CareDx Inc (CDNA) 2025 Q1 法說會逐字稿

(Operator Instructions) Good day, everyone, and welcome to today's CareDx first quarter 2025 earnings conference call. (Operator Instructions) Please note this call may be recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Ms. Caroline Corner, Investor Relations. Please go ahead.

（操作員指示）大家好，歡迎參加今天的 CareDx 2025 年第一季財報電話會議。（操作員指示）請注意，此通話可能會被錄音，如果您需要任何協助，我將隨時待命。現在我很高興將會議交給投資人關係部的 Caroline Corner 女士。請繼續。

Thank you, Operator. Thank you for joining us today. Earlier today, CareDx released financial results for the first quarter of 2025, ending March 31, 2025. The release is currently available on the company's website at www.caredx.com. John Hanna, President and Chief Executive Officer; Robert Woodward, Chief Scientific Officer; and Abhishek Jain, Chief Financial Officer, will host this afternoon's call.

謝謝您，接線生。感謝您今天加入我們。今天早些時候，CareDx 發布了截至 2025 年 3 月 31 日的 2025 年第一季財務業績。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)；羅伯特伍德沃德 (Robert Woodward)，首席科學官；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 on this call that includes forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions 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上發表聲明，其中包括聯邦證券法所定義的前瞻性聲明，這些聲明是根據 1995 年《私人證券訴訟改革法》的安全港條款作出的。

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、有關承保決策的預期、定價和註冊事宜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, 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預期或暗示的結果有重大差異。因此，您不應過度依賴這些聲明。

For a list and description of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, April 30, 2025.

有關與我們的業務相關的風險和不確定性的清單和描述，請參閱我們向美國證券交易委員會提交的文件。本次電話會議中提供的資訊僅適用於今天（2025 年 4 月 30 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 不承擔任何更新或修改任何資訊、財務預測或其他前瞻性聲明的意圖或義務，除非法律要求，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. Reconciliations to the most directly comparable GAAP financial measures may be found in 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。在今天向美國證券交易委員會 (SEC) 提交的收益報告中，可以找到與最直接可比較的 GAAP 財務指標的對帳。

I will now turn the call over to John.

現在我將把電話轉給約翰。

Thank you, Caroline, and welcome to everyone joining today's call. We are broadcasting today live from Boston, Massachusetts, at the 45th Annual Meeting of the International Society of Heart and Lung Transplantation, where 60 abstracts, including 19 oral talks, were presented from data collected from over 90 transplant programs across the country on the use of CareDx Solutions.

謝謝你，卡羅琳，歡迎大家參加今天的電話會議。今天，我們正在馬薩諸塞州波士頓現場直播國際心肺移植學會第 45 屆年會，會上發表了 60 篇摘要，其中包括 19 篇口頭報告，這些摘要來自全國 90 多個移植項目收集的有關使用 CareDx Solutions 的數據。

To provide some context, there are approximately 170 health systems in the United States that have a heart or lung transplant program. That means novel data was presented this week on the use of CareDx products from approximately half of the heart and lung transplant centers in the United States. Later in the call, I will ask Robert Woodward, our Chief Scientific Officer, to share the highlights of several key abstracts.

具體來說，美國大約有 170 個醫療系統擁有心臟或肺移植計畫。這意味著本周美國大約一半的心肺移植中心公佈了有關 CareDx 產品使用情況的新數據。在稍後的電話會議中，我將請我們的首席科學官羅伯特·伍德沃德 (Robert Woodward) 分享幾個關鍵摘要的亮點。

We made good progress against our drivers of growth in the first quarter of 2025. It was our seventh consecutive quarter of sequential testing volume growth. Our testing services grew across all three organs: heart; kidney; and lung.

2025年第一季度，我們在成長動力方面取得了良好進展。這是我們連續第七個季度實現測試量成長。我們的檢測服務涵蓋所有三個器官：心臟；腎臟;和肺。

We launched two expanded indications for AlloSure, made progress with publications and continue to execute against our revenue cycle management and market access strategies. It has been a busy first quarter, and we are gaining momentum on delivering on our mission to create life-changing solutions that enable transplant patients to thrive.

我們推出了 AlloSure 的兩項擴展適應症，在出版方面取得了進展，並繼續執行我們的收入週期管理和市場准入策略。今年第一季非常忙碌，我們正在加緊努力，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。

I'll now dive into some of the first quarter performance and progress against our growth drivers. In the first quarter, we reported quarterly revenue of $84.7 million, up 18% year-over-year and a positive adjusted EBITDA gain of $4.6 million.

現在我將深入探討第一季的一些業績以及我們的成長動力的進展。第一季度，我們報告季度營收為 8,470 萬美元，年增 18%，調整後 EBITDA 收益為 460 萬美元。

Positioned to build upon that performance, we are reiterating our 2025 guidance of $365 million to $375 million in revenue, and an adjusted EBITDA gain of between $29 million and $33 million, and our long-range plan of achieving $500 million in revenue and 20% adjusted EBITDA in 2027. We ended the quarter with a strong cash balance of $231 million and no debt.

為了在此基礎上再創佳績，我們重申 2025 年營收目標為 3.65 億美元至 3.75 億美元，調整後 EBITDA 收益在 2900 萬美元至 3300 萬美元之間，以及我們的長期計劃，即在 2027 年實現 5 億美元的營收和 20% 的調整後 EBITDA 的調整。本季結束時，我們的現金餘額為 2.31 億美元，且沒有債務。

In Testing Services, revenue was $61.9 million for the quarter, up 15% year-over-year. We delivered Testing Services volume of approximately 47,100 tests in the first quarter, up 12% from the prior year. Daily testing volumes increased in February and March and have continued through April, led by AlloSure kidney surveillance testing growth.

測試服務本季營收為 6,190 萬美元，年增 15%。我們在第一季提供的測試服務量約為 47,100 次，比上年增長了 12%。2 月和 3 月的每日檢測量有所增加，這種趨勢一直持續到 4 月，其中 AlloSure 腎臟監測檢測的增長最為顯著。

Our increased sales footprint is having an impact, and I'm pleased with the progress we continue to make expanding kidney surveillance testing protocols. In March, we launched two expanded indications for AlloSure Testing. First, AlloSure Heart is now the only test validated and commercially available for pediatric heart transplant patients under age seven, including infants.

我們不斷擴大的銷售足跡正在產生影響，我對我們在擴大腎臟監測測試協議方面取得的進展感到高興。3 月份，我們推出了 AlloSure 檢測的兩項擴展適應症。首先，AlloSure Heart 是目前唯一經過驗證並可商業化應用於 7 歲以下兒童心臟移植患者（包括嬰兒）的測試。

Expanding the clinical indication of AlloSure for this population is important, because it allows us to service the entire market and shows our commitment to pediatric transplant programs. To frame this opportunity, over the past three years, there were approximately 500 heart transplants annually in patients under the age of 18.

擴大 AlloSure 針對這一人群的臨床適應症非常重要，因為它使我們能夠服務整個市場並表明我們對兒科移植計畫的承諾。為了抓住這個機會，過去三年來，每年約有 500 名 18 歲以下的患者接受心臟移植手術。

The second indication expansion is for AlloSure Kidney, which is now validated and commercially available for simultaneous pancreas-kidney transplant patients. Simultaneous pancreas-kidney transplants are primarily performed for patients with renal failure and insulin-dependent diabetes, and is a growing indication because it cures both diseases in a single procedure. In 2024, more than 700 patients received a simultaneous pancreas-kidney transplant.

