Natera Inc (NTRA) 2024 Q2 法說會逐字稿

Good afternoon and welcome to Natera Inc.'s Q2 earnings conference call. (Operator Instructions) As a reminder, this conference call is being recorded. I would now like to turn the call over to Mike Brophy, Chief Financial Officer. Thank you. Please go ahead.

下午好，歡迎參加Natera公司第二季財報電話會議。（操作員說明）提醒各位，本次電話會議正在錄音。現在我將把電話交給財務長麥克‧布羅菲。謝謝。請繼續。

Thanks, operator. Thanks, operator, and good afternoon. Thank you for joining our conference call to discuss the results of our second quarter of 2024. On the line, I'm joined by Steve Chapman, our CEO; Solomon Moshkevich, President, Clinical Diagnostics; and Alex Aleshin, General Manager of Oncology and Chief Medical Officer.

謝謝接線生。謝謝接線員，下午好。感謝您參加我們的電話會議，討論我們 2024 年第二季的業績。連線嘉賓有：我們的執行長 Steve Chapman；臨床診斷總裁 Solomon Moshkevich；以及腫瘤科總經理兼首席醫療官 Alex Aleshin。

Today's conference call is being broadcast live via webcast. We will be referring 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。電話會議的錄音回放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 or assumptions to 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做出前瞻性陳述，例如我們的營運和財務展望及對展望的預測或假設、市場規模、合作夥伴關係、臨床研究及預期結果、機會和策略，以及對各種現有和未來產品的預期，包括產品功能、預期發布日期、報銷範圍以及我們對我們財務業績相關因素的影響。

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 contained in or suggested by the forward-looking statements. Forward-looking statements made during the call are being made as of today, August 8, 2024. 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.

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（2024 年 8 月 8 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公司聲明不承擔更新或修改任何前瞻性聲明的義務。

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

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。現在我想把電話交給史蒂夫。史蒂夫？

Great. Thanks, Mike. Let's get to the highlights in the next slide. We had another excellent quarter across the board. Revenues were up 12% sequentially versus Q1 of 2024 at up 58% compared to Q2 of last year. This was driven by record volumes and another strong quarter to ASP growth. Volumes were up over 23% compared to Q2 of last year.

偉大的。謝謝你，麥克。讓我們在下一張投影片中重點介紹一下。我們又迎來了一個全面優異的季度。與 2024 年第一季相比，營收季增 12%；與去年第二季相比，營收成長 58%。這主要得益於創紀錄的銷售量和另一個強勁的平均售價成長。與去年第二季相比，銷量成長超過 23%。

We had a great quarter winning new accounts in women's health, and despite the typical Q2 seasonal headwinds, we grew volume sequentially versus Q1. In organ health, we posted another strong volume quarter. And in oncology, Signatera grew another roughly 13,000 clinical units over what was a very strong Q1.

我們在女性健康領域贏得了大量新客戶，度過了一個非常棒的季度。儘管第二季面臨典型的季節性不利因素，但我們的銷售量仍比第一季環比成長。在器官健康領域，我們迎來了一個強勁的季度銷售成長。在腫瘤領域，Signatera 在第一季又增加了約 13,000 個臨床單位，表現非常強勁。

We delivered a strong gross margin quarter with actually ASP at cost trends that I'll get into shortly. All of that means we can raise our guidance in revenues and gross margin for the full year. We are now centering the guide around roughly $1.5 billion in revenue and a 55% gross margin.

我們實現了強勁的毛利率季度，實際平均售價與成本趨勢相符，我稍後會詳細介紹。這意味著我們可以提高全年營收和毛利率的預期。我們現在將本指南的重點放在約 15 億美元的收入和 55% 的毛利率上。

At the midpoint, the new guide implies annual revenue growth of nearly 40% and an increase in gross margins of roughly 10 percentage points from the 45% gross margin we posted last year. We're excited about our progress and our transformational year continues.

根據新的指導方針，中點意味著年收入成長近 40%，毛利率比去年公佈的 45% 毛利率提高約 10 個百分點。我們對我們的進展感到興奮，我們變革性的一年仍在繼續。

We also had many positive developments are the critical and that was discussed that we'd discuss on today's call. First, I want to flag that the Altera investigators let us know that they're not going to make the timeline for the submission to ESMO in mid-September.

我們也取得了一些積極的進展，這些進展至關重要，我們將在今天的電話會議上討論這些進展。首先，我想指出，Altera 的研究人員告知我們，他們無法按時在 9 月中旬向 ESMO 提交報告。

As you know, there's a huge amount of patient reviewing data analysis to generate the results and ready them for presentation and the CIRCULATE investigator team needs more time to get everything done. Their current plan is to target ASCO GI in January so we'll stand by and let them do their work.

如您所知，我們需要對大量患者資料進行審查分析，以產生結果並準備好進行展示，而 CIRCULATE 研究團隊需要更多時間來完成所有工作。他們目前的計劃是瞄準 1 月的 ASCO GI 會議，所以我們將拭目以待，讓他們完成他們的工作。

In the meantime, we have an extremely full calendar of important data readouts in colorectal and other cancers, and we'll spend time reviewing that today.

同時，我們今天將花大量時間回顧有關大腸癌和其他癌症的重要數據發布日程。

This includes the very significant 36-month readout from the GALAXY study, which we believe is of critical importance because it marks the first perspective overall survival data readout for Signatera in colorectal cancer. These results will be shared at ESMO.

這其中包括 GALAXY 研究的 36 個月讀數，我們認為這至關重要，因為它標誌著 Signatera 在結直腸癌治療中首次獲得前瞻性總生存期數據讀數。這些結果將在歐洲腫瘤內科學會（ESMO）年會上發表。

In addition, Solomon will provide an update on organ health and some recent news on Prospera and Renasight. He will discuss a major win with the new consensus paper published by the National Kidney Foundation and recommends genetic testing for the majority of patients with kidney disease.

此外，Solomon 還將介紹器官健康的最新情況，以及 Prospera 和 Renasight 的一些最新消息。他將討論國家腎臟基金會發布的新共識文件帶來的重大勝利，該文件建議對大多數腎臟病患者進行基因檢測。

We're also launching new differentiated feature for our Prospera heart test that enhances the detection of organ rejection for heart transplant patients and allows us to deliver a more accurate risk assessment across both acute cellular rejection in antibody-mediated rejection and with donor-derived cell-free DNA percentage alone.

我們還為 Prospera 心臟檢測推出了一項新的差異化功能，該功能增強了對心臟移植患者器官排斥的檢測，並使我們能夠更準確地評估抗體介導的排斥反應中的急性細胞排斥反應以及僅使用供體來源的遊離 DNA 百分比的風險。

And finally, on the legal front, the Federal Appeals Court in July upheld a preliminary injunction of the RaDaR MRD assay made by NeoGenomics. As a reminder, the preliminary injunction was first issued by the district court late last year so this recent decision upholds that order more in sales of the assay with limited exceptions. We are pleased with the outcome and look forward to presenting our case to the jury next year.

最後，在法律方面，聯邦上訴法院於 7 月維持了對 NeoGenomics 生產的 RaDaR MRD 檢測的初步禁令。提醒一下，地方法院在去年年底首次發布了初步禁令，因此最近的這項決定在有限的例外情況下，更多地維持了該禁令在檢測產品銷售方面的效力。我們對結果感到滿意，並期待明年向陪審團陳述我們的案情。

Okay. Let's get into some of the business drivers on the next slide. The first slide shows the year-over-year volume progression we've had over time, both in terms of growth rates and absolute unit growth. This quarter looks like one of the best Q2 results we've had in the last five years. As a reminder, volumes from our existing women's health customers usually declined 2.5% to 10% compared to Q1 because currently see fewer new pregnancies in Q2.

好的。下一頁我們將探討一些業務驅動因素。第一張投影片顯示了我們多年來的年銷售成長情況，包括成長率和絕對單位成長。本季業績看起來是近五年來最好的第二季業績之一。提醒一下，由於目前第二季新懷孕人數較少，我們現有女性健康客戶的銷售量通常比第一季下降 2.5% 至 10%。

Given the large book at existing business you have in women's health, that drag of same source sales volume is hard to overcome with new account wins. So I was particularly pleased to see the new volume growth in women's health above and beyond our strong quarter in Q1.

鑑於您在女性健康領域擁有龐大的現有業務，這種來自同一來源的銷售額拖累很難透過贏得新客戶來克服。因此，我特別高興地看到，女性健康領域的新銷售成長超過了我們第一季強勁的業績。

The outperformance was partly enabled by our differentiated new product features, especially the non-invasive fetal RhD analysis, which we launched in May, in the midst of a nationwide shortage of program that continues to affect the industry today. We continue to be very showing interest in our core women's health products, Panorama, where we're the market leader in NIPT, and Horizon, where we're the market leader expanded carrier screening.

績效優異的部分原因在於我們差異化的新產品特性，特別是我們在 5 月推出的非侵入性胎兒 RhD 分析，當時全國範圍內的 RhD 分析項目短缺，而這種情況至今仍在影響著整個行業。我們對我們的核心女性健康產品 Panorama 和 Horizo​​n 仍然表現出濃厚的興趣。在 Panorama 領域，我們是 NIPT 市場的領導者；在 Horizo​​n 領域，我們是擴展型攜帶者篩檢市場的領導者。

In addition to that organic growth, we got a full quarter of contribution from the Invitae deal that we announced in January, which further boosted our growth in the quarter. We also saw another great quarter for both Prospera and Renasight. We continue to perform well here and growth is accelerating.

除了上述內生成長外，我們在 1 月宣布的 Invitae 交易也為我們帶來了整整一個季​​度的貢獻，進一步推動了我們本季的成長。Prospera 和 Renasight 的季度業績也都表現出色。我們在這裡持續表現出色，成長速度正在加快。

Of course, Signatera was a major source of growth in the quarter and we had another outstanding result in clinical volumes, as you can see on the next slide. The left-hand chart is the total oncology volume metric we've always shown, which include Signatera clinical as well as Altera orders and Empower clinical trial units.

當然，Signatera 是本季成長的主要來源，我們在臨床銷售方面也取得了另一個傑出的成績，正如您在下一張幻燈片中看到的那樣。左側圖表是我們一直在展示的腫瘤總量指標，其中包括 Signatera 臨床訂單、Altera 訂單和 Empower 臨床試驗單元。

The right-hand chart shows the quarterly volume progression of the clinical setting over time. You can see in the past, we typically have added about 8,000 or 9,000 units per quarter. We had a big step-up in Q1, and now we followed that with roughly 13,000 sequential units in Q2.

右側圖表顯示了臨床環境的季度業務量隨時間的變化。從以往的數據可以看出，我們通常每季新增約 8,000 或 9,000 台設備。我們在第一季取得了巨大的進步，現在我們在第二季度又連續增加了約 13,000 台設備。

While we still think roughly 8,000 to 10,000 units of quarterly growth is the right baseline expectation going forward, clearly, the experienced physicians and patients are having with Signatera continues to drive meaningful adoption.

