CareDx Inc (CDNA) 2023 Q3 法說會逐字稿

Good day, everyone, and welcome to today's CareDx Inc. Third Quarter 2023 Earnings Conference Call. (Operator Instructions) Please note this call is being recorded. (Operator Instructions) It is now my pleasure to turn the call over to Greg Chodaczek, Managing Director. Please go ahead.

大家好，歡迎參加今天的 CareDx Inc. 2023 年第三季財報電話會議。 （操作員說明）請注意此通話正在錄音。 （操作員指示）現在我很高興將電話轉給董事總經理 Greg Chodaczek。請繼續。

Good afternoon, and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ended September 30, 2023. The release is currently available on the company's website at www.caredx.com. Joining the call today is Alex Johnson, President of CareDx's Patient and Testing Services, Abhishek Jain, Chief Financial Officer; and Robert Woodward, Chief Scientific Officer. Also joining on the call today is Michael Goldberg, Chairperson of the Board.

下午好，感謝您今天加入我們。今天早些時候，CareDx 發布了截至 2023 年 9 月 30 日的季度財務業績。該新聞稿目前可在公司網站 www.caredx.com 上取得。今天加入電話會議的有 CareDx 患者和檢測服務總裁 Alex Johnson、財務長 Abhishek Jain；和首席科學官羅伯特·伍德沃德。董事會主席 Michael Goldberg 也參加了今天的電話會議。

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 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.

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，這些聲明是根據美國《私人證券訴訟改革法案》的安全港條款制定的。1995 年。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。

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. 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 of descriptions of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission.

所有前瞻性陳述，包括但不限於我們對歷史營運趨勢的審查、對核保決策、定價和投保事宜的預期，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。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描述列表，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 8, 2023. 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. This call 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 with the SEC.

本次電話會議中提供的資訊僅針對今天（2023 年11 月8 日）的直播。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，無論是因為新資訊、未來事件或其他。此次電話會議也將討論某些不依照公認會計原則計算的財務指標。與最直接可比較的 GAAP 財務指標的調整可以在今天向 SEC 發布的收益報告中找到。

I will now turn the call over to Alex.

我現在將把電話轉給亞歷克斯。

Thank you, Greg. Good afternoon, everyone, and thank you for joining today's call. I'm Alex Johnson, President of CareDx's Patient and Testing Services, a member of the newly formed office of the CEO, along with Michael Goldberg, Chairperson of the Board; and Abhishek Jain, CFO. The I'd like to begin today's call by briefly covering the CEO transition we announced last week. Michael, Abhishek and I are aligned on the importance of executing against CareDx's strategic priorities and increasing shareholder returns, while the Board conducts its search for a new CEO. We have strong confidence in our leadership team and in the entire CareDx team to move the company forward.

謝謝你，格雷格。大家下午好，感謝您參加今天的電話會議。我是 Alex Johnson，CareDx 病患和檢測服務部總裁，是新成立的執行長辦公室的成員，我是董事會主席 Michael Goldberg；和財務長 Abhishek Jain。我想在今天的電話會議開始時簡要介紹我們上周宣布的執行長換屆事宜。在董事會尋找新執行長的同時，Michael、Abhishek 和我在執行 CareDx 策略重點和增加股東回報的重要性上達成一致。我們對我們的領導團隊和整個 CareDx 團隊推動公司向前發展充滿信心。

For those of you whom I've not yet met, I have managed CareDx's largest business, the Testing Services business for the past 2 years. Prior to that, I had have responsibility for our lab products business as well as for business development. I have been incredibly fortunate to have worked with Michael on CareDx's IPO nearly a decade ago and with Abhishek for the past 2 years. I've also been privileged to work with Peter Maag, who many of you know as our former longtime CEO and current Board member for the better part of 15 years, dating from our time together at Novartis. On behalf of CareDx, we thank Reg for his contributions to advanced transplant care during his tenure. We have a strong foundation for future growth, and we wish him the very best.

對於那些我尚未見過的人來說，過去兩年我一直管理著 CareDx 最大的業務，也就是測試服務業務。在此之前，我負責我們的實驗室產品業務以及業務開發。我非常幸運能夠在近十年前與 Michael 一起參與 CareDx 的 IPO，並在過去兩年與 Abhishek 合作。我也很榮幸能與 Peter Maag 共事，你們很多人都知道他是我們的前長期執行長和現任董事會成員，從我們在諾華一起工作起就已經工作了 15 年。我們代表 CareDx，感謝 Reg 在任職期間對先進移植護理的貢獻。我們為未來的發展奠定了堅實的基礎，我們祝福他一切順利。

Moving on to our third quarter performance. Today, I'm going to discuss our third quarter performance and results, discuss our decision to raise full year 2023 revenue guidance and finally, I will provide additional context around the transplant market environment and our patient advocacy efforts. In Q3, CareDx reported revenue of $67.2 million, an increase of 7% as compared to normalized second quarter 2023 revenue. Normalized Q2 2023 revenue results excludes the previously discussed financial impact of $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in Q2 revenue. Our Q3 revenue for testing services came in at $47.8 million, growth of 5% compared to the normalized second quarter of 2023. Our patient testing services result grew 2% quarter-over-quarter to 38,400. After the period of uncertainty in the last few quarters, we now see a baseline being set in the testing services business as patient testing services volumes appear to have stabilized. We continue to be well placed in the transplant market, which is growing and is expected to continue to grow.

繼續我們第三季的業績。今天，我將討論我們第三季度的業績和結果，討論我們提高 2023 年全年收入指導的決定，最後，我將提供有關移植市場環境和我們的患者宣傳工作的更多背景信息。第三季度，CareDx 報告營收為 6,720 萬美元，比 2023 年第二季正常營收成長 7%。正常化的 2023 年第二季度收入結果不包括先前討論的與 Medicare 索賠帳單相關的 780 萬美元財務影響，這些影響從 2023 年第一季度保留並在第二季度收入中確認。我們第三季的測試服務收入為 4,780 萬美元，與 2023 年第二季正常化水準相比成長 5%。我們的病患測試服務結果較上季成長 2%，達到 38,400 人。經過過去幾季的不確定時期後，我們現在看到測試服務業務已經設定了基線，因為患者測試服務量似乎已經穩定。我們在移植市場中繼續處於有利地位，該市場正在成長並且預計將繼續成長。

Next, our digital transplant solutions business grew 33% year-over-year to $9.9 million driven by organic growth from our recent acquisitions. Some of our earlier acquisitions are beginning to scale nicely, helping us to drive both operating leverage and strengthening our moat. Our lab products business realized revenue of $9.5 million with year-over-year growth of 33%, driven by the success of our NGS-based portfolio. We are pleased with our improved performance, which is a result of an enhanced focus on driving revenue and improved efficiency in lab products, which has been an ongoing effort. We are pleased with our continued progress to actively reduce our overall expense base, which has helped mitigate the billing article impact lower full year revenue on our results. We will continue to look for ways to be more effective and efficient.

