CareDx Inc (CDNA) 2024 Q3 法說會逐字稿

(Operator Instructions)

（操作員指令）

Good day, everyone and welcome to today's CareDx Inc third quarter, 2024 earnings conference call.

大家好，歡迎參加今天的 CareDx Inc 2024 年第三季財報電話會議。

At this time. All participants are in a listen-only mode later. You will have the opportunity to ask questions during the question-and-answer session.

此時。所有參與者稍後都會處於只聽模式。您將有機會在問答環節提出問題。

Please note today's call will be recorded and I will be standing by. Should you need any assistance? It is now my pleasure to turn the conference over to Greg Chodaczek Managing Director. Please go ahead, sir.

請注意，今天的通話將被錄音，我將隨時待命。您需要任何協助嗎？現在我很高興將會議交給董事總經理 Greg Chodaczek。先生，請繼續。

Thank you, Chloe and good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the quarter ending September 30, 2024.

謝謝你，克洛伊，下午好。感謝您今天加入我們。今天早些時候，CareDx 發布了截至 2024 年 9 月 30 日的季度財務表現。

The release is currently available on the company's website at www. caredx.com. John W. Hanna, President and Chief Executive Officer and Abhishek Jain Chief Financial Officer will host this afternoon's call.

新聞稿目前可在該公司網站 www. 上查閱。 caredx.com。總裁兼執行長 John W. Hanna 和財務長 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 that include 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中發表聲明，其中包括根據 1995 年私人證券訴訟改革法的安全港規定做出的聯邦證券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 of 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運營趨勢的審查、對承保決策的預期、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 for a list and descriptions of the risks and uncertainties associated with our business. Please see our filings with the Security and Exchange Commission.

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。您不應過度依賴這些聲明來了解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。

The information provided in this conference call speaks only to the live broadcast today, November 4, 2024 CareDx disclaims any intention or obligation except required by law to update or revise any information, financial projections or other forward-looking statements. Whether because of new information, future events or otherwise.

本次電話會議中提供的資訊僅針對今天（2024 年 11 月 4 日）的現場直播，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聲明。無論是因為新資訊、未來事件或其他原因。

This call will also include a discussion of certain certain financial measures that are not calculated in accordance with generally accepted accounting principles.

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。

Reconciliation to the most direct comparable GAAP Financial measure may be found in today's earnings release filed with the SEC. I will now turn the call over to John.

在今天向美國證券交易委員會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。現在我將電話轉給約翰。

Thank you, Greg, and thank you to all who are listening to today's call.

謝謝你，格雷格，也謝謝所有聆聽今天電話會議的人。

CareDx had another strong quarter with year over year growth across our business.

CareDx 又度過了一個強勁的季度，業務較去年同期成長。

We reported revenue of 82.9 million, representing 23% year over year growth. We expanded our gross margins and managed our expenses well, leading to positive adjusted EBITDA 6.9 million above our guide of being EBITDA neutral.

我們報告的收入為 8,290 萬美元，年增 23%。我們擴大了毛利率並很好地管理了費用，導致調整後的 EBITDA 為正 690 萬美元，高於我們預期的 EBITDA 中性水準。

We generated 12.5 million in cash from operations and ended the quarter with a strong balance sheet of 241 million in cash and cash equivalents and no debt.

我們從營運活動中產生了 1,250 萬美元的現金，並在本季結束時擁有 2.41 億美元的現金和現金等價物且沒有債務的強勁資產負債表。

We believe CareDx has turned the corner toward long term profitable growth in my prepared remarks. I will provide commentary on Q3 and insight into Q4 and our revised guidance.

正如我之前所準備的演講中所說，我們相信 CareDx 已經邁向長期獲利成長。我將對第三季的評論以及對第四季度和我們修訂後的指引的見解。

Then I will turn the call over to Abhishek who will review our finances and guidance assumptions in further detail in testing services. We delivered approximately 44,600 tests up 16% from the prior year. This represents the fifth consecutive quarter of sequential growth in testing services volumes.

然後，我將把電話轉給 Abhishek，他將在測試服務中進一步詳細審查我們的財務和指導假設。我們進行了約 44,600 次測試，比去年增加了 16%。這代表測試服務量連續第五個季度成長。

Testing services revenue was 60.8 million up 27% year over year including 1.2 million in revenue from tests performed in prior periods.

測試服務收入為 6,080 萬美元，比去年同期成長 27%，其中包括前期進行的測試帶來的 120 萬美元收入。

We have begun to execute the strategy we laid out at our 2024 investor day that will unlock profitable growth at CareDx by engaging transplant centers with solutions that include a synergistic portfolio of testing, digital and lab products and are seeing early successes with this strategy.

我們已開始執行在 2024 年投資者日制定的策略，該策略將透過為移植中心提供包括協同檢測、數位和實驗室產品組合在內的解決方案來釋放 CareDx 的獲利成長，並且該策略已取得早期成功。

The first step was to reorganize our go to market team into a structure that places our customers at the center of everything we do to capture the testing services growth opportunities ahead of us. We have already added 15 of a plan, 30 sales and marketing team members to promote and sell our leading transplant solutions.

第一步是重組我們的市場團隊，將其轉變為以客戶為中心的結構，以抓住我們面臨的測試服務成長機會。我們已經增加了 15 名銷售和行銷團隊成員，以推廣和銷售我們領先的移植解決方案。

In addition, we are adding 20 team members to our billing organization of which we have already hired approximately 10 team members to date to drive greater collections and expand our ASP.

此外，我們正在為我們的計費部門增加 20 名團隊成員，其中迄今為止我們已經僱用了大約 10 名團隊成員，以推動更多的收款並擴大我們的 ASP。

In Mid-August, the centers for Medicare and Medicaid services reaffirmed their commitment to covering testing for solid organ transplant monitoring including for surveillance. I anticipate. It will take 2 to 3 quarters for kidney transplant centers across the country to re adopt surveillance testing protocols.

8月中旬，醫療保險和醫療補助服務中心重申了對涵蓋實體器官移植監測測試（包括監測）的承諾。我預期。全國各地的腎臟移植中心將需要2到3個季度的時間重新採用監測測試協議。

Establishing a protocol at a transplant center is a departmental consensus process that may take several months to agree upon draft document and logistically implement the workflow.

在移植中心製定協議是一個部門共識過程，可能需要幾個月的時間才能就草案文件達成一致並在後勤上實施工作流程。

Since the beginning of September, 10 transplant centers that we work with have established new protocols that include kidney surveillance testing.

自 9 月初以來，我們合作的 10 家移植中心已經建立了包括腎臟監測測試在內的新協議。

And we began to see a shift in our testing mix towards surveillance in the second half of September that continued through the month of October, in their August press release. CMS signaled that a future draft LCD may be introduced that we anticipate may address the rapidly growing literature in this field including the recent Nature Medicine Multicenter study of 2,882 patients demonstrating that surveillance with aura kidney improves detection of all types of rejection.

我們在 8 月的新聞稿中表示，從 9 月下半月開始，我們的檢測組合開始向監測轉變，而這種轉變持續了整個 10 月。CMS 表示未來可能會引入一份 LCD 草案，我們預計該草案可能會解決該領域快速增長的文獻問題，包括最近對 2,882 名患者的自然醫學多中心研究，該研究表明使用 Aura 腎進行監測可以改善對所有類型排斥的檢測。

We continue to maintain an open line of communication and message advancements in the evidence supporting our shore testing to the agency and our mac contractors.

