Lucid Diagnostics Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 14, 2023

There are 8 speakers on the call.

Operator

Good morning, and welcome to the Lucid Diagnostics Third Quarter 2023 Business Update Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Michael Parks, VP, Investor Relations.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Good morning, everyone. Thank you for participating in today's Q3 2023 business update call. The press release announcing our business update for the company and financial results for the 3 9 months ended September 30, 2023 is available on the Lucid website. Please take a moment to read the disclaimer about forward looking statements in this press release.

Speaker 1

The business update, press release and this conference call include forward looking statements, These forward looking statements are subject to known and unknown risks and uncertainties that may cause the 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 For a list and description of these and other important risk factors and uncertainties that may affect future operations, see Part 1, Item 1A Quarterly reports on Form 10 Q and any subsequent Form 8 ks filing. 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.

Speaker 1

I would now like to turn the call over to Doctor. Lishan Aklog, Chairman and CEO of Lebluzoo Diagnostics. Doctor. Aklog?

Speaker 2

Thanks, Mike, and thanks everyone for joining us this morning. I look forward to offering an update on Lucid's business as well as its finances. I don't think it's hyperbole to say that this Q3 has been the most important quarter in the company's history. We crossed several critical milestones in translating test volume growth into revenue and revenue growth. We've had 8 consecutive quarters of steady growth in test volume.

Speaker 2

We performed 2,575 commercial EsoGuard tests, which is 17% quarterly growth and 137% annual growth. Even more importantly, we recognized revenue of 783,000 dollars, which is a nearly 400% increase quarter on quarter and nearly a 1000% increase annually. We had strong contributions from our Lucid test centers, the satellite Lucid test centers and our high volume check your food tube testing events, which are gaining traction as well as Attraction with our strategic accounts, which I'll discuss further, these include health systems and academic centers. Our strategic accomplishments include The following: we upgraded our revenue cycle management infrastructure and processes as we discussed in our last call And we've been delivering solid results with EsoGuard claims processing and payments. We had a very strong boost to our clinical utility data to support in network payer coverage engagement and we've reported near perfect results in over 1500 patients across 3 studies that have been released: The CLUE study, the PREVENT registries and our San Antonio Fire Department study.

Speaker 2

2 of these have been accepted for peer review publication and one is pending. We're accelerating activities in direct contracting with employers to offer EsoGuard as a benefit. Our first contract was signed and testing has begun this quarter. We hired a VP of Employer Markets that's pushing this initiative forward. As we announced recently, we also launched the 2.0 version of our EsoGuard assay, which has demonstrated significant improved performance and lower costs.

Speaker 2

First, a couple of background slides here. A bit about our EsoGuard esophageal DNA test. EsoGuard is the 1st and only commercially available test that's capable of serving as a widespread tool to prevent esophageal cancer death The 16,000 annual esophageal cancer deaths are preventable. Early pre cancer detection, however, is necessary to prevent cancer. We often talk about cancer prevention rather loosely, but it's important to emphasize That our target, our goal here is to prevent cancer while most initiatives, most screening tests are just detecting cancer early, which insufficient in this particular cancer.

Speaker 2

Less than 5% of those who are recommended for screening undergo endoscopy and we now have an opportunity with this The test is recommended in major professional society clinical practice guidelines. Just a quick overview of EsoGuard's performance. We've used the term that the performance is really unprecedented with regard to cancer and pre cancer detection. You can see here in the blue the EsoGuard results for cancer, pre cancer and early stage pre cancer, very competitive to other Comparable early detection test, whether it be Cologuard's colorectal stool test, Guardant Shield's colorectal blood test. But the key differentiating factor here that makes this unprecedented is its performance in the critical As I mentioned, it's necessary to have an impact on this disease.

Speaker 2

You can see that our overall pre cancer detection rate is Nearly 90%, which is again unprecedented and substantially better than other early detection tests. And if you move earlier So the early pre cancer stages, we continue to maintain excellent detection of those levels and the other screening tests really have no ability The EsoGuard commercial opportunity is quite large. There are at least 30,000,000 patients who by existing professional society guidelines are at risk chronic heartburn patients who are recommended for Medicare has established a payment rate of $19.38 and that rate has held up in pricing and payments from commercial payers. That leads to a very large multi $1,000,000,000 total addressable market and our gross margin of the test is over 90% at Even at current volumes right now. So we're really proud to report that we continue to show Growth in EsoGuard testing volume.

Speaker 2

This is our 8th consecutive quarter of meaningful quarter on quarter growth in 2 consecutive years. We performed 2,575 tests in the 3rd quarter, which is a 17% increase from the prior quarter and 137% increase from the prior year. This is still well below our near term laboratory manufacturing capacity, which is over 10,000 tests per quarter. I should note that this result has been with our sales team headcount remaining flat. We've used the term mid throttle approach, which is exactly what we're doing here.