接下來，在我們最近收購的有機成長的推動下，我們的數位移植解決方案業務年增 33% 至 990 萬美元。我們早期的一些收購開始很好地擴大規模，幫助我們提高營運槓桿並加強我們的護城河。在我們基於 NGS 的產品組合的成功推動下，我們的實驗室產品業務營收 950 萬美元，年增 33%。我們對業績的提高感到滿意，這是我們不斷努力提高實驗室產品收入和效率的結果。我們對積極減少整體費用基礎的持續進展感到高興，這有助於減輕計費文章對我們業績造成的全年收入下降的影響。我們將繼續尋找更有效和更有效率的方法。

Our adjusted EBITDA loss was $10.9 million in the current quarter as compared with normalized adjusted EBITDA loss of $18.1 million in Q2. Our goal is to be operating cash flow and adjusted EBITDA positive, and we are pleased to show demonstrable progress on this metric. We have confidence in our outlook going forward. As announced last week, we are raising guidance and now expect CareDx's full year 2023 revenue to be in the range of $274 million to $278 million. Abhishek will provide additional details during his remarks. In light of our strong cash position and belief that our stock is currently undervalued, we will continue to opportunistically pursue stock repurchases as part of our previously announced stock repurchase program.

本季調整後 EBITDA 損失為 1,090 萬美元，而第二季正常調整後 EBITDA 損失為 1,810 萬美元。我們的目標是實現營運現金流量和調整後 EBITDA 為正值，我們很高興在這項指標上取得明顯進展。我們對未來的前景充滿信心。正如上周宣布的那樣，我們正在提高指導，目前預計 CareDx 2023 年全年收入將在 2.74 億美元至 2.78 億美元之間。阿布舍克將在講話中提供更多細節。鑑於我們強大的現金狀況以及我們的股票目前被低估的信念，我們將繼續機會主義地進行股票回購，作為我們先前宣布的股票回購計劃的一部分。

Next, I'll discuss our reimbursement coverage. In Q3, 2 previously announced catalysts came to fruition. We received Medicare coverage for AlloSure Lung and for HeartCare. Since its launch in 2021, AlloSure Lung has become increasingly valuable for lung transplant patient care. HeartCare multimodality coverage was approved for surveillance. This has established a path for multimodality reimbursement that can be generalizable for other testing modalities in our portfolio such as AlloMap Kidney and UroMap. We continue to focus on increasing commercial payer coverage. For example, 1 national plan and 3 regional plans expanded coverage for AlloMap Heart to start at 6 months as compared to 1 year. We also gained coverage for 2 new regional plans for AlloSure Kidney.

接下來，我將討論我們的報銷範圍。第三季度，先前宣布的 2 個催化劑取得了成果。我們獲得了 AlloSure Lung 和 HeartCare 的 Medicare 承保。自 2021 年推出以來，AlloSure Lung 對於肺移植患者的照護變得越來越有價值。 HeartCare 多模式保險已獲批准用於監測。這建立了一條多模式報銷路徑，可推廣到我們產品組合中的其他測試模式，例如 AlloMap Kidney 和 UroMap。我們繼續致力於增加商業付款人的覆蓋範圍。例如，1 個國家計劃和 3 個地區計劃將 AlloMap Heart 的覆蓋範圍從 1 年擴大到 6 個月開始。我們也涵蓋了 AlloSure Kidney 的 2 個新區域計畫。

Moving to catalyst. When we have talked about catalysts in the past, we have highlighted our robust pipeline of clinical testing solutions, which is exciting, and we will continue to cover in future calls. Today, I want to highlight progress on a slightly different catalyst, one, which can facilitate greater payer coverage for AlloSure Kidney, and that is [KAOR]. KAOR, our kidney allograft outcomes registry has now completed the last clinical visits in Q3, and we will next move to data analysis. We anticipate a publication in 2024. KAOR has the potential to provide additional insights of payers, including Medicare, with respect to the clinical utility of AlloSure Kidney, including surveillance use in a wide variety of kidney patients. Our priority is to be good stewards of capital in this new environment. To invest in our strongest businesses and pipeline products that help us to deliver on our mission to bring innovation to transplant patient care while also creating the most value for investors in the short to midterm.

轉向催化劑。當我們過去談論催化劑時，我們強調了我們強大的臨床測試解決方案管道，這令人興奮，我們將在未來的電話會議中繼續討論。今天，我想強調一種略有不同的催化劑的進展，它可以促進 AlloSure Kidney 更大的付款人覆蓋範圍，那就是 [KAOR]。 KAOR，我們的同種異體腎臟移植結果登記處現已完成第三季度的最後一次臨床訪問，接下來我們將進行數據分析。我們預計將於 2024 年發布。KAOR 有可能為包括 Medicare 在內的付款人提供有關 AlloSure Kidney 臨床效用的更多見解，包括在各種腎臟患者中的監測使用。我們的首要任務是在新環境中做好資本管家。投資我們最強大的業務和管道產品，幫助我們實現為移植患者護理帶來創新的使命，同時在中短期內為投資者創造最大價值。

Our strategy has not changed. We have nearly a quarter century commitment to improving transplant patient outcomes, extending long-term allograft survival. And this will continue. We are confident that patients and investors can both benefit from the innovation and commercialization expertise of the CareDx team.

我們的策略沒有改變。近四分之一個世紀以來，我們一直致力於改善移植患者的治療效果，並延長同種異體移植物的長期存活率。這種情況還會持續下去。我們相信，患者和投資者都能從 CareDx 團隊的創新和商業化專業知識中受益。

Next, I want to address the conversations around GLP-1 drugs and their potential impact on kidney transplant volumes. There are about 550,000 dialysis patients in the U.S. and only about 25,000 kidneys transplants per year, with organ supply continuing to be the limiting factor. While GLP drugs have the potential to delay or may eliminate the need for dialysis in some patients, there's also the potential to help increase the number of dialysis patients eligible for a kidney transplant by improving their overall health or reducing their BMI. With respect to supply, it may be useful to note the potential impact of GLP drugs on the living donor pool, which is a major driver of kidney transplant volumes. Living donation volumes have the potential to increase beyond current trend lines as potential donors become healthier due to GLP-1 and feel more confident to donate their kidney.

接下來，我想談談有關 GLP-1 藥物及其對腎臟移植量的潛在影響的討論。美國約有 55 萬名透析患者，每年僅進行約 2.5 萬例腎臟移植，器官供應仍是限制因素。雖然 GLP 藥物有可能延遲或可能消除某些患者的透析需求，但也有可能透過改善整體健康狀況或降低體重指數來幫助增加適合腎臟移植的透析患者數量。在供應方面，注意到 GLP 藥物對活體捐贈者庫的潛在影響可能會有所幫助，而活體捐贈者庫是腎臟移植量的主要驅動因素。隨著潛在捐贈者因 GLP-1 變得更健康並且更有信心捐贈腎臟，活體捐贈量有可能超越當前趨勢線。

Before I turn the call over to Abhishek, I would like to touch on our advocacy efforts on behalf of transplant patients. We have been actively engaged in discussions with Medicare and HHS as well as helping to support legislative action and advocacy efforts to restore full patient access for Medicare beneficiaries. We have made good progress to date. On August 15, a bipartisan group of 14 members of Congress wrote to CMS administrator, Chiquita Brooks-LaSure, to challenge CMS to reconsider these new limits on access to critical molecular tests that benefit transplant patients. In September, the Wall Street Journal Editorial Board published 3 editorials decrying the rollback in coverage for Medicare patients. Then in mid-September, MolDx held open meetings for public comment on the proposed LCD. CareDx was proud to have presented at both the MolDx Palmetto and the Noridian open meetings on molecular testing for allograft rejection. We and the broad transplant community will continue to fight for access to transplant innovation.