我們將繼續保持開放的溝通管道，並向該機構和我們的 mac 承包商通報支持我們岸上測試的證據進展。

For example, in October, the American Society of Transplant Surgeons issued a statement on the importance of serial testing using donor derived cell free DNA. In kidney and heart transplant patients in kidney, they recommended serial testing in patients with stable renal allograph function to exclude the presence of subclinical antibody mediated rejection and in patients with acute allograft dysfunction to exclude the presence of rejection in heart. They recommended using donor derived cell free DNA to rule out subclinical rejection.

例如，10月份，美國移植外科醫師協會發表了一份聲明，強調使用捐贈者來源的無細胞 DNA 進行系列檢測的重要性。對於腎臟和心臟移植患者，他們建議對腎移植功能穩定的患者進行系列檢測，以排除亞臨床抗體介導的排斥反應的存在，並對急性移植功能障礙的患者進行系列檢測，以排除心臟排斥反應的存在。他們建議使用捐贈者來源的無細胞 DNA 來排除亞臨床排斥。

They also recommended that clinicians using donor derived cell free DNA also utilize peripheral blood gene expression profiling such as our heart care solution as a non invasive diagnostic tool to rule out acute cellular rejection in stable low risk adult transplant recipients.

他們還建議使用供體來源的無細胞 DNA 的臨床醫生也利用外周血基因表達譜（例如我們的心臟護理解決方案）作為非侵入性診斷工具，以排除穩定的低風險成年移植接受者的急性細胞排斥。

On the commercial payer side. In the third quarter, we added 4 million commercial covered lives. And last week, Highmark Blue Cross Blue Shield issued a policy providing coverage for aure kidney for heart care coverage was expanded by Highmark to begin two months post-transplant from the previous coverage beginning six months post transplant.

在商業付款人方面。第三季度，我們增加了400萬商業受保人次。上週，Highmark Blue Cross Blue Shield 發布了一項政策，為 aure 腎臟移植提供心臟護理保險，Highmark 將保險範圍擴大到移植後兩個月開始，而先前的保險範圍從移植後六個月開始。

As of the end of the third quarter, we have gained approximately 31 million covered lives nationwide across our testing services business. We anticipate that this coverage coupled with the expansion of our revenue cycle management team will contribute to ASP growth that we will benefit from in future quarters.

截至第三季末，我們的檢測服務業務在全國已覆蓋約 3,100 萬人。我們預計，這種覆蓋範圍加上我們收入週期管理團隊的擴張將有助於我們在未來幾季受益的 ASP 成長。

Moving to our patient and digital solutions, we reported revenue of approximately 12 million representing 20% year over year growth.

至於我們的患者和數位解決方案，我們報告的收入約為 1,200 萬美元，年增 20%。

First, as we migrate customers from on prem to SAS products, we generate monthly recurring revenue and are able to improve our pricing.

首先，當我們將客戶從本地遷移到 SAS 產品時，我們會產生每月的經常性收入並能夠改善我們的定價。

Second, HLA labs that utilize our lab products are increasingly adopting our HLA lab information management software solution which we believe is best in class in the industry.

其次，使用我們實驗室產品的 HLA 實驗室越來越多地採用我們的 HLA 實驗室資訊管理軟體解決方案，我們認為該解決方案是業界最好的。

And third among our testing services customers, we continue to sell our transplant, pharmacy and medication adherence solutions to drive revenue growth in October. We signed an agreement with the University of California Health System which includes UCLAU, CS fuc Davis, UC San Diego and UC Irvine to implement med action plan. Our medication adherence SAS software application med action plan is clinically proven to improve patient medication adherence has been shown to contribute to significantly lowering 30 day readmission rates.

第三，在我們的檢測服務客戶中，我們繼續銷售移植、藥房和藥物依從性解決方案，以推動十月份的收入成長。我們與加州大學健康系統（包括加州大學洛杉磯分校、戴維斯分校電腦科學系、加州大學聖地牙哥分校和加州大學歐文分校）簽署了協議，實施醫療行動計畫。我們的藥物依從性 SAS 軟體應用程式藥物行動計畫經過臨床證明可以提高病患的藥物依從性，有助於顯著降低 30 天再入院率。

Collectively, the University of California Health System is one of the highest volume transplant health systems in the US.

整體而言，加州大學健康系統是美國移植業務量最大的健康系統之一。

As we shared during our 2024 Investor Day, we've seen that the performance of accounts that had three or more KDX digital Solutions have a significantly higher new patient acquisition rate for testing services. We're encouraged by this early result from our account and portfolio based approach aimed at addressing the needs of our center customers and creating long term customer stickiness.

正如我們在 2024 年投資者日所分享的那樣，我們發現擁有三個或更多 KDX 數位解決方案的帳戶的表現對於檢測服務的新患者獲取率明顯更高。我們基於帳戶和投資組合的方法旨在滿足中心客戶的需求並創造長期客戶黏性，這一早期成果令我們感到鼓舞。

Moving on to lab products, we reported revenue of 10.2 million representing 7% year over year growth.

談到實驗室產品，我們報告的收入為 1,020 萬美元，年增 7%。

The continued global adoption of our industry leading aice seek txngs based HL A typing kits primarily drove this growth.

推動這一成長的主要因素是我們行業領先的基於 aice seek txngs 的 HL A 打字套件在全球範圍內的持續採用。

We continue to innovate to offer best in class HLA typing products in the market.

我們不斷創新，為市場提供一流的 HLA 分型產品。

Two weeks ago, at the annual meeting of the American Society for Histocompatibility and Immunogenetics or ASI, the largest annual HL A lab meeting. We presented new data on Aice TX 11. The next generation of our Aice Asay with increased coverage of class two loi.

兩週前，在美國組織相容性和免疫遺傳學學會（ASI）的年會上，這是最大的年度 HL A 實驗室會議。我們展示了有關 Aice TX 11 的新數據。我們下一代的 Aice Asay 將擴大二級 loi 的覆蓋範圍。

We also announced the launch of our next generation assigned software for Aice Seek Txhl A typing featuring a newly improved user interface and streamlined workflow to view 24 or 96 multiplex, Aice seek TX samples in real time as results become available without waiting for the full batch to result.

我們也宣布推出用於 Aice Seek Txhl A 類型的下一代指定軟體，該軟體具有全新改進的用戶介面和簡化的工作流程，可查看 24 或 96 個多路復用，Aice 可在結果可用時實時尋找 TX 樣本，而無需等待整批結果出來。

We expect to make the new assigned software available to HL A lab customers in December of this year, adding a best in class software solution to complement our best in class A Seek NGS Chemistry at as we also announced our newly improved Q type rapid HL A typing solution for deceased donor organs, which now includes single bead antigen resolution to facilitate virtual cross matching for faster transplant organ allocation decisions.

