CareDx Inc (CDNA) 2025 Q3 法說會逐字稿

Hello, and thank you for standing by. My name is Regina, and I will be your conference operator today. At this time, I'd like to welcome everyone to the CareDx third quarter 2025 financial results conference call. (Operator Instructions) I'd now like to turn the conference over to Tina Jacobsen, Vice President of Investor Relations. Please go ahead.

您好，感謝您的耐心等待。我叫雷吉娜，今天我將擔任你們的會議接線生。在此，我謹代表 CareDx 公司歡迎各位參加 2025 年第三季財務業績電話會議。（操作員指示）現在我將會議交給投資者關係副總裁蒂娜·雅各布森。請繼續。

Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the third quarter 2025 ending September 30, 2025. The result is currently available on the company's website at www.caredx.com.

謝謝接線生。午安.感謝您今天蒞臨。今天早些時候，CareDx 發布了截至 2025 年 9 月 30 日的 2025 年第三季財務業績。目前結果已公佈在公司網站 www.caredx.com 上。

Joining me on today's call are John Hanna, President and Chief Executive Officer; and Nathan Smith, Chief Financial Officer.

今天與我一起參加電話會議的有總裁兼執行長約翰漢納，以及財務長內森史密斯。

Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions.

在正式開始之前，我想提醒大家，管理階層將在本次電話會議中發表一些前瞻性聲明。本次電話會議中任何非歷史事實的陳述均應視為前瞻性陳述。所有前瞻性陳述均基於目前的估計和各種假設。

These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

這些聲明涉及重大風險和不確定性，可能導致實際結果與這些前瞻性聲明中預期或暗示的結果有重大差異。因此，您不應過度依賴這些說法。

Information concerning the risks, uncertainties and other factors that could cause results to differ from these forward-looking statements are included in our filings with the Securities and Exchange Commission.

有關可能導致實際結果與這些前瞻性陳述存在差異的風險、不確定性和其他因素的信息，已包含在我們向美國證券交易委員會提交的文件中。

The information provided in this conference call speaks only to the live broadcast today, November 4, 2025. We disclaim any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward-looking statements, whether because of new information, future events or otherwise.

本次電話會議提供的資訊僅與今天（2025年11月4日）的直播有關。除法律要求外，我們不承擔任何更新或修改任何資訊、財務預測或其他前瞻性陳述的意圖或義務，無論是因為新資訊、未來事件或其他原因。

This call will also include a discussion of certain non-GAAP financial measures. These non-GAAP financial measures should be considered in addition to, not as a substitute or in isolation from GAAP measures. Reconciliations of our non-GAAP financial measures to the most directly comparable GAAP financial measures may be found in today's earnings release, which is posted to our website.

本次電話會議也將討論一些非GAAP財務指標。這些非GAAP財務指標應作為GAAP指標的補充考慮，而不是替代或孤立地考慮GAAP指標。有關我們非GAAP財務指標與最直接可比較的GAAP財務指標的調節表，請參閱今天發佈在我們網站上的盈利報告。

I will now turn the call over to John.

現在我將把通話轉給約翰。

Thank you, Tina, and welcome to everyone joining today's call. We had a strong third quarter on many fronts, including record volume and record revenue in testing services, patient and digital solutions and our lab products businesses. Our strategy of solution selling is working.

謝謝蒂娜，也歡迎各位參加今天的電話會議。第三季我們在許多方面都取得了強勁的成績，包括檢測服務、患者和數位解決方案以及實驗室產品業務的銷售和收入均創歷史新高。我們的解決方案銷售策略正在發揮作用。

At CareDx, our mission is clear: to create life-changing solutions that enable transplant patients to thrive. We are uniquely positioned as the only company serving transplant patients from end to end, delivering innovative diagnostics, digital tools and patient support that span the entire transplant journey.

CareDx 的使命很明確：創造改變人生的解決方案，使移植患者能夠茁壯成長。我們是唯一一家為移植患者提供從頭到尾服務的公司，提供涵蓋整個移植過程的創新診斷、數位工具和患者支持，這使我們擁有獨特的優勢。

Our strategy is rooted in putting patients and their care teams at the centre of everything we do, and you'll see this reflected in our product innovations, operational excellence and the way we partner with transplant centres worldwide. At the core of this strategy lies an exceptional team.

我們的策略以患者及其護理團隊為中心，您將在我們的產品創新、卓越營運以及我們與全球移植中心的合作方式中看到這一點。這項策略的核心在於一支卓越的團隊。

The true driving force behind our success. To further strengthen the outstanding group here at CareDx and advance our mission, I was delighted to announce in October the appointment of Suresh Gunasekaran, President and CEO of UCSF Health to our Board of Directors.

我們成功的真正驅動力。為了進一步加強 CareDx 的優秀團隊並推進我們的使命，我很高興地宣布，10 月任命加州大學舊金山分校健康中心總裁兼執行長 Suresh Gunasekaran 加入我們的董事會。

With over two decades of experience leading major academic medical centres, including some of the largest solid organ and bone marrow transplant programs in the United States, Suresh brings to the organization the voice of our customers, offering invaluable perspectives as we advance our strategy to become the solutions provider to transplant centres.

Suresh 擁有二十多年領導大型學術醫療中心的經驗，其中包括美國一些最大的實體器官和骨髓移植項目，他為本組織帶來了客戶的聲音，在我們推進成為移植中心解決方案提供商的戰略過程中，提供了寶貴的見解。

In addition, I was also pleased to welcome last month Dr. Jeff Teuteberg, our new Chief Medical Officer. Jeff is one of the most forward-thinking clinicians in transplantation. He is internationally recognized for his track record of clinical innovation, research and patient advocacy and is joining us from Stanford University where he was section chief of heart failure, cardiac transplant and mechanical circulatory support since 2017.

此外，上個月我也很高興地迎來了新的首席醫療官傑夫·圖特伯格博士。傑夫是移植領域最具前瞻性的臨床醫生之一。他在臨床創新、研究和患者權益倡導方面取得了國際公認的成就，他此前在史丹佛大學擔任心臟衰竭、心臟移植和機械循環支援部門的主任，自 2017 年以來一直任職於該校。

Jeff has held prominent roles in the American Society of Transplantation and as the President of ISHLT or the International Society of Heart and Lung Transplant.

Jeff 在美國移植學會擔任重要職務，並曾擔任國際心肺移植學會 (ISHLT) 的主席。

His deep experience will be instrumental as we strive to establish non-invasive molecular testing as the standard of care in solid organ transplantation and launch our next generation of precision medicine assays in stem cell transplant.

他豐富的經驗將對我們努力將非侵入性分子檢測確立為實體器官移植的標準治療方法，以及推出下一代幹細胞移植精準醫療檢測起到重要作用。

The expertise and vision of these leaders reinforce our commitment to innovation in both new products and how we go to market and engage our customers. Now on to the third quarter results. Total revenue of $100.1 million grew 21% year-over-year.

這些領導者的專業知識和遠見卓識，增強了我們對新產品創新以及市場推廣和客戶互動方式的承諾。接下來是第三季業績。總收入達 1.001 億美元，年增 21%。

Adjusted EBITDA was $15.3 million, more than double Q3 last year. We repurchased an additional 2 million shares during the quarter at an average price of $12.87.

調整後 EBITDA 為 1530 萬美元，是去年第三季的兩倍多。本季我們以平均每股 12.87 美元的價格回購了 200 萬股股票。

Year-to-date, we have repurchased approximately 9% of shares outstanding. Today, we are raising 2025 revenue guidance to $372 million to $376 million, a reflection of our strong performance in the third quarter. We are also raising adjusted EBITDA guidance to $35 million to $39 million.

今年迄今為止，我們已回購了約 9% 的流通股。今天，我們將 2025 年營收預期上調至 3.72 億美元至 3.76 億美元，這反映了我們第三季的強勁業績。我們同時將調整後 EBITDA 預期上調至 3,500 萬美元至 3,900 萬美元。

Nathan will provide additional details on the guide in his prepared remarks. In Testing Services, revenue was $72.2 million for the third quarter, an increase of 19% year-over-year.

內森將在事先準備好的演講稿中提供有關該指南的更多細節。測試服務業務第三季營收為 7,220 萬美元，較去年同期成長 19%。

We delivered approximately 50,300 tests in the third quarter, up 13% year-over-year, with growth across all three organs: heart, kidney and lung. I personally visited 20 transplant centres in the third quarter. I spoke with the clinicians and transplant program administrators to understand how our existing and future solutions can help improve the care of their patients.

第三季我們進行了約 50,300 次檢測，較去年同期增加 13%，心臟、腎臟和肺部這三個器官的檢測量均有所增加。第三季我親自走訪了20家移植中心。我與臨床醫生和移植計畫管理人員進行了交談，以了解我們現有和未來的解決方案如何幫助改善他們患者的照護。

Their feedback was clear. Our team is highly engaged, consistently puts patients first and is executing on the right priorities.

他們的回饋很明確。我們的團隊積極投入，始終把患者放在第一位，並優先處理正確的事項。

I also spent time with our local commercial teams, gaining valuable insights into where our solution selling strategy is working and where we can further improve. These conversations reinforce my confidence in our strategy and our people and left me inspired and optimistic about the significant growth opportunities ahead.

