Veracyte Inc (VCYT) 2025 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the Veracyte third-quarter 2025 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

    您好,感謝您的耐心等待。歡迎參加 Veracyte 2025 年第三季財務業績電話會議。(操作人員指示)請注意,今天的會議正在錄音。

  • I would now like to hand the conference over to your first speaker today, Shayla Gorman.

    現在我謹將會議交給今天的第一位發言人,Shayla Gorman。

  • Shayla Gorman - Senior Director - Investor Relations

    Shayla Gorman - Senior Director - Investor Relations

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

    各位下午好,感謝各位今天參加我們關於2025年第三季財務業績的討論。今天陪我出席的有 Veracyte 的執行長 Marc Stapley 和財務長 Rebecca Chambers。我們的首席商務官約翰·萊特博士和首席醫療和科學官菲爾·費博博士將參加問答環節。

  • Veracyte issued a press release earlier this afternoon detailing our third 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.

    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年第三季的財務業績。本新聞稿以及我們將在今天電話會議上討論的簡報副本可在我們網站 veracyte.com 的投資者關係部分取得。

  • 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. 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.

    在開始之前,我想提醒各位,我們在本次電話會議中發表的聲明將包括適用證券法所定義的前瞻性聲明。前瞻性陳述存在風險和不確定性,公司無法保證其正確性。此外,我們沒有義務提供有關我們業務趨勢或本季業績的進一步更新資訊。

  • 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.

    為了更了解可能導致實際結果出現差異的風險和不確定性,我們建議您參閱 Veracyte 向美國證券交易委員會提交的文件,包括最新的 10-Q 表格和 10-K 表格。

  • 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,本次電話會議也將涉及一些非GAAP財務指標。這些指標與最直接可比較的 GAAP 財務指標的核對情況已包含在今天的收益報告中,該報告可從 Veracyte 網站的投資者關係部分取得。

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

    現在我將把電話交給 Veracyte 的執行長 Marc Stapley。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Thank you, Shayla, and thank you to everyone for joining us today. I'm pleased to share details of our third quarter performance as well as provide updates on our key growth drivers.

    謝謝Shayla,也謝謝今天到場的各位。我很高興與大家分享我們第三季的業績詳情,並提供我們關鍵成長驅動因素的最新資訊。

  • We delivered another outstanding quarter. Our core testing business achieved 18% revenue growth year over year after adjusting for Envisia, driven by volume growth of 26% in Decipher and 13% in Afirma. This strong performance resulted in total revenue growing 14% year over year to approximately $132 million, even after the expected dilutive impact of removing the biopharma and other revenue tied to SAS.

    我們又完成了一個出色的季度。在扣除 Envisia 的影響後,我們的核心檢測業務實現了 18% 的同比增長,這主要得益於 Decipher 銷量增長 26% 和 Afirma 銷量增長 13%。即使在扣除與 SAS 相關的生物製藥和其他收入的預期稀釋影響後,這一強勁的業績仍使總收入年增 14%,達到約 1.32 億美元。

  • In addition to our robust revenue performance, our adjusted EBITDA margin reached a record 30%, representing a 650 basis points improvement from the prior year and far exceeding our expectations. As you know, we had set a goal of consistently achieving a 25% adjusted EBITDA margin on an annual basis, and it now appears that we will reach that milestone this year, more than a year ahead of our internal plans.

    除了強勁的營收表現外,我們的調整後 EBITDA 利潤率也達到了創紀錄的 30%,比前一年提高了 650 個基點,遠遠超出了我們的預期。如您所知,我們設定了每年持續實現 25% 調整後 EBITDA 利潤率的目標,現在看來,我們將在今年實現這一里程碑,比我們內部計劃提前一年多。

  • This best-in-class profitability profile is a significant accomplishment, which we attribute to our disciplined portfolio focus. It enables us to continue to invest in our robust pipeline to serve as many patients as possible.

    這項一流的獲利能力是一項重大成就,我們將其歸功於我們嚴謹的投資組合策略。這使我們能夠繼續投資於我們強大的研發管線,從而服務盡可能多的患者。

  • The foundation we have built at Veracyte will enable sustained near- and long-term growth through a focused set of strategic drivers. I'm excited to share progress across several of these initiatives today.

    我們在 Veracyte 建立的基礎,將透過一系列重點策略驅動因素,實現持續的近期和長期成長。今天我很高興與大家分享其中幾項措施的進展。

  • Starting with Decipher. We delivered approximately 26,700 tests in Q3, marking the 14th consecutive quarter of over 25% year-over-year volume growth. With the highest number of quarterly ordering providers and the highest number of orders per physician, Decipher's clinical utility is increasingly recognized by physicians for patients across all risk categories.

    從 Decipher 開始。第三季我們交付了約 26,700 次檢測,這是連續第 14 季年增超過 25%。Decipher 擁有最多的季度訂購提供者和最多的每位醫生訂購數量,其臨床實用性正日益受到醫生的認可,適用於所有風險類別的患者。

  • This year, we have especially highlighted the clinical evidence for advanced disease, including high-risk localized and metastatic patients, where Decipher's predictive power has been shown to improve outcomes. With Decipher now available for metastatic patients, physicians can better assess the benefit of intensifying treatment with androgen receptor pathway inhibitors or chemotherapy.

    今年,我們特別強調了晚期疾病的臨床證據,包括高風險局部和轉移性患者,Decipher 的預測能力已被證明可以改善治療效果。現在,Decipher 可用於轉移性患者,醫生可以更好地評估使用雄激素受體路徑抑制劑或化療加強治療的益處。

  • For example, recent analysis from the STAMPEDE trial published in Cell showed a high Decipher score predicts docetaxel benefit in metastatic patients and abiraterone efficacy for those with metastatic and high-risk localized disease. During the quarter, our volume of tests in this high-risk localized group grew more than 30%, demonstrating new traction in this category. We believe there remains significant opportunity to expand Decipher's use in this segment.

    例如,發表在《細胞》雜誌上的 STAMPEDE 試驗的最新分析表明,較高的 Decipher 評分可以預測轉移性患者對多西他賽的療​​效,以及轉移性和高危險局部性疾病患者對阿比特龍的療效。本季度,我們在這一高風險局部群體中的檢測量增長了 30% 以上,表明該類別取得了新的進展。我們認為,Decipher 在該領域的應用仍有很大的拓展空間。

  • Consistent with our established formula for evidence generation as the key to broad adoption, we continue to support extensive research in prostate cancer. For example, at ASTRO in September, research collaborators presented the first validation data from the BALANCE trial, demonstrating the PAM50 molecular signature predicts hormone therapy benefit in men with recurrent prostate cancer using data from our research use only Decipher GRID.

    秉持著我們以證據生成為廣泛應用的關鍵的既定原則,我們將繼續支持對前列腺癌的廣泛研究。例如,在 9 月的 ASTRO 會議上,研究合作者展示了 BALANCE 試驗的首個驗證數據,證明 PAM50 分子特徵能夠預測復發性前列腺癌男性接受荷爾蒙治療的獲益,而這些數據僅來自我們用於研究的 Decipher GRID。

  • This signature, well known in the breast cancer oncologist community and the backbone of our Prosigna test has now been shown to be able to stratify prostate cancer patients based on subtype, providing confidence in hormone therapy benefit for those with the Luminal B subtype.

    這項特徵在乳癌腫瘤學家群體中廣為人知,也是我們 Prosigna 測試的基礎,現在已被證明能夠根據亞型對前列腺癌患者進行分層,從而為 Luminal B 亞型患者提供激素治療獲益的信心。

  • In addition to demonstrating the power of GRID and driving new important research in prostate cancer, this trial also builds on research presented earlier this year from the SSPORT trial, which showed the biochemical recurrence or BCR post-surgery patients with a high Decipher score received greater benefit from the addition of pelvic node radiotherapy and short-term ADT.

    除了展示 GRID 的強大功能並推動前列腺癌領域的重要新研究外,該試驗還建立在今年早些時候公佈的 SSPORT 試驗的研究基礎上,該試驗表明,Decipher 評分高的術後生化復發 (BCR) 患者從骨盆淋巴結放射治療和短期 ADT 中獲益更多。

  • These BCR patients represent a potential incremental opportunity for Decipher as we believe the majority never received a Decipher test when they were initially diagnosed with prostate cancer and would now be appropriate candidates for testing post-surgery.

    這些 BCR 患者代表了 Decipher 的一個潛在成長機會,因為我們相信大多數患者在最初被診斷出患有前列腺癌時從未接受過 Decipher 檢測,現在他們將成為術後檢測的合適人選。

  • The complex treatment decisions faced by physicians and their patients dealing with advanced disease requires robust actionable information. As research empowered by GRID establishes clinical utility for new signatures, we are working to add such additional molecular features to the Decipher report to enhance clinical insights.

    醫生及其患者在面對晚期疾病時,需要做出複雜的治療決策,而這些決策需要可靠且可操作的資訊。隨著 GRID 推動的研究不斷確立新特徵的臨床應用價值,我們正在努力將這些額外的分子特徵添加到 Decipher 報告中,以增強臨床見解。

  • Signatures like PORTOS and PTEN will be available in the optional Molecular Features Report when it launches next year. PORTOS predicts which patients with prostate cancer are likely to benefit from differing dosages of salvage and definitive radiation therapy. PTEN used alongside the Decipher score showed promise in determining whether metastatic patients would benefit from chemotherapy in the STAMPEDE study.

    PORTOS 和 PTEN 等特徵譜將在明年推出的可選分子特徵報告中提供。PORTOS 預測哪些攝護腺癌患者可能從不同劑量的挽救性放射治療和根治性放射治療中獲益。在 STAMPEDE 研究中,PTEN 與 Decipher 評分結合使用,在確定轉移性患者是否能從化療中獲益方面顯示出了前景。

  • These additions will further extend Decipher's application across indications, treatment decisions and various health care specialists. These studies represent only a selection of the extensive ongoing research related to Decipher. This quarter, we saw 23 new abstracts and publications on Decipher Prostate and GRID, bringing the total to 240 publications.

