Lucid Diagnostics Inc (LUCD) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good morning, ladies and gentlemen, and welcome to the Lucid Diagnostics second quarter 2026 business update conference call. (Operator Instructions) This call is being recorded on Thursday, August 13, 2026.

    各位女士、先生,早安,歡迎參加 Lucid Diagnostics 2026 年第二季業務更新電話會議。(接線員指示) 本通話於 2026 年 8 月 13 日(星期四)錄音。

  • I would now like to turn the conference over to Matt Riley, Lucid Diagnostics Vice President of Investor Relations. Please go ahead.

    現在我想把會議交給 Lucid Diagnostics 投資人關係副總裁 Matt Riley。請開始。

  • Matt Riley - Director of Investor Relations

    Matt Riley - Director of Investor Relations

  • Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of Lucid Diagnostics; along with Dennis McGrath, Chief Financial Officer.

    謝謝接線員,各位早安。感謝各位參與今天的業務更新電話會議。今天與我一同出席的有 Lucid Diagnostics 董事長兼執行長 Lishan Aklog 醫師,以及財務長 Dennis McGrath。

  • The press release announcing our business update and financial results is available on Lucid's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update, press release, and conference call all 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.

    宣布我們業務更新與財務結果的新聞稿已發布於 Lucid 的網站。請花點時間閱讀新聞稿中關於前瞻性陳述的免責聲明。本次業務更新、新聞稿與電話會議皆包含前瞻性陳述,而這些前瞻性陳述受已知與未知的風險與不確定性影響,可能導致實際結果與所述內容出現重大差異。

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

    可能導致實際結果不同的因素已在免責聲明以及我們向美國證券交易委員會(SEC)提交的文件中說明。如需這些及其他可能影響未來營運之重要風險與不確定性的清單與說明,請參閱 Lucid 最近一期向 SEC 提交的 Form 10-K 年度報告中第 1 部分第 1A 項「風險因素」,以及其後在 Form 10-Q 季度報告與後續 Form 8-K 中提交的任何更新。

  • 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 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 不承擔亦無意公開更新或修訂任何前瞻性陳述,以反映預期的變化,或反映作為預期基礎之事件、狀況或情勢的變動,或反映可能影響實際結果與前瞻性陳述所載內容出現差異之可能性的因素。

  • I would now like to turn the call over to Dr. Lishan Aklog.

    現在我想把電話會議交給 Lishan Aklog 醫師。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Thank you, Matt, and good morning, everyone. Thank you for joining us today and for your continued engagement and support. We continue to make strong progress across key commercialization initiatives as we await Medicare draft LCD publication, and we're eager to discuss these today.

    謝謝你,Matt,各位早安。感謝各位今天加入我們,並持續關注與支持。在等待 Medicare 的 LCD 草案公布之際,我們在關鍵商業化推進項目上持續取得強勁進展,也很期待今天與各位討論。

  • Let's begin with some key highlights from the second quarter and recently. This quarter, our laboratory performed 2,770 EsoGuard tests, and we recognized $1.5 million in revenue. Revenue is up about 17% from the prior quarter, and our volume remains within our target range of approximately 2,500 to 3,000 tests. This reflects increased commercial focus on testing opportunities that are likely to drive revenue. In addition, we secured our first laboratory benefit manager commercial coverage policy from Concert.

    先從第二季以及近期的一些重點摘要開始。本季,我們的實驗室完成了 2,770 次 EsoGuard 檢測,並認列 150 萬美元營收。營收較上一季成長約 17%,檢測量仍維持在我們約 2,500 至 3,000 次的目標區間內。這反映出我們在更可能帶動營收的檢測機會上加強了商業端的聚焦。此外,我們也從 Concert 取得了第一份由實驗室福利管理機構(LBM)提供的商業保險給付政策。

  • The Concert policy has already been adopted by multiple client health plans. This is a major commercial coverage milestone and represents third-party review of EsoGuard's clinical evidence. Concert concluded that EsoGuard is medically necessary for patients meeting established screening criteria and that the evidence definitively demonstrates improved health outcomes. We'll talk more about Concert and the significance of this policy shortly.

    Concert 的政策已被多家客戶健康保險計畫採用。這是商業保險給付方面的一項重大里程碑,也代表第三方對 EsoGuard 臨床證據的審查認可。Concert 的結論是:對符合既定篩檢標準的患者而言,EsoGuard 具有醫療必要性,且證據明確顯示可改善健康結果。我們稍後將進一步談談 Concert 以及此政策的重要意義。

  • Now let's turn to key updates related to market access and commercialization. With regards to Medicare, we continue to wait for publication of our draft LCD, but we remain confident that we will secure a positive draft policy. We do note that there's been a broad backlog at CMS with regard to LCD output. However, there does seem to be a sign that backlog may be loosening. Several long-awaited LCDs have been posted in recent weeks.

    接著談談與市場准入與商業化相關的重點更新。就 Medicare 而言,我們仍在等待 LCD 草案的發布,但我們仍有信心能取得正面的草案政策。我們也注意到 CMS 在 LCD 產出方面存在廣泛的積壓。不過,確實似乎有跡象顯示積壓可能正在鬆動。近幾週已有數份等待已久的 LCD 陸續公布。

  • With regard to the VA, this remains a very large opportunity for us, and the process is progressing very well. Our team has built a robust, high-quality pipeline of VA centers across the U.S., and most notably, our clinical engagement has been extremely positive. We're essentially getting no pushback from the clinicians. The team is making progress in translating those clinical engagements into contracts. A key focus is securing contracts for the new federal fiscal year, which begins on October 1.

    至於退伍軍人事務部(VA),這對我們而言仍是一個非常龐大的機會,而且流程進展得非常順利。我們的團隊已在全美建立了強健且高品質的 VA 中心管線;尤其值得一提的是,我們的臨床端互動回饋極為正面。我們基本上沒有受到臨床醫師的反對。團隊正持續推進,將這些臨床互動轉化為合約。其中一個重點是為新的聯邦會計年度(10 月 1 日開始)取得合約。

  • Next, let's try to provide some additional context on Concert and our commercial coverage updates. So as anticipated last week, Concert issued positive coverage policy for EsoGuard, representing our first laboratory benefit manager LBM coverage policy. They specifically covered our test but noted that other esophageal precancer tests that were evaluated were considered investigational due to insufficient evidence.

    接下來,我們試著就 Concert 與我們的商業保險給付更新提供更多背景。如同上週所預期,Concert 已為 EsoGuard 發布正向的給付政策,這是我們第一份由實驗室福利管理機構(LBM)提供的給付政策。他們明確涵蓋了我們的檢測,但也指出其他接受評估的食道癌前病變檢測因證據不足而被視為研究性(investigational)。

  • Let's talk a little bit about how laboratory benefit managers work. Laboratory benefit managers concentrate the technical assessment of molecular diagnostic tests into single entities, and client health plans contract with them in order to ensure coverage policy.

    我們稍微談談實驗室福利管理機構如何運作。實驗室福利管理機構會將分子診斷檢測的技術性評估集中由單一機構進行,而客戶健康保險計畫會與其簽約,以確保給付政策的制定與落實。

  • Three of Concert's client plans have adopted our policy with several more expected to do so in the coming months. Not all plans permit public announcements, so we won't necessarily be presenting that publicly. The plans that have adopted the policy are somewhat concentrated. Securing these regional commercial plans enhances our ability to allocate resources accordingly. We continue to be actively engaged with all the other laboratory benefit managers, and we do feel confident that the Concert policy will set a precedent for others.

    Concert 的三家客戶保險計畫已採用我們的政策,未來幾個月預期還會有更多採用。並非所有保險計畫都允許對外公開宣布,因此我們未必會公開揭露。已採用該政策的保險計畫在地理分布上相對集中。取得這些區域型商業保險計畫,有助於我們相應地配置資源。我們也持續與其他所有實驗室福利管理機構積極互動,並且有信心 Concert 的政策將為其他機構樹立先例。

  • Moving on to healthcare economic research. Unlike with Medicare, an important tool for commercial coverage is demonstrating cost-effectiveness. We have partnered with the lead author of the American College of Gastroenterology guidelines and have developed a sophisticated cost-effectiveness model, working alongside HEOR experts and international key opinion leaders in Barrett's esophagus and esophageal cancer.

    接著談醫療經濟研究。不同於 Medicare,對商業保險給付而言,一項重要工具是證明具成本效益。我們已與美國胃腸病學會(American College of Gastroenterology)指引的主要作者合作,並在健康經濟與結果研究(HEOR)專家及巴瑞特食道與食道癌領域的國際關鍵意見領袖共同參與下,建立了一套精密的成本效益模型。

  • This model compares the long-term clinical and economic impact of EsoGuard screening versus current care across the at-risk population. It's very important to take a long-term view of these cost-effectiveness models, particularly in screening, where the benefits of early detection can take years to emerge. The model assessed the impact on BE detection, on esophageal cancer stage shifting, esophageal cancer avoidance, and esophageal cancer-related mortality.