在將電話轉給 Abhishek 之前，我想談談我們代表移植患者所做的宣傳工作。我們一直積極參與與 Medicare 和 HHS 的討論，並幫助支持立法行動和宣傳工作，以恢復 Medicare 受益人的全面患者服務。到目前為止，我們已經取得了良好的進展。 8 月 15 日，由 14 名國會議員組成的兩黨團體寫信給 CMS 管理員 Chiquita Brooks-LaSure，要求 CMS 重新考慮這些對移植患者有利的關鍵分子檢測的新限制。 9 月，《華爾街日報》編輯委員會發表了 3 篇社論，譴責醫療保險患者承保範圍的縮減。隨後在 9 月中旬，MolDx 召開了公開會議，徵求公眾對擬議 LCD 的意見。 CareDx 很榮幸能夠在 MolDx Palmetto 和 Noridian 公開會議上發表有關同種異體移植排斥的分子測試的報告。我們和廣大移植界將繼續為獲得移植創新而奮鬥。

With that, I'd like to turn the call over to Abhishek to discuss additional details on our quarterly results and outlook, and we'll go from there to Q&A. Abhishek?

說到這裡，我想將電話轉給 Abhishek，討論有關我們季度業績和前景的更多細節，然後我們將進行問答。阿布舍克？

Thank you, Alex. In my remarks today, I will provide some additional detail on quarterly financial results, residual impact of the billing vertical revisions on our financials and close with an update on guidance. Unless otherwise noted, my remarks will focus on non-GAAP results. Also, my comparisons with Q2 '23 results will exclude the financial impact of $7.8 million related to Medicare tests that were held over from the first quarter of '23 and recognized in Q2 revenue and refer to as normalized second quarter. Please refer to GAAP to non-GAAP reconciliations for detailed information.

謝謝你，亞歷克斯。在今天的演講中，我將提供有關季度財務業績、計費垂直修訂對我們財務的剩餘影響的一些額外細節，並以最新指導意見作為結束。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。此外，我與23 年第二季結果的比較將排除與Medicare 測試相關的780 萬美元的財務影響，這些影響從23 年第一季開始保留並在第二季度收入中確認，並稱為標準化第二季。有關詳細信息，請參閱 GAAP 與非 GAAP 調節表。

Key highlights of Q3 results were: number one, reported revenue of $67.2 million, our testing services revenue at $47.8 million increased approximately 5% as compared to normalized second quarter revenue of $45.6 million. Patient testing services volume appears to be stabilizing as it increased 2% as compared to the last quarter. Number two, our products as well as patient and digital solution businesses delivered another strong performance with each business growing over 30% year-over-year. Number three, adjusted EBITDA losses were pared down to $10.9 million as compared to $18.1 million in the normalized second quarter. Number four, collections were 103% of our reported test and services revenue, making it the fourth consecutive quarter of net positive cash collection. Number five, we maintained a strong cash position of $268.2 million.

第三季業績的主要亮點是：第一，報告收入為 6,720 萬美元，我們的測試服務收入為 4,780 萬美元，與第二季標準化收入 4,560 萬美元相比增長了約 5%。患者檢測服務量似乎穩定下來，與上一季相比增加了 2%。第二，我們的產品以及患者和數位解決方案業務再次表現強勁，每項業務年增超過 30%。第三，調整後的 EBITDA 損失從正常化第二季的 1,810 萬美元減少至 1,090 萬美元。第四，收款占我們報告的測試和服務收入的 103%，使其連續第四個季度實現淨現金收款。第五，我們保持著 2.682 億美元的強勁現金狀況。

And last but not the least, SEC concluded its inquiry and does not intend to demand an enforcement action against the company. Given the strong results in the third quarter of '23, we are raising our revenue guidance for the full year '23 to $274 million to $278 million from our previously announced guidance of $240 million to $260 million.

最後但並非最不重要的一點是，美國證券交易委員會結束了調查，並不打算要求對該公司採取執法行動。鑑於 23 年第三季的強勁業績，我們將 23 年全年的營收指引從先前宣布的 2.4 億美元至 2.6 億美元提高至 2.74 億美元至 2.78 億美元。

Moving to the details. Reported testing services revenue for the third quarter was $47.8 million, up approximately 5% as compared to normalized revenue of $45.6 million in the second quarter. Reported testing services volume for the third quarter was approximately 38,400 tests, up 2% as compared to the last quarter. The volume increase was distributed across all organs. In the third quarter, MolDx covered HeartCare for use in heart transplant surveillance for the first 12 months post-transplant. HeartCare test not meeting the coverage criteria were not recognized in revenues in Q3 post Noridian adoption of the billing article.

轉向細節。據報告，第三季測試服務收入為 4,780 萬美元，比第二季正常化收入 4,560 萬美元成長約 5%。第三季報告的測試服務量約為 38,400 次測試，較上季成長 2%。體積增加分佈在所有器官。第三季度，MolDx 覆蓋了 HeartCare，用於移植後前 12 個月的心臟移植監測。在 Noridian 採用計費文章後，不符合覆蓋標準的 HeartCare 測試未在第三季的收入中確認。

Lastly, our revenues in Q3 were positively impacted by a onetime claim settlement with a large medical advantage payer for outstanding claims. Our non-GAAP testing services gross margin was 74% in the third quarter of '23 as compared to 73% last quarter. Our normalized second quarter testing services non-GAAP gross margin was 68%. Our current quarter gross margin included the onetime benefit of the claims settlement as discussed previously and the benefit of a Stanford royalty accrual reversal, which will now be paid at a lower rate.

最後，我們第三季的收入受到了與大型醫療福利付款人未決索賠的一次性索賠和解的積極影響。 2023 年第三季我們的非 GAAP 測試服務毛利率為 74%，而上一季為 73%。我們第二季標準化測驗服務非 GAAP 毛利率為 68%。我們目前季度的毛利率包括先前討論的索賠和解的一次性收益以及史丹佛大學特許權使用費應計逆轉的收益，現在將以較低的費率支付。

Now turning to other businesses. Our patient and digital solutions business recorded revenue of $9.9 million, a growth of 33% in the third quarter of '23 as compared to a year ago. Non-GAAP gross margin improved 10 percentage points to 39% in the third quarter as compared to 29% in the same quarter last year. Gross margin expansion has been driven by the organic revenue growth, continued cost savings initiatives and higher gross margin profile of our new acquisitions. Our products business delivered $9.5 million in revenue in the third quarter of '23, an increase of 33% as compared to the same quarter last year. Non-GAAP gross margin improved to 58% in the third quarter of '23 as compared to 44% in the same quarter last year, an increase of 14 percentage points. Our goal is to continue to look for opportunities to further improve gross margin for this business. We are continuing to work on site consolidation that will streamline our manufacturing operations, increased efficiency throughout our supply chain and importantly, improve patient care.

