Guardant Health Inc (GH) 2023 Q4 法說會逐字稿

Good afternoon. Thank you for attending the Guardant Health Q4 2024 earnings call. My name is Victoria and I'll be your moderator today.

午安.感謝您參加 Guardant Health 2024 年第四季財報電話會議。我叫維多利亞，今天我將擔任你們的主持人。

(Operator Instructions) I would now like to pass the conference over to your host, Carrie Mendivil. Thank you. You may proceed, Carrie.

（操作員指示）我現在想將會議轉交給主持人 Carrie Mendivil。謝謝。你可以繼續了，嘉莉。

Thank you. Earlier today, Guardant Health released financial results for the quarter and year ended December 31, 2023. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer.

謝謝。今天早些時候，Guardant Health 發布了截至 2023 年 12 月 31 日的季度和年度財務業績。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·貝爾。

Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal security flaws. 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, which are adjusted to exclude certain specified items.

在我們開始之前，我想提醒您，在這次電話會議中，管理層將就聯邦安全缺陷做出前瞻性聲明。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。這次電話會議也將討論非公認會計準則財務指標，這些指標經過調整以排除某些特定項目。

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 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. The information in this conference call is accurate only as of the 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 財務指標的調節，請參閱 Guardant 今天發布的新聞稿以及我們向 SEC 提交的 10-K 表格和其他文件。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在廣播時準確。

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, Carrie. Good afternoon, and thank you for joining our fourth quarter and full year 2023 earnings call. I will start off our call today by providing an update on our progress over 2023 and go into more detail across 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 2024.

謝謝，嘉莉。下午好，感謝您參加我們的 2023 年第四季和全年財報電話會議。我將在今天的電話會議開始時介紹我們 2023 年進展的最新情況，並詳細介紹治療選擇和 MRD 方面的更多細節。然後我會將電話轉給阿米拉利，以了解篩檢的最新情況。最後，Mike 將更詳細地介紹我們的 2024 年財務狀況和前景。

Starting on slide three, we made substantial progress in each area of our business throughout the year, starting with therapy selection. After years of investing in our infrastructure, I'm very pleased that therapy selection reached cash flow breakeven at the end of the year, marking a major achievement for Guardant.

從幻燈片三開始，我們從治療選擇開始，全年在各個業務領域都取得了實質進展。經過多年對基礎設施的投資，我很高興治療選擇在年底達到了現金流收支平衡，這標誌著 Guardant 的一項重大成就。

This follows a series of pivotal reimbursement wins throughout 2023. We now have coverage from all major US commercial health insurers for Guardant360, surpassing 300 million covered lives. We also surpassed 200 million covered lives for TissueNext, received national reimbursement in Japan for Guardant360, and received Medicare reimbursement for Guardant Response. We also exceeded 475 EMR integrated accounts as of year end, outpacing our prior targets.

在此之前，我們在 2023 年取得了一系列關鍵的報銷勝利。現在，我們已獲得美國所有主要商業健康保險公司的 Guardant360 承保，覆蓋人數超過 3 億。我們還為 TissueNext 提供了超過 2 億的覆蓋生命，為 Guardant360 獲得了日本國家報銷，並為 Guardant Response 獲得了 Medicare 報銷。截至年底，我們的 EMR 綜合帳戶數量還超過了 475 個，超出了我們先前的目標。

Moving on to MRD. I'm excited to share that we upgraded reveal to the Smart Liquid Biopsy Platform at the end of the year, enabling even better performance. Reveal volumes came in strong with full-year growth of over 90%. We also received additional commercial coverage for Reveal in CRC following medicare reimbursement in 2022, and continued to produce compelling data across CRC and breast cancer for Reveal, demonstrating high clinical performance.

繼續 MRD。我很高興與大家分享，我們在今年年底將 Reveal 升級到了智慧液體活檢平台，從而實現了更好的性能。展示量強勁，全年成長超過 90%。在 2022 年醫療保險報銷後，我們還獲得了 Reveal 在 CRC 中的額外商業承保，並繼續為 Reveal 提供有關 CRC 和乳腺癌的令人信服的數據，證明了其較高的臨床表現。

And finally, with screening, we completed our PMA submission for Shield CRC, made steady progress with FDA review, and published the first paper for Shield demonstrating improved adherence with blood-based CRC screening. While we continue to believe the performance of Shield meets the bar for FDA approval, we have already demonstrated improved clinical sensitivity with our upgraded platform, Shield V2, when compared to Shield V1, with data presented at our Investor Day last year. I'm so proud of our team for pushing the boundaries of what's possible as we deliver on our bold mission to give everyone more time free from cancer.

最後，透過篩檢，我們完成了 Shield CRC 的 PMA 提交，在 FDA 審查中取得了穩步進展，並發表了第一篇 Shield 論文，證明了對基於血液的 CRC 篩檢的依從性有所提高。雖然我們仍然相信 Shield 的性能符合 FDA 批准的標準，但去年投資者日公佈的數據顯示，與 Shield V1 相比，我們升級後的平台 Shield V2 的臨床敏感性有所提高。我為我們的團隊感到非常自豪，他們在實現我們大膽的使命時突破了可能的界限，讓每個人都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 Reveal test has had on patients. In early 2023, a woman was diagnosed with triple negative breast cancer and underwent surgery. Her physician then ordered a series of Reveal tests as part of her surveillance program, and the second test came back positive for ctDNA 30 weeks after surgery.

根據這個使命，我想分享一個關於我們的 Reveal 測試對患者產生影響的故事。2023 年初，一名女性被診斷出患有三陰性乳癌並接受了手術。作為監測計劃的一部分，她的醫生隨後要求進行一系列 Reveal 測試，手術後 30 週第二次測試結果顯示 ctDNA 呈陽性。

The physician scheduled the patient for additional scans, which found a growing nodule in her lower left lung. With this discovery, she is now undergoing further treatment. This story highlights how Reveal can be used effectively in surveillance settings to identify the need for additional treatment and deliver better patient outcomes.

醫生安排患者進行額外的掃描，結果發現她的左下肺有一個不斷增大的結節。有了這項發現，她現在正在接受進一步的治療。這個故事強調如何在監測環境中有效地使用 Reveal 來確定是否需要額外的治療並提供更好的患者治療結果。

Turning to top-line performance in slide four, we had a strong finish to the year with revenue growing 22% to $155 million in the fourth quarter, and 25% to $564 million for the full year 2023, coming in slightly above our pre-announced range provided in January.

轉向第四張投影片中的營收表現，我們今年的業績表現強勁，第四季營收成長22%，達到1.55 億美元，2023 年全年營收成長25%，達到5.64 億美元，略高於我們先前的預期。

Turning to slide five, clinical test volume reached 46,400 tests in the fourth quarter and 172,900 tests for the full year 2023, up 29% and 39%, respectively, compared to the prior year periods. Guardant360has been the primary driver of clinical volume growth as we continue to enhance the customer experience with increasing contributions from newer products such as TissueNext and Response.

轉向投影片 5，第四季臨床試驗量達到 46,400 次，2023 年全年臨床試驗量達到 172,900 次，與去年同期相比分別成長 29% 和 39%。Guardant360 一直是臨床數量成長的主要驅動力，我們透過 TissueNext 和 Response 等新產品的貢獻不斷增強客戶體驗。

Moving on to biopharma on slide six, biopharma test volume reached 9,500 tests in the fourth quarter and 29,900 tests for the full year 2023, up 16% and 15%, respectively, compared to the prior year periods. A major driver of this growth has been the increasing interest in our Guardant Infinity smart liquid biopsy platform, which now represents more than 30% of our biopharma testing volume and has become a major differentiator for our biopharma business.

轉到第六張投影片上的生物製藥，生物製藥測試量在第四季達到 9,500 次測試，2023 年全年達到 29,900 次測試，與去年同期相比分別成長 16% 和 15%。這一成長的主要動力是人們對我們的Guardant Infinity 智慧液體活檢平台越來越感興趣，該平台目前占我們生物製藥測試量的30% 以上，並已成為我們生物製藥業務的主要差異化因素。

Looking forward, our robust companion diagnostic pipeline, coupled with a backlog of deals won, positions us for continued growth in 2024. We believe our active engagement with biopharma leaders for strategic partnerships, especially in exploring the potential of epigenomics, will drive even more demand for our products and services.

展望未來，我們強大的伴隨診斷管道，加上贏得的積壓交易，使我們能夠在 2024 年實現持續成長。我們相信，我們與生物製藥領導者積極建立策略夥伴關係，特別是在探索表觀基因組學的潛力方面，將推動對我們產品和服務的更多需求。

Now, looking more closely at some of the recent highlights within our therapy selection business on slide seven. We made great strides in improving ASPs for Guardant360 over the last few quarters. Specifically, in November, Medicare finalized this proposal for the Guardant360 LDT price to be crosswalked to the price of Guardant360 CDx.

現在，更仔細地觀察第七張幻燈片上我們的治療選擇業務中最近的一些亮點。過去幾個季度，我們在提高 Guardant360 的 ASP 方面取得了長足進步。具體來說，11 月，Medicare 敲定了 Guardant360 LDT 價格與 Guardant360 CDx 價格交叉的提案。

This took effect from January 1, of this year, increasing the Medicare price for Guardant360 LDT from $3,500 to $5,000. We're also starting to see the positive impact on Guardant360 ASP from commercial payer coverage wins and believe that this is a tailwind that will continue to play out in the coming year. As a result, we expect that in the first quarter of 2024, the Guardant360 ASP will increase to be in the range of $2,850 to $2,900.

該規定從今年 1 月 1 日起生效，將 Guardant360 LDT 的 Medicare 價格從 3,500 美元提高到 5,000 美元。我們也開始看到商業付款人覆蓋範圍的勝利對 Guardant360 ASP 的積極影響，並相信這將在未來一年繼續發揮作用。因此，我們預計 2024 年第一季度，Guardant360 的平均售價將上漲至 2,850 美元至 2,900 美元之間。

Turning to slide eight, we are focused on streamlining the customer experience and investing in our commercial infrastructure. To that end, we continue to make excellent progress integrating with the three largest oncology EMR systems with rapid growth of digital adoption. We believe these integrations will serve as a catalyst for increasing ordering depth for account throughout the year.

轉向幻燈片第八，我們專注於簡化客戶體驗並投資我們的商業基礎設施。為此，隨著數位化應用的快速增長，我們在與三大腫瘤 EMR 系統的整合方面繼續取得了巨大進展。我們相信這些整合將成為全年增加訂單深度的催化劑。

Another critical growth driver is not only increasing adoption of biomarker testing bottoms up at the physician level, but top down at the large group practice level, especially in the community setting where most patients reside. Accordingly, we recently announced a collaboration with the US Oncology Network and leading community oncology practices to increase the use of biomarker testing to identify patients who would benefit from therapies that target specific cancer pathways.