第二個適應症擴展是針對 AlloSure Kidney，目前已被驗證並可供同時進行胰臟-腎臟移植的患者使用。同時進行胰臟-腎臟移植主要用於治療腎衰竭和胰島素依賴型糖尿病患者，由於手術可透過一次手術治癒兩種疾病，因此其應用範圍正在不斷擴大。2024年，超過700名患者接受了胰臟和腎臟同時移植。

We also made strong strides with payers this quarter, executing against our market access strategy of publishing evidence, expanding medical policy coverage and getting into payer networks. In the first quarter, we submitted the second manuscript from the SHORE study assessing the use of HeartCare in the management of over 2,700 heart transplant patients at 67 centers in the US.

本季度，我們在付款人方面也取得了長足進步，執行了發布證據、擴大醫療保險覆蓋範圍和進入付款人​​網路的市場准入策略。在第一季度，我們提交了 SHORE 研究的第二份手稿，該研究評估了 HeartCare 在美國 67 個中心對 2,700 多名心臟移植患者的管理中的使用情況。

As a reminder, we submitted the first manuscript from the KOAR study of over 3,600 kidney transplant patients from 56 transplant centers, and we anticipate these publications to contribute to HeartCare and AlloSure Kidney coverage in future quarters. In the first quarter, we added 3.5 million new covered lives for AlloMap Heart, and 15.5 million new covered lives for AlloSure testing. Early in the quarter, we were issued a new CPT code for AlloSure that became active for use on April 1, 2025.

提醒一下，我們提交了 KOAR 研究的第一份手稿，該研究涉及來自 56 個移植中心的 3,600 多名腎移植患者，我們預計這些出版物將在未來幾個季度為 HeartCare 和 AlloSure Kidney 的報導做出貢獻。第一季度，AlloMap Heart 新增受保人次 350 萬，AlloSure 檢測新增受保人次 1,550 萬。本季度初，我們獲得了 AlloSure 的新 CPT 代碼，該代碼於 2025 年 4 月 1 日生效。

And as a result, we converted six of our existing payer contracts to the new AlloSure specific code, and were able to obtain in-network status with a new large Blue Cross Blue Shield plan in the Southeast with over 3 million covered lives. We believe the combination of additional published evidence, coverage gains and in-network contracts will lead to ASP gains in future quarters.

結果，我們將六個現有的付款人合約轉換為新的 AlloSure 特定代碼，並能夠獲得東南部新的大型藍十字藍盾計劃的網絡內地位，該計劃覆蓋超過 300 萬人。我們相信，更多已發布的證據、覆蓋範圍的擴大以及網路內合約的結合將在未來幾季帶來平均售價的上漲。

I'd like to now turn it over to Robert Woodward to talk briefly about some of the important clinical evidence that was presented this week at the ISHLT Meeting in Boston. Robert?

現在我想請羅伯特·伍德沃德 (Robert Woodward) 簡要介紹本週在波士頓 ISHLT 會議上提出的一些重要臨床證據。羅伯特？

Thanks, John. As John shared, this year marks the 45th Annual Meeting of the International Society of Heart and Lung Transplantation, the largest scientific conference for cardiothoracic transplant each year. And CareDx products were featured in 60 abstracts, including 19 oral presentations, and at least 2 ISHLT symposia, in addition to our own Cardiac symposia.

謝謝，約翰。正如約翰所分享的，今年是國際心肺移植學會第45屆年會，這是每年規模最大的心胸移植科學會議。除了我們自己的心臟研討會之外，CareDx 產品還在 60 篇摘要中介紹，其中包括 19 篇口頭報告和至少 2 場 ISHLT 研討會。

As you may know, it is common for researchers to present the findings from studies at the Annual ISHLT Meeting in advance of writing up a full manuscript and submitting the findings for publication. Therefore, we view this large body of clinical abstracts as a strong sign of the future pipeline of journal publications to support both the growing clinical adoption and the payer coverage of our products.

您可能知道，研究人員通常會在撰寫完整的手稿並提交研究結果以供發表之前，在年度 ISHLT 會議上展示研究結果。因此，我們認為這大量的臨床摘要是未來期刊出版管道的強大訊號，以支持我們產品日益增長的臨床應用和付款人覆蓋。

Now let's explore some of the most significant data in both heart and lung. I will start with HeartCare, which includes both AlloMap gene expression profiling of immune activity, and AlloSure donor-derived cell-free DNA assessment of organ damage. New outcomes data from the SHORE study were showcased in 5 oral presentations out of a total of 8 abstracts accepted by the conference from this one study.

現在讓我們來探討一下心臟和肺部的一些最重要的數據。我將從 HeartCare 開始，它包括免疫活動的 AlloMap 基因表現分析和器官損傷的 AlloSure 供體來源的無細胞 DNA 評估。在會議接受的 8 篇 SHORE 研究摘要中，有 5 篇以口頭形式展示了研究的新結果資料。

First, Dr. Nir Uriel, a Principal Investigator on the SHORE study, and Professor of Medicine and Director of Heart Failure and Heart Transplant Programs at NewYork-Presbyterian/Columbia University, and Weill Cornell Medicine in New York, one of the largest heart transplant programs in the U.S., presented an oral abstract session -- at a session demonstrating that HeartCare may be more predictive of clinical outcomes than the histopathological evaluation of biopsy specimens.

首先，SHORE 研究首席研究員、紐約長老會/哥倫比亞大學醫學教授兼心臟衰竭和心臟移植計畫主任、紐約威爾康奈爾醫學院（美國最大的心臟移植計畫之一）的 Nir ​​Uriel 博士進行了口頭摘要陳述 —— 該陳述表明 HeartCare 可能比活檢標本的組織病理學評估更能預測臨床結果。

On slide 7, we provide some of the data. These data show that a dual-positive HeartCare result, indicating elevation of both immune activity and indicating organ damage was prognostic for poor outcomes, a composite outcome of graft dysfunction, rejection or death from rejection, even when the associated pathology review of biopsy was negative.

在第 7 張投影片上，我們提供了一些數據。這些數據表明，雙陽性 HeartCare 結果（表明免疫活動升高且表明器官受損）預示著不良結果，即移植功能障礙、排斥或因排斥而死亡的綜合結果，即使相關的活檢病理學檢查結果為陰性。

Nearly 25% of patients with dual-positive HeartCare and a negative biopsy readout had poor outcomes by 18 months post-transplant. These patients with dual-positive HeartCare and a negative pathology review were nearly 50% more likely to experience these negative outcomes such as death from rejection than patients without a dual-positive test. Importantly, HeartCare was prognostic of poor outcomes even when the pathology review of biopsy was negative.

近 25% 的患者在 HeartCare 檢測結果為陽性且活檢結果為陰性的情況下，移植後 18 個月內預後不佳。與未進行雙重陽性檢測的患者相比，這些 HeartCare 檢測結果為陽性且病理學檢查結果為陰性的患者發生排斥反應死亡等負面結果的可能性高出近 50%。重要的是，即使活檢病理檢查結果為陰性，HeartCare 也能預測不良結果。

These new data demonstrate that HeartCare may be more important -- a more important predictor of health outcomes in heart transplant patients than histology evaluation of a biopsy specimen. Second, in a presentation delivered by Dr. Jeffrey Teuteberg, Principal Investigator on the SHORE study, and a Professor of Medicine and Section Chief at Stanford University, it was shown that overall outcomes at centers using HeartCare were not associated with the number of biopsies performed at the center.

這些新數據表明，HeartCare 可能更為重要——比活檢標本的組織學評估更能預測心臟移植患者的健康結果。其次，SHORE 研究首席研究員、史丹佛大學醫學教授兼科長 Jeffrey Teuteberg 博士在一次報告中指出，使用 HeartCare 的中心的整體結果與該中心進行的活檢數量無關。

This presentation, some of which is shown on slide 8, was really eye-opening for the attendees and was a result of an extensive analysis of biopsy practices across 43 of the largest participating SHORE transplant centers. The results indicated that these centers performed biopsies at varying frequencies, ranging from less than one biopsy every 10 months to nearly 10 biopsies every 10 months in the first year.

