. And by achieving this, we're able to actually work on targeting our resources, whether they be our 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.
Dennis McGrath: Thanks, Lishan. The summary financial results for the fourth quarter 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-K, which was filed with the SEC last night that is available on our website. So on Slide 18 here, you see the balance sheet cash at year-end was $18.9 million. We supplemented that balance with the financing that we completed just two weeks ago in the amount of $18.1 million. The average quarterly burn rate for last year was $8.2 million per quarter, as you can see in the statement of cash flows in our 10-K.
Burn in the fourth quarter was $6.7 million from operations and $3.4 million from paydown of intercompany debt. We disclosed in the 10-K that our ability to fund operations beyond one year from today is largely dependent upon how revenues ramp over the next five 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's nothing substantively remarkable about the remainder of the September 31 balance sheet. However, subsequent to year-end, in addition to the incremental $18 million of cash infusion, Lucid settled approximately $4.7 million in debt to PAVmed by the issuance of approximately 3.3 million shares of common stock.
Shares outstanding, including unvested restricted stock awards, as of today is 48.2 million shares, which includes 242,000 shares issued subsequent to year-end in connection with converted notices received from the convertible debt holder. The GAAP shares outstanding of 42.3 million are reflected on the slide as well as on the face of the balance sheet in the 10-K. GAAP shares do not reflect unvested restricted stock awards. With regard to the P&L on Slide 19. It compares this year's fourth quarter to last year's fourth quarter and similarly for the yearly totals on certain key items. Trust you'll review the information in my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information.
Revenue of $1.04 million for the quarter, a 33% sequential increase over the third quarter and is in line with what was previously previewed. The amount reflects actual cash collections for the quarter plus a small amount of invoiced EsoGuard test delivered to the Veterans Administration, plus about $26,000 in initial billings under the direct contract with the Ancira Auto Group. The revenue increase reflects about a ninefold increase over the prior year quarter and about a sixfold annual increase over the prior year. Test volume at 2,200 tests for the quarter represented just over $5 million in submitted claims for the fourth quarter at our $24.99 standard pricing for the test. For the first quarter of 2024, revenue is tracking to be on par with the fourth quarter.
Revenue recognition is a key determinant of the probability of collections. 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-K, 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. Our non-GAAP loss for the quarter of $9.9 million reflects about $600,000 in sequential increase compared to the third quarter and about $700,000 decrease year-over-year. The increase in the fourth quarter was related to three specific onetime events and 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&A patent expenses of about $250,000. 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 period is reflected. Total non-GAAP OpEx was $10.9 million for the fourth quarter 2023 and this is fairly flat year-over-year, an increase from the third quarter, reflects the clinical research, the onetime PAT 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. The variable cost for each test is approximately $200 or effectively at 10% to 11% 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 four quarters, plus or minus $0.01 between each of the four quarters of 2023. On a GAAP EPS basis, noncash charges accounted for approximately $0.03 per share in the fourth quarter. A little bit more about reimbursement details. So since the new revenue cycle manager, Quadax, took over in mid-June, Lishan has given you some details, there were 7,800 claims representing approximately $20 million in pro forma revenue have been submitted for reimbursement either to government or to traditional health insurers.
About 82% 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 $1,828 per test. Now out of that amount still has to be reviewed with the patient, what's their out-of-pocket, what's their deductible, which could lower that effective amount. But the insurance companies are holding to the general pricing line and all out of network $1,828, that should be viewed very positively in terms of the benchmark Medicare $1,938. Of those denied, about 51% require 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 those denials.
About 29% were deemed to be noncovered. So with that, operator, let's open it up for questions.
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