Exelixis Inc (EXEL) 2026 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Exelixis second quarter 2026 financial results conference call. My name is Kathleen, and I will 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 2026 年第二季財務業績電話會議。我是 Kathleen，今天將擔任本次會議的接線員。提醒各位，本次電話會議將錄音以供日後重播。

I would now like to turn the call over to your host for today, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed.

現在我想把電話交給今天的主持人——策略與投資人關係資深副總裁 Andrew Peters 先生。請開始。

Thank you, Kathleen, and thank you all for joining us for the Exelixis' second quarter 2026 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; 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 second quarter 2026 ended June 30, 2026.

謝謝你，Kathleen，也感謝各位參加 Exelixis 2026 年第二季財務業績電話會議。今天與我一同出席的有：總裁暨執行長 Mike Morrissey；財務長 Chris Senner；研發執行副總裁 Dana Aftab；以及商務執行副總裁 P.J. Haley。我們將回顧截至 2026 年 6 月 30 日止之 2026 年第二季的進展。

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，我們將提及若干非依一般公認會計原則（GAAP）計算的財務衡量指標。請參閱今日發布並已張貼於我們網站的新聞稿，其中說明我們使用此類非 GAAP 指標的原因，並提供由 GAAP 結果推導至這些指標的對照表。

During the course of this presentation, we will be making forward-looking statements regarding future events in 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.

在本次簡報過程中，我們將就公司未來事件及未來表現作出前瞻性陳述。其中包括關於研發探索、產品開發、法規監管、商業、財務與策略事項的可能進展、潛在成長機會，以及政府藥品定價政策與倡議的相關陳述。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 Securities and Exchange Commission, which under the heading Risk Factors, identify important factors that could cause actual results to differ 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, our dependence on collaboration partners and the level of costs associated with the discovery, product development, business development and commercialization activities.

我們請各位參閱我們不時向美國證券交易委員會（SEC）提交的文件；其中在「風險因素」項下列示可能導致實際結果與公司今日口頭及書面陳述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、監管審查與核准流程、臨床試驗執行、遵循適用監管要求、我們對合作夥伴的依賴，以及與探索、產品開發、業務開發與商業化活動相關成本水準等風險與不確定性。

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

接下來，我把電話交給 Mike。

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. Exelixis continues to execute across the key elements of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond. We are in the early innings of our next phase of growth as we deliver on our strategy to evolve from a single compound company to one with a pipeline of potential oncology franchise opportunities.

好的。謝謝你，Andrew，也感謝各位今天加入我們的電話會議。Exelixis 持續在業務的關鍵要素上穩健執行，使公司得以實現 2026 年及更長遠的策略目標。隨著我們推進從單一化合物公司，轉型為擁有多個潛在腫瘤特許經營（franchise）機會之產品線的策略，我們正處於下一階段成長的早期階段。

Zanzalintinib is poised to transform Exelixis as our next franchise molecule, potentially first with a third-line plus CRC filing that’s currently under review, followed by accelerating progress on the next six pivotal trials that we’ve highlighted recently.

Zanzalintinib 有望成為我們下一個特許經營分子，進而改變 Exelixis；其潛在的第一步可能是目前正在審查中的第三線及以上 CRC 申請，之後我們也將加速推進近期重點提及的另外六項關鍵性（pivotal）試驗。

Importantly, a second wave of trials is lining up nicely to initiate potentially as early as 2027. Our confidence in cabo's long-term revenue growth trajectory remains unchanged. The updated financial guidance reflects modestly slower growth in 2026 and due to a more gradual ramp for the NET indication, which reflects the unique characteristics of the NET patient population and histology.

同樣重要的是，第二波試驗的規劃進展順利，最早可能於 2027 年啟動。我們對 cabo 長期營收成長軌跡的信心維持不變。更新後的財務指引反映 2026 年成長略為放緩，原因在於 NET 適應症的放量（ramp）較為循序漸進，這也反映 NET 病患族群與組織學（histology）的獨特特性。

We remain confident in the long-term potential of the cabo NET indication and view the NET franchise as an important growth driver for cabo, zanza and other molecules in our pipeline. We continue to see meaningful opportunities to expand our impact for patients, strengthen our commercial position and create value for shareholders.

我們仍對 cabo 的 NET 適應症長期潛力充滿信心，並將 NET 特許經營視為 cabo、zanza 及我們產品線中其他分子的重要成長驅動力。我們持續看到可觀的機會，得以擴大對病患的影響、強化我們的商業地位，並為股東創造價值。

Our strategy to build a multi-franchise oncology business contains five key elements, including: first, execution. Zanza is leading the pack as our next potential franchise opportunity and our highest R&D priority. The EXEL team continues to execute on key objectives across the program, including the STELLAR-303 regulatory review, pivotal trial data readouts, expediting clinical trial enrollments and new study initiations.

我們打造多特許經營腫瘤業務的策略包含五個關鍵要素，其中第一是：執行。Zanza 作為我們下一個潛在特許經營機會領先群雄，也是我們研發的最高優先事項。EXEL 團隊持續推進該計畫的關鍵目標，包括 STELLAR-303 的監管審查、關鍵性試驗數據讀出（readout）、加速臨床試驗收案，以及啟動新的研究。

The second is expansion. We are building the foundation for the next wave of growth opportunities for zanza. Beyond our current pivotal trials, we are actively evaluating new development opportunities that could further expand the scope, reach and long-term value of zanza in GU, GI and other indications. Our goal is to build a durable franchise with stacking capabilities that could drive growth for years to come.

第二是：擴張。我們正在為 zanza 的下一波成長機會奠定基礎。除目前的關鍵性試驗外，我們也正積極評估新的開發機會，以進一步擴大 zanza 在泌尿生殖（GU）、腸胃道（GI）及其他適應症的範疇、觸及面與長期價值。我們的目標是建立具持久性的特許經營，並具備可堆疊（stacking）能力，以推動未來多年成長。

The key element is commercial performance. We continue to see substantial growth from the cabozantinib franchise. Cabo remains the leading TKI for RCC the market leader for the oral second-line plus net segment and a key player in the treatment of patients with liver and thyroid cancers.

第三個關鍵要素是：商業表現。我們持續看到 cabozantinib 特許經營帶來顯著成長。Cabo 仍是 RCC 領域的領先 TKI、口服第二線及以上 NET 細分市場的領導者，並在肝癌與甲狀腺癌患者治療中扮演關鍵角色。

Second quarter 2026 US cabo franchise net product revenues grew approximately 10% year-over-year to $573 million. Continuing its role as a worldwide leading TKI, global cabo franchise net product revenues generated by Exelixis and its partners grew approximately 13% year-over-year to $806 million in the second quarter 2026.

2026 年第二季，美國 cabo 特許經營淨產品營收年增約 10%，達 5.73 億美元。作為全球領先的 TKI 之一，由 Exelixis 及其合作夥伴所產生的全球 cabo 特許經營淨產品營收於 2026 年第二季年增約 13%，達 8.06 億美元。

Fourth is preparation. We continue to prioritize our commercial readiness for the potential launch of zanza and third line plus CRC, pending a positive regulatory review later this year. We believe the CRC opportunity represents an important first step towards establishing zanza as our second oncology franchise and a significant driver of future growth. We see this element of our strategy is especially timely as we pursue new GU and GI indications specifically in tandem, early and late-stage opportunities in CRC with STELLAR-303 and STELLAR-316.

第四是：準備。我們持續優先確保商業端就緒，以因應 zanza 在第三線及以上 CRC 的潛在上市（launch）；此仍取決於今年稍晚監管審查的正面結果。我們相信 CRC 機會是將 zanza 建立為我們第二個腫瘤特許經營的重要第一步，並將成為未來成長的重要驅動力。在我們同步推進新的 GU 與 GI 適應症之際，特別是透過 STELLAR-303 與 STELLAR-316 於 CRC 的早期與後期開發機會，我們認為此策略要素尤為及時。

Fifth and finally, discipline. We remain committed to rigorous expense management and capital allocation. This can be seen by trimming expense guidance, while we invest in our mission-critical R&D priorities and keeping our projected free cash flow essentially unchanged. We believe this balanced approach remains an important differentiator and positions us to create long-term value while maintaining strategic flexibility.

第五也是最後一點：紀律。我們仍致力於嚴謹的費用管理與資本配置。這可從我們下修費用指引，同時投資於任務關鍵的研發優先事項，並使預估自由現金流基本維持不變看出。我們相信這種平衡作法仍是重要的差異化因素，使我們在維持策略彈性的同時，得以創造長期價值。

Taken together, these five strategic elements, working in tandem, underscore the strength of our strategy and the progress we are making across the business. We believe we are well positioned to advance zanza towards becoming a major oncology franchise, expand our development portfolio, drive continued growth to the cabozantinib franchise and deploy capital in a disciplined manner to maximize shareholder value. So, with that, please see our press release issued an hour ago for our quarterly financial results and a comprehensive summary of key corporate milestones achieved during the period.

