Veracyte Inc (VCYT) 2024 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Veracyte fourth quarter and full year 2024 financial results webcast. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎收聽 Veracyte 2024 年第四季和全年財務業績網路廣播。（操作員指示）請注意，今天的會議正在錄音。

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

現在，我想將會議交給今天的發言人、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 fourth-quarter and full year 2024 financial results. With me today are Marc Stapley, Veracyte's Chief Executive Officer; and Rebecca Chambers, our Chief Financial Officer.

大家下午好，感謝您今天加入我們討論我們的 2024 年第四季和全年財務業績。今天和我一起出席的是 Veracyte 執行長 Marc Stapley；以及我們的財務長 Rebecca Chambers。

Veracyte issued a press release earlier this afternoon detailing our fourth-quarter and full year 2024 financial results. This release and a copy of the presentation we will review during the call today are available in the Investor Relations section of our website at veracyte.com.

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 年第四季和全年的財務表現。本新聞稿和我們將在今天的電話會議上審查的簡報的副本可在我們網站 veracyte.com 的投資者關係部分找到。

Before we begin, I'd like to remind you that various statements we 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.

在我們開始之前，我想提醒您，我們在本次電話會議中所做的各種聲明將包括適用證券法所定義的前瞻性聲明。前瞻性陳述受風險和不確定性的影響，公司不能保證其正確性。此外，我們沒有義務提供本季業務趨勢或業績的進一步更新。

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. 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.

為了更了解可能導致實際結果不同的風險和不確定性，我們請您參閱 Veracyte 向美國證券交易委員會提交的文件，包括 Veracyte 最新的 10-Q 表和 10-K 表。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 財務指標的對帳包含在今天的收益報告中，可從 Veracyte 網站的 IR 部分存取。

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

現在我將把電話轉給 Veracyte 的執行長 Marc Stapley。

Thank you, Shayla, and thanks, everyone, for joining us today. 2024 was a record year for Veracyte. I could not be more proud of our team for their hard work on behalf of the patients we serve, which is the reason we come to work every day. Not only did their focus and dedication lead to approximately 150,000 patients benefiting from the information provided by our tests, it also enabled us to execute on our key strategic objectives and deliver a best-in-class financial profile. We capped off a record year with Q4 revenue totaling $119 million or 21% year-over-year growth.

謝謝你，Shayla，也謝謝大家今天加入我們。 2024 年是 Veracyte 創紀錄的一年。我為我們的團隊為我們服務的患者所做的努力感到無比自豪，這也是我們每天上班的原因。他們的專注和奉獻不僅使大約 150,000 名患者受益於我們測試提供的信息，還使我們能夠執行關鍵戰略目標並提供一流的財務狀況。我們以創紀錄的年度業績結束了第四季度，總收入達到 1.19 億美元，年增 21%。

This brought full year total revenue to $446 million for robust growth of 23% year over year. Testing revenue, which now accounts for almost 95% of our business, grew 28% year over year. Fourth quarter testing revenue increased 24% over the prior year and marked our 10th consecutive quarter of 20% or greater testing revenue growth, demonstrating the durability and runway of Afirma and Decipher that we have consistently signaled. And we drove class-leading bottom-line performance, delivering full-year adjusted EBITDA margin of 20.6% and cash generation of more than $70 million.

這使得全年總收入達到 4.46 億美元，年增 23%。測試收入目前占我們業務的近 95%，年增 28%。第四季的測試收入比去年同期成長了 24%，這是我們連續第 10 個季度實現 20% 或更高的測試收入成長，證明了我們一直強調的 Afirma 和 Decipher 的持久性和發展潛力。我們實現了業界領先的獲利業績，全年調整後 EBITDA 利潤率達到 20.6%，現金產生量超過 7,000 萬美元。

Starting with Decipher, we further strengthened our position as the market leader with outstanding adoption over the course of 2024 as we delivered more than 80,000 tests, representing volume growth of 36%.

從 Decipher 開始，我們透過 2024 年期間的出色採用進一步鞏固了我們的市場領先地位，我們進行了超過 80,000 次測試，數量增長了 36%。

During the fourth quarter, Decipher volume grew 45% year over year to a new record of more than 22,400 tests. We are particularly proud of our land-and-expand approach in prostate cancer, which has enabled us to go from an early beginning in RP only to adding biopsy almost a decade ago and growing that to be the vast majority of our testing today.

第四季度，Decipher 的測試量年增 45%，創下 22,400 多次測試的新紀錄。我們對我們針對前列腺癌的「落地並擴展」方法尤其感到自豪，這種方法使我們從早期的 RP 開始，到近十年前增加了活檢，並將其發展成為我們今天絕大多數的檢測。

In Q4, we saw 40% to 55% annual volume growth across each of the NCCN biopsy risk categories from low risk to intermediate risk and high risk. Importantly, low risk now represents an impressive 20% of our total Decipher volume. This is a testament to the value that Decipher brings to this population in better managing their disease from those that will benefit from active surveillance to those who have a worse prognosis and might need treatment.

在第四季度，我們發現 NCCN 活檢風險類別（從低風險到中度風險和高風險）的年增長率為 40% 至 55%。重要的是，低風險現在占我們 Decipher 總交易量的 20%。這證明了 Decipher 為這些人群帶來的價值，使他們能夠更好地管理自己的疾病，無論是從受益於主動監測的患者，還是預後較差、可能需要治療的患者。

As a demonstration of the clinical utility of Decipher in the NCCN low-risk population, based on our extensive real-world evidence, about one-third of those patients are reclassified to Decipher intermediate or high. Decipher's clinical validity and utility has already been demonstrated in approximately 85 clinical studies. This includes 42 on biopsy samples, more than a dozen of which could inform an active surveillance decision and 43 on radical prostatectomy. Since our last earnings call, we added 20 new publications, posters, abstracts and presentations highlighting the clinical utility for Decipher as well as incremental disease insights powered by Decipher GRID.

為了證明 Decipher 在 NCCN 低風險族群中的臨床實用性，根據我們廣泛的現實世界證據，大約三分之一的患者被重新歸類為 Decipher 中級或高級。Decipher 的臨床有效性和實用性已在約 85 項臨床研究中得到證實。其中包括 42 份活檢樣本，其中十幾份可以為主動監測決策提供信息，以及 43 份根治性前列腺切除術。自上次收益電話會議以來，我們增加了 20 份新出版物、海報、摘要和演示文稿，重點介紹了 Decipher 的臨床實用性以及由 Decipher GRID 提供支持的增量疾病洞察。

Looking ahead to further Decipher catalysts, we now estimate the growing prostate cancer market is approximately 40% penetrated, and we believe we have more than 65% market share, which we estimate increased by more than 500 basis points over the course of 2024.

展望進一步的 Decipher 催化劑，我們現在估計不斷增長的前列腺癌市場滲透率約為 40%，並且我們相信我們的市場份額超過 65%，我們估計到 2024 年這一比例將增加 500 多個基點。

As we have previously shared, our goal is to drive at least 80% market penetration in all of our indications. With the 2025 updated NCCN guidelines for prostate cancer, Decipher is still the only gene expression test with Simon Level 1 evidence, and we believe it's now the only gene expression test that is recommended by the NCCN panel to make personalized treatment decisions for prostate cancer patients.

正如我們之前所分享的，我們的目標是在所有適應症中實現至少 80% 的市場滲透率。隨著2025年更新的前列腺癌NCCN指南，Decipher仍然是唯一具有Simon 1級證據的基因表現檢測，我們相信它現在是唯一被NCCN專家組推薦用於為前列腺癌患者制定個人化治療決策的基因表現檢測。

Now to expanding Decipher to cover the entire risk spectrum for patients with prostate cancer, our metastatic technical assessment was approved in late December, and we secured New York state approval in January. We are well on our way to finalizing all the necessary commercialization and training activities to launch into this expanded population in the first half with volumes benefiting in the back half of 2025 and beyond.

現在，為了擴大 Decipher 的範圍，使其涵蓋前列腺癌患者的整個風險範圍，我們的轉移性技術評估已於 12 月底獲得批准，並於 1 月獲得了紐約州的批准。我們正在順利完成所有必要的商業化和培訓活動，以便在上半年將產品推向這一擴大的市場，並在 2025 年下半年及以後實現量產。

Given our leadership position, the expansion of Decipher into the metastatic patient population as well as significant greenfield opportunity ahead for our test in localized disease, we expect to drive meaningful Decipher growth for the foreseeable future.

鑑於我們的領導地位、Decipher 在轉移性患者群體中的擴展以及我們在局部疾病測試中面臨的重大綠地機會，我們預計在可預見的未來推動 Decipher 實現有意義的增長。

Moving to Afirma. Volume growth continues to be very strong and increased 12% in 2024. Despite the challenging Q4 comp, we delivered more than 16,300 tests during the fourth quarter, growing 8% year over year, while revenue grew 4%, given the large prior period collection in the fourth quarter of 2023. Deeper penetration into existing accounts, along with some sizable new customers drove the majority of growth in the quarter, a testament to Afirma's differentiated level of evidence, service and overall performance. As a reminder, an expanded LCD for Afirma went into effect in July 2024, adding reimbursement for Medicare and Medicare Advantage patients with Bethesda V thyroid nodules.

移至 Afirma。銷售成長持續強勁，到 2024 年將成長 12%。儘管第四季度的業績充滿挑戰，但我們在第四季度進行了超過 16,300 次測試，同比增長 8%，而由於 2023 年第四季度前期收集的數據量較大，收入增長了 4%。對現有帳戶的深入滲透以及一些規模可觀的新客戶推動了本季度的大部分增長，證明了 Afirma 差異化的證據、服務和整體表現水平。提醒一下，Afirma 的擴展 LCD 將於 2024 年 7 月生效，增加了對患有 Bethesda V 甲狀腺結節的 Medicare 和 Medicare Advantage 患者的報銷。

Revenue for Bethesda V and VI grew more than 80% year over year in the fourth quarter. We expect this to be a moderate ASP tailwind in 2025 as the clinical utility is further developed and resonates more with physicians.