    該模型比較在高風險族群中,採用 EsoGuard 篩檢相較於現行照護在長期臨床與經濟影響上的差異。在成本效益模型中採取長期視角非常重要,尤其是在篩檢領域,早期偵測的效益可能需要多年才會顯現。該模型評估了對 BE(巴瑞特食道)偵測、食道癌分期前移、避免食道癌發生,以及食道癌相關死亡率的影響。

  • This information helps payers assess whether the clinical benefits of EsoGuard DNA justify the cost. The model is expected to be completed this summer, but the preliminary results are actually very encouraging and show positive clinical impact, with EsoGuard appearing as cost-effective compared to current care.

    這些資訊可協助保險支付方評估 EsoGuard DNA 的臨床效益是否足以合理化其成本。該模型預計於今年夏季完成,但初步結果其實非常令人鼓舞,顯示正向的臨床影響,且 EsoGuard 相較於現行照護看起來具成本效益。

  • The other key area of focus is our engagement with health systems. There's extensive health system work underway and it's a major part of our commercialization strategy. We're translating those initial conversations into active implementation work. This process is a long time -- can take -- the lead time of this can take a bit of time, but we're starting to see results from it.

    另一個關鍵聚焦領域是我們與醫療體系的合作推進。目前正進行大量與醫療體系相關的工作,這也是我們商業化策略的重要一環。我們正把初步對話轉化為實際的導入與落地執行工作。這個流程需要較長時間——可能需要——其前置期可能會花一些時間,但我們已開始看到成果。

  • Part of the work involves tailoring the clinical workflow, supporting patient identification, ordering, and results. The EHR plays a particularly important role in health systems with regard to automated patient identification, streamlining patients within the health systems toward EsoGuard testing as appropriate.

    部分工作涉及量身打造臨床工作流程,支援病患識別、開立檢測醫囑與結果回報。在健康體系中,EHR 在自動化病患識別方面扮演特別重要的角色,可將病患在體系內的流程加以精簡,並在適當情況下引導其接受 EsoGuard 檢測。

  • So, in summary, we really are getting meaningful traction across market access and our commercialization efforts, and we haven't been idle as we await Medicare coverage. Obviously, Medicare coverage remains our most important near-term milestone, and we remain confident we will secure a positive draft policy.

    因此,總結來說,我們在市場准入與商業化推進方面確實取得了實質進展,而且在等待 Medicare 覆蓋期間我們也並未停滯。顯然,Medicare 覆蓋仍是我們近期最重要的里程碑,我們仍有信心能取得正面的政策草案。

  • Our VA work, as I noted, is progressing well, and we expect that success to build in the new budget cycle and contribute to future revenue growth. Commercial coverage, economic evidence, and health system infrastructure are all advancing extremely well. Collectively, this progress is increasing Lucid's visibility and creating interesting opportunities for broader strategic engagement.

    如我所提,我們在 VA 的工作進展順利,我們預期這項成功將在新的預算週期中持續累積,並帶動未來營收成長。商業保險覆蓋、經濟性證據與健康體系基礎建設都在非常順利地推進。整體而言,這些進展正在提升 Lucid 的能見度,並創造出更廣泛策略性合作的有趣機會。

  • So with that, I'll turn it over to Dennis for the financial update.

    接下來,我把時間交給 Dennis 進行財務更新。

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • Thanks, Lishan, and good morning, everyone. The summary financial results for the second quarter were reported in our press release that has been distributed. On the next three slides, I'll emphasize a few key financial highlights from the second quarter, but I encourage you to consider these remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q.

    謝謝你,Lishan,各位早安。第二季的財務結果摘要已在我們發布並已對外發送的新聞稿中揭露。接下來三張投影片,我會強調第二季幾項關鍵財務重點,但也鼓勵各位在閱讀時,結合我們於 Form 10-Q 季報中完整揭露的內容一併理解。

  • With regard to the balance sheet, cash at quarter end, June 30, was $33.4 million, which is essentially flat with the year-end balance. We completed a common stock offering during the quarter with net proceeds of about $16.8 million. The average burn rate for the last four quarters, including cash interest on the debt, was $11.6 million per quarter, with the second quarter a little bit lower at $11.3 million.

    就資產負債表而言,截至 6 月 30 日的季末現金為 3,340 萬美元,與年末餘額基本持平。我們在本季完成一次普通股發行,淨募資約 1,680 萬美元。過去四個季度的平均現金消耗率(包含債務的現金利息)為每季 1,160 萬美元,第二季略低,為 1,130 萬美元。

  • Our $22 million secured convertible debt is a five-year note, interest only at 12% with $1 conversion price, which is held by long-term shareholders. The fair value of the convertible notes in the amount of $23.5 million at quarter end is really the only other substantive change from the previously reported balances at the end of the year and also at the end of the first quarter. The fair value decrease of $1.7 million in the quarter reflects a mark-to-market quarterly adjustment in parallel with the common stock price changes between the periods. The fair value decrease also is a substantial part of the second quarter income pickup of $1 million reflected in other income in the P&L.

    我們 2,200 萬美元的有擔保可轉換債務為五年期票據,年利率 12% 且僅付利息,轉換價格為 1 美元,由長期股東持有。季末可轉換票據的公允價值為 2,350 萬美元,這幾乎是相較於先前在年末及第一季末所報告餘額的唯一其他重大變動。本季公允價值減少 170 萬美元,反映依期間普通股股價變動所做的按市價計量(mark-to-market)季度調整。該公允價值下降亦是第二季損益表中列於其他收益、約 100 萬美元收益回沖的重要組成部分。

  • Shares outstanding, including unvested restricted stock awards, and the earlier conversion of the remainder of the preferred shares, are approximately 203 million. After the conversion of the Series B1 preferred shares on May 6, there were approximately 22 million common shares held in abeyance due to the 4.99% ownership blockers in the former Series B and B1 certificate of designation. If these abeyance shares had been issued, common shares outstanding would be around 225 million. The GAAP outstanding shares as of June 30 of 190.8 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q. GAAP shares do not reflect unvested RSA amounts, and there are no longer any preferred shares outstanding.

    流通在外股數(包含尚未歸屬的限制性股票獎勵),以及先前其餘優先股的轉換,約為 2.03 億股。在 5 月 6 日 B1 系列優先股轉換後,由於原 B 系列與 B1 系列指定證書中的 4.99% 持股上限(ownership blockers),約有 2,200 萬股普通股被暫緩發行。若這些暫緩股已發行,普通股流通在外股數將約為 2.25 億股。截至 6 月 30 日的 GAAP 流通在外股數為 1.908 億股,投影片上以及 10-Q 資產負債表的表面均有反映。GAAP 股數不包含尚未歸屬的 RSA 數量,且目前已不再有任何優先股流通在外。

  • At present, PAVmed continues to be the single largest common shareholder of Lucid Diagnostics, with ownership of approximately 15% of the common shares outstanding. Although PAVmed no longer has voting control of Lucid, they, with the board and management, still have a considerable influence over Lucid with approximately 25% voting interest. With regard to the P&L, this slide compares this year's second quarter to last year's second quarter and year-over-year on certain key items.

    目前,PAVmed 仍是 Lucid Diagnostics 最大的單一普通股股東,持有約 15% 的流通在外普通股。雖然 PAVmed 已不再擁有 Lucid 的表決控制權,但其與董事會及管理層合計仍具有相當影響力,約擁有 25% 的表決權益。就損益表而言,本投影片比較今年第二季與去年第二季,並就若干關鍵項目呈現年對年變化。

  • Trust you'll review the information in my comments in the light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information. Our sales team sold 2,770 tests for the second quarter, with a billable value over $7.5 million, resulting in recognized revenue of $1.5 million. The test volume is within the range we have been targeting in this pre-Medicare time period. With new investors once again joining us for this call, it's worth repeating what we've communicated in past quarters about revenue recognition. The key determinant of how revenue is recognized at this point in our reimbursement journey is the probability of collection.

    請各位在閱讀我評論中的資訊時,留意投影片底部關於補充資訊(特別是非 GAAP 資訊)的警示性揭露。我們的銷售團隊在第二季售出 2,770 項檢測,計費價值超過 750 萬美元,因而確認營收 150 萬美元。檢測量落在我們在 Medicare 覆蓋前這段期間所設定的目標區間內。由於本次電話會議再次有新投資人加入,值得重申我們在過去幾季對營收認列所做的說明。在我們目前的給付(reimbursement)進程中,決定營收如何認列的關鍵因素,是收款的可能性(probability of collection)。

  • Therefore, due to the fact that we are in the transitional stages of our reimbursement process, means revenue recognition for the majority of our claims submitted to traditional government or private health insurance will be recognized when the claim is actually collected.

