Welcome to the Lucid Diagnostics business update and fourth quarter 2022 financial results conference call. At this time, all participants will be in a listen-only mode. Later, we will conduct a question and answer session. I would now like to turn the call over to your host, Michael Parks, Vice President, Investor Relations. Mr. Parks, you may begin, sir.
Thank you, Paul. Good morning, everyone. Thank you for participating in today's fourth quarter 2020 business update call. The press release announcing our business update for the company and financial results for the year ended December 31st, 2022, is available on the Lucid website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The business update, press release, and this conference call both include forward-looking statements. 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 risks and uncertainties that may affect future operations, see Part One, Item One-A, entitled Risk Factors in Lucid's most recent annual report on Form Q-10 filed with the SEC, and subsequent updates filed as quarterly reports on Form 10-Q, and any subsequent Form 8-K 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. I would like now to turn the call over to Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics. Dr. Aklog?
Thank you, Mike, and thank you everybody for joining us this morning. I look forward to giving a positive update on our activities for the past quarter and recent weeks. As those of you who've been with us for a while have noticed, we've changed the timing to hopefully better serve our shareholders to have our quarterly calls in the morning prior to the open and our press releases the evening prior. I'll start with some recent highlights before doing a bit of background and then diving further into details. We're really excited about the steady significant strides we've made over the past quarter. As you'll see, the EsoGuard test volume growth has remained strong, and we've seen some nice acceleration, particularly in this quarter.
A rapidly increasing satellite Lucid Test Center activity that is now driving nearly 1/3 of our testing volumes. We're very excited to report that we've secured an in-network EsoGuard contract with the largest secondary PPO MultiPlan, and this provides access to EsoGuard to approximately 60 million consumers that participate in their networks. Our commercial payer engagement and claims history is accelerating. In-network EsoGuard contracts are now averaging over $2,000 per test, and all of the CPL contracts we've secured are priced at or above the Medicare rate. I'll dive into this a little bit further later, but we've launched a really important initiative for us. We're calling it our direct contracting strategic initiative, and the goal here is to engage directly with large ASO, or administrative services only, self-insured employers, unions, and other such entities.
As we reported in the press release, we had a successful launch of our high volume Check Your Food Tube event. We have a robust near-term pipeline of additional events coming up in the next month or two. Our laboratory, we're very proud to say, handled the unexpected record peak volumes from these events. This reflects a lot of effort we've made in enhancing our operational efficiencies. We received FDA clearance to market a non-sterile version of EsoCheck. This increases our margins and mitigates potential supply issues associated with sterilization. We're making good progress collecting clinical utility data, which is a key driver of future in-network commercial payer contracting.
As we'll describe in more detail, we've secured financing of just under $25 million, which extends our cash runway well into 2024. For those of you who are new to the story, I took a few slides here to give you some background. Lucid Diagnostics is a commercial stage cancer prevention medical diagnostics company, and we're focused on early pre-cancer detection, specifically in patients with longstanding chronic heartburn or gastroesophageal reflux disease, also known as GERD, who are at risk of developing highly lethal esophageal cancer. Our mission is very simple, which is it is to prevent deaths from this cancer in at-risk patients with chronic heartburn. The data on esophageal adenocarcinoma is awful. It's highly lethal and it continues to become more prevalent.
About 16,000 deaths in 2021, a similar number with a slight uptick in 2022. The incidence has increased 500%, far outstripping all other cancers over the last 4 decades. It's a very, very lethal condition. It's the second most lethal cancer with an over 80% 5-year mortality rate. Most importantly, the stage 1 5-year mortality, so right at the early stages, it still carries an over 40% mortality rate. In order to have an impact on those deaths, early pre-cancer detection is necessary.
That's not currently occurring, it hasn't historically occurred. Less than 5% of those patients who are recommended for screening are undergoing traditional endoscopy. That's where we come into play. Our lead products, EsoGuard and EsoCheck, are the first and only commercially available test that's capable of serving as a widespread screening tool to prevent esophageal cancer death through the early detection of esophageal pre-cancer. EsoGuard is an esophageal DNA test that uses next-generation sequencing to detect early changes in the precancerous conditions as well as cancer. EsoCheck is a non-invasive cell collection device that allows samples to be performed accurately in an in-office setting.
We were very proud last year and very excited that both major gastroenterology societies, the American College of Gastroenterology, American Gastroenterological Association, now support EsoCheck as an alternative, an acceptable alternative to endoscopy for the early detection of this pre-cancer to prevent deaths from this cancer. The commercial opportunity here is large. The minimum at-risk population defined by these guidelines, the most recent updated guidelines, is 30 million. Medicare has established payment of $1,938, and we'll show later that payment flow is being respected and that results in a very large addressable market in the tens of millions of dollars.
We also have a very high gross margin at over 90%, and we've made some progress we'll highlight again in getting our COGS down and getting us towards that 90%, or greater number. Our commercial strategy is now really very well-honed. We have 2 referral sources that we target, primary care physicians and specialty specialists and institutions. You can see here that our interaction with them is different. When we discuss with primary care physicians, we're just encouraging them or educating them and then encouraging them to order the test as they would any other cancer screening test or like stool DNA testing or any other test.
