Guardant Health Inc (GH) 2023 Q1 法說會逐字稿

Hello, and welcome to the Guardant Health First Quarter 2023 Financial Results Call. My name is Lauren, and I will be coordinating your call today. (Operator Instructions)

您好，歡迎來到 Guardant Health 2023 年第一季度財務業績電話會議。我叫勞倫，今天我將負責協調您的來電。 （操作員說明）

I will now hand you over to your host, Alex Kleban, Vice President of Investor Relations, to begin. Alex, please go ahead.

現在我將把你交給你的東道主，投資者關係副總裁 Alex Kleban。亞歷克斯，請繼續。

Thank you. Earlier today, Guardant Health released financial results for the quarter ended March 31, 2023. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer. Craig Eagle, Guardant's Chief Medical Officer, will join for Q&A.

謝謝。今天早些時候，Guardant Health 發布了截至 2023 年 3 月 31 日的季度財務業績。今天從 Guardant 加入我的是聯席首席執行官 Helmy Eltoukhy； AmirAli Talasaz，聯合首席執行官；和首席財務官 Mike Bell。 Guardant 的首席醫療官 Craig Eagle 將參加問答環節。

Before we begin, I'd like 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. This call will also include a discussion of non-GAAP financial measures to adjust and to exclude certain specified items.

在我們開始之前，我想提醒您，在本次電話會議期間，管理層將根據聯邦證券法做出前瞻性陳述。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存在重大差異。此電話會議還將討論非 GAAP 財務措施，以調整和排除某些特定項目。

Additional information regarding material risks and uncertainties as well as reconciliations to the most directly comparable GAAP financial measures are available in the press release Guardant issued today as well as in our Form 10-K and other filings with the SEC. 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. Information in this conference call is accurate only as of the live broadcast.

有關重大風險和不確定性的更多信息，以及與最直接可比的 GAAP 財務措施的對賬，請參閱 Guardant 今天發布的新聞稿以及我們向美國證券交易委員會提交的 10-K 表格和其他文件。 Guardant 不承擔因新信息、未來事件或其他原因而更新或修改財務預測和前瞻性陳述的任何意圖或義務。本次電話會議中的信息僅在現場直播時準確無誤。

With that, I'd like to turn the call over to Helmy.

有了這個，我想把電話轉給 Helmy。

Thanks, Alex. Good afternoon, and thank you for joining our order first quarter 2023 earnings call. I will start off today's call today for providing an update on our progress so far in 2023 and go into more detail on our progress in therapy selection and MRD. I will then turn the call over to AmirAli for an update on screening. And finally, Mike will provide a more detailed look at our financials and outlook for 2023.

謝謝，亞歷克斯。下午好，感謝您加入我們的訂單 2023 年第一季度財報電話會議。我將在今天開始今天的電話會議，提供我們 2023 年迄今為止的最新進展，並更詳細地介紹我們在治療選擇和 MRD 方面的進展。然後，我會將電話轉給 AmirAli，以獲取篩選的最新信息。最後，Mike 將更詳細地介紹我們 2023 年的財務狀況和展望。

At Guardant, we have built one of the fastest-growing platforms in diagnostics, coupled with what we believe is the most exciting pipeline in the industry to fuel long-term growth. Today, we are the market leader in therapy selection and technology innovators at the forefront of MRD in cancer screening. All of this enables us to help patients at all stages of cancer live longer and healthier lives.

在 Guardant，我們已經建立了診斷領域增長最快的平台之一，加上我們認為是業內最令人興奮的管道，可以推動長期增長。今天，我們是癌症篩查 MRD 最前沿的療法選擇和技術創新者的市場領導者。所有這些使我們能夠幫助癌症各個階段的患者活得更長、更健康。

In line with this, I would like to start off with a patient story. A 43-year-old woman, with no history of smoking, went to a physician with chest pain. A CT scan ruled out a pulmonary embolism that showed a 3.5-centimeter mass. Following additional tests, she was diagnosed with stage 3 lung adenocarcinoma. Further testing from other modalities indicated the tumor was negative for EGFR, ALK and ROS1.

與此相一致，我想從一個耐心的故事開始。一名沒有吸煙史的 43 歲女性因胸痛去看醫生。 CT 掃描排除了肺栓塞，顯示有 3.5 厘米的腫塊。經過額外的檢查，她被診斷出患有 3 期肺腺癌。其他方式的進一步測試表明腫瘤對 EGFR、ALK 和 ROS1 呈陰性。

However, a Guardant360 liquid biopsy revealed several somatic mutations, including a ROS1 fusion, making her candidate for the targeted therapy, entrectinib. Following treatment for oncologist-ordered imaging to confirm whether or not she was responding to therapy, which came back inconclusive, a Guardant response test was ordered and detected no ctDNA, indicating she was responding to therapy. One year into treatment, she continues to do well with an over 50% reduction in the primary tumor mass and complete resolution of other nodules. Her story illustrates the power of the combined Guardant360 in response testing regimen that these doctors making these crucial decisions to deliver better patient outcomes.

然而，Guardant360 液體活檢顯示了幾個體細胞突變，包括 ROS1 融合，使她成為靶向治療 entrectinib 的候選者。在接受腫瘤科醫生要求的影像學檢查以確認她是否對治療有反應後，結果尚無定論，隨後進行了 Guardant 反應測試，但未檢測到 ctDNA，表明她對治療有反應。治療一年後，她繼續保持良好狀態，原發腫瘤塊減少了 50% 以上，其他結節完全消退。她的故事說明了聯合 Guardant360 在反應測試方案中的力量，這些醫生做出這些關鍵決定以提供更好的患者結果。

Turning to Slide 4. We started the year off strong with our first quarter revenue growing 34% to $128.7 million. Guardant360 continues to be the main growth driver with increasing contributions from Reveal and TissueNext.. Our team continues to focus on delivering superior execution, operations and customer service. All in all, we accelerated our growth in the quarter in the stable market conditions, driving market expansion in a backdrop of notable retrenchments by competitors.

轉到幻燈片 4。我們今年開局強勁，第一季度收入增長 34% 至 1.287 億美元。隨著 Reveal 和 TissueNext 貢獻的增加，Guardant360 繼續成為主要的增長動力。我們的團隊繼續專注於提供卓越的執行、運營和客戶服務。總而言之，我們在穩定的市場條件下加快了本季度的增長，在競爭對手顯著收縮的背景下推動了市場擴張。

Turning to Slide 5. We are pleased to report that in mid-April, we received Medicare reimbursement for Guardant Response. This is our fifth assay to receive Medicare reimbursement. It is the first blood-only liquid biopsy for immunotherapy response monitoring, representing a major step forward for patients. The overall testing program will consist of the Guardant360 test and treatment initiation, followed by a response test in the appropriate time frame. Our rate for response has been finalized at $1,943, and we are exploring an ADLT pathway for this test in the medium term, which should increase pricing further.

轉到幻燈片 5。我們很高興地報告，在 4 月中旬，我們收到了 Guardant Response 的醫療保險報銷。這是我們第五次獲得醫療保險報銷的化驗。這是第一個用於免疫治療反應監測的純血液液體活檢，代表著患者向前邁出的重要一步。整體測試計劃將包括 Guardant360 測試和治療啟動，然後在適當的時間範圍內進行響應測試。我們的回复率最終確定為 1,943 美元，我們正在探索中期進行此測試的 ADLT 途徑，這應該會進一步提高定價。

Turning to Slide 6. After another record quarter in which we continued to significantly grow market share, we want to take a moment to spotlight our core therapy selection business. Over the years, we have built on the foundation of the first FDA-approved comprehensive liquid biopsy to create what we believe is the strongest platform in oncology diagnostics. Our entire therapy selection portfolio is now reimbursed by Medicare with reach to over 300 million covered lives when we include commercial payers.

轉到幻燈片 6。在我們繼續顯著增加市場份額的又一個創紀錄的季度之後，我們想花點時間來強調我們的核心治療選擇業務。多年來，我們在第一個 FDA 批准的綜合液體活檢的基礎上建立了我們認為是腫瘤診斷領域最強大的平台。當我們包括商業付款人時，我們的整個治療選擇組合現在由 Medicare 報銷，涵蓋的生命超過 3 億。

We have established ourselves as technology and market leaders with a greater than 300-person commercial team across clinical and biopharma, over 12,000 ordering oncologists, more than 150 biopharma customers, all supported by hundreds of patents and clinical publications. Achieving scale is not a long-term vision, but at our doorstep. For a therapy selection, which represents more than 95% of our total revenue, we expect to generate more than $500 million in sales this year with clinical revenue growth of greater than 25%, gross margins above 60%, and reach cash flow breakeven in 6 to 9 months.

我們已經確立了自己作為技術和市場領導者的地位，擁有超過 300 人的臨床和生物製藥商業團隊、超過 12,000 名訂購腫瘤學家、超過 150 家生物製藥客戶，所有這些都得到數百項專利和臨床出版物的支持。實現規模不是一個長期的願景，而是在我們家門口。對於占我們總收入 95% 以上的治療選擇，我們預計今年將產生超過 5 億美元的銷售額，臨床收入增長超過 25%，毛利率超過 60%，並在 2018 年實現現金流盈虧平衡6 到 9 個月。

Moving on to Slide 7. Clinical test volume reached over 39,100 tests in the first quarter, up 45% compared to the prior-year quarter. Guardant360 continues to be the main driver with continued strong growth in lung cancer with a significant uptake in breast cancer following our CDx approval for ESR1 mutations early in the quarter. Guardant Reveal and TissueNext added to the growth as we rapidly onboarded patients in MRD and also gained market share, driven by the recent launch of our AI-powered Guardant Galaxy tissue offering.

