Exelixis Inc (EXEL) 2025 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Exelixis first quarter 2025 financial results conference call. My name is Towanda, and I will 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 年第一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, Ms. 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 first 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; P.J. 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 first quarter 2025 ended March 31, 2025.

謝謝你，Towanda，也謝謝大家參加 Exelixis 2025 年第一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； Chris Senner，我們的財務長； P.J. Haley，我們的商業執行副總裁；我們的首席醫療官艾米·彼得森 (Amy Peterson)；以及我們的首席科學官 Dana Aftab，他將審查我們截至 2025 年 3 月 31 日的 2025 年第一季的進展。

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, and government drug pricing policies and initiatives.

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、財務和策略事務以及政府藥品定價政策和舉措的可能發展的聲明。

Actual events or results could differ materially. 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 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 cost associated with discovery, product development, business development, and commercialization activities.

實際事件或結果可能有重大差異。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、我們對合作夥伴的依賴以及與發現、開發

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

說完這些，我想把電話轉給麥克。

All right. Thank you, Susan, and thanks to everyone for joining us on the call today.

好的。謝謝你，蘇珊，也謝謝大家今天參加我們的電話會議。

Exelixis had a strong first quarter, highlighted by significant progress and momentum across all components of our business. We continue to execute on our strategy to build a multi-compound, multi-franchise oncology enterprise. We expect 2025 to be a very busy and highly productive time for the company.

Exelixis 在第一季表現強勁，業務各個組成部分均取得了顯著進展並呈現強勁勢頭。我們將繼續執行我們的策略，打造一個多化合物、多特許經營的腫瘤學企業。我們預計 2025 年對公司來說將是一個非常忙碌且有效率的時期。

I think it's safe to say that we have reached another critical inflection point in recent Exelixis history, and we're energized to take things to the next level as we move forward into the second quarter and beyond. As we discussed previously, we have a singular focus on improving the standard of care for patients with cancer. Our future success in achieving this goal will enable Exelixis to help many more cancer patients and ultimately solidify our leadership position through innovation and execution.

我認為可以肯定地說，我們已經達到了 Exelixis 近期歷史上的另一個關鍵轉折點，隨著我們進入第二季度及以後，我們有動力將事情提升到一個新的水平。正如我們之前討論過的，我們專注於提高癌症患者的護理標準。我們未來成功實現這一目標將使 Exelixis 能夠幫助更多的癌症患者，並最終透過創新和執行來鞏固我們的領導地位。

We're pleased to see accelerating growth of the US cabo franchise in the first quarter, both in terms of absolute revenue and relative growth compared to the competition, which reflects cabo's status as the leading TKI for RCC. We anticipate seeing additional upside with new indications in neuroendocrine tumors, where we secured regulatory approval at the end of March.

我們很高興看到美國 cabo 特許經營權在第一季加速成長，無論是絕對收入還是與競爭對手相比的相對增長，這反映了 cabo 作為 RCC 領先 TKI 的地位。我們預計神經內分泌腫瘤的新適應症將帶來更多好處，我們已於三月底獲得該領域的監管部門批准。

Key highlights for the first quarter include: first, we saw a strong performance of the cabozantinib US business with continued growth in demand, new starts, and revenue. First quarter 2025 US cabo franchise net product revenues grew 36% year over year to $513 million compared to $378 million in the first quarter of 2024.

第一季的主要亮點包括：首先，我們看到卡博替尼美國業務表現強勁，需求、新開工和收入持續成長。2025 年第一季美國卡波特許經營淨產品營收年增 36% 至 5.13 億美元，而 2024 年第一季為 3.78 億美元。

The global cabo franchise net product revenues generated by Exelixis and its partners were approximately $680 million in the first quarter of 2025 compared to $559 million in the first quarter of 2024. Given the strong momentum of CABOMETYX in the first quarter, we're increasing our 2025 full year financial guidance for net product revenues and total revenues by $100 million.

2025 年第一季度，Exelixis 及其合作夥伴創造的全球 cabo 特許經營淨產品收入約為 6.8 億美元，而 2024 年第一季為 5.59 億美元。鑑於 CABOMETYX 在第一季的強勁勢頭，我們將 2025 年全年淨產品收入和總收入的財務預期提高 1 億美元。

Second, on top of our strong financial and commercial performance, the highlight of the quarter was the US regulatory approval of CABOMETYX in both pNET and epNET, ahead of our assigned PDUFA date of April 3, 2025. Our commercial team was ready to execute our detailed launch plan, and we were out in the field within hours of approval. PJ will provide more information and commentary about our first quarter commercial dynamics and the NET launch in his prepared remarks.

其次，除了我們強勁的財務和商業表現之外，本季度的亮點是美國監管機構批准 CABOMETYX 用於治療 pNET 和 epNET，這比我們指定的 PDUFA 日期 2025 年 4 月 3 日提前。我們的商業團隊已準備好執行詳細的發布計劃，並在獲得批准後的幾個小時內就出發了。PJ 將在其準備好的發言中提供更多有關我們第一季商業動態和 NET 發布的信息和評論。

We plan 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 2025.

隨著 NET 發布的勢頭增強，以及對 2025 年額外收入機會的進一步明確，我們計劃對 2025 年財務指導的進一步更新進行評估。

Third, it's mission-critical for us to advance new molecules from our pipeline into full development and ultimately, onto the market to excel in our mission to help cancer patients recover stronger and live longer. We're excited to advance zanza to the center stage in 2025 as our next oncology franchise opportunity.

第三，對我們來說，至關重要的是推動新分子從我們的研發管線進入全面開發階段，並最終將其推向市場，以更好地完成我們的使命，幫助癌症患者恢復得更強、壽命更長。我們很高興能夠在 2025 年將 zanza 推向中心舞台，成為我們的下一個腫瘤學特許經營機會。

Important anticipated zanza data milestones from pivotal trials in the second half of 2025 include top line results from STELLAR-303 in colorectal cancer and STELLAR-304 in non-clear cell RCC and a decision to advance the Phase III portion of STELLAR-305 in head and neck cancer - all pending event rates for each trial.

2025 年下半年關鍵試驗中預期的重要 zanza 數據里程碑包括 STELLAR-303 在結直腸癌和 STELLAR-304 在非透明細胞 RCC 中的頂線結果，以及決定推進 STELLAR-305 在頭頸癌中的 III 期部分 - 所有待定事件率均取決於每個試驗。

In addition, we expect to initiate the STELLAR-311 trial of zanza in NET in the first half of 2025 and anticipate Merck will initiate two RCC studies evaluating zanza plus belzutifan this year.

此外，我們預計將於 2025 年上半年啟動 zanza 在 NET 中的 STELLAR-311 試驗，並預計默克公司將在今年啟動兩項評估 zanza 和 belzutifan 的 RCC 研究。

Fourth, as we highlighted recently, our Exelixis IND pipeline is coming into focus with a range of new and potentially differentiated molecules heading into and through early clinical evaluation. The goal of these efforts isn't to build a big pipeline, it's to carefully and quickly evaluate new clinical assets and identify the winners for advancement into full development as top investment priorities.

第四，正如我們最近強調的那樣，我們的 Exelixis IND 管道正逐漸成為焦點，一系列新的、具有潛在差異化的分子正在進入並通過早期臨床評估。這些努力的目標不是建立龐大的研發管線，而是仔細、快速地評估新的臨床資產，並確定可推進全面開發的贏家，作為首要投資重點。

Early development of XL309 continues to be a main focus as both a monotherapy and in combination with PARP inhibitors to deepen and prolonged responses. Dose escalation with XB010 continues to advance quickly. We're making good progress on our goal to file up to three new INDs in 2025. XB628 recently entered the clinic, and we remain on track for IND submissions for XB064 and XB371 this year.

XL309 的早期開發仍然是主要關注點，它既可以作為單一療法，也可以與 PARP 抑制劑聯合使用，以深化和延長療效。XB010 的劑量遞增繼續快速推進。我們在實現 2025 年提交最多三個新 IND 的目標方面取得了良好進展。XB628 最近進入臨床階段，我們今年仍將按計劃提交 XB064 和 XB371 的 IND 申請。

Finally, in regard to capital allocation, we're excited about the trajectory of our business and have the balance sheet and expect the cash flow to advance our pipeline priorities, access new high conviction assets, and continue to repurchase shares when we believe they are undervalued.

最後，關於資本配置，我們對業務的發展軌跡感到興奮，並擁有資產負債表，並預計現金流將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。

Business development activities continue in earnest and are focused on late-stage assets in the GU/GI space. Back-end loaded pay-for-success transactions that tuck nicely into our existing and potential future oncology franchise remain a top priority. As always, we're focused on doing the right deals for the right assets at the right valuations.

業務開發活動繼續認真進行，並專注於 GU/GI 領域的後期資產。後端付費成功交易可以很好地融入我們現有和未來潛在的腫瘤學特許經營，這仍然是我們的首要任務。像往常一樣，我們專注於以正確的估值對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 first 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 2025 年第一季的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.

謝謝，麥克。

For the first quarter of 2025, the company reported total revenues of approximately $555 million, which included cabozantinib franchise net product revenues of $513.3 million. CABOMETYX net product revenues were $510.9 million and included approximately $12 million in clinical trial sales. As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future.

2025 年第一季度，該公司報告總收入約為 5.55 億美元，其中包括卡博替尼特許經營淨產品收入 5.133 億美元。CABOMETYX 淨產品收入為 5.109 億美元，其中包括約 1,200 萬美元的臨床試驗銷售額。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。

Gros- to-net for the cabozantinib franchise in the first quarter of 2025 was 28.9%, which is higher than the gross-to-net we experienced in the fourth quarter of 2024. This increase in gross-to-net deductions in the first quarter of 2025 is primarily related to higher PHS and 340B volumes in the quarter.