雖然我們仍然認為每季度增長約 8,000 至 10,000 台是未來合理的基準預期，但顯然，經驗豐富的醫生和患者在使用 Signatera 後，持續推動著產品的顯著普及。

So all that volume growth helped us one of the best Q2 revenue growth performances in recent memory. This next slide shows the Q1 to Q2 change in revenue in the last two years alongside the 2024 results. In addition to volume trends, we continue to see very positive trends in ASPs really across the businesses.

因此，銷售成長幫助我們實現了近年來最佳的第二季營收成長業績之一。下一張投影片顯示了過去兩年第一季到第二季的收入變化以及 2024 年的業績。除了銷售趨勢之外，我們也看到各業務的平均售價也持續呈現非常正面的趨勢。

Signatera ASPs were up modestly over Q1 when we're modeling some additional growth ASPs for the rest of the year as we've seen some continued positive momentum from both Medicare Advantage plans and biomarker state reimbursement that can be a source of upside through the year.

Signatera 的平均售價較第一季略有上漲，我們預計今年剩餘時間的平均售價將進一步增長，因為我們看到 Medicare Advantage 計劃和生物標誌物州報銷方面持續保持積極勢頭，這可能成為全年上漲的來源。

Women's health ASPs were very strong once again this quarter, even without the tailwind of potential new guidelines, which we're still very positive on, we continue to make improvements on the fraction of cases that are getting reimbursed. That has been a major undertaking internally and we made substantial investments in data analysis, engineering, and persistent appeals to payer outreach to make that happen.

即使沒有潛在的新指南帶來的利多（我們仍然對此非常樂觀），本季女性健康平均銷售價格 (ASP) 依然非常強勁，我們在獲得報銷的病例比例方面繼續取得進步。這在公司內部是一項重大工程，我們投入了大量資金用於數據分析、工程和持續不斷地向支付方發出呼籲，才得以實現這一目標。

We model women's health ASPs remaining stable through the rest of the year, but we have a list of projects that may provide upside as we work through them. All of this effort is driving cash collections in excess of the revenue accruals we set last year, which is why we are seeing these revenue true-ups in 2024. These true-ups will be lumpy and so we don't include future true-ups in our guidance, but they do represent execution above our prior expectations.

我們預計女性健康領域的平均銷售價格將在今年剩餘時間內保持穩定，但我們有一些項目可能會在我們推進這些項目的過程中帶來成長。所有這些努力都促使現金回收超過了我們去年設定的收入預期，這就是為什麼我們在 2024 年看到了這些收入調整。這些調整幅度會比較大，因此我們不會在業績指引中納入未來的調整，但它們確實代表了業績執行超出了我們先前的預期。

While the ASPs improve, we continue to benefit from the efforts of our R&D team to reduce our cost of goods sold. Signatera COGS modestly declined again in the quarter and are now just above $400 and our women's health COGS remained in the range we achieved in prior quarters.

在平均售價提高的同時，我們繼續受益於研發團隊為降低銷售成本所做的努力。Signatera 的銷售成本在本季再次小幅下降，目前略高於 400 美元，而我們的女性健康銷售成本則保持在前幾季所達到的範圍內。

The net result is that we had a record gross margin quarter. This slide shows both the total gross margins as well as the underlying gross margins net revenue true-ups and both metrics tell the same story. Underlying organic gross margins grew about 2 full percentage points above the Q1 results and now stand above 54%.

最終結果是我們實現了創紀錄的季度毛利率。此投影片顯示了總毛利率以及毛利率淨收入調整值，這兩個指標都說明了同一個問題。基礎有機毛利率比第一季增加了約 2 個百分點，目前已超過 54%。

The next slide shows our cash burn trajectory over time. For those of you that are newer to the story, you can see that, historically, we made substantial initial investment to launch Signatera and now we are getting scale on that commercial and operational base while women's health continues to generate cash.

下一張投影片展示了我們現金消耗隨時間變化的軌跡。對於不太了解情況的人來說，你們可以看到，從歷史上看，我們投入了大量的初始資金來推出 Signatera，現在我們正在擴大商業和營運規模，同時女性健康領域也持續產生現金流。

We are very pleased to be cash flow breakeven for the second consecutive quarter, which is above our expectations, given the potential for seasonal headwinds in Q2. Looking into the second half of the year, we are well positioned to hit the guide of cash flow breakeven for the full year, even when incorporating the stepped up investment in R&D and sales we announced in May.

我們很高興連續第二季實現現金流量收支平衡，考慮到第二季可能存在的季節性不利因素，這超出了我們的預期。展望下半年，即使考慮到我們在 5 月宣布的加大研發和銷售投入，我們也有信心實現全年現金流收支平衡的目標。

I'll say this again, we did not get to cash flow breakeven by flashing investments into our future. Our strategy is to keep our foot on the gas and then make sure we're doing everything we need to deliver fantastic products for our patients.

我再說一遍，我們實現現金流收支平衡並不是靠揮霍未來資金。我們的策略是保持前進的步伐，然後確保我們盡一切努力為患者提供優質的產品。

With that, let me hand the call over to Solomon to cover organ health and commercial updates from oncology. Solomon.

接下來，我將把電話交給 Solomon，讓他介紹腫瘤領域的器官健康和商業動態。所羅門。

Thanks, Steve. Good afternoon, everyone. I'll start with updates in organ health. Since we launched the Renasight test in 2020 for renal genetics, chief trial data announced society guidelines have reinforced the importance of genetic testing for the 37 million patients in the US affected by chronic kidney disease, or CKD. We are pleased to share that the National Kidney Foundation published a new consensus paper last week with a strong endorsement for comprehensive genetic testing in the majority of patients with CKD.

謝謝你，史蒂夫。大家下午好。我先從器官健康的最新進展說起。自 2020 年我們推出用於腎臟遺傳學的 Renasight 測試以來，主要試驗數據公佈，學會指南強調了基因檢測對於美國 3700 萬慢性腎臟病 (CKD) 患者的重要性。我們很高興地宣布，美國國家腎臟基金會上週發布了一份新的共識文件，強烈支持對大多數慢性腎臟病患者進行全面的基因檢測。

The consensus paper included input from experts in nephrology, clinical and lab genetics, kidney pathology, and genetic counseling, in addition to patients who also provided their prospective. The NKF paper recommended a broad, multi-gene panel as the primary choice for testing. Natera agrees with that position and our Renasight test covers 385 genes.

該共識文件匯集了腎臟病學、臨床和實驗室遺傳學、腎臟病理學和遺傳諮詢等領域的專家意見，以及患者的意見，患者也提供了他們的觀點。NKF 的報告建議採用廣泛的多基因檢測作為主要檢測方法。Natera 也認同這個觀點，我們的 Renasight 測試涵蓋 385 個基因。

NKF also clearly recognized the clinical utility and benefits of genetic testing across a wide range of renal condition and patient characteristics. We, too, reported on that strong utility in our recent RenaCARE trial, which showed one out of five patients with a positive genetic diagnosis, one out of two positives, leading to a change in diagnosis, and one out of three positive cases, leading to a change in therapy.

NKF 也明確認識到基因檢測在各種腎臟疾病和患者特徵方面的臨床實用性和益處。我們在最近的 RenaCARE 試驗中也報告了這種強大的效用，結果顯示，五分之一的基因診斷陽性患者、兩分之一的陽性患者導致診斷改變、三分之一的陽性病例導致治療改變。

The NKF paper follows the recent guideline update from KDIGO, which we spoke about on our earnings call in May. So this means we now have support for genetic testing from two of the major organizations in nephrology. We believe these recommendations will continue to have a positive impact on clinical adoption of the Renasight test.

NKF 的這份文件遵循了 KDIGO 最近發布的指南更新，我們在 5 月的財報電話會議上討論過該指南更新。這意味著我們現在得到了腎臟科領域兩大組織對基因檢測的支持。我們相信這些建議將繼續對 Renasight 檢測的臨床應用產生正面影響。

Moving on to Prospera, where we are seeing multiple account wins and kidney, heart, and lung. Following some turbulence long after changes in Medicare reimbursement, we see the market has fully rebounded and on a positive growth trajectory. And we believe Prospera is taking a disproportionate share of the growth.

接下來是 Prospera，我們看到在那裡贏得了多個客戶，包括腎臟、心臟和肺臟。在醫療保險報銷政策改變後的很長一段時間裡，市場經歷了一些動盪，但目前已經完全反彈，並走上了積極的成長軌道。我們認為 Prospera 獲得了不成比例的成長份額。

I would like to highlight that we recently launched a product enhancement for our heart transplant test called DQS, or donor quantity score. Previously, Prospera Heart reported out the fraction of donor-derived cell-free DNA in blood compared to the total cfDNA. But the donor fraction can be influenced by fluctuations in background cell-free DNA.

我想重點介紹一下，我們最近推出了心臟移植測試的產品改進，稱為 DQS，即捐贈者數量評分。先前，Prospera Heart 報告了血液中供體來源的遊離 DNA 與總 cfDNA 的比例。但供體比例可能會受到背景無細胞 DNA 波動的影響。

For example, patients who are fighting off an infection, a malignancy, or who just underwent surgery, all of those could cause the background levels of cell-free DNA to vary. With DQS, we have a second threshold which is independent of those background cell-free DNA levels. This feature was previously introduced for Prospera Kidney and now it's available for Prospera Heart, too.

例如，正在與感染、惡性腫瘤作鬥爭的患者，或剛接受手術的患者，都可能導致無細胞 DNA 的背景水平發生變化。利用 DQS，我們有一個與背景無細胞 DNA 水平無關的第二個閾值。此功能之前已在 Prospera Kidney 中推出，現在也適用於 Prospera Heart。

In a study presented at the International Society for Heart and Lung Transplantation in April, we showed that the addition of DQS increased Prospera's sensitivity to rejection in heart transplant from 80% to 88%, and it also reduced false positives by approximately 37%. We plan to submit this study for peer review publication later this year. This new and improved test enables clear clinical decisions and fewer unnecessary biopsies all using dd-cfDNA.

在 4 月國際心臟和肺移植協會上發表的一項研究中，我們表明，添加 DQS 將 Prospera 對心臟移植排斥反應的敏感度從 80% 提高到 88%，並且還將假陽性率降低了約 37%。我們計劃在今年稍後將這項研究提交同行評審發表。這項全新改進的檢測方法利用 dd-cfDNA，能夠做出清晰的臨床決策，減少不必要的活檢。

Turning now to oncology. On the commercial front, as Steve noted, we saw excellent growth for Signatera clinical volumes driven by multiple factors. We saw another impressive increase in the number of ordering physicians with over 40% of all oncologists in the US ordering at least Signatera test during the quarter.

接下來我們來談談腫瘤學。在商業方面，正如史蒂夫所指出的，在多種因素的推動下，我們看到 Signatera 臨床銷售量實現了優異的成長。我們看到開立 Signatera 檢測單的醫生數量再次顯著增加，美國超過 40% 的腫瘤科醫生在本季度至少開了一次 Signatera 檢測單。

There was also strong growth in new patient initiations, which was observed across all major disease indications, led especially by colorectal cancer and breast cancer. This growth is being driven by the core value proposition of Signatera to inform risk-based treatment decisions in the adjuvant setting after surgery, to monitor for recurrence in conjunction with standard imaging, enabling earlier interventions.

