Guardant Health Inc (GH) 2024 Q1 法說會逐字稿

Good afternoon, and thank you for joining the Guardant Health Q1 2024 earnings call. My name is Kate, and I will be the moderator for today's call. At this time, all lines are in a listen only mode and we'll be until the question and answer portion of the call. I would now like to turn the call over to Derek with Guardat health. You may proceed.

下午好，感謝您參加 Guardant Health 2024 年第一季財報電話會議。我叫凱特，我將擔任今天電話會議的主持人。此時，所有線路都處於僅監聽模式，直到呼叫的問答部分。我現在想將電話轉給德瑞克（Derek），了解瓜達特的健康狀況。您可以繼續。

Earlier today, Guardant Health released financial results for the quarter ended March 31, 2024. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Michael Bell, Chief Financial Officer.

今天早些時候，Guardant Health 發布了截至 2024 年 3 月 31 日的季度財務業績。今天與我一起加入 Guardant 的是聯合執行長 Helmy Eltoukhy； AmirAli Talasaz，聯合執行長；和首席財務官邁克爾·貝爾。

Before we begin, I need to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated.

在我們開始之前，我需要提醒您，在這次電話會議中，管理層將做出聯邦證券法含義內的前瞻性陳述。這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與預期有重大差異。

This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specific items, additional information regarding material risks and uncertainties as well as reconciliation to most directly comparable GAAP financial measures are available in the press release Guardant issued today as well as in our 10-K and other filings with the SEC.

這次電話會議還將包括對非公認會計原則財務指標的討論，這些指標經過調整以排除某些特定項目，有關重大風險和不確定性的其他信息以及與最直接可比的公認會計原則財務指標的調節可在今天發布的新聞稿中找到以及我們向 SEC 提交的 10-K 和其他文件中。

Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events or otherwise. The information in this conference call is accurate only as of the live broadcast. With that I would like to turn the call over to Helen.

Guardant 不承擔任何更新或修改財務預測和前瞻性聲明的意圖或義務，無論是因為新資訊、未來事件或其他原因。本次電話會議中的資訊僅截至直播時準確。我想把電話轉給海倫。

Thanks, Derek. Good afternoon, and thank you for joining our first quarter 2024 earnings call. Starting on slide 3, Guardant as a liquid biopsy leader for therapy selection with a robust pipeline of opportunities in tissue free MRD and cancer screening.

謝謝，德里克。下午好，感謝您參加我們的 2024 年第一季財報電話會議。從幻燈片 3 開始，Guardant 作為治療選擇液體活檢的領導者，在無組織 MRD 和癌症篩檢方面擁有強大的機會。

With a comprehensive suite of tests, we are transforming patient lives across the continuum of care. We are just scratching the surface of what we believe is a massive opportunity in front of us. At Guardant, every action is fueled by our dedication to serving patients and fulfilling our bold mission to give everyone more time free from cancer.

透過一套全面的測試，我們正在整個護理過程中改變患者的生活。我們只是觸及了我們認為擺在我們面前的巨大機會的表面。在 Guardant，我們的每項行動都源於我們致力於服務患者並履行我們的大膽使命，讓每個人有更多時間遠離癌症。

In line with that mission, I'd like to share a story of the impact our tests have on patients. In March 2022, a male in his 40s was diagnosed with stage 4 non-small cell lung cancer after he visited the hospital for gastrointestinal distress in back pain. That very same day he was given a Guardant360 CDx liquid biopsy tests at his hospital bedside and his oncologist later, followed up with the tissue to us. Within days, the Guardant360 CDx test result came back identifying and our genomic rearrangements.

根據這個使命，我想分享一個關於我們的測試對患者影響的故事。2022年3月，一名40多歲的男性因背痛胃腸道不適到醫院就診，被診斷出患有4期非小細胞肺癌。就在同一天，他在醫院床邊接受了 Guardant360 CDx 液體活檢測試，隨後他的腫瘤科醫生將組織交給了我們。幾天之內，Guardant360 CDx 測試結果就回來識別我們的基因組重排。

With this information, the patient who started in the [election] a first-line TKI treatment, just 10 days after his diagnosis within just two weeks after starting treatment that patient reported is back pain was resolved. Notably, the in-house tissue test results also confirmed a positive mutation, but the results were received five weeks after the patient had already started therapy.

有了這些信息，這位在[選舉]中開始一線 TKI 治療的患者，在診斷後僅 10 天，在開始治療後短短兩週內，患者報告的背痛就得到了解決。值得注意的是，內部組織測試結果也證實了陽性突變，但結果是在患者開始治療五週後收到的。

The rapid turnaround time enabled by Guardant360 helped result in life-saving record time to treatment. I'm pleased to share that the therapy has been successful in managing this cancer and the patient continues to do well today.

Guardant360 實現的快速週轉時間有助於創造挽救生命的治療時間記錄。我很高興地告訴大家，這種療法已經成功地控制了這種癌症，患者至今仍表現良好。

Turning to top line performance in slide 4, we had a fantastic start to the year with total revenue growing 31% to $168.5 million in the first quarter of 2024. This was driven by very strong precision oncology revenue, which increased 38% in the quarter, supported by significant Guardant360 reimbursement tailwinds as well as strong growth in clinical and biopharma volumes.

轉向幻燈片 4 的營收表現，我們今年有一個出色的開局，2024 年第一季的總收入成長了 31%，達到 1.685 億美元。這是由非常強勁的精準腫瘤學收入推動的，在 Guardant360 報銷的巨大推動力以及臨床和生物製藥銷量的強勁增長的支持下，該收入在本季度增長了 38%。

Turning to slide 5. Clinical test volume for the first quarter grew 20% year-over-year, reaching 46,900 tests. We achieved a record number of average tests for oncologists, driven by continued growth in both breadth and depth of ordering. Guardant360 continues to be the primary driver of clinical volume growth with increasing contributions from newer products such as TissueNext and Response.

轉到投影片 5。第一季臨床檢測量年增20%，達到46,900次檢測。在訂購廣度和深度持續增長的推動下，我們為腫瘤科醫生實現了創紀錄的平均測試數量。隨著 TissueNext 和 Response 等新產品的貢獻不斷增加，Guardant360 仍然是臨床數量成長的主要驅動力。

Reveal also continued to grow nicely despite our continued management of volumes ahead of broader reimbursement. Biopharma volumes were incredibly strong in the first quarter, supported by strong collaborations with our growing number of biopharma partners.

儘管我們在更廣泛的報銷之前繼續對數量進行管理，但 Reveal 也繼續保持良好成長。在與越來越多的生物製藥合作夥伴的強有力合作的支持下，第一季生物製藥銷售異常強勁。

We now have over 170 lifetime partners. Test volume grew 37% year-over-year, reaching 8,450 tests. Despite discussion of biopharma headwinds across the sector, biopharma continues to be a bright spot for Guardant. We continue to see a lot of excitement for GuardantINFINITY, our newest biopharma offering, powered by our smart liquid biopsy platform. This is an important leading indicator for future demand for our clinical tests.

我們現在擁有 170 多個終身合作夥伴。測試量年增 37%，達到 8,450 次測試。儘管整個行業都在討論生物製藥的逆風，但生物製藥仍然是 Guardant 的一個亮點。我們繼續看到 GuardantINFINITY 令人興奮，這是我們最新的生物製藥產品，由我們的智慧液體活檢平台提供支援。這是我們臨床測試未來需求的重要領先指標。

Looking more closely at some of the recent highlights within our therapy selection business on slide 6. I'm very excited to share that we generated positive free cash flow in our therapy selection business in the first quarter, supported by continuing improvement in Guardant360 ASPs. We had another significant step-up in Guardant360 reimbursement, reflecting the new crosswalk rate for Guardant360 LBT that took effect on January 1.

更仔細地查看幻燈片 6 中我們的治療選擇業務中最近的一些亮點。我很高興與大家分享，在 Guardant360 ASP 持續改進的支持下，我們的治療選擇業務在第一季度產生了正的自由現金流。我們在 Guardant360 報銷方面又取得了重大進展，這反映了 1 月 1 日生效的 Guardant360 LBT 的新人行橫道費率。

This increased the Medicare rate for Guardant360 LBT to $5,000. We also saw significant revenue upside from recent commercial payer coverage wins and believe that this is a tailwind that will continue to play out over the course of the year.

這將 Guardant360 LBT 的 Medicare 費率提高至 5,000 美元。我們也看到最近商業支付覆蓋範圍的勝利帶來了顯著的收入成長，並相信這是一個將在今年繼續發揮作用的推動力。

We also saw continued progress in our EMR integration efforts with streamline orders and workflows for physicians, notably more than one-third of orders in the first quarter were digital showing the effectiveness of the integration process.

我們也看到我們的 EMR 整合工作不斷取得進展，簡化了醫生的訂單和工作流程，特別是第一季超過三分之一的訂單都是數位化的，顯示了整合流程的有效性。

We had strong growth in the quarter, driven by continued Guardant360 volume growth across all cancer types as well as contribution from Japan and the UK. At Guardant, high-quality science and data have always been the driving force in our mission to transform patient care. To that end, I'm excited to share that we recently reached a significant milestone and surpassed 500 peer-reviewed publications, highlighting the data produced by our innovative suite of products.

在所有癌症類型的 Guardant360 銷售持續成長以及日本和英國的貢獻的推動下，我們在本季度實現了強勁增長。在 Guardant，高品質的科學和數據始終是我們實現病患照護變革使命的驅動力。為此，我很高興地告訴大家，我們最近達到了一個重要的里程碑，同行評審出版物數量超過 500 份，突出顯示了我們的創新產品套件產生的數據。

Over the years we have deliberately made investments to develop tests based on cutting-edge science, and we are proud that conducted some of the largest and most impactful studies ever to be performed in our field.

多年來，我們刻意投資開發基於尖端科學的測試，我們很自豪能夠進行一些我們領域有史以來規模最大、最具影響力的研究。

This incredible breadth of data demonstrates the impact our technology has on both patients and the scientific community in order to improve patient outcomes and ultimately give us all more time free from cancer. We are committed to generating evidence that supports the real-world impact of our technology and its impact on patient outcomes. This will drive physician demand and favorable reimbursement as we continue to improve payer coverage, which will in turn expand volume and increase our ASPs.