    這些新增功能將進一步擴展 Decipher 的應用範圍,涵蓋更多適應症、治療決策以及各類醫療保健專家。這些研究僅代表與 Decipher 相關的眾多正在進行的研究中的一部分。本季度,我們看到了 23 篇關於 Decipher Prostate 和 GRID 的新摘要和出版物,使出版物總數達到 240 篇。

  • Notably, at ASTRO 2025, of the 9 Decipher-focused abstracts, 2 compared the results of the Decipher test to the on-market DPAI solution and found marginal correlation. Investigators concluded that the two tests are measuring different biological processes, something we have asserted for a while based on prior studies. Further, there was meaningful discordance between the two tests across risk categories with a bias to low and therefore, potential undertreatment from DPAI.

    值得注意的是,在 ASTRO 2025 上,9 篇以 Decipher 為重點的摘要中,有 2 篇將 Decipher 測試的結果與市場上的 DPAI 解決方案進行了比較,發現相關性很弱。調查人員得出結論,這兩個測試測量的是不同的生物過程,我們根據先前的研究已經斷言了這一點。此外,兩種測試在風險類別之間存在顯著差異,存在偏向低風險的偏差,因此 DPAI 可能導致治療不足。

  • These findings support our view that digital pathology may complement molecular analysis by providing additional data points based on a more comprehensive analysis of tumor histology, but further research is needed to determine optimal use and to protect patients.

    這些發現支持了我們的觀點,即數位病理學可以透過提供基於更全面的腫瘤組織學分析的額外數據點來補充分子分析,但還需要進一步的研究來確定最佳用途並保護患者。

  • To support this, we made our digital pathology services and associated AI models available to research collaborators earlier this year and have now implemented slide scanning as a standard production workflow. We've made tremendous progress in the third quarter and have now scanned over 115,000 slides from over 80,000 de-identified patients with outcomes data and expect this database to grow meaningfully as we continue building our digital image repository.

    為了支持這一目標,我們在今年稍早向研究合作者提供了數位病理學服務和相關的 AI 模型,現在已將玻片掃描作為標準生產工作流程實施。我們在第三季度取得了巨大的進展,目前已掃描了來自 80,000 多名匿名患者的 115,000 多張幻燈片,並收集了結果數據。隨著我們繼續建立數位影像庫,預計該資料庫將顯著成長。

  • Looking forward, the expanding clinical evidence supporting Decipher gives us confidence in its long-term growth prospects. With data consistently demonstrating its clinical utility and impact on patient management, Decipher is increasingly becoming the standard of care in prostate cancer. We see a long runway ahead, further bolstered by ongoing prospective studies to drive broader physician adoption, resulting in durable double-digit growth for years to come.

    展望未來,不斷增加的臨床證據支持 Decipher,這讓我們對其長期成長前景充滿信心。Decipher 的數據不斷證明其臨床實用性和對患者管理的影響,它正日益成為前列腺癌的標準治療方法。我們看到未來還有很長的發展道路,正在進行的前瞻性研究將進一步推動醫生更廣泛地採用該技術,從而在未來幾年內實現兩位數的持續增長。

  • Turning to Afirma. We were incredibly pleased with the 13% volume growth in Q3. This outstanding performance was driven by a steady pipeline of new account wins and yet another quarter of increased utilization per account. We also had a strong showing at the 2025 American Thyroid Association meeting, where we supported the presentation of 12 Afirma-related abstracts, including four independent studies utilizing data from Afirma GRID.

    轉向 Afirma。我們對第三季13%的銷售成長感到非常滿意。這項卓越業績得益於持續不斷的新客戶拓展以及每個客戶使用率連續第二季的提升。我們在 2025 年美國甲狀腺協會會議上也取得了不錯的成績,我們支持發表了 12 篇與 Afirma 相關的摘要,其中包括四項利用 Afirma GRID 數據的獨立研究。

  • Our operational efficiency program for Afirma is progressing nicely as we have transitioned over 1/3 of samples onto our new v2 transcriptome in the lab and having received New York State approval are on track to complete the transition of all incoming Afirma samples to the new workflow by year-end. While the data is early, we are pleased to see a side benefit in that the lower RNA input required by the new workflow has enabled even more patients to get a test result.

    我們針對 Afirma 的營運效率提升計畫進展順利,目前已將超過 1/3 的樣本轉移到實驗室新的 v2 轉錄組,並且已獲得紐約州的批准,預計在年底前完成所有傳入的 Afirma 樣本向新工作流程的過渡。雖然數據尚處於早期階段,但我們很高興地看到,新工作流程所需的 RNA 輸入量減少,使得更多患者能夠獲得檢測結果,這是一個意想不到的好處。

  • Moving to our commitment to serve more of the patient journey through MRD and recurrence testing, we are excited about the opportunity for our whole genome-based MRD platform. Multiple studies are already completed in muscle invasive bladder cancer or MIBC, colorectal cancer or CRC, lung and other cancers with a robust pipeline, including 10 studies in testing and/or analysis, 13 in contracting and 10 in the active planning stage.

    為了更好地服務患者的整個治療過程,我們致力於透過 MRD 和復發檢測,為患者提供更全面的服務。我們對基於全基因組的 MRD 平台所帶來的機會感到興奮。目前,針對肌肉層浸潤性膀胱癌(MIBC)、結直腸癌(CRC)、肺癌和其他癌症的多項研究已經完成,並擁有強大的研發管線,其中包括 10 項處於測試和/或分析階段的研究、13 項處於合約簽訂階段的研究和 10 項處於積極規劃階段的研究。

  • This includes additional studies in MIBC as well as in breast, lung, CRC, kidney, immune therapy treatment response and others. The enthusiastic engagement by collaborators at leading institutions, along with the early results we are seeing reinforce our bullish expectations of our ability to capture a meaningful share of the pan-cancer market with our differentiated approach, which we have branded as TrueMRD.

    這包括在肌肉層浸潤性膀胱癌 (MIBC) 以及乳癌、肺癌、大腸直腸癌 (CRC)、腎癌、免疫療法治療反應等方面的額外研究。領先機構的合作者的熱情參與,以及我們看到的早期成果,都增強了我們對憑藉我們獨特的方法(我們稱之為 TrueMRD)在泛癌市場中佔據重要份額的樂觀預期。

  • We are now receiving samples for the first phase of the NEO-BLAST trial. With growing enthusiasm over the efficacy of combination therapies like enfortumab vedotin and pembrolizumab or EV Pembro, there is keen interest in moving towards therapy de-intensification. The NEO-BLAST trial has the potential to help inform which patients can be de-intensified following standard of care neoadjuvant therapy.

    我們現在正在接收 NEO-BLAST 試驗第一階段的樣本。隨著人們對恩福妥單抗和帕博利珠單抗(或 EV Pembro)等聯合療法的療效越來越感興趣,人們對降低治療強度產生了濃厚的興趣。NEO-BLAST 試驗有可能幫助確定哪些患者在接受標準新輔助治療後可以降低治療強度。

  • MIBC patients are being tested with standard staging MRI and TrueMRD. If they achieve a complete clinical response and are undetectable by MRD, they will be randomized to definitive local therapy or bladder-sparing active surveillance. We are excited to advance this trial and further the understanding of when a physician can safely de-intensify treatment for these patients.

    MIBC 患者正在接受標準分期 MRI 和 TrueMRD 檢測。如果患者達到完全臨床緩解且 MRD 檢測不到病灶,則隨機分配至根治性局部治療組或保留膀胱的主動監測組。我們很高興能夠推進這項試驗,並進一步了解醫生何時可以安全地降低這些患者的治療強度。

  • Our commercial success in MRD will begin with our proof of concept in MIBC in the first half of 2026, which we plan to launch with reimbursement. We expect to leverage our Decipher channel, which we believe reaches approximately 70% of MIBC patients who are seen in the urology and radiation oncology setting. Beyond MIBC, we plan to deliver indication expansion annually in order to serve more patients across more indications.

    我們在 MRD 領域的商業成功將始於我們在 2026 年上半年對 MIBC 的概念驗證,我們計劃在獲得報銷後推出該產品。我們期望利用我們的 Decipher 管道,我們相信該渠道可以覆蓋在泌尿科和放射腫瘤科就診的約 70% 的 MIBC 患者。除了 MIBC 之外,我們計劃每年擴大適應症範圍,以便為更多患者提供更多適應症的服務。

  • Moving now to Prosigna. We are on track to launch Prosigna as an LDT for the US breast cancer market in the middle of 2026, given the tremendous opportunity we see ahead. The clinical outcomes data from the 10-year OPTIMA PRELIM study presented in May suggested Prosigna had higher prognostic accuracy in high-risk patients compared to the test initially used to assign patients to treatment groups.

    現在轉到Prosigna。鑑於我們看到的巨大機遇,我們正按計劃於 2026 年年中在美國乳癌市場推出 Prosigna 作為實驗室自建檢測 (LDT)。5 月公佈的為期 10 年的 OPTIMA PRELIM 研究的臨床結果數據顯示,與最初用於將患者分配到治療組的測試相比,Prosigna 在高風險患者中具有更高的預後準確性。

  • We're excited to see the readout of the full OPTIMA trial, which is the first prospective study to specifically address Prosigna's ability to identify clinically high-risk patients who do not benefit from chemotherapy and can safely avoid the toxicities associated with treatment.

    我們非常期待看到完整的 OPTIMA 試驗結果,這是首個前瞻性研究,專門探討 Prosigna 能否識別臨床高風險患者,這些患者無法從化療中獲益,並且可以安全地避免與治療相關的毒性。

  • New studies also continue to highlight the use of Prosigna for guiding preoperative therapy. An IMPACT study led by Dana-Farber Cancer Institute investigators and recently published in ESMO Open demonstrated a change in therapy in 35% of patients based on Prosigna results.

    新的研究也持續強調了Prosigna在指導術前治療的應用。由 Dana-Farber 癌症研究所的研究人員領導的 IMPACT 研究最近發表在 ESMO Open 上,該研究表明,根據 Prosigna 的結果,35% 的患者的治療方案發生了改變。

  • At ESMO last month, investigators reported preliminary results of the RIBOLARIS study in which patients with clinically high-risk ER-positive breast cancer were treated with preoperative endocrine therapy plus Ribociclib, a CDK4/6 inhibitor. Prosigna was used to identify patients who achieved a low-risk molecular profile post therapy, allowing a mission of adjuvant chemotherapy. Additional follow-up is required for definitive results, but this study and other preoperative studies underway demonstrate how Prosigna enables precision medicine.

