Grail Inc (GRAL) 2024 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the GRAIL second quarter 2024 earnings call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised this conference call is being recorded.

女士們、先生們，美好的一天，歡迎參加 GRAIL 2024 年第二季財報電話會議。此時，所有參與者都處於只聽模式。演講者演講結束後，將進行問答環節。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。

Thank you, and thank you all for joining us today. On the call today are Bob Ragusa, our Chief Executive Officer; Aaron Freidin, our Chief Financial Officer; Dr. Joshua Ofman, our President; and Sir Harpal Kumar, our President, Biopharma Business & Europe.

謝謝大家，也謝謝大家今天加入我們。今天參加電話會議的是我們的執行長鮑勃·拉古薩 (Bob Ragusa)； Aaron Freidin，我們的財務長；我們的總裁約書亞·奧夫曼博士；以及我們的生物製藥業務和歐洲總裁 Harpal Kumar 爵士。

Before we get underway, I'd like to remind everybody that we will be making forward-looking statements on this call based on current expectations. It is 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 28 of the Securities Act of 1933 as amended, and Section 21 of the Securities Exchange Act of 1934 as amended. 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 Securities and Exchange Commission, including the Risk Factors section of GRAIL's most recently quarterly report.

在我們開始之前，我想提醒大家，我們將根據目前的預期對本次電話會議做出前瞻性聲明。我們的目的是，今天電話會議期間除歷史事實陳述之外的所有陳述，包括有關我們預期財務業績和商業活動的陳述，都將受到《證券法》第28 條中包含的前瞻性陳述的安全港條款的保護1933 年證券交易法修正案和 1934 年證券交易法第 21 條修正案。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事件或結果有重大差異。所有前瞻性陳述均基於當前可用信息，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 最近季度報告的風險因素部分。

This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss and adjusted EBITDA, 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.

此次電話會議還將討論 GAAP 結果和某些非 GAAP 財務指標，包括調整後的毛利或虧損和調整後的 EBITDA，這些指標經過調整以排除某些特定項目。我們的非 GAAP 財務指標旨在補充您對 GRAIL 財務狀況的理解。今天發布的新聞稿中提供了非公認會計準則衡量指標與最直接可比較的公認會計準則財務衡量指標的調節表，該新聞稿發佈在我們的網站上。

Thank you and good afternoon, everyone. We are pleased to review our second quarter results with you today. On today's call, we will discuss the market opportunity for Galleri, our clinically validated multi-cancer early detection blood tests, our performance in the second quarter and the progress we continue to make to change the paradigm in early cancer detection. We will also review the corporate restructuring announced today, which extends our existing cash runway into 2028.

謝謝大家，大家下午好。我們很高興今天與您一起回顧第二季的業績。在今天的電話會議上，我們將討論 Galleri 的市場機會、我們經過臨床驗證的多癌症早期檢測血液測試、我們第二季度的業績以及我們在改變早期癌症檢測範式方面繼續取得的進展。我們還將審查今天宣布的公司重組，該重組將我們現有的現金跑道延長至 2028 年。

GRAIL is focused on detecting cancer early, when it can be cured. Current recommended screening is limited, and most deadly cancers are found too late. Multi-cancer early detection or MCED is the solution for effective population screening. The market for MCED is rapidly evolving, with over 100 million individuals eligible for the Galleri test in the United States and more than 300 million in global target markets. GRAIL's robust clinical validation and commercial launch as a laboratory-developed test or LDT and our significant laboratory capacity and scalability makes us well-suited to address one of the most meaningful opportunities in health care.

GRAIL 致力於在癌症可以治癒時及早發現它。目前建議的篩檢是有限的，大多數致命的癌症發現時都為時已晚。多種癌症早期檢測（MCED）是有效人群篩檢的解決方案。 MCED 市場正在迅速發展，美國有超過 1 億人有資格參加 Galleri 測試，全球目標市場有超過 3 億人。 GRAIL 作為實驗室開發的測試或 LDT 具有強大的臨床驗證和商業發布能力，以及我們強大的實驗室能力和可擴展性，使我們非常適合抓住醫療保健領域最有意義的機會之一。

Importantly, the Galleri test was designed for population scale screening. We have an expansive clinical evidence program, which is setting the standard in MCED development. We are breaking new ground and over a period of years, we have consistently progressed through key milestones for the business. We have progressed our FDA premarket approval application or PMA, registrational studies, and a few weeks ago we announced we have completed the final study visits for 140,000 participants in the NHS-Galleri study and have completed the enrollment in the 35,000 participant PATHFINDER 2 study. We expect to submit our PMA with the clinical data from these two trials and other supplemental data in the first half of 2026.

