Lucid (NASDAQ:LCID)诊断公司(LUCD)公布其2024年第一季度收入大幅增长，同比增长124%。在财报电话会议上，该公司讨论了其财务业绩、业务战略和里程碑，包括美国国家癌症研究所(National Cancer institute)赞助的EsoGuard食管癌前检测临床验证研究的积极数据。尽管在索赔和支付范围方面存在挑战，但Lucid Diagnostics对其市场潜力和EsoGuard测试的影响表示乐观。
Lucid Diagnostics报告收入超过100万美元，同比增长124%。
测试量保持在2420次，比上一季度增长10%。
该公司通过2,980万美元的优先股融资加强了资产负债表。
联合国的积极成果重点介绍了美国癌症研究所对EsoGuard的研究。
商业执行方面的努力包括建立伙伴关系和精简远程保健业务。
Lucid Diagnostics正致力于确保医疗政策覆盖范围和直接合作为保证收入而收缩。
尽管收入周期管理有所改善，但索赔和支付范围方面的挑战仍然存在。
Lucid Diagnostics计划通过直接合作将EsoGuard扩大为承保范围ntracting倡议。
o正在进行的谈判合同和固定价格测试日到位，以确保收入。
该公司的现金余额为2480万美元融资1160万美元。
该公司在索赔和支付范围方面面临挑战，这可能会影响未来的融资。
未决款项和上诉程序的积压正在增加，但时间仍不确定。
在使用其EsoCheck产品进行的10,000多次测试中，Lucid Diagnostics没有遇到任何设备故障。
大约一半的裁决索赔稳定在略低于医疗保险费率。
这家公司不是监测报销范围，关注有生物标志物立法的州。
收入增长缓慢，这是由于分期收款所致。
该公司经历了一个挫折与FDA召回食道II类设备由于脱落。
Lucid Diagnostics在区域方面取得了进展Nal计划和有生物标志物立法的州。
有限公司对escheck设备的优越性和民族性充满信心所有的意识预计将增长到一旦覆盖率触发器得到满足。
CMS预提交的时间是不确定的，但数据的质量是一个强大的点。
能得到尽管美国以外的实体对此感兴趣，但目前尚无扩张计划。
Lucid Diagnostics继续专注于其核心市场，并对其EsoGuard测试的潜在增长和影响持乐观态度。该公司的战略举措和合作伙伴关系旨在确保稳定的收入流，尽管存在挑战。随着公司的发展，建议投资者继续关注未来的更新和里程碑。
截至2023年第一季度，Lucid Diagnostics Inc. (LUCD)在过去12个月的收入增长超过544%，这表明该公司有能力大幅增加其销售额。这与文章中提到的2024年第一季度收入同比增长124%相吻合。InvestingPro提示之一指出，分析师预计今年的销售额将增长，这支持了该公司提出的积极前景。
然而，对于投资者来说，重要的是要考虑公司的财务健康状况，而不是收入数据。据报道，Lucid Diagnostics正在迅速烧钱，这是InvestingPro提出的另一个关键点。这些信息是至关重要的，因为它提供了对公司可持续性的洞察，以及文章中讨论的有效索赔和支付覆盖策略的紧迫性。
该公司的市值为4702万美元，尽管收入增长令人印象深刻，但Lucid Diagnostics尚未实现盈利，市盈率为-0.94。此外，该股在上周经历了大幅波动，但在过去一个月也显示出强劲的回报，这表明关注短期表现的投资者可能会反弹。
想要更全面了解Lucid Diagnostics财务状况和未来前景的投资者可以在http://k1.fpubli.cc/file/upload/202405/14/ic1kete3xpb上找到更多的InvestingPro提示。这里有11个建议，提供了更深入的见解，可能是做出明智投资决策的关键。要获得一年或两年一次的Pro和Pro+订阅额外10%的折扣，请使用优惠券代码PRONEWS24。
接线员:早上好，欢迎参加Lucid Diagnostics 2024年第一季度业务更新电话会议。此时，所有线路都处于仅监听模式。报告之后，我们将进行问答环节。[操作说明]请注意此事件正在被记录。现在我想把会议交给Matt Riley, Lucid Diagnostics的投资者关系总监。请继续。
马特·莱利:谢谢接线员，大家早上好。感谢您参加今天的商业更新电话。今天和我一起参加电话会议的是Lucid Diagnostics董事长兼首席执行官Lishan Aklog博士和Lucid Diagnostics首席财务官Dennis McGrath。宣布我们的业务更新和财务结果的新闻稿可在我们的Lucid网站上获得。请花点时间阅读新闻稿中有关前瞻性陈述的免责声明。业务更新、新闻稿和电话会议包括前瞻性陈述，这些前瞻性陈述受已知和未知风险和不确定性的影响，可能导致实际结果与所作陈述存在重大差异。可能导致实际结果不同的因素在免责声明和我们提交给证券交易委员会的文件中有所描述。有关这些和其他可能影响未来运营的重要风险因素和不确定性的列表和描述，请参见Lucid向美国证券交易委员会提交的最新10-Q表格年度报告以及10-Q表格季度报告和8-K表格中提交的任何后续更新中的第一部分1A项“风险因素”。除法律要求外，Lucid不承担任何意图或义务，公开更新或修改任何前瞻性陈述，以反映变化和预期，或反映预期可能基于的事件、条件或情况，或可能影响实际结果与前瞻性陈述中所含内容不同的可能性。下面有请Lucid Diagnostics的董事长兼首席执行官，Lishan Aklog博士。丽山，把它拿走。
Lishan Aklog: Thank you, Matt, and good afternoon, everyone. Thank you for joining our quarterly update call today. I also like to thank our long-term shareholders for your ongoing support and commitment. Our team here at Lucid is singularly focused on driving our enterprise towards what we believe is a massive commercial potential and to enhance our long-term shareholder value. Very pleased with the excellent progress the team has made over on multiple fronts during the first quarter and the start of this year and really look forward to very exciting very near-term milestones for our business. In particular, really excited about the fact that we're able to strengthen our balance sheet, closing out our $30 million preferred stock financing to long-term investors that extends our runway well past these near-term milestones and keep stock out of the market even further into the future. Let's start off as usual with some highlights. First, with regard to our commercial execution, we collected approximately just over $1 million in revenue for this quarter, which is flat quarter-on-quarter and about 124% increase on an annual basis. As we had noted last call, our first quarter test volume remained also in approximately the same range, about a 10% increase at 2,420 tests, that's also a 31% increase on an annualized basis. We do still see increased productivity from a seller point of view improving. CYFT events are thriving. We had 32 such high-volume health fair events and we have now implemented a very streamlined centralized telehealth operation as part of it. We're very much focused and engaged on our robust pipeline of direct contracting engagements, as we'll talk in more detail later, that involve benefits brokers, third-party administrators and self-assured entities offering EsoGuard as a covered benefit. Our efforts over the past six to nine months with revenue cycle management improvements continue to pay dividends. We continue to work on a variety of initiatives to improve this process further, including prior authorization, appeals, physician advocacy and others, while maintaining stable out-of-network allowed amounts averaging about $1800. Some key strategic accomplishments for the quarter include, as I mentioned, strengthening our balance sheet by completing a $29.8 million Series B preferred stock offering. Very key landmark accomplishment from this quarter was the peer reviewed publication of positive data from a landmark National Cancer Institute sponsored clinical validation study of EsoGuard esophageal pre-cancer testing that demonstrated unprecedented early pre-cancer detection. We'll cover those details a little bit later. This study strengthened EsoGuard's clinical data supporting ongoing engagement to secure both commercial and medicare payer coverage. We've now secured a date, July 17, for our MolDX pre-submission meeting, which will be our opportunity to review data, with the MolDX group for a technical assessment seeking coverage of EsoGuard under its foundational local coverage determination for medicare coverage. We are actively executing on what's an aggressive market access strategy that's focused on securing medical policy coverage with regional plans and biomarker legislation states, we'll cover that in some more detail later and as well as pilots with national plans. For those who are new with the story, just a few slides to tell you about Lucid. Lucid Diagnostics is a commercial stage cancer prevention medical diagnostics company. We're focused on early pre-cancer detection, and our goal is to prevent esophageal cancer deaths in at risk patients. And we have two technologies, our EsoGuard esophageal DNA test and EsoCheck cell collection device. The EsoGuard test is 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. As I said previously, and I'll say it again, the performance of this test is really unprecedented for a molecular diagnostic test. That statement