Guardant Health Inc (GH) 2024 Q3 法說會逐字稿

Hello, everyone, and welcome to the Guardant Health Q3 2024 earnings call. My name is Nadia, and I'll be coordinating the call today. (Operator Instructions)

大家好，歡迎參加 Guardant Health 2024 年第三季財報電話會議。我叫納迪亞，今天我將負責協調通話。（操作員說明）

I will now hand over to your host, Zarak Khurshid, Vice President of Investor Relations, to begin. Zarak, please go ahead.

現在請主持人投資者關係副總裁 Zarak Khurshid 開始發言。扎拉克，請繼續。

Thank you. Earlier today, Guardant Health released financial results for the quarter ended September 30, 2024. 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 2024 年 9 月 30 日的季度財務業績。今天與我一起加入 Guardant 的是聯合執行長 Helmy Eltoukhy； AmirAli Talasaz，聯合執行長；和首席財務官邁克·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 securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated.

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

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

這次電話會議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。有關重大風險和不確定性以及與最直接可比的 GAAP 財務指標的非 GAAP 調節的更多信息，請參閱 Guardant 今天發布的新聞稿以及我們向 SEC 提交的 10-K 和其他文件。

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, except as required by law. The information in this conference call is accurate only as of the live broadcast.

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，除非法律要求。本次電話會議中的資訊僅截至直播時準確。

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

有了這個，我想把電話轉給 Helmy。

Thanks, Zarak. Good afternoon and thank you for joining our third quarter 2024 earnings call. Starting on slide 3. 12 years ago, we embarked on our mission to conquer cancer with data. Roughly two years later, we launched into the late-stage cancer market with our first version of Guardant360 in 2014.

謝謝，札拉克。下午好，感謝您參加我們的 2024 年第三季財報電話會議。從投影片 3 開始。大約兩年後，我們在 2014 年推出第一版 Guardant360，進入晚期癌症市場。

In 2021, we launched Guardant Reveal for cancer recurrence and monitoring. And this past quarter, on August 1, we were thrilled to launch our first test into the asymptomatic cancer screening market with Shield, unlocking an exciting opportunity to potentially impact millions more individuals across the cancer continuum. As is our practice, I would like to start our call off with a story illustrating the important impact our test can have on improving patients' lives.

2021 年，我們推出了 Guardant Reveal，用於癌症復發和監測。上個季度，也就是 8 月 1 日，我們很高興透過 Shield 向無症狀癌症篩檢市場推出了首次測試，釋放了一個令人興奮的機會，可能會影響數百萬癌症患者。按照我們的慣例，我想以一個故事開始我們的會議，說明我們的測試對改善患者生活的重要影響。

A woman was initially diagnosed with left breast cancer when she was 50 years old. With a family history of cancer, she opted for an aggressive treatment and underwent a double mastectomy. A few years later, she began experiencing hip and lower back pain. After a doctor determined the breast cancer had metastasized, a Guardant360 liquid biopsy test was ordered to determine if the metastasis had any actionable biomarkers. An ESR1 mutation was revealed, and she was placed on elacestrant for therapy. The Guardant360 test report also noted a BRCA2 variant, which was later confirmed to be a germline mutation after further testing in a specialized lab. As a result, her family underwent genetic testing, and her sister was found to carry the same BRCA2 germline mutation but had not experienced a cancer diagnosis to date. Her sister chose a prophylactic double mastectomy and oophorectomy as treatment and was found to have occult ovarian cancer. This case highlights the remarkable ability of Guardant360 to provide life-saving information, both for patients with symptoms and for those without.

一名女性在 50 歲時首次被診斷出患有左側乳癌。由於有癌症家族史，她選擇了積極的治療並接受了雙乳切除手術。幾年後，她開始出現臀部和腰部疼痛。醫生確定乳癌已轉移後，要求進行 Guardant360 液體活檢測試，以確定轉移灶是否有任何可操作的生物標記。發現了 ESR1 突變，她接受了 elacestrant 治療。Guardant360的測試報告也指出了BRCA2變異，後來經過專門實驗室的進一步測試，確認為種系突變。結果，她的家人接受了基因檢測，她的姐姐被發現攜帶相同的 BRCA2 種系突變，但迄今為止尚未經歷過癌症診斷。她的姐姐選擇了預防性雙乳切除術和卵巢切除術作為治療，並被發現患有隱匿性卵巢癌。此案例凸顯了 Guardant360 為有症狀和無症狀的患者提供挽救生命資訊的卓越能力。

Turning to top line performance on slide 4. We continued our strong momentum into the third quarter with total revenue growing 34% to a record $191.5 million. This was driven by another quarter of robust precision oncology revenue, which increased 35% in the quarter, supported by significant Guardant360 reimbursement tailwinds and broad-based volume growth fueled by our Smart Liquid Biopsy transition.

轉向幻燈片 4 上的頂線表現。第三季我們持續保持強勁勢頭，總營收成長 34%，達到創紀錄的 1.915 億美元。這是由另一個季度強勁的精準腫瘤學收入推動的，該收入在本季度增長了 35%，這得益於 Guardant360 報銷的巨大推動力以及我們的智能液體活檢轉型推動的廣泛銷量增長。

Turning to slide 5. Clinical test volume for the third quarter grew 21% year-over-year and 7% quarter-over-quarter, reaching 53,100 tests, driven by strength across the portfolio. In particular, Guardant360 performed extremely well in Q3 and grew mid-single digits sequentially. Furthermore, Reveal continues to see strong growth even with our ongoing careful management of volumes ahead of broader reimbursement. As a reminder, our clinical test volume is specific to our oncology tests, which are Guardant360, TissueNext, Response, and Reveal and does not include screening test volumes from Shield.

轉到投影片 5。在整個產品組合實力的推動下，第三季的臨床測試量年增 21%，季增 7%，達到 53,100 項測試。尤其是 Guardant360 在第三季的表現非常出色，並連續實現中個位數成長。此外，儘管我們在更廣泛的報銷之前持續仔細管理數量，但 Reveal 仍繼續強勁增長。提醒一下，我們的臨床測試量是特定於我們的腫瘤學測試，即 Guardant360、TissueNext、Response 和 Reveal，不包括 Shield 的篩選測試量。

Q3 was another standout quarter for biopharma with volumes up 40% year-over-year to a record 10,500 tests. I will share some more details on our biopharma progress shortly. Looking more closely at some of the recent highlights within our therapy selection business on slide 6. In late July, we launched our upgraded Guardant360 LDT and Smart Liquid Biopsy, representing the most significant upgrade to our flagship precision oncology product. Guardant360 is the leading liquid biopsy test for patients with advanced cancer with industry-leading turnaround time and the improved platform positions us for continued robust growth and share gain.

第三季度是生物製藥領域另一個表現優異的季度，測試量年增 40%，達到創紀錄的 10,500 項測試。我將很快分享有關我們生物製藥進展的更多細節。更仔細地查看幻燈片 6 中我們的治療選擇業務中最近的一些亮點。7月下旬，我們推出了升級版的Guardant360 LDT和智慧液體活檢，這是我們旗艦精準腫瘤產品最重大的升級。Guardant360 是針對晚期癌症患者的領先液體活檢測試，具有業界領先的周轉時間，改進的平台使我們能夠持續強勁成長和份額成長。

The Guardant360 upgrade expands the number of genes by nearly tenfold, includes all guideline recommended genomic markers for solid tumors, improves the sensitivity for tumor burden detection by a factor of 10 and introduces the first feature enabled by our methylation tech stack in therapy selection. As the performance and richness of the Guardant360 LDT product evolves and we continue to generate clinical data and add features, oncologists will gain an unparalleled view of cancer that we believe will quickly become a new standard of care in the clinical management of advanced cancer patients. Due to this compelling upgrade, we are very pleased that we are already seeing an increase in both breadth and depth of accounts and believe this will continue to drive growth as additional capabilities are unlocked over time. In particular, Guardant360 LDT on Smart Liquid Biopsy was the strongest contributor to year-over-year and sequential volume growth in the third quarter. We also saw continuing improvements in Guardant360 ASPs, which reached $3,000 in the third quarter.

Guardant360 升級將基因數量增加了近十倍，包括實體瘤的所有指南建議的基因組標記，將腫瘤負荷檢測的靈敏度提高了10 倍，並引入了我們的甲基化技術堆疊在治療選擇中啟用的第一個功能。隨著 Guardant360 LDT 產品性能和豐富性的發展，以及我們不斷生成臨床數據和添加功能，腫瘤學家將獲得無與倫比的癌症視角，我們相信這很快就會成為晚期癌症患者臨床管理的新護理標準。由於這項引人注目的升級，我們非常高興地看到客戶的廣度和深度都在增加，並相信隨著時間的推移，隨著更多功能的釋放，這將繼續推動成長。特別是，智慧液體活檢的 Guardant360 LDT 是第三季度同比和環比銷量成長的最大貢獻者。我們也看到 Guardant360 ASP 持續改進，第三季達到 3,000 美元。

Last quarter, we shared the upgrade of our TissueNext test to identify more treatment options for patients with advanced cancer. We have seen strong interest in the expanded panel and are excited to share that effective January 1, 2025, Medicare pricing will increase from $3,100 to $3,500. Following these great updates, I'm excited to share that we again generated positive free cash flow in our therapy selection business in the third quarter. We also announced a partnership with Policlinico Gemelli in Rome, a leading European oncology center to implement on-site processing of Guardant360 CDx tests for therapy selection in advanced cancer patients. This will mark one of the first dedicated liquid biopsy testing facilities housed within a hospital system in Italy.