另一個關鍵的成長驅動力不僅是在醫生層面自下而上地越來越多地採用生物標誌物測試，而且在大型團體實踐層面上自上而下地採用生物標誌物測試，尤其是在大多數患者居住的社區環境。因此，我們最近宣布與美國腫瘤學網絡和領先的社區腫瘤學實踐合作，增加生物標記測試的使用，以確定哪些患者將從針對特定癌症途徑的治療中受益。

Notably, the US Oncology Network has more than 2,500 providers across over 600 sites, treating 1.4 million patients annually. We continue to see strong momentum as we expand our testing offering globally. Last quarter, the Royal Marsden’s Guardant powered laboratory was awarded an expression of interest by the NHS to test advanced non-small cell lung cancer patients, potentially making our technology accessible to patients across England.

值得注意的是，美國腫瘤網絡在 600 多個站點擁有 2,500 多家醫療服務提供者，每年治療 140 萬名患者。隨著我們在全球擴展測試服務，我們繼續看到強勁的勢頭。上個季度，皇家馬斯登 Guardant 動力實驗室獲得了 NHS 的意向書，表示有興趣測試晚期非小細胞肺癌患者，這有可能使全英格蘭的患者都能使用我們的技術。

We also launched Guardant360 in China for biopharma use and have already generated a strong pipeline of over 30 partnerships. Lifetime global biopharma partnerships exceed 165, providing a solid foundation for future growth.

我們也在中國推出了用於生物製藥的 Guardant360，並已建立了由 30 多個合作夥伴組成的強大管道。全球生物製藥終身合作夥伴超過 165 個，為未來成長奠定了堅實的基礎。

Now shifting gears to reveal on slide nine. As mentioned earlier, we hit a major milestone by upgrading reveal to our smart liquid biopsy platform as of year end. With this broad Methylome technology, we can achieve high performance by tracking hundreds to thousands of active alterations per patient compared to 60 to 50 mutations from tumor informed assays.

現在換檔，在第九張投影片上揭曉。如前所述，截至年底，我們透過將 Reveal 升級到我們的智慧液體活檢平台，實現了一個重要的里程碑。借助這種廣泛的甲基化組技術，我們可以透過追蹤每位患者數百至數千個活躍變化來實現高性能，而腫瘤知情檢測則需要追蹤 60 至 50 個突變。

Our low background methylation chemistry leads to ultra high specificity and we maximize overall accuracy by applying machine learning to thousands of clinical samples. Importantly, physicians will be able to use the test to track and quantify tumor fraction in the MRD setting with high precision using our epigenomics based technology. Reveal is currently available for CRC breast and lung cancers and will be expanded to other tumor types over time.

我們的低背景甲基化化學可實現超高特異性，我們透過將機器學習應用於數千個臨床樣本來最大限度地提高整體準確性。重要的是，醫生將能夠使用我們基於表觀基因組學的技術，在 MRD 環境中高精度地追蹤和量化腫瘤分數。Reveal 目前可用於 CRC 乳癌和肺癌，並將隨著時間的推移擴展到其他腫瘤類型。

Moving on to slide 10. We have already generated some promising MRD data on our smart liquid biopsy platform for CRC and breast cancers. Starting with the previously shared data from our COSMOS-Colon study, looking at stage two and three patients, reveal achieved 80% surveillance sensitivity with 99% specificity.

繼續看投影片 10。我們已經在 CRC 和乳癌的智慧液體活檢平台上產生了一些有前景的 MRD 數據。從我們先前分享的 COSMOS-Colon 研究數據開始，觀察第二階段和第三階段的患者，結果顯示監測靈敏度達到 80%，特異性達到 99%。

This data was presented the ASCO GI Symposium in January and will be included in our submission to Medicare for our surveillance indication. Moving on to breast where we have now assessed three clinical cohorts with a reveal assay on smart liquid biopsy. We achieved a blended 82% surveillance sensitivity for distant recurrence with 97% specificity on this combined sizable cohort. This data is very exciting as the performance is in line and if not favorable to other approaches in this space. We look forward to sharing more details about this data this year. This data will be included in our submission to Medicare for our breast indication.

這些數據已於 1 月在 ASCO GI 研討會上提交，並將包含在我們向 Medicare 提交的監測適應證中。轉到乳房，我們現在已經通過智能液體活檢的揭示分析評估了三個臨床隊列。在這個規模相當大的族群中，我們對遠端復發的監測敏感度達到了 82%，特異性達到了 97%。該數據非常令人興奮，因為其性能與該領域的其他方法一致，即使不有利。我們期待今年分享有關此數據的更多詳細資訊。這些數據將包含在我們向 Medicare 提交的有關乳房適應症的資料中。

Moving on to slide 11. As we have shared, we have a strong data pipeline with many clinical cohorts for establishing validity and utility for reveal. We have almost 80,000 samples from 20,000 patients across a variety of solid tumors from our biobank and trials we are running. This rich study pipeline will be instrumental in building compelling evidence that not only supports efforts to expand reimbursement but also has the potential to influence changes in practice guidelines.

繼續看投影片 11。正如我們所分享的，我們擁有強大的數據管道，包含許多臨床隊列，用於確定揭示的有效性和實用性。我們從我們的生物庫和正在進行的試驗中收集了來自 20,000 名患者的近 80,000 個樣本，涉及各種實體腫瘤。這個豐富的研究管道將有助於建立令人信服的證據，不僅支持擴大報銷的努力，而且有可能影響實踐指南的變化。

This year we anticipate publications that will support submission to Medicare for potential additional coverage. Next year we have important clinical validity studies for additional cancers such as lung, pancreatic, and gastric that will support advancement of additional reimbursement.

今年，我們預計將有出版物支持向醫療保險提交潛在的額外承保範圍。明年，我們將對肺癌、胰臟癌和胃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。

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

現在，我將把電話轉給 Amirali，以提供我們篩選業務的最新情況。

Thanks, Helmy. Turning to slide 12. 2024 will be a very exciting year for our screening business as we prepare to launch our Shield IVD test for CRC pending FDA approval. After years of research and development, it is so exciting to prepare to make this test broadly available. There are a number of key milestones for Shield on the near-term horizon.

謝謝，赫爾米。轉向幻燈片 12。2024 年對於我們的篩檢業務來說將是非常令人興奮的一年，因為我們準備推出 CRC 的 Shield IVD 測試，等待 FDA 批准。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。近期內，Shield 有許多重要的里程碑。

First, the data from our pivotal ECLIPSE study has been accepted in a top-tier publication validating the strength and quality of the clinical data. We expect to see it published in the coming months. Additionally, we are continuing to make steady progress with FDA review. Our interactive review process with FDA continues to be collaborative and positive. The advisory committee panel meeting will be the next milestone of the review process.

首先，我們關鍵的 ECLIPSE 研究的數據已被頂級出版物接受，驗證了臨床數據的強度和品質。我們預計它將在未來幾個月內發布。此外，我們將繼續在 FDA 審查方面取得穩步進展。我們與 FDA 的互動審查流程繼續保持合作和積極的態度。諮詢委員會小組會議將是審查過程的下一個里程碑。

In our recent discussions, FDA has informed us that the meeting date will now likely take place in late Q2 as they continue to work to fill the remaining vacant advisory seats on the panel. The date and details of the meeting are subject to confirmation by the FDA and publication in the Federal Register. That said, we continue to expect to receive FDA approval in 2024. Our team is working hard to prepare for this panel meeting and in parallel is preparing to scale up the commercial operations post-FDA approval.

在我們最近的討論中，FDA 通知我們，會議日期現在可能會在第二季末舉行，因為他們將繼續努力填補小組中剩餘的空缺顧問席位。會議的日期和細節須經 FDA 確認並在《聯邦公報》上公佈。也就是說，我們仍然期望在 2024 年獲得 FDA 的批准。我們的團隊正在努力準備本次小組會議，同時準備擴大 FDA 批准後的商業運作。

Turning to slide 13, while Shield has only been in market for a short time, we are highly encouraged by the overwhelming enthusiasm expressed by PCPs and health systems. We are witnessing real-world evidence of its effectiveness and the potential to drive unparalleled compliance in completing cancer screening. In the first 20,000 order Shield test the adherence rate was 94%, which is much higher than the range of 38% to 65% with current modalities.

轉向幻燈片 13，雖然 Shield 進入市場的時間很短，但 PCP 和衛生系統所表現出的壓倒性熱情令我們深受鼓舞。我們正在見證其有效性的現實證據，以及在完成癌症篩檢方面推動無與倫比的合規性的潛力。在第一個 20,000 份 Shield 測試中，遵守率為 94%，遠高於目前模式 38% 至 65% 的範圍。

As we shared at JP Morgan, in a health system setting, a randomized 2,000 patient study was conducted at Kaiser Permanente to evaluate the impact of introducing Shield as a new option to improve the overall screening rate. The study readout was positive and the results were published in two papers in PLOS ONE and Gut.

正如我們在摩根大通分享的那樣，在衛生系統環境中，Kaiser Permanente 進行了一項針對 2,000 名患者的隨機研究，以評估引入 Shield 作為提高整體篩檢率的新選項的影響。研究結果是正面的，結果發表在 PLOS ONE 和 Gut 上的兩篇論文中。

The study demonstrated that when individuals who hadn't completed FIT were offered Shield, the rate of screening increased by more than three times. Notably, over 40% of those patients who took the Shield test for CRC screening had not been screened before. Additionally, 100% of surveyed patients and physicians were optimistic about the idea of a blood-based CRC screening test offering being incorporated into a routine healthcare visit. These publications highlight the significant impact of what Shield can do when this blood test is added as a new and accessible option for CRC screening.

研究表明，當向未完成 FIT 的個人提供 Shield 時，篩檢率增加了三倍以上。值得注意的是，在接受 Shield 測試進行 CRC 篩檢的患者中，超過 40% 的患者之前從未接受過篩檢。此外，100% 的受訪患者和醫生對將基於血液的 CRC 篩檢測試納入常規醫療保健就診的想法持樂觀態度。這些出版物強調了當這种血液檢測被添加為 CRC 篩檢的新且易於使用的選項時，Shield 可以發揮的重大影響。

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

現在，我將把電話轉給麥克，以了解有關我們財務狀況的更多詳細資訊。

Thanks, Amirali. Starting with our financial results on slide 14, total revenue for the fourth quarter of 2023 grew 22% to $155.1 million compared to $126.9 million in the prior quarter. Total precision oncology testing revenue for the fourth quarter was $142.2 million, increasing 25% compared to $113.8 million in the prior quarter. This increase was predominantly driven by strong year-over-year growth in both clinical and biopharma volumes.

