Veracyte Inc (VCYT) 2024 Q2 法說會逐字稿

Good day and thank you for standing by, and welcome to the Veracyte second-quarter 2024 financial results call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持，歡迎參加 Veracyte 2024 年第二季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your first speaker today, Shayla Gorman, Senior Director, Investor Relations. Please go ahead.

現在我想將會議交給今天的第一位發言人，投資者關係高級總監 Shayla Gorman。請繼續。

Good afternoon, everyone, and thank you for joining us today for a discussion of our second-quarter 2024 financial results. With me today are Marc Stapley, Veracyte's Chief Executive Officer; and Rebecca Chambers, our Chief Financial Officer. Veracyte issued a press release earlier this afternoon detailing our second-quarter 2024 financial results. This release, along with the business and financial presentation, is available in the Investor Relations section of our website at veracyte.com.

大家下午好，感謝您今天加入我們討論我們的 2024 年第二季財務業績。今天和我在一起的有 Veracyte 執行長 Marc Stapley；以及我們的財務長麗貝卡‧錢伯斯 (Rebecca Chambers)。Veracyte 今天下午早些時候發布了一份新聞稿，詳細介紹了我們 2024 年第二季的財務表現。本新聞稿以及業務和財務簡報可在我們網站 veracyte.com 的投資者關係部分取得。

Before we begin, I'd like to remind you that various statements that we may make during this call will include forward-looking statements as defined under applicable securities laws. Forward-looking statements are subject to risks and uncertainties, and the company can give no assurance they will prove to be correct. Additionally, we are not under any obligation to provide further updates on our business trends or our performance during the quarter. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Veracyte files with the Securities and Exchange Commission, including Veracyte's most recent Forms 10-Q and 10-K.

在我們開始之前，我想提醒您，我們在本次電話會議中可能做出的各種聲明將包括適用證券法定義的前瞻性聲明。前瞻性陳述存在風險和不確定性，公司不能保證這些陳述將被證明是正確的。此外，我們沒有義務提供有關本季業務趨勢或業績的進一步更新。為了更了解可能導致實際結果不同的風險和不確定性，我們建議您參閱 Veracyte 向美國證券交易委員會提交的文件，包括 Veracyte 最新的表格 10-Q 和 10-K。

In addition, this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures are included in today's earnings release accessible from the IR section of Veracyte's website. This quarter, we have updated our non-GAAP measures to exclude stock-based compensation to provide better comparison to our peers and help investors gain a better understanding of our performance. Further, all comparisons to prior periods are to the updated non-GAAP metrics that exclude stock-based compensation. We have included a schedule of the non-GAAP adjustment for prior periods in today's earnings presentation available on the Investors section of our website.

此外，本次電話會議還將包括某些非公認會計準則財務指標。這些指標與最直接可比較的 GAAP 財務指標的調整包含在今天的收益發布中，可從 Veracyte 網站的 IR 部分存取。本季度，我們更新了非公認會計原則衡量標準，排除了基於股票的薪酬，以便更好地與同行進行比較，並幫助投資者更好地了解我們的業績。此外，與前期的所有比較都是針對更新後的非公認會計原則指標，不包括基於股票的薪酬。我們在今天的收益報告中包含了前期非公認會計原則調整的時間表，可在我們網站的投資者部分查看。

I will now turn the call over to Marc Stapley, Veracyte's CEO.

我現在將把電話轉給 Veracyte 執行長 Marc Stapley。

Thanks, Shayla, and thanks, everyone, for joining us today. I couldn't be more pleased to share with you the drivers of what I believe is Veracyte's best quarter to date. Importantly, we saw an acceleration of demand for both Decipher and Afirma that exceeded even our highest expectations coming into the quarter. As a result, we delivered second-quarter revenue of $114.4 million, growing 27% compared to the prior-year period. Testing revenue grew 31% over the prior-year period, well ahead of our expectations.

謝謝 Shayla，也謝謝大家今天加入我們。我非常高興與您分享我認為 Veracyte 迄今為止最好的季度的驅動因素。重要的是，我們看到對 Decipher 和 Afirma 的需求加速成長，甚至超出了我們進入本季度的最高預期。因此，我們第二季的營收為 1.144 億美元，比去年同期成長 27%。測試收入較上年同期成長 31%，遠超我們的預期。

With our disciplined focus and strong fiscal management, this overperformance on top-line growth contributed to our most profitable quarter to date. We generated $5.7 million in GAAP net income and our adjusted EBITDA margin was an industry-leading 21%. I have previously stated that I believe a well-run specialty diagnostics company like ours could achieve 25% adjusted EBITDA margins, and as you can see, we are well on our way to reaching that level of profitability.

憑藉我們嚴格的重點和強大的財務管理，這種超額成長的營收成長為我們迄今為止最盈利的季度做出了貢獻。我們的 GAAP 淨利潤為 570 萬美元，調整後 EBITDA 利潤率為業界領先的 21%。我之前曾說過，我相信像我們這樣經營良好的專業診斷公司可以實現 25% 的調整後 EBITDA 利潤率，正如您所看到的，我們正在努力實現這一盈利水平。

Before I get into this quarter's performance, I want to remind you that we are highly focused on five strategic imperatives: one, continued growth in Decipher; two, continued growth in Afirma; three, launch of multiple IVD products to expand geographically; four, solving new cancer challenges; and five, serving more of the patient journey.

在介紹本季的業績之前，我想提醒大家，我們要高度關註五個策略要務：一是 Decipher 的持續成長；二、Afirma持續成長；三、推出多種IVD產品，拓展地域；四、解決癌症新挑戰；五是為患者的旅程提供更多服務。

Regarding number three, I am pleased to share that we just submitted our existing Prosigna nCounter test for approval under the IVDR framework. Recall that this is a foundational step that we expect to enable the launch of future IVD test in oncology around the world and drive the commercialization of our IVD portfolio. Turning to number four, we're making good progress on solving new cancer challenges with NIGHTINGALE, our pivotal trial for naval swab. And with respect to number five, we continue to forge our way across the patient journey with the development of our first MRD test for muscle-invasive bladder cancer using our whole genome platform, a platform that is extensible across multiple indications.

關於第三點，我很高興地告訴大家，我們剛剛提交了現有的 Prosigna nCounter 測試，以供 IVDR 框架下的批准。回想一下，這是一個基礎步驟，我們希望能夠在全球範圍內啟動未來的腫瘤學 IVD 測試，並推動我們的 IVD 產品組合的商業化。談到第四點，我們在利用 NIGHTINGALE（我們的海軍拭子的關鍵試驗）解決新的癌症挑戰方面取得了良好進展。關於第五點，我們繼續在患者旅程中開闢道路，使用我們的全基因組平台（一個可跨多種適應症擴展的平台）開發了我們的第一個肌肉浸潤性膀胱癌 MRD 測試。

We expect these three longer-term strategic imperatives will layer on new revenue growth S curves a number of years from now on top of what we believe is durable Decipher and Afirma growth.

我們預計，除了我們認為的 Decipher 和 Afirma 的持久增長之外，這三個長期戰略要務將在幾年後形成新的收入成長 S 曲線。

Now, turning to the current quarter. I have talked before about the power of our Veracyte Diagnostics platform, which I believe is behind our strong performance and impressive growth. This unique approach relies on broad sets of genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence generation engine. This flywheel for growth builds increasingly strong and differentiated evidence to clinical validity and utility that ultimately drive guideline inclusion, and combined with our proven commercial and managed care excellence, ensures broad adoption and reimbursement for our on-market diagnostics.

