Exelixis Inc (EXEL) 2025 Q2 法說會逐字稿

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

女士們、先生們，大家好，歡迎參加 Exelixis 2025 年第二季財務業績電話會議。我叫 Towanda，今天我將擔任您的接線生。提醒一下，本次通話將會被錄音以便重播。

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

現在，我想將電話轉給今天的主持人、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, Towanda, and thank you all for joining us for the Exelixis second quarter 2025 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; PJ Haley, our Executive Vice President of Commercial; Amy Peterson, our Chief Medical Officer; and Dana Aftab, our Chief Scientific Officer, who will review our progress for the second quarter 2025, ending June 30, 2025.

謝謝你，Towanda，也謝謝大家參加 Exelixis 2025 年第二季財務業績電話會議。參加今天電話會議的還有我們的總裁兼執行長 Mike Morrissey、我們的財務長 Chris Senner、我們的商業執行副總裁 PJ Haley、我們的首席醫療官 Amy Peterson 和我們的首席科學官 Dana Aftab，他們將回顧我們在 2025 年第二季度（截至 2025 年 6 月 30 日）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，我們將參考未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天的新聞稿，了解我們使用此類非 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.

在本次演示過程中，我們將對未來事件和公司未來表現做出前瞻性陳述。這包括有關發現、產品開發、監管、商業、財務和策略事務、潛在成長機會以及政府藥品定價政策和舉措的可能發展的聲明。當然，實際事件或結果可能會有重大差異。

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 can cause actual results to different materially from those expressed by the company verbally and in writing today, including without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements are dependent on collaboration partners and the level of costs associated with discovery, product development, business development and commercialization activities.

請您參閱我們不時向美國證券交易委員會 (SEC) 提交的文件，這些文件在「風險因素」標題下列出了可能導致實際結果與公司今天口頭和書面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、遵守適用監管要求有關的風險和不確定性，這些都取決於合作夥伴和不確定性，這些都取決於開發

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

說完這些，我將把電話轉給麥克。

All right, thank you Susan, and thanks to everyone for joining us on the call today. Exelixis had a strong second quarter, accelerating our progress and building momentum across all components of our business. Driving growth of the cabozantinib franchise now catalyzed by the early stage of a successful NET launch is our top priority, while we execute on our R&D strategy to build a multi-compound, multi-franchise oncology business. All corporate activities are aligned on a single focus to improve the standard of care for patients with cancer.

好的，謝謝你，蘇珊，也謝謝大家今天參加我們的電話會議。Exelixis 在第二季度表現強勁，加速了我們的進步並為我們業務的所有組成部分積累了動力。在 NET 成功上市的早期階段的催化下，推動卡博替尼特許經營權的成長是我們的首要任務，同時我們執行研發策略，以建立多化合物、多特許經營權的腫瘤學業務。所有公司活動都圍繞著一個目標，即提高癌症患者的護理標準。

The magnitude of our future success will be determined by increasing the number of cancer patients we seek to serve and, ultimately, the impact we have on their disease with current and future Exelixis medicines. By driving for success across all components of our business, we hope to solidify our leadership in oncology drug discovery, development and commercialization through intensity, innovation and collaboration.

我們未來成功的大小將取決於我們尋求服務的癌症患者數量的增加，以及最終我們目前和未來的 Exelixis 藥物對他們的疾病的影響。透過推動業務各環節的成功，我們希望透過強度、創新和協作來鞏固我們在腫瘤藥物發現、開發和商業化方面的領導地位。

Key highlights for the second quarter include, first, the robust performance of the cabozantinib US business, with strong growth in demand and revenue from our commercial activities. Cabozantinib continues to build on its leadership position as the leading TKI for RCC. Second quarter 2025, US cabo franchise in their private revenues grew 19% year over year to $520 million compared to $438 million in the second quarter of 2024.

第二季的主要亮點包括：首先，卡博替尼美國業務表現強勁，需求和商業活動收入強勁成長。卡博替尼繼續鞏固其作為 RCC 領先 TKI 的領導地位。2025 年第二季度，美國卡波特許經營權的私人收入年增 19%，達到 5.2 億美元，而 2024 年第二季為 4.38 億美元。

Cabo's second quarter growth is noteworthy as it relates solely to commercial demand with negligible benefits from clinical trial sales and significant gross-to-net headwinds. Importantly, we saw brisk full quarter sales for the recently approved NET indications and already built a leading share in the oral second-line-plus NET segment, which contributed to approximately 4% of our second quarter 2025 NET product revenue.

Cabo 的第二季成長值得關注，因為它僅與商業需求有關，臨床試驗銷售帶來的好處微乎其微，而且總收入與淨收入之間存在顯著的阻力。重要的是，我們看到最近批准的 NET 適應症在整個季度的銷售表現強勁，並且已經在口服二線加 NET 領域佔據領先份額，這為我們 2025 年第二季度的 NET 產品收入貢獻了約 4%。

PJ will provide more information and commentary about our second quarter franchise performance and encouraging dynamics of the NET launch in his prepared remarks. And just last Thursday, our partner Ipsen received approval for NET from the European Commission, and revenues from this important indication, as it rolls out across Europe, will add to our royalty stream. We will continue to evaluate further updates to our 2025 financial guidance as we build momentum on the NET launch and gain further clarity on additional revenue opportunities for the second half of 2025.

PJ 將在其準備好的發言中提供更多有關我們第二季度特許經營業績以及 NET 發布的令人鼓舞的動力的信息和評論。就在上週四，我們的合作夥伴益普生 (Ipsen) 獲得了歐盟委員會對 NET 的批准，隨著這一重要適應症在歐洲的推廣，其收入將增加我們的特許權使用費收入。隨著 NET 發布的勢頭增強，並進一步明確 2025 年下半年的額外收入機會，我們將繼續評估 2025 年財務指導的進一步更新。

Second, as outlined previously, zanzalintinib is rapidly advancing as our next oncology-franchise opportunity, and the subject of numerous ongoing and soon-to-start pivotal trials. We're pleased with the positive topline results from STELLAR-303 in CRC and look forward to engaging with regulators with the intent of filing for approval in this indication as quickly as possible. STELLAR-304 in non-clear cell RCC is fully enrolled and continues to progress with the topline results expected in the first half of 2026, pending event rates.

其次，如前所述，zanzalintinib 作為我們的下一個腫瘤特許經營機會正在迅速發展，並且是眾多正在進行和即將開始的關鍵試驗的主題。我們對 STELLAR-303 在 CRC 中取得的正面頂線結果感到滿意，並期待與監管機構合作，以盡快申請該適應症的批准。STELLAR-304 在非透明細胞 RCC 的研究已完全入組，並將繼續推進，預計在 2026 年上半年獲得頂線結果，具體取決於事件發生率。

Based on evaluation of the data from STELLAR-305 in head and neck cancer and the competition in the indication, we made the decision to not advance this trial into Phase III. This decision was further supported by our assessment of the commercial opportunity of new zanza indications on the horizon that we believe have a higher probability of success, little to no competition and potentially an approximate threefold greater commercial value than the STELLAR-305 opportunity.

根據 STELLAR-305 在頭頸癌治療中的數據以及適應症競爭情況的評估，我們決定不將該試驗推進到 III 期。這項決定得到了我們對即將出現的新的 zanza 適應症的商業機會的評估的支持，我們認為這些新適應症具有更高的成功機率、幾乎沒有競爭，並且潛在的商業價值比 STELLAR-305 機會高出約三倍。

As we've highlighted previously, we stand ready to make tough, decisive capital allocation decisions based on clinical and competitive data and in-depth financial analysis. We're doing it now for STELLAR-305, and you can expect the same level of rigor from us in the future across all components of the business. We continue to prioritize existing and new zanza indications as the most promising path to a second Exelixis oncology franchise that we believe can eclipse the size, scope and impact of our cabozantinib franchise.

正如我們之前所強調的那樣，我們隨時準備根據臨床和競爭數據以及深入的財務分析做出艱難、果斷的資本配置決策。我們現在正在為 STELLAR-305 做這件事，未來我們將在業務的所有組成部分中保持相同的嚴謹程度。我們繼續優先考慮現有和新的 zanza 適應症，將其作為獲得第二個 Exelixis 腫瘤學特許經營權的最有希望的途徑，我們相信該特許經營權可以超越我們的卡博替尼特許經營權的規模、範圍和影響。

Third, Exelixis early-stage pipeline is advancing quickly with a range of new and potentially differentiated biologics and small molecule moving into and through early clinical evaluation. As I highlighted last quarter, we're not looking to just build a big pipeline but carefully and quickly identify the winners for advancement into full development as top investment priorities. Early evaluation of XL309 and XB010 continue to advance quickly, and we're pleased to have the specific XB628 and our second-generation tissue factor targeting ADC, XB371, moving into the clinic.

第三，Exelixis 的早期產品線正在快速推進，一系列新的、具有潛在差異化的生物製劑和小分子正在進入並通過早期臨床評估。正如我在上個季度所強調的那樣，我們並不只是想建立一個龐大的管道，而是要仔細、快速地找出獲勝者，並將其作為首要投資重點，推動全面發展。XL309 和 XB010 的早期評估繼續快速推進，我們很高興特定的 XB628 和我們的第二代組織因子靶向 ADC XB371 進入臨床。

Finally, we remain committed to carefully managing capital allocation while we advance our R&D and commercial priorities. Our balance sheet and expected free cash flow provide us with the opportunity to advance our pipeline priorities access new high-conviction assets and continue to repurchase shares when we believe they are undervalued. Business development activities continue in earnest, and we're focused on doing the right deals for the right assets at the right valuations.

最後，在推動研發和商業重點的同時，我們仍致力於謹慎管理資本配置。我們的資產負債表和預期的自由現金流為我們提供了機會，可以推進我們的管道優先事項，獲得新的高信念資產，並在我們認為股票被低估時繼續回購股票。業務發展活動繼續認真進行，我們專注於以正確的估值為正確的資產進行正確的交易。

So with that, please see our press release issued an hour ago for our second quarter 2025 financial results and an extensive list of key corporate milestones achieved in the quarter. And I'll now turn the call over to Chris.

