Grail Inc (GRAL) 2025 Q2 法說會逐字稿

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

女士們、先生們，大家好，歡迎參加 GRAIL 2025 年第二季財報電話會議。（操作員指示）請注意，本次電話會議正在錄音。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, our Chief Financial Officer; Dr. Joshua Ofman, our President; Sir Harpal Kumar, our President, International Business in Biopharma; and Andy Partridge, our Chief Commercial Officer.

謝謝接線生，也謝謝大家今天加入我們。參加電話會議的有我們的執行長 Bob Ragusa、我們的財務長 Aaron Freidin、我們的總裁 Joshua Ofman 博士、我們的生物製藥國際業務總裁 Harpal Kumar 爵士以及我們的商務長 Andy Partridge。

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 made during today's call, 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.

我們將根據目前預期在本次電話會議上做出前瞻性陳述。我們的意圖是，今天電話會議上所作的所有除歷史事實陳述之外的陳述，包括有關我們預期的財務業績和商業活動的陳述，都將受到 1933 年證券法修訂版第 27A 節和 1934 年證券交易法修訂版第 21 節中關於前瞻性陳述的安全港條款的約束。

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.

前瞻性陳述受風險和不確定性的影響－實際事件或結果可能與預測或討論的大不相同。所有前瞻性陳述均基於目前可用的信息，GRAIL 不承擔更新這些陳述的義務。

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

更了解可能導致實際結果不同的風險和不確定性。我們請您參閱 GRAIL 向美國證券交易委員會提交的文件，包括 GRAIL 最新 10-Q 表季度報告中的風險因素部分。

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 financials. Reconciliations of the non-GAAP measures to the most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website. And with that, we turn to Bob.

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毛虧損，這些指標經過調整後不包括某些特定項目。我們的非公認會計準則財務指標旨在補充您對 GRAIL 財務狀況的理解。非公認會計準則 (non-GAAP) 指標與最直接可比較的公認會計準則 (GAAP) 財務指標的對帳表可在今天發布的新聞稿中查閱，該新聞稿已發佈在我們網站上。接下來，我們來談談鮑伯。

Thank you. Good afternoon, everyone, and thank you for joining us to review second quarter results. For nearly a decade, GRAIL has made key investments to advance our vision for population scale, multi-cancer early detection and establish a durable advantage in a growing field.

謝謝。大家下午好，感謝大家與我們一起回顧第二季的業績。近十年來，GRAIL 進行了重點投資，以推進我們對人口規模、多種癌症早期檢測的願景，並在不斷發展的領域建立持久優勢。

The time frame to establish evidence in this space is long, and we are setting the evidence bar high. We started population scale clinical studies years ago and now have several years of follow-up data, our pivotal implementation and clinical utility studies in the intended use population are beginning to read out, and we are delighted to see results not only confirm earlier studies, but actually improve certain performance measures as we evaluate Galleri in larger populations.

在這個領域建立證據的時間框架很長，而且我們設定的證據標準很高。我們幾年前就開始了人群規模的臨床研究，現在已經有了幾年的追蹤數據，我們在預期使用人群中的關鍵實施和臨床效用研究開始顯現成果，我們很高興看到結果不僅證實了早期的研究，而且在我們在更大的人群中評估 Galleri 時實際上改善了某些性能指標。

We plan to submit detailed results from the prespecified analysis of the first 25,000 patients in our registrational PATHFINDER 2 I study for presentation at the ESMO Congress 2025 in October. As a reminder, we announced positive top line performance and safety results from this data set in June, namely that we observed substantially greater additional cancer detection and a substantially higher positive predictive value in PATHFINDER 2 compared to the first PATHFINDER study, and Josh will describe these results further shortly.

我們計劃提交註冊 PATHFINDER 2 I 研究中前 25,000 名患者的預定分析的詳細結果，以便在 10 月的 ESMO 大會 2025 上進行展示。提醒一下，我們在 6 月宣布了該資料集的正面頂線性能和安全性結果，即與第一項 PATHFINDER 研究相比，我們觀察到 PATHFINDER 2 的額外癌症檢測率顯著提高，陽性預測值顯著提高，Josh 很快就會進一步描述這些結果。

We've been working with advocates and stakeholders to deploy MCED and we are finding aggressive cancers in real-world commercial setting, many of which are in early stages. Galleri test orders continue to grow at a strong clip with more than 45,000 Galleri commercial tests sold in the second quarter.

我們一直在與倡導者和利益相關者合作部署 MCED，並且我們在現實世界的商業環境中發現了惡性癌症，其中許多處於早期階段。Galleri 測試訂單持續強勁成長，第二季已售出超過 45,000 份 Galleri 商業測試。

As of June 30, more than 370,000 Galleri tests have been prescribed by more than 15,000 health care providers since we launched Galleri commercially in 2021. We continue to drive provider and patient awareness of the MCED opportunity and Galleri's ability to detect cancer earlier when it is more amenable to treatment. GRAIL has established several partnerships with health care systems to make Galleri available to patients, and we were very pleased to add Rush University System for Health in July.

自 2021 年 Galleri 商業化推出以來，截至 6 月 30 日，已有超過 15,000 家醫療保健提供者進行了超過 37 萬次 Galleri 測試。我們將繼續推動供應商和患者對 MCED 機會的認識，以及 Galleri 在癌症更容易治療時更早發現癌症的能力。GRAIL 已與多個醫療保健系統建立了合作夥伴關係，以便為患者提供 Galleri 服務，我們非常高興在 7 月加入了拉什大學健康系統。

Rush is one of the largest health systems in the US and the first in the Chicago area market to offer the Galleri test.

Rush 是美國最大的醫療系統之一，也是芝加哥地區第一個提供 Galleri 測試的醫療系統。

Additionally, we recently entered into a new collaboration with Everlywell, a digital health company pioneering and next generation of biomarker intelligence, and Galleri is now available for requests directly on Everlywell's website via prescription.