    上個月在 ESMO 會議上,研究人員報告了 RIBOLARIS 研究的初步結果,該研究對臨床高風險 ER 陽性乳癌患者進行了術前內分泌治療,並加用 CDK4/6 抑制劑 Ribociclib 進行治療。Prosigna 用於識別治療後達到低風險分子特徵的患者,從而可以進行輔助化療。還需要進一步的後續研究才能得出最終結果,但這項研究和其他正在進行的術前研究表明,Prosigna 如何實現精準醫療。

  • As you can see, we have continued to advance our robust pipeline, having launched Decipher Metastatic in June, completed our NIGHTINGALE lung cancer trial enrollment of 2,400 patients in August and deployed our v2 transcriptome assay. We are making good progress on our MRD, Prosigna and IVD products. With so many new products and capabilities in these two years alone, I couldn't be prouder of the Veracyte team who are working tirelessly on behalf of our patients.

    如您所見,我們一直在推進我們強大的研發管線,我們在 6 月推出了 Decipher Metastatic,在 8 月完成了 NIGHTINGALE 肺癌試驗的 2400 名患者招募,並部署了我們的 v2 轉錄組檢測。我們的 MRD、Prosigna 和 IVD 產品都取得了良好進展。僅僅這兩年,Veracyte 就推出了這麼多新產品和新功能,我為 Veracyte 團隊感到無比自豪,他們為了我們的患者不懈地努力。

  • Looking ahead, we will be accelerating our investments into our critical projects while maintaining the best-in-class financial profile we've consistently achieved. The strong momentum we have seen this year, together with the impact we expect to make with our upcoming product launches gives us confidence that we will continue to deliver comfortably durable long-term double-digit growth as we relentlessly pursue our mission of improving cancer care for patients all over the world.

    展望未來,我們將加快關鍵項目的投資,同時保持我們一直以來所取得的一流財務狀況。今年我們所看到的強勁勢頭,以及我們預期即將推出的產品所帶來的影響,使我們有信心繼續實現長期穩定的兩位數增長,同時我們將繼續不懈地追求改善全球癌症患者護理的使命。

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

    接下來,我將請 Rebecca 為我們回顧第三季的財務表現以及我們更新的 2025 年展望。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Thanks, Marc. Q3 was another exceptional quarter with $131.9 million in revenue, an increase of 14% over the prior year period. We grew total volume to approximately 45,900 tests, an 18% increase over the same period in 2024.

    謝謝你,馬克。第三季又是業績優異的季度,營收達 1.319 億美元,比上年同期成長 14%。我們的總檢測量成長至約 45,900 次,比 2024 年同期成長 18%。

  • Testing revenue during the quarter was $127.8 million, an increase of 17% year over year, driven by Decipher and Afirma revenue growth of 26% and 7%, respectively. Total testing volume was approximately 43,700 tests, an increase of 19% over the prior year period and included 17,000 Afirma tests.

    本季測試營收為 1.278 億美元,年增 17%,主要得益於 Decipher 和 Afirma 的營收分別成長了 26% 和 7%。總檢測量約為 43,700 次,比去年同期增加 19%,其中包括 17,000 次 Afirma 檢測。

  • Testing ASP was $2,925, a decrease of 2% compared to the prior year, primarily driven by the impact of higher prior period collections in Q3 2024 as well as the Afirma Laboratory Benefit Manager impact previously discussed. Adjusting for the impact of approximately $2.5 million of prior period collections in the quarter, testing ASP would have been approximately $2,875, flat to the prior year period.

    測試 ASP 為 2,925 美元,比上年下降 2%,主要原因是 2024 年第三季前期收款額較高,以及先前討論過的 Afirma Laboratory Benefit Manager 的影響。考慮到本季前期約 250 萬美元的收款影響,測試平均售價約為 2,875 美元,與去年同期持平。

  • Third quarter product volume was approximately 2,200 tests and product revenue was $3.3 million, up 4% year over year. Biopharmaceutical and other revenue was $800,000, a decrease compared to the $3.1 million in the third quarter of 2024, given the Veracyte SAS restructuring and liquidation proceedings.

    第三季產品銷售約 2,200 次測試,產品收入為 330 萬美元,較去年同期成長 4%。生物製藥和其他收入為 80 萬美元,與 2024 年第三季的 310 萬美元相比有所下降,這是由於 Veracyte SAS 的重組和清算程序所致。

  • Moving to gross margin and operating expenses, I will discuss our non-GAAP results. Non-GAAP gross margin was 73%, up approximately 150 basis points compared to the prior year period. Testing gross margin of 74% exceeded our expectations, driven by improved lab efficiencies and was roughly flat to the prior year.

    接下來,我將討論毛利率和營運費用,以及我們的非GAAP績效。非GAAP毛利率為73%,較上年同期成長約150個基點。測試毛利率達到 74%,超出預期,這主要得益於實驗室效率的提高,與前一年基本持平。

  • Product margin was approximately 800 basis points higher than the prior year at 52%. We still expect product gross margin to decline in Q4 with our transition to a contract manufacturing model. Biopharmaceutical and other gross margin of negative 36% was down year over year due to the restructuring proceedings of Veracyte SAS.

    產品利潤率比上年同期高出約 800 個基點,達到 52%。由於我們向代工生產模式轉型,我們預計第四季度產品毛利率仍將下降。由於 Veracyte SAS 的重組程序,生物製藥和其他業務的毛利率比去年同期下降了 36%。

  • Non-GAAP operating expenses were up 2% year over year to $58.6 million. Compared to the prior year, research and development expenses decreased by $2 million to $14 million, driven primarily by the deconsolidation of Veracyte SAS. Sales and marketing expenses increased by $1.5 million to $22.4 million, given higher personnel costs supporting Decipher and Afirma. G&A expenses were up $1.5 million to $22.3 million, primarily due to project-related expenses within our support functions.

    非GAAP營運費用年增2%至5,860萬美元。與前一年相比,研發費用減少了 200 萬美元,降至 1,400 萬美元,主要是由於 Veracyte SAS 的剝離所致。由於支持 Decipher 和 Afirma 的人員成本增加,銷售和行銷費用增加了 150 萬美元,達到 2,240 萬美元。一般及行政費用增加 150 萬美元,達到 2,230 萬美元,主要是因為支援職能部門的專案相關費用增加。

  • Moving to profitability and cash metrics. We recorded GAAP net income of $19.1 million, including a $6.7 million loss upon deconsolidation of Veracyte SAS. This is onetime in nature and puts the France accounting impact behind us.

    接下來討論獲利能力和現金流指標。我們錄得 GAAP 淨收入 1,910 萬美元,其中包括因 Veracyte SAS 停止合併而產生的 670 萬美元損失。這是一次性事件,法國會計方面的影響已經過去。

  • Adjusted EBITDA was $39.7 million or 30.1% of revenue, well above our expectations given the benefit of prior period collections, lab efficiencies and the timing of some project investments, which are now forecasted to occur in the fourth quarter and into 2026. We generated $44.8 million of cash from operations and ended the quarter with $366 million of cash and cash equivalents.

    經調整後的 EBITDA 為 3,970 萬美元,佔收入的 30.1%,遠超我們的預期,這得益於前期收款、實驗室效率的提高以及一些專案投資的時間安排,這些投資預計將在第四季度及 2026 年完成。我們從經營活動中產生了 4,480 萬美元的現金,季末現金及現金等價物總額為 3.66 億美元。

  • Turning now to our 2025 outlook. We are raising our 2025 total revenue guidance to $506 million to $510 million from our prior guidance of $496 million to $504 million. Due to our strong year-to-date performance, we are raising testing revenue guidance to $484 million to $487 million from our prior guidance of $477 million to $483 million. This reflects a raised Decipher outlook and continued Afirma volume strength.

    現在讓我們展望一下2025年。我們將 2025 年總營收預期從先前的 4.96 億美元至 5.04 億美元上調至 5.06 億美元至 5.1 億美元。由於我們今年迄今的強勁業績,我們將測試收入預期從先前的 4.77 億美元至 4.83 億美元上調至 4.84 億美元至 4.87 億美元。這反映了Decipher前景的提升和Afirma成交量的持續強勁。

  • As a result, testing revenue growth is now estimated to be 16% as compared to the prior guidance of 14% to 15%. We are also raising adjusted EBITDA margin guidance for the year to exceed 25% from our previous guidance of 23.5%, which was already meaningfully higher than our original 21.6% 2025 guide. This reflects our year-to-date profitability outperformance and expectations for accelerated investment in the fourth quarter in support of our strategic growth drivers.

    因此,測試收入成長預計為 16%,而先前的預期為 14% 至 15%。我們同時將本年度調整後 EBITDA 利潤率預期從先前的 23.5% 上調至超過 25%,而先前的預期已顯著高於我們最初設定的 2025 年 21.6% 的預期。這反映了我們今年迄今的獲利能力超預期,以及為支持我們的策略成長動力,我們將在第四季度加快投資的預期。

  • We expect adjusted EBITDA margin to be approximately 25% in the fourth quarter and in future years, barring any specific incremental investments we decide to make, which we would, of course, communicate as appropriate.

    我們預計第四季度及未來幾年的調整後 EBITDA 利潤率約為 25%,除非我們決定進行任何特定的額外投資,當然,我們會在適當的時候進行溝通。

  • In closing, I am thrilled with our progress over the course of 2025. As Marc shared, we delivered on our product goals this year, including the launch of Decipher for metastatic patients and the transition of Afirma to the v2 transcriptome. With strong momentum heading into year-end, I'm excited to close out a successful 2025 and have confidence in our trajectory for '26 and beyond.

    最後,我對我們在 2025 年的進展感到非常興奮。正如 Marc 所說,我們今年實現了產品目標,包括推出用於轉移性患者的 Decipher 以及將 Afirma 過渡到 v2 轉錄組。憑藉著強勁的勢頭進入年底,我對2025年的成功充滿信心,並對2026年及以後的發展軌跡充滿信心。

  • We'll now go into the Q&A portion of the call. Operator, please open the line.

