Natera Inc (NTRA) 2025 Q1 法說會逐字稿

Welcome to Natera's 2025 first quarter financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded on May 8, 2025. I would now like to turn the conference call over to Michael Brophy, Chief Financial Officer. Please go ahead.

歡迎參加 Natera 2025 年第一季財務業績電話會議。（操作員指示）提醒一下，本次電話會議將於 2025 年 5 月 8 日錄製。現在，我想將電話會議交給財務長 Michael Brophy。請繼續。

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our first quarter of 2025.

謝謝，接線生。午安.感謝您參加我們的電話會議討論我們 2025 年第一季的業績。

On the line, I'm joined by Steve Chapman, our CEO; and Solomon Moshkevich, President, Clinical Diagnostics; Alex Aleshin, General Manager of Oncology will be available for Q&A. 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 website as it's available.

在線上，我們和我們的執行長史蒂夫·查普曼 (Steve Chapman) 連線；以及臨床診斷總裁 Solomon Moshkevich；腫瘤科總經理 Alex Aleshin 將接受問答。今天的電話會議透過網路直播。我們將參考已發佈到 investor.natera.com 的幻燈片簡報。通話重播也將在可用時發佈到我們的 IR 網站上。

Starting on slide 2. During the course of this conference call, we will be making forward-looking statements regarding future events and our anticipated future performance, such as our operational and financial outlook and projections, 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.

從投影片 2 開始。在本次電話會議期間，我們將對未來事件和預期的未來業績做出前瞻性陳述，例如我們的營運和財務前景和預測、我們對該前景的假設、市場規模、合作夥伴關係、臨床研究和預期結果、機會和策略以及對各種當前和未來產品的期望，包括產品功能、預期發布日期、報銷範圍以及對我們的財務和營運結果的相關影響。

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

我們提醒您，此類聲明反映了我們根據目前已知的因素做出的最佳判斷，實際事件或結果可能存在重大差異。請參閱我們不時向美國證券交易委員會提交的文件，包括我們最新的 10-K 表或 10-Q 表以及與今天的新聞稿一起提交的 8-K 表。

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, May 8, 2025. If this call is replayed or reviewed today, the information presented during the call may not contain current or accurate information.

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（2025 年 5 月 8 日）。如果今天重播或回顧此通話，通話期間提供的資訊可能不包含最新或準確的資訊。

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

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，但除非我們在公開論壇上這樣做，否則我們不會提供任何進一步的指導或有關本季業績的更新。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，否則每個參考值都代表同比比較。

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

現在我想把電話轉給史蒂夫。史蒂夫？

Thanks, Mike. Let's get to the highlights on the next slide. We generated $502 million in revenue this quarter compared to $368 million in Q1 of last year, which represents approximately 37% growth. We had an outstanding volume quarter across the board with 855,000 units processed in the quarter. This included a big step-up in women's health volumes in [Q4] of last year and a record volume quarter for Signatera.

謝謝，麥克。讓我們看看下一張投影片上的重點內容。本季我們的營收為 5.02 億美元，而去年第一季為 3.68 億美元，成長了約 37%。本季我們的銷售量整體表現優異，共處理了 855,000 個單位。其中包括去年第四季女性健康產品的銷售大幅成長，以及 Signatera 本季銷售創紀錄。

Signatera clinical volumes grew 52% year-on-year and increased by roughly 16,500 units compared to Q4, which is our best sequential unit quarter yet for Signatera. Gross margins were 63% in the quarter. And when you back out true-ups, grew more than 110 basis points just compared to Q4. So we're feeling great about the margin expansion we are still seeing in the business. We also generated $23 million in cash even as we doubled down on growth investments as we discussed on the Q4 call in February.

Signatera 臨床銷量年增 52%，與第四季度相比增加了約 16,500 個單位，這是我們迄今為止 Signatera 連續銷量最好的一個季度。本季毛利率為63%。而當你退出真實數據時，與第四季相比，成長了 110 多個基點。因此，我們對業務中仍然看到的利潤率擴張感到非常高興。正如我們在 2 月第四季電話會議上所討論的那樣，即使我們將成長投資增加了一倍，我們也仍然獲得了 2,300 萬美元的現金。

With all this momentum, we are in a position to substantially raise the revenue guide for the remainder of the year. We now expect revenues to be in the range of $1.94 billion to $2.02 billion this year, a raise of $70 million from the midpoint of our prior guidance given just a few months ago. This implies about 26% revenue growth year-on-year, ex true-ups, which is really strong. For strategic highlights in the business, starting off most recently at ISHLT, we shared a positive readout of the prospective DEFINE study in heart transplantation, which demonstrated Prospera's ability to predict clinical outcomes in heart transplant.

憑藉這一勢頭，我們能夠大幅提高今年剩餘時間的收入預期。我們現在預計今年的營收將在 19.4 億美元至 20.2 億美元之間，比幾個月前給出的預期中位數高出 7,000 萬美元。這意味著營收年增約 26%（不含實際成長），這一成長動能非常強勁。對於業務的策略亮點，最近從 ISHLT 開始，我們分享了心臟移植領域前瞻性 DEFINE 研究的積極讀數，該研究證明了 Prospera 預測心臟移植臨床結果的能力。

Remarkably, Prospera outperformed biopsy in predicting graft dysfunction one year after transplant. These also tested DQS or donor quantity score, which is a novel feature unique to Prospera. Prospera with DQS outperformed donor fraction alone in predicting graph dysfunction. Prior with DQS has outperformed over fractional loan was also published this week in a separate study in the American Journal of Transplantation. The paper reviewed the head-to-head performance of donor quantity score DQS versus donor fraction alone and found a DQS performed with higher accuracy.

值得注意的是，Prospera 在預測移植一年後移植物功能障礙的表現優於切片檢查。這些也測試了 DQS 或捐贈者數量分數，這是 Prospera 獨有的新功能。具有 DQS 的 Prospera 在預測圖表功能障礙方面比單獨的捐贈者分數表現更好。本週，《美國移植雜誌》的另一項研究也發表了 DQS 先前優於部分貸款的研究結果。本文回顧了捐贈者數量評分 DQS 與單獨的捐贈者分數的直接對比表現，發現 DQS 的準確度更高。

Solomon will discuss this further later in the call. Next week, we'll attend the ESMO breast annual meeting. Most notably, we look forward to a presentation on the I-SPY 2 trial which is a great collaboration that has produced strong data on Signatera in different settings in breast cancer.

所羅門將在稍後的電話會議中進一步討論此事。下週，我們將參加ESMO乳腺年會。最值得注意的是，我們期待 I-SPY 2 試驗的報告，這是一次偉大的合作，它為 Signatera 在乳癌的不同環境下的應用提供了強有力的數據。

This particular trial will report on the ability of Signatera to pick outcomes for metastatic recurrence and high-risk early-stage breast cancer. It's especially novel as it looks at the neoadjuvant setting and measure ctDNA levels at diagnosis prior to treat. In the study, Signatera's unique goes beyond just positive and negative results to categorize positive patents by cure quantity and then shows the five-year recurrence-free survival, which correlates with that quantity.

這項特別試驗將報告 Signatera 選擇轉移性復發和高風險早期乳癌結果的能力。它特別新穎，因為它關注新輔助治療環境並在治療前測量診斷時的 ctDNA 水平。在研究中，Signatera 的獨特之處在於它超越了陽性和陰性結果，根據治癒數量對陽性患者進行分類，然後顯示與該數量相關的五年無復發生存期。

While serial testing and ctDNA dynamics will certainly help further refine a patient's trajectory we are seeing a significant amount of clinical information coming from the single blood draw prior to any treatment beginning. Later this month at ASCO will have the largest and broadest set of data that we've ever had with more than 25 presentations on a wide range of tumor types, including 6 oral presentations. We have 8 in breast cancer alone, several in colorectal and GU, 2 real-world evidence studies based on our proprietary database and a large-scale readout of our Signatera genome test.

雖然連續測試和 ctDNA 動態肯定有助於進一步改善患者的軌跡，但我們發現在任何治療開始之前的單次抽血中可以獲得大量臨床資訊。本月晚些時候，ASCO 將發布迄今為止規模最大、範圍最廣的數據集，其中包括 25 場關於多種腫瘤類型的演講，其中包括 6 場口頭演講。我們僅在乳癌領域就有 8 項研究，在結直腸癌和泌尿生殖道領域有幾項研究，還有 2 項基於我們專有資料庫的真實世界證據研究和一項 Signatera 基因組測試的大規模讀數。

And finally, we're pleased to see critical findings in sarcoma from a Stanford-led study presented at the Society of Surgical Oncology Conference last month. With more than 2,100 samples, this is the largest sarcoma study in ctDNA analysis to date, and the results were excellent. Sarcoma is an important indication with 17,000 new diagnoses per year in the United States, so it's a similar size to ovarian cancer and it's a very important cancer type because there is significant unmet needs that need to be addressed, and it's a tough cancer to treat. While we're setting our lead in breast, colorectal, muscle-invasive bladder lung and the other initial histologies we're making significant progress in other tumor types.

最後，我們很高興看到上個月在外科腫瘤學會會議上發表的史丹佛大學領導的一項關於肉瘤的研究的重要發現。這是迄今為止 ctDNA 分析領域規模最大的肉瘤研究，涉及樣本超過 2,100 個，結果非常出色。肉瘤是一種重要的適應症，在美國每年有 17,000 例新診斷病例，因此其規模與卵巢癌相似，並且是一種非常重要的癌症類型，因為存在大量未滿足的需求需要解決，而且它是一種難以治療的癌症。我們在乳癌、大腸癌、肌肉層侵襲性膀胱癌、肺癌和其他初始組織學領域處於領先地位，同時，我們在其他腫瘤類型方面也取得了重大進展。

Sarcoma is just one example of many where this type of data will be reading out. Okay. So let's jump into some of the volume highlights on the next slide. As you see, we processed 850,000 tests in the quarter with strong growth across the business. This represents a sequential increase of 8% over Q4 of 2024, which is one of the best quarters we've ever had.

肉瘤只是眾多需要讀取此類數據的例子中的一個。好的。那麼讓我們來看看下一張投影片中的一些亮點。如您所見，我們在本季度處理了 850,000 次測試，整個業務實現了強勁增長。這比 2024 年第四季環比成長 8%，這是我們有史以來最好的季度之一。

[Wood and self] had an outstanding quarter, growing more than 40,000 units sequentially in Q1 versus Q4 alone. This excellence extends what was a very strong 2024, where women's held through hundreds of thousands of units year-over-year even when excluding the impact of the VTEC. Organ Health was also very strong in the quarter, but we saw north of 50% year-on-year growth in Oregon Health and a lot of interest in our donor-derived cell-free DNA and germline test.

