CareDx Inc (CDNA) 2024 Q4 法說會逐字稿

Please stand by. We're about to begin. Good afternoon, everyone. Welcome to the CareDx Incorporated fourth quarter and fiscal year 2024 earnings conference call. (Operator Instructions) Also, today's call is being recorded.

請稍候。我們就要開始了。大家下午好。歡迎參加 CareDx Incorporated 2024 財年第四季和收益電話會議。（操作員指示）此外，今天的通話正在錄音。

Now at this time I'll turn things over to Miss Caroline Corner, Investor Relations. Please go ahead, ma'am.

現在，我將把事情交給投資者關係部 Caroline Corner 小姐。請繼續，女士。

Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the year ending December 31, 2024. The release is currently available on the company's website at www.caredx.com. John Hanna, President and Chief Executive Officer; and Abhishek Jain, Chief Financial Officer, will host this afternoon's call.

謝謝您，接線生。午安.感謝您今天加入我們。今天早些時候，CareDx 發布了截至 2024 年 12 月 31 日的年度財務表現。新聞稿目前可至本公司網站 www.caredx.com 查閱。總裁兼執行長約翰漢納 (John Hanna)；財務長 Abhishek Jain 將主持今天下午的電話會議。

Before we get started, I would like to remind everyone that management will be making statements during this call and include forward-looking statements within the meaning of the federal security laws which are made pursuant to the Safe Harbor of the Private Securities Litigation Reform Act of 1995.

在我們開始之前，我想提醒大家，管理階層將在本次電話會議中發表聲明，包括根據 1995 年私人證券訴訟改革法的安全港條款做出的聯邦安全法所定義的前瞻性聲明。

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, including without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing, and enrollment matters, and our financial expectations and results are based upon current estimates and various assumptions.

本電話會議中包含的任何非歷史事實陳述均應被視為前瞻性陳述。所有前瞻性陳述，包括但不限於我們對歷史營運趨勢的審查、對承保決策、定價和註冊事宜的預期以及我們的財務預期和結果均基於當前估計和各種假設。

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, should not play 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預期或暗示的結果有重大差異。因此，不應過度依賴這些聲明。

For a list and descriptions of the risks and uncertainties associated with our business, please see our filings of the Securities and Exchange Commission. The information provided in this conference call speaks only to live broadcast today, February 26, 2025.

有關與我們的業務相關的風險和不確定性的清單和說明，請參閱我們提交給美國證券交易委員會的文件。本次電話會議提供的資訊僅適用於今天（2025 年 2 月 26 日）的現場直播。

CareDx disclaims 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.

CareDx 不承擔任何意圖或義務，除非法律要求更新或修改任何資訊、財務預測或其他前瞻性陳述，無論是由於新資訊、未來事件或其他原因。

This call will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation of the most directly comparable GAAP financial measure may be found at today's earnings release filed with the SEC.

本次電話會議也將討論某些未依照公認會計原則計算的財務指標。最直接可比較的 GAAP 財務指標的對帳表可在今天向美國證券交易委員會 (SEC) 提交的收益報告中找到。

I will now turn the call over to John.

現在我將電話轉給約翰。

Thank you, Caroline, and welcome to everyone joining today's call. In early January, we pre-announced our fourth quarter and fiscal year 2024 financial results highlighting what was a transformational year for CareDx.

謝謝你，卡羅琳，歡迎大家參加今天的電話會議。1 月初，我們預先公佈了第四季和 2024 財年的財務業績，重點介紹了 CareDx 的轉型之年。

I want to start by congratulating the approximately 650 employees globally at CareDx for supporting the care of transplant patients from the early stages of establishing a donor to recipient match all the way through post-transplant monitoring, sometimes for the rest of the patient's life.

首先，我要祝賀 CareDx 全球約 650 名員工，他們為移植患者的護理提供支持，從建立捐贈者和接受者匹配的早期階段一直到移植後監測，有時甚至持續到患者的餘生。

We impacted the lives of over 50,000 patients in 2024 and in 2025 look forward to continuing to deliver on our mission to create life-changing solutions that enable transplant patients to thrive. In the fourth quarter, we reported quarterly revenue of $86.6 million up 32% year over year.

2024 年，我們影響了超過 50,000 名患者的生活，並期待在 2025 年繼續履行我們的使命，創造改變生活的解決方案，使移植患者能夠茁壯成長。第四季度，我們報告季度營收為 8,660 萬美元，年增 32%。

Positioned to build upon that performance, we reiterate our 2025 guidance of $370 million in revenue and our target to exit 2027 with $500 million in revenue and 20% adjusted EBITDA. At CareDx, we continue to drive gains in positive adjusted EBITDA due to revenue growth and disciplined management of our operating expenses and achieved $9.8 million in adjusted EBITDA in the fourth quarter and $27.8 million for the full year.

為了在此基礎上再接再厲，我們重申 2025 年 3.7 億美元收入的預期，以及 2027 年實現 5 億美元收入和 20% 調整後 EBITDA 的目標。在 CareDx，由於收入成長和對營運費用的嚴格管理，我們繼續推動正調整後 EBITDA 的成長，並在第四季度實現了 980 萬美元的調整後 EBITDA，全年實現了 2,780 萬美元。

We generated $22 million in cash from operations in the fourth quarter and ended the year with a cash balance of $261 million and no debt. We are committed to long-term profitable growth and in 2025 we expect an adjusted EBITDA gain of between $29 million and $33 million.

我們在第四季的經營活動中產生了 2,200 萬美元的現金，年底的現金餘額為 2.61 億美元，並且沒有債務。我們致力於實現長期獲利成長，預計 2025 年調整後 EBITDA 收益將在 2,900 萬美元至 3,300 萬美元之間。

I'm going to highlight several accomplishments from the fourth quarter and then turn to the key growth drivers for 2025 which you should anticipate hearing from me providing further commentary on throughout the year.

我將重點介紹第四季度的幾項成就，然後談談 2025 年的關鍵成長動力，您應該會在全年聽到我對此提供進一步的評論。

In testing services, we delivered approximately 45,500 tests in the fourth quarter, up 14% from the prior year. The fourth quarter was our sixth consecutive quarter of sequential testing services growth. We again experienced testing services volume growth across all organs, heart, kidney, and lungs. Testing services revenue was $63.8 million for the fourth quarter, up 37% year over year.

在檢測服務方面，我們在第四季度進行了約 45,500 次檢測，比上年增長了 14%。第四季是我們連續第六個季度實現測試服務成長。我們再次經歷了所有器官、心臟、腎臟和肺部檢測服務量的增長。第四季測試服務收入為6,380萬美元，較去年同期成長37%。

We completed our plan to add 30 sales and marketing team members to promote and sell our transplant solutions. We also completed the addition of 20 team members to our billing organization to drive greater collections and expand our ASP.

我們完成了增加 30 名銷售和行銷團隊成員來推廣和銷售我們的移植解決方案的計劃。我們還為我們的計費部門增加了 20 名團隊成員，以推動更多的收款並擴大我們的 ASP。

We will continue to invest in our commercial operations where we see an outsized opportunity to drive growth by further penetrating the market. We continue to make strides in [payer] coverage. In the fourth quarter, we expanded AlloMap Heart coverage from beginning its month six post transplant to month two post transplant by 21 million commercial lives and added 12.2 million new commercial covered lives for AlloSure.

我們將繼續投資於我們的商業運營，透過進一步滲透市場，我們看到了推動成長的巨大機會。我們繼續在[付款人]覆蓋範圍內取得進展。在第四季度，我們將 AlloMap Heart 的覆蓋範圍從移植後六個月擴大到移植後兩個月，覆蓋人數增加了 2,100 萬，並為 AlloSure 增加了 1,220 萬新的商業覆蓋人數。

For the full year 2024, we added our expanded coverage for 28 million lives for AlloMap Heart and added 36 million new commercial covered lives for AlloSure. This coverage and disciplined revenue cycle management will continue to drive our ASP in future quarters.

2024 年全年，我們為 AlloMap Heart 增加了 2,800 萬人的擴大覆蓋範圍，為 AlloSure 增加了 3,600 萬人的新商業覆蓋範圍。這種覆蓋範圍和嚴格的收入周期管理將在未來幾季繼續推動我們的平均售價。

Moving on to our patient and digital solutions which includes our transplant pharmacy, software tools, and remote patient monitoring services we reported revenue of approximately $11.4 million in the fourth quarter, representing 18% year-over-year growth.

談到我們的患者和數位解決方案，其中包括我們的移植藥房、軟體工具和遠端患者監控服務，我們報告第四季度的收入約為 1140 萬美元，同比增長 18%。

We continue to see strong synergies between patient and digital solutions and our testing services offerings. When accounts use three or more CareDx patient and digital solutions they have a 50% greater new patient capture rate for our testing services.

我們繼續看到患者和數位解決方案以及我們的測試服務產品之間的強大協同作用。當帳戶使用三個或更多 CareDx 患者和數位解決方案時，我們的測試服務的新患者捕獲率將提高 50%。

In the fourth quarter, our digital solutions team in collaboration with our partner, Leidos was awarded a contract by the US Department of Health and Human Services that provides us the opportunity to bid on projects associated with the Organ Procurement and Transplant Network or OPTN modernization initiative.

第四季度，我們的數位解決方案團隊與合作夥伴 Leidos 合作獲得了美國衛生與公眾服務部的一份合同，該合約為我們提供了競標器官採購和移植網絡或 OPTN 現代化計劃相關項目的機會。

This multi-year initiative aims to modernize the data collection, reporting, organ allocation, and other facets of the organ transplant system to better serve the more than 100,000 individuals on the national organ transplant waitlist.