現在，轉向當前季度。我之前曾談到我們 Veracyte Diagnostics 平台的強大功能，我相信這是我們強勁業績和令人矚目的成長背後的原因。這種獨特的方法依賴廣泛的基因組和臨床數據、深入的生物資訊學和人工智慧功能以及強大的證據生成引擎。這種成長飛輪為臨床有效性和實用性建立了越來越強大和差異化的證據，最終推動指南的納入，並與我們經過驗證的商業和管理護理卓越性相結合，確保我們的市場診斷的廣泛採用和報銷。

Evidence of this can be seen in the positive trend in ASP we've delivered, driven by our managed care and billing teams, ensuring that patients who are indicated for diagnostic testing are able to access those tests and that we have paid appropriately and timely when our products are selected by physicians for those patients. Our ASP has grown at a 5% CAGR over the last two years, as we focused on gaining new contracts and resolving prior-payment challenges.

這一點可以從我們交付的ASP 的積極趨勢中看出，在我們的管理式護理和計費團隊的推動下，確保需要進行診斷測試的患者能夠獲得這些測試，並且我們在適當且及時的情況下支付了費用我們的產品是由醫生為這些患者選擇的。過去兩年，我們的平均售價以 5% 的複合年增長率成長，因為我們專注於獲得新合約並解決提前付款的挑戰。

Another key to the Veracyte Diagnostics platform is the flywheel of evidence generation led by our clinical and medical teams that fuels adoption and guideline inclusion. The outstanding Decipher and Afirma volume growth that we're seeing is a direct result of this flywheel in action, together with the execution of our talented commercial teams.

Veracyte Diagnostics 平台的另一個關鍵是由我們的臨床和醫療團隊領導的證據產生飛輪，促進採用和指南納入。我們所看到的 Decipher 和 Afirma 銷量的出色增長是飛輪發揮作用以及我們才華橫溢的商業團隊執行力的直接結果。

Specifically on urology testing, for the second year in a row, we saw a step function change in demand for Decipher during the second quarter. Sequentially, Decipher prostate grew by 3,400 tests, as we delivered approximately 19,900 tests in the quarter, a new record, now reaching more patients in a single month than we did in a whole quarter when we acquired Decipher in 2021.

特別是在泌尿科測試方面，我們連續第二年看到第二季對 Decipher 的需求發生階躍函數變化。隨後，Decipher 前列腺檢測量增加了3,400 次，我們在本季度進行了約19,900 次檢測，創下了新紀錄，現在單月覆蓋的患者數量比我們2021 年收購Decipher 時整個季度覆蓋的患者數量還要多。

Importantly, volume growth, which equated to 32% year over year, was driven by both new physician adoption and deeper penetration into existing accounts. This is another favorable data point that gives us the confidence that Decipher has plenty of headroom for durable future growth with the majority of the market still unpenetrated.

重要的是，銷售成長（年增 32%）是由新醫生的採用和對現有帳戶的更深入滲透所推動的。這是另一個有利的數據點，它讓我們相信，在大多數市場尚未滲透的情況下，Decipher 擁有足夠的空間來實現未來的持久成長。

The updated NCCN guidelines published in February were a significant catalyst to adoption, as Decipher Prostate received the highest evidence level rating among molecular test in the guidelines and was included in the principles of risk stratification section, which details treatment implications based on the NCCN classification and Decipher score. This result underscores both the mountain of evidence behind the test, as well as its broad utility for patients diagnosed with prostate cancer from those who are low risk and on active surveillance to those who are intermediate risk, all the way up to NCCN high-risk patients and patients after surgery.

2 月發布的更新版NCCN 指南是採用的重要催化劑，因為Decipher Prostate 在指南中的分子測試中獲得了最高的證據等級評級，並被納入風險分層原則部分，該部分詳細介紹了基於NCCN 分類和治療的影響。這項結果強調了該測試背後的大量證據，以及它對診斷患有前列腺癌的患者的廣泛實用性，從低風險和主動監測的患者到中風險的患者，一直到 NCCN 高風險的患者患者和手術後的患者。

Even with the level of evidence behind the Decipher prostate test today, we are committed to continuing to support additional research to advance prostate cancer science. In the second quarter alone, there were three newly published Decipher prostate test studies, including a real-world data population-based analysis of Decipher linked to the National Cancer Institute's SEER database demonstrating the test's clinical utility.

即使如今 Decipher 前列腺測試背後的證據水平很高，我們仍致力於繼續支持更多研究，以推進前列腺癌科學。僅在第二季度，就有三項新發表的 Decipher 前列腺測試研究，其中包括與國家癌症研究所 SEER 數據庫關聯的基於真實世界數據人群的 Decipher 分析，展示了該測試的臨床實用性。

And we are very eager to be able to offer prognostic and predictive insights to patients with metastatic disease, a cohort for whom more information can make an even greater difference of pivotal moments in their cancer journeys. Given that WPS issued a local coverage determination or LCD for metastatic prostate cancer last week, we now expect the finalization of the Palmetto LCD soon. This will provide an additional vector for growth accounting for an estimated 30,000 of the 300,000 newly diagnosed prostate cancer patients annually.

我們非常渴望能夠為轉移性疾病患者提供預後和預測見解，對於這些患者來說，更多資訊可以在他們癌症旅程的關鍵時刻產生更大的影響。鑑於 WPS 上週發布了轉移性前列腺癌的局部覆蓋確定或 LCD，我們現在預計 Palmetto LCD 很快就會最終確定。這將為每年 30 萬名新診斷的前列腺癌患者中的約 30,000 名患者提供額外的增長載體。

Moving to Afirma, we also reported a new quarterly volume record with approximately 15,700 test results or 17% year-over-year growth. This performance for test has been on the market for over a decade is a testament to our diagnostic platform and commercial approach and supports our positive outlook for our long-term growth profile, fueled by both Decipher and Afirma. The differentiated level of evidence for the performance of the Afirma test, alongside the ease of use for physicians, drove volume increases with growth coming from new customers and our current customer base.

至於 Afirma，我們也報告了新的季度銷售記錄，約有 15,700 個測試結果，年增 17%。這種測試性能已經上市十多年，證明了我們的診斷平台和商業方法，並支持我們對在 Decipher 和 Afirma 的推動下的長期增長前景的積極展望。Afirma 測試表現的證據等級差異化，以及醫生的易用性，隨著新客戶和我們現有客戶群的成長，推動了銷售量的成長。

Our research-use-only or RUO Afirma GRID offering is another way we continue to further our leadership in the endocrinology market. This tool provides physicians with additional data to advance the science around thyroid nodules and cancer. This quarter at ENDO 2024, the Annual Meeting of the Endocrine Society, three studies leveraging information from Afirma GRID were presented, highlighting the importance of this tool in helping to unlock new molecular insights from thyroid tumors, which may ultimately further personalize treatment of the disease. This quarter, approximately half of physicians ordering Afirma chose to receive the RUO Afirma GRID information, demonstrating a high level of interest in contributing to research.