綜合而言，這五項策略要素相互配合，凸顯我們策略的強度以及我們在整體業務上取得的進展。我們相信，我們已具備良好條件推進 zanza 成為主要腫瘤特許經營、擴大開發組合、推動 cabozantinib 特許經營持續成長，並以紀律方式部署資本以最大化股東價值。因此，請參閱我們於一小時前發布的新聞稿，其中包含本季財務結果以及本期間達成之重要公司里程碑的完整摘要。

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

接下來，我把電話交給 Chris。

Thanks, Mike. For the second quarter of 2026, the company reported total revenues of approximately $629 million, which included cabozantinib franchise net product revenues of $573 million. CABOMETYX net product revenues were $571 million and included approximately $2.7 million in clinic trial sales. As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future.

謝謝你，Mike。2026 年第二季，公司報告總營收約 6.29 億美元，其中包含 cabozantinib 特許經營淨產品營收 5.73 億美元。CABOMETYX 淨產品營收為 5.71 億美元，其中包含約 270 萬美元的臨床試驗銷售。再次提醒各位，臨床試驗銷售在各季度之間歷來波動較大，我們預期未來仍將如此。

Gross to net for the cabozantinib franchise in the second quarter 2026 was 29.5%, which is lower than the gross to net we experienced in the first quarter 2026. This decrease in gross to net deductions in the second quarter 2026 is primarily due to lower co-pay assistance for commercial patients, which is partially offset by a modest increase in 340B utilization when compared to the first quarter of 2026.

2026 年第二季 cabozantinib 產品線的毛額轉淨額（gross to net）為 29.5%，低於我們在 2026 年第一季所經歷的毛額轉淨額。2026 年第二季毛額轉淨額扣減項目下降，主要是因為商業保險患者的自付額補助（co-pay assistance）降低；與 2026 年第一季相比，340B 使用率小幅上升，部分抵銷了上述影響。

Additionally, we're updating our estimate for full year 2026 gross to net deductions, and we are now projecting that it will be between 30% and 31%. Our CABOMETYX trade inventory was flat at 2.1 weeks on hand at the end of the second quarter 2026 when compared to the first quarter 2026. Total revenues in the second quarter 2026 also includes approximately $53 million in royalties earned from our partners Ipsen and Takeda on their sales of cabozantinib.

此外，我們正在更新對 2026 全年毛額轉淨額扣減的估計，目前預測將介於 30% 至 31% 之間。截至 2026 年第二季末，我們的 CABOMETYX 通路庫存與 2026 年第一季相比持平，手上庫存為 2.1 週。2026 年第二季總營收亦包含約 5,300 萬美元的權利金，係由合作夥伴 Ipsen 與 Takeda 就其 cabozantinib 銷售所產生並支付給我們。

Our total operating expenses for the second quarter 2026 were approximately $380 million compared to $359 million in the first quarter 2026. The sequential increase in these operating expenses was primarily driven by higher clinical trial costs, marketing expenses and stock-based compensation.

2026 年第二季我們的總營業費用約為 3.80 億美元，較 2026 年第一季的 3.59 億美元增加。營業費用的季增主要由臨床試驗成本上升、行銷費用增加以及以股票為基礎的薪酬增加所帶動。

Provision for income taxes for the second quarter 2026 was approximately $50.6 million compared to a provision for income taxes of approximately $57.2 million for the first quarter 2026. The company reported GAAP net income of approximately $212 million or $0.85 per share basic and $0.82 per share diluted for the second quarter 2026. The company also reported GAAP net income of approximately $237 million or $0.95 per share basic and $0.91 per share or fully diluted. Non-GAAP net income excludes the impact of approximately $25 million of stock-based compensation, net of the related income tax effect. Cash and marketable securities for the quarter ended June 30, 2026, for approximately $1.4 billion.

2026 年第二季所得稅費用準備約為 5,060 萬美元，較 2026 年第一季約 5,720 萬美元的所得稅費用準備為低。公司 2026 年第二季依 GAAP 認列淨利約 2.12 億美元，基本每股盈餘 0.85 美元、稀釋後每股盈餘 0.82 美元。公司亦報告 GAAP 淨利約 2.37 億美元，基本每股盈餘 0.95 美元、稀釋後每股盈餘 0.91 美元（完全稀釋）。非 GAAP 淨利排除約 2,500 萬美元的以股票為基礎的薪酬影響（已扣除相關所得稅影響後之淨額）。截至 2026 年 6 月 30 日止季度的現金及有價證券約為 14 億美元。

During the second quarter of 2026, we repurchased approximately $312 million of the company’s outstanding common stock, resulting in the retirement of approximately 6.5 million shares of the company’s outstanding common stock at an average price per share of $47.85. During the second quarter 2026, we did the October 2025 stock repurchase program. As of the end of the second quarter 2026, we had approximately $598 million remaining under the $750 million stock repurchase plan authorized by the company's Board in May of 2026.

在 2026 年第二季期間，我們回購了約 3.12 億美元的公司流通普通股，並以每股平均 47.85 美元的價格註銷約 650 萬股公司流通普通股。2026 年第二季，我們執行了 2025 年 10 月的股票回購計畫。截至 2026 年第二季末，在公司董事會於 2026 年 5 月核准的 7.50 億美元股票回購計畫下，我們尚餘約 5.98 億美元可供回購。

And finally, we're updating our full year 2026 financial guidance. We are lowering and narrowing our total revenues and net product revenue guidance, which lowers the midpoint by $50 million when compared to our previous guidance. This updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the NET indication, than the original projection.

最後，我們更新 2026 全年財務指引。我們下調並收窄總營收與產品淨營收指引區間，使其中位數較先前指引下調 5,000 萬美元。此更新後的財務指引反映 2026 年成長略為放緩，原因是 NET 適應症的放量（ramp）較原先預估更為循序漸進。

Additionally, we are reducing R&D expense guidance, lowering the midpoint of our R&D expense guidance range by $50 million when compared to the previous guidance. Details of our full year guidance can be found on slide 14 of our earnings presentation.

此外，我們也下調研發（R&D）費用指引，與先前指引相比，將研發費用指引區間的中位數下調 5,000 萬美元。全年指引的詳細內容可見於我們財報簡報第 14 頁。

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

接下來，我把電話會議交給 PJ。

Thank you, Chris. CABOMETYX net product revenue grew 10% year-over-year for Q2 2026 relative to Q2 2025. Revenue growth for the first half of 2026 was modestly slower than we had anticipated due to a more gradual ramp in the growth of NET in the second-line plus setting due to patient kinetics. Importantly, we are pleased that cabo has achieved second-line plus oral class new patient market share greater than 45%, and we believe this is a leading indicator for future growth of the NET business. The RCC business continues to grow as we have a strong promotional focus on our first line 9ER data, where we maintain a high market share as the number one TKI plus IO combination in addition to being the number one prescribed TKI in renal cell carcinoma.

謝謝你，Chris。CABOMETYX 2026 年第二季的產品淨營收相較 2025 年第二季年增 10%。由於患者動態（patient kinetics）因素，NET 在二線及以上治療情境的成長放量較為循序漸進，導致 2026 年上半年營收成長略低於我們原先預期。重要的是，我們很高興 cabo 在二線及以上口服同類（oral class）新患者的市占率已超過 45%，我們相信這是 NET 業務未來成長的領先指標。RCC 業務持續成長，因為我們在第一線 9ER 數據上有強而有力的推廣重點；我們不僅維持作為腎細胞癌中排名第一的 TKI+IO 聯合療法的高市占率，同時也是腎細胞癌中處方量最高的 TKI。

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, Q2 2025 to Q2 2026, CABOMETYX grew 2 share points from 45% to 47%. Additionally, CABOMETYX TRx volume grew 12% in Q2 2026 compared to Q2 2025, outpacing the growth rate of the market basket, which was 6% for the same period.

在口服 TKI 市場組合（market basket）中，包含 cabo、lenvatinib、axitinib、sunitinib 與 pazopanib 的處方數據，顯示 cabo 相對於競品的強勢。從 TRx 對比來看，2025 年第二季到 2026 年第二季，CABOMETYX 的市占率提升 2 個百分點，從 45% 增至 47%。此外，CABOMETYX 的 TRx 量在 2026 年第二季較 2025 年第二季成長 12%，優於同期間市場組合 6% 的成長率。

CABOMETYX was approved for NET about a year ago, and we have many learnings regarding this unique tumor type. NET is heterogeneous and generally more indolent than many more aggressive solid tumor malignancies.