2025 年第一季卡博替尼特許經營權的總淨利潤率為 28.9%，高於 2024 年第四季的總淨利潤率。2025 年第一季總扣除額至淨扣除額的增加主要與該季度 PHS 和 340B 交易量的增加有關。

As previously disclosed, Exelixis has qualified as a specified small manufacturer for the phase-in period, which requires Exelixis to pay a 1% discount in 2025 on all Medicare Part D sales and is included in our gross-to-net estimates for the year.

如前所述，Exelixis 已獲得過渡期指定小型製造商的資格，這要求 Exelixis 在 2025 年對所有 Medicare Part D 銷售支付 1% 的折扣，並包含在我們當年的毛利與淨利估算中。

Our inventory at the end of the first quarter 2025 was approximately two weeks on hand, which was down slightly when compared to the fourth quarter of 2024. Because of this relatively flat inventory dynamic between the fourth quarter 2024 and first quarter 2025, we experienced little inventory destocking in the first quarter of 2025.

截至 2025 年第一季末，我們的庫存約為兩週，與 2024 年第四季相比略有下降。由於 2024 年第四季和 2025 年第一季之間的庫存動態相對平穩，因此 2025 年第一季的庫存去化程度較低。

Total revenues also included approximately $42 million in collaboration revenues which includes approximately $36.7 million of royalties earned from our partners Ipsen and Takeda on their sales of cabozantinib in their respective territories. Our total operating expenses for the first quarter of 2025 were approximately $369 million compared to $404 million in the fourth quarter 2024. The sequential decline in these operating expenses was primarily driven by lower clinical trial costs, manufacturing costs for drug development candidates, and licensing costs.

總收入還包括約 4,200 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 3,670 萬美元的特許權使用費。我們 2025 年第一季的總營運費用約為 3.69 億美元，而 2024 年第四季為 4.04 億美元。這些營運費用的連續下降主要是由於臨床試驗成本、藥物開發候選物的製造成本和許可成本的下降。

These lower R&D costs were offset by higher general and administrative costs in the first quarter of 2025. Provision for income taxes for the first quarter of 2025 was approximately $46.1 million compared to a provision for income taxes of approximately $44.9 million for the fourth quarter 2024.

2025 年第一季度，這些較低的研發成本被較高的一般和行政成本所抵銷。2025 年第一季的所得稅準備金約為 4,610 萬美元，而 2024 年第四季的所得稅準備金約為 4,490 萬美元。

The company reported GAAP net income of approximately $159.6 million or $0.57 per share basic and $0.55 per share diluted for the first quarter 2025. The company also reported a non-GAAP net income of approximately $179.6 million or $0.64 per share basic and $0.62 per share diluted. Non-GAAP net income excludes the impact of approximately $20 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the quarter ended March 31, 2025, was approximately $1.65 billion.

該公司報告稱，2025 年第一季 GAAP 淨收入約為 1.596 億美元，即每股基本收入 0.57 美元，每股攤薄收入為 0.55 美元。該公司還報告非公認會計準則淨收入約為 1.796 億美元，即每股基本淨收入 0.64 美元，每股攤薄淨收入為 0.62 美元。非公認會計準則淨收入不包括約 2,000 萬美元的股票薪資費用扣除相關所得稅的影響。截至 2025 年 3 月 31 日的季度，現金和有價證券約為 16.5 億美元。

During the first quarter of 2025, we repurchased approximately $289 million of the company's shares, resulting in the retirement of approximately $8 million of the company's shares at an average price per share of $35.83. As of the end of the first quarter of 2025, we had approximately $5.5 million remaining under the $500 million stock repurchase plan authorized by the company's board in August 2024. In February 2025, the board authorized an additional $500 million stock repurchase plan that expires at the end of 2025. We have been purchasing shares under the February 2025 plan during the second quarter.

2025 年第一季度，我們回購了約 2.89 億美元的公司股票，導致約 800 萬美元的公司股票以每股平均 35.83 美元的價格退出。截至 2025 年第一季末，根據公司董事會於 2024 年 8 月批准的 5 億美元股票回購計劃，我們還剩餘約 550 萬美元。2025 年 2 月，董事會批准了一項額外的 5 億美元股票回購計劃，將於 2025 年底到期。我們第二季一直在按照 2025 年 2 月計劃購買股票。

Now turning to our net product revenue and total revenue financial guidance for the full year 2025. We're increasing our net product and total revenue guidance given CABOMETYX's strong performance in the first quarter and our expectations of continued strong performance throughout 2025. We're increasing our net product revenue guidance to $2.05 billion to $2.15 billion, which increases the midpoint of our net product revenue guidance range by $100 million when compared to our previously provided net product revenue guidance. We are also making a corresponding increase to our total revenue guidance, which is now $2.25 billion to $2.35 billion.

現在談談我們 2025 年全年的淨產品收入和總收入財務指引。鑑於 CABOMETYX 在第一季的強勁表現以及我們對 2025 年全年持續強勁表現的預期，我們提高了淨產品和總收入預期。我們將淨產品收入預期上調至 20.5 億美元至 21.5 億美元，與我們先前提供的淨產品收入預期相比，這將使我們的淨產品收入預期範圍的中點增加 1 億美元。我們也相應提高了總收入預期，目前為 22.5 億美元至 23.5 億美元。

And finally, regarding the impact of tariffs on our business. As we said previously, our IP for both cabozantinib and zanzalintinib is domiciled, and as of now, we are projecting minimal exposure on our US cabozantinib business. Our cost of goods sold is approximately 4% of net product revenue, and 3 of those 4 percentage points is royalty owed to a third party. The vast majority of cabozantinib finished product for US distribution is manufactured in Canada, and any potential tariff impact on the remaining 1% would be de minimis to the overall business.

最後，關於關稅對我們業務的影響。正如我們之前所說，卡博替尼和讚札林替尼的智慧財產權均已在美國境內，截至目前，我們預期美國卡博替尼業務的風險敞口很小。我們的銷售成本約佔淨產品收入的 4%，其中 3 個百分點是欠第三方的特許權使用費。美國分銷的卡博替尼成品絕大多數是在加拿大生產的，對剩餘 1% 的任何潛在關稅影響對整體業務的影響都是微乎其微的。

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

說完這些，我將把電話轉給 P.J.

Thank you, Chris.

謝謝你，克里斯。

As Mike highlighted, the CABOMETYX business was very strong in the first quarter of 2025. Importantly, CABOMETYX received approvals in neuroendocrine tumors on March 26th. Cabo grew 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, and this has resulted in CABOMETYX continuing to be the number one prescribed TKI in renal cell carcinoma as well as the number one TKI plus IO combination in first-line RCC.

正如 Mike 所強調的，CABOMETYX 業務在 2025 年第一季表現非常強勁。重要的是，CABOMETYX於3月26日獲得了神經內分泌腫瘤治療領域的批准。Cabo 在收入、需求和新患者數量方面均有所增長，並且相對於競爭對手錶現尤為出色。團隊繼續以極高的水平執行，這使得 CABOMETYX 繼續成為腎細胞癌中處方量第一的 TKI，以及一線 RCC 中第一的 TKI 加 IO 組合。

The commercial team is executing the launch in NETs with great urgency and 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 to address the unmet need in neuroendocrine tumors as we look to build on the strong momentum of the CABOMETYX business.

商業團隊正在緊急執行 NET 的發布，目標是迅速將 CABOMETYX 確立為 NET 領域小分子市場的領導者。我們很高興看到處方醫生對這些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解決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 TKI market basket of cabo, lenvatinib, axitinib, sunitinib, and pazopanib made the strength of cabo relative to the competition. Looking at the TRx comparison, Q1 2024 to Q1 2025, CABOMETYX grew 4 share points from 40% to 44%. Importantly, cabo is the only product in the market basket to grow market share.

卡博替尼、侖伐替尼、阿昔替尼、舒尼替尼和帕唑帕尼的 TKI 市場組合中的處方數據決定了卡博替尼相對於競爭對手的優勢。從 TRx 比較來看，2024 年第一季至 2025 年第一季度，CABOMETYX 的份額增加了 4 個百分點，從 40% 成長至 44%。重要的是，cabo 是市場籃子中唯一市場份額成長的產品。

CABOMETYX TRx volume grew 18% in this time period, outpacing the growth rate of the market by 10 percentage points, which was the only product that grew at a rate greater than the market. The CheckMate -9ER 5-year follow-up data presented at GU ASCO in February, has been resonating very well with prescribers in the RCC space. These data help our team continue to drive differentiation from the competition in the first-line RCC market.

CABOMETYX TRx 的銷售量在此期間成長了 18%，超過市場成長率 10 個百分點，是唯一成長率高於市場的產品。CheckMate -9ER 於 2 月在 GU ASCO 上公佈的 5 年追蹤數據得到了 RCC 領域處方醫生的強烈反響。這些數據有助於我們的團隊繼續在一線 RCC 市場中保持與競爭對手的差異化。

Turning to new prescriptions, or NRx, CABOMETYX had even stronger data trends. CABOMETYX NRx share in the TKI market basket went from 38% in Q1 2024 to 43% in Q1 2025. This share gain is even more impressive as every other product in the market basket lost share in the same time period.

談到新處方或 NRx，CABOMETYX 的數據趨勢更為強勁。CABOMETYX NRx 在 TKI 市場中的份額從 2024 年第一季的 38% 增長至 2025 年第一季的 43%。由於同一時期內市場籃子中的其他所有產品的份額都在下降，因此這一份額增長更加令人印象深刻。

NRx volume for CABOMETYX grew 27% year over year. We believe this strength in new prescriptions, which outpaces the total prescription growth of 18% is an indicator that the business is well positioned to continue the strong momentum going forward. Furthermore, the new indications in NETs will add to the current momentum of the business.

