Grail Inc (GRAL) 2025 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the GRAIL third-quarter 2025 earnings call. (Operator Instructions) Please be advised that this conference call is being recorded.

各位女士、先生，大家好，歡迎參加 GRAIL 2025 年第三季財報電話會議。（操作員說明）請注意，本次電話會議正在錄音。

GRAIL Investor Relations, please begin.

GRAIL投資者關係部，請開始。

Thanks, operator, and thanks, everyone, for joining us today. On the call are Bob Ragusa, our Chief Executive Officer; Aaron Freidin, Chief Financial Officer; Josh Ofman, President; Sir Harpal Kumar, Chief Scientific Officer and President, International; and Andy Partridge, Chief Commercial Officer. We'll be making forward-looking statements on this call 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 contained in Section 27A of the Securities Act of 1933 as amended and Section 21 of the Securities Exchange Act of 1934 as amended.

謝謝接線員，也謝謝各位今天收看我們的節目。參加電話會議的有：執行長 Bob Ragusa；財務長 Aaron Freidin；總裁 Josh Ofman；首席科學官兼國際總裁 Harpal Kumar 爵士；以及首席商務官 Andy Partridge。我們將在本次電話會議上根據目前的預期發表一些前瞻性聲明。我們意圖使除歷史事實陳述以外的所有陳述，包括有關我們預期財務業績和商業活動的陳述，都受到經修訂的 1933 年證券法第 27A 條和經修訂的 1934 年證券交易法第 21 條中關於前瞻性陳述的安全港條款的保護。

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. 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 SEC, including the Risk Factors section in GRAIL's most recent quarterly report on Form 10-Q.

前瞻性陳述存在風險和不確定性。實際事件或結果可能與預測或討論的內容有重大差異。所有前瞻性陳述均基於目前可獲得的信息，GRAIL 不承擔更新這些陳述的義務。為了更了解可能導致實際結果出現差異的風險和不確定性，我們建議您參閱 GRAIL 向美國證券交易委員會提交的文件，包括 GRAIL 最新季度報告（10-Q 表格）中的「風險因素」部分。

This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss, which are adjusted to exclude certain specified items. 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 posted to our website.

本次電話會議也將討論 GAAP 結果和某些非 GAAP 財務指標，包括調整後的毛利或虧損，這些指標已進行調整以排除某些特定項目。我們的非GAAP財務指標旨在幫助您更了解GRAIL的財務狀況。今天發布的新聞稿中提供了非GAAP指標與最直接可比較的GAAP財務指標的調節表，該新聞稿已發佈在我們的網站上。

And with that, we can turn to Bob.

接下來，我們可以把目光轉向鮑伯了。

Good afternoon, everyone, and thank you for joining us. On today's call, we will review third-quarter results and discuss recent updates. These include PATHFINDER 2 results shared at ESMO, updated SYMPLIFY data shared at EDCC, and recent strategic and financing activities.

各位下午好，感謝各位的參與。在今天的電話會議上，我們將回顧第三季業績並討論近期最新進展。其中包括在 ESMO 上分享的 PATHFINDER 2 研究結果、在 EDCC 上分享的更新後的 SYMPLIFY 數據，以及最近的策略和融資活動。

We remain very pleased with our commercial progress. Growth in Galleri volumes and revenue in the third quarter of 2025 were 39% and 29%, respectively, as uptake continues to grow. From the launch of Galleri through September 30, approximately 420,000 Galleri commercial tests have been sold by more than 16,000 healthcare providers.

我們對自身的商業進展仍然非常滿意。2025 年第三季度，Galleri 的銷售和收入分別成長了 39% 和 29%，市場需求持續成長。從 Galleri 推出到 9 月 30 日，已有超過 16,000 家醫療保健機構售出了約 42 萬份 Galleri 商業檢測產品。

We are continuing to progress our activities beyond the United States as well, recently announcing a strategic collaboration with Samsung to bring the Galleri test to key Asian markets. Subject to execution of definitive agreements, we and Samsung will work as exclusive partners to commercialize Galleri in South Korea and potentially other Asian markets, including Japan and Singapore. In addition, we plan to explore other strategic and operational collaborations. Samsung has also agreed to make an equity investment of $110 million in GRAIL, subject to closing conditions.

我們也不斷拓展美國以外的業務，最近宣布與三星達成策略合作，將 Galleri 測試引入亞洲主要市場。在簽署最終協議的前提下，我們和三星將作為獨家合作夥伴，在韓國以及可能包括日本和新加坡在內的其他亞洲市場推廣 Galleri 產品。此外，我們計劃探索其他策略和營運方面的合作。三星也同意向 GRAIL 進行 1.1 億美元的股權投資，但需滿足成交條件。

In October, we also introduced Galleri commercially in Canada in partnership with Medcan, a global leader in proactive health and wellness services. Eligible adults in Canada may now access the Galleri test at Medcan's clinics.

10 月，我們還與全球領先的主動式健康和保健服務提供者 Medcan 合作，在加拿大推出了 Galleri 產品。加拿大符合條件的成年人現在可以在 Medcan 的診所接受 Galleri 檢測。

In addition to these operational updates, we recently completed a $325 million private placement. This transaction strengthens our balance sheet as we progress through additional milestones. Galleri is the only MCED available, which has demonstrated performance in people being screened in the intended use population. This includes data from our registrational PATHFINDER 2 study, where a pre-specified analysis was presented at ESMO last month.