我們的僅供研究使用或 RUO Afirma GRID 產品是我們繼續鞏固在內分泌市場領導地位的另一種方式。該工具為醫生提供了額外的數據，以推進甲狀腺結節和癌症的科學發展。本季度，在內分泌學會年會ENDO 2024 上，提出了三項利用Afirma GRID 資訊的研究，強調了該工具在幫助解鎖甲狀腺腫瘤新分子見解方面的重要性，這最終可能進一步實現該疾病的個性化治療。本季度，大約一半訂購 Afirma 的醫生選擇接收 RUO Afirma GRID 訊息，這表明他們對為研究做出貢獻的高度興趣。

We also achieved a significant milestone in June, as MolDX finalized an expanded local coverage determination for Afirma, adding reimbursement for Medicare and Medicare Advantage patients with Bethesda V thyroid nodules for those that are suspicious for cancer. There are up to 30,000 patients with nodules classified as Bethesda V annually, of which we assume approximately one-third will be covered under Medicare and Medicare Advantage. This is an important step in both expanding our market for Afirma, as well as furthering our leadership in endocrinology.

我們也在 6 月實現了一個重要的里程碑，MolDX 最終確定了擴大 Afirma 的本地覆蓋範圍，為患有 Bethesda V 甲狀腺結節的 Medicare 和 Medicare Advantage 患者增加對疑似癌症患者的報銷。每年有多達 30,000 名患有 Bethesda V 結節的患者，我們假設其中大約三分之一將受到 Medicare 和 Medicare Advantage 的承保。這是擴大 Afirma 市場以及進一步鞏固我們在內分泌學領域領導地位的重要一步。

Our confidence in continued growth driven by Decipher and Afirma has only increased with this quarter's outstanding performance. With durable market share gains, further penetration into existing accounts, expanded indications, and more use cases in our available market, we are making progress towards the 80% penetration for both prostate and thyroid cancer molecular tests from 35% and 60%, respectively, coming into the year.

隨著本季的出色表現，我們對 Decipher 和 Afirma 推動的持續成長的信心進一步增強。隨著市場份額的持續增長、對現有客戶的進一步滲透、適應症的擴大以及可用市場中更多用例的增加，我們正在向前列腺癌和甲狀腺癌分子檢測的滲透率分別從35% 和60%邁向80%，進入今年。

Further, paired with the ASP improvements in the Decipher and Afirma volume catalyst delivered this year so far, there is compelling evidence that we are trying to continue to deliver robust revenue growth for the foreseeable future, near term, midterm and even long term, especially in the case of Decipher. We plan on underpinning this growth with continued profitability and cash generation while also investing in future innovation.

此外，結合今年迄今交付的Decipher 和Afirma 銷量催化劑中平均售價的提高，有令人信服的證據表明，我們正在努力在可預見的未來、近期、中期甚至長期內繼續實現強勁的收入增長，特別是在破解的情況下。我們計劃透過持續的獲利能力和現金生成來支撐這一成長，同時也投資於未來的創新。

With that, I will now turn to Rebecca to review our financial results for the quarter and heightened expectations for 2024.

接下來，我將請麗貝卡回顧我們本季的財務業績，並提高對 2024 年的預期。

Thanks, Marc. Q2 was a fantastic quarter with $114.4 million in revenue, an increase of 27% over the-prior year period. We grew total volume to approximately 39,000 tests, a 23% increase over the same period in 2023. Testing revenue during the quarter was $107 million, an increase of 31% year over year, driven by Decipher and Afirma volume along with ASP growth. Total testing volume was approximately 36,000 tests.

謝謝，馬克。第二季度是一個出色的季度，營收為 1.144 億美元，比上年同期成長 27%。我們的測試總量增加至約 39,000 次，比 2023 年同期成長了 23%。在 Decipher 和 Afirma 銷量以及 ASP 成長的推動下，本季測試營收為 1.07 億美元，較去年同期成長 31%。總測試量約為 36,000 次測試。

Testing ASP was approximately $2,950, which included approximately $4 million of prior-period collections. It is important to recognize that while these adjustments are for tests delivered in prior periods, this result is driven by sustainable efficiencies in our billing and collections processes. Adjusting for the impacts in the quarter, testing ASP would have been approximately $2,850.

測試平均售價約為 2,950 美元，其中包括約 400 萬美元的前期收款。重要的是要認識到，雖然這些調整是針對前期交付的測試，但這一結果是由我們的計費和收款流程的可持續效率所驅動的。調整本季的影響後，測試平均售價約為 2,850 美元。

Second-quarter product volume was approximately 3,000 tests, and product revenue was $3.9 million. We continue to expect supply chain issues to suppress supply of the Prosigna nCounter test in the second half of this year and perhaps beyond. Biopharmaceutical and other revenue was $3.6 million, down 22% year over year.

第二季產品量約 3,000 次測試，產品收入為 390 萬美元。我們仍然預計，供應鏈問題將在今年下半年甚至更長時間內抑制 Prosigna nCounter 測試的供應。生物製藥及其他收入為 360 萬美元，年減 22%。

Moving to gross margin and operating expenses, I will highlight our non-GAAP results. Our non-GAAP metrics exclude where applicable, the amortization of acquired intangible assets, stock-based compensation, other acquisition-related expenses, restructuring costs, and certain other adjustments. Non-GAAP gross margin was 71%, up approximately 350 basis points compared to the prior-year period. Testing gross margin was 74%, up 250 basis points compared to the prior-year period due to ASP improvements and prior period cash collections. Product margin was 52% due to favorable manufacturing variances. With investments in service support in the second half of the year, we expect product margin to be below historical averages.

談到毛利率和營運費用，我將重點放在我們的非公認會計準則績效。我們的非公認會計準則指標不包括適用的收購無形資產攤提、股票薪資、其他收購相關費用、重組成本和某些其他調整。非 GAAP 毛利率為 71%，較上年同期成長約 350 個基點。由於平均售價提高和前期現金回籠，測試毛利率為 74%，較上年同期成長 250 個基點。由於有利的製造差異，產品利潤率為 52%。隨著下半年對服務支援的投資，我們預期產品利潤率將低於歷史平均水準。

Biopharmaceutical and other gross margin was negative 4%, down year over year due to lower fixed cost absorption. In July, we executed our voluntary reduction plan in Marseille, which is expected to benefit our cost structure going forward. However, given our anticipated second-half revenue, we expect full-year biopharma and other gross margin to be at or slightly below the second-quarter level.

由於固定成本吸收較低，生物製藥及其他毛利率為負 4%，較去年同期下降。7月份，我們在馬賽執行了自願削減計劃，預計這將有利於我們未來的成本結構。然而，考慮到我們預計的下半年收入，我們預計全年生物製藥和其他毛利率將達到或略低於第二季的水平。

Non-GAAP operating expenses were up 14% year over year to $59 million. Research and development expenses increased by $3.5 million to $14.6 million, given personnel additions with the C2i acquisition and increased costs related to our NIGHTINGALE clinical studies. Sales and marketing expense declined by $800,000 to $21.9 million due to lower personnel costs from the Envisia sales force reduction, partially offset by higher commissions. G&A expenses were up $4.7 million to $22.6 million, driven by higher variable compensation given our updated full year outlook and other personnel costs.