因此，請參閱我們一小時前發布的新聞稿，以了解我們的 2025 年第二季財務業績以及本季度實現的關鍵公司里程碑的詳盡清單。現在我將把電話轉給克里斯。

Thanks, Mike. For the second quarter 2025, the company reported total revenues of approximately $568 million which included cabozantinib franchise net product revenues of $520 million. CABOMETYX net product revenues were $518 million and included approximately $600,000 in clinical trial sales, which is significantly lower than the $12 million of clinical trial sales we had in the first quarter of 2025.

謝謝，麥克。2025 年第二季度，該公司報告總收入約為 5.68 億美元，其中包括 5.2 億美元的卡博替尼特許經營淨產品收入。CABOMETYX 淨產品收入為 5.18 億美元，其中包括約 60 萬美元的臨床試驗銷售額，遠低於 2025 年第一季的 1,200 萬美元臨床試驗銷售額。

As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future. Gross-to-net cabozantinib franchise in the second quarter of 2025 was 30.2% which is higher than the-gross-to net we experienced in the first quarter of 2025. This increase in gross-to-net deductions in the second quarter 2025 is primarily related to higher 340B volume in the quarter. Over the past several quarters, we have experienced a continued increase in the percentage of our business that is related to 340B volume, which is now over 24% of our total volume, which when compared to the second quarter of 2024 is 4 percentage points higher.

需要繼續提醒的是，臨床試驗的銷售在各個季度之間歷來波動較大，我們預計這種情況將持續到未來。2025 年第二季卡博替尼的毛利率為 30.2%，高於 2025 年第一季的毛利率。2025 年第二季總扣除額至淨扣除額的增加主要與該季度 340B 交易量的增加有關。在過去的幾個季度中，我們與 340B 交易量相關的業務比例持續增長，目前已占我們總交易量的 24% 以上，與 2024 年第二季度相比高出 4 個百分點。

Trade inventory at the end of the second quarter 2025 was approximately 2.2 weeks on hand, which was higher when compared to the first quarter 2025. The increase in trade inventory weeks on end was partially due to the timing of the July 4 holiday week, which had lower volume than the preceding four weeks. Total revenues also included approximately $48.2 million in collaboration revenues, which includes approximately $43.4 million in royalties earned from our partners Ipsen and Takeda on their sales of cabozantinib in their respective territories.

2025 年第二季末的貿易庫存約為 2.2 週，與 2025 年第一季相比有所上升。貿易庫存連續數週增加的部分原因是 7 月 4 日是假期週，該週的庫存量低於前四周。總收入還包括約 4,820 萬美元的合作收入，其中包括我們的合作夥伴益普生和武田在其各自地區銷售卡博替尼所獲得的約 4,340 萬美元的特許權使用費。

Our total operating expenses for the second quarter of 2025 was $355 million compared to $369 million in the first quarter of 2025. The sequential decline in these operating expenses was primarily driven by lower manufacturing cost for drug development candidates, lower clinical trial costs and lower general and administrative costs. Provision for income taxes for the second quarter of 2025 was approximately $45.6 million compared with a provision for income taxes of approximately $46.1 million for the first quarter of 2025.

我們 2025 年第二季的總營運費用為 3.55 億美元，而 2025 年第一季為 3.69 億美元。這些營運費用的連續下降主要是由於藥物開發候選物的製造成本降低、臨床試驗成本降低以及一般和行政成本降低。2025 年第二季的所得稅準備金約為 4,560 萬美元，而 2025 年第一季的所得稅準備金約為 4,610 萬美元。

Additionally, the One Big Beautiful Bill Act was signed into law on July 4, 2025, which, among other provisions, permanently repeals the requirement to capitalize domestic R&D expenses for federal income tax purposes for taxable years beginning after December 31, 2024 and allows for the accelerated deduction of any remaining unamortized domestic R&D expenditures. Foreign R&D expenditures are still required to be capitalized and amortized ratably over 15 years. The federal cash tax benefit for previously unamortized domestic R&D expenditures is estimated at $147 million with no corresponding impact to the federal income tax provision.

此外，《一項偉大的美麗法案》於 2025 年 7 月 4 日簽署成為法律，其中除其他條款外，永久廢除了在 2024 年 12 月 31 日之後開始的納稅年度中將國內研發費用資本化以用於聯邦所得稅的要求，並允許加速扣除任何剩餘的未攤銷的國內研發支出。國外研發支出仍需資本化，並以15年按比例攤銷。先前未攤銷的國內研發支出的聯邦現金稅收優惠估計為 1.47 億美元，對聯邦所得稅規定沒有相應影響。

The company reported GAAP net income of approximately $184.8 million or $0.68 per share basic and $0.65 per share diluted for the second quarter of 2025. The company also reported non-GAAP net income of approximately $212.6 million or $0.78 per share basic and $0.75 per share diluted. Non-GAAP net income excludes the impact of approximately $28 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the quarter ended June 30, 2025 were approximately $1.4 billion.

該公司報告稱，2025 年第二季 GAAP 淨收入約為 1.848 億美元，即每股基本淨收入 0.68 美元，每股攤薄淨收入為 0.65 美元。該公司還報告非公認會計準則淨收入約為 2.126 億美元，即每股基本收入 0.78 美元，每股攤薄收入為 0.75 美元。非公認會計準則淨收入不包括約 2,800 萬美元的股票薪資費用扣除相關所得稅的影響。截至 2025 年 6 月 30 日的季度現金和有價證券約為 14 億美元。

During the second quarter of 2025, we repurchased approximately $302 million of the company's shares, resulting in the retirement of approximately $7.5 million of the company's shares at an average price per share of $40.10. As of the end of the second quarter of 2025, we had approximately $204 million remaining under the $500 million stock repurchase plan authorized by the company's board in February 2025.

2025年第二季度，我們回購了約3.02億美元的公司股票，導致約750萬美元的公司股票以每股40.10美元的平均價格退出市場。截至2025年第二季末，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，我們剩餘約2.04億美元。

And finally, we will continue to evaluate further updates to our 2025 financial guidance as we build momentum on the NET launch and gain further clarity on additional revenue opportunities for the second half of 2025. We are reiterating our full year 2025 financial guidance, which is detailed on slide 14 of our earnings presentation.

最後，隨著 NET 發布的勢頭增強，並進一步明確 2025 年下半年的額外收入機會，我們將繼續評估 2025 年財務指導的進一步更新。我們重申 2025 年全年財務指導，該指導在我們的收益報告第 14 張幻燈片中有詳細說明。

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

說完這些，我將把電話轉給 PJ。

Thank you, Chris. The CABOMETYX business was very strong in the second 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. 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+IO combination in first-line RCC.

謝謝你，克里斯。2025 年第二季度，CABOMETYX 業務表現非常強勁。重要的是，神經內分泌腫瘤領域的研發取得了良好的開端。Cabo 在收入、需求和新患者數量方面持續呈現成長，並且相對於競爭對手錶現尤為出色。該團隊繼續以極高的水平執行，CABOMETYX 繼續成為腎細胞癌中處方量第一的 TKI，以及第一線 RCC 中第一的 TKI+IO 組合。

The commercial team is delivering on the launch in NETs with great urgency, with the goal to rapidly establish CABOMETYX as a small molecule market leader in the NET space. We are pleased that prescribers are responding positively to the data and are excited to have a new therapy available to unmet need in neuroendocrine tumors as we look to build on the strong momentum of the CABOMETYX business.

商業團隊正緊急推動 NET 的上市工作，目標是迅速將 CABOMETYX 打造為 NET 領域小分子市場的領導者。我們很高興看到處方醫生對數據做出了積極的反應，並且很高興能夠有一種新的治療方法來滿足神經內分泌腫瘤中未滿足的需求，因為我們希望在 CABOMETYX 業務強勁勢頭的基礎上再接再厲。

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. Looking at the TRx comparison of Q2 2024 to Q2 2025, CABOMETYX grew 4 share points from 41% to 45%. CABOMETYX TRx volume grew 18% in this time period, outpacing the growth rate of the market by 10 percentage points.

卡波替尼、侖伐替尼、阿昔替尼、舒尼替尼和帕唑帕尼的口服 TKI 市場處方數據顯示了卡波替尼相對於競爭對手的實力。從 2024 年第二季與 2025 年第二季的 TRx 比較來看，CABOMETYX 的市佔率成長了 4 個百分點，從 41% 成長至 45%。在此期間，CABOMETYX TRx 的銷售量成長了 18%，超過市場成長率 10 個百分點。

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. We're able to discuss both the CABO-NET data as well as the RCC CheckMate -9ER five-year follow-up data with relevant physicians. These -9ER data presented at GU ASCO in February, resonate with prescribers in the RCC base and help our team continue to drive differentiation from the competition in the first-line RCC market.

重要的是，CABOMETYX RCC 業務仍然強勁且持續成長。針對先前治療過的 NET 的新適應症為我們經驗豐富的銷售團隊提供了接觸客戶的便利性。我們可以與相關醫師討論 CABO-NET 資料以及 RCC CheckMate -9ER 五年追蹤資料。這些在二月的 GU ASCO 上展示的 -9ER 數據引起了 RCC 基地處方者的共鳴，並幫助我們的團隊繼續在 RCC 一線市場中保持與競爭對手的差異化。

Turning to neuroendocrine tumors, we are thrilled that the launch is off to such a strong start. The team has been working tirelessly to execute tactics across channels and customer segments since approval, including personal promotion, targeted nonpersonal digital and social media tactics, peer-to-peer education, a comprehensive patient-support program, as well as patient and allied healthcare professional education. The team is working to rapidly establish CABOMETYX as a new standard of care in second-line-plus NET patients.

談到神經內分泌腫瘤，我們很高興看到該產品的發布有如此強勁的開端。自從獲得批准以來，該團隊一直不懈地努力在各個管道和客戶群中實施策略，包括個人推廣、有針對性的非個人數位和社交媒體策略、點對點教育、全面的患者支持計劃以及患者和相關醫療專業人員教育。該團隊正在努力迅速將 CABOMETYX 確立為第二線及以上 NET 患者的新照護標準。

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 favorably to the broad NET label in the contemporary trial design and perceive the efficacy and tolerability of the cabo data is favorable relative to other small molecule therapies in the space. Prescribers envision 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.

