Grail Inc (GRAL) 2026 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the GRAIL second quarter 2026 earnings call. (Operator Instructions) Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.

各位女士、先生，大家好，歡迎參加 GRAIL 2026 年第二季財報電話會議。(接線員指示) 請注意，本次電話會議將被錄音。GRAIL 投資人關係部，請開始。

Thank you, and thank you all for joining us today. On the call are Joshua Ofman, our Chief Executive Officer; Aaron Freidin, Chief Financial Officer; -- sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs; and Andrew Partridge, Chief Growth Officer. I'll remind you that we'll be making forward-looking statements based on current expectations. It's our intent that all statements other than statements of historical fact, including statements regarding our anticipated financial results and commercial activity will be covered by the safe harbor provisions for forward-looking statements under federal securities laws.

謝謝，並感謝各位今天加入我們的會議。出席本次電話會議的有：我們的執行長 Joshua Ofman；財務長 Aaron Freidin；— Harpal Kumar 爵士，首席科學長兼全球臨床與醫療事務總裁；以及首席成長長 Andrew Partridge。我提醒各位，我們將根據目前的預期發表前瞻性陳述。我們的意圖是，除歷史事實陳述之外的所有陳述（包括關於我們預期的財務結果與商業活動之陳述）均受聯邦證券法下前瞻性陳述安全港條款之保障。

Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and GRAIL assumes no obligation to update these statements.

前瞻性陳述受到風險與不確定性影響。實際事件或結果可能與所預測或討論者有重大差異。所有前瞻性陳述均以目前可得資訊為基礎，GRAIL 不承擔更新此等陳述之任何義務。

To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL files with the Securities and Exchange Commission, including the Risk Factors section in GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q we plan to file for the second quarter of 2026. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which exclude certain specified items.

為更了解可能導致實際結果不同的風險與不確定性，我們請各位參閱 GRAIL 向美國證券交易委員會提交的文件，包括 GRAIL 最近一期 Form 10-K 年報中的「風險因素」章節，以及我們計畫就 2026 年第二季提交的 Form 10-Q 季報。本次電話會議亦將討論 GAAP 結果及若干非 GAAP 財務衡量指標，包括調整後毛利與調整後 EBITDA，該等指標排除若干特定項目。

Our non-GAAP financial measures are intended to supplement your understanding of GRAIL's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is available on our website.

我們的非 GAAP 財務衡量指標旨在補充各位對 GRAIL 財務狀況的理解。非 GAAP 指標與最直接可比 GAAP 財務指標之調節表，已載於我們今日發布的新聞稿中，並可於我們網站取得。

With that, we turn to Josh.

接下來交給 Josh。

Thank you. Good afternoon, everybody, and thanks for joining us to review the results of the second quarter 2026 and discuss recent business updates. GRAIL continues to execute across our clinical and commercial priorities. We launched the Galleri test in 2021 after our approximate 6,000 participant interventional PATHFINDER study, which was conducted under an FDA-approved investigational device exemption and read out and demonstrated strong performance and safety in a screening population.

謝謝。各位下午好，感謝各位加入我們，一同回顧 2026 年第二季的業績並討論近期的業務更新。GRAIL 持續在臨床與商業優先事項上推進執行。我們在 2021 年推出 Galleri 檢測，該推出係基於約 6,000 名受試者的介入性 PATHFINDER 研究；該研究在 FDA 核准的研究用醫療器材豁免（IDE）下進行，並已公布結果，於篩檢族群中展現強勁的效能與安全性。

For several years, PATHFINDER was the only interventional study that clearly demonstrated the benefits and evaluated the potential harms of deploying an MCED test in the intended use population. Since then, we've read out two additional large studies, our 35,000 participant PATHFINDER 2 study in North America and the groundbreaking 140,000 participant NHS-Galleri trial in England, which included three annual tests.

多年來，PATHFINDER 一直是唯一一項介入性研究，能清楚展示在預期使用族群中部署 MCED 檢測的效益，並評估其潛在危害。此後，我們又公布了兩項額外的大型研究：在北美進行、受試者 35,000 人的 PATHFINDER 2 研究，以及在英格蘭進行、具開創性的 140,000 名受試者 NHS-Galleri 試驗，其中包含每年一次、連續三年的檢測。

We recently presented detailed performance, safety and clinical utility results from these studies at the 2026 American Society of Clinical Oncology Annual Meeting, and they are currently under review for publication, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies.

我們近期在 2026 年美國臨床腫瘤學會（ASCO）年會上，發表了上述研究的詳細效能、安全性與臨床效用結果；目前正接受發表審查，進一步確立 Galleri 為唯一一項具有介入性研究所提供之廣泛臨床驗證的 MCED。

These data in the asymptomatic screening population are critical for physicians and patients to understand test performance as case-controlled studies can fail to replicate performance when tests are rolled out in an intended use population.

這些來自無症狀篩檢族群的數據，對醫師與病患理解檢測效能至關重要，因為病例對照研究在檢測於預期使用族群中推廣時，可能無法重現其效能表現。

We're extremely proud of the unparalleled performance demonstrated in these studies in the screening population, and we're focused on driving to FDA approval and subsequent Medicare and commercial reimbursement. Galleri test performance is highly differentiated with a false positive rate of less than 0.5%, resulting in at least 3 times to 6 times fewer false positives than other MCED tests in development.

我們對這些研究在篩檢族群中展現的無與倫比的效能深感自豪，並專注於推進 FDA 核准，以及後續的 Medicare 與商業保險給付。Galleri 的檢測效能具高度差異化，偽陽性率低於 0.5%，使其偽陽性數至少比其他開發中的 MCED 檢測少 3 倍至 6 倍。

Our technology at GRAIL was designed specifically for population scale MCED screening. Our extensive research published in top-tier journals concluded that methylation holds the highest biological information density, which is why GRAIL's proprietary methylation platform, the largest of its kind, is uniquely capable of delivering high accuracy detection and precise localization. We have published to our knowledge, the largest head-to-head genomic feature comparison study in the entire field.

GRAIL 的技術是專為大規模族群的 MCED 篩檢所設計。我們在頂尖期刊發表的廣泛研究結論指出，甲基化具有最高的生物資訊密度；因此，GRAIL 的專有甲基化平台（同類中規模最大）能夠以獨特方式提供高準確度的偵測與精準定位。據我們所知，我們已發表本領域規模最大的基因組特徵正面比較（head-to-head）研究。

And we showed that combining other approaches considered did not improve performance over our proprietary methylation technology. Adding these other features only introduced additional complexity, cost and biological noise.

我們也顯示，將其他所考量的方法結合，並未優於我們的專有甲基化技術之效能。加入這些其他特徵只會引入額外的複雜度、成本與生物雜訊。

And the field is increasingly moving to methylation as the technology of choice, further validating our approach. Today in the market with Galleri, we continue to expand access through new and existing partnerships, and we are accelerating our international expansion activities. Related to that, in the second quarter, we completed the previously announced $110 million financing with Samsung.

而整個領域也正日益轉向以甲基化作為首選技術，進一步驗證我們的方法。目前在市場上，透過 Galleri，我們持續藉由新舊合作夥伴擴大可近性，並加速國際擴張活動。與此相關，我們在第二季完成了先前宣布與三星的 1.10 億美元融資。

Alongside that closing, we began work with Samsung C&T Corporation on our strategic collaboration. As a reminder, we and Samsung C&T Corporation will work together to commercialize the Galleri test in South Korea with the potential to expand into additional Asian markets, including Japan and Singapore. The $110 million investment in GRAIL represents a long-term investment to support our growth and international goals.

