Grail Inc (GRAL) 2025 Q1 法說會逐字稿

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（技術難度）

-- performance of Galleri. As a reminder, Galleri demonstrated specificity of 99.5% and a CSO accuracy of 88% in Pathfinder. There were no serious safety concerns in the NHS Galleri prevalent screening round. As Bob mentioned, the top line results from the prevalent screening round of the NHS Galleri trial are very encouraging.

——Galleri 的表演。提醒一下，Galleri 在 Pathfinder 中展示了 99.5% 的特異性和 88% 的 CSO 準確率。NHS Galleri 流行篩檢輪調中沒有發現嚴重的安全問題。正如鮑伯所提到的，NHS Galleri 試驗的普遍篩檢輪調的最終結果非常令人鼓舞。

Results of all the three years of the trial are expected in mid 2026. These longitudinal results will be the first clinical utility results of their kind in the MCED field. The NHS Galleri trial was designed as three annual blood draws plus 12 months of follow-up in order to evaluate Galleri's ability to diagnose cancer at an earlier stage relative to standard of care. Cancer screening trials designed to show clinical utility are commonly conducted over three or more years using an annual screening interval.

預計三年試驗的結果將於 2026 年中期公佈。這些縱向結果將是 MCED 領域中首個此類臨床實用結果。NHS Galleri 試驗設計為每年抽血三次加上 12 個月的隨訪，以評估 Galleri 相對於標準治療在早期診斷癌症的能力。旨在展示臨床實用性的癌症篩檢試驗通常以年度篩檢間隔進行，為期三年或更長時間。

Because if screening is only conducted once, results can be influenced by the fact that the first screening round detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed. This and other factors are likely to cause final results of the three-year trial to differ from a review of the first round results. NHS Galleri is the largest and only randomized control trial of any MCED test, and the results thus far demonstrate strong Galleri performance.

因為如果只進行一次篩檢，結果可能會受到第一輪篩檢發現許多尚未確診的晚期無症狀癌症的影響。這一因素和其他因素可能會導致三年試驗的最終結果與第一輪結果的審查結果不同。NHS Galleri 是所有 MCED 測試中規模最大且唯一的隨機對照試驗，迄今為止的結果證明了 Galleri 的強大性能。

Together with England's NHS, we expect to publish detailed data from the ongoing NHS Galleri trial, including the primary endpoint of an absolute reduction in the number of stage three and four cancer diagnoses as well as a number of test performance secondary endpoints, including episode sensitivity in mid 2026.

我們預計將與英國 NHS 合作，在 2026 年中期發布正在進行的 NHS Galleri 試驗的詳細數據，包括三期和四期癌症診斷數量絕對減少的主要終點，以及一些測試性能次要終點，包括發作敏感性。

And with that, I'll now hand over to Josh.

現在我將把時間交給喬希 (Josh)。

At GRAIL, we have implemented one of the largest clinical evidence programs in the MCED space, with more than 385,000 participants overall.

在 GRAIL，我們實施了 MCED 領域最大的臨床證據項目之一，總共有超過 385,000 名參與者。

More than 21,000 participants were included in the studies to support the development and launch of Galleri, and over 170,000 individuals are included in our registrational studies which support our PMA submission to the FDA.

超過 21,000 名參與者參與了支持 Galleri 開發和發布的研究，超過 170,000 名個人參與了支持我們向 FDA 提交 PMA 的註冊研究。

Now, let's be clear, Galleri is working in the real world. We are detecting clinically meaningful cancers and early-stage cancers in asymptomatic adults. Our signal detection rate in commercial use is very much in line with what we expected based on our prior clinical studies. The majority of the early-stage cancers Galleri has found are in cancer types where a recommended screening test does not even exist, thereby allowing patients an opportunity to access more effective and even curative treatments.

現在，讓我們明確一點，Galleri 是在現實世界中工作的。我們正在檢測無症狀成人中的具有臨床意義的癌症和早期癌症。我們在商業用途的訊號檢測率與我們根據先前的臨床研究所預期的非常一致。加勒里發現的早期癌症大多屬於建議的篩檢測試尚不存在的癌症類型，讓患者有機會獲得更有效甚至是治癒性的治療。

Now we've described over time the key performance metrics, features and capabilities for multi-cancer early detection tests, which importantly are quite different from those for single cancer screenings. Positive predictive value or PPV is a key metric which discerns among positive test results how many are true positives.

現在我們已經描述了多種癌症早期檢測測試的關鍵表現指標、特徵和能力，重要的是它們與單一癌症篩檢的指標、特徵和能力有很大不同。陽性預測值或 PPV 是一個關鍵指標，它可以辨別陽性測試結果中有多少是真正的陽性。

Specificity, critically important, defines the false positive rate. A very low false positive rate helps reduce unnecessary workups and their associated costs and contributes to driving a high positive predictive value. Our demonstrated specificity at 99.5% equates to a false positive rate of 0.5%. So just to remind you, a 1% reduction in specificity to 98.5%, that is a 0.5% false positive rate, would then become a 1.5% false positive rate three times higher.

