Lucid Diagnostics Inc (LUCD) 2022 Q4 法說會逐字稿

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  • Operator

    Operator

  • Welcome to the Lucid Diagnostics Business Update and Fourth Quarter 2022 Financial Results Conference Call. (Operator Instructions)

    歡迎來到 Lucid Diagnostics 業務更新和 2022 年第四季度財務業績電話會議。 (操作員說明)

  • I would now like to turn the call over to your host, Michael Parks, Vice President, Investor Relations. Mr. Parks, you may begin, Sir.

    我現在想把電話轉給你的主持人,投資者關係副總裁邁克爾帕克斯。帕克斯先生,您可以開始了,先生。

  • Michael Parks

    Michael Parks

  • Thank you, Paul. Good morning, everyone. Thank you for participating in today's fourth quarter 2020 business update -- fourth quarter 2020 business update call. The press release announcing our business update for the company and financial results for the year ended December 31, 2022, is available on Lucid's website.

    謝謝你,保羅。大家,早安。感謝您參加今天的 2020 年第四季度業務更新——2020 年第四季度業務更新電話會議。宣佈公司業務更新和截至 2022 年 12 月 31 日止年度財務業績的新聞稿可在 Lucid 的網站上查閱。

  • 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, and these forward-looking statements are subject to known and unknown risks, and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to suffer are described in the disclaimer and in our filings with the U.S. Securities and Exchange Commission.

    請花點時間閱讀新聞稿中有關前瞻性陳述的免責聲明。業務更新新聞稿和本次電話會議均包含前瞻性陳述,這些前瞻性陳述受已知和未知風險以及可能導致實際結果與所作陳述存在重大差異的不確定性的影響。免責聲明和我們提交給美國證券交易委員會的文件中描述了可能導致實際結果受到影響的因素。

  • For a listed and a description of these and other important risks and uncertainties that may affect future operations, see Part I, Item IA entitled Risk Factors and Lucid's most recent Annual Report on Form Q-10 filed with the SEC, and subsequent updates filed with 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 day or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

    有關可能影響未來運營的這些和其他重要風險和不確定性的列出和描述,請參閱第一部分,題為風險因素的項目 IA 和 Lucid 向美國證券交易委員會提交的最新 Q-10 表格年度報告,以及隨後向美國證券交易委員會提交的更新季度報告 10-Q 表格以及任何後續的 8-K 表格備案。除法律要求外,Lucid 不承擔任何公開更新或修改任何前瞻性陳述的意圖或義務,以反映預期或預期可能成為現實或可能影響實際結果可能性的事件、條件或情況的變化將不同於前瞻性陳述中包含的內容。

  • I would like now to turn the call over to Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics. Dr. Aklog?

    我現在想把電話轉給 Lucid Diagnostics 董事長兼首席執行官 Lishan Aklog 博士。阿克洛博士?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Thank you, Mike. And thank you, everybody, for joining us this morning. I look forward to giving you a positive update on our activities for the past quarter in 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, part of the open end in our press releases in the evening prior.

    謝謝你,邁克。感謝大家今天早上加入我們。我期待著在最近幾周向您介紹我們過去一個季度的活動的積極更新。正如那些與我們一起工作了一段時間的人所注意到的那樣,我們已經改變了時間,希望能更好地為我們的股東服務,以便在早上召開季度電話會議,這是前一天晚上我們新聞稿中開放式會議的一部分.

  • So I'll start with some recent highlights before doing a bit of background and then diving further in some 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. And a rapidly increasing Satellite Lucid Test Center activity that is now driving nearly 1/3 of our testing volumes.

    因此,我將從最近的一些亮點開始,然後介紹一些背景知識,然後進一步深入探討一些細節。我們對過去一個季度取得的穩步重大進展感到非常興奮。正如您將看到的,EsoGuard 測試量增長依然強勁,而且我們看到了一些不錯的加速,尤其是在本季度。 Satellite Lucid 測試中心活動的快速增長現在推動了我們近 1/3 的測試量。

  • We're very excited to report that we've secured in-network EsoGuard contract with the largest secondary PPO, Multiplan, and this provides the access to EsoGuard approximately 60 million consumers of that participated in their networks. Our commercial payor engagement and claims history is accelerating. In-network, EsoGuard contracts are now averaging over $2,000 per test. And all of the PPO 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 contract and 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.

    我們非常高興地報告說,我們已經與最大的二級 PPO Multiplan 簽訂了網絡內 EsoGuard 合同,這使參與其網絡的大約 6000 萬消費者能夠訪問 EsoGuard。我們的商業付款人參與和索賠歷史正在加速。在網絡中,EsoGuard 合同現在平均每次測試超過 2,000 美元。我們獲得的所有 PPO 合同的定價都等於或高於 Medicare 費率。我稍後會深入探討這個問題,但我們已經啟動了一項對我們來說非常重要的計劃。我們稱之為我們的直接合同和戰略舉措。這裡的目標是直接與大型 ASO 或僅管理服務的自保雇主、工會和其他此類實體接觸。

  • As we reported in the press release, we had a successful launch of our high-volume CheckYourFoodTube events, and we have a robust near-term pipeline of additional events coming up in the next month or 2. Our laboratory, we're very proud to say, handle the unexpected weak record peak volumes from these events, and this reflects a lot of effort we've made in enhancing our operational efficiencies.

    正如我們在新聞稿中報導的那樣,我們成功推出了高容量的 CheckYourFoodTube 活動,並且我們有一個強大的近期管道,即將在下個月或 2 月推出其他活動。我們的實驗室,我們感到非常自豪可以說,處理這些事件中意外的弱記錄峰值量,這反映了我們在提高運營效率方面所做的大量努力。

  • We received FDA clearance to market a non-sterile version of EsoCheck. This increases our margins and mitigate potential supply chain issues associated with sterilization. We're making good progress collecting clinical utility data, which is a key driver of future in-network commercial payor contracting. And as we'll describe in more detail, we secured financing of just under $25 million, which extends our cash runway well into 2024.

    我們獲得了 FDA 的批准,可以銷售非無菌版本的 EsoCheck。這增加了我們的利潤並減輕了與滅菌相關的潛在供應鏈問題。我們在收集臨床效用數據方面取得了良好進展,這是未來網絡內商業付款人合同的關鍵驅動因素。正如我們將更詳細地描述的那樣,我們獲得了不到 2500 萬美元的融資,這將我們的現金跑道延伸到 2024 年。

  • For those of you who are new to the story, just 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 precancer detection, specifically in patients with long-standing chronic heartburn or gastroesophageal reflux disease, also known as CERD, who are at risk of developing highly esophageal cancer. And our mission is very simple, which is -- it is to prevent death from this cancer in adverse patients with chronic heart burn.

    對於那些剛接觸這個故事的人來說,這裡只有幾張幻燈片可以為您提供一些背景知識。 Lucid Diagnostics 是一家商業階段的癌症預防醫學診斷公司。我們專注於早期癌前病變檢測,特別是長期患有慢性胃灼熱或胃食管反流病(也稱為 CERD)的患者,這些患者有患高度食管癌的風險。我們的使命非常簡單,那就是——防止患有慢性心臟燒傷的不良患者死於這種癌症。

  • The data on esophageal adenocarcinoma is awful. It's highly lethal and it continues to become more prevalent, about 16,000 death in 2021, a similar number with a slight uptick in 2022. It's -- and the incidence has increased to 500%, far outstripping all other cancers over the last 4 decades. And it's a very, very lethal condition. It's the second most lethal cancer with an over 80% 5-year mortality rate. And most importantly, is Stage I, 5-year mortality. So right at the early stages, it still carries at over 40% mortality rates. So in order to have an impact on those death, early precancer detection is necessary. And that's not currently occurring. It hasn't historically occurred and less than 5% of those patients who are recommended for screening are undergoing traditional endoscopy, and that's where we come to play.

    食管腺癌的數據很糟糕。它具有很高的致死性,並且繼續變得更加普遍,2021 年約有 16,000 人死亡,2022 年的死亡人數與此相似,但略有上升。在過去 4 年中,發病率已增至 500%,遠遠超過所有其他癌症。這是一種非常非常致命的情況。它是第二大致命癌症,5 年死亡率超過 80%。最重要的是,第一階段,5 年死亡率。所以就在早期階段,它的死亡率仍然超過 40%。因此,為了對那些死亡產生影響,早期癌前檢測是必要的。而這目前還沒有發生。這在歷史上從未發生過,在推薦進行篩查的患者中,只有不到 5% 的患者正在接受傳統的內窺鏡檢查,而這正是我們要發揮作用的地方。

  • So 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 precancer. EsoGuard is an esophageal DNA test that uses next-generation sequencing to detect early changes in the precancerous conditions, as well as cancer. And EsoCheck is a noninvasive cell collection device that allows the samples to be performed accurately in an in-office (inaudible). We were very proud last year, and we're excited that both major gastroenterology societies, the American College of Gastroenterology and American Gastroenterological Association has now support EsoCheck as an alternative -- an acceptable alternative to endoscopy for the early detection of this precancer to prevent death from of this cancer.