CABOMETYX 約在一年前獲得 NET 適應症核准，我們也針對這種獨特的腫瘤類型累積了許多學習。NET 具有異質性，且一般而言比許多更具侵襲性的實體腫瘤惡性疾病更為惰性（indolent）。

As we have been in the market speaking with physicians and conducting advisory Boards, we have learned that this may lead to differences in management of these patients. Sometimes NET patients are scanned less frequently than a standard 3-month interval and often a patient's disease may be relatively slow growth. Furthermore, the initiation of subsequent therapy could be less urgent for some patients, resulting in attenuation of a current treatment or sometimes a treatment break. Hence, the patient kinetics of NET in the second line plus setting can be more gradual than other solid tumors.

在市場上與醫師交流並進行顧問委員會（advisory Boards）時，我們了解到這可能導致對這些患者的管理方式有所不同。有時 NET 患者的影像掃描頻率低於標準的每 3 個月一次，且患者疾病進展往往相對緩慢。此外，對部分患者而言，啟動後續治療的急迫性可能較低，因而出現目前治療強度降低，或有時暫停治療。因此，在二線及以上治療情境中，NET 的患者動態可能比其他實體腫瘤更為循序漸進。

That said, we continue to be pleased with the market dynamics as the CABOMETYX second-line plus oral new patient grew substantially in the second quarter 2026 to over 45%, extending the brand's leadership position in the space. We have begun to see the benefit of more patients on therapy as refills are driving more demand and given the increased new patient market share, we expect refills to continue to increase going forward.

儘管如此，我們仍對市場動態感到滿意，因為 CABOMETYX 在二線及以上口服新患者的市占率於 2026 年第二季大幅成長至超過 45%，進一步鞏固品牌在該領域的領導地位。隨著更多患者持續用藥、續配（refills）帶動需求增加，我們已開始看到更多在治療患者所帶來的效益；鑑於新患者市占率提升，我們預期未來續配將持續增加。

Market research indicates that there is opportunity to continue to grow market share, particularly in the community setting. Our expanded GI sales team was in the field providing greater reach into the community in Q2, and we believe this contributed to an increase in our second-line plus NET market share.

市場研究顯示，市占率仍有持續成長的機會，尤其是在社區醫療（community）場域。我們擴編的 GI 銷售團隊在第二季於第一線提供更深入社區的覆蓋，我們相信這促成了我們二線及以上 NET 市占率的提升。

We also acquired and implement granular utilization data it gives us greater resolution on the NET business at the prescriber level for certain segments of the market. These data are giving us the ability to optimize our promotional efforts through refined targeting. To highlight the potential for cabo growth in NET, and we remain confident that as patients seek treatment after progression CABOMETYX will be the leading choice which will translate into a robust long-term opportunity.

我們也取得並導入更細緻的使用量（utilization）數據，使我們能在處方醫師層級、針對特定市場區隔，以更高解析度掌握 NET 業務。這些數據讓我們能透過更精準的目標鎖定來最佳化推廣工作。為了凸顯 cabo 在 NET 的成長潛力，我們仍有信心：隨著患者在疾病進展後尋求治療，CABOMETYX 將成為領先選擇，並轉化為強勁的長期機會。

Our new representatives joined us with significant oncology sales experience, particularly in colorectal cancer and GI oncology. The expanded sales team will gain valuable experience selling cabo before we turn our focus to the potential launch of zanzalintinib in colorectal cancer. As we're thinking about building on and expanding our GI franchise, we're thrilled with the results of STELLAR-303 and a PDUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in 1 of the “big 4” tumors.

我們的新任代表加入團隊時已具備豐富的腫瘤銷售經驗，特別是在結直腸癌與胃腸道（GI）腫瘤領域。在我們將重心轉向zanzalintinib於結直腸癌的潛在上市之前，擴編後的銷售團隊將先透過推廣cabo累積寶貴的銷售經驗。在我們思考如何鞏固並擴大GI產品線之際，我們對STELLAR-303的結果以及今年稍晚設定的PDUFA日期感到非常振奮。在取得監管核准的前提下，我們相信這些數據將為Exelixis在「四大」腫瘤之一帶來極具吸引力的商業機會。

Third line plus CRC setting consists of approximately 23,000 patients in the US and represents an overall opportunity of $1.5 billion in terms of contemporary pricing. Our market research and advisory boards demonstrate positive feedback and excitement for the STELLAR-303 data. Physicians reiterate the significant unmet need for patients in the third-line CRC setting and are excited for the potential to have a regimen that includes an immune checkpoint inhibitor available for the broader population of CRC patients.

美國結直腸癌第三線及以上治療情境約有23,000名患者，按當前定價計算，整體機會約為15億美元。我們的市場調研與諮詢委員會顯示，對STELLAR-303數據的回饋正面且令人振奮。醫師一再強調第三線結直腸癌患者仍存在顯著未被滿足的醫療需求，並對於有望提供包含免疫檢查點抑制劑之治療方案、可供更廣泛結直腸癌患者使用的可能性感到期待。

CABOMETYX business remains strong, with growth being driven by both RCC and NET as our team's sole focus is maximizing the impact of our promotional efforts across all customers and tactics. Cabo remains well positioned as the number 1 TKI and TKI plus IO combination in RCC as well as the number 1 oral therapy in second-line plus NET.

CABOMETYX業務維持強勁，成長由RCC與NET共同驅動；我們團隊的唯一重點是最大化我們在所有客戶與各項策略上的推廣成效。在RCC領域，cabo仍穩居第1的TKI，以及TKI加IO的組合；同時在NET第二線及以上治療中，亦為第1的口服治療。

Looking forward to zanza, our internal team is in full launch preparation and the excitement around these efforts is palpable. We look forward to the opportunity to launch the next Exelixis franchise later in the year to be able to help appropriate patients with colorectal cancer.

展望zanza，我們內部團隊正全力進行上市準備，對這些工作的熱情溢於言表。我們期待在今年稍晚推出下一個Exelixis產品線的機會，以協助適合的結直腸癌患者。

Beyond STELLAR-303, we are enthusiastic about the significant development plan for zanza, which could position the zanza franchise to far exceed cabo in terms of the number of patients that could be impacted across tumor types and settings.

除了STELLAR-303之外，我們也對zanza的重要開發計畫感到振奮；該計畫有望使zanza產品線在可影響的患者人數上，跨越不同腫瘤類型與治療情境，遠超cabo。

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

接下來，我把電話會議交給Dana。

Thanks, PJ. My update today will be focused mostly on the seven ongoing or imminent pivotal trials for zanza as well as some updates on additional exploratory studies and plans to continue driving the breadth of development to zanza, all of which is aligned with our strategy in R&D, which prioritizes developing zanza as a multidimensional solid tumor oncology franchise molecule.

謝謝，PJ。我今天的更新將主要聚焦於zanza目前進行中或即將啟動的七項關鍵性（pivotal）試驗，同時也會提供其他探索性研究的最新進展，以及我們持續推動zanza開發廣度的計畫；這些都與我們研發策略一致，即優先將zanza打造為具多面向的實體腫瘤腫瘤學產品線分子。

Starting with our NDA for zanza plus atezo in colorectal cancer, which is based on the results from the STELLAR-303 trial. This continues to be our top priority as we work toward the PDUFA date in early December. Our team continues to focus on the ongoing review and is fully engaged in launch preparations.

先從我們針對結直腸癌、zanza合併atezo的NDA申請談起，該申請以STELLAR-303試驗結果為基礎。在我們朝向12月上旬的PDUFA日期推進之際，這仍是我們的首要優先事項。我們的團隊持續專注於審查流程並全力投入上市準備。

Alongside those activities, we've also been steadily moving forward on our strategy to realize zanza's franchise potential by continuing to drive the breadth of development of zanza in key tumor landscapes and indications. In the early colorectal space, our team has been highly focused on launching the STELLAR-316 trial, which will investigate zanza with and without subcutaneous pembro in patients with resected Stage II or III CRC who, following definitive therapy have tested positive for molecular residual disease or MRD and have no radiographic evidence of disease.