特異性至關重要，它決定了假陽性率。非常低的假陽性率有助於減少不必要的檢查及其相關費用，並有助於提高陽性預測值。我們證明的特異性為 99.5%，相當於假陽性率為 0.5%。所以提醒一下，特異性降低 1% 至 98.5%，即假陽性率為 0.5%，那麼假陽性率就會變成 1.5%，高出三倍。

So applying this to a real-world population of a million people tested, instead of there being only 5,000 false positives, there would now be 15,000. Such a reduced specificity would be expected also to result in a positive predictive value, about half of what we see at a specificity of 99.5% holding all other metrics constant.

因此，將其應用於現實世界中接受測試的一百萬人，結果將不再只有 5,000 個假陽性，而是有 15,000 個。預計這種降低的特異性也會導致陽性預測值，在所有其他指標保持不變的情況下，該值約為 99.5% 特異性的一半。

Finally, one of the most important features of a multi-cancer early detection test is the ability to localize that cancer signal. In multi-cancer early detection, CSO capability or a cancer signal of origin prediction, is the key to guiding physicians to an appropriate and efficient workup to diagnosis. We consistently hear from physicians in the field that this is a critical component of any multi-cancer screening test.

最後，多癌症早期檢測測試最重要的特徵之一是定位癌症訊號的能力。在多重癌症早期檢測中，CSO 能力或癌症起源訊號預測是指導醫生進行適當和有效的診斷的關鍵。我們經常聽到該領域的醫生說，這是任何多癌症篩檢測試的關鍵組成部分。

Even an FDA advisory committee on multi-cancer detection in November '23 similarly emphasized the importance of a cancer signal of origin feature in any multi-cancer detection test.

甚至 1923 年 11 月 FDA 多癌症檢測諮詢委員會也同樣強調了在任何多癌症檢測測試中癌症起源訊號特徵的重要性。

Our teams have continued to present evidence demonstrating Galleri's performance at renowned medical conferences. In April, at the AACR meeting, we shared a real world data set on Galleri's test performance and implementation in over 100,000 individuals. Galleri indeed identified cancers across this large intended use population, including early-stage cancers, and cancers without recommended screening.

我們的團隊不斷在知名的醫學會議上提供證據，證明 Galleri 的表現。今年 4 月，在 AACR 會議上，我們分享了 Galleri 在超過 10 萬名個人中測試表現和實施的真實世界數據集。加勒里確實在這個龐大的預期使用族群中發現了癌症，包括早期癌症和未經建議篩檢的癌症。

Generally, the test performance in this real-world setting remained consistent with what we've consistently observed in our prior clinical studies. Among other data we also presented at AACR in analysis highlighting the importance of annual screening with an MCED test, model data of post-test probabilities of cancers for individuals receiving MCED tests showed that individuals receiving a negative MCED test, and they have a reduced risk of late-stage cancer diagnosis for one year after the blood draw. And then this risk increases as the screening interval extends beyond one year. This study really supports the need for annual testing.

總體而言，在這種現實環境中的測試表現與我們在先前的臨床研究中觀察到的情況保持一致。我們在 AACR 上展示的其他分析數據也強調了每年 MCED 測試篩檢的重要性，接受 MCED 測試的個體的癌症後驗機率模型數據顯示，接受 MCED 測試陰性的個體在抽血後一年內被診斷為晚期癌症的風險降低。隨著篩檢間隔超過一年，這種風險就會增加。這項研究確實支持每年進行測試的必要性。

Finally, I'd like to highlight that US health systems are now publishing their own experiences with Galleri performance and implementation. A paper authored by the Mayo Clinic and published recently in March in the Journal of Primary Care and Community Health showed that Galleri effectively detected cancers in an asymptomatic population within their healthcare system and had a 73% positive predictive value. In other words, 73% of those with a positive Galleri test yielded a confirmed new cancer diagnosis.

最後，我想強調的是，美國衛生系統目前正在發布他們自己與 Galleri 合作的性能和實施經驗。由梅奧診所撰寫並於 3 月最近在《初級保健和社區健康雜誌》上發表的一篇論文表明，Galleri 能夠有效地檢測出其醫療系統內無症狀人群中的癌症，陽性預測值為 73%。換句話說，73% 的 Galleri 檢測呈陽性的患者被確診為新的癌症。

Now the sample in this Mayo Clinic analysis was relatively small and had some different patient demographics compared to our prior trials. Importantly, this paper included the Mayo Clinic's standardized approach to pursue a diagnostic workup following a positive cancer signal and our signal of origin prediction.