Speaker 2

We're trying to drive test volume to support claims history and clinical utility. As this is at these volume levels, we have sufficient volume to do that. We won't push to a full throttle until we get continued progress on payment. And we plan at least for the coming quarters to keep our sales reps the sale headcount flat, which may at some point in the coming quarters reach the limits of our per rep Productivity, but we'll watch those numbers over the coming quarters. This slide shows continuing trends with regard to the referral sources We continue to have about a 2:one ratio between referrals from primary care physicians and referrals from specialists or institutions.

Speaker 2

One trend that continues to increase is that the percentage of cell collection procedures that are performed by Lucid personnel, Either in physical Lucid test centers or on the satellite Lucid test centers continue to rise and now represent over 80% of the total volume. So a few comments on several aspects of our commercial execution. Our field team, as I mentioned, has been able Drive steady volume growth despite a flat sales headcount and continuing improvements in productivity. As I mentioned, our satellite Lucid test centers where our Clinicians go to physician practices on a regular cadence and perform EsoCheck cell collections. This satellite Lucid test center model remains a top driver of our test volume and has really expanded our geographic reach and our ability to be front and center with physician practices.

Speaker 2

Our Check Your Food Tube pre cancer detection events, Which we started earlier this year, continue to grow. We've had dozens of events. We are expanding beyond firefighters. We've had our first event with policemen. And we're also engaged earlier with the group leadership, whether it be a union or other entity regarding contracting as opposed to just simply submitting the claims for those events.

Speaker 2

Another important update is that we're transitioning to use our As I mentioned, we are making a major push into direct contracting. It's been an area of focus for us for a couple of quarters. We've had our 1st contracted employer, Ensira, which we've announced. And the testing at multiple sites for Employer has begun and will continue through this quarter. And we're very excited that we've hired a new VP of Employer Markets with 30 Plus years of experience in employer benefit sales and he starts this week and we're really looking forward to a Significant productivity for him.

Speaker 2

As I've mentioned on prior calls, we've been pushing harder on strategic accounts. These have longer lead times, but have the opportunity for significant yield. And we are gaining traction with health systems and with academic medical centers. We have Active testing now at the AdventHealth Center in Florida, the Northwestern Medicine in Chicago and even at Mayo Scottsdale. We've been pushing quite hard as we've talked about on prior calls on MarketAxess.

Speaker 2

So MarketAxess, just to remind folks, it really has 2 pillars. 1 is revenue cycle management, which is the process of claim submission, adjudications, Peer to peer appeals and prior authorization, we'll talk about that in some detail. And also the payer relations side, which is Getting positive medical policy and coverage, our legislative advocacy work, working with managed care plans in the Veterans Administration, as well as lab benefit management. And we are pushing hard with persistence and creativity. We have a new VP of market access who is working hard On payer pilots, we're quite active in the biomarker states, which I'll touch on in a bit, and other initiatives to drive payers So a few more details on this.

Speaker 2

On the revenue cycle management side, we announced last quarter that we had transitioned to and upgraded our revenue cycle manager to QuadEx and we have seen some initial very promising results with regard to claims processing and payments. I'm happy to report that that initial spike and initial positive news has held up that the allowed claims percentages, which is the percentage of claims submitted that where the payer Allows payment, that has remained really solid and steady as has the average allowed payment which approaches our Medicare payment So we're really excited about that and that's been driving the revenue and where we expect to be revenue growth moving forward. We also have had meaningful activity on the appeal side. We have a robust and active pipeline of claims that are going through appeals And we are seeing successful appeals based on medical necessity versus guidelines, something that once we get in front of medical directors through the appeals process, We are able to have very strong conversations, particularly when the appeal is based on medical necessity by explaining the support of existing clinical practice guidelines for our test. As I mentioned on the payer relations side, we're pushing quite hard.

Speaker 2

As I mentioned also our UVP of Market Access is now actively engaged with multiple commercial payers and we're pursuing multiple pathways to These include active discussions with pilot programs such as CED programs, which are coverage with evidence development programs that we look to Secure in the coming quarter or 2. And I can't overstate how important the burst of positive clinical utility data That we've seen over the past quarter, how important that is in support of our payer engagement. As I finally, as I hinted at, There is biomarker legislation that's now in over a dozen states, which mandate coverage of certain biomarker tests in those states and it offers us a very promising path to coverage and it's something that we're actively engaged with. Here are a few more details on our clinical utility studies that we've announced. We have 4 studies, One of them retrospect, 3 of them prospective that we've previously reported on, the San Antonio Firefighter Study has been accepted for publication with 385 patients.

Speaker 2

The CLUE study, which is our prospective multicenter observational study, We had interim data on just under 300 patients that was submitted for peer review and is currently undergoing review. Since that data was released, we've Increase the total number enrolled and in whom data has been collected to 535, which gets us within a hair's whisker of being able to complete enrollment And close out that study and submit the full data set for peer review. The heart registries, which we've The PREVENT registry and the subset of that, which is the PREVENT firefighters registry, is a prospective multi center observational registry that we run And we've announced interim data that's been accepted for publication and we'll continue recruiting Really for the foreseeable future as this data is useful not only for clinical utility, but also clinical validity, and also to enhance The research and development efforts in our laboratory, we've had 641 patients to date. So a total of over 1500 patients, which is a substantial amount of clinical utility data that will serve us well in our near term engagements and discussions with commercial payers. Finally, the ASVE study, which is a prospective virtual patient randomized control study is still recruiting.

