BeOne Medicines AG (ONC) 2025 Q1 法說會逐字稿

Good day everyone. Welcome to BeiGene's Q1 2025 earnings call webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session.

大家好。歡迎收聽百濟神州 2025 年第一季財報電話網路直播。所有線路均已靜音，以防止任何背景噪音。演講者發言後，將進行問答環節。

At this time, I would like to turn the call over to the company.

現在，我想將電話轉給公司。

Hello and welcome. Thanks for joining us today. I'm Dan Maller, Head of Investor Relations at BeiGene.

您好，歡迎光臨。感謝您今天加入我們。我是百濟神州投資者關係主管 Dan Maller。

Before we begin, please note that you can find additional materials, including a replay of today's webcast and presentation on the investor relations section of our website, ir.beigene.com.

在我們開始之前，請注意，您可以在我們網站 ir.beigene.com 的投資者關係部分找到其他資料，包括今天的網路廣播和簡報的重播。

I would like to remind all participants that during this call, we may make forward-looking statements regarding, among other things, the company's future prospects and business strategy. Actual results may differ materially from those indicated in the forward-looking statements as a result of various factors, including those risks discussed in our most recent periodic report filed with the SEC.

我想提醒所有參與者，在本次電話會議中，我們可能會對公司未來前景和業務策略等做出前瞻性陳述。由於各種因素，包括我們向美國證券交易委員會提交的最新定期報告中討論的風險，實際結果可能與前瞻性陳述中所示的結果有重大差異。

Please also carefully review the forward-looking statements disclaimer slide deck accompanies this presentation. Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our investor relations website along with our earnings release. All information in this presentation is as of the date of the presentation, and we undertake no duty to update such information unless required by law.

也請仔細閱讀本簡報附帶的前瞻性聲明免責聲明投影片。本次電話會議上討論的 GAAP 和非 GAAP 財務指標之間的對帳在我們簡報的附錄中提供，該附錄與我們的收益報告一起發佈在我們的投資者關係網站上。本簡報中的所有資訊均截至簡報發布之日，除非法律要求，否則我們不承擔更新此類資訊的義務。

Now turning to today's call, as outlined on slide three. John Oyler, our Co-Founder, Chairman and CEO, will provide a business update; Xiaobin Wu, our President and Chief Operating Officer, will provide an update on our global commercial progress; Matt Shaulis, our General Manager of North America, will provide an update on the US commercial performance of Brukinsa; Lai Wang, our Global Head of R&D, will discuss our R&D and pipeline progress; and Aaron Rosenberg, our CFO, will review the first quarter financial results and financial guidance. We will then open the call to your questions.

現在轉到今天的電話會議，如第三張投影片所述。我們的共同創辦人、董事長兼執行長 John Oyler 將提供業務最新情況；我們的總裁兼營運長吳曉斌將提供我們全球商業進展的最新情況；我們的北美總經理 Matt Shaulis 將提供 Brukinsa 美國商業表現的最新情況；我們的全球研發主管 Lai Wang 將討論我們的財務領導和管道審查；然後我們將開始回答您的問題。

Pass the call over to John. John?

把電話轉給約翰。約翰？

Thank you, Dan, and welcome everyone to our Q1 earnings call.

謝謝你，丹，歡迎大家參加我們第一季財報電話會議。

Last quarter's call, I spoke about three priorities for 2025; the first was solidifying and deepening our hematology franchise leadership, the second was advancing our prolific pipeline of internally developed assets, and the third was driving superior financial performance. I'm excited to share with you how we delivered on these priorities through the first quarter.

上個季度的電話會議上，我談到了 2025 年的三個優先事項：第一是鞏固和深化我們的血液學特許經營領導地位，第二是推進我們豐富的內部開發資產管道，第三是推動卓越的財務業績。我很高興與大家分享我們在第一季是如何實現這些優先事項的。

BeiGene is the only company with an internally discovered and wholly owned portfolio of potentially best in class molecules across all three foundational mechanisms in CLL. We believe our relentless focus on serial innovation in CLL uniquely positions us to address the full scope of unmet patient need across all lines of therapy and subpopulations.

百濟神州是唯一一家擁有內部發現並全資擁有的、涵蓋慢性淋巴細胞白血病 (CLL) 所有三種基礎機制、具有潛在最佳治療潛力的分子組合的公司。我們相信，我們對 CLL 領域系列創新的不懈關注使我們能夠滿足所有治療領域和亞群中所有未滿足的患者需求。

Brukinsa is the best in class BTK inhibitor that serves as the backbone of our franchise. In the US, Brukinsa is the leader in new patient starts for both frontline and relapse refractory CLL and across all of its approved indications. Brukinsa possesses the broadest label of any BTKi. And for the first time, Brukinsa has surpassed both ibrutinib and acalabrutinib in overall US quarterly revenue and continues to outpace its BTKi competitors in year over year growth.

Brukinsa 是同類產品中最好的 BTK 抑制劑，也是我們特許經營的支柱。在美國，Brukinsa 在治療第一線和復發難治性慢性淋巴細胞白血病 (CLL) 的新患者以及所有核准適應症方面均處於領先地位。Brukinsa 擁有所有 BTKi 中最廣泛的標籤。Brukinsa 首次在美國季度總收入上超越了 ibrutinib 和 acalabrutinib，並且在同比增長方面繼續超過其 BTKi 競爭對手。

This leadership follows the science and the data and reflects Brukinsa's clear clinical differentiation. Brukinsa is the only BTKi to exhibit complete and sustained inhibition, and it's the only BTKi to demonstrate superior efficacy and safety in a head to head trial against ibrutinib. And anchored by its best in class clinical data, Brukinsa has now treated over 200,000 patients globally.

這種領導力遵循科學和數據，反映了 Brukinsa 明確的臨床差異化。Brukinsa 是唯一表現出完全和持續抑制的 BTKi，也是唯一在與 ibrutinib 的正面交鋒試驗中表現出卓越療效和安全性的 BTKi。憑藉其一流的臨床數據，Brukinsa 現已在全球治療了超過 20 萬名患者。

Sonro, our potentially best in class BCL-2 inhibitor, continues to advance rapidly through late stage clinical development. We've completed enrollment in our phase three celestial trial of Sonro+Zanu in treatment naive CLL, and we've progressed two additional phase three trials as lie will review.

Sonro 是我們潛在的同類最佳 BCL-2 抑制劑，在後期臨床開發中繼續快速進展。我們已經完成了 Sonro + Zanu 治療初治慢性淋巴細胞白血病 (CLL) 的第三階段臨床試驗的招募，並且我們已取得另外兩項第三階段試驗的進展，我們將進行審查。

Importantly, we've reached our first registrational milestone for Sonro, with a regulatory filing submitted in China, and we plan to submit our first global filing in the second half of this year. These filings marked the beginning of Sonro's evolution in a potential game-changing therapy across multiple B cell malignancies.

重要的是，我們已經達到了 Sonro 的第一個註冊里程碑，在中國提交了監管文件，我們計劃在今年下半年提交第一份全球文件。這些申請標誌著 Sonro 開始在多種 B 細胞惡性腫瘤治療領域邁出改變遊戲規則的一步。

We're the leading next generation of innovation in CLL with our first in class BTK CDAC program, which is now dosed over 600 patients and continues to progress rapidly. We've reached an agreement with the FDA on a phase three dose, and we've already initiated our first phase three trial with plans to initiate another phase three trial against Pirtobrutinib in the second half of the year. We continue to expect data from our potentially pivotal phase two trial next year and pending positive results intend to complete global regulatory submissions.

我們憑藉一流的 BTK CDAC 計劃引領 CLL 領域的下一代創新，該計劃目前已為 600 多名患者提供服務，並且進展迅速。我們已與 FDA 就第三階段劑量達成協議，並已啟動第一階段第三階段試驗，並計劃在今年下半年啟動針對 Pirtobrutinib 的另一項第三階段試驗。我們繼續期待明年可能具有關鍵意義的第二階段試驗的數據，並在取得積極成果後打算完成全球監管提交。

Outside of heme, we continue to advance one of the broadest solid tumor pipelines in the industry. Our CDK4 inhibitor continues to advance rapidly, with over 300 patients enrolled, including over 100 in just the past two months.

除了血紅素之外，我們還將繼續推動業界最廣泛的實體腫瘤研發管線之一。我們的 CDK4 抑制劑持續快速進展，已有超過 300 名患者入組，其中僅在過去兩個月就入組了 100 多名患者。

Our B7-H4 program, a key area of enthusiasm, has completed seven monotherapy cohorts with promising signs of clinical activity. We enrolled the first patients in both of our Claudin6xCD3 by specific program for gynecological and other solid tumors and our second generation BCL2 for metastatic breast cancer. And our PRMT5 inhibitor also entered the clinic in early Q1, marking another milestone in our targeted lung cancer therapy portfolio.

我們的 B7-H4 計畫是一個備受關注的關鍵領域，已完成七個單一療法隊列，並顯示出良好的臨床活動跡象。我們透過針對婦科和其他實體腫瘤的 Claudin6xCD3 特定計劃以及針對轉移性乳癌的第二代 BCL2 計劃招募了首批患者。我們的PRMT5抑制劑也在第一季初進入臨床，標誌著我們針對肺癌的治療組合的另一個里程碑。

This year, we anticipate more than 10 proof of concept readouts across our solid tumor pipeline, each representing a potential near-term value inflection point. These assets feature differentiated, potentially first and or best in class profiles, and have the potential to deliver transformational impact for both patients and shareholders.

今年，我們預計在我們的實體腫瘤管道中將有超過 10 個概念驗證讀數，每個讀數都代表一個潛在的近期價值轉折點。這些資產具有差異化、潛在一流或最佳的特性，並有可能為患者和股東帶來變革性影響。

Our internal clinical development team of 3,700 plus continues to demonstrate time, cost, and quality advantages that are driving higher ROI for each R&D dollar spent, and we're routinely seeing proof of these advantages and programs in competitive settings like our BTK CDAC, our BCL2, and our CDK4 inhibitor, just to name a few.

我們擁有超過 3,700 名成員的內部臨床開發團隊，他們不斷展示時間、成本和品質優勢，從而為每一美元的研發投入帶來更高的投資回報率，並且我們經常在競爭環境中看到這些優勢和計劃的證據，例如我們的 BTK CDAC、我們的 BCL2 和我們的 CDK4 抑製劑，僅舉幾例。

Moving to financial performance, we achieved a major milestone in Q1, GAAP profitability for the first time. Aaron will provide more detail later in the call, but these strong quarterly results pace us on solid footing to deliver on our full year of financial guidance.