在上季度，我們分享了 TissueNext 測試的升級，以便為晚期癌症患者找到更多治療選擇。我們看到人們對擴大的小組產生了濃厚的興趣，並很高興地告訴大家，自 2025 年 1 月 1 日起，醫療保險定價將從 3,100 美元上漲至 3,500 美元。在這些重大更新之後，我很高興與大家分享，我們在第三季的治療選擇業務中再次產生了正的自由現金流。我們還宣布與歐洲領先的腫瘤中心羅馬 Policlinico Gemelli 建立合作夥伴關係，對 Guardant360 CDx 測試進行現場處理，以用於晚期癌症患者的治療選擇。這將標誌著義大利醫院系統內首批專用液體活檢檢測設施之一。

This partnership is significant given there are approximately 400,000 new malignant tumor cases recorded annually across Italy. When implemented, oncologists in Italy will be able to access our tests to make more informed treatment decisions for patients with solid tumor cancers. Finally, results from the SCRUM-Japan GOZILA study were recently published in Nature Medicine, demonstrating the significant survival benefits of using Guardant360 CDx to test patients with advanced gastrointestinal cancer. Of the 4,037 patients in the study, 24% received personalized targeted treatment based on Guardant360 CDx, and this subgroup survived nearly twice as long as those who did not receive Guardant360 match therapy. This study further solidifies the clinical utility of Guardant360 in guiding effective treatment decisions for advanced cancer patients.

鑑於義大利每年約有 40 萬新發惡性腫瘤病例，此次合作意義重大。實施後，義大利的腫瘤學家將能夠存取我們的測試，為實體瘤患者做出更明智的治療決策。最後，SCRUM-Japan GOZILA 研究的結果最近發表在 Nature Medicine 上，證明使用 Guardant360 CDx 測試晚期胃腸道癌症患者俱有顯著的生存益處。在該研究的 4,037 名患者中，24% 接受了基於 Guardant360 CDx 的個人化標靶治療，該亞組的存活時間是未接受 Guardant360 匹配治療的患者的近兩倍。這項研究進一步鞏固了 Guardant360 在指導晚期癌症患者的有效治療決策方面的臨床效用。

Turning to our biopharma business on slide 7. As I mentioned earlier, we had another record quarter of reported biopharma samples growing 40% year over year. Biopharma revenue grew 34% year-over-year in the third quarter. We continue to see a lot of excitement for GuardantINFINITY, our newest biopharma offering powered by our Smart Liquid Biopsy platform, driven by applications such as improved performance, novel biomarker discovery, and signature development. Smart Liquid Biopsy now represents over 50% of reported samples and new contracts.

轉向幻燈片 7 上我們的生物製藥業務。正如我之前提到的，我們報告的生物製藥樣本數量又創歷史新高，年增 40%。第三季生物製藥營收年增 34%。我們繼續看到 GuardantINFINITY 令人興奮，這是我們最新的生物製藥產品，由我們的智慧液體活檢平台提供支持，並受到性能改進、新型生物標誌物發現和特徵開發等應用的推動。智慧液體活檢目前佔已報告樣本和新合約的 50% 以上。

Importantly, this strength in biopharma is driven by our Smart Liquid Biopsy upgrade, and we are still in the early innings of this exciting upgrade cycle. We have recently seen an acceleration of our clinical Guardant360 LDT volume, demonstrating how biopharma R&D testing is an important leading indicator for demand of our clinical oncology tests and in turn, clinical patient testing is a driver for increasing biopharma interest. Taken together, these elements create an important virtuous cycle in the precision oncology space. Finally, we are also seeing increased momentum in China with a strong and growing pipeline of samples.

重要的是，生物製藥領域的這種優勢是由我們的智慧液體活檢升級所推動的，而我們仍處於這個令人興奮的升級週期的早期階段。我們最近看到我們的臨床 Guardant360 LDT 數量增加，這表明生物製藥研發測試是我們臨床腫瘤學測試需求的重要領先指標，反過來，臨床患者測試是增加生物製藥興趣的驅動力。總的來說，這些要素在精準腫瘤學領域創造了一個重要的良性循環。最後，我們也看到中國的勢頭增強，樣品管道不斷增加。

Now, shifting gears to Reveal on slide 8, where we are the leader in tissue-free MRD. Last quarter, we shared that data from our COSMOS colon study looking at Stage I and Stage II patients was published in the peer-reviewed journal Clinical Cancer Research. This study was also submitted to MolDX for Medicare reimbursement for the CRC surveillance MRD indication and review is ongoing. Beyond CRC surveillance, we have an extensive pipeline of clinical cohorts for establishing validity and utility for Guardant Reveal. This will be instrumental in building compelling evidence that, not only supports efforts to expand reimbursement, but also has potential to influence changes in practice guidelines. Looking ahead to the remainder of the year, we anticipate submissions for publications that will support potential Medicare reimbursement for coverage in breast cancer. Next year, we have important clinical validity studies for additional cancers such as lung, pancreatic, and gastric.

現在，轉向第 8 張投影片上的 Reveal，我們是無組織 MRD 領域的領導者。上個季度，我們分享了針對 I 期和 II 期患者的 COSMOS 結腸研究數據，該數據發表在同行評審期刊《臨床癌症研究》上。這項研究也提交給 MolDX，用於 CRC 監測 MRD 適應症的醫療保險報銷，並且正在進行審查。除了 CRC 監測之外，我們還擁有廣泛的臨床隊列來確定 Guardant Reveal 的有效性和實用性。這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。展望今年剩餘時間，我們預計將提交出版物，以支持潛在的乳癌醫療保險報銷。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。

Moving on to slide 9. We are excited by the demand we are seeing in the tissue-free MRD market, and there are multiple near-term inflection opportunities in 2025. We continue to make good progress towards CRC surveillance reimbursement, which will improve our ASP. We also remain on track on our COGS reduction initiatives for Reveal.

繼續看投影片 9。我們對無組織 MRD 市場的需求感到興奮，並且在 2025 年有多個近期拐點機會。我們在 CRC 監測報銷方面繼續取得良好進展，這將提高我們的平均售價。我們也持續致力於減少 Reveal 的銷貨成本計畫。

As a reminder, these two milestones will be a significant step towards our long-term goal of achieving greater than 60% gross margins for our MRD business. While we are seeing strong growth and strong market appetite for Reveal, we continue to manage volumes to minimize cash burn and we'll continue to do so until Reveal is gross margin positive, which we anticipate in 2025. Overall, we are seeing tremendous growth and opportunity around Guardant360, TissueNext, and Reveal largely driven by our recent Smart Liquid Biopsy platform transition. As a result of the great progress we have made this year and are continuing to make, we are more confident than ever that our oncology business will continue to see strong growth over the next few years.

提醒一下，這兩個里程碑將是我們實現 MRD 業務毛利率超過 60% 的長期目標的重要一步。雖然我們看到 Reveal 的強勁成長和強勁的市場需求，但我們將繼續管理銷售以最大程度地減少現金消耗，並且我們將繼續這樣做，直到 Reveal 的毛利率為正（我們預計在 2025 年）。總體而言，我們看到 Guardant360、TissueNext 和 Reveal 的巨大成長和機遇，很大程度上是由我們最近的智慧液體活檢平台轉型所推動的。由於我們今年取得了並將繼續取得的巨大進步，我們比以往任何時候都更有信心，我們的腫瘤業務將在未來幾年繼續強勁增長。

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

現在，我將把電話轉給阿米爾阿里，以了解篩檢的最新情況。

Thanks, Helmy. Moving on to slide 10. As we have previously announced, we are thrilled that FDA has approved our Shield blood test for colorectal cancer screening in adults ages 45 and older who are at average risk for the disease. Shield is the first blood test to be approved by FDA as a primary screening option for CRC and also the first blood test for CRC screening that is now covered by Medicare.

謝謝，赫爾米。繼續看投影片 10。正如我們之前宣布的，我們很高興 FDA 批准我們的 Shield 血液檢測用於 45 歲及以上患有該疾病平均風險的成年人的結直腸癌篩檢。Shield 是第一個獲得 FDA 批准作為 CRC 初級篩檢選項的血液檢測，也是目前由 Medicare 承保的第一個用於 CRC 篩檢的血液檢測。

Turning to slide 11. Just a few days after FDA approval, we brought Shield IVD to market with a successful launch in August. Our initial strategy is to focus on the covered patient population. This approach will help us to establish a strong foundation for industry-leading long-term scalability and profitability. I'm excited to share that we have had very positive reception and seen strong demand from physicians and patients in the first few months of the test being commercially available. To highlight this positive impact of Shield, I'd like to share an example of a primary care provider in rural, South Carolina, who had previously been facing challenges keeping patients up to date with colorectal screening guidelines.

轉到投影片 11。FDA 批准後幾天，我們將 Shield IVD 推向市場，並於 8 月成功上市。我們最初的策略是關注覆蓋的患者群體。這種方法將幫助我們為行業領先的長期可擴展性和盈利能力奠定堅實的基礎。我很高興地告訴大家，在該測試投入商業化的最初幾個月裡，我們得到了非常積極的反響，並看到了醫生和患者的強烈需求。為了強調 Shield 的正面影響，我想分享一個南卡羅來納州農村地區初級保健提供者的例子，該提供者之前一直面臨著讓患者了解最新結直腸篩檢指南的挑戰。

With the introduction of Shield blood test, he has seen his screening rates skyrocket. And in just the last few months alone, four of his patients received positive Shield test, quickly went through colonoscopy procedures and ultimately were diagnosed with early-stage colorectal cancer. In all four of these cases, the disease was cut early enough that these patients only required partial colectomy, avoiding any further treatment and most importantly, were able to quickly resume their lives.

隨著 Shield 血液檢測的推出，他的篩檢率激增。僅在過去的幾個月裡，他的四名患者就接受了 Shield 檢測呈陽性，並迅速進行了大腸鏡檢查，最終被診斷出患有早期大腸直腸癌。在所有這四個病例中，疾病得到了足夠早的切除，這些患者只需要部分結腸切除術，避免了任何進一步的治療，最重要的是，能夠迅速恢復生活。

Turning now to slide 12 to share some more exciting details on the launch reception. Early post-launch volume was ahead of our expectations, and we exited the quarter with strong momentum, which we continue to see in the fourth quarter.