is highlighted here in a comparison of EsoGuard's performance to some other sample tests in the colorectal cancer screening space, Cologuard, which is widely successful and widely available and has been for many years and liquid biopsy tests from Guardant that has published data recently and has got a lot of attention. It's important when you understand the performance of these types of tests to document it in a variety of different categories. When it comes to cancer, you don't want to miss cancer and we have very similar, if not superior sensitivity for detecting esophageal cancer at or above Cologuard and other such tests, and certainly superior to the blood test like Guardant. But the real differentiation, the reason why I comfortably use the term unprecedented is when you talk about pre-cancer. Remember, that's what we're focused on and what we need to accomplish. In the pre-cancer stage, we're still at that 90% plus or minus, very close to 90% sensitivity rate and that's just unprecedented. Cologuard does a pretty good job at picking up late-stage pre-cancers, but that percentage sensitivity is about 40% to 50%. The blood tests are just not really in the end of the cohort, when it comes to that. Even more impressive is that, we're not just picking up late-stage pre-cancers, but we're picking up early pre-cancers and that is truly unprecedented. Similar sensitivities for that early pre-cancer, those early pre-cancer numbers and there's no ability in these other tests to pick up the earliest stage pre-cancer, which gives us the opportunity to have a real impact on these patients. Even within that early pre-cancer stage, we have sensitivity still maintained even if you only have a short segment of disease, which is actually the most common presentation of these patients that we're trying to pick up and the most common scenario that leads to cancer and that's at 89%. False negative rates, false positive rates are all really in the excellent range for tests of this kind. This results in a very large market opportunity for Lucid. There are 30 million patients, actually more than 30 million patients that are at risk and are recommended for testing for pre-cancer testing by the professional society guidelines. Medicare has established a mark for payment for this test at $1,938 and as I've said, we will show further that price point has been holding up quite well with out-of-network payments. That translates into an approximately $50 billion total addressable market opportunity. We have a lot of opportunity even with low levels of penetration to generate substantial revenue. Our gross margin, at our current volumes is approximately 90%, which also facilitates our ability to derive this business. We have developed over the years a multi-pronged commercial strategy, which is focused on getting patients access to this test in a variety of settings. We have our own physical test centers in about 13 cities. Our primary approach to testing is our satellite Lucid test center model, which partners with physician practices, primarily primary care physicians where our clinicians will schedule days in their office to test scheduled patients, 10, 15, 20, even 30 patients in a day. That's the dominant form of our testing right now. We also partner with physician practices, especially specialty practices for us to work with them and their personnel to do testing in their office, and that model extends to smaller hospitals as well as larger integrated delivery networks. We have a mobile Lucid test center that serves us well in the State of Florida, where that's necessary to do this kind of testing. A big part of our activity -- commercial activity remains for CYFT or CheckYourFoodTube health care type events focusing primarily on firefighters, but expanding to other targets as well. Let's talk a little bit about how this quarter went. Our test volume has remained flat approximately, as we mentioned, 2,420 test for the first quarter. That's consistent with what we described last quarter, where we have frozen our sales team actually going back to the early part of 2023. Although we are extracting some increases in productivity, we have some unfilled positions and have transferred some of those resources into market access and direct contracting. And so this is where we expect to be until we reach points with regard to realization of revenue that justify us increasing our sales team and driving our test volume, which we're confident we can do at the appropriate time. Revenue, again, was flat quarter-to-quarter. Dennis will be talking a bit more about those trajectories and the realization of revenue as a function of test volume and revenue opportunity. On the commercial execution side, we've had, as I said, our protected FoodTube events are thriving. We held 32 such events during the first quarter. We've implemented a really streamlined, centralized telehealth operation where people, for example, as -- for testing on a fire department they can prior to -- prior to the day of the event can actually register through our telehealth operation and get there, telehealth visit with the physician, confirm that they qualify for the test and actually have that referral made all prior to them arriving. Our engagement with the firefighter community is just very -- strengthening every quarter and is very powerful and very gratifying. Our team attended the FDIC International conference, the largest -- the leading firefighter conference in the country and we’re in Indianapolis with 30,000 firefighters. We did on-site EsoGuard testing and engaged with fire chiefs from all around the country. Another major push as I hinted at remains our direct contracting initiative. We have a robust pipeline of direct contracting engagements with benefit brokers, third-party administrators and self-insurance entities. And how does this work in this pathway, we are offering EsoGuard as a covered benefit to drive contractually guaranteed revenues. We've targeted these three groups, benefit brokers, third-party administrators and such, self-insured entities such as employees and unions and other partners where there are large groups of patients such as 9/11 Funds and others where there's an opportunity to access and then contract directly with these