    因此,我們的主導產品 EsoGuard 和 EsoCheck 是第一個也是唯一一個商業化的測試,能夠作為一種廣泛的篩查工具,通過早期檢測食管癌前病變來預防食管癌死亡。 EsoGuard 是一種食管 DNA 測試,它使用下一代測序來檢測癌前病變和癌症的早期變化。 EsoCheck 是一種無創細胞採集設備,可以在辦公室(聽不清)準確地進行樣本採集。去年我們感到非常自豪,我們很高興兩個主要的胃腸病學會,美國胃腸病學會和美國胃腸病協會現在都支持 EsoCheck 作為一種替代方法——一種可接受的內窺鏡檢查替代方法,用於早期檢測這種癌前病變以預防死於這種癌症。

  • The commercial opportunity here is large. The minimum at-risk population defined by these guidelines, the most recent updated guidelines, it's 30 million. Medicare has established payment of $1,938. And we will show you later that, 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 numbers.

    這裡的商機很大。這些指南定義的最低風險人群,最新更新的指南,是 3000 萬。 Medicare 已確定支付 1,938 美元。我們稍後會向您展示,支付流程受到尊重,這導致了數千萬美元的巨大潛在市場。我們的毛利率也非常高,超過 90%,並且我們取得了一些進展。我們將再次強調降低 COGS 並使我們達到 90% 或更高的數字。

  • Our commercial strategy is now really very well owned. We have 2 referral sources that we target, primary care physicians and specialists and institutions. And you can see here that our interaction with them is different when we discuss with primary care physicians, we're just encouraging them to -- we're educating them and then encouraging them to order the test as they would any other cancer screening test or like just doing DNA testing or any other test. With the specialist and with institutions, there's an opportunity to build a consolidated program, centered around EsoGuard that's focused on esophageal cancer, precancer and gastroesophageal refluxes.

    我們的商業戰略現在真的非常好擁有。我們有 2 個目標推薦來源,初級保健醫生、專家和機構。你可以在這裡看到,當我們與初級保健醫生討論時,我們與他們的互動是不同的,我們只是鼓勵他們——我們正在教育他們,然後鼓勵他們像進行任何其他癌症篩查測試一樣訂購測試或者只是做 DNA 測試或任何其他測試。與專家和機構一起,有機會建立一個以 EsoGuard 為中心的綜合計劃,重點關注食管癌、癌前病變和胃食管反流。

  • We also now have 3 modalities by which the -- where the cell collection procedure is performed, where the EsoCheck procedures performed, in that the operator is different. We have our physical Lucid Test Centers, which are now 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 referred 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're already scheduled at the physician's office, and we're able to provides at a very attractive expansion in our physical reach and our overall horizon. And then, of course, at this 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 assistant.

    我們現在還有 3 種方式,通過這些方式 - 執行細胞收集程序的地方,執行 EsoCheck 程序的地方,因為操作員是不同的。我們有實體的 Lucid 測試中心,現在位於 11 個州的 13 個地點。我們自己的執業護士在那裡進行測試,並且繼續保持強勁。在過去的幾個季度中,我們穩步擴大了所謂的 Satellite Lucid 測試中心,我們的執業護士在醫生辦公室安排了幾天的時間,他們可以對已經安排在醫生辦公室的患者執行 EsoCheck 程序醫生的辦公室,我們能夠提供非常有吸引力的擴展我們的身體範圍和我們的整體視野。然後,當然,在這方面,特別是在專家和大型機構中,執業醫師本身通常會執行該程序,無論是他們的護士或執業護士還是他們的醫師助理。

  • We continue to show nice steady growth at EsoGuard testing volume. You'll hear the numbers by quarter. We are reporting the estimated numbers for this quarter as we're now quite close to the end of the quarter. And you can see on an annualized basis, we're on a steady approximately 200% per year compounded growth rate.

    我們繼續在 EsoGuard 測試量方面表現出良好的穩定增長。您會按季度聽到數字。我們正在報告本季度的估計數字,因為我們現在已經非常接近本季度末了。你可以看到,按年化計算,我們的年復合增長率穩定在 200% 左右。

  • 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 tick up over the coming quarters. And this is because that's where most of these patients are, patients with gastroesophageal reflux, they're rarely seen by specialists or institutions, but they're generally managed by their primary care physicians.

    更深入地了解此測試在哪裡進行,這些轉介來自何處,以及誰在執行該程序。我們仍然有大約 60% 的轉診來自初級保健醫生,我們認為這種情況將繼續存在,並且在未來幾個季度可能會增加。這是因為大多數患者都在那裡,胃食管反流患者,他們很少被專家或機構看到,但他們通常由他們的初級保健醫生管理。

  • 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 could 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, so 60% of them tests being -- of the samples being collected are being collected by our nurse practitioners in one of these Centers. And 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. But we still have a robust activity as well in the individual physician practice.

    右側餅圖中突出顯示了另一個重要趨勢。這是實際執行 EsoCheck 細胞收集程序的人員的細分。你可以看到——你可以看到其中 29% 在我們的 Physical Lucid 測試中心,31% 在 Satellite Lucid 測試中心。如果你還記得,這兩者,那麼其中 60% 的樣本都是由我們的執業護士在這些中心之一收集的。在 Satellite Lucid 測試中心進行的佔總數的 31% 的比例正在穩步增加。第三季度為22%。但是我們在個體醫生實踐中仍然有很強的活動。

  • We launched another horizon, another location and opportunity and model for patients to get -- to bring -- to get testing directly to adverse patients in high-volume events, that we're referring to as CheckYourFoodTube precancer testing events. The first event was highly successful, we've been 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. Our nurse practitioner team and others working with the fire departments to test 391 at risk firefighters over 2 weekends. And this was quite successful. The tests were all performed, and we've seen positive. We've seen positive results that are leading to endoscopies in patients, including patients in their 40s and a few in 30s. They're excited that those patients have had the opportunity to get a noninvasive biomarker test that, well, if confirmed on endoscopy, we'll put them in the proper surveillance and monitoring regimen to prevent them from developing esophageal cancer.

    我們推出了另一個視野、另一個位置、機會和模型,讓患者在大量事件中直接對不良患者進行測試,我們稱之為 CheckYourFoodTube 癌前測試事件。第一次活動非常成功,我們一直與聖安東尼奧消防局合作。你可以在那兒的圖像中看到,那是我們在消防部門工作的執業護士。我們的執業護士團隊和其他人員與消防部門合作,在 2 個週末內對 391 名處於危險中的消防員進行了測試。這是相當成功的。所有的測試都進行了,我們看到了積極的結果。我們已經看到積極的結果導致患者接受內窺鏡檢查,包括 40 多歲的患者和一些 30 多歲的患者。他們很高興這些患者有機會接受非侵入性生物標誌物測試,好吧,如果通過內窺鏡檢查得到證實,我們將對他們進行適當的監測和監測,以防止他們患上食道癌。

  • So we're taking this model and where we rinsing and repeating. We have a robust near-term pipeline of future events, targeting unions and other groups across the country, and 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 initiatives that I previously mentioned.

    所以我們採用這個模型,並在其中進行沖洗和重複。我們有針對全國各地的工會和其他團體的未來事件的強大近期管道,並希望在未來幾個月內向您更新這些信息。正如我提到的,這對我們來說是一個非常重要的關注領域,我們將結合我之前提到的直接合同戰略舉措來做到這一點。

  • As I mentioned, we're very excited to have signed an in-network agreement with Multiplan. Multiplan is the largest secondary preferred provider organization one of the -- 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 payors across the country, including all of the top 10 payors and 1.2 million health care providers. They process $74 billion in commercial health plan and medical charges in 2022.

    正如我提到的,我們很高興與 Multiplan 簽署了網絡內協議。 Multiplan 是最大的二級首選提供者組織之一,也是大型健康計劃之外最大的獨立提供者之一。這將 EsoGuard 擴大到大約 6000 萬客戶,Multiplan 與全國 700 家付款人合作,包括所有前 10 名付款人和 120 萬醫療保健提供者。他們在 2022 年處理了 740 億美元的商業健康計劃和醫療費用。

  • If you look overall at our contracting and payment status, really solid progress in this regard. The engagement we're having with commercial payors 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 our own commercial payors. So that's where our immediate focus is. We have 13 commercial payor in-network contracts for EsoGuard that we've secured.

    如果你從整體上看我們的合同和付款狀態,在這方面確實取得了堅實的進展。我們與商業付款人的合作正在加速。正如您在餅圖右側看到的那樣,我們繼續有近 90% 的測試被訂購併由我們自己的商業付款人執行。這就是我們當前的重點所在。我們已經獲得了 13 個 EsoGuard 的商業付款人網絡內合同。

  • And the really gratifying point here now, we've done enough of these is that the price is -- our average contracted price is over $2,000. Our list price is $2,500. And all of our contracts are somewhere between the Medicare -- the PPO contracts are somewhere between the Medicare payment rate of $1,938 that our $2,500 list price. Those are for in-network contracts. For out of network contracts, the out-of-network payments, they continue to respect our charges. The average payment is $1,440, and that lines up nicely with about a 50% to 60% out-of-network benefit that's been control with most planned.