Bethesda V 和 VI 第四季的營收年增超過 80%。我們預計，隨著臨床實用性的進一步發展以及與醫生的更多共鳴，這將成為 2025 年 ASP 的溫和順風。

Meanwhile, the research use-only GRID data is driving interest in evidence generation from the KOL and academic community. We look forward to sharing a number of upcoming publications and poster presentations leveraging this data in 2025 as we continue to build on our commitment to patients and physicians to advance thyroid cancer research. The endocrinology market is still only about 65% penetrated as of the beginning of 2025, and we estimate is growing in the low single digits.

同時，僅供研究使用的 GRID 數據正在激發 KOL 和學術界對證據生成的興趣。我們期待在 2025 年分享一系列利用這些數據的出版品和海報展示，因為我們將繼續履行對患者和醫生的承諾，推進甲狀腺癌研究。截至 2025 年初，內分泌學市場滲透率仍僅為 65% 左右，我們估計成長率將達到個位數。

We believe Afirma grew share in 2024, continues to serve the majority of the market and will make gains in both share and penetration to deliver strong revenue growth of high single digits this year. We are confident that Decipher and Afirma have ample growth runway ahead to bridge us to our longer-term growth drivers, which I will discuss next.

我們相信，Afirma 的市場份額將在 2024 年增長，繼續服務於大部分市場，並將在市場份額和滲透率方面取得增長，從而在今年實現高個位數的強勁收入增長。我們相信，Decipher 和 Afirma 擁有充足的成長空間，可以幫助我們實現更長期的成長動力，我將在下文中討論。

First, I'll start by providing a quick update on the status of our NIGHTINGALE study for nasal swab. To date, we have enrolled more than 85% of the 2,400 patients that we are targeting and look forward to sharing when enrollment is fully completed.

首先，我將簡單介紹一下我們的 NIGHTINGALE 鼻拭子研究的現況。到目前為止，我們已經招募了目標患者 2,400 名中的 85% 以上，並期待在招募工作全部完成後與大家分享。

Next, I'd like to provide an update on our efforts to serve more of the patient journey through MRD and recurrence testing. Our MRD approach is differentiated in that it is whole genome every step of the way, including the initial baseline sequencing followed by the sequencing of serial testing samples. This approach is backed by our fundamental belief that more data drives more insights, more clinical evidence, more payer coverage, and therefore, more durable adoption.

接下來，我想介紹我們透過 MRD 和復發檢測為更多患者提供醫療服務的最新進展。我們的 MRD 方法與眾不同之處在於，它的每一步都是全基因組，包括初始基線定序以及隨後的系列測試樣本定序。這種方法基於我們的基本信念：更多的數據可以帶來更多的見解、更多的臨床證據、更多的付款人覆蓋，從而帶來更持久的採用。

As we have shared, we are working on the first indication of our MRD platform for muscle invasive bladder cancer. This indication will leverage our strong Decipher channel that serves urologists and radiation oncologists. We are also focused on expanding into other indications where we already have a commercial presence.

正如我們所分享的，我們正在研究我們的 MRD 平台針對肌肉層浸潤性膀胱癌的第一個適應症。這一適應症將利用我們為泌尿科醫生和放射腫瘤學家服務的強大的 Decipher 管道。我們也致力於擴展到我們已經有商業存在的其他領域。

We have completed setting up the workflow in our lab and submitted for New York State approval. Further, we recently submitted to MolDx our proposed Z-Codes and expect to submit our tech assessment this quarter. These are critical steps for us to be able to launch and we're pleased with the progress we're making.

我們已經完成了實驗室工作流程的設定並提交給紐約州批准。此外，我們最近向 MolDx 提交了我們提議的 Z 代碼，並預計本季提交我們的技術評估。這些是我們啟動的關鍵步驟，我們對所取得的進展感到滿意。

As is our strategy across our platform, we are committed to having reimbursement in place and all development in managed care and commercial activities are progressing well so that we can launch our inaugural MRD test in the first half of 2026.

正如我們整個平台的策略一樣，我們致力於實現報銷，並且管理式醫療和商業活動的所有發展都在順利進行，以便我們能夠在 2026 年上半年推出首個 MRD 測試。

Finally, turning to our longer-term strategic growth driver of international expansion. Here, we are dedicated to launching our tests as IVDs to address patient needs outside the US. As you know, our French subsidiary, Veracyte SAS or SAS, has been focused on supporting our IVD strategy as well as a legacy biopharma and third-party contract development and manufacturing business.

最後，談談我們國際擴張的長期策略成長動力。在這裡，我們致力於推出 IVD 測試，以滿足美國以外的患者需求。如您所知，我們的法國子公司 Veracyte SAS 或 SAS 一直致力於支援我們的 IVD 策略以及傳統生物製藥和第三方合約開發和製造業務。

Given the declines in biopharma and our manufacturing and supply challenges for Prosigna, we believe that to continue to support such a large operation and infrastructure may be inconsistent with our core strategy and may not be in the best interest of Veracyte. Given this, we notified SAS that Veracyte, Inc. is considering no longer funding their operations.

鑑於生物製藥產業的衰退以及我們在 Prosigna 的製造和供應方面面臨的挑戰，我們認為繼續支持如此大規模的營運和基礎設施可能與我們的核心策略不一致，也可能不符合 Veracyte 的最佳利益。有鑑於此，我們通知 SAS，Veracyte, Inc. 正在考慮不再為其營運提供資金。

As a result, SAS will engage in consultation proceedings with the Work Council over the coming months, while in parallel seeking to identify one or more buyers for all or part of the SAS activities. Without Veracyte, Inc.'s continued funding or identification of a buyer, SAS may be required to commence bankruptcy proceedings this year.

因此，SAS 將在未來幾個月內與工會進行協商，同時尋求為 SAS 全部或部分活動尋找一個或多個買家。如果 Veracyte, Inc. 無法繼續提供資金或找不到買家，SAS 可能需要在今年啟動破產程序。

Consequently, Veracyte, Inc. would no longer own or operate the Marseille facility by year-end, if not sooner. Our first priority is to our patients, and so we will do our utmost to maintain continuity of Prosigna nCounter supply for the foreseeable future, which will depend in part on finding a buyer for this portion of the business.

因此，Veracyte 公司將在年底前（甚至更早）不再擁有或營運馬賽工廠。我們的首要任務是服務我們的患者，因此我們將竭盡全力在可預見的未來保持 Prosigna nCounter 供應的連續性，這在一定程度上取決於能否為這部分業務找到買家。

Further, we remain committed to our IVD strategy and our ongoing development programs. Having said that, this potential change is expected to impact our timelines, and we are diligently reassessing our development road maps.

此外，我們仍然致力於我們的 IVD 策略和我們正在進行的發展計劃。話雖如此，這種潛在的變化預計會影響我們的時間表，我們正在認真重新評估我們的發展路線圖。

In terms of the financial impact this year, this is, of course, highly dependent on the final outcome and the timing of that. Rebecca will share what she can to help you bracket the potential impacts. Our Marseille team has worked hard on behalf of customers and patients, and I truly appreciate their efforts. As we always do, we will compassionately support our employees during this information and consultation period.

就今年的財務影響而言，這當然在很大程度上取決於最終結果及其時機。麗貝卡將盡其所能幫助您應對潛在的影響。我們的馬賽團隊為了客戶和患者付出了辛勤的努力，我非常感謝他們的努力。正如我們一貫的做法，我們將在此資訊和諮詢期間熱情地支持我們的員工。

Despite these challenges in what is now a very small part of our business, I don't want to lose sight of the success we are having in the core business. As you can see, Q4 was another incredible quarter that capped off a truly exceptional year for Veracyte. My sincere thanks to our team for their relentless focus on our mission to serve patients. It is their hard work that sets us apart as we transform cancer care for patients around the world.

儘管這些挑戰目前只是我們業務中很小的一部分，但我並不想忽視我們在核心業務中的成功。如您所見，第四季度又是一個令人難以置信的季度，為 Veracyte 真正非凡的一年畫上了圓滿的句號。我真誠感謝我們的團隊堅持不懈地致力於為病人服務的使命。正是他們的辛勤工作使我們在為世界各地患者改變癌症治療方式的過程中脫穎而出。

This year, we are committed to continuing to deliver robust testing revenue growth as we execute on a number of key catalysts that will expand our reach both further along the patient journey and geographically. We look forward to sharing more details with you as we progress towards these goals.

今年，我們致力於繼續實現強勁的檢測收入成長，因為我們將實施一系列關鍵催化劑，以擴大我們在患者旅程和地理範圍內的影響力。我們期待在實現這些目標的過程中與您分享更多細節。

With that, I will now turn to Rebecca to review our financial results for the fourth-quarter and full-year 2024 as well as our outlook for 2025.

現在，我將請麗貝卡回顧我們 2024 年第四季和全年的財務表現以及 2025 年的展望。

Thanks, Marc. As mentioned, Q4 was a strong conclusion to 2024 as we delivered revenue of $118.6 million, an increase of 21% over the prior year period. Further, total volume grew to approximately 41,000 tests, a 22% increase over the same period in 2023. Testing revenue during the quarter was $112.2 million, an increase of 24% year over year, driven by Decipher and Afirma revenue growth of 44% and 4%, respectively. Total testing volume was approximately 39,100 tests.

謝謝，馬克。如上所述，第四季為 2024 年畫上了圓滿的句號，我們的營收達到 1.186 億美元，比去年同期成長了 21%。此外，總測試量成長至約 41,000 次，比 2023 年同期成長 22%。本季測試營收為 1.122 億美元，年增 24%，其中 Decipher 和 Afirma 營收分別成長 44% 和 4%。總測試量約為 39,100 次。

Testing ASP was approximately $2,875, which included approximately $600,000 of prior period collections. Adjusting for the impact in the quarter, testing ASP would have been approximately $2,850, up 4% compared with the prior year period.

測試 ASP 約為 2,875 美元，其中包括約 60 萬美元的前期收款。調整本季的影響後，測試平均售價約為 2,850 美元，較去年同期上漲 4%。

Turning to the product line. Fourth quarter volume was approximately 2,200 tests and revenue was $3 million, down 18% year-over-year as we continue to experience supply and manufacturing challenges while also managing demand for Prosigna. Biopharmaceutical and other revenue was $3.5 million, down 17% year over year.