entities that cover these patients. And there are a variety of ways that we're engaging with these entities with some we’re negotiating direct ongoing contracts or just where we charge on a per patient basis, those that -- where we enter through a benefit plan, we can charge for a lifetime benefit per member. And then we also offer testing days either full or half testing days at a fixed price. So we're really looking forward to ramping this up during the second half of the year and feel we have the opportunity to do so as a supplement to the traditional pathways. So an update on our overall experience with claims and payment and coverage. Revenue cycle management remains critical. We continue to have ongoing improvements in our process in partnership with Quadax our RCM provider. These improvements include -- we're going to start a prior authorization program, which accounts for approximately 1/4 of the denials and we're hoping to eliminate those through prior authorization. Our appeals process is getting much more sophisticated and targeted and when our -- the percentage of appeals that we win is improving steadily. We're recruiting and this is actually gratifying. We're including physicians, local physicians to advocate on our behalf with regard to local payers, which is something that could have a big impact. Dennis will talk about the numbers a little bit more detail, but we continue to have about half of our adjudicated claims allowed by the payers. This is all out of network and the payment is remaining stable at just under the Medicare rate. Some big developments on the medical policy and coverage side, particularly with Multi X upon publication of the National Cancer Institute-sponsored study. And the outstanding results from that we pulled the trigger and asked for and secured a meeting with the Multi X group that's scheduled for July 17. This is a pre-submission meeting, where we get an opportunity to discuss the body of clinical evidence. These are categorized as clinical validity data, clinical utility data, analytical validity data and review that data with them, get their feedback and proceed thereafter to submit what's called a technical assessment, or TA that seeks coverage under the existing foundational local coverage and termination, or LCD that MolDX and other Medicare contractors published last year for tests in this category of the esophageal testing. On the private side, we are, again, actively executing on this strategy. We're focused on securing medical policy -- positive medical policy coverage with regional plans and have engagements with a number of them and a high area of focus for us are biomarker legislation states, which I'll show -- talk about a little bit more as well as pilot plans with -- pilots with the national plans where we see coverage with evidence development, where we are able to demonstrate the clinical utility of our study to that particular payer as well as the potential economic benefits to that payer in a study while getting covered and paid over that time. So those are the things that we continue to actively pursue. The biomarker initiatives are really, we think, will have a big impact. There are multiple states now that you can see here that it passed biomarker legislation that effectively mandates by statute that they're different from state to state, but effectively mandate that local payers cover these kinds of tests and ours -- and we're going state by state and working with the local -- with each state to confirm that we are covered under these -- under this legislation and use that to seek coverage at a minimum coverage under the biomarker legislation for individual payers. So it gives us a great opportunity to do that. I'm going to provide a brief overview. We had a press release about this. The results of this exciting, what I believe is a landmark study from a National Cancer Institute sponsored a group called BETRNet consortium sponsored by the NCI and they published a landmark paper weeks ago in the American Journal of Gastroenterology on EsoGuard performed on samples collected with EsoCheck compared to upper endoscopy, and its performance in detecting esophageal pre-cancer and cancer plan and the conditions along that spectrum. The highlights are impressive and again unprecedented. The sensitivity for cancer was 100%. All of the cancers were detected. The overall sensitivity and specificity was 85% each, a very, very key number that we believe is critical to demonstrating the value of this test is something called the SSBE or short segment BE sensitivity. That's your ability to detect the short segment, less than 3 centimeters, 1 to 3 centimeters of disease. That's the hardest thing to detect because it's just a small patch of disease and down by the far end of the esophagus, and it's the one that's most challenging for any type of molecular test. The key -- the reason why this is important is that about 70% of the cases we're trying to identify in the screening population as defined by guidelines are short segments. So, if you can't detect -- sorry, and they account for about half of the cancers. So if you can't detect short segment BE, with high level of sensitivity, then you're not going to have the ability to have an impact on cancer death because that's where most of this disease is. And we're hitting that at a really high rate of 89% rate and a negative predictive value, so a really low false negative rate, NPV of 98%. They documented something that we continue to see, which is the average procedure time of 2.5 minutes. That's an average. We're seeing times less than that. Some of us in the office had -- were tested last month and it took 30 seconds for the test to be completed. So really outstanding and particularly in comparison to potential alternatives, it's a critical part and you believe in having a highly efficient screen test. We have the study has shown no adverse consequence of adverse events from the testing, consistent with other studies that we've shown to date. I'd also like to spend 1 minute or 2 reviewing the results of a paper that was published last month on the technology from an academic institution on a test that's been called [encoga esophagus]. The group used a sponge on a string device called EsophaCap