我也花時間與我們當地的銷售團隊交流，深入了解我們的解決方案銷售策略在哪些方面行之有效，以及在哪些方面我們可以進一步改進。這些對話增強了我對我們的策略和團隊的信心，也讓我對未來巨大的成長機會充滿信心和樂觀。

This week at the American Society of Nephrology meeting, or ASN, we are launching HistoMap Kidney, a breakthrough tissue-based molecular test that exemplifies our commitment to end-to-end transplant care. By integrating advanced histopathology with molecular insights, we're empowering clinicians to make more precise and timely decisions for their patients.

本週，在美國腎臟病學會（ASN）會議上，我們將推出 HistoMap Kidney，這是一項突破性的基於組織的分子檢測，體現了我們對端到端移植護理的承諾。透過將先進的組織病理學與分子見解相結合，我們正在幫助臨床醫生為患者做出更準確、更及時的決策。

This is just one example of how CareDx is bridging the gap between diagnostics and patient outcomes, reinforcing our leadership in delivering comprehensive solutions across the transplant continuum.

這只是 CareDx 如何彌合診斷和患者結果之間差距的一個例子，鞏固了我們在移植全過程提供全面解決方案方面的領先地位。

HistoMap Kidney is built on the Banff human organ transplant gene set, a research tool adopted by transplant researchers globally and leverages gene expression profiling for deeper insights into immune activity and rejection phenotypes to inform clinical decision-making.

HistoMap Kidney 是基於 Banff 人類器官移植基因集構建，該基因集是全球移植研究人員採用的研究工具，它利用基因表現譜分析來深入了解免疫活性和排斥表型，從而為臨床決策提供資訊。

We built HistoMap Kidney to address a critical unmet need in transplant care. If a patient's kidney function declines after transplant, clinicians need clarity on the type of rejection. With HistoMap Kidney, doctors can use the original biopsy tissue to obtain a precise molecular readout, confirming the subtyping rejection from an FFPE sample. By providing objective actionable data, HistoMap Kidney helps reduce uncertainty in biopsy interpretation, gives clinicians and patients greater confidence in their diagnosis and next steps.

我們開發 HistoMap Kidney 的目的是為了解決移植護理中一個尚未滿足的關鍵需求。如果患者腎移植後腎功能下降，臨床醫師需要明確排除反應的類型。借助 HistoMap Kidney，醫生可以使用原始活檢組織來獲得精確的分子讀數，從而確認 FFPE 樣本的亞型分離結果。HistoMap Kidney 透過提供客觀可操作的數據，幫助減少活檢結果解讀的不確定性，使臨床醫生和患者對診斷和後續步驟更有信心。

It will be available starting in early '26 in a clinical study and then for commercial use later in the year. Also at ASN Kidney Week, CareDx Technologies will be showcased in five abstracts covering AlloSure and our AI-derived integrated risk assessment algorithm, AlloSure Plus. The abstracts will present new insights, including biomarker interpretation in the early post-transplant period, including in the setting of delayed graft function and new evidence supporting the use of AlloSure in combination with clinical data to predict antibody-mediated rejection.

該藥物將於 2026 年初開始進行臨床研究，隨後於當年稍後投入商業使用。在 ASN 腎臟週期間，CareDx Technologies 也將透過五篇摘要進行展示，內容涵蓋 AlloSure 和我們基於人工智慧的整合風險評估演算法 AlloSure Plus。摘要將介紹新的見解，包括移植後早期生物標記的解讀，包括移植功能延遲的情況，以及支持將 AlloSure 與臨床數據結合使用以預測抗體介導的排斥反應的新證據。

Further, AlloSure Kidney will be featured in new analyses from the KOAR registry, demonstrating its ability to predict long-term outcomes and in research demonstrating the use of AlloSure Kidney to facilitate the transition to immune suppression monotherapy in kidney transplant patients. Belatacept monotherapy is preferred by clinicians because of its demonstrated improved clinical efficacy and tolerability as compared to traditional regimens.

此外，AlloSure Kidney 將在 KOAR 註冊中心的新分析中亮相，以證明其能夠預測長期結果，並在研究中證明 AlloSure Kidney 可用於促進腎移植患者向免疫抑制單藥治療的過渡。由於與傳統療法相比，貝拉西普單藥療法已證實具有更高的臨床療效和耐受性，因此臨床醫生更傾向於選擇貝拉西普單藥療法。

This emerging evidence suggests AlloSure can be utilized to optimize immune suppression strategies and improve long-term outcomes for transplant recipients. In addition, an ASN abstract from Henry Ford Hospital in Detroit addresses whether donor kidney volume impacts AlloSure levels or one year graft function. This is particularly relevant in pediatric transplantation where size mismatch between donor and recipient has been a concern.

現有證據表明，AlloSure 可用於優化免疫抑制策略，改善移植受者的長期預後。此外，底特律亨利福特醫院的一篇 ASN 摘要探討了供腎體積是否會影響 AlloSure 水平或一年移植腎功能。這一點在兒科移植中尤其重要，因為捐贈者和受體之間的體型不匹配一直是一個令人擔憂的問題。

The study found that kidney size did not significantly affect AlloSure levels or graft function at one year, reinforcing the reliability of our non-invasive monitoring tools across a broad range of donor and recipient characteristics. These new data reflect our commitment to advanced transplant care through rigorous science and innovation.

研究發現，腎臟大小對一年後的 AlloSure 水平或移植功能沒有顯著影響，這進一步證實了我們的非侵入性監測工具在各種捐贈者和受體特徵方面的可靠性。這些新數據體現了我們致力於透過嚴謹的科學和創新，提供先進的移植護理。

We are proud to see our technologies validated across diverse clinical settings in patient populations and look forward to continuing to deliver meaningful solutions that improve transplant outcomes. Keeping with our commitment to evidence generation, I want to highlight a major milestone in heart transplantation. Just two weeks ago, the second study from the SHORE registry was published in the Journal of the American College of Cardiology Heart Failure.

我們很自豪地看到我們的技術在不同的臨床環境中對患者群體進行了驗證，並期待繼續提供有意義的解決方案，以改善移植結果。為了履行我們收集證據的承諾，我想重點介紹心臟移植領域的一個重要里程碑。就在兩週前，SHORE 註冊研究的第二項研究發表在《美國心臟病學會心臟衰竭雜誌》。

This is the largest prospective analysis of antibody-mediated rejection, or AMR, in heart transplantation ever published. The SHORE study evaluated over 2,200 heart transplant patients across 59 US centres, analysing nearly 25,000 biopsies and almost 9,000 paired AlloSure heart samples. This is truly a landmark data set.

這是迄今為止發表的關於心臟移植中抗體介導排斥反應（AMR）的最大規模前瞻性分析。SHORE 研究評估了美國 59 個中心的 2200 多名心臟移植患者，分析了近 25,000 例活檢和近 9,000 例配對的 AlloSure 心臟樣本。這真是一份具有里程碑意義的資料集。

What's most exciting is that SHORE validates HeartCare, which brings together AlloMap and AlloSure Heart as a noninvasive, clinically proven approach to heart transplant surveillance and context-driven decision-making. The data show that AlloSure Heart results are highly specific for diagnosing AMR.

最令人興奮的是，SHORE 驗證了 HeartCare，它將 AlloMap 和 AlloSure Heart 結合起來，作為一種非侵入性的、經臨床驗證的心臟移植監測和情境驅動決策方法。數據顯示，AlloSure Heart 檢測結果對診斷 AMR 具有高度特異性。

Elevated AlloSure Heart levels were strongly associated with biopsy-proven AMR and higher values correlated with more severe rejection. And when AlloSure is modestly elevated, a positive AlloMap can help identify those at risk for acute cellular rejection. These findings demonstrate that HeartCare can optimize biopsy utilization and clinical decision-making in heart transplant care.

AlloSure Heart 水平升高與切片證實的 AMR 密切相關，且數值越高，排斥反應越嚴重。當 AlloSure 略微升高時，陽性的 AlloMap 可以幫助識別有急性細胞排斥風險的患者。這些研究結果表明，HeartCare 可以優化心臟移植護理中的活檢利用和臨床決策。

Lastly, on the topic of evidence generation, I'm particularly proud of our leadership in response to the draft LCD policy for molecular testing for solid organ allograft rejection that was published in July. Our team delivered a comprehensive evidence-based comment letter that champions patient access to personalized care. We submitted the letter to policymakers ahead of the public comment period closed on August 31, and it remains accessible at caredx.com/lcdcommentletter.

最後，關於證據生成，我特別自豪的是，我們在響應 7 月發布的關於實體器官同種異體移植排斥反應分子檢測的 LCD 政策草案方面發揮了領導作用。我們的團隊提交了一份全面的、以證據為基礎的評論信，倡導患者獲得個人化照護。我們在 8 月 31 日公眾評議期結束前向政策制定者提交了這封信，該信仍可在 caredx.com/lcdcommentletter 上查閱。

We consider the draft policy to be a significant step forward in affirming coverage for surveillance testing without a tie to protocol biopsy. However, we noted that limits placed on surveillance testing conflict with clinical guidelines and restrict clinician decision-making in scenarios where patients have elevated risk of rejection. Specialty societies, key opinion leaders, advocacy groups, policymakers and patient stakeholders also submitted comment letters emphasizing concerns with the proposed limits.