    因此,由於我們正處於給付流程的過渡階段,我們向傳統政府或民間健康保險提交的大多數理賠,其營收將在理賠實際收款時才予以認列。

  • Versus when the patient's report is delivered, invoiced, and submitted for reimbursement. As you'll see in our 10-Q, this is called variable consideration in the jargon of GAAP's ASC 606 revenue recognition guidelines, and presently, there is insufficient predictive data to reflect revenue from all of our quarterly test volume at the point where the test is delivered to the referring physician.

    而不是在病患報告交付、開立發票並提交申請給付時認列。如各位在 10-Q 中所見,依 GAAP 的 ASC 606 營收認列指引術語,這稱為「可變對價」(variable consideration);目前仍缺乏足夠的可預測數據,使我們能在檢測結果交付給轉介醫師時,就將當季全部檢測量的營收一併反映。

  • For billable amounts contracted directly with employers, including the VA, and that are fixed and determinable, will be recognized as revenue when our contracted service is delivered. Generally, that means when the report is delivered to the referring physician. It's important to note that a pending Medicare approval decision impacts 40% to 50% of our addressable patient population, and therefore will have a significant impact on our future revenue recognition analysis.

    對於直接與雇主(包含 VA)簽約的可計費金額,且金額固定且可確定者,將在我們提供約定服務時認列為營收。一般而言,這表示在報告交付給轉介醫師時。需要強調的是,尚待決的 Medicare 核准決策影響我們可觸及病患族群的 40% 至 50%,因此將對我們未來的營收認列分析產生重大影響。

  • Furthermore, for tests performed on Medicare patients with dates of service within 12 months of a final positive Medicare policy, we'll also get paid within a reasonable timeframe after the final policy is issued. With regard to the remainder of the P&L, the second quarter's total OpEx on both a GAAP and a non-GAAP basis is slightly higher than the first quarter by about 5%, reflecting expected increases in commercial activities, including headcount and sales personnel, clinical service staff, and market access. The non-GAAP net loss per share of $0.06 in the second quarter is better by about a penny sequentially and about $0.04 versus each of the previous three quarters prior to that.

    此外,對於服務日期落在最終正面 Medicare 政策發布前 12 個月內的 Medicare 病患所進行的檢測,我們也將在最終政策發布後的合理期間內收到款項。至於損益表其餘部分,第二季在 GAAP 與非 GAAP 基礎下的總營業費用(OpEx)較第一季略高約 5%,反映商業活動的預期增加,包括人力編制與銷售人員、臨床服務人員以及市場准入等。第二季非 GAAP 每股淨損為 0.06 美元,較上一季依序改善約 0.01 美元,且相較於再之前三個季度各自改善約 0.04 美元。

  • With regard to our operating expenses, this slide is a graphic illustration of our operating expenses after eliminating non-cash expenses for the period is reflected. Non-GAAP operating expenses of $12.3 million are basically in line with the average non-GAAP OpEx for the previous five quarters. That is $12.3 versus an average of $12.2 million for those five quarters.

    就我們的營業費用而言,本投影片以圖示方式呈現剔除本期非現金費用後的營業費用。非 GAAP 營業費用為 1,230 萬美元,基本上與前五個季度的非 GAAP 平均營業費用一致。也就是 1,230 萬美元,相較於那五個季度平均的 1,220 萬美元。

  • Let me close with a few reimbursement highlights for the second quarter. In the second quarter, as mentioned, we sold almost 2,800 tests, reflecting about $7.6 million in pro forma revenue at our list price of $2,749. During the second quarter, we recognized revenue of about 19% of that amount, or $1.5 million. Recognized revenue included about 35% from insurance claims submitted in the prior quarters, with the longest dated item over two years ago.

    最後我以第二季幾項報銷重點作結。如先前所提,第二季我們售出將近2,800項檢測,按我們每項2,749美元的定價計算,形式上(pro forma)收入約為760萬美元。第二季我們認列了約該金額的19%,也就是150萬美元的收入。已認列收入中,約35%來自前幾季提交的保險理賠,其中最久的一筆可追溯至兩年多前。

  • Of the claims submitted in the second quarter, about 65% have been adjudicated and 35% are pending. Out of the 65% that have been adjudicated, about 28% resulted in an allowable amount by the insurance company, with an average of $1,424 per test. Of those denied, most fit into one of three buckets: A, medically not necessary, deemed to be medically not necessary or investigational; or B, require prior authorization; or C, require additional medical records. The balance are deemed to be non-covered.

    第二季提交的理賠中,約65%已完成審理(adjudicated),35%仍在待處理中。在已審理的65%之中,約28%被保險公司核定為可給付金額(allowable amount),平均每項檢測為1,424美元。在被拒賠的案件中,多數可歸為三類之一:A,醫療上非必要,被認定為醫療上非必要或屬研究性(investigational);或B,需要事前授權(prior authorization);或C,需要補充更多病歷資料。其餘則被認定為不在承保範圍(non-covered)。

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

    那麼,接線員,請開放提問。

  • Operator

    Operator

  • (Operator Instructions) Kyle.

    (接線員指示) Kyle。

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • Hi, this is Alex Vukasin and I'm on for Kyle Mikson. The test volume remains essentially within the bounds of the guidance you've given us previously. So that comes to no surprise, really. How did the VA factor into the test volume during the quarter?

    你好,我是Alex Vukasin,我代替Kyle Mikson提問。檢測量基本上仍在你們先前給的指引範圍內。所以這其實不令人意外。本季VA(退伍軍人事務部)對檢測量的貢獻如何?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • The VA has not yet contributed meaningfully to the test volume. We're still in the process of engaging with the centers and working through budgets and contracting, and we're really in that phase. So that's going well. We're starting to secure contracts, and we'll start to see the VA contribute to our volume moving forward.

    VA目前尚未對檢測量做出有意義的貢獻。我們仍在與各中心接洽,並處理預算與簽約流程,正處於那個階段。所以進展良好。我們開始取得合約,接下來會逐步看到VA對我們量能的貢獻。

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • And so, looking at operating expenses, you noted there was an uptick during the quarter reflecting increasing commercial activities. Given the potential timing of the draft and final LCDs, can you just discuss plans to potentially accelerate SG&A in the next few quarters?

    再看營運費用方面,你提到本季因商業活動增加而有所上升。考量LCD草案與最終版可能的時程,你能否談談未來幾季是否有計畫加速SG&A(銷售、一般及行政費用)?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes, let me just start. As we've discussed before, as we're awaiting Medicare, we have been over the past couple of quarters, making some updates to our commercial infrastructure in order to be ready to accelerate our commercial activities upon securing broader reimbursement.

    好的,我先說明一下。如同我們之前討論過的,在等待Medicare(聯邦醫療保險)期間,過去幾季我們一直在更新商業化基礎建設,以便在取得更廣泛的報銷後,能夠加速商業活動。

  • So that involves shifting some of our commercial personnel to more senior personnel to more senior personnel so that we'll be able to scale more readily and adding a modest amount, as Dennis mentioned, to the overall commercial headcount.

    這包括將部分商業團隊人員調整為更資深的人才配置,以便更容易擴張,並如Dennis所提,適度增加整體商業團隊的人數。

  • Dennis, did you want to add anything?

    Dennis,你要補充嗎?

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • Yes, sure thing. So implicit in your question is also the implication in terms of burn and capital requirements. It's important to note when you think about that, yes, we are going to increase headcount. We are going to increase programs and take advantage of the reimbursement landscape as it improves.

    好的,當然。你問題背後也隱含了對現金消耗(burn)與資本需求的影響。在思考這點時,重要的是要注意:是的,我們會增加人力。我們會增加專案,並在報銷環境改善時把握機會。

  • But because we have a roughly $2,000 test and a 90% margin for the next patient in the door, you're not going to have the incremental burn that you otherwise would have if this was a 50% margin test at a lower price point. So one of the favorable things, or tailwinds, if you would, is just that, the test price, the margin. And yes, we are going to increase our OpEx, but it won't have the direct correlation to the burn that otherwise it might have.

    但因為我們每項檢測約2,000美元,且對於新增一位病患的邊際毛利率達90%,所以不會出現你在其他情況下可能看到的那種額外現金消耗;例如若這是一項價格較低、毛利率只有50%的檢測。因此其中一個有利因素(或稱順風,tailwinds)就在於檢測價格與毛利率。是的,我們會提高營運費用(OpEx),但它與現金消耗的關聯性不會像其他情況那麼直接。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • If I could also add one other thing, Alex, which is that as you'd sort of said in your first question, we do expect to start seeing the impact of our efforts at the VA as well as our efforts on the commercial payer side as we start to secure coverage policies and ultimately translate those into contracts and allocate resources accordingly. So, it's also in preparation for increased commercial activity related to the VA and the commercial side as well.

