Veracyte, Inc. (VCYT) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the Veracyte second quarter 2026 financial results webcast. (Operator Instructions). Please be advised that today's conference is being recorded.

    大家好,感謝您稍候。歡迎收看 Veracyte 2026 年第二季財務業績網路直播。(接線員指示)。請注意,今天的會議將被錄音。

  • I would now like to hand the conference over to your speaker today, Kelly Gura, Director of Investor Relations. Please go ahead.

    現在我想把會議交給今天的講者——投資人關係總監 Kelly Gura。請開始。

  • Kelly Gura - Director of Investor Relations

    Kelly Gura - Director of Investor Relations

  • Good afternoon, everyone, and thank you for joining us today to review Veracyte's second quarter 2026 financial results. Joining me on the call are Marc Stapley, our Chief Executive Officer; and Rebecca Chambers, our Chief Financial Officer. Dr. John Leite, our Chief Commercial Officer, will also be available for Q&A.

    各位下午好,感謝大家今天加入我們,一同回顧 Veracyte 2026 年第二季財務業績。與我一同參與電話會議的有我們的執行長 Marc Stapley,以及財務長 Rebecca Chambers。我們的商務長 John Leite 醫師也將出席問答環節。

  • Earlier this afternoon, we issued a press release detailing our second quarter financial results, and we posted an accompanying presentation in the Investors section of our website. 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 that they will prove to be correct. The company undertakes no obligation to update any forward-looking statements, except as required by law. 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.

    今天下午稍早,我們發布了新聞稿,詳述第二季財務業績,並在公司網站「投資人」專區上傳了隨附的簡報。在開始之前,我想提醒各位,我們在本次電話會議中的陳述將包含依適用證券法所定義的前瞻性陳述。前瞻性陳述存在風險與不確定性,公司無法保證其將被證實為正確。除法律要求外,公司不承擔更新任何前瞻性陳述之義務。為更了解可能導致實際結果與預期不同的風險與不確定性,請參閱 Veracyte 向美國證券交易委員會(SEC)提交的文件,包括最新的 10-Q 與 10-K 表格。

  • In addition, this call will include certain non-GAAP financial measures. Reconciliations 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,本次電話會議將包含若干非 GAAP 財務衡量指標。這些指標與最直接可比的 GAAP 財務衡量指標之調節表,已包含於今日的財報新聞稿中,可於 Veracyte 網站「投資人」專區取得。

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

    現在我將把電話會議交給 Veracyte 執行長 Marc Stapley。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Thank you, Kelly, and thank you all for joining us today. Q2 was a milestone quarter for Veracyte as we launched Prosigna LDT and TrueMRD, analyzing two of our key growth opportunities and meaningfully expanding our portfolio. We advanced the clinical evidence supporting Prosigna, Decipher, and Afirma while delivering another quarter of double-digit growth and industry-leading profitability. These achievements reflect years of investment in our platform, the growing body of evidence supporting our tests and our differentiated commercial capabilities.

    謝謝你,Kelly,也感謝各位今天加入我們。第二季對 Veracyte 而言是具里程碑意義的一季,我們推出了 Prosigna LDT 與 TrueMRD,聚焦分析兩項關鍵成長機會,並大幅擴充我們的產品組合。我們推進了支持 Prosigna、Decipher 與 Afirma 的臨床證據,同時再度交出雙位數成長與業界領先的獲利能力。這些成果反映了我們多年來對平台的投資、支持我們檢測的日益累積之證據,以及我們具差異化的商業化能力。

  • More importantly, they enhance our ability to reach and positively impact more patients. Today, our portfolio helps guide patient care across multiple cancer types and increasingly across the cancer care continuum from risk assessment through recurrence monitoring. As we continue to expand that impact, we are approaching one of the most meaningful milestones in our company's history, serving our 1 millionth patient.

    更重要的是,這些成果提升了我們觸及並為更多病患帶來正向影響的能力。如今,我們的產品組合可在多種癌症類型中協助指引病患照護,並且愈來愈多地涵蓋癌症照護的全流程,從風險評估到復發監測。在我們持續擴大影響力之際,我們也正接近公司歷史上最具意義的里程碑之一——服務第 100 萬位病患。

  • The recent launches of Prosigna LDT and TrueMRD for muscle invasive bladder cancer, or MIBC, represent the culmination of years of hard work. To say I'm proud of these accomplishments and of our team for delivering them would be an understatement.

    近期推出的 Prosigna LDT 與針對肌層浸潤性膀胱癌(muscle invasive bladder cancer,MIBC)的 TrueMRD,是多年努力的結晶。若要說我為這些成就以及我們團隊能夠交付成果而感到自豪,那仍不足以形容。

  • I want to thank our employees and external collaborators whose expertise and partnership made these outcomes possible. I'm also grateful to the physicians who have worked with us to advance cancer care and to the many thousands of patients whose participation in research helped make these innovations possible.

    我要感謝我們的員工與外部合作夥伴,正是他們的專業與合作讓這些成果得以實現。我也感謝與我們一同推進癌症照護的醫師們,以及數以千計參與研究的病患,正是他們的參與讓這些創新成為可能。

  • Since launching the Prosigna test in the US following the presentation of the practice-changing OPTIMA trial results at ASCO, we've seen tremendous enthusiasm from both physicians and patients. Prosigna helps guide treatment decisions at a pivotal point in the breast cancer care journey by quantifying the risk of recurrence up to 10 years and providing a likelihood of chemotherapy benefit.

    自從在 ASCO 發表可改變臨床實務的 OPTIMA 試驗結果後,我們在美國推出 Prosigna 檢測以來,已看到醫師與病患雙方都展現出極大的熱忱。Prosigna 透過量化長達 10 年的復發風險並提供化療獲益的可能性,在乳癌照護旅程的關鍵節點協助指引治療決策。

  • Backed by the most rigorous clinical trial demonstration to date, Prosigna achieves this by providing intrinsic subtype and classification information from the well-validated, well-published PAM50 signature that highlights the underlying biology driving the patient's cancer. This helps identify patients who can benefit from chemotherapy and those who may be able to safely avoid it. Prosigna is foundational to our breast cancer franchise and represents one of the most significant product launches in Veracyte's history.

    在迄今最嚴謹的臨床試驗驗證支持下,Prosigna 透過提供內在亞型與分類資訊來達成上述目的;這些資訊源自已充分驗證且廣泛發表的 PAM50 特徵(signature),可凸顯驅動病患癌症的基礎生物學機制。這有助於辨識哪些病患可從化療中受益,以及哪些病患可能可以安全地避免化療。Prosigna 是我們乳癌產品線的基石,也是 Veracyte 歷史上最重要的產品上市之一。

  • As a reminder, OPTIMA is an independent prospective Phase III randomized trial that enrolled more than 4,400 high-risk early-stage breast cancer patients. The study met its primary endpoint and demonstrated that more than two-thirds of clinically high-risk patients may safely avoid chemotherapy without compromising outcomes. Importantly, this includes premenopausal women and patients with up to nine positive lymph nodes.

    提醒各位,OPTIMA 是一項獨立的前瞻性第三期隨機試驗,納入超過 4,400 名高風險早期乳癌病患。該研究達成其主要終點,並顯示超過三分之二臨床上屬高風險的病患可在不影響預後的情況下安全避免化療。重要的是,這包括停經前女性以及最多有 9 顆淋巴結陽性的病患。

  • The OPTIMA results also generated significant media retention, making OPTIMA and Prosigna the most covered diagnostic story at ASCO. Looking ahead, publication in a leading peer-reviewed journal will represent another important milestone, further validating this Level 1A prospective evidence supporting Prosigna and its potential inclusion in future clinical guidelines.

    OPTIMA 的結果也獲得大量媒體關注,使 OPTIMA 與 Prosigna 成為 ASCO 報導最多的診斷相關故事。展望未來,若能在頂尖的同儕審查期刊發表,將是另一項重要里程碑,進一步驗證支持 Prosigna 的 Level 1A 前瞻性證據,並提升其未來納入臨床指引的可能性。

  • We see a significant opportunity to expand access to Prosigna in the US, where approximately 225,000 patients are diagnosed with ER-positive HER2-negative breast cancer each year. We believe many of these patients may benefit from the clinically validated insights Prosigna provides to help inform treatment decisions.

    我們看到在美國擴大 Prosigna 可近性的重大機會;美國每年約有 225,000 名病患被診斷為 ER 陽性、HER2 陰性乳癌。我們相信,其中許多病患可受益於 Prosigna 所提供、經臨床驗證的洞見,以協助治療決策。

  • With OPTIMA, Prosigna has the only clinically validated evidence for premenopausal women in patients with higher nodal involvement. This expands and strengthens the clinical utility already demonstrated in many prior studies, including as a prognostic test for node-negative patients. There are 157 publications to date featuring Prosigna and more than 1,200 publications featuring the PAM50 classifier on which the test was built.

    透過 OPTIMA,Prosigna 擁有針對停經前女性以及淋巴結受累程度較高病患的唯一臨床驗證證據。這擴大並強化了先前多項研究已證實的臨床效用,包括作為淋巴結陰性病患的預後檢測。截至目前,已有 157 篇文獻發表涉及 Prosigna,且已有超過 1,200 篇文獻發表涉及作為該檢測基礎的 PAM50 分類器。

  • In the near term, we are focused on educating key opinion leaders and driving adoption in high-volume centers. While menopausal status and nodal involvement may present a catalyst for the initial conversation, we believe health care providers will choose a test they can use with confidence across all ER-positive HER2-negative patients rather than stratifying their use based on these differentiating factors alone.

    短期內,我們聚焦於教育關鍵意見領袖,並推動在高量能中心的採用。雖然停經狀態與淋巴結受累可能成為初期對話的催化因素,但我們相信醫療照護提供者會選擇一項能夠在所有 ER 陽性、HER2 陰性病患中都可安心使用的檢測,而不是僅依這些差異化因素來分層使用。

  • We have been thrilled by the quality and breadth of engagement since launch, which gives us confidence our commercial strategy is on point. We are now actively engaged with more than 100 institutions that help shape standards of care in breast cancer, including nationally recognized academic cancer centers, large integrated health systems, and regional oncology networks.