CABOMETYX 的 NRx 銷量年增 27%。我們相信，新處方的成長勢頭強勁，超過了 18% 的總處方成長，這表明該業務已做好準備，並繼續保持強勁的發展勢頭。此外，NET 的新適應症將增強當前的業務發展勢頭。

We are thrilled that CABOMETYX is approved for appropriate patients in neuroendocrine tumors. As we have discussed previously, we see this as a compelling commercial opportunity for Exelixis and the CABOMETYX brand. Based upon market research, we believe that there will be approximately 9,000 drug-treated patients in the second- and third-lines in the US in 2025, and this is expected to grow to approximately 11,000 by 2030.

我們非常高興 CABOMETYX 被批准用於治療適合的神經內分泌腫瘤患者。正如我們之前所討論的，我們認為這對 Exelixis 和 CABOMETYX 品牌來說是一個極具吸引力的商業機會。根據市場調查，我們認為2025年美國二線和三線藥物治療患者將達到約9,000人，預計2030年將成長至約11,000人。

Our research also indicates that the majority of the second- and third-line patients receive oral small molecules as their standard of care. Furthermore, as we have previously discussed, the oral market opportunity in 2025 is forecasted to be approximately $1 billion in the US.

我們的研究還表明，大多數二線和三線患者接受口服小分子藥物作為標準治療。此外，正如我們之前討論過的，預計 2025 年美國口腔市場規模約為 10 億美元。

Recall that the target NET physician universe has significant overlap with legacy CABOMETYX prescribers. We believed that this overlap, coupled with our sales team's deep relationships, would accelerate access and promotional opportunities, and we are pleased to see this come to fruition as our team called on more than 70% of the 3,500 NET prescriber and NET physician targets in the first three weeks post-approval.

回想一下，目標 NET 醫師群體與傳統的 CABOMETYX 處方者有很大的重疊。我們相信，這種重疊加上我們銷售團隊的深厚關係將加速獲取和促銷機會，我們很高興看到這一成果，因為我們的團隊在批准後的前三週內就聯繫到了 3,500 名 NET 處方者和 NET 醫生目標中的 70% 以上。

As we have previously discussed, the CABINET study uniquely positions CABOMETYX across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas, GI tract and lung across all tumor grades from 1 to 3 functional status, STR status, and those who have received prior treatment with Lutathera. The unique study population led to strong and broad NCCN guideline recommendations for CABOMETYX as a preferred or recommended option regardless of site of origin or tumor grade for patients who received prior therapy.

正如我們之前所討論的，CABINET 研究根據患者和腫瘤特徵對 CABOMETYX 進行了獨特的定位，包括胰腺、胃腸道和肺部神經內分泌腫瘤患者，所有腫瘤等級從 1 至 3，功能狀態、STR 狀態，以及曾接受過 Lutathera 治療的患者。獨特的研究族群導致 NCCN 指南對 CABOMETYX 提出了強而有力且廣泛的建議，將其作為接受過先前治療的患者的首選或推薦選擇，無論其起源部位或腫瘤等級如何。

We are pleased with the CABOMETYX label, which will allow physicians to prescribe CABOMETYX to a wide range of NET patients who have received prior therapy. Importantly, this approval makes CABOMETYX the first and only systemic treatment that is FDA-approved for previously treated NET regardless of site of origin or patient's functional status.

我們對 CABOMETYX 標籤感到滿意，這將允許醫生為廣泛的接受過先前治療的 NET 患者開出 CABOMETYX。重要的是，此次批准使 CABOMETYX 成為 FDA 批准的第一個也是唯一一個用於治療既往接受過治療的 NET 的全身性治療藥物，無論其起源部位或患者的功能狀態如何。

The team had been launch ready for some time prior to approval and literally hit the ground sprinting when cabo received the NET indications. The CABOMETYX data and messages are resonating well, and prescriber reception has been extremely positive and confirmatory of the unmet medical need in the neuroendocrine tumor space. Our core promotional assets were deployed within days, if not hours of approval, including personal promotional pieces, the website, targeted nonpersonal digital and social media tactics, peer-to-peer education as well as patient and allied healthcare professional educational materials.

在獲得批准之前，團隊已經做好了啟動準備，當 cabo 收到 NET 指示時，他們立即開始衝刺。CABOMETYX 的數據和資訊引起了良好的共鳴，處方者的接受度也非常積極，證實了神經內分泌腫瘤領域尚未滿足的醫療需求。我們的核心宣傳資產在批准後的幾天甚至幾小時內就部署完畢，包括個人宣傳品、網站、有針對性的非個人數位和社交媒體策略、點對點教育以及患者和相關醫療專業人員的教育材料。

Teams mobilized and are already working to quickly establish CABOMETYX as the new standard of care for second- and third-line NET patients. We are also pleased that the indication is providing us great access to customers, so we're able to discuss both the CABINET data as well as the RCC CheckMate -9ER 5-year follow-up data for relevant physicians. 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.

團隊已動員起來並正在努力迅速將 CABOMETYX 確立為二線和三線 NET 患者的新護理標準。我們也很高興該適應症為我們提供了接觸客戶的良好途徑，因此我們能夠與相關醫生討論 CABINET 數據以及 RCC CheckMate -9ER 5 年隨訪數據。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。

In general, prescribers see CABOMETYX as a more favorable choice versus current small molecule therapies. Additionally, the competition in the oral segment of the NET market are all generic therapies, which puts CABOMETYX at a significant advantage with a full commercial organization in support of the launch. All of this taken together drives our conviction that the NET market will be a substantial opportunity for the CABOMETYX business.

整體而言，處方醫生認為 CABOMETYX 是比目前的小分子療法更有利的選擇。此外，NET 市場口服藥物領域的競爭都是仿製藥，這使得 CABOMETYX 擁有明顯的優勢，因為它擁有完整的商業組織來支持該產品的上市。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。

With that, I will turn the call over to Amy.

說完這些，我會把電話轉給艾米。

Thank you, P.J. Everyone at Exelixis shares your excitement around the recent approval of cabozantinib in patients with either pancreatic or extrapancreatic neuroendocrine tumors.

謝謝你，P.J. Exelixis 的每個人都和你一樣，對卡博替尼最近獲批用於治療胰腺或胰腺外神經內分泌腫瘤患者感到興奮。

This approval came approximately one week prior to the PDUFA date thanks to the team interacting seamlessly with the FDA and the Alliance Cooperative Group. With this major accomplishment now behind us, the CABINET team is able to shift focus towards helping our partner, Ipsen, obtain ex-US approvals. As a reminder, this application was chosen for Project Orbi , an FDA initiative that can facilitate approvals in participating countries around the globe.

由於團隊與 FDA 和聯盟合作集團的無縫互動，此次批准比 PDUFA 日期提前了大約一周。在取得這一重大成就後，CABINET 團隊能夠將重點轉向幫助我們的合作夥伴 Ipsen 獲得美國以外的批准。提醒一下，此應用程式被選為 Orbi 項目，這是 FDA 的一項計劃，可以促進全球參與國的審批。

Looking ahead, 2025 is shaping up to be a very big year not just for cabozantinib but also for zanzalintinib given the breadth of data readouts and pivotal trial initiations anticipated. First, I want to remind you of why we are optimistic about zanzalintinib's potential to become a best-in-class VEGFR TKI.

展望未來，鑑於預期的數據讀取範圍和關鍵試驗的啟動，2025 年不僅對卡博替尼來說非常重要，對於贊扎林替尼來說也是如此。首先，我想提醒大家為什麼我們對 zanzalintinib 成為同類最佳 VEGFR TKI 的潛力持樂觀態度。

While zanza's target profile is similar to cabo's, its half-life is much shorter, enabling faster recovery from treatment-related adverse events with dose modifications and possibly favoring tumor accumulation over platinum concentration as was observed in nonclinical models and presented at AACR last year. Either of these qualities could result in an improved therapeutic index for zanzalintinib.

雖然 zanza 的目標曲線與 cabo 相似，但其半衰期要短得多，因此可以透過調整劑量更快地從治療相關不良事件中恢復，並且可能有利於腫瘤蓄積而不是鉑濃度，正如非臨床模型中觀察到的以及去年在 AACR 上提出的那樣。這兩種特性中的任何一種都可以提高 zanzalintinib 的治療指數。

In terms of pivotal data readouts, the first trial we anticipate data from is STELLAR-303. This Phase III study compares the combination of zanzalintinib plus atezolizumab to regorafenib in patients who have received multiple prior therapies for their advanced colorectal cancer. The trial is designed to assess outcomes in the population of patients without liver metastases, referred to as NLM, and in the intent-to-treat, or ITT, population.

就關鍵數據讀數而言，我們預計從 STELLAR-303 試驗中獲得數據。這項 III 期研究比較了 zanzalintinib 加 atezolizumab 與瑞戈非尼聯合治療晚期大腸直腸癌患者的療效，這些患者之前均接受過多種療法。該試驗旨在評估無肝轉移患者群體（稱為 NLM）和意圖治療族群（或 ITT）的治療結果。

At ASCO GI in January of this year, we presented encouraging clinical data from the STELLAR-001 expansion colorectal cohorts evaluating zanza with or without atezo. As seen in STELLAR-001, and frankly in all other colorectal trials, patients without liver metastases tend to live longer than those with liver metastases regardless of treatment intervention.

在今年 1 月的 ASCO GI 上，我們展示了 STELLAR-001 擴展結直腸隊列的令人鼓舞的臨床數據，評估了 zanza 與或不與 atez 聯合使用的效果。如同在 STELLAR-001 以及坦白說在所有其他結直腸試驗中所見，無論治療介入如何，沒有肝轉移的患者往往比有肝轉移的患者壽命更長。

We announced completion of enrollment in STELLAR-303 in the second quarter of last year. Given the maturity of follow-up time in the intent-to-treat population, we anticipate being able to perform the overall survival analysis in the ITT simultaneous with the overall survival analysis in the non-liver NET population. We have amended the statistical analysis plan to dual primary endpoints in NLM and ITT, and top line data remains on track for the second half of 2025, events pending.

