Exelixis Inc (EXEL) 2025 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Exelixis' third quarter 2025 financial results conference call. My name is Cherie, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes.

各位女士、先生，大家好，歡迎參加 Exelixis 2025 年第三季財務業績電話會議。我叫謝麗，今天由我來為您接聽電話。再次提醒，本次通話將會被錄音，以便回放。

I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

現在，我謹將電話交給今天的主持人，公共事務和投資者關係執行副總裁蘇珊·哈伯德女士。請繼續。

Thank you, Cherie, and thank you all for joining us for the Exelixis' third quarter 2025 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; and Chris Senner, our Chief Financial Officer; Dana Aftab, our Executive Vice President of Research and Development; and P.J. Haley, our Executive Vice President of Commercial, who will review our progress for the third quarter 2025 ended October 3, 2025.

謝謝 Cherie，也謝謝各位參加 Exelixis 2025 年第三季財務業績電話會議。今天與我一同參加電話會議的有：我們的總裁兼執行長 Mike Morrissey；我們的財務長 Chris Senner；我們的研發執行副總裁 Dana Aftab；以及我們的商業執行副總裁 P.J. Haley，他們將回顧我們截至 2025 年 10 月 3 日的 2025 年第三季的進展。

During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results.

在今天的電話會議中，我們將提及一些並非依照公認會計原則計算的財務指標。請參閱我們網站上發布的今日新聞稿，了解我們使用這些非GAAP指標的原因，以及從我們的GAAP結果中得出這些指標的表格。

During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters, potential growth opportunities and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially.

在本次演講過程中，我們將對未來事件和公司的未來表現做出前瞻性陳述。這包括有關藥物發現、產品開發、監管、商業、財務和策略事項、潛在成長機會以及政府藥品定價政策和舉措等方面的可能進展的聲明。實際事件或結果當然可能與此有重大差異。

We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitations, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaborative partners, and the level of cost associated with discovery, product development, business development and commercialization activities.

我們建議您參閱我們不時向美國證券交易委員會提交的文件，這些文件在「風險因素」標題下列出了導致實際結果與公司今天以口頭和書面形式表達的結果存在重大差異的重要因素，包括但不限於與產品商業成功、市場競爭、監管審查和批准流程、進行臨床試驗、遵守適用的監管要求、我們對合作夥伴的依賴以及與發現、產品化的依賴以及與發現

And with that, I'll turn the call over to Mike.

接下來，我將把電話交給麥克。

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a strong third quarter, building on our progress from the first half of 2025. Accelerating R&D momentum coupled with flawless commercial execution has the potential to transform our business as we bring new treatment options to patients and build value for shareholders. The entire Exelixis team is committed to building a best-in-class, multi-franchise oncology business, and all corporate activities are aligned on a single focus to improve the standard of care for patients with cancer.

好的。謝謝蘇珊，也謝謝今天所有參加我們電話會議的各位。Exelixis 在第三季表現強勁，延續了 2025 年上半年的進展。加快研發步伐，加上完美的商業執行，有可能改變我們的業務，為患者帶來新的治療選擇，並為股東創造價值。Exelixis 的整個團隊致力於打造一流的多品牌腫瘤業務，所有公司活動都圍繞著一個共同的目標，即提高癌症患者的護理標準。

Our future success will be accelerated by increasing the number of cancer patients served with current and future Exelixis medicines and the impact we have on their disease. The cabozantinib business has never been stronger, and we're pleased to see zanzalintinib move to center stage with our first big clinical success in CRC. Key highlights for the third quarter include, first, continued robust performance of the cabozantinib US business with strong growth in demand and revenue from our commercial activities.

我們未來的成功將透過增加使用 Exelixis 目前和未來藥物治療的癌症患者人數以及我們對他們疾病的影響而加速實現。卡博替尼的業務從未如此強勁，我們很高興看到贊扎替尼憑藉我們在 CRC 領域取得的首個重大臨床成功而成為焦點。第三季的主要亮點包括：首先，卡博替尼美國業務持續強勁成長，商業活動的需求和收入均實現強勁成長。

Cabozantinib maintained its leadership position as the top TKI for RCC and importantly shows consistent growth in the first-line segment. US cabo franchise net product revenues grew approximately 14% year over year to $543 million in the third quarter 2025 compared to $478 million in the third quarter of 2024. Global cabo franchise and net product revenues generated by Exelixis and our partners were approximately $739 million in the third quarter of 2025 compared with $653 million in the third quarter of 2024.

卡博替尼保持了其作為 RCC 頂級 TKI 的領先地位，更重要的是，它在一線治療領域表現出持續成長。2025 年第三季度，美國 Cabo 特許經營淨產品收入年增約 14%，達到 5.43 億美元，而 2024 年第三季為 4.78 億美元。2025 年第三季度，Exelixis 及其合作夥伴產生的全球 cabo 特許經營和淨產品收入約為 7.39 億美元，而 2024 年第三季為 6.53 億美元。

We're excited by the broad adoption of cabo for the recently approved NET indications and have already built a leading position in the oral second-line plus net segment with a greater than 40% new patient share based on market research. Cabo demand in neuroendocrine tumors grew about 50% and contributed approximately 6% of our third quarter business. With this strong foundation, we expect to exceed $100 million in revenue for the NET indication in 2025.

我們很高興看到 cabo 在最近獲準的 NET 適應症中得到廣泛應用，並且根據市場調查，我們在口服二線加 NET 領域已經建立了領先地位，新患者份額超過 40%。Cabo 在神經內分泌腫瘤方面的需求增加了約 50%，並貢獻了我們第三季業務的約 6%。憑藉這一堅實的基礎，我們預計到 2025 年，NET 適應症的收入將超過 1 億美元。

Based on our early success in the NET launch, and with other GI opportunities on the horizon, we're expediting the full build-out of our GI sales team starting in fourth quarter 2025 to accelerate the growth of the cabo NET indication before zanza comes to the forefront. We think this enhancement could be an important component of our growth narrative in 2026 and speaks to the confidence we have in both cabo and zanza as we close out 2025. P.J. will provide more information and commentary about our third quarter franchise performance and encouraging dynamics of the net launch in his prepared remarks.

基於我們在 NET 上市初期的成功，以及其他胃腸道機會即將到來，我們將從 2025 年第四季度開始加快全面組建我們的胃腸道銷售團隊，以在 zanza 成為焦點之前加速 cabo NET 適應症的增長。我們認為，這項改進可能是我們 2026 年成長計畫的重要組成部分，也反映了我們在 2025 年即將結束之際對 cabo 和 zanza 的信心。P.J. 將在事先準備好的發言稿中提供更多關於我們第三季特許經營業績和令人鼓舞的淨啟動動態的資訊和評論。

Second, zanzalintinib is rapidly advancing as our next oncology franchise opportunity and the focus of seven ongoing and soon-to-start pivotal trials. We've continued to prioritize zanza with existing and new indications and combinations as potentially the most promising and expeditious path to a second Exelixis oncology franchise and one that we believe can eclipse the size, scope and impact of our cabozantinib business. Importantly, we're engaged in numerous clinical trial discussions for zanza that could expand the scope and reach of our zanza pivotal trial efforts.

其次，zanzalintinib 正在迅速發展成為我們下一個腫瘤特許經營機會，並且是七項正在進行和即將開始的關鍵性試驗的重點。我們一直將 Zanza 的現有和新適應症及組合療法列為優先事項，因為這可能是 Exelixis 第二個腫瘤產品線最有希望和最快的途徑，我們相信它能夠超越我們卡博替尼業務的規模、範圍和影響力。重要的是，我們正在就 zanza 進行多項臨床試驗討論，這可能會擴大我們 zanza 關鍵性試驗工作的範圍和影響力。

We're thrilled with the positive results for STELLAR-303 in CRC and intend to file in this indication with regulators as quickly as possible. We understand the nuances of the CRC market in the US and believe we can effectively navigate the intricacies of this complicated disease and the current competitive dynamics, pending approval.

我們對 STELLAR-303 在結直腸癌治療中取得的正面結果感到非常興奮，並打算盡快向監管機構提交該適應症的申請。我們了解美國 CRC 市場的細微差別，並相信在獲得批准之前，我們能夠有效地應對這種複雜疾病的複雜性和當前的競爭動態。

I'll remind everyone of the important messages from the full data set presented at ESMO and published simultaneously in Lancet. Zanza in combination with atezo was the first clinical success in a non-MSI-high, third-line-plus CRC population when compared against a contemporary standard of care. I want to reiterate that four other checkpoint-containing regimens failed to achieve this goal. Market research underscores that late-line CRC patients are interested in utilizing immune checkpoint inhibition to attack the disease head on, so the zanza-atezo combo could represent a meaningful advance.

我將提醒大家注意在 ESMO 會議上公佈並同時發表在《柳葉刀》上的完整資料集中的重要資訊。與當時的標準治療相比，Zanza 與 atezo 聯合治療在非 MSI 高、三線及以上 CRC 患者群體中取得了首個臨床成功。我想重申，其他四種含有檢查點的療法都未能實現這一目標。市場調查顯示，晚期 CRC 患者對利用免疫檢查點抑制劑正面攻擊疾病很感興趣，因此 zanza-atezo 組合可能代表著一項意義重大的進展。

The absolute magnitude of the overall survival benefit in the ITT population with the zanza-atezo combination is notable, especially in the context of the offering of the potential of a non-chemo-containing regimen. We're especially pleased with the magnitude of benefit in patients with prior bevacizumab treatment, since the vast majority of CRC patients in the US received bevacizumab as part of their first- and/or second-line treatment regimens. Tolerability and safety of the zanza-atezo combination is consistent with other TKI checkpoint combinations.

在 ITT 族群中，zanza-atezo 聯合療法帶來的總生存獲益的絕對幅度是顯著的，尤其是在有可能提供不含化療的治療方案的背景下。我們尤其對先前接受過貝伐單抗治療的患者所獲得的顯著益處感到高興，因為美國絕大多數 CRC 患者都曾接受過貝伐單抗作為其一線和/或二線治療方案的一部分。zanza-atezo 組合的耐受性和安全性與其他 TKI 檢查點組合一致。

The 303 trial continues to accrue survival events in the non-liver met subgroup, and we expect to trigger the final analysis for non-liver met patients in midyear 2026. And again, as you'll hear from Dana, seven ongoing and new zanza pivotal trials are in the queue to address important unmet medical needs for known and new indications across multiple lines of therapy.