非 GAAP 營運費用年增 14% 至 5,900 萬美元。由於 C2i 收購帶來的人員增加以及 NIGHTINGALE 臨床研究相關成本的增加，研發費用增加了 350 萬美元，達到 1,460 萬美元。由於 Envisia 銷售人員減少導致人員成本降低，銷售和行銷費用下降了 80 萬美元，至 2,190 萬美元，但部分被佣金增加所抵消。鑑於我們更新的全年展望和其他人員成本，可變薪酬較高，因此一般管理費用增加了 470 萬美元，達到 2,260 萬美元。

Moving to profitability metrics, as Marc shared, we are proud of our Q2 results. We recorded GAAP net income of $5.7 million, inclusive of a $3 million restructuring charge in relation to our Marseille location. We delivered adjusted EBITDA of $24 million, or 21% of revenue, well on our way towards our goal of sustained 25% adjusted EBITDA margins. We also generated $29.6 million of cash from operations and ended the quarter with $235.9 million of cash and cash equivalents.

正如 Marc 所說，轉向獲利能力指標，我們對第二季的業績感到自豪。我們的 GAAP 淨利潤為 570 萬美元，其中包括與馬賽辦事處相關的 300 萬美元重組費用。我們實現了 2,400 萬美元的調整後 EBITDA，即營收的 21%，正在朝著調整後 EBITDA 利潤率持續維持 25% 的目標邁進。我們也從營運中產生了 2,960 萬美元的現金，本季末現金和現金等價物為 2.359 億美元。

Turning now to our 2024 outlook. We are excited to raise our total revenue guidance to $432 million to $438 million from our prior guidance of $402 million to $410 million. This reflects a significant improvement in the outlook for our testing business with revenue growth of approximately 25%, a substantial increase compared to our prior guidance of 15% to 18%. We are also raising our cash guidance and expect to end 2024 with between $260 million to $270 million in cash, cash equivalents, and short-term investments.

現在轉向我們的 2024 年展望。我們很高興將總收入指引從先前的 4.02 億美元至 4.1 億美元提高到 4.32 億美元至 4.38 億美元。這反映出我們的測試業務前景顯著改善，營收成長約 25%，與我們先前 15% 至 18% 的指導相比大幅成長。我們也提高了現金指導，預計到 2024 年底，現金、現金等價物和短期投資將達到 2.6 億至 2.7 億美元。

Moving to the third quarter, we are forecasting a sequential decline in total revenue given typical seasonality and the impact of prior-year period cash collections in the second quarter. We expect Q4 revenue to be a sequential step up from Q3. Additionally, we anticipate adjusted EBITDA margins in the second half of the year to be slightly above the first half of the year, as we sustain our fiscal discipline.

進入第三季度，考慮到典型的季節性因素以及第二季度上年同期現金回收的影響，我們預計總收入將連續下降。我們預計第四季的營收將比第三季連續上升。此外，隨著我們維持財務紀律，我們預計下半年調整後的 EBITDA 利潤率將略高於上半年。

I am thrilled with our strong start to 2024 and our commitment to driving revenue growth with a focus on profitability and continued cash generation. I am further grateful for the contributions of all of our employees towards our vision of helping cancer patients globally.

我對 2024 年的強勁開局以及我們致力於推動收入成長、關注獲利能力和持續現金產生的承諾感到興奮。我還感謝我們所有員工為幫助全球癌症患者的願景所做的貢獻。

We'll now go into the Q&A portion of the call. Operator, please open the lines.

我們現在將進入電話會議的問答部分。接線員，請開通線路。

(Operator Instructions) Mason Carrasco, Stephens Inc.

（操作員說明）Mason Carrasco，Stephens Inc.

Hey, guys. Thanks for taking the questions here. Marc or Rebecca, could you remind us what steps you still need to take or go through, I guess, once this metastatic LCD is finalized in order to secure coverage and how you're thinking about the timeline there?

嘿，夥計們。感謝您在這裡提出問題。Marc 或 Rebecca，您能否提醒我們，一旦這種轉移性 LCD 最終確定，您仍需要採取或經歷哪些步驟以確保覆蓋範圍，以及您如何考慮那裡的時間表？

Yeah, happy to. So once we get the finalization from Palmetto, which will cover Noridian as well, we'll have to go through the tech assessment process, which will take a number of months. And then, obviously, we've got to train ourselves force and make sure we do a structured rollout as they work with physicians to make sure they understand the metastatic tests and how it's to be deployed. And then we've got to go through the billing process. So we think of this as a 2025 activity more so than 2024 with really starting in the first half and obviously ramping up as the year goes on. A reminder that there are roughly 30,000 patient incidences per year of metastatic that could apply here, and roughly two-thirds or so would be Medicare or Medicare Advantage. The other element of this is, of course, we'd have to work through commercial payers as well, and that takes a little bit longer.

是的，很高興。因此，一旦我們得到 Palmetto 的最終定稿（也將涵蓋 Noridian），我們就必須完成技術評估過程，這將需要幾個月的時間。然後，顯然，我們必須訓練自己的力量，並確保我們在與醫生合作時進行結構化的推廣，以確保他們了解轉移測試及其部署方式。然後我們必須完成計費流程。因此，我們認為這是一項 2025 年的活動，比 2024 年的活動更重要，從上半年開始，隨著時間的推移，活動明顯增加。提醒一下，每年約有 30,000 名患者發生轉移，這可能適用於此，其中約三分之二左右將屬於 Medicare 或 Medicare Advantage。當然，另一個因素是我們還必須透過商業付款人進行工作，這需要更長的時間。

And just to be abundantly clear on this, Mason, there's nothing currently embedded in our 2024 guide for metastatic.

梅森，為了清楚地說明這一點，我們的 2024 年轉移指南中目前沒有任何內容。

Perfect. Okay. That's helpful. And then on the cash generation during the quarter, the balance sheet is in great shape. Could you talk about how you're thinking about capital allocation going forward? What are some of the key internal investments you're making here? How does M&A fit in? Do you plan on adding commercial heads anywhere throughout the organization?

完美的。好的。這很有幫助。然後就本季的現金產生而言，資產負債表狀況良好。能談談您對未來資本配置的看法嗎？您在這裡進行的一些關鍵內部投資是什麼？併購如何調適？您是否計劃在整個組織的任何地方增加商業主管？

Yeah. If you think about organically the investments that we're making, we've been making all the investments that we feel like we need to make. We've been generating positive cash flow for a little while here. Obviously, this quarter was very strong. But we've not been holding back is probably the best way to say in terms of adding commercial teams. We're getting tremendous leverage out of the commercial team. We've got every sales rep we need. We're adding a couple here and there, wherever we need to launch new territories.

是的。如果你有機地考慮我們正在進行的投資，我們一直在進行我們認為需要進行的所有投資。我們在這裡產生正現金流已經有一段時間了。顯然，本季表現非常強勁。但在增加商業團隊方面，我們並沒有猶豫，這可能是最好的說法。我們從商業團隊中獲得了巨大的影響力。我們擁有所需的每一位銷售代表。無論我們需要在哪裡推出新的地區，我們都會在這裡或那裡添加一些。

And then on the R&D side, we're investing in three long-term growth drivers and programs that each are roughly equal, give or take a few million dollars in terms of the investments that we're making in each of them. And together, they account for more than half of our R&D spend. So organically, I don't think our positive cash generation really changes much around our strategies and focus.