這次簡報（部分內容展示在第 8 張投影片上）確實讓與會者大開眼界，它是對 43 個最大的 SHORE 移植中心的活檢實踐進行廣泛分析的結果。結果表明，這些中心進行活檢的頻率各不相同，從每 10 個月不到一次活檢到第一年每 10 個月近 10 次活檢不等。

Despite this variation, patient outcomes were not associated with the rate of biopsy, suggesting that the reducing biopsies in the context of using HeartCare has no negative impact on patient outcomes. Now turning to lung transplantation. We continue to see increasing adoption of AlloSure Lung across the country. Our observation in working closely with the physicians caring for these highly vulnerable patients is that the longitudinal use of AlloSure Lung is proving to be highly valuable.

儘管存在這種差異，但患者的治療結果與活檢率無關，這表明​​在使用 HeartCare 的情況下減少活檢次數不會對患者的治療結果產生負面影響。現在轉向肺移植。我們持續看到 AlloSure Lung 在全國範圍內的應用日益增多。我們與照顧這些高度脆弱患者的醫生密切合作，觀察到 AlloSure Lung 的長期使用被證明是非常有價值的。

Dr. Sam Weigt, Professor of Medicine and Director of Clinical Research for the Lung Transplant Program at UCLA, presented data from his institution during our Cardiac symposium. Dr. Weigt and his colleagues have focused on using personalized threshold for serial monitoring with AlloSure to better identify rejection.

加州大學洛杉磯分校醫學教授兼肺移植計畫臨床研究主任 Sam Weigt 博士在我們的心臟研討會上展示了來自其所在機構的數據。Weigt 博士和他的同事致力於使用個人化閾值對 AlloSure 進行連續監測，以更好地識別排斥反應。

By setting a personalized threshold based on a patient's AlloSure Lung longitudinal results over time, as demonstrated on slide 9, the sensitivity for detecting rejection improved over the use of a static threshold without an impact on specificity. The sensitivity improved from 50% to 75% in single lung transplant patients, and from 46% to 85% in bilateral lung transplant recipients.

透過根據患者的 AlloSure Lung 縱向結果隨時間推移設定個人化閾值（如投影片 9 所示），檢測排斥的敏感度比使用靜態閾值有所提高，且不影響特異性。對於單肺移植患者，敏感性從 50% 提高到 75%，對於雙肺移植接受者，敏感性從 46% 提高到 85%。

The approach by Dr. Weigt may lead the way in surveillance use of AlloSure Lung. These data complement those presented in a poster by the team at Tampa General Hospital, the institution with the largest number of total organ transplants in the United States last year. Their data, as described on slide 10, demonstrated similar utility for longitudinal assessment of AlloSure Lung. They analyzed the ability of AlloSure Lung to not only identify the onset of rejection, but also monitor treatment following the rejection event.

Weigt 博士的方法可能會引領 AlloSure Lung 的監測應用。這些數據是對坦帕綜合醫院團隊在海報上展示的數據的補充，坦帕綜合醫院是去年美國進行器官移植數量最多的機構。如投影片 10 所述，他們的數據證明了 AlloSure Lung 縱向評估具有類似的實用性。他們分析了 AlloSure Lung 不僅能辨識排斥反應發生的能力，還能監測排斥事件後的治療情況。

Their presentation showed a 50% increase of AlloSure Lung from a prior test to the test in which rejection was identified and a decrease back down to that same level following treatment. This year's ISHLT was the largest ever and was a remarkable event for CareDx. We now look forward to the continued generation of outcome data and publications with these centers, and the many others caring for transplant patients using CareDx Testing Solutions.

他們的報告顯示，與先前發現排斥反應的測試相比，AlloSure Lung 增加了 50%，而治療後又回落到同一水平。今年的 ISHLT 是有史以來規模最大的一次，對於 CareDx 來說是一個非凡的盛會。我們現在期待與這些中心以及許多其他使用 CareDx 測試解決方案照顧移植患者的中心繼續產生結果數據和出版物。

Now I'll turn it back to John.

現在我把話題轉回給約翰。

Thank you, Robert. It has been an exciting meeting, and we're looking forward to seeing some of these data begin to turn into manuscripts over the coming year. Before moving on from Testing Services, there are two additional topics I want to cover: our Testing Services pipeline development; and our efforts in operational excellence.

謝謝你，羅伯特。這是一次令人興奮的會議，我們期待在來年看到這些數據開始變成手稿。在繼續討論測試服務之前，我還想討論兩個其他主題：我們的測試服務管道開發；以及我們在卓越營運方面的努力。

First, this quarter, we presented data on our AlloHeme assay for hematologic malignancies at the Tandem Cell Therapy and Cell Transplant Conference in Hawaii, and the EMBT or European Bone Marrow Transplant Conference in Italy. This data included an interim 1-year readout of the two-year ACROBAT trial to monitor for minimal residual disease recurrence in patients with hematologic malignancies, that have undergone an allogeneic stem cell transplant.

首先，本季度，我們在夏威夷舉行的串聯細胞治療和細胞移植會議以及義大利舉行的歐洲骨髓移植會議 (EMBT) 上展示了針對血液系統惡性腫瘤的 AlloHeme 檢測數據。這些數據包括為期兩年的 ACROBAT 試驗的中期 1 年讀數，旨在監測接受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 from a cohort of 229 patients and 11 stem cell transplant centers in the U.S. demonstrate AlloHeme detects relapse a clinically meaningful time ahead of standard of care approaches. These data supporting AlloHeme will build the foundation for our Medicare coverage submission, following the completion of the ACROBAT trial in 2026.

這些來自美國 229 名患者和 11 個幹細胞移植中心的中期數據表明，AlloHeme 可以在標準治療方法之前提前、具有臨床意義的時間檢測到復發。這些支持 AlloHeme 的數據將為我們在 2026 年完成 ACROBAT 試驗後提交醫療保險覆蓋範圍奠定基礎。

To place a greater emphasis on organic expansion and execution of our product pipeline, we have added Jen Foley as Chief Product Officer. Jen brings over 20 years of commercial and product experience from Genentech in the fields of immunology, oncology, cardiology and neuroscience.

為了更加重視我們產品線的有機擴展和執行，我們任命 Jen Foley 為首席產品長。Jen 擁有 Genentech 在免疫學、腫瘤學、心臟病學和神經科學領域 20 多年的商業和產品經驗。

In her role, Jen will lead our product strategy, early market-shaping activities and product development efforts to expand into hematology. I look forward to providing further updates on our pipeline in future calls.

在她的職位上，Jen 將領導我們的產品策略、早期市場塑造活動和產品開發工作，以擴展到血液學領域。我期待在未來的電話會議中提供有關我們管道的進一步更新。

Lastly, in operational excellence, we are continuing to improve our enterprise infrastructure and business processes to operate more efficiently, such that revenue growth continues to outpace operational expenses as we scale. We are also announcing today that we have begun a significant initiative to integrate Epic Aura. We entered into this program with Epic, a leader in electronic health record software to utilize Epic Aura to make it easier for healthcare providers to order our Testing Services. It is our goal that by the end of the year, transplant centers using Epic's platform will be able to order AlloSure and AlloMap seamlessly through Epic Aura.

最後，在卓越營運方面，我們正在繼續改善我們的企業基礎設施和業務流程，以提高營運效率，以便隨著規模的擴大，收入成長繼續超過營運支出。我們今天也宣布，我們已經開始了一項整合 Epic Aura 的重要計劃。我們與電子健康記錄軟體領域的領導者 Epic 合作開展了這項計劃，利用 Epic Aura 讓醫療保健提供者更輕鬆地訂購我們的檢測服務。我們的目標是在今年年底，使用 Epic 平台的移植中心將能夠透過 Epic Aura 無縫訂購 AlloSure 和 AlloMap。

Now 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 $12 million in the first quarter, representing 24% year-over-year growth. Our go-to-market strategy is working, and we continue to see our patient and digital solutions unlocking growth opportunities for our Testing Services offerings.