新患者數量也出現了強勁增長，所有主要疾病適應症均觀察到了這一增長，其中結直腸癌和乳腺癌的病例尤其顯著。Signatera 的核心價值主張推動了這一增長，即在手術後的輔助治療中，透過提供基於風險的治療決策訊息，結合標準影像學檢查監測復發情況，從而實現更早的干預。

For example, over 85% of colorectal cancer recurrence are historically caught too late for curative intent surgery, which is the preferred treatment approach. And number three, to monitor for response to neoadjuvant therapy and immunotherapy.

例如，歷史上超過 85% 的大腸直腸癌復發病例發現時已為時過晚，無法進行根治性手術，而根治性手術是首選的治療方法。第三，監測對新輔助治療和免疫治療的反應。

We're also investing heavily in user experience. Record numbers of customers are choosing mobile phlebotomy and engaging with Natera through our digital portals and EMR integrations. And test results are being delivered reliably in under three weeks from the time of specimen receipt for initial cases and under a week for subsequent cases.

我們也在大力投資用戶體驗。越來越多的客戶選擇行動採血服務，並透過我們的數位入口網站和 EMR 整合與 Natera 互動。對於首批病例，檢測結果可在收到樣本後三週內可靠地送達；對於後續病例，檢測結果可在收到樣本後一周內可靠地送達。

One final note on the commercial side. I want to comment on our partnership with Foundation Medicine. The deal with Foundation was originally signed in 2019 and was up for renewal this summer. For business reasons, the companies have decided not to renew the agreement. This allows Natera to maintain our focus on growing Signatera, Altera, and Empower, and adding new cutting-edge products and services to our oncology portfolio. For continuity of care, we will continue monitoring services for any existing F1 tracker patients.

關於商業方面，還有最後一點要補充。我想就我們與基金會醫學的合作關係發表一些看法。與基金會的協議最初於 2019 年簽署，今年夏天到期需要續約。出於商業原因，兩家公司決定不再續約協議。這使得 Natera 能夠繼續專注於發展 Signatera、Altera 和 Empower，並為我們的腫瘤產品組合添加新的尖端產品和服務。為了確保醫療服務的連續性，我們將繼續監控所有現有 F1 追蹤患者的服務。

Now I'll turn it over to Alex to discuss clinical roadmap in oncology. Alex.

現在我將把發言權交給 Alex，讓他來討論腫瘤學的臨床路線圖。亞歷克斯。

Thanks, Solomon. Operational improvements and volume growth and oncology business continue to outperform. And the clinical utility of Signatera continues to gain traction based on the core value proposition from a previous slide.

謝謝你，所羅門。營運改善、銷售成長、腫瘤業務持續表現優異。基於前一張投影片中闡述的核心價值主張，Signatera 的臨床實用性正持續獲得認可。

At the ASCO meeting in June, Signatera was featured in over a dozen publications, and I wanted to highlight one particular multi-institutional study for UCLA and other academic institutions that really nicely delineates this clinical utility.

在 6 月的 ASCO 會議上，Signatera 在十幾篇出版物中被重點介紹，我想重點介紹一項由加州大學洛杉磯分校和其他學術機構開展的多機構研究，該研究很好地闡述了這種臨床用途。

As highlighted on this slide, this study examined 464 patients with Stage 1 to 3 breast cancer. The vast majority of the patients tested Signatera negative, offering valuable reassurance in a time of high anxiety. In the 12% of patients who tested Signatera positive, investigators reported a treatment change in 91% of these patients, with evidence that treatment change resulted in possibly improved outcomes.

如本投影片所示，本研究調查了 464 名第 1 期至第 3 期乳癌患者。絕大多數患者的 Signatera 檢測結果均為陰性，這在人們高度焦慮的時期帶來了寶貴的安慰。在 Signatera 檢測呈陽性的 12% 的患者中，研究人員報告稱，其中 91% 的患者改變了治療方案，有證據表明，治療方案的改變可能改善了治療結果。

Some of you will remember the INTERCEPT study in colorectal cancer from MD Anderson. This study is very similar but in breast cancer. This is a great showcase of how Signatera is being adopted into clinical practice and having a positive impact for patients across the country.

你們當中有些可能還記得安德森癌症中心所進行的大腸直腸癌 INTERCEPT 研究。這項研究與此非常相似，但它研究的是乳癌。這充分展現了 Signatera 如何被應用於臨床實踐，並為全國各地的患者帶來正面影響。

We are also pleased to publish several new peer-reviewed publications during this quarter, including the expanded EBLIS study, which we discussed in the Q1 call. But since then, there have also been new studies in muscle invasive bladder cancer, pancreatic cancer, and Merkel cell carcinoma.

我們也很高興在本季度發表了幾篇新的同行評審出版物，包括我們在第一季電話會議上討論過的擴展版 EBLIS 研究。但自那以後，肌肉浸潤性膀胱癌、胰臟癌和梅克爾細胞癌方面也出現了新的研究。

The latter two represent first time publications for Signatera in these disease indications, and we believe they are both areas of significant clinical unmet need. For example, in the Merkel cell carcinoma paper, Signatera testing after curative treatment was associated with significantly higher risk of recurrence. The hazard ratio reported was 7.4. This outperformed established Merkel cell carcinoma risk factors currently being utilized by clinicians.

後兩項是 Signatera 首次在這些疾病適應症領域發表文章，我們認為這兩個領域都存在著重要的臨床未滿足需求。例如，在梅克爾細胞癌論文中，根治性治療後進行 Signatera 檢測與更高的復發風險有關。報告的風險比為 7.4。這優於目前臨床醫生使用的已確定的默克爾細胞癌風險因子。

We look forward to presenting these new indications to Medicare later this year, adding to the multiple submissions that are currently under review, and we will provide an update on these submissions in the future.

我們期待在今年稍後向 Medicare 提交這些新的適應症，這將使我們目前正在審查的多項申請更加完善，我們將在未來提供有關這些申請的最新資訊。

Looking ahead to future data readouts, we have a strong pipeline of prospective randomized trials that we believe could, if successful, further change clinical practice in the United States and globally. As Steve mentioned, the Altera investigators notified us of the need for more time for data review, analysis, and interpretation.

展望未來的數據解讀，我們擁有強大的前瞻性隨機試驗儲備，我們相信，如果這些試驗成功，將會進一步改變美國乃至全球的臨床實踐。正如史蒂夫所提到的，Altera 的調查人員通知我們，需要更多時間進行資料審查、分析和解釋。

So they plan to delay the study readout to ASCO GI in January. We defer to the PIs on the timing and look forward to announcing these results at that time. Meanwhile, we are looking forward to the readout of the new GALAXY data and the ESMO conference in September with 36-month outcomes being reported in over 2000 patients, and mature overall survival data being presented in addition to disease-free survival data. This will be the first-time perspective overall survival data in colorectal cancer that will be presented.

因此，他們計劃將向 ASCO GI 報告的研究結果推遲到 1 月公佈。我們尊重首席研究員對時間安排的意見，並期待屆時能公佈這些結果。同時，我們期待新的 GALAXY 數據和 9 月的 ESMO 會議的公佈，屆時將報告 2000 多名患者的 36 個月結果，以及成熟的總生存期數據和無疾病生存期數據。這將是首次公佈大腸直腸癌總體存活率數據。

Looking forward to 2025, 2026, and beyond, we have a full suite of Phase 3 studies in colorectal cancer, bladder cancer, and breast cancer, including both escalation and treatment on molecular recurrence studies. Furthermore, we have trials focused on de-escalation and some trials that span both of these indications. In bladder cancer, we're expecting to IMvigor011 trial to read out in 2025, where the MODERN trial also continue to enroll well after being recently opened.

展望 2025 年、2026 年及以後，我們在結直腸癌、膀胱癌和乳腺癌方面開展了一系列完整的 3 期研究，包括分子復發研究的升級治療和治療。此外，我們還有一些試驗著重於降級治療，以及一些涵蓋這兩種適應症的試驗。在膀胱癌方面，我們預計 IMvigor011 試驗將於 2025 年公佈結果，而 MODERN 試驗在最近啟動後也將繼續招募患者。

We also have important breast cancer trials that we've previously presented on. This is just a snapshot of our data pipeline, and we continue to invest in generating high-quality clinical evidence to achieve our vision of Signatera as part of standard clinical practice.

我們還有一些重要的乳癌試驗，之前我們已經做過報告。這只是我們數據管道的一個快照，我們將繼續投資產生高品質的臨床證據，以實現我們將 Signatera 作為標準臨床實踐一部分的願景。

I also want to provide an update on our early cancer detection program. We continue to make progress in developing a differentiated blood-based assay to detect colorectal cancer. We are finishing a study utilizing prospectively collected colonoscopy-matched average-risk blood samples supplemented by colorectal cancer samples. We look forward to sharing these results in the near future, and I will provide further details on our plans at that time.

我還想向大家報告我們的癌症早期檢測計畫的最新進展。我們在開發用於檢測大腸直腸癌的差異化血液檢測方法方面持續取得進展。我們正在完成一項研究，該研究利用前瞻性收集的大腸鏡檢查匹配的平均風險血液樣本，並輔以大腸癌樣本。我們期待在不久的將來與大家分享這些結果，屆時我將提供有關我們計劃的更多細節。

Now I will turn it over to Mike to cover the financials. Mike?

現在我將把財務部分交給麥克。麥克風？

Great. Thanks, Alex. The next slide is just a summary of the P&L in Q2 and the year-over-year progress. Steve covered the key points on revenues and margins. On the expense lines, just as a reminder, we've made several growth-oriented investments in SG&A over the past year.

偉大的。謝謝你，亞歷克斯。下一張投影片是第二季損益表和年比變動情況的總結。史蒂夫講解了有關收入和利潤率的關鍵要點。在費用方面，需要提醒的是，過去一年我們在銷售、一般及行政費用方面進行了幾項以成長為導向的投資。

For example, taking up the women's health sales team from Invitae, which is working out very well. We also had a modest step up in R&D and clinical trials. These measured increases in OpEx are consistent with the Q1 guide, and I think are indicative of how we would like to proceed for the time being.

例如，從 Invitae 收購了女性健康銷售團隊，目前進展非常順利。我們在研發和臨床試驗方面也略有進展。這些營運支出的實際成長與第一季的指導方針一致，我認為這表明了我們目前希望採取的行動方式。

We'd like to maximize investments to grow revenues and margins while holding our cash balance relatively constant. That's what we achieved here in the second quarter and we are able to break even despite the seasonal headwinds that Steve described, and our cash balance actually grew slightly with interest income.

我們希望在保持現金餘額相對穩定的同時，最大限度地提高投資回報率和利潤率。這就是我們在第二季度取得的成就，儘管面臨史蒂夫所描述的季節性不利因素，我們仍然實現了收支平衡，而且由於利息收入，我們的現金餘額實際上略有增長。

Okay. Let's get to the revised financial guidance on the next slide. On revenues, we are now expecting $1.490 billion to $1.520 billion. This represents a bump of $70 million at the midpoint as compared to the roughly $30 million beat in the quarter when removing revenue true-ups Steve talked about. The annual revenue guide now implies about 40% revenue growth versus 2023.