Speaker 2

We're at just under 80 patients and looking for Couple dozen more patients before we close that out and do the final analysis. I'll point out and remind you that As we've noted in our press releases, the data from the 3 studies where we've released data has been outstanding with really near perfect results and Your perfect concordance, what that means, and this is the critical thing from a payer's perspective is that 100% of positive patients are being referred for confirmatory endoscopy And that nearly 100% of patients who are EsoGuard negative are not being referred for endoscopy with the occasional 1 or 2 patients who are referred for indications other than screening for precancer. So those are outstanding results, which demonstrate The ability of EsoGuard to serve as a triage test and have a substantial impact on medical decision making, which is really the definition Clinical Utility in this setting. Finally, as we reported earlier, this week we launched our EsoGuard 2.0 Version of the assay, which we're very excited about, this improves on the already unprecedented cancer and pre cancer detection results that we've already shown that are based on our EsoGuard 1.0, this breakthrough was a result of implementation of a technique called multiplexing, which allows all of the genes, the 2 genes to be assessed in one sample and it allows us to run the assay three times and do a consensus call of positive and negative results, Which can significantly improve the performance of the assay near its cutoffs.

Speaker 2

That the analytical validation studies or AV studies that were used to get this to launch. That data is being presented at this week's Association of Electric Pathology Annual Meeting or AMP 2023 in Salt Lake City. As we also reported, we are upgrading our NGS sequencing platform to a higher throughput Illumina NextSeq 1000 To accomplish to accommodate, excuse me, the increased E Cigar testing volume that we've demonstrated, both of these updates, the 2.0 version of the assay as well as moving to the NextSeq will allow us to have significantly lower per sample sequencing. Also as we announced, we're having we're very excited. We're holding an Investor Day in New York City on December 13 from 10 am to To begin, we and other key opinion leaders and other experts will be providing growing an in-depth Educational event on all things Lucid and all things Visa card and further details of this will be provided on our investor website when they are available.

Speaker 2

With that, I'd like to pass the baton off to Dennis, who will provide us with our financial update.

Speaker 3

Thanks, Lishan, Good morning, everyone. The summary financial results for the Q3 reported in our press release that was published last night. On the next three slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context The full disclosures covered in our quarterly report on Form 10Q, which was filed with the SEC last night and is available on our website. With regard to cash at $24,100,000 this does not include the $5,000,000 additional funding shortly after the end of the quarter. As the funding occurred 2 weeks earlier, pro form a cash would have been 29,100,000 The sequential change in the cash balance reflects a 3rd quarter burn rate of $8,500,000 including a reimbursement to PAVmed of approximately 2,200,000 Absent this payment, the burn rate would have been $6,300,000 which is slightly less than the average burn rate for the 1st 3 quarters of $6,600,000 Given the pro form a cash of just over $29,000,000 and a steady state for the burn rate below $7,000,000 The simple math suggests that if this rate is sustained, it puts our runway to more than a year.

Speaker 3

The burn rate Most of the year has been softened by PAVmed deferring most of its quarterly management service payments since October of last year. This PAVmed optionality for paying the outstanding intercompany obligation in stock or cash at PAVmed's election serves to increase PAVmed's ownership while strengthening Lucid's balance sheet. This flexibility payment in stock or cash has created some breathing room for Lucid to allow cash collections to catch up to the submitted reimbursement claims, which we will talk about in a second. With regard to AP accounts payable, since the beginning of the year, if you examine the trend for the key current asset accounts, Mainly prepaid expenses and vendor deposits and you compare that sum against the quarterly changes in the sum of vendor payables and accrued expenses, There is no substantive volatility, just mostly timing differences. Hence, the burn rate is not substantially influenced by changes in the net working capital balances.

Speaker 3

With regard to the intercompany debt to PAVmed, it's flat sequentially and the reflected balance is largely pegged To be settled in stock issued to PAVmed. Shares outstanding including unvested restricted stock awards as of today is 44,700,000 shares, which includes 276,000 shares Purchased by employees during the quarter as part of their participation in the company's employee stock purchase plan as well as 115,000 shares issued during the quarter in connection with conversion notices received from the convertible debt holder. The GAAP outstanding shares of 42,300,000 are reflected on the slide as well as on the face of the balance sheet in the 10 Q. With regard to Slide 17. Slide 17 compares this year's Q3 to last year's Q3 and similarly for the 9 month totals on key Certain key items, I trust you'll review the information in my comments in light of the cautionary disclosure at bottom of the slide about Supplemental information, particularly non GAAP information.