現在轉向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。我們報告第一季的收入約為 1200 萬美元，年增 24%。我們的行銷策略正在發揮作用，我們繼續看到我們的患者和數位解決方案為我們的測試服務產品釋放成長機會。

On 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 U.S., we reported revenue of $10.8 million, representing 26% year-over-year growth.

實驗室產品業務收入達 1,080 萬美元，年增 26%，其中包括用於快速疾病供體 HLA 分型的 PCR 試劑盒、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。

Sales of our industry-leading AlloSeq Tx, next-generation HLA typing kits for organ recipients, continue to primarily drive this growth. In summary, we had a strong first quarter, executing across all of our key drivers, including go-to-market strategy, evidence generation and operational excellence.

我們業界領先的 AlloSeq Tx（用於器官接受者的下一代 HLA 分型試劑盒）的銷售繼續成為推動這一增長的主要動力。總而言之，我們第一季表現強勁，執行了所有關鍵驅動因素，包括市場進入策略、證據產生和卓越營運。

And now, I'll turn it over to Abhishek to share more details on our first quarter financial results. Abhishek?

現在，我將把時間交給 Abhishek，讓他分享有關我們第一季財務業績的更多細節。阿布舍克？

Thank you, John. In my remarks today, I will discuss our first quarter financial results before reiterating our 2025 guidance. Unless otherwise noted, my remarks will focus on non-GAAP results. For further information, please refer to GAAP to non-GAAP reconciliations in our press release, earnings presentation and recent SEC filings. Let me start with the key financial highlights from the quarter.

謝謝你，約翰。在今天的演講中，我將討論我們的第一季財務業績，然後重申我們的 2025 年指引。除非另有說明，我的評論將集中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 對帳。首先，我來介紹一下本季的主要財務亮點。

We reported total revenue of $84.7 million for the first quarter, up 18% year-over-year. We delivered approximately 47,100 test results in the first quarter, up 12% year-over-year. This performance reflects the seventh consecutive quarter of sequential Testing Services volume growth.

我們報告第一季總收入為 8,470 萬美元，年增 18%。我們在第一季提供了約 47,100 份測試結果，年增 12%。這項業績反映出測試服務量連續第七個季度成長。

Testing Services revenue was $61.9 million, up 15% year-over-year. Our adjusted Testing Services revenue was $63 million, up 26% year-over-year on a comparable basis, excluding $1.1 million in write-off for aged receivables.

測試服務收入為 6,190 萬美元，年增 15%。我們的調整後測試服務收入為 6,300 萬美元，年增 26%，不包括 110 萬美元的應收帳款註銷。

Patient and Digital Solutions revenue was $12 million, up 24% year-over-year, and product revenue was $10.8 million, up 26% year-over-year. We reported non-GAAP gross margin of 68.5%, up 150 basis points year-over-year. We expanded our gross margin across all businesses.

患者和數位解決方案收入為 1,200 萬美元，年增 24%，產品收入為 1,080 萬美元，年增 26%。我們報告的非公認會計準則毛利率為 68.5%，年增 150 個基點。我們擴大了所有業務的毛利率。

We reported an adjusted EBITDA gain of $4.6 million in the first quarter, compared to an adjusted EBITDA loss of $1.9 million in the first quarter of 2024. Finally, we ended the quarter with $231 million in cash, cash equivalents, and marketable securities, and no debt.

我們報告第一季調整後的 EBITDA 收益為 460 萬美元，而 2024 年第一季調整後的 EBITDA 虧損為 190 萬美元。最後，本季結束時我們擁有 2.31 億美元的現金、現金等價物和有價證券，並且沒有債務。

Moving to the details. Our non-GAAP Testing Services gross margin was 76.7% in the first quarter compared to 76.1% in the same quarter a year ago. The improvement in Testing Services gross margin was primarily driven by ASP expansion.

轉向細節。第一季度，我們的非公認會計準則測試服務毛利率為 76.7%，而去年同期為 76.1%。測試服務毛利率的增加主要得益於平均售價的擴張。

Our Patient and Digital Solutions non-GAAP gross margin for the quarter was 38.6% as compared to 34.3% in the first quarter of '24. Excluding our Transplant Pharmacy, which has a lower gross margin profile, our Patient and Digital Solutions non-GAAP gross margin for the first quarter was 67%, driven by a favorable mix of higher margin offerings.

本季我們的患者和數位解決方案非 GAAP 毛利率為 38.6%，而 24 年第一季為 34.3%。不計毛利率較低的移植藥房，第一季患者和數位解決方案非 GAAP 毛利率為 67%，這得益於高利潤產品的良好組合。

Our products non-GAAP gross margin for the first quarter was 54.3% as compared to 46.4% in the first quarter of '24. Improvement in gross margin was driven by better pricing and improved absorption of our manufacturing expenses associated with volume growth. Following the Administration's April 2 tariff announcement, we see no material impact on our business today. We operate mostly in the US, and have limited import of products in the U.S. that we manufacture in Europe. We anticipate less than $1 million annual impact to our Lab Products cost of goods.

我們產品第一季的非 GAAP 毛利率為 54.3%，而 24 年第一季為 46.4%。毛利率的提高得益於更好的定價和與銷售成長相關的製造費用吸收的改善。根據政府 4 月 2 日發布的關稅公告，我們認為這對我們今天的業務沒有實質影響。我們的業務主要在美國，美國祇有限度地進口我們在歐洲生產的產品。我們預計這對我們的實驗室產品成本每年的影響不到 100 萬美元。

Moving down the P&L. Non-GAAP operating expenses for the first quarter were $55.5 million compared with $52.3 million in the same quarter last year. The increase in operating expenses was driven by the investments in sales and marketing to accelerate growth, in line with our commercial go-to-market strategy. We continue to stay disciplined in managing our G&A and legal spend, which is down year-over-year.

降低損益。第一季非公認會計準則營運費用為 5,550 萬美元，而去年同期為 5,230 萬美元。營運費用的增加是由於對銷售和行銷的投資，以加速成長，這符合我們的商業市場進入策略。我們繼續嚴格管理一般及行政費用和法律支出，這些支出較去年同期有所下降。

I would also like to note that we have taken steps to reduce stock-based compensation expense as outlined in our 2025 proxy statement filed recently. We expect these actions, coupled with the expiration of agreements associated with former executives, will result in approximately 35% to 40% reduction in stock-based compensation expense for the full year 2025 over 2024.

我還想指出，我們已採取措施減少股票薪酬費用，如我們最近提交的 2025 年代理聲明中所述。我們預計，這些行動加上與前任高階主管相關的協議到期，將導致 2025 年全年的股票薪資支出將比 2024 年減少約 35% 至 40%。

We also have an update on the securities class action litigation. Last week, the company reached an agreement in principle to resolve the matter for $20.25 million. We anticipate that the company's D&O insurers will cover approximately $14.9 million of the total, leaving the company with out-of-pocket expense of approximately $5.4 million.

我們也公佈了證券集體訴訟的最新進展。上週，該公司原則上達成協議，以 2,025 萬美元解決此事。我們預計該公司的 D&O 保險公司將承擔總額中的約 1,490 萬美元，因此該公司的自付費用約為 540 萬美元。

We are now finalizing the definitive terms of the agreement, which will be subject to court approval. We look forward to putting this matter behind us. We reported an adjusted EBITDA gain of $4.6 million in the first quarter compared to an adjusted EBITDA loss of $1.9 million in the first quarter of '24.

我們目前正在敲定協議的最終條款，該條款需經法院批准。我們希望這件事能夠盡快過去。我們報告第一季調整後的 EBITDA 收益為 460 萬美元，而 24 年第一季調整後的 EBITDA 虧損為 190 萬美元。

The improvement in adjusted EBITDA was driven by revenue growth and operational leverage, which contributed to better gross margins and improved non-GAAP operating expenses as a percent of revenue. Our adjusted EBITDA margin expanded almost 800 basis points year-over-year.