談到財務業績，我們在第一季實現了重要的里程碑，首次實現了 GAAP 盈利。亞倫將在電話會議的稍後部分提供更多細節，但這些強勁的季度業績為我們實現全年財務指導奠定了堅實的基礎。

I'd like to close by sharing a few reflections on the external landscape as our industry continues to navigate in an increasingly challenging and complex global environment. I believe our unique model positions us exceptionally well to succeed in spite of today's challenges.

最後，我想分享一些對外部情況的看法，因為我們的行業正在日益充滿挑戰和複雜的全球環境中前進。我相信，儘管面臨當今的挑戰，我們獨特的模式仍將使我們獲得巨大的成功。

Over the past 15 years we've built an organization from scratch that is technology enabled, time and cost advantaged, and now vertically integrated. It was built not only to survive but to thrive in a world with pricing pressure.

在過去的 15 年裡，我們從零開始建立了一個擁有技術支援、時間和成本優勢、並且垂直整合的組織。它的建立不僅是為了在充滿價格壓力的世界中生存，也是為了蓬勃發展。

In today's macro environment, a global manufacturing footprint and regional resilient supply chain are essential to ensuring product availability and operational continuity. This has been a foundational principle of our operations across the US, Europe, China, and other key markets. We've realized this vision with action, including most recently an $800 million dollar investment in our Hopewell, New Jersey manufacturing facility which opened in 2024.

在當今的宏觀環境下，全球製造足跡和區域彈性供應鏈對於確保產品可用性和營運連續性至關重要。這是我們在美國、歐洲、中國和其他主要市場開展業務的基本原則。我們已透過行動實現了這一願景，包括最近向位於新澤西州霍普韋爾的製造工廠投資 8 億美元，該工廠將於 2024 年開業。

With the landscape around trade policies and tariffs will continue to evolve, our commitment to regional manufacturing helps us mitigate potential risks and maintain reliable supply.

隨著貿易政策和關稅情勢的不斷變化，我們對區域製造業的承諾有助於我們降低潛在風險並維持可靠的供應。

Finally, I'm pleased to announce that the shareholders have approved our re-domiciling to Switzerland from the Cayman Islands, as well as our name change to BeOne Medicines, reflecting our continued evolution into a globally diversified oncology leader and our deepening ties to the world-class Swiss biotech ecosystem.

最後，我很高興地宣布，股東已批准我們將公司註冊地從開曼群島遷至瑞士，並將公司名稱更改為 BeOne Medicines，這反映了我們持續發展成為全球多元化腫瘤學領導者，以及我們與世界一流的瑞士生物技術生態系統的深化聯繫。

And with that, I'll pass it over to Xiaobin to provide a global commercial update.

接下來，我將把這個任務交給小斌，讓他提供全球商業更新。

Thank you, John. Our global development strategy and board try design have resulted in the broadest label and the widespread coverage for Brukiprnsa and Tevimbra. We have achieved a significant global reach in a short period of time and have now traded over 1.7 million cancer patients with a 30s.

謝謝你，約翰。我們的全球發展策略和董事會嘗試設計為 Brukiprnsa 和 Tevimbra 帶來了最廣泛的標籤和覆蓋範圍。我們在短時間內取得了顯著的全球影響力，目前已為超過 170 萬名 30 歲以上的癌症患者提供了治療。

This foundation foundational assets are well positioned to deliver meaningful benefit to patients worldwide. We have built the commercial infrastructure to successfully launch and scale across more than 80 markets. This strong foundation also positions us to fully leverage our global network to support internal clinic, development and drive the successful commercialization of our pipeline.

該基金會的基礎資產能夠為全球患者帶來有意義的利益。我們已經建立了商業基礎設施，成功在 80 多個市場推出並擴展。這一堅實基礎也使我們能夠充分利用我們的全球網路來支援內部診所、開發並推動我們產品線的成功商業化。

In the first quarter, global sales were $1.1 billion growing 49% from Q1 '24. The US, our largest market grew 60% on strong booking demand growth as met we'll discuss later. In addition, Tevimbra was approved for frontline ESCC in the US during the quarter.

第一季度，全球銷售額為 11 億美元，較 2024 年第一季成長 49%。美國是我們最大的市場，由於預訂需求強勁成長，其成長了 60%，我們稍後會討論。此外，Tevimbra 於本季在美國獲準用於治療第一線 ESCC。

China says grew by 26% compared to the prior year period. With Tevimbra and Brukinsa are sustaining their market leadership positions. Tevimbra expanded NIDA coverage in frontline gastric and the frontline small cell lung cancer, and imaging collaboration products also continued this strong momentum in the first quarter.

中國表示，與去年同期相比成長了26%。Tevimbra 和 Brukinsa 繼續保持其市場領導地位。Tevimbra 擴大了 NIDA 在一線胃癌和一線小細胞肺癌方面的覆蓋範圍，影像協作產品在第一季也延續了這一強勁勢頭。

Europe experienced the 75% growth as we continue our launch for Brukinsa and Tevimbra. We received the reimbursement for Tevimbra in Spain and early this week, Europe EU approval for Tevimbra in front line extensive stage of small cell lung cancer. We're encouraged by the growth perspective of the region for 2025.

隨著我們繼續推出 Brukinsa 和 Tevimbra，歐洲實現了 75% 的成長。我們在西班牙獲得了 Tevimbra 的報銷，本週早些時候，歐盟批准 Tevimbra 用於治療小細胞肺癌廣泛期一線治療。我們對該地區2025年的成長前景感到鼓舞。

Rest of the world says totaled $32 million in the first quarter, growing 146% compared to the prior year. This was primarily driven by expansion and the new launches in [SEC], Latin, [Mina] regions, including notable progress in South Korea, Japan, Mexico, and Brazil.

世界其他地區第一季總額達 3,200 萬美元，比上年增長 146%。這主要得益於[SEC]、拉丁語、[Mina]地區的擴張和新產品的推出，包括在韓國、日本、墨西哥和巴西取得的顯著進展。

While we're still in the early stage of commercialization in our rest of the world market, we expect them to be strong, consistent contributor of future revenue growth and have us realize our mission to reach many more patients with improved access and affordability.

雖然我們在世界其他市場的商業化仍處於早期階段，但我們希望它們成為未來收入成長的強勁、持續的貢獻者，並讓我們實現我們的使命，讓更多的患者獲得更好的治療機會和負擔得起的醫療服務。

I will now pass the presentation over to Matt to provide the US commercial update.

現在我將把演講交給馬特，讓他提供美國商業的最新情況。

Thanks, Doctor Wu.

謝謝吳醫生。

Moving to Brukinsa's US performance. Q1 US Brukinsa sales reached 563 million, representing growth of 60% versus the prior year, and establishing Brukinsa as the market leader by revenue in the large and growing US BTK market, which grew 11% year over year. This is an important milestone that was reached just two years after our CLL launch. And while this strong performance underscores Brukinsa's continued momentum, the Q1 revenue reflects the typical seasonality seen across all products in the BTK class, as previously discussed on the Q4 update.

轉向布魯金薩在美國的表演。第一季美國 Brukinsa 銷售額達到 5.63 億美元，比上年增長 60%，並使 Brukinsa 成為龐大且不斷增長的美國 BTK 市場中的市場領導者，該市場同比增長 11%。這是我們在 CLL 推出僅兩年後就達到的一個重要里程碑。雖然這一強勁表現凸顯了 Brukinsa 持續的發展勢頭，但第一季的收入反映了 BTK 類別所有產品的典型季節性，正如先前在第四季度更新中所討論的那樣。

Brukinsa's Q1 net revenue and net revenue growth was driven primarily by strong underlying demand, as you can see on this slide. Year over year demand growth was 54% when compared to the first quarter of 2024 and 6% sequentially when compared to the fourth quarter. This steady trend of demand growth reflects our leadership in terms of new patient starts, where we are the lead across all lines of therapy and indications, including both frontline and relapse refractory CLL.

正如您在這張投影片上看到的，Brukinsa 第一季淨收入和淨收入成長主要受到強勁潛在需求的推動。與 2024 年第一季相比，需求年增 54%，與第四季相比，需求年增 6%。這種穩定的需求成長趨勢反映了我們在新患者開始治療方面的領導地位，我們在所有治療領域和適應症方面都處於領先地位，包括第一線治療和復發難治性慢性淋巴細胞白血病 (CLL)。

This momentum, combined with the growing base of existing patients, underscores a solid foundation for ongoing growth. We're confident in the underlying business fundamentals and well positioned for strong performance in the second quarter and the rest of 2025.

這一勢頭，加上現有患者群體的不斷增長，為持續增長奠定了堅實的基礎。我們對潛在的業務基本面充滿信心，並為第二季和 2025 年剩餘時間內的強勁表現做好了準備。

Significant growth opportunities remain within the frontline CLL market, where treatment success requires deep responses, impressive and sustained PFS, and a strong safety profile, all areas in which Brukinsa has consistently demonstrated proven advantages.

第一線 CLL 市場仍然存在巨大的成長機會，該市場的治療成功需要深度反應、令人印象深刻且持續的 PFS 以及強大的安全性，而 Brukinsa 在所有這些領域都始終表現出公認的優勢。

Nearly half of all newly diagnosed CLL patients have one or more high risk features, including unmutated IGHV, deletion 11q, and TP53 deletion 17p, and even more have high risk comorbidities such as Afib. In this population, other BTK inhibitors and current fixed duration treatments are associated with poor outcomes.

幾乎一半的新診斷 CLL 患者俱有一個或多個高風險特徵，包括未突變的 IGHV、缺失 11q 和 TP53 缺失 17p，甚至更多患者俱有心房顫動等高風險合併症。對於這一人群，其他 BTK 抑制劑和目前的固定療程治療均與不良結果相關。

In the ALPINE trial, Brukinsa became the only BTK to demonstrate superiority over ibrutinib in a head to head trial. And in the high risk TP53 deletion 17p population subset of ALPINE, Brukinsa's PFS at 42.5 months median follow-up was 59% versus ibrutinib's PFS of 32%, an impressive 27% higher.

在 ALPINE 試驗中，Brukinsa 成為唯一在頭對頭試驗中表現出優於 ibrutinib 的 BTK。在 ALPINE 的高風險 TP53 缺失 17p 人群子集中，Brukinsa 在 42.5 個月的中位追蹤時的 PFS 為 59%，而 ibrutinib 的 PFS 為 32%，高出 27%。

Brukinsa is the best in class option for all patients, regardless of mutation or significant comorbidities. Given the challenges with current fixed duration regimens and Brukinsa's best in class profile, we see additional opportunity for Brukinsa monotherapy to continue to take market share from these treatment options.