Speaker 3

Revenue of $783,000 for the Q3 reflects actual cash Collections for the quarter, plus a small amount of invoice EsoGuard tests delivered to the Veterans Administration. As you can see, that is about a 10x increase over the prior year quarter and about a fivefold increase over the Q2 of this year. Test volume at just under 2,600 tests for the quarter represents just about $5,000,000 in submitted claims for the 3rd quarter. You will recall from our discussion in the last quarterly call that we made a major change and upgrade to our revenue cycle management company. So far, for the 1st 6 weeks of the Q4, weekly collections have been averaging about 33% higher than the 3rd quarter with a weekly high so far of $95,000 in a particular week.

Speaker 3

With regard to revenue recognition, A key determinant is the probability of collection. And therefore, due to the fact that we are in the early stages of the reimbursement process Means revenue recognition occurs when the claim is actually collected, first when the patient report is 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. Our non GAAP loss for the Q2 of $9,300,000 reflects a 3.1% sequential decrease Compared to the 2nd quarter loss and approximately a 9.4% decrease year over year as a result of the cost control initiatives we put in place at the beginning of the year. Slide 18.

Speaker 3

Slide 18 is a graphic illustration of our operating expenses for the periods reflected. Total non GAAP operating expense is $10,000,000 for the Q3 2023 and is a fairly flat sequentially is fairly flat sequentially and year over year. Except for G and A that included some increased IP filing fees, all operating expense categories were in line or lower. Cost of revenue primarily consists of EsoCheck devices, lab supplies and fixed lab facility costs. The modest Increase in cost of revenue of about $85,000 is directly tied to the sequential increase in test volume.

Speaker 3

Sequential test volume increases of about 3.75 tests and about $200 of variable cost controls, cost Accounts for the slight increase between the 2nd and third quarters, effectively an 11% marginal cost of sales for the increased test volume Quarter versus quarter. The non GAAP loss is slightly better sequentially by a $0.01 per share and $0.06 per share year over year. On a GAAP EPS basis, non cash charges accounted for approximately $0.12 per share in the quarter, including approximately $0.07 per share related to the change in fair value of the convertible debt. If you normalize the loss By adding back the effect of the change in fair value of the convertible debt, the GAAP EPS improved by $0.07 year over year for the quarter Approximately $0.26 year over year for the year to date comparison. Some reimbursement details.

Speaker 3

Since the new revenue cycle manager was put in place, QuadEx took over in mid June. 5,000 claims Representing approximately $10,000,000 in pro form a revenue have been submitted for reimbursement. About 70% Have been adjudicated and 30% are pending. Out of the 70% that have been adjudicated, Approximately 39% have resulted in allowable amount by the insurance company with a mean average of $18.63 per test, essentially right at the Medicare rate. Of those denied, About 58% require either additional information or deemed not medically necessary will require a prior authorization.

Speaker 3

About 36% were deemed to be noncovered. With that operator, let's turn it

Operator

Our first question comes from Kyle Mixon with Canaccord. Please go ahead.

Speaker 2

Good morning, Kyle. Hey, Kyle.

Speaker 4

Hey, Lishan. Hey, Dennis. Hope you guys are doing well. Good morning. First question on the RCM Situation, you said that weekly collections were, I think, turning like 30% higher.

Speaker 4

Just wondering how that kind of flows into the P and L. You did $700,000 in revenue this quarter, or I guess last quarter in 3Q. Could you approach based on that math with the 30% higher collections and everything, could you approach or exceed $1,000,000 maybe in the Q4 based on the higher collections or just kind of thinking about the run rate or the kind of reflection point in volume and revenue going forward?

Speaker 3

Yes. First off, the collections are directly related to the future revenue That will be recognized. The only small piece, we do have this study with the VA to the extent We have additional tests with them and that last clinical study is near its conclusion, although there'll be another upcoming one. And that is recognized on invoice basis only a handful of revenue last quarter. And to my comments, collections are increasing, increasing at a Increasing rates, the average so far for the quarter puts us over $1,000,000 in recognized revenue For the Q4.

Speaker 3

So your assumption is correct.

Speaker 4

Okay. Thanks for that, Dennis. And then the actually, you know what, just on this note about the financials, Just looking at the slide with the EBITDA and net income and everything, it's pretty similar year to year and even the 9 month data is pretty, I mean, It hasn't really contracted much, I guess, like you're still kind of probably burning a similar amount of cash. What's your guys' thoughts on getting Cash burn down over time or is that a priority for you as you think about the path of profitability as EsoGuard kind of like gets out there In the field more broadly and like I just said like in flux and everything out there in terms of adoption, is that a price like what levers can you pull? I think you mentioned something about like reps Stabilizing everything and maybe possibly increasing over the long term, but how are you thinking about all these things like kind of converging into like expenses and cash burn?

