CareDx Inc (CDNA) 2024 Q1 法說會逐字稿

Good day, everyone, and welcome to today's CareDx, Inc. First Quarter 2024 Earnings Conference Call. (Operator Instructions) Please note, this call is being recorded, and I will be standing by if you should need any assistance.

大家好，歡迎參加今天的 CareDx, Inc. 2024 年第一季財報電話會議。（操作員說明）請注意，此通話正在錄音，如果您需要任何協助，我將隨時待命。

It is now my pleasure to turn today's conference over to Greg Chodaczek. Please go ahead, sir.

現在我很高興將今天的會議交給 Greg Chodaczek。請繼續，先生。

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

謝謝特拉維斯，下午好，謝謝您今天加入我們。今天早些時候，CareDx 發布了截至 2024 年 3 月 31 日的季度財務表現。該版本目前可在公司網站 www.caredx.com 上取得。約翰漢納，總裁兼執行長；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. 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, are 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. 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.

在我們開始之前，我想提醒大家，管理層將在本次電話會議中發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據私人證券訴訟改革的安全港條款做出的1995年法案。本次電話會議中包含的任何非歷史事實陳述的陳述均應被視為前瞻性陳述。所有前瞻性陳述，包括但不限於對歷史營運趨勢的審查、有關承保決策、定價和註冊事宜的預期以及我們的財務預期和結果，均基於當前的估計和各種假設。這些陳述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陳述預期或暗示的結果有重大差異。

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 Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, May 9, 2024.

因此，您不應過度依賴這些陳述。有關與我們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（2024 年 5 月 9 日）的直播。

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.

除法律要求外，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，無論是由於新資訊、未來事件或其他原因。

This call will be -- will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation to the most directly 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.

這次電話會議還將包括對某些不按照公認會計原則計算的財務指標的討論。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公認會計準則財務指標的調節。我現在將把電話轉給約翰。

Thank you, Greg, and to everyone for joining today's call. I want to start by thanking our CareDx employees and the transplant community for their warm welcome. It is an honor to be a part of this organization and its mission to improve transplant patient outcomes by providing innovative testing, and digital and product solutions globally.

謝謝格雷格和大家參加今天的電話會議。首先，我要感謝 CareDx 員工和移植社群的熱情歡迎。我很榮幸成為該組織的一員，其使命是透過在全球範圍內提供創新的測試、數位和產品解決方案來改善移植患者的治療結果。

Before I begin with my prepared remarks on our first quarter 2024 performance, I want to acknowledge an exciting new development that emerged yesterday. The Centers for Medicare and Medicaid Services announced a new initiative called the Increasing Organ Transplant Access Model. The proposed initiative aims to increase access to kidney transplants for all people living with end-stage renal disease. In the program, participating transplant hospitals would be measured by increases in the number of kidney transplants, increased organ acceptance rates, and post-transplant outcomes.

在我開始對 2024 年第一季業績發表準備好的評論之前，我想對昨天出現的一個令人興奮的新進展表示認可。醫療保險和醫療補助服務中心宣布了一項名為「增加器官移植取得模式」的新措施。該倡議旨在增加所有末期腎病患者獲得腎臟移植的機會。在該計劃中，參與的移植醫院將透過腎臟移植數量的增加、器官接受率的增加和移植後的結果來衡量。

We are pleased to hear about this latest development and the potential it holds for the approximately 90,000 patients on the organ transplant list awaiting a new kidney. The CMS initiative is a proposed 6-year mandatory program for approximately 50% of all kidney transplant hospitals in the U.S. scheduled to begin on January 1, 2025. For CareDx, we anticipate this initiative to be a tailwind for the adoption of our solutions that improve patient transplant outcomes, a critical component to the program's evaluation.

我們很高興聽到這一最新進展及其對器官移植名單上等待新腎臟的約 90,000 名患者的潛力。CMS 計劃是一項針對美國約 50% 的腎臟移植醫院的為期 6 年的強制性計劃，計劃於 2025 年 1 月 1 日開始。對於 CareDx 來說，我們預計這一舉措將成為採用我們改善患者移植結果的解決方案的順風車，這是該計劃評估的關鍵組成部分。

Turning to our results. Our first quarter results are better than anticipated, stemming from growth across all businesses and our operational discipline. I will start today's call by sharing highlights from the quarter, including examples of the significant value our solutions create for patients and transplant centers that is driving our growth. Then I will turn the call over to Abhishek for a detailed look at our financials and outlook for 2024.

轉向我們的結果。我們第一季的業績優於預期，這得益於所有業務的成長和我們的營運紀律。我將在今天的電話會議中首先分享本季度的亮點，包括我們的解決方案為患者和移植中心創造的重大價值的範例，這些價值推動了我們的成長。然後我會將電話轉給 Abhishek，詳細了解我們的財務狀況和 2024 年的前景。

CareDx posted strong growth in the first quarter that builds upon the momentum created in the second half of 2023. For the first quarter, we reported revenue of $72 million, up 10% from the prior quarter. In the testing services business, we delivered approximately 42,000 tests, up 6% from the fourth quarter and representing the third consecutive quarter of growth in testing services volumes. Revenue was $53.8 million, up 8% quarter-over-quarter, primarily excluding onetime collections from tests performed in prior quarters.