我們在去年第二季宣布完成 STELLAR-303 的招生。鑑於意向治療族群的追蹤時間成熟度，我們預計能夠同時進行 ITT 中的整體存活分析和非肝臟 NET 族群中的整體存活分析。我們已將統計分析計劃修改為 NLM 和 ITT 中的雙重主要終點，並且 2025 年下半年的頂線數據仍將保持正軌，但事件有待解決。

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 renal cell carcinoma. The primary endpoints in this study are progression-free survival as assessed by blinded independent central radiology and objective response rates by RECIST. We expect to wrap up enrollment this quarter and anticipate data in the second half of 2025, again, events pending.

STELLAR-304 是我們的關鍵研究，旨在評估 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腎細胞癌全身治療的患者。本研究的主要終點是透過盲法獨立中心放射學評估的無惡化存活期和透過 RECIST 評估的客觀反應率。我們預計將於本季完成招生，並預計在 2025 年下半年獲得數據，同樣，事件有待解決。

Also in the second half of 2025, we expect the Phase III go-no-go decision for STELLAR-305, our Phase II/III study comparing zanzalintinib plus pembrolizumab to placebo plus pembrolizumab in patients who have not yet received systemic therapy for their advanced PD-L1 expressing squamous cell carcinoma of the head and neck. Merck is supplying pembrolizumab for this trial as part of our collaboration agreement.

此外，在 2025 年下半年，我們預計將對 STELLAR-305 做出 III 期臨床試驗的通過與否決定，這是我們的 II/III 期研究，比較了 zanzalintinib 聯合 pembrolizumab 與安慰劑聯合 pembrolizumab 在尚未接受全身性頭部治療的晚期 PD-L1 表達。作為合作協議的一部分，默克將為此次試驗提供派姆單抗。

As for new trial starts, STELLAR-311, our pivotal study comparing zanzalintinib to everolimus as the first oral therapy in patients with neuroendocrine tumors, is on track to initiate this quarter. And Merck is making steady progress with their Phase II and Phase III studies in clear cell renal cell carcinoma with anticipated starts in the second half of 2025.

至於新試驗的開始，STELLAR-311 是我們的關鍵研究，比較了 zanzalintinib 與依維莫司作為神經內分泌腫瘤患者的首個口服療法，該研究將於本季度啟動。默克公司在透明細胞腎細胞癌的 II 期和 III 期研究正在穩步進展，預計將於 2025 年下半年開始。

Finally, we are proud to have numerous presentations at ASCO 2025, including three involving zanza. As you can imagine, we're excited about zanza's potential and expect 2025 to be a very data-rich year. I'll leave you with that and turn the call over to Dana.

最後，我們很榮幸能在 ASCO 2025 上進行多場演講，其中三場是 zanza。你可以想像，我們對 zanza 的潛力感到非常興奮，並預計 2025 年將是數據非常豐富的一年。我就把這個留給你，然後把電話轉給達娜。

Thanks, Amy, and good afternoon, everyone. Today, I'm giving a brief update on our recent progress toward IND filings and advancing new compounds to development candidate status, and I'll close with an update on the XL495 program.

謝謝，艾米，大家下午好。今天，我將簡要介紹我們在 IND 申請和推進新化合物開發候選狀態方面的最新進展，最後我將介紹 XL495 計劃的最新進展。

On the IND front, we've continued to make good progress on all of our pre-IND programs, and we are on track to file up to three this year. As you saw in the press release, we filed the IND for XB628 in the first quarter of this year, and the Phase I trial is now open and recruiting. XB628 is a bispecific antibody that targets NKG2A and PD-L1, two separate immune checkpoint proteins that tumors use to overcome innate and adaptive antitumor immune responses.

在 IND 方面，我們在所有 IND 前專案上繼續取得良好進展，並且我們預計今年將提交多達三個專案。正如您在新聞稿中看到的，我們在今年第一季提交了 XB628 的 IND，第一階段試驗現已開放並正在招募患者。XB628 是一種雙特異性抗體，針對 NKG2A 和 PD-L1，這兩種獨立的免疫檢查點蛋白被腫瘤用來克服先天性和適應性抗腫瘤免疫反應。

And because PD-L1 is expressed on tumor cells, while NKG2A is expressed on natural killer or NK cells, XB628 potentially can also act as an NK cell engager for tumors. As we demonstrated in our presentation last month at AACR, in preclinical models XB628 causes tumor cells and NK cells to co-localize resulting in tumor cell kill that is substantially higher than that seen with a combination of two monoclonals that separately target NKG2A and PD-L1.

由於 PD-L1 在腫瘤細胞上表達，而 NKG2A 在自然殺手細胞或 NK 細胞上表達，XB628 也可能充當腫瘤的 NK 細胞接合劑。正如我們上個月在 AACR 的演講中所展示的那樣，在臨床前模型中，XB628 導致腫瘤細胞和 NK 細胞共定位，從而導致腫瘤細胞殺滅效果顯著高於分別針對 NKG2A 和 PD-L1 的兩種單株抗體組合所觀察到的效果。

As a first-in-class molecule with an innovative mechanism of action, XB628 has created a lot of excitement with the principal investigators of the Phase I trial, so we're looking forward to efficient execution of this study.

作為具有創新作用機制的首創分子，XB628 引起了 I 期試驗主要研究人員的極大興奮，因此我們期待這項研究能夠有效執行。

The second IND we expect to file this year is for XB371, our tissue factor targeting ADC that carries a topoisomerase inhibitor payload. Our presentation last month at AACR showed some very compelling preclinical data demonstrating deep and durable regression 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. Our IND-enabling activities for XB371 will wrap up soon, and we expect to file the IND and initiate the Phase I study later this year.

我們預計今年提交的第二個 IND 是 XB371，這是我們的組織因子靶向 ADC，攜帶拓撲異構酶抑制劑有效載荷。我們上個月在 AACR 上的報告展示了一些非常令人信服的臨床前數據，證明小鼠在單劑量 XB371 後，人類結直腸、肺和胰腺異種移植腫瘤出現深度和持久的消退，凸顯了這種分子在滿足未滿足需求方面的巨大潛力。我們針對 XB371 的 IND 支援活動即將結束，我們預計將在今年稍後提交 IND 並啟動 I 期研究。

The third IND we expect to file this year will be for XB064, our monoclonal antibody that targets ILT2. Our IND-enabling activities for XB064 are progressing on schedule to support filing an IND later this year. In terms of new development candidates, we have some exciting new programs progressing toward DC nomination, 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 we're planning for later this year.

我們預計今年提交的第三個 IND 是針對 XB064 的，這是我們針對 ILT2 的單株抗體。我們針對 XB064 的 IND 支援活動正在按計劃進行，以支持今年稍後提交 IND。在新的開發候選藥物方面，我們有一些令人興奮的新項目正在向 DC 提名邁進，其中包括一些創新的小分子和抗體藥物偶聯物，我期待著在今年晚些時候我們計劃舉行的研發日活動上分享有關這些項目的更多細節。

And finally, we've decided to discontinue the development program for XL495. Following enrollment in several cohorts in the dose escalation phase of the Phase I study, we encountered drug-related toxicities, which we believe are due to on-target off-tumor effects of the drug inhibiting PKMYT1 in normal tissues, a clear signal to us that the therapeutic index is too low to support further development of the compound.

最後，我們決定停止 XL495 的開發計畫。在第一階段研究的劑量遞增階段招募幾個隊列之後，我們遇到了與藥物相關的毒性，我們認為這是由於藥物抑制正常組織中的 PKMYT1 的靶向腫瘤外效應引起的，這向我們發出了一個明確的信號，即治療指數太低，無法支持該化合物的進一步開發。

We're in a high attrition business, and this decision enables us to refocus our resources on advancing our next wave of promising development candidates into and through clinical studies. And with that, I'll turn the call back over to Mike.

我們處於一個人員流失率很高的行業，這項決定使我們能夠重新集中資源，推動下一波有前景的候選藥物進入臨床研究階段。說完這些，我將把電話轉回給麥克。

All right. Thanks, Dana. I'll wrap up here by thanking the entire Exelixis team for our strong start in the first quarter of 2025. And I want to commend everyone for their individual and collective urgency and resilience as we advance our discovery development and commercial priorities. 2025 is already shaping up to be another important year for the business and the patients we hope to serve, now or in the future.

好的。謝謝，達娜。最後，我要感謝整個 Exelixis 團隊為我們在 2025 年第一季取得的良好開端。在我們推進發現發展和商業優先事項的過程中，我要讚揚每個人的個人和集體的緊迫感和韌性。 2025 年對於我們現在或將來的業務和希望服務的患者來說，將成為另一個重要的一年。

We're never satisfied our content with the status quo, and we look to make every hour count as we 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. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

我們從不滿足於現狀，我們希望讓每一小時都充滿意義，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。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) Mike Schmidt, Guggenheim.

（操作員指示）古根漢美術館的麥克·施密特。

Congrats on the great first quarter results here. So 1Q sales were obviously very strong in terms of growth over last year. Could you just help us understand a little bit better what's been driving capital growth at this point? And obviously, neuroendocrine was approved at the end of 1Q. Did you see some contribution from that prior to approval already?

恭喜第一季取得的優異成績。因此，第一季的銷售額與去年同期相比成長顯然非常強勁。您能否幫助我們更理解目前推動資本成長的因素？顯然，神經內分泌藥物在第一季末獲得了批准。在批准之前您是否已經看到了一些貢獻？

And secondly, could you just provide some more color about the launch in neuroendocrine tumors and sort of expectations for the early trajectory there throughout the rest of the year?