這項多年計劃旨在實現器官移植系統的數據收集、報告、器官分配和其他方面的現代化，以便更好地服務於全國器官移植等候名單上的 100,000 多名個人。

This partnership leverages CareDx's deep expertise in transplant software development, data science, and AI, and Leidos experience in health systems and large scale health IT programs. We are proud to be a part of this initiative which has the potential to expand access to organ transplants.

此次合作利用了 CareDx 在移植軟體開發、數據科學和人工智慧方面的深厚專業知識，以及 Leidos 在醫療系統和大型醫療 IT 專案方面的經驗。我們很榮幸能夠成為這項有可能擴大器官移植機會的舉措的一部分。

Moving on to lab products which includes PCR kits for rapid disease donor HLA typing and NGS kits for transplant recipient HLA typing globally and IVD monitoring assays for solid organ and stem cell transplant recipients outside of the US. We reported revenue of $11.4 million, representing 23% year-over-year growth. Sales of our industry leading AlloSeq Tx NGS-based HLA typing kits for organ recipients primarily drove this growth.

接下來是實驗室產品，其中包括用於快速疾病供體 HLA 分型的 PCR 試劑盒和用於全球移植接受者 HLA 分型的 NGS 試劑盒以及用於美國以外實體器官和乾細胞移植接受者的 IVD 監測檢測。我們報告的收入為 1,140 萬美元，年增 23%。我們在業界領先的基於 NGS 的 AlloSeq Tx HLA 分型試劑盒（用於器官接受者）的銷售主要推動了這一成長。

In December, the results of a multi-center prospective study of our AlloSeq Tx cell-free DNA IVD kit which included 580 transplant patients from three referral centers in Europe, was published in the Journal Transplant International. The study demonstrated that AlloSeq cell-free DNA detects allograft rejection consistent with our AlloSure donor derived cell-free DNA lab-developed test in the US.

12月，我們的AlloSeq Tx遊離DNA IVD試劑盒的多中心前瞻性研究結果在《國際移植》雜誌上發表，該研究涵蓋了來自歐洲三個轉診中心的580名移植患者。研究表明，AlloSeq 遊離 DNA 可檢測出同種異體移植排斥反應，與我們在美國開發的 AlloSure 供體來源遊離 DNA 實驗室開發的測試一致。

Today, approximately 5% of CareDx revenue come from outside the US. However, there are over 18,000 kidney, 2000 heart, and 2000 lung transplants performed annually across the European Union alone. We look forward to these data expanding adoption of AlloSeq cell-free DNA for detecting allograph rejection in the same labs that use our industry leading AlloSeq Tx17 NGS HLA typing asset.

如今，CareDx 約 5% 的收入來自美國以外。然而，光是在歐盟，每年就有超過 18,000 例腎臟移植、2,000 例心臟移植和 2,000 例肺移植。我們期待這些數據能擴大 AlloSeq 無細胞 DNA 的應用，以便在使用我們業界領先的 AlloSeq Tx17 NGS HLA 分型資產的同一實驗室中檢測同種異體排斥。

The transition to NGS in HLA labs globally for HLA typing and the detection of allograft rejection will continue to drive growth in our lab products business. 2024 was a truly transformational year at CareDx and we believe we are well positioned for continued profitable growth in 2025.

在全球範圍內，HLA 實驗室轉向使用 NGS 進行 HLA 分型和檢測同種異體移植排斥反應，這將繼續推動我們實驗室產品業務的成長。 2024 年是 CareDx 真正轉型的一年，我們相信我們已準備好在 2025 年繼續實現獲利成長。

I now want to highlight what we view to be our key drivers of growth in 2025 that enable us to achieve our three-year long-range plan and that we've laid out in our presentation.

現在，我想強調我們認為的2025年成長的關鍵驅動力，這些驅動力使我們能夠實現我們在簡報中列出的三年長期計畫。

Number one is our go-to-market strategy to provide solutions to transplant centers across the care continuum to drive testing services volume growth. Our pharmacy, digital, and lab products are synergistic to growing our testing services adoption.

首要的是我們的行銷策略，為整個護理過程中的移植中心提供解決方案，以推動檢測服務量的成長。我們的藥房、數位和實驗室產品具有協同作用，可以提高我們測試服務的採用率。

Number two, evidence generation to expand payer coverage. We continue to demonstrate the testing services we provide improve patient health outcomes and provide significant value to the healthcare system. Evidence generation, coverage, and coding allow us to achieve in-network status and improve payment and ASP.

第二，產生證據以擴大付款人覆蓋範圍。我們將繼續證明我們提供的檢測服務能夠改善患者的健康狀況並為醫療保健系統提供重要價值。證據產生、覆蓋和編碼使我們能夠實現網路內狀態並改善支付和 ASP。

And number three, operational excellence to scale our business profitably, including business process optimization which allows us to have revenue growth, outpace operating expense growth, and generate cash. Throughout 2025 we anticipate achieving significant milestones in each of these areas.

第三，透過卓越營運擴大我們的業務獲利，包括業務流程優化，這使我們能夠實現收入成長、超越營運費用成長並產生現金。我們預計在 2025 年，每個領域都將取得重大里程碑。

First, in go-to-market strategy, through our synergistic offering of our patient and digital solutions we anticipate continued adoption and surveillance testing with AlloSure Kidney, namely, the IOTA program, which we anticipate will be implemented by CMS in July of 2025, is the current focus of most kidney transplant centers nationally. The program provides both upside and downside risk payments for transplant centers.

首先，在行銷策略方面，透過我們協同提供患者和數位解決方案，我們預計將繼續採用和監測 AlloSure Kidney，即 IOTA 計劃，我們預計該計劃將於 2025 年 7 月由 CMS 實施，這是目前全國大多數腎臟移植中心的重點。該計劃為移植中心提供上行和下行風險補償。

The two program metrics of importance are growing kidney transplant volumes and the organ acceptance rate at each center. Both of these metrics may drive centers to perform more complex transplant cases which may increase the risk of rejection. These patients may require more regular monitoring which we believe AlloSure Kidney is well positioned to support.

兩個重要的項目指標是不斷增長的腎臟移植量和每個中心的器官接受率。這兩個指標都可能促使中心進行更複雜的移植手術，這可能會增加排斥​​的風險。這些患者可能需要更定期的監測，我們相信 AlloSure Kidney 可以很好地提供支援。

Each performance year of the IOTA program is assessed independently so it is crucial that a transplant center understand their IOTA score in real time. CareDx's upcoming release of our quality reporting software, XynQAPI, is designed to specifically allow transplant centers to monitor their IOTA performance score in real time with no manual data entry required.

IOTA 計畫的每個績效年度都是獨立評估的，因此移植中心即時了解其 IOTA 分數至關重要。CareDx 即將發布的品質報告軟體 XynQAPI 旨在專門允許移植中心即時監控其 IOTA 效能分數，無需手動輸入資料。

This digital tool is an example of how our synergistic solutions are enabling sales engagements around expanding the use of our AlloSure surveillance testing services and is anticipated to be released prior to the July 2025 start of the IOTA program.

這個數位工具是我們的協同解決方案如何推動銷售活動以擴大我們的 AlloSure 監測測試服務的使用的一個例子，預計將在 2025 年 7 月 IOTA 計畫開始之前發布。

Another example of our patient and digital solutions that are driving engagement and kidney surveillance testing is the anticipated launch of our medication therapy management program through our CareDx transplant pharmacy.

我們推動參與和腎臟監測測試的患者和數位解決方案的另一個例子是，我們預計將透過 CareDx 移植藥房推出藥物治療管理計劃。

A key reason why transplant patients undergo organ rejection is the lack of adherence to their immune suppression medications which are often the result of symptoms of drug-to-drug interactions. The CareDx transplant pharmacy is launching a medication therapy management program in the first half of 2025 to support those patients, in particular, individuals with a less than ideal allograft match that are on a higher dose of immune suppression medication with greater side effects.

移植患者發生器官排斥的一個主要原因是沒有堅持服用免疫抑制藥物，而免疫抑制藥物通常是藥物交互作用症狀的結果。CareDx 移植藥局將於 2025 年上半年啟動一項藥物治療管理計劃，以支持這些患者，特別是那些移植匹配不太理想、需要服用較高劑量且副作用更大的免疫抑制藥物的患者。

In addition, we intend to launch several new products this year including in testing services AlloSure Heart for pediatric patients under the age of 15, AlloSure Kidney for simultaneous pancreas and kidney transplant patients which is primarily performed for patients with insulin dependent diabetes and renal failure.

此外，我們計劃今年推出幾款新產品，包括針對15歲以下兒科患者的檢測服務AlloSure Heart、針對同時進行胰臟和腎臟移植患者的AlloSure Kidney，主要針對胰島素依賴型糖尿病和腎衰竭患者。

And our HistoMap Kidney assay, a gene expression profiling test for determining molecular subtype of organ rejection, such as antibody mediated rejection. In our patient and digital solutions, we intend to expand the launch of AlloView, an AI risk prediction model for kidney allograft rejection.

我們的 HistoMap 腎臟檢測是一種基因表現譜測試，用於確定器官排斥的分子亞型，例如抗體介導的排斥。在我們的患者和數位解決方案中，我們打算擴大 AlloView 的推出，這是針對腎臟移植排斥的 AI 風險預測模型。

And in lab products we plan to provide commentary on the ongoing launch of our assigned 2.0 software that pairs with our AlloSeq Tx17 NGS assay for HLA typing and later in the year, the launch of Score 7, our next generation software for rapid PCR HLA testing.

