美國安進 (AMGN) 2025 Q3 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for the Amgen Q3 2025 earnings conference call. (Operator Instructions) I would now like to introduce Casey Capparelli, Vice President of Investor Relations. Mr. Capparelli, you may now begin.

我叫朱莉安，今天我將擔任安進公司 2025 年第三季財報電話會議的主持人。（操作員指示）現在我謹向大家介紹投資人關係副總裁凱西‧卡帕雷利。卡帕雷利先生，您可以開始了。

Thank you, Julianne, and good afternoon, everyone. Welcome to our third quarter 2025 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Peter Griffith, Murdo Gordon and Jay Bradner. Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results could vary materially. Over to you, Bob.

謝謝你，朱莉安娜，大家下午好。歡迎參加我們2025年第三季財報電話會議。Bob Bradway 將主持電話會議，隨後 Peter Griffith、Murdo Gordon 和 Jay Bradner 將對我們的表現進行更廣泛的回顧。在今天的討論中，我們將使用非公認會計準則財務指標來描述我們的業績，並在本次電話會議的隨附資料中提供了適當的調整表。我們也會做出一些前瞻性陳述，但這些陳述都受到我們的安全港聲明的限制。請注意，實際結果可能與此有很大差異。接下來就交給你了，鮑伯。

Okay. Good afternoon, everyone, and thank you for joining us today. Amgen delivered another strong quarter, driven by rising demand for our medicines and meaningful progress across the pipeline. Volume growth once again paced our progress in an environment where selling prices are declining across the industry.

好的。各位下午好，感謝各位今天參加我們的節目。安進公司又迎來了一個強勁的季度，這得益於市場對我們藥品的需求不斷增長以及研發管線取得的顯著進展。在整個產業售價不斷下降的環境下，銷售成長再次引領了我們的發展步伐。

This volume growth reflects the strength of our portfolio and the value our medicines provide to patients and prescribers. We saw growth across all four therapeutic areas this quarter. Revenues were up 12% year-over-year and volume up 14%. Sixteen of our products grew double-digit rates and 14 are now annualizing at over $1 billion in sales.

銷售成長反映了我們產品組合的實力以及我們的藥品為患者和處方醫生帶來的價值。本季我們所有四個治療領域均實現了成長。營收年增 12%，銷量較去年同期成長 14%。我們有 16 款產品實現了兩位數的成長，其中 14 款產品的年銷售額現已超過 10 億美元。

Our broad base of innovative medicines is generating powerful momentum and gives us confidence in our ability to sustain long-term growth. We've also been working to expand access to our medicines. And we recently launched AmgenNow, a new direct-to-patient platform that allows qualified patients in the US to access Repatha at one of the lowest prices in the world. This is an important step forward in helping more people benefit from the kind of innovation that's represented by Repatha.

我們廣泛的創新藥物基礎正在產生強大的發展勢頭，這使我們有信心保持長期成長。我們也一直在努力擴大藥品的取得途徑。我們最近推出了 AmgenNow，這是一個全新的直接面向患者的平台，使美國符合條件的患者能夠以全球最低的價格之一獲得 Repatha。這是幫助更多人受益於 Repatha 所代表的那種創新的重要一步。

Let me take a moment to recognize the scale and complexity of what we do in biologics manufacturing, which is both an art and a science. And at Amgen, we've built one of the most advanced capabilities in the world in making large molecules.

請允許我花一點時間來認識到我們在生物製劑生產中所做工作的規模和複雜性，這既是一門藝術，也是一門科學。在安進，我們已經建立了世界上最先進的大分子藥物生產能力​​之一。

We benefit from 45 years of experience in this space and from having a manufacturing network that's predominantly based here in the US, serving American patients and patients all around the world since our inception. We continue to invest in manufacturing with more than $3 billion in planned investments in the US this year alone. This builds on over $40 billion invested in manufacturing and research and development since the passage of the Tax Cuts and Jobs Act in 2017. This foundation positions us well to support growing global demand for our products.