此外，我們最近與 Everlywell 建立了新的合作關係，Everlywell 是一家開創下一代生物標誌物智慧的數位健康公司，現在可以透過處方在 Everlywell 網站上直接接受 Galleri 的請求。

We remain on track for continued commercial growth in 2025. We are also encouraged by increasing Galleri volume via the Quest Diagnostic test ordering platform at midyear which follows Galleri integration into the platform earlier in 2025. In late 2024, we began the use of a new version of Galleri for which we are submitting our PMA in commercial channels.

我們仍有望在 2025 年繼續商業成長。我們也對今年年中透過 Quest Diagnostic 測試訂購平台增加 Galleri 交易量感到鼓舞，此前 Galleri 已於 2025 年初整合到該平台中。2024 年末，我們開始使用新版本的 Galleri，並正在商業管道提交 PMA。

This new version incorporates an industrial scale platform with significant automation intended to enable us to scale more efficiently with future demand. As a result of the scale and complexity of the system, there are certain new processes to sort through with a large-scale rollout.

這個新版本採用了具有高度自動化的工業規模平台，旨在使我們能夠根據未來的需求更有效地擴展規模。由於系統的規模和複雜性，大規模推廣時需要整理一些新流程。

For example, for a small proportion of samples, we've experienced increased turnaround times with higher reprocessing costs. We are now working to implement the fix to this issue.

例如，對於一小部分樣本，我們的周轉時間增加了，而且再處理成本也更高。我們現在正在努力修復該問題。

Before I hand it over to Josh, I'd like to notify the group that we will host our 2025 Analyst Day in November. Features speakers will detail key study results in clinical surveillance findings. Frame our upcoming longitudinal clinical utility data and describe firsthand customer experience with Galleri.

在將其交給喬希之前，我想通知小組，我們將於 11 月舉辦 2025 年分析師日。專題演講者將詳細介紹臨床監測結果中的關鍵研究結果。建立我們即將推出的縱向臨床實用數據並描述客戶對 Galleri 的第一手體驗。

Event details will be announced at a later date. Josh, please go ahead.

活動詳情將於稍後公佈。喬希，請繼續。

Thanks, Bob, and hello, everyone. We've spoken in the past about key performance metrics, features and capabilities for multi-cancer early detection tests, which are quite different from those for single cancer screenings. Most critically, any test developer must confirm clinical validation in the intended use population of a symptomatic adults eligible for screening before they introduce those tests into clinical practice.

謝謝，鮑勃，大家好。我們過去曾討論過多種癌症早期檢測測試的關鍵性能指標、特徵和能力，它們與單一癌症篩檢有很大不同。最重要的是，任何測試開發人員在將這些測試引入臨床實踐之前，都必須在符合篩檢條件的有症狀成年人的預期使用人群中確認臨床驗證。

This critical criteria was the reason that GRAIL did not introduce Galleri into clinical practice until we saw the results from the PATHFINDER trial in the screening population, even test with strong results in observational case-controlled studies, may fail to confirm those results in the actual screening population. Full clinical validation requires demonstration of compelling performance in the intended use population.

這個關鍵標準是 GRAIL 沒有將 Galleri 引入臨床實踐的原因，直到我們看到 PATHFINDER 試驗在篩檢族群中的結果，即使在觀察性病例對照研究中取得了強有力的結果，也可能無法在實際篩檢族群中證實這些結果。完整的臨床驗證需要在預期使用人群中證明令人信服的性能。

It is simply not possible to know the benefits and potential harms of any test before being adequately studied in the intended use population. It is also important to note that any multi-cancer test seeking FDA approval will need to demonstrate this as well.

在對預期使用人群進行充分研究之前，根本不可能知道任何測試的好處和潛在危害。還要注意的是，任何尋求 FDA 批准的多癌症測試也需要證明這一點。

So in terms of performance metrics, we've discussed what we consider to be most clinically important for MCED, positive predictive value, or PPV, which tells us among positive test results, how many cancers are found or how many are actually true positives. And the specificity critically important, which defines the false positive rate, as well as the cancer detection yield when added to standard of care screening and the ability to localize where the body a cancer signal is coming from.

因此，就表現指標而言，我們討論了我們認為對 MCED 具有臨床重要性的內容，即陽性預測值或 PPV，它告訴我們在陽性檢測結果中發現了多少癌症或有多少實際上是真正的陽性。特異性至關重要，它決定了假陽性率，以及在添加到標準護理篩檢中的癌症檢測率和定位癌症訊號來源的能力。

After hundreds of thousands of commercial tests performed, we've now confirmed how essential it is for any MCED test to report a predicted CSO or cancer signal origin to guide an efficient and effective clinical workup.

在進行了數十萬次商業測試後，我們現在已經確認，任何 MCED 測試報告預測的 CSO 或癌症訊號來源對於指導高效有效的臨床檢查是多麼重要。

We believe that any other approach, such as relying on whole-body imaging with its radiation exposure, costs and lack of any performance or safety data is simply not practicable.

我們認為，任何其他方法，例如依賴全身成像及其輻射暴露、成本以及缺乏任何性能或安全數據，都是根本不可行的。

Our first clinical implementation study, PATHFINDER, which was presented at ESMO in 2022, and showed that Galleri more than doubled the number of cancers identified when added to standard of care screening. About half of the MCED detected cancers were at early stage.

我們的第一個臨床實施研究 PATHFINDER 於 2022 年在 ESMO 上展示，結果表明，在標準護理篩檢中加入 Galleri 後，發現的癌症數量增加了一倍以上。大約一半的 MCED 發現的癌症處於早期階段。

And about 70% of the MCED detected cancers had no recommended screenings at all. The positive predictive value for Galleri in the study population was 43%. And which, as you recall, is an order of magnitude higher than leading single cancer screening tests, whose PPVs remain in the single digits.