現在轉向其他業務。我們的患者和數位解決方案業務在 2023 年第三季營收 990 萬美元，比去年同期成長 33%。第三季非 GAAP 毛利率提高了 10 個百分點，達到 39%，而去年同期為 29%。毛利率的成長是由有機收入成長、持續的成本節約措施以及新收購的毛利率提高所推動的。我們的產品業務在 2023 年第三季實現了 950 萬美元的收入，比去年同期成長了 33%。 2023 年第三季非 GAAP 毛利率提高至 58%，較去年同期的 44% 提高了 14 個百分點。我們的目標是繼續尋找機會進一步提高該業務的毛利率。我們正在繼續進行現場整合，這將簡化我們的製造業務，提高整個供應鏈的效率，更重要的是，改善病患照護。

Turning to operating expenses and adjusted EBITDA. Non-GAAP operating expenses for the third quarter were $57.7 million, down approximately $1.2 million sequentially from Q2 '23. The decrease in our R&D and sales and marketing spend of $4.4 million as compared to last quarter, was driven by the full quarter impact of our actions related to workforce reduction, prioritization of our investments in R&D and continued cost savings and discretionary spend. G&A expense increased $3.2 million as compared to last quarter and driven by various litigation matters in our response to the billing article revision. We are actively working to reduce these transient to elevated expenses. For the third quarter of '23, we reported negative adjusted EBITDA of $10.9 million compared to normalized negative adjusted EBITDA of $18.1 million in the second quarter of '23, an improvement of $7.2 million as compared to last quarter. We are pleased with the progress we have made in reducing adjusted EBITDA losses.

轉向營運費用和調整後的 EBITDA。第三季非 GAAP 營運費用為 5,770 萬美元，比 2023 年第二季減少約 120 萬美元。與上季相比，我們的研發、銷售和行銷支出減少了 440 萬美元，這是由於我們與裁員、優先考慮研發投資以及持續節省成本和可自由支配支出相關的行動對整個季度的影響。與上一季相比，一般管理費用增加了 320 萬美元，這是由於我們對帳單條款修訂的回應中的各種訴訟問題所致。我們正在積極努力減少這些暫時增加的費用。 23 年第三季度，我們報告的負調整 EBITDA 為 1,090 萬美元，而 23 年第二季度正常化負調整 EBITDA 為 1,810 萬美元，比上一季提高了 720 萬美元。我們對在減少調整後 EBITDA 損失方面取得的進展感到高興。

Turning to cash. We continue to maintain a strong balance sheet with cash, cash equivalents and marketable securities of $268.2 million and no debt. For the fourth quarter in a row, our collections were greater than 100% of our testing services revenue. We have now collected over $22 million in incremental cash in the last 4 quarters. As a reminder, we have expanded our collection program to include overdue payments from commercial and Medicare Payers similar to Medicare Advantage. I would also like to note that we earned $3.2 million in interest income in the third quarter of '23. As Alex mentioned earlier, based on our cash position and believe that our stock is currently undervalued, we are continuing to opportunistically pursue stock repurchases.

轉向現金。我們繼續保持強勁的資產負債表，現金、現金等價物和有價證券達 2.682 億美元，無債務。我們的收集量連續第四個季度超過我們測試服務收入的 100%。在過去 4 個季度中，我們已籌集了超過 2,200 萬美元的增量現金。提醒一下，我們已經擴大了收款計劃，將商業和醫療保險付款人的逾期付款納入其中，類似於醫療保險優勢。我還想指出，2023 年第三季我們獲得了 320 萬美元的利息收入。正如亞歷克斯之前提到的，基於我們的現金狀況並認為我們的股票目前被低估，我們將繼續機會主義地進行股票回購。

Turning to the impact of billing article revisions on our financials and mitigation plan. First, billing article revisions added complexity and uncertainty that were disruptive to our business. In the past 2 quarters, we focused our efforts on operational implementation of billing article requirements, both internally and with transplant centers. We made great progress, and the results speak for themselves in terms of new (inaudible) production and supplementation. We are pleased to report that [tier production] for our kidney and heart testing services was over 90% at the end of September, ahead of our initial target. Second, in Q3 '23, we are seeing testing services volumes stabilize across organs and we have implemented necessary changes in our billings and revenue recognition processes.

談到計費文章修訂對我們的財務和緩解計畫的影響。首先，計費文章修訂增加了複雜性和不確定性，對我們的業務造成了破壞。在過去的兩個季度中，我們將工作重點放在內部和移植中心的計費文章要求的營運實施上。我們取得了巨大的進步，其結果在新的（聽不清楚）生產和補充方面是不言而喻的。我們很高興地報告，截至 9 月底，我們的腎臟和心臟檢測服務的[分級生產]已超過 90%，超出了我們的初始目標。其次，在 23 年第三季度，我們看到各個器官的測試服務量穩定，並且我們對帳單和收入確認流程進行了必要的更改。

As you heard from Alex, we believe we are seeing a baseline being set. Our previously announced cost reduction program is largely complete, helping us partially offset the impact of the billing article on our financials. Our goal is to be operating cash flow and adjusted EBITDA positive based on this new level of revenue. And we have levers to bridge the gap, #1, profitable organic growth; #2, increased reimbursement of our unpaid test; #3, reduced G&A expenses, specifically elevated legal spend and finally, drive further efficiencies in our operating expenses. We are actively pursuing each one of these levers.

正如您從亞歷克斯那裡聽到的那樣，我們相信我們正在設定基線。我們先前宣布的成本削減計劃已基本完成，幫助我們部分抵消了計費文章對我們財務狀況的影響。我們的目標是根據新的收入水準實現營運現金流量和調整後 EBITDA 為正值。我們有手段來彌合差距，第一，獲利性有機成長； #2，增加我們未付費測試的報銷；第三，減少一般管理費用，特別是增加法律支出，最後進一步提高我們的營運費用效率。我們正在積極尋求其中的每一個槓桿。

Finally, turning to guidance. Based on the strong results in Q3 '23, we are raising our full year '23 revenue guidance to be in the range of $274 million to $278 million, an increase of $26 million at midpoint. Our revised guidance, #1, assumes Medicare reimbursement remains as currently implemented, #2, assumes approximately $4 million in revenue headwinds going into Q4 associated with the full quarter impact of hot HeartCare tests that are outside of the new coverage criteria post Noridian adoption and the onetime settlement with a large Medicare Advantage payers for outstanding claims and #3, we also assume approximately 5% lower testing services volume due to Q4 seasonality around holidays and potential weather disruption. Based on our assumption of a new revenue baseline being set and with viable levers to which the gap to the cash flow and adjusted EBITDA positive, we do not expect the need to raise cash in foreseeable future. We continue to be proud of the operational excellence and the financial discipline demonstrated by the entire team during the quarter.

最後，轉向指導。基於 23 年第三季的強勁業績，我們將 23 年全年營收指引上調至 2.74 億美元至 2.78 億美元之間，中間增加了 2,600 萬美元。我們修訂後的指導方針#1，假設醫療保險報銷仍然按照目前的實施方式進行，#2，假設進入第四季度的收入逆風約為400 萬美元，這與熱門HeartCare 測試的整個季度影響有關，這些測試超出了Noridian 採用後的新承保標準，並且與大型Medicare Advantage 付款人就未決索賠進行一次性和解以及#3，我們還假設由於第四季度節假日期間的季節性和潛在的天氣幹擾，檢測服務量將減少約5%。基於我們設定新收入基準的假設，以及現金流缺口和調整後 EBITDA 為正值的可行槓桿，我們預計在可預見的未來不需要籌集現金。我們繼續為整個團隊在本季度表現出的卓越營運和財務紀律感到自豪。

With that, I'll hand over to the moderator to open the line for questions.