我們擁有 45 年的行業經驗，我們的製造網絡主要設在美國，自公司成立以來，我們一直為美國患者和世界各地的患者提供服務。我們將繼續加大對製造業的投資，光是今年就計劃在美國投資超過30億美元。自 2017 年《減稅與就業法案》通過以來，美國已在製造業、研發領域投資超過 400 億美元。這項基礎使我們能夠更好地滿足全球對我們產品日益增長的需求。

Now let me just turn briefly to each of our four therapeutic areas. In General Medicine, we're expanding our impact across underserved disease areas with substantial runway. Cardiovascular disease remains the world's leading public health challenge with tens of millions of patients at risk for heart attack and stroke.

現在讓我簡單地介紹一下我們的四個治療領域。在全科醫學領域，我們正在擴大對服務不足的疾病領域的影響力，並擁有巨大的發展空間。心血管疾病仍然是世界面臨的首要公共衛生挑戰，數千萬患者面臨心臟病發作和中風的風險。

At the upcoming American Heart Association meeting, we will share data on Repatha, showing important benefits in preventing a first heart attack or stroke. We had a powerful signal for the impact or potential impact of Repatha in primary prevention.

在即將舉行的美國心臟協會會議上，我們將分享有關 Repatha 的數據，這些數據表明 Repatha 在預防首次心臟病發作或中風方面具有重要益處。我們從中得到了關於 Repatha 在一級預防中的影響或潛在影響的強烈訊號。

In bone health, EVENITY is a transforming care for postmenopausal women at high risk of fracture. It is the first and only bone-building therapy that increases bone formation and decreases bone resorption. EVENITY continues to deliver strong performance and with treatment rates still low among women with high fracture risk, we believe there is significant room for growth. We expect this product to remain a growth driver throughout its life cycle.

在骨骼健康領域，EVENITY 為骨折高風險的停經後婦女提供了變革性的照護方案。它是第一個也是唯一一個能夠促進骨骼形成並減少骨骼吸收的骨骼建構療法。EVENITY 繼續保持強勁的業績，但對於骨折風險高的女性來說，治療率仍然很低，我們認為還有很大的成長空間。我們預計該產品在其整個生命週期中將持續成為成長動力。

Looking ahead, both MariTide and olpasiran offer additional pathways for growth in obesity and cardiovascular disease, two of the world's most pressing health issues. In rare disease, our portfolio of growth drivers are all early in their life cycle.

展望未來，MariTide 和 olpasiran 都為肥胖症和心血管疾病（世界上兩個最緊迫的健康問題）提供了更多成長途徑。在罕見疾病領域，我們目前所有成長驅動因素都處於生命週期的早期階段。

These products are performing well now, and we expect them to continue to grow well into the future. For example, with new indications such as IgG4-related disease and generalized myasthenia gravis on the horizon for UPLIZNA, we're excited by what this product can offer an increasingly broad range of patients.

這些產品目前表現良好，我們預計它們在未來將繼續保持良好的成長勢頭。例如，隨著 UPLIZNA 有望用於治療 IgG4 相關疾病和全身性重症肌無力等新適應症，我們對該產品能夠為越來越多的患者帶來益處感到非常興奮。

I would also say that the progress that we are seeing with UPLIZNA across a range of different diseases, reaffirms our belief for the potential of CD19-directed therapies to address a wide range of rare autoimmune diseases.

我還要說，我們在 UPLIZNA 治療各種不同疾病方面所取得的進展，再次印證了我們對 CD19 標靶療法在治療各種罕見自體免疫疾病方面的潛力的信念。

In inflammation, we've been a leader for decades, and we are very encouraged by what we're seeing with TEZSPIRE as physicians are increasingly comfortable with its profile, increasingly comfortable with the fact that it is a well-tolerated and broadly effective agent able to intervene upstream in the inflammatory cascade. We remain highly encouraged by the long-term prospects for TEZSPIRE.