現在，梅奧診所的分析樣本相對較小，與我們先前的試驗相比，患者的人口統計數據有一些不同。重要的是，本文包含了梅奧診所的標準化方法，用於在出現陽性癌症信號後進行診斷檢查以及我們的起源信號預測。

The outline steps are informed by a multidisciplinary expert counsel convened by the Mayo Clinic. Then they reviewed our cancel signal of origin prediction and other data from our first Pathfinder trial. These recommendations continue to be updated, and they've really served as a centralized resource for the Mayo Clinic physicians.

此概要步驟由梅奧診所召集的多學科專家顧問提供。然後他們審查了我們取消起源訊號預測以及我們第一次探路者試驗的其他數據。這些建議不斷更新，而且它們確實成為了梅奧診所醫生的集中資源。

Now additional health systems and clinicians are beginning to publish their experience with Galleri. Upcoming ASCO 2025 presentations of note include the implementation and evaluation of multi-cancer early detection testing at the Dana-Farber Cancer Institute, a retrospective analysis of clinical outcomes and diagnostic pathways. And an independent analysis by Alabama Cancer Care, titled A Clinical Review of a Novel Blood Test Use in Rural Alabama for Multi-cancer Detection Analyzing methylation patterns of Cell-free DNA and Future strategies.

現在，其他醫療系統和臨床醫生也開始發布他們與 Galleri 合作的經驗。即將舉行的 ASCO 2025 值得關注的演講包括丹娜—法伯癌症研究所的多癌症早期檢測的實施和評估，以及對臨床結果和診斷途徑的回顧性分析。阿拉巴馬癌症護理中心進行了一項獨立分析，題為《阿拉巴馬州農村地區用於多種癌症檢測的新型血液檢測的臨床評論》，分析了遊離 DNA 的甲基化模式和未來策略。

Now looking forward, we anticipate performance data from the first 25,000 participants in our other registrational study, Pathfinder 2, later this year. We also plan to conduct a bridging study between the version of Galleri used in our registrational trials, NHS Galleri and Pathfinder 2, to the updated version that we plan to submit to the FDA for pre-market approval. We plan to submit data from the prevalent screening round of the NHS Galleri trial. The first 25,000 participants in the Pathfinder II study and the bridging study as part of our pre-market approval application in the first half of '26.

展望未來，我們預計今年稍後將獲得另一項註冊研究 Pathfinder 2 的前 25,000 名參與者的表現數據。我們還計劃對我們的註冊試驗中使用的 Galleri 版本 NHS Galleri 和 Pathfinder 2 與我們計劃提交給 FDA 進行上市前批准的更新版本進行橋接研究。我們計劃提交 NHS Galleri 試驗流行篩檢輪調的數據。作為我們 26 年上半年上市前批准申請的一部分，Pathfinder II 研究和橋接研究中的前 25,000 名參與者。

I'll now hand it over to Aaron for a review of our financials.

我現在將其交給 Aaron 來審查我們的財務狀況。

Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the first quarter. First quarter results were strong, with revenue of $31.8 million up $5.1 million or 19% as compared to the first quarter of 2024.

謝謝，喬希，大家下午好。我很高興地公佈我們第一季的業績。第一季業績強勁，營收為 3,180 萬美元，與 2024 年第一季相比成長 510 萬美元，增幅為 19%。

Total revenue for the quarter is comprised of $29.1 million of screening revenue and $2.7 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development.

本季總收入包括 2,910 萬美元的篩選收入和 270 萬美元的開發服務收入。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，包括臨床研究支援、中試測試、研究和治療開發。

We see continued demand for our Galleri test, and sold more than 37,000 tests in the first quarter, a period we have observed historically to be softer relative to the fourth quarter. Repeat test volumes have moved higher over time, including in early 2025. More than 20% of Galleri volume today is repeat testing. Screening revenue of $29.1 million in the first quarter was up 24% as compared with the first quarter of 2024.

我們看到市場對 Galleri 測試的需求持續成長，第一季銷售了超過 37,000 個測試，而從歷史上看，這段期間的銷售情況相對於第四季而言較為疲軟。隨著時間的推移，重複測試量不斷增加，包括 2025 年初。如今，Galleri 的銷量有 20% 以上是重複測試。第一季的放映收入為 2,910 萬美元，與 2024 年第一季相比成長了 24%。

US Galleri revenue was $28.7 million up 22% compared to the first quarter full year guidance we shared in January of US Galleri revenue growth of 20% to 30%. We do not expect major impacts from tariffs on our current business as our laboratory is located in the US and a significant majority of our suppliers are located in and manufactured in the US.

美國畫廊的收入為 2870 萬美元，與我們 1 月分享的第一季全年預期（美國畫廊的收入增長 20% 至 30%）相比增長了 22%。我們預計關稅不會對我們目前的業務產生重大影響，因為我們的實驗室位於美國，而且我們的絕大多數供應商都位於美國並在美國製造。

Net loss for the quarter was $106.2 million an improvement of 51% as compared to the first quarter of 2024. And included amortization of intangible assets of $34.6 million and stock-based compensation of $16.2 million.