現在轉到投影片 12，分享有關發布會的一些更令人興奮的細節。早期發布後的銷量超出了我們的預期，我們以強勁的勢頭結束了本季度，我們在第四季度繼續看到這種勢頭。

The majority of our volume is coming from covered patients. We saw robust depth of ordering by prescribing physicians. We continue to see an incredibly strong adherence rate of over 90%, which means over 90% of the patients completed the blood draw. And we are on track to have a trained sales force of over 100 people in the field by end of this year.

我們的大部分數量來自承保患者。我們看到處方醫生的處方深度很大。我們繼續看到超過 90% 的令人難以置信的高依從率，這意味著超過 90% 的患者完成了抽血。到今年年底，我們預計在該領域擁有一支超過 100 人的訓練有素的銷售團隊。

Moving on to slide 13. We are very pleased to report that Shield received a Medicare price of $920, recognizing Shield as an important new class of first-line CRC screening. This Medicare price makes us more confident that our ASP will be approximately $500 even prior to an advanced diagnostics laboratory test, or ADLT designation. We continue to expect to obtain ADLT designation and secure an even more favorable Medicare price of $1,495 in 2025.

繼續看投影片 13。我們非常高興地報告，Shield 獲得了 920 美元的醫療保險價格，承認 Shield 是重要的新第一線 CRC 篩檢。這個 Medicare 價格讓我們更有信心，即使在高級診斷實驗室測試或 ADLT 指定之前，我們的 ASP 也將約為 500 美元。我們繼續期望在 2025 年獲得 ADLT 指定並獲得更優惠的 Medicare 價格 1,495 美元。

Turning to slide 14. CMS has finalized the policy to remove cost sharing for a follow-on colonoscopy after blood-based screening test for Medicare beneficiaries. This ruling proactively removes barriers to blood-based CRC screening and acknowledges its unique benefits to promote access to cancer prevention and early detection, particularly for individuals within rural communities and communities of color that are especially impacted by the incidence of CRC. We are encouraged by the quick inclusion of blood in the final 2025 physician fee schedule. This rule will go into effect on January 1, 2025.

轉到投影片 14。CMS 已最終確定政策，取消對 Medicare 受益人進行血液篩檢測試後後續大腸鏡檢查的費用分攤。這項裁決積極消除了基於血液的結直腸癌篩檢的障礙，並承認其在促進癌症預防和早期檢測方面的獨特優勢，特別是對於特別受結直腸癌發病率影響的農村社區和有色人種社區中的個人。我們對血液快速納入 2025 年最終醫生費用表感到鼓舞。該規定將於2025年1月1日起施行。

Moving on to slide 15. We are proud of our team's execution throughout 2024, starting with publishing our pivotal study results in the New England Journal of Medicine, followed by positive advisory panel voting, receiving FDA approval with the first-line screening label, and finally, securing a favorable reimbursement rate and successful commercial launch.

繼續看投影片 15。我們對我們團隊在 2024 年的執行力感到自豪，首先在《新英格蘭醫學雜誌》上發表我們的關鍵研究結果，然後獲得顧問小組的積極投票，獲得 FDA 批准一線篩檢標籤，最後獲得有利的報銷率和成功的商業發布。

We look forward to executing our commercial scale-up and ramping adoption throughout the remainder of this year. We are excited about our upcoming milestones in 2025 and making Shield one of the most impactful products in the history of diagnostics. We are optimistic about the potential inclusion of Shield in American Cancer Society, or ACS guidelines, and expect to secure ADLT status, which enables improved ASP. We are pleased with the progress on indication expansion for Shield to become a leading multi-cancer detection blood test and expect to present our multi-cancer data. We are also planning to upgrade our CRC screening test with Shield V2.

我們期待在今年剩餘時間內擴大商業規模並提高採用率。我們對 2025 年即將到來的里程碑感到興奮，並使 Shield 成為診斷史上最具影響力的產品之一。我們對 Shield 可能納入美國癌症協會或 ACS 指南持樂觀態度，並期望獲得 ADLT 狀態，從而提高 ASP。我們對 Shield 的適應症擴展取得進展感到高興，成為領先的多種癌症檢測血液測試，並期望展示我們的多種癌症數據。我們也計劃使用 Shield V2 升級我們的 CRC 篩檢測試。

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. Turning to slide 16, I'll discuss our financial results for the three months ended September 30, 2024, and refer to year-over-year growth rates, unless otherwise noted. Total revenue grew 34% to $191.5 million, primarily driven by precision oncology revenue, which increased 35% to $180.6 million. precision oncology revenue from clinical tests increased 36% to $141.2 million. Clinical test volume grew to a record 53,100 tests in Q3 2024.

謝謝，阿米爾·阿里。轉向幻燈片 16，除非另有說明，我將討論截至 2024 年 9 月 30 日的三個月的財務業績，並參考同比增長率。總營收成長 34% 至 1.915 億美元，主要受到精準腫瘤學收入的推動，該收入成長 35% 至 1.806 億美元。來自臨床測試的精準腫瘤學收入成長了 36%，達到 1.412 億美元。2024 年第三季度，臨床測試量增加至創紀錄的 53,100 次測試。

Clinical volume growth of 21% was in line with our expectations and was primarily driven by Guardant360. As Helmy mentioned, we have seen very strong uptake of our upgraded Guardant360 LDT, which we launched in our Smart Liquid Biopsy platform at the start of Q3 and which led Guardant360 to grow sequentially in the mid-single digits. We also saw continued strong growth of Reveal and Tissue during the third quarter of 2024. For the full year 2024, despite the weather impacts we experienced at the end of Q3 and during October, we continue to expect total clinical volume growth to be approximately 20%.

21% 的臨床銷售成長符合我們的預期，主要是由 Guardant360 推動的。正如 Helmy 所提到的，我們看到升級後的 Guardant360 LDT 的使用非常強勁，該產品是我們在第三季初在智慧液體活檢平台上推出的，這導致 Guardant360 連續實現中個位數成長。我們也看到 Reveal 和 Tissue 在 2024 年第三季持續強勁成長。對於 2024 年全年，儘管我們在第三季末和 10 月經歷了天氣影響，但我們仍然預計總臨床量成長約為 20%。

Once again, our biopharma business performed incredibly well in the third quarter, with precision oncology revenue from biopharma tests totaling $39.4 million, increasing 34%. This exceptional growth was fueled by a record number of tests in the third quarter, 10,500, which was up 40%. With good line of sight to the end of the year, we now expect biopharma revenue growth to be in the high-20s for the full year 2024.

我們的生物製藥業務在第三季再次表現出色，來自生物製藥測試的精準腫瘤學收入總計 3,940 萬美元，成長了 34%。第三季測試數量達到創紀錄的 10,500 次，成長了 40%，推動了這一非凡的成長。鑑於到年底的良好前景，我們現在預計 2024 年全年生物製藥收入成長將在 20 左右。

Finally, development services and other revenue totaled $10.9 million. As a reminder, precision oncology clinical test volume does not include Shield tests, and we currently include Shield screening revenue in the development services and other line. We'll start to separately report Shield revenue and volume in the fourth quarter of 2024 as they become material to our numbers.

最後，開發服務和其他收入總計 1,090 萬美元。提醒一下，精準腫瘤學臨床測試量不包括 Shield 測試，我們目前將 Shield 篩檢收入納入開發服務和其他產品線。我們將在 2024 年第四季開始單獨報告 Shield 收入和銷售量，因為它們對我們的數據至關重要。

Turning to Guardant360 ASPs on slide 17. In the third quarter of 2024, we again saw very strong reimbursement and ASP trends for Guardant360. At our Investor Day in September 2023, we stated our goal was to reach an ASP of $3,000 for Guardant360 by 2028. Since our Investor Day, we've received an increase to our Guardant360 LDT Medicare rate from $3,500 to $5,000 and have seen significant improvements in both the amounts we've been paid for our tests and the speed at which we've been paid by commercial payers. As a result, we're very pleased to report that we achieved our long-term Guardant360 ASP goal of $3,000 in Q3 2024, roughly four years ahead of target.

轉向幻燈片 17 上的 Guardant360 ASP。2024 年第三季度，我們再次看到 Guardant360 的報銷和平均售價趨勢非常強勁。在 2023 年 9 月的投資者日上，我們表示我們的目標是到 2028 年 Guardant360 的平均售價達到 3,000 美元。自投資者日以來，我們的 Guardant360 LDT 醫療保險費率從 3,500 美元提高到 5,000 美元，並且我們的測試支付金額和商業支付速度都有顯著改善付款人。因此，我們非常高興地報告，我們在 2024 年第三季實現了 Guardant360 ASP 的長期目標 3,000 美元，比目標提前了大約四年。

Achieving this milestone so quickly is a testament to the strategic and operational excellence of our reimbursement team. In addition, the significant improvement in commercial reimbursement has led us to collect more cash than expected for our tests, which in turn has resulted in out-of-period revenue upside throughout the year. In Q3 2024, cash collected for Guardant360 tests performed in prior periods was $12 million above our expectations. It's worth noting that of this $12 million upside, more than half relates to tests performed in the first half of 2024, which illustrates how quickly and consistently we're now being reimbursed for our tests. Going forward, although we don't anticipate similar future out-of-period revenue upside, we believe our new Guardant360 ASP of $3,000 is sustainable and that we have the opportunity to further improve it over the next few years.