大約 70% 的 MCED 發現的癌症根本沒有建議的篩檢。研究族群中 Galleri 的陽性預測值為 43%。並且，正如您所記得的那樣，它比領先的單一癌症篩檢測試高出一個數量級，而後者的 PPV 仍保持在個位數。

Galleri specificity was 99.5% and its cancer signal of origin accuracy was 88%. We have subsequently undertaken PATHFINDER 2 similarly designed as a prospective multi-centre interventional study of Galleri added to standard of care screening designed to assess the performance and safety of Galleri in an even larger and more representative intended-use population.

Galleri 特異性為 99.5%，其癌症起源訊號準確率為 88%。隨後，我們進行了類似設計的 PATHFINDER 2，作為對 Galleri 的前瞻性多中心幹預研究，增加了標準護理篩檢，旨在評估 Galleri 在更大、更具代表性的預期用途人群中的表現和安全性。

As Bob said, we observed a number of very promising results in the prespecified analysis of the first 25,000 participants enrolled with 12 months follow-up and shared top line results in June.

正如鮑勃所說，我們在對前 25,000 名參與者進行預先指定的分析中觀察到了許多非常有希望的結果，並進行了 12 個月的跟踪，並於 6 月份分享了最重要的結果。

First, adding Galleri to standard of care screening in PATHFINDER 2 demonstrated substantially greater additional cancer detection than that observed in the first PATHFINDER study, that is substantially greater than the more than doubling of the overall number of cancers detected when added to standard of care in the first PATHFINDER study.

首先，將 Galleri 添加到 PATHFINDER 2 的標準護理篩檢中，顯示出比第一個 PATHFINDER 研究中觀察到的更多的額外癌症檢測，這遠高於第一個 PATHFINDER 研究中添加到標準護理中時檢測到的癌症總數的兩倍以上。

Second, data showed a substantially higher positive predictive value than that observed in the first PATHFINDER study, which was 43%. Third, specificity and CSO accuracy were consistent with that observed in the first PATHFINDER study. And finally, there were no serious safety concerns reported in PATHFINDER 2.

其次，數據顯示陽性預測值明顯高於第一項 PATHFINDER 研究的陽性預測值 43%。第三，特異性和 CSO 準確性與第一項 PATHFINDER 研究中觀察到的一致。最後，PATHFINDER 2 沒有報告任何嚴重的安全問題。

We're enormously pleased with the top line results from both of our registrational PATHFINDER 2 and the NHS Galleri randomized clinical trial. You will recall in May that we completed a review of Galleri test performance results in the intervention arm from the prevalent screening round of the registrational NHS Galleri trial.

我們對註冊 PATHFINDER 2 和 NHS Galleri 隨機臨床試驗的最高結果感到非常滿意。您可能還記得，我們在五月完成了對註冊 NHS Galleri 試驗普遍篩檢輪調介入組中 Galleri 測試表現結果的審查。

Data from the prevalence screening round showed a substantially higher positive predictive value than that observed in the first PATHFINDER study. Specificity and CSO accuracy were consistent with that observed in the first PATHFINDER study. And again, there were no serious safety concerns observed in PATHFINDER 2, also consistent with the first PATHFINDER study.

盛行率篩檢數據顯示陽性預測值明顯高於第一次 PATHFINDER 研究的觀察結果。特異性和 CSO 準確性與第一項 PATHFINDER 研究中觀察到的一致。而且，PATHFINDER 2 中沒有觀察到嚴重的安全問題，這也與第一次 PATHFINDER 研究一致。

These top line findings from NHS Galleri PATHFINDER 2 confirm and extend what we already know about our multi-cancer early detection technology. The technology has been validated through many robust studies, including intended-use populations and through hundreds of thousands of commercial and clinical study test results showing very consistent results.

NHS Galleri PATHFINDER 2 的這些頂級發現證實並擴展了我們對多種癌症早期檢測技術的已知知識。該技術已通過許多強有力的研究得到驗證，包括預期使用人群，並通過數十萬個商業和臨床研究測試結果顯示出非常一致的結果。

Data presented at the ASCO Annual Meeting 2025 in May included a five-year follow-up analysis of the circulating cell-free genome ATLAS study, which demonstrated Galleri's preferential detection of aggressive and clinically meaningful cancers.

今年 5 月舉行的 ASCO 2025 年年會上公佈的數據包括對循環無細胞基因組 ATLAS 研究的五年追蹤分析，該分析證明了 Galleri 對侵襲性和具有臨床意義的癌症的優先檢測。

These findings were consistent with earlier analysis assessing the prognostic importance of Galleri's cell-free DNA-based methylation approach. Between case controlled studies and prospective implementation studies in the intended use population, we have not seen deterioration in the key performance metrics.

這些發現與早期評估 Galleri 基於無細胞 DNA 甲基化方法的預後重要性的分析一致。在針對預期使用族群的病例對照研究和前瞻性實施研究之間，我們並未發現關鍵績效指標的惡化。

Many of you will know, this is not always the case, case control performance often doesn't carry over into the real world, but we saw no deterioration in specificity, positive predictive value or cancer detection yield.

你們中的許多人會知道，情況並非總是如此，病例控製表現通常不會延續到現實世界，但我們並未看到特異性、陽性預測值或癌症檢測產量的下降。

And now we're moving into readouts of much larger registrational studies in the intended use groups as well as analyses performed by large health systems who have actual clinical experience with Galleri, and we're seeing a body of results with substantially improved PPV figures and substantially higher cancer detection numbers while other key figures like specificity and CSO accuracy remain consistent.

現在，我們正在對預期使用群體中進行更大規模的註冊研究進行讀出，以及對擁有 Galleri 實際臨床經驗的大型醫療系統進行的分析，我們看到了大量結果，PPV 數據大幅改善，癌症檢測數量大幅提高，而特異性和 CSO 準確性等其他關鍵數據保持一致。

Earlier in GRAIL's development phase of our MCAD technology, we deployed a very rigorous, unbiased and comprehensive discovery approach to identify the effective genomic features for early cancer screening. Out of those approaches evaluated, methylation patterns exhibited the strongest performance for both sensitive and specific cancer signal detection and accurate prediction of the cancer signal origin.