本季淨虧損為 1.062 億美元，與 2024 年第一季相比改善了 51%。其中包括 3,460 萬美元的無形資產攤提和 1,620 萬美元的股票薪酬。

Non-GAAP adjusted gross profit for the first quarter of 2025 was $14.3 million, an increase of $2.3 million or 19% as compared to the first quarter of 2024. We ended the quarter with a cash position of $677.9 million. In January, we guided that we expect cash burn for the full-year 2025 to be no more than $320 million. This represents a decrease of more than 40% compared to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones.

2025 年第一季非公認會計準則調整後毛利為 1,430 萬美元，較 2024 年第一季增加 230 萬美元，增幅為 19%。本季末我們的現金狀況為 6.779 億美元。今年 1 月，我們預計 2025 年全年現金消耗將不超過 3.2 億美元。與 2024 年相比，這一數字下降了 40% 以上。我們的現金流延伸至 2028 年，使我們能夠實現計劃中的主要臨床和監管里程碑。

Thank you, Aaron. To close, we remain encouraged by the demand we are seeing today while we advance towards major milestones, seeking FDA approval of Galleri and pursuing broad reimbursement.

謝謝你，亞倫。最後，我們仍然對今天看到的需求感到鼓舞，同時我們正在朝著重要的里程碑邁進，尋求 FDA 對 Galleri 的批准並尋求廣泛的報銷。

We are very pleased to have taken additional strides in early 2025, including executing on the transition to the enhanced, more scalable version of Galleri, achieving Tricare coverage, and enabling easier access to Galleri ordering through Quest Diagnostics and Athena Health.

我們非常高興在 2025 年初取得了更多進展，包括執行向增強型、更具可擴展性的 Galleri 版本的過渡、實現 Tricare 覆蓋，以及透過 Quest Diagnostics 和 Athena Health 更輕鬆地訪問 Galleri 訂購。

Looking ahead, we expect to share interim data from Pathfinder to study in late 2025, that the data set will include the first 25,000 of the 35,000 participants enrolled. In 2026, key milestones include the completion of our modular PMA submission to the FDA in the first half and final results from our 140,000 participant NHS Galleri study.

展望未來，我們預計將在 2025 年底分享 Pathfinder 的中期數據以供研究，該數據集將包括 35,000 名參與者中的前 25,000 名。2026 年，關鍵里程碑包括上半年完成向 FDA 提交模組化 PMA 以及 140,000 名參與者的 NHS Galleri 研究的最終結果。

But that will turn the call over to Q&A operator, please go ahead.

但這會將電話轉給問答接線員，請繼續。

(Operator Instructions)

（操作員指示）

Subbu Nambi, Guggenheim Partners.

蘇布南比 (Subbu Nambi)，古根漢合夥人事務所。

Hey, guys. Thank you for taking my question. My first question is back in December, the new version of Galleri was starting to be offered with expected short term variable cost improvement. Can you quantify what those were in the quarter and what should be --

嘿，大家好。感謝您回答我的問題。我的第一個問題是，早在 12 月，新版 Galleri 就開始推出，預計短期內變動成本會有所改善。您能否量化本季的這些內容以及應該--

Yeah, so as you said, we did launch at the end of last year. This year, the first quarter we're on that new version, and we'd expect to see margins continue to improve over the rest of the year as we increase scale and just work through the launch transition that we're going through this quarter. As you said, you'll see those variable COGS and improvements come over time as we move everything over to that, the new version completely.

是的，正如你所說，我們確實是在去年年底推出的。今年第一季我們推出了新版本，隨著規模的擴大以及本季正在經歷的發布過渡，我們預計利潤率將在今年剩餘時間內繼續提高。正如您所說，隨著我們將所有內容完全轉移到新版本，您會看到這些可變的 COGS 和改進會隨著時間的推移而出現。

Got it. And then, when setting guidance, you said you considered Quest and said legislation and Tricare approval. How have those played out to your expectations in 1Q and then is there any upside from here more than what you expected?

知道了。然後，在製定指導時，您說您考慮了 Quest 並提到了立法和 Tricare 批准。這些在第一季的表現與您的預期如何？接下來是否有超出您預期的優勢？

Yeah, so, early days on both Quests as well as Tricare, so we are seeing improved ordering from Quest providers that are going through the Quest portal. So that's very encouraging, but again, early days on that and Tricare, we're working through the contracting process. So we're we're in coverage with Tricare, but working through the coverage process process with the various contractors there. So more to come on that later in the year.

