Natera Inc (NTRA) 2025 Q3 法說會逐字稿

Welcome to Netera's 2025 third-quarter financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, November 6, 2025.

歡迎參加Netera 2025年第三季財務業績電話會議。（操作員說明）提醒各位，本次電話會議將於2025年11月6日進行錄音。

I would now like to turn the conference call over to Michael Brophy, Chief Financial Officer.

現在我將把電話會議交給財務長邁克爾·布羅菲。

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our third quarter of 2025. On the line, I'm joined by Steve Chapman, our CEO; Solomon Moshkevich, President of Clinical Diagnostics; and Alex Aleshin, General Manager of Oncology and our Chief Medical Officer. Today's conference call is being broadcast live via webcast. We will be referring to a slide presentation that has been posted to investor.natera.com. A replay of the call will also be posted to our IR site as soon as it's available.

謝謝接線生。午安.感謝您參加我們的電話會議，討論我們 2025 年第三季的業績。連線嘉賓有：我們的執行長史蒂夫·查普曼；臨床診斷總裁所羅門·莫什克維奇；以及腫瘤科總經理兼首席醫療官亞歷克斯·阿列申。今天的電話會議將透過網路直播。我們將參考已發佈在 investor.natera.com 上的幻燈片簡報。電話會議的錄音也將在可用時立即發佈在我們的投資者關係網站上。

Starting on Slide 2. During the course of this conference call, we will make forward-looking statements regarding future events and our anticipated future performance, such as our operational and financial outlook and projections, our assumptions for the outlook, market size, partnerships, clinical studies and expected results, opportunities and strategies and expectations for various current and future products, including product capabilities, expected release dates, reimbursement coverage and related effects on our financial and operating results.

從第二張投影片開始。在本次電話會議期間，我們將就未來事件和我們預期的未來業績發表前瞻性聲明，例如我們的營運和財務展望及預測、我們對展望的假設、市場規模、合作夥伴關係、臨床研究和預期結果、機會和策略以及對各種當前和未來產品的預期，包括產品功能、預期發布日期、報銷範圍以及對我們的財務和營運績效的相關影響。

We caution you that such statements reflect our best judgment based on factors currently known to us and that actual events or results could differ materially. Please refer to the documents we file from time to time with the SEC, including our most recent Form 10-K or 10-Q and the Form 8-K filed with today's press release.

我們提醒您，此類聲明反映了我們基於目前已知因素的最佳判斷，實際事件或結果可能與此有重大差異。請參閱我們不時向美國證券交易委員會提交的文件，包括我們最新的 10-K 表格或 10-Q 表格以及今天隨新聞稿一起提交的 8-K 表格。

Those documents identify important risks and other factors that may cause our actual results to differ materially from those are contained in or suggested by the forward-looking statements. Forward-looking statements made during the call are being made as of today, November 6, 2025. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information.

這些文件列出了可能導致我們的實際結果與前瞻性聲明中包含或暗示的結果有重大差異的重要風險和其他因素。本次電話會議中所作的前瞻性陳述截至今日（2025 年 11 月 6 日）為止。如果今天之後重播或回顧此通話，通話期間提供的資訊可能不再是最新或準確的資訊。

Natera disclaims any obligation to update or revise any forward-looking statements. We will provide guidance on today's call but will not provide any further guidance or updates on our performance during the quarter unless we do so in a public forum. We will quote a number of numeric or growth changes as we discuss our financial performance. And unless otherwise noted, each such reference represents a year-on-year comparison.

Natera公司聲明不承擔更新或修改任何前瞻性聲明的義務。我們將在今天的電話會議上提供業績指引，但除非在公開場合，否則不會提供任何關於本季業績的進一步指引或更新。在討論財務表現時，我們將引用一些數字或成長變化。除非另有說明，否則每個此類參考數據均代表同比比較。

And now I'd like to turn the call over to Steve. Steve?

現在我想把電話交給史蒂夫。史蒂夫？

Thanks, Mike. Let's get to the highlights on the next slide. We had a fantastic quarter. We generated $592 million in revenue, which is up about 35% over Q3 of last year. We had an excellent volume quarter as well, which included strong growth across the product portfolio and another record for Signatera growth.

謝謝你，麥克。讓我們來看下一頁的重點內容。我們這個季度業績非常出色。我們創造了 5.92 億美元的收入，比去年第三季成長了約 35%。我們的銷售季度也表現出色，產品組合整體強勁成長，Signatera 的成長也再次創下紀錄。

We processed 202,000 clinical MRD tests in the quarter, which represents more than 21,500 units of growth compared to the second quarter. You'll recall that we had a record of 20,000 Signatera growth units in Q2, so we're very pleased to beat that record again in Q3. Gross margin took a big step up in Q3, coming in at 64.9%, which is almost 1.5 percentage points higher than we were just last quarter. Ex true-ups, gross margins grew over a full percentage point versus Q2 and almost 3 percentage points over Q3 of last year.

本季度我們處理了 202,000 例臨床 MRD 檢測，與第二季度相比增長了 21,500 多例。您可能還記得，我們​​在第二季度創下了 Signatera 增長單元 20,000 個的記錄，因此我們非常高興在第三季度再次打破這一記錄。第三季毛利率大幅提升至 64.9%，較上一季高出近 1.5 個百分點。剔除調整因素後，毛利率較第二季成長超過一個百分點，較去年第三季成長近3個百分點。

Given all that momentum, we are in a position to significantly increase the 2025 financial guide. We are raising the revenue guidance by $160 million at the midpoint and now expect revenues in the range of $2.18 billion to $2.26 billion, which is a full reset of the prior revenue range. We are raising the gross margin guide to 62% to 64% in recognition of the gross margin performance we saw in the first 3 quarters and ASP and COGS momentum continuing in the business.

鑑於目前的良好勢頭，我們有能力大幅提高 2025 年的財務預期。我們將營收預期中位數上調 1.6 億美元，目前預計營收將在 21.8 億美元至 22.6 億美元之間，這與先前營收預期完全相反。鑑於前三個季度毛利率表現良好，且平均售價和銷售成本持續成長，我們將毛利率預期上調至 62% 至 64%。

We are also modestly bumping OpEx guidance, which is largely from the onetime expenses that have accumulated over the course of the year that now total around $60 million. In addition to those onetime expenses, there's a small increase in R&D to support MolDx coverage for the remaining Signatera indications. Based on this effort, I'm excited to announce we are now in a position to submit 7 new MolDx submissions before the end of the year this year, which we said can be worth around $250 million to $300 million of gross profit based on our run rate.

我們也略微上調了營運支出預期，這主要是由於今年累計的一次性支出，目前總額約為 6,000 萬美元。除了這些一次性支出外，研發投入也有小幅增加，以支持 MolDx 對 Signatera 剩餘適應症的覆蓋範圍。基於這項努力，我很高興地宣布，我們現在有能力在今年年底前提交 7 項新的 MolDx 申請，根據我們的運行速度，這些申請可以帶來約 2.5 億美元至 3 億美元的毛利。

We've also invested to expand the market by increasing the number of definitive MRD trials and to support the FDA-enabling FIND study for early cancer detection. It's important to note that our SG&A was flat to down between Q2 and Q3, which is aligned with what we said about pre-spending to build the commercial team in the first half of the year. We aren't planning any big commercial expansions anytime soon, and we'll talk a little bit more about that later in the call.

我們也投資擴大市場，增加確定性 MRD 試驗的數量，並支持 FDA 批准的 FIND 研究，以進行早期癌症檢測。值得注意的是，我們的銷售、一般及行政費用在第二季度和第三季度之間持平或下降，這與我們之前所說的在上半年預先支出以組建商業團隊的說法相符。我們近期沒有大規模商業擴張的計劃，稍後我們會在電話會議中詳細討論這個問題。

Finally, on guidance, we are substantially raising our guide for free cash flow generation for the year, where we are now formally expecting to generate roughly $100 million in cash for the full year. Of course, we were thrilled to see the Signatera data readout from the IMvigor011 trial in bladder cancer, and we appreciate Dr. Tom Powles for joining us on the special call we held a few weeks ago to review the results.

最後，關於業績指引，我們大幅提高了全年自由現金流預期，目前我們正式預計全年將產生約 1 億美元的現金。當然，我們很高興看到 Signatera 公司公佈了膀胱癌 IMvigor011 試驗的數據，並感謝 Tom Powles 博士幾週前參加了我們召開的特別電話會議，共同回顧了試驗結果。

We think the IMvigor trial results represent a fundamental new paradigm in cancer care enabled by Signatera, and that data has been published now in the New England Journal of Medicine. Finally, we touched on our last call that we were very excited to launch Fetal Focus, a new single-gene NIPT for inherited conditions that leverages our proprietary SNP-based method. We recently announced an expansion of the Fetal Focus product to cover over 20 genes planned for this quarter. The initial feedback from our August launch is positive, and we think this is a compelling expansion of the panel.

我們認為 IMvigor 試驗結果代表了 Signatera 實現的癌症治療領域的一個根本性新範式，相關數據現已發表在《新英格蘭醫學雜誌》上。最後，我們提到了上次電話會議中提到的，我們非常興奮地推出了 Fetal Focus，這是一種利用我們專有的基於 SNP 的方法檢測遺傳疾病的新型單基因 NIPT。我們最近宣布，將擴大 Fetal Focus 產品範圍，計劃在本季涵蓋 20 多個基因。8 月的發表會獲得了正面的回饋，我們認為這是小組的一次有力擴充。

Okay. Let's get into some of the business trends on the next slide. The first slide shows our Q3 volume progression versus prior years. We had solid sequential quarterly growth in women's health, driven in part by interest in Fetal Focus that spurred a lot of new commercial activity for our team.

好的。接下來，我們將在下一張投影片中探討一些商業趨勢。第一張投影片展示了我們第三季銷售量與往年同期相比的變化。我們在女性健康領域實現了穩健的季度環比增長，部分原因是受 Fetal Focus 的關注，這激發了我們團隊開展許多新的商業活動。

Organ health was also very strong with both greenfield and competitive wins, and we will continue to keep our foot on the gas as we have several clinical trials ongoing that further demonstrate how much utility and cost savings these tests are delivering. Of course, Signatera posted another record quarter, which we'll get into on the next slide. Overall, the volume momentum in Q3 was very strong across the products and that has continued into Q4 thus far.

器官健康領域也表現非常強勁，我們在新領域和競爭性領域都取得了成功，我們將繼續加大投入，因為我們正在進行多項臨床試驗，這些試驗將進一步證明這些檢測能夠帶來多大的實用性和成本節約。當然，Signatera 又創下了季度業績新高，我們將在下一張投影片中詳細介紹。整體而言，第三季各產品的銷售成長動能非常強勁，而且這股動能一直延續到第四季。

The next slide shows our clinical MRD unit growth over time. We had another record growth of 21,500 additional units, which includes more than 21,000 Signatera growth units and a few hundred Latitude growth units. As a reminder, we offer Latitude as a reflex to Signatera when Signatera can't be performed. This unit growth represents 56% year-on-year growth versus Q3 of last year, and this is the fastest year-on-year growth rate we've had in all of 2025.