這些令人難以置信的廣泛數據證明了我們的技術對患者和科學界的影響，以改善患者的治療結果，並最終讓我們所有人有更多時間遠離癌症。我們致力於產生證據來支持我們的技術對現實世界的影響及其對患者治療結果的影響。隨著我們繼續提高付款人的覆蓋範圍，這將推動醫生的需求和有利的報銷，從而擴大數量並提高我們的平均售價。

Now taking a closer look at our international progress on slide 7, we recently launched a new service at the Royal Marsden in England to test advanced non-small cell lung cancer patients using Guardant360. This partnership is supporting a new national pilot with NHS England that is integrating liquid biopsy testing into routine care much earlier in a patient's treatment journey.

現在仔細看看幻燈片 7 上我們的國際進展，我們最近在英國皇家馬斯登推出了一項新服務，使用 Guardant360 測試晚期非小細胞肺癌患者。此次合作正在支持英格蘭 NHS 的一項新的國家試點項目，該試點項目將液體活檢測試納入患者治療過程中更早期的常規護理中。

It allows patients with suspected non-small cell lung cancer to receive a CCP blood test concurrent with their diagnostic CT scan, so they may benefit from even earlier biomarker identification and subsequent targeted treatment.

它允許疑似非小細胞肺癌患者在進行診斷性 CT 掃描的同時接受 CCP 血液檢測，因此他們可能受益於更早的生物標記識別和隨後的標靶治療。

We are excited about this program demonstrating the value of bringing liquid biopsy testing much earlier into the patient journey to improve outcomes. The NHS study has already enabled more than 2000 patients with suspected advanced lung cancer to receive a CCP blood test from current with the diagnostic scan and is set to expand to an additional 10,000 patients by next March.

我們對該計劃感到興奮，該計劃展示了更早地將液體活檢測試引入患者旅程以改善結果的價值。NHS 的研究已經使 2000 多名疑似晚期肺癌患者能夠透過診斷掃描接受 CCP 血液檢測，並計劃在明年 3 月之前擴大到另外 10,000 名患者。

Moving on to slide 8. At our Investor Day last fall, we shared an exciting vision for our smart liquid biopsy platform, which is enabling first-of-its-kind capabilities across a myriad of applications. Last month, we presented exciting methylation fuel data for a few of these applications at the ACR Annual Meeting, highlighting the value of the Guardant Infinity epigenome mixed signal to generate novel insights.

繼續看投影片 8。在去年秋天的投資者日上，我們分享了我們的智慧液體活檢平台的令人興奮的願景，該平台在眾多應用程式中實現了同類首創的功能。上個月，我們在 ACR 年會上展示了其中一些應用的令人興奮的甲基化燃料數據，強調了 Guardant Infinity 表觀基因組混合訊號在產生新穎見解方面的價值。

This data shows how smart liquid biopsy technology provides information and not only boosting sensitivity for important drug classes such as targeted therapies and immunotherapies, but forgiving unprecedented biological insight into the patient's cancer and their health as a whole.

這些數據顯示了智慧液體活檢技術如何提供訊息，不僅提高標靶治療和免疫療法等重要藥物類別的敏感性，而且對患者的癌症及其整體健康狀況提供前所未有的生物學洞察。

For example, we presented data that demonstrated that we could do more than just attack the tumor tissue of origin blood by unlocking the specific tumor histological subtype, which is critical given patients can often fail therapy due to transformation of the tumor subtype.

例如，我們提供的數據表明，我們不僅可以透過解鎖特定的腫瘤組織學亞型來攻擊起源血液的腫瘤組織，這一點至關重要，因為患者通常會因腫瘤亞型的轉變而導致治療失敗。

And today, these transformations are often difficult to detect even in tissue. Just as exciting, we presented data showing that we can predict adverse cardiac events in patients in HER2-directed therapy, including the deductibility of hard risks and damage months prior to drug-induced heart failure. These are just a handful of the profound applications that are a smart liquid biopsy platform will enable setting a new bar for what physicians will expect from their testing partner.

如今，即使在組織中，這些轉變通常很難被偵測到。同樣令人興奮的是，我們提供的數據表明，我們可以預測 HER2 導向治療患者的不良心臟事件，包括在藥物引起的心臟衰竭前幾個月可扣除硬風險和損害。這些只是智慧液體活檢平台的一些深刻應用，它將為醫生對測試合作夥伴的期望設定新的標準。

Now shifting gears to reveal on slide 9, where we are the leader in tissue free MRD. I'm excited to share that our COSMOS CRC data from our COSMOS colon study, looking at Stage 2 and 3 patients has been submitted for publication and is under review at a peer-reviewed journal.

現在，我們將在幻燈片 9 上展示我們是無組織 MRD 領域的領導者。我很高興與大家分享，我們針對 2 期和 3 期患者的 COSMOS 結腸研究的 COSMOS CRC 數據已提交發表，並正在同行評審期刊上接受審查。

Looking ahead to the remainder of the year, we anticipate publication that will support submissions to Medicare for potential additional coverage in colon and breast cancers. Next year, we have important clinical validity studies for additional cancers such as lung, pancreatic and gastric head will support advancement of additional reimbursement.

展望今年剩餘時間，我們預計將有出版物支持向醫療保險提交潛在的結腸癌和乳腺癌額外承保範圍。明年，我們將對肺癌、胰臟癌和胃頭癌等其他癌症進行重要的臨床有效性研究，這將支持額外報銷的進展。

We are excited by the demand we are seeing in the market, fueled by the fact that are greater than 12 million cancer survivors more than five years out from surgery, a tissue free MRD solutions such as Reveal will be key to addressing the significant market.

我們對市場上看到的需求感到興奮，超過 1,200 萬名癌症倖存者距離手術還有五年多的時間，像 Reveal 這樣的無組織 MRD 解決方案將成為解決這一重要市場的關鍵。

That said, we are not only the clear leader in this enormous market segment, but the only tissue free MRD option in the market today. Despite our excitement, we believe it is important at this time to manage volumes very closely and hence minimize cash burn until the Reveal is gross margin positive.

也就是說，我們不僅是這個龐大市場領域的明顯領導者，而且是當今市場上唯一的無組織 MRD 選擇。儘管我們很興奮，但我們認為，目前重要的是密切管理銷量，從而最大限度地減少現金消耗，直到毛利率為正。

Even ahead of additional Medicare reimbursement, with the impact of biomarker bills, we are starting to see improvements with the Reveal ASPs. 17 states have now passed biomarker bills with several other states on deck for possible investment this year. We are still early in the process, but starting to see some tailwinds that will bode well for future commercial coverage of our tests.

即使在額外的醫療保險報銷之前，由於生物標記帳單的影響，我們也開始看到 Reveal ASP 的改進。目前已有 17 個州通過了生物標記法案，其他幾個州也準備在今年進行可能的投資。我們仍處於這個過程的早期階段，但開始看到一些有利因素，這對我們測試的未來商業覆蓋來說是個好兆頭。

We are also making very good progress in our COGS reduction initiatives for appeal. As a result, we expect that with significant lower COGS and with improved ASPs where they will be gross margin positive in 2025. This will be an important milestone in minimizing MRD cash burn and enable us to gradually accelerate volume expansion.

我們在呼籲減少銷售成本的措施方面也取得了非常好的進展。因此，我們預計，隨著銷貨成本顯著降低和平均售價提高，到 2025 年毛利率將為正值。這將是最大限度減少 MRD 現金消耗的一個重要里程碑，並使我們能夠逐步加速銷售擴張。

Furthermore, over the long term, we are confident we can achieve greater than 60% gross margins for our MRD business. On April 29, the FDA issued its final ruling related to the planned oversight of LDTs. While our regulatory team continues to work through the details of the rule is consistent with our expectations. The rule outline an exemption from premarket review for tests approved by New York State given the fact that our key test our New York State approved, we would expect this exemption to allow us to continue to operate largely as we did now.

此外，從長遠來看，我們有信心 MRD 業務的毛利率能夠達到 60% 以上。4 月 29 日，FDA 發布了有關 LDT 計畫監管的最終裁決。雖然我們的監管團隊繼續研究該規則的細節，但與我們的預期是一致的。該規則概述了紐約州批准的測試的上市前審查豁免，因為我們的關鍵測試得到了紐約州的批准，我們預計這項豁免將使我們能夠繼續像現在一樣運作。

As a reminder, Guardant360 CDx was the first FDA-approved liquid biopsy test for CGP across solid tumors. Our proven track record with FDA positions us to continue to offer high quality tests when the final rule goes into effect. We look forward to the follow on FDA guidance, documents to help clarify the nuanced aspects of the final group.

需要提醒的是，Guardant360 CDx 是 FDA 批准的第一個針對實體瘤 CGP 的液體活檢測試。我們在 FDA 的良好記錄使我們能夠在最終規則生效後繼續提供高品質的測試。我們期待後續 FDA 的指導和文件，以幫助澄清最終小組的細微差別。

With that, I will now turn the call over to AmirAli for an update on screening.

現在，我將把電話轉給阿米爾阿里，以了解篩檢的最新情況。

Thanbks Helmy. We are making remarkable strides with our shield blood test as we lead the way in establishing a new category within the CRC screening market. Shield continues to be the best in class blood test with significant first mover advantage and at this time, we do not see any credible competitor in our line of sight.

謝謝赫爾米。隨著我們在結直腸癌篩檢市場中建立新類別的領先地位，我們的盾牌血液檢測取得了顯著的進展。Shield 仍然是同類中最好的血液測試，具有顯著的先發優勢，目前，我們在我們的視線中沒有看到任何可信賴的競爭對手。

Turning to slide 10, since our last earnings call, the data from our pivotal equip study was published in the New England Journal of Medicine, the world's leading peer reviewed medical journal. This publication was a major milestone for Shield and a strong endorsement of the quality of the clinical data. This data meets the benchmark for Medicare reimbursement, positioning us to potentially become the first FDA approved Medicare reimbursed CRC screening blood tests.