調整後 EBITDA 的改善是由收入成長和營運槓桿推動的，這有助於提高毛利率並提高非 GAAP 營運費用佔收入的百分比。我們的調整後 EBITDA 利潤率年增近 800 個基點。

Turning to our cash balance. We ended the quarter in a strong position with cash, cash equivalents and marketable securities of $231 million and no debt, up $15 million as compared to $216 million at the end of Q1 2024.

談到我們的現金餘額。本季末，我們的現金、現金等價物和有價證券總額為 2.31 億美元，且無債務，較 2024 年第一季末的 2.16 億美元增加了 1,500 萬美元。

In the first quarter, we pay annual bonuses to our employees. Cash used in operating activities of $26.6 million in Q1 was driven by a reduction in accrued compensation of $24 million, primarily associated with annual bonus payout. We expect to generate cash from operating activities during the rest of the year and on a full year basis.

第一季度，我們發給員工年度獎金。第一季經營活動所用現金為 2,660 萬美元，主要是因為應計薪酬減少 2,400 萬美元，主要與年度獎金支付有關。我們預計今年剩餘時間和全年的經營活動將產生現金。

Turning to guidance. We are reiterating our revenue guidance of $365 million to $375 million in 2025. As we discussed in our last call, the midpoint of our '25 guidance assumes approximately 17% growth from our adjusted '24 revenue of $316 million. Our adjusted '24 revenue excludes the $17 million in revenue associated with tests performed in prior periods.

轉向指導。我們重申 2025 年 3.65 億至 3.75 億美元的營收預期。正如我們在上次電話會議上所討論的那樣，我們 25 年指引的中點假設我們調整後的 24 年收入 3.16 億美元將增長約 17%。我們調整後的 24 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 do a recap of the details on our '25 guidance.

讓我回顧一下我們 25 年指導的細節。

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. On testing volumes, sequential growth by quarter, we continue to expect 5% to 6% in the second quarter; 2% to 3% in the third quarter; and 5% to 6% in the fourth quarter of 2025. 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.

對於測試服務，我們預計測試量將比去年同期成長百分之十幾。我們估計，全年平均銷售價格約為每次測試 1,360 美元（混合計算）。就測試量而言，按季度連續成長，我們繼續預期第二季將成長 5% 至 6%；第三季為2%至3%；2025年第四季將成長5%至6%。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十五六個百分點。

We expect our non-GAAP gross margin to be approximately 70% and operating expenses to be approximately $235 million for the full year 2025. We expect our adjusted EBITDA gain for the full year '25 to be between $29 million and $33 million.

我們預計 2025 年全年非 GAAP 毛利率約為 70%，營運費用約為 2.35 億美元。我們預計 25 年全年調整後的 EBITDA 收益將在 2,900 萬美元至 3,300 萬美元之間。

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

說完這些，我現在將電話交給約翰來做最後的演講。

Thank you, Abhishek. In closing, I would like to thank all of the clinician partners that we have worked with, leading up to this year's ISHLT Meeting. At CareDx, we create life-changing solutions that allow transplant patients to thrive, but it is only in partnership with the clinicians that manage the care of transplant patients every day, that we can achieve our vision of a world where every patient receives the transplant they need to live longer, fuller lives.

謝謝你，阿布舍克。最後，我要感謝今年 ISHLT 會議召開前與我們合作過的所有臨床醫師夥伴。在 CareDx，我們創造改變生活的解決方案，讓移植患者能夠茁壯成長，但只有與每天管理移植患者護理的臨床醫生合作，我們才能實現我們的願景，即讓每個患者都能接受他們需要的移植，從而過上更長壽、更充實的生活。

And now, I'd like to ask the operator to open the line up to questions.

現在，我想請接線員打開熱線來回答問題。

(Operator Instructions) Matt Sykes, Goldman Sachs.

（操作員指示）高盛的馬特·賽克斯 (Matt Sykes)。

This is Will, on for Matt. Just starting higher level. You've talked about a gradual ramp in the return of surveillance volumes with it taking two or three quarters to turn protocols back on. Did you see signs of that volume starting to come back in the quarter? And I guess, more broadly, where are we at in that process?

我是威爾，取代馬特。剛開始更高層次。您談到了監控量恢復的逐步增加，需要兩到三個季度的時間才能重新啟用協議。您是否看到本季交易量開始回升的跡象？我想，更廣泛地說，我們在這個過程中處於什麼位置？

Yeah. Thanks for the question, Will. Absolutely, we are seeing signs of that volume coming back. We made progress on surveillance testing protocols in the fourth quarter and in the first quarter. And we see surveillance testing and kidney volumes really leading our growth across all organs.

是的。謝謝你的提問，威爾。毫無疑問，我們看到了交易量回升的跡象。我們在第四季和第一季的監測測試協議方面取得了進展。我們看到監測測試和腎臟數量確實引領著我們所有器官的成長。

Got it. That's super helpful. And then I guess, digging into the -- maybe the expenses for the quarter. R&D and SG&A were a little higher than we expected this quarter, but it sounds like a lot of that was compensation and investment in the sales and marketing team. How much of this is onetime? And how should we be thinking about the rate of spend throughout the rest of the year?

知道了。這非常有幫助。然後我想，深入研究一下——也許是本季的開支。本季研發和銷售、一般及行政費用略高於我們的預期，但聽起來其中很大一部分是銷售和行銷團隊的薪酬和投資。其中一次性的量是多少？那我們該如何考慮今年剩餘時間的支出率呢？

Yeah. The operating expenses, we have been keeping a very tight watch there. When I look at the operating expenses, they were up like 6% year-over-year. When you compare it with our revenue growth of 18%, that is actually providing us about 600 to 700 basis points improvements of the operating expenses as a percent of revenue. Now if you were to break it down between the 3 components, the R&D, S&M and G&A.

是的。我們一直密切關注營運費用。當我查看營運費用時，發現它們比去年同期增長了 6%。如果將其與我們 18% 的收入成長率進行比較，就會發現這實際上使我們的營運費用佔收入的百分比提高了約 600 到 700 個基點。現在，如果你將其分解為三個部分，即研發、銷售與市場和一般行政費用。

Our G&A expenses actually year-over-year is down on a non-GAAP basis. And you will see that the increase is primarily driven by the S&M, which is basically in line with our strategy where we have been investing in S&M to accelerate our growth. R&D expenses, I see that they are pretty flattish at about $17 million on a non-GAAP basis.

根據非公認會計準則，我們的一般及行政開支實際上同比有所下降。您會發現，成長主要由 S&M 推動，基本上符合我們一直投資 S&M 以加速成長的策略。我發現，以非 GAAP 計算，研發費用相當平穩，約 1,700 萬美元。

Mason Carrico, Stephens.

梅森·卡里科，史蒂芬斯。

So maybe to start, any additional color you're willing to share around surveillance volumes and the progress you've made on protocols? It looks like you called out that you expect it to have an impact in Q2. I know that's kind of on track. I think you guys may have been emphasizing back half more last quarter. So am I interpreting that right?

那麼首先，您願意分享有關監控量以及您在協議方面取得的進展的更多資訊嗎？看起來您已經表示預計它會在第二季產生影響。我知道這有點正確。我認為你們可能在上個季度更加強調這一點。那我的解釋正確嗎？

Is the benefit getting pulled forward a little bit? Or just any additional color around that comment?

福利是不是被提前了一點？或者只是對該評論進行一些額外的修飾？

Hi Mason, thanks so much for the question. Yeah, I don't think that we're suggesting pull forward. As you know, in last quarter's call, we signaled that we had anticipated some impact from weather and fires at the beginning of the quarter. And so we're just here emphasizing that we are making progress on surveillance testing. But given the slightly more muted Q1 volume, we're anticipating to see that growth in Q2.