我們預計將於今年 12 月向 HL A 實驗室客戶提供新的指定軟體，添加一流的軟體解決方案來補充我們一流的 A Seek NGS Chemistry，同時我們還宣布了我們新改進的針對已故捐贈器官的 Q 型快速 HL A 分型解決方案，該解決方案現在包括單珠抗原移植分辨率，從而更快地做出交叉器官匹配，從而更快地做出交叉器官匹配決策。

And finally, at Ashi, we also announced a partnership with dovetail genomics to launch an early access program combining Car dx's Aice Seek TX with dovetail genomics, high sea link prep technology to achieve high resolution genotyping and haplo typing. Without the need for family genotyping studies.

最後，在 Ashi，我們還宣布與 dovetail genomics 合作，啟動一項早期訪問計劃，將 Car dx 的 Aice Seek TX 與 dovetail genomics、high sea link prep 技術相結合，實現高分辨率基因分型和單倍體分型。無需進行家族基因分型研究。

The pairing of these technologies has the potential to improve transplant outcomes through better matching at the haplo type level.

這些技術的配對有可能透過單倍體類型水平的更好匹配來改善移植結果。

Our continued investment into HL A typing solutions demonstrates our ongoing commitment to delivering the most innovative solutions to support pre transplant recipient and donor matching across solid organ and stem cell transplantation.

我們對 HL A 分型解決方案的持續投資表明我們始終致力於提供最具創新性的解決方案，以支持實體器官和幹細胞移植前的移植接受者和捐贈者的匹配。

Moving on to our corporate business updates and guidance.

繼續介紹我們的公司業務更新和指導。

In Q3, we also made significant corporate progress. First, I added new senior executives to the company including a Chief Operating Officer, chief, commercial officer, and chief data and A I officer and reorganized our operating structure for long term profitable growth.

第三季度，我們的企業也取得了重大進展。首先，我為公司增加了新的高級管理人員，包括首席營運官、首席商務官、首席數據和人工智慧官，並重組了我們的營運結構，以實現長期盈利增長。

In addition, this past week, Chris Caesar, a seasoned market access professional from Pfizer, Myriad Genetics and most recently, Delphi Diagnostics has joined KDX to lead our global market access initiatives to drive coverage and reimbursement of our products.

此外，上週，曾任職於輝瑞、Myriad Genetics 以及最近加入德爾福診斷公司的經驗豐富的市場准入專家 Chris Caesar 加入了 KDX，領導我們的全球市場准入計劃，以推動我們產品的覆蓋和報銷。

Second, during our 2024 investor day held mid-October, we laid out the CareDx three-year growth strategy and financial plan to becoming the most innovative company in diagnostics. We are targeting to exit 2027 with 500 million in revenue, 20% adjusted ebita profitability and an additional 100 million in cash on our balance sheet.

第二，在 10 月中旬舉行的 2024 年投資者日上，我們制定了 CareDx 三年成長策略和財務計劃，旨在成為診斷領域最具創新力的公司。我們的目標是到 2027 年實現 5 億美元的收入、20% 的調整後息稅折舊攤提前利潤以及資產負債表上的額外 1 億美元現金。

Third, the Doj closed its investigation into KDI X with no findings of wrongdoing.

第三，美國司法部結束了對KDI X的調查，未發現任何不法行為。

The doj's decision follows the sec's decision in September of 2023 to close its investigation and take no action against KDX. We believe the closure of the doj's investigation underscores that the underlying allegations which have now been reviewed by two separate government agencies were meritless and fourth, a competitor has dropped their pursuit of patent infringement claims and a potential injunction against our current allosure testing method.

美國司法部的決定是在美國證券交易委員會於 2023 年 9 月決定結束調查並且不對 KDX 採取任何行動之後做出的。我們認為，司法部調查的結束強調了目前已由兩個獨立政府機構審查的基本指控是毫無根據的；第四，競爭對手已放棄對專利侵權索賠的追究以及對我們目前的封閉測試方法的潛在禁令。

While we believe competition is good for innovation and patient care, we will continue to defend the novel technology we first brought to market against what we view to be baseless claims of infringement. The jury verdict against K dx's prior aure process remains under court review and we intend to continue to push for the invalidation of all patents that have been asserted against us.

雖然我們相信競爭有利於創新和患者護理，但我們將繼續捍衛我們首次推向市場的新技術，反對我們認為毫無根據的侵權指控。對 K dx 先前專利流程的陪審團裁決仍在法庭審查中，我們打算繼續推動使所有針對我們的專利無效。

Now, turning to our guidance, giving our strong year-to-date results and expected growth for the remainder of the year. We are raising our revenue guidance for fiscal year 2024 to the range of 327 million to 331 million. From our prior guidance of 320 million to 328 million. A growth rate of approximately 17% year over year at the midpoint of our guidance from the midpoint of our revised guidance. We continue to target a growth CAGR over the coming three years of approximately 15%.

現在，談談我們的指引，給出我們今年迄今為止強勁的業績和今年剩餘時間的預期成長。我們將 2024 財年的營收預期上調至 3.27 億至 3.31 億之間。從我們之前預期的3.2億增加到3.28億。與修訂後的指引中點相比，我們的指引中點的年成長率約為 17%。我們仍將未來三年的複合年增長率定為約 15%。

We anticipate the pacing of that growth to accelerate from low teams in 2025 to high teams in 2027 excluding 14 million in one time revenue in 2024. The growth rate for 2025 is anticipated to be in the high 10s during our Q4 earnings call. We will provide further details on our full year 2025 guidance.

我們預計，除 2024 年 1,400 萬美元的一次性收入外，成長速度將從 2025 年的低收入加速到 2027 年的高收入。我們在第四季財報電話會議上預計 2025 年的成長率將達到 10% 左右。我們將提供有關 2025 年全年指導的更多詳細資訊。

In summary, we had a strong quarter with year over year growth across all our solutions including testing services, digital and lab products.

總而言之，我們本季表現強勁，所有解決方案（包括測試服務、數位和實驗室產品）均實現年增長。

I want to close by congratulating the transplant community including the hundreds of clinicians, thousands of patients and over a dozen members of Congress that advocated in support of monitoring assays for solid organ transplant rejection including for surveillance. We continue to advocate vigilantly on behalf of patients to ensure that they have the same longstanding access to monitoring assays that allow for early intervention of graft rejection and improved outcomes.

最後，我要向移植界表示祝賀，包括數百名臨床醫生、數千名患者和十幾名國會議員，他們倡導支持監測實體器官移植排斥反應的檢測方法，包括進行監測。我們將繼續為患者發出警告，確保他們能夠長期獲得監測檢測，以便儘早介入移植排斥並改善治療結果。

I will now turn the call over to Abhishek to share more details on our third quarter. Financials and our guidance. Abhishek.

現在我將把電話轉給 Abhishek，讓他分享有關我們第三季的更多詳細資訊。財務和我們的指導。阿布舍克。

Thank you John. In my remarks today, I will discuss our third quarter results before turning to revised 2024 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 SCC filings. Let me start with the key financial highlights report a total revenue of 82.9 million for the third quarter. Up 23% year over year delivered approximately 44,600 test results up 16% year over year and 2% as compared to the last quarter, representing the fifth consecutive quarter of sequential testing services volume growth reported testing services revenue of 60.8 million Up 27% year over year including 1.2 million associated with tests performed in the prior periods.