    自上市以來,我們對互動的品質與廣度感到非常振奮,這讓我們對商業策略的精準性更具信心。目前我們已與超過 100 家有助於形塑乳癌照護標準的機構積極互動,其中包括全國知名的學術癌症中心、大型整合式醫療體系,以及區域腫瘤醫療網絡。

  • Many of these organizations are evaluating broad adoption of Prosigna across their breast cancer programs and in some cases, have expressed interest in using Prosigna for all hormone receptor positive patients that they treat.

    其中許多組織正在評估在其乳癌計畫中廣泛採用 Prosigna;在某些情況下,他們也表達了希望對其治療的所有荷爾蒙受體陽性病患使用 Prosigna 的意願。

  • Based on this strong engagement, the growing activity on our ordering platform and our customers' desire to start incorporating Prosigna into existing practice management workflows, we are expanding our sales force ahead of our original plan to capture the demand we are seeing. We are making progress on reimbursement and continue to have constructive discussions with MolDX regarding Medicare coverage.

    基於這些強勁的互動、我們下單平台上日益增加的活動,以及客戶希望開始將 Prosigna 納入既有臨床作業管理流程的需求,我們正提前於原先計畫擴編銷售團隊,以掌握我們所看到的需求。我們在給付方面持續取得進展,並且仍與 MolDX 就 Medicare 覆蓋範圍進行具建設性的討論。

  • We are encouraged by the engagement to date and look forward to providing updates as those discussions progress. I couldn't be more excited about the momentum we have seen since launch. While early, the response from patients, clinicians, key opinion leaders, and the broader oncology community reinforces our conviction that Prosigna can become a meaningful growth driver for Veracyte and even more importantly, improve quality of life for the hundreds of thousands of patients dealing with breast cancer.

    我們對迄今為止的互動參與感到鼓舞,並期待隨著這些討論的推進提供最新進展。自上市以來我們所看到的動能,讓我感到無比振奮。儘管仍處於早期階段,來自患者、臨床醫師、關鍵意見領袖以及更廣泛腫瘤學社群的回饋,進一步強化了我們的信念:Prosigna 有望成為 Veracyte 具意義的成長驅動力,更重要的是,能改善數十萬名正面對乳癌的患者之生活品質。

  • Turning now to MRD. We launched our first test on our TrueMRD platform in June after securing Medicare reimbursement for recurrence monitoring in patients with MIBC following radical cystectomy. The two MRD monitoring test for MIBC represents the first commercial application of our MRD platform and our entry into this rapidly growing market. Importantly, our whole genome approach to MRD is extensible, well beyond bladder cancer with the potential to support multiple tumor types and clinical applications over time.

    接下來談 MRD。在取得 Medicare 對接受根治性膀胱切除術後之 MIBC 患者復發監測的給付後,我們於 6 月在 TrueMRD 平台上推出了第一項檢測。針對 MIBC 的兩項 MRD 監測檢測,代表我們 MRD 平台的首個商業化應用,也標誌著我們進入這個快速成長的市場。重要的是,我們以全基因組為基礎的 MRD 方法具可延展性,遠不僅限於膀胱癌,並有潛力隨時間推進支援多種腫瘤類型與臨床應用。

  • TrueMRD for MIBC is the first and only commercially available MRD test to utilize whole genome sequencing for not just the landmark test, but also through longitudinal monitoring with all subsequent liquid biopsy surveillance tests.

    TrueMRD for MIBC 是第一個也是唯一一個商業可用的 MRD 檢測,不僅在基準(landmark)檢測中使用全基因組定序,也在後續所有液體活檢監測檢測的縱向追蹤中持續採用全基因組定序。

  • We believe this is a meaningful differentiator, offering a broader view of tumor biology and the ability to track tumor evolution over time, capabilities we expect will become increasingly important as oncology research and testing advances.

    我們相信這是一項具意義的差異化優勢,能提供對腫瘤生物學更全面的視角,並具備隨時間追蹤腫瘤演化的能力;隨著腫瘤學研究與檢測的進步,我們預期這些能力將變得愈發重要。

  • More broadly, we believe Veracyte is uniquely positioned to serve patients across the bladder cancer continuum. Today, Decipher Bladder helps physicians risk stratify patients. And with TrueMRD for MIBC, we are adding recurrence monitoring at another critical point in the patient journey.

    更廣泛而言,我們相信 Veracyte 具備獨特優勢,可在膀胱癌照護的全病程中服務患者。目前,Decipher Bladder 協助醫師對患者進行風險分層。而透過 TrueMRD for MIBC,我們在患者旅程的另一個關鍵節點新增了復發監測。

  • Over time, we expect continued evidence generation, product enhancements, and portfolio expansion to further strengthen our position in bladder cancer management. We are leveraging the strong brand we have built through Decipher and our long-standing relationships across urology and radiation oncology to accelerate awareness and adoption of our first TrueMRD test.

    隨著時間推進,我們預期持續的證據產出、產品強化與產品組合擴張,將進一步鞏固我們在膀胱癌管理領域的地位。我們正運用透過 Decipher 建立的強大品牌,以及我們在泌尿科與放射腫瘤科長期累積的關係網絡,加速市場對我們首個 TrueMRD 檢測的認知與採用。

  • In parallel, we are investing in the operational infrastructure, workflow enhancements and automation needed to support larger testing volumes as we intentionally expand the platform over time. While we remain in the early stages of commercialization of TrueMRD for MIBC, we have been encouraged by the initial feedback from physicians who recognize the advantages of a truly whole genome approach and the complementarity to our overall bladder program. We continue to believe that the TrueMRD platform has the potential to become an important long-term growth driver for Veracyte.

    同時,我們也投資於營運基礎設施、流程優化與自動化,以支援隨著平台有計畫地逐步擴張而帶來的更大檢測量。儘管 TrueMRD for MIBC 的商業化仍處於早期階段,我們對初期醫師回饋感到鼓舞;他們認可真正全基因組方法的優勢,以及其與我們整體膀胱癌方案的互補性。我們仍然相信 TrueMRD 平台有潛力成為 Veracyte 重要的長期成長驅動力。

  • Moving on to Decipher Prostate. We delivered another strong quarter of revenue growth, up 20% year over year, driven primarily by 17% volume growth with improved ASP contributing the balance. ASP growth reflects the significant focused work our market access and billing teams completed over the last year, including operational improvements, strong payer engagement, and expanded coverage across multiple accounts, which led to higher recoveries per test.

    接著談 Decipher Prostate。我們再度交出強勁的一季營收成長,年增 20%,主要由 17% 的檢測量成長所帶動,ASP 的改善貢獻其餘部分。ASP 的成長反映了我們市場准入與帳務團隊在過去一年完成的大量聚焦工作,包括營運改善、與付款方的深度互動,以及在多個帳戶擴大給付覆蓋,進而提升每次檢測的回收金額。

  • With just under 30,000 tests resulted in the second quarter, we continue to see strong underlying demand for Decipher. Having said that, we are taking our expectations for volume for the year down by approximately 1% or slightly more than 1,000 tests, primarily in the low-risk setting. Importantly, our expectations for the rest of the business remain on track.

    第二季出具結果的檢測量接近 30,000 例,我們持續看到 Decipher 強勁的基本需求。儘管如此,我們將全年檢測量預期下調約 1%(或略高於 1,000 例),主要發生在低風險情境。重要的是,我們對其餘業務的預期仍維持在既定軌道上。

  • Low-risk disease represents an important growth opportunity for Decipher and one where we are also actively investing to generate additional high-quality evidence. The 2025 NCCN guideline update reinforced the need for additional high-quality evidence supporting the use of genomic testing in low-risk patients considering active surveillance. We have a growing clinical data pipeline that we believe will address this unmet need with several prospective and retrospective studies underway evaluating Decipher in active surveillance and low-risk patient populations with initial readouts as early as 2027. As these data emerge, we believe they have the potential to further expand the clinical foundation for Decipher, supporting broader low-risk adoption and guideline inclusion over time.

    低風險疾病是 Decipher 一項重要的成長機會,我們也正積極投資以產出更多高品質證據。2025 年 NCCN 指南更新強調:對於考慮主動監測的低風險患者,仍需要更多支持基因體檢測使用的高品質證據。我們擁有持續擴大的臨床資料管線,透過多項前瞻性與回溯性研究(目前正在進行中)評估 Decipher 在主動監測與低風險患者族群中的表現;最早可望於 2027 年取得初步讀出結果。隨著這些資料逐步出爐,我們相信其有潛力進一步擴充 Decipher 的臨床基礎,並隨時間推進支持更廣泛的低風險採用與納入指南。

  • Turning to the balance of the Decipher business, which grew approximately 20% in Q2 '26 off of a challenging prior year comp. Recall that Q2 2025 benefited from the initial step-up in testing following the 2024 NCCN guideline updates made late in the year, which reflected Decipher's position as the only gene expression test supported by high-quality evidence. That step-up has proved durable and the underlying order trends this quarter give us confidence that the Decipher business is on a consistent trajectory of growth.

    再看 Decipher 其餘業務,在 2026 年第二季於前一年高基期的情況下仍成長約 20%。回顧 2025 年第二季,受惠於 2024 年末發布的 NCCN 指南更新後檢測量的首次躍升,該更新反映 Decipher 作為唯一有高品質證據支持的基因表現檢測之地位。這一波躍升已證明具有持續性,而本季的基礎訂單趨勢也讓我們有信心:Decipher 業務正沿著一致的成長軌跡前進。

  • For example, in Q2, we delivered our highest sequential volume growth since that exceptional quarter last year. This growth was driven by both a strong increase in new ordering positions and deeper penetration within our existing base. Orders per physician reached a new record, reflecting broader Decipher use by our core physician base across more of their patients. Together, these trends show that physicians are increasingly relying on Decipher to provide critical information that helps guide treatment decisions for patients with prostate cancer across risk groups.

    例如,在第二季,我們達成自去年那個非凡季度以來最高的季對季檢測量成長。此成長同時來自新增下單據點的強勁增加,以及在既有客戶基礎中的更深度滲透。每位醫師的下單量創下新高,反映我們核心醫師群在其更多患者中更廣泛地使用 Decipher。綜合而言,這些趨勢顯示醫師愈來愈依賴 Decipher 提供關鍵資訊,以協助跨不同風險分群的前列腺癌患者做出治療決策。

  • We were particularly encouraged by strong ordering trends in intermediate and high-risk localized disease as well as post-prostatectomy and biochemical recurrence. These remain some of the largest and most attractive growth opportunities for Decipher, reflecting areas where the clinical evidence base is strongest, guideline support is uniquely established, and physician adoption continues to deepen. More broadly, evidence generation remains robust across these settings as well as the metastatic setting, a critical component to ensuring continued adoption and long-term growth.