我們認為該政策草案是向前邁出的重要一步，它確認了監測檢測的覆蓋範圍，而無需與方案活檢掛鉤。然而，我們注意到，對監測性檢測的限制與臨床指南相衝突，並且在患者有較高排斥風險的情況下限制了臨床醫生的決策。專業協會、意見領袖、倡導團體、政策制定者和患者利益相關者也提交了意見信，強調了對擬議限制的擔憂。

We urge policymakers to maintain coverage for combination molecular tests such as AlloMap Heart and AlloSure Heart. Our comments provided the latest evidence in clinical data, which demonstrates the testing with AlloMap Heart and AlloSure Heart, identifies rejection with greater accuracy than gene expression testing or donor-derived cell-free DNA testing alone, resulting in improved patient outcomes.

我們敦促政策制定者維持對 AlloMap Heart 和 AlloSure Heart 等組合分子檢測的醫療覆蓋範圍。我們的評論提供了最新的臨床數據證據，顯示使用 AlloMap Heart 和 AlloSure Heart 進行的檢測，比單獨進行基因表現檢測或供體來源的無細胞 DNA 檢測更能準確地識別排斥反應，從而改善患者的治療效果。

We continue to anticipate that the draft policy will be finalized in early 2026. On our earnings call last quarter, we commented on the likelihood of potential outcomes and the associated financial impacts and those expectations are unchanged today.

我們仍然預計政策草案將於 2026 年初最終定稿。在上個季度的財報電話會議上，我們對潛在結果的可能性以及相關的財務影響進行了評論，這些預期今天仍然保持不變。

We plan to provide an update on our long-range planned financial assumptions once the policy has been finalized. We remain committed to supporting the transplant community and have not and do not anticipate to observe any business impact as the draft policy comments are being evaluated and the policy is being finalized. Moving on to our initiatives to drive operational excellence.

一旦政策最終確定，我們將提供關於我們長期財務規劃假設的最新資訊。我們將繼續致力於支持移植群體，並且在評估政策草案意見和最終確定政策的過程中，我們過去沒有、將來也不會看到任何業務影響。接下來，我們將介紹我們為提升營運效率所採取的措施。

Placing our customer at the center of everything we do has driven us to improve our enterprise infrastructure and business processes to operate more efficiently. We continue to push forward with the launch of our EPIC instance to make it easier for healthcare providers to order CareDx testing and receive test results.

將客戶置於我們一切工作的中心，促使我們改善企業基礎設施和業務流程，從而更有效率地運作。我們將繼續推進 EPIC 系統的上線，以便醫療服務提供者更容易訂購 CareDx 檢測並接收檢測結果。

We have eight EPIC Aura transplant center connection projects in process now and are officially live at Boston Children's, the US's leading pediatric heart transplant program. Feedback from that pilot implementation has been exceptional. Because our EPIC order set is tailored to transplant centers, it makes the centre’s workflow simple and fast.

我們目前正在進行八個 EPIC Aura 移植中心連接項目，並且已在美國領先的兒科心臟移植項目——波士頓兒童醫院正式上線。試點實施的回饋非常好。由於我們的 EPIC 醫囑集是為移植中心量身定制的，因此可以簡化和加快中心的工作流程。

Since going live at Boston Children's, AlloSure Plus results are now available directly through EPIC Aura. Medical records are received automatically with each order and the center has seen a 20% reduction in order turnaround time and a 60% reduction in specimen holds. This is a great example of how we're making the clinician and patient experience better, not just faster.

自從波士頓兒童醫院上線以來，AlloSure Plus 的檢測結果現在可以直接透過 EPIC Aura 取得。每次下單都會自動收到醫療記錄，中心的訂單處理時間縮短了 20%，樣本保存時間縮短了 60%。這很好地體現了我們如何改善臨床醫生和患者的體驗，而不僅僅是加快速度。

We continue to expect roughly 10% of our total volume will be serviced through EPIC Aura integrations by year-end, and roughly 50% of total volume will be serviced through EPIC Aura integrations by year-end 2026.

我們預計到今年年底，我們總業務量的約 10% 將透過 EPIC Aura 整合提供服務；到 2026 年底，我們總業務量的約 50% 將透過 EPIC Aura 整合提供服務。

This quarter, we also made remarkable progress on revenue cycle management. Building on last year's foundational updates to the team and workflows, we've now begun automating key RCM processes with AI, streamlining claims submission, accelerating appeals and reducing manual intervention across the board. The investments are already delivering measurable results.

本季度，我們在收入週期管理方面也取得了顯著進展。在去年對團隊和工作流程進行基礎性更新的基礎上，我們現在已經開始利用人工智慧來實現關鍵RCM流程的自動化，簡化索賠提交流程，加快申訴速度，並全面減少人工幹預。這些投資已經取得了可衡量的成果。

This isn't just operational fine-tuning. This is a strategic move to unlock operational efficiency to drive margin expansion and support scalable growth as our testing volumes increase.

這不僅僅是操作上的微調。這是一項策略性舉措，旨在提高營運效率，從而擴大利潤率，並隨著測試量的增加支持可擴展的成長。

In the third quarter, we achieved improvements across all of our RCM KPIs compared to our benchmark periods, including an over 200% improvement in total appeals volume, a 60% improvement in claims submission time, a 600 basis point improvement in overall 0 pays, and a 1,300 basis point reduction in claims rejection rate.

第三季度，我們所有 RCM KPI 都比基準時期有所改善，包括申訴總量改善 200% 以上，索賠提交時間改善 60%，整體 0 付款改善 600 個基點，索賠拒絕率降低 1300 個基點。

We believe these wins are key leading indicators for the growth and predictability of average revenue per test and are beginning to emerge in our financial statements. Cash collections in the third quarter were exceptional with collections accelerating to 124% of testing services revenue.

我們認為這些勝利是衡量每次測試平均收入成長和可預測性的關鍵領先指標，並且已經開始在我們的財務報表中顯現出來。第三季的現金回收情況非常出色，回收率加速達到檢測服務收入的 124%。

Nathan will provide additional color on our expectations for revenue per test in his prepared remarks. I'll now turn to Patient and Digital Solutions, which includes our transplant pharmacy, software tools and remote patient monitoring services.

Nathan 將在事先準備好的演講稿中進一步闡述我們對每次檢測收入的預期。接下來，我將介紹病患和數位化解決方案，其中包括我們的移植藥局、軟體工具和遠距病患監護服務。

In the third quarter, we reported revenue of approximately $15.4 million, representing 30% growth compared to last year. Our solution selling strategy is driving strong results. By delivering integrated Patient and Digital Solutions, we're unlocking new growth opportunities for testing services, deepening customer loyalty and strengthening our brand equity.

第三季度，我們的營收約為 1,540 萬美元，比去年同期成長了 30%。我們的解決方案銷售策略正在取得顯著成效。透過提供一體化的患者和數位解決方案，我們正在為檢測服務釋放新的成長潛力，加深客戶忠誠度，並增強我們的品牌價值。

For example, at the largest kidney program and Pediatric Institute in Georgia, we have become the pharmacy of choice for the kidney transplant program to help more efficiently and effectively manage their post-transplant patients as they ramped up their kidney transplant volume and initiated an AlloSure Kidney surveillance protocol.

例如，在喬治亞州最大的腎臟計畫和兒科研究所，我們已成為腎移植計畫的首選藥房，幫助他們更有效率、更有效地管理移植後患者，因為他們增加了腎移植數量並啟動了 AlloSure 腎臟監測方案。

Next, in lab products, which includes PCR kits for rapid disease donor HLA typing, NGS kits for transplant recipient HLA typing globally, and IVD monitoring assays for solid organ and stem cell transplant recipients outside the US, revenue of $12.5 million was up 22% year-over-year.

其次，在實驗室產品方面，包括用於快速疾病供體 HLA 分型的 PCR 試劑盒、用於全球移植受者 HLA 分型的 NGS 試劑盒以及用於美國以外實體器官和幹細胞移植受者的 IVD 監測檢測，收入為 1250 萬美元，同比增長 22%。

We just returned from ASHI, the American Society of Histocompatibility and Immunogenetics Annual Conference, where we showcased CareDx's continued investment in creating life-changing solutions. This year at ASHI, we launched AlloSeq Tx11, our next-generation HLA typing solution with enhanced Class II coverage and expanded non-HLA markers to support broader transplant organ profiling.

我們剛從美國組織相容性和免疫遺傳學學會年會 (ASHI) 回來，在會上我們展示了 CareDx 在創造改變生活的解決方案方面持續投入的成果。今年在 ASHI 上，我們推出了 AlloSeq Tx11，這是我們的下一代 HLA 分型解決方案，具有增強的 II 類覆蓋範圍和擴展的非 HLA 標記，以支援更廣泛的移植器官分析。

AlloSeq Tx11 is designed for flexibility working with low-quality samples preventing allele dropouts and reducing the need for retesting. We also introduced Score 7.0, our modernized analysis software for QType, built for scalability and regulatory alignment and supporting future ABO typing and IVDR compliance.

AlloSeq Tx11 的設計旨在靈活處理低品質樣本，防止等位基因流失，並減少重新測試的需要。我們還推出了 Score 7.0，這是我們為 QType 開發的現代化分析軟體，具有可擴展性和監管一致性，並支援未來的 ABO 血型鑑定和 IVDR 合規性。

In addition, we announced that AlloSeq TX and QType have received IVDR certification in the European Union, underscoring our commitment to delivering high-quality regulatory compliance solutions for transplant centers worldwide.

