Exelixis Inc (EXEL) 2024 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Exelixis third-quarter 2024 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，美好的一天，歡迎參加 Exelixis 2024 年第三季財務業績電話會議。我叫托旺達 (Towanda)，今天我將擔任您的接線生。謹此提醒，本次通話將會被錄音以供重播。

I would now like to turn the call over to your host for today, Mr. Varant Shirvanian, Director of Investor Relations. Please proceed.

現在我想將電話轉給今天的東道主投資者關係總監 Varant Shirvanian 先生。請繼續。

Thank you, Towanda, and thank you all for joining us for the Exelixis third-quarter 2024 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; and PJ Haley, our Executive Vice President of Commercial who together will review our progress for the third-quarter 2024 ended September 30, 2024.

謝謝 Towanda，也謝謝大家參加 Exelixis 2024 年第三季財務業績電話會議。參加今天的電話會議的是我們的總裁兼執行長 Mike Morrissey； Chris Senner，我們的財務長；我們的商務執行副總裁 PJ Haley 將共同審查我們截至 2024 年 9 月 30 日的 2024 年第三季的進展。

Amy Peterson, our Chief Medical Officer; and Dana Aftab, our Chief Scientific Officer, are also on the call today and will participate in our question-and-answer session. 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 was 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.

Amy Peterson，我們的首席醫療官；我們的首席科學官 Dana Aftab 今天也參加了電話會議，並將參加我們的問答環節。在今天的電話會議中，我們將提及並非根據公認會計原則計算的財務指標。請參閱今天發佈在我們網站上的新聞稿，了解我們使用此類非 GAAP 衡量標準的原因以及從我們的 GAAP 結果得出這些衡量標準的表格。

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 estimates and projections from our annual US net product revenues and potential marketing growth opportunities. These estimates and projections involve a number of assumptions and limitations, and we caution investors not to place undue reliance on this information.

在本演示過程中，我們將對未來事件和公司未來業績做出前瞻性陳述。這包括有關發現、產品開發、監管、商業、財務和策略事項的可能發展的聲明，以及我們對美國年度淨產品收入和潛在行銷成長機會的估計和預測。這些估計和預測涉及許多假設和限制，我們提醒投資者不要過度依賴這些資訊。

Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which are 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.

當然，實際事件或結果可能存在重大差異。我們建議您參閱我們不時向美國證券交易委員會提交的文件，這些文件的標題為“風險因素”，指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、產品開發相關的成本水平相關的風險和不確定性、業務開發和商業化活動。

With that, I'll turn it over to Mike.

有了這個，我會把它交給麥克。

All right. Thanks, Varant, and thanks to everyone for joining us on the call today. We'll use our prepared remarks today to provide a strategic perspective on the business with a forward-looking view of the opportunities for cabozantinib, zanzalintinib, and the early-stage pipeline to maximize success in building a multi-franchise oncology business.

好的。謝謝 Varant，也謝謝大家今天加入我們的電話會議。我們將利用今天準備好的發言稿，對卡博替尼、贊扎林替尼和早期管道的機會提供前瞻性的業務戰略視角，以最大限度地成功建立多特許經營腫瘤業務。

The last few weeks have been extremely busy with the positive cabo ANDA ruling and the zanza collaboration announcement with Merck. As you saw in our press release issued an hour ago, Exelixis had a very successful third quarter across all components of our business.

過去幾週，我們非常忙於積極的 cabo ANDA 裁決以及 zanza 與默克 (Merck) 的合作公告。正如您在一小時前發布的新聞稿中看到的那樣，Exelixis 在我們業務的所有組成部分都取得了非常成功的第三季。

I'll start today with a strategic overview to frame our near-term and aspirational vision for the company, followed by financial and commercial updates from Chris and P.J. Amy and Dana are here as well and will address any technical R&D-related questions that come up in Q&A.

今天我將從策略概述開始，以框架我們對公司的近期和理想願景，然後是 Chris 和 P.J. 的財務和商業最新情況。中。

Exelixis is obviously at an inflection point with the clarity on the cabo ANDA and significant momentum for zanza. Cabo is having a strong 2024 and across literally all commercial metrics that we track routinely as performance indicators for the business, and we remain very bullish on cabo's revenue outlook into 2030.

隨著 cabo ANDA 的明確性和 zanza 的強勁勢頭，Exelixis 顯然正處於轉折點。Cabo 在 2024 年表現強勁，涵蓋了我們日常作為業務績效指標進行追蹤的所有商業指標，我們仍然非常看好 Cabo 到 2030 年的收入前景。

The zanza opportunity represents an important component of mid- and long-term revenue growth starting in the back half of this decade and potentially building into a dominant position in the 2030s. We're pleased to be working with Merck in kidney and head and neck cancers and that cost sharing, compound sharing agreements provides significant validation and momentum for zanza while we maintain full global commercial rights.

zanza 機會是本十年後半段開始的中長期收入成長的重要組成部分，並有可能在 2030 年代建立主導地位。我們很高興與默克在腎癌和頭頸癌領域合作，成本分攤、化合物共享協議為 zanza 提供了重要的驗證和動力，同時我們保留了完整的全球商業權利。

This collaborate with the competition model has been a pillar of our cabo development success, and we're pleased to get the first one moving with zanza. We're obviously not done in this regard and aim to expand into other collaborative opportunities in the future. With the zanza development plan, including six ongoing and planned pivotal trials, and more potentially on the horizon, we believe zanza has the opportunity to surpass cabo in scope and scale with one planned launch per year starting as early as 2026.

這種與競賽模式的合作是我們 cabo 開發成功的支柱，我們很高興第一個專案能夠與 zanza 一起發展。顯然我們在這方面還沒有完成，並計劃在未來擴展到其他合作機會。根據 zanza 開發計劃，包括六個正在進行和計劃中的關鍵試驗，以及即將到來的更多潛在試驗，我們相信 zanza 有機會在範圍和規模上超越 cabo，計劃最早從 2026 年開始每年推出一次。

Exelixis' aspirational goal is to be a market leader in both GU and GI oncology as our main therapeutic focus. Note that we are arguably already in the pole position as a GU oncology leader. So building momentum in the GI space is an immediate priority for both cabo and zanza. Additional zanza indications outside of GU and GI will be pursued opportunistically.

Exelixis 的理想目標是成為 GU 和 GI 腫瘤學的市場領導者，作為我們的主要治療重點。請注意，作為 GU 腫瘤學領導者，我們可以說已經處於領先地位。因此，在 GI 領域建立動力是 cabo 和 zanza 的當務之急。將適時尋求 GU 和 GI 以外的其他 zanza 適應症。

Building, developing, accelerating and pruning our early-stage pipeline is critically important as we advance towards a multi-franchise business. With three novel compounds in our early-stage clinical pipeline, including XL309, XPO1, and XL495, and several near-term INDs close behind, we plan to efficiently profile and prioritize potential winners for advancement into full development.

在我們邁向多特許經營業務的過程中，建立、開發、加速和修剪我們的早期產品線至關重要。憑藉我們早期臨床管道中的三種新型化合物，包括 XL309、XPO1 和 XL495，以及緊隨其後的幾個近期 IND，我們計劃有效地分析和優先考慮潛在的獲勝者，以推進全面開發。

As I said before, we're in the pivotal trial and [p-value] business where clear clinical differentiation in the mandatory prerequisite and the only viable path towards future commercial success. That's the essence of the cabo story and we're applying that filter to everything we do in R&D.

正如我之前所說，我們正處於關鍵試驗和 [p 值] 業務中，其中明確的臨床差異是強制性先決條件，也是通往未來商業成功的唯一可行途徑。這就是 cabo 故事的本質，我們正在將這種過濾器應用到我們研發中所做的一切。

We have a lot of exciting mature data from our early clinical efforts with zanza and we expect to present a significant amount of clinical data from STELLAR-001 and 002 throughout 2025 at major medical meetings. We'll provide more granularity on those data sets as abstracts are accepted and titles published. In addition, we plan to host another R&D Day in 2025 as well.

我們從 zanza 的早期臨床工作中獲得了許多令人興奮的成熟數據，我們預計在 2025 年全年在主要醫學會議上展示 STELLAR-001 和 002 的大量臨床數據。隨著摘要被接受和標題發布，我們將提供這些資料集的更詳細資訊。此外，我們也計劃在 2025 年再次舉辦研發日活動。

With the ANDA litigation now largely behind us, we expect future business development activities to ramp up. As highlighted previously, we are targeting late-stage clinical assets in the GU/GI oncology space, where we have clear conviction that clinical differentiation could drive ultimate commercial success.

隨著 ANDA 訴訟現已基本結束，我們預計未來的業務開發活動將會增加。正如前面所強調的，我們的目標是 GU/GI 腫瘤學領域的後期臨床資產，我們堅信臨床差異化可以推動最終的商業成功。

As we've highlighted previously, most biotech oncology launches since 2016 have been underwhelming, with cabo being one of the few standouts in terms of indication expansion and revenue growth. So we're very selective as we evaluate the clinical and commercial opportunity of late-stage assets. Exelixis could potentially pursue any type of transaction as we advance with a pragmatic, thoughtful and unambiguous focus on doing the right deal at the right valuation for the right asset.

正如我們之前所強調的，自 2016 年以來推出的大多數生物技術腫瘤藥物都表現平平，其中 Cabo 是在適應症擴展和收入增長方面為數不多的佼佼者之一。因此，我們在評估後期資產的臨床和商業機會時非常有選擇性。Exelixis 可能會尋求任何類型的交易，因為我們以務實、深思熟慮和明確的重點，以正確的資產以正確的估值進行正確的交易。

Finally, we're executing with an ambitious plan for building success as a multi-franchise company. To that end, I want to be very clear that we're committed to running the business and specifically R&D at recent expense levels for the foreseeable future. Our intention is to continue to rigorously and often aggressively prioritize spending and investments towards late-stage molecules to maximize our clinical and commercial success while we advance the pipeline, generate free cash and return a healthy portion of that free cash to shareholders.

最後，我們正在執行一項雄心勃勃的計劃，以實現作為多特許經營公司的成功。為此，我想非常明確地表明，我們致力於在可預見的未來以最近的費用水平運營業務，特別是研發。我們的目的是繼續嚴格且經常積極地優先考慮後期分子的支出和投資，以最大限度地提高我們的臨床和商業成功，同時我們推進管道，產生自由現金並將大部分自由現金返還給股東。

As you all know, clinical success never gets cheaper as compounds advance into late stage development. So we'll continue to prioritize our spending as we did at previous Exelixis inflection points over the course of the last decade. Our share buybacks over the last two years totaling $1 billion in commitment of another $500 million to the end of 2025 underscores our balanced and pragmatic approach to investing in the pipeline while returning cash flow to shareholders.