在完成交割的同時，我們也開始與 Samsung C&T Corporation 就策略性合作展開工作。提醒各位，我們與 Samsung C&T Corporation 將共同在南韓商業化 Galleri 檢測，並有機會擴展至其他亞洲市場，包括日本與新加坡。對 GRAIL 的 1.10 億美元投資，代表一項支持我們成長與國際目標的長期投資。

We were very pleased to complete this financing, and we look forward to moving forward with Samsung to introduce our MCED technology to patients throughout Asia. In the US, we continue to see growing physician adoption of the Galleri test. We sold over 61,000 Galleri tests in the second quarter, a 35% increase in volume year-over-year.

我們非常高興完成此項融資，並期待與三星攜手，將我們的 MCED 技術帶給全亞洲的病患。在美國，我們持續看到醫師對 Galleri 檢測的採用度提升。第二季我們售出超過 61,000 份 Galleri 檢測，檢測量較去年同期成長 35%。

Total Galleri screening revenue was $42.6 million, up 24% over the year prior. For the first half of 2026, we saw Galleri test revenue growth of 30% year-over-year to more than $80 million and Galleri test volume growth of 42% to more than 117,000 tests.

Galleri 篩檢總營收為 4,260 萬美元，較去年同期成長 24%。2026 年上半年，Galleri 檢測營收年增 30% 至超過 8,000 萬美元，Galleri 檢測量年增 42% 至超過 117,000 份。

We announced early in 2026, the planned expansion of our field sales and medical teams based on the positive performance and clinical utility results observed in our PATHFINDER 2 and NHS-Galleri trials. This expansion was substantially complete at the end of the second quarter. New personnel have been onboarded and trained and are now in the field and initial feedback from sales force engagements with physicians since ASCO has been really positive.

我們在 2026 年初宣布，基於 PATHFINDER 2 與 NHS-Galleri 試驗所觀察到的正向效能與臨床效用結果，計畫擴編我們的前線銷售與醫療團隊。此項擴編在第二季末已大致完成。新進人員已完成到職與訓練，現已投入市場；自 ASCO 以來，銷售團隊與醫師互動的初步回饋非常正面。

Last month, we announced a collaboration with Priority Health to enable its employer groups to add the Galleri test to their existing screening coverage. Priority Health is a nationally recognized nonprofit health plan with more than 1.4 million members in Michigan and nearby states. Priority Health launched coverage for Galleri within certain plans in 2025, and our collaboration announced in July marks a promising expansion of this partnership.

上個月，我們宣布與 Priority Health 合作，使其雇主團體能在既有的篩檢給付範圍中加入 Galleri 檢測。Priority Health 是全國知名的非營利健康保險計畫，在密西根州及鄰近州擁有超過 140 萬名會員。Priority Health 於 2025 年在部分方案中啟動 Galleri 給付，而我們於 7 月宣布的合作，標誌著此夥伴關係一項具前景的擴展。

Moving to our clinical evidence base. We recently shared strong clinical utility, performance and safety results from our NHS-Galleri trial and PATHFINDER 2 studies at the recent ASCO Annual Meeting in May. Although the primary endpoint for the NHS-Galleri trial of a combined reduction of Stage III and IV cancers was not met, we believe the other results of the study demonstrated very strong performance, safety and utility. Across both studies, adding Galleri to standard of care increased the cancer detection rate by 4 times to 6.5 times.

接著談我們的臨床證據基礎。我們近期在 5 月的 ASCO 年會上，分享了 NHS-Galleri 試驗與 PATHFINDER 2 研究的強勁臨床效用、效能與安全性結果。儘管 NHS-Galleri 試驗以第三期與第四期癌症合併降低為主要終點未達成，我們相信該研究的其他結果展現了非常強勁的效能、安全性與效用。在兩項研究中，將 Galleri 加入標準照護後，癌症偵測率提升 4 倍至 6.5 倍。

The Galleri test demonstrated very consistent performance with a false positive rate of less than 0.5% and positive predictive values ranging from 50% to 60%. Galleri also demonstrated high accuracy in predicting cancer signal of origin, enabling efficient and patient-centered diagnostic evaluations.

Galleri 檢測展現出非常一致的表現，偽陽性率低於 0.5%，陽性預測值介於 50% 至 60%。Galleri 亦展現出在預測癌症訊號來源方面的高準確度，使診斷評估更有效率且以病患為中心。

Today, standard of care screening finds only about 14% of cancers in the US and about 6% of cancers in the UK. By adding Galleri, we estimate that those figures can increase to 50% or more. And indeed, in PATHFINDER 2, this number was 60%. This represents a substantial improvement that expands detection of clinically meaningful cancers that otherwise lack recommended screening.

目前，標準照護篩檢在美國僅能發現約 14% 的癌症，在英國僅能發現約 6% 的癌症。透過加入 Galleri，我們估計這些數字可提升至 50% 或更高。而且確實地，在 PATHFINDER 2 中，這個數字為 60%。這代表一項重大改善，擴大了對具臨床意義、但原本缺乏建議篩檢的癌症之偵測。

Across these two studies, approximately 40% to 50% of the Galleri detected cancers were found at Stages 1 and 2 and approximately 70% were found at Stages 1 through 3. Remarkably, in the NHS-Galleri study, Galleri detected 366 Stage I and II cancers, many more than the 290 cancers detected at any stage by the entirety of the UK's standard of care screening program in the control arm. This is truly remarkable.

在這兩項研究中，約有 40% 至 50% 由 Galleri 偵測到的癌症是在第 1 與第 2 期被發現，約 70% 則是在第 1 至第 3 期被發現。值得注意的是，在 NHS-Galleri 研究中，Galleri 偵測到 366 例第 I 與第 II 期癌症，遠多於對照組中英國整體標準照護篩檢計畫在任何期別所偵測到的 290 例癌症。這確實非常令人驚豔。

The promise of multi-cancer early detection is not just in finding cancer, but in finding it early enough to open the door to curative treatment options for as many people as possible. What is clear across these groundbreaking trials is that the Galleri test detects a large number of asymptomatic cancers in stages 1 through 3, the majority of which have the opportunity for curative intent treatments.

多癌種早期偵測的承諾不僅在於找到癌症，更在於及早發現，為盡可能多的人開啟可治癒的治療選項之門。在這些突破性試驗中清楚可見，Galleri 檢測能在第 1 至第 3 期偵測到大量無症狀癌症，其中多數都有機會接受以治癒為目的的治療。

Together, these findings underscore the consistency and actionability of the Galleri test results and demonstrate that adding Galleri to standard of care screening has the potential to improve the effectiveness and efficiency of our current national screening program.

綜合而言，這些發現凸顯 Galleri 檢測結果的一致性與可採取行動性，並顯示在標準照護篩檢中加入 Galleri，有潛力提升我們現行國家篩檢計畫的有效性與效率。

This is critical for providers, regulators and payers as they evaluate the clinical and economic value of Galleri alongside standard of care screening. These data support the potential of MCED screening at population scale to identify cancers at earlier stages when treatments are more effective and are potentially curative.

這對於醫療服務提供者、監管機關與支付方在評估 Galleri 與標準照護篩檢並行時的臨床與經濟價值至關重要。這些數據支持 MCED 篩檢在族群規模推行的潛力，可在更早期辨識癌症，此時治療更有效，且可能具有治癒性。

Turning now to our regulatory process. We submitted our premarket approval application to the FDA in early '26, and we remain in an ongoing iterative review process. We are very confident in the data package that's been submitted. Galleri's performance has been validated and replicated in multiple rigorous intended use population level studies.