    Alex,我也想再補充一點:如你在第一個問題中提到的,我們確實預期會開始看到我們在VA的努力,以及在商業保險支付方(commercial payer)端的努力所帶來的影響,因為我們正開始取得承保政策,並最終把它們轉化為合約,並據此配置資源。所以這也是為了因應與VA及商業端相關的商業活動增加所做的準備。

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • One last one from me. So you recently contracted with your first LBM, efforts of which you alluded to during your discussions earlier this year. Can you just elaborate a bit more on this news, as well as the potential you could bring on additional LBMs into the fold in the near term prior to Medicare coverage?

    我最後一個問題。你們最近與第一家LPM(實驗室福利管理機構,LBM)簽約,這也是你們今年稍早討論時提到的努力方向。你能否再多談一些這項消息,以及在取得Medicare承保之前,短期內是否可能再納入其他LBM?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Thanks, Alex. I think the first part was just elaborating on the LBM itself and what that means, and then how this may serve as a launchpad for futures. Is that correct?

    謝謝你,Alex。我想第一部分是要我們多說明這家LBM本身以及其意義,然後再談這如何可能成為未來拓展的起點。是這樣嗎?

  • Alexander Vukasin - Analyst

    Alexander Vukasin - Analyst

  • Yes. Thank you.

    是的。謝謝。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes. Okay, great. So yes, we're quite excited about this. Maybe just a bit of an additional primer on how the system works. The diagnostic industry has -- on the coverage side -- on the commercial coverage side has laboratory benefit managers where they concentrate the technical expertise in assessing complex molecular diagnostic tests like ours.

    是的。好的,很好。我們對此非常興奮。我先簡單補充一下這個體系如何運作。診斷產業在承保端——特別是商業承保端——有「實驗室福利管理機構」(laboratory benefit managers),他們集中技術專業來評估像我們這樣複雜的分子診斷檢測。

  • And client health plans, regional as well as national plans, contract with these laboratory benefit managers to write coverage policies on their behalf. So this is a very big first step for us. This is our first laboratory benefit manager, Concert. And we're quite excited that the coverage policy that they wrote makes it clear that EsoGuard is medically necessary and really validates the bulk of our clinical evidence in support of that.

    而其客戶健康保險計畫(health plans),不論是區域型或全國型,會與這些實驗室福利管理機構簽約,由他們代表保險計畫撰寫承保政策。因此,這對我們而言是非常重要的第一步。這是我們第一家實驗室福利管理機構:Concert。我們非常高興他們所撰寫的承保政策明確指出EsoGuard在醫療上屬必要(medically necessary),並且確實驗證了我們用以支持該結論的大部分臨床證據。

  • And it did so looking at the entire landscape of potentially other products and found that only ours had sufficient evidence to justify that. So that was a big step and further validation of its importance is that three of its plans, three of the client plans, of Concert almost essentially immediately published their own coverage policies in sync with that, and we expect several more to come. This gives us an opportunity, as I mentioned in my prepared remarks, since often these plans tend to be regionally concentrated. It gives us the opportunity to allocate resources in a geographic fashion consistent with that.

    他們在檢視整個市場上可能的其他產品後,認定只有我們的產品具備足夠證據來支持這一點。因此這是重大進展;而其重要性的進一步驗證在於:Concert旗下三個客戶保險計畫幾乎是立即同步發布了各自的承保政策,我們也預期還會有更多跟進。如我在事先準備的發言中提到的,由於這些保險計畫往往在地理上呈現區域集中,這也讓我們有機會依照其分布,以地理方式配置資源。

  • The second part of your question is also extremely important. It's always important to get the first one under our belt in conversations with other plans and with other LBMs. Obviously, a very common question is who else is on board. So having Concert on board will certainly help us, and it's been a positive -- has had a positive impact on our ongoing discussions with other LBMs.

    你問題的第二部分也非常重要。在與其他保險計畫及其他LBM洽談時,先拿下第一家總是很關鍵。很常見的一個問題就是:還有哪些單位已經加入(on board)?因此,有Concert作為合作方肯定會幫助我們,而且也已對我們與其他LBM的持續討論帶來正面影響。

  • Operator

    Operator

  • Mark, BTIG.

    Mark,BTIG。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • I guess the first one, just maybe asking about CMS. I completely understand there's been a long queue for several years. I just wanted to maybe ask, I know there was at least one person who changed or is about to change his role at Palmetto GBA. I'm just curious if you think any of the personnel change might have any impact to your weight in front of Medicare?

    我想第一個問題可能是關於CMS。我完全理解這幾年一直有很長的排隊等待。我想問的是,我知道Palmetto GBA至少有一位人員已經更換或即將更換職務。我很好奇你是否認為這些人事變動可能會對你們在Medicare面前的推進力(weight)產生任何影響?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • We don't think so. As we've said before, we've been in close communication with the leadership at MolDX, and we obviously do our best to try to understand to the best of our ability what may be going on behind the scenes. We feel quite confident that things are in the late stages and that the work that went into getting us this far all the way through the tech meeting and beyond is already sort of built in, baked in.

    我們不這麼認為。如同我們先前所說,我們一直與 MolDX 的領導層保持密切溝通,當然也會盡我們所能去理解幕後可能正在發生的事情。我們相當有信心事情已進入後期階段,而且讓我們一路走到技術會議(tech meeting)及其後續的那些工作,基本上已經算是內建、已經「烘焙」進流程裡了。

  • So it's our understanding to the best of our ability to ascertain, that as you hinted at the beginning of your question, that there has been a bit of a prolonged backlog with the processing and the -- delays in processing LCDs coming out of the MACs, including MolDX and at CMS.

    因此,就我們目前所能掌握的理解而言,正如你在問題一開始所暗示的,MACs(包括 MolDX)以及 CMS 在處理 LCD 的流程上,確實出現了一些較長時間的積壓與——處理延遲。

  • There's a sort of a broad sense within the community that this may be loosening up as a couple of long-awaited LCDs that apparently were using up a significant amount of the bureaucratic bandwidth have come to fruition over the last couple of weeks. So we're hopeful that loosening will accelerate the process of -- processing our LCD.

    社群內普遍有一種看法,隨著過去幾週內幾項期待已久、顯然占用了大量行政資源的 LCD 終於落地,這種塞車狀況可能正在鬆動。因此我們希望,這種鬆動會加速——加速我們 LCD 的處理流程。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Okay, great. And then congrats again on getting Concert over the goal line. I guess can you just remind us, it looks like three of the plans have followed their coverage. If you could remind us how many plans look to Concert and, if all of them converted, do you have a sense for how many covered lives that could mean?

    好的,很棒。另外也再次恭喜 Concert 達陣。我想請你再提醒一下,看起來有三個方案已跟進其承保。可否提醒我們有多少方案會參照 Concert?如果全部都轉換,你們是否能估算可能代表多少承保人數(covered lives)?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes. Under Concert -- there are numerous plans under Concert leading to just under 10 million covered lives. All I can really say publicly is that three are on board. We expect a couple of more in the coming quarters. And then ultimately, we have every reason to believe that all of the client plans will ultimately mimic the coverage policy of the LBM.

    是的。在 Concert 之下——有許多方案,合計承保人數接近 1,000 萬。我公開能說的只有三個已加入。我們預期未來幾個季度還會再增加幾個。最終,我們有充分理由相信,所有客戶方案最終都會仿效 LBM 的承保政策。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Okay, perfect. If I can sneak one last one in. I just want to make sure that you're still planning to move in line with your target of 2,500 to 3,000 tests per quarter. And then I wanted to get a sense for how some of the activity is going just generally with firefighters and also with some of the more typical initiatives in primary care type clinics?

    好的,完美。如果我可以再塞最後一個問題。我只是想確認,你們仍計畫依照每季 2,500 到 3,000 次檢測的目標推進。另外我也想了解一下,整體而言,消防員相關的活動進展如何,以及在一些較典型的基層醫療(primary care)診所倡議方面的進展如何?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • So, yes, I think for now we're still targeting that range sort of as we prep behind the scenes and kind of make the modifications behind the scenes that I had mentioned in my earlier response. I think the trigger for us to start trying to drive up that volume by increasing our resources will really depend on, obviously the big trigger would be securing our draft coverage policy, but also the parallel efforts and traction at the VA and with our commercial plans will obviously influence that as well.