眾所周知，隨著化合物進入後期開發階段，臨床成功永遠不會變得更便宜。因此，我們將繼續優先考慮我們的支出，就像過去十年 Exelixis 拐點時所做的那樣。過去兩年，我們的股票回購總額為 10 億美元，並承諾到 2025 年底再回購 5 億美元，這突顯了我們在向股東返還現金流的同時對管道進行投資的平衡和務實的方法。

So with that background in place, let's review the key highlights for the quarter and drill down into additional details for our near and midterm vision for cabo and zanza. First, let's start with the quarter. Exelixis delivered outstanding financial performance in third-quarter 2024 with top- and bottom-line growth year over year, driven by the strength of the cabozantinib franchise, including increased demand, new patient starts and revenue.

因此，有了這些背景，讓我們回顧一下本季度的主要亮點，並深入了解我們對 Cabo 和 zanza 的近期和中期願景的更多細節。首先，我們從季度開始。在卡博替尼專營權實力的推動下，Exelixis 在 2024 年第三季度實現了出色的財務業績，收入和利潤同比增長，包括需求增加、新患者啟動和收入增加。

Cabometyx maintained its status as the leading TKI for RCC in the US with third-quarter 2024 cabo franchise net product revenues of $478 million, up 9% quarter over quarter compared to 2Q 2024 and 12% year over year compared to the third-quarter 2023. Global cabozantinib franchise net product revenues generated by Exelixis and its partners grew to $653 million in the third quarter of 2024.

Cabometyx 維持了美國 RCC 領先 TKI 的地位，2024 年第三季 cabo 特許經營產品淨收入為 4.78 億美元，較 2024 年第二季環比增長 9%，較 2023 年第三季同比增長 12% 。Exelixis 及其合作夥伴產生的全球卡博替尼特特許經營產品淨收入在 2024 年第三季成長至 6.53 億美元。

We have increased 2024 full-year net product revenue and total revenue guidance based on these robust results. And we're building on our strong commercial momentum as we wind up the year and head into 2025. Chris and PJ will provide details for the quarter in their prepared remarks.

基於這些強勁的業績，我們上調了 2024 年全年淨產品收入和總收入指引。隨著這一年的結束和 2025 年的到來，我們正在鞏固強勁的商業勢頭。Chris 和 PJ 將在準備好的發言中提供本季的詳細資訊。

Let's move next to our future, first focusing on cabo to drive near-term upside with strong projected revenue growth through the end of the decade and the potential for zanza to drive significant revenue opportunities starting as early as 2026 and accelerating into the 2030s and throughout that decade.

讓我們展望未來，首先關注 Cabo，透過預計到本十年末的強勁收入增長來推動近期上漲，以及 zanza 最早從 2026 年開始並加速到 2030 年代乃至整個時期帶來重大收入機會的潛力那個十年。

We're obviously pleased with the favorable ANDA ruling, which extends our cabo revenue running into early 2030 subject to Exelixis' potential additional regulatory exclusivity. The District Court's judgment is also subject to appeal by either party. I want to remind everyone that to the best of our knowledge, the FDA has not granted tentative approval of MSN's proposed ANDA product more than five years after their original submission.

我們顯然對有利的 ANDA 裁決感到高興，該裁決將我們的 Cabo 收入延長至 2030 年初，但須遵守 Exelixis 潛在的額外監管排他性。任何一方均可對地方法院的判決提出上訴。我想提醒大家的是，據我們所知，MSN 提議的 ANDA 產品在最初提交五年多後，FDA 尚未給予臨時批准。

Building off the strength of cabo's leadership position in RCC and potential new indications in NET in CRPC, our midterm projections highlight the potential for cabo to reach peak sales in the US of nearly $3 billion annually by 2030, with conservative estimates for growth of the base business, capturing a significant market share of the oral NET therapy indication and a limited opportunity in prostate cancer, which is heavily discounted until we get clarity on regulatory traction with our projected fourth-quarter filing.

憑藉 Cabo 在 RCC 領域的領導地位以及 CRPC 中 NET 的潛在新適應症，我們的中期預測強調，到 2030 年，CABO 在美國的年銷售額峰值有可能達到近 30 億美元（保守估計基數增長）業務，佔據了口服NET 治療適應症的重要市場份額，以及前列腺癌的有限機會，在我們透過預計的第四季度備案文件明確監管牽引之前，前列腺癌的機會會大幅折扣。

Let's turn next to zanza. Zanza has been largely under the radar from the Street's perspective with only a little over half of our covering analysts, including it in their revenue models. We anticipate it will gain more attention and prominence moving forward now with the positive cabo and a ruling and the recently announced collaboration with Merck.

讓我們轉向贊扎。從華爾街的角度來看，贊札基本上不受關注，只有略多於一半的分析師將其納入他們的收入模型中。我們預計，隨著積極的裁決和裁決以及最近宣布的與默克公司的合作，它將獲得更多關注和關注。

Specifically, zanza is built to expand on cabo's foundation and its early development plan provides a framework to surpass cabo's clinical and commercial success. Our first six zanza pivotal trials in four lead indications, including colon cancer, kidney cancer, head and neck cancer, and neuroendocrine tumors represents a large population of over 100,000 cancer patients annually, with overwhelming unmet medical need based on current standards of care with the cadre of generic and established drugs.

具體來說，zanza 是為了在 cabo 的基礎上擴展而建立的，其早期開發計劃提供了一個超越 cabo 的臨床和商業成功的框架。我們針對四個主要適應症的前六項zanza 關鍵試驗，包括結腸癌、腎癌、頭頸癌和神經內分泌腫瘤，每年涉及超過100,000 名癌症患者，根據當前的護理標準，絕大多數未滿足的醫療需求仿製藥和熟藥的骨幹隊伍。

Critically, recent progress across these trials reinforces our plan to secure our first potential approval for zanza as early as 2026. And then in subsequent years, one additional approval per year and in clinical and regulatory success.

至關重要的是，這些試驗的最新進展強化了我們的計劃，即確保 zanza 最早在 2026 年獲得首次潛在批准。然後在隨後的幾年中，每年都會獲得額外的批准，並在臨床和監管方面取得成功。

The zanza revenue opportunity with this first wave of label-enabling trials is substantial, with projected greater than $5 billion of top-line sales in the US to 2033, nearly equally split between GU and GI indications. Obviously, a second wave of new trials in GU/GI and other appropriate indications could advance this opportunity to the next level in the mid-30s and beyond. Zanza commercialization ex US, either by Exelixis or a potential new partner could drive significant commercial and financial upside as well.

第一波標籤支持試驗為 zanza 帶來的收入機會是巨大的，預計到 2033 年，美國的營收將超過 50 億美元，其中 GU 和 GI 適應症幾乎平等。顯然，第二波 GU/GI 和其他適當適應症的新試驗可能會將這一機會在 30 年代中期及以後提升到一個新的水平。Zanza 在美國以外的商業化（無論是由 Exelixis 還是潛在的新合作夥伴）也可以帶來顯著的商業和財務成長。

I'll wrap up here with a few additional comments on the pipeline, advancing behind cabo and zanza. We're thrilled but never satisfied with the depth and scope of the early pipeline assets we built and are moving into and through early clinical evaluation. Our small molecule and biologic approaches represent the opportunity to match the best modality with the most compelling tumor pathobiology as either monotherapies or combination partners, with checkpoint inhibitors or proprietary Exelixis molecules.

最後，我將針對 Cabo 和 zanza 後面的管道進行一些額外的評論。我們對我們建立的早期管道資產的深度和範圍感到興奮，但從未感到滿意，並且正在進入並通過早期臨床評估。我們的小分子和生物方法代表了將最佳治療方式與最引人注目的腫瘤病理學相匹配的機會，無論是單一療法還是與檢查點抑制劑或專有 Exelixis 分子的聯合療法。

We're advancing lead molecules in the synthetic lethality space with XL309 and XL495 and a variety of biologics in ADC, bispecific, and monoclonal antibody formats. The ultimate goal for all these programs is to rapidly generate clinical data, to prioritize advancement into full development, all with the goal of exceeding expectations as a multiproduct, multi-franchise oncology biopharma.

我們正在利用 XL309 和 XL495 以及各種 ADC、雙特異性和單株抗體形式的生物製劑來推進合成致死領域的先導分子。所有這些項目的最終目標是快速產生臨床數據，優先推動全面開發，所有這些目標都是超出預期，成為多產品、多特許經營的腫瘤生物製藥。

So with that, please see our press release issued an hour ago for our third-quarter 2024 financial results and an extensive list of key corporate milestones achieved in the quarter.

因此，請參閱我們一小時前發布的關於 2024 年第三季財務業績的新聞稿以及該季度實現的重要企業里程碑的詳細清單。

I'll now turn the call over to Chris.

我現在將把電話轉給克里斯。

Thanks, Mike. For the third quarter of 2024, the company reported total revenues of approximately $539.5 million, which included cabozantinib franchise net product revenues of $478.1 million. Cabometyx net product revenues were $475.7 million and included approximately $6.6 million in clinical trial sales which is similar to Q2 2024.

謝謝，麥克。2024年第三季度，該公司報告總收入約5.395億美元，其中包括卡博替尼特特許經營產品淨收入4.781億美元。Cabometyx 產品淨收入為 4.757 億美元，其中臨床試驗銷售額約為 660 萬美元，與 2024 年第二季相似。

Gross-to-net for the cabozantinib franchise in the third-quarter 2024 was 26%, which is lower than the gross to net we experienced in the second quarter 2024. This decrease in gross to net deductions in the third quarter 2024 is primarily related to lower Medicare Part D and DoD and TRICARE expenses. We are now projecting that our gross-to-net deductions for fiscal year 2024 will be between 28% and 29%.

卡博替尼特許經營權在 2024 年第三季的毛淨比為 26%，低於我們在 2024 年第二季的毛淨比。2024 年第三季總扣除額與淨額扣除額的減少主要與 Medicare D 部分、DoD 和 TRICARE 費用減少有關。我們現在預計 2024 財年的總扣除額將在 28% 至 29% 之間。

Our Cabometyx trade inventory was flat at 2.1 weeks on hand when compared to the second-quarter 2024. As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future.

