Lucid Diagnostics Inc (LUCD) 2026 Q1 法說會逐字稿

Good morning, and welcome to the Lucid Diagnostics first quarter 2026 business update conference call. Please note that this event is being recorded.

早安，歡迎參加 Lucid Diagnostics 2026 年第一季業務更新電話會議。請注意，本活動將被錄音。

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。

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 of Lucid Diagnostics.

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 Lucid Diagnostics 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 and forward-looking statements in the press release. The business update press release and the 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的免責聲明與前瞻性陳述。業務更新新聞稿與本次電話會議皆包含前瞻性陳述，而這些前瞻性陳述受到已知與未知風險及不確定性的影響，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 with the SEC. For a list and 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 the 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。關於可能影響未來營運之這些及其他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 年度報告中第一部分第 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 the expectations may be based or that may affect the likelihood that actual results would 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，或反映可能作為該等預期基礎之事件、狀況或情勢的變化，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, Chairman and CEO of Lucid Diagnostics.

現在我想把電話會議交給 Lucid Diagnostics 董事長兼執行長 Lishan Aklog 醫師。

Thank you, Matt, and good morning, everyone. Thank you for joining us today and for your continued engagement and support. Let's begin with some key highlights from the first quarter and recently. We performed 3,177 EsoGuard tests in the first quarter of this year and this generated revenue of $1.3 million. The revenue was down slightly, but proportional to volume, which receded a bit but remained above our target range of 2,500 to 3,000 tests and preserving our average sale price.

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。我們先從第一季及近期的一些重點開始。今年第一季我們完成了 3,177 次 EsoGuard 檢測，帶來 130 萬美元營收。營收略有下降，但與檢測量成比例；檢測量雖稍有回落，但仍高於我們 2,500 至 3,000 次的目標區間，且維持了我們的平均售價。

We also importantly strengthened our balance sheet with an underwritten public offering of common stock that had approximately $16.8 million in proceeds. This significantly bolstered our balance sheet, as Dennis will describe in more detail, to approximately $45 million in pro forma cash at the end of Q1. This extends our runway well into 2027, where we're encouraged by the participation of long-term institutional investors exhibiting confidence in our strategic opportunities. This also mitigated the financing overhang and provides us with the resources that we'll need to accelerate commercial efforts after we receive Medicare approval.

我們也透過承銷的普通股公開發行，取得約 1,680 萬美元的募資款項，重要地強化了資產負債表。正如 Dennis 將更詳細說明，這使我們在第一季末的備考現金約達 4,500 萬美元，顯著提升了資產負債表。這將我們的資金可用期延伸至 2027 年的相當一段時間；我們也很受鼓舞，因為長期機構投資人參與其中，展現對我們策略性機會的信心。此舉亦降低了融資不確定性的壓力，並為我們在取得 Medicare 核准後加速商業化推進提供所需資源。

Another important highlight from this quarter is that we had a very successful Digestive Diseases Week or DDW. This is the major GI meeting, major annual meeting of gastroenterologists under the auspices of the American Gastroenterologic Association, the AGA. We had multiple abstracts related to EsoGuard and EsoCheck and had an excellent opportunity for multiple team members to have extensive engagements with the GI community.

本季另一項重要亮點是我們在 Digestive Diseases Week（DDW，消化疾病週）取得非常成功的成果。這是主要的腸胃科（GI）年度會議，由美國胃腸病學會（American Gastroenterologic Association，AGA）主辦。我們提交了多篇與 EsoGuard 與 EsoCheck 相關的摘要，也讓多位團隊成員有極佳機會與腸胃科社群進行深入交流。

One very important highlight from this meeting was the AGA presented a draft update of their clinical practice guidelines for Barrett's Esophagus for esophageal precancer. This draft was extremely positive for EsoGuard and EsoCheck. It highlighted by name, EsoGuard and EsoCheck as an alternative to endoscopy for esophageal precancer screening and it explicitly highlighted EsoGuard and EsoCheck as being superior to other pre-commercial technologies, garnering the highest certainty of evidence compared to lower bars for the others. This is a draft, but we do expect the formal guideline publication or formal communication is to come from the AGA in the near future.

本次會議的一項非常重要亮點是，AGA 發布了其針對巴瑞特食道（Barrett's Esophagus）／食道癌前病變之臨床實務指引的更新草案。該草案對 EsoGuard 與 EsoCheck 極為正面。草案中點名將 EsoGuard 與 EsoCheck 列為食道癌前病變篩檢中可替代內視鏡的選項，並明確指出，相較於其他尚未商業化的技術，EsoGuard 與 EsoCheck 證據確定性最高，而其他技術的證據門檻較低。這目前仍是草案，但我們預期 AGA 將在不久的將來正式發布指引或進行正式溝通。

Before turning it over to Dennis, let's provide some updates related with a focus on our market access and commercialization efforts. So a lot going on here, a lot to cover. We'll review our Medicare -- the status of our Medicare approval, the VA, our engagement with laboratory benefit managers, commercial payers and health systems.

在交給 Dennis 之前，我們先就市場准入與商業化推進提供一些更新。這部分進展很多、內容也很多。我們將回顧 Medicare 的狀態（即 Medicare 核准進度）、退伍軍人事務部（VA）、我們與實驗室福利管理機構（laboratory benefit managers）、商業保險支付方以及醫療體系的互動。

So on Medicare, we continue to await the draft publication of the draft local coverage determination following our request for reconsideration. As with everybody, we're a bit frustrated by the delays we'd expect it to hear sooner, but we remain very confident that it's close and that we will get the draft publication consistent with our request in the near term following the successful public meeting that was held in September of last year.

在 Medicare 方面，我們仍在等待在提出重新審議（reconsideration）申請後，草案地方給付決定（draft local coverage determination）的草案公告發布。和大家一樣，我們對延遲感到有些挫折，原本預期會更早聽到消息；但我們仍非常有信心進度已接近完成，並且在去年 9 月成功舉行的公開會議之後，我們將在近期看到與我們申請內容一致的草案公告發布。

We continue to have ongoing engagement with leadership and other folks who are engaged in this space, and there clearly remain logistical delays with regard to putting out local coverage determinations remain, and we have expectations that, that will pick up in the near future, and that will be among them.

我們持續與相關領導層及其他在此領域投入的人士保持互動；顯然在發布地方給付決定方面仍存在行政與作業上的延宕。我們預期這些進度在不久的將來會加快，而我們的案件也將包含在其中。

Lots of progress on the VA side as well. As we noted in our last meeting, we received our -- the federal supply schedule with payment consistent with our Medicare payment. And our team is now deeply engaged with the VA across the entire commercial team led by our strategic accounts Director for the VA. We have multiple engagements, have a very deep pipeline of dozens of centers and some of these early engagements are starting to bear fruit.

在 VA 方面也有許多進展。如同我們在上次會議提到的，我們已取得聯邦供應時程（federal supply schedule），其支付水準與我們的 Medicare 支付一致。目前我們的團隊正由負責 VA 的策略客戶總監帶領，整個商業團隊深入與 VA 展開合作。我們有多項互動，建立了涵蓋數十個中心的深度管線，其中一些早期互動已開始產生成果。

Our first orders were placed. Our first testing will begin in the coming weeks. And we are continuing to navigate budgeting and the workflows around cell collection at each of these individual VA centers. The budgeting process is on the government fiscal year. We do expect to get orders within this fiscal year. The major opportunity is the opportunity is to really accelerate volume and revenue will happen in the new fiscal year when we're part of the new budgetary process for the new fiscal year.

我們已收到第一批訂單，並將在未來幾週開始首次檢測。我們也持續在各個 VA 中心就預算編列與細胞採集流程的作業方式進行協調。預算流程依政府會計年度運作；我們預期在本會計年度內可取得訂單。最大的機會在於，當我們納入新會計年度的新預算流程時，將能在新會計年度真正加速檢測量與營收。

So we're looking forward to demonstrating EsoGuard's role across the VA. There's lots of opportunities. The story here is quite powerful that many VAs have -- are limited in their resources and the opportunity to avoid unnecessary endoscopies by triaging patients to EGD only upon a positive EsoGuard test is very attractive to both the clinical team as well as the centers as a whole. And many VAs operate via satellite VAs that are quite remote from the main centers and EsoGuard is a very attractive option to avoid patients having to travel for EGD if they have a negative EsoGuard test.