CareDx 在 2023 年下半年創造的勢頭基礎上，在第一季實現了強勁增長。第一季度，我們報告營收為 7,200 萬美元，比上一季成長 10%。在測試服務業務方面，我們交付了約42,000次測試，較第四季成長6%，測試服務量連續第三個季度成長。收入為 5380 萬美元，環比增長 8%，主要不包括前幾季度進行的測試中的一次性收集。

Our testing services business is propelled by continued innovation that is highlighted in a growing body of clinical evidence supporting the clinical utility of our solutions, HeartCare, AlloSure Kidney, and AlloSure Lung. At the International Society of Heart and Lung Transplantation Annual Meeting in Prague, our products were featured in over 30 oral presentations, posters and 2 symposia. In an oral presentation of late-breaking clinical study data, the first peer-reviewed findings from our large multicenter Surveillance of HeartCare Outcomes Registry, or SHORE, were presented during an ISHLT scientific session. The SHORE study is the largest prospective observational study of its kind in heart transplantation with 67 participating centers, over 2,700 patients enrolled, encompassing over 11,000 patient encounters.

我們的測試服務業務受到持續創新的推動，越來越多的臨床證據支持我們的解決方案 HeartCare、AlloSure Kidney 和 AlloSure Lung 的臨床實用性，這一點凸顯了這一點。在布拉格舉行的國際心肺移植學會年會上，我們的產品出現在 30 多個口頭報告、海報和 2 個研討會中。在最新臨床研究數據的口頭介紹中，我們的大型多中心心臟護理結果監測登記處 (SHORE) 的第一個同行評審結果在 ISHLT 科學會議期間提出。SHORE 研究是心臟移植領域中同類中規模最大的前瞻性觀察性研究，有 67 個參與中心、超過 2,700 名患者入組，涵蓋超過 11,000 名患者就診。

Independent researchers presented results that demonstrated that surveillance testing with HeartCare, the combined use of both AlloSure Heart and AlloMap Heart outperformed testing with donor-derived cell-free DNA alone in characterizing patients' risk for acute rejection. Notably, dual positive results from HeartCare in the first 6 months also predicted poor outcomes at 2 years compared to patients with donor-derived cell-free DNA positive results alone or dual negative results in the first 6 months. These findings support the prognostic value of HeartCare. These data are highlighted in our earnings presentation.

獨立研究人員提出的結果表明，在描述患者急性排斥風險方面，HeartCare 監測測試（AlloSure Heart 和 AlloMap Heart 的組合使用）優於單獨使用供體來源的遊離 DNA 的測試。值得注意的是，與前 6 個月僅獲得供者來源的無細胞 DNA 陽性結果或雙陰性結果的患者相比，前 6 個月內 HeartCare 的雙陽性結果也預示著 2 年後的不良結果。這些發現支持 HeartCare 的預後價值。這些數據在我們的收益報告中得到了強調。

We believe the SHORE study findings are significant and have the potential to transform the way providers care for heart transplant patients because of the clinical importance of having both AlloMap gene expression profiling and AlloSure donor-derived cell-free DNA to assess allograft health.

我們相信SHORE 研究結果意義重大，並且有可能改變提供者護理心臟移植患者的方式，因為使用AlloMap 基因表達譜和AlloSure 供體來源的無細胞DNA 來評估同種異體移植物的健康狀況具有臨床重要性。

We believe that HeartCare has the potential to become the new standard of care and surveillance biopsies will be performed more sparingly. We anticipate the first of several publications generated from the rich data set created by the SHORE study to be in print this year.

我們相信 HeartCare 有潛力成為新的護理標準，並且將更加謹慎地進行監測活檢。我們預計，由 SHORE 研究創建的豐富資料集所產生的幾份出版物中的第一份將於今年出版。

Many in the transplant clinical community have already taken note of HeartCare's impact on outcomes. Stanford University has led the way as one of the earliest adopters of HeartCare in their journey to discover cases of subclinical rejection non-invasively. Stanford implemented a HeartCare protocol, which allowed the center to shift further away from using surveillance biopsies to routinely incorporating noninvasive HeartCare testing. They have eliminated greater than 90% of biopsies in patients with dual positive results. And importantly, outcomes have remained excellent. Improving the outcomes of transplant patients at centers like Stanford is driving the adoption of our testing solutions.

移植臨床界的許多人已經注意到 HeartCare 對結果的影響。史丹佛大學是 HeartCare 最早採用者之一，在非侵入性發現亞臨床排斥病例的過程中處於領先地位。史丹佛大學實施了 HeartCare 協議，該協議使該中心進一步從使用監測活檢轉向常規納入非侵入性 HeartCare 測試。他們消除了超過 90% 的雙重陽性患者的活檢。重要的是，結果仍然非常出色。改善史丹佛等中心的移植患者的治療效果正在推動我們的測試解決方案的採用。

Building upon the clinical evidence emerging for HeartCare, AlloSure Kidney, and AlloSure Lung, we successfully expanded medical policy coverage with Blue Cross Blue Shield plans and other private commercial payers for 14 million lives in the quarter. Payers are acknowledging the utility of our testing solutions in improving patient outcomes. We anticipate that coverage, coupled with our focused efforts in revenue cycle management, should continue to contribute to margin growth in future quarters.