轉到幻燈片 7。第一季度臨床試驗量達到 39,100 多次試驗，比去年同期增長 45%。在本季度初我們對 ESR1 突變的 CDx 批准後，Guardant360 繼續成為肺癌持續強勁增長的主要驅動力，乳腺癌的發病率顯著上升。 Guardant Reveal 和 TissueNext 促進了增長，因為我們在 MRD 中迅速吸引了患者，並且在我們最近推出的 AI 驅動的 Guardant Galaxy 組織產品的推動下也獲得了市場份額。

We continue to execute on building account depth with more oncologists ordering more Guardant tests again in the quarter. This is due, in large part, to the leverage we are gaining from past investments in EMR integration, processes and systems. We saw a nice upward move in our Guardant360 ASPs, supported by mix and positive momentum from commercial payers. We are closing on coverage from all major commercial payers in the U.S. for Guardant360, given the addition of United during Q1, Aetna, Humana expected in Q2 and others that are in advanced discussions. Our ESR1 CDx has been a major driver and is helping us to address remaining coverage limitations. All of this is providing a tailwind for ASP.

隨著更多腫瘤學家在本季度再次訂購更多 Guardant 測試，我們繼續執行建立客戶深度的工作。這在很大程度上是由於我們從過去對 EMR 集成、流程和系統的投資中獲得的槓桿作用。在商業付款人的組合和積極勢頭的支持下，我們看到 Guardant360 ASP 出現了不錯的上升趨勢。考慮到在第一季度增加了 United，預計在第二季度增加了 Aetna、Humana 以及其他正在進行高級討論的公司，我們將關閉美國所有主要商業付款人對 Guardant360 的報導。我們的 ESR1 CDx 一直是主要的驅動力，正在幫助我們解決剩餘的覆蓋範圍限制。所有這些都為 ASP 提供了順風。

Turning to Slide 8. We had another solid quarter of biopharma growth with volumes up 21%. Our partnerships continue to rise, and we have now converted more than 20% of our mix to GuardantINFINITY, our epigenomic or smart liquid biopsy-based panel, and also continue to see strong utilization of Guardant360 CDx. In addition, we announced another ESR1 collaboration and are on target to start seeing China sales ramp up later in 2023.

轉到幻燈片 8。我們又迎來了一個穩定的生物製藥增長季度，銷量增長了 21%。我們的合作夥伴關係繼續增加，我們現在已經將超過 20% 的組合轉換為 GuardantINFINITY，這是我們的表觀基因組或基於智能液體活檢的面板，並且繼續看到 Guardant360 CDx 的大量使用。此外，我們還宣布了另一項 ESR1 合作，目標是在 2023 年晚些時候開始看到中國銷量的增長。

Turning to Slide 9. With our strongest quarter yet in breast cancer, I would like to highlight the transformational potential that our CDx can have for breast cancer that develop an ESR1 mutation. Between 65% and 80% of breast cancers in women are estrogen receptor or ER positive, and up to 40% of patients with ER-positive HER2-negative cases will develop an ESR1 mutation, which qualifies them for a new class of targeted therapy. ESR1 mutations can emerge months or years after initial tissue or liquid biopsy, demonstrating a real need for liquid biopsy testing. With 6 biopharma partnerships focused on ESR1 already, this will be a key focus area for CDx programs where our partners can leverage Guardant technical and regulatory capabilities.

轉到幻燈片 9。憑藉我們在乳腺癌領域迄今為止最強勁的季度，我想強調我們的 CDx 對發生 ESR1 突變的乳腺癌的轉化潛力。 65% 到 80% 的女性乳腺癌是雌激素受體或 ER 陽性，高達 40% 的 ER 陽性 HER2 陰性病例會發生 ESR1 突變，這使她們有資格接受一類新的靶向治療。 ESR1 突變可在初始組織或液體活檢後數月或數年出現，表明確實需要進行液體活檢檢測。已經有 6 個生物製藥合作夥伴專注於 ESR1，這將是 CDx 計劃的一個關鍵重點領域，我們的合作夥伴可以在其中利用 Guardant 的技術和監管能力。

I'd like to take a moment to thank our team who work tirelessly to ensure we live up to our most important value to put the patient first. Everything we do is led by that North Star. At Guardant, we have built one of the most transformative platforms in diagnostics, and we think extensively about how we get our work done more efficiently, from development through delivery to fulfill our primary mission of helping patients.

我想花點時間感謝我們的團隊，他們孜孜不倦地工作，以確保我們踐行我們最重要的價值觀，即把病人放在第一位。我們所做的一切都是由那顆北極星引導的。在 Guardant，我們已經建立了診斷領域最具變革性的平台之一，我們廣泛思考如何更有效地完成我們的工作，從開發到交付，以完成我們幫助患者的主要使命。

In line with that goal, we recently made some key additions to our leadership team in an effort to further improve our ability to operate effectively while balancing our need to innovate quickly. Ines Dahne-Steuber joined Guardant as our new Chief Operating Officer. Ines brings more than 2 decades of broad diagnostics experience, including overseeing operations for labs, running millions of tests per year. Under her leadership, we will bring further efficiency, leverage and scale to the way we operate as a company.

為了實現這一目標，我們最近對我們的領導團隊進行了一些重要的補充，以進一步提高我們有效運營的能力，同時平衡我們對快速創新的需求。 Ines Dahne-Steuber 加入 Guardant，擔任我們的新首席運營官。 Ines 擁有超過 2 年的廣泛診斷經驗，包括監督實驗室運營，每年進行數百萬次測試。在她的領導下，我們將為公司的運營方式帶來更高的效率、影響力和規模。

Darya Chudova was promoted to Chief Technology Officer. With this newly created role, we are bringing together our research and development efforts for oncology and screening to leverage our products across a single platform and allow us to scale more quickly and efficiently. I look forward to their contributions and strategic leadership to help Guardant continue to scale for this next exciting chapter of our journey. I'm very proud of our team and our products and look forward to the opportunities ahead.

Darya Chudova 晉升為首席技術官。有了這個新設立的角色，我們將我們在腫瘤學和篩查方面的研發工作結合起來，以在單一平台上利用我們的產品，並使我們能夠更快、更有效地擴大規模。我期待著他們的貢獻和戰略領導力，以幫助 Guardant 繼續擴展我們旅程的下一個激動人心的篇章。我為我們的團隊和我們的產品感到非常自豪，並期待著未來的機會。

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

有了這個，我現在將把電話轉給 AmirAli，以提供我們篩選業務的最新情況。

Thank you, Helmy. Turning to Slide 10. We continue to make good progress in our screening business as we spearhead a new patient-preferred category in the screening market. Our PMA for Shield for its first clinical indication of CRC screening is now filed with FDA, and the review process is underway. Shield demonstrated 83% sensitivity and 90% specificity in the ECLIPSE trial, in range with other guideline-recommended noninvasive CRC screening tests, where performance ranges from 74% to 92%. We believe this test performance, not only is above the bar for FDA approval and Medicare coverage, but also meets the requirement for a robust commercial success post FDA approval. In addition, the real-world customer feedback from our LDT-ordering physicians continue to exceed our expectations and validates the value of incorporating Shield test into screening menus.

謝謝你，赫爾米。轉到幻燈片 10。隨著我們在篩查市場上率先推出一個新的患者首選類別，我們在篩查業務方面繼續取得良好進展。我們的首個 CRC 篩查臨床適應症的 Shield PMA 現已提交給 FDA，審查過程正在進行中。 Shield 在 ECLIPSE 試驗中表現出 83% 的敏感性和 90% 的特異性，與指南推薦的其他無創 CRC 篩查試驗的範圍在 74% 至 92% 之間。我們相信這種測試性能不僅高於 FDA 批准和醫療保險覆蓋範圍的標準，而且符合 FDA 批准後取得穩健商業成功的要求。此外，我們的 LDT 訂購醫生的真實客戶反饋繼續超出我們的預期，並驗證了將 Shield 測試納入篩選菜單的價值。

Moving to Slide 11. Just this morning, at Digestive Disease Week, the study investigators presented additional details and insights from our pivotal ECLIPSE study. We are fortunate to host a call with the trial investigators and other cancer screening experts to share their perspective on these results. The performance of screening test in detecting early-stage CRCs is an important parameter. CRCs with Stage 1, 2, 3 have a very high survival rate with 72% to 91% of patients surviving at 5 years post treatment.

轉到幻燈片 11。就在今天早上，在消化系統疾病週上，研究人員介紹了我們關鍵的 ECLIPSE 研究的更多細節和見解。我們很幸運能夠與試驗研究人員和其他癌症篩查專家進行電話交流，分享他們對這些結果的看法。篩查試驗在檢測早期 CRC 方面的性能是一個重要參數。 1、2、3 期 CRC 的存活率非常高，72% 至 91% 的患者在治療後 5 年存活。

For advanced Stage 4 CRCs 5-year survival rate is only 14%. The sensitivity of Shield in detecting stage 1 to 3 was 81%. For localized CRCs, meaning no sign of spread beyond the bowel wall, which would likely be cured through surgical procedures, Shield sensitivity was 72%. For regional and distant cancers, where cancer has spread to nearby lymph nodes or to distant part of the body, Shield sensitivity was 100%.

對於晚期 4 期 CRC，5 年生存率僅為 14%。 Shield 在檢測階段 1 到 3 中的靈敏度為 81%。對於局部 CRC，這意味著沒有擴散到腸壁外的跡象，這很可能通過外科手術治愈，Shield 敏感性為 72%。對於局部和遠處的癌症，即癌症已經擴散到附近的淋巴結或身體的遠處部位，Shield 敏感性為 100%。

Taking a closer look by cancer stage, Shield detected 55% of stage 1 CRCs, 100% of all CRCs with stage 2, 100% of CRCs with stage 3 and 100% of CRCs with Stage 4. Based on this performance, we believe that as a longitudinal screening test, taken every 3 years, Shield will detect nearly all CRCs at a curable stage and will save many lives.

按癌症分期仔細觀察，Shield 檢測到 55% 的第 1 期 CRC、100% 的第 2 期 CRC、100% 的第 3 期 CRC 和 100% 的第 4 期 CRC。基於這一表現，我們認為作為每 3 年進行一次的縱向篩查測試，Shield 將檢測出幾乎所有處於可治愈階段的 CRC，並將挽救許多生命。

I want to take a moment to highlight a few notable details. Three CRCs were lost to clinical follow-up and could not be staged. As a result, they were excluded from the staging analysis. Shield detected 2 out of the 3 excluded CRCs. In addition, the study had 5 small T1 malignant polyps, which were excised during a colonoscopy procedure and considered fully treated by their doctor, hence, they had no further staging.