    所以,是的,我想目前我們仍以那個區間為目標,同時我們在幕後做準備,並進行我在先前回覆中提到的那些幕後調整。我們開始嘗試透過增加資源來拉升量能的觸發點,當然最主要會是取得我們的承保政策草案(draft coverage policy),但同時 VA 以及商業保險方案的平行推進與進展,也會明顯影響我們的判斷。

  • You know, as we've talked about previously, the mix of that volume, even though we've kind of reported a fairly steady number quarter-to-quarter, we're trying to shift that. That earlier that was dominated by the health care type event that you had described -- that you were hinting at, the firefighter events, as those were the most efficient ways for us to generate the test volume that we need to drive claim submissions and drive and support our engagement with the commercial payers.

    你知道,如同我們之前談過的,即便我們季度對季度報告的量看起來相當穩定,我們其實正試圖調整那個量的組成。先前那個量主要由你所描述——你所暗示的那類醫療型活動主導,也就是消防員活動,因為那是我們最有效率產生所需檢測量的方法,用以推動理賠申請(claim submissions),並推動與支持我們和商業支付方(commercial payers)的互動。

  • So behind the scenes, as we've talked about previously, we have been making adjustments to our commercial strategy, our incentive plans, and so forth, to start shifting that volume back towards more traditional engagements with primary care physicians and gastroenterologists and as we've described, health systems as well. And that is working.

    因此在幕後,如同我們先前談過的,我們一直在調整我們的商業策略、獎酬方案等,以便把量逐步轉回更傳統的合作模式:與基層照護醫師與腸胃科醫師的合作,以及如我們所述,也包括與醫療體系(health systems)的合作。而且這正在奏效。

  • We've also started to see -- also have been pushing the team to shift more of our health care events towards contracted plans where we have confidence and assurance that we'll get paid for. And that progress -- that's progressing as well. So as you may note that our revenue this quarter was up even though our test volume was flat, it's a reflection of those kind of behind-the-scenes efforts.

    我們也開始看到——同時也一直推動團隊,將更多醫療活動轉向那些我們已簽約、且我們有信心並能確保會獲得付款的方案。而這項進展——也在推進中。因此你可能注意到,本季即使檢測量持平,我們的營收仍上升,這反映的就是這些幕後努力。

  • Dennis, do you want to add anything to that?

    Dennis,你要補充一下嗎?

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • Yes, sure thing. So, Mark, maybe just a little bit more granularity, just expanding on what Lishan said. Our comp plans are now more heavily weighted towards what the team's calling MVAC, Medicare, VA, and contracted revenue. The contracted revenue would include firefighters and self-insured employers. It's an emphasis on getting paid.

    好的,當然。Mark,我再提供一點更細的資訊,延伸一下 Lishan 的說法。我們的獎酬方案(comp plans)現在更偏重於團隊所稱的 MVAC,也就是 Medicare、VA,以及已簽約的營收(contracted revenue)。已簽約的營收包含消防員以及自保型雇主(self-insured employers)。重點是確保能收得到錢。

  • And so when you look at the total of 2,800 tests in the quarter, just under 40% fit that category, and that's up substantially from the previous quarter. And the government insurance, which all include Medicare and Medicare Advantage, Medicaid, and TRICARE, and the VA is about half of that, and the direct contracting is the other half. And as Lishan said, the VA presently is not contributing to the test volume. The VA is more about obtaining purchase orders and pipeline building until the new budget year in October. Test volume from those PAs, from those purchase orders is forthcoming and that'll contribute to the mix.

    因此,當你看本季總計 2,800 次檢測時,其中接近 40% 符合那個類別,且相較上一季大幅提升。而政府保險部分——包含 Medicare 與 Medicare Advantage、Medicaid、TRICARE,以及 VA——大約占其中一半;直接簽約(direct contracting)則占另一半。如同 Lishan 所說,VA 目前尚未對檢測量做出貢獻。VA 目前更偏向取得採購訂單(purchase orders)與建立管線,直到 10 月新的預算年度開始。來自那些 PA、來自那些採購訂單的檢測量即將到來,並會對組成占比有所貢獻。

  • So that gives you a little bit more color in terms of the split on the volume, but it is increasing in terms of the concentration on the MVAC commercial efforts.

    所以這能讓你更清楚看到量的拆分,但就聚焦 MVAC 的商業推進而言,集中度確實正在提高。

  • Operator

    Operator

  • Mike, Needham.

    Mike,Needham。

  • Michael Matson - Analyst

    Michael Matson - Analyst

  • So I guess first, just on this cost-effectiveness model, I was wondering if there were any kind of metrics you could share there. I don't know if you were looking at things in terms of cost per quality-adjusted life year or something like that.

    那我想先問這個成本效益模型(cost-effectiveness model),我想知道你們是否能分享任何相關指標。我不確定你們是否會用每品質調整生命年成本(cost per quality-adjusted life year)之類的方式來看。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes. We don't -- we're not publicly -- we're not ready to disclose the public numbers. We're still wrapping up the final touches to the model, but it is a very sophisticated HEOR model. We have worked with Dr. Nick Shaheen, who's one of our close advisors. You guys may recall he's the lead author of the American College of Gastroenterology guidelines. And he also happens to have a lot of expertise in this type of model building.

    是的。我們不——我們目前還沒準備好公開披露相關數字。我們仍在完成模型的最後收尾,但這是一個非常成熟、精密的 HEOR 模型。我們與 Nick Shaheen 醫師合作,他是我們的親近顧問之一。各位可能記得,他是美國胃腸病學會(American College of Gastroenterology)指引的主要作者。而且他在這類模型建構方面也有相當多的專業。

  • And these are quite sophisticated models, kind of analyses that incorporate numerous variables, does modeling in a variety of scenarios. And their view is towards the long-term value across multiple parameters, as I mentioned, all the way from the detection of the precancerous conditions all the way through the patient journey and for those who develop cancer.

    而這些都是相當精密的模型與分析,會納入許多變數,並在多種情境下進行建模。他們的觀點是著眼於跨多個參數的長期價值,如我所提到的,從偵測癌前病變一路到患者旅程(patient journey),以及對於那些最終發展成癌症的患者。

  • So yes, one of the metrics will be what you mentioned, quality-adjusted years of life, but there's a lot of other details that come out of it. It's really designed to be the type of model that commercial payers can sink their teeth into. If you recall, we said this before, Medicare doesn't incorporate healthcare economics, but obviously the commercial payers do.

    所以是的,你提到的那個指標——品質調整生命年(quality-adjusted years of life)——會是其中之一,但還會產出很多其他細節。它的設計目的,確實是要成為商業支付方能深入評估、能「咬得動」的那種模型。如果你記得,我們之前說過,Medicare 不會納入醫療經濟學(healthcare economics),但商業支付方顯然會。

  • And demonstrating long-term cost-effectiveness, not just budget impact, but long-term cost-effectiveness is important -- will be important over the long term. So all I can say right now is that the initial results with regard to the cost-effectiveness of EsoGuard testing across that broad spectrum of parameters is looking quite good. And it's looking quite good across nearly all model scenarios that were modeled in this analysis.

    而且要證明長期的成本效益——不只是預算影響,而是長期成本效益——這一點很重要,而且從長期來看也將會很重要。所以我現在能說的是,關於在那一大範圍參數下進行 EsoGuard 檢測的成本效益,初步結果看起來相當不錯。而且在本次分析所建模的幾乎所有模型情境中,看起來都相當不錯。

  • So those results will be released shortly. They'll be submitted for publication. These models need to go through the peer review process and publication for them to have their greatest impact in our conversations with commercial payers.

    所以這些結果將很快公布。也會提交發表。這些模型需要經過同儕審查流程並發表,才能在我們與商業保險支付方的對話中產生最大的影響。

  • Michael Matson - Analyst

    Michael Matson - Analyst

  • Okay, got it, got it. And then just on curious where you're seeing test samples being taken. You know, has there been any kind of changes there? I mean, I guess what I'm asking about is like the PCPs versus the GIs versus your test centers.

    好的,了解,了解。另外我也好奇你們看到的採檢樣本是在哪裡取得的。你知道,那邊有沒有任何變化?我的意思是,我想問的是像是基層照護醫師(PCP)對比腸胃科醫師(GI)對比你們的檢測中心。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes, so I sort of hit this with Mark's question, but the – and Dennis elaborated on our efforts over the last couple of quarters to shift our incentive plans so that our volume starts to shift away from being heavily dominated by these firefighter health fair type events towards engagement with primary care physicians and with GIs in our more traditional model, which in our case includes what we've referred to as our satellite Lucid Test Center model, where our nursing team, our clinical services team, performs testing days at practices, primary care practices and GI practices as well as desired.