好的。接下來我們來看下一頁修訂後的財務指引。營收方面，我們現在預計為 14.9 億美元至 15.2 億美元。這與史蒂夫提到的剔除收入調整後本季約 3,000 萬美元的超額收益相比，中間值增加了 7,000 萬美元。目前的年度營收預期表明，與 2023 年相比，營收將成長約 40%。

The guide also implies we are bullish on the second half of the year, and we are off to a good start so far in Q3. On pacing, we expect steady sequential growth in volumes and revenue in Q3 and Q4. Our guide always assumes $0 and true-up revenues in future periods. And if we continue to generate cash above our expectations in the second half, any true-ups would represent upside to our guidance.

該指南還暗示我們對下半年持樂觀態度，而且到目前為止，第三季開局良好。從發展速度來看，我們預計第三季和第四季銷售和營收將穩定成長。我們的指南始終假設初始收入為 0 美元，並在未來期間進行收入調整。如果下半年我們繼續創造超出預期的現金流，任何調整都將代表我們業績指引的上調。

We are also modeling largely stable ASPs in the second half for the overall business. So we do expect to see continued modest sequential improvement in the Signatera ASP, given the current momentum that Steve described. We are leaving the OpEx guide and the cash guide unchanged versus Q1, and we are still on track to make all the necessary growth investments we have planned for this year.

我們也預期下半年整體業務的平均售價將保持穩定。因此，鑑於史蒂夫所描述的當前勢頭，我們預計 Signatera 的平均售價將繼續小幅環比改善。我們維持營運支出指導方針和現金流指導方針與第一季保持一致，並且我們仍將按計劃進行今年所有必要的成長投資。

I'll repeat my disclaimer on cash burn. Now that we are operating at this breakeven level, it's important to understand that we expect to have fluctuations in quarterly cash burn due to timing of capital expenditures and working capital. The timing of reimbursement from payers can easily vary in a given quarter.

我再次聲明一下資金消耗的問題。既然我們目前處於損益平衡狀態，那麼需要了解的是，由於資本支出和營運資金的時間安排，我們預期季度現金消耗量會有波動。即使在同一個季度內，付款方的報銷時間也可能有較大差異。

So I wouldn't be surprised to have a quarter where we have negative cash flow and others where we are positive and the guide just represents the full-year results. The income statement, of course, is less prone to these swings. And so I expect our losses to continue to gradually narrow through the course of the year.

因此，如果某個季度出現負現金流，而其他季度出現正現金流，我不會感到驚訝，而該指引僅代表全年業績。當然，損益表受這些波動的影響較小。因此，我預計今年以來我們的虧損將持續逐步縮小。

Okay. So with that, we're very pleased with the quarter and happy to take your questions.

好的。綜上所述，我們對本季業績非常滿意，也樂意回答各位的問題。

Let me hand it to the operator. Operator?

讓我把它交給操作員。操作員？

(Operator Instructions) Dan Brennan, Cowen.

（操作員說明）Dan Brennan，Cowen。

Great. Thank you. Congrats on the quarter and thanks for the question. Maybe just on the clinical trial readouts on Altera and GALAXY. I appreciate the Altera readouts delayed just due to the PIs maybe more time. But is there anything to read into this at all from either given the time that they need from either the PFS or the OS that you might see coming out of this trial? And then on GALAXY, OS would be something, I understand this is an observational trial, not a randomized trial.

偉大的。謝謝。恭喜你本季取得好成績，感謝你的提問。或許只是根據 Altera 和 GALAXY 的臨床試驗結果來看。我理解 Altera 讀數延遲發布只是因為 PI 可能需要更多時間。但是，考慮到他們需要時間從 PFS 或 OS 數據中得出試驗結果，我們能否從中解讀出任何結論呢？至於 GALAXY，OS 可能是一個問題，據我了解，這是一項觀察性試驗，而不是隨機試驗。

So how do we think about the expectation here if we see an OS benefit, what that could actually mean either for doctor usage and/or NCCN?

那麼，如果我們看到 OS 帶來的好處，我們該如何看待這種預期？這對醫生使用和/或 NCCN 來說究竟意味著什麼？

Yes. Thanks, Dan. Good question. So yes, on Altera, I mean there's obviously a lot of work to do to get the patient data together and complete the analysis. And I think the timeline leading into ESMO was just a little bit too tight.

是的。謝謝你，丹。問得好。是的，在 Altera 平台上，顯然還有很多工作要做，才能收集到患者數據並完成分析。我認為 ESMO 的籌備時間安排有點太緊張了。

So the PIs want to move to the next large-scale conference, which is ASCO GI. And of course, we support that. But we're definitely excited about reading out the Galaxy 36-month data at ESMO. And I think for having the first perspective, overall survival data readout on Signatera is going to be a big milestone, and it's something that we're really excited about.

因此，PI們希望參加下一個大型會議，即ASCO GI。當然，我們支持這一點。但我們非常期待在 ESMO 上解讀 Galaxy 36 個月的數據。我認為，對於獲得第一個視角而言，Signatera 的整體生存數據讀數將是一個重要的里程碑，我們對此感到非常興奮。

So Alex, do you want to talk a little bit more about I think this readout coming up at ESMO?

那麼 Alex，你想再多談談我認為即將在 ESMO 上公佈的這份報告嗎？

Yes, definitely, Steve. Thanks for the question. For colorectal cancer and adjuvant setting three-month -- three-year DFS is usually considered the gold standard as we think about predicting overall survival. And I think the timing is perfect in that the overall survival data from the GALAXY cohort is also now maturing and we're able to read it out. So we think that provides two big upsides.

是的，當然，史蒂夫。謝謝你的提問。對於大腸直腸癌和輔助治療，3 個月至 3 年的無疾病存活期通常被認為是預測總存活期的黃金標準。我認為時機恰到好處，因為 GALAXY 隊列的整體生存數據也正在逐漸成熟，我們現在可以解讀這些數據了。所以我們認為這帶來了兩大優勢。

I think the first it shows how Signatera results predict with long-term outcomes, both DFS and OS. And it also builds a framework for looking at CTA dynamics as possible surrogates for future clinical trial development?

我認為首先，它顯示了 Signatera 的結果如何預測長期結果，包括 DFS 和 OS。它還建立了一個框架，用於將 CTA 動態作為未來臨床試驗開發的可能替代指標？

Great. And then if I have a follow-up just on pricing. True-ups have been obviously a big driver here in the last two quarters. I know you don't guide for that. Any way to characterize what that opportunity could look like?

偉大的。然後如果我還有關於價格的後續問題。在過去的兩個季度裡，調整顯然是造成這種情況的重要因素。我知道你在這方面沒有指導。有什麼方法可以描述一下這種機會可能會是什麼樣子嗎？

And then Mike, on Signatera price in the back half of the year, it sounds like I think from the last call, you were assuming flat pricing now, maybe you're assuming a step up in price. Maybe just discuss if anything changed there?

然後，Mike，關於 Signatera 在下半年的價格，聽起來從上次通話來看，你當時假設價格保持不變，現在也許你假設價格會上漲。或許可以討論一下那邊情況是否有改變？

Yes. Thanks for the question. So yes, on the true-ups, it wouldn't surprise me to see us have some additional true-ups. But again, they're just -- because they're hard to forecast is really more the reason why we don't guide to them. I do expect that to moderate.

是的。謝謝你的提問。所以，是的，關於調整，如果出現一些額外的調整，我不會感到驚訝。但話說回來，正是因為它們難以預測，這才是我們不做相關指引的真正原因。我預計這種情況會有所緩和。

I mean, we stepped up ASPs very meaningfully in response to the better cash collections that we've seen over the last 18 months or so. So I think as the ASPs go up, hopefully, the more of that revenue is showing to the accrual rather than a true up a year later. But nonetheless, I mean, this will be a process, I think so that's on true-ups. On pricing, yes. I mean, look, we've seen continued progress with the reimbursement for Signatera.

我的意思是，鑑於過去 18 個月左右現金回收情況的改善，我們大幅提高了平均售價。所以我認為，隨著平均售價上漲，希望有更多的收入能計入應計收入，而不是一年後才進行調整。但無論如何，我的意思是，這將是一個過程，我認為，所以這需要進行調整。價格方面，是的。我的意思是，你看，我們在 Signatera 的報銷方面已經取得了持續進展。

And we think that, that can yield some -- the guide presumes some modest step ups in the ASP in the second half but not something heroic beyond what we think is imminently achievable just based on reimbursement from Medicare and Medicare Advantage payers.

我們認為，這可以帶來一些——該指南假定下半年平均銷售價格 (ASP) 會有一些小幅上漲，但不會超出我們認為僅憑聯邦醫療保險和聯邦醫療保險優勢計劃支付方的報銷就能實現的驚人幅度。

Rachel Vatnsdal, JPMorgan.

Rachel Vatnsdal，摩根大通。

So first up on women's health, free to see the continued progress there this quarter, especially given the typical seasonality dynamics -- so can you break out for us what was the contribution from the fetal test that you guys highlighted? And then also on the Invitae side, can you walk us through how much did Invitae benefit? You talked about some of the increasing of the sales force there. So how should we think about that contribution in the back half?

首先說說女性健康，很高興看到本季在這方面取得的持續進展，尤其考慮到典型的季節性變化——那麼，你們能否詳細介紹一下你們重點提到的胎兒檢測的貢獻是什麼？另外，關於 Invitae 這邊，您能否詳細介紹 Invitae 從中獲得了多少收益？您剛才提到了那裡銷售團隊規模的擴大。那我們該如何看待下半場的貢獻呢？

Yes. Thanks a lot. So yes, we were really excited to launch the fetal RHD test. It seemed like we were meeting what is -- continues to be a very significant unmet need. And we've seen a lot of interest in -- continuing interest, particularly, I think, leading to us closing new customers.

是的。多謝。所以，是的，我們非常興奮地推出了胎兒 RHD 檢測。我們似乎滿足了一個非常重要的、尚未被滿足的需求——而這種需求至今仍然存在。我們看到了很多興趣——持續的興趣，尤其是我認為，這促使我們獲得了新客戶。

And one of the things that drove this outperformance in Q2 was an increase in new customers as we came out of Q1, and then that continued on in Q2. And a lot of that is from the organic growth of the women's health business.

第二季業績超預期的原因之一是，第一季結束後新客戶數量增加，而這一趨勢在第二季得以延續。其中很大一部分成長來自女性健康業務的自然成長。

So of course, Invitae made a contribution. I think we said in towards Q1 that Invitae was maybe like 25% of the women's health growth or something in that range. And I think it's similar in Q2 as now we're getting a full quarter of the Invitae volume coming in.

所以，Invitae當然也做出了貢獻。我認為我們在第一季左右說過，Invitae 可能佔女性健康成長的 25% 左右。我認為第二季的情況也類似，因為我們現在迎來了 Invitae 四分之一的業務量。

But a lot of the new volume coming in is organic growth that we're just continuing to see interest in the Natera prenatal portfolio.

但新增銷售量很大程度上是自然成長，我們看到消費者對 Natera 孕期產品組合的興趣持續成長。

Great. And then just on my follow-up, you had another really solid quarter on the gross margin front. So I guess, how should we think about this progress continuing into the back half of the year? And can you break down for us, especially on the Signatera side. You've mentioned some of the COGS dynamics.