    接下來我們將進入問答環節。接線員,請接通線路。

  • Operator

    Operator

  • (Operator Instructions) Doug Schenkel, Wolfe Research.

    (操作員說明)Doug Schenkel,Wolfe Research。

  • Doug Schenkel - Equity Analyst

    Doug Schenkel - Equity Analyst

  • So I want to ask, I think -- I guess, two for Marc, and then I guess if I can take the liberty to ask a financial question of Rebecca. So on Marc, digital pathology, there were several presentations as you talked about in your prepared remarks at the ASTRO Annual Meeting showing weak correlation between multimodal AI scores and Decipher. As you talked about, it suggests these assays are complementary.

    所以我想問——我想問馬克兩個問題,然後我想我可以冒昧地問麗貝卡一個關於財務的問題嗎?所以,關於 Marc 的數位病理學,正如您在 ASTRO 年會上準備好的發言稿中所提到的,有好幾份報告都顯示多模態 AI 分數與 Decipher 之間的相關性很弱。正如你所說,這表明這些檢測方法是互補的。

  • Just on that topic, I'm curious, how do clinicians manage discordant results? Do you see this as being a concern for Decipher? Or is this something that you think actually leads folks to maybe kind of prioritize Decipher over some of the emerging competitors? And then maybe while we're on the topic, could you just talk a little bit about your own internal digital pathology efforts and kind of what the time lines are there?

    關於這一點,我很好奇,臨床醫生是如何處理不一致的結果的?你認為這對 Decipher 來說是個問題嗎?或者,你認為這實際上會導致人們優先考慮 Decipher 而不是一些新興的競爭對手嗎?那麼,既然我們談到了這個話題,您能否談談貴公司內部的數位病理學工作以及相關的進度安排?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. Happy to, Doug, and then we can get to your financial questions. And actually, I'll answer these questions, and then I'll turn a little bit to John on the commercial aspects and Phil on the DPAI internal digital program.

    是的。樂意之至,道格,然後我們就可以解答你的財務問題了。實際上,我會回答這些問題,然後我會稍微請約翰談談商業方面的問題,再請菲爾談談DPAI內部的數位專案。

  • But I think the way to think about this is if you think about new technologies, including genomics of 10 or a dozen years ago, there's a lot of excitement and new tests come out. And I think what's really important is to go at an appropriate pace, develop the clinical evidence and make sure that evidence supports the utility and most importantly, the patients aren't getting harmed by the wrong decisions and the physicians aren't getting confused.

    但我認為思考這個問題的方式是,想想十年前或十幾年前的新技術,包括基因組學,當時人們非常興奮,新的測試方法層出不窮。我認為真正重要的是要以適當的速度推進,累積臨床證據,並確保這些證據支持其效用,最重要的是,確保患者不會因錯誤的決定而受到傷害,醫生也不會感到困惑。

  • This is kind of the formula we took with Decipher and letting the research community help drive the research behind Decipher, which is what we believe has resulted in it being so popular. I think we're at that stage now with DPAI-based models, right? It's exciting technology. It's new, but enough evidence hasn't been generated yet. And then -- and so you do get discordant results.

    這與我們開發 Decipher 的想法類似,我們讓研究界幫助推動 Decipher 背後的研究,我們認為這正是它如此受歡迎的原因。我認為我們現在基於 DPAI 的模型就處於那個階段,對吧?這項技術令人興奮。雖然是新現象,但目前還沒有足夠的證據。然後——因此你會得到不一致的結果。

  • And there isn't anything to tell the physician what to do in that case. And so what they do is pretty logical.

    在這種情況下,沒有任何規定可以告訴醫生應該怎麼做。所以他們的做法其實很合乎邏輯。

  • They focus on the gold standard, which, frankly, is Decipher. So if you've got a Decipher high and you have a DPAI-based low result, you certainly wouldn't want to undertreat that patient. And so you would focus on the Decipher result, treat accordingly, but the DPAI, the new technology loses credibility. And I think that's a bad thing for the industry as a whole.

    他們專注於黃金標準,坦白說,那就是 Decipher。所以,如果 Decipher 評分很高,而 DPAI 評分很低,你肯定不想對該患者治療不足。因此,你會關注 Decipher 的結果,並據此進行處理,但 DPAI 這種新技術卻失去了可信度。我認為這對整個行業來說是一件壞事。

  • So our approach of making sure that we are really focused on developing the evidence and letting the research community do that is what we think will ultimately drive success for a technology that should have its place if done the right way.

    因此,我們採取的策略是確保我們真正專注於開發證據,並讓研究界來完成這項工作,我們認為這最終將推動這項技術取得成功,如果以正確的方式進行,這項技術理應佔有一席之地。

  • Let me turn over to John on the commercial side, what we're hearing from physicians.

    接下來,我請約翰從商業角度談談我們從醫生那裡聽到的情況。

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • Yes. Thanks, Marc, and thanks, Doug. It's a good question. It's difficult for us to firmly lean into this concept of complementarity while we are seeing significant rates of discordance. And while it leads to physicians ultimately then being confused as to how to interpret the results and how to proceed with the patient.

    是的。謝謝馬克,也謝謝道格。這是個好問題。當我們看到大量不一致的情況時,很難堅定地接受互補性這個概念。但這最終會導致醫生們對如何解讀結果以及如何對病人進行治療感到困惑。

  • And so on the commercial side, we're spending a lot of time or revisiting the wealth of evidence substantiating the clinical validation and utility of Decipher versus that of emerging technologies.

    因此,在商業方面,我們花了大量時間重新審視大量證據,以證實 Decipher 的臨床驗證和實用性,並將其與新興技術進行比較。

  • And ultimately, physicians and based on the results of a survey that we've run, they heavily lean on the evidence that's currently substantiating Decipher and they see it as the current standard of care. Moving forward, we would hope that complementarity becomes more defined around how are insights to be developed in the best platform that ultimately associates a result with a clinical outcome and that will inform the right patient management decision.

    最終,根據我們進行的一項調查結果,醫生們非常依賴目前支持 Decipher 的證據,並將其視為目前的護理標準。展望未來,我們希望圍繞如何在最佳平台上發展洞察力,從而將結果與臨床結果聯繫起來,並為正確的患者管理決策提供信息,從而更好地界定互補性。

  • To do that, as Marc mentioned, we're working very closely with our current network of collaborators, key opinion leaders. Ultimately, we will curate and develop new signatures that will land on GRID.

    正如馬克所提到的那樣,為了實現這一目標,我們正在與我們目前的合作者網絡和關鍵意見領袖密切合作。最終,我們將策劃並開發新的簽名,這些簽名將出現在 GRID 上。

  • Ultimately, those will make their way into an equivalent of Molecular Features Report, such as we're doing now with the current GRID. And that's what true complementary in my mind, looks like. It's the rounding of clinical decisions aggregated and curated by an actionable report.

    最終,這些結果將進入相當於分子特徵報告的程式中,就像我們現在對目前 GRID 所做的那樣。在我看來,這才是真正的互補。它是將臨床決策進行匯總和整理,並形成可操作報告的結果。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • And then maybe, Phil, anything to add standpoint of the internal development program?

    那麼,菲爾,從內部發展計畫的角度來看,你還有什麼要補充的嗎?

  • Phillip Febbo - Chief Scientific Officer, Chief Medical Officer

    Phillip Febbo - Chief Scientific Officer, Chief Medical Officer

  • Yes. Happy to, Doug, and thanks for the question. So being a custodian of over 200,000 transcriptomes and incorporating pathology scanning of whole slide images into our research program, we are in a very -- we have probably the best and most comprehensive data set where we can dig into that interface that John was talking about and figure out how to take the best of both the transcriptome, which is represented the Decipher commercially and the emerging excitement around DPAI.

    是的。樂意效勞,道格,謝謝你的提問。因此,作為擁有超過 20 萬個轉錄組的保管者,並將全切片圖像的病理掃描納入我們的研究計劃,我們擁有可能是最好、最全面的數據集,我們可以深入研究 John 所說的那個界面,並弄清楚如何充分利用轉錄組(Decipher 代表其商業價值)和圍繞 DPAI 的新興熱情。

  • That is in full steam. We're digging in with collaborators as we've done with transcriptomes through the GRID. We're working with external -- some of the top investigators to drive that research forward and as well as both developing a model under -- as a DPAI model as well as understanding the interface and the biology that's measured there.

    目前進展順利。我們正在與合作者一起深入研究,就像我們透過 GRID 研究轉錄組一樣。我們正在與外部一些頂尖的研究人員合作,以推進這項研究,並開發一個模型——作為 DPAI 模型,同時了解介面以及在那裡測量的生物學。

  • We also have looked at that and see that it can help some of the prognostic, but we're also really understanding that through the GRID work we've done, we see a lot of opportunity, as Marc mentioned, on the molecular features that are coming out of the GRID and the different signatures. And we're excited about the LumB, non-LumB distinction that we saw presented at ASTRO.

    我們也研究過這一點,發現它可以幫助進行一些預後判斷,但我們也真正理解到,透過我們所做的 GRID 工作,我們看到了很多機會,正如 Marc 所提到的,那就是 GRID 產生的分子特徵和不同的標誌。我們對在 ASTRO 上提出的 LumB 和非 LumB 的區別感到非常興奮。

  • We're excited about the P10 activity, that's STAMPEDE activities. And we're seeing a number of the signatures that are predictive for therapeutic benefit. And so we are in an excellent place to look at the interface between the two. Right now, we're driving forward with the molecular features because they're predictive, and we're in the best position of anybody to bring digital pathology into the clinic in a complementary and in a rigorous way.

    我們對 P10 的活動,也就是 STAMPEDE 活動感到非常興奮。我們看到了一些可以預測治療效果的特徵。因此,我們現在處於一個非常好的位置,可以研究這兩者之間的介面。目前,我們正在大力推進分子特徵的研究,因為它們具有預測性,而且我們比任何人都更有優勢,能夠以補充和嚴謹的方式將數位病理學引入臨床。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Thanks, Phil. Okay. And Doug, you had a -- sorry, hopefully, we answered that question and you had a question on financial.