謝謝，阿米拉利。從投影片 14 的財務表現開始，2023 年第四季的總營收成長了 22%，達到 1.551 億美元，而上一季的總營收為 1.269 億美元。第四季精準腫瘤檢測總收入為 1.422 億美元，較上一季的 1.138 億美元成長 25%。這一增長主要是由臨床和生物製藥銷售的強勁同比增長推動的。

Precision oncology revenue from clinical tests in the fourth quarter totaled $108.2 million, up 29% from $83.7 million for the prior quarter. Fourth quarter clinical test volume was $46,400, an increase of 29% from the same period of the prior year. Guardant360 continues to be the main revenue driver, with strong year-over-year volume growth across all cancers in the US, as well as volume contribution from Japan and the UK in the fourth quarter.

第四季臨床測試帶來的精準腫瘤學收入總計 1.082 億美元，比上一季的 8,370 萬美元成長 29%。第四季臨床試驗量為46,400美元，較去年同期成長29%。Guardant360 仍然是主要的收入驅動力，美國所有癌症的銷售量同比強勁增長，第四季度日本和英國的銷售貢獻也很大。

We also saw a sequential rise in the Guardant360 ASP in the fourth quarter, which increased to approximately $2,750 from approximately $2,700 in Q3. This was driven by the continued pull-through from the expanded commercial coverage received earlier in the year, and from the interim Medicare gap full rate for Guardant360 LDT, which increased from $3,500 to $3,967 on October 1.

我們還看到第四季度 Guardant360 的平均售價連續上升，從第三季的約 2,700 美元增加到約 2,750 美元。這是由於今年稍早擴大的商業承保範圍的持續拉動，以及 Guardant360 LDT 的臨時醫療保險缺口全額費率（10 月 1 日從 3,500 美元增至 3,967 美元）推動的。

As a reminder, the Guardant360 LDT Medicare rate increased again on January 1, 2024, to the new rate of $5,000, which we expect will increase the Guardant360 ASP to be in the range $2,850 to $2,900 in the first quarter of 2024.

提醒一下，Guardant360 LDT Medicare 費率於 2024 年 1 月 1 日再次上調，達到新的 5,000 美元，我們預計這將使 Guardant360 的平均售價在 2024 年第一季度提高到 2,850 美元至 2,900 美元之間。

Blended clinical ASP was approximately $2,330 for the fourth quarter, which was similar to the blended clinical ASP of $2,320 in Q4 2022, with the increase in Guardant360 ASP offsetting the mixed impact of different products and geographies. Precision oncology revenue from biopharmacists in Q4 totaled $34.0 million, up 13% from $30.1 million for the prior year quarter.

第四季的混合臨床 ASP 約為 2,330 美元，與 2022 年第四季的混合臨床 ASP 2,320 美元相似，Guardant360 ASP 的成長抵消了不同產品和地區的混合影響。第四季來自生物藥劑師的精準腫瘤學收入總計 3,400 萬美元，比去年同期的 3,010 萬美元成長 13%。

Biopharma test volume was strong in the fourth quarter, totaling approximately 9,500 tests, up 16% from the prior year quarter. Biopharma ASP was approximately $3,600 in the fourth quarter of 2024. Development services and other revenue in the fourth quarter totaled $12.9 million, compared to $13.1 million in the prior year quarter.

第四季生物製藥測試量強勁，總計約 9,500 項測試，比去年同期成長 16%。2024 年第四季生物製藥平均售價約為 3,600 美元。第四季開發服務和其他收入總計 1,290 萬美元，而去年同期為 1,310 萬美元。

Total gross margin was 60%, compared to 63% in the prior year quarter. For precision oncology, gross margin was 60% in the fourth quarter of 2023, compared to 62% in the fourth quarter of 2022. While we saw improvements in the gross margin for clinical Guardant360 tests due to the increase in ASP, the overall precision oncology gross margin declined slightly due to changes in the mix of clinical and biopharma tests, the mix of Guardant360 TissueNext and Reveal tests, and the mix of US and international tests.

總毛利率為 60%，去年同期為 63%。對於精準腫瘤學，2023年第四季的毛利率為60%，而2022年第四季的毛利率為62%。雖然我們看到由於 ASP 的增加，臨床 Guardant360 測試的毛利率有所改善，但由於臨床和生物製藥測試組合、Guardant360 TissueNext 和 Reveal 測試的組合以及美國和國際測試的結合。

Development services and other gross margin was 60% in the fourth quarter of 2023, compared to 74% in Q4 2022. The change in margin was primarily due to the cost of processing Shield LDT samples, which increased in volume year-over-year, and for which we are currently booking minimal revenue. Social research and development, sales and marketing, and G&A operating expenses for the fourth quarter of 2023 were $206.6 million, a reduction of $19.2 million, compared to Q4 2022.

2023 年第四季開發服務和其他毛利率為 60%，而 2022 年第四季為 74%。利潤率的變化主要是由於處理 Shield LDT 樣品的成本所致，該樣品的數量逐年增加，而我們目前為此預訂了最低收入。2023 年第四季的社會研發、銷售和行銷以及一般管理費用營運費用為 2.066 億美元，比 2022 年第四季減少 1,920 萬美元。

In Q4 2023, we also recorded a liability and a resulting non-recurring charge to other operating expense of $83.4 million, related to the recent jury verdict in a patent infringement lawsuit. Notwithstanding this one-time charge, we plan to file motions to overturn the verdict, seek a new trial, and or amend the judgment.

2023 年第四季度，我們還記錄了 8,340 萬美元的負債和由此產生的非經常性費用，這與陪審團最近在專利侵權訴訟中的裁決有關。儘管有這項一次性指控，我們仍計劃提出動議推翻判決、尋求新的審判和/或修改判決。

Net loss was $187.0 million, or $1.58 per share for the fourth quarter of 2023, compared to $139.9 million, or $1.36 per share in the fourth quarter of 2022. Turning to the full year, total revenue was $563.9 million, up 25% from $449.5 million in the prior year. Precision oncology revenue increased 31% to $514.2 million.

2023 年第四季的淨虧損為 1.870 億美元，即每股 1.58 美元，而 2022 年第四季的淨虧損為 1.399 億美元，即每股 1.36 美元。全年總收入為 5.639 億美元，比上年的 4.495 億美元成長 25%。精準腫瘤學收入成長 31%，達到 5.142 億美元。

Clinical testing revenue was $403.9 million, which grew 35% year-over-year, driven by a 39% increase in clinical testing volume. The strong volume growth was driven by Guardant360, with growth across all cancer types. TissueNext, which grew more than 80%, and Reveal, which grew over 90%. Biopharma testing revenue was $110.4 million, which increased 17% year-over-year. Biopharma volume increased 15% year-over-year, primarily driven by the uptake of Guardant Infinity, which also led to an improved biopharma ASP in 2023 of approximately $3,700, compared to $3,610 in 2022.

臨床測試收入為 4.039 億美元，年增 35%，主要得益於臨床測試量成長 39%。Guardant360 推動了銷售的強勁成長，所有癌症類型均實現成長。TissueNext 成長超過 80%，Reveal 成長超過 90%。生物製藥測試收入為 1.104 億美元，年增 17%。生物製藥銷量年增 15%，主要是由於 Guardant Infinity 的採用，這也導致 2023 年生物製藥平均售價提高至約 3,700 美元，而 2022 年為 3,610 美元。

Development services and other revenue declined 14% to $49.7 million in 2023. This reduction was in line with our guidance at the start of 2023, and primarily due to the variable timing, progress, and milestones related to projects with third parties, as well as the year-over-year reduction in royalty revenue. Total gross margin was 60%, compared to 65% in 2022. For precision oncology, gross margin was 60% in 2023, compared to 62% in 2022.

2023 年，開發服務和其他收入下降 14%，至 4,970 萬美元。這項減少符合我們在 2023 年初的指導，主要是由於與第三方專案相關的時間、進度和里程碑的可變，以及特許權使用費收入的同比減少。總毛利率為 60%，而 2022 年為 65%。對於精準腫瘤學，2023 年毛利率為 60%，而 2022 年為 62%。

The slight year-over-year decline is consistent with the change we saw in the fourth quarter, where increases in ASP have been more than offset by changes in product mix. Development services and other gross margin was 57% in 2023, compared to 86% in 2022. The change in margin was primarily due to the cost of processing Shield LDT samples, which was booked as a sales and marketing expense until the end of Q3 2022, and which was booked to development services and other costs from Q4 2022 onwards. In both 2022 and 2023, Shield LDT revenue was not material.

年比小幅下降與我們在第四季度看到的變化一致，第四季度平均售價的成長被產品組合的變化所抵消。2023 年開發服務和其他毛利率為 57%，而 2022 年為 86%。利潤率的變化主要是由於處理 Shield LDT 樣品的成本，該成本在 2022 年第三季末之前記入銷售和行銷費用，並從 2022 年第四季起記入開發服務和其他成本。在 2022 年和 2023 年，Shield LDT 的收入並不重要。

Total research and development, sales and marketing, and G&A operating expenses for the full year 2023 were $818.2 million, a decrease of $19.4 million, compared to 2022. Net loss was $479.4 million in 2023, compared to $654.6 million in 2022. Net loss per share was $4.28 in 2023, as compared to $6.41 in 2022.

2023 年全年研發、銷售和行銷以及 G&A 營運費用總額為 8.182 億美元，比 2022 年減少 1,940 萬美元。2023 年淨虧損為 4.794 億美元，而 2022 年淨虧損為 6.546 億美元。2023 年每股淨虧損為 4.28 美元，而 2022 年每股淨虧損為 6.41 美元。

Moving on to non-GAAP financial measures on slide 15. From this quarter onwards, we will report non-GAAP gross margin measures to provide better clarity on the performance of the business. Most importantly, we will provide a non-GAAP gross margin measure, which excludes the costs related to performing screening tests in our lab, which currently generate minimal revenue.

接下來討論投影片 15 上的非 GAAP 財務指標。從本季開始，我們將報告非 GAAP 毛利率指標，以便更清晰地了解業務績效。最重要的是，我們將提供非公認會計原則毛利率衡量標準，其中不包括與在我們實驗室進行篩選測試相關的成本，而目前這些測試產生的收入很少。

As a reminder, from Q4 2022, we have recorded the cost of providing Shield LDT screening tests in the development services and our income statement. During both the fourth quarter and full year 2023, the non-GAAP gross margin was 61%, and the non-GAAP gross margin excluding screening was 63%. Again, we will continue to report this important metric going forward.

提醒一下，從 2022 年第四季開始，我們已在開發服務和損益表中記錄了提供 Shield LDT 篩選測試的成本。2023 年第四季和全年，非 GAAP 毛利率均為 61%，不包括放映的非 GAAP 毛利率為 63%。再次，我們將繼續報告這項重要指標。

Non-GAAP operating expenses, which exclude the non-recurring charge mentioned earlier, were $183.1 million for the fourth quarter 2023, a reduction of $18.1 million compared to the prior year quarter. For the full year, we achieved our previously stated guidance that we would reduce non-GAAP operating expenses in 2023 compared to 2022.