下一張投影片展示了我們臨床 MRD 部門隨時間推移的成長。我們又創下了成長紀錄，新增單元數量達到 21,500 套，其中包括超過 21,000 套 Signatera 成長單元和數百套 Latitude 成長單元。提醒一下，當 Signatera 無法執行時，我們會提供 Latitude 作為 Signatera 的替代方案。這一單位成長較去年第三季成長了 56%，也是 2025 年至今最快的年成長率。

The drivers here are really the same as we covered on prior calls, groundbreaking clinical data combined with excellent customer experience. New patient starts were again strong as physicians continue to use the test for ongoing monitoring. We see adoption being fueled by the excellent data released earlier this year, including at ASCO, ASCO GI and ESMO. We haven't had time yet to see the effect of the recent ESMO data for the publication in the New England Journal of Medicine, but clearly, those are both very positive factors.

這裡的驅動因素其實和我們之前電話會議中討論的一樣，那就是突破性的臨床數據與卓越的客戶體驗相結合。由於醫生們繼續使用該檢測方法進行持續監測，新患者的新增病例數再次強勁成長。我們看到，今年稍早發布的優秀數據（包括在 ASCO、ASCO GI 和 ESMO 上發布的數據）正在推動這一趨勢的普及。我們還沒有時間看到最近 ESMO 數據對《新英格蘭醫學雜誌》發表的影響，但顯然，這些都是非常積極的因素。

We'll talk more about the implication of these results later in the call. The mix of tumor types we are seeing continues to be broad-based as physicians really start to generalize the use of Signatera in their clinics. That broad adoption drives volume growth but also creates a large revenue opportunity as we broaden the range of tumor types that we can get reimbursed.

我們將在稍後的電話會議中詳細討論這些結果的影響。隨著醫生開始在診所中廣泛使用 Signatera，我們看到的腫瘤類型組合仍然很廣泛。這種廣泛的應用不僅推動了銷售成長，也創造了巨大的收入機會，因為我們擴大了可以獲得報銷的腫瘤類型範圍。

The next slide shows revenue, which was another area of significant outperformance this quarter. We grew revenues 35% over last year, which is actually faster than Q2 despite the tough comparable. This was from strong volume performance combined with excellent progress on ASPs. Each of our major products had a sequential improvement in ASP in Q3 compared to Q2.

下一張投影片顯示的是營收，這是本季另一個表現顯著優於平均的領域。我們營收年增 35%，儘管去年同期基數較高，但實際成長率仍高於第二季。這得益於強勁的銷售表現以及平均售價的顯著提升。與第二季相比，我們所有主要產品的平均售價在第三季均有所提高。

Women's health and organ health each had another standout quarter and Signatera ASPs are now at roughly $1,200. We had about $55 million in true-ups this quarter as cash collections continue to accelerate, and we posted another record for DSOs at 49 days compared to 57 days just in Q2. That trend has continued in Q4 as October was a clear new record for cash collections. All of this bodes well for future ASP growth, as Mike will describe later in the call.

女性健康和器官健康領域都再次取得了突出的季度業績，Signatera 的平均售價目前約為 1200 美元。本季我們進行了約 5,500 萬美元的調整，現金回收持續加速，同時我們的應收帳款週轉天數 (DSO) 也創下新紀錄，達到 49 天，而第二季為 57 天。這一趨勢在第四季得以延續，10 月現金回收額創下新紀錄。所有這些都預示著未來平均售價將大幅成長，麥克稍後將在電話會議中對此進行詳細描述。

The next slide shows our gross margin traction over time, and we posted another strong gross margin quarter in Q3. Top line gross margins were a record as we got very close to that 65% level. Stripping out the revenue true-ups, we grew gross margins a full percentage point to 61.3% just compared to Q2. We drove that with a combination of better ASPs as well as COGS, which were also very lean in the quarter across the board.

下一張投影片展示了我們毛利率隨時間推移的成長情況，我們在第三季又取得了強勁的毛利率。毛利率創下歷史新高，我們非常接近 65% 的水平。剔除營收調整因素後，僅與第二季相比，我們的毛利率就成長了一個百分點，達到 61.3%。我們透過提高平均售價和降低銷售成本來實現這一目標，而且本季所有產品的銷售成本都非常低。

In addition to COGS efficiencies, we spent some time on our last call talking about the other key margin expansion vectors we're pursuing. Investing in revenue cycle operations has been a huge win for us over the last 2 years, and we are now at a level where we think we can hold that dollar spending steady as we continue to grow ASPs, which gives us leverage on the prior investments.

除了提高銷售成本效率外，我們在上次電話會議上還花了一些時間討論我們正在追求的其他關鍵利潤率擴張途徑。過去兩年，投資收入周期營運對我們來說是一次巨大的成功，現在我們認為，隨著平均售價 (ASP) 的持續成長，我們可以保持這筆資金支出的穩定，這使我們能夠利用先前的投資。

I also mentioned the coverage expansion opportunity that was really across the board, but particularly in Signatera. In addition to getting more tumor types covered by Medicare, we are starting to see some green shoots in biomarker state reimbursement for commercial volumes. We estimate the growth in Signatera ASP this quarter was driven primarily by the success we had in the spring and fall working with health plans in these states to cover Signatera for their patients.

我還提到了覆蓋範圍擴大的機會，這實際上是全方位的，尤其是在 Signatera 方面。除了讓更多類型的腫瘤納入醫療保險覆蓋範圍外，我們還開始看到生物標記在商業交易量方面獲得州級報銷的一些積極跡象。我們估計本季 Signatera ASP 的成長主要得益於我們在春季和秋季與這些州的健康計劃合作，為他們的患者提供 Signatera 服務方面取得的成功。

I think it's going to be a pretty steady linear process for us over the next two years or so. Finally, all of the above can be accelerated with the deployment of AI. In addition to driving innovation, for example, with our foundation models, AI is already helping us scale these operations as volumes grow without forcing a commensurate increase in headcount.

我認為在接下來的兩年左右時間裡，對我們來說將是一個相當穩定的線性過程。最後，以上所有方面都可以透過部署人工智慧來加速實現。除了推動創新之外，例如透過我們的基礎模型，人工智慧已經幫助我們隨著業務量的成長而擴展這些營運規模，而無需相應地增加員工人數。

Okay. That's a good segue to the next slide on OpEx. We went into some detail on the last call describing the investments we are making this year in both R&D and commercial operations to extend our leadership in MRD. Looking at Q3, this R&D increase reflects the investments we made to support multiple new product launches as well as the expansion of our clinical trial and data generation efforts for both Signatera and early cancer detection.

好的。這正好可以引出下一張關於營運支出的幻燈片。在上次電話會議上，我們詳細介紹了今年在研發和商業營運方面的投資，以鞏固我們在MRD領域的領先地位。從第三季來看，研發投入的增加反映了我們為支持多個新產品上市而進行的投資，以及我們在 Signatera 和早期癌症檢測方面的臨床試驗和數據生成工作的擴展。

This year, we've launched Signatera Genome, Latitude tissue-free MRD, Fetal Focus single-gene NIPT, and we're about to launch this expanded version of Fetal Focus. All of these things put us in a position to keep doing well in the market and to continue helping millions of patients per year.

今年，我們推出了 Signatera Genome、Latitude 無組織 MRD、Fetal Focus 單基因 NIPT，並且即將推出 Fetal Focus 的擴展版本。所有這些因素都使我們能夠在市場上繼續保持良好表現，並繼續每年幫助數百萬名患者。

In clinical trials, as I mentioned, we're doubling down on evidence generation and that investment we've been making has really paid off. We are now in a position to submit seven new MolDx submissions by the end of the year. And as I mentioned earlier in the call, reimbursement for all the remaining indications could be worth around $250 million to $300 million of gross profit based on our run rate. So this is well worth the investment.

正如我之前提到的，在臨床試驗中，我們正在加倍投入證據的收集，而我們所做的投資確實取得了回報。我們現在有能力在年底前提交七份新的 MolDx 申請。正如我之前在電話會議中提到的，根據我們的營運速度，所有剩餘適應症的報銷可能價值約 2.5 億美元至 3 億美元的毛利。所以這筆投資非常值得。

In addition, we are launching many interventional trials to continue advancing the field towards incorporating personalized MRD into the standard of care. In addition to Signatera, the advanced adenoma data we now have in hand gives us a lot of confidence to push as fast as we can to get a high-quality result in the FDA-enabling FIND trial, which is already enrolling. This is a big investment, but we think it's worth it given the very attractive opportunity in ECD that includes a large market size, high gross margins and a very strong performance for our technology. We'll get into more detail on that effort a little bit later today.

此外，我們正在進行多項幹預性試驗，以繼續推進該領域的發展，將個人化 MRD 納入標準治療方案。除了 Signatera 之外，我們現在掌握的高級腺瘤數據也讓我們更有信心盡快推進 FDA 批准的 FIND 試驗，以期獲得高品質的結果。該試驗目前正在招募患者。這是一筆巨大的投資，但考慮到電子裝置設計 (ECD) 領域極具吸引力的機會，包括巨大的市場規模、高毛利率以及我們技術非常強勁的表現，我們認為這是值得的。我們稍後會更詳細地介紹這項工作。

Finally, as you can see here on the slide, our SG&A is slightly down sequentially from Q2 to Q3. That largely reflects the fact that we are now in a very good spot with the commercial team and with our revenue cycle operations, which were big areas of SG&A investment in the past. We're now in a position to drive significant scale from these prior investments. As we start to look out to next year, we expect there will be limited OpEx growth of roughly 10%, while revenues grow much faster, and margins continue to improve.

最後，正如您在幻燈片中看到的，我們的銷售、管理及行政費用從第二季到第三季略有下降。這在很大程度上反映了我們目前在商業團隊和收入週期營運方面都處於非常有利的地位，而這些領域在過去是銷售、一般及行政費用投資的重點。我們現在有能力利用先前的投資來實現顯著的規模化發展。展望明年，我們預計營運支出成長將受到限制，約 10%，而營收成長速度將快得多，利潤率將繼續提高。

The OpEx investment will be focused on executing definitive Signatera clinical trials to expand the market and completing the FDA-enabling FIND-ECD study, where we will be enrolling patients in 2026. As we said before, we think these are both very smart investments.

營運支出投資將集中用於執行 Signatera 的最終臨床試驗，以擴大市場，並完成 FDA 批准的 FIND-ECD 研究，我們將在 2026 年招募患者。正如我們之前所說，我們認為這兩項投資都非常明智。

Okay. With that, let me turn it over to Solomon to discuss more details. Solomon?

好的。接下來，我將把發言權交給所羅門，讓他來討論更多細節。所羅門？

Thanks, Steve. Getting into some of our new data and announcements, I want to start with the expansion of our Fetal Focus test. We originally launched Fetal Focus in August with the panel covering 5 of the most common inherited conditions: CF, SMA, Fragile X, alpha-thalassemia and beta-hemoglobinopathies, including sickle cell anemia.