基於 HeartCare、AlloSure Kidney 和 AlloSure Lung 的臨床證據，我們透過 Blue Cross Blue Shield 計劃和其他私人商業付款人成功擴大了本季 1400 萬人的醫療政策覆蓋範圍。付款人承認我們的測試解決方案在改善患者治療效果方面的效用。我們預計，這一覆蓋範圍，再加上我們在收入周期管理方面的重點努力，應會繼續為未來幾季的利潤成長做出貢獻。

Lastly, on our Medicare coverage efforts, there continues to be significant pressure from transplant patient advocacy groups, clinicians and CareDx to restore the long-standing coverage, which has primarily affected kidney transplant patients. We will be unwavering in our efforts to address this policy issue.

最後，在我們的醫療保險覆蓋範圍方面，移植患者倡導團體、臨床醫生和 CareDx 繼續面臨巨大壓力，要求恢復長期覆蓋範圍，這主要影響了腎臟移植患者。我們將堅定不移地努力解決這項政策問題。

Moving on to our patient and digital Solutions business, where we had a good quarter with $9.6 million in revenue, a year-over-year growth of 12%. Currently, over 70% of transplant centers in the U.S. use at least one of our patient and digital solutions. After acquiring one of our solutions, such as our quality reporting software, and experiencing positive outcomes, we frequently see an uptake of additional value-added solutions such as administrative staff augmentation or patient medication adherence services.

接下來是我們的患者和數位解決方案業務，該業務季度表現不錯，收入為 960 萬美元，年增 12%。目前，美國超過 70% 的移植中心至少使用我們的一種患者和數位解決方案。在獲得我們的一種解決方案（例如我們的品質報告軟體）並獲得積極成果後，我們經常看到其他增值解決方案的採用，例如行政人員擴充或患者用藥依從性服務。

For example, Tampa General has become a significant user of our patient and digital health solutions. They have adopted 4 products over the last 18 months, addressing their needs, including patient care coordination, quality improvement, HLA lab operations management and logistics support. We are integrated with their EMR system, enabling them to provide digitally enhanced patient care. As a result, they have improved their quality measurement scores, operational efficiencies and resource utilization across all stages of their transplant patient workflow. They recently sought our assistance in refining their wait listing process to increase the throughput of transplantation at their center. Our work with Tampa General demonstrates, how CareDx's patient and digital solutions establish us as a trusted and essential partner to the success of their transplant program.

例如，坦帕綜合醫院已成為我們的病患和數位健康解決方案的重要使用者。他們在過去 18 個月中採用了 4 種產品來滿足他們的需求，包括病患照護協調、品質改進、HLA 實驗室營運管理和後勤支援。我們與他們的電子病歷系統集成，使他們能夠提供數位化增強的患者護理。因此，他們提高了移植病患工作流程所有階段的品質測量分數、營運效率和資源利用率。他們最近尋求我們的幫助來完善他們的等候名單流程，以提高他們中心的移植吞吐量。我們與 Tampa General 的合作展示了 CareDx 的患者和數位解決方案如何使我們成為其移植計劃成功的值得信賴且重要的合作夥伴。

Finally, in our Products business, we achieved $8.6 million in revenue in the quarter, a 25% year-over-year growth, primarily driven by the continued adoption of our industry-leading AlloSeq Tx NGS-based HLA typing kits. AlloSeq Tx delivers comprehensive results to HLA laboratories to help identify the best genetic match for organ transplant recipients. LifeLink Foundation's HLA laboratory recently converted from legacy HLA typing solutions using real-time PCR methods to NGS-based AlloSeq Tx because it eliminates the need for reflux testing to resolve ambiguous results and increases operational efficiencies.

最後，在我們的產品業務中，本季度我們實現了 860 萬美元的收入，年增 25%，這主要是由於我們行業領先的 AlloSeq Tx NGS 基於 HLA 分型試劑盒的持續採用。AlloSeq Tx 為 HLA 實驗室提供全面的結果，幫助確定器官移植受者的最佳基因匹配。LifeLink 基金會的 HLA 實驗室最近從使用即時 PCR 方法的傳統 HLA 分型解決方案轉換為基於 NGS 的 AlloSeq Tx，因為它消除了透過回流測試來解決模糊結果的需要，並提高了營運效率。

In summary, we had a strong first quarter. We have reset the business and returned to growth. Testing services is gaining momentum as our ever-growing data set of evidence continues to demonstrate the clinical utility and need for our novel non-invasive testing. Traction in our patient and digital solutions is growing, and our products business continues to gain market share. We are effectively managing our bottom line and driving profitable growth by improving efficiencies throughout the organization, enabling us to sustain a healthy cash balance.

總而言之，我們第一季表現強勁。我們已經重新調整業務並恢復成長。隨著我們不斷增長的證據數據集繼續證明我們新型非侵入性測試的臨床實用性和需求，測試服務正在獲得動力。我們的患者和數位解決方案的吸引力正在不斷增長，我們的產品業務不斷獲得市場份額。我們透過提高整個組織的效率來有效管理我們的利潤並推動利潤成長，使我們能夠維持健康的現金餘額。

Given our performance in the first quarter, CareDx is raising its revenue guidance for 2024 to $274 million to $282 million as noted in our press release. Abhishek will provide more detail in his remarks.