303 試驗繼續在非肝轉移亞群中累積存活事件，我們預計將於 2026 年年中啟動非肝轉移患者的最終分析。此外，正如您將從 Dana 那裡聽到的那樣，目前有七項正在進行和新的 Zanza 關鍵性試驗正在排隊等待，以解決已知和新適應症在多個治療領域中的重要未滿足的醫療需求。

The Exelixis early-stage pipeline continues to progress quickly with a range of new and potentially differentiated biologics and small molecules heading into and through early clinical evaluation. Dana will highlight these activities today at a high level, and you can expect additional details on these efforts along with our zanza pivotal trial update at our upcoming R&D Day on December 10.

Exelixis 的早期研發管線持續快速推進，一系列新的、具有潛在差異化的生物製劑和小分子藥物正在進入和完成早期臨床評估。Dana 將於今天重點介紹這些活動，您可以在 12 月 10 日即將舉行的研發日上獲得有關這些工作的更多詳細資訊以及我們 zanza 關鍵性試驗的最新進展。

Finally, we continue to carefully manage capital allocation while advancing our R&D and commercial priorities. Our balance sheet and expected free cash flows remain strong and provide us with the opportunity to advance our pipeline priorities while we return cash to shareholders.

最後，我們將繼續謹慎管理資本配置，同時推動我們的研發和商業化重點。我們的資產負債表和預期自由現金流依然強勁，這為我們提供了推進專案優先事項的機會，同時我們也向股東返還現金。

We plan to repurchase shares when we believe they are undervalued, and we're pleased that we have been authorized to repurchase an additional $750 million of our shares. So with that, please see our press release issued an hour ago for our third-quarter 2025 financial results and an extensive list of key corporate milestones achieved in the quarter.

我們計劃在認為股票被低估時回購股票，我們很高興獲準額外回購價值 7.5 億美元的股票。因此，請參閱我們一小時前發布的新聞稿，以了解我們 2025 年第三季的財務業績以及本季取得的關鍵公司里程碑的詳細清單。

And I'll now turn the call over to Chris.

現在我將把電話交給克里斯。

Thanks, Mike. For the third quarter of 2025, the company reported total revenues of approximately $598 million, which included cabozantinib franchise net product revenues of approximately $543 million. CABOMETYX net product revenues were approximately $540 million. Gross-to-net for the cabozantinib franchise in the third quarter 2025 was 30.4%. During the quarter, we experienced higher deductions from revenue related to 340B discounts offset by lower Medicare and co-pay assistance expenses.

謝謝你，麥克。2025 年第三季度，該公司報告總收入約 5.98 億美元，其中包括卡博替尼特許經營淨產品收入約 5.43 億美元。CABOMETYX 的淨產品收入約為 5.4 億美元。2025 年第三季卡博替尼特許經營權的毛利達到 30.4%。本季度，由於 340B 折扣，我們的收入減少了，但醫療保險和共同支付援助支出減少，抵消了部分收入損失。

We continue to project that our gross-to-net for the cabozantinib franchise will be approximately 30% for the year. Trade inventory at the end of the third quarter 2025 was approximately two weeks on hand, which was lower when compared to the second quarter of 2025. Total revenues also included approximately $54.8 million in collaboration revenues, which includes approximately $46.3 million in royalties earned from our partners Ipsen and Takeda on their sales of cabozantinib in their respective territories.

我們持續預測，卡博替尼產品線的毛利率今年將達到約 30%。2025 年第三季末的貿易庫存大約相當於兩週的供應量，比 2025 年第二季末有所下降。總收入還包括約 5,480 萬美元的合作收入，其中包括從合作夥伴 Ipsen 和 Takeda 在其各自區域銷售卡博替尼中獲得的約 4,630 萬美元特許權使用費。

Our total operating expenses for the third quarter of 2025 were approximately $361 million compared to $355 million in the second quarter of 2025. The sequential increase in these operating expenses was primarily driven by a $19.8 million restructuring charge we took during the third quarter. The increase in restructuring expense was partially offset by lower SG&A expenses. Provision for income taxes for the third quarter of 2025 was approximately $58.8 million compared to a provision for income taxes of approximately $45.6 million for the second quarter of 2025.

2025 年第三季我們的總營運支出約為 3.61 億美元，而 2025 年第二季為 3.55 億美元。這些營運費用的季增主要是由於我們在第三季提列了 1,980 萬美元的重組費用。重組費用的增加被銷售、一般及行政費用的降低部分抵銷。2025 年第三季所得稅準備金約為 5,880 萬美元，而 2025 年第二季所得稅準備金約為 4,560 萬美元。

The company reported GAAP net income of approximately $193.6 million or $0.72 per share basic and $0.69 per share diluted for the third quarter of 2025. The company also reported non-GAAP net income of approximately $217.9 million or $0.81 per share basic and $0.78 per share diluted. Non-GAAP net income excludes the impact of approximately $24 million of stock-based compensation expense net of related income tax effect. Cash and marketable securities for the quarter ended September 30, 2025 were approximately $1.6 billion.

該公司公佈 2025 年第三季 GAAP 淨收入約為 1.936 億美元，即每股基本收益 0.72 美元，每股攤薄收益為 0.69 美元。該公司也公佈了非GAAP淨利潤約為2.179億美元，即每股基本收益0.81美元，每股攤薄收益0.78美元。非GAAP淨收入不包括約2,400萬美元的股票選擇權費用（扣除相關所得稅影響）。截至 2025 年 9 月 30 日止季度，現金及有價證券約 16 億美元。

During the third quarter of 2025, we repurchased approximately $99 million of the company's shares, resulting in the retirement of approximately 2.4 million shares at an average price per share of $41.69. As of the end of the third quarter 2025, we had approximately $105 million remaining under the $500 million stock repurchase plan authorized by the company's Board in February 2025. On October 31, 2025, the company's Board authorized an additional share repurchase program totaling $750 million that expires at the end of 2026.

2025年第三季度，我們回購了該公司約9,900萬美元的股票，相當於註銷了約240萬股，平均每股價格為41.69美元。截至2025年第三季末，根據公司董事會於2025年2月批准的5億美元股票回購計劃，我們還有約1.05億美元剩餘資金。2025 年 10 月 31 日，公司董事會批准了一項總額為 7.5 億美元的額外股票回購計劃，該計劃將於 2026 年底到期。

We are updating our full year 2025 financial guidance, which is detailed on slide 14 of our earnings presentation. We are narrowing our total revenue and net product revenue guidance to the upper end of our previously provided guidance ranges. We are projecting that total revenue will be between $2.3 billion and $2.35 billion, and our net product revenue will be between $2.1 billion and $2.15 billion.

我們正在更新 2025 年全年財務預期，詳情請見收益簡報第 14 頁。我們將總收入和淨產品收入預期範圍縮小至先前提供的預期範圍的上限。我們預計總收入將在 23 億美元至 23.5 億美元之間，淨產品收入將在 21 億美元至 21.5 億美元之間。

We are tightening our cost of goods guidance to be approximately 4% of net product revenues. We are lowering our R&D expense guidance range by $75 million to $850 million to $900 million. We are tightening our SG&A expense guidance range to be between $500 million and $525 million. And finally, we are lowering our full year effective tax rate guidance to be between 17% and 18%.

我們將商品成本預期收緊至淨產品收入的約 4%。我們將研發費用預期範圍調降 7,500 萬美元至 8.5 億美元至 9 億美元。我們將銷售、一般及行政費用指引收緊至 5 億美元至 5.25 億美元之間。最後，我們將全年實際稅率預期下調至 17% 至 18% 之間。

With that, I'll turn the call over to Dana.

這樣，我就把電話交給達娜了。

Thanks, Chris. First, I'd like to start by saying how excited I am to be leading the R&D organization. The energy and engagement across R&D is super high right now, and the momentum that carried us into and through ESMO is continuing to drive our teams with an emphasis on execution and collaboration. Our focus in R&D is on maximizing the opportunities for our portfolio, including zanzalintinib and our earlier-stage pipeline of promising small molecules and biotherapeutics.

謝謝你，克里斯。首先，我想表達我對領導研發部門的無比激動之情。目前研發部門的活力和參與度都非常高，我們進入和參加 ESMO 的這股勢頭繼續激勵著我們的團隊，專注於執行和協作。我們在研發方面的重點是最大限度地利用我們的產品組合的機會，包括 zanzalintinib 以及我們早期階段的有前景的小分子和生物療法產品線。

As I mentioned, we have a lot of momentum coming out of ESMO, primarily driven by our presentation of the results from the STELLAR-303 trial, comparing the combination of zanzalintinib plus atezolizumab versus regorafenib in patients with non-microsatellite instability high or non-MSI-high colorectal cancer who have received multiple prior therapies.

正如我之前提到的，我們在 ESMO 大會上取得了很大的進展，這主要得益於我們公佈了 STELLAR-303 試驗的結果。該試驗比較了 zanzalintinib 加 atezolizumab 與 regorafenib 聯合治療非微衛星不穩定性高 (MSI-H) 或非 MSI-H 結直腸癌且既往接受過多種治療的患者的效果。

As a brief reminder, the trial has dual primary endpoints designed to assess survival outcomes more broadly in the intention-to-treat or ITT population and more specifically in the population of patients without liver metastases, which we refer to as the NLM patients or population. The study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the ITT population at the final analysis with a stratified hazard ratio of 0.80, a 95% confidence interval of 0.69 to 0.93 and a p-value of 0.0045.

簡單回顧一下，該試驗有兩個主要終點，旨在更廣泛地評估意向治療 (ITT) 人群的生存結果，以及更具體地評估無肝轉移患者人群（我們稱之為 NLM 患者或人群）的生存結果。該研究達到了其雙重主要終點之一，在最終分析中，ITT 族群的聯合治療使死亡風險降低了 20%，分層風險比為 0.80，95% 置信區間為 0.69 至 0.93，p 值為 0.0045。

At a median follow-up of 18 months, the median overall survival in the ITT population was 10.9 months with the combination of zanza plus atezo versus 9.4 months with rego. The survival benefit with the combination was demonstrated early and was consistent throughout the Kaplan-Meier curve. The overall survival benefit with the zanza plus atezo combination was observed across all pre-specified subgroups with similar hazard ratios observed in key subgroups, including liver involvement, prior treatment with anti-VEGF therapy, geographic region and RAS mutation status.

