Natera Inc (NTRA) 2024 Q3 法說會逐字稿

Welcome to Natera's 2024 third-quarter financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, November 12, 2024.

歡迎參加 Natera 2024 年第三季財務業績電話會議。（操作員說明）謹此提醒，本次電話會議於今天（2024 年 11 月 12 日）錄製。

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

我現在想將電話會議轉給財務長 Michael Brophy。請繼續。

Thanks Operator Good afternoon. Thank you for joining our conference call to discuss the results of our third quarter of 2024. On the line I am joined by Steve Chapman, our CEO, and Alexey Aleshin, General Manager of Oncology and Chief Medical Officer. Solomon Moshkevich, President, Clinical Diagnostics, couldn't be here today, but will be joining us again next quarter.

謝謝接線員下午好。感謝您參加我們的電話會議，討論 2024 年第三季的業績。我們的執行長 Steve Chapman 和腫瘤學總經理兼首席醫療官 Alexey Aleshin 也加入了我的行列。臨床診斷總裁 Solomon Moshkevich 今天無法出席，但將於下個季度再次加入我們。

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.

今天的電話會議透過網路直播進行直播。我們將參考已發佈到 Investor.natera.com 的幻燈片簡報。電話會議的重播也將在發布後立即發佈到我們的 IR 網站。

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.

從投影片 2 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（例如我們的營運和財務前景和預測）做出前瞻性陳述。

Our assumptions for that 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.

我們對前景、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期望的假設，包括產品功能、預期發布日期、報銷範圍以及對我們財務和經營業績的相關影響。

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 10K or 10Q and the Form 8K filed with today's press release.

我們提醒您，此類陳述反映了我們根據目前已知因素做出的最佳判斷，實際事件或結果可能存在重大差異。請參閱我們不時向 SEC 提交的文件，包括我們最新的 10K 或 10Q 表格以及隨今天新聞稿提交的 8K 表格。

Those documents identify important risks and other factors that may cause our actual results to differ materially from those contained in or suggested by forward-looking statements. Forward-looking statements made during the call are being made as of today, November 12, 2024.

這些文件確定了可能導致我們的實際結果與前瞻性陳述中包含或暗示的結果有重大差異的重要風險和其他因素。電話會議期間所做的前瞻性陳述截至今天（2024 年 11 月 12 日）。

If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information. 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.

如果今天之後重播或查看此通話，則通話期間提供的資訊可能不包含當前或準確的資訊。Natera 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指導，但不會就本季度的業績提供任何進一步的指導或更新，除非我們在公共論壇上這樣做。

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

在討論我們的財務表現時，我們將引用一些數字或成長變化。除非另有說明，否則每個此類參考均代表同比比較。現在我想把電話轉給史蒂夫。史蒂夫？

Thanks, Mike. Let's get into the highlights on the next slide.

謝謝，麥克。讓我們來看看下一張幻燈片的亮點。

2024 has already been a transformational year for Natera, and I think Q3 represents our best quarter yet. We generated $439.8 million in revenue, up 64% from the third quarter of last year, which represents a record quarter for revenue growth. Volumes continue to grow rapidly, up 24% year over year. We performed about 137,000 (sic - see press release, "137,100") oncology tests in the quarter which is up 54% from last year.

2024 年對 Natera 來說已經是轉型的一年，我認為第三季代表了我們迄今為止最好的季度。我們的營收為 4.398 億美元，比去年第三季成長 64%，創下了季度營收成長紀錄。銷量持續快速成長，較去年同期成長 24%。我們在本季度進行了約 137,000 次（原文如此 - 參見新聞稿，「137,100」）腫瘤學測試，比去年增加了 54%。

Signatera clinical units posted another strong quarter, up 11,400 units sequentially versus Q2. This is the third fastest quarter-over-quarter growth we've had since launch. We also grew a record 48,400 units year on year, which is the best quarter we've ever had in terms of growth units. Our gross margins were 62% in the quarter. Again, a record for us. And after breaking even on cash for a couple of quarters in a row, we generated $34.5 million in cash this quarter, which is of course another important milestone in our evolution.

Signatera 臨床單位再次表現強勁，與第二季度相比連續增加 11,400 個單位。這是自推出以來第三快的季度環比增長。我們還實現了創紀錄的同比增長 48,400 輛，這是我們有史以來增長最快的季度。本季我們的毛利率為 62%。再次為我們創造了記錄。在連續幾季實現現金收支平衡後，本季我們產生了 3,450 萬美元的現金，這當然是我們發展過程中的另一個重要里程碑。

All of this puts us in a position to raise our guidance for the year with revenue expectations now at $1.61 billion to $1.64 billion, that implies about 50% revenue growth for the full year, which would be the fastest full-year growth we've had as a public company and is significantly above our own internal expectations from the beginning of the year.

所有這些使我們能夠提高今年的指導，目前收入預期為 16.1 億美元至 16.4 億美元，這意味著全年收入增長約 50%，這將是我們有史以來最快的全年增長作為一家上市公司，它的表現遠高於我們年初以來的內在預期。

Many of you saw the groundbreaking GALAXY data published in Nature Medicine and concurrently presented at ESMO in September, which delivered outstanding prospective overall survival data in MRD for the first time.

你們中的許多人都看到了在 Nature Medicine 上發表的開創性 GALAXY 數據，並於 9 月在 ESMO 上同時發表，該數據首次提供了出色的 MRD 前瞻性總體生存數據。

We think this data is important because it strongly supports the core indication for MRD testing, adjuvant decision making and recurrence monitoring. In colorectal cancer physicians have moved beyond analytical metrics and clinical validation studies and now expect to see prospective outcomes data like this.

我們認為這些數據很重要，因為它有力地支持了 MRD 檢測、輔助決策和復發監測的核心適應症。在結直腸癌方面，醫生已經超越了分析指標和臨床驗證研究，現在期望看到這樣的前瞻性結果數據。

As a reminder, this took us over four years to generate and we have a median of 24 months clinical follow up, with a good portion of patients having three years of follow up. I'm also pleased to announce the completion of a study using Signatera from the CALGB/SWOG 80702 trial, which is a randomized phase three study in CRC.

提醒一下，我們花了四年多的時間才完成這項工作，我們進行了平均 24 個月的臨床隨訪，其中很大一部分患者進行了三年的隨訪。我還很高興地宣布使用 CALGB/SWOG 80702 試驗中的 Signatera 完成了一項研究，這是一項針對 CRC 的隨機三期研究。

These results have been accepted as a late breaking abstract for the ASCO GI Conference in January. As you saw from our press release, we see this trial as one of the most important in the space given its size, randomized design and indication. As a reminder, the trial is looking at whether Signatera can predict which patients will benefit from escalation of adjuvant therapy and will report on disease free survival and overall survival respectively.

這些結果已被接受為 1 月 ASCO GI 會議的最新摘要。正如您從我們的新聞稿中看到的那樣，鑑於該試驗的規模、隨機設計和適應症，我們認為該試驗是該領域最重要的試驗之一。提醒一下，該試驗正在研究 Signatera 是否可以預測哪些患者將從輔助治療的升級中受益，並分別報告無疾病存活期和總存活期。

Similar to ALTAIR, this will be another trial that is drug dependent and we look forward to sharing results in early 2025. We also expect results from the GSK ZEST trial in breast cancer will be presented at the San Antonio Breast Symposium next month. As a reminder, this trial was terminated in April of 2023 due to low trial enrollment, so it's underpowered.

與 ALTAIR 類似，這將是另一項藥物依賴性試驗，我們期待在 2025 年初分享結果。我們也預計 GSK ZEST 乳癌試驗的結果將在下個月的聖安東尼奧乳房研討會上公佈。提醒一下，由於試驗註冊人數較低，該試驗於 2023 年 4 月終止，因此動力不足。

But we're still looking to see a trend towards improved disease free survival in MRD positive patients treated with Niraparib versus placebo. Okay, let's get on to some of the business trends. The first slide shows Q3 volumes over time and despite the scale of the business, our growth continues to be very strong.

但我們仍然希望看到接受 Niraparib 治療的 MRD 陽性患者與安慰劑相比，無疾病存活率有改善的趨勢。好吧，讓我們來看看一些商業趨勢。第一張投影片顯示了第三季的銷售隨時間的變化，儘管業務規模很大，但我們的成長仍然非常強勁。

In women's health over the past year, we saw significant growth from our direct channel augmented by the Invitae volume we added earlier this year. In addition, we launched our Fetal RhD test at a time of critical need in the prenatal community. We are really seeing strong demand for this test which can help physicians assess the need for medication traditionally given to RhD negative women to prevent potential complications in future pregnancies.

在過去的一年裡，在女性健康方面，我們看到直接管道的顯著增長，加上今年早些時候我們增加的 Invitae 數量。此外，我們在產前社區急需的時候推出了胎兒 RhD 檢測。我們確實看到了對這項測試的強烈需求，它可以幫助醫生評估傳統上給予 RhD 陰性女性的藥物的需求，以預防未來懷孕中潛在的併發症。

As we've spoken about previously, having an RhD test and the timeliness of our launch was important given that OB/GYNs were facing limited supplies of this medication. The launch is also a great example of the passion and commitment of the Natera team rallying to help patients in need.

正如我們之前談到的，考慮到婦產科面臨這種藥物供應有限的情況，進行 RhD 測試和及時推出非常重要。這次發布也是 Natera 團隊團結起來幫助有需要的患者的熱情和承諾的一個很好的例子。

We're excited about the future of the women's health business and we are working hard to help as many patients as possible get access to our differentiated suite of testing. We also had another excellent quarter in Oregon Health with strong volume growth year-on-year. The strength of our peer reviewed evidence and differentiated product pipeline is being received very well by physicians.

我們對女性健康業務的未來感到興奮，我們正在努力幫助盡可能多的患者獲得我們的差異化檢測套件。俄勒岡州健康部門也經歷了另一個出色的季度，銷量較去年同期強勁成長。我們的同行評審證據和差異化產品系列的優勢受到了醫生的好評。

We now have more than 45 peer reviewed papers in Oregon Health, including the largest prospective study published in the field to date. We look forward to continuing to serve physicians and patients as we move forward. On the next slide, we're double clicking on the Signatera clinical volumes.

目前，我們在《俄勒岡健康》雜誌上發表了超過 45 篇同行評審論文，其中包括迄今為止在該領域發表的最大的前瞻性研究。我們期待在前進的過程中繼續為醫生和患者提供服務。在下一張幻燈片上，我們雙擊 Signatera 臨床卷。

We processed 137,000 units in Q3, which includes 130,000 Signatera clinical volumes. This represents growth of about 11,400 units in the quarter, well above our average of between 8,000 and 10,000 units. The volume was one of our best quarters of growth ever. Given sequential quarters tend to have some variability in terms of holidays and number of receiving days. It's also useful to look at the trend year-on-year.