to sample cells from the lower esophagus and apply a new molecular test with methylation marketers audit. I'll note that the EsophaCap device is a device that we acquired and supplied for a portion of the study, although we no longer supply that. Some highlights to note, particularly in contrast, are that the test showed poor sensitivity for short segment BE, which as I mentioned last time is really the most critical number in having an effective screening test for esophageal pre-cancer at 63%. There were also some troubling complications, about 20% had mild abrasions of esophagus, but 2% had serious abrasions, with bleeding, and there were two catastrophic device failures in the form of detachments. I thought it was worth summarizing a head-to-head comparison of our results. These are pulled results, although they're pretty consistent across the various studies as EsoGuard and EsoCheck with the results that were reported in this publication on the oncoGuard test in combination with a sponge in the string test. So again, let me emphasize the importance of short segment BE as critical because these are the patients that account for about half of the cancers, a 63% sensitivity in that category. It just -- is not going to be sufficient to serve as a commercial test. And again, that data is from this publication that was published last year. Also note that, that level -- that 60% -- approximately 60% sensitivity in this critical category is about the same as the sensitivity that was published in the paper on that used the Medtronic (NYSE:MDT) Cytosponge another sponge on strings, old technology sponge on strings that led Medtronic to withdraw that technology from the market. A variety of ways that -- a variety of areas to contrast. If you look at the device effectiveness, as I noted, EsoCheck gives you anatomic targeting of the area, just a very small area where this abnormality occurs, sponge on string devices developed. EsoGuard -- EsoCheck provides protected sampling. So there's no dilution and no contamination from cells elsewhere, only in the area where the targeted area, sponge on string devices do not. Lots of issues with regard to procedural efficiencies, the paper showed that the SOS device required a topical anesthesia, essentially numbing medicine applied to the mouth. EsoCheck does not require that. The SOS devices have to sit in the stomach and desolve for 8 minutes, again, as reporting the study, there is no dwell time. EsoCheck does not require that. They had two devices that failed to deploy, and they didn't dissolve. They pulled them out and they were still not fully deployed. But we don't have that issue at all with EsoCheck. If you take the 8 minutes and time to swallow them back, the time to actually complete the procedure is about 15 minutes, as I mentioned, we're doing them in 1 minute to 2 minutes or less, a little as 30 seconds. That's really important if you're doing these large events like one of these CheckYourFoodTube events. We've done 100 -- we've tested 100 patients in a day at a firehouse. You can't do that if it takes 15 minutes or more per patient. And the only reason we can do that is because of the -- these low procedure times. The technical failing rate or sort of being able to complete the test without patients being able to swallow and get a sample, our numbers and data that was presented at a big GI conference on 1,500 patients was 98%, which is a 2% technical failure, much higher in the sponge on string devices. But the key area here and one that I think is going to be ultimately the message here is on device safety. There were two detachments that are serious, if not catastrophic. The sponge attached from the string. In one case, it had to be retreated endoscopically and another pass through the intestine, but with the -- putting the patient at risk of a serious obstruction and serious health risk. As a result of these detachments, we actually initiated the recall of the space device that was used in the study after notifying the FDA about this. And that was something that was mandatory. So that's going to be a significant issue that we just don't have to address. We've never had any device failures for EsoCheck in now over 10,000 tests. And the abrasions in the series abrasions are not surprising, but significant contrast here. These sponge on devices are literally like a sponge like brillo pad that scrapes the esophagus. So it's not surprising that you would see patients who have these abrasions, including 2% that have a serious abrasion. EsoCheck is a balloon that has a soft sort of cushion surface to it with soft ridges on it, and we just simply don't see these issues with EsoCheck. So with that, I'm going to pass the baton on to Dennis to talk about our financial results.
Dennis McGrath: Thanks, Lishan and good morning, everyone. Summary financial results for the first quarter we reported in our press release that was published earlier today. On the next three slides, I'll emphasize a few key financial highlights from the quarter. But I encourage you to consider those remarks in the context of full disclosures covered in our quarterly report on Form 10-Q. Balance sheet cash at quarter end March 31 was $24.8 million. We added $11.6 million to that amount with the financing completed last week for a pro-forma cash of $36.4 million. The average quarterly burn for the trailing four quarters is $9.5 million per quarter. The burn in the first quarter included $7 million from ongoing operations and $2.5 million from the quarterly management services agreement with a PAVmed (NASDAQ:PAVM). Additionally, the company paid down the intercompany debt to PAVmed with PAVmed accepting 3.3 million shares for a $4.8 million debt reduction as previously disclosed in connection with the dividend distributed by PAVmed to the PAVmed shareholders of Lucid stock plus $2.8 million in cash payments. We disclosed in the 10-Q that our ability to fund operations beyond one year from today is largely dependent upon how revenues ramp over the next four quarters, which is, of course, dependent on how the reimbursement landscape for both government and private health insurance continues to improve. Additionally, our direct contracting efforts with self-insured employers and/or