轉向產品線。第四季的測試量約為 2,200 次，營收為 300 萬美元，年減 18%，因為我們繼續面臨供應和製造挑戰，同時還要管理對 Prosigna 的需求。生物製藥及其他收入為 350 萬美元，年減 17%。

Moving to gross margin and operating expenses, I will highlight our non-GAAP results. Non-GAAP gross margin was 69.3%, down approximately 130 basis points compared to the prior year period. Testing gross margin was 72.3%, down approximately 150 basis points due to the impact of approximately $4 million of lower prior period collections compared with the same period in 2023. Product gross margin was 7.3%, down materially from the prior year period due to lower fixed cost absorption and manufacturing challenges. Biopharmaceutical and other gross margin was 26.5%, up 9.4% year over year.

談到毛利率和營業費用，我將重點放在我們的非公認會計準則結果。非公認會計準則毛利率為 69.3%，較去年同期下降約 130 個基點。測試毛利率為 72.3%，由於與 2023 年同期相比，前期收款減少約 400 萬美元的影響，下降了約 150 個基點。產品毛利率為 7.3%，由於固定成本吸收減少和製造挑戰，較去年同期大幅下降。生物製藥及其他毛利率為26.5%，較去年成長9.4個百分點。

Non-GAAP operating expenses were flat year-over-year at $57.9 million. Research and development expenses increased by $0.2 million to $17.4 million, given personnel additions from our C2i acquisition and increased development costs, partially offset by the NextSeqDx IVD technology access fee that was recognized in Q4 2023. Sales and marketing expenses increased by $0.2 million to $23 million. G&A expenses were down $0.3 million to $17.6 million, driven by lower compensation expense, partially offset by infrastructure investments. Moving to profitability metrics, our financial profile continues to be best-in-class, driven by our disciplined approach.

非公認會計準則營業費用與去年同期持平，為 5,790 萬美元。由於我們收購 C2i 增加了人員並且開發成本增加，研發費用增加了 20 萬美元，達到 1,740 萬美元，但 2023 年第四季度確認的 NextSeqDx IVD 技術使用費部分抵消了這一影響。銷售和行銷費用增加了 20 萬美元，達到 2,300 萬美元。一般及行政開支下降 30 萬美元至 1,760 萬美元，原因是薪資開支減少，但基礎設施投資部分抵銷了這一影響。轉向獲利指標，在我們嚴謹的方法的推動下，我們的財務狀況繼續保持最佳水平。

In the fourth quarter, we recorded GAAP net income of $5.1 million and delivered adjusted EBITDA of $26.1 million or 22% of revenue. Full year 2024 adjusted EBITDA margin was in line with our guidance of over 20% at 20.6%. We ended 2024 with $289.4 million of cash and cash equivalents, generating over $70 million of cash driven by $75 million of cash from operations. During the fourth quarter, we made an election to treat Veracyte SAS as a disregarded entity for U.S. federal income tax purposes, resulting in a $356 million worthless stock deduction.

第四季度，我們的 GAAP 淨收入為 510 萬美元，調整後 EBITDA 為 2,610 萬美元，佔營收的 22%。2024 年全年調整後 EBITDA 利潤率符合我們 20% 以上的預期，達到 20.6%。截至 2024 年，我們的現金及現金等價物為 2.894 億美元，其中經營活動產生的現金超過 7,000 萬美元，其中經營活動產生的現金為 7,500 萬美元。在第四季度，我們選擇將 Veracyte SAS 作為美國聯邦所得稅目的的忽略實體，從而扣除了 3.56 億美元的無價值股票。

Given this, our Q4 GAAP effective tax rate was minus 48.5%. Our full year 2024 tax rate was 6.2% and exiting 2024, our NOLs available to offset U.S. future income now stands at more than $600 million. Before moving to our outlook for 2025, I would like to provide you with additional information regarding the France business. Please bear in mind that we are subject to a strict legal process and so are somewhat limited in what we can share.

有鑑於此，我們第四季的 GAAP 有效稅率為-48.5%。我們 2024 年全年的稅率為 6.2%，到 2024 年底，我們可用於抵銷美國未來收入的淨營業收入 (NOL) 現已超過 6 億美元。在展望 2025 年之前，我想向您提供更多有關法國業務的資訊。請記住，我們受到嚴格的法律程序的約束，因此我們能夠分享的內容受到一定限制。

Biopharma and other revenue now runs at about $2 million per quarter, as does product revenue. Our fixed cost structure in France runs about $7 million per quarter, and our net operating losses are approximately $5 million per quarter. Revenue could be negatively impacted any time depending on our ability to continue servicing current customers, including through Prosigna production. Meanwhile, our cost structure will be positively impacted in the future if SAS completes a sale to a potential purchaser or finalizes bankruptcy proceedings. The timing of these events could occur in different quarters or not at all.

目前，生物製藥和其他收入每季約為 200 萬美元，產品收入也是如此。我們在法國的固定成本結構每季約為 700 萬美元，淨營運虧損每季約 500 萬美元。收入可能隨時受到負面影響，這取決於我們繼續為現有客戶提供服務的能力，包括透過 Prosigna 生產。同時，如果 SAS 完成向潛在買家的出售或完成破產程序，我們的成本結構將在未來受到正面影響。這些事件發生的時間可能在不同季度，或者根本不會發生。

This year, we are currently estimating onetime costs of up to $15 million. Going forward into 2026 and beyond, if this goes ahead, we would see an improvement in our annualized profit of approximately $13 million. Looking ahead to 2025, given the dynamic nature of the situation with our French entity, our guidance will highlight testing revenue and total company adjusted EBITDA margin for the year. We are forecasting testing revenue of $470 million to $480 million or 12% to 15% year-over-year growth. As a reminder, and as we shared on our Q3 call, we made the difficult decision to pause offering the Envisia CLIA test at the end of 2024.

今年，我們目前估計一次性成本高達 1500 萬美元。展望 2026 年及以後，如果這項計畫得以實施，我們的年利潤將增加約 1,300 萬美元。展望 2025 年，鑑於我們法國實體的情況的動態性質，我們的指導將重點放在當年的測試收入和公司調整後的 EBITDA 利潤率。我們預測測試收入將達到 4.7 億美元至 4.8 億美元，年增 12% 至 15%。提醒一下，正如我們在第三季電話會議上所分享的那樣，我們做出了一個艱難的決定，將在 2024 年底暫停提供 Envisia CLIA 測試。

Adjusting for the approximately $6 million revenue impact, testing growth would be 14% to 16%. For 2025, we are forecasting adjusted EBITDA margin to improve by approximately 100 basis points as we balance investment in organic revenue opportunities for long-term growth with enhancing our already best-in-class financial profile. Our guidance assumes 2025 GAAP and non-GAAP tax rate will be in the mid-to-high single-digits. Turning to the first quarter. We expect testing revenue to step down from Q4 given Afirma seasonality as well as lower product and biopharma revenue.

調整約 600 萬美元的營收影響後，測試成長率將達到 14% 至 16%。到 2025 年，我們預測調整後的 EBITDA 利潤率將提高約 100 個基點，因為我們在長期成長的有機收入機會投資與增強我們已經一流的財務狀況之間取得平衡。我們的指導假設 2025 年 GAAP 和非 GAAP 稅率將處於中高個位數。轉向第一季。考慮到 Afirma 的季節性以及產品和生物製藥收入的下降，我們預計測試收入將從第四季度開始下降。

With the annual reset of taxes and merit, as is typical, we expect Q1 adjusted EBITDA margin to be in the mid-teens. Further, due to standard first quarter personnel costs, we plan to use cash in Q1 before generating cash over the remainder of the year. In closing, I am proud of the tremendous strides we made in 2024 and together with the entire Veracyte team, committed to delivering to the strategic priorities we've set in 2025 and beyond. Further, I'm proud of this organization's focus on delivering what is best for all stakeholders. We do our best to balance this each and every day with patients as our purpose.

隨著年度稅收和績效的重新設定，正如通常情況一樣，我們預計第一季調整後的 EBITDA 利潤率將達到 15% 左右。此外，由於第一季的標準人員成本，我們計劃在第一季使用現金，然後在今年剩餘時間內產生現金。最後，我為我們在 2024 年取得的巨大進步感到自豪，並與整個 Veracyte 團隊一起致力於實現我們在 2025 年及以後設定的戰略重點。此外，我為該組織致力於為所有利益相關者提供最佳服務而感到自豪。我們每天都會盡力平衡這一點，以患者為中心。

We'll now turn to the Q&A portion of the call.

我們現在進入電話會議的問答部分。

(Operator Instructions)

（操作員指示）

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

I have two and I will just rattle through both of them here and then get back in the queue. The first is a higher-level question. 2024 was a really strong year for the company. You set testing expectations for 2025, taking out all the adjustments at levels that I think were well ahead of consensus expectations. So, in many ways, you're in a position of strength in what is a tough environment for the broader market and the group.

我有兩個問題，我將在這裡快速瀏覽一遍，然後回到隊列中。第一個是更高層次的問題。 2024 年對公司來說確實是強勁的一年。您設定了 2025 年的測試預期，並進行了所有調整，我認為這些調整的水平遠遠超出了普遍預期。因此，從許多方面來看，在對整體市場和集團而言都很艱難的環境中，你們都處於優勢地位。

I'm just wondering, Marc, if you would talk a little bit about how you balance the potential to maybe get more aggressive with either further investment in growth and/or capital deployment with really the desire and the need in this environment to continue improving margin and cash flow. How are you balancing those options and those levers you have to pull? So that's the first topic. The second is for Rebecca. Rebecca, I think the assumption for Afirma revenue growth is high single-digit growth this year.

馬克，我只是想知道，你是否可以稍微談談，你如何平衡可能採取更積極措施的潛力，無論是進一步投資於成長和/或資本部署，還是真正滿足在這種環境下繼續提高利潤率和現金流的願望和需求。您如何平衡這些選項以及您必須採取的措施？這是第一個主題。第二個是給麗貝卡的。麗貝卡，我認為 Afirma 今年的收入成長假設是高個位數成長。

I think that's what's embedded into guidance. Assuming I have that right, how much is expanded LCD coverage versus pricing or other levers contributing to growth within the Afirma franchise this year?