在推進上述工作的同時，我們也穩步推動策略，以實現zanza作為產品線的潛力，持續在關鍵腫瘤領域與適應症中擴大zanza的開發廣度。在結直腸癌早期治療領域，我們團隊高度聚焦於啟動STELLAR-316試驗；該試驗將在已切除的II期或III期結直腸癌患者中，研究zanza合併或不合併皮下注射pembro的療效；這些患者在完成根治性治療後，分子殘存病灶（MRD）檢測呈陽性，且影像學未見疾病證據。

The unmet need is high for these patients, and we've gotten a lot of positive feedback on the study from KOLs in the GI oncology community. Activation of the first site in this trial is imminent, with many more lined up behind it, and we anticipate patient screening to begin this month. With Natera as our collaborator, we've been able to select sites based on actual test metrics, prioritizing those with the highest numbers of MRD-positive patients. So we're confident this approach will translate to a steep enrollment curve, especially since there are no other ongoing Phase III trials competing for these patients.

這些患者的未被滿足需求很高，我們也從GI腫瘤領域的KOL獲得許多對該研究的正面回饋。本試驗第一個中心即將啟動，後續還有更多中心排隊準備，我們預期本月開始進行患者篩選。在合作夥伴Natera的協助下，我們得以依據實際檢測指標選定研究中心，優先選擇MRD陽性患者數量最多的中心。因此我們有信心此作法將帶來陡峭的入組曲線，尤其是目前沒有其他正在進行的III期試驗與我們競爭這些患者。

In the neuroendocrine tumor indication, STELLAR-311 is our global Phase III trial evaluating zanza compared to everolimus as an initial oral therapy in patients with pancreatic or extra pancreatic neuroendocrine tumors. That study was initiated last year, and we continue to see robust enrollment that is months ahead of projections, reflecting both investigator and patient enthusiasm for the study.

在神經內分泌腫瘤適應症方面，STELLAR-311是我們的全球III期試驗，評估zanza相較於everolimus，作為胰臟或非胰臟來源神經內分泌腫瘤患者的初始口服治療。該研究於去年啟動，我們持續看到強勁的入組速度，較預測提前數個月，反映研究者與患者對該研究的高度熱忱。

Moving on to genitourinary tumors and kidney cancer specifically. STELLAR-304 is our first pivotal trial for zanza in kidney cancer, evaluating the combination of zanza plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma.

接著談泌尿生殖系腫瘤，特別是腎癌。STELLAR-304是zanza在腎癌領域的首個關鍵性試驗，評估zanza合併nivolumab相較於sunitinib，用於局部晚期或轉移性非透明細胞腎細胞癌患者。

I’d like to emphasize that the non-clear cell RCC space is underserved with no positive readouts from a Phase III study, specifically focused on these patients despite them representing approximately 20% of all RCC cases. A handful of Phase II studies, the majority of which are single-arm, nonrandomized trials have shown activity with a range of treatments in this setting with wide variations in response rates and durations of PFS for sunitinib and other agents that are currently patients.

我想強調，非透明細胞RCC領域長期資源不足；儘管此類患者約占所有RCC病例的20%，但迄今尚無專門針對這些患者、且在III期研究中取得正向讀出結果的試驗。少數II期研究（多數為單臂、非隨機試驗）顯示在此情境下多種治療具有活性；然而，對於sunitinib及其他目前用於患者的藥物，其反應率與PFS持續時間的結果差異很大。

Such variations are to be expected when comparing data across trials, especially when those trials are small and geographically restricted. Given the fact that STELLAR-304 is the first large randomized controlled Phase III trial for these patients and is also enrolling globally.

在跨試驗比較數據時，出現此類差異是可以預期的，尤其當試驗規模小且地理範圍受限時更是如此。鑑於STELLAR-304是首個針對這些患者的大型隨機對照III期試驗，且同時在全球入組。

We expect that, if positive, the trial could establish the first ever Level 1 evidence for benefit and a new standard of care for these patients. We completed enrollment in STELLAR-304 last year. And given current event rates, we continue to expect top line results from the study in the second half of 2026. If positive, those results could lead to our second NDA filing for zanza.

我們預期若結果為正，該試驗可望建立首個一級證據（Level 1 evidence）以證明臨床獲益，並為這些患者帶來新的照護標準。我們已於去年完成STELLAR-304的入組。依據目前事件發生率，我們仍預期在2026年下半年取得該研究的主要結果（top line results）。若結果為正，這些結果可能促成我們針對zanza的第二項NDA申請。

Pivoting now to clear cell, our progress continues with regard to the two pivotal Phase III studies that Merck is running to evaluate zanzalintinib in combination with belzutifan. The LITESPARK-033 trial is comparing zanza plus belz versus cabo in the frontline setting for patients who received adjuvant treatment with anti-PD-1 or anti-PD-L1 therapy. And LITESPARK-034 is comparing zanza plus belz versus belz plus placebo in the second-line plus setting after both anti-PD-1 or L1 and VEGFR TKI therapies.

接著轉到透明細胞領域，我們在Merck主導的兩項關鍵性III期研究方面持續取得進展，該等研究評估zanzalintinib合併belzutifan。LITESPARK-033試驗在一線治療情境中，比較zanza合併belz與cabo；納入對象為曾接受抗PD-1或抗PD-L1輔助治療的患者。LITESPARK-034則在二線及以上治療情境中，比較zanza合併belz與belz合併安慰劑；納入對象為先前已接受抗PD-1或L1以及VEGFR TKI治療的患者。

We’re excited to see these Phase III studies in clear cell RCC moving forward, and we believe there are other important opportunities to explore in this space, pairing zanza with other modalities and orthogonal mechanisms in first-line RCC, especially immunotherapies given the demonstrated clinical differentiation we’ve observed with zanza and its potential to be the TKI of choice for combinations with immunotherapies as well as other mechanisms of action. Our discussions with potential collaborators have been advancing well, and we plan to give further updates on these activities as we get closer to launching the trials.

我們很高興看到這些透明細胞RCC的III期研究持續推進；同時我們也認為在此領域仍有其他重要機會可探索，例如在一線RCC中將zanza與其他治療模式及正交機制（orthogonal mechanisms）進行搭配，尤其是免疫治療；因為我們已觀察到zanza具備臨床差異化，且其有潛力成為與免疫治療及其他作用機制聯合使用時的首選TKI。我們與潛在合作夥伴的討論進展順利，並計畫在更接近啟動試驗時，進一步更新這些活動的進展。

Moving on now to other indications in the GU space. We’re excited to advance an expansion cohort in the ongoing STELLAR-002 study to evaluate zanza in patients with metastatic bladder cancer who have progressed on the combination of enfortumab vedotin or EV plus pembro. The rationale for this cohort is based on a significant body of data generated with cabo showing encouraging activity in bladder cancer.

接下來談談泌尿生殖（GU）領域的其他適應症。我們很高興在進行中的 STELLAR-002 研究中推進一個擴增隊列，以評估 zanza 用於轉移性膀胱癌患者，這些患者在 enfortumab vedotin（EV）合併 pembro 的治療後出現疾病進展。此隊列的科學依據來自於 cabo 所累積的大量數據，顯示其在膀胱癌中具有令人鼓舞的活性。

Bladder was not prioritized for pivotal development with cabo due to the rapidly changing landscape at that time. What’s changed since then is the approval of the combination of EV plus pembro in multiple settings, including in the front line for patients with metastatic disease. This resulted in an important new standard of care for these patients, but very quickly a new unmet need emerged with essentially no established standard of care for patients after they progress on the combination.

由於當時治療格局快速變化，膀胱癌並未被列為 cabo 進行關鍵性（pivotal）開發的優先項目。自那時以來的變化是 EV 合併 pembro 已在多個治療情境獲得核准，包括用於轉移性疾病患者的一線治療。這為這些患者帶來了一個重要的新照護標準，但很快也出現了新的未被滿足需求：患者在該合併療法進展後，幾乎沒有既定的照護標準。

We’re enrolling a cohort in STELLAR-002 evaluating zanza as a single agent in patients who progressed on EV plus pembro, and we’re already seeing encouraging signs of clinical activity. It’s early days. But if the data continue to develop in this way, we plan to move quickly toward launching a pivotal study in this indication.

我們正在 STELLAR-002 中招募一個隊列，評估 zanza 作為單藥用於 EV 合併 pembro 治療後進展的患者，而我們已經看到一些令人鼓舞的臨床活性跡象。目前仍屬早期。但如果數據持續以這種方式發展，我們計畫迅速推進，在此適應症上啟動一項關鍵性研究。

Another expansion cohort, zanza in the STELLAR-002 study is in combination with docetaxel in patients with metastatic castration-resistant prostate cancer, or CRPC, who have measurable disease. The rationale for this cohort is based on data with cabo where a small Phase II study showed favorable outcomes when cabo was combined with docetaxel in patients with metastatic CRPC.