接下來談我們的監管流程。我們於 26 年初向 FDA 提交上市前核准（PMA）申請，目前仍處於持續、反覆的審查流程中。我們對已提交的數據套件非常有信心。Galleri 的表現已在多項嚴謹、以預期用途族群為基礎的研究中完成驗證並獲得重現。

We have consistently shown that Galleri can detect asymptomatic cancers well over and above the standard of care, and the evidence clearly demonstrates that Galleri can be useful and safe when implemented at scale.

我們一貫證明 Galleri 能在標準照護之上額外偵測到大量無症狀癌症，且證據清楚顯示，當以規模化方式導入時，Galleri 具備實用性與安全性。

Our PMA for Galleri is focused on test performance and safety results from the first approximately 25,000 participants in the PATHFINDER 2 study with one year of follow-up and the prevalent screening round for the first year of the NHS-Galleri trial.

我們針對 Galleri 的 PMA，聚焦於 PATHFINDER 2 研究中前約 25,000 名受試者、追蹤一年之檢測表現與安全性結果，以及 NHS-Galleri 試驗第一年的盛行篩檢輪次。

The submission also includes a bridging analysis to compare performance of the version of Galleri used in these clinical studies to the updated version that has been submitted to the FDA for premarket approval. As Galleri is a first-of-its-kind technology and multi-cancer early detection represents a potential paradigm shift in cancer screening, we do expect the FDA to convene an advisory committee for Galleri in the fall. The FDA will announce specific timing of an advisory committee.

本次提交亦包含一項銜接分析，用以比較這些臨床研究中使用的 Galleri 版本與已提交 FDA 申請上市前核准之更新版本的表現。由於 Galleri 屬首創技術，而多癌種早期偵測可能代表癌症篩檢的典範轉移，我們確實預期 FDA 將於秋季為 Galleri 召開諮詢委員會。FDA 將公布諮詢委員會的具體時程。

Turning now to the evolving market environment. As additional MCED tests have launched, a few things are very critical to mention. Other MCED products have been introduced based only on observational case control data and have yet to evaluate the benefits and harms in an actual screening population.

接下來談不斷演變的市場環境。隨著更多 MCED 檢測上市，有幾點非常關鍵需要說明。其他 MCED 產品僅基於觀察性病例對照數據而推出，尚未在實際篩檢族群中評估其效益與危害。

First, that means it is unknown how the purported benefits of these tests shown in case control data will translate, if at all, into performance when deployed into an asymptomatic screening population. And without interventional studies, it's not clear whether the diagnostic pathways and procedures have been developed to support physicians and patients after a positive test.

首先，這表示目前尚不清楚這些檢測在病例對照數據中所宣稱的效益，是否以及如何能轉化為在無症狀篩檢族群部署時的表現。且在缺乏介入性研究的情況下，也不清楚是否已建立診斷路徑與程序，以在檢測呈陽性後支援醫師與病患。

Second, MCED tests with high false positive rates may expose patients to significant risks of radiation exposure and invasive diagnostic tests, which carry potential for complications and increased morbidity. Until these tests have been robustly studied and validated in the intended use screening population, they represent an unknown benefit risk profile and should be considered experimental screening tests at this stage.

其次，偽陽性率高的 MCED 檢測可能使病患暴露於顯著風險，包括輻射暴露與侵入性診斷檢查，而這些檢查可能帶來併發症與更高的罹病率。在這些檢測於其預期用途的篩檢族群中被充分研究與驗證之前，它們的效益—風險概況仍屬未知，現階段應被視為實驗性篩檢檢測。

When we launched Galleri, we deliberately chose to do so only after reporting results from a prospective interventional study under an FDA-approved investigational device exemption in the screening population. We believe that patients deserve and the field demands this level of robust evidence because the true litmus test performance, both benefits and harms is demonstration in interventional clinical studies in the actual intended use population.

當我們推出 Galleri 時，我們刻意選擇在篩檢族群中、於 FDA 核准的研究用醫療器材豁免（IDE）下完成前瞻性介入研究並報告結果之後，才進行上市。我們相信病患值得、且本領域也要求這樣等級的強健證據，因為真正的試金石——無論效益或危害——是在實際預期用途族群中的介入性臨床研究所證明的表現。

Now why do I say this? This is because case-control data will not always replicate in interventional studies. For example, after a very strong performance for the CancerSEEK assay was observed in a case-controlled study published in a top-tier journal of science, the DETECT-A study failed to replicate performance and safety in an interventional study. And as you know, this test is currently not available or on the market.

那我為什麼這麼說？因為病例對照數據並不總能在介入性研究中被重現。例如，在一項發表於頂尖科學期刊的病例對照研究中，CancerSEEK 檢測呈現非常強勁的表現，但 DETECT-A 研究未能在介入性研究中重現其表現與安全性。而如各位所知，該檢測目前並未提供或上市。

Beyond study rigor, Galleri test characteristics stand apart in the field. Based on data from observational studies that are case controlled, experimental MCED tests are operating at a 3 times to 5 times higher false positive rate. They detect a smaller number of cancer types and some have no ability to predict a cancer signal origin, which we believe is necessary for safety and performance of any MCED test.

除了研究嚴謹度之外，Galleri 的檢測特性也在此領域中脫穎而出。根據屬於病例對照的觀察性研究數據，實驗性 MCED 檢測的偽陽性率高出 3 倍至 5 倍。它們可偵測的癌症類型較少，且部分產品無法預測癌症訊號來源；我們認為這對任何 MCED 檢測的安全性與表現都是必要的。

In a field where hope and hype can easily collide, GRAIL is defined by rigorous science and validated by the most extensive evidence base. We believe we chose the right biological signature of cancer after unbiased comparisons. We have built the most advanced proprietary technology to interpret that signal, and we have proved its performance in the real world on an unprecedented scale.

在一個希望與炒作很容易相互碰撞的領域中，GRAIL 以嚴謹科學為核心，並由最廣泛的證據基礎所驗證。我們相信在不偏不倚的比較後，我們選擇了正確的癌症生物特徵訊號。我們打造了最先進的專有技術來解讀該訊號，並以前所未有的規模在真實世界中證明其表現。

I'll now hand off to Aaron for a review of our second quarter financials.

接下來我將交棒給 Aaron，請他回顧我們第二季的財務表現。

Thanks, Josh, and good afternoon, everyone. Second quarter results were strong with revenue of $44.7 million, up $9.1 million or 26% as compared to the second quarter of 2025. Total revenue for the second quarter consisted of $42.6 million of screening revenue and $2 million of development services revenue.

謝謝你，Josh，各位下午好。第二季結果強勁，營收為 4,470 萬美元，較 2025 年第二季增加 910 萬美元或 26%。第二季總營收包含 4,260 萬美元的篩檢營收與 200 萬美元的開發服務營收。

Screening revenue was up 24% as compared with the second quarter of 2025, with test volumes of more than 61,000, an increase of 35% over the second quarter of 2025. Net loss for the quarter was $110.2 million, a decrease of 3% as compared to the second quarter of 2025.