如此迅速地實現這一里程碑證明了我們報銷團隊的策略和營運卓越性。此外，商業報銷的顯著改善使我們在測試中獲得了比預期更多的現金，這反過來又導致了全年的期外收入上升。2024 年第三季度，為前期進行的 Guardant360 測試收取的現金比我們的預期高出 1,200 萬美元。值得注意的是，在這 1200 萬美元的上漲中，一半以上與 2024 年上半年進行的測試有關，這說明我們現在獲得測試報銷的速度有多快、有多一致。展望未來，儘管我們預計未來的期外收入不會出現類似的增長，但我們相信新的 Guardant360 3,000 美元的平均售價是可持續的，並且我們有機會在未來幾年進一步改進它。

Moving on to non-GAAP financial measures on slide 18. Our non-GAAP gross margin, excluding cost of screening, continues to be very strong and was 65% in the third quarter of 2024. Non-GAAP operating expenses were $187.3 million, an increase of $10 million compared to the prior year quarter. This was primarily driven by a planned increase in sales and marketing expense to support the commercial launch and expansion of Shield. The increase was partially offset by savings in R&D expense due to the reduction in ECLIPSE clinical trial spend, which completed enrollment towards the end of 2023.

接下來討論投影片 18 上的非 GAAP 財務指標。我們的非 GAAP 毛利率（不包括篩檢成本）仍然非常強勁，2024 年第三季為 65%。非 GAAP 營運費用為 1.873 億美元，比去年同期增加 1,000 萬美元。這主要是由於計劃增加銷售和行銷費用，以支持 Shield 的商業啟動和擴張。這一增長被 ECLIPSE 臨床試驗支出減少導致的研發費用節省部分抵消，該試驗於 2023 年底完成入組。

We continue to tightly control our operating expenses by leveraging the infrastructure we've built to support all of our businesses, by focusing our R&D spend on projects that will drive future growth and by directing our incremental investments towards the sales and marketing line to accelerate revenue across both screening and oncology. As a result of our increased revenue and operating leverage, both our adjusted EBITDA and free cash flow improved year-over-year in Q3 2024. Adjusted EBITDA loss was $56.2 million in Q3 2024, a decrease of $23.5 million from Q3 2023.

我們繼續嚴格控制我們的營運費用，利用我們為支持所有業務而建立的基礎設施，將我們的研發支出集中在將推動未來成長的項目上，並將我們的增量投資引導到銷售和行銷線以加速收入涵蓋篩檢和腫瘤學。由於我們收入和營運槓桿的增加，我們的調整後 EBITDA 和自由現金流在 2024 年第三季同比有所改善。2024 年第三季調整後 EBITDA 損失為 5,620 萬美元，比 2023 年第三季減少 2,350 萬美元。

Free cash flow for the third quarter of 2024 was negative $55.3 million, an improvement of $24.9 million from $80.2 million in Q3 2023. We ended the third quarter of 2024 with approximately $1 billion in cash, which we continue to believe is sufficient to enable us to achieve our goal of reaching cash flow breakeven by 2028. We also believe that achieving the Guardant360 ASP of $3,000, well ahead of our target of 2028, will reduce our total cash burn over the next few years and could help bring forward our cash flow breakeven target date.

2024 年第三季的自由現金流為負 5,530 萬美元，比 2023 年第三季的 8,020 萬美元增加了 2,490 萬美元。截至 2024 年第三季末，我們擁有約 10 億美元現金，我們仍然相信這足以使我們實現 2028 年實現現金流收支平衡的目標。我們也相信，實現 Guardant360 平均售價為 3,000 美元，遠遠超出我們 2028 年的目標，將減少未來幾年的總現金消耗，並有助於提前實現現金流收支平衡的目標日期。

Now, turning to our outlook and assumptions for the full year 2024 on slide 19. We are pleased to be able to increase our revenue guidance for the third time this year and now expect full year 2024 revenue to be in the range of $720 million to $725 million, representing growth of approximately 28% to 29% compared to 2023. This compares to our initial revenue guidance of 16% to 19% that we provided in February of this year. This latest increase reflects the further improvement in Guardant360 ASPs, the cash collection upside we had in the third quarter, our higher expectation for full year biopharma revenue and revenue contribution from Shield.

現在，轉向幻燈片 19 上我們對 2024 年全年的展望和假設。我們很高興能夠今年第三次提高我們的收入指導，現在預計 2024 年全年收入將在 7.2 億至 7.25 億美元之間，與 2023 年相比增長約 28% 至 29%。相較之下，我們今年 2 月提供的初始收入指引為 16% 至 19%。這一最新成長反映了 Guardant360 ASP 的進一步改善、我們在第三季的現金回收優勢、我們對全年生物製藥收入和 Shield 收入貢獻的更高預期。

We continue to expect non-GAAP gross margin, excluding screening, to be in the range of 61% to 63% and non-GAAP operating expenses to be in the range of $720 million to $730 million, representing a flat to 1% decline year over year. In addition, we now expect free cash flow for 2024 to be in the range of negative $265 million to $275 million, an improvement of $70 million to $80 million compared to 2023 and an improvement compared to our prior expectations of negative $275 million to $285 million. We continue to expect that our therapy selection business will deliver positive free cash flow for the full year 2024 and screening cash burn this year will be approximately $175 million. Finally, while we typically reserve granular out-year commentary to our Q4 earnings in February, we would like to share some initial considerations as you think about next year.

我們繼續預期非 GAAP 毛利率（不包括放映）將在 61% 至 63% 之間，非 GAAP 營運費用將在 7.2 億美元至 7.3 億美元之間，年減 1%。此外，我們現在預計2024 年的自由現金流將在負2.65 億美元至2.75 億美元之間，比2023 年改善7,000 萬美元至8,000 萬美元，也比我們先前預期的負2.75 億美元至2.85 億美元有所改善。我們仍然預計，我們的治療選擇業務將在 2024 年全年帶來正的自由現金流，今年的篩選現金消耗將約為 1.75 億美元。最後，雖然我們通常會對 2 月的第四季度收益保留詳細的年度評論，但我們希望與您分享一些您對明年的初步考慮。

With the positive traction we're seeing from our launch of Guardant360 LDT on Smart Liquid Biopsy, we expect an acceleration in Guardant360 volume growth in 2025. As a result of this and continued expected strong growth across both Reveal and TissueNext, we expect oncology clinical volume growth to accelerate above 20% in 2025, even without including contributions from Shield, which we will report separately.

鑑於我們在智慧液體活檢上推出 Guardant360 LDT 所帶來的積極推動力，我們預計 Guardant360 銷量將在 2025 年加速成長。由於這一點以及 Reveal 和 TissueNext 的預期持續強勁增長，我們預計 2025 年腫瘤學臨床量增長將加速超過 20%，即使不包括 Shield 的貢獻（我們將單獨報告）。

Finally, turning to slide 20 to review our catalysts. We've made significant progress on milestones across each of our business areas this year. As we look ahead to the rest of 2024, we are very excited by the potential opportunities across therapy selection, MRD, and screening.

最後，轉向幻燈片 20 回顧我們的催化劑。今年，我們在每個業務領域的里程碑上都取得了重大進展。展望 2024 年剩餘時間，我們對治療選擇、MRD 和篩檢的潛在機會感到非常興奮。

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

現在，我們將開始提問。

(Operator Instructions) Bill Bonello, Craig-Hallum.

（操作員說明）Bill Bonello，Craig-Hallum。

Congratulations on a great quarter, guys. Question on the Shield plans, sort of two parts on it. One, with the initial Medicare pricing even before ADLT looking pretty strong, I'm curious if that makes you think differently at all about how aggressive you might be sort of early on in terms of your sales and marketing efforts.

夥計們，恭喜你們度過了一個出色的季度。關於盾牌計劃的問題，分為兩部分。第一，即使在 ADLT 之前，最初的醫療保險定價看起來也相當強勁，我很好奇這是否會讓您以不同的方式思考您在銷售和行銷工作的早期可能有多積極。

And then the second part of that is just conventional wisdom is obviously that you need USPSTF recommendations to secure commercial reimbursement. I'm just curious if -- to what degree you think that's the case universally. Or if you've had conversations at all where people with payers where you think you might actually be able to secure reimbursement even without that?

第二部分顯然是傳統觀點，即您需要 USPSTF 的建議來確保商業報銷。我只是好奇你認為這種情況在多大程度上是普遍存在的。或者，如果您與付款人進行對話，您認為即使沒有付款，您實際上也可能能夠獲得報銷？

Thanks, Bill, for the question. So I want to reiterate our commitment that we made that we -- under all kind of scenarios, the level of investments that we are going to have for Shield in terms of the spend would be around that maximum $200 million for the following years. And this year, $175 million as you see that in our reiterated guidance. And even that level of investment is assuming we are going to meet the milestones, the business milestones that we are going to have. I'm very pleased about 2024 and many milestones that we have achieved, but we are still in the early innings, very, very early innings of commercialization.

謝謝比爾提出這個問題。因此，我想重申我們的承諾，在各種情況下，我們對 Shield 的投資水準在接下來的幾年中的支出將在最高 2 億美元左右。正如您在我們重申的指導中看到的那樣，今年為 1.75 億美元。即使是這樣的投資水準也是假設我們將達到里程碑，也就是我們將要達到的業務里程碑。我對 2024 年以及我們實現的許多里程碑感到非常高興，但我們仍處於商業化的早期階段，非常非常早期的階段。

We need to continue to monitor our volume ramp and meeting revenue milestones that we have to continue that level of investment. But, obviously, I'm very pleased with this Medicare pricing that we got. It gives us a lot of opportunity. When you think about now our ASP is approximately $500, effectively even before ADLT, we can get to a reasonable actually gross margin for this test very soon as the volume start to scale as we go to 2025. So we are very, very pleased with where we are sitting. But it doesn't mean that these positive developments is going to change our financial discipline of the level of investment.

我們需要繼續監控我們的銷售成長並達到收入里程碑，我們必須繼續這一水平的投資。但是，顯然，我對我們得到的醫療保險定價非常滿意。它給了我們很多機會。現在想想，我們的 ASP 約為 500 美元，甚至在 ADLT 之前就有效，隨著到 2025 年銷量開始擴大，我們很快就能為該測試獲得合理的實際毛利率。所以我們對我們所處的位置非常非常滿意。但這並不意味著這些積極的發展將改變我們投資水平的財務紀律。

In terms of USPSTF, yes, we continue to look at USPSTF as a major milestone for us that would enable a lot of commercial accessibility for the patient on the younger side, 45 to 64. Having said that, this segment of the market, which is now covered today is very deep. We have a lot of business to mind while we are waiting for guideline inclusion and USPSTF. There is a very -- this is a very deep market.