我想花點時間強調一些值得注意的細節。三個 CRC 失去了臨床隨訪，無法分期。因此，他們被排除在分期分析之外。 Shield 在 3 個排除的 CRC 中檢測到 2 個。此外，該研究有 5 個小的 T1 惡性息肉，這些息肉在結腸鏡檢查過程中被切除，並被他們的醫生認為已完全治療，因此，他們沒有進一步分期。

For the purpose of the staging analysis, they were all considered as stage 1. Of these, 1 was detected by Shield. Now going back to the overall performance. We are confident the first generation of our Shield has everything needed to drive a major step change in lived saved and be the first commercially successful blood-based screening test for CRC. We believe the detection performance of 83% at 90% specificity exceeds the requirement for FDA approval and Medicare coverage, too critical [are those] for any test. This is a major victory for creating this new patient-preferred screening category.

出於分期分析的目的，它們都被視為第 1 階段。其中 1 個被 Shield 檢測到。現在回到整體性能。我們相信，我們的第一代 Shield 擁有推動挽救生命的重大變革所需的一切，並成為第一個商業上成功的 CRC 血液篩查測試。我們相信 83% 的檢測性能在 90% 的特異性下超過了 FDA 批准和 Medicare 覆蓋範圍的要求，對於任何測試來說都太關鍵了。這是創建這個新的患者首選篩選類別的重大勝利。

With Shield, Guardant has now set the performance bar for the future competing blood-based screening tests. We are excited to bring the first generation of Shield to market. We have a clear time advantage relative to our competitors in blood-based screening. And this first mover advantage in this new patient-preferred category will result in cost-effective commercialization activities post FDA approval.

有了 Shield，Guardant 現在已經為未來基於血液的競爭性篩查測試設定了性能標準。我們很高興將第一代 Shield 推向市場。我們在基於血液的篩查方面相對於我們的競爭對手有明顯的時間優勢。在這個新的患者首選類別中的先發優勢將導致 FDA 批准後具有成本效益的商業化活動。

The second major win provided by our first-mover advantage is the learnings we have already been able to gain from running our ECLIPSE samples. By completing our pivotal study well ahead of our competitors, we have a significant lead on further innovation and technology platform upgrades that we can incorporate into future generations of Shield. For ECLIPSE, the missed stage 1 cancers were predominantly malignant polyps excised during colonoscopy procedures that were not well represented in our development cohorts and have lower level of signals in blood.

我們的先發優勢帶來的第二個主要勝利是我們已經能夠從運行 ECLIPSE 示例中獲得的經驗教訓。通過領先於競爭對手完成我們的關鍵研究，我們在進一步的創新和技術平台升級方面處於領先地位，我們可以將其納入未來幾代的 Shield。對於 ECLIPSE，遺漏的 1 期癌症主要是在結腸鏡檢查過程中切除的惡性息肉，這些息肉在我們的開發隊列中沒有得到很好的體現，並且血液中的信號水平較低。

Since locking our PMA device last year, we captured more data through both commercial testing with Shield LBT and analyzing more screening-relevant cohorts. I'm very pleased with the progress we have already made in upgrading our platform technology performance, powered by this additional data and insights. Based on this progress, we are working on developing the second-generation Shield with the aim of improving very early stage sensitivity. Guardant has set the bar for that future test we'll need to compete with, and that bar is already moving. Just like with Guardant360, we will continue to improve test performance to lead this new patient-preferred category.

自去年鎖定我們的 PMA 設備以來，我們通過使用 Shield LBT 進行商業測試和分析更多與篩查相關的隊列來獲取更多數據。在這些額外的數據和見解的支持下，我對我們在升級平台技術性能方面已經取得的進展感到非常高興。基於這一進展，我們正在開發第二代 Shield，旨在提高極早期靈敏度。 Guardant 為我們需要與之競爭的未來測試設定了標準，並且該標準已經在移動。就像 Guardant360 一樣，我們將繼續提高測試性能，以引領這個新的患者首選類別。

Turning to Slide 12. The unmet median CRC screening is a test that gets completed. Blood test and clinical practice have demonstrated an adherence rate of 85% to 96% for Shield. In the real-world experience with our LBT over the last 12 months, we continue to show adherence rates of more than 90%. The effective sensitivity of clinical tests is a function of both the test sensitivity and the patient adherence rate. Taken together, with 83% and 90% adherence, we are confident that Shield will contribute to detecting many more CRCs at a curable stage.

轉到幻燈片 12。未滿足的中位數 CRC 篩選是一項已完成的測試。驗血和臨床實踐表明，Shield 的依從率為 85% 至 96%。在過去 12 個月的 LBT 實際體驗中，我們繼續顯示超過 90% 的依從率。臨床測試的有效靈敏度是測試靈敏度和患者依從率的函數。結合起來，83% 和 90% 的依從性，我們相信 Shield 將有助於檢測更多處於可治愈階段的 CRC。

Turning to Slide 13. Going beyond the first indication of Shield platform in CRC, we are making good progress with our lung cancer screening trial. SHIELD LUNG will pave the path for Shield to potentially be the first FDA-approved multi-cancer screening blood test. Now I would like to take a moment to talk about our milestone-driven investments and research allocation for our screening program. We anticipate that the contributing operating loss from our screening pipeline will be less than $200 million for the next 12 months. With this level of investment, we will be ready for Shield IBD launch upon successful FDA approval, deliver the second generation of Shield with even better early-stage performance, and make significant progress on indication expansion to lung cancer. Future investments would be contingent on receiving FDA approval and then gated by ongoing commercial success and revenue milestones.

轉到幻燈片 13。除了在 CRC 中使用 Shield 平台的第一個適應症，我們在肺癌篩查試驗方面取得了良好進展。 SHIELD LUNG 將為 Shield 成為第一個 FDA 批准的多癌症篩查血液測試鋪平道路。現在我想花點時間談談我們的篩選計劃的里程碑驅動的投資和研究分配。我們預計，在接下來的 12 個月中，我們的篩選管道造成的運營損失將低於 2 億美元。有了這樣的投入，我們將為Shield IBD在FDA獲批後的上市做好準備，交付具有更好早期性能的二代Shield，並在適應症擴展至肺癌方面取得重大進展。未來的投資將取決於獲得 FDA 的批准，然後受到持續的商業成功和收入里程碑的限制。

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

有了這個，我現在將把電話轉給邁克，了解我們財務的更多細節。

Thanks, AmirAli. Turning to Slide 14 to review our financial results. Total revenue for the first quarter of 2023 grew 34% to $128.7 million compared to $96.1 million in the prior-year quarter. Total precision oncology testing revenue for the first quarter was $113.4 million, increasing 35% compared to $84.1 million in the prior-year quarter. This increase was driven by strong year-over-year growth across both our clinical and biopharma businesses.

謝謝，阿米爾阿里。轉到幻燈片 14 查看我們的財務業績。 2023 年第一季度的總收入增長 34%，達到 1.287 億美元，而去年同期為 9610 萬美元。第一季度腫瘤精準檢測總收入為 1.134 億美元，與去年同期的 8410 萬美元相比增長 35%。這一增長是由我們的臨床和生物製藥業務同比強勁增長推動的。

Precision oncology revenue from clinical tests in the first quarter totaled $91.6 million, up 39% from $66.0 million for the prior-year quarter. First quarter clinical test volume was 39,100, an increase of 45% from the same period of the prior year and an increase of 9% or 3,100 tests from Q4 2022. While Guardant360 continues to be the main revenue driver, with continued strong growth in lung cancer and a significant uptick in breast cancer, we also saw more than 100% year-over-year volume growth in both Reveal and TissueNext.

第一季度來自臨床試驗的精準腫瘤學收入總計 9160 萬美元，比去年同期的 6600 萬美元增長 39%。第一季度臨床試驗量為 39,100 次，較上年同期增長 45%，較 2022 年第四季度增長 9% 或 3,100 次試驗。而 Guardant360 繼續成為主要收入驅動因素，肺部疾病持續強勁增長癌症和乳腺癌的顯著上升，我們還看到 Reveal 和 TissueNext 的銷量同比增長超過 100%。

First quarter Guardant360 ASP was towards the top end of our expected range of $2,600 to $2,700, supported by mix and positive momentum from commercial payers. Blended clinical ASP was approximately $2,340, which was slightly above the blended ASP in Q4 2022. As a reminder, blended clinical ASP will continue to be influenced by both the volume mix between Guardant360, TissueNext, Reveal and Response as well as the mix of overall clinical volume between U.S. and international. Precision oncology revenue from biopharma tests in the first quarter totaled $21.8 million, up 20% from $18.1 million for the prior-year quarter. Biopharma test volume was strong with first quarter totaling approximately 6,150 tests, up 21% from the prior-year quarter.

第一季度 Guardant360 平均售價接近我們預期範圍 2,600 美元至 2,700 美元的高端，這得益於商業付款人的組合和積極勢頭。混合臨床 ASP 約為 2,340 美元，略高於 2022 年第四季度的混合 ASP。提醒一下，混合臨床 ASP 將繼續受到 Guardant360、TissueNext、Reveal 和 Response 之間的體積組合以及整體組合的影響。美國和國際之間的臨床量。第一季度來自生物製藥測試的精準腫瘤學收入總計 2180 萬美元，比去年同期的 1810 萬美元增長 20%。生物製藥測試量強勁，第一季度總測試量約為 6,150 次，比去年同期增長 21%。

Biopharma ASP in the first quarter was approximately $3,550, which was in line with our expectations. Development services and other revenue in the first quarter totaled $15.3 million, up $3.4 million or 28% from the prior-year quarter, primarily driven by higher revenues and for partnership agreements in the first quarter of 2023.

第一季度生物製藥平均售價約為 3,550 美元，符合我們的預期。第一季度的開發服務和其他收入總計 1530 萬美元，比去年同期增長 340 萬美元或 28%，這主要是由於收入增加和 2023 年第一季度的合作協議。

Gross profit for the first quarter of 2023 was $75.6 million compared to gross profit of $64.1 million in the same period of the prior year. Gross margin was 59% compared to 67% in the prior-year quarter. The change in the gross margin was driven by a number of factors. For precision oncology, the gross margin was 60% in the first quarter of 2023 compared to 64% in Q1 2022. This reduction was due to the change in mix between clinical and biopharma revenue with clinical revenue growing faster than biopharma revenue as well as the year-over-year change in blended clinical ASP from $2,250 to $2,340 due to the increased proportion of volume coming from Reveal, TissueNext and Response.