篩檢營收較 2025 年第二季成長 24%，檢測量超過 61,000 份，較 2025 年第二季增加 35%。本季淨損為 1.102 億美元，較 2025 年第二季減少 3%。

Non-GAAP adjusted gross profit for the second quarter was $21.6 million, an increase of $5.4 million or 34% as compared with the second quarter of 2025. Primary drivers of the increased gross margin were improved fixed cost leverage from higher volumes and a decrease in sample reprocessing costs, partially offset by a decrease in ASP.

第二季的非 GAAP 調整後毛利為 2,160 萬美元，較 2025 年第二季增加 540 萬美元或 34%。毛利率提升的主要驅動因素為：在較高出貨量下固定成本槓桿改善，以及樣本重新處理成本下降；但部分被 ASP 下降所抵銷。

Adjusted EBITDA for the second quarter was negative $90.3 million, an increase in adjusted EBITDA loss of $11.9 million or 15% as compared to the second quarter of 2025. We ended the second quarter with a cash position of $861.6 million, which includes $110 million strategic investment by Samsung, which closed in June. Our cash balance today provides us with financial flexibility as we advance key priorities, including securing regulatory approval and reimbursement for Galleri in the United States.

第二季調整後 EBITDA 為負 9,030 萬美元，較 2025 年第二季調整後 EBITDA 虧損增加 1,190 萬美元或 15%。我們以 8.616 億美元的現金部位結束第二季，其中包含三星 1.10 億美元的策略性投資，該投資已於 6 月完成交割。我們目前的現金餘額為推進關鍵優先事項提供財務彈性，包括在美國為 Galleri 取得監管核准與給付（reimbursement）。

Back to you, Josh.

交回給你，Josh。

Thank you, Aaron. We're really pleased with the continued growth for Galleri and the progress we're making towards FDA approval and broad-based access, and we anticipate continued progress over the next year. With ASCO behind us, our expanded field teams are now fully equipped to educate clinicians about our groundbreaking trial results and continue market development. And initial feedback from the field has been really positive.

謝謝你，Aaron。我們對 Galleri 的持續成長，以及我們在邁向 FDA 核准與廣泛可近性方面取得的進展感到非常振奮，並預期未來一年將持續推進。隨著 ASCO 已告一段落，我們擴編的前線團隊如今已全面就緒，可向臨床醫師說明我們具突破性的試驗結果，並持續推動市場開發。而來自前線的初步回饋非常正面。

We look forward to potential FDA approval of Galleri. Expanding distributor partnerships internationally, progressing R&D on Gallery improvements and cost of goods reduction and publication of the NHS-Galleri and PATHFINDER 2 studies as well as additional analyses from our extensive clinical program.

我們期待 Galleri 可能獲得 FDA 核准。同時也將擴展國際經銷合作夥伴關係、推進 Galleri 改良與降低銷貨成本的研發工作，並發表 NHS-Galleri 與 PATHFINDER 2 研究以及我們龐大臨床計畫的其他分析結果。

Operator, we can now go to Q&A.

接線員，我們現在可以進入問答。

(Operator Instructions)

(接線員指示)

Subbu Nambi, Guggenheim.

Subbu Nambi，Guggenheim。

Hey, team. Thank you for taking my questions. As you anticipate an FDA AdCom in the fall, where do you think the FDA will focus on? Like what type of questions? And how are you preparing for those questions?

嗨，各位。謝謝你們回答我的問題。你們預期秋季會有 FDA 的 AdCom（諮詢委員會）會議，請問你們認為 FDA 會把重點放在哪些方面？例如會問哪些類型的問題？你們又如何為這些問題做準備？

Hi, Subbu. Thank you for the questions. So we are obviously getting ready and preparing internally. We don't know the nature of any of that information at this time, but we should -- obviously, we'll be informed about that as the time approaches. We're waiting to hear something from the FDA as it relates to timing.

嗨，Subbu。謝謝你的提問。我們當然正在內部做準備並積極籌備。目前我們還不知道任何相關資訊的性質，但隨著時間接近，我們應該——當然會被告知相關內容。我們正在等待 FDA 就時程方面給我們進一步訊息。

Okay. That's helpful. And then given all the leadership changes at the FDA and the delays we have seen recently when it comes to finding the right panelists for AdComs, is there a risk this meeting pushes into next year at all? I know it's an unfair question.

好的。這很有幫助。另外，考量到 FDA 領導層的多項變動，以及近期在為 AdCom 尋找合適委員時所見到的延遲，是否存在這場會議被推遲到明年的風險？我知道這問題有點不太公平。

Well, it's fine. We don't know the answer to that question. We know that the division that we're working with has been fairly stable at the FDA, which has been very, very positive and productive. And we continue our iterative review with them. But I couldn't really comment on their ability to find experts.

不會，沒關係。我們不知道這個問題的答案。我們知道我們合作的那個 FDA 部門相對穩定，這非常、非常正面且富有成效。我們也持續與他們進行反覆的審查（iterative review）。但我無法評論他們尋找專家的能力。

Okay. Can I squeeze one more? Would you expect CMS to wait for an FDA approval before better defining the NCD criteria for an MCED test?

好的。我可以再追問一個嗎？你們是否預期 CMS 會在 FDA 核准之前，先更明確界定 MCED 檢測的 NCD（全國給付決定）標準？

Again, it's a good question. I'd be speculating if I try to answer it. We do know that CMS' coverage authority is only for FDA-approved products. So our assumption has been that they would only undertake a national coverage analysis upon an FDA approval. Whether they're going to set specific coverage criteria is unknown.

同樣地，這是個好問題。如果我嘗試回答就會變成推測。我們確實知道，CMS 的給付權限僅適用於已獲 FDA 核准的產品。因此我們的假設一直是，他們只會在 FDA 核准後才會啟動全國給付分析（national coverage analysis）。至於他們是否會設定特定的給付標準，目前仍不清楚。

Thank you so much, guys.

非常感謝，各位。

Kyle Mikson, Canaccord Genuity.

Kyle Mikson，Canaccord Genuity。

Hey, guys. Thanks for the questions. Congrats on the strong quarter. Yeah, following up on Subbu's questions about FDA. So maybe, Josh, like it wasn't clear to me what the specific communication with the FDA was for you to now anticipate the meeting AdCom in the fall. So if you could talk about that, that would be helpful. And then additionally, in the past, you've talked about like an early '27 sort of approval time line. Let's say this is like mid-fall or something. How would that affect your new time line for FDA approval? Thank you.

嗨，各位。謝謝回答問題。恭喜本季表現強勁。我想延續 Subbu 關於 FDA 的問題。所以 Josh，對我來說不太清楚，你們與 FDA 的具體溝通內容是什麼，讓你們現在預期秋季會有 AdCom 會議。如果你能談談這點會很有幫助。另外，過去你們曾提到大概在 2027 年初左右的核准時程。假設 AdCom 是在秋季中段左右。這會如何影響你們新的 FDA 核准時程？謝謝。

No. Thanks for the question, Kyle. We have long stated publicly that we would anticipate that a groundbreaking technology like an MCED test like Galleri that is really changing the potential cancer screening paradigm would get an advisory panel. And we continue to believe that.

不會。謝謝你的問題，Kyle。我們長期以來在公開場合一直表示，像 Galleri 這樣的 MCED 檢測屬於突破性技術，確實正在改變癌症篩檢典範的可能性，因此我們預期會有諮詢委員會（advisory panel）。我們也持續相信會是如此。

There's no specific information that's been made public yet from the FDA about that, but we certainly are anticipating that an AdCom would occur. The timing of it has not been made public yet. So that's still to come. And our current anticipation for potential approval as it relates to timing remains unchanged. We would expect it to occur in the first part of 2027.