鑑於我們第一季的表現，CareDx 將 2024 年的營收指引上調至 2.74 億美元至 2.82 億美元，正如我們在新聞稿中指出的那樣。阿布舍克將在他的演講中提供更多細節。

In conclusion, I want to thank the entire CareDx team for their focus and execution. We have an incredibly talented and inspired organization and we look forward to a strong 2024. With that, I will ask Abhishek to share more details on our first quarter results. Abhishek?

最後，我要感謝整個 CareDx 團隊的專注與執行力。我們擁有一支才華橫溢、充滿靈感的組織，我們期待 2024 年的輝煌。接下來，我將請 Abhishek 分享有關我們第一季業績的更多詳細資訊。阿布舍克？

Thank you, John. In my remarks today, I will discuss our first quarter results before turning to our revised 2024 guidance. Unless otherwise noted, my remarks will focus on non-GAAP results. Please refer to GAAP to non-GAAP reconciliations in our press release today and recent SEC filings for further information.

謝謝你，約翰。在今天的演講中，我將討論我們第一季的業績，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原則的結果上。請參閱我們今天新聞稿中的 GAAP 與非 GAAP 調整表以及最近向 SEC 提交的文件，以了解更多資訊。

Let me start with the key financial highlights. Total revenue for the first quarter was $72 million, up 10% as compared to the fourth quarter of 2023. Testing services revenue was $53.8 million, up 15% quarter-over-quarter. We delivered over 42,000 patient test results, up 6% sequentially, representing the third consecutive quarter of testing services volume growth.

讓我從主要的財務亮點開始。第一季總營收為 7,200 萬美元，比 2023 年第四季成長 10%。測試服務收入為 5,380 萬美元，較上季成長 15%。我們交付了超過 42,000 份患者檢測結果，季增 6%，代表檢測服務量連續第三個季度成長。

Reported patient and digital solutions revenue of $9.6 million, up 12% year-over-year, and Products revenue of $8.6 million, up 25% year-over-year. Improved adjusted EBITDA losses to $1.9 million as compared to $10.3 million loss in Q4 of '23. Finally, we maintained a strong cash position of $216 million at the end of March 2024 and no debt.

報告患者和數位解決方案收入為 960 萬美元，年增 12%，產品收入為 860 萬美元，年增 25%。調整後 EBITDA 虧損從 2023 年第四季的 1,030 萬美元虧損改善至 190 萬美元。最後，截至 2024 年 3 月底，我們維持了 2.16 億美元的強勁現金頭寸，且沒有債務。

Due to the strong overall performance in the first quarter, we are raising our full year 2024 revenue guidance to $274 million to $282 million from our prior guidance of $260 million to $274 million.

由於第一季整體表現強勁，我們將 2024 年全年營收指引從先前的 2.6 億美元至 2.74 億美元上調至 2.74 億美元至 2.82 億美元。

Moving to the details, starting with the testing services. Testing services revenue for the first quarter was $53.8 million, up 15% sequentially. Strong testing services revenue for Q1 was driven by the third consecutive quarter of growth in testing services volumes. Testing services patient results grew to over 42,000 tests, up 6% sequentially, across both abdominal and cardiothoracic testing services. This growth is attributed to our continued success in reestablishing use of AlloSure Kidney and strong performance in heart testing services.

轉向細節，從測試服務開始。第一季測試服務收入為 5,380 萬美元，比上一季成長 15%。第一季強勁的測試服務收入是由測試服務量連續第三個季度成長所推動的。腹部和心胸檢測服務的檢測服務患者結果增加至 42,000 多項檢測，較上季增加 6%。這一增長歸功於我們在重新建立 AlloSure Kidney 的使用方面的持續成功以及在心臟測試服務方面的強勁表現。

In addition, testing services revenue benefited from continued revenue cycle management initiatives, including pursuing unpaid claims from tests delivered in the prior quarters. These efforts added approximately $3.7 million in revenue in the first quarter. We'll continue to aggressively pursue unpaid historical claims.

此外，測試服務收入受益於持續的收入周期管理舉措，包括追究前幾季交付的測試的未付索賠。這些努力在第一季增加了約 370 萬美元的收入。我們將繼續積極追查未支付的歷史索賠。

Our non-GAAP testing services adjusted gross margin was 76% in the first quarter compared to 72% in the fourth quarter of 2023. Adjusted for the $3.7 million revenue, as discussed earlier, testing services gross margin stayed healthy at 74%. Our lab operations team continues to drive efficiencies and manage expenses well with initiative focus on improving logistics and sample processing costs.

我們的非 GAAP 測試服務調整後毛利率第一季為 76%，而 2023 年第四季為 72%。如前所述，根據 370 萬美元的收入進行調整後，測試服務毛利率保持在 74% 的健康水準。我們的實驗室營運團隊持續提高效率並管理好費用，主動專注於改善物流和樣品處理成本。

Now turning to the other businesses. Our patient and digital solutions business reported revenue of $9.6 million in the first quarter, up 12% year-over-year. Strong top line results were driven by core digital offerings. Our patient and digital solutions business non-GAAP gross margin for the first quarter was 34% compared to 31% in the first quarter of 2023.