謝謝你，約翰。在今天的演講中，我將討論我們的第三季業績，然後再討論修訂後的 2024 年指引。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，請參閱我們新聞稿收益報告和最近的 SCC 文件中的 GAAP 與非 GAAP 對帳。首先我要介紹一下主要的財務亮點：第三季的總收入為 8,290 萬美元。年增 23%，共獲得約 44,600 份檢測結果，年增 16%，比上一季增長 2%，這是連續第五個季度實現檢測服務量增長，報告的檢測服務收入為 6,080 萬美元，同比增長 27%，其中包括前期進行的 120 萬美元。

Reported patient and distal solutions revenue of 11.9 million. Up 20% year over year and products revenue of 10.2 million. Up 7% year over year reported an adjusted EBITDA gain of 6.9 million compared to a 10.9 million loss in the same quarter of last year.

報告的患者和遠端解決方案收入為1190萬。年增20%，產品收入達1020萬。年增 7%，調整後 EBITDA 收益為 690 萬美元，而去年同期則虧損 1,090 萬美元。

Finally generated cash of 12.5 million from operations and ended the quarter with 241 million in cash cash equivalents and marketable securities.

最終從經營活動中產生了 1,250 萬美元的現金，並在本季末擁有 2.41 億美元的現金等價物和有價證券。

Moving to the details starting with gross margin. Our non-GAAP gross margin for the third quarter was 69% up 240 basis points as compared to non-GAAP gross margin of 66.6% in the same quarter last year.

從毛利率開始講細節。我們第三季的非公認會計準則毛利率為 69%，較去年同期的非公認會計準則毛利率 66.6% 上升 240 個基點。

Our CareDx testing services growth margin was 79% in the third quarter compared to 74% in the third quarter of 2023 the improvement in testing services, gross margin was driven by volume growth is the expansion as well as continued efficiencies in managing our lab operations.

我們的 CareDx 檢測服務成長利潤率在第三季為 79%，而 2023 年第三季為 74%，這是檢測服務的改善，毛利率是由數量成長、擴張以及實驗室營運管理效率的持續提高所推動的。

1.2 million in revenue associated with test performed in the prior period also added about 40 basis points to the non-capital margin.

與前期進行的測試相關的120萬美元收入也為非資本利潤增加了約40個基點。

Our patient and digital solutions non-GAAP gross margin for the third quarter was 37% as compared to 39% in the third quarter of 2023 excluding our transplant pharmacy, which has a low gross margin profile. Our patient in this solutions non-GAAP, gross margin for the third quarter was approximately 60%.

我們第三季的病患和數位解決方案非 GAAP 毛利率為 37%，而 2023 年第三季為 39%，不包括毛利率較低的移植藥局。我們患者在該解決方案的非GAAP，第三季的毛利率約為60％。

Our products non-GAAP gross margin was 46% in the third quarter, down from 58% in the third quarter of 2023. And in line with Nongaap gross margin of 47%. Last quarter, product gross margin can be impacted by the variability in our production schedule.

我們產品非 GAAP 毛利率在第三季為 46%，低於 2023 年第三季的 58%。與Nongaap 47%的毛利率一致。上個季度，產品毛利率可能會受到生產計畫變化的影響。

In the third quarter of 2023 gross margin was higher due to an end of life bulk bill for one of our HL A typing kits.

2023 年第三季度，由於我們的一款 HL A 打字套件的批量帳單終止使用，毛利率有所提高。

We anticipate another end of life bulk build in the fourth quarter of this year.

我們預計今年第四季將有另一批停產的批量產品。

Moving down the P&L Nongaap operating expenses for the third quarter were 52.2 million. Down approximately 5.5 million from the third quarter of 2023 and down 3 million from the previous quarter.

第三季的損益表 Nongaap 營業費用為 5,220 萬美元。較2023年第三季減少約550萬，較上一季減少300萬。

The quarter over quarter decrease in our operating expenses was primarily associated with lower conference costs. Push out of some expenses related to clinical trials and lower legal spend.

我們的營業費用環比下降主要由於會議費用的降低。推遲一些與臨床試驗相關的費用並降低法律支出。

Our adjusted debit again for the third quarter was 6.9 million compared to adjusted ifit a loss of 10.9 million in the third quarter of 2023. An improvement of 18 million.

我們第三季的調整後借方為 690 萬美元，而 2023 年第三季的調整後虧損為 1,090 萬美元。提高了 1800 萬。

This was driven by strong revenue growth, improved those margins and lower operating expenses excluding the 1.2 million in revenue associated with tests performed in the prior period adjusted again, would have been 5.7 million in the third quarter.

這是由於強勁的收入成長、利潤率提高和營運費用降低所致。

Turning to cash, we added approximately $12 million to our cash balance in the third quarter, primarily driven by cash generation from operating activities.

談到現金，我們在第三季的現金餘額增加了約 1,200 萬美元，主要得益於經營活動產生的現金。

We ended the quarter in a strong position with cash, cash equivalent and marketable securities of 241 million and no debt.

本季結束時，我們的狀況強勁，擁有現金、現金等價物和有價證券 2.41 億美元，且無債務。

Turning to guidance based on the performance across our business. In the third quarter of 2024 we are raising our full year revenue guidance to 327 to 331 million from our prior guidance of 320 to 328 million.

根據我們整個業務的表現來提供指導。2024 年第三季度，我們將全年營收預期從先前的 3.2 億至 3.28 億上調至 3.27 億至 3.31 億。

The midpoint of our 2024 guidance assumes testing services volume growth in the mid 10s and implied revenue growth of 30% year over year for the fourth quarter of 2024.

我們對 2024 年預期的中點假設測試服務量成長率在 10% 左右，並暗示 2024 年第四季的營收年增 30%。

The difference in our assumptions between volume and revenue growth is driven by ASP expansion in October, we experienced an impact of approximately 1% in testing volumes due to hurricane Milton.

我們假設的銷售量和收入成長之間的差異是由於 10 月 ASP 擴張造成的，由於颶風米爾頓，我們的測試量受到了約 1% 的影響。

This is incorporated in our device guidance.

這已納入我們的設備指南中。

We are assuming blended ASP of approximately 1,335 per test for the fourth quarter and no changes to our Medicare coverage.

我們假設第四季度的混合 ASP 約為每次測試 1,335，且我們的醫療保險覆蓋範圍沒有變化。

Our patient and Visal solutions is expected to grow in the mid 10 year over year.

我們的患者和 Visal 解決方案預計將在 10 年中期實現同比增長。

In Q3, we recognized revenue of 1 million in one time initial set up fee for the completion of HL A lab management software implementation.

第三季度，我們因完成HL A實驗室管理軟體實施而確認了100萬美元的一次性初始設定費收入。

We do not anticipate this recording in the fourth quarter.

我們預計第四季不會出現這項紀錄。

Our lab products will grow in the high 10s year over year moving to gross margin. We now expect our gross margin to be approximately 69% for the full year 2024 driven by the improved testing services growth margin.