接下來，我將交給主持人開放提問。

(Operator Instructions) Our first question comes from Andrew Cooper, Raymond James.

（操作員說明）我們的第一個問題來自安德魯庫柏、雷蒙詹姆斯。

Maybe first, just want to make sure I caught you right, probably check on the gross margin dynamics. So can you just give us maybe a dollar amount for the onetime MA settlement just so we can sort of adjust for that? And then as we think about the trajectory from there does 3Q really feel like the stable place in terms of what the cost of goods on testing services can look like? Is there more room to improve on that front? Or is it purely sort of a reimbursement calculus to continue to see the gross margin rise?

也許首先，只是想確保我沒聽錯，可能要檢查毛利率動態。那麼，您能否給我們一筆一次性 MA 結算金額，以便我們對此進行調整？然後，當我們思考從那裡開始的軌跡時，就測試服務的商品成本而言，第三季真的感覺像一個穩定的地方嗎？這方面還有更多改進的空間嗎？還是純粹是為了繼續看到毛利率上升而進行報銷計算？

Yes. Andrew, good to talk to you. And on the gross margin side for the testing services, the 74% is slightly higher because of the couple of onetime events that I called out. And those couple of events, as I called out also in my guidance, they were about $4 million. So if you were to kind of think about the gross margin going forward, I'll take you back to Q2 normalized gross margin, which was about 68%. Now having said that, we have made more progress on our gross margin in Q3. So modeling at about 70%, may not be a bad idea, #1, and #2, of course, we continue to look for more operating leverage come in as the revenue were to grow and as we move forward. But more to come on that as we go forward and probably in the next call.

是的。安德魯，很高興與你交談。在測試服務的毛利率方面，由於我提到的幾起一次性事件，74% 略高。正如我在指導中所指出的那樣，這兩件事的耗資約為 400 萬美元。因此，如果您要考慮未來的毛利率，我會帶您回到第二季的標準化毛利率，約 68%。話雖如此，我們在第三季的毛利率方面取得了更多進展。因此，以大約 70% 為模型，可能不是一個壞主意，#1，#2，當然，隨著收入的增長和我們的前進，我們將繼續尋求更多的營運槓桿。但隨著我們的進展，可能會在下一次電話會議中討論更多內容。

Okay. Helpful. And then I appreciate you sizing the heart surveillance headwind in 4Q. Just curious in terms of what may be on the docket to trying to fight for expansion of that beyond that 12-month window? Do you need incremental studies? Do you feel like there's a way to take what you already have and maybe repackaged in a way that can move the needle there? Just how should we think about the trajectory there on HeartCare and potentially expanding beyond 12 months for surveillance?

好的。有幫助。然後，我感謝您評估第四季心臟監測的逆風。只是好奇，在 12 個月的窗口期之後，努力爭取擴大這一範圍可能包括哪些內容？您需要增量研究嗎？你是否覺得有一種方法可以將你已經擁有的東西重新包裝起來，從而起到推動作用？我們應該如何看待 HeartCare 的發展軌跡以及可能超出 12 個月的監測範圍？

Yes, this is Robert. Thanks for the question. We do see opportunities in various studies and publications that we anticipate coming up, both from CareDx and from some of our customers, key accounts that are using these tests and publishing independently. So we'll be tracking those and looking for those to make a difference sometime in 2024.

是的，這是羅伯特。謝謝你的提問。我們確實在各種研究和出版物中看到了機會，我們預計這些研究和出版物將來自 CareDx 和我們的一些客戶，以及正在使用這些測試並獨立發布的關鍵客戶。因此，我們將追蹤這些內容，並尋找那些能夠在 2024 年某個時候發揮作用的內容。

Okay. Great. And maybe just one last one quickly. With the closing of the SEC issue without any decision to move forward from the body. Anything else you can provide in terms of DOJ or the UPIC audit in terms of progress? Has there been ongoing conversations? Or just what's the timeframe we should think about potentially hearing some amount of closure on the remaining outstanding inquiries.

好的。偉大的。也許很快就只有最後一件事了。隨著 SEC 問題的結束，機構中沒有任何向前推進的決定。關於司法部或 UPIC 審計的進展情況，您還能提供什麼資訊嗎？是否有正在進行的對話？或者我們應該考慮在什麼時間範圍內可能聽到剩餘未決調查的某種程度的結束。

Yes, sure, Andrew. In fact, the whole SEC inquiry that we previously disclosed in the month of September that they sent us the letter and they are not taking any kind of enforcement action. And we are extremely pleased with this outcome. And of course, we were looking into the matters similar to the civil investigative demand that we had received from the DOJ. So having this letter and the conclusion from SEC is a good outcome for us. As far as the DOJ is concerned, probably I'll be speculating if I were to kind of provide more color there, but I just want to say that we are cooperating this matter has been out there for a couple of years. And we'll see as to how soon this matter would be resolving, but nothing more to say on the DOJ side. Robert, do you want to talk about the UPIC side.

是的，當然，安德魯。事實上，我們之前在 9 月披露的整個 SEC 調查中，他們向我們發送了這封信，但他們沒有採取任何形式的執法行動。我們對這個結果非常滿意。當然，我們正在調查與我們從司法部收到的民事調查要求類似的問題。因此，收到這封信和 SEC 的結論對我們來說是一個很好的結果。就司法部而言，我可能會猜測是否要提供更多信息，但我只想說我們正在合作，這件事已經存在了幾年了。我們將看看這個問題多久能解決，但司法部方面沒有更多可說的。羅伯特，你想談談 UPIC 方面嗎？

Yes. I could mention just the UPIC that there was some movement on that in the quarter and they haven't requested any additional claims or taking other actions. And obviously, like any of these audits, we'll intend -- we intend to appeal them. there's always an ongoing appeal process and eventually get to an independent review at some point.

是的。我可以只提及 UPIC，本季在這方面發生了一些變化，他們沒有要求任何額外的索賠或採取其他行動。顯然，就像任何這些審計一樣，我們打算對他們提出上訴。總是會有一個持續的上訴程序，並最終在某個時候進行獨立審查。

Our next question comes from Matt Sukes, Goldman Sachs.

我們的下一個問題來自高盛的馬特·蘇克斯。

This is Prasad on for Matt. Just wanted to get your thoughts on what you're looking for in the search for a new CEO and what the duration of your search looks like?

這是普拉薩德為馬特代言的。只是想了解一下您在尋找新執行長時要尋找什麼以及您的搜尋持續時間是什麼樣的？

Sure. This is Michael. I'll take that one. We're looking for somebody who can continue to execute the strategic plan that we are currently on, improve performance and deliver long-term profitable growth to our investors. In my experience, it generally takes 6 to 9 months to install, not to identify, but to install a new CEO. So the Board is entirely confident of the executive leadership team in place today to be able to put the plan together that they will be solely responsible for executing in 2024.

