Veracyte Inc (VCYT) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the Veracyte first-quarter 2025 financial results webcast. (Operator Instructions)

您好，感謝您的支持。歡迎收聽 Veracyte 2025 年第一季財務業績網路廣播。（操作員指示）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Shayla Gorman, Senior Director, Investor Relations. Please go ahead.

請注意，今天的會議正在錄音。現在，我想將會議交給今天的第一位發言者，投資者關係高級總監 Shayla Gorman。請繼續。

Good afternoon, everyone, and thank you for joining us today for a discussion of our first-quarter 2025 financial results. With me today are Marc Stapley, Veracyte's Chief Executive Officer; Rebecca Chambers, our Chief Financial Officer; and John Leite, our Chief Commercial Officer, who will join us for Q&A.

大家下午好，感謝您今天加入我們討論 2025 年第一季的財務表現。今天與我一起參加的是 Veracyte 執行長 Marc Stapley、我們的財務長麗貝卡·錢伯斯 (Rebecca Chambers) 和我們的首席商務官約翰·萊特 (John Leite)，他們將與我們一起進行問答。

Veracyte issued a press release earlier this afternoon detailing our first quarter 2025 financial results. This release and a copy of the presentation we will review during the call today, are available in the Investors section of our website at veracyte.com. Before we begin, I'd like to remind you that statements we make during this call will include forward-looking statements as defined under applicable securities laws.

Veracyte 今天下午早些時候發布了一份新聞稿，詳細介紹了我們 2025 年第一季的財務表現。本新聞稿以及我們將在今天的電話會議上審查的簡報副本，可在我們網站 veracyte.com 的「投資者」板塊取得。在開始之前，我想提醒您，我們在本次電話會議上所做的陳述將包含適用證券法所定義的前瞻性陳述。

Forward-looking statements are subject to risks and uncertainties, and the company can give no assurance they will prove to be correct. Additionally, we are not under any obligation to provide further updates on our business trends or our performance during the quarter. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Veracyte files with the Securities and Exchange Commission, including the most recent Forms 10-Q and 10-K.

前瞻性陳述受風險和不確定性的影響，公司不能保證其正確性。此外，我們沒有義務提供本季業務趨勢或業績的進一步更新。為了更了解可能導致實際結果不同的風險和不確定性，我們請您參閱 Veracyte 向美國證券交易委員會提交的文件，包括最新的 10-Q 表和 10-K 表。

In addition, this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures are included in today's earnings release accessible from the Investors section of Veracyte's website.

此外，本次電話會議還將包括某些非公認會計準則財務指標。這些指標與最直接可比較的 GAAP 財務指標的對帳包含在今天的收益報告中，可從 Veracyte 網站的「投資者」部分存取。

I will now turn the call over to Marc Stapley, Veracyte's CEO.

現在我將把電話轉給 Veracyte 的執行長 Marc Stapley。

Thank you, Shayla, and thanks, everyone, for joining us today. I am pleased to share our Q1 results as well as updates on our growth drivers and other key initiatives, all of which are the result of our team's daily focus on serving patients globally. Q1 total revenue of $114.5 million or 18% year-over-year growth was fueled by testing revenue, which grew 19% year over year or 21% after adjusting for Envisia.

謝謝你，Shayla，也謝謝大家今天加入我們。我很高興與大家分享我們的第一季業績以及成長動力和其他關鍵舉措的最新情況，所有這些都是我們團隊每天專注於為全球患者服務的結果。第一季總收入為 1.145 億美元，年增 18%，主要得益於測試收入，該收入年增 19%，經 Envisia 調整後成長 21%。

With both Decipher and Afirma delivering another strong quarter of double-digit volume growth, 37% and 10%, respectively, we are encouraged by the ongoing durability of our core testing business and are confident in delivering on our expectations for this year and beyond, despite the challenging macroenvironment. We delivered a healthy adjusted EBITDA margin of 21.6%, meaningfully higher than we expected and ended the quarter with a strong balance sheet comprising $287 million of cash and short-term investments.

Decipher 和 Afirma 本季均實現了兩位數的強勁成長，增幅分別為 37% 和 10%，儘管宏觀環境充滿挑戰，但我們對核心測試業務的持續穩健性感到鼓舞，並有信心實現今年及以後的預期。我們實現了健康的調整後 EBITDA 利潤率 21.6%，遠高於我們的預期，本季結束時我們的資產負債表表現強勁，包括 2.87 億美元的現金和短期投資。

As you know, we are focused on a number of strategic initiatives, including: growing our existing tests, Decipher and Afirma; expanding across the care continuum with our minimal residual disease platform; expanding internationally; and solving novel cancer challenges with innovative products like our Percepta Nasal Swab.

如您所知，我們專注於多項策略舉措，包括：擴展我們現有的測試，Decipher 和 Afirma；利用我們的微小殘留疾病平台擴展整個護理過程；進行國際擴張；以及利用我們的 Percepta 鼻拭子等創新產品解決新的癌症挑戰。

Today, I'm excited to share our progress and some new initiatives. Starting with Decipher. The impressive 37% year-over-year volume growth resulted in approximately 22,600 tests and revenue growth of 33%, with the driver of this difference being higher prior period collections last year. Encouragingly, we continue to see broad-based expansion across each biopsy NCCN risk category with roughly similar growth in low, intermediate and high risk.

今天，我很高興與大家分享我們的進展和一些新措施。從解密開始。與去年同期相比，令人印象深刻的 37% 的成長帶來了約 22,600 次測試和 33% 的收入成長，而這一差異的驅動因素是去年前期收集量較高。令人鼓舞的是，我們繼續看到每個活檢 NCCN 風險類別的廣泛擴展，低風險、中風險和高風險的成長大致相同。

Further, this quarter, we saw both a record number of ordering providers, up over 20% from the prior year and increased orders per physician. While January and February were, as previously shared, seasonally lower months, March was exceptional, and that strong momentum continued in April. We believe these positive trends are a testament to the recent NCCN guideline update as well as the excellent execution of our commercial and laboratory teams.

此外，本季度，我們看到訂購提供者的數量創下了歷史新高，比去年增長了 20% 以上，而且每位醫生的訂單量也有所增加。如同先前所述，一月和二月是季節性低迷的月份，但三月表現突出，四月也延續了強勁勢頭。我們相信這些積極的趨勢證明了最近的 NCCN 指南更新以及我們的商業和實驗室團隊的出色執行力。

Looking ahead, there are a number of activities that position us for sustained strong double-digit Decipher growth. With meaningfully differentiated performance and an incredible body of clinical evidence, Decipher is already in a field of its own.

展望未來，我們採取了一系列措施，確保 Decipher 能持續強勁的兩位數成長。憑藉顯著的差異化表現和令人難以置信的大量臨床證據，Decipher 已在自己的領域中獨樹一幟。

At the recent AUA Annual Meeting in April, there were no less than 18 new abstracts presented across both Decipher Prostate and Bladder, including new data from the use of Decipher in clinical trials as well as insights derived from the research use on GRID platform. We are also progressing across the care continuum with our Decipher Prostate metastatic launch.

在四月舉行的 AUA 年會上，Decipher Prostate 和 Bladder 上發表了不少於 18 篇新摘要，其中包括 Decipher 在臨床試驗中的新數據以及從 GRID 平台研究使用中獲得的見解。隨著 Decipher Prostate 轉移性療法的推出，我們在整個護理過程中也取得了進展。

As of late April, Decipher Prostate is available for use in the metastatic population on a limited basis and will be available broadly in June, meeting our expected launch timeline. The clinical validity and clinical utility for use in this patient population has been demonstrated in multiple prospective Phase III clinical studies, including the results from the STAMPEDE trial presented at ESMO Congress 2024.

截至 4 月底，Decipher Prostate 已在轉移性患者中有限度地可用，並將於 6 月廣泛推廣，符合我們預期的發佈時間表。多項前瞻性 III 期臨床研究已證明了該患者群體的臨床有效性和臨床實用性，包括在 2024 年 ESMO 大會上展示的 STAMPEDE 試驗的結果。

Importantly, the test will provide information to help clinicians determine which patients will likely benefit from chemotherapy and which will not, thereby avoiding unnecessary toxic side effects. One such case involves an older man who was diagnosed with metastatic disease. His doctor ordered the test to help guide treatment selection between doublet therapy, that is ADT plus ARPI, and triplet therapy with the addition of docetaxel.

重要的是，該測試將提供資訊幫助臨床醫生確定哪些患者可能受益於化療，哪些患者不會，從而避免不必要的毒性副作用。其中一個案例涉及一位被診斷患有轉移性疾病的老年男子。他的醫生要求進行此項測試，以幫助指導在雙聯療法（即 ADT 加 ARPI）和三聯療法（加多西他賽）之間選擇治療方法。

Although the patient is fit, active and fully independent, his physician was concerned about adding the chemotherapy. The Decipher Prostate metastatic test will provide an additional data point for the physician and patient as they make the treatment decisions necessary at this critical phase of the disease, balancing the likely benefit with the impact on quality of life. This launch meaningfully expands the population appropriate for Decipher testing, serving an incremental 30,000 patients diagnosed annually and now addressing the entire risk spectrum of prostate cancer, further strengthening our confidence in the test's long-term growth trajectory.

儘管患者健康、活躍且完全獨立，但他的醫生仍擔心增加化療。Decipher 前列腺轉移測試將為醫生和患者提供額外的數據點，幫助他們在疾病的關鍵階段做出必要的治療決策，平衡可能的益處和對生活品質的影響。此次發布顯著擴大了 Decipher 檢測的適用人群，每年為新增的 30,000 名患者提供服務，目前可解決前列腺癌的整個風險範圍，進一步增強了我們對該檢測長期增長軌蹟的信心。

We have also continued our investment in digital pathology studies to assess the complementary benefits of the technology as well as to ensure research collaborators have the necessary tools to further our collective understanding of prostate cancer. In addition to the data presented at the 2025 ASCO GU earlier in the year, we have now scanned over 70,000 slides from over 40,000 deidentified patients with outcomes data, solidifying our digital pathology capabilities with advanced AI models that incorporate long-term outcomes and may ultimately complement the prognostic power of our Decipher test.

我們也繼續投資數位病理學研究，以評估該技術的互補優勢，並確保研究合作者擁有必要的工具來進一步加深對前列腺癌的集體了解。除了今年稍早在 2025 年 ASCO GU 上展示的數據之外，我們現在還掃描了來自 40,000 多名已去識別患者的 70,000 多張載玻片，其中包含結果數據，透過結合長期結果的先進 AI 模型鞏固了我們的數位病理學能力，並可能最終補充我們的 Decipher 測試的預後能力。

Further, we have recently made our digital pathology services and associated AI models available to research collaborators to advance the science in the field of combined AI-based imaging and molecular analysis.

此外，我們最近向研究合作者提供了我們的數位病理學服務和相關的人工智慧模型，以推動基於人工智慧的成像和分子分析領域的科學發展。

Looking ahead, with the most prolific and growing body of real-world evidence, NCCN guideline recommendation and now the expansion into the metastatic patient, Decipher's opportunity to significantly penetrate the nascent and growing prostate cancer market is even clearer. We look forward to continuing to drive meaningful growth for the Decipher franchise for years to come.

展望未來，憑藉最豐富且不斷增長的真實世界證據、NCCN 指南推薦以及現在向轉移性患者的擴展，Decipher 大幅滲透新興且不斷增長的前列腺癌市場的機會更加清晰。我們期待在未來幾年繼續推動 Decipher 系列的有意義的成長。

Moving to Afirma. Volume growth continues to be strong and increased, as I mentioned previously, 10% year over year, resulting in approximately 15,500 tests. We were encouraged to see higher year-over-year utilization per account again this quarter, which gives us confidence in the go-forward durability of the Afirma franchise.