2023 年第四季的非 GAAP 營運費用（不包括前面提到的非經常性費用）為 1.831 億美元，比去年同期減少 1,810 萬美元。就全年而言，我們實現了先前提出的指導方針，即與 2022 年相比，我們將在 2023 年減少非 GAAP 營運費用。

Accordingly, full year 2023 non-GAAP operating expenses were $729.2 million, compared to $736.6 million in 2022. Non-GAAP net loss was $75.9 million, or $0.64 per share, for the fourth quarter of 2023, compared to $119.6 million, or $1.17 per share, for the fourth quarter of 2022. For the full year 2023, non-GAAP net loss was $352.3 million, or $3.15 per share, compared to $435.4 million, or $4.26 per share for 2022.

因此，2023 年全年非 GAAP 營運費用為 7.292 億美元，而 2022 年為 7.366 億美元。2023 年第四季的非 GAAP 淨虧損為 7,590 萬美元，即每股 0.64 美元，而 2022 年第四季的淨虧損為 1.196 億美元，即每股 1.17 美元。2023 年全年，非 GAAP 淨虧損為 3.523 億美元，即每股 3.15 美元，而 2022 年為 4.354 億美元，即每股 4.26 美元。

Adjusted EBITDA was a loss of $78.4 million in the fourth quarter of 2023, compared to a $109.8 million loss in the fourth quarter of 2022. For the full year 2023, adjusted EBITDA was a loss of $344.2 million in 2023, which represents a $59.2 million reduction compared to a loss of $403.4 million in 2022. Free cash flow for the fourth quarter of 2023 was negative $82.8 million, compared to a negative $100.8 million in Q4 2022. For the full year 2023, we achieved our previously stated guidance that we would reduce our cash burn from a high of negative $387 million in 2022 to below negative $350 million in 2023. Accordingly, free cash flow was negative $345 million for the full year of 2023.

2023 年第四季調整後 EBITDA 虧損 7,840 萬美元，而 2022 年第四季虧損 1.098 億美元。就 2023 年全年而言，2023 年調整後 EBITDA 虧損 3.442 億美元，與 2022 年虧損 4.034 億美元相比減少了 5,920 萬美元。2023 年第四季的自由現金流為負 8,280 萬美元，而 2022 年第四季為負 1.008 億美元。對於 2023 年全年，我們實現了先前提出的指導方針，即我們將把現金消耗從 2022 年負 3.87 億美元的高點減少到 2023 年負 3.5 億美元以下。因此，2023 年全年自由現金流為負 3.45 億美元。

Looking more closely at our cash position on slide 16, we ended the fourth quarter of 2023 with cash, cash equivalents, and short-term marketable debt securities of approximately $1.2 billion, and successfully lowered our cash burn to our target of less than $350 million, while continuing to grow our therapy selection business and make significant investments in both MRD and screening.

更仔細檢視投影片16 中我們的現金狀況，我們在2023 年第四季結束時擁有約12 億美元的現金、現金等價物和短期有價債務證券，並成功將現金消耗降低至低於3.5 億美元的目標，同時繼續發展我們的治療選擇業務，並在 MRD 和篩檢方面進行大量投資。

As Helmy mentioned, we achieved our target of reaching cash flow break-even in therapy selection as of the end of 2023. As we look ahead to the next five years, we are confident that by starting to generate positive cash flow from therapy selection, driving MRD to profitability, and carefully managing the spending of our screening business to approximately $200 million annually for the next five years, we can continue to lower our cash burn each year so that by the time we reach 2028, we'll be cash flow break-even, which is achievable with our current cash balance of $1.2 billion.

正如 Helmy 所提到的，我們實現了到 2023 年底在治療選擇方面實現現金流收支平衡的目標。展望未來五年，我們有信心透過治療選擇開始產生正現金流，推動 MRD 實現盈利，並在未來五年仔細管理我們的篩檢業務支出，使其每年達到約 2 億美元，我們可以繼續降低每年的現金消耗，以便到2028 年時我們將實現現金流收支平衡，這在我們目前12 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 2023 on slide 17. We expect full year 2024 revenue to be in the range of $655 million to $670 million, representing growth of approximately 16% to 19% compared to 2023. This guidance does not include any revenue contributions from screening, which are dependent on the timing of Shield FDA approval and Medicare reimbursement coverage. We will update our revenue guidance to include screening revenue when appropriate.

現在轉向幻燈片 17 上我們對 2023 年全年的展望和假設。我們預計 2024 年全年營收將在 6.55 億美元至 6.7 億美元之間，較 2023 年成長約 16% 至 19%。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。我們將更新我們的收入指導，以在適當的時候包括放映收入。

For 2024, we are also providing guidance on our non-GAAP gross margin excluding screening, which we expect to be in the range of 60% to 62%. We expect non-GAAP operating expenses to be in the range of $740 million to $750 million, representing 1% to 3% increase year-over-year. This guidance includes screening operating expenses, which will be primarily focused on the launch and commercialization of Shield following expected FDA approval, as well as continued screening research and development efforts.

對於 2024 年，我們也提供了不包括篩檢在內的非 GAAP 毛利率指引，我們預計該毛利率將在 60% 至 62% 之間。我們預計非 GAAP 營運費用將在 7.4 億至 7.5 億美元之間，年增 1% 至 3%。該指南包括篩選營運費用，該費用將主要集中於預期 FDA 批准後 Shield 的推出和商業化，以及持續的篩選研究和開發工作。

Finally, we expect free cash flow to be in the range of negative $320 million to $330 million in 2023. This guidance assumes a maximum $200 million net cash outflow for screening, which could adjust downwards during the year, depending on the timing and outcome of the FDA approval process. To provide some additional color on our cash burn for 2024, we expect cash used in operating activities to reduce by approximately $40 million compared to 2023. This reduction will be partially offset by a planned increase of approximately $20 million for the purchase of capital equipment as we ramp up lab capacity in preparation for the launch of Shield.

最後，我們預計 2023 年自由現金流將在負 3.2 億美元至 3.3 億美元之間。該指南假設用於篩選的淨現金流出最高為 2 億美元，該數字可能會在年內向下調整，具體取決於 FDA 審批流程的時間和結果。為了讓我們對 2024 年的現金消耗有更多的了解，我們預計經營活動中使用的現金將比 2023 年減少約 4,000 萬美元。隨著我們提高實驗室能力以準備推出 Shield，計劃增加約 2000 萬美元用於購買固定設備，這一減少將部分抵消。

Finally, turning to slide 18 to review our catalyst. As we look ahead to 2024 and beyond, we have a number of upcoming catalysts in each of our business areas, including smart liquid biopsy upgrades for Guardant360 and volume expansion across therapy selection, data publication for MRD, and Shield FDA approval and launch.

最後，轉向幻燈片 18 回顧我們的催化劑。展望 2024 年及以後，我們的每個業務領域都有許多即將到來的催化劑，包括 Guardant360 的智慧液體活檢升級和治療選擇的數量擴展、MRD 的數據發布以及 Shield FDA 的批准和推出。

With that, we will now open the call to questions.

現在，我們將開始提問。

(Operator Instructions) Mark Massaro, BTIG.

（操作員說明）Mark Massaro，BTIG。

Hey, guys. Thank you for taking the questions. My first one is for Amirali. Can you maybe provide a little more context about the pushout of the [ADCOM] meeting? Is it largely just logistical in nature? You said late Q2, so should we kind of pencil in June? I'm curious if it's just a matter of filling who will attend the meeting.

嘿，夥計們。感謝您提出問題。我的第一個是給阿米拉利的。您能否提供有關 [ADCOM] 會議取消的更多背景資訊？這在很大程度上只是後勤方面的嗎？你說第二季很晚，那我們應該在六月用鉛筆嗎？我很好奇這是否只是填補誰會參加會議的問題。

And then my second question is really around -- there's been a lot of discussion about advanced adenomas. Can you guys confirm if you're planning to request an AA label from the FDA?

然後我的第二個問題確實存在──關於晚期腺瘤有很多討論。你們能確認一下你們是否打算向 FDA 申請 AA 標籤嗎？

Thanks, Mark. Great question. In terms of ADCOM, as I mentioned in the previous remark, FDA notified us that because of scheduling and mainly the fact that the panel was half empty at the time that they called for the panel, they need to go and identify some additional members to be added to the specific panel that our device is going to, go through the vetting process, and so forth.

謝謝，馬克。很好的問題。就 ADCOM 而言，正如我在之前的評論中提到的，FDA 通知我們，由於日程安排以及主要是在他們召集專家組時專家組半空的事實，他們需要去確定一些額外的成員來添加到我們的設備將要添加到的特定面板中，經過審核過程等等。

As a result, they are kind of scheduling it now for late Q2. Once we know the confirmed date, it's going to get communicated somehow. It's going to in the federal register at the appropriate time, too. So that's all we know at this time. There's no other kind of reasons behind this delay. But I will reiterate that this kind of ADCOM timeline is not impacting the timeline for the FDA review and the expectation that we had from the beginning that we believe we get FDA decision about Shield approval sometime in 2024.

因此，他們現在將其安排在第二季末。一旦我們知道確認日期，就會以某種方式溝通。它也將在適當的時候進入聯邦登記冊。這就是我們目前所知道的一切。這種延遲背後沒有其他原因。但我要重申的是，這種 ADCOM 時間表不會影響 FDA 審查的時間表，也不會影響我們從一開始就相信 FDA 會在 2024 年某個時候批准 Shield 的決定。

Regarding AA, I think that continues to be an interesting hot topic in the field in terms of our label. We didn't get to the label discussion with agency. It happens typically in very late innings of the review process. But this discussion of CRC sensitivity, AA sensitivity, the performance that we've seen in ECLIPSE, and the risk benefit of this device in the intended use patient population, potentially is going to get discussed in the ADCOM to get some feedback from external opinion for agency.

關於 AA，我認為就我們的廠牌而言，這仍然是該領域一個有趣的熱門話題。我們沒有與代理商進行標籤討論。它通常發生在審核過程的最後階段。但是，關於 CRC 敏感性、AA 敏感性、我們在 ECLIPSE 中看到的性能以及該設備在預期使用患者群體中的風險益處的討論可能會在 ADCOM 中進行討論，以從外部意見中獲得一些反饋用於代理。

(Operator Instructions) Puneet Souda, Leerink Partners.

（操作員說明）Puneet Souda，Leerink Partners。

Thanks for taking the question. So, I'll wrap two of my questions into one. First one on just the core business G360. When I look at the guide, you have 5,000 reimbursement now for G360 LDT. Volume seems to be good. Can you maybe just elaborate sort of what is driving the level of maybe, for lack of a better word, conservatism this year? Anything that we need to note on the MRD side that is accounting for that?