因此，我們期待在 VA 體系中展現 EsoGuard 的角色。這裡有很多機會。其核心論述相當有力：許多 VA 的資源有限，若能透過僅在 EsoGuard 檢測呈陽性時才將病患分流至 EGD（上消化道內視鏡檢查），以避免不必要的內視鏡檢查，對臨床團隊以及各中心整體而言都非常具吸引力。此外，許多 VA 透過衛星 VA 據點運作，這些據點距離主要中心相當偏遠；若病患 EsoGuard 檢測為陰性，EsoGuard 便是避免病患為了 EGD 而長途奔波的極具吸引力選項。

So overall, lots of activity here. We're seeing progress. We look forward to further engagement across the entire VA system in the coming quarters. We discussed in our last call, we continue to have active engagements on the commercial side, the commercial payer side with laboratory benefit managers. We've had active discussions with some of the largest ones. As we noted last time, we have secured positive coverage from one of the local benefit managers that we have confirmation of that, that's not public yet.

整體而言，這裡活動非常多，我們也看到進展。未來幾季我們期待在整個 VA 系統中進一步深化互動。如同我們在上次電話會議中提到的，在商業端、也就是商業支付方端，我們仍持續與實驗室福利管理機構保持積極互動，並已與其中一些最大型機構進行深入討論。正如上次所述，我們已從其中一家地方性福利管理機構取得正向給付涵蓋（positive coverage），且我們已獲得確認，但目前尚未對外公開。

And we are in discussions with the individual plans that outsource their coverage policy making to this LBM and are encouraged by the feedback that we've received on that. As we also discussed in the last call, we've had -- we continue to have direct engagements with certain of the larger commercial payers and particularly exciting avenue for that is leveraging existing endoscopy policies that highlight EsoGuard as an appropriate triage test to triage patients to endoscopy. Those discussions continue to make progress towards credentialing and contracting in the near future, and we'll report further once those are secured.

我們也正與將其給付政策制定外包給該 LBM 的個別保險計畫進行討論，並對所收到的回饋感到鼓舞。另如同上次電話會議所提到的，我們已經——並且持續——直接與部分較大型的商業支付方進行互動；其中一個特別令人振奮的途徑，是利用既有的內視鏡相關政策，將 EsoGuard 列為適當的分流檢測，用於將病患分流至內視鏡檢查。這些討論持續推進，朝近期完成資格認證（credentialing）與簽約（contracting）邁進；待相關事項確定後，我們將再進一步對外報告。

In addition, we have a lot of activity going on across health systems across the country. Part of this is in anticipation of getting Medicare, and there's lots of structural activities that are going into that. We've discussed a bit on our last call about the process for EHR integration that allows -- that provides ease of use by the physicians in terms of ordering as well as reviewing reports all within the same workflow.

此外，我們在全國各地的醫療體系中也有大量工作正在推進。其中一部分是為了預期取得 Medicare（聯邦醫療保險）給付，並且有許多結構性工作正在進行。我們在上次電話會議中也稍微討論過 EHR（電子病歷）整合的流程；該整合可讓醫師在同一工作流程中更方便地下單以及檢視報告。

We have activity across multiple sites towards this and this activity with EHR integration. As is common across the entire diagnostic industry, we know it helps drive productivity by the commercial team. We also have some active projects on coding, both the CPT code for the performance of the EsoCheck procedure and an ICD-10 code for patients who are undergoing endoscopy who had a positive EsoGuard test.

我們在多個據點都在推動這項工作與 EHR 整合。正如整個診斷產業普遍情況，我們知道這有助於商業團隊提升生產力。我們也在編碼方面推進一些專案，包括 EsoCheck 程序執行的 CPT 代碼，以及針對接受內視鏡檢查且 EsoGuard 檢測結果為陽性的患者之 ICD-10 代碼。

Both of these are extremely helpful with billing and medical necessity. But especially for the health care systems, having this code, particularly the CPT code is important for them to be able to track test and track patients as they move through the system. And we expect the CPT milestone to be in the near term. We've been able to secure strong support by -- from the professional societies in helping us go about securing this code.

這兩者對於帳單申報與醫療必要性判定都極為有幫助。但特別是對醫療體系而言，擁有這些代碼（尤其是 CPT 代碼）很重要，因為他們能夠追蹤檢測並追蹤患者在體系內的流轉。我們預期 CPT 的里程碑將在近期達成。我們也已獲得專業學會的強力支持，協助我們取得該代碼。

And finally, as it relates to the commercial payers, unlike Medicare, health care economics plays an important role in our ability to engage with medical directors and secure coverage policy. And so we've been actively working to expand our portfolio of data, health care economic data that demonstrates the cost effectiveness of EsoGuard testing as an alternative to endoscopy. That work is going extremely well.

最後，關於商業保險支付方（commercial payers），不同於 Medicare，醫療經濟學在我們與醫療主任（medical directors）互動並取得給付政策方面扮演重要角色。因此，我們一直積極擴充資料組合，特別是醫療經濟學資料，以證明 EsoGuard 檢測作為內視鏡替代方案的成本效益。這項工作進展非常順利。

Early drafts of the very sophisticated modeling -- that economic modeling that goes into that, that is required by any payers is well underway. And the ultimate outcome of this will be a peer-reviewed publication that demonstrate the health care economic value of EsoGuard.

目前，所需的高階模型（即支付方要求的經濟模型）之初稿已在積極推進中。最終成果將是一篇同儕審查（peer-reviewed）論文，用以證明 EsoGuard 的醫療經濟價值。

So overall, in summary, a lots going on, particularly on the market access and the commercial side. Obviously, all focus is on Medicare, and we acknowledge joint frustration of some of the delays within the Medicare LCD process.

總體而言，簡要總結：目前有很多事情在進行中，尤其是在市場准入與商業端。顯然，所有重點都放在 Medicare 上，我們也理解並認同大家對 Medicare LCD（地方給付決定）流程中部分延遲的共同挫折感。

Overall, we believe this is really at the end of the day, systematic, and we continue to have our confidence that this is the near-term results really hasn't wavered at all. But as we've discussed before, we're not idle as we're awaiting Medicare. The commercial team continues to drive its activities to drive patients to increase the proportion of our patients that are Medicare.

整體來看，我們相信這終究是系統性的流程，我們對於近期結果的信心完全沒有動搖。但如同先前所述，在等待 Medicare 期間我們並未停滯；商業團隊持續推動各項活動，以帶動患者量並提高我們患者中 Medicare 受益人的占比。

The VA activities are really off to a good start, strong engagements with our early targets of the VA centers, and we hope to be starting testing and generating revenue from that in the very near future. And in addition, as I already outlined, lots of activity that allows us to aggressively build the infrastructure necessary to accelerate our health care system adoption, EHR, coding, health care economics and such and our direct engagements with multiple health systems across the country continues to accelerate, and we think will accelerate further once we secure Medicare coverage.

VA（退伍軍人事務部）相關工作確實有了良好開端，與我們早期鎖定的 VA 中心目標互動強勁；我們希望在不久的將來開始檢測並由此產生營收。此外，如我先前所概述，還有大量工作使我們能積極建置必要的基礎設施，以加速醫療體系採用：EHR、編碼、醫療經濟學等；我們與全國多個醫療體系的直接接洽也持續加速，我們認為一旦取得 Medicare 給付，這一進程將進一步加快。

So with that, I'll let Dennis take over and provide an update on our financials.

那麼，接下來我把時間交給 Dennis，請他更新我們的財務狀況。

Thanks, Lishan, and good morning, everyone. The summary financial results for the first quarter were reported in our press release that has been distributed.

謝謝你，Lishan，各位早安。第一季的財務結果摘要已在我們已發布的新聞稿中揭露。

On the next 3 slides, I'll emphasize a few key financial highlights from the first quarter, but I'd encourage you to consider these remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q. With regard to the balance sheet, cash at quarter end March 31 was $27.9 million.

接下來 3 張投影片，我會強調第一季幾項關鍵財務重點，但也建議各位在閱讀這些說明時，搭配我們 Form 10-Q 季報中的完整揭露一併理解。就資產負債表而言，截至 3 月 31 日季末現金為 2,790 萬美元。

On a pro forma basis, including the recent April 24 financing, pro forma cash equals $44.8 million. The average burn rate for the last four quarters included cash interest on the debt was $11.3 million per quarter with the first quarter a bit higher at $12.1 million as we made investments in our commercial teams, including sales, clinical services and market access.