另一個擴增隊列是在 STELLAR-002 研究中評估 zanza 與 docetaxel 聯合，用於具有可測量病灶的轉移性去勢抗性前列腺癌（CRPC）患者。此隊列的科學依據來自 cabo 的數據：一項小型第二期研究顯示，cabo 與 docetaxel 聯合用於轉移性 CRPC 患者時有良好結果。

We're particularly excited about this cohort because if zanza in combination with docetaxel is shown to be safe and active, that could open up a number of opportunities across a range of solid tumors where docetaxel, other chemotherapies or ADCs carrying cytotoxic payloads remain the standard of care, such as in second-line non-small cell lung cancer. Sites for this expansion cohort in STELLAR-002 are now activated and open for enrollment.

我們對此隊列特別感到興奮，因為如果 zanza 與 docetaxel 的聯合被證實安全且具活性，將可在多種實體腫瘤中開啟多項機會；在這些腫瘤中，docetaxel、其他化療或攜帶細胞毒性載荷的 ADC 仍是照護標準，例如二線非小細胞肺癌。STELLAR-002 中此擴增隊列的研究中心現已啟動並開放招募。

Moving on now to STELLAR-201. This is our Phase II trial evaluating zanza in patients with recurrent meningioma who are no longer responsive to or eligible for local therapies. The primary endpoint of this trial is objective response rate with secondary efficacy endpoints, including duration of response, progression-free survival and overall survival. The trial will enroll up to 100 patients and our enrollment in this trial so far is exceeding our initial projections which we believe reflects the high level of interest and enthusiasm for the trial among neuro-oncologists.

接下來談 STELLAR-201。這是我們的第二期試驗，評估 zanza 用於復發性腦膜瘤患者，這些患者已不再對局部治療有反應或不符合局部治療資格。本試驗的主要終點為客觀反應率（ORR），次要療效終點包括反應持續時間、無惡化存活期（PFS）與總存活期（OS）。本試驗將招募最多 100 名患者，目前的入組進度超出我們最初的預期；我們認為這反映了神經腫瘤科醫師對該試驗的高度興趣與熱忱。

One factor driving excitement for this study is the fact that there are no accrued systemic therapies for meningioma that’s refractory to local therapies, so this indication represents a very high unmet need in neuro-oncology. Pending favorable results and given the absence of any approved systemic therapies in this setting, STELLAR-201 trial could be an important opportunity for zanza to become the first systemic therapy that could improve outcomes for these patients.

推動此研究受到關注的一個因素是：對於對局部治療無效的腦膜瘤，目前沒有已確立的全身性治療，因此此適應症在神經腫瘤領域代表極高的未被滿足需求。若結果正面，且鑑於此治療情境下缺乏任何已核准的全身性治療，STELLAR-201 試驗可能為 zanza 提供一個重要機會，使其成為首個可改善這些患者預後的全身性治療。

Lastly, we've been making steady progress toward an initiation of STELLAR-202. Our planned Phase II trial in squamous non-small cell lung cancer that will explore the addition of zanza in the maintenance phase after induction with pembro plus chemotherapy. The rationale for this trial is partly based on data from the CONTACT-01 trial, for the subgroup of non-small cell lung cancer patients with squamous histology appear to derive substantial benefit from the combination of cabo plus atezo compared to chemo.

最後，我們在推進 STELLAR-202 的啟動方面持續穩步進展。這是我們規劃中的第二期試驗，針對鱗狀非小細胞肺癌，將探索在以 pembro 合併化療誘導治療後的維持期加入 zanza。本試驗的科學依據部分來自 CONTACT-01 試驗數據：在非小細胞肺癌的鱗狀組織學亞組中，相較於化療，cabo 合併 atezo 似乎可帶來顯著獲益。

This is an important opportunity given the relatively short PFS in the maintenance setting and the lack of any new approvals in frontline squamous non-small cell lung cancer since KEYNOTE-407 established the current standard of care with pembro plus chemo. We expect to initiate STELLAR-202 in the second half of this year.

這是一個重要機會，因為維持治療情境下的 PFS 相對較短，而且自 KEYNOTE-407 確立 pembro 合併化療為目前照護標準以來，鱗狀非小細胞肺癌的一線治療尚無新的核准。我們預期將在今年下半年啟動 STELLAR-202。

Now shifting to our early clinical pipeline, our four molecules currently in clinical development, namely XL-309, XB-010, XB-628 and XB-371 continue to progress and we are also continuing to move new small molecule NAVC programs towards IND filings and development candidate nominations, and I look forward to sharing more details as these programs advance.

接著轉到我們的早期臨床研發管線，目前有四個分子正在臨床開發中，分別為 XL-309、XB-010、XB-628 與 XB-371，並且我們也持續推進新的小分子 NAVC 計畫，朝向 IND 申報與開發候選藥物提名邁進；隨著這些計畫推進，我也期待能分享更多細節。

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

那麼，我把電話交回給 Mike。

All right. Thanks, Dana. To close today's call, I'll start by thanking the entire Exelixis team for their great efforts during the first half of the year. 2026 continues to be a potentially transformational year for the company, and everyone at Exelixis is working together as one team with a single focus to improve outcomes for cancer patients and build value for all our shareholders. Advancing zanza as our second potential franchise opportunity remains our top priority while we use the revenues from cabo's growing business to invest in the pipeline while returning value to shareholders through our share repurchase program.

好的。謝謝你，Dana。在結束今天的電話會議前，我先感謝整個 Exelixis 團隊在今年上半年所付出的努力。2026 年仍可能是公司具有轉型意義的一年，Exelixis 的每一位同仁都以同一個團隊、同一個目標共同努力：改善癌症患者的治療結果，並為所有股東創造價值。推進 zanza 作為我們第二個潛在的產品平台機會仍是首要任務；同時，我們也將利用 cabo 業務成長帶來的營收投資研發管線，並透過股票回購計畫回饋股東。

I want to thank everyone at Exelixis for their individual and collective efforts, incredible focus as we work day in and day out on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

我要感謝 Exelixis 的每一位同仁在個人與團隊層面的付出，以及我們日復一日專注於使命的驚人投入：幫助癌症患者更強健地康復並活得更久。我們期待未來向各位更新我們的進展。感謝各位持續支持並關注 Exelixis，現在我們很高興開放提問。

(Operator Instructions)

（接線員指示）

Paul Choi, Goldman Sachs.

Paul Choi，高盛。

I want to ask on STELLAR-304 and timing. Do you think this is something that might be able to make a major medical meeting this year? And just any sort of updated precision on data timing that you could offer would be great.

我想詢問 STELLAR-304 以及時間點。你們認為今年是否有機會在重要醫學會議上發表？另外，如果能提供任何關於數據時間點更精確的更新資訊就太好了。

Dana, go ahead, please.

Dana，請你回答。

Sure. Thanks for the question, Paul. As I said in my prior remarks, we are expecting to achieve the planned number of events in the second half of this year. Beyond that, it wouldn’t really be appropriate for me to speculate on when exactly that’s going to happen or even when the data will be available at a medical meeting. What I can say is that we will message on that at the appropriate time.

好的。謝謝你的問題，Paul。如同我先前的說明，我們預期將在今年下半年達到計畫中的事件數。除此之外，我不太適合推測確切會在何時發生，甚至也不適合推測何時會在醫學會議上取得可用數據。我能說的是，我們會在適當的時間對外溝通。

Akash Tewari, Jefferies.

Akash Tewari，Jefferies。

This is Anastasia on for Akash. I wanted to ask about your first-line post-adjuvant study. Specifically, I think you guys have made a comment about maybe like a 15K patient population. I’m wondering if that changes at all based on the LITESPARK-022 study, the one that had improved DFS. Do you anticipate patients will start switching to an already existing pembro plus HIF-2 alpha? If you do, does that reduce your patient population? How are you viewing that data?

我是 Anastasia，代 Akash 提問。我想問你們的一線、術後輔助治療後（post-adjuvant）研究。具體來說，我記得你們曾提到可能約有 1.5 萬名患者族群。我想知道，基於 LITESPARK-022 研究（那項顯示 DFS 改善的研究），這個估算是否會有任何改變。你們是否預期患者會開始轉向既有的 pembro 合併 HIF-2 alpha？如果會，是否會縮小你們的患者族群？你們如何看待那份數據？

This is P.J. I think obviously very early days for the LITESPARK-022 combination just getting approved with belzutifan in the adjuvant setting. I think what we see in the first line setting in terms of patients overall coming off of previously treated adjuvant therapies in that kind of the 20% to 25% range of first line patients. I wouldn’t want to speculate with regards to how much utilization the combination will be used in the adjuvant setting, but I will say historically that setting is one that’s very sensitive to toxicity.