其次，您能否提供一些有關神經內分泌腫瘤研發的更多信息，以及對今年剩餘時間內該領域早期發展軌蹟的預期？

All right. Thanks, Michael. P.J., why don't you start? And then Chris and I can provide some color commentary afterwards as needed. Go ahead.

好的。謝謝，麥可。P.J.，為什麼不開始呢？然後，克里斯和我可以根據需要提供一些彩色評論。前進。

Okay. Thanks for the question, Michael. Yes, as you mentioned, we had a strong quarter of results. We're very pleased with the progress we've made. As you look at the business in terms of demand in TRx, we grew significantly in terms of market share from 40% to 44%. And on an absolute level, the volume grew 18% year over year.

好的。謝謝你的提問，麥可。是的，正如您所說，我們本季的業績表現強勁。我們對所取得的進展感到非常高興。從 TRx 的需求角度來看，我們的市佔率顯著成長，從 40% 成長至 44%。從絕對水準來看，銷量較去年同期成長了18%。

Similarly, NRx, we grew share from 38% to 43% in terms of new prescription share in our TKI market basket and even had a more substantial growth on absolute terms of 27%. And both of those, we're the only product to grow share, so we're performing really well relative to the competition.

同樣，就 NRx 而言，我們在 TKI 市場籃子中的新處方份額從 38% 增長到 43%，絕對值甚至實現了 27% 的更大幅度增長。而且，我們是唯一市場佔有率成長的產品，因此與競爭對手相比，我們的表現非常出色。

In terms of our business, the majority of this is being driven by RCC, and in particular, frontline RCC in terms of the combination of cabo/nivo. As I mentioned in my prepared remarks, we had updated data presented at GU ASCO in terms of CheckMate -9ER and the 5-year follow-up data - that's been resonating really well with physicians and really continues to position us in a way that differentiates us from the competition, which we're pleased with.

就我們的業務而言，其中大部分是由 RCC 推動的，特別是 cabo/nivo 組合的前線 RCC。正如我在準備好的演講中提到的那樣，我們已經在 GU ASCO 上展示了 CheckMate -9ER 和 5 年隨訪數據的最新數據 - 這些數據得到了醫生的一致好評，並且確實繼續使我們在競爭中脫穎而出，我們對此感到滿意。

Now a little bit in terms of NET, what I'll say is that we only promote on label. There was a little bit of NET utilization we saw prior to approval. But as I mentioned, the approvals came on March 26th, so very early days in terms of the launch. But what I can tell you is that the feedback we're getting is really positive from prescribers. The team was literally sprinting out of the gate across all tactics and really all channels. So we're really pleased with the momentum there in NET.

現在就 NET 而言，我想說的是，我們只在標籤上進行推廣。在批准之前，我們看到了一點點 NET 使用率。但正如我所提到的，批准是在 3 月 26 日獲得的，因此對於發布而言還處於非常早期的階段。但我可以告訴你的是，我們從處方者那裡得到的回饋非常積極。該團隊實際上正在利用所有策略和所有管道全力衝刺。因此，我們對 NET 的發展勢頭感到非常滿意。

And we think, as I mentioned, it's a really substantial opportunity but obviously, really early days here, and we'll be excited to continue to report updates on that as the launch progresses and we get throughout the year.

正如我所提到的，我們認為這是一個非常重要的機會，但顯然，現在還處於早期階段，隨著發布的進展以及全年的進展，我們將很高興繼續報告有關這方面的最新消息。

Asthika Goonewardene, Truist.

Asthika Goonewardene，Truist。

I'll echo the congratulations on some pretty rockstar outperformance in Q1 here and the guidance raise. I want to add on to Michael's question, just to get a little bit more of the dynamics on the NET launch. Did you guys see a bolus effect? Or do you guys anticipate a bolus effect here in the early days of launch at NET? And if so, when do you kind of expect it to kind of stabilize to give you a more accurate run rate in terms of acceleration and uptake?

我要再次祝賀第一季的一些出色表現以及指導價的提升。我想補充一下邁克爾的問題，以便進一步了解 NET 發布的動態。你們看到了推注效應嗎？或者你們是否預期在 NET 發布初期就會出現推注效應？如果是這樣，您預計它什麼時候能夠穩定下來，從而為您提供更準確的加速度和吸收率運行率？

And then second, if I may, when you modified the statistical analysis for STELLAR-303 to do it instead of doing sequentially from non-liver met to ITT and do it more as a dual primary end point for both those groups, does that help in any way with the alpha spend or maybe the hazard ratio you need to meet statistical significance?

其次，如果可以的話，當您修改了 STELLAR-303 的統計分析方法，不再按從非肝轉移至 ITT 的順序進行，而是將其作為這兩組的雙重主要終點時，這對滿足統計顯著性所需的 alpha 花費或風險比有任何幫助嗎？

All right. Thanks, Asthika. P.J. will click on that next, and then we'll go over Amy for 303.

好的。謝謝，Asthika。P.J. 接下來會點擊它，然後我們會點擊 303 的 Amy。

Yes. Thanks for the question, Asthika. What I'll say is, obviously, very early days in the NET launch. As I mentioned, we're very excited about it. We'll continue to see the trends as we move forward. I mean these patients are advanced in their disease with neuroendocrine tumors, so we're necessarily expecting to see a bolus there. As I mentioned, great prescriber excitement about the drug. We're seeing new prescriptions out of the gate and just looking forward to tracking that going forward.

是的。謝謝你的提問，Asthika。我想說的是，顯然，NET 發布還處於早期階段。正如我所提到的，我們對此感到非常興奮。隨著我們不斷前進，我們將繼續觀察這些趨勢。我的意思是，這些患者的神經內分泌腫瘤已經到了晚期，所以我們必然希望看到推注。正如我所提到的，處方者對這種藥物感到非常興奮。我們正在看到新的處方，並期待未來能夠繼續追蹤。

Amy?

艾米？

Sure. Thanks, Asthik. So just quickly, with regard to changing the endpoint, just to reset for a second. STELLAR-303 is a very large global clinical Phase III pivotal study. And the trial is designed to allow us to assess outcomes in the population of patients without liver mets referred to as NLM and in the ITT population.

當然。謝謝，Asthik。因此，關於改變端點，只需快速重置一秒鐘。STELLAR-303 是一項非常大型的全球臨床 III 期關鍵研究。該試驗的目的是讓我們評估無肝轉移患者群體（稱為 NLM）和 ITT 族群的治療結果。

As you know, we completed enrollment about a year ago, and Mike has said many times, we're in the business of generating p-values and positive outcomes for patients, and we continuously evaluate our studies and make modifications necessary to ensure we achieve the maximum success for those patients.

如您所知，我們大約一年前完成了招募，麥克曾多次表示，我們的工作是為患者創造 p 值和積極結果，我們不斷評估我們的研究並做出必要的修改，以確保為這些患者取得最大的成功。

So given that we completed enrollment about a year ago, and the relative maturity of events in the liver met population really suggested to us that it's best to move the ITT analysis from sequential to dual because the really significant potential value as a positive outcome would help a much larger patient population. So it really wasn't about p-values or hazard ratios or alpha.

因此，考慮到我們大約一年前就完成了招募，並且肝臟轉移人群中事件的相對成熟度確實向我們表明，最好將 ITT 分析從順序分析轉變為雙重分析，因為作為積極結果的真正重要的潛在價值將有助於更大的患者群體。所以這其實與 p 值、風險比或 alpha 無關。

(Operator Instructions) Sean Laaman, Morgan Stanley.

（操作員指示） 摩根士丹利的 Sean Laaman。

Good afternoon Mike and team, great set of results. Can you maybe just sort of contextualize what seasonality we can expect for cabo for the year? I think the beat on street was around $50 million on revenue and the raise is about $100 million on revenue. Maybe just give us some context around that, please.

下午好，麥克和團隊，取得了很好的成果。能否簡單介紹一下今年卡波的季節性變化？我認為華爾街的預期收入約為 5,000 萬美元，而融資收入約為 1 億美元。請給我們一些有關該問題的背景資訊。

Sure. Chris, do you want to start with that, and I'll provide color commentary?

當然。克里斯，你想從這個開始嗎，然後我會提供詳細的評論？

Okay. Thanks, Sean. So I mean the seasonality, I think that we've seen in the past where we saw higher gross-to-net in the first quarter and lower gross-to-net progressing throughout the year is gone because of our specified small manufacturer designation. So the 1% is across all Medicare patients throughout the year. So that creates some stability in the gross-to-net.

好的。謝謝，肖恩。所以我的意思是季節性，我認為我們過去看到過，第一季的毛利與淨利之比較高，而全年的毛利與淨利之比較低，但由於我們指定的小型製造商名稱，這種季節性已經消失。因此，這 1% 涵蓋了全年所有的醫療保險患者。這樣就為總額與淨額的比率創造了一定的穩定性。

We're still projecting gross-to-net to be in the 29% to 30% range like I talked about last quarter. And this year, we also didn't have an inventory dynamic like we've had in past years where we had higher inventory coming in Q4 and lower and the destocking in Q1, so we didn't see that either. So from a gross-to-net perspective, we see some stability there in that 29% to 30% range, and we didn't have the inventory dynamics that we've seen in the past.

我們仍然預計毛利率將在 29% 至 30% 之間，就像我上個季度談到的那樣。今年，我們也沒有像過去幾年那樣出現庫存動態，第四季度庫存較高，而第一季庫存較低且去庫存，所以我們也沒有看到這種情況。因此，從總額與淨額的角度來看，我們看到 29% 到 30% 的範圍內有一定的穩定性，而且我們沒有看到過去看到的庫存動態。

Gregory Renza, RBC.

格雷戈里·倫扎（Gregory Renza），RBC。

Just a quick question on the full year 25 guidance. Could you confirm the $100 million increase in terms of where does that come from, and how much of the contribution of that amount come from NET? And related question, when do you anticipate having a clarity on the potential of NET included into the full year 25 guidance?