重要的是，Galleri 測試是為人群規模篩檢而設計的。我們擁有廣泛的臨床證據計劃，為 MCED 開發制定標準。我們正在開闢新天地，多年來，我們不斷取得業務的關鍵里程碑。我們已經推進了FDA 上市前批准申請或PMA、註冊研究，幾週前我們宣布我們已經完成了NHS-Galleri 研究中140,000 名參與者的最終研究訪視，並完成了35,000 名參與者PATHFINDER 2 研究的入組。我們預計在 2026 年上半年提交包含這兩項試驗的臨床數據和其他補充資料的 PMA。

We also announced in July that we have enrolled the first participant in the Galleri Medicare study called the REACH study. This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for three annual tests to generate additional clinical validation and utility data in the Medicare population. Medicare beneficiaries are among the most at risk for cancer, due to age and other risk factors, and this population represents an enormous unmet need for early cancer detection. This study is intended to help support a Medicare coverage analysis following FDA approval.

我們也在 7 月宣布，我們已經招募了第一個參與者參加名為 REACH 研究的 Galleri Medicare 研究。這項現實世界的證據研究計劃招募 50,000 名醫療保險受益人進行三年一次的測試，以在醫療保險人群中產生額外的臨床驗證和效用數據。由於年齡和其他危險因素，醫療保險受益人是癌症風險最高的人群之一，而這一人群對早期癌症檢測的巨大需求尚未得到滿足。本研究旨在幫助支持 FDA 批准後的醫療保險覆蓋分析。

We remain pleased with the demand for Galleri that we're seeing in the pre-reimbursement environment. Through June 30th of this year, more than 215,000 commercial Galleri tests have been prescribed by more than 11,000 health care providers. GRAIL is an established market leader in the field, and we are proud of the impact that Galleri is having on patients' lives.

我們對預報銷環境中對 Galleri 的需求感到滿意。截至今年 6 月 30 日，已有超過 11,000 名醫療保健提供者開立了超過 215,000 份商業 Galleri 檢測處方。 GRAIL 是該領域公認的市場領導者，我們為 Galleri 對患者生活的影響感到自豪。

Following a portfolio review, we are reprioritizing our resources on our core MCED priorities and reduced overall spend as we progress towards completion of our registrational studies. We believe these actions will extend our anticipated cash runway from the second half of 2026 into 2028 and provide for greater flexibility. It is important to note that we do not expect that the reductions in spend and headcount will impact our PMA submission timing or NHS-Galleri or the PATHFINDER 2 readouts. As a result of focusing our resources on achieving broad Galleri reimbursement in the US and UK, we are reducing the existing headcount and planned 2024 hires by approximately 30%.

經過投資組合審查後，我們正在重新調整我們的資源優先順序，用於我們的核心 MCED 優先事項，並在完成註冊研究的過程中減少總體支出。我們相信這些行動將把我們預期的現金跑道從 2026 年下半年延長到 2028 年，並提供更大的靈活性。值得注意的是，我們預計支出和人數的減少不會影響我們的 PMA 提交時間或 NHS-Galleri 或 PATHFINDER 2 讀數。由於我們將資源集中用於在美國和英國實現廣泛的 Galleri 報銷，我們正在減少現有員工人數，並計劃在 2024 年裁員約 30%。

On our commercial team, we have been working to understand which investments provide the greatest return and have identified measurable impacts from our most successful strategies. As a result, we are streamlining our commercial sales force and medical affairs teams and focusing our field-based activities on the most productive current customers and high priority opportunities. We are maintaining sales force coverage for the majority of our current Galleri volume and active prescribers.