With the specialists and with the institutions, there's an opportunity to build a consolidated program, centered around EsoGuard that's focused on esophageal cancer, pre-cancer, and gastroesophageal reflux disease. We also now have three modalities where the cell collection procedure is performed, where the EsoCheck procedure is performed, and the operators differ. We have our physical Lucid Test Centers, which are now at 13 locations in 11 states, and our own nurse practitioners perform testing there and that continues to remain robust. In the last couple of quarters we've steadily expanded what we refer to as our satellite Lucid Test Centers, where our nurse practitioners have scheduled days at physicians' offices, and they can perform the EsoCheck procedure on patients who are already scheduled at the physician's office.
This provides a very attractive expansion in our physical reach and our overall horizons. Then of course, at these, particularly at the specialists and the large institutions, the physician practice itself will often perform the procedure, either one of their nurses or nurse practitioners or their physician assistants. We continue to show nice steady growth in EsoGuard testing volume. Here are the numbers by quarter. We're reporting the estimated numbers for this quarter as we're now quite close to the end of the quarter. You can see, you know, on an annualized basis, we're at a steady approximately 200% per year compounded growth rate.
To dive in a little bit deeper on where this testing is occurring and where these referrals are coming from and who is performing the procedure, we continue to have about 60% of our referrals are coming from primary care physicians that we think that will continue to be the case and that might up, might tick up over the coming quarters. This is good because that's where most of these patients are. Patients with gastroesophageal reflux disease are rarely seen by specialists or institutions, and they're generally managed by their primary care physicians. Another important trend is highlighted in the right pie chart. This is a breakdown of who's actually performing the EsoCheck cell collection procedure, and you can see that and where.
You can see that 29% of these are at our physical Lucid Test Centers, 31% are in the satellite Lucid Test Centers. If you recall, both of these, 60% of the samples being collected, are being collected by our nurse practitioners in one of these venues. The proportion that are of the overall number, that 31% that are being performed at satellite Lucid Test Centers is steadily increasing. It was 22% in the third quarter. We still have a robust activity as well in the individual physician practice. We launched another horizon, another location and opportunity and model for our patients to get to bring EsoGuard testing directly to at-risk patients in high volume events that we're referring to as Check Your Food Tube pre-cancer testing events.
The first event was highly successful. It was done in partnership with the San Antonio Fire Department. You could see in the images there, that's our nurse practitioner, working with the fire department, a nurse practitioner team and others working with the fire department to test 391 at-risk firefighters over two weekends. This was quite successful. The tests were all performed and we've seen positives. We've seen positive results that are leading to endoscopies in patients, including patients in their forties and a few in their thirties.
We're excited that those patients have had the opportunity to get a non-invasive biomarker test that if confirmed on endoscopy, will put them in the proper surveillance and monitoring regimen to prevent them from developing esophageal cancer. We're taking this model and we're rinsing and repeating. We have a robust near-term pipeline of future events targeting unions and other groups across the country, and we expect to be updating you on these in the coming months. This, as I mentioned, is a very important area of focus for us, and we'll be doing this in conjunction with the direct contracting strategic initiative that I previously mentioned. As I mentioned, we're very excited to have signed an in-network agreement with MultiPlan.
Multiplan is the largest secondary preferred provider organization and one of the largest independent providers outside of the large health plans. This expands EsoGuard access to approximately 60 million customers. Multiplan partners with 700 payers across the country, including all of the top 10 payers and 1.2 million healthcare providers. They processed $74 billion in commercial health plan medical charges in 2022. If you look overall at our contracting and payment status, really solid progress in this regard. The engagement we're having with commercial payers is accelerating. As you see on the right in the pie chart, we continue to have nearly 90% of the tests being ordered and performed are on commercial payers, so that's where our immediate focus is.
We have 13 commercial payer in-network contracts for EsoGuard that we've secured. The really gratifying point here now we've done enough of these is that the price is holding. Our average contracted price is over $2,000. Our list price is $2,500. All of our contracts are somewhere between the Medicare. The PPO contracts are somewhere between the Medicare payment rate of $1,938 and our $2,500 list price. Those are for in-network contracts. For out-of-network contracts, the out-of-network payments. Out-of-network payments, they continue to respect our charges. The average payment is $1,440, that lines up nicely with about a 50%-60% out-of-network benefit that's controlled with most plans.
The key drivers to expanding future in-network commercial payer contracting are progressing well. These 2 primary drivers are generating claims histories. We are now generating claims histories. We have hundreds of claims with many of the large, the larger plans. This is how Once you reach a threshold, this is how you have the opportunity to engage with these plans on potential in-network coverage and what data they need in order for us to secure that in-network coverage. We're also starting to see claims that are working their way through the denial process and appeals process, and we have been seeing some payments that were initially denied, paid on appeal.