然後在研發方面，我們正在投資三個長期成長動力和項目，每個項目都大致相等，就我們在每個項目上的投資而言，都會給予或減少數百萬美元。它們合計占我們研發支出的一半以上。因此，從有機角度來看，我認為我們的正向現金產生並沒有真正改變我們的策略和重點。

In terms of M&A and that type of activity, again, I don't think it really changes much. We've always said the type of targets that we'd be interested in would be something that has a clear path to reimbursement and positive growth and revenue generation. We don't want to take on multiyear R&D projects. We've got enough of those that we're working on ourselves. And so, there's not a lot of, I'd say, suitable targets out there.

就併購和此類活動而言，我認為它並沒有真正改變太多。我們總是說，我們感興趣的目標類型是具有明確的報銷路徑、積極成長和創造收入的目標。我們不想承接多年的研發項目。我們已經有足夠的東西了，我們正在努力解決這些問題。因此，我想說，合適的目標並不多。

Having said that, we always kick the tires. We always take a look at whatever comes our way and given how well we've been performing and the strength of our balance sheet, as you can imagine, we get a lot of inbounds. So no change in our approach here, and we'll continue to positive generate positive cash flow going forward and deploy it. We're right in the middle or about to start our 2025 budgeting process, so we haven't even decided the capital allocation for next year.

話雖如此，我們總是踢輪胎。我們總是關注我們遇到的任何事情，考慮到我們的表現和資產負債表的實力，正如你可以想像的那樣，我們得到了很多入站。因此，我們的方法沒有改變，我們將繼續積極產生正現金流並進行部署。我們正處於或即將開始 2025 年預算流程，因此我們甚至還沒有決定明年的資本分配。

Understood. Thank you, guys.

明白了。謝謝你們，夥計們。

Thank you.

謝謝。

Thanks, Mason.

謝謝，梅森。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hello. This is Yuko on the call for Tejas. Thank you for taking our questions. With IP litigation increasingly coming into point of focus, particularly in light of TwinStrand IP licensing by Exact Sciences, what are the implications, if any, for your MRD portfolio strategy? Could we see you participate in any patent pool sharing along the lines of what we saw between Personalis and Myriad recently?

你好。我是 Yuko，正在為光輝號通話。感謝您接受我們的提問。隨著智慧財產權訴訟日益成為人們關注的焦點，特別是考慮到 Exact Sciences 的 TwinStrand 智慧財產權許可，這對您的 MRD 投資組合策略有何影響（如果有）？我們能否看到你們參與任何專利池共享，就像我們最近在 Personalis 和 Myriad 之間看到的？

Yeah. Great question. As you know, we acquired our C2i business in early this part of this year. And as we mentioned, when we did that, we took a very specific approach of looking for an asset that is a whole genome-based approach because, really, primarily, it fits with our Veracyte Diagnostic platform of more data is better. And so, for every time you run the sample, you get a whole genome. And you'll see -- you've seen us leverage that kind of approach with Decipher now Afirma with GRID. So that was the primary purpose.

是的。很好的問題。如您所知，我們在今年年初收購了 C2i 業務。正如我們所提到的，當我們這樣做時，我們採取了一種非常具體的方法來尋找基於全基因組的方法，因為實際上，主要的是，它適合我們的Veracyte 診斷平台，數據越多越好。因此，每次運行樣本時，您都會獲得整個基因組。您會看到 - 您已經看到我們在 Decipher 中利用了這種方法，現在在 Afirma 中使用了 GRID。這就是主要目的。

Secondarily, of course, we looked at the freedom to operate in the IP landscape, and that approach gives us a lot more room than, I think, some of the targeted approaches that you're seeing a lot of this activity around. And so, we don't feel. We don't believe that, that is a -- I mean, you never know, but we don't believe that, that is an area of concern for us because specifically of the approach that we've taken. Going forward, I don't think there's necessarily any need for us to get involved in patent pools and so on, and we'll see where this -- how this whole space evolves over time.

其次，當然，我們著眼於在智慧財產權領域運作的自由，我認為這種方法為我們提供了比您在許多此類活動中看到的一些有針對性的方法更多的空間。所以，我們沒有感覺。我們不相信，這是一個——我的意思是，你永遠不知道，但我們不相信，這是我們所關注的一個領域，因為特別是我們所採取的方法。展望未來，我認為我們不一定需要參與專利池等，我們將看看這整個領域如何隨著時間的推移而演變。

Got it. Thank you for that. And with respect for Bethesda V for Afirma, with about a third of the population coming from Medicare, how quickly do you think that commercial payers could come on board following the reimbursement. Have you started to have discussions with payers already?

知道了。謝謝你。尊重 Afirma 的 Bethesda V，大約三分之一的人口來自醫療保險，您認為商業付款人在報銷後多久可以加入。您已經開始與付款人討論了嗎？

Yeah. I mean, over a period of time, there has already been some element of commercial payers paying for Bethesda V, so now, Medicare has caught up with that. And then there are some that are obviously now with the LCD, we're able to go to those commercial payers and leverage that to try and drive an update in policy. So we'll continue that activity. It takes a long time. There's a lot to go and do a lot of blocking and tackling and there are other big priorities, too. So Bethesda V, remember, is about 30,000 patients. So we're getting some of that already.

是的。我的意思是，在一段時間內，已經有一些商業付款人為 Bethesda V 付費，所以現在，醫療保險已經趕上了這一點。然後有一些顯然現在已經有了 LCD，我們可以聯繫那些商業付款人並利用它來嘗試推動政策更新。所以我們將繼續這項活動。這需要很長時間。還有很多事情要做，要做很多阻擋和鏟球工作，還有其他重要的優先事項。請記住，Bethesda V 約有 30,000 名患者。所以我們已經得到了一些。

Yeah. And I was just going to add, in the volume number that we cite for Afirma, the Bethesda V samples are included in that, that are being run and reimbursed for or better being run for Afirma at this point in time. And then the commercial component is also embedded in that ASP for Afirma. So just you can have an understanding of where we're at.

是的。我只是想補充一點，在我們為 Afirma 引用的捲號中，Bethesda V 樣本包含在其中，這些樣本正在運行並報銷，或者最好在此時為 Afirma 運行。然後，商業組件也嵌入 Afirma 的 ASP 中。這樣您就可以了解我們的處境。

Got it. Thank you very much.

知道了。非常感謝。

Thanks.

謝謝。

Andrew Brackman, William Blair.

安德魯·布拉克曼，威廉·布萊爾。

Hi, everyone. This is Maggie Boeye on for Andrew today. Thank you for taking our questions. Maybe just to start on the Decipher front, just as you think about the levers of growth in the back half of the year and into 2025, how much of that should come from elevated incidents versus account penetration and then versus share gains?

大家好。這是瑪吉·博耶今天為安德魯做的節目。感謝您接受我們的提問。也許只是從 Decipher 方面開始，正如您考慮下半年到 2025 年的成長槓桿一樣，其中有多少應該來自事件增加與帳戶滲透率，然後與份額收益相比？

Yeah, great question. I actually don't think it's really to do with incidents, although the incidences of prostate cancer are going up. If you look at some of the data there, it's kind of high-single-digit growth, and the incidence is, of course, metastatic for us enables us to target that entire $300,000 a year annual incidence of prostate cancer now, so it gives us the final piece of that puzzle.