在我們的商業團隊中，我們一直致力於了解哪些投資可以提供最大的回報，並從我們最成功的策略中確定了可衡量的影響。因此，我們正在精簡我們的商業銷售團隊和醫療事務團隊，並將我們的現場活動重點放在當前生產力最高的客戶和高優先級機會上。我們正在維持銷售隊伍涵蓋目前 Galleri 的大部分數量和活躍處方者。

As part of this approach, we are also streamlining investments in our enterprise business, which includes our employer and life insurance businesses. Reductions in the commercial organization include management layers and commercial roles without sales responsibilities. In addition to reductions in commercial, we are making reductions in medical affairs teams involved with US Galleri provider engagement.

作為此方法的一部分，我們也簡化了對企業業務的投資，其中包括我們的雇主和人壽保險業務。商業組織的減少包括管理階層和沒有銷售職責的商業角色。除了減少商業費用外，我們還減少了參與 US Galleri 提供者參與的醫療事務團隊。

We are substantially decreasing investment in R&D related to our diagnostic aid for cancer and our minimum residual disease programs. In addition, we are making reductions in G&A to reflect the focus on our MCED opportunity. We will continue to invest in our biopharmaceutical partnerships, and are committed to working with our partners to leverage GRAIL's proprietary methylation technology in precision oncology applications. This restructure and resulting staff reductions are difficult, and we are immensely grateful to our employees who have worked hard to enable GRAIL's success to date and helped transition MCED from an idea into a reality. We wish all of our impacted employees well.

我們大幅減少與癌症診斷援助和最小殘留疾病計畫相關的研發投資。此外，我們正在減少一般行政費用，以反映我們對 MCED 機會的關注。我們將繼續投資於我們的生物製藥合作夥伴關係，並致力於與我們的合作夥伴合作，在精準腫瘤學應用中利用 GRAIL 專有的甲基化技術。這次重組和由此產生的裁員是困難的，我們非常感謝我們的員工，他們努力工作，使 GRAIL 迄今為止取得成功，並幫助 MCED 從想法轉變為現實。我們祝福所有受影響的員工一切順利。

To discuss our second quarter financial results, I'll hand it over to GRAIL's Chief Financial Officer, Aaron Freidin.

為了討論我們第二季的財務業績，我將把它交給 GRAIL 的財務長 Aaron Freidin。

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

謝謝鮑勃，大家下午好。我很高興介紹我們第二季的業績。

Second quarter results were strong, with revenue of $32 million, up $9.6 million or 43% as compared to Q2 of 2023. Total revenue for the first half of the year was %58.7 million, an increase of 40% as compared to the same period in 2023. Total revenue for the quarter is comprised of $28.2 million of screening revenue and $3.8 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.

第二季業績強勁，營收 3,200 萬美元，較 2023 年第二季成長 960 萬美元，成長 43%。 2820 萬美元的放映收入和380 萬美元的開發服務收入。開發服務收入包括我們向生物製藥和臨床客戶提供的服務，包括臨床研究、試點測試、研究和治療開發的支援。

We see continued demand for our Galleri test and sold approximately 35,200 tests in the second quarter. Screening revenue of $28.2 million in the second quarter was up 41% as compared with the second quarter of 2023. Screening revenue for the first half of 2024 was $51.7 million, an increase of 45% as compared with the same period last year. Net loss for the quarter was $1.59 billion, an increase of 721% as compared to Q2 of 2023. The increase was driven by a goodwill and intangible impairment of $1.42 billion, in addition to an increase in general and administrative expenses related to legal and professional services associated with the divestiture and higher employee compensation expenses, due to an increased headcount and employee long-term incentive awards.

我們看到對 Galleri 測試的需求持續成長，第二季售出約 35,200 份測試。第二季放映營收為2,820萬美元，較2023年第二季成長41%。本季淨虧損為 15.9 億美元，較 2023 年第二季度增長 721%。員工人數增加和員工長期激勵獎勵，與剝離相關的服務和更高的員工薪酬支出。

We additionally report non-GAAP financial measures to enhance investors' understanding of our business. These measures include adjusted gross profit or loss and adjusted EBITDA and exclude accounting impacts related to Illumina's acquisition of GRAIL. We encourage investors to carefully consider results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations.

