Lucid Diagnostics Inc (LUCD) 2022 Q1 法說會逐字稿

Greetings. Welcome to the Lucid Diagnostics business update conference call. (Operator Instructions) And please note that this conference is being recorded.

問候。歡迎來到 Lucid Diagnostics 業務更新電話會議。 （操作員說明）請注意，正在錄製此會議。

I will now turn the conference over to Adrian Miller, Vice President of Investor Relations. Thank you, sir. You may begin.

我現在將會議轉交給投資者關係副總裁 Adrian Miller。謝謝你，先生。你可以開始了。

Thanks, operator. Good afternoon, everyone. This is Adrian Miller, Vice President, Investor Relations at Lucid Diagnostics. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics; along with Dennis McGrath, Chief Financial Officer of Lucid Diagnostics. The press release announcing our business update and financial results is available on Lucid's website. Please take a moment to read the disclaimer about forward-looking statements in the press release.

謝謝，運營商。大家下午好。我是 Lucid Diagnostics 投資者關係副總裁 Adrian Miller。感謝您參與今天的業務更新電話會議。今天和我一起參加電話會議的有 Lucid Diagnostics 董事長兼首席執行官 Lishan Aklog 博士；與 Lucid Diagnostics 首席財務官 Dennis McGrath 一起。宣布我們的業務更新和財務結果的新聞稿可在 Lucid 的網站上找到。請花點時間閱讀新聞稿中有關前瞻性陳述的免責聲明。

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 the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission. For a list and description of these and other important risks and uncertainties that may affect the future operations, see Part I Item 1A entitled Risk Factors in Lucid's most recent annual report on Form 10-K filed with the SEC and the subsequent update filed quarterly reports in Form 10-Q and any subsequent Form 8-K filings.

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的風險和不確定因素的影響，這些風險和不確定性可能導致實際結果與所作陳述存在重大差異。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不同的因素。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表和描述，請參閱 Lucid 最近向美國證券交易委員會提交的 10-K 表格年度報告中題為風險因素的第 I 部分第 1A 項以及隨後提交的更新季度報告在 10-Q 表格和任何後續的 8-K 表格文件中。

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 those expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

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，以反映預期或這些預期可能基於的事件、條件或情況的變化，或可能影響實際結果的可能性將不同於前瞻性陳述中包含的內容。

So with that, I'd like to turn the call over to Lishan Aklog. Dr. Aklog?

因此，我想將電話轉給 Lishan Aklog。阿克洛博士？

Thank you, Adrian, and good afternoon, everyone. I'm happy to report that Lucid Diagnostics is making excellent progress on all fronts, and that we're laying a solid foundation for driving our long-term growth strategy. We continue to drive EsoGuard commercialization, expand our sales infrastructure, execute the second stage of our Lucid Test Center rollout, transition to our own fully staffed laboratory and update our clinical trial strategy to best serve our growth strategy. Our balance sheet remains strong, providing us with the resources to execute this growth strategy. Before proceeding, I'd like to thank our long-term shareholders for your ongoing support and commitment. We are singularly focused on growing Lucid while enhancing long-term shareholder value.

謝謝阿德里安，大家下午好。我很高興地報告，Lucid Diagnostics 在各個方面都取得了出色的進展，並且我們正在為推動我們的長期增長戰略奠定堅實的基礎。我們繼續推動 EsoGuard 商業化，擴大我們的銷售基礎設施，執行我們 Lucid 測試中心推出的第二階段，過渡到我們自己的人員齊全的實驗室，並更新我們的臨床試驗戰略以最好地服務於我們的增長戰略。我們的資產負債表依然強勁，為我們提供了執行這一增長戰略的資源。在繼續之前，我要感謝我們的長期股東一直以來的支持和承諾。我們特別專注於發展 Lucid，同時提高長期股東價值。

I'll start by providing an overview of our business, and then we'll pass the baton over to Dennis, who will provide a financial update before opening it up to questions. Let me first provide some background on our company and its mission. Lucid Diagnostics is a commercial stage cancer prevention diagnostics company focused on the millions of chronic heartburn patients who are at risk of developing highly lethal esophageal cancer. Unlike other common cancers, mortality rates are high, even in their earlier stages, so preventing deaths requires us to detect esophageal precancer, which occurs in approximately 5% to 15% of at-risk chronic heartburn patients.

我將首先概述我們的業務，然後我們將接力棒交給丹尼斯，他將在開放提問之前提供財務更新。首先讓我介紹一下我們公司的背景及其使命。 Lucid Diagnostics 是一家商業階段的癌症預防診斷公司，專注於數百萬有患高致死性食管癌風險的慢性胃灼熱患者。與其他常見癌症不同，死亡率很高，即使在早期階段也是如此，因此預防死亡需要我們檢測食管癌前病變，這種情況發生在大約 5% 到 15% 的高危慢性胃灼熱患者中。

Esophageal precancer can be monitored in its early phase and cured with an endoscopic ablation procedure in its late phase. Ablation reliably halts the progression to esophageal cancer. Although esophageal precancer screening is already recommended in millions of chronic heartburn patients, fewer than 10% undergo traditional invasive endoscopic screening. The profound tragedy of nearly every esophageal cancer diagnosis is that likely death could have been prevented if the patient had been screened.

食管癌前期可以在其早期進行監測，並在其晚期通過內窺鏡消融手術治愈。消融可靠地阻止了食管癌的進展。儘管數百萬慢性胃灼熱患者已經被推薦進行食管癌前病變篩查，但只有不到 10% 的患者接受了傳統的侵入性內窺鏡篩查。幾乎每一個食管癌診斷的深刻悲劇是，如果對患者進行篩查，可能可以避免死亡。

The missing element for a viable early detection program to prevent these thousands of tragic deaths has been the lack of a widespread screening tool. We believe our EsoGuard NGS methylated DNA test performed on samples collected in a brief noninvasive office procedure using our EsoCheck collection device is the first and only commercially available diagnostic test capable of serving such a widespread screening tool. We believe EsoGuard has the potential to become the standard of care to detect esophageal precancer in at-risk chronic heartburn patients with the total addressable market greater than $25 billion.

防止這些數千人悲慘死亡的可行早期檢測計劃缺少的要素是缺乏廣泛的篩查工具。我們相信，我們的 EsoGuard NGS 甲基化 DNA 測試是使用我們的 EsoCheck 收集設備對通過簡短的非侵入性辦公室程序收集的樣本進行的，這是第一個也是唯一一個能夠提供如此廣泛篩查工具的商業診斷測試。我們相信 EsoGuard 有潛力成為檢測高危慢性胃灼熱患者食管癌前病變的標準護理，潛在市場總額超過 250 億美元。

As we previously announced, the American College of Gastroenterology recently updated its clinical guideline on the diagnosis and management of esophageal precancer, the first such update since 2016. The guideline reiterates the long-standing recommendation that chronic heartburn patients should undergo esophageal precancer screening, if they have at least 3 of 6 defined risk factors, which include male sex, age over 50, obesity, smoking and a family history. I would like to highlight 2 key updates that greatly enhance the commercial potential of Lucid products contained in this guideline.

正如我們之前宣布的那樣，美國胃腸病學會最近更新了其關於食管癌前病變診斷和管理的臨床指南，這是自 2016 年以來的首次此類更新。該指南重申了長期以來的建議，即慢性胃灼熱患者應接受食管癌前病變篩查，如果他們至少有 6 個確定的風險因素中的 3 個，包括男性、50 歲以上、肥胖、吸煙和家族史。我想強調 2 個關鍵更新，它們極大地增強了本指南中包含的 Lucid 產品的商業潛力。

First, the guideline no longer hedges on recommending screening for women. This more than doubles the target population for EsoGuard testing to an estimated 30 million Americans. Second and most importantly, for the first time, the guideline endorses non-endoscopic biomarker screening as an acceptable alternative to costly and invasive endoscopy. EsoGuard and EsoCheck, which are described in the guidelines, are currently the only such non-endoscopic biomarker screening test. This is an exciting development for Lucid, and I can't overemphasize its importance in supporting our efforts to eradicate esophageal cancer. We look and expect other -- we look forward for other professional guidelines to follow suit.