我們在第三季度處理了 137,000 個單位，其中包括 130,000 個 Signatera 臨床量。這意味著本季成長了約 11,400 台，遠高於我們 8,000 至 10,000 台的平均值。該銷量是我們有史以來成長最好的季度之一。連續幾個季度的假期和接收天數往往會有一些變化。查看同比趨勢也很有用。

Q3 clinical units were 48.4000 higher this year compared to Q3 of last year, a record for the company. We're off to a great start in Q4 despite the impact of the hurricane and the trends are continuing to be very positive. Okay, the next slide shows total revenues year-on-year and a sequential quarter trend.

與去年第三季相比，今年第三季的臨床單位數量增加了 48.4000 個，創下了該公司的記錄。儘管受到颶風的影響，我們在第四季度取得了良好的開端，而且趨勢仍然非常積極。好的，下一張投影片顯示了年比總收入和環比趨勢。

We are very pleased to post 64% revenue growth year-on-year. We have $34.5 million in revenue true ups, which is lower than last quarter as expected, and Mike will talk more about that later in the call. Even stripping out those trips would have yielded a growth rate of 50%, which compares very favorably with our fastest growing quarters despite the fact that the revenue base has gotten much larger in the past few years. While the volumes are clearly providing a strong base for growth, ASP improvement continues to contribute to our revenue growth.

我們很高興看到營收年增 64%。我們的收入真實成長為 3,450 萬美元，低於上個季度的預期，麥克將在稍後的電話會議中詳細討論這一點。即使剔除這些旅行也會產生 50% 的成長率，這與我們成長最快的季度相比非常有利，儘管過去幾年收入基礎已經擴大了很多。雖然銷量顯然為成長提供了堅實的基礎，但平均售價的提高繼續為我們的收入成長做出貢獻。

We've seen progress across the board as we've worked hard to improve reimbursement for covered services in women's health and the Signatera ASP continues to improve. It's important to recall that we reached this level without getting any tailwinds for the Women's health guidelines. While we remain optimistic on guidelines for both carrier screening and 22Q, we plan to be successful with or without guidelines, and we're pleased to see that happening.

我們已經看到了全面的進展，因為我們努力改善女性健康承保服務的報銷，並且 Signatera ASP 不斷改進。重要的是要記住，我們達到這一水平時並沒有為婦女健康指南帶來任何順風順水。雖然我們對攜帶者篩選和 22Q 的指導方針保持樂觀，但無論有沒有指導方針，我們都計劃取得成功，我們很高興看到這種情況發生。

Our growth in total company ASPs is also a function of our product mix evolving towards Signatera. That shift in product mix is fueling the evolution of our gross margins as shown here on the next slide. 62% gross margin is a record for us and well above our expectations at the beginning of the year.

我們公司總平均售價的成長也是我們的產品組合向 Signatera 發展的結果。產品結構的轉變正在推動我們毛利率的演變，如下一張投影片所示。 62% 的毛利率創下了我們的記錄，遠高於我們年初的預期。

ASPs were once again very strong across all of our major products and we're pleased to see Signatera ASP step up modestly once again in the quarter compared to Q2. The COGS wins from the first half held steady in Q3 and we delivered a significant gross margin expansion over Q2.

我們所有主要產品的平均售價再次非常強勁，我們很高興看到 Signatera 平均售價在本季與第二季相比再次小幅上升。第三季上半年的銷貨成本保持穩定，我們的毛利率比第二季大幅成長。

The true ups moderated slightly, down to just under $35 million this quarter. This represents excellent execution as the cash receipts exceeded our past expectations. Excluding true ups, underlying gross margins expanded considerably from roughly 55% gross margins in Q2 to over 58% gross margins in Q3.

本季真實成長略有放緩，降至略低於 3,500 萬美元。這代表了出色的執行力，因為現金收入超出了我們過去的預期。在剔除真實上漲因素後，基本毛利率從第二季約 55% 的毛利率大幅上升至第三季的 58% 以上。

Again, that is driven by strong ASPs execution on COGS projects and the continuing mix shift in the business towards Signatera. While reimbursement can fluctuate from quarter-to-quarter, we feel like we are very well positioned to continue to drive margins higher led by Signatera volumes and ASPs continuing to ramp.

同樣，這是由 ASP 對 COGS 專案的強勁執行以及業務向 Signatera 的持續組合轉變所推動的。雖然報銷額可能會因季度而異，但我們認為，在 Signatera 銷量和平均售價持續上升的帶動下，我們處於非常有利的位置，可以繼續推高利潤率。

So accelerating revenues and gross margins coupled with cash collections well in excess of prior expectations are leading us to our first quarter of meaningful cash flow generation. The chart demonstrates quite a journey from Q1 of 2022 where we burned $162 million in a single quarter.

因此，收入和毛利率的加速成長，加上遠遠超出先前預期的現金回款，使我們在第一季實現了有意義的現金流產生。這張圖表顯示了自 2022 年第一季以來的一段相當長的歷程，當時我們在一個季度就燒掉了 1.62 億美元。

The reality is that our strategy has remained the same throughout this timeframe depicted on the chart. We made the big investments required to deliver excellent care for patients and the volumes and reimbursement followed. While we've been very efficient with resources, we've gotten here without big cost cuts that jeopardize the future of our business.

現實情況是，我們的策略在圖表所示的整個時間範圍內保持不變。我們投入了大量資金來為患者提供優質的護理，以及隨之而來的數量和報銷。雖然我們對資源的利用非常高效，但我們並沒有大幅削減成本，從而危及我們業務的未來。

In fact, as Mike will cover in the guide, we've continued to invest in future growth by adding meaningful investments to our R&D and commercial teams. As we look into 2025, we will continue to prioritize innovation and customer service while managing to cash flow break even. We think that's the best approach for patients, for doctors and for the business given the size of the markets that we're in.

事實上，正如麥克將在指南中介紹的那樣，我們透過為我們的研發和商業團隊增加有意義的投資，繼續投資於未來的成長。展望 2025 年，我們將繼續優先考慮創新和客戶服務，同時設法實現現金流收支平衡。考慮到我們所處的市場規模，我們認為這對患者、醫生和企業來說都是最好的方法。

With that, let me hand it over to Alex to provide an update on Oncology. Alex?

接下來，讓我將其交給 Alex 來提供腫瘤學的最新資訊。亞歷克斯？

Thanks Steve. I'm pleased to share some of the recent results from the GALAXY study in colorectal cancer, which we believe were universally excellent across the board, particularly on Signatera's ability to predict overall survival as well as adjuvant chemotherapy benefit in patients with CRC.

謝謝史蒂夫。我很高興與大家分享 GALAXY 研究大腸癌的最新結果，我們相信該研究在各方面都普遍出色，特別是 Signatera 預測大腸直腸癌患者整體存活率以及輔助化療獲益的能力。

As many of you know, GALAXY is part of the Circulate Platform study. We have presented a few datasets thus far which have focused on disease free survival since overall survival takes longer to mature. At the ESMO conference in September and published concurrently in Nature Medicine, we show for the first time an overall survival signal associated with Signatera in a prospective study.

正如許多人所知，GALAXY 是 Circulate Platform 研究的一部分。到目前為止，我們已經提供了一些數據集，這些數據集側重於無病生存，因為總體生存需要更長的時間才能成熟。在 9 月的 ESMO 會議上，我們在一項前瞻性研究中首次展示了與 Signatera 相關的整體生存訊號。

Given that overall survival is such an important metric for oncologists and the gold standard for clinical trials, we view this as a major milestone for the field. There are a few main points I want to highlight for you today. The first is that Signatera was predictive of overall survival.

鑑於整體存活率對腫瘤學家來說是一個非常重要的指標，也是臨床試驗的黃金標準，我們認為這是該領域的重要里程碑。今天我想向大家強調幾個重點。首先，Signatera 可以預測整體存活率。

Patients who tested Signatera positive had a much worse prognosis than Signatera negative patients, around 10 times worse at 36 months. Furthermore, Signatera was the most significant predictor of recurrence as well as overall survival when compared to all known clinical pathological risk factors.

Signatera 檢測呈陽性的患者的預後比 Signatera 陰性患者的預後差得多，36 個月時預後差約 10 倍。此外，與所有已知的臨床病理危險因子相比，Signatera 是復發和總存活期最重要的預測因子。

The second point is that Signatera predicted an overall survival benefit from chemotherapy. The GALAXY results show that if a patient tested Signatera positive and received chemotherapy, they had a superior overall survival with a 50% lower risk of death versus patients who did not receive treatment.

第二點是 Signatera 預測化療會帶來整體存活獲益。GALAXY 結果顯示，如果患者 Signatera 檢測呈陽性並接受化療，與未接受治療的患者相比，他們的整體存活率更高，死亡風險降低 50%。

The study also demonstrated that patients who tested negative had no significant benefit from chemo in terms of OS, highlighting the potential for de-escalation of adjuvant therapy for a large portion of patients. And finally, we looked at Signatera clearance after adjuvant therapy.

該研究還表明，檢測結果呈陰性的患者在總存活期方面並沒有從化療中獲得顯著獲益，這凸顯了對大部分患者輔助治療降級的潛力。最後，我們研究了輔助治療後 Signatera 的清除情況。

We showed that patients who cleared ctDNA and remained Signatera negative had superior outcomes with 24-month overall survival being 100%. In comparison, patients who did not achieve CTA clearance at 24 months had an OS of just 61%.

我們發現，清除 ctDNA 並維持 Signatera 陰性的患者預後良好，24 個月總存活率為 100%。相較之下，24 個月時未獲得 CTA 清除的患者的 OS 僅為 61%。

These findings may allow for personalization of treatment and recurrence monitoring that we hope can fundamentally change how colorectal cancer is managed. So, in summary, we believe these results are incredibly significant and further expand the body of evidence supporting Signatera in CRC.

這些發現可能允許個人化治療和復發監測，我們希望這能從根本上改變大腸癌的治療方式。因此，總而言之，我們相信這些結果非常重要，並進一步擴大了支持 Signatera 治療 CRC 的證據體系。

Moving to the next slide, I'm also happy to provide an update on a key study in colorectal cancer. As per our press release earlier this morning, I'll first summarize the main points and why we believe this is such an important trial.

轉到下一張投影片，我也很高興提供大腸直腸癌一項關鍵研究的最新情況。根據我們今天早上早些時候發布的新聞稿，我將首先總結要點以及為什麼我們認為這是一個如此重要的試驗。

To start, the study is drawn from the CALGB/SWOG 80702 study that we'll refer going forward as the 702 study, a randomized Phase 3, clinical trial in CRC, which evaluated the benefit of adding celecoxib to adjuvant chemotherapy in the postoperative management of patients with stage III colorectal cancer.