    現在真正令人滿意的一點是,我們已經做了足夠多的事情是價格——我們的平均合同價格超過 2,000 美元。我們的標價是 2,500 美元。我們所有的合同都介於 Medicare 之間——PPO 合同介於 1,938 美元的 Medicare 支付率和我們的 2,500 美元標價之間。這些適用於網絡內合同。對於網絡外合同,網絡外支付,他們繼續尊重我們的收費。平均付款為 1,440 美元,這與大多數計劃控制的大約 50% 到 60% 的網絡外福利非常吻合。

  • The key drivers to expanding future in-network commercial payor 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 larger plans. And this is how you -- 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.

    擴大未來網絡內商業付款人合同的主要驅動力進展順利。這 2 個主要驅動因素正在產生索賠歷史記錄。我們現在正在生成索賠歷史記錄。我們有數百個索賠,其中有許多是更大的計劃。這就是你如何 - 一旦你達到閾值,這就是你如何有機會參與這些關於潛在網絡內覆蓋的計劃,以及他們需要哪些數據以便我們確保網絡內覆蓋。我們也開始看到索賠正在通過拒絕流程和上訴流程,並且我們已經看到一些最初被拒絕的付款在上訴時支付。

  • 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 gratified. We're also in the process of generating the primary focus of the commercial payors, which is demonstrating clinical utility. I'll show a little bit later what that entails, so good solid progress on that.

    我要提醒您,通過我們自己的實驗室提交索賠的整個過程是從第三季度中旬才開始的。所以我們還處於早期階段,但進展確實令人欣慰。我們也在產生商業支付者的主要關注點,即證明臨床效用。稍後我會展示這意味著什麼,在這方面取得了很好的進展。

  • And as I mentioned, we've launched a direct contract and 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. So they have only administrative services through one of the plans, but they control their (inaudible) -- and directly engaging with them, provide the opportunity to secure contracts that are outside of the traditional commercial payor contracts, and an opportunity for meaningful revenue.

    正如我提到的,我們已經啟動了直接合同和戰略計劃。這涉及直接與實體、自保實體(例如雇主、工會、公共服務部門和 ASO 保護傘下的其他實體)接觸。因此,他們僅通過其中一項計劃提供行政服務,但他們控制著他們的(聽不清)——並直接與他們接觸,提供了獲得傳統商業付款人合同之外的合同的機會,以及獲得有意義收入的機會。

  • This model of targeting ASO entities has been used successfully by other cancer detection companies such as GRAIL, and we're studying their model. 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.

    這種以 ASO 實體為目標的模型已被 GRAIL 等其他癌症檢測公司成功使用,我們正在研究他們的模型。並與他們的校友以及其他顧問密切合作,幫助我們快速推動這項計劃,我們認為這將是我們未來活動的重要組成部分。

  • I had mentioned clinical utility data, again this extremely important. The larger plans do -- want to see that there is a clinical utility and performing EsoGuard test. The definition of clinical utility is very straightforward in this case. They want to know that if a physician orders the test, and it comes back positive that the physician -- it will change -- whether it comes back positive or negative, it will alter medical decisioning. 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.

    我已經提到了臨床實用數據,這同樣非常重要。更大的計劃是——希望看到有臨床效用並進行 EsoGuard 測試。在這種情況下,臨床效用的定義非常簡單。他們想知道,如果醫生下令進行檢測,結果是陽性,那麼醫生——它會改變——無論結果是陽性還是陰性,都會改變醫療決策。具體來說,如果它是陽性的,醫生會要求進行確認性內窺鏡檢查。如果它是陰性的,那麼醫生就不會要求進行內窺鏡檢查。

  • And so documenting this very simple fork in the medical decision-making algorithm, it's very important to justify the coverage of this test for payors. And so we are in the process of collecting a multipronged approach to collecting retrospective and prospective data documenting positive clinical utility with the EsoGuard test.

    因此,在醫療決策算法中記錄這個非常簡單的分支,為支付者證明這個測試的覆蓋範圍是非常重要的。因此,我們正在收集一種多管齊下的方法來收集回顧性和前瞻性數據,以證明 EsoGuard 測試具有積極的臨床效用。

  • I'll start with the bearing rough order of when we expect the results to come out. One of the nice things about this CheckYourFoodTube events is that we have an instant shot of hundreds of patients that we can analyze, this initial one as is retrospectively. And that retrospective analysis of prospectively collected data are what happened to the firefighters who got tested, and how did their testing leads to the appropriate medical decision-making.

    我將從我們預計結果出來的大致順序開始。這個 CheckYourFoodTube 事件的好處之一是我們有數百名我們可以分析的患者的即時照片,這是回顧性的。對前瞻性收集的數據進行回顧性分析,了解接受測試的消防員的情況,以及他們的測試如何導致適當的醫療決策。

  • So this study has completed IRB approval and the data is now all in place, and it's being analyzed and it 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 setting from NYU that had 374 patients that were collected. And we'll analyze decision-making and clinical utility, and we expect that to be completed and submitted for peer review shortly.

    所以這項研究已經完成了 IRB 的批准,現在數據已經全部到位,正在分析中,很快就會提交給同行評審。我們還有一項回顧性研究正在進行中,即將完成。這是紐約大學的一個單一中心設置,收集了 374 名患者。我們將分析決策制定和臨床效用,我們希望盡快完成並提交同行評審。

  • The 2 prospective efforts that we have is our list of registry. We had some significant breakthroughs in terms of streamlining that process. And we expect now every patient that is tested by one of our nurse practitioners to be offered the opportunity to enter into the registry, that's allowing us to collect not only clinical utility data but also clinical validity data into the future. And then the (inaudible) study is a prospective multicenter, clinical utility study as well, which has started to grow. And we're looking to get a critical mass, the critical number of patients across these studies. You can see the numbers on the right here by midyear next year.

    我們擁有的 2 項前瞻性工作是我們的註冊列表。我們在簡化流程方面取得了一些重大突破。我們現在希望每一位接受我們的一名執業護士測試的患者都有機會進入登記冊,這使我們不僅可以收集臨床實用數據,還可以收集未來的臨床有效性數據。然後(聽不清)研究也是一項前瞻性多中心臨床效用研究,它已經開始增長。我們希望獲得臨界質量,即這些研究中患者的臨界數量。你可以在明年年中看到右邊的數字。

  • And then finally, there's a prospective virtual patient randomized controlled trial, where physicians are interviewed and receive case (inaudible) and they're asked how they would respond to that. That's a very well-validated approach that payors have accepted in the past for clinical utility. So we're adding that to the mix as well, and we'll expect to enroll about 100 patients in that -- I apologize. I understand that the slides were not showing.

    最後,還有一項前瞻性虛擬患者隨機對照試驗,醫生接受采訪並收到病例(聽不清),並詢問他們將如何回應。這是付款人過去為臨床效用所接受的一種經過充分驗證的方法。所以我們也將其添加到組合中,我們預計會招募大約 100 名患者——我很抱歉。我知道幻燈片沒有顯示。

  • Okay. Let me just spend 20 seconds on each of the slides, just to highlight again. This slide is the commercial payor mix, 90% commercial payors and 12% Medicare and Medicaid. I 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 midyear this year. I apologize for that.

    好的。讓我在每張幻燈片上花 20 秒,再次強調一下。這張幻燈片是商業付款人組合,90% 的商業付款人和 12% 的醫療保險和醫療補助。我為此道歉。這是我剛剛總結的臨床效用數據的幻燈片,顯示了回顧性和前瞻性研究以及我們計劃在今年年中招募的患者數量。我為此道歉。

  • A quick summary on our lab operations. Again, very proud and excited that our laboratory shows -- 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. And we look forward to continuing that low rate moving forward, that provides much more utility to get those numbers down low. Our turnaround times have remained solid over the last couple of quarters at 9 days.

    關於我們實驗室操作的快速總結。再次,非常自豪和興奮,我們的實驗室展示 - 繼續展示提高的運營效率。這張幻燈片中最重要的數字可能是具有足夠 DNA 的樣本比例。這個數字直線下降。當我們第一次從第三方接管實驗室時,它現在運行了 6% 左右,而這個數字要高得多。我們期待著繼續保持低利率,這提供了更多的實用性來降低這些數字。在過去的幾個季度中,我們的周轉時間一直穩定在 9 天。

  • And the CheckYourFoodTube event with the San Antonio Firefighters was sort of a spontaneous stress test for our system and 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. And the laboratory received on 1 day a 200 samples that was able to process that one day with the current -- with our current infrastructure.

    聖安東尼奧消防隊的 CheckYourFoodTube 活動是對我們系統的自發壓力測試,團隊以優異的成績通過了測試。他們能夠在一天內執行 100 次 EsoCheck 程序,而執業護士每天執行 50 次。實驗室在 1 天內收到了 200 個樣本,這些樣本能夠用我們當前的基礎設施處理一天。

  • And just finally, some updates on the manufacturing side. As I mentioned at the beginning, we submitted EsoCheck for market approval -- market clearance, and received the 510(k) to be able to market it without sterilizing. This is a not sterile procedure. This is going into the mouth and the esophagus. And 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 and lead times have been cut dramatically. The sterilization has come across the industry a major source of supply chain issues a constraints that's been eliminated. And ETS sterilization is a hot topic right now with environmental issues, and we've obviated that being a factor in our testing.