感謝您提出問題。因此，我將把我的兩個問題合併為一個。第一個僅涉及核心業務 G360。我看指南，現在G360 LDT有5000報銷。音量好像不錯。您能否詳細說明一下，是什麼推動了今年保守主義的水平？在 MRD 方面我們需要注意什麼來解釋這一點？

And then, on the Shield, maybe just, Amirali, could you remind us if FDA will require a publication of the paper before the advisory committee? Thank you.

然後，關於盾牌，也許只是，Amirali，您能否提醒我們 FDA 是否會要求在諮詢委員會面前發表該論文？謝謝。

Thanks, Puneet. Maybe I'll pass the mic to give some color on the guide.

謝謝，普尼特。也許我會透過麥克風為指南提供一些顏色。

Yeah, Puneet, on the guide, you mentioned Guardant360. I mean, I think we're looking at 2024 still being a year of strong growth for Guardant360. We've got we had good traction in the US in 2023. And so, I think we expect that to continue. And that's across all kinds of sites. And with a lot of the work that we're doing that are customer-focused activities, I think we can still expect that growth to continue.

是的，Puneet，在指南中，您提到了 Guardant360。我的意思是，我認為 2024 年仍然是 Guardant360 強勁成長的一年。2023 年，我們在美國擁有良好的吸引力。因此，我認為我們預計這種情況會繼續下去。這適用於所有類型的網站。由於我們正在做的許多工作都是以客戶為中心的活動，我認為我們仍然可以預期這種成長會持續下去。

And also we're now seeing good traction outside the US and especially in Japan and the UK. So, that should also lead to good volume growth. You're right. We'll get an ASP uplift from Guardant360 as well with the LDT now moving from $3,500 to$ 5,000.

而且我們現在在美國以外的地區也看到了良好的吸引力，尤其是在日本和英國。因此，這也應該會帶來良好的銷售成長。你說得對。Guardant360 的 ASP 也會有所提升，LDT 現在從 3,500 美元升至 5,000 美元。

So, again, that's really positive. From an MRD perspective, we saw something like 90% or over growth last year. We're still expecting growth we've revealed in 2024. We want to manage that growth, though. We still want to get additional reimbursement. It's currently a gross margin negative test for us. So, it costs us every time we run a test. And so, we just want to manage that volume until we get incremental reimbursement. And then we can take the foot off the brakes and really drive that. So, yeah, hopefully that answers the questions on the guide.

所以，再說一遍，這確實是正面的。從 MRD 的角度來看，去年我們看到了 90% 或以上的成長。我們仍然期待 2024 年公佈的成長。不過，我們希望控制這種成長。我們仍然希望獲得額外的補償。目前這對我們來說是毛利率的負面考驗。因此，每次運行測試都會花費我們的成本。因此，我們只想管理這個數量，直到我們獲得增量報銷。然後我們就可以把腳從煞車上移開並真正駕駛它。所以，是的，希望這能回答指南中的問題。

And quickly about Shield and FDA and paper -- the FDA review process is not dependent on paper publication. They do their own extensive -- look at the data at very detail that we have gone through that process. I'm pleased with the progress so far. So, they go through their own evaluation. They don't look at have you got it published in a peer-reviewed publication or not.

快速了解 Shield 和 FDA 以及論文—FDA 審查過程並不依賴論文發表。他們自己進行了廣泛的研究——非常詳細地查看我們已經經歷過的過程的數據。我對迄今為止的進展感到滿意。因此，他們會進行自己的評估。他們不會看你是否在同行評審的出版物上發表了它。

(Operator Instructions) Dan Leonard, UBS.

（操作員說明）Dan Leonard，UBS​​。

Thank you. I actually had a follow-up on that last point. Amirali, can you elaborate further on the timing of the ECLIPSE publication? I think there was an expectation at one point that would occur in 2023. Is that imminent or just any color you could share? Thank you.

謝謝。我實際上對最後一點進行了跟進。Amirali，您能進一步詳細說明 ECLIPSE 發布的時間嗎？我認為曾經有一個預期會在 2023 年發生。這是迫在眉睫的還是您可以分享的任何顏色？謝謝。

Yes. Actually, that was our goal. I think the tier of the journal that we picked was-- I think top tier, which kind of impacted some of the review process. But we are very pleased that we went to that journal. We are right now on their embargo with that journal. So, unfortunately, I cannot tell a lot of details. So, and the journal is scheduling the publication based on the issue planning that they have. So, but it should be within the next few months, as I mentioned, the pre-prep remark.

是的。事實上，這就是我們的目標。我認為我們選擇的期刊級別是——我認為是頂級，這會影響一些評審過程。但我們很高興我們讀了那本雜誌。我們現在正在對該期刊實施禁運。因此，不幸的是，我無法透露很多細節。因此，該期刊正在根據他們現有的發行計劃安排出版時間。所以，但正如我所提到的，預準備評論應該在接下來的幾個月內進行。

(Operator Instructions) Tejas Savant, Morgan Stanley.

（操作員指令）Tejas Savant，摩根士丹利。

Hey, guys. Good evening and thanks for the time here. Maybe one for you, Mike, and then I have a follow-up on MRD. In the guide, Mike, what are you factoring in in terms of [OUS] contributions this year? Is it all just Japan and the UK largely, or could we start to see some traction from China and Biopharma in addition to that Hikma partnership that you recently announced?

嘿，夥計們。晚上好，感謝您抽出寶貴的時間。麥克，也許給你一個，然後我有關於 MRD 的後續報導。麥克，在指南中，您將今年 [OUS] 的貢獻考慮在內？主要是日本和英國，還是除了您最近宣布的 Hikma 合作夥伴關係之外，我們是否可以開始看到來自中國和生物製藥的一些吸引力？

And then on the MRD side of things, one for you, Helmy, where are you in terms of the COSMOS data that you talked about in your prepared remarks at ASCO GI in terms of publication? And what are you assuming in the guide for CMS reimbursement and then revenue from the CRC surveillance indication, which obviously is a much bigger opportunity than just the adjuvant setting? Thank you.

然後，在 MRD 方面，Helmy，您在 ASCO GI 準備好的演講中談到的 COSMOS 資料處於什麼位置？您在 CMS 報銷指南中假設什麼，然後從 CRC 監測適應症中獲得收入，這顯然是一個比單純輔助治療更大的機會？謝謝。

Yeah, I can take on the international side, Tejas. Yeah, we're not breaking out, the volumes and the revenue by different geographies, but we'll start to see Japan and the UK be the real drivers on the clinical side. Outside of the US, we got Japan reimbursement back in the second half of last year, so that launch is going very well.

是的，我可以參加國際比賽，Tejas。是的，我們並沒有突破不同地區的銷售和收入，但我們將開始看到日本和英國成為臨床的真正驅動力。在美國以外，我們在去年下半年獲得了日本的補償，因此發布進展順利。

And then we started to come online with Royal Marsden really in Q4 of last year. So, again, we're seeing good traction there, and we think that they'll start to contribute to the revenue and the volume in 2024. In the Middle East region with Hikma, I think probably less of an opportunity there, but we still could start to see some contribution there.

然後我們在去年第四季開始與皇家馬斯登上線。因此，我們再次看到了那裡的良好吸引力，我們認為他們將在 2024 年開始為收入和銷售做出貢獻。在中東地區的 Hikma，我認為那裡的機會可能較少，但我們仍然可以開始看到那裡的一些貢獻。

But really, we're looking at Japan and the UK. And then China is in the Biopharma line. And again, I think we're assuming that that starts to contribute. The lab that we have with [Ali] came online just recently. We've got a really good pipeline in China. We're potentially working with a lot of partners in that country. And so, yeah, that's going to contribute to our Biopharma revenue during 2024.

但實際上，我們正​​在關注日本和英國。然後中國屬於生物製藥業。再說一次，我認為我們假設這開始有所貢獻。我們與[阿里]合作的實驗室最近才剛上線。我們在中國擁有非常好的管道。我們可能正在與該國的許多合作夥伴合作。所以，是的，這將在 2024 年為我們的生物製藥收入做出貢獻。

In terms of MRD, yeah, I think we're preparing the publication for COSMOS as we speak. We're very happy with the data, and we're going to push that out as fast as we can. And hopefully, once it gets published, it's something that can make up the bulk of our dossier for the CRC surveillance indication. But I don't think there is -- there's almost nothing, I think, baked into the guide this year in terms of CRC surveillance. So, that's all upside right now.

就 MRD 而言，是的，我認為我們正在為 COSMOS 準備出版物。我們對這些數據非常滿意，我們將盡快推出這些數據。希望它一旦發布，就能成為我們 CRC 監測指標檔案的主要內容。但我認為今年的指南中幾乎沒有關於 CRC 監測的內容。所以，現在這都是有利的。

(Operator Instructions) Dan Arias Stifel.

（操作員說明）Dan Arias Stifel。

Yeah, hi, guys. Thanks for the questions here. Helmy, can you just maybe orient us on smart liquid biopsy within the portfolio? On the upgrade for Reveal, I just want to confirm that all the tests going out the door are through the smart assay. And then when can we expect G360 to be upgraded? I know you said this year. I'm wondering if there's anything more specific in terms of first half's versus second half's? And then just lastly, if I may, are there any changes to the assay within clinical trials that are ongoing that need to be made and that we should be keeping in mind? Thanks.

是的，嗨，夥計們。感謝您在這裡提出的問題。Helmy，可以為我們介紹一下產品組合中的智慧液體切片嗎？關於 Reveal 的升級，我只是想確認所有測試都是透過智慧檢測進行的。那麼G360什麼時候可以升級呢？我知道你說的是今年。我想知道上半場和下半場有什麼更具體的嗎？最後，如果可以的話，我們應該牢記正在進行的臨床試驗中的檢測是否有任何需要進行的改變？謝謝。

Yeah, no, great questions. Thanks, Dan. So, yeah, all the Reveal tests now are on smart liquid biopsy. We've transitioned, I think, nearly all of the trials that were on that were possible to smart liquid biopsies. I think we're in a good spot there. We're seeing really good traction. I think a lot of excitement both on the clinical side as well as the biopharma side in terms of the performance of that assay.

是的，不，很好的問題。謝謝，丹。所以，是的，現在所有的 Reveal 測試都是針對智慧液體活檢。我認為，我們已經將幾乎所有可能的試驗轉變為智慧液體活檢。我認為我們處於一個很好的位置。我們看到了非常好的牽引力。我認為臨床方面和生物製藥方面對該檢測的性能都非常興奮。

I think we are in a good place in terms of the transition around Guardant360. We want to make sure that we transition that properly from a sort of reimbursement point of view and regulatory point of view. So those are going to be the gating items in terms of that transition.