I'll remind you that this entire process of submitting claims through our own laboratory only started in mid third quarter, so we're just still in the early stages of this, but the progress is really gratifying. We're also in the process of generating the primary focus of the commercial payers, which is demonstrating clinical utility. I'll show a little bit later what that entails. So good solid progress on that. As I mentioned, we've launched a direct contracting strategic initiative. This involves engaging directly with entities, self-insured entities, such as employers, unions, public service departments, and others who are under the ASO umbrella. They have only administrative services through one of the plans, but they control their own destiny.
Directly engaging with them provides the opportunity to secure contracts that are outside of the traditional commercial payer contract and an opportunity for meaningful revenue. This model of targeting ASO entities has been used successfully by other cancer detection companies such as Grail, Inc., and we're studying their models and working closely with their alumni as well as with other consultants to help us quickly drive this initiative, which we think will be an important part of our future activity. I'd mentioned clinical utility data. Again, this is extremely important. The larger plans do want to see that there is clinical utility in performing EsoGuard tests. The definition of clinical utility is very straightforward in this case.
They want to know that if the physician orders the test, and it comes back positive, that the physician will alter medical decision-making, specifically that if it's positive, the physician will order a confirmatory endoscopy, and if it's negative, that the physician will not order an endoscopy. Documenting this very simple fork in the medical decision-making algorithm is very important to justify the coverage of these, of this test for payers. We're in the process of collecting a multi-pronged approach to collecting retrospective and prospective data, documenting positive clinical utility with the EsoGuard test. These are in rough order of when we expect the results to come out.
The one of the nice things about these Check Your Food Tube events is that we have an instant shot of hundreds of patients that we can analyze. This initial one is, well, a retrospective analysis of prospectively collected data on what happened to the firefighters who got tested and how did their testing lead to the appropriate medical decision-making. This study has completed IRB approval, and the data is now all in place, and it's being analyzed and will be submitted shortly for peer review. We also have a retrospective study that's well on its way and nearly completed.
This is a single center study from NYU that had 374 patients that were collected and will analyze decision-making and clinical utility. We expect that to be completed and submitted for peer review shortly. The two prospective efforts that we have is our Lucid Registry. We have some significant breakthroughs in terms of streamlining that process. We expect now every patient that is tested by one of our nurse practitioners to be offered the opportunity to enter into the registry. This will allow us to collect both clinical utility data but also clinical validity data into the future. The CLUE study is a prospective multi-center clinical utility study as well, which has started enrolling. We're looking to get a critical mass, a critical number of patients across these studies.
You can see the numbers on the right here, by mid-year next year. Finally, there's a prospective virtual patient randomized controlled trial where physicians are interviewed and receive case vignettes, and they're asked how they would respond to that. That's a well-validated approach that payers have accepted in the past for clinical utility, we're adding that to the mix as well. It will expect to enroll about 140 patients in that. I apologize. I understand that the slides were not showing. Okay. Let me just spend 20 seconds on each of the slides just to highlight again. This slide is the commercial payer mix, 90% commercial payers and 12% Medicare/Medicaid. Apologize for that.
Here is the slide on the clinical utility data that I just summarized, showing the retrospective and prospective studies and the number of patients that we're targeting to enroll by mid-year this year. I apologize for that. A quick summary on our lab operations. Again, very proud and excited that our laboratory continues to show enhanced operational efficiencies. Probably the most important number from this slide is the proportion of samples that have sufficient DNA. That number has plummeted. It's running around 6% now from a much higher number when we first took over the laboratory from the third party. We look forward to continuing that low rate moving forward. That provides much more utility when we get those numbers down low.
Our turnaround times have remained solid over the last couple of quarters at 9 days. The Check Your Food Tube event with the San Antonio firefighters was sort of a spontaneous stress test for our system, and it the team passed with flying colors. They were able to perform 100 EsoCheck procedures in a day, with 50 per day by the nurse practitioners. The laboratory received on 1 day 200 samples and was able to process that all in 1 day with our current infrastructure. Just finally, some updates on the manufacturing side. As I mentioned at the beginning, we submitted EsoCheck for market clearance and received the 510(k) to be able to market it without sterilizing. This is a non-sterile procedure.
This is going into the mouth and the esophagus. The purpose of this was to enhance many aspects of our operation. As you see, it further reduces our COGS by approximately 10% after a substantial decrease in our cost of goods from transferring to high volume manufacturer. Our lead times have been cut dramatically. The sterilization has become across the industry a major source of supply chain issues and constraints that's been eliminated. EtO sterilization is a hot topic right now with environmental issues, and we've obviated that being a factor in our testing. We also have a new EsoGuard cell collection kit with a new manufacturing site, a new improved design, and the cost of goods for manufacturing these has also decreased by approximately 20%.
With that, I'll pass on the slides to Dennis to talk about our financial update.
Thanks, Lishan, good morning, everyone. If you go to the next slide, Lishan. The board has authorized a $20 million preferred offering and an $11 million secured convertible debt. We completed the initial closing of the preferred in the amount of $14 million and have until the end of May to complete the remaining $6 million. The financing was priced in accordance with Nasdaq's at the market closing bid price rules. The accredited investors were led by a family office familiar to our IR firm and some long-term high-net-worth shareholders, four participants in total that share a long-term vision for the company. After exploring a variety of alternatives, this preferred structure created a mutual win for the company and the investors by matching an attractive dividend with a strong incentive to hold the stock for more than two years.