無論是否存在突變或嚴重的合併症，Brukinsa 都是所有患者的最佳選擇。鑑於目前固定療程方案面臨的挑戰以及 Brukinsa 的一流特性，我們認為 Brukinsa 單一療法有更多機會繼續從這些治療方案中搶佔市場份額。

And beyond expansion of BTK monotherapy, we believe that Brukinsa plus Sonro has the opportunity to deliver on the promise of fixed duration and expand its role in the treatment paradigm. Similarly, our BTK CDAC has the potential to surpass the other existing treatment options and fulfill the unmet needs of patients with CLL.

除了擴展 BTK 單一療法之外，我們相信 Brukinsa 加 Sonro 有機會兌現固定持續時間的承諾並擴大其在治療範式中的作用。同樣，我們的 BTK CDAC 有可能超越其他現有的治療方案，滿足 CLL 患者未滿足的需求。

On that note, now over to you, Lai.

關於這一點，現在輪到你了，賴。

Thanks, Matt. I would like to take a few minutes to highlight the key aspects of our portfolio, starting with our hematology franchise.

謝謝，馬特。我想花幾分鐘時間重點介紹我們產品組合的關鍵方面，首先是我們的血液學特許經營權。

Our CL franchise is evolving quickly. We're relentlessly pursuing the best in class treatment options from frontline to late ones, including both continuous and the fixed duration treatments. We believe that to advance the standard care, the fundamental question of whether a potential medicine is better than the existing best treatment options must be answered.

我們的 CL 特許經營權正在快速發展。我們堅持不懈地追求從前線到後期的最佳治療方案，包括持續治療和固定持續時間的治療。我們認為，要推進標準治療，必須回答潛在藥物是否優於現有最佳治療方案這一根本問題。

The clinical trial needs to be designed accordingly. You can see this in our past trials, including ALPINE and our current phase three trials for Sonro and our BTK-CDAC which I will review today.

臨床試驗需要進行相應的設計。您可以在我們過去的試驗中看到這一點，包括 ALPINE 和我們目前針對 Sonro 和 BTK-CDAC 的第三階段試驗，我今天將對其進行回顧。

Brukinsa was designed from inception to provide 24/7 inhibition of BTK in more disease relevant compartments and to address efficacy challenges of ibrutinib. This led to a phase three victory over ibrutinib in a direct comparison last factory CLL. Furthermore, it's enhances selectivity has resulted in improved tolerability in clinical settings.

Brukinsa 的設計初衷是為更多與疾病相關的區域提供全天候 BTK 抑制，並解決 ibrutinib 的療效挑戰。這導致在上一期 CLL 的直接比較中，第三階段擊敗了依魯替尼。此外，其增強的選擇性也提高了臨床環境中的耐受性。

Similarly, Sonro exhibits higher potency and the selectivity compared to the class, offering potential advantages in efficacy and the safety as supported by clinical data. With a short half-life and no drug accumulation, Sonro may allow for more patient-friendly TLS monitoring, which would serve as a key differentiator for venetoclax. We believe that the vast majority of CLL patients will require only one single hospital visit for Sonor ramp up of the Zanubrutinib.

同樣，與同類藥物相比，Sonro 表現出更高的效力和選擇性，臨床數據支持其在療效和安全性方面具有潛在優勢。由於半衰期短且沒有藥物蓄積，Sonro 可以實現更方便患者的 TLS 監測，這將成為 venetoclax 的關鍵區別因素。我們相信，絕大多數 CLL 患者僅需要一次醫院就診即可獲得 Zanubrutinib 的 Sonor 劑量增加。

Our BTK-CDAC is the most advanced BTK degraded contain in the clinic. With precorneal properties indicating safety and efficacy benefits for patients. It's novel mechanism action offers distinct advantages over traditional inhibitors by overcoming and preventing the emerging resistant mutations and disrupting skillful functions.

我們的BTK-CDAC是臨床上最先進的BTK降解載體。具有角膜前特性，顯示對患者俱有安全性和有效性益處。其新穎的作用機制透過克服和防止新出現的抗性突變和破壞熟練的功能，比傳統抑制劑具有明顯的優勢。

Next, I would like to discuss the fixed duration treatment landscape and its significance in enhancing our leadership in CLL. To establish a compelling fixed duration therapy, you must achieve higher efficacy and safety standards. In terms of efficacy, it must deliver extended PFS allowing patients to experience a general drug quality. This requires deep responses, enabling doctors to feel confident that the risk of relapse is minimum when discontinuing therapy, which is measured by undetectable uMRD.

接下來，我想討論一下固定期限治療的前景及其對增強我們在 CLL 領域的領導地位的意義。要建立令人信服的固定持續時間療法，您必須實現更高的功效和安全標準。在療效方面，它必須提供延長的 PFS，讓患者體驗到一般的藥物品質。這需要深度反應，使醫生能夠確信在停止治療時復發的風險最小，這是透過無法檢測到的 uMRD 來衡量的。

Furthermore, it should not present any additional clinical meaning for safety concerns during the treatment period. All potential vaccine class fix duration combination of Zanu with Sonro has demonstrated deep MRD rate, impressive and the sustained PFS and the acceptable safety profiles.

此外，它不應該對治療期間的安全問題產生任何額外的臨床意義。Zanu 與 Sonro 的所有潛在疫苗類別固定持續時間組合均已證明具有深 MRD 率、令人印象深刻且持續的 PFS 和可接受的安全性。

We're progressing rapidly with the development of this fixed duration combination therapy. In line with our standard practice, the slide show 301 trial was designed to demonstrate the PFS security of S plus Z over the current best standard care in fixed duration treatment VO in treatment naive CLL.

我們在開發這種固定療程聯合療法方面正在取得快速進展。按照我們的標準實踐，幻燈片放映 301 試驗旨在證明在初治 CLL 中，S 加 Z 在固定療程治療 VO 中相對於當前最佳標準治療的 PFS 安全性。

This trial complete enrollment in February within just 14 months, marking a significant milestone for the Sonro program and the showcasing strong interest from patients and clinicians and our clinical execution capabilities.

該試驗在短短 14 個月內於 2 月完成招募，標誌著 Sonro 計劃的一個重要里程碑，並展示了患者和臨床醫生的濃厚興趣以及我們的臨床執行能力。

In addition to treatment naive CLL, we're also advancing the development so for relaxed factory cell patients through our special 303 study, which combined Sonro with CD20. This is a true head to head trial designed to demonstrate the superiority of Sonro over venetoclax

除了初治 CLL 外，我們還透過特殊的 303 研究（將 Sonro 與 CD20 結合）來推進針對輕鬆工廠細胞患者的開發。這是一次真正的面對面試驗，旨在證明 Sonro 優於 venetoclax

For mental cell lymphoma, a phase three trial has been initiated to evaluate the treatment effects of two years of Sonro combined with continuous Zanu in relax factory cell. This trial will also serve as confirming trial for Celestial 302, a single phase two study of Sonro monotherapy in relatial fracture mental cell lymphoma post BTKi which we plan to file globally for accel approval in the second half of this year if the results are positive.

對於骨髓淋巴瘤，已啟動三期臨床試驗，評估兩年 Sonro 合併持續性 Zanu 療法的治療效果。該試驗也將作為 Celestial 302 的確認試驗，Celestial 302 是 BTKi 後骨骨折腦細胞淋巴瘤 Sonro 單一療法的單獨二期研究，如果結果為陽性，我們計劃在今年下半年在全球範圍內提交加速批准。

Moving on to our BTK CDAC, we presented the compelling early efficacy and the safety data in a heavily pre-treated population the ASH. As you can see here on this slide. The evolution of our data together with strong KO feedback, gave us confidence to initiate a head to head phase three study against the Pirtobrutinib.

繼續討論我們的 BTK CDAC，我們展示了在大量接受過預先治療的 ASH 族群中令人信服的早期療效和安全性數據。正如您在這張投影片上看到的。我們數據的演變以及強有力的 KO 回饋使我們有信心啟動針對 Pirtobrutinib 的第三階段正面交鋒研究。

The detail of the chart design is showing this slide. The first patient is expected to be enrolled in the second half of this year. We have met with FDA and obtained agreement on our dose for phase three in CLL. I'm very excited to announce that our first phase three study for the BTK CDAC cadence 302 versus physician's choice in the last factory CLL patients had the first patient in this week.

圖表設計的細節顯示在這張投影片上。預計今年下半年入組第一位患者。我們已經與 FDA 會面並就 CLL 第三階段的劑量達成一致。我很高興地宣布，我們針對 BTK CDAC 節奏 302 與醫生選擇的最後一家工廠 CLL 患者進行的第一階段第三研究本周迎來了第一位患者。

We have also started a multi cohort platform study to combine BTK CDAC with internal and external assets like Sonro, Zanu, and the CD20 by specifics. These combinations have the potential to expand the treatment options for patients with B cell malignancies.

我們還啟動了一項多群組平台研究，將 BTK CDAC 與 Sonro、Zanu 和 CD20 等內部和外部資產具體結合起來。這些組合有可能擴大 B 細胞惡性腫瘤患者的治療選擇。

Our solid tumor portfolio has evolved over the last two years with 19 new molecules in the clinic across three major tumor types: lung, breast, gynecological cancers, and GI cancers. We have refined our portfolio to focus on targeted therapy, utilizing various modalities, including ADCs, degraders, and the multi-specifics to deliver highly advocacious treatments for our patients. Our commitment to industry leading speed is evidenced by our fast to park strategy, which continued to drive the rapid development of these molecules.

過去兩年來，我們的實體腫瘤產品組合不斷發展，臨床中已有 19 種新分子用於治療三大腫瘤類型：肺癌、乳癌、婦科癌症和胃腸道癌症。我們改進了我們的產品組合，專注於標靶治療，利用各種方式，包括 ADC、降解劑和多特異性，為我們的患者提供高度倡導的治療。我們致力於保持行業領先速度，這體現在我們的快速停車策略上，該策略持續推動這些分子的快速發展。

I'd like to highlight several key pipeline value inflection points. During the presentation, I addressed some of our significant late-stage milestones. In addition, we had a successful phase to read out Sonro in relax refreshes CLL and achieved the expedited NDA submission in China, completing the process in an impressive 11 weeks from the data cut-off to the NDA acceptance.