在 GRAIL 的 MCAD 技術開發階段早期，我們部署了一種非常嚴格、公正和全面的發現方法來識別早期癌症篩檢的有效基因組特徵。在評估的這些方法中，甲基化模式在敏感和特異的癌症訊號檢測以及對癌症訊號來源的準確預測方面表現出最強的性能。

Adding other analytes or DNA features did not improve the performance. What we are seeing today from our growing data set strengthens our conviction in our targeted methylation approach, which is focused on highly informative and low noise methylation regions known to be informative for cancer.

添加其他分析物或 DNA 特徵並不能提高性能。今天，我們從不斷增長的數據集中看到的情況增強了我們對靶向甲基化方法的信心，該方法專注於已知對癌症具有信息量的高信息量和低噪音甲基化區域。

Through hundreds of thousands of samples run in both clinical studies and commercially, we're seeing very strong positive predictive values in cancer detection rates and a highly accurate cancer signal aversion prediction, all of which critically is achieved at a very low false positive rate of 0.5%, which befits population scale testing.

透過臨床研究和商業運行的數十萬個樣本，我們看到癌症檢測率具有非常強的陽性預測值，並且癌症訊號厭惡預測非常準確，所有這些都是在 0.5% 的極低假陽性率下實現的，這適合人口規模測試。

Remember, if another test developer is operating at a lower specificity, a difference in specificity of 99.5% to 98.5% is actually 3 times higher false positive rate. That's really important to remember. We reported top line results from PATHFINDER 2 in order to preserve detailed results for a major medical meeting, and we hope to present the full data set at ESMO in October. We look forward to discussing detailed results from PATHFINDER 2 with you potentially very soon.

請記住，如果另一個測試開發人員以較低的特異性進行操作，則 99.5% 和 98.5% 的特異性差異實際上是 3 倍的假陽性率。記住這一點確實很重要。我們報告了 PATHFINDER 2 的頂線結果，以便為大型醫學會議保留詳細結果，我們希望在 10 月的 ESMO 上展示完整的資料集。我們期待很快與您討論 PATHFINDER 2 的詳細結果。

I'll now hand off to Aaron for a review of the financials.

我現在將把財務狀況的審查交給 Aaron。

Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the second quarter. Overall, second quarter results were strong. Revenue for the quarter was $35.5 million, up $3.5 million or 11% as compared to the second quarter of 2024. Total revenue for the quarter is comprised of $34.4 million of screening revenue and $1.1 million of development services revenue.

謝謝，喬希，大家下午好。我很高興地公佈我們第二季的業績。整體而言，第二季業績強勁。本季營收為 3,550 萬美元，與 2024 年第二季相比成長 350 萬美元，增幅為 11%。本季總收入包括 3,440 萬美元的篩選收入和 110 萬美元的開發服務收入。

Development service revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research and therapy development. We see continued demand for our Galleri test and sold more than 45,000 tests in the second quarter.

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。我們發現 Galleri 測試的需求持續成長，第二季銷售了超過 45,000 個測試。

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.

我們過去觀察到一年中季節性波動，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下去。

Repeat test volumes have trended higher over time, including year to date. Today, more than 25% of Galleri's volume is repeat testing. Screening revenue of $34.4 million in the second quarter was up 22% as compared with the second quarter of 2024. We US Galleri revenue was $34.2 million, up 21% compared to the second quarter last year. The second quarter has been a strong quarter for US Galleri revenue historically.

隨著時間的推移，包括今年迄今為止，重複測試量呈上升趨勢。如今，Galleri 超過 25% 的銷售量都是重複測試。第二季的放映收入為 3,440 萬美元，與 2024 年第二季相比成長了 22%。我們美國畫廊的營收為 3,420 萬美元，與去年第二季相比成長了 21%。從歷史上看，第二季一直是美國畫廊收入強勁的一個季度。

We are on track relative to our full year guidance of US Galleri revenue growth between 20% to 30%. As stated last quarter, we do not expect a major impact for tariffs on our current business as our laboratory is located in the US and a significant majority of our suppliers are located and manufacturer in the US Cost of trading revenue, exclusive of amortization of intangible assets as a percent of revenue decreased in the second quarter of 2025 and compared to the same period in 2024, primarily due to a 6% decrease in ASP and additional sample reprocessing costs, partially offset by the reduction in variable costs of Galleri testing performed on our automated platform.

我們預計美國畫廊全年營收成長率將在 20% 至 30% 之間。正如上個季度所述，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和製造商都位於美國。 2025 年第二季度，不包括無形資產攤銷的交易收入成本佔收入的百分比與 2024 年同期相比有所下降，這主要是由於平均銷售價格下降了 6% 以及樣品再處理成本增加，但在我們的自動化平台上進行的 Galleri 測試的變動成本降低部分抵消了這一影響。

Net loss for the quarter was $114 million, an improvement of 93% as compared to the second quarter of 2024. Net loss in the second quarter includes impairment of Illumina acquisition-related intangible assets of $28 million and stock-based compensation of $14.2 million. While we focus on advancing Galleri, we remain committed to our ongoing work with pharma partners, and we have confidence in the potential application of our technology.

本季淨虧損為 1.14 億美元，與 2024 年第二季相比改善了 93%。第二季淨虧損包括 Illumina 收購相關無形資產減損 2,800 萬美元及股票薪酬 1,420 萬美元。在我們專注於推進 Galleri 的同時，我們仍致力於與製藥合作夥伴的持續合作，並且我們對我們的技術的潛在應用充滿信心。

Non-GAAP adjusted gross profit for the second quarter of 2025 was $16.1 million, an increase of $0.1 million or 1% as compared with the second quarter of 2024. We ended the quarter with a cash position of $606.1 million. In January, we guided that we expect cash burn for the full year 2025 to be no more than $320 million, and we are updating the guidance to cash burn of no more than $310 million for the full year of 2025, which represents a decrease of more than 40% to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones.