我們的市場研究和客戶回饋表明，處方醫生對神經內分泌腫瘤患者的新治療選擇感到非常興奮，這是九年來第一種廣泛應用的新型口服小分子療法。醫生對當代試驗設計中的廣泛 NET 標籤反應良好，並認為 cabo 數據的有效性和耐受性相對於該領域的其他小分子療法更為有利。處方人員設想根據患者和腫瘤特徵廣泛使用 cabo，包括患有胰腺、胃腸道和肺部神經內分泌腫瘤的患者（所有腫瘤等級、功能性和 SSTR 狀態），以及曾接受過 Lutathera 治療的患者。

As we look at early utilization in our market research, we are pleased to see the positive perception data from prescribers. We're seeing rapid uptake of CABOMETYX in both second- and third-line NETs across all the relevant patient and tumor characteristics. Encouragingly, this uptake is similar in both academic and community settings. The launch in NETs is both expanding our prescriber base and increasing prescriptions for legacy cabo prescribers.

當我們在市場研究中觀察早期利用情況時，我們很高興看到處方者的正向感知數據。我們看到 CABOMETYX 在所有相關患者和腫瘤特徵的二線和三線 NET 中的快速吸收。令人鼓舞的是，學術界和社區環境中的這種接受度是相似的。NET 的推出不僅擴大了我們的處方醫生基礎，還增加了傳統 Cabo 處方醫生的處方量。

Turning to the new-patient market share for second-line-plus neuroendocrine tumors in Q2, we are pleased that CABOMETYX has rapidly become the market leader in the segment with approximately 35% new patient share for oral therapies. This share is very encouraging so early in the launch, as CABOMETYX was approved on March 26. Hence, we believe that new patient share should continue to increase and, importantly, patients will have the opportunity to benefit from being prescribed this therapy.

談到第二季二線以上神經內分泌腫瘤的新患者市場份額，我們很高興看到 CABOMETYX 迅速成為該領域的市場領導者，口服療法的新患者份額約為 35%。由於 CABOMETYX 於 3 月 26 日獲得批准，因此在上市初期就取得這樣的成績非常令人鼓舞。因此，我們相信新患者的比例應該會繼續增加，而且重要的是，患者將有機會從這種療法中受益。

Over time, as more patients start therapy with cabo and receive refills, we believe demand will continue to increase. Neuroendocrine demand contributed just over 4% of total demand for cabo in Q2, and we expect that contribution to increase going forward.

隨著時間的推移，隨著越來越多的患者開始接受卡波治療並獲得補充，我們相信需求將會持續增加。神經內分泌需求在第二季度佔 cabo 總需求的 4% 多一點，我們預計這項貢獻未來將會增加。

Finally, the second quarter market research indicated that CABOMETYX was viewed as the best-in-class oral therapy in neuroendocrine tumors. We are pleased that this perception was achieved so rapidly after the approval. This perception is typically a leading indicator of prescribing behavior which 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，第二季的市場研究表明，CABOMETYX 被視為神經內分泌腫瘤領域最佳的口服療法。我們很高興看到這項認知在批准後如此迅速地形成。這種看法通常是處方行為的領先指標，這使我們相信 CABOMETYX 新患者市場份額將在未來幾季繼續增加。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，其中許多客戶表示，一旦 NET 患者病情惡化並需要不同的全身治療，他們就會為他們開立卡波藥。

Taken together, the data and customer feedback give us a high degree of confidence in the growth of CABOMETYX in neuroendocrine tumors. As this can be a more indolent tumor type, new patient starts for cabo are governed by patients progressing on their current therapy.

綜合起來，數據和客戶回饋使我們對 CABOMETYX 在神經內分泌腫瘤中的生長充滿信心。由於這可能是一種較為惰性的腫瘤類型，因此接受 cabo 治療的新患者取決於其目前治療的進展。

In closing, we are excited by this opportunity to serve NET patients, and our enthusiasm is matched by physicians’ excitement to have a new and effective option for their patients. In general, prescribers see CABOMETYX is 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 to support the launch. All of this taken together drives our conviction that the NET market will be a substantial opportunity for the CABOMETYX business.

最後，我們很高興有機會為 NET 患者提供服務，我們的熱情與醫生們為患者提供新的有效選擇的興奮之情不謀而合。總體而言，處方醫生認為 CABOMETYX 是比其他先前批准的小分子療法更有利的選擇。此外，網路市場口服藥物領域的競爭主要是仿製藥，這使得 CABOMETYX 擁有顯著優勢，並擁有一個完整的商業組織來支持該產品的推出。所有這些因素共同促使我們堅信，NET 市場將為 CABOMETYX 業務帶來巨大的機會。

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

說完這些，我會把電話轉給艾米。

Thanks, PJ. Starting first with STELLAR-303. On June 22, we announced positive topline results in which the combination of zanzalintinib plus atezolizumab demonstrated a statistically significant improvement in overall survival versus regorafenib in the intent-to-treat or ITT population.

謝謝，PJ。首先從 STELLAR-303 開始。6 月 22 日，我們公佈了積極的頂線結果，其中 zanzalintinib 加 atezolizumab 的組合在意向治療或 ITT 人群中與瑞戈非尼相比，總體生存率有統計學上顯著改善。

As a reminder, STELLAR-303 is our Phase III study comparing zanzalintinib plus atezolizumab to regorafenib in patients who have received multiple prior therapies for their advanced colorectal cancer. The trial has dual primary endpoints designed to assess survival outcomes more broadly in the ITT population and, more specifically, in the population of patients without liver metastases, referred to as NLM

提醒一下，STELLAR-303 是我們進行的一項 III 期研究，該研究比較了 zanzalintinib 加 atezolizumab 與瑞戈非尼在已接受過多種晚期結直腸癌治療的患者中的療效。該試驗有兩個主要終點，旨在更廣泛地評估 ITT 族群的生存結果，更具體地說，是評估無肝轉移患者群體（稱為 NLM）的生存結果

Secondary endpoints of STELLAR-303 include progression-free survival in the ITT and NLM subgroup of patients as well as overall survival and progression-free survival in the subgroup of patients with liver metastases. These topline results represent the final OS analysis in the ITT and the trial will proceed to the planned final analysis of the other dual primary endpoint of OS in the NLM patient population, the timing of which is event-driven.

STELLAR-303 的次要終點包括 ITT 和 NLM 患者亞組的無惡化存活期以及肝轉移患者亞組的總存活期和無惡化存活期。這些頂線結果代表了 ITT 中的最終 OS 分析，並且試驗將繼續進行 NLM 患者群體中 OS 的另一個雙重主要終點的計劃最終分析，其時間由事件驅動。

It's worth highlighting that this is the first IO-TKI combination to show a statistically significant survival benefit in a broad population and against an active standard-of-care control arm. We plan to discuss these positive data with regulators with the intention to file a new drug application. We also look forward to sharing these results at an upcoming medical conference, and we'll be more specific when abstract titles become available.

值得強調的是，這是第一個在廣泛人群中和相對於活性標準治療對照組顯示出統計上顯著生存益處的 IO-TKI 組合。我們計劃與監管機構討論這些積極數據，以提交新藥申請。我們也期待在即將舉行的醫學會議上分享這些結果，當摘要標題公佈時，我們會更具體地說明。

STELLAR-304 is our pivotal study evaluating the combination of zanzalintinib plus nivolumab versus sunitinib in patients who have not yet received systemic therapy for their locally advanced or metastatic non-clear cell RCC. Based on the current event rate, we are now anticipating topline results in the first half of 2026.

STELLAR-304 是我們的關鍵研究，評估了 zanzalintinib 加 nivolumab 與舒尼替尼聯合治療尚未接受局部晚期或轉移性非透明細胞 RCC 全身治療的患者的效果。根據目前的事件發生率，我們預計 2026 年上半年將出現頂線結果。

So let's go next to STELLAR-305. Our Phase II/III study comparing zanzalintinib plus pembrolizumab to placebo plus pembrolizumab in patients who have not yet received systemic treatment for their advanced PD-L1 expressing squamous cell carcinoma of the head and neck. As Mike said in his opening remarks, we have made the decision not to proceed into the Phase III portion of the trial and are in the process of study closeout. We will share data at a future time and are shifting our focus into new development opportunities for zanzalintinib.

接下來我們來看看 STELLAR-305。我們的 II/III 期研究比較了 zanzalintinib 加 pembrolizumab 與安慰劑加 pembrolizumab 在尚未接受全身治療的晚期 PD-L1 表達頭頸部鱗狀細胞癌患者中的療效。正如麥克在開場白中所說，我們決定不再進行第三階段的試驗，目前正處於研究結束階段。我們將在未來共享數據，並將重點轉向 zanzalintinib 的新發展機會。

Speaking of which, I'd like to now turn to our first pivotal trial evaluating zanzalintinib as monotherapy. I'm pleased to announce the initiation of STELLAR-311, which will compare zanzalintinib to everolimus as a first oral therapy in patients with neuroendocrine tumors. We're also excited about the recent initiation of the zanzalintinib plus belzutifan cohorts in the Phase II umbrella study being conducted by Merck.

說到這，我現在想談談我們評估 zanzalintinib 作為單一療法的第一個關鍵試驗。我很高興地宣布啟動 STELLAR-311 研究，該研究將比較 zanzalintinib 與依維莫司作為神經內分泌腫瘤患者的首個口服療法。我們也對默克公司最近啟動的 zanzalintinib 加 belzutifan 隊列 II 期傘狀研究感到興奮。

In this study, the combination of belzutifan plus zanzalintinib is being tested in patients with previously treated metastatic clear cell carcinoma. Progress also continues with regard to the two pivotal studies that Merck is running in clear cell carcinoma evaluating zanzalintinib in combination with belzutifan, and we anticipate these studies could start towards the end of 2025.