移至 Afirma。正如我之前提到的，數量成長持續強勁，年增 10%，達到約 15,500 次測試。我們很高興地看到本季度每個帳戶的同比利用率再次上升，這讓我們對 Afirma 特許經營的未來持久性充滿信心。

Revenue growth was lower than volume growth, driven by the prior period collection benefit in 2024 as well as the negative impact of our lab benefit managers' mistaken coverage policy change last year. While the mistake was quickly corrected, it took longer than anticipated to be worked through the respective payer systems and therefore, reduced collections below the amount estimated over the course of 2024.

收入成長低於銷售成長，原因是 2024 年的上期收款收益以及去年實驗室福利經理錯誤的核保政策變化帶來的負面影響。雖然錯誤很快就得到糾正，但透過相應的付款系統處理所花費的時間比預期的要長，因此導致 2024 年的收款金額低於預期金額。

This has been fully resolved. However, we are still adjudicating some of these claims and the full return to normal rates may take another quarter or two to be reflected. With the volume strength we're seeing as well as indication expansion and the product enhancements we've delivered, our confidence remains strong that Afirma will continue to gain in both share and penetration.

此事已徹底解決。然而，我們仍在審理其中一些索賠，並且可能還需要一兩個季度才能完全恢復正常利率。憑藉我們所看到的銷售實力以及適應症的擴大和產品增強，我們堅信 Afirma 將繼續在市場份額和滲透率方面獲得成長。

We expect the first presentation of independent analysis leveraging the GRID database later this month at AAES and look forward to sharing additional publications and poster presentations that advance thyroid nodules and cancer research.

我們預計本月晚些時候將在 AAES 上首次展示利用 GRID 資料庫的獨立分析，並期待分享更多推動甲狀腺結節和癌症研究的出版物和海報展示。

As with Decipher, the flywheel of research and evidence around the test is representative of the power of the Veracyte Diagnostics Platform and will enable efficient evidence generation and insights that will help expand patient treatment and ultimately, we expect will drive continued growth.

與 Decipher 一樣，圍繞測試的研究和證據飛輪代表了 Veracyte 診斷平台的強大功能，並將實現高效的證據生成和洞察，從而幫助擴大患者治療，並最終推動持續增長。

While on the topic of Afirma, I'm excited to share key advancements that we are making in our CLIA lab. Over the past two years, we have invested in improving the efficiency of our testing business. As part of our overall COGS reduction road map, we have been working to transition Afirma onto v2 of our Veracyte transcriptome running on the latest and most cost-effective sequencing technology.

談到 Afirma，我很高興分享我們在 CLIA 實驗室取得的關鍵進展。在過去的兩年裡，我們投入了大量資金來提高測試業務的效率。作為我們整體 COGS 削減路線圖的一部分，我們一直致力於將 Afirma 過渡到採用最新、最具成本效益的定序技術的 Veracyte 轉錄組 v2。

We will first launch Afirma on the updated assay this summer. This transition enables cost reductions that are designed to offset normal reagent list price increases we might experience in 2026 and beyond, while also helping to mitigate unpredictable tariff impacts and to potentially enable us to reinvest in organic opportunities to serve more patients.

我們將於今年夏天首次推出更新後的 Afirma。此次轉變可以降低成本，以抵消我們在 2026 年及以後可能經歷的正常試劑標價上漲，同時也有助於減輕不可預測的關稅影響，並有可能使我們能夠重新投資於有機機會，為更多患者提供服務。

I'm also excited to be able to announce today that we have decided to launch Prosigna as an LDT for the US breast cancer market given the tremendous opportunity we see ahead. There are over 300,000 patients diagnosed annually with breast cancer in the US and approximately 225,000 of those have early-stage hormone receptor positive disease and would be eligible for the test.

今天，我很高興能夠宣布，鑑於我們看到的巨大機遇，我們決定推出 Prosigna 作為美國乳癌市場的 LDT。美國每年有超過 30 萬名患者被診斷出患有乳癌，其中約 225,000 名患者患有早期荷爾蒙受體陽性疾病，有資格接受該檢測。

Prosigna, which is based on the well-known, well-researched and scientifically respected PAM50 signature, can provide physicians and their patients with additional data around the biological classification of the cancer and the risk of recurrence to help inform treatment decisions.

Prosigna 基於眾所周知、經過充分研究且受到科學尊重的 PAM50 特徵，可以為醫生及其患者提供有關癌症生物學分類和復發風險的額外數據，以幫助制定治療決策。

While Prosigna is currently available only as an IVD on the nCounter platform, the Prosigna LDT will be run out of our CLIA lab using our brand-new v2 Veracyte transcriptome. Commercial availability will begin in mid-2026 and we believe key data readouts, some of which we'll see in the next few months, will support adoption of Prosigna, augmenting Decipher and Afirma growth in the near to mid-term.

雖然 Prosigna 目前在 nCounter 平台上僅作為 IVD 使用，但 Prosigna LDT 將使用我們全新的 v2 Veracyte 轉錄組在我們的 CLIA 實驗室中運行。商業化將於 2026 年中期開始，我們相信關鍵數據讀數（其中一些將在未來幾個月內看到）將支持 Prosigna 的採用，從而在近期至中期內增強 Decipher 和 Afirma 的成長。

As always, we are focused on driving evidence for the test through the Veracyte Diagnostics Platform to support continued research for patients navigating the stressful diagnosis and associated treatment paths. Moving to the other growth drivers mentioned previously, I would like to start with our commitment to serve more of the patient journey through MRD and recurrence testing. Our MRD approach is differentiated in that it is whole genome every step of the way, including the initial baseline sequencing, followed by the sequencing of serial testing samples.

與往常一樣，我們專注於透過 Veracyte 診斷平台推動測試證據，以支持患者在壓力診斷和相關治療途徑中繼續進行研究。談到前面提到的其他成長動力，我想先談談我們致力於透過 MRD 和復發檢測為更多患者提供服務的承諾。我們的 MRD 方法與眾不同之處在於，每一步都是全基因組，包括初始基線定序，然後是連續測試樣本的定序。

This approach is backed by our fundamental belief that more data drives more insights, more clinical evidence, more payer coverage and therefore, more durable adoption. We have made good progress in advancing our MRD platform for our first indication, muscle invasive bladder cancer. This indication will leverage our strong Decipher channel that serves urologists and radiation oncologists.

這種方法基於我們的基本信念：更多的數據可以帶來更多的見解、更多的臨床證據、更多的付款人覆蓋，從而帶來更持久的採用。我們在推進 MRD 平台治療我們的第一個適應症——肌層浸潤性膀胱癌方面取得了良好進展。這一適應症將利用我們為泌尿科醫生和放射腫瘤學家服務的強大的 Decipher 管道。

In March, we submitted our tech assessment to MolDx and remain on track for commercial launch in the first half of 2026 once we have reimbursement in place. While we are initially focused on MIBC, beginning in 2027, we plan to deliver indication expansion annually, serving more patients across more indications.

今年 3 月，我們向 MolDx 提交了技術評估，並計劃在獲得報銷後於 2026 年上半年進行商業發布。雖然我們最初專注於 MIBC，但從 2027 年開始，我們計劃每年擴展適應症，為更多適應症的患者提供服務。

Building out the clinical evidence behind our platform is key to our go-to-market approach. We are excited to share that our MRD platform was selected for the important UMBRELLA trial being run out of Institute Gustave Roussy on approximately 700 patients with non-small cell lung cancer, colorectal cancer, soft tissue sarcoma and pancreatic cancer as well as leveraging MRD-positive status to direct IO therapy. UMBRELLA investigators chose our MRD platform given its tissue-agnostic analytics validation, which enables the trial to include multiple tumor types.

建立我們平台背後的臨床證據是我們進入市場的關鍵。我們很高興地告訴大家，我們的 MRD 平台被選為古斯塔夫·魯西研究所開展的重要 UMBRELLA 試驗的一部分，該試驗對大約 700 名非小細胞肺癌、結直腸癌、軟組織肉瘤和胰腺癌患者進行了研究，並利用 MRD 陽性狀態來指導 IO 治療。UMBRELLA 研究人員選擇了我們的 MRD 平台，因為它具有組織不可知的分析驗證，這使得試驗能夠涵蓋多種腫瘤類型。

The data from some of these indications will be pivotal as we look to expand our test beyond MIBC in the future. Further, strong performance data from the multicenter, interventional TOMBOLA clinical trial was presented at the Annual European Association of Urology, EAU Congress, in March 2025, supporting the accuracy of our whole genome sequencing-based MRD platform for MIBC.

當我們尋求在未來將測試擴展到 MIBC 之外時，來自這些指徵中的一些數據將至關重要。此外，2025 年 3 月在歐洲泌尿外科協會 (EAU) 年度大會上展示了多中心介入性 TOMBOLA 臨床試驗的強勁性能數據，支持了我們基於全基因組測序的 MIBC MRD 平台的準確性。

This data showed that our test had a higher specificity, equivalent and outstanding negative predictive value when compared to a ddPCR approach and was able to detect cancer recurrence, a median of 93 days sooner than standard imaging. Next, turning to our geographic expansion strategic growth driver, where we are committed to launching our tests as IVDs to address patient needs outside the US, I would like to update you on the ongoing process with our French subsidiary, Veracyte SAS, or SAS.

這些數據表明，與 ddPCR 方法相比，我們的測試具有更高的特異性、等效和出色的陰性預測值，並且能夠檢測到癌症復發，比標準成像提前中位數 93 天。接下來，談到我們的地理擴張策略成長動力，我們致力於推出 IVD 測試，以滿足美國以外的患者需求，我想向您介紹我們法國子公司 Veracyte SAS 或 SAS 正在進行的進程。

As I had previously shared, Veracyte, Inc. notified SAS that we were considering no longer funding their operations. As a result, SAS engaged in consultation proceedings with the Works Council in France, while also seeking to identify one or more buyers for all or parts of the SAS activities.

正如我之前所分享的，Veracyte, Inc. 通知 SAS，我們正在考慮不再為其營運提供資金。因此，SAS 與法國工會委員會展開了協商程序，同時也尋求為 SAS 全部或部分業務尋找一個或多個買家。

In late April, Veracyte, Inc. notified SAS that Inc. definitively decided to no longer fund the entity and accordingly, SAS filed a bankruptcy petition shortly thereafter. We remain confident in a full resolution of SAS proceedings by the end of the year, at which time Veracyte, Inc. would no longer own or operate the Marseille facility.

4 月下旬，Veracyte 公司通知 SAS，該公司最終決定不再為該實體提供資金，因此，SAS 隨後不久提交了破產申請。我們仍然相信 SAS 訴訟將在年底前得到全面解決，屆時 Veracyte, Inc. 將不再擁有或經營馬賽工廠。

We are focused on maintaining Prosigna supply to help minimize patient impact as much as we can. SAS and its financial advisers are working to identify potential buyers for portions of the business and any sale would be handled by the commercial court as part of the proceedings.

我們專注於維持 Prosigna 的供應，以盡可能減少對患者的影響。SAS 及其財務顧問正在努力尋找部分業務的潛在買家，任何出售都將由商業法庭作為訴訟程序的一部分處理。

Our decision to no longer fund SAS does not reflect a change of strategy or our commitment to global expansion, but this process does inevitably impact our IVD product development timelines, as previously shared. Importantly, we have made significant progress on these products. For example, our Decipher PCR IVD product is bridged and partially validated with a single pilot launch, thereby meaningfully reducing technical risk.