此外，我們宣布 AlloSeq TX 和 QType 已獲得歐盟 IVDR 認證，這凸顯了我們致力於為全球移植中心提供高品質的監管合規解決方案的承諾。

Our well-attended user group meeting entitled ABO Histocompatibility in transplantation, current status, unmet needs and future directions, featured leading experts from the Brigham and Women's Hospital, LifeLink Foundation and the University of Alberta.

我們舉辦了一場用戶小組會議，主題為“ABO 組織相容性在移植中的應用：現狀、未滿足的需求和未來方向”，與會者眾多，會議邀請了來自布萊根婦女醫院、LifeLink 基金會和阿爾伯塔大學的頂尖專家。

The session addressed the clinical relevance of ABO antibodies in transplant rejection, genotype versus phenotype discrepancies and the importance of advancing ABO blood typing for improved patient outcomes.

會議探討了 ABO 抗體在移植排斥反應中的臨床意義、基因型與表型差異以及推進 ABO 血型鑑定以改善患者預後的重要性。

Additionally, we announced our validation of a rapid ABO genotyping assay, which demonstrated 100% concordance with established methods and enables faster, more accurate blood group determination by integrating ABO and HLA genotyping into a single workflow we're helping transplant centers expand donor eligibility and streamline organ allocation, delivering real-world impact for patients and providers. This is the degree of innovation that defines CareDx and supports our confidence in continued strong lab products growth.

此外，我們宣布驗證了一種快速 ABO 基因分型檢測方法，該方法與既定方法 100% 一致，透過將 ABO 和 HLA 基因分型整合到單一工作流程中，能夠更快、更準確地確定血型。我們正在幫助移植中心擴大捐贈者資格並簡化器官分配，為患者和醫療服務提供者帶來實際影響。這正是CareDx的創新水平，也增強了我們對實驗室產品持續強勁成長的信心。

Before I hand it over to Nathan, I want to reflect on our recent progress. Each achievement this quarter is a direct result of our strategy in action and underscores the importance of keeping patient needs at the center of every decision. Our progress isn't just measured in numbers, but in real-world impact we're having on transplant patients, their families and the clinicians who care for them.

在把它交給內森之前，我想回顧一下我們最近的進展。本季所取得的每一項成就都是我們策略執行的直接結果，也凸顯了將病患需求置於所有決策核心的重要性。我們的進步不僅體現在數字上，更體現在我們對移植患者、他們的家人以及照顧他們的臨床醫生所產生的實際影響。

The growth we're seeing is not just the result of isolated initiatives, but of a cohesive approach where each decision and investment is anchored in delivering meaningful value for patients and their care teams.

我們看到的成長並非僅僅是孤立舉措的結果，而是整體方法的結果，其中每項決策和投資都以給患者及其照護團隊帶來有意義的價值為目標。

These growth drivers clearly demonstrate how our investments in innovation, optimizing our go-to-market approach, building and amplifying evidence generation and enhancing operational excellence through RCM progress and EPIC Aura integration are translating into meaningful impacts for patients, providers and the broader transplant community.

這些成長動力清楚地表明，我們在創新方面的投資、優化市場推廣方法、構建和擴大證據生成以及透過 RCM 進展和 EPIC Aura 整合來提高營運效率，正在轉化為對患者、醫療服務提供者和更廣泛的移植社區的有意義的影響。

They serve as proof points that our strategy is working and that we are building lasting value for all stakeholders, including our shareholders. Our leadership team has a proven track record of disciplined capital allocation and operational execution.

它們證明了我們的策略是有效的，並且我們正在為包括股東在內的所有利害關係人創造持久價值。我們的領導團隊在嚴格的資本配置和營運執行方面擁有良好的業績記錄。

We are confident that these strategic investments will yield a strong return, fuelling high-quality, durable growth for years to come. There is no shortage of work left to be done, but I'm proud of our execution so far this year and anticipate continued progress. Now I will turn the call over to Nathan to discuss our detailed financial results and guidance.

我們相信，這些策略投資將帶來豐厚的回報，為未來幾年的高品質、永續成長提供動力。雖然還有很多工作要做，但我對我們今年迄今為止的執行情況感到自豪，並期待繼續取得進展。現在我將把電話交給內森，讓他來詳細討論我們的財務表現和展望。

This is Nathan's first call as our CFO of CareDx. I'm thrilled to have him on the team and look forward to his leadership as we execute on our strategic and financial goals. Nathan?

這是 Nathan 作為 CareDx 的財務長打來的第一通電話。我很高興他能加入團隊，並期待在他的領導下，我們能夠實現策略和財務目標。內森？

Thank you, John, and good afternoon, everyone. It's an honor to be here, and I'm grateful for the opportunity to contribute to the value creation that's ahead for CareDx. Starting with financial highlights and key performance indicators for the third quarter compared to the prior year quarter, total revenue of $100.1 million increased 21% with all three business segments generating record quarterly revenue.

謝謝你，約翰，大家下午好。能夠來到這裡我感到非常榮幸，也很感激有機會為 CareDx 未來的價值創造貢獻力量。首先來看第三季的財務亮點和關鍵績效指標，與去年同期相比，總收入為 1.001 億美元，成長了 21%，所有三個業務部門都創造了創紀錄的季度收入。

Testing Services revenue of $72.2 million increased 19% on reported test volume of approximately 50,300, an increase of 13%. Revenue per test of 1,436 increased 5%.

測試服務收入為 7,220 萬美元，成長 19%，報告的測試量約為 50,300 次，成長 13%。每項測試的收入為 1,436，成長了 5%。

Revenue per test includes $5.9 million in revenue recognized from cash collections in excess of receivables on historical claims. This positive benefit was driven by the success of our revenue cycle management function that improved our cash collections on those historical claims.

每次測試的收入包括 590 萬美元的現金收入，該收入超過了歷史索賠應收款。這一正面影響源於我們收入週期管理職能的成功，該職能改善了我們對歷史索賠的現金回收。

We will be using the revenue per test metric that minimizes the back and forth of adjustments and better reflects the fundamentals of our business.

我們將採用每次測試的收入指標，以最大限度地減少調整的反复，更好地反映我們業務的基本面。

Continuing on Patient and Digital Solutions revenue of $15.4 million, increased 30% due to further adoption of the CareDx pharmacy as the pharmacy of choice for transplant patients. Lab product revenue of $12.5 million increased 22% driven by our distributed NGS transplant test kits and our PCR-based rapid HLA typing kits.

病患和數位解決方案收入持續維持 1,540 萬美元，成長 30%，這主要得益於 CareDx 藥局作為移植病患首選藥局的進一步普及。實驗室產品收入為 1,250 萬美元，成長了 22%，這主要得益於我們分銷的 NGS 移植測試試劑盒和基於 PCR 的快速 HLA 分型試劑盒。

Gross profit of $70.9 million reached a high watermark, increasing 190 basis points to 70.9%. This improvement was driven principally by top line performance and input cost discipline. Our non-GAAP operating expenses of $57.9 million declined to 58% of revenue, down from 63% of revenue.

毛利達 7,090 萬美元，創歷史新高，成長 190 個基點至 70.9%。這項改進主要得益於業績提升和投入成本控制。我們的非GAAP營運費用為5,790萬美元，佔營收的比例從63%下降到58%。

Adjusted EBITDA of $15.3 million increased significantly driven by revenue growth and operating leverage. Now turning to cash.

經調整後的 EBITDA 為 1,530 萬美元，主要得益於營收成長和營運槓桿作用。現在開始兌換現金。

We collected $119 million this quarter. Our RCM team achieved record collections of approximately $90 million from testing services. Those record collections drove $19 million in sequential reduction in our accounts receivable and a significant 38% improvement in DSOs, which improved from 71 to 44 days.

本季我們營收1.19億美元。我們的RCM團隊透過測試服務實現了約9000萬美元的創紀錄收入。這些創紀錄的收款使我們的應收帳款較上季減少了 1,900 萬美元，並使 DSO 顯著改善了 38%，從 71 天改善到 44 天。

That performance underscores the transformative impact of our investments to accelerate claim collection in RCM. We closed the third quarter with $194.2 million in cash and cash equivalents, following a $25.6 million share repurchase during the period.

這項績效凸顯了我們在 RCM 中加速索賠回收的投資所帶來的變革性影響。第三季末，我們持有現金及現金等價物1.942億美元，此前我們在該季度回購了價值2,560萬美元的股票。

We exited the quarter with 51.4 million shares outstanding and no debt. I'll turn next to guidance. With the strong performance in the third quarter, we now expect full year 2025 revenue of $372 million to $376 million. We also expect full year non-GAAP gross margins to be approximately 70%.

本季末，我們擁有 5,140 萬股流通股，且無任何債務。接下來我將講解指導原則。憑藉第三季的強勁表現，我們現在預計 2025 年全年營收將達到 3.72 億美元至 3.76 億美元。我們也預計全年非GAAP毛利率約為70%。

Turning to adjusted EBITDA. We are raising full year guidance range to $35 million to $39 million compared to the previous range of $29 million to $33 million to reflect the strong operating results in the third quarter. Updated full year guidance implies fourth quarter revenue of $101 million to $105 million.