當然。這是邁克爾。我會接受那個。我們正在尋找能夠繼續執行我們目前正在進行的策略計劃、提高業績並為我們的投資者帶來長期獲利成長的人。根據我的經驗，通常需要6到9個月的時間來安裝，不是確定，而是安裝新的CEO。因此，董事會對今天到位的執行領導團隊完全有信心製定計劃，並在 2024 年全權負責執行。

Our next question comes from Brandon Couillard, Jefferies.

我們的下一個問題來自 Jefferies 的 Brandon Couillard。

This is Matt on for Brandon. I appreciate all the color around kind of volumes stabilizing and then the number of initiatives underway to get to adjusted EBITDA and cash flow positive goals. Any more clarity you can provide in terms of timing on those now that you feel a bit more comfortable with both the cost actions and kind of stabilization of volumes? How should we think about when you could hit those targets?

這是布蘭登的馬特。我欣賞圍繞著銷售穩定的所有色彩，以及為實現調整後的 EBITDA 和現金流積極目標而採取的舉措數量。既然您對成本行動和銷售穩定感到更加滿意，您可以在時間安排方面提供更多的說明嗎？我們應該如何考慮何時可以實現這些目標？

Yes. I'll probably take like a step back here that last year in Q3, we put a stake in the ground that we're going to be profitable in the first half of this year. And had we not been impacted by the billing article, we would have been profitable in the Q1 itself of this year. Then we were hit by the billing article. And if you recall in the second quarter, our testing services dropped by almost like $25 million on an apple-to-apple basis that I called out in my last script. So you are looking at about $100 million of GAAP to bridge there. And if you look at the adjusted EBITDA now, which is at about $11 million for the current quarter, I think we are extremely proud and pleased with the progress that we have made on this particular goal of returning to operating cash flow positive and adjusted EBITDA positive.

是的。我可能會退一步說，去年第三季度，我們押注了我們將在今年上半年實現盈利的基礎。如果我們沒有受到計費文章的影響，我們將在今年第一季實現盈利。然後我們就被帳單文章擊中了。如果你還記得，在第二季度，我們的測試服務在蘋果之間下降了近 2500 萬美元，正如我在上一個腳本中所說的那樣。因此，您需要大約 1 億美元的 GAAP 來彌補這一差距。如果你現在看看調整後的 EBITDA，本季約為 1100 萬美元，我認為我們對我們在恢復營運現金流為正值和調整後 EBITDA 這一特定目標方面所取得的進展感到非常自豪和高興積極的。

On specific timing, we will provide more color in our next call because we have multiple levers, as I was kind of alluding to that we have probably secular growth in the transplant volume market and in our testing services volume. And then, of course, how we are able to kind of get paid on some of the tests that we are not getting paid because there is a renewed focus on the coverage and everything. And of course, if we need to be more thoughtful on our operating structure and be more efficient and effective there, that is definitely on the table, too. So there are multiple levers, and we have made good progress. We feel comfortable where we are, but in terms of the specific timelines, we'll wait for the next quarter call that we have a little bit more information as to how things are stabilizing in Q4.

在具體時間上，我們將在下次電話會議中提供更多信息，因為我們有多個槓桿，正如我暗示的那樣，我們的移植量市場和我們的測試服務量可能會長期增長。當然，我們如何在一些測試中獲得報酬，而我們沒有得到報酬，因為我們重新關注了覆蓋範圍和一切。當然，如果我們需要更加深思熟慮我們的營運結構並提高效率和效果，這也絕對是擺在桌面上的。所以有多種槓桿，我們已經取得了良好的進展。我們對目前的情況感到滿意，但就具體時間表而言，我們將等待下一個季度的電話會議，我們將獲得更多關於第四季度情況如何穩定的資訊。

Our next question comes from Mark Massaro, BTIG.

我們的下一個問題來自 BTIG 的 Mark Massaro。

This is [Billie] on for Mark. So last quarter, you discussed clinic hesitation around ordering kidney surround testing. It appears like this dynamic might be behind us. So can you just discuss what factors or headwinds sort of rolled off for you to drive these volumes here in Q3. And can you just remind us of any onetime benefit or prior period collections that happened here in Q3? I know you spoke about the Medicare one-timer, but just any other one-timers that we should be backing out?

這是馬克的[比莉]。上個季度，您討論了臨床對進行腎臟周圍檢測的猶豫。看來這種動態可能已經過去了。那麼，您能否討論一下在第三季推動這些銷售成長的因素或阻力是什麼？您能否提醒我們第三季發生的任何一次性福利或前期收款？我知道您談到了醫療保險一次性計劃，但我們應該取消其他一次性計劃嗎？

Thanks. And I think we're really pleased with some of the progress that we've seen over the last 6 months. One of the effects of having 6 months to do this is a lot of the transplant centers now have had time to update their systems, their procedures, the education. So where I think there was a lack of understanding of not just how to do things, but what to do. Now clinicians have had enough time to absorb this and really institutionalize what they're thinking. So we're very much looking ahead and feel very good that these centers have a very good understanding of where their ordering is today and opportunities for the future.

謝謝。我認為我們對過去 6 個月所取得的一些進展感到非常滿意。 6 個月的時間來完成這項工作的效果之一是，許多移植中心現在有時間更新他們的系統、程序和教育。所以我認為，人們不僅不了解如何做事，也不了解做什麼。現在臨床醫生有足夠的時間來吸收這一點並將他們的想法真正制度化。因此，我們非常展望未來，並感到非常高興，因為這些中心非常了解他們今天的訂單狀況和未來的機會。

Sure. And let me take the second part of your question around the onetimers in Q3. I called out a couple of those pieces. The first one is after the Noridian adopted the billing article on the HeartCare, we are not recognizing that revenue of post that adoption. So that means going into Q4, the revenue that we recognize for those HeartCare tests prior to the Noridian adoption, that will not be available into Q4. And the second event is this onetime claim settlement and the number is about $4 million for these 2 events. So that's the piece that I would call out on the onetime. But other than that, there isn't a material that would need to be modeled from the numbers standpoint.

當然。讓我回答你問題的第二部分，圍繞著第三季的一次性者。我調出了其中幾件。第一篇是在 Noridian 採用 HeartCare 的計費文章之後，我們沒有確認採用後的收入。因此，這意味著進入第四季度，我們在採用 Noridian 之前為 HeartCare 測試確認的收入將無法進入第四季度。第二個事件是一次性理賠，這兩個事件的金額約為400萬美元。這就是我一次性要強調的內容。但除此之外，沒有任何材料需要從數字的角度進行建模。

Okay. Perfect. Understood. And then I guess, any updates to provide on when we might see a readout on the SHORE study. Can you just remind us what studies we've completed or underway that support these of HeartCare and just how you're thinking about additional evidence generation on that front.

好的。完美的。明白了。然後我想，當我們可能看到海岸研究的讀數時，可以提供任何更新。您能否提醒我們，我們已經完成或正在進行哪些研究來支持​​ HeartCare 的這些研究，以及您如何考慮在這方面產生額外的證據。

Sure. We're actively in analysis on the SHORE data, including data monitoring. This is an ongoing study but we're looking at an interim readout and so working on putting that together with the goal of getting some publication -- 1 or 2 publications out in 2024. And just a reminder that AlloSure Heart and AlloMap Heart are both already covered without restriction on time. The question earlier about extending beyond 12 months is only for the combined HeartCare results. And in many cases, when docs have a specific need and reason and desire for the best management of patients to order HeartCare will work with them to submit for payments for those from Medicare and to appeal any demands.