以備考（pro forma）基礎計入 4 月 24 日近期融資後，備考現金為 4,480 萬美元。過去四個季度的平均現金消耗率（包含債務現金利息）為每季 1,130 萬美元；第一季略高，為 1,210 萬美元，因為我們對商業團隊進行投資，包括銷售、臨床服務與市場准入。

You'll recall at the end of 2024, we refinanced our convertible debt into a $22 million five-year note, interest only at 12% with a $1 conversion price, which is held by long-term shareholders. The fair value of the convertible notes in the amount of $25.2 million at quarter end is really the only other substantive change from the previously reported balances at the end of the fourth quarter. The fair value increase of $1.2 million in the quarter reflects a mark-to-market quarterly adjustment in parallel with the common stock price changes between the periods.

各位會記得在 2024 年底，我們將可轉換債務再融資為一筆 2,200 萬美元、五年期票據，12% 僅付息（interest only），轉換價格為 1 美元，且由長期股東持有。截至季末，可轉換票據的公允價值為 2,520 萬美元，這基本上是相較於第四季末先前揭露餘額的唯一其他重大變動。本季公允價值增加 120 萬美元，反映的是依市價（mark-to-market）的季度調整，與期間普通股股價變動同步。

The fair value increase is also a substantial part of the first quarter expense charge of $1.9 million reflected in other income in the P&L. Shares outstanding, including unvested RSAs and conversion of the remainder of the preferred shares as of last week are approximately 203 million.

公允價值增加也是第一季在損益表「其他收入」中反映之 190 萬美元費用（expense charge）的重要組成部分。流通在外股數方面，包含未歸屬（unvested）的 RSA 以及上週剩餘優先股的轉換後，約為 2.03 億股。

After the conversion of the Series B1 preferred shares on May 6, there was approximately 22.3 million common shares held in advance due to the 4.99% ownership blockers in the Series B and B1 certificate of designation. If these abeyance shares had been issued, common shares outstanding would be about 225 million. The GAAP outstanding shares as of March 31 of 164.9 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q.

在 5 月 6 日 Series B1 優先股轉換後，由於 Series B 與 B1 指定條款（certificate of designation）中的 4.99% 持股上限（ownership blockers），約有 2,230 萬股普通股暫緩發行（held in abeyance）。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。依 GAAP 計算，截至 3 月 31 日的流通在外股數為 1.649 億股，投影片上以及 10-Q 資產負債表表面亦有反映。

GAAP shares do not reflect unvested RSA amounts. There are no longer any preferred shares outstanding. 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, PAVmed together with the Board and management still have considerable influence over Lucid with approximately 25% voting interest.

GAAP 股數不包含未歸屬的 RSA 數量。目前已不再有任何優先股流通在外。現階段，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 PAVmed 與董事會及管理層合計仍對 Lucid 具有相當影響力，約有 25% 的表決權益。

Next slide. With regards to the P&L, this slide compares this year's first quarter to last year's first quarter. I trust you'll review the information in my comments in light of the cautionary disclosure at the bottom of the slide about supplemental information, particularly non-GAAP information.

下一張投影片。就損益表而言，本張投影片比較今年第一季與去年第一季。我相信各位會在閱讀我的說明時，同時留意投影片底部關於補充資訊（尤其是非 GAAP 資訊）的警示性揭露。

As Lishan mentioned, our sales team sold almost 3,200 tests for the first quarter with a billable value over $8.7 million, resulting in recognized revenue of $1.3 million. The test volume is above the upper end of the range that we've been targeting in this pre-Medicare time period. The fourth quarter sequential comparative period of 3,664 tests had an unusually high number of one-time firefighter testing events towards the end of the period, which pushed last quarter's target range well above the norm.

如 Lishan 所提，我們的銷售團隊在第一季售出將近 3,200 份檢測，計費價值（billable value）超過 870 萬美元，因而確認營收 130 萬美元。檢測量高於我們在 Medicare 核准前期間所設定目標區間的上緣。第四季的連續比較期間為 3,664 份檢測，但該季度末有異常大量的一次性消防員檢測活動，將上季的目標區間推高至高於常態的水準。

With new investors once again joining us for this call, it's worth repeating what we've communicated in the past quarters about revenue recognition. A key determinant how revenue is recognized at least at this point in the reimbursement journey is the probability of collection.

由於本次電話會議再次有新投資人加入，因此值得重申我們在過去幾季已溝通過的營收認列方式。在目前的給付（reimbursement）進程階段，決定營收如何認列的關鍵因素之一，是收款的可能性（probability of collection）。

And therefore, due to the fact that we are in this transitional stages of our reimbursement process means revenue recognition for the majority of our claims submitted to traditional government or private health insurers will be recognized when the claim is actually collected versus when the patient report is delivered, invoiced and submitted for reimbursement.

因此，鑑於我們正處於給付流程的過渡階段，代表我們向傳統政府或民間健康保險公司提交的大多數理賠（claims），其營收將在實際收款時認列，而不是在患者報告交付、開立發票並提交申請給付時認列。

As you'll see in our 10-Q, this is called variable consideration in the jargon of GAAP 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 report is delivered to the referring physician.

如各位在 10-Q 中所見，依 GAAP ASC 606 營收認列準則的術語，這稱為「可變對價」（variable consideration）。而目前仍缺乏足夠的可預測資料，使我們能在檢測報告交付給轉介醫師時，就將季度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 is important to note that a pending Medicare approval decision impacts about 40% to 50% of our addressable patient population and therefore, will have a significant impact on our future revenue recognition analysis.

對於直接與雇主簽約的可計費金額（包含 VA），若金額固定且可確定（fixed and determinable），則會在我們交付合約服務時認列為營收。一般而言，這表示在報告交付給轉介醫師時認列。需要注意的是，尚待決的 Medicare 核准決策影響約 40% 至 50% 的可觸及患者族群，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 the final positive Medicare policy will also get paid within a reasonable time frame after the policy is issued. And that's generally $2 million to $3 million of revenue opportunity that will build once we have final Medicare approval.

此外，對於在最終正向的 Medicare 政策發布前 12 個月內、服務日期落在該期間的 Medicare 病患所進行的檢測，也將在政策發布後的合理時間內獲得給付。而一旦我們取得最終的 Medicare 核准，這通常代表約 200 萬至 300 萬美元的營收機會，並會隨之逐步累積。

With regard to the remainder of the P&L, the first quarter's total OpEx on both a GAAP and a non-GAAP basis is generally flat year-over-year. As expected, there are increases in sales team costs, which are substantially offset by decreases in G&A expenses. The sequential decrease in total OpEx expense from the fourth quarter of about $2 million is mostly in G&A costs and one-time expenses in the last quarter. The non-GAAP net loss per share of $0.07 in the first quarter is better by about $0.03 versus each of the previous three quarters.

關於損益表其餘部分，第一季在 GAAP 與非 GAAP 基礎下的總營運費用（OpEx）整體而言與去年同期大致持平。如預期，銷售團隊成本有所增加，但大部分被一般與行政（G&A）費用的下降所抵銷。相較第四季，總 OpEx 依序下降約 200 萬美元，主要來自 G&A 成本以及上季的一次性費用。第一季非 GAAP 每股淨損為 0.07 美元，較前三個季度各自改善約 0.03 美元。

With regard to the operating expenses, this slide is a graphic illustration of the operating expenses after eliminating noncash expenses for the periods reflected. Non-GAAP operating expenses of $11.7 million are basically in line with the average non-GAAP OpEx for the previous five quarters, meaning $11.7 million versus $12.0 million on average.

關於營運費用，這張投影片以圖示方式呈現在剔除所列期間的非現金費用後之營運費用。非 GAAP 營運費用為 1,170 萬美元，基本上與前五個季度的非 GAAP OpEx 平均值一致，也就是 1,170 萬美元對比平均約 1,200 萬美元。

Let me close with a few reimbursement highlights for the first quarter. In the first quarter, we sold almost 3,200 tests, reflecting about $8.7 million in pro forma revenue at our list price of $2,749. During the first quarter, we recognized revenue of about 14% of that, or $1.3 million.

最後我以第一季幾項給付（reimbursement）重點作結。第一季我們售出將近 3,200 項檢測，按我們 2,749 美元的定價計算，約相當於 870 萬美元的備考（pro forma）營收。第一季我們認列了其中約 14% 的營收，約 130 萬美元。

Recognized revenue included about 72% from insurance claims submitted in prior quarters, the longest dated item from over two years ago. Of the claims submitted in the first quarter, about 77% have been adjudicated and 23% are pending. Out of that 77% that have been adjudicated, about 31% resulted in an allowable amount by the insurance company with an average of $1,650 per test, which bumps up against the Medicare rate.