在實驗室產品方面，我們計劃對正在推出的指定 2.0 軟體發表評論，該軟體與我們的 AlloSeq Tx17 NGS 檢測相結合，用於 HLA 分型，並在今年稍後推出 Score 7，這是我們用於快速 PCR HLA 檢測的下一代軟體。

Moving the evidence generation, I will start with kidney. In the fourth quarter, study investigators submitted the first of several anticipated manuscripts from the KOAR registry, a long-term follow-up study of nearly 4,000 patients who underwent kidney transplantation.

在證據生成方面，我將從腎臟開始。第四季度，研究人員提交了 KOAR 註冊中心幾份預期手稿中的第一份，這是一項對近 4,000 名接受腎移植的患者進行的長期追蹤研究。

We anticipate those data will be published in the second half of 2025, and the second KOAR manuscript is expected to be submitted in the second quarter of 2025. The major conference in kidney transplantation and additional abstract data that will lay the groundwork for future publications occurs in August of this year, the World Transplant Congress in San Francisco.

我們預計這些數據將於 2025 年下半年發布，第二份 KOAR 手稿預計將於 2025 年第二季提交。今年 8 月，在舊金山舉行的世界移植大會將是腎臟移植領域的重要會議，會議將提供未來出版物的基礎摘要。

In heart, we anticipate the second manuscript from the Shore registry to be submitted in the first half of 2025 and to be published in the second half of 2025. And in one we expect the manuscript to be submitted for publication in the second half of 2025. The International Society for Heart and Lung Transplantation, or ISHLT meeting is taking place in April 2025, where we expect data presented in abstract form to drive future publications in heart and lung.

我們預計 Shore 註冊處的第二份手稿將於 2025 年上半年提交，並於 2025 年下半年出版。我們預計稿件將於 2025 年下半年提交出版。國際心肺移植學會 (ISHLT) 會議將於 2025 年 4 月舉行，我們預計以摘要形式呈現的數據將推動未來心臟和肺部領域的出版物。

These data in kidney, heart, and lung will be the catalyst for additional commercial payer coverage for AlloSure as we continue to build the evidentiary library that demonstrates AlloSure testing changes clinician behaviors and improves patient health outcomes in each indication.

隨著我們繼續建立證據庫，證明 AlloSure 測試改變了臨床醫生的行為並改善了每種適應症患者的健康結果，這些腎臟、心臟和肺部數據將成為 AlloSure 額外商業付款人保險的催化劑。

Switching to our pipeline and CareDx's AlloHeme assay for hematologic malignancies, an interim one year readout of the two year AlloHeme ACROBAT trial to monitor for mini minimal residual disease recurrence for patients with hematologic malignancies that have undergone an allogeneic stem cell transplant was presented with the tandem cell transplant and cell therapy meetings last month.

轉向我們的產品線和 CareDx 的血液系統惡性腫瘤 AlloHeme 檢測，上個月的串聯細胞移植和細胞治療會議上展示了為期兩年的 AlloHeme ACROBAT 試驗的一年中期讀數，該試驗旨在監測接受同種異體幹細胞移植的血液系統惡性腫瘤患者的微小殘留疾病復發。

These interim data demonstrate AlloHeme detects relapse, a clinically meaningful time ahead of standard of care approaches. We anticipate further interim readouts of this trial throughout 2025 at scientific conferences. These data supporting AlloHeme will build the foundation for our future Medicare coverage submission following the completion of the ACROBAT trial in 2026.

這些中期數據表明 AlloHeme 可以檢測到復發，這比標準治療方法提前了臨床意義的時間。我們預計 2025 年的科學會議將對該試驗進行進一步的中期讀數。這些支持 AlloHeme 的數據將為我們在 2026 年 ACROBAT 試驗完成後未來提交的醫療保險覆蓋範圍奠定基礎。

In operational excellence, we are improving our enterprise infrastructure and business processes to operate more efficiently such that revenue growth outpaces operational expense as we scale. We have rebuilt our revenue cycle management team and look forward to seeing the impact that may have on ASPs in future quarters.

在卓越營運方面，我們正在改善企業基礎設施和業務流程，以提高營運效率，從而隨著規模的擴大，收入成長速度超過營運支出。我們已經重建了收入週期管理團隊，並期待看到其對未來幾季的 ASP 可能產生的影響。

And a key initiative in our supply chain operations is to increase the gross margins of our lab products business. If you recall, as a first phase, we transitioned AlloSeq TX-17 manufacturing from Fremantle, Australia to contract manufacturers in the US and EU to reduce COGS, and we now are taking additional steps in supply chain and manufacturing processes to improve our gross margin profile by the end of 2025.

我們供應鏈營運的關鍵舉措是提高實驗室產品業務的毛利率。如果您還記得，作為第一階段，我們將 AlloSeq TX-17 的製造從澳洲弗里曼特爾轉移到美國和歐盟的合約製造商，以降低銷貨成本，現在我們正在供應鏈和製造流程中採取額外措施，以在 2025 年底前改善我們的毛利率狀況。

And with that, I will now turn the call over to Abhishek to share more details on the fourth quarter and full year financial results in 2025 guidance. Abhishek?

現在，我將把電話轉給 Abhishek，讓他分享更多有關 2025 年第四季和全年財務業績指引的詳細資訊。阿布舍克？

Thank you, John. In my remarks today, I will discuss our fourth quarter and full year 2024 financial results before turning to 2025 guidance.

謝謝你，約翰。在今天的演講中，我將討論我們的 2024 年第四季和全年財務業績，然後再討論 2025 年的指引。

Unless otherwise noted, my remarks will focus on non-GAAP results. For further information, please refer to GAAP to non-GAAP reconciliation in our press release, earnings presentation, and recent SEC filings.

除非另有說明，我的評論將重點放在非公認會計準則結果。欲了解更多信息，請參閱我們的新聞稿、收益報告和最近的 SEC 文件中的 GAAP 與非 GAAP 的對帳。

Let me start with the key financial highlights. We reported fully at 2024 revenue of $334 million, up 19% year over year, exceeding the high end of our updated guidance. We delivered approximately 176,000 test results in 2024, up 6% year over year.

讓我先介紹一下主要的財務亮點。我們全面報告 2024 年的收入為 3.34 億美元，年增 19%，超過了我們更新後的指引的最高值。我們在 2024 年提供了約 176,000 份測試結果，年增 6%。

Test volumes grew 14% year over year in the fourth quarter to approximately 45,500 tests, representing the sixth consecutive quarter of sequential testing services volume growth. Testing services revenue was $249.4 million, up 19% year over year.

第四季測試量年增 14%，達到約 45,500 次，這是連續六個季度測試服務量實現增長。測試服務收入為2.494億美元，較去年成長19%。

Patient and Digital Solutions revenue was $43.6 million, up 18% year-over-year, and products revenue was $40.8 million, up 22% year over year. We reported an adjusted EBITDA gain of $27.8 million in 2024 compared to an adjusted EBITDA loss of $38 million in 2023.

患者和數位解決方案收入為 4,360 萬美元，年增 18%，產品收入為 4,080 萬美元，年增 22%。我們報告稱，2024 年調整後的 EBITDA 收益為 2,780 萬美元，而 2023 年調整後的 EBITDA 虧損為 3,800 萬美元。

Finally, we generated cash of $38 million in 2024 from operations, ending the year with $261 million in cash, cash equivalents, and marketable securities and no debt. Moving to the details, starting with gross margin.

最後，我們在 2024 年從營運中產生了 3,800 萬美元的現金，年底的現金、現金等價物和有價證券為 2.61 億美元，沒有債務。談細節，先從毛利率開始。

Our non-GAAP gross margin for the full year was 69.4%, up 280 basis points as compared to non-GAAP growth margin of 66.6% in 2023. The gross margin expansion was primarily driven by testing services. Our non-GAAP testing services gross margin was 78.9% in 2024 compared to 74% in 2023.

我們全年的非公認會計準則毛利率為 69.4%，較 2023 年的非公認會計準則成長率 66.6% 上升 280 個基點。毛利率的擴大主要得益於測試服務。我們的非 GAAP 測試服務毛利率在 2024 年為 78.9%，而 2023 年為 74%。

The improvement in testing services gross margin was driven by volume growth, ASP expansion, as well as continued efficiencies in managing our lab operations. Our Patient and Digital Solutions non-GAAP gross margin for '24 was 35% as compared to 36% in 2023.

測試服務毛利率的提高得益於銷售成長、ASP 擴張以及實驗室營運管理效率的持續提高。我們 2024 年的患者和數位解決方案非 GAAP 毛利率為 35%，而 2023 年為 36%。

Excluding our transplant pharmacy, which has a lower gross margin profile, our Patient and Digital Solutions non-GAAP gross margin for '24 was 59%. Our products non-GAAP margin for '24 was 49% as compared to 54% in 2023.

除毛利率較低的移植藥局外，我們 24 年的病患和數位解決方案非 GAAP 毛利率為 59%。我們產品 24 年的非 GAAP 利潤率為 49%，而 2023 年為 54%。

Moving down the P&L. Non-GAAP operating expenses for the year were $212 million, down approximately $21 million from 2023. Demonstrating the continued discipline in managing our operating expenses. The reductions in our operating expenses were driven principally by a reduction in legal spend.

降低損益表。全年非公認會計準則營業費用為 2.12 億美元，較 2023 年減少約 2,100 萬美元。展現我們在管理營運費用方面的持續紀律。我們的營運費用的減少主要是由於法律支出的減少。

Earlier this week, the district court reversed the jury decision in the patent litigation case brought by our competitor overturning the prior $96 million verdict. In our year in 2024 GAAP financial statements, we reversed the $96 million approved liability recorded in 2023, resulting in a positive GAAP net income of approximately $52.5 million for 2024.