我認為我們在 Guardant360 的過渡方面處於有利位置。我們希望確保從報銷的角度和監管的角度正確過渡。因此，這些將成為這一轉變的門控項目。

But I can tell you right now that there is a lot of excitement, especially at the academic centers around G360 and smart liquid biopsy. We see that as a major, major catalyst for our business when that comes out. And and the same thing on the -- we didn't mention the preparative remarks, but tissue will also be upgraded this year to a larger panel and then some more features. And that's a project that has been doing well for us. I think a lot of these sort of transitions that will happen later this year, I think, sort of further upside in terms of where we could go from a clinical volume point of view.

但我現在可以告訴你，有很多令人興奮的事情，特別是在圍繞 G360 和智慧液體活檢的學術中心。當它問世時，我們認為這是我們業務的一個主要催化劑。同樣的事情 - 我們沒有提到準備性評論，但今年紙巾也將升級為更大的面板，然後是更多功能。這個項目對我們來說一直表現良好。我認為今年稍後將發生許多此類轉變，我認為，從臨床數量的角度來看，我們可以走向何方？

(Operator Instructions) Matt Sykes, Goldman Sachs.

（操作員指令）Matt Sykes，高盛。

Hey, good afternoon. Thanks for taking my question. Maybe one for you, Mike. Just given you hit cash flow break-even in therapy selection last year, maybe could you give us a sense for sort of the operating leverage within that individual segment? Just given the growth you expect to see this year, is there any kind of color you can give around sort of how that cash flow can grow over time so that it can kind of offset some of the spend you're doing?

嘿，下午好。感謝您提出我的問題。也許有一個適合你，麥克。鑑於您去年在治療選擇方面達到了現金流收支平衡，也許您能否讓我們了解該單獨細分市場的營運槓桿？考慮到您今年預計會看到的增長，您是否可以提供任何顏色來說明現金流如何隨著時間的推移而增長，以便它可以抵消您正在做的一些支出？

I assume some of the spend in therapy selection is not as much as you might need for Shield and other areas. I'm just trying to get a sense for how that cash flow and profitability can grow over the course of this year and into 2025.

我認為在治療選擇上的一些支出並不像您在護盾和其他領域可能需要的那麼多。我只是想了解從今年到 2025 年現金流和獲利能力如何成長。

Yeah, Matt, it's a good question. I mean, I think we've laid it out, I think, quite consistently that now that therapy selection, really we're building infrastructure across that business, and we can get huge leverage now from the infrastructure that we've built. From a research and development, sales and marketing, across all the lines they're going to be relatively steady going forward, probably for 2024.

是的，馬特，這是個好問題。我的意思是，我認為我們已經非常一致地制定了治療選擇，我們實際上正在跨該業務建立基礎設施，並且我們現在可以從我們構建的基礎設施中獲得巨大的影響力。從研發、銷售到行銷，所有領域的發展都將相對穩定，可能到 2024 年。

The only area where we'll look to slightly increase the spend on therapy selection is going to be in sales and marketing as we really focus on the customer experience elements and the EMR integrations. That's going to be really the only incremental spend. So more or less every sort of additional dollar of gross profit is dropping down to the bottom line in therapy selection.

我們希望稍微增加治療選擇支出的唯一領域是銷售和行銷，因為我們真正專注於客戶體驗元素和 EMR 整合。這實際上將是唯一的增量支出。因此，或多或少每一種額外的毛利都會下降到治療選擇的底線。

And maybe just to give a little bit of color on the overall cash burn that we've guided to $320 million to $330 million. You can look at that in different chunks. Roughly $200 million is screening. We've been very clear about that. More than $100 million is still going to be an investment on the MRD side. There's the cost of running the test, there's the cost of generating the clinical data, there's the sales and marketing effort. So we're still making heavy investments on the MRD side.

也許只是為了對我們指引的 3.2 億至 3.3 億美元的整體現金消耗情況進行一些說明。你可以從不同的角度來看待它。大約2億美元用於篩選。對此我們已經非常明確了。MRD 的投資仍將超過 1 億美元。有運行測試的成本，有產生臨床數據的成本，有銷售和行銷工作的成本。因此，我們仍在 MRD 方面進行大量投資。

And then from a CapEx perspective, as we continue to increase capacity and automation, we're probably going to spend around $40 million on CapEx in 2024. So that more than covers the overall cash burn, free cash flow that we've spoken about. And so we will start to see positive cash in 2024 from therapy selection. And I think, yeah, as the revenue grows, again, a lot of that's going to start to drop down to the bottom line. So we'll start to generate some significant cash from that business over the next few years.

然後從資本支出的角度來看，隨著我們繼續提高產能和自動化程度，我們可能會在 2024 年在資本支出上花費約 4000 萬美元。因此，這不僅僅是我們所謂的整體現金消耗、自由現金流。因此，我們將在 2024 年開始從治療選擇中看到積極的現金。我認為，是的，隨著收入的增長，其中許多將開始下降到底線。因此，我們將在未來幾年開始從該業務中產生大量現金。

(Operator Instructions) Eve Burstein, Bernstein Research.

（操作員說明）Eve Burstein，伯恩斯坦研究中心。

Hi, there. Thanks a lot for taking the questions. Two on Shield. The first is, you've modeled and talked a lot about the importance of adherence and quantifying the benefit of clerical cancer screening. And in the study that you highlighted today, you showed that you have better adherence. So even if Shield has sensitivity and specificity that aren't quite best-in-class versus other modalities, you could still have best-in-class impact.

你好呀。非常感謝您提出問題。盾牌上有兩個。首先，您已經建模並討論了許多關於堅持和量化子宮頸癌篩檢益處的重要性。在您今天強調的研究中，您表明您有更好的依從性。因此，即使 Shield 的敏感性和特異性與其他方式相比並不是一流的，您仍然可以產生一流的影響。

However, in the past, the USPSTF has used models that assume 100% adherence rate for all screening modalities. So to some extent, for Shield to score well, USPSTF will have to fundamentally change the methodology that they've used in the past. So what conversations have you had or data points can you share that give you confidence that this will happen?

然而，過去，USPSTF 使用的模型假設所有篩檢方式的遵守率為 100%。因此，在某種程度上，為了讓 Shield 取得好成績，USPSTF 必須從根本上改變他們過去使用的方法。那麼，您進行過哪些對話或可以分享哪些數據點讓您相信這將會發生？

And then quick follow-up question on the investment in field force that you've laid out for Shield. Are any of those gated by getting first or second-line therapy approval for FDA or a recommendation for USPSTF?

然後是關於您為 Shield 部署的現場部隊投資的快速後續問題。其中是否有任何藥物需要獲得 FDA 的一線或二線治療批准或 USPSTF 的建議？

Yeah, sure. Thanks. This is a great question. So adherence is definitely the value of a -- having a patient-friendly modality, which generates pleasant experience to complete that test. If we didn't have the issue of adherence, we wouldn't have 50 million on-screen patients. We wouldn't have 76% death rate coming from on-screen patient population or the people who are not up-to-date with cancer screening.

是的，當然。謝謝。這是一個很好的問題。因此，堅持絕對是一種對患者友好的方式的價值，它可以為完成測試帶來愉快的體驗。如果我們沒有依從性問題，螢幕上就不會有 5000 萬患者。我們不會看到 76% 的死亡率來自螢幕上的患者群體或未及時進行癌症篩檢的人群。

So in terms of the impact, the awareness is pretty high. We are not at a stage that we can have conversation with USPSTF members. But having said that, we've been in touch with some advisors. The former scientific director of USPSTF has been very vocal in this field now. And it looks kind of common sense that when the issue in this CRC screening is lack of adherence, frankly, people are not completing the test. You need to have that perspective in mind when you're evaluating this test in terms of life-year gains and outcome benefits.

所以從影響力來說，認知度是相當高的。我們還沒有到可以與 USPSTF 成員進行對話的階段。但話雖如此，我們已經與一些顧問保持了聯繫。這位USPSTF的前科學主任現在在這個領域非常有發言權。坦白說，當這次 CRC 篩檢中的問題是缺乏依從性時，人們沒有完成測試，這看起來是常識。當您根據生命年收益和結果效益來評估此測試時，您需要牢記這一觀點。

Regarding the first line and second line, in general, what we believe is this. In order to build a multi-billion dollar brand, we need FDA approval for Shield. Obviously, first line is better, but second line is actually a very good option for us. And let me put that in some context for you.

關於第一行和第二行，總的來說，我們認為是這樣的。為了打造一個價值數十億美元的品牌，我們需要 FDA 批准 Shield。顯然，第一線更好，但第二線對我們來說實際上是一個非常好的選擇。讓我為您介紹一下這一點。

There are 120 million people in the US who are eligible for colon cancer screening, right? Out of this 120 million, 55 million are getting screening through colonoscopy, and 15 million are getting screened by stool tests. So we have about 50 million on-screen patient population. Effectively, although the first line indication is for all 120 million, but the reality, the commercial opportunities, these tests are not going to replace colonoscopy and reduce the rate of colonoscopy versus being complementary.

美國有 1.2 億人有資格接受大腸癌篩檢，對嗎？在這 1.2 億人中，有 5500 萬人透過大腸鏡檢查進行篩檢，1500 萬人透過糞便檢查進行篩檢。所以我們螢幕上有大約 5000 萬患者群體。實際上，雖然第一線適應症適用於所有 1.2 億人，但現實、商業機會、這些測試不會取代大腸鏡檢查，也不會降低大腸鏡檢查的比率，而不是作為補充。

So as a result, what we are expecting and what we are seeing in the marketplace is the market size for first line testing would be for, let's say, 65 million people, and market size for second line would be for 50 million people. Other thing that maybe would be interesting to note, just look at the re-screening rates that's happening right now with stool-based tests. They're pretty low. Like the overall adherence rate to fit over three years is about 10% to 20%. Re-screening rate with Cologuard is also low after all these rates, after all these years.

因此，我們所期望的以及我們在市場上看到的情況是，一線測試的市場規模將適合 6500 萬人，二線測試的市場規模將適合 5000 萬人。其他可能值得注意的事情，只要看看現在基於糞便的測試所發生的重新篩檢率。他們的水平相當低。三年內的整體遵守率約為 10% 至 20%。經過這麼多年，Cologuard 的重新篩檢率也很低。

In fact, these are matching the consumer survey findings that we showed before, that seven out of 10 people who've done stool-based testing, they don't want to do it again. So the opportunity for stool tests to really grow to this 50 million on-screen patient population is pretty limited, and their test is not sticky.