已認列的營收中，約 72% 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。第一季提交的理賠中，約 77% 已完成審理（adjudicated），23% 仍在待處理中。在已審理的 77% 當中，約 31% 被保險公司核定為可給付金額（allowable amount），每項檢測平均 1,650 美元，已接近 Medicare 的費率。

Of those denied, most fit into one of three buckets: a, deemed not medically necessary or investigational, that was about 38% or require prior authorization, that was about 16% or require additional medical records, that was about 10%. The balance are deemed to be noncovered.

在遭拒的案件中，多數可歸入三類之一：a，被認定為非醫療必要或屬研究性（investigational），約占 38%；或需要事前授權（prior authorization），約占 16%；或需要補充醫療紀錄，約占 10%。其餘則被認定為不在給付範圍內（noncovered）。

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

那麼，接線員，我們開放提問。

(Operator Instructions)

（接線員指示）

Mark, BTIG.

Mark，BTIG。

Good morning, Mark. Hey, good morning, guys. I figured I would start with a reimbursement question. Just curious if you -- would love just an update as far as what you might be hearing from MolDX. As someone who covers the industry, it was nice to see Medicare coverage decision come into the space yesterday. So we know that they're still open for business. But can you just give us a sense for what you're hearing, maybe any back and forth? Would love to hear any color on that topic. Thanks.

早安，Mark。嗨，早安，各位。我想先從給付問題開始。我只是好奇你們——很想聽聽你們更新一下，關於你們可能從 MolDX 那邊聽到什麼。以我這個追蹤產業的人來說，很高興看到昨天 Medicare 的給付涵蓋決策進入這個領域。所以我們知道他們仍在運作。但你們能否讓我們了解一下你們聽到的情況，可能有沒有任何往返溝通？很想聽聽這方面的更多資訊。謝謝。

Thanks, Mark. So we do continue to have ongoing dialogue with leadership. There is no sort of concrete or specific information with regard to where things stand, but we remain confident based on the results of the CAC meeting, and we've had follow-up conversations with regard to the CAC meeting that this remains a logistical issue with regards to delays more broadly with LCDs coming through as you sort of hinted.

謝謝，Mark。我們確實仍持續與其領導層保持對話。目前沒有任何具體或明確的資訊可以說明進度到哪裡，但基於 CAC 會議的結果，以及我們在 CAC 會議後的後續對話，我們仍然有信心：這主要是後勤／流程上的問題，涉及 LCD 整體出爐延遲的情況，正如你所暗示的。

I believe the LCD you're referring to is the Novitas LCD that published recently. But our conversations with them as well as with others who are knowledgeable and follow the space, there is a sense, I think, which is what you're hinting at that some of the backlog with LCDs is likely to start clearing in the near term.

我相信你指的 LCD 是近期發布的 Novitas LCD。不過，從我們與他們的對話，以及與其他熟悉並追蹤此領域人士的交流來看，確實有一種感覺——也就是你所暗示的——LCD 的積壓案件很可能在短期內開始逐步消化。

But just to be very, very clear about the fact that nothing in our conversations has raised any concerns with regard to the substantive nature of our expectations with regard to the likelihood of the draft coming out in a positive direction. And all of that confidence is anchored in the substance of the CAC meeting, which as we all know, is a public record of commentary that's very important in this process by physician experts across the country. So we continue to view this as a logistical delay and one that is -- that we still are highly confident will result in a positive outcome in the near future.

但我想非常、非常清楚地說明：在我們的對話中，沒有任何內容引發我們對於實質面（substantive nature）的擔憂，也不影響我們對草案朝正向方向發布之可能性的預期。這份信心完全建立在 CAC 會議的實質內容上；眾所周知，那是公開紀錄，且在此流程中非常重要，因為它包含全國各地醫師專家的評論。因此，我們仍將此視為一項後勤性的延遲，而且我們依然高度有信心，近期將會得到正向結果。

Okay. Perfect. It was nice to hear you guys talk about the VA activities off to a good start. Can you just give us a sense -- there are a lot of VA systems. So maybe can you give a little more color about what types of dialogues you're having, both either at the sort of the national level or at the local level? And then can you speak to EHR integration? I think that sometimes VAs have separate systems? Or maybe can you give us an update maybe they are starting to unify a bit in systems integration?

好的。非常好。很高興聽到你們提到 VA 的相關活動有個不錯的開始。你們能否讓我們了解一下——VA 系統很多，所以也許能多補充一些你們正在進行的對話類型，不論是在全國層級或地方層級？另外也想請你們談談 EHR 整合。我想 VA 有時候會有不同的系統？或者你們能否更新一下，他們是否開始在系統整合上更趨一致？

Yeah. Great. Great question. So let's go a little bit through a bit systematically about how the VA works, particularly as a result -- as it relates to molecular diagnostics like ours. So as you know, from our previous announcement that we are now on the federal supply schedule. We have the payment rate -- contracted payment rate under that schedule is the Medicare rate of $1,938. There are a couple of hundred VA centers across the country.

好的。很棒。這是個很好的問題。我們來更有系統地說明 VA 的運作方式，特別是——就分子診斷（molecular diagnostics）像我們這樣的產品而言。如你所知，根據我們先前的公告，我們現在已納入聯邦供應排程（federal supply schedule）。在該排程下的合約給付費率是 Medicare 費率 1,938 美元。全美有數百個 VA 中心。

And by being on the FSS, we have the opportunity for our team to engage with individual centers. And generally speaking, that's the starting point with regard to getting engaged with the VA is on a health center-by-health center basis. And so our team has a very, very deep pipeline, has had extensive outreach to the VA systems all across the country. I think I mentioned on our last call that our -- the internal process by which we are engaging with the VA includes our entire sales team, generating leads, generating connections with and engagements with clinical champions within their own region, but we've also centralized.

在納入 FSS 之後，我們的團隊就有機會與各個中心個別接洽。一般而言，與 VA 展開合作的起點，就是以醫療中心為單位逐一推進。因此，我們團隊建立了非常、非常深的管線，並已對全國各地的 VA 系統進行廣泛接觸。我想我在上次電話會議提到過，我們與 VA 接洽的內部流程涵蓋整個銷售團隊：開發線索、建立聯繫並與各自區域內的臨床意見領袖（clinical champions）互動，同時我們也進行了集中化。

We have two senior members of our team that are focused on nationally on sort of a strategic accounts manner with individual VAs. Those conversations, as we noted, are -- and engagements are going really well. The pipeline is robust. We have a number that are going through the process of working with the individual VA centers to ultimately, the way this works is you ultimately generate a PO that is for a number of tests.

我們有兩位資深成員，專注於全國層級、以策略性客戶（strategic accounts）的方式與各個 VA 進行合作。正如我們所提到的，這些對話與互動進展得非常順利。管線很強勁。我們有多個案子正在與各 VA 中心推進流程；最終，這個流程的運作方式是，你會取得一份針對一定檢測數量的採購單（PO）。

And then we work out the logistics with the clinical team in the center as a whole with regard to the cell collection part of it. So we've received our first PO, which is great and look forward to beginning testing at our first target, and there are actually many more along the way.

接著我們會與該中心整體的臨床團隊協調相關後勤，特別是細胞採集（cell collection）的部分。我們已收到第一張 PO，這非常好，也期待在我們的第一個目標中心開始檢測，而且後續其實還有很多正在路上。

The VAs obviously operate within the overall federal budget, and they all have their individual budgets. So when we work with the VAs, this is somewhat analogous to how we engage with other health systems on the -- other health systems, private or otherwise. But we do have to work in this case, within their budget. And so our opportunity between now and the end of the federal fiscal year is, in fact, to generate POs, which will be off budget. But in parallel, we're having conversations to be on the full budget for the next fiscal year as part of those parallel processes. So -- and that the federal fiscal year starts on October 1.

VA 當然是在整體聯邦預算框架下運作，而各中心也都有各自的預算。因此我們與 VA 合作時，在某種程度上類似於我們與其他醫療體系（不論民營或其他）合作的方式。但在這個案例中，我們必須在其預算限制內運作。因此，我們從現在到聯邦會計年度結束的機會，確實是在於取得 PO，這些將會是預算外（off budget）。但同時，我們也在平行進行對話，爭取在下一個會計年度納入完整預算（full budget），作為這些平行流程的一部分。聯邦會計年度於 10 月 1 日開始。

So really, overall, again, very positive, really good engagement. The engagements with the clinical team has been excellent -- with the clinical champions has been excellent. We've talked previously about the fact that there are some very unique aspects to the VA that enhance our ability to engage with the clinicians. The VA tends to have a population that is higher risk with regard to these conditions and also is often resource constrained with regard to the number of VGTs.