2023 年第一季度的毛利潤為 7560 萬美元，上年同期為 6410 萬美元。毛利率為 59%，而去年同期為 67%。毛利率的變化是由多種因素驅動的。對於精準腫瘤學，2023 年第一季度的毛利率為 60%，而 2022 年第一季度為 64%。這一下降是由於臨床收入和生物製藥收入的組合發生變化，臨床收入增長快於生物製藥收入，以及由於來自 Reveal、TissueNext 和 Response 的銷量比例增加，混合臨床 ASP 的同比變化從 2,250 美元增加到 2,340 美元。

Development services and other gross margins, 48% in the first quarter of 2023, compared to 89% in Q1 2022. Roughly 1/3 of the decline in margin is due to a onetime cost incurred in Q1 2023 related to one of our partnership agreements, with the remainder of the decline due to the cost of processing Shield LDT samples as part of our market development activities for which we are currently booking many more revenue.

開發服務和其他毛利率，2023 年第一季度為 48%，而 2022 年第一季度為 89%。利潤下降的大約 1/3 是由於 2023 年第一季度發生的與我們的一項合作協議相關的一次性成本，其餘下降是由於處理 Shield LDT 樣品的成本作為我們市場開發活動的一部分，我們目前為此預訂了更多收入。

Despite the factors influencing our gross margins, we still continue to expect overall gross margins to be approximately 60% for the remainder of the year. Operating expenses for the first quarter of 2023 were $209.7 million, increasing 12% compared to $187.5 million in Q1 2022. Net loss was $133.5 million or $1.30 per share for the first quarter of 2023 compared to $123.2 million or $1.21 per share in the first quarter of 2022.

儘管存在影響我們毛利率的因素，我們仍然預計今年剩餘時間的整體毛利率約為 60%。 2023 年第一季度的運營費用為 2.097 億美元，與 2022 年第一季度的 1.875 億美元相比增長 12%。2023 年第一季度的淨虧損為 1.335 億美元或每股 1.30 美元，而第一季度為 1.232 億美元或每股 1.21 美元2022 年。

Moving on to non-GAAP financial measures on Slide 15. As a reminder, non-GAAP financial measures exclude stock-based compensation and related employee payroll tax payments, amortization of our intangible assets, contingent consideration, acquisition-related expenses and realized gains on marketable equity securities and the impairment of nonmarketable equity securities.

轉到幻燈片 15 的非 GAAP 財務指標。提醒一下，非 GAAP 財務指標不包括基於股票的薪酬和相關的員工工資稅支付、我們的無形資產攤銷、或有對價、收購相關費用和已實現收益有價證券和非有價證券的減值。

Non-GAAP operating expenses were $188.3 million for the first quarter of 2023, a 19% increase from $158.7 million in the prior-year quarter. Non-GAAP net loss was $108.5 million or $1.06 per share for the first quarter of 2023 compared to $93.2 million or $0.91 per share for the first quarter of 2022. Adjusted EBITDA was a loss of $101.0 million in the first quarter of 2023, compared to $86.6 million loss in the first quarter of 2022. We define adjusted EBITDA as non-GAAP net loss adjusted for interest, income tax, depreciation, amortization and other income and expense.

2023 年第一季度的非美國通用會計準則運營費用為 1.883 億美元，比去年同期的 1.587 億美元增長 19%。 2023 年第一季度非美國通用會計準則淨虧損為 1.085 億美元或每股 1.06 美元，而 2022 年第一季度為 9320 萬美元或每股 0.91 美元。調整後的 EBITDA 在 2023 年第一季度虧損 1.01 億美元，相比之下2022 年第一季度虧損 8660 萬美元。我們將調整後的 EBITDA 定義為根據利息、所得稅、折舊、攤銷和其他收入和費用調整的非 GAAP 淨虧損。

Taking a closer look at our operating expenses and cash burn on Slide 16. We've made very good progress with respect to meeting our target of reducing both our operating expenses and cash burn for the full year 2023. As mentioned, non-GAAP operating expenses in the first quarter of 2023 were $188 million and include approximately $8 million of onetime severance costs related to the recent workforce reduction.

在幻燈片 16 上仔細查看我們的運營費用和現金消耗。我們在實現 2023 年全年減少運營費用和現金消耗的目標方面取得了很好的進展。如前所述，非 GAAP 運營2023 年第一季度的支出為 1.88 億美元，其中包括與近期裁員相關的約 800 萬美元的一次性遣散費。

Excluding severance costs, this represents a reduction of approximately $21 million versus our non-GAAP operating expenses in Q4 2022. Our free cash outflow in the first quarter of 2023 was $82 million, which also declined in comparison to Q4 2022. These decreases were driven by efficiency measures implemented in the first quarter, including the workforce reduction as well as by our ability to leverage the infrastructure we've built over the last few years. While both operating expenses and cash burn levels could fluctuate up and down throughout the year, depending on the timing of certain activities and cash outflows, we will continue to diligently manage our spend with the goal of lowering our full year operating expenses compared to 2022 and reducing our free cash outflow to under $350 million for the full year.

不包括遣散費，這比我們 2022 年第四季度的非 GAAP 運營費用減少了約 2100 萬美元。我們在 2023 年第一季度的自由現金流出為 8200 萬美元，與 2022 年第四季度相比也有所下降。這些下降是由於通過第一季度實施的效率措施，包括裁員以及我們利用過去幾年建立的基礎設施的能力。雖然全年運營費用和現金消耗水平可能會上下波動，但取決於某些活動和現金流出的時間，我們將繼續努力管理我們的支出，目標是與 2022 年相比降低全年運營費用和將我們全年的自由現金流出減少到 3.5 億美元以下。

Turning to Slide 17. As I just mentioned, we demonstrated leverage in Q1 from infrastructure investments made in prior years and the recent workforce reduction, and as a result, ended the quarter with $937 million in cash, cash equivalents and marketable debt securities. As we look ahead, we will continue our progress towards breakeven and service selection, which we are targeting to achieve in the next 6 to 9 months.

轉到幻燈片 17。正如我剛才提到的，我們在第一季度展示了前幾年進行的基礎設施投資和最近裁員的槓桿作用，因此，本季度末現金、現金等價物和有價債務證券為 9.37 億美元。展望未來，我們將繼續在收支平衡和服務選擇方面取得進展，我們的目標是在未來 6 到 9 個月內實現這一目標。

At the same time, we will continue investing to maximize the large market opportunities [and principals]. In order to achieve this balance and fulfill our commitment to capital stewardship, we are leveraging a decade's worth of investments in scaling our core therapy selection platform, where we actively manage our growth investments to align with key milestones.

與此同時，我們將繼續投資以最大化巨大的市場機會[和本金]。為了實現這種平衡並履行我們對資本管理的承諾，我們正在利用十年的投資來擴展我們的核心治療選擇平台，我們在這個平台上積極管理我們的增長投資以與關鍵里程碑保持一致。

We are also gaining material leverage in therapy selection, thanks to our rapid volume growth and pay coverage expansion. As our core business in services selection reaches breakeven, our cash burn will be driven by our 2 major growth opportunities: MRD and screening. In 2023, MRD spend will continue to be focused on increasing market penetration, our technical platform upgrades and developing clinical data to support reimbursement coverage.

由於我們的銷量快速增長和薪酬覆蓋範圍擴大，我們還在治療選擇方面獲得了物質影響力。隨著我們在服務選擇方面的核心業務達到盈虧平衡，我們的現金消耗將由我們的 2 個主要增長機會推動：MRD 和篩選。 2023 年，MRD 支出將繼續專注於提高市場滲透率、我們的技術平台升級和開發臨床數據以支持報銷範圍。

As AmirAli mentioned, for screening, we are managing our spend very closely ahead of FDA approval. We anticipate that the operating loss from our screening pipeline will be less than $200 million over the next 12-month period. With this level of investment, we will be ready for the Shield IVD launch upon successful FDA approval, deliver the next generation of Shield with even better early-stage performance. We made significant progress on the indication expansion to lung cancer. Investments beyond this will be contingent on receiving FDA approval and then gated by ongoing commercial success and revenue milestones.

正如 AmirAli 提到的，對於篩選，我們在 FDA 批准之前非常密切地管理我們的支出。我們預計，在接下來的 12 個月內，我們篩選管道的運營損失將低於 2 億美元。有了這一水平的投資，我們將準備好在 FDA 成功批准後推出 Shield IVD，交付具有更好早期性能的下一代 Shield。我們在適應症擴展到肺癌方面取得了重大進展。超出此範圍的投資將取決於獲得 FDA 的批准，然後受到持續的商業成功和收入里程碑的限制。

Now turning to our outlook for the full year 2023 on Slide 18. We are raising our full year 2023 revenue guidance and now expect revenue to be in the range of $535 million to $545 million, representing growth of approximately 19% to 21% compared to 2022. This compares to our previous expectation of $525 million to $540 million.

現在轉向我們在幻燈片 18 上對 2023 年全年的展望。我們正在提高 2023 年全年收入指引，現在預計收入將在 5.35 億美元至 5.45 億美元之間，與去年同期相比增長約 19% 至 21%。 2022 年。這與我們之前預期的 5.25 億美元至 5.4 億美元相比。

This update reflects a very strong performance of our clinical business in the first quarter, healthy market dynamics and our continued confidence in our competitive strength. Finally, as previously discussed, we expect 2023 operating expenses to be below full year 2022 and free cash flow to improve to be approximately negative $350 million in 2023 and to consistently improve in the following years. Capital stewardship is a top priority for us, and we will deploy cash in line with key triggers such as regulatory approvals, clinical and R&D milestones and achievement of commercial goals.