    謝謝你,菲爾。好的。道格,你有一個——抱歉,希望我們已經回答了你的問題,你還有一個關於財務的問題。

  • Doug Schenkel - Equity Analyst

    Doug Schenkel - Equity Analyst

  • Yes. No, that was fantastic, and I appreciate all the detail. And in an effort to be respectful to my sell-side peers, I'm going to try to make the follow-up a much quicker one. I think for Rebecca, you're a year ahead of plan on margin targets, which is fantastic. There are areas you've talked about planning to invest in next year, like I think building up the breast channel is one example.

    是的。不,那太棒了,我很欣賞所有的細節。為了表示對賣方同業的尊重,我將盡量加快後續跟進的速度。我認為對於 Rebecca 來說,你的利潤率目標比計劃提前了一年,這太棒了。您曾談到計劃明年投資的領域,例如我認為發展母乳哺育管道就是一個例子。

  • How are you contemplating balancing the margin trajectory and the upside that you're generating with maybe the opportunity to opportunistically maybe pull forward some investment in a period of strength to drive future growth? Would be curious to just get your thinking and obviously, that helps us as we're contemplating the model updates.

    您是如何考慮在保證利潤率的同時,抓住機遇,在市場強勁時期提前進行一些投資以推動未來成長的呢?很想了解您的想法,這顯然對我們正在考慮車型更新時很有幫助。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Yes, absolutely. Thanks, Doug, for the question. And you're right, we're in a very privileged position that we've gotten to based on really solid portfolio management and planning and quite regimented project prioritization. And I don't expect that to change. We have also a number of different initiatives that we're undertaking.

    是的,絕對的。謝謝你的提問,道格。你說得對,我們目前所處的地位非常優越,這得益於我們非常穩健的投資組合管理和規劃,以及相當嚴格的專案優先排序。我不認為這種情況會改變。我們目前也正在進行一些不同的項目。

  • As we did our strategic plan this year, we actually thought that the number of opportunities we had to invest in was almost embarrassing. It was a wealth of riches. And we remain in an incredibly fortunate position in terms of being able to help patients across the cancer care continuum with those investments. And so we are accelerating them to your point.

    今年我們制定策略計畫時,發現可供投資的機會之多,簡直令人尷尬。那簡直是一筆巨大的財富。我們仍然處於非常幸運的地位,能夠透過這些投資幫助癌症患者完成整個治療過程。所以我們正在加速向你所說的方向發展。

  • This Q4 guide implies we hire a number of heads that we're working on hiring. We spend some money on clinical trials that we're hoping to spend and also, we start to scour the landscape for the best breast sales leader. And so all of those things will happen in 2025 are implied in the approximately 25% Q4.

    這份第四季指南暗示我們將招募一些我們正在努力招募的高階主管。我們投入了一些資金用於我們希望能夠進行的臨床試驗,同時,我們也開始在市場上尋找最優秀的乳癌銷售領導者。因此,所有這些事情都將在 2025 年發生,這在第四季度的約 25% 的成長中有所體現。

  • As we have talked about previously, looking ahead, we really do plan on managing to that approximate 25% adjusted EBITDA target going forward. We have a number of tailwinds on the gross margin side next year that we will benefit from, including the full year of the v2 transcriptome. And we have obviously the benefit of no longer having the burn of the French entity.

    正如我們之前討論過的,展望未來,我們確實計劃在未來實現約 25% 的調整後 EBITDA 目標。明年我們在毛利率方面有很多利多因素,我們將從中受益,其中包括 v2 轉錄組全年的應用。而我們顯然也擺脫了法國實體帶來的負面影響。

  • Those will be -- those kind of good guys will be offset by incremental spend on the breast channel, incremental spend on MRD and incremental spend on the Prosigna launch in general and the development to get there. So I think -- think about that 25% is our goal in any given year. And we're going to do our best to manage the P&L to that, and we will be bringing forward spend into 2025 to accomplish this.

    這些——這類好人的支出將被乳房通路的增量支出、MRD 的增量支出以及 Prosigna 的整體上市和相關研發的增量支出所抵消。所以我認為——想想看,25%是我們每年的目標。我們將盡最大努力將損益控制在目標範圍內,並將把部分支出提前到 2025 年來實現這一目標。

  • Operator

    Operator

  • Puneet Souda, Leerink Partners.

    Puneet Souda,Leerink 合夥人。

  • Puneet Souda - Analyst

    Puneet Souda - Analyst

  • I'll try to wrap both of my questions in one, hopefully not too long. On the prostate side, you're well above 25% volume growth for Decipher. My question is, given the penetration that you have today, how should we think about the 2026 growth? Can you still grow more than 20% in volumes here for Decipher in '26?

    我盡量把這兩個問題合併成一個問題,希望不要太長。在前列腺方面,Decipher 的體積增長遠超過 25%。我的問題是,鑑於你們目前的市場滲透率,我們該如何看待 2026 年的成長?Decipher 在 2026 年還能達到 20% 以上的銷售成長嗎?

  • And then on the MRD side, I would love a perspective from Phil and the folks in the room as well. I appreciate you're getting closer to the launch here on MRD. But we have seen data so far from competitors where we have moved from observational trial to not prospective data sets that are getting published in NEJM. We saw the [Tece] data with the IMvigor011 MIBC trial.

    至於 MRD 這邊,我也很想聽聽 Phil 和在座各位的看法。我很高興看到MRD上的發布日期越來越近了。但到目前為止,我們已經從競爭對手那裡看到了數據,他們已經從觀察性試驗轉向了非前瞻性數據集,這些數據集正在《新英格蘭醫學雜誌》上發表。我們在 IMvigor011 MIBC 試驗中看到了 [Tece] 的數據。

  • And there are other data sets that are coming from CRC, lung, other competitors entering the market. So how should we think about Veracyte's MRD position? And more importantly, what's the market strategy here? How do you differentiate? And how do you go to an oncologist and say, here is a test that you ought to employ in your practice, just given the competitive landscape?

    還有其他來自 CRC、肺癌以及其他進入市場的競爭對手的數據集。那我們該如何看待Veracyte的MRD立場呢?更重要的是,這裡的市場策略是什麼?如何區分?鑑於目前的競爭格局,你該如何向腫瘤科醫師說,這是你應該在診療中採用的一種檢測方法?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. Thanks, Puneet. On the first question, let me take that real quick. And I'll actually cover this as a company as a whole, including Afirma and Decipher. You kind of -- this question of durable long-term growth has been a question that we've dealt with for quite a while, understandably.

    是的。謝謝你,普尼特。關於第一個問題,我先快速回答一下。實際上,我將以整個公司為單位進行報道,包括 Afirma 和 Decipher。某種程度上來說——關於可持續長期成長的問題,我們已經處理了相當長一段時間了,這是可以理解的。

  • And if you actually take a look back and look at Afirma has grown year over year for the last 13 quarters. Decipher has grown over 25% in volume for 14 quarters in a row.

    如果你回顧一下,你會發現 Afirma 在過去 13 個季度中逐年成長。Decipher 的交易量已連續 14 個季度成長超過 25%。

  • And if you think about where they both were coming into the year when we looked at the market numbers, Afirma was about -- we had about 1/3 of the TAM and Decipher, we had about 25% of the TAM. So in both cases, there's significant growth opportunity ahead, which is why we've said we feel that the market penetration and market share opportunity and the tailwinds we have and frankly, the lack of headwinds given everything we've done around evidence and NCCN guidelines and so on is what's going to help us get -- comfortably get double-digit growth durably for the foreseeable future, and that includes 2026. So that isn't a concern of mine.

    如果你回顧年初我們查看市場數據時,Afirma 和 Decipher 的市場份額,Afirma 當時大約佔 TAM 的 1/3,而 Decipher 當時約佔 TAM 的 25%。因此,在這兩種情況下,未來都有巨大的成長機會,這就是為什麼我們說,我們認為市場滲透率和市場份額的機會,以及我們所擁有的順風,坦率地說,鑑於我們在證據和 NCCN 指南等方面所做的一切,我們所沒有遇到任何逆風,這將幫助我們在可預見的未來(包括 2026 年)輕鬆實現兩位數的持續增長。所以這不是我擔心的問題。

  • When you actually take those two core ones alone and you get double-digit -- comfortable double-digit growth and you add to that MRD and Prosigna in the nearer term and international and nasal swab in the longer term, you can see we've got a pretty well mapped out.

    當你真正只考慮這兩個核心項目,就能獲得兩位數的增長——穩定的兩位數增長,再加上近期 MRD 和 Prosigna 的發展,以及長期國際市場和鼻拭子檢測的發展,你就會發現我們已經制定了一個相當完善的計劃。

  • Since you brought up MRD on that one, I mean, we've had data published for our MRD test, including in bladder for quite a while. And as I mentioned today, we've got a lot of publications that are in the works. We've talked about UMBRELLA before. We've talked about NEO-BLAST today. I'll let Phil talk about his excitement around some of the clinical studies very, very briefly.

    既然你提到了 MRD,我的意思是,我們的 MRD 檢測數據,包括膀胱檢測數據,已經發表很久了。正如我今天提到的,我們有很多出版物正在籌備中。我們之前討論過雨傘。我們今天討論了NEO-BLAST。我會讓菲爾非常非常簡短地談談他對一些臨床研究的興奮。

  • But essentially, we are very much doing our bit to make sure that we're part of the evidence generation journey.

    但從本質上講,我們正在盡自己的一份力量,確保我們能夠參與證據生成過程。

  • Phillip Febbo - Chief Scientific Officer, Chief Medical Officer

    Phillip Febbo - Chief Scientific Officer, Chief Medical Officer

  • Yes, Puneet, thanks for the question. And I really feel quite confident that between the performance of our test, the strength of our clinical evidence portfolio and our commercial channel, we're going to be a leading competitor in muscle invasive bladder cancer with our MRD test.