謝謝你，史蒂夫。接下來我想談談我們的一些新數據和公告，首先是我們的胎兒聚焦測試的擴展。我們最初在 8 月推出了「胎兒關注」欄目，涵蓋了 5 種最常見的遺傳性疾病：囊性纖維化、脊髓性肌肉萎縮症、脆性 X 染色體症候群、α-地中海貧血和β-血紅蛋白疾病，包括鐮狀細胞貧血。

The goal of the test is to offer a solution for pregnant mothers who are carriers of one of those inherited gene, but where the father is unavailable for screening to see if the baby might be at increased risk. In these cases, with a simple blood draw, our Fetal Focus test can directly assess the fetal DNA circulating in the mother's blood to detect potential fetal inheritance from both mother and father. This can be done with high sensitivity and specificity, and we believe it is the next best thing when Dad is not available for screening.

該測試的目的是為攜帶這些遺傳基因之一的孕婦提供解決方案，但父親無法進行篩檢，以確定嬰兒是否可能面臨更高的風險。在這些情況下，只需抽取少量血液，我們的胎兒聚焦測試即可直接評估母親血液中循環的胎兒 DNA，以檢測胎兒可能從母親和父親那裡遺傳的基因。這種方法靈敏度和特異性都很高，我們認為當父親無法進行篩檢時，這是次佳選擇。

So the news from last week is that we are expanding the panel to cover 20 of the most common genes and launching that before the end of this year. The validation of this expanded panel, like the original 5-gene panel, leverages prospectively collected samples from the EXPAND trial, which has enrolled over 1,700 high-risk pregnancies from a diverse multi-ethnic population. Where those pregnancies include those with dual inheritance from both parents, partial inheritance from one of the parents or 0 inheritance and confirmed fetal outcomes in all cases based on prenatal or postnatal diagnosis.

上週的消息是，我們將擴大檢測範圍，涵蓋 20 個最常見的基因，並將在今年年底前推出。與最初的 5 基因檢測組一樣，此擴展檢測組的驗證也利用了 EXPAND 試驗中前瞻性收集的樣本，該試驗已招募了來自不同多民族人群的 1700 多例高風險妊娠。這些懷孕包括從父母雙方雙重遺傳、從父母一方部分遺傳或 0 遺傳，所有病例均根據產前或產後診斷確認了胎兒結果。

Testing and confirming all negatives in particular, is critical for a robust estimate of test sensitivity. We use our proprietary LinkedSNP technology to improve detection of challenging homozygous cases, which is where both parents are carrying the exact same mutation in a given gene. This happens with regularity in certain conditions like the classic Delta F508 mutation, which causes cystic fibrosis, if inherited from both parents.

對所有陰性結果進行檢測和確認，對於可靠地估計檢測靈敏度至關重要。我們利用我們專有的 LinkedSNP 技術來提高對疑難純合子病例的檢測能力，即父母雙方在給定基因中攜帶完全相同的突變。這種情況在某些疾病中經常發生，例如經典的 Delta F508 突變，如果從父母雙方遺傳，就會導致囊性纖維化。

LinkedSNP uses information about neighboring DNA loci to work out likely inheritance patterns. We are pleased with the response from the medical community after our initial launch in August, and we know folks are looking forward to this panel expansion so that our Horizon customers can interrogate the cell-free DNA for a broader set of potential inherited conditions.

LinkedSNP利用鄰近DNA位點的資訊來推算可能的遺傳模式。我們對8月首次推出後醫學界的反應感到滿意，我們知道大家都很期待這次檢測範圍的擴大，以便我們的Horizo​​​​n客戶能夠檢測無細胞DNA，從而發現更廣泛的潛在遺傳疾病。

Turning now to oncology, where we had a strong quarter of clinical adoption and new evidence generation. At the ESMO conference, we had 14 abstracts, including 6 orals with a blockbuster readout in muscle invasive bladder cancer across 2 different studies, IMvigor011 and CheckMate 274, both of which also had concurrent publications in the New England Journal of Medicine and Annals of Oncology, respectively.

現在轉向腫瘤學領域，我們在這一季度實現了強勁的臨床應用和新證據的產生。在 ESMO 大會上，我們提交了 14 篇摘要，其中包括 6 篇口頭報告，在兩項不同的研究（IMvigor011 和 CheckMate 274）中，我們在肌層浸潤性膀胱癌方面取得了突破性進展。這兩項研究也分別在《新英格蘭醫學雜誌》和《腫瘤學年鑑》上同時發表。

Many of you tuned in after the conference for our special call with Professor Tom Powles, Director of the Barts Cancer Center in London and Chief Principal Investigator of the IMvigor011 trial, who reviewed the significance and the novelty of this data. For those who could not join that call, the link is on our Investor Relations page. But the summary is that we have generated Level 1A evidence to support the role of Signatera in directing treatment after radical cystectomy.

會議結束後，許多人收聽了我們與倫敦巴茨癌症中心主任兼 IMvigor011 試驗首席研究員 Tom Powles 教授的特別電話會議，他回顧了這些數據的意義和新穎性。未能參加電話會議的各位，會議連結已發佈在我們的投資者關係頁面上。但總而言之，我們已經獲得了 1A 級證據，支持 Signatera 在根治性膀胱切除術後指導治療中的作用。

As the discussant said during the Congress, this is the strongest evidence to date for intervening with adjuvant systemic therapy on the basis of detecting plasma ctDNA. There are 3 more things to note. Number one, the IMvigor011 protocol called for Signatera monitoring every 6 weeks after surgery. This is a serial surveillance protocol, not simply a onetime test.

正如該討論者在大會上所說，這是迄今為止基於檢測血漿 ctDNA 而進行輔助全身治療幹預的最有力證據。還有三點要注意。第一，IMvigor011 方案要求術後每 6 週進行一次 Signatera 監測。這是一個連續監測方案，而不僅僅是一次性測試。

Number two, patients who tested positive with Signatera at any time in that first year after surgery, derived significant benefit from immunotherapy, improving overall survival by 41%, while patients who remain negative derived no treatment benefit and had excellent outcomes with no treatment at all, achieving 97% overall survival at 24 months.

第二，在手術後第一年內任何時間檢測出 Signatera 呈陽性的患者，從免疫療法中獲益匪淺，總生存率提高了 41%；而檢測結果始終為陰性的患者，則未從治療中獲益，即使不接受任何治療，也取得了極佳的療效，24 個月時的總生存率達到了 97%。

Number three, the result was consistent across cohorts, IMvigor011 with atezolizumab and CheckMate 274 with nivolumab. And Signatera is expected to have a role in postsurgical care regardless of the neoadjuvant treatment regimen. As perioperative care is expected to grow in popularity, which is treatment both before and after surgery, questions will always remain about which patients benefit the most from additional systemic therapy after surgery, which can often be hard for patients to tolerate.

第三，各組的結果一致，IMvigor011 使用阿特珠單抗，CheckMate 274 使用納武利尤單抗。無論採用何種新輔助治療方案，Signatera 都有望在術後護理中發揮作用。隨著圍手術期護理（包括術前和術後治療）的普及，人們總是會質疑哪些患者最能從術後額外的全身性治療中獲益，而這種治療往往是患者難以耐受的。

As a reminder, the median age of diagnosis in the U.S. for muscle invasive bladder cancer is 73 years old. Ultimately, each doctor and patient will have to make their own informed decisions, and now they can look to Signatera MRD status for additional guidance. We expect this data to fuel adoption of Signatera among GU oncologists and to have a positive halo effect on the overall field and further to differentiate Signatera.

提醒大家，在美國，肌肉層浸潤性膀胱癌的診斷年齡中位數為 73 歲。最終，每位醫生和患者都必須做出自己知情的決定，現在他們可以參考 Signatera MRD 狀態來獲得更多指導。我們期望這些數據能夠促進泌尿生殖系統腫瘤醫師對 Signatera 的採用，並對整個領域產生積極的光環效應，進一步使 Signatera 脫穎而出。

Among the other readouts at ESMO, the colorectal data was also notable. Data from the INTERCEPT study and the NICHE study were presented. Both showed that Signatera dynamics and particularly MRD clearance during or after therapy were reliable markers of therapy response.

在 ESMO 公佈的其他數據中，大腸直腸癌數據也值得關注。展示了 INTERCEPT 研究和 NICHE 研究的數據。兩項研究均表明，Signatera 的動態變化，特別是治療期間或治療後的 MRD 清除情況，是治療反應的可靠標誌。

In the INTERCEPT study, they followed ctDNA patterns from over 1,300 colorectal cancer patients, showing the rates of clearance after adjuvant therapy and what it meant. In this cohort, adjuvant therapy achieved MRD clearance in approximately one fourth of the patients who had tested positive after surgery. And it was very rare for a clearance to occur spontaneously without treatment only 2% to 4% of the time. This makes Signatera extremely reliable for evaluating response to adjuvant therapy.

在 INTERCEPT 研究中，他們追蹤了 1300 多名大腸癌患者的 ctDNA 模式，顯示了輔助治療後的清除率及其意義。在該組患者中，輔助治療使約四分之一術後檢測呈陽性的患者實現了微小殘留病灶清除。而且，無需治療即可自發性清除的情況非常罕見，只有 2% 到 4% 的機率。這使得 Signatera 在評估輔助治療反應方面極為可靠。

In the NICHE study published concurrently in the journal Nature, the investigators conducted an in-depth analysis of response to neoadjuvant immunotherapy in patients with MMR proficient colon cancer. While they identified novel predictive signatures based on TP53 status, immune cell proliferation and whole genome duplication, the study also showed the power of Signatera dynamics to predict response. Out of the 6 patients who achieved response based on pathologist review of their resected tumor, 5 out of 6 had cleared their ctDNA prior to surgery.

在與《自然》雜誌同期發表的 NICHE 研究中，研究人員對 MMR 功能正常的結腸癌患者接受新輔助免疫療法的反應進行了深入分析。雖然他們根據 TP53 狀態、免疫細胞增殖和全基因組複製確定了新的預測特徵，但該研究也顯示了 Signatera 動態在預測反應方面的強大能力。根據病理學家對切除腫瘤的審查，6 名患者中有 5 名在手術前已清除 ctDNA。

And out of the 20 patients who failed to achieve pathological response, 19 out of 20 were still ctDNA positive prior to surgery. This all points towards the clinical utility of using Signatera in the neoadjuvant setting to inform the surgical and adjuvant treatment plan. Both of these studies together with similar evidence in other cancer types, all tell a growing story of Signatera supporting a new type of surrogate endpoint to hopefully accelerate future drug approvals as well.

在 20 名未能達到病理反應的患者中，有 19 名在手術前 ctDNA 檢測仍呈現陽性。這一切都表明，在新輔助治療中使用 Signatera 可以指導手術和輔助治療方案，具有臨床實用性。這兩項研究以及其他癌症類型的類似證據，都表明 Signatera 支持一種新型的替代終點，有望加快未來藥物的審批速度。

While Signatera had a successful showing at ESMO, there were other ctDNA-guided trials using other assays that did not hit their endpoints, for example, in colorectal cancer and lung cancer. We believe this underscores the differences between ctDNA assays and technologies as well as differences in trial designs. As several presenters noted explicitly during the ESMO conference, study results are not necessarily transferable between ctDNA assays.