目前 FDA 尚未就此對外公布任何具體資訊，但我們確實預期會召開 AdCom。其時點尚未對外公布。因此仍有待後續消息。而我們目前對於可能核准的時程預期仍維持不變。我們預期會發生在 2027 年上半年。

Perfect. Thanks for that. And then on competition, you called that out, that's interesting. It doesn't seem like there's been a volume impact, but how is that impacting your pricing? It looks like ASP in the quarter was $700 or something around there.

很好。謝謝說明。另外關於競爭，你們特別提到這點，這很有意思。看起來出貨量似乎沒有受到影響，但這對你們的定價有什麼影響？看起來本季 ASP 大約是 700 美元左右。

And then kind of on that note, I think USPSTF is meeting later this month. Could they possibly talk about MCED at that meeting? Or how do you think that progresses given it's more noise in the marketplace than some of these other entrants recently?

另外在同一個脈絡下，我想 USPSTF 本月稍晚會開會。他們是否可能在那場會議中討論 MCED？或者你認為在近期其他新進者帶來的市場雜音更大之下，這件事會如何推進？

Yeah, it's a fair question. Let me take your second question, and then I'll have Andy address your first. As it relates to US PSTF, I think there's just a lot that's unknown right now about the USPSTF. It's unknown what its composition is going to be, what its focus will be.

是的，這是個合理的問題。我先回答你的第二個問題，然後請 Andy 回答第一個。就 USPSTF 而言，我認為目前有很多事情仍不明朗。包括其組成會是什麼、焦點會放在哪裡。

And I think without -- before there's an FDA-approved product on the market, it's, in my mind, less likely that they're going to take MCEDs up irrespective of the amount of noise that's in the market or not. But there's just a lot of unknown about the USPSTF and its mandate at this time. Your first question, which was about the impact of competition on our pricing, I'm going to let Andy discuss that.

而且我認為，在市場上尚未有 FDA 核准產品之前，不論市場雜音多或少，他們要把 MCED 納入討論，在我看來可能性較低。但目前對 USPSTF 及其職權（mandate）仍有很多未知。至於你的第一個問題，也就是競爭對我們定價的影響，我會請 Andy 來說明。

Yeah. I think the -- first of all, the ASP decrease in second quarter '26 was the result of expansion of digital health volume and also lower employer pricing, which was planned. That reduced employer pricing has come along with the benefit of strengthened partnerships with those employers such as specific marketing commitments and blood draw events.

是的。我認為——首先，2026 年第二季 ASP 的下降，是數位健康量能擴張以及雇主端定價較低（這是事先規劃的）所致。而這樣的雇主降價，也伴隨著與這些雇主夥伴關係強化的好處，例如特定的行銷承諾與抽血活動。

In terms of competition, there's definitely been some active competition that we've seen that has been stepped up, as I'm sure you've also seen. It has been causing some customer confusion in the market, given, as Josh outlined earlier, these what we would call experimental MCEDs do not have data in the screening population. So many of their performance characteristics are unknown to those prescribing physicians. They also have higher false positive rates.

就競爭而言，確實有一些我們看到的積極競爭行為升溫了，我相信你們也看到了。正如 Josh 先前提到的，這些我們稱之為實驗性的 MCED，並沒有在篩檢族群中的數據，因此在市場上造成了一些客戶困惑。所以它們許多的效能特徵，對於開立檢測的醫師而言是未知的。它們也有較高的偽陽性率。

So what we're seeing with physicians that have experimented with some of these MCEDs is quite a bit of confusion due to these higher false positive rates and unclear performance characteristics. That's something that our sales team are following up with those customers to reinforce Galleri's extensive clinical program that we've conducted and the clinical results that we've presented and published.

因此，我們看到一些曾嘗試使用這些 MCED 的醫師，因為較高的偽陽性率與不清楚的效能特徵而產生相當程度的困惑。我們的業務團隊正在跟進這些客戶，強化傳達我們已完成的 Galleri 大型臨床計畫，以及我們已呈現並發表的臨床結果。

And as Josh said, the initial reactions from these conversations where we followed up with our customers with the data that was presented at ASCO for both PATHFINDER 2 and NHS-Galleri has been very promising and very favorably received.

而且如 Josh 所說，我們在與客戶跟進、並提供在 ASCO 上針對 PATHFINDER 2 與 NHS-Galleri 所呈現的數據後，這些對話的初步反應非常令人鼓舞，且獲得非常正面的回饋。

That's great, Andy. I would just add one other thing. The noise that's been interjected into the market, we expect that our anticipation is that we will have an FDA approval, and that will create a bifurcation in the market and clear up a lot of that noise.

很好，Andy。我再補充一點。市場上被注入的雜訊，我們預期——我們的判斷是——我們將取得 FDA 核准，而這將使市場出現分化，並釐清許多雜訊。

We expect the market really to evolve one side with Galleri as a well-validated and potentially FDA-approved MCED and then the other side of the market with the other MCEDs that are still, quite frankly, in development with unknown risk-benefit profiles in the intended use population. And so they'd be considered very experimental. So we see that bifurcation coming, and we look forward to executing upon it.

我們預期市場將真正演變為兩邊：一邊是 Galleri，作為經充分驗證、且可能獲得 FDA 核准的 MCED；另一邊則是其他 MCED，坦白說仍在開發中，在目標使用族群中的風險—效益輪廓未知。因此它們會被視為非常實驗性。所以我們看到這種分化即將到來，也期待能夠加以落實執行。

Bradley Bowers, Mizuho.

Bradley Bowers，Mizuho。

Hey, thanks for taking my questions. Maybe just wanted to click on the sales force expansion, obviously, a pull forward of some of the costs. Just wanted to hear about why the timing is right. Seemingly the first part of 2027 timeline seems coincident with expected productivity ramp. But also just wanted to hear about if you knew about the AdCom scenario from the FDA kind of when you allocated the size and if this is kind of the max sales force used up?

嗨，謝謝讓我提問。我想追問一下銷售團隊擴編，顯然是把部分成本提前認列。想聽聽為什麼現在的時點是對的。看起來 2027 年上半年的時間軸似乎與預期的生產力爬坡相吻合。另外也想了解，你們在配置規模時是否已經知道 FDA 可能召開 AdCom 的情境？以及這是否已經是動用的最大銷售團隊規模？

Yeah, we pulled forward the sales force expansion really on the back of the NHS-Galleri and PATHFINDER 2 data that we announced earlier in the year. given how excited we were with both sets of that data. That sales force expansion is essentially complete now. Those sales members are now in the field. We expect to see the true benefit of that additional sales force horsepower as we go through the rest of the year.

是的，我們把銷售團隊擴編提前，主要是基於我們今年稍早公布的 NHS-Galleri 與 PATHFINDER 2 數據，因為我們對這兩組數據都非常振奮。這次銷售團隊擴編現在基本上已經完成。這些新加入的業務成員已經在第一線。我們預期在今年接下來的時間裡，會看到這額外銷售戰力帶來的真正效益。

And the other reason that we did this is to have those new salespeople in territory, all trained so that they can truly meet the moment of FDA approval, as Josh outlined, as this is going to be a landmark event for GRAIL, really establishing Galleri as the gold standard MCED.