與 2024 年第二季相比，我們的 Cabometyx 現有貿易庫存持平，為 2.1 週。不斷提醒人們，臨床試驗銷售歷來在季度之間波動，我們預計這種情況將持續到未來。

Total revenues included $60.2 million of license revenues for the third quarter of 2024. The largest contributor to our license revenues was $42 million from the royalties we earned from Ipsen and Takeda on their sales of cabozantinib in their territories.

總收入包括 2024 年第三季 6,020 萬美元的授權收入。我們的授權收入的最大貢獻者是我們從 Ipsen 和 Takeda 在其領土上銷售卡博替尼而獲得的特許權使用費中獲得的 4,200 萬美元。

Additionally, we recognized approximately $11 million in license revenues for a regulatory milestone resulting from Ipsen's filing of their application for a potential net indication with the European Medicines Agency. Our total operating expenses, including restructuring and impairment charges for the third quarter of 2024 were approximately $352 million compared to $361 million in the second quarter of 2024. The sequential decrease in these operating expenses was primarily driven by lower general and administrative expenses, offset by higher clinical trial and licensing costs in the third quarter of 2024.

此外，由於 Ipsen 向歐洲藥品管理局提交了潛在淨適應症申請，我們確認了約 1,100 萬美元的許可收入，這是一個監管里程碑。2024 年第三季我們的總營運費用（包括重組和減損費用）約為 3.52 億美元，而 2024 年第二季為 3.61 億美元。這些營運費用的環比下降主要是由於一般和管理費用的減少，但被 2024 年第三季臨床試驗和許可成本的增加所抵消。

After evaluating our near-term needs for both lab and office facilities on our Alameda campus, we put certain of our unoccupied lease facilities on the market for sublease. As a result, we recorded a non-cash impairment charge of approximately $52 million related to these lease facilities.

在評估了阿拉米達園區實驗室和辦公設施的近期需求後，我們將某些閒置的租賃設施放在市場上進行轉租。因此，我們記錄了與這些租賃設施相關的約 5,200 萬美元的非現金減損費用。

Provision for income taxes for the third quarter 2024 was approximately $37 million compared to a provision for income taxes of approximately $67 million for the second-quarter 2024. The company reported GAAP net income of approximately $118 million or $0.40 per share on a fully diluted basis for the third quarter 2024.

2024 年第三季的所得稅撥備約為 3,700 萬美元，而 2024 年第二季的所得稅撥備約為 6,700 萬美元。該公司公佈的 2024 年第三季 GAAP 淨利潤約為 1.18 億美元，即完全稀釋後每股 0.40 美元。

The company also reported non-GAAP net income of approximately $136 million or $0.47 per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $18 million of stock-based compensation expense net of the related income tax effect.

該公司還公佈了非 GAAP 淨利潤約為 1.36 億美元，即完全稀釋後每股收益 0.47 美元。非 GAAP 淨利潤不包括約 1800 萬美元的股票補償費用（扣除相關所得稅影響）的影響。

Cash and marketable securities as of September 30, 2024, were approximately $1.7 billion. In the third quarter of 2024, we repurchased approximately $12 million of Exelixis shares at an average price of $25.61 as part of the $500 million share repurchase program authorized by the Board in August 2024.

截至 2024 年 9 月 30 日，現金和有價證券約為 17 億美元。2024 年第三季度，作為董事會於 2024 年 8 月授權的 5 億美元股票回購計畫的一部分，我們以平均價格 25.61 美元回購了約 1,200 萬美元的 Exelixis 股票。

And finally, turning to our financial guidance for the full-year 2024. We are increasing and narrowing our total revenue and net product revenue guidance given Cabometyx strong net product revenue performance in Q2 and Q3 of this year. We are increasing our total revenue guidance to $2.15 billion to $2.2 billion.

最後，轉向我們 2024 年全年的財務指引。鑑於卡博替尼今年第二季和第三季強勁的淨產品收入表現，我們正在增加和縮小我們的總收入和淨產品收入指引。我們將總收入指引提高至 21.5 億美元至 22 億美元。

Additionally, we are increasing our net product revenue guidance to $1.775 billion to $1.825 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.

此外，我們還將淨產品收入指引提高至 17.75 億美元至 18.25 億美元，與我們先前提供的淨產品收入指引相比，這將我們的淨產品收入指引範圍的中點增加了 1 億美元。

Given where we are in the year, we are tightening our R&D and SG&A expense guidance ranges. Please see slide 20 of our Q3 earnings presentation for further detail.

鑑於今年的情況，我們正在收緊研發和銷售、一般行政費用指導範圍。請參閱我們第三季收益簡報的投影片 20 以了解更多詳情。

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

然後，我會將電話轉給 PJ。

Thank you, Chris. The third quarter of 2024 was a very strong quarter as the team continued to execute at a high level, which has resulted in Cabometyx continuing to be the number-one prescribed TKI in RCC. Additionally, Cabometyx remains the number-one TKI plus I/O combination in first-line renal cell carcinoma. Cabometyx TRx volume grew 9% year over year in Q3 2024 compared to Q3 2023. In the same period, the TKI market basket volume declined by 1%. Importantly, the business continues to grow in terms of demand in new patient starts, both of which were at an all-time high for CABOMETYX in the third quarter.

謝謝你，克里斯。2024 年第三季度是一個非常強勁的季度，團隊繼續保持高水準執行，這使得卡博替尼 (Cabometyx) 繼續成為 RCC 中排名第一的處方 TKI。此外，Cabometyx 仍然是一線腎細胞癌治療中排名第一的 TKI 加 I/O 組合。與 2023 年第三季相比，2024 年第三季 Cabometyx TRx 銷量較去年同期成長 9%。同期，TKI 市場籃子交易量下降了 1%。重要的是，該業務在新患者啟動的需求方面持續成長，這兩項需求在第三季均達到 CABOMETYX 的歷史最高水準。

Cabometyx continued to perform well from a marketplace and competitive perspective. Cabometyx again led the TKI market basket with TRx share increasing to 42%. As we have discussed previously, the first-line RCC market is extremely competitive and Q3 was the eighth full quarter in which CABOMETYX plus nivolumab remain the number-one prescribed TKI plus I/O combination in first-line RCC. And in particular, we're continuing to see strong growth in the community oncology setting.

從市場和競爭的角度來看，卡博替尼繼續表現良好。Cabometyx 再次領先 TKI 市場，TRx 市佔率增至 42%。正如我們之前所討論的，一線 RCC 市場競爭極其激烈，第三季度是 CABOMETYX 加納武單抗仍然是一線 RCC 中排名第一的處方 TKI 加 I/O 組合的第八個完整季度。特別是，我們繼續看到社區腫瘤學領域的強勁成長。

Looking forward, the commercial team is excited about the positive results from the CABINET study in neuroendocrine tumors as Exelixis aims to become a leader in the NET space. We believe the RCC market provides a blueprint for how the NET market could develop and grow in the coming years.

展望未來，商業團隊對 CABINET 研究在神經內分泌腫瘤方面取得的積極成果感到興奮，因為 Exelixis 的目標是成為 NET 領域的領導者。我們相信 RCC 市場為 NET 市場在未來幾年如何發展和成長提供了藍圖。

The global RCC market grew from approximately $3.7 billion in 2016 to approximately $10 billion in 2023, driven by new therapeutic launches, improved outcomes for patients, leading to longer treatment durations and longer survival with patients receiving more lines of therapy.

全球腎細胞癌市場從2016 年的約37 億美元增長到2023 年的約100 億美元，這得益於新療法的推出、患者治療效果的改善，從而延長了治療持續時間並延長了患者接受更多療法的存活期。

Similarly, early projections for the global NET market show it could almost double going from approximately $2.5 billion in 2023 to approximately $4.6 billion in 2030. Based on the CABINET study, Cabometyx is well positioned to capture a significant portion of this market pending regulatory. Beyond cabo, the STELLAR-311 study positions zanza well in the neuroendocrine tumor space. However, it is not included in these early projections.

同樣，對全球 NET 市場的早期預測顯示，其規模可能幾乎翻倍，從 2023 年的約 25 億美元增至 2030 年的約 46 億美元。根據 CABINET 研究，Cabometyx 處於有利地位，可以佔領這個等待監管的市場的很大一部分。除了 cabo 之外，STELLAR-311 研究還將 zanza 很好地定位在神經內分泌腫瘤領域。然而，它並未包含在這些早期預測中。

The CABINET data were enthusiastically received at this September's ESMO meeting and simultaneously published in the New England Journal of Medicine. As we talk to KOLs and physicians and market research, the efficacy data from CABINET is viewed favorably by prescribers in terms of progression-free survival, overall response rate, and disease control rate. They view the CABINET data as clinically meaningful and there is excitement for the potential for cabo to become available to NET patients.

CABINET 數據在今年 9 月的 ESMO 會議上受到熱烈歡迎，並同時發表在《新英格蘭醫學雜誌》上。當我們與 KOL、醫生和市場研究交談時，處方醫生對 CABINET 的療效數據在無惡化存活期、整體緩解率和疾病控制率方面給予了好評。他們認為 CABINET 數據具有臨床意義，並且對 Cabo 可供 NET 患者使用的潛力感到興奮。

The vast majority of physicians in our neuroendocrine tumor market research have experience with cabo in RCC, HCC, or DTC, which is consistent with Cabometyx's utilization data. These oncologists cite their experience with Cabometyx in these tumors as a positive factor, particularly when it comes to comfort with dose modification and toxicity management.

我們的神經內分泌腫瘤市場研究中的絕大多數醫生都有 Cabo 治療 RCC、HCC 或 DTC 的經驗，這與 Cabometyx 的使用數據一致。這些腫瘤學家將他們在這些腫瘤中使用卡博替尼的經驗視為一個積極因素，特別是在劑量調整和毒性管理方面。

The feedback and research clearly demonstrate that a regulatory approval for Cabometyx based on the CABINET study would have the potential to help a broad range of NET patients and address a significant unmet medical need.

回饋和研究清楚地表明，基於 CABINET 研究對 Cabometyx 進行監管批准將有可能幫助廣泛的 NET 患者並解決重大的未滿足的醫療需求。

The CABINET study had a diverse population that included patients regardless of site of disease origin, tumor grade, prior Lutathera, SSTR status, or functional status of the tumors. In our market research and KOL feedback, physicians cite the study design as a positive and that it covers a wide range of NET patients that they see in their practice as well as the fact that it is a contemporary data set and is inclusive of patients who have received prior Lutathera.