就 USPSTF 而言，是的，我們繼續將 USPSTF 視為我們的一個重要里程碑，它將為 45 歲至 64 歲的年輕患者提供大量商業機會。話雖如此，今天所涉及的這一部分市場是非常深入的。在等待指南納入和 USPSTF 期間，我們有許多事務需要處理。這是一個非常——這是一個非常有深度的市場。

So it's not that we are going to be just waiting for that guideline. There's a lot of business to mind here, especially now that we have -- we are going to have a healthy gross margin in near future. And also keep in mind, there is American Cancer Society guidelines and some of the impact that, that guideline inclusion could have on select state-based on state-level mandates that they have.

因此，我們並不是要等待該指導方針。這裡有很多業務需要關注，特別是現在我們——我們將在不久的將來擁有健康的毛利率。另請記住，有美國癌症協會指南，以及該指南的納入可能會對基於州級授權的特定州產生一些影響。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, guys. Thanks for the question. Congrats on the quarter. I think some of us were hoping to perhaps hear how Shield is doing in the field. I think most people thought somewhere in the low- to mid-thousands of tests. I know -- I think I heard you say you plan to report that out next quarter. But maybe, AmirAli, can you just give us a sense, any metrics like ordering providers or just feedback that you're hearing in the field? I think that would be helpful.

嘿，夥計們。謝謝你的提問。恭喜本季。我想我們中的一些人可能希望聽到盾牌在該領域的表現。我認為大多數人都認為進行了數千次測試。我知道——我想我聽到你說你計劃在下個季度報告這一點。但也許，AmirAli，你能給我們一個感覺，任何指標，例如訂購提供商，或者只是你在現場聽到的反饋？我認為這會有幫助。

And then a question for Mike about the Shield target for $500 million plus by 2028 on 1 million tests, this is at your Analyst Day, assumed a price of $500 plus. Your Medicare price is already set at $920 and may go up to $1,500. So just making sure you guys likely see some upside to that initial target that you provided at the Analyst Day.

然後麥克問了一個關於 Shield 目標的問題，即到 2028 年進行 100 萬次測試，目標是 5 億美元以上，這是在分析師日，假設價格為 500 美元以上。您的 Medicare 價格已定為 920 美元，可能會上漲至 1,500 美元。因此，請確保您可能會看到您在分析師日提供的初始目標的一些好處。

Yeah, sure, Mark. Thanks for good question. So we are not breaking out like Shield volume at this time, but I can tell you, we are very pleased with the progress. The initial volume post-launch is ahead of our expectation. We are now three months into it.

是的，當然，馬克。謝謝你的好問題。所以我們目前還沒有像盾牌卷那樣爆發，但我可以告訴你，我們對進展感到非常滿意。發布後的初始銷量超出了我們的預期。我們現在已經三個月了。

We had a good couple of months last quarter, exited last quarter with good momentum, and that momentum continues to build in this quarter for us. We had a good October, but still 3Q was not a full quarter for us. So it's too early to break it out. But based on the traction that we are seeing, we do fully intend to report the volume and revenue contribution of Shield in our Q4 numbers and Q4 call. So looking forward to sharing more details at the time.

上個季度我們度過了愉快的幾個月，上個季度結束時勢頭良好，並且這種勢頭在本季度繼續增強。我們度過了一個美好的十月，但第三季對我們來說仍然不是一個完整的季度。所以現在斷言還為時過早。但根據我們所看到的吸引力，我們確實打算在第四季度的數據和第四季度的電話會議中報告 Shield 的銷售和收入貢獻。因此期待屆時分享更多細節。

The market feedback, as we expected actually, has been very positive. The target primary care physicians that we are going after are very enthusiastic about adding this option for patients and giving them the choice, as I mentioned in the prepared remarks, like the depth of ordering is very healthy for us for this blood test, which frankly is just an endorsement of how deep this market is more than our commercial execution. I'm proud of what we've done, but the reality is, this market of unscreened patient population and the people who are ready for rescreening is a very, very deep market. So we are seeing actually -- we are seeing very strong depth of ordering at this time, too. I'm looking forward to sharing more details in our Q4 results.

正如我們實際預期的那樣，市場反饋非常積極。我們要尋找的目標初級保健醫生非常熱衷於為患者添加此選項並給予他們選擇，正如我在準備好的評論中提到的那樣，就像訂購的深度對我們進行血液測試非常健康，坦率地說只是對這個市場深度的認可，而不僅僅是我們的商業執行力。我為我們所做的事情感到自豪，但現實是，這個由未經篩檢的患者群體和準備重新篩檢的人組成的市場是一個非常非常深入的市場。所以我們實際上看到——我們此時也看到了非常強大的訂購深度。我期待在第四季的業績中分享更多細節。

Yeah. And Mark, on your comments on our Investor Day target, yeah, we set the target in 2028 to be -- to have Shield revenue of $500 million with 1 million tests. And so, yeah, implying an ASP of $500. I think since our Investor Day, quite a few things have gone positively for us versus the assumptions we had. I mean, firstly, I think the ASP, getting this Medicare rate of $920, now we already have ASPs around the $500 mark.

是的。馬克，關於您對我們投資者日目標的評論，是的，我們在 2028 年設定的目標是——透過 100 萬次測試讓 Shield 收入達到 5 億美元。所以，是的，這意味著平均售價為 500 美元。我認為自投資者日以來，與我們的假設相比，很多事情都朝著正面的方向發展。我的意思是，首先，我認為 ASP 的醫療保險費率為 920 美元，現在我們的 ASP 已經在 500 美元左右。

When we get the ADLT rate, then it's going to depend on the payer mix. But I think we're confident that we can increase that ASP above $500. So that's one thing. I think the other two assumptions that we had at that Investor Day was, one that, we were assuming something more akin to a second-line label. And, of course, that's gone in our favor now, and we have a first-line label.

當我們獲得 ADLT 費率時，它將取決於付款人組合。但我認為我們有信心將 ASP 提高到 500 美元以上。所以這是一回事。我認為我們在投資者日的另外兩個假設是，我們假設的東西更類似於二線品牌。當然，現在這對我們有利，我們有了一線品牌。

And then secondly, we assumed that competition would be on the market about approximately a year after we launched. And I think now we look at where potential competition is, it's probably at least 2.5 years to be on the market after our launch back in August. So I think things are going very well for us. We don't want to sit here today and give out some new long-term guidance, but I think that $500 million and 1 million tests, we're feeling very confident about.

其次，我們假設市場上將在我們推出後大約一年內出現競爭。我認為現在我們看看潛在的競爭在哪裡，自 8 月推出以來，可能需要至少 2.5 年的時間才能上市。所以我認為我們一切進展順利。我們今天不想坐在這裡給出一些新的長期指導，但我認為我們對 5 億美元和 100 萬次測試感到非常有信心。

Subbu Nambi, Guggenheim.

蘇布南比，古根漢。

Hey, guys. Thank you for taking my question. Our recent KOL checks indicate that therapy selection TAM may be larger than what we previously anticipated even during your IPO, the 700,000 late-stage metastatic solid tumor patients for a test like Guardant360. And given repeat testing opportunity, could you comment on what you see as the TAM in maybe the number of tests for Guardant360 and with respect to repeat ordering for the same patient?

嘿，夥計們。謝謝你回答我的問題。我們最近的 KOL 檢查表明，即使在 IPO 期間，治療選擇 TAM 也可能比我們之前預期的要大，即對 700,000 名晚期轉移性實體瘤患者進行像 Guardant360 這樣的測試。如果有重複測試的機會，您能否評論一下您認為 TAM 在 Guardant360 的測試數量以及對同一患者的重複訂購方面的情況？

Yeah. No, thank you for the question. It's something that I think we outlined in great depth at our Investor Day last year is essentially that right now, the market in therapy selection has been focused on what we call zero to one, just getting patients to one test per patient for a lifetime. And you see that now there are first-line, second-line, third-line therapies. There are -- there needs to be adaptive management of patients as their therapies stop working and they get cycled to a new therapy.

是的。不，謝謝你的提問。我認為我們在去年的投資者日上深入概述了這一點，本質上是目前治療選擇市場一直專注於我們所說的“零到一”，即讓患者一生接受一次測試。你看現在有一線、二線、三線療法。當患者的治療停止起作用並開始接受新的治療時，需要對患者進行適應性管理。

And so, yes, we see the market growing by orders of magnitude. We can see a future where patients are getting three, four, five therapy selection tests over their lifetime, which obviously grows the market considerably. And that's what -- that's why I think we're very excited about the future that is before us. We're seeing with our biopharma partners that they're testing their patients' multiple times or testing samples multiple times for some of these new drugs. And just like we've seen, we saw record biopharma volume over the last few quarters in a space where people were struggling with biopharma.

因此，是的，我們看到市場呈現數量級增長。我們可以預見，未來患者將在一生中接受三、四、五次治療選擇測試，這顯然將大大增加市場。這就是為什麼我認為我們對擺在我們面前的未來感到非常興奮。我們與我們的生物製藥合作夥伴一起看到，他們正在對患者進行多次測試，或者對其中一些新藥的樣本進行多次測試。就像我們所看到的那樣，在過去幾個季度，我們看到了創紀錄的生物製藥銷量，而人們卻在生物製藥領域苦苦掙扎。

We are an outlier there. And now that's translating to the clinical side. And I think you're going to see that further translate to further momentum in clinical testing. So, yeah, we see this as a really important growth driver that, frankly, only liquid biopsy can really hit because you can't take tissue biopsies multiple times from patients in an easy way. And this is really where having what we consider to be the best performing and I think really sort of most complete liquid biopsy in the market with our new upgraded panel puts us in full position to capture that market.