在發炎領域，我們幾十年來一直是領導者，我們對 TEZSPIRE 的發展前景感到非常鼓舞，因為醫生們越來越認可它的特性，越來越認可它是一種耐受性良好且療效廣泛的藥物，能夠從上游幹預炎症級聯反應。我們對 TEZSPIRE 的長期前景依然充滿信心。

In oncology, we're continuing to establish new standards of care, IMDELLTRA has generated strong clinical enthusiasm in small cell lung cancer. BLINCYTO is, of course, now firmly established as the standard of care in frontline consolidation for B-cell acute lymphoblastic leukemia.

在腫瘤學領域，我們不斷建立新的治療標準，IMDELLTRA 在小細胞肺癌領域引起了強烈的臨床熱情。當然，BLINCYTO 目前已穩固確立為 B 細胞急性淋巴性白血病一線鞏固治療的標準療法。

And we are seeing encouraging project -- progress rather with xaluritamig in prostate cancer as it advances through Phase 3. Meanwhile, our biosimilar strategy continues to deliver results as well. You can see that in the quarter, our revenues were up more than 50% year-over-year and are now annualizing at roughly $3 billion in sales.

我們看到，隨著 xaluritamig 在前列腺癌治療中進入 3 期臨床試驗，該計畫取得了令人鼓舞的進展。同時，我們的生物相似藥策略也持續取得成效。從數據可以看出，本季我們的營收年增超過 50%，年銷售額約 30 億美元。

To close, let me just say that we continue to engage with policymakers in Washington and elsewhere around the world to support policies that improve access protect innovation and strengthen the biomanufacturing ecosystem, especially here in the US. We've built a strong springboard for 2026.

最後，我想說，我們將繼續與華盛頓和世界各地的政策制定者進行溝通，以支持那些能夠改善生物製造生態系統、保護創新並加強生物製造生態系統的政策，尤其是在美國。我們為2026年打下了堅實的基礎。

The products that will drive our next wave of growth are in hand, supported by compelling data reinforced by readouts this year and still early in their life cycle. We're encouraged by the momentum we're seeing in the business and confident in our ability to deliver innovation and growth well into the next decade. I want to extend my thanks to our colleagues around the world for their commitment to patients. With that, let me turn it over to Peter for a financial update. Thank you.

推動我們下一波成長的產品已經到位，今年公佈的數據也印證了這一點，而且這些產品目前仍處於生命週期的早期階段。我們對公司目前的業務發展勢頭感到鼓舞，並有信心在未來十年繼續保持創新和成長。我要感謝世界各地的同事們對病人的奉獻精神。接下來，我將把發言權交給彼得，讓他為大家帶來最新的財務介紹。謝謝。

Thank you, Bob. We are pleased with our strong third quarter performance and remain on track with our 2025 full year goals and long-term objectives. The financial results are shown on Slide 6 and 7 of the slide deck.

謝謝你，鮑伯。我們對第三季強勁的業績感到滿意，並將繼續朝著 2025 年全年目標和長期目標穩步前進。財務結果顯示在投影片的第 6 頁和第 7 頁。

In the third quarter, revenues increased 12% year-over-year to $9.6 billion, reflecting the continued strong performance of our six key growth drivers, Repatha, EVENITY, TEZSPIRE, and our innovative oncology, rare disease and biosimilar portfolios.

第三季度，公司營收年增 12% 至 96 億美元，這反映了我們六大關鍵成長驅動因素——Repatha、EVENITY、TEZSPIRE 以及我們創新的腫瘤、罕見疾病和生物相似藥產品組合——的持續強勁表現。

The quarter also benefited from discrete items, including roughly $250 million from favorable changes to US estimated sales deductions and a government order for Nplate of $90 million. I would also note that the third quarter included $105 million in sales for RAVICTI a small molecule within the rare disease portfolio, for which we now have a generic competitor as of October.