CABINET 研究的人群多種多樣，其中包括患者，無論其疾病起源部位、腫瘤分級、既往 Lutathera、SSTR 狀態或腫瘤功能狀態如何。在我們的市場研究和 KOL 回饋中，醫生認為研究設計是正面的，它涵蓋了他們在實踐中看到的廣泛的 NET 患者，而且它是一個當代資料集，包括以下患者：已收到先前的Lutathera。

The potential broad utility of cabo in NETs is a differentiator in this setting relative to other approved agents. Cabo may have the opportunity to be the easy choice to use in neuroendocrine tumors given that it was studied in all relevant clinical segments. In our analysis of the neuroendocrine prescriber universe, we see the vast majority of NET business potential in approximately 3,500 prescribers.

與其他核准的藥物相比，cabo 在 NET 中的潛在廣泛用途是這種情況下的一個區別。鑑於 Cabo 已在所有相關臨床領域進行了研究，因此它可能有機會成為治療神經內分泌腫瘤的簡單選擇。在我們對神經內分泌處方者領域的分析中，我們看到了約 3,500 名處方者的絕大多數 NET 業務潛力。

We are thrilled that about 80% of these prescribers already have experience writing Cabometyx. Of these 3,500 NET treaters, 2,800 are already current on-label targets for the sales force, indicating that access to them would be efficient. Also, of the 700 net prescribers who are not currently called on, the vast majority, 550 are co-located with current Cabometyx targets.

我們很高興這些處方者中約 80% 已經有服用卡博替尼的經驗。在這 3,500 名 NET 治療師中，有 2,800 名已經成為銷售人員目前的標籤目標，這表明接觸他們將是有效的。此外，在目前未徵召的 700 名淨處方者中，絕大多數有 550 名與目前的 Cabometyx 目標位於同一地點。

Pending FDA approval, we are confident that we will be able to rapidly reach and educate this net prescriber universe efficiently given the overlap with current sales targets and the fact that we expanded our GI sales team.

在等待 FDA 批准的過程中，考慮到與當前銷售目標的重疊以及我們擴大了 GI 銷售團隊的事實，我們相信我們將能夠快速有效地接觸和教育這個淨處方者群體。

Turning to the net market. We have conducted market research, which shows that oral therapies account for approximately 25% of the first-line market and 50% of the utilization in the second- and third-line-plus settings. Currently available oral options do not have the same breadth of data across all disease characteristics, including site of origin, grade, and functional status.

轉向網路市場。我們進行的市場調查顯示，口服療法約佔第一線市場的 25%，佔二線和三線以上市場的 50%。目前可用的口服選擇在所有疾病特徵（包括起源部位、等級和功能狀態）方面沒有相同廣度的數據。

Also, in market research, physicians do not view the toxicity profile of these agents in a favorable manner. The majority of NET patients will receive multiple lines of therapy. And there is lack of optimal sequencing data in this setting, particularly in patients previously treated with Lutathera. All of this taken together underscores the need for a contemporary data set that is broadly applicable to address the unmet medical need for this heterogeneous patient population.

此外，在市場研究中，醫生並沒有以有利的方式看待這些藥物的毒性特徵。大多數 NET 患者將接受多種治療。在這種情況下，特別是先前接受 Lutathera 治療的患者，缺乏最佳定序數據。所有這些綜合起來強調了對廣泛適用的當代數據集的需求，以解決這種異質患者群體未滿足的醫療需求。

Looking at the small molecule market for NETs in 2025 using contemporary pricing, the small molecule opportunity would be approximately $1 billion in the US. Additionally, upon approval, Cabometyx would be the only branded small molecule therapy competing in the neuroendocrine tumor market. This is a critical point as cabo would have a clear advantage in promotional share of voice and be the only oral therapy with comprehensive patient support services.

使用目前定價來看 2025 年 NET 的小分子市場，美國的小分子機會約為 10 億美元。此外，一旦獲得批准，Cabometyx 將成為神經內分泌腫瘤市場上唯一競爭的品牌小分子療法。這是一個關鍵點，因為 cabo 在推廣話語權方面具有明顯的優勢，並且是唯一提供全面患者支持服務的口服療法。

With the CABINET data and a focused launch strategy that leverages the positive prescriber experience with cabo, Exelixis is well positioned to rapidly penetrate this market. Furthermore, as Exelixis aims to become a leader in the neuroendocrine tumor market, we are excited about the planned STELLAR-311 trial of zanza in NETs.

憑藉 CABINET 數據和利用 cabo 積極的處方者體驗的重點推出策略，Exelixis 已做好快速滲透該市場的準備。此外，由於 Exelixis 的目標是成為神經內分泌腫瘤市場的領導者，我們對計劃在 NET 中進行 zanza 的 STELLAR-311 試驗感到興奮。

The commercial team is excited and motivated by the launch planning and preparation for the opportunity in NETs. The cabo franchise is closing out 2024 with significant momentum in our currently approved indications and a potential regulatory approval of Cabometyx in NET would provide the opportunity to continue the growth and momentum in the coming years.

商業團隊對 NET 機會的啟動規劃和準備感到興奮和激勵。Cabo 特許經營權將於 2024 年結束，我們目前批准的適應症勢頭強勁，而 Cabometyx 在 NET 中的潛在監管批准將為未來幾年繼續增長和勢頭提供機會。

Looking through the cabo lens, it is clear that great data with a great team behind it, can significantly help patients and expand markets. We have seen this in RCC as the oral therapy market has expanded by nearly 40% since the beginning of 2021.

從 Cabo 的角度來看，很明顯，出色的數據及其背後的優秀團隊可以顯著幫助患者並擴大市場。我們在 RCC 中看到了這一點，因為自 2021 年初以來，口服治療市場擴大了近 40%。

We are extremely excited about the portfolio of announced Phase 3 zanza trials. We are motivated to expand the cabo franchise to a kinase inhibitor franchise with zanza having the potential to help patients in tumors where cabo has demonstrated activity such as NETs and RCC, as well as new tumors such as colorectal and head and neck cancers. So we can continue to help more patients with cancer as we strengthen our GU and GI franchises.

我們對已宣布的 zanza 3 期試驗組合感到非常興奮。我們有動力將 cabo 特許經營權擴展到激酶抑製劑特許經營權，而 zanza 有潛力幫助治療 cabo 已表現出活性的腫瘤（如 NET 和 RCC）以及新腫瘤（如結直腸癌和頭頸癌）患者。因此，我們可以在加強 GU 和 GI 特許經營權的同時，繼續幫助更多癌症患者。

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

然後，我會將電話轉回給麥克。

All right. Thanks, PJ. I'd like to close our call today by thanking all of our very talented and dedicated employees who are unwavering and fulfilling our mission to help cancer patients recover stronger and live longer, successfully litigating the ANDA with the results of extremely hard work and perseverance over literally years led by our excellent legal team in partnership with our outside counsel WilmerHale.

好的。謝謝，PJ。在今天的電話會議結束時，我要感謝我們所有非常有才華和敬業的員工，他們堅定不移地履行我們的使命，幫助癌症患者康復得更強壯，活得更長久，透過極其努力的工作和堅持不懈的努力，成功地對ANDA 提起了訴訟。

I'm grateful to the numerous internal employees who were interviewed deposed and otherwise engaged in supporting this litigation, including scientists and discovery and manufacturing leaders and members of the commercial and medical affairs teams as well as finance and public affairs. It was a true team effort across the entire company, and I appreciate the commitment of everyone who is involved in seeing you through to fruition.

我感謝眾多接受採訪、被解職或以其他方式參與支持這項訴訟的內部員工，其中包括科學家、發現和製造領導者以及商業和醫療事務團隊以及財務和公共事務團隊的成員。這是整個公司真正的團隊努力，我感謝所有參與幫助您取得成果的人的承諾。

I'd also like to recognize the team involved in successfully negotiating the Merck clinical development collaboration, which was another cross-functional effort led by our business development colleagues. With this collaboration, we're on our way to helping many more cancer patients with zanza. I'd also like to thank our commercial organization, which has driven cabo's outperformance and contributed to our strong financial results over the first nine months of this year.

我還要感謝參與默克臨床開發合作成功談判的團隊，這是我們業務開發同事領導的另一項跨職能工作。透過此次合作，我們將透過 zanza 幫助更多癌症患者。我還要感謝我們的商業組織，它推動了 cabo 的出色表現，並為我們今年前九個月的強勁財務業績做出了貢獻。

And finally, I'd like to recognize our entire R&D organization who have propelled our pipeline efforts forward at a rapid pace. The collective Exelixis team has accomplished a great deal thus far in 2024 and with much more to come on the horizon as we strive to deliver results for cancer patients and our shareholders. We look forward to updating you on our progress.

最後，我要感謝我們整個研發組織，他們推動了我們的研發工作快速向前發展。到目前為止，Exelixis 團隊在 2024 年已經取得了巨大成就，在我們努力為癌症患者和股東帶來成果的過程中，還將取得更多成就。我們期待向您通報我們的最新進展。

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

感謝您對 Exelixis 的持續支持和興趣，我們很高興現在開始提問。

(Operator Instructions)

（操作員說明）

Asthika Goonewardene, Truist.

Asthika Goonewardene，真理主義者。

Congrats on the beating the race here. It's very encouraging to see that -- since I'm restricting to just one question, I'll just focus on the Merck collaboration that was recently announced. Can you maybe give us some color on the diligence process that way into that deal? How extensive was it?

恭喜你在這裡擊敗了比賽。看到這一點非常令人鼓舞——因為我只限於回答一個問題，所以我將只關注最近宣布的與默克的合作。您能否為我們介紹一下該交易的盡職調查過程？範圍有多大？

I know it's hard to comment on that, but that will be useful. And the reason I'm asking is because Merck already has lenvatinib, a drug that were tolerability and half-life has been debilitating to its development. I just want to try to get a sense of how what they did when they did the analysis with zanza.

我知道很難對此發表評論，但這很有用。我之所以問這個問題，是因為默克公司已經有了樂伐替尼，這種藥物的耐受性和半衰期一直在削弱其開發。我只是想嘗試了解他們在使用 zanza 進行分析時做了什麼。

Yes. Asthika, it's Mike. Thanks for the question. Yes. It's a hard question to answer. We don't want to speak for Merck. We certainly want to respect the process that took place over many, many, many months. We're thrilled to be working with arguably our main competitor in the RCC space with cabo moving forward together with them with zanza.

是的。阿斯蒂卡，是麥克。謝謝你的提問。是的。這是一個很難回答的問題。我們不想代表默克公司說話。我們當然希望尊重經過許多、許多、許多個月所發生的過程。我們很高興能與我們在 RCC 領域的主要競爭對手合作，cabo 和 zanza 與他們一起前進。

So we're excited about moving forward. Obviously, there's nobody better in the industry to actually executing trials than Merck. So the fact that they're running two large pivotal trials is just awesome from our point of view. And we're certainly excited to work with them going forward with these first set of trials with zanza.