接下來看調整後的 EBITDA。鑑於第三季強勁的經營業績，我們將全年業績預期範圍從先前的 2,900 萬美元至 3,300 萬美元上調至 3,500 萬美元至 3,900 萬美元。更新後的全年業績預期意味著第四季營收將在1.01億美元至1.05億美元之間。

That assumes fourth quarter testing volume will range between 52,000 to 54,000 tests. The strong momentum of RCM wins and cash collections are driving greater predictability and increasing our confidence in continued average revenue per test improvement.

假設第四季度的檢測量將在 52,000 到 54,000 次檢測之間。RCM 業務的成功和現金回收的強勁勢頭正在推動更大的可預測性，並增強我們對每次測試平均收入持續提高的信心。

In October, we had the highest cash collections for testing services in the company's history. In Q4 2025, we expect to recognize revenue per test of $1,400 to $1,420, inclusive of $4 million to $6 million of collections in excess of receivables.

10 月份，我們實現了公司歷史上最高的檢測服務現金收款金額。預計在 2025 年第四季度，每次測試的收入將達到 1400 美元至 1420 美元，其中包括超過應收帳款的 400 萬美元至 600 萬美元的收款。

We are taking a prudent approach to guidance on this metric to allow for potential variations in payer mix, coverage and contracts. Now turning to the other revenue lines. We expect Patient and Digital revenue of $15 million to $16 million, and lab products revenue of $12 million to $12.5 million.

我們對這項指標的指導採取了謹慎的態度，以應對支付方組合、覆蓋範圍和合約方面可能出現的變化。現在來看其他收入來源。我們預計患者和數位收入為 1500 萬美元至 1600 萬美元，實驗室產品收入為 1200 萬美元至 1250 萬美元。

We expect fourth quarter non-GAAP gross margins of approximately 70%. And finally, we anticipate fourth quarter adjusted EBITDA to range between $10 million to $14 million.

我們預計第四季非GAAP毛利率約為70%。最後，我們預計第四季度調整後 EBITDA 將在 1,000 萬美元至 1,400 萬美元之間。

To conclude my remarks, the momentum of the business at CareDx is robust. We are delivering a unique combination of top line expansion, margin improvement and OpEx management. Results in Q3 are a testament to the execution and our ability to scale efficiently while controlling costs.

最後我想總結一下，CareDx 的業務發展勢頭強勁。我們正在實現營收成長、利潤率提升和營運支出管理的獨特組合。第三季的業績證明了我們的執行力以及在控製成本的同時高效擴展業務的能力。

I'll now turn the time back over to John.

現在我把時間交還給約翰。

Thanks, Nathan. In closing, everything we've discussed today from our strategic execution to our operational progress reflects our unwavering commitment to putting patients first as the only transplant company offering end-to-end care.

謝謝你，內森。最後，我們今天討論的從策略執行到營運進展的所有內容，都體現了我們作為唯一一家提供端到端護理的移植公司，始終堅持將患者放在首位的堅定承諾。

The growth we're delivering is a direct result of strategies shaped by that North Star, and the impact is evident in the lives we touch, the partnerships we build and the innovations we bring to the transplant community.

我們所取得的成長，是這一北極星所指引的策略的直接結果，其影響體現在我們所幫助的人的生活、我們建立的夥伴關係以及我們為移植界帶來的創新中。

We remain focused on advancing the standard of care, deepening our relationships with clinicians and centers and driving sustainable value for all our stakeholders. With the right strategy, the right team and a clear sense of purpose, we are well positioned to lead the field and realize the full potential of CareDx.

我們將繼續致力於提升護理標準，深化與臨床醫生和中心的關係，並為所有利害關係人創造可持續的價值。憑藉正確的策略、合適的團隊和清晰的目標感，我們完全有能力引領業界，並充分發揮 CareDx 的潛力。

And with that, I'd like to open the call for questions.

接下來，我想開始接受提問。

(Operator Instructions) Andrew Brackmann, William Blair.

（操作說明）安德魯·布拉克曼，威廉·布萊爾。

Hi everyone, this is Maggie Boeye on for Andrew. You highlighted some of the wins on the revenue cycle management side of things and then some of the impact that has already shown up here both for the third and fourth quarter thus far.

大家好，我是Maggie Boeye，替我來為Andrew報站。您重點介紹了收入週期管理的一些成果，以及迄今為止在第三季和第四季已經顯現的一些影響。

How should we be thinking about the durability of those impacts on ASPs moving forward? And then as you sort of think about additional products which might exist, how do we think about the runway for further ASP lift from revenue cycle management initiatives moving forward?

我們該如何看待這些影響對ASP未來發展的持久性？然後，當您考慮可能存在的其他產品時，我們如何看待透過收入週期管理措施進一步提昇平均售價 (ASP) 的可能性？

Yeah, I'll take the first part of that and the durability of ASPs. Yes, as I mentioned in my prepared remarks, third quarter was a record quarter for us in terms of cash collections, and we saw that same momentum going into fourth quarter in October. Just over the last 6 months, we have seen an overall increase in our base revenue per test increased by 5%.

是的，我接受第一部分以及ASP的耐用性。是的，正如我在準備好的發言稿中提到的，第三季度是我們現金收款方面創紀錄的一個季度，而且我們在10月份進入第四季度時也看到了同樣的勢頭。在過去的 6 個月裡，我們看到每次測試的基本收入整體成長了 5%。

So what gives me confidence in the durability of that ASP is the strong cash collections on the historical claims that will ultimately increase that base ASP that we'll be recognizing on future claims. These RCM victories increase the predictability of our revenues per test over time, we see that momentum continuing through the fourth quarter and into 2026.

因此，讓我對平均售價的持久性充滿信心的，是歷史索賠的強勁現金回收，這最終將提高我們將在未來索賠中確認的基本平均售價。這些 RCM 的成功提高了我們每次測試收入的可預測性，我們看到這種勢頭將持續到第四季度，並延續到 2026 年。

Great. And then maybe just one on the EPIC Aura integration. I appreciate the comments so far on how it's been trending with your first pilot in Boston. But just -- how do we think about the rollout of the integration for the other accounts you have planned, both for 2025 and 2026? We've seen a lot of labs thus far have the major tailwind from these integrations.

偉大的。然後或許只需要專注在 EPIC Aura 的整合。我很感謝大家目前為止對你在波士頓的首次試點計畫的發展趨勢的評論。但是——我們該如何考慮您計劃在 2025 年和 2026 年推出的其他帳戶的整合方案？到目前為止，我們已經看到很多實驗室都從這些整合中獲得了巨大的發展動力。

So anything you can talk about there about what you're expecting?

所以，關於你即將發生的事情，你有什麼想說的嗎？

Yeah, thanks for the question, Maggie. I'm going to ask Keith to fill that one.

謝謝你的提問，瑪吉。我打算請基斯來填寫那份表格。

Thanks, Maggie. We have about 150 active discussions going on with hospitals and transplant centers across the country right now, and we anticipate going live at about 40 centers in '26. We agree there's typically a 10% uplift in volume once you go live, and we are tracking three major KPIs on each integration as we go, and we expect to sort of report and show that next year as we do these.

謝謝你，瑪吉。我們目前正與全國各地的醫院和移植中心進行約 150 場積極的討論，預計到 2026 年將在約 40 個中心投入使用。我們一致認為，一旦上線，銷量通常會提升 10%，我們正在追蹤每次整合過程中的三個主要 KPI，並預計明年在完成這些整合後會進行報告和展示。

But right now, we don't have enough implementations to give you real world evidence as to what that uplift is, but we were really excited to see that we had a 20% reduction in order turnaround time, which is really important to the centers. We're the leading transplant solid organ testing company in the United States and really globally with the fastest turnaround time.

但目前我們還沒有足夠的實施案例來提供實際證據來證明這種提升有多大，但我們很高興地看到訂單週轉時間減少了 20%，這對配送中心來說非常重要。我們是美國乃至全球領先的實體器官移植檢測公司，擁有最快的周轉時間。

So I was glad to see that we could further improve that. And then we had a 60% reduction in specimen holds, which contributes to the turnaround time and the improvement in that. So all really, really good things for our relationships and what we think it will impact volumes going forward.

所以我很高興地看到我們還能進一步改進這一點。然後，我們的樣本留存率降低了 60%，這有助於縮短週轉時間並提高週轉效率。所以，這對我們的關係以及我們認為它將對未來的交易量產生的影響來說，都是非常好的事情。

Great, thanks so much.

太好了，非常感謝。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, this is Vidyun on for Mark. Congrats on the nice quarter here. I just have a quick one. Were there any prior period collections in the quarter? Apologies if I missed it.

大家好，我是Vidyun，為您報道Mark。恭喜你們本季業績不錯。我還有一個簡短的問題。本季是否有前期收款？如果我錯過了，請見諒。

Yes. And Vidyun, thanks for joining us today. Yes, there were, as I mentioned in my prepared remarks, we had approximately $5.9 million in cash collections that exceeded our historical claims. It was a positive benefit.

是的。Vidyun，謝謝你今天加入我們。是的，正如我在準備好的演講稿中提到的，我們收到了約 590 萬美元的現金，超過了我們以往的索賠金額。這是一件好事。

Okay. Understood. And then just one follow-up on the ASP. I heard you on the Q4 ASP guide. Just should we be thinking about that kind of $1,400 level of the new floor moving forward?