關於全年 25 年指導，我只想問一個簡單的問題。您能否確認這 1 億美元的增額來自哪裡，以及其中有多少貢獻來自 NET？相關問題是，您預計何時能夠明確 NET 的潛力並將其納入全年 25 年指導中？

Thanks for the question. Yes, just talking about the guidance raise, I think it's safe to say the biggest part of that is in the RCC-based business. It's a little bit of NET in there, but the majority of it is based on the strength of the base business in the first quarter. We're tracking NET very closely, obviously, as well as for the whole business because that's what we do.

謝謝你的提問。是的，僅談論指導性提升，我認為可以肯定地說，其中最大的一部分是基於 RCC 的業務。這其中有一點淨額，但大部分是基於第一季基礎業務的實力。顯然，我們正在密切關注 NET 以及整個業務，因為這就是我們的工作。

And as we feel like we've got momentum there, certainly coming out of the launch and great performance so far. So I don't want to give you guidance, I'm giving you a different guidance later, but we're tracking that closely. And when we think it's the right time with the right level of confidence, we will talk about that in the future.

我們感覺我們已經有了動力，從發佈到現在，表現都非常出色。所以我不想給你指導，我稍後會給你不同的指導，但我們會密切跟踪。當我們認為時機成熟、信心充足時，我們會在未來討論這個問題。

Silvan Tuerkcan, Citizens.

Silvan Tuerkcan，公民。

Congrats on this stellar quarter. I just wanted to ask a more general question on your BD appetite. Can you just maybe talk about, specifically, the scenario for Exelixis, and maybe by extrapolation to some of your peers, how does the current environment influence your BD plans? Are you currently on hold? Are you looking? Are there certain roadblocks that need to get away for you to pull the trigger here?

恭喜本季取得輝煌成績。我只是想問一個關於你對 BD 的胃口的更一般性的問題。能否具體談談 Exelixis 的情況？並且透過對您的一些同行進行推斷，當前的環境如何影響您的 BD 計劃？您目前處於等待狀態嗎？你在看嗎？您是否需要清除某些障礙物才能扣下板機？

Yes. Thanks for the question. As I said in my prepared remarks, we are definitely open for business on the BD side. We're focused on high-conviction assets that fit into our franchise framework within GU and GI oncology, where we believe we have the opportunity to convert differentiating clinical data into commercial success. That's the cabo story, that's the lens with which we look at all opportunities internally and externally.

是的。謝謝你的提問。正如我在準備好的發言中所說的那樣，我們絕對願意開展 BD 方面的業務。我們專注於符合我們在泌尿外科和胃腸道腫瘤領域的特許經營框架的高信念資產，我們相信我們有機會將差異化臨床數據轉化為商業成功。這就是卡波的故事，這就是我們看待所有內部和外部機會的視角。

So that quite frankly, is the same, hasn't changed and will continue to be the same going forward. We're not looking to buy on the cheap, right? We're not looking to buy assets that we see as being very risky, but they're cheap, so it might make sense. That's not how we look at it. We're a high science. We want to make sure we can move the needle for patients. And the dynamic that we've observed and learned and been able to be successful with with cabo is that if you can move the needle for patients, if you can improve standard of care, you can commercialize that asset very, very productively. So that's the goal.

坦白說，這一點是一樣的，沒有改變，而且今後仍將如此。我們並不是想貪便宜，對吧？我們並不打算購買我們認為風險很高的資產，但它們很便宜，所以這可能是有意義的。我們的看法並非如此。我們是一門高等科學。我們希望確保能夠為患者帶來幫助。我們觀察、學習到並能夠在 cabo 上取得成功的動態是，如果你可以為患者帶來改變，如果你可以提高護理標準，那麼你就可以非常、非常有效率地將這項資產商業化。這就是目標。

So as I've said on previous calls, we've burned many haystacks, we've got a few needles that we're looking at right now. We're hoping to transact, maybe we do, maybe we don't. It's all about the right assets at the right time, at the right valuation. But we've got a great team across the BD and financial sectors within legal, within commercial, within discovery and development.

正如我在之前的電話中所說的那樣，我們已經燒掉了很多乾草堆，現在我們只看到了幾根針。我們希望進行交易，也許可以，也許不行。一切都取決於在正確的時間以正確的估值獲得正確的資產。但我們在 BD 和金融領域擁有一支優秀的團隊，涉及法律、商業、發現和開發等領域。

So we've got a full court press here to be able to figure out makes the most sense for us and then really how to do that in a practical way that can build value for patients and for shareholders.

因此，我們採取了全力以赴的措施，以便找到對我們來說最有意義的方法，並真正以切實可行的方式做到這一點，從而為患者和股東創造價值。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great, congratulations again. It's really a terrific showing. So I have maybe two interrelated questions. One is just a little housekeeping, if you can just remind us, Part D redesign - how much of an impact did you have this quarter, if any? And what percentage of your business is Medicare-facing versus commercial?

太好了，再次恭喜。這真是一場精彩的表演。所以我可能有兩個相互關聯的問題。一個只是一點家務，如果你能提醒我們，D 部分重新設計 - 你對本季度有多大影響，如果有的話？您的業務中，醫療保險和商業的比例是多少？

And then sort of the more meaty question is: clearly, Mike, it sounds like you're waiting for the uptick in NET, and you're saying it's a $1 billion opportunity. How much of that $1 billion is sort of first-line versus second- or third-line for small molecules? I mean it sounds like you're aiming, and you're intending, and you should probably raise guidance again.

然後更重要的問題是：顯然，麥克，這聽起來像是你在等待 NET 的上升，而你說這是一個價值 10 億美元的機會。這 10 億美元中有多少是用於小分子的第一線治療，多少是二線或三線治療？我的意思是，這聽起來像是你的目標，你的意圖，你可能應該再提出指導。

Yes. So Chris, why don't you take care of the housekeeping, and then P.J. can address some of the kind of overall market dynamics for NET as we see it currently? Go ahead, Chris.

是的。那麼克里斯，你為什麼不處理一些日常事務，然後 P.J. 可以解決我們目前看到的 NET 整體市場動態的一些問題呢？繼續吧，克里斯。

Yaron, it's Chris. So from a Medicare Part D redesign perspective, if you look at a quarter -- Q4 versus Q1, we didn't see a big dynamic there, big change in the amount of Medicare reimbursements we had to make. If you look at it versus Q1 last year, there's a bigger difference there. We had some benefit towards us in Q1 this year.

亞龍，我是克里斯。因此，從醫療保險 D 部分重新設計的角度來看，如果你看一下一個季度——第四季度與第一季相比，我們並沒有看到很大的變化，我們必須支付的醫療保險報銷金額也沒有很大的變化。如果與去年第一季相比，差異更大。今年第一季我們獲得了一些利益。

Now from a split between commercial business and Medicare Part D business, it's about equal when you look at the two compared to another from a patient and payer mix perspective.

現在，從商業業務和醫療保險 D 部分業務的劃分來看，從患者和付款人組合的角度來看，兩者之間的差異大致相等。

And as far as NET goes, like I mentioned, we view this as a substantial opportunity. The $1 billion is across all lines of therapy. That said, in terms of second- and third-line, that is where small molecules make up the majority of utilization, and we think there's substantial opportunity there.

就 NET 而言，正如我所提到的，我們認為這是一個巨大的機會。這 10 億美元將用於所有治療領域。也就是說，就二線和三線而言，小分子佔據了大部分的利用率，我們認為那裡有很大的機會。

Even looking at another therapy in the market, for example, if you look at Lutathera's recent revenue, if you look at their last quarter's revenue, given it a run rate, that's $560 million annualized. So again, we're very excited by this opportunity. When it comes to the small molecule market, we're the only branded molecule out there with a substantial and experienced team behind this, and we're really excited about the ability to help patients and move the business forward.

即使看看市場上的另一種療法，例如，如果你看看 Lutathera 最近的收入，如果你看看他們上個季度的收入，給出它的運行率，那就是年化 5.6 億美元。因此，我們對這個機會感到非常興奮。在小分子市場，我們是唯一擁有大量經驗豐富的團隊的品牌分子，我們對能夠幫助患者並推動業務發展感到非常興奮。

Chi Fong, Bank of America Securities.

方志，美銀證券。

One question on capital allocation. Mike, I've asked you this question early in the year before, and I'm going to ask you again. I'm curious about your philosophy in terms of the buyback program. Obviously, you guys have been consistently buying back since 2023. I think, roughly high single-digit percentage of outstanding shares if I can correctly, I think annual, maybe like $500 million at least, give or take.

關於資本配置的一個問題。麥克，我去年年初就問過你這個問題，現在我還要再問你一次。我對您的回購計劃的理念很好奇。顯然，自 2023 年以來，你們一直持續回購。我認為，如果我沒記錯的話，流通股的百分比大約在個位數左右，每年大概至少在 5 億美元左右。

So I'm just curious, if share price remain current in existing level or even if cabo sales increase, what's your philosophy on share buyback versus reinvesting capital into R&D or business development?

所以我只是好奇，如果股價保持在現有水平，或者即使 cabo 銷售額增加，您對股票回購的看法是什麼，還是將資本再投資於研發或業務發展？

Thank you for the question. Look, again, as we talked about previously , and I reiterated in prepared remarks today, with our balance sheet and expected free cash flows, we think we can allocate capital effectively around investing in the internal pipeline, doing the appropriate thoughtful and pragmatic BD, and still buying back shares when we think the shares are undervalued relative to where we think it can go. So I think that's the right approach.