除了這些營運方面的更新之外，我們最近還完成了一筆 3.25 億美元的私募融資。隨著我們不斷邁向新的里程碑，這筆交易將增強我們的資產負債表。Galleri 是目前唯一可用的 MCED，已在目標用戶群的篩選中證明了其效能。這包括我們註冊性 PATHFINDER 2 研究的數據，其中一項預先設定的分析已於上個月在 ESMO 會議上公佈。

I'll ask Josh then Harpal to discuss recent results from Galleri's clinical program.

我將請 Josh 和 Harpal 討論 Galleri 臨床計畫的最新成果。

Thank you, Bob, and hi, everybody. We were really pleased last month to share very positive performance and safety results from the pre-specified analysis of the first 25,000 participants in our registrational PATHFINDER 2 study.

謝謝你，鮑勃，大家好。上個月，我們非常高興地分享了 25,000 名註冊性 PATHFINDER 2 研究的參與者的預先設定的分析結果，結果顯示療效和安全性都非常積極。

This study started in 2021, and PATHFINDER 2 is a large prospective trial in a very broad and diverse enrolled group representative of Galleri's screening eligible intended use population. Releasing the first results of this study at ESMO was so exciting and a big milestone for our company and all of our partners and investigators, and it was a meaningful contribution to the evidence base for the effectiveness of multi-cancer early detection.

這項研究始於 2021 年，PATHFINDER 2 是一項大型前瞻性試驗，納入了非常廣泛且多樣化的受試者群體，代表了 Galleri 符合篩檢條件的預期使用人群。在 ESMO 上發布這項研究的初步結果令人非常興奮，對於我​​們公司、所有合作夥伴和研究人員來說都是一個重要的里程碑，並且對多癌症早期檢測的有效性證據基礎做出了有意義的貢獻。

As you'll recall, we found that adding Galleri to recommended screening for breast, cervical, colorectal, and lung cancer yielded a more than sevenfold increase in the overall cancer detection rate. Approximately three-fourths of the cancers detected by Galleri have no recommended screening options. And more than half of the new cancers detected by Galleri were in Stage 1 or 2 and more than two-thirds were detected at Stages 1, 2 or 3.

您可能還記得，我們​​發現，在建議的乳癌、子宮頸癌、大腸癌和肺癌篩檢中加入 Galleri，可將癌症整體檢出率提高七倍以上。Galleri 檢測到的癌症中，約有四分之三沒有建議的篩檢方案。Galleri 檢測出的新癌症中，超過一半處於 1 期或 2 期，超過三分之二處於 1 期、2 期或 3 期。

One of the most important clinical metrics, the positive predictive value, or PPV, which is the likelihood of receiving a cancer diagnosis following a positive test result, Galleri's PPV was 61.6%. Specificity was 99.6%, translating to a false positive rate of 0.4%, a critical safety metric. Galleri's ability to accurately identify where in the body the cancer is located also helped guide an efficient and effective diagnostic evaluation. Importantly, there were no serious study-related adverse events reported thus far.

最重要的臨床指標之一是陽性預測值（PPV），即檢測結果呈陽性後確診癌症的可能性，Galleri 的 PPV 為 61.6%。特異性為 99.6%，假陽性率為 0.4%，這是關鍵的安全指標。Galleri能夠準確地識別癌症在體內的位置，這也有助於指導高效的診斷評估。值得注意的是，目前尚未報告任何與研究相關的嚴重不良事件。

Diagnostic resolution, an important economic and patient-centered outcome measure took a median of 46 days, and only 0.6% of all participants had an invasive procedure. And again, no serious study-related adverse events were reported. Invasive procedures were 2 times more common in participants ultimately diagnosed with cancer than in those who are ultimately not diagnosed with cancer.

診斷解決是重要的經濟和以患者為中心的結果指標，平均耗時 46 天，所有參與者中只有 0.6% 接受了侵入性手術。此外，沒有報告任何與研究相關的嚴重不良事件。最終被診斷出患有癌症的參與者接受侵入性手術的機率是最終未被診斷出患有癌症的參與者的 2 倍。

PATHFINDER 2 and NHS Galleri make up our registrational clinical program for Galleri. Our PMA submission will include these data from the first 25,000 enrolled in PATHFINDER 2 to complete 12 months of follow-up, plus findings from the prevalent round of screening from the NHS Galleri randomized clinical trial as well as the results of a bridging study between the version of Galleri used in the two registrational trials to the updated version that we plan to submit to the FDA for pre-market approval.

PATHFINDER 2 和 NHS Galleri 構成了我們 Galleri 的註冊臨床計畫。我們的 PMA 申請將包括 PATHFINDER 2 中前 25,000 名參與者完成 12 個月隨訪的數據，以及 NHS Galleri 隨機臨床試驗中普遍篩檢的結果，以及在兩項註冊試驗中使用的 Galleri 版本與我們計劃提交給 FDA 以獲得上市前批准的更新版本之間的橋接研究結果。

As a reminder, we announced positive top-line results from the prevalent round of screening in the NHS Galleri trial in May of this year, namely that data from the prevalent screening round showed a substantially higher positive predictive value than that was observed in the first PATHFINDER study.