中位追蹤時間為 18 個月，ITT 族群中，zanza 合併 atezo 治療組的中位總存活期為 10.9 個月，而 rego 治療組的中位總存活期為 9.4 個月。聯合治療的生存獲益在早期就已顯現，並且在整個 Kaplan-Meier 生存曲線中保持一致。在所有預先設定的亞群中，Zanza 加 Atzo 聯合治療均觀察到整體存活獲益，在關鍵亞群中觀察到相似的風險比，包括肝臟受累、先前接受抗 VEGF 治療、地理區域和 RAS 突變狀態。

Data pertaining to the other dual primary endpoint of overall survival in the NLM population were immature at the data cutoff, but a prespecified interim analysis showed a trend in overall survival favoring the zanza plus atezo combination with a median of 15.9 months with the combination and 12.7 months with rego.

在數據截止時，與 NLM 族群中總存活期這一雙重主要終點相關的數據尚不成熟，但預先設定的中期分析顯示，總生存期有趨勢有利於 zanza 加 atezo 聯合治療，聯合治療組的中位生存期為 15.9 個月，而 rego 組為 12.7 個月。

With a median follow-up of 16.8 months, the stratified hazard ratio for this analysis was 0.79 with a 95% confidence interval of 0.61 to 1.03 and a p-value of 0.0875. The trial will proceed to the planned final analysis for this endpoint, which our current projections indicate will be triggered around midyear 2026.

中位追蹤時間為 16.8 個月，此分析的分層風險比為 0.79，95% 信賴區間為 0.61 至 1.03，p 值為 0.0875。該試驗將繼續進行該終點的計畫最終分析，根據我們目前的預測，該分析將於 2026 年年中左右啟動。

The safety profile of the combination was consistent with other TKI/IO combinations with no new safety signals. And finally, we were thrilled to have the trial results published in the Lancet simultaneously with the ESMO presentation. Needless to say, we are very excited about these results, which are highly impactful for a number of reasons.

此組合的安全性與其他 TKI/IO 組合一致，沒有出現新的安全訊號。最後，我們非常高興地看到試驗結果與 ESMO 報告同時發表在《柳葉刀》上。毋庸置疑，我們對這些結果感到非常興奮，這些結果在許多方面都具有重大影響。

First, prior to the STELLAR-303 readout, there were four Phase III clinical trials in colorectal cancer that evaluated immunotherapy-containing regimens, all of which failed to show an overall survival benefit versus the standard of care in non-MSI-high patients, which comprise 95% of the overall colorectal cancer population. As the first and only Phase III trial to show an overall survival benefit compared to a standard of care in these patients, we believe STELLAR-303 demonstrates clear clinical differentiation of zanza from other TKIs and IO partners investigated in this space.

首先，在 STELLAR-303 公佈結果之前，有四項針對結直腸癌的 III 期臨床試驗評估了含免疫療法的方案，但所有這些試驗均未能顯示非 MSI 高患者的總生存期優於標準治療方案，而這類患者佔結直腸癌患者總數的 95%。作為首個也是唯一一個顯示與標準治療相比，該療法能使患者整體生存獲益的 III 期試驗，我們相信 STELLAR-303 證明了 zanza 與該領域研究的其他 TKI 和 IO 夥伴藥物之間存在明顯的臨床差異。

As a reminder, in addition to VEGF receptors, zanza simultaneously targets the TAM kinases and MET, which have been shown in preclinical models to drive the ability of tumors to evade antitumor immunity. We believe this differentiated mechanism of action is a key factor in the clinical differentiation of zanza compared to other kinase inhibitors investigated in this space and really underscores the franchise potential for zanza.

需要提醒的是，除了 VEGF 受體外，zanza 也同時靶向 TAM 激酶和 MET，臨床前模型已證明，這些激酶和 MET 能夠驅動腫瘤逃避抗腫瘤免疫的能力。我們認為，這種差異化的作用機制是 Zanza 與其他在該領域研究的激酶抑制劑在臨床上區分開來的關鍵因素，並且真正突顯了 Zanza 的特許經營潛力。

Second, it's certainly worth noting that to date no other regimen has demonstrated a higher median overall survival in this setting. Again, in STELLAR-303, the combination of zanza plus atezo showed median overall survival values of 10.9 months in the ITT population and 10.5 months in patients who had received prior bevacizumab.

其次，值得注意的是，迄今為止，還沒有其他治療方案在此類情況下顯示出更高的中位總生存期。同樣，在 STELLAR-303 試驗中，zanza 加 atezo 的聯合治療在 ITT 人群中顯示中位總生存期為 10.9 個月，在先前接受過貝伐珠單抗治療的患者中顯示中位總生存期為 10.5 個月。

And while we are conscious of the caveats associated with cross-trial comparisons, it's relative to observe that prior to STELLAR-303, the SUNLIGHT trial showed median overall survivals for TAS-102 plus bev of 10.8 months in the ITT population and only 9.0 months in the bev pre-treated population. We believe these are important data points to note, given that the majority of patients in the US are receiving bev in earlier lines of treatment.

雖然我們意識到跨試驗比較存在一些注意事項，但值得注意的是，在 STELLAR-303 試驗之前，SUNLIGHT 試驗顯示，在 ITT 人群中，TAS-102 加貝伐珠單抗治療的中位總生存期為 10.8 個月，而在貝伐珠單抗預處理人群中僅為 9.0 個月。我們認為這些數據點非常重要，因為美國的大多數患者在早期治療中都接受了貝伐珠單抗治療。

And last but not least, being an immunotherapy-containing, chemo-free regimen, if approved, zanza in combination with atezo could be an opportunity to switch mechanisms to a TKI/IO regimen after receiving chemo plus bev, which we have heard from investigators and key opinion leaders is an important potential choice for patients. Thus, we certainly believe that the combination of zanza plus atezo has the potential for a very meaningful impact in this high unmet need population.

最後但同樣重要的是，如果獲得批准，zanza 與 atezo 聯合使用是一種含有免疫療法、不含化療的方案，這可能為接受過化療加 bev 治療的患者提供一個將治療機制轉換為 TKI/IO 方案的機會。我們從研究人員和關鍵意見領袖那裡了解到，這對患者來說是一個重要的潛在選擇。因此，我們堅信，zanza 加 atezo 的組合療法有可能對這個高度未滿足需求的群體產生非常有意義的影響。

That conviction has been driving our internal teams to work nonstop preparing for a potential NDA filing, which we intend to submit this December, pending the government reopening for business. We also intend to complete data collection and analysis for the dual primary endpoint of overall survival in the NLM population, which we anticipate will occur around midyear 2026.

正是這種信念驅使我們的內部團隊不停地工作，為可能提交的保密協議申請做準備，我們計劃在今年 12 月提交，前提是政府重新開放商業活動。我們還計劃完成 NLM 族群總生存期這一雙重主要終點的數據收集和分析，預計將在 2026 年年中左右完成。

Moving on to STELLAR-304, this is our pivotal study evaluating the combination of zanza plus nivolumab versus sunitinib in patients who have not yet received systemic therapy for their locally advanced or metastatic non-clear cell renal cell carcinoma. Based on the current event rate, we are anticipating top-line results around midyear 2026. And if positive, those results could lead to the second NDA filing for zanzalintinib.

接下來是 STELLAR-304，這是我們的關鍵性研究，旨在評估 zanza 加 nivolumab 與舒尼替尼聯合治療尚未接受全身治療的局部晚期或轉移性非透明細胞腎細胞癌患者的療效。根據目前的事件發生率，我們預計在 2026 年年中左右會公佈主要結果。如果結果呈陽性，則可能導致 zanzalintinib 的第二次新藥申請。

Regarding other clinical development activity for zanza, earlier this year, we initiated STELLAR-311, our Phase III trial evaluating zanza compared to everolimus as a first oral therapy in patients with neuroendocrine tumors, and that study is proceeding on schedule.

關於 zanza 的其他臨床開發活動，今年早些時候，我們啟動了 STELLAR-311，這是一項 III 期試驗，旨在評估 zanza 與依維莫司作為神經內分泌腫瘤患者的一線口服療法的比較，該研究正在按計劃進行。

Progress also continues with regard to the Phase II umbrella study being conducted by Merck in which the combination of zanza plus belzutifan is being evaluated in patients with previously treated metastatic RCC and two pivotal studies that Merck is running in clear cell renal cell carcinoma, evaluating zanza in combination with belz. And we anticipate these studies could start near the end of this year.

默克公司正在進行的 II 期傘式研究也取得了進展，該研究評估了 zanza 加 belzutifan 聯合用藥對既往接受過治療的轉移性腎細胞癌患者的療效；此外，默克公司還在透明細胞腎細胞癌領域開展了兩項關鍵研究，評估 zanza 與 belz 聯合用藥的療效。我們預計這些研究可能會在今年年底左右開始。

Regarding the next wave of pivotal studies for zanza, we expect to start two additional trials in 2026, one focused on patients with recurrent meningioma and one specifically investigating the adjuvant setting in colorectal cancer, where patients have been treated with surgery and chemotherapy but have a high risk of recurrence.

關於 Zanza 的下一階段關鍵研究，我們預計將於 2026 年啟動兩項額外的試驗，一項針對復發性腦膜瘤患者，另一項專門研究結直腸癌的輔助治療，這些患者已經接受過手術和化療，但復發風險很高。

Given the demonstrated clinical differentiation we've seen with zanza and its potential to be the TKI of choice for combinations with IO, we're continuing to assess the landscape for additional opportunities for zanza development, and we look forward to sharing more details of these important opportunities as we get closer to launching the trials.

鑑於 Zanza 已展現出的臨床差異化優勢，以及它作為 TKI 與 IO 聯合治療的首選藥物的潛力，我們正在繼續評估 Zanza 開發的其他機會，並期待在試驗啟動前分享這些重要機會的更多細節。

Now shifting to our early clinical pipeline, we have four molecules in this space that are currently in clinical development, namely XL309, XB010, XB628 and XB371. And the Phase I studies for these early molecules are progressing well. In terms of new development candidates, we are continuing to advance exciting new small molecule and ADC programs, and I look forward to sharing more details about our early pipeline programs at the R&D Day event we're planning for December 10 this year.