因此，我們對前進感到興奮。顯然，業界沒有人比默克公司更擅長實際執行試驗。因此，從我們的角度來看，他們正在進行兩項大型關鍵試驗這一事實真是太棒了。我們當然很高興與他們合作，推進 zanza 的第一組試驗。

Jason Gerberry, Bank of America Securities.

Jason Gerberry，美國銀行證券公司。

This is Chi on for Jason. Thanks for taking our question. Congrats on securing a favorable ruling on cabo IP. One on business development. I understand you look to do the right view of the right valuation for the right asset within the GU/GI space. I'm curious if you have a preference for modality, whether it's small molecule, monoclonal bispecific or ADC and whether you have a feeling on the size of the deal, you will consider for BD?

這是 Jason 的 Chi。感謝您提出我們的問題。恭喜 Cabo IP 獲得有利裁決。一是關於業務發展。我理解您希望對 GU/GI 空間內的正確資產進行正確的估值。我很好奇您是否對模式有偏好，無論是小分子、單克隆雙特異性還是 ADC，以及您是否對交易規模有感覺，您會考慮 BD？

Yes. Thanks for the question on BD. Look, we're agnostic to, I think, almost all those factors. We are focused on active molecules, as I mentioned in our prepared remarks, that we have conviction on in terms of having the ability or the opportunity to generate differentiating clinical data that we can then convert into commercial success.

是的。感謝您關於 BD 的問題。聽著，我認為我們對幾乎所有這些因素都是不可知的。正如我在準備好的演講中提到的那樣，我們專注於活性分子，我們堅信有能力或機會產生差異化的臨床數據，然後將其轉化為商業成功。

I mean, again, that's the learning from cabo. That's the cabo lens that we base everything on. So we obviously want to be able to work in the GU/GI space because we're really set up to execute very well there, both clinically and commercially.

我的意思是，這也是向卡波學習的地方。這就是我們一切的基礎的 Cabo 鏡頭。因此，我們顯然希望能夠在 GU/GI 領域開展工作，因為我們確實已經準備好在那裡執行得很好，無論是臨床還是商業。

But in terms of modalities, we're open. We're looking for active molecules that we think we can build into a franchise, number one; and then get over the goal line numerous times from a regulatory point of view with the obvious upside in helping more patients and then having that translate into commercial success.

但就方式而言，我們持開放態度。我們正在尋找我們認為可以建立特許經營權的活性分子，第一；然後從監管的角度多次超越目標線，在幫助更多患者方面有明顯的好處，然後將其轉化為商業成功。

Silvan Tuerkcan, Citizens JMP.

Silvan Tuerkcan，公民 JMP。

Congrats on the beat. I would like to know about maybe that there's a gap between -- obviously, between your near-term growth with Canada and then you want to do with BD and then your earlier pipeline, but maybe talking about the earlier pipeline, your synthetic lethality assets. When can we expect some data there? And how have you -- what's your view on the space with all the competitive data that has come out recently here?

恭喜節拍。我想知道，顯然，你在加拿大的近期成長與你想要的 BD 和你早期的管道之間可能存在差距，但也許談論的是早期的管道，你的合成殺傷力資產。我們什麼時候可以期待那裡的數據？您對最近發布的所有競爭數據有何看法？

Dana, why don't you take that one first from a competitive point of view? And then I think both Amy and I can provide some color commentary as well so --.

達納，為什麼不從競賽的角度來看第一個呢？然後我想艾米和我也可以提供一些色彩評論，所以--.

Sure, sure. So thanks for the question. Just regarding -- so let's just be clear, we've got two compounds in the clinic now that are in the synthetic lethality space, XL309, which targets you US1. And as we announced in the press release, XL495 has now been filed in the Phase 1 trial is running.

當然，當然。謝謝你的提問。只是關於——所以讓我們澄清一下，我們現在在診所有兩種化合物，屬於合成致死性領域，XL309，它的目標是 US1。正如我們在新聞稿中宣布的那樣，XL495 現已備案，第一階段試驗正在運行。

As I highlighted at our R&D Day presentation in December, both of those molecules are substantially differentiated from the other molecules that are in the clinic regarding 309. We now believe we are the front runner in the clinic with Roche pulling back on their molecule to rework and work through some PK issues. They really hit a ceiling in terms of exposure.

正如我在 12 月的研發日演講中所強調的那樣，這兩種分子與臨床中的 309 的其他分子有很大區別。現在，我們相信我們是臨床上的領導者，羅氏正在對他們的分子進行改造並解決一些 PK 問題。他們的曝光率確實達到了上限。

So we're quite happy with our position now in the clinic with that compound. And then with 495, the PK1 inhibitor, the main competition there is from repair with lunosertib. And as we presented at R&D Day in December, our compound, we believe, has a PK advantage as well as selectivity advantage. With our PK modeling, we believe we can hit well into the efficacious range of exposure with once-daily dosing. And we also have -- we also hit about 33% or 35% fewer kinases in a broad selectivity panel compared to that competitor compound. So we think there might be a safety advantage as well.

因此，我們對該化合物目前在臨床上的地位感到非常滿意。然後是 495（PK1 抑制劑），主要競爭來自 lunosertib 的修復。正如我們在 12 月的研發日上所介紹的那樣，我們相信我們的化合物具有 PK 優勢和選擇性優勢。透過我們的 PK 模型，我們相信我們可以透過每日一次的劑量達到有效的暴露範圍。與競爭對手的化合物相比，我們在廣泛的選擇性組中檢測到的激酶也減少了約 33% 或 35%。因此我們認為這也可能具有安全優勢。

Amy?

艾米？

Yes. So I know we spent a lot of time talking about cabo and zanza because those are sort of the nearer-term things. But trust me, Dana is keeping the development team very busy with some of these assets in the pipeline as they advance. And they are we really are focusing on best-in-class.

是的。所以我知道我們花了很多時間討論 Cabo 和 zanza，因為這些都是近期的事情。但請相信我，Dana 正在讓開發團隊非常忙碌，隨著這些資產的進展，這些資產正在醞釀中。我們確實專注於一流的產品。

And with the modality that we have around USP1 and single-stranded break repair, there's really an opportunity to not only extend the reach of PARP inhibition and BRCA mutations, but potentially also take it beyond BRCA mutated patients into HRD and potentially other indications.

透過我們圍繞 USP1 和單鏈斷裂修復的模式，確實有機會不僅擴大 PARP 抑制和 BRCA 突變的範圍，而且還可能將其擴展到 BRCA 突變患者之外的 HRD 和潛在的其他適應症。

And we have one ADC with MMA payload that targets 5T4 advancing. And now as Dana just pointed out, FPI to 495. So we are busy with the pipeline. There's a lot coming. There's more to come. And we are really focusing on that just as much and as intensely as we are focusing on zanza and maturing it.

我們有一款具有 MMA 有效負載的 ADC，目標是 5T4 推進。現在正如 Dana 剛剛指出的，FPI 達到 495。所以我們正忙於管道。還有很多事情要發生。還有更多的事情要做。我們確實非常關注這一點，就像我們關注贊扎並使其成熟一樣。

Michael Schmidt, Guggenheim Securities.

邁克爾·施密特，古根漢證券公司。

Thanks for taking my question. Great to see reacceleration of cabo sales growth to double digits here in the second half of this year. Could you just comment on what's been the primary driver for that?

感謝您提出我的問題。很高興看到今年下半年 Cabo 銷售成長再次加速至兩位數。您能否評論一下造成這種情況的主要驅動因素是什麼？

And then on zanza congrats on the Merck collaboration. I'm just curious if you could comment on the two planned Phase 3 studies of zanza and belzutifan in RCC and how you think about positioning that versus cabo and the ARCUS HIF2 inhibitor longer term?

然後在 zanza 上祝賀默克公司的合作。我只是好奇您能否對 zanza 和 belzutifan 在 RCC 中的兩項計劃中的 3 期研究發表評論，以及您如何考慮將其與 cabo 和 ARCUS HIF2 抑製劑進行長期比較？

Okay. PJ, take the first one, and I'll comment on the second one. Okay.

好的。PJ，拿第一個，我來評論第二個。好的。

Yes. Thanks for the question, Michael. We're certainly very pleased. As I mentioned, with the quarter and the significant momentum we have with cabo now and the franchise. As I've mentioned previously, we were sort of continuing to see new highs in both demand and new patient starts and really primarily driven by first-line RCC.

是的。謝謝你的提問，麥可。我們當然非常高興。正如我所提到的，隨著本季度的發展以及我們與 cabo now 和特許經營權的巨大勢頭。正如我之前提到的，我們的需求和新患者開始數量繼續創下新高，這主要是由一線 RCC 推動的。

We've maintained our market leadership position there. And as we see increasing new patient starts there, we continue to see patient stacking and sort of demand moving forward. So very pleased with that. And really, it comes down to we've got great data across the board there and then a great team really focused on executing at a high level and just continue to see that moving forward.

我們在那裡保持了市場領導地位。當我們看到越來越多的新患者開始在那裡時，我們繼續看到患者堆積和某種需求向前發展。對此非常滿意。事實上，這取決於我們在各個方面都獲得了出色的數據，然後一個優秀的團隊真正專注於高水準的執行，並繼續看到這一點向前發展。

In terms of zanza with Merck, again, we've agreed with Merck to keep the details to ourselves for now. As I'm sure time goes on and trials are moving forward. Merck again, who's running those, trials will communicate the design and those kinds of issues. So stay tuned on that. I don't have much to say in terms of other competitive programs.

就與默克公司的讚札而言，我們再次同意默克公司目前對細節保密。我確信時間在流逝，考驗正在向前推進。默克公司正在運行這些試驗，將傳達設計和此類問題。所以請繼續關注。至於其他競技項目我就不多說了。

We're very, very happy to be partnered with Merck, which has the only FDA-approved HIF inhibitor on the market right now. And with the momentum we've got with zanza and certainly with their firepower, we're very excited to be moving forward here with them going forward.

我們非常非常高興與默克公司合作，默克公司擁有目前市場上唯一經 FDA 批准的 HIF 抑制劑。憑藉我們與 zanza 的勢頭，當然還有他們的火力，我們非常高興能與他們一起前進。

Greg Renza, RBC Capital Markets.