    我們尤其受到鼓舞的是:在中風險與高風險局部疾病,以及前列腺切除術後與生化復發等領域,訂單趨勢表現強勁。這些仍是 Decipher 最大且最具吸引力的成長機會之一,反映其臨床證據基礎最為扎實、指南支持具獨特性且已建立,以及醫師採用持續加深的領域。更廣泛而言,無論在上述情境或轉移性疾病情境中,證據產出仍然強勁,這是確保持續採用與長期成長的關鍵要素。

  • During the quarter, Decipher Prostate was featured in more than 35 publications and abstracts, including Level 1b evidence from the EZAMET trial presented at ASCO. This study provided new predictive evidence supporting Decipher Prostate to help inform use of triplet therapy in metastatic prostate cancer, identifying patients most likely to benefit from the addition of chemotherapy to standard doublet hormone therapy.

    本季度,Decipher Prostate 出現在超過 35 篇論文與摘要中,其中包括在 ASCO 發表、來自 EZAMET 試驗的 1b 級證據。該研究提供新的預測性證據,支持使用 Decipher Prostate 以協助判斷在轉移性前列腺癌中採用三聯療法,並辨識最可能從在標準雙聯荷爾蒙治療上加用化療中獲益的患者。

  • Looking ahead, we are excited about the steady drumbeat of upcoming conference presentations in the second half of the year. At ASCO in September, Deciphera is expected to be featured in six oral presentations, including three focused on treatment intensification with androgen deprivation therapy, or ADT, a key area of clinical decision-making in intermediate risk and post-RP biochemical recurrent prostate cancer. We are particularly excited about upcoming analyses from NRG-RTOG 0815, which we believe have the potential to further establish Decipher's role in personalizing treatment with radiation and ADT for intermediate risk prostate cancer patients, our largest indication.

    展望未來,我們對下半年即將密集登場的會議發表感到振奮。在 9 月的 ASCO,預期 Deciphera 將出現在 6 場口頭報告中,其中 3 場聚焦於以雄激素剝奪治療(ADT)進行治療強化;這是中風險與根治性前列腺切除術後生化復發前列腺癌中臨床決策的關鍵領域。我們也特別期待 NRG-RTOG 0815 的即將發布分析;我們相信其有潛力進一步確立 Decipher 在以放射治療與 ADT 為中風險前列腺癌患者(我們最大的適應症)進行個人化治療中的角色。

  • We're also looking forward to results from the SPORT trial, evaluating whether PAM50based subtyping can provide additional clinically useful information in prostate cancer. Together with additional data expected at ESMO later this year supporting Decipher's utility in high-risk disease, these presentations represent additional data, expanding the clinical utility of our tests across the prostate cancer continuum.

    我們也期待 SPORT 試驗的結果,該試驗評估以 PAM50 為基礎的分型是否能在前列腺癌中提供額外且具臨床價值的資訊。再加上預期於今年稍晚在 ESMO 發表、支持 Decipher 在高風險疾病中效用的更多資料,這些報告將帶來額外數據,擴展我們檢測在前列腺癌全病程中的臨床效用。

  • Beyond prostate cancer, we saw encouraging Q2 order trends for Decipher Bladder, which helps physicians risk stratify patients with muscle invasive as well as non-muscle invasive disease and guide treatment decisions. The test was featured in 13 publications and abstracts in Q2, including six abstracts at AUA and more expected later this year at ESMO, highlighting our growing body of evidence across the bladder cancer continuum.

    除了前列腺癌之外,我們也看到 Decipher Bladder 在第二季出現令人鼓舞的訂單趨勢;該檢測可協助醫師對肌肉浸潤性以及非肌肉浸潤性疾病患者進行風險分層,並指引治療決策。該檢測在第二季共有 13 篇出版物與摘要中被重點呈現,其中包括在 AUA 的 6 篇摘要,且預期今年稍晚在 ESMO 還會有更多,凸顯我們在膀胱癌全病程中日益擴大的證據基礎。

  • Looking ahead, we remain highly confident in Decipher's long-term growth opportunity, supported by expansion of our customer base, durable and broader physician adoption, and expanding body of clinical and real-world evidence, including multiple important study readouts expected over the next few years and continued innovation across our platform.

    展望未來,我們對 Decipher 的長期成長機會仍然非常有信心,這得益於客戶基礎的擴張、醫師採用的持久性與更廣泛的滲透,以及不斷擴大的臨床與真實世界證據,包括未來幾年預期將公布的多項重要研究讀出結果,以及我們平台上的持續創新。

  • Turning now to Afirma. We delivered another strong quarter with approximately 18,600 tests, representing 10% year-over-year volume growth and 18% revenue growth. We were pleased to see another quarter of increased utilization among existing physicians, continued expansion of our ordering physician base, and ongoing market share gains, reinforcing Afirma's position as the market leader in thyroid nodule molecular diagnostics.

    接下來談 Afirma。我們再度交出強勁的一季,檢測量約 18,600 例,代表年增 10% 的量成長與 18% 的營收成長。我們很高興看到既有醫師的使用率再度提升、開立檢測的醫師基礎持續擴大,以及市占率持續提升,進一步鞏固 Afirma 作為甲狀腺結節分子診斷市場領導者的地位。

  • Revenue growth benefited from both sustained ASP gains and favorable reimbursement wins from commercial payers. We also continue to realize the benefits of our B2 transcriptome workflow, which has improved our no result rate significantly, resulting in more patients receiving a test result and contributing to approximately 400 basis points of volume growth in the quarter.

    營收成長同時受惠於 ASP(平均售價)的持續提升,以及來自商業保險支付方的有利給付(reimbursement)勝利。我們也持續實現 B2 轉錄體(transcriptome)工作流程帶來的效益,顯著改善無結果率(no result rate),使更多患者能收到檢測結果,並在本季貢獻約 400 個基點的量成長。

  • Evidence generation remains a key component of the Afirma growth strategy as it does for all of our tests. Afirma was featured in 10 conference abstracts during the quarter across leading medical meetings, including the American Association of Endocrine Surgeons, American Association of Clinical Endocrinology, and the Endocrine Society. Multiple peer-reviewed manuscripts were published during the quarter and growing interest from independent investigators evaluating Afirma's clinical utility in real-world practice continues to be a competitive differentiation.

    證據生成仍是 Afirma 成長策略的關鍵組成,這點與我們所有檢測一致。本季 Afirma 在多個頂尖醫學會議共 10 篇會議摘要中被重點呈現,包括美國內分泌外科醫師協會(American Association of Endocrine Surgeons)、美國臨床內分泌學會(American Association of Clinical Endocrinology)以及內分泌學會(Endocrine Society)。本季也發表了多篇同儕審查(peer-reviewed)論文,且獨立研究者在真實世界臨床實務中評估 Afirma 臨床效用的興趣日益增加,持續成為我們的競爭差異化優勢。

  • We are encouraged by the growing momentum behind Afirma Grid, which is supporting an expanding pipeline of academic and industry collaborations. These grid collaborations fuel a virtuous cycle of expanding evidence leading to new publications, scientific presentations, and molecular insights that will continue to strengthen the evidence base around Afirma. We expect to see more Afirma publications and scientific abstracts this year than in 2025, further accelerating that momentum.

    我們對 Afirma Grid 背後日益增長的動能感到振奮,該計畫正支持不斷擴大的學術與產業合作管線。這些 Grid 合作推動一個良性循環:證據擴增帶來新的出版物、科學發表與分子層面的洞見,將持續強化 Afirma 的證據基礎。我們預期今年 Afirma 的出版物與科學摘要數量將高於 2025 年,進一步加速這股動能。

  • Overall, we remain very pleased with Afirma's performance and believe the combination of continued adoption, share gains, operational improvements, and expanding clinical evidence positions the franchise for continued growth.

    整體而言,我們仍對 Afirma 的表現非常滿意,並相信持續採用、份額提升、營運改善與臨床證據擴增的組合,將使該產品線具備持續成長的有利定位。

  • In closing, seeing years of investment and innovation translate into meaningful new opportunities for growth is incredibly rewarding and a testament to the strength of our strategy, our execution, and most importantly, our people.

    最後,看到多年投資與創新轉化為具意義的全新成長機會,令人倍感欣慰,這也證明了我們策略的強度、執行力,以及最重要的——我們的團隊。

  • Our mission remains centered on improving patient outcomes. And today, our portfolio is helping clinicians and patients make more informed treatment decisions across multiple cancer types and increasingly across the cancer care continuum. Supported by the continued strength of our core franchises, a robust pipeline of clinical evidence, and multiple opportunities for future innovation, we remain confident in our ability to continue to deliver durable double-digit growth for the foreseeable future.

    我們的使命始終以改善患者預後為核心。而今天,我們的產品組合正協助臨床醫師與患者在多種癌症類型上做出更有依據的治療決策,並且愈來愈多地涵蓋癌症照護的全病程。在核心產品線持續強勁、臨床證據管線穩健,以及多項未來創新機會的支持下,我們仍有信心在可預見的未來持續交付穩健的兩位數成長。

  • With that, I'll turn the call over to Rebecca.

    接下來,我把電話會議交給 Rebecca。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Thanks, Marc. We delivered total revenue of $150.3 million in the second quarter, representing 15% year-over-year growth. Total volume increased to approximately 51,000 tests, up 13% compared to the same period in 2025. And we generated $45.8 million of cash from operations, ending the quarter with $485.2 million in cash, cash equivalents, and short-term investments. Testing revenue for the quarter was $145.7 million, an increase of 19% year over year, driven by Decipher and Afirma growth of 20% and 18%, respectively. Total testing volume was 48,389 tests, representing 14% year-over-year growth.

    謝謝,Marc。我們第二季總營收為 1.503 億美元,年增 15%。總檢測量增加至約 51,000 例,較 2025 年同期成長 13%。我們也從營運活動產生 4,580 萬美元現金,季末現金、約當現金與短期投資合計為 4.852 億美元。本季檢測營收為 1.457 億美元,年增 19%,主要由 Decipher 與 Afirma 分別 20% 與 18% 的成長所帶動。總檢測量為 48,389 例,代表年增 14%。

  • Testing ASP was $3,010, up 4% to the prior year and inclusive of approximately $4.5 million of prior period collections or PTCs.