    是的,所以我在回答 Mark 的問題時有稍微提到,但——Dennis 也闡述了我們在過去幾個季度所做的努力:調整我們的獎酬方案,讓量能開始從以這類消防員健康園遊會式活動為主,轉向與基層照護醫師以及腸胃科醫師的互動,回到我們較傳統的模式;在我們的案例中,這也包含我們所稱的衛星 Lucid 檢測中心模式,由我們的護理團隊、臨床服務團隊在診所安排檢測日,視需要在基層照護診所與腸胃科診所進行檢測。

  • So yes, behind the scenes that shift is going well. It always will include both primary care and gastroenterologists. Both of those are targets for us, but the majority of patients are at the primary care physician. However, the GIs play a very important role, as a conduit towards their primary care referral patterns, but also within their four walls, within their practice of the GIs, there are patients that they are happy to adopt our technology. I know we can discuss that further if you'd like.

    所以是的,在幕後這個轉移進展得很順利。它一向都會同時包含基層照護與腸胃科醫師。這兩者都是我們的目標,但大多數病患是在基層照護醫師那裡。不過腸胃科醫師扮演非常重要的角色:一方面作為導管,影響其轉介到基層照護的模式;另一方面在他們自己的診所內部,也有一些病患,他們很樂於採用我們的技術。如果你願意,我知道我們可以再進一步討論。

  • In addition, as I wanted to emphasize the long effort -- long-term efforts over the last couple of years for us to engage with health systems and develop models for building programs within larger health systems that include incorporating the entirety of the primary care physician group, for example, in the health system, training them, incorporating the cell collection processes and all of the integration that's involved with EHR integration and system building and all of that. That's really starting to come to fruition and we're starting to lock down implementation and actually doing volumes and having these programs be active at multiple health systems.

    另外,我也想強調:過去幾年我們長期投入的努力,是與醫療體系合作,並在較大型的醫療體系內建立計畫的模式,例如把該醫療體系內整個基層照護醫師群納入、對他們進行訓練、導入細胞採集流程,以及所有與電子病歷(EHR)整合、系統建置等相關的整合工作。這些真的開始開花結果,我們也開始敲定導入落地,實際開始出量,並讓這些計畫在多個醫療體系中啟動運作。

  • Operator

    Operator

  • Anthony, Maxim Group.

    Anthony,Maxim Group。

  • Anthony Vendetti - Analyst

    Anthony Vendetti - Analyst

  • So in terms of the coverage policy from Concert, do we know the number of enrolled lives or covered lives under that, and what that potential is in terms of patients?

    那就 Concert 的承保政策而言,我們是否知道其投保人數或承保人數(covered lives),以及就病患數量而言的潛在規模?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes. So covered lives is always a bit of a tricky number. So we don't want to -- there's obviously complexities that underlie that with regards to the geographic distribution, the age distribution, the demographics, and so forth. But overall, the plan, again, the covered lives are not at the LBM level, right?

    是的。所以承保人數一向是個有點棘手的數字。因此我們不想——顯然其中有一些複雜性,涉及地理分布、年齡分布、人口統計特徵等等。但整體而言,該方案——再說一次,承保人數不是在 LBM 層級,對吧?

  • They're at the individual client health plans underneath the LBM. And the total number is about a bit under 10 million covered lives within the client health plans under Concert. As I said, those are – they are concentrated. They tend to be in the Midwest and the upper Midwest and the central Midwest. Those areas are dominant within there.

    而是在 LBM 之下的各個客戶健康保險計畫層級。在 Concert 旗下客戶健康計畫中的承保人數總計約略不到 1,000 萬。如我所說,這些——它們是集中分布的。主要集中在中西部、上中西部以及中部中西部。這些地區在其中占比最高。

  • So in terms of the potential, yes, it's a significant potential. And we are, as I mentioned, we are, because it's concentrated geographically, it gives us the ability to allocate resources, allocate our team. You know, our team has generally been concentrated in certain areas, and this gives us some directionality in terms of where to target our resources further.

    所以就潛在性而言,是的,這是相當可觀的潛在機會。而且如我提到的,因為它在地理上集中,讓我們能夠配置資源、配置我們的團隊。你知道,我們的團隊一般也集中在某些區域,而這也在我們進一步鎖定資源投放方向上提供了一些指引。

  • Anthony Vendetti - Analyst

    Anthony Vendetti - Analyst

  • Okay, and then just as a follow-up, has the number of denials of coverage for your product, has that started to trend down? Or is it just every quarter it's kind of, is sort of the process? And is there anything else that you're doing from your end to try to get those denials down? In terms of -- I know when there's a denial, you provide evidence of necessity and so forth, but is there anything else you can do from your end to prevent the denial from happening initially?

    好的,那再追問一下:你們產品的承保拒賠(denials of coverage)數量,是否已經開始呈現下降趨勢?還是說每一季都差不多,就是一個流程?另外你們這邊還有做什麼,試圖把拒賠降下來嗎?就——我知道當有拒賠時,你們會提供必要性證據等等,但你們這邊還能做什麼,來避免一開始就發生拒賠?

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • Yep, so it's choppy Anthony. And we give you a couple things that we can do when it requires additional medical information, we're doing things to provide that in advance. But some of the puzzling things which just point to as a placeholder until they get it into the network and in policy is medically not necessary. Well, every one of our patients meet all the guidelines that exist or a denial that's experimental or investigational.

    是的,這個狀況起伏不定,Anthony。我們可以做幾件事:當需要補充額外醫療資訊時,我們會提前提供。但有些令人困惑的情況是,他們只是先用一些理由當作占位,直到把它納入網絡與政策中,例如說「醫療上非必要」。但我們每一位病患都符合現有的所有指引;或者拒賠理由是「實驗性或研究性」。

  • Well, United and Cigna now have policies about their endoscopy that point to EsoGuard as a gating factor to approve an endoscopy. So that goes against it being experimental or investigational. It's just an indication it's placeholders. And it's just the continuing work of engagement, having the tools, clinical evidence, having the health economics, having the Medicare, all of those components help. And having an LBM like Concert now demonstrate coverage based upon clinical evidence is certainly a good indicator.

    但 United 和 Cigna 現在在他們的內視鏡政策中,都指出 EsoGuard 是核准內視鏡的一個把關因素。所以這與「實驗性或研究性」的說法相矛盾。這只是顯示那些理由是占位用的。而這就是持續投入互動工作的結果:具備工具、臨床證據、健康經濟學資料、Medicare(聯邦醫療保險)等;所有這些要素都有幫助。而且像 Concert 這樣的 LBM 現在能基於臨床證據來展現承保,當然是一個很好的指標。

  • Some of these pillars are starting to fall based upon claims data, appeals, providing engagement with all of the significant clinical evidence, and there'll be more of that. But as far as the denials, there's really no trends that we can make headway out of it.

    其中一些支柱正開始因為理賠資料、申訴(appeals)、以及提供所有重要臨床證據並持續互動而逐步瓦解,之後也會有更多進展。但就拒賠而言,確實沒有什麼趨勢讓我們能夠從中取得明顯突破。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • But just to emphasize something Dennis said, as you were sort of asking, we definitely sort of leave -- no stone left unturned with regard to our efforts to -- within our revenue cycle management process.

    不過我想強調 Dennis 說的一點:就像你在問的,我們在營收循環管理流程中,確實會——在我們的努力上不放過任何一個細節。

  • So Dennis mentioned a few of those being very aggressive about supplying the full medical records and full clinical evidence in advance, being meticulous about how the test requisition forms are filled out and to make sure that they have the appropriate coding and criteria and so forth, and even exploring situations where prior auth comes into place, working through the appeals process if it is just going way. We do all of that, but I think much of that is on the edges, right? At the end of the day, the only way to really flip this fundamentally is to start securing coverage policies and that's what we're doing.

    所以 Dennis 提到其中幾項:在需要時非常積極地提前提供完整病歷與完整臨床證據;在檢測申請單(test requisition forms)的填寫上非常嚴謹,確保有適當的編碼、條件與標準等;甚至在需要事前授權(prior auth)的情況下也會去探索,若真的一路走向拒賠,就透過申訴流程處理。我們都會做這些,但我認為很多都只是邊際改善,對吧?歸根結底,真正能從根本翻轉的方式,是開始取得承保政策,而這正是我們正在做的事。

  • Anthony Vendetti - Analyst

    Anthony Vendetti - Analyst

  • Yes, so it sounds like you're doing everything humanly possible. It's just the way the system works. Many years ago, I worked for an insurance company.

    是的,聽起來你已經把人力所及能做的都做了。這就是這個系統運作的方式。很多年前,我曾在一家保險公司工作。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • It's all about coverage.

    一切都取決於保障範圍。

  • Anthony Vendetti - Analyst

    Anthony Vendetti - Analyst

  • So what was the percent, approximately, of denials this quarter?

    那麼,本季拒賠的比例大約是多少?

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • I'm going back to my statistics that I put in the -- in my prepared remarks, and just give me a moment, here we'll get there. So in the second quarter of the year -- of the 2,800 tests, we've so far had about two-thirds of them that have been adjudicated. And out of the ones that were adjudicated, about a third resulted in a payment allowance.