Speaker 2

Let me get some high level comments and then Dennis will I think some of your assessment of the numbers you might tweak a bit. So Look, this is the balancing act. We've said it before, we'll say it again that what we're balancing here is driving test volume growth to now a level that is sufficient for us To really have sufficient claims history to engage with medical directors and payers and so on and so forth, while trying to keep our burn rate down in this particular environment and that involves keeping our sales headcount flat for this entire year. So that's we've been really happy honestly with how That's worked and that the test volume growth has been steady. We've been able to do that with a flat headcount, while making the progress that we need on the revenue cycle management side, claims processing, claims payment and so So I do think, Dennis, maybe you can sort of dive a little bit more into the impact of the reduction in force and The restructuring early this year with regard to our burn rate over the past year as well as moving into the future.

Speaker 3

Yes. So Kyle, if you look at that EBITDA number of 9,251 On the Slide 17, the inclusive of that is about $22.50 in intercompany obligations from Lucid to PAVmed. And as I indicated in my comments, ideally, the PAVmed would accept that in stock. And therefore, and which has been the case, where the majority of time since last October. You back that out, that gets you right to around the burn rate that I commented on that's sub-seven million And we believe the levels of OpEx that we're seeing right now, we can maintain until we see the acceleration of Collections to a higher degree, which will then definitely accelerate in our go to market strategy and we know exactly where those initiatives would gear up.

Speaker 3

And so if you look at how that burn rate can change over the next 4 quarters, let's say, over 2024. Collections is a key part of that. Even if the Submitted claims of $5,000,000 a quarter stay relatively flat. The demand side of this equation is Still pretty strong. Then as you increase the amount of collections, you did calculations based upon the information I gave you for the first And you're over $1,000,000 As that continues to increase as a percentage of that 5 minute submitted claims, the burn rate will go And we're expecting based upon the initiatives from our market access team and now having published data On clinical utility, that trend certainly should be realized.

Speaker 3

So we think that we've hit the right tone with the level of OpEx. Obviously, if those assumptions on the revenue collections are not hit and we see that as only a Remote possibility, but if true, then we would seek to reduce our OpEx even further. But as Lishan indicated, we're trying to strike that balance. Claims history is important to get reimbursement. And it's just important because you need to have the attention of the Chief Medical Officers for them to deal with what our market access team are presenting to them.

Speaker 3

So We think that the OpEx will remain flat, our collections will increase, the burn rate will go down because of all those the sum of those factors. Okay.

Speaker 4

Thanks, Dennis and thanks, Lishan, for the earlier comments. Lishan, on the EsoGuard 2.0 assay, Couple of questions about that. I guess first like why is now the right time for the assay launch? I mean, I feel like 1.0 has been in the market for a couple of years. It's not fully penetrated just yet.

Speaker 4

It's still kind of like on that upward trajectory. How are you thinking about FDA approval for the new assay? How much data has generated and like how much will be generated going forward in publications and that sort of thing? And then how much lower in cost of goods sold With this lower with this 2.0 assay have compared to the former, and also the turnaround time, I feel like that's something that might improve or actually may

Speaker 2

So some

Speaker 4

of those factors that you could just touch on those would be great to know.

Speaker 2

Yes. So look, it's the same assay, Kyle. It's the same genes, it's the same CPG Island, the same methylation side. So there's nothing fundamental at the core with regard to how we're interrogating the biologic process that's going on here. So this is really incremental improvement that has that does have a meaningful Incorporation of really cutting edge technology with regard to doing this in a multiplexed fashion.

Speaker 2

So that's just to be clear, we're not introducing an entirely new assay. We're just taking the same underlying biology, the same genes, the same methylation and Performing the assay in a more efficient way that will give us perhaps a bit of additional edge on performance, particularly as we move Screening population towards where the magnitude of the positives can be closer to the cutoff. So we're just Yes, kind of picking our way and doing continuous improvement and that's honestly what we should all be doing. The in terms of the regulatory question Right now, as you know, this is being marketed as a laboratory developed test and we have had engagement over the years with FDA through Multiple pre submission meetings as well as a breakthrough device and we will be reengaging with FDA over the long term to I have Isagard presented as an IVD. But we have this is the point is exactly what you suggest, We obviously want to have the best version of the assay as we enter into studies that would ultimately over the long term get us IBD, which we'll do and will be necessary for us to do under the current proposed FDA rule.

Speaker 2

So yes, we're just Making it better and it's getting incrementally better and we think it will be that will be beneficial and useful for the Existing commercial volume and then subsequently as we advance to future studies, We look to take advantage of these benefits and we may look to continue to improve it. The overall cost, the primary impact on the cost is On the sequencing cost, which is a meaningful portion of that, I won't Dennis, Pappy, if you'd like to chime in on sort of what the magnitude of that is in terms The COGS, I mean, obviously, we're still we're operating with a substantial gross margin to begin with, but we do think it will have a meaningful reduction in cost. So I'll pass that on to Dennis, but before I do on the let me just comment briefly on turnaround times. Right now our turnaround times are 7 to 9 days. There is certain fundamental core components of that, which include the time it takes to transport the sample to our central laboratory and certain sort of steps along the way with DNA extraction and the bisulfide conversion and so forth.