    檢測 ASP 為 3,010 美元,較去年提升 4%,並包含約 450 萬美元的前期期間收款(prior period collections,PTCs)。

  • Excluding PTCs, normalized ASP increased 3% to approximately $2,900, driven by the benefits of operational efforts put into place over the course of 2025, which have led to sustained pricing gains in the first half of this year.

    排除 PTCs 後,常態化 ASP 年增 3% 至約 2,900 美元,主要受惠於我們在 2025 年期間推動的營運措施,這些措施在今年上半年帶來了持續的定價提升。

  • Turning to gross margin and operating expenses, I'll focus on our non-GAAP results. Non-GAAP gross margin was 74.9%, up 340 basis points year over year, driven by strength in our testing business. Testing gross margin increased 200 basis points to 76%, reflecting operational efficiencies from our V2 transcriptome workflow, higher ASP and PTCs.

    接著談毛利率與營運費用,我將聚焦於我們的非 GAAP 結果。非 GAAP 毛利率為 74.9%,年增 340 個基點,主要由檢測業務的強勁表現所帶動。檢測毛利率提升 200 個基點至 76%,反映 V2 轉錄體工作流程帶來的營運效率、較高的 ASP 以及 PTCs。

  • Non-GAAP operating expenses increased 16% year over year to $70 million. As we shared last quarter, certain IT expenses associated with software development and project management resources previously reported in G&A have been moved directly into R&D as they are fully dedicated to our product development objectives.

    非 GAAP 營運費用年增 16% 至 7,000 萬美元。如同我們上季所分享,先前列在 G&A 的部分 IT 費用(與軟體開發及專案管理資源相關)已直接移轉至研發(R&D),因其完全投入於我們的產品開發目標。

  • As a result, R&D expense increased $12.1 million year over year to $26.3 million, approximately half of which were driven by our organizational changes and the other half driven by increased clinical and product investment. Sales and marketing expense increased $2.4 million to $25.5 million, reflecting hiring to support our existing portfolio as well as the recent launches of Prosigna LDT and TrueMRD. G&A expense decreased $4.8 million to $18.1 million, primarily due to the organizational changes previously mentioned.

    因此,研發費用年增 1,210 萬美元至 2,630 萬美元,其中約一半來自組織調整,另一半來自臨床與產品投資增加。銷售與行銷費用增加 240 萬美元至 2,550 萬美元,反映為支持既有產品組合以及近期推出的 Prosigna LDT 與 TrueMRD 而進行的人才招募。G&A 費用下降 480 萬美元至 1,810 萬美元,主要由前述組織調整所致。

  • From a profitability standpoint, we delivered GAAP net income of $25.5 million in the quarter. Adjusted EBITDA was $44 million or 29.2% of revenue, up 23% year over year and above our long-term target of 25%. This level of profitability continues to demonstrate our operating leverage as we both invest in our growth drivers and generate meaningful cash.

    就獲利而言,我們本季 GAAP 淨利為 2,550 萬美元。調整後 EBITDA 為 4,400 萬美元,或占營收 29.2%,年增 23%,並高於我們 25% 的長期目標。這樣的獲利水準持續展現我們的營運槓桿:我們一方面投資於成長驅動因素,同時也產生可觀的現金。

  • Turning to our 2026 outlook. We are raising full year total revenue guidance to $590 million to $596 million, representing 14% to 15% year-over-year growth compared to our prior range of $582 million to $592 million. This reflects expected testing revenue of $576 million to $582 million, representing 17% to 18% year-over-year growth compared to our prior range of $570 million to $580 million, with testing volume growth modestly below revenue. Included in our guidance is approximately $10 million of other testing revenue from cytology services and Decipher Bladder.

    接著談我們對 2026 年的展望。我們上調全年總營收指引至 5.90 億至 5.96 億美元,代表年增 14% 至 15%,相較於先前 5.82 億至 5.92 億美元的區間。這反映預期檢測營收為 5.76 億至 5.82 億美元,代表年增 17% 至 18%,相較於先前 5.70 億至 5.80 億美元的區間,且檢測量成長將略低於營收成長。我們的指引亦包含約 1,000 萬美元的其他檢測營收,來自細胞學(cytology)服務與 Decipher Bladder。

  • Further, our guidance assumes approximately 20% Decipher revenue growth. Based on current ordering trends and normal seasonality, we expect approximately 31,000 tests in Q3 and 33,000 in Q4. And given PPCs collected year-to-date and stronger-than-expected ASP performance this year, we now expect ASP to be slightly higher this year compared to 2025.

    此外,我們的指引假設 Decipher 營收約成長 20%。根據目前的訂單趨勢與正常季節性,我們預期第三季約 31,000 例檢測、第四季約 33,000 例檢測。並且考量到年初至今已收取的 PPC,以及今年 ASP 表現優於預期,我們現在預期今年的 ASP 將較 2025 年略高。

  • For Afirma, we have increased our revenue guidance to approximately 12% to 14% year-over-year growth, driven by favorable year-to-date PPCs, ongoing ASP improvement, and an anticipated no result rate benefit of approximately 3% for the year. Due to typical seasonality and in line with prior years, we expect Q3 volume to be slightly down sequentially with a larger step-up in Q4. On revenue, Afirma is expected to step down sequentially given close to $3 million of PTCs in the second quarter.

    就 Afirma 而言,我們已將營收指引上調至年增約 12% 至 14%,主要受惠於年初至今有利的 PPC、ASP 持續改善,以及預期全年約 3% 的「無結果率」改善效益。由於典型季節性且與往年一致,我們預期第三季量能將較前一季略降,而第四季將有較大幅度的回升。在營收方面,由於第二季約有接近 300 萬美元的 PTC,Afirma 的營收預期將較前一季下滑。

  • As Marc shared, we are pleased with the early feedback on our recently launched tests. Given we do not yet have Medicare reimbursement for Prosigna and are still early in the launch process, our revenue guidance excludes contribution from these tests.

    如 Marc 所分享,我們對近期推出之檢測在早期回饋感到滿意。鑑於我們尚未取得 Prosigna 的 Medicare 給付,且仍處於上市初期,我們的營收指引不包含這些檢測的貢獻。

  • Moving to profitability. We are maintaining our full year adjusted EBITDA guidance of greater than 26%, reflecting our expected investment to support our growth initiatives throughout the year. As always, while we plan expenses on an annual basis, adjusted EBITDA may fluctuate quarter to quarter.

    接著談獲利能力。我們維持全年調整後 EBITDA 指引高於 26%,反映我們預期將在全年投入資源以支持成長計畫。一如既往,雖然我們以年度為基礎規劃費用,但調整後 EBITDA 可能會在各季之間波動。

  • In closing, Q2 was a milestone quarter for Veracyte. We successfully launched two important new products that expand our ability to serve patients across the cancer care continuum while also delivering strong double-digit revenue growth, profitability, and cash generation.

    最後總結,第二季對 Veracyte 而言是具里程碑意義的一季。我們成功推出兩項重要新產品,擴大我們在癌症照護全流程中服務病患的能力,同時也交出強勁的兩位數營收成長、獲利能力與現金創造。

  • Combined with the strength of our core business, these achievements reinforce our confidence in our long-term growth opportunity and position us well to continue to deliver durable double-digit growth. We will now move into the Q&A portion of the call.

    結合核心業務的強勁表現,這些成果進一步強化我們對長期成長機會的信心,並使我們處於有利位置,得以持續交付穩健的兩位數成長。接下來我們將進入問答環節。

  • Operator, please open the lines.

    接線員,請開放線路。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • [Tycho Peterson, Jefferies].

    [Tycho Peterson,Jefferies]。

  • Unidentified Participant

    Unidentified Participant

  • This is Lauren on for Tycho. My first one would be on Decipher. With the lower guidance of about 1,000 tests, is this -- are you seeing a threat specifically from AI-based testing? And kind of off that topic, if these approaches kind of continue to improve, what do you see as the future workflow? Would it be an AI-first triage model followed by molecular confirmation? Or are there certain indications where molecular profiling will kind of remain the gold standard?

    我是代 Tycho 發言的 Lauren。我第一個問題是關於 Decipher。在指引下修約 1,000 例檢測的情況下,這是否代表你們特別看到來自 AI 型檢測的威脅?另外延伸這個話題,如果這些方法持續進步,你們認為未來的工作流程會是什麼樣子?會是以 AI 優先的分流(triage)模型,之後再以分子檢測確認嗎?或者在某些適應症上,分子分型仍會維持為黃金標準?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Lauren, thanks for the question. No, we're not actually. The reduction in our internal expectations for Decipher for the year is only in the low category where we took it down by about 1,000 tests, some of which -- most of which is actually behind us in the second quarter.

    Lauren,謝謝你的提問。不,實際上我們並沒有看到。我們對今年 Decipher 的內部預期下修僅限於低風險類別,我們將其下調約 1,000 例檢測,其中有一部分——其實大多數——已經反映在第二季。

  • And the real -- the rationale for that and what we're seeing there is the guideline change that happened at the end of last year where effectively for every test, whether molecular or AI-based for active surveillance, it was taken out of guidelines.

    而其真正原因、以及我們所看到的情況,是去年底發生的指引變更:實際上,針對主動監測(active surveillance)的每一項檢測,不論是分子檢測或 AI 型檢測,都被從指引中移除。

  • And so it's going to depend on -- for that to come back and grow in double digits. It's still growing in single digits for us, but for it to come back and grow in double digits, it's going to need the evidence that we talked about. So we had slightly higher expectations for that coming into the year than we currently do in low risk only.

    因此,這要回來並恢復兩位數成長,將取決於——我們目前仍是個位數成長,但若要回到兩位數成長,就需要我們先前談到的證據。所以我們在年初對低風險類別的預期略高於目前的看法。

  • And so that affects every test on the market in similar ways. Not everybody has the same comp. In fact, low was very good for us in this quarter last year. And I'm sure for others, they have different starting points. But from a share standpoint, we're not really seeing any difference at all.