我們這麼做的另一個原因，是讓這些新業務人員能在各自的區域就位並完成訓練，這樣一旦 FDA 核准的時刻到來——如 Josh 所說——他們就能真正把握這個時機；這將是 GRAIL 的里程碑事件，確立 Galleri 作為 MCED 的黃金標準。

Got it. And just real quick, would you give a number just because of competitors we do know a lot of them. And then just actually totally switching gears. On the panel, do you think this would make it may be easier or harder for the incremental MCED test, asking just because the government initiative right now seems to be just trying to ease the pathway towards getting MCED tests, adding more to the market.

了解。那能否給個數字？因為競爭對手我們其實知道不少。另外我完全換個話題。關於委員會（panel），你覺得這會讓後續新增的 MCED 檢測更容易還是更困難？我這樣問是因為政府目前的倡議似乎是想要降低 MCED 檢測進入市場的門檻、讓市場上有更多產品。

But obviously, the panel would be kind of differentiated. So I wanted to hear if you think it would be kind of a competitive advantage, kind of an extra barrier to entry or if it might have the adverse effect of making it easier for other MCEDs down the line? Thank you for the questions.

但顯然，這個 panel 會有其差異化。所以我想聽聽你是否認為這會成為一種競爭優勢、形成額外的進入障礙；或反而可能產生不利效果，讓未來其他 MCED 更容易進入？謝謝你回答問題。

Just to clarify, when you say a panel, do you mean an advisory committee panel?

我先確認一下，你說的 panel 是指諮詢委員會（advisory committee）會議嗎？

Sorry, I apologize. Yeah, this fall, the meeting this fall.

抱歉，我道歉。是的，今年秋天的那場會議。

Yeah. No, an AdCom, look, the reason we expect an AdCom is because typically, when the FDA reviews a kind of groundbreaking pioneering type of technology, particularly one that could have this kind of impact on public health that is really paradigm changing. They typically hold an AdCom because they want to get advice from other experts.

是的。不，AdCom——你看，我們之所以預期會有 AdCom，是因為通常 FDA 在審查一種突破性、開創性的技術時，特別是可能對公共衛生產生這種影響、真正改變典範的技術，他們通常會召開 AdCom，因為他們希望聽取其他專家的建議。

The AdCom will be completely about Galleri. It will not be about the field of MCEDs. It won't be about other MCEDs. It will be just about our data package that we submitted to the FDA. So we don't really view it as a competitive advantage or disadvantage.

這場 AdCom 將完全聚焦在 Galleri。不會是關於 MCED 這個領域。也不會談其他 MCED。只會針對我們提交給 FDA 的數據資料包。所以我們不太把它視為競爭優勢或劣勢。

We view it as part of the FDA approval process for a groundbreaking technology like Galleri. I mean to your further question, I don't think that, that has necessarily any bearing on whether there will be AdComs for future MCEDs. And I don't see any MCEDs right now even on the horizon and doing registrational trials or anything like that. So it's really hard to say.

我們把它視為像 Galleri 這種突破性技術在 FDA 核准流程中的一部分。至於你延伸的問題，我不認為這必然會影響未來的 MCED 是否會有 AdCom。而且我目前也看不到有任何 MCED 即將進入視野、在做註冊性試驗或類似的事情。所以真的很難說。

Yeah. And I think just building on Josh's point, what the AdCom and the FDA approval is going to do is establish that approval bar for future MCEDs. And that's why we're excited for this panel and for the anticipated FDA approval that it is going to set that bar for future MCEDs coming forward.

是的。我想在 Josh 的觀點上再補充，AdCom 與 FDA 核准將會做的一件事，是為未來的 MCED 建立核准門檻。這也是我們對這場委員會會議以及預期的 FDA 核准感到興奮的原因，因為它將為未來推出的 MCED 設定那個門檻。

Dan Brennan, TD Cowen.

Dan Brennan，TD Cowen。

Great. Thanks. Congrats on the quarter. Thanks for the questions. Maybe just one more on the panel since it's obviously the topic to Josh -- so Josh, you sounded pretty definitive that there will be a panel. The FDA will alert us when -- kind of when the time is right.

很好。謝謝。恭喜這一季的表現。謝謝讓我提問。既然 panel 顯然是焦點，我再問一個關於 panel 的問題給 Josh——Josh，你聽起來相當肯定會有一場 panel。FDA 會在——大概在時機成熟時——通知我們。

Can you just share any color like -- so does that mean like an outright decision popping up one day is off the table? Like just what's the level of the discussions that you have with FDA under these types of processes? And just anything you could share on that front would be helpful.

你能否再多分享一些細節——所以這是否意味著某一天突然出現一個直接的決定（out-right decision）這種情況就不太可能？像在這類流程下，你們與 FDA 的討論層級大概是什麼樣子？任何你能分享的資訊都會很有幫助。

Yeah. There's not a lot we can share until the FDA decides to make a public pronouncement one way or the other. But from the very outset, we have been anticipating an AdCom. We've stated that numerous times. we don't see any reason why that wouldn't be the case.

是的。在 FDA 決定以某種方式對外公開表態之前，我們能分享的不多。但從一開始，我們就一直預期會有 AdCom。我們也多次這麼說過。我們看不出有任何理由不會如此。

And so really, it's just our own internal preparation at this point until the FDA decides to make a public pronouncement. But we're prepared for one. We continue to prepare. We feel very confident about the evidence package that we've submitted to the FDA.

因此，實際上在此刻，在 FDA 決定對外公開發表聲明之前，這只是我們內部的準備工作。但我們已經為此做好準備。我們會持續準備。我們對已提交給 FDA 的證據資料包非常有信心。

We've been in a very productive, iterative review process and going through all the relevant steps of inspections and other things that you would expect going into a PMA. So things are progressing well, and we look forward to hearing more from the FDA.

我們一直處於非常具成效、反覆迭代的審查流程中，並且完成了所有與 PMA 相關、你會預期會進行的檢查與其他事項。因此進展良好，我們也期待從 FDA 聽到更多消息。

Great. Thank you. Is there anything you can share about the back and forth like in terms of -- obviously, you can't get into specifics, but I'm sure there's a certain cadence of questions and responses, but I'm not sure how you might categorize those if there's anything you could share on that front?

很好。謝謝。關於來回溝通的情況，你能分享些什麼嗎——顯然你不能談細節，但我想一定有某種提問與回覆的節奏；只是我不確定你會如何歸類。如果在這方面有任何可以分享的內容？

Not really. I mean it's pretty typical. There have been a series of questions. We've responded. There's been a series of inspections. We've performed through those. And so it's just a very standard process, not much I can really share.

不太能。我的意思是，這相當典型。有一系列問題。我們已回覆。也有一系列稽查。我們都順利通過。所以這就是非常標準的流程，沒有太多我真的能分享的。

Okay. How about the marketing since ASCO? I know that you guys were kind of held back a bit from being out in the field since the NHS-Galleri headline was out, but you wanted to wait until you presented the full data set at ASCO.

好的。那 ASCO 之後的行銷呢？我知道自從 NHS-Galleri 的標題消息出來後，你們在外勤推廣方面有點被迫收斂，但你們想等到在 ASCO 發表完整資料集之後再說。

Now that, that was out, can you just share any color about how -- like what the plan has been in the last six weeks or so or eight weeks, excuse me, -- what have you guys done? How many customers have you hit? What's been the response? Anything on that front to kind of provide color on?

現在那已經公布了，你能否分享一些背景資訊——例如過去大約六週左右或八週（抱歉）——你們做了哪些事？接觸了多少客戶？反應如何？在這方面有沒有什麼可以補充的？

Yeah. We trained all of the sales force the week after the ASCO meeting. So we plan to do that. We also trained all of our new sales force that we brought on board in terms of the sales force expansion. And our sales teams have been out there talking to customers, both health care providers and to employer customers.