雖然 Signatera 在 ESMO 上取得了成功，但其他使用其他檢測方法的 ctDNA 指導試驗並未達到其終點，例如在結直腸癌和肺癌方面。我們認為這突顯了 ctDNA 檢測和技術之間的差異，以及試驗設計上的差異。正如幾位演講者在 ESMO 會議上明確指出的那樣，ctDNA 檢測的研究結果不一定能相互轉化。

The field is coming to appreciate that there can be significant differences in performance between different technologies. It is not enough to measure simply analytical assay performance using controlled mixture experiments in a research lab. It is critical that assays be rigorously evaluated in well-designed prospective clinical studies, especially when they're going to inform life and death treatment decisions.

該領域逐漸意識到，不同技術之間的性能可能存在顯著差異。僅僅在研究實驗室中使用受控混合物實驗來測量分析檢測性能是不夠的。檢測方法必須在精心設計的前瞻性臨床研究中進行嚴格評估，這一點至關重要，尤其是在這些檢測方法將影響生死攸關的治療決策時。

As a reminder, Signatera is unique in that we use a patented multiplex PCR amplification technique followed by next-gen sequencing, which identifies a targeted set of clonal mutations with the lowest background error rates and sequencing the plasma at extreme depths with over 100,000 reads per target. By contrast, other labs may use hybrid capture techniques that are broad and shallow, tracking hundreds or even thousands of mutations, but sequencing them at shallow depth.

需要提醒的是，Signatera 的獨特之處在於我們使用專利的多重 PCR 擴增技術，然後進行下一代定序，從而以最低的背景錯誤率識別一組目標克隆突變，並以極高的深度對血漿進行測序，每個目標超過 100,000 次讀取。相較之下，其他實驗室可能使用廣泛而淺層的雜交捕獲技術，追蹤數百甚至數千個突變，但定序深度較淺。

Test performance is based on more than the number of targets. We see this over and over again. It depends on the chemistry, the variant selection and the calling algorithms. All of this helps solidify Signatera's role in cancer care. It will also give rise to a new wave of clinical trials, treating patients only on molecular recurrence and using Signatera dynamics to evaluate treatment response.

測試性能不僅取決於目標數量。這種情況我們屢見不鮮。這取決於化學性質、變異選擇和調用演算法。所有這些都有助於鞏固 Signatera 在癌症治療領域的地位。它還將引發新一輪臨床試驗，僅針對分子復發的患者進行治療，並使用 Signatera 動力學來評估治療反應。

With that, I want to turn it over to Alex to discuss our exciting road map in early cancer detection. Alex?

接下來，我想把麥克風交給 Alex，讓他來談談我們刺激的早期癌症檢測路線圖。亞歷克斯？

Thanks, Solomon. Colorectal cancer is both common and highly preventable when detected early before or right as the cancer develops. Traditional screening works, but participation is uneven. That's why there's intense interest in accurate, convenient blood-based screening options. We have leveraged our experience at over 250,000 early-stage tumor sequence to date to drive deep discovery in order to find a proprietary set of markers that differentiate colorectal cancer and precancerous advanced adenoma lesions from healthy controls.

謝謝你，所羅門。大腸直腸癌很常見，但如果能在癌症發展初期或發展過程中早期發現，則高度可預防。傳統篩選方式有效，但參與度不均衡。正因如此，人們對準確、便捷的血液篩檢方法產生了濃厚的興趣。我們利用迄今為止超過 250,000 個早期腫瘤序列的經驗，推動深入發現，以找到一組專有的標記物，將結直腸癌和癌前晚期腺瘤病變與健康對照區分開來。

We estimate that the vast majority of these markers are currently not discoverable if only publicly available data sets are utilized. Furthermore, we have embraced an advanced adenoma first approach, focusing our discovery and algorithm development in order to prioritize performance in the difficult-to-detect advanced adenoma lesions. Lastly, we have invested considerable resources to optimize our methylation technology platform to maximize molecular recovery and prevent signal degradation.

我們估計，如果僅使用公開的資料集，目前絕大多數此類標記是無法發現的。此外，我們採取了先檢測高級腺瘤的方法，將我們的發現和演算法開發重點放在提高難以檢測的高級腺瘤病變的性能上。最後，我們投入了大量資源來優化我們的甲基化技術平台，以最大限度地提高分子回收率並防止訊號降解。

Taken together, this allows us to detect signals significantly below 0.01% VAF, a range that is required to improve advanced adenoma sensitivity. PROCEED-CRC is a U.S. prospective study of approximately 5,000 average-risk asymptomatic screening participants who provided blood pre-colonoscopy. In the most recent analysis focused on advanced adenomas that was derived from 1,400 sequential participants with clinical outcomes, we reported a 22.5% sensitivity and a 91.5% specificity.

綜合來看，這使我們能夠檢測到遠低於 0.01% VAF 的訊號，這是提高晚期腺瘤敏感性所必需的範圍。PROCEED-CRC 是一項美國前瞻性研究，研究對象為約 5,000 名平均風險的無症狀篩檢參與者，他們在大腸鏡檢查前提供了血液樣本。在最近一項針對 1400 名連續參與者的臨床結果分析中，我們重點關注了晚期腺瘤，結果顯示其敏感性為 22.5%，特異性為 91.5%。

Furthermore, when adjusting performance for histological subtype prevalence in recent FDA-enabling trials, sensitivity remained in the approximate 22% to 24% range. This is a step-up from earlier 2025 pilot data readout, which showed an 18% sensitivity at a 91% specificity after technological and algorithm refinements. We have heard some questions about if this sample set is representative of the FDA-enabling study. We want to reiterate that these samples were collected in the same fashion and from the same funnel as the FDA-enabling FIND study.

此外，在最近獲得 FDA 批准的試驗中，根據組織學亞型盛行率調整效能時，敏感性仍保持在 22% 至 24% 左右的範圍內。這比 2025 年早些時候的試點數據讀數有了顯著提高，該讀數顯示，經過技術和演算法改進後，靈敏度為 18%，特異性為 91%。我們收到了一些關於該樣本集是否能代表FDA批准研究的疑問。我們想重申，這些樣本的採集方式和所用漏斗與獲得 FDA 批准的 FIND 研究相同。

Furthermore, we know that sample processing occurred in a blinded fashion and the size distribution was potentially more challenging than what we expect in a larger cohort. Before we dive into the data, it's important to understand the types of advanced adenomas that are precursors to colorectal cancer and why their detection is clinically challenging.

此外，我們知道樣本處理是在盲法下進行的，而且樣本大小分佈可能比我們在更大樣本群體中預期的更具挑戰性。在深入研究數據之前，了解哪些類型的晚期腺瘤是結直腸癌的前兆，以及為什麼臨床上難以檢測這些腺瘤，是非常重要的。

Advanced adenomas are precancerous polyps that can vary significantly in size, structure and cellular composition. These include four main subtypes: number one, the rated adenomas, which are flat and often more difficult to detect visually. Number two, tubular adenomas, the most common but typically smaller and less aggressive subtype. Number three, villous or tubulovillous adenomas, which have a high malignant potential due to greater percentage of villous architecture.

高級腺瘤是癌前息肉，其大小、結構和細胞組成可能有顯著差異。這些包括四種主要亞型：第一種是分級腺瘤，它們是扁平的，通常更難用肉眼檢測到。第二，管狀腺瘤，是最常見的亞型，但通常較小且侵襲性較低。第三類是絨毛狀或管狀絨毛狀腺瘤，由於絨毛結構比例較高，因此具有較高的惡性潛能。

And lastly, number four, advanced adenomas with high-grade dysplasia, which represent the highest risk of transformation to colorectal cancer. When looking at adenoma subtype, 78% of lesions in our cohort were serrated or tubular, consistent with the 74% to 78% range observed in other large studies. This alignment indicates that our cohort is representative of real-world advanced adenoma biology, further validating that our results are representative and not driven by an unusually favorable distribution.

最後，第四類是伴隨高級別異型增生的進展期腺瘤，這類腺瘤轉化為大腸直腸癌的風險最高。從腺瘤亞型來看，我們隊列中 78% 的病變是鋸齒狀或管狀的，這與其他大型研究中觀察到的 74% 到 78% 的範圍一致。這種一致性表明我們的隊列具有真實世界晚期腺瘤生物學的代表性，進一步驗證了我們的結果具有代表性，而不是由異常有利的分佈所驅動的。

In addition to histological subtype, detection rates can also vary by lesion size as smaller or flatter lesions are notably more challenging for blood-based screening methods to detect. In our PROCEED-CRC study, the mean AA size was 13.7 millimeters, notably smaller than the greater than 15-millimeter average reported size in other FDA-enabling studies.

除了組織學亞型外，檢出率也會因病灶大小而異，因為較小或較扁平的病灶對於基於血液的篩檢方法來說，檢出難度明顯更大。在我們的 PROCEED-CRC 研究中，平均 AA 大小為 13.7 毫米，明顯小於其他 FDA 授權研究中報告的大於 15 毫米的平均大小。

Despite the smaller lesion size, which is typically associated with lower detection rates, our results demonstrate promising sensitivity. In summary, the PROCEED readout underscores Natera's commitment to advancing early detection through a data-driven approach, a showing promising detection rates even under very stringent clinical conditions, laying the groundwork for improved colorectal cancer prevention outcomes.

儘管病灶較小（通常與較低的檢出率相關），但我們的結果顯示出令人鼓舞的敏感性。總而言之，PROCEED 的讀數凸顯了 Natera 致力於透過數據驅動的方法來推進早期檢測，即使在非常嚴格的臨床條件下也顯示出令人鼓舞的檢測率，為改善大腸癌預防結果奠定了基礎。

To move from promising readouts to potential screening tests, Natera has launched FIND-CRC, an FDA-grade validation study targeting approximately 25,000 average-risk adults who provide blood before colonoscopy, targeting approximately 70 screen-detected CRC cases. Primary aims are CRC sensitivity and specificity in people without advanced precancerous lesions.

為了從有希望的讀數到潛在的篩檢測試，Natera 推出了 FIND-CRC，這是一項 FDA 級別的驗證研究，目標是約 25,000 名平均風險成年人，他們在結腸鏡檢查前提供血液樣本，目標是篩檢約 70 例 CRC 病例。主要目標是檢測無晚期癌前病變族群的 CRC 敏感性和特異性。

Secondary aims include performance for advanced precancerous lesions for advanced adenoma. The study is designed to generate regulatory-grade evidence that complements and builds upon PROCEED-CRC development data set. The study has enrolled its first patient in May 2025, and we expect enrollment targets to be met over a cumulative 18-month time frame.

次要目標包括對晚期癌前病變和晚期腺瘤的治療效果。該研究旨在產生監管層級的證據，以補充和擴展 PROCEED-CRC 開發資料集。該研究於 2025 年 5 月招募了第一位患者，我們預計在累計 18 個月的時間範圍內達到招募目標。

With that, let me turn it over to Mike to review the financials. Mike?

那麼，接下來就交給麥克來審核財務數據吧。麥克風？

Great. Thanks, Alex. The next page is just a summary of the financials compared to last year. We've clearly ramped volumes and revenues while also continuing to transform the gross margin profile of the business. We said a few years ago that long-term gross margins can exceed 70%. And I think the progress we've made this year should give you confidence that we can get there, particularly as oncology overtakes women's health as the largest part of the business over the next few years.