事實上，這些與我們之前展示的消費者調查結果相符，即十分之七的做過糞便檢測的人不想再做一次。因此，糞便測試真正擴展到螢幕上這 5000 萬患者群體的機會相當有限，而且他們的測試不具有黏性。

As a result, we believe there is a huge opportunity for patient-friendly that can be done and completed even in the office, enabled by this blood-based screening modality. So that's the context of why we think even a second-line indication for Shield can be a huge opportunity for us, as long as we get FDA approval.

因此，我們相信，透過這種基於血液的篩檢方式，即使在辦公室也可以完成患者友善篩檢的巨大機會。因此，這就是為什麼我們認為只要獲得 FDA 的批准，即使 Shield 的二線適應症對我們來說也可能是一個巨大的機會。

(Operator Instructions) Dan Brennan, TD Cowen.

（操作員說明）Dan Brennan，TD Cowen。

Great. Thank you. Thanks for the questions. So the first one is just on the revenue guide back there, 16% to 19%. I know you're coming off a year of 25% growth, and your ASPs are going up. So just wondering if you can provide any color, maybe kind of what would get you towards the bottom end of that range? Are you baking in real conservatism and pharma or clinical? Maybe just any color that you can provide there.

偉大的。謝謝。感謝您的提問。所以第一個就在後面的收入指南上，16% 到 19%。我知道你們今年將實現 25% 的成長，而且你們的平均售價也在上升。所以只是想知道你是否可以提供任何顏色，也許什麼會讓你達到該範圍的底部？您是在真正的保守主義和製藥還是臨床中烘焙？也許只是您可以在那裡提供的任何顏色。

And then the second one was just on reveal. I know you said you're not baking in anything for CRC or very modest for breast, but can you just give us some color on kind of what the overall volumes were in '23 and timing and confidence for getting MolDX approvals in those two new indications during '24? Thank you.

然後第二個剛剛揭曉。我知道你說過你不會為CRC 烘焙任何東西，也不會為乳房烘焙任何東西，但你能否給我們一些關於23 年總產量的信息，以及在這兩個新產品中獲得MolDX 批准的時機與信心'24期間的跡象？謝謝。

Yeah, I can take a breakdown of the growth. Yeah, maybe just to give a little bit more color on the guide across the different lines. I'll start with development services. That's a very lumpy line, swings around quite a lot. But for the year, we expect it's going to be relatively flat against 2023. And so that implies that -- that's sort of the midpoint, the precision oncology line, which is clinical and biopharma testing. That's going to grow at around 20% year-over-year.

是的，我可以將成長細分。是的，也許只是為了在不同線路的指南上提供更多的色彩。我將從開發服務開始。這是一條非常崎嶇的線，擺動幅度很大。但就今年而言，我們預計與 2023 年相比將相對持平。這意味著——這就是中間點，精準腫瘤學線，即臨床和生物製藥測試。預計將年增 20% 左右。

And maybe breaking that further, biopharma, we expect, as we did last year, to see some sort of low double digit growth on the biopharma. We have a very strong, we finished the year strong. We've gone into 2024 with a very strong pipeline. I think we just want to be continually conservative on that line. We see a lot of other companies being impacted by biopharma spend. And so I think this sort of low double digit expectation where we're on the conservative side.

也許會進一步打破這一點，生物製藥，我們預計，就像我們去年所做的那樣，生物製藥將出現某種低兩位數的增長。我們非常強大，我們以強大的實力結束了這一年。進入 2024 年，我們擁有非常強大的產品線。我認為我們只是想在這方面繼續保持保守。我們看到許多其他公司受到生物製藥支出的影響。所以我認為這種低兩位數的期望是我們持保守態度的。

And if you sort of put all those together, it implies clinical revenue growth of at least 20%. So we still look at that as being very strong with plenty of upside that could come on that clinical revenue growth. And maybe just one other thing on the cadence of the growth. I think it's important to know that we always have this seasonality in Q4 where we have very strong biopharma revenue.

如果你把所有這些加在一起，這意味著臨床收入至少成長 20%。因此，我們仍然認為這一點非常強勁，臨床收入成長可能帶來很大的上行空間。也許這只是成長節奏的另一件事。我認為重要的是要知道我們在第四季度總是有這種季節性，我們擁有非常強勁的生物製藥收入。

And then that always, as companies or customers push through their budgets at the end of the year. And we know that sequentially biopharma revenue is always lowering in Q1. So even though we'll have an uplift of G360 ASP in Q1, we still expect the overall revenue sequentially to be lowering in Q1 versus Q4 of 2023. And then throughout the year, we expect it to sort of sequentially grow in each quarter. So yeah, hopefully that's given some additional color on that guide. And Ali?

然後，隨著公司或客戶在年底完成預算，情況總是如此。我們知道，第一季生物製藥收入總是在下降。因此，儘管我們第一季 G360 的平均售價將有所提升，但我們仍然預計 2023 年第一季的整體營收將比第四季有所下降。然後全年，我們預計每個季度都會連續成長。所以是的，希望這能為指南帶來一些額外的色彩。阿里呢？

Yeah, in terms of MRD, we're preparing publications as we speak, at least in CRC. And then we'll get the rest publication out, at least in submitted as soon as we can. And really the gating item is going to be time to getting those published and the sort of back and forth with multii- years in terms of submitting that data.

是的，就 MRD 而言，我們正在準備出版物，至少在 CRC 中。然後我們將發布其餘的出版物，至少盡快提交。實際上，門控項目將是發布這些數據的時間，以及在提交這些數據方面需要多年的時間。

Obviously, we haven't really baked much in this year in terms of this additional reimbursement that is certainly upside if we manage to sort of get through the gauntlet there quickly. I would also say that, you know, I think we feel very good about the core business in general. We built, I would say, a lot of potential catalysts over the last 18 months into the business.

顯然，今年我們在額外報銷方面並沒有真正做出太多努力，如果我們能夠迅速度過難關，這肯定是有好處的。我還想說，我認為我們對核心業務整體感覺非常好。我想說，在過去 18 個月的業務發展中，我們建立了許多潛在的催化劑。

We have the partnerships with large group practices like US Oncology, the EMR integrations, smart liquid biopsy transition, some of the upgrades to TissueNext. And a lot of that, I think, is potential upside in terms of where we are. So, we feel very good, including around the competitive landscape that's there.

我們與美國腫瘤學、EMR 整合、智慧液體活檢過渡、TissueNext 的一些升級等大型團體實踐建立了合作夥伴關係。我認為，就我們目前的情況而言，其中許多都是潛在的好處。所以，我們感覺非常好，包括那裡的競爭格局。

(Operator Instructions) Jack Meehan with Nephron Research.

（操作員說明）Nephron Research 的 Jack Meehan。

Thanks. Good afternoon. I had a couple of gross margin questions. First for Mike, if you include the dilution from Shield, what is the guide assumed for gross margins for the year? Any implications for Shield volume growth embedded? And for Helmy, I was wondering if you could talk about your sequencing strategy. Are there any changes you're planning to make in the labs, either with Novax or something, just to help drive savings on the COGS side? Thanks.

謝謝。午安.我有幾個毛利率問題。首先，對於麥克來說，如果包括 Shield 的稀釋，那麼今年毛利率的假設指南是多少？對嵌入的 Shield 數量成長有何影響？至於 Helmy，我想知道你是否可以談談你的定序策略。您是否計劃在實驗室中進行任何更改（無論是透過 Novax 還是其他方式），以幫助節省 COGS 方面的費用？謝謝。

Yeah, Jack, on the gross margin side, I think we really want to focus where the gross margins are going to be on the business, excluding screening. In 2023, we saw something like a 2-percentage-point impact overall from running the shield LDT tests. And again, we get very minimal revenue for those. And so far, for 2024, we've given the guidance of the gross margins without screening at 60% to 62%.

是的，傑克，在毛利率方面，我認為我們真的想把重點放在業務的毛利率上，不包括放映。2023 年，我們看到運行盾 LDT 測試的整體影響大約是 2 個百分點。再說一遍，我們從中獲得的收入非常少。到目前為止，對於2024年，我們給出的未經篩選的毛利率指引為60%至62%。

So hopefully people can then start to really understand the performance of the business without screening. It's going to be difficult for us to say what the impact is going to be throughout 2024 on screening. Obviously, it's going to depend on the volume. It's going to depend on the timing of FDA approval and launch, and then what that volume ramp is going to be. And it's also going to be dependent on when we get the initial Medicare gap fill rates and what that rate is going to be at.

因此，希望人們能夠開始真正了解企業的績效，而無需進行篩選。我們很難說 2024 年全年的放映會產生什麼影響。顯然，這將取決於音量。這將取決於 FDA 批准和上市的時間，以及銷售量的成長。這也將取決於我們何時獲得最初的醫療保險缺口填補率以及該比率的水平。

So that's why we really want to focus on gross margin without screening because it's difficult to measure. But again, I think our aim, excluding screening, is to be at least 60% gross margins. And I think we feel comfortable with all of the mixed impacts across the core business that we can manage to that level.

這就是為什麼我們真正希望在不進行篩選的情況下關注毛利率，因為它很難衡量。但我再次強調，不包括篩選在內，我們的目標是至少達到 60% 的毛利率。我認為我們對我們能夠管理到這一水平的核心業務的所有混合影響感到滿意。

Yeah, in terms of sequencing, I would say just in general, we have a pretty robust program around COGS production. And I think there's going to be some, I think, good opportunities over the next couple of years, especially with some of the investments we're making in terms of Shield and really the infrastructure there that is going to, I think, pay dividends on the oncology side as well. And we're certainly pursuing some of the lower cost sequencing instruments such as [Novozymes] and others that may lower our overall COGS of running our tests

是的，就排序而言，我想說的是，總的來說，我們有一個圍繞銷貨成本生產的非常強大的計劃。我認為未來幾年將會有一些很好的機會，特別是我們在 Shield 方面進行的一些投資以及那裡的基礎設施，我認為這些投資將會帶來紅利在腫瘤學方面也是如此。我們當然正在尋求一些成本較低的定序儀器，例如 [Novozymes] 和其他可能降低運行測試的總體成本的儀器

(Operator Instructions) Doug Schenkel, Wolfe Research.

（操作員說明）Doug Schenkel，Wolfe Research。

Hey, good afternoon. I want to ask a high level question and then kind of a related follow-up as it relates to Shield. So there's clearly questions in the investor and medical community about how Guardant is managing trial design timelines, how you describe complexity of moving from things like V1 to V2, the level of attenuation we see in post-case controlled studies, et cetera.

嘿，下午好。我想問一個高級問題，然後提出與 Shield 有關的相關後續問題。因此，投資者和醫學界顯然對 Guardant 如何管理試驗設計時間表、如何描述從 V1 到 V2 等的複雜性、我們在病例後對照研究中看到的衰減水平等存在疑問。

Fair or not, this is out there, and I think it's fair to say this is a big reason why your stock price is where it is. A new year is a good time for new resolutions. What do you think you can do better? And what steps are you taking to get back that management premium that used to exist in the stock?