是的，Quest 和 Tricare 都處於早期階段，因此我們看到透過 Quest 入口網站的 Quest 提供者的訂單有所改善。這是非常令人鼓舞的，但是，在這個專案和 Tricare 的早期階段，我們正在完成簽約流程。因此，我們在 Tricare 的承保範圍內，但正在與那裡的各個承包商合作完成承保流程。今年稍後我們會發布更多相關資訊。

Got it. Thank you, guys.

知道了。謝謝你們。

Tejas Savant, Morgan Stanley.

摩根士丹利的 Tejas Savant。

So maybe, just one on the cash born in the quarter, I guess, can you help us just think about the burn trajectory over the course of the next, between now and your end, how you're tracking towards that sort of $320 million or less than born target that you guys had?

因此，也許，就本季產生的現金而言，我想，您能否幫助我們思考一下下一季（從現在到結束）的現金消耗軌跡，您如何朝著 3.2 億美元或低於您設定的產生目標的方向前進？

And then second, on sort of a related note, you we've got a couple of, other MCED launches coming up here, including one from, an established brand in single cancer screening. So how are you thinking about your OpEx levels, which you've done a good job sort of controlling, so as to keep the burn down? You need to sort of, think about re-accelerating it a little bit as as some of those other offerings.

其次，與此相關的是，我們即將推出其他幾款 MCED 產品，其中一款來自單一癌症篩檢領域的知名品牌。那麼您如何看待您的營運支出水準？您已經很好地控制了營運支出，從而降低了成本？您需要考慮稍微加速一下它，就像其他一些產品一樣。

Yeah, on the cash burn, so I think we burn just under $90 million first quarters, the period that we pay out our annual bonus from the prior year, which is something of course not going to repeat in the future quarters. And also as we talked about margins, just the last question, as we grow more and as margins improve, the cash burden will be in the $320 million range that we gave.

是的，關於現金消耗，我認為我們在第一季消耗了將近 9000 萬美元，這段時間我們支付了去年的年度獎金，當然這種情況在未來幾個季度不會再發生。而且正如我們討論的利潤率，也就是最後一個問題，隨著我們的成長和利潤率的提高，現金負擔將在我們給出的 3.2 億美元的範圍內。

OpEx and competitors, so it's good actually to see, others investing in multi cancer early detection. As we, I think we've noted on this call where we've been doing all the heavy lifting in terms of really educating the field of developing the market. We've made unprecedented investments though to set a very high bar for the field and demonstrated a really strong specifications based on that. And so we'll have to take a look and see, from the announcements, what actually transpires in terms of actual competitive approaches to see if that's going to have any OpEx impacts on us. So right now, I would say it's not clear that we have OpEx impacts from those launches, but something we'll monitor over the next couple quarters.

OpEx 和競爭對手，因此很高興看到其他人投資於多種癌症早期檢測。正如我們，我想我們已經在這次電話會議上指出，我們在真正教育開發市場領域方面做了所有繁重的工作。我們進行了前所未有的投資，為該領域設定了非常高的標準，並在此基礎上展示了非常強大的規格。因此，我們必須從公告中觀察實際競爭方式的實際情況，看看這是否會對我們的營運支出產生影響。因此，現在我想說的是，目前尚不清楚這些產品的發布是否會對營運支出產生影響，但我們會在接下來的幾季內進行監控。

Got it, fair enough. And then a couple of quick cleanups on the data side, guys. So the intervention arm, from the NHS Galleri, that data that you just shared, how should we be thinking about the read across from that your, next year's final NHS Galleri readout, like, particularly in terms of that higher PPV you highlighted? And can you put a finer point on, when in the second half of the year we can expect Pathfinder 2 data?

明白了，夠公平。然後夥計們，對數據方面進行一些快速清理。那麼，對於您剛剛分享的 NHS Galleri 幹預部門的數據，我們應該如何看待您明年最終的 NHS Galleri 讀數，特別是您強調的更高的 PPV 方面？您能否更詳細地說明一下，下半年我們什麼時候可以獲得探路者 2 號的資料？

Yeah, so on the second question, really looking to mid mid next year to have the readout on the full three-year study. We also have Harpal on the call today, so Harpal may be answering the first part of that question.

是的，關於第二個問題，我們確實希望明年中期能獲得完整的三年研究結果。我們今天也與 Harpal 進行了電話會議，因此 Harpal 可能會回答該問題的第一部分。

Yeah, sure, thank you for the question. So look, it's important just to reiterate that the results we've shared today are from the first screening round only. And as we've tried to describe, it's really important that the first round of a screening program, what you typically see is that you are finding a lot of prevalent cancers in the population that have not yet been diagnosed.