我們也報告非公認會計準則財務指標，以增強投資者對我們業務的了解。這些指標包括調整後的毛利或虧損以及調整後的 EBITDA，並且不包括與 Illumina 收購 GRAIL 相關的會計影響。我們鼓勵投資者仔細考慮公認會計原則下的結果以及我們的補充非公認會計原則資訊以及這些簡報之間的協調。

Non-GAAP adjusted gross profit for the second quarter of 2024 was $16 million, an increase of $6.4 million or 66% as compared with Q2 of 2023. Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased Galleri volume. Adjusted EBITDA for the second quarter of 2024 was negative $139.4 million, representing an increased loss of $2.8 million or 2% as compared to Q2 of 2023. The decrease in adjusted EBITDA was driven by higher operating expenses, including onetime transaction expenses, partially offset by revenue growth over the prior-year period of $958.8 million as of June 30, 2024. As we progress Galleri through the FDA approval process and work toward broad reimbursement and have today taken some difficult steps to ensure the financial health and flexibility of the Company, we expect these cost reductions to enable a significant reduction in burn in 2025 and beyond, and extend our existing cash runway into 2028. In 2024, we expect $27 million in savings.

2024 年第二季非GAAP 調整後毛利為1,600 萬美元，與2023 年第二季相比增加了640 萬美元，即66%。規模效率。 2024 年第二季調整後EBITDA 為負1.394 億美元，與2023 年第二季相比，虧損增加了280 萬美元，即2%。性交易費用，但部分抵消了截至2024 年6 月30 日，收入較上年同期增長9.588 億美元。來確保公司的財務健康和靈活性，我們預計這些成本削減將在2025 年及以後大幅減少資金消耗，並將我們現有的現金跑道延長至2028 年。 。

Turning to guidance. With the expense reductions announced today, we expect our previous estimate of $250 million in cash burn in the second half of 2024 will come down to approximately $220 million. We expect burn in 2025 to come down significantly compared to 2024, with full-year burn of 2025 expected to be approximately $325 million. We expect that our 2024 US Galleri revenue will be in line with our guidance in May of 30% to 50% growth over 2023. However, with our debt reductions announced today, we plan for Galleri revenue to grow more moderately in 2025 and subsequent years until we receive broad reimbursement.

轉向指導。隨著今天宣布的費用削減，我們預計 2024 年下半年現金消耗 2.5 億美元將降至約 2.2 億美元。我們預計 2025 年的燒錢將比 2024 年大幅下降，2025 年全年燒錢預計約 3.25 億美元。我們預計2024 年美國Galleri 收入將與我們5 月份的指導一致，即比2023 年增長30% 至50% 然而，隨著我們今天宣布的債務削減，我們計劃Galleri 收入在2025 年及隨後幾年將成長更加溫和直到我們收到廣泛的報銷。

I'll turn it back to Bob to speak to our strategic priorities. Bob, go ahead.

我將把它轉回給鮑勃談談我們的戰略重點。鮑勃，繼續吧。

Thank you, Aaron. We are a mission-driven company and we are focused on improving cancer care and enabling broad use of Galleri. Real-world use of Galleri has detected many of the most aggressive cancers in early stages, including pancreatic, head and neck, esophageal, liver, and stomach cancers. For the majority of these cancer types, there are no other screening options available. We are passionate about our mission and energized by the powerful stories we have heard from patients who have benefited from Galleri and from physicians and health systems that are successfully implementing Galleri into their practice.

謝謝你，亞倫。我們是一家以使命為導向的公司，專注於改善癌症護理並實現 Galleri 的廣泛使用。 Galleri 在現實世界中的使用已檢測出許多早期最具侵襲性的癌症，包括胰腺癌、頭頸癌、食道癌、肝癌和胃癌。對於大多數這些癌症類型，沒有其他可用的篩檢選擇。我們對我們的使命充滿熱情，並從受益於 Galleri 的患者以及成功地將 Galleri 實施到其實踐中的醫生和衛生系統那裡聽到的強有力的故事使我們充滿活力。

We are looking forward to continuing to progress our mission, and we are committed to operating with discipline and being prudent with our spend. This year, we expect to continue enrollment in the Galleri-Medicare or REACH study, drive access to Galleri, and advance our commercial and research partnerships. We will continue to release data at scientific and medical meetings, including at ESMO in September. We also anticipate results from the first 25,000 participants in the PATHFINDER 2 study in the second half of 2025. Looking beyond, we are tightly focused on our strategic goals, seeking FDA approval of Galleri and pursuing broad reimbursement for Galleri.