corporate finance activities, including refinancing the outstanding debt at that time can also work to exceed that threshold. Beyond that, there is nothing substantively remarkable about the remainder of the March 31 balance sheet, shares outstanding, including unvested restricted stock awards as of last week are 52.2 million shares, which includes $1.1 million issued subsequent to quarter end in connection with conversion notices received from a convertible debt holder. The GAAP shares outstanding as of March 31 of 46.7 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested restricted stock awards. On Slide 20, it compares this year's first quarter to last year's first quarter in certain key items, plus your review of the information in my comments in light of the cautionary disclosure on the bottom of the slide about supplemental information, particularly non-GAAP information, I'm required to say that. As previewed in our fourth quarter earnings call, revenue of just over $1 million for the first quarter sequentially about even with the fourth quarter reflects more than a two-fold increase over the prior year first quarter. The amount reflects actual cash collections for the quarter, plus a small amount of invoice EsoGuard tests delivered to the VA, plus about $25,000 for direct contracting. Test volume at 2,420 tests for the quarter, represent just over $6 million in submitted claims at our $2,499 ASP. Revenue recognition and I know this gets repeated each quarter, but it's important key determinant is the probability of collection. And therefore, due to the fact that we are in early stages of our reimbursement process means revenue recognition for claims submitted to traditional government or private health insurers will be recognized when the claim is actually collected versus when the patient report is invoiced and submit it for reimbursement. As you'll see and disclosed in our 10-Q, this is called variable consideration of the jargon of GAAP's ASC 606 revenue recognition guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring physician. For billable amounts contracted directly with employers and that are fixed and determinable, they will be recognized as revenue when the contracted service delivered. That means -- generally means when the report is delivered to the referring physician. Our non-GAAP loss for the first quarter of $9.4 million, reflects about a $500,000 sequential improvement compared to the fourth quarter loss and about a $400,000 improvement year-over-year from the prior year first quarter. Slide 21 is a graphic illustration of our operating expenses for the periods reflected. Total non-GAAP OpEx is $10.4 million for the first quarter of '24, reflects about a $500,000 decrease sequentially and is fairly flat year-over-year. Cost of revenue primarily consists of EsoCheck devices, lab supplies and fixed lab facility costs, and it is in line with the last couple of quarters where the test volume has ranged between 2,200 and 2,600 tests. The non-GAAP net loss per share has been relatively flat for each of the last five quarters, plus or minus $0.01 between each of those five quarters. On a GAAP EPS basis, non-cash charges accounted for approximately $0.19 per share in the first quarter of which $0.17 was directly related to the non-cash deemed dividend connected to the March financing of $18.2 million. A couple of reimbursement highlights. Focus on the last two quarters with our first quarter of this year and the last quarter of last year. Collectively, there were just under 4,000 claims, 3,975 claims, representing just under $10 million in pro-forma revenue that were submitted for reimbursement. about 75% have been adjudicated, 25% are pending. Out of the 75% that been adjudicated about 46%, almost half resulted in an allowable amount by the insurance company with a mean average of about $1,700 per test. And as you collect these things over a longer period of time with a longer aging time horizon with appeals, approximately $1,800 per test, which is in line with previous quarters, we report the same statistic. Of those denied, about 53% of the denials are deemed not medically necessary or require a prior authorization and about 28% were deemed to be non-covered. So with that, operator, let's open it up for questions.
接线员:[接线员说明]您的第一个问题来自Needham公司的Mike Matson(纽约证券交易所代码:MATX)。
Michael Matson:我想从DX提交前的小型会议开始。你能不能告诉我们更多关于你对会谈的期待以及会谈的潜在结果?
Lishan Aklog:澄清一下，这些是提交前会议。我认为这个类比适用于那些经历过或听说过FDA提交前会议描述的人。虽然不是很正式，但是很相似。这些会议的目的是与关键人员，Multi X的医疗主管会面并审查完整的证据基础包括临床有效性，临床效用和分析有效性数据并在已经出版和最终确定的基础LCD元素的背景下这样做简单地在新信息的背景下进行对话，例如指南等等。因此，我们希望能够很好地代表我们自己和其他人，他们可以在结果中描述我们的数据背景。这样做的目的是能够告知实际的文件，技术评估将在会议之后提交，以正式寻求基本LCD的覆盖范围。除了公司各种关键职位的人员外，我们预计还有其他关键专家Stan Lapidus，我们的副董事长，专家和诊断将做出贡献，以及我们的一位医学顾问，他是专家和指南的作者，我们希望提供一些额外的支持。这就是这次会议的性质。我们会带着我们对他们的数据所处的位置的感觉离开，并告知实际的正式流程，即提交技术评估，并在会议之后开始计时——在提交之后，不好意思。
Michael Matson:接下来，你们每个季度都有2500到2400个测试，这已经持续了几个季度了。我想，你们的收入也在增长，因为你们有能力收取更多的付款。那么我们预计你会保持这种等待状态多久呢?你什么时候开始尝试扩大测试——在你开始真正推动更多测试量之前，你需要在覆盖率或付费率方面达到什么水平?
Lishan Aklog:我想谈谈测试量方面的问题，我想谈谈翻译测试的收益。因此，我们在上次电话会议上谈到了这一点，我们在销售方面有固定水平的人员，很明显，我们一直保持着一种态势，我们试图在一段时间内尽我们所能保持运营成本持平。正如我上次提到的，但我要重申，索赔——我们的测试量已经足以推动索赔历史并推动我们与私人支付者的接触。再次重申一下我们上次所说的，这个水平，大概在2400人以上的范围内，我们认为我们目前的团队可以维持这个水平。本季度，我们在该领域的卖家确实减少了，因为我们运输了一些资源，并且没有填补某些空缺职位，以确保我们在关键市场准入和直接合同计划的相同总体运营成本下拥有足够的资源。因此，当然，即使在目前的水平上，我们也有可能继续看到一些温和的增长。由于CheckYourFoodTube活动的增加，我们看到季度环比增长了10%，这在每次测试的现场销售人员方面往往更有效。很明显，如果我们开始看到一些——当我们开始看到一些在直接签约方面的牵引力，这可以推动测试量独立于——基本上独立于销售活动。所以我要让Dennis谈谈我们的门槛在哪里，在我们收入的哪个点上——收入和收入的实现来自测试量，我们是否会考虑增加我们的运营成本，增加一些资源，以推动测试量作为一种驱动方法——作为推动收入的杠杆。
丹尼斯·麦格拉思:迈克，我认为这些决定将以季度为基础，因为我们看到了实现，这意味着现金收款占可支付索赔的百分比会增加。正如立山所指出的，有一些影响因素会影响我们在开始做出投资决定的时候，一些事件开始显现出来，甚至可能在实际收藏之前。他们是直接合同，因为价格是有保证的，我们看到价格开始上涨，这给了我们理由。事实上，我们已经在这方面投入了额外的资源。此外，我想我们之前提到过，我们已经向一些较大的区域保险公司提交了一些正式申请，当这些决定可用时，它们将从网络外转移到网络内，这将影响到这些投资。很明显，这预示着在获得批准后的几个季度里，实现目标的情况将会怎样。显然，为了应对即将到来的医疗保险决定，这也会影响时间。我们也在努力全面了解生物标志物立法，以及它可能产生的影响——这两个州都要求保险公司在其州内运营，这是如何发挥作用的。我们与之保持相当密切的协调，因为我们在这些州投入额外的资源是否有意义，因为他们在州立法和覆盖生物标志物的实际载体之间制定了这些物流。这些都是促使我们加速前进的因素。显然，有了最近的融资，我们就有能力对这些事件作出反应。所以请继续关注。正如我一开始所指出的，这是一个季度一个季度的基础。我们已经准备好将这些措施落实到位，以应对这些事件。
接线员:您的下一个问题来自马克西姆集团的安东尼·文代蒂。
安东尼·万代蒂:其中一些问题是围绕着我的，但也许只是进一步谈谈这个过程。你提到你希望医保覆盖范围能从网络外扩展到网络内，这显然是很重要的。你能不能提醒一下我们现在有多少保险公司会报销——也许是大型保险公司的数量，比如信诺，安泰，联合医疗公司。他们的报销范围在哪里?他们在今年或未来12个月内注册网络内或网络外的可能性有多大?