首先，該指南不再對推薦女性進行篩查進行對沖。這使 EsoGuard 測試的目標人群增加了一倍多，估計有 3000 萬美國人。其次也是最重要的是，該指南首次認可非內窺鏡生物標誌物篩查作為昂貴和侵入性內窺鏡檢查的可接受替代方案。指南中描述的 EsoGuard 和 EsoCheck 是目前唯一的此類非內窺鏡生物標誌物篩選測試。這對 Lucid 來說是一個令人興奮的發展，我不能過分強調它在支持我們根除食道癌的努力中的重要性。我們期待並期待其他——我們期待其他專業指南也能效仿。

Let's now review how EsoGuard commercialization has been going. We continue to see excellent traction with robust growth in EsoGuard testing volume. We processed 533 commercial EsoGuard tests in the first quarter of 2022. That represents a 76% sequential increase from the fourth quarter of 2021 and a nearly 500% increase annually from the first quarter of 2021. Testing volume growth was strong in both sales channels, primary care physician referrals for our Lucid test centers as well as tests performed by gastroenterology and foregut surgeon specialty practices and institutions.

現在讓我們回顧一下 EsoGuard 商業化的進展情況。隨著 EsoGuard 測試量的強勁增長，我們繼續看到出色的牽引力。我們在 2022 年第一季度處理了 533 項商業 EsoGuard 測試。這比 2021 年第四季度環比增長 76%，比 2021 年第一季度每年增長近 500%。兩個銷售渠道的測試量增長強勁，我們的 Lucid 測試中心的初級保健醫生轉介以及胃腸病學和前腸外科醫生專業實踐和機構進行的測試。

Now that our sales process and sales training is well honed and increasingly predictable, our near-term growth strategy is clearly defined. We are investing in sales infrastructure, training and supporting resources sufficient to drive steady testing volume growth to demonstrate clinical utility and generate claims history to support our reimbursement efforts. One reimbursement -- once reimbursement is more fully established, we will transition to full-throttle efforts to drive testing volume and revenue growth. Our sales team consists of market development managers who focus on establishing EsoGuard testing at gastroenterology, foregut surgeon, large primary care and multi-specialty practices as well as large academic medical centers and integrated health networks.

既然我們的銷售流程和銷售培訓得到了很好的磨練並且越來越可預測，我們的近期增長戰略也已明確定義。我們正在投資銷售基礎設施、培訓和支持資源，以推動穩定的測試量增長，以證明臨床效用並生成索賠歷史記錄，以支持我們的報銷工作。一次報銷——一旦報銷更充分地建立起來，我們將過渡到全力以赴推動測試量和收入增長。我們的銷售團隊由市場開發經理組成，他們專注於在胃腸病學、前腸外科醫生、大型初級保健和多專業實踐以及大型學術醫療中心和綜合健康網絡中建立 EsoGuard 測試。

Our sales reps are focused on engaging with primary care physicians, including those within the referral networks of our gastroenterology and foregut surgeon practices. The team, led by our National VP of Sales, now consists of 3 area directors, covering the East, Central and West, respectively; 6 market development managers; 17 sales reps and several sales operations staff. We are hitting our hiring targets and are actually a bit ahead of schedule to hit our end of year goals. Our sales training process is continuing to be developed and is well honed and quite intense. Our goal is to have new reps operating effectively within about 4 months of hire.

我們的銷售代表專注於與初級保健醫生接觸，包括我們胃腸病學和前腸外科醫生診所轉診網絡內的醫生。該團隊由我們的全國銷售副總裁領導，現在由 3 名區域總監組成，分別負責東部、中部和西部； 6名市場開發經理； 17 名銷售代表和數名銷售運營人員。我們正在實現我們的招聘目標，實際上比我們的年終目標提前了一點。我們的銷售培訓過程正在繼續發展，並且經過精心磨練並且非常激烈。我們的目標是讓新代表在聘用後大約 4 個月內有效運作。

Pillar of our growth strategy remains our expanding network of Lucid Test Centers. The test centers operate in leased medical office suites, each staffed by a Lucid employed EsoCheck trained nurse practitioner or medical assistant. The center support our primary care physician sales channel by providing a facility where a patient referred for EsoGuard testing can undergo the EsoCheck cell collection procedure. The reps work to educate the primary care physicians on the relationship between chronic heartburn and esophageal cancer and on EsoGuard's availability as a new noninvasive alternative to screen at-risk patients. The physician then just orders a test, which is performed at one of our test centers.

我們增長戰略的支柱仍然是我們不斷擴大的 Lucid 測試中心網絡。測試中心在租用的醫療辦公室套房內運作，每個辦公室都配備了一名受過 EsoCheck 培訓的 Lucid 執業護士或醫療助理。該中心通過提供一個設施來支持我們的初級保健醫生銷售渠道，轉介進行 EsoGuard 測試的患者可以在該設施中進行 EsoCheck 細胞採集程序。代表們致力於就慢性胃灼熱和食道癌之間的關係以及 EsoGuard 作為篩查高危患者的一種新的無創替代方法對初級保健醫生進行教育。然後，醫生會下令進行一項測試，該測試將在我們的一個測試中心進行。

Single nurse practitioner can reasonably perform 20 EsoCheck procedures in a normal workday. Each test center covers its personal and medical office lease costs with only a couple of reimbursements per week. The Lucid Test Center program completed its first stage during the first quarter of 2022, having advanced for a pilot program in Phoenix launched in the third quarter of 2021. The program has developed into a regional program, covering 7 metropolitan areas in Western states.

一名執業護士在一個正常工作日內可以合理地執行 20 次 EsoCheck 程序。每個測試中心都支付其個人和醫療辦公室租賃費用，每週僅報銷幾次。 Lucid 測試中心計劃於 2022 年第一季度完成第一階段，並已推進到 2021 年第三季度在鳳凰城啟動的試點計劃。該計劃已發展為區域計劃，覆蓋西部各州的 7 個大都市地區。

We recently launched Stage 2 of our Lucid Test Center program. We plan to open test centers in 9 additional states this year. And last month, we hired a Director of Clinical Services with extensive experience operating dialysis facilities for Fresenius and DaVita to oversee this expansion. We continue to pilot our EsoGuard telemedicine program, which we launched in December. Patients who learn about EsoGuard testing can request an online visit with the telemedicine physician who can send the patient if appropriate to a Lucid Test Center for EsoGuard testing.

我們最近啟動了 Lucid 測試中心計劃的第二階段。我們計劃今年在另外 9 個州開設考試中心。上個月，我們聘請了一位在 Fresenius 和 DaVita 透析設施運營方面擁有豐富經驗的臨床服務總監來監督此次擴張。我們繼續試行我們於 12 月推出的 EsoGuard 遠程醫療計劃。了解 EsoGuard 測試的患者可以請求與遠程醫療醫生進行在線訪問，如果合適，他們可以將患者送到 Lucid 測試中心進行 EsoGuard 測試。

Although patients at any Lucid Test Center city can access the telemedicine program, we continue to only actively pursue direct-to-consumer advertising on a limited pilot basis in Phoenix, consistent with the near-term strategy I previously described. We're just over 4 months into the program, and we'll soon have sufficient numbers to assess the efficacy of various modes of direct-to-consumer engagement. I'd like to now discuss our laboratory operations. The first quarter and recent months have been full of important developments in our laboratory operations, which are critical to the future success of the company. At the end of February, LucidDx Labs, a wholly owned subsidiary of Lucid Diagnostics, acquired the assets necessary to operate its own -- our own CLIA-certified, CAP-accredited clinical laboratory.

儘管任何 Lucid 測試中心城市的患者都可以使用遠程醫療計劃，但我們繼續只在鳳凰城的有限試點基礎上積極尋求直接面向消費者的廣告，這與我之前描述的近期戰略一致。我們剛剛進入該計劃 4 個多月，我們很快就會有足夠的數字來評估各種直接面向消費者的參與模式的有效性。我現在想談談我們的實驗室運作。第一季度和最近幾個月我們的實驗室運營取得了重大進展，這對公司未來的成功至關重要。 2 月底，Lucid Diagnostics 的全資子公司 LucidDx Labs 收購了運營自己的必要資產——我們自己的 CLIA 認證、CAP 認證的臨床實驗室。

The laboratory operates in a freestanding 20,000 square foot building in Orange County, California. And last month, we hired a new VP of Laboratory Operations with nearly 2 decades of clinical laboratory experience, including at LabCorp, Abbott and Rosetta Genomics. Under his and our Chief Scientific Officer's leadership, we plan to accelerate the transition from the current management services agreement to the lab being fully staffed by Lucid employees. In parallel with the acquisition, we upgraded our revenue cycle management provider to SYNERGEN Solutions.