我們期待著繼續推進我們的使命，我們致力於遵守紀律並謹慎支出。今年，我們預計將繼續參與 Galleri-Medicare 或 REACH 研究，推動進入 Galleri，並推動我們的商業和研究合作夥伴關係。我們將繼續在科學和醫學會議上發布數據，包括 9 月的 ESMO。我們也預計 PATHFINDER 2 研究的前 25,000 名參與者將在 2025 年下半年獲得結果。

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

這樣，我們將把通話轉入問答環節。接線員，請繼續。

Thank you. (Operator Instructions) Our first question is from Kyle Nixon at Canaccord. Please unmute yourself and begin with your question.

謝謝。 （操作員說明）我們的第一個問題來自 Canaccord 的 Kyle Nixon。請取消靜音並開始提問。

Hey, guys. Thanks for the questions and thanks for doing this update call. So I guess some there hasn't been multi-cancer detection tests like this scaled in the past and now you're kind of getting cash burn down to levels of like other precision oncology companies. What gives you confidence that this level of investment's enough to commercialize this type of [broad product]?

嘿，夥計們。感謝您提出問題，也感謝您撥打本次更新電話。所以我想有些公司過去沒有進行過這樣規模的多種癌症檢測測試，現在你的現金消耗已經降到了像其他精準腫瘤公司一樣的水平。是什麼讓您相信這種投資水準足以將此類[廣泛產品]商業化？

Kyle, thanks for the question. We've looked really carefully at our portfolio and recognize that by focusing on MCED and getting to key inflection points, particularly FDA approval of our PMA, and then on the path to broad reimbursement, is really critical for us and so that's what a lot of the changes were driven by. We've, you know, we've -- did a very careful review of what it takes to get there and so we're quite comfortable that we have the resources aligned to be able to go down that path quite successfully. We =- you know, in that area around MCED, we actually made relatively few changes. We were staying consistent on our timeline. We're staying consistent on the effort that we're applying to that area. It's really in other areas around DAC, MCED and some of the commercial elements that we've pulled back from.

凱爾，謝謝你的提問。我們非常仔細地審視了我們的產品組合，並認識到，透過專注於MCED 並達到關鍵拐點，特別是FDA 對我們的PMA 的批准，然後走上廣泛報銷的道路，對我們來說確實至關重要，所以這就是很多的變化是由推動的。我們已經，你知道，我們已經——對實現這一目標所需的條件進行了非常仔細的審查，因此我們對我們擁有的資源能夠非常成功地沿著這條道路走下去感到非常滿意。我們 =- 你知道，在 MCED 周圍的領域，我們實際上做了相對較少的改變。我們在時間表上保持一致。我們在該領域的努力保持一致。實際上是在圍繞 DAC、MCED 和我們撤回的一些商業元素的其他領域。

Thanks again. Sorry for cutting you off. So just related follow-up. How will these and when will these [con] production be phased in? I understand you're kind of implementing this now, I guess, but it's kind of midyear. So I was just curious about this and how it phases into the burn targets for next year And then when will MRD and DAC investments come back and how important are those still for the company's like long long term growth profile?

再次感謝。抱歉打斷你了。所以只是相關的跟進。這些[con]生產將如何以及何時分階段進行？我猜你現在正在實施這個，但現在已經是年中了。所以我只是很好奇這一點以及它如何逐步進入明年的燒錢目標然後 MRD 和 DAC 投資何時會回來以及這些投資對於公司的長期增長概況有多重要？

Yes, so the actions will occur occur immediately. So we're taking action right now to generate the cost savings that we're outlining. In terms of MRD and DAC, we believe we have great opportunities in both of those. We think our methylation technology is very well-suited to those. And on the precision oncology side, we're continuing supporting our biopharma partners in that. So that that work will continue. On the pure DAC and MRD work, though, we're pausing future developments in those areas and we haven't set a timeline for kind of reinvesting in those areas at this point, again, because the focus is really to drive MCED through the key inflection points.