    是的,普尼特,謝謝你的提問。我真的非常有信心,憑藉我們檢測的表現、強大的臨床證據組合和商業管道,我們的 MRD 檢測將使我們成為肌肉浸潤性膀胱癌領域的領先競爭者。

  • It's incredibly exciting to see the prospective trials come out like IMvigor011. It was incredible to see the NIAGARA trial to talk about in the neoadjuvant setting. These are foundational trials that are really demonstrating that MRD status is a new disease state and a state that we can take full advantage of the medical oncologist. I'm extremely excited to be able to manage patients more precisely and earlier with a compendium of therapies that are more effective.

    看到像 IMvigor011 這樣的潛在試驗結果出來,真是令人無比興奮。能夠在新輔助治療領域討論 NIAGARA 試驗,真是令人難以置信。這些基礎性試驗真正證明了 MRD 狀態是一種新的疾病狀態,也是我們可以充分利用腫瘤內科醫師的治療狀態。我非常興奮能夠利用一系列更有效的療法,更精準、更早管理患者。

  • We will have to demonstrate with confidence the performance of our tests and I have confidence in our portfolio. What I've seen already, as Marc said, we've already published. We're already in prospective trials. And to cross back to a question that Rebecca had, our clinical trial portfolio will -- we do have opportunities to use some of that margin on our clinical trial portfolio, and we are doing so.

    我們必須自信地證明我們測試的性能,而我對我們的產品組合充滿信心。正如馬克所說,我已經看到了,我們已經發布了。我們已經在進行前瞻性試驗了。回到 Rebecca 提出的問題,我們的臨床試驗組合將——我們確實有機會利用臨床試驗組合中的一些利潤,而我們正在這樣做。

  • Veracyte, I came to Veracyte because of the consistent history of investing in evidence, and this is no exception.

    我選擇加入 Veracyte,是因為他們一貫重視實證投資,而這次也不例外。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • And just one last thing to add to Marc's response on 2026, Puneet, just to sum it all up, we are -- as we're sitting here in our budget planning season, our early look at 2026 revenue is above the Street just to be blunt about it. So we're obviously not guiding today. We'll guide either early in the first quarter at a competitor's conference or shortly thereafter on our Q4 call.

    普尼特,關於馬克對 2026 年的回應,我還有最後一點要補充。總而言之,我們——正值預算規劃季——坦白說,我們對 2026 年收入的初步預測高於華爾街的預期。所以今天我們顯然不提供指導。我們將在第一季初的競爭對手會議上或隨後不久的第四季財報電話會議上給予指導意見。

  • But given the trends we're seeing year to date, quarter to date in Q4, we're extremely excited about 2026 and beyond. And that even is taking into account the around $10 million headwind from biopharma and other revenue that we won't have next year.

    但鑑於我們今年迄今以及第四季迄今所看到的趨勢,我們對 2026 年及以後的發展前景感到非常興奮。而且這還是考慮到了明年我們將失去的來自生物製藥和其他收入的約 1000 萬美元的不利因素。

  • So I think as we're sitting here, the playbook is working, right? What we've invested in is demonstrating the evidence, which is demonstrating the utility, which is demonstrating the guidelines and coverage and growth and penetration.

    所以我覺得,就我們目前的情況來看,這套方案是行之有效的,對吧?我們投入的精力在於證明證據,證明其效用,證明其指導方針、覆蓋範圍、成長和滲透率。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Thanks, Rebecca, thanks Puneet, for the question.

    謝謝Rebecca,謝謝Puneet,你們的問題真棒。

  • Operator

    Operator

  • Kyle Mikson, Canaccord.

    Kyle Mikson,Canaccord。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • Congrats on the awesome quarter. Maybe, Rebecca, on your point there, when you look at the Street estimates for '26, I mean, when you look at like what Decipher is expected to do, what we think Afirma can do, where are people underappreciating Afirma, for example? Just curious what you think about that.

    恭喜你度過了一個非常棒的季度。麗貝卡,關於你剛才提到的這一點,當你查看華爾街對 2026 年的預測時,我的意思是,當你看看 Decipher 的預期表現,以及我們認為 Afirma 能做到的事情時,人們在哪些方面低估了 Afirma 呢?只是好奇你對此有何看法。

  • And then maybe for John or for Phil, the molecular features for Decipher, just could you talk about how much of the unmet need those signatures are and if there's a pipeline beyond PORTOS and PTEN?

    然後,或許對 John 或 Phil 來說,關於 Decipher 的分子特徵,你們能否談談這些特徵滿足了多少未滿足的需求,以及除了 PORTOS 和 PTEN 之外是否還有其他途徑?

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Yes, I'll take the first one. Effectively, the range is pretty wide on each, Kyle. So I don't want to make a statement that's general in nature and have it be expounded or extrapolated into something that is wide in nature.

    是的,我要第一個。實際上,每一項的範圍都相當廣泛,凱爾。所以我不想發表一個籠統的聲明,然後讓它被進一步闡述或推論成範圍很廣的東西。

  • So I would say, in general, we're above the average, but I don't want to go beyond that given I don't have the ranges in my mind for each. So I think the statement can just be applied to the average for both.

    所以總的來說,我認為我們高於平均水平,但考慮到我心中沒有每個人的具體範圍,我不想妄下斷言。所以我認為這個說法可以簡單地應用在兩者的平均值。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • And then we'll let John talk about the commercial opportunity for molecular features and why it's important.

    然後,我們將請約翰談談分子特徵的商業機會及其重要性。

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • Yes. So molecular features are a response to the evidence that's emerging as these collaborative groups use Decipher more and more as a selection enrichment randomization tool. And the evidence from STAMPEDE, from PORTOS, from BALANCE were designed to meet a need in the market, which necessarily is treatment of and management of high-risk and metastatic patients is becoming more and more heterogeneous.

    是的。因此,分子特徵是對不斷湧現的證據的回應,這些合作小組越來越多地使用 Decipher 作為選擇富集隨機化工具。STAMPEDE、PORTOS 和 BALANCE 的證據旨在滿足市場需求,而高風險和轉移性患者的治療和管理必然變得越來越異質化。

  • There are clearly differences in response to a variety of these therapeutics, and so the need for a biomarker is exceptionally high. You can look at the results of those studies to see the benefit of using Decipher in those studies, and we're meeting that need by providing these signatures now in a consolidated report with these predictive biomarkers.

    顯然,不同患者對各種療法的反應存在差異,因此對生物標記的需求非常高。您可以查看這些研究的結果,了解在這些研究中使用 Decipher 的好處,我們現在透過在包含這些預測性生物標記的綜合報告中提供這些特徵來滿足這一需求。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • And Kyle, think of this as a repeatable formula. It's enabled by GRID and whole transcriptome approach. And you'll see us at these signatures when the clinical utility evidence is there and there's an unmet need in our customer base.

    凱爾,把這當作一個可重複使用的公式。這是透過 GRID 和全轉錄組方法實現的。當臨床實用性證據到位,且我們的客戶群存在未被滿足的需求時,您就會在這些簽名儀式上看到我們。

  • Operator

    Operator

  • Lu Li, UBS.

    盧莉,瑞銀。

  • Lu Li - Analyst

    Lu Li - Analyst

  • Congrats on the quarter. First question, I wanted to dig into a little bit on the 2025 guide. It does seem like the Q4 would seem to be roughly flat as of Q3. Any days impact or maybe just like holiday season? Please correct me if I'm wrong on this one.

    恭喜你本季取得佳績。第一個問題,我想深入了解 2025 年的指南。看起來第四季的數據似乎與第三季大致持平。會不會有什麼影響,還是只是像假日?如果我理解有誤,請指正。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • No, it's a great question. So recall, we had $2.5 million of prior period collections in the quarter in Q3, and that isn't necessarily implied in the guide. So that would be one thing.

    不,這是一個很好的問題。所以請記住,我們在第三季有 250 萬美元的前期收款,但這並不一定意味著業績指引中也包含了這筆款項。那算是其中一件事吧。

  • The other thing is the way the holidays do fall is a little bit more challenging than prior years, but those are the two things I would take into consideration. The third thing I would say is we did have a little bit of [French] revenue in Q3 that won't repeat in Q4.

    另外,今年的假期安排比往年更具挑戰性,但以上兩點是我會考慮的因素。第三點是,我們在第三季獲得了一些(法國)收入,但第四季不會再有這樣的收入了。

  • Lu Li - Analyst

    Lu Li - Analyst

  • Got it. Appreciate that. And then I wanted to dig into the breast investment in 2026. Possible that you can size like how big of the channel that you're planning to build? And then also the kind of like the spend related to the Prosigna launch?

    知道了。謝謝。然後,我想深入研究 2026 年的乳房投資情況。是否可以確定您計劃建造的通道有多大?還有,與Prosigna發布相關的支出之類的呢?

  • And then second, also related to kind of the margin question. On Afirma v2, I think it's not fully transitioned yet. I wonder how much of the cost benefit that we've already seen in the quarter? And then how much left that we can potentially see the margin benefit in 2026?

    其次,也與利潤率問題有關。我認為 Afirma v2 還沒有完全過渡。我想知道我們在本季已經看到了多少成本效益?那麼,到 2026 年我們還有多少剩餘的利潤空間可以讓我們看到利潤成長呢?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Thank you for the question. I'll ask John to talk about the commercial scale-up strategy.

    謝謝你的提問。我會請約翰談談商業規模化策略。

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • Yes. Thanks for the question. I mean we're excited about Prosigna. We're excited about in anticipation of the release of the OPTIMA trial results at ASCO 2026 and we're excited about the potential launch. To do that, we will have to build a sales channel specifically focused on breast cancer oncologists.

    是的。謝謝你的提問。我的意思是,我們對Prosigna感到非常興奮。我們非常期待在 2026 年 ASCO 會議上公佈 OPTIMA 試驗結果,並對潛在的上市感到興奮。為此,我們需要建立一個專門針對乳癌腫瘤科醫師的銷售管道。

  • We will do that in a very measured way. It's always been our approach to not get over our skis from a spend standpoint and to build the sales team as we see the demand emerging.

    我們會以非常謹慎的方式進行。我們一直以來的做法是,在支出方面不會操之過急,而是根據市場需求的變化來組成銷售團隊。

  • The plan here is fairly prescriptive. All you got to do is look at how we launched and have led the field in Decipher with prostate cancer to understand how we will approach the market in breast cancer. We will lean into the GRID. We will lean into collaborations with key opinion leaders. We will lean in with buy-in from market leaders on the HCP side and drive the demand from the top down and build the sales team accordingly.