該實驗室在加利福尼亞州奧蘭治縣一座佔地 20,000 平方英尺的獨立建築內運營。上個月，我們聘請了一位新的實驗室運營副總裁，他在 LabCorp、Abbott 和 Rosetta Genomics 擁有近 20 年的臨床實驗室經驗。在他和我們的首席科學官的領導下，我們計劃加快從當前的管理服務協議向 Lucid 員工配備齊全的實驗室的過渡。在收購的同時，我們將收入周期管理提供商升級為 SYNERGEN Solutions。

SYNERGEN will be up and running this month and will begin billing and processing claims on behalf of LucidDx Labs. This will be the first time a Lucid entity will be billing directly for EsoGuard test. Claims held since the lab transition in February will be submitted once SYNERGEN is active later this month. The transition from fixed monthly payments from our former laboratory partner to direct billing will result in a temporary pause of out-of-network receipts and recognized revenue as Dennis will describe in more detail.

SYNERGEN 將於本月啟動並運行，並將代表 LucidDx Labs 開始計費和處理索賠。這將是 Lucid 實體首次直接為 EsoGuard 測試計費。一旦 SYNERGEN 在本月晚些時候激活，將提交自 2 月實驗室過渡以來持有的索賠。從我們以前的實驗室合作夥伴的每月固定付款到直接計費的過渡將導致網絡外收據和確認收入的暫停，正如丹尼斯將更詳細地描述的那樣。

Now a brief update on where we stand with reimbursement. On the private payer side, we were pleased to announce earlier this week that we executed our first commercial payer agreement. LucidDx Labs entered into a participating provider agreement with MediNcrease Health Plans, LLC, a national, directly contracted multi-specialty PPO provider network with over 8 million lives covered through its clients and payers. Persons covered by Medicare -- by MediNcrease clients and payers will have in-network access to EsoGuard testing. The agreement provides rates of reimbursement as a percent of charges for services rendered, including performance of the EsoGuard test.

現在簡要介紹一下我們在報銷方面的立場。在私人付款人方面，我們很高興在本週早些時候宣布我們執行了第一份商業付款人協議。 LucidDx Labs 與 MediNcrease Health Plans , LLC 簽訂了參與供應商協議， MediNcrease Health Plans , LLC 是一個全國性的、直接簽約的多專業 PPO 供應商網絡，其客戶和付款人覆蓋了超過 800 萬人的生命。 Medicare 覆蓋的人——MediNcrease 的客戶和付款人將可以在網絡內訪問 EsoGuard 測試。該協議規定報銷率佔所提供服務費用的百分比，包括執行 EsoGuard 測試。

We are pleased that the effective payment for EsoGuard under this agreement, which is based on a list price of approximately $2,500, is consistent with our goal of protecting the effect of Medicare payment of just over $1,900. We will work -- continue to work tirelessly to secure many more such participating provider agreements covering millions of more lives in the coming quarters. In parallel, we continue to collect critical clinical utility data, demonstrating that EsoGuard positively impacts patient care. Such data will be necessary for us to secure a directed network coverage for major regional and national health plans.

我們很高興根據本協議對 EsoGuard 的有效付款（基於約 2,500 美元的標價）與我們保護 Medicare 支付效果的目標一致，即超過 1,900 美元。我們將努力——繼續不懈努力，爭取在未來幾個季度獲得更多此類參與供應商協議，覆蓋更多數百萬人的生命。與此同時，我們繼續收集關鍵的臨床實用數據，證明 EsoGuard 對患者護理產生積極影響。這些數據對於我們確保主要區域和國家衛生計劃的定向網絡覆蓋是必要的。

We've also seen progress on the Medicare reimbursement front. Last month, Medicare contractor, Palmetto GBA's MolDx Program published a proposed Local Coverage Determination, or LCD, for tests designed to detect upper gastrointestinal precancer and cancer. Consistent with its practice over the past couple of years, the proposed LCD is a foundational LCD. That means it provides criteria for a category of testing, not a specific test. Proposed LCDs are by definition works in progress for public review. We have been patiently awaiting this important next step in the process since we completed CMS' Clinical Laboratory Fee Schedule or CLFS process, culminating in the important first step, namely final Medicare payment determination, which became effective on January 1, 2021.

我們還看到了醫療保險報銷方面的進展。上個月，Medicare 承包商 Palmetto GBA 的 MolDx 計劃發布了一項擬議的局部覆蓋測定 (Local Coverage Determination, LCD)，用於旨在檢測上消化道癌前病變和癌症的測試。與過去幾年的實踐一致，擬議的 LCD 是基礎 LCD。這意味著它提供了測試類別的標準，而不是特定測試。根據定義，擬議的 LCD 正在進行中以供公眾審查。自我們完成 CMS 的臨床實驗室費用表或 CLFS 流程以來，我們一直在耐心等待這一重要的下一步，最終邁出了重要的第一步，即最終的 Medicare 付款決定，該決定於 2021 年 1 月 1 日生效。

The proposed LCD outlines criteria that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic test to meet. These criteria include active GERD with at least 2 risk factors, as well as evidence of analytic validity, clinical validity and clinical utility. Although it found that no currently existing test has fulfilled these criteria, it indicated that it will monitor the evidence and will provide coverage based on the pertinent literature and society recommendations. It's important to emphasize that the provisional LCD was published prior to the publication of the update of the ACG guideline and as such does not take into consideration the recommendation supporting non-endoscopic biomarker testing such as EsoGuard as an acceptable alternative to endoscopy for esophageal precancer screening.

擬議的 LCD 概述了 MolDX 期望上消化道癌前病變和癌症分子診斷測試能夠滿足的標準。這些標準包括具有至少 2 個危險因素的活動性 GERD，以及分析有效性、臨床有效性和臨床實用性的證據。儘管它發現目前沒有任何測試滿足這些標準，但它表示它將監控證據並將根據相關文獻和社會建議提供覆蓋範圍。需要強調的是，臨時 LCD 是在 ACG 指南更新發布之前發布的，因此沒有考慮支持非內窺鏡生物標誌物測試（例如 EsoGuard）作為食管癌前病變篩查內窺鏡檢查的可接受替代方案的建議.

The publication of the proposed LCD triggered a written comment period that extends until this Saturday. We, along with multiple other stakeholders, will be submitting comments suggesting important modifications to the proposed LCD. MolDX also held a substantive open meeting yesterday, during which we, along with other stakeholders and interested parties, had the opportunity to address the proposed LCD. We previewed our suggested modifications to the proposed LCD. Subsequently, Dr. David Poppers of NYU, who has performed hundreds of EsoGuard tests, discussed the clinical utility of EsoGuard testing in his practice. And finally, Mindy Mordecai, Founder of the Esophageal Cancer Action Network and a widow of an esophageal cancer victim, offered a moving and passion statement on how critical non-endoscopic biomarker testing is to prevent esophageal cancer deaths.

擬議 LCD 的發布觸發了一個延長至本週六的書面評論期。我們將與其他多個利益相關者一起提交意見，建議對擬議的 LCD 進行重要修改。 MolDX 昨天還舉行了實質性公開會議，在此期間，我們與其他利益相關者和感興趣的各方一起，有機會討論擬議的 LCD。我們預覽了我們對提議的 LCD 的建議修改。隨後，進行了數百次 EsoGuard 測試的紐約大學 David Poppers 博士在他的實踐中討論了 EsoGuard 測試的臨床實用性。最後，食管癌行動網絡的創始人兼食管癌受害者的遺孀 Mindy Mordecai 就非內窺鏡生物標誌物檢測對於預防食管癌死亡的重要性發表了感人且充滿激情的聲明。

In addition, we recently learned that Noridian Healthcare Solutions, the Medicare contractor, which covers LucidDx Labs in California and participates in the MolDX program, has scheduled its own open meeting on May 26 and a written comment period that extends through June 11. We look forward to the opportunity to address the proposed LCD directly with Noridian as well. A final LCD will not be issued until the Medicare administrative contractors have had the opportunity to assess and consider the comments written and of comments during the public meetings.