本季也受惠於一些特殊項目，包括美國預計銷售扣除額的有利變化帶來的約 2.5 億美元收入，以及政府向 Nplate 訂購的 9,000 萬美元訂單。我還想指出，第三季包括罕見疾病產品組合中的小分子藥物 RAVICTI 的 1.05 億美元銷售額，而從 10 月開始，我們已經有了該藥物的仿製藥競爭對手。

Our non-GAAP operating margin was 47% and reflects significant investments across the business, led by non-GAAP R&D growth of 31% year-over-year. This includes several business development transactions, resulting in roughly $200 million of incremental R&D spending.

我們的非GAAP營業利潤率為47%，反映了公司各業務領域的重大投資，其中非GAAP研發年增31%。這其中包括幾項業務發展交易，帶來了約 2 億美元的新增研發支出。

Excluding these business development transactions, Q3 non-GAAP operating expenses rose 14%, and non-GAAP R&D grew 19% year-over-year. reflecting increased investment in our late-stage pipeline. Our continued investments in programs, including MariTide, Olpasiran, Xaluritamig and rare disease will drive sustainable, long-term growth and strengthen our leadership and innovation.

剔除這些業務拓展交易後，第三季非GAAP營運費用年增14%，非GAAP研發費用年增19%，反映我們對後期研發管線的投資增加。我們持續投資於包括 MariTide、Olpasiran、Xaluritamig 和罕見疾病在內的項目，這將推動可持續的長期成長，並加強我們的領導地位和創新能力。

Our non-GAAP OI&E resulted in a $568 million expense. We continue to strengthen our balance sheet with $4.5 billion of debt retired in 2024 and $6.0 billion of debt retired in 2025. We are pleased to report that we have returned to our pre-Horizon capital structure ahead of plan, and we will achieve greater than $500 million in pretax cost synergies in 2025 in connection with the acquisition.

我們的非GAAP營運盈虧導致支出5.68億美元。我們將繼續強化資產負債表，2024 年償還 45 億美元債務，2025 年償還 60 億美元債務。我們很高興地宣布，我們已提前恢復到 Horizo​​​​n 收購前的資本結構，我們將在 2025 年透過此次收購實現超過 5 億美元的稅前成本協同效應。

Our non-GAAP tax rate increased 4.8 percentage points year-over-year to 18.2% primarily due to the change in earnings mix. We generated $4.2 billion in free cash flow in the third quarter, reflecting operational momentum across the business rigorous management of working capital, all while continuing to invest in innovation.

由於獲利結構的變化，我們的非GAAP稅率年增4.8個百分點至18.2%。第三季度，我們創造了 42 億美元的自由現金流，這反映了公司營運的良好勢頭、嚴格的營運資本管理，以及對創新持續投資。

In addition to the increase of 31% in non-GAAP R&D described above, we continue to advance and accelerate technology and AI across the value chain from discovery to development to manufacturing and through to commercial execution. AI and trial enrollment, manufacturing optimization and customer engagement are all among areas leveraging innovation to drive productivity at speed and scale. We're also accelerating molecule design and other aspects of early-stage research powered by modernized AI and data platforms.

除了上文所述的非GAAP研發投入成長31%之外，我們也將持續推動並加速整個價值鏈（從發現到開發到製造，直至商業化執行）中的技術和人工智慧發展。人工智慧和試驗註冊、生產優化和客戶互動等領域都在利用創新來快速、大規模地提高生產力。我們也藉助現代化的AI和資料平台，加速分子設計和其他早期研究的進展。

For 2025, we now expect capital expenditures of roughly $2.2 billion to $2.3 billion to expand network capacity for our products across the portfolio and our innovative pipeline, including MariTide. Our capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, California and Massachusetts.

到 2025 年，我們預計將投入約 22 億至 23 億美元的資本支出，以擴大我們產品組合和創新產品線（包括 MariTide）的網路容量。我們的資本支出反映了我們在美國各地的重大投資，包括俄亥俄州、北卡羅來納州、波多黎各、羅德島州、加利福尼亞州和馬薩諸塞州。

We expect our projects to continue to be on budget and on time. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share, representing a 6% increase compared to the third quarter of 2024.