我是P.J.。我想很明顯，LITESPARK-022 的組合療法在輔助治療（adjuvant）情境中與 belzutifan 一起剛獲核准，仍然是非常早期的階段。我認為我們在一線治療情境中看到的是，整體而言，約有 20% 到 25% 的一線患者是從先前已接受過的輔助治療中轉出來的。我不想推測該組合療法在輔助治療情境中的使用率會有多高，但我會說，歷史上那個情境對毒性非常敏感。

This is I think a reason that agents with positive studies such as sunitinib really didn’t get uptake in that in the past, and I think with the overall survival bar that pembro monotherapy has set there, it’s a very high bar to beat. I think physicians will think very carefully as to whether or not they want to add toxicity in terms of another agent in this setting.

我認為這也是為什麼過去像 sunitinib 這類即使研究結果為正向的藥物，在那個情境中也沒有真正被廣泛採用的原因；而且我認為 pembrolizumab（pembro）單藥在那裡所建立的整體存活（OS）門檻非常高，很難超越。我認為醫師會非常審慎地評估，是否要在這個情境中加入另一個藥物所帶來的額外毒性。

Andy Hsieh, William Blair.

Andy Hsieh，William Blair。

I’m just curious about your take on the ongoing STELLAR-311 study against the backdrop of the guidance lowering, whether there’s a chance that it’s cannibalizing cabo sales, resulting in a more gradual ramp.

我只是好奇，在指引下修的背景之下，你對正在進行的 STELLAR-311 研究有何看法；是否有可能它正在分流（cannibalize）cabo 的銷售，導致爬坡更為緩慢？

Yes. P.J., please?

是的。P.J.，請？

As Dana said, we’re really excited, first and foremost about the STELLAR-311 study. I’ve had the opportunity to speak to a lot of KOLs obviously in the NET space. I’ll just say, they’re very excited about that study. As Dana says, it’s progressing well.

如 Dana 所說，我們首先、最重要的是，對 STELLAR-311 研究感到非常興奮。我也有機會和許多在 NET 領域的關鍵意見領袖（KOL）交流。我只能說，他們對這項研究非常期待。如 Dana 所說，研究進展順利。

I think, to your point, anytime you do have a study that is recruiting, it does draw potential patients from the commercial patient pool, so to speak. It can be a bit exacerbated in a smaller tumor type, for example. We think that could be having a small impact. But I’d say, certainly what I mentioned in terms of patient kinetics, in terms of just patients taking a bit more time to go from therapy in subsequent settings is really the driving factor, as it is a more indolent tumor type. And fortunately, these patients, many of them may have the luxury of a little more time before going on to that therapy.

我認為，如你所指出的，只要有研究在招募，確實就會從商業端的患者池中吸引一部分潛在患者。例如在較小的腫瘤類型中，這種情況可能會更明顯。我們認為這可能造成一些小幅影響。但我會說，我先前提到的患者動態（patient kinetics）——也就是患者在後線治療情境中從一種治療轉換到下一種治療所需時間變長——才是真正的主要驅動因素，因為這是一種較為惰性的腫瘤類型。而且幸運的是，這些患者中有許多人在開始該治療之前，可能有餘裕多一些時間。

That said, I think it’s really important, just to reiterate that I remain really excited about the opportunity in NET. We’re not really changing the outlook at all. As you mentioned, the ramp is a little more gradual, but we’re excited that we achieved a new patient market share over 45% this quarter. I’m sure you’ll recall that we always talked about the TAM in this setting as being about $1 billion for the oral therapy market in the second-line plus setting.

話雖如此，我認為仍然非常重要的是再次強調：我對 NET 的機會依然非常興奮。我們並沒有改變整體展望。如你所提到，爬坡確實較為漸進，但我們很高興本季新患者市占率達到 45% 以上，創下新高。我相信你也記得，我們一直談到在二線及以上情境中，口服治療市場的總可服務市場（TAM）約為 10 億美元。

We’re excited about that market share, and eventually those patients we believe when they do have a therapy selection, it will be cabo, in most of those cases. We’re excited about that going forward.

我們對這個市占率感到振奮；而且我們相信，最終當這些患者需要做治療選擇時，多數情況下會選擇 cabo。我們對未來發展感到期待。

Sean Laaman, Morgan Stanley.

Sean Laaman，Morgan Stanley。

Just with the CRC PDUFA date coming up later this year, what label language would be the most commercially meaningful? What label limitations, if any, around liver mets, prior therapy or subgroup interpretation do you think could be real that may constrain uptake?

隨著今年稍晚 CRC 的 PDUFA 日期即將到來，什麼樣的標籤文字（label language）在商業上最具意義？你認為在肝轉移、既往治療或亞組解讀方面，是否可能出現任何標籤限制，進而抑制採用？

Yes. Thanks, Sean. Dana, want to take that one?

是的。謝謝你，Sean。Dana，你要回答這題嗎？

Yeah, sure. As I mentioned, Sean, earlier, this is an ongoing review. Our team is highly focused and extremely excited, in fact, about what this can mean for the company, especially given the fact that, if approved, this would be the first immunotherapy-containing regimen for the vast majority of patients with this disease. And also it would be the first launch of our next franchise molecule. It means a lot for patients and for the company. There’s a lot of excitement around this. Beyond that, we really can’t comment on an ongoing review and especially on a label that is really up to discussions with the agency.

好的，當然。如我先前提到的，Sean，這是一項正在進行中的審查。我們的團隊高度專注，事實上也非常興奮，因為這對公司可能意味著重大影響；尤其考量到若獲核准，這將會是此疾病絕大多數患者的第一個含免疫治療的治療方案。同時，這也將是我們下一個特許經營（franchise）分子首次上市。這對患者與公司都意義重大。大家對此充滿期待。除此之外，對於正在進行中的審查，我們確實無法評論，尤其是標籤內容主要取決於與主管機關的討論。

Silvan Tuerkcan, Citizens Bank.

Silvan Tuerkcan，Citizens Bank。

This is Josh on for Silvan. At the beginning of, maybe it was 2025, Exelixis shared their vision for $5 billion in revenue for zanza by 2033. Now, I guess a year and a half from that point, can you highlight the progress made towards that goal and if, how the makeup of that projection has evolved since then?

我是代 Silvan 提問的 Josh。在一開始——可能是 2025 年——Exelixis 分享了他們對 zanza 到 2033 年達到 50 億美元營收的願景。現在，從那個時間點算起大約一年半後，你能否說明朝該目標所取得的進展，以及（如果有的話）該預測的組成自那時以來如何演變？

That number was given, I would say late 2024, around our aspirational view on what success could look like relative to our second franchise molecule. The fact that we have launched or are about to launch, one of the seven pivotal trials with the next wave on the way, I think speaks to the depth and breadth of the opportunity.

那個數字我會說是在 2024 年底提出的，代表我們對第二個特許經營分子成功樣貌的願景性（aspirational）看法。我們已經推出或即將推出七項關鍵性試驗（pivotal trials）中的其中一項，且下一波也在路上，我認為這反映了機會的深度與廣度。

Going forward, super excited about what’s already in the oven, if you will, and then the next wave, as you heard Dana talk about today, potentially involving other GU and GI indications we think is potentially super valuable for patients as well as driving value for shareholders. Obviously, we have a lot of work to do. We’re in the execution business, we’re committed to making this second franchise as valuable for patients and for shareholders as possible.

展望未來，我們對已經在「烤箱裡」的項目（如果你願意這麼說）以及下一波都感到非常興奮；正如你今天聽到 Dana 提到的，下一波可能涵蓋其他泌尿生殖（GU）與腸胃道（GI）適應症，我們認為這對患者可能非常有價值，也能為股東創造價值。顯然，我們還有很多工作要做。我們是做執行的，我們承諾要讓這第二個特許經營對患者與股東都盡可能有價值。

Kalpit Patel, Wolfe Research.

Kalpit Patel，Wolfe Research。

Just one on the Handa tentative approval. We’ve been fielding questions on that, and my question is, if they do get the conversion, or they get the full approval, does that, in any sense, accelerate the timing of the generic developers, the agreements that you have in place before the 2031 timelines?

我想問一題關於 Handa 的暫定核准（tentative approval）。我們一直收到相關問題；我的問題是，如果他們完成轉正（conversion）或取得正式核准（full approval），這是否在任何意義上會加速學名藥開發商的時程——也就是你們在 2031 年時程之前已簽訂的那些協議？

Yes. Andrew?

是的。Andrew？

Hey, Kalpit. Thanks for the question. Can’t really get into the specifics of the agreements that we’ve had with the other true Handa generic filers. But I would note that the sort of scenario that you’re describing isn’t particularly common in these sorts of agreements, and so I wouldn’t think it’s something to expect.