是的，很好的問題。事實上，我認為這與事故無關，儘管前列腺癌的發生率正在上升。如果你看那裡的一些數據，你會發現這是一種高個位數的增長，而且發病率當然對我們來說是轉移性的，這使我們能夠現在將前列腺癌的年發病率目標定為30 萬美元，所以它給了我們就是這個拼圖的最後一塊。

What we're seeing and what we believe we're going to continue to see is both penetration in the market. If you remember at the beginning of this year, we said the market is about 35% penetrated. So there's a lot of white space to go after there. So further penetration in that market and even further share gains, it's pretty evident in the numbers that we're posting. We're seeing a combination of both and they're both significant drivers. And I do think, I mentioned this in the prepared remarks, but I do think the NCCN Level 1 the guidelines and the specific table around that are a significant driver of what we're seeing as a step function increase this quarter and maybe a new normal, too early to tell in terms of the growth curve. But certainly, it stepped up in Q2 like it did this time last year when we got the first NCCN.

我們所看到的以及我們相信我們將繼續看到的都是市場的滲透。如果你還記得今年年初，我們說過市場滲透率約 35%。所以那裡有很多空白需要追尋。因此，在該市場的進一步滲透，甚至進一步的份額增長，在我們發布的數據中非常明顯。我們看到兩者的結合，它們都是重要的驅動因素。我確實認為，我在準備好的發言中提到了這一點，但我確實認為 NCCN 1 級指南和具體表格是我們看到的本季階梯函數增加的重要驅動力，也許是一個新的正常，就成長曲線而言還為時過早。但可以肯定的是，它在第​​二季度有所加強，就像去年這個時候我們獲得第一個 NCCN 一樣。

So clearly, a significant factor in growth. And this is why we said plus, obviously, the ASP gains that Rebecca talked about, this is why we've said we feel very comfortable with the durability of the growth in Decipher.

很明顯，這是成長的一個重要因素。這就是為什麼我們說加上麗貝卡談到的 ASP 收益，這就是為什麼我們說我們對 Decipher 成長的持久性感到非常滿意。

Yeah. Absolutely. I was going to add in the ASP gains, but I think it's really important to note, Maggie, that we had two major catalysts for Decipher really present themselves over the course of the first quarter, which were manifested in the second quarter, which Marc cited. And I think those were really great wins for the internal teams, which drove both the publications and support of NCCN Level 1, and as well as the conversations with the major payer that we cited.

是的。絕對地。我本來打算加上平均售價的成長，但我認為，Maggie，值得注意的是，我們在第一季度中確實有兩個主要的催化劑，這在第二季度中得到了體現，Marc引用。我認為這些對內部團隊來說確實是巨大的勝利，它們推動了 NCCN Level 1 的出版物和支持，以及與我們引用的主要付款人的對話。

Great. Thanks so much. And then maybe just one on the pipeline, could you level set us on MRD and then just what we should be expecting in terms of catalysts and data generation for the MRD assay and just how we should be thinking about the next six quarters or so before it comes to market?

偉大的。非常感謝。然後也許只是一個正在醞釀中的項目，您能否為我們介紹一下 MRD，然後我們在 MRD 測定的催化劑和數據生成方面應該期待什麼，以及我們應該如何考慮接下來的六個季度左右它上市了嗎？

Yeah. Thanks for reminding us of the timing there. And remember, the MRD, our approach is while this is a platform, a whole genome platform that's going to address multiple indications. And you can imagine us thinking about the indications that we're currently in as well as new indications. We are starting with our first and it's more than a proof of concept, but think of it as a pilot MRD launch in muscle invasive bladder cancer. And so, we will launch that test in 2026.

是的。感謝您提醒我們那裡的時間。請記住，MRD，我們的方法是，雖然這是一個平台，一個將解決多種適應症的全基因組平台。您可以想像我們正在考慮當前的適應症以及新的適應症。我們從第一個計畫開始，它不僅僅是一個概念證明，而是將其視為肌肉浸潤性膀胱癌的 MRD 試點啟動。因此，我們將在 2026 年啟動該測試。

You will see us do -- we will suggest to do the tech assessment, get the reimbursement, again, train the sales force, very similar to what we talked about for Decipher metastatic. But we've got to run some samples there and do some of that activity, as well as setting up our CLIA lab regarding the automation, or we don't do whole genome today, so we have to ingest that into our lab. We do transcriptome today, so we're going to have to add that workflow and do the necessary activities around that. So that's why it takes a little bit longer to get that launched. And so, I think what we will probably share with you first is when we've done that tech assessment, and we're clearly seeing that path to reimbursement.

你會看到我們這樣做——我們會建議進行技術評估，獲得報銷，再次培訓銷售人員，這與我們在 Decipher 轉移中討論的非常相似。但我們必須在那裡運行一些樣本並進行一些活動，並建立我們的 CLIA 自動化實驗室，否則我們今天不會做整個基因組，所以我們必須將其納入我們的實驗室。我們今天進行轉錄組，因此我們必須添加該工作流程並圍繞該工作流程進行必要的活動。這就是為什麼啟動它需要更長的時間。因此，我認為我們可能首先與您分享的是當我們完成技術評估時，我們清楚地看到了報銷的途徑。

Great. Thank you so much.

偉大的。太感謝了。

Mike Matson, Needham & Company.

麥克馬森，李約瑟公司。

Hey, Marc and Rebecca. This is Joseph on for Mike. So I guess, first question, just around Afirma GRID. Marc, you talked about the three studies presented at ENDO in your prepared remarks. Just taking a look at those abstracts it seems like GRID is kind of powering some new discoveries in thyroid cancer research. I'm just wondering if any of those kind of molecular insights that have been found or could be found, could be implemented in an updated Afirma or an add-on clinical test in the future? Just kind of wondering how GRID RUO could progress in the future.

嘿，馬克和麗貝卡。這是麥克的約瑟夫。所以我想，第一個問題是關於 Afirma GRID 的。馬克，您在準備好的演講中談到了在 ENDO 上發表的三項研究。只要看一下這些摘要，GRID 似乎就為甲狀腺癌研究中的一些新發現提供了動力。我只是想知道已經發現或可能發現的任何此類分子見解是否可以在未來更新的 Afirma 或附加臨床測試中實施？只是想知道 GRID RUO 未來會如何發展。

Yeah, it's a great question, and I can draw comparisons here to Decipher and what we've seen there. But let me just start by reminding everybody that GRID is our whole transcriptome approach is fueled by the fact that we run a whole transcriptome. It's ordered roughly half of the time in both Afirma and Decipher's case.

是的，這是一個很好的問題，我可以將這裡與 Decipher 以及我們在那裡看到的東西進行比較。但首先我要提醒大家，GRID 是我們的整個轉錄組方法，它是由我們運行整個轉錄組這一事實所推動的。在 Afirma 和 Decipher 的案例中，大約有一半的時間是訂購的。

And it's clearly fueling new research, and you cited the three that came out at ENDO 2024. And included in that look things like new biomarkers or groups of biomarkers that people are doing analysis on, researchers are doing analysis on to determine there's correlations there, and that is really what we can do.

它顯然正在推動新的研究，您引用了 ENDO 2024 上發表的三項研究。其中包括人們正在分析的新生物標記或生物標記組之類的東西，研究人員正在進行分析以確定其中的相關性，這確實是我們能做的。

We've seen that actually with Decipher, where there have been some specific biomarkers that have been used multiple times, and I'm trying to remember the name [prostosis] is one of them in Decipher, where there have been a number of publications around that.