我們預計我們的專案將繼續在預算範圍內按時完成。此外，我們透過每股 2.38 美元的有競爭力的股息支付向股東返還了資本，與 2024 年第三季相比增長了 6%。

Turning to the outlook for the business for 2025 on Slide 8. The benefit of our portfolio was clearly seen this quarter, and coupled with momentum across the business, we are raising our 2025 guidance ranges for both revenue and non-GAAP earnings per share.

接下來請看第 8 張投影片，了解公司 2025 年的業務展望。本季我們投資組合的優勢已顯而易見，加上業務整體發展勢頭良好，我們將 2025 年的營收和非 GAAP 每股收益預期範圍均上調。

We expect 2025 total revenues in the range of $35.8 billion to $36.6 billion and non-GAAP earnings per share between $20.60 and $21.40. This guidance includes the estimated impact of implemented tariffs. It does not account for tariffs or pricing actions announced or described but not yet implemented.

我們預計2025年總營收將在358億美元至366億美元之間，非GAAP每股收益將介於20.60美元至21.40美元之間。該預期已包含已實施關稅的預期影響。它並未考慮已宣布或描述但尚未實施的關稅或定價措施。

In addition, let me highlight a few updates to our outlook for the remainder of the year. For the full year, we now expect other revenue to be approximately $1.5 billion. Non-GAAP R&D expenses are now expected to grow at a mid-20s percentage rate year-over-year in 2025. This is driven by increased investment in our late-stage programs and the previously mentioned Q3 business development transactions. We now anticipate non-GAAP OI&E to be in the range of $2.1 billion to $2.2 billion in 2025. We now expect a non-GAAP tax rate in the range of 15.0% to 16.5%.

此外，我還想重點介紹一下我們對今年剩餘時間的展望的一些更新。我們現在預計全年其他收入約為15億美元。非GAAP研發預計到 2025 年，支出將以每年 20% 左右的速度成長。這主要得益於我們對後期專案投入的增加以及前面提到的第三季業務發展交易。我們現在預計，2025 年非 GAAP 營業收入和支出將在 21 億美元至 22 億美元之間。我們現在預計非GAAP稅率將在15.0%至16.5%之間。

And for WEZLANA in the United States, we continue to expect quarterly sales to fluctuate and do not expect any sales in the fourth quarter. And let me remind you of prior items that have not changed. We continue to expect the full year non-GAAP operating margin as a percentage of product sales to be roughly 45%.

至於美國 WEZLANA 公司，我們預計季度銷售額仍將波動，並且預計第四季不會有任何銷售額。讓我提醒各位，之前提到的一些事項沒有改變。我們仍預期全年非GAAP營業利潤率佔產品銷售額的百分比約為45%。

The outlook continues to reflect our investments in advancing key late-stage programs, including MariTide, Olpasiran, rare disease and Xaluritamig and leveraging technological advancements, including artificial intelligence. Our operating margin outlook also includes incremental launch and commercial investments.

前景繼續反映我們對推進關鍵後期項目（包括 MariTide、Olpasiran、罕見疾病和 Xaluritamig）以及利用技術進步（包括人工智慧）的投資。我們的營業利益率預期還包括新增產品上市和商業投資。

We're focused on delivering sustained long-term growth and value for patients and shareholders by doing what we said we would do: Driving innovation in areas of high unmet medical needs and maintaining rigorous financial discipline. We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth throughout the long term.

我們致力於為患者和股東帶來持續的長期成長和價值，具體做法是：在醫療需求未充分滿足的領域推動創新，並保持嚴格的財務紀律。我們將繼續專注於提升企業整體的執行力，並保持良好的發展勢頭，以實現長期的持續成長。

I'm grateful to work with all of our colleagues worldwide in serving patients. This concludes our financial update. I'll now hand it over to Murdo for an update on our strong commercial progress in the quarter. Murdo?