2025 年第二季非公認會計準則調整後毛利為 1,610 萬美元，較 2024 年第二季增加 10 萬美元，增幅為 1%。本季末我們的現金狀況為 6.061 億美元。今年 1 月，我們預計 2025 年全年現金消耗不超過 3.2 億美元，目前我們更新了該預期，預計 2025 年全年現金消耗不超過 3.1 億美元，與 2024 年相比下降 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。

I'll turn it back to Bob for concluding remarks

我將把發言交回給鮑勃，請他做總結發言

Thank you, Aaron. The close, we are highly encouraged by the demand we are seeing today, both for new patients and for returning patients who are repeat testing. Our strategic priorities are seeking FDA approval of Galleri and pursuing broad reimbursement.

謝謝你，亞倫。最後，我們對今天看到的需求感到非常鼓舞，無論是新患者還是重複測試的回訪患者。我們的策略重點是尋求 FDA 對 Galleri 的批准並尋求廣泛的報銷。

We are advancing Galleri's today toward near-term key clinical and regulatory catalysts to achieve broad access while maintaining our disciplined cost management. We plan to submit for presentation at ESMO in October, detailed performance and safety results from the first 25,000 participants enrolled in the PATHFINDER 2 study.

我們正在推動 Galleri 朝著近期關鍵臨床和監管催化劑的方向發展，以實現廣泛的應用，同時保持嚴格的成本管理。我們計劃於 10 月向 ESMO 提交 PATHFINDER 2 研究的前 25,000 名參與者的詳細表現和安全結果。

This is a registrational data set that will go through the FDA. Soon into 2026, our key milestones are the completion of our modular PMA submission to the FDA in the first half and full clinical utility results from our 140,000 participant NHS Galleri study, which we expect to read out midyear.

這是將通過 FDA 審核的註冊資料集。很快，我們將進入 2026 年，我們的關鍵里程碑是在上半年完成向 FDA 提交模組化 PMA，以及獲得 140,000 名參與者的 NHS Galleri 研究的完整臨床實用結果，我們預計將在年中公佈這些結果。

This longitudinal data set will be reviewed by the NHS to determine Galleri's potential deployment within the UK population. As I mentioned earlier, we look forward to seeing many of you at our 2025 Analyst Day in November.

NHS 將審查這組縱向資料集，以確定 Galleri 在英國人口中的潛在部署。正如我之前提到的，我們期待在 11 月的 2025 年分析師日上見到大家。

With that, we'll turn the call over to Q&A. Operator, please go ahead.

接下來，我們將轉入問答環節。接線員，請繼續。

(Operator Instructions) Kyle Mikson, Canaccord Genuity.

（操作員指示）Kyle Mikson，Canaccord Genuity。

Hi, this is [Alex] the case on the line for Kyle Nixon. Thanks for taking my questions. I just take a step back here. So the first quarter cash run came a bit higher than we expected especially due to the bonuses that you have pay out in the prior year period in 1Q, but that's obviously an in future quarters. You modestly improved the burn target for 2025. Can you just comment on 2Q free cash burn?

你好，我是 [Alex]，負責 Kyle Nixon 的案子。感謝您回答我的問題。我只是在這裡退一步。因此，第一季的現金流比我們預期的要高一些，特別是由於您在第一季度支付了去年同期的獎金，但這顯然是未來幾個季度的事情。您略微提高了 2025 年的燃燒目標。您能評論一下第二季的免費現金消耗嗎？

And then just given how integral the burn is to your story, can you elaborate on any other dynamics that could impact cash burn in second half '25, whether that be additional R&D increases the head count or any other one-offs?

然後，考慮到燒錢對於您的故事有多重要，您能否詳細說明可能影響 25 年下半年現金消耗的任何其他動態，無論是額外的研發增加員工人數還是任何其他一次性事件？

Yeah, you want, Aaron, you want to take that one?

是的，亞倫，你想拿那個嗎？

Yeah, happy to -- Yeah, thanks for the question. So I think we've -- first 6 months, it was about $160 million of burn. And it is important for us to, again, as Bob said, manage the business as efficiently as possible. We do see that coming down in the next couple of quarters as you can get into the $310 million and more than guide that we just updated, really driven by increased volumes in the back half of the year, and increased revenue. And also, we'll be working on -- working through some of the -- getting more volume on our new automated platform.

是的，很高興——是的，感謝您的提問。所以我認為，前 6 個月我們的損失大約是 1.6 億美元。正如鮑伯所說，對我們來說，盡可能有效率地管理業務非常重要。我們確實看到這一數字在接下來的幾個季度內會下降，因為您可以進入我們剛剛更新的 3.1 億美元及以上的指南，這實際上是受到下半年銷量增加和收入增加的推動。此外，我們還將致力於透過一些努力，在我們的新自動化平台上獲得更多的交易量。

Yeah, I'd like maybe just add a little color to that too. One of the things when we did the restructuring, we wanted to make sure that we gave ourselves lot of flexibility in the go-forward state and recognizing that MCED being a new field, we undoubtedly face a number of new and interesting challenges. So that flexibility was a key element. And I think by doing the restructuring, getting us cash into 2028, has provided that. And I think being able to guide down a little bit to $310 million shows we're -- we think we're on track to be able to hit that more aggressive number.

是的，我可能也想給它一點顏色。我們進行重組時要做的一件事是確保我們在前進的道路上給予自己很大的靈活性，並認識到 MCED 是一個新領域，我們無疑面臨著許多新的、有趣的挑戰。因此靈活性是一個關鍵因素。我認為，透過重組，我們可以獲得 2028 年的現金，從而實現這一點。我認為，能夠將目標稍微下調至 3.1 億美元表明我們——我們認為我們有望達到這個更積極的數字。

I thank you for the color.

我感謝你的顏色。

Subbu Nambi, Guggenheim.