我們的實驗室產品的毛利率將以每年 10% 以上的速度成長。我們現在預計，受測試服務成長幅度提高的推動，2024 年全年的毛利率將達到約 69%。

We're expecting a slight ramp up in our operating expenses in the fourth quarter associated with scaling of our commercial organization and billing operations to accelerate revenue growth in line with our growth strategy due to improved revenue expectations and gross margin. We expect our adjusted beda gain for the full year 24 to be between 18 and 22 million compared to previously guided gain of 9 to 15 million.

我們預計第四季度的營運費用將略有增加，這與我們商業組織和計費業務的擴大有關，以根據我們的成長策略加速收入成長，這是由於收入預期和毛利率的提高。我們預計 24 年全年調整後的 Beda 收益將在 1,800 萬至 2,200 萬美元之間，而先前預計的收益為 900 萬至 1,500 萬美元。

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

就這樣。現在我將把電話轉給約翰，讓他作結束語。

Thank you, Abhishek.

謝謝你，阿布舍克。

I want to reiterate how excited I am about CareDx future and the journey ahead we have the right team in place addressing the right market with the right products to deliver profitable growth.

我想重申我對 CareDx 的未來和未來之路感到非常興奮，我們擁有合適的團隊，以合適的產品針對合適的市場，實現盈利增長。

I want to thank the entire global CareDx team for their strong execution in the third quarter. And with that, I'd like to ask the operator to open the line for questions.

我要感謝整個全球 CareDx 團隊在第三季的出色表現。現在，我想請接線員開通熱線來回答問題。

(technical difficulty) Hello, are you there?

（技術難題）你好，你在嗎？

Yes, I did announce Bill Bonello with Craig Callum. Your line is open.

是的，我確實宣布了比爾·波尼洛和克雷格·卡勒姆的合作消息。您的線路已開通。

Hey, thanks. Hoping you guys are all there after that storm. So thank you.

嘿，謝謝。希望暴風雨過後你們都在。所以謝謝你。

Okay, good. Thank you so much for, for all of that information. I, a couple of questions just on the, on the Q4 guide. I guess I've, I've sort of thought in normalized circumstances as is Q4 being maybe a stronger quarter than, than Q3. Now, II, I get that, you know, you had a, you know, a little bit of prior period revenue this quarter, but even if you take that out, it, it seems like you're, you know, you're projecting revenue to be pretty flat. You know, sequentially, is there, is there anything you you've seen in October in terms of trends that that would make you a little more cautious than normal or how should we think about that?

好的，很好。非常感謝您提供的所有資訊。我對 Q4 指南有幾個問題。我想，在正常化的情況下，第四季可能比第三季表現更強勁。現在，II，我明白，您知道，本季度您有一點前期收入，但即使您將其去掉，您預計的收入似乎也會相當持平。您知道，按順序來說，您在十月份看到的趨勢是否有什麼讓您比平常更加謹慎，或者我們應該如何看待這一點？

So, Bill in the Q4 guidance, you're right that the revenue for Q4 is more or less in line with the Q3 and it's primarily driven by a couple of factors, one the prior items that I called out the $1.2 million in the testing services business and about a million dollars that I called out in our patient in this solutions business. So if you actually exclude these two items, then the Q4 revenue actually grows as compared to the Q3. And in our testing services business, for example, we are baking in volume growth from Q3 to Q4 in line with how we have seen the volume growth in the last year. So there is volume growth in the testing services business as well as the revenue growth.

因此，比爾，在第四季度的指引中，您說得對，第四季度的收入與第三季度基本一致，這主要是由幾個因素推動的，一個是我之前提到的測試服務業務的 120 萬美元，另一個是我提到的解決方案業務中的患者收入約 100 萬美元。因此，如果你實際上排除這兩項，那麼第四季度的收入實際上會比第三季度有所增長。以我們的測試服務業務為例，我們從第三季到第四季的銷售成長與去年同期的銷售成長一致。因此，測試服務業務的數量和收入都在成長。

Okay. That's helpful. I wasn't thinking about the, the, the the the million on the patient because I, I think if you back out the 1.2 million, you're still pretty flat. But maybe with the million, you, you get a little bit of growth and then I, I guess I, I'm just trying to wrap my head around the, the, the comment on, you know, the ramping of the growth and maybe being at low teams revenue growth for for next year. And I, I absolutely understand, you know what you're saying about the pacing of surveillance testing coming back and, and how that, you know, that will, that will take some you know, certainly take some time. But I mean, you know, you just reported a quarter where you had, you know, 23.5% growth. And even if you take out the unusual items, I think it's, you know, 20% plus growth and, you had a, you know, that kind of growth if not better, last quarter as well. And, you know, I think the, the implication for, for next quarter is, is sort of, you know, 25 ish percent, kind of year over year growth. So, so what happens that, that we just fall off all the way down to low 10s from sort of, you know, low 20s to mid 20s.

好的。這很有幫助。我沒有考慮病人身上的那一百萬，因為我認為如果放棄 120 萬，結果仍然相當平穩。但也許有了這個百萬，你會獲得一點成長，然後我，我想我，我只是試著理解關於成長加速的評論，也許明年團隊的收入成長率會較低。我完全理解您所說的有關監測測試恢復的步伐，以及這肯定需要一些時間。但我的意思是，你知道，你剛剛報告了一個季度，你的成長率是 23.5%。即使去掉不尋常的項目，我認為成長率也會超過 20%，上個季度也實現了這樣的成長，甚至更好。我認為這對下個季度的影響是同比增長 25% 左右。那麼，會發生什麼情況呢？

I can quickly make one comment and I'll give this back to John. So at the midpoint of our guide, year over year growth is about 17% is what we have called out be right? And if you were to take that one timer out, which is about $14 million then you're back to about 12% to 13% growth, which is pretty much in line with what John basically mentioned from the pacing of the revenue growth in 2025. And of course, as we start to invest in the commercial team and the billing operations, we will scale the growth at a higher number in the outer years of our 2027 plan.

我可以快速發表一條評論並將其交還給約翰。那麼，在我們的指導中點，年成長率約為 17%，這是我們所說的對嗎？如果你把這個時間去掉，也就是大約 1400 萬美元，那麼你的成長率就會回到大約 12% 到 13%，這與約翰基本上提到的 2025 年收入成長速度基本一致。當然，隨著我們開始投資商業團隊和計費業務，我們將在 2027 年計畫的後幾年內實現更高的成長。

Yeah, I think.

是的，我認為。

That's right.

這是正確的。

I I mean, Q1 was a bad quarter. So somewhere along the line, we should probably factor in another bad quarter or how do we, you know, I mean, Q1 was a, you know, it was sort of left over in how you had been growing before. So I guess that explanation kind of doesn't, I'm not tracking.

我的意思是，第一季是一個糟糕的季度。因此，在某個時候，我們可能應該考慮到另一個糟糕的季度，或者我們如何，你知道，我的意思是，第一季是你之前成長過程中遺留下來的。所以我猜這種解釋不太正確，我沒有追蹤。

And I thought that in Q1, there we grew like 6% on our testing services volume growth. So I thought that Q1 was like the growth was pretty decent. Maybe you might be kind of thinking from Q4 to Q1 and that would be more seasonal because of our product business.

我認為在第一季度，我們的測試服務量增加了 6%。所以我認為第一季的成長相當不錯。也許您可能會認為從第四季度到第一季度，由於我們的產品業務，這將更具季節性。

Yeah. Okay. Well, I I can follow up more offline but it doesn't, doesn't make a heck of a lot of sense to me. But thanks.