現在轉向其他業務。我們的患者和數位解決方案業務第一季營收為 960 萬美元，年增 12%。強勁的營收業績是由核心數位產品推動的。我們第一季的患者和數位解決方案業務非 GAAP 毛利率為 34%，而 2023 年第一季為 31%。

Our products business recorded revenue of $8.6 million in the first quarter, up 25% year-over-year. Growth in the Products business was once again driven by NGS-based care solutions for HLA labs. Our non-GAAP gross margin for our products business was 46% in the first quarter, down from 52% from the first quarter of 2023. We have completed the end-of-life build for one of our products and ramped up manufacturing capabilities with our contract manufacturers in the U.S. and Europe. We are on track to substantially close our manufacturing operations in Fremantle, Australia as part of our site consolidation initiative. We expect these initiatives will help us improve the gross margin of this business to the mid-50s on a sustainable basis.

我們的產品業務第一季營收為 860 萬美元，年增 25%。產品業務的成長再次受到 HLA 實驗室基於 NGS 的護理解決方案的推動。我們的產品業務第一季的非 GAAP 毛利率為 46%，低於 2023 年第一季的 52%。我們已經完成了其中一款產品的報廢構建，並與美國和歐洲的合約製造商一起提高了製造能力。作為工廠整合計劃的一部分，我們預計將大幅關閉在澳洲弗里曼特爾的製造業務。我們預計這些舉措將有助於我們可持續地將這項業務的毛利率提高到 50 多歲。

Moving down the P&L. Non-GAAP operating expenses for the first quarter were $52.3 million, down approximately $1.9 million as compared to the last quarter and down over $9 million as compared to the first quarter of 2023. We have made substantial progress in managing our expenses while ensuring that we continue to invest in areas that will help drive growth.

損益表向下移動。第一季非 GAAP 營運費用為 5,230 萬美元，比上一季減少約 190 萬美元，比 2023 年第一季減少超過 900 萬美元。我們在管理開支方面取得了實質進展，同時確保我們繼續投資於有助於推動成長的領域。

Adjusted EBITDA for the first quarter of 2024 was a loss of $1.9 million compared to an adjusted EBITDA loss of $10.3 million in the fourth quarter of 2023 and a loss of $6.4 million in the first quarter of '23. The first quarter was positively impacted by $3.7 million in revenue as discussed earlier. We are pleased with the progress that we're making on driving profitable growth.

2024 年第一季調整後 EBITDA 虧損 190 萬美元，而 2023 年第四季調整後 EBITDA 虧損 1,030 萬美元，2023 年第一季調整後 EBITDA 虧損 640 萬美元。如前所述，第一季收入受到 370 萬美元的正面影響。我們對推動獲利成長所取得的進展感到高興。

Turning to cash. We maintained a strong balance sheet of $216 million in cash, cash equivalents and marketable securities, with no debt. Cash used in operations for the first quarter was $15.3 million as compared to $8.4 million last quarter and a positive cash from operations of $0.7 million a year ago. Cash usage in the first quarter is seasonally higher due to annual bonus payouts. Based on our current cash position and anticipated cash usage in operations, we continue to believe that we do not need to raise cash in the foreseeable future.

轉向現金。我們維持 2.16 億美元現金、現金等價物和有價證券的強勁資產負債表，沒有任何債務。第一季營運中使用的現金為 1,530 萬美元，而上季為 840 萬美元，去年同期營運中使用的現金為 70 萬美元。由於年度獎金支付，第一季的現金使用量季節性較高。根據我們目前的現金狀況和預期營運中的現金使用情況，我們仍然認為在可預見的未來我們不需要籌集現金。

Turning to guidance. Based on the healthy performance across all businesses in the first quarter of 2024, we are now raising the full year revenue guidance to $274 million to $282 million. The midpoint of our 2024 guidance assumes low double-digit testing services revenue growth based on annualized actual testing services revenue for the fourth quarter of '23. No change in medical coverage, no incremental revenue assumed from new private payer coverage decisions or onetime benefits associated with collections, and high single-digit growth year-over-year for our products business and mid-single-digit growth year-over-year for our patient and digital solutions businesses. We expect our gross margin to be at the high end of our previously reported range of approximately 63% to 65%, driven by the improved testing services gross margin.

轉向指導。基於 2024 年第一季所有業務的健康表現，我們現將全年營收指引提高至 2.74 億美元至 2.82 億美元。我們的 2024 年指引的中點假設是基於 2023 年第四季的年化實際測試服務收入實現低兩位數的測試服務收入成長。醫療保險沒有變化，新的私人付款人承保決策或與託收相關的一次性福利不會帶來增量收入，我們的產品業務同比高個位數增長，同比中個位數增長適用於我們的患者和數位解決方案業務。在測試服務毛利率改善的推動下，我們預計我們的毛利率將達到先前報告的約 63% 至 65% 範圍的高端。

Due to improved revenue expectation and gross margin, we expect our adjusted EBITDA losses for the full year '24 to be between $14 million to $24 million as compared to the previously guided $20 million to $30 million.

由於收入預期和毛利率的改善，我們預計 24 年全年調整後的 EBITDA 損失將在 1,400 萬美元至 2,400 萬美元之間，而先前指導的為 2,000 萬美元至 3,000 萬美元。

I would like to thank the entire CareDx team for their focus and delivery in executing against our plan for 2024. Before we open the line for questions, I would like to turn the call over to John to deliver closing remarks.