本週早些時候，地方法院推翻了我們競爭對手提起的專利訴訟案的陪審團裁決，推翻了先前 9,600 萬美元的判決。在我們 2024 年 GAAP 財務報表中，我們撤銷了 2023 年記錄的 9,600 萬美元核准負債，導致 2024 年 GAAP 淨收入約為 5,250 萬美元。

Our adjusted EBITDA gain for the full year was $28 million as compared to adjusted bid a loss of $38 million in 2023. Adjusted EBITDA margin improved from a loss of 14% in 2023 to a gain of 8% in 2024. The improvement in adjusted EBITDA was driven by revenue growth and operational leverage, which contributed to better growth margins and non-gap operating expenses as a percent of revenue.

我們全年的調整後 EBITDA 收益為 2,800 萬美元，而 2023 年的調整後出價虧損為 3,800 萬美元。調整後的 EBITDA 利潤率從 2023 年的虧損 14% 改善至 2024 年的獲利 8%。調整後 EBITDA 的改善是由收入成長和營運槓桿推動的，這有助於提高成長利潤率和非缺口營運費用佔收入的百分比。

Turning to our cash balance, we ended the year in a strong position with cash, cash equivalents, and marketable securities of $261 million and no debt, an increase of approximately $26 million year over year. The increase in our cash balance was driven by strong cash flow from operating activities.

談到我們的現金餘額，我們以強勁的現金狀況結束了這一財年，現金、現金等價物和有價證券總額達到 2.61 億美元，且沒有債務，較上年同期增加了約 2600 萬美元。我們的現金餘額的增加是由經營活動產生的強勁現金流推動的。

Given the strong cash position and our confidence in the business, our board authorized another share buyback program in February 2025 of up to $50 million over two years. As a reminder, we repurchased approximately $29 million worth of shares in a previously approved shared buyback program that expired in December 2024 at an average price of $9.40 over a two-year period.

鑑於強勁的現金狀況和對業務的信心，我們的董事會於 2025 年 2 月批准了另一項股票回購計劃，兩年內回購金額高達 5000 萬美元。提醒一下，我們根據先前批准的共享回購計畫回購了價值約 2,900 萬美元的股票，該計畫將於 2024 年 12 月到期，兩年內平均價格為 9.40 美元。

Turning to guidance, we expect our revenue to be in the range of $365 million to $375 million in 2025. The midpoint of our '25 guidance assumes approximately 17% growth from our adjusted 24% revenue of $316 million. Our adjusted 2024 revenue excludes the $17 million in revenue associated with tests performed in prior periods.

談到指引，我們預計 2025 年我們的營收將在 3.65 億美元至 3.75 億美元之間。我們 25 年指引的中點假設我們的調整後營收 3.16 億美元將成長 24%，而成長率約為 17%。我們調整後的 2024 年收入不包括與前期進行的測試相關的 1700 萬美元收入。

Let me now provide more details on our '25 guidance. For testing services, we anticipate our test volumes to grow mid-teens year over year. We estimate our ASP to be approximately $1,360, a test on a blended basis for the full year.

現在，讓我提供有關我們的'25指導的更多詳細資訊。對於測試服務，我們預計測試量將逐年增長十五六成。我們估計我們的平均售價約為 1,360 美元，這是對全年混合基礎的測試。

We do expect to see some seasonality in our testing volumes. Additionally, in the first quarter so far, we have seen impacts from LA fires, snowstorms, and having midweek New Year holiday. We expect a modest growth of 2% to 3% in the first quarter, 5% to 6% in the second quarter, 2% to 3% in the third quarter, and 5% to 6% growth in the fourth quarter of 2025.

我們確實預計我們的測試量會出現一些季節性。此外，到目前為止，第一季我們已經感受到洛杉磯火災、暴風雪以及周中新年假期的影響。我們預計 2025 年第一季將溫和成長 2%-3%，第二季將成長 5%-6%，第三季將成長 2%-3%，第四季將成長 5%-6%。

On ASP, we expect $1,335 a test for Q1 '25 growing proportionately throughout the year. Also, this does not assume any changes to Medicare coverage. Our Patient and Digital Solutions and lab products revenue is expected to grow in the mid-teens year over year, approaching approximately $100 million in total.

就平均售價而言，我們預計 25 年第一季每項測試的價格為 1,335 美元，並將在全年按比例增長。此外，這並不假設醫療保險覆蓋範圍有任何變化。我們的患者和數位解決方案以及實驗室產品收入預計將年增15%左右，總額接近1億美元。

We expect our non-GAAP cost margin to be approximately 70% for the full year 2025. We're expecting our operating expenses to be approximately $235 million, an increase of approximately 11% year over year. We expect our adjusted EBITDA gained for the full year 2025 to be between $29 million and $33 million.

我們預計 2025 年全年非 GAAP 成本利潤率約為 70%。我們預計營運費用約為 2.35 億美元，年增約 11%。我們預計 2025 年全年調整後 EBITDA 將在 2,900 萬美元至 3,300 萬美元之間。

Q1 is generally our soft quarter due to reset of employee benefits, such as [401k] matching, payroll taxes, et cetera. Q1 of '25 will also have a full quarter impact of recent hires. We expect a low single-digit adjusted EBITDA in Q1, mid-single digit in Q2, high single digit in Q3 and remaining in Q4 of 2025.

由於員工福利的重新設定，例如[401k]匹配、工資稅等，第一季總體來說是我們的疲軟季度。25 年第一季的近期招聘也將對整個季度產生影響。我們預計 2025 年第一季的調整後 EBITDA 將為低個位數，第二季為中等個位數，第三季為高個位數，第四季保持不變。

With that, I would now turn the call over to John to deliver closing marks.

說完這些，我現在將發言權交給約翰來做結束語。

Thank you, Abhishek. At CareDx, we are deeply proud of the work we do to support the care of patients on their journey to a curative transplant. Earlier this month, we were honored to have Merle Zuel, one of our first AlloMap heart transplant patients, join us to celebrate the 18th year of the gift given to him, a newly transplanted heart.

謝謝你，阿布舍克。在 CareDx，我們為在患者接受治療性移植的過程中提供護理支援所做的工作深感自豪。本月初，我們很榮幸邀請到我們的首批 AlloMap 心臟移植患者之一 Merle Zuel 與我們一起慶祝他接受這份禮物——一顆新移植的心臟——的第 18 週年。

Merle is a father, grandfather, nurse and respected patient advocate for donors and recipients alike. He loves creating music and art, which he shared with our team. For the past 18 years, he has dedicated himself to living a rich and meaningful life, profoundly impacting the transplant community through his selfless volunteer efforts. It is the stories like Merle that inspire our employees every day to continue their important mission to create life-changing solutions that enable transplant patients to thrive.

梅爾是一位父親、祖父、護士，也是捐贈者和受助者尊敬的病人代言人。他熱愛創作音樂和藝術，並與我們的團隊分享。在過去的 18 年裡，他致力於過著豐富而有意義的生活，並透過無私的志工努力對移植界產生了深遠的影響。正是像梅爾這樣的故事每天激勵我們的員工繼續他們的重要使命，創造改變生活的解決方案，使移植患者能夠茁壯成長。

I would now like to ask the operator to open the line for questions.

現在我想請接線員開通熱線來回答問題。

(Operator Instructions)

（操作員指令）

Matt Sykes, Goldman Sachs.

高盛的馬特·賽克斯 (Matt Sykes)。

Hey guys. Congrats on the quarter. This is Prashant on for Matt. So you previously talked about multi-solution customer accounts generating more testing services revenue. Can you talk about your efforts in converting your existing accounts with less than three solutions to three or more solutions versus acquiring new customer accounts?

嘿，大家好。恭喜本季取得佳績。這是 Prashant 為 Matt 主持的。您之前談到過多解決方案客戶帳戶可以產生更多的測試服務收入。您能否談談您在將現有解決方案少於三種的帳戶轉換為三種或更多種解決方案以及獲取新客戶帳戶方面所做的努力？

So as we talked about in our prepared remarks, in our patient and digital solutions, we're really focused on our XynQAPI product for quality reporting and dashboarding that enables, in particular, kidney transplant centers to monitor their performance leading into the IOTA program where they now have the new metrics to assess.

因此，正如我們在準備好的發言中談到的那樣，在我們的患者和數位解決方案中，我們真正專注於我們的 XynQAPI 產品，用於品質報告和儀表板，這使得腎臟移植中心能夠監控其在 IOTA 計劃中的表現，現在他們有了新的指標來評估。

And then in addition, we shared how we're working on launching a medication therapy management program, which really is geared toward assisting patients that are having those pesky drug-to-drug interactions that cause them to skip taking immune suppression, which can lead to rejection.

此外，我們還分享了我們正在進行的一項藥物治療管理計劃，該計劃實際上是為了幫助那些因藥物間相互作用而導致他們不服用免疫抑製劑的患者，因為這種相互作用可能會導致排斥反應。

And so these types of patient and digital solutions, as they become more adopted at transplant centers across the country, we believe they're synergistic and will drive the use of AlloSure, be it in kidney, heart or lung.

因此，隨著這些類型的患者和數位解決方案在全國各地的移植中心得到越來越多的採用，我們相信它們具有協同作用，並將推動 AlloSure 的使用，無論是在腎臟、心臟還是肺部。

And as we've talked about since our Investor Day in October, we have put together a commercial team here that is focused on selling our total portfolio of solutions into each account. And so we really think this is going to be a catalyst for continuing to drive growth in 2025.

正如我們自十月的投資者日以來所談論的那樣，我們在這裡組建了一個商業團隊，專注於將我們的全部解決方案組合銷售到每個帳戶。因此，我們確實認為這將成為 2025 年繼續推動成長的催化劑。

Got it. That's helpful. And then my follow up is, can you talk about the impact on ASPs that launching these tests like AlloSure Heart Pediatric and AlloSure Kidney for simultaneous kidney and pancreas transplantation will have? I imagine you may initially have to provide some tests without reimbursement. So how large of a dilutive impact, if at all, will this have on gross margins in 2025?