Yesterday, we entered into a securities purchase agreement to issue $11 million in convertible debt securities with an accredited investor that has provided the same type of structures for PAVmed over the years and currently holds PAVmed's existing debt with similar terms. We expect to close the funding in the coming days. The note is interest-only for 6 months and has a $5 voluntary conversion price and a 7.9% interest rate. Amortization does not begin until the 6-month anniversary, which we can then pay in cash or in stock. Both structures keep stock out of the market for long periods of time, likely 2 years in the case of the preferred, which allows the company to complete its work on clinical utility studies and proving reimbursements. Our runway is substantially elongated through deep into 2024.
On a pro forma basis, when combined with our cash at the beginning of the year, results in pro forma cash of approximately $46 million. For the fourth quarter, the change in cash from the third quarter was four and a half million dollars. Please refer to the 2 Form 8-Ks that were published last evening for additional details on both financings. The summary financial results for the fourth quarter and the year that we reported in our press release that was published last night will be corrected as the tables reflect PAVmed's consolidated operations instead of the standalone Lucid financials. We apologize for that. We will be publishing PAVmed's release this afternoon, which include both PAVmed consolidated and Lucid standalone.
On the next 3 slides, I'll emphasize a few key highlights from the quarter, but I'd encourage you to consider those remarks in the context of the full disclosure covered in our annual report on Form 10-K that was filed with the SEC last night and is available on our website. On the balance sheet, you see the year-over-year changes, but the cash as mentioned from the 3rd quarter to the 4th quarter was a $4.5 million sequential decrease, and it was $30 million for the year. Vendor payables were relatively flat for the sequential quarter and for the year, offset by intercompany debt to PAVmed, which increased to $3.3 million at 12/31, and both boards have authorized the ability for Lucid to pay that in stock rather than cash to preserve the cash at the Lucid level.
Shares outstanding, including unvested RSAs as of today is 43.4 million shares. The GAAP outstanding shares are reflected on the slide as well as the face of the balance sheet in Form 10-K. Next slide. Slide 20 compares this year's fourth quarter to last year's fourth quarter on certain key items as well as year-over-year comparison. 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 the non-GAAP information. Revenue for the fourth quarter reflects actual cash collections for the quarter. The prior year reflects the fixed monthly fee received from a third-party lab that we used before setting up our own lab earlier last year. Revenue recognition, a key determinant is the probability of collection, as we've mentioned in our calls in the past.
For the vast majority of patient out-of-network claim submission means revenue recognition occurs when the claim is actually collected, and we're in the early innings of that, versus when the patient report is invoiced and submitted for reimbursement. As you will see in our 10-K, 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 invoiced. Our GAAP and our non-GAAP loss for the fourth quarter, ten and a half million, is fairly flat compared to the third quarter loss of $10.2 million. Slide 21 is a graphic illustration of our operating expenses for the periods reflected. Total non-GAAP OpEx was relatively flat sequentially. Cost of revenue primarily consists of EsoCheck devices, lab supplies, and fixed lab facility costs.
It is being presented in our 10-K and 10-Qs as operating expense consistent with practices of other diagnostic companies. Sales and marketing increases were offset by decreases in R&D and G&A, which allow the operating expenses to be relatively flat. With that, operator, let's open it up for questions.
If you would like to ask a question, please press star one on your telephone keypad now. You'll be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you have a question, please press star one on your phone now. Our first question comes from Kyle Mikson from Canaccord Genuity. Your line is open.
Kyle, good morning.
Good morning, Kyle.
Just one moment. Seem to be having a little technical difficulty. All right, Mr. Mikson, your line is open.
Hey, guys. Can you hear me now?
Yeah, we can. Mm-hmm.
All right, perfect. That's interesting. Yeah, congrats on the results. Thanks for the questions. On the effective ASP here was $95. It seems like the denial rate for reimbursement seems like, you know, still pretty high. Cash collection is pretty low. It's not, like, super surprising, I guess. You know, just the ASP dynamics, though, you're talking about a out-of-network $1,400 payment and then commercial payer is $2,000, TPO is at the Medicare rate, which is like, you know, almost $2,000 as well. Would you mind just walking through why the revenue per test is so low and when that inflection point occurs and what kind of, like, catalyzes that?
I'll let Dennis dive into that deeper, but maybe just provide a high level. You know, this is a bit of a moving target, right? Because the average life cycle of the cycle for a payment can run up to 90 days. There's claims adjudication, appeals, and so forth. What we're seeing in any particular quarter in revenue is really a snapshot of what was going on with claim submissions a while back. I'll let Dennis dive a little bit further into that.
Correct. As Lishan indicated, the submitted claims do take some time to process, and beginning in the fourth quarter, those amounts start to trickle in. There was more than 200 insurers that were billed, claims. Leading up to the fourth quarter and into the early part of the first quarter.