    因此,這會以類似方式影響市面上的每一項檢測。並非每家公司都有相同的比較基期。事實上,去年同一季低風險對我們而言表現非常好。我也確信對其他公司而言,他們的起點不同。但就市占角度來看,我們並未看到任何差異。

  • And so I think to the second part of your question, I mean, it doesn't really feature when that's not the fact here. We still think that molecular and AI are complementary. They -- we already know they measure different parts of the biology and different things, and we've got a publication that we're working on that covers that that we've talked about previously. And so I think the two could potentially coexist at some point, but I don't think it's necessarily one or the other model. In fact, physicians consistently tell us more information is better than less.

    至於你問題的第二部分,我的意思是,既然目前並非這種情況,它其實不太是關鍵因素。我們仍然認為分子檢測與 AI 是互補的。我們已經知道它們衡量的是生物學的不同面向與不同內容;我們也正在準備一篇涵蓋此議題的論文,先前也提過。因此我認為兩者未來可能在某個時間點共存,但不一定是非此即彼的模式。事實上,醫師一再告訴我們:資訊越多越好。

  • Anything to add? No.

    還有要補充的嗎?沒有。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • I'll just add one quick thing, if you don't mind. And that really is to highlight the strength that we saw in the intermediate high-risk category as well as the durability of that strength given incremental data that we hope will be released here shortly, as Marc mentioned on the call.

    如果你不介意,我再快速補充一點。主要是想強調我們在中度至高風險類別所看到的強勁表現,以及在增量數據的支持下這種強勁表現的持續性;如 Marc 在電話會議中提到,我們希望這些數據很快就會發布。

  • And so yes, we have taken down the low category by a day or two across the portion of the year, but I think we are seeing great strength and performance as expected in intermediate and high. And those are the areas where we have the most evidence, we have the most guidelines and that will change here for low as well over the course of '27, '28, '29.

    所以是的,我們在今年的某一段期間把低風險類別下調了一兩天,但我認為我們在中度與高風險方面仍如預期看到非常強勁的力道與表現。而這些領域正是我們擁有最多證據、最多指引支持的地方;低風險方面也會在 2027、2028、2029 年期間逐步改變。

  • So I think it's just -- to me, the way I think about it is we have a great growth driver today and low is an incremental -- is an opportunity for incremental growth in the subsequent years and is a very untapped market at this point in time.

    因此我認為——對我而言,我的看法是:我們今天已經有很好的成長驅動因素;而低風險是一個在後續年度帶來額外成長的機會,且在目前時間點仍是一個尚未被充分開發的市場。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • And Lauren, maybe if I can start just to add to what Rebecca said. While we expect these low tablet studies to read out in '27, '28, we don't know if they're going to read out positively or not. But the good news is we have multiple shots on goal with multiple studies coming our way.

    Lauren,也許我先補充一下 Rebecca 所說的。雖然我們預期這些低風險研究會在 2027、2028 年讀出結果,但我們不知道結果是否會是正向。但好消息是,我們有多個「射門機會」:有多項研究即將陸續產出結果。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • That have been enrolling now for six, seven years. So exciting times.

    這些研究已經招募了六、七年。所以是令人振奮的時刻。

  • Unidentified Participant

    Unidentified Participant

  • That's super helpful. And then just one last one on kind of expansion of the market for Prosigna. I guess what percent of the existing Oncotype market do you think is like contestable over the next three to five years? And off of that, what do you expect the earliest uptake in, whether it's across the node-positive populations or just kind of color there.

    這非常有幫助。最後再問一個關於 Prosigna 市場擴張的問題。我想問的是,在未來三到五年內,你們認為現有 Oncotype 市場中大約有多少比例是可競逐的?另外,最早的採用會出現在哪裡——例如會是在淋巴結陽性族群,或是其他面向?想請你們提供一些說明。

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • This is John. Thanks for the question. Yes, we're not limiting ourselves to any specific subsegment of the breast market. We believe the entirety of the HER2-negative ER-positive population is addressable by our value proposition. The latest data from OPTIMA happens to add predictive claims to the node-positive population, both postmenopausal and premenopausal.

    我是 John。謝謝你的提問。是的,我們不會把自己限制在乳癌市場的任何特定子區隔。我們相信 HER2 陰性、ER 陽性族群的整體都可由我們的價值主張所涵蓋。OPTIMA 的最新數據也進一步為淋巴結陽性族群加入了預測性主張(predictive claims),涵蓋停經後與停經前族群。

  • But one of the large value proposition here we start with an accurate risk stratification to understand what is the real risk of progression in the 10-year time frame. And for that, we already have Level 1A evidence across the board. So like I said, we're excited by the OPTIMA results, but we're not limiting ourselves to just that node-positive population.

    但這裡其中一個重要的價值主張,是我們先從精準的風險分層開始,以了解在 10 年時間範圍內真正的進展風險是什麼。而就這一點而言,我們已經在各方面擁有 Level 1A 等級的證據。所以如我所說,我們對 OPTIMA 的結果感到振奮,但我們不會把自己侷限在僅僅是那個淋巴結陽性族群。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • And maybe one last thing to add. We haven't gone out and quantified what portion of the market we think we can take over the next three to five years. But I would say, as Marc cited in the script, based on some early feedback, we are very confident in our ability to have sustained growth with Prosigna and have had numerous conversations with centers that are large in nature who are contemplating not just dabbling and having more active procedures -- not procedures, I'm sorry, more active engagement to the point of effectively fully switching. So we are optimistic and our optimism is fueled by engagement with the market post the OPTIMA results.

    也許最後再補充一點。我們尚未對外量化我們認為未來三到五年能取得多少市場份額。但我想說,正如 Marc 在講稿中提到的,根據一些早期回饋,我們對 Prosigna 維持持續成長的能力非常有信心,而且我們已與許多規模很大的中心進行了多次對話;他們正在考慮的不只是小試身手、採取更積極的作法——不是「作業流程」,抱歉,是更積極的投入,甚至到實質上完全轉換的程度。因此我們是樂觀的,而我們的樂觀來自於 OPTIMA 結果公布後與市場的互動與參與。

  • Operator

    Operator

  • [Subbu Nambi, Guggenheim].

    [Subbu Nambi,Guggenheim]。

  • Unidentified Participant

    Unidentified Participant

  • This is Ricky on for Subbu. So for a little more color maybe on just how you're thinking about Prosigna going forward from more of a commercial lens. In our early KOL checks, oncologists have been really optimistic about adopting Prosigna and really excited about it, but EMR integration and ordering and results through the EMR were really the one headwind that's been mentioned in terms of increasing adoption. Could you speak to your plans for that type of integration or any other commercial or logistic initiatives you're focused on to support more Prosigna adoption?

    我是代 Subbu 提問的 Ricky。想再多了解一些,你們從更偏商業面的角度,未來如何看待 Prosigna 的發展。在我們早期的 KOL 訪談中,腫瘤科醫師對採用 Prosigna 非常樂觀、也很興奮,但在提升採用率方面,唯一被提到的阻力是 EMR 整合,以及透過 EMR 進行下單與回傳結果。你們能否談談對這類整合的規劃,或任何其他你們正聚焦、用以支持 Prosigna 更廣泛採用的商業或物流措施?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. Thanks for the question. We can't disagree. We believe that at volume, EHR integration goes a long way, not just to simplify the logistical burden on the practice administrators and the physicians, but also in just streamlining and even potentially automating some of the test ordering and automation into the overall workflow.

    可以。謝謝你的問題。我們不反對這個看法。我們相信在一定量體下,EHR 整合會帶來很大幫助,不僅能簡化診所行政人員與醫師在物流上的負擔,也能讓檢測下單流程更順暢,甚至可能把部分檢測下單自動化並納入整體工作流程。

  • Having said all that, we are heavily investing in our team here that's able to leverage both internal resources and external partners and external service providers to get us integrated with as many practices as possible. The good news here is that was already an activity that was on its way to support our Decipher and our Afirma business, and we can tag team on those efforts. But yes, absolutely can't anymore.

    話雖如此,我們正在大幅投資於這裡的團隊,使其能同時運用內部資源與外部合作夥伴、外部服務供應商,讓我們與盡可能多的診所完成整合。好消息是,這原本就是為了支持我們的 Decipher 與 Afirma 業務而在推進中的工作,我們可以在這些努力上協同作戰。但沒錯,絕對不能再拖了。

  • Operator

    Operator

  • Keith Hinton, Freedom Capital Markets.

    Keith Hinton,Freedom Capital Markets。

  • Keith Hinton - Analyst

    Keith Hinton - Analyst

  • Just one quick one on Decipher and then a question on guidance. On Decipher, can you just talk a little bit about the low-risk population, what kind of the penetration level is today for molecular diagnostics and with the guideline changes that you're hoping to have reversed in the future with additional data, kind of where you think that penetration rate could go over the next few years?

    先就 Decipher 快問一個,然後再問一個關於財測指引的問題。關於 Decipher,你能否談談低風險族群:目前分子診斷的滲透率大概是多少?以及隨著你們希望未來透過更多數據把指引變更「扭轉」回來,你們認為未來幾年那個滲透率可能提升到什麼程度?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes, happy to. I think about our penetration, we think we're about 20% penetrated into this important low-risk market. And in fact, the penetration is growing every quarter, even in this quarter, we saw a growth in the number of new customers and the growth in the number of ordering customers. And so it's continuing to grow at a rate that we said single digit that exceeds the rate of incidence growth. But for it to really kick into a new gear, it will -- we do think it will need that NCCN guideline.

    可以,很樂意。就我們的滲透率而言,我們認為在這個重要的低風險市場中,目前大約滲透了 20%。而且事實上,滲透率每一季都在成長;即便在本季,我們也看到新客戶數增加,以及下單客戶數增加。因此它持續以我們所說的個位數成長率在成長,且高於發生率(incidence)的成長速度。但若要真正進入新的成長檔位——我們確實認為需要 NCCN 指引。

  • So between now and then, I think it's going to continue to penetrate more as it grows every quarter -- hopefully, every quarter and certainly every year. And then I think guidelines put it in the same category as intermediate and now what we're seeing with high risk.

    所以在那之前,我認為它會持續提高滲透率,因為每一季都在成長——希望每一季如此,當然每一年也是。然後我認為指引會把它放到與中風險、以及我們現在在高風險所看到的相同類別。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • And that is, to be clear, our expectation is that we believe that we can have at least 80% penetration and a similar amount of share, if not more, on a sustainable basis on optimized penetration. So there's a huge runway not only in the low-risk opportunity, but equally in the high and to a lesser extent, intermediate, though there's still immense amount of white space left in intermediate.