事實上，我們已經在 Decipher 中看到了這一點，其中有一些特定的生物標誌物已被多次使用，我正在努力記住名稱 [prostosis] 是 Decipher 中的其中之一，其中有許多出版物圍繞那個。

And so, I think you're going to see similar things with Afirma. It's really helping to renew investment and research around endocrinology and thyroid cancer; it's wonderful to see that. And so, whether those end up being commercial tests in the future is to be determined. But again, remember, from our standpoint, the fact that we run a whole transcriptome means we always have that data for every patient. So it will be nice to see some new tests in the future potentially, but I'll wait and see how that pans out.

因此，我認為您會在 Afirma 上看到類似的情況。這確實有助於更新內分泌學和甲狀腺癌的投資和研究；很高興看到這一點。因此，這些最終是否會在未來進行商業測試仍有待確定。但再次請記住，從我們的角度來看，我們運行整個轉錄組這一事實意味著我們始終擁有每個患者的數據。因此，很高興在未來看到一些新的測試，但我會等待，看看結果如何。

Okay, great. Yeah, that's very helpful. And then just maybe a quick one. Do you have an approximation for NIGHTINGALE in terms of data release for clinical utility or is that kind of too far out to put a quarter down or for an approximation?

好的，太好了。是的，這非常有幫助。然後也許只是一個快速的。在臨床實用性數據發布方面，您是否有 NIGHTINGALE 的近似值，或者這種近似值是否太遠，無法降低四分之一或近似值？

Yeah, too far out really to put a quarter down. It's one of our long-term growth drivers, as you know. And what we need to actually do is complete the study. That's step number one. Analyze the data at several points along the way. See when we have the clinical utility, take the refill that we have, take it to get it published, take it to MolDX, and go forward from there. And so, it's multiyears before we get to that point.

是的，太遠了，真的無法放下四分之一。如您所知，這是我們的長期成長動力之一。我們真正需要做的是完成研究。這是第一步。在此過程中分析多個點的數據。看看我們什麼時候有臨床實用性，拿走我們現有的補充，用它來發表，把它帶到 MolDX，然後從那裡繼續前進。因此，我們需要很多年才能達到這一點。

We're still enrolling for NIGHTINGALE at this point. We still got close to 100 sites enrolling. And as I said last quarter, I'm not going to predict when that finishes, but we're progressing.

目前我們仍在為 NIGHTINGALE 報名。我們仍然有近 100 個網站正在註冊。正如我上個季度所說，我不會預測何時結束，但我們正在取得進展。

Absolutely. Okay. Well, congrats on the quarter.

絕對地。好的。好吧，恭喜這個季度。

Great. Thank you.

偉大的。謝謝。

(Operator Instructions) Prashant Kota, Goldman Sachs.

（操作員指示）Prashant Kota，高盛。

Hey, guys. Congrats on the quarter, really strong results. A lot of questions have already been asked, but just going back to Afirma, how are you thinking about ASP trajectory given the addition of GRID and Bethesda V classification? So for example, once GRID is potentially becomes available for patients, as opposed to RUO, yeah.

嘿，夥計們。恭喜本季，業績非常強勁。很多問題已經被問到了，但回到 Afirma，考慮到添加了 GRID 和 Bethesda V 分類，您如何看待 ASP 軌跡？例如，一旦 GRID 可能可供患者使用，而不是 RUO，是的。

Maybe I'll tackle that last, and Rebecca, you can hit the ASP. But I see, GRID, as a research-use-only tool for the foreseeable future. I don't think that becomes a clinical tool. It could lead to, as we mentioned earlier, some clinical discoveries that end up in a clinical setting in the future. But I don't see that right now. It's Afirma clinical test as we have it and then the research use only GRID to power research. Rebecca?

也許我會最後解決這個問題，麗貝卡，你可以點擊 ASP。但我認為 GRID 在可預見的未來將是一種僅供研究使用的工具。我不認為這會成為一種臨床工具。正如我們之前提到的，它可能會帶來一些臨床發現，並在未來最終應用於臨床。但我現在還沒有看到這一點。這是我們擁有的 Afirma 臨床測試，然後研究僅使用 GRID 來推動研究。麗貝卡？

Yeah. So on the ASP front, obviously, the Bethesda V updated LCD is great news for us, as Marc highlighted in the script. And in parallel, obviously, the large payer on the Decipher side in the first quarter is also another positive trend for us on ASP. So when I think about ASP in general, I would like to think about it more at the total testing level and the high-level positive trends that we have to that end. We cited a 5% CAGR over the last two years on ASP.

是的。因此，在 ASP 方面，顯然，Bethesda V 更新的 LCD 對我們來說是個好消息，正如 Marc 在劇本中所強調的。同時，顯然，第一季 Decipher 方面的大支付者也是我們在 ASP 上的另一個積極趨勢。因此，當我總體上考慮 ASP 時，我會更多地在總體測試級別以及為此目的而採取的高級別積極趨勢上進行考慮。我們指出過去兩年 ASP 的複合年增長率為 5%。

I think when it comes down to it, these were the things that we need to continuously do to drive ASP growth above and beyond the volume growth that we're delivering. And so, you can do the rough math on a third of the 30,000 patients being the Medicare for Bethesda V and back into, if you assume whatever our penetration level is and share level is for Afirma, you come back into the actual dollar magnitude there. But it won't necessarily be hugely impactful, but it is another important driver, if you will, to that continued ASP gains over a multiyear period.

我認為歸根結底，這些是我們需要不斷做的事情，以推動 ASP 成長超過我們所交付的銷售成長。因此，您可以對 Bethesda V 的 30,000 名醫療保險患者中的三分之一進行粗略計算，然後返回，如果您假設 Afirma 的滲透水平和份額水平如何，您就會回到那裡的實際美元規模。但這不一定會產生巨大的影響，但如果你願意的話，它是另一個重要的驅動因素，可以推動平均售價在多年內持續成長。

Got it, that's really helpful. And then as far as evidence generation for your tests, are there any notable upcoming studies we should be aware of aside from NIGHTINGALE?

明白了，這真的很有幫助。然後，就測試的證據產生而言，除了 NIGHTINGALE 之外，我們還應該注意哪些即將進行的值得注意的研究？

Always. The level of activity around Decipher continues to be very, very broad. Studies that we're involved in as well as many studies, where we're aware of it, but we're not necessarily driving it and others are, again, fueled by GRID in many respects. And so you should expect to see more there. There's always a nice steady cadence of studies, and now I think that should pick up with GRID for Afirma.

總是。圍繞 Decipher 的活動水平仍然非常非常廣泛。我們參與的研究以及許多研究，我們都意識到了這一點，但我們不一定在推動它，而其他研究在許多方面都受到 GRID 的推動。所以你應該期待在那裡看到更多。研究的節奏總是很穩定，現在我認為 Afirma 的 GRID 應該會加快這種節奏。

And then in other indications between lung and breast, there's a lot of activities going on. So yeah, nothing that I would point to right now as specifically notable, just keep an eye on the steady rollout.

然後在肺部和乳房之間的其他適應症中，有很多活動正在進行。所以，是的，我現在沒有什麼特別值得注意的，只需專注於穩定的推出。

Great, thank you so much.

太好了，非常感謝。

Thomas DeBourcy, Nephron Research.