是的，當然，謝謝你的提問。所以，需要重申的是，我們今天分享的結果只來自第一輪篩選。正如我們試圖描述的，在篩檢計畫的第一輪中，你通常會發現人群中有很多尚未被診斷出來的流行癌症，這一點非常重要。

They are asymptomatic, but they can often be very late stage. And so as we go through to the second and third rounds, and those prevalent cancers in the population have already been diagnosed, we would expect to see some differences in the second and third round as indeed has other screening programs in the past. But we're not in a position today to be able to predict what those results will be, but we will have those results in mid '26.

它們沒有症狀，但通常已處於晚期。因此，當我們進行到第二輪和第三輪時，人群中流行的癌症已經被診斷出來，我們預計會在第二輪和第三輪中看到一些差異，就像過去的其他篩檢項目一樣。但我們今天還無法預測這些結果會是什麼，但我們將在 26 年中期得到這些結果。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Hey, good afternoon, everybody. Thank you for taking my questions. I want to talk about two things, the BMJ publication, and then I want to talk about your cash management strategy, which, is obviously top of mind for a lot of us.

嘿，大家下午好。感謝您回答我的問題。我想談兩件事，BMJ 出版物，然後我想談談您的現金管理策略，這顯然是我們許多人最關心的問題。

So starting on the BMJ publication. As you talked about in your prepared remarks, you demonstrated that annual MCED screening shows a higher projected impact on stage shift and mortality reduction relative to biennial testing. So keeping that in mind and then also the fact that you've indicated that based on draft MCED legislation that you would assume that ASPs would land in the 500 to 550 level, my questions are, do you believe that the ASP would be unaffected by testing interval, meaning if there's more frequent testing, does the ASP need to come down?

從 BMJ 出版品開始。正如您在準備好的演講中談到的，您證明了年度 MCED 篩檢相對於兩年一次的檢測，對分期轉變和死亡率降低具有更高的預期影響。因此，考慮到這一點，再加上您指出根據 MCED 立法草案，您會假設 ASP 將落在 500 到 550 的水平，我的問題是，您是否認為 ASP 不會受到測試間隔的影響，這意味著如果測試更頻繁，ASP 是否需要下降？

And then the second part of the question is, when you think about the cost to the system, if there was broad adoption of Galleri at that pricing level, how -- and then you think about by extension how much it would cost to find a single cancer. If we think about the cost for cancer detected, including subsequent workups and even a small number of false positives, would there be any concern in that scenario about the health economics, especially again for an annual test?

然後問題的第二部分是，當你考慮系統成本時，如果 Galleri 在該定價水平上被廣泛採用，那麼——然後你再考慮一下發現一種癌症需要花費多少錢。如果我們考慮檢測癌症的成本，包括後續檢查，甚至少數假陽性，那麼在這種情況下是否會對健康經濟學產生任何擔憂，尤其是對於年度檢測而言？

Josh, you want to take that one?

喬希，你想拿那個嗎？

Sure. So I think as you noted, we have a lot of data to suggest that based on cancer biology, Galleri should be administered on an annual basis, if we want to find early-stage asymptomatic cancer based on the rates with which cancers are progressing, given everything we know, on the biology of circulating DNA now.

當然。因此，我認為正如您所說，我們有大量數據表明，根據癌症生物學，如果我們想根據癌症進展的速度找到早期無症狀癌症，並考慮到我們目前對循環 DNA 生物學的了解，那麼應該每年進行 Galleri 治療。

So we think that's the right way to go, and all of our pricing strategies and everything we've projected about ASP are based on annual testing. So it's really too early to speculate on what would happen if we tested more frequently than that. From the health economic perspective, Doug, it's a great question. We know that with annual testing, even if populations scale, at the prices that are in the market today, let alone the lower ASPs that you're commenting on, this is a highly cost-effective intervention.

因此我們認為這是正確的做法，我們所有的定價策略以及有關 ASP 的所有預測都是基於年度測試。因此，現在推測如果我們更頻繁地進行測試會發生什麼還為時過早。道格，從健康經濟角度來看，這是一個很好的問題。我們知道，透過每年進行檢測，即使人群規模擴大，以目前市場的價格，更不用說您所評論的較低的平均售價，這是一種極具成本效益的干預措施。

And compared to what we're spending today to diagnose a cancer, given everything that's going on with the false positive rates of current single cancer screening, that the cost to diagnose a cancer with an MCED added to standard of care screening comes down substantially. And the numbers needed to screen are much lower than what we've seen traditionally with some of the single cancer screening tests. So even today, the health economic data are very compelling from an efficiency and cost-effectiveness perspective to payers by screening the population for any disease, but it's high value investment.

與我們今天診斷癌症所花費的費用相比，考慮到目前單一癌症篩檢的假陽性率，在標準護理篩檢的基礎上增加 MCED 來診斷癌症的成本大幅下降。並且需要篩檢的人數比我們傳統上看到的某些單一癌症篩檢測試的人數要低得多。因此，即使在今天，從效率和成本效益的角度來看，透過篩選人群是否患有任何疾病，健康經濟數據對付款人來說仍然非常有吸引力，但這是一項高價值的投資。

Okay, thank you for that. Good food for thought. So the second topic is on cash management. And just keeping in mind your stock, at least last I checked is up, about 140% year-to-date. There are obviously questions about your ability to fund operations through the period where you would plausibly get FDA approval and CMS reimbursement, and again, acknowledging you guys are doing a good job moving towards, trying to extend the runway as long as possible.