首先，該研究取自CALGB/SWOG 80702 研究，我們稱之為702 研究，這是一項針對CRC 的隨機3 期臨床試驗，該研究評估了在術後管理中在輔助化療中添加塞來昔布的益處III 期大腸直腸癌患者。

Individuals in the study were randomized to either receive adjuvant chemotherapy plus placebo or adjuvant chemotherapy plus celecoxib. The original study results published in 2021 showed that the addition of celecoxib did not significantly improve disease free survival in patients with Stage 3, colon cancer.

研究中的個體隨機分配接受輔助化療加安慰劑或輔助化療加塞來昔布。2021 年發表的原始研究結果表明，添加塞來昔布並沒有顯著改善第 3 期結腸癌患者的無疾病存活期。

However, that study was initially run without Signatera. The new analyses used samples from the 702 study to investigate whether Signatera can be utilized to identify a subgroup of patients who may benefit from escalation of adjuvant therapy with the addition of celecoxib.

然而，該研究最初是在沒有 Signatera 的情況下進行的。新的分析使用 702 研究中的樣本來調查 Signatera 是否可用於識別可能受益於添加塞來昔布的輔助治療升級的患者亞群。

This pre-specified analysis included more than 1,000 patients with Signatera CTA status post-surgery, so it will be a sizable readout. We will report on Signatera's ability to predict DFS and OS benefit from the addition of celecoxib. The results have been accepted as a late breaking abstract for ASCO GI along with the results of the ALTAIR study, but we look forward to sharing more details on both in late January.

這項預先指定的分析包括 1,000 多名術後 Signatera CTA 狀態的患者，因此這將是一個相當大的讀數。我們將報告 Signatera 預測添加塞來昔布後 DFS 和 OS 獲益的能力。該結果與 ALTAIR 研究結果一起被 ASCO GI 接受為最新的突破性摘要，但我們期待在 1 月底分享這兩項研究的更多細節。

On this next slide we provide a bit more context on Celecoxib, also known as Celebrex which as I mentioned is a drug being investigated in this trial. Celecoxib is a non-steroidal anti-inflammatory drug or NSAID, and as many of you are likely aware, NSAIDs are class of drugs like aspirin that can be used to relieve pain, reduce inflammation and bring down fevers.

在下一張幻燈片中，我們提供了有關塞來昔布（也稱為西樂葆）的更多背景信息，正如我提到的，塞來昔布是本次試驗中正在研究的一種藥物。塞來昔布是一種非類固醇類抗發炎藥或 NSAID，正如你們許多人可能知道的那樣，NSAID 是一類與阿斯匹靈類似的藥物，可用於緩解疼痛、減少發炎和退燒。

These medicines are widely available, relatively non-toxic and generally low cost. NSAIDs have also shown promise in benefiting certain subpopulations in CRC. For example, several studies suggest that NSAIDs reduce the risk of developing precancerous colon polyps. There's a clear need for additional adjuvant treatment options for patients with colorectal cancer as there has not been a new drug approval in this space for over 20 years.

這些藥物廣泛可用、相對無毒且成本通常較低。非類固醇抗發炎藥也顯示出有望使大腸直腸癌的某些亞群受益。例如，多項研究顯示非類固醇抗發炎藥可降低癌症前結腸息肉的風險。大腸直腸癌患者顯然需要額外的輔助治療選擇，因為該領域已有 20 多年沒有新藥獲得批准。

Our analysis will be the first randomized study to help address this unmet need and we are hopeful that Signatera can help open the door to effective treatment options in colorectal cancer personalized to patients who are most likely to benefit.

我們的分析將是第一個幫助解決這項未滿足需求的隨機研究，我們希望 Signatera 能夠幫助打開大門，為最有可能受益的患者提供個人化的結直腸癌有效治療選擇。

And with that I'll turn it over to Mike. Mike?

然後我會把它交給麥克。麥克風？

Great. Thanks, Alex. The next slide is just a summary of the P&L in Q3 and the year-over-year progress. Steve covered the trends on revenues and gross margins, which, I think, is set in stark relief on this slide. We really are in a completely different place in terms of revenue scale and gross margins compared to where we were even just a year ago, which at the time was actually a very good result.

偉大的。謝謝，亞歷克斯。下一張投影片只是第三季損益表和年比進展的總結。史蒂夫介紹了收入和毛利率的趨勢，我認為這在這張投影片上得到了明顯的體現。與一年前相比，我們的收入規模和毛利率確實處於完全不同的水平，這在當時實際上是一個非常好的結果。

R&D, we've grown as we've staffed up to accelerate the tempo of new product launches and additional clinical trials. SG&A has also stepped up meaningfully, although a significant chunk of the step-up is related to litigation expenses and non-cash charges related to stock-based comp.

研發方面，隨著我們配備人員以加快新產品發布和其他臨床試驗的節奏，我們也不斷發展。SG&A 也顯著增加，儘管增加的很大一部分與訴訟費用和與股票比較相關的非現金費用有關。

We, of course, added the Invitae women's health sales team this year, and we've made steady investments in Signatera commercial operations through the course of the year. Despite all those investments, you'll note that the loss per share narrowed significantly as our strategy continues to play out.

當然，我們今年增加了 Invitae 女性健康銷售團隊，並且我們在這一年中對 Signatera 商業營運進行了穩定的投資。儘管進行了所有這些投資，您會注意到，隨著我們的策略繼續發揮作用，每股虧損顯著收窄。

That's consistent with the positive cash flow generation we posted in the quarter that you see at the bottom of the slide. Related to the cash flow generation, I was very pleased to see the days sales outstanding dropped again dramatically to approximately 73 days in Q3 after hovering in the mid-90s range for several quarters previously.

這與我們在幻燈片底部看到的本季發布的正現金流產生一致。與現金流生成相關，我很高興看到銷售待售天數在之前幾季徘徊在 90 年代中期之後，在第三季再次大幅下降至約 73 天。

And after we had spiked to above 100 days during the first few quarters of Signatera growth. I wouldn't be surprised to see DSOs and quarterly cash bounce around a lot based on a typical working capital dynamic for our business but we are seeing clearly much more efficient conversion of our coverage services to cash after years of hard work with payers to make this happen.

在 Signatera 成長的前幾季我們飆升至 100 天以上。根據我們業務的典型營運資金動態，如果看到DSO 和季度現金大幅反彈，我不會感到驚訝，但經過與付款人多年的努力，我們清楚地看到我們的承保服務向現金的轉換效率要高得多。

One other key subsequent event to mention is we are very pleased to retire the convertible notes that you actually see here on the slide. At the beginning of the pandemic when the shares were roughly $25, we issued the convertible notes as an insurance policy to make sure that we had cash available to survive whatever might happen as the world was shutting down.

另一個值得一提的重要的後續事件是，我們非常高興地淘汰您在幻燈片上實際看到的可轉換票據。在疫情爆發之初，當時股價約為 25 美元，我們發行了可轉換票據作為保險，以確保我們有足夠的現金來應對全球封鎖期間可能發生的任何情況。

The notes don't mature until 2027, but we were able to retire the note early via a soft call feature given the tremendous share price performance we've delivered since then. This was a purely opportunistic move that cleans up our balance sheet at a time when many other players in our space have convert maturities over the next few years that are massive relative to their market caps.

這些票據要到 2027 年才會到期，但考慮到我們自那時以來取得的巨大股價表現，我們能夠透過軟贖回功能提前註銷該票據。這純粹是一個機會主義舉措，旨在清理我們的資產負債表，而我們這個領域的許多其他參與者在未來幾年內轉換的期限相對於其市值來說是巨大的。

We are now effectively debt free as the UBS line of credit is secured by our own cash and earnings is roughly the same as the cost of the capital. We closed this transaction in October, so the convert will be wiped off the books when we print the 10-K this year. Okay. Good. Let's get to the guide on the next page.

我們現在實際上沒有債務，因為瑞銀的信貸額度是由我們自己的現金擔保的，而且收益與資本成本大致相同。我們在 10 月完成了這筆交易，因此當我們今年印製 10-K 時，轉換者將從帳簿上刪除。好的。好的。讓我們進入下一頁的指南。

As Steve covered, we now expect revenues between $1.61 billion and $1.64 billion, which is up roughly $300 million compared to our initial guide this year and implies continued growth in Q4. We've had very strong volume growth this year, but the revenue growth has really accelerated this year as we've seen strong realized pricing performance in all of the major products.

正如史蒂夫所說，我們現在預計收入在 16.1 億美元到 16.4 億美元之間，比我們今年最初的指導增加了約 3 億美元，這意味著第四季度的持續增長。今年我們的銷售成長非常強勁，但今年的營收成長確實加速了，因為我們看到所有主要產品都實現了強勁的定價表現。

Signatera especially has seen its ASP mature this year. moving from the [800s] in the past to now roughly $1,050 as of Q3. Note that $1,050 number is before the true-ups. That's the kind of organic repeatable number that we anchor on internally. These same drivers are also transforming gross margins, and we now expect full year gross margins in the range of 58% to 61%. We are bumping OpEx to account for elevated litigation and stock-based comp expenses for the year in addition to the fact that we continue to keep our foot on the gas for future growth.

Signatera 今年的 ASP 尤其成熟。截至第三季度，從過去的 [800 美元] 到現在大約 1,050 美元。請注意，1,050 美元的數字是在實際上漲之前的數字。這就是我們內部所依賴的有機可重複數字。這些相同的驅動因素也在改變毛利率，我們現在預計全年毛利率在 58% 至 61% 之間。除了我們繼續保持未來成長的勢頭之外，我們還提高了營運支出，以應對今年訴訟和股票補償費用的增加。

Finally, I'm very pleased to update the guide to cash generation of $50 million to $75 million this year where we started the year expecting to burn about $50 million. So a meaningful swing there. As you think about how this continues into 2025, do keep in mind that there's about $108 million in true-ups baked into Q1 through Q3 revenue actuals now that we would not include in our guide for next year, so the organic underlying range for this year's revenue translates to $1.51 billion to $1.54 billion and gross margins of 56% to 58%. Those results are still well above our initial expectations and form a solid baseline for growth into next year.

最後，我非常高興地更新今年 5,000 萬至 7,500 萬美元現金產生指南，我們在年初預計會消耗約 5,000 萬美元。所以這是一個有意義的搖擺。當您思考這種情況將如何持續到2025 年時，請記住，第一季到第三季的實際收入中約有1.08 億美元的調整，現在我們不會將其納入明年的指南中，因此這一點的有機基礎範圍年收入為 15.1 億美元至 15.4 億美元，毛利率為 56% 至 58%。這些結果仍然遠高於我們最初的預期，並為明年的成長奠定了堅實的基礎。

As in the past, baseline 2025 goal should be to grow the same number of units next year as we have in 2024. From there, I think we'll need to take into consideration the fact that we got a bolus of women's health units from Invitae in Q2, and that same influx of new units won't repeat next year. And then on the plus side, of course, our base Signatera users continue to grow, and we expect to continue to receive recurrence monitoring orders as we continue with those patients on their cancer journey.