現在轉向我們的早期臨床研發管線，我們目前在這個領域有四種分子正在進行臨床開發，分別是 XL309、XB010、XB628 和 XB371。這些早期分子的 I 期研究進展順利。在新藥研發方面，我們正在繼續推進令人興奮的新小分子和抗體藥物偶聯物 (ADC) 項目，我期待在今年 12 月 10 日舉行的研發日活動上分享更多關於我們早期研發管線項目的細節。

So with that, I'll turn the call over to P.J.

那麼，接下來我將把電話交給 P.J.。

Thank you, Dana. The CABOMETYX business remained strong in the third quarter of 2025. And importantly, the launch in neuroendocrine tumors is off to a great start. Cabo continued to show growth in terms of revenue, demand and new patient starts and notably performed well relative to the competition.

謝謝你，達娜。CABOMETYX 業務在 2025 年第三季依然保持強勁勢頭。更重要的是，神經內分泌腫瘤領域的研究取得了良好的開端。Cabo在收入、需求和新患者數量方面持續成長，並且相對於競爭對手而言表現尤為出色。

The team continued to execute at an extremely high level with CABOMETYX continuing to be the number one prescribed TKI in renal cell carcinoma as well as the number one TKI plus IO combination in first-line RCC. The prescription data in the oral TKI market basket of cabo, lenvatinib, axitinib, sunitinib and pazopanib convey the strength of cabo relative to the competition.

團隊繼續保持極高的執行力，CABOMETYX 繼續成為腎細胞癌中處方量最高的 TKI，也是第一線 RCC 中 TKI 加 IO 聯合療法中處方量最高的藥物。口服 TKI 市場籃子中的處方數據（包括卡波西丁、樂伐替尼、阿昔替尼、舒尼替尼和帕唑帕尼）反映了卡波西丁相對於競爭對手的優勢。

Looking at the TRx comparison of Q3 2024 to Q3 2025, CABOMETYX grew four share points from 42% to 46%. Importantly, CABOMETYX was the only product in the market basket to grow market share year over year. CABOMETYX TRx volume grew 21% in Q3 2025 relative to Q3 2024, outpacing the growth rate of the market basket, which was 13%.

從 2024 年第三季到 2025 年第三季的 TRx 比較來看，CABOMETYX 的市佔率成長了 4 個百分點，從 42% 成長到 46%。值得注意的是，CABOMETYX 是市場產品組合中唯一一款市佔率逐年成長的產品。CABOMETYX TRx 交易量在 2025 年第三季比 2024 年第三季成長了 21%，超過了市場籃子 13% 的成長率。

Importantly, CABOMETYX RCC business remains strong and continues to grow. The new indications for previously treated NETs are providing our experienced sales team great access to customers, and we're able to discuss both the CABINET data as well as the RCC CheckMate-9ER five-year follow-up data with relevant physicians. The 9ER data presented at ASCO GU in February resonate with RCC space and help our team continue to drive differentiation from the competition in first-line RCC.

重要的是，CABOMETYX RCC 業務仍然強勁，並且持續成長。對於先前接受過治療的 NET 的新適應症，我們經驗豐富的銷售團隊能夠更好地接觸客戶，並且能夠與相關醫生討論 CABINET 數據以及 RCC CheckMate-9ER 五年隨訪數據。2 月在 ASCO GU 上公佈的 9ER 數據與 RCC 領域產生了共鳴，並幫助我們的團隊繼續在 RCC 一線治療領域實現與競爭對手的差異化。

In fact, CABOMETYX plus nivolumab first-line new patient market share in the third quarter was the highest it has ever been. This momentum bodes well for future growth in terms of new patient starts and total demand as more first-line patients receive incremental refills and volume as we look forward into 2026.

事實上，CABOMETYX 聯合 nivolumab 第一線新病患治療方案在第三季的市佔率達到了歷史最高水準。展望 2026 年，隨著更多第一線患者獲得遞增的續藥量和用藥量，這一勢頭預示著未來新患者數量和總需求將實現良好增長。

Turning to neuroendocrine tumors, our market research and feedback from customers demonstrate that prescribers are excited for a new treatment option for their neuroendocrine tumor patients, the first broadly applicable new oral small molecule therapy in nine years. Physicians are responding positively to the broad NET label and the contemporary trial design and perceive the efficacy and tolerability of the cabo data as favorable relative to the other small molecule therapies in the space.

就神經內分泌腫瘤而言，我們的市場研究和客戶反饋表明，處方醫生對神經內分泌腫瘤患者的新治療選擇感到興奮，這是九年來第一個廣泛適用的新型口服小分子療法。醫生們對廣泛的 NET 標籤和現代試驗設計給予了積極的回應，並認為與該領域的其他小分子療法相比，cabo 數據的療效和耐受性是有利的。

Prescribers are using cabo broadly across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas, GI tract and lung across all tumor grades, functional and SSTR status and those who have received prior treatment with Lutathera. The recent ESMO presentation of the lung subset data from the CABINET study continues to elucidate the cabo data in a segment of patients accounting for approximately 20% of NET who have a high unmet need, many of which test SSTR negative.

處方醫生正在廣泛使用卡博替尼治療各種患者和腫瘤特徵，包括所有腫瘤等級、功能和 SSTR 狀態的胰臟、胃腸道和肺部神經內分泌腫瘤患者，以及先前接受過 Lutathera 治療的患者。ESMO 最近公佈了 CABINET 研究的肺部亞組數據，繼續闡明了 CABINET 研究在約佔 NET 患者 20% 的患者群體中，存在高度未滿足需求的 CABINET 數據，其中許多患者的 SSTR 檢測結果為陰性。

Turning to new patient market share for second-line plus neuroendocrine tumors in Q3, we are pleased that CABOMETYX has rapidly become the market leader in this segment with greater than 40% new patient share for oral therapies. This share is very encouraging so early in the launch, and we believe that new patient share should continue to increase.

第三季度，在第二線及以上神經內分泌腫瘤的新患者市場份額方面，我們很高興看到 CABOMETYX 已迅速成為該領域的市場領導者，口服療法的新患者份額超過 40%。在產品上市初期就取得這樣的成績非常令人鼓舞，我們相信新病患份額應該會繼續成長。

Over time, as more patients start therapy with cabo and receive refills, we believe demand will continue to grow. Neuroendocrine tumor demand contributed approximately 6% of total demand for cabo in Q3, and we expect that contribution to increase going forward. Demand in neuroendocrine tumors increased by over 50% in Q3 relative to Q2.

隨著越來越多的患者開始接受卡波西氏肉瘤治療並獲得續藥，我們相信需求將會持續成長。第三季度，神經內分泌腫瘤對卡波西氏肉瘤的需求約佔總需求的 6%，我們預期未來這一比例還會上升。第三季神經內分泌腫瘤的需求量比第二季度增加了 50% 以上。

Finally, market research continues to indicate that CABOMETYX is viewed as the best-in-class oral therapy in neuroendocrine tumors. This perception is typically a leading indicator of prescribing behavior and gives us confidence that CABOMETYX new patient market share will continue to increase in coming quarters. This research finding aligns well with the anecdotal feedback our experienced sales team is receiving from their customers, many of whom are saying they will prescribe cabo for their NET patients once they progress and need a different systemic therapy.

最後，市場調查繼續表明，CABOMETYX 被認為是治療神經內分泌腫瘤的一流口服療法。這種看法通常是處方行為的領先指標，讓我們有信心 CABOMETYX 的新患者市佔率將在未來幾季繼續成長。這項研究結果與我們經驗豐富的銷售團隊從客戶那裡收到的軼事回饋非常吻合，許多客戶表示，一旦 NET 患者病情進展並需要不同的全身治療，他們將為患者開立卡波西肉瘤處方。

Taken together, the data and customer feedback give us a high degree of confidence in the growth of CABOMETYX in neuroendocrine tumors. If we look at the cabo neuroendocrine tumor business, the revenue for 2025 is vectoring towards exceeding $100 million. This trajectory, taken together with the market uptake and enthusiasm, provides great momentum for the business heading into 2026.

綜合數據和客戶回饋，我們對 CABOMETYX 在神經內分泌腫瘤中的成長充滿信心。如果我們觀察一下卡波神經內分泌腫瘤業務，2025 年的收入預計將超過 1 億美元。這一發展軌跡，加上市場的接受度和熱情，為公司邁向 2026 年提供了巨大的發展動力。

As we think about building on and expanding our GI franchise, we are thrilled with the results of STELLAR-303. Pending regulatory approval, we believe that these data will provide Exelixis with a compelling commercial opportunity in colorectal cancer, one of the big four tumors. Many physicians cite the availability of an immune checkpoint inhibitor for a broader population is important for their patients. They also view zanza as differentiated given the data and the fact that the combination of zanza plus atezo was successful in a cold tumor where other TKI plus ICI combinations have failed.

當我們考慮鞏固和擴展我們的 GI 特許經營權時，我們對 STELLAR-303 的結果感到非常興奮。我們相信，在獲得監管部門批准後，這些數據將為 Exelixis 在結直腸癌（四大腫瘤之一）領域帶來極具吸引力的商業機會。許多醫生認為，免疫檢查點抑制劑能夠惠及更廣泛的人群，這對他們的患者來說非常重要。他們還認為，鑑於數據以及 Zanza 加 Atezo 的組合在其他 TKI 加 ICI 組合失敗的冷腫瘤中取得成功這一事實，Zanza 具有差異化優勢。

With all the appropriate caveats for cross-trial comparisons, the median OS for zanza of 10.9 months is on par with Lonsurf plus Avastin bevacizumab from the SUNLIGHT study. However, in the SUNLIGHT study, patients who had received prior bev had a median OS of only nine months. The bev pre-treated group will be relevant for the US population as approximately 75% of patients have received bev before reaching the third-line setting, and most of these patients have received bev in both the first- and second-line settings.

考慮到跨試驗比較的所有適當注意事項，zanza 的中位 OS 為 10.9 個月，與 SUNLIGHT 研究中的 Lonsurf 加 Avastin 貝伐珠單抗相當。然而，在 SUNLIGHT 研究中，接受過貝伐珠單抗治療的患者的中位總存活期僅為 9 個月。對於美國人群而言，接受過貝伐珠單抗預先治療的患者群體具有重要意義，因為約 75% 的患者在達到三線治療階段之前接受過貝伐珠單抗治療，而且這些患者中的大多數在一線和二線治療階段都接受過貝伐珠單抗治療。

Exelixis has had numerous successful launches with cabo. We are excited to expand on the commercial capabilities we have built over the last decade and to build on our GI franchise, where we already have experience in hepatocellular carcinoma and neuroendocrine tumors. As you know, we already have a significant GU presence, and for zanzalintinib, we would envision growing our GI infrastructure to a size and scale similar to our GU team. As Mike mentioned, we are expediting the buildout of our GI sales team as we see a great opportunity to continue to drive growth in the NET indication.