在這項研究中，正在對先前接受過治療的轉移性透明細胞癌患者進行 Belzutifan 與 zanzalintinib 聯合治療的測試。默克公司在透明細胞癌領域進行的兩項關鍵研究也持續取得進展，評估 zanzalintinib 與 belzutifan 的聯合治療效果，我們預計這些研究將於 2025 年底開始。

As we think about the aforementioned studies representing Wave 1 in the zanzalintinib development program, I want to convey that we are moving full steam ahead into Wave 2 pivotal trial planning to continue building on the franchise. In light of the positive data from STELLAR-303 in metastatic colorectal cancer, we are considering how best to zanzalintinib earlier into the CRC-treatment landscape. We're specifically investigating the post-adjuvant setting where patients have received maximal care with surgery and, in many cases chemotherapy, yet still have a high risk of recurrence.

當我們思考上述代表 zanzalintinib 開發計劃第 1 波的研究時，我想表達的是，我們正在全力推進第 2 波關鍵試驗計劃，以繼續鞏固特許經營權。鑑於 STELLAR-303 在轉移性結直腸癌治療中取得的積極數據，我們正在考慮如何最好地將 zanzalintinib 更早應用於 CRC 治療領域。我們正在專門研究輔助治療後的情況，患者雖然接受了手術等最大程度的治療，並且在許多情況下接受了化療，但仍然有很高的復發風險。

These patients have nothing else available to them. The only option available being frequent scanning and basically entering a watch-and-wait period until a distant or local recurrence is found at which point they are mostly rendered incurable. Given the profile of zanzalintinib and its ability to inhibit targets like MET and VEGF, well known for their role in metastatic spread and local establishment of tumor growth, we believe there is reasonable probability that treatment with zanzalintinib could lower these patients' risks of recurrence, improving disease-free survival and unmet need in this setting.

這些病人沒有其他可用的治療手段。唯一可用的選擇是頻繁掃描並基本上進入觀察等待期，直到發現遠處或局部復發，此時它們大多無法治癒。鑑於 zanzalintinib 的特性及其抑制 MET 和 VEGF 等靶點的能力（眾所周知，它們在轉移擴散和腫瘤生長局部建立中起著重要作用），我們相信，使用 zanzalintinib 治療可以降低這些患者的複發風險，從而提高無病生存率並滿足此類情況下的未滿足需求。

There's also interesting data coming out of an IST investigating cabozantinib in patients with high-grade and/or recurrent meningiomas, where the only treatment options are surgery and radiation. Given their central location, neither of these modalities are considered optimal salvage modalities. Offering patients an oral agent like zanzalintinib that could impair further growth and potentially reduce tumor size could represent a breakthrough in the treatment paradigm.

一項 IST 研究了卡博替尼對高級別和/或復發性腦膜瘤患者的作用，得出了有趣的數據，這些患者唯一的治療選擇是手術和放射治療。鑑於其中心位置，這兩種方式都不是最佳的救援方式。為患者提供像贊扎林替尼這樣的口服藥物，可以抑制腫瘤的進一步生長，並可能縮小腫瘤的大小，這可能代表治療模式的突破。

We will continue to assess the landscape to consider other areas where zanzalintinib could be developed, leveraging data from our cabozantinib experience as well as emerging data from our ongoing clinical trials. I look forward to sharing more details of these important opportunities that we believe could enhance the reach of zanzalintinib when we are closer to launching those studies.

我們將繼續評估情勢，考慮可以開發 zanzalintinib 的其他領域，利用我們在卡博替尼方面的經驗數據以及我們正在進行的臨床試驗中出現的數據。我期待著在我們接近啟動這些研究時分享這些重要機會的更多細節，我們相信這些機會可以擴大 zanzalintinib 的影響力。

I'll now turn the call over to Dana.

我現在將電話轉給達娜。

Thanks Amy, and good afternoon, everyone. Today, I'm giving a brief update on our recent progress regarding the early clinical compounds in our pipeline, new IND filings and advancing new compounds to development candidate status.

謝謝艾米，大家下午好。今天，我將簡要介紹我們近期在早期臨床化合物、新的 IND 申請以及將新化合物推進到開發候選狀態方面的進展。

Regarding the early clinical pipeline, our most advanced molecules in this space are XL309, our selective inhibitor of USP1, and XB010, our 5T4-targeting-antibody drug conjugate. Both of which have first-in-class potential. The Phase I studies for both compounds have been progressing well. And importantly, in patients, both compounds have achieved exposures that are associated with efficacy in preclinical human tumor xenograft models in mice. We've also made good progress in the Phase I study for XB628, our bispecific antibody targeting PD-L1 and NKG2A.

關於早期臨床管線，我們在該領域最先進的分子是XL309（我們的USP1選擇性抑制劑）和XB010（我們的5T4標靶抗體藥物偶聯物）。兩者都具有一流的潛力。這兩種化合物的第一階段研究進展順利。重要的是，在患者中，這兩種化合物都達到了與小鼠臨床前人類腫瘤異種移植模型中的療效相關的暴露量。我們的 PD-L1 和 NKG2A 的雙特異性抗體 XB628 的 I 期研究也取得了良好進展。

Despite filing the IND for XB628 so recently, we have already seen brisk enrollment in this Phase I trial, reflecting a high degree of enthusiasm at the clinical sites for this novel molecule. On the new IND front, in the second quarter, we filed our second IND this year, which is for XB371, our tissue-factor-targeting ADC that carries the topoisomerase inhibitor payload. XB371 has a nominal drug-to-antibody ratio, or DAR, of eight, and utilizes smart-tech technology that employs a site-specific conjugation of the linker payload to the antibody which, among other benefits, increases control over the DAR species during manufacturing.

儘管最近才提交 XB628 的 IND，但我們已經看到該 I 期試驗的招募情況十分活躍，反映出臨床試驗點對這種新型分子的高度熱情。在新的 IND 方面，我們在第二季度提交了今年的第二個 IND，該 IND 是針對 XB371 的，這是我們的組織因子靶向 ADC，攜帶拓撲異構酶抑製劑有效載荷。XB371 的標稱藥物與抗體比率 (DAR) 為 8，並利用智慧技術將連接體有效載荷與抗體進行位點特異性結合，除其他優點外，還增加了對製造過程中 DAR 種類的控制。

The technology also takes a belt-and-suspenders approach to prevent inappropriate payload release outside of the tumor by utilizing a dual-tandem cleavage mechanism that occurs inside the tumor cells, first bi-glucuronidase enzyme, which then exposes a protease site for the ultimate release of the free payload from the antibody. Our presentation at AACR this year showed deep and durable regressions of human colorectal, lung and pancreatic xenograft tumors in mice after a single dose of XB371, underscoring the significant potential for this molecule to address unmet need. The team is excited to now be focused on enrolling the Phase I clinical trial for this molecule.

該技術還採取了雙重保險的方法來防止腫瘤外部不適當的有效載荷釋放，即利用腫瘤細胞內部發生的雙串聯裂解機制，首先是雙葡萄醣醛酸酶，然後暴露蛋白酶位點，最終從抗體中釋放出遊離有效載荷。我們今年在 AACR 上的報告顯示，小鼠單劑量服用 XB371 後，人類結腸直腸癌、肺癌和胰腺異種移植腫瘤出現深度和持久的消退，這凸顯了這種分子在滿足未滿足需求方面的巨大潛力。該團隊很高興現在專注於進行該分子的 I 期臨床試驗。

In terms of new development candidates, we are continuing to advance exciting new programs, including some innovative small molecules and antibody drug conjugates, and I look forward to sharing more details about those programs at the R&D Day event later this year.

在新的開發候選藥物方面，我們正在繼續推進令人興奮的新項目，包括一些創新的小分子和抗體藥物偶聯物，我期待在今年稍後的研發日活動上分享有關這些項目的更多細節。

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

因此，我將把電話轉回給麥克。

All right. Thanks, Dana. We'll wrap up here with a big thank you to the Exelixis team for helping make our second quarter so successful. As you've heard me say previously, we work in a tough business, and I'm pleased to see our resilience and drive as we progress important projects across our discovery, development and commercial activities in the first half of 2025.

好的。謝謝，達娜。最後，我們要向 Exelixis 團隊表達衷心的感謝，感謝他們幫助我們取得了第二季的成功。正如您之前聽到我所說的那樣，我們從事的是一項艱苦的行業，我很高興看到我們在 2025 年上半年推進發現、開發和商業活動中的重要項目時所展現的韌性和動力。

As we said last quarter, we're never satisfied or content with the status quo and look to improve our efficiency and performance on a daily basis as we make every hour count to excel on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future.

正如我們上個季度所說的那樣，我們永遠不會滿足於現狀，並希望每天提高我們的效率和績效，因為我們會讓每一小時都發揮作用，出色地完成我們的使命，幫助癌症患者恢復得更強，活得更長。我們期待在未來向您通報我們的進展。

Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

感謝您對 Exelixis 的持續支持和關注，我們很高興現在開始回答問題。

(Operator Instructions)

（操作員指示）

David Lebowitz, Citi.

花旗銀行的 David Lebowitz。

Thank you very much for taking my question. I know it's early, and we haven't really seen the data yet, but any particular takeaways that we have from head and neck that can be extrapolated or not extrapolated to future studies?

非常感謝您回答我的問題。我知道現在還為時過早，我們還沒有真正看到數據，但是我們從頭部和頸部得到的任何具體結論是否可以推斷或不推斷到未來的研究中？

Amy?

艾米？

Yeah, thanks for the question. So let me just back up a second and remind everybody: zanzalintinib is a franchise molecule, and there's much more to be done than what we have contemplated in the initial six pivotal trials that we've been discussing. Rigorous drug development requires continuous assessments of internally and externally emerging data, and we have multiple areas to continue developing in. We're not going to share any of the data at this point in time, but we will share it with you at a future point.