嗨，Kalpit。謝謝你的問題。我們無法深入說明與其他真正的 Handa 學名藥申請方（generic filers）所簽訂協議的細節。但我會指出，你所描述的那種情境在這類協議中並不常見，因此我不會認為那是需要預期的事情。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

I have maybe it’s kind of a dual part question. The first one on meningioma, STELLAR-201. It’s really encouraging to see how fast it enrolled. We’ve seen in these areas that a single-arm phase II can lead to approval. How fast do you think you can generate data? Kind of what’s the standard of care historically shown?

我可能有一個算是雙重部分的問題。第一個是關於腦膜瘤、STELLAR-201。看到它招募速度這麼快，真的很令人鼓舞。我們在這些領域看到，單臂第二期試驗是可能導向核准的。你們認為可以多快產出數據？歷史上標準治療大概是怎麼樣？

And then secondly, maybe just on Handa, can you maybe walk us through some of the precedence on whether a new sort of salt can actually get NCCN guideline placement without generating clinical data?

第二個，可能是關於Handa，你能否帶我們了解一下先例：一種新的鹽類形式是否能在不產生臨床數據的情況下，仍然獲得NCCN指引收錄？

Yes. Dana, why don't you start and then we'll do a quick turn over.

是的。Dana，你先開始，然後我們再快速補充。

Regarding STELLAR-201, this is a single-arm phase II study designed to enroll 100 patients with meningioma who have progressed on or are no longer candidates for local therapies. As I mentioned, it’s a very high unmet need. There’s no standard of care for these patients. The excitement on the trial is really being driven in part by the emerging data from a small study with cabozantinib.

關於STELLAR-201，這是一項單臂第二期研究，設計招募100位腦膜瘤患者，這些患者在局部治療後仍進展，或已不再適合接受局部治療。如我提到的，這是一個非常高的未被滿足醫療需求。對這些患者而言並沒有標準治療。這項試驗的熱度部分來自於一項使用cabozantinib的小型研究所出現的新興數據。

Our intention is to bring the appropriate data to regulatory authorities at the appropriate time. But in the meantime, we’re also in the process of designing a confirmatory Phase III trial. As you’re kind of hinting at, this could be a very fast process. The details of that really need to evolve over time. We really can’t comment on that at this time.

我們的意圖是在適當的時間，向監管機關提交適當的數據。但同時，我們也正在設計一項確認性第三期試驗。如你所暗示的，這可能會是一個非常快速的流程。相關細節確實需要隨時間逐步演進。目前我們真的無法就此發表評論。

Andrew?

Andrew？

On the 505(b)(2) dynamics, a couple of things to mention here is, there are pretty big differences between the kind of standard Handa pathway and the 505(b)(2). Things like labeling, therapeutic equivalents, interchangeability, those are all very different for 505(b)(2) products. You correctly pointed out the new 505(b)(2) is a different salt with very different properties around PK and some other things as we outline in our citizens petition.

關於505(b)(2)的動態，有幾點要提：所謂標準的Handa途徑與505(b)(2)之間存在相當大的差異。例如標示（labeling）、治療等效性（therapeutic equivalents）、可互換性（interchangeability），這些在505(b)(2)產品上都非常不同。你也正確指出，這個新的505(b)(2)是不同的鹽類形式，在藥物動力學（PK）以及其他一些特性上有很大差異，我們也在公民請願（citizens petition）中加以說明。

As NCCN considers all of those dynamics and the real lack of clinical data, it kind of contrasts with other 505(b)(2) examples like ABRAXANE that have been successful in their adoption, but that has largely been based on large Phase III trials, large randomized Phase III trials, established efficacy.

當NCCN考量所有這些動態，以及臨床數據的實質缺乏時，這就與其他505(b)(2)成功被採納的案例形成對比，例如ABRAXANE；但那主要是建立在大型第三期試驗、且是大型隨機第三期試驗與已確立的療效之上。

I guess kind of the key thing from Exelixis perspective is we’re focused on two things, patient safety and prioritizing our intellectual property rights, and we’re going to continue to focus on those two things. I think as you think about guideline recommendations, that patient safety dynamic is really important.

我想從Exelixis的角度來看，關鍵是我們專注於兩件事：病人安全，以及優先維護我們的智慧財產權；我們會持續聚焦在這兩點。我認為在思考指引建議時，病人安全這個面向非常重要。

Michael Schmidt, Guggenheim Securities.

Guggenheim Securities 的 Michael Schmidt。

This is Michelle on for Michael. Thanks for taking my question. I just wanted to ask about STELLAR-304. It seems like enrollment ran for about nine to 10 months longer than the original protocol suggested. I was just wondering if you could speak a little to what drove that enrollment delay, and if you think that this extra time and follow-up means that the OS will be more mature at top line than you had originally expected.

我是代替Michael的Michelle。謝謝讓我提問。我想問STELLAR-304。看起來招募期比原始方案所暗示的時間多了大約9到10個月。我想請你談談是什麼因素造成招募延遲；以及你是否認為這段額外時間與追蹤，會讓主要結果公布時的OS（總生存期）成熟度比你們原先預期更高。

This is Dana. You’re commenting on trial dynamics, right? Where the numbers that you see in trials and progress posters company slides, clinicaltrials.gov listings are all based on projections. At the end of the day, enrollment happens as it happens, and we don’t have a perfect crystal ball to understand how these dynamics are really going to play out. We put our best foot forward, but there’s always some shift in these timelines, not just in enrollment timelines, but also in how the event rates come in.

我是Dana。你是在評論試驗的動態，對吧？你在試驗進度海報、公司簡報投影片、clinicaltrials.gov 列表上看到的數字，都是基於預測。最終招募就是依實際情況發生，我們並沒有完美的水晶球能理解這些動態究竟會如何發展。我們會盡最大努力，但這些時程總會有些變動，不僅是招募時程，也包括事件發生率（event rates）的進展。

As I mentioned in my prepared remarks, and actually, I think we mentioned for the first time last quarter at the earnings call that we’re expecting the trial to read out in the second half of the year. It’s still that now. We’re still planning for the second half of this year. Again, that’s our best estimate based on our event rates that are coming in currently.

如我在事先準備的發言中提到的，而且其實我想我們在上季財報電話會議上首次提到，我們預期該試驗會在今年下半年讀出結果。目前仍是如此。我們仍規劃在今年下半年。再次強調，這是基於目前進來的事件發生率所做的最佳估計。

Leonid Timashev, RBC.

RBC 的 Leonid Timashev。

Josh on for Leo. Thanks for taking my question. I was wondering how you might be thinking about zanza playing alongside novel agents in NETs like ADCs or some radiopharma programs that are out there.

我是代替Leo的Josh。謝謝讓我提問。我想了解你們如何看待zanza在NET（神經內分泌腫瘤）領域，與像是ADC或一些放射性藥物（radiopharma）計畫等新型藥物並行的定位。

Thanks. P.J., do you want to take that one?

謝謝。P.J.，你要回答這題嗎？

Yeah. I think as far as zanza and NET, the study is designed, and as Dana mentioned, and I kind of reiterated earlier, there’s a lot of excitement around this study, is designed to really position zanza to be potentially the first oral agent in neuroendocrine tumors.

好的。我認為就zanza與NET而言，這項研究的設計——如Dana提到、我先前也再次強調——之所以令人非常振奮，是因為它的設計確實是要把zanza定位為神經內分泌腫瘤中可能的第一個口服藥物。

Other modalities are there. Obviously, you have the SSAs, you have the radioligand therapies, and then kind of the orals. I’d say overall, as you think about the space, those are the three high-level modalities. Given the fact that this is the first Phase III randomized study to have the potential to read out positive relative to an approved oral agent, success in this study would position zanza, I think, very well in the neuroendocrine tumor marketplace.

其他治療模式也存在。很明顯，你有SSA（生長抑素類似物）、有放射性配體治療（radioligand therapies），然後還有口服藥物這一類。整體來說，若你思考這個領域，這三者是三種高層級的治療模式。鑑於這是第一個第三期隨機研究，且有機會相對於一個已核准的口服藥物讀出正向結果，若本研究成功，我認為將使zanza在神經內分泌腫瘤市場中的定位非常有利。

(Operator Instructions)

（接線員指示）

Jason Gerberry, Bank of America.

美國銀行（Bank of America）的 Jason Gerberry。

This is Chi on for Jason. Question is on NET. Given your observation on cabo brand in the NET indication, do you expect to see similar patient inflow kinetic dynamic for zanza in NET? Or will you expect a different trajectory for zanza if you can secure head-to-head data over everolimus in STELLAR-311? Just quickly, could you provide how much NET contribute to cabo sales this quarter?