Speaker 2

To be perfectly honest, 7 to 9 days is perfectly fine. This is an elective test. The decision making around how to what to do with the results of the test is to schedule an endoscopy. And so we're quite happy at that level. There may be at higher volumes an We're continuing to shave a day or 2 off of that, but that's not going that would not be meaningful from a clinical point of view.

Speaker 2

So Dennis, I don't know if you have any further thoughts On the cost of the improvements in cost with the 2.0 version?

Speaker 3

Yes. Look, we need to prove it out, but It's safe to assume that we think there's about a 10% improvement in our actual cost there.

Speaker 4

Okay. All right. That was like great color. Thanks for all that guys. Sounds like it sounds like a similar, I'd say like you said, Lee Sean, like a fundamentally similar Performance has gotten better and improved.

Speaker 4

The workflow is now more efficient. So the COGS improved as well, 10% is pretty good, I would say. So that was great. Let me just ask a really Before I hop off, this progress with commercial and private payers, what are they reimbursing on average? Remember in the past that was like 50% to 60% of the Medicare rate, like how is that looking now?

Speaker 2

Yes, Dennis.

Speaker 3

Kyle, maybe you can restate your question in terms of I'm not sure exactly what's because we talked about allowable claims at nearly the $1900 right? What were you trying to dissect further?

Speaker 4

I guess the commercial payer segment in the past on average, I believe that was That bucket was kind of paying roughly half at 1938 rate. So like I think it was like 1100 or 1200 around there, but maybe that has changed in past quarters. So Is there any

Speaker 2

I think it's fair to say it's gone up, right, Dennis?

Speaker 3

Yes. Yes. It has gone up and I'm actually reaching for the number. So I don't think we published that exactly. So the mean average of Allowable claims is $18.63 The actual payment rate?

Speaker 2

That's what you're looking for that. The actual payment rate is dependent on a few other variables in terms of like deductibles and the portion that the patient is Responsible for that varies year to year based on enrollment periods and so forth. But I think as a generic statement, the Average payment that we're getting for commercial payers is actually higher than it was when we were saying that we were getting about 50% to 60% of our bill rate, so the $2,500 bill rate. So it's definitely increased, if that's your question, Kyle.

Speaker 4

That was perfect. Again, thanks so much guys for all the commentary.

Speaker 2

Just wanted to emphasize one I just want to reiterate one other thing. So the test is not similar. It's the same The same test just better in terms of efficiencies and so just to be clear, the underlying biology is identical to the original just wanted to make sure that there was no confusion about that.

Speaker 4

Yes, the 2.0. Okay, got it, got it, Wishan. All right. Again, thanks a lot guys. Appreciate it.

Speaker 2

Thanks, Pat.

Operator

Our next question comes from Ross Osborne with Cantor Fitzgerald. Please go ahead.

Speaker 5

Hey, Ross. Good morning. Hey, guys. Congrats on Dargrath. Thanks for taking your questions.

Speaker 5

Good morning. So you mentioned targeting police officers for new pre cancer detection events. Would you discuss the rationale for this And if you plan to create a registry from these events similar to firefighters?

Speaker 2

Yes. No, I think the expansion beyond firefighters And to other groups is really I would think of it more generically as opposed to policemen being Having sort of unique risk factors associated with it. It really is a population. If you look at the Risk factors for having esophageal precancer, yes, there's a reasonably high incidence amongst them, but not because of any particular occupational exposure as opposed to in firefighters where it's Really very well documented that they have increased cancer rates in general and the 2nd highest increase in that cancer rate and those cancer rates is amongst So, it's good opportunity for me to emphasize that we remain very focused on firefighters as a specific Population, that's why we've split our registry to include a dedicated subset of firefighters. I would view the policemen as basically just a broader expansion of our finding sort of a captive audience, a group that has A reasonable rate of having the risk factors and being good candidates for testing and having them aggregated in the entity Such as police unions that will give us an opportunity to target a larger group at once and to improve access.

Speaker 2

And so we'll continue to expand these CYFT events into other groups. There's public service employees and it really starts to kind of meld into The broader direct contracting initiative that we're just getting off the ground with our first employer. So if you think of employers as self insured entities, unions, They really are sort of part of the same spectrum of just collective groups of patients where we have potential for high yield events such as our CYFT events. The Firefighters are special in that they have a clear elevated risk and require and Justify on targeted focus. Does that make sense?

Speaker 5

Yes, makes perfect sense. And going off of that and apologies that this is addressed in prepared March, Couple of calls, but would you discuss how your conversations going with additional employers for direct contracting? Do you think it should be a key driver for 2024?

Speaker 2

I think it should. The conversations we've had and the conversations we had with our first employer Contracts, the ones that are undergoing testing right now this quarter as we speak, it's really interesting. There's a sort of a sweet spot of kind of small to medium employers Who are self employed where one esophageal cancer patient amongst them or one cancer, other kind of cancer Can have a really big impact both economically, if they're self insured, and then they have some reinsurance and there are other opportunities to cover that. But right now, the esophageal cancer diagnosis will typically cost about $1,000,000 or more once you get through all the surgery and chemo and radiation and immunotherapy. And so there's a strong economic argument to be made for these, particularly for the smaller to medium companies.