好的。明白了。然後，就 ASP 進行了一次後續跟進。我在第四季ASP指南中聽到了你的聲音。我們是否應該考慮將新地板的價格定在 1400 美元左右？

And just in terms of the remaining upside in ASP, what kind of framework we should be using to think about it? I think your denial rate is about 40% right now. So just where do you think this can go at peak?

就 ASP 的剩餘上漲空間而言，我們該用什麼樣的框架來思考它呢？我認為你們目前的拒保率大約是40%。那你認為它在巔峰時期會發展到什麼程度？

Yes. Again, thank you, Vidyun, great questions there. So as I mentioned previously, the range that we guided to for fourth quarter is between $1,400 and $1,420 for our ASP, which you should be using in your models. Then as we think about the framework to be using, as we described, we're looking at this framework as a revenue per test. And so we're taking total revenue divided by total reported test, and that's the way we're looking at it because it removes the variability that we see in these out-of-period adjustments.

是的。再次感謝Vidyun，你提出的問題都很好。正如我之前提到的，我們預計第四季度的平均售價區間為 1400 美元至 1420 美元，你們應該在模型中使用該價格。然後，當我們考慮要使用的框架時，正如我們所描述的，我們將這個框架視為每次測試的收入。因此，我們將總收入除以報告的總測試次數，我們採用這種方法，因為它消除了我們在這些期間外調整中看到的波動性。

Okay, understood, thanks for taking the questions.

好的，明白了，謝謝你回答問題。

William Bonello, Craig Hallam.

威廉·博內羅，克雷格·哈勒姆。

Hey, a couple of questions. I'm just going to take another crack at that because I just want to make sure. So I think what you're saying is what we calculate as the ASP or the revenue per test is the revenue per test going forward. That's how we should think about it. But then you use the language of cash collections exceeding historical claims.

嘿，我有幾個問題。我打算再試一次，因為我想確保萬無一失。所以我覺得你的意思是，我們計算出來的每次測驗的平均售價或收入，就是未來每次測驗的收入。我們應該這樣想。但你卻用現金回收額超過歷史索賠額這樣的說法來描述這種情況。

Historically, I think you talked about prior period collections, sort of beyond what you would normally expect. I'm just trying to understand you're calling out is consistent with what you've called out in the past. Or if you're looking at that call out in a slightly different way. And if you're sort of saying, look, going forward, we're not going to be giving that call out. Apologize, I'm just a little confused by it.

從歷史角度來看，我認為你談到了前期收藏，這有點超出了人們通常的預期。我只是想確認你現在提出的要求是否與你過去提出的要求一致。或者，如果你從稍微不同的角度來看這個呼籲。如果你的意思是，從今以後，我們不會再發出這樣的呼籲了。抱歉，我有點不懂。

Yeah, thanks, Bill. It's John. Appreciate the question and the clarity. We're certainly going to call it out because we're going to be transparent.

謝謝你，比爾。是約翰。感謝您的提問與清晰的解答。我們一定會公開指出這一點，因為我們要做到透明公開。

You can see it on the books. So we did have the $5.9 million in prior period revenue that we collected, but we -- as you know, when RCM function really starts cranking like we've got it going, we're going to collect this cash, which we view to be indicative of future period ASP.

你可以在書上看到。所以，我們確實收到了之前期間的 590 萬美元收入，但是——正如您所知，當 RCM 功能真正開始運轉起來時，就像我們現在這樣，我們將收到這筆現金，我們認為這可以作為未來期間 ASP 的指標。

And so this quarter, we had cash collection that was 124% of our revenue that we booked in the quarter. And as those claims age into the accrual window, we're going to continue to see that ASP propped up. So we're pointing toward revenue per test as the metric to look at because it's more indicative of what you're going to see in future quarters from the company.

因此，本季我們的現金回收額達到了本季確認收入的 124%。隨著這些索賠進入累積期，我們將繼續看到平均售價得到支撐。因此，我們建議以每次檢測的收入作為衡量指標，因為它更能反映公司未來幾季的業績表現。

Yes. Okay. I think that makes sense. And I mean there's evidence on prior period adjustments, good guys and bad guys, right? So okay. So nothing unusual is the bottom line about the $500 million in this period.

是的。好的。我覺得很有道理。我的意思是，有證據表明前期調整是合理的，有好人和壞人，對吧？好的。所以，這段時間的5億美元並沒有什麼特別之處。

That's correct.

沒錯。

Okay. That's helpful. And then just a different topic. I'm just curious, John or anybody if you have any sort of on the macro environment, if you have any thoughts on the overall trends we're seeing in transplant volume. Obviously, your volume growth is staying pretty strong, but the overall transplant volume seems to have really been low for a while now.

好的。那很有幫助。然後我們又聊了另一個話題。我只是好奇，約翰或其他任何人，你們對宏觀環境有什麼看法嗎？你們對目前看到的移植量整體趨勢有什麼想法嗎？顯然，你的植髮量成長動能依然強勁，但整體植髮量似乎已經持續低迷了一段時間。

And I know we don't see an immediate correlation to your volumes, but you would think at some point, if we don't see a recovery in transplant volume, that might influence the overall testing volumes. I'm just curious if you have thoughts on what's going on with the overall transplant demand or volume? And then just how you think about that in terms of your growth going forward?

我知道我們目前還沒有看到與你們的檢測量之間的直接關聯，但你們可能會認為，如果我們在某個時候看不到移植量的恢復，那可能會影響整體檢測量。我只是好奇您對目前整體移植需求或移植數量的情況有什麼看法？那麼，你如何看待這一點對你未來發展的影響呢？

Thanks, Bill. I appreciate the question. I'll first address our volumes, and then I'll talk about the macro. So as you know, this market is really just at the early innings of penetration. So we anticipate that our growth rates will continue to outpace the growth of the market overall for the foreseeable future.

謝謝你，比爾。感謝您的提問。我先談談我們的交易量，然後再談談宏觀經濟。如你所知，這個市場目前還處於滲透的早期階段。因此，我們預計在可預見的未來，我們的成長率將繼續超過整個市場的成長速度。

And when we think that that's not the case, we'll update you. But for right now, for as far as I can see, that's going to continue to be the scenario.

如果我們認為情況並非如此，我們會及時通知您。但就目前來看，這種情況還會持續下去。

In general, in the macro environment, we've seen transplant volumes across all three solid organs remain relatively flat year-over-year, maybe like 1% up or down depending on the organ. We had anticipated that we would see some acceleration here in the back half of the year, particularly in kidney transplant volumes that has not yet materialized.

總體而言，從宏觀角度來看，所有三個實體器官的移植量都保持相對平穩，每年可能只有 1% 的增幅或降幅，具體取決於器官。我們曾預期今年下半年會出現一些成長，尤其是在腎臟移植數量方面，但這種情況尚未出現。

And we speculate that some of that is a function of the media that has been attracted to this space and questioning the practices of some of the various entities that participate in the transplant market, and that has dampened the acceleration in kidney transplant volume that we would have expected from the IOTA program.

我們推測，部分原因是媒體被吸引到這個領域，並質疑參與移植市場的各種實體的做法，這抑制了我們原本預期透過 IOTA 計畫實現的腎臟移植數量的加速成長。

Now remember, that program is a six-year program. And so we've got a lot of runway to go on the impact of that policy given that we're only one quarter into a six-year program.

請記住，這是一個為期六年的計畫。因此，鑑於我們這項為期六年的計劃才進行了四分之一，我們還有很長的路要走，才能看到這項政策的影響。

So I still have confidence that we're going to see growth in the kidney transplant numbers over the course of this next two to three years as this comes to play. But you're right, it has not materialized as we had anticipated it would starting here in the third quarter of '25.

因此，我仍然相信，隨著這項政策的實施，未來兩到三年內腎臟移植數量將會增加。但你說得對，它並沒有像我們預期的那樣從 2025 年第三季開始實現。

Tycho Peterson, Jefferies.

泰科·彼得森，傑富瑞集團。

Hey, thanks. Couple on the models. So on the guidance, you obviously narrowed guidance last quarter, now you're raising. Can you maybe just talk on for the fourth quarter, how much of that is price collections, volume, just some of the nuances behind the guidance raise? And then any preliminary thoughts on '26 you can share?

嘿，謝謝。模特兒上的情侶。所以，關於業績指引，你們上個季度顯然縮小了指引範圍，現在又提高了指引。您能否再談談第四季度的情況，例如價格上漲、銷售成長以及業績預期上調背後的一些細微差別？那麼，對於2026年，你有什麼初步想法可以分享嗎？

Yeah, I'll take thanks, Tycho, and appreciate the question. Yes, let me clarify a little bit on that. As we guided to, let's talk about volume. We guided to fourth quarter volume of 52,000 to 54,000 with the midpoint being at 53,000. That would represent the midpoint approximately almost 17% increase year-over-year.

是的，謝謝你，泰科，也謝謝你的提問。是的，讓我稍微解釋一下。正如我們之前所引導的，讓我們來談談音量。我們預計第四季銷量為 52,000 至 54,000 輛，中位數為 53,000 輛。這將代表中點，大約比上年增長近 17%。

On the price element, we guided a price of $1,400 to $1,420. That price is inclusive of $4 million to $6 million in the cash collection benefit that we anticipate to receive, and that's based upon our early read of collections in our record month in October. And then for the other line items, we guided towards both on product, pharmacy and digital. It leads us to our overall revenue of $100 million to $105 million with $103 million being the midpoint.