我們是那裡的局外人。現在這正在轉化為臨床方面。我認為你會看到這進一步轉化為臨床測試的進一步動力。所以，是的，我們認為這是一個非常重要的成長動力，坦白說，只有液體活檢才能真正發揮作用，因為你無法以簡單的方式多次從患者身上進行組織活檢。這確實是我們認為性能最佳的地方，我認為市場上最完整的液體活檢和我們新升級的面板使我們完全有能力佔領該市場。

Tycho Peterson, Jefferies.

第谷·彼得森，杰弗里斯。

Hey, thanks. On the back of COSMOS, I'm just wondering if you can help us size potential upside from Reveal surveillance coverage next year. I know you talked at September conferences of about 12 million or 15 million potential patients being cancer survivors. But what could it do next year? Any more framework you can put around ASP? You obviously have talked about the $2,000 ASP when you're paid by Medicare, but how do we think about ASPs next year?

嘿，謝謝。在 COSMOS 的支持下，我只是想知道您是否可以幫助我們評估明年 Reveal 監控覆蓋範圍的潛在優勢。我知道您在 9 月的會議上談到了大約 1200 萬或 1500 萬潛在患者是癌症倖存者。但明年它能做什麼呢？您還可以在 ASP 周圍添加更多框架嗎？您顯然已經談到了 Medicare 支付時的 ASP 為 2,000 美元，但我們如何看待明年的 ASP？

And then did you give a G360 number? I know last quarter it was $2,500. Can you give us the number there? And are you reiterating your 20% target for the year?

然後你給了G360號碼嗎？我知道上個季度是 2,500 美元。你能給我們那裡的電話號碼嗎？您是否重申今年 20% 的目標？

Yeah. I mean, I can maybe take the 20% target for next year, Tycho. So one, we -- yes, we reiterated just on the call then that 20% clinical volume growth, we still expect that for this year. And we've seen an acceleration in Guardant360 volume growth, particularly driven by the LDT. And so, as we go into 2025, we talked about volume acceleration with Guardant360, but then also we're seeing good traction with TissueNext and Reveal as well.

是的。我的意思是，我也許可以實現明年 20% 的目標，第谷。因此，我們——是的，我們在電話會議上重申了 20% 的臨床數量成長，我們仍然預計今年會實現這一目標。我們已經看到 Guardant360 銷量的加速成長，尤其是在 LDT 的推動下。因此，當我們進入 2025 年時，我們討論了 Guardant360 的銷量加速，但我們也看到了 TissueNext 和 Reveal 的良好吸引力。

And driving Reveal acceleration, and we've said this many times, is going to be focused or driven by the fact that we get additional reimbursements on the CRC surveillance side and that we bring that cost per test down. So we move Reveal from being a negative gross margin to a positive gross margin. So we're making good traction on all of those things. And so, as we go into 2025, assuming we get the CRC surveillance reimbursement from MolDX, I think we'll have an uptick to our ASP. It's a bit difficult to quantify that uptick yet.

我們已經多次說過，推動 Reveal 加速的重點或驅動因素是我們在 CRC 監測方面獲得額外報銷，我們降低了每次測試的成本。因此，我們將 Reveal 從負毛利率調整為正毛利率。因此，我們在所有這些事情上都取得了良好的進展。因此，當我們進入 2025 年時，假設我們從 MolDX 獲得 CRC 監測報銷，我認為我們的 ASP 將會上升。目前還很難量化這種上升趨勢。

It's going to depend on the reimbursement rate that we get from Medicare. But yeah, we'll have an uptick in the volume. And again, with gross margins being positive, it's going to allow us to put the foot on the accelerator and push Reveal to significantly accelerate next year.

這將取決於我們從醫療保險中獲得的報銷率。但是，是的，我們的銷量將會增加。再說一次，由於毛利率為正，這將使我們能夠踩下加速器，推動 Reveal 明年大幅加速。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Yeah. Hi, AmirAli, Helmy. Thanks for taking my question, and Mike. It's great to see the Medicare at $920 for Shield, and it will be material in fourth quarter. I mean, a bigger question here is that you're ahead of any other liquid biopsy CRC screening test in the market. A competitor could potentially emerge in 2026, but I think you're going to have V2 data before that. So could you please provide a timing on that V2 data? And also, what is your assumption of market penetration for Shield CRC now since having this in the market since in August? Thank you.

是的。嗨，阿米爾阿里，赫爾米。感謝您提出我的問題，還有麥克。很高興看到 Shield 的 Medicare 價格為 920 美元，這將在第四季度發揮重要作用。我的意思是，這裡一個更大的問題是，您領先於市場上任何其他液體活檢 CRC 篩檢測試。競爭對手可能會在 2026 年出現，但我認為在此之前您將會獲得 V2 數據。那麼您能提供一下 V2 資料的時間嗎？另外，自從 8 月 Shield CRC 進入市場以來，您對 Shield CRC 的市場滲透率有何假設？謝謝。

Yeah. Thanks, Puneet. So in terms of Shield V2, we continue to expect having that data and if data is positive, potentially upgrade our Shield so that V2 in 2025. So we are making progress there. In terms of market share today, our blood test, we are just two months into it, so we don't have really any material market share in terms of CRC screening yet.

是的。謝謝，普尼特。因此，就 Shield V2 而言，我們繼續期望獲得該數據，如果數據是積極的，則可能會升級我們的 Shield，以便在 2025 年升級到 V2。所以我們正在那裡取得進展。就今天的市場份額而言，我們的血液檢查剛剛開展兩個月，所以我們在結直腸癌篩檢方面還沒有真正的實質市場份額。

In terms of our kind of long-term projection, what we shared in last fall in the Investor Day that assumption in that 1 million, at the time, we assume we are going to have 60% market share in blood-based CRC screening at the time. And as Mike mentioned earlier, we assume there would be more progress by some of our competition than what we have observed. So -- but we'll see how the market would shape out. We don't expect to see any other competing tests to get FDA approval and Medicare reimbursement for at least the next two years, or 2.5 years. So (inaudible).

就我們的長期預測而言，我們在去年秋天的投資者日分享了這一假設，當時我們假設我們將在基於血液的 CRC 篩檢領域佔據 60% 的市場份額。正如麥克之前提到的，我們認為我們的一些競爭對手會取得比我們觀察到的更多的進步。所以——但我們會看看市場將如何發展。我們預計至少在未來兩年（即 2.5 年）內不會看到任何其他競爭測試獲得 FDA 批准和醫療保險報銷。所以（聽不清楚）。

Kyle Mikson, Canaccord.

凱爾米克森，Canaccord。

Hey, thanks for taking the question. Congrats on the quarter. For Mike, the growth implied by the updated guidance is 20% to 29% over '23. That compares to 16% to 19% in the initial guide for '24. How much of that 11 percentage point delta in growth has been from these like prior period collections and the Medicare pricing updates for G360? Like essentially, what's the core revenue growth?

嘿，謝謝你提出問題。恭喜本季。對 Mike 來說，更新後的指導意味著 23 年成長了 20% 到 29%。相比之下，24 年初始指南中的比例為 16% 至 19%。這 11 個百分點的成長增量中有多少來自前期收款和 G360 的 Medicare 定價更新等？從本質上講，核心收入成長是多少？

And quickly for AmirAli, Shield has been available as an LDT since May of 2022. How many of those early patients have retaken the test? What are those reordering rates looking like so far? What are your expectations? Thanks.

對 AmirAli 來說，Shield 自 2022 年 5 月起已作為 LDT 提供。有多少早期患者重新接受了測試？到目前為止，重新訂購率是多少？您的期望是什麼？謝謝。

Yeah, Kyle, from the sort of prior period cash upsides that we've had, we reported $8 million in Q1 and then $8 million in Q2 and then $12 million. So $28 million in total. But of that $28 million, $8 million of that is within 2024, so coming from Q1 and Q2. So effectively, from these out-of-period upside, it's roughly around $20 million. So the other, obviously, drivers of growth have been on the clinical volume side.

是的，凱爾，從我們之前的現金成長來看，我們第一季報告了 800 萬美元，第二季報告了 800 萬美元，然後是 1200 萬美元。總共 2800 萬美元。但在這 2800 萬美元中，其中 800 萬美元是在 2024 年完成的，因此來自第一季和第二季。因此，從這些期外上漲來看，實際上大約是 2,000 萬美元左右。因此，顯然，另一個成長驅動因素是臨床數量方面。

Primarily, that's Guardant360 volume growth. It's been increased to the Guardant360 ASP. We reiterated again that, that's now at $3,000 and then, of course, the incredible performance that we've seen in the biopharma business. So, growth drivers really across all of the business on top of the additional sort of $20 million that we've got from prior year upsides.

主要是 Guardant360 銷量的成長。它已增加到 Guardant360 ASP。我們再次重申，現在價格為 3,000 美元，當然，還有我們在生物製藥業務中看到的令人難以置信的業績。因此，除了我們從去年的成長中獲得的 2000 萬美元額外收入之外，整個業務的成長確實是一個驅動力。

Regarding reordering rate, Kyle, like as you mentioned, we launched the LDT in May of '22. So -- and our recommended interval is every three years. So we haven't reached that time window for -- to see what fraction of those patients would get retested. That would be probably something towards like later part of next year that maybe we can have some data.

關於重新訂購率，Kyle，正如您所提到的，我們在 22 年 5 月推出了 LDT。因此，我們建議的間隔是每三年一次。所以我們還沒有達到那個時間窗口——看看這些患者中有多少比例會重新測試。這可能會在明年下半年，也許我們可以獲得一些數據。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hey guys, good evening. Maybe I'll start with one on G360 and then one on screening. So, Mike, one for you on that sort of growth rate in clinical volume next year exceeding 20%. You've got the Smart LB upgrade. You've got the ESR1 dynamic now sort of squarely behind you. You called out a little bit of weather impact as well weighing down recent volume, and you've got the surveillance reimbursement for Reveal coming through, which should help volume in the back half of next year, right?