此次更新反映了我們第一季度臨床業務的強勁表現、健康的市場動態以及我們對競爭實力的持續信心。最後，如前所述，我們預計 2023 年的運營支出將低於 2022 年全年，自由現金流將在 2023 年改善至約負 3.5 億美元，並在接下來的幾年中持續改善。資本管理是我們的首要任務，我們將根據監管批准、臨床和研發里程碑以及商業目標實現等關鍵觸發因素部署現金。

And finally, turning to Slide 19. Our long-term vision is to transform cancer diagnostics through cutting-edge technology, our focus on high-impact opportunities and consistent execution.

最後，轉到幻燈片 19。我們的長期願景是通過尖端技術、我們對高影響力機會和一致執行的關注來轉變癌症診斷。

At this point, we will now open up the call to questions.

在這一點上，我們現在將打開問題的電話。

(Operator Instructions) Our first question comes from Dan Arias from Stifel.

（操作員說明）我們的第一個問題來自 Stifel 的 Dan Arias。

I wanted to ask about resistance monitoring overall and the Response assay now that you've got the Medicare decision. Can you just talk about the volume contributions and the revenue contributions that we should think about near term, but also maybe a couple of quarters down the road as the assay ramps. And then as adoption for Response get going, do you see that being impactful to the G360 trajectory? It does seem like there are some off-label 360 usage for treatment response. So just curious if you think that's meaningful going forward. And then maybe, Mike, is there anything for Response in your revenue guide?

既然你已經做出了醫療保險決定，我想問一下總體耐藥性監測和反應分析。你能不能談談我們應該在近期考慮的銷量貢獻和收入貢獻，但也可能在未來幾個季度隨著檢測的增加而考慮。然後隨著 Response 的採用開始，您認為這對 G360 軌蹟有影響嗎？似乎確實有一些標籤外的 360 度用於治療反應。所以只是好奇你是否認為這對未來有意義。然後，Mike，您的收入指南中是否有關於 Response 的內容？

Yes. Thanks for the question. We're very pleased with the recent Medicare approval we got for Response. It's for the indication of immunotherapy for all solid tumors, which, as you know, is I think one of the really largest use cases in terms of oncology, in terms of the major classes therapeutics where Response can be difficult to assess. And this is really going to fill an important need.

是的。謝謝你的問題。我們對 Response 最近獲得 Medicare 批准感到非常高興。它用於所有實體瘤的免疫治療適應症，正如你所知，我認為這是腫瘤學中真正最大的用例之一，就難以評估反應的主要治療類別而言。這真的會滿足一個重要的需求。

Response is not a test that we've been pushing very strongly ahead of reimbursement. But now that we have Medicare reimbursement in hand, we're going to be pushing that a lot more aggressively. I would say that it's a really nice sort of kiosk of an initial Guardant360 test. It's a single test acquisition forum. There's a certain attachment rate. And so the 2 really go hand in hand with one another.

響應不是我們在報銷之前一直大力推動的測試。但現在我們手頭有醫療保險報銷，我們將更加積極地推動它。我會說這是一種非常好的初始 Guardant360 測試亭。這是一個單一的測試採集論壇。有一定的附著率。所以這兩個真的是齊頭並進的。

And this is just the beginning. We'll be increasing and attempting to collect more data. We have publications out there that show this test works in targeted -- for targeted therapies across multiple tumor types. And so we'll continue working with payers and certainly with MolDX in terms of trying to expand this further.

而這僅僅是個開始。我們將增加並嘗試收集更多數據。我們有出版物表明該測試有針對性——適用於多種腫瘤類型的靶向治療。因此，我們將繼續與付款人合作，當然也與 MolDX 合作，試圖進一步擴大這一範圍。

We'll also be pursuing ADLT status in terms of trying to move up the price as well. So I think we have both of those tailwinds and levers ahead of us. And I'll let Mike talk about the financials.

我們還將在嘗試提高價格方面追求 ADLT 地位。所以我認為我們前面有這些順風和槓桿。我會讓邁克談談財務狀況。

Yes, just on the revenue guide. At the start of the year, when we guided, we didn't have anything in -- for Response, but now we've got the Medicare reimbursement for the remainder of the year. We've added at this sort of guidance, but it's very sort of very low single-digit millions, so minimal contribution this year. I think we were looking at for 2024. But yes, a small amount in this revised guidance.

是的，就在收入指南上。在今年年初，當我們進行指導時，我們沒有任何回應——但現在我們已經獲得了今年剩餘時間的醫療保險報銷。我們已經添加了這種指導，但它是非常低的個位數數百萬，所以今年的貢獻很小。我認為我們正在尋找 2024 年的時間。但是，是的，在修訂後的指南中有少量。

Our next question comes from Puneet Souda from SVB Securities.

我們的下一個問題來自 SVB Securities 的 Puneet Souda。

Could you talk a little bit about the next-generation Shield for CRC? What do you need to do there? What are the next steps? When could that be potentially submitted to FDA? Obviously, you have a test that's at least, from a stage 2 to 4 is delivering at 100%, which was good to see. Then stage 1, it was 55%. So just maybe talk to us both on stage 1 and advanced adenoma improvement, sort of what's the time line of improving that and ultimately bringing this test to market.

您能談談用於 CRC 的下一代 Shield 嗎？你需要在那裡做什麼？什麼是下一個步驟？什麼時候可以提交給 FDA？顯然，您的測試至少從第 2 階段到第 4 階段以 100% 交付，這很高興看到。然後第一階段，是55%。因此，也許就第一階段和晚期腺瘤改善與我們談談，看看改善它並最終將這個測試推向市場的時間線是什麼。

Thanks, Puneet. So we are very pleased actually. We believe this first generation of Shield, the performance that we reported, is way above actually what's needed for FDA approval. CMS coverage is clear, and also commercial success of this brand. So we're going to take this first generation to the finish line, get the FDA approval for it and go to market with it.

謝謝，普尼特。所以我們實際上很高興。我們相信第一代 Shield，即我們報告的性能，遠高於 FDA 批准的實際要求。 CMS 的覆蓋面很明確，也為這個品牌帶來了商業上的成功。因此，我們將把第一代產品帶到終點線，獲得 FDA 的批准，並將其推向市場。

Having said that, Guardant always -- we have this philosophy of continuous improvement powered by data. And now this is going to be another showcase that the first generation of Shield is not going to be the best and the last of what can be done with blood testing and liquid biopsy. Through running ECLIPSE additional samples that we process, as I mentioned, our team figured out a specific soft class of very early-stage cases that we are missing. And the core technology is capable of potentially detecting more of these cases. It's just they were not represented very nicely in our development cohort before.

話雖如此，Guardant 始終——我們擁有這種由數據驅動的持續改進理念。現在這將是另一個展示，第一代 Shield 不會是最好的，也不會是血液檢測和液體活檢所能完成的最後一個。正如我提到的，通過運行我們處理的 ECLIPSE 額外樣本，我們的團隊找出了我們遺漏的非常早期案例的特定軟類。核心技術有能力檢測更多此類病例。只是他們之前在我們的開發隊列中並沒有很好地代表。

So we are pleased, we are excited with the progress we made. Still it's too early to mention a specific time line, and we want to make sure we take this first generation to the finish line, but shortly after, we are going to upgrade this device, and we are going to work with agency to upgrade it through potential sPMA routes to upgrade the claims.

所以我們很高興，我們對我們取得的進展感到興奮。現在提及具體的時間線還為時過早，我們希望確保將第一代產品帶到終點線，但不久之後，我們將升級該設備，我們將與代理商合作對其進行升級通過潛在的 sPMA 路線來升級索賠。

In terms of the routes, I think it's clear. As you know, in terms of upgradability, we have a bunch -- additional biobank samples that we have. That was a strategic move that we took at Guardant that ECLIPSE continued. We have many more CRCs, many more samples in our freezers, leftover from the first cohort, so we just need to process those samples. But let us make more progress and take this first generation to the finish line, and then we can talk about the second generation.

就路線而言，我認為很清楚。如您所知，就可升級性而言，我們有一堆——我們擁有的額外生物樣本庫樣本。這是我們在 Guardant 採取的一項戰略舉措，ECLIPSE 繼續進行。我們有更多的 CRC，我們的冰箱裡有更多的樣本，都是第一批剩餘的，所以我們只需要處理這些樣本。但是讓我們取得更多的進步，把這個第一代走到終點，然後我們再談第二代。

Got it. And one super quick question. Do you expect it to be annual test with the current first generation?

知道了。還有一個超級快速的問題。您是否希望對當前的第一代產品進行年度測試？

No, I think, one, you're looking, actually, at the rate of -- and I think it's really, like -- the biology of CRC when you look at events and some of the literature in terms of how long it takes for CRC to go from one stage to the next stage, based on some modeling, so you're going to see that, actually, a minority of stage are going to become, like, very late-stage advance for even, like, 3 years up there.

不，我認為，一個，實際上，當您查看事件和一些文獻時，您正在查看 CRC 的生物學速度——而且我認為這確實是這樣為了讓 CRC 從一個階段進入下一階段，基於一些模型，所以你會看到，實際上，少數階段會變成非常晚期的階段，甚至 3年在那裡。

So when you're looking into it that, really, at what intervals you need to run this test, we believe, as long as this test is getting done every 3 years with high compliance, you're going to detect almost all CRCs at curable age. That's why we are very excited with the potential of this device for CRC. But again, this doesn't mean that this would be the last performance. And I would bet you, over time, it's just going to continue to get better and better. It cannot get worse. The only way is make it better.

因此，當您研究它時，實際上，您需要以什麼時間間隔運行此測試，我們相信，只要該測試每 3 年進行一次並且高度合規，您將檢測到幾乎所有的 CRC可治愈年齡。這就是為什麼我們對該設備用於 CRC 的潛力感到非常興奮。但同樣，這並不意味著這將是最後一次演出。我敢打賭，隨著時間的推移，它會越來越好。它不會變得更糟。唯一的辦法就是讓它變得更好。

Our next question comes from Jack Meehan from Nephron Research.

我們的下一個問題來自 Nephron Research 的 Jack Meehan。

My first question is on the G360 ASP, so high end of the $2,600 to $2,700 range. Recently, you've had a big acceleration in terms of the covered lives and payer wins. Just curious, did you get better claims experience with some of these new payers? Do you think it's possible to outperform that range for the remainder of the year? Can you talk about what guidance assumes in terms of G360 ASP?