好的，謝謝你。值得深思。第二個主題是現金管理。請記住，至少我上次檢查時，你的股票今年迄今上漲了約 140%。顯然，人們對您在可能獲得 FDA 批准和 CMS 報銷期間為運營提供資金的能力存在疑問，並且再次承認您在努力盡可能延長跑道方面做得很好。

There are still concerns you can get there, especially given where we are with the MCED bill and, the path to FDA reimbursement and the approval and CMS reimbursement. So in a best case, recognizing those developments are several years away and also recognizing the NHS Galleri readout, which is pretty critical, doesn't read out until next year. And at that point, your cash position's going to be below half of what it is today, things start to get a little bit tight.

您仍會遇到一些擔憂，特別是考慮到我們目前面臨的 MCED 法案以及 FDA 報銷途徑、批准和 CMS 報銷問題。因此，在最好的情況下，認識到這些發展還需要幾年的時間，並且認識到非常關鍵的 NHS Galleri 讀數要到明年才能讀出來。到那時，你的現金狀況將會低於現在的一半，情況開始變得有點緊張。

So what was the calculus given all of these facts at the board level behind not raising money to de-risk the outlook? It seems like that would have been allow you to maybe play offense a little more aggressively, and to make the NH NHS read out like next year less binary. So simply put, what's the thinking here? What's the rationale to not take some steps? What are we missing?

那麼，考慮到所有這些事實，董事會層級不籌集資金來降低前景風險的背後原因是什麼？看起來，這可能會讓你更積極地進攻，並使 NH NHS 明年的讀數不那麼二元化。那麼簡單地說，這裡的想法是什麼？不採取某些措施的理由是什麼？我們缺什麼？

Doug, it's a good question. It's something we've obviously thought about. As we've said in, previous discussions, we think that getting through some of these milestones derisks the business and creates value for us. And so, in the calculus, we're looking at, getting through some of these major milestones and knowing that we have the cash runway to get through those was kind of the deciding factor towards waiting until things play out a little bit.

道格，這是個好問題。這是我們顯然已經考慮過的事情。正如我們在之前的討論中所說的那樣，我們認為實現其中一些里程碑可以降低業務風險並為我們創造價值。因此，從總體上看，我們正在考慮實現一些重要的里程碑，並且知道我們有足夠的現金來實現這些里程碑，這是等待事情進展的決定性因素。

And obviously, the stock as you mentioned, the stock is up a bit. That actually pushes more in the favor of being able to do something. But we still feel we have, substantial cash runway and we have relatively near-term milestones that will be value creating. Aaron, anything?

顯然，正如您所說，該股股價有所上漲。這其實更有利於做某件事。但我們仍然覺得我們擁有充足的現金流，並且我們擁有能夠創造價值的相對近期的里程碑。亞倫，有什麼事嗎？

I will just add, I mean, we're less than a year out from our spin as well. We've got just about $700 million on our balance sheet. So Doug, I think it's something that we're going to continue to look at and work about work on and think about with our board. So it's on our minds, but we're in a good position now in our view.

我只想補充一點，我們的分拆才不到一年的時間。我們的資產負債表上大約有7億美元。所以道格，我認為這是我們將繼續研究、努力並與董事會一起思考的事情。所以這是我們所考慮的問題，但我們認為我們現在處於有利地位。

Kyle Mikson, Canaccord.

凱爾米克森（Kyle Mikson），Canaccord。

Thanks guys for the questions. Just on NHS first, just given the data here and the partnership and the study, keep progressing, how are the recent conversations with NHS going and do you, what do you expect they're going to do, I guess, with Galleri commercialization in the country of following the full readout in 2026?

謝謝大家的提問。首先談談 NHS，鑑於這裡的數據、合作關係和研究，請繼續關注進展情況，最近與 NHS 的對話進展如何？您預計他們將如何在 2026 年全面公佈後對 Galleri 在該國的商業化進行改進？

And then secondly, for maybe Harpal, on the PPV for the subset here that you provided, is that like a modeled number or is that like a concrete metric? I just want to kind of understand. If it's like how the number should be used and it's like how much materially higher it is compared to like Pathfinder, for example? Thanks.

其次，對於 Harpal 來說，您提供的子集的 PPV 是一個模型數字還是一個具體的指標？我只是想稍微了解一下。如果它像應該如何使用數字，以及它與 Pathfinder 相比實際上高出多少？謝謝。

Thanks, Kyle. So let me quickly take the second question first. So when we say the PPV was substantially higher in the first round, that's a concrete number. We're not sharing what that number is, but we can say it's substantially higher than the 43% that we saw in Pathfinder. So it's not a model number.