Lishan Aklog:是的。让我在高层次上概述一下。你问的是那些大买家。澄清一下，在网络外，我们是有报酬的。我们有——我们有——我们有网络外的报酬，然后通过这些数字。我们确实得到了允许的索赔，而且允许的索赔仅低于医疗保险的平均费率。其中一些大的支付者实际上是作为一个分布来做的，其中一些是以更高的速度做的。我们关注的是近期医疗政策的变化，或者积极的医疗政策的覆盖范围，而不是集中在大的付款人身上。我们与大支付者的接触主要集中在寻求证据开发覆盖的试点上，因为我们的理解是，大支付者通常会等待Multi X和医疗保险的积极覆盖。然而，我们正在积极推进区域规划，这是一块非常肥沃的土地。上次我们提到，我们与蓝十字盾协会合作，这是一个帮助我们的全国性协会，他们在我们与各州计划的合作中表现得非常出色。实际上，我们正在减少这些，我们已经取得了一些成功。正如丹尼斯所提到的，特别是那些有生物标志物立法的州，我们真的相信我们可以在短期内独立于MolDX过程，在这些地区计划下取得进展和覆盖。当然，还有这些直接合同，它们完全独立于整个支付过程。其中一个例子是我在右边展示的这张幻灯片中，有一些实体他们有大量的病人，他们支付他们的费用，用于保险条件其中一个我们已经预览过的是世界贸易中心9/11基金。我们与他们进行了积极的讨论，我们乐观地认为，我们能够通过他们的一个卓越中心与他们进行最终接触，我们现在正在与之交谈。所以这是一条为患者提供的途径，他们被覆盖在其中大约有10万名患者可以参加我们的测试，作为一种覆盖的福利，而不完全独立于保险公司的付款过程。
Michael Matson:也许这里有更大的图景。您和几位胃肠病学家以及一位思想领袖度过了一个很棒的投资者日，他们谈到PAP如何改变了外科癌症，很明显，还有Cologuard，当您看到这个过程继续展开时，您的一些竞争对手正在召回产品，是否存在一个临界点?你认为在EsoGuard或EsoCheck成为标准并变得更加知名之前，还需要3到5年的时间吗?因为就在那时，我和来宾们交谈——其中一位胃肠病学家参加了这个投资者会议。他只是说，很难让大家知道因为并不是每个人都认为食管癌是一种主要的癌症尽管我们知道它是最致命的癌症之一。你认为这个过程需要多长时间才能达到临界点?我很好奇你对此有何看法?
Lishan Aklog:让我从后一部分开始。所以这并不难因为人们对食管癌的关注越来越多。你是对的，在过去的几十年里，我们关注的是乳腺癌，结肠癌，前列腺癌和一些常见的癌症。但是我们的努力和能力让这个信息传播出去并让它在医生群体中产生共鸣，不管是初级保健还是专家都是直截了当的因为我们有一个直截了当的故事。我们有明确的目标人群。我们有一个——我们有一个方法和对生物学的理解。我们知道如何处理阳性的病人。因此，你从医生那里听到的信息，例如，在投资者日，正在全国范围内引起共鸣。这实际上在全国各地的新闻媒体上都有报道，消防员事件对我们很有帮助。我们在洛杉矶的ABC新闻上做了一篇很棒的报道，我们有很多这样的事情正在发生，我们希望这个渠道能转化为全国的意识。这是一个过程，但我认为这个过程不会花费数年时间，因为所有的部分都已到位。我们不需要定义总体。我们不需要制作所有的元素来讲述一个非常吸引人的故事。我可以告诉你，在我做过的每一个晚期人群的采访中，我们最近都是一个NPR。这是一次非常直截了当的谈话，我们实际上——这对我来说非常惊人，我认为这种情况每周发生一次左右，当我们和人们交谈时，他们客观地——只是客观地谈论业务，我们听到一个家庭成员、朋友或同事患了食道癌。医生团体，GI团体，这实际上也很简单因为这已经在他们的指导方针中了。我们没有写他们的指导方针。因此，需要识别癌症前期并将其作为预防癌症的方法，这是公认的。我们没有需要克服的障碍来证明在这种情况下检测癌症前期是一件有争议的事情。在最后三个指导方针中都没有。与Cologuard不同的是，它在一个已经有50%到70%的病人接受结肠镜检查的环境中运作，很少，不到5%，基本上在我们的目标人群中没有病人接受内窥镜检查。因此，我们完全与胃肠病学家结盟，我们有能力与他们交谈，告诉他们走出去，扩大他们的漏斗，识别他们没有看到的病人，增加内窥镜检查的数量和内窥镜检查的产量。因此，我们与GI社区的领导建立了良好的关系，所有的kol——我们真的很兴奋。我们在这个国家每年最大的GI会议，也就是DDW会议上有一个很大的存在，这个会议将于本周末开始。我们的医疗顾问委员会在那里开会，由食道疾病胃肠道领域的知名人士组成，我们将在周五开几个小时的会讨论我之前强调过的所有关键问题，比如短段巴雷特食管的重要性，使用细胞收集设备的重要性但设备安全性较低以及EsoCheck的特点。这个故事是——我们已经把它讲出来了。当我们实际上扩大活动将是我们提到的关于覆盖范围等的触发因素的结果。但这个故事正在传播出去，一旦我们全力以赴，就不会花那么长时间在全国范围内传播。这个故事讲起来并不难，安东尼。
接线员:你的下一个问题来自BTIG的马克·马萨罗。
维云·拜斯:这是维云给马克的电话。很高兴听到预播的日期。你提到了一点，但是提醒我们一下技术评估过程的平均时间是多少我想知道你是否期望最终的CMS覆盖决定?