此外，我們最近了解到，涵蓋加利福尼亞州 LucidDx Labs 並參與 MolDX 計劃的 Medicare 承包商 Noridian Healthcare Solutions 已安排在 5 月 26 日舉行自己的公開會議，並將書面評論期延長至 6 月 11 日。我們看期待有機會直接與 Noridian 討論擬議的 LCD。在 Medicare 行政承包商有機會評估和考慮公開會議期間的書面評論和評論之前，不會發布最終的 LCD。

Let's now wrap up with our clinical studies. As I said on many occasions, expanding into clinical evidence for EsoGuard testing is a pillar of our growth strategy and was the key impedence for us raising capital in the fall. Over the past couple of months, our management team, along with our Board, have been reviewing our clinical trial strategy to make sure that the substantial capital we are investing in clinical trials is being deployed in an optimal fashion, consistent with our short- and long-term strategic goals and situation on the ground.

現在讓我們結束我們的臨床研究。正如我在很多場合所說，擴展 EsoGuard 測試的臨床證據是我們增長戰略的支柱，也是我們在秋季籌集資金的主要障礙。在過去的幾個月裡，我們的管理團隊和董事會一直在審查我們的臨床試驗戰略，以確保我們投資於臨床試驗的大量資金以最佳方式部署，符合我們的短期和短期目標。長期戰略目標和實際情況。

There are numerous factors we're considering in addition to optimal capital utilization. These include our current understanding from the trenches of what drives clinical adoption, the rapidly evolving reimbursement landscape I just described, promising research data on the kind of next-generation version of the EsoGuard assay and the opportunity to conform the clinical trial processes to current clinical practice. We expect this updated clinical strategy to be finalized in the coming months.

除了優化資本利用之外，我們還在考慮許多因素。這些包括我們目前對推動臨床採用的因素的理解、我剛才描述的快速發展的報銷情況、關於下一代 EsoGuard 檢測的有前途的研究數據以及使臨床試驗過程符合當前臨床的機會實踐。我們預計這一更新的臨床策略將在未來幾個月內完成。

One key aspect of our updated strategy is already underway. We are doubling down on our efforts to generate clinical utility data to support commercial and Medicare reimbursement. Clinical utility trials are designed to demonstrate that EsoGuard impacts medical decision-making. We have multiple such studies, which we expect to launch in the coming weeks, including a retrospective review of Dr. Popper's NYU experience, focused on the impact of EsoGuard on medical decision-making. Additionally, multiple prospective clinical utility studies, including a Lucid sponsored registry at existing commercial sites, a prospective Lucid sponsored clinical utility study named CLUE, C-L-U-E, and prospective clinical utility studies that are institutionally sponsored at Northwell Health and at St. Joseph's Health, New Jersey.

我們更新戰略的一個關鍵方面已經在進行中。我們正在加倍努力生成臨床效用數據以支持商業和醫療保險報銷。臨床效用試驗旨在證明 EsoGuard 影響醫療決策。我們有多項此類研究，預計將在未來幾週內啟動，包括對 Popper 博士在紐約大學的經歷進行回顧性審查，重點關注 EsoGuard 對醫療決策的影響。此外，多項前瞻性臨床效用研究，包括現有商業網站上的 Lucid 贊助註冊、名為 CLUE、C-L-U-E 的前瞻性 Lucid 贊助臨床效用研究，以及由 Northwell Health 和 St. Joseph's Health、New球衣。

With that, I'll pass the baton over to Dennis to provide an update on our financials before opening up for questions.

有了這個，我會把接力棒交給丹尼斯，在開始提問之前提供我們財務的最新情況。

Thanks, Lishan, and good afternoon, everyone. Our preliminary and summary financial results for the first quarter ended March 31, 2022, were reported in our press release that was published earlier today. We plan to file our annual -- our quarterly report for Lucid Diagnostics on Form 10-Q with the SEC on May 16, the due date. At that time, it will be available at sec.gov and on the Lucid website. As you already know from our previous quarterly corporate update calls that, as a rule, EsoGuard test performed are recognized as GAAP revenue when cash is collected by the company. Also, as previously mentioned, this more than likely will be true during this transition period of negotiating third-party private payer reimbursement contracts and related coverage policies.

謝謝，李山，大家下午好。我們在今天早些時候發布的新聞稿中報告了我們截至 2022 年 3 月 31 日的第一季度的初步和摘要財務業績。我們計劃在截止日期 5 月 16 日向 SEC 提交 10-Q 表格中 Lucid Diagnostics 的年度報告和季度報告。屆時，它將在 sec.gov 和 Lucid 網站上提供。正如您從我們之前的季度公司更新電話會議中了解到的那樣，通常情況下，執行的 EsoGuard 測試在公司收取現金時被確認為 GAAP 收入。此外，如前所述，在談判第三方私人付款人報銷合同和相關保險政策的過渡期間，這很可能會成為現實。

As I reported to you in previous quarters, the compliance purposes during this reimbursement transition period, we negotiated a short-term month-to-month fixed payment arrangement with the contract laboratory that was processing the EsoGuard assay and was performing the insurance company billing and collections function. This commercial agreement became effective on August 1, 2021, and terminated concurrently with the opening of our own lab on February 25, just a couple weeks back. We recognized $189,000 of revenue as part of the EsoGuard commercial agreement with ResearchDx for the partial period from January 1, 2022, through the end of the agreement on February 25.

正如我在前幾個季度向您報告的那樣，在這個報銷過渡期間的合規目的，我們與處理 EsoGuard 分析並執行保險公司計費的合同實驗室協商了一項短期的每月固定付款安排收藏功能。該商業協議於 2021 年 8 月 1 日生效，並在幾週前的 2 月 25 日我們自己的實驗室開幕時同時終止。作為與 ResearchDx 簽訂的 EsoGuard 商業協議的一部分，我們確認了從 2022 年 1 月 1 日到協議於 2 月 25 日結束的部分期間的 189,000 美元收入。

Now that we are operating our own laboratory during -- following the February asset purchase agreement, we will be able to directly bill payers. As Lishan described, direct billing will occur in the second quarter once our new revenue cycle provider comes online. Future revenues will be recognized based upon actual collections until such time as the coverage policies are in place with CMS and payment contracts with the private payers. This obviously can result in timing of revenues recognized versus timing they are submitted for third-party reimbursement until these future conditions are met.

現在我們在 2 月份的資產購買協議之後運營我們自己的實驗室，我們將能夠直接向付款人開具賬單。正如 Lishan 所描述的，一旦我們新的收入周期提供商上線，直接計費將在第二季度發生。未來的收入將根據實際收款確認，直到 CMS 的覆蓋政策和與私人付款人的付款合同到位。這顯然會導致確認收入的時間與提交第三方報銷的時間不同，直到滿足這些未來條件。

The gap in claim submission from this transition will impact near-term GAAP revenue recognized until the system catches up with claims for test performed during the transition. The number of EsoGuard test performed and submitted for payment are provided in the press release and was discussed earlier by Lishan. Obviously, we're in the early stages of our commercial launch, particularly with our test centers. We'll continue to evolve our reporting metrics as various sales and marketing efforts further influence adoption, particularly with the ramp-up of our Lucid Test Centers and our EsoGuard telemedicine program in cooperation with UpScript.