    這裡的計劃相當具體。你只需要看看我們是如何推出 Decipher 並引領攝護腺癌領域的,就能明白我們將如何進入乳癌市場。我們將融入網格系統。我們將加強與關鍵意見領袖的合作。我們將爭取醫療保健專業人士 (HCP) 領域市場領導者的支持,自上而下地推動需求,並據此組建銷售團隊。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Yes. And in terms of the gross margin in the quarter and the v2 transcriptome, so think about the gross margin dynamic on testing as a quarter -- I'm sorry, a month of goodness from the V2 transcriptome for 1/3 of the Afirma volume. Obviously, as we transition throughout Q4, that will -- by the end of Q4, that will go to 100%, but I would really think about that only being at 100% for '26.

    是的。就季度毛利率和 v2 轉錄組而言,請考慮季度測試的毛利率動態——抱歉,V2 轉錄組一個月的收益相當於 Afirma 銷量的 1/3。顯然,隨著我們進入第四季度,到第四季末,這將達到 100%,但我認為到 2026 年才能達到 100%。

  • We also had the benefit of $2.5 million of prior period collections in the quarter. And then we did have a decently sized write-off associated with v1 transcriptome reagents. And so those all kind of netted out with regard to the testing gross margin trends on a sequential basis, if that helps.

    本季我們也受惠於前期收款 250 萬美元。然後,我們確實有一筆與 v1 轉錄組試劑相關的相當大的損失。因此,從環比來看,這些因素對測試毛利率趨勢的影響基本上抵消了,希望這能有所幫助。

  • We're not going to quantify the v2 transcriptome benefit because effectively, it's one of our levers for fueling the investments across the rest of the portfolio and don't want folks to get ahead of themselves on profitability. We will be managing our P&L to that 25% in '26 and beyond, and that gives us ample room given the programs we have in hand to invest for continued revenue growth while also delivering a best-in-class financial profile.

    我們不會量化 v2 轉錄組的好處,因為實際上,它是我們推動投資組合其他部分投資的槓桿之一,我們不希望大家過度關注獲利能力。我們將把 2026 年及以後的損益控制在 25% 以內,鑑於我們手頭上的項目,這給了我們充足的空間進行投資,以實現持續的收入增長,同時還能提供一流的財務狀況。

  • Operator

    Operator

  • Subbu Nambi, Guggenheim.

    蘇布南比,古根漢美術館。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • There have been a lot of updates throughout the year when it comes to competitive landscape for Decipher. In your view, in what ways have things played out as you expected? And what has surprised you the most?

    今年以來,Decipher 的競爭格局發生了許多變化。你認為事情在哪些方面如你所料?最讓你感到驚訝的是什麼?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes, great question, Subbu. Thanks for that. There have been a lot -- and there will continue to be competitive updates, I think. And I think similar to what we talked about for MRD, there's a rising tide here, and we were able to benefit from drafting on others to pave the way for molecular diagnostics in prostate cancer. And through evidence development and having a strong test and ultimately NCCN guidelines, we've been able to benefit from that.

    是的,問得好,Subbu。謝謝。我認為,已經有很多更新——而且未來還會繼續出現更多競爭性的更新。我認為,就像我們之前討論 MRD 一樣,這裡也出現了上升趨勢,我們能夠透過借鑒他人的經驗,為前列腺癌的分子診斷鋪平道路。透過證據的累積、強有力的測試以及最終的 NCCN 指南,我們從中受益匪淺。

  • It's played out maybe better than we thought, frankly. I think Decipher has taken more share than I would have guessed it would coming into the year. And the NCCN guidelines are kind of an unknown quantity. It's hard to quantify the benefit you're going to get from those.

    坦白說,事情的發展可能比我們預想的還要好。我認為 Decipher 的市佔率比我年初預想的要高。而NCCN指南則有點像是未知數。很難量化你能從中獲得的益處。

  • And then obviously, there's been a fair bit of noise around DPAI, and we addressed that question extensively at the beginning, and that's turned out to be a lot of noise and not a lot of substance in terms of the market share and the growth rate that we're seeing in Decipher.

    顯然,圍繞 DPAI 出現了不少噪音,我們在一開始就廣泛地討論了這個問題,但事實證明,這些噪音很多,而就我們在 Decipher 看到的市場份額和增長率而言,並沒有太多實質內容。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • And then do you still expect to have a commercial Prosigna LDT midway through 2026? And if yes, could you provide some color on the time leading up to then? Like what should we expect to see LDT performance data and so on and so forth, I think, the [OPTIMA] data?

    那麼,您是否仍預計在 2026 年中推出商用 Prosigna LDT?如果答案是肯定的,您能否詳細介紹一下先前的情況?例如我們應該期待看到 LDT 效能數據等等,我認為還有 [OPTIMA] 數據?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes, we do expect to have a commercial Prosigna LDT halfway through 2026. You're not going to see a ton of data from us there because we're -- obviously, you've seen the OPTIMA PRELIM data. We're waiting for the final OPTIMA data. That's the key evidence behind that test.

    是的,我們預計在 2026 年中將推出商用 Prosigna LDT。您不會看到我們提供的大量數據,因為——顯然,您已經看到了 OPTIMA PRELIM 數據。我們正在等待最終的 OPTIMA 數據。這是這項測試背後的關鍵證據。

  • And then actually generating that test in our lab is a pretty straightforward process for us with a tech assessment, validation, bridging, New York State approval, all those things, which are fairly normal processes for us to follow.

    然後,在我們實驗室實際產生該測試的過程對我們來說相當簡單,包括技術評估、驗證、橋接、紐約州批准等等,這些都是我們遵循的相當正常的流程。

  • Operator

    Operator

  • Mason Carrico, Stephens.

    梅森·卡里科,史蒂芬斯。

  • Benjamin Mee - Analyst

    Benjamin Mee - Analyst

  • This is Ben on for Mason here. On MRD, would you be able to provide some color on the overlap of urologists that are treating prostate cancer and our Decipher targets and are also those treating muscle invasive bladder cancer that are going to be targets for your MRD assay. What's the overlap here? And really, just what does that Venn diagram look like of those two urologists?

    這裡是本,替梅森報道。關於 MRD,您能否詳細說明一下治療前列腺癌的泌尿科醫生和我們 Decipher 靶點的泌尿科醫生,以及治療肌層浸潤性膀胱癌(這將是你們 MRD 檢測的靶點)的泌尿科醫生之間的重疊情況?兩者之間的重疊之處是什麼?那麼,這兩位泌尿科醫師的維恩圖究竟是什麼樣子的呢?

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • I mean, it's an exceptionally high overlap. Thanks for the question. We expect to be able to serve upwards of 70% of the TAM based on the channels that we currently control. These are primarily going to be a combination of urologists and oncologists. We feel confident we can serve the market.

    我的意思是,重疊部分非常高。謝謝你的提問。我們預計,基於我們目前控制的管道,我們能夠服務超過 70% 的潛在市場。這些醫生主要由泌尿科醫師和腫瘤科醫師組成。我們有信心滿足市場需求。

  • Benjamin Mee - Analyst

    Benjamin Mee - Analyst

  • Okay. Great. And then I appreciate the color that you gave on Decipher's growth in high-risk patients this quarter. Are you able to go a little deeper there and maybe comment on how ordering patterns have trended in localized patients after urologists have adopted the metastatic offering? Is this a fairly immediate impact to orders that you're seeing?

    好的。偉大的。此外,我很欣賞您對 Decipher 本季在高風險患者群體中成長的精彩描述。您能否更深入地探討一下,泌尿科醫師開始提供轉移性疾病治療後,局部性疾病患者的就診模式發生了什麼樣的變化?您觀察到的訂單變化是否相當迅速?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Maybe I'll take that just in terms of stratifying the Decipher market that we're going after. Obviously, we added 30,000 patients when we launched metastatic and now we have the full TAM addressable by Decipher. We also mentioned BCR-based patients, which could be part of the prevalent population, hard to size it, but that's a potential upside. Of course, you've got incidence growth as well.

    也許我會把這看作是對我們所瞄準的 Decipher 市場進行分層的一種方式。顯然,我們在推出轉移性治療時增加了 30,000 名患者,現在 Decipher 可以處理全部 TAM 數據。我們也提到了基於 BCR 的患者,他們可能是流行人群的一部分,很難估計其規模,但這可能是一個優勢。當然,發病率也有所增加。

  • When you kind of subdivide the localized disease population, we've said over 20% in low. So that's actually quite a high penetration for us. We said that the high risk is actually one of our highest growers this quarter, and that's driven a lot by the metastatic data that's come out as well.

    當你把局部疾病族群細分時,我們發現低發生率超過 20%。所以這實際上對我們來說是一個相當高的滲透率。我們說過,高風險實際上是本季成長最快的領域之一,這很大程度上也是由已公佈的轉移性數據推動的。

  • And so while intermediate has always been the highest penetrated and maybe even the highest growing area in the past, it's clear that we are making great traction in every single risk category of prostate cancer patients and metastatic really helped that. And GRID and everything else, NCCN guidelines help that as well.

    因此,雖然中危險群一直是滲透率最高、成長速度最快的人群,但很明顯,我們在前列腺癌患者的每個風險類別中都取得了巨大的進展,而轉移性前列腺癌的治療確實對此有所幫助。GRID 以及其他所有方面,NCCN 指南也對此有所幫助。

  • Operator

    Operator

  • Andrew Brackmann, William Blair.

    安德魯·布拉克曼,威廉·布萊爾。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Maybe just on TrueMRD here. I appreciate all the color on the studies in the pipeline there. But can you maybe just sort of talk about some of the considerations that you have when you sort of think about choosing which indications to expand sort of each year as we sort of look at it, some of those indications are a bit crowded and there's others where Veracyte has a great channel.

    或許只是在 TrueMRD 上。我很欣賞那些正在進行的研究計畫所展現出的豐富多彩的色彩。但是,您能否談談您在考慮每年拓展哪些適應症時會考慮的一些因素?因為我們觀察發現,有些適應症競爭比較激烈,有些適應症則有 Veracyte 的良好管道。

  • And so how do you sort of think about building out that annual road map of additional indications?