我想強調幾個關鍵的管道價值轉折點。在演講過程中，我談到了我們一些重要的後期里程碑。此外，我們成功地在 Relax Refreshes CLL 中讀出了 Sonro，並在中國實現了快速 NDA 提交，從數據截止到 NDA 接受，僅用了令人印象深刻的 11 週時間就完成了整個過程。

We anticipate our global filing last fracture mental cell lymphoma in the second half of this year. Additional phase three pivotal charts for both Sonro and our BTK CDAC will be initiated later this year.

我們預計今年下半年將在全球提交最後一例骨折腦細胞淋巴瘤的申請。Sonro 和我們的 BTK CDAC 的附加第三階段關鍵圖表將於今年稍後啟動。

Turning to our early stage pipeline, we have several POC catalysts expected throughout the year. We'll provide more details regarding our innovative scientific advancements and the portfolio progression during our R&D day on June 26.

談到我們的早期階段產品線，我們預計全年將有幾種 POC 催化劑。我們將在 6 月 26 日的研發日上提供有關我們的創新科學進步和產品組合進展的更多詳細資訊。

With that, I'd like to pass it over to Aaron.

說完這些，我想把它交給 Aaron。

Thanks a lot.

多謝。

We had a strong start to the year with first quarter 2025 revenue of 1.1 billion compared to 752 million in Q1 2024. Revenue growth was 49%, with meaningful contributions across all of our key brands. These top line results are consistent with our communicated guidance expectations and set us up well for the balance of 2025.

我們今年開局強勁，2025 年第一季的營收為 11 億，而 2024 年第一季的營收為 7.52 億。營收成長了 49%，我們所有主要品牌都做出了有意義的貢獻。這些頂線結果與我們傳達的指導預期一致，並為我們 2025 年的平衡做好了準備。

This quarter demonstrates our dual mandate in action. As we are driving significant top line growth with material operating leverage to support long-term business sustainability. As a result of this focus, we delivered positive GAAP operating profit and net income for the quarter. You can see the year over year improvement in GAAP and non-GAAP operating profit measures of 272 million and 286 million respectively.

本季體現了我們的雙重使命。由於我們利用實質的經營槓桿推動顯著的營收成長，以支持長期業務永續性。由於這一重點，我們本季實現了正的 GAAP 營業利潤和淨收入。您可以看到 GAAP 和非 GAAP 營業利潤指標同比分別增長了 2.72 億和 2.86 億。

And as a result of our value-focused investment philosophy, we achieved a third consecutive quarter of positive operating cash flow. This is notable as the first quarter has a seasonally high use of working capital. When looking at our operating cash generation performance compared to Q1 2024, we improved by 353 million.

由於我們以價值為中心的投資理念，我們連續第三個季度實現了正的經營現金流。值得注意的是，第一季是營運資金使用率較高的季度。與 2024 年第一季相比，我們的經營現金產生表現提高了 3.53 億。

Sales of Brukinsa total 792 million in Q1, representing 62% growth as compared to Q1 2024. Growth continues to be primarily driven by demand from our leading new patient share in the United States, coupled with year over year increased volume following a full year of use from patients who began treatment in 2024. This is layered on top of the stable base of patients who remain on therapy from prior years given Brukinsa's long duration of therapy. Growth contributions were seen across all geographies, including Europe, China, and rest of world markets.

Brukinsa 第一季的銷售額總計 7.92 億，與 2024 年第一季相比成長了 62%。成長的主要動力仍然來自我們在美國領先的新患者份額的需求，加上 2024 年開始治療的患者使用整整一年後銷量的同比增長。由於 Brukinsa 的治療持續時間較長，因此這是建立在前幾年仍在接受治療的穩定患者基礎之上的。所有地區均出現了成長貢獻，包括歐洲、中國和世界其他市場。

Tevimbra's sales of 171 million resulted in 18% revenue growth when compared to Q1 2024, driven primarily by our leading market position in China. We're in the early stages of our commercial expansion in other markets. Amgen in-licensed products were key contributors to performance, coming in at 114 million and grew 58% year over year. And finally, we are also seeing year over year growth contribution from collaboration revenue, given our global royalties from [Deltri].

Tevimbra 的銷售額為 1.71 億，與 2024 年第一季相比，營收成長了 18%，這主要得益於我們在中國領先的市場地位。我們正處於其他市場商業擴張的早期階段。安進授權產品是業績的主要貢獻者，銷售額達 1.14 億美元，年增 58%。最後，我們也看到合作收入的貢獻年增，因為我們的全球版稅來自[德爾特里]。

Now, moving to the GAAP income statement. Product gross margin increased nearly 2% points to 85% this quarter compared to 83% in Q1 2024. This was largely due to favorable mix and cost of sales productivity for both Tevimbra and Brukinsa.

現在，轉到 GAAP 損益表。本季產品毛利率較 2024 年第一季的 83% 上升近 2 個百分點，達到 85%。這主要是因為 Tevimbra 和 Brukinsa 擁有良好的產品組合和銷售成本生產力。

Operating expenses totaled 941 million, representing growth of 6% as compared to Q1 2024. Growth was seen in both SG&A and R&D as we continue to invest with discipline to support our commercial businesses and our robust pipeline.

營業費用總計 9.41 億，與 2024 年第一季相比成長 6%。由於我們繼續嚴格投資以支持我們的商業業務和強大的產品線，銷售、一般及行政開支和研發費用均實現了成長。

Note that Q1 2024 included 35 million of business development expenses, which should be considered when interpreting the period over period change. Taken together, our focus on top line growth with meaningful operating leverage led to our achievement of GAAP profitability for the quarter.

請注意，2024 年第一季包括 3,500 萬美元的業務發展費用，在解釋同期變化時應考慮到這一點。總的來說，我們專注於營收成長和有意義的營運槓桿，這使得我們本季實現了 GAAP 利潤。

Our non-GAAP P&L includes adjustments for typical items with a full reconciliation provided in the appendix. Focusing on the bottom line, non-GAAP net income totaled 136 million in Q1 2025, an increase of 282 million versus prior year. This equates to non-GAAP earnings of $1.22 per ADS.

我們的非公認會計準則損益表包括典型項目的調整，並在附錄中提供了完整的對帳。重點關注底線，2025 年第一季非 GAAP 淨收入總計 1.36 億美元，較前一年增加 2.82 億美元。這相當於非公認會計準則每股 ADS 收益 1.22 美元。

Switching to guidance, our full year 2025 guidance remains unchanged. We project revenue to be between 4.9 billion to 5.3 billion. Movement in exchange rates, while volatile at the start of 2025, have largely offset and current rates are contemplated in this affirmed range.

轉向指導，我們對 2025 年全年的指導保持不變。我們預計收入將在 49 億至 53 億之間。匯率變動雖然在 2025 年初出現波動，但已基本抵消，預計當前匯率將處於此確認的範圍內。

Our GAAP gross margin percentage is projected to be in the mid 80% percentile range, benefiting from mix and production efficiencies. Operating expenses on a GAAP basis are anticipated to be between 4.1 billion and 4.4 billion. Non-GAAP operating expenses are expected to track with our GAAP guidance, with reconciling items remaining unchanged from existing practice.

受益於產品組合和生產效率，我們的 GAAP 毛利率預計達到 80% 左右。根據 GAAP 計算，預計營運費用將在 41 億美元至 44 億美元之間。非公認會計準則營運費用預計將與我們的公認會計準則指引保持一致，調節項目與現有做法保持不變。

As we have demonstrated in the first quarter of 2025, we are committed to achieving full year GAAP operating income break even and generating positive cash flow from operations for the full year. Recognizing uncertainty remains, our guidance includes our estimates of the impacts of announced tariffs to our 2025 results. We do not expect a tariff impact associated with our partnered products.

正如我們在 2025 年第一季所展示的那樣，我們致力於實現全年 GAAP 營業收入收支平衡，並在全年產生正的經營現金流。認識到仍然存在不確定性，我們的指導包括對宣布的關稅對 2025 年業績的影響的估計。我們預計我們的合作產品不會受到關稅影響。

Our exposure has been mitigated by our significant investments and partnerships to build a truly global production network, including our commitment to manufacturing in the United States for US supply of billion to Tevimbra and the commercialization of our pipeline assets. This includes our 42 acre Hopewell, New Jersey campus, which is currently being qualified for biological production and could be expanded to other modalities as needed to support our advancing pipeline.

我們透過大量投資和合作建立了一個真正的全球生產網絡，從而降低了我們的風險敞口，包括我們承諾在美國製造，以便美國向 Tevimbra 供應數十億美元，並將我們的管道資產商業化。這包括我們位於新澤西州霍普韋爾佔地 42 英畝的園區，該園區目前正在獲得生物生產資格，並可根據需要擴展到其他模式，以支持我們不斷推進的管道建設。

We will continue to take action to build supply chain resiliency to ensure patients around the world have uninterrupted access to our critically important life-saving medicines.

我們將繼續採取行動，增強供應鏈的彈性，確保世界各地的患者能夠不間斷地獲得我們至關重要的救命藥物。

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

說完這些，我就把電話轉回給丹。

Thanks, Aaron. We are now ready for Q&A.

謝謝，亞倫。我們現在準備好進行問答。

I asked participants to limit themselves to one or two questions to ensure we have time to hear from as many attendees as possible. Operator, we are ready for the first question.

我要求參與者只提出一兩個問題，以確保我們有時間聽取盡可能多的與會者的意見。接線員，我們已經準備好回答第一個問題了。

Thank you. (Operator Instructions).

謝謝。（操作員指令）。

Our first question comes from Andrew Berens at Leerink Partners. Please mute your line and ask your question.

我們的第一個問題來自 Leerink Partners 的 Andrew Berens。請靜音並提出您的問題。

Hi, thanks and congrats on all the progress. Got a question on the CDK4 program. Can you just remind us how 43,395 differs from size of a Termo and I know it's early, but where do you see the CDK4 agents being used in HR positive breast cancer in terms of lines of therapy and potential combination partners? And then maybe another question on Brukinsa, just wondering if you have any appetite to develop the drug beyond oncology. Do you think there's a potential role in autoimmune diseases, and is this something that you would consider doing yourself or with a partner potentially?