Speaker 2

There's also a human element there where these tend to be close knit Organizations and the impact of cancer or cancer death within that organization is really meaningful on a private human level. And so our ability to have these conversations and to and there's a real motivation on leadership at Employers to provide their patients with something that they would deem to be a real benefit to them. The whole area of offering testing as part of a broader health and wellness Benefit programs sort of separate from your medical insurance, coverage under your medical insurance through standard claims process is really a blue ocean. It's something that other companies, other diagnostic companies have had good success with. And there's a whole sort of untapped ecosystem out there that we are about to Really dive head first into with Jim Fraccioni, our new VP of Employer Markets, of Working within the ecosystem of brokers and others that work with employers to get their health and wellness benefit programs You think of that more along things like smoking cessation and nutrition and other things, add on things that are benefits that employers can offer their employees.

Speaker 2

But targeted testing, particularly testing that's designed to prevent cancer falls within the same rubric there. So Super excited. These do there are there is a cyclical nature of this. They tend to peak around open enrollment periods, but there is a lot of opportunity And an opportunity that supplements and in some way short circuit some of the even more traditional routes going through payers. Yes.

Speaker 2

Super excited about us diving forward into this.

Speaker 5

All right. Sounds great. Thank you guys. Congrats on the progress.

Speaker 2

Thanks, Ross.

Operator

Our next question comes from Mike Matson with Needham and Co. Please go

Speaker 3

ahead. Good morning, Mike. Yes. Thanks.

Speaker 5

Good morning. Thanks for taking my questions. I guess I wanted to ask about Dennis, just given the trends you're seeing with the revenue cycle management, collections and so forth, do you have any feel for And our ability to predict when you could maybe start to recognize revenue when the tests are actually performed as opposed to when you get paid for them?

Speaker 3

Yes, Mike, I think that's still several quarters out. I would think we would be actually, we're collecting the The data to be in a position to do so, but I don't think that's going to happen until the end of 2024.

Speaker 5

Okay. I understand. And then just on the Check Your Food Tube events, I mean, it's good to see the traction there. But I'm just wondering about kind of the scalability of that, as you grow and do more tests. I mean, is that something that you can kind of scale with the company?

Speaker 2

Oh, definitely. I think, I thought you were going to ask the other question about whether it's sort of cannibalizing our core business, but we love the Check Your Future event. They are highly efficient. This kind of the input into a large number of tests that come out of these events in terms of the Person hours of sales interaction as well as, the efficiency of having our nurse practitioners or other clinicians perform the EsoCheck is Highly efficient and so it's very scalable. I mean you typically will have an engagement with, let's say, a fire Department in a location as our prototypical example, that's a rep, but maybe their area director working with them to get this organized.

Speaker 2

We A single person on the sales team that coordinates all of these in a fairly efficient fashion. And then when they're scheduled, We have one of our nurse practitioners or other device administrators come in and they're doing 50 in a day. We'd love to have that in the more traditional environments where we're engaged sort of more in the trenches with physicians. So It really is a highly efficient and absolutely very scalable way to do this. But again, I just want to be clear, This wasn't your direct question that our approach to this remains all of the above.

Speaker 2

Everything we can do whether it's our In the traditional in the trenches door to working with physicians and institutions, working through these health events, working with Employers and unions and other self insured entities, we're attacking it on all fronts anywhere we can enhance patient So, yes, it does remain it is a very attractive modality And an efficient one that is definitely scalable.

Speaker 5

Okay, got it. And then just finally, now that you've got You're close to having some of the clinical utility data. Do you have any plans to go back to Medicare? I understand that you're Focused on the payers and employers and things like that, but Medicare is a big opportunity. So any plans to go back to them and what Sort of the timing of that or is there some kind of cycle there that you have to wait for or something?

Speaker 5

Thanks.

Speaker 2

Yes. So I think so yes, as you know, we've made some Substantial progress, Sarah. We have 2 published, of 2 of the 3 clinical utility studies are published and so we'll wait till the 3rd. But the way we engage with Medicare is somewhat different than the way we engage with payers, right? The payer process is kind of more blocking and tackling pilot programs, Small and regional plans, larger plans, it's sort of a continuous process.

Speaker 2

With Medicare, it's much more binary. And so We will wait till we have all our ducks in a row, have all of the clinical utility studies published in the peer reviewed literature. We'll have some initial conversations with them in the first half of next year about how to structure our submission under the existing LCD. And we may wait till later in the first half to get the results of our Additional clinical validity study, the BE2 study that's actively enrolling. And so, yes, we'll engage with them in the first half of the year to plan that out and work towards a submission of the full package of the clinical utility and clinical related data Sometime late in the year.