[Wood 和我們自己] 本季表現出色，第一季和第四季的銷售量較上季成長超過 40,000 輛。這一優異表現延續了 2024 年的強勁表現，即使排除 VTEC 的影響，女性的人數也比去年同期增加了數十萬。器官健康在本季度也表現強勁，但我們看到俄勒岡健康年增超過 50%，人們對我們的捐贈者來源的無細胞 DNA 和種系測試產生了濃厚的興趣。

Okay. Moving on to oncology. The next slide shows the progression of Signatera clinical units over the last 8 quarters. We are very excited to see record growth quarter with 16,500 growth units over Q4, this is the fastest that we've ever grown and a testament to the strength of our technology, the breadth and quality of our clinical data and a great user experience we've built to help patients with cancer.

好的。繼續討論腫瘤學。下一張幻燈片展示了 Signatera 臨床部門在過去 8 個季度的進展。我們非常高興地看到，第四季度的成長單位數創下了 16,500 個的紀錄，這是我們有史以來成長最快的一次，證明了我們技術的實力、臨床數據的廣度和質量，以及我們為幫助癌症患者而建立的出色用戶體驗。

We estimate that over 45% of oncologists in the United States ordered a Signatera test last quarter. We think the next 2 years is an especially critical period for MRD, we evolve toward becoming the standard of care, and we are continuing to invest to expand clinical utility and to innovate to help as many patients as possible.

我們估計，上個季度美國有超過 45% 的腫瘤學家要求進行 Signatera 測試。我們認為未來兩年​​對 MRD 來說是一個特別關鍵的時期，我們將朝著成為護理標準的方向發展，並將繼續投資以擴大臨床實用性並進行創新，以幫助盡可能多的患者。

Okay. The next slide shows our revenue progression over the last six quarters. We're excited to cross the $500 million in revenue threshold for the first time in a single quarter. Despite the scale at which we're now operating, we still grew revenues 37% over Q1 of last year. In addition to the volume momentum, the investments we've made in our reimbursement operations continued to improve average selling prices in ASP strength across the board in women's health, organ health and oncology.

好的。下一張投影片展示了我們過去六個季度的營收成長情況。我們很高興單季營收首次突破 5 億美元大關。儘管我們目前的營運規模很大，但我們的收入仍然比去年第一季成長了 37%。除了銷售成長動能之外，我們在報銷業務方面所做的投資持續提高了婦女健康、器官健康和腫瘤學領域的平均銷售價格。

Signatera ASPs moved above $1,100 in the quarter, driven primarily by continued execution on securing Medicare Advantage reimbursement. All of this effort is allowing revenue growth to outpace volume growth. Of course, ASP growth has been a major driver of our margin expansion over time as well as this chart shows how we've moved from 39% to 63% in the last several quarters.

Signatera 的平均銷售價格在本季突破 1,100 美元，主要原因是繼續確保 Medicare Advantage 報銷。所有這些努力使得收入成長超過了銷量成長。當然，ASP 成長一直是我們利潤率擴張的主要驅動力，這張圖表顯示了過去幾季我們的利潤率如何從 39% 上升到 63%。

The 63% includes about $34 million in true-ups, and we're really pleased to see our underlying gross margin improvement, again, about 110 basis points from 59.3% in Q4 to 2024, to 60.4% Q1 of 2025. That gross margin improvement came from all the positive trends on ASPs and COGS were excellent again in the quarter across the business as we continue to get scale efficiencies from the robust volume growth.

63% 包括約 3,400 萬美元的實際利潤，我們非常高興地看到我們的基本毛利率再次提高，從 2024 年第四季的 59.3% 提高到 2025 年第一季的 60.4%，提高了約 110 個基點。毛利率的提高得益於平均售價的所有積極趨勢，而由於我們繼續從強勁的銷量成長中獲得規模效率，本季整個業務的銷貨成本再次表現出色。

We feel great about our gross margin trajectory as we look out over the next several years. In the near term, we expect Signatera ASPs to increase as we improve on our Medicare Advantage reimbursement, and we also hope to see some green shoots in biomarkers with commercial plans later this year, as we've previously discussed.

展望未來幾年，我們對毛利率走勢感到十分樂觀。短期內，隨著我們醫療保險優勢計劃報銷的改善，我們預計 Signatera 的平均銷售價格將會上漲，而且我們也希望在今年晚些時候看到生物標誌物在商業計劃中出現一些新的跡象，正如我們之前所討論的那樣。

Longer term, we've got some significant potential opportunities that could further drive margin improvements. guidelines in the United States and Japan for Signatera has the potential to move ASPs above $2,000 per test. We've made a ton of progress on the women's health side as well on ASPs but we still have carrier screening guidelines at 22q guidelines ahead of us. As we continue to grow share in Oregon Health, Prospera and arenas can both be accretive to gross margins as well.

從長遠來看，我們有一些重要的潛在機會，可以進一步推動利潤率的提高。美國和日本針對 Signatera 的指導方針有可能使每次測試的平均銷售價格超過 2,000 美元。我們在女性健康方面以及 ASP 方面取得了巨大進展，但我們仍然需要製定 22q 指南中的攜帶者篩檢指南。隨著我們在 Oregon Health 的份額不斷增長，Prospera 和 arenas 也都可以增加毛利率。

We previously described a longer-term goal to get gross margins above 70% over time, and I think we remain very well positioned to reach that target. We started this year with a guide to remain cash flow breakeven, and we were pleased to now generate $23 million for cash -- of cash in the quarter.

我們之前描述了一個長期目標，隨著時間的推移使毛利率達到 70% 以上，我認為我們仍然非常有能力實現這一目標。我們今年年初制定了保持現金流收支平衡的指導方針，我們很高興本季產生了 2,300 萬美元的現金。

We demonstrated in the second half of 2024, we are capable of generating much more free cash flow right now, but we see 2025 as a crucial investment year for us, particularly around Signatera. Given the potential size of the market, we think Signatera could eventually generate more than $5 billion in revenue annually. So it makes sense to continue funding high ROIC investments in commercial operations, clinical trials and product improvements. On that topic, we've never had a more exciting slate of data reading out across the business this summer, and I want Solomon to walk you through all of that data now. Solomon?

我們在 2024 年下半年證明，我們現在有能力產生更多的自由現金流，但我們認為 2025 年對我們來說是至關重要的投資年，尤其是在 Signatera 周圍。考慮到潛在的市場規模，我們認為 Signatera 最終每年可創造超過 50 億美元的收入。因此，繼續為商業營運、臨床試驗和產品改進提供高 ROIC 投資是有意義的。關於這個主題，今年夏天我們從未在整個行業中讀到過如此令人興奮的數據，我希望所羅門現在向你們介紹所有這些數據。所羅門？

Thanks, Steve, and good afternoon, everyone. I'll start off with Organ Health. Steve mentioned that we just published an important manuscript in the American Journal of Transplantation, the premier scientific journal in the field. This paper demonstrated the excellent results of our SKU threshold algorithm for Prospera, which combines donor fraction with the donor quantity score, also called DQS using this unique two threshold algorithm Respira with DQS delivered better sensitivity and specificity than donor fraction alone, including a 37% reduction in false positives.

謝謝，史蒂夫，大家下午好。我先從器官健康開始。史蒂夫提到，我們剛剛在該領域首屈一指的科學期刊《美國移植雜誌》上發表了一篇重要的手稿。本文展示了我們的 SKU 閾值演算法對於 Prospera 的出色結果，該演算法將供體分數與供體數量分數（也稱為 DQS）相結合，使用這種獨特的雙閾值演算法，帶有 DQS 的 Respira 比單獨的供體分數具有更好的靈敏度和特異性，包括將假陽性率降低了 37%。

The same algorithm was also evaluated in our DEFINE [HART] trial, which was presented last week at the IHLT Conference. As a reminder, the DEFINE trial is a large-scale prospective multicenter longitudinal study, a donor DNA in heart transplant patients. The objective of the study was to assess serial sell-through DNA dynamics and its association with clinical outcomes in the first year after heart transplant. We evaluated more than 100 patients and more than 1,000 samples, utilizing Prospera with DQS to measure levels of donor DNA in the blood.

我們在 DEFINE [HART] 試驗中也對相同的演算法進行了評估，該試驗於上週在 IHLT 會議上發表。提醒一下，DEFINE 試驗是一項大規模前瞻性多中心縱向研究，研究對象為心臟移植病患的捐贈者 DNA。研究的目的是評估連續銷售 DNA 動態及其與心臟移植後第一年臨床結果的關聯。我們評估了 100 多名患者和 1,000 多個樣本，利用 DQS 的 Prospera 測量血液中的捐贈者 DNA 水平。

The results showed that patients with at least one elevated Prospera results were significantly higher risk for experiencing an adverse event in the first year. which is defined as graft rejection, graft dysfunction, re-transplantation, or debt. In this trial, Prospera also outperformed serial biopsy by threefold in predicting graft dysfunction.

研究結果顯示，至少有一項 Prospera 結果升高的患者在第一年經歷不良事件的風險明顯較高。其定義為移植排斥、移植功能障礙、再移植或債務。在本次試驗中，Prospera 在預測移植物功能障礙的表現也比連續切片高三倍。

Before Prospera, endomyocardial biopsies used to be performed every month as part of standard surveillance in many heart transplant centers. Obviously, a highly undesirable procedure that carries inherent risk. But more and more, we are starting to see physicians replace biopsies with Prospera.

在 Prospera 出現之前，許多心臟移植中心每月都會進行心內膜心肌活檢，作為標準監測的一部分。顯然，這是一種非常不受歡迎的程序，具有固有的風險。但我們越來越多地看到醫生用 Prospera 代替活檢。

Turning now to oncology, where we continue to make excellent progress. At this month's ESMO Breast Congress coming up Munich, we're excited to present new data from multiple studies, including the I-SPY 2 trial that will highlight Signatera's ability to predict long-term items in early-stage breast cancer patients. The data from over 700 patients will show the testing Signatera negative at diagnosis is an extremely good prognostic market after being treated with surgery and chemotherapy. Not only with Signatera status at diagnosis, a highly significant predictor of outstream regardless of disease side, but the quantity of tumor burden, as measured by ctDNA was also correlated with [actions].

現在轉向腫瘤學，我們在該領域繼續取得優異進展。在本月即將於慕尼黑舉行的 ESMO 乳房大會上，我們很高興展示多項研究的新數據，其中包括 I-SPY 2 試驗，該試驗將強調 Signatera 預測早期乳癌患者長期計畫的能力。來自超過 700 名患者的數據表明，診斷時檢測 Signatera 呈陰性是接受手術和化療治療後極好的預後市場。不僅與診斷時的 Signatera 狀態有關（無論疾病側如何，Signatera 狀態都是流出的重要預測因子），而且透過 ctDNA 測量的腫瘤負擔數量也與[行動]。

This reflects Signatera's differentiated quantification capabilities, and it's the first time to our knowledge that anyone has demonstrated the clinical value of absolute ctDNA quantity at time of diagnosis. These findings open new therapeutic strategies, including the potential for Signatera negative patients to skip chemotherapy and other intensive forms of treatment. Questions that Natera will evaluate definitively in upcoming prospective trials.