你好，梅森，非常感謝你的提問。是的，我不認為我們建議向前推進。如您所知，在上個季度的電話會議中，我們表示我們預計本季初天氣和火災會造成一些影響。因此，我們在這裡強調我們在監測測試方面取得了進展。但考慮到第一季的交易量略微低迷，我們預計第二季將出現成長。

The centers have been responding very positively to the reinitiation of surveillance. And as I've been saying, we anticipate that as centers start on protocol again, they are going to initiate newly transplanted patients on those protocols, and that we'd see a gradual increase in the volume as they transplant patients month-over-month. And that has been playing out. That's what we're seeing in the field and in our numbers. And so I'm very pleased with the progress that we're making thus far, and I think we're right on pace with what we've guided for the year.

這些中心對重新開始監視做出了非常積極的反應。正如我一直所說的那樣，我們預計，隨著各中心重新開始執行協議，他們將按照這些協議開始接受新移植的患者，並且隨著他們逐月移植患者，我們會看到移植量逐漸增加。而這一切已經發生。這就是我們在實地和數據中看到的情況。因此，我對我們迄今為止的進展感到非常滿意，我認為我們的進度與我們今年的預期目標完全一致。

Got it. Okay. And John, it would be great to hear your latest thoughts around the MACs potentially issuing new LCDs for transplant testing? I mean, how are you thinking about the potential timing there, the impact? I mean, do you guys feel like you're in a much better position now if that were to play out given the amount of data that you guys have published over the last few years?

知道了。好的。約翰，我很想聽聽您對 MAC 可能為移植測試發放新的 LCD 的最新看法，對嗎？我的意思是，您如何看待那裡的潛在時機和影響？我的意思是，考慮到你們過去幾年發布的數據量，你們是否覺得現在的處境要好得多？

Absolutely, Mason. I think that the data has really grown in terms of the body of evidence supporting the benefit of surveillance testing in kidney. We had seen the agency put out their press release in August that the MACs may be issuing a new LCD to update that literature review and have that LCD become current with where the market is today, but we don't have any more indication as to the timing of that.

當然，梅森。我認為，支持腎臟監測檢測益處的證據數量確實在增加。我們看到該機構在 8 月發布的新聞稿中表示，MAC 可能會發布一份新的 LCD 來更新文獻綜述，並使 LCD 與當今的市場情況保持同步，但我們沒有更多關於其時間的跡象。

We've continued to push forward with the KOAR study, for example, and submitted that manuscript back in the fourth quarter, and we're looking forward to seeing that in print, and that should certainly contribute to solidifying the position that surveillance testing should be covered for these kidney transplant patients.

例如，我們繼續推進 KOAR 研究，並在第四季度提交了該手稿，我們期待看到其印刷版，這肯定有助於鞏固對這些腎移植患者進行監測測試的立場。

Tycho Peterson, Jefferies.

傑富瑞 (Jefferies) 的 Tycho Peterson。

This is Matt on for Tycho. Maybe first one -- congrats on the Epic launch. I think you had previously kind of talked about maybe launching that midyear. So is that a bit sooner than you had initially thought? And then are there any kind of onetime step-up in costs associated with the rollout of Epic?

這是 Matt 為 Tycho 所做的報道。也許是第一個——祝賀 Epic 的發布。我認為您之前曾談到可能在年中推出該產品。那麼這是否比您最初想像的要早一點？那麼，Epic 的推出是否會導致成本的一次性增加？

And then just, John, on the other side of that rollout, which sounds like it could be by the end of the year, can you just talk about kind of the friction removed for those centers and what you could theoretically expect to see from a volume impact on the other side once fully rolled out?

然後，約翰，在推出的另一邊，聽起來可能會在今年年底之前，您能否談談這些中心消除的摩擦，以及一旦完全推出，理論上您可以預期在另一邊看到什麼樣的數量影響？

Yeah. I'm going to ask Keith to take that one.

是的。我要請基斯 (Keith) 來接手這個。

We're really excited about Epic. We have 20 people up there right now for their user conference, which is going really well. I think we're one of the largest attendees. I got some pictures that they had our name up there on the big screen. So it was really exciting.

我們對 Epic 感到非常興奮。我們現在有 20 個人參加他們的用戶會議，進展非常順利。我認為我們是最大的與會者之一。我拍了一些照片，大螢幕上顯示了我們的名字。所以這真的很令人興奮。

We've been talking about this with customers here at the conference, and they're very excited about that. We took over the Epic environment in early April. We will have that fully launched, and essentially the setup that we will deploy with customers by the end of the second quarter.

我們在會議上與客戶討論過這個問題，他們對此感到非常興奮。我們在四月初接管了 Epic 環境。我們將全面啟動這項計劃，並在第二季末與客戶一起部署此設定。

And then we will starting July 1 work on the first pilot launches. So you select a group of customers that will work with you to launch this, work out the kinks, and then you go out and you broadly launch that, which we will do starting in the fourth quarter.

然後我們將從 7 月 1 日開始進行首次試點發射。因此，您可以選擇一組客戶與您合作推出產品，解決問題，然後您再廣泛地推出產品，我們將從第四季度開始這樣做。

And people are very, very excited about that. We have a couple of tricks up our sleeves we're not going to disclose right now, but we're working on a couple of other things to really make this impactful, so that we're building our way into '26 and '27 with clients. But I think generally, the response is really good. And I think we're -- Epic told us we're a couple of months ahead of anybody else who's ever done this. So we're really working hard at it.

人們對此感到非常非常興奮。我們還有一些秘訣，現在不會透露，但我們正在研究其他一些事情，以真正發揮影響力，這樣我們就能與客戶一起邁入 26 年和 27 年。但我認為整體而言，反應非常好。我認為——Epic 告訴我們，我們比其他做過這件事的人領先了幾個月。所以我們確實在努力工作。

It's good to hear. And then --?

聽到這個消息真好。進而--？

And on the cost side, just so you know, this is about a $5 million investment every year for any diagnostics company. And then they have a per click, per test fee that gets added in there. But in the end, I think Epic would make the argument, everybody else made the argument that over time, just pays for itself.

而在成本方面，對於任何診斷公司來說，這都是每年約 500 萬美元的投資。然後他們會在其中添加每次點擊、每次測試的費用。但最終，我認為 Epic 會提出這樣的論點，其他人也會提出這樣的論點，隨著時間的推移，它就能收回成本。

And then, John, appreciate the color, just in terms of the two new product launches, and the opportunity in terms of existing volumes for each one of those. Can you just kind of help us better understand a realistic penetration for both of those in, call it, year 1 and 2025? I mean, is it a few percentage points to what you talked about? Or could it be something more meaningful kind of in the double-digits? Just how do we think about the launches into the 2 kind of indications you described, and what realistic penetration could be in the, call it, near term in 2025?

然後，約翰，就兩款新產品的發布而言，我很欣賞它的色彩，以及每個新產品現有銷售的機會。您能否幫助我們更了解第一年和 2025 年這兩者的實際滲透率？我的意思是，這和你所說的話相比有幾個百分點嗎？或者它可能是兩位數中更有意義的數字？我們該如何看待您所描述的兩種跡象的發布，以及在 2025 年的短期內，實際滲透率能達到什麼程度？

Yeah, thanks so much for the question. I think realistically, penetration could be relatively high in those 2 indications. As I shared, the total volume of procedures is not huge, but they are significant procedures and ones where the clinical scenario is just slightly different from the core adult solid organ transplant validation of the testing. And so we felt like it was really important, given the increasing volume in simultaneous pancreas-kidney, and the really, really significant medical need in adolescent heart transplant to get the products validated for those indications, so that we can deliver to those clinicians a validated report and give them confidence in using the testing for those populations.