我們決定不再資助 SAS 並不反映策略的改變或我們對全球擴張的承諾，但這個過程不可避免地會影響我們的 IVD 產品開發時間表，正如之前所分享的。重要的是，我們在這些產品上取得了重大進展。例如，我們的 Decipher PCR IVD 產品透過單一試點發布進行橋接和部分驗證，從而顯著降低技術風險。

We are now in the process of reinitiating that development program in the US, working with a US-based contract manufacturer and expect to complete our joint development and manufacturing work by the end of next year. Similarly, we now expect to complete our Prosigna NGS IVD product development work by the end of 2026 as well, working with a different third-party contract manufacturer.

我們目前正在美國重新啟動該開發計劃，與美國合約製造商合作，預計將於明年年底完成聯合開發和製造工作。同樣，我們現在也預計將在 2026 年底前完成 Prosigna NGS IVD 產品開發工作，並與另一家第三方合約製造商合作。

We continue to work with TUV [Rheinland], our notified body, and are in the process of resubmitting Prosigna nCounter to their North America division. These steps will all be necessary to launch our IVD products in Europe, along with gaining reimbursement country-by-country, which as always, will take some time. Importantly, we don't believe this change in development and certification time lines meaningfully impacts our revenue models for the next five years.

我們繼續與我們的認證機構 TUV [Rheinland] 合作，並正在將 Prosigna nCounter 重新提交給其北美分部。這些步驟對於我們在歐洲推出 IVD 產品都是必要的，同時也要逐個國家獲得報銷，而這通常需要一些時間。重要的是，我們不認為開發和認證時間表的這種變化會對我們未來五年的收入模式產生重大影響。

And in fact, we expect that any delay of IVD product revenue will be more than offset by the launch in the US next year of our Prosigna LDT. Our last growth driver is solving new cancer challenges with innovative products like our Percepta Nasal Swab, to which we remain very committed, as evidenced by our major investment in clinical evidence.

事實上，我們預計 IVD 產品收入的任何延遲都將被明年在美國推出的 Prosigna LDT 所抵消。我們最後的成長動力是透過 Percepta 鼻拭子等創新產品解決新的癌症挑戰，我們對此保持高度重視，我們對臨床證據的大量投資就證明了這一點。

Lung cancer is the leading cause of death worldwide and early detection and management is key to reducing mortality and improving outcomes. Percepta Nasal Swab is a simple, non-invasive test that assesses lung cancer risk in patients with a detected lung nodule and smoking history so that the right patients get the right intervention at the right time.

肺癌是世界各地的首要死亡原因，早期發現和管理是降低死亡率和改善治療效果的關鍵。Percepta 鼻拭子是一種簡單、非侵入性的測試，可以評估檢測到肺結節並有吸煙史的患者的肺癌風險，以便合適的患者在合適的時間得到合適的干預。

In the first quarter, we were pleased to publish nasal swab analytical validity data in BMC Cancer, demonstrating the robustness of the test. This publication as well as completion of the prospective NIGHTINGALE study are key steps in our effort to bring this important test to patients.

第一季度，我們很高興在《BMC Cancer》上發表了鼻拭子分析有效性數據，證明了該測試的穩健性。此次發表以及前瞻性 NIGHTINGALE 研究的完成是我們努力將這項重要測試帶給患者的關鍵步驟。

With a target of 2,400 patients, NIGHTINGALE is now close to 95% enrolled and with just over 100 patients left to register, we are now confident in predicting completion of enrollment in the third quarter. Then we will be able to commence the important follow-up and data analysis leading to publication and ultimately, reimbursement.

NIGHTINGALE 的目標是 2,400 名患者，目前已完成近 95% 的報名，還剩下 100 多名患者尚未報名，我們現在有信心預測第三季將完成報名。然後，我們將能夠開始重要的後續工作和數據分析，最終獲得出版和報銷。

To summarize, at Veracyte, everything we do is to advance our vision of transforming cancer care to improve patient lives all over the world. Leveraging our unique Veracyte Diagnostics Platform, we deliver the deep insights that physicians can rely on today, while continuously fueling the flywheel of evidence needed to solve new cancer challenges tomorrow. Q1 was another amazing quarter, demonstrating our capabilities to this end.

總而言之，在 Veracyte，我們所做的一切都是為了推進我們改變癌症治療的願景，以改善全世界患者的生活。利用我們獨特的 Veracyte 診斷平台，我們可以為醫生提供當今可以依賴的深刻見解，同時不斷為解決未來新的癌症挑戰提供所需的證據飛輪。第一季又是一個令人驚嘆的季度，展示了我們在這方面的能力。

We saw incredible volume growth across our core testing business, meaningful strides in our COGS reduction road map, progress on our commitment to launch new CLIA test starting with Prosigna LDT and great progress across all of our long-term growth drivers during the quarter.

我們的核心測試業務量實現了令人難以置信的成長，我們的 COGS 削減路線圖取得了有意義的進展，我們從 Prosigna LDT 開始推出新的 CLIA 測試的承諾取得了進展，並且我們所有的長期成長動力在本季度都取得了巨大進展。

We have a rich and exciting portfolio of products in development over the next few years and beyond, and I'm confident these activities as well as others we're working on, will enable us to serve even more patients facing cancer, ensuring we are living our ethos of patients as our purpose.

在未來幾年及以後，我們將開發豐富而令人興奮的產品組合，我相信這些活動以及我們正在進行的其他活動將使我們能夠為更多的癌症患者提供服務，確保我們以患者為本的精神為宗旨。

With that, I will now turn to Rebecca to review our financial results for the first quarter as well as our outlook for 2025.

現在，我將請麗貝卡回顧我們第一季的財務表現以及 2025 年的展望。

Thanks, Marc. As mentioned, Q1 was a strong start to the year as we delivered revenue of $114.5 million, an increase of 18% over the prior year period.

謝謝，馬克。如上所述，第一季我們取得了強勁的開局，營收達到 1.145 億美元，比去年同期成長了 18%。

Further, total volume grew to approximately 40,650 tests, a 22% increase over the same period in 2024. Testing revenue during the quarter was $107.3 million, an increase of 19% year-over-year, driven by Decipher and Afirma revenue growth of 33% and 6% respectively. Total testing volume was approximately 38,000 tests.

此外，總測試量成長至約 40,650 次，比 2024 年同期成長 22%。本季測試營收為 1.073 億美元，年增 19%，其中 Decipher 和 Afirma 營收分別成長 33% 和 6%。總測試量約為 38,000 次。

Testing ASP was $2,818, down 3% compared to the prior year and includes approximately $600,000 of prior period collections, or PPCs. Adjusting for the impact of PPC, testing ASP would have been approximately $2,800, roughly flat compared to Q1 2024. Turning to the product line.

測試 ASP 為 2,818 美元，比上年下降 3%，其中包括約 60 萬美元的前期收款或 PPC。調整 PPC 的影響後，測試 ASP 約為 2,800 美元，與 2024 年第一季相比基本持平。轉向產品線。

First-quarter volume was approximately 2,570 tests and revenue was $3.6 million, up 1% year-over-year as our actions to maintain continuity of supply over the quarter were more successful than anticipated. Biopharmaceutical and other revenue was $3.6 million, up 19% year-over-year as SAS customers accelerated programs given Veracyte, Inc.'s impending financing decision.

第一季的測試量約為 2,570 次，營收為 360 萬美元，年增 1%，因為我們在本季維持供應連續性的行動比預期更為成功。生物製藥和其他收入為 360 萬美元，年增 19%，因為 SAS 客戶在 Veracyte, Inc. 即將做出融資決定的情況下加快了專案。

Moving to gross margin and operating expenses. I will highlight our non-GAAP results. Non-GAAP gross margin was 72%, up approximately 400 basis points compared to the prior year period. Testing gross margin was 74%, up approximately 200 basis points, given timing of material spend as well as the benefit of automation and lab efficiency programs that we launched late last year. Product margin was 60%, up materially from the prior year period given higher cost absorption.

轉向毛利率和營業費用。我將重點介紹我們的非公認會計準則結果。非公認會計準則毛利率為 72%，較去年同期上升約 400 個基點。測試毛利率為 74%，上漲約 200 個基點，這得益於材料支出的時間安排以及我們去年年底推出的自動化和實驗室效率計劃帶來的好處。產品利潤率為 60%，由於成本吸收率較高，較去年同期大幅上升。

Biopharmaceutical and other gross margin was 27%, up 18% year-over-year. Non-GAAP operating expenses were up 14% year-over-year at $60.5 million. Research and development expenses increased by $2.1 million to $15.7 million, given increased development spend and one additional month of personnel expense from our C2i acquisition as compared to the prior year period. Sales and marketing expenses increased by $0.8 million to $22.5 million. G&A expenses were up $4.5 million to $22.3 million, partially driven by billing and customer service hiring to support our scaling testing business and IT support for product development projects.

生物製藥及其他毛利率為27%，較去年同期成長18%。非公認會計準則營運費用年增 14% 至 6,050 萬美元。由於開發支出增加以及收購 C2i 導致人員費用增加一個月，與去年同期相比，研發費用增加了 210 萬美元，達到 1,570 萬美元。銷售和行銷費用增加了 80 萬美元，達到 2,250 萬美元。一般及行政費用增加了 450 萬美元，達到 2,230 萬美元，部分原因是招聘計費和客戶服務人員來支援我們的擴展測試業務和為產品開發項目提供 IT 支援。

Moving to profitability metrics. Our financial profile continues to be best-in-class, driven by our disciplined approach. In the first quarter, we recorded GAAP net income of $7 million and delivered adjusted EBITDA of $24.7 million or 21.6% of revenue, well ahead of expectations as we benefited from our lab efficiency projects as well as the timing of project spend. Turning to our second quarter outlook. We expect testing revenue to step up sequentially.

轉向盈利指標。在我們嚴謹的作風的推動下，我們的財務狀況繼續保持最佳水平。第一季度，我們記錄的 GAAP 淨收入為 700 萬美元，調整後 EBITDA 為 2,470 萬美元，佔收入的 21.6%，遠遠超出預期，因為我們受益於實驗室效率項目以及項目支出的時間安排。談談我們對第二季的展望。我們預計測試收入將逐步增加。

For gross margin, we're expecting a modest step down sequentially given lower fixed cost absorption at our Marseille site and the timing of consumable spend in our testing business. Based on the current SAS dynamic, we expect product revenue of approximately $2.5 million, while biopharma and other revenue is expected to be approximately $1.5 million.

對於毛利率，我們預計將出現連續小幅下降，因為我們馬賽工廠的固定成本吸收較低，而且我們的測試業務中消耗品的支出時間較長。根據目前的 SAS 動態，我們預計產品收入約為 250 萬美元，而生物製藥和其他收入預計約為 150 萬美元。

Going forward, product revenue should remain flat sequentially as long as we are able to maintain continuity of supply for Prosigna on nCounter and minimize customer disruption. For biopharma and other, once the SAS process concludes, most of this revenue will go away. Given our solid Q1 results, we are reiterating our 2025 testing revenue guidance of $470 million to $480 million.