我認為這就是指導中所包含的內容。假設我說得沒錯，那麼擴大 LCD 覆蓋範圍與定價或其他槓桿相比，對今年 Afirma 特許經營的增長有多大貢獻？

Great. Thanks, Doug. Appreciate your questions. I'll take the first one and Rebecca will take the second. So, yes, I appreciate you pointing that out.

偉大的。謝謝，道格。感謝您的提問。我想要第一個，麗貝卡要第二個。是的，我很感謝你指出這一點。

I mean the -- 2024 has been an incredible year and it's clear it's driven by our core testing business and the growth of Decipher and Afirma. And we've been signaling for quite a while now that both products have plenty of runway. I cited the amount of kind of opportunity there is in the market to grow each further, then the opportunities to take share, even though we're coming from a position of strength there. And so, we feel confident that those two businesses or that core franchise bridges us to our long-term growth drivers. And we talk about three things that we're doing within the company, including our international expansion, our MRD platform and innovative tests like nasal swab.

我的意思是——2024 年是令人難以置信的一年，很明顯這是由我們的核心測試業務以及 Decipher 和 Afirma 的成長所推動的。我們一直在暗示，這兩款產品都有充足的發展空間。我列舉了市場上存在的各種進一步發展的機會，以及佔領市場份額的機會，儘管我們在那裡佔據了優勢地位。因此，我們相信這兩項業務或核心特許經營權將為我們帶來長期成長動力。我們討論了公司內部正在進行的三件事，包括我們的國際擴張、我們的 MRD 平台以及鼻拭子等創新測試。

And of course, as you can imagine, we're working on other things as well that we're not ready to get into at this stage. But there's a lot of things that we're focused on as a company, and I think what you've seen us announce today with, again, another step in our kind of portfolio rationalization work and our difficult decision, or rather than a decision, our recommendation or our desire to look at the further investment in France. We have continued that portfolio process, and as a consequence of that, if that goes ahead at some point, that might create opportunity for us to invest in other ways. And so this portfolio decision making process that we go through has been key to create opportunity so that we can both focus our company and focus our team and focus our investment in things that we think are going to drive a positive ROI for the company in the next few years, 5 years and even 10 years. So, we think very long term at Veracyte, and we're excited about the opportunities we have.

當然，正如您所想的，我們也在做其他事情，但目前我們還沒有準備好開始做這些事情。但作為一家公司，我們關注的事情有很多，我想您今天看到我們宣布了我們在投資組合合理化工作中邁出的又一步，以及我們的艱難決定，或者說是一個決定，我們的建議或我們希望考慮在法國進一步投資。我們一直在延續這個投資組合流程，因此，如果這個流程在某個時候繼續進行，這可能會為我們以其他方式進行投資創造機會。因此，我們經歷的這個投資組合決策過程對於創造機會至關重要，這樣我們就可以集中精力於我們的公司、我們的團隊，並將我們的投資集中在我們認為將在未來幾年、五年甚至十年為公司帶來正投資回報率的事情上。因此，我們對 Veracyte 有著非常長遠的考慮，並且對我們所擁有的機會感到非常興奮。

Capital deployment is the one lever we have as well. Obviously, coming from a position of strength in terms of generating positive cash flow gives us even greater opportunity there. So, lots for us to do. But right now, our team is very, very focused on the things that are right in front of us. We have to get through this consultation period with France.

資本部署也是我們的一個槓桿。顯然，在產生正現金流方面的優勢為我們提供了更大的機會。所以，我們有很多事情要做。但現在，我們的團隊非常非常專注於眼前的事。我們必須度過與法國的這個磋商期。

We have to get MRD launched, we have to get metastatic launched. We're doing things within the company to improve COGS. There's a lot in front of us right now, all very positive things and 1 or 2 things that we just have to get through and let the dust settle.

我們必須啟動 MRD，我們必須啟動轉移性治療。我們正在公司內部採取措施來改善 COGS。現在我們面前有很多事情，都是非常正面的事情，但有一兩件事我們只需要解決，然後讓塵埃落定。

Absolutely. And the other thing I would just add is the benefit of the structure of our P&L allows us to both enhance profitability over a multi-year period while also investing for those growth drivers that Marc mentioned and others that have not yet been mentioned. So, we're pretty excited about 2024 results, 2025 outlook and even beyond, all is headed in the right direction. To that end, Doug, on your question on Afirma, effectively, yes, you're correct, guidance does contemplate high single-digit growth for Afirma Given some of the -- given effectively the benefit of what we're seeing both competitively, incidence growth as well as kind of share gains, we are driving most of that through volume. There is not a huge ASP tailwind assumed in the Afirma guide for the year.

絕對地。我想補充的另一件事是，我們的損益表結構的好處是，我們既可以在多年內提高盈利能力，又可以投資於馬克提到的增長動力以及其他尚未提及的增長動力。因此，我們對 2024 年的業績、2025 年的展望甚至更遠的未來感到非常興奮，一切都朝著正確的方向發展。為此，道格，關於你對 Afirma 的問題，實際上，是的，你是對的，指導確實考慮到 Afirma 的高個位數增長，考慮到我們在競爭中看到的優勢，發生率增長以及份額增長，我們通過數量來推動其中的大部分。Afirma 指南中並未假設今年的 ASP 會出現巨大的順風。

So I think we're going to kind of continuously play our playbook here for Afirma, and that is continuously introduce new product introductions, whether that's through customer experience or new grid signatures, et cetera, get out there, pound the pavement, share what we're doing and execute as we have for that product for the last number of years now.

因此，我認為我們將持續為 Afirma 執行我們的策略，那就是不斷推出新產品，無論是透過客戶體驗還是新的網格簽名等，走出去，四處奔走，分享我們正在做的事情，並像過去幾年我們對該產品所做的那樣執行。

Mason Carrico, Stephens.

梅森·卡里科，史蒂芬斯。

I'll just keep it to one here. When it comes to guidance, could you give us some color around how you're thinking about metastatic revenue this year? I know you talked about the back half, but any incremental color around cadence or potentially the opportunity to pull that revenue forward this year?

我在這裡只保留一個。說到指導，您能否告訴我們您對今年轉移收入的看法？我知道您談到了後半部分，但是關於節奏的任何增量色彩或今年是否有可能提前實現收入成長的機會？

Maybe, Mason, I'll start and Rebecca can jump on in terms of guidance. But a reminder for everybody, the metastatic indication is about 30,000 new incidences a year, which is about 10% of the total market. We're very deliberate about our choice of language there around the second half of the year. We've still got work to do to get this launched. The hardest part of actually getting everything ready and approved is very much behind us.

也許，梅森，我先開始，麗貝卡可以提供指導。但要提醒大家的是，轉移性適應症每年新發病例約3萬例，約佔整個市場的10%。我們會在今年下半年非常慎重地選擇語言。為了推出這個產品，我們還有很多工作要做。實際上，讓一切準備就緒並獲得批准的最困難的部分已經過去了。

Now it's a lot of just blocking and tackling internally to get it done. And then that -- then we've got to go out to customers and really talk about the benefit of this test for patients in that setting. And so, in that regard, we're starting from ground zero there. And so you would expect a ramp as our sales teams do that. We also don't want to distract from a core localized business that's been growing fantastically as well.

現在，只需在內部進行大量阻止和處理即可完成任務。然後——然後我們必須走出去，真正地談論這種測試對那種環境下的患者的益處。因此，從這個方面來說，我們是零起點。因此，當我們的銷售團隊這樣做時，您可以預期銷售量的成長。我們也不想分散對同樣成長迅猛的核心在地化業務的注意力。

So, how we meter those two things and balance those two things is a really important part of the equation. So, given that, we've been very deliberate about this being more of an impact in the second half and accelerating it wouldn't necessarily be in our best interest. We're thinking about the long term, doing it right, launching it right, getting it right and having the most success with that for the benefit of patients.

因此，我們如何衡量這兩件事並平衡這兩件事是這個等式中非常重要的一部分。因此，有鑑於此，我們已經非常慎重地考慮這會在下半年產生更大的影響，而加速這一進程並不一定符合我們的最佳利益。我們正在考慮長遠的事情，正確地做事，正確地啟動，正確地完成，並取得最大的成功，以造福病人。

Absolutely. And on the guidance front, we have assumed a relatively small contribution given it will be the first 2 quarters of launch for that 30,000 patient population. So I think could there be upside to that? Potentially, but I think the bigger upside driver would be outperformance during the year on the core Decipher business. That could obviously be a piece of it.

絕對地。在指導方面，我們假設貢獻相對較小，因為對於這 30,000 名患者來說，這將是推出後的前兩個季度。那我認為這會有好處嗎？有可能，但我認為更大的上行動力是核心 Decipher 業務在今年的出色表現。這顯然是其中的一部分。

But I think given our projections for where volume is coming from and where volume growth is coming from this year, metastatic will be a multiyear growth driver more so than the second half of our 2025 growth driver. Mason, if you don't mind, maybe perhaps we can go into some of the sequential trends for guidance for the year, given the highlight of the second half with metastatic, that absolutely is the case. As is typical, we do expect Q1 seasonality. There's a couple of drivers to that. One is Afirma.

但我認為，根據我們對今年銷售來源和銷售成長來源的預測，轉移性治療將成為多年的成長動力，而不是 2025 年下半年的成長動力。梅森，如果你不介意的話，也許我們可以討論今年的一些連續趨勢，以提供指導，考慮到下半年轉移性的亮點，情況確實如此。正如通常情況一樣，我們確實預期第一季會出現季節性。造成這現象的原因有幾個。一個是Afirma。

Last year, obviously, we saw a step down in Afirma. We're expecting something similar this year. Also, we are not having -- going to have the benefit of Envisia revenue in the fourth -- in the first quarter, which was around $1 million in the fourth quarter. And then we did have a little bit more weather so far this year than we have had in prior years. The reason I cite this isn't because that has impacted order trends.