我是代替Jason的Chi。問題是關於NET。基於你們對cabo品牌在NET適應症上的觀察，你們是否預期zanza在NET也會看到類似的病人流入速度與動態？或者，如果你們能在STELLAR-311中取得相對everolimus的頭對頭數據，你們是否預期zanza會有不同的成長軌跡？另外快速問一下，這一季NET對cabo銷售的貢獻有多少？

Yes. Thanks for the question, Chi. Again, I think when you think about zanza and NET, some of the things I’ve already spoken to here that position it really potentially well, obviously given a positive study, regulatory approval projecting here into the future, the fact that it is head-to-head, as you point out, with everolimus.

是的。謝謝你的問題，Chi。再次強調，當你思考zanza與NET時，我前面已談到一些可能讓它具備良好定位的因素；當然這裡是假設研究結果為正、並在未來取得監管核准的前提下；以及如你所指出的，它是與everolimus進行頭對頭比較。

A few things. Patient eligibility in the study, it’ll be positioned really as potentially a first or second-line agent. I think when you think about that, that will change the potential for the kinetics of the patient flow in that setting. We would expect it to potentially be different. Obviously very hard to project given so many variables before we see the data out in the future. But I think suffice to say, the KOLs are very excited about the study. When our top physicians are excited about it, that always gives us excitement. Really looking forward to the readout of that study.

幾點說明。研究中的病患納入條件方面，它的定位很可能會是第一線或第二線治療藥物。我認為當你這樣思考時，這將改變在該治療情境下病患流入的動態（kinetics）的潛力。我們預期它可能會有所不同。當然，在我們未來看到數據之前，因為變數太多，很難做出預測。但我想可以說的是，關鍵意見領袖（KOL）對這項研究非常興奮。當我們最頂尖的醫師對此感到興奮時，也總是讓我們感到振奮。非常期待該研究的結果讀出。

Etzer Darout, Barclays.

Etzer Darout，Barclays。

This is Luke on for Etzer. Thanks for taking our question. You’ve previously talked about potentially partnering zanza in the same way that you did cabo. Are you still looking to pursue that, or are you going to try and keep zanza internal globally?

我是代替 Etzer 的 Luke。感謝讓我們提問。你們先前談到可能會以與 cabo 類似的方式為 zanza 尋求合作夥伴。你們仍打算推進這件事嗎？還是會嘗試在全球範圍內將 zanza 留在內部自行推進？

Yes. It's Mike. Thanks for the question. I think what we said previously is that we’re looking at all options there very carefully and very thoughtfully, taking into account all the different levers, and if you will, pulls and puts that are involved in potentially partnering something ex-US. Still under evaluation. We have lots of options, lots of interest. Certainly, we expect that to continue to grow as we turn over more cards, hopefully positive in terms of pivotal trials. Stay tuned.

是的。我是 Mike。謝謝你的問題。我想我們先前說過的是，我們正在非常謹慎且周全地評估所有選項，並把所有不同的槓桿因素都納入考量；也就是說，若要在美國以外（ex-US）為某項產品尋求合作，會涉及各種利弊權衡（pulls and puts）。目前仍在評估中。我們有很多選項，也有很多興趣。當然，我們預期隨著我們揭露更多資訊——希望在關鍵性試驗（pivotal trials）方面是正面的——這些興趣會持續增加。敬請期待。

Ash Verma, UBS.

Ash Verma，UBS。

Just going back to the STELLAR-303 study in CRC. What is your best guess in terms of what might have driven this recent update that the non-liver Mets subgroup did not achieve statistical OS benefit? Is it possible some subgroup analysis was underpowered, or is it anything to do with atezo that might see some diminishing efficacy? Have you discussed this with the regulatory agency as a part of your ongoing review?

回到 CRC 的 STELLAR-303 研究。你們對於近期更新中「非肝轉移（non-liver Mets）亞組未達到整體存活期（OS）統計學效益」的可能原因，最佳推測是什麼？是否可能是某些亞組分析的統計力不足（underpowered），或是與 atezo 相關、導致療效可能出現遞減？在你們持續審查的過程中，是否已就此與主管機關討論過？

Dana?

Dana？

Sure. Thanks for the question, Ash. So yes, regarding the non-liver Mets primary endpoint, as we announced in June, that endpoint essentially did not meet statistical significance. Although I’d say that the treatment effect was very similar to when we announced the interim results of that endpoint last year when we released the data on the ITT population.

當然。謝謝你的問題，Ash。是的，關於非肝轉移（non-liver Mets）的主要終點，如我們在 6 月宣布的，該終點基本上未達到統計顯著性。不過我會說，治療效果與我們去年公布該終點的期中結果、以及我們發布 ITT 族群數據時所見到的結果非常相近。

Basically, over time, we really didn’t see the data evolve to a point where it became significant. As you mentioned, you pointed to one potential factor there, that this was a very small subpopulation of the study. The most important thing to us is that the ITT population is the overall population. The entire population in the study, it includes both liver Mets patients and non-liver Mets patients, and those are the data that were the subject of the NDA that we submitted to the regulatory agency.

基本上，隨著時間推移，我們並未看到數據演變到達到顯著性的程度。如你所提到的，其中一個可能因素是：這是研究中非常小的次族群。對我們而言最重要的是 ITT 族群，也就是整體族群。研究的整體族群包含肝轉移病患與非肝轉移病患，而這些數據正是我們提交給主管機關之 NDA 的核心內容。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

I guess persistency with oral TKIs as maintenance therapy has historically been somewhat challenging across a number of different tumor types for various agents, I think mostly related to reasons that P.J. cited when he was talking about adjuvant RCC. Just curious, what can you do in these STELLAR-316 and STELLAR-202 trials to make sure that persistency doesn’t end up confounding data interpretation?

我想口服 TKI 作為維持治療的持續用藥（persistency）在歷史上一直相當具挑戰性，涵蓋多種不同腫瘤類型與不同藥物；我認為多半與 P.J. 在談到輔助治療 RCC 時所提到的原因有關。想請教，在這些 STELLAR-316 與 STELLAR-202 試驗中，你們能做些什麼來確保持續用藥不會最終干擾（confounding）數據解讀？

Let me start, and Dana or P.J. can opine if needed. I think the key there is really around picking the right dose, and taking into account the patient population, their kind of general performance status, and what they’re progressing from or after their last treatment to be able to maximize any potential clinical benefit and therapeutic ratio.

我先回答，如果需要的話 Dana 或 P.J. 也可以補充。我認為關鍵在於選擇正確的劑量，並將病患族群、其整體體能狀態（performance status），以及他們是從何種治療進展而來或在最後一次治療之後的狀態納入考量，以便最大化任何潛在的臨床效益與治療比（therapeutic ratio）。

We feel like we’ve got a really good handle on that. Obviously, we have a lot of experience there with cabo from the standpoint of picking a lower dose with 9ER and really kind of looking at the temporal aspect of clinical benefit as opposed to an early response rate which then you pay for later with potentially more tox.

我們覺得自己對此掌握得相當好。顯然，我們在 cabo 上有很多經驗：從 9ER 的角度來看，選擇較低劑量，並且更著重於臨床效益的時間面向，而不是只看早期反應率——因為那樣可能在後期要付出代價，出現更多潛在毒性（tox）。

It’s really balancing short-term activity with long-term duration to be able to give benefit. Some of the earlier maybe first generation or two of TKIs had some challenges there. We feel really good about that with zanza relative to the target inhibition profile, the pharmacodynamics, the short half-life. With, whether it be STELLAR-316 or STELLAR-202 or even STELLAR-201, we feel like we’ve got pretty good insight to be able to maximize that opportunity.

這其實是在短期活性與長期持續時間之間取得平衡，才能帶來效益。較早期、可能第一或第二代的 TKI 在這方面確實有一些挑戰。相較之下，我們對 zanza 很有信心，因為它的標的抑制特徵、藥效動力學（pharmacodynamics）以及較短的半衰期。無論是 STELLAR-316、STELLAR-202，甚至 STELLAR-201，我們都覺得我們已有相當好的洞見，能夠把握並最大化這個機會。

Thank you. And at this time, there are no further questions. So I will turn the call back over to today's host, Mr. Andrew Peters.

謝謝。目前沒有其他問題。因此我將把電話交回給今天的主持人 Andrew Peters 先生。

Thank you, Kathleen, 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. Have a good rest of your day.

謝謝你，Kathleen，也謝謝各位今天參與。若各位還有任何我們在今天電話會議中未能回答的其他問題，歡迎會後來電追問。祝各位今天剩餘時間愉快。

Ladies and gentlemen, that concludes today's call. Thank you, everyone, for joining. You may now disconnect.

各位女士、先生，今天的電話會議到此結束。謝謝大家參與。您現在可以掛線。