我很榮幸能與世界各地的同事們一起為病患服務。我們的財務更新到此結束。現在我將把發言權交給默多，讓他報告我們本季強勁的商業進展。默多？

Thanks, Peter. In the third quarter, sales increased 12% year-over-year, driven by 14% volume growth. 16 products delivered double-digit or better growth, clear evidence of the strength of our portfolio and the disciplined execution of our teams around the world. Starting with General Medicine. Repatha delivered $794 million in the third quarter sales, up 40% year-over-year and now annualizing at approximately $3 billion.

謝謝你，彼得。第三季度，銷售額年增12%，主要得益於銷量成長14%。 16款產品實現了兩位數或更高的成長，這充分體現了我們產品組合的實力以及全球團隊的高效執行。從全科醫學開始。Repatha 第三季銷售額達 7.94 億美元，年增 40%，年銷售額約 30 億美元。

Since Repatha's launched a decade ago, the PCSK9 inhibitor class remains underutilized with these therapies currently reaching fewer than 5% of patients eligible for lipid-lowering therapy. With roughly 100 million people still in need of effective LDL-C lowering Repatha has a substantial opportunity to expand its use to address cardiovascular disease, the world's number one public health crisis.

自 Repatha 十年前上市以來，PCSK9 抑制劑類藥物仍未充分利用，目前只有不到 5% 的符合降血脂治療條件的患者接受了此類療法。目前仍有約 1 億人需要有效降低 LDL-C 水平，Repatha 有很大的機會擴大其用途，以應對心血管疾病——世界頭號公共衛生危機。

As you'll hear from Jay, we have recently announced important data from the VESALIUS-CV outcome study, which met its dual major adverse cardiovascular events or MACE endpoints in patients at elevated cardiovascular risk without prior heart attack or stroke. I've worked in lipid management for more than 30 years, and I've witnessed numerous landmark statin studies demonstrating how intensive LDL cholesterol lowering reduces cardiovascular risk.

正如您將從 Jay 那裡聽到的，我們最近公佈了 VESALIUS-CV 結果研究的重要數據，該研究達到了其雙重主要不良心血管事件 (MACE) 終點，研究對象為心血管風險升高但之前沒有心臟病發作或中風史的患者。我從事血脂管理工作超過 30 年，親眼見證了許多具有里程碑意義的他汀類藥物研究，這些研究表明，強化降低低密度脂蛋白膽固醇可以降低心血管風險。

The VESALIUS-CV results demonstrate that Repatha provides additive benefit above and beyond statins, delivering even more reduction in cardiovascular events in primary prevention patients at higher risk. Currently, greater than 95% of patients insured in the US have coverage for Repatha and most insured patients pay less than $50 out of pocket per month.

VESALIUS-CV 研究結果表明，Repatha 比他汀類藥物具有額外的益處，能夠進一步降低高風險一級預防患者的心血管事件發生率。目前，美國超過 95% 的受保患者都享有 Repatha 的保險，大多數受保患者每月自付費用不到 50 美元。

The prior authorization requirements for many of these patients have also been removed or substantially reduced. In the US, we're taking bold steps to improve access with the launch of Amgen Now our new direct-to-patient program.

對於其中許多患者，事先授權要求也已被取消或大幅減少。在美國，我們正採取大膽舉措，透過推出新的直接面向患者的計畫 Amgen Now 來改善藥物可近性。

Repatha is the first therapy available through AmgenNow at a monthly price of $239 or roughly $8 a day. This is nearly 60% below the current US list price, which is already one of the lowest in the world. The launch of this program is a meaningful step toward providing additional affordability and access to Repatha for American patients.

Repatha 是第一個透過 AmgenNow 提供的療法，每月價格為 239 美元，約合每天 8 美元。這比目前美國的標價低了近 60%，而美國的標價已經是世界上最低的標價之一了。該計劃的啟動是朝著為美國患者提供更實惠的價格和更便捷的瑞百安（Repatha）治療方案邁出的重要一步。

EVENITY delivered $541 million in third quarter sales, up 36% year-over-year. In the US, sales grew 44%, driven by higher prescription volumes from both established and newly activated prescribers. EVENITY is the only therapy that builds bone and slows bone loss, which is a unique advantage in helping postmenopausal women reduce fracture risk.