提醒一下，我們在今年 5 月公佈了 NHS Galleri 試驗中普遍篩檢輪次的積極初步結果，即普遍篩檢輪次的數據顯示陽性預測值比在第一個 PATHFINDER 研究中觀察到的要高得多。

Now to review important new findings from our SYMPLIFY study, I'll hand it off to Harpal.

現在，為了回顧我們 SYMPLIFY 研究的重要新發現，我將把發言權交給 Harpal。

Thanks, Josh, and good afternoon, everyone. Working with the University of Oxford, we recently shared positive long-term results for an extended follow-up of the SYMPLIFY study at the Early Detection of Cancer Conference, or EDCC, in October. As a reminder, we conducted the observational SYMPLIFY study in symptomatic participants in the UK to understand whether our technology could play a role helping clinicians guide investigation and accelerate time to diagnosis when patients present with concerning but non-specific symptoms. Examples of these symptoms could include unexplained weight loss, fatigue, persistent abdominal pain, and others.

謝謝你，喬希，大家下午好。我們與牛津大學合作，最近在 10 月舉行的癌症早期檢測會議 (EDCC) 上分享了 SYMPLIFY 研究的長期隨訪的積極結果。提醒一下，我們曾在英國對有症狀的參與者進行了觀察性 SYMPLIFY 研究，以了解我們的技術是否可以幫助臨床醫生指導調查，並在患者出現令人擔憂但非特異性症狀時加快診斷速度。這些症狀的例子包括不明原因的體重減輕、疲勞、持續性腹痛等。

The previous primary analysis from SYMPLIFY published in the Lancet Oncology in 2023, followed participants until diagnostic resolution or up to nine months and demonstrated Galleri's PPV in this population was approximately 75%. Patients determined to have a false positive Galleri result were followed for an additional 15 months in the National Cancer Registry for England and Wales.

SYMPLIFY 先前的主要分析發表於 2023 年的《柳葉刀腫瘤學》雜誌，該分析對參與者進行了隨訪，直至診斷明確或長達九個月，結果表明 Galleri 在該人群中的陽性預測值約為 75%。在英格蘭和威爾斯國家癌症登記處，對被確定為 Galleri 假陽性的患者進行了額外的 15 個月追蹤。

The updated analysis presented at EDCC includes the subsequent registry follow-up period for all 79 of the patients who were originally classified as false positives, and the data contained a number of important learnings. First, approximately one-third of the participants initially believed to be false positives were diagnosed with cancer during the full follow-up period. Second, of that group, a cancer signal of origin, or CSO, prediction from the Galleri test was correct in all but one patient.

在 EDCC 上提出的更新分析包括對最初被歸類為假陽性的 79 名患者的後續登記隨訪期，數據中包含許多重要的經驗教訓。首先，最初被認為是假陽性的參與者中，約有三分之一在整個追蹤期間被診斷出罹患癌症。其次，在該組中，除一名患者外，所有患者的 Galleri 測試結果均正確預測了癌症起源訊號 (CSO)。

And finally, with the reduction in false positives in SYMPLIFY from 79 to 51, the updated PPV for Galleri in this symptomatic population increased to 84.2%. These findings reinforce the importance of proactive follow-up after a positive MCED test result and the value of the Galleri test's accurate CSO capability.

最後，隨著 SYMPLIFY 的偽陽性率從 79 降至 51，Galleri 在此有症狀族群的更新陽性預測值 (PPV) 提高至 84.2%。這些發現強調了在 MCED 檢測結果呈陽性後進行積極跟進的重要性，以及 Galleri 檢測準確的 CSO 能力的價值。

Now to Aaron for a review of our financials.

現在請亞倫來審閱一下我們的財務狀況。

Thanks, Harpal, and good afternoon, everyone. I'm pleased to present our results for the third quarter.

謝謝哈帕爾，大家下午好。我很高興向大家介紹我們第三季的業績。

Revenue for the quarter was $36.2 million, up $7.5 million or 26% as compared to the third quarter of 2024. Total revenue for the quarter is composed of $32.8 million of screening revenue and $3.4 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of our clinical studies, pilot testing, research, and therapy development.

本季營收為 3,620 萬美元，比 2024 年第三季成長 750 萬美元，增幅達 26%。本季總收入由 3,280 萬美元的篩選收入和 340 萬美元的開發服務收入組成。開發服務收入包括我們為生物製藥和臨床客戶提供的服務，包括支援我們的臨床研究、試點測試、研究和治療開發。

We continue to see demand for our Galleri test and sold more than 45,000 tests in the third quarter. We have historically observed seasonal fluctuations over the course of the year, in particular, relatively high volume in the second and fourth quarters and lower in the first and third. And we would expect these seasonal trends to continue. Screening revenue of $32.8 million in the third quarter was up 29% as compared with the third quarter of 2024. US Galleri revenue was $32.6 million, up 28% compared to the third quarter last year.