可以。我們在 ASCO 會議後的那一週完成了全體銷售團隊的訓練。這是我們原本就規劃要做的。此外，針對我們因擴編而新加入的銷售人員，我們也完成了訓練。目前我們的銷售團隊已在外與客戶溝通，客戶包含醫療照護提供者以及雇主客戶。

The reaction has been very favorable from customers as we've explained to them, both the PATHFINDER 2 data and the NHS-Galleri data, really establishing that Galleri is the only MCED proven to reduce Stage 4 diagnoses and physicians have reacted very favorably to that. And really, this has been the promise of Galleri all along to increase early-stage detection and reduce late-stage detection, enabling more patients to receive curative intent therapy. So everything very promising up until this point.

當我們向客戶說明 PATHFINDER 2 的資料與 NHS-Galleri 的資料時，客戶反應非常正面；這些資料確立了 Galleri 是唯一被證實能降低第四期（Stage 4）診斷的 MCED，而醫師對此反應也非常正向。而且，這一直以來就是 Galleri 的承諾：提升早期分期的偵測、降低晚期分期的偵測，讓更多病患能接受以治癒為目的的治療。所以截至目前一切都非常令人振奮。

Yes, I was in the field recently as well, speaking with clinicians and practicing providers. And when they hear the results of the study, like we found Galleri found more early Stage I and II cancers in the NHS trial than the entire number of cancers found by the UK's national screening program is pretty remarkable. And I think it has quite an impact -- we also found that there was a dramatic increase in the Stage 1 and 2 screen detected cancers in the Galleri arm compared to the control arm in NHS-Galleri.

是的，我最近也到第一線，與臨床醫師與執業醫療提供者交流。當他們聽到研究結果，例如在 NHS 試驗中，Galleri 在第一期與第二期早期癌症的偵測數量，竟然超過英國國家篩檢計畫所偵測到的全部癌症數量，這相當驚人。我認為這帶來很大的影響——我們也發現，在 NHS-Galleri 中，與對照組相比，Galleri 組在篩檢偵測到的第一期與第二期癌症數量有顯著增加。

And then, of course, there was a 6.5-fold increase in the overall cancer detection rate in PATHFINDER 2 when added to standard of care. And so when you talk to doctors about those kinds of numbers, you get a very positive reaction.

此外，當 PATHFINDER 2 加入標準照護後，整體癌症偵測率提高了 6.5 倍。因此，當你和醫師談到這類數字時，通常會得到非常正面的回應。

And Andy's point is I want to underscore it. The whole purpose of screening for cancer is to give individuals an opportunity to find cancer in stages that have curative intent opportunities. And in PATHFINDER 2, for example, the vast majority of Galleri detected cancers received curative intent treatment.

而 Andy 的觀點我想再強調一次。癌症篩檢的核心目的，是讓個人有機會在仍有治癒意圖治療機會的分期發現癌症。例如在 PATHFINDER 2 中，Galleri 偵測到的癌症絕大多數都接受了以治癒為目的的治療。

Great. And maybe just I'll sneak two more in. Publication, just latest thoughts there, timing, when we might expect the data to be in a leading journal?

很好。我再偷偷問兩個。關於論文發表，最新想法是什麼？時程上，我們何時可能在頂尖期刊看到這些資料？

Yeah, Harp here. Thanks, Dan. So we have submitted publications both on PARFNDER-2 and NHS-Galleri. Those have been in active review at top-tier journals, and those review processes are going well, and they're going quickly. And so we are hopeful of publication in the near future.

我是 Harp。謝謝，Dan。我們已提交了關於 PARFNDER-2 與 NHS-Galleri 的論文。目前都在頂尖期刊進行積極審查，審查流程進展順利且速度很快。因此我們希望在不久的將來能夠發表。

Great. And then maybe -- so assuming FDA approval comes at some point this fall or early next year, obviously, Medicare will have to follow the decision there. But in the interim, what type of impact will FDA approval do you think have upon either did some payers adopt then?

很好。接著，假設 FDA 核准在今年秋季或明年初的某個時間點到來，顯然 Medicare 之後也必須跟進做出決定。但在此期間，你認為 FDA 核准會對業務帶來什麼影響？例如是否會有一些保險支付方因此採用？

Will maybe self-insured plans look to do anything, volumes? Just what's the meaning of FDA approval, do you think on the business, say, like in that 12-month period between that decision and when the Medicare decision comes?

自保型（self-insured）方案是否會想採取任何行動、帶動量能？也就是說，在該決定與 Medicare 決定之間大約 12 個月的期間內，你認為 FDA 核准對業務的意義是什麼？

Yeah. Thanks for the question. So FDA approval is really the gate that a lot of payers have been waiting for to really dig into Galleri and serious conversations. So we're looking forward to that. Also, many employers have told us that they're waiting for FDA approval as well. So that's going to put a wind at our backs with both employers and with payers going forward.

好的。謝謝你的問題。FDA 核准其實是許多支付方一直在等待的一道門檻，讓他們能真正深入了解 Galleri 並展開嚴肅的對話。所以我們非常期待。另外，許多雇主也告訴我們，他們同樣在等待 FDA 核准。因此，這將在未來與雇主及支付方的推進上，成為我們的助力。

And then, of course, health care providers. Josh and I have talked about the confusion that's being caused by experimental MCEDs promoting their unproven tests. FDA approval is going to give providers the confidence that Galleri is the gold standard MCED. So we feel that that's also going to give our sales teams a lot of confidence going forward in terms of their sales efforts to provider clinics.

當然還有醫療照護提供者。Josh 和我談過，目前一些實驗性 MCED 以未經證實的檢測進行宣傳，造成了混淆。FDA 核准將讓提供者更有信心，認定 Galleri 是 MCED 的黃金標準。因此我們也認為，這會在未來銷售團隊對提供者診所的銷售推進上，帶來更大的信心。

Terrific. Thank you, all.

太好了。謝謝各位。

David Westenberg, Piper Sandler.

David Westenberg，Piper Sandler。

Hey, guys. It's Karan Patel on for David Westenberg. And I'll maybe shift gears here. If you could speak to the Illumina royalty resuming sometime in Q4, how can we think about margins for Q4 and then specifically for full year '27?

嗨，各位。我是代替 David Westenberg 的 Karan Patel。我可能在這裡換個話題。如果你們能談談 Illumina 權利金在第四季某個時間點恢復支付，我們該如何看待第四季的毛利率，以及特別是 2027 全年的毛利率？

Yeah, Karan. So that royalty will kick in towards the end of Q4. So I wouldn't -- it's not going to have an impact on Q4 in any meaningful way. And we've been disclosing what that royalty would be every quarter. So far in our -- in the financials, so you can see what that would have been if we had been paying it. We disclosed in the financials, it's 7% to 9%, 7% royalty, I believe. And you can do your modeling to see what the impact would be based off of the volumes that you're expecting in the ASPs. So minimal for 4Q.

好的，Karan。那筆權利金會在第四季接近尾聲時開始生效。所以我不會——它不會在第四季對業績造成任何有意義的影響。而且我們每一季都已揭露那筆權利金會是多少。到目前為止在我們的——在財報中，所以你可以看到如果我們當時有支付，會是什麼樣子。我們在財報中揭露的是 7% 到 9%，我記得是 7% 的權利金。你可以依據你預期的出貨量與 ASP（平均售價）自行建模，來看其影響。因此對第四季影響很小。

Understood. Thank you so much for 4Q. Got it.