在價格方面，我們的指導價格為 1400 美元至 1420 美元。該價格包含了我們預計將收到的 400 萬至 600 萬美元的現金回收收益，這是根據我們對 10 月份創紀錄的回收情況的初步估計得出的。至於其他項目，我們則分別從產品、藥局和數位化三個面向進行指導。由此得出我們的總收入為 1 億美元至 1.05 億美元，其中 1.03 億美元為中間值。

And on '26, any comments?

關於26號，大家有什麼看法？

In terms of '26, we're going to defer any discussion on 2026 until after the clarity on the LCD.

至於 2026 年，我們將推遲對 2026 年的任何討論，直到 LCD 的情況明朗化之後。

Okay. And then on net price collections, any color on modality, how much, traction is it of for kidney versus heart care versus lung?

好的。然後，關於淨價收集，任何顏色的模式，腎臟護理、心臟護理和肺部護理的吸引力有多大？

HeartCare is our mature product, and we get a higher reimbursement rate on HeartCare. But with our kidney product, that's our fastest-growing product now where we don't get as well reimbursed there. But we are seeing wins with our rev cycle management teams and improving those collection rates with kidney. So I would say that the mix -- the product reimbursement mix doesn't have a significant impact, maybe 1 or 2 to 3 percentage points on the total price.

HeartCare 是我們成熟的產品，HeartCare 的報銷率也更高。但是就我們的腎臟產品而言，它是我們目前成長最快的產品，但我們在該領域的報銷並不理想。但我們看到，我們的收入週期管理團隊取得了成功，並且透過腎臟移植提高了收款率。所以我認為，產品報銷組合不會產生重大影響，可能對總價的影響只有 1% 到 2% 到 3%。

Okay. And then I appreciate the comments earlier on IOTA. I guess, so how are you thinking about when that really does start to become more of a meaningful tailwind? I mean I know it's kind of over five years, but when do you think that really kicks in?

好的。我也很感謝之前關於 IOTA 的評論。我想，那麼你認為什麼時候這才能真正成為一股更有意義的順風呢？我知道這已經超過五年了，但你認為什麼時候才會真正開始運作呢？

I mean our expectation was that it was going to kick in beginning this quarter. There has been, as I described, some media turmoil around transplantation, particularly as regards this concept of like jumping the wait list, right?

我的意思是，我們原本預期它會從本季開始生效。正如我之前所描述的，媒體對器官移植，特別是關於插隊移植的概念，產生了一些爭議，對吧？

So going down the wait list to find a better match for an organ. And the centers, I think, slowed down some of their aggressiveness in transplantation in that regard because of the media attention to the issue.

所以，只能依照等候名單順序尋找更適合的器官。我認為，由於媒體對這個問題的關注，各中心在移植方面放慢了一些動力。

I believe that we've seen the government clarify their policy on that topic with the transplant centers and the OPOs that should lighten up the conservatism and allow them to get back to driving kidney transplantation more aggressively like we anticipate as a result of the IOTA program getting started. So I think here, as we go into the fourth quarter, we'll see a pickup and then into '26 more materially.

我認為我們已經看到政府就此問題向移植中心和器官獲取組織 (OPO) 澄清了政策，這應該會放鬆保守態度，使他們能夠像我們預期的那樣，隨著 IOTA 項目的啟動，更加積極地推動腎移植。所以我認為，進入第四季後，我們會看到回升，然後在 2026 年會有更實質的變化。

Okay. Last one is just if the LCD goes through, is the $15 million surveillance headwind only for Medicare? Or is that all patients? And if it's just for Medicare, and that will require a protocol change for surveillance at the testing centers, I guess, what prevents all centers from adjusting to the new protocol?

好的。最後一個問題是，如果LCD獲得通過，1500萬美元的監控阻力是否只會影響Medicare？還是說所有患者都這樣？如果這只是為了醫療保險，並且需要改變檢測中心的監測方案，那麼，是什麼阻止所有中心都適應新的方案呢？

Yeah, that's a great question. Thanks for that one, Tycho. So we have not seen any impact on utilization of the testing as a result of the LCD and we did not model a change in clinician behaviour and ordering. So the $15 million that we provided in the scenario that we described last quarter is really just a reimbursement headwind.

是的，這是一個很好的問題。謝謝你，泰科。因此，我們沒有看到 LCD 對檢測利用率產生任何影響，也沒有模擬臨床醫生行為和醫囑的變化。因此，我們在上個季度描述的情況中提供的 1500 萬美元實際上只是報銷方面的阻力。

We don't anticipate and we are not going to message to clinicians that they change their behaviour around utilization of the product because as you can see in the LCD, there is room to change that policy.

我們不會預期，也不會向臨床醫生傳達改變其產品使用行為的訊息，因為正如您在LCD中看到的那樣，該政策還有改變的空間。

So if the evidence emerges that suggests that patients should get seven tests in the first year in specific scenarios or in general because it improves patient outcomes, then that policy may be modified.

因此，如果出現證據表明，在特定情況下或一般情況下，患者應該在第一年接受七項檢查，因為這可以改善患者的治療效果，那麼政策可能會進行修改。

At that point in time, we wouldn't want to have to go back and reconvince clinicians that they should do seven tests instead of four. So we continue to promote the utilization of the product as it was validated under the ARTS protocol, which is seven tests in the first year and 4 in every subsequent year.

到那時，我們可不想再回頭去重新說服臨床醫生，讓他們做七項測試而不是四項測試。因此，我們繼續推廣該產品的使用，因為它已根據 ARTS 協議得到驗證，該協議規定第一年進行七次測試，之後每年進行四次測試。

Okay, that's helpful thanks. Thank you.

好的，很有幫助，謝謝。謝謝。

Mason Carrico, Stephens.

梅森·卡里科，史蒂芬斯。

Hi, good afternoon. This is Harrison on for Mason. I wanted to start, if you could provide some insight into the delta in patient testing frequency at centers with protocols in place versus those without protocols. And for some of the centers that were early in readopting protocols has testing frequency trended consistently higher towards your established testing protocols.

您好，下午好。這是哈里森替梅森上場。我想先問一下，您能否提供一些關於有規程的中心與沒有規程的中心在患者檢測頻率方面的差異的見解？對於一些較早重新採用檢測方案的中心來說，檢測頻率是否持續向已建立的檢測方案靠攏呢？

Hi Harrison, thanks for the question. Certainly, since we reinitiated promotion of kidney surveillance protocols and protocols testing in August of '24, we've seen growth in surveillance testing. And we commented last quarter that the growth in kidney surveillance or the growth in kidney volume in general was nearly 20% year-over-year and that's a function of the readoption of those surveillance protocols and utilization of the testing.

嗨，哈里森，謝謝你的提問。當然，自從我們在 2024 年 8 月重新開始推廣腎臟監測方案和方案測試以來，我們已經看到監測測試有所增加。我們在上個季度評論說，腎臟監測或腎臟體積總體增加了近 20%，這是由於重新採用了這些監測方案和檢測方法。

There are many, many centers more beyond just the 60 that have adopted formal protocols that utilize surveillance testing at their centers from CareDx, you have centers where perhaps there's 5 clinicians and three of them do kidney surveillance and two of them don't, right, and only order for cause. So there's heterogeneity in the use of the product even within some centers.

除了這 60 個中心之外，還有許多中心採用了 CareDx 提供的正式方案，在其中心使用監測測試。有些中心可能有 5 位臨床醫生，其中 3 位進行腎臟監測，而另外 2 位不進行腎臟監測，對吧？他們只在有需要時才進行腎臟監測。因此，即使在一些中心內部，該產品的使用情況也存在差異。

And so we have seen significant growth in the use of AlloSure Kidney across the market, and we believe that the bulk of that growth is a result today of readoption and reinitiation of those 60 surveillance protocols that we called out last quarter.

因此，我們看到 AlloSure Kidney 在整個市場上的使用量顯著增長，我們認為，這種增長的大部分是由於上個季度我們提出的 60 項監測方案的重新採用和重新啟動所致。

Got it. And then I know we've done IOTA a couple of times on this call, but have you seen any notable shifts in center behaviours now that, that model is rolled out anything such as increase in compromised organs? Have you seen early signs of these centers leaning more into blood-based monitoring?

知道了。我知道我們在這次通話中已經討論過 IOTA 好幾次了，但是隨著該模型的推廣，您是否觀察到中心行為有任何明顯的轉變，例如受損器官數量增加？您是否注意到這些中心開始更多地採用血液監測的早期跡象？

I think we saw in the first half of the year and second half of last year, increasing adoption of blood-based monitoring for surveillance in anticipation of the start of the IOTA program. But in the third quarter, we have not seen growth in transplant volume in kidney transplant as a result of IOTA program.

我認為，在今年上半年和去年下半年，隨著 IOTA 計畫的啟動，人們越來越多地採用基於血液的監測來進行監測。但第三季度，由於 IOTA 項目，我們沒有看到腎臟移植數量增加。

And to your comment around or your question around compromised organs, this gets to the point I made on the earlier question about these volumes.