我們繼續看到市場對 Galleri 檢測的需求，第三季售出了超過 45,000 份檢測。從歷史數據來看，我們觀察到一年中存在季節性波動，特別是第二季和第四季的交易量相對較高，而第一季和第三季的交易量較低。我們預計這些季節性趨勢將會持續。第三季篩檢收入為 3,280 萬美元，比 2024 年第三季成長了 29%。美國 Galleri 的營收為 3,260 萬美元，比去年第三季成長了 28%。

At the beginning of the year, we guided full-year 2025 US Galleri revenue growth between 20% to 30%. We are refining this growth guidance today to the middle of that range. Cost of screening revenue, exclusive of amortization of intangible assets as a percent of screening revenue decreased mainly due to lower variable costs of Galleri testing performed on our automated platform, partially offset by a decrease in ASP and higher sample reprocessing costs.

年初時，我們預計 2025 年美國 Galleri 全年營收成長將在 20% 至 30% 之間。今天，我們將成長預期調整至該區間的中間值。篩選收入成本（不包括無形資產攤銷）佔篩選收入的百分比下降，主要是由於在我們自動化平台上進行的 Galleri 測試的可變成本降低，但部分被 ASP 下降和樣品再處理成本增加所抵消。

Net loss for the quarter was $89 million, an improvement of 29% as compared to the third quarter of 2024. Gross loss for the third-quarter 2025 and 2024 were $13.7 million and $22.2 million, respectively. Non-GAAP adjusted gross profit for the third quarter of 2025 was $20 million, an increase of $8.2 million or 69% as compared with the third quarter of 2024.

本季淨虧損為 8,900 萬美元，比 2024 年第三季減少了 29%。2025 年第三季和 2024 年第三季的總虧損分別為 1,370 萬美元和 2,220 萬美元。2025 年第三季非 GAAP 調整後毛利為 2,000 萬美元，比 2024 年第三季增加了 820 萬美元，增幅達 69%。

In Q3, we achieved a non-GAAP adjusted gross margin of 55% compared to 41% in the third quarter of 2024. This change was largely driven by improvements in variable costs on our updated Galleri platform that launched last year and by an increase in sample volume for the quarter as we ran a onetime batch of research and development samples for clinical validation, resulting in reduced fixed cost per sample related to higher lab efficiency at higher volumes. We do not expect similar clinical validation sample volume in future quarters, but the higher number of samples processed demonstrates the benefits we expect to see in lab efficiency as the sample volume grows.

第三季度，我們實現了 55% 的非 GAAP 調整後毛利率，而 2024 年第三季為 41%。這項變更主要得益於我們去年推出的更新版 Galleri 平台的可變成本的改善，以及本季樣本量的增加，因為我們運行了一批用於臨床驗證的研發樣本，從而降低了每個樣本的固定成本，提高了實驗室效率，提高了樣本量。我們預計未來幾季不會出現類似的臨床驗證樣本量，但處理的樣本數量增加表明，隨著樣本量的增長，我們預期實驗室效率會提高。

We ended the quarter with cash and investment position of $547.1 million. Including net proceeds from the $325 million private placement in October, we have approximately $850 million of cash and investments. This does not include the recently agreed upon investment in GRAIL by Samsung, which is subject to closing conditions. In August, we drew down our cash burn guidance for the full year 2025 to be no more than $310 million from no more than $320 million.

本季末，我們的現金和投資部位為 5.471 億美元。加上 10 月私募配售的 3.25 億美元淨收益，我們擁有約 8.5 億美元的現金和投資。這還不包括三星最近同意對 GRAIL 進行的投資，該投資尚需滿足成交條件。8 月份，我們將 2025 年全年的現金消耗預期從不超過 3.2 億美元下調至不超過 3.1 億美元。

Today, we are updating our cash burn guidance further to no more than $290 million for the full-year of 2025, net of $13 million in placement fees from our recently completed financing. Expected full-year burn represents a significant decrease of approximately 50% compared to 2024 as we remain focused on cost management. We believe our cash runway extends into 2030, enabling us to achieve major planned clinical and regulatory milestones.

今天，我們將進一步更新 2025 年全年現金消耗預期，不超過 2.9 億美元，扣除我們最近完成的融資中 1,300 萬美元的配售費。預計全年消耗量將比 2024 年大幅減少約 50%，因為我們將繼續專注於成本管理。我們相信，我們的現金儲備可以維持到 2030 年，使我們能夠實現計劃中的主要臨床和監管里程碑。

I'll hand it back to Bob for concluding remarks.

我將把發言權交還給鮑勃，讓他做總結發言。

Thanks, Aaron. Our strategic priorities are seeking FDA approval of Galleri and pursuing broad reimbursement. We are advancing Galleri in the near and midterm towards key clinical and regulatory catalysts to achieve broad access while maintaining our disciplined cost management. As we move into 2026, our key milestones are the completion of our modular PMA submission to the FDA and full clinical utility results from our 140,000-participant NHS Galleri study, which we expect to read out midyear. This longitudinal data set will be reviewed by the NHS to determine Galleri's potential deployment within the UK population.

謝謝你，亞倫。我們的策略重點是尋求 FDA 對 Galleri 的批准並爭取廣泛的健保報銷。在近期和中期內，我們將推動 Galleri 的發展，以期在關鍵的臨床和監管方面取得突破，從而實現廣泛的市場准入，同時保持嚴格的成本控制。展望 2026 年，我們的主要里程碑是完成向 FDA 提交的模組化 PMA 申請，以及獲得 14 萬名參與者的 NHS Galleri 研究的完整臨床實用性結果，我們預計將在年中公佈結果。英國國家醫療服務體系 (NHS) 將審查這份縱向資料集，以確定 Galleri 在英國人口中的潛在部署。

Lastly, we look forward to welcoming many of you on site tomorrow at our centralized labs in Research Triangle Park, North Carolina. A live webcast of our Analyst Day will begin at 11:00 AM Eastern Time and will also be available at the Investor Relations section of our website.