蘇布南比 (Subbu Nambi)，古根漢美術館。

Hey guys, thank you for taking my question. Just to clarify, do you not need full longitude clinical utility data that is expected mid-2026 for PMA submission one?

嘿夥計們，謝謝你們回答我的問題。只是為了澄清一下，您是否不需要預計在 2026 年中期提交的 PMA 完整經度臨床實用數據？

And then when you say significantly higher PPV in PATHFINDER 2, I had a basic question. Are you normalizing for cancer prevalence in both these studies just because shouldn't cancer prevalence impact PPV?

然後，當您說 PATHFINDER 2 中的 PPV 明顯更高時，我有一個基本問題。您是否在這兩項研究中都對癌症盛行率進行了標準化，只是因為癌症盛行率不應該影響 PPV？

Yeah, maybe, I'll start off. Thanks for the questions. So on the clinical utility question, so the FDA, if you go back to their Advisory Board meeting, they're really going to be looking at benefits harms -- view of the world. And so they are not going to be looking at clinical utility and typically don't for the approvals.

是的，也許，我先開始了。感謝您的提問。因此，關於臨床實用性問題，如果你回顧 FDA 的顧問委員會會議，你會發現他們實際上會專注於益處與危害——世界觀。因此他們不會考慮臨床實用性，通常也不會尋求批准。

That gets more -- much more into the payer discussion. So the payers would more typically look at that -- but that -- and that's what the NHS Galleri data will provide. Josh, do you maybe want to take the PPV question on PATHFINDER 2?

這更多地涉及到付款人的討論。因此，付款人通常會注意這一點 — — 但這一點 — — 而這正是 NHS Galleri 數據所提供的。喬希，你想回答關於 PATHFINDER 2 的 PPV 問題嗎？

Sure. So, again, on the FDA they're going to be focused on clinical validation. Rather than clinical validity, utility, excuse me, clinical validation, not clinical utility, and they will, and they've said that in their own advisory board, as Bob said. On the PPV, right now we are not normalizing that for the standard population. We're reporting it out within each study's population. As we mentioned earlier, these are much broader, more diverse and more representative populations.

當然。因此，FDA 將再次關注臨床驗證。而不是臨床有效性、實用性，對不起，是臨床驗證，而不是臨床實用性，他們會的，而且他們在自己的顧問委員會中也這麼說過，正如鮑勃所說的那樣。對於 PPV，目前我們還沒有針對標準族群進行標準化。我們正在針對每項研究的人群進行報告。正如我們之前提到的，這些群體更加廣泛、更加多元、更具代表性。

Than has been studied previously. And so we're expecting that, there will be a more diverse cancer risk in that population and cancer incidence, which may be driving the higher PPV. And so we will ultimately, normalize all of this for cancer incidents and the cancer case mix, which is the distribution of cancers within each population, which is enormously important.

比以前研究過的還要多。因此，我們預計該族群的癌症風險和癌症發生率將更加多樣化，這可能會導致 PPV 更高。因此，我們最終將使所有這些癌症發病率和癌症病例組合（即每個人群中的癌症分佈）正常化，這非常重要。

For performance, reporting. We will ultimately do that, but today we're just reporting them within the study population themselves.

為了表現，報告。我們最終會這樣做，但今天我們只是在研究人群中報告這些情況。

Thank you so much for clarifying that. And then one follow up, non sequitur. Based on other prior integrations with more concierge type testing platforms like Function and Superpower, how long is a typical growth ramp and do you expect early well to drive similar volumes?

非常感謝您澄清這一點。然後還有一次後續行動，不合邏輯。根據之前與 Function 和 Superpower 等更多禮賓類型測試平台的其他集成，典型的增長週期是多長？您是否預計早期能夠推動類似的成長？

Yeah, so we have seen, good consistent performance out of, groups like Function, and, been very good partners. We anticipate that inevitably will add an important dimension to the channel, with, a whole another outlet given their subscriber base. Maybe Andy, do you want to, Andy Park, CCO, you want to add some color to that.

是的，我們看到 Function 等團體表現出色，並且是非常好的客戶合作夥伴。我們預計，這必然會為該頻道增添一個重要維度，為其訂閱用戶群提供另一個全新的管道。也許安迪，你想，安迪帕克，首席文化官，你想為它添加一些色彩。

Yeah, absolutely. So yeah, we're definitely anticipating these telemedicine, longevity-based platforms like Function Health, like Everlyewell to really give us a tailwind in terms of growth going forward. When we look at Everylywell, they've had millions of customers order through that platform and Everylywell in terms of the Everly360 launch that they announced offering Galleri as an add-on, and they've e-mailed hundreds of thousands of their customers about the Galleri multi-cancer early detection test. So we're excited to partner with groups like Function health, like Everlywell as they really amplify our education around Galleri and multi-cancer early detection.

是的，絕對是如此。所以，是的，我們確實期待這些遠距醫療、基於長壽的平台（例如 Function Health、Everlyewell）能真正為我們未來的成長帶來順風。就 Everylywell 而言，他們已經有數百萬客戶透過該平台訂購，並且 Everylywell 就 Everly360 的推出宣布提供 Galleri 作為附加組件，並且他們已經向數十萬客戶發送了有關 Galleri 多癌症早期檢測測試的電子郵件。因此，我們很高興能與 Function health、Everlywell 等團體合作，因為他們確實擴大了我們在 Galleri 和多種癌症早期檢測方面的教育。

Perfect. Thank you.

完美的。謝謝。

Yuko Oku, Morgan Stanley.

奧裕子，摩根士丹利。

Hello, thank you for taking my questions. With timelines for PMA submission approaching, could you elaborate on customer support infrastructure in place to help integrate MCED testing in cancer care today. And then outside of sales reps, what are areas you intend to bolster as you get closer to the timing of anticipated FDA approval?