當然。我們正在積極分析海岸數據，包括數據監測。這是一項正在進行的研究，但我們正在研究臨時讀數，因此正在努力將其整合在一起，目標是在 2024 年發表 1 到 2 篇出版物。只是提醒一下，AlloSure Heart 和 AlloMap Heart 都是已經涵蓋，沒有時間限制。先前關於延長超過 12 個月的問題僅針對綜合 HeartCare 結果。在許多情況下，當醫生有特定的需求、理由和希望對患者進行最佳管理時，HeartCare 將與他們合作，為 Medicare 的患者申請付款，並對任何要求提出上訴。

Our next question comes from Alex Nowak, Craig-Hallum Capital Group.

我們的下一個問題來自 Craig-Hallum 資本集團的 Alex Nowak。

I want to go back around the CEO transition. Maybe just expand on the departure of Reg. There's obviously a lot of moving parts here with the story. I think the company needs a leader out there to navigate through all those moving parts. So why the departure now? And just how important is to the Board to name a successor fairly quickly here to guide the company during the challenging time.

我想回顧一下執行長的過渡。也許只是擴展Reg的離開。這個故事顯然有很多令人感動的部分。我認為公司需要一位領導者來應對所有這些變化的部分。那為什麼現在離開呢？對於董事會來說，盡快任命繼任者以在充滿挑戰的時期指導公司是多麼重要。

Yes. Alex, this is Michael. These are complex situations and there's elements of it that are personal in nature. So I'm not going to provide much more on that other than to say it was mutual and the time was right. In part, the time was right because the company at Board wanted to set themselves up for success in 2024, and we're into the planning process for establishing that budget and operating plan now. So we wanted to make sure that extraordinarily capable group of senior leaders that Reg had cultivated. We're in a position to be 100% responsible for constructing that plan because they're going to be 100% responsible for its execution.

是的。亞歷克斯，這是麥可。這些都是複雜的情況，其中有些因素本質上是個人的。因此，除了說這是相互的並且時機成熟之外，我不會提供更多內容。在某種程度上，時機是正確的，因為董事會希望為 2024 年的成功做好準備，我們現在正在進入預算和營運計畫的規劃流程。因此，我們希望確保雷格培養出一支能力非凡的高階領導團隊。我們能夠 100% 負責制定該計劃，因為他們將 100% 負責其執行。

Now we think that the executive team here is stable. We think they are extraordinarily capable and well qualified and experienced in this business. And by virtue of the structure that we've set up an office of the CEO with Abhishek, Alex and myself. We meet on a daily basis. There is no missed beats or decisions deferred we're operating the business as a functional CEO. So we're prepared to operate in that fashion until the Board is comfortable that we've got a CEO identified and installed. So I wouldn't worry. In fact, I would be cautiously excited.

現在我們認為這裡的執行團隊是穩定的。我們認為他們在這個行業中能力非凡、資質良好、經驗豐富。根據這種結構，我們與 Abhishek、Alex 和我一起設立了執行長辦公室。我們每天都會見面。我們以職能執行長的身份經營公司，不會錯過任何節奏或延遲決策。因此，我們準備以這種方式運作，直到董事會對我們已經確定並任命了一位執行長感到滿意為止。所以我不會擔心。事實上，我會​​謹慎地興奮。

Okay. Understood. I appreciate all the information there. And then again, on the revenue and the cash burn, we can kind of go into little pieces there. But just to kind of level set us, if we take the revenue from this quarter, call it, $270 million on an annualized basis, is that going to be a floor that we can then grow off of for 2024? And then same thing on the cash burn. If you just look at the cash change, about $60 million of cash burn annualized this quarter. I assume that's got to be the low point here, and we're only going to get better on the go forward. Is that all correct?

好的。明白了。我很欣賞那裡的所有資訊。話又說回來，關於收入和現金消耗，我們可以稍微討論一下。但就我們而言，如果我們將本季的營收（按年化​​計算）稱為 2.7 億美元，這是否會成為我們在 2024 年實現成長的下限？然後在燒錢方面也是如此。如果只看現金變化，本季的年化現金消耗約為 6,000 萬美元。我認為這一定是這裡的最低點，我們只會在前進中變得更好。這一切都正確嗎？

Yes, Alex, maybe a couple of changes there in those assumptions. But firstly, on the cash, for example. So the overall reduction of about $14.5 million, that includes your investing activities we called out the acquisitions there. If you look at our operating cash, that's about $10 million. So that probably would be the first piece that I will call out. And maybe the second piece that I would suggest on the cash burn to have a look because we were impacted by the billing articles in Q2. So look at the testing services impact of the billing article in the last 2 quarters and how much cash burn did we really have on the operating side in the last 2 quarters. That will give you some sense as to the cash burn would probably be in that range going forward without company taking any actions.

是的，亞歷克斯，這些假設可能會有一些變化。但首先，例如現金。因此，總體減少了約 1450 萬美元，其中包括我們在那裡進行的收購的投資活動。如果你看一下我們的營運現金，大約是 1000 萬美元。所以這可能是我要提到的第一件事。也許我建議看一下關於現金消耗的第二篇文章，因為我們受到了第二季計費文章的影響。因此，看看過去兩個季度的計費文章對測試服務的影響，以及過去兩個季度我們在營運方面實際消耗了多少現金。這會讓你感覺到，如果公司不採取任何行動，未來的現金消耗可能會在這個範圍內。

And then I called out that, okay, how do I reduce that cash burn. So the reduction in the cash burn, again, comes from the multiple levers that we are currently assessing. We brought down the impact of the billing article from, say, $100 million to now the adjusted EBITDA losses of, say, $11 million in the current quarter. Now we need to bridge this remaining gap. And revenue growth, the secular growth that could be out there in the market, the transplant volume market has been growing in the high single digits and how we continue to kind of grow our testing services volume alongside that. That would be our first lever.

然後我大聲說，好吧，我該如何減少現金消耗。因此，現金消耗的減少再次來自我們目前正在評估的多種槓桿。我們將帳單文章的影響從 1 億美元減少到當前季度調整後的 EBITDA 損失，例如 1,100 萬美元。現在我們需要彌合這一剩餘差距。收入成長、市場可能出現的長期成長、移植量市場一直以高個位數成長，以及我們如何繼續增加我們的測試服務量。那將是我們的第一個槓桿。

The second lever, of course, is going to be that how do we continue to work with our commercial payers to improve the coverage and continue to expand our collection program to be able to get paid, how we have been paid in the last few quarters to reduce the cash burn. And of course, the third lever that is definitely on the table is looking into our cost structure, specifically all the legal expenses, if you were to pay down the SG&A, be it the G&A spend back to the levels where we were in the second half of last year prior to the billing article impact that will give you another sense as to how much higher the G&A spend has been because of the billing article. So we have the levers here to be able to reduce that cash burn. I'll basically make certain assumptions. So that I'm in the ballpark. And I'll provide more color on most of these in our next earnings call. But the $15 million is not the cash burn in my mind of third quarter.