與過去一樣，2025 年基線目標應該是明年增加與 2024 年相同的單位數量。從那時起，我認為我們需要考慮到這樣一個事實：我們在第二季度從 Invitae 獲得了一批女性健康單位，而明年不會再出現同樣的新單位湧入。當然，從積極的一面來看，我們的 Signatera 基礎用戶繼續成長，隨著我們繼續幫助這些患者進行癌症治療，我們預計將繼續收到復發監測訂單。

We would typically presume some erosion in women's health ASP pricing. But given the progress we've made this year, I think it's plausible to hold ASPs steady into 2025. We are cautiously optimistic that Signatera ASPs still have room for modest improvement as we continue to see better coverage from Medicare advantage plans and possibly in the second half of the year, we could start to see some additional contributions from commercial volumes where state biomarker laws are in place.

我們通常會假設女性健康的平均售價會出現一些下降。但考慮到我們今年的進展，我認為 ASP 保持穩定到 2025 年是合理的。我們謹慎樂觀地認為，Signatera ASP 仍有適度改善的空間，因為我們繼續看到醫療保險優勢計劃的覆蓋範圍擴大，並且可能在今年下半年，我們可能會開始看到來自各州生物標誌物法律規定的商業量的一些額外貢獻就位。

On OpEx and cash generation, Steve clearly laid out that our priority is to do everything we need to do to serve Signature patients. More commercial operations, more clinical trials and enhancing our menu of offerings. We recognize it's important to remain cash flow positive. But within the best use of that cash for the immediate term is to turn around and reinvest it in the business, particularly in support of Signatera growth.

在營運支出和現金生成方面，史蒂夫明確指出，我們的首要任務是盡一切努力為 Signature 患者提供服務。更多的商業運作、更多的臨床試驗並增強我們的產品目錄。我們認識到保持正現金流非常重要。但短期內該現金的最佳用途是扭虧為盈並將其再投資於業務，特別是支持 Signatera 的成長。

Okay. With that, let's open it up for questions. Operator?

好的。說到這裡，讓我們開始提問吧。操作員？

Thank you (Operator Instructions)

謝謝（操作員說明）

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Yeah. Hey guys. Really strong congrats -- I mean, a strong quarter here, congrats on this. It's great to see the cash generation. Maybe, Mike, first for you or Steve, can you outline the ASP pickup that you're seeing across the product? I know you highlighted Signatera. Can you elaborate how that Signatera ASP can continue to grow?

是的。嘿夥計們。真的強烈祝賀——我的意思是，這裡是一個強勁的季度，祝賀這一點。很高興看到現金的產生。麥克，首先您或史蒂夫，您能概述一下您在整個產品中看到的 ASP 拾取情況嗎？我知道你強調了Signatera。您能否詳細說明 Signatera ASP 如何繼續成長？

And the stability of ASP across the other products, because I think that has come in scrutiny a bit with some of the commercial payers paying closer attention to coverage and ASPs. So wondering if you can elaborate a bit on that? Then I have questions on oncology?

以及其他產品中 ASP 的穩定性，因為我認為這已經受到了一些審查，一些商業付款人更關注覆蓋範圍和 ASP。那麼想知道您是否可以詳細說明一下嗎？那我對腫瘤學有疑問嗎？

Yeah, Mike. You want to take that?

是的，麥克。你想拿那個嗎？

Yeah. Sure. Yeah. Thanks for the question. So on Signatera ASPs, it's really the same kind of talk track that we've discussed previously. I mean you got really rapid movement upward in the Signatera ASPs from the 800s to now, we're at about $1,050 on an organic basis. The path from here, I think there's always puts and takes, and there's always potential for kind of quarter-to-quarter volatility with ASPs.

是的。當然。是的。謝謝你的提問。因此，在 Signatera ASP 上，這實際上與我們之前討論過的談話軌跡相同。我的意思是，從 800 年代至今，Signatera 的平均售價確實快速上升，有機基礎價格約為 1,050 美元。從這裡開始，我認為總是會有看跌期權，平均售價總有可能出現季度波動。

But from here, we feel like there's more room to run in terms of just execution with Medicare advantage payers continue to increase person allowed for covered services with Medicare advantage payers. And then as I mentioned in the prepared remarks, it's going to be a grind, but I think we're cautiously optimistic, maybe second half of next year, you could start to see some additional tailwind in the Signatera ASP as these state biomarker laws have had a chance to kind of go into effect and mature and we've had a chance to interact with payers in terms of getting them online with covering those coverage services as well.

但從這裡開始，我們認為在醫療保險優惠付款人的公正執行方面還有更多的空間，繼續增加醫療保險優惠付款人允許享受承保服務的人數。然後，正如我在準備好的發言中提到的，這將是一項艱鉅的任務，但我認為我們持謹慎樂觀的態度，也許明年下半年，您可能會開始看到Signatera ASP 中的一些額外順風，因為這些州生物標記法律已經有機會生效並成熟，我們也有機會與付款人互動，讓他們在線上涵蓋這些承保服務。

So it looks like a good 18 months or so trajectory for Signatera ASPs. On the rest of the product portfolio, we've actually seen really strong kind of improvement, particularly in the major women's health products, both Horizon in Panorama. And I hear you. I mean I think there's always having just been in the diagnostics business for long enough, you're always kind of thinking about, well, is there some chance for erosion in these more mature products?

因此，Signatera ASP 的 18 個月左右的發展軌跡看起來不錯。在產品組合的其餘部分，我們實際上看到了非常強勁的改進，特別是在主要的女性保健產品中，包括 Horizo​​n in Panorama。我聽到了。我的意思是，我認為在診斷業務中待了足夠長的時間，你總是會想，這些更成熟的產品是否有被侵蝕的機會？

And usually, I'd say, yes. I think just the actuals that we're seeing and just the -- maybe the time on task and the fact that these offerings are more and more enshrined as just kind of without kind of in the standard of care for prenatal health has kind of given us more confidence and a bit more visibility on our ASPs there.

通常，我會說，是的。我認為，我們所看到的實際情況，也許是執行任務的時間，以及這些產品越來越多地被奉為產前健康護理標準的事實，已經給了我們對那裡的ASP 更有信心，也有更多的知名度。

So let me pause there, Steve, I don't know if you have anything else to add.

所以讓我暫停一下，史蒂夫，我不知道你還有什麼要補充的。

No, that's good. I mean, I'll just add, you know, over the last couple of years, we've invested a lot into, improving things like medical appeals, you know, getting the medical records when requested and I think you're seeing some of the benefit of, you know, just executing on those things. And then of course, you know, there's still upside opportunity when we look at some of the tests that we're performing today where we're not really getting paid for example, like 22Q or our testing in the women's health sector or expanding to additional indications in oncology. So I think that it's positive upside opportunity ahead.

不，那很好。我的意思是，我只想補充一點，你知道，在過去的幾年裡，我們投入了大量資金，改善醫療上訴等方面，你知道，根據要求獲取醫療記錄，我認為你看到了一些你知道，執行這些事情的好處。當然，你知道，當我們看看我們今天正在進行的一些測試時，我們仍然沒有真正獲得報酬，例如 22Q 或我們在女性健康領域的測試或擴展到腫瘤學的其他適應症。所以我認為這是未來積極的上行機會。

Got it. That's great. And then on the Signatera, can you elaborate how much of the lift are you seeing from volume growth in the community setting or maybe the tier 2 setting vs when you present data at these conferences, including ESMO, ASCO and others, the lift you get from that is, I assume, is mostly in the community -- in the academic setting, but just trying to parse out where you're seeing the growth and the sustainability of this growth, obviously very strong in the quarter.

知道了。那太棒了。然後，在Signatera 上，您能否詳細說明一下，與您在這些會議（包括ESMO、ASCO 等）上展示數據時相比，您從社區環境或二級環境中的數量增長中看到了多少提升，您獲得的提升我認為，主要是在社區中——在學術環境中，但只是試圖解析您在哪裡看到的增長和這種增長的可持續性，顯然在本季度非常強勁。

Yes, good question. So it's really a mix. I mean we see uplift here in both academic and in the community setting. As we've said, we think about 40% of oncologists are using Signatera today. And so there's still a long way to go. The market is very underpenetrated in sort of the kind of low single-digit penetration. Every time we generate data, I think that just helps bring more and more physicians into the fray.

是的，好問題。所以這確實是一個混合體。我的意思是，我們在這裡看到了學術和社區環境的進步。正如我們所說，我們認為當今大約 40% 的腫瘤科醫生正在使用 Signatera。所以還有很長的路要走。該市場的滲透率非常低，達到了個位數的低滲透率。每次我們產生數據時，我認為這只會有助於讓越來越多的醫生參與其中。

And especially when you're talking about the type of data that we generated with GALAXY, that's exactly what people want to see is this longer-term overall survival data that now kind of we're getting to that level of follow-up where you're hitting that mark where you're kind of meeting the threshold that some of the doctors that have been holding out have been waiting for.

尤其是當你談論我們用 GALAXY 產生的數據類型時，這正是人們想要看到的長期總體生存數據，現在我們正在達到這樣的後續水平：已經達到了這個標準，你已經達到了一些一直堅持的醫生一直在等待的門檻。

And then, of course, we're really excited about data that we're going to have upcoming in the future randomized readouts. So I think there's a long way to go, but we're seeing it from both academic and community.

當然，我們對未來隨機讀數中即將獲得的數據感到非常興奮。所以我認為還有很長的路要走，但我們從學術界和社區都看到了這一點。

Got it. And last one, just Alex, maybe, Alex, the Nature Medicine paper. Where is that most helpful? Is that most helpful for NCCN or is it driving deeper into the clinical practices? And maybe just elaborate what you expect out of the 702 study at ESMO? And then would that study actually give you any further insights into the IMvigor011 study?

知道了。最後一篇，就是亞歷克斯，也許是亞歷克斯，《自然醫學》論文。哪裡最有幫助？這對 NCCN 最有幫助還是會更深入地推動臨床實務？也許只是詳細說明您對 ESMO 702 研究的期望？那麼這項研究實際上會讓您對 IMvigor011 研究有任何進一步的了解嗎？

Sure. Thanks for the question, Puneet. I would say for the Nature Medicine study, it's helpful, I would say, pretty much across the board. I would say, first of all, a lot of doctors have been waiting for OS data. I think DFS is one thing, but actually seeing the assays predicted of patients living longer, I think the whole field has been kind of waiting for a well-powered study to read that out.