是的。好的。好吧，我可以離線跟進更多，但這對我來說沒有多大意義。但還是謝謝。

And once more for your questions, that is star and one, you may withdraw yourself from the queue at any time by pressing Star two. We'll move next to Jack Peterson with Jeffrey. Your line is open.

再次回答您的問題，即星號和一，您可以隨時按星號二退出佇列。接下來我們將與傑弗裡一起討論傑克·彼得森。您的線路已開通。

Hey, good evening. This is Jack on for Tyco. Just one question on testing mix. Looks like surveillance mix increased nicely in September through October. Could you put a finer point on the magnitude of this and may maybe speak to the upper limit? You know, of surveillance mix versus new transplants?

嘿，晚上好。我是泰科公司的傑克。關於測試混合物，只有一個問題。看起來九月至十月的監控組合有良好的成長。您能否更詳細地說明一下這個問題的嚴重程度並談談上限？您知道監測組合與新移植的差異嗎？

Thanks, Jack. We haven't, we haven't provided any detail on the proportional mix rate. I think directionally though what we said is we have seen, you know, a modest shift in that mix and we are seeing centers adopt protocols for surveillance testing and that we anticipate 2 to 3 quarters for that to return.

謝謝，傑克。我們沒有提供任何有關比例混合率的詳細資訊。不過我認為，從方向上看，我們已經看到這種組合發生了適度的變化，我們看到各中心採用了監測測試協議，我們預計這種情況將在 2 到 3 個季度後恢復。

Okay, that's fair. And then quickly on capital allocation and you're making nice progress in the P&L have over 230 million in cash. I guess. How are you thinking about capital allocation if deals aren't on the table? Should we assume any sort of buybacks in the near future? Thanks.

好的，這很公平。然後迅速進行資本配置，你在損益表方面取得了良好的進展，擁有超過 2.3 億美元的現金。我想是的。如果沒有交易，您會如何考慮資本配置？我們是否應該假設在不久的將來會出現任何形式的回購？謝謝。

Thanks Zach. I think that for us primarily we're thinking about growth and profitable growth long term. And, and then from there, we're going to look at ways to invest into the core business to grow more rapidly before moving into share buybacks. And so that's our, that's our prioritization set.

謝謝扎克。我認為我們主要考慮的是長期成長和獲利成長。然後，我們將從那裡開始，尋找投資核心業務的方法，以實現更快的成長，然後再進行股票回購。這就是我們的優先排序。

Okay. Thank you.

好的。謝謝。

We'll take our next question from Mark Massaro with BTIG. Your line is open.

我們將回答 BTIG 的 Mark Massaro 提出的下一個問題。您的線路已開通。

Hey guys, thank you for taking the questions. Congrats on the solid beaten raise. It's good to see the the feedback about the surveillance picking back up in the second half of September and continued through October. You guys talked about how and it makes sense to me that it may take 2 to 3 quarters for for transplant centers to establish surveillance protocols. But given that you saw a little bit of bounce back in September and October, I just want to make sure that doesn't preclude some degree of recovery relative to say the first half of 24 sort of continuing into 25 even before these protocols are established.

嘿夥計們，感謝你們回答問題。恭喜您成功加薪。很高興看到有關監測工作在 9 月下半月恢復並持續到 10 月的回饋。你們討論瞭如何做到這一點，我認為移植中心可能需要 2 到 3 個季度的時間來建立監測協議。但考慮到 9 月和 10 月出現了小幅反彈，我只想確保這不會妨礙一定程度的復甦，相對於 24 年上半年的複蘇，甚至在這些協議建立之前，這種復甦就會持續到 25 年。

Thanks, Mark, appreciate your question. No, we, we think this is additive on top of what we saw as we grew through the first half of 24 right? A lot of the growth we've seen in the, the five quarters since the change in the coverage kind of reset, the volume was really focused on the four cause area of indication and then growth in our heart care product.

謝謝，馬克，感謝您的提問。不，我們認為這是我們在 24 年前半段的成長基礎上的附加價值，對嗎？自從覆蓋範圍重新設定發生變化以來的五個季度中，我們看到了很多增長，增長量實際上集中在四大適應症領域，其次是心臟護理產品的增長。

Okay.

好的。

I also wanted to ask it, it seems like we are waiting for, I think it's palmetto GB A to finalize the L CD for transplant testing. Do you have any sense for when this might hit? And is it your understanding or impression that that the L CD might be restored back to what it was originally? Just give us a sense for what your expectations are heading in?

我也想問一下，好像我們在等待，我認為是棕櫚 GB A 來完成 L CD 的移植測試。您是否知道這種情況何時會發生？您是否瞭解或認為 LCD 可以恢復到原來的狀態？請告訴我們您的期望是什麼？

Thanks. Thanks for the question mark. Yeah, we, we don't have a specific timeline from the agency or from palmetto as to when a new draft L CD would be released. Currently, the active L CD is the 2021 L CD that was originally published covering this indication broadly. And we anticipate that any future L CD would include an update to the literature which has progressed significantly since 2021 to include some of the more I would say foundational studies like the nature and Medicine publication that I talked to in my prepared remarks.

謝謝。謝謝你的問號。是的，我們沒有從該機構或 Palmetto 獲得有關何時發布新的 L CD 草稿的具體時間表。目前，有效的 L CD 是最初發布的 2021 L CD，廣泛涵蓋了這種適應症。我們預計，任何未來的 L CD 都將包含文獻的更新，這些文獻自 2021 年以來取得了重大進展，其中包括一些我認為是基礎性的研究，例如我在準備好的發言中提到的《自然與醫學》出版物。

Okay. I have one final two parter. Should we in Q4 from, from hurricane Milton? And then the second part, which is completely unrelated. How are you thinking about, potential expansion of com commercial payer lives in 2025? II, I saw you hired, you made a new hire on the commercial access team. Just give us a sense for what the order, you know, what the objectives are in 25. Obviously 24 was a good year of new payer coverage.

好的。我還有最後兩個部分。我們是否應該在第四季度關注颶風米爾頓？然後是第二部分，這與主題完全無關。您如何看待 2025 年商業付款人生活的潛在擴展？II，我看到你被聘用了，你在商業訪問團隊中聘用了一名新員工。請告訴我們具體順序，以及 25 中的目標是什麼。顯然，24 年對於新付款人覆蓋來說是一個好的年份。

It was. Yeah, thanks for the questions mark. On your first question related to Milton. Yes, we have seen a 1% volume impact in the fourth quarter and we have not yet gain that volume back. And thus, Abhishek called that out in his prepared remarks as being incorporated into our guide for the fourth for the full year of 2024. And then as it relates to a payer expansion.

是的。是的，謝謝你的問號。關於你的第一個問題與米爾頓有關。是的，我們看到第四季度的銷量受到了 1% 的影響，而且我們還沒有恢復這一銷量。因此，阿布舍克在準備好的發言中指出，這一點已納入我們 2024 年全年第四季指南中。然後它與付款人擴充功能相關。

Yes, we absolutely believe that 2025 should be a significant year for covered lives expansion, particularly in Alao heart and Alao kidney. We have in heart additional publications that we anticipate from the shore study to come out in kidney. We are awaiting the publication of the Kor study which we think would be significant to drive coverage for a kid on top of the Nature Medicine Publication, which only has been out for about a quarter and we continue to talk with with Payers about that data and the significance of that data.