最後，我們期待明天在位於北卡羅來納州研究三角園區的中央實驗室迎接各位的到來。我們的分析師日活動將於美國東部時間上午 11 點開始進行網路直播，也可在我們網站的投資者關係版塊觀看。

Let's now go to Q&A. Operator, please go ahead.

現在進入問答環節。操作員，請開始。

(Operator Instructions)

（操作說明）

Subbu Nambi, Guggenheim.

蘇布南比，古根漢美術館。

The FDA time line is moved to Q1 instead of first half of 2026. What changed?

FDA的審批時間表已從2026年上半年提前至2026年第一季。發生了什麼變化？

Yes, Subbu, thanks for the question. So I think the main thing is just as we move forward in time, we've gotten more certainty in the range of when we'd be able to deliver that. So we've been saying first half for a fair amount of time, and it looks like things are on track well enough where we're more confident to be able to put out for the first quarter. So it's really just kind of tightening the confidence intervals around the time frame.

是的，Subbu，謝謝你的提問。所以我認為最重要的是，隨著時間的推移，我們對能夠實現這一目標的時間範圍有了更大的確定性。所以我們已經說了相當長一段時間的上半場了，現在看來一切進展順利，我們更有信心完成第一節。所以其實只是縮小了時間範圍的信心區間。

Perfect. And you're currently running a promotion on your website offering $150 off of Galleri for patients getting tested from October to year-end. What incentivized you to offer this promotion?

完美的。你們網站目前正在進行促銷活動，從 10 月到年底，凡在 Galleri 接受檢測的患者均可享有 150 美元的折扣。是什麼促使您推出這項促銷活動？

How has the demand elasticity in response to this promotion been? And is this -- are you piloting a reduction to $800 moving forward? And could this impact ASPs moving forward?

此次促銷活動的需求彈性如何？也就是說，你們正在試行將價格降至 800 美元嗎？這是否會對未來的平均售價產生影響？

Yeah. Maybe a couple of comments, and I'll turn it over to Andy Partridge, our CCO. So we've done a fair amount of work looking at the price elasticity on the test. And this is kind of a reflection of some of that work. We do know that there's significant price elasticity and going into the end of the year is a good time to exercise some of that.

是的。我可能還會補充幾點，然後就交給我們的首席商務官安迪·帕特里奇吧。因此，我們已經做了相當多的工作來研究測試的價格彈性。這在某種程度上反映了我們所做的一些工作。我們知道價格彈性很大，而年底正是利用這種彈性的好時機。

But maybe to answer some of the other pieces, Andy, do you want to take that?

但或許為了回答其他一些問題，安迪，你想接受這個答案嗎？

Yeah. Thanks, Bob. So as you saw, we have reduced the price on the website. The growth that we've seen in Q3 year over year has been predominantly driven by the provider channel, where we've seen improvements in both breadth of prescribing, bringing new prescribers onto using Galleri and also depth of prescribing. So discounting has been a component of increasing that depth and breadth of prescribing.

是的。謝謝你，鮑伯。正如您所看到的，我們已經降低了網站上的價格。第三季年成長主要得益於供應商管道，我們在處方廣度（吸引更多新處方醫生使用 Galleri）和處方深度方面都看到了改善。因此，折扣一直是增加處方深度和廣度的一個組成部分。

Also the integrations we've done with companies like Quest and Athena have also driven a lot of that breadth and depth. And then finally, repeat testing, which price is also a component of that, has also driven that depth of prescribing as well. So we're very pleased with what we've seen in the market.

此外，我們與 Quest 和 Athena 等公司進行的整合也大大拓展了業務的廣度和深度。最後，重複檢測（價格也是其中的因素）也推動了處方深度的增加。所以我們對目前市場上的情況非常滿意。

Kyle Mikson, Canaccord.

Kyle Mikson，Canaccord。

Congrats on the progress. So you've obviously bolstered the balance sheet nicely. You should have over an additional $400 million by early '26 with the Samsung investment.

恭喜你取得進展。顯然，你們已經很好地改善了資產負債表。到 2026 年初，憑藉三星的投資，你應該會額外獲得超過 4 億美元的資金。

I was just curious how you plan to use the additional capital? And specifically, how does the commercial strategy change, especially in light of recent or upcoming competition? And I appreciate to hear Andy's thoughts on that as well.

我只是好奇您打算如何使用這筆額外的資金？具體而言，商業策略會如何變化，尤其是在近期或即將到來的競爭背景下？我也想聽聽安迪對此的看法。

Yeah. So I think you hit some of it. Obviously, it gives us a lot more flexibility on the balance sheet. With competition emerging, it does give us more flexibility in how we think about flexing our commercial investments. So we're looking at those things as well as any of the other areas that we need to really fortify as we continue to scale and expand our test footprint in the marketplace.

是的。所以我覺得你說的有些道理。顯然，這讓我們在資產負債表方面擁有更大的靈活性。隨著競爭的出現，我們在考慮如何調整商業投資方面有了更大的靈活性。因此，我們正在關注這些方面，以及隨著我們不斷擴大市場測試規模，我們需要真正加強的其他任何領域。

But I guess, Andy, do you want to also comment on that?