    我回到我在——在我準備好的發言稿裡提到的統計數據,請稍等一下,我們馬上就會看到。所以在今年第二季——在2,800次檢測中,我們目前大約有三分之二已完成理賠審核(adjudicated)。而在已完成審核的部分中,大約三分之一最終獲得核准給付(payment allowance)。

  • Now, the allowance that I quoted of $1,424 is after deductibles and co-pays and that sort of thing. So it's bumping up with all of that components. It's out of network, predominantly. It bumps up against the Medicare rate. And of those denied, those three buckets, experimental or investigational was 18%, require prior authorization was 22%, or required some additional medical records was 5%. So that gives you some color in terms of the percentage in those couple of buckets.

    另外,我剛才提到的1,424美元核准金額,是在扣除自付額(deductibles)與共付額(co-pays)等之後的數字。所以它把所有這些組成項目都納入了。主要是屬於網外(out of network)。它會接近醫療保險(Medicare)的費率。而在被拒賠的案件中,那三個類別分別是:實驗性或研究性(experimental or investigational)占18%、需要事前授權(require prior authorization)占22%、或需要補充一些醫療紀錄占5%。因此,這能讓你對那幾個類別的比例有一些概念。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Can I just add one thing? Because your question really does help remind people about some of the complexities here. So the issue is not simply you don't have coverage or you don't have prior auth or some of the other flags that are brought up that lead to denials, even in situations where there's an allowable amount, if you are out of network, then the ability to collect on that, because of the portion that's under patient responsibility, is limited.

    我可以再補充一點嗎?因為你的問題確實有助於提醒大家這裡面的一些複雜性。所以問題不只是你沒有保障、或你沒有事前授權、或其他導致拒賠的標記;即便在有核准金額(allowable amount)的情況下,如果你是網外,那麼由於有一部分屬於病患責任(patient responsibility),能夠收回款項的能力就會受限。

  • So the importance of securing these coverage policies is not simply to have claims approved, but we're also going to get paid through them because the portion that's allocated to patient responsibility goes down dramatically. Does that make sense?

    因此,爭取並確保這些保障政策的重要性,不僅是讓理賠獲得核准,我們也能因此收到款項,因為分攤到病患責任的那一部分會大幅下降。這樣說有道理嗎?

  • Anthony Vendetti - Analyst

    Anthony Vendetti - Analyst

  • Right, right. See, as your network grows also, it lowers the denial rate.

    對,對。你看,隨著你的網絡也在擴大,也會降低拒賠率。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes, In-network.

    是的,網內(In-network)。

  • Anthony Vendetti - Analyst

    Anthony Vendetti - Analyst

  • I got you. Yes. Exactly. In-network.

    我懂了。是的。沒錯。網內(In-network)。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes. Being in network ultimately has the biggest impact on converting an allowed claim into revenue.

    是的。成為網內(in network)最終對於把已核准的理賠(allowed claim)轉化為營收的影響最大。

  • Operator

    Operator

  • Ed, Ascendant Capital.

    Ed,Ascendant Capital。

  • Edward Woo - Analyst

    Edward Woo - Analyst

  • Yes, congrats on all the progress. My question is on the $2,000 test reimbursement. Is there any opportunity to increase that going forward for factoring inflation?

    是的,恭喜你們取得所有進展。我的問題是關於2,000美元的檢測報銷。未來是否有機會因應通膨而提高?

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Look, at this point we're not really pushing for that. We're quite satisfied that that's a fair price. You know, our cost of goods or our marginal incremental cost of goods is relatively modest, and our focus is on adoption and on securing a coverage policy.

    你看,就目前而言我們並沒有真的在推動這件事。我們相當滿意這是一個合理的價格。你知道,我們的銷貨成本(cost of goods)或邊際增量銷貨成本相對不高,我們的重點在於採用率,以及爭取保障政策。

  • Operator

    Operator

  • Kyle, Canaccord.

    Kyle,Canaccord。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • So I just wanted to ask if there's any update on concierge medicine and kind of like unique ways of getting payment and maybe going forward, ways to kind of supplement non-coverage and the traditional ways of having coverage reimbursement.

    我想問一下,禮賓醫療(concierge medicine)方面是否有任何更新,以及一些獨特的收款方式;也許未來有沒有方法可以補足未覆蓋(non-coverage)以及傳統的保障報銷方式。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes as you're hinting at last year, we did explore the concierge medicine side of things and had some success, but we found that the hurdles were really quite high with regard to the resources that are required to convert a concierge practice into test volume as well as into payment.

    是的,正如你暗示的,我們去年確實探索過禮賓醫療這一塊,也取得了一些成功,但我們發現,要把禮賓診所轉化為檢測量以及轉化為收款,在所需資源方面的門檻其實相當高。

  • So our emphasis outside of the traditional pathways include sort of contracted events, whether it's contracted through fire departments and other entities as well as on the employer side, as well as what we mentioned, shifting our focus to MVAC. So ultimately, concierge is not a major emphasis for us. We just didn't see the payoff with regard to the resources that we were trying to allocate towards that.

    因此,除了傳統途徑之外,我們的重點包括某種形式的合約型專案,不論是與消防部門及其他機構簽約的專案,以及雇主端(employer side),還有我們提到的,把重心轉向MVAC。所以總體而言,禮賓醫療並不是我們的主要重點。就我們原本想投入的資源而言,我們沒有看到相應的回報。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • Got it. And when you think about hiring new reps, what industries would make sense for them to come from? I mean, how do you think about hiring from pharma or MedTech? I just feel like that's going to be a --

    了解。那你們在考慮招募新的業務代表時,哪些產業背景會比較合適?我的意思是,你們怎麼看從製藥或醫療科技(MedTech)招募?我只是覺得那會是一個--

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes. We've had a lot of experience with that. Yes, sorry to interrupt. We've had a lot of experience with that over now, five or six years, and we have really honed our internal expertise and skill set with regard to recruiting and training and demonstrating what types of individuals with regard to their background fit well in certain -- within the hierarchy of the sales team.

    是的。我們在這方面有很多經驗。是的,抱歉打斷一下。我們在過去五、六年累積了很多經驗,也確實打磨出我們在招募、訓練,以及判斷不同背景的人才在某些——在銷售團隊層級架構中哪些位置更適配——方面的內部專業與技能組合。

  • It actually includes sort of all of the above, that we've had good success getting sort of younger early stage, early career folks out in the field as long as they're well trained in engaging directly with physicians. But certainly on the sales leadership side at the district and regional and national level, having folks who have experience. Many of them have experience within GI, within GI diagnostics.

    其實幾乎各種背景都包含在內;只要在與醫師直接互動方面受過良好訓練,我們在外勤端招募較年輕、職涯早期的人才也有不錯的成果。但當然,在區域、地區以及全國層級的銷售領導職位上,擁有經驗的人才很重要。其中很多人有GI(腸胃科)領域、GI診斷方面的經驗。

  • So it's a bit of a mix, but our experience over the last couple of years is really – At the end of the day, let me just emphasize one other thing, sorry, Kyle, which is that it all still ultimately comes down to training. And our training program, our team that does sales training, has gotten really quite sophisticated.

    所以會是一種混合,但我們過去幾年的經驗其實是——歸根結底,我再強調一點,抱歉,Kyle,那就是最終仍然取決於訓練。而我們的訓練計畫、負責銷售訓練的團隊,已經變得相當成熟。

  • And the most recent updates to our programs include AI, include AI-based role playing, handling -- objection handling by physicians and sort of the ability to train folks to engage and tell our story and tell our message as they interact with physicians has gotten quite a bit more sophisticated. So backgrounds matter. It's diverse, as I mentioned, but what really translates into effectiveness in the field is converting that experience into sales training.

    我們最近對課程的更新包含AI,也包含以AI為基礎的角色扮演,處理——處理醫師的異議(objection handling);以及訓練同仁在與醫師互動時能夠溝通、講好我們的故事與訊息的能力,都變得更為成熟。所以背景確實重要。如我所說,它是多元的,但真正能轉化為前線成效的,是把那些經驗轉換成銷售訓練。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • Okay. And it's been -- it's obviously offering the test. I'm just curious if you've already kind of unlocked most of the COGS, the cost of goods sold savings over the years, or if there's some sort of automation or like any next-gen versions that you can kind of do that with, and maybe talk about what a COGS process could look like over the long term.

    好的。而且一直以來——顯然是在提供這項檢測。我只是好奇,你們是否多年來已經把大部分COGS(銷貨成本)的節省都釋放出來了,或者是否還有某種自動化、或任何下一代版本可以做到;也許談談長期來看COGS流程可能會是什麼樣子。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yep, at our current volumes, we've really spent a lot of time honing our SOPs and the entire underlying processes for the assay, and it is really quite efficient. We continue to improve on that. We have new AI-based tools for requisitions for as samples come in. So there are still some improvements that we're able to extract, but we're really quite efficient.