這體現了Signatera差異化的量化能力，據我們所知，這是第一次有人證明診斷時絕對ctDNA量的臨床價值。這些發現開闢了新的治療策略，包括 Signatera 陰性患者有可能跳過化療和其他強化治療。Natera 將在即將進行的前瞻性試驗中對這些問題進行最終評估。

The data also highlights the benefit of starting Signatera testing at the earliest stage of a patient's treatment journey, right of diagnosis. The time we believe Signatera will become a standard component of the diagnostic workup for a breast cancer patient, much like testing for [HER2] status for hormone receptor status today.

數據也凸顯了在患者治療過程的最早階段（診斷階段）開始 Signatera 檢測的好處。我們相信 Signatera 將成為乳癌患者診斷檢查的標準組成部分，就像今天透過檢測 [HER2] 狀態來檢測荷爾蒙受體狀態一樣。

Beyond our data generation efforts in the core indications, we continue to pursue expansion into new histologies at a rapid pace. One such indication in sarcoma with over 17,000 new cases diagnosed in the U.S. every year. Because of the heterogeneous nature of this disease, both adjuvant and surveillance strategies tend to be highly individualized. Surveillance that can include frequent imaging for up to 10 years, highlighting concerns for radiation exposure in such patients.

除了在核心適應症方面進行資料生成工作之外，我們也持續快速尋求向新組織學的擴展。其中一種病症是肉瘤，美國每年診斷出超過 17,000 例新病例。由於這種疾病的異質性，輔助治療和監測策略都趨向高度個人化。監測包括長達 10 年的頻繁影像，強調對此類患者輻射暴露的擔憂。

There's a strong clinical unmet need here, which we think is ideal for Signatera. So we're very pleased about the recently presented sarcoma study out of Stanford University, showing the validity and utility of serial Signatera in over 200 sarcoma patients and more than 2,000 (inaudible). Representing to our knowledge, the largest study to date of ctDNA monitoring in sarcoma. The findings showed exceptional test performance, including overall recurrent sensitivity of 89% and specificity of 100%, these numbers were strong across subtypes, including some of the more clinically difficult to street histology like lime sarcoma, where the sensitivity was 93%.

這裡存在著強烈的未滿足臨床需求，我們認為這對 Signatera 來說是理想的。因此，我們對史丹佛大學最近發表的肉瘤研究感到非常高興，該研究顯示了一系列 Signatera 對 200 多名肉瘤患者和 2,000 多名（聽不清楚）患者的有效性和實用性。據我們所知，這是迄今為止對肉瘤 ctDNA 監測最大規模的研究。研究結果顯示出卓越的測試性能，包括 89% 的總體復發敏感性和 100% 的特異性，這些數字在各個亞型中都很強，包括一些臨床上更難街道組織學的腫瘤，如石灰肉瘤，其敏感性為 93%。

We look forward to these results being published and working more closely with the sarcoma community, for example, notary strategy to introduce and validate Signatera across all [ketotypes]. Looking ahead now, this will be a busy and exciting ASCO conference for Natera, with nearly 30 abstracts and presentations planned across multiple tumor types, including, as Steve noted, 6 oral presentations, 4 of those orals will be in breast cancer alone, 2 of which are in the neoadjuvant setting building off the momentum with the AXI trial. One of them will have interim results from our prospective randomized DARE trial, and the first breast cancer oral presentation will demonstrate the utility of treatment monitoring in the metastatic setting, which is something new.

我們期待這些結果的發表，並與肉瘤社區進行更緊密的合作，例如，透過公證策略在所有領域引入和驗證 Signatera[酮型]。展望未來，對於 Natera 來說，這將是一次忙碌而激動人心的 ASCO 會議，計劃在多種腫瘤類型中發表近 30 篇摘要和演講，包括史蒂夫指出的 6 篇口頭演講，其中 4 篇口頭演講僅針對乳腺癌，2 篇將在新輔助治療中藉助 AXI 試驗的勢頭進行。其中一項研究將公佈我們前瞻性隨機 DARE 試驗的中期結果，而第一份乳癌口頭報告將展示轉移性治療監測的實用性，這是一種新現象。

These studies started years ago, and the results will serve to further expand our data leadership in MRD. We also look forward to presenting posters with clinical performance data in [Merkel] cell carcinoma and other cancer types and a readout from our new signature genome asset.

這些研究幾年前就開始了，其結果將進一步擴大我們在 MRD 領域的數據領導地位。我們也期待展示包含[梅克爾]細胞癌和其他癌症類型臨床表現數據的海報以及我們新的簽名基因組資產的讀數。

As we announced previously, the genome version of Signatera is now broadly available. This version of the test leverages Natera's patented multiplex PCR technology and our targeted and desequencing approach. They detect ctDNA at frequencies as low as a single tumor copy per million. And it is being offered alongside the Signatera exome assay which itself regularly detects in the ultrasensitive range and can get down to the low single-digit parts per million as well.

正如我們之前宣布的那樣，Signatera 的基因組版本現已廣泛可用。此版本的測試利用了 Natera 的專利多重 PCR 技術和我們的標靶和去定序方法。它們檢測 ctDNA 的頻率低至每百萬個腫瘤拷貝中有一個。該技術與 Signatera 外顯子組檢測一起提供，該檢測本身可以定期檢測超靈敏範圍，並且也可以檢測至百萬分之個位數的低值。

At ASCO, we will present our first clinical data with Signatera genome. Encompassing hundreds of patients and thousands of plasma samples across multiple tumor types. The assay performance looks very strong with longitudinal sensitivity ranging from the 90% up to 100%, depending on histology and with specificity approaching 100%.

在 ASCO 上，我們將展示使用 Signatera 基因組的首批臨床數據。涵蓋數百名患者和數千份多種腫瘤類型的血漿樣本。此檢測性能看起來非常強，縱向靈敏度從 90% 到 100% 不等，取決於組織學，特異性接近 100%。

We believe the specificity is very important, and we're pleased to see that Signatera's high specificity is maintained even with the improved sensitivity of the genome. This is something where we have seen other MRV labs struggle with clinical specificity data that is low or simply not reported at all. We have generally seen competing MRD labs struggle with translating extreme analytical claims into clinical performance.

我們認為特異性非常重要，我們很高興地看到，即使基因組的敏感性提高，Signatera 的高特異性仍然得以維持。我們發現其他 MRV 實驗室在臨床特異性數據較低或根本沒有報告的情況下也遇到了相同的問題。我們通常看到競爭的 MRD 實驗室努力將極端的分析主張轉化為臨床表現。

Furthermore, we've developed a research version of our genome assay that's available to our academic and pharma collaborators, that will improve detection to levels even below a single part million, opening, we believe, even more research opportunities.

此外，我們還開發了基因組檢測的研究版本，可供我們的學術和製藥合作夥伴使用，這將把檢測水平提高到甚至低於百萬分之一的水平，我們相信，這將開闢更多的研究機會。

So we're really excited about what lies ahead. We've got a lot of incredible data reading out in the near future. As you can see from our continued strong volume growth, the medical community is responding positively to the utility of Signatera and we expect that trend to continue as we move ahead.

因此，我們對未來充滿期待。我們近期將會獲得大量令人難以置信的數據讀數。從我們持續強勁的銷售成長可以看出，醫學界對 Signatera 的效用反應積極，我們預計這種趨勢將持續下去。

So with that, I'll turn it over to Mike to cover the financials and the guide. Mike?

因此，我將把責任交給麥克負責財務和指南。麥克風？

Great. Thanks, Solomon. The first slide is just a summary of our Q1 financials. If you look at the year-on-year change, call in to the right, you'll get a sense of the progress we've made across every metric of the business. Steve covered the tear we've been on with respect to revenue growth driven by both volumes and ASPs.

偉大的。謝謝，所羅門。第一張投影片只是我們第一季財務狀況的摘要。如果您查看同比變化，請撥打右側電話，您將了解我們在業務的每個指標上所取得的進展。史蒂夫介紹了我們在銷售和平均售價推動的收入成長方面所取得的進展。

I was particularly pleased to see women's health units step up as strongly as they did just given the scale at which we are now operating. And of course, Organ Health and oncology just continue to ramp. If you strip out all true-ups from the gross margin line, we expanded gross margins by more than 800 basis points. from roughly 52% this time last year to north of 60% today.

鑑於我們目前的運作規模，我特別高興地看到婦女健康部門取得如此強勁的發展。當然，器官健康和腫瘤學也將繼續蓬勃發展。如果從毛利率中剔除所有調整值，我們的毛利率將擴大 800 多個基點。從去年同期的約 52% 上升到如今的 60% 以上。

All of that progress allowed us to generate cash and actually reduce our loss per share even as we significantly ramp R&D and SG&A to take advantage of the growth opportunities we have ahead of us, particularly in oncology. We maintained a pristine balance sheet with nearly $1 billion in cash and no debt outside of the relationship line of credit we have with UBS.

所有這些進展使我們能夠產生現金，並實際上減少了​​每股虧損，即使我們大幅增加研發和銷售、一般及行政開支，以利用我們面臨的成長機會，特別是在腫瘤學領域。我們的資產負債表保持完美，擁有近 10 億美元現金，除了與瑞銀的關係信用額度外，沒有其他債務。

Okay. Let's get to the updated 2025 guidance on the next slide. As Steve described, we are raising the revenue guide by about $70 million at the midpoint. This is our standard approach to the guide does not include any true-up revenues in future periods. So the $70 million bump implies rapid revenue growth for the full year just as Steve described.

好的。讓我們在下一張投影片中了解更新後的 2025 年指南。正如史蒂夫所描述的，我們將收入預期中位數提高了約 7,000 萬美元。這是我們的標準指南方法，不包括未來期間的任何真實收入。因此，正如史蒂夫所描述的那樣，7000 萬美元的增長意味著全年收入的快速增長。

We are holding the gross margin guide at 60% to 64% for the full year and the Q1 results put us in great position to land in that range. Given the organic gross margin was about [60.4%] in Q1, I think this guide again shows we are confident in the ASP and COGS trend we saw in Q1 are sustainable, and we've kept to edge in the gross margin guide to account for possible short-term headwinds we could get from the new products we're launching, so we haven't really seen much of that penalty just yet.

我們維持全年毛利率指引值在 60​​% 至 64% 之間，第一季的業績讓我們有很好機會達到這一範圍。鑑於第一季的有機毛利率約為 [60.4%]，我認為該指南再次表明我們對第一季度看到的平均銷售價格和銷貨成本趨勢的可持續性充滿信心，並且我們在毛利率指南中保持領先地位，以應對我們可能從即將推出的新產品中遇到的短期阻力，因此我們目前還沒有看到太多的損失。

For both revenue and gross margins. the guide does not require heroic improvements in the business trends versus Q1, but rather steady execution on the targets in front of us. We are also bumping SG&A and R&D modestly higher as we look to maximize out-year revenue growth. We expanded our commercial operations in Q4 and Q1, and those investments are on track to drive additional growth in 2016 and beyond.