您好，感謝您回答我的問題。隨著 PMA 提交時間的臨近，您能否詳細說明現有的客戶支援基礎設施，以幫助將 MCED 測試整合到當今的癌症治療中。那麼，除了銷售代表之外，隨著 FDA 批准時間的臨近，您還打算加強哪些方面？

Yeah, so the timeline for our PMA submission is first half of next year 2026. We're anticipating beyond that for FDA approval about a one year process since we believe this is the first MCED that we'll go through the FDA, we believe it will be about a one year process due to having an advisory board. So that puts you out into kind of mid first half -- first half 2027. And with that, we've been consistently ramping our customer support, both size as well as capability in line with the growth of the business.

是的，我們提交 PMA 的時間表是明年 2026 年上半年。我們預計 FDA 的批准過程大約需要一年時間，因為我們相信這是我們通過 FDA 的第一個 MCED，由於設有顧問委員會，我們相信這將是一個大約一年的過程。因此，這意味著你將進入上半年中期——2027 年上半年。同時，我們一直在隨著業務的成長不斷擴大我們的客戶支援規模和能力。

So we would assume that we would continue to do that. We're obviously looking for efficiencies in the way we deliver that customer support going through that process.

因此我們認為我們會繼續這樣做。顯然，我們正在尋求提高整個流程中提供客戶支援方式的效率。

In terms of other elements, we -- at that point, we'll be looking at from a -- certainly from a sales and marketing perspective, how much effort we're going to be putting in as well, and also looking at from a cost perspective, we expect some step downs in costs in other areas of the business as we get through those important milestones. Andy, anything you want to add on the customer support side?

就其他因素而言，到那時，我們將從銷售和行銷的角度來看待我們將投入多少精力，同時從成本的角度來看，我們預計，隨著我們實現這些重要的里程碑，其他業務領域的成本將會下降。安迪，關於客戶支援方面還有什麼要補充的嗎？

Yeah, I think you covered it, Bob., we're really looking at what are those opportunities to expand our customer-facing teams. We're going to do that to capture those growth opportunities. We're also going to continue to keep an eye on expenses. As you outlined, Bob, as we really want to drive to kind of a commercial breakeven kind of going forward, so.

是的，鮑勃，我想你已經說清楚了，我們確實在尋找擴大面向客戶的團隊的機會。我們將這樣做以抓住這些成長機會。我們也將繼續關注開支。正如鮑伯所概述的，我們確實希望在未來實現商業收支平衡。

Great. And if I could squeeze 1 more in, if I may. Could you elaborate on the statistical powering of the NHS Galleri study what difference is the trial powered to detect on the primary endpoint of reduction in the incidence of late-stage cancer versus the control arm? And what result will be viewed as meaningful benefit?

偉大的。如果可以的話，我可以再擠進 1 個。您能否詳細說明 NHS Galleri 研究的統計功效？與對照組相比，該試驗在檢測晚期癌症發生率降低的主要終點有何差異？什麼樣的結果才算是有意義的利益？

Yeah, Harpal, you maybe you want to take that one?

是的，哈帕爾，也許你想拿那個？

Yeah, sure, So I mean the study is powered to show a significant reduction in late-stage cancer. So we -- the primary endpoint is a reduction in stage three and four cancers. And we look first at the 12 cancers that represent about 2/3 of all cancer mortality and then we go on to look at all cancers from there.

是的，當然，所以我的意思是這項研究有力地表明晚期癌症的發生率顯著降低。因此，我們的主要終點是減少第三期和第四期癌症。我們首先研究佔所有癌症死亡率 2/3 的 12 種癌症，然後再研究從那裡開始的所有癌症。

So we will be looking at that late-stage reduction. We don't have a specific reduction in mind, but it's -- but the size of the study was set to be able to deliver a statistically significant result in terms of that reduction. So we will see what that reduction ends up being.

因此我們將關注後期的減量。我們並沒有考慮具體的減少量，但是－研究的規模設定為能夠在減少量方面提供具有統計意義的結果。因此我們將看看最終的減幅是多少。

We're interested, obviously, both in reduction of stage three and four cancers, but also stage four cancers because ultimately, people primarily die of stage four cancer. So if we can see significant reductions in those late-stage cancers, we believe this will provide substantial benefit to the population.

顯然，我們不僅對減少三期和四期癌症感興趣，而且對減少第四期癌症也感興趣，因為最終人們主要死於第四期癌症。因此，如果我們能夠看到晚期癌症的發生率顯著減少，我們相信這將為民眾帶來巨大的利益。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Hi, this is [Colleen] on for Doug. Thanks for taking our question. As the NHS data reads out next year, we think that could serve as a strong evidence package for other international opportunities with single payer systems. How are your conversations with territories across the globe looking to deploy gallery? Also, if international volume grows sufficiently, will you have to do a tech transfer to international labs?

大家好，我是 Doug 的 [Colleen]。感謝您回答我們的問題。隨著明年 NHS 數據的公佈，我們認為這可以成為其他採用單一支付系統的國際機會的有力證據。您與全球各地尋求部署畫廊的地區進行了怎樣的對話？此外，如果國際貿易量成長到足夠大，您是否必須向國際實驗室進行技術轉移？

Yeah, no, it's a great question. So we get a tremendous amount of inbound interest, as you can imagine, from around the globe. And with that, we've had numerous conversations. We also believe, as you rightly pointed out that in middle of next year, from an efficiency standpoint, effectiveness standpoint, in the middle of next year when we read out the NHS Galleri study, we think that's going to be a great calling card to really have significant discussions with a lot of countries around the globe, both due to just the sheer size of the study, but also the rigor and reputation those studies done on the NHS. I think that reputational advantage will go a long way as we have those conversations.

是的，不，這是一個很好的問題。因此，正如您所想像的，我們獲得了來自世界各地的大量關注。就此，我們進行了多次對話。我們也相信，正如您正確指出的那樣，從效率和有效性的角度來看，明年年中，當我們宣讀 NHS Galleri 的研究報告時，我們認為這將成為一張很好的名片，可以與全球許多國家進行真正重要的討論，這不僅是因為研究規模龐大，還因為這些針對 NHS 的研究的嚴謹性和聲譽。我認為，隨著我們進行這些對話，聲譽優勢將發揮很大的作用。

Harpal, anything you want to add with that?