顯然，去年我們看到了 Afirma 的下滑。我們預計今年也會出現類似情況。此外，我們不會在第一季獲得 Envisia 的收入，該收入在第四季約為 100 萬美元。今年到目前為止的天氣確實比往年稍微好一點。我引用這一點的原因並不是因為這影響了訂單趨勢。

On the contrary, order trends are actually quite strong, but it has impacted effectively 3 days of samples getting to us. And we'll make that up within the first half, but it depends on whether or not -- [whether] kind of strains out from here on out, whether we make it up in the first quarter or so. So just want to make sure you all have the benefit of that information. We're incredibly excited about this year for Decipher, for Afirma, for kind of the strategic long-term growth drivers and what we're setting up for here. So, don't want to have some sequential trends be a surprise given those are effectively what we see every year.

相反，訂單趨勢實際上相當強勁，但它對樣品到達我們手中的 3 天產生了有效影響。我們會在上半年彌補這一損失，但這取決於從現在開始是否會出現壓力，以及我們是否能在第一季左右彌補這一損失。因此，我只是想確保大家都能從這些資訊中受益。我們對今年 Decipher 和 Afirma 的發展感到無比興奮，也對我們為之製定的策略性長期成長動力和計劃感到無比興奮。因此，我們不希望某些連續的趨勢令人感到意外，因為這些其實就是我們每年都會看到的。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

First one, just given the puts and takes on the NCCN, and first of all, very strong quarter here in Decipher volumes. Just want to understand NCCN contribution versus other factors that are contributing to that? And how do you expect that to play out in 2025? You have the advanced table as well. And also, in terms of -- overall, the penetration of Decipher is strong, is well established in the market.

首先，鑑於 NCCN 的利弊，首先，本季 Decipher 卷的表現非常強勁。只是想了解 NCCN 的貢獻以及其他促成這項貢獻的因素？您預計 2025 年這一情況將如何發展？您也有高級表。而且，總體而言，Decipher 的滲透力很強，在市場上已經很成熟。

So, just trying to understand how should we think about Decipher 2025 and -- Decipher volume growth 2025 and longer term as well, given the status of this product with the strong clinical evidence behind it and metastatic also helping?

因此，只是想了解我們應該如何看待 Decipher 2025 以及——考慮到該產品的地位以及其背後強有力的臨床證據和轉移性幫助，Decipher 2025 年及更長期的銷量增長？

Yes. Thanks, Puneet. You talked about -- the key point here is the evidence because the NCCN is really just a -- kind of a manifestation of the great evidence that you have for a product and that we have for Decipher. I'll start by saying, obviously, I appreciate the incredible amount of work that goes into the NCCN process. It's a group of very hard-working individuals who spend time understanding the evidence, making sure they can assimilate that evidence and provide guidelines that are in the best interest of patients.

是的。謝謝，Puneet。您談到了——這裡的關鍵點是證據，因為 NCCN 實際上只是——您為某個產品以及我們為 Decipher 所擁有的大量證據的一種體現。首先我要說的是，我非常欣賞 NCCN 流程中所付出的大量工作。這是一群非常勤奮的人，他們花時間了解證據，確保他們能夠吸收這些證據並提供最符合患者利益的指導方針。

What's very clear is, NCCN has, I think, raised the bar and is very focused on Simon Level 1 evidence, whether it's Level 1A or Level 1B. We've determined that the table that's in the guidelines would be tests that have Level 1 evidence only. And I think it's probably fair to say, as an industry, we will strive to get to that level of robust evidence demonstration. And so Decipher is there, and I think that'd be doing a disservice to our team and our KOLs and our PIs and collaborators by not calling out that distinction and how important that is. Having said that, when it comes to -- for example, metastatic will be a good example of this.

非常清楚的是，我認為 NCCN 提高了標準，並且非常注重 Simon 1 級證據，無論是 1A 級還是 1B 級。我們已經確定指南中的表格將僅是具有 1 級證據的測試。我認為可以公平地說，作為一個行業，我們將努力達到強有力的證據證明水準。所以 Decipher 就在那裡，我認為如果不強調這種差異以及它的重要性，對我們的團隊、我們的 KOL、我們的 PI 和合作者來說是一種傷害。話雖如此，當談到——例如，轉移性就是一個很好的例子。

When it comes to launching a new pilot test that doesn't have NCCN guidelines, we need to continue to generate the evidence to get there. And so I do think the guidelines are very important. But as we demonstrated before, we all had guidelines, you can continue to grow and penetrate the market without. They certainly help to, I think, step it up. But really, at the end of the day, what they do is, they demonstrate that the test has incredibly robust evidence behind it.

當要啟動一項沒有 NCCN 指南的新試點測試時，我們需要繼續產生證據來實現這一目標。因此我確實認為這些指導方針非常重要。但正如我們之前所展示的，我們都有指導方針，你可以繼續發展並滲透市場。我認為，它們確實有助於提高這一水平。但實際上，最終他們所做的就是證明該測試背後有極為有力的證據。

With 85 publications, peer-reviewed publications for Decipher, I couldn't be more pleased with how much evidence we've gotten. We are continuing -- we're not standing still, we're continuing to generate evidence at a very nice clip. So I think that certainly helps to provide a tailwind, a continued tailwind for Decipher. I don't want to get specifically into guidance. You can obviously see the testing guide that we have.

Decipher 已發表了 85 篇經過同行評審的出版物，對於我們獲得的證據數量我感到非常滿意。我們正在繼續——我們不會停滯不前，我們正在以非常好的速度繼續產生證據。所以我認為這肯定有助於為 Decipher 提供順風，持續的順風。我不想具體地給出指導。您可以清楚地看到我們擁有的測試指南。

We've guided to Afirma, and so the Decipher volume is obviously a part of that equation as well.

我們已經引導了 Afirma，因此 Decipher 卷顯然也是該等式的一部分。

Yes. And the only other thing to help with that equation is, effectively Cyto is the plug, if you will, between Afirma and Decipher and the Cyto doesn't necessarily grow that materially. So I think you can assume Cytos roughly around the same level in '25 as it was in '24.

是的。而對這個等式有幫助的唯一其他東西是，實際上 Cyto 是 Afirma 和 Decipher 之間的插件，如果你願意的話，Cyto 不一定會在物質上增長那麼多。因此我認為你可以假設 Cytos 在 25 年的水平與 24 年的水平大致相同。

And then, just a clarification question. In terms of Prosigna, is that -- I just want to clarify, with the biopharma products and Prosigna, both of those will be obviously terminated with the French entity. Just can you clarify what products will continue forward? It appears Afirma and Decipher are the only 2 commercial products at this point, but I just want to make sure I have that right.

然後，只是一個澄清問題。就 Prosigna 而言，我只想澄清一下，生物製藥產品和 Prosigna 顯然都將與法國實體終止合作。您能否澄清一下哪些產品會持續發展？目前看來，Afirma 和 Decipher 是僅有的 2 款商業產品，但我只是想確保我擁有這個權利。

Yes. I'm glad you brought that up, Puneet, because I really do want to avoid confusion on this, and so want to be crystal clear. One is, there is no decision at this point to terminate or anything else. At this point, we're in consultation and we're considering no longer funding our French legal entity and that operation and that will impact, if that goes to either a sale or a bankruptcy process, it will impact our biopharma and other revenue clearly -- and that's coming out of that SAS entity. We do have a small amount of biopharma revenue that comes out of U.S.

是的。我很高興你提出這個問題，Puneet，因為我確實想避免在這個問題上造成混淆，所以我想說得非常清楚。一是，目前還沒有做出終止合約或其他任何決定。目前，我們正在協商，並考慮不再為我們的法國法人實體和業務提供資金，這將產生影響，如果進入出售或破產程序，這將明顯影響我們的生物製藥和其他收入——而這些收入都來自 SAS 實體。我們確實有少量的生物製藥收入來自美國。

entity, but that's neither here nor there at this point in terms of getting into and I don't want to confuse the situation. Turning to Prosigna, though, this is a really important point. No, we fully expect to continue Prosigna on the nCounter. And as we've mentioned before, at some point, we will move that test to NGS, and we do need to get our IVDR approval for that test on nCounter and ultimately on NGS. So, that's important.

實體，但就目前的情況而言，這既不是問題也不是問題，我不想混淆情況。然而，談到 Prosigna，這是一個非常重要的觀點。不，我們完全希望在 nCounter 上繼續 Prosigna。正如我們之前提到的，在某個時候，我們會將該測試轉移到 NGS，並且我們確實需要在 nCounter 和最終在 NGS 上獲得對該測試的 IVDR 批准。所以，這很重要。

Now that is being run out of our -- being manufactured by our Marseille operation. And so, being able to continue that supply of Prosigna is dependent, as I said in the prepared remarks, on being able to find a buyer for all or part of that business. So, we want to continue. We want to make sure our customers have access to that test, and that is top of mind for us right now. So no, this doesn't ultimately affect the long-term goal and the long-term IVD strategy.

現在，我們的馬賽工廠正在生產這些產品。因此，正如我在準備好的發言中所說，能否繼續供應 Prosigna 取決於能否找到該業務全部或部分產品的買家。所以，我們想繼續。我們希望確保我們的客戶能夠參加該測試，這是我們目前最關心的問題。所以，這最終不會影響長期目標和長期 IVD 策略。

We're committed to our IVD strategy. We're committed to getting our tests that make sense into other markets, including first off, Europe. And so this doesn't change that commitment. What it might change, as I mentioned in the prepared remarks, is our timelines for when we're able to get that certification and launch those tests. And so we're going to have to revisit our development road maps depending on how this process plays out.

我們致力於我們的 IVD 策略。我們致力於將我們的測試推廣到其他市場，首先是歐洲。所以這不會改變這項承諾。正如我在準備好的演講中提到的那樣，它可能會改變我們獲得認證和啟動測試的時間表。因此，我們將必須根據這一進程的進展重新審視我們的發展路線圖。

And then we'll have an update on those timelines when we've done that. Hopefully, Puneet, that clarifies that situation. If there's any remaining questions, please do let me know.

當我們完成後，我們將更新這些時間表。希望 Puneet 能夠澄清這一情況。如果還有其他問題，請告訴我。

Andrew Brackmann, William Blair.

安德魯布拉克曼、威廉布萊爾。

This is Maggie Boeye on for Andrew. Maybe the first one on guidance. Could you talk about what you view are potential upside levers for Decipher in 2025? What type of areas can we see to pull upside there?