展望未來，只要我們能夠維持 nCounter 上 Prosigna 的連續供應並最大限度地減少客戶中斷，產品收入就應該保持穩定。對於生物製藥和其他產業來說，一旦 SAS 流程結束，大部分收入將會消失。鑑於我們第一季的穩健業績，我們重申 2025 年測試收入預期為 4.7 億至 4.8 億美元。

Due to our strong Q1 performance and the gross margin improvement projects we expect to benefit from in the second half, we are raising adjusted EBITDA margin guidance for the year to 22.5% from 21.6% previously. Also, we are estimating our 2025 GAAP and non-GAAP tax rate to be in the mid-single-digits. In closing, we were encouraged by the performance of both Afirma and Decipher in the first quarter and the value we're delivering to both patients and clinicians.

由於我們第一季的強勁表現以及我們預計下半年將受益的毛利率改善項目，我們將今年的調整後 EBITDA 利潤率預期從先前的 21.6% 上調至 22.5%。此外，我們估計 2025 年 GAAP 和非 GAAP 稅率將達到中位數個位數。最後，Afirma 和 Decipher 在第一季的表現以及我們為患者和臨床醫生提供的價值令我們感到鼓舞。

With a robust set of growth drivers, including the recent launch of Decipher in the metastatic population and the upcoming launch of our Prosigna LDT, we are well positioned to deliver sustained growth in our business. Above all, we remain deeply committed to our mission of transforming cancer care and improving patient lives all over the world.

憑藉強勁的成長動力，包括最近推出的針對轉移性患者的 Decipher 和即將推出的 Prosigna LDT，我們已準備好實現業務的持續成長。最重要的是，我們仍然堅定地致力於改變癌症治療和改善全世界患者生活的使命。

We'll now turn to the Q&A portion of the call.

我們現在進入電話會議的問答部分。

(Operator Instructions) Subbu Nambi, Guggenheim Securities.

（操作員指示）Subbu Nambi，古根漢證券。

There are two topics that I want to -- I would like to cover. First, you are a management team that has not been timid in pursuit of portfolio optimization, whether it's moving out of businesses or adding new products via M&A. How do you feel about the portfolio as it stands today? And is there a desire to round out the portfolio in a way that would give you broader menu similar to other companies in this area?

我想討論兩個話題。首先，你們是一個毫不畏懼追求投資組合優化的管理團隊，無論是退出業務還是透過併購增加新產品。您對目前的投資組合有何看法？您是否希望完善投資組合，以便為貴公司提供與該領域其他公司類似的更廣泛的選擇？

Second, one question we get a lot is how to think about the pipeline value of Veracyte, MRD and nasal swab, especially. How would you respond to those who believe the value assigned to those initiatives are limited?

其次，我們經常被問到的一個問題是如何看待 Veracyte、MRD 和鼻拭子的管道價值。對於那些認為這些措施的價值有限的人，您會如何回應？

Yes. Thanks, Subbu. Appreciate the question. And you're absolutely right. We've been very focused on portfolio management, making sure that the things that we are investing in, have both the appropriate evidence, reimbursement and the launch at the right time.

是的。謝謝，Subbu。感謝你的提問。你說得完全正確。我們一直非常注重投資組合管理，確保我們所投資的項目有適當的證據、報銷，並在正確的時間推出。

And we're not investing in things that don't have the ROI and then adding to our portfolio, for example, by acquiring an MRD asset. If I kind of just remind everybody where we were, I mean, we started out as a company with a single product and a single indication, so Afirma for thyroid, indeterminate thyroid.

我們不會投資那些沒有投資回報率的項目，然後將其添加到我們的投資組合中，例如透過收購 MRD 資產。如果我只是提醒大家我們在哪裡，我的意思是，我們最初是一家只有單一產品和單一適應症的公司，所以 Afirma 適用於甲狀腺，不確定的甲狀腺。

And then we've added not just new products, but also broadened and lengthened the indications that those products cover. For example, in Afirma -- with Afirma, we've added TERT, and we're now working on (inaudible)

我們不僅增加了新產品，還擴大並延長了這些產品涵蓋的適應症。例如，在 Afirma 中，我們添加了 TERT，現在我們正在研究（聽不清楚）

With Decipher, which is an even better example of the expansion, it started out in RP, expanded to biopsy and now is expanding to metastatic. And so, now Decipher covers the entire spectrum of patients with prostate cancer. So I'd say number one is expand within the indication as much as you can, given the leverage.

Decipher 是擴展的一個更好的例子，它從 RP 開始，擴展到活檢，現在正在擴展到轉移性。因此，Decipher 現在涵蓋了所有前列腺癌患者。因此，我想說，首先，在槓桿作用下，盡可能在指示範圍內擴大規模。

Number two is expand the channel. And so you've seen us take our urology channel and expand that with the bladder test and soon to be MRD. And then the third would be indications. And you've heard us talk a lot about adding lung as an indication, which we're very, very significantly working on. And then as we announced today, really adding breast as an indication in the US next year as well.

二是拓展通路。因此，您已經看到我們利用泌尿科渠道，並透過膀胱測試和即將推出的 MRD 來擴展它。第三個是跡象。您可能已經聽到我們多次談論添加肺部作為適應症，我們正在非常非常努力地研究這個問題。正如我們今天宣布的那樣，明年我們也會在美國增加乳癌治療適應症。

And so -- and then taking our MRD platform, and as we mentioned today, expanding the indications there one year -- starting in 2027 after we kind of prove this out with our launch in muscle invasive bladder cancer. So as I think about that portfolio, I think it's incredibly broad with a rich pipeline of new products to come.

然後，我們採用 MRD 平台，正如我們今天提到的那樣，將適應症擴大一年，即從 2027 年開始，屆時我們將透過在肌肉浸潤性膀胱癌領域的推出來證明這一點。因此，當我考慮該產品組合時，我認為它非常廣泛，並且擁有豐富的新產品線。

And I couldn't be more excited about it. Now could we continue to add more menu? Sure. And as you can imagine, we work a lot on things like that, both organically and inorganically. And if there were great opportunities, we would certainly pursue them, which is why we just announced what we're doing in breast, for example.

我對此感到無比興奮。現在我們可以繼續添加更多菜單嗎？當然。正如您所想像的，我們在諸如此類的事情上做了很多工作，既有有機的，也有無機的。如果有很好的機遇，我們一定會抓住，這就是為什麼我們剛剛宣布了我們在乳癌研究方面所做的事情。

To your second part of your question on the pipeline value, I mean, I agree with you. I think the MRD and nasal swab are not much in there today, and we're proving both of those out, and we've got milestones. We've told you what the milestones are in MRD, it's a muscle invasive bladder launch next year, first half in nasal swab is completing the NIGHTINGALE study and ultimately getting that product reimbursed and launched. And those are massive markets. And if you think about it, in both cases, growing from zero in significant markets across multiple indications in the case of MRD.

對於您關於管道價值的問題的第二部分，我的意思是，我同意您的觀點。我認為 MRD 和鼻拭子目前的作用並不大，我們正在證明這兩項檢測是有效的，並且已經取得了里程碑式的進展。我們已經告訴您 MRD 的里程碑，它是明年推出的肌肉侵入性膀胱試驗，鼻拭子試驗的前半部分是完成 NIGHTINGALE 研究，並最終獲得該產品的報銷並推出。這些都是龐大的市場。如果你仔細想想，在這兩種情況下，MRD 都是在多個適應症的重要市場中從零開始成長的。

And so we've got differentiated products in both cases and we've proven our execution capability. So I think investors should look at our track record and evaluate those markets and verify accordingly.

因此，我們在兩種情況下都擁有差異化的產品，並證明了我們的執行能力。因此我認為投資者應該看看我們的業績記錄，評估這些市場並進行相應的驗證。

Yes. And just the only thing to add is, I think historically, those have been longer-dated growth drivers, right? So as we look at where we are today, here in May of '25, we have multiple product launches coming up over the next 12 to 18-month period. And I agree wholeheartedly with Marc on everything he said. The only thing I would add is the time is coming where these things are going to be super exciting and launched, and we'll be able to demonstrate our execution in multiple areas besides just Afirma and Decipher.

是的。唯一需要補充的是，我認為從歷史上看，這些都是長期成長動力，對嗎？因此，當我們回顧現在的情況時，即 2025 年 5 月，我們將在未來 12 到 18 個月內推出多款產品。我完全同意馬克所說的一切。我唯一想補充的是，這些事情即將變得非常令人興奮並推出，我們將能夠在 Afirma 和 Decipher 之外的多個領域展示我們的執行力。

Andrew Brackmann, William Blair.

安德魯布拉克曼、威廉布萊爾。

Maybe actually to pick up on the last question there. You obviously do have these product catalysts and launches over the next coming quarters and years. Maybe just big picture, can you talk about how you're ensuring organizational readiness, both commercially and operationally for these launches? And how do you sort of think about investment into some of the areas that you still need? What are those areas? And how much are you sort of willing to spend?

也許實際上是為了回答最後一個問題。顯然，在接下來的幾個季度和幾年裡，您確實會有這些產品催化劑和產品發布。也許只是從總體上講，您能談談如何確保組織在商業和營運方面為這些發布做好準備嗎？您如何看待對一些仍需投資的領域的投資？這些區域是什麼？您願意花多少錢？

Yes, it's a great question. Our first step is obviously to get these products to market and go through the product development, and we talk about how much we invest in that, as well as generating the evidence which is a key part of our engine, our Veracyte Diagnostics Platform, to make sure that we don't just launch markets on -- products on the market that don't have the evidence to support adoption, reimbursement and ultimately guidelines.

是的，這是一個很好的問題。我們的第一步顯然是將這些產品推向市場並進行產品開發，我們討論了我們在這方面的投資，以及產生證據，這是我們引擎的關鍵部分，即我們的 Veracyte 診斷平台，以確保我們不會在市場上推出沒有證據支持採用、報銷和最終指導方針的產品。

So all of this is coming together. And then it's -- at the end of it, there's obviously a launch plan with the commercial activities all planned out around that. And it's a very thoughtful launch plan. I'll let John discuss a little bit more of it since he's on the call with us today.

所以所有這些都匯集在一起了。然後——最後，顯然有一個發布計劃，所有商業活動都圍繞著它進行規劃。這是一個非常周到的發布計劃。由於約翰今天與我們通話，所以我請他進一步討論這個問題。

But we make sure that we don't invest ahead of the opportunity growing. So we add -- and you saw us do this with Decipher and Afirma, we add sales teams and commercial capabilities as we need it, as we grow. John, do you want to share a little bit more?

但我們確保不會在機會出現之前進行投資。因此，我們增加了——正如您看到我們透過 Decipher 和 Afirma 所做的那樣，隨著我們的發展，我們會根據需要增加銷售團隊和商業能力。約翰，你想分享更多嗎？

Yes. Thanks, Marc. I'll add to that just by saying you'll see that there's been great thoughtfulness in how we think about the analytical platform first. We mentioned today version two of our transcriptome. That's the underpinning of a variety of products that we're developing and launching.

是的。謝謝，馬克。我還要補充一點，您會發現，我們首先對分析平台的思考已經非常周到。我們今天提到了轉錄組的​​第二個版本。這是我們正在開發和推出的各種產品的基礎。

Number two, with C2i acquisition, we mentioned from the very beginning, we really saw that as a platform play from which we could gain leverage and launch new indications rather quickly. So it all starts in the lab. And then from there, I would say channel synergies are what we look at very, very carefully. With muscle invasive bladder cancer, one of the selection criteria for that was -- that serves the market where we have leadership. We have very strong relationships with those ordering physicians.