偉大的。謝謝你，亞歷克斯。下一頁只是今年財務狀況與去年同期進行比較的總結。我們已大幅提高了銷售量和收入，同時也持續改善公司的毛利率狀況。幾年前我們就說過，長期毛利率可以超過 70%。我認為我們今年的進展應該讓你們相信我們能夠實現目標，尤其是在未來幾年內，腫瘤學將超過女性健康，成為公司最大的業務部分。

We've also clearly ramped OpEx, but very little of the OpEx increase translates to revenue in the same calendar year. These are not Super Bowl ads meant to drive short-term volume growth. These are primarily investments that are designed to deliver growth in 2026 and beyond, along with the roughly $60 million in accruals that don't repeat every quarter, as Steve described.

我們也明顯提高了營運支出，但營運支出增加的幅度很少能在同一年轉化為收入。這些並非旨在推動短期銷售成長的超級盃廣告。這些主要投資旨在實現 2026 年及以後的成長，此外還有大約 6,000 萬美元的應計款項，正如史蒂夫所描述的那樣，這些款項並非每季都會重複出現。

As a result, we are really pleased to be showing leverage in the business with respect to free cash flow generation, and we are significantly bumping up our expectations for cash flow generation for the full year. The balance sheet remains pristine with no permanent debt on the books and the cash flows from operations pushing our cash balance above $1 billion currently.

因此，我們非常高興地看到公司在自由現金流生成方面展現出槓桿效應，並且我們大幅提高了對全年現金流產生的預期。資產負債表依然穩健，帳面上沒有任何永久性債務，經營活動產生的現金流使我們目前的現金餘額超過 10 億美元。

Okay. Let's get to the guide update on the next slide. For the third time this year, we are completely resetting the revenue guide, now ranging from $2.18 billion to $2.26 billion on the strength of the revenues and the volumes we've seen so far this year. The gross margin guide, we are once again bumping up the bottom end of the range 100 basis points to account for the good results we've generated so far this year.

好的。接下來我們來看下一張投影片上的指南更新。今年，我們第三次徹底調整了營收預期，根據今年迄今的營收和銷量，目前的營收預期為 21.8 億美元至 22.6 億美元。鑑於今年迄今取得的良好業績，我們將毛利率預期下限再次上調 100 個基點。

To keep modeling simple, we've forecasted Q4 without true-ups in the revenue or the gross margins as has been our previous practice, although the record cash collections in October position us well for more true-ups when we close the books in Q4.

為了簡化建模，我們預測第四季度時沒有像以前那樣對收入或毛利率進行調整，儘管 10 月份創紀錄的現金回收使我們在第四季度結帳時能夠進行更多調整。

Looking into next year, I think a preliminary way to think about volume growth for women's health and organ health is to post a similar number of growth units as we delivered this year, given the teams are relatively stable in size. And for Signatera units, we continue to think about the last four quarters rolling average as a good goal for unit growth over the course of the year.

展望明年，我認為考慮女性健康和器官健康領域業務量成長的初步方法是，在團隊規模相對穩定的情況下，實現與今年類似的成長量。對於 Signatera 的單位而言，我們仍然認為過去四個季度的滾動平均值是全年單位成長的良好目標。

So of course, there may be some variation quarter-to-quarter. That implies some very healthy quarters for Signatera next year, but we think that's justified given the strength of the team we now have in place and the drumbeat of prospective outcomes data we've continued to deliver.

所以，當然，每個季度之間可能會有一些波動。這意味著 Signatera 明年將迎來幾個非常健康的季度，但考慮到我們目前擁有的強大團隊以及我們不斷提供的預期成果數據，我們認為這是合理的。

On ASPs, I think a reasonable initial forecast would be to hold women's health and organ health ASPs stable with some modest growth built in for Signatera and perhaps the $50 range through the course of the year. Our internal teams are, of course, focused on much better results than that across the board. But even this approach yields some big revenue numbers when paired with the volume scale we are expecting.

關於平均售價，我認為一個合理的初步預測是保持女性健康和器官健康產品的平均售價穩定，同時為 Signatera 產品預留一些適度的成長空間，並可能在一年內達到 50 美元左右。當然，我們內部團隊的目標是在各方面都取得比這好得多的成績。但即便如此，當我們達到預期的銷售規模時，這種方法也能帶來可觀的收入。

On both the SG&A and R&D lines, we are making the bumps that Steve described in his section. Steve pointed out that SG&A was flat to down sequentially in Q3 compared to Q2 and R&D was up on all the additional launch efforts and clinical trial work we took on. We'll remain opportunistic on additional OpEx investments, particularly in R&D and clinical trials, but we think the commercial operations are well scaled now to support continued rapid growth in the coming years.

無論是銷售、管理及行政費用或研發費用，我們都遇到了史蒂夫在他的章節中所描述的問題。史蒂夫指出，第三季銷售、一般及行政費用與第二季相比持平或有所下降，而研發費用則有所上升，這得益於我們開展的所有額外產品上市工作和臨床試驗工作。我們將繼續抓住機會增加營運支出投資，尤其是在研發和臨床試驗方面，但我們認為目前的商業營運規模已經足夠大，可以支持未來幾年的持續快速成長。

Accordingly, I'd expect OpEx growth to grow something more like in the 10% range next year with a bias toward the R&D line. We are in the midst of our budgeting process now, and we'll plan to give another update on 2026 when available early next year. I mentioned cash flow generation as a huge bright spot in our results this year, and we expect to sustainably generate cash again next year as we continue to get scale with top line growth and improving margins.

因此，我預計明年營運支出成長率將在 10% 左右，研發投入將占主導地位。我們目前正在進行預算編制工作，並計劃在明年年初公佈 2026 年的最新進展。我曾提到現金流生成是我們今年業績的一大亮點，我們預計明年隨著營收成長和利潤率提高，我們將持續擴大規模，從而再次實現可持續的現金流生成。

Okay. With that, let me open it up to questions. Operator?

好的。接下來，我將開放提問環節。操作員？

Thank you ladies and gentlemen. We will now begin the question-and-answer session. (Operator Instructions)

謝謝各位女士、先生。現在開始問答環節。（操作說明）

Tycho Peterson, Jefferies.

泰科·彼得森，傑富瑞集團。

Hey, this is Noah on for Tycho. I wanted to start by asking on prenatal. So you guys announced a new Fetal Focus test last week. I guess why is now the right time? What were you hearing feedback-wise on the 5-gene panel? And then looking at the 20-gene panel, how are you thinking about reimbursement there?

大家好，我是諾亞，為您帶來泰科的報道。我想先問一下關於孕期方面的問題。你們上週宣布了一項新的胎兒焦點檢測。我想問，為什麼現在是最佳時機？您從五基因檢測小組得到了哪些回饋？那麼，對於 20 基因檢測，您是如何考慮報銷問題的呢？

Yes. Thanks. It's a good question. So of course, we launched the 5-gene panel earlier this summer, I think August, something in that time frame. That's gone really well. We've gotten great feedback from customers. And now R&D has gotten to the point where we're in a position where we can launch the broader panel, which was always part of our plan. So we're excited about that.

是的。謝謝。這是個好問題。所以，我們當然在今年夏天早些時候推出了 5 個基因檢測板，我想應該是八月左右。進展非常順利。我們收到了客戶的非常好的回饋。現在研發工作已經發展到我們可以推出更廣泛的專家小組的階段，這始終是我們計劃的一部分。我們對此感到很興奮。

We're also excited about the EXPAND clinical trial. This is something that we started several years ago, if you go back and you take a look. This type of trial is really the gold standard where we're prospectively collecting blood tubes and then collecting diagnostic outcomes on both positive and negative samples effectively on all the pregnant patients that enroll into the study. And that's really the gold standard way to run these types of trials. So we're excited for that to read out over time as well. We think that will really be the defining trial in the space.

我們也對 EXPAND 臨床試驗感到興奮。這是我們幾年前就開始做的事情，如果你回顧一下就會發現。這種試驗是真正的黃金標準，我們前瞻性地收集血液樣本，然後有效地收集所有參與研究的孕婦的陽性和陰性樣本的診斷結果。這才是開展此類試驗的真正黃金標準方法。所以我們也期待著隨著時間的推移，結果會是如何。我們認為這將是該領域真正的決定性試驗。

Got it. And then for my follow-up, switching to MRD here coming out of ESMO and the IMvigor readout. How are you thinking about the path to NCC guidelines with some of the clinical utility data you put out and then subsequently, the broader commercial payer adoption?

知道了。然後，我的後續研究轉向了ESMO的MRD和IMvigor讀數。您如何看待您發布的一些臨床實用數據與 NCC 指南的製定路徑，以及隨後更廣泛的商業支付方的採納？

Yeah. So obviously, we're really excited about the data from ESMO, particularly around IMvigor that's been received very well. Alex, do you want to comment on guidelines for a moment and maybe Solomon, if you want to comment as well?

是的。顯然，我們對 ESMO 的數據感到非常興奮，特別是關於 IMvigor 的數據，該數據受到了很好的評價。Alex，你想就指導方針發表一下意見嗎？ Solomon，如果你也想發表意見的話？

Yeah. Thanks, Steve. So we do want to know that the IMvigor011 data is what we call Level 1A clinical data and has been obviously submitted for FDA approval, both for the compound as well as for Signatera as well. If you look at past precedents, typically, if something does go through the FDA process, it is included into the NCCN guidelines.

是的。謝謝你，史蒂夫。因此，我們確實想知道 IMvigor011 數據是否屬於我們所說的 1A 級臨床數據，並且顯然已經提交給 FDA 審批，包括該化合物和 Signatera。如果回顧以往的先例，通常情況下，如果某項內容通過了 FDA 的審批流程，就會被納入 NCCN 指南。

So while we can't really speculate on how CTA will be described NCCN guidelines, we do expect that Signatera and atezo kind of guided by Signatera in this setting will eventually make it into the NCCN guidelines.

因此，雖然我們無法真正推測 NCCN 指南將如何描述 CTA，但我們確實預計 Signatera 和 atezo 在此背景下最終將被納入 NCCN 指南。

Yeah. This is Solomon. I would add, given that the New England Journal paper has already come out, assuming that all the FDA processes are on track, we would expect to see a guideline update at some point mid or late next year.

是的。這是所羅門。我想補充一點，鑑於《新英格蘭醫學雜誌》的論文已經發表，假設FDA的所有流程都在按計劃進行，我們預計明年年中或下半年將會看到指南更新。

Yes. And just on the final point on this on commercial payers, which I think you also asked on. We're definitely starting to see some traction, as Mike mentioned, from commercial payers because of the biomarker bills. But obviously, generating this level of evidence and just the quantity of data that we're generating, we think, puts us in a good spot longer term to have coverage from commercial payers.

是的。關於商業支付方，最後一點我想說一下，我想你也問了這一點。正如麥克所提到的那樣，由於生物標誌物法案的出台，我們確實開始看到商業支付方的一些積極性。但顯然，我們認為，我們所產生的這種程度的證據和數據量，將使我們在長期獲得商業支付方的保障方面處於有利地位。

Dovchenko victual Research. Please go ahead.