謝謝你的提問。再說一遍，正如我們之前談到的，而且我在今天的準備好的發言中也重申了這一點，根據我們的資產負債表和預期的自由現金流，我們認為我們可以有效地分配資本，用於投資內部渠道，進行適當、深思熟慮和務實的業務拓展，並且在我們認為股價相對於我們認為的可能價格水平被低估時仍可回購股票。所以我認為這是正確的方法。

How we do that, how we emphasize one over the other will be situationally dependent. I think by my math, we bought back about 19% or 20% of our outstanding float over the last couple of years. We've done that at significantly lower prices than where the stock is trading at today. So that's a good move from an investment point of view. We like investing in ourselves, right?

我們如何做到這一點，如何強調其中一個，將取決於具體情況。根據我的計算，我們在過去幾年裡回購了約 19% 或 20% 的流通股。我們以比目前股票交易價格低得多的價格完成了這筆交易。從投資角度來看，這是一個很好的舉措。我們喜歡投資自己，對嗎？

Again, in the context of how we view quality, how we view assets that can move the needle for patients and shareholders, we think Exelixis is a great place to put that money. So that's how we're going to continue to operate. We're data dependent. We're data driven. So we'll see how that goes in the future. But again, having the cash flows that we've got and the balance sheet that we have gives us the ultimate optionality ,and we like that going forward.

再次，從我們如何看待品質、如何看待能夠為患者和股東帶來積極影響的資產的角度來看，我們認為 Exelixis 是投資這筆資金的最佳選擇。這就是我們將繼續運作的方式。我們依賴數據。我們以數據為驅動。因此我們將拭目以待未來情況會如何發展。但是，我們擁有的現金流量和資產負債表為我們提供了最終的選擇權，我們希望未來能夠繼續保持這種狀態。

Akash Tewari, Jefferies.

Akash Tewari，傑富瑞。

It sounds like you're going to have a go-no-go decision on your head and neck study with Merck at the end of the year. What do you want to see on event rates to justify moving forward with that trial? And then also, when we think about the PD-1 VEGF bispecific class, there's a lot of similarities to kind of the pitch on zanza. You hit VEGF, but you have a wider therapeutic window. Have you thought about acquiring one of those assets for RCC and head neck given your partner, Merck already has the LaNova assets?

聽起來你將在今年年底就與默克合作的頭頸部研究做出是否進行的決定。您希望看到什麼樣的事件發生率來證明繼續進行該試驗是合理的？而且，當我們考慮 PD-1 VEGF 雙特異性類時，它與 zanza 上的宣傳有許多相似之處。你擊中了 VEGF，但你擁有更廣闊的治療窗口。鑑於您的合作夥伴默克公司已經擁有 LaNova 資產，您是否考慮過收購 RCC 和頭頸科資產？

Okay. So why don't you, Amy, take the head and neck question, and I'll come back on the BD cycle?

好的。那麼，艾米，為什麼不先回答頭部和頸部的問題，然後我再回來討論 BD 週期呢？

Okay. Yes. Thanks, Akash, for the question. So I did mention in the prepared remarks that we are anticipating to have sufficient number of events in order for the IDMC to review and enable a go-no-go to Phase III. We don't typically talk about what those events are. And so I'm just waiting for the data to mature so that we can have the call and get the decision, but that's really all I can say.

好的。是的。謝謝 Akash 提出這個問題。因此，我在準備好的發言中確實提到，我們預計將有足夠數量的活動，以便 IDMC 進行審查並決定是否進入第三階段。我們通常不會談論這些事件是什麼。所以我只是在等待數據成熟，以便我們能夠做出決定，但這真的是我所能說的全部。

Okay. Thank you. Yes, on the BD side, look, we look at everything with a pretty careful eye. We really like being in the bispecific space and certainly 628 is a good example of that, that we think the potential combination with zanza gives us really good coverage on the PD-L1 side, on the VEGF side and then bringing in NK cells as well.

好的。謝謝。是的，在 BD 方面，看，我們用非常仔細的眼光看待一切。我們非常喜歡雙特異性領域，當然 628 就是一個很好的例子，我們認為與 zanza 的潛在組合可以讓我們在 PD-L1 方面、VEGF 方面以及引入 NK 細胞方面獲得很好的覆蓋。

So how you slice and dice those opportunities, you have to be really thoughtful and really careful. Obviously, there's a lot of PD-L1 VEGF targeting bispecifics right now. We don't see a line of differentiation in that area. And certainly, there's key data waiting to be disclosed around certainly, say, the survival data in the non-small cell lung cancer trials. So we're looking at everything. We consider everything. Again, we have a, I think, unique perspective on how to build value, and we'll continue to execute on that as we go forward.

因此，如何細分這些機會，你必須非常深思熟慮並且非常小心。顯然，目前有許多針對 PD-L1 VEGF 的雙特異性抗體。我們沒有看到該領域的任何區別。當然，還有一些關鍵數據有待揭露，例如非小細胞肺癌試驗的存活數據。所以我們正在觀察一切。我們考慮一切。再說一次，我認為我們對如何創造價值有著獨特的見解，並且我們將在未來繼續執行這一點。

Derek Archila, Wells Fargo.

德里克·阿奇拉，富國銀行。

Congrats on the quarter. A quick one from us. Can you help set expectations a bit on the non-clear cell renal cell carcinoma study? And what have we seen here in this patient population?

恭喜本季取得佳績。我們快速說一下。您能否協助設定一些對非透明細胞腎細胞癌研究的期望？那麼我們在這個患者群體中看到了什麼呢？

Amy, do you want to take that?

艾米，你想拿走那個嗎？

Yes, sure. So with regard to setting expectations, this is, I think, a very exciting study for us. One, it is a study in kidney cancer. It's the first Phase III that's ever been run in the smaller population in kidney cancer. And so having a positive outcome, we think would really benefit patients who have been otherwise lumped into the category of clear cell kidney cancer. The best benchmark that we have is probably with sunitinib. That's what we're going up again.

是的，當然。因此，就設定期望而言，我認為這對我們來說是一項非常令人興奮的研究。一、這是一項關於腎癌的研究。這是首次在較小族群腎癌患者中進行的 III 期臨床試驗。因此，我們認為，獲得積極的結果將真正使那些原本被歸類在透明細胞腎癌類別的患者中受益。我們擁有的最佳基準可能是舒尼替尼。這就是我們再次上升的原因。

So this is a study that is looking at nivolumab plus zanzalintinib versus sunitinib. We know that cabo has beaten sunitinib in a head-to-head, cabo/nivo beat sunitinib, and we think that zanza is better than cabo. And so cabo/nivo against sunitinib, we think, has a very high probability of success here. The PFS that is most commonly quoted for sunitinib and non-clear cell space is about five to six months.

這是一項比較 nivolumab 加 zanzalintinib 與舒尼替尼療效的研究。我們知道 cabo 在正面交鋒中擊敗了舒尼替尼，cabo/nivo 擊敗了舒尼替尼，我們認為 zanza 比 cabo 更好。因此，我們認為 cabo/nivo 對抗舒尼替尼的成功機率非常高。舒尼替尼和非透明細胞空間最常被引用的 PFS 約為五到六個月。

Andy Hsieh, William Blair.

安迪謝、威廉布萊爾。

Congratulations on the beat and raise. Two quick ones for us. Just going back to the 303 statistical analysis change, I'm curious about the definition. So dual versus co-primary endpoints, can you declare victory with this win in either end point? So that's part one.

恭喜擊敗並加薪。對我們來說，有兩個簡短的問題。剛剛回到 303 統計分析變化，我對定義很好奇。那麼雙重與共同主​​要終點，您是否可以透過任一終點的勝利來宣布勝利？這是第一部分。

Part two, so the alpha spend, so do you need .025 for success on just 1 of the 2 endpoints, if that's the scenario? And I was captivated by Dana's commentary about the induced proximity mechanism for 628. I saw several of the presentations looking at kind of dual bispecific ADCs and dual payloads. Curious about your thoughts on expanding on your tool kits to explore that opportunity.

第二部分，即 alpha 支出，如果是這種情況，您是否需要 0.025 才能在兩個端點中的其中一個端點上取得成功？我被達娜關於 628 誘導接近機制的評論深深吸引。我看了幾種有關雙特異性 ADC 和雙有效載荷的演示。我很好奇您對擴展工具包以探索這一機會的想法。

Thanks, Andy. We've addressed the 303 question several times. So let's start with Dana on the 628 and the kind of strategy there, and then we'll go to Amy real fast for a wrap-up on 303.

謝謝，安迪。我們已多次討論 303 問題。因此，讓我們先從 Dana 談談 628 及其策略，然後我們將快速轉到 Amy 來總結 303。

Sure. So just to reiterate, the XB628 presentation at AACR was our first sort of data dump on that compound at a scientific conference, and we showed quite a few data points, but I think that the key one that you're referencing, Andy, is the one showing the ability of the molecule to colocalize NK cells with tumor cells. And then critically, that translated to a much higher sort of level of NK-mediated cytotoxicity against those tumor cells in an in vitro assay compared to monospecific antibodies hitting each checkpoint individually.

當然。因此，再次重申一下，在 AACR 上展示的 XB628 是我們在科學會議上首次展示有關該化合物的數據，我們展示了相當多的數據點，但我認為，安迪，你所引用的關鍵數據點是展示該分子將 NK 細胞與腫瘤細胞共定位的能力。至關重要的是，與單獨攻擊每個檢查點的單特異性抗體相比，這在體外試驗中轉化為針對這些腫瘤細胞的 NK 介導的細胞毒性水平更高。

So yes, I mean, obviously, we're very excited about this molecule based on its ability to potentially impact or address unmet need across all of our key therapeutic areas, including GU and GI oncology and in colorectal cancer in combination with drugs like zanzalintinib and other drugs.