第二，我們從一開始就提到，對於 C2i 的收購，我們確實將其視為一個平台，我們可以從中獲得優勢並相當快地推出新的適應症。一切都是從實驗室開始的。然後從那時起，我想說通路綜效是我們非常非常仔細地考慮的。對於肌肉層浸潤性膀胱癌，選擇標準之一是－服務我們處於領先地位的市場。我們與那些開處方的醫生保持著非常密切的關係。

And then beyond that, we're being very thoughtful and considerate as we add new channels, as would be the case with Prosigna and the LDT test here in the US. We'll do that in a very measured way, not taking on a big investment upfront, but looking to scale that over time as we see proportionate revenues.

除此之外，我們在新增管道時也非常周到和考慮周到，就像美國的 Prosigna 和 LDT 測試一樣。我們會以非常慎重的方式來實現這一目標，不會在前期進行大筆投資，而是隨著收入的增加而逐步擴大投資規模。

And just on the investment front, perhaps, Andrew. As both Marc and John mentioned, obviously, the lab is a critical cornerstone of us being able from an organizational perspective to be ready here. And I think we've previously mentioned, I know it's in our filings that we have renewed the lease for both San Diego and San Francisco and are in the process of building out capacity in both locations that allow us to operate for the next five to seven years. And so, from that standpoint, the lab is ready to go for all of these things once they're finalized in development. And obviously, both -- John and Marc both cited that we parse into these commercial channels if they're net new.

安德魯，也許只是在投資方面。正如馬克和約翰所提到的，顯然，從組織角度來看，實驗室是我們可以準備的關鍵基石。我想我們之前提到過，我知道在我們的文件中，我們已經續約了聖地牙哥和舊金山的租約，並且正在這兩個地方建立產能，以便我們能夠在未來五到七年內運作。因此，從這個角度來看，一旦這些事情的開發完成，實驗室就準備好進行所有這些工作。顯然，約翰和馬克都提到，如果這些是全新的，我們就會將其解析到這些商業管道中。

We will have some incremental investment on the R&D front to get all of these to market over the next 18 months. That being said, we also are obviously always looking at our financial profile and ensuring that it is delivering upon what we have shared with you all. So in any given year, things can swing a little bit one way or the other.

我們將在研發方面進行一些增量投資，以便在未來 18 個月內將所有這些產品推向市場。話雖如此，我們顯然也始終關注我們的財務狀況，並確保其能夠兌現我們與大家分享的內容。因此，在任何一年中，情況都可能會發生一些變化。

As we look for the next 18 months, though, obviously, we're expanding our adjusted EBITDA margin guidance today and that's a great -- it's going in the right direction. And obviously, we think about balancing all these things as we structure our P&L in any given year.

然而，當我們展望未來 18 個月時，顯然，我們今天正在擴大調整後的 EBITDA 利潤率指引，這是一件好事——它正朝著正確的方向發展。顯然，我們在建立任何一年的損益表時都會考慮平衡所有這些因素。

That's great color. And then maybe just on Decipher today, Marc, I think you called out a 20% increase in the ordering physician base in the quarter. Can you maybe just tell us a little bit more about that 20% increase? Who are those doctors that sort of came on board? Are they sort of competitive wins, or are they new to testing in sort of general?

顏色真棒。然後也許就在今天的 Decipher 節目中，Marc，我想您提到本季度的開立處方的醫生數量增加了 20%。您能否向我們詳細介紹一下 20% 的成長情況？那些前來幫忙的醫生是誰？他們是在競爭中獲勝，還是在整體上對測試還很陌生？

And then as you sort of think about the potential for additional doctors to come on board, where are we in terms of penetration into the overall ordering base that you see?

然後，當您考慮是否有可能吸引更多醫生加入時，您認為我們在整體訂購基礎方面的滲透率處於什麼水平？

Yes. Thanks, Andrew. The commercial execution this quarter in Decipher has been yet again exceptional, setting new records. And John leads that organization. I'm going to ask John to share a little bit about the makeup of that 20% growth.

是的。謝謝，安德魯。Decipher 本季的商業執行再次表現出色，創下了新的紀錄。約翰領導該組織。我將請約翰分享這 20% 成長的組成。

Yes. It's a bit of a mixed bag, Andrew. Thanks for the question. We're constantly running initiatives within our commercial strategy that focus on new physicians that are new to the test or they're formerly ordered -- ordering physicians that for some reason or another have kind of fallen off, that are familiar with the test, but maybe their ordering rate has fallen off, and we've reactivated them. And we see great gains there.

是的。這有點混亂，安德魯。謝謝你的提問。我們在商業策略中不斷推出舉措，重點關注那些剛接觸這項測試的新醫生，或者那些以前曾接受過測試的醫生——那些由於某種原因而放棄測試的醫生，他們熟悉這項測試，但可能他們的測試頻率已經下降，我們重新激活了他們。我們在那裡看到了巨大的進步。

Some are entirely new to the business and have never ordered a genomic test before. So that would be pure penetration into the space. And then as you alluded, a good number are market share gains.

有些人對這個行業完全陌生，之前從未訂購過基因組測試。所以這將是對空間的純粹滲透。然後，正如您所提到的，相當一部分市場份額都有所增長。

And on the penetration from an ordering perspective, I think the key there is, obviously, we're penetrating the larger accounts. And there's always going to be a long tail of smaller accounts, but the penetration into the physician base, which is an extremely difficult number to measure actually in terms of who are the actual ordering physicians. But the penetration is very strong.

從訂購角度來看，就滲透率而言，我認為關鍵顯然是我們正在滲透更大的帳戶。並且總是會存在大量較小的帳戶，但對於醫生群體的滲透率，就實際開立處方的醫生而言，實際上是一個極其難以衡量的數字。但穿透力非常強。

Obviously, given that long tail as a percentage, you'd expect it to be a little smaller than our overall penetration, which is -- and I'll remind everybody, again, about -- market about 40% penetrated and Decipher about 65% share, but still very strong.

顯然，考慮到長尾的百分比，你會認為它會比我們的整體滲透率略小，我再次提醒大家，市場滲透率約為 40%，Decipher 的份額約為 65%，但仍然非常強勁。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

So maybe first on the guide. I just wanted to clarify the moving parts there. In terms of the number you delivered, I mean you came in, I think, $4 million ahead of the Street, but you're not raising your guide. There's Envisia, some impact in there. There is some of that.

因此也許首先要介紹的是指南。我只是想澄清一下其中的活動部分。就您交付的數字而言，我的意思是，我認為您比華爾街領先了 400 萬美元，但您不會提高您的指導金額。有 Envisia，它有一定的影響。有一部分是這樣的。

There is impact maybe from Marseille and the biopharma is getting pulled out. So can you maybe walk us through those? And then beyond that, how are you -- how should we expect the Afirma growth? It looks like it's been low single-digit growth. Is that the right way to think about Afirma and then Decipher as well within the context of the guide?

馬賽可能會產生影響，生物製藥業將被撤出。那可以向我們詳細介紹一下這些嗎？除此之外，您認為我們應該如何期待 Afirma 的成長？看起來這是一個低個位數的成長。這是在指南的背景下思考 Afirma 和 Decipher 的正確方法嗎？

Yes, I'm happy to take that one, Puneet. So I just want to be very careful here. We're talking apples-to-apples and oranges-to-oranges. So the first thing on the guide is recall the test -- the guide is $470 million to $480 million for testing only. And everything we've looked at that the guide and -- I'm sorry, the Q1 results were right on top of Street estimates for testing.

是的，我很樂意接受這個，Puneet。所以我只是想在這裡非常小心。我們討論的是同類問題，也是橘子與橘子之間的問題。因此，指南中的第一件事是回憶測試——指南中僅用於測試的費用就為 4.7 億至 4.8 億美元。我們所看到的指南中的所有內容——抱歉，第一季的結果正好高於華爾街對測試的估計。

And so where the beat came from was primarily biopharma and product, which are not -- we don't have a total company guide right now because we don't have definitive clarity on the timing of the Marseille operation, which then impacts the total revenue, if that all makes sense. I'm going to pause there and just make sure do you have any follow-ups on that before I move to Afirma?

因此，業績主要來自生物製藥和產品，而這些不是——我們目前沒有完整的公司指南，因為我們對馬賽運營的時間沒有明確的定義，這會影響總收入，如果這一切都說得通的話。我要在這裡暫停一下，只是想確保在我轉到 Afirma 之前您是否有任何後續行動？

Yes. No, that's helpful, yes. And Afirma?

是的。不，是的，這很有幫助。還有 Afirma 嗎？

Okay. Great. For Afirma, we delivered 10% volume growth, 6% revenue growth. About two-thirds of the delta between the two is tied to prior period collection in the prior year, a third was tied to the LBM impact that Marc mentioned. So 6% revenue growth in Q1.

好的。偉大的。對 Afirma 而言，我們的銷量成長了 10%，營收成長了 6%。兩者之間的差異約有三分之二與前一年同期的收款有關，三分之一與馬克提到的 LBM 影響有關。因此第一季營收成長6%。

We are still contemplating high single-digit revenue growth for the year. I think you might be looking at it with cytology, which we have said on the last call, cytology typically is pretty flat. So we don't think about cytology in the same way. Cytology is a mechanism of getting samples, not necessarily a growth driver for us. So we think -- when we think about Afirma, we're giving just the Afirma number, not including cytology.

我們仍然預計今年的收入將實現高個位數成長。我認為您可能正在用細胞學方法觀察它，我們在上次通話中說過，細胞學通常非常平坦。因此，我們對細胞學的思考方式不同。細胞學是一種獲取樣本的機制，不一定是我們的成長動力。所以我們認為——當我們考慮 Afirma 時，我們只給出 Afirma 數字，不包括細胞學。

Got it. Okay. That's helpful. And then on the Marseille side, can you just -- you talked about gross margin impact because of the fixed costs. But can you just clarify what -- how should we think about that?

知道了。好的。這很有幫助。然後就馬賽方面而言，您能否談談固定成本對毛利率的影響。但是您能否澄清一下—我們應該如何看待這個問題？

Was there an OpEx impact as you continue to run this facility into 2025? And then, what are the scenarios there? Could this -- is there a scenario in which it could take longer than the year-end of '25?

如果您繼續營運該設施至 2025 年，是否會產生營運支出影響？那麼，那裡的情況是怎麼樣的呢？有沒有可能——存在一種情況，需要的時間會比 25 年底更長？

Yes. I'm happy to take that and can have Marc opine. Yes, we had our typical run rate of OpEx in Marseille. We said with revenue, that was about a $20 million loss on an annualized basis. And so you can think about the quarterly impact of that as expected.

是的。我很高興接受這個建議，並且可以讓馬克發表意見。是的，我們在馬賽的營運支出有典型的運行率。我們說，如果算上收入，那麼以年率計算，損失大約是 2,000 萬美元。因此，您可以考慮其預期的季度影響。

Obviously, it was slightly less given the gross profit outperformance, but you're close enough if you just take that impact. And then with regard to the process itself, we have confidence that we will be done by the end of this year.

顯然，考慮到毛利的優異表現，這個數字會稍微少一些，但如果只考慮這個影響，那就夠接近了。至於流程本身，我們有信心在今年年底前完成。

Obviously, these things could take longer. I wouldn't say that's a 0% probability, but our -- all of our expectations, all of our advisers' expectations is that we are done with this by the end of the year. And we had an important step today with the court accepting the application for bankruptcy. So everything seems to be tracking as planned.

顯然，這些事情可能需要更長的時間。我不會說這個機率是 0%，但是我們所有人的期望、我們所有顧問的期望都是我們能在年底前完成這件事。今天我們踏出了重要的一步，法院受理了破產申請。一切似乎都按計劃進行。

Yes. And don't forget there's some -- also, if you think about it, Puneet, there's some onetime costs associated with this as well that we talked about last quarter and our estimates around that similar of $15 million.