轉向投影片 10，自我們上次財報電話會議以來，我們的關鍵設備研究的數據已發表在世界領先的同行評審醫學期刊《新英格蘭醫學雜誌》上。該出版物是 Shield 的一個重要里程碑，也是對臨床數據品質的有力認可。這些數據符合醫療保險報銷的基準，使我們有可能成為 FDA 批准的第一個醫療保險報銷的 CRC 篩檢血液檢測。

Turning to slide 11. Following a publication in the New England Journal of Medicine. We were very excited to see such an enthusiastic response from media, consumer advocacy groups and opinion leaders with attention from outlets such as the Associated Press and PR, The New York Times Colon Cancer Coalition and many others they interest in potential value of this blood test is evident. Many recognize the significance of this publication as it brings us one step closer to providing a new choice for patients and helping to close the screening gap.

轉到投影片 11。在《新英格蘭醫學雜誌》發表文章後。我們很高興看到媒體、消費者權益團體和意見領袖如此熱烈的反應，並受到美聯社和公關、紐約時報結腸癌聯盟以及許多其他對這項血液測試的潛在價值感興趣的媒體的關注顯而易見。許多人認識到這份出版物的重要性，因為它使我們離為患者提供新選擇並幫助縮小篩檢差距又近了一步。

Moving on to slide 12, our interactive review process with FDA continues to be collaborative and positive, and we continue to make steady progress. The advisory committee panel meeting will be the next milestone that the review process and will take place on May 23. Our team has worked incredibly hard to get ready, and we are well prepared for this panel meeting.

轉到投影片 12，我們與 FDA 的互動審查流程繼續保持協作和積極，並且我們繼續取得穩步進展。諮詢委員會小組會議將是審查過程的下一個里程碑，將於 5 月 23 日舉行。我們的團隊為準備工作付出了極大的努力，我們為這次小組會議做好了充分的準備。

In parallel, we are eagerly anticipating the launch of Shield IVD in 2024 shortly after expected FDA approval. Armed with two years of commercial experience from Shield IVD, we have fine-tuned our operations, including enhancements of customer experience, seamless digital ordering and access to national phlebotomy networks. After years of research and development, it's so exciting to prepare to make this test broadly available.

同時，我們熱切期待 Shield IVD 在預計獲得 FDA 批准後不久於 2024 年推出。憑藉 Shield IVD 兩年的商業經驗，我們對我們的營運進行了微調，包括增強客戶體驗、無縫數位訂購和存取國家靜脈放血網路。經過多年的研究和開發，準備廣泛使用這項測試真是令人興奮。

Turning to slide 13, there are 120 million average-risk individuals between the age of 45 to 84, which includes 50 million unscreened individuals. Approximately 75% of CRC related deaths occur within this unscreened population, and this is with having a broad menu of stool-based test available for over a decade.

轉向投影片 13，年齡在 45 歲至 84 歲之間的平均風險族群有 1.2 億，其中包括 5,000 萬未經篩檢的族群。大約 75% 的 CRC 相關死亡發生在這群未經篩檢的族群中，這是因為十多年來已有廣泛的糞便檢測。

We believe that reaching this group is the most important opportunity to transform the CRC screening paradigm and the real-world evidence clearly shows that the multimodality is best positioned to capture the on-screen opportunity.

我們相信，接觸這群人是改變 CRC 篩檢範式最重要的機會，而現實世界的證據清楚地表明，多模態最適合抓住篩檢機會。

We believe screening these 50 million individuals is addressable by a blood test because nearly 87% of people aged 50 and above have been seeing their doctor during the last 12 months based on findings from an annual national health interview survey.

我們認為，透過血液檢測可以對這 5000 萬人進行篩檢，因為根據年度全國健康訪談調查的結果，近 87% 的 50 歲及以上人群在過去 12 個月內一直在看醫生。

Interestingly, 91% of that group has had a blood draw in the last 12 months. This tells us that the majority of the unscreened population is, in fact, engage with the health care system and routinely getting blood draws, making a blood-based CRC screening test an obvious fit and their existing care.

有趣的是，該群體中 91% 的人在過去 12 個月內抽血。這告訴我們，事實上，大多數未經篩檢的人群都參與了醫療保健系統並定期抽血，這使得基於血液的結直腸癌篩檢測試明顯適合他們現有的護理。

More importantly, our real-world LDT experience with Shield for over 20,000 tests over the past two years confirms that PCPs are enthusiastically ordering this test and when they do patients complete the test. We are content to send incredibly strong adherence rates of more than 90% for Shield LBT.

更重要的是，我們在過去兩年中使用 Shield 進行了超過 20,000 次測試的真實 LDT 經驗證實，PCP 正在熱情地訂購這項測試，並且當他們讓患者完成測試時。我們很高興看到 Shield LBT 的遵守率高達 90% 以上。

Moving on to slide 14, a randomized prospective study results from Kaiser Permanente showed significant improvement in CRC screening rates when participants had a choice of a Shield test alongside other standard of care modalities. Through telephonic outreach to more than 2000 previously unscreened individuals participants were randomized into two groups.

轉到投影片 14，Kaiser Permanente 的一項隨機前瞻性研究結果顯示，當參與者選擇 Shield 測試和其他標準護理方式時，CRC 篩檢率顯著提高。透過電話聯繫 2000 多名之前未經篩選的個人，參與者被隨機分為兩組。

One group was offered offered citro-colonoscopy and the second group was given the added option of Shield. This study demonstrated that screening compliance significantly increased by nearly triple when the many of screening options was expanded to include the blood tests.

一組接受了大腸鏡檢查，第二組則接受了 Shield 的附加選項。這項研究表明，當許多篩檢選項擴大到包括血液檢測時，篩檢依從性顯著增加了近三倍。

This shows that lot has the opportunity to dramatically increase the screening rate at levels that exceeded even our initial expectations. We have time to answer the very excited about the near term opportunity for shield to transform the CRC screening paradigm and eventually to address the broader cancer screening landscape with the addition of more tumor types to our shield assay.

這表明該批次有機會大幅提高篩檢率，其水平甚至超出了我們最初的預期。我們有時間來回答令人興奮的問題，即 Shield 近期有機會改變 CRC 篩檢模式，並最終透過在我們的 Shield 檢測中添加更多腫瘤類型來解決更廣泛的癌症篩檢問題。

With that, I will now turn the call to Mike for more detail on our financials.

現在，我將致電麥克，以了解有關我們財務狀況的更多詳細資訊。

Thanks Amirali. Turning to slide 15. I'll start by reviewing our financial results for Q1 2024 all growth rates provided will be on a year-over-year basis unless otherwise noted.

謝謝阿米拉利。轉到投影片 15。首先，我將回顧 2024 年第一季的財務業績，除非另有說明，否則提供的所有成長率都將按年計算。

Total revenue grew 31% to $168.5 million, driven by very strong precision oncology testing revenue, which increased 38% to $156.2 million due to significant growth in both clinical and biopharma revenue. Precision oncology revenue from clinical tests increased 37% to $125.7 million. We were very pleased with our first quarter clinical test volume, which grew 20% to 46,900 tests in line with our expectations.

在非常強勁的精準腫瘤學測試收入的推動下，總收入增長了 31% 至 1.685 億美元，由於臨床和生物製藥收入的顯著增長，該收入增長了 38% 至 1.562 億美元。來自臨床測試的精準腫瘤學收入成長了 37%，達到 1.257 億美元。我們對第一季的臨床測試量感到非常滿意，成長了 20%，達到 46,900 次測試，符合我們的預期。

Guardant360, we saw solid year-over-year volume growth across all countries in the US as well as volume contribution from Japan and the UK. We also saw continued strong volume growth for both reveal and tissue mix. Precision oncology revenue from biopharma test in the first quarter totaled $30.5 million, up 40%. Biopharma test volume was particularly strong totaling 8,450 tests of 37% which reflects the strong pipeline we entered the year with.

Guardant360，我們看到美國所有國家的銷售量較去年同期穩健成長，以及日本和英國的銷售貢獻。我們也看到揭露和組織混合的銷售持續強勁成長。第一季來自生物製藥測試的精準腫瘤學收入總計 3,050 萬美元，成長 40%。生物製藥測試量尤其強勁，總計 8,450 次測試，佔 37%，這反映了我們進入今年的強大管道。

We continue to expect our biopharma business to perform well and conservatively forecast biopharma revenue to grow in the low teens for the full year 2024 with potential upside, assuming no adverse change in the biopharma macro environment. Finally, development services and other revenue was in line with our expectations and totaled $12.3 million.

我們繼續預期我們的生物製藥業務將表現良好，並保守預測，假設生物製藥宏觀環境沒有不利變化，2024 年全年生物製藥收入將在十幾歲左右增長，並具有潛在的上升空間。最後，開發服務和其他收入符合我們的預期，總計 1,230 萬美元。

Turning to slide 16, since mid-2023, we've seen consistent improvements to clinical reimbursement and ASP and have added incredibly strong start for the year. Firstly, on January 1, our Guardant360 LDT Medicare rate increase to $5,000 following the CMS crosswalk review process last year. Secondly, we are now seeing the impact of the Guardant360 commercial coverage wins we had in 2023.

轉向幻燈片 16，自 2023 年中期以來，我們看到臨床報銷和 ASP 持續改善，並為今年帶來了令人難以置信的強勁開局。首先，繼去年 CMS 人行橫道審核流程之後，我們的 Guardant360 LDT 醫療保險費率於 1 月 1 日上漲至 5,000 美元。其次，我們現在看到了 2023 年 Guardant360 商業覆蓋勝利的影響。

In Q1 2024, cash collected for tests performed last year was significantly higher than we had previously accrued, which resulted in an approximate $8 million revenue upside in the quarter. In addition, due to the improved commercial reimbursement trend, we increased our Guardant360 ASP for Q1 to be in the range of $2,900 to $2,950, which is higher than the forecasted range of $2,850 to $2,900. We expect the Guardant360 ASP for the full year will be in this new higher range.

2024 年第一季度，去年進行的測試所收集的現金明顯高於我們先前應計的金額，這導致該季度的收入增加了約 800 萬美元。此外，由於商業報銷趨勢改善，我們將第一季的 Guardant360 平均售價提高到 2,900 美元至 2,950 美元，高於預測的 2,850 美元至 2,900 美元。我們預計 Guardant360 全年的 ASP 將處於這個新的更高範圍內。

Finally, we also received better than expected commercial reimbursement for reveal TissueNext and Response in the first quarter of 2024. While we still need to see a more consistent reimbursement trends for these tests, the reinvestment received in Q1 points to potentialize the upside in future quarters. Although it's still early days, we feel we are on track to achieve the long-term ASP targets we presented at our Investor Day earlier than originally anticipated. This year we achieved our top line targets, as well as potentially to bring forward our timeline to reach company-wide cash flow breakeven.