我的第一個問題是關於 G360 ASP，在 2,600 美元到 2,700 美元範圍內的高端。最近，您在承保人壽和付款人獲勝方面有了很大的加速。只是好奇，您是否從這些新付款人中獲得了更好的理賠體驗？您認為在今年剩餘時間內有可能超越該範圍嗎？您能否談談 G360 ASP 方面的指導假設？

Yes. Jack, it's Mike here. I can take this one. Yes, I mean, I think, first, the main driver of this improved ASP this quarter is really the mix between the CDx and the LDT versions of the test. And CDx is -- from Medicare, it's reimbursed at $5,000. The LDT at is at $3,500. So we've got a better ASP on the CDx version. And some of that's being driven by -- some of that mix towards the CDx is being driven by the FDA approvals that we've been getting over the last year or so. So I think that can continue positively.

是的。傑克，我是邁克。我可以拿這個。是的，我的意思是，我認為，首先，本季度改進 ASP 的主要驅動因素實際上是測試的 CDx 和 LDT 版本之間的混合。 CDx 是——來自 Medicare，報銷 5,000 美元。 LDT 為 3,500 美元。所以我們在 CDx 版本上有更好的 ASP。其中一些是由我們在過去一年左右獲得的 FDA 批准推動的——一些對 CDx 的混合。所以我認為這可以積極地繼續下去。

And then from the payer tailwinds, yes, I think as we start to see the claims come through, hopefully, we'll see positive momentum there, and it could lead to that going higher than $2,700. Our guidance at the moment just assumes this at $2,700 level. And so we'll see, but again, we've had really positive news over the last few months. And so that really bodes well for the remainder of the year.

然後從付款人的順風中，是的，我認為當我們開始看到索賠通過時，希望我們會在那裡看到積極的勢頭，這可能導致價格高於 2,700 美元。我們目前的指導只是假設這是 2,700 美元的水平。所以我們拭目以待，但在過去幾個月裡，我們又收到了非常積極的消息。因此，這對今年餘下的時間來說確實是個好兆頭。

Great. Okay. And then sticking with oncology, and with Reveal just on guidance. I think previously, you were targeting a low double-digit million contribution to sales. Can you talk about how you're tracking relative to that? And just how are the volumes building for Reveal? Any updates would be helpful.

偉大的。好的。然後堅持腫瘤學，並在指導下使用 Reveal。我認為以前，您的目標是對銷售額做出兩位數的低貢獻。你能談談你是如何追踪的嗎？ Reveal 的銷量如何？任何更新都會有所幫助。

Maybe I'll start and I'll let Mike come in. As you know, we've been sort of engineering our overall volume such that we focus on a lot of the reimbursed products. And yes, that strategy has been working extremely well. And so we've seen growth in categories with those products that are best reimbursed. That being said, we continue to see very strong growth in Reveal. I think we mentioned it was over 100% year-over-year. And so yes, I think we're very much on track. And Mike, do you have anything to add?

也許我會開始，我會讓邁克進來。如你所知，我們一直在設計我們的整體數量，以便我們專注於很多報銷產品。是的，該策略一直運作得非常好。因此，我們看到了那些報銷最好的產品類別的增長。話雖這麼說，我們繼續看到 Reveal 的強勁增長。我想我們提到過它比去年同期增長了 100% 以上。所以是的，我認為我們已經步入正軌。邁克，你有什麼要補充的嗎？

Yes. No. Yes, that we're on track. I think that number we mentioned of low double-digit millions, we're still on track for that, and that's still assumed in the current guide.

是的。不，是的，我們正在走上正軌。我認為我們提到的低兩位數百萬的數字，我們仍在朝著這個目標前進，並且在當前指南中仍然假設。

Our next question comes from Kyle Mikson with Canaccord.

我們的下一個問題來自 Canaccord 的 Kyle Mikson。

Congrats on the quarter. And I want to start on Reveal as well. Maybe help me, how sticky has Reveal been with clinicians and patients? Are you seeing a shift in more tests performed in that recurrent monitoring setting where you don't have a rate right now? And then also, if you could comment on timing of private or commercial payers and the other reimbursement for Medicare as well would be helpful.

祝賀這個季度。我也想從 Reveal 開始。也許可以幫助我，Reveal 對臨床醫生和患者的粘性如何？您是否看到在您現在沒有比率的定期監測環境中執行的更多測試發生了變化？然後，如果您可以評論私人或商業付款人的時間安排以及 Medicare 的其他報銷也會有所幫助。

Yes. So we're seeing, I think, a very similar mix to what we've been seeing. We've been focusing a lot more on reimbursed volumes. So it's the CRC indication and the adjuvant setting. So if anything, we've seen utilization in the -- kind of the -- sort of the existing indications continue to be strong. We're making excellent progress in terms of additional clinical data sets. We're hopeful that we'll still be on track to have some of those released later in the year. And once those gets published, assuming they're positive, we'll submit that for breast cancer and for the additional surveillance setting in CRC.

是的。所以我認為，我們看到的是與我們所看到的非常相似的組合。我們一直更加關注報銷量。所以這是 CRC 適應症和輔助設置。因此，如果有的話，我們已經看到現有跡象的使用率繼續保持強勁。我們在額外的臨床數據集方面取得了很好的進展。我們希望我們仍能按計劃在今年晚些時候發布其中的一些內容。一旦這些發表，假設它們是陽性的，我們將提交用於乳腺癌和 CRC 的額外監測設置。

Okay. That's perfect. And then AmirAli, just one on the kind of clips stated from earlier this morning, thanks for doing that call guys. In the DDW data on the stage 1 sensitivity included those 5 incompletely staged CRCs, if those were more advanced, you can -- in fact, those can move into stage 1, I guess, so you would have picked up more cancers.

好的。那很完美。然後是 AmirAli，只是今天早上早些時候所說的那種剪輯，感謝你們打電話給我。在第 1 階段敏感性的 DDW 數據中，包括那 5 個未完全分期的 CRC，如果它們更先進，你可以——事實上，我猜，那些可以進入第 1 階段，所以你會發現更多的癌症。

I know you're really conservative here, but would FDA and USPSTF take that kind of a nuance into account? Because, if you exact those out, overall sensitivity, stage 1 sensitivity would be much higher. So I'm just curious how they would sort of treat that aspect.

我知道你在這裡真的很保守，但 FDA 和 USPSTF 會考慮這種細微差別嗎？因為，如果你精確計算出這些，整體靈敏度，第 1 階段的靈敏度會高得多。所以我很好奇他們會如何對待這方面。

I'd just say a few words. I'd ask Craig to provide more details. Those malignant polyps are malignant. They are CRCs, but they are like so early stage, it looks like that even the patients are not going through the next step in terms of staging and the doctor thinks things they've done all the treatment required, but I'll let Craig to provide additional details.

我隨便說幾句。我會請 Craig 提供更多詳細信息。那些惡性息肉是惡性的。它們是 CRC，但它們處於早期階段，看起來即使是患者也沒有進行下一步的分期，醫生認為他們已經完成了所有需要的治療，但我會讓克雷格以提供更多詳細信息。

Thanks, AmirAli. It's Craig. One of the things to think through and when you get to assessing the data, it's about everyone's going to have a different perspective on these cases. And what we're providing is -- to the FDA and others is a transparency around how they were staged, and then how the malignant polyps were managed and not staged to use traditional criteria, HACC or the more histological basis.

謝謝，阿米爾阿里。是克雷格。當你開始評估數據時，需要仔細考慮的事情之一是，每個人都會對這些案例有不同的看法。我們提供的是——向 FDA 和其他人提供關於它們是如何分期的透明度，然後是如何管理惡性息肉而不是使用傳統標準、HACC 或更多組織學基礎進行分期。

How they're going to deal with that, that's something, obviously, we're going to work with them on and talk to them about, and we'll just have to see how that pans out. But it's quite clear that there are differences in the way they were staged, difference in the protocol, and these are things FDA, no doubt, will want to talk about.

他們將如何處理這個問題，顯然，我們將與他們合作並與他們討論，我們只需要看看結果如何。但很明顯，它們的上演方式不同，協議也不同，毫無疑問，這些都是 FDA 想要討論的事情。

Our next question comes from Julia Qin from JPMorgan.

我們的下一個問題來自摩根大通的 Julia Qin。

So AmirAli, regarding the under $200 million spend on Shield over the next 12 months, could you give us a sense of what's the rough spill between commercial and R&D, including loan expansion and then the next-generation test development? And does that include a potential step-up investment once you receive FDA approval, which I assume is within the next 12-month window? And how would you characterize this efficiency in commercial investment in that $200 million budget, especially given that we know sales and marketing plays a pretty important role in driving adoption?

那麼 AmirAli，關於未來 12 個月內在 Shield 上的不到 2 億美元的支出，您能否告訴我們商業和研發之間的粗略溢出是什麼，包括貸款擴張和下一代測試開發？一旦您獲得 FDA 批准，這是否包括潛在的升級投資，我認為這是在下一個 12 個月的窗口內？您如何描述 2 億美元預算中商業投資的這種效率，特別是考慮到我們知道銷售和營銷在推動採用方面發揮著非常重要的作用？

Yes. Thank you. So we believe, with this level of investment, actually, we are adequately resourced to really have a successful IVD launch that definitely includes the sales and marketing resources to launch this product. It's not that right after, we are going to increase our spend significantly on the S&M side. Actually, it's all embedded in that number. And it's going to be around that until we make more progress, actually, that some of our R&D kind of activities would kind of taper down in terms of some of these studies would end and so forth.

是的。謝謝。因此，我們相信，有了這種投資水平，實際上，我們有足夠的資源真正成功推出 IVD，其中肯定包括推出該產品的銷售和營銷資源。不是在那之後，我們將大幅增加在 S&M 方面的支出。實際上，它都包含在該數字中。實際上，在我們取得更多進展之前，我們的一些研發活動會逐漸減少，因為其中一些研究會結束等等。

So in terms of the split of that $200 million, still we are kind of heavy on the R&D side, just based on the trials that we are doing, some of the technology improvements that I talked about and some of the infrastructure that we are building to be able to really be able to handle the samples at scale with low cost and so forth.