    最後,製造方面的一些更新。正如我在開頭提到的,我們提交了 EsoCheck 以獲得市場批准——市場許可,並收到了 510(k) 以便能夠在不滅菌的情況下將其推向市場。這不是無菌程序。這是進入口腔和食道。這樣做的目的是加強我們運營的許多方面。如您所見,在我們的商品成本從轉移到大批量製造商和交貨時間大幅縮短後大幅降低後,它進一步將我們的銷貨成本降低了約 10%。滅菌已成為整個行業供應鏈問題的主要根源,而製約因素已被消除。 ETS 滅菌是目前環境問題的熱門話題,我們已經避免將其作為我們測試的一個因素。

  • We also have a new EsoGuard cell collection kit with a new manufacturer in place and new improved design. And the cost of goods for manufacturing these has also decreased by approximately 20%.

    我們還有一個新的 EsoGuard 細胞收集套件,其中包含新的製造商和新的改進設計。製造這些產品的成本也下降了約 20%。

  • So with that, I'll pass on the slides to Dennis to talk about our financial.

    因此,我將把幻燈片傳給丹尼斯,讓他談談我們的財務狀況。

  • Dennis M. McGrath - CFO, President & Secretary

    Dennis M. McGrath - CFO, President & Secretary

  • Thanks, Lishan, and good morning, everyone. If we go to the next slide, Lishan. So the Board has authorized a $20 million preferred offering at 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 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.

    謝謝,李山,大家早上好。如果我們轉到下一張幻燈片,梨山。因此,董事會已授權以 1100 萬美元的有擔保可轉換債券發行 2000 萬美元的優先股。我們完成了 1400 萬美元優先股的初步關閉,並在 5 月底之前完成剩餘的 600 萬美元。本次融資按照納斯達克市場收盤價規則定價。合格投資者由我們 IR 公司熟悉的家族辦公室和一些長期高淨值股東牽頭,共有四名參與者對公司有著共同的長期願景。

  • 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 2 years. Additionally, 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 interest is only for 6 months. The note of interest is only for 6 months and has a $5 voluntary conversion price and a 7.9% interest rate.

    在探索了各種替代方案之後,這種首選結構通過將有吸引力的股息與持有股票超過 2 年的強烈動機相匹配,為公司和投資者創造了雙贏。此外,昨天,我們與認可投資者簽訂了一項證券購買協議,發行 1100 萬美元的可轉換債券,該投資者多年來為 PAVmed 提供了相同類型的結構,目前以類似條款持有 PAVmed 的現有債務。我們預計將在未來幾天內完成融資。票據利息僅為 6 個月。利息票據期限僅為 6 個月,自願轉換價為 5 美元,利率為 7.9%。

  • 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 improving reimbursement. A runway is substantially elongated through deepened 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.

    攤銷要到 6 個月才開始,然後我們可以用現金或股票支付。這兩種結構都將庫存長期排除在市場之外,就優先股而言可能為 2 年,這使公司能夠完成其臨床效用研究和改善報銷的工作。到 2024 年,跑道將大大延長。在備考基礎上,加上我們年初的現金,備考現金約為 4600 萬美元。

  • For the fourth quarter, the change in cash from the third quarter was $4.5 million. Please refer to the two Form 8-Ks that were published last evening for additional details on both financings. So the summary of 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 stand-alone Lucid financials, we apologize for that. We will be publishing PAVmed's released this afternoon, which include both PAVmed's consolidated and Lucid's standalone.

    第四季度,現金較第三季度的變化為 450 萬美元。請參閱昨晚發布的兩份 8-K 表格,了解有關這兩項融資的更多詳細信息。因此,我們在昨晚發布的新聞稿中報告的第四季度和當年的財務業績摘要將得到更正,因為這些表格反映了 PAVmed 的合併運營而不是獨立的 Lucid 財務,我們為此深表歉意。我們將發布今天下午發布的 PAVmed,其中包括 PAVmed 的綜合版和 Lucid 的獨立版。

  • On the next 3 slides, I'll emphasize a few key highlights from the quarter. I'd encourage you to consider those remarks in the context of the full disclosure covered in our annual report on Form 10-K that was filed with the SEC last night and is available on our website.

    在接下來的 3 張幻燈片中,我將強調本季度的幾個主要亮點。我鼓勵您在我們昨晚向美國證券交易委員會提交的 10-K 表格年度報告中全面披露的內容中考慮這些言論,該報告可在我們的網站上找到。

  • So on the balance sheet. You see the year-on-year changes, of the cash, as mentioned from the third quarter to the fourth quarter was a $4.5 million sequential decrease, and it was $31 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 loose 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 inflation of the balance sheet in the 10-K.

    所以在資產負債表上。你看,從第三季度到第四季度,現金的同比變化是環比減少 450 萬美元,全年為 3100 萬美元。供應商應付款項在連續一個季度和一年中相對持平,被 PAVmed 的公司間債務所抵消,該債務在 12/31 時增加到 330 萬美元,並且兩個董事會都授權 Lucid 能夠以股票而不是現金支付,以保持現金處於寬鬆水平。截至今天,包括未歸屬的 RSA 在內的已發行股票為 4340 萬股。 GAAP 流通股以及 10-K 資產負債表的膨脹反映在幻燈片上。

  • Next slide. So, Slide 20 compares this year's fourth quarter and last year's fourth quarter of certain key items as well as a year-over-year comparison. I 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.

    下一張幻燈片。因此,幻燈片 20 比較了今年第四季度和去年第四季度的某些關鍵項目以及同比比較。我相信您會根據幻燈片底部關於補充信息(尤其是非 GAAP 信息)的警告性披露來審閱我評論中的信息。第四季度的收入反映了該季度的實際現金收入。前一年反映了我們在去年早些時候建立自己的實驗室之前從第三方實驗室收到的固定月費。

  • Revenue recognition, a key determiner is the probability of collection as we've mentioned in our calls in the past. So the vast majority of patient out-of-network claims 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 GAAPs, ASC 606, revenue recognition guidelines. And presently, there is insufficient predictive data to reflect revenue (inaudible). Our GAAP and our non-GAAP loss for the fourth quarter, $10.5 million is fairly flat compared to the third quarter loss of $10.2 million.

    正如我們過去在電話中提到的那樣,收入確認是一個關鍵的決定因素是收款的可能性。因此,絕大多數患者的網絡外索賠提交意味著收入確認發生在實際收集索賠時,我們正處於早期階段,而不是患者報告開具發票並提交報銷時。正如您將在我們的 10-K 中看到的那樣,這在 GAAP、ASC 606、收入確認准則的行話中稱為可變對價。目前,沒有足夠的預測數據來反映收入(聽不清)。我們第四季度的 GAAP 和非 GAAP 虧損為 1050 萬美元,與第三季度的虧損 1020 萬美元相比持平。

  • 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.

    幻燈片 21 是我們所反映期間的運營費用的圖形說明。非 GAAP 運營支出總額環比持平。收入成本主要包括 EsoCheck 設備、實驗室用品和固定實驗室設施成本。它在我們的 10-K 和 10-Q 中顯示為與其他診斷公司的做法一致的運營費用。銷售和營銷的增長被研發和 G&A 的減少所抵消,這使得運營費用相對持平。

  • So with that, operator, let's open it up for questions.

    因此,操作員,讓我們打開它來提問。

  • Operator

    Operator

  • (Operator Instructions) And our first question comes from Kyle Mikson from Canaccord Genuity.

    (操作員說明)我們的第一個問題來自 Canaccord Genuity 的 Kyle Mikson。

  • Kyle Alexander Mikson - Analyst

    Kyle Alexander Mikson - Analyst

  • Can you hear me now?

    你能聽到我嗎?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes, we can.

    我們可以。

  • Kyle Alexander Mikson - Analyst

    Kyle Alexander Mikson - Analyst

  • So congrats on the results. On the effect of ASP here was $95, (inaudible) denial the rate for reimbursement seems like still pretty high. Cash operation's pretty low like super surprising, I guess. But just the ASP dynamics, are you talking about out-of-network $1,400 payment and then commercial payors, $2,000, PPOs at the Medicare rate, which is like almost 2,000 as well. So would you mind just walking through why the revenue per test is so low and when that infraction point occurs and what kind of like catalyzes that?

    所以祝賀結果。這裡的平均售價為 95 美元,(聽不清)否認報銷率似乎仍然很高。我猜現金操作非常低,非常令人驚訝。但只是 ASP 動態,你是在談論網絡外支付 1,400 美元,然後是商業付款人,2,000 美元,按 Medicare 費率計算的 PPO,也差不多是 2,000 美元。那麼,您是否介意簡單介紹一下為什麼每次測試的收入如此之低以及何時出現違規點以及是什麼原因促成的?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • I'll let Dennis dive into that deeper, but maybe just provide a high level. This is a bit of a moving target, right, because the average life cycle of -- the cycle for payment can run up to 90 days. There's claims adjudication valves and so forth. So what we're seeing in any particular quarter in revenue is really a snapshot of what was going on with submissions a while back. But I'll let Dennis tell you a little bit further in detail.