我是 Maggie Boeye，代替 Andrew 發言。也許是第一個關於指導的。您能否談談您認為 2025 年 Decipher 的潛在上升潛力是什麼？我們可以看到哪些類型的區域有上漲空間？

Yes. I mean -- for me, I'd come from a couple of standpoints on Decipher. One is the significant amount of white space opportunity that is there in the market. As we've talked about, the test is only 40% penetrated coming into this year. We clearly have a lot of share there.

是的。我的意思是——對我來說，我會從幾個角度來看待 Decipher。一是市場上存在大量空白機會。正如我們所討論的，今年該測試的普及率僅為 40%。我們顯然在那裡佔有很大的份額。

But there -- the key point there is there's 60% that isn't penetrated and our goal is to drive molecular diagnostics in prostate cancer testing to 80%. And clearly, we'd like Decipher to be the leader there. So, that is priority #1, 2 and 3, and that's done through expanding the utilization within existing accounts. It's done by expanding into new accounts. It's also done by expanding into new indications like -- and as I've said earlier, metastatic being a factor kind of later in the year than earlier in the year.

但關鍵在於，還有 60% 尚未普及，我們的目標是將攝護腺癌檢測中的分子診斷普及率提高到 80%。顯然，我們希望 Decipher 成為該領域的領導者。所以，這是優先事項#1、2 和 3，這是透過擴大現有帳戶內的利用率來實現的。這是透過擴展到新帳戶來實現的。它也透過擴展到新的適應症來實現，例如——正如我之前所說，轉移性是一個在年底而不是年初出現的因素。

The incidence is also growing, sadly, which is an important point. And I think those are probably the key ones.

不幸的是，發病率也在上升，這是一個重要的觀點。我認為這些可能是關鍵因素。

The only other one I would add is, typically, at this point in time of the year, we don't have a ton of clarity on prior period collections. And so, to the extent we see a strong amount of those over the course of 2025, that could be upside as well.

我唯一想補充的是，通常，在每年的這個時候，我們對前期的收款情況並不太清楚。因此，如果我們在 2025 年看到大量此類現像出現，那麼這也可能是有利的。

Got it. And then maybe just one on NIGHTINGALE. As you continue to make progress on enrollment here with over 85% of the enrollment completed, can you just talk about your view on the market opportunity here? Has there been any changes to that as you continue to make progress there?

知道了。然後也許只在《夜鶯》上寫一篇。由於你們這裡的招生工作不斷取得進展，招生人數已超過 85%，您能談談對這裡的市場機會的看法嗎？隨著你們不斷取得進展，情況有沒有什麼改變？

Yes. The market -- thanks for asking. The market opportunity hasn't changed or at least our view of it hasn't. I mean it's still a leading major cause of cancers -- of death in cancer in terms of lung cancer, unfortunately. And it's a vast market, plenty of opportunity.

是的。市場——感謝您的詢問。市場機會沒有改變，或至少我們對它的看法沒有改變。我的意思是，不幸的是，它仍然是癌症（尤其是肺癌）死亡的主要原因。這是一個廣闊的市場，充滿機會。

The test utility -- sorry, validity has already been demonstrated with respect to how it can actually help patients and determine and classify patients into appropriate categories. NIGHTINGALE will hopefully demonstrate, and that's the key to it, that it also is able to change practice, right? And patients will be treated differently depending on whether they have a low, intermediate or high result based on our nasal swab test. But there is a tremendous amount of work to get done to get to that point, not only complete the enrollment, analyze the results, create a peer-reviewed publication from those results and get reimbursement in place. And as we've always said, we will make sure reimbursement is in place before we launch the test and then we're off to the races.

測試實用程式 - 抱歉，有效性已經得到證明，即它如何真正幫助患者並確定和將患者分為適當的類別。希望 NIGHTINGALE 能夠證明，這也是它的關鍵，它也能夠改變實踐，對嗎？並且，根據患者鼻拭子測試的結果是低、中或高，我們將對他們進行不同的治療。但要達到這一點還有很多工作要做，不僅要完成招生、分析結果、根據這些結果創建同行評審的出版物並獲得報銷。正如我們一直所說的那樣，我們將確保在啟動測試之前報銷到位，然後我們就可以開始比賽了。

So, no, nothing has really changed with respect to our view of the market and the market opportunity for nasal swabs. It all hinges on, as it always has, the clinical utility and us being able to demonstrate that through NIGHTINGALE, and it's too early to say whether that will be the case or not. Step number one is, continue the enrollment and follow up those patients and look at the data.

因此，就我們對市場的看法以及鼻拭子的市場機會而言，實際上沒有任何改變。一如既往，這一切都取決於臨床實用性，以及我們能否透過 NIGHTINGALE 證明這一點，現在判斷是否會出現這種情況還為時過早。第一步是繼續招募並追蹤這些患者並查看數據。

Lu Li, UBS.

盧莉，瑞銀。

A lot has been asked, so I will keep it short. I guess my first one on Decipher. If I'm doing the math right, it seems like the guidance assumed 25% growth. Can I just get a little bit more color on that? And how much is coming from pricing?

已經有很多問題了，所以我就長話短說吧。我想我是在 Decipher 上的第一個。如果我沒算錯的話，指導意見似乎假設成長 25%。我可以對此多加說明一下嗎？定價帶來的收益有多少？

I assume the majority is coming from volume? And second, on the MRD, it seems like you're already -- are you planning to submit the technical assessment to MolDx in the quarter? I wonder what is the kind of like the latest timeline we can expect from a reimbursement outcome? And then, do you think that all kind of (inaudible) around government agency will impact the timeline for the review?

我認為大部分是來自於音量？其次，關於 MRD，您似乎已經——您是否計劃在本季度向 MolDx 提交技術評估？我想知道我們能期待的報銷結果的最新時間表是什麼樣的？那麼，您是否認為政府機構周圍的所有類型（聽不清楚）都會影響審查的時間表？

Yes. So, on your first question, I think you know higher than the guideline -- the guidance would suggest for Decipher. Again, if you think about our guidance that we provided and you adjust for Envisia, it leads you to a testing revenue growth of 14% to 16% net of Envisia. And we said high single digits for Afirma. So if you do that math, you get Decipher somewhere in that low 20s, something like that.

是的。因此，關於您的第一個問題，我認為您了解的程度高於指南 - 指南會為 Decipher 提出建議。同樣，如果您考慮我們提供的指導並根據 Envisia 進行調整，那麼扣除 Envisia 後，測試收入將增加 14% 至 16%。我們預測 Afirma 的獲利將達到個位數。因此，如果你這樣計算的話，你會發現 Decipher 的價格在 20 多美元左右，諸如此類。

So, slightly lower than you cited. And that's the volume. And if we think about it right now, that's a volume factor more than anything else, given -- and Rebecca, feel free to jump in here if you've got anything to add. But given we had a lot of onetime collections last year, we had a big payer in the early part of last year that is now nicely embedded in the numbers. So, think of it that way for Decipher.

因此，比您提到的略低。這就是音量。如果我們現在考慮一下，那麼這首先是一個數量因素，因為——麗貝卡，如果你還有什麼要補充的，請隨時加入。但考慮到我們去年有很多一次性收款，我們在去年年初有一個大額付款人，現在已經很好地嵌入數字中。所以，請以這種方式來思考 Decipher。

On MRD reimbursement, tech assessment is this quarter. And then it's a case of completing everything we need to do in our lab, automation, et cetera, getting the test launched and then reimbursement should follow.

關於 MRD 報銷，技術評估是本季進行的。然後，我們需要完成實驗室中需要做的所有事情，包括自動化等等，然後啟動測試，最後獲得報銷。

And with regard to your question around federal agencies and will that have an impact? There's always a chance. I don't think any of us know really what the impact on the types of decisions that are going on will be. That being said, we are in active engagement with MolDx on this and other reimbursement questions and haven't seen any change in their posture or their engagement. So, we would hope that this would progress as planned, but obviously, there's always a tail risk to these sort of things given the dynamic of the situation.

關於您關於聯邦機構的問題，這會產生影響嗎？總是有機會的。我認為我們中沒有人真正知道這會對正在進行的決策產生什麼影響。話雖如此，我們正就此事和其他報銷問題與 MolDx 積極溝通，並沒有看到他們的態度或參與度有任何變化。因此，我們希望一切能夠按計劃進行，但顯然，考慮到情況的動態，這類事情總是存在尾部風險。

Sung Ji Nam, Scotiabank.

加拿大豐業銀行的 Sung Ji Nam。

This is Corey Rosenbaum on for Sung Ji. So you're continuing to strengthen your clinical evidence for Decipher Bladder, including the recent study published in European Urology Open Science. Do you see the prognostic and predictive use cases of Decipher Bladder as largely distinct from the MRD test under development? And if not, do you think there could be a significant opportunity to use both tests concurrently?

這是 Corey Rosenbaum 取代 Sung Ji 演繹的。因此，您正在繼續加強 Decipher Bladder 的臨床證據，包括最近在歐洲泌尿外科開放科學上發表的研究。您是否認為 Decipher Bladder 的預後和預測用例與正在開發的 MRD 測試有很大不同？如果沒有，您是否認為同時使用這兩項測試具有重大機會？

Yes. So to the first part of your question, we do see it as distinct. Obviously, the MRD test has now become our most important priority in bladder for muscle invasive bladder cancer. And that has a very distinct use case for patients who've been treated. In terms of the prognostic test itself, clearly, it's another opportunity to drive more into the channel.

是的。因此，對於您問題的第一部分，我們確實認為它是不同的。顯然，MRD 測試現在已經成為我們膀胱肌層浸潤性膀胱癌治療的最重要的優先事項。對於接受過治療的患者來說，這有非常獨特的用途。就預測測試本身而言，顯然這是另一個推動更多管道發展的機會。

It's more investment in the clinical utility, more studies like the ones that you mentioned, and that will be part of our road map over time, I'm sure, but it's not the immediate priority right now. But of course, yes, the more we can continue to serve the urologists and their offices, the more we will do that as long as we see that the cost of creating these studies is offset by the revenue opportunity in the future.