    那麼,您是如何考慮制定年度新增適應症路線圖的呢?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes, it's a great question. And Andrew, thanks for referencing our brand, TrueMRD. We're excited about that product. Obviously, we fix muscle invasive bladder cancer for the reasons John just highlighted in terms of the Venn diagram and the overlap there with our existing customer base.

    是的,這是一個很好的問題。Andrew,謝謝你提及我們的品牌 TrueMRD。我們對這款產品感到非常興奮。顯然,我們之所以能夠治療肌肉浸潤性膀胱癌,是因為約翰剛才在維恩圖中強調的原因,以及它與我們現有客戶群的重疊之處。

  • You can imagine us really potentially going after any market with TrueMRD because it is a pan-cancer platform. But we will go after markets where we have an inherent advantage, for example, where we have an existing channel or building a channel.

    您可以想像,TrueMRD 作為一個泛癌平台,我們真的有可能進軍任何市場。但我們會選擇那些我們具有固有優勢的市場,例如,我們已經擁有通路或正在建立通路的市場。

  • It's really great for us to build out the entire care continuum. I think it will really help in MRD to be a company that is able to support that patient and that physician right at the upfront in their diagnostic journey with a prognostic test or a diagnostic test or a predictive test as they're being treated and then an MRD test post treatment.

    對我們來說,建立完整的護理體系真的非常棒。我認為,對於 MRD 檢測而言,一家能夠從一開始就為患者和醫生提供預後測試、診斷測試或預測測試,並在治療期間提供 MRD 測試的公司,將會非常有幫助。

  • And so obviously, covering that whole spectrum there will be an important advantage for us. And then beyond that, it will be subject to things like cohort availability, existing published data that we've already got. We won't shy away from competitive markets. We believe our whole genome-based approach is a differentiator.

    因此,很顯然,覆蓋整個領域對我們來說將是一個重要的優勢。此外,還要取決於隊列的可用性、我們已經掌握的已發布資料等因素。我們不會迴避競爭激烈的市場。我們相信,我們基於全基因組的方法是一項差異化優勢。

  • And so that will certainly -- some markets will be harder to go after than others, especially where they're already well penetrated. And let's face it, most MRD markets are not well penetrated today. So plenty of opportunity. But we won't shy away from it. We'll just be thoughtful about how we do that and the timing.

    因此,某些市場肯定比其他市場更難進入,尤其是在那些市場已經滲透得很深的市場。說實話,目前大多數 MRD 市場滲透率並不高。所以機會很多。但我們不會迴避這個問題。我們會認真考慮如何做以及何時做。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Okay. That's perfect. And then somewhat related to that, another great quarter of cash generation here. So how should we sort of be thinking about your appetite for maybe expanding the portfolio through some acquisitions to maybe round out that care offering?

    好的。那很完美。與此相關的是,本季又迎來了一個強勁的現金流季度。那麼,我們應該如何看待您透過收購來擴大產品組合,從而完善護理服務的可能性呢?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. I mean, absolutely. We've -- I'm very pleased with the performance of the business, especially the cash generation as well this quarter. And as Rebecca said, we're going to -- first and foremost, we look at investing in our business, clinical trials, product development, some of the stuff in infrastructure. We're really building an incredibly efficient engine here at Veracyte, and we have the opportunity to be able to do that.

    是的。我的意思是,當然。我對公司本季的業績,特別是現金流表現,非常滿意。正如麗貝卡所說,我們首先要考慮的是投資我們的業務、臨床試驗、產品開發以及一些基礎設施的事情。在 Veracyte,我們正在打造一款極其高效的引擎,我們有機會做到這一點。

  • M&A, of course, is on the list. And if there's something that makes sense, then we would go after it. But our narrative on this hasn't changed one bit. The funnel isn't huge. We look at everything.

    當然,併購也在其中。如果有什麼合理之處,我們就會去追求。但我們對此事的敘述絲毫沒有改變。漏斗並不大。我們會仔細查看所有方面。

  • We kick the tires, and we're very diligent, and we're not -- this cash doesn't burn a hole in our pockets, far from it. It doesn't change the VC approach that we take. And then beyond that, other capital allocation opportunities, none of which are top of mind for us right now.

    我們仔細檢查過,我們非常勤奮,我們不會——這筆錢不會讓我們破費,恰恰相反。這不會改變我們採取的創投策略。除此之外,還有其他資本配置機會,但目前這些都不是我們要優先考慮的。

  • Anything you want to add, Rebecca?

    麗貝卡,你還有什麼要補充的嗎?

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • No, you covered it quite well.

    不,你已經解釋得很清楚了。

  • Operator

    Operator

  • Andrew Cooper, Raymond James.

    Andrew Cooper,Raymond James。

  • Andrew Cooper - Analyst

    Andrew Cooper - Analyst

  • Maybe first, just one on some of the numbers. I think in the script, you called out a little bit of timing of spend on the 30% EBITDA margin this quarter, but you do have EBITDA up, I think, around $10 million or so at the midpoint. So when you think about those prior plans versus where we are now, what was timing? What was operational performance?

    或許先從一些數字開始。我認為在劇本中,你稍微提到了本季度 30% EBITDA 利潤率的支出時機,但你的 EBITDA 確實有所增長,我認為,中點值約為 1000 萬美元左右。所以,當你回顧之前的計畫和我們現在所處的位置時,時機如何?營運績效如何?

  • And then maybe in the guide, is there any incremental spend that you're pulling in that wasn't expected in '25 in the first place? And how do we think about sort of the jumping off point as we head into next year from an OpEx perspective?

    那麼,在指南中,是否有任何新增支出是您在 2025 年最初沒有預料到的?那麼,從營運支出(OpEx)的角度來看,我們該如何看待明年工作的起點呢?

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Yes, fair question, Andrew. So effectively, what was good news was the revenue outperformance versus our commentary plus prior period collections, which obviously flowed on 100%. I would say there was a little bit of v2 Afirma goodness in there, a little bit further ahead of kind of the transition than we would maybe have expected, though that's a rounding error.

    是的,問得好,安德魯。因此,好消息是收入表現優於我們的預期加上前期收款,顯然實現了 100% 的成長。我認為其中蘊含了一些 v2 Afirma 的優點,比我們預期的過渡階段要領先一些,但這只是個四捨五入的誤差。

  • With regard to the 2025 spend, I would say there -- I wouldn't call it anything specifically material that would fold in. I would say maybe a couple of heads here and there, but we just try to derisk it as much as possible. And the jumping off point for next year, I think you've effectively quantified it decently well.

    至於 2025 年的支出,我想說——我不會稱之為任何具體的、可以納入預算的實質支出。我估計可能會損失幾個人頭,但我們盡量把風險降到最低。至於明年的出發點,我認為你已經相當準確地量化了。

  • You can effectively back into whatever you think the revenue number is with getting to that 25% adjusted EBITDA for 2026.

    只要達到 2026 年 25% 的調整後 EBITDA,你就可以有效地反推你認為的收入數字。

  • Andrew Cooper - Analyst

    Andrew Cooper - Analyst

  • Okay. Helpful. And then already asked, maybe just a little bit more on the Molecular Features Reports. Help us frame how that fits in from a competitive perspective and what you think that can do? Is there any opportunity to kind of go out and monetize that a little bit more directly?

    好的。很有幫助。然後,如同之前有人問到的,能不能再多介紹一下分子特徵報告?請從競爭角度分析這有何意義,以及您認為這能帶來什麼影響?有沒有可能更直接將其變現?

  • How does it compare to something like Promoter Score that you've added on Afirma and what that's helped kind of enable with that platform?

    它與您在 Afirma 上添加的 Promoter Score 等功能相比如何?這些功能為該平台帶來了哪些幫助?

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • Yes. Great question. No, there isn't a way to monetize it directly. But I believe it's yet another way that we continue to improve self-disrupt, add evidence, prove to each one of our HCP customers that they are using the best tool to make the most informed clinical management decision on behalf of their prostate cancer patients. This is just one more thing that we will continue to do.

    是的。問得好。不,目前沒有直接獲利的方法。但我相信,這是我們不斷改進自我顛覆、增加證據、向我們的每一位 HCP 客戶證明他們正在使用最好的工具來代表他們的前列腺癌患者做出最明智的臨床管理決策的另一種方式。這只是我們將繼續做的事情之一。

  • Phillip Febbo - Chief Scientific Officer, Chief Medical Officer

    Phillip Febbo - Chief Scientific Officer, Chief Medical Officer

  • Just to add from a medical perspective, adding these features to our report underscores the value of the biology. And so the treatment of men in that high-risk group and that biochemical occurrence in the metastatic group where we're seeing some very good growth because of our coverage -- recent coverage in metastatic and increased interest in the high risk is getting more complex.

    從醫學角度補充一點,將這些特徵加入我們的報告中,突顯了生物學的價值。因此,對於高危險群中的男性患者以及轉移性人群中出現的生化事件,由於我們的覆蓋範圍——最近對轉移性人群的覆蓋範圍以及對高危險群日益增長的興趣——我們看到了一些非常好的增長,這使得治療變得更加複雜。

  • We have hormonal therapy. We have chemotherapy. We have radiation therapy. We have a whole slew of therapeutics, adding predictive signatures to complement the best-in-class prognostic signature will really help clinicians, urologists as well as some of the radiation therapists and medical oncologists in that space. And so it's part of the Decipher report, but it really helps drive a lot of and inform some of the increasingly complex decisions managing those higher-risk patients.

    我們有荷爾蒙療法。我們接受化療。我們有放射治療。我們擁有一系列治療方法,添加預測特徵來補充一流的預後特徵,將真正幫助臨床醫生、泌尿科醫生以及該領域的一些放射治療師和腫瘤內科醫生。因此,它是 Decipher 報告的一部分,但它確實有助於推動和指導一些日益複雜的決策,這些決策涉及管理這些高風險患者。

  • Operator

    Operator

  • This concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

    問答環節到此結束。感謝您參加今天的會議。節目到此結束。您現在可以斷開連線了。