偉大的。然後，我接著問一下，你們的毛利率又是一個表現非常穩健的季度。那麼，我們該如何看待這項進展能否延續到下半年呢？您能否為我們詳細解釋一下，特別是 Signatera 這方面的情況？您提到了一些成本動態。

How much of that gross margin progression on Signatera was due to getting into the subsequent test for patients versus that first test where you really do the whole sequencing but on the patient versus further operational efficiencies? And how do we think about that into the back half?

Signatera 的毛利率增長有多少是由於後續患者測試的開展，而不是由於首次測試中對患者進行完整的測序，以及進一步的運營效率提高？那麼，我們要如何考慮下半場的情況呢？

Mike, do you want to take that?

麥克，你想拿嗎？

Yes, sure. So yes, you're right. The gross margin guide is influenced, of course, by continued improvement in the Signatera gross margin. But I'd also highlight that the women's health ASPs are looking quite strong, as Steve mentioned in the call, we're very gratified to see that. Specifically, on the Signatera gross margin dynamics.

當然可以。是的，你說得對。當然，毛利率預期會受到 Signatera 毛利率持續改善的影響。但我還想強調，正如史蒂夫在電話中提到的那樣，女性健康領域的ASP（應用支援計畫）看起來相當強勁，我們對此感到非常欣慰。具體而言，是關於 Signatera 的毛利率動態。

We saw another modest step down in the COGS for Signatera sequentially versus Q1. And that is -- a lot of that, I think, is really related to the scale and the volume that we're seeing.

與第一季相比，Signatera 的銷售成本較上季略有下降。我認為這很大程度上與我們所看到的規模和數量有關。

There's still, I think, room to run in terms of reducing the COGS associated with running the tissue in-house, particularly as we stand up to Austin lab where we really get scale in that facility. So I think that's a positive driver for the back half. And I think if you just -- in terms of the gross margin progression, if you just think about the underlying non true-up progression we've seen here.

我認為，在降低內部組織處理的成本方面，我們還有提升的空間，尤其是在我們與奧斯汀實驗室競爭，我們在實驗室真正實現了規模化生產之後。所以我認為這對下半季來說是一個正面的推動因素。我認為，就毛利率的成長而言，如果你只是考慮一下我們在這裡看到的未調整的潛在成長。

I think you could still see modest sequential improvement in that underlying trend sequentially in Q3 and Q4. That's what the model implies.

我認為在第三季和第四季，這一潛在趨勢仍可能出現小幅較上季改善。這就是該模型所暗示的。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

If you don't mind, I'll ask both of them together on Altera, I just wanted to understand perspective from Alex. How should we -- I mean I appreciate that it's getting pushed out. But just in terms of overall benchmarking of this 240 patients trial, 80% powered to deliver DFS at a hazard ratio of 0.67. Is that the right benchmark? You've talked about the MOSAIQ trial before where Natera wasn't involved, but maybe just tell us how should we benchmark this?

如果你不介意的話，我會在 Altera 上同時問他們兩個，我只想了解 Alex 的看法。我們應該怎麼做——我的意思是，我很感激它被推向市場。但就這項 240 名患者的試驗的整體基準而言，80% 的樣本量足以在風險比為 0.67 的情況下實現 DFS。這是正確的基準嗎？您之前談到 MOSAIQ 試驗，當時 Natera 沒有參與，但或許您可以告訴我們應該如何衡量這項試驗的結果？

And then a second question follow-up for Mike is on gross margin. What's behind the 54% to 56% gross margin estimate? I appreciate there is a true-up difference here. But is there anything else beyond that, that we need to consider?

接下來，麥克需要回答第二個問題，關於毛利率。54%至56%的毛利率預期背後有什麼依據？我知道這裡存在實際差異。除此之外，還有其他需要考慮的因素嗎？

Yes. Thanks, Puneet. Yes, Alex, why don't you go ahead and talk about what good looks like and then you can hand it to Mike.

是的。謝謝你，普尼特。是的，亞歷克斯，你先說說你認為好的標準是什麼，然後你就可以把麥克風交給麥克了。

Yes. Thanks, Puneet, for the question. I think as we've previously discussed in I think we stand by that benchmark. Mosaic is, we think, the best DFS number to really target. I think that study showed a DFS of 0.0 0.77.

是的。謝謝 Puneet 的提問。我認為正如我們之前討論過的，我們堅持這個標準。我們認為，Mosaic 是 DFS 中最適合重點關注的數字。我認為那項研究顯示 DFS 為 0.0 0.77。

And it was the last study that led to a change in treatment guidelines in the adjuvant setting. So we think that's still the right number. And I think we are just awaiting the final results to be generated and reported out by the investigators, and we continue to look forward to those when they're available.

而正是這項研究最終促成了輔助治療指引的改變。所以我們認為這個數字仍然是正確的。我認為我們現在只是在等待調查人員得出最終結果並公佈，我們將繼續期待這些結果的公佈。

On the gross margin, yes, I mean, I think the key delta to me is just that the second half could just presume 0 and true-ups, right? So that's a key difference between first half and second half. I do think that backing out the true-ups, as I've mentioned, I think it's the organic underlying gross margin.

關於毛利率，是的，我的意思是，我認為關鍵的差異在於下半年可能只是假設為 0 並進行調整，對吧？這就是上半場和下半場的一個關鍵區別。正如我之前提到的，我認為剔除調整因素後，這才是真正的毛利率。

I think there's room for there to be sequential improvement both in Q3 and Q4. And so the guide is a blend of those couple of variables. So pretty bullish on the organic underlying gross margin progression.

我認為第三季和第四季都有可能持續進步。因此，該指南是這兩個變數的綜合體現。因此，我對有機毛利率的成長相當樂觀。

Okay. Got it. And if I could just squeeze a quick one around FMI. With the partnership termination, does that change your volume growth expectation for Altera or any impact on Signatera?

好的。知道了。如果我能抽出一點時間在FMI上快速回答一下就好了。合作關係終止後，這是否會改變您對 Altera 的銷售成長預期，或對 Signatera 產生任何影響？

Yes, thanks. That's a good question. No, we mentioned we're not continuing the partnership going forward, and it doesn't change our guidance or our volume forecast at all in any way.

好的，謝謝。這是個好問題。不，我們已經說過我們不會繼續這項合作，但這絲毫不會改變我們的業績指引或銷售預測。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Sticking with the Signatera theme, Alex, can you share some color on just in light of the delay here and ASCO GI, I think it's January 23. Is early next year the right time frame for when we can expect a top line readout from you guys? And then in terms of framing that readout, right?

繼續談到 Signatera 的主題，Alex，鑑於目前的延誤情況，你能分享一些關於 ASCO GI 的資訊嗎？我認為 ASCO GI 的舉辦日期是 1 月 23 日。明年年初是我們能從你們那裡得到主要業績報告的合適時間嗎？那麼，就如何呈現這些結果而言，對吧？

So should the trial not meet that 0.77 hazard ratio bar, you talked about. Do you think we could still get enough evidence from the subgroup level analysis to demonstrate that Signatera performed as it should and it was the drug that failed to meet the bar. Just any color on those two points would be great.

那麼，如果試驗結果沒有達到您所說的 0.77 的風險比標準呢？您認為我們是否還能從亞組分析中獲得足夠的證據來證明 Signatera 的表現符合預期，而未能達到標準的是其他藥物？這兩個點用任何顏色塗一下都可以。

Yes. So maybe I'll comment on the readout and then, Alex, you can talk about the performance. So yes, I think as we've got a ways out here now from ASCO GI, which is the next major conference. And as we get closer there, we'll discuss the communication plan.

是的。所以也許我會對讀數發表一些評論，然後，Alex，你可以談談表現了。是的，我認為距離下一個重要會議 ASCO GI 還有一段時間。隨著時間臨近，我們將討論溝通計劃。

I think with -- we were planning to read out top line results if they were available a couple of weeks before the conference, but we'll meet with the PIs and decide what we want to do as we get a little closer to ASCO GI.

我認為——我們原本計劃在會議召開前幾週公佈初步結果（如果結果可用的話），但我們會與首席研究員們會面，並在 ASCO GI 會議臨近時決定我們想做什麼。

Alex, do you want to talk about some of the subgroup analysis?

Alex，你想談談一些亞組分析嗎？

Yes, definitely. So I think the first question about asset performance. Signatera is being used in GALAXY. Altera is obviously a portion of that study. We published on assay performance in GALAXY.

是的，當然。所以我認為第一個問題是關於資產表現的。Signatera 正在 GALAXY 中使用。Altera 顯然是這項研究的一部分。我們在 GALAXY 中發表了關於檢測性能的研究成果。

We're updating the performance estimates at ESMO, and that will also be published. So in terms of assay performance concerns, I think the data is out there and it's been published, and I think that's what we expect.

我們正在更新 ESMO 的效能評估，更新後的資料也將發布。所以就檢測效能問題而言，我認為數據已經公佈，而且我認為這就是我們所期望的。

Now in terms of subgroup analyses, here, I just don't even want to speculate. I think we're awaiting the final results. And depending what the results show, subgroup analyses may be important, may not be important. They're prespecified. So we'll take a look at those as soon as that data is available to us as well.

至於亞組分析方面，我實在不想妄加猜測。我想我們都在等待最終結果。根據結果顯示的情況，亞組分析可能很重要，也可能不重要。它們是預先設定的。所以，一旦我們獲得這些數據，我們就會立即進行查看。

Got it. That's helpful. And then just as a follow-up, one of your competitors recently talked about greater physician preference for tumor-naïve approaches in the surveillance setting. Just due to apparently a lack of conviction that a tumor-informed approach can continue to provide relevant results given the time since diagnosis. So I'm just curious as to your take on that.

知道了。那很有幫助。然後，作為後續報道，你們的一位競爭對手最近談到，醫生們更傾向於在監測環境中採用未感染腫瘤的方法。顯然是因為缺乏信心，認為在確診後一段時間內，以腫瘤為導向的方法仍能提供相關的結果。所以我很好奇你對此有何看法。

And as we think about your MRD pipeline, you've got a few things in the hopper here. Is that one aspect that you will look to address either via an improved version of Signatera, perhaps a broader tumor informed panel or a tumor-naïve approach of your own?

當我們考慮您的 MRD 流程時，您這裡有幾個專案正在進行中。您是否打算透過改進 Signatera、擴大腫瘤知情小組或採用您自己的不涉及腫瘤的方法來解決這一方面？

Yes. So we think at this point, the decision on whether tumor and for tumor-naïve is going to be more successful. I think as it's pretty clear, right? If you just look at the volume and the physician interest in the marketplace. And a question about tumor dynamics over time, that's not really relevant.

是的。因此我們認為，在這一點上，對於腫瘤患者和未患有腫瘤的患者，做出是否進行腫瘤治療的決定將會更加成功。我覺得這很明顯，對吧？如果只看市場交易量和醫生對市場的興趣。至於腫瘤隨時間變化的動態變化問題，其實並不相關。

I think generally, we're looking at coronal mutations that are present even if there's developments in the tumor over time. So I don't really think the way that it's being described is relevant. Look, we always keep our eye out on what's happening with competition, what's happening in the marketplace.