是的，所以操作將立即發生。因此，我們現在正在採取行動，以實現我們概述的成本節約。在 MRD 和 DAC 方面，我們相信我們在這兩個方面都有很大的機會。我們認為我們的甲基化技術非常適合這些。在精準腫瘤學方面，我們將繼續為我們的生物製藥合作夥伴提供支援。以便這項工作能夠繼續下去。不過，就純粹的 DAC 和 MRD 工作而言，我們正在暫停這些領域的未來開發，目前我們還沒有設定對這些領域進行再投資的時間表，因為重點實際上是推動 MCED 通過關鍵拐點。

Next question is from Tejas Savant at Morgan Stanley. Please unmute yourself and begin with your question,

下一個問題來自摩根士丹利的 Tejas Savant。請取消靜音並開始提問，

So Aaron, could you just give us a better sense for where the largest cost saves will come from I know you highlighted all the areas in the call, but just in terms of the magnitude of the contributions from each area, some color there would be great.

所以亞倫，您能否讓我們更好地了解最大的成本節省來自哪裡，我知道您在電話會議中強調了所有領域，但就每個領域的貢獻大小而言，會有一些顏色偉大的。

Yes, I can give you some sense, and maybe Aaron can jump in with a little more color So as we mentioned, there's $27 million, we see a benefit in 2024. And overall, we expect to get 2025 down to a cash burn of $325 million. That's going to come from about a 30% reduction in both existing as well as planned requisitions for 2024, you know, existing headcount and planned reqs. Importantly, we're rolling off some of the major moves we've already done in terms of the NHS-Galleri study, we announced in July that that had finished our third year of study visits, qand so we're just doing the follow-up now on that. Similarly, with PATHFINDER 2, we completed enrollment of 35,000 people in PATHFINDER 2 and so we're in the follow-up stage of that. We're finishing up an updated version of our Galleri assay, which is really going to drive lower ongoing COGS at scale. Some of the activities, we're centralizing our CLIA lab that's currently in Menlo Park in Research Triangle into Research Triangle Park, where we have a significant facility there already at RTP. And then the reductions in R&D are primarily focused on our DAC and MRD programs where again, we think we have excellent technology that has a lot of application, but we're going to pause those for the moment, in order to just conserve resources.

是的，我可以給你一些感覺，也許亞倫可以加入更多的色彩所以正如我們提到的，有2700 萬美元，我們在2024 年看到了收益。將減少3.25 億美元。這將來自於 2024 年現有和計劃的需求減少約 30%，你知道，現有的員工人數和計劃的需求。重要的是，我們正在取消在 NHS-Galleri 研究方面已經完成的一些重大舉措，我們在 7 月宣布已經完成了第三年的研究訪問，所以我們只是在做以下工作現在就說這一點。同樣，透過 PATHFINDER 2，我們完成了 35,000 人的 PATHFINDER 2 註冊，因此我們正處於後續階段。我們正在完成 Galleri 檢測的更新版本，這確實會大規模降低持續的 COGS。其中一些活動，我們正在將目前位於門洛帕克三角研究園的 CLIA 實驗室集中到三角研究園區，我們已經在 RTP 那裡擁有了一個重要的設施。然後，研發的減少主要集中在我們的 DAC 和 MRD 項目上，我們再次認為我們擁有具有大量應用的優秀技術，但我們將暫時暫停這些項目，以便節省資源。

Then on the commercial side, where we've we spent a lot of time over the last three years really understanding where we can be the most effective and efficient in our commercial efforts. And so we're going to use those learnings and really focus on really the most productive areas of commercial to be able to continue to drive sales, as Aaron mentioned, probably at a more moderated pace, because we think in a pre-reimbursement market, this is more of an investment phase and getting ready for that broad reimbursement element. Then similarly, we're going to look at G&A reductions that will be really in line with the other reductions across the organization to be just well balanced with that.

然後在商業方面，過去三年我們花了很多時間真正了解我們在商業工作中可以在哪些方面最有效和最高效。因此，我們將利用這些經驗教訓，真正專注於最俱生產力的商業領域，以便能夠繼續推動銷售，正如亞倫提到的那樣，可能會以更溫和的速度，因為我們認為在預報銷市場，這更多的是一個投資階段，並為廣泛的報銷要素做好準備。同樣，我們將考慮 G&A 的削減，這將與整個組織的其他削減真正保持一致，以便與之保持良好的平衡。

Yes, Aaron, sorry, go ahead.