無論是收入還是毛利率。該指南並未要求業務趨勢相對於第一季有顯著改善，而是要求穩定執行我們面前的目標。我們也適度提高了銷售、一般及行政費用和研發費用，以期實現未來年度收入成長最大化。我們在第四季度和第一季擴大了商業運營，這些投資預計在 2016 年及以後推動進一步成長。

The bump here in Q1 accounts for some noncash expense accruals and noncash charges related to stock-based comp, along with some (inaudible) staffing, we are putting into areas of the business where we are seeing high returns. For example, as John Fesko described in February, we've made a number of key hires focused on delivering AI-supported solutions in the revenue cycle operation and we are already seeing results that merit further investment.

第一季的成長考慮到了一些與股票薪酬相關的非現金費用應計和非現金費用，以及一些（聽不清楚）人員配置，我們將其投入到我們看到高回報的業務領域。例如，正如 John Fesko 在二月所描述的，我們已經進行了一些關鍵招聘，專注於在收入周期運營中提供人工智慧支援的解決方案，並且我們已經看到了值得進一步投資的成果。

On the R&D side, we are seeing additional opportunities to accelerate data generation. Some of the recent data sets we presented have [spanned] significant interest from the academic community, and we are running as hard as we can to make sure we have the key clinical trials needed to unlock more indications along the lines of what Solomon described in this section. These clinical trials have delivered extremely high ROICs in the past because they flow into bedrock for broader adoption and allow us to drive reimbursement across an ever wider range of tumor types.

在研發方面，我們看到了加速資料產生的更多機會。我們最近展示的一些數據集引起了學術界的極大興趣，我們正在竭盡全力確保我們擁有所需的關鍵臨床試驗，以便解鎖更多與所羅門在本節中所描述的類似的適應症。這些臨床試驗在過去已經取得了極高的 ROIC，因為它們成為更廣泛採用的基礎，並使我們能夠推動更廣泛的腫瘤類型的報銷。

The net of all business is that we're holding steady with our plans to remain cash flow breakeven. We're obviously off to a great start with $23 million in cash flow generation in Q1, and we'll be opportunistic with future investments for the balance of the year. Okay. With that, let's open it up to questions.

所有業務的淨結果是，我們堅持我們的計劃以保持現金流收支平衡。顯然，我們在第一季創造了 2,300 萬美元的現金流，這是一個很好的開端，我們將抓住機會，在今年餘下的時間裡進行未來的投資。好的。好了，讓我們開始提問吧。

(Operator Instructions) Dan Brennan, TD Cowen.

（操作員說明）Dan Brennan，TD Cowen。

Maybe the first one, obviously, the sequential volume growth in Signatera really solid. A bit above even what Mike and Steve, you guys kind of pointed to as we get into '25.

也許是第一個，顯然，Signatera 的連續銷售成長確實很穩健。甚至比麥克和史蒂夫所指出的還要高一點，因為我們正進入 25 年。

Can you just give a little flavor what's going on in the market, kind of what drove it? It just kind of volume was sustainable as we go through the year? And then I have a follow-up.

您能否簡單介紹一下市場目前的狀況以及推動其發展的因素？就我們全年的情況來看，這種數量是否可持續？然後我有一個後續問題。

Yes. Thanks, Dan. So obviously, we're really pleased, record sequential quarter in growth. And that's off the back of a couple of really strong quarters in a row. We're just seeing that the data that we generated the performance of the test, the very strong clinical utility is resonating with physicians.

是的。謝謝，丹。因此，顯然，我們真的很高興，實現了連續季度的成長。這是連續幾季表現強勁的結果。我們只是看到，我們產生的測試性能數據，其非常強大的臨床實用性引起了醫生的共鳴。

And that, combined with the large commercial presence that we have plus the very significant scale and user experience focus that we have, whether it's quick turnaround time, EMR capability, mobile phobotogy, all of those things are working and the volume is increasing.

而且，結合我們龐大的商業影響力、規模和對用戶體驗的重視，無論是快速的周轉時間、EMR 能力還是行動光電學，所有這些都在發揮作用，而且數量正在增加。

As far as kind of the rest of the year goes, we're not sort of changing the previous quarter-over-quarter sequential growth, which we said was around like 10,000 to 12,000 units roughly. But obviously, we are pleased with what we saw now. And we're seeing a lot of utilization and a lot of excitement as we move forward.

就今年剩餘時間的情況而言，我們不會改變之前的季度環比增長速度，我們之前說過，環比增長大約在 10,000 到 12,000 台左右。但顯然，我們對現在所看到的情況感到滿意。隨著我們不斷前進，我們看到了很多利用率和很多令人興奮的事情。

Great. And then just as a follow-up, a lot of clinical evidence coming up at ESMO and ASCO, I know you got into a few of the studies what you're most excited about on the [neoadjuvant] side. Which of these do you think -- I know, Mike, you talked about investment stepping up in R&D because the community wants to see these studies report out.

偉大的。然後作為後續行動，ESMO 和 ASCO 上出現了大量臨床證據，我知道您參與了一些研究，您對[新輔助]方面最感興趣。您認為其中哪一個——我知道，麥克，您談到加大對研發的投資，因為社區希望看到這些研究報告。

Which of these do you think we should focus in on say, over the next year or so that can really begin to move the needle on actual volumes in the marketplace?

您認為在接下來的一年左右的時間裡，我們應該專注於哪些方面，才能真正開始推動市場的實際銷售？

Yes. I'll just make some general comments and then maybe Alex, Solomon, if you want to comment.

是的。我只是做一些一般性的評論，然後也許亞歷克斯、所羅門，如果你們想評論的話。

First, I think we're incredibly excited to have more than 25 presentations at ASCO, including 6 oral presentations. That's really remarkable and a testament to the team and the academic PIs that we've worked with. Certainly, we've got a very strong presence in breast cancer, in gastrointestinal cancers, as 2 of the largest areas. I mean breast ISPY-2, when we announced today the DARE study, which is a randomized study looking at the concept of treatment on molecular relapse that's generating a lot of excitement.

首先，我認為我們非常高興能在 ASCO 上進行超過 25 場演講，其中包括 6 場口頭演講。這確實很了不起，也是對我們合作的團隊和學術 PI 的證明。當然，我們在乳癌和胃腸道癌症這兩個最大的領域中佔有非常強的地位。我的意思是乳癌 ISPY-2，我們今天宣布了 DARE 研究，這是一項隨機研究，研究分子復發治療的概念，引起了許多人的興奮。

So there's a lot of good data reading out, pan cancer, I think continuing the trend of having a data-driven approach. And remember, a lot of these trials started five years ago, right? So these aren't studies that you can sort of just drop in at the last second and run a randomized study. It takes a long time to get to this point. And we think this just continues the leadership position that we have in the space.

因此，有許多關於泛癌症的良好數據讀出，我認為繼續採用數據驅動的方法的趨勢。請記住，許多試驗都是五年前開始的，對吧？因此，這些研究並不是那種你可以在最後一秒突然介入並進行隨機研究的研究。要達到這一點需要很長時間。我們認為這將繼續鞏固我們在該領域的領導地位。

Solomon or Alex, do you want to add anything?

所羅門或亞歷克斯，你們還有什麼要補充嗎？

Yes. We're looking forward to the readout of the INVIGR-011 trial. Which were -- we've done in partnership with Genentech. That's their trial, so they're going to read that out, but we do expect that to be midyear. And that we think that will -- has the potential to really move the needle in GU with muscle invasive bladder cancer.

是的。我們期待 INVIGR-011 試驗的結果。這是我們與 Genentech 合作完成的。這是他們的審判，所以他們會宣讀判決，但我們確實預計那將是年中。我們認為，這有可能真正推動泌尿外科治療肌肉浸潤性膀胱癌的進展。

And if successful, that will be the first companion diagnostic label that we take through FDA. Alex?

如果成功的話，這將是我們透過 FDA 獲得的第一個伴隨診斷標籤。亞歷克斯？

No, I think that's a great summary. I would also just highlight, I think there are more and more smaller histologies, like we highlighted sarcoma, where we are starting to see data mature. And even though each engine by itself may be only 10,000, 15,000, 20,000 patients a year. In combination, that is a significant growth opportunity.

不，我認為這是一個很好的總結。我還想強調的是，我認為有越來越多的小組織學，例如我們強調的肉瘤，我們開始看到數據成熟。儘管每台引擎每年可能只能治療 10,000、15,000 或 20,000 名患者。綜合起來，這是一個重大的成長機會。

So I think -- we have data coming out in pancreatic, melanoma, gastroesophageal. So we're really excited to kind of share some of those data sets and really keep growing kind of the number of patients that segmentary can help through kind of market-leading evidence generation strategies.

所以我認為──我們有關於胰臟癌、黑色素瘤、胃食道癌的數據。因此，我們非常高興能夠分享一些數據集，並透過市場領先的證據產生策略真正不斷增加分段式治療可以幫助的患者數量。

Tejas Savant, Morgan Stanley.

摩根士丹利的 Tejas Savant。

A couple of ones on Signatera, actually. So maybe just to kick things off, One question that we've been getting a little bit is, is there a delta in terms of the number of tests reimbursed for breast versus CRC in the recurrent setting? And if so, do you have any studies underway to your point on more studies in response to physician and KOL sort of opinions, I guess, that could help define the optimal frequency of testing in the breast recurrent setting?

實際上，Signatera 上有幾個。因此，也許只是為了開始討論，我們一直在問的一個問題是，在復發的情況下，乳癌和 CRC 的報銷檢測數量是否存在差異？如果是這樣，您是否正在進行任何研究來回應醫生和 KOL 的意見，我想，這可以幫助確定乳房復發情況下的最佳檢測頻率？

Yes. So as we kind of go through the process of getting reimbursement with MolDx, part of that process is to sort of look at what the cadence is in the studies and what the standard kind of imaging cadences are. And those aren't always necessarily going to be the exact came same time points in each tumor site.

是的。因此，當我們透過 MolDx 獲得報銷的過程中，該過程的一部分是了解研究的節奏以及標準成像節奏。而這些並不一定總是出現在每個腫瘤部位的同一時間點。

So I would say without getting into kind of the details on each particular tumor side, you can just expect that there's going to be differences. I think sometimes it's 2 times a year in the surveillance setting, sometimes it's 4 times a year in the surveillance setting. Sometimes it's 2x a year for the first -- sorry, fourth time year for the first 3 years and then it's 2x a year thereafter.

因此我想說，無需深入研究每個特定腫瘤部位的細節，你就可以預料到其中會有差異。我認為有時在監視環境下每年是 2 次，有時在監視環境下每年是 4 次。有時第一年是 2 次——抱歉，前 3 年是第四年，之後每年是 2 次。

So of course, as we read out sort of the ASP currently, that includes tests that may be performed that may be intermediate between one of the reimbursed time points where we're not getting paid, and those are areas where we see opportunities. So of course, as Mike has talked about we think the Signatera ASP over time can be up to $2,000. And part of that is getting covered for tests that today we're not getting paid for. That includes tumor types where we're not covered but that also includes some of the fill-in for maybe time points that aren't necessarily covered today that we think could be covered.