知道了。這很有幫助。然後我的後續問題是，您能談談推出這些測試（如用於同時進行腎臟和胰腺移植的 AlloSure Heart Pediatric 和 AlloSure Kidney）對 ASP 的影響嗎？我想您最初可能必須提供一些不予報銷的測試。那麼，如果有的話，這對 2025 年的毛利率會有多大的影響呢？

Yeah, thanks for the question Prashanth. I think that that those two indications in particular AlloSure Heart Peds and AlloSure Kidney for simultaneous pancreas kidney are relatively smaller indications, but very important and high acuity conditions, right?

是的，感謝 Prashanth 提出的問題。我認為 AlloSure Heart Peds 和 AlloSure Kidney 用於同時進行胰腺腎臟治療這兩個適應症相對較小，但非常重要且病情嚴重，對嗎？

So a pediatric patient undergoing a heart transplantation, we anticipate that we'll be paid on those claims consistent with how we're paid on other commercial claims for AlloSure Heart and for AlloSure Kidney when a patient undergoes a simultaneous pancreas and kidney transplant. So we're not providing any guidance that that would have an impact negatively or positively on gross margins for '25.

因此，對於接受心臟移植的兒科患者，我們預計我們將獲得的索賠報酬與我們在患者同時接受胰臟和腎臟移植時獲得的 AlloSure Heart 和 AlloSure Kidney 的其他商業索賠報酬一致。因此，我們不會提供任何指導，表明這會對 25 年的毛利率產生正面或負面影響。

Tycho Peterson, Jefferies.

傑富瑞 (Jefferies) 的 Tycho Peterson。

Hey, this is Noah on for Tyco. Congrats on the quarter. I wanted to ask about, litigation, particularly with, the reversal. What is the path forward from here? If you're no longer on the hook for the $96 million and you have $200 million in cash, how are you thinking about capital allocation from there? I know you have the buyback authorization, but also what options are there and organic and also M&A.

嘿，我是 Tyco 的 Noah。恭喜本季取得佳績。我想問一下有關訴訟的問題，特別是撤銷的問題。下一步該怎麼做？如果您不再承擔 9,600 萬美元的責任，而且您擁有 2 億美元現金，那麼您將如何考慮資本配置？我知道您有回購授權，但是還有哪些選擇以及有機和併購。

Yeah, thanks Noah for the question. The path forward with any IP litigation, we anticipate that it will likely be appealed. However, our assessment is that having those patents invalidated is significant such that we reverse that accrual and believe along with our audit partners that that was the appropriate thing to do at this time.

是的，感謝 Noah 提出這個問題。對於任何智慧財產權訴訟的未來發展，我們預計它都有可能被上訴。然而，我們的評估是，這些專利的無效具有重大意義，因此我們扭轉了這種累積，並與我們的審計夥伴一起相信這是目前適當的做法。

In terms of -- your second question around the share buyback and capital allocation, it doesn't change our perspective on this, which I think we've talked about for several quarters. First and foremost, we're going to continue to reinvest in the business where we see opportunities for continued growth.

至於——您的第二個問題涉及股票回購和資本配置，這並沒有改變我們對此的看法，我想我們已經討論了幾個季度。首先，我們將繼續對有持續成長機會的業務進行再投資。

Second, we'll look for strategic opportunities in the marketplace adjacent to transplant or in that transplant plus field that we've described. And then third, if we don't see any opportunities to invest in the business or do strategic transactions, then we'll go to share buybacks and buy back shares as appropriate.

其次，我們將在與移植相鄰的市場或我們所描述的移植加領域中尋找策略機會。第三，如果我們沒有看到任何投資業務或進行策略性交易的機會，那麼我們就會進行股票回購並在適當的時候回購股票。

Great, that's helpful. And then for my follow up here, if I could just ask on new hires, I think you noted that you completed that in 4Q, and so I'm wondering about the ramp to see impact from new hires, particularly how that will play out first half or second half in 2025.

很好，很有幫助。然後，對於我的後續問題，如果我可以問一下有關新招聘的問題，我想您注意到您在第四季度完成了這項工作，所以我想知道新招聘的影響，特別是這將如何在 2025 年上半年或下半年發揮作用。

Absolutely, we typically see the new higher ramp in this space to be roughly six months to get them fully ramped up and effective in the field. As Abhishek commented in our prepared remarks, we've seen a little bit of disruption here in Q1 from weather and fires and events like that, but that also, has given us time to really focus on training call planning, field strategy, and the teams out there hitting the pavement and we expect to have a stronger quarter in in Q2.

當然，我們通常看到該領域的新更高成長大約需要六個月的時間才能完全實現並在現場發揮作用。正如 Abhishek 在我們準備好的發言中所說，我們在第一季度看到了一些來自天氣、火災和類似事件的干擾，但這也讓我們有時間真正專注於培訓呼叫計劃、現場策略和實地工作團隊，我們預計第二季度的表現會更強勁。

Mark Massaro, BTIG.

BTIG 的馬克馬薩羅。

Hey guys, thank you for taking the questions. Congrats on a good quarter. I wanted to hit the topic of prior period collections. Maybe, Abhishek, can you clarify how much might have hit in Q4? And then I think I heard you say the number for full year '24, but can you just repeat that? And then as we think about 2025, is there any, contribution for prior period collections in the guidance?

嘿夥計們，感謝你們回答問題。恭喜本季取得良好業績。我想要討論一下之前時期的收藏品這個主題。也許，Abhishek，您能否澄清一下第四季度可能受到多大的衝擊？然後我想我聽到您說出了 24 年全年的數字，但您能重複一遍嗎？然後，當我們考慮 2025 年時，指導中是否有任何前期收款的貢獻？

Thanks for the question mark. So on your first question, the Q4 revenue includes about $2.2 million in revenue which is associated with the tests that were outside of Q4. And what I've also called out that throughout the 2024 we recognized about $17 million in revenue. That was the test -- those were the tests that we had done prior to 2024. So that's the second part of the question.

謝謝你的問號。關於您的第一個問題，第四季度的收入包括約 220 萬美元的收入與第四季度以外的測試有關。我還提到，2024 年我們的收入約為 1700 萬美元。這就是測試——這就是我們在 2024 年之前所做的測試。這是問題的第二部分。

And the third and the last piece, mark in 2025 guidance, we are not baking in contribution from these one-timer tests, and that states one of the upsides.

第三點也是最後一點，在 2025 年的指導方針中，我們不會考慮這些一次性測試的貢獻，這顯示了其中的一個好處。

Okay, that's very helpful. And then I think I heard you guys talk about mid-teens volume for 2025 and ASPs of $1,360. I'd be curious to try to understand how much of that mid-teens volume is baking in increased surveillance testing? And then maybe more broadly, what are you seeing now that we're into the month of February. What are you seeing in the marketplace for surveillance testing here in Q1?

好的，這非常有幫助。然後我想我聽到你們談論 2025 年的中等銷量和 1,360 美元的平均銷售價格。我很好奇，想了解這 15 多個年齡層的孩子中，有多少是因為加強監測測試而產生的？然後可能從更廣泛的角度來看，現在我們已經進入二月份，您看到了什麼。您在第一季的監測測試市場上看到了什麼？

Yeah, thanks for the question, Mark. Thanks for joining the call today. Yes, we do believe that surveillance testing is going to contribute substantially to that mid-teens volume growth. In Q4, kidney testing outpaced all other organs, and we continue to have institutions that are turning on surveillance protocols through the quarter. And those institutions move at their own pace.

是的，謝謝你的提問，馬克。感謝您今天的電話會議。是的，我們確實相信監測測試將對十幾歲的中期數量增長做出重大貢獻。在第四季度，腎臟檢測超過了所有其他器官的檢測，並且我們繼續有機構在本季度啟動監測協議。這些機構按照自己的步調發展。

So as I've said previously, it's going to take us probably two to three quarters to turn those protocols back on. And then it's going to take time for new patients to get started on protocol and that volume to build through the course of the 12 months following the initiation of that protocol.

因此，正如我之前所說，我們可能需要二到三個季度的時間來重新啟用這些協議。然後，新患者需要時間來開始遵循治療方案，並且在該治療方案啟動後的 12 個月內，治療量也需要逐漸增加。

So we're on that journey. We feel really good about it. And going forward, that is a primary focus of our team in having those discussions and engagements and working through the workflow to get those protocols turned back on.

所以，我們正踏上這段旅程。我們對此感到非常高興。展望未來，這是我們團隊的主要關注點，進行這些討論和接觸，並透過工作流程重新啟用這些協議。

Okay, great. And then one last quick one. It looks like you just provided a $5 million buffer on the guidance. I think you preannounced a rev guide of $370 million, and now it's $365 million to $375 million. Maybe just the rationale for that. Maybe it's due to weather or other variability. But can you also just explain what you think some of the levers are to the upper end and the lower end of the guide?

好的，太好了。最後再簡單說一下。看起來您剛剛在指導價上提供了 500 萬美元的緩衝。我認為您預先宣布的收入指南是 3.7 億美元，而現在是 3.65 億至 3.75 億美元。也許這只是一個理由而已。這可能是由於天氣或其他變化造成的。但是，您能否解釋一下您認為導軌上端和下端的一些槓桿是什麼？

So at the midpoint of our guide, the $370 million what we have basically called out, of course, the mid-teens, the 17% growth from the adjusted 2024 revenue. And if I were to bridge the low end and the high end of the guide, that's about $5 million difference. And I'm assuming plus, minus 1% on the volume, plus, minus 0.5 percentage point on the ASP, and there is a small portion in the non testing services. That basically makes up the $5 million.