最後，我們也因在 2024 年第一季揭露 TissueNext 和 Response 而獲得了好於預期的商業補償。雖然我們仍然需要看到這些測試更一致的報銷趨勢，但第一季收到的再投資顯示未來幾季的上漲潛力。儘管現在還處於早期階段，但我們認為我們預計將比最初預期更早實現我們在投資者日上提出的長期平均售價目標。今年，我們實現了營收目標，並有可能提前實現全公司現金流損益平衡的時間表。

Moving on to non-GAAP financial measures on slide 17. Our non-GAAP gross margin, excluding screening, which reflects our therapy selection and MRD businesses, was 64% in the first quarter of 2024, an improvement compared to 63% in Q1 2023.

接下來討論投影片 17 上的非 GAAP 財務指標。2024 年第一季度，我們的非 GAAP 毛利率（不包括篩檢）（反映了我們的治療選擇和 MRD 業務）為 64%，比 2023 年第一季的 63% 有所改善。

As Helmy mentioned, we are carefully managing Reveal test volume ahead of broad reimbursement as it currently carries a negative gross margin. Even with a larger proportion of field tests in Q1 2024 compared to Q1 2023, we were able to improve our non GAAP gross margin driven by strong governance we seek to address these on reimbursement we received in the first quarter of 2024.

正如 Helmy 所提到的，我們正在廣泛報銷之前仔細管理 Reveal 測試量，因為它目前的毛利率為負。儘管與2023 年第一季相比，2024 年第一季的現場測試比例更大，但在強有力的治理推動下，我們仍能夠提高非GAAP 毛利率，我們力求透過2024 年第一季收到的報銷來解決這些問題。

Non-GAAP operating expenses were $176.5 million, a reduction of $11.8 million compared to the prior year quarter. This decrease was primarily driven by lower clinical study costs following the completion of eclipse enrollment in Q3 last year. With increased revenue, improved gross margins and lower operating expenses, our adjusted EBITDA improved significantly from a loss of $101.0 million in Q1 2023 to a loss of $61.1 million in Q1 2024.

非 GAAP 營運費用為 1.765 億美元，比去年同期減少 1,180 萬美元。這一下降主要是由於去年第三季 eclipse 入組完成後臨床研究成本降低。隨著營收的增加、毛利率的提高和營運費用的降低，我們調整後的 EBITDA 大幅改善，從 2023 年第一季的虧損 1.01 億美元增至 2024 年第一季的虧損 6,110 萬美元。

Moving on to slide 18 cash [burn], free cash flow for the first quarter of 2024 was negative $37 million, which improved significantly year over year compared to negative $82 million in Q1 2023. As you've seen from the slide, we have revised our free cash flow guidance for the full year 2024 to be in the range of negative $275 million to $285 million, which represents an improvement of $60 million to $70 million compared to 2023.

接下來看投影片 18 現金[燒錢]，2024 年第一季的自由現金流為負 3,700 萬美元，與 2023 年第一季的負 8,200 萬美元相比，年比顯著改善。正如您從幻燈片中看到的，我們已將2024 年全年自由現金流指引修改為負2.75 億美元至2.85 億美元範圍內，這意味著與2023 年相比增加了6000 萬美元至7000 萬美元。

The key drivers of this revised 2024 guidance of the improved commercial reimbursement we are receiving for Guardant360 and a reduction in screening spend. As we've mentioned many times before, our screening spend will be gated by major milestones, the next milestone being FDA approval. While we continue to expect FDA approval and commercial launch of shield in 2024 the delay to the advisory committee panel meeting means that we've revised our operating plan and as a result now expect maximum screening cash burn this year to be $175 million lower than our previously stated $200 million.

修訂後的 2024 年指南的主要驅動因素是我們收到的 Guardant360 商業報銷的改善和篩選支出的減少。正如我們之前多次提到的，我們的篩選支出將受到主要里程碑的限制，下一個里程碑是 FDA 的批准。雖然我們仍然預計 Shield 將於 2024 年獲得 FDA 批准和商業推出，但諮詢委員會小組會議的推遲意味著我們已經修改了營運計劃，因此現在預計今年的最大篩選現金消耗將比我們的預期低 1.75 億美元此前曾表示2億美元。

On this slide, we've also included a breakdown of the screening cash burn for full year 2024 to provide additional color on the level of investments we're making in screening. As you can see as well as SG&A expense, we're incurring costs and a gross loss driven shield tax products and Medicare reimbursement coverage and we are continuing to invest in screening research and development, including our Shield lung clinical study, making technology and automation improvements and continuing to make progress in multi-cancer early detection development.

在這張投影片中，我們也詳細列出了 2024 年全年的放映現金消耗情況，以進一步說明我們在放映方面的投資水準。正如您所看到的，除了SG&A 費用外，我們還產生成本和毛損失驅動的盾稅產品和醫療保險報銷範圍，我們將繼續投資於篩選研究和開發，包括我們的盾肺臨床研究、製造技術和自動化改進並繼續在多癌症早期檢測開發方面取得進展。

We expect the screening cash burn profile to change in 2025 as the gross loss will become a gross profit following ADLT reimbursement and our shield lung clinical study expense will reduce significantly once enrollment is completed. This will enable us to increase the investment in our commercial operations while not exceeding a maximum net burn for screening of 200 million per year.

我們預計篩檢現金消耗狀況將在 2025 年發生變化，因為在 ADLT 報銷後，總損失將變成毛利，一旦入組完成，我們的盾肺臨床研究費用將顯著減少。這將使我們能夠增加對商業營運的投資，同時每年放映的淨消耗上限不超過 2 億。

As we look ahead to the next few years, we're confident that by continuing to generate positive cash flow from focused selection, driving MRB to profitability and carefully managing the investment into screening, we can continue to lower our cash burn this year so that we reach cash flow breakeven by 2028 or potentially earlier, which is achievable with our current cash balance of $1.1 billion.

展望未來幾年，我們相信，透過繼續透過集中選擇產生正現金流、推動 MRB 盈利並謹慎管理篩選投資，我們可以繼續降低今年的現金消耗，以便我們到2028 年或更早實現現金流收支平衡，這在我們目前11 億美元的現金餘額中是可以實現的。

Now turning to our outlook and assumptions for the full year 2024 on slide 19. We're pleased to be able to make improvements across all guidance metrics. We now expect full year 2024 revenue to be in the range of $675 million to $685 million, representing growth of approximately 20% to 21% compared to 2023. This increase was primarily due to the commercial reimbursement outflows we had in the first quarter and the increasing Guardant360 ASP that we expect for the remainder of the year.

現在轉向幻燈片 19 上我們對 2024 年全年的展望和假設。我們很高興能夠改善所有指導指標。我們目前預計 2024 年全年營收將在 6.75 億至 6.85 億美元之間，較 2023 年成長約 20% 至 21%。這一增長主要是由於我們在第一季的商業報銷流出以及我們預計今年剩餘時間內 Guardant360 ASP 的增加。

As a reminder, this guidance does not include any revenue contribution from screening, which are dependent on the timing to Shield FDA approval and Medicare reimbursement coverage. We'll update our revenue guidance streams through screening revenue when appropriate.

提醒一下，本指南不包括篩檢帶來的任何收入貢獻，這取決於 Shield FDA 批准的時間和醫療保險報銷範圍。我們將在適當的時候透過篩選收入來更新我們的收入指導流。

We expect non-GAAP gross margin, excluding screening to be in the range of 61% to 63%, an improvement from our previous guidance of 60% to 62%. Again, this is due to improved clinical commercial reimbursement. We've lowered our non-GAAP operating expenses to be in the range of $720 million to $730 million, representing a flat to 1% year-over-year decline. This decrease is due to the reduction in screening operating expenses, as I just outlined.

我們預計非 GAAP 毛利率（不包括篩檢）將在 61% 至 63% 之間，較我們先前 60% 至 62% 的指導有所改善。同樣，這是由於臨床商業報銷的改善。我們已將非 GAAP 營運費用降低至 7.2 億美元至 7.3 億美元之間，年減 1%。正如我剛才概述的那樣，這種減少是由於篩檢營運費用的減少。

Finally, as previously mentioned, we expect free cash flow to be in the range of negative $275 million to $285 million in 2024.

最後，如前所述，我們預計 2024 年自由現金流將在負 2.75 億美元至 2.85 億美元之間。

Finally, turning to slide 20 to review our catalysts. As we look ahead to the rest of 2024 and beyond, we have a number of upcoming milestones in each of our key business areas, including the smart liquid biopsy upgrade for directory 16 therapy selection, data publications and Mosaic submission for MRD and Shield FDA approval in March.

最後，轉向幻燈片 20 回顧我們的催化劑。展望 2024 年剩餘時間及以後，我們的每個關鍵業務領域都有許多即將到來的里程碑，包括目錄 16 療法選擇的智能液體活檢升級、數據發布以及 MRD 和 Shield FDA 批准的 Mosaic 提交三月。

With that, we'll now open the call to questions.

現在，我們將開始提問。

Thank you. We will now begin the question and answer portion of the call. (Operator Instructions)

謝謝。我們現在將開始電話的問答部分。（操作員說明）

Mark Massaro, BTIG .

馬克·馬薩羅，BTIG。

Hey, guys. Congratulations on the strong beat and raise. To limit myself to one question, obviously, we're two weeks away from the FDA AdCom. I think a lot of people are expecting the conversation to focus on the safety and efficacy as well as some of the other benefits of Shield like the patient compliance or patient adherence.

大家好。恭喜您獲得強勁的擊敗和加註。顯然，我只想問一個問題，距離 FDA AdCom 批准還有兩週。我認為很多人都希望對話重點關注 Shield 的安全性和有效性以及 Shield 的其他一些好處，例如患者依從性或患者依從性。

But I think there are some questions in the investor community that are focusing on the labeling and the topic of advanced adenomas. Do you guys have a sense for whether or not you think a label conversation will be much of a focus of this of this meeting and how are you thinking about on the setup and the tone of questions ahead.