是的，謝謝你的提問。因此，讓我稍微回顧一下並提醒大家：zanzalintinib 是一種特許經營分子，我們要做的事情比我們在討論的最初六個關鍵試驗中所考慮的要多得多。嚴格的藥物開發需要不斷評估內部和外部出現的數據，我們有多個領域需要繼續發展。我們目前不會分享任何數據，但我們將在將來與您分享。

Sean Laaman, Morgan Stanley.

摩根士丹利的肖恩拉曼。

Thank you. Hi, Mike and team. Hope everyone's well. Just thinking a little bit longer term, the $3 billion peak revenue guidance for CABO, it looks like, I think, looking at guidance for this year, probably do around about 2.1 ex-NET and other revenue opportunities. Just looking at the market share gains you had, I'm just wondering sort of how enduring do you think such share gains can be? And the second part would be, do you think you can achieve the same market share in NET as what you've seen in RCC?

謝謝。嗨，麥克和他的團隊。希望大家一切安好。只是稍微考慮一下長期來看，CABO 30 億美元的高峰收入指導，我認為，看看今年的指導，大概會在 2.1 左右（不包括 NET 和其他收入機會）。僅從您所獲得的市場份額增長來看，我只是想知道您認為這種份額增長能夠持續多久？第二部分是，您認為您可以在 NET 上取得與 RCC 相同的市場份額嗎？

Yeah, why don't I start with that, and I'll pass it off to PJ for some color commentary. So we have built a very strong franchise with cabo over the years, seeing consistent growth in market share and revenue. First, in the RCC realm with what we've been focused primarily with 9ER and then having that data propel us forward over the last four or five years of market share growth.

是的，我為什麼不從那裡開始呢，然後我會把它交給 PJ 來做一些彩色評論。因此，多年來我們與 cabo 建立了非常強大的特許經營權，市場份額和收入持續成長。首先，在 RCC 領域，我們主要關注 9ER，而這些數據推動我們在過去四、五年內實現市場份額成長。

I think as PJ mentioned, year over year, Q2 '24 to Q2 '25, we saw 4 points of market share growth well into the launch, which underscores our ability to commercialize and generate and at least talk about new data from existing trials that help us frame the opportunity for patients. And we think we can do exactly the same thing in the NET space. So again, we have one quarter behind us now with NET. 35% market share is a great place to start. Best-in-class in the oral therapy is a great place to start both within literally months of launching the drug post-approval.

我認為，正如 PJ 所提到的那樣，與去年同期相比，從 2024 年第二季度到 2025 年第二季度，我們的市場份額在推出後增長了 4 個百分點，這凸顯了我們商業化和生成新數據的能力，至少可以談論現有試驗中的新數據，這有助於我們為患者創造機會。我們認為我們可以在 NET 空間做同樣的事情。因此，我們現在已經利用 NET 取得了一個季度的成績。 35% 的市佔率是一個很好的起點。在藥物獲批上市後的幾個月內，口服療法領域的一流水平是一個很好的起點。

So early days, we're very excited. As you I'm sure you're aware, Sean, first quarter is usually the NPS quarter where new patients come on, and you start to stack with refills later as you're growing NPS. So we're very excited, and I think very confident that we can continue to drive the business forward by growing the base business driven by RCC and then this NET opportunity, which we think is large and substantial going forward.

所以在早期階段，我們非常興奮。肖恩，我相信您知道，第一季通常是 NPS 季度，新患者會隨之而來，隨著 NPS 的增長，您會開始陸續收到補充藥物。因此，我們非常興奮，並且我非常有信心，我們可以透過發展由 RCC 驅動的基礎業務以及這個 NET 機會來繼續推動業務向前發展，我們認為這個 NET 機會在未來將是巨大而實質性的。

PJ, any comments?

PJ，有什麼意見嗎？

Yeah, thanks Mike. Slight color maybe on the net launch beyond that. As I said, we're certainly pleased with RCC - that continues to grow. But in terms of NET, very early innings.

是的，謝謝邁克。除此之外，網路上可能會出現輕微的色彩。正如我所說，我們對 RCC 感到非常滿意 - 它的持續增長。但就 NET 而言，這局比賽還很早。

We really are excited by the 35% share growth in the second-line-plus oral market. That's just really strong for the first few months of launch. And I think importantly, as we look beyond that, the fact that we're already seen as the best-in-class oral therapy in neuroendocrine tumors, that's really great that we've done it so quickly, and our research actually indicates it's not even close - sort of well out in front of the pack there. And that's important because that's a metric that is typically a leading indicator of physician behavior.

我們對二線及以上口服藥物市場佔有率 35% 的成長感到非常興奮。對於發布後的頭幾個月來說，這確實很強勁。我認為重要的是，當我們放眼未來時，我們已經被視為神經內分泌腫瘤領域一流的口服療法，我們如此迅速地取得進展真是太棒了，我們的研究實際上表明它甚至還沒有接近 - 在某種程度上處於領先地位。這很重要，因為這是一個通常作為醫生行為領先指標的指標。

So kind of as I mentioned in my prepared remarks, we really do think that we'll continue to increase in new patient market share there. And as Mike kind of mentioned, first quarters of launch, you're getting a lot of new patients on therapy, and it takes time to really get the benefit of refills for those patients. We anticipate that as patients continue to come on therapy, and we have more and more patients on therapy, we'll start to sort of stack those refills driving demand.

正如我在準備好的演講中提到的那樣，我們確實認為我們將繼續增加那裡的新患者市場份額。正如麥克所提到的那樣，在推出後的頭幾個季度，您會收到許多接受治療的新患者，而這些患者真正從補充藥物中獲益需要時間。我們預計，隨著患者繼續接受治療，並且接受治療的患者越來越多，我們將開始堆積這些補充藥物來推動需求。

And finally, I mentioned that this is a more indolent disease. So a lot of what we're seeing and hearing from our sales force, advisory boards, et cetera, is physicians really like the data. They have patients on other therapies and neuroendocrine tumors who are stable, and when those patients progress and need another therapy, they're planning on using cabo for that choice.

最後，我提到這是一種較為緩慢的疾病。因此，我們從銷售人員、顧問委員會等看到和聽到的許多資訊是，醫生真的很喜歡這些數據。他們有接受其他療法且神經內分泌腫瘤穩定的患者，當這些患者的病情惡化並需要其他療法時，他們計劃使用卡波作為選擇。

But obviously, it's great if patients are stable with metastatic cancer. And so, there is an element of time that we need kind of the growth governed by patients coming off therapy. But we anticipate all these dynamics giving us really strong growth in NETs going forward.

但顯然，如果患者的轉移性癌症病情穩定，那就太好了。因此，我們需要根據患者結束治療的情況來控制其成長時間。但我們預計所有這些動態都會為我們未來的 NET 帶來真正強勁的成長。

Michael Schmidt, Guggenheim.

古根漢美術館的麥可·施密特。

Yeah, hey guys, thanks for taking my questions. Yeah, a question on STELLAR-303. Obviously, great positive announcement here earlier on hitting OS in the ITT analysis. And yeah, I think some of us are just curious how you think zanza may be positioned in the broader colorectal cancer landscape, perhaps relative to other new treatment options, including Fruquintinib which we hear is making some inroads in the market?

是的，嘿夥計們，謝謝你們回答我的問題。是的，關於 STELLAR-303 的一個問題。顯然，早些時候在 ITT 分析中就 OS 發布了非常積極的公告。是的，我想我們中的一些人只是好奇您認為 zanza 在更廣泛的結直腸癌領域中的定位如何，也許相對於其他新的治療選擇而言，包括我們聽說正在市場上取得一些進展的 Fruquintinib？

And then question number two, obviously, the trial hit the ITT analysis. So at this point, how important is succeeding on the NLM subset later on in terms of regulatory approvals or commercial marketing ability down the road? Thanks so much.

然後是第二個問題，顯然，試驗觸及了 ITT 分析。那麼就目前情況而言，就未來的監管部門批准或商業行銷能力而言，NLM 子集的成功有多重要？非常感謝。

Great. Thanks, Michael. Amy, please have at it.

偉大的。謝謝，麥可。艾米，請繼續。

Sure, I'll try and answer both of those. So just stepping back, I appreciate the recognition of the importance of an OS benefit in colorectal cancer, which is the fourth leading cause of cancer-related deaths in the US. And OS is unequivocal in that it is the gold standard in oncology drug development. Also noting that this is the only IO-TKI positive Phase III study. four have failed before us, not exclusive to Esai’s LEAP relativity, and I think T-Form is the other one.

當然，我會盡力回答這兩個問題。因此，退一步來說，我很欣賞對大腸直腸癌 OS 益處重要性的認識，大腸直腸癌是美國癌症相關死亡的第四大原因。毫無疑問，OS 是腫瘤藥物開發的黃金標準。還要注意的是，這是唯一一項 IO-TKI 呈陽性的 III 期研究。在我們之前，已有四個研究失敗，這並非 Esai 的 LEAP 相對論所獨有，我認為 T-Form 是另一個。

So we're also excited about the data, and we're excited about the fact that this did hit in the ITT patient population. It's really important to be able to continue to bring novel therapies to patients. So it would be the only other potential doublet available to patients if it gets approved, including Lonsurf.

因此，我們對這些數據感到很興奮，我們對這確實對 ITT 患者群體產生了影響感到很興奮。能夠繼續為患者帶來新的治療方法確實非常重要。因此，如果獲得批准，它將成為唯一可供患者使用的其他潛在雙聯藥物，包括 Lonsurf。

How we think about the NLM subgroup - it's a different prognostic subgroup. We know that their survival is longer. It's a dual primary endpoint. So we did hit on OSS and the ITT, so we have a positive study. We will continue to follow though, as per the statistical design for the NLM patient population, and I think it's important to show that there's benefit equally across all subgroups.

我們如何看待 NLM 亞群 — — 它是一個不同的預後亞群。我們知道他們的生存期更長。這是一個雙重主要終點。因此，我們確實對OSS和ITT進行了研究，因此我們進行了積極的研究。不過，我們將繼續按照 NLM 患者群體的統計設計進行跟踪，我認為重要的是表明所有亞群都有同等的益處。

So we're looking forward to waiting for that data, which we will know more about lateras we get closer when we have it, but we're really looking forward to discussing with the regulators, the topline data in ITT, as well as sharing the data to the broader community in a medical conference.