    我會讓丹尼斯更深入地探討,但也許只是提供一個高水平的。這是一個有點移動的目標,對吧,因為支付週期的平均生命週期可以長達 90 天。有索賠裁決閥等。因此,我們在任何特定季度看到的收入實際上是前段時間提交情況的快照。但我會讓丹尼斯更詳細地告訴你一點。

  • Dennis M. McGrath - CFO, President & Secretary

    Dennis M. McGrath - CFO, President & Secretary

  • Correct. So 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 and appeal, as well as asking for additional information. That will -- that steam will pick up as the year unfolds.

    正確的。因此,正如 Lishan 所指出的,提交的索賠確實需要一些時間來處理,從第四季度開始,這些金額開始陸續流入。有超過 200 家保險公司在第四季度和 2019 年年初之前收到了索賠單第一季度。在第一季度,我們開始加速收款。現在還處於遊戲初期,正在根據拒絕和上訴以及要求提供更多信息來裁定索賠。這將——隨著時間的推移,這種勢頭將會增強。

  • 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. We are getting paid from some of the larger players, United, particularly, and we're getting paid 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 full reimbursement, there will be a match in terms of when the claims are submitted and the cash is collected. But for now, there is a large gap between those time frames.

    第四季度並不能說明到目前為止第一季度的結果,我們預計未來幾個季度的報銷情況將會有所改善,Multiplan 當然也有助於實現這一目標。我們從一些較大的球員那裡得到報酬,尤其是曼聯,我們得到的是網絡外費率。積壓的訂單應該會繼續增加。因此,最終,我們希望及時,當我們獲得全額報銷時,提交索賠和收取現金的時間將會匹配。但就目前而言,這些時間框架之間存在很大差距。

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • 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, so basically mid-to-late third quarter. So the fourth quarter results, if you kind of take that typical 90-day cycle. And those cycles are longer for new tests, when those tests are more established, they tend to -- the turnaround time tends to be longer. So the fourth quarter numbers really reflect a small portion of the claims that were submitted in the -- in only half of the third quarter.

    如果我可以添加一些東西。再次強調這裡的相移類型。我們從 8 月底開始提交索賠,所以基本上是在第三季度中後期。所以第四季度的結果,如果你採用典型的 90 天週期。對於新測試,這些週期更長,當這些測試更加成熟時,它們往往——周轉時間往往更長。因此,第四季度的數字確實反映了在第三季度的一半時間裡提交的索賠的一小部分。

  • 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 -- 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 have been denied is very low right now. So 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.

    我要說的另一點是,這些都是早期數字。我們對此沒有很好的分母。但是我們沒有——你提到的拒絕率的數量,實際上還沒有拒絕率。因為目前經過完整裁決程序被拒絕的索賠數量非常少。因此,大多數索賠要么——要么已經支付,要么更可能的是,其中絕大多數仍在努力完成這一過程。

  • Kyle Alexander Mikson - Analyst

    Kyle Alexander Mikson - Analyst

  • Maybe just sticking on a similar kind of subject, it's really good to see the kind of projection for the first quarter, test performed here, like 1,500. Looks like, I believe that 36% growth sequentially, that's awesome. Any reason why that type of sequential growth can't continue going forward to potentially accelerate from there? And is there anything about maybe seasonality or other dynamics that could maybe inflate that 1Q number? I mean it sounds very reasonable, but just trying to think about how that progresses throughout 2023?

    也許只是堅持類似的主題,很高興看到第一季度的預測,在這裡進行的測試,比如 1,500。看起來,我相信連續增長 36%,這太棒了。為什麼這種類型的連續增長不能繼續前進並可能從那裡加速?是否有任何可能誇大 1Q 數字的季節性或其他動態?我的意思是這聽起來很合理,但只是想想想這在整個 2023 年會如何發展?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes. No, I think 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. So there's some pent-up demand in both Florida and California there that we're addressing. But if you kind of look at the overall trend on the line, that 36%, something like that quarter-on-quarter, about 200% or so compounded growth rate, I think, is sustainable for some period of time. And obviously, the goal is to continue to grow that.

    是的。不,我想如果你看那張幻燈片,你會在第四季度看到一些季節性,正如你所知,凱爾,這在其他公司很常見。在第四季度,我們還必須通過一些合規結構,在我們幾個較大的州建立一些合規結構,因為它與如何建立 Satellite Lucid 測試中心有關。因此,我們正在解決佛羅里達州和加利福尼亞州的一些被壓抑的需求。但如果你看一下整體趨勢,我認為 36%,類似於季度環比,大約 200% 左右的複合增長率,在一段時間內是可持續的。顯然,目標是繼續發展。

  • I think you know as we've said in the past, we're not on full throttle, all right? We've decided to plateau our sales team. And that sales expense that Dennis show, we expect that to be flat for this year. And we think our current team can continue to drive test volume growth as we start getting more predictable payment and improve on our contracting. And we think these initiatives such as the high-volume testing events as well as direct contracting with ASO type entities, will be -- will play an important role in that growth over time.

    我想你知道我們過去說過,我們沒有全力以赴,好嗎?我們決定穩定我們的銷售團隊。丹尼斯展示的銷售費用,我們預計今年會持平。我們認為,隨著我們開始獲得更可預測的付款並改善我們的合同,我們目前的團隊可以繼續推動測試量的增長。我們認為這些舉措,例如大量測試活動以及與 ASO 類型實體的直接簽約,將隨著時間的推移在這種增長中發揮重要作用。

  • Kyle Alexander Mikson - Analyst

    Kyle Alexander Mikson - Analyst

  • And similarly, just thinking about test order per ordering position, I guess, and I know your test center strategy is not on hold, but you're just sort of investing in your current number, I guess, of centers. And in the Multiplan, you had some providers there as well and some business will get on board and I suppose to start ordering more and more. So I mean that denominator number is sort of -- is still pretty healthy. I'm just wondering if test per doc is increasing. Has that progressed through the -- like since the loss in 20221 -- is there a platform win, like just any kind of trends?

    同樣,我想,只是考慮每個訂購位置的測試訂單,我知道你的測試中心策略沒有被擱置,但我猜你只是在投資你目前的中心數量。在 Multiplan 中,你也有一些供應商,一些企業會加入,我想開始訂購越來越多。所以我的意思是分母數字有點——仍然很健康。我只是想知道每個文檔的測試是否在增加。這是否已經取得進展——就像自 20221 年失利以來——是否有平台獲勝,就像任何一種趨勢一樣?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes. 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, that geographically now. And the fact that we can do Satellite Test Centers has given us -- again, we're not -- just to be clear, we're not putting the physical locations on hold. They still or remain an important anchor and are key in areas where we -- as sort of the headquarters for our clinical team, our nurse practitioner team. But 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 test in two weekends. All of that is enhancing our geographic reach and the number of providers.

    是的。我的意思是我們關注的重點——我沒有一個單一的數字可以讓你捕捉到這一點。我們關注的是,我們有很多供應商。正如您所提到的,我們現在在地理上已經做到了。我們可以做衛星測試中心的事實已經給了我們 - 再一次,我們不是 - 只是要明確一點,我們不會擱置物理位置。他們仍然或仍然是一個重要的支柱,並且是我們所在領域的關鍵 - 作為我們臨床團隊,我們的執業護士團隊的總部。但事實是,他們可以在當地地理範圍內開展分支機構,並真正登上飛機前往聖安東尼奧,並在兩個週末進行 400 次測試。所有這些都在擴大我們的地理覆蓋範圍和供應商的數量。

  • But 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. And it is working. So we have figured out ways -- the issue with repeat ordering and stickier business is not about sort of loss of interest. It's just more a matter of attention.

    但我們的銷售團隊現在非常專注於專注於更具粘性的業務。在讓客戶繼續訂購剪輯後,銷售代表現在越來越受到激勵。它正在工作。所以我們想出了辦法——重複訂購和粘性業務的問題與興趣的喪失無關。只是多了一個注意的問題。

  • And 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's nurse practitioner is going to come to the practice on a particular day does bring the whole issue of esophageal precancer testing front and center. And if they know that the NP is going to be there 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.

    我想我之前已經提到過這一點,但我要重申一下,我們真正喜歡衛星模型的一件事是有一天 Lucid 的執業護士將在特定的一天來練習確實將食管癌前病變檢測的整個問題帶到了前沿和中心。而且,如果他們知道 NP 將在下週或幾週後到達那裡,它就會比以前更加突出和居中,我們的代表必須有多個聯繫點才能保持突出和居中。

  • So yes, again, I 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.

    所以,是的,再一次,我沒有關於你的硬數據,但趨勢實際上是好的。我們的業務越來越有粘性,但我們也在——我們兩者都在做。我們試圖同時獲得廣度和深度,同時保持一種中速方法,直到我們獲得更可預測的報銷。

  • Kyle Alexander Mikson - Analyst

    Kyle Alexander Mikson - Analyst

  • Okay. Just one last one before I hop off. So 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 ODTs like in the near future, I guess. I know you delayed the BE1, BE2 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 1 or 2 years or 24 months. What's the plan B here?