所以整體而言，再次強調，非常正面，互動非常良好。與臨床團隊——與臨床意見領袖的互動一直都很出色。我們先前也談過，VA 有一些非常獨特的特性，能提升我們與臨床醫師互動的能力。VA 的族群在這些疾病方面往往屬於較高風險，同時在 VGT 的數量上也常常受到資源限制。

So the value of the clinical utility and the economic value of EsoGuard as a triage test to the more expensive and more complicated invasive endoscopic procedure is a very attractive value proposition. Another aspect is that the VAs often operate rural centers that are actually quite remote from the main center. And they -- that's another obviously very -- a classic opportunity for a noninvasive test to prevent patients from having to travel to the main center.

因此，將 EsoGuard 作為分流檢測，用於導向更昂貴且更複雜的侵入性內視鏡檢查程序，其臨床效用與經濟價值非常具有吸引力。另一個面向是，VA 經常在鄉村地區設置中心，而這些中心實際上距離主要中心相當遙遠。而這——顯然也是一個非常——典型的非侵入性檢測機會，可避免病患必須前往主要中心。

One other aspect is that VAs, as you know, are often almost -- most VAs are engaged -- are partnered with academic medical centers. So many of the same physicians that we're in discussions with the health systems underlying academic medical centers are the same physicians who -- or partners of the same physicians who operate at the VA, and that's been a very useful aspect of these relationships and obviously, ultimately will help us within the health system as well.

另外一點是，如你所知，VA 往往幾乎——多數 VA 都會與學術醫學中心合作或結盟。因此，我們與學術醫學中心所屬醫療體系正在洽談的許多同一批醫師，也是在 VA 執業的同一批醫師——或是與其合作的夥伴；這一直是這些關係中非常有用的一環，並且顯然最終也會在醫療體系內對我們有所助益。

EHR integration with the VA is really not a major factor. I think you point out the fact that there's a lot of work, I believe, to integrate their systems. But in the individual health systems, it's much less of a factor than it is outside the VA system and our traditional commercial engagements, which we've discussed in our last call. Happy to talk a bit more about that.

與 VA 的 EHR 整合其實不是主要因素。我想你指出了確實有很多工作要做，據我了解，是要整合他們的系統。但在個別醫療體系中，這個因素的影響遠小於 VA 體系之外、以及我們傳統商業合作中的影響——我們在上次電話會議中也討論過。很樂意再多談一些。

Okay. That makes perfect sense. One last question for me. I believe you are coming up on your one-year anniversary of signing Highmark Blue Cross Blue Shield a year ago. And so in recent calls, you've had some really nice commentary about dialogue you're having with commercial payers. Can you just give us a sense for what that dialogue has been like the last number of weeks or so. I'd be curious if some of these commercial payers might be perhaps waiting for CMS to move first? Or do you think that you could sign some even without CMS?

好的。這完全說得通。我最後一個問題。我相信你們即將迎來一年前與 Highmark Blue Cross Blue Shield 簽約的周年。最近幾次電話會議中，你們對於與商業保險支付方的對話有一些很不錯的評論。你能否讓我們了解一下過去幾週左右這些對話的情況？我很好奇，是否有些商業支付方可能在等 CMS 先行動？或者你認為即使沒有 CMS，你們也能簽下一些？

Yeah. So that actually has been our stance. And frankly, our position and our expectation was that really for us to get any meaningful traction within -- on the commercial front that we would have to wait for Medicare. And there certainly are a subset and maybe even the majority of payers where that is -- we would need that as a catalyst or accelerant to advance our conversations and secure coverage. However, as we sort of introduced previously, that hasn't been the case for others.

是的。其實那一直是我們的立場。坦白說，我們的定位與預期是：要在商業端取得任何有意義的進展，我們確實必須等待 Medicare。當然，確實有一部分、甚至可能是大多數的支付方，需要以此作為催化劑或加速器，來推進我們的對話並取得給付涵蓋。不過，正如我們先前提到的，對於其他一些支付方，情況並非如此。

So one very interesting and potentially productive pathway that we are pursuing is engaging with certain payers who have published on their own EGD endoscopy policies that explicitly reference EsoGuard as an appropriate triage test to -- that drives the indication for endoscopy. And -- so that activity, which we highlighted in the last couple of calls is very active. There's a whole process that you go through.

因此，我們正在推進的一條非常有趣且可能富有成效的路徑，是與某些支付方合作；這些支付方在其自身已發布的 EGD 內視鏡政策中，明確提及 EsoGuard 可作為適當的分流檢測——用以驅動內視鏡檢查的適應症。並且——我們在過去幾次電話會議中強調的那項工作非常活躍。這其中有一整套流程需要走。

This is separate from the laboratory benefit manager process, which I'll touch on in a second. But that activity involves credentialing as well as engaging in contracting. And those are -- that's a process that we are actively pursuing with the payers that have published policies -- coverage policies that include EsoGuard as a triage test for endoscopy.

這與實驗室福利管理者（LBM）的流程是分開的，我稍後會提到。但這項工作包含資格認證（credentialing）以及合約洽談（contracting）。而這些——就是我們正在積極推進的流程，針對那些已發布將 EsoGuard 納入、作為內視鏡分流檢測之給付政策的支付方。

With regard to the laboratory benefit manager side of things, again, as we've talked about before, we continue to have positive engagements with laboratory benefit managers as we previewed last time, and we'll reiterate today, we do -- we have secured our first coverage policy with a laboratory benefit manager.

至於實驗室福利管理者這一端，如同我們之前談過的，我們持續與 LBM 進行正向互動；正如上次我們預告、今天也再次重申，我們——已經取得我們第一份由 LBM 發布的給付涵蓋政策。

It's not public yet, but it will be public in the next couple of weeks. And we expect after that's public that plans under that LBM will also publish their own positive coverage policies. And again, I think I mentioned this last time, we've had very good conversations with one of the largest LBMs on a pathway forward for coverage.

目前尚未公開，但會在接下來幾週內公開。我們預期在公開之後，該 LBM 旗下的健康保險計畫也會發布各自的正向給付涵蓋政策。而且，我想我上次也提到過，我們已與其中一家最大的 LBM 就給付涵蓋的推進路徑進行了非常良好的對話。

Great. Thanks, guys, for the time.

很好。謝謝各位撥冗。

Thanks, Mark.

謝謝你，Mark。

Kyle, Canaccord.

Kyle，Canaccord。

Morning, Kyle.

早安，Kyle。

Hi, guys. Morning. So I wanted to start where we typically start off with and ask about the percentage of claims that are represented by the Medicare segment. So it's been like -- we think like the increasing portion of the test that you guys report, still kind of probably below 20% of the total claims, but how is that -- where does that stand now?

嗨，各位。早安。我想先從我們通常會先問的問題開始：由 Medicare 區塊所代表的理賠占比是多少？看起來——我們認為你們所回報的檢測量中，Medicare 的占比在增加，但可能仍低於總理賠的 20%；不過現在——目前的情況如何？

And when you think about some of your efforts to either increase the sales team in favor of more like Medicare-focused reps or maybe train them or incentivize them a little more to kind of increase that kind of area -- that segment of the market a bit more? How is that progress as well in light of the -- hopefully, like increased percentage like the mix as well?

另外，當你們考量一些努力方向，例如擴增銷售團隊、偏向更多以 Medicare 為主的業務代表，或是對他們進行訓練、或提高一些激勵，以便把那個領域——也就是那個市場區隔——再拉高一些時；在希望占比提升、組合改善的背景下，這方面的進展如何？

I'll let Dennis touch on the numbers, and we can fill in some of the operational side as well.

我先讓 Dennis 談談數字，我們也可以補充一些營運面的內容。

So Kyle, the -- I'll call it the government group, which is predominantly Medicare and Medicare Advantage was 13% in the first quarter. As you recall, in the fourth quarter, it was around 15%. That 2% delta is around 60-some tests.

Kyle，所謂的——我稱之為政府組別，主要是 Medicare 與 Medicare Advantage，在第一季占 13%。如你所記得，第四季大約是 15%。這 2% 的差距大約是 60 多個檢測。

But the compensation plans for the sales team, and Lishan will expand upon this, is focused on predominantly the revenue-generating components of the target population. That is contracted revenue as well as Medicare and VA. That's where their focus is in generating test volume. So we're in that transition phase.

不過，銷售團隊的薪酬方案——Lishan 會再擴充說明——主要聚焦在目標族群中能帶來收入的部分，也就是合約收入，以及 Medicare 與 VA。這是他們在帶動檢測量方面的重點。因此我們正處於那個轉換期。

Yeah. And as it relates to allocating resources, we've stated on several occasions our commitment to not add resources and not meaningfully increase our OpEx. And so what our team is really doing is a balancing act between a target of maintaining our test volume and slightly exceeding it, which is most efficiently done through these increasingly contracted health care events, while positioning ourselves so that once we get Medicare that we can aggressively drive up that percentage.