格雷格‧倫札 (Greg Renza)，加拿大皇家銀行資本市場部。

Great. Mike and team, congrats on the quarter and also on the string of recent great updates. Mike, maybe sticking with zanza and we appreciate the layout of some of the peak opportunity longer term. That's great to see.

偉大的。麥克和團隊，祝賀本季以及最近的一系列重大更新。麥克，也許會堅持贊扎，我們很欣賞一些長期高峰機會的佈局。很高興看到這一點。

Just wanted to ask if you could maybe elaborate a little bit further on some of the assumptions there, you certainly mentioned of the patient stacks, which is helpful that the differentiating data that you would expect to get to those numbers and even the unadjusted nature. But as we think about sort of those breakdowns with respect to GU and GI and head and neck, would be great.

只是想問您是否可以進一步詳細說明那裡的一些假設，您當然提到了患者堆棧，這對於您期望獲得這些數字甚至未經調整的性質的區分數據很有幫助。但當我們考慮到 GU 和 GI 以及頭頸方面的這些細分時，那就太好了。

And certainly, related, Mike, what is the optimal pipeline constructed a portfolio construct for you having gone back -- having lived through the cabo days establishing and defending the competitive positioning is zanza at sort of that single asset to get that full white space and diversity of opportunity, the right way of thinking for Exelixis moving forward?

當然，相關的，麥克，為你建立一個投資組合結構的最佳管道是什麼——經歷了建立和捍衛競爭地位的卡波時代，是讚札在某種單一資產上獲得完整的空白空間和機會的多元性，Exelixis 前進的正確思考方式？

Yes. Thanks, Greg. I appreciate the comments and the question. Look, as we talked about previously, cabo provides the foundation for which we're building future opportunities with zanza going forward. We've learned a lot with cabo; we've spent 15+ years developing that molecule.

是的。謝謝，格雷格。我感謝您的評論和問題。看，正如我們之前談到的，cabo 為我們與 zanza 一起建立未來機會奠定了基礎。我們從 cabo 中學到了很多；我們花了 15 年以上的時間來開發該分子。

We've had a string of successes. We've done, I think, a lot of really great science at the lab bench, in the clinic, been able to learn a lot as an organization to be able to maneuver. So think we're applying all those learnings from all those different lanes into how we view the zanza opportunity.

我們取得了一系列的成功。我認為，我們在實驗室和臨床上做了很多非常偉大的科學工作，作為一個組織能夠學到很多東西，以便能夠進行操作。因此，我們正在將所有這些不同管道的經驗教訓應用到我們如何看待贊札機會中。

In terms of details on assumptions, we have a very sophisticated commercial organization that does modeling professionally. I mean, this is what they do. So we'll share that -- those assumptions and that data in time. I think it's important for the sell side now to be quite frank to roll up their sleeves, sharpen pencils, and look at these opportunities, start doing your own modeling. And we can talk about that together when some of that data, some of your modeling is more mature in the future.

在假設的細節方面，我們有一個非常複雜的商業組織，可以專業地進行建模。我的意思是，這就是他們所做的。因此，我們將及時分享這些假設和數據。我認為賣方現在必須坦率地捲起袖子，削尖鉛筆，看看這些機會，開始做自己的建模。當一些數據、一些建模在未來更加成熟時，我們可以一起討論這個問題。

But we're thrilled about having zanza at to have a molecule at this stage in six ongoing or planned pivotal trials. We think there's more opportunity on the way collaboration with Merck top-line data in 303 in 2025, potentially first launch in '26. The momentum is palpable right now, coming off the strength of cabo.

但我們很高興 zanza 在現階段能夠在六項正在進行或計劃的關鍵試驗中獲得一種分子。我們認為 2025 年與默克 303 頂線數據的合作有更多機會，可能在 26 年首次推出。現在，卡波的勢頭是顯而易見的。

So we're excited to be -- again, to be past the ANDA, so everybody can focus on the business moving forward -- positive direction forward without having some of the overhang that we've had with the ANDA and other stuff in the past. So happy to engage with you going forward and looking forward to making this happen.

因此，我們很高興能夠再次通過 ANDA，讓每個人都可以專注於業務的發展，朝著積極的方向前進，而不會出現我們在 ANDA 和其他方面遇到的一些懸念。很高興與您繼續合作，並期待實現這一目標。

Yaron Werber, TD Cowen.

亞龍·韋伯，TD·考恩。

Congrats on the quarter and then the litigation. So Mike, just the one thing that really caught my mind is your comment about potentially looking at late-stage deals. I think you've kind of commented that, but I think this is kind of something you're highlighting a bit more now, at least in our view. Am I thinking about this correctly? And are you open for acquisitions? Or is this like really in-licensing only?

恭喜這個季度，然後是訴訟。麥克，真正引起我注意的一件事是你關於可能考慮後期交易的評論。我想你已經對此發表了評論，但我認為你現在更多地強調了這一點，至少在我們看來是這樣。我的想法正確嗎？你們對收購持開放態度嗎？或者這只是真正的許可？

Yes, Yaron. So thanks for the question and the commentary. Look, we've been talking about late-stage opportunities for a while now. As you heard from Dana and Amy, we have a very full early-stage pipeline. We like these molecules. We think they're best in class. We have a lot of work to do to interrogate and then prioritize what moves into full development.

是的，亞龍。感謝您的提問與評論。看，我們談論後​​期機會已經有一段時間了。正如您從 Dana 和 Amy 那裡聽到的，我們有一個非常完整的早期管道。我們喜歡這些分子。我們認為他們是同類中最好的。我們還有很多工作要做來審視並優先考慮哪些內容可以進入全面開發。

So to be quite frank, we don't need more development candidates, more INDs, more Phase 1 molecules because we've got our plate full, right, in terms of what we're doing internally, right? We're interested in building Exelixis into a multiproduct multi-franchise oncology business. That's the goal.

坦白說，我們不需要更多的候選藥物、更多的 IND、更多的 1 期分子，因為就我們內部所做的事情而言，我們的工作已經完成了，對吧？我們有興趣將 Exelixis 打造成多產品、多特許經營的腫瘤業務。這就是目標。

And to do that, and obviously, we have cabo going full steam. Zanza has got great traction. But if we can find again, the right asset that has the right level of -- gives us the right level of conviction on being able to generate differentiating clinical data that can then drive commercial performance, we're very interested in finding a way to bring that molecule or those molecules into the organization.

為了做到這一點，顯然，我們讓 Cabo 全力以赴。Zanza 受到了極大的關注。但是，如果我們能夠再次找到具有正確水平的正確資產，讓我們對能夠產生差異化的臨床數據從而推動商業業績產生正確的信念，我們非常有興趣找到一種方法將那個分子或那些分子帶入組織中。

As I said in my prepared remarks, we have any number of different potential business development opportunities going forward. We can do virtually anything we think makes sense but it's got to be the right deal, the right valuation with the right asset.

正如我在準備好的演講中所說，我們未來有許多不同的潛在業務發展機會。我們幾乎可以做任何我們認為有意義的事情，但它必須是正確的交易，正確的估值和正確的資產。

Jay Olson, Oppenheimer.

傑·奧爾森，奧本海默。

Wow, congrats on all the progress across so many fronts. Really appreciate the optimism around zanza an impressive $5 billion peak US sales potential. Can you comment on what gives you the conviction at this point in time to share your thoughts on the commercial potential? Is it related to the Merck collaboration or something else?

哇，祝賀在這麼多方面取得的所有進展。真的很欣賞 zanza 在美國峰值銷售潛力高達 50 億美元的樂觀情緒。您能否評論一下是什麼讓您在此時此刻有信心分享您對商業潛力的看法？這與默克的合作有關還是其他什麼？

And since you have global rights to zanza, why did you focus your outlook on US revenues? And how are you thinking about the ex US opportunity?

既然您擁有 zanza 的全球版權，為什麼您將展望重點放在美國收入上？您如何看待前美國的機會？

Yes, Jay, thanks for the question. It's really the right time, as I said in my kind of my early comments this afternoon. We're at this inflection point organizationally where we're past the ANDA. We have that overhang finally removed. We want everybody, all of our various stakeholders to look at us today as we're going forward with a successful product in cabo, an asset in zanza that has multiple, I would say, high PTRS shots on goal in terms of new indications that we think could really build on cabo's success and expand it from the scale and scope that we're seeing currently with cabo.

是的，傑伊，謝謝你的提問。正如我在今天下午的早期評論中所說，這確實是正確的時間。我們正處於組織上的拐點，我們已經過了 ANDA。我們終於消除了這個懸垂的部分。我們希望每個人，我們所有的利益相關者今天都能看到我們，因為我們正在卡波推出一款成功的產品，這是讚扎的一項資產，我想說，就新跡象而言，它有許多高PTRS 射門命中目標，我們認為，可以真正以 cabo 的成功為基礎，並將其擴大到我們目前所看到的 cabo 的規模和範圍。

So it's really the right time to get everybody focused on the future. Again, as I mentioned with Greg, we've had a challenging time getting people to pay attention to us from the standpoint of where we're at and where we're going. So to get you guys, everybody off the sidelines and looking at us in maybe a new light with the momentum we've got right now, I think, is super important.

因此，現在確實是讓每個人專注於未來的正確時機。再次，正如我與格雷格所提到的那樣，我們經歷了一段充滿挑戰的時期，讓人們從我們所處的位置和未來的角度來關注我們。因此，我認為，為了讓你們、每個人都離開場邊，以新的眼光看待我們現在所擁有的勢頭，這是非常重要的。

We are focused on building a multi-product, multi-franchise business because that's where the value is for patients and for shareholders. And with the momentum we have with cabo and with zanza and the pipeline, lots of optionality, BD-wise, we're super excited about our path going forward.

我們專注於建立多產品、多特許經營業務，因為這才是患者和股東的價值所在。憑藉我們與 cabo、zanza 和管道的勢頭，以及 BD 方面的大量可選性，我們對未來的道路感到非常興奮。

Andy Hsieh, William Blair.

安迪謝，威廉布萊爾。

Thanks for taking our question. Really encouraged to see the durability of cabo's leadership there. Two questions, if I may. One for PJ. So there's a pet imaging agent for C89 for RCC that could get approval potentially next year. I'm just wondering how you view that potentially pulling some patients who otherwise would have gone undiagnosed -- and would that be a potential upside to your $10 billion TAM that you laid out for RCC.