所以是的，我的意思是，顯然，我們對這種分子感到非常興奮，因為它有可能影響或解決我們所有關鍵治療領域未滿足的需求，包括泌尿生殖系統和胃腸道腫瘤學以及結直腸癌與讚扎林替尼等藥物聯合使用。

When it comes to other types of technologies that you kind of hinted at in terms of multi payloads and things like that, we're, of course, very interested in those types of technologies. And what I would just say at this point is stay tuned for more information that we plan to kind of bring out from behind the curtain at the R&D Day event later this year where we're planning to really go into a lot more of our strategy for the future of our discovery pipeline.

當談到您暗示的多有效載荷等其他類型的技術時，我們當然對這些類型的技術非常感興趣。我現在想說的是，請繼續關注我們計劃在今年晚些時候的研發日活動上揭曉的更多信息，我們計劃在活動中深入探討我們未來發現渠道的更多戰略。

Yes, just real quickly. So you are right, Andy, in that co-primary requires both be positive in order for the study to be positive. Dual primary means either one can be positive for the study to be positive. However, it does not necessitate equal split of alpha.

是的，非常快。所以你是對的，安迪，共同主要要求雙方都積極，研究才會積極。雙重主要意味著，只要有一個為陽性，研究結果就會為陽性。然而，它並不需要平等地分配 alpha。

Andrew Berens, Leerink Partners.

安德魯貝倫斯，Leerink Partners。

This is Eason on for Andy. Congrats on the quarter. Just two quick ones. On 303, can you remind us what zanza/atezo has demonstrated in the ITT? And how do you expect the control arm to perform? And then maybe on 304, will we get an interim OS as part of the second half update? And just curious, do you anticipate needing OS data in order to file?

這是 Eason 代替 Andy 的表演。恭喜本季取得佳績。只需簡單兩句話。關於 303，您能提醒我們 zanza/atezo 在 ITT 中示範了什麼嗎？您預計控制臂的性能如何？那麼也許在 304 上，我們會在下半年更新中獲得一個臨時作業系統嗎？只是好奇，您是否預計需要 OS 資料才能歸檔？

Amy?

艾米？

Yes, sure. So thanks for the question. I'll remind everybody of the data that we presented in STELLAR-001, which was zanza plus atezolizumab in patients with colorectal cancer. The eligibility criteria were pretty similar to that for 303 with the exception that everybody had to be RAS wild-type on STELLAR-001.

是的，當然。感謝您的提問。我要提醒大家我們在 STELLAR-001 中所展示的數據，研究是針對大腸直腸癌患者使用 zanza 和 atezolizumab 合併治療的研究。資格標準與 303 非常相似，但每個人在 STELLAR-001 上都必須是 RAS 野生型。

But there, what we saw was median OS with zanza/atezo of 11.7 months in the ITT population. And it was 18.5 months in the non-liver met patient population. And of course, that study is still ongoing with additional follow-up, and we'll update those as possible.

但是，我們看到 ITT 族群中使用 zanza/atezo 的中位數 OS 為 11.7 個月。在非肝病患者族群中，此時間為 18.5 個月。當然，這項研究仍在進行中，我們會盡可能更新後續內容。

That bodes well when you consider these are cross-trial comparisons. The benchmark of regorafenib that we know from the RCAT database from the Phase III studies and other comparators is really in the ITT patient population somewhere between 6 to 8 months.

當你考慮到這些是交叉試驗比較時，這是一個好兆頭。我們從 RCAT 資料庫的 III 期研究和其他比較中了解到，瑞戈非尼的基準實際上是在 6 至 8 個月之間的 ITT 患者群體中。

Jay Olson, OpCo.

傑伊·奧爾森（OpCo）。

This is Cheng Li on the line for Jay. Congrats on the quarter. Maybe two questions from us. First, going back to the early launch of cabo in NET. I'm wondering if you can maybe describe the characteristics of those early adopters? For example, like the number of prior myotherapy and also their tumor location.

我是程莉，為傑伊接聽電話。恭喜本季取得佳績。也許我們想問兩個問題。首先，回顧一下 cabo 在 NET 上的早期推出。我想知道您是否可以描述一下這些早期採用者的特徵？例如，之前的肌肉治療次數以及腫瘤位置。

And secondly, on 309, I'm wondering if you can provide some color on the data to be presented this year - whether that will include both single agent and also combination data?

其次，關於 309，我想知道您是否可以提供一些今年要呈現的數據 - 是否包括單一藥劑和組合數據？

Yes. P.J., why don't you start with the NET? I'm not sure we can answer that question effectively, but go ahead.

是的。P.J.，為什麼不從 NET 開始呢？我不確定我們能否有效地回答這個問題，但請繼續。

Yes. I mean, I guess what I can say is qualitatively, similar to the data set of CABINET and in the label being very broad, what we're hearing generally is excitement to utilize the drug and utilization in a very broad manner, regardless of sort of tumor location, patient grade line of therapy, et cetera. So I think just a lot of excitement to have a drug that physicians can use kind of broadly across the neuroendocrine tumor space.

是的。我的意思是，我想我可以說的是，從質量上講，類似於 CABINET 的數據集，並且標籤非常廣泛，我們通常聽到的是人們對使用這種藥物感到興奮，並且以非常廣泛的方式使用，無論腫瘤位置、患者的治療等級線等等。因此，我認為，有一種藥物可以在神經內分泌腫瘤領域廣泛使用，這令人非常興奮。

But it's safe to say that in the commercial setting, we don't get a lot of details on the patients that are getting the drug unlike in the trial itself.

但可以肯定地說，在商業環境中，與試驗本身不同，我們無法獲得有關接受該藥物的患者的詳細資訊。

Correct, yes, just qualitative.

正確，是的，只是定性。

Do you want to go fast, Amy?

你想走快一點嗎，艾米？

Yes, sure, Jay. Really excited about XL309. This is our small molecule USP1 inhibitor. We are in both as monotherapy and in combination with PARP inhibition. We will be happy to share the data publicly once we have a complete data set.

是的，當然，傑伊。真的對 XL309 感到興奮。這是我們的小分子 USP1 抑制劑。我們既採用單一療法，也採用與 PARP 抑制聯合療法。一旦我們擁有完整的資料集，我們將很樂意公開分享資料。

Ash Verma, UBS.

瑞銀的 Ash Verma。

I wanted to understand like the NET launch dynamic a little bit. If you can elaborate on where you expect the uptake to come from? Is it from the epNET or the pNET setting? And is there any difference between like this being used before or after SUTUNT? Or how should we think about the competition with lutathera?

我想稍微了解一下 NET 的啟動動態。您能否詳細說明一下您預計這種吸收將來自哪裡？它是來自 epNET 還是 pNET 設定？在 SUTUNT 之前或之後使用有什麼區別嗎？或者說我們應該如何看待與lutathera的競爭？

Yes. Again, I would just say early days in terms of the launch setting and our expectation and what we're kind of hearing from customers is that given the data abroad, and this data set is unique in that sense and utilized across sites of origin, lines of therapy, et cetera. That's what we're hearing, as well as that's the fact that our expectation is that it will be broadly utilized across that, and we're aiming to be the small molecule leader in the space within our indication.

是的。再說一次，我只想說，就發布環境和我們的期望而言，還處於早期階段，我們從客戶那裡聽到的是，鑑於國外的數據，這個數據集在這個意義上是獨一無二的，並且可以在原產地、治療方法等方面使用。這就是我們所聽到的，事實上我們期望它將被廣泛應用於該領域，我們的目標是成為我們適應症領域的小分子領導者。

Peter Lawson, Barclays.

巴克萊銀行的彼得·勞森。

Congratulations on the quarter. Just on the quarter, I don't think you mentioned about clinical trial sales. If you could talk about that? And then how are you going to think about pricing power considering your position in RCC?

恭喜本季。僅就本季度而言，我認為您沒有提到臨床試驗銷售。您能談談這個嗎？那麼考慮到您在 RCC 的地位，您將如何考慮定價權？

Chris, go ahead.

克里斯，說吧。

Yes, Peter. We did talk about clinical trial sales in the prepared remarks section. We had about $12 million in the quarter.

是的，彼得。我們確實在準備好的評論部分討論了臨床試驗銷售。本季我們的營收約為 1200 萬美元。

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

This is Felix on for Sudan Loganathan. Congrats on the quarter. I have a quick question regarding STELLAR-311 in the next indication that will be initiated by first half 2025. Given the approval of cabo for the same indication, how does that change the bank for subset for the STELLAR 3 on NET drop?

這是蘇丹洛加納坦 (Sudan Loganathan) 的菲利克斯 (Felix)。恭喜本季取得佳績。我有一個簡單的問題，關於 STELLAR-311 的下一個適應症，將於 2025 年上半年啟動。鑑於 cabo 對相同適應症的批准，這將如何改變 NET 下降中 STELLAR 3 子集的銀行？

Thanks, Felix. I'll try and answer this quickly. This is a study that is going up against everolimus. This will be zanzalintinib versus everolimus as a first oral therapy in patients who have progressed on their FSA. So it's a slightly different space. All of the KOLs have a global steering committee, and we've been talking globally with thought leaders around really the world. They're all very excited about this option and the trial. So at this point in time, we're not that concerned about competing with cabo.

謝謝，菲利克斯。我會盡快回答這個問題。這是一項針對依維莫司的研究。這將是 zanzalintinib 與依維莫司的首次口服療法，用於治療 FSA 病情進展的患者。所以這是一個稍微不同的空間。所有的關鍵意見領袖都有一個全球指導委員會，我們一直在與世界各地的思想領袖進行交流。他們都對這個選擇和試驗感到非常興奮。因此目前我們並不太擔心與 cabo 的競爭。

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. I would now like to turn the call back over to your host, Ms. Susan Hubbard.

謝謝。女士們、先生們，隊列中沒有其他問題了。現在我想將電話轉回給主持人蘇珊·哈伯德女士。

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

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，我們當然歡迎您來電諮詢。

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。