因此，當然，正如我們目前讀出的 ASP 那樣，它包括可能在我們沒有得到報酬的報銷時間點之間進行的測試，而這些是我們看到機會的領域。因此，當然，正如 Mike 所說，我們認為 Signatera 的平均售價隨著時間的推移可以達到 2,000 美元。其中一部分是為了支付目前我們沒有得到報酬的測試費用。這包括我們尚未涵蓋的腫瘤類型，但也包括一些我們認為可以涵蓋但今天不一定涵蓋的時間點的填充。

Got it. That's helpful. And then quick cleanup for Mike here. Mike, did you guys see any disruption from either like weather or like calendar day dynamics in the first quarter? Clearly, you had a very strong quarter.

知道了。這很有幫助。然後在這裡為 Mike 快速清理一下。麥克，你們在第一季是否發現任何來自天氣或日曆日動態等方面的干擾？顯然，你們本季的業績非常強勁。

So I'm wondering if it could have been even better if that -- if those dynamics were in play at all? And then secondly, just in light of the strong sequential growth acceleration in Signatera volume, you're -- how are you thinking about revenue seasonality in the second quarter? Is flattish a fair assumption? Or do you think we could get a little bit of a dip in light of what you guys typically see in women's health?

所以我想知道，如果這些動力真的發揮作用的話，情況是否會變得更好？其次，鑑於 Signatera 銷售連續強勁成長，您如何看待第二季的營收季節性？平坦是一個合理的假設嗎？或者您認為，根據您通常看到的女性健康狀況來看，我們的健康狀況可能會下降嗎？

Yes, thanks for the question. I mean certainly, weather was a huge challenge in the quarter, particularly with respect to the wildfires in Southern California, that's a very important area of the country for us, very important territory. You'd be hard for us to see it in the volumes harbor. And that kind of harkens back to our experience in the pandemic, where if you just looked at our quarterly volume progression, it would be very difficult to determine that there was a massive lockdown and a huge societal disruption.

是的，謝謝你的提問。我的意思是，天氣確實是本季的一個巨大的挑戰，特別是南加州的野火，對我們來說，那是全國非常重要的地區，非常重要的領土。我們很難在海量港口中看到它。這讓人回想起我們在疫情中的經歷，如果你只看我們季度的交易量增長，就很難確定是否存在大規模的封鎖和巨大的社會混亂。

The reason for that is that these are time-sensitive kind of urgent tests that the patients need on a tight time horizon. And so what we have seen over and over again is that while weather can disrupt us for a period of time, ultimately, these patients need their NIPT. They need their [keroscreeing] test, they need their Signatera test, and they find a way to get back in relatively short order back to the physician's office and get that testing done.

原因在於，這些都是時間敏感的緊急測試，病人需要在緊迫的時間內進行。因此，我們一再看到的是，雖然天氣會在一段時間內幹擾我們，但最終，這些患者需要 NIPT。他們需要進行 [keroscreeing] 測試，需要進行 Signatera 測試，然後他們想辦法在相對較短的時間內回到醫生辦公室並完成測試。

I think that concept has massive implications for how efficient the commercialization model is for Natera relative to a lot of players even within the molecular diagnostics space. So weather was a huge issue in the quarter, but we were able to kind of power through it. As it relates to pacing through the rest of the year, I think the women's health pacing, I think, is kind of holding up true to form.

我認為這個概念對於 Natera 的商業化模式相對於分子診斷領域的許多參與者的效率具有重大影響。因此，天氣是本季的一個大問題，但我們能夠克服它。至於今年剩餘時間的步調，我認為女性健康的步調在某種程度上保持了原有的水平。

We generally expect Q1 to be a very strong volume quarter for women's health, then your same-store volumes drop off in Q2 and then they recover in Q3 and Q4. And that's just a function of when people show up in their OB/GYN's office to get the NIPT.

我們通常預期第一季女性健康產品的銷售量將非常強勁，然後同店銷售在第二季會下降，然後在第三季和第四季回升。這只是人們到婦產科辦公室接受 NIPT 檢測的一個功能。

In the background, of that. The new account wins are not really seasonal. I mean those are kind of happening in the background, but we have such a big book of existing business the same-store volumes, if you will, do you have a noticeable impact on volumes and, ultimately, revenues. Have you seen a little bit of that in prior years, although we've had some acquisitions and other things that have kind of -- that have obfuscated that trend. I expect that trend to be more noticeable here in 2025 because it's a fairly -- it's -- there's not a lot of exogenous factors kind of driving a difference for us for women's health.

在那個背景中。新帳戶的勝利實際上並不是季節性的。我的意思是，這些都是在幕後發生的，但我們有如此龐大的現有業務，同店銷售量，如果你願意的話，你會對銷售量和最終的收入產生明顯的影響嗎？您是否在前幾年看到過這種情況，儘管我們進行了一些收購和其他一些事情，但這些事情在某種程度上掩蓋了這種趨勢。我預期這種趨勢在 2025 年會更加明顯，因為這是一個相當明顯的趨勢，沒有太多的外生因素會對我們女性的健康狀況產生影響。

And then the other Signature is getting bigger and bigger, and that just continues to ramp Prospera getting bigger. The transplant business is getting bigger and bigger and that's to continue to ramp, we haven't really identified that there's some marked seasonality there, other than the point that I think you mentioned, Tejas, and we've tried to bring up in the past is that I wouldn't be too precious about the exact number of growth units per quarter, particularly for Signatera just because we're operating at a scale where a couple of days here or there in terms of number of days in the calendar for quarter holidays, things like that, that can throw that off.

然後另一個簽名變得越來越大，而這只會繼續推動 Prospera 變得越來越大。移植業務規模越來越大，而且還在繼續增長，我們還沒有真正發現其中存在明顯的季節性，除了我認為您提到的觀點，Tejas，以及我們過去試圖提出的觀點之外，我不會太在意每個季度增長單位的確切數量，特別是對於 Signatera 來說，因為我們的運營規模很大，就日曆上的季度假期天數而言，諸如這裡或那裡的幾天

But overall, I'd say I expect the standard seasonality in women's health to kind of affect the pacing and then the other businesses to continue to ramp.

但總的來說，我預計女性健康的標準季節性會對節奏產生一定影響，然後其他業務將繼續成長。

Rachel Vatnsdal, JPMorgan.

摩根大通的 Rachel Vatnsdal。

Congrats on another great quarter, you guys. So for (inaudible), I just wanted to ask on the Signatera volumes within the quarter. Can you walk us through which indication did you see the greatest sequential growth for Signatera volumes? And then kind of how do we see that road map from here in terms of indication contributing to growth for the rest of the year?

恭喜你們又度過了一個美好的季度。因此對於（聽不清楚），我只是想詢問本季內的 Signatera 銷售量。您能否向我們介紹哪些跡象顯示 Signatera 銷量實現了最大的連續成長？那麼，從指示角度來看，我們如何看待該路線圖對今年剩餘時間的成長的貢獻？

Yes, that's a great question. So we're really pan cancer at this point. So obviously, we're seeing a lot of interest across the board. That includes colorectal, breast, lung, muscle-invasive bladder, ovarian, standard immunotherapy monitoring across all different tumor types.

是的，這是一個很好的問題。所以我們現在確實處於泛癌症狀態。顯然，我們看到了各界的濃厚興趣。其中包括大腸直腸癌、乳癌、肺癌、肌肉侵襲性膀胱癌、卵巢癌以及所有不同類型腫瘤的標準免疫療法監測。

I think everyone sort of knows the colorectal is the largest indication. But certainly, there are several others that are really seeing a lot of interest. And we're doing well across the board. We're seeing very strong growth across all the tumor types. And I think that just again, like helps us kind of recognize how big of an opportunity this is.

我想每個人都知道大腸直腸癌是最大的適應症。但可以肯定的是，還有其他一些因素也確實引起了人們的極大興趣。我們的各方面表現都很好。我們看到所有類型的腫瘤都呈現非常強勁的成長動能。我認為這再次幫助我們認識到這是一個多麼大的機會。

We're really at the very early stages, but there's a lot of room for continued growth, and we've put ourselves in a position where we're now deep in the offices and as they start to order an expanded indications we're right there to partner with the physician to help more patients.

我們確實處於非常早期的階段，但仍有很大的持續增長空間，並且我們已經將自己置於現在深入辦公室的位置，當他們開始要求擴大適應症時，我們會立即與醫生合作，幫助更多的患者。

Great. And then just for my follow-up, I wanted to ask on screening. I didn't really talk about that as to in the prepared remarks. So can you walk us through what are you assuming on the screening front? You increased the R&D guide, is any of that to be tied to getting some data on the colorectal screening front as well?

偉大的。然後，為了跟進，我想詢問一下篩檢情況。我在準備好的發言中並沒有真正談論這一點。那麼，您能否向我們介紹一下您在篩選方面有何假設？您增加了研發指南，這是否也與取得結直腸篩檢的一些數據有關？

Yes, it's a good question. So as we said before, we have the [PRESIDE] study where they actually now met the goal of enrolling more than 3,000 patients. So that's basically done. We're now going to be reading that out toward the end of the year. So that's exciting.

是的，這是個好問題。正如我們之前所說，我們的 [PRESIDE] 研究實際上已經實現了招募 3,000 多名患者的目標。這樣基本上就完成了。我們現在將在年底前宣讀該決議。這很令人興奮。

That was the big perspective, colonoscopy match study that we had talked about previously.

這是我們之前討論過的大腸鏡檢查匹配研究的宏觀視角。

I would say, toward the end of the year, you'll get that big readout. And then the other main update is the FDA enabling study, the FIND study. We're actually expecting the first patient in on that this month, which is exciting. So as a reminder, that's basically designed in the same way as the PROCEED trial. PROCEED was designed itself to exactly match what you would do in an FDA enabling trial.

我想說，到今年年底，你會看到那個重要的讀數。另一個主要更新是 FDA 支持研究，即 FIND 研究。實際上，我們預計本月將迎來第一位患者，這令人興奮。所以提醒一下，它的設計基本上與 PROCEED 試驗相同。PROCEED 的設計本身與您在 FDA 授權試驗中所做的事情完全匹配。

So that data is super reliable. So we're just sort of picking up from there and the fact that we're already at first patient in targeted for this month is pretty exciting. You do see some of the R&D expense trickling in throughout 2025, but that's also going to be kind of built in 2026.

所以這些數據非常可靠。因此，我們只是從那裡開始，事實上我們已經成為本月的第一批目標患者，這非常令人興奮。你確實會看到一些研發費用在 2025 年逐漸增加，但這也將在 2026 年完成。

And that's in the models and in the guidance in the way kind of Mike is talking about the future of the business. We're already accounting for that.

這就是麥克在模型和指導中談論業務未來的方式。我們已經考慮到了這一點。

Tycho Peterson, Jefferies.

傑富瑞 (Jefferies) 的 Tycho Peterson。

This is Noah on for Tycho. I wanted to start by asking about ASPsfor the year, typically (inaudible) true-ups and things like that.

這是 Noah 為 Tycho 所做的。我想先問一下今年的 ASP，通常是（聽不清楚）真實情況之類的。

It was a bit garbled on my end. Can someone just repeat that for me.