是的，我們絕對相信 2025 年應該是擴大人壽保險覆蓋範圍的重要一年，尤其是在 Alao 心臟和 Alao 腎臟方面。我們期待在腎臟方面的研究中發表更多出版品。我們正在等待 Kor 研究的發表，我們認為這項研究對於推動兒童醫療保險覆蓋範圍的擴大具有重要意義，這將超越《自然醫學出版物》，而《自然醫學出版物》僅出版了約一個季度，我們將繼續與付款人討論這些數據及其重要性。

Okay, thanks for taking my question.

好的，感謝您回答我的問題。

Thanks, Mark.

謝謝，馬克。

We'll move next to Brandon Perry with Wells Fargo. Your line is open.

接下來我們參觀富國銀行的布蘭登·佩里。您的線路已開通。

Hey, thanks, good afternoon. John, it'd be great if you could just talk about, you know, the 30 planned new heads in the commercial organization. How much of an increase in terms of percentage is that relative to the prior base where we kind of allocate to those people in terms of scope of focus. And then AJ is kind of 8 to $10 billion the right ballpark for incremental spend from that build out.

嘿，謝謝，下午好。約翰，如果你能談談商業組織計劃任命的 30 位新負責人的話，那就太好了。就百分比而言，相對於我們先前分配給這些人的關注範圍的基礎，增加了多少？然後 AJ 的規模大概是 800 到 100 億美元，這是該建設的增量支出的正確估計範圍。

Yeah, great. Thanks Brandon. Appreciate the question. The the commercial heads are allocated between field sales and marketing. If you recall back in 2023 the company cut pretty significantly across the organization to control our spend and, and maintain our cash balance. So we drew down, you know, across the board. And so this is a reinvestment in the commercial organization that includes probably about third in marketing and two thirds in field sales that will be customer facing revenue generating team members.

是的，很棒。謝謝布蘭登。我很感謝你提出這個問題。商業主管被分配到現場銷售和行銷部門。如果您還記得，2023 年，公司大幅削減了整個組織的開支，以控制我們的支出並維持我們的現金餘額。因此，你知道，我們全面削減了開支。因此，這是對商業組織的再投資，其中大概包括三分之一的行銷資金和三分之二的現場銷售資金，這些資金將是面向客戶的創收團隊成員。

And I can take the quick the second part and your number is in the ballpark, Brandon, roughly $10 million for the head that we basically kind of mentioned here.

我可以快速地說出第二部分，布蘭登，你的數字大概是 1000 萬美元，我們基本上在這裡提到的頭部價格大約是 1000 萬美元。

Okay. So this would.

好的。所以這樣就可以了。

Basically get you back to where you were before the C MS spelling article. Is, is that the right way to think about it then.

基本上讓您回到 C MS 拼字文章之前的狀態。那麼，這是正確的思考方式嗎？

That's kind of the way we're thinking about it.

我們就是這樣思考這個問題的。

We, we have been incredibly efficient as a commercial organization over the past five quarters in driving growth and in order to continue to drive that growth and accelerate it over the next several years, we're starting with this 30 head count and we'll provide additional updates if we decide to add more in the field to capture that volume opportunity that we have.

作為一個商業組織，我們在過去五個季度中一直非常有效率地推動成長。

Okay. That's, that's helpful. And then as far as I don't know if you're agree to what you're willing to go into this much detail, but I'll give it a shot. So, relative to the low teams kind of growth you pointed to next year, first AJ is the fourth quarter ASP a good jump off assumption for next year, assuming you will, you should continue to benefit from expanded commercial coverage. And should we expect that the second half of next year to be stronger than the first half? Given your comments about the, the, the lag that it will take for the surveillance protocols to come back online. Thanks.

好的。這很有幫助。至於我不知道您是否同意如此詳細地說明，但我會嘗試一下。因此，相對於您所指出的明年團隊的低成長，首先 AJ 是第四季度 ASP 對明年的一個良好起點假設，假設您願意，您應該繼續受益於擴大的商業覆蓋範圍。我們是否應該預期明年下半年會比上半年表現強勁？考慮到您關於監控協議恢復在線所需的滯後的評論。謝謝。

No, you're thinking it the right way, Brandon because the ASP of 1,335 that will be the point of the 2025 numbers as you will start to think about it. And of course, the low teams guide for 2025 will provide more color in our earnings. But that's where you should start to kind of think from the modeling standpoint, the 2025. And the last piece of your question around the second half being a little bit more stronger. You're again thinking it the right way because as we build our commercial organization, as well as the billing organization, typically, it takes about 1 to 2 quarters before they become fully effective. And therefore you might be kind of thinking a little bit more growth in the second half of the year.

不，布蘭登，你的想法是正確的，因為 1,335 的 ASP 將成為 2025 年數字的重點，你會開始思考這個問題。當然，2025 年的低收入球隊指南將為我們的收入提供更多參考。但從建模的角度來說，你應該開始思考 2025 年。你問題的最後一個部分是關於下半部的，要更有力。您再次認為這是正確的，因為當我們建立商業組織以及計費組織時，通常需要大約 1 到 2 個季度才能完全生效。因此，你可能會認為今年下半年會有更多的成長。

Good. Thank you.

好的。謝謝。

Thanks Brandon.

謝謝布蘭登。

We'll take our next question from Yi Chen with HC Wainright. Your line is open.

下一個問題由 HC Wainright 的 Yi Chen 提出。您的線路已開通。

Thank you for taking my question. Could you comment on the general trend that expect to occur regarding the number of transplant or transplantation procedures in 2025? And what are the factors driving this trend? Thank you.

感謝您回答我的問題。您能否評論一下 2025 年移植數量或移植程序的整體趨勢？那麼，推動這趨勢的因素有哪些呢？謝謝。

Hi En for 2025. In our investor day, we talked about mid single digit secular growth of the transplant market as being the baseline that we built our plan off of.

2025 年，Hi En。在我們的投資者日，我們討論了移植市場的中等個位數長期成長作為我們制定計劃的基準。

Do you think there's any reason that, that we should believe there, there should be more on a fewer number of a number of transplant procedures in 2025.

您認為，我們是否有理由相信，到 2025 年，移植手術的數量應該會增加而不是減少？

We don't have any, any catalysts to point to right now in terms of more procedures. The I think that the introduction of perfusion technologies has accelerated the growth to where it is today across the full market. We're seeing heart, heart and lung grow at a faster pace than kidney, obviously off a smaller end sample size. And I think the only changes that could really accelerate this further would be a government intervention of government programs. Recently, it was announced that the IOT a model for kidney transplant was going to be delayed in its implementation. And so we're awaiting, you know, further guidance from the agency regarding that program and its impact that it'll have on the market.