此過渡期間索賠提交的差距將影響確認的近期 GAAP 收入，直到系統趕上過渡期間執行的測試索賠。新聞稿中提供了執行和提交付款的 EsoGuard 測試的數量，李山早些時候也討論過。顯然，我們正處於商業發布的早期階段，尤其是我們的測試中心。隨著各種銷售和營銷工作進一步影響採用，我們將繼續改進我們的報告指標，特別是隨著我們的 Lucid 測試中心和我們與 UpScript 合作的 EsoGuard 遠程醫療計劃的擴大。

Presently, there are 5 banking analysts who have issued coverage on Lucid and others doing their diligence. The quantity of EsoGuard test payable at the CMS payment rate required to meet the 2022 revenue estimates provided by the analysts are achievable. The quantity and collections -- of collections are highly dependent upon the evolving reimbursement landscape. With regard to revenue, Lucid recognized approximately $200,000 of revenues related to EsoGuard for the quarter ended March 31. Despite the negative gross profit for this period, which reflects the initial test center start-up-related costs at modest volumes, incremental gross margins continued to be around 90% and contribution margins can be north of 60%. These lower test volume amounts have a minimum level of fixed costs associated with just being operational.

目前，有 5 位銀行業分析師對 Lucid 和其他人的盡職調查發表了報導。按照分析師提供的 2022 年收入估計所需的 CMS 支付率，EsoGuard 測試的應付數量是可以實現的。收款的數量和收款情況在很大程度上取決於不斷變化的報銷情況。在收入方面，Lucid 在截至 3 月 31 日的季度確認了約 200,000 美元與 EsoGuard 相關的收入。儘管這一時期的毛利潤為負，這反映了初始測試中心啟動相關成本適中，但毛利率仍在增加達到 90% 左右，貢獻利潤率可以超過 60%。這些較低的測試量具有與運行相關的最低水平的固定成本。

Now a few comments about operating expenses, sales and marketing to start. For the quarter ended March 2022, sales and marketing expenses were approximately $3.3 million for the quarter compared to $700,000 for the corresponding prior year, reflects about -- and also reflects an increase of about 12% sequentially, not including stock-based compensation charges. This largely reflects head count increases and related costs.

現在開始談談關於運營費用、銷售和營銷的一些評論。截至 2022 年 3 月的季度，本季度的銷售和營銷費用約為 330 萬美元，而去年同期為 700,000 美元，反映了約 - 並且還反映了約 12% 的環比增長，不包括基於股票的補償費用。這在很大程度上反映了員工人數的增加和相關成本。

On the G&A front. G&A expenses were $5.7 million for the quarter ended March 31 compared with $1.2 million for the corresponding period last year and approximately a 13% increase sequentially. The increases are largely related to compensation and other outside consulting services related to patents, regulatory compliance, legal costs and public company expenses. R&D expenses for the quarter just ended were approximately $2.9 million as compared to $1.8 million for the corresponding period last year and are slightly lower sequentially with the changes between the periods largely tied to clinical trial expenses.

在 G&A 方面。截至 3 月 31 日的季度，一般及行政費用為 570 萬美元，去年同期為 120 萬美元，環比增長約 13%。增長主要與薪酬和與專利、監管合規、法律費用和上市公司費用相關的其他外部諮詢服務有關。剛剛結束的這個季度的研發費用約為 290 萬美元，而去年同期為 180 萬美元，環比略有下降，主要與臨床試驗費用有關。

There's a table we provide in the press release published earlier that adjusts each of these components of operating expenses for the embedded noncash stock-based compensation expense. Without the stock-based compensation expense, total operating expenses for Lucid were $8.1 million compared to $2.9 million for the 3 months ended March 31 and '21, respectively.

我們在早些時候發布的新聞稿中提供了一張表格，該表格針對嵌入式非現金股票補償費用調整了運營費用的每個組成部分。不包括基於股票的補償費用，Lucid 的總運營費用為 810 萬美元，而截至 3 月 31 日和 21 年的三個月分別為 290 萬美元。

With respect to the loss per share amounts, Lucid Diagnostics reported a first quarter 2022 net loss attributable to common stockholders of $12.3 million or a loss of $0.35 per common share versus the same period in the prior year of a loss of $3.7 million or $0.26 per share. The press release also provides a table entitled Non-GAAP, which highlights these amounts along with noncash charges, namely depreciation, stock-based compensation, acquisition-related costs, all to enable a better understanding of the company's financial performance.

關於每股虧損金額，Lucid Diagnostics 報告稱，2022 年第一季度歸屬於普通股股東的淨虧損為 1230 萬美元或每股普通股虧損 0.35 美元，而去年同期為虧損 370 萬美元或每股虧損 0.26 美元分享。新聞稿還提供了一個名為非 GAAP 的表格，其中突出顯示了這些金額以及非現金費用，即折舊、基於股票的薪酬、與收購相關的成本，所有這些都是為了更好地了解公司的財務業績。

You'll notice from the table after adjusting the first quarter GAAP loss by approximately $4 million for noncash charges, the company reported a non-GAAP adjusted loss for the first quarter of $8.2 million or $0.23 per common share. Lucid had cash of $47.9 million as of March 31. That compares to $53.7 million at December 31. As you're aware from our last call, Lucid entered into a committed equity facility with an affiliate of Cantor Fitzgerald, where Cantor committed to purchase up to $50 million of the company's common stock from time to time at the request of the company. Any future funding from this facility is completely at the discretion of the company and, if utilized, likely would extend the company's runway well into 2024.

您會從表中註意到，在將第一季度 GAAP 虧損因非現金費用調整約 400 萬美元後，該公司報告第一季度非 GAAP 調整虧損為 820 萬美元或每股普通股 0.23 美元。截至 3 月 31 日，Lucid 的現金為 4790 萬美元。相比之下，12 月 31 日為 5370 萬美元。正如您從我們上次電話會議中了解到的那樣，Lucid 與 Cantor Fitzgerald 的附屬公司簽訂了承諾股權融資協議，Cantor 承諾收購應公司要求，不時購買公司普通股至 5000 萬美元。該設施未來的任何資金完全由公司自行決定，如果使用，很可能會將公司的跑道延長到 2024 年。

Unlike PAVmed, Lucid is not eligible to put a shelf registration action until after November 2022 or more than 12 months after the IPO. Like we described about the PAVmed shelf, the Board considers having available financing options part of their governance duties, even if utilization would finance us well into 2024. So they consider it part of their duties to understand what the long-term opportunities of the company are, and this gives us that vehicle short of being able to put a shelf in place. There were no issuances of stock under this vehicle so far.

與 PAVmed 不同，Lucid 直到 2022 年 11 月之後或 IPO 超過 12 個月後才有資格採取貨架註冊行動。就像我們對 PAVmed 貨架的描述一樣，董事會認為提供可用的融資選擇是他們治理職責的一部分，即使利用這些選項可以為我們提供足夠的資金到 2024 年。因此，他們認為了解公司的長期機會是什麼是他們的職責是，這使我們無法將架子放在適當的位置。到目前為止，該工具下沒有發行股票。

With that, operator, let's open it up to questions.

有了這個，接線員，讓我們開始提問。

(Operator Instructions) Our first question comes from the line of Ross Osborn with Cantor Fitzgerald.

（操作員說明）我們的第一個問題來自 Ross Osborn 和 Cantor Fitzgerald 的台詞。

Congrats on the progress. Just starting off here, I'd love to hear what you're seeing the operating environment. Are you seeing any lingering headwinds that are still limiting growth at this point?

祝賀進步。從這裡開始，我很想听聽您對操作環境的看法。您是否看到任何揮之不去的逆風仍在限制增長？

I see you're referring to kind of macro issues like COVID and such?

我看到你指的是像 COVID 之類的宏觀問題？

Yes.

是的。

Yes. I think we're -- yes, look, I think with the lifting of various restrictions and so forth, it's really no longer a significant issue, as I've emphasized, in the past because we're entirely outpatient based. The sort of challenges associated with inpatient access are just something we don't deal with. So we're in good shape there.

是的。我認為我們 - 是的，看，我認為隨著各種限制的取消等等，這真的不再是一個重要問題，正如我強調的那樣，在過去，因為我們完全是門診病人。與住院患者相關的挑戰只是我們不處理的事情。所以我們在那裡的狀態很好。

Okay. Great. And then could you provide a little more detail of where you stand in the commercialization process with regards to the Phase 2 of your plan?

好的。偉大的。然後，您能否提供更多關於您在計劃第 2 階段的商業化過程中所處的位置的詳細信息？

You mean with regard to the test centers?

你的意思是關於考試中心？

Yes.