我這邊有點混亂。有人能再給我重複一次嗎？

Just question was what's our sort of trajectory on ASP for the rest of the year? And what are the puts and takes on denials, true-ups coverage? How should we be thinking about that?

唯一的問題是，今年剩餘時間我們的 ASP 走勢如何？那麼，對於拒絕和真實報道，有哪些利弊呢？我們該如何思考這個問題？

Yes. I mean I think the guide contemplates kind of stable ASPs in the women's health business and the organ health business. and then some modest improvement coming from Signatera really areas where we feel like we've got a very clear line of sight on. This is things like increasing modestly, increasing the percentage of times we get allowed from Medicare Advantage for tumor types that are already objectively covered, and we should be getting paid 100% of the time. We're going to continue to grind that higher through the course of the year.

是的。我的意思是，我認為該指南考慮了女性健康業務和器官健康業務中穩定的平均銷售價格。 Signatera 確實在一些領域取得了一些適度的進步，讓我們感覺到我們已經對這些領域有了非常清晰的認識。這包括適度增加，增加我們獲得醫療保險優勢計劃 (Medicare Advantage) 涵蓋的腫瘤類型的次數百分比，並且我們應該 100% 獲得賠償。我們將在今年繼續努力，並不斷提高這個目標。

So I feel pretty good about that. As I mentioned in the prepared remarks, I think like the ASP guide and the kind of the revenue guide for the year does not require -- it requires good execution, but it doesn't require some heroic change in the conditions of the business. that we saw in Q1.

所以我對此感覺很好。正如我在準備好的演講中提到的那樣，我認為 ASP 指南和年度收入指南並不需要——它需要良好的執行，但不需要對業務條件進行一些重大改變。我們在第一季就看到過這種情況。

As it relates to true-ups, I mean, look, the -- I think on a percentage basis, you're seeing the true-ups kind of feathered down as expected as a percent of total revenue. In terms of absolute dollars, it's kind of a little bit hard to predict because the volume in the business is growing so rapidly. That's the reason why we don't guide with true-ups in the future periods.

至於真實收入，我的意思是，你看，我認為從百分比來看，你會看到真實收入佔總收入的百分比如預期那樣下降。就絕對美元而言，這有點難以預測，因為業務量成長如此之快。這就是我們不在未來時期使用真實值進行指導的原因。

So the guide for the rest of this year, it includes the $34 million in actual true-ups from Q1, obviously, because those are in the books. But for the remainder of the year, just presume 0, and that goes for the gross margin guide as well, if you ask me, will we have some true-ups, Yes, we will. They're just hard to predict, and I think they make it harder for you guys to model it, so we leave it out.

因此，今年剩餘時間的指南顯然包括第一季的 3,400 萬美元實際增值，因為這些都已記錄在案。但對於今年剩餘的時間，就假設為 0，這也適用於毛利率指南，如果你問我，我們會有一些調整，是的，我們會的。它們很難預測，而且我認為它們使你們更難對其進行建模，所以我們將其排除在外。

Great. Super helpful. And then for my follow-up, I just get a quick update on (inaudible) for MRD and what the time line is like there and what reception has been like in the other research environment?

偉大的。超有幫助。然後，對於我的後續行動，我只是快速了解 MRD 的（聽不清楚）更新，以及那裡的時間軸是怎樣的，以及其他研究環境中的接收情況如何？

Good question. So yes, we've outlined the forthcoming launch of tumor-naive MRD testing in colorectal that's sort of on track with what we had said previously. I think that the data looks really strong, not as good as tumor-informed as expected, but we feel really good about that. And we'll give you an update as that rolls out.

好問題。是的，我們已經概述了即將推出的結腸直腸腫瘤初治 MRD 檢測，這與我們之前所說的是一致的。我認為數據看起來確實強勁，雖然不如預期的腫瘤資訊那麼好，但我們對此感覺很好。我們將及時向您提供最新動態。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

This is Colleen on for Doug. We have a few questions first on your prenatal business. Can you give a bit of color on the over 40,000 tests sequentially on the split between NIPT and carrier screening Also, we haven't seen anything in the Green Journal table of content for May or June in terms of ACOG guidelines for microdeletions or carrier screening, should we assume that this might be coming in the late summer at the earliest? And can you remind us what the revenue and ASP impact would be if the (inaudible) guidelines are published?

我是科琳 (Colleen)，代替道格 (Doug)。我們首先想問幾個有關您產前事宜的問題。您能否就 NIPT 和攜帶者篩檢之間連續超過 40,000 次測試的劃分提供一些說明？此外，我們在 5 月或 6 月的《綠色期刊》目錄中沒有看到任何有關 ACOG 微缺失或攜帶者篩檢指南的內容，我們是否應該假設這可能最早在夏末出現？您能否提醒我們，如果發布（聽不清楚）指南，對收入和 ASP 的影響會是什麼？

Yes. That's great questions. So when you look at sort of the prenatal business, we usually see kind of consistent growth proportional to the size of the product portfolio within the women's health business.

是的。這些問題問得真好。因此，當您查看產前業務時，我們通常會看到與女性健康業務中的產品組合規模成比例的持續成長。

So NIPT is the number one product followed closely by carrier screening followed by the other products in the portfolio. So the growth kind of trajectory is sort of similar to what we see there. So we're screening NIPT both growing really nicely. And I mean 40,000 quarter-over-quarter is a really strong growth number. And I think that it's just a testament again to the strength of the technology, the continued execution by our team all the peer-reviewed data that we've published.

因此，NIPT 是排名第一的產品，緊隨其後的是攜帶者篩檢，然後是產品組合中的其他產品。因此，其成長軌跡與我們在那裡看到的有些相似。因此，我們正在篩選 NIPT，兩者都發展得非常好。我的意思是，季度環比增長 40,000 是一個非常強勁的成長數字。我認為這再次證明了這項技術的實力，以及我們團隊對所發布的所有同行評審數據的持續執行。

So that's off the back of in 2024, what was a really strong growth year where we had several hundred thousand units of growth even when you sort of exclude anything related to [Vita]. So women's health is growing really nicely.

所以這是在 2024 年之後，這是一個非常強勁的增長年，即使排除與[維塔]。因此，女性的健康狀況正在顯著改善。

With regards to the micro regulation guidelines and carrier screening guidelines, these are -- these are things that we believe are coming. We don't have any insight on the timing, but there have been some references recently in articles where they're talking about the forthcoming guidelines as sort of referencing them.

關於微觀監管指南和攜帶者篩檢指南，我們相信這些都是即將發生的事情。我們對時間安排沒有任何了解，但最近有一些文章提到即將出台的指導方針，就像是參考它們一樣。

So we think that's a positive sign. The other good news about them not being out yet is that they remain upside for us. So we're actually doing incredibly well as a business and we have this huge upside opportunity ahead of us built in on our core business. So I think that's sort of a positive. When you look at microdels we see a pretty high attachment rate I think we said previously, it's something like we're going to do something like 1 million 22q test this year or something in that range. And those aren't reimbursed, right?

所以我們認為這是一個正面的訊號。關於他們尚未出局的另一個好消息是，他們仍然對我們有利。因此，我們的業務實際上做得非常好，並且我們的核心業務中蘊藏著巨大的上升機會。所以我認為這是積極的。當您查看微德爾時，我們會看到相當高的附著率，我想我們之前說過，就像我們今年要做 100 萬次 22q 測試或在這個範圍內的測試一樣。這些都不能報銷，對嗎？

So they're built into our COGS they're built into the infrastructure and we're in today, there's a code in place that has a good ASP. We've contracted with payers for the test. It's just not reversed. So you can imagine if you flip on reimbursement, let's say, at $200 or $500 for 1 million on reimbursed tests a year, that's going to have a pretty significant impact. But of course, we'll have to see how that pans out.

因此，它們被建置到我們的 COGS 中，並被建置到基礎設施中，而我們今天已經擁有了具有良好 ASP 的程式碼。我們已經與測試付款人簽訂了合約。只是沒有逆轉而已。因此，你可以想像，如果你改變報銷方式，比如說，每年報銷 100 萬美元的測試費用為 200 美元或 500 美元，這將產生相當大的影響。但當然，我們必須看看結果如何。

I think the CPT code is priced on the CMS fee schedule around $700 and $50, something in that range. But of course, we're not putting that in our models but even at a few hundred dollars reimbursement, the upside could be very significant for us.

我認為 CPT 代碼在 CMS 費用表上的價格約為 700 美元和 50 美元，在這個範圍內。但當然，我們不會將其納入我們的模型中，但即使報銷金額只有幾百美元，對我們來說，其好處也可能非常顯著。

All right. And then just one quick follow-up on indication mix for Signatera. Is breast above 25% of total volume now? And is there anything you can share on how a potential increase in breast as a percentage of total value impacts to your payer mix, given breast cancer patients tend to be a bit younger than colorectal cancer, lung, et cetera. And relatedly, how have biomarker blinds impacted your no pay rate with commercial plans?

好的。然後只需對 Signatera 的適應症組合進行一次快速跟進。乳房現在是否佔總體積的 25% 以上？鑑於乳癌患者通常比結直腸癌、肺癌等癌症患者年輕一些，您能否分享一下乳癌在總價值中所佔百分比的潛在增長將如何影響您的付款人組合？與此相關的是，生物標誌物盲點如何影響您的商業計劃免費率？

Yes, those are good questions as well. I think breast, actually, we're doing really well. We're seeing -- I mean we generated a lot of data in breast cancer. The physicians are -- they really like our test, they like the performance of our test. We've got great genome data in breast cancer, so we're seeing a lot of excitement there. The DARE randomized study that's going to be reading out, that's obviously generating a lot of buzz, I-SPY data that we just announced today, plus what's coming at ASCO is generating a lot of buzz.

是的，這些也是很好的問題。我認為，實際上，我們在乳房方面做得很好。我們看到——我的意思是我們產生了大量有關乳癌的數據。醫生們——他們真的很喜歡我們的測試，他們喜歡我們測試的表現。我們獲得了大量有關乳癌的基因組數據，因此我們對此感到非常興奮。即將宣讀的 DARE 隨機研究顯然引起了很多關注，我們今天剛剛宣布的 I-SPY 數據以及 ASCO 即將公佈的數據也引起了很多關注。

So I think it's definitely one of the main tumor types. We don't see this sort of, I think, dynamic of maybe that burning the reimbursement or anything like that, it's actually like reimbursed very nicely with Natera given our current structure, and we think breast is a good opportunity. It's one of the main cancers and one of the ways we're going to help millions of patients as we move forward.

所以我認為它絕對是主要的腫瘤類型之一。我認為，我們不會見到這種可能燒掉報銷款或類似情況的動態，實際上，考慮到我們目前的結構，使用 Natera 進行報銷非常好，我們認為乳房是一個很好的機會。它是主要的癌症之一，也是我們未來幫助數百萬患者的方法之一。

The second question about biomarker. I think that's the bigger question is when are we going to start getting reimbursed from commercial plans. And really, what you're seeing largely today at the ASPs, Mike outlined around that $1,100 point, there's still a lot of upside in the commercial opportunity. And the biomarker states were starting to see some positive signs there. but there's a lot of opportunities. And we think, as we said, over time, the ASP for Signatera can be around $2,000, which is a significant increase from today.