不過，安迪，你對此也想發表一下看法嗎？

Yeah. I think, Bob and I really covered it. I think the thing that I would emphasize is we feel like we've got a lot of momentum right now with customers for all of the reasons that I described, and definitely coming now off the back of the PATHFINDER 2 data that we presented at ESMO, there's a palpable momentum that we have in our business.

是的。我覺得，我和鮑伯已經把這件事討論清楚了。我想強調的是，由於我剛才描述的所有原因，我們感覺目前與客戶的合作勢頭強勁，而且，在我們於 ESMO 大會上展示了 PATHFINDER 2 數據之後，我們的業務發展勢頭非常明顯。

Got it. That's helpful, guys. And also, Hims & Hers has made an investment in the company recently. Consequently, there's been some speculation that means GRAIL is going to take a direct-to-consumer approach to Galleri at some point. So could you just comment on those plans or the potential to take that route over time in light of the increasing focus on longevity among consumers?

知道了。這很有幫助，夥計們。此外，Hims & Hers 最近也對該公司進行了投資。因此，有人猜測，這意味著 GRAIL 將在某個時候對 Galleri 採取直接面向消費者的銷售方式。那麼，鑑於消費者越來越關注壽命延長，您能否就這些計劃或未來採取這種路線的可能性發表一下看法？

Yeah. No, it's a good question. We're -- as we just reiterated our time line for our PMA, we're very committed to the PMA pathway. And so there's kind of no change in that. In fact, you saw a slight acceleration in the actual time frame.

是的。不，這是個好問題。正如我們剛才重申的 PMA 時間表一樣，我們非常致力於 PMA 途徑。所以這方面並沒有什麼改變。事實上，在實際時間範圍內，你會看到稍微加快的速度。

But beyond that, we do also recognize that the digital health channel is an important channel out there more broadly in this sector as well as many others. And so we want to make sure that we're able to utilize all the channels that are available to bring. We've talked from the very beginning about how do we get broad access for Galleri, and that will be one other element to enable broad access. But that also would not diminish our -- again, our push towards a PMA and broad access through that.

但除此之外，我們也意識到，數位健康管道在這個領域以及許多其他領域都是一個重要的管道。因此，我們希望確保能夠利用所有可用的管道進行傳播。從一開始我們就一直在討論如何讓 Galleri 獲得廣泛的關注，而這將是實現廣泛關注的另一個要素。但那也不會削弱我們——再次強調——推動 PMA 和透過 PMA 實現廣泛准入的努力。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

So I want to actually talk about NHS England a little bit more, and then I have a COGS-specific question. So starting on NHS England, looking back to May 2024, when the statement was issued saying that early results were not compelling enough to justify a large-scale pilot, were they referring to any clinical utility data from year one or to test level performance metrics such as PPV, sensitivity and/or specificity? Can you share a little bit more on what prompted that decision?

所以我想再多談談英國國民醫療服務體系（NHS England），然後我還有一個關於成本（COGS）的具體問題。那麼，從英國國家醫療服務體系（NHS England）開始，回顧 2024 年 5 月，當時發布聲明稱，早期結果不足以證明大規模試點的合理性，他們指的是第一年的任何臨床實用性數據，還是指 PPV、靈敏度和/或特異性等測試級別的性能？您能否詳細說說促使您做出這個決定的原因？

And then on the same topic, has anyone besides GRAIL and the NHS evaluation team seen the year one NHS Galleri data. I'm just curious if anyone else has seen it? And then if not, at what venue do you anticipate releasing that data more broadly, keeping in mind that you've said the FDA module submission is expected to be, I think, completed in Q1. So it would seem like that data would need to be released soon.

關於同一個主題，除了 GRAIL 和 NHS 評估團隊之外，還有誰看過 NHS Galleri 第一年的數據嗎？我只是好奇有沒有其他人也看過？那麼，如果不是這樣，您預計會在什麼場合更廣泛地發布這些數據？請記住，您曾說過，FDA 模組的提交預計將在第一季完成。因此，這些數據似乎需要盡快公佈。

Yeah. Harpal, do you want to take that one up?

是的。哈帕爾，你想接下這個任務嗎？

Sure. Thank you, Doug. So on NHS England's decision last year, important to reiterate that what they would have wanted to see in order to initiate a pilot at that stage was very exceptional data. And they looked at a few specific metrics, of which PPV was definitely one. To remind everyone, it isn't possible to look at the sort of broad utility measure of Stage 3 and 4 reduction with only one year of data. That has to come with three years of data. But PPV was certainly one.

當然。謝謝你，道格。因此，關於 NHS England 去年的決定，需要重申的是，他們當時希望看到的是非常出色的數據才能啟動試點計畫。他們考察了一些具體指標，其中付費觀看（PPV）肯定是其中之一。提醒大家，僅憑一年的數據，無法對第三階段和第四階段減排的廣泛效用指標進行評估。這需要三年的數據支持。但付費觀看肯定是其中之一。

And you'll have seen our announcement earlier this year that the PPV in that first round was substantially greater than we saw in our first PATHFINDER study, which to remind everyone was 43%. So it gives you a sense of some of the information that was seen at the time. But again, to reiterate what the NHS would have wanted to see was truly exceptional data in order to accelerate -- and the point is they were looking about an acceleration of an implementation rather than waiting until the final study results. And what they said at the time was, it wasn't exceptional enough to accelerate that implementation and so that they wanted to wait for the final study results.