是的，非常感謝您的提問。我認為，從現實角度來看，這兩個適應症的滲透率可能相對較高。正如我所分享的，這些程序的總量並不大，但它們都是重要的程序，臨床情況與核心成人實體器官移植驗證測試略有不同。因此，考慮到同時進行的胰臟腎臟移植的數量不斷增加，以及青少年心臟移植的真正重大的醫療需求，我們認為對產品進行這些適應症的驗證非常重要，以便我們可以向這些臨床醫生提供經過驗證的報告，並讓他們有信心對這些人群進行測試。

Mark Massaro, BTIG.

BTIG 的馬克馬薩羅。

This is Vivian on for Mark. So I think in the past, you've discussed improvements in billing and collections as a key lever in driving ASPs. I know you touched on Epic integration earlier. Is there just anything else around maybe sales force incentivization or just any other variables to call out that could further drive ASPs here?

我是薇薇安，代替馬克。所以我認為，過去您曾討論過改進計費和收款作為推動 ASP 的關鍵槓桿。我知道您之前提到過 Epic 整合。是否還有其他因素，例如銷售人員激勵措施或其他變量，可以進一步推動平均售價？

Yeah. Thanks, Vivian. I'll let Keith talk to that.

是的。謝謝，薇薇安。我會讓基斯談論這個。

Hey Vivian, it's Keith. As you know, we just made a large investment in the leadership team and the revenue cycle management team, as well as the rest of the staff. We just came off a really productive off-site where we're reengineering all the workflows associated with revenue cycle management. And so that's been very productive, and I expect long-term benefits of that. So we made the decision to focus in on the near term, getting the claims filed, clean claims, doing eligibility verification on 100% of our patients, improving our authorization success rate, and establishing an appeals team and process to dramatically drive ASP.

嘿，薇薇安，我是基斯。如您所知，我們剛剛對領導團隊、收入週期管理團隊以及其他員工進行了大量投資。我們剛結束了一次非常有效率的場外活動，在那裡我們正在重新設計與收入週期管理相關的所有工作流程。因此，這是非常有成效的，我期望它能帶來長期利益。因此，我們決定將重點放在短期內，提交索賠、清理索賠、對 100％ 的患者進行資格驗證、提高授權成功率，並建立上訴團隊和流程以大幅推動 ASP。

I think these improvements will take effect over 6 to 8 quarters. So you're not going to just turn on a workflow and 10 days later there's a major impact. But I think what we're trying to do is drive significant increase. And the way to do that is to get those claims in on time and clean claims. And then I would turn to the market access side.

我認為這些改進將在 6 到 8 個季度內生效。因此，您不可能只是啟動一個工作流程，10 天後就會產生重大影響。但我認為我們正在努力推動的是大幅成長。而實現這一目標的方法就是及時提出索賠並清理索賠。然後我想談談市場准入方面。

And on that, I'd say we're focusing on the coverage and contracting with key payers, including the VA as well as the Medicaid states. Driving -- second would be driving payer adoption using our AlloSure PLA code that John referenced. The third would be systematically reducing the number of required prior authorizations. So as you know, on Medicare Advantage, they can require prior authorizations. It's really important that you manage that process.

就此而言，我想說，我們將重點放在保險範圍以及與主要付款人的簽約，包括退伍軍人事務部和醫療補助州。推動——第二是使用約翰提到的 AlloSure PLA 代碼來推動付款人的採用。第三是系統性地減少所需的事先授權的數量。因此，如您所知，對於醫療保險優勢計劃，他們可以要求事先授權。管理該過程確實非常重要。

And then the fourth was what Robert talked about is using newly published clinical data to drive medical policy reviews and guideline updates. That would be my summary of how to address that, Vivian.

第四個是羅伯特談到的利用新發布的臨床數據來推動醫療政策審查和指南更新。這就是我對如何解決這個問題的總結，薇薇安。

Yeah, that was great color. And then I just had two quick cleanups on the model. Just the first one was other labs in our space have called out severe weather impacts. I don't think I heard anything on that front. And then just the second part was prior period collections in the quarter, if you could touch on those two?

是的，顏色很棒。然後我對模型進行了兩次快速清理。第一個是我們領域的其他實驗室已經注意到了嚴重的天氣影響。我認為我沒有聽到有關這方面的任何消息。第二部分是本季的前期收款，您能談談這兩個面向嗎？

So on the first one, when we talk about the impact of the weather on our Testing Services volumes for the Q1, we believe that it impacted about 500 to 600 tests for the quarter or about a point of the growth there. And on your second question regarding the collection adjustments, we have called out $1.1 million that we basically take as a write-off due to the aged receivables. So probably you -- and that's what I've called out in the adjusted revenue for the Testing Services, where the revenue for Testing Services was $63 million on an adjusted basis.

因此，關於第一個問題，當我們談論天氣對第一季測試服務量的影響時，我們認為它影響了本季約 500 到 600 次測試，或影響了該季度的成長點。關於您關於收款調整的第二個問題，我們已經指出了 110 萬美元，基本上是因應收帳款過帳而註銷的。所以可能你——這就是我在測試服務調整後的收入中所提到的，測試服務的收入在調整後的基礎上為 6300 萬美元。

And I'd point out that, that is over probably three to four quarters of revenue. So you're talking over a $1.1 million adjustment on over $300 million in revenue.

我想指出的是，這可能超過了三到四個季度的收入。所以您說的是，在超過 3 億美元的收入中，有 110 萬美元的調整。

Yeah.

是的。

So it's essentially a minor cleanup of the ARs we have sort of.

所以這本質上是對我們現有的 AR 的小規模清理。

Brandon Couillard, Wells Fargo.

布蘭登‧庫亞爾 (Brandon Couillard)，富國銀行。

John, the UNOS procedure data is pretty muted year-to-date, kind of only up low singles. What's embedded in the guidance as far as kind of overall procedure volumes? And does that need to pick up for you to hit the high end of the range?

約翰，今年迄今為止，UNOS 程式數據相當低迷，只有低位單打。就整體程序量而言，指南中包含哪些內容？您是否需要提高這個數值才能達到高端水準？

Thanks Brandon. Appreciate the question. We feel like we're on track with our guidance. Our business, as I said in the prepared remarks, performed really strong in February and March, and that continued into April, despite the softer start to the year on transplant procedures, as you pointed out in the UNOS data. We also believe that there's the potential to see a significant uptick in procedures in the second half of the year as the IOTA Program initiates July 1, 2025.

謝謝布蘭登。感謝你的提問。我們感覺我們的指導正在順利進行中。正如我在準備好的發言中所說，我們的業務在 2 月和 3 月表現非常強勁，並且這種勢頭一直持續到 4 月，儘管今年的移植手術開局較為疲軟，正如您在 UNOS 數據中指出的那樣。我們也相信，隨著 IOTA 計畫於 2025 年 7 月 1 日啟動，下半年的程序有可能會顯著上升。

So we provided in our long-range guide an expectation of 5% overall growth of the market on a compounded annual basis, which is consistent with historic trends. And that number tends to go up and down every year by a couple of hundred basis points. And so we feel like we're still in a great position on the guide, and we're not really concerned about the transplant volumes right now.

因此，我們在長期指南中預期市場整體年複合成長率為 5%，這與歷史趨勢一致。而且這個數字每年都會上下波動幾百個基點。因此，我們覺得我們仍然處於指南的良好位置，並且我們現在並不真正擔心移植量。

Okay. Then on the new CPT code, John or AJ, could you just walk through the impact of that, and how it leads to greater in-network coverage, and I guess, ultimately a higher ASP per test?

好的。那麼，關於新的 CPT 程式碼，John 或 AJ，您能否簡單介紹一下它的影響，以及它如何帶來更大的網路覆蓋範圍，以及我猜，最終如何帶來更高的每次測試的 ASP？

Yeah, that's a great question. Typically, just because you have a code doesn't mean you get paid more. But in our case, because we have substantial evidence supporting AlloSure, and we have been gaining private payer coverage over the past several years, what we've seen is that the absence of having a test-specific code has inhibited our ability to get payer contracts and get in-network for that service.