Exelixis 與 cabo 合作已成功推出多次產品。我們很高興能夠擴展過去十年建立的商業能力，並發展我們的胃腸道業務，我們在肝細胞癌和神經內分泌腫瘤方面已經積累了經驗。如您所知，我們已經在泌尿生殖系統領域擁有相當的實力，對於 zanzalintinib，我們設想將我們的胃腸道基礎設施發展到與泌尿生殖系統團隊類似的規模。正如麥克所提到的，我們正在加快組建 GI 銷售團隊，因為我們看到了繼續推動 NET 適應症成長的巨大機會。

Additionally, having a full GI team in place will provide important experience selling cabo as well as forming relationships with accounts to be ready for zanza. The incremental sales representatives will enable us to have greater reach in the community setting, which is a segment where our team has typically excelled. This buildout speaks to our confidence and excitement of cabo NET opportunities as well as zanzalintinib.

此外，組建一支完整的 GI 團隊將為銷售 cabo 提供重要的經驗，並與客戶建立關係，為 zanza 做好準備。新增的銷售代表將使我們能夠在社群領域擁有更大的影響力，而這正是我們團隊通常表現出色的領域。此次建設體現了我們對 cabo NET 機會以及 zanzalintinib 的信心和興奮。

In closing, we are pleased with the cabo business, both in RCC and NETs. In neuroendocrine tumors, prescribers see CABOMETYX as a more favorable choice versus other previously approved small molecule therapies. Additionally, the competition in the oral segment of the NET market are generic therapies, which puts CABOMETYX at a significant advantage with a full commercial organization energized and supporting the launch.

最後，我們對卡波業務（包括 RCC 和 NET）感到滿意。對於神經內分泌腫瘤，處方醫生認為 CABOMETYX 比其他先前核准的小分子療法更可取。此外，NET 市場口服藥物領域的競爭主要來自仿製藥，這使得 CABOMETYX 擁有顯著優勢，其完整的商業組織充滿活力，並為上市提供支援。

All of this taken together drives our conviction that the NET market will be a substantial opportunity for the CABOMETYX business. We are pleased that CABOMETYX plus nivolumab has achieved the regimen with the highest market share ever in first-line RCC setting as this sets up the brand for continued growth in kidney cancer.

綜上所述，我們堅信NET市場將為CABOMETYX業務帶來巨大的機會。我們很高興 CABOMETYX 聯合 nivolumab 方案在腎細胞癌一線治療中取得了有史以來最高的市場份額，這為該品牌在腎癌領域的持續增長奠定了基礎。

And with that, I will turn the call back over to Mike.

接下來，我將把電話轉回給麥克。

All right. Thanks, P.J. We will wrap up here with a big shout-out to the Exelixis' team to thank everyone for helping make our third quarter so successful. I'm pleased to see our collective commitment, focus and urgency continue at a high level as we advance our priorities across discovery, development and commercial activities.

好的。謝謝 P.J.。最後，我們要向 Exelixis 團隊致以熱烈的感謝，感謝大家幫助我們取得了第三季的巨大成功。我很高興看到，我們在推動發現、開發和商業活動等各項優先事項的過程中，繼續保持高度的集體承諾、專注和緊迫感。

On a personal note, after more than 35 years in the biopharma industry, Susan Hubbard, our EVP, Public Affairs and Investor Relations, has decided to retire to pursue her passions outside of her profession. We are incredibly fortunate that Susan joined us in 2014 with her depth of experience and broad expertise in both clinical and commercial. She provided strong leadership and guidance to help us navigate all the twists and turns we've encountered over the years as we grew into the company we are today.

就個人而言，在生物製藥行業工作超過 35 年後，我們的執行副總裁兼公共事務和投資者關係負責人 Susan Hubbard 決定退休，去追求她在職業之外的愛好。我們非常幸運，Susan 於 2014 年加入我們，她在臨床和商業方面都擁有豐富的經驗和廣泛的專業知識。多年來，在我們成長為今天的公司過程中，她給了我們強而有力的領導和指導，幫助我們度過了所有遇到的曲折和挑戰。

And I personally, again, I'm very grateful for Susan as she's been my go-to thought partner for framing the Exelixis narrative to all our various stakeholders, and we wish her all the best. Susan will be with us through the end of the year, and I'm confident our investor relations and public affairs teams are well equipped for the future.

我個人再次非常感謝Susan，因為她一直是我在向所有利益相關者闡述Exelixis故事時的首選思想夥伴，我們祝她一切順利。蘇珊將和我們一起工作到年底，我相信我們的投資者關係和公共事務團隊已經為未來做好了充分的準備。

Moving forward into 2026, Andrew Peters, currently Senior Vice President, Strategy, will add Investor Relations to his responsibilities reporting to Chris Senner. This is a natural move for Andrew, who joined Exelixis in 2018 following 12 years as a biopharma equity research analyst. To both Susan and Andrew. So we'll close here, and we look forward to updating you on our progress in the future, and thank you for your continued support and interest in Exelixis.

展望 2026 年，現任策略資深副總裁 Andrew Peters 將兼任投資人關係主管，並向 Chris Senner 匯報工作。對 Andrew 來說，這是一個順理成章的選擇。他在擔任生物製藥股票研究分析師 12 年後，於 2018 年加入 Exelixis。致蘇珊和安德魯。那麼，我們就先介紹到這裡，期待未來能向您報告我們的進展，感謝您一直以來對 Exelixis 的支持和關注。

And we're happy to now open the call for questions.

現在我們很高興開始接受提問。

(Operator Instructions) Silvan Tuerkcan, Citizens.

（操作員說明）Silvan Tuerkcan，公民。

Congratulations on all the progress. Maybe if you could just summarize the post-ESMO feedback that you had on the zanzalintinib results and how they match up with those points that you unveiled today regarding how you plan to position this product in the market.

祝賀你們取得的所有進展。或許您可以總結一下您在 ESMO 會議後收到的關於 zanzalintinib 結果的反饋，以及這些反饋與您今天公佈的關於您計劃如何在市場上定位該產品的要點是如何相符的。

Yes. Thanks, Silvan. P.J., do you want to start with that one? And then maybe Dana and I can provide some color commentary as needed.

是的。謝謝你，西爾萬。P.J.，你想先從那個開始嗎？然後，我和達娜或許可以根據需要提供一些評論。

Sure. Thanks for the question, Silvan. We've conducted extensive market research with the data that was presented at ESMO, which has really been very positive. Physicians are seeing the overall survival benefit as very important. They're certainly seeing the fact that we're bringing an IO to bear in one of the biggest tumors, one of the big four tumors, as I said, where IO hasn't been available, where TKI plus IO has filled in the past is also very important to physicians as well as the fact that this is a chemo-free option.

當然。謝謝你的提問，西爾萬。我們根據ESMO大會上公佈的數據進行了廣泛的市場調查，結果非常積極。醫生認為提高整體存活率非常重要。他們當然看到了一個事實：我們正在將免疫療法應用於最大的腫瘤之一，也就是四大腫瘤之一。正如我所說，免疫療法以前無法應用於這種腫瘤，而過去只能使用酪胺酸激酶抑制劑聯合免疫療法來治療。這對醫生來說也非常重要，因為這是一種不需要化療的選擇。

So what we've seen, as I think about this market, and as we see the market now, it's a very fragmented market. As you look at it, about a third of the market is Lonsurf-bev, a third of the third-line-plus market is TKI, and the final third of that market is really sort of a smattering of different chemos as well as various targeted therapies. So fragmented market really is one that provides opportunity should we be approved in the setting.

所以，當我思考這個市場，以及我們現在看到的市場時，我發現它是一個非常分散的市場。從這個角度來看，大約三分之一的市佔率屬於 Lonsurf-bev，三分之一的三線及以上市場屬於 TKI，而剩下的三分之一市場實際上是各種不同的化療藥物以及各種標靶療法的混合體。因此，分散的市場確實為我們提供了許多機會，前提是我們能夠在這樣的環境下獲得認可。

And our market research clearly indicates it will take market share from all the competitors in the space. So that's been certainly very positive as well. And as I mentioned, we're excited to build out our GI franchise capabilities and our sales team as the NET launch is going well. This gives us the opportunity to reach further in the community and continue to drive uptake in NET as well as to be really, fully prepared and optimized should we have the opportunity to launch zanza in the near future, so just very exciting all around.

我們的市場調查清楚地表明，它將從該領域的所有競爭對手手中奪取市場份額。所以這方面也確實非常正面。正如我之前提到的，隨著 NET 的推出進展順利，我們很高興能夠拓展我們的 GI 特許經營能力並壯大我們的銷售團隊。這讓我們有機會進一步拓展社區，繼續推動 NET 的普及，如果我們在不久的將來有機會推出 Zanza，也能做好充分的準備和優化，所以一切都令人非常興奮。

Sean Laaman, Morgan Stanley.

肖恩拉曼，摩根士丹利。

This is Katherine on for Sean. We had one looking at zanza and nccRCC ahead of the readout for STELLAR-304 in midyear '26. Could you help provide more color on why sunitinib is the right control given the various histologic subtypes that make up this population?

這裡是凱瑟琳替肖恩報道。在 2026 年中 STELLAR-304 的讀數公佈之前，我們曾對 zanza 和 nccRCC 進行研究。鑑於該族群包含各種組織學亞型，您能否進一步解釋為什麼舒尼替尼是合適的對照藥物？

Thanks for the question. This is Dana. Yes, so the comparator in 304 is sunitinib, which is a standard of care in this setting. We think it's a highly relevant comparator, especially given the overlap in target profile with zanza. And it's used quite extensively, especially ex-US, but a number of patients in the US are also treated with this. So it's a standard of care and thus is a good comparator to go with a Phase III pivotal trial.

謝謝你的提問。這是達娜。是的，所以 304 中的對照藥物是舒尼替尼，這是該領域中的標準治療藥物。我們認為這是一個非常相關的比較對象，特別是考慮到它與 Zanza 的目標概況存在重疊。這種療法應用相當廣泛，尤其是在美國以外，但美國也有許多患者接受這種療法治療。因此，它是一種標準治療方法，因此是進行 III 期關鍵性試驗的良好對照。

Paul Choi, Goldman Sachs.