是的。

Yes. Right. So we are -- as we said, we announced the launch of the second stage. We've identified 9 locations in 9 metropolitan areas in the -- across the country. And these include larger states, such as California, Texas, Florida and New York, and Ohio and Illinois. And we are in the process of doing what we do to open these centers, identifying geography, looking at various factors that impact that proximity to health facilities and primary care practices, other demographic criteria. We are hiring -- in the process of hiring and have hired sales reps in these areas.

是的。正確的。所以我們 - 正如我們所說，我們宣布啟動第二階段。我們已經在全國的 9 個大都市地區確定了 9 個地點。其中包括較大的州，例如加利福尼亞州、德克薩斯州、佛羅里達州和紐約州，以及俄亥俄州和伊利諾伊州。我們正在做我們所做的事情來開設這些中心，確定地理位置，研究影響與衛生設施和初級保健實踐的接近程度的各種因素，以及其他人口統計標準。我們正在招聘——正在招聘中，並且已經聘請了這些領域的銷售代表。

I think I noted last -- during our last call that actually in several of these states, for example, in Ohio and in Southern California, we actually already have a presence with market development managers and supporting reps who've been calling on gastroenterologists. So it's a little bit different, a little bit of a lower hurdle than in some of the states where we were coming in fresh during the first stage. So making solid progress at identifying locations and hiring nurse practitioners and sales reps, and we look forward to starting to bring these cities online very soon.

我想我最後注意到了——在我們上次電話會議期間，實際上在其中幾個州，例如俄亥俄州和南加州，我們實際上已經與市場開發經理和支持代表聯繫，他們一直在拜訪胃腸病學家。所以它有點不同，比我們在第一階段剛進入的一些州的門檻要低一些。因此，在確定地點和聘請執業護士和銷售代表方面取得了堅實的進展，我們期待很快開始讓這些城市上線。

Okay. Great. And then last one for me. Regarding the ACG update, I realize it's only been a month, but have you seen any acceleration in testing volumes since that went out or at least interest?

好的。偉大的。然後最後一個給我。關於 ACG 更新，我知道這只是一個月，但自從發布後您是否看到測試量有任何加速或至少感興趣？

Yes. I don't -- we never -- I think I've said this before, so I'll reemphasize that our interactions with clinicians in the field has been relatively straightforward in terms of making the case based on the existing data and the -- actually the existing ACG guidelines. So it's not like there was this big gap that we were trying to fill with these updated guidelines. And so -- and that's not to, in any way, understate the importance of EsoGuard and EsoCheck being explicitly mentioned and literally a photograph of the EsoCheck device in the guideline and the fact that the guideline really addresses us as the only existing test that serves as a non-endoscopic biomarker screening test.

是的。我沒有——我們從來沒有——我想我以前說過，所以我要再次強調，我們與該領域臨床醫生的互動在根據現有數據和 - - 實際上是現有的二次元指南。因此，我們試圖用這些更新後的指南來填補這一巨大差距並沒有什麼意義。因此 - 無論如何，這並不是要低估指南中明確提及 EsoGuard 和 EsoCheck 的重要性，以及指南中 EsoCheck 設備的照片以及指南真正將我們視為唯一可用的現有測試的事實作為非內窺鏡生物標誌物篩選測試。

But the greatest impact from the guideline is certainly going to be around reimbursement. As I mentioned in my comments, the proposed LCD specifically references the importance of guidelines and making final coverage determinations and preceded the publication of this guideline. And also what are private payer engagements, the updated and more specific guidelines are extremely important. So will it have some effect as a tool in our armamentarium as we talk to GIs and to primary care physicians? Sure. But it's not like we've been struggling to get that message across without it -- with the prior guidelines.

但該指南的最大影響肯定是在報銷方面。正如我在評論中提到的，擬議的 LCD 特別提到了指南的重要性，並在本指南發布之前做出了最終的覆蓋範圍決定。還有什麼是私人付款人參與，更新和更具體的指南非常重要。那麼，當我們與 GI 和初級保健醫生交談時，它作為我們軍械庫中的一種工具會產生一些影響嗎？當然。但這並不是說我們在沒有它的情況下一直在努力傳達這一信息——按照先前的指導方針。

Okay. Go it. Congrats again.

好的。去吧。再次恭喜。

And our next question comes from the line of Mike Matson with Needham & Company.

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

This is Joseph on for Mike. A quick question around, I guess, Phase II -- yes, in terms of Phase II for the launch of the 9 additional sites, is this, I guess, a full launch in 2022? You have 9 additional sites that will be up and running and completing EsoGuard test. I guess part 2 to that, is there a certain cadence that you guys are expecting? Or is this going to be kind of 1 lump sum of site additions as we saw in Phase I?

這是邁克的約瑟夫。一個簡短的問題，我想，第二階段——是的，就啟動另外 9 個站點的第二階段而言，我想這是在 2022 年全面啟動嗎？您還有 9 個站點將啟動並運行並完成 EsoGuard 測試。我猜第 2 部分，是否有你們期待的特定節奏？或者這是否會像我們在第一階段看到的那樣一次性增加站點？

Yes. Great. Thanks for the question. Yes. This definitely is a 2022 plan. So our goal and our ramp-up with regard to sales reps that will be driving cases to these test centers is consistent with a ramp culminating in the fourth quarter of this year. And the cadence is we're moving forward on all 9 simultaneously. In some locations, it's easier to add -- to identify and hire these practitioners and reps than others. So this is a multi -- this is a parallel path across all 9 states simultaneously in contrast to what we did in Stage 1, where we started with Phoenix, then we did 3, and then we did another 3.

是的。偉大的。謝謝你的問題。是的。這絕對是 2022 年的計劃。因此，我們的目標和我們關於將向這些測試中心推動案例的銷售代表的增加與今年第四季度達到頂峰的增加是一致的。節奏是我們同時在所有 9 個方面向前邁進。在某些地方，添加 - 識別和僱用這些從業者和代表比其他人更容易。所以這是一個多——這是一條同時跨越所有 9 個州的平行路徑，與我們在第一階段所做的形成對比，我們從 Phoenix 開始，然後我們做了 3 個，然後我們又做了 3 個。

Okay. Great. And I guess, since you guys really only need a small office at the end of the day, there hasn't been any trouble finding space in these metro cities, correct?

好的。偉大的。而且我想，既然你們真的只需要一天結束時的小辦公室，那麼在這些大都市中尋找空間沒有任何問題，對嗎？

No. I mean we have high standards. We look for nice space and nice locations that are either convenient for patients to -- based on traffic patterns and so forth, but there are plenty of -- these are not big locations. They are 2 or 3 offices, and they're not hard to find.

不，我的意思是我們有高標準。我們尋找方便患者的好空間和好位置——基於交通模式等，但有很多——這些都不是大的地方。他們有 2 或 3 個辦公室，而且不難找到。

Yes. Okay. Great. And then maybe just one around I guess revenue per test, a big drop off sequentially. Was this all based on cash collection timing? Or did this have anything to do with the coverage, the inclusion of coverage from the MediNcrease Health Plans? I don't know if you guys have already started receiving payments for that...

是的。好的。偉大的。然後可能只有一個左右，我猜每次測試的收入，連續大幅下降。這一切都是基於收款時間嗎？或者這是否與覆蓋範圍有關，包括 MediNcrease 健康計劃的覆蓋範圍？我不知道你們是否已經開始為此收到付款...

Yes. It has nothing to do with -- I'll just briefly comment and let Dennis add to it. It has nothing to do with the reimbursement issues around Medicare or otherwise. It's entirely timing with regard to the transition between the model where we were collecting a fixed revenue -- fixed amount of fixed payments from ResearchDx, which was the provider of record and the billing entity going into February. And that transitioned to us billing directly. It's entirely based on that. It's not -- there's no issue with regard to sort of blips in volume or in reimbursement or anything like that. Dennis, do you want to maybe elaborate a little more?