因此，我們期待著等待這些數據，當我們獲得這些數據時，我們會了解更多信息，但我們真正期待的是與監管機構討論 ITT 中的頂線數據，以及在醫學會議上與更廣泛的社區分享這些數據。

Asthika Goonewardene, Truist Securities.

Asthika Goonewardene，Truist 證券公司。

Hi guys, thanks for taking my questions. I want to layer on to Michael's previous question. It sounds like we're having similar thoughts about this too off in our investor discussions. Maybe if you can tell us, with STELLAR-303, the language in the press release was a little bit maybe on the conservative side. So could you maybe tell us if you have a view whether the data in the ITT population is clinically meaningful? I think that's been a debate point here in our discussions with investors.

大家好，感謝你們回答我的問題。我想繼續回答邁克爾先前提出的問題。聽起來我們在投資者討論中對此也有類似的想法。也許您可以告訴我們，關於 STELLAR-303，新聞稿中的語言可能有點偏保守。那麼，您能否告訴我們，您是否認為 ITT 族群中的數據具有臨床意義？我認為這是我們與投資者討論的爭論點。

And secondly, do you have plans to advance zanza in combinations in earlier lines in CRC? And could you just maybe tell us what looks most attractive to you? Thanks, guys.

其次，您是否計劃在 CRC 的早期系列中改進 zanza 的組合？您能否告訴我們什麼對您最有吸引力？謝謝大家。

Amy, please.

艾米，請。

Yeah, thanks for the question. So the language, Asthika, in the press release is purposely conservative. We are in a new and highly dynamic regulatory environment such that a conservative tone is warranted. Qualitative interpretation is by definition subjective, but let me please be very clear: OS is unequivocal as an endpoint and is the gold standard for approval. The combination of zanza and atezo demonstrated an improvement in overall survival against an active comparator and it was statistically significant. And we look forward to sharing the data with the broader community.

是的，謝謝你的提問。因此，Asthika，新聞稿中的語言是故意保守的。我們正處於一個全新且高度動態的監管環境中，因此採取保守的態度是合理的。定性解釋從定義上來說是主觀的，但請讓我明確一點：OS 作為終點是明確的，是批准的黃金標準。zanza 和 atezo 的組合相對於活性對照藥物而言顯示出總體生存率的提高，並且具有統計意義。我們期待與更廣泛的社群分享這些數據。

With regard to additional studies with zanzalintinib and moving into earlier lines of therapy, I did talk a little bit about an area that we are keenly interested in, which would evaluate monotherapy zanzalintinib in the adjuvant setting in patients who have really exhausted all available care to them, which is typically surgery and sometimes includes chemotherapy. And these patients have a high risk of recurrence.

關於對 zanzalintinib 的進一步研究以及進入更早的治療方法，我確實談到了我們非常感興趣的一個領域，即評估 zanzalintinib 單藥療法在輔助治療中對已經用盡所有可用治療方法（通常是手術，有時包括化療）的患者的效果。這些患者的復發風險很高。

And sometimes recurrence can come as soon as a year, and these patients have nothing available to them, but to sits and wait for their next CT scan to determine whether or not their disease has recurred. So if we could offer something there to delay disease recurrence, potentially prevent the recurrence of disease, we think that that would be a really meaningful impact to patients.

有時，最快一年後就會復發，而這些患者除了等待下一次 CT 掃描來確定疾病是否復發之外，別無他法。因此，如果我們可以提供一些方法來延緩疾病復發，甚至可能預防疾病復發，我們認為這將對患者產生真正有意義的影響。

Silvan Tuerkcan, Citizens.

Silvan Tuerkcan，公民。

Thank you. Thanks so much for taking my question, and congrats on the execution this quarter. I just wanted to see if you could comment, please, on the pricing dynamics with cabozantinib, especially with respect to the 340B volume and the reimbursement there in the near future and post- the Big Beautiful Bill? Thank you.

謝謝。非常感謝您回答我的問題，並祝賀本季度的執行情況。我只是想看看您是否可以評論一下卡博替尼的定價動態，特別是關於 340B 的數量以及近期和《美麗新藥法案》後的報銷情況？謝謝。

Yeah. Thanks, Silvan. Chris, you want to take that?

是的。謝謝，西爾萬。克里斯，你想接受這個嗎？

Yeah, Silvan, thanks for the question. Yeah, I mentioned that we saw a 4 percentage point increase in our volume shifts towards the 340B segment of our customers. And that payer segment is highly discounted segments. So it's having an impact on our gross-ton-net. And that's also from an overall industry perspective.

是的，Silvan，謝謝你的提問。是的，我提到過，我們看到向 340B 部分的客戶轉移量增加了 4 個百分點。而付款人部分是折扣力道很大的部分。所以這對我們的總噸位淨額產生了影響。這也是從整個產業的角度來看的。

There are a lot of companies that are seeing higher utilization in this payer segment. But from a cabo perspective, what we're seeing is our continued success at becoming the standard of care. We're also seeing the sites of care are expanding, and so, we have a greater number of 340B facilities utilizing cabo. So based on what we know today, we're projecting gross-to-net will probably coming closer to the 30% range versus what I had previously provided in the 29% to 30% range.

許多公司都發現這項付款人部分的使用率更高。但從卡波的角度來看，我們看到的是我們在成為護理標準方面不斷取得成功。我們也看到護理站點正在擴大，因此，我們有更多的 340B 設施利用 cabo。因此，根據我們今天所掌握的信息，我們預測毛利率與淨利率之比可能會接近 30% 的範圍，而我之前給出的預測是 29% 到 30% 的範圍。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Right. Thanks for taking that. I have a couple of interrelated questions. Maybe the first one on 304, the primary endpoint is PFS and ORR. Do you have to hit them both? Or is it one that it's a dual where one of them can over-sway the other? Because I imagine ORR might be earlier than PFS.

正確的。謝謝你接受。我有幾個相互關聯的問題。可能是 304 上的第一個，主要終點是 PFS 和 ORR。你必須打他們兩個嗎？或者說，它們是雙重的，其中一個可以影響另一個？因為我認為 ORR 可能比 PFS 更早。

And then maybe secondly, just on 303 against STIVARGA. In the past did like six months, 10 years ago and then nine months more recently, how would you expect that control to sort of perform given that Avastin does about 10.8 months. So how, historically, is a bit relevant? Thank you.

然後也許其次，僅針對 STIVARGA 的 303。過去是六個月，十年前是九個月，考慮到 Avastin 的治療時間為 10.8 個月，您認為這種控制的效果如何？那麼從歷史上看，這有什麼關係呢？謝謝。

Yeah. Thanks, Yaron. Amy, you want to take those?

是的。謝謝，亞倫。艾米，你想拿走那些嗎？

Yeah. Thanks for the question. To clarify for STELLAR-304, it is a dual primary endpoint, PFS and ORR. So hitting on either one of them would constitute a positive study. The endpoints are also assessed by blinded independent radiology committee, so these are not investigator-assessed endpoints.

是的。謝謝你的提問。需要澄清的是，STELLAR-304 是一個雙重主要終點，即 PFS 和 ORR。因此，對其中任何一個進行研究都將構成一項積極的研究。這些終點也由盲法獨立放射委員會進行評估，因此這些不是研究者評估的終點。

When it comes to the control arm and 303, I'm not going to really talk about the data. I'm looking forward to sharing it with you at a future time. And as I mentioned, we will be discussing it as well with regulators with an intention to file a new drug application.

當談到控制臂和 303 時，我不會真正談論數據。我期待著將來能與你們分享。正如我所提到的，我們也將與監管機構討論此事，以提交新的藥物申請。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

Hey, thanks so much. So Mike, I think when we had caught up at ASCO, you had described the head and neck go-no-go decision to be a relatively low bar to proceed. And your team was confident you could have a competitive profile despite some of the emerging single-arm data from bi-specifics. I think CABO/NIVO has shown historically a response rate over 50% in that setting.

嘿，非常感謝。所以 Mike，我想當我們在 ASCO 上見面時，你曾說過，頭部和頸部的可行與否的決定是一個相對較低的門檻。儘管出現了一些來自雙特異性的單臂數據，但您的團隊仍然相信您可以擁有競爭力。我認為 CABO/NIVO 在這種環境下的歷史響應率超過 50%。

Can we affirm that the zanza data looks similar or worse to cabo, and that's what drove your decision to not move that forward? And what were you expecting from a clinical profile there relative to what was shown from an event-rates perspective? Thank you.

我們能否確認 zanza 數據看起來與 cabo 類似或更差，這就是您決定不繼續前進的原因？相對於從事件發生率角度所顯示的情況，您對臨床概況有何期望？謝謝。

Yeah, Amy, you want to take that?

是的，艾米，你想接受這個嗎？

Yeah, sure. So I wasn't in the conversation, but I can tell you that it's a dynamic landscape. We're in the business of developing drugs and really are - hopefully, you can hear from the sense of urgency in my voice - unwavering in our mission to develop areas of high unmet need and generate results that really will have a meaningful impact to patients. Rigorous drug development requires continuous assessment. We had the study designed as a Phase II/III with a gate. We looked at the data and decided not to proceed to Phase III based on the competitive landscape, the regulatory environment and in the other areas that we would really like to focus zanza development in when you talk about Wave 2 of the franchise.

是的，當然。所以我沒有參與對話，但我可以告訴你，這是一個充滿活力的景象。我們從事藥物研發業務，而且確實——希望您能從我的聲音中聽出緊迫感——堅定不移地執行我們的使命，開發尚未滿足的大量需求領域，並產生真正對患者產生有意義影響的成果。嚴格的藥物開發需要持續的評估。我們將研究設計為具有門控的 II/III 期。我們查看了數據，並根據競爭格局、監管環境以及在談到特許經營的第二波時我們真正想集中精力進行 zanza 開發的其他領域，決定不進入第三階段。

Jason Gerberry, Bank of America Securities.