當然，第二個槓桿將是我們如何繼續與我們的商業付款人合作以提高覆蓋範圍並繼續擴大我們的收款計劃以獲得付款，我們在過去幾個季度的付款方式以減少現金消耗。當然，第三個槓桿肯定是在研究我們的成本結構，特別是所有法律費用，如果你要支付 SG&A，無論 G&A 支出回到我們第二個階段的水平去年半年，在賬單文章影響之前，您將有另一種感覺，即因帳單文章而導致的一般管理費用(G&A) 支出增加了多少。因此，我們有辦法減少現金消耗。我基本上會做出某些假設。這樣我就在球場上了。我將在下一次財報電話會議上對其中大部分內容提供更多資訊。但 1500 萬美元並不是我心目中第三季的現金消耗。

Excellent. Very helpful. And then just a final question here. I was looking through the 10-Q during the prepared remarks and I know reimbursement is always was a tricky item. And I'm just trying to understand the interpretation on some of the HeartCare language in the 10-Q, the 10-Q talks about letters being submitted to Noridian claiming why HeartCare should be covered. And so the question is really, is Noridian actually reimbursing for HeartCare right now and the company is getting paid for that? Or is it more CareDx's interpretation that Noridian should be getting paid for HeartCare?

出色的。很有幫助。然後是最後一個問題。在準備發言時我正在查看 10-Q，我知道報銷始終是一個棘手的項目。我只是想理解 10-Q 中一些 HeartCare 語言的解釋，10-Q 討論了提交給 Noridian 的信件，聲稱為什麼應該承保 HeartCare。所以問題是，Noridian 現在是否真的在償還 HeartCare，並且該公司正在為此獲得報酬？或者這更像是 CareDx 的解釋，即 Noridian 應該為 HeartCare 獲得報酬？

So Andrew, this has been a year where things have been so very complicated, and we want to be more transparent in our 10-Q, and we have provided the disclosures in a lot more detail. But let me unravel that for you. On the HeartCare basically after the Noridian adoption, which was [8/16], post that, we have not revenue recognized any test on the HeartCare, which is, say, not for surveillance and greater than one year. So that's completely out. So that's exactly what it says, nothing more than that we are in compliance with what Noridian adopted on 8/16 is as simple as that. So the baseline has already been set based on everything which is out there from the billing article standpoint and what we've been asked to do on the coverage standpoint.

安德魯，今年事情變得非常複雜，我們希望在 10-Q 中更加透明，並且我們提供了更詳細的披露。但讓我為你解開這個謎。關於 HeartCare，基本上是在 Noridian 採用之後（即 [8/16]），發布後，我們尚未確認對 HeartCare 進行任何測試，也就是說，不是用於監控且超過一年。所以這完全是不可能的了。所以這正是它所說的，無非就是我們遵守 Noridian 在 8/16 所採用的內容，就這麼簡單。因此，基準已經根據計費文章的角度以及我們被要求在覆蓋範圍的角度所做的一切來設定。

Our next question comes from Mason Carrico, Stephens.

我們的下一個問題來自梅森·卡里科·史蒂芬斯。

This is Jacob Krahenbuhl on for Mason. I appreciate the color around volumes funding like a more stabilized level this quarter actually increased slightly sequentially. But just wondering, given you found a stabilized level, given the multiple iterations to the billing article and the LCD as well as the recent coverage room with HeartCare. Could you maybe give us some color whether qualitatively or quantitatively on growth across organ type, specifically heart and kidney?

我是雅各‧克雷恩布爾 (Jacob Krahenbuhl)，代表梅森 (Mason) 發言。我很欣賞融資量的色彩，例如本季更加穩定的水平實際上比上季略有增加。但只是想知道，考慮到您發現了一個穩定的水平，考慮到計費文章和 LCD 的多次迭代以及最近 HeartCare 的覆蓋室。您能否給我們一些關於器官類型（特別是心臟和腎臟）生長的定性或定量的資訊？

Yes. Sure. I can -- this is Alex. I can give a little bit of context on that, Jake. I think for the growth in volumes and test and service volumes this past quarter, we saw growth from all 3 organs. And so we felt very good that this is -- this baseline now has really created the stabilization that we can grow from.

是的。當然。我可以——這是亞歷克斯。傑克，我可以提供一些相關背景資訊。我認為，就上個季度的數量以及測試和服務量的增長而言，我們看到了所有 3 個器官的增長。所以我們感覺非常好，這個基線現在確實創造了我們可以成長的穩定性。

Our final question comes from Dipesh Patel, H.C. Weinright.

我們的最後一個問題來自 H.C. Dipesh Patel。溫賴特。

This is Dipesh on for Yi. Could you perhaps clarify if you expect to see any further updates from MolDx regarding the coverage of molecular transplant tests as part of routine monitoring care to detect organ rejection.

這是迪佩什（Dipesh）代表易建聯發言。您能否澄清一下，您是否希望看到 MolDx 關於分子移植測試覆蓋範圍的任何進一步更新，作為檢測器官排斥的常規監測護理的一部分。

I think where we're at right now is that after a couple of iterations of a billing article and the perspective of the community, and those are changes to coverage. And they then propose a draft LCD that is now open for comment. And so it was the open comment period for 2 of the [max] has already passed 2 more are in process. And then we would expect them to move forward and based on the draft and the comments they've received produce a final coverage policy from that. And so that's, I think, what we would expect to happen. We've been surprised in the past, different from our expectations, but that's the normal process. And the timing around that is something we're often asked, and that's sometimes before August of next year, if there's a rule that has to be finished before the original draft was released.

我認為我們現在所處的位置是，在計費文章和社區的觀點經過幾次迭代之後，這些都是覆蓋範圍的變化。然後他們提出了一份 LCD 草案，現已開放徵求意見。因此，現在是公開徵求意見期，其中 2 個 [max] 已經過去，另外 2 個正在處理中。然後我們希望他們繼續前進，並根據草案和收到的意見制定最終的覆蓋政策。我認為這就是我們期望發生的情況。過去我們感到驚訝，與我們的預期不同，但那是正常過程。我們經常被問到這個時間安排，有時是在明年八月之前，是否有一條規則必須在原始草案發布之前完成。

Got it. That's very helpful. And then lastly, how might you expect the testing volume to grow sequentially going forward?

知道了。這非常有幫助。最後，您預計未來測試量將如何持續成長？

Look, I think we're certainly in this quarter, certainly, there's nothing that would make us change from the guidance and the thinking that we've seen so far. So I think now that we've seen a baseline being set, I think there's growth ahead of us, and we'll have to see how the quarter plays out, certainly in terms of weather and winter storms and such. But we're feeling like we've certainly hit some stabilization in a baseline that we can grow from.

聽著，我認為我們肯定在這個季度，當然，沒有什麼能讓我們改變迄今為止我們所看到的指導和想法。因此，我認為現在我們已經設定了基準，我認為我們前面還有成長，我們必須看看本季的表現如何，當然在天氣和冬季風暴等方面。但我們感覺我們的基線確實已經穩定下來，我們可以從中成長。

We have no further questions in the queue at this time. I would now like to turn the call back over to today's speakers.

目前我們隊列中沒有其他問題。我現在想把電話轉回給今天的講者。

Great. Thank you. We wish you the very best this afternoon. Thank you all.

偉大的。謝謝。我們祝福您今天下午一切順利。謝謝你們。

This does conclude today's program. Thank you for your participation. You may disconnect at any time.

今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。