托馬斯·德布西，腎單位研究。

Hi. Thanks for taking the question. I was just wondering, I guess, kind of sort of a combination, the level of investment in C2i in the quarter or for the year and/or how are you kind of thinking about your adjusted EBITDA margin trajectory from here? I know you haven't given long-term guidance towards that margin, but obviously, the level of spend of C2i can obviously be a ceiling on that level. So any additional commentary you have in terms of how you balance those?

你好。感謝您提出問題。我只是想知道，我想，某種組合，本季度或全年對 C2i 的投資水平和/或您如何看待調整後的 EBITDA 利潤率軌跡？我知道您沒有就該利潤率給出長期指導，但顯然，C2i 的支出水平顯然可以成為該水平的上限。那麼對於如何平衡這些，您還有什麼其他評論嗎？

Yeah. Great question. Glad you brought that up. If you think about C2i, one thing that is important to note is we certainly didn't take on the burn run rate of the company as a standalone company because we're adopting a very different approach to how we're utilizing that MRD capability and platform. We've already kicked off our first project product, if you like, as we talked about earlier. And so, what happened is we now have legacy Veracyte team members working very closely with the C2i team on that project. And we have C2i team members working on other Veracyte projects. So those expenses have become very blended. And so, we don't even talk about or think about the C2i expense run rate or burn anymore. It's just now part of Veracyte.

是的。很好的問題。很高興你提出來。如果您考慮 C2i，需要注意的一件事是，我們當然沒有將公司作為獨立公司的燒毀運行率考慮在內，因為我們採用了一種非常不同的方法來利用 MRD 功能和平台。如果您願意的話，我們已經啟動了我們的第一個專案產品，正如我們之前討論的那樣。因此，現在我們的舊 Veracyte 團隊成員與 C2i 團隊在該專案上密切合作。我們還有 C2i 團隊成員參與其他 Veracyte 專案。因此，這些費用變得非常複雜。因此，我們甚至不再談論或考慮 C2i 費用運行率或燒錢。它現在只是 Veracyte 的一部分。

If you think about that investment in MRD, which is really the bulk of what the C2i team brought to the table, that is, as I said earlier, there are three big projects. It's MRD, it's the nasal swab with our NIGHTINGALE study in particular, and then it's our three IVD projects or products that we're launching.

如果你考慮一下對 MRD 的投資，這實際上是 C2i 團隊帶來的大部分資金，也就是說，正如我之前所說，共有三個大項目。它是 MRD，它是鼻拭子，特別是我們的 NIGHTINGALE 研究，然後是我們正在推出的三個 IVD 項目或產品。

If you take each of those, they're roughly similar in size, give or take a couple of million dollars either way. And together, all three make up more than half of our total R&D spend. So yeah, I don't see a significant change in the trajectory of spend that we've been tracking for R&D given that acquisition or anything else. And then I'll let Rebecca --

如果你把每一個都拿出來，你會發現它們的大小大致相似，或多或少都會有幾百萬美元。這三者合計占我們研發總支出的一半以上。所以，是的，考慮到這次收購或其他任何事情，我認為我們一直在追蹤的研發支出軌跡沒有發生重大變化。然後我會讓麗貝卡--

Yeah. So I think that plays very nicely into the adjusted EBITDA look forward perspective as well, Thomas. I think Marc highlighted that we don't see meaningful changes in such trajectory. That being said, we also commented in our prepared remarks that the second half would -- that adjusted EBITDA in the second half would be slightly higher than the adjusted EBITDA in the first half and that we're going into our 2025 budgeting season. And so, therefore, we can't necessarily comment on when or the duration to get to that 25% adjusted EBITDA goal. But obviously, we're headed in the right direction. We're incredibly proud of the portfolio approach we take to managing this company. And philosophically, I don't think anything will change on a go-forward basis. In any given year, you can obviously have puts and takes, but we've abided by the philosophy now for many, many years, both here and elsewhere, and I don't foresee that changing.

是的。所以我認為這對調整後的 EBITDA 前景也有很好的影響，托馬斯。我認為馬克強調我們沒有看到這種軌跡發生有意義的變化。話雖如此，我們還在準備好的演講中評論道，下半年調整後的 EBITDA 將略高於上半年調整後的 EBITDA，而且我們將進入 2025 年預算季節。因此，我們不一定能評論何時或需要多長時間才能實現 25% 調整後 EBITDA 目標。但顯然，我們正朝著正確的方向前進。我們對管理這家公司所採用的投資組合方法感到非常自豪。從哲學上講，我認為未來不會有任何改變。在任何一年，你顯然都可以有看跌期權和看跌期權，但我們已經遵守這一理念很多很多年了，無論是在這裡還是在其他地方，我預計這種情況不會改變。

Thanks. I do want to just punctuate that. The 21% adjusted EBITDA for the quarter, I think, is a significant milestone for us, and it's great to see it into what we've been heading towards that kind of a level of profitability and growth. And it's about, I think it's about 600 basis points higher than we achieved in Q1. So really, really impressed to see that and it's certainly something that we want to sustain and grow from.

謝謝。我確實想強調這一點。我認為，本季 21% 的調整後 EBITDA 對我們來說是一個重要的里程碑，很高興看到我們一直在朝著這種盈利和增長水平邁進。我認為這比我們第一季實現的目標高出約 600 個基點。看到這一點真的非常非常令人印象深刻，這當然是我們想要維持和成長的東西。

Thank you.

謝謝。

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Marc for closing remarks.

謝謝。我目前沒有提出任何進一步的問題。現在我想請馬克做結束語。

Thank you, Lauren. I appreciate it. So in closing, I believe that our Decipher revenue growth of 43% year over year, Afirma revenue growth of 21% year over year, our 21% adjusted EBITDA margin, and almost $27 million of cash generation in the quarter sets us apart. After that, the durable growth in both tests that we're experiencing and our three incremental long-term growth drivers, Veracyte clearly has a very unique profile in the diagnostics industry that is not getting the attention, I believe, is warranted at the space. Molecular diagnostics proving their value when supported by evidence, and I believe that Veracyte is leading that charge.

謝謝你，勞倫。我很感激。因此，最後，我相信我們的 Decipher 收入同比增長 43%，Afirma 收入同比增長 21%，調整後 EBITDA 利潤率為 21%，以及本季度近 2700 萬美元的現金產生，使我們與眾不同。之後，我們正在經歷的兩項測試的持久增長以及我們三個增量長期增長驅動力，Veracyte 顯然在診斷行業中擁有非常獨特的形象，我相信，在該領域沒有得到關注是有道理的。當有證據支持時，分子診斷就會證明其價值，我相信 Veracyte 正在引領這一潮流。

I want to thank all the approximately 850 employees at Veracyte who have contributed to this excellent performance over many years to make a difference in the lives of over 500,000 patients that we have served to date with our advanced diagnostic tests. I look forward to updating you again on our Q3 earnings call. Thank you.

我要感謝 Veracyte 的所有約 850 名員工，多年來他們為這一出色的業績做出了貢獻，使我們迄今為止通過先進的診斷測試服務的超過 500,000 名患者的生活發生了變化。我期待在第三季財報電話會議上再次向您通報最新情況。謝謝。

Ladies and gentlemen, this concludes our call today. Thank you for joining us. You may now disconnect.

女士們、先生們，我們今天的通話到此結束。感謝您加入我們。您現在可以斷開連線。