    而且要說清楚,我們的預期是:在滲透率最佳化後,我們相信至少可以達到 80% 的滲透率,並在可持續的基礎上取得相近、甚至更高的市占。因此不僅低風險機會有很長的跑道,高風險同樣如此;至於中風險雖然相對少一些,但仍然有大量未開發空間。

  • You want to move on to the Decipher question, Keith? I'm sorry, the guidance question?

    Keith,你要接著問 Decipher 的問題嗎?抱歉,是財測指引的問題?

  • Operator

    Operator

  • Jacob Dodd, Morgan Stanley.

    Jacob Dodd,Morgan Stanley。

  • Jacob Dodd - Analyst

    Jacob Dodd - Analyst

  • Quickly, if I'm wrong, I believe Prosigna launched with commercial coverage, but not with MolDx. Could you help us understand how you're managing patient access for Medicare beneficiaries right now? Are you performing those tests at risk? And then what is your current expectation for the MolDX time line and confidence level based on OPTIMA data?

    很快問一下:如果我沒記錯,Prosigna 上市時有商業保險給付,但沒有 MolDx。你能否幫我們理解,你們目前如何管理 Medicare 受益人的病患可近性?你們是在承擔風險的情況下先做這些檢測嗎?另外,基於 OPTIMA 數據,你們目前對 MolDX 時程的預期與信心程度如何?

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • Yes. So Prosigna has already enjoyed coverage from Medicare via our on-market FDA-approved product. Our plan had been to transition away from the FDA distributed product towards a centralized [LDT] so from a coverage perspective, we're covered. The process moving forward is to submit a tech assessment that outlines our lab validation, the analytical validation, our bridging study through the FDA-approved product and platform and to have that reviewed and subsequently approved by Medicare.

    是的。因此,Prosigna 透過我們已在市場上的 FDA 核准產品,已經獲得 Medicare 的給付。我們的計畫是從 FDA 分銷的產品轉向集中式的 [LDT];因此就給付角度而言,我們是有涵蓋的。接下來的流程是提交一份技術評估(tech assessment),說明我們的實驗室驗證、分析驗證,以及透過 FDA 核准產品與平台所做的橋接研究,並讓 Medicare 審查並在後續核准。

  • We've already been enjoying a few exchanges with MolDX. We see the path forward as fairly straightforward and kind of see the approval of that tech assessment imminently. The last step would then be an agreement of pricing. And for that, we have multiple paths to secure price. And we've guided before to expect the low end of that pricing around $2,500.

    我們已經與 MolDX 進行了幾次交流。我們認為接下來的路徑相當直接,也預期該技術評估會在近期獲得核准。最後一步則是就定價達成一致。而在定價方面,我們有多條路徑可以取得價格。我們先前也已指引,預期該定價區間的低端大約在 2,500 美元左右。

  • Operator

    Operator

  • Keith Hinton, Freedom Capital Markets.

    Keith Hinton,Freedom Capital Markets。

  • Keith Hinton - Analyst

    Keith Hinton - Analyst

  • Just quickly on guidance. Obviously, the results in the first two quarters of the year have been meaningfully above that 26% floor that you guys have given, which you maintained. So I just want to ask sort of how much of that is the incremental investment you talked about kind of pulling forward some of the sales force build for Prosigna and how much of it is just conservatism or however you kind of want to think about it? And if you want to just -- if you can give any color to the level of investment that you're pulling forward for Prosigna as well?

    快速問一下關於財測指引。顯然,今年前兩季的結果都明顯高於你們給出的 26% 底線,而你們仍維持該指引。所以我想問,這當中有多少是你們提到的增量投資——例如為 Prosigna 提前推進部分銷售團隊的擴編——又有多少只是保守起見,或你們想怎麼看待都可以?另外,你們是否能就為 Prosigna 提前拉動的投資規模提供一些補充說明?

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • Yes. So I'll handle that last part first. So we are going from a roughly 10-person sales force exiting this year to a 15-person sales force as this year. So that's not going to be a material and that meaningful of a contribution.

    好的。我先回答最後那一部分。我們將把銷售團隊從今年結束時大約 10 人,擴增到今年內達到 15 人。因此那不會是重大的、也不會是非常顯著的貢獻。

  • As John spoke about, obviously, EMRs are part of our activity plan here, and that is something that we are investing in and we'll invest as much as we can because that is such a high ROI endeavor. That being -- all that being said, I wouldn't call this conservatism, Keith.

    如 John 所提到的,很明顯地,EMR 是我們這裡活動計畫的一部分,這也是我們正在投資、而且會盡可能加大投資的項目,因為這是一項投資報酬率(ROI)非常高的工作。話雖如此,Keith,我不會把這稱為保守。

  • I would call it two things. One, we have a huge opportunity in front of us with a deep, deep pipeline across multiple indications, across multiple portions of the care continuum that we want to invest in to drive higher revenue growth in the future, even above and beyond the relatively attractive levels we are today. So I think we have a great opportunity in front of us across MRD, Decipher, Afirma, the rest of the urology space, and obviously, Prosigna. And so we're investing heavily in there.

    我會把它歸結為兩件事。第一,我們面前有一個巨大的機會:在多個適應症、照護連續體的多個環節上,我們都有非常、非常深的產品管線,我們希望投入資源,以在未來推動更高的營收成長,甚至超越我們目前相對具吸引力的水準。所以我認為,我們在 MRD、Decipher、Afirma、泌尿科領域的其他部分,以及當然還有 Prosigna 上,都有很好的機會。因此我們正在大力投資。

  • I would say the other thing on our guide is we don't necessarily guide on a go-forward basis with PPCs and PPCs have been a significant contributor to the outperformance year-to-date. And so that is just something to take into account. We don't guide that in revenue, and we don't guide it in profitability.

    我想我們指引的另一點是:我們不一定會在前瞻基礎上把 PPC 納入指引,而 PPC 今年迄今一直是超預期表現的重要貢獻來源。所以這是需要納入考量的一點。我們不會在營收指引中納入它,也不會在獲利指引中納入它。

  • And then I would -- the last thing I would say on gross margin, we've had amazing gross margin performance as we do see significant Prosigna volume in the back half of the year, given our revenue recognition policies, as well as just the lack of reimbursement from the get-go that is going to be a slight headwind, and that would be something to take into account if you want to call that Prosigna investment, feel free, but those are really the contributing factors.

    最後我想談一下毛利率:我們的毛利率表現非常出色;但由於依照我們的營收認列政策,下半年會看到相當可觀的 Prosigna 量,再加上一開始就缺乏給付(reimbursement),這會帶來些微逆風;如果你想把這稱為 Prosigna 投資也可以,但這些才是真正的主要影響因素。

  • Operator

    Operator

  • Puneet Souda, Leerink Partners.

    Puneet Souda,Leerink Partners。

  • Puneet Souda - Analyst

    Puneet Souda - Analyst

  • So just on Decipher, just wondering, Decipher low risk, do you believe there was any impact from the ACA disenrollment on the volumes -- or was this all largely comp issues that you saw in the quarter? And how should we think about overall growth for Decipher? You pointed out a number of drivers that helped in 2024, NCCN and it's been a very strong product. But how should we think about sort of the stable growth trajectory? What is that number for Decipher?

    關於 Decipher,我想問一下:Decipher 低風險這一塊,你們認為 ACA 退保(disenrollment)對檢測量是否有任何影響——還是說這一季你們看到的主要是比較基期(comp)問題?另外我們應該如何看待 Decipher 的整體成長?你提到 2024 年有多個驅動因素,包括 NCCN,而且這一直是個非常強的產品。但我們應該如何看待相對穩定的成長軌跡?Decipher 的那個數字是多少?

  • And I'm wondering if you can provide anything for 2027 color, if you would like to.

    另外,如果你願意的話,我也想看看你能否提供一些 2027 年的補充說明(color)。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. Thanks, Puneet. It's a combination of, I think, the comp and what we're seeing in the low risk, which is, as I mentioned, it's kind of more of a single-digit grower, not a double-digit grower right now based on what we're seeing. And so still growing, but not at the same level as the rest of the Decipher risk categories, obviously, given those guidelines for NCCN. And so we expect that to continue, and that's why we adjusted our outlook by about 1,000 tests.

    可以。謝謝你,Puneet。我認為這是比較基期以及我們在低風險端看到的情況的綜合結果;如我提到的,依我們目前所見,低風險現在比較像是個個位數成長的項目,而不是雙位數成長。所以仍在成長,但顯然不如 Decipher 其他風險類別的成長幅度,這也與 NCCN 的那些指引有關。因此我們預期這種情況會持續,這也是為什麼我們把展望調整了大約 1,000 份檢測。

  • We also have very strong performance on the revenue line for Decipher as well. And so we've maintained Decipher around 20% revenue growth for the year, which is very healthy. We are extremely excited about high risk and intermediate that are both growing very, very nicely given our competitive advantages in NCCN guidelines there and the raft of evidence that we have supporting Decipher's use of clinical decisions in those two contexts. And when I say high risk, of course, that includes PCR and metastatic, which is a relatively new area for us as well. So when you put all together, those parts are growing nicely.

    我們在 Decipher 的營收表現也非常強勁。因此我們維持 Decipher 全年約 20% 的營收成長,這是非常健康的水準。我們對高風險與中間風險兩個區塊都非常興奮,因為在 NCCN 指引上的競爭優勢,以及我們擁有的大量證據支持 Decipher 在這兩種情境下用於臨床決策,使得它們都成長得非常、非常好。而我所說的高風險,當然也包含 PCR 與轉移性(metastatic),這對我們而言也是相對較新的領域。所以綜合來看,這些部分都在良好成長。

  • Decipher, to your question on kind of the go-forward trajectory, Decipher is on this very straight line. I think I mentioned it before. The -- when you look at it, it's got a very high R squared and what's happening there, it's highly predictable in that regard. And I don't see any reason why that kind of trend line should change in the next couple of years. It seems to be around 20,000 tests a year, plus or minus 1,000 or so and that's the variability that I would put on that. And like I said, I don't see much coming that would change that other than in that time frame we talked about, hopefully, we get the evidence to get low risk to be in a very similar category.