但我認為投資人界存在一些問題，重點是晚期腺瘤的標籤和主題。你們是否知道廠牌對話是否會成為本次會議的重點？

Yes thank you Mark. We are excited to get to this point of the review process in terms of the top agenda, all those matters. Actually, it's gated published by agency a couple of those prior to the meeting, and we are just two weeks away from that. So both of those materials when they put it in the federal registry and become public provide some more detail inside that part of your question.

是的，謝謝馬克。我們很高興能夠在所有這些事項的首要議程方面進入審查流程的這一階段。事實上，它已經在會議之前由幾個機構發布了，距離我們只有兩週的時間了。因此，當這些材料放入聯邦登記處並公開時，它們在您的問題的這一部分中提供了更多細節。

And we are going to that meeting with high confidence about the quality of this study that we've done quality of the device performance that we reported and published and our team has been working very hard to get ready to get to this point and go through this spend now and we are excited to see how that conversation would go.

我們對這項研究的質量充滿信心地參加了這次會議，我們已經完成了我們報告和發布的設備性能的質量，我們的團隊一直在非常努力地準備達到這一點並通過現在我們很高興看到這次對話將如何進行。

Thank you.

謝謝。

Jack Meehan, Nephron Research.

傑克·米漢，腎單位研究。

Thank you. Good afternoon. Want to focus onGuardant360 here. I have two questions. The first is on ASP. So $2,900 and $2,950, I think that was about $50 better than you were guiding. I was curious if there was anything that stood out there or if it was kind of everything tracking the right way.

謝謝。午安.這裡想重點關注Guardant360。我有兩個問題。第一個是 ASP。所以 2,900 美元和 2,950 美元，我認為比您指導的要好 50 美元左右。我很好奇是否有什麼東西突出在那裡，或者是否一切都以正確的方式進行。

And then on the volume side, I was wondering if you can peel back some of the drivers to start the year. Are there any cancer indications that stood out and just how you're feeling about the durability of growth?

然後在數量方面，我想知道你是否可以在今年開始時剝離一些驅動因素。是否有任何明顯的癌症跡像以及您對生長持久性的感受如何？

Thank you. Yes, I can start on that. On the ASP. Jack I think we have -- we had really strong ASP and commercial reimbursement in the quarter. So really pleased that we knew we were going to get the uplift from the many medical increased to Guardant360 LDT up, but we also saw really strong reimbursement and payments from commercial payers, not just for Guardant360, but also across all of our portfolio. So that had a really positive impact on our ASP.

謝謝。是的，我可以從那裡開始。在 ASP 上。傑克，我認為我們在本季的平均售價和商業報銷非常強勁。非常高興的是，我們知道我們將從 Guardant360 LDT 的許多醫療費用增加中獲得提升，但我們也看到來自商業付款人的真正強勁的報銷和付款，不僅針對 Guardant360，而且針對我們所有的投資組合。這對我們的 ASP 產生了非常正面的影響。

And yes, as we said in the prepared remarks, we've now increased our expected Guardant360 ASP to the range to $2,900 to $2,950. So you're right, it's about a raised of $50 per test increased. And we also said in his prepared remarks, we had approximately $8 million upside in Q1, and that was related to commercial reimbursement that we received in the quarter. That was really out of period service for tests performed in the second half of last year.

是的，正如我們在準備好的評論中所說，我們現在已將 Guardant360 的預期 ASP 提高到 2,900 美元至 2,950 美元。所以你是對的，每次測試增加大約 50 美元。我們還在他準備好的演講中表示，我們在第一季有大約 800 萬美元的上漲空間，這與我們在本季收到的商業報銷有關。對於去年下半年進行的測試來說，這確實已經超出了服務期限。

So but even if you strip that $8 million out in a still really strong ASP performance and then increase that we now think Guardant360 will flow through for the rest of the year. And some of the volume and I think it was it said in the prepared remarks, we saw really growth across really all indications for Guardant360. We saw growth in terms of both breadth and depth is I would say it was obviously a bigger percentage of the growth given that essentially how widespread the Guardant360

因此，即使您在 ASP 性能仍然非常強勁的情況下扣除 800 萬美元，然後增加該金額，我們現在認為 Guardant360 仍將在今年餘下時間裡流通。我認為在準備好的演講中已經提到了一些數量，我們看到 Guardant360 的所有適應症都出現了真正的增長。我們看到了廣度和深度方面的成長，我想說，考慮到 Guardant360 的廣泛普及，這顯然是成長的更大比例。

But we've been very pleased with the start of the year. Obviously, we had a fantastic quarter and I think it bodes well, especially for their for the second half as some of our initiatives that are just getting started look to be really taking off in the right way international volumes are picking up. We have the NHS sort of engagement with the 10,000 lung cancer patients.

但我們對今年的年初感到非常滿意。顯然，我們度過了一個美好的季度，我認為這是個好兆頭，特別是對於下半年來說，因為我們剛開始的一些舉措看起來確實以正確的方式起飛，國際銷量正在回升。我們與 10,000 名肺癌患者進行了類似 NHS 的接觸。

And then all the EMR work we've been doing is really just getting started. We're seeing, I think, considerable increase in depth in those accounts as they start to getting engaged with our EMR integrations. And so we're picking up the pace of some of that and I think it's going to be really nice growth driver for the next couple of years.

我們一直在做的所有 EMR 工作實際上才剛剛開始。我認為，隨著這些客戶開始參與我們的 EMR 集成，我們看到這些客戶的深度顯著增加。因此，我們正在加快其中的步伐，我認為這將成為未來幾年非常好的成長動力。

Dan Arias, Stifel.

丹·阿里亞斯，斯蒂菲爾。

Afternoon, guys. Thanks for the questions here. Like, on MRD, what do you have as a revenue target for reveal at this point for 2024.

下午好，夥計們。感謝您在這裡提出的問題。例如，在 MRD 上，目前要透露的 2024 年營收目標是多少。

And then can you help me maybe talk to the extent to which you're holding back on reveal because of the cost headwinds that come out of that? Is it possible that you get to the point where you're opening up the spigot a bit and getting the test use becomes at least as important as safeguarding ASP and COGS, especially since it sounds like you're making some COGS improvement there.

然後你能幫我談談你因為由此產生的成本阻力而推遲透露的程度嗎？您是否有可能達到這樣的地步：稍微打開水龍頭，讓測試使用變得至少與保護 ASP 和 COGS 一樣重要，特別是因為聽起來您正在那裡進行一些 COGS 改進。

I can start on MRD revenue. We're not breaking that out for the 2024. We said last year that the revenue for reveal was in the sort of low double digit millions, and obviously, we expect it to grow this year where we are growing the volume and we are seeing nice traction with the ASP. So that revenue will grow. But I think we don't particularly want to be breaking out the revenue by all of the different products that are now mature

我可以從 MRD 收入開始。我們不會在 2024 年解決這個問題。我們去年說過，展示的收入在幾百萬左右，顯然，我們預計今年它會成長，我們正在增加銷量，我們看到了 ASP 的良好吸引力。這樣收入就會成長。但我認為我們並不是特別希望透過現在成熟的所有不同產品來細分收入

No, I mean, I think we see, I think, tremendous volume up there. As I said, in the prepared remarks, there are 12 million cancer survivors that are five years out from surgery. And so there really are a untapped population. We're seeing so much demand latent demand out there, especially in that population. And there really are no tests that are suitable for them. Today are really the major sort of impediment to getting that. Our volume has really been the kind of sort of where its peers are and where the causes and all of that will likely be a much, much improved once we get the surveillance CRC indication and once we're through some of these COGS reduction initiatives.

不，我的意思是，我認為我們看到了巨大的成交量。正如我在準備好的發言中所說，有 1200 萬癌症倖存者五年後就無法接受手術。所以確實存在尚未開發的人口。我們看到那裡有如此多的潛在需求，尤其是在這個人群中。而且確實沒有適合他們的測試。今天確實是實現這一目標的主要障礙。一旦我們獲得了 CRC 監測指標，並且一旦我們完成了其中一些 COGS 削減舉措，我們的銷量確實與同行的情況、原因以及所有這些都可能會大大改善。

And so we see the gross margin profile looking really, really nice. And in 2025 and beyond and once we're gross margin positive on will be taking in the government and often fairly I'm putting the pedal to the metal in terms of that volume on. And yes, we feel very good at it in terms of better positioning now in terms of where our volumes are. And so right now, we don't see a need to necessarily burn more cash.

因此，我們看到毛利率狀況看起來非常非常好。到 2025 年及以後，一旦我們的毛利率為正，我們就會吸收政府的力量，而且通常我會在銷售方面全力以赴。是的，我們感覺非常擅長，現在就我們的銷售而言，我們的定位更好了。因此，目前我們認為沒有必要燒掉更多現金。

Patrick Donnelly, Citi.

派崔克唐納利，花旗銀行。

Thanks for taking the questions. Helmy, maybe one on the critical volumes follow up there. A nice 20% growth from the quarter. Can you talk about what you're seeing there and just the volume expectations we work our way through the year? Certainly curious in terms of the MRD. impact. I know you guys are taking some volume while at the same time holding back a little bit, just given they're not not profitable volumes at the moment. So it would be great if you could just talk through the P&L and the balance of, again, just that clinical volume, what you saw in the quarter and the outlook as we go through the year?

感謝您提出問題。海爾米，也許是關鍵卷上的一本後續。較本季成長了 20%。您能談談您在那裡看到的情況以及我們全年的銷售預期嗎？當然對 MRD 感到好奇。影響。我知道你們在拿走一些交易量的同時又保留了一點，只是考慮到他們目前還沒有盈利。因此，如果您能只討論損益表以及臨床量、您在本季度看到的情況以及我們全年的前景的平衡，那就太好了？

No, I mean, we're very pleased with the start of the year in terms of our clinical volumes across the Board. We're seeing growth across all tumor types in our old product lines and so we're very pleased with where that's going. I think the mix is getting nice for us just in the sense. We're managing some of those are available volumes on and so like I think the major thing for us is I think some of the growth initiatives we have which are, as I said, EMR integrations, some of the international stuff.