是的。至於資源配置方面，我們已多次表明，我們承諾不增加資源，也不會實質性提高我們的營運費用（OpEx）。因此，我們團隊正在做的是一種平衡：一方面以維持、並略微超過我們的檢測量為目標——這最有效率的方式是透過這些日益增加的已簽約醫療活動；同時也讓我們做好定位，以便一旦取得 Medicare，我們就能積極把那個占比拉高。

So on a quarter-to-quarter basis until we get Medicare, we're not expecting that number to rise dramatically because we are -- the team is sort of in parallel focused with the same level of resources at maintaining our overall test volume.

因此，在取得 Medicare 之前，以季度對季度來看，我們不預期那個數字會大幅上升，因為——團隊在相同資源水準下，仍是並行地把重點放在維持整體檢測量。

Okay. That's interesting. That's good color, guys. And then on the -- Dennis, you provided a bunch of numbers and you do this every quarter, I think, around like the percentage of claims you're recognizing revenue on, then the -- like the percentage that's adjudicated, like what's actually paid on there, what's the ASP there. So how have some of those like metrics kind of changed over time. I don't have all that in front of me.

好的。這很有意思。這些說明很有幫助。接著——Dennis，你提供了很多數字，而且我想你每季都會這麼做，例如你們認列收入的理賠占比、然後——例如已裁定（adjudicated）的占比、實際支付的占比、以及那裡的 ASP。那麼這些指標隨時間推移有什麼變化？我手邊沒有全部資料。

I'm just curious if -- like to the earlier point, if -- obviously, like non-Medicare payers are getting more comfortable with this product? Or are they almost like waiting and maybe payment or kind of ASP and that is actually reducing because just the waiting is kind of taking longer than maybe was like communicated maybe so just if that makes sense, if you could give a snapshot on how that's progressed.

我只是好奇——呼應前面那點——顯然非 Medicare 的支付方是否對這個產品越來越有信心？還是他們幾乎是在等待，導致付款或 ASP 等實際上在下降，因為等待時間比先前可能溝通的更久？如果這樣問有道理的話，能否給個快照，說明一下進展情況。

Yes, it's still pretty volatile, and it's difficult to make sense on those that don't have a specific program or don't have consistency in payment. And the first quarter certainly clouds or increases that volatility because you have an increased amount of deductibles and co-pays where patient burden in the first quarter is heavier than it would be in the balance of the year, which influences what we get paid from some of those insurers.

是的，仍然相當波動，而且對於那些沒有特定方案或付款一致性的支付方，很難看出明確結論。第一季確實會讓波動更明顯或加劇，因為自付額與共付額增加，病患在第一季的自付負擔比年內其他時間更重，這會影響我們從部分保險公司收到的付款。

So even where we see some pluses and minuses in the first quarter versus, say, the third or fourth quarter, we still have to rely upon cash collection for the revenue recognition. And there is really not a sufficient pattern to give you an adequate answer to your question yet that those patterns are still developing.

因此，即使我們看到第一季相較於例如第三或第四季有一些正負變化，我們在收入認列上仍必須依賴現金收款。而目前還沒有足夠的模式，能讓我對你的問題給出充分的答案；這些模式仍在形成中。

Okay. Fair enough. And then -- and finally, we see where R&D is coming in each quarter. It's been pretty consistent, $1 million to $2 million in expenses. But are you guys either still doing or thinking about generating clinical evidence either in a worst-case scenario with MolDX, which doesn't sound like it's happening with just obviously worst case or if you want to go for FDA or things like or just kind of like enhance the acceptance. I'm just curious if that line item could maybe expand over time.

好的。合理。然後——最後，我們看到每一季研發（R&D）的支出情況。一直相當一致，費用大約在100萬到200萬美元之間。但你們是否仍在進行、或正在考慮產生臨床證據——例如在最壞情境下因應 MolDX（聽起來目前不太可能發生，但只是明顯的最壞情境），或是如果你們想走 FDA 路線之類的，或只是為了提升接受度。我只是好奇，這個費用項目是否可能隨時間而擴大。

Yes. I'm glad you highlighted. The answer is a definite yes. But I'm glad you at least highlighted and I'd like to emphasize the fact that our commitment to ongoing data generation and ongoing clinical evidence is not connected to the fact that we believe that we have sufficient evidence to secure the LCD.

是的。我很高興你提出這點。答案是明確的「是」。但我也很高興你至少點出來，我想強調的是：我們對持續產生數據與持續累積臨床證據的承諾，並不取決於我們是否認為已有足夠證據來取得 LCD。

But we are a data-driven company. We firmly believe in expanding our clinical evidence on an ongoing basis. And there is a lot of activity. It doesn't get a lot of attention because everyone is focused on -- we're all very much focused on the reimbursement side.

但我們是一家以數據驅動的公司。我們堅信要持續擴充我們的臨床證據。而且目前有很多活動。只是因為大家都把焦點放在——我們也都非常聚焦在給付（reimbursement）面向——所以這些並沒有受到太多關注。

But there are ongoing clinical studies. There are ongoing institutional clinical studies. There's an active NIH study going on right now. We have a registry. We've been collecting real-world evidence. And it would be a long conversation, but there is an interesting dynamic right now, now that we're well out from the courts vacating the FDA LDT rule as to how -- what the advantages of engaging with the FDA may be for single laboratory tests.

但確實有持續進行的臨床研究，也有持續的機構型臨床研究。現在正有一項 NIH 的研究在進行。我們也有登錄研究（registry）。我們一直在收集真實世界證據（real-world evidence）。如果要細談會很長，但目前有一個有趣的動態：在法院撤銷 FDA 的 LDT 規則之後，現在我們已經走出那段時間，關於——對於單一實驗室檢測（single laboratory tests）而言，與 FDA 互動可能有哪些優勢。

And we're certainly aware of those, and we're crafting our longer-term strategies in relation to that -- the fact that, that landscape is settling a little bit. And certainly, our longer-term goals with regard to generating clinical evidence is fundamentally informed by that.

我們當然了解這些，也正在據此擬定更長期的策略——因為那個環境正在逐步穩定下來。而且，我們在產生臨床證據方面的長期目標，基本上也深受這些因素所影響。

Great. And if I could just like add on to that just briefly. Years ago, I think your guys' intention was to scale this test, the collection device and the test internationally globally. They're both CE marked in Europe, obviously.

很好。如果我可以再簡短補充一下。幾年前，我記得你們的意圖是把這個檢測、採集裝置以及檢測本身在國際上、全球化地擴大規模。很明顯兩者在歐洲都已取得 CE 認證。

So would you -- I mean, how much more extra clinical evidence would be needed for some kind of an international expansion or kind of decentralized model with a partner, distributed model with a partner? Is that part of the kind of formula as you look maybe over the medium to long term?

所以你們會——我的意思是，若要做某種國際擴張，或與合作夥伴採取去中心化模式、分銷式模式，還需要多少額外的臨床證據？這是否是你們在中長期評估時的其中一部分公式？

So just maybe we could separate the clinical evidence question from the international market question. So clinical evidence is not a limiting factor for us to potentially expand internationally. We looked from day 1 at opportunities internationally, both in Europe. As you noted, we went ahead and got CE Mark right off the bat from the earliest days.

所以也許我們可以把「臨床證據」的問題與「國際市場」的問題分開來看。就臨床證據而言，它並不是我們潛在進行國際擴張的限制因素。我們從第一天起就看國際機會，包括歐洲。如你所說，我們在最早期就立即取得 CE Mark。

And the challenge is the US is obviously the largest market opportunity where we remain a small company. We have limited resources. And so we certainly are -- certainly would expect to focus our resources in the near term. Europe is a very difficult market for screening test because of the overall economics of their socialized health system.

而挑戰在於，美國顯然是最大的市場機會，但我們仍是一家小公司，資源有限。因此我們當然——也確實預期在短期內把資源聚焦在美國。歐洲對於篩檢（screening）檢測而言是非常困難的市場，因為其社會化醫療體系的整體經濟性。

And when we looked at this in the past, it just simply has not made sense. And I believe even many of the larger companies, their traction in Europe is molecular diagnostic companies is more limited. That said, we do, on a regular basis, get inbound inquiries from -- I think as you were suggesting, from commercial entities in various OUS countries for the opportunity to partner.