多夫琴科食品研究。請繼續。

Hey, good afternoon, guys. And thank you for taking my question. I'm going to keep it to one topic, early cancer detection. First thing is regarding the PROCEED-CRC, advanced adenoma sensitivity, specificity performance, I'm just wondering how important that was to shaping your willingness to invest more in this program? And kind of related to that, generally speaking, are you using the same standards you applied in advancing your NIPT and then MRD programs, two areas where you clearly made the right call to move forward. So that's the first part.

嘿，各位下午好。感謝您回答我的問題。我將只談一個主題，那就是癌症的早期檢測。首先是關於 PROCEED-CRC，即高級腺瘤的敏感性和特異性表現，我想知道這對您決定是否願意在該專案上投入更多資金有多重要？與此相關的是，總的來說，您是否採用了與推進 NIPT 和 MRD 專案時相同的標準？這兩個領域顯然是您做出的正確決定，決定繼續前進。這是第一部分。

Second, how much would you expect to invest in 2026? I'm guessing something like $50 million incremental in that program. And then lastly, I'm curious if you'd be willing to share minimum performance -- minimum viable performance you would consider to move forward with this product from a commercial viability standpoint. Thank you. I'll get back and listen.

其次，您預計在 2026 年投資多少？我估計該項目將新增約 5000 萬美元的資金。最後，我很好奇您是否願意分享一下，從商業可行性的角度來看，您認為推進該產品開發的最低性能要求——最低可行性能要求。謝謝。我稍後會回去聽。

Yes. Thanks, Doug. Yes, all good questions. So I would certainly say the performance that we've achieved definitely shaped our willingness to invest into the program coming out of the JPMorgan conference in the beginning of '25 and then with our initial pilot readout on advanced adenoma. Just -- based on that, we made the decision to initiate the initial stages of the FIND study because we were feeling very positive about the road map of improvements that Alex mentioned on advanced adenoma.

是的。謝謝你，道格。是的，都是很好的問題。因此，我肯定會說，我們在 2025 年初摩根大通會議之後，以及在晚期腺瘤的初步試點結果之後，所取得的成績無疑影響了我們對該計畫的投資意願。正是基於此，我們決定啟動 FIND 研究的初始階段，因為我們對 Alex 提到的晚期腺瘤的改進路線圖感到非常樂觀。

But we didn't fully pull the trigger until we saw this most recent readout from the PROCEED study, which was, I think, a big milestone that we're waiting for. And now based off this and our own internal views of the performance and all the, I think, things that Alex outlined just a few moments ago, we're really full steam ahead on the FIND study. And we're excited about it. We've set everything up the right way. We've gotten a jump start by running the PROCEED study and then having all the ducks in a row to start collecting patients.

但直到我們看到 PROCEED 研究的最新結果，我們才終於下定決心。我認為，這是我們一直期待的一個重要里程碑。現在，基於這一點，以及我們內部對業績的看法，還有我認為 Alex 剛才概述的所有事情，我們正在全力推進 FIND 研究。我們對此感到非常興奮。我們已經把一切都安排妥當了。我們透過進行 PROCEED 研究搶佔了先機，並做好了一切準備，開始招募病患。

And we think we can enroll the trial in 2026 and hopefully be one of the major players in this early cancer detection space, which we think is a really good opportunity. I think from an investment standpoint, I think you're kind of directionally right, just kind of building off what we spent this year I think that kind of makes sense. And from a minimal viable standpoint, we've always said we think we have to have really strong performance to make it worthwhile. And that's what we're seeing right now, very strong performance. We know where our competitors are. And I think that's something we're, of course, keeping in mind.

我們認為我們可以在 2026 年開展試驗，並有望成為早期癌症檢測領域的主要參與者之一，我們認為這是一個非常好的機會。我認為從投資的角度來看，你的方向是對的，在我們今年投入的基礎上繼續發展，我認為這是合理的。從最低可行性角度來看，我們一直認為，我們必須擁有非常強大的性能才能使其值得。而這正是我們目前所看到的，表現非常強勁。我們知道競爭對手在哪裡。當然，我認為我們一直在牢記這一點。

But again, it's a huge market. We've done well in very competitive environments. So we're going to keep our eye on just where we need to be and be pushing as hard as we can to make sure we're setting up for success. Thank you very much.

但話說回來，這是一個龐大的市場。我們在競爭非常激烈的環境中取得了不錯的成績。所以我們會密切注意我們應該達到的目標，並盡我們所能努力確保我們為成功做好準備。非常感謝。

Daniel Brennan, TD Cowen.

Daniel Brennan，TD Cowen。

Great, thank you. Maybe just on Signatera. You've kind of taken up the guide for giving us some color on next year in terms of kind of an 18,000 plus or minus trend line. Maybe can you just unpack a little bit, nice little bump up again this quarter above what you guys were expecting. Just any color? I know you gave some drivers in the prepared remarks, but just can you dig in a little bit specifically, anything unique really stand out?

太好了，謝謝。或許只在 Signatera 上。您已經採納了指導方針，為我們描繪了明年的大致趨勢，即大約 18,000 左右的趨勢線。或許你可以稍微解釋一下，本季業績再次超出了你們的預期，這真是個不錯的成長。任何顏色都可以嗎？我知道你在準備好的演講稿中提到了一些驅動因素，但你能否具體談談，有沒有什麼特別突出的地方？

And if you do hit that kind of 18,000 sequential run rate, which would be a step-up from the prior guide, it is still a decel from what we've seen in the last two quarters. So is there anything in the last 2 quarters that was unusual that would cause the deceleration? Or is it just general conservatism?

即使你真的達到了 18,000 場連續跑動率，這比之前的預期有所提高，但與我們在過去兩個季度看到的相比，仍然是一種減速。那麼，過去兩個季度中是否存在任何異常情況導致了增速放緩？或者，這只是普遍的保守主義？

Yes, good question. I mean, look, I think the growth at this point is really just coming across the board. I mean, we're seeing a lot of new customers coming on using Signatera for the first time. We're seeing existing accounts and doctors extend their usage. We're seeing new histologies come on. And I think what's really remarkable is just, I think, the very low penetration that we're in right now. I think despite all of our success, I mean, we're still kind of in these very low single digits when you look at overall penetration, including recurrence monitoring. So there's a long way to go.

是的，問得好。我的意思是，你看，我認為目前各方面的成長都是全面實現的。我的意思是，我們看到很多新客戶第一次使用 Signatera。我們看到現有帳戶和醫生都在延長使用期限。我們看到新的組織學方法正在出現。我認為真正令人驚訝的是，我們目前的滲透率非常低。我認為，儘管我們取得了所有成功，但從整體滲透率（包括復發監測）來看，我們的滲透率仍然非常低，只有個位數。所以還有很長的路要走。

And as long as we keep putting out high-quality data, I think we're going to be in a great position. In the last couple of quarters, we've seen really strong numbers on new patients coming in, which I think has been, I think, significantly more than what we've seen historically. And any time you see like a very sharp uptick, it's something that you always have to kind of think, okay, well, that may normalize over time.

只要我們持續發布高品質的數據，我認為我們就會處於非常有利的地位。在過去的幾個季度裡，我們看到新患者的數量非常強勁，我認為這比我們以往看到的要多得多。每當你看到急劇上升時，你總是要想，好吧，隨著時間的推移，這種情況可能會恢復正常。

But I'll tell you just as we started Q4, I mean, obviously, Mike mentioned this as well in the prepared remarks, I mean, we're seeing that same strong trend on new patients continue. So there seems to be a lot of interest but just having been -- having all been in the space for a long time, we know it's not always a straight line up. And I think kind of the way that Mike put the framework in place is the right framework to think about, but we hope to exceed that as we have been doing thus far.

但我要告訴你們，就像我們剛開始進入第四季度一樣，我的意思是，很明顯，麥克在準備好的發言稿中也提到了這一點，我的意思是，我們看到新患者數量的強勁增長趨勢仍在繼續。所以看來大家對此很感興趣，但是我們在這個領域待了很久，我們知道事情並不總是一帆風順的。我認為麥克所建構的框架是正確的思考框架，但我們希望能夠超越它，就像我們迄今為止所做的那樣。

That was super helpful. And maybe just kind of staying on Signatera, if you don't mind. Just you talked about the biomarker bills as Mike gave the $50 kind of price increase over the course of the year through the end of '26 is like a decent starting point. And you talked about early progress and you guys have been signaling that for a little bit. Can you just spend a little more time on it?

那真是太有幫助了。如果你不介意的話，或許可以繼續留在 Signatera 上。剛才你談到了生物標誌物帳單，Mike 表示，到 2026 年底，價格將上漲 50 美元左右，這算是一個不錯的起點。你們談到了早期進展，而且你們也已經展現出這種跡像一段時間了。你能再多花點時間嗎？

I guess our thinking was when and if biomarker bills begin to have an impact, it could be a bit of a domino effect. Would be tough for a payer to cover something in Texas and not in the adjacent states. So just any more color on specifically what you're seeing? And is that still a potential in '26? Or do you think it's going to take longer for biomarker bills to really kick in? Thank you.

我想我們當時的想法是，如果生物標記法案開始產生影響，可能會引發一系列連鎖反應。對於支付方來說，很難在德克薩斯州支付某些費用，卻不在鄰近州支付。所以，能否更詳細地描述一下您所看到的情況？2026年這是否仍有可能？或者你認為生物標誌物法案還需要更長時間才能真正生效？謝謝。

Yeah, Mike, you want to take that?

是啊，麥克，你想拿嗎？

I think that there's going to be -- look, I think that you'll have a continued drumbeat from biomarker state reimbursement over the course of '26. I mean I mentioned in my prepared remarks that we've seen the growth that we -- that I'd hope to see in the ASPs from -- for the biomarker states, and that was really based on wins that we had kind of in the spring and in the summer.

我認為，在 2026 年，生物標記國家報銷將會持續不斷地帶來新的進展。我的意思是，我在準備好的發言稿中提到，我們已經看到了成長——我希望在生物標誌州的 ASP 中看到成長——這實際上是基於我們在春季和夏季的成功。

There is something to the idea that, hey, like when you have like these big national plans and they've got to get it set up to cover Signatera in one area, but then not the other and the clinical utility and the cost savings is so obviously there, does that add to the incentive structure for them just to cover the test more broadly. When we end up kind of getting to steady state and we are kind of broadly covered in a pan-cancer setting, which I think is inevitable, I think we'll look back and see this as one of the drivers, but it's -- you won't be able to tease that out versus all of the excellent prospective outcomes data that we've been publishing and that we're going to have in the future. But yes, I think it's a factor.

這種想法是有道理的，例如，當制定大型國家計劃，需要在一個地區覆蓋 Signatera 檢測，但在另一個地區卻不覆蓋時，而 Signatera 檢測的臨床實用性和成本節約顯而易見，這是否會增加他們更廣泛地覆蓋該檢測的動力呢？當我們最終達到穩定狀態，並在泛癌領域得到廣泛覆蓋時（我認為這是不可避免的），我認為我們會回顧過去，並將此視為驅動因素之一，但——你無法將其與我們一直在發布和將來將要發布的所有優秀的預期結果數據區分開來。但沒錯，我認為這確實是個因素。

Great. Thank you.