第二個問題關於生物標誌物。我認為更大的問題是我們什麼時候才能開始從商業計劃中獲得報銷。事實上，今天在平均銷售價格 (ASP) 上看到的情況，Mike 概述了 1,100 美元左右的水平，商業機會仍有很大的上升空間。生物標誌狀態開始出現一些正面跡象。但還有很多機會。正如我們所說，我們認為，隨著時間的推移，Signatera 的平均銷售價格可能會達到 2,000 美元左右，這比現在有顯著的增長。

So when you look across, you look at women's health you look at oncology, revenue growth in the next five years is not just going to come from volume, right? It's going to come from significant improvements in ASP, from coverage wins and from turning on to commercial payers and from getting paid on the tumor types. And we think that's exciting because revenue growth is going to be accelerating above the level of volume growth.

所以，當你放眼整個領域，看看女性健康、看看腫瘤學，未來五年的收入成長不僅來自於數量，對嗎？它將來自 ASP 的顯著改善、來自覆蓋範圍的擴大、來自商業付款人的轉向以及根據腫瘤類型獲得報酬。我們認為這是令人興奮的，因為收入成長將高於銷售成長水準。

Catherine Schulte, Baird.

凱瑟琳舒爾特，貝爾德。

Maybe just first on Japan since you brought that up, getting your $2,000 segmenter ASP. Can you just remind us the time line and path forward there? And what kind of updates we could expect to hear this year on that topic?

既然您提到了這一點，那麼首先可能是在日本，您的分割器 ASP 為 2,000 美元。您能否提醒我們一下時間表和前進的道路？那麼今年我們能聽到哪些關於這個主題的最新消息呢？

Yes, that's great. Let me have Solomon take that for an update on Japan. Solomon?

是的，太棒了。讓我讓所羅門了解日本的最新情況。所羅門？

Yes. We're excited about the program in Japan, we are on track there. So it's been submitted to the regulatory authorities of the Japanese version of the FDA, it's called the PMDA. They're reviewing our application, our submissions if everything stays on track, we would expect that to be approved towards the end of the year, maybe as late as early next year. And that would trigger then the next submission to the health ministry for reimbursement, which happens sequentially.

是的。我們對日本的計畫感到非常興奮，我們的進展一切順利。因此它已提交給日本版 FDA 的監管機構，即 PMDA。他們正在審查我們的申請，如果一切順利的話，我們預計申請將在年底獲得批准，甚至可能在明年年初。這將觸發下一次向衛生部提交報銷申請，該申請將按順序進行。

That probably takes another six to nine months and brings us towards late next year when you start when we start expecting this to impact top line. And we know there's really significant demand for this technology in Japan.

這可能還需要六到九個月的時間，到明年年底我們才會開始預期這將對營收產生影響。我們知道日本對這項技術的需求確實很大。

As a reminder, there's approximately the same number of colorectal cancer diagnoses per year in Japan as there are in the United States despite there being a massive difference in overall population. And they're very eager to do biomarker-driven MRD guided treatment decisions.

需要提醒的是，儘管日本和美國的總體人口數量存在巨大差異，但每年診斷出結腸直腸癌的數量大致相同。他們非常渴望做出由生物標記驅動的 MRD 指導的治療決策。

So and it's already in the guidelines. MRD has already mentioned in the society guidelines in Japan as well. So we're looking forward to that. We're on track.

所以它已經在指南中了。MRD 在日本的社會指南中也被提及。所以我們對此充滿期待。我們正步入正軌。

Got it. And then maybe at this point in the launch for Signatera, I mean you guys are continuing to put up pretty incredible sequential volume growth. even with competitors coming out. We've got a new one entering the market now, about surveillance Medicare coverage and you guys still seem to be pretty dominant in where you are. So I guess, is there any change to how you go about that commercially in the current competitive landscape? Or maybe what are you hearing from customers around your value proposition?

知道了。然後也許在 Signatera 發布的這個階段，我的意思是你們正在繼續實現相當驚人的連續銷售成長。即使有競爭對手出現。現在，我們已經有一個新產品進入市場，涉及監控醫療保險，而你們似乎仍然在自己的領域佔據主導地位。所以我想，在目前的競爭環境下，你們在商業上的做法有什麼改變嗎？或者也許您從客戶那裡聽到了有關您的價值主張的什麼意見？

We're obviously pleased with our growth. There's been a lot of competitors that have been out for a long time, selling tests, very present doing early access programs talking to doctors. So we don't really think there's a change necessarily happening right now in the competitive environment. Certainly, there's been some larger companies that have gotten coverage maybe six to nine months ago that have been out there.

我們顯然對我們的成長感到滿意。已經有很多競爭對手在市場上存在了很長時間，銷售測試，並且非常積極地開展與醫生交談的早期訪問計劃。所以我們不認為目前的競爭環境必然會改變。當然，有些較大的公司大概在六到九個月前就已經獲得了保險。

We're just focusing on delivering and what we're seeing is that physicians really like the performance of our test. They like the clinical data that we've delivered. Now we have over 100 peer-reviewed publications, we have long-term overall survival data. We have data with physicians acting on the results of our test. And I think they put a lot of emphasis on that not necessarily some of the analytical validation studies that are easily manipulated or aren't necessarily -- we're not really able to kind of dig into the details as much.

我們只專注於交付，我們看到醫生們真的很喜歡我們的測試的表現。他們喜歡我們提供的臨床數據。現在我們有超過 100 篇同行評審的出版物，我們擁有長期整體生存數據。我們擁有醫生根據我們的測試結果採取行動的數據。我認為他們非常重視那些不一定容易被操縱或不一定是某些分析驗證研究的研究——我們實際上無法深入研究細節。

So we think we're doing very well. We're excited about what we're hearing from physicians about our product and the growth trajectory.

所以我們認為我們做得很好。我們很高興聽到醫生們對我們的產品和成長軌蹟的評價。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Question and congrats on another strong quarter. First one, on the women's health of business, the 40,000 units came in ahead of our expectations as well. And just trying to understand how are you lapping the (inaudible) comps there?

問題並祝賀您又一個強勁的季度。首先，關於女性健康業務，40,000 台的銷售量也超出了我們的預期。只是想了解一下您是如何在那裡重疊（聽不清楚）的？

Could you remind us how much of that -- how much of that growth was there in 2024 for (inaudible) and how does that comp affects your expectations for the year? And then, Mike, maybe on the ASP side, we're seeing payers -- commercial payers being under pressure. I was just wondering what sort of gives you the confidence that ASP remains flat to maybe just slightly up in that segment in women's health?

您能否提醒我們一下—2024 年的成長幅度是多少（聽不清楚）以及這種成長將如何影響您對今年的預期？然後，麥克，也許在 ASP 方面，我們看到付款人——商業付款人面臨壓力。我只是想知道是什麼讓您有信心在女性健康領域的平均售價保持平穩甚至略有上升？

Yes. Great. No, thanks for the question, Puneet. Yes, first, the volumes. We as you guys will remember, we took on the Invitae accounts really in Q1 of last year.

是的。偉大的。不，謝謝你的提問，Puneet。是的，首先是數量。你們會記得，我們​​去年第一季就開始接手 Invitae 帳號了。

So we've got almost a full year now of integrating the Invitae volumes into our business, and that was a very successful transaction for us. We're really pleased to be able to just kind of provide that continuity of care to a large swath of what were then new customers but now have been with us now for some time. So as you kind of go through the rest of the year, the comps are reasonably clean relative to relative to last year, and that's just kind of integrated in the volumes to the extent that it's a little bit hard to kind of separate out, hey, what was the [Vita] volume versus what was Natera volume at the time. So it just continues to kind of add to the platform.

因此，我們現在花了將近一年的時間將 Invitae 業務整合到我們的業務中，這對我們來說是一筆非常成功的交易。我們非常高興能夠為大量當時還是新客戶、但現在已經與我們合作了一段時間的客戶，提供持續的服務。因此，當你回顧今年剩餘的時間時，你會發現與去年相比，這些比較相當清晰，而且只是在某種程度上融入了銷量中，以至於很難區分，嘿，當時 [Vita] 的銷量是多少，Natera 的銷量是多少。所以它只是繼續在平台上添加內容。

The reason why deals like that in addition to volumes and like, for example, the growth we had in Q1 is so valuable to us is that we've got a fantastic operation to drive ASPs that we've really shown a lot of strong results on now over the last two years.

除了銷售量之外，諸如此類的交易以及我們在第一季取得的成長對我們如此有價值，是因為我們擁有出色的營運來推動平均售價，在過去兩年中，我們確實在這方面取得了許多強勁的成果。

So that team obviously scales perfectly with the volumes, they're happy to add $1 of ASP across a bigger and bigger base of Panorama volume, for example, I mean you get perfect synergies on that. That operation, Puneet, is what gives me the confidence that they guide you can actually kind of hold the results steady, through the rest of the year and feel good as a guide. That's not the commercial goal. That's not the goal that the team has internally.

因此，該團隊顯然可以完美地擴展銷量，例如，他們很樂意在越來越大的全景銷量基礎上增加 1 美元的 ASP，我的意思是，您可以獲得完美的協同效應。Puneet，這個操作讓我相信，他們能夠指導你在今年餘下的時間裡保持穩定的業績，並且作為一名指導者，你感覺很好。這不是商業目標。這不是球隊內部的目標。

I mean the internal team has a buildup of all kinds of situations where we've got coverage policies in place. These are standard of care tests and yet for one administrative reason or another, we're still not getting reimbursed as we should, and the team takes that personally. And that goes from Steve on down, and we work extremely hard to try and improve that situation.

我的意思是，內部團隊已經累積了各種情況，並制定了覆蓋政策。這些都是標準的護理測試，但由於這樣或那樣的行政原因，我們仍然沒有得到應有的報銷，團隊認為這是針對我們個人的。從史蒂夫開始，我們就一直堅持這樣做，我們非常努力地嘗試改善這種情況。

So I hear you that there will be some, there can be some pressures, and there have been, and that can come and go. But I think underlying that, I think we've got a good path to hopefully grow ASPs even as the guide holds steady for now.

所以我聽說會有一些壓力，可能會有一些壓力，而且一直都有，這些壓力可能會來來去去。但我認為，從根本上來說，即使指南目前保持穩定，我們也找到了一條有望提高 ASP 的良好途徑。

Okay. So that's great. And then on Signatera, maybe just a broader question. I just want to understand going forward, over the next 2 quarters and into 2026, could you elaborate sort of what are the critical drivers for strong growth? Is it NCCN? Is it getting deeper into the community setting? Is it getting into maybe other tier accounts beyond the Tier 1 and 2? Is it indication growth?

好的。這太棒了。然後關於 Signatera，也許只是一個更廣泛的問題。我只是想了解未來的情況，在接下來的兩個季度以及到 2026 年，您能否詳細說明強勁增長的關鍵驅動力是什麼？是NCCN嗎？它是否越來越深入社區環境？它是否會進入第 1 層和第 2 層之外的其他層級帳戶？這表示增長嗎？

Just maybe walk us through how you see the stack of drivers that are going to continue to drive this Signature growth because obviously, that's an important question every quarter for us and for investors.