而我們過去評估時，結果就是根本不划算。我認為即便是許多較大的公司，他們在歐洲的分子診斷（molecular diagnostic）業務推進也更為有限。話雖如此，我們確實會定期收到——正如你所暗示的——來自美國以外（OUS）各國的商業實體主動詢問合作機會。

We've had from Canada, South America, the UK and we engage in those conversations, and we've explored every -- each of them as whether that's something that with limited resources on our part, we could engage in activity in those markets with the help of a local partner. None of those have really come to fruition. None of them have really -- have made sense from an overall business strategy point of view, but it's certainly something we're open to.

我們曾收到來自加拿大、南美、英國的詢問，我們也都有進行對話，並逐一評估：在我們資源有限的情況下，是否能在當地合作夥伴的協助下在那些市場展開活動。但這些都沒有真正落地。從整體商業策略角度看，沒有一個真正——有意義；不過這當然是我們願意保持開放的方向。

And again, those activities are really related to the local sort of economic dynamics in these regions and countries. It's not really -- it doesn't really inform our clinical evidence plan. That's really related to our US business.

而且再說一次，這些活動主要與各地區、各國的在地經濟動態有關。它並不——不太會影響我們的臨床證據規劃。那部分主要是與我們的美國業務相關。

That's helpful. Thanks, guys. Appreciate it.

這很有幫助。謝謝各位。感謝。

Thanks, Kyle.

謝謝你，Kyle。

Mike, Needham.

Mike，Needham。

Hey, thanks for taking my questions. I guess just the DDW presence that you guys had, can you maybe comment on kind of interest level you're seeing from physicians, any kind of feedback, et cetera?

嗨，謝謝回答我的問題。我想問一下你們在 DDW 的出席情況，你們能否評論一下你們從醫師那邊看到的興趣程度、任何回饋等等？

Yeah. Thanks for -- I'm just chuckling a little bit here, Mike. Thanks for bringing that up because that was the portion of our -- of the prerecord that got garbled. So I'm happy to have the opportunity to fill that. DDW went great. So for those on the call who are not aware of this, DDW is the largest gastroenterology meeting in the country, one of the two or three major ones here in the US.

是的。謝謝——我在這裡稍微笑了一下，Mike。謝謝你提到這個，因為那是我們——預錄內容中被弄得有點失真的部分。所以我很高興有機會補充。DDW 進行得非常順利。對於電話會議上不熟悉的人，DDW 是全國最大的胃腸科會議，也是美國這裡兩三個主要會議之一。

And we had a very strong presence there, both from our commercial team and our clinical team, lots of engagement with clinicians. Just overall, it was our best -- frankly, our best conference ever, just very -- there's a lot of just generalized increased attention, increased buzz around esophageal precancer screening and Barrett's esophagus in particular, on multiple fronts, and we very much benefited from that in our engagements, and they were very positive. We had a significant presence on the academic side. There were multiple abstracts that -- related to EsoGuard that were very well received.

我們在那裡有非常強的曝光，商務團隊與臨床團隊都到場，與臨床醫師有大量互動。整體而言，那是我們最——坦白說，是我們有史以來最好的會議；在多個面向上，大家對食道癌前病變篩檢、尤其是巴瑞特食道（Barrett's esophagus）的關注度與討論熱度都明顯提升，而我們在互動中也非常受益，反應非常正面。我們在學術端也有顯著存在感。有多篇——與 EsoGuard 相關的摘要（abstracts）獲得非常好的回響。

One of the highlights of the meeting in addition to all of that was that the American Gastroenterologic Association presented a preview of an upcoming update draft of their updated guidelines -- clinical practice guidelines for Barrett's esophagus. And we're very excited about that.

除了上述之外，會議的一個亮點是美國胃腸病學協會（American Gastroenterologic Association）預覽了他們即將更新的指南草案——針對巴瑞特食道的臨床實務指南（clinical practice guidelines）。我們對此非常興奮。

They -- for the first time, at least in this preview, they highlight individual non-endoscopic testing -- tests, including EsoGuard and EsoCheck by name, and they evaluate the clinical evidence for accuracy, the certainty of the evidence. And EsoGuard and EsoCheck came out were presented as having high certainty of evidence, which -- and it was the only one, the rest of the potential future modalities were rated as well.

他們——至少在這次預覽中——首次點名強調個別的非內視鏡檢測——包括 EsoGuard 與 EsoCheck，並評估其臨床證據的準確性與證據確定性（certainty of the evidence）。EsoGuard 與 EsoCheck 的呈現結果是具有高確定性的證據——而且它是唯一一個；其他潛在的未來檢測方式也都有被評等。

Now this is a preview with a draft, but there was a lot of excitement and a lot of buzz around this. Obviously, guidelines are a very important driver, an important part of our engagement, particularly with commercial payers having this finalized in this form will be a real.

當然，這只是草案的預覽，但市場上對此有很多興奮與討論。很明顯，指南是非常重要的驅動因素，也是我們互動中的重要一環，特別是面向商業保險支付方（commercial payers）。若最終能以這種形式定稿，將會是一個真正的。

Okay. Great. And then just a few financial questions. So I guess, Dennis, the share count, what should we be modeling? I think you said post offering, it's 203 million, but there's 22 million in abeyance. I'm not sure if we should be including that in our share count or not for now.

好的。很棒。接著幾個財務問題。我想問一下，Dennis，股數方面我們應該怎麼建模？我記得你說增發後是2.03億股，但有2,200萬股暫緩發行（in abeyance）。我不確定我們現在是否應把那部分納入股數。

Yes. The 203 million is the number you should model your EPS on. The remaining 22 million shares will be issued once the holders 4.99% limitation is lowered either by distributing it to their members or if the share count goes up. So I think 203 million for the time being is probably the right number. But in the future, that additional 22 million, that they're owed to those investors will be issued. These are long-term shareholders. So it may be a while before they get issued. But nonetheless, they're out there, but 203 million is probably the right number to use for your EPS modeling.

是的。2.03億股是你用來建模每股盈餘（EPS）的數字。剩下的2,200萬股會在持有人 4.99% 持股上限被降低後發行，方式可能是分配給其成員，或是總股本增加。因此我認為就目前而言，2.03億股大概是正確的數字。但未來，那額外的2,200萬股——他們應付給那些投資人的——會發行。這些是長期股東，所以可能要一段時間才會發行。不過無論如何，那些股份是存在的；但你用2.03億股來做 EPS 建模應該是對的。

All right. And then the quarterly cash burn rate, given that you did raise some additional capital and you're getting closer to the Medicare coverage, is there any potential that, that would go up? Or are you expecting to kind of hold it around recent levels?

了解。那麼季度現金消耗率（cash burn rate）方面，鑑於你們確實又募到一些資金，而且也更接近 Medicare 給付覆蓋，是否有可能會上升？還是你們預期會大致維持在近期水準附近？

I think the burn rate at where it is right now is probably the level it will stay. Yes, we will be making additional investments. We do think some of that cost, if not all of that cost will be offset by revenue opportunity, either collections or increased volume as we move forward with increased reimbursement landscape.

我認為目前的燒錢速度大概就是它將維持的水準。是的，我們會進行額外投資。我們確實認為其中部分成本（如果不是全部成本）將可由營收機會所抵銷，無論是透過收款（collections）或是隨著我們在更有利的給付／報銷環境下推進而帶來的量能提升。

Okay. Great. Thank you.

好的。很好。謝謝你。

Jeremy, Maxim.

Jeremy，Maxim。

Good morning. Thank you for taking my question. Just related to the VA, I think I inferred -- correct me if I'm wrong, that in the first quarter, there was no contribution to both volume or revenue from the VA opportunity from that contract?

早安。謝謝讓我提問。就 VA 而言，我的理解是——如果我錯了請糾正我——在第一季，該合約帶來的 VA 機會對量能與營收都沒有貢獻，對嗎？

Yeah. The first quarter, as you remember the announcement was in late January, and the first quarter was focused on pipeline metrics and building a pipeline, converting engagement into purchase orders. So you'll see more of that as the year unfolds, but that's correct in the first quarter.

是的。第一季，如你所記得，我們是在一月底才宣布，而第一季主要聚焦在管線指標與建立管線，把互動（engagement）轉化為採購訂單（PO）。所以你會在今年接下來的時間看到更多進展，但第一季確實是這樣。

Okay. Understood. And then just also, is that -- is the reimbursement from the VA contract, that's completely separate from Medicare, right? You'll get whatever the 1,900 rate for the test, you'll get reimbursed through the VA system regardless of when you get the CMS reimbursement. So you can go full steam ahead on that opportunity.