是的，亞倫，抱歉，請繼續。

Aaron, are --? No, I think we're good.

亞倫，是——？不，我認為我們很好。

Okay. All right, great. My second question was really around sort of just a progress update on The Galleri 2.0 launch and what drives your confidence that that's going to be a narrower panel, so that that will be non-inferior to the current version? Can you talk a little bit about when we could see the bridging study commence and then read out how big does that trial need to be, since ultimately that's the PMA version that goes into FDA, and the NHS and PATHFINDER trials on the older version? So any color around that would be great. Thank you.

好的。好吧，太好了。我的第二個問題實際上是關於 Galleri 2.0 發布的進度更新，是什麼讓您相信這將是一個更窄的面板，因此不會劣於當前版本？你能談談我們什麼時候可以看到橋接研究開始，然後讀出該試驗需要有多大，因為最終這是進入 FDA 的 PMA 版本，以及舊版本的 NHS 和 PATHFINDER 試驗？所以周圍的任何顏色都會很棒。謝謝。

Yes. No, great question. So we've clearly been doing a lot of work on our PMA and on the PMA version of the test. Another number of great elements. One is the scalability. We recognize that Galleri is really geared for population scale testing, and so we wanted to make sure both the cost structure as well as the scalability were set for population scale. So spent a lot of time and effort getting that piece in place.

是的。不，很好的問題。因此，我們顯然在 PMA 和測試的 PMA 版本上做了很多工作。還有一些很棒的元素。一是可擴展性。我們認識到 Galleri 確實適合人口規模測試，因此我們希望確保成本結構和可擴展性都針對人口規模進行設定。因此花費了大量的時間和精力來將這塊零件安裝到位。

And then maybe, Josh, if you want to talk about the time line and progression of the studies?

喬什，也許你想談談研究的時間線和進展？

Sure. I think one of the benefits of being in the market has been the ability to collect a lot of real-world data, which has really helped us train for the new version of the assay and gives us a lot of confidence in our ability to produce a scalable version of our assay, as Bob said, with comparable performance to our existing assay, with a smaller panel as has been described on our Capital Markets Day. So I think that we have great confidence right now that we're going to be able to get that next version solidified and out.

當然。我認為進入市場的好處之一是能夠收集大量真實數據，這確實幫助我們針對新版本的檢測進行培訓，並使我們對自己的生產能力充滿信心正如鮑勃所說，我們的檢測的可擴展版本，其性能與我們現有的檢測相當，並且具有較小的面板，如我們的資本市場日所述。因此，我認為我們現在非常有信心，我們將能夠鞏固並推出下一個版本。

As it relates to the FDA and bridging studies, those are ongoing discussions with the FDA under our breakthrough designation. We're obviously working through our clinical validation plan with the FDA and we believe we're going to be able to complete our filing in the first half of 2026 with data from our registrational studies, including bridging, to the new version.

由於它與 FDA 和橋接研究有關，因此我們正在根據突破性指定與 FDA 進行持續討論。顯然，我們正在與 FDA 合作制定我們的臨床驗證計劃，我們相信我們將能夠在 2026 年上半年完成我們的備案，其中包括我們註冊研究的數據，包括橋接新版本的數據。

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

知道了。這很有幫助。謝謝，夥計們。欣賞它。

And our final question is from Sung Ji Nam at Scotiabank. Please unmute yourself and begin with your question.

我們的最後一個問題來自豐業銀行的 Sung Ji Nam。請取消靜音並開始提問。

Hi. Thanks for taking my questions. Just a couple of clarification questions for me. For the REACH study, it looks like the primary endpoint is reduction in stage 4 cancers and just to clarify, would that be sufficient for Medicare to cover the assay following FDA clearance? And also, could you define or could you maybe give us a sense of how you define a true positive test? Would that be a positive test that's confirmed within one year of the test implementation?