Harpal，您還有什麼要補充的嗎？

I think you've largely covered it, Bob. I mean, as you said, this is a very large study conducted extremely well in a in a health system that is very well respected around the world. So we fully expect that the results from this study will be and are being observed by countries right across the world. We're getting, as Bob said, a lot of inbound interest from, pretty much.

我認為你已經基本講完了，鮑伯。我的意思是，正如你所說，這是一項非常大規模的研究，並且在一個世界範圍內備受尊重的醫療體系中開展得非常出色。因此，我們完全相信這項研究的結果將會被世界各國所關注。正如鮑伯所說，我們收到了很多來自外界的興趣。

Every country around the world, and we expect that the results, middle of next year will provide us with the data to really turn those conversations into meaningful opportunities as we look forward and as you alluded to, should give us a substantial growth opportunity as we look forward.

我們預計，世界上每個國家，明年年中的結果將為我們提供數據，真正將這些對話轉化為有意義的機會，正如您所提到的，這將為我們提供巨大的成長機會。

Thank you.

謝謝。

David Westenberg, Piper Sandler.

大衛‧韋斯滕伯格、派珀‧桑德勒。

Hi, this is [John] on for Dave. Can you hear me?

大家好，我是戴夫 (Dave) 的 [約翰 (John)]。你聽得到我嗎？

Yes.

是的。

Hi, this is [John] on for Dave. Can you hear me?

大家好，我是戴夫 (Dave) 的 [約翰 (John)]。你聽得到我嗎？

Yes, we can.

是的，我們可以。

Great. So just first off, Quest integrated Galleri into their ordering system earlier this year. It's still early days, but could you just give us any color on what you're seeing in terms of orders coming through at the Quest platform at this point? And any thoughts on what's driving it?

偉大的。首先，Quest 今年稍早將 Galleri 整合到了他們的訂購系統中。現在還為時過早，但您能否向我們介紹一下目前 Quest 平台上的訂單？您認為是什麼推動了這個進程？

Yeah, So maybe answer in reverse. So part of integrating with Quest is we've -- what we found is every time you remove friction from the system, we see an uplift in uplift in sales. And so we believe that Quest with their -- and the Quest integration we'll be able to give that significant kind of friction reduction in the system. What we've seen so far year-to-date, it's about 500 health care professionals have ordered the Galleri test via the Quest system.

是的，所以也許反過來回答。因此，與 Quest 整合的一部分是我們發現，每當你消除系統中的摩擦時，我們就會看到銷售額的提升。因此，我們相信，透過 Quest 及其集成，我們將能夠顯著減少系統中的摩擦。據我們了解，今年迄今為止，已有約 500 名醫療保健專業人員透過 Quest 系統訂購了 Galleri 測試。

And in Q2, we saw about 7% of the orders actually came through the Quest platform. And so we're pretty excited about the uptake on Quest being relatively quick. And as we try to onboard more practitioners, some of them can just go in immediately in order the Galleri tests on the Quest integration. While others need to specifically enable the Galleri tests, that enablement typically takes a few weeks to occur. And so we do anticipate that we'll continue to grow that channel.

在第二季度，我們發現大約 7% 的訂單實際上來自 Quest 平台。因此，我們對 Quest 的快速普及感到非常興奮。當我們嘗試吸收更多從業者時，其中一些可以立即加入，以便 Galleri 對 Quest 整合進行測試。雖然其他人需要專門啟用 Galleri 測試，但這種啟用通常需要幾週時間。因此，我們確實預計我們將繼續發展該管道。

And then another nice part about it is what we're finding is the Quest providers, people going through that system tend to be higher prescribers. And so we look at the ordering depth by prescriber and they tend to be some of the higher ones. So we're seeing that get enabled definitely drives increased volumes.

另一個好處是，我們發現 Quest 提供者，透過該系統的人往往是開處方更高的人。因此，我們根據開藥者查看了訂購深度，發現它們往往是較高的。因此，我們看到，啟用該功能肯定會推動銷量增加。

Great, thank you. And just a little more broadly, could you give any color on how do you interpret the repeat test rate for Galleri? Are you pleased with it? Do you have a target in mind and just any general thoughts on the directional trend for repeat testing?

太好了，謝謝。再廣泛一點，您能否解釋一下如何解釋 Galleri 的重複測試率？你滿意嗎？您是否有一個目標，並且對重複測試的方向趨勢有什麼整體想法？

Sure. So first, we're pretty pleased with repeat testing. Last quarter, we over 20% this quarter, we went to 25%. We've seen a continued step-up in repeat testing, which I think is really a testament to the -- both the product as well as the medium. We think a blood-based test is going to have a better adoption capability than some of the other medians.

當然。首先，我們對重複測試感到非常滿意。上個季度，我們的成長率超過了 20%，而本季度，我們的成長率達到了 25%。我們看到重複測試的數量持續增加，我認為這確實證明了產品和媒材的有效性。我們認為，基於血液的測試將比其他一些測試具有更好的採用能力。

And -- we also think the fact that it compares very favourably to other tests, given that it's not a non-reimbursed test generally to have repeat test rates above 25% at this stage of the game is something we're pretty happy with. And it's also something we're looking to continue to do efforts to make sure we continue to drive that higher.

而且——我們也認為，與其他測試相比，它非常有利，因為它通常不是一項不予報銷的測試，在遊戲的這個階段，重複測試率超過 25% ，這是我們非常滿意的。我們也希望繼續努力，確保繼續推動這一目標的實現。

Great, thank you.

太好了，謝謝。

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 並請他作最後發言。

I just want to thank everybody for the questions and I look forward to talking to you about the next call.

我只想感謝大家的提問，並期待與你們討論下次電話會議。

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。