In the first quarter, we are starting to collect at an accelerated pace. It's still early in the game, and claims are being adjudicated both from a denial, an appeal, as well as asking for additional information. That steam will pick up as the year unfolds. The fourth quarter is not indicative of what the first quarter results are so far, and we expect that the coming quarters, that reimbursement will improve. MultiPlan certainly helps with that endeavor as well as we are getting paid from some of the larger players, United particularly, and we're getting paid at out-of-network rates.
That backlog should continue to pick up, and so that ultimately, we're hoping that in time, when we get to fuller reimbursement, there'll be a match in terms of when the claims are submitted and the cash is collected. For now, there is a large gap between those time frames.
If I could just add a couple of things, just to again emphasize the sort of the phase shift here. We started submitting claims in the end of August, basically, mid to late third quarter. The fourth quarter results, if you kinda take that typical 90-day cycle, and those cycles are longer for new tests. When those tests are more established, the turnaround time is simply longer. The fourth quarter numbers really reflect a small portion of the claims that were submitted in only half of the third quarter. The other point I would make is, again, these are early numbers. We don't have good denominators on this, but we don't have. We, you know, the number of. You sort of mentioned the denial rate.
There really isn't a denial rate yet because the number of claims that have gone through the full adjudication process and have been denied is very low right now. Most of the claims are either have either been paid or more likely, the vast majority of them are still working their way through the process.
Okay, that was really helpful, guys. It sounds promising too. Maybe just sticking on a similar kind of subject, it really good to see the kind of projection for the first quarter, you know, tests performed here, like 1,600. Looks like, I think, I believe that 36% growth sequentially. That's awesome. Any reason why that type of sequential growth can't continue going forward or potentially, you know, accelerate from there? Is there anything about maybe seasonality or other dynamics that could maybe inflate that 1Q number? I mean, it sounds very reasonable, but just, you know, just trying to think about how that progresses throughout 2023.
Yeah. No, I think, you know, if you look at that slide, there's a bit of seasonality you saw in the fourth quarter, and that's common, as you know, Kyle, from other companies. We also in the fourth quarter had to work through some compliance structure, establishing some compliance structure in a couple of our larger states as it relates to how to do the satellite Lucid Test Center. There's some pent-up demand in both Florida and California there that we're addressing. If you kinda look at the overall trend on the line, that 36%, you know, something like that quarter-on-quarter, about a, you know, 200% or so compounded growth rate, I think is sustainable for some period of time.
Obviously, the goal is to continue to grow that. I think you know, as we've said in the past, we're not, we're not on full throttle, right? We've decided to plateau our sales team and that sales expense that Dennis showed, we expect that to be flat for this year. We think our current team can continue to drive test volume growth as we start getting more predictable payment and improve on our contracting. We think these initiatives such as the high volume testing events as well as direct contracting with ASO type entities will you know, will play an important role in that growth over time.
Okay. All right. That was great. Yeah, similarly, just thinking about tests ordered per, you know, ordering physician, I guess, I know it's, you know, your test center.
Yeah
strategy is not on hold, but you're just sort of investing in your current number, I guess, of centers. MultiPlan, you added, you add some providers there as well, and some physicians will get on board, and I suppose, and start ordering more and more. I mean, that base, that denominator number is sort of, you know, is still pretty healthy. I'm just wondering if tests per doc is increasing, how that's progressed through the since the launch in 2021. Is there a plateauing?
Yeah.
Like, just any kind of trends. Yeah.
I mean, what we're focused on, I don't have a sort of a single number to give you to capture that. What we're focusing on, we have a good number of providers. We have, as you mentioned, breadth geographically now, and the fact that we can do satellite test centers has given us, you know. We're not, just to be clear, we're not putting the physical locations on hold. They still remain an important anchor and are key in areas where we, as sort of the headquarters for our clinical team, our nurse practitioner team.
The fact that they can branch out both within their local geography and literally get on a plane to go to San Antonio and do 400 tests at the weekends, you know, all of that is enhancing our geographic reach and the number of providers. We have a very focused effort right now by our sales team to focus on stickier business, on having accounts continue to order on a clip. The reps are now increasingly incentivized along those lines. It's working. We have figured out ways. You know, the issue with repeat ordering and stickier business is not about sort of loss of interest, it's just more a matter of attention.
I think I've mentioned this before, but I'll reiterate it. One of the things that we really like about the satellite model is by having a day where the Lucid nurse practitioner is gonna come to the practice on a particular day does bring the whole issue of pre- esophageal precancer testing front and center. If they know that the NP is gonna be there, you know, next week or in a couple of weeks, it's much more front and center than previously, where we had to just have multiple contact points by our reps to keep it front and center. Yeah, again, don't have hard data on you on that, but the trends are actually are good. We are getting stickier business, but we're also. We're doing both.
We're trying to get breadth and depth at the same time, while keeping, kind of a mid-throttle approach until we get more predictable reimbursement.
Okay, just one last one before I hop off. I guess on FDA, obviously there's been a lot of back and forth, but it does seem like FDA is going to push towards regulating LDTs, like, in the near future, I guess. I know you delayed the BE-1, BE-2 trials, but what would happen to your ability to offer EsoGuard in the event that the FDA starts to kind of crack down on tests in the next, you know, 1 or 2 years, 12, 24 months? What's the plan B here?