    是的,以我們目前的量體來看,我們確實花了很多時間打磨我們的SOP,以及這項檢測(assay)背後的整套流程,效率其實相當高。我們仍在持續改進。我們有新的AI工具用於申請單(requisitions)以及樣本送達時的處理。所以我們仍能再榨取一些改善空間,但整體而言我們已經相當有效率。

  • But as you hinted, clearly as volume grows and we are at higher levels of volume, there are multiple opportunities to incorporate further technological advances to improve efficiencies, and much of that centers around automation. So there are plenty of opportunities for that. I don't know, Dennis, do you want to comment on how that would affect the cost of goods versus --

    但正如你所暗示的,顯然隨著量能成長、且我們處於更高的量能水準時,會有多個機會導入進一步的技術進展以提升效率,而其中很大一部分聚焦在自動化上。所以這方面有很多機會。我不確定,Dennis,你想評論一下這會如何影響銷貨成本相較於--

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • Yes, just to give you a sense, presently the EsoCheck device costs around $60, and to process a test through the lab is about $125 or so. We see the cost of the lab coming down marginally, and as you produce at a higher volume or the EsoCheck devices that will come down as well. Is there another $50 in there likely?

    是的,先讓你有個概念,目前 EsoCheck 裝置成本大約是 60 美元,而在實驗室處理一次檢測大約是 125 美元左右。我們看到實驗室成本會小幅下降,而當你以更高的量生產 EsoCheck 裝置時,成本也會下降。那裡面有可能再降 50 美元嗎?

  • How much further you can push down. You're talking about incremental amounts of 90% margins on the overall test. So adoption and price preservation are probably more important to margin profitability than trying to squeeze the profit, although they're doing everything they can. And as Lishan said, automation will certainly help with that.

    你還能把它壓低多少。你談的是整體檢測約 90% 毛利率下的增量金額。因此,相較於試圖擠壓利潤,採用率與價格維持可能對毛利獲利能力更重要,儘管他們正盡其所能。而且如 Lishan 所說,自動化肯定會有所幫助。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • All right. And are there any other levers to reduce cash burn in the near term? I guess, I mean, obviously maybe the revenue influx would help offset that, but anything else we can think about as we model out kind of your burn going forward and cash needs and things like that?

    好的。那麼在短期內,還有其他槓桿可以降低現金消耗嗎?我的意思是,顯然也許營收流入會有助於抵消,但在我們建模你們未來的消耗、現金需求等方面,還有其他我們可以考量的嗎?

  • Dennis McGrath - Chief Financial Officer

    Dennis McGrath - Chief Financial Officer

  • Well, as you do kind of a look backwards, the burn is pretty flat at $11.3 million. A good chunk of that is in commercial and clinical services and clinical evidence. And as we have indicated that we need to stay in that 2,500 to 3,000 test band at a minimum just to stay relevant with chief medical officers.

    嗯,如果你回頭看,現金消耗大致持平在 1,130 萬美元。其中相當大一部分在商業與臨床服務以及臨床證據。而且我們已指出,至少必須維持在 2,500 到 3,000 次檢測的區間,才能在首席醫療官那裡保持相關性。

  • You have to file claims, you have to file appeals. If you don't have test volume, then you're just not going to be thought about. So when we look at that mix and trying to balance level of test volume to achieve those endpoints versus growth without getting paid, it just makes sense to try and preserve that.

    你必須提交理賠,你必須提出申訴。如果沒有檢測量,就不會有人把你放在心上。所以當我們看這個組合,並試圖在達成那些終點所需的檢測量水準與在未收款情況下的成長之間取得平衡時,維持這樣做是合理的。

  • To cut the cash burn further, we would have to cut into some of the commercial activities, and that just doesn't make sense at this point, being in this, I'll call it zone of Medicare and gearing up for that.

    若要進一步降低現金消耗,我們就必須削減部分商業活動,而在目前這個階段——我稱之為 Medicare 的區域、並為此做準備——這樣做並不合理。

  • As we move forward, one of the comments we made earlier in this call is that with the test price at $2,000 and a margin of 90%, increasing our commercial activities with our headcount programs, and both are relevant in terms of increasing speed of adoption, you can do so without the normal significant burn, because the payment cycle on the margin will help cut down what a lot of early stage companies have to suffer through an increasing burn and consumption of capital during their growth phase. And that's a tailwind for us that's very beneficial.

    展望未來,我們在本次電話會議稍早提到的一點是:在檢測價格為 2,000 美元且毛利率為 90% 的情況下,增加我們的商業活動與人力配置方案——兩者都與提升採用速度相關——你可以在不產生一般情況下那種顯著消耗的前提下做到,因為毛利的收款週期將有助於降低許多早期公司在成長階段必須承受的、隨成長而增加的消耗與資本耗用。這對我們而言是一股非常有利的順風。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Yes, and just maybe to emphasize one other thing, I think really our best opportunity to lower our cash burn is to just drive revenue. And as you note, our revenue was up a modest amount this quarter, despite the volume remaining flat or even slightly down from quarter to quarter. So that really is where the near-term opportunity lies, is realizing revenue through the VA, through increasing contracted events, as well as by securing some of these commercial plans as we wait on Medicare.

    是的,再強調一點,我認為我們降低現金消耗的最佳機會,確實就是推動營收。如你所指出,本季我們的營收小幅成長,儘管檢測量維持持平,甚至較上一季略有下降。因此,短期機會就在這裡:透過 VA、透過增加已簽約的活動,以及在等待 Medicare 的同時拿下一些商業保險計畫,來實現營收。

  • Operator

    Operator

  • Ladies and gentlemen, that concludes today's Q&A session. I will turn the call back over to Dr. Lishan Aklog.

    各位女士先生,今天的問答環節到此結束。我將把電話會議交回給 Lishan Aklog 醫師。

  • Lishan Aklog - Chairman and Chief Executive Officer

    Lishan Aklog - Chairman and Chief Executive Officer

  • Great. Thanks, operator, and thank you all for taking the time and for your attention this morning. As always, great questions from our analysts. I hope you found the discussions informative. Just really to summarize, we do remain confident that a positive Medicare draft LCD is forthcoming, and we're encouraged by some of the signs that the LCD backlog may be loosening.

    很好。謝謝主持人,也謝謝各位今天早上撥冗參與並專注聆聽。一如既往,我們的分析師提出了很棒的問題。希望你們覺得這些討論很有資訊量。簡要總結一下,我們仍然有信心,正面的 Medicare LCD 草案即將出爐,而且我們也受到一些跡象鼓舞,顯示 LCD 的積壓可能正在鬆動。

  • But meanwhile, we're happy with the progress we're making on multiple fronts. As we've discussed repeatedly during this call, the first off, the coverage policy is really important, really solid progress on the VA. This new fiscal year will be really important in terms of us securing longer-term contracts within the upcoming budget. Our engagement with health systems and the ability to use the EHR integration within health systems to drive success in those programs is great.

    但同時,我們對於在多個面向取得的進展感到滿意。如我們在本次電話會議中反覆討論的,首先,給付範圍政策非常重要;在 VA 方面也取得了非常扎實的進展。這個新的會計年度將非常關鍵,關係到我們在即將到來的預算中取得較長期合約。我們與醫療體系的互動,以及在醫療體系內運用 EHR 整合來推動這些專案成功的能力,都非常好。

  • And again, it's a bit obscure, but our efforts on the healthcare economic side is extremely important. It is a very important milestone coming up. And it'll certainly over the long term will have a significant impact. All of this activity has been really important in sort of increasing our visibility and sort of our opportunities for broader strategic engagements, which is exciting.

    再者,雖然有點不那麼顯眼,但我們在醫療經濟學方面的努力極其重要。一個非常重要的里程碑即將到來。而且從長期來看,它肯定會產生重大影響。所有這些活動對於提升我們的能見度,以及增加我們進行更廣泛策略性合作的機會,都非常重要,令人振奮。

  • So thanks again. As always, we encourage you to keep abreast of our progress. Please follow our news releases, these update calls, our website, social media. And as always, feel free to reach out to us if you have any questions. So thanks, everybody, and have a great day.

    再次感謝。一如既往,我們鼓勵各位持續關注我們的進展。請追蹤我們的新聞稿、這些更新電話會議、我們的網站與社群媒體。也一如既往,如果你有任何問題,歡迎隨時與我們聯繫。謝謝大家,祝各位有美好的一天。

  • Operator

    Operator

  • Ladies and gentlemen, this has concluded today's conference call. Thank you for participating. You may now disconnect.

    各位女士先生,今天的電話會議到此結束。感謝各位參與。您現在可以掛線。