我要感謝整個 CareDx 團隊在執行我們 2024 年計畫時的專注和交付。在我們開始提問之前，我想將電話轉接給約翰發表結束語。

Thank you, Abhishek. As we conclude our prepared remarks, I want to again express how proud I am to be a member of the CareDx team. Our strong results this quarter underscore the value of our solutions and our commitment to serving patients. And now I would like to ask the operator to open the line for any questions.

謝謝你，阿布舍克。在我們結束準備好的演講時，我想再次表達我作為 CareDx 團隊的一員是多麼自豪。我們本季的強勁業績凸顯了我們解決方案的價值以及我們對服務患者的承諾。現在我想請接線生為我解答任何問題。

(Operator Instructions)

（操作員說明）

Bill Bonello, Craig-Hallum Capital Group.

比爾·博內羅，克雷格-哈勒姆資本集團。

Good morning, guys. Nice quarter. So just first, just a housekeeping item. It's interesting that you called out the prior period collections. Just thinking about this, as you work on revenue capture, won't prior period revenue become kind of a normal thing for a while? Or is this just a lot bigger than what you might expect in a typical quarter?

早上好傢伙。不錯的季度。所以首先，只是一個家務用品。有趣的是，你提到了前期的收藏。試想一下，當您致力於收入獲取時，前期收入不會在一段時間內變得正常嗎？或者這是否比您在典型季度中的預期要大得多？

Thanks, Bill. Appreciate the question. I'm going to ask Abhishek to take this one.

謝謝，比爾。感謝這個問題。我要請阿布舍克拿走這個。

Yeah. Thanks for the question, Bill. And you're right that we continue to pursue some of those unpaid claims from the prior period test, Bill. And we would want to provide enough color so that we can model these appropriately. But going back to your question, once we have had the success in negotiating these with these payers, it definitely becomes a tailwind as we kind of look at this from the go-forward basis.

是的。謝謝你的提問，比爾。你是對的，我們將繼續追查前期測試中的一些未付索賠，比爾。我們希望提供足夠的顏色，以便我們可以適當地對它們進行建模。但回到你的問題，一旦我們與這些付款人成功談判這些問題，它肯定會成為一種順風，因為我們從未來的角度來看這一點。

Okay. Thanks. And then just the second thing is just the -- what -- go ahead.

好的。謝謝。然後第二件事就是──什麼──繼續。

Yeah. Bill, I was just going to add. I think in Q4, we also had onetime prior period collections, and we see this amount of prior period potential revenue declining over time as we negotiate through these onetime events. So we call it out here because we don't anticipate it to continue to be a substantial sum into perpetuity. We do think this balance will draw down, so we will continue to call that out when it occurs. But we're not providing those onetime events as a part of our go-forward guidance.

是的。比爾，我只是想補充一下。我認為在第四季度，我們也有一次性的前期收款，當我們透過這些一次性事件進行談判時，我們看到前期潛在收入隨著時間的推移而下降。所以我們在這裡指出它是因為我們預計它不會永遠成為一筆大筆資金。我們確實認為這種平衡將會減少，因此當這種情況發生時我們將繼續指出這一點。但我們不會將這些一次性事件作為我們未來指導的一部分。

Okay. That makes sense. But when I think about it -- sorry to just beat this one. But when I think about it, so it is a prior period, I get it. It's something you weren't paid. But does it also speak a little bit to run rate? In other words, that's $3.5 million that you never were getting paid in the past that presumably looking forward, you will be getting paid? Or should we not think about it like that?

好的。這就說得通了。但當我想到這一點時——很抱歉剛剛擊敗了這個。但當我想到這一點時，所以這是一個前期，我明白了。這是你沒有得到報酬的東西。但這也說明了運行率嗎？換句話說，這 350 萬美元是你過去從未得到過的，但未來你會得到報酬嗎？或者說我們不應該這樣想嗎？

That's what we're hoping to occur, Bill. And so we would anticipate that on a go-forward basis, we'd see improvement in ASPs as a result of working through these processes with individual payers.

這就是我們希望發生的事情，比爾。因此，我們預計，在未來的基礎上，由於與個人付款人一起完成這些流程，我們將看到平均售價的增加。

Okay. Thank you. And then the other thing was just can you talk about what you're seeing in terms of physician behavior on the kidney surveillance testing side? Has it ticked back up since CMS put out that letter at the end of February? Or what's kind of the situation there?

好的。謝謝。然後另一件事是您能談談您在腎臟監測測試方面的醫生行為方面所看到的情況嗎？自 CMS 在二月底發出那封信以來，它是否有所回升？或者說那裡的情況怎麼樣？

Yes, that's a great question. Thanks, Bill. And as we stated in our prepared remarks, our volumes grew across all 3 segments of the business, heart, kidney, and lung. We have implemented the requirements that CMS has put in place or that the MACs have put in place for payment of testing, and we continue to see our volumes grow as a result of that. We don't think that is going to change substantially going forward other than to acknowledge that the agency has stated that they intend to continue to provide access to monitoring assays for transplant rejection, and we'll continue to support that and communicate it in the field with clinicians as they adopt these products going forward.