Paul Choi，高盛。

This is Karishma on for Paul. Congrats on the quarter. So given the performance in the STELLAR-303 initial cut of data from ESMO, can you help us level set expectations for the NLM cut coming out early next year? And particularly, we were interested in the idea of powering with relation to the study given that Lonsurf-bev had approximately 500 patients in their Phase III study. Can you speak to your decision to enroll roughly 900 patients in STELLAR-303 and the overall implications?

這是卡里什瑪替保羅報道。恭喜你本季取得佳績。鑑於 ESMO 公佈的 STELLAR-303 初步篩選數據表現良好，您能否幫助我們設定對明年初公佈的 NLM 篩選數據的預期？尤其讓我們感興趣的是，鑑於 Lonsurf-bev 的 III 期研究約有 500 名患者，因此我們考慮了與研究相關的統計功效問題。您能否談談您決定在 STELLAR-303 研究中招募約 900 名患者的原因以及其整體影響？

Yes, it's kind of hard to hear your question with all the background noise. So Dana, can you navigate that one?

是的，背景噪音太大，很難聽清楚你的問題。達娜，你能搞定這件事嗎？

Sure. So the study started out, or the prior iteration before it was had dual primary end points, and had a single primary endpoint in patients with non-liver metastases. We use scientific rationale to look at that, especially with emerging data coming from the LEAP-017 trial and other studies showing that those patients without liver metastases seem to do better with IO.

當然。因此，該研究最初（或先前的版本）有兩個主要終點，並且在非肝轉移患者中有一個主要終點。我們運用科學原理來研究這個問題，特別是來自 LEAP-017 試驗和其他研究的新數據表明，沒有肝轉移的患者似乎在接受 IO 治療後效果更好。

But as the trial evolves, and as we were accruing patients and events, we realized that we had an important opportunity to potentially bring the results in earlier with the ITT population, meaning with the strong contribution of events from the patients with liver metastases. It's a much poorer prognosis with those patients. The disease is much more aggressive. They progress faster. They achieve events for overall survival faster. So that's where we realized we really needed to change the trial so that we could get endpoints in both the non-liver mets and the full ITT population.

但隨著試驗的進行，隨著我們不斷累積患者和事件，我們意識到我們有一個重要的機會，可以更早地從 ITT 族群中獲得結果，這意味著肝轉移患者的事件貢獻很大。這些患者的預後就差得多。這種疾病更具侵襲性。他們進步更快。它們能更快實現整體生存目標。因此，我們意識到我們真的需要改變試驗，以便我們能夠在非肝轉移患者和整個 ITT 族群中獲得終點。

So the result that we presented in Berlin a couple of weeks ago, it's a combined analysis of both liver mets and non-liver mets, the entire ITT population. That population is a little bit skewed toward non-liver mets patients in that we put a cap on the amount of patients with liver metastases that could enroll in the trial.

因此，我們幾週前在柏林公佈的結果，是對肝轉移和非肝轉移患者，即整個 ITT 族群的綜合分析。此族群中非肝轉移患者的比例略有偏高，因為我們限制了可以參加試驗的肝轉移患者的數量。

So typically, a trial population that doesn't manage liver mets the way we did will be about 80% liver mets and 20% to 30% non-liver mets. We had about 38% non-liver mets, so that certainly changed the dynamics of the trial, but the results that we achieved was in the entire population. So as we said, because the non-liver mets progressed a little more slowly, we expect to see results in that subgroup sometime next year around the middle of next year.

因此，通常情況下，如果不採用我們的方式來處理肝轉移，試驗族群中約 80% 為肝轉移患者，20% 至 30% 為非肝轉移患者。我們有大約 38% 的患者出現非肝轉移，這無疑改變了試驗的動態，但我們所取得的結果是在整個人群中取得的。正如我們所說，由於非肝轉移進展較慢，我們預計該亞組的結果將在明年年中左右公佈。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

I want to offer my congratulations on both the top- and bottom-line growth here, which are really impressive. So I have a question on this: Merck announced LITESPARK-011 was positive, and one could assume that they'll be putting effort into marketing belzu plus lenvatinib combination in second-line RCC patients.

我謹對公司營收和利潤的雙雙成長表示祝賀，這真的令人印象深刻。我對此有個疑問：默克公司宣布 LITESPARK-011 研究結果為陽性，人們可能會認為他們將努力推廣 belzu 加 lenvatinib 聯合療法用於二線 RCC 患者。

We all know that zanza is a better drug than lenvatinib, but there could be a lot of population overlap between LITESPARK-011 and the belz and zanza cohort in KEYMAKER-U03. So does that reduce the probability that Merck will want to pursue a pivotal second-line study with belz and zanza? And then if I can sneak one in an extra in here, what was the clinical trial contribution for cabo sales in 3Q?

我們都知道 zanza 比 lenvatinib 更好，但 LITESPARK-011 與 KEYMAKER-U03 中的 belz 和 zanza 隊列之間可能存在許多人群重疊。那麼，這是否會降低默克公司進行貝爾茲和讚札二線關鍵性研究的可能性？如果我能偷偷補充一個問題，臨床試驗對第三季卡波銷售額的貢獻是多少？

Chris, take that second question first.

克里斯，先回答第二個問題。

Sure. So Asthika, it's Chris. There were actually no clinical trial sales in the quarter.

當然。所以 Asthika，我是 Chris。本季實際上沒有臨床試驗銷售額。

And yes, it's Mike. The first question was a long drawn-out question with lots of twists and turns. We are confident that the Merck trials that we've been discussing for the last year will continue and start later this year. So I don't want to say more than that. I don't want to speculate on other people's data, especially when there's only a press release. We're excited about that collaboration, and we'll see that moving forward.

沒錯，他就是麥克。第一個問題冗長而曲折。我們有信心，過去一年來我們一直在討論的默克公司的試驗將會繼續進行，並在今年晚些時候開始。所以我不想再多說了。我不想對別人的數據妄加猜測，尤其是只有一份新聞稿的情況。我們對這次合作感到非常興奮，並期待未來的發展。

Akash Tewari, Jefferies.

阿卡什‧特瓦里，傑富瑞集團。

This is Anastasia on for Akash. So do you see any risk to your STELLAR-303 trial approval given that Vinay was publicly apprehensive about the usefulness of CABINET?

這是阿納斯塔西亞替阿卡什解說。鑑於 Vinay 曾公開對 CABINET 的效用表示擔憂，您認為 STELLAR-303 試驗的批准是否有任何風險？

I'm sorry, do you mind repeating the question? I don't think we got all that.

不好意思，您能再問一次嗎？我覺得我們並沒有完全理解。

Yes, for sure. So do you see any risk to your STELLAR-303 trial, specifically its approval, given that Vinay has been publicly apprehensive about the usefulness of CABINET?

是的，當然。鑑於 Vinay 曾公開對 CABINET 的效用表示擔憂，您認為您的 STELLAR-303 試驗（特別是其核准）是否有任何風險？

Yes. I wouldn't want to comment on that. Thank you.

是的。我不想對此發表評論。謝謝。

Andy Hsieh, William Blair.

謝家華，威廉布萊爾。

Well, first and foremost, Susan, I congratulate you on the illustrious career in the biopharma industry. You've been a mentor to so many of us. I’m really happy for you, and I'll miss working with you dearly. My question has to do with the NET population. Obviously, a very, very successful launch. As you look forward to the zanza Phase III trial, I'm curious about the strategy in terms of navigating the potential cannibalization as cabo is being used in the beta line, potentially entrenching in the earlier lines by setting?

首先，蘇珊，我要祝賀你在生物製藥行業取得了輝煌的成就。你一直是我們許多人的良師益友。我真為你高興，我會非常想念和你一起工作的日子。我的問題與NET人群有關。顯然，這是一次非常非常成功的發布。在您期待 Zanza III 期試驗之際，我很好奇，由於 Cabo 已用於 Beta 線，可能會通過某種方式鞏固早期線材的地位，因此，如何應對潛在的蠶食效應？

P.J., go ahead.

P.J.，請講。

Yes. Thanks for the question, Andy. In terms of NET, as you mentioned, we're really pleased with the launch and how it's going. I mentioned kind of 50% demand growth quarter over quarter. We're pleased with certainly the broad utilization across all the relevant demographics in the population. And kind of very early innings here as we're still building new patient share, and obviously, only approved at the very end of March. A lot of opportunity for these patients to get refilled and continue the business with regards to demand going forward.

是的。謝謝你的提問，安迪。就NET而言，正如您所提到的，我們對它的發布以及目前的進展非常滿意。我提到過，需求較上季成長了大約 50%。我們非常高興看到該產品在所有相關人群中得到廣泛應用。目前還處於非常早期的階段，因為我們仍在努力拓展新的患者群體，而且顯然，這項技術也是在三月底才獲得批准的。對於這些患者來說，有很多機會可以繼續獲得處方藥，並隨著未來需求的增長而繼續開展業務。

As we think about zanza in the long term, it's just a very different study in terms of having an active comparator. And it's really designed to position that very competitively and upfront in the market, but that's far down the road. I think in the near term, there's just so much room for cabo in NETs to really become a key player there.

從長遠來看，Zanza 的研究與以往的研究截然不同，因為它有一個活躍的對照組。它的設計初衷是為了在市場上佔據極具競爭力的領先地位，但這還很遙遠。我認為在短期內，cabo 在 NETs 領域有很大的發展空間，完全有可能成為其中的關鍵參與者。

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

Apologies if this was already asked in a different capacity, but I believe I heard that the other subgroup part of the dual primary endpoint for STELLAR-303 might only come to maturity maybe sometime early next year, yet with the NDA submission that you guys are planning for by year end 2025, could we still expect a broad label for CRC, including both subgroups to be in play?

如果這個問題之前已經以其他方式問過，我深感抱歉。但我聽說 STELLAR-303 的雙重主要終點中另一個亞組部分可能要到明年年初才能成熟，但考慮到你們計劃在 2025 年底前提交 NDA，我們是否仍然可以期待該藥物獲得包括這兩個亞組在內的廣泛 CRC 適應症？

Or will there be some sort of rolling submission that needs to happen to include that cohort of the primary endpoint? And then just secondly, a follow up, was the need for both subgroups being split up as a result of guidance from regulators to achieve having both of those non-liver mets and liver mets included on the initial label for zanza?