就更多程序而言，我們目前還沒有任何可以指出的催化劑。我認為灌注技術的引入加速了整個市場的成長，使其達到今天的水平。我們發現心臟、心臟和肺的生長速度比腎臟快，顯然樣本量較小。我認為能夠真正進一步加速這一進程的唯一變化是政府乾預政府計劃。最近，有消息指出腎臟移植IOT模式的實施將被推遲。因此，我們正在等待該機構就該計劃及其對市場的影響提供進一步的指導。

Got it.

知道了。

Thank.

感謝。

You.

你。

We'll take our next question from Mason Carrico with Stevens Inc, your line is open.

我們將回答 Stevens Inc 的 Mason Carrico 提出的下一個問題，您的熱線已經開通。

Hey guys, sorry if this has been asked jumping between a few calls tonight. But how should we be thinking about the framework for the surveillance opportunity going forward? You know, there are 25,000 or so kidney transplants a year. They're obviously a lot more patients living with it transplant right now. Is the opportunity at least near term really more about rolling those newly transplanted patients into surveillance after that 1st year. Is there a plan to go out and expand patients who maybe are a few years out from transplant? You just more than 12 months give it, give us some color on how you're thinking about it.

嘿夥計們，如果今晚在幾個電話之間問到這個問題，我很抱歉。但是，我們該如何思考未來監控機會的框架呢？你知道，每年大約有25,000例腎臟移植手術。顯然，現在有更多的患者接受移植手術。至少短期內的機會是否真的更多是關於在第一年之後將這些新移植的患者納入監測範圍。是否有計劃擴大可能還需要幾年才能接受移植的患者範圍？你只需要給它 12 個多月的時間，告訴我們你對此有何看法。

Thanks Mason. I, I appreciate the question. Yes, I think you're thinking about it correctly. We're really targeting the 1st year post transplant for an implementation of a protocol to perform surveillance testing. That's where I believe the medical necessity is the greatest, right? The the vast majority of rejection occurs in that 1st year. And thus, as centers think about implementing protocols, calls and re initiating surveillance testing, they're going to do so on newly transplanted patients, not on those that are, you know, 3 to 5 years out from transplant. We think in that, in that group, there continues to be interest particularly in for cause testing as we think about reducing immunosuppression in those patients. And then recently, there's been a number of articles and studies, peer reviewed studies looking at antibody mediated rejection, including new therapeutics for antibody mediated rejection and the impact of those therapeutics when that condition is detected earlier. And we know that Aure in particular has demonstrated created the ability to detect antibody mediated rejection before biopsy proven rejection. And so we think as that market grows and more therapeutics come to market for that indication that there'll be greater demand in the out years for surveillance testing to detect those events and treat and elongate graft survival.

謝謝梅森。我，我很感謝你提出這個問題。是的，我認為你的想法是正確的。我們真正的目標是在移植後的第一年實施一項協議來執行監測測試。我認為那裡的醫療需求最大，對嗎？絕大多數的拒絕都發生在第一年。因此，當中心考慮實施協議、呼叫並重新啟動監測測試時，他們會針對新移植的患者進行這些操作，而不是針對距離移植還有 3 到 5 年的患者。我們認為，在該組中，人們繼續對病因測試特別感興趣，因為我們考慮減少這些患者的免疫抑制。最近，有許多文章和研究、同行評審的研究探討抗體介導的排斥反應，包括抗體介導排斥反應的新療法以及當早期發現這種情況時這些療法的影響。我們知道，Aure 已證明能夠在活檢證實排斥之前檢測出抗體介導的排斥反應。因此，我們認為，隨著該市場的成長和更多療法的上市，未來幾年對檢測這些事件、進行治療並延長移植物存活時間的監測測試的需求將越來越大。

Got it. I'll keep it there. Thanks. That was helpful.

知道了。我會把它放在那裡。謝謝。這很有幫助。

Thanks Mason.

謝謝梅森。

We'll move next to Thomas DeBourcy with Nephron Research. Your line is open.

接下來我們來談談 Nephron Research 的 Thomas DeBourcy。您的線路已開通。

The guy is KDI.

這傢伙是 KDI。

We can. Okay, great. So my question just, I guess maybe goes back to a few years ago, maybe earlier the launch where, you know, there was a focus on a number of transplant centers. You know, I guess discussion at that point, you know, approximately 100 100 25 setters account for most of the volume. And I guess, you know, just kind of wondering, you know, with all that has transpired, you know, what, you know, I guess what has been your set of retention, you know, over the last few years and then also not that there is a generalization but in terms of implementing new protocols around surveillance, would you expect it to take, you know, on average, you know, 23 quarters longer and I know there's maybe a dispersion but just kind of any thoughts you have there just, you know, related to, you know, kind of the blocking attack like around transplant centers.

我們可以。好的，太好了。所以我的問題可能要追溯到幾年前，也許是更早的時候，當時人們關注的是一些移植中心。您知道，我猜在那時的討論中，大約 100 個 25 個 setter 佔據了大部分的音量。我想，我只是有點好奇，在發生了這麼多事情之後，過去幾年您的保留計劃是怎樣的？ 而且，這也不是一概而論，而是在實施新的監控協議方面，您是否預計平均需要多花 23 個季度的時間？ 而且，這也不是一概而論，而是在實施新的監控協議方面，您是否預計平均需要多花 23 個季度的時間？ 而且，這也不是我知道可能存在偏差，但您有什麼想法，與移植中心周圍的阻止攻擊有關嗎？

Yeah, thanks. Thanks so much for the question, Thomas to your first question around retention. I mean, yes, we've seen a high level of retention and, and you know, our, our products tend to be sticky with our customers because of the large solution set that we offer them across digital HL A typing and testing services.

是的，謝謝。非常感謝您的提問，托馬斯，您的第一個問題是關於保留。我的意思是，是的，我們看到了很高的保留率，而且你知道，我們的產品往往對客戶具有粘性，因為我們在數位 HL A 打字和測試服務方面為他們提供了龐大的解決方案集。

And then as it relates to protocols, there's a, there's a varying degree of readiness to implement. So as I shared in my prepared remarks, we have 10 centers across the country that have already drafted and implemented to varying degrees new protocols. Since September the first, many of the clinicians at the centers recognize that the care of their patients has been impacted by turning off surveillance. And so they're eager to get going again and we are staffing up to support that effort by adding more commercial team members so that we're prepared to support them in the logistics and workflow for implementing a ashore testing to get back to the high level of care and outcomes they expect for their patients.

然後，由於它與協議相關，因此存在不同程度的實施準備。正如我在準備好的演講中所說，我們全國有 10 個中心已經起草並不同程度地實施了新的協議。自 9 月 1 日以來，許多中心的臨床醫生都意識到關閉監控對患者的照護產生了影響。因此，他們渴望再次出發，我們也在增加人員來支持這項工作，增加更多的商業團隊成員，以便我們準備在物流和工作流程方面為他們提供支持，實施岸上測試，以恢復他們期望為患者提供的高水平護理和結果。

Great. That was all I had appreciate it.

偉大的。這就是我全部的感激。

Thank you.

謝謝。

And this does conclude the question and answer portion of the call. Thank you, ladies and gentlemen for joining, you may disconnect at this time and have a wonderful evening.(Operator Instructions)

本次通話的問答部分到此結束。謝謝各位的加入，女士們，先生們，現在您可以掛斷電話並享受美好的夜晚。