    好的。在我下車前的最後一個。所以我想在 FDA 上,很明顯,有很多來回,但我猜 FDA 似乎會像在不久的將來那樣推動對 ODT 的監管。我知道你推遲了 BE1、BE2 試驗。但是,如果 FDA 在未來 1 年或 2 年或 24 個月內開始嚴厲打擊測試,您提供 EsoGuard 的能力會發生什麼變化。這裡的計劃 B 是什麼?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes. 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 1 or 2 year events. There are grandfathering clauses. We have confidence with regard to where our risk, where we will rely on our risk assessment that we think we'll have the appropriate data to be able to continue uninterrupted. And so we're monitoring closely. We've established long-term strategies to mitigate that. On our -- on the clinical utility side, we will start getting clinical utility data.

    是的。我們正在密切關注有效法案以及 FDA 最近關於該領域規則制定的聲明。我們在短期內沒有任何擔憂。這些都是長期的。這當然不是 1 年或 2 年的事件。有祖父條款。我們對我們的風險在哪裡有信心,我們將在哪裡依賴我們的風險評估,我們認為我們將擁有適當的數據,以便能夠不間斷地繼續。所以我們正在密切監視。我們已經制定了長期戰略來緩解這種情況。在我們——在臨床效用方面,我們將開始獲取臨床效用數據。

  • I should mention that there are other sources of clinical utility data from the Betternet study, the NCI-sponsored studies that were anchored by the Betternet consortium that turn around Case Western Reserve. Those studies are collecting data. They're starting to get critical masses of data with good results, and we should start -- starting to see those come online in meetings and in peer review publications, well before we have our BE2 data out. So we're monitoring, but we don't have any concerns in the near future.

    我應該提一下,Betternet 研究還有其他臨床實用數據來源,NCI 贊助的研究由 Betternet 財團主持,扭轉了 Case Western Reserve 的局面。這些研究正在收集數據。他們開始獲得大量的關鍵數據並取得了良好的結果,我們應該開始——在我們發布 BE2 數據之前,開始在會議和同行評審出版物中看到這些數據上線。所以我們正在監控,但我們在不久的將來沒有任何擔憂。

  • Operator

    Operator

  • And our next question comes from Ross Osborn of Cantor Fitzgerald.

    我們的下一個問題來自 Cantor Fitzgerald 的 Ross Osborn。

  • Ross Everett Osborn - Research Analyst

    Ross Everett Osborn - Research Analyst

  • So generally a couple of calls I may have missed this, but where did you end the year in terms of sales reps and what are the hiring plans for 2023?

    所以一般來說我可能錯過了幾個電話,但是你在銷售代表方面結束了這一年,2023 年的招聘計劃是什麼?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • 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 our 40 sales personnel. As well as the clinical support team, the nurse practitioners and clinical specialists, we've added a couple of staffs to make sure we have sufficient coverage there. And 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 will be opportunities to dial that up if the reimbursement side accelerates more quickly than we're prepared to keep that flat.

    我們有 40 個,這是我們在 1 月份的戰略更新電話會議中說過的目標,這反映了一些裁員和一些回填。但我們已經安頓了 40 名銷售人員。除了臨床支持團隊、執業護士和臨床專家,我們還增加了幾名員工,以確保我們在那裡有足夠的覆蓋面。現在的計劃是在這一年中保持平穩,並讓這個團隊繼續推動我剛剛與 Kyle 談到的那種測試增長量。當然,如果報銷方面的加速比我們準備保持持平的速度更快,我們就有機會提高它。

  • Ross Everett Osborn - Research Analyst

    Ross Everett Osborn - Research Analyst

  • And then 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? And then as a follow-up, what can you do to accelerate satellite testing and activity?

    然後我意識到現在的重點是至少在近期內進行衛星測試,但是您能否討論一下您相對於最初階段地理部署的地理存在?然後作為後續行動,您可以做些什麼來加速衛星測試和活動?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes. I just want to kind 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. There's really good sales coverage right now, and our sales team coverage is broader than the 11 states and the 13 lab centers that we -- the physical locations that we currently have.

    是的。我只是想重述一下,以確保這裡沒有誤解——我們沒有改變,也沒有暫停物理測試中心模型,它仍然是我們的支柱。那是我們執業護士的實際工作地點,但他們有機會在更廣闊的地理區域移動和進行測試。現在的銷售覆蓋範圍非常好,我們的銷售團隊覆蓋範圍比我們目前擁有的 11 個州和 13 個實驗室中心更廣泛。

  • And so 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. So we're not -- certainly, we're not -- with 40 reps, we're not covering the entire -- every single state or every single metropolitan area. But the geographic coverage is broader, and it certainly covers the major states, particularly California, Texas and Florida, Ohio those are -- remain big locations for us.

    因此,例如,在佐治亞州和我們沒有物理測試中心的其他州,我們有機會使用衛星測試中心模型來支持越來越多的活動,我們可以支持這些活動。所以我們不是 - 當然,我們不是 - 有 40 個代表,我們沒有覆蓋整個 - 每個州或每個大都市區。但地理覆蓋範圍更廣,它肯定涵蓋了主要州,特別是加利福尼亞州、德克薩斯州和佛羅里達州、俄亥俄州——對我們來說仍然是重要的地點。

  • Operator

    Operator

  • And our next question comes from Mike Matson of Needham & Co.

    我們的下一個問題來自 Needham & Co 的 Mike Matson。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • Just a question on -- so 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?

    只是一個關於 CYFT 活動的問題,你說你確實喜歡那裡的 391 次測試。是否包含在測試編號中?您希望通過這些測試獲得報酬嗎?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • That's an interesting question. So yes, they are included in those numbers and the -- these are commercial patients who have commercial insurance. And so they're not a research project or anything like that. So we do count them in the commercial numbers. We don't know yet, it's an interesting dynamic because generally, for example, typically with the firefighter group, the Firefighter Union is often an ASO, so they have their own decision-making opportunities.

    這是一個有趣的問題。所以是的,它們包含在這些數字中,而且 - 這些是擁有商業保險的商業患者。所以他們不是研究項目或類似的東西。所以我們確實將它們計入商業數字。我們還不知道,這是一個有趣的動態,因為一般來說,例如,通常對於消防員團體,消防員工會通常是一個 ASO,所以他們有自己的決策機會。

  • So you might expect that our ability to engage with them directly. That's why I as 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. And so as we're expanding what's a quite robust pipeline, we're being much more proactive at the beginning about understanding the payor structure within each of these. And working closely with the self-insured entity, typically to set these things up. So we don't know yet, but there's certainly some hope and some promise that the prospects of the payment rates, the percentage of claims that get paid as a result of these tests could be higher. That's our hope, obviously.

    因此,您可能期望我們能夠直接與他們互動。這就是為什麼我說 CYFT 活動與我們的直接簽約計劃緊密相關,對吧?因為我們處理的是典型的——在後勤方面組織這些,特別是與消防隊和工會打交道。因此,當我們擴展一個非常強大的管道時,我們在開始時更加積極主動地了解每個管道中的付款人結構。並與自保實體密切合作,通常是為了設置這些東西。所以我們還不知道,但肯定有一些希望和一些承諾,支付率的前景,由於這些測試而獲得支付的索賠百分比可能會更高。顯然,這是我們的希望。

  • And so it's an attractive aspect of this business because it's a large, high-volume event. It's a good chunk of testing. We can handle that chunk of testing, and it's worth a single entity that -- and our engagements with these entities with the firefighter in particular, has been extraordinarily positive. They understand the need. They're very focused on protecting their members, and it's a very different dynamic than a typical -- than engaged with a typical health plan. So we're quite optimistic. I'm glad you brought that up, but we obviously have to demonstrate that.

    所以這是這項業務的一個有吸引力的方面,因為它是一個大型、高容量的事件。這是一個很好的測試塊。我們可以處理那部分測試,值得一個實體——我們與這些實體的接觸,尤其是與消防員的接觸,一直非常積極。他們了解需求。他們非常專注於保護他們的成員,這是一種與典型的動態截然不同的動態——與參與典型的健康計劃相比。所以我們非常樂觀。很高興你提出來,但我們顯然必須證明這一點。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • And then I think Dennis said the cash, that you used about $30 million of cash in 2022, is that right? And then with the announcement earlier this year of the cost reductions, I think you said you'd reduce your cash burn by about 25%. So that would seem to sort of imply like a low $20 million number for 2023. Is that reasonable?

    然後我想丹尼斯說現金,你在 2022 年使用了大約 3000 萬美元的現金,對嗎?然後隨著今年早些時候宣布的成本削減,我想你說過你會減少大約 25% 的現金消耗。所以這似乎有點暗示 2023 年的 2000 萬美元的數字很低。這合理嗎?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • The burn rate for the first half is going to be in the $7 million, $7.5 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 will bring the burn down for the second half of the year at a larger number.

    上半年的燒錢率將在 700 萬至 750 萬美元之間。然後隨著運營費用繼續保持平穩,應該會逐漸減少。我們估計收藏品將開始以明顯更高的速度改善,這將使今年下半年的銷毀數量更多。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • Sorry, the 7 to 7.5, is that -- that's a quarter number or a --

    抱歉,7 到 7.5 是——那是四分之一數字或——

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • The quarterly number.