我認為總的來說，我們看到的是即使腫瘤隨著時間的推移而變化，仍然存在的冠狀突變。所以我認為這種描述方式並不恰當。你看，我們始終密切注意競爭對手的動向和市場動態。

And obviously, we've been successful doing innovative things and innovating and evolving products over time, and we'll continue to do that as the market evolves. But I think at this point, things are pretty clear, the tumor-informed approach is clearly the chosen approach by physician.

顯然，我們一直以來都成功地進行創新，並不斷改進和完善產品，隨著市場的發展，我們將繼續這樣做。但我認為目前情況已經很清楚了，以腫瘤為導向的治療方法顯然是醫生選擇的方法。

Got it. Super helpful, guys. One final one for me. Just on ACOG, Steve, as you think about that as a catalyst, I mean, it's still in the framework, but do you think it happens between now and year-end? Or you just don't know and it's -- there's a possibility that this could slip to 2025?

知道了。太有幫助了，夥計們。最後再補充一個。史蒂夫，就 ACOG 而言，你認為這會是一個催化劑嗎？我的意思是，它仍在框架內，但你認為它會在現在到年底之間發生嗎？或者你根本不知道，有可能——這件事會推遲到 2025 年？

Yes. I think we still feel very positive about ACOG guidelines, both for carrier screening and on 22q, and that's really grounded in looking at the data, looking at physician preferences and looking at the studies that have been done. So I think you will -- well, we expect to see something this year, and we feel very strongly that things are coming.

是的。我認為我們仍然對 ACOG 指南持非常積極的態度，無論是攜帶者篩檢還是 22q 綜合徵，這都是基於對數據、醫生偏好和已完成的研究的認真分析。所以我覺得你們會——嗯，我們預計今年會看到一些事情發生，我們強烈地感覺到一些事情即將發生。

Matt Sykes, Goldman Sachs.

馬特·賽克斯，高盛集團。

Congrats on the quarter. My first one is, do you expect ASPs in women's health to decline at all for the second half, assuming ASPs, you mentioned will be stable in the second half with the sequential step-up in Signatera ASPs?

恭喜你本季取得佳績。我的第一個問題是，假設您提到的下半年平均售價將保持穩定，並且 Signatera 的平均售價將逐步提高，您是否預計下半年女性健康領域的平均價格會下降？

It's Mike. I'll take that one. Thanks for the question. No, we actually model stable ASPs in the women's health space for the second half. So do not expect a decline, which as the long-term follower in the car will recall, and that's a little bit of a deviation from the way that we typically guide.

是麥克。我選那個。謝謝你的提問。不，我們實際上對下半年女性健康領域的平均售價進行了穩定建模。所以不要指望下跌，長期關注此市場的投資者應該還記得這一點，這與我們通常的指導方式略有不同。

We've historically guided to some erosion in the ASPs, but that's just inconsistent with the momentum that we've seen in the women's health space. We've seen just continued progress really across the board in getting that long tail of recalcitrant payers that just reimburse particularly for NIPT.

從歷史上看，我們的目標客戶群（ASP）有所下降，但這與我們在女性健康領域看到的成長動能並不一致。我們看到，在爭取那些不願意支付NIPT費用的長期付款方方面，我們已經取得了持續的全面進展。

Now that it's been the standard of care for a few years now, you get this conversion of that long tail of payers, and we're definitely seeing that now. So feeling very good about the women's health ASPs at this time.

現在這種療法已經成為標準療法好幾年了，因此，很長一段時間以來，支付方都在逐漸轉變，我們現在確實看到了這種轉變。所以目前我對女性健康ASP計畫感到非常滿意。

Got it. And then is the CIRCULATE-France study that you're expecting data from shortly? Is that similar to the CIRCULATE-Japan study does it also have an escalation and de-escalation arm? And what are you expecting there incrementally that's potentially different from the Japan study?

知道了。那麼，您期待很快獲得數據的是 CIRCULATE-France 研究嗎？這與 CIRCULATE-Japan 研究類似嗎？它也有升級和降級策略嗎？那麼，您預計在那裡會有哪些與日本研究可能不同的逐步發現？

Yes. Alex, do you want to take that?

是的。亞歷克斯，你想拿嗎？

Yes, absolutely. So CIRCULATE-France, we're looking at the lower risk Stage 2 patient population where the benefit of adjuvant chemotherapy is hotly debated. The majority of patients in the -- probably the world are now giving adjuvant chemotherapy, but many of these patients still recur.

是的，絕對的。因此，在 CIRCULATE-France 研究中，我們關注的是風險較低的 2 期患者群體，而輔助化療的益處在該群體中一直備受爭議。目前世界上大多數患者都在接受輔助化療，但其中許多患者仍會復發。

So that is a study that's randomizing Signatera-positive patients after surgery in that narrow stage defined patient population to either receive adjuvant chemotherapy or follow the standard of care, which is observation. So in many ways, I would say it's pretty different than Altera and I was asking a postoperative adjuvant question.

這是一項研究，它將手術後 Signatera 陽性的患者（在特定分期的患者群體中）隨機分組，一組接受輔助化療，另一組接受標準治療（即觀察）。所以從很多方面來說，我認為它與 Altera 非常不同，而我當時問的是一個術後輔助治療的問題。

There is no de-escalation arm since, again, these patients as part of standard of care are not usually getting adjuvant chemotherapy. So the Signatera negative patients are being just followed and their outcomes are observed, but there is no randomized de-escalation component.

由於這些患者作為標準治療的一部分，通常不會接受輔助化療，因此沒有降級治療方案。因此，Signatera 檢測結果為陰性的患者只是接受隨訪，並觀察其治療結果，但沒有隨機降級治療方案。

Got it. And I forgot to mention this for Sean on for Matt.

知道了。我忘了跟肖恩和馬特提這件事。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

I want to just go through a few loose ends on Signatera. So -- actually, I want to come back to the topic of competition but let me put that to the side for a second. What's the mix of first-time tests versus surveillance as we sit here today? When you talk about COGS improvement, I'm assuming that's independent of mix. So that gets better even more so over time as the mix shifts towards more surveillance.

我想就 Signatera 的一些細節問題進行總結。所以——其實我想回到競爭這個主題，但讓我先把它放在一邊。目前來看，首次檢測和監測檢測的比例是多少？當你談到降低銷售成本時，我假設這與產品組合無關。隨著監控手段的增多，這種情況會隨著時間的推移而變得更好。

And then building off of this, keeping in mind that you seem to be on track to go Signatera revenue over 80% year-over-year. If we think of how you've been tracking on first-time tests, and then think about the annual tail of four more predictable tests per year for surveillance purposes the following year, and then you stack that on top of new first-time test growth. Doesn't that mathematically support an outlook for sustained 50% maybe more volume growth in the year ahead?

在此基礎上，考慮到 Signatera 的收入似乎預計將年增 80% 以上。如果我們考慮一下您是如何追蹤首次檢測的，然後再考慮一下每年為了監測目的而進行的四次可預測的檢測，然後再把這些檢測疊加到首次檢測的新增長之上。從數學角度來看，這不足以支持未來一年銷售持續成長 50% 甚至更高的預期嗎？

Thanks for the question, Doug. It's Mike. Yes, look, what we've seen is, first, when we launched Altera, obviously, there's very few surveillance tests in the cohort. Then we've grown to where historically, it's been gotten to like a 50-50 balance, and it has been quite stable there for some time. It's continued to evolve, but I would characterize it very broadly.

謝謝你的提問，道格。是麥克。是的，你看，我們看到的情況是，首先，當我們推出 Altera 時，很明顯，該隊列中很少有監測測試。然後，我們發展到如今，歷史上這種平衡已經達到了 50-50，並且已經穩定了一段時間。它一直在不斷發展演變，但我只能對其進行非常廣泛的描述。

It's still in that zone where you have very high compliance of patients staying with Signatera into the surveillance setting. And I think steady state, that's probably the vast majority of your volume, 75%, 80% of your volumes, like over time, mature product would be that tail of patients getting surveilled in the recurrence monitoring setting.

目前，接受 Signatera 治療的患者在監測環境下的依從性仍然非常高。我認為穩定狀態，這可能佔您業務量的絕大部分，75%、80%，隨著時間的推移，成熟產品將是復發監測環境中接受監測的那部分患者。

We haven't seen that progression happen as rapidly as you might expect because the top of the funnel just keeps getting filled. I mean they just continue to be new account when physicians adopting the test, new patients coming in the top of the funnel. And so that's kept that mix much more balanced, okay?

我們沒有看到這種進展像你預期的那樣迅速，因為漏斗頂部一直在不斷被填滿。我的意思是，隨著醫生採用這種檢測方法，就會不斷有新帳戶出現，新患者也會不斷湧入。這樣一來，這種組合就更平衡了，好嗎？

And so to your point, I do think that -- it's a unique dynamic, the fact that you've got this long-term ongoing relationship with the patient where you stack up classes of patients that stay with the test. It does support, I think, a longer-term outlook for growth potential that we're quite excited about because we think that can be extremely useful to patients over time. And you have the two-parter, and I'm only smart enough to remember one part. So I ask the second one again.

所以，正如你所說，我認為——這是一種獨特的動態，即你與患者建立了長期的持續關係，你積累了一批又一批堅持接受測試的患者。我認為，這確實支持了更長遠的成長潛力前景，我們對此感到非常興奮，因為我們認為隨著時間的推移，這對患者來說將非常有用。這部劇分為兩部分，而我只聰明到能記住其中一部分。所以我又問了第二個問題。

So I mean I think it was essentially just the COGS improvements that you talked about, that's independent of mix. And I think you just answered that because your mix is stable at 50-50. So I think we're going to like -- yes, exactly. -- yes. My follow-up is on competition.

所以我的意思是，我認為這本質上只是你提到的成本改進，這與混合比例無關。我認為你已經回答了這個問題，因為你的混合比例穩定在 50-50。所以我覺得我們會喜歡——是的，沒錯。 ——是的。我的後續問題是關於競爭的。

Garden reported data from the COSMOS study yesterday, specificity was 98%, sensitivity was 8. Recognizing that these studies are done in a way where it's hard to make perfect apples-to-apples comparisons. This seems to be well below certainly what we've seen in studies from you especially sensitivity, which, at least to me, looks like it was over 10 points lower.

Garden昨天公佈了COSMOS研究的數據，特異性為98%，敏感性為8。要認識這些研究的進行方式使得很難進行完全公平的比較。這似乎遠低於我們從你們的研究中看到的結果，尤其是敏感性，至少在我看來，似乎低了 10 個百分點以上。

That said, Garden is clearly asserting that their study data is actually better than what we've seen with Signatera. Are you seeing anything that suggests this is equivalent or better than what you guys have presented and based on what's out there, what part of the market positioning would be at risk for you and should we be contemplating any moderation in growth as folks potentially contemplate shifting to a study, which -- I'm sorry, an assay that may be more convenient.

也就是說，Garden 明確表示，他們的研究數據實際上比我們從 Signatera 看到的數據更好。你們有沒有看到任何跡象表明這和你們展示的產品一樣好或更好？根據目前的情況，你們的市場定位哪一部分會面臨風險？鑑於人們可能會考慮轉向研究（抱歉，應該是檢測），我們是否應該考慮放緩成長？

But from a performance standpoint, I think you'd have to once again view that convenience is more important than performance.