你好。感謝您回答我的問題。只是向我提出幾個澄清問題。對於 REACH 研究，看起來主要終點是減少第 4 期癌症，只是想澄清一下，這足以讓醫療保險在 FDA 批准後涵蓋該檢測嗎？另外，您能否定義或能否讓我們了解您如何定義真正的陽性測試？這是在測試實施後一年內得到確認的陽性測試嗎？

Josh, you want to take those?

喬希，你想拿走那些嗎？

Sure. Good question. So the REACH study, as you said, is a real-world evidence study of 50,000 Medicare beneficiaries tested for three consecutive years, and a synthetic control that will be deriving from EMRs of health systems. The primary endpoint, as you said, is an absolute reduction in late-stage cancer. This is a post-approval study with the FDA, so it will really be used to supplement the data that we've submitted as part of our PMA. So there's no kind of registrational endpoint. As it relates to Medicare coverage, first, Medicare has to have the authority to provide coverage for Galleri, and there's obviously ongoing effort by stakeholders in Washington, D.C. to ensure that legislation is passed to make that happen. And if that happens, upon FDA approval, CMS will then undertake a national coverage analysis. And these data both will have a great deal of performance data in the Medicare beneficiaries, it will have safety data in the Medicare beneficiaries, and it will have clinical utility data in the Medicare population, and so we believe that will be really compelling and sufficient for CMS to make that determination about coverage.

當然。好問題。因此，正如您所說，REACH 研究是對 50,000 名醫療保險受益人連續三年進行測試的真實世界證據研究，也是源自衛生系統電子病歷的綜合對照。正如您所說，主要終點是晚期癌症的絕對減少。這是 FDA 的一項批准後研究，因此它將真正用於補充我們作為 PMA 的一部分提交的數據。所以不存在任何類型的註冊端點。由於它涉及醫療保險覆蓋範圍，首先，醫療保險必須有權為 Galleri 提供保險，華盛頓特區的利益相關者顯然正在努力確保通過立法來實現這一目標。如果發生這種情況，經 FDA 批准後，CMS 將進行全國覆蓋率分析。這些數據都將有大量醫療保險受益人的績效數據，將有醫療保險受益人的安全數據，並將有醫療保險人群的臨床效用數據，所以我們相信這將是真正令人信服和充分的由CMS做出有關覆蓋範圍的決定。

Got it. That's helpful. And then just on the portfolio rationalization, the MRD, I think that rationale makes sense. But for the DAC, are the existing studies not that much leverageable for this particular assay, given you're looking for symptomatic patients? And then related to that, could symptomatic patients, could they still order the test, order Galleri with a prescription -- obviously, from you guys, obviously might have to pay out of pocket, but would that still be a possibility?

知道了。這很有幫助。然後就投資組合合理化，MRD，我認為這個理由是有道理的。但對於 DAC 來說，考慮到您正在尋找有症狀的患者，現有的研究對於這種特定的檢測是否沒有太大的利用價值？與此相關的是，有症狀的患者是否仍然可以訂購檢測，透過處方訂購 Galleri——顯然，從你們那裡，顯然可能需要自掏腰包，但這仍然有可能嗎？

Yes, so we -- you know, as you recall, we published the SYMPLIFY data and we presented that. It was published in The Lancet. Really great results and shows the power of a DAC type product, and you know, with really strong both positive predictive value and negative predictive value. So we feel very, very good about the technology and right now, it's really just looking at the level of investment required to bring that as a broad-scale product out onto the market. And so when we looked at the portfolio, again, we chose to pause the DAC part of the portfolio really in favor of pushing forward with MCED as the major focus.

是的，所以我們 - 你知道，正如你所記得的，我們發布了 SYMPLIFY 數據並提出了該數據。它發表在《柳葉刀》上。結果非常好，展示了 DAC 類型產品的強大功能，而且您知道，陽性預測值和陰性預測值都非常強。因此，我們對這項技術感覺非常非常好，現在，我們實際上只是考慮將其作為大規模產品推向市場所需的投資水平。因此，當我們再次審視產品組合時，我們選擇暫停產品組合中的 DAC 部分，轉而將 MCED 作為主要重點。

Great. Thank you.

偉大的。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 進行結束語。

We want to thank everyone for joining today's call.

我們要感謝大家參加今天的電話會議。