偉大的。謝謝。

Subbu Nambi, Guggenheim.

蘇布南比，古根漢美術館。

Hi, thank you for taking my question. Solomon, your prepared remarks described the advanced adenoma samples in PROCEED trial. Help us understand why you believe the study is designed in a way to be more predictive as we head into the FIND study readout. That said, what I'm still missing or not understanding is why is your assay different and better able to address what has been an issue for others, low signal abundance and really just the biological limits in ctDNA. What is so unique about your assay?

您好，感謝您回答我的問題。Solomon，你準備的演講稿描述了 PROCEED 試驗中的晚期腺瘤樣本。請協助我們了解您為何認為研究的設計方式更具預測性，以便我們能夠更了解 FIND 研究的結果。也就是說，我仍然不明白或不理解的是，為什麼你的檢測方法與眾不同，能夠更好地解決其他人遇到的問題，即訊號豐度低以及ctDNA的生物學限制。你們的檢測方法有何獨特之處？

Yes, it's a good question. Alex, why don't you take that?

是的，這是個好問題。亞歷克斯，你為什麼不拿走？

Yes. Thank you for the question. I think it's a multitude of factors and also just the dedication of our research team. This has been a multiyear process, and we've really approached this, I would say, from first principles. First of all, it's finding the best biomarkers, prioritizing advanced adenoma as something that we really focused on and not necessarily just CRC by itself.

是的。謝謝你的提問。我認為這取決於多種因素，也離不開我們研究團隊的奉獻精神。這是一個歷時多年的過程，可以說，我們真的是從根本原則出發來著手解決這個問題的。首先，我們要找到最好的生物標誌物，優先關注晚期腺瘤，而不只關注CRC本身。

I think the technology has also advanced in the last few years that has allowed for increased molecular recovery, lower sample loss and also techniques that help differentiate methylated regions that otherwise might have been difficult to pick up. And then I think lastly, it's using the right samples. I think we've benefited tremendously from having access to one of the largest repository of early-stage colon cancer cases with known VAFs from Signatera. So when we're training and designing our assay, we're able to really focus on the cancers that matter and that are traditionally difficult to detect.

我認為近幾年來，技術也取得了進步，提高了分子回收率，減少了樣本損失，並且出現了有助於區分甲基化區域（否則可能難以識別）的技術。最後，我認為關鍵在於使用正確的樣本。我認為，我們能夠訪問 Signatera 提供的最大的早期結腸癌病例庫之一（該庫包含已知 VAF），我們從中受益匪淺。因此，在進行培訓和設計檢測方法時，我們能夠真正專注於那些重要的、傳統上難以檢測的癌症。

And I think that's what's given us a lot of confidence now over multiple readouts that we are on the right track. And I think this study in itself furthermore kind of underscores that, collected in exactly the same fashion, prospective asymptomatic patients, distribution of the advanced adenomas is representative, if not a little bit tougher than you would expect in a much larger study. And we're seeing performance that gives us strong confidence that this is likely to hold up in a larger prospective FDA-enabling study.

我認為正是這一點，讓我們在多次測試結果的基礎上，更加確信我們走在正確的道路上。而且我認為這項研究本身也進一步強調了，以完全相同的方式收集前瞻性無症狀患者，晚期腺瘤的分佈具有代表性，即使比你在更大規模的研究中預期的要困難一些。我們看到的這種表現讓我們非常有信心，這種表現很可能在更大規模的、符合 FDA 審批要求的預期研究中得到驗證。

Very helpful. Thank you so much for that. Quick unrelated follow-up. When should we expect the VEGA trial to read out, the deescalation arm of the GALAXY study?

很有幫助。非常感謝。一個無關的簡短後續問題。我們應該何時才能看到 VEGA 試驗（GALAXY 研究的降階治療組）的結果公佈？

Alex, why don't you jump on that one, too?

亞歷克斯，你為什麼不也參與其中？

Yes. So it's difficult for us to predict exactly when the study is going to read out. It is an event-based readout. I will say that all patients on the VEGA study have been randomized. So we're just waiting for enough events. I think it is safe to say that the readout is likely to occur in 2027. But as we get closer to that, we'll refine that guidance.

是的。因此，我們很難準確預測這項研究何時會公佈結果。它是一種基於事件的讀出方式。我想說的是，VEGA 研究中的所有患者都是隨機分組的。所以我們現在只是在等待足夠的事件發生。我認為可以肯定地說，結果很可能在 2027 年公佈。但隨著目標的臨近，我們會完善相關指導。

Perfect. Thank you so much, guys.

完美的。非常感謝各位。

Casey Woodring, JPMorgan.

Casey Woodring，摩根大通。

Great, thank you for taking my questions. I have a couple of quick ones on Signatera. I was hoping that you guys could split out contribution from new patient starts in the quarter and whether that increased from last quarter? I know you called out strength there last quarter as well. And then today, you've noted an acceleration across multiple tumor types in Signatera. Just curious if you can clarify which tumor types, you're seeing the most strength and if you're seeing any early traction from new data readouts like IMvigor?

太好了，謝謝你回答我的問題。我這裡有幾篇關於 Signatera 的簡短文章。我希望你們能單獨分析一下本季新病患就診量的貢獻，以及該貢獻量是否比上個季度有所成長？我知道你上個季度也強調了那裡的優勢。今天，您注意到 Signatera 治療中多種腫瘤類型的進展都加速了。我想請問一下，您能否具體說明一下，您認為哪些腫瘤類型療效最顯著？以及您是否從 IMvigor 等新的數據解讀中看到了任何早期進展？

Yes, it's a great question. So yes, I mean, we had -- I think in Q2, we had sort of said that the growth in new patients was an all-time record, and I think it was something like maybe 2x greater than anything we've ever seen before. And what's incredible is in Q3, we basically saw something similar where we kind of had almost to those same levels of new patients coming in -- new patient starts coming in. Of course, it was I mean -- we had more new patients coming in, but the growth quarter-over-quarter was almost to this record level of growth that we had seen previously. Sorry, I just had to clarify.

是的，這是一個很好的問題。是的，我的意思是，我們——我想在第二季度，我們曾說過新患者數量的增長創下了歷史新高，而且我認為它可能是以前任何時期增長的兩倍左右。令人難以置信的是，在第三季度，我們基本上看到了類似的情況，新患者的數量幾乎達到了相同的水平——新患者開始湧入。當然，我的意思是——我們確實迎來了更多新患者，但季度環比增長幾乎達到了我們之前所見過的創紀錄增長水平。抱歉，我只是想解釋一下。

But yes, so I do think we're seeing a lot of continued interest with new patients coming in. With regards to where we're seeing interest, it's really broad across the board. Where we generate a lot of data, there's a lot of interest. And of course, coming out of the IMvigor announcement, there's been just a ton of interest in bladder. We're getting a lot of inbounds, both interest from pharma companies as well as physicians that are now looking at how they can implement this in either trials or in their practice.

是的，所以我認為我們看到新患者對這種療法的興趣持續高漲。至於我們看到的興趣點，那真是非常廣泛。凡是產生大量數據的地方，都會有很多人關注。當然，自從 IMvigor 發布以來，人們對膀胱問題產生了濃厚的興趣。我們收到了很多諮詢，既有製藥公司的關注，也有醫生對如何在試驗或實踐中應用這項技術的興趣。

Got it. That's helpful. And then just my quick follow-up here. I appreciate the top line and OpEx color on '26, but can you just talk about gross margins? How should we think about those, especially as Signatera becomes a larger part of the mix? Would you expect those to step up at a similar rate as they did here in '25? Would that be a good benchmark? Thank you.

知道了。那很有幫助。然後我再簡單補充一點。我很欣賞 2026 年的營收和營運支出數據，但您能只談談毛利率嗎？我們應該如何看待這些問題，尤其是在 Signatera 在其中扮演越來越重要的角色時？你認為他們會像 2025 年一樣以類似的速度進步嗎？這算是一個好的衡量標準嗎？謝謝。

Yeah, Mike, you want to take that?

是啊，麥克，你想拿嗎？

Yes. I think on the gross margins, I think, first, as I mentioned in the prepared remarks, I think it's just -- it's easier to model if you strip out the true-ups and so you start with kind of the pre-true-up number and anchor to that. And then I think that we can have a reasonably meaningful kind of sequential improvement over the course of next year in gross margin as we continue to grind higher.

是的。關於毛利率，我認為，首先，正如我在準備好的發言稿中提到的，我認為——如果剔除調整項，建模就更容易了，這樣就可以從調整前的數字開始，並以此為基準。然後我認為，隨著我們繼續努力向上發展，明年毛利率可以實現相當有意義的環比成長。

Obviously, it's hard to repeat the same exact rate that we had this year. I think we're up some 4 percentage-points or something like that year-on-year. It's a pretty meaningful change. But I do think that the target remains clear to us. I mean I think we can be in that 70% range over time. And I think even inclusive of the true-ups, I think that 64.9% number that we put up this quarter, that gives you a glimpse of what we're capable of. So I'm feeling very encouraged on gross margins. I do expect improvement next year.

顯然，我們很難再次達到今年這樣的成長率。我認為我們比去年同期增長了大約 4 個百分點。這是一個意義重大的改變。但我認為我們的目標依然很明確。我的意思是，我認為隨著時間的推移，我們可以達到70%的水平。即使考慮到修正後的數據，我認為我們本季取得的 64.9% 的完成率，也能讓您了解我們的能力。我對毛利率感到非常鼓舞。我預計明年情況會有所改善。

Got it. Thanks for taking my questions, guys.

知道了。謝謝各位回答我的問題。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Yeah, hi, guys, thanks for the questions and Congrats on a strong print here. First question is more on the Signatera side. Just trying to understand what the ASP increase or -- is that the assumptions for next year, is that just on biomarker bills? Or are you baking in additional indications that you talked about? So can you -- maybe could you clarify on that point?

嗨，各位，謝謝大家的提問，也祝賀你們這次印出了很棒的作品。第一個問題更與 Signatera 有關。我只是想了解 ASP 的成長幅度是多少，或者——這是對明年的假設，還是僅僅針對生物標記法案？或者，您是否還加入了您之前提到的其他指示？所以您能否－或許您能就這一點澄清一下？

And then on the clinical side, it would be great if Alex could provide more on -- when we look at the PEGASUS and DYNAMIC-III trials out there, given what we've seen with some of the struggle around the escalation, how do you -- how are you thinking about VEGA there? And then I have a follow-up. Thank you.

在臨床方面，如果 Alex 能提供更多資訊就太好了——當我們審視 PEGASUS 和 DYNAMIC-III 試驗時，考慮到我們在劑量遞增方面遇到的一些困難，您——您如何看待 VEGA 呢？然後我還有一個後續問題。謝謝。

Mike, you want to take the ASP call?

麥克，你想接ASP的電話會議嗎？

Yes. So on the ASPs, I mean, honestly, on Signatera if we get -- if we do the things that we think internally we can do on both biomarker states and given all the MolDX submissions that we have in flight, I think we can do better than the $50 I mentioned in the prepared remarks.