Lishan Aklog:我们无法预测后者。通常情况下，对GA作出回应的周转时间至少为60至90天，但如果在此过程中出现问题，这部分时间可能会延长。同样，对于那些熟悉FDA流程的人来说，这与数据提交后没有什么不同，一旦TA提交，他们就有机会审查数据。可能会有机会带着关于数据的问题回来。因此，很难说这一过程需要多长时间才能完成并做出最终决定。但我们认为，我们准备好了大量的数据。我们确实有很多顾问在和我们一起工作，他们都是这方面的专家，他们通过Multi X过程做过高级测试，在团队中有相当多的乐观情绪。但就时间而言，这有点难——我说在这一点上已经有可能预测，但我们对数据的实质和质量充满信心。
Vidyun Bais:上个季度，我有一个后续问题，我记得你说过，公司有望获得500万或600万美元的收益。你认为在实现收益方面是否取得了成功?我们应该如何考虑在全年的节奏方面做出贡献?
丹尼斯·麦格拉思:是的，有积压的待裁决金额，从我们的全周期经理的强度来看，上诉程序正在加快。很难预测这一切发生的时间。上诉程序的时间较长。我们在准备好的发言中给出的统计数据显示，大约有25%的案件仍在等待裁决。积压的数量仍大致相同。这种相位很难匹配。但我们知道磁场是什么样的。我们知道我们在那里取得了一些成功，并开始获得一些动力。所以目前还没有额外的颜色可供选择。
接线员:你的下一个问题来自加拿大协议公司的凯尔·米克森。
凯尔·米克森:首先，我想问一些关于食道的问题。首先，让我们回到21年，大概在IPO的时候你收购了CapNostics。你为什么要这么做?什么样的商业协议或生产协议是现在相关的或影响开支的，但不是真正有用的?也许只是告诉我们最新情况。其次，你能否谈谈这里的竞争动态以及某些公司或供应商是如何使用食道的。现在，很明显，这对他们来说不是很好，也许这对你有利。
Lishan Aklog:所以，是的，我们很高兴倒带一段时间，为那些不完全了解历史的人了解一些历史——所以在2021年，我们有机会。我们和一些小公司合作，CapNostics，他们在做海绵串设备。我们得到了它。我们对它很感兴趣，因为它是一种研究工具。我们还在考虑和研究其他潜在的应用。在我们收购它之后，我们与两家正在进行研究的机构进行了讨论，我们同意为这项研究提供资金。我们当时真的不担心这样做。因为我们当时很有信心，EsoCheck是一个非常好的设备，对于这个特殊的应用，我们很清楚海绵在管柱上的局限性。但我们有兴趣将其作为一种潜在的研究工具提供给这些研究没有问题，因为我们非常确定基于之前使用Cytosponge的经验，结果会落在哪里。这种情况一直持续到去年年初。我们并非无法与这两家机构就如何继续供货达成商业协议。所以大约一年前，也就是2023年初，我们停止了海绵的供应。直到最近的一篇文章发表之后，我强调了一下，我们才意识到这两支队伍。我们意识到细胞海绵，另一种海绵在绳子上，这两种技术都已经存在很多年了。EsophaCap本质上与我们收购它的同一家公司在20世纪90年代早期开发的技术相同。我们知道Cytosponge也有许多分支，但EsophaCap没有。正如我们在新闻发布会上提到的，Cytobange目前正在全球召回，特别是针对那些分队。如果你读了我们在新闻发布会上强调的美敦力的语言，它是专门针对与这些分离相关的潜在严重风险的。所以当我们在出版的手稿中看到关于这两个支队的报告时，我们有点惊慌，因为他们没有被报道，他们没有被报告到FDM数据库中。所以我们获得了食品药品管理局的许可，并得出结论，我们必须开始召回这些产品。事情的结果和我们预想的一样，就是科技，电子测试是一回事。但最终，细胞收集设备很重要我在表格中展示的所有头对头的特征对于获得性能水平至关重要特别是短片段的灵敏度和EsoCheck的特性，特别是EsoCheck的收集和保护特性允许目标采样是至关重要的。所以我们对研究的结果并不感到惊讶使用海绵我们补充了一部分，它在那个类别中，特别是，它和美敦力的数据没有什么不同，关于细胞海绵和TTF3的数据是由尼克·沙辛几年前在美国发表的导致美敦力撤回的数据。关于竞争格局，我把整体业务留给你们。我们对细胞收集和分子诊断测试都有极大的信心，公布的数据就是这样。我认为最近的数据确实强调了这样一个事实，如果你想要有一种测试可以有效地检测癌症前期以预防癌症，如果你想要有任何影响，你必须选择癌症前期的短段，因为它们占了大约一半的癌症。所以，在今天结束的时候，我会把它留给你们来看看数据等等。但从我们的角度来看，我们对我们的技术充满信心。
丹尼斯。麦格拉斯:凯尔，重要的是要明白，即使重新设计的努力可以找出如何克服安全问题。这项研究清楚地指出了污染，因为缺乏保护样本的能力。所以他们必须想办法把海绵放回包装纸里，这在物理上是不可能克服的——设计上的限制。所以我们认为，除非有一种方法可以绕过我们在EsoCheck上的专利，否则对于那些拥有优秀生物标志物的人来说，要想让生物标志物发挥类似于我们将EsoCheck和EsoGuard结合在一起的作用，进行取样将是非常困难的。