是的。這與 - 我只是簡要評論並讓 Dennis 補充。它與 Medicare 或其他方面的報銷問題無關。關於我們收取固定收入的模型之間的過渡完全是時機 - 來自 ResearchDx 的固定金額固定付款，這是記錄的提供者和進入 2 月的計費實體。這直接轉移到了我們的賬單上。這完全基於此。這不是——關於數量或報銷或類似的問題，沒有任何問題。丹尼斯，你想詳細說明一下嗎？

Yes, sure. Joseph, it was purely formulaic. We had been collecting $100,000 per month from ResearchDx, $189,000 recognized was $100,000 for January and 25 of 28 days in February times $100,000 gives you $89,000. The test that we can bill after February 25, because of our own lab, have all been delayed until we have our own revenue cycle provider up and running. So all of the tests that were done in March, which were significant, will be billed, and that will occur. It's creating obviously a timing delay, but they will be build. And we will collect. If it's at the out-of-network rates, we use the -- the past is kind of an indication of what the out-of-network rates there. It's somewhere between $1,000 and $1,300 per test, and we expect to be able to collect that. So purely formulaic in terms of the past arrangement and the transition from using a third-party lab provider to our own lab.

是的，當然。約瑟夫，這純粹是公式化的。我們每月從 ResearchDx 收取 100,000 美元，1 月份的 189,000 美元是 100,000 美元，2 月份的 28 天中有 25 天乘以 100,000 美元得到 89,000 美元。由於我們自己的實驗室，我們可以在 2 月 25 日之後開具賬單的測試都被推遲了，直到我們有自己的收入周期提供商啟動並運行。因此，所有在 3 月份完成的重要測試都將被計費，並且會發生。這顯然造成了時間延遲，但它們將被構建。我們會收集。如果它是網絡外費率，我們使用 - 過去表明那裡的網絡外費率是多少。每次測試的費用在 1,000 美元到 1,300 美元之間，我們希望能夠收取這筆費用。就過去的安排以及從使用第三方實驗室提供商到我們自己的實驗室的過渡而言，這純粹是公式化的。

That makes perfect sense. Congrats on the quarter.

這是完全有道理的。祝賀這個季度。

Yes. Thanks Joseph.

是的。謝謝約瑟夫。

Thanks, Joseph.

謝謝，約瑟夫。

And our next question comes from Kyle Mikson with Canaccord Genuity.

我們的下一個問題來自 Canaccord Genuity 的 Kyle Mikson。

Kyle, you there?

凱爾，你在嗎？

Kyle, you may be on mute.

凱爾，你可能靜音了。

Kyle, your line is live, if you are there? Okay. I guess he is not with us at the moment. Our next question comes from Ed Woo with Ascendiant Capital.

凱爾，如果你在的話，你的線路是實時的嗎？好的。我想他現在不在我們身邊。我們的下一個問題來自 Ascendiant Capital 的 Ed Woo。

Yes. In terms of -- there's a lot of discussions about inflation. I'm sure it's hitting everybody, including you guys. How often do you guys get to change your reimbursement rate? Is this something that is revisited annually? And do you think that's going to have any impact with rising costs, especially for personnel, nurses or whatnot for your business?

是的。就-有很多關於通貨膨脹的討論。我敢肯定它會影響到所有人，包括你們。你們多久更改一次報銷率？這是每年都要重新審視的事情嗎？您認為這會對成本上升產生任何影響，尤其是對人員、護士或您的業務的其他因素嗎？

Yes. It's a great, great question. I mean, I think just at a high level, historically, set reimbursement from payers, whether it be Medicare or private payers are really not indexed for inflation. And we don't have sort of the luxury of going back to the, well, on an annual basis. So fortunately, these -- we have really healthy margins with these rates, and we'll be in position.

是的。這是一個很好的問題。我的意思是，我認為只是在高水平上，從歷史上看，支付者的報銷，無論是醫療保險還是私人支付者，都沒有與通貨膨脹掛鉤。而且我們沒有那種每年都回到的奢侈。幸運的是，這些——我們以這些利率獲得了非常可觀的利潤率，我們將處於有利位置。

As it relates to sort of our COGS, hasn't been a cost of goods -- sorry, there hasn't been much in the way of an impact there. Although we do see supply chain challenges on parts and subsets and things like that. So that's something we monitor carefully, and we try really hard to order long lead time items well in advance. But on the payment side, we're lucky to get what we get, and we have a healthy margin built in, so.

由於它與我們的 COGS 相關，並不是商品成本——抱歉，那裡沒有太大影響。儘管我們確實看到了零件和子集等方面的供應鏈挑戰。所以這是我們仔細監控的事情，我們非常努力地提前訂購長交貨期的物品。但在支付方面，我們很幸運能得到我們所得到的，而且我們有一個健康的利潤率，所以。

Great. And then can you talk a little bit about some of your medical supplies? You don't see any impact near term because you guys have been able to order early enough in order to get whatever you need to...

偉大的。然後你能談談你的一些醫療用品嗎？短期內看不到任何影響，因為你們已經能夠儘早訂購以獲得您需要的任何東西......

We do our best, yes. And we did -- and we have had some challenges I've talked about on PAVmed calls in the last couple of quarters. But with regard to Lucid, it's really fairly -- we haven't had any issues. The EsoCheck manufacturing, we have ordered plenty of long, long lead time items. Our team is very meticulous about that. I didn't mention in our call, but we are making progress towards wrapping up the transition to our high-volume manufacture -- EsoCheck manufacturer, Coastline, in the coming months. So it hasn't been an issue. And with regard to the laboratory itself, reagents and so forth, that hasn't been challenging there yet. So fingers crossed, it will stay that way.

我們盡力而為，是的。我們做到了——我們遇到了一些挑戰，我在過去幾個季度的 PAVmed 電話會議上談到過。但關於 Lucid，這真的很公平——我們沒有遇到任何問題。 EsoCheck 製造，我們已經訂購了大量交貨期很長的產品。我們的團隊對此非常細緻。我沒有在我們的電話中提到，但我們正在朝著在未來幾個月內完成向我們的大批量生產——EsoCheck 製造商 Coastline 的過渡取得進展。所以這不是問題。至於實驗室本身、試劑等，還沒有挑戰。所以祈禱吧，它會保持這種狀態。

And our next question is from Kyle Mikson with Canaccord.

我們的下一個問題來自 Canaccord 的 Kyle Mikson。

Sorry for that. So just curious about the private payer coverage like efforts in the quarter. I mean, we saw the CMS updates and then just there was definitely some, I don't want to say noise, but there was obviously -- it was kind of an exciting quarter for, I guess, like your space in particular. What did -- how did private payers kind of interact? Or are you even having those discussions today?

對不起。所以只是對私人付款人的覆蓋範圍感到好奇，比如本季度的努力。我的意思是，我們看到了 CMS 更新，然後肯定有一些，我不想說噪音，但顯然 - 這是一個令人興奮的季度，我想，尤其是你的空間。什麼 - 私人付款人如何互動？還是您今天甚至進行了這些討論？

We're having -- yes, we are having those discussions. And the MediNcrease contract is the first of that, and we have more we're working on, and we expect to steadily. As I said before, the private side is sort of blocking and tackling in order to combat, not to be overly dramatic about it. But -- so no, we've been -- again, I think that's -- the proof is in this -- is in our first commercial payer contract, which happened after the proposed LCD was published.

我們正在進行——是的，我們正在進行這些討論。 MediNcrease 合同是其中的第一個，我們還有更多的工作要做，我們希望穩步進行。正如我之前所說，私人方面是為了戰鬥而攔截和攔截，而不是過於戲劇化。但是 - 所以不，我們已經 - 再一次，我認為 - 證據就在這 - 在我們的第一份商業付款人合同中，這是在擬議的 LCD 發布之後發生的。

Okay. And yes, apologies if you mentioned this in advance. Obviously, was having phone issues. Maybe just with the test center kind of expansion and then as those ramp up, I mean, any like incremental takeaways? Like are you going to be making any changes to those centers going forward? I mean, are you going to accelerate efforts? I mean just curious like if you take a step back, what you think at this point...

好的。是的，如果您提前提到了這一點，我們深表歉意。很明顯，手機有問題。也許只是隨著測試中心的擴張，然後隨著測試中心的增加，我的意思是，任何像增量外賣？比如你打算對這些中心做出任何改變嗎？我的意思是，你會加快努力嗎？我的意思是只是好奇，如果你退後一步，你在這一點上的想法......