Speaker 2

So that's an active process, but it's qualitatively different than The more incremental processes that we're working with the commercial payers. And as you noted, just to reemphasize, a key missing element there had been The clinical utility data now that we have that moving forward and locked down, Our opportunity to reengage with MultiX is, those approaches.

Speaker 5

Okay, great. Thank you.

Speaker 3

Thanks, Mike.

Operator

Our next question comes from Mark Massaro with BTIG. Please go ahead.

Speaker 2

Hey, Mark. Hello, good morning.

Speaker 6

Hey, guys. This is Vivien on for Mark. Thanks for taking the questions. Good morning. Good morning.

Speaker 6

It's nice to see the progress with establishing claims history and clinical utility data, I guess supporting conversations with commercial pay. You called out the revenue cycle management as well. I guess, how should we think about remaining levers to pull for ASP improvement? What kind of growth we could see off of Q3 ASPs? Thanks.

Speaker 2

Yes, Devin. ASP.

Speaker 3

Yes. So the ASP growth is really just a matter of the collections Against the submitted claims. First off, our price for test is just under $2,500 Medicare rate Just under $19,000,000 or just that $19,000,000 And we think that those numbers will continue to hold for us as We go forward as the benchmark to be paid against. We're all in out of network and at the allowable amount of $18, just under $1900 for kind of out of network, not in coverage policies by the private We think that's an indication that that becomes a pretty good floor for us. So in terms of Actual revenue recognized divided by number of tests delivered in a quarter, we think that ratio changes Purely based upon collection and the movement in the market access from out of network to in network over time.

Speaker 3

So I think that's So where you're aiming at in terms of ASP getting to that benchmark, but we don't see that benchmark eroding at anytime soon.

Speaker 2

So sort of a qualitative response to that is that the levers are what we're doing on the coverage side, which is utilizing the clinical utility data now that it's coming out, Engaging with payers on pilot programs and a variety of other ways to kind of leverage that data and actually get in network coverage As we are improving collections and with the processes that Dennis mentioned. So the levers are really focusing on medical policy coverage As the RCM, the revenue cycle management activity is improving and gearing up.

Speaker 6

Okay, perfect. That's it for me. Thanks guys.

Speaker 2

Thanks, Adrienne. Thanks,

Operator

comes from Ed Woo with Ascendiant Capital. Please go ahead.

Speaker 2

Good morning, Ed. Yes, congratulations

Speaker 7

on the quarter. As you guys continue to have consistent High growth and scale up the testing business in the U. S. Have you thought about international opportunities?

Speaker 2

Yes, that's a great question. That comes up a lot. I think I might have mentioned this on previous calls. We have previously done an analysis In Europe, the EsoCheck has CE Mark and we have the ability to run the assay there. Europe is very tough for molecular diagnostic screening tests.

Speaker 2

Some of the genomic profiling tests and so forth have a strong presence there, but even Tesla, Cologuard and others have struggled in Europe because the overall reimbursements there are low. We've had some discussions about Canada And that's really been our focus at this point. So we get occasional input from other parts of the world, but that's Not been a major focus right now. We're really laser focused on the U. S.

Speaker 2

Market.

Speaker 7

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

Speaker 2

Yes. Thanks a lot, Ed.

Operator

This concludes our question and answer session. I would like to turn the conference over to Doctor. Aklove for any closing remarks.

Speaker 2

Great. Thanks, operator, and hey, thank you all Thanks for your attention this morning and thanks for all the great questions. It's always enjoyable to discuss The results, as I said, we couldn't be happier with how with this quarter. It's really as a result of incredibly hard work that's laid the groundwork on clinical research, on our laboratory and market access team and so forth and we're looking forward to a bright future for Lucid and its technologies. We look forward to continuing to update you on our progress through press releases and follow-up calls.

Speaker 2

And as always, feel free to contact us through mikeparksmetpavmed.com and to follow us on social media. So thank you all and have a great day.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Powered by Quartr

Key Takeaways

  • Lucid achieved a 17% quarterly and 137% annual increase in EsoGuard test volume, performing 2,575 tests in Q3 and recognizing $783,000 in revenue—a 400% quarter-on-quarter and 1,000% year-over-year rise.
  • Upgraded revenue cycle management with QuadEx has driven a ~39% claim allowance rate at ~$18.63 per test, boosting weekly collections by over 30% and positioning Q4 revenue above $1 million.
  • Published clinical utility data from 1,500+ patients across three studies demonstrated near-perfect concordance, strengthening payer negotiations and major society guideline support.
  • Launched direct contracting with employers, including the first self-insured plan, and expanded “Check Your Food Tube” events to firefighter and police cohorts, enhancing scalable outreach and prevention.
  • Introduced EsoGuard 2.0 with multiplexed assay and higher-throughput sequencing to improve performance and reduce COGS by ~10%, while maintaining 90%+ gross margins and 7–9 day turnaround.
AI Generated. May Contain Errors.
Earnings Conference Call
Lucid Diagnostics Q3 2023
00:00 / 00:00