EVENITY 第三季銷售額達 5.41 億美元，年增 36%。在美國，銷售額增加了 44%，這主要得益於現有處方醫生和新啟動處方醫生處方量的增加。EVENITY 是唯一能夠促進骨骼生長並減緩骨質流失的療法，這在幫助停經後婦女降低骨折風險方面具有獨特的優勢。

In the US, EVENITY continues to lead the bone builder segment with over 60% market share and approximately 270,000 patients treated to date. However, many remain at high risk of fracture. With close to 90% of the roughly 2 million very high-risk patients still not receiving appropriate therapy.

在美國，EVENITY 繼續引領骨骼構建劑市場，市佔率超過 60%，迄今已治療了約 27 萬名患者。然而，許多人仍然面臨較高的骨折風險。約 200 萬極高風險患者中，近 90% 的人仍未接受適當的治療。

In Japan, EVENITY has been prescribed to approximately 800,000 patients since launch, making it the leader in the bone builder category with greater than 50% market share. The success of EVENITY in Japan underscores the significant untapped potential in the US, where improvements in screening and diagnosis and increased treatment could meaningfully expand patient reach and drive continued growth.

在日本，EVENITY 自上市以來已被處方給約 80 萬名患者，使其成為骨骼構建劑類別的領導者，市佔率超過 50%。EVENITY 在日本的成功凸顯了美國巨大的未開發潛力，在美國，篩檢和診斷的改進以及治療的增加可以顯著擴大患者覆蓋範圍並推動持續增長。

Prolia delivered $1.1 billion in sales, an increase of 9% year-over-year. Three biosimilars have launched today in the US, and we see competitive dynamics evolving in line with expectations. In future quarters, we expect increased competition to negatively impact Prolia sales.

Prolia 的銷售額達到 11 億美元，年增 9%。今天，美國推出了三款生物相似藥，我們看到競爭格局的發展符合預期。我們預計未來幾季競爭加劇將對 Prolia 的銷售產生負面影響。

Our rare disease portfolio grew 13% year-over-year to $1.4 billion, now annualizing at over $5 billion with strong performance across the board. UPLIZNA sales increased 46% year-over-year to $155 million. The launch of UPLIZNA in IgG4-related disease is progressing well with significant uptake of rheumatologists and key academic medical centers. While IgG4-related disease is a recently defined condition, our educational efforts are rapidly building awareness and diagnosis.

我們的罕見疾病產品組合年增 13%，達到 14 億美元，目前年化收入超過 50 億美元，各方面表現強勁。UPLIZNA 的銷售額年增 46%，達到 1.55 億美元。UPLIZNA 在 IgG4 相關疾病領域的上市進展順利，風濕病學家和主要學術醫療中心都給予了顯著的認可。雖然 IgG4 相關疾病是一種近期才被定義的疾病，但我們的教育工作正在迅速提高人們對該疾病的認識和診斷水平。

We've seen over 300 unique prescribers since launch across multiple specialties, demonstrating breadth of adoption of UPLIZNA in this indication. UPLIZNA is a leading FDA-approved treatment for NMOSD with growth driven by increased new patient demand and strong rates of treatment initiations and adherence.

自上市以來，我們已經看到超過 300 位來自不同專業的醫生開立了 UPLIZNA 處方，這表明 UPLIZNA 在該適應症中得到了廣泛的應用。UPLIZNA 是 FDA 批准的治療 NMOSD 的領先藥物，其增長得益於新患者需求的增加以及治療啟動率和依從性的提高。

Additionally, launch preparations are underway for the anticipated approval of UPLIZNA in generalized myasthenia gravis or GMG, a chronic autoimmune neuromuscular disorder driven by pathogenic B cells. We look forward to the potential of serving more patients who can benefit from UPLIZNA's differentiated profile, including its durable efficacy and convenient dosing and administration.

此外，UPLIZNA 有望獲準用於治療全身性重症肌無力（GMG），這是一種由致病性 B