當然。謝謝你的提問，普尼特。我想說，對於《自然醫學》研究來說，它幾乎是全面有幫助的。我想說，首先，很多醫生一直在等待作業系統資料。我認為 DFS 是一回事，但實際上看到預測患者壽命更長的檢測結果，我認為整個領域都在等待一項強有力的研究來解讀這一點。

I think the second part for that study is the pharmaceutical market. I think we've really been able to show that DFS dynamics is predictive of overall survival. And that's really the first step to kind of validate a new certain end point. So I think we're seeing a lot of interest in those results. And I think that makes us very confident, right, about some additional readouts that we've been awaiting.

我認為研究的第二部分是醫藥市場。我認為我們確實能夠證明 DFS 動態可以預測整體存活率。這確實是驗證新的特定終點的第一步。所以我認為我們對這些結果很感興趣。我認為這讓我們對我們一直在等待的一些額外讀數非常有信心，對吧。

I think the 702 study, I think, will kind of defer commenting on the outcome of that until the embargo is listed for ASCO GI. But again, it's over 1,000 patients. It was a well design perspective randomized study. So we're excited to share those results when we're able to. And then for IMvigor011, I think that's on track. We'd expect our partner Genentech to probably read out those results in probably the first half of 2025.

我認為 702 研究會推遲對結果發表評論，直到 ASCO GI 列入禁運名單。但同樣，有超過 1,000 名患者。這是一項設計良好的隨機研究。因此，我們很高興能夠在可能的情況下分享這些結果。然後對於 IMvigor011，我認為一切都步入正軌。我們預計我們的合作夥伴 Genentech 可能會在 2025 年上半年公佈這些結果。

Dan Brennan, TD Cowen.

丹布倫南，TD·考恩。

Congrats on the quarter. Maybe first one just on Signatera price, Mike, the $1,050 nice improvement but a little bit more modest than what we've seen in prior quarters. Can you just speak to -- I know you gave some color in the prepared remarks, just speak to kind of some of the drivers of price from here in particular, like on the biomarker, I know you guys have been -- I felt fairly constructive on what this opportunity could be.

恭喜本季。也許第一個只是關於 Signatera 價格，邁克，1,050 美元的改進很好，但比我們在前幾個季度看到的要溫和一些。你能談談——我知道你在準備好的評論中給出了一些顏色，只是從這裡特別談談一些價格驅動因素，比如生物標記物，我知道你們一直在——我感覺相當不錯對這個機會可能產生的影響具有建設性。

You've had, I think, five states live for over a year. You had three of the biggest states in the country go live in the last month or so. So I'm just wondering what your experience has been and whether or not that could be more of an upside driver and maybe you're kind of making some good services in there?

我想，有五個州已經存在了一年多了。該國最大的三個州在上個月左右上線。所以我只是想知道你的經驗是什麼，這是否會帶來更多的好處，也許你在那裡提供了一些好的服務？

Yeah. No, thanks for the question. No, it's been really constructive so far. I mean the interactions we've had from payers has been quite positive, actually. It's just our experience has been any time you have coverage like this that comes online. It just takes about a year between the time that the coverage comes online to you get some denials back in the door, you appeal those denials, then you kind of get a critical mass of thousands of cases where you've submitted the claim correctly and appeals have been denied.

是的。不，謝謝你的提問。不，到目前為止，這確實很有建設性。我的意思是，實際上我們與付款人的互動非常積極。這只是我們的經驗，任何時候你都會有這樣的線上報道。從覆蓋範圍上線到您收到一些拒絕，您對這些拒絕提出上訴，然後您收到了數千起您正確提交索賠的案件，大約需要一年的時間上訴被駁回。

And then you got to interact with natural human, more senior person at that payer and just work with them on the workflow. And it's been really collaborative so far. So as I said for that, I feel really optimistic about it. But the timeline I gave that's just reflective of the way things work and how long it takes just to get the logistics right. Hopefully, you can come faster but we'll have to see.

然後你必須與付款人的自然人、更資深的人互動，並與他們一起完成工作流程。到目前為止，我們的合作確實非常順利。正如我所說，我對此感到非常樂觀。但我給的時間表只是反映了事情的運作方式以及正確安排物流所需的時間。希望你能快點來，但我們得看看。

In terms of like the pace of the increase, I mean, I think that's an important point. I mean there's kind of no way for us to just increase the Signatera ASP $200 a year forever. I mean, there's a maturity that we tried to get to here as we've kind of gotten into the launch. So that's just a realistic consideration. Having said that, I mean, the gross margins in the products are quite strong. I think they can continue to get stronger. So that, coupled with the data that Alex highlighted on the call today, we're feeling really strong about the Signatera franchise.

就成長速度而言，我認為這是很重要的一點。我的意思是，我們不可能永遠將 Signatera 的 ASP 每年增加 200 美元。我的意思是，當我們已經進入發布階段時，我們試圖達到一種成熟度。所以這只是一個現實的考慮。話雖如此，我的意思是，產品的毛利率相當高。我認為他們可以繼續變得更強。因此，結合 Alex 今天在電話會議上強調的數據，我們對 Signatera 特許經營權感到非常強烈。

Got it. And maybe just one follow-up. Maybe I'll say on the financial side, just on the gross margins, really nice gross margin expansion 400 basis points ex the true-ups. I know you talked about -- Steve talked about in the prepared remarks, some of the only cost initiatives.

知道了。也許只是一個後續行動。也許我會說，在財務方面，就毛利率而言，除真實情況外，毛利率增長了 400 個基點，非常好。我知道你談到 - 史蒂夫在準備好的演講中談到了一些唯一的成本舉措。

you just give some more color on the driver there? Are we starting to see the benefit of the adjuvant surveillance mix shift starting to come through, which is a nice gross margin leverage and I know you kind of updated the full year guide, but as we -- I think you talked a little bit about '25, Mike, in the prepared remarks, but how do we think about the trajectory of gross margins as we kind of turn the calendar into '25?

你只是給司機更多的顏色嗎？我們是否開始看到輔助監控組合轉變的好處開始顯現，這是一個很好的毛利率槓桿，我知道您更新了全年指南，但正如我們 - 我認為您談論了一些'25，邁克，在準備好的發言中，但是當我們將日曆變成'25時，我們如何考慮毛利率的軌跡？

Yeah. I mean I think on the mix shift, that has remained relatively steady. I mean we've seen some move in favor of the recurrence monitoring within the mix. I think what's more important if you're thinking about mix for our corporate gross margins, is the mix between kind of franchises. So for a long time, Panorama was far and away, our biggest product. And now -- first last quarter, but now really this quarter is really the first quarter where Signatera revenues are meaningfully higher than Panorama and it's now our biggest revenue product.

是的。我的意思是，我認為在混合轉變方面，這一直保持相對穩定。我的意思是，我們已經看到了一些支持混合中重複監控的措施。我認為，如果你考慮我們公司毛利率的組合，更重要的是特許經營類型之間的組合。因此，在很長一段時間裡，Panorama 一直是我們最大的產品。現在——首先是上個季度，但現在這個季度實際上是 Signatera 收入明顯高於 Panorama 的第一個季度，它現在是我們最大的收入產品。

So given the margins that we're seeing on Signatera now accreted the corporate gross margins, that itself is kind of driving this kind of corporate gross margin improvement. So I think that trend can continue to move in our favor as far as corporate gross margins go for next year.

因此，考慮到我們在 Signatera 上看到的利潤率現在增加了企業毛利率，這本身就推動了這種企業毛利率的提高。因此，我認為，就明年的企業毛利率而言，這種趨勢可能會繼續對我們有利。

Having said that, I mean, I think it's worth just understanding kind of the prior -- the Steve's first question, which is like what's the kind of rate of increase in ASPs and they have to -- they have to moderate, right? I mean they have to be kind of more kind of steady improvements, and I would expect that to be reflected in the corporate gross margin trajectory as you go into next year as well.

話雖如此，我的意思是，我認為有必要了解之前的問題——史蒂夫的第一個問題，就像平均售價的增長率是多少，他們必須——他們必須進行調節，對嗎？我的意思是，它們必須是一種更穩定的改進，我希望這也能反映在進入明年的公司毛利率軌跡中。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hey guys, good evening. Just a couple of cleanups to start on, perhaps the guidance framework or even just what you're seeing in terms of recent trends in the business, Steve. So First of all, in light of some of the pain the private payers are going through in the Medicare book of business, have you seen any uptick in prior auth or just more documentation required in the last few months across the oncology portfolio I know you mentioned the biomarker middle rollout starting to help a little bit in the back half of next year.

嘿夥計們，晚上好。只需要開始一些清理工作，也許是指導框架，甚至是您所看到的最新業務趨勢，史蒂夫。首先，考慮到私人付款人在醫療保險業務中所經歷的一些痛苦，您是否看到過去幾個月整個腫瘤學投資組合中先前的授權或僅需要更多文件有任何增加，我知道您提到生物標記中間的推出將在明年下半年開始提供一些幫助。

But is there any risk here that some of these private payers might grab their feet on the implementation at all? And then, Mike, just to clean up on the guide really, can you quantify the weather impacts and to what extent that was a little bit of an offsetting factor in the revised guide?

但這裡是否存在一些風險，即其中一些私人付款人可能會根本不參與實施？然後，麥克，為了真正清理指南，您能否量化天氣影響以及在修訂後的指南中這在多大程度上是一個抵消因素？

Yeah. I think a good question on the insurance payers. I mean the good news for us is we've sort of been dealing with all sorts of obstacles for years with respect to payers, whether that's prior authorization, medical records requests just sort of outright denials and then having to appeal and this is something that, like we've developed systems, protocols and processes in order to make sure that we can follow through and just not get kind of bogged down by these various bureaucratic procedures.

是的。我認為關於保險付款人的問題很好。我的意思是，對我們來說，好消息是，多年來我們一直在處理付款人方面的各種障礙，無論是事先授權、醫療記錄請求、只是徹底拒絕，然後不得不上訴，這是，就像我們一樣開發了系統、協議和流程，以確保我們能夠貫徹執行，而不是被這些不同的官僚程序所困擾。

So we've invested heavily there. Over the last couple of years, we've had tons of improvements. And I don't think we've noticed anything really different recently than what we've seen historically. But what we are seeing is that Natera is getting better just responding to those types of things.

所以我們在那裡投入了大量資金。在過去的幾年裡，我們取得了巨大的進步。我認為我們最近沒有註意到任何與我們歷史上所看到的真正不同的事情。但我們看到的是，Natera 對這些類型的事情的反應正在變得更好。

And so I think that was definitely a good investment with regards to the biomarker bills and commercial opportunities, as Mike said, these things take time. And it's good that we have that ahead of us. We've done really well historically and that we still have this upside opportunity from biomarker bill implementation and commercial payer coverage in Signatera.