因此，在我們的指導中點，即 3.7 億美元，我們基本上已經預測到了中等水平，即比調整後的 2024 年收入增長 17%。如果我要彌合指南的低端和高端之間的差距，那麼差距就大約是 500 萬美元。我估計銷售量會有正負 1% 左右的變化，平均售價會有正負 0.5 個百分點的變化，而且還有一小部分屬於非測試服務。這基本上就是 500 萬美元。

All right, thanks for taking.

好的，謝謝您的收看。

The call. Yeah, no, it's a great question. I think on the upside, it's really about the speed at which surveillance in kidney comes back on and how effective we are with the new billing organization that we've built with a focus on operational excellence to go out and collect cash.

電話。是的，不，這是一個很好的問題。我認為，從好的方面來看，這實際上關乎腎臟監測的恢復速度，以及我們建立的新計費組織的效率，該組織專注於卓越運營，出去收取現金。

As our reimbursement rate at $1360 that we've suggested for the year is less than half of our Medicare reimbursement rate. And so we think there's a lot of opportunity there, but it's very difficult to forecast ASP, but it's something we're really focused on here in the organization.

因為我們建議的年度報銷率為 1360 美元，還不到我們醫療保險報銷率的一半。因此，我們認為這裡有很多機會，但很難預測 ASP，但這是我們組織真正關注的事情。

Bill Bonello, Craig-Hallum.

比爾波尼洛、克雷格哈勒姆。

Hey guys, thanks a lot, a couple of questions. First of all, just following up on the ASP front, that assumes it's pretty flat, which again makes total sense in terms of a guide. But what things you talked about adding and reorganizing the billing team.

嘿夥計們，非常感謝，我有幾個問題。首先，僅從 ASP 方面進行跟踪，假設它相當平穩，這對於指南而言再次完全合理。但是您談到了增加和重組計費團隊的事情。

And you obviously made really good strides last year. So can you just lay out for us a little bit what some of the opportunities or the most important opportunities you have to improve revenue capture?

顯然，去年你取得了很大的進步。那麼您能否為我們稍微闡述一下您在提高收入獲取方面有哪些機會或最重要的機會？

Yeah absolutely thanks for the question and thanks for joining today. We brought in a new leader for the team to up-level the skill set across the organization. And it's really about understanding what are the dials and knobs that can drive cash collection and billing.

是的，非常感謝您的提問，也感謝您今天的參加。我們為團隊引入了一位新領導者來提升整個組織的技能水準。這實際上就是要了解哪些刻度盤和旋鈕可以推動現金收集和計費。

What are the right appeal letters that get claims and aisles overturned? What are the steps in the process? Are we appealing the claims in a timely manner so that we don't miss the timely filing deadline? There's a lot of what I would call like industrial engineering operations work that goes into the billing workflow and processes in these organizations, and we needed to revamp ours and really get tight on what we're doing so that we can collect cash.

哪些正確的申訴信可以推翻索賠和判決？該過程的步驟是什麼？我們是否及時對索賠提出上訴，以免錯過及時提交的截止日期？這些組織的計費工作流程和流程中涉及大量我所說的工業工程營運工作，我們需要改進我們的工作流程，嚴格控制我們的工作，以便能夠收取現金。

And we think it's going to have an impact. We feel really good about the leadership team we've put in place and the talent we've been hiring. And now we're turning towards, okay, we've got to improve our systems and business processes in order to be able to collect that money.

我們認為這會產生影響。我們對已組建的領導團隊和聘用的人才感到非常滿意。現在我們要做的就是，好吧，我們必須改進我們的系統和業務流程，以便能夠收回這筆錢。

Do you have the appropriate teams in place that the individuals know which claims to work on and which ones are going to hit timely filing? So a lot of that detailed blocking and tackling is what we're working on right now.

您是否已建立適當的團隊，以便個人知道需要處理哪些索賠以及哪些索賠能夠及時提交？所以我們現在正在致力於大量詳細的阻擋和解決工作。

That's really helpful, And just as a follow-up on that, from the systems standpoint, I mean, I don't know what you guys use as a billing and collection system, but are the systems you have capable of implementing those sorts of tools? Or is part of what you're going to be doing, upgrading the systems themselves?

這真的很有幫助，作為後續問題，從系統的角度來看，我的意思是，我不知道你們使用什麼計費和收款系統，但你們的系統是否能夠實施這些工具？或者您要做的事情的一部分是升級系統本身？

Yes. The system is capable of it. We just upgraded our license and the modules we were using and then you can customize workflows in the system. So a lot of what we were doing was very basic out of the box previously and the team was under-resourced, and they were just collecting what they could.

是的。該系統有能力實現這一點。我們剛剛升級了我們的授權和我們正在使用的模組，然後您可以在系統中自訂工作流程。因此，我們之前所做的許多工作都是非常基本的，而且團隊資源不足，他們只是在收集他們能收集到的資源。

And so we came in and said, hey, the return here way outsizes the spend. Let's build up the team, let's upgrade the system, let's ensure we have the right talent that can build out the workflows and go execute and collect what's left there on the table.

於是我們來到這裡並說，嘿，這裡的回報遠遠超過了支出。讓我們建立團隊，讓我們升級系統，讓我們確保我們擁有合適的人才，可以建立工作流程、執行和收集剩餘的工作。

And of course, as I've said repeatedly, it's hard to forecast ASP appreciation because you're like looking in the rearview mirror stuff. But we've done this before -- this team has done this before. And we feel really good about what we're putting in place to be best-in-class. And so we think we have upside opportunity there if we execute appropriately.

當然，正如我反覆說過的，很難預測 ASP 的升值，因為你就像在看後視鏡裡的東西一樣。但是我們以前做過這樣的事情——這個團隊以前做過這樣的事情。我們對於我們為成為一流企業所採取的措施感到非常高興。因此我們認為，只要我們執行得當，我們就有上行的機會。

Excellent. That's really helpful. And then just completely switching gears on KOAR, can you just remind us, I know you can't speak to the results obviously, but can you just remind us of the study objectives and maybe the end points that you were looking for or evaluating? I guess what I'm trying to get at is just, remind us why this is such an important study.

出色的。這真的很有幫助。然後完全轉換話題到 KOAR，您能否提醒我們一下，我知道您顯然不能談論結果，但您能否提醒我們研究目標以及您正在尋找或評估的終點？我想我要說的只是提醒我們為什麼這是一項如此重要的研究。

It's an important study because, as you know, Bill, with all of these products, the more evidence you build, the weight of the evidence becomes important. The size of the study, the number of patients enrolled, is it prospective, retrospective? Is there a control group? All these things are evaluated by payers.

這是一項重要的研究，因為比爾你也知道，對於所有這些產品，你建立的證據越多，證據的分量就越重要。研究的規模、入選患者的數量是前瞻性的還是回顧性的？有對照組嗎？所有這些都由付款人來評估。

And typically, when we launch these products, you see single center studies, no control groups, retrospective. And now we've got several multicenter studies, no control groups, relatively retrospective by and large.

通常，當我們推出這些產品時，你會看到單中心研究，沒有對照組，回顧性研究。現在我們已經進行了幾項多中心研究，沒有對照組，總體上是相對回顧性的。

And so KOAR is a prospective multicenter study of nearly 4,000 patients with a control group evaluating the efficacy of AlloSure Kidney to detect rejection ahead of other standard of care tools like serum creatinine, proteinuria, ultrasound, clinical signs and symptoms and really solidify that the use of the product is the best way to guide physician management of these patients, be it observation or biopsy, which has a much higher yield of rejection when you're managing the patient with AlloSure than without.

因此，KOAR 是一項前瞻性多中心研究，對近 4,000 名患者進行了對照組研究，評估了 AlloSure Kidney 在其他標準護理工具（如血清肌酸酐、蛋白尿、超聲波、臨床體徵和症狀）之前檢測排斥反應的功效，並真正鞏固了使用該產品是指導醫生管理這些患者的最佳方式，無論是觀察還是活檢

That's helpful. And if I can just ask one follow-up. Just as we think about the whole reimbursement situation and one of the issues being at least a perception maybe that initially, these tests were introduced to be done instead of biopsy, although I think we know in kidney, that doesn't make a ton of sense. But this study, this is not set up. I mean the comparison point is other clinical laboratory tests. The comparison point isn't biopsy. Is that accurate? Or is that not the case?

這很有幫助。我可以再問一個後續問題嗎？正如我們思考整個報銷情況一樣，其中一個問題至少是一種看法，也許最初這些測試是為了代替活檢而引入的，儘管我認為我們知道在腎臟方面，這並沒有多大意義。但這項研究，這並不成立。我的意思是比較點是其他臨床實驗室測試。比較點不是切片檢查。這樣準確嗎？或者事實並非如此？

Yeah, I mean, I think the intended use of AlloSure Kidney is to identify rejection in order to clinically manage patients. And so the goal of the study is not to avoid biopsies. The goal is to manage patients effectively such that when a biopsy is performed, the yield of rejection is much higher than in a patient who undergoes a biopsy that's not guided by AlloSure.

是的，我認為 AlloSure Kidney 的預期用途是識別排斥反應，以便對患者進行臨床管理。因此，這項研究的目標不是避免切片檢查。目標是有效地管理患者，使得進行活檢時排斥的發生率遠高於未接受 AlloSure 指導的活檢的患者。

Perfect. Okay, thank you very much.

完美的。好的，非常感謝。

Thank you.

謝謝。

Andrew Cooper, Raymond James.