I'd try to point out, but this maybe is a good opportunity to reemphasize the point that I did touch on in the comments -- in my prepared remarks, which is that, right now, we're kind of looking at sort of a mid-level trajectory, right? I mean we could -- as I said, we really feel like the model is well honed. The test center model works. Our training has become really good. We have some predictability now with regard to translating deployment of sales reps and opening of test centers to testing volume. And 1 of the trends we've noticed, we don't have enough data points to report this but we will in the coming quarters, is that we have seen a nice increase in the proportion of our cases that are coming through from primary care physicians and test centers.

我會嘗試指出，但這也許是一個很好的機會來再次強調我在評論中提到的觀點——在我準備好的評論中，那就是，現在，我們正在考慮某種中級軌跡，對吧？我的意思是我們可以——正如我所說，我們真的覺得這個模型已經很成熟了。測試中心模型有效。我們的訓練變得非常好。關於將銷售代表的部署和測試中心的開放轉化為測試量，我們現在有一些可預測性。我們注意到的趨勢之一是，我們沒有足夠的數據點來報告這一點，但我們會在未來幾個季度報告，我們已經看到來自初級保健的病例比例有了很大的增加醫生和測試中心。

And that's an important metric of how that's working. But we're trying to take a middle ground here. We want to obviously grow testing volume to generate data for clinical utility to support reimbursement and to generally prove that the model works. But we are also cognizant of the fact that, right now, we don't have predictable reimbursement. We are starting to bring some of that in, but we're not at the stage where we're getting -- a large portion of these cases are getting full reimbursement.

這是衡量其運作方式的重要指標。但我們正試圖在這裡採取中間立場。我們顯然希望增加測試量以生成臨床效用數據以支持報銷並普遍證明該模型有效。但我們也意識到，目前我們沒有可預測的報銷。我們開始引入其中的一些，但我們還沒有達到我們得到的階段——這些案例中的很大一部分正在獲得全額報銷。

So with an eye towards being protective of our cash and our capital, we're trying to take sort of a middle-of-the-road approach. With regard to the throttle, not to use the metaphor, but once we have more predictable reimbursement and then we start getting some of these -- more of these private payer agreements under our belt, then we have the ability to dial this up and to increase the cadence and so forth. But our plan really for the rest of this year is to stick with our targets with regard to the expansion of our sales force and the expansion of the test centers to give us time to start getting more predictable reimbursement. Hopefully, that makes sense.

因此，著眼於保護我們的現金和資本，我們正試圖採取一種中間路線。關於節流閥，不是使用比喻，而是一旦我們有更多可預測的報銷，然後我們開始獲得其中的一些——更多這些私人支付協議在我們的腰帶下，那麼我們就有能力撥通它並增加節奏等等。但我們今年餘下時間的計劃是堅持擴大銷售隊伍和擴大測試中心的目標，讓我們有時間開始獲得更可預測的報銷。希望這是有道理的。

Sure. And maybe if I could ask another -- just on the LCD and maybe fully reflecting that the -- they do not account for those guidelines yet. I just wanted to ask, though. It seems like EsophaCap type device is like included in the LCD. I mean I know the guidelines aren't included. Maybe I can get EsoCheck in there. When is the next kind of milestone or benchmark we should be looking for? I know there was a recent meeting. Just like curious what is on the horizon? And yes -- and what...

當然。也許我可以問另一個人——只是在 LCD 上，也許完全反映了——他們還沒有考慮到這些指導方針。不過我只是想問問。看起來 EsophaCap 類型的設備就像包含在 LCD 中一樣。我的意思是我知道指南不包括在內。也許我可以在那里安裝 EsoCheck。我們應該尋找的下一個里程碑或基準是什麼時候？我知道最近有一次會議。就像好奇地平線上有什麼？是的——還有什麼……

There's a lot to clarify. So the guidelines recommend non-endoscopic biomarker testing with a capsule device. That includes EsoCheck, just to be clear. It's right there. It's a photograph of it -- the results of the -- from the STM paper are in there. So although EsophaCap is there as well, EsoCheck is featured, and we consider the guidelines supporting EsoGuard and EsoCheck. So I don't want there to be any confusion about that. The -- that's sort of the guidelines.

有很多事情要澄清。因此指南建議使用膠囊裝置進行非內窺鏡生物標誌物檢測。需要說明的是，這包括 EsoCheck。它就在那裡。這是一張它的照片——來自 STM 論文的結果就在那裡。因此，雖然 EsophaCap 也在那裡，但 EsoCheck 具有特色，我們考慮支持 EsoGuard 和 EsoCheck 的指南。所以我不希望對此有任何混淆。這就是指導方針。

So the open meeting I thought went well. It was substantive, serious. We had plenty of opportunity, us and other stakeholders, to describe what we think are useful modifications to the LCD. The goal is to have the LCD really be an operational, foundational LCD, so that the criteria are a bit clear. And that when we get the sufficient clinical utility data to submit as part of a technical assessment, it doesn't require revisiting and reopening the LCD. And that was really the focus of our comment as well as others. And the written comments are going to really push that a lot harder from us as well as multiple other stakeholders.

所以我認為公開會議進行得很順利。這是實質性的，嚴肅的。我們和其他利益相關者有很多機會來描述我們認為對 LCD 進行的有用修改。目標是讓 LCD 真正成為一個可操作的、基礎的 LCD，這樣標準就有點清晰了。當我們獲得足夠的臨床實用數據作為技術評估的一部分提交時，不需要重新訪問和重新打開 LCD。這確實是我們和其他人評論的重點。書面評論將真正推動我們以及其他多個利益相關者更加努力地做到這一點。

The -- as I mentioned, I mean the open meeting occurred yesterday. The written comments period for Palmetto end on Saturday. But we were also notified that Noridian, which is the Medicare contractor that covers California and covers lab there and will be ultimately the contractor of record, also scheduled an open meeting and a comment period. Open meeting there is going to be on May 26, and the comment period ends on June 11. So that gives us another bite at the apple to really make the case and make sure that final LCD that comes to this is -- really gives this -- not just us, but the field, the opportunity to get coverage for this really important and now guidelines based option to perform wide-spread testing in these at-risk patients.

正如我提到的，我的意思是昨天召開了公開會議。 Palmetto 的書面評論期將於週六結束。但我們也獲悉，Noridian 是覆蓋加利福尼亞州並覆蓋那裡實驗室的 Medicare 承包商，最終將成為記錄在案的承包商，它還安排了一次公開會議和評論期。公開會議將於 5 月 26 日舉行，意見徵詢期將於 6 月 11 日結束。因此，這讓我們又咬了一口蘋果，真正證明了這一點，並確保最終的 LCD 是——真的給出了這個- 不僅是我們，還有這個領域，有機會覆蓋這個非常重要且現在基於指南的選項，以便在這些高危患者中進行廣泛的測試。

Yes. I mean we're all looking forward to seeing how the guidelines impact the LCD hopefully. So we'll find out then.

是的。我的意思是，我們都期待著看到指南如何有希望地影響 LCD。所以我們會找出答案。

At this time, we have reached the end of the question-and-answer session. And I will now turn the call back over to Lishan Aklog for closing remarks.

此時，我們已經到了問答環節的尾聲。我現在將把電話轉回給 Lishan Aklog 以作結束語。

Great. So well, thank you, everyone, for joining us today, and as always, great questions. And as always, we look forward to keeping you abreast of our progress, of the press releases of these conference calls. The best way to keep up with the Lucid news updates and events is to sign up for our e-mail alerts on the Lucid Investors website and to follow us on social media on LinkedIn, Twitter and YouTube as well as through our website. So you can also contact Adrian Miller, our VP of Investor Relations, at akm@pavmed.com. So thanks again, and have a great rest of your day.

偉大的。好吧，謝謝大家今天加入我們，一如既往地提出很好的問題。與往常一樣，我們期待讓您了解我們的進展以及這些電話會議的新聞稿。了解 Lucid 新聞更新和事件的最佳方式是在 Lucid Investors 網站上註冊我們的電子郵件提醒，並在 LinkedIn、Twitter 和 YouTube 以及我們的網站上關注我們的社交媒體。因此，您也可以通過 akm@pavmed.com 聯繫我們的投資者關係副總裁 Adrian Miller。再次感謝，祝您度過愉快的一天。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與，祝您有美好的一天。