因此，我認為這對於生物標記物帳單和商業機會來說絕對是一項很好的投資，正如麥克所說，這些事情需要時間。很高興我們有這樣的機會。我們在歷史上做得非常好，並且我們仍然有來自生物標誌物法案實施和 Signatera 商業付款人覆蓋的上升機會。

The other area that Mike didn't highlight earlier, there could be upside opportunity is just getting Medicare coverage in some additional indications. And there's lots of areas where we published that we were in the process of submitting or interacting with Medicare to get additional coverages for Signatera.

麥克之前沒有強調的另一個領域，可能存在上升機會，就是在一些額外的適應症中獲得醫療保險覆蓋。我們在許多領域都發布了我們正在提交或與 Medicare 互動的過程，以獲得 Signatera 的額外承保範圍。

So we think that's an opportunity. And then, of course, when you look back at both in Organ health and then women's health, there's opportunities for ASP improvement, particularly around getting coverage for indications where -- or test today where we currently don't have coverage.

所以我們認為這是一個機會。當然，當你回顧器官健康和女性健康時，你會發現 ASP 有改善的機會，特別是在覆蓋目前沒有覆蓋的適應症方面，或者今天進行測試。

And then, Tejas on the weather -- just on the weather question. We think it's always hard to measure these things with precision. We think we saw a really modest impact to the weather with the hurricanes hitting like that last week in Q3. So that probably had a modest impact on the Q3 results. And I think there was an impact that we saw in October and it remains to be seen what that impact would be for the full quarter.

然後，Tejas 談到天氣——只是關於天氣問題。我們認為精確測量這些東西總是很困難。我們認為上週第三季颶風對天氣的影響非常有限。因此，這可能對第三季的業績產生了一定的影響。我認為我們在 10 月看到了影響，但這種影響對整個季度的影響還有待觀察。

But that -- we've kind of taken that into account. We try to take a kind of a cautious approach to the guide to try and work around that as people kind of not only just weather itself, as people kind of get their homes rebuild and kind of get themselves back into seeing their positions and such?

但我們已經考慮到了這一點。我們試圖對指南採取一種謹慎的態度，嘗試解決這個問題，因為人們不僅要適應天氣本身，還要重建家園，重新認識自己的立場等等？

Got it. Okay. And then one on Signatera and the 702 study guys. How should we be thinking about framing those DFS and OS results in terms of what's clinically meaningful for physicians. And also, given that the results will be dependent on the drug evaluated, obviously, can you provide a little bit of color or context around prior studies that showed CELEBREX on top of standard adjuvant chemo and is a promising approach in certain populations?

知道了。好的。然後是 Signatera 和 702 研究人員。我們應該如何根據對醫生具有臨床意義的內容來建構這些 DFS 和 OS 結果。而且，鑑於結果將取決於所評估的藥物，顯然，您能否提供一些有關先前研究的資訊或背景，這些研究表明塞來昔布優於標準輔助化療，並且在某些人群中是一種有前途的方法？

Yeah, Alex, you want to take that?

是的，亞歷克斯，你想接受嗎？

Yeah, absolutely. Well, I think there's two parts to the question. The first is how well is the drug tolerated, the class of drugs tolerated. And then kind of what could be clinically meaningful in terms of an outcome from the study.

是的，絕對是。嗯，我認為這個問題有兩個部分。首先是藥物的耐受性以及藥物的耐受性。然後就研究結果而言可能具有臨床意義。

I think the good news is that unlike traditional adjuvant chemotherapy, which has significant toxicities, sometimes a risk of death. I think the NSAID class of drugs, of which CELEBREX is one of them, are pretty well tolerated. It's obviously not without side effects completely, but relatively, this is a class of drugs, thousands and millions of folks are taken for other indications. I think what good looks like, I think, obviously, that's going to depend on a few things.

我認為好消息是，與傳統的輔助化療不同，傳統的輔助化療具有顯著的毒性，有時甚至有死亡的風險。我認為 NSAID 類藥物（塞來昔布就是其中之一）的耐受性相當好。顯然它並不是完全沒有副作用，但相對而言，這是一類藥物，成千上萬的人因其他適應症而服用。我認為，顯然，什麼是好的，這取決於一些事情。

How does the readout look in terms of DFS, in terms of OS, and how does it compare to prior studies. I think we've said in the past kind of the last study that led to an approval with a new agent was the MOSAIC study, and had a hazard ratio and kind of 0.75%, 0.77% range for DFS and a very small benefit for OS.

從 DFS 和 OS 角度來看，讀數如何，以及與先前的研究相比如何。我想我們過去曾說過，導致新藥獲得批准的最後一項研究是 MOSAIC 研究，其風險比和 DFS 範圍為 0.75%、0.77%，而對於 DFS 的獲益非常小操作系統。

So we do think that's kind of a good number to think about. I think CELEBREX itself in the initial 702 study without any selection, I think showed a hazard ratio of, I think, around kind of 0.8%, 0.9% range, depending if it was for DFS or OS, and it was obviously not statistically significant. So maybe kind of long answer, but I think the short of it is, we do think anything that's significant below 0.8% hazard ratio for DFS and/or OS and be significant, especially with the class of drugs that's pretty well tolerated.

所以我們確實認為這是一個值得考慮的好數字。我認為 CELEBREX 本身在最初的 702 研究中沒有任何選擇，我認為顯示的風險比約為 0.8%、0.9% 範圍，具體取決於它是針對 DFS 還是 OS，而且顯然沒有統計顯著性。因此，也許答案很長，但我認為簡而言之，我們確實認為任何DFS 和/或OS 風險比顯著低於0.8% 的情況都是顯著的，尤其是對於耐受性良好的藥物類別。

Okay. That's actually really helpful. And Steve, last one for me on screening. We've been getting the question a little bit. Back in September, you talked about being relatively close to sharing that data. And I think you'd also called out that you expect initial proof of concept to be a little bit more sophisticated and fulsome than your initial expectations, which was going to help you sort of inform that go, no-go decision. So just curious as to where we are in terms of that process? Is year-end still the right benchmark on time lines there? And have the post evolved a little bit in your mind in light of the ESMO data on advanced adenoma from one of your peers?

好的。這實際上非常有幫助。史蒂夫，是我放映的最後一位。我們已經收到了一些問題。早在九月份，您就談到了相對接近共享這些數據。我想你也會指出，你期望最初的概念驗證比你最初的期望更加複雜和豐富，這將有助於你做出是否繼續的決定。只是好奇我們在這個過程中處於什麼位置？年底仍然是時間線的正確基準嗎？鑑於您的一位同行關於晚期腺瘤的 ESMO 數據，您對這篇文章的看法是否有所改變？

Yeah, it's a good question. So yes, we plan on actually reading that out as we said, I would say, very early in 2025, there's a couple of big investor conferences and medical conferences where we're going to be reading out the initial early cancer detection screening data in CRC and just stay tuned. We're very close now.

是的，這是一個好問題。所以，是的，我們計劃實際宣讀，正如我們所說，我想說，在 2025 年初，我們將在一些大型投資者會議和醫學會議上宣讀最初的早期癌症檢測篩檢數據。我們現在非常接近了。

Rachel Vatnsdal, JP Morgan.

雷切爾·瓦特斯達爾，摩根大通。

Hey, great, good afternoon and congratulations on the quarter. You guys. So first I have just on Signatera volume. Can you walk us through what you guys are assuming within 4Q for quarter-over-quarter Signatera volume growth? You've historically talked about this 8,000 to 10,000 rate for the past few quarters. You've obviously been beating that as well. So should we expect that trend of beating that volume level into 4Q to continue? And then what kind of a sequential assumption when we head into 2025?

嘿，太好了，下午好，恭喜這個季度。你們。首先我先講 Signatera 卷。您能否向我們介紹一下你們對第四季 Signatera 銷售季比成長的假設？在過去的幾個季度裡，您一直在談論這個 8,000 到 10,000 的比率。顯然你也已經打敗它了。那麼，我們是否應該預期第四季銷售水準會突破這一趨勢的趨勢會持續下去？那麼當我們進入 2025 年時，會採取什麼樣的連續假設呢？

Yeah. So I think as we -- well, first on Q3, I mean, obviously, this was like a really strong quarter. I think we did 11,400 sequentially. That was, I think, the third fastest we've ever had well above this average of 8,000 to 10,000. We said all along that you just really can't kind of get into the kind of quarter-over-quarter sequential comparisons just because there's differences in sort of the number of holidays, the differences in the number of receiving days, and you can just -- I mean 1 day could be 2,000 additional samples, right, that you weren't able to access because maybe it was a Sunday or maybe it was a holiday or something like that.

是的。所以我認為，首先是第三季度，我的意思是，顯然，這是一個非常強勁的季度。我想我們連續做了 11,400 個。我認為這是我們有史以來第三快的速度，遠高於 8,000 到 10,000 的平均水平。我們一直說，你真的不能僅僅因為假期數量、接收天數的差異而進行季度環比的連續比較，你可以-- 我的意思是1 天可能有2,000 個額外的樣本，對吧，您無法訪問這些樣本，因為可能是星期日，也可能是假期或類似的情況。

So we're just sort of sticking with that conservative estimate of saying, look, 8,000 to 10,000 is sort of the average, that's kind of roughly what we've plugged in. But of course, we're always trying to beat that and either for outperformance or for just kind of the way the days fell and so forth. We've been able to come above that in the last several quarters.

所以我們只是堅持保守的估計，看，8,000 到 10,000 是平均值，這就是我們插入的大致內容。但當然，我們一直在努力超越這一點，要么是為了出色的表現，要么是為了日子的流逝等等。在過去的幾個季度中，我們已經超越了這個目標。

I think on the Q4 number in particular, we don't really have enough Q4s in our in our bag to tell you exactly like what the seasonality is with this product just yet? And to Steve's point, I mean, like obviously, in Q4, you're going have more holidays. Last Q4, we ended up having a strong number, but like Christmas and New Year's landed on opposing weekends that made it very -- we take that whole week off.

我認為特別是在第四季的數字上，我們包包裡還沒有足夠的第四季來準確地告訴您該產品的季節性是什麼？對於史蒂夫的觀點，我的意思是，顯然，在第四季度，你將有更多的假期。上個季度，我們的業績表現強勁，但就像聖誕節和新年正好在相反的周末一樣，這使得我們整個星期都休息。

So we ended up, I think, in retrospect, got a lot of units kind of the first two weeks in January that would have normally landed in December. So hence, the caution around trying to land a specific number for a quarter here. But taking a little bit more caution around Q4 just because there are a lot of holidays.

所以，我認為，回想起來，我們最終在一月的前兩週獲得了很多通常會在 12 月落地的單位。因此，在嘗試確定季度的具體數字時要謹慎。但第四季前後要更加謹慎，因為假期很多。

Yeah. But, but I think also as we, we said in the prepared remarks, I mean, we, you know, despite I think this hurricane hit in the beginning of the October, we, you know, we're off to a fast start Q4.