不，我的意思是，我們對今年年初的全面臨床量感到非常滿意。我們看到舊產品線中所有腫瘤類型的成長，因此我們對這項進展感到非常滿意。我認為從某種意義上說，這種混合對我們來說越來越好。我們正在管理其中一些可用量，所以我認為對我們來說最重要的是我認為我們擁有的一些增長計劃是，正如我所說的，EMR 集成，一些國際化的東西。

And then I think what we're very excited about the I think second half of this year, the smart liquid biopsy transition. We are seeing that even before that we're doing really well in the market. Obviously, there's competition that ebbs and flows, but whereas dosing of the current products we have are really best in class from a sensitivity from a turnaround time and that is really the major differentiator in terms of what liquid biopsies need to do to save patients' lives.

然後我認為我們對今年下半年的智慧液體活檢轉型感到非常興奮。我們發現，甚至在此之前，我們在市場上的表現就非常好。顯然，競爭有起有落，但從週轉時間的敏感性來看，我們現有產品的劑量確實是同類中最好的，這確實是液體活檢需要採取哪些措施來拯救患者的主要區別因素。 。

But as we start transitioning to smart liquid biopsy, we've seen from the pharma demand that has been really exciting and really strong from the conversations we've had at ACR with some of the new data around smart liquid biopsy at the genomics.

但當我們開始向智慧液體活檢過渡時，我們從 ACR 上與基因組學智慧液體活檢相關的一些新數據進行的對話中看到，製藥需求非常令人興奮且非常強勁。

On that, we're really going to raise the bar considerably in terms of what physicians expect from their test in terms of the capabilities and doing things that are even difficult to do in tissue, as I highlighted in the call. And we think that is going to sort of sort of put us into sort of overdrive once all of that is out in the market, especially in tumor types on where is comprehensive genomic profiling really haven't hasn't been that useful outside of breast lung and colorectal and so we think genomics and smart liquid biopsy will sort of catalyze a lot of that volume that is still out there, still in its early innings.

在這一點上，正如我在電話中所強調的那樣，我們確實將大大提高醫生對測試的期望，即能力和做組織中難以做到的事情。我們認為，一旦所有這些都進入市場，特別是在腫瘤類型中，全面的基因組分析確實在乳腺以外的領域並沒有那麼有用，這會讓我們陷入某種超速狀態。我們認為基因組學和智慧液體活檢將在某種程度上催化大量仍然存在的、仍處於早期階段的數量。

Sung Ji Nam, Scotiabank.

宋志南，豐業銀行。

So this is Cory Rosenbaum for Sung Ji. Thanks for taking my questions. So one of your peers mentioned yesterday that the USPSTF update timing is more likely to come in 2027. Would you have additional insight into that and would the delay in timing there materially impact your commercial strategy for shield following FDA approval? Thanks

這是宋吉的科里·羅森鮑姆。感謝您回答我的問題。所以你的一位同行昨天提到 USPSTF 更新時間更有可能是在 2027 年。您對此有更多的了解嗎？謝謝

No actually we heard about that before and we tried to actually see if we can buy a car from Asia. In fact, USPSTF has given no indication that they're intending to delay there our process and it constantly and to thank Ken on their draft research plan. Our CRC screening should come out sometime this year.

不，實際上我們之前聽說過這一點，我們嘗試看看是否可以從亞洲購買汽車。事實上，USPSTF 並沒有表示他們打算不斷推遲我們的進程，並感謝 Ken 制定的研究計畫草案。我們的 CRC 篩檢應該會在今年某個時候推出。

In fact, if you look at their web site during last few weeks in a couple of near research draft wrap, a draft research plants got FOB published on their website, but we are manifest in mind for the field in terms of their road maps that we talked about in terms of our expansion , we are going to look at actually on site the milestones before we go to solve the expansions.

事實上，如果你在過去幾週查看他們的網站，在幾個近研究草案包裝中，研究工廠草案已在他們的網站上發布了 FOB，但我們清楚地看到該領域的路線圖我們談到了我們的擴展，在解決擴展之前，我們將在現場實際查看里程碑。

And one of the milestones for 2026 years are getting to the USPSTF guidelines I also want to maybe take the opportunity and notes to the importance of American Cancer Society guideline that we are expecting, hopefully sometime in 2025.

2026 年的里程碑之一是獲得 USPSTF 指南，我也想藉此機會指出我們期待的美國癌症協會指南的重要性，希望在 2025 年的某個時候。

That would be a good catalyst in this field, open up a bunch of additional adoption of this test and also reimbursement ASP stories in states that they have some state level mandates to cover CRC screening tests commented by ACS.

這將是該領域的一個良好催化劑，開啟更多對該測試的採用，並在各州報銷 ASP 故事，因為他們有一些州級授權來涵蓋 ACS 評論的 CRC 篩檢測試。

Sue Bernabe, Guggenheim.

蘇‧伯納貝，古根漢。

This is Brandon on for Subbu. In terms of therapy selection, we got some feedback that some competitors are offering a combination of immunohistochemistry or IHC. In addition to NGS capabilities for other markers besides PD-L1. You anticipate offering this kind of combined approach at the protein level with GuardantINFINITY ? And just any kind of general comments around the outlook there. Thanks.

這是代表蘇布的布蘭登。在治療選擇方面，我們得到一些回饋，一些競爭對手正在提供免疫組織化學或 IHC 的組合。除了 PD-L1 之外的其他標記物的 NGS 功能。您期望透過 GuardantINFINITY 在蛋白質層面上提供這種組合方法？以及有關前景的任何一般性評論。謝謝。

Yes, I mean, that is a difficult thing to add to the money out of something that was requested. And I think the exciting thing about INFINITY that works in blood. Obviously, I see the tissue test and what we can do with INFINITY in terms of some of the applications we're seeing or even difficult to do in tissue, frankly.

是的，我的意思是，從所要求的東西中添加錢是一件很困難的事情。我認為 INFINITY 令人興奮的一點是在血液中發揮作用。顯然，我看到了組織測試以及我們可以用 INFINITY 做些什麼，坦白說，我們看到的一些應用甚至在組織中很難做到。

And so we're -- what you're talking about is commodity things that anyone in the world can do. We're driving both breakthrough things that only Guardant can do in terms of what we're adding to the platform, but just like with added tissue that PDL1, we're going to add some of those base layers, if and when the market needs it. So fairly simple exercise.

所以我們——你所說的是世界上任何人都可以做的商品。我們正在推動兩項突破性的事情，就我們向平台添加的內容而言，只有 Guardant 才能做到，但就像 PDL1 中添加的組織一樣，如果市場出現這種情況，我們將添加其中一些基礎層需要它。所以相當簡單的練習。

Kyle Mikson, Canaccord Genuity.

凱爾米克森，Canaccord Genuity。

(Inaudible) Thanks for taking my call. So growth, obviously they will release their Form-10 and Form-10 kind of a build of a pretty extensive historical information regarding solid revenue growth over time. I'd like to move on one point here. Can you just discuss and decide the obvious multi-cancer versus single cancer? How you define yourself? You saw between these different multi-cancer testing Shield and also due to the gallery could is in a way a proof point that blood-based screening could in fact be successful on a wider scale. Thank you.

（聽不清楚）謝謝您接聽我的電話。因此，成長，顯然他們將發布 Form-10 和 Form-10 類型，其中包含有關隨著時間的推移穩定收入增長的相當廣泛的歷史資訊。我想在此談一點。您能討論並決定明顯的多種癌症與單一癌症嗎？你如何定義自己？您在這些不同的多種癌症檢測盾牌之間看到，並且由於圖庫可以在某種程度上證明基於血液的篩檢實際上可以在更廣泛的範圍內取得成功。謝謝。

Okay. So, it's hard to comment on other kind of companies 10-Q filing by in general, in terms of the landscape, scientifically, technologically, with a simple blood test we can do multi-cancer screening and early detection. But what we do believe is an entire pathway to make sure those innovation would be accessible for a wide set of population to really open up those markets.

好的。因此，一般來說，很難對其他類型的公司 10-Q 備案進行評論，從景觀、科學、技術角度來看，透過簡單的血液測試，我們就可以進行多種癌症篩檢和早期檢測。但我們確實相信，有一條完整的途徑可以確保廣大人群能夠獲得這些創新，從而真正打開這些市場​​。

And I think over time, we just got more confidence about our strategy to start with a single cancer like colon cancer that are pathways for approval, pathways for Medicare reimbursement, pathways for task force review, and then expand from that leading indication into other cancer types like we're doing a lung cancer screening study and we are working on some multi-cancer early detection kind of applications.

我認為隨著時間的推移，我們對我們的策略更有信心，從結腸癌等單一癌症開始，這是批准途徑、醫療保險報銷途徑、工作小組審查途徑，然後從該主要適應症擴展到其他癌症例如我們正在進行肺癌篩檢研究，我們正在研究一些多種癌症早期檢測類型的應用。

But CRC is going to be our really entrance and a pillar point of getting to this market and really making the test accessible. I think for other tests FDA had reimbursements -- there are many, many barriers and we'll see overtime how that strategy would pan out.

但 CRC 將成為我們進入這個市場並真正使測試可行的真正入口和支柱。我認為 FDA 對於其他測試有報銷——存在很多很多障礙，我們將隨著時間的推移看到該策略將如何實現。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hello, this is Yuko on the call for Tejas. Thank you for taking my questions. The recently finalized LBT regulation notes the FDA generally expect compliance with pre-market review for currently marketed LBTs if there are certain modifications that may affect to have basic safety and effectiveness profiles.

大家好，我是 Yuko，正在為 Tejas 通話。感謝您回答我的問題。最近最終確定的 LBT 法規指出，如果存在可能影響基本安全性和有效性的某些修改，FDA 通常希望目前上市的 LBT 能夠遵守上市前審查。

Given to us like G360 go through multiple versions improving performance overtime, would changes in algo constitute a modification under this finalized rule? And then quick follow-up. Also, as we think about future test development, would it be fair to same 100 or 200 bips headwind to medium term gross margin as the rules go into effect?

考慮到像G360這樣經過多個版本不斷提高效能，演算法的改變是否會構成最終規則下的修改？然後快速跟進。此外，當我們考慮未來的測試開發時，規則生效後，中期毛利率面臨同樣 100 或 200 bips 的逆風是否公平？

I think on the rules that came out from the FDA or something that I think was largely expected and if anything, maybe the borrowed a little bit lower than well telegraphed where we are is we have Guardant360 PCDX, which has been sort of under the framework of FDA. We've done multiple upgrades, software upgrades to Guardant360. You see that under some sort of that FDA framework. And so we have those capabilities were very familiar with it. We've successfully operated under that. And so yes, this is really not a change in almost any way in terms of our business, it has very minimal impact.