We're monitoring the VALID Act as well as the FDA's recent declaration around rulemaking in this area carefully. We don't have any concerns in the near term. These are all long-term. That's certainly not one or two-year events. There are grandfathering clauses. We have confidence with regard to where we will align in our risk assessment, and we think we'll have the appropriate data to be able to continue on it uninterrupted. We're monitoring closely. We've established long-term strategies to mitigate that. On the clinical validity side, we will start getting clinical validity data.
I should mention that there are other sources of clinical validity data from the BETRNet study, the NCI-sponsored studies that were anchored by the BETRNet Consortium that centered around Case Western Reserve. Those studies are collecting data. They're starting to get critical masses of data with good results, and we should starting to see those come online in meetings and in peer review publications well before we have our BE-2 data out. We'll monitor that, but we don't have any concerns in the near term about it.
Perfect. That's great, Lishan. Thanks, guys, for the questions. Appreciate it.
Thanks a lot, Kyle.
Thank you. Our next question comes from Ross Osborn of Cantor Fitzgerald.
Good morning, Ross.
Hi, Ross.
Hi. Good morning, everyone. Generally a couple calls, so I may have missed this. Where did you end the year in terms of sales reps, and what are the hiring plans for 2023?
We had 40, which is what we had said we would target in our strategic update call in January. That reflects some layoffs and some backfilling, but we've settled in at 40 sales personnel as well as the clinical support team, the nurse practitioners and clinical specialists. We've added a couple to that to make sure we have sufficient coverage there. The plan right now is to maintain that flat through the year and to allow this team to continue to drive the type of test growth volume that I just talked about with Kyle. Certainly there'll be opportunities to dial that up if the reimbursement side accelerates more quickly than, but we're prepared to keep that flat for now.
Okay, great. I realize the focus is now on satellite testing, at least for the near term, but could you discuss your geographic presence relative to your original stage geographic rollout? As a follow-up, what can you do to accelerate satellite testing activity?
Yeah. I just want to kind of maybe restate, just to make sure there's no misunderstanding here that there isn't, we're not shifting or we're not pausing the physical test center model. It still remains our anchor. That's where our nurse practitioners are physically based, but they have the opportunity to move and do tests in a broader geographic area. It really is sales coverage right now, and our sales team coverage is broader than the 11 states and the 13 test centers the physical locations that we currently have.
There are opportunities, for example, in Georgia and other states where we don't have physical Test Centers where there is increasing activity that we could support using nurse practitioners using the satellite Test Center model. Certainly we're not, with 40 reps, we're not covering the entire, you know, every single state or every single metropolitan area. The geographic coverage is broader, and it, and it certainly covers the major states, particularly California, Texas, and Florida, Ohio. Those are big remain big locations for us.
Okay, great. Thanks for taking our questions.
Okay. Thanks, Ross.
Our next question comes from Mike Matson of Needham & Company. Your line is open.
Morning, Mike.
Hi, Mike.
Yeah. Good morning. Just a question on the CYFT event, you said you did, like, 391 tests there. Is that included in the test number, and do you expect to get paid for those tests?
That's an interesting question. Yes, they are included in those numbers and they're, these are commercial patients who have commercial insurance and it's not a research project or anything like that. We do count them in the commercial numbers. We don't know yet. It's an interesting dynamic because generally, for example, with a typically with a firefighter group, the firefighter union is often an ASO, so they have their own decision-making opportunities. You might expect that our ability to engage with them directly... That's why I was saying that the CYFT events are tightly linked to our direct contracting initiative, right?
Because we're dealing with typically in organizing these on the logistical side, dealing with the firefighter team and the unions in particular. As we're expanding what's a quite robust pipeline, we're being much more proactive at the beginning about understanding the payer structure within each of these and working closely with the self-insured entity typically to set these things up. We don't know yet, but there's certainly some hope and some promise that the prospects of, you know, the payment rates, the percentage of claims that get paid as a result of these tests could be higher. That's our hope, obviously. It's an attractive aspect of this business because it's a, you know, large, high-volume event.
It's a good chunk of testing. We can handle that chunk of testing, and it's with a single entity that our engagements with these entities, with the firefighters in particular, have been extraordinarily positive. They understand the need. They're very focused on protecting their members. It's a very different dynamic than a typical than an engagement with a typical health plan. We're quite optimistic. I'm glad you brought that up, but we obviously, you know, have to demonstrate that.
Okay. Understand. I think Dennis said the cash that you used, about $30 million of cash in 2022, is that right? With the announcement earlier this year of the cost reductions, I think you said you'd reduce your cash burn by about 25%. That would seem to sort of imply like a low $20 million number for 2023. Is that reasonable?
Yeah. The burn rate for the first half is gonna be in the $7 million-seven and a half million range, and then should gradually decrease as operating expenses continue to remain flat and the collections we are estimating will start to improve at a significantly higher rate that, you know, will bring the burn down for the second half of the year to a larger number.
Sorry, the 7 to 7.5, that's a quarterly number?
That's for that.
But, but that entire-
That's a quarterly number.
Quarterly number. Okay.
Yeah.