安德魯庫柏、雷蒙詹姆斯。

Hey everybody, thanks for the question. Maybe just first starting a little bit on the P&L, Abhishek, I think you called out legal spend down really helping EBITDA. You don't back that out, looking at the run rate here in 4Q as a starting point, even if we adjust for some of the new hires and comp increases you get at the start of the year, why isn't that the right starting point? Why couldn't we see something higher than that [$29 plus million], guidance framework that you're laying out right now?

大家好，謝謝你們的提問。也許只是先從損益表開始，Abhishek，我認為您指出法律支出的減少確實有助於 EBITDA。你不會放棄這一點，將第四季度的運作率作為起點，即使我們根據年初的一些新員工和薪資成長進行調整，這為什麼不是正確的起點呢？為什麼我們沒有看到比您現在製定的指導框架（2900 多萬美元）更高的金額呢？

Yeah, no, that's a great question, Andrew. There are two pieces to this. Number one, on the adjusted EBITDA, the way I start to look at that we did $28 million in adjusted EBITDA in 2024. So I backed out the $70 million in revenue that basically we called out the revenue pertaining to the period prior to 2024.

是的，不，這是一個很好的問題，安德魯。這涉及兩部分。第一，關於調整後的 EBITDA，我開始認為我們在 2024 年的調整後 EBITDA 為 2800 萬美元。因此，我取消了 7000 萬美元的收入，基本上是 2024 年之前的收入。

So you adjust for that, you arrive at about $10 million in adjusted EBITDA and the midpoint of our adjusted EBITDA guidance for 2025, that's $31 million. So that $21 million drop on a $56 million increase in the revenue on a comparable basis, that's about like 37%, 38% of incremental margin drop to the bottom line.

因此，您對此進行調整，得出的調整後 EBITDA 約為 1000 萬美元，而 2025 年調整後 EBITDA 指引的中點是 3100 萬美元。因此，在可比較基礎上收入增加了 5,600 萬美元，而下降了 2,100 萬美元，這意味著利潤增量大約下降了 37% 到 38%。

And given the fact that we are making the investments to scale our operations, I believe that, that's a pretty good number to drive the adjusted EBITDA profitability, specifically to achieve our goal of $100 million in 2027.

考慮到我們正在進行投資以擴大營運規模，我相信，這是一個相當不錯的數字，可以推動調整後的 EBITDA 獲利能力，特別是實現我們 2027 年 1 億美元的目標。

And on your legal question part, the legal spend is already down in 2024. So that's not going to be impacting your 2025 because you've already seen the impact of that lower expense in 2024 itself, if that makes sense or maybe I'm missing anything otherwise.

關於您的法律問題部分，2024 年的法律支出已經下降。所以這不會對您的 2025 年產生影響，因為您已經在 2024 年看到了較低費用的影響，如果這說得通的話，或者也許我遺漏了其他什麼。

No, that's helpful. And then I know somebody already asked on surveillance trends. So I don't want to get into the nitty-gritty of where exactly are we right now. But when we think at a higher level and you think about some of the things you talk about in IOTA and updates to the procurement and utilization of organs and things like that, these should all be pointing people towards some of the reasons that AlloSure and -- or AlloMap are used.

不，這很有幫助。然後我知道有人已經詢問過監控趨勢。所以我不想深入討論我們目前的具體情況。但是，當我們從更高的層次思考時，想想你在 IOTA 中談論的一些事情以及器官採購和利用的更新等等，這些都應該向人們指出使用 AlloSure 和/或 AlloMap 的一些原因。

So when you think about the guide, when you think about the long term, how much of a lift can programs like that, can that focus really drive to drive that penetration from where it is in new patients today to something substantially higher. And I guess knowing that IOTA is, like you said, John, on a one-year basis why can't that happen a little bit faster?

因此，當您考慮指南並考慮長期時，這樣的計劃能夠帶來多大的提升，這種關注是否能夠真正推動滲透率從目前在新患者中的水平上升到更高的水平。而且我想，既然 IOTA 就像你說的一樣，以一年為基礎，為什麼不能快一點發生呢？

Yeah, I mean, we're pushing, Andrew. I don't disagree with you, and I think, any conversations that I've had, with the administration about this or our team has had with the administration is that yeah, they understand that these testing are important to monitor for patients, especially when you're asking centers to use more organs that are being allocated to them that they previously were turned down.

是的，我的意思是，我們正在努力，安德魯。我並不反對你的看法，我認為，我與管理層就此事進行過的任何對話，或者我們的團隊與管理層進行過的任何對話，都是這樣的，他們明白這些測試對於監測患者很重要，特別是當你要求中心使用更多分配給他們的器官（這些器官是他們之前拒絕的）時。

And that those patients are going to be at increased risk of rejection when those organs are utilized and so we think there's a huge role for our services, particularly in the context of the IOTA program and we're having active conversations across the country with transplant centers that are going to be a part of that program around everything from our digital tools, our HLA matching our new score, I'm sorry -- our new HLA matching software, to ensure that they have all the tools they need to manage those patients effectively and maintain high quality patient health outcomes post transplantation.

而這些患者在使用這些器官時，會出現更高的排斥風險，因此我們認為我們的服務發揮著巨大的作用，特別是在 IOTA 計劃的背景下，我們正在與全國各地的移植中心進行積極的對話，這些中心將成為該計劃的一部分，涉及我們的數位工具、我們的 HLA 匹配新評分，對不起——我們的新 HLA 並確保所有這些患者在所有的健康方面都保持健康結果，確保所有這些患者在所有 HLA 移植後都能保持健康的結果

Okay, helpful. And then maybe just one last one. I know Bill asked a little bit on ASP, but I just want to dig a little deeper on how you think about the ROI of, for example, the incremental heads. And I ask that with kind of in the back of my mind, if we back out the $2.2 million in 4Q, you're at about a little north of $1,350 from an ASP perspective.

好的，很有幫助。也許只剩最後一個了。我知道 Bill 問了一些關於 ASP 的問題，但我只是想更深入地了解您如何看待投資回報率 (ROI)，例如增量頭部。我在心裡想，如果我們在第四季拿出 220 萬美元，那麼從 ASP 的角度來看，您的價格大約會略高於 1,350 美元。

You should get some momentum with those incremental heads, hopefully. So when you think about that ROI, is this just an abundance of caution in the guidance? Or is there some other offset here to where from a mix perspective or something like that, we should think about that couple of dollars of lift as being a success?

希望您能從這些增量中獲得一些動力。那麼，當您考慮投資報酬率時，這是否只是指導中的謹慎之舉？或者從混合角度或類似角度來看，這裡是否存在其他的抵消因素，我們應該將那幾美元的提升視為成功？

Yeah, Andrew, so you're spot on there that if you were to back out the $2.2 million from the Q4 revenues, then the ASP would be roughly $1350 ish and we're looking at $1360 for the full year. So we're baking in what we have initially told that we are anticipating our ASPs to be growing in the low single digit and of course.

是的，安德魯，你說得對，如果從第四季度的收入中減去 220 萬美元，那麼 ASP 大約為 1,350 美元，而我們預計全年的平均售價為 1,360 美元。因此，我們正在考慮我們最初所說的，我們預計我們的 ASP 將以低個位數成長，當然。

As John kind of called out that as we're building this team as we bring in the new leader as well as we look for the system improvements on our RCM side, that basically stays an opportunity for us to grow. So we'll see as to how this pans out, but these are the numbers for now.

正如約翰所說的那樣，我們正在組建這個團隊，引入新的領導者，並尋求 RCM 方面的系統改進，這基本上為我們成長提供了機會。因此我們將觀察結果如何，但目前這些是數字。

Mason Carrico, Stephens.

梅森·卡里科，史蒂芬斯。

Could you update us on the number of protocols you have in place today? Any wins worth calling out year-to-date?

您能否向我們介紹一下目前已實施的協議數量？今年迄今有哪些值得稱道的勝利？

We didn't provide a protocol number, Mason. I think that's something that the organization did previously and then discontinued. And in Q3, we gave the number that we saw in that initial period post the reduction of the restrictive language in the LCD just to provide investors with some insight that this was starting to move in earnest.

我們沒有提供協議編號，梅森。我認為這是該組織以前做過但後來停止的事情。在第三季度，我們給出了在 LCD 中的限制性語言減少後的初始階段看到的數字，只是為了讓投資者了解這一點，即這開始認真採取行動。

Well, maybe if you could at least give us a little bit of insight into what you're seeing so far. I know you guys have talked about it taking a few quarters for these protocols to start pulling through surveillance volumes, but you also called out kidney outpacing other organs in the quarter.

好吧，也許您至少可以向我們介紹一下您目前所看到的情況。我知道你們已經談到這些協議需要幾個季度才能開始完成監測量，但你們也指出腎臟在本季度超過了其他器官。

So could you just give us a sense of how much of your surveillance volume that you're seeing today is coming from centers with protocols versus the broader market, just starting them to utilize them in that way? Are you seeing an increase in patient testing frequency at those centers, particularly the centers that were early to adopt a protocol versus your broader patient base?

那麼，您能否向我們介紹一下，您今天看到的監控量有多少來自有協議的中心，有多少來自更廣泛的市場，才剛開始以這種方式利用它們？您是否發現這些中心的患者檢測頻率增加，尤其是那些較早採用協議的中心，而您的患者群體更為廣泛？

Yeah, that's a great that's a great question, Mason. I'm happy to break that down. I think, yes, we are seeing movement, and it's very consistent with what I've previously described, which is that when a center does initiate a protocol, they're going to initiate that protocol on newly transplanted patients.

是的，這是一個很好的問題，梅森。我很高興能打破這個局面。我想，是的，我們看到了進展，而且與我之前描述的非常一致，即當一個中心確實啟動一個協議時，他們會對新移植的患者啟動該協議。

And thus, we're seeing a ramp-up in volume at those centers, consistent with the volume of transplants that they're performing on a monthly basis and then those patients transitioning from being incident transplant patients to prevalent patients on an ARTS protocol of 744.