是的。別忘了還有一些——此外，如果你仔細想想，Puneet，這其中還涉及一些一次性成本，我們上個季度討論過，我們的估計大約是 1500 萬美元。

And that's a cash number. There'll be non-cash impacts as well. Thanks for that reminder, Marc.

這是一個現金數字。也會產生非現金影響。謝謝你的提醒，馬克。

Yes.

是的。

Okay. And then if I could just ask one last one on Prosigna. You're launching that in the U.S. I just want to understand, is there something differentiating about the test? Because it is launching in a market that is well penetrated.

好的。然後我可以問最後一個關於 Prosigna 的問題嗎？你們在美國推出了這項測試。我只是想了解一下，這項測驗有什麼不同嗎？因為它是在一個滲透率較高的市場推出的。

Oncotype DX has been in the breast market, well established for a long time. You've got MammaPrint there, too. So just trying to understand how are you thinking about the U.S. market and the growth expectation for Prosigna?

Oncotype DX 已在乳腺市場上存在很長時間，並且已確立地位。您那裡也有 MammaPrint。所以只是想了解您如何看待美國市場以及對 Prosigna 的成長預期？

Yes. Thanks, Puneet. We actually -- yes, we do believe that the test is differentiated. I mean, as we always do, we base our business models on evidence generation. And we alluded to the fact that we're expecting some data that supports the use of the test for clinical utility and the differentiation of the test.

是的。謝謝，Puneet。是的，我們確實相信測試是有區別的。我的意思是，正如我們一貫的做法，我們的商業模式以證據生成為基礎。我們提到，我們期待一些數據來支持該測試的臨床應用和測試的區分。

And so now it's the right time for us to launch that into what you correctly state is a penetrated market, starting from zero -- effectively zero for us in the US and gaining some share there. John, do you want to add anything?

因此，現在是我們將其推向您正確指出的滲透市場的最佳時機，從零開始——實際上我們在美國是零，並在那裡獲得一些份額。約翰，你還有什麼要補充嗎？

Yes. It's obviously something that took a good bit of consideration from us. In Europe, it is a test that has gained some traction, especially amongst the key opinion leaders, is in fact, those thought leaders who've been driving much of the more recent evidence. It is on the backbone of that evidence that we are looking to gain share within the US with our LDT test.

是的。顯然，這是我們經過深思熟慮的事情。在歐洲，這項測試已經獲得了一些關注，特別是在關鍵意見領袖中，事實上，這些思想領袖一直在推動最新的證據。正是基於這項證據，我們希望透過 LDT 測試在美國獲得市場份額。

So evidence is one layer of differentiation. The second is the playbook. It's not entirely unlike how we ran Decipher. Decipher was also a late entrant into the space. And based on our product design, based on our philosophy towards evidence development and collaboration with key opinion leaders, based on our commitment towards evidence generation and guideline inclusion, Decipher has come up very quickly in terms of market leadership.

因此，證據是區分的一個層次。第二個是劇本。這與我們運行 Decipher 的方式並不完全一樣。Decipher 也是該領域的後來者。基於我們的產品設計、基於我們對證據開發和與關鍵意見領袖合作的理念、基於我們對證據生成和指南納入的承諾，Decipher 在市場領導地位方面迅速崛起。

That's what we're hoping to rerun with Prosigna as well.

這也是我們希望與 Prosigna 一起重現的。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Colleen on for Doug. We just have a question on the Decipher ramp for the balance of the year. It looks like ASPs came in around $2,950 in Q1. And our understanding is that the metastatic test will have similar ASPs as the biopsy-based test. And with that in mind, should we keep ASPs flat throughout the balance of the year? And how should we be thinking about the volume growth trajectory this year and into 2026?

科琳替換道格上場。我們只是對今年餘下的 Decipher 進程有一個疑問。看起來第一季的平均售價約為 2,950 美元。我們的理解是，轉移性測試將具有與基於活檢的測試相似的 ASP。考慮到這一點，我們是否應該在全年保持平均銷售價格穩定？我們該如何看待今年和 2026 年的銷售成長軌跡？

Yes, Colleen, I'm happy to take that. Recall, slightly more of the population for metastatic is Medicare. And therefore, the ASP, I would think is very slightly higher, but not materially so. But on the counter side to that, we will not necessarily have coverage or contracting for the non-Medicare population. And so those two things probably net out.

是的，科琳，我很樂意接受。回想一下，在轉移性癌症的人口中，享有醫療保險的人數略多。因此，我認為 ASP 會略高一些，但不會實質地高。但與此相反，我們不一定會為非醫療保險人群提供保險或簽約。因此，這兩件事可能會互相抵消。

I would love to be able to give you more details behind that. But in all honesty, it is a quarter-by-quarter play depending on mix. So I think having around the same ASP maybe drifting up very, very slightly over the rest of the year is reasonable. But from a growth rate perspective, our full year guide implies 19% to 22% revenue growth. Volumes, we are -- as we saw in the first quarter, experiencing a prior period collection headwind on a -- versus the prior year.

我很樂意為您提供更多有關此問題的詳細資訊。但老實說，這是一個根據組合逐季度進行的遊戲。因此我認為，在今年剩餘時間內，平均售價保持大致相同，可能略有上漲，這是合理的。但從成長率的角度來看，我們的全年指引意味著營收成長 19% 至 22%。從銷售來看，正如我們在第一季看到的那樣，與去年相比，我們經歷了前期的收款逆風。

And so as we think about the rest of the year, we are contemplating that the comps get harder for volume, but obviously, we have great expectations for the Decipher franchise for the rest of this year and into perpetuity, especially given the nascency of the market at 40% penetrated. We have 65% share. We just grew volume 37% this quarter. We've seen some other numbers out there that are less than 37% for our competitors.

因此，當我們考慮今年剩餘時間的表現時，我們認為銷量的比較會變得更加困難，但顯然，我們對 Decipher 系列在今年剩餘時間以及未來幾年的表現抱有很大的期望，特別是考慮到市場滲透率僅為 40% 的新興市場。我們擁有65%的份額。本季我們的銷量成長了 37%。我們看到其他一些數字表明我們的競爭對手的比例低於 37%。

And so I think we're well on our way to continuing to deliver really strong growth from the Decipher franchise, thereby bridging the gap into our other growth drivers that are now very much on the come in the next couple of -- a year or two.

因此，我認為我們正順利地繼續透過 Decipher 系列實現真正強勁的成長，從而彌補我們與其他成長動力之間的差距，這些成長動力將在未來一兩年內迅速崛起。

All right. And then we just have one follow-up on MRD. So can you help us better understand how the data shared from TOMBOLA positions your test as differentiated in bladder relative to currently marketed assays? And also, given higher COGS associated with sequencing the whole genome at every time point, what optionality do you have on sequencing to ensure that your MRD test isn't meaningfully margin dilutive at launch?

好的。然後我們只需對 MRD 進行一次跟進。那麼，您能否幫助我們更好地理解 TOMBOLA 共享的數據如何使您的測試在膀胱方面與目前市場上的檢測方法有所差異？此外，考慮到在每個時間點對整個基因組進行定序所帶來的 COGS 較高，您在定序方面有哪些可選性，以確保您的 MRD 測試在發佈時不會顯著稀釋利潤？

And then finally, I believe in the prepared remarks that Marc indicated that you submitted your tech assessment to MolDx last month or in March rather. Should we assume that you'll have reimbursement at the time of launch?

最後，我相信馬克在準備好的評論中表示，您上個月或三月向 MolDx 提交了您的技術評估。我們是否應該假設您會在發佈時獲得報銷？

Yes. So let's cover each of those, and Rebecca and John, feel free to jump in here. But TOMBOLA differentiated the test relative to ddPCR and compared the performance of the whole genome approach. And if you actually look at that publication or that presentation, you see how the investigators tackle that. If you think about relative to other tests on the market and how to penetrate the MRD market, we have consistently maintained that the most important measure is how much sooner than imaging, which is the standard of care, you are detecting recurrence.

是的。因此，讓我們來介紹一下這些內容，麗貝卡和約翰，請隨意加入。但 TOMBOLA 將該測試與 ddPCR 區分開來，並比較了全基因組方法的性能。如果你真的看一下那份出版物或那份簡報，你會看到研究人員是如何解決這個問題的。如果您考慮相對於市場上的其他測試以及如何滲透 MRD 市場，我們始終認為最重要的衡量標準是比影像（即護理標準）更快地檢測到復發。

And so in this particular case, TOMBOLA, it reinforced data that we've already presented and published in MRD, which is -- in this case, it was 93 days, which is a great lead time. And so that -- and then, of course, the whole genome approach is what we really believe every step of the way is differentiating.

因此，在這個特殊的案例中，TOMBOLA 強化了我們已經在 MRD 中呈現和發布的數據，在這個案例中，它是 93 天，這是一個很好的準備時間。所以 — — 當然，我們確實相信全基因組方法的每一步都是有區別的。

And it goes to our underlying philosophy. I'll come to the kind of last further part of your question and let Rebecca come back to the COGS impact of that. But -- it is -- if you think about Decipher and how we've approached that, I said before, we could have run a 22-gene assay for every single test, and we would not have close to 100 publications supporting the use of Decipher if we had done that.

這符合我們的基本理念。我將回答您問題的最後一個部分，讓麗貝卡再來談談這個問題對 COGS 的影響。但是 — — 它是 — — 如果你考慮一下 Decipher 以及我們是如何處理這個問題的，我之前說過，我們可以對每個測試進行 22 個基因的檢測，如果我們這樣做的話，我們不會有近 100 篇出版物支持使用 Decipher。

It is the ability to have all that rich data. So as long as we can make sure, to your point, we can manage the COGS of that and the margin of that, it is a very worthwhile investment in creating the richness of that data for every single sample and the ability to use that in the future to advance our test into other indications and into tumor naive and what else.

它是擁有所有豐富數據的能力。因此，只要我們能夠確保，正如您所說，我們可以管理其成本和利潤，那麼為每個樣本創建豐富的數據，並能夠在未來使用這些數據將我們的測試推進到其他適應症、腫瘤幼稚等方面，這是一項非常值得的投資。

I mean, there are things we could do with it that we can't even contemplate today. But it's hard to imagine a world where 5 to 10 years from now everybody is not talking about the richness of whole genome data in this space. Do you want talk about that?

我的意思是，我們可以用它做一些我們今天甚至無法想像的事情。但很難想像 5 到 10 年後的世界不再有人談論這個領域全基因組資料的豐富性。你想談論這個嗎？

Yes, of course. And on the COGS side of the equation, in muscle invasive bladder cancer, we absolutely are excited about that indication because approximately 85% of that population is Medicare. And therefore, from an ASP perspective, it should be a relatively nice ASP out of the gate.

是的當然。從等式的 COGS 方面來看，對於肌肉浸潤性膀胱癌，我們對這個適應症感到非常興奮，因為大約 85% 的人口都享有醫療保險。因此，從 ASP 的角度來看，它應該是一個相對較好的 ASP。

We have multiple projects ongoing on the COGS reduction front for MRD, just similar to those that we talked about today with regard to Afirma. And so over a multiyear period, we have a lot of confidence in our ability to drive down sequencing costs as well as, obviously, there are many different sequencing platforms that are currently at play, that may or may not be influencing our cost down road map.