你好，感謝並祝賀你取得的所有進展。對 CDK4 程序有疑問。您能否提醒我們 43,395 與 Termo 的尺寸有何不同？我知道現在還為時過早，但就治療路線和潛在組合方案而言，您認為 CDK4 藥物在 HR 陽性乳癌中的應用如何？然後也許還有關於 Brukinsa 的另一個問題，只是想知道您是否有興趣開發腫瘤學以外的藥物。您是否認為它在自體免疫疾病中具有潛在作用？您是否會考慮自己或與伴侶一起做這件事？

Yeah, thanks for the question. For the CDK4, our molecule was designed, benchmarking against the fighters of thermal cyclic to be more potent as well as more selective. Right now, we're still in the process of those escalation. We're actually moving this program very aggressively, even in the, just the last one month or so, we have enrolled. The last couple of months, we have enrolled over 100 patients. We still plan to move this forward into the phase three trials aggressively. The current thinking around this molecule is to initiating a phase three trials in the second line settings in combination with trials .

是的，謝謝你的提問。對於 CDK4，我們的分子設計以熱循環戰鬥機為基準，使其更有效、更具選擇性。目前，我們仍處於事態升級的過程中。我們實際上正在非常積極地推進這個項目，甚至就在過去的一個月左右，我們才剛開始招生。過去幾個月，我們已經招募了 100 多名患者。我們仍計劃積極推進第三階段試驗。目前圍繞該分子的想法是啟動二線治療的第三階段試驗，並結合其他試驗。

So that's the plan. And in addition to that, we're also contemplating the play in the earlier lines. As for your question relates to the Brukinsa outside of the oncology, we have a phase three ongoing, which is in the membranous nephropathy, which is the fourth point you mentioned about in the II indication.

這就是計劃。除此之外，我們還在考慮之前的劇情。至於您的問題涉及腫瘤學之外的 Brukinsa，我們正在進行第三階段研究，研究的是膜性腎病，這是您在 II 適應症中提到的第四點。

Okay, thank you. And do you have an [oral soil] in your portfolio that has been disclosed?

好的，謝謝。您的投資組合中是否有已揭露的[口腔土壤]？

We do not have [oral soil].

我們沒有【口土】

Okay, thank you.

好的，謝謝。

Our next question comes from Yaron Werber at Cowen and Company. Please go mute your line and ask your question.

我們的下一個問題來自 Cowen and Company 的 Yaron Werber。請靜音並提出您的問題。

Great, thanks so much and congrats on a lot of pipeline progress. Maybe for Matt or Aaron, any, can you give us a sense for Brukinsa in Q1, any sense how much was the weakness in the class related to the party redesign. And then for Tevimbra, is there any way you can split out sales in the US, Europe, sort of rest of the world and China? Thank you.

太好了，非常感謝，並祝賀管道取得了很大的進展。也許對 Matt 或 Aaron 來說，您能否讓我們了解 Q1 中的 Brukinsa，了解班級的弱點與派對重新設計有多大關係。那麼對於 Tevimbra，有什麼方法可以劃分美國、歐洲、世界其他地區和中國的銷售嗎？謝謝。

Do you want to go ahead and, sure.

你想繼續嗎？當然可以。

Sure, this is Aaron. Thanks for the question you're in. I mean, I would start, without speaking to the broader industry. Obviously, Part D resigned to some has some impact, as it relates to pricing, we've talked about a relatively stable net pricing environment for our company. This is coming from a couple of factors, of course, with the redesign. As we look at our business, we do see some Q1 favorability driven by the redesign in part as a result of the elimination of the manufacturer liability for the coverage gap. That would largely be experienced earlier in the year, as patients worked through the donut hole, and then obviously, manufacturers had the liability associated with that coverage gap.

當然，這是亞倫。感謝您的提問。我的意思是，我先從更廣大的產業角度來談。顯然，D 部分的辭職對某些人來說有一些影響，因為它與定價有關，我們已經討論了我們公司相對穩定的淨定價環境。當然，這是由重新設計導致的幾個因素造成的。當我們審視我們的業務時，我們確實看到了一些由重新設計推動的第一季有利因素，部分原因是消除了製造商對覆蓋範圍差距的責任。這在很大程度上會在今年稍早出現，因為患者正在努力解決這個難題，顯然，製造商要承擔與該覆蓋範圍差距相關的責任。

For us, with the redesign, we do benefit, as we've spoken about, from the specified small manufacturer designation, which layers in our manufacturer liability, over a five-year period. So, on balance, as you think about Q1, you get a little bit of favorability given the lapping of the pricing in the base from 2024. And that's offset to a degree by the manufacturer liability on the Part D's redesigned for us, which will, be consistent over the balance of this. Year. So, other than that, Matt, anything you have?

對我們來說，透過重新設計，正如我們所說的，我們確實受益於指定的小型製造商稱號，該稱號在五年內賦予了我們製造商的責任。因此，總的來說，當您考慮第一季時，考慮到從 2024 年開始定價的重疊，您會獲得一點好處。這在一定程度上被為我們重新設計的 D 部分的製造商責任所抵消，這將與此平衡保持一致。年。那麼，除此之外，馬特，你還有什麼嗎？

Maybe I'll just add a little bit of commentary about Q1, related to seasonality. I think that kind of goes hand in hand with the Medicare Part D's. And then I'll gladly, address the US Tevimbra component of the question as well, and, we talked about some things back in the fourth quarter. Related to what we anticipated in Q1 on seasonality. There's a typical, customer inventory build in the fourth quarter with a drawdown that we then see in the first quarter. We disclose about a $30 million buy-in, and then we also have noted one less shipping week in Sparks, Florida this year than for other typical quarters.

也許我只想添加一些與季節性相關的有關 Q1 的評論。我認為這與醫療保險 D 部分是相輔相成的。然後我很樂意回答有關美國 Tevimbra 的問題，我們在第四季度討論過一些事情。與我們對第一季季節性的預期有關。典型的情況是，客戶庫存在第四季度增加，然後在第一季減少。我們披露了約 3000 萬美元的買入價，同時我們也注意到，今年佛羅裡達州斯帕克斯的航運週數比其他典型季度少了一周。

So, really in the first quarter, we typically see a slight drop in new starts due to changes in patients' insurance, and out of pocket resets and other factors. So this first quarter was really no different than that.

因此，在第一季度，我們通常會看到由於患者保險變化、自付費用重置和其他因素導致的新開診所數量略有下降。因此，今年第一季與此並沒有什麼不同。

On the Tevimbra US piece, we don't report, separate breakouts for that, but we're very encouraged with the progress that's been made on Tevimbra in the US. We were very pleased to receive our frontline esophageal approval, that was our third approval in the US within a year, coming after second line esophageal and frontline gastric. And of course, we were also very pleased to see listing in the NCCN guidelines, and also more recently, our alternative dosing Q2W and Q4W came in line as well.

關於 Tevimbra 在美國的情況，我們沒有單獨報道，但我們對 Tevimbra 在美國的進展感到非常鼓舞。我們非常高興獲得一線食道癌批准，這是我們一年內在美國獲得的第三次批准，繼二線食道癌和第一線胃癌之後。當然，我們也很高興看到它被列入 NCCN 指南中，而且最近，我們的替代劑量 Q2W 和 Q4W 也符合要求。

So, what we now see is initial experiences, patience starts, all in line with launch expectations, and we'll see the second quarter really be the starting point for Tevimbra in the US now that all those other factors have come into line.

因此，我們現在看到的是初步體驗、耐心開始，一切都符合發布預期，現在所有其他因素都已就位，我們將看到第二季度真正成為 Tevimbra 在美國的起點。

And if I could just maybe just follow up on Brukinsa, the cigarette approval now in EMA, for EMA from Switzerland is a big deal. How much inventory can they do? Can they supply the US market as well, or is there a chance that they'll have capacity to, or it sounds like you're talking to another manufacturer for the US, any update there?

如果我可以跟進 Brukinsa 的情況，EMA 現在批准的香菸對於瑞士的 EMA 來說是一件大事。他們能做多少庫存？他們是否也能供應美國市場，或者他們是否有能力供應，或者聽起來您正在與美國的另一家製造商洽談，有什麼最新消息嗎？

Yeah, so thanks for the question. We are pleased with our approval for our second source of API from our Swiss supplier, as you mentioned, and we are working to continue to broaden out our supply chain resiliency with securing sourcing from another supplier in Spain. So that's a portion of our API usage. We've taken assertive action to ensure we have significant stockpiles, both for regular run demand, but as well to have additional security as it relates to our API stockpile. So we're confident in our position in that regard.

是的，謝謝你的提問。正如您所說，我們很高興獲得瑞士供應商的第二個 API 來源批准，並且我們正在努力繼續擴大我們的供應鏈彈性，確保從西班牙的另一家供應商處採購。這就是我們的 API 使用的一部分。我們已採取積極措施，確保擁有大量庫存，不僅滿足常規運行需求，還能為我們的 API 庫存提供額外的安全保障。因此，我們對自己在這方面的地位充滿信心。

Thank you. Our next question comes from Jessica Fye at J.P. Morgan. Please mute your line and ask your question.

謝謝。我們的下一個問題來自摩根大通的傑西卡·費伊 (Jessica Fye)。請靜音並提出您的問題。

Hey guys, good morning. Thanks for taking my question. On the CDK4 program, just to confirm, it's fair to think that FC data could come during your R&D day in late June, and can you maybe set the stage a little bit for what kind of data you'll share, i.e. Is there going to be enough follow up to get a look at durability here, or should we mainly be expecting more safety and response rates? And then, also related to that program, can you just remind us where you are in terms of starting or enrolling a CDK 46 naive cohort with that molecule?

大家好，早安。感謝您回答我的問題。關於 CDK4 計劃，只是為了確認一下，可以合理地認為 FC 數據可能會在 6 月底的研發日期間發布，您能否稍微介紹一下您將分享什麼樣的數據，例如，是否會有足夠的後續行動來了解這裡的耐用性，或者我們應該主要期待更多的安全性和響應率？然後，同樣與該計劃相關，您能否提醒我們您在開始或招募具有該分子的 CDK 46 幼稚隊列方面處於什麼階段？

Jessica, thanks for the question. In terms for the data disclosure and on R&D day, we'll be mainly focused on the, those escalation cohorts. We're certainly including the efficacy data in addition to the safe DPK. But, however, as you noticed, this program moved very quickly. Actually, just in the last two months, we enrolled over 100 patients. So the durability side of it, as you can imagine, it will be limited.