因此，我們看到這些中心的移植數量不斷增加，與他們每月進行的移植數量一致，然後這些患者從偶然的移植患者轉變為 ARTS 方案下的常見患者，人數為 744 人。

In addition to that, we are -- and I appreciate your question here because I think it's sometimes missed and not understood well that the lack of a protocol does not mean that a center or a clinician does not use donor-derived cell-free DNA testing for surveillance purposes.

除此之外，我很感謝您在此提出的問題，因為我認為人們有時會忽略並且沒有很好地理解，缺乏協議並不意味著中心或臨床醫生不使用供體來源的無細胞 DNA 檢測進行監測目的。

So of our surveillance testing volume, some of it comes from centers with protocols and some of it comes from centers that don't have protocols, but individual clinicians that believe in the test and the impact that it has on patient outcomes because they've had that case where they've detected subclinical rejection using AlloSure, performed a biopsy, found that rejection and treated that patient effectively and we're able to save that graft. So there are believers like that all over the country that are managing patients with kidney transplants today, and we continue to work with those clinicians to make sure that their patients have high-quality outcomes.

因此，在我們的監測測試量中，有些來自有協議的中心，有些來自沒有協議的中心，但個別臨床醫生相信該測試及其對患者結果的影響，因為他們曾經遇到過這樣的案例，他們使用 AlloSure 檢測到了亞臨床排斥反應，進行了活檢，發現了排斥反應並對該患者進行了有效治療，我們能夠挽救移植物。因此，如今全國各地都有這樣的信徒在管理接受腎臟移植的患者，我們將繼續與這些臨床醫生合作，確保他們的患者獲得高品質的治療結果。

Got it thanks.

明白了，謝謝。

Eduardo Martinez, H.C. Wainwright.

愛德華多·馬丁內斯，H.C.溫賴特。

Good afternoon. This is Eduardo on for Yi Chen. A quick question. I guess you've talked about it already about the pharmacy management for the patients suffering from these drug-drug interactions with these immunosuppressants and trying to improve their adherence to some of these drugs. Do you have any more details about what strategies you're planning on implementing? Is it going to be like text reminders or whatever it may be? Just hoping to get some more color on the strategy there.

午安.這是 Eduardo，代表 Yi Chen 演出。一個簡單的問題。我想您已經討論過針對因這些免疫抑制劑而發生藥物交互作用的患者的藥房管理以及如何提高他們對某些藥物的依從性。您能否提供關於您計劃實施的策略的更多詳細資訊？它會像文字提醒一樣嗎或其他什麼？只是希望能夠獲得有關該戰略的更多詳細資訊。

Yes, thank you for the question, Eduardo, and for joining the call. Yes, we have digital tools where we do text-based medication reminders. We have a medication program that is used by many transplant centers where at the point of discharge, the clinician is able to download effectively like a PDF document that's specific to that patient, what their immunosuppression regimen is along with all the other medications they take, and it summarizes the drug-to-drug interaction so that the clinician can walk the patient through prior to discharge that information and then they're followed with a phone app, a consumer app that the patient utilizes that has reminders on using the medication. So that's our digital solution.

是的，謝謝你提問，愛德華多，也謝謝你參加這次電話會議。是的，我們有基於文字的數位工具來進行藥物提醒。我們有一個藥物計劃，許多移植中心都在使用，在患者出院時，臨床醫生能夠有效地下載特定於該患者的 PDF 文檔，其中包含患者的免疫抑制方案以及他們服用的所有其他藥物，並且總結了藥物之間的相互作用，以便臨床醫生可以在患者出院前指導患者了解這些信息，然後他們可以通過手機應用程序（患者使用的消費者應用程序）來提醒他們使用藥物。這就是我們的數位解決方案。

In addition to that, we have a specialty pharmacy that we operate as a business that delivers specialty therapeutics to patients that have undergone a transplant and the pharmacists at that specialty pharmacy, we're launching a more high-touch MTM program where the pharmacists interact directly with the patients and have that consultative discussion in a setting where perhaps the transplant center.

除此之外，我們還有一家專科藥房，為接受移植的患者提供專科治療，該專科藥房的藥劑師正在推出一項更高接觸的 MTM 計劃，藥劑師可以直接與患者互動，並在可能是移植中心的環境中進行諮詢討論。

The hospital or health system they're in, their pharmacists aren't really transplant specialists, and they're not trained to deal with those patients in a specific way. And so that clinician can refer -- he or she can refer their patients to the CareDx transplant pharmacy to be managed in a more high-touch way. And we see that today, particularly in higher-risk patients that perhaps don't have a good match or it was a compromised organ or maybe the patient has a concomitant health condition that complicates that medication drug-to-drug interaction issue.

他們所在的醫院或醫療系統及其藥劑師並不是真正的移植專家，而且他們也沒有接受過以特定方式處理這些患者的培訓。這樣，臨床醫生就可以將他們的病人轉診到 CareDx 移植藥房，以更高接觸的方式進行管理。我們今天看到這種情況，特別是在高風險患者中，可能沒有很好的匹配，或者器官受損，或者患者可能有伴隨的健康狀況，這使藥物之間的相互作用問題變得複雜化。

Great, that's really helpful. And then, pivoting more towards, you mentioned the one-year for the hematopoietic stem cell transplantation study. I'm curious what the time line is on that study and launch and what vision you guys have for that product?

太棒了，這真的很有幫助。然後，進一步來說，您提到了為期一年的造血幹細胞移植研究。我很好奇這項研究和發布的時間表是怎樣的，以及你們對該產品有什麼看法？

So it's a two-year follow-up study. And in February, at the Tandem cell therapy meeting, there was a one-year interim readout of data. And so there's another year of follow-up required in that study, but it is nearly fully enrolled. And so we anticipate talking about the launch of that product in upcoming calls as we get closer to the conclusion of that trial, the write-up of that data and its submission for Medicare coverage.

所以這是一項為期兩年的追蹤研究。今年 2 月，在串聯細胞治療會議上，進行了為期一年的中期數據讀取。因此研究還需要一年的跟踪，但研究對象基本上已全部入組。因此，隨著試驗的結束、數據的記錄和醫療保險覆蓋範圍的提交越來越接近，我們期待在接下來的電話會議中討論該產品的推出。

Great. And one final curiosity is as you guys are now thinking about capital allocation, and you mentioned about strategic partnerships, M&A opportunities. Do you have any thoughts on xenotransplantation or any interest in partnerships in that area?

偉大的。最後一個好奇的是，你們現在正在考慮資本配置，並提到了策略夥伴關係和併購機會。您對異種移植有什麼想法嗎？或對該領域的合作有興趣嗎？

CareDx has a number of partnerships in xenotransplantation. We have a product specifically for the monitoring of xeno grafts that has been utilized in nearly all of the xenotransplants that have occurred to date. So we have partnerships with each of the companies developing those modified organs and the transplant centers that are performing those procedures.

CareDx 在異種移植領域擁有多家合作夥伴。我們有一種專門用於監測異種移植的產品，該產品已用於迄今為止發生的幾乎所有異種移植手術。因此，我們與開發這些改良器官的每家公司以及執行這些程序的移植中心都建立了合作關係。

Okay, that's great, it's really helpful. That's all the questions for me thank you.

好的，太棒了，真的很有幫助。這就是我要問的所有問題，謝謝大家。

Thomas DeBourcy, at Nephron Research.

腎元研究機構的 Thomas DeBourcy 博士。

My question relates to your kidney data for this year in KOAR. And I was curious in terms of what that incremental data adds to your existing evidence base. I think it has real-world outcomes in it. And so is there a potential to drive greater protocol compliance and -- or drive additional payer wins as well?

我的問題與您今年在 KOAR 中的腎臟數據有關。我很好奇這些增量數據能為您現有的證據基礎增添什麼。我認為它會產生現實世界的成果。那麼是否有可能推動更大程度的協議合規性以及——或者推動更多付款人的勝利？

I think the answer is yes to both. There are many clinicians that are nonbelievers in donor-derived cell-free DNA testing and are waiting for more data to be published on these products before they adopt them. So like with any medical technology, there's an adoption curve that's a long cycle.

我認為答案都是肯定的。許多臨床醫生不相信捐贈者來源的無細胞 DNA 檢測，並在等待有關這些產品的更多數據發布後才採用它們。因此，與任何醫療技術一樣，其採用曲線有一個較長的周期。

And so continuing to publish well-designed large multicenter prospective trials is important both for clinician adoption and of course, for payer coverage, as I highlighted earlier. So we anticipate, as I described, the initial KOAR manuscript to be published in the second half of 2025. So I think that would really impact payer policies in 2026.

因此，正如我之前強調的那樣，繼續發表精心設計的大型多中心前瞻性試驗對於臨床醫生採用和付款人覆蓋都很重要。因此，正如我所描述的，我們預計初始 KOAR 手稿將於 2025 年下半年發布。所以我認為這將真正影響 2026 年的付款人政策。

Great thank you appreciate it.

非常感謝。

Thank you and gentlemen, it appears we have no further questions at this time, so that will bring us to the conclusion of today's call. Again, we'd like to thank you for joining CareDx's fourth quarter and fiscal year 2024 earnings conference call. Again, thanks so much for joining us. We wish you all a great remainder of your day. Goodbye, everyone.

謝謝各位，先生們，看來我們目前沒有其他問題了，今天的電話會議就到此結束。再次感謝您參加 CareDx 2024 財年第四季和 2024 財政年度收益電話會議。再次感謝您的加入。我們祝福大家今天餘下的時間過得很愉快。大家再見。