但從性能角度來看，我認為你還是得再次認為便利性比性能更重要。

Yes, thanks. so I guess I'll say Garden's been out since, I think, 2021 promoting their tests, and we've seen them in accounts. We've seen them in the field. And they announced, I think, the Kosmos results maybe in January of this year. So that's been out there for a while.

是的，謝謝。所以我想說，Garden 從 2021 年就開始推廣他們的測試了，我們在一些帳戶裡也看到過。我們在實地考察過它們。我想他們可能是在今年一月公佈了 Kosmos 的測試結果。這件事已經流傳一段時間了。

It's good that they've gotten the paper published. We don't think the dynamic really changes much. They've been out -- they've had the data out for seven months now. So I don't think it will impact much. We feel really good about our test performance.

他們能發表論文真是件好事。我們認為這種動態變化並不大。他們已經公佈數據七個月了。所以我覺得影響不會太大。我們對測驗成績非常滿意。

50 peer-reviewed publications plus multiple further studies in the pipeline. We're seeing 40% of oncologists use the product. Great operations. Things are going really well.

已發表 50 篇同行評審論文，另有多項研究正在進行中。我們發現有 40% 的腫瘤科醫師在使用該產品。運作出色。一切進展順利。

Tycho Peterson, Jefferies.

泰科·彼得森，傑富瑞集團。

A couple of cleanups here. I guess going back to Altera I just want to make sure I understand the pacing here. I think you previously talked about the CRC committee for NCCN meeting this summer and incorporating all tier. Now that's pushed out to next year. How do you think about timing of NCCN? And do you still think this is a driver versus strictly US? So that's the first question.

這裡需要做一些清理工作。我想回到 Altera 之後，我只是想確保我理解這裡的節奏。我認為您之前談到 NCCN 今年夏天召開的 CRC 委員會會議，並將所有層級納入其中。現在這件事被推遲到明年了。您如何看待NCCN發布的時間表？你仍然認為這是司機的問題，而不是我們自身的問題嗎？這是第一個問題。

Yes, I'll take that. So look, so first, we were happy to see Signatera and MRD testing being incorporated already as a footnote and NCCN based on the data that's out there. And we're excited about this 36-month perspective overall survival data that's going to be read out at ESMO, which we think is a very positive thing.

是的，我要了。所以，首先，我們很高興看到 Signatera 和 MRD 檢測已經作為腳註納入 NCCN，這是基於現有數據得出的結論。我們對即將在 ESMO 會議上公佈的 36 個月總生存期數據感到非常興奮，我們認為這是一件非常積極的事情。

The committee, I think, previously has said they're looking for overall survival data in a prospective manner. Of course, we're looking for randomized data as well, and that's what we're doing all of these randomized clinical trials.

我認為，委員會之前曾表示，他們正在以前瞻性的方式尋找整體生存數據。當然，我們也在尋找隨機數據，而這正是我們進行所有這些隨機臨床試驗的目的。

So we can't always predict what's going to happen with the NCCN committee. But certainly, doing all these studies, I think, puts us in a positive position. It's also important to remember, as Solomon described. I think, in his section, the different use cases of Signatera, right? So we have adjuvant decision-making, which is largely covered by the GALAXY study.

所以我們不能總是預測 NCCN 委員會會發生什麼。但我認為，進行所有這些研究無疑會讓我們處於有利地位。正如所羅門所描述的那樣，這一點也需要牢記。我認為，在他的部分中，他介紹了 Signatera 的不同使用案例，對嗎？因此，我們有了輔助治療決策，這主要由 GALAXY 研究涵蓋。

We then have surveillance with the notion of doing surgery with curative intent if you find a recurrence. And that's -- those two things are really driving a lot of the utilization today. And then you have the Altera study, which is looking at a new paradigm of treatment on molecular recurrence, but it's not necessarily the indication that's been driving all of the growth that we've seen today.

然後我們會進行監測，如果發現復發，則進行以治癒為目的的手術。而這兩件事正是目前推動能源利用率大幅提升的主因。此外，還有 Altera 研究，該研究著眼於分子復發治療的新範式，但這可能不是推動我們今天所見的所有增長的根本原因。

So look, we'll have to see, but we're doing everything we can. We're putting ourselves in the right position by doing these studies to see guidelines and see impact over time.

所以，我們拭目以待，但我們正在盡一切努力。我們透過進行這些研究，讓自己處於正確的位置，以便制定指導方針並觀察其隨時間推移產生的影響。

And then, I guess, on use cases. I think last quarter, you talked about some bumps in bladder cancer, ovarian cancer. Ovarian on the back of Medicare coverage. Can you maybe just talk a little bit about some of those newer indications and if you're doing anything around market development there?

然後，我想，還要看使用案例。我想上個季度，您談到了膀胱癌和卵巢癌的一些進展。卵巢癌的治療依賴醫療保險。您能否簡單談談一些新的適應症，以及您是否正在進行相關的市場開發工作？

Yes. So we're actually seeing a lot of interest in these other areas. And one of the things I think that is great about the Signatera strategy is that we've been able to generate peer review data and get coverage in multiple different indications now.

是的。所以，我們實際上看到大家對其他領域也表現出了濃厚的興趣。我認為 Signatera 策略最棒的一點是，我們已經能夠產生同儕審查數據，並且現在在多種不同的適應症中獲得覆蓋。

And in fact, in this last quarter, as Alex announced, we just had data on Merkel cell and now pancreatic cancer. So we're continuing to generate evidence in new tumor types, and those will all be submitted for MolDX.

事實上，正如 Alex 所宣布的那樣，在上個季度，我們剛剛獲得了梅克爾細胞癌的數據，現在又獲得了胰臟癌的數據。因此，我們正在繼續研究新的腫瘤類型，並將所有這些研究成果提交給 MolDX。

So when we've gotten coverage, we definitely see a bump as we go out and the sales team starts promoting in those indications. And then as we look towards 2025. Actually, one of the exciting areas I think, is bladder cancer with the IMvigor011 results potentially being read out in 2025. So we continue to see a lot of interest across the board, and we think that the pan-cancer approach backed by strong clinical data is the right approach.

所以當我們獲得健保覆蓋時，隨著銷售團隊開始針對這些適應症進行推廣，我們肯定會看到銷售量成長。然後，讓我們展望2025年。實際上，我認為令人興奮的領域之一是膀胱癌，IMvigor011 的結果可能會在 2025 年公佈。因此，我們看到各方對此表現出濃厚的興趣，我們認為，以強有力的臨床數據為支撐的泛癌治療方法是正確的方法。

Great. And then last one. Is it a little bit of a change in strategy on tumor naive for MRD. I think in the past, you talked about spending about $15 million this year on data sets and maybe some readouts just somewhere in the fall. Understanding, obviously, it's a smaller part of the market, not a huge focus, but I think you previously talked about spending on tumor naive.

偉大的。然後是最後一個。對於腫瘤初治患者進行微小殘留病灶（MRD）檢測，策略上是否略有改變？我記得你之前說過，今年要花大約 1500 萬美元購買資料集，也許秋季會公佈一些數據結果。顯然，這只是市場份額較小的一部分，並不是我們關注的重點，但我認為您之前談到過對腫瘤初治患者的投入。

Yes. So I think we've -- what we've said before is that we're definitely looking at the competition, understanding what's happening, understand what physicians are interested in. We definitely think tumor informed is, I think, a winning approach at this point.

是的。所以我覺得我們——就像我們之前說過的那樣——我們肯定會關注競爭對手，了解正在發生的事情，了解醫生們感興趣的是什麼。我們認為，以腫瘤為導向的方法，在目前來說，絕對是一種成功的策略。

But certainly, we are aware of what's happening in the marketplace and what types of test physicians are using. I think we've said we're innovating and we're doing different things, and we expect to announce some different MRD enhancements and product line extensions in the future.

當然，我們了解市場上的動態以及醫生正在使用的檢測類型。我認為我們已經說過，我們正在進行創新，正在做不同的事情，我們預計未來會宣布一些不同的 MRD 改進和產品線擴展。

And I think we'll just have to wait and see what those are. As far as early cancer detection, I think that's generally where we've talked about having that spend in the range of like $10 million to $15 million and having some readouts coming later this year, and those are actually on track. So we expect in the very near future to be able to give a readout on our progress in early cancer detection, which we're excited about.

我想我們只能拭目以待了。至於癌症早期檢測，我認為我們通常討論的是投入 1000 萬到 1500 萬美元，並在今年晚些時候公佈一些結果，而這些進展目前都在按計劃進行。因此，我們預計在不久的將來就能公佈我們在癌症早期檢測方面取得的進展，對此我們感到非常興奮。

Catherine Schulte, Baird.

凱瑟琳舒爾特，貝爾德。

Maybe first on women's health ASPs, just regarding your comments on improving the fraction of tests you get paid on even without guidelines. Does that hold true on [microdels]? Are you seeing improved collections there? Or was that more of a carrier screening comment?

或許首先應該談談女性健康 ASP，就你提出的即使沒有指導方針也要提高獲得報酬的檢測比例的建議而言。這個說法是否成立？[微缺失]？你那邊的收藏情況有改善嗎？或者，這更像是對攜帶者篩檢的評論？

Yes, Catherine, good question. I'd say that's not the case on [microdels]. I think there -- the improvement is really going to come from a guideline change. I think what we're talking about is where there's a covered test and maybe the payers aren't paying when they're supposed to. And you need to really do things with the payer to try to make sure you get paid, like, for example, collecting medical records, appealing after an unjust denial, things like that.

是的，凱瑟琳，問得好。我認為情況並非如此。[微缺失]。我認為，真正的改進將來自於指導方針的改變。我認為我們討論的是，有些檢測項目在醫療保險範圍內，但付款方可能沒有按規定付款。你需要和付款方一起做些事情來確保你能收到付款，例如收集醫療記錄、在被不公正地拒絕付款後提出上訴等等。

And we're just getting better at that as time goes on and we learn more. But certainly, the upside on something that generally doesn't have coverage like microdeletions still rests with guidelines and getting coverage in place.

隨著時間的推移和我們學習的深入，我們在這方面也越來越得心應手。但可以肯定的是，像微刪除這種通常不受法律保障的事情，其前景仍取決於相關指南和法律保障的落實。

Okay. Got it. And then for Signatera, you mentioned, I think, over 40% of oncologists ordered it in the second quarter. What percent have ordered it at all cumulatively since launch? And what portion of your sequential volume growth was from new ordering physicians versus penetrating existing accounts?

好的。知道了。至於 Signatera，您提到過，我認為，超過 40% 的腫瘤科醫生在第二季度訂購了該藥物。自產品上市以來，累計有多少百分比的人訂購過該產品？你們的銷售成長中，有多少比例來自新訂購醫生，又有多少比例來自現有客戶的拓展？

Yes. So we actually see -- once doctors start using Signatera, they're generally pretty consistent. But obviously, there's groups across the board that have different ordering patterns. But I would say the typical pattern is they trial it out on a couple of patients, they like the experience, they see the clinical utility and then they start expanding into their practice, into other patients. Maybe other doctors within the practice start ordering the test.