傑西卡，謝謝你的提問。就資料揭露和研發日而言，我們將主要關注那些升級群體。除了安全的 DPK 之外，我們當然還包括功效數據。但是，正如您所注意到的，這個計劃進展非常快。實際上，光是在過去兩個月，我們就招募了 100 多名患者。因此，正如您所想像的，它的耐用性是有限的。

In charm for, this molecules, the second part of your question was about, CK 4 CDK 46 naive treatment settings. We actually have enrolled patients already in that settings. So we began to accumulate data in the settings. So we're eagerly waiting for that data to help us to make the decision in the front time.

對於這種分子，你的問題的第二部分是關於 CK 4 CDK 46 幼稚治療設定。實際上，我們已經在該環境中招募了患者。因此我們開始在設定中累積數據。因此，我們熱切地等待這些數據來幫助我們提前做出決定。

And will we see any of that at R&D day?

我們會在研發日看到這些嗎？

It's too early to be disclosed that on R&D day.

在研發日透露這一點還為時過早。

Okay. Thank you.

好的。謝謝。

Our next question comes from Reni Benjamin at Citizens. Please mute your line and ask your question.

我們的下一個問題來自《公民報》的雷尼‧班傑明 (Reni Benjamin)。請靜音並提出您的問題。

Hey, good morning, everyone. Thanks for taking the questions and congratulations on all the progress. As you look at the 10 proof of concept readouts this year, can you maybe highlight, maybe the top ones that you think could really drive your excitement as you move forward. And then separately, the mangrove trial you mentioned has an interim analysis of the phase three trial. Can you just provide an overview and just what your expectations are from that interim analysis. Thanks.

嘿，大家早安。感謝您回答問題，並祝賀您取得的所有進展。當您查看今年的 10 個概念驗證讀數時，您能否重點介紹一下，也許您認為最重要的那些讀數可以在您前進的過程中真正激發您的興奮。然後另外，您提到的紅樹林試驗對第三階段試驗進行了中期分析。您能否提供一個概述以及您對中期分析的期望。謝謝。

Yeah, thanks for the question. I got this question a lot. But where do I start? There's so many really exciting programs, we spread the progress. We actually anticipate the most, molecules enter the clinic last year. We should expect the data this year. I wouldn't say which one is my favorite. I actually like them all. In term for the member of study, it's an event-driven study, so we're waiting, eagerly waiting for the events to happen. . So we hope that's what happened in the second half of this year.

是的，謝謝你的提問。我常被問到這個問題。但我該從哪裡開始呢？有這麼多真正令人興奮的項目，我們傳播了進展。實際上，我們最期待的分子在去年就進入了臨床。我們應該期待今年的數據。我不會說我最喜歡哪一個。我實際上都喜歡它們。對研究成員來說，這是一項事件驅動的研究，所以我們在等待，熱切地等待事件的發生。。所以我們希望今年下半年能夠發生這樣的事情。

Thank you. Our next question comes from Michael Schmidt at Guggenheim Partners. Please unmute your line and ask your question.

謝謝。我們的下一個問題來自古根漢合夥公司的邁克爾·施密特。請取消靜音並提出您的問題。

Hey, good morning. Thanks for taking our questions. I just had a follow up on the first line mental cell lymphoma opportunity for Brukinsa based on mangrove. Could you just help us understand the size of that opportunity and do you plan on submitting regulatory filings based on this interim data here in the second half? And then a question just longer term on the CLL market, how, what is your view on how Brukinsa is positioned longer term with the Pirtobrutinib first line data reading out here later this year from Lili, what gives you confidence and, in Brukinsa's best in class, market position long term and in CLL. Thanks so much.

嘿，早安。感謝您回答我們的問題。我剛剛對基於紅樹林的 Brukinsa 的一線精神細胞淋巴瘤機會進行了跟進。您能否幫助我們了解這個機會的規模？您是否計劃在下半年根據這些中期資料提交監管文件？然後關於 CLL 市場的長期問題，您如何看待 Brukinsa 的長期定位？今年晚些時候，Lili 將公佈 Pirtobrutinib 的一線數據，是什麼讓您對 Brukinsa 的長期市場定位充滿信心？ Brukinsa 是否是同類最佳？在 CLL 市場中長期佔據何種地位。非常感謝。

Yeah, I will probably start, probably asking that to comment on commercial side of it. For the first line of mangrove study, I just want to remind everybody about the study design. This is, we're using a chemo-free regimen which is [arituximab plus] put them. The control arm is BR.

是的，我可能會開始，可能會要求對其商業方面進行評論。對於紅樹林研究的第一線，我只想提醒大家注意研究設計。也就是說，我們正在使用一種無化療方案，即 [阿妥昔單抗加]。控制臂是 BR。

This is a little bit different from the ACO study, which is adding the color on top of BR. We do believe this providing a really probably a preferred option, ultimately, if the trial is successful to the patients, which is chemo-free. So this one thing was to highlight is in the frontline the pieces, the treatment duration will be very long. So if it's successful, it does can further expand our marketing the mental self, but later on ask me to comments how big the market is.

這與 ACO 研究略有不同，ACO 研究是在 BR 之上添加顏色。我們確實相信，如果試驗成功，這最終將為患者提供一種無需化療的首選方案。所以有一點要強調的是，在前線，治療持續時間會很長。所以如果它成功了，它確實可以進一步擴大我們的行銷心理自我，但稍後請我評論一下這個市場有多大。

Moving on to your question around proto side of it, the proto study in the front line is against the that's the first study. The second study was enrolling about 1/3 of patients, which is in the treatment naive, but it's a mixed population also with the second line and the later line. The competitor there is [inaudible]. So, we don't, we do not believe this presents a significant threat to our Brukinsa because the comparator is not the Brukinsa.

繼續回答你關於原型方面的問題，前線的原型研究是反對的，這是第一個研究。第二項研究招募了約 1/3 的患者，這些患者尚未接受過治療，但也是第二線和後期治療的混合族群。那裡的競爭對手是[聽不清楚]。因此，我們不認為這會對我們的 Brukinsa 構成重大威脅，因為比較器不是 Brukinsa。

Yeah, and I'll just briefly, comment on mantle cell and then move over the keto related element of the question. We clearly see a reasonable size opportunity in mantle cell. And in fact, continue to see opportunities for the BTK class in that segment, and also continue to have strong share position there.

是的，我將簡要評論一下套細胞，然後轉到問題中與酮相關的元素。我們清楚地看到了套細胞中合理的尺寸機會。事實上，我們繼續看到 BTK 類在該領域的機會，並且繼續在該領域保持強勁的市場份額。

With regard to, Peo and the future outlook. For the class and for Brukinsa, but we fully expect to continue to maintain and expand market share with our BTK therapy. Based on the peer to readouts recently, we think it's really unlikely to see significant shifts to earlier lines of therapy. We think that we've heard the competitor make similar remarks, regarding sequencing. And, really believe that, continuous BTK therapy is going to continue to be the best option in those earlier lines of therapy. We also see that utilization is in line with that, and that, and the Pyto is really being utilized in those later lines of therapy.

關於Peo和未來展望。對於該類別和 Brukinsa 來說，但我們完全希望透過我們的 BTK 療法繼續保持和擴大市場份額。根據最近的同行讀數，我們認為早期治療方法不太可能發生重大轉變。我們認為我們聽過競爭對手就排序問題發表過類似的言論。並且，我們確實相信，持續 BTK 療法將繼續成為早期療法中的最佳選擇。我們也看到利用率與此相符，而且 Pyto 確實在後期的治療中得到利用。

Thank you.

謝謝。

Our next question comes from Ziyi Chen at Goldman Sachs. Please mute your line and ask your question.

我們的下一個問題來自高盛的陳子怡。請靜音並提出您的問題。

Hey, good morning and thank you for taking my questions. Two questions, one on IRA, and the other one on expenses. So how do you see the potential impact of cos getting into IRA negotiation this year and, with the new price going to be effective in 2027?

嘿，早上好，感謝您回答我的問題。兩個問題，一個關於 IRA，另一個關於費用。那麼，您如何看待今年 cos 加入 IRA 談判以及新價格將於 2027 年生效的潛在影響？

And also for your IRA, what is going to be your best case scenario, in terms of expenses, we actually see, with a major wave of approved concept data coming from the solid tumor pipeline, we believe there are going to be a lot more trials being initiated and a lot more potentially pivotal studies being initiated.

對於您的 IRA，就費用而言，最好的情況是什麼？我們實際上看到，隨著大量來自實體腫瘤管道的核准概念數據，我們相信將會啟動更多的試驗，並啟動更多潛在的關鍵研究。

So how should we see the trend of the R&D spending, in the first quarter is down a little bit quarter to quarter but, do you still have the flexibility and spending given you have the target of profit making in this year potentially beyond 2025. Thank you.

那我們該如何看待研發支出的趨勢呢？第一季的支出較上季略有下降，但考慮到你們的目標是在今年甚至 2025 年以後實現盈利，你們是否仍然具有靈活性和支出能力？謝謝。

Yeah, I guess I'll just start out with IRA and the question related to Calquin's, we won't see Calquin's IRA implications until 2026. We may see some indirect marketplace tide impact, regardless of, that price negotiation status, and we think that that's going to be manageable, obviously with respect to imbruvica. We don't see it as a credible substitute for Brukinsa due to safety and efficacy, particularly given our alpine trial, showing head to head superiority, and also the known cardiac toxicity profile for imbruvica.

是的，我想我會從 IRA 和與 Calquin 相關的問題開始，我們要到 2026 年才能看到 Calquin IRA 的影響。無論價格談判狀態如何，我們都可能會看到一些間接的市場潮流影響，我們認為這將是可控的，顯然對 imbruvica 而言。由於安全性和有效性，我們不認為它是 Brukinsa 的可靠替代品，特別是考慮到我們的高山試驗顯示出頭對頭的優勢，以及已知的 imbruvica 心臟毒性特徵。

We see substantial differentiation there, of course, later, with cal points, we see less cardiac issues than a imbruvica, but also questionable efficacy across multiple studies, and clearly, at best see that as a poor subject too for breast cancer. So we continue to be pleased with our leadership position in new starts and relapse in refractory and in frontline, and are the most prescribed across the B cell malignancies. We think that continued strong market performance will be critical as we head into that, know that IRA time thing.