我認為根據 FDA 制定的規則或我認為很大程度上是預期的東西，如果有的話，也許借用的比我們所傳達的要低一點，我們有 Guardant360 PCDX，它已經在框架下FDA 的。我們對Guardant360進行了多次升級、軟體升級。你可以在 FDA 的某種框架下看到這一點。所以我們對這些能力非常熟悉。我們已經在此基礎上成功運作。是的，就我們的業務而言，這實際上幾乎沒有任何變化，它的影響非常小。

Dan Brennan, TD Cowen.

丹布倫南，TD·考恩。

Perfect. Thanks for the questions and congrats on the quarter. Maybe just zeroing in on my Guardant360clinical for a moment on, could you just give us a sense overall of clinical lines came in a little bit above our expectations. And we felt like after really strong growth last year, like you guys had set a reasonably conservative bar.

完美的。感謝您的提問並祝賀本季。也許只是暫時關註一下我的 Guardant360clinical，您能否讓我們了解臨床系列的整體情況略高於我們的預期。我們感覺，在去年的強勁成長之後，你們設定了一個相當保守的標準。

Just wondering, could you speak to any color on how Gordon Richardson clinical volumes in the quarter and kind of what you're seeing in the marketplace and you know kind of how we think about the progression throughout the rest of the year?

只是想知道，您能否談談戈登理查森在本季度的臨床銷售以及您在市場上看到的情況，以及您知道我們如何看待今年剩餘時間的進展？

Yes. I can talk about that. Probably, it’s for the growth, I mean. We said the overall clinical volume of 20% came in with our -- in line with our expectations. The same is true for Guardant360. So yes, it came in very nicely and Q1 was a difficult comp for us because in February of last year we had ESR1 approval, and we saw an immediate uptake in the price volume for Guardant360.

是的。我可以談談這個。我的意思是，可能是為了成長。我們說 20% 的臨床總量符合我們的預期。Guardant360 也是如此。所以，是的，它的表現非常好，第一季對我們來說是一個困難的競爭，因為去年 2 月我們獲得了 ESR1 批准，我們看到 Guardant360 的價格立即上升。

And we know for Q2 we’re going to have an even more difficult term; so I think we were really pleased with our G360 volume came in the first quarter. Q2 is going to be hard come, but we still think we can get to see continued sequential growth and I think we're looking at higher year-over-year volume growth for G360 in the back half of the year.

我們知道第二季我們將面臨一個更困難的時期；所以我認為我們對第一季 G360 的銷售非常滿意。第二季將是艱難的，但我們仍然認為我們可以看到持續的環比增長，我認為我們預計 G360 在今年下半年的銷售將實現更高的同比增長。

Yes, no, I mean, Mike, I think we're excited with the second half because we're just seeing a lot of the initiatives we have, I think, are going to stick in terms of this EMR integration, international and smart liquid biopsy transition. So yes, we started operating better than we expected them. I think it's going to be that in a good year in general.

是的，不，我的意思是，邁克，我認為我們對下半年感到興奮，因為我們剛剛看到我們擁有的許多舉措，我認為，將在電子病歷集成、國際化和智能方面堅持下去液體活檢過渡。所以，是的，我們開始運作得比我們預期的要好。我認為總的來說，這將是美好的一年。

Eve Bernstein, Bernstein Research.

伊芙‧伯恩斯坦，伯恩斯坦研究中心。

Hi, this is Alberto [butcher] on for Eve. Thank you for taking my question. I wanted to ask more of a long-term question. You have more than $1 billion in convertible debt due in 2027, and we already have seen some other company to be penalized for that. Your Investor Day, you said that you don't plan to be cash flow positive, if not before 2028, we have been assuming that you will need to raise money for that. So what are the options you're considering?

嗨，我是阿爾貝托（屠夫）為夏娃服務。感謝您回答我的問題。我想問更多一個長期的問題。您有超過 10 億美元的可轉換債務將於 2027 年到期，我們已經看到其他一些公司因此受到處罰。在您的投資者日，您說您不打算實現正現金流，如果不是在 2028 年之前，我們一直假設您需要為此籌集資金。那麼您正在考慮哪些選擇呢？

Are you having this discussion now and how you're thinking about brings in more of your expense profile ahead of that.

您現在正在討論這個問題嗎？

Yes, I mean, I think the first thing to say is our cash balance at the end of this quarter was over $1.1 billion. And you know, I think we've been pretty consistent in saying that over the next few years, our cash burn is going to come down every year and that to get to that sort of breakeven level in 2028, the cash that we've got is more than sufficient to get us back. And in fact, you know, with the traction that we've seen with ASPs and actually the reduction in cash burn that we've just had brought down for the full year.

是的，我的意思是，我認為首先要說的是，本季末我們的現金餘額超過 11 億美元。你知道，我認為我們一直一致表示，在接下來的幾年裡，我們的現金消耗將逐年下降，到 2028 年達到盈虧平衡水平，我們已經擁有的現金得到的足以讓我們回來。事實上，你知道，我們已經看到了 ASP 的吸引力，以及我們剛剛實現的全年現金消耗的減少。

Just now, I think the potential that we can get to that break-even level for the company potentially earlier than 2028. So yes, we're really focused on how quickly we can drive to profitability.

就目前而言，我認為我們公司有可能在 2028 年之前達到收支平衡水準。所以，是的，我們真正關注的是我們能夠以多快的速度實現盈利。

As far as the convertible, I mean, we're well aware of that at the moment. It's got a 0% coupon. It's maturities until 2027 and so we're feeling relatively comfortable with having that on the balance sheet at the moment. But we're continually looking at what our options are with who we're talking to a lot of people, we want to make sure that we make the rights the right decision and do the right thing. But I think you've got the advantage of time on our side, but it's something we're aware of and we'll know we need to address it at some point in the future.

我的意思是，就敞篷車而言，我們目前很清楚這一點。它有 0% 優惠券。它的到期日到 2027 年，因此我們目前對將其納入資產負債表感到相對滿意。但我們一直在與我們正在與許多人交談的人一起研究我們的選擇，我們希望確保我們做出正確的決定並做正確的事情。但我認為我們擁有時間優勢，但這是我們意識到的事情，我們知道我們需要在未來的某個時候解決它。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Hey, guys, thanks for the question. So I know you're not providing much on the advisory committee but just wondering, is frequency-- will the frequency of assay would be a consideration there? And then maybe just looking competitively across the landscape, we have some seen some readouts, there are some expected readouts that are coming as well later this year.

嘿，夥計們，謝謝你的提問。所以我知道您在諮詢委員會中沒有提供太多信息，但只是想知道頻率 - 檢測頻率是否會成為考慮因素？然後也許只是在整個競爭格局中觀察，我們看到了一些讀數，還有一些預期的讀數將於今年稍後發布。

Does that change your view at all in terms of how the field is positioned competitively in the marketplace? If there is a competitor that has maybe a larger commercial presence introducing an asset down later this year, does that change any thinking on your end as to how you're progressing with Shiled.

這是否會改變您對該領域在市場競爭中的定位的看法？如果有一個競爭對手可能擁有更大的商業影響力，並在今年稍後推出一項資產，這是否會改變您對如何與 Shiled 取得進展的想法。

Yes Puneet. So in terms of the AdCom, we are going to that meeting very confident and excited in terms of really the final topic, final agenda, lighted Sky did release slate in a couple days before the meeting by agency and any other potential changes that could happen anytime laid down.

是的，普尼特。因此，就 AdCom 而言，我們對最終主題、最終議程非常有信心和興奮地參加了這次會議，Lighted Sky 確實在會議前幾天發布了代理商名單以及可能發生的任何其他潛在變化隨時躺下。

So we are going to have all the final information very soon here, just literally two weeks away from that AdCom date right now. In terms of actually competitor data, Shield is the best in class technology, the best in class performance.

因此，我們很快就會在這裡獲得所有最終信息，距離 AdCom 日期只有兩週時間。就實際競爭對手的數據而言，Shield 是一流的技術、一流的性能。

And now we did further extend that kind of a first mover time advantafe. And frankly, like I'm not sure if you're seeing an incredible computing blood test at this time. So we are going to continue to monitor this field. But with this time advantage performance that we have here in the very late innings of FDA approval and we feel very comfortable with where we are competitively and we'll see if anybody else is going to have anything at the end of the day. So we are even more excited about the opportunity right now that had been few quarters ago.

現在我們確實進一步擴大了這種先發時間優勢。坦白說，我不確定你現在是否看到了令人難以置信的計算血液測試。因此我們將繼續關注這一領域。但憑藉我們在 FDA 批准的最後幾局中所擁有的時間優勢表現，我們對自己的競爭地位感到非常滿意，我們將看看其他人最終是否會擁有任何東西。因此，我們對現在的機會比幾個季度前的機會更加興奮。

Rachel Batten Dahl, JPMorgan.

雷切爾·巴頓·達爾，摩根大通。

Thank you. This is Casey Woodring on for Rachel. So biopharma had a strong quarter. Test volumes were up 37%. I think revenue is up 40%. 1q is obviously a strong quarter from a biopharma funding perspective. So can you just walk us through the rationale for reiterating your 2024 revenue forecast there for low 10s growth? And maybe how much upside there would be that number if funding were to hold at current levels or even continue to improve here relative to where funding levels were when you initiated the guide. Thank you.

謝謝。我是凱西·伍德林 (Casey Woodring) 替補雷切爾 (Rachel) 發言。因此，生物製藥季度表現強勁。測試量增加了 37%。我認為收入增長了 40%。從生物製藥融資的角度來看，第一季顯然是一個強勁的季度。那麼，您能否向我們介紹一下重申 2024 年營收預測為 10 % 低成長率的理由？如果資金保持在當前水平，甚至相對於您啟動指南時的資金水平繼續改善，那麼這個數字可能會有多少上升空間。謝謝。

Yes, I can tell you some of the biopharma came in incredibly incredibly strongly for us in the first quarter. You know, we had a we had a strong pipeline coming into the year and so that came through in looking at our pipeline now is still it's still very strong. I think we said in the prepared remarks, we're sort of maintaining our overall guide for biopharma.