嘿夥計們，晚上好。也許我會先從 G360 開始，然後再從放映開始。那麼，Mike，請為您介紹明年臨床數量的成長率將超過 20%。您已獲得智慧負載平衡升級。現在，ESR1 動態已經完全在您身後了。你指出天氣的影響也影響了最近的交易量，而且你已經獲得了 Reveal 的監控補償，這應該有助於明年下半年的交易量，對嗎？

So any sort of finer point you can put on how much the quantum of the acceleration versus that 20% floor for next year? And then on the Shield side of things, AmirAli, can you share some lessons on what you've learned in terms of the initial lab setup and the ordering process for these new accounts that have come on board post August? And have you had any sort of pushback from health systems, et cetera, around quality scores? Just trying to get a sense for what that could mean for the Shield volume ramp into '25 as we try and benchmark it versus the early days of stool-based testing.

那麼，對於明年的 20% 下限，您能提出多少加速量呢？然後，在 Shield 方面，AmirAli，您能否分享一些您在初始實驗室設置和 8 月後加入的新帳戶的訂購流程方面學到的經驗教訓？在品質分數方面，您是否受到衛生系統等方面的任何阻力？只是想了解這對 Shield 銷售量增加到 25 年意味著什麼，因為我們嘗試將其與早期基於糞便的測試進行基準測試。

Yes, I'll take the first one on the volumes, Tejas. Yeah, I think you laid out what we've seen in 2024 with the difficult ESR 1 comps with weather impacts, but we're still on track to be approximately 20% growth this year. And yeah, we're very, very confident that, that clinical volume growth will accelerate in 2025 above 20%. And again, I laid out in the prepared remarks, but that's going to be driven by growth across all the products on the oncology side. So, yeah, Guardant360, again, we're seeing really good traction with the LDT and the Smart Liquid Biopsy upgrade.

是的，我會選擇磁碟區上的第一個，Tejas。是的，我認為您列出了我們在 2024 年所看到的情況，即困難的 ESR 1 比較與天氣影響，但今年我們仍有望實現約 20% 的增長。是的，我們非常非常有信心，到 2025 年，臨床數量成長將加速超過 20%。我在準備好的發言中再次指出，但這將由腫瘤學方面所有產品的成長所推動。所以，是的，Guardant360，我們再次看到 LDT 和智慧液體活檢升級的良好吸引力。

So we know that, that volume is going to accelerate going into 2025. Again, TissueNext, we had an upgraded product launch just recently, and we've seen nice traction there. And so, that growth is accelerating. And again, you laid out the upside that we can have on Reveal once we can start to accelerate the volumes and -- at some point in 2025. So I think we don't want to be more specific than accelerating above 20%. But I think we sit here very confident across all the products on the oncology side of the business.

所以我們知道，到 2025 年，這一數量將會加速成長。再說一次，TissueNext，我們最近剛推出了升級產品，並且我們在那裡看到了很好的吸引力。因此，這種成長正在加速。您再次闡述了一旦我們能夠開始加速銷量，並且在 2025 年的某個時候，我們可以在 Reveal 上獲得的好處。所以我認為我們不想比加速超過 20% 更具體。但我認為我們對腫瘤學的所有產品都非常有信心。

Starting with Shield work front experience since August 1, definitely just being in market, the LDT those kind of experimentation and getting feedback from market, we really incorporated a lot of those learnings in this successful launch in terms of digital solutions that we have workflows that we have connection to blood draw services that we have, even on EMR integration, still, it's very, very early days. But about 15% of our orders even these days are coming from the accounts that we have full EMR integration. We are in very early innings of it, but I'm very pleased with this strong foundation that we built to support the strong launch. In terms of quality score, that's very relevant. That's very relevant parameter.

從8 月1 日以來的Shield 工作前端經驗開始，絕對只是進入市場，LDT 進行了此類實驗並從市場獲得反饋，我們在這次成功推出的數位解決方案中確實融入了許多這些經驗教訓，我們擁有的工作流程我們與現有的抽血服務有聯繫，即使在 EMR 整合方面，仍然處於非常非常早期的階段。但即使是現在，我們仍有約 15% 的訂單來自我們完全 EMR 整合的帳戶。我們正處於早期階段，但我對我們為支持強勁發布而建立的堅實基礎感到非常滿意。就品質分數而言，這是非常相關的。這是非常相關的參數。

As part of our targeting, we are kind of not going a lot after the health system accounts or the ones that have higher sensitivity around quality score. We continue to believe actually Shield testing has potential to even improve quality score without inclusion of blood-based CRC screening as a modality based on the fact that unscreened patients come around the table and then a fraction of them go through colonoscopy after getting the blood data. But we are kind of not targeting those accounts which have high sensitivity toward quality metrics until we get to the guidelines and either scores gets adjusted. But that's a very material parameter in terms of the adoption of this test over time.

作為我們目標的一部分，我們不會過度關注衛生系統帳戶或對品質評分敏感度較高的帳戶。我們仍然相信，事實上，Shield 測試甚至有可能在不將基於血液的CRC 篩檢作為一種方式的情況下提高品質評分，因為未經篩檢的患者會來到手術台旁，然後其中一小部分人在取得血液數據後會接受大腸鏡檢查。但在我們達到指導方針並且對任何一個分數進行調整之前，我們不會針對那些對品質指標高度敏感的帳戶。但就隨著時間的推移採用該測試而言，這是一個非常重要的參數。

Dan Brennan, TD Cowen.

丹布倫南，TD·考恩。

Great, thank you. Thanks for the questions. Maybe I'll just ask on Reveal. Could you provide any color on the contribution in the quarter and kind of what's assumed in 4Q? For COSMOS, I think you submitted maybe three or so months ago. Could you give any color on how the process is going, kind of when you expect to hear back?

太好了，謝謝。感謝您的提問。也許我會在 Reveal 上詢問。您能否提供有關本季度貢獻的任何資訊以及第四季度的假設？對於 COSMOS，我想你大概是在三個月左右之前提交的。您能否透露一下整個過程的進展情況，以及您希望何時收到回覆？

And then I know you put in the slide, the breast publication, I think, is expected before year end. Could you just provide some more color in terms of the indication? And what would that portend for MolDX filing? Thanks.

然後我知道你在幻燈片中放入了乳房出版物，我認為預計將在年底前發布。您能否在指示方面提供更多顏色？這對 MolDX 備案來說意味著什麼？謝謝。

I'll take the second half and let Mike take the first. Yeah, in terms of the process around the reimbursement for the CRC surveillance indication, we're making good progress. There has been a couple of back and forth some clarification of data, but -- and we're still hopeful that sometime early next year, we should be able to get over the finish line.

我將負責下半場，讓麥克負責上半場。是的，就 CRC 監測指標的報銷流程而言，我們正在取得良好進展。我們對數據進行了一些反覆的澄清，但是——我們仍然希望明年初的某個時候，我們應該能夠衝過終點線。

We've made good progress with the breast data. We expect to submit that soon for publication. And then it will depend on how fast it sort of comes out and gets accepted by the relevant journal. But yeah, we think next year should be a very important year for us in terms of getting really the two largest indications in MRD, breast and CRC under our belts. And then, obviously, that, coupled with the major COGS reduction initiatives that we have should put us in good shape.

我們在乳房數據方面取得了良好進展。我們希望盡快提交發布。然後這將取決於它的發表和被相關期刊接受的速度。但是，是的，我們認為明年對我們來說應該是非常重要的一年，因為我們真正掌握了 MRD 的兩個最大的適應症，即乳癌和 CRC。顯然，再加上我們採取的重大銷售成本削減舉措，應該會讓我們處於良好的狀態。

Yeah. Maybe on the Reveal, Dan, we're not breaking out the volumes or the revenue contribution for Reveal. I can tell you that of the sequential growth, the biggest driver of that sequential growth and the majority of the sequential growth was from Guardant360. But coming to second place was Reveal. So it's still growing very nicely, even though we're managing those volumes.

是的。也許在 Reveal 上，丹，我們不會透露 Reveal 的銷售或營收貢獻。我可以告訴您，在環比增長中，環比增長的最大驅動力以及環比增長的大部分來自 Guardant360。但排在第二位的是Reveal。因此，儘管我們正在管理這些數量，但它仍然成長得非常好。

And so, we saw nice year-over-year growth from Reveal and nice sequential growth. So it's going well. And again, we're really looking forward to 2025 being a pivotal year for Reveal.

因此，我們看到了 Reveal 的同比增長和環比增長。所以進展順利。再次強調，我們非常期待 2025 年成為 Reveal 的關鍵一年。

Dan Arias, Stifel.

丹·阿里亞斯，斯蒂菲爾。

Hi, guys. Thanks for the question. Mike, on the acceleration that you're talking about for clinical volumes next year, how much are you attributing to international growth Japan and UK, what's the contribution like there? And then to your point on just Reveal, I guess, a clarification maybe, does that acceleration depend on getting surveillance on board as reimbursed by a particular date? Do you have less confidence in it if that process gets dragged out a bit into 2025?

嗨，大家好。謝謝你的提問。麥克，關於您所說的明年臨床數量的加速，您將多少歸因於日本和英國的國際成長，其中的貢獻是什麼？然後，對於您剛剛透露的觀點，我想，也許需要澄清一下，這種加速是否取決於在特定日期之前償還監控費用？如果這個過程被推遲到 2025 年，您是否會對此失去信心？

Yeah, Dan. Yeah, I would say, again, the main growth driver as we see the acceleration next year is still going to be Guardant360 in the US. And again, that's where we're seeing the main traction with Guardant360 LDT on Smart Liquid Biopsy. International, it's still a relatively low percentage of our overall volume. So I think we still expect to see growth internationally and particularly in Europe and the UK.