是的。但是，但我認為，正如我們在準備好的發言中所說，我的意思是，我們，你知道，儘管我認為這場颶風是在十月初襲擊的，但我們，你知道，我們正在快速啟動Q4。

Got it. And then by just on SG&A. You raised the guide for SG&A for the year. And you've talked about accelerating some of your growth investments. So obviously, it makes sense to invest into the business. But just can you break down for us where is that driving increased spend going towards?

知道了。然後只考慮SG&A。您提出了本年度的 SG&A 指南。您也談到了加速一些成長投資。顯然，投資這項業務是有意義的。但您能否為我們分析一下，支出增加的動力在哪裡？

And then on 2025, you've historically talked about this like annual OpEx growth of mid-single digits to high single digits over time. So is that the right way for us to think about 2025? Or what other factors should we be considering that would move the number higher or lower relative to that range?

然後到 2025 年，您歷史上曾談論過這個問題，例如隨著時間的推移，每年的營運支出成長從中個位數到高個位數。那麼，這是我們思考 2025 年的正確方式嗎？或者我們還應該考慮哪些其他因素會使數字相對於該範圍更高或更低？

Yeah. Let me comment on just kind of where we're investing. And then maybe, Mike, you can comment on sort of what it looks like in '25. Look, we've -- there's obviously a lot areas of investment and expanding clinical trials, investing heavily into innovation, user experience, customer service, new patient portals, EMR connectivity, expanding, I think, certain areas of marketing, certain areas where it makes sense to add a handful of salespeople here or there, maybe more significant expansions.

是的。讓我評論一下我們正在投資的領域。麥克，也許你可以評論一下 25 年的情況。看，我們顯然有很多領域的投資和擴大的臨床試驗，大力投資於創新、用戶體驗、客戶服務、新的患者門戶、EMR 連接，我認為，擴大了某些營銷領域，某些領域在這裡或那裡增加一些銷售人員是有意義的，也許是更重要的擴張。

So we're doing all those things. And like we said, we're in the very early stages of this opportunity. And we plan on investing in order to be able to serve as many patients as possible with our tests, and we're making those investments.

所以我們正在做所有這些事情。正如我們所說，我們正處於這個機會的早期階段。我們計劃進行投資，以便能夠透過我們的測試為盡可能多的患者提供服務，我們正在進行這些投資。

Mike, do you want to talk about '25?

麥克，你想談談'25嗎？

No, I think that's still the right kind of framework going to '25. We mentioned in the prepared remarks. I mean we're going to -- we don't really have an appetite to come back to you guys and say, we're going to burn some good amount of cash next year, and we understand that we need to be on the plus side of the ledger in terms of cash. But beyond that, our focus are -- really our primary focus really does remain on serving our patients and continuing to grow the opportunity.

不，我認為到 25 世紀這仍然是正確的框架。我們在準備好的發言中提到過。我的意思是，我們真的沒有興趣回到你們身邊並說，明年我們將燒掉大量現金，而且我們知道我們需要繼續努力就現金而言，賬本的正數。但除此之外，我們的重點仍然是為患者提供服務並繼續增加機會。

Douglas Schenkel, Wolfe Research.

道格拉斯‧申克爾，沃爾夫研究中心。

Okay. First, on volume growth. You're tracking the year-on-year volume growth of, I think, about $550,000, maybe $600,000.

好的。首先，關於數量增長。我認為，您追蹤的同比銷量增長約為 550,000 美元，也許是 600,000 美元。

Mike, if I heard you right, I think you said at some point on the call, we should expect similar volume growth next year. Did I get that right? And if so, does that mean a similar number of incremental tests across the portfolio next year?

麥克，如果我沒聽錯的話，我想你在電話會議上的某個時刻說過，我們應該預期明年會有類似的銷售成長。我做對了嗎？如果是這樣，這是否意味著明年整個產品組合將進行類似數量的增量測試？

Yeah. I mean, I think that's always kind of our baseline to try and do that as a growth goal, is to focus on this, quantify this as absolute units rather than growth rates. I think the growth rates become challenging because the base business becomes so much bigger. So that's going to be the goal. Similar comments as what Steve gave previously though, as it relates to the different drivers and the puts and takes.

是的。我的意思是，我認為這始終是我們嘗試將其作為成長目標的基線，重點關注這一點，將其量化為絕對單位而不是成長率。我認為成長率變得具有挑戰性，因為基礎業務變得如此之大。這將是我們的目標。不過，與史蒂夫之前給出的評論類似，因為它涉及不同的驅動因素以及看跌期權和拿單。

Okay. Year-to-date, you have about $110 million in true-ups. Hopefully, I did that math right. Obviously, we don't know what Q4 true-ups are going to be. That said, as we model out of next year, should we be kind of taken true-ups out of the base as we think about normalizing the business space? Or is there an argument that these true-ups are actually indicative of better collections and sustainable ASP improvements?

好的。今年迄今為止，您的真實投資金額約為 1.1 億美元。希望我的數學計算正確。顯然，我們不知道第四季的調整會是什麼。也就是說，當我們為明年做模型時，當我們考慮業務空間正常化時，我們是否應該從基礎中採取一些調整措施？或者是否有觀點認為，這些真實情況實際上表明了更好的收藏和可持續的平均售價改進？

Well, I think it's both. I mean the reality is that the collections have come in ahead of our expectations as defined by our accruals from last year. And so that's -- what kind of driving true-ups, which should happen when the ASPs are going up this much. But the ASP is going up a lot is an attempt to kind of respond to that and just kind of match the revenue as best we can based on the information we have available to us at the time when we put to queue.

嗯，我認為兩者都是。我的意思是，現實情況是，這些系列的表現超出了我們去年應計費用所定義的預期。這就是——當平均售價上漲這麼多時，應該會發生什麼樣的推動調整。但平均售價的大幅上漲是一種嘗試，旨在對此作出回應，並根據我們排隊時掌握的信息，盡可能地匹配收入。

So it's our kind of expectation that we're going to continue to see true-ups moderate. And as we kind of go into next year with the guide, I still think it's appropriate to guide about the true ups because it's just impossible to kind of model the timing of when you get cash for a bunch of units that you're on the second appeal for and that you finally get the cash in, that's no way to guide kind of an operational business.

因此，我們期望我們將繼續看到溫和的真實情況。當我們進入明年的指南時，我仍然認為對真實的上漲進行指導是合適的，因為不可能對你在其中的一堆單位獲得現金的時間進行建模。現金，這無法指導營運業務。

Yeah. And Mike, I'm with you. And again, for whatever my opinion is worth like everything you just said makes sense. What I'm getting at is you've had these consistent true-ups, presumably from periods that aren't years ago, they're presumably closer and closer to the quarter we're in.

是的。麥克，我和你在一起。再說一次，無論我的意見有價值，你剛才所說的一切都是有道理的。我的意思是，你已經得到了這些一致的真實數據，大概是從幾年前的時期開始的，它們可能越來越接近我們所處的季度。

So it's almost as if like these true-ups are actually indicative of, obviously, their collections from past periods, but you're actually getting paid more frequently on these tests. So I wouldn't expect you to model -- our guide true-ups into the model. But I could see this being a sign that like, yes, the ASPs are actually going higher, and this is sustainable. Is that logical?

因此，這些真實的結果幾乎就好像實際上表明了他們過去時期的收藏，但實際上你在這些測試中獲得的報酬更加頻繁。所以我不希望你建模——我們的指導正確地進入模型。但我可以看到這是一個跡象，是的，平均售價實際上正在走高，而且這是可持續的。這符合邏輯嗎？

Yeah, definitely. I mean, I think that the fact that for those of you who've followed the -- follows for a long time know that we typically have some pretty comes commentary about which way ASPs are going when we guide, we guide to some erosion.

是的，絕對是。我的意思是，我認為，對於那些長期關注這一趨勢的人來說，我們通常會對 ASP 的走向做出一些漂亮的評論，當我們引導時，我們會引導一些侵蝕。

And that's what we're seeing, I think, gives us some confidence that we can -- women's health that we can we can be in the zone where we are now. And then there are some specific drivers to the Signatera ASP that we think are ahead of us, right? So Medicare advantage and potentially state biomarker bills.

我認為，這就是我們所看到的，這給了我們一些信心，我們可以——女性健康，我們可以，我們可以達到現在的水平。然後，我們認為 Signatera ASP 有一些特定的驅動程序，對嗎？因此，醫療保險的優勢和潛在的國家生物標誌物帳單。

So I do think your -- the improvement in the kind of the collections and the reduction of the DSOs, I mean, I think that where that gets reflected is, one, in the ASPs actually are getting higher in terms of like what we're reporting every quarter. And also that's getting reflected in our confidence in terms of what we can do over the longer term. With the remaining that you will have ups and downs with ASPs and Diagnostics business, it's just the way it goes, but we feel that we're in a good spot there.

所以我確實認為，館藏類型的改進和 DSO 的減少，我的意思是，我認為反映這一點的是，第一，ASP 實際上正在變得更高，就像我們的情況一樣。 。這也反映在我們對長期工作的信心上。剩下的 ASP 和診斷業務將會有起伏，這就是它的發展方式，但我們覺得我們處於一個很好的位置。

Okay. Last one, Mike, what was the mix of first-time tests versus recurrence monitoring. I think Dan may have tried to get at that earlier, but I'm just curious if you could give us anything specific there because it was a really good gross margin quarter. Obviously, as that mix shift starts to kind of kick in, that's another leg to gross margin, but I didn't hear anything on the call to suggest that, that was like a material driver in this period to the margin improvement.

好的。最後一個，麥克，首次測試與重複監測的組合是什麼。我認為丹可能已經嘗試更早地了解這一點，但我只是好奇您是否能給我們任何具體信息，因為這是一個非常好的毛利率季度。顯然，隨著這種混合轉變開始發揮作用，這是毛利率的另一條腿，但我在電話會議上沒有聽到任何暗示，這就像這段時期利潤率改善的物質驅動因素。

Yeah. And just one tweak there rather than like first-time patients, I think there's a -- what we typically talk about is a split between patients that are in their adjuvant treatment window, like volume in the adjuvant treatment window, we're going to reimburse on the bundle, for example, and then patients who are getting a recurrent monitoring tests.

是的。只是一個調整，而不是像首次接受治療的患者那樣，我認為我們通常談論的是處於輔助治療窗口的患者之間的劃分，例如輔助治療窗口中的容量，我們將例如，對捆綁包進行報銷，然後對接受定期監測測試的患者進行報銷。

That trend has continue to be pretty balanced between the two. And what's happening there is that you have very healthy retention of patients that have stayed with us and continue to get Signatera through their journey as they go into remission. And then we continue to fill this top of the funnel.