是的。所以關於ASP，我的意思是，老實說，在Signatera，如果我們——如果我們做我們認為在生物標誌物狀態內部可以做的事情，並且考慮到我們正在進行的所有MolDX提交，我認為我們可以做得比我在準備好的發言稿中提到的50美元更好。

One thing to note is that again, we will have another kind of reset on ADLT, which would be a modest headwind for us going into next year. So I just want you to be factoring that in. So the $50 represents what I hope will end up being kind of a conservative cast of achieving some fraction of all these opportunities we have ahead of us. Steve kind of talked about this, but we've all been in the space and been together for a long time. And unfortunately, it doesn't always go up into the right. You don't always get 100% of these opportunities to flow in at the time that you want them.

需要注意的是，ADLT 將再次進行某種形式的重置，這將對我們明年的發展構成一定的不利影響。所以我希望你們把這一點考慮進去。所以，這 50 美元代表著我希望最終能夠保守地實現我們面前所有這些機會的一小部分。史蒂夫也談到這一點，但我們都在這個領域工作了很長時間，也一起合作了很長時間。但不幸的是，它並不總是會向右上升。你不可能總是能在你想要的時候獲得100%的機會。

But if you break down MolDX submissions, we have a long track record of being successful with those and then driving ASP improvements off of those. I think the biomarker state is a driver that we started to really show some traction there as well. And then, yes, there's some other opportunities related to potential guideline inclusion with bladder and beyond that could be very exciting as upside. But I think just as an initial kind of preliminary kind of glimpse into '26, I think that's the right starting point.

但如果你仔細分析 MolDX 的提交案例，我們會發現我們在這方面有著長期的成功記錄，並以此為基礎推動了 ASP 的提升。我認為生物標記狀態是我們開始真正取得一些進展的驅動因素。是的，還有一些與膀胱及其他疾病相關的潛在指南納入機會，這些機會可能會帶來非常令人興奮的收益。但我認為，作為 2026 年的初步展望，這應該是一個合適的起點。

Great. And Puneet, thanks for the question regarding VEGA. It's hard for us to comment on other readouts. But I will say that, obviously, assay performance is important, study design is important. I think when VEGA was designed, a lot of thought went into the right approach. I will flag that in VEGA, there was serial testing patients could cross over and get delayed treatment as part of the ALTAIR study. So that's one factor to consider.

偉大的。Puneet，謝謝你提出關於VEGA的問題。我們很難對其他數據發表評論。但我必須說，顯然，檢測性能很重要，研究設計也很重要。我認為在設計 VEGA 時，設計團隊花了很多心思去尋找正確的方法。我要指出的是，在 VEGA 研究中，患者可以進行一系列測試，並作為 ALTAIR 研究的一部分接受延遲治療。所以這是需要考慮的因素之一。

I think the other thing I want to point out is we do benefit a little bit from the fact that GALAXY actually was the basis for enrolling patients into VEGA, and we have been able to see now over a period of multiple years, how the assay has performed in the non-randomized GALAXY patients, which does increase our confidence.

我想指出的另一點是，GALAXY 研究實際上是 VEGA 研究招募患者的基礎，這讓我們受益匪淺。經過多年的觀察，我們已經能夠了解該檢測方法在非隨機 GALAXY 患者中的表現，這確實增強了我們的信心。

And I think lastly, it is a larger study, close to 1,000, if not more patients were randomized. And it's hard for me to obviously predict exactly the outcome, but we remain confident and excited to see the data when it's unblinded in 2027.

最後，我認為這項研究規模更大，隨機分組的患者接近 1000 人，甚至更多。當然，我很難準確預測結果，但我們仍然充滿信心，並期待在 2027 年揭盲時看到數據。

Okay. That's helpful. And then just a follow-up. On the women's health side, we've seen growth from a competitor in the market, mother-only assay that has gained traction. So obviously, you have Fetal Focus product now. Could you talk about the positioning of the product if the sales force is fully trained on it? How can you sort of go into market and capture share. You obviously have a strong commercial position here. So maybe talk about what -- how should we think about that piece of the market and your positioning and growth there? Thank you.

好的。那很有幫助。然後還有一個後續問題。在女性健康方面，我們看到市場上的競爭對手——僅針對母親的檢測——取得了成長，並獲得了市場認可。所以很明顯，你們現在有 Fetal Focus 產品了。如果銷售團隊接受過全面的培訓，您能否談談產品的市場定位？如何進入市場並搶佔份額？顯然，你們在這裡擁有強大的商業地位。那麼或許可以談談──我們該如何看待這部分市場，以及你們在該市場的定位與成長？謝謝。

Yes, it's a good question. So yes, I mean, we've been doing carrier screening for a long time, right? I think we made one of the largest providers of next-gen sequencing-based carrier screening in the U.S. And when you screen the mother, if the mother is positive, then the standard of care is to go screen the father.

是的，這是個好問題。是的，我的意思是，我們已經進行了很長時間的攜帶者篩檢，對吧？我認為我們已經成為美國最大的基於下一代定序技術的攜帶者篩檢服務提供者之一。如果對母親進行篩檢，結果呈陽性，那麼按照標準流程，接下來應該對父親進行篩檢。

Now one of the challenges is that the father is not always available to get tested or maybe not willing to get tested. And so there's -- in those cases, there's a clinical need to be able to directly assess the genetic status of the fetus. And what's great with Fetal Focus now is that we can do that. We launched the 5-gene panel in, I think, August that was received very well. Now we're sort of expanding to the 20-gene offering.

現在面臨的挑戰之一是，父親不一定總是能接受檢測，或可能不願意接受檢測。因此，在這些情況下，臨床上需要能夠直接評估胎兒的遺傳狀況。現在有了 Fetal Focus，我們就能做到這一點，這真是太棒了。我們大約在八月推出了 5 基因檢測板，反應非常好。現在我們正在逐步擴展到 20 個基因的方案。

And of course, this is something we can roll out through our entire customer base. We can roll this out broadly through our existing sales team. And then there's a lot of, I think, competitors that maybe don't have this capability where this gives us another advantage where we have something unique compared to them. And then for the groups that do have it, we think we're positioned very well, both with our technology and with the clinical trials that we've been doing.

當然，我們可以將這項服務推廣到我們所有的客戶群。我們可以透過我們現有的銷售團隊廣泛推廣這項服務。我認為，還有很多競爭對手可能不具備這種能力，這讓我們擁有了另一個優勢，讓我們擁有了與他們相比獨一無二的東西。而對於那些已經擁有這種藥物的族群來說，我們認為我們憑藉著自身的技術和我們一直在進行的臨床試驗，處於非常有利的地位。

So as I said, there's kind of always been competitors in the space, and we've done really well. We're very pleased with our growth in the women's health space. I mean, we can kind of see sort of where others are growing and how we're growing, and we think we're doing very well there. And we think this can actually increase that as we move forward.

正如我所說，這個領域一直都有競爭對手，而我們做得非常好。我們對我們在女性健康領域的成長非常滿意。我的意思是，我們大概能看到其他人的發展方向以及我們自身的發展情況，我們認為我們在這方面做得非常好。我們認為，隨著我們不斷前進，這實際上可以促進這一目標的實現。

Got it. All right, thanks guys. Congrats again.

知道了。好的，謝謝各位。再次恭喜。

Catherine Schulte, Baird.

凱瑟琳舒爾特，貝爾德。

Hey guys, I'll just go ahead and ask both my questions now. First on early detection, we've seen some players start in lung cancer and then move on to multi-cancer applications, and you've expressed interest there as well. Obviously, you want to figure out CRC first, but any updates on your long-term strategy in screening and maybe when we could hear updates on the multi-cancer side?

大家好，那我現在就直接問我的兩個問題吧。首先是早期檢測方面，我們看到一些廠商從肺癌入手，然後轉向多種癌症的治療，您也對此表示了興趣。顯然，你們首先想弄清楚CRC的情況，但關於你們的長期篩檢策略有什麼最新進展嗎？我們什麼時候可以聽到關於多癌種治療的最新資訊？

And then second, on Signatera 2026 volume growth, just to confirm, was your comment to look at the rolling average of the last 4 quarters in terms of sequential unit volume growth, so 18,000 or so? And does that level hold up for the fourth quarter as well? Thanks.

其次，關於 Signatera 2026 年的銷售成長，我確認一下，您是指參考過去 4 個季度的滾動平均銷量增長，也就是大約 18,000 台嗎？那麼第四季也能維持這個水準嗎？謝謝。

Yes. Thanks. So I'll just comment on the first one. I mean, I think the -- our focus right now has been getting the CRC product completed through the clinical trial process and approved on the market. But of course, in the background, we've got a lot of activity going on. And we have an excellent team. And so MSA is something that, of course, we think we would be in a good position to do and to perform well on. So just kind of stay tuned there.

是的。謝謝。所以我只評論第一個。我的意思是，我認為——我們目前的重點是完成 CRC 產品臨床試驗流程並獲得市場批准。當然，在幕後，我們有很多活動正在進行。我們擁有一支優秀的團隊。因此，我們當然認為我們在MSA方面處於有利地位，並且能夠取得好成績。所以請大家繼續關注。

But in the near term, we think there's a big opportunity in CRC, and we think we're going to be one of the major players in this space, and it's an attractive opportunity when you look at ASPs, gross margins and just the clinical need and the total market size.

但就近期而言，我們認為大腸癌領域有很大的機會，我們認為我們將成為該領域的主要參與者之一，從平均售價、毛利率、臨床需求和整體市場規模來看，這是一個很有吸引力的機會。

Mike, do you want to take the second?

麥克，你想選第二個嗎？

Yes.

是的。

Do you want to take the second question on just kind of what we're thinking from a forecast standpoint on Signatera?

您能否回答第二個問題，談談我們從預測角度對 Signatera 的看法？

Yes. Catherine, the way you said that, I think, is right. I mean what I had in mind there is kind of the rolling for the growth -- rolling 4 quarters average for the growth units. And I just stress it's not -- every quarter is not -- it cannot always be up into the right. You don't always exceed that rolling four every quarter, even though we have up to this point. But I think it's -- you got to have some kind of benchmark, I think, for modeling. And I think that's a very healthy one that requires very good execution from our team. And I think if you're able to look at it over the year, like looking back on it, I think we'll be able to hit that bar.

是的。凱瑟琳，我覺得你剛才說的很對。我的意思是，我當時的想法是採用滾動成長法——以 4 個季度的滾動平均值來計算成長單位。我只想強調，並非每個季度都是如此——並非每個季度都是如此——它不可能總是向右上漲。即使到目前為止我們一直做到了，但你也不總是能每季都超過4。但我認為——建模必須要有一定的基準。我認為這是一個非常健康的舉措，需要我們團隊出色地執行。我認為，如果回顧過去一年，我們會發現我們能夠達到那個目標。

Okay. Ladies and gentlemen, that is all the time we have for questions. This concludes the question-and-answer session and today's conference call. We would like to thank you for your participation. You may now disconnect your lines. Have a pleasant day, everyone.

好的。女士們、先生們，提問時間到此結束。問答環節和今天的電話會議到此結束。感謝您的參與。現在您可以斷開線路了。祝大家今天過得愉快。