Dr. Lishan Aklog
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 third quarter 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 eight consecutive quarters of steady growth in test volume. We performed 2,575 commercial EsoGuard test which is 17% quarterly growth and 137% annual growth. Even more importantly, we recognized revenue of $783,000, which is a nearly 400% increase quarter-on-quarter and nearly 1,000% 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 traction 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. In 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 1,500 patients across three studies that have been released. The Clue Study, the PREVENT registries and our San Antonio fire department study. Two of these have been accepted for peer review publication and one is pending. We're accelerating our activities and 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. First, a couple of background slides here. A bit about our EsoGuard Esophageal DNA test. EsoGuard is the first and only commercially available test that's capable of serving as a widespread tool to prevent esophageal cancer death through early detection of esophageal pre-cancer. 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 would be insufficient in this particular cancer. Less than 5% of those are recommended for screening undergo endoscopy and we now have an opportunity with this test to improve that number and to potentially save lives. The test is recommended in major professional society for 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 could see here in the blue, the EsoGuard results for cancer, pre-cancer and early stage pre-cancer, very competitive to other comparable early infection tests, whether it be Cologuard, 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 pre-cancer phase, which, as I mentioned, is necessary to have an impact in this disease. You could see that our overall pre-cancer defection rate is nearly 90%, which is again unprecedented and substantially better than other early detection tests. And if you move earlier on to the early pre-cancer stages, we continue to maintain excellent detection of those levels and other screening tests really have no ability to detect this early pre-cancer. These results are really critical for our ability to detect early pre-cancer to have an impact on esophageal cancer deaths. The EsoGuard commercial opportunity is quite large. There are at least 30 million patients who buy existing professional society guidelines or at-risk chronic heartburn patients were recommended for pre-cancer screening. Medicare has established a payment rate of $1,938 and that rate has held up in pricing and payments from commercial payers. That leads to a very large multibillion dollar 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. This is our eighth consecutive quarter of meaningful quarter-on-quarter growth in two consecutive years. We performed 2,575 tests in the third quarter, which is a 17% increase from the prior quarter and a 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 and mid throttle approach, which is exactly what we're doing here. We're trying to drive test volume to support claims history and clinical utility. And 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 for testing and the operator. We continue to have about a 2:1 ratio between referrals from primary care physicians and referrals from specialists or institutions. 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 to 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 really expanded our geographic reach and our ability to be front and center with physician practices. Our Check Your Food Tube pre-cancer detection events, which we started earlier this year continued to grow. We've had dozens of events. We are expanding beyond firefighters. It's been our first event with policeman. 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. Another important update is that we're transitioning to use our long time telehealth partner, UpScript, as the physician prescriber for all events, which will greatly enhance the efficiency of these testing events and the processing of these patients. As I mentioned, we are making a major push into direct contracting. It's an area -- it's been an area of focus for us for a couple of quarters. We've had our first contracted employer Ancira, which we've announced and the testing at multiple sites for that 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 from him. As I've mentioned on prior calls, we've been pushing harder on strategic accounts. These have longer lead times would have the opportunity for significant yield. And we are gaining traction with health systems with academic medical centers. We have active testing now at the Avita Health Center in Florida, Northwestern Medicine in Chicago and even at Mayo, Scottsdale. We've been pushing quite hard, as we've talked about on prior calls on market access. So market access, just to remind folks, really has two pillars. One is revenue cycle management, which is the process of claims submission, adjudication, 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 and 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's 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 to provide coverage for the EsoGuard test, so we can continue to convert test volume growth into revenue. So a few more details on this. On the revenue cycle management side, we announced last quarter that we had transitioned to and upgraded our revenue cycle manager to Quadax, 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's 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 rate. So we're really excited about that. And that's -- we've 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. As I mentioned also our new VP of Market Access is now actively engaged with multiple commercial payers, and we're pursuing multiple pathways to commercial coverage. 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 two. 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 is something that we're actively engaged with. To hear a few more details on our clinical utility studies that we've announced. We have four studies, one of them retrospect, three of them prospective that we've previously reported on. The San Antonio Firefighter study has been accepted for publication with 385 patients. 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 increased 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 -- are the PREVENT registry and the subset of that, which is to prevent firefighter registry is a prospective multicenter 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 in 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 1,500 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 AFB study, which is a prospective virtual patient randomized controlled study is still recruiting. We're at just under 80 patients and looking for a couple of 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 three studies where we've released data has been outstanding with really near perfect results and near perfect concordance, but that means this is the critical thing from a payer 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 one or two patients who were referred for indications other than screening for pre-cancer. 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 of 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 two 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 has a significant -- which can significantly improve the performance of the assay near its cutoffs. That -- the analytic validation studies or AV studies that were used to get this to launch. That data is being presented at this week's Association of Molecular Pathology Annual Meeting 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 EsoGuard 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 have -- will allow us to have significantly lower per sample sequencing costs. Also, as we announced, we're having -- very excited, we're holding an Investor Day in New York City on December 13th from 10:00 a.m. to 2:00 p.m. where we and other key opinion leaders and other experts will be providing really an in-depth educational event on all things, Lucid all things EsoGuard, and further details of this will be provided on our investor website when they're available. With that, I'd like to pass the baton off to Dennis, who will provide us with our financial update.