All right. Got it. So with MultiPlan, the covered lives, how do those... I guess the geographic concentration of that sort of match up to your sales force and test center locations?
They're not. MultiPlan is national. They're in every corner of the country. Our market access team does have a robust process whereby they look at where payers are and how that aligns with our team. That's a process that we utilize. In some of the other contracts that we've had, those are regional and that's much more actionable. MultiPlan is really a national plan. They have their primary PPO network, a complementary PPO network, so there's lots of opportunities to engage all across the country.
Okay, got it. Then finally, apologize if you mentioned this earlier, and I missed it, but MolDX, I mean, you've discussed the clinical utility efforts, but, you know, when do you think you could make, you know, take another shot at getting MolDX coverage?
Just to be clear, there's no other shot. The shot is already out there. We're just waiting. Yeah. There's nothing more for us to do. We went through the process last year where upon publication of the draft LCD, we participated both with MolDX as well as with Noridian, the MAC that covers our laboratory, through the open meeting process as well as the comment period. Once that's submitted, there's nothing for us to do. It's just a waiting game. It's on their desk. They're looking at it and they'll get back to us at their, at their time. If you recall, it took quite a while from the original submission to even get the draft LCD published. We make no particular predictions about when that'll happen.
You made a good point in that, in linking it to clinical utility. Our ability to respond to an updated LCD and seek, remember, these are foundational LCDs. They're general LCDs for the category of testing. To translate a foundational LCD into a specific LCD for Lucid, for EsoGuard, will require submission of clinical utility data. Until we have sufficient clinical utility data, which to respond to the LCD, which we won't have till midyear, the timing of the LCD right now is not actually hurting us because we won't be in a position to do the technical submission to convert it to a test LCD until mid-year.
You know, we're waiting, but the good news is, and the reason we're focused on the commercial side is that the demographics of the patients being ordered for testing remain strongly tilted towards commercial payers, you know, with 10%, 12% of the patients being Medicare. We'll just continue to wait on the Medicare side while we're pushing really hard, full steam ahead on the commercial side.
Okay. Got it. Thank you.
Okay. Thanks, Mike.
Thank you. Our next question comes from Mark Massaro from BTIG.
Hi, Mark.
Your line is open.
Hey, guys. Thank you for taking my questions. Yeah, you guys were very clear about what you need to do to show clinical utility. You know, the positives just need to get a confirmatory endoscopy and the negatives just need to not get one, you know, based on the clinician suggestion. Can you give me a sense and maybe confirm that, Lishan, that you plan to submit the clinical utility, was that midyear 2023? Can you give us a sense for the numbers? I mean, are we looking at like 100 patients, a couple 100 patients?
Yeah. I'm gonna go back, I'm gonna go back to the previous slide. I hope it'll still show. Yeah. Let's kind of do a deeper dive into this.
You might have to use the bottom.
Hold on 1 second. This technical glitch here. I gotta push it in the audience. Hopefully, you can see the numbers there. 1 quick minor correction to your summary, which is otherwise excellent, of what clinical utility means. It doesn't even mean that they have to actually get the endoscopy. People fall through, they fail to show up and so forth, you know, loss of follow-up and things like that. We just have to document that what the physician did. That the physician ordered the endoscopy or they did not order an endoscopy. Even in negatives, there are going to be times where an endoscopy is ordered for other reasons, right? But as long as an endoscopy was not ordered for screening for esophageal precancer, then that shows that demonstrates that clinical utility.
The numbers I show here are really intended to give you a picture of sort of the number of ways we're approaching this. I mean, this is an all-out effort, multi-pronged, you know, 5 different areas that we're focused on here. There'll actually be more because each new Check Your Food Tube event will be another batch of clinical utility data. The ones that are the strongest are the two, the Lucid Registry and the CLUE study. Those are the truly prospective studies which will garner us the most attention from the payers. All of them are important and all of them will be useful. Those are our estimates and our targets for mid-year, and we will be submitting data as they come in.
We don't have to wait, you know, for some specific number. Well, once we have a critical number of patients involved in each of these, we'll be able to submit interim data for peer review. By, you know, it's a little bit hard to know until we have a little bit better trajectory on the, on the projections here, but certainly by mid-year, I would expect that we would have some of the, particularly the retrospective and the CYFT data submitted and for peer review and published. The other ones may need a little bit more time. Right now with online journals, turnaround time for peer review is not terribly long.
These are just ballpark numbers, ballpark targets where we look to end up, and hopefully that makes sense.
MolDX is likely looking for approximately 200 individuals in a prospective observational study.
I think that's about right. You nailed it. We have right now targeted 400 patients in the true prospective studies, the CLUE and the Lucid Registry. We certainly will be able to combine those. You're right, because if you think about it, our positivity rate is about 7%-10%, and that's where you need the numbers from, right? If you have 400 patients, let's say, at a 10% positivity rate, that means there'll be 40 patients who are positive, and you can show that those 40 patients did not get referred for endoscopy. Then obviously the other 160 patients, that's a plenty large number to demonstrate that negatives are not...
Sorry, not 160, it would be 360 patients, that show, to show that the negatives are not getting referred for endoscopy.