當然，後來我們看到了顯著的差異，透過計算點，我們發現心臟問題比伊布韋卡要少，但多項研究的療效也值得懷疑，顯然，充其量也將其視為乳癌的一個不良研究對象。因此，我們繼續對我們在新藥治療、復發治療和一線治療領域的領導地位感到滿意，並且是 B 細胞惡性腫瘤中處方最多的藥物。我們認為，在我們邁向這一目標的過程中，持續強勁的市場表現將至關重要，了解 IRA 時間的事情。

Great, thank you. And with respect to our R&D investment, as you see in our 2025 guidance, we are investing significantly, to rapidly advance our pipeline. You did reference our dual mandate of driving, being a growth company, but doing it in a sustainably sustainable way, you see that in our operating results, not just this quarter, but in the preceding quarters as well. So we will continue to operate against that dual mandate of growth with margin expansion, and we're committed to developing the pipeline.

太好了，謝謝。關於我們的研發投資，正如您在我們的 2025 年指導中所看到的，我們正在進行大量投資，以快速推進我們的產品線。您確實提到了我們的雙重使命，即推動公司成長，但要以可持續的方式實現成長，您可以從我們的經營業績中看到這一點，不僅是本季度，而且在前幾個季度也是如此。因此，我們將繼續按照成長和擴大利潤的雙重使命開展工作，並致力於開發產品線。

I think what we've talked about historically is having a strong type, top line with disciplined investment still allows us to invest with growth against that emerging pipeline. And we always speak to the fact that, we have a significant investment already and we have a pipeline that has had a portfolio of late stage investments. You think about Tevimbra, you think about Brukinsa, you think about our TD program, those were significant investments. Those are rolling over and as we, and they're being replaced by our investments in our current late stage pipeline and great opportunities in front of us with Sonro and the degrader, and that provides opportunity also with respect to our early stage program.

我認為，我們過去所談論的是，擁有強大的類型、有紀律的投資的頂線仍然使我們能夠針對新興管道進行成長投資。我們總是說，我們已經有大量投資，我們擁有一系列後期投資組合。你想想 Tevimbra，你想想 Brukinsa，你想想我們的 TD 計劃，這些都是重大投資。這些都在不斷推陳出新，而我們，它們正在被我們對當前後期管道的投資和我們面前的 Sonro 和降解劑的巨大機遇所取代，這也為我們的早期計劃提供了機會。

But we have talked about how BD is in our DNA, we're fortunate to have such a robust pipeline. Lai talked about how many favorites we do have that provides a lot of optionality for us. These are all fully owned assets, so that, we're obviously there's no shortage of interest in our pipeline. We're open to the optionality that affords, but given our strong balance sheet and our capital discipline, we're not obligated to do anything. So we're really in a strong position, as it relates to advancing the pipeline and do it and creating the maximizing value for our shareholders.

但我們已經討論過 BD 如何融入我們的 DNA，我們很幸運擁有如此強大的管道。賴談到了我們有多少喜歡的，這為我們提供了許多選擇。這些都是完全自有的資產，因此，我們顯然對我們的管道不缺乏興趣。我們對可能的選擇持開放態度，但鑑於我們強大的資產負債表和資本紀律，我們沒有義務採取任何行動。因此，我們確實處於有利地位，因為它與推進管道建設有關，並為我們的股東創造最大化價值。

Thank you.

謝謝。

Our next question comes from Kelly Shi at Jefferies. Please unmute your line and ask your question.

我們的下一個問題來自 Jefferies 的 Kelly Shi。請取消靜音並提出您的問題。

Hi, good morning. This is Clara on for Kelly. Thanks for taking our question and congrats on the progress for the quarter. So for the phase two data readout for around the clocks in refractory mental cell lymphoma in the second half of the year and, the BTK CDAC phase two data in 2026. Just wanted to clarify what are the endpoints you and the regulatory agency are looking at to potentially support the registration. And also for the following of surreal clocks in China, can you walk us through what kind of the typical review timeline there. Thank you.

嗨，早安。我是克拉拉，代替凱利。感謝您回答我們的問題，並對本季的進展表示祝賀。因此，對於難治性腦細胞淋巴瘤的第二階段數據讀取將於今年下半年進行，而 BTK CDAC 第二階段數據將於 2026 年進行。只是想澄清一下，您和監管機構正在關注哪些端點以可能支持註冊。另外，對於中國超現實時鐘的關注，您能否向我們介紹那裡典型的評論時間表。謝謝。

Yeah, okay, thanks for the question. For both so as well as BTK CDAC, those are typical, single mono therapy phase two studies. The prime point OR and the DOR, this was of course potential. In term of for the class, the following, we have already received the party review from the CDE that's listed on the CD website. We're anticipating potential approval probably in the first half of next year.

是的，好的，謝謝你的提問。對於 BTK CDAC 和 BTK 而言，這些都是典型的單一療法第二期研究。主要點 OR 和 DOR，這當然是潛在的。就以下課程而言，我們已經收到了 CD 網站上列出的 CDE 的派對評論。我們預計可能在明年上半年獲得批准。

Thank you.

謝謝。

Our next question comes from Gregory Renza at RBC Capital. Please mute your line and ask your question.

我們的下一個問題來自 RBC Capital 的 Gregory Renza。請靜音並提出您的問題。

Great. Hey, good morning, John and team. Congrats on the progress and thanks for taking my questions.

偉大的。嘿，早上好，約翰和團隊。恭喜您的進展，感謝您回答我的問題。

Maybe just on the quest for serial innovation and just around COL and on the BTK CDAC. I'm just curious if you could comment on that relative positioning to, of the CDAC to routine BTKs in the longer term, know one what gives you confidence that 16,673 may have the ability to beat Kurdo in a head to head study. And secondly, certainly with discussion around maybe some risks about using degraders earlier in treatment lines in treatment settings, just curious about, potential mechanism resistance, how that could preclude other treatment options? Just curious on your view with respect to that sequencing. Thanks so much.

也許只是在尋求連續創新，圍繞著 COL 和 BTK CDAC。我只是好奇，您是否可以評論 CDAC 與常規 BTK 的長期相對定位，知道是什麼讓您有信心 16,673 可能有能力在正面交鋒的研究中擊敗 Kurdo。其次，當然，討論在治療環境中早期使用降解劑可能存在一些風險，只是好奇潛在的機制阻力，這會如何排除其他治療選擇？我只是好奇您對該排序的看法。非常感謝。

Yes, thanks for the question. Relate to, our confidence, our BTK degrader. I can tell you what, that's increasing by day. With more data coming, this really give us assurance, this job is doing what it's supposed to do. To truly fully complete degrade BTK protein and also providing the patient sustained clinical benefits. Was with the additional data, coming in and also our feedback from the KOLs really given us confidence to start this head to head trial versus Puro, and, this trial will be initiated in the second half of this year.

是的，謝謝你的提問。與我們的信心、我們的 BTK 降解劑相關。我可以告訴你，這個數字正在日益增加。隨著更多數據的湧現，這確實給了我們信心，這項工作正在做它應該做的事情。真正全面徹底地降解BTK蛋白，並為患者帶來持續的臨床益處。隨著額外數據的湧入以及來自 KOL 的反饋，我們確實有信心開始與 Puro 進行正面交鋒的試驗，並且該試驗將於今年下半年啟動。

In terms of utilizing the BTK degraded in the earlier line, I think that's your second question. We're gaining data on that. We're opening a cohort in the treat BTKI9 patient population to test it out. This is definitely a different MOA versus the traditional BTK inhibitor. It's very early to say, which one is better and what's the right sequence. So we're going to do the scientific experiment to test it out, but it's great to have the option of both. Traditional BDK encryptor as well as a BDK degrader.

關於利用先前線路中降解的 BTK，我認為這是您的第二個問題。我們正在收集有關該問題的數據。我們正在治療 BTKI9 患者群體中開設一個隊列來測試它。與傳統的 BTK 抑制劑相比，這絕對是一種不同的 MOA。現在說哪一個更好以及正確的順序是什麼還為時過早。因此我們將進行科學實驗來測試它，但如果能同時選擇這兩種方法就更好了。傳統的 BDK 加密器以及 BDK 降級器。

In addition to that, I just want to finalize, with the also potentially best in class BCR2, that gives us a lot of different options to play in the space which we think is very important. We really want to provide the best option for patients, not just in the front line, but also in the later ones.

除此之外，我只想最終確定，同樣可能是同類最佳的 BCR2，它為我們提供了多種不同的選擇，我們認為這非常重要。我們確實希望為患者提供最好的選擇，不僅是在前線，而且在後期。

That's great. Thank you very much. And if I may, I have an earlier question on BTK and PNM. I'm just curious how you're thinking about the INI portfolio, certainly with the IA for is that an area that you want to expand upon as you think about internal and even external development? Thanks again guys.

那太棒了。非常感謝。如果可以的話，我之前有一個關於 BTK 和 PNM 的問題。我只是好奇您如何看待 INI 投資組合，當然對於 IA 來說，這是您在考慮內部甚至外部發展時想要擴展的領域嗎？再次感謝大家。

Yes, thanks for that question. I didn't spend time to discuss our III portfolio during the call, and, this is actually very exciting portfolio for BeiGene. We actually have a dozen of the Perent program, which we're developing in II space.

是的，謝謝你的提問。我在電話會議中沒有花時間討論我們的 III 產品組合，而這對百濟神州來說實際上是一個非常令人興奮的產品組合。我們實際上有十幾個 Perent 計劃，我們正在 II 空間進行開發。

Again, we're utilizing our, variety of different modality trying to create the best class molecules as well as potentially first in class molecules relate to the IA 4 inhibitor, IA 4 degrader was super excited about this molecule. So far the early data we have seen with this molecule again, suggesting it has the best in class potential with its PK, with this level of the degradation. We believe we can achieve a complete target declaration at very low dose level and we also is eagerly anticipating our data in the tissue PD which should come in the second half of this year. But well, as I mentioned, we also have other II portfolio which we are really began to developing and hopefully you will see molecules coming from our pipeline in the next couple of years.

再次，我們正在利用各種不同的方式嘗試創造最佳等級的分子以及潛在的與 IA 4 抑制劑、IA 4 降解劑相關的一流分子，我們對這種分子感到非常興奮。到目前為止，我們再次看到的有關這種分子的早期數據表明，在這種降解水平下，它的 PK 具有同類最佳的潛力。我們相信，我們可以在非常低的劑量水平下實現完整的目標宣言，我們也熱切期待今年下半年獲得的組織 PD 數據。但是，正如我所提到的，我們還有其他 II 產品組合，我們真正開始開發這些產品，希望您能在未來幾年內看到來自我們管道的分子。

Thank you. Our next question comes from Sean Laaman at Morgan Stanley and Co. Please unmute your line and ask your question.