或者是否需要進行某種滾動提交，才能將該組主要終點數據納入其中？其次，還有一個後續問題，是否由於監管機構的指導，需要將這兩個亞組分開，以便將非肝轉移和肝轉移都納入 Zanza 的初始標籤中？

Sure. Thanks for the question. This is Dana. So we can file, and we will file based on the single hit on one of the dual primary endpoints in the ITT population. And I just want to clarify, the ITT population is not a subpopulation. It is the entire population of the trial, so that would give us, in our view, the broadest label. The NLM subgroup is a subpopulation within the trial. It's just a second dual primary endpoint in the trial. So we're proceeding with our filing. And as we said, we expect to get that in very soon, depending on the government reopening for business.

當然。謝謝你的提問。這是達娜。因此，我們可以提交申請，並且我們將根據 ITT 人群中雙主要終點之一的單一命中結果提交申請。我還要澄清一下，ITT人群不是一個子人群。這是試驗的全體人群，因此我們認為這將給我們一個最廣泛的標籤。NLM亞組是試驗中的一個子群體。這只是該試驗中的第二個雙重主要終點。所以我們正在繼續推進申請流程。正如我們所說，我們預計很快就能收到貨，這取決於政府何時重新開放商業活動。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Congrats on the quarter. This is Sarah on for Yaron. Quick question from us on your early-stage pipeline. I know you mentioned you have an R&D Day coming up, but if you could just give us a quick sneak peek on your four Phase I programs. Can you maybe prioritize among them, which one you expect to transition next into pivotal development? And maybe if you could speak a little bit on XB371 in particular, which is your tissue factor TOPO1-ADC. Maybe just discuss a little bit how it's differentiated from other TOPO1s.

恭喜你本季取得佳績。這裡是莎拉替亞倫發言。我們有一個關於你們早期研發管線的小問題。我知道您曾提到即將舉辦研發日活動，但如果您能為我們快速透露您的四個 I 期專案的情況就太好了。您能否從中選出一個優先順序最高的，您認為哪個專案會成為下一個關鍵發展階段？或許可以特別談談 XB371，也就是您的組織因子 TOPO1-ADC。或許可以稍微討論一下它與其他 TOPO1 的差異。

Sure. Thanks for the question. I don't want to preempt too much around what we're going to say next month. What I can tell you is that 309 and 010 - 309 is our USP1 inhibitor and 010 is our 5T4-targeting ADC. Those have been in the clinic longer. So those have accrued more patients, obviously. XB628, our bispecific IO molecule targeting PD-L1 and NKG2A started its Phase I trial a few months ago. So that’s been enrolling well.

當然。謝謝你的提問。我不想太早透露我們下個月要說的內容。我可以告訴你們的是，309 和 010——309 是我們的 USP1 抑制劑，而 010 是我們的 5T4 標靶 ADC。那些人在診所待的時間更長。所以很顯然，這些醫院累積了更多病人。XB628 是我們針對 PD-L1 和 NKG2A 的雙特異性免疫腫瘤分子，幾個月前開始了 I 期臨床試驗。所以，招生狀況一直不錯。

And then 371, which is, as you mentioned, the tissue-factor targeting ADC with the topoisomerase 1 inhibitor payload, that is our most recent IND filing. That Phase I trial got up and running very recently, but it's already enrolling patients. And what's exciting about that molecule, since you asked specifically about what differentiates it, is it utilizes a differentiated antibody that has no impact on the coagulation cascade and also has the tandem mechanism release linker that we licensed from Catalent to release the payload. It's sort of a belt and suspenders approach for stabilizing the payload in circulation. So it requires both glucuronidase cleavage and then a tandem cleavage by a peptidase inside the cells for payload release. So we think that's what differentiates it, plus we also feel that we are kind of ahead of any others in terms of investigating a molecule like this in the clinic.

然後是 371，正如您所提到的，它是靶向組織因子的 ADC，含有拓撲異構酶 1 抑製劑有效載荷，這是我們最新的 IND 申請。該 I 期試驗最近才啟動，但已經開始招募患者。既然你特別問到了該分子的獨特之處，那麼令人興奮的是，它利用了一種差異化的抗體，這種抗體不會影響凝血級聯反應，並且還具有我們從 Catalent 獲得許可的串聯機制釋放連接子，用於釋放有效載荷。這是一種雙重保險的方法來穩定流通中的有效載荷。因此，需要先用葡萄醣醛酸酶切割，然後再用肽酶在細胞內進行串聯切割才能釋放有效載荷。所以我們認為這就是它的獨特之處，而且我們也覺得我們在臨床上研究這類分子方面領先於其他任何人。

Michael Schmidt, Guggenheim.

麥可·施密特，古根漢美術館。

I had one on zanza, specifically the opportunity based on the STELLAR-304 study. Just help us understand the size of this commercial opportunity in non-clear cell RCC. And how much CAP use is driven in non-clear cell right now? And then lastly, just the minor delay to mid-2026 from the first half, is that based on event rate slowdown? Or is there something else going on there?

我在 Zanza 上有一個投資機會，具體來說是基於 STELLAR-304 研究的機會。請幫助我們了解非透明細胞腎細胞癌領域這項商業機會的規模。目前非透明電池中 CAP 的使用量是多少？最後，從上半年到 2026 年年中略微推遲，這是基於事件發生率放緩的考慮嗎？或者，那裡還有其他事情發生？

Yes. Michael, this is P.J. Certainly excited about the opportunity to get a readout from STELLAR-304 and then the potential to get zanza approved in the kidney cancer space. Obviously, a space we know really well. Non-clear cell accounts for approximately 20% to 25% of the patients in the space. And cabo has utilization there as do many other agents. But certainly, we think that a Phase III study having a positive result would really move the needle in that space to demonstrate, with greater level of evidence and support, benefit for patients.

是的。Michael，我是 P.J.。我非常興奮能有機會獲得 STELLAR-304 的試驗結果，並期待 Zanza 能在腎臟癌領域獲得批准。顯然，這是我們非常熟悉的領域。非透明細胞癌約佔該領域患者的 20% 至 25%。卡波聖盧卡斯在那裡有客流，其他許多代理商也是如此。但我們認為，如果 III 期研究取得積極結果，將真正推動該領域的發展，以更高的證據和支持證明對患者的益處。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Susan, you'll be missed. My question is on the NET cabo launch. Just wondering, a pretty impressive share of -second-line oral therapies, I was just curious, are orals getting a greater share relative to Lutathera? Or is the dynamic between orals and Luta in second line relatively stable? And if I could just squeeze one in, the MSN patent appeal, is there a timeline on that?

蘇珊，我們會想念你的。我的問題是關於NET cabo的發布。我只是好奇，二線口服療法的份額相當可觀，我很好奇，口服療法相對於 Lutathera 的份額是否更大？或者說，口服藥物和二線藥物 Luta 之間的動態關係是否相對穩定？如果我能擠出一點時間問一下，MSN的專利申請上訴有時間表嗎？

Yes. With regards, this is P.J. Thanks for the question, Jason. As you mentioned, we're very pleased with the NET launch. And as we look at the second-line plus oral share, we've already exceeded 40% new patient share there, which we're pleased with. As I mentioned, those are patients just coming on therapy. So we think we certainly have room to benefit from the duration of therapy that those patients would achieve. And we think we can continue to grow share in the space.

是的。您好，我是P.J.。謝謝你的提問，Jason。正如您所說，我們對NET的發布非常滿意。當我們審視二線治療及口服藥物的市場份額時，我們已經超過了40%的新患者份額，對此我們感到滿意。正如我之前提到的，這些都是剛開始接受治療的患者。因此，我們認為，我們肯定能從這些患者所接受的治療持續時間中獲益。我們認為我們能夠繼續擴大在該領域的市場份額。

With regards to Lutathera in the second-line plus setting, broadly orals constitute a greater portion of that market. But where Lutathera is utilized, cabo really is the preferred treatment post-Lutathera, as ours is really the only study that had patients in it who were pre-treated with Lutathera, which is why that sort of broad study base in a contemporary setting is really benefiting us in the marketplace.

就 Lutathera 在二線及以上治療方案中的應用而言，口服藥物總體上佔據了該市場更大的份額。但是，在使用 Lutathera 的情況下，卡波西汀實際上是 Lutathera 治療後的首選治療方法，因為我們的研究是唯一一項納入了預先接受 Lutathera 治療的患者的研究，這就是為什麼在當代環境下開展如此廣泛的研究基礎確實對我們在市場上有利。

Yes, Jason, it's Mike. On the patent topic, we don't have anything to offer up on that today.

是的，傑森，我是麥克。關於專利問題，我們今天沒有什麼可以透露的。

Leonid Timashev, RBC.

列昂尼德·蒂馬舍夫，RBC。

I wanted to ask a little bit on the meningioma opportunity. Just curious sort of how you're thinking about the emerging investigator-sponsored data with cabo and how that applies to zanza and your confidence there? And then ultimately, what you think the size of that opportunity may be?

我想稍微了解一下腦膜瘤的治療機會。我只是好奇您如何看待 Cabo 中湧現的研究者贊助數據，以及這些數據如何應用於 Zanza，您對這些數據的信心如何？那麼最終，你認為這個機會的規模有多大？

Sure. This is Dana. Thanks for the question. Regarding what was seen with cabo, so you probably know the story, but there's a published case report where a patient with thyroid cancer treated with cabo had meningioma, and they noticed a very substantial reduction in the size of that tumor, and nd that's not a common occurrence with targeted therapies. A number of different studies noted response rates for targeted therapies, especially VEGF or VEGFR targeted therapies in the single-digit range, 3% or less.

當然。這是達娜。謝謝你的提問。關於卡波西氏肉瘤的療效，你可能已經知道了，但有一份已發表的病例報告，其中一名接受卡波西氏肉瘤治療的甲狀腺癌患者同時患有腦膜瘤，他們注意到該腫瘤的體積大幅縮小，而這在標靶治療中並不常見。許多不同的研究指出，標靶治療（尤其是 VEGF 或 VEGFR 標靶治療）的反應率在個位數範圍內，3% 或更低。

So these investigators got very excited and launched an investigator-sponsored trial where they looked at a number of patients treated with cabo, and they saw response rates depending on the criteria that are used anywhere in the 25% to 75% range. So that was quite exciting to us and showed the impact of the target profile of cabo. And as we've said, we feel that zanza is sort of a best-in-class molecule with a cabo-like target profile. So it's a natural progression for us to look for a white-space-targeting trial with zanza. So we're very excited about that trial. And as I indicated, we expect that trial to get up and running in 2026.