兩者之間的趨勢仍然相當平衡。那裡發生的情況是，您對留在我們這裡的患者保持了非常健康的保留，並在他們進入緩解期時繼續讓 Signatera 度過他們的旅程。然後我們繼續填充漏斗的頂部。

We continue to get new patients in the door. And so that has continued to increase our patients here in the adjuvant treatment window. And the net of all that is that we've been pretty balanced between adjuvant window, petitions and recurrence monitoring so far. So that by itself is not kind of -- there's not some huge move in that trend just in this quarter. The bigger move though is kind of just the mix of the different franchises in terms of contribution to total revenue and the implications that has for ported gross margins, as I described to them.

我們不斷迎來新患者。因此，我們的患者在輔助治療窗口中的數量不斷增加。最重要的是，到目前為止，我們在輔助窗口、請願和復發監測之間已經相當平衡。因此，就其本身而言，這一趨勢在本季並沒有出現重大變化。正如我向他們描述的那樣，更大的舉措是不同特許經營權對總收入的貢獻以及對移植毛利率的影響的混合。

Matt Sykes, Goldman Sachs.

馬特·賽克斯，高盛。

Hey, good afternoon. Thanks for my questions and congrats on the quarter. Mike, maybe just the first one for you. Just following up on Rachel's question on the OpEx. I'm just curious, as you think about the women's health business, certainly as it relates to sales and marketing. Are we at kind of a steady state there on the sales and marketing side, where there's sort of some maintenance investment you think you made, but most of the sales and marketing is going towards Signatera.

嘿，下午好。感謝我的問題並祝賀本季。麥克，也許只是你的第一個。只要跟進 Rachel 關於營運支出的問題。我只是很好奇，當你想到女性健康業務時，當然是因為它與銷售和行銷有關。我們在銷售和行銷方面是否處於穩定狀態，您認為自己進行了一些維護投資，但大部分銷售和行銷都流向了 Signatera。

I'm just trying to think about as we move into '25, how you're thinking about the allocation of OpEx across the product portfolio? And just want to make sure that my assumption on the Signatera is the sort of the beneficiary spend are going to be maintained into next year?

我只是想想想，當我們進入 25 世紀時，您如何考慮 OpEx 在整個產品組合中的分配？只是想確保我對 Signatera 的假設是受益人支出將維持到明年嗎？

Steve, do you have a take on that or you want me to go?

史蒂夫，你對此有什麼看法還是想讓我離開嗎？

Yeah. I'll comment and then you have extra. But yeah, I would say that's about right. I mean, look, there's, you know, we already, you know, have, I think, you know, pretty big presence from a commercial standpoint of women's health and we built that over the last, you know, 12 years or so.

是的。我會發表評論，然後你還有額外的。但是，是的，我想說這是正確的。我的意思是，看，你知道，我們已經，你知道，從女性健康的商業角度來看，我們已經擁有相當大的影響力，你知道，我們在過去12 年左右的時間裡建立了這一點。

You know, obviously we're sometimes able to kind of add in additional medical science liaisons or genetic counselors. Medical directors, maybe, you know, do some new clinical trials and do innovative things like we did with the (inaudible) test that we, you know, what was a very timely launch and able to help you know, a lot of patients, you know, but largely.

你知道，顯然我們有時可以增加額外的醫學聯絡員或遺傳諮詢師。醫療主任，也許，你知道，做一些新的臨床試驗，做一些創新的事情，就像我們所做的（聽不清楚）測試，我們，你知道，這是一個非常及時的啟動，能夠幫助你知道，很多患者，你知道，但很大程度上。

Yeah, we're focusing on, I think helping oncology patients and, you know, we see that, you know, Signatera is really making an impact on care and we're seeing that it's at the very early stages and that's where a lot of the spending is going. Both, you know, when you look at additional clinical trials, you look at research and development, you look at innovation, you look at the sort of we already do have a big, you know, commercial presence there, but you look at sort of rounding that out. You know, that's where a lot of the spending is going.

是的，我們的重點是，我認為幫助腫瘤患者，我們看到，Signatera 確實對護理產生了影響，我們看到它還處於非常早期的階段，這就是許多的地方的支出正在發生。兩者，你知道，當你看額外的臨床試驗時，你看研究和開發，你看創新，你看我們已經在那裡有一個很大的商業存在，但你看排序將其四捨五入。你知道，這就是大量支出的去向。

Got it. And then just for my follow-up, just on Signatera. Have there been any noticeable differences in indication growth. Meaning, I know it CRC and breast is sort of the main ones, but have you seen any shift towards different indications that any that are ramping up significantly that might have been sort of lower volumes to begin with? Or has it been pretty consistent this whole time?

知道了。然後是我的後續行動，就在 Signatera 上。適應症生長是否有任何明顯差異。意思是，我知道結直腸癌和乳腺癌是主要的，但是您是否看到任何向不同跡象的轉變，即任何跡象表明任何開始時可能數量較低的顯著增加？還是一直以來都非常一致？

Yeah. I think it's been pretty consistent, but certainly, what drives utilization broadly is peer-reviewed evidence. And where we're able to generate data, which we've done a lot of. I think we now have more than 85 publications supporting the use of the Signatera technology where we're able to generate data, that tends to be kind of where you see physicians using the product. And that makes sense, right? You want to have the evidence-based decision-making.

是的。我認為這是相當一致的，但當然，廣泛推動利用率的是同儕審查的證據。我們能夠產生數據，我們已經做了很多工作。我認為我們現在有超過 85 篇出版物支持使用 Signatera 技術，我們能夠在其中產生數據，這往往是您看到醫生使用該產品的地方。這是有道理的，對吧？您希望做出基於證據的決策。

So some of the areas that we talked about, muscle invasive bladder, we're excited about that with IMvigor010 being, I think, a very strong study itself and now with the IMvigor011 data reading out in 2025, as Alex mentioned, I think that's a great opportunity. Of course, IO monitoring is another area where we do see quite a bit of utilization we generated some good data there. So yes, it's a mix. It's one of the reasons why I think there's still some

因此，我們討論的一些領域，肌肉侵入性膀胱，我們對此感到興奮，我認為IMvigor010 本身就是一項非常強大的研究，現在隨著IMvigor011 數據在2025 年讀出，正如Alex 提到的，我認為這是一個很好的機會。當然，IO 監控是另一個領域，我們確實看到了相當多的利用率，我們在那裡產生了一些好的數據。所以是的，這是一個混合體。這就是我認為仍然有一些的原因之一

upside opportunity from getting coverage even from Medicare on additional indications is that we do have a decent chunk of utilization that's outside of the currently covered indications.

即使從醫療保險中獲得額外適應症的承保的上行機會是，我們確實有相當多的利用率超出了目前承保的適應症。

Tycho Peterson, Jefferies.

第谷·彼得森，杰弗里斯。

Hey, thanks. A lot has been asked already. Just a couple on the numbers here in the near term. What was the Invitae contribution in the quarter? And then you did raise by more than the beat, $40 million by more than the beat, what's the delta on that?

嘿，謝謝。已經問了很多了。這裡僅介紹一些近期的數字。Invitae 本季的貢獻是多少？然後你確實籌集了超過節拍的資金，超過節拍的 4000 萬美元，那麼增量是多少？

Yeah. The delta is really just the -- just continued growth kind of across the book is what we've seen. I would also encourage you to back up the true-ups as well. But nonetheless, even back at the true-up. So we increased the guidance more than -- substantially more than the beat, and that's just kind of all the comments we've made on the call so far in terms of kind of where the business is.

是的。三角洲實際上只是我們所看到的整本書中的持續增長。我也鼓勵您也支持真實的情況。但儘管如此，即使回到真實狀態。因此，我們增加的指導遠遠超過了節拍，這只是我們迄今為止在電話會議上就業務狀況發表的所有評論。

Invitae contribution, you haven't broken up specifically other than to say, like I think the beginning of the year, we added a $25 million contributor to the guide, and we kind of move that to $40 million, and it's been in that zone in terms of full year contribution, and that's where we have it for the guide for the year.

Invitae 貢獻，除了說，就像我認為今年年初，我們為指南增加了 2500 萬美元的貢獻者，我們將其增加到 4000 萬美元，而且它一直在這個區域就全年貢獻而言，這就是我們今年的指南。

And then I guess thinking about the framework you've put in place for next year, the 500,000 to 600,000 tests, where do you think kind of the community penetration goes? And then it sounds like you don't feel like you need to add additional reps at this point as we think about next year?

然後我想考慮您明年制定的框架，即 500,000 到 600,000 次測試，您認為社區滲透率會走向何方？然後，聽起來您不覺得在我們考慮明年的時候需要增加額外的代表？

Yeah. I'll just comment on penetration. I mean, look, obviously, it's slightly different by tumor type and then whether you're talking about sort of the adjuvant setting or new incident patients or the prevalent pool of patients. But looking broadly at the bigger opportunity, I mean, we still think we're in the low single digits. So there's a ton of opportunity ahead in community and academic settings. And we are adding sales team members in additional to medical team members and doing more clinical trials, which is a big part of our investment.

是的。我只評論一下滲透率。我的意思是，顯然，腫瘤類型略有不同，無論你談論的是輔助治療還是新發生的患者還是普遍的患者群體。但從更廣泛的角度來看更大的機會，我的意思是，我們仍然認為我們處於較低的個位數。因此，社區和學術環境中存在大量機會。除了醫療團隊成員之外，我們還增加了銷售團隊成員，並進行了更多的臨床試驗，這是我們投資的很大一部分。

Okay. And then just lastly, I guess, on time lines for the readouts on breast and kidney, should we still expect those next year as well? I mean, I know we've covered CRC and bladder and some of the other indications, but how do we think about the breast and kidney time lines?

好的。最後，我想，關於乳房和腎臟讀數的時間表，我們是否還應該期待明年的結果？我的意思是，我知道我們已經討論了 CRC 和膀胱以及其他一些適應症，但我們如何看待乳房和腎臟的時間線？

Yeah. We've got, I think, a very solid road map of data that's going to be reading out. So not just across those indications, but I think a broad sort of span of indications. We've got pretty big data sets reading out, which we're excited about. So I think right now, there's probably over 100 trials that are underway that are going to be reading out the various time points. So we're excited about that. We're excited about generating evidence that can drive additional coverage from medicare and that can drive additional utilization.

是的。我認為，我們已經有了一個非常可靠的數據路線圖，可以讀出。因此，不僅涵蓋這些適應症，而且我認為涵蓋了廣泛的適應症。我們已經讀取了相當大的資料集，對此我們感到很興奮。所以我認為現在可能有超過 100 項試驗正在進行中，這些試驗將讀出不同的時間點。所以我們對此感到興奮。我們很高興能夠提供證據，這些證據可以推動醫療保險的額外覆蓋，並可以推動更多的利用率。

This will conclude our Q&A session and with that, we will conclude today's conference call. Thank you all for your participation. You may now disconnect.

我們的問答環節到此結束，今天的電話會議也將結束。感謝大家的參與。您現在可以斷開連線。