不管公平與否，這都是事實，而且我認為可以公平地說，這是你的股價達到目前水準的一個重要原因。新的一年是製定新計劃的好時機。您認為自己可以在哪些方面做得更好？您將採取哪些措施來收回股票中曾經存在的管理溢價？

And then my follow-up on Shield, there's a range of outcomes for Shield in terms of how things go with the FDA, how things go with CMS and private payers, how you're viewed by USPSTF, how you're viewed by the folks that set guidelines. Even in better scenarios, this is a very expensive program with a really long runway. Under what scenario would you consider discontinuing or spinning off screening? Thank you.

然後是我對 Shield 的後續報道，Shield 會產生一系列結果，包括 FDA 的處理方式、CMS 和私人付款人的處理方式、USPSTF 如何看待您、制定指導方針的人。即使在更好的情況下，這也是一個非常昂貴的項目，並且跑道很長。在什麼情況下您會考慮停止或剝離放映？謝謝。

Yeah, actually, very good question, Doug. So it's a fair question, frankly, and I accept that and you're right. I think a bunch of people out there are right. I think the reality is we are going to focus on execution and show that hopefully this FDA approval would come. And ADLT status would come and a successful commercial launch would come. And over time, I think that performance is going to generate confidence that -- hey, when these guys Amirali was talking about blood-based CRC screening has huge potential, even with the performances that we've seen with V1, that becomes more of a reality versus just betting on what this guy is talking about.

是的，實際上，這是一個很好的問題，道格。坦白說，這是一個公平的問題，我接受這一點，你是對的。我認為外面有很多人是對的。我認為現實是我們將專注於執行並表明希望 FDA 能夠批准。ADLT 狀態將會到來，商業發布也會成功。隨著時間的推移，我認為這種表現將產生信心——嘿，當這些人 Amirali 談論基於血液的 CRC 篩檢具有巨大潛力時，即使我們在 V1 上看到了表現，這也變得更加現實而不是僅僅押注這個人在說什麼。

Definitely, there are some kind of feedback that I accept in terms of there were some bars of what a successful CRC screening would be to make a multi-billion dollar brand. And that bar versus the data that we've seen before on blinding the database was the delta was very big and we ended up somewhere in the middle. So I think that expectation management can be done in a much more, in a different way. So I accept that.

當然，我接受一些回饋，即成功的 CRC 篩檢對於打造價值數十億美元的品牌有一定的幫助。與我們之前在致盲資料庫中看到的資料相比，該條的增量非常大，我們最終處於中間的某個位置。所以我認為期望管理可以透過更多、不同的方式來完成。所以我接受這一點。

Shield, in terms of our commitment with Shield, I would tell you, like we are not here to waste our life doing something that we don't believe and just burn the money because, we have the optionality of burning that money. I would tell you, if we figure out that this brand is not going to have the commercial impact that we believe it will have, there would be no Shield.

盾牌，就我們對盾牌的承諾而言，我會告訴你，就像我們來這裡不是為了浪費生命做一些我們不相信的事情，然後燒錢，因為我們可以選擇燒錢。我想告訴你，如果我們發現這個品牌不會產生我們相信的商業影響，就沒有盾牌了。

So we mentioned always that we have milestones and gateways. The first one for us is this FDA approval and getting this FDA approval. That's just the first. The second one is trying that we can generate this business in a proper way by showing commercial success and so forth. So we have all these milestones that we are going to meet and as long as we meet those, Shield would continue and would generate multi-billion dollar opportunity to Guardant and P&L in the years to come.

所以我們總是提到我們有里程碑和門戶。對我們來說第一個是 FDA 的批准並獲得 FDA 的批准。這只是第一個。第二個是嘗試透過展示商業成功等方式以適當的方式來開展這項業務。因此，我們即將實現所有這些里程碑，只要我們實現這些里程碑，Shield 就會繼續下去，並在未來幾年為 Guardant 和 P&L 創造數十億美元的機會。

So we are not here to waste our time or your time just playing with Shield here. We have better things to do in life, frankly. (multiple speakers) But the belief is very, very strong. We are a very strong believer on the potential here.

所以我們來這裡不是為了浪費我們的時間或你的時間只是在這裡玩盾牌。坦白說，我們生活中有更美好的事情要做。（多名發言者）但是信念非常非常強烈。我們堅信這裡的潛力。

(Operator Instructions) Rachel Vatnsdal, JPMorgan Chase & Co.

（操作員指示）Rachel Vatnsdal，摩根大通公司

Hi, great. This is Casey. I'm for Rachel. Just can you guys talk about where things stand on the EMR integration front? You noted 475 accounts now integrated, which was above your goal of 400 to end the year. You know, can you contextualize that number as a percentage of total accounts or total accounts that were eligible for integration? And then maybe walk us through how you see those 475 accounts scaling up volumes over the course of the year?

嗨，太好了。這是凱西。我是為了雷切爾。你們能談談 EMR 整合方面的情況嗎？您注意到現已整合了 475 個帳戶，這超出了您年底時 400 個帳戶的目標。您知道，您能否將該數字視為佔總帳戶數或有資格整合的總帳戶數的百分比？然後也許可以向我們介紹一下您如何看待這 475 個帳戶在一年中擴大交易量的情況？

Yeah, I mean, I don't think we're going to break out the sort of number in a sort of percentage of volume, but it is a significant percentage of our volume right now. So we're very pleased in terms of where we are. What we're seeing is really, I think, significant uplift in those accounts as they turn on.

是的，我的意思是，我認為我們不會以某種數量百分比來打破這種數字，但它現在占我們數量的很大一部分。因此，我們對目前的情況感到非常滿意。我認為，我們所看到的是，隨著這些帳戶的開通，它們的數量確實顯著增加。

There is a lot of engagement that happens at that count level, a lot of retraining, and it just makes life so much simpler when they can essentially use their existing EMR system of record to just order the test and get the results back.

在該計數層級上會發生大量的參與和大量的再培訓，當他們基本上可以使用現有的 EMR 記錄系統來訂購測試並獲取結果時，生活就會變得更加簡單。

And so we think we're very pleased with the progress we've made. We're seeing really a significant jump in terms of ordering rates in those accounts, but it is also early days. It's something that we sort of got to at the end of last year, and I think we're going to see the dividends of that work we've done pay off over this year and next. We're still making very good progress in terms of the rest of the accounts.

因此，我們認為我們對所取得的進展感到非常滿意。我們看到這些帳戶的訂購率確實出現了顯著的躍升，但現在還處於早期階段。這是我們去年年底所做的事情，我認為我們將看到我們所做的工作在今年和明年得到回報。就其餘帳戶而言，我們仍然取得了很好的進展。

[Epic] is a sort of slower process where each one of the hospitals and sort of accounts has to be turned on at their level, and we're increasing our pipeline there so that we can go as fast as possible. But I'm very pleased with the progress the team has made, and it's certainly one of the, I think, potential upside drivers of volume this year.

[Epic] 是一種較慢的過程，每個醫院和各種帳戶都必須在其級別上打開，我們正在增加我們的管道，以便我們可以盡快進行。但我對團隊的進展感到非常滿意，我認為這無疑是今年銷售的潛在上行驅動因素之一。

(Operator Instructions) Andrew Cooper, Raymond James.

（操作員說明）安德魯庫柏、雷蒙詹姆斯。

Hey, everybody. Thanks for the question. Maybe just one more on MRD and the breast data you disclosed in preparation there. I just would love your thoughts given kind of how we think about different subsets of that breast cancer population and some lower shedding sort of subsets in terms of the ctDNA. How do we think about that in context of some of the numbers we see out there, whether from others, when it's a certain subset or not. And how that 97% specificity and the, I think it was 82% or 84% sensitivity sort of stack up. And then lastly, just you say that data is going to be included in your eventual submission. Is there any additional data you think you need before you submit to CMS for coverage, or do we just need to see kind of the current studies published? Thanks.

嘿，大家。謝謝你的提問。也許只是再提供一份關於 MRD 以及您在準備過程中披露的乳房數據的資訊。我只是想聽聽您的想法，了解我們如何看待乳癌族群的不同子集以及 ctDNA 方面一些脫落率較低的子集。我們如何在我們看到的一些數字的背景下思考這個問題，無論是來自其他數字，還是某個子集。97% 的特異性和我認為 82% 或 84% 的敏感性是如何疊加的。最後，您說數據將包含在您最終提交的內容中。在提交給 CMS 進行報告之前，您認為需要任何其他資料嗎？謝謝。

Yeah, no, thanks for the question. I'll maybe start with the second one. Now, we believe this is more than sufficient in terms of data for sort of clinical validity from a Medicare perspective. It's a fairly sizable cohort. I think much, much larger than other publications we've seen. And has a good number of sort of time points. It does have -- I think very good diversity across subtypes of breast cancer.

是的，不，謝謝你的提問。我也許會從第二個開始。現在，我們相信，從醫療保險的角度來看，這對於臨床有效性的數據來說已經足夠了。這是一個相當大的群體。我認為比我們見過的其他出版物大得多。並且有很多時間點。我認為乳癌亞型之間確實具有很好的多樣性。

You're right. Different cancer types and breast cancer, different subtypes have different shedding levels. And when we've looked at the breakdown there in terms of triple-negative or HER2-positive or HER2-negative and so on, we've seen very good performance as well there. So even on a sort of subtype by subtype level, we see -- I think, really industry-leading kind of performance. It's the same thing on the CRC side.

你說得對。不同的癌症類型和乳癌、不同的亞型有不同的脫落程度。當我們查看三陰性、HER2 陽性或 HER2 陰性等方面的細分時，我們也看到了非常好的表現。因此，即使在逐個子類型層級上，我們也看到了——我認為，真正行業領先的性能。CRC 方面也是同樣的情況。

Depending on the site of metastasis, there's different shedding rates. And no method really solves that. That's just a factor of the biology in terms of the tumor type. And so that's why these results, typically hold -- if it performs well in one subtype, it potentially performs well in other subtypes just because of the fact that you're detecting more alterations or detecting those alterations at lower levels. But right now, there's not a way to solve the sort of different shedding levels. That's a factor of the biology of the tumor.

根據轉移部位的不同，脫落率也不同。沒有任何方法可以真正解決這個問題。這只是腫瘤類型的生物學因素。這就是為什麼這些結果通常成立——如果它在一種亞型中表現良好，那麼它可能在其他亞型中表現良好，只是因為您檢測到更多的變化或檢測到較低水平的這些變化。但目前還沒有辦法解決不同脫落程度的問題。這是腫瘤生物學的因素。

Thank you for your question. That concludes today's call. Thank you for your participation and enjoy the rest of your day.

謝謝你的提問。今天的電話會議到此結束。感謝您的參與，祝您有個愉快的一天。