是的。所以我們實際上看到——一旦醫生開始使用 Signatera，他們的用藥通常就相當一致。但很顯然，各群體都有不同的訂購模式。但我認為，通常的做法是先在幾個病人身上試用，他們喜歡這種體驗，看到了臨床實用性，然後就開始在他們的實踐中推廣到其他病人身上。或許診所裡的其他醫生也會開始開這項檢查。

And then maybe they move beyond colorectal. Would be around breast to other tumor types. And so I would say that once people get on board, generally, there's a very strong rate of recurrent orders and expansion within those practices.

然後，他們或許會進一步研究大腸直腸癌以外的疾病。可能包括乳癌和其他類型的腫瘤。因此，我認為一旦人們接受了這種方式，通常情況下，這些實踐中就會出現非常強勁的重複訂單率和擴張速度。

Now with that said, we definitely track new physicians coming on board, and we see a very healthy pipeline there of new physicians coming in with interest that maybe they were waiting for more data to come out, maybe they just -- they hadn't decided on the right timing for them to use it yet, but we're certainly seeing a lot of new people come in, in addition to expansion within the physicians that are currently using.

話雖如此，我們確實在追蹤新醫生的加入，而且我們看到有非常健康的醫生儲備，他們對此很感興趣，也許他們一直在等待更多數據公佈，也許他們只是——他們還沒有決定何時使用，但我們確實看到很多新人加入，此外，目前正在使用的醫生群體也在擴大。

Subbu Nambi, Guggenheim.

蘇布南比，古根漢美術館。

Do you believe that the delay in the Altera readout will have any impact on market demand. I don't think so, but just wanted to confirm any signs that clinicians were holding off on adopting pending the readout?

您認為 Altera 資料公佈延遲會對市場需求產生任何影響嗎？我不這麼認為，但只是想確認一下，是否有任何跡象表明臨床醫生在等待結果出來之前暫緩採用這種方法？

Yes, that's a good question. So just as a reminder, what Altera is studying is a new paradigm, which is treatment on molecular recurrence where you would need to go get approval for this particular drug to be used without clinical relapse. And so the vast, vast majority of the usage that we've seen today and the growth that we're seeing is based on different indications.

是的，這是個好問題。所以再次提醒一下，Altera 正在研究的是一種新的範式，即針對分子復發的治療，你需要獲得批准才能使用這種特定的藥物，而無需考慮臨床復發。因此，我們今天看到的絕大多數使用情況和成長都是基於不同的指標。

And those indications are adjuvant decision-making, where the doctor is trying to make a decision about whether to give adjuvant chemotherapy or not. That's not being studied in Altera or just standard surveillance and recurrence monitoring for the intent of doing surgery because in colorectal cancer, in a significant portion of the patients, if you catch the cancer early, you can actually do surgery.

這些指徵是輔助決策，醫生需要根據這些指徵來決定是否進行輔助化療。Altera 並沒有研究這個問題，也沒有進行標準的監測和復發監測以決定是否進行手術，因為在結直腸癌中，如果早期發現癌症，很大一部分患者實際上可以進行手術。

And in many cases, the patients can be cured just from that surgery alone. So neither of those 2 indications are being studied in Altera. So the delay, obviously, won't have any impact on the current status quo. And I think we remain excited about reading the results out as we turn the corner into 2025 and potentially expanding the market opportunity further.

在許多情況下，僅透過手術就能治癒患者。因此，Altera公司並未研究這兩種適應症。因此，很顯然，此次延誤不會對現狀產生任何影響。我認為，隨著我們邁入 2025 年，並​​有可能進一步擴大市場機會，我們仍然對公佈結果感到興奮。

Okay. That's super helpful. And consistently, our checks on Altera trial, it appears that even if it reads out positive, it could be practice changing just like what you said, a new use case. But if it reads out negative, Signatera ordering behavior wouldn't be impacted because I think they point out the trial design is complicated and there are multiple subgroups. Is this how you're thinking about it internally?

好的。這太有幫助了。而且，我們對 Altera 試驗的檢查結果始終表明，即使結果呈陽性，也可能像您所說的那樣，改變實踐，產生新的用例。但如果結果為陰性，Signatera 的訂購行為也不會受到影響，因為我認為他們會指出試驗設計很複雜，而且有多個亞組。你內心是這樣想的嗎？

Yes. I mean, look, we've thought about it as potentially opening up a new area of growth. This idea of treatment on molecular recurrence. And I think that's really the view of how we're looking at things. And of course, the core volume growth today and all the utilization or the vast majority utilization that we're seeing.

是的。我的意思是，你看，我們已經考慮過這有可能開闢一個新的成長領域。這種基於分子復發的治療理念。我認為這確實是我們看待事物的方式。當然，還有目前的核心銷售成長以及我們看到的絕大多數產能利用率。

And we're still very, very underpenetrated, I think, are on adjuvant decision-making and recurrence monitoring with the intent to do surgery. So we'll have to see how things go after the data reads out and what additional uptake we get from this.

我認為，我們在輔助治療決策和復發監測方面，以及在進行手術治療方面的滲透率仍然非常非常低。所以，我們得看看數據出來之後情況如何，以及我們能從中獲得多少額外的市佔率。

Eve Berstein, Bernstein.

伊芙·伯恩斯坦，伯恩斯坦。

Great. Two for you. First one, you said that your base case is to add 9,000 to 10,000 Signatera tests per quarter. At this point, though, you've had two quarters in a row with test growth, clearly well above that. So two parts to this.

偉大的。給你兩個。首先，您提到您的基本情況是每季增加 9,000 到 10,000 次 Signatera 測試。不過，目前你們已經連續兩季實現了測驗成績成長，明顯遠超預期。所以這件事包含兩個部分。

One is part of the reason you've given for anchoring on that 9,000 to 10,000 members because you don't plan to increase your sales force. But you're clearly seeing interest from the market. So why not increase sales force at this point?

其中一個原因是，你之所以將會員人數定在 9000 到 10000 人，是因為你不打算增加銷售人員。但很明顯，市場對此很感興趣。那麼，為什麼不趁此機會增加銷售人員呢？

And then two, given that strong tailwind from surveillance, even if you don't increase sales force, you'll have that working in your favor. So don't you think it's reasonable to increase the base case at this point?

其次，鑑於監控帶來的強勁推動力，即使你不增加銷售人員，這也將對你有利。所以你不認為現在提高基本情況的適用範圍是合理的嗎？

Yes, that's a good question. And look, we're in a very underpenetrated market. There's lots of demand. We've been growing. We have seen 2 really strong quarters in a row, a very solid volume growth.

是的，這是個好問題。你看，我們身處在一個滲透率非常低的市場。需求量很大。我們一直在發展壯大。我們已經連續兩個季度實現了非常強勁的業績成長，銷量也實現了非常穩健的成長。

But look, I think we have to just stay conservative with our expectations as we normally are and try to outperform them, which we generally have been able to do. But look, it's hard to -- you can't judge things on a quarter-to-quarter basis because there's -- sometimes there's a different number of receiving days.

但是，我認為我們應該像往常一樣保持保守的預期，並努力超越預期，而我們通常也都能做到這一點。但是，你看，很難——你不能按季度來判斷事情，因為——有時候收貨天數會不一樣。

Sometimes there's holidays. Sometimes there's big major conferences where doctors are at. And so I think part of the point of just reiterating the base case is just because things can fluctuate every quarter. But when you take a step back, you look at an annual basis, I think that's probably a better way to look at things.

有時候會有假期。有時候會有一些醫生參加的大型會議。所以我認為重申基本情況的部分原因在於，情況每季都可能出現波動。但是，如果你退後一步，從年度角度來看，我認為這可能是一種更好的看待問題的方式。

But of course, we've given the same pitch before about the 8,000 to 9,000. I think we reiterated that in Q1, and then we delivered 13,000 units of growth. So it's just a standard baseline that we keep reiterating and has nothing to do with our views on exactly how the next particular quarter is going.

當然，我們之前也曾提出類似的方案，目標是 8,000 到 9,000 人。我認為我們在第一季重申了這一點，然後我們實現了 13,000 單位的成長。所以這只是一個我們不斷重申的標準基準，與我們對下一個特定季度具體情況的看法無關。

Got it. As a follow-up -- following up on the partnership with Foundation, you said that deciding not to renew that isn't changing your guidance or your forecast in any way. That partnership made a lot of sense strategically because you could piggyback off the 150,000 or 200,000 therapy selection tests they were doing and Altera is clearly well below that.

知道了。作為後續問題—關於與基金會的合作關係，您表示決定不再續約並不會以任何方式改變您的指導或預測。從策略角度來看，這種合作關係非常有意義，因為你可以利用他們正在進行的 15 萬或 20 萬次治療選擇測試，而 Altera 的測試數量顯然遠低於這個數字。

So if you're not changing your forecast, it makes me think that the partnership wasn't really delivering a ton of value. Why not? And why not fix the things that weren't going right for you? And then what, if anything, will you plan to change about your Altera marketing going forward to try to drive volumes there? Because I imagine that they, in turn, really could drive volumes for Signatera.

所以，如果你不改變你的預測，這讓我覺得這段合作關係並沒有真正帶來太多價值。為什麼不呢？為什麼不去解決那些對你來說不順利的事情呢？那麼，為了提高 Altera 的銷售量，您接下來會針對 Altera 的行銷做出哪些改變（如果有的話）？因為我認為，反過來，它們真的可以為 Signatera 帶來銷量。

Yes, I would say, look, when you look back to when we signed the partnership back in 2019, I mean, things have really changed quite a bit since then, right? So Signatera growth has accelerated and grown immensely.

是的，我想說，回顧我們2019年簽署合作協議的時候，我的意思是，從那時起，情況真的發生了很大的變化，對吧？因此，Signatera 的成長速度加快，規模也大幅擴大。

And we're just in a very different place than we were back when we sell that partnership. And as a reminder, we were running the plasma test, but the partner laboratory was responsible for commercial distribution. And that can be a challenging situation to be in.

我們現在的處境和當初出售合夥關係時已經截然不同了。再次提醒大家，我們負責進行血漿檢測，但合作實驗室負責商業分銷。這可能是個充滿挑戰的處境。

And I think for business reasons, both sides decided that it didn't make sense to continue. But like I said, it doesn't impact our forecast. We're focusing on Signatera, the opportunity that we have with Altera, which I think we're doing really well on.

我認為出於商業原因，雙方都認為繼續下去沒有意義。但就像我說的，這不會影響我們的預測。我們目前專注於 Signatera，以及我們與 Altera 的合作機會，我認為我們在這方面做得非常出色。

We continue to do really well in immunotherapy monitoring where we've had very strong data where a lot of times, we see the Altera being ordered alongside those immunotherapy monitoring patients. So we're continuing to move forward in that indication, but it just doesn't make a lot of sense anymore to continue the partnership. It's -- we'll move it along.

我們在免疫療法監測方面繼續表現出色，我們獲得了非常強大的數據，很多時候，我們看到 Altera 與免疫療法監測患者一起使用。因此，我們將繼續推進這項研究，但繼續合作已經沒有太大意義了。我們會繼續推進這件事。

Okay. Thanks a lot.

好的。多謝。

We are out of time for questions today. This will conclude today's conference call. Thank you for your participation. You may now disconnect.

今天提問時間已到。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。