All right. Perfect. Yeah, thanks for clarifying that the physician just needs to order it rather than the patient needs to complete the procedure.
Correct.
Cool. All right. My next question, the San Antonio Fire Department is really, really interesting because that's about 1/4 of your volumes in Q1, based on my math. You know, I think you noted in the press release that firefighters have a higher risk for GERD and esophageal cancer. I think you indicated that your near-term pipeline for future events is robust. You know, would love to hear just a little bit more about maybe what some of the other high-risk groups are, what your funnel looks like, and, how many of these you think you might be able to pull off in 2023.
Great. The pipeline is robust. We have, obviously, you know, what you're gonna focus on your successes first. The initial focus has been on other fire departments. As you mentioned, the key linchpin there is the published, well-established data of a 65% increased risk of esophageal cancer in firefighters based presumably on environmental exposure. There are a lot of firefighters, a lot of fire departments. We're picking up the phone and calling a lot of them, and we expect to start seeing more on those sides. As I mentioned, Mark, this sort of folds into kind of the broader...
There are certainly other higher-risk groups you can think of, other unions, you know, truck drivers, other, you know, policemen and other public service groups. This starts to kind of fold in or meld into the overall approach to direct contracting, right? To engage with entities that are very. One of the things we learned from engaging with the firefighters is, as I mentioned, they're very committed. The level of passion and commitment to their members is high.
Our ability to engage with entities that are self-insured, that where the conversation is a very direct one and one that is that drives that's driven by the commitment to do right by their patients is a big opportunity for us and something that we look forward to. I'm not really prepared to give you a sort of a number. I think right now we're gonna stick with, you know, our trajectories with regard to test volume. You know, we continue. Just to clarify something that comes up occasionally, this is not a pivot. You know, our traditional approach to primary care physicians and specialists and institutions, that's unchanged, and we continue to drive that hard.
We're certainly working on for figuring out, you know, how to do both logistically, but so far so good. We expect to see a good number probably in the next couple of quarters. We'll be able to give you a little bit more, you know, fleshed out targets as to what we look to do.
Okay, great. Maybe just my last question. You know, as we think about the rest of the year, great to see MultiPlan coverage. Just curious if you think you're getting... I know it sounds like the conversations with payers is improving and the fact that you're getting paid on some of the denials is excellent. These are relatively small numbers in early days. Do you think as the year progresses, you might be able to sign whether it's, you know, a large national commercial payer or at least some of the regional payers, you know...
Yeah.
How should we think about payer coverage?
Yeah. I think the lesson, there's two lessons. One is really wanna get this point home that the price is holding. I mean, I really feel like we now have enough that we can feel confident about, you know, that the price between Medicare as a floor and our $2,500 list price, based on out-of-network payments, based on payments from, as Dennis mentioned, larger plans that are out-of-network, that respect that price is really We're developing increasing confidence that our pricing is gonna hold.
On the, on the larger plans, our expectation, we've had multiple advisory board meetings and conversations, so we have a good finger on the pulse as to what the larger plans are gonna expect based on active and retired engagements with active and retired medical directors. The message is quite clear that in order to get larger plans, it's likely to require us to have that meaningful clinical utility later in the year. In the interim, you know, our conversations with the secondary PPOs, like MultiPlan and smaller plans, will continue. I think, like it's not a binary event, but I wouldn't necessarily project that we'll lock down one of the larger plans until we have some meaningful clinical utility here.
Okay. That makes sense. Thanks so much.
Great. Thanks, Mark.
As a final reminder, if there are any final questions, please press star 1 on your telephone keypad now. Our final question comes from Edward Woo from Ascendiant Capital. Your line is open.
Go ahead, Edward.
Congratulations on the quarter. In terms of the 40 salespeople that you have, what's the average tenure, and how do you characterize in terms of the, you know, productivity and whether there'll be room for improvement?
Yeah. That's a great question. I don't have a hard number for you, but, you know, it is certainly increasing now that we've plateaued the number. You know, probably about six to nine months is, I would say, the median. We have a good, you know, median. The median rep has now had a decent time in the field. As I mentioned on our previous calls, by plateauing our team, it's freed up the sales leadership to be more active in the field and more active in strategic accounts. We closed a large strategic account a couple weeks ago. That will just more time with them because they're not spending all the time on interviewing and recruiting.
That 6 and 9-month median number will obviously go up as the year progresses. We found that just more time in the field and more experience interacting with physicians and engaging with accounts and trying to make them stickier, obviously increasing the experience will help with that, and that number will go up steadily over the year.
Great. Well, thank you for answering my questions. I wish you guys good luck. Thank you.
Thanks. Thanks a lot, Ed.
We have no further questions in queue. I'll turn the call back over to our host.
Great. Hey, thank you everybody for taking the time and for spending the morning with us on our update call. We appreciate everybody's effort and everybody's support. Feel free to contact us with any further questions. You can get information on our website, luciddx.com, or by contacting Mike Parks at MEP at pavmed.com for any further questions. Thank you very much.
This concludes today's conference call. Thank you for attending. Have a pleasant day.