感謝您提出我們的問題。看到卡波在那裡的持久領導力，我真的很受鼓舞。如果可以的話，有兩個問題。一張是給 PJ 的。因此，用於 RCC 的 C89 寵物顯影劑可能會在明年獲得批准。我只是想知道您如何看待這可能會吸引一些原本無法確診的患者，這對您為 RCC 投入的 100 億美元 TAM 是否有潛在的好處。

Second question has to do with also the $1 billion TAM that you mentioned for the small molecule NET. Just kind of back of the level of calculation, I think you're probably projecting anywhere from a five- to six-month duration. I'm curious if you look at the landscape, especially with like Afinitor label, some of the durations for earlier lines are basically 9, 10 months.

第二個問題也與您提到的小分子 NET 的 10 億美元 TAM 有關。只是計算水平的後面，我認為您可能會預測五到六個月的持續時間。我很好奇，如果你看看情況，特別是像 Afinitor 這樣的標籤，早期生產線的一些持續時間基本上是 9、10 個月。

So is it unreasonable to assume that if zanza entrenches earlier in the treatment landscape for NET, that duration will be significantly higher, given that it's a more indolent cancer? Thank you.

那麼，考慮到 zanza 是一種惰性更強的癌症，假設如果 zanza 在 NET 治療領域更早佔據一席之地，那麼持續時間會明顯更長，這是不合理的嗎？謝謝。

Yes, Andy, thanks for the questions. Briefly, with regards to RCC, I think a lot of patients are in the funnel, and we're certainly, as I mentioned, pleased with our performance there and our leading TRx market share, which continues to grow, now up to 42% in that market basket. And I think that market, most of the patients are being treated. And I think the bar for success, particularly in the first line and really even with cabo in the second line is quite high. So I view that market as relatively stable in the near-term vis-à-vis other mechanisms of action.

是的，安迪，謝謝你的提問。簡而言之，關於RCC，我認為許多患者都在漏斗中，正如我所提到的，我們當然對我們在該領域的表現以及我們領先的TRx 市場份額感到滿意，該份額持續增長，目前已高達42%在那個市場籃子裡。我認為在這個市場上，大多數患者正在接受治療。我認為成功的門檻，特別是在第一線，甚至在第二線的 Cabo 上，也是相當高的。因此，我認為與其他行動機制相比，該市場在短期內相對穩定。

And thinking about NET, as you mentioned, yes, as I mentioned, about a quarter of the patients in first-line NET are getting oral therapies approximately 50% in the second, third-line settings getting orals. And we basically use I won't go into the details of all of our assumptions, but we've done a lot of market research there and understand it very well and using durations that we see from that.

考慮到NET，正如您所提到的，是的，正如我所提到的，大約四分之一的一線NET 患者正在接受口服治療，而在第二、三線治療中，大約50% 的患者接受口服治療。我們基本上使用我不會詳細介紹我們所有假設的細節，但我們在那裡做了很多市場研究並且非常了解它並使用我們從中看到的持續時間。

I certainly think you're correct. Obviously, the earlier you do go the longer the duration of therapy, particularly in neuroendocrine tumors, which is a bit more indolent than some other solid tumors. And I think there is the potential for zanza in the long term, pending trial results, regulatory approval, et cetera, of having earlier utilization and therefore, a longer duration. I think that's certainly right.

我當然認為你是對的。顯然，越早治療，治療的持續時間就越長，尤其是神經內分泌腫瘤，它比其他一些實體瘤更惰性。我認為從長遠來看，在等待試驗結果、監管部門批准等方面，zanza 有可能更早使用，因此持續時間更長。我認為這當然是對的。

But what I'd say in the near term, we're really excited about cabo and the potential approval that we're looking at with a PDUFA date of April 3. And as we think about that market and that $1 billion market in 2025 that I mentioned, we think we're incredibly well positioned to not only penetrate it and achieve a lot of that market, but do it rapidly.

但我想說的是，在短期內，我們對 cabo 以及我們正在考慮的 PDUFA 日期為 4 月 3 日的潛在批准感到非常興奮。當我們思考這個市場以及我提到的 2025 年 10 億美元市場時，我們認為我們處於非常有利的位置，不僅可以滲透該市場並獲得大量市場，而且可以快速實現。

Really, the more we think about it is we're the only branded oral therapy in the space, it really gives us a big advantage in terms of the promotional share of voice and really just the ability to help patients comprehensive patient support services, we think it will be really important. So we're really excited about that opportunity in the near term.

真的，我們越想越是我們是該領域唯一的品牌口腔治療，它確實給我們帶來了很大的優勢，在宣傳份額方面，而且實際上有能力幫助患者提供全面的患者支持服務，我們認為這將非常重要。因此，我們對近期的這個機會感到非常興奮。

David Lebowitz, Citi.

大衛‧勒博維茨，花旗銀行。

Jon for David. For cabo and neuroendocrine tumors, I know you just -- you're touching on some of the commercial considerations for this market. But what sort of work still needs to be done before a potential launch? And assuming approval, how should we be thinking about initial launch cadence? Are there any existing indications that might serve as sort of a proxy for how we should be thinking about early uptake?

喬恩換大衛。對於卡波腫瘤和神經內分泌腫瘤，我知道您正在觸及這個市場的一些商業考慮。但在潛在的推出前還需要完成哪些工作呢？假設獲得批准，我們應該如何考慮最初的發布節奏？是否有任何現有跡象可以作為我們應該如何考慮早期採用的代理？

Yes. Thanks for the question, Jonathan. Our team, as I mentioned, are incredibly excited and motivated across the board getting ready for this launch. We will be ready to go on day one as we always are for launching a new indication.

是的。謝謝你的提問，喬納森。正如我所提到的，我們的團隊非常興奮並積極主動地為此次發布做好準備。我們將在第一天就做好準備，就像我們一貫為推出新適應症所做的那樣。

And frankly, the more we do it, I think the better we get at it. So what I would anticipate here, as I mentioned, not having really the amount of competition that you have in RCC, which is, for example, very competitive. We would anticipate a very strong uptake right from the beginning. And we believe our data is very strong. I went into some detail on the prescriber universe. The sales force has been expanded and we're frankly really ready to go.

坦白說，我們做得越多，我認為我們就做得越好。因此，正如我所提到的，我在這裡預計不會有像 RCC 那樣的競爭，例如，競爭非常激烈。我們預計從一開始就會有非常強烈的採用。我們相信我們的數據非常有力。我詳細介紹了處方者領域。銷售隊伍已經擴大，坦白說，我們已經做好了準備。

And we believe we can really move into the market rapidly and efficiently. And really, we're very excited about the opportunity to help potentially a lot of patients with neuroendocrine tumors.

我們相信我們真的可以快速有效地進入市場。事實上，我們對有機會幫助許多神經內分泌腫瘤患者感到非常興奮。

Akash Tewari, Jefferies.

阿卡什·特瓦里，杰弗里斯。

This is Anastasia on for Akash. Congrats on the quarter and on the recent IP decision. Just a couple on my end. The first is about the potential to expand Merck partnership beyond RCC and head and neck. Do you think that's possible as we get more data from the PD-L1 Fb specifics?

我是阿納斯塔西婭 (Anastasia) 為阿卡什 (Akash) 發言。恭喜本季和最近的知識產權決策。我這邊只有一對。第一個是關於將默克合作夥伴關係擴展到 RCC 和頭頸部以外的潛力。隨著我們從 PD-L1 Fb 細節中獲得更多數據，您認為這可能嗎？

And then the second question is, do you think that your head and neck data would compare well versus mirrors in the PD-L1 refractory population? Or do you see this kind better or worse on our front?

第二個問題是，您認為您的頭部和頸部資料與 PD-L1 難治性人群中的鏡子相比效果好嗎？還是你認為我們前線的這種情況是好還是壞？

Thanks for the questions. Amy, why don't you start with the head and neck question, and then I'll address the Merck?

感謝您的提問。艾米，為什麼不先從頭頸問題開始，然後我再回答默克公司的問題？

Yes. Yes. So when it comes to zanza, we're obviously interested in developing it broadly as it's best-in-class. And we have multiple collaborations to that and with other IOs, including atezo, including nivolumab, and now recently with pembrolizumab in head and neck.

是的。是的。因此，當涉及 zanza 時，我們顯然有興趣廣泛開發它，因為它是同類中最好的。我們為此以及其他 IO 進行了多次合作，包括 atezo、nivolumab，以及最近在頭頸領域與 pembrolizumab 的合作。

So whether or not there's expansion beyond head and neck, I would say we're always looking. And of course, we're interested in getting zanza into as many indications as possible. What we combine with remains to be seen.

因此，無論是否有頭部和頸部以外的擴張，我想說我們一直在尋找。當然，我們有興趣讓 zanza 適應盡可能多的適應症。我們結合什麼還有待觀察。

And I guess, when it comes to the data with the bispecifics in the PD-1 refractory space, I'm not quite sure we're competing with them. We have about a year lead time with Bicara -- against Bicara in the frontline space and Merus. And we are leveraging that lead time very aggressively to ensure sites that we can enroll and read that study out. How it plays out in the refractory, so maybe I didn't understand the question, but I'm not sure I'm able to answer that for Bicara.

我想，當談到 PD-1 難治性領域中雙特異性藥物的數據時，我不太確定我們正在與他們競爭。我們與比卡拉（Bicara）有大約一年的領先時間——在前線空間對抗比卡拉（Bicara）和梅魯斯（Merus）。我們正在非常積極地利用這項準備時間，以確保我們可以註冊並閱讀該研究的網站。它是如何在耐火材料中發揮作用的，所以也許我不明白這個問題，但我不確定我能否為比卡拉回答這個問題。

Stephen Willey, Stifel.

史蒂芬威利，斯蒂菲爾。

Congrats on the quarter. So I know you previously characterized STELLAR-305 as a phased I think you're now kind of explicitly referring it to it as a Phase 3. So just wondering if you've completed that formal assessment of Phase 2 data to officially transition into Phase 3. And I guess if so, can you speak to those metrics that you're evaluating to make that decision and just whether you might be disclosing that data at some point?

恭喜本季。所以我知道您之前將 STELLAR-305 描述為階段性的，我認為您現在明確地將其稱為階段 3。所以想知道您是否已完成對第二階段數據的正式評估以正式過渡到第三階段。我想如果是這樣，您能否談談您正在評估以做出決定的那些指標，以及您是否可能在某個時候披露這些數據？

Amy, please.

艾米，請。

Yes, quickly. Thanks for the question. It is a Phase 2, 3. We are still in ruling, and we'll disclose data when it is mature.

是的，很快。謝謝你的提問。這是第二、第三階段。我們仍在裁決中，成熟後我們會揭露數據。

Ash Verma, UBS.