Lishan Aklog:澄清一下，没有证据证明这一点。我们在这方面有很强的问题和未决的IP。所以我们没有真的是的，我们没有担心没有任何迹象表明有另一种技术不是在20世纪90年代发明的，它可以做那种有针对性的采样，你需要那些非常非常具体的目的，收集细胞在很小一部分的低软用途。
凯尔·米克森:我敢肯定，如果有一天有人会说血液检测在这里是有用的，但我们可以等到另一天再做这个讨论。
Lishan Aklog:我需要很快地谈一下这个问题。所以，是的，我们不会争论血液检测作为一个整体的作用。我把这个留给你们。你你说得对，这方面的报道非常有见地。我们来谈谈食管癌的血液检测，好吗?所以无论目前在检测血液中的癌症方面有多大程度的进展或者实际上有好的数据或者正在取得进展，在检测癌症前期方面几乎没有进展。正如我们之前说过的，除非你在癌前阶段发现它，否则你无法对食管癌的死亡率产生影响因为与结肠癌和其他癌症不同，食管癌的第一阶段诊断仍然有50%的死亡率。而试图检测的生物学，我将展示Guardant是如何做的。巨蟹座的人可以接受癌症。但正如你在报告中强调的那样，即使是在晚期无癌患者中，即使是[看不清的]数据也表明，这个数字甚至更低。所以从生物学上发现异常需要发现早期无癌，为了预防食道癌，你必须这样做，到目前为止还没有任何迹象表明你可以通过血液测试来做到这一点。所以对于我们这个食管癌的小角落来说，我非常有信心在可预见的未来的任何时候，液体活检都不会以任何方式构成威胁。谢谢你让我强调这一点。
凯尔·米克森:最后一个问题是我，你们两个，也许丹尼斯会特别考虑这个模型。本季度的收入为100万美元，与上季度持平，我猜销量是连续增长的，实际上相当不错。我们应该如何考虑这个行业的季节性在其他的筛选行业中，每年的早期都是季节性的，一年到头都会更好。有流感季节，等等。那么，在收入增长的连续增长方面，我们有什么需要考虑的吗?
丹尼斯·麦格拉思:是的，我认为唯一需要考虑的季节性因素是时间——首先，我们的测试管理起来非常方便。所以一年中病人不方便做检测的时候，就是12月的假期。医生是不会安排这个的。圣诞节那周，大检查你的食物频道的活动可能不会发生。他们可能会在那附近。这可能是我们唯一一次看到它。人们考虑的是夏季和8月最后两周的季节性。但九月往往会克服这一点，不管时间段是什么。所以我不认为季节性，特别是当我们处于这种中档范围时，是我们需要考虑的事情。实际上，数量直接与申请索赔的实现以及我们对这种势头的反应有关，我们预计这种势头将在未来几个季度有所回升。
接线员:[接线员说明]我们的下一个问题来自Ascendiant Capital的Ed Woo。
吴宇森:祝贺本季度取得的进展。我知道你们非常关注美国的业务。但是你考虑过国际机会吗?
Lishan Aklog:所以随着时间的推移，我想我们已经讨论过这个问题，有时我们会询问外部的商业实体是否有可能与我们合作。在英国和欧洲，目前围绕筛查测试报销的商业模式并不具有吸引力。所以我们没有做任何特别的努力。但在南美和亚洲也有其他团体联系过我们，这基本上是一种许可类型的协议，我们没有计划，我们认为这与我们目前在其他国家投入资源的战略方法不一致。但那里也有市场机会。当你接到询问时，我们会处理这个案子，我们现在正在积极讨论一个案子。但我不认为这在短期内会起到重要作用。
吴宇森:我有一个小问题。软癌显然是很常见的。我想全球范围内的情况和美国是相似的就三倍的发病率和死亡率而言?
食道癌分为两种类型。我们在美国和西方看到的是食管腺癌。还有食管鳞状细胞癌，在过去，甚至在这个国家，它都是与吸烟和烟草等相关的疾病而不是腺癌，这是与馆长硬品牌相关的。在亚洲，鳞状细胞癌的数量仍然较高，尽管与许多事情一样，世界各地都有某种同质化，因为西方的饮食和生活方式以及与肥胖相关的疾病等等，在世界范围内有很大的机会发生软线癌。希望这能给你们一种感觉。
接线员:现在没有其他问题了。我想把话筒交给Lishan Aklog博士来做结束语。请继续。
Lishan Aklog:很好。谢谢大家抽出时间。和往常一样，感谢所有的好问题，我真的相信我们有一个很好的讨论。希望你们能感觉到我们真的很兴奋。我们有很多近期活动和里程碑，从本周的DDLB会议开始，随后是一系列活动，我们与经纪人的约定，即将到来的MolDX会议，更多的数据，我们没有真正讨论过，这些数据将在我们已经汇总的数据包之外出现。因此，我们期待着让您了解我们的新闻发布和定期电话会议的进展情况。和往常一样，了解我们的新闻、更新和活动的最佳方式是在Lucid Investor Relations网站上注册电子邮件提醒，在社交媒体上关注我们，包括Twitter、linkedIn和我们的网站，有任何直接问题随时联系马特。谢谢大家，祝你们有美好的一天。
接线员:女士们，先生们，今天的电话会议到此结束。非常感谢您的参与。您现在可以断开连接。
本文是在人工智能的支持下生成的，并由编辑审阅。欲了解更多信息，请参阅我们的T&C。