好的。了解。另外，VA 合約的報銷是——它跟 Medicare 是完全分開的，對吧？你們會以每次檢測 1,900 的費率，透過 VA 系統獲得報銷，不管 CMS 的報銷何時到位。因此你們可以全力推進這個機會。

That's correct. Yes, it's direct payment through the VA. Obviously, we're appreciative that we were able to secure the same rate as Medicare, but the process is entirely separate from Medicare, and it's just directly through the VA through POs that get invoiced and paid.

沒錯。是的，這是透過 VA 的直接付款。我們當然很感謝能夠取得與 Medicare 相同的費率，但流程與 Medicare 完全分開，就是透過 VA 的採購訂單（PO）開立發票並收款。

Right. No, that's great. And maybe also, I don't know if you have this number, how many, let's say, we'll call it covered lives you have currently based post the VA? I think you mentioned last call that was roughly 9 million lives and then maybe the commercial payers that you have also under contract now, how many covered lives and when -- hopefully, when you get the Medicare, what would that increase to?

對，這很棒。再問一下，也許你們有這個數字：在納入 VA 之後，你們目前大概有多少「受保人數」（covered lives）？我記得你們上次電話會議提到大約是 900 萬人；那麼目前已簽約的商業保險付款方（commercial payers）又涵蓋多少受保人數？以及——希望——當你們拿到 Medicare 之後，這個數字會增加到多少？

Well, I mean, it's a bit of a multifaceted question there, right? The VA, as you mentioned, is 9 million patients, and we'll be able to target that we're able -- that's available to us right now. Medicare, the epidemiology of the conditions that lead to a recommendation for testing, the target population is at least approximately 50% Medicare. And as once we have Medicare coverage, there's no reason we can't, as others have done, expand beyond that number. And Medicare, I believe, represents 60 million to 80 million people overall. So that's that.

嗯，這其實是個多面向的問題，對吧？如你所說，VA 是 900 萬名病患，而我們現在就能鎖定並觸及這個族群。至於 Medicare，就會導致建議進行檢測的那些疾病之流行病學來看，目標族群至少約有 50% 是 Medicare。一旦我們取得 Medicare 覆蓋，沒有理由不能像其他公司一樣把規模擴大到超過這個比例。另外，Medicare 整體我相信涵蓋約 6,000 萬到 8,000 萬人。所以大概是這樣。

On the commercial side, we're not -- we haven't yet reached the level. We're still in the early stages with contracting and -- with coverage and contracting. So we have not reported on covered lives. Once this first LBM laboratory benefit manager coverage policy is publicized, and we hear from the payers that operate that work under that outsource their technical assessments to that LBM we'll be able to start discussing covered lives. But it's a little bit premature to do that on the commercial side.

在商業端，我們還——尚未達到那個程度。我們在給付覆蓋與簽約方面仍處於早期階段，因此尚未對外報告受保人數。一旦第一個 LBM（實驗室福利管理者，laboratory benefit manager）的實驗室福利管理覆蓋政策公開，並且我們收到那些將技術評估外包給該 LBM 的付款方回饋後，我們就能開始討論受保人數。但就商業端而言，現在談還有點太早。

Okay. Understood. And then just last question. How would you -- how should we look at your sales force productivity currently versus, let's say, what it was a year ago in the sales cycle, especially considering now you said -- I think you said your entire sales team is also engaging with the VA. So they have -- there's new, I guess, job descriptions they have, they're new. So how should we look at that?

好的。了解。最後一個問題：你們目前的銷售團隊生產力，和例如一年前相比，以及銷售週期方面，我們應該怎麼看？尤其考量到你們說——我想你們說你們整個銷售團隊也都在與 VA 接洽。所以他們——我想他們的工作內容有新的部分，是新的。那我們應該怎麼看待？

Yeah. I think productivity is solid. It's gone up over the years. We have an increasingly tenured and increasingly experienced staff. But what we're asking them to do is sort of juggle multiple things at the same time, right, to maintain their test volume, to drive, to find opportunities within the VA system that they can hand over to our national director on that.

是的。我認為生產力很穩健，這些年來也有所提升。我們的團隊任職年資更長、經驗也更豐富。但我們要求他們同時要兼顧多件事，對吧：維持檢測量能、推動業務，並在 VA 系統內找出機會，然後交由我們負責該部分的全國總監來接手。

And so -- yes, productivity as a whole is great. And I think as we mentioned, we are -- we have positioned ourselves. We have been positioning ourselves with regard to the composition of our team to have some more senior level folks so that when the time comes to expand the team that we'll be able to do so and sort of the most efficient way to maintain that productivity as we expand our team.

所以——是的，整體生產力非常好。而且如我們提到的，我們——我們在團隊組成上已經做了布局。我們一直在配置一些更資深層級的人員，這樣當需要擴編團隊時，我們就能以最有效率的方式擴張，同時維持生產力。

Okay, great. Thank you for taking my questions. Enjoy the rest of your day.

好的，很好。謝謝回答我的問題。祝你今天剩下的時間愉快。

Ed Woo, Ascendiant Capital.

Ed Woo，Ascendiant Capital。

Yeah, congratulations. My question is on the Medicare reimbursement rate. Is there any opportunity to increase it over time?

是的，恭喜。我的問題是關於 Medicare 的報銷費率：未來是否有機會隨時間提高？

We have no plans to do so. I mean there -- the whole Medicare fee schedule process is a complex one, but we have no particular plans to pursue that. We're quite happy with that rate, and we feel we can build a very robust business under this.

我們沒有這樣的計畫。我的意思是——整個 Medicare 費率表（fee schedule）的流程很複雜，但我們沒有特別打算去推動這件事。我們對這個費率很滿意，也認為在這個費率之下可以建立非常穩健的業務。

Great. Well, that's all the questions I have. I wish you guys good luck. Thank you.

很好。那我就沒有其他問題了。祝你們好運。謝謝。

Thanks, Ed.

謝謝你，Ed。

There are no further questions at this time. I'll turn the call back over to Dr. Lishan Aklog.

目前沒有其他提問。我將把電話會議交回給 Lishan Aklog 醫師。

Great. Thanks, operator, and thank you all for taking the time and for your attention this morning. Again, apologies for the technical glitch that led to me being cut off. I appreciate the opportunity. Obviously, great questions as always, from our analysts and appreciate the opportunity to fill in some of those gaps. I hope you all found this dialogue informative.

很好。謝謝接線員，也謝謝各位今天早上撥冗並專注聆聽。再次為導致我被切斷的技術問題致歉。我很感謝這個機會。顯然，一如往常，我們分析師提出了很棒的問題，也感謝有機會補足其中一些空白。我希望各位覺得這次對話很有幫助。

So again, just obviously, we're acknowledging and sharing some of the frustrations with regard to the logistics around the LCD process, but just continue to reiterate our confidence has not wavered that this is a near-term positive outcome. Again, as we've said repeatedly, as we await to draft LCD, we're not resting on our laurels. We are very encouraged by our efforts on multiple fronts, our engagements with the VA, our securing of our first positive coverage policy from a laboratory benefit manager and great opportunities on the commercial payer side as well as something we didn't spend as much time on today, but is working on -- is progressing very nicely, which is our engaging with a series of major health systems.

所以再次強調，顯然我們也理解並分享大家對 LCD 流程在後勤／作業面（logistics）上的一些挫折感，但我們仍一再重申，我們的信心並未動搖：這將在短期內帶來正面的結果。同樣地，如我們反覆提到的，在等待 LCD 草案期間，我們並沒有停下腳步。我們對多方面的努力感到非常鼓舞：我們與 VA 的合作、我們取得第一個來自實驗室福利管理者的正向覆蓋政策，以及商業付款方端的良好機會；另外還有一項我們今天沒有花太多時間談，但正在推進且進展非常順利的工作，就是我們與一系列大型醫療體系的接洽。

And obviously, we came out of the DDW meeting very energized and feeling very positive about the prospects of an updated guideline that enhances our position within this field. So thanks again. As always, we encourage you to keep abreast of our progress. Please follow up -- follow our news releases, these update calls and on our website and social media and feel free to reach out to us if you have any questions. So thanks again, everybody, and have a great day.

而且很明顯地，我們從 DDW 會議回來後感到非常振奮，並對更新版指引有望提升我們在此領域的定位感到非常正面。所以再次感謝。也一如往常，我們鼓勵各位持續關注我們的進展。請持續留意——追蹤我們的新聞稿、這些更新電話會議，以及我們的網站與社群媒體；若有任何問題也歡迎與我們聯繫。再次謝謝大家，祝各位有美好的一天。

Ladies and gentlemen, this concludes 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。