我們在 MRD 的 COGS 削減方面有多個正在進行的項目，與我們今天談到的 Afirma 相關的項目類似。因此，在多年的時間裡，我們對降低定序成本的能力充滿信心，而且顯然，目前正在發揮作用的許多不同的定序平台可能會或可能不會影響我們的成本路線圖。

So we're excited about the potential for having a very data-rich MRD platform with cost that is more expensive admittedly, but similar to the reasons that Marc cited from the Decipher standpoint. We think that's a worthwhile trade.

因此，我們對擁有一個數據非常豐富的 MRD 平台的潛力感到非常興奮，儘管其成本更高，但與 Marc 從 Decipher 的角度提出的原因類似。我們認為這是一筆值得的交易。

We're really focused on making sure that on an adjusted EBITDA basis, this is a product and a project and a platform. I couldn't get the right keyword out, sorry, a platform that is able to be accretive to our adjusted EBITDA over a multiyear period. And so I think that's kind of the way we're thinking about it more so than on a gross margin basis.

我們真正專注於確保在調整後的 EBITDA 基礎上，這是一個產品、一個專案和一個平台。抱歉，我找不到正確的關鍵字，一個能夠在多年內增加我們調整後 EBITDA 的平台。所以我認為這是我們思考這個問題的方式，而不是基於毛利率。

And the last point that I'll add in there is similar to Decipher, we have higher COGS, but we have lower R&D spend in terms of the clinical utility. So all-in-all, we're very comfortable with the path forward, excited about it. And yes, we will be launching with reimbursement.

我要補充的最後一點與 Decipher 類似，我們的 COGS 更高，但就臨床實用性而言，我們的研發支出較低。總而言之，我們對未來的道路感到非常滿意，並對此感到興奮。是的，我們將推出報銷服務。

Tejas Savant, Morgan Stanley.

摩根士丹利的 Tejas Savant。

Just one quick cleanup for you, Rebecca, on the guide. I think you called out sort of mitigating tariffs as one of the rationales for your v2 transcriptome switch for Afirma. Is that a meaningful dynamic for you, or is this just really you guys expecting your vendors, including your sequencing vendor to likely add tariffs or surcharges here shortly?

麗貝卡，我們只需對指南進行一次快速清理。我認為您提出的減輕關稅是 Afirma 進行 v2 轉錄組轉換的理由之一。這對您來說是一個有意義的動態嗎？或者這只是你們真正期望您的供應商（包括您的測序供應商）可能很快在這裡增加關稅或附加費？

Yes, I'm going to actually have that one -- hand that one over to Marc.

是的，我確實要把那個交給馬克。

Yes. Actually, Tejas, we were working on this as part of our lab optimization process, as you would expect us to, for a long time. And the point around tariffs was the fact that we're doing this helps us mitigate, or should help us mitigate the impact of the tariffs to some extent. And there's a lot of uncertainty around that. None of us knows how impactful this is all going to be.

是的。實際上，正如您所期望的那樣，我們長期以來一直在將此作為實驗室優化過程的一部分進行研究。關於關稅的重點是，我們這樣做有助於我們減輕，或應該在一定程度上幫助我們減輕關稅的影響。這方面存在著許多不確定性。我們誰也不知道這一切將會產生多大的影響。

But as we've always done, we're very focused on COGS to mitigate whatever the supply chain risks are, whether it be tariffs or just price increases. At the same time, as Rebecca mentioned earlier, we expect price decreases on certain agents as well. So as we've always said, we don't really see first or second order -- we don't really see first order effects for us, but we do get second and third order effects. Our supply chain is impacted by tariffs. And in fact, we've already had one vendor talk about raising surcharges on us as well in the future.

但正如我們一直以來所做的那樣，我們非常注重 COGS，以減輕供應鏈風險，無論是關稅還是價格上漲。同時，正如 Rebecca 之前提到的，我們預期某些代理商的價格也會下降。因此，正如我們一直所說的那樣，我們實際上看不到一階或二階——我們實際上看不到一階效應，但我們確實看到了二階和三階效應。我們的供應鏈受到關稅的影響。事實上，已經有一家供應商表示將來也會提高我們的附加費。

And that's something that we've contemplated in the guide that we've given here. So we're managing to that. But it's -- there's some uncertainty around that, and we'll continue to track it. But we'll respond accordingly as we always do. And we've got a lot of irons in the fire to make sure we're able to continue to drive positive gross margin and EBITDA in the future.

這是我們在此提供的指南中考慮到的事情。我們正在努力實現這一目標。但這方面存在一些不確定性，我們會繼續追蹤。但我們會像往常一樣做出相應的回應。我們還有很多事情要做，以確保未來能夠繼續實現正的毛利率和 EBITDA。

Got it. And then a couple of quick follow-ups on the MRD side, Marc, if I may. First of all, I mean, on the TOMBOLA results that you guys have shown at AACR and even earlier this year, I guess my question is the investigator found that ddPCR was more sensitive, but your assay was more specific. So are you guys exploring any opportunities to further boost sensitivity or you don't think you really need that? And then second, what sort of data should we expect to see at ASCO shortly here?

知道了。然後，如果可以的話，馬克，我想快速跟進 MRD 方面的一些問題。首先，我的意思是，根據你們在 AACR 甚至今年早些時候展示的 TOMBOLA 結果，我想我的問題是研究人員發現 ddPCR 更敏感，但你們的檢測更具體。那麼，你們是否正在探索進一步提高敏感度的機會，或者你們認為你們並不真的需要這樣做？其次，我們應該期待在 ASCO 上看到什麼樣的數據？

Yes. So I mean -- I'd just go back to my previous comment on MRD. If you look at any single measure, whether it be sensitively, specificity, limited detection, you're missing the broader picture, right? The broader picture is how much sooner can you pick up the detection and standard of care? And you could tune any one of those other metrics with the detriment of another metric.

是的。所以我的意思是——我只是想回到我之前對 MRD 的評論。如果您只看任何單一指標，無論是敏感性、特異性還是有限檢測，您都會忽略更廣泛的情況，對嗎？更廣泛的情況是，您多久可以掌握檢測和護理標準？你可以調整其中任何一個指標，但會損害另一個指標。

And if it doesn't help the lead time to detection, then you're going in the wrong direction. So we look at it as a collection of these factors and studies that show that the test is effective in [picking up] detection early. And so that's one of the metrics that came out of the study that we really like. What should we see in terms of ASCO -- anything, John, you want to refer to on that? No, nothing?

如果它無助於縮短偵測時間，那麼你就走錯方向了。因此，我們將其視為這些因素和研究的集合，表明該測試對於早期發現是有效的。這是我們真正喜歡的研究得出的指標之一。就 ASCO 而言，我們應該看到什麼——約翰，您想參考什麼嗎？沒有，沒有？

Nothing that we're expecting at this point. I don't think we're expecting anything on MRD in particular from our side.

目前我們還沒有任何期待。我認為我們對 MRD 不抱有任何特別的期望。

So we'll keep you posted, and we'll give you our perspective on things that do come out.

因此，我們會隨時向您通報最新情況，並就所發生的事情發表我們的看法。

Got it. And then one last one here for me on the Decipher side of things, Marc. You flagged your digital pathology efforts. Could you just share some color on this view that there is a decent amount of physicians out there who value the complementary data provided by a combo approach?

知道了。然後，關於 Decipher 方面，我還有最後一個問題要問，馬克。您標記了您的數位病理學努力。您能否解釋一下這個觀點：有相當多的醫師重視組合療法所提供的補充資料？

We're hearing some of that from one of your competitors recently and they're planning to launch their version of the combo test in -- I guess, by year-end this year. So curious as to how you're thinking about the time lines to market here and how big the opportunity might be for a value proposition like that?

我們最近從你們的一個競爭對手那裡聽說了一些這方面的消息，他們計劃在今年年底推出他們自己的組合測試版本。我很好奇您如何看待這裡的上市時間表以及這樣的價值主張的機會有多大？

Yes. I think if you ask physicians -- and of course, you can imagine that we have, and I'm sure others have to. If you ask physicians, then, of course, the more data, the better. And they don't tend to take one data set and take it at the substitution of another data set. More data is better.

是的。我想如果你問醫生——當然，你可以想像我們有，而且我相信其他人也一定有。如果你問醫生，那當然數據越多越好。他們不會傾向於用一個資料集來取代另一個資料集。數據越多越好。

And so of course, if they could have complementary data that enhance the information they have, then they would say, yes, we'd love to have that. The question that we're still trying to answer is, is the data set complementary? We think it can be complementary, but it can also be contradictory and that can cause confusion in the space.

因此，當然，如果他們能夠獲得補充數據來增強他們所掌握的信息，那麼他們會說，是的，我們很樂意擁有它。我們仍在嘗試回答的問題是，資料集是否互補？我們認為它們可以是互補的，但也可以是矛盾的，並且可能導致空間混亂。

Now if you need to add a digital pathology approach in order to bolster an existing molecular diagnostic test to make it perform better, then that's one way to do it. But as we've always said, Decipher has so much evidence behind it, performs really well across the entire spectrum that we don't see that, that necessarily is needed to enhance Decipher.

現在，如果您需要添加數位病理學方法來增強現有的分子診斷測試，使其表現得更好，那麼這是一種方法。但正如我們一直所說的那樣，Decipher 背後有如此多的證據，在整個範圍內表現非常出色，我們沒有看到這一點，這必然是增強 Decipher 所必需的。

If there's a market opportunity for that, then given that we've scanned 70,000 images with -- across 40,000 patients with outcomes, plus we have whole transcriptome for every single one of those, you can imagine that we could make that information available. And we're actually -- we have made it available for collaborators today.

如果有這樣的市場機會，那麼考慮到我們已經掃描了 40,000 名患者的 70,000 張圖像，並且擁有每一位患者的完整轉錄組，你可以想像我們可以提供這些資訊。事實上，我們今天已經將其提供給合作者。

So the research -- this is interesting from a research perspective. We don't see the commercial opportunity yet, but we're continuing to drive the research. And if there is a commercial opportunity, then you can imagine we'd jump on that.

因此，從研究角度來看，這項研究很有趣。我們尚未看到商業機會，但我們正在繼續推動研究。如果有商業機會，你可以想像我們會抓住它。

Thomas DeBourcy, Nephron Research.

德布爾西 (Thomas DeBourcy)，腎元研究。

So a question on Decipher related to, I guess, your ability to expand coverage now with, I guess, Level 1, I guess, being in NCCN guidelines relative to other tests. Have you seen, I guess, an expansion of coverage over kind of the last several quarters? And have payers maybe changed also their position on some of the other tests as well that maybe also help share gain?

所以關於 Decipher 的一個問題，我猜，您現在是否有能力擴大覆蓋範圍，我猜，1 級，相對於其他測試，符合 NCCN 指南。我想，您是否看到過去幾季覆蓋範圍有所擴大？付款人是否也改變了對其他一些測試的立場，這也許也有助於提高市場佔有率？

Yes. John will answer that.

是的。約翰會回答這個問題。

Thanks for the question, Thomas. Yes, this is obviously an ongoing set of activities here being managed by my team. We are constantly engaging with payers, whether they be government, private or otherwise. We do see traction in our discussions and very active engagement with payers, with the coverage setters, with the lab benefit managers. We are in an active exchange of the latest evidence as well as the latest guidelines.