    至於你問到 Decipher 未來的成長軌跡,Decipher 基本上呈現一條非常筆直的趨勢線。我想我之前提過。當你看這條線時,它的 R 平方值非常高;也就是說,從這個角度來看,它的表現高度可預測。而我看不出未來幾年這種趨勢線有什麼理由會改變。看起來大約是每年 20,000 份檢測,上下加減約 1,000 左右;我會把變動範圍界定在這個程度。如我所說,我不認為會有太多因素改變這點,除非在我們談到的那段時間內,我們希望能取得足夠證據,讓低風險也能進入非常類似的類別。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • And maybe just one thing while I have the opportunity to add on the Afirma number for next year, I just would like everyone to remember that we have the benefit of the NRR in our '26 results and our '26 guide that will create a harder comp next year on Afirma.

    另外趁這個機會補充一下明年 Afirma 的數字:我想提醒大家,我們在 2026 年的結果與 2026 年指引中,會受惠於 NRR,這會讓明年 Afirma 的比較基期變得更具挑戰。

  • And then also Afirma PTCs have been quite outstanding year-to-date. So just please take those two things into account when you're looking at your '27 numbers for Afirma.

    此外,Afirma 的 PTC 今年迄今表現相當亮眼。所以在你們看 Afirma 的 2027 年數字時,請把這兩點一併納入考量。

  • Puneet Souda - Analyst

    Puneet Souda - Analyst

  • Got it. That's helpful. And then when we think about Prosigna, there is a premenopausal node positive position that could benefit patients that could benefit. Could you elaborate sort of what the discussions have been so far? How is the traction in the market just since the launch? How should we think about any volume numbers this year or next year for Prosigna?

    了解。這很有幫助。接著談 Prosigna:有一個「停經前、淋巴結陽性」的定位,可能會讓病人受益、也可能帶來受益。你能否說明一下目前為止相關討論的進展?自從上市以來,市場的牽引力(traction)如何?我們應該如何看待 Prosigna 今年或明年的任何量的數字?

  • John Leite - Global Chief Commercial Officer

    John Leite - Global Chief Commercial Officer

  • Well, from a market response, I'd say the market responded very, very favorably to the release of the OPTIMA trial data. Obviously, premenopausal and high node burden in general is what caused probably the larger splash effect because it is so game-changing. Nevertheless, as I've been saying, we believe that our overall opportunity covers the gamut of the HER2-negative ER-positive population.

    就市場反應而言,我會說市場對 OPTIMA 試驗數據的發布反應非常、非常正面。很明顯地,停經前以及整體而言較高的淋巴結負荷,可能是造成更大「轟動效應」的原因,因為這確實具有顛覆性。不過,如我一直所說,我們相信我們的整體機會涵蓋 HER2 陰性、ER 陽性族群的各個面向。

  • But nevertheless, that's why I imagine, those physicians are going to start and then expand from there if it ends up in a land and expand strategy with some physicians and quite a few of them, I believe that will be the case. Others we've had discussions with are ready to pull the trigger wholesale because it's just easier to deal with one provider. And so the conversation turns very quickly from clinical to logistical.

    但也正因如此,我想這些醫師會先從那裡開始,之後再擴展;如果最後形成某些醫師採取「先落地再擴張(land and expand)」的策略,而且我相信不少人會如此。我們也和其他一些醫師討論過,他們已準備好全面採用,因為只跟一家供應商合作在作業上更容易。因此對話很快就會從臨床面轉向物流與作業面。

  • With regards to numbers, we're not quite there to guide with target. We're going to allow ourselves the opportunity to collect data over the next coming months before we can guide with some accuracy.

    至於數字方面,我們目前還不到可以提供目標指引的階段。我們會先讓自己在接下來幾個月有機會蒐集數據,之後才能更精準地給出指引。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • And Puneet, just to remind everybody, I mean, there are hundreds -- I mentioned that there are hundreds of publications to support Prosigna's use in no negative population as well. So to John's point, I mean, I think it's both the ease and also the level of evidence and the robustness behind Prosigna and the PAM50 signature that is also appealing.

    Puneet,我也提醒大家一下:我提過有數百篇文獻支持 Prosigna 也可用於淋巴結陰性族群。所以呼應 John 的觀點,我認為吸引人的不只是便利性,還有 Prosigna 以及 PAM50 特徵(signature)背後的證據等級與扎實程度。

  • Puneet Souda - Analyst

    Puneet Souda - Analyst

  • Got it. Okay. And just last clarification. I might have missed this, but the Decipher growth was more than 20% that is now going to be at 20% held constant. Just wanted to clarify on that point for this year guide.

    了解。好的。最後再澄清一下。我可能漏聽了,但 Decipher 的成長率原本超過 20%,現在會以 20% 持平不變。只是想就今年的指引把這點確認清楚。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. To be clear, that's the revenue -- the revenue guide is at 20%. And we gave very specific numbers for Q3 and Q4 for volume. Now of course, don't forget, there's always this quarterly volume variability that can come from the timing of receiving orders and tissue coming in the door and results being reported out. So you should always expect that level of a day's worth of variability, give or take.

    是的。講清楚一點,那是營收——營收指引是 20%。而且我們也針對 Q3 和 Q4 的量給了非常具體的數字。當然別忘了,季度檢測量一向會有波動,可能來自接單時間點、檢體進到實驗室的時間,以及結果出具的時間點。所以你應該一向預期會有以「一天左右」為單位的波動,上下浮動皆有可能。

  • I mean, remember, given how much we've grown now in Decipher, the days volume is 500 tests or so. And so it's very significant running through our lab every single day. And so you should expect the normal level of fluctuation on the quarterly numbers. We always stay focused on the year. But overall, we're guiding roughly 20% growth for Decipher revenue growth for the year.

    我的意思是,記得以我們現在 Decipher 的成長規模來看,每日檢測量大約是 500 份左右。所以每天在我們實驗室跑的量非常可觀。因此你應該預期季度數字會有正常程度的起伏。我們一向把重點放在全年。但整體而言,我們對今年 Decipher 營收成長的指引大約是 20%。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • And Puneet, the ASP gains that we've gotten are making up for the 1,000 test delta in the volume guide but there are prior periods in the back half of last year as the comp to take into account on pricing. Just we can go through that later today, if you want.

    另外,Puneet,我們拿到的 ASP(平均售價)提升,正在彌補量的指引中 1,000 份檢測的差額,但在定價比較基期上,也要把去年下半年先前期間納入考量。如果你願意,我們今天晚些時候可以再把這部分細節走一遍。

  • Operator

    Operator

  • Mason Carrico, Stephens.

    Mason Carrico,Stephens。

  • Mason Carrico - Equity Analyst

    Mason Carrico - Equity Analyst

  • Jumping between a few tonight, so sorry if this has been asked, but I'll just keep it to one here. Could you update us on the TrueMRD pipeline? When should we expect to see the next data readout? And when will we learn more about the next submission to MolDx or indication that you'll be targeting there?

    我今晚在幾場電話會議之間來回切換,所以如果這題已經有人問過先說聲抱歉,但我這邊就只問一題。能否更新一下 TrueMRD 的產品/研發管線進度?我們應該何時會看到下一次數據讀出?以及我們何時會更清楚你們下一次向 MolDx 提交的時間點,或你們會鎖定的適應症方向?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. Thanks, Mason. No, that hasn't been asked. Focusing on TrueMRD, obviously, we're very happy with the launch of our first test in muscle invasive bladder cancer. We've always talked about that's kind of our landmark test, if you like, that helps us pilot our MRD approach in a relatively small but very important indication.

    好的。謝謝你,Mason。沒有,這題還沒被問到。聚焦 TrueMRD 的話,顯然我們對於在肌肉浸潤性膀胱癌推出第一個檢測的上市表現非常滿意。我們一直都說,這算是我們的里程碑檢測(如果你願意這麼稱呼),能幫助我們在一個相對較小、但非常重要的適應症中,先行驗證並試行我們的 MRD 方法。

  • That's where we're focused right now. Meantime, we do have our development teams and our clinical teams working on the next levels of evidence development and the next assays and so on. So we'll talk more about that when we're ready to launch those tests. We had a review just this week on the various studies that are going on and when they're expected to read out in different indications. And it's good.

    這就是我們目前的重點。同時,我們的研發團隊與臨床團隊也在推進下一階段的證據建立、下一代檢測(assays)等工作。等到我們準備好推出那些檢測時,我們會再分享更多。我們就在本週針對各項正在進行的研究做了檢視,包含它們在不同適應症中預計何時讀出數據。整體進展不錯。

  • There's a lot. There's a lot of things happening. And hopefully, we'll add to that over the next few years as well. So excited for the bladder test to prove the proof point here and then expand on that.

    事情很多。有很多事情正在發生。也希望未來幾年我們能在此基礎上再持續增加。所以很期待膀胱癌檢測能在這裡先證明概念,然後再往外擴展。

  • Operator

    Operator

  • Kyle Mikson, Canaccord Genuity.

    Kyle Mikson,Canaccord Genuity。

  • Unidentified Participant

    Unidentified Participant

  • This is Alex on for Kyle Mikson. Apologies if there's a repeat on a few different calls today. But so Prosigna NGS become available for order June 8 and it's covered by a number of commercial payers in the past. Can you just comment on early test adoption? Do you believe that the OPTIMA study results could be the key guideline inclusion or either future or true test volume inflection?

    我是代 Kyle Mikson 發言的 Alex。如果今天在不同電話會議中有些問題重複,先致歉。Prosigna NGS 在 6 月 8 日開始可供下單,而且過去也已被多家商業保險給付。你們能否談談早期的檢測採用情況?你們是否認為 OPTIMA 研究結果可能是納入臨床指引的關鍵,或是未來/真正帶動檢測量出現拐點的關鍵?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. So I'll take that one at a time. So with regards to adoption, yes, we're very pleased with both the reaction that we've gotten from physicians, I would say, even unexpectedly from patients who've reached out to us directly asking how they can get the test. And having seen now the first few results going back, it's just been very emotional and very gratifying to be able to start to help this important pool of patients. But I think it absolutely signifies that we will see healthy adoption.

    好的。我分開回答。就採用情況而言,是的,我們對醫師端的反應非常滿意;我想甚至有些出乎意料的是,也有病患直接聯繫我們,詢問他們要如何取得這項檢測。而且現在看到前幾批回傳的結果,能開始幫助這個重要的病患族群,情緒上很激動,也非常有成就感。但我認為這絕對顯示我們會看到健康的採用速度。

  • We're very happy with the early KPIs, like I said, with the response as well. There's always a bit of a lag in terms of setting up accounts and our logistical systems and ensuring that we are clear to their procurement offices, but we're happy with where we're tracking this soon after the launch.