你們可能已經看到我們今年早些時候發布的公告，第一輪的 PPV 比我們在第一項 PATHFINDER 研究中看到的要高得多，提醒大家一下，PATHFINDER 的 PPV 為 43%。所以它能讓你了解當時人們所掌握的一些資訊。但再次重申，英國國家醫療服務體系 (NHS) 希望看到的是真正卓越的數據，以便加快實施——關鍵是他們希望加快實施，而不是等到最終研究結果出來。他們當時表示，這還不夠特殊，不足以加快實施，所以想等待最終的研究結果。

In answer to your second question, no, only the NHS evaluation team have seen that data so far. To the third question, yes, it will be the data from the prevalent round only from the intervention arm will be part of our FDA PMA submission package in Q1 next year, but that does not mean it will be in the public domain at that point. There won't be any data in the public domain from NHS Galleri until we have the final study results.

關於你的第二個問題，答案是否定的，目前只有 NHS 評估團隊看過這些數據。對於第三個問題，是的，只有乾預組的最新數據將作為我們明年第一季向 FDA 提交 PMA 申請資料的一部分，但這並不意味著屆時這些數據就會公開。在最終研究結果出來之前，NHS Galleri 的任何數據都不會公開。

Yeah. And we're expecting that full readout in the midpart of 2026.

是的。我們預計將在 2026 年年中公佈完整數據。

Bradley Bowers, Mizuho.

Bradley Bowers，瑞穗銀行。

Just one on volumes and then maybe one a little high level. But just on volumes, pretty acceleration here outgrew some seasonality. Just wanted to hear what's kind of driving volumes here, what cohorts? And then how that -- how we should think about that into next year and if international will have a tangible contribution next year?

就一個關於音量的，然後可能還有一個稍微高一點的。但就銷售量而言，這裡的成長速度已經超過了季節性因素的影響。想了解目前推動交易量成長的主要因素是什麼，是哪些族群？那麼，我們該如何考慮明年的情況，以及國際合作明年是否會做出實質貢獻？

Yeah. Aaron, you maybe want to take the volume question and maybe pass this off to Andy as well.

是的。Aaron，或許你應該把音量問題轉交給 Andy 來處理。

Yeah. I mean I think Andy, I can tag team that. So yes, you're right. I think volumes were up 39% for the quarter year over year. Andy has kind of touched on already where we're seeing more provider pull-through and so on for the reasons that you stated.

是的。我的意思是，我覺得安迪，我可以跟你一起完成這件事。是的，你說得對。我認為本季銷量較去年同期成長了 39%。Andy 已經大致提到了，由於你所說的那些原因，我們看到越來越多的供應商開始積極參與等等。

As far as international goes, there's very minimal international volumes today. It's an area that we're focusing on. And as you see through the Samsung engagement and so on that we're being opportunistic there, and we're excited about what could be. It's probably a little too early right now to say what volumes will be next year. But we're getting, as Andy said earlier, momentum internationally and lots of momentum domestically.

就國際業務而言，目前的國際業務量非常少。這是我們正在重點關注的領域。正如你從與三星的合作等等方面所看到的，我們正在抓住機會，我們對未來可能發生的事情感到興奮。現在預測明年的銷量可能還為時過早。但正如安迪之前所說，我們在國際上獲得了發展勢頭，在國內也獲得了極大的發展勢頭。

So Andy, anything you want to add?

安迪，你還有什麼要補充的嗎？

Nothing else to add. I think we covered it.

沒有其他要補充的了。我覺得我們已經討論過了。

And then if I could just double-click on the SYMPLIFY study. I think that's actually an interesting data point that going back and following up patients who were previously identified as false positives. I mean, does this -- were these patients, I guess, that went under typical protocols? Why were these cancers, I guess, kind of missed in follow-up?

然後，如果我能雙擊 SYMPLIFY 研究就好了。我認為這是一個很有趣的數據點，那就是回溯並追蹤那些之前被認定為假陽性的患者。我的意思是，這些病人，我猜，是按照常規流程治療的嗎？我想，為什麼這些癌症在後續追蹤中被漏診了呢？

And then also, there's, I guess, some serious implications about the possibility to detect cancers even earlier than the current paradigm or what follow-up testing would be. So I just wanted to hear your thoughts on that.

此外，我認為，這也涉及到一些嚴重的問題，例如能否比目前的模式更早發現癌症，以及後續的檢測應該如何進行。所以我想聽聽你對此的看法。

Yeah. Harpal, why don't you go through that?

是的。哈帕爾，為什麼不去體驗一下呢？

Yeah. I mean, look, first of all, it is, as you say, a really interesting set of data, and it's relatively recent. So we're still examining some of the detailed information. I think one of the most significant points is that many of these patients are presenting with very non-specific symptoms. And these are the types of symptoms that could be indicative of cancer and often they are, but they could also be indicative of many other conditions.