是的，這是一個很好的問題。謝謝，比爾。正如我們在準備好的發言中所述，我們的心臟、腎臟和肺臟三個業務領域的銷量均有所增長。我們已經實施了 CMS 或 MAC 制定的支付測試費用的要求，並且我們的數量因此不斷增長。我們認為，除了承認該機構已表示他們打算繼續提供移植排斥監測檢測之外，這種情況不會發生實質性改變，我們將繼續支持這一點並在與臨床醫生一起採用這些產品。

Matt Sykes, Goldman Sachs.

馬特·賽克斯，高盛。

Hey, guys, congrats on the quarter. This is Prashant Kota on for Matt. So with the billing article revisions last year having impacted your product mix from being majority kidney to majority heart and lung for both volumes and revenues, do you anticipate that trend continuing in the near term? And how will that impact ASPs?

嘿，夥計們，恭喜這個季度。我是普拉尚特·科塔 (Prashant Kota) 替補馬特 (Matt)。因此，由於去年的計費文章修訂影響了您的產品組合，從銷售和收入來看，從以腎臟為主變為以心臟和肺為主，您預計這種趨勢在短期內會持續下去嗎？這將如何影響 ASP？

Thanks for the question. I'm going to ask Abhishek to take this one.

謝謝你的提問。我要請阿布舍克拿走這個。

Prashant, yes, we have called out in our Investor Day meeting that cardiothoracic is now about 60% of our volume. And given the fact that we are seeing that the heart franchise is kind of growing pretty -- at a pretty decent pace, we believe that this trend will continue. Now one quarter will not provide us if there is a permanent shift further from here, but I would expect this to continue.

Prashant，是的，我們在投資者日會議上指出，心胸外科目前約占我們業務量的 60%。鑑於我們看到心臟特許經營權正在以相當不錯的速度增長，我們相信這種趨勢將持續下去。現在，如果有永久性的偏離這裡，四分之一將無法為我們提供，但我預計這種情況會持續下去。

Got it. And then can you speak to any synergies that may exist upstream of organ transplant surveillance? For example, within the organ transplant delivery network involving companies such as TransMedics?

知道了。那麼您能談談器官移植監測上游可能存在的任何協同作用嗎？例如，在涉及 TransMedics 等公司的器官移植交付網路中？

Yes. Thanks. I'm going to ask Alex Johnson, our President of testing services, to take this question.

是的。謝謝。我將請我們的測試服務總裁 Alex Johnson 回答這個問題。

Yes, thanks. We acquired a company called MediGO a couple of quarters ago. And there's a lot of work going on to increase the utilization and consequently, organ supply upstream. And I think that's where we're going with this. And there's quite a bit of excitement around this space. And I think we've certainly seen this in the increase in heart transplant. Certainly, that's a growth area that is outpacing other areas of the market for transplant. And I think these areas are places that we can continue to play in. And we have digital tools as well as products. Our product business primarily is pre-transplant.

對了謝謝。幾季前我們收購了一家名為 MediGO 的公司。為了提高利用率，從而提高上游器官供應，正在進行大量工作。我認為這就是我們的目標。這個領域有很多令人興奮的地方。我認為我們在心臟移植的增加中肯定看到了這一點。當然，這是一個成長速度超過移植市場其他領域的領域。我認為這些領域是我們可以繼續發揮作用的地方。我們擁有數位工具和產品。我們的產品業務主要是移植前產品。

And so we're able to think about ways to incorporate our tools upstream as well, and that utilization increase as well as better outcomes really completes the whole ecosystem for our patients and the clinicians. So it's a great question. We're very well positioned to play there as well as in the entire transplant journey.

因此，我們能夠考慮如何將我們的工具整合到上游，並且利用率的增加以及更好的結果真正為我們的患者和臨床醫生完善了整個生態系統。所以這是一個很好的問題。我們處於非常有利的位置，可以在那裡以及整個移植之旅中發揮作用。

Got it. And then just lastly, I would love to get your sense high level of key takeaways from that proposed IOTA Model from CMS. I haven't actually read through the document fully, but would love to get details behind the incentive plan that it mentions and its impact on.

知道了。最後，我很樂意讓您從 CMS 提出的 IOTA 模型中獲得高水準的關鍵要點。我實際上還沒有完全閱讀該文件，但很想了解其中提到的激勵計劃背後的詳細資訊及其影響。

Yeah, this is Alex again. I can take this. I did read all 300 or so pages or at least tried to get through it last night. We're still going through it. I think the headline here is that there's a clear need to continue to increase the organ supply and increasing utilization and reducing discards and improving outcomes. I mean these are all things that are going to help patients.

是的，這又是亞歷克斯。我可以接受這個。我確實讀了全部 300 頁左右，或者至少昨晚嘗試讀完它。我們仍在經歷它。我認為這裡的標題是，顯然需要繼續增加器官供應、提高利用率、減少丟棄和改善結果。我的意思是這些都是對病人有幫助的事情。

And so when you look at it, you've already got a nice upswing on -- just from a market perspective, kidney transplants have been growing nicely. I think they grew year-over-year in Q1 about 6%. Heart has continued to grow, actually seemingly above that. Last year, I think heart was 11% from an annualized growth basis. And so you've got some significant upsides here. We'll see where this goes. This is proposed. And we're certainly monitoring and we'll read closely, and we'll see how these value-based care initiatives continue to drive the market forward.