因此，就那 2 億美元的分配而言，我們在研發方面仍然有點沉重，只是基於我們正在進行的試驗、我談到的一些技術改進以及我們正在建設的一些基礎設施能夠真正能夠以低成本大規模處理樣品等等。

So still, it's really R&D-heavy, but there are reasonable amounts of, actually, sales and marketing, very reasonable amount that we believe is -- we're adequate enough to have a successful FDA launch for this product. And as we make, actually, more revenues and we meet the milestones on increasing the ASP and getting the revenue coming with kind of the volumes that we expect, we are going to manage our operating expense.

所以，它仍然是研發密集型的，但實際上有合理數量的銷售和營銷，我們認為非常合理的數量——我們足以讓 FDA 成功推出該產品。實際上，隨著我們賺取更多的收入，並且我們達到了增加 ASP 的里程碑，並獲得了我們預期的收入，我們將管理我們的運營費用。

Keep in mind, as I mentioned in the prior calls, we believe you can have much higher efficiency running the S&M for a blood-based screening test, especially for us that we would be first mover in a completely new category. Frankly, in this new category, it's not that we are competing with other players based on what we are seeing in LDT. We are going to have that first-mover advantage in terms of market penetration. And already, we shaped the market a little bit to -- based on the accounts that we are in, that we feel confident that, actually, post FDA approval, we are going have a successful launch with this level of investment that I mentioned earlier.

請記住，正如我在之前的電話中提到的那樣，我們相信您可以更有效地運行 S&M 進行基於血液的篩查測試，特別是對我們來說，我們將成為一個全新類別的先行者。坦率地說，在這個新類別中，我們並不是根據我們在 LDT 中看到的內容與其他玩家競爭。我們將在市場滲透方面擁有先發優勢。我們已經對市場進行了一些調整——根據我們的賬戶，我們有信心，實際上，在 FDA 批准後，我們將以我之前提到的這種投資水平成功推出.

Our next question comes from Dave Delahunt from Golden Sachs.

我們的下一個問題來自 Golden Sachs 的 Dave Delahunt。

Julia actually took part of my question on the sales and marketing. And if you guys could give us a little bit more color on the sales force ramp and the strategy for calling on all the PCPs across the country, if you're thinking about any other type of media campaigns or anything to get in touch with these PCPs and get Shield out there and there and get its patients?

朱莉婭實際上回答了我關於銷售和營銷的部分問題。如果你們能給我們更多的關於銷售人員坡道和召集全國所有 PCP 的策略的顏色，如果你們正在考慮任何其他類型的媒體活動或任何與這些取得聯繫的事情PCP 並讓 Shield 在那里和那裡得到它的病人？

Yes. Again, actually, at the time of FDA approval and shortly after that, for a few quarters after even FDA approval, we are not expecting that we are going to have a very large sales force in terms of what we need to have for national coverage. At the end, like I said, as we are getting to USPS time lines, our commercial team, as I talked about before, potentially, it was going to be about 700, 800 people.

是的。再一次，實際上，在 FDA 批准時以及之後不久，甚至在 FDA 批准後的幾個季度裡，我們並不期望我們將擁有一支非常龐大的銷售隊伍，就我們需要擁有的全國覆蓋範圍而言.最後，就像我說的，當我們到達 USPS 時間表時，我們的商業團隊，正如我之前所說，可能會有大約 700、800 人。

But at the time of FDA launch and in a few quarters after that, it's going to be a timing fraction of the number that I mentioned. And we believe in our strategy based on actually what we are seeing in the market right now and the depth of ordering that we are seeing for the blood-based cancer screening. So when you look at the depth of ordering, when you look at actually a higher efficiency selling, that because of patient adherence, more than 90% of sold tests would get converted to [b-level] case versus for other modalities. It's a very leaky process, frankly.

但在 FDA 啟動時以及之後的幾個季度內，這將是我提到的數字的一小部分。我們相信我們的戰略基於我們目前在市場上看到的實際情況以及我們看到的基於血液的癌症篩查的訂購深度。因此，當您查看訂購的深度時，當您實際查看效率更高的銷售時，由於患者的堅持，超過 90% 的銷售測試將轉換為 [b 級] 案例，而不是其他方式。坦率地說，這是一個非常有漏洞的過程。

This gives us confidence that in order to meet the revenue milestones that we have in mind, we don't need to go to hundreds and hundreds of people in the commercial team. We can really do it very efficiently. And we will execute and we will show that this is possible. But definitely, in terms of our OpEx, it's not that we get FDA approval and we are going to ramp it up significantly. We are going to meet some revenue milestones. And step-by-step, milestone-driven, we would increase our investment justified by the revenues that we are seeing, and we will manage our contributing operating loss accordingly, very close to the number I mentioned earlier.

這讓我們有信心，為了實現我們心中的收入里程碑，我們不需要去接觸商業團隊中的數百人。我們真的可以非常有效地做到這一點。我們將執行並證明這是可能的。但可以肯定的是，就我們的運營支出而言，並不是我們獲得了 FDA 的批准，而是我們將大幅提高它。我們將達到一些收入里程碑。一步一步，以里程碑為導向，我們將根據我們所看到的收入增加我們的投資，我們將相應地管理我們的貢獻運營損失，非常接近我之前提到的數字。

Our next question comes from Mark Massaro from BTIG.

我們的下一個問題來自 BTIG 的 Mark Massaro。

Congrats on the strong quarter. My first question is for you, Helmy. When we think about the portfolio of therapy selection, obviously, you guys are the strong market leader in blood. As you're gaining additional traction with Guardant Response and TissueNext, 360 and then Reveal, to what extent do you think you can start moving perhaps some other competitive assays onto the platform by -- through bundling? And then I wanted to get a sense if you have a ballpark of what the attachment rate is between 360 and some of the other tests.

祝賀強勁的季度。我的第一個問題是問你的，Helmy。當我們考慮治療選擇組合時，顯然，你們是血液領域強大的市場領導者。隨著您通過 Guardant Response 和 TissueNext、360，然後是 Reveal 獲得更多關注，您認為您可以在多大程度上開始將其他一些競爭性檢測方法轉移到平台上——通過捆綁？然後我想知道您是否大致了解 360 和其他一些測試之間的依戀率。

So we have this, essentially, ecosystem of tests now where we can really manage the complete interaction from a precision oncology point of view that an oncologist has with their patients. And a lot of this will fall into place further as we move to the smart liquid biopsy platform where it'll really make the sort of data connection between the different pieces much more powerful and then increase the utility.

因此，從本質上講，我們現在擁有這個測試生態系統，我們可以從腫瘤學家與患者的精確腫瘤學角度真正管理完整的交互。隨著我們轉向智能液體活檢平台，其中很多將進一步落實到位，在該平台上，它將真正使不同部分之間的數據連接更加強大，然後增加實用性。

But we're already seeing that right now, we're going through this evolution. We call this Guardant Complete, where, essentially, a physician can push 1 button and really get a sort of testing workflow that they request in place for their patients. And so if they want to start with liquid and reflex the issue, if they want a Response test after the patient's put on immunotherapy, all of that can be managed seamlessly now. And so we're really turning a lot of those features on.

但我們現在已經看到了這一點，我們正在經歷這種演變。我們稱之為 Guardant Complete，基本上，醫生可以按下一個按鈕，真正獲得他們為患者請求的一種測試工作流程。因此，如果他們想從液體開始並反映問題，如果他們想在患者接受免疫治療後進行反應測試，那麼所有這些現在都可以無縫管理。所以我們真的開啟了很多這些功能。

I don't think we've broken out the attachment rates, but we've seen very strong, I would say, connectivity between our tissue test and our blood test in terms initial Guardant360 test as well as Response tests. So it's working. It's why -- I think one of the strongest leverage points we have is the fact that our Guardant360 business itself, which is that first test, is growing very, very rapidly.

我不認為我們已經打破了附著率，但我想說，我們的組織測試和血液測試之間的連接性非常強，就初始 Guardant360 測試和響應測試而言。所以它的工作。這就是為什麼 - 我認為我們擁有的最強大的槓桿點之一是我們的 Guardant360 業務本身，這是第一個測試，正在非常非常迅速地增長。

We're, actually, we believe, taking market share -- not just growing, but taking market share from other companies. And everything else is a function that get attached or connected to that initial time point. So it's -- we're feeling very good going forward, and it's an exciting time for us.

實際上，我們相信，我們正在奪取市場份額——不僅僅是增長，而且是從其他公司那里奪取市場份額。其他一切都是附加或連接到該初始時間點的功能。所以它 - 我們感覺非常好，這對我們來說是一個激動人心的時刻。

Great. And maybe one for AmirAli. Obviously, the stage 1 through 3 sensitivity at 81% certainly exceeds the FIT test. And -- but I wanted to get a sense, obviously, stages 2 through 4 were excellent at 100%. To what extent should we look at the 55% and just wonder what the uptake of the test will be in light of the incredible sensitivity at stage 2 where it is surgically resectable? Just give us a sense for how to think about the numbers overall.

偉大的。也許是給 AmirAli 的。顯然，81% 的階段 1 到 3 靈敏度肯定超過了 FIT 測試。並且 - 但我想了解一下，顯然，第 2 階段到第 4 階段在 100% 時非常出色。我們應該在多大程度上關注這 55%，並想知道鑑於在可手術切除的第 2 階段具有令人難以置信的敏感性，該測試的採用情況如何？讓我們了解如何整體考慮這些數字。

So I'll maybe make a few points about this. So number one, bear in mind, we are talking about a new market category here for the people who are delaying or refusing to get any kind of screening done at this time. So for those patient population who are not participating in any modality of screening, I think we need to have the right perspective in terms of, like, they are not FIT done, they are not getting other stool tests done, they are not getting colonoscopy done.