我相信，這需要在臨床實用性方面投入更多，需要進行更多像您提到的那樣的研究，隨著時間的推移，這將成為我們路線圖的一部分，但這不是目前的當務之急。但當然，是的，只要我們看到創建這些研究的成本被未來的收入機會所抵消，我們就越能繼續為泌尿科醫生和他們的辦公室提供服務，我們就會做得更多。

Got it. And again, on MRD, given the sensitivity advantages you expect from the C2i test, do you believe that the test will be viable potentially in the non-muscle invasive market as well for bladder cancer?

知道了。再次，關於 MRD，鑑於您期望 C2i 測試具有靈敏度優勢，您是否認為該測試在非肌肉侵入性膀胱癌市場中也具有可行性？

It is actually -- I mean, it's a platform, right? And you've talked about the sensitivity of it and the whole genome approach that we take for every sample, including not just the initial sample, but the serial testing samples, we think is unique, helps improve the performance of the test. In our minds, performance is measured by detection earlier than imaging. And so that we can -- believe that that test will have multiple applications in multiple cancers. Muscle invasive bladder cancer is current focus, whether it can be utilized in other bladder cancers and non-muscle invasive, maybe, but that wouldn't be -- in my mind, that wouldn't necessarily be the first place we would go.

它實際上——我的意思是，它是一個平台，對吧？您談到了它的敏感性以及我們對每個樣本採取的全基因組方法，不僅包括初始樣本，還包括連續測試樣本，我們認為這是獨一無二的，有助於提高測試的性能。在我們看來，性能是透過檢測而不是成像來衡量的。因此，我們相信該測試將在多種癌症中廣泛應用。肌肉浸潤性膀胱癌是目前的重點，它是否可以用於其他膀胱癌和非肌肉浸潤性膀胱癌，也許可以，但那不是——在我看來，那不一定是我們首先要去的地方。

I wouldn't see it as a larger market opportunity. I think there are larger opportunities where we currently have channel and serve customers or will have where we could launch that platform. But, we're not ready to actually give the detailed road map yet. But you can imagine anything is in play where there's a utility opportunity for MRD.

我不認為這是一個更大的市場機會。我認為，我們目前擁有的通路和服務客戶，或未來可以推出的平台，都擁有更大的機會。但是，我們還沒有準備好真正給出詳細的路線圖。但你可以想像，只要有 MRD 的實用機會，任何事情都可以發生。

Subbu Nambi, Guggenheim Securities.

Subbu Nambi，古根漢證券。

Coming into 2025, what is your commercial headcount? Meaning, what is the proportional mix of focus by product? And where do you -- where would you expect to build out more over the course of the year? That's question one. And question two, regarding the long -term outlook for Decipher, to the extent there is interest in using a digital pathology complement to your existing assays, how well are you positioned to bring something to market?

到 2025 年，您的商業員工人數是多少？意思是，重點產品的比例組合是怎麼樣的呢？您預計今年將在哪些方面取得更多進展？這是第一個問題。第二個問題，關於 Decipher 的長期前景，如果有人有興趣使用數位病理學來補充您現有的檢測方法，那麼您在將產品推向市場方面準備得如何？

Yes. So let me just quickly address the headcount question because one thing that's been really, I think, important for both our Decipher and Afirma franchise is, we've had tremendous leverage in our sales team. So we haven't added significant number of sales heads, single-digits over each year, and I don't see that changing going forward, given the current opportunities we have for both tests to broaden both market penetration and share. And I think it's roughly, as I said, 50 heads per Afirma; and Decipher, a little bit more. In terms of digital pathology, I think the important thing to think about there is, some of the studies that we've seen so far really don't demonstrate that digital pathology is any better than, and in some cases, actually not performing as well as the genomic test.

是的。因此，讓我快速回答一下員工人數的問題，因為我認為對於我們的 Decipher 和 Afirma 特許經營來說真正重要的一件事是，我們的銷售團隊擁有巨大的影響力。因此，我們並沒有增加大量的銷售人員，每年都只有個位數，而且考慮到我們目前透過這兩項測試來擴大市場滲透率和份額的機會，我認為這種情況未來不會改變。我認為，正如我所說，每個 Afirma 大約有 50 個頭；還有更多內容。就數位病理學而言，我認為需要考慮的重要一點是，我們迄今為止看到的一些研究並沒有真正證明數位病理學比基因組測試更好，在某些情況下，實際上表現不如基因組測試。

And I think the reason for that is they kind of focus on different biology, different parts of the biology. They're looking at different things, and consequently, there's not a great deal of correlation there. So if anything, we see maybe a complementary opportunity in the future. Whatever we do see the opportunity to be, and you can imagine, we watch it very, very closely, we couldn't be better positioned. And the reason I say that is we have hundreds of thousands of samples, tissue samples.

我認為原因是他們關注不同的生物學、生物學的不同部分。他們關注的是不同的事情，因此，兩者之間沒有太大的關聯。因此，如果有的話，我們可能會看到未來互補的機會。無論我們看到什麼機會，你可以想像，我們都會非常非常密切地關注它，我們處於最佳位置。我這樣說的原因是我們有數十萬個樣本，組織樣本。

We've already scanned in our lab over 50,000 samples across more than 30,000 patients. And the vast, vast majority of those have clinical outcomes. And so with that richness of our data, and remember, the richness comes from us being able to run a whole transcriptome in every case that gives us rich genomic data. Scanning is scanning. So we would have as rich digital pathology data as anybody else would have.

我們的實驗室已經掃描了超過 30,000 名患者的 50,000 多個樣本。其中絕大多數都有臨床結果。因此，我們的數據如此豐富，請記住，豐富性來自於我們能夠在每種情況下運行整個轉錄組，從而為我們提供豐富的基因組數據。掃描就是掃描。因此，我們將擁有與其他人一樣豐富的數位病理數據。

And then we have incredible AI capabilities already within our company. It's not like we have to go out and build or buy that. We already have that. And so, with that richness of data, we could do whatever analysis we need to do and publish on that. Again, it would be a question of the priorities.

我們公司已經擁有令人難以置信的人工智慧能力。這並不是說我們必須出去建造或購買它。我們已經擁有了。因此，有瞭如此豐富的數據，我們可以進行任何需要的分析並發布結果。這又是一個優先順序的問題。

We have lots of things to do right now which we think have a better near-term priority and opportunity for the company. But bear in mind, we always have this in our back pocket to the extent we need it. And we'll continue to do research and fund research or support research that looks at the opportunities for digital pathology and AI in our markets, not just in prostate, and we'll always stay ahead of the curve.

我們現在有很多事情要做，我們認為這些事情對公司來說有更好的近期優先事項和機會。但請記住，只要我們需要，我們總是會把它放在我們的後車箱裡。我們將繼續進行研究、資助研究或支持研究，探索數位病理學和人工智慧在我們的市場（不僅僅是前列腺領域）的機會，我們將始終保持領先地位。

Tejas Savant, Morgan Stanley.

摩根士丹利的 Tejas Savant。

This is Yuko on the call for Tejas. Some of the current players in the MRD market are now pursuing both tumor-informed and tumor-naive approaches. What are your thoughts on that direction of travel in MRD? And could we see you pursue both options down the road? And then more importantly, do you think that physician preference will evolve where each approach is preferred in certain cancer types versus one-size-fits-all approach?

我是 Yuko，正在為 Tejas 打電話。目前 MRD 市場中的一些參與者正在同時追求腫瘤知情方法和腫瘤幼稚方法。您對 MRD 的發展方向有何看法？我們是否可以看到您將來同時追求這兩個選項？更重要的是，您是否認為醫生的偏好會改變，即針對特定類型的癌症採用不同的治療方法，而不是一刀切的方法？

Yes, it's a great question. Of course, we think about that a lot. And I think in a nutshell, I do believe that our MRD approach with whole genome in particular, lends itself very well to all the research and studies we would need to do to demonstrate validity in tumor naive. But I think at this point and where we are in the market, our view is tumor-informed, where you have tissue, obviously, is by far the better performing test. Tumor-naive comes into its own where you don't have tissue, hard to get to tissue et cetera.

是的，這是一個很好的問題。當然，我們對此考慮了很多。簡而言之，我確實相信我們的 MRD 方法，特別是全基因組方法，非常適合我們需要做的所有研究，以證明其在腫瘤初治中的有效性。但我認為，就目前的情況以及我們在市場上的立場而言，我們的觀點是基於腫瘤的，顯然，對有組織的腫瘤進行檢測是迄今為止效果更好的測試。腫瘤幼稚是指沒有組織、難以取得組織等狀況。

But right now, for the vast majority of the market, you do have tissue, you have enough of it. You don't need a lot to do that initial sequence. And with a whole genome approach, it is by far the best approach. But as I said, it does lend itself to the studies we need to do to support human naive in the future. And I do think that both will be offered.

但目前，對於絕大多數市場來說，你確實有紙巾，而且有足夠的紙巾。您不需要做很多事情來完成初始序列。採用全基因組方法，這是迄今為止最好的方法。但正如我所說，它確實有助於我們未來支持人類天真所需的研究。我確實認為兩者都會提供。

Whether a physician preference or not, I think it's a little early for me to say, and I don't have the data to suggest one way or the other on that. Certainly, we could get that. But I think it's going to come down to a number of factors. I think what's most important is a company like us that has the platform to be able to support whatever paradigms make most sense for the patient and the physician in the future. And it's hard for me to imagine a world where we're not all thinking about whole genome approaches 5 to 10 years from now.

無論這是否是醫生的偏好，我認為現在下結論還為時過早，而且我也沒有數據來表明這一點。當然，我們可以得到它。但我認為這取決於多種因素。我認為最重要的是像我們這樣的公司擁有平台，能夠支持未來對患者和醫生最有意義的任何範例。我很難想像 5 到 10 年後我們不再考慮全基因組方法的世界。

I think whole genome is absolutely the way to go because it does support those kinds of studies and product enhancements and expansions.

我認為全基因組絕對是可行的方法，因為它確實支持此類研究以及產品的增強和擴展。

Great. That was helpful color. And then my follow-up question, given the unique approach that you're taking in MRD with C2i, do you think that you have an opportunity to file for ADLT status? Is that something you may pursue?