至於你提到的器官受損問題，這與我之前關於這些體積的問題剛好相關。

The criticism that has been made in the media is around going down the wait list and providing compromised organs to patients that are down list rather than giving it to the patient at the top of the list because it's not a great match, right?

媒體批評的焦點在於，為了避免器官移植，應該把不合適的器官提供給等待名單上的病人，而不是先給名單上的病人，因為器官匹配度不高，對嗎？

Or that patient is 35 years old and rather giving them a compromised organ that's only going to last 10 years, wait for a better organ that's going to last then 30 or 40 years, right? So the media on this topic, I think, has somewhat sensationalized an issue that is not really an issue because as you know, when you have these compromised organs, they often go to patients that otherwise would not get an organ. And that's where we anticipate the IOTA program is going to drive growth in transplantation and the need for more intensive surveillance monitoring of those compromised organs.

或者說，這位病人已經 35 歲了，與其給他一個只能用 10 年的受損器官，不如等待一個能用 30 年或 40 年的更好的器官，對吧？所以我認為，媒體對這個問題的報導有些聳人聽聞，而這個問題實際上並不是一個問題，因為正如你所知，當這些器官受損時，它們通常會捐獻給那些原本無法獲得器官的患者。而我們預期 IOTA 計畫將推動器官移植的發展，並促使人們對受損器官進行更密集的監測。

We have not seen that come to fruition as of yet, albeit we're only three months into the initiation of this program.

儘管該計畫啟動至今僅三個月，但我們尚未看到這一目標實現。

Got it thanks for taking the questions.

明白了，謝謝你回答問題。

Brandon Couillard, Wells Fargo.

Brandon Couillard，富國銀行。

Hey, thanks. Good afternoon. I just want to clarify one more time the prior period impact. So if I think about this right, the $6 million in the third quarter and then the other $4 million to $6 million in the fourth quarter, that's incremental relative to the prior guidance, right, which you increased $4 million at the midpoint, but then you've got kind of $12 million of good guys that will be incremental versus the prior guide, correct?

嘿，謝謝。午安.我只想再次澄清一下前一時期的影響。所以如果我理解正確的話，第三季的 600 萬美元，以及第四季的 400 萬到 600 萬美元，相對於之前的預期是增量的，對吧？你們把中間值提高了 400 萬美元，但還有大約 1200 萬美元的額外收入，相對於之前的預期也是增量的，對嗎？

Thanks, Brandon, for the question. We're including the prior period revenue in the guide. And so we raised the guide as a function of the collection of those -- that prior period revenue.

謝謝布蘭登的提問。本指南中包含了上期收入。因此，我們根據前期收入的收集情況提高了指導價。

Okay. And John, we've talked about kind of the weaker market to liver transplant procedure volumes. Perhaps that's why you've sort of come in towards the lower end of your sequential volume growth expectations in 3Q and kind of the implied 4Q guidance. I just want to make sure it's more of a softer market as opposed to a competitive dynamic. Could you speak to that element?

好的。約翰，我們之前討論過肝臟移植手術量相對疲軟的市場狀況。也許正因如此，你們第三季的銷售成長預期和第四季的隱含指引才略低於預期。我只是想確保這是一個較為溫和的市場，而不是一個競爭激烈的市場。您能談談這方面嗎？

Yeah, absolutely. I don't think it's a competitive dynamic or a softer market. I think it was just a function of the seasonality in the business. Like we had a really exceptional July, and then we saw things just soften in August and September, and we expected a pickup and it didn't occur.

是的，絕對的。我不認為這是競爭態勢或市場疲軟的表現。我認為這只是業務季節性波動所造成的。就像我們經歷了一個非常出色的七月份，然後我們看到八九月市場開始走軟，我們原本期待市場會回暖，但這種情況並沒有發生。

And therefore, we're maybe like 0.5 point off of where we expected to end the quarter, 1 point or 0.5 point off from where we expected to end the quarter based on what we did in July from a volume perspective.

因此，我們本季末的實際業績可能比預期低了 0.5 個百分點，或比根據 7 月銷售狀況預期的低了 1 個百分點或 0.5 個百分點。

But it's not a function of a competitive dynamic. If anything, we're gaining accounts and really gaining accounts that as I described previously, went away from surveillance testing to for cause testing and now have turned back on surveillance, which is driving our growth in the kidney business line, in particular, where we saw another quarter of nearly 20% growth year-over-year in our kidney business.

但這並非競爭動態的結果。如果有什麼變化的話，那就是我們正在獲得更多客戶，而且是真正獲得更多客戶，正如我之前所描述的，這些客戶從監測性檢測轉向了有針對性的檢測，現在又重新轉向了監測性檢測，這推動了我們腎臟業務線的增長，尤其是在腎臟業務方面，我們看到腎臟業務又一個季度同比增長了近 20%。

And then just one on the pipeline, the HistoMap Kidney launch next year. Do you expect that to be a revenue driver? Or what do you need to generate in terms of data to reimbursement for that product?

還有一款產品正在研發中，那就是明年即將推出的 HistoMap 腎臟產品。你認為這會成為營收成長的驅動因素嗎？或者，您需要產生哪些資料才能獲得該產品的報銷？

I do think it will -- thanks for the question, I do think it will generate revenue for the company, albeit nowhere near AlloSure sized revenue because this is a test that will only be utilized in the setting of a patient having an elevated AlloSure, they get a biopsy and then they order the gene expression testing off of the biopsy.

我確實認為它會——謝謝你的提問，我確實認為它會為公司帶來收入，儘管遠不及 AlloSure 的收入規模，因為這項測試只會用於 AlloSure 值升高的患者，他們會接受活檢，然後根據活檢結果進行基因表達測試。

And so we think this is a really valuable product, particularly as we see new -- potentially new CD38, anti-CD38 therapies coming to market for antibody-mediated rejection and clinicians will want to know the subtype of rejection genomically of that patient from the tissue prior to treating the patient therapeutically.

因此，我們認為這是一款非常有價值的產品，尤其是在我們看到新的產品——可能是新的 CD38、抗 CD38 療法即將上市，用於治療抗體介導的排斥反應時，臨床醫生會希望在對患者進行治療之前，從組織中了解該患者的基因組排斥反應亞型。

So we see a really interesting scenario there, kind of akin to comprehensive genomic profiling in the oncology market. So we're excited about HistoMap Kidney coming into play.

所以我們看到了一個非常有趣的場景，有點像是腫瘤市場的全面基因組分析。所以我們很高興 HistoMap Kidney 能投入使用。

We certainly will be striving to have that product reimbursed. And in the current LCD, there is a pathway for that, particularly in the language where it says in the setting of an inconclusive biopsy. And so that's our thinking today related to the product. But we'll provide guidance around 2026 revenues in our Q4 call likely.

我們一定會盡力爭取該產品的報銷。目前的LCD中有一條途徑可以實現這一點，尤其是在活檢結果不確定的情況下。這就是我們今天對這款產品的看法。但我們可能會在第四季財報電話會議上提供 2026 年營收的指導意見。

Great, thank you.

太好了，謝謝。

Yi Chen, HC Wainwright.

易晨，HC Wainwright。

Hi, this is [Katie] on for Yi. Could you quantify the impact the SHORE study had on test adoption or volume growth? And do you think that's a lasting impact on adoption trends? Or was that more of a short-term burn boost following that publication?

大家好，我是 Katie，為您帶來 Yi 的報導。您能否量化 SHORE 研究對測試採用率或測試量成長的影響？你認為這會對普及趨勢產生持久影響嗎？或者說，那隻是該文章發表後短期內的股價飆漲？

Thanks, Katie, for the question. The SHORE data has had a significant impact on the adoption of HeartCare in heart transplantation, dating back to April of 2024 at the ISHLT meeting where some of the initial data was first presented and we saw significant strength in our heart transplant business throughout the year 2024, and then coming into 2025. And so what you're seeing now is the product of multiple analyses of that data set in different contexts of use.

謝謝凱蒂的提問。SHORE 數據對心臟移植領域採用 HeartCare 產生了重大影響，可以追溯到 2024 年 4 月的 ISHLT 會議，當時首次展示了一些初始數據，我們在 2024 年全年以及進入 2025 年時，都看到了心臟移植業務的顯著增長。因此，您現在看到的是對該資料集在不同使用情境下進行多次分析的結果。

The first publication was focused on the utilization of biopsy and biopsy reduction. The second SHORE paper that was just published was focused on antibody-mediated rejection. And then the third SHORE paper, which has yet to be published, but the manuscript has been submitted is focused on long-term outcomes and graft survival and the prognosis of graft survival utilizing HeartCare. And we're very excited to see that publication in press hopefully before the end of the year.

第一篇出版物重點在於活檢的應用和活檢減少。剛發表的第二篇 SHORE 論文則聚焦在抗體介導的排斥反應。第三篇 SHORE 論文（尚未發表，但稿件已提交）重點關注長期結果和移植存活率以及利用 HeartCare 對移植存活率的預後。我們非常期待看到該出版物能在年底前付梓。

Thank you I appreciate that.

謝謝，我很感激。

Thank you.

謝謝。

And that will conclude our question-and-answer session and today's call. Thank you all for joining. You may now disconnect your lines.

我們的問答環節和今天的電話會議到此結束。感謝各位的參與。現在您可以斷開線路了。