    如我所說,我們對早期 KPI 也很滿意,包含市場回應。當然,在建立客戶帳戶、完善物流系統,以及確保我們在對方採購部門的流程上都清楚到位方面,通常會有一些時間落差,但就上市後這麼短的時間來看,我們對目前的進度很滿意。

  • As it relates to the OPTIMA trial, yes, we believe that it is generally acknowledged as Level 1A evidence and as such, should make its way to guidelines. What stands in our way between now and then is a publication. As we've communicated in the past, that's out of our hands. This is an independent study run by a group of PIs, and we'll keep you posted as we make progress and as the guidelines review the data.

    至於 OPTIMA 試驗,是的,我們相信它普遍被認可為 1A 級證據,因此理應會被納入臨床指引。目前從現在到那一步之間的主要障礙是論文發表。如同我們過去所溝通的,這不在我們掌控之中。這是一項由一群主要研究者(PI)主導的獨立研究;我們會在進展推進、以及指引單位審查數據時,持續向各位更新。

  • Operator

    Operator

  • David Westenberg, Piper Sandler.

    David Westenberg,Piper Sandler。

  • Unidentified Participant

    Unidentified Participant

  • This is Baron on for David Westenberg. I've been jumping around as well, so I'll keep it brief and apologies if this has been asked. But maybe sticking with the pipeline, can you give us an update on the NIGHTINGALE study? I think previously, you mentioned roughly 90% enrolled. I guess can you -- when could we expect to hear maybe intermediate data?

    我是代 David Westenberg 發言的 Baron。我也在幾場會議間切換,所以我會簡短提問;如果這題已經有人問過也先致歉。延續管線的話題,你們能否更新一下 NIGHTINGALE 研究?我記得你們之前提到大約完成 90% 收案。想請問——我們大概何時能聽到一些中期數據?

  • Yes, that would be appreciated.

    是的,如果能分享會很感謝。

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes, happy to. And no, it hasn't been asked. The NIGHTINGALE study, just to remind everybody, is our -- it's a very extensive study that we have done on Percepta Nasal Swab test. And it was completed in enrollment last August, I believe it was. So we're about a year in now, almost a year into having those first patient follow-ups. And it's going to be a while before that fully reads out. So we're treating that as one of our longer-term growth drivers. And so that's where we are on Nightingale. Looking forward to seeing how that reads out once we've got all the patients followed for at least one year, if not potentially two.

    好的,很樂意。而且沒有,這題也還沒被問到。NIGHTINGALE 研究,提醒大家一下,是我們針對 Percepta 鼻拭子(Nasal Swab)檢測所做的一項——規模非常龐大的研究。我記得它是在去年 8 月完成收案。所以現在大約過了一年,幾乎是一年,從第一批病患開始追蹤回訪算起。而距離完全讀出結果還需要一段時間。因此我們把它視為較長期的成長驅動因素之一。這就是 Nightingale 目前的進度。等到所有病患至少完成一年的追蹤(甚至可能兩年)後,我們也很期待看到最終讀出結果。

  • Operator

    Operator

  • Joseph Conway, Needham & Company.

    Joseph Conway,Needham & Company。

  • Joseph Conway - Analyst

    Joseph Conway - Analyst

  • Maybe one on Decipher to start out with. Really strong quarter. Just wondering maybe how much of the growth in the quarter, if you could dissect it, is maybe from expansion into new use cases or newer use cases, whether it be like treatment intensification or the metastatic setting versus maybe just higher overall penetration in the use cases that you guys have had for the last handful of years?

    也許先從 Decipher 談起。本季表現非常強勁。想請教如果可以拆解一下,本季成長有多少可能來自於拓展到新的或較新的使用情境(例如治療強化或轉移性情境),相較於你們過去幾年既有使用情境中的整體滲透率提升?

  • And then maybe just in the same vein, looking forward, what -- which of those buckets do you think will be more repeatable over the next couple of years, whether it be new indications or continued market penetration in existing?

    另外同樣延伸這個問題,往前看,未來幾年你認為哪一類成長會更具可重複性——是新適應症,還是既有市場中的持續滲透?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. I think the best way to actually think about it is the risk categories that we've been discussing Decipher. And within each of those risk categories, more evidence comes out that adds either more prognostic or predictive claims.

    是的。我認為最好的思考方式其實是我們一直在討論的 Decipher 風險分層。而在每一個風險類別中,都會有更多證據出來,增加更多的預後(prognostic)或預測(predictive)主張。

  • And a good example of that is in high-risk and metastatic, where you've seen evidence come out in -- at ESMO for Stampede and then at ASCO for ENZAMET, which keep adding these predictive claims and it's one of the factors that is helping to grow the high-risk and metastatic category, which is one of the higher growth driver categories within Decipher.

    一個很好的例子是在高風險與轉移性族群,你已經看到證據在——例如 ESMO 的 STAMPEDE,以及 ASCO 的 ENZAMET——陸續發表,持續增加這些預測性主張;這也是推動高風險與轉移性類別成長的因素之一,而該類別也是 Decipher 之中成長驅動力較高的類別之一。

  • And intermediate continues to be an absolute store of growth in terms of adding new -- we're constantly adding new customers who have not ordered Decipher before. We're seeing a nice uptick in the ordering rate per customer, which means they're expanding it across their patient population, even within an intermediate risk category, for example. And so other than low risk, which again, just to remind people, low risk is growing in terms of we're adding new customers for low risk, but it's not growing at the double-digit rate. It's more of the single-digit rate now.

    而中度風險(intermediate)在成長方面仍然是非常重要的來源,因為我們持續新增——我們不斷新增以前從未下單過 Decipher 的新客戶。我們也看到每位客戶的下單率有不錯的提升,這代表他們正在把使用範圍擴大到其病患族群之中,即使是在例如中度風險類別內也是如此。因此,除了低風險之外——再次提醒大家,低風險仍在成長,因為我們也在為低風險新增客戶,但它不再以兩位數的速度成長。目前更偏向個位數成長。

  • So I think if you think about it like that, it's -- the growth in the next couple of years is going to come from high risk and intermediate and then the growth after that is going to come from low risk when we have the active surveillance evidence supporting that guidance.

    所以我認為如果用這樣的方式來看,未來幾年的成長將來自高風險與中度風險;再往後的成長則會來自低風險,當我們有主動監測(active surveillance)的證據支持相關指引時。

  • Rebecca Chambers - Chief Financial Officer

    Rebecca Chambers - Chief Financial Officer

  • And the other thing outside of the prostate portion of the urology market for Decipher, obviously, we're quite excited about the opportunity for bladder. It's just starting to get going, but the data evidence generation engine has been fully at work here now for a couple of years. And so we are incrementally excited about the bladder opportunity in the back half of the decade as well.

    另外,除了 Decipher 在泌尿科市場中前列腺這一塊之外,顯然我們也對膀胱癌的機會感到相當興奮。目前才剛開始起步,但數據與證據產生的引擎在這裡已經全力運作了好幾年。因此,我們也逐步對本十年後半段的膀胱癌機會感到更加期待。

  • Joseph Conway - Analyst

    Joseph Conway - Analyst

  • Okay. Great. And then just one more. I know you guys get this question a decent amount. But just in terms of share buybacks or M&A, obviously, there's a -- you have a couple of launches and pipeline projects that are prioritizing a lot of investment now.

    好的。很棒。再問最後一個。我知道你們常被問到這個問題。但就庫藏股回購或併購(M&A)而言,顯然你們目前有幾個產品上市與研發管線專案,正優先投入大量資金。

  • But is there maybe a specific like cash balance or profitability metric where you guys start thinking about buybacks more or maybe it's more about waiting until the launches and the pipeline is more in the rearview? I'm just wondering how you guys are thinking about that, if it's more of a dollar metric or more of a milestone kind of thing.

    不過,是否有某個特定的現金餘額或獲利能力指標,會讓你們開始更認真考慮回購?或者更像是等到產品上市與管線進展都比較告一段落之後?我想了解你們怎麼思考這件事:是以金額指標為主,還是以里程碑為主?

  • Marc Stapley - Chief Executive Officer, Director

    Marc Stapley - Chief Executive Officer, Director

  • Yes. No, not really. I wouldn't say it was that scientific. It's really -- we look at the capital deployment in really three categories. One is continued investment in our business, and Rebecca ran through earlier some of the things that we're doing there to really help drive the launch of these two new products.

    是的。不,並沒有。我不會說這件事有那麼科學化。基本上——我們把資本配置主要看成三大類。第一類是持續投資我們的業務,而 Rebecca 先前也提到我們在這方面做的一些事情,主要是為了真正推動這兩項新產品的上市。

  • Our pipeline of additional new products and innovations and also the core growth in Decipher and Afirma. So that's priority number one is invest in the business and continue to make it grow as we have done year after year after year.

    以及我們後續更多新產品與創新的研發管線,還有 Decipher 與 Afirma 的核心成長。所以第一優先就是投資業務,並持續推動成長,就像我們一年又一年所做的那樣。

  • The second is, you've mentioned it, the M&A, we've done a few acquisitions as a company, and we do look at the market, and we look at a lot of different things, and we're very open to the right assets being a part of Veracyte at the right time.

    第二類是你提到的併購(M&A)。我們公司做過幾次收購,我們也會觀察市場、評估很多不同的事情;只要在合適的時間出現合適的資產,我們非常願意讓它成為 Veracyte 的一部分。

  • And then the third category would be returning to investors in the way that you've described. And that to me, at this point, when you think of all these other two categories and the things we got ahead of us and the opportunities for us to deploy capital is not top of mind, but we regularly look at that and discuss it. So you can rest assured it's certainly on the docket. It's just we've got plenty of things going on right now.

    第三類則是以你所描述的方式回饋投資人。就我目前來看,考量前面兩類以及我們接下來要做的事情、以及我們可運用資本的機會,這並不是最優先想到的事項,但我們會定期檢視並討論。所以你可以放心,這確實在議程上。只是我們現在手上正在進行的事情很多。

  • Operator

    Operator

  • Thank you. This concludes the question-and-answer session and today's conference call. Thank you for participating. You may now disconnect.

    謝謝。問答環節與今天的電話會議到此結束。感謝各位參與。您現在可以掛線。