了解。非常感謝 4Q。明白了。

Kallum Titchmarsh, Morgan Stanley.

Kallum Titchmarsh，摩根士丹利。

Yeah. Great. Thanks for taking the questions. Sorry again to move back to the AdCom. I was just reading through the transcript from the Q4 call back in February. And the message did seem to be that you were prepping for an AdCom, but one likely wasn't necessary.

是的。很好。感謝接受提問。也再次抱歉把話題拉回到 AdCom。我剛剛在讀二月那次第四季電話會議的逐字稿。當時的訊息似乎是你們正在為 AdCom 做準備，但很可能並不需要。

So I'm still just trying to unpackage what perhaps has changed maybe from the questions that you've had from the FDA to the tone that you've given today. And I realize you can't perhaps go into too many of the specifics, but just some guidance would be helpful.

所以我仍在試著釐清，可能有哪些地方改變了——也許是 FDA 提出的問題，或是你們今天所呈現的語氣。我知道你們可能無法談太多細節，但若能給一些指引會很有幫助。

That's fair. There's nothing that's changed in our minds or in our point of view about the FDA AdCom. I'm not sure what you're reading into prior comments. We've been very consistent saying that we are expecting that there will be an AdCom, and we still expect that, and we're fully prepared for that. In fact, we look forward to the opportunity to really discuss this data package, which is unprecedented in performance and scale with the AdCom.

這很合理。就 FDA 的 AdCom 而言，我們的想法或觀點沒有任何改變。我不確定你從先前的評論中解讀到了什麼。我們一直非常一致地表示，我們預期會有 AdCom，我們現在仍然這麼預期，而且我們已完全做好準備。事實上，我們也期待能有機會與 AdCom 充分討論這份在表現與規模上都前所未有的數據資料包。

Okay. Fair enough. And then some pretty sizable financing completed with Samsung in the quarter. Can you maybe just speak to the level of engagement there and how we should be thinking about the regulatory and commercial time lines in South Korea, Japan and Singapore? Thank you.

好的。明白。另外，本季與三星完成了一筆相當可觀的融資。你能否談談雙方互動的投入程度，以及我們應該如何看待在南韓、日本與新加坡的法規與商業時程？謝謝。

Yeah, it's Aaron again. Yeah, so we closed that in for the end of the quarter, and we're just kicking off those discussions now around distribution in the near term and then any sort of longer-term strategic engagement. As you recall, we were under CFIUS review during that period, and we weren't engaging with each other as such. So we'll be able to provide more color on that as we move through the year.

是的，我是 Aaron。是的，我們在季度末完成了交割，現在才剛開始就短期的通路/經銷，以及任何較長期的策略性合作展開討論。如你所記得的，那段期間我們正接受 CFIUS 審查，因此彼此並未進行互動。所以隨著今年推進，我們會提供更多相關細節。

Robert Bamberger, Baird.

Robert Bamberger，Baird。

Hi, guys. This is [Josh] on for Rob. I guess, first, another solid quarter for Galleri here. What was the primary growth driver in the quarter? Was this more on new physician adds or improving order rates among existing physicians? Thanks.

嗨，各位。我是代 Rob 提問的 [Josh]。我想先問，Galleri 本季又是一個穩健的季度。本季主要的成長驅動因素是什麼？是新增醫師數較多，還是既有醫師的下單率提升？謝謝。

Self-pay remains the majority of Galleri's volume, accounting for about 70% of sales. We see that most of the volumes coming from brick-and-mortar physicians, and we added, again, about 1,000 new ordering providers in Q2.

自費仍占 Galleri 量體的大宗，約占銷售額的 70%。我們看到大部分量體來自實體診所的醫師，而我們在第二季又新增了約 1,000 位新的開立/下單醫療提供者。

Depth of prescribing continues to increase over time. Electronic order integrations with Quest and Athena are also both bringing on new prescribers themselves and helping increase the depth of prescribing as well, given we don't just want to have the best performing tests and the gold standard MCED.

處方深度（prescribing depth）隨時間持續提升。與 Quest 與 Athena 的電子下單整合，也同時帶來新的開立者，並在我們不僅希望擁有表現最佳的檢測與 MCED 金標準的前提下，協助提升處方深度。

We also want to have the easiest test for prescribers to prescribe to their patients. We also continue to see very strong growth in our digital health business from both new and existing digital health partners. We've seen continued expansion in employers that are offering the test and also expansion in some new digital health partners. And also, as we announced expansion in our payer partnerships with Priority Health now joining a number of other ASO payers who have decided to offer the Galleri test to their employer base of customers.

我們也希望這是讓開立者最容易為病患開立的檢測。我們也持續看到數位健康業務在新的與既有的數位健康合作夥伴帶動下維持非常強勁的成長。我們看到提供該檢測的雇主持續擴增，也看到一些新的數位健康合作夥伴加入。此外，如我們所宣布的，付款方合作也有所擴大，Priority Health 現在加入了其他多家 ASO 付款方之列，決定向其雇主客戶群提供 Galleri 檢測。

Great. And I was just wondering, too, with the NHS, how have discussions here gone around expanded Galleri studies or future collaborations? Do you have any concerns around the ongoing NHS reform? How is that impacting Galleri and diagnostic aid for cancer conversations? Thanks.

很好。另外我也想請教，關於 NHS，你們在擴大 Galleri 研究或未來合作方面的討論進展如何？你們是否對正在進行的 NHS 改革有任何疑慮？這對 Galleri 以及癌症診斷輔助相關的討論有何影響？謝謝。

Yeah. Thanks for the question, Josh. So look, the there's no getting around the fact that the fundamental changes in the sort of organizational structure and governance for NHS services in the UK is causing some hiatus in decision-making and what those future structures will look like, and there's still an enormous amount of uncertainty around that and quite a lot of organizational upheaval that's flowing from that.

是的。謝謝你的問題，Josh。坦白說，英國 NHS 服務在組織架構與治理方面的根本性變革，確實導致決策出現一些停滯，未來架構會長什麼樣仍存在大量不確定性，也引發相當程度的組織動盪。

What I will say is that as we have talked to the leading clinicians in the NHS and indeed clinicians more generally in the UK the overwhelming reaction is one of positivity about the results. Really, as Andy has described for the US, we're seeing a great deal of enthusiasm around the Stage 4 reduction and some of the other metrics that we've talked about, but particularly the Stage 4 reduction and the opportunity that promises to really transform cancer outcomes. So look, as we get through this, as I say, this organizational upheaval with the NHS, I would anticipate those conversations will translate into defining hopefully a meaningful way forward.

但我要說的是，當我們與 NHS 的領導臨床醫師、以及更廣泛的英國臨床醫師交流時，壓倒性的反應都是對結果持正面態度。確實如 Andy 對美國所描述的，我們看到大家對第四期（Stage 4）降低以及我們談到的其他一些指標抱持高度熱忱，但尤其是第四期降低，以及其有望真正改變癌症結果的機會。因此，隨著我們度過這段 NHS 的組織動盪期，我預期這些對話將轉化為界定一條希望具有實質意義的前進方向。

Thank you. There are no further questions at this time. Ladies and gentlemen, this concludes the call. You may now disconnect.

謝謝。目前沒有其他問題。各位女士、先生，本次電話會議到此結束。您現在可以掛線。