謝謝你的提問，托馬斯。是的，這顯然是我的團隊正在管理的一系列持續活動。我們不斷與付款人接觸，無論他們是政府、私人或其他。我們確實看到了與付款人、承保範圍制定者、實驗室福利管理人員的討論和非常積極的互動。我們正在積極交流最新的證據以及最新的指南。

As you can imagine, these are generally long-term conversations that coincide with an annual review of the evidence. And so when we believe we're closer to gaining traction or when we believe that a release on coverage policies is looking to expand, we'll be sure to note those.

你可以想像，這些通常是長期對話，與每年的證據審查相吻合。因此，當我們相信我們即將獲得支持或當我們相信覆蓋範圍政策的發布正在擴大時，我們一定會注意到這些。

And Tom, one thing I would add, obviously, having a conversation with payers and showing the Level 1 guidelines, the NCCN guidelines with the Level 1 evidence that we have really helps bolster that conversation. Now it doesn't get you over the line in every case. It's really hard sometimes, but it certainly helps.

湯姆，我想補充一點，顯然，與付款人進行對話並展示 1 級指南、NCCN 指南以及我們擁有的 1 級證據確實有助於加強這一對話。現在它不會讓你在每種情況下都達到要求。有時這確實很難，但確實有幫助。

And just maybe just a follow-up question on, I guess, the slide talking about 2026 to 2028 targets and I guess, profitability target still about 25% of adjusted EBITDA. And so, just in the context of new product launches, would you also kind of be considering your spending relative to, I guess, targeting that 25% adjusted EBITDA goal?

我想這也許只是一個後續問題，投影片上談到了 2026 年至 2028 年的目標，我猜獲利目標仍然約為調整後 EBITDA 的 25%。那麼，僅在新產品發布的背景下，您是否也會考慮相對於 25% 調整後 EBITDA 目標的支出？

Yes. The goal absolutely takes into account what we believe will need to be spent over the next period of time to launch all of those products. We have shown an ability to do things much more efficiently than others in the space and a revenue per headcount basis using that as one metric. And I don't expect our new product launches to be any different. We will be building a med onc channel for Prosigna.

是的。這個目標絕對考慮到了我們認為在未來一段時間內推出所有這些產品所需花費的資金。我們已經證明，我們能夠比該領域的其他人更有效率地完成工作，並以此為衡量標準來計算人均收入。我並不認為我們推出的新產品會有什麼不同。我們將為 Prosigna 建立一個醫學腫瘤學頻道。

It will take multiple quarters and years to really get to the point where it's at scale, similarly to how we're investing in Decipher and Afirma. We put a handful of heads in that in any given period. And so we'll be able to meter that in, in a way that's tied to revenue growth, and we're super excited about our ability to continue to drive a differentiated profitability profile and do all of these things at the same time.

要真正達到規模化程度需要多個季度甚至數年的時間，就像我們對 Decipher 和 Afirma 的投資一樣。在任何特定時期，我們都投入了大量人力。因此，我們將能夠以與收入成長掛鉤的方式對其進行衡量，並且我們對繼續推動差異化獲利狀況並同時完成所有這些事情的能力感到非常興奮。

Sung Ji Nam, Scotiabank.

加拿大豐業銀行的 Sung Ji Nam。

Maybe on the UMBRELLA study with the 700 patients, is that enough for at least some of the indications that you mentioned for you to submit to Medicare for reimbursement? Or should we anticipate a few more studies of this size might be needed for you to do that?

也許在對 700 名患者進行的 UMBRELLA 研究中，這是否足以滿足您提到的至少部分適應症，以便您向 Medicare 提交報銷申請？或者我們應該預期您可能需要進行更多這種規模的研究才能做到這一點？

Well, first, let me answer by saying that you're probably always going to see more studies coming from us given our track record. The second is, yes, we do believe that the study is being appropriately designed in its prospective manner, and it will be sufficiently powered per indication to yield a positive coverage from Medicare.

嗯，首先，我想回答的是，鑑於我們以往的記錄，你可能會看到我們進行更多的研究。第二，是的，我們確實相信這項研究的前瞻性設計是適當的，並且每個適應症都有足夠的動力來獲得醫療保險的積極覆蓋。

Got it. And Rebecca, you mentioned your guidance raise for adjusted EBITDA margins for 2025. You attribute it to laboratory efficiency projects and timing of project spend. Kind of what -- could you elaborate a bit on the project spend, what that entailed?

知道了。麗貝卡，您提到了對 2025 年調整後 EBITDA 利潤率的預期上調。您將其歸因於實驗室效率專案和專案支出的時間。有點像——您能詳細說明一下項目支出嗎？它包含哪些內容？

Yes. Actually -- so one is a good guy, one is a bad guy, right? So Q1, we outperformed by, call it, around 150 basis points. We raised the guide by around 100 basis points. The delta between those two plus a little bit of the goodness from the gross margin projects is what we're relating to in project spend. Think of that, Sung Ji, as really R&D getting -- that we thought was going to be spent in Q1 getting pushed throughout the rest of the year, just timing.

是的。實際上──一個是好人，一個是壞人，對嗎？因此，第一季我們的表現超出預期，大約高出 150 個基點。我們將指導利率提高了約 100 個基點。這兩者之間的差額加上毛利率項目的一點點好處就是我們在專案支出中所考慮的。想想看，Sung Ji，這真的是研發——我們原以為會在第一季投入的資金，卻被推遲到了今年剩餘時間，只是時間問題。

Matt Sykes, Goldman Sachs.

高盛的馬特·賽克斯 (Matt Sykes)。

[Will] on for Matt. Can you talk about the initial response to the early launch of Decipher in the metastatic population and remind us of the potential contribution in the back half of the year following the broader launch?

[威爾] 替補馬特。您能否談談 Decipher 在轉移性患者群體中早期推出的初步反應，並提醒我們更廣泛推出後下半年的潛在貢獻？

Yes. The initial launch, as you can imagine, and the reason we did an initial launch is because we had physicians jumping up a bit to start to use this in patients. And I cited an example in the prepared remarks of an existing case, and that particular physician is very excited to be able to have that information. And so the -- it's early days. We just launched this at the end of April. But so far, we're quite excited about the reaction.

是的。正如您所想像的，首次發布以及我們進行首次發布的原因是因為我們的醫生們迫切希望開始在患者身上使用它。我在準備好的發言中引用了一個現有案例的例子，那位醫生對於能夠獲得這些資訊感到非常興奮。所以——現在還為時過早。我們剛剛在四月底推出了這個產品。但到目前為止，我們對大家的反應感到非常興奮。

Yes. We just came back from the AUA and there already the conversation was very strong around metastatic disease, and we expect the trend to continue at ASCO, where we will be in full launch mode, but I appreciate the question.

是的。我們剛從 AUA 回來，那裡關於轉移性疾病的討論已經非常熱烈，我們預計這種趨勢將在 ASCO 上繼續下去，我們將在那裡全面啟動，但我很感謝你提出這個問題。

And the ramp in the second half?

下半場的斜坡呢？

It's implied in the guide effectively. We are expecting this to be not dissimilar post the biopsy launch when it received Medicare in 2019. Obviously, that -- it will change the trajectory when we have guidelines, but we're not expecting that in the guide this year. So I think it's a contributing factor, but the vast majority of the growth this year will come from penetrating and share gains in the biopsy portion of the market.

指南中有效地暗示了這一點。我們預計，2019 年活檢技術納入醫療保險後，情況將不會有什麼不同。顯然，當我們有指導方針時，它就會改變軌跡，但我們並不期望今年的指南中會出現這一點。所以我認為這是一個促成因素，但今年的絕大部分成長將來自於市場活檢部分的滲透和份額的成長。

Understood. That's helpful. And then switching over to Afirma. How should we think about the components of growth for the rest of the year, I guess, excluding prior period collection impacts, including any potential benefits from the updated GRID offering?

明白了。這很有幫助。然後切換到 Afirma。我想，我們應該如何看待今年剩餘時間的成長要素，排除前期收集的影響，包括更新後的 GRID 產品可能帶來的好處？

Yes. Again, I take the updated GRID offering as kind of being table stakes for us at this point in time. I wouldn't -- it's needed to demonstrate the growth that we've talked about more so than driving a specific component of growth. It's just part of our overall strategy. We can't -- it's really challenging to parse out things like that.

是的。再次，我認為更新的 GRID 產品對我們來說就像是目前的賭注。我不會——它需要展示我們所談論的成長，而不是推動特定的成長要素。這只是我們整體策略的一部分。我們不能——分析出這樣的事情真的很有挑戰性。

But in general, we saw great volume growth in the first quarter. We would expect that volume -- pretty strong volume growth. Prior period collections for Afirma may end up to be a headwind for the rest of the year. We'll have to wait and see. And so between those two things, we're expecting high single-digit revenue growth.

但總體而言，第一季的銷售成長非常顯著。我們預計銷量會成長相當強勁。Afirma 前期的收款可能會成為今年剩餘時間的阻力。我們只能拭目以待。因此，在這兩件事之間，我們預計收入將實現高個位數成長。

How one nets out versus the other in any given quarter, I would love to be able to tell you. But that's not perfect. My crystal ball is not that clean.

我很想告訴你，在任何一個季度中，一個公司的淨利潤與另一個公司的淨利潤相比如何。但這並不完美。我的水晶球比較不乾淨。

Mason Carrico, Stephens Inc.

梅森·卡里科（Mason Carrico），史蒂芬斯公司

This is Ben on for Mason here. I'll just keep it to one here. Could you talk about the training that you've done with your sales force for the metastatic indication for Decipher? What are your thoughts on when these reps are going to be fully productive for that indication? And then, talking about the synergistic call point here, when you think about MRD coming online next year, how do you see reps prioritizing their time between MRD, Decipher and localized and then the Decipher metastatic?

這是本，代替梅森。我在這裡只保留一個。您能談談您對銷售人員進行的 Decipher 轉移性適應症的培訓嗎？您認為這些代表何時才能充分發揮這項作用？然後，談論這裡的協同呼叫點，當您想到 MRD 明年上線時，您如何看待銷售代表在 MRD、Decipher 和本地化以及 Decipher 轉移之間安排時間？

Yes. Excellent question, Ben. So on part one, we've started the training and those discussions at our national sales meeting in January. We just held an advanced training here in the last couple of weeks. That was full day of both content and tactical training.

是的。非常好的問題，本。因此，在第一部分中，我們已經在一月份的全國銷售會議上開始了培訓和討論。我們剛剛在過去幾週在這裡舉辦了一次高級培訓。那是一整天的內容和戰術訓練。

These are, in general, the call points that they are already calling on. So these are -- for the most part are large urology group practices. They routinely handle and manage patients with metastatic disease. So this is a natural extension of the discussions that they're having with those physicians in those group practices. For part two of your question and how we're managing and balancing our time, it is -- again, it is an extension of the call point.

一般來說，這些都是他們已經呼叫的呼叫點。所以這些 — — 大部分都是大型泌尿科團體診所。他們經常處理和管理患有轉移性疾病的患者。這是他們與這些團體診所的醫生進行的討論的自然延伸。對於你的問題的第二部分以及我們如何管理和平衡我們的時間，它是 - 再次，它是呼叫點的延伸。

We pride ourselves in training our sales reps to have meaningful and educational discussions in those practices. This would be a topic that they would rotate in as part of one of their visits into those practices.

我們很自豪能夠培訓我們的銷售代表在這些實踐中進行有意義且有教育意義的討論。這將是他們在訪問這些實踐時輪流討論的主題。

This concludes the question-and-answer session. I'd like to thank you for your participation in today's conference. This does conclude the program and you may now disconnect.

問答環節到此結束。感謝大家參加今天的會議。這確實結束了程序並且您現在可以斷開連接。