因此，當你看到它時，你已經看到了一個很好的上升趨勢——僅從市場角度來看，腎臟移植一直在良好成長。我認為第一季同比增長約 6%。心還在繼續成長，實際上看起來已經超越了這個範圍。去年，我認為 Heart 的年增長率為 11%。所以你在這裡有一些顯著的優勢。我們會看看這會發生什麼。這是提議的。我們當然會進行監控，我們會仔細閱讀，我們將看到這些基於價值的護理計劃如何繼續推動市場向前發展。

And we are extremely, I think, well positioned to play there because that's exactly where our products can best be positioned, right? It's not just more transplant. It's higher-risk organs, it's better utilization of these organs. And what do you need when you have higher-risk organs? You need to watch them more carefully. You need to use digital tools. You need to use products like AlloSure to help monitor these patients. And so this is something where we're extremely well positioned, and we're really looking forward to seeing where this goes.

我認為，我們非常有能力在那裡發揮作用，因為這正是我們的產品最適合定位的地方，對吧？這不僅僅是更多的移植。它是風險較高的器官，可以更好地利用這些器官。當您擁有高風險器官時，您需要什麼？你需要更仔細地觀察它們。您需要使用數位工具。您需要使用 AlloSure 等產品來幫助監測這些患者。因此，我們在這方面處於非常有利的位置，我們真的很期待看到它的發展方向。

Mason Carrico, Stephens

梅森·卡里科、史蒂芬斯

Hey, guys. Thanks fr the questions here. In terms of the guidance increase for testing services, so $4 million or so, $3 million to $4 million or whatever the cash collections were, this quarter is benefiting there. But if you could, could you walk back through what the assumptions were in the testing services guide? Really, what I'm looking for here is this, are you incorporating now a higher growth rate in volumes? Are you seeing anything that has maybe accelerated adoption trends above your initial assumptions? So just any color in that makeup again.

大家好。謝謝這裡的提問。就測試服務的指導成長而言，約 400 萬美元、300 萬至 400 萬美元或無論現金收入是多少，本季都會從中受益。但如果可以的話，您能回顧一下測試服務指南中的假設嗎？真的，我在這裡尋找的是這個，你們現在的銷售成長率是否更高？您是否看到任何可能加速採用趨勢超出您最初假設的事情？所以，妝容中的任何顏色都可以。

Yes. Thanks, Mason. I'm going to ask Abhishek to walk through those assumptions for you.

是的。謝謝，梅森。我將請 Abhishek 為您解釋這些假設。

Yeah. So Mason, yes, based on the volume growth that we saw in the Q1, we have now raised the full year testing services volume growth expectation to high single-digit as compared to the mid single-digit that we were assuming previously. So that's the first change at the midpoint of our guide.

是的。所以梅森，是的，根據我們在第一季看到的數量增長，我們現在將全年測試服務數量增長預期提高到高個位數，而我們之前假設的中等個位數。這是我們指南中的第一個變化。

And the second piece is the products business that we were assuming to be growing at a high single-digit -- that we were assuming to be growing at a mid single-digit, we are now assuming that business is going to grow in a high single-digit. So we're making a couple of changes based on the results that we have seen in the first quarter. And now at the midpoint of our new guide on a adjusted '23 revenue basis, Mason, we have increased the overall revenue growth from a 4% year-over-year to 8% year-over-year. So almost doubling the growth rate there.

第二部分是我們假設以高個位數成長的產品業務－我們原本假設以中個位數成長，現在我們假設業務將以高個位數成長個位數。因此，我們根據第一季的結果進行了一些更改。現在，在我們調整後的 23 年收入基礎上的新指南的中點，Mason，我們已將整體收入增長率從同比 4% 提高到同比 8%。所以那裡的成長率幾乎翻了一番。

Got it. The part I missed, the volume growth, is what you're guiding. You've got it. That makes sense. And appreciate the detailed color on HeartCare. Given the opportunity and potential for that offering, could you just give us a sense where utilization of HeartCare stands today? What portion -- and I know you may not want to get too specific here. But as we kind of look at your heart volumes, how much is coming from HeartCare today versus AlloMap or AlloSure Heart standalone?

知道了。我錯過的部分，即銷量成長，正是您所指導的。你已經明白了。這就說得通了。並欣賞 HeartCare 上的詳細顏色。鑑於該產品的機會和潛力，您能否讓我們了解一下 HeartCare 目前的使用情況？什麼部分——我知道你可能不想在這裡說得太具體。但當我們查看您的心臟體積時，與 AlloMap 或 AlloSure Heart 獨立版相比，今天的 HeartCare 帶來了多少收入？

Yeah, Mason. So again, I think that's like the next level of details. We generally do not provide the volumes at the organ level. But having said that, in the HeartCare, there's no change from the commercial payer standpoint, as you know. And on the HeartCare also from the Medicare, now we have the coverage for the first year. And the second year is the piece that we are working towards, seeing as to how do we get that coverage back.

是的，梅森。再說一次，我認為這就像下一個層次的細節。我們通常不提供器官級別的體積。但話雖如此，如您所知，從商業付款人的角度來看，HeartCare 並沒有任何變化。醫療保險 (Medicare) 的 HeartCare 也提供了第一年的承保範圍。第二年是我們正在努力的方向，看看我們如何恢復覆蓋範圍。

There are no further questions in the queue at this time. This does conclude today's program. Thank you for your participation. You may disconnect at any time.

目前隊列中沒有其他問題。今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。