是的，這是一個很好的問題。通常，僅僅因為您有程式碼並不意味著您會獲得更多報酬。但在我們的案例中，由於我們有大量證據支持 AlloSure，並且在過去幾年中我們一直在獲得私人付款人的承保，我們發現，缺乏特定於測試的代碼阻礙了我們獲得付款人合約和進入該服務網絡的能力。

And so we decided to pursue the AlloSure specific code, which we can use for heart, kidney, and lung, because it's agnostic to organ, to contract with third-party payers, like the Blue Cross plan that I described in the prepared remarks, and get in the network which allows us to get paid on a first pass claim, and get paid that contracted rate versus the claim being denied, because we're billing an unlisted code, and then go through the whole appeal process.

因此，我們決定採用 AlloSure 特定代碼，該代碼可用於心臟、腎臟和肺部，因為它與器官無關，與第三方付款人簽訂合同，例如我在準備好的評論中描述的藍十字計劃，並加入網絡，這使我們能夠在首次通過索賠時獲得付款，並且按照合同費率獲得付款，而不是上訴被拒絕，因為我們正在對未列出的代碼進行計費。

And it takes many, many, many months to collect the cash. So we're really optimistic about the impact the code can have, given that we think we can convert some of these coverage policies into contracts here in the near term.

而且要花很多很多個月的時間才能收取現金。因此，我們對該法規可能產生的影響非常樂觀，因為我們認為我們可以在短期內將其中一些覆蓋政策轉化為合約。

Thomas DeBourcy, Nephron Research.

德布爾西 (Thomas DeBourcy)，腎元研究。

Just first question was on Transplant Pharmacy. You mentioned seeing an incremental benefit from the Transplant Pharmacy on Testing Services revenue. So just wanted to get some more color in terms of how you're seeing that play out in practice with patients?

第一個問題是關於移植藥局的。您提到移植藥局的檢測服務收入帶來了增量效益。那麼，您只是想進一步了解您在實踐中對患者是如何看待這一現象的？

I think the way to think about that is, as we laid out in our Investor Day last October, we believe that the synergy between our Patient and Digital Solutions and our Testing Services business is very strong. And as we sell solutions into the transplant centers, such as our software products, our pharmacy offering, it gives us the opportunity to unlock more growth in our Testing Services business, whether that be capturing more patients that are transplanted on the center onto a testing protocol or ensuring those patients for which Testing Services is ordered on the protocol that they adhere to that protocol.

我認為思考這個問題的方式是，正如我們在去年 10 月的投資者日所述，我們相信我們的患者和數位解決方案與我們的測試服務業務之間的協同作用非常強。當我們向移植中心銷售解決方案（例如我們的軟體產品、藥品產品）時，它使我們有機會在檢測服務業務中實現更多成長，無論是讓更多在中心移植的患者加入檢測方案，還是確保那些根據方案訂購檢測服務的患者遵守該方案。

And so we're seeing that our Patient and Digital Solutions, it's not that it's giving a revenue benefit. It's really giving us greater access and deeper engagement with the customers to help convert into more, for example, AlloSure Kidney protocol adoption across these centers.

因此，我們看到我們的患者和數位解決方案並沒有帶來收入效益。它確實讓我們能夠更廣泛地接觸客戶，並與客戶進行更深入的互動，從而幫助這些中心採用更多的產品，例如 AlloSure 腎臟協議。

Understood. And just as a follow-up, on the IOTA Program, you had mentioned last quarter software to automatically, I guess, track quality scores for transplant centers. And I was just curious the feedback that you're getting from centers of that solution?

明白了。作為後續問題，關於 IOTA 計劃，您上個季度提到了可以自動追蹤移植中心品質評分的軟體。我只是好奇您從該解決方案中心獲得了什麼回饋？

Yeah. We're getting a lot of positive feedback on that. Thanks for the question. We've been on a bit of a roadshow, talking with the centers that have been selected for the IOTA Program because that's a public list. And our team that manages our quality reporting software tool has been going center to center, having discussions with them about preparation for the initiation of the program, and the enhancements that we're making to the software that enabled them to report.

是的。我們對此收到了很多正面的回饋。謝謝你的提問。我們一直在進行路演，與被選中參與 IOTA 計劃的中心進行交談，因為這是一個公開名單。我們管理品質報告軟體工具的團隊一直在與他們進行中心討論，了解啟動該計劃的準備工作，以及我們對使他們能夠報告的軟體所做的增強。

The reporting process for IOTA is on an annual basis. So they don't have to start reporting on July 1, 2025. In fact, they won't have to report until June 26. So really, for us right now, it's education on the capability set that, that software tool is going to have so that it enables them to track their progress throughout that first-year cycle and then be prepared to report when that first-year cycle ends.

IOTA 的報告流程是每年一次。所以他們不必從 2025 年 7 月 1 日開始報告。事實上，他們直到 6 月 26 日才需要報告。因此，對我們來說，現在實際上就是對該軟體工具所具備的功能進行教育，以便他們能夠在整個第一年​​周期內追蹤他們的進度，然後準備在第一年周期結束時進行報告。

(Operator Instructions) Yi Chen, H.C. Wainwright.

(操作員指示) Yi Chen, H.C.溫賴特。

This is Eduardo on for Yi. Just a quick question about kind of competitive developments in the space, specifically OncoCyte and VitaGraft, and their recent announcement for Medicare expansion. Do you envision that having impact -- any impact on your guys' guidance? Or do you guys consider your technology to be kind of far better and superior?

愛德華多替補易建聯上場。我只是想問一個簡單的問題，關於該領域的競爭發展，特別是 OncoCyte 和 VitaGraft，以及他們最近宣布的醫療保險擴展。您是否認為這會對您們的指導產生影響？還是你們認為你們的技術更優秀、更先進？

I think I read the OncoCyte announcement this morning stating that they were going to initiate a study to try to get approval for their product, but that it's several years away. So I don't anticipate that having any impact on our guidance. And quite frankly, as you know, we're the market leader in this segment in transplant, and we've been in this market for nearly 25 years.

我想我今天早上讀過 OncoCyte 的公告，說他們將啟動一項研究以爭取其產品的批准，但這還需要幾年的時間。所以我預計這不會對我們的指導產生任何影響。坦白說，正如您所知，我們是移植領域的市場領導者，我們已經在這個市場上經營了近 25 年。

So more than half of the life of the ISHLT program CareDx has been participating in this conference and with this community. And while I think competition is always good for patients and for clinicians in the market and for innovation, I don't see one entity like OncoCyte really having an impact on how we guide the year.

因此，ISHLT 計劃 CareDx 的一半以上時間都在參與這次會議並與這個社區合作。雖然我認為競爭對於患者、市場中的臨床醫生以及創新總是有益的，但我並不認為像 OncoCyte 這樣的實體能夠真正影響我們今年的指導方針。

Okay. Yeah. I mean I was familiar with the GraftAssure, which is the digital PCR. That one is still in development. VitaGraft, I understand had regulatory approval, and they were looking to get Medicare expansion.

好的。是的。我的意思是我熟悉 GraftAssure，即數位 PCR。那個仍在開發中。據我了解，VitaGraft 已獲得監管部門的批准，他們正在尋求擴大醫療保險範圍。

Yeah, it's not something I'm familiar with, Eduardo, but we'll look into it.

是的，愛德華多，這不是我熟悉的東西，但我們會研究它。

With no further questions at this time, that will conclude today's CareDx first quarter 2025 earnings conference call. We would like to thank you all for your participation. You may disconnect at any time.

目前沒有其他問題，今天的 CareDx 2025 年第一季財報電話會議就此結束。我們感謝大家的參與。您可以隨時斷開連線。