是的，丹。是的，我想說，明年的加速成長的主要動力仍然是美國的 Guardant360。這也是我們看到 Guardant360 LDT 對智慧液體活檢的主要吸引力。國際上，它占我們總銷售量的比例仍然相對較低。因此，我認為我們仍然期望看到國際上的成長，特別是在歐洲和英國。

But really, it's going to be dwarfed by what we see in the US. And for Reveal, yeah, I think, again, we're seeing good growth. We're managing that growth on Reveal. We're making really good progress on reducing the cost per test for Reveal. And so, we hope that, that can be implemented and put in place relatively -- in the relatively near future.

但實際上，與我們在美國看到的情況相比，這將相形見絀。對於 Reveal，是的，我認為我們再次看到了良好的成長。我們正在 Reveal 上管理這種成長。我們在降低 Reveal 每次測試成本方面取得了非常好的進展。因此，我們希望能夠在相對不久的將來實施並落實到位。

So, even without CRC surveillance reimbursement, I think we'll be at a place where our cost per test of Reveal is at the low end that we can start to push on Reveal and accelerate volumes even without a CRC surveillance reimbursement. And when that comes, then obviously, we'll move to being gross margin positive and we can really push a lot harder. So I think, yeah, regardless of the CRC surveillance reimbursement, I think we still expect to see an acceleration in Reveal, but that reimbursement is going to allow us to just really push a lot harder.

因此，即使沒有 CRC 監測報銷，我認為我們的每次 Reveal 測試成本也將處於較低水平，即使沒有 CRC 監測報銷，我們也可以開始推動 Reveal 並加速產量。當這種情況到來時，很明顯，我們將轉向毛利率為正，並且我們真的可以更加努力地推動。所以我認為，是的，不管 CRC 監測報銷如何，我認為我們仍然期望看到 Reveal 的加速，但報銷將使我們能夠更加努力地推動。

Eve Burstein, Bernstein Research.

伊芙‧伯斯坦，伯恩斯坦研究中心。

Hi, there. Thanks so much for taking the question. Maybe just following up actually on that international question. You said big drivers for G360 will be in the US and then primarily in Europe. And in late October, a new source indicated that you actually shut down your Shonan research center in Japan before launch (technical difficulty) that site and they attributed it to slow uptake of G360 in Japan specifically. So is that a fair characterization of why you shut that down? And can you add more color on the commercial traction that you are seeing in Japan? And what your expectations are for G360 there in the short and the medium term?

你好呀。非常感謝您提出問題。也許只是對這個國際問題進行實際跟進。您說過 G360 的主要動力將來自美國，然後主要是歐洲。10 月下旬，新消息來源表示，您實際上在啟動網站（技術困難）之前關閉了日本湘南研究中心，他們將其歸因於 G360 在日本的採用緩慢。那麼，這是您關閉該網站的合理描述嗎？您能否為您在日本看到的商業吸引力增添更多色彩？您對 G360 在短期和中期的期望是什麼？

Yeah. I mean, the lab closure we had there was really had no relationship to sort of any of our progress in Japan. It was just something that we had thought would make sense a number of years ago, especially when we had the sort of SoftBank JV, and it's not something that made sense at this point going forward. And so, we took the opportunity to really cut some costs over there. That being said, the ramp has been a little bit slower than we expected in Japan, but that has mostly to do with the way that reimbursement works there and the fact that essentially, these therapy selection tests are only reimbursed once for a lifetime regardless if it's tissue or liquid.

是的。我的意思是，我們在那裡關閉的實驗室實際上與我們在日本取得的任何進展都沒有關係。這只是我們幾年前認為有意義的事情，特別是當我們擁有類似軟銀合資企業的時候，而在目前的情況下，這並不是有意義的事情。因此，我們藉此機會真正削減了那裡的一些成本。話雖這麼說，日本的成長速度比我們預期的要慢一些，但這主要與那裡的報銷方式有關，而且事實上，從本質上講，這些治療選擇測試一生只報銷一次，無論是否它是組織或液體。

And so, tissue has more of a role there in terms of preferences right now. But we're very encouraged by some of the new programs we have there. And we think over time, we can start sort of moving forward and displacing some of the tissue volume that's there in Japan. So I think still going reasonably well. Just -- it will just take a little bit more time given the structural nature of the market there in Japan.

因此，就目前的偏好而言，紙巾在其中發揮更大的作用。但我們對那裡的一些新項目感到非常鼓舞。我們認為，隨著時間的推移，我們可以開始向前推進並取代日本的一些紙巾量。所以我認為進展還算順利。只是——考慮到日本市場的結構性質，這將需要更多的時間。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Hey good afternoon, guys. A quick one on guidance, and then I want to just try to do some Shield math and see if you'll bless it.

嘿，下午好，夥計們。快速指導一下，然後我想嘗試做一些盾牌數學，看看你是否會祝福它。

On guidance, you increased full year guidance, as you know, at the revenue line by almost $20 million. That's at the midpoint. Just wondered if you'd talk through the bridge. Is this essentially just the Q3 beat? Or is there more to it than that? Because if it's just the Q3 beat, I'm wondering if that really doesn't capture Shield momentum, G360 momentum with the new version and ASP bump, not to mention trends on more rapid collections. It just seems like the error bars might skew to the upside there. So I just want to see if you'll comment on that.

在指導方面，如您所知，您將全年指導收入增加了近 2000 萬美元。那是在中間點。只是想知道你是否會透過橋說話。這本質上只是第三季的節奏嗎？或者有比這更多的事情嗎？因為如果這只是第三季的節奏，我想知道這是否真的沒有捕捉到 Shield 的勢頭、新版本的 G360 的勢頭以及 ASP 的提升，更不用說更快速的收藏趨勢了。看起來誤差線可能會向上傾斜。所以我只是想看看你是否會對此發表評論。

And then on Shield, I'm going to take a shot at this. Development service gross margin was about 22%. That's about 40 points below trend. So that suggests COGS in that category were maybe $4 million higher than you would have expected pre Shield. So if we assume COGS per test of like $600 to $700, which is higher than your goal, but given the early stage of the ramp, it seems reasonable. It seems like you probably did 5,000 to 6,000 tests in the quarter. Any flow on the logic that you'd point out? Thank you.

然後在 Shield 上，我將對此進行嘗試。開發服務毛利率約22%。比趨勢低約 40 點。因此，這表明該類別中的 COGS 可能比您在屏蔽之前的預期高出 400 萬美元。因此，如果我們假設每次測試的 COGS 約為 600 至 700 美元，這高於您的目標，但考慮到斜坡的早期階段，這似乎是合理的。您在本季可能進行了 5,000 到 6,000 次測試。您指出的邏輯有什麼流程嗎？謝謝。

Yeah. Doug, I think there's a few factors in us increasing our guidance. And so, previously, it was $690 million to $700 million and now it's $720 million to $725 million. So, yes, something like a $27 million step-up at the midpoint. There's a few things in that. One of them, of course, is the cash upside from out-of-period payments that we saw and that I talked about in the prepared remarks.

是的。道格，我認為我們增加指導有幾個因素。因此，之前是 6.9 億至 7 億美元，現在是 7.2 億至 7.25 億美元。所以，是的，中間增加了 2700 萬美元。其中有一些事情。當然，其中之一是我們看到的、我在準備好的發言中談到的期外付款帶來的現金上漲。

The other is Guardant360 ASPs, and they've gone up consistently throughout the year, and now they're at $3,000. So we've got an uplift on the Guardant360 ASP. And then biopharma revenue, previously, we were guiding to sort of high-teens revenue growth. Now, we're guiding to high-20s revenue growth. So they're the real drivers.

另一個是 Guardant360 ASP，它們全年都在持續上漲，現在已經達到 3,000 美元。因此，我們對 Guardant360 ASP 進行了提升。然後是生物製藥收入，之前我們指導的是高青少年收入成長。現在，我們正在引導 20 多歲的人實現收入成長。所以他們才是真正的司機。

Of course, on top of that, we start now to have some revenue contribution from Shield. So that's also included there. The one thing that stayed consistent over the last few quarters has been our projection of clinical volumes being at 20%. And again, we reiterated that we're expecting to come in at with approximately 20% clinical volume growth. So that's where we are with that.

當然，除此之外，我們現在開始從 Shield 獲得一些收入貢獻。所以這也包括在那裡。過去幾季保持一致的一件事是我們對臨床量的預測為 20%。我們再次重申，我們預計臨床數量將增加約 20%。這就是我們現在的情況。

I think, yeah, on your -- trying to back into sort of some of the Shield volumes, I think some of that's a bit off. One thing that we can talk about or want to talk about is the cost per test. And so, prior to the launch, that cost per test was over $1,000, and a lot of that built into the cost was the fixed cost. And so, as we've gone into launch now, as we've started to see traction with the volume, we're seeing that cost per test come down pretty rapidly. So now it's below $1,000, and we expect that to continue to reduce over the next few quarters.

我想，是的，關於你的——試圖回到一些盾牌卷中，我認為其中有些有點不對勁。我們可以談論或想要談論的一件事是每次測試的成本。因此，在發布之前，每次測試的成本超過 1,000 美元，其中很大一部分是固定成本。因此，隨著我們現在開始發布，隨著我們開始看到銷售的成長，我們發現每次測試的成本下降得相當快。所以現在它低於 1,000 美元，我們預計未來幾季該價格將繼續下降。

And again, we've set this target for -- to be gross margin neutral, gross margin positive when we get the ADLT rate. And so, I think we're well on track with the cost reduction on Shield together.

再一次，我們設定的目標是－當我們獲得 ADLT 利率時，毛利率為中性，毛利率為正。因此，我認為我們在 Shield 成本降低方面進展順利。

Thank you. That's all the questions that we have time for today. This now concludes today's call. Thank you all for joining. You may now disconnect your lines.

謝謝。這就是我們今天有時間回答的所有問題。今天的電話會議到此結束。感謝大家的加入。現在您可以斷開線路。