是的。我的意思是，首先，正如你所說，這是一組非常有趣的數據，而且數據相對較新。所以我們仍在研究一些詳細資訊。我認為最重要的一點是，這些患者中許多人表現出的症狀非常不典型。這些症狀可能是癌症的徵兆，通常也確實是癌症的徵兆，但它們也可能是許多其他疾病的徵兆。

And so primary care physicians, when they see patients like this and they suspect cancer, will typically refer them to where they think that cancer is likely to be in the body. But given these non-specific symptoms, many of them could be several different sites. And so then what happens is a patient gets referred to a particular type of clinic and they get worked up in that clinic for that type of cancer. But if nothing is found at that point, they may not be worked up any further.

因此，初級保健醫生在遇到這樣的病人並懷疑其患有癌症時，通常會將他們轉診到他們認為癌症可能存在於體內的部位。但鑑於這些症狀不具特異性，其中許多症狀可能來自多個不同的部位。因此，接下來發生的情況是，病人會被轉診到特定類型的診所，並在該診所接受針對該類型癌症的檢查和治療。但如果到那時仍然沒有發現任何問題，他們可能不會再進行進一步的檢查。

And because this was an observational study, we didn't provide the CSO prediction to the clinician at the time. But what we've subsequently determined from this further follow-up is, had we done so, it would have provided a directional investigation in all but one of the patients, which we think is a really encouraging development in terms of that CSO prediction capability.

由於這是一項觀察性研究，我們當時沒有向臨床醫生提供 CSO 預測結果。但我們隨後透過進一步的追蹤發現，如果我們這樣做，除了其中一名患者外，其他所有患者都將得到方向性調查，我們認為這對於 CSO 預測能力來說是一個非常令人鼓舞的進展。

Yeah. And I would just add to Harpal's point, the value of the CSO because what we've also seen in centers that have adopted Galleri in the US is physician confidence growing in the value of that CSO. We've seen real-world publications from both Mayo and Dana-Farber where their PPVs have been in excess of 70%.

是的。我只想補充 Harpal 的觀點，CSO 的價值在於，我們在美國採用 Galleri 的中心也看到了醫生對 CSO 價值的信心不斷增強。我們已經看到梅奧診所和丹娜-法伯癌症研究所的實際出版物，他們的PPV（按次付費）都超過了70%。

So that physician confidence in the value of the CSO really means they really work that diagnostic workup to a final resolution. And what we've seen there, therefore, there is more cancers being diagnosed due to that guided diagnostic follow-up from the CSO.

因此，醫生對 CSO 價值的信心意味著他們確實會認真完成診斷工作，直到最終解決問題。因此，我們看到，由於 CSO 的指導性診斷隨訪，確診的癌症病例更多了。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

So I think it's an Aaron question. Cost of screening revenue, I think in dollar terms, it was down $3 million relative to Q2. That's kind of a mid-teens decline sequentially on a per test basis. I think it was down 28% on a per test basis year over year.

所以我覺得這是個關於亞倫的問題。篩檢收入成本，我認為以美元計算，與第二季相比下降了 300 萬美元。從每次測試來看，這有點像是十幾歲中期開始的逐次下降。我認為以每次檢測計算，比去年同期下降了 28%。

So I just want to make sure, at least I'm in the right ballpark in doing the math. And if so, that's pretty impressive and remarkable. Can you just share how you're getting there and the durability and the trajectory from here?

所以我只是想確認一下，至少我的計算結果大致正確。如果真是這樣，那真是令人印象深刻，非常了不起。能否分享一下你們是如何實現目標的，以及目前的進展和未來發展軌跡？

Sorry, jump up.

抱歉，跳起來。

Yeah, I was say Aaron talked a little bit about that in the prepared remarks. But yeah, Aaron, why don't you go into a little more detail on that?

是的，我想說的是，亞倫在準備好的演講稿中稍微談到了這一點。不過，亞倫，你為什麼不詳細說說呢？

Yeah. Doug, I think it's really an example of what we've been saying for a year now about the platform that we've built for high throughput, the capacity that we have to run 1 million samples a year and just what higher volumes will show from a fixed cost leverage perspective. Comparing year over year, you've also got the variable cost impact that we've been talking about.

是的。道格，我認為這恰恰印證了我們一年來一直在強調的，我們建構了一個高通量平台，每年可以處理 100 萬個樣本，而更高的產量將從固定成本槓桿的角度展現出來。與往年相比，還有我們一直在討論的變動成本影響。

We've kind of talked about that as a four to five times more samples per flow cell compared to the older version. So it's really a demonstration of what more volume will do to our fixed cost leverage and why we're really focused on driving more volume, getting more access out there because we've got the infrastructure to handle it and the margins are there for the day.

我們之前討論過，與舊版本相比，每個流通池的樣本數量增加了四到五倍。所以這真正體現了銷售量增加對我們的固定成本槓桿作用，以及為什麼我們如此專注於提高銷售量、擴大市場准入，因為我們有基礎設施來應對，而且利潤空間也足夠大。

And there are no further questions at this time. I will now turn the call back to GRAIL for closing remarks.

目前沒有其他問題了。現在我將把電話轉回給 GRAIL，請他作總結發言。

So thank you, everyone, for joining today's call.

謝謝大家參加今天的電話會議。

Ladies and gentlemen, this concludes the call, and you may now disconnect.

女士們、先生們，通話到此結束，您可以掛斷電話了。