謝謝。我們的下一個問題來自摩根士丹利公司的 Sean Laaman。請取消靜音並提出您的問題。

Good morning, everyone. I hope you're all well. Some, a simple benchmarking question to start, if you look at the revenue, reported by Ben Clexter, how would you size the opportunity for Sonrotoclax against that, given potential better safety issues, broadening, improving efficacy and what other combination opportunities there might be.

大家早安。我希望你們都很好。首先要問一個簡單的基準問題，如果您看一下 Ben Clexter 報告的收入，考慮到潛在的更好的安全問題、擴大、提高功效以及可能存在的其他組合機會，您會如何衡量 Sonrotoclax 的機會。

Yeah, thanks for the question. That unlike the BTKi field, there's tons of competition in the B cell to field that truly there's really two molecules. One is (inaudible).

是的，謝謝你的提問。與 BTKi 領域不同，B 細胞領域存在大量競爭，實際上只有兩種分子。一個是（聽不清楚）。

We actually very excited about the portfolio of the profile of our rental carts. It's, much more potent and also more selective. Right now, you were seeing that in the different indication with the response rate, with duration response. This is why it give us the confidence to starting more than just one head to head trial. The first trial we mentioned, which was our special one, we already finished enrollment. This is CS regimen versus VO and we are very excited about the second trial as well, which is in the relax re CR setting to testing strength to class versus the class in the CD20 combination setting, but this is truly head to head.

事實上，我們對我們的租賃車的概況組合感到非常興奮。它的效力更強，選擇性也更強。現在，您看到的是回應率和持續時間回應的不同指示。這就是為什麼它讓我們有信心開始不只一次面對面的試驗。我們提到的第一個試驗是我們的特別試驗，我們已經完成了招生。這是 CS 方案與 VO 的對比，我們對第二次試驗也感到非常興奮，這是在放鬆 CR 設定中測試強度等級與 CD20 組合設定中的等級的對比，但這是真正的正面交鋒。

We believe with those two trials can really establish strength class as the potentially. The vaccine class PCR 2. This is critical. But in addition to that, I just want to mention, we are also exploring the indications which class hasn't really had a success. That's including multiple myeloma. We cannot talk about that trial for a while now, but that trial is moving along very nicely. We're anticipating reporting more data later this year.

我們相信，透過這兩次試驗可以真正確定實力等級的潛力。疫苗類別PCR 2。這很關鍵。但除此之外，我只想提一下，我們還在探索哪些班級沒有真正成功的跡象。其中包括多發性骨髓瘤。我們暫時不能談論該審判，但該審判進展非常順利。我們預計今年稍後將報告更多數據。

I'll hand over to the Matt.

我將把這個任務交給馬特。

Yeah, I can just offer some commentary on the market opportunity, and, we currently see the opportunity for a BCL-2 and a CV20 to be about a quarter of that frontline opportunity in CLL and we've said a number of times that we think that there's really three necessary components for success, and in particular with fixed duration, that's deep response and undetectable MRD long PFS, and strong safety. And more recently, we've seen some of the fixed duration, regiments fail to meet that that high bar. For some of the reasons that lies outlined, we're very confident that there'll be opportunities with Zanu and Sonro to meet that high bar, and then ultimately lead to some expansion of the use of the BCL-2s and CD 20s in that setting. So, that's a possibility, and then clearly we see Zanu and Sonro as being the real driver for expansion in that setting.

是的，我可以對市場機會提供一些評論，我們目前認為 BCL-2 和 CV20 的機會約佔 CLL 一線機會的四分之一，我們已經多次說過，我們認為成功確實有三個必要要素，特別是在固定持續時間的情況下，即深度反應和無法檢測的 MRD 長 PFS，以及強大的安全性。最近，我們發現一些固定期限的軍團未能達到這個高標準。由於上述某些原因，我們非常有信心，ZANU 和 Sonro 將有機會達到這一高標準，並最終擴大 BCL-2 和 CD 20 在該環境中的使用。所以，這是一種可能性，然後我們清楚地看到 Zanu 和 Sonro 是在這種環境下擴張的真正推動力。

Thank you. And one more quick one if I may, I'm more on the commercial side, but, historically, when you do benchmarking against Brukinsa of revenue against peers, across Europe, you seem, sort of underweight, if you like. But I'm just wondering if you, there's good momentum it appears in this quarter. Do you think you've got the investment about right in terms of sales people to really grow that European revenue or you just sort of map that map that out for me a little bit would be awesome.

謝謝。如果可以的話，我再快速問一句，我更側重於商業方面，但是從歷史上看，當你將布魯金薩的收入與歐洲同行進行比較時，如果你願意的話，你似乎有點低估了。但我只是想知道，本季是否出現了良好的勢頭。您是否認為您在銷售人員方面的投資足以真正增加歐洲的收入，或者您只是為我稍微規劃一下這一點就好了。

Yeah, European business is growing nicely and you have seen that we grow so 75% on the Brukinsa side and increasingly, and we also, increasingly we have more new patient to share so for Brukinsa. And in terms of Brukinsaand we get a new product launched in Germany, in Austria, Spain, and also some other countries like Switzerland, Norway. And we also got a reimbursement and reimbursement countries keep increasing and the launch activity is on track in the rest of the world.

是的，歐洲業務發展良好，您已經看到，Brukinsa 方面的成長速度達到 75%，並且還在不斷增長，而且，我們也為 Brukinsa 帶來了越來越多的新患者。就 Brukinsaand 而言，我們在德國、奧地利、西班牙以及瑞士、挪威等其他一些國家推出了一款新產品。我們也獲得了報銷，報銷國家不斷增加，世界其他地區的發射活動也按計畫進行。

And you can see our business grow so 146%. Remarkable. And we have also launched Brukinsa in Japan. And also, recently, and we also got approval of Tevimbra in multiple countries in Brazil, in South Korean reimbursement, Australia reimbursement, and this also we see significant progress in Tevimbra.

您可以看到我們的業務成長了 146%。卓越。我們也在日本推出了 Brukinsa。而且最近，我們也在巴西、韓國、澳洲等多個國家獲得了 Tevimbra 的報銷批准，我們也看到了 Tevimbra 的重大進展。

Thank you.

謝謝。

Thank you. Our final question comes from Yigal Nochomovitz from Citigroup. Please mute your line and ask your question.

謝謝。我們的最後一個問題來自花旗集團的 Yigal Nochomovitz。請靜音並提出您的問題。

Hi, great. Thank you very much. I had a few questions. First, on Zen, Sonro plus Zanu pricing. I know it's early, but I'd like to get your early thoughts if you're expecting that to be price neutral with Brukinsa, with the idea to take more share with a better profile or possibly a premium. And then you talked a lot about supply chain resiliency and you mentioned the sourcing of API in Switzerland and Spain. Obviously you have the filmin in the United States. I'm wondering if there's some long range plans to additionally introduce an API supply within the United States. And then finally, John, you talked a lot about resiliency. I'm curious about geographic resiliency, specifically with respect to R&D, with the redominantile in Switzerland, do you expect to move more of the core R&D outside of China to Switzerland as well as the US?

嗨，太好了。非常感謝。我有幾個問題。首先，關於 Zen、Sonro 和 Zanu 的定價。我知道現在還為時過早，但如果您預計 Brukinsa 的價格會保持中性，並希望透過更好的形像或可能的溢價來獲得更多的份額，我想聽聽您的早期想法。然後您談了很多關於供應鏈彈性的問題，並提到了在瑞士和西班牙採購 API。顯然這部電影是在美國拍攝的。我想知道是否有一些長期計劃在美國境內額外引入 API 供應。最後，約翰，你談了很多關於彈性的問題。我對地理彈性很感興趣，特別是在研發方面，由於瑞士佔據主導地位，您是否希望將更多核心研發從中國轉移到瑞士和美國？

Thank you very much.

非常感謝。

So thanks for the question you. So I'll take the first couple and then hand it over to John. It's way too early to talk pricing with respect to our pipeline assets. All I'll say is we're really confident, in the profiles that these assets, have in front of them, and we'll price them accordingly relative to the value that they're creating patients.

感謝您的提問。所以我會拿走第一對然後把它交給約翰。現在談論我們的管道資產定價還為時過早。我想說的是，我們對這些資產的概況非常有信心，我們會根據它們為患者創造的價值來定價。

With respect to supply chain resiliency, yes, we're very enthused by the efforts we've taken in the past to ensure that we have supply and resilience for patients all around the world. Obviously, we are monitoring all the activity that's happening in the environment, and we'll be sure that we take measures to proactively ensure that supply for US patients, but really importantly, patients everywhere around the world, so.

關於供應鏈彈性，是的，我們對過去為確保為世界各地的患者提供供應和彈性所做的努力感到非常興奮。顯然，我們正在監測環境中發生的所有活動，我們將確保採取措施積極確保為美國患者提供藥物，但真正重要的是，為世界各地的患者提供藥物。

Yeah, we're, as you mentioned, we're excited about things from a global perspective, and I think the organization is always in this like global expansion mode. Last quarter, I think you heard us talk about opening operations in South Africa for. For example, today, the management team is sitting here in our San Carlos, office in R&D center, and, excited to be, interviewing and recruiting people here for the R&D perspective too. So, I just think it's, inevitable expansion, process as we try to work globally with everyone and from a research, from a clinical and getting great medicines to patients for studying.

是的，正如您所說，我們對從全球視角看待事物感到興奮，我認為組織始終處於這種全球擴張模式。上個季度，我想您聽到我們談論在南非開展業務。例如，今天，管理團隊坐在我們位於聖卡洛斯的研發中心辦公室裡，很高興在這裡面試和招募研發人員。所以，我認為這是一個不可避免的擴張過程，因為我們試圖與全球的每個人合作，從研究、從臨床到為患者提供優質藥物進行研究。

Thank you.

謝謝。

Thanks.

謝謝。

There are no further questions, I will turn the call over to John Oyler for closing remarks.

沒有其他問題了，我會把電話交給約翰·奧伊勒 (John Oyler) 作結束語。

Thanks so much. I think our first quarter execution across the key priorities really sets a strong foundation for 2025, and I'm really looking forward to sharing more updates and milestones with all of you throughout the year. So thanks so much for joining us today and taking your time and energy and for the very thoughtful process, and have a wonderful day.

非常感謝。我認為我們第一季在關鍵優先事項上的執行確實為 2025 年奠定了堅實的基礎，我非常期待全年與大家分享更多更新和里程碑。非常感謝您今天加入我們，花費時間和精力，並進行了非常周到的籌備，祝您有美好的一天。