偉大的。那是有用的顏色。然後我的後續問題是，鑑於您在 C2i 的 MRD 中採取的獨特方法，您認為您有機會申請 ADLT 身分嗎？這是你可以追求的嗎？

Obviously, for muscle invasive bladder cancer, the answer is no, we don't need to, right? So we are where we are right now, and there's an LCD, and we're going to be able to just get to the market as soon as we can with that approach. ADLT is a unique situations, and if there are unique situations where ADLT makes sense, then it's as open to us as it is to anybody else. But, not -- so I don't think I would -- I don't build a strategy around ADLT or not ADLT, our strategy is built around can we get a test reimbursed at an appropriate level given the number of sequences you have to do. And there are some things that as an industry, I think we need to evolve in terms of how MRD gets priced.

顯然，對於肌肉層浸潤性膀胱癌，答案是否定的，我們不需要，對嗎？所以我們現在處於這樣的狀態，並且有一個 LCD，我們將能夠透過這種方式盡快進入市場。ADLT 是一種獨特的情況，如果存在 ADLT 有意義的獨特情況，那麼它對我們和其他人一樣開放。但是，不是——所以我不認為我會——我不會圍繞 ADLT 或非 ADLT 制定策略，我們的策略是圍繞我們能否根據您必須進行的序列數量獲得適當水平的測試報銷而製定的。我認為，作為一個行業，我們需要在 MRD 定價方式上做出一些改進。

MRD is a paradigm that hasn't been contemplated when a lot of these coverage determinations were put in place. And so there's some evolution that needs to happen there. But with that said, I think we'll build our strategy around getting the test launched with the appropriate pricing, managing our COGS to a level where we feel that the test is able to perform with an appropriate level of gross margin.

在製定許多此類覆蓋範圍決定時，MRD 是一個尚未被考慮到的範例。因此那裡需要發生一些演變。但話雖如此，我認為我們將圍繞以適當的價格推出測試來製定我們的策略，將我們的 COGS 管理到我們認為測試能夠以適當的毛利率水平執行的水平。

Mike Matson, Needham & Company.

麥克‧馬森 (Mike Matson)，Needham & Company。

This is Joseph on for Mike. I guess, on Decipher, lot of levers of growth there, indication expansion, obviously in the market in general. But maybe just to focus on share gains in the market from your competitors. Can you maybe just talk about, like big picture, what that looks like for you guys? Is it more individually with your sales force going in and converting people directly?

約瑟夫代替麥克發言。我想，在 Decipher 上，有許多成長槓桿，顯示擴張，顯然在整個市場中都是如此。但也許只是專注於從競爭對手手中奪取市場份額。您能否簡單談談整體情況，這對你們來說是什麼樣子的？您的銷售人員是否能夠更個人化地直接與客戶進行銷售？

Or do you think a lot of it is more passively driven from clinicians seeing stuff, like the NCCN recommendation and just the division between your competitors in terms of clinical evidence? And then if I could just ask the follow-up. Afirma GRID, I was just kind of curious if you could give any metrics there, maybe compare it to Decipher GRID? I guess the same proportion kind of opting for that. I believe you said it was somewhere around one in every two physicians for Decipher GRID?

或者您認為其中許多都是由臨床醫生被動地看到的東西引起的，例如 NCCN 建議以及競爭對手在臨床證據方面的分歧？然後我是否可以問一下後續問題。Afirma GRID，我只是有點好奇您是否可以提供任何指標，也許可以將其與 Decipher GRID 進行比較？我想選擇這種方式的人比例是相同的。我相信您說過，大約每兩名醫生中就有一名是 Decipher GRID 的醫生？

Yes, happy to. In fact, maybe I'll just go to the GRID one first. I don't remember the exact metric on Afirma. You're right, it was one in two for Decipher and so was...

是的，很高興。事實上，也許我會先去 GRID。我不記得 Afirma 的具體指標。你說得對，對於 Decipher 來說，它是二分之一，所以...

It was roughly around the same.

大致相同。

Roughly around the same. Maybe 30% to 50% would be a reasonable estimate for that. The uptake has been pretty decent so far. In terms of Decipher and share, you can't really separate sales team going out and blocking and tackling from the -- what you described as the passive reaction or response from KOLs because there's kind of -- the sales team will highlight to the physician, the extent of evidence that exists and what it means and why it's important, including the NCCN guidelines. So if we take a step back, all of this comes from robust evidence.

大體上是差不多的。也許 30% 到 50% 是一個合理的估計。到目前為止，吸收率已經相當不錯。就解讀和分享而言，你不能真正將銷售團隊的外出、阻止和處理與你所描述的來自 KOL 的被動反應或回應分開，因為銷售團隊會向醫生強調現有證據的範圍、其含義和重要性，包括 NCCN 指南。所以如果我們退一步來看，這一切都來自於確鑿的證據。

It starts with robust evidence, which in our view, starts with our whole transcriptome approach. That drives a lot of studies, both studies that we fund or support to studies that we aren't even remotely involved in that just get done with Decipher given how much real-world data there exists for the test. And so, we see a lot of studies being completed. Our sales reps bring those to the physicians' attention. Some obviously pay more attention to those studies than others, saying, obviously, those studies result in NCCN guidelines.

它始於強有力的證據，在我們看來，始於我們的整個轉錄組方法。這推動了大量的研究，包括我們資助或支持的研究，以及我們根本沒有參與的研究，這些研究只是利用 Decipher 完成的，因為測試中存在大量的真實數據。因此，我們看到很多研究已經完成。我們的銷售代表會將這些問題提請醫生注意。有些人顯然比其他人更關注這些研究，他們說，顯然這些研究會制定 NCCN 指南。

They result in things like Level 1 evidence, which then result in guidelines. And that -- again, that's an important factor to sway some physicians, not all, but some. And I think when you put it all together, it's the blended effect of all of these things that has really driven Decipher's success in both RP and biopsy. And I couldn't be more excited with the growth we've seen across all NCCN categories. And I think that just demonstrates how Decipher is really covering the whole care continuum.

它們會產生諸如 1 級證據之類的東西，然後產生指導方針。再說一次，這是影響一些醫生（不是全部，但對一些醫生來說）的一個重要因素。我認為，當你把所有這些因素綜合起來時，所有這些因素的混合效應才真正推動了 Decipher 在 RP 和活檢方面的成功。我對我們所看到的 NCCN 所有類別的成長感到非常興奮。我認為這正好證明了 Decipher 確實覆蓋了整個護理過程。

And once we add metastatic, I mean and I truly will be able to see the whole care continuum. for Decipher or the whole risk stratification for Decipher patients. So, no, hard to say it's all of that. It's just -- it's giving our sales reps incredible information to share with physicians and have a good reason to go out and do that.

一旦我們添加了轉移性，我的意思是，我將真正能夠看到整個護理過程。用於 Decipher 或 Decipher 患者的整體風險分層。所以，不，很難說這就是全部。這只是——它為我們的銷售代表提供了令人難以置信的信息，可以與醫生分享，並且有充分的理由出去這樣做。

Matt Sykes, Goldman Sachs.

高盛的馬特·賽克斯 (Matt Sykes)。

This is Prashant Kota on for Matt. I have one question that's a two-parter. So building off of Puneet's question earlier, is it possible to quantify the benefit of NCCN guideline inclusion for a given test in terms of adoption, insurance reimbursement and competitive positioning? And then my second part is, as you enter new indications, given your NCCN guideline inclusion for Decipher Prostate, does this increase the likelihood that future tests you may develop will get included in guidelines?

我是 Prashant Kota，代替 Matt 發言。我有一個問題，分成兩個部分。那麼，根據 Puneet 先前提出的問題，是否有可能從採用、保險報銷和競爭定位的角度量化 NCCN 指南對特定測試的納入帶來的好處？然後我的第二部分是，當您輸入新的適應症時，考慮到您的 NCCN 指南納入了 Decipher Prostate，這是否會增加您將來開發的測試被納入指南的可能性？

Yes. I appreciate the questions. It's not possible to quantify the benefit of NCCN because they're just part of a whole package of positive indicators that really support the use of a test for a patient. Obviously, it's helpful. It's incredibly valuable, but you can't literally take it apart and figure out which Decipher test would have been utilized with or without NCCN guidelines.

是的。我很感謝你們提出這些問題。無法量化 NCCN 的益處，因為它們只是真正支持對患者進行測試的整套正面指標的一部分。顯然，這是有幫助的。它非常有價值，但你無法真正地把它拆開，然後弄清楚在有或沒有 NCCN 指南的情況下會使用哪種 Decipher 測試。

And I don't think it actually helps us -- you're kind of at the starting point or a level playing field when it comes to new indications and different indications as well for different cancer types. So a good example of that is metastatic. I mean the NCCN guidelines for metastatic is going to be based on the peer-reviewed publications, what level of evidence, when you get to Simon Level 1 evidence, which is the new threshold and. And we're going to have to get there over time. Same with a new indication in a new cancer type.

我認為這實際上對我們沒有幫助——當涉及新的適應症以及針對不同癌症類型的不同適應症時，你處於一個起點或公平的競爭環境。轉移性就是一個很好的例子。我的意思是，NCCN 轉移性指南將基於同行評審的出版物，當你獲得 Simon 1 級證據時，什麼程度的證據，這是新的門檻。我們必須隨著時間的推移才能實現這一目標。與新癌症類型的新適應症相同。

So, no, it's -- I don't think it helps you there at all. I do think that knowing what it takes to and having the engine in the company to support and create that level of evidence, have those strong, robust studies with scientific rigor behind them, get them through peer-reviewed publications, those are all factors that help you get this kind of recognition that we're getting from [NCCN]. And so there is a competitive advantage to having done it before, but that's how I would characterize it.

所以，不，我認為它對你沒有任何幫助。我確實認為，了解需要什麼，擁有公司內部的引擎來支持和創造這種程度的證據，擁有那些強有力的、科學嚴謹的研究，並通過同行評審的出版物，這些都是幫助你獲得這種認可的因素，就像我們所得到的一樣[NCCN]。因此，以前做過這件事就有競爭優勢，但這就是我對其的描述。

Thank you. This concludes our question-and-answer session and today's conference call. Thank you for participating. You may now disconnect.

謝謝。我們的問答環節和今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。