所以我可能會就此提出幾點意見。因此，首先，請記住，我們在這裡談論的是一個新的市場類別，適用於此時推遲或拒絕進行任何類型篩查的人。因此，對於那些沒有參與任何篩查方式的患者群體，我認為我們需要有正確的觀點，比如，他們沒有進行 FIT，他們沒有進行其他糞便檢查，他們沒有進行結腸鏡檢查完畢。

The most important thing and actually what we heard also, in the call that we coordinated with experts, opinion leaders in the field is -- the most important factor is making sure the uptake of the test is proper and patient participation is adequate, and blood test has that kind of advantage. So that's why I don't think necessarily, like, kind of comparative numbers is the most important factor here in terms of adoption.

最重要的事情，實際上我們也聽到了，在我們與專家、該領域的意見領袖協調的電話會議中——最重要的因素是確保測試的採用是適當的，患者的參與是充分的，血液測試具有這種優勢。所以這就是為什麼我認為就採用而言，比較數字不一定是這裡最重要的因素。

Number two, in terms of what data actually -- which data should we look at. I look at what level we are going to get FDA approval, we are going to get Medicare coverage. We are going to generate access for all patients who are eligible for this test. And those numbers are clear. We know it. you know it. Like, our test performance is -- what we've reported is way over those minimum requirements.

第二，就實際數據而言——我們應該查看哪些數據。我看看我們將獲得 FDA 批准的級別，我們將獲得 Medicare 保險。我們將為所有符合此測試條件的患者提供訪問權限。這些數字很清楚。我們知道。你知道的。就像，我們的測試性能是——我們所報告的遠遠超過了這些最低要求。

When we go to early stage, I think we have to keep in mind, when you cut the data into smaller pieces, like, there are some statistical variation associated with it just from scientific mentality. But if you just look at these numbers in its face value, it's exciting to see you're detecting all cancers at stage 2, at stage 3 and let's say, half of stage 1 for the patients who are not getting screened and they don't have any symptom.

當我們進入早期階段時，我認為我們必須記住，當您將數據分成更小的部分時，例如，從科學的角度來看，會有一些與之相關的統計變異。但如果你只看這些數字的表面價值，很高興看到你在第 2 階段、第 3 階段檢測到所有癌症，比方說，對於未接受篩查的患者，第 1 階段的一半沒有任何症狀。

What fraction of the missed stage 1s are going to become stage 4, 3 years after? When you look at it, it's a minority. So in a longitudinal test, for a test that patient adhere to, which is not applicable to other modalities, this kind of test performance, on its face value, it's kind of exciting, and that's why we believe it would detect nearly all CRCs at curable stage and would save many lives.

3 年後，錯過的第 1 階段有多少會進入第 4 階段？當你看它時，它是少數。所以在縱向測試中，對於患者堅持的測試，不適用於其他模式，這種測試性能，從表面上看，有點令人興奮，這就是為什麼我們相信它會檢測到幾乎所有的 CRC可治癒的階段，將挽救許多生命。

Our next question comes from Derik De Bruin from Bank of America.

我們的下一個問題來自美國銀行的 Derik De Bruin。

This is John on for Derik. So last quarter in biopharma, you guys were seeing some headwinds with some clients delaying their decisions. Has there been any improvement? And obviously, you spoke of your strong back -- strong order book. So I was wondering how that's balancing out with your order book. And in terms of -- in Japan, how are the conversations going in terms of getting that reimbursement finally?

這是約翰替德里克。所以上個季度在生物製藥領域，你們看到了一些不利因素，一些客戶推遲了他們的決定。有沒有改善？顯然，你談到了你強大的後盾——強大的訂單簿。所以我想知道這與您的訂單簿是如何平衡的。就-在日本而言，關於最終獲得報銷的對話進展如何？

Yes. No, so I think when we mentioned that we -- on the biopharma side, I think there is potential for some headwinds. We haven't necessarily seen them affect our business considerably. And we're obviously doing extremely well in terms of biopharma volume. We're happy where things are. We're happy with what the pipeline looks like. We do think that as we said that some of that will resolve, we have some of the uncertainty around budgets and some of them will resolve second half of this year.

是的。不，所以我認為當我們提到我們——在生物製藥方面時，我認為可能會遇到一些不利因素。我們不一定看到它們對我們的業務產生重大影響。而且我們在生物製藥量方面顯然做得非常好。我們很高興事情在哪裡。我們對管道的外觀感到滿意。我們確實認為，正如我們所說，其中一些會得到解決，但我們在預算方面存在一些不確定性，其中一些將在今年下半年得到解決。

And we are seeing a lot of very encouraging conversations we're having with pharma companies across multiple programs. So we think this is going to continue to be an important growth driver for our business. In terms of Japan, we're having good conversations there. And yes, we still think we're on track for this year to have a reimbursement there, and that'll be a big business for us. And I'll just add, I think -- we're making good progress in China as well. And we think that'll also be a similarly strong business for us once that gets going.

我們看到我們在多個項目中與製藥公司進行了很多非常令人鼓舞的對話。因此，我們認為這將繼續成為我們業務的重要增長動力。就日本而言，我們在那裡進行了很好的對話。是的，我們仍然認為我們今年有望在那裡獲得報銷，這對我們來說將是一項大生意。我想補充一點——我們在中國也取得了很好的進展。我們認為，一旦開始，這對我們來說也將是一項同樣強大的業務。

Our final question comes from Tejas Savant from Morgan Stanley.

我們的最後一個問題來自摩根士丹利的 Tejas Savant。

One for you, Helmy, on the Guardant response testing protocol. Can you just lay out, in your mind, like, what do you think are the advantages of measuring just those 2 time points over the course of IO versus tracking the patient over a longer period of time via multiple follow-up tests? I mean, for example, if a physician wants to look at that continue/discontinue decision a little bit later, how would that work? Or is it relatively rare to use an assay in that fashion right now?

Helmy，關於 Guardant 響應測試協議的一個給你的。您能否在腦海中列出，例如，您認為在 IO 過程中僅測量這 2 個時間點與通過多次後續測試在較長時間內跟踪患者相比有什麼優勢？我的意思是，例如，如果醫生想稍後查看繼續/停止決定，那將如何工作？還是現在以這種方式使用檢測相對較少？

Yes. If you look at the literature, including other tests that are out there. A lot of the clinical utility, almost amongst all of it really derives from the initial time point post treatment initiation. And so that's really the benefit. If you wait out longer, then you're -- essentially, you can start relying on other approaches, radiographic imaging and so on. So it's -- we don't think that you're missing out by using kind of that time point. And it's really focusing on what the data shows and where the clinical utility is.

是的。如果您查看文獻，包括那裡的其他測試。許多臨床效用，幾乎在所有臨床效用中，都真正源自治療開始後的初始時間點。這就是真正的好處。如果你等待的時間更長，那麼你 - 基本上，你可以開始依賴其他方法，放射成像等。所以它 - 我們認為您不會因為使用那個時間點而錯過任何機會。它真正關注的是數據顯示的內容以及臨床效用所在。

That doesn't mean that there may be use cases in the future where monitoring may be beneficial. Obviously, that's where the field is going as extensive monitoring. But we don't see much sort of -- almost any loss in sort of utility or value. But in fact, it's nicer to just -- to know that with a single test, you can help make a decision.

這並不意味著將來可能會有監視有益的用例。顯然，這就是該領域作為廣泛監測的方向。但我們沒有看到太多——幾乎沒有任何效用或價值方面的損失。但事實上，更好的做法是——知道通過一次測試，您可以幫助做出決定。

Got it. That's helpful. And then one quick one for AmirAli here. AmirAli, with ECLIPSE sort of full staging sort of now available, how does the CRC mix, by stage, compared with your previous a priori expectations, if you will? We had a few inbounds on more stage 4 patients in ECLIPSE versus DeePC, et cetera. Were there any differences in trial design, in retrospect, that may have contributed to the differences in the mix for the population enrolled?

知道了。這很有幫助。然後這裡是 AmirAli 的一個快速的。 AmirAli，現在有了 ECLIPSE 類的完整分期，CRC 如何按階段混合，與您之前的先驗期望相比，如果您願意的話？在 ECLIPSE 和 DeePC 等方面，我們有更多的 4 期患者入站。回想起來，試驗設計中是否存在任何差異，這可能導致登記人群的組合差異？

So maybe I make a few statements, then I ask Craig to chime in here. So in fact, when you look at public databases on, like, the staging distribution of recently diagnosed CRC patients, it's actually pretty close. Like, I think if I recall right, for stage 4, it's about 20% of the patients are getting diagnosed at stage 4. And in 65 patients in this cohort, we had 10, so it's kind of pretty close. But Craig, do you want to add…

所以也許我發表了一些聲明，然後我請克雷格在這裡插話。所以事實上，當你查看公共數據庫時，比如最近診斷出的 CRC 患者的分期分佈，它實際上非常接近。就像，我想如果我沒記錯的話，對於第 4 階段，大約 20% 的患者在第 4 階段被診斷出來。在這個隊列中的 65 名患者中，我們有 10 名，所以它有點接近。但是克雷格，你想補充……

Yes, I might add. I mean, we're talking about small numbers when you compare across trials, number one. Also a time difference for those trials you talked about, and our study collected a diverse U.S. population, so it's really at that point in time. And you can start to get into theories about what's different between a population from 2019 to 2022, versus 2012 to 2014. And obviously, one thing that would make a nice story is COVID, and people talk about the delay in screening and other things. But as AmirAli mentioned, when you look at the actual stage 4 breakdown, it's actually pretty much spot on to where things we'd expect from other databases in the population, so.

是的，我可能會補充。我的意思是，當你比較試驗時，我們談論的是小數字，第一。還有你提到的那些試驗的時間差，我們的研究收集了不同的美國人口，所以它確實是在那個時間點。你可以開始研究 2019 年到 2022 年的人口與 2012 年到 2014 年的人口之間有什麼不同的理論。很明顯，一個可以成為一個好故事的事情是 COVID，人們談論篩查和其他事情的延遲。但正如 AmirAli 所提到的，當你查看實際的第 4 階段細分時，它實際上非常準確地指出了我們對人口中其他數據庫的期望，所以。

Thank you. That was the end of the Q&A session, and this concludes today's call. Thank you, everyone, for joining us today. You may now disconnect.

謝謝。問答環節到此結束，今天的電話會議到此結束。謝謝大家今天加入我們。您現在可以斷開連接。