是的，我可以告訴你，有些生物製藥在第一季對我們來說非常強勁。你知道，今年我們有一個強大的管道，所以現在看看我們的管道仍然非常強大。我想我們在準備好的發言中說過，我們正在維持我們的生物製藥總體指南。

Just really, we wanted to be conservative and we want to just ensure that there's no adverse impacts to the biopharma funding. So the macro environment that might cause a potential reduction in the back half of the year. So definitely there's upside in the back half of the year for us on biopharma to quantify that is it difficult.

事實上，我們想要保守一點，我們只想確保生物製藥資金不會受到不利影響。所以宏觀環境可能會導致下半年潛在的減少。因此，今年下半年我們在生物製藥領域肯定會有上漲空間，但很難量化。

I think if you sort of back into on our guide, we were almost sort of guiding to sort of flat year over year in the back half of the year. So I think we feel hopeful that we can have upside there. But again, it's difficult to quantify, but the pipeline is looking strong for us in the near term.

我想，如果你回顧我們的指南，我們幾乎是在下半年實現了同比持平的指導。所以我認為我們對能夠在這方面取得進步充滿希望。但同樣，這很難量化，但短期內我們的管道看起來很強勁。

Mathew Sykes, Goldman Sachs.

馬修賽克斯，高盛。

Hi, guys, good afternoon. This is Will Meyer on for Matt. Great to see the gross margin raise at the start of the year, it sounds like the higher ASP was probably a big driver there. But can you give us some more color on any other drivers or moving pieces you're seeing and what are your expectations for phasing on gross margin for the rest of the year? Thank you.

嗨，夥計們，下午好。我是威爾·邁耶 (Will Meyer) 替馬特 (Matt) 發言。很高興看到年初毛利率上升，聽起來較高的平均售價可能是那裡的一個重要推動因素。但您能否給我們更多關於您所看到的其他驅動因素或移動部件的信息，以及您對今年剩餘時間毛利率的預期是什麼？謝謝。

Yes. No, we were really pleased on the gross margin. The real driver of this cause was the ASP impact. And so -- as we said in the prepared remarks, we raised our expectation of ASP for Guardant360 for the remainder of the year. We also saw good commercial reimbursement on Reveal and TissueNext as well. So, if that was to continue through the year in this potential upside there on the gross margin, we -- we sort of do want to offset that a little bit by the mix.

是的。不，我們對毛利率非常滿意。這原因的真正驅動因素是 ASP 的影響。因此，正如我們在準備好的演講中所說，我們提高了今年剩餘時間內 Guardant360 的 ASP 預期。我們還在 Reveal 和 TissueNext 上看到了良好的商業報銷。因此，如果這一毛利率的潛在上升趨勢在今年持續下去，我們確實希望透過混合來抵消這一點。

We're managing our Reveal volume mix -- if we were to take the foot off the brake on Reveal, that could have had an impact and those are the different mix impacts as well that we tried to manage but -- overall, we're really pleased gross margins are improving. We see a line of sight, IRA is potentially even higher than gross margin. So I think we started the year very well from that perspective.

我們正在管理我們的 Reveal 音量混合 - 如果我們在 Reveal 上鬆開剎車，這可能會產生影響，這些也是我們試圖管理的不同混合影響，但是 - 總的來說，我們'我們非常高興毛利率正在改善。我們看到一個視線，IRA 甚至有可能高於毛利率。所以我認為從這個角度來看，我們今年的開局非常好。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Doug, your line is now open. Thank you so much. Appreciate you taking my questions. So I want I want to talk about two things. One is SHIELD and then two is really R&D spend and prioritization as we look ahead on field, I'm maybe asking an earlier question a different way what do you think the realistic range of outcomes is for AdCom later this month to recognizing that you've consistently said you believe this is a three year testing interval product, if you happen to be wrong and this is in every one year test to the economics work.

道格，您的路線現已開通。太感謝了。感謝您回答我的問題。所以我想談兩件事。一是SHIELD，二是真正的研發支出和優先順序，當我們展望這一領域時，我可能會以不同的方式問之前的一個問題，您認為本月晚些時候AdCom 認識到您的實際結果範圍是多少？ 我一直說你相信這是一個三年測試間隔的產品，如果你碰巧錯了，這是對經濟工作的每年測試。

And then what is your expectation for USPSTF timing as we sit here today, there's been some commentary from others that this is seemingly being pushed out a little bit. And I'll come back and ask about R&D in a second.

那麼當我們今天坐在這裡時，您對 USPSTF 的時間表有何期望，其他人有一些評論稱這似乎被推遲了一點。我稍後會回來詢問研發的狀況。

Yes. So in terms of ad comm, several questions, yes. So in terms of ad comm, you know, probably the typical question in terms of safety, efficacy and benefit, risk is going to be discussed in the panel and the range of outcomes as advisors are now looking into our data, everything and decide what they want to vote on in terms of those questions.

是的。所以就廣告傳播而言，有幾個問題，是的。因此，就廣告交流而言，您知道，可能會在小組中討論安全性、有效性和效益、風險以及結果範圍方面的典型問題，因為顧問現在正在研究我們的數據、一切並決定什麼他們想就這些問題進行投票。

But we are very confident with all the profile of the data that we have to study that we've done and the reported device performance that we reported and published, and that the same kind of performance is kind of presented there.

但我們對我們必須研究的所有數據概況以及我們報告和發布的設備性能非常有信心，並且在那裡呈現出相同類型的性能。

So we will see in terms of how that ad comm goes. We feel great about it. In terms of USPTF, in terms of the interval and three years testing, I mentioned this before, if -- you know, the interval test for Shield becomes even more frequent than every three years, in fact, it’s going to be an offside process.

因此，我們將看看廣告傳播的進展。我們對此感覺很好。就USPTF而言，就間隔和三年測試而言，我之前提到過這一點，如果——你知道，Shield的間隔測試變得比每三年更頻繁，事實上，它將會是越位過程。

So in a land that FDA approved diagnostic test, pricing is going to get set, Medicare price is going to set in ABLT process. Every year testing frankly, would be even an offside in terms of our P&L. We believe based on the modeling that we've done, it's over utilization of Shield. But annual testing is an upside, not a down side.

因此，在 FDA 批准診斷測試的土地上，定價將會確定，醫療保險價格將在 ABLT 過程中確定。坦白說，每年的測試，就我們的損益而言，甚至會是越位。根據我們所做的建模，我們認為 Shield 的使用過度了。但每年測試是一個好處，而不是壞處。

The last one was what? That's it ? Okay.

最後一張是什麼？就是這樣？好的。

Mason Carrico, Stephens.

梅森·卡里科，史蒂芬斯。

Hey, guys. Thanks for the questions. Here's sorry if this has been Scott jumping between a few tonight. So in terms of your expectations for SHIELD, you've talked about how a second label is still big opportunity, your commitment to screening as long as it continues to fall in line with your expectations of the opportunity. So assuming you get a second a second line label, as we look into next year, what is a realistic adoption hurdle for you guys ?

大家好。感謝您的提問。如果史考特今晚在幾個人之間跳來跳去，我很抱歉。因此，就您對神盾局的期望而言，您談到了第二個標籤仍然是一個巨大的機會，只要它繼續符合您對機會的期望，您就會致力於篩選。因此，假設您獲得了第二個二線標籤，當我們展望明年時，對您來說，現實的採用障礙是什麼？

Exact to the 100,000 Cologuard tests, I believe in their first year after FDA approval, meaning maybe you guys are in a bit of better position commercially than they were at that time maybe you're not. But is there any sort of hurdle or framework you can give us for expectations next year where volumes may fall ?

我相信 FDA 批准後的第一年就進行了 100,000 次 Cologuard 測試，這意味著你們在商業上的地位可能比當時更好，也可能不是。但是，您是否可以為我們提供任何類型的障礙或框架來預測明年的銷售可能會下降？

In general, our expectation up by (inaudible) is as follow on, a conversation with the FDA is to take Shield to the finish line and get FDA approval. That would be the definition of success for Shield from our perspective to have a huge opportunity in front of us. And a fair there is obviously, if we cannot comment on FDA to approve this tests, that could be very unexpected, but we'll see what happens. I

總的來說，我們的期望（聽不清楚）如下，與 FDA 的對話是讓 Shield 到達終點線並獲得 FDA 的批准。從我們的角度來看，這就是 Shield 成功的定義，因為我們面前有巨大的機會。顯然，如果我們不能對 FDA 批准這項測試發表評論，這可能是非常出乎意料的，但我們會看看會發生什麼。我

In terms of second line, what was the biggest opportunity for blood-based CRC screening and the biggest opportunity in general for noninvasive CRC screening is this $50 million on the same patient population, which are out there right now and as that market segment is constantly open for a second line indication.

就二線而言，基於血液的 CRC 篩檢的最大機會和一般非侵入性 CRC 篩檢的最大機會是針對同一患者群體的 5000 萬美元，這些患者目前就存在，並且該細分市場不斷變化打開第二行指示。

So that's why we continue to be excited to go to market with Shield that with the second line indication. Having said that, we have milestones, we have some assumption in terms of audio brands and revenue contribution, and there are signs that we are going to monitor the commercial execution and is still that market is as exciting as what we think it is right now.

這就是為什麼我們繼續興奮地將具有二線適應症的 Shield 推向市場。話雖如此，我們有里程碑，我們在音頻品牌和收入貢獻方面有一些假設，有跡象表明我們將監控商業執行情況，市場仍然像我們現在認為的那樣令人興奮。

In terms of sending a specific guidance for next year, we would talk about it at the right time depends on the timing of FDA approval and some other factors., I'm pretty sure we would talk about it and future sometime in 2024.

至於明年發送具體指南，我們會在適當的時間討論它，具體取決於 FDA 批准的時間和其他一些因素。

Thank you. That is all the time that we have for questions today. I will turn the call back over for any final concluding remarks.

謝謝。這就是我們今天提問的全部時間。我將把電話轉回以聽取最後的結論性意見。

Thank you so much for everybody's interest. Have a good day and night.

非常感謝大家的關注。祝你有個愉快的一天和一夜。

That concludes today's call. Thank you all for your participation, and you may now disconnect your lines.

今天的電話會議到此結束。感謝大家的參與，現在您可以斷開線路了。