請您向我們介紹一下，您認為有哪些驅動因素將繼續推動 Signature 的成長，因為顯然，這對我們和投資者來說都是每季的一個重要問題。

Yes. That's a good question. So I think, first, if you just start off with kind of the fundamentals, which is that this market is very, very -- at a very, very low level of penetration. And although there's a lot of excitement around the volume that we've done and the growth that we've had, we're still in the very low single digits when you look at the broader opportunity, which I think is important. And so the way that it works is -- like we said, we're already working with 45% of oncologists right now, 45% are actually ordering Signatera.

是的。這是個好問題。因此我認為，首先，如果你只是從基本面開始，那麼這個市場滲透率非常非常低。儘管我們對所完成的業務量和所取得的成長感到非常興奮，但從更廣泛的機會來看，我們的成長率仍然處於非常低的個位數，我認為這很重要。所以它的工作方式是——就像我們說的，我們現在已經與 45% 的腫瘤學家合作，其中 45% 的人實際上正在訂購 Signatera。

So it's not like 3% of oncologists are ordering Signature and we've got to go figure out how to get the other 97% to order. We already have half the oncologists in the country placing orders. Now as data comes out, as they get used to the test as they see the value in their practice, they start to order it on more patients within their practice. And I think that's really the main driver of growth, combined with bringing new NPIs and new physicians into the fold. So we focus on those two things.

因此，並不是只有 3% 的腫瘤學家訂購 Signature，而我們必須想辦法讓其他 97% 的腫瘤學家也訂購。我們已經有全國一半的腫瘤科醫生下了訂單。現在，隨著數據的公佈，他們也習慣了這種測試，因為他們看到了這種測試在實踐中的價值，他們開始在實踐中對更多的患者進行這種測試。我認為這確實是成長的主要動力，同時也引入了新的 NPI 和新的醫生。所以我們專注於這兩件事。

New doctors coming in that haven't used before or taking doctors that are using the product and showing them clinical data that allows them to use in other patients. And remember, the vast majority of physicians and volume is in the community setting. So it's not enough to just have one indication. I think if you come out and you have one indication reimbursed going to be very, very difficult to go to a community setting and say, hey, do you mind just carving off like this one particular subtype of patient and sending that to me, but we can't really do all the other stuff.

向以前沒有使用過該產品的新醫生或正在使用該產品的醫生展示臨床數據，以便他們將其用於其他患者。請記住，絕大多數醫生和診療量都集中在社區環境中。因此，僅有一個跡像是不夠的。我認為，如果你出來並且你有一個適應症需要報銷，那麼去社區環境說，嘿，你介意只分離出這種特定亞型的患者並將其發送給我，這將非常非常困難，但我們實際上不能做所有其他的事情。

So we're in this unique position where we have a pan cancer offering, we're broadly covered. We're connected into EMRs. We have a very large medical affairs team, a customer service team. They turn around time is very fast. And I think that puts us in a unique position. So we're generating as much data as we can. We think that drives utilization we're focusing on, obviously, the big cancer opportunities, but also not ignoring the smaller opportunities we're innovating.

因此，我們處於一個獨特的地位，我們提供全癌症治療服務，覆蓋範圍廣泛。我們已連接到 EMR。我們有一個非常龐大的醫療事務團隊和一個客戶服務團隊。他們週轉時間非常快。我認為這使我們處於獨特的地位。因此我們正在產生盡可能多的數據。我們認為，這推動了我們關注的利用率，顯然是巨大的癌症治療機會，但也不會忽略我們正在創新的較小機會。

As you can see, we've now launched the Signatera genome product. And there, we're getting down to one part per million -- we do see there are some physicians that are interested in that, although it's -- I think it's the vast majority of doctors are very pleased with the performance of the exome test, which itself gets down into the ultrasensitive range down to very low single-digit part per million. but there are some that want genome, and we're making that available to them.

如您所見，我們現在已經推出了Signatera基因組產品。現在，我們的精確度已經達到了百萬分之一——我們確實看到有些醫生對此感興趣，儘管——我認為絕大多數醫生對外顯子組測試的性能非常滿意，該測試本身已經進入了超靈敏範圍，精度達到了百萬分之一的非常低的個位數。但有些人想要基因組，我們會提供給他們。

So there's not really a reason at this point to use any of the competitive tests, and we think that puts us in a competitive position going forward to grow with the market. We're certainly investing a lot in clinical data, clinical research, and we think we're in an excellent position. Actually, we never felt stronger than we do right now about the growth trajectory of the business. And you can see right in the face of competitive launches where they're putting a lot of energy in.

因此，目前沒有理由使用任何競爭性測試，我們認為這將使我們在未來與市場共同成長的過程中處於競爭地位。我們確實在臨床數據和臨床研究方面投入了大量資金，我們認為我們處於非常有利的地位。事實上，我們從未像現在這樣強烈感受到業務的成長軌跡。您可以從競爭激烈的產品發布會上看到他們投入了大量的精力。

There's a lot of energy right now from competitors. We're putting up record numbers like we've never seen before. And I think that really speaks to the strength of our technology and the way physicians feel about our data and the way they feel about the performance of Signatera.

目前，競爭對手的活力非常大。我們正在創下前所未有的紀錄。我認為這確實說明了我們技術的實力以及醫生對我們的數據的感受以及他們對 Signatera 表現的感受。

Matt Sykes, Goldman Sachs.

高盛的馬特·賽克斯 (Matt Sykes)。

This is Will on for Matt. Just want to touch on the gross margin. It was really strong this quarter. Can you talk a little bit more about the COGS improvement initiatives and longer term, how much room is left for COGS reduction? Or is gross margin improvement largely going to come from the higher ASPs?

這是威爾取代馬特。只是想談談毛利率。本季表現確實強勁。您能否再多談 COGS 改善舉措以及長期來看 COGS 削減還有多少空間？或者毛利率的增加主要來自於更高的平均售價？

Yes. I comment on that briefly and then maybe, Mike, if you want to add something. So there's certainly room for COGS improvements. We do have a handful of larger-scale projects that are underway right now. A lot of the projects that we had announced previously, like building the tissue sequencing labs, those are largely completed, but there's still opportunity, and we're working on those opportunities now.

是的。我對此進行了簡要的評論，然後也許，邁克，如果你想補充一些內容。因此，COGS 肯定還有進步的空間。我們目前確實有一些較大規模的項目正在進行中。我們之前宣布的許多項目，例如建造組織定序實驗室，基本上已經完成了，但仍有機會，我們現在正在努力抓住這些機會。

There's also just COGS reductions that come with scale. A lot of -- if you look all across the workflows and just had the operations in general, as we continue to scale up, I think that provides some additional leverage which really helps us. But of course, there's huge upside opportunities on improving ASP and improving reimbursement.

隨著規模的擴大，COGS 也會減少。很多——如果你看一下整個工作流程，並且只是進行一般的操作，隨著我們繼續擴大規模，我認為這會提供一些額外的槓桿作用，這對我們真的很有幫助。但當然，提高 ASP 和改善報銷方面存在巨大的上昇機會。

And I can't emphasize that enough that when you look at the ASPs today, that really takes into account the fact that we -- there's a lot of tests where we're not getting coverage from insurance companies. And a lot of the investment that we've been making is to change that, and you are going to see that changing over the next five years that's where we're saying, look, we think we can effectively double the ASP of Signatera. We can really increase the women's health and organ health ASP going forward. which can drive significant revenue growth that can outpace volume growth.

我再怎麼強調也不為過，當你看今天的 ASP 時，這確實考慮到了這樣一個事實——我們有很多測試沒有得到保險公司的承保。我們所做的大量投資都是為了改變這種狀況，你將在未來五年內看到這種變化，這就是我們所說的，看，我們認為我們可以有效地將 Signatera 的平均銷售價格翻一番。我們可以真正提高女性健康和器官健康的 ASP。這可以推動收入大幅成長，且成長速度超過銷售成長。

That's helpful. And then maybe building on the last question, you launched the whole genome product this quarter. Just curious, any color on initial uptake and building on your previous comments. Longer term, how do you see the whole genome fitting into your portfolio?

這很有幫助。然後也許基於最後一個問題，您本季推出了全基因組產品。只是好奇，您對最初的理解和先前的評論有何看法？從長遠來看，您認為全基因組如何融入您的投資組合？

Yes. That's a good question. So we've launched the genome test. It's broadly available now. Pan cancer, we get down to one part per million. We are seeing some interest. But I think largely, physicians are really supportive of the peer review data that they've seen with the exome-based test where you have a lot of clinical outcomes.

是的。這是個好問題。因此我們啟動了基因組測試。現在它已廣泛可用。對於泛癌症，我們將其降低到百萬分之一。我們看到了一些興趣。但我認為，總體而言，醫生確實支持他們所看到的基於外顯子的測試的同行評審數據，因為在基於外顯子的測試中可以獲得很多臨床結果。

And one of the things that we're hearing from physicians is that some of these sort of extreme performance claims that are coming out of analytical studies, they're just not seeing that translate into improved clinical performance, and they're also raising concerns about specificity problems with some of the other genome-based laboratories.

我們從醫生那裡聽到的一件事是，一些來自分析研究的極端性能聲明並沒有轉化為臨床表現的改善，他們也對其他一些基於基因組的實驗室的特異性問題表示擔憂。

So we think we're in a good position. We have great performance on the exome. Doctors are telling us that they like the performance of the test. They like all the peer review data. They like the long-term data sets.

因此我們認為我們處於有利地位。我們在外顯子組方面表現優異。醫生告訴我們他們喜歡這項測試的效果。他們喜歡所有同行評審數據。他們喜歡長期數據集。

They're raising concerns about extreme analytical claims not necessarily translating into clinical performance, and they're raising concerns about specificity from some of the other companies.

他們擔心極端的分析主張不一定會轉化為臨床表現，他們對其他一些公司的特殊性也表示擔憂。

And we're seeing, as Solomon pointed out, in some cases, the competitors are actually not even disclosing their specificity. I think we saw that recently, a genome competitor that talked about their colorectal data. They actually didn't disclose their specificity. So that raises questions and doctors see that. So we think we're in a good position.

正如所羅門所指出的那樣，我們看到，在某些情況下，競爭對手實際上甚至沒有透露他們的具體特性。我想我們最近看到一個基因組競爭對手談論了他們的結直腸數據。他們實際上並沒有透露其具體細節。所以這引發了疑問，醫生也看到了這一點。因此我們認為我們處於有利地位。

Long term, we have both products in the doctor to look at the data and they can choose which test they want to go with.

從長遠來看，我們會同時使用這兩種產品，以便醫生可以查看數據，並可以選擇他們想要進行的測試。

That will conclude our question-and-answer session and our conference for today. Thank you all for joining. You may now disconnect.

我們今天的問答環節和會議到此結束。感謝大家的加入。您現在可以斷開連線。