謝謝，凱爾。那麼讓我先快速回答第二個問題。因此，當我們說第一輪的 PPV 明顯更高時，這是一個具體的數字。我們不會透露這個數字，但我們可以說它比我們在 Pathfinder 中看到的 43% 高得多。所以它不是一個型號。

With respect to the conversations with the NHS, I mean, just to say that we're in constant dialogue with the NHS and with the National Screening Committee in the UK and with the government in the UK. They are clear that they want to wait to see final results from all three rounds of the study before they will make a decision as to if and when to roll out a screening program in the UK or in England particularly. So I can't give you anything more concrete than that at this point other than to say we're in constant dialogue.

關於與 NHS 的對話，我的意思是，我們一直在與 NHS、英國國家篩選委員會和英國政府保持對話。他們明確表示，他們希望等待所有三輪研究的最終結果，然後再決定是否以及何時在英國或特別是在英格蘭推出篩檢計畫。因此，除了說我們正在不斷對話之外，我現在無法給你任何更具體的資訊。

They are maybe go through a little bit of the why not reveal the numbers right now.

他們也許正在考慮為什麼現在不透露這些數字。

Yeah, sure. So I mean it's important to reiterate that the NHS Galleri trial was designed as a three-year screening study. In other words, we do three rounds of screening, and that's very common in screening trials and in and in studies of screening because for the reasons that I stated earlier on the call. If you only look at one round of screening, then what you'll typically find in that first round is a lot of prevalent asymptomatic cancers in the population, which can often be late stage but haven't yet been diagnosed.

是的，當然。因此，我有必要重申，NHS Galleri 試驗旨在作為為期三年的篩檢研究。換句話說，我們進行三輪篩檢，這在篩檢試驗和篩檢研究中非常常見，原因我在電話中早些時候已經提到過。如果只看一輪篩檢，那麼在第一輪你通常會發現人群中存在許多普遍的無症狀癌症，這些癌症通常處於晚期但尚未被診斷出來。

By going to a second and third round, you start to see what the impact of a, if you like, a more established or steady state screening program might be. And so it's really important that we safeguard those upcoming readouts and the integrity of the trial as a whole. It's also really important that we safeguard the interests of the participants taking part in the trial.

通過第二輪和第三輪，你開始看到更成熟或更穩定的篩選程序可能產生的影響。因此，我們必須確保即將發布的讀數和整個試驗的完整性。維護參加試驗的參與者的利益也非常重要。

And so for all of those reasons, we're not sharing more detailed information at this stage. But we are now getting closer to having the final results middle of next year, and we look forward to sharing all of those both with all of you, but also with the NHS at that time.

由於所有這些原因，我們現階段不會分享更詳細的資訊。但現在我們即將在明年年中得到最終結果，我們期待屆時與大家以及 NHS 分享所有這些結果。

Great, that was super helpful. And on the topic of repeat testing, it sounds like that me remains stable. I think I heard 20%, continues. So when you think about repeat testing, what's an acceptable number at this point, do you like 20%? How do you improve the stickiness and that recurring kind of revenue stream? And then how does movement in that number affect your modeling of like ASP and customer acquisition cost over the medium term?

太棒了，這非常有幫助。關於重複測試的話題，聽起來我仍然保持穩定。我想我聽到的是 20%，繼續說。因此，當您考慮重複測試時，此時可接受的數字是多少，您喜歡 20% 嗎？如何提高黏性和經常性收入流？那麼，這個數字的變化如何影響您對中期 ASP 和客戶獲取成本的建模？

Yeah, so first of all, we're very pleased with about 20%, given that we're generally not a reimbursed test. We think it compares very favorably to to reimbursed tests. The 20% mark, we expect to continue to be able to grow that, but we need a little more time on there are belts to figure out exactly where that's going to go. From a -- clearly, from a customer acquisition cost that certainly helps the model being able to have that repeat base, at that significant level, so that is something we are factoring in into our modeling.

是的，首先，考慮到我們通常不進行報銷測試，我們對大約 20% 感到非常滿意。我們認為它與報銷測試相比非常有利。我們預期 20% 這個目標能夠持續實現，但我們需要更多時間才能弄清楚這個目標到底會達到什麼程度。從客戶獲取成本來看，這顯然有助於模型能夠在如此重要的水平上擁有重複基礎，因此這是我們在建模時要考慮的因素。

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

謝謝。目前沒有其他問題。現在我將把電話轉回給 GRAIL 並請其最後發言。

So thank you everyone for joining today's call.

感謝大家參加今天的電話會議。

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

女士們、先生們，本次通話到此結束。您現在可以斷開連線。