    季度數字。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • Quarterly number. Okay. All right. Got it. And then Yes. So with Multiplan, the covered lives there, how do those -- I guess, the geographic concentration of that sort of match up to your sales force and test center locations?

    季度數。好的。好的。知道了。然後是的。因此,對於 Multiplan,被保險人住在那裡,我猜,這種地理集中度如何與您的銷售人員和測試中心位置相匹配?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Multiplan is national. They're in every corner of the country. So we -- our market access team does have a robust process, whereby they look at where payors are and how that aligns with our team. So that's a process that we utilize. And some of the other contracts that we've had, those are regional and that has -- that's much more actionable but 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.

    Multiplan 是全國性的。他們遍布全國各個角落。所以我們 - 我們的市場准入團隊確實有一個強大的流程,他們可以查看付款人的位置以及它如何與我們的團隊保持一致。這就是我們利用的流程。我們擁有的其他一些合同是區域性的,並且具有 - 這更具可操作性,但 Multiplan 確實是一項國家計劃。他們有自己的主要 PPO 網絡,一個互補的 PPO 網絡。因此,有很多機會參與全國各地的活動。

  • Michael Stephen Matson - Senior Analyst

    Michael Stephen Matson - Senior Analyst

  • And then finally, I apologize if you mentioned this earlier and I missed it, but MolDX I mean, you discussed the clinical utility efforts, but when do you think you could make -- take another shot at getting MolDX coverage?

    最後,如果您之前提到過這一點而我錯過了它,我深表歉意,但是我的意思是,您討論了臨床效用工作,但是您認為您什麼時候可以再次嘗試獲得 MolDX 覆蓋?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Just to be clear there's no other shot. The shot is already out there. We're just waiting -- so 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. So it's on their desk. They're looking at it, and they'll get back to us at their time.

    只是要清楚,沒有其他鏡頭。鏡頭已經在那裡了。我們只是在等待——所以我們無事可做。我們去年經歷了這個過程,在 LCD 草案發布後,我們與 MolDX 以及 Noridian 一起參與,MAC 在公開會議過程和評論期間涵蓋了我們的實驗室。提交後,我們無事可做。這只是一場等待的遊戲。所以它在他們的桌子上。他們正在研究它,他們會在他們的時間回复我們。

  • If you recall, it took quite a while from the (inaudible) submission to even get the draft LCD published. So we make no particular predictions about when that will happen. But you did -- you made a good point in that linking at the 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. So until we have sufficient clinical utility data to respond to the LCD, which we won't have until 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 midyear. But we're waiting.

    如果您還記得的話,從(聽不清)提交到發布 LCD 草案都花了很長時間。因此,我們對何時會發生沒有特別的預測。但是你做到了 - 你在臨床實用程序的鏈接中提出了一個很好的觀點。我們響應更新的 LCD 和尋求的能力——請記住,這些是基礎 LCD,它們是測試類別的通用 LCD。要將基礎 LCD 轉換為適用於 EsoGuard 的 Lucid 的特定 LCD,將需要提交臨床實用數據。因此,在我們有足夠的臨床實用數據來響應 LCD 之前,我們要到年中才會有。現在 LCD 的時機實際上並沒有傷害我們,因為我們要到年中才能進行技術提交以將其轉換為測試 LCD。但是我們在等。

  • 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 to remain strongly tilted towards commercial payors with 10%, 12% of the patients being Medicare. So we'll just continue to wait on the Medicare side, while we're pushing really hard full steam ahead on the commercial side.

    但好消息是,我們關注商業方面的原因是,被要求進行檢測的患者的人口統計數據仍然強烈傾向於商業付款人,其中 10%、12% 的患者是醫療保險。因此,我們將繼續在醫療保險方面等待,同時我們正在全力推動商業方面的發展。

  • Operator

    Operator

  • Thank you. And our next question comes from Mark Massaro from BTIG.

    謝謝。我們的下一個問題來自 BTIG 的 Mark Massaro。

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

    Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • So yes, you guys were very clear about what you need to do to show clinical utility. The positives just need to get a confirmatory endoscopy and the negatives just need to not get one, based on the clinician suggestion. So can you give me a sense and maybe confirm that, Lishan, that you plan to submit the clinical utility, was that midyear 2023? And then can you give us a sense for the numbers? I mean, are we looking at like 100 patients, a couple of hundred?

    所以是的,你們非常清楚需要做什麼才能顯示臨床效用。根據臨床醫生的建議,陽性者只需進行內鏡檢查即可,陰性者無需進行。那麼你能給我一個感覺,也許可以確認一下,Lishan,你計劃提交臨床效用是在 2023 年年中嗎?然後你能告訴我們這些數字嗎?我的意思是,我們是在看 100 名患者,還是幾百名?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • I'm going to go back to the previous slide. I hope it will still show, Yes. So let's kind of dig deeper on to this. Hold on a second. I have a technical glitch here, I got to push the audience. Hopefully, you can see the numbers there. So one quick minor correction to your summary, which is otherwise excellent, 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, loss of files and things like that. We just have to document that the physician ordered the endoscopy or they did not order an endoscopy. And even in negative, there are going to be times where an endoscopy is ordered for other reasons, right? But as long as endoscopy was not ordered for screening for esophageal precancer then that shows -- that demonstrates that clinical utility.

    我要回到上一張幻燈片。我希望它仍然會顯示,是的。因此,讓我們更深入地研究一下。稍等一下。我這裡有一個技術故障,我必須推動觀眾。希望你能看到那裡的數字。因此,對您的總結做一個快速的小修正,這在其他方面非常好,臨床實用性意味著什麼。這甚至並不意味著他們必須實際進行內窺鏡檢查。人們失敗了,他們沒有出現等等,文件丟失等等。我們只需要記錄醫生要求進行內窺鏡檢查或者他們沒有要求進行內窺鏡檢查。即使是消極的,有時也會因為其他原因而要求進行內窺鏡檢查,對吧?但只要內窺鏡檢查沒有被要求用於篩查食管癌前病變,那麼就會顯示 - 這證明了臨床實用性。

  • 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, multipronged, 5 different areas that we're focused on here. I like it to be more because each new (inaudible) will be another batch of clinical utility data. The main -- the ones that are the strongest are the 2 list of registry and the control study. Those are the truly prospective studies, which will garner us the most attention from the payors, but all of them are important, and all of them will be useful.

    我在這裡顯示的數字實際上是為了讓您了解我們處理這個問題的方法數量。我的意思是,這是一項全力以赴的多管齊下的工作,我們關注的是 5 個不同的領域。我更喜歡它,因為每個新的(聽不清)都將是另一批臨床實用數據。主要 - 最強的是 2 註冊表和對照研究列表。這些是真正的前瞻性研究,它們將使我們獲得付款人的最多關注,但它們都很重要,而且它們都會有用。

  • So those are our estimates and our targets for midyear, and we will be submitting data as they come in. We don't have to wait for some specific number. Once we have a critical number of patients involved in each of these, we'll be able to submit interim data for peer review. And so by -- it's a little bit hard to know until we have a little bit better trajectory on the projections here, but certainly by midyear, I would expect that we would have some of the -- particularly the retrospective and the CYFT data submitted for peer review and published.

    所以這些是我們對年中的估計和目標,我們將在數據進來時提交數據。我們不必等待某個具體數字。一旦我們有足夠數量的患者參與其中的每一項,我們將能夠提交中期數據以供同行評審。所以到 - 在我們對這裡的預測有更好的軌蹟之前很難知道,但肯定到年中,我希望我們會有一些 - 特別是回顧和提交的 CYFT 數據供同行評審並發表。

  • The other one is maybe a little bit more time. But right now with online journals, turnaround time for peer review is not terribly long. So these are just ballpark numbers, ballpark targets, where we look to end up and hopefully, that makes sense.

    另一個可能要多一點時間。但現在有了在線期刊,同行評審的周轉時間並不算長。所以這些只是大概的數字,大概的目標,我們希望最終達到的目標,希望這是有道理的。

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

    Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • Yes. So yes. So MolDx is likely looking for approximately 200 individuals in a prospective observational study.

    是的。所以是的。因此,MolDx 可能會在一項前瞻性觀察研究中尋找大約 200 人。

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • I think that's about right. We have right now targeted 400 patients in the true prospective studies that concluded in the listed registry. We certainly will be able to combine those. But you're right, because if you think about it, our positivity rate is about 7% to 10%, and that's where you need the numbers, right? So if you have 400 patients, let's say, at a 10% positivity rate, that means there will be 40 patients who are positive and you can show that those 40 patients did not have referred for -- that they did get referred for endoscopy. And then obviously, the other 160 patients, that's on a large number to demonstrate that negatives are not -- sorry, not 160 360 patients, to show that the negatives are not getting reported for cost.