美國銀行證券公司的 Jason Gerberry。

Hey, guys, thanks for taking my questions. So just want another follow-up on STELLAR-303 and the extent that you could comment on the enrollment demographics and maybe if there are any variables that help lead to a different outcome than LEAP-017. I believe that you could have enrolled up to 40% of patients with non-liver met, so pretty much highly similar to LEAP-017, but potentially that could have gone a little bit higher. So I don't know if you're able to comment on directionally the enrollment skew with patients with non-liver met.

嘿，夥計們，謝謝你們回答我的問題。因此，我只想再次跟進 STELLAR-303 的情況，以及您對入學人口統計的評論程度，以及是否存在任何變數有助於得出與 LEAP-017 不同的結果。我相信您可以招募多達 40% 的非肝轉移患者，因此與 LEAP-017 非常相似，但可能會更高一些。所以我不知道您是否能夠對非肝病患者的入組偏差進行方向性評論。

And the opportunity with 303 in the adjuvant CRC setting, do you have a rough sense of what the US patient number is for that market? I imagine there's some proprietary market-segmentation data that maybe goes into sizing that. But any idea on if you can give us a sense on sizing there?

303 在輔助 CRC 治療領域的機會，您是否大致了解該市場的美國患者數量是多少？我想可能會有一些專有的市場區隔數據用於確定其規模。但是您能否告訴我們那裡的尺寸狀況呢？

Yeah, Jason, thanks for the questions. Amy, I take the first part, and then I'll opine on the second part.

是的，傑森，謝謝你的提問。艾米，我先討論第一部分，然後再對第二部分發表意見。

Sure. This was a global registrational study. We enrolled 900 patients. Whenever we're designing me is we need to make sure that the study is relevant to the various areas of the world, so that we can maintain equipoise in the enrollment and as well as ensure that there's consistency of benefit across all subpopulations. I'm not going to go into any details, but I'm looking forward to sharing those with you in the future.

當然。這是一項全球註冊研究。我們招募了 900 名患者。無論何時進行設計，我們都需要確保研究與世界各地相關，以便我們能夠在招生中保持平衡，並確保所有亞群的利益一致。我不會談論任何細節，但我期待將來與你們分享。

Yeah, and in terms of future studies in earlier lines of CRC, as Amy has spoken to about a potential adjuvant type study or post-adjuvant type study zanza monotherapy, we'll get into the details later as we're closer to launching that trial. We're really excited about it. We think it's a large opportunity built from a patient point-of-view and a potential revenue point-of-view, again, low to no competition and one that we think zanza is based upon its profile can do really well in. And so stay tuned, we'll talk about it more as we go forward.

是的，關於 CRC 早期階段的未來研究，正如 Amy 談到的關於潛在的輔助類型研究或輔助後類型研究 zanza 單一療法，我們將在稍後討論細節，因為我們即將啟動該試驗。我們對此感到非常興奮。我們認為，從患者的角度和潛在收入的角度來看，這是一個巨大的機會，而且競爭很低甚至沒有競爭，我們認為 zanza 基於其形象可以在這個領域做得很好。因此請繼續關注，我們將會進一步討論這個問題。

But this is the beginning of Wave 2. And we're certainly excited to be able to prioritize our investments as we go forward. I think that's the key thing. Look at the 305 decision as really simply prioritizing how we're going to invest in terms of high PTS, high-commercial potential opportunities as we go forward.

但這是第二波的開始。我們非常高興能夠在未來的發展中優先考慮我們的投資。我認為這是關鍵。將 305 決定視為實際上只是優先考慮我們未來如何在高 PTS、高商業潛力機會方面進行投資。

Leonid Timashev, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Leonid Timashev。

Hey, guys, it's Anish on for Leonid. Thanks for the updates this quarter and for taking our questions. Just with zanza not moving forward in head and neck, how are you thinking about balancing zanza's potential as a life cycle play to cabo in indications like RCC or NET versus in broader indications? As we think about leveraging an existing prescriber and patient base and work required to broaden that beyond what cabo touches, how are you framing your priorities there? Thanks so much.

嘿，夥計們，阿尼什 (Anish) 代替列昂尼德 (Leonid)。感謝您本季的更新以及回答我們的問題。由於 zanza 在頭部和頸部領域沒有取得進展，您如何考慮平衡 zanza 作為 cabo 在 RCC 或 NET 等適應症和更廣泛適應症中的生命週期潛力？當我們考慮利用現有的處方者和患者基礎，並進行必要的工作以擴大 Cabo 所涉及的範圍之外時，您如何制定優先事項？非常感謝。

Yeah, I guess the status quo in terms of Wave 1 and Wave 2 is still moving forward. We’re looking to maximize success with zanza by impacting more patients as possible and having the impact on their disease, the maximal impact we could have on their disease. So when you think about the overlap with cabo, we're looking at newer indications in terms of zanza combinations with belzutifan with the studies that Merck are doing.

是的，我猜第一波和第二波的現狀仍在向前發展。我們希望透過盡可能影響患者並對他們的疾病產生影響，最大限度地發揮 zanza 的成功率，即我們對他們的疾病所能產生的最大影響。因此，當您考慮與 cabo 的重疊時，我們正在根據默克公司正在進行的研究，研究 zanza 與 belzutifan 組合方面的新適應症。

Amy talked about 311 today, launching that study in NET with zanza monotherapy against everolimus head-to-head. So a win there would really define a superior product in terms of a head-to-head study. And then the second wave, in terms of reinforcing the success we've seen so far clinically in 303 and CRC by moving up in therapy, is certainly very important to adding new indications that we talked about as well, further getting beyond the cabo reach.

艾米今天談到了 311，在 NET 中啟動了 zanza 單藥療法與依維莫司進行正面交鋒的研究。因此，從正面對比研究的角度來看，如果能取得勝利，那麼產品就真正具有優越性。然後，第二波，就鞏固我們迄今為止在 303 和 CRC 臨床上看到的成功而言，透過提高治療方法，對於增加我們談到的新適應症，進一步超越 cabo 範圍，無疑非常重要。

So again, the whole focus here is to reinforce the expertise that we have, the strength that we have in the TKI franchise to go beyond cabo, to build a larger franchise in terms of scope, impact for patients and revenue. And that plan is only being reinforced today with the overall schemes that we're pushing forward.

因此，這裡的重點是加強我們的專業知識、我們在 TKI 特許經營方面的實力，以超越 cabo，在範圍、對患者的影響和收入方面建立更大的特許經營權。如今，我們正在推進的整體方案將進一步強化這項計畫。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Hey, thanks for taking our questions. So maybe one epidemiology question. So what percentage would you characterize as high-risk post-adjuvant in the CRC setting? And maybe one on 303 about duration. I guess, in RCC, most of the data therapy trials were one year in duration. I'm just thinking about if that's something that you're thinking about as well, and whether the 303 tolerability profile could also inform that treatment duration, too? Thank you.

嘿，感謝您回答我們的問題。所以也許有一個流行病學問題。那麼，您認為 CRC 輔助治療後高風險的比例是多少？也許 303 上還有一條關於持續時間的說明。我猜，在 RCC，大多數數據治療試驗持續一年。我只是想知道您是否也在考慮這個問題，303 耐受性概況是否也可以指導治療持續時間？謝謝。

So Amy, take the second question first, and then I'll follow up on the adjuvant.

那麼艾米，請先回答第二個問題，然後我會跟進佐劑的問題。

Yeah. So I appreciate the question with regard to duration, which defines how long patients are on therapy. I think we have to take that in the context of that colorectal is still the fourth leading cause of cancer-related deaths in the US. So duration plus population of patients, I think, brings a potential to make a difference in a lot of people's lives.

是的。因此，我很理解關於治療持續時間的問題，它決定了患者接受治療的時間長度。我認為我們必須考慮到大腸直腸癌仍然是美國第四大癌症死亡原因。因此，我認為，持續時間加上患者人數有可能改變許多人的生活。

And when we think about moving it earlier in lines of therapy and an adjuvant, the duration there would be obviously defined by probably a longer period of time in the patients that we're talking about who have higher risk of disease. You're looking at Stage II or III patients whose risk of recurrence is measured more in months - early months, not years.

當我們考慮提前用於治療和輔助治療時，對於患病風險較高的患者，治療持續時間顯然會更長。您正在觀察的是 II 期或 III 期患者，其復發風險更多地以月為單位進行衡量 - 早期的幾個月，而不是幾年。

Yeah. Let me take that. So again, Andy, we'll give you more details about the zanza post-adjuvant study as we get closer to launching. What I'll say is the following, is that we look at the commercial opportunity. We have a great team within commercial that does that analysis for us. We think the combined opportunities that is represented by post-adjuvant study as well as the meningioma study is probably around 3x higher than what the head and neck study was.

是的。讓我來接手吧。因此，安迪，隨著 zanza 輔助治療後研究的臨近，我們將向您提供更多詳細資訊。接下來我要說的是，我們來看看商業機會。我們在商業領域擁有一支優秀的團隊，可以為我們進行分析。我們認為，輔助治療後研究以及腦膜瘤研究所代表的綜合機會可能比頭頸部研究高出約 3 倍。

So again, from the standpoint of how we're prioritizing investments and allocating resources, both in terms of capital as well as human resources, we think it makes a lot of sense to move forward in these new indications as quickly as possible because the need is there. The competition is very low to none, and the commercial opportunity is very, very high.

因此，從我們如何優先考慮投資和分配資源（包括資本和人力資源）的角度來看，我們認為盡快推進這些新適應症是非常有意義的，因為有需求。競爭非常低甚至沒有，商業機會非常高。

Andrew Berens, Leerink Partners.

安德魯貝倫斯，Leerink Partners。

Okay, thanks. A couple more questions on the CRC program and STELLAR-303. The FDA has made demonstrating contribution of parts of a priority. Just wondering if you think that STELLAR-303 has met that bar. And then some concerns I've heard from investors are that the intent to treat OS benefit may have been driven by an improvement in the non-liver met patients that are part of the cohort and the impact on checkpoint inhibitor efficacy. I know the NMOS analysis is not read out yet, which is probably contributing to this concern.