阿什‧維爾瑪，瑞銀集團。

So I just wanted to understand the capital allocation priorities from here. You have a pretty sizable buyback program outstanding. Do you think this was the right focus when you were dealing with the IP uncertainty? But now that the IP decision is behind you, why not focus most of your capital deployment on the pipeline build out?

所以我只是想從這裡了解資本配置的優先順序。你們有一個相當大的回購計劃尚未完成。您認為在處理知識產權不確定性時，這是正確的關注嗎？但既然智慧財產權決策已經過去，為什麼不將大部分資本部署集中在管線建設上呢？

Yes. Thanks for the question. It's Mike. Yes, I think with our cash flows, we can do all of the above. So as I mentioned in my prepared remarks, we're committed to being very disciplined as we go forward in terms of expense levels, kind of keeping expense levels kind of where they are currently for the foreseeable future. With the cash flows that we have and project, we think we can continue investing in the pipeline, doing BD, and then returning cash to shareholders.

是的。謝謝你的提問。是麥克。是的，我認為憑藉我們的現金流，我們可以做到上述所有事情。因此，正如我在準備好的發言中提到的，我們致力於在費用水平方面保持嚴格的紀律，在可預見的未來將費用水平保持在目前的水平。憑藉我們擁有和預期的現金流，我們認為我們可以繼續投資管道，開展業務發展，然後將現金返還給股東。

Peter Lawson, Barclays.

彼得·勞森，巴克萊銀行。

Just I have a question around slide 9 that the guidance around zanza. So should we read that as kind of sounds a $5 billion in 2033 and then what carbo kind of essentially declined to zero?

只是我有一個關於幻燈片 9 的問題，即有關 zanza 的指導。那麼，我們是否應該將其理解為聽起來有點像 2033 年 50 億美元，然後哪種碳基本上下降到零？

Peter, it's Mike. I think the cabo LOE is in the 2030 time frame. So as outlined on Slide 9. That is a 2024 number. And we see zanza growing dramatically over the next several years as these pivotal trials read out, and if successful, could drive a lot of upside growth for zanza.

彼得，是麥克。我認為 Cabo LOE 的時間範圍是 2030 年。正如幻燈片 9 所述。那是 2024 年的數字。隨著這些關鍵試驗的結果，我們看到 zanza 在未來幾年內將急劇增長，如果成功，可能會推動 zanza 的大幅上行成長。

Etzer Darout, BMO Capital Markets.

Etzer Darout，BMO 資本市場。

It's Luke Shumway on for Etzer. For the Zanza colorectal cancer update next year, the primary endpoint is OS in patients without liver mets. How readily identify or patients without liver mets in the real world? And would that require a companion diagnostic?

盧克·沙姆威 (Luke Shumway) 替補埃策 (Etzer)。對於明年的 Zanza 大腸癌更新，主要終點是沒有肝臟代謝的患者的 OS。在現實世界中如何容易辨識出沒有肝代謝異常的患者？這需要伴隨診斷嗎？

This is Amy. Thanks for the question. So this is an imaging assessment. All patients, when they're diagnosed with advanced disease tend to get scanned from head to toe and that absolutely includes a liver scan, especially for patients with colorectal because of its predilection to metastasizes to the liver.

這是艾米。謝謝你的提問。這是影像學評估。所有患者在被診斷出患有晚期疾病時，往往都會接受從頭到腳的掃描，其中絕對包括肝臟掃描，特別是對於結直腸癌患者，因為其傾向於轉移到肝臟。

So all patients with colorectal will have a scan of their liver. And it's pretty straightforward to identify whether or not there is a disease present in the liver or not. So it's an imaging. It's a clinical assessment. It's actually not a companion diagnostic, and it's readily utilized by physicians every day.

因此，所有結直腸患者都將接受肝臟掃描。確定肝臟是否有疾病非常簡單。所以這是一個成像。這是臨床評估。它實際上不是伴隨診斷，醫生每天都很容易使用它。

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

Thanks for the time to share your quarterly results. So congratulations on all the great quarter and the recent progress on many fronts. With the breadth of clinical program opportunities for cabo and zanza in the GU and GI space, what indications or therapeutic technologies are left out there of interest when you're looking for assets during the BD endeavors? Are you specifically looking for assets primarily for novel combinations with cabo and zanza or monotherapy options out there to cover the GI indications?

感謝您抽空分享您的季度業績。因此，請祝賀所有偉大的季度以及最近在許多方面取得的進展。隨著 GU 和 GI 領域 Cabo 和 zanza 臨床計畫機會的廣泛性，當您在 BD 工作中尋找資產時，哪些適應症或治療技術被遺漏了？您是否正在專門尋找主要用於 Cabo 和 zanza 的新穎組合或單一療法選項的資產來涵蓋胃腸道適應症？

Thank you for the question. It's Mike. Yes, I would say simplest answer is all of the above. Our conviction is around clinical differentiation that can drive commercial success. If those assets are combined with zanza other XL molecules in the pipeline, great. If their stand-alone agents or combined with checkpoints that's fine, too.

謝謝你的提問。是麥克。是的，我想說最簡單的答案就是以上所有內容。我們的信念是臨床差異化可以推動商業成功。如果這些資產與正在研發中的 zanza 其他 XL 分子結合，那就太好了。如果他們的獨立代理或與檢查點相結合也很好。

So again, we're agnostic when it comes to modality, MOA, type of transaction. We're focused on a really high level of conviction on clinical differentiation that then drives commercial success.

再說一遍，當涉及交易方式、MOA 和類型時，我們是不可知的。我們專注於對臨床差異化的高度信念，從而推動商業成功。

Chris Shibutani, Goldman Sachs.

克里斯·澀谷，高盛。

Thank you, Mike. As you think about how you're staffing your teams and obviously monitoring how you're spending, noting that SG&A, the R&D has come down, what are the areas that you feel are going to be important to expand further?

謝謝你，麥克。當您考慮如何為團隊配備人員並明顯監控您的支出方式時，注意到SG&A、研發已經下降，您認為哪些領域對於進一步擴展至關重要？

Thanks, Chris. Yes, I think we're in a pretty good spot right now. Obviously, if we have, in the out years, continued clinical success and we need to augment what we've got commercially, that's a relatively easy and incremental growth as we've seen so far in our planning for the NET space.

謝謝，克里斯。是的，我認為我們現在處於一個非常好的位置。顯然，如果我們在過去的幾年裡持續取得臨床成功，並且我們需要擴大我們在商業上的成果，那麼正如我們迄今為止在NET 領域的規劃中所看到的那樣，這是一個相對容易的增量增長。

But in terms of the company, we have 100-plus employees. We are -- I think we're leading mean in terms of what we are aspiring to do organizationally in terms of building this multi-franchise oncology business. But we've got a lot of momentum in the organization from an R&D point of view, from a commercial point of view with the right size G&A to make it all work. So we're excited about where we are. And we think we've got the right team and certainly the right horsepower both talent-wise as well as energy wise to make that happen as we go forward.

但就公司而言，我們有100多名員工。我認為，在我們渴望在組織上建立這種多特許經營腫瘤業務方面，我們處於領先地位。但從研發的角度來看，從商業的角度來看，我們的組織有很大的動力，並有適當規模的一般管理費用來使這一切發揮作用。所以我們對我們所處的位置感到興奮。我們認為我們擁有合適的團隊，當然也擁有合適的人才和精力，可以在我們前進的過程中實現這一目標。

Joe Catanzaro, Piper Sandler.

喬·卡坦扎羅，派珀·桑德勒。

I had one on the PK MIT program since it's now in Phase 1. So you mentioned on restorative and that program seems to have honed in a biomarker-selected population in endometrial and ovarian cancer. So maybe can you speak to your strategy around tumor-type selection and biomarkers that you may be using. And then you also mentioned potential cytotoxic combinations for that program. Wondering if maybe you could elaborate a bit more on that.

我在 PK MIT 專案中有一個項目，因為它現在處於第一階段。所以你提到了恢復性治療，該計劃似乎已經在子宮內膜癌和卵巢癌的生物標記選擇人群中得到了磨練。那麼，也許您可以談談您可能使用的腫瘤類型選擇和生物標記的策略。然後您還提到了該計劃的潛在細胞毒性組合。想知道您是否可以對此進行詳細說明。

Yes. Thanks for the question, Joe. This is Dana. I'll take that one. So yes, so XL495 as you're quite as a PM1 inhibitor, which has shown synthetic lethality in tumors that have increased cyclin E levels that can be driven by a number of different actual genetic biomarkers, including CCNE amplification and a few others.

是的。謝謝你的提問，喬。這是達納。我會接受那個。所以，是的，所以 XL495 就像 PM1 抑制劑一樣，它在腫瘤中顯示出合成致死性，細胞週期蛋白 E 水平增加，可由許多不同的實際遺傳生物標記驅動，包括 CCNE 擴增和其他一些。

So we've certainly identified those biomarkers in our preclinical models. But we've also identified some other interesting biomarkers that we have not yet disclosed, which we're also quite excited about. So we are looking at all of these biomarkers in the Phase 1 study.

因此，我們確實已經在臨床前模型中識別了這些生物標記。但我們也發現了一些其他有趣的生物標記物，但我們尚未披露，對此我們也感到非常興奮。因此，我們正在第一階段研究中研究所有這些生物標記。

We have also conducted quite a few combination studies preclinically looking at, as you mentioned, cytotoxics, but also a very expanded range of drugs that have direct or indirect impacts on generating sort of a replication stress type phenotype in the cells. And we have a lot of opportunities there.

正如您所提到的，我們也進行了相當多的臨床前聯合研究，著眼於細胞毒性藥物，而且還研究了一系列非常廣泛的藥物，這些藥物對在細胞中產生某種複製應激型表型有直接或間接的影響。我們在那裡有很多機會。

So we haven't really disclosed details of our Phase 1 program yet. We will do that at some point in the future. But until then, we're looking at quite a few different hypotheses in the clinic for both biomarkers and combinations.

所以我們還沒有真正透露第一階段計畫的細節。我們將在未來的某個時候這樣做。但在那之前，我們正在臨床上針對生物標記和組合研究相當多不同的假設。

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, Varant, for closing remarks.

謝謝。女士們先生們，我不會在隊列中顯示任何其他問題。現在我想將電話轉回給主持人 Varant，讓其致閉幕詞。

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

謝謝托旺達，也謝謝大家今天加入我們。如果您有任何我們在今天的電話會議中無法解決的其他問題，我們歡迎您的後續電話。

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。