    我認為這是對的。我們現在已經針對 400 名患者進行了真實的前瞻性研究,這些研究在所列登記處結束。我們當然可以將它們結合起來。但你是對的,因為如果你仔細想想,我們的陽性率大約是 7% 到 10%,這就是你需要這些數字的地方,對吧?因此,如果您有 400 名患者,比方說,以 10% 的陽性率,這意味著將有 40 名患者呈陽性,您可以證明這 40 名患者沒有轉診——他們確實接受了內窺鏡檢查。然後很明顯,其他 160 名患者,這是一個很大的數字,以證明陰性不是——抱歉,不是 160 360 名患者,以表明陰性沒有得到成本報告。

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

    Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • Thanks for clarifying that the physician just needs to order it rather than the patient needs to complete the procedure. Cool. All right. So 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. And I think you noted in the press release that firefighters have a higher risk for GERD and esophageal cancer. So -- and I think you indicated that your near-term pipeline for future events is robust. I 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 do you think you might be able to pull off in 2023?

    感謝您澄清醫生只需要訂購它而不是患者需要完成手術。涼爽的。好的。所以我的下一個問題是,聖安東尼奧消防局真的非常有趣,因為根據我的數學計算,這大約是第一季度消防量的 1/4。我想你在新聞稿中指出,消防員患胃食管反流病和食道癌的風險更高。所以 - 我認為你表示你對未來事件的近期管道是強大的。我很想听聽更多關於其他一些高風險群體的信息,你的漏斗是什麼樣的?您認為您可以在 2023 年實現其中的多少?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • So the pipeline is robust. We have, obviously, you're going to focus on your successes first. So the initial focus has been on the other fire departments. And as you mentioned, the key you mentioned there is that, is the published well-established data of a 65% increase risk of esophageal cancer in firefighters is based presumably on environmental exposure. So there are a lot of firefighters, we'll have fire departments, we're picking up the phone and calling a lot of them, and we expect to start seeing more on those sites.

    所以管道是健壯的。顯然,我們已經讓您首先關注您的成功。所以最初的重點是其他消防部門。正如您提到的,您提到的關鍵是,已發布的可靠數據表明消防員患食道癌的風險增加 65%,這可能是基於環境暴露。所以有很多消防員,我們會有消防部門,我們拿起電話給他們打電話,我們希望在這些網站上看到更多。

  • But then as I mentioned, Mark, this sort of falls into kind of the broader -- there are certainly other higher-risk groups. You can think of other Unions, truck drivers, other policemen and other public service groups. But this starts to kind of fold in or melt into the overall approach to direct contract, right, to engage with entities that are very -- one of the things we've learned from engaging with the firefighters, as I mentioned, they're very committed. The level of passion and commitment to their members is high.

    但正如我提到的,馬克,這種情況屬於更廣泛的範圍——當然還有其他高風險群體。你可以想到其他工會、卡車司機、其他警察和其他公共服務團體。但這開始有點融入或融入直接合同的整體方法,對,與非常——我們從與消防員接觸中學到的東西之一,正如我提到的,他們是非常投入。對成員的熱情和承諾水平很高。

  • And so our ability to engage with entities that are self-insured, that -- where the conversation is a very direct one and one that drives -- that's driven by their -- the commitment to do right by their patients is a big opportunity for us and something that we'll look forward to. I'm not really prepared to give you a sort of a number. I think right now, we're going to stick with our trajectories with regard to test volume. We continue -- just to clarify something that comes up occasionally, that this is not a pivot.

    因此,我們與自我保險的實體進行互動的能力,即對話是非常直接的,並且是一種驅動的對話,這是由他們驅動的,他們承諾為患者做正確的事,這是一個巨大的機會我們和我們期待的東西。我真的不准備給你一個數字。我認為現在,我們將堅持我們關於測試量的軌跡。我們繼續 - 只是為了澄清偶爾出現的事情,這不是一個支點。

  • Our traditional approach to primary care physicians, specialists and institutions, that's unchanged, and we continue to drive that hard. And we're certainly working on figuring out how to do both logistically, but so far so good. So we expect to see a good number, probably in the next couple of quarters, we'd be able to give you a little bit more flashed out targets as to what we need to do.

    我們對初級保健醫生、專家和機構的傳統方法沒有改變,我們將繼續努力推動這一點。我們當然正在努力弄清楚如何在邏輯上做到這兩點,但到目前為止一切順利。因此,我們希望看到一個很好的數字,可能在接下來的幾個季度,我們能夠為您提供更多關於我們需要做什麼的閃現目標。

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

    Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • Maybe just my last question. 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 payors 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. But do you think as the year progresses, you might be able to sign whether it's a large national commercial payor or at least some of the regional payors? How should we think about payor coverage?

    也許只是我的最後一個問題。當我們考慮今年剩下的時間時,很高興看到 Multiplan 的覆蓋範圍。只是好奇你是否認為你得到了——我知道聽起來與付款人的對話正在改善。而且您在某些拒絕中獲得報酬這一事實非常好。這些在早期是相對較小的數字。但是你認為隨著時間的推移,你是否可以簽署一個大型的全國商業付款人或至少一些地區付款人?我們應該如何考慮付款人承保範圍?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes. I think the lessons -- the main -- there's 2 lessons. One is really, really want to get the point home that the price is holding. I mean, I really feel like we now have enough that we can feel confident about our -- that the price between Medicare as the 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, in that respect that price is really -- we're developing increasing confidence that our pricing is going to hold.

    是的。我認為課程——主要的——有兩節課。一個是真的,真的想要明白價格持有的觀點。我的意思是,我真的覺得我們現在有足夠的錢讓我們對我們有信心——醫療保險作為底價和我們基於網絡外支付的 2,500 美元標價之間的價格,基於丹尼斯提到的付款,更大的網絡外計劃,在這方面,價格確實是——我們正在增強對我們的定價將保持不變的信心。

  • 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 going to expect based on active and retiring engagements from active and retired medical directors. And the message is quite clear that the -- that, that in order to get a larger plans, it's likely to require us to have that meaningful clinical utility later in the year.

    根據我們的預期,在更大的計劃中,我們舉行了多次諮詢委員會會議和對話。因此,根據現職和退休醫療主管的積極和退休參與,我們可以很好地了解更大計劃的預期。信息非常明確——為了獲得更大的計劃,可能需要我們在今年晚些時候擁有有意義的臨床效用。

  • But in the interim, our conversations with the secondary PPOs, like Multiplan and smaller plans will continue. So I think it's not a binary event, but I wouldn't necessarily project that we'll knock down one of the larger plans until we have some meaningful clinical utility here.

    但在此期間,我們與二級 PPO 的對話,如 Multiplan 和較小的計劃,將繼續進行。所以我認為這不是一個二元事件,但我不一定會預測我們會推翻一個更大的計劃,直到我們在這裡有一些有意義的臨床效用。

  • Operator

    Operator

  • (Operator Instructions) And our final question comes from Edward Woo from Ascendiant Capital.

    (操作員說明)我們的最後一個問題來自 Ascendiant Capital 的 Edward Woo。

  • Edward Moon Woo - Director of Research and Senior Research Analyst of Internet & Digital Media

    Edward Moon Woo - Director of Research and Senior Research Analyst of Internet & Digital Media

  • 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 productivity and whether there will be room for improvement?

    祝賀這個季度。就您擁有的 40 名銷售人員而言,平均任期是多少?您如何描述生產力以及是否有改進的空間?

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Yes. So that's a great question. I don't have a hard number for you, but we are -- and it's certainly increasing now that we've plateaued the number, probably about 6 to 9 months is, I would say, would be the median. So we have a good median. The median rep has now had a decent time in the field. And 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.

    是的。所以這是一個很好的問題。我沒有給你一個確切的數字,但我們是——而且現在我們已經穩定了這個數字,它肯定在增加,我想說,大概 6 到 9 個月是中位數。所以我們有一個很好的中位數。中位代表現在在該領域度過了一段不錯的時光。正如我在之前的電話會議中提到的那樣,通過穩定我們的團隊,它解放了銷售領導層,讓他們在該領域更加活躍,在戰略客戶中更加活躍。

  • So we closed a large strategic account a couple of weeks ago. That will -- adjust more time with them because they're not spending all the time on interviewing and recruiting. So that 6 to 9-month media number will obviously go up as the year progresses, and 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 experience and hoping that number will go up steadily over the year.

    所以我們幾週前關閉了一個大型戰略賬戶。這將 - 調整更多與他們在一起的時間,因為他們不會一直花在面試和招聘上。因此,隨著時間的推移,6 到 9 個月的媒體數量顯然會增加,我們發現在該領域的時間更多,與醫生互動和與客戶打交道的經驗更多,並試圖讓他們更具粘性。顯然,增加經驗並希望這一數字在這一年中穩步上升。

  • Operator

    Operator

  • And we have no further questions in queue. I'll turn the call back over to our host.

    我們沒有其他問題要排隊了。我會把電話轉回我們的主持人。

  • Lishan Aklog - Chairman & CEO

    Lishan Aklog - Chairman & CEO

  • Great. So 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@pavmed.com for any further questions. So thank you very much.

    偉大的。因此,感謝大家抽出寶貴時間與我們一起度過上午的更新電話會議。我們感謝大家的努力和大家的支持。如有任何其他問題,請隨時與我們聯繫。您可以在我們的網站 luciddx.com 上獲取信息,或通過 mep@pavmed.com 聯繫 Mike Parks 以獲取更多信息。非常感謝。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for attending, and have a pleasant day.

    今天的電話會議到此結束。感謝您的光臨,祝您度過愉快的一天。