因此，這些研究人員非常興奮，並啟動了一項研究者贊助的試驗，他們觀察了許多接受卡波西肉鹼治療的患者，發現根據所使用的標準，反應率在 25% 到 75% 的範圍內。這讓我們感到非常興奮，也展現了卡波聖盧卡斯目標客群的影響力。正如我們所說，我們認為 Zanza 是一種同類最佳的分子，具有類似 Cabo 的目標特性。因此，對我們來說，尋找針對空白市場的 Zanza 試驗是一個自然的發展方向。所以我們對那次試驗感到非常興奮。正如我之前所說，我們預計該試驗將於 2026 年啟動並運行。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

Maybe a similar question just on the planned Phase III trial in post-chemo adjuvant CRC. And so I guess when I look at the STELLAR-303, the zanza dose intensity, I guess it was pretty low. And just curious if you're intending to do any additional dose exploration work just to make sure that dose intensity doesn't become a rate-limiting factor in a setting where tolerability tends to be prioritized.

或許可以就計畫進行的化療後輔助性 CRC III 期試驗提出類似的問題。所以，當我查看 STELLAR-303 時，我想它的讚札劑量強度相當低。我只是好奇您是否打算進行任何額外的劑量探索工作，以確保在耐受性往往被優先考慮的情況下，劑量強度不會成為限制因素。

Yes, so this is Dana. I'll take that. In our plans for further exploration in colorectal, this really comes from the result from STELLAR-303. It's the first demonstration of a positive result in non-MSI-high patients with an IO-containing regimen. So it's natural for us to want to bring that earlier in lines of therapy for patients. And this is some white space in colorectal cancer that we identified as high unmet need.

是的，這位就是達娜。我接受。我們對大腸直腸疾病的進一步探索計劃，實際上源自於 STELLAR-303 研究的結果。這是首次證明含免疫療法方案對非 MSI 高表現患者有正向療效。因此，我們自然希望儘早將這種方法引入患者的治療方案中。這是我們在結直腸癌領域發現的一些尚未滿足的重大需求空白。

So in patients with high risk of recurrence, the median disease-free survival is in the six-month range. So we think we can get an answer from this study quite quickly. Now in terms of dose, it's natural, and as we've seen with other agents, for example with cabo, that as you move up earlier lines of therapy, you often will look at other doses. So we certainly are intending to look at other doses with zanza. I would just say stay tuned for more information around that when we finally kind of launch the trial and divulge more details.

因此，對於復發風險高的患者，中位無疾病存活期約為六個月。所以我們認為這項研究可以很快給出答案。至於劑量方面，這是很自然的，正如我們從其他藥物（例如卡波西肉鹼）中看到的那樣，隨著早期治療方案的推進，你通常會考慮其他劑量。因此，我們當然打算研究 Zanza 的其他劑量。我只想說，敬請關注後續訊息，我們會在正式啟動試驗並公佈更多細節時發布相關資訊。

Jay Olson, Opp Co.

Jay Olson，Opp 公司

This is Cheng on the line for Jay. Congrats on the quarter. Also want to thank Susan for all the help in the past years, and congrats on the retirement. As we are seeing several bispecific programs are now actually being developed in the first-line CRC, so how are you thinking about the potential impact of those novel agents? And how will that impact the later line uptake of the atezo plus zanza? And if I could sneak in one clarification question, for the STELLAR-303 trial based on ITT population, just wondering why couldn't you file earlier because the top-line results were a few months ago?

這是程在幫Jay打電話。恭喜你本季取得佳績。也要感謝蘇珊過去幾年來的幫助，並祝賀她退休。我們看到，目前已有幾種雙特異性藥物正在第一線CRC治療中應用，您如何看待這些新型藥物的潛在影響？那這將如何影響後續Atezo加Zanza的上市情況？如果我能偷偷問一個澄清問題，關於基於 ITT 人群的 STELLAR-303 試驗，我想知道為什麼你們不能更早提交申請，因為主要結果幾個月前就已經公佈了？

Yes. We're having a hard time understating you. Nobody is filing new NDAs right now with the government being closed, so be aware of that. And whether it be a new NDA or a new BLA, there's no filings currently with the government shutdown. So just keep that in mind, and we're hoping to file ASAP when the government reopens.

是的。我們很難低估你。目前政府部門關閉，沒有人會提交新的保密協議，請注意這一點。無論是新的保密協議還是新的生物製品許可協議，由於政府停擺，目前都沒有任何文件提交。所以請記住這一點，我們希望政府重新開放後儘快提交申請。

In terms of the bispecifics and that emerging landscape, there’s certainly interesting science, early clinical data. Kind of hard to opine on how that's going to change the marketplace without pivotal trials even being started, much less reading out. So I think we should just stay tuned on that and understand that it's a moving landscape across the board. And obviously, data drives the process. And we'll keep our data certainly moving as well, and we'll always be able to layer in our data with whatever emerging data is available.

就雙特異性抗體和新興領域而言，確實存在一些有趣的科學研究和早期臨床數據。在關鍵性試驗尚未開始，更不用說公佈結果之前，很難對這將如何改變市場發表意見。所以我覺得我們應該繼續關注這件事，並且明白這是一個瞬息萬變的局面。顯然，數據驅動著整個過程。我們當然也會不斷更新數據，並且始終能夠將我們的數據與任何新出現的數據進行疊加。

Ash Verma, UBS.

阿什維爾馬，瑞銀集團。

So I just wanted to come back on the CRC market dynamic that you mentioned that zanza plus beva is roughly one-third of this third-line market right now. But just the physician feedback that we've been getting is that is a growing part, so by the time that you get to the market with zanza-atezo, what is your assumption with how much would that share will be? And then yes, there is some sort of difference in the SUNLIGHT study based on the prior beva exposure but has that been slowing down the adoption of that regimen?

所以我想回到你提到的CRC市場動態，目前Zanza加Beva大約佔三線市場的三分之一。但我們從醫生那裡得到的回饋是，這部分市場份額正在不斷增長，所以當zanza-atezo上市時，您預計這部分市場份額會是多少？是的，SUNLIGHT 研究顯示，先前接觸過貝伐珠單抗的患者與接受過貝伐珠單抗治療的患者之間存在一些差異，但這是否減緩了此治療方案的推廣應用？

Yes. Thanks for the question. I'll say we've been conducting market research in CRC for quite some time. And I will say that what we've seen is that the share of the SUNLIGHT regimen has actually been relatively stable. So if that continues moving forward, the market certainly remains fragmented, as I said, about a third SUNLIGHT, a third TKI, a third other, which really represents a great opportunity for us, particularly in that our research with numerous physicians.

是的。謝謝你的提問。我想說，我們已經在CRC進行市場調查相當長一段時間了。而且我可以說，我們看到的是，SUNLIGHT 療法的份額實際上一直相對穩定。所以如果這種情況繼續下去，市場肯定會像我剛才說的那樣繼續分散，大約三分之一是 SUNLIGHT，三分之一是 TKI，三分之一是其他藥物，這對我們來說確實是一個絕佳的機會，尤其是在我們與眾多醫生合作進行研究的情況下。

When we do research, we're talking to over 100 physicians in the community as well as academia to get a really good sample size. And we're hearing from them that we'll get uptake in this third line plus setting and take share from all competitors, so we're optimistic about that.

我們進行研究時，會與社區和學術界的 100 多位醫生進行交流，以獲得足夠大的樣本量。我們從他們那裡了解到，我們將在第三線及以上市場獲得認可，並從所有競爭對手那裡奪取市場份額，所以我們對此持樂觀態度。

This is why we're increasing - one of the reasons in addition to driving more NET with cabo - our sales force because CRC is treated heavily in the community. This is a very common tumor type. So lots of prescribers here. So we're going to get ahead of that and really be able to have a strong reach into the community setting.

這就是為什麼我們要增加銷售團隊的原因之一——除了透過 cabo 推動更多 NET 之外——因為 CRC 在社群中受到嚴厲對待。這是一種非常常見的腫瘤類型。這裡有很多開處方的醫生。所以我們要搶佔先機，真正能夠深入社區。

Christopher Liu, Lucid Capital Markets.

克里斯托弗·劉，Lucid Capital Markets。

Maybe one that is more around capital allocation and financial strategy. With the share buybacks that have already been done and that are planned, going forward, how are you thinking about incremental buybacks versus things like business development or clinical investment opportunities? And do you feel like there's going to be a point where share buybacks would be less favored for some of these other potential value generators?

或許可以找一本更側重於資本配置和財務策略的。對於已經完成和計劃中的股票回購，展望未來，您如何看待逐步回購與業務發展或臨床投資機會等事項之間的關係？您是否認為，對於其他一些潛在的價值創造者而言，股票回購將會不再那麼受歡迎？

Yes, this is Chris. So generally, we think of capital allocation in the three elements, right? It's R&D, it's business development and share repurchases. And we think with the revenue growth we're generating and with the continued prudent expense management, we're including R&D expense in the $1 billion range, we think that we'll be able to fund all three of those elements, and we'll continue to invest in R&D and invest in BD and invest in share repurchase.

是的，這是克里斯。所以，我們通常會從三個要素來考慮資本配置，對吧？包括研發、業務拓展和股票回購。我們認為，憑藉我們目前的營收成長以及持續審慎的費用管理（包括研發費用約 10 億美元），我們將能夠為這三個方面提供資金，我們將繼續投資於研發、業務拓展和股票回購。

Thank you, at this time, there are no further questions. And so I will turn the call over to today's host, Susan Hubbard. Ms. Hubbard?

謝謝，目前沒有其他問題了。那麼，我將把電話交給今天的主持人蘇珊·哈伯德。哈伯德女士？

Thank you, Cherie, and thank you all for joining us today. We certainly welcome your follow-up calls with any additional questions you may have. Thank you.

謝謝Cherie，也謝謝大家今天能來參加。如果您還有其他問題，我們非常歡迎您後續來電諮詢。謝謝。

This concludes today's program. Thank you all for participating. You may now disconnect.

今天的節目到此結束。感謝大家的參與。您現在可以斷開連線了。