好的，謝謝。關於 CRC 程序和 STELLAR-303 還有幾個問題。FDA 已對部分優先事項做出了示範性貢獻。只是想知道您是否認為 STELLAR-303 已達到該標準。然後，我從投資者那裡聽到的一些擔憂是，治療 OS 益處的意圖可能是由隊列中非肝轉移患者的改善以及對檢查點抑制劑療效的影響所驅動的。我知道 NMOS 分析尚未讀出，這可能加劇了這種擔憂。

But is there anything you can say to address this? How important is it that you demonstrate a definitive benefit in the patients that have liver mets? Thanks.

但是您能說些什麼來解決這個問題嗎？證明肝轉移患者確實受益有多重要？謝謝。

Amy, go ahead, please.

艾米，請說吧。

Yeah. Yes. Thanks for the question. So contribution of components is something that we have long recognized as an important factor for this study. And I will remind you of ASCO GI earlier this year, where we showed STELLAR-001 colorectal cancer cohorts, zanza versus zanza plus atezo and across all efficacy parameters, ORR, PFS, OS, DOR, the addition of atezo to zanza was there. So we have contribution of components coming from a separate study.

是的。是的。謝謝你的提問。因此，我們早就認識到成分的貢獻是本研究的重要因素。我要提醒大家今年早些時候的 ASCO GI，我們展示了 STELLAR-001 結直腸癌隊列、zanza 與 zanza 加 atezo 的比較，以及所有療效參數、ORR、PFS、OS、DOR，其中 atezo 添加到 zanza 中。因此，我們有來自單獨研究的組成部分的貢獻。

And in terms of the NLM and subgroups, I'm not going to get into any of the data. We have a positive OS readout in the intent-to-treat patient population. As you yourself pointed out, we continue to follow for OS and NLM. And we look forward to sharing all the data as soon as we can.

就 NLM 和子群而言，我不會涉及任何資料。我們在意向治療患者群體中獲得了積極的 OS 讀數。正如您自己指出的那樣，我們將繼續關注 OS 和 NLM。我們期待盡快分享所有數據。

Derek Archila, Wells Fargo.

德里克·阿奇拉，富國銀行。

Hey, thanks for taking the questions. Just one on NET in terms of how should we be thinking about the revenue trajectory post second quarter? And the next couple of quarters have launched more bolus-like before steadying off as you need to roll over these indolent patients become candidates for therapy. And then just a follow-up, just can you discuss the breadth of prescribing that you're seeing among the target positions so far? Thanks.

嘿，謝謝你回答這些問題。關於 NET，我們該如何看待第二季後的營收走勢？在接下來的幾個季度中，我們將推出更多類似推注的藥物，然後逐漸穩定下來，因為您需要將這些惰性患者轉變為治療的候選人。然後只是一個後續問題，您能否討論一下到目前為止您在目標職位中看到的規定廣度？謝謝。

Yeah. Thanks for the question. We're not going to give quarter-to-quarter guidance, obviously, we don't do that. So we're very excited about where we stand in the second quarter, which is again our first full quarter of launch. All the narratives that we've been talking about in terms of what that means, I think are pretty clear. I won't repeat those here.

是的。謝謝你的提問。我們不會提供季度指導，顯然我們不會這樣做。因此，我們對第二季的狀況感到非常興奮，這也是我們推出產品後的第一個完整季度。我認為，我們所討論的關於其含義的所有敘述都非常清楚。我不會在這裡重複這些。

PJ, you want to add some color commentary on the second part of that question?

PJ，你想對這個問題的第二部分添加一些有趣的評論嗎？

Yeah. As far as the prescriber base, I'd say we're pleased generally. We're seeing prescriptions broadly, as I mentioned, in terms of academic, in terms of community. We're seeing prescriptions from cabo naive prescribers as well as legacy cabo prescribers. So basically, we're seeing activation and/or sort of more prescriptions from prior prescribers. So we're pleased with those kinetics across the board.

是的。就處方者基礎而言，我想說我們總體上是滿意的。正如我所提到的，我們在學術方面、社區方面都看到了廣泛的處方。我們看到了來自卡波初級處方者和卡波傳統處方者的處方。所以基本上，我們看到了來自先前的處方者的啟動和/或更多的處方。因此，我們對整體動力學感到滿意。

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

Hi, Exelixis team. Thank you for taking my question. My first one is in regards to the positive pipeline release that you had for the OS benefit in STELLAR-303, does the dual endpoint give the opportunity to at least get approval for one of the patient populations if are there any nuances with either the NLM or the liver met population that makes it not as favorable when filing with the FDA? And then secondly, I wanted to squeeze in, if you can opine if the current reiterated guidance ranges include contributions from NET? Thanks.

嗨，Exelixis 團隊。感謝您回答我的問題。我的第一個問題是關於您在 STELLAR-303 中針對 OS 益處所發布的積極管道發布，如果 NLM 或肝臟轉移人群存在任何細微差別，導致在向 FDA 提交申請時不那麼有利，那麼雙終點是否至少為其中一個患者群體提供了獲得批准的機會？其次，我想插入一下，您是否可以判斷目前重申的指導範圍是否包括來自 NET 的貢獻？謝謝。

Go ahead, Amy.

繼續吧，艾米。

Yes. Thanks for the question. I'm not going to really speculate on what would suffice for approval. The dual primary endpoint is designed such that you can be positive on one.

是的。謝謝你的提問。我不會真正猜測什麼才足以獲得批准。雙重主要終點的設計使得您可以對其中一個結果呈陽性。

Chris, take the second one?

克里斯，拿第二個嗎？

Yeah. So thanks for the question. As Mike mentioned last quarter, we increased guidance when we increased guidance by about $100 million to the midpoint. Some of that was related to NET, a lot of that was related to the base business.

是的。感謝您的提問。正如麥克上個季度提到的那樣，當我們將指導金額提高約 1 億美元至中點時，我們提高了指導金額。其中一些與 NET 相關，很多與基礎業務相關。

Peter Lawson, Barclays.

巴克萊銀行的彼得·勞森。

Hey, Chris, just following up around the details around the guidance. Is there any way we should think about clinical trial revenues in the second half? Thank you.

嘿，克里斯，我只是想了解一下有關指導的細節。我們該如何考慮下半年的臨床試驗收入？謝謝。

Yeah, Peter, thanks for the question. I mean as we said probably a couple of years now, the clinical trial sales are choppy. We have some visibility occasionally, but we don't have a very good line of sight to when the clinical trial sales are coming through. So it's hard to say. So that's about it.

是的，彼得，謝謝你的提問。我的意思是，正如我們所說的，可能幾年前，臨床試驗的銷售一直不穩定。我們偶爾會有一些了解，但我們無法很好地了解臨床試驗銷售何時完成。所以很難說。就是這樣。

Stephen Willey, Stifel.

史蒂芬威利（Stephen Willey），Stifel。

Yeah, thanks for taking the questions, and congrats on the STELLAR-303 readout. Just I guess a quick clarification question on the 305 decision. So I think I remember you guys were blinded to the data, and that a DMC would be, I guess, evaluating some threshold level of efficacy metrics and then allowing you to proceed on a blinded basis to potentially upsize the study.

是的，感謝您回答這些問題，並祝賀 STELLAR-303 讀數。我只是想快速澄清一下有關 305 決定的問題。所以我想我記得你們對數據是盲目的，而我猜 DMC 會評估一些功效指標的閾值水平，然後允許你們在盲法基礎上進行研究，以潛在地擴大研究規模。

So can you just kind of talk through the cadence of the decision in terms of assessing the competitive landscape and then seeing the data. Were those two things done in lockstep, or did the former proceed the latter? Thanks.

那麼，您能否從評估競爭格局和查看數據的角度來談談決策的節奏。這兩件事是同步進行的，還是前者先於後者？謝謝。

Go ahead, Amy, please.

請繼續，艾米。

Yeah. Thanks. So I'm not going to go into a whole lot of detail here. The trial was designed with the gate. We reviewed the unblinded data. We may have a path forward in head and neck, and we'll determine if additional studies are warranted. But for now, we're prioritizing other indications and allocating resources accordingly. Head and neck is a unique population, and we'll share the data at a future time.

是的。謝謝。所以我不會在這裡詳細闡述。試驗是採用門設計的。我們審查了未盲數據。我們可能在頭部和頸部方面取得了進展，我們將確定是否有必要進行進一步的研究。但目前，我們正在優先考慮其他適應症並相應地分配資源。頭部和頸部是一個獨特的群體，我們將在未來分享數據。

Ashwani Verma, UBS.

瑞銀的 Ashwani Verma。

Oh yeah, thanks for taking my question. So for STELLAR-303, I'm trying to understand if this ITT data can come at a medical conference this year, or do we wait until next year? Just another way to ask the same thing, can you still present the ITT portion of the study without reaching the final analysis on NNM? Thanks.

哦，是的，感謝您回答我的問題。因此，對於 STELLAR-303，我想了解這個 ITT 數據是否可以在今年的醫學會議上公佈，還是要等到明年？換一種方式問同樣的問題，如果不對 NNM 進行最終分析，您還能展示研究的 ITT 部分嗎？謝謝。

Yeah. Thanks for the question. We're not discussing the venue for the data presentation, but we'll provide the data once the abstract titles are made publicly available, but we’ve presented the dual primary end point before where we've hit on one and still waited for the other.

是的。謝謝你的提問。我們沒有討論數據展示的場地，但我們會在摘要標題公開後提供數據，但我們之前已經展示了雙重主要終點，我們已經找到了一個，但仍在等待另一個。

Thank you. At this time, I'm showing no further questions. So I will now turn the call over to today's host, Susan Hubbard. Ms. Hubbard?

謝謝。目前，我沒有其他問題。現在我將把電話轉給今天的主持人蘇珊·哈伯德。哈伯德女士？

Yeah. Thank you, Towanda, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call.

是的。謝謝你，托萬達，也謝謝大家今天加入我們。如果您有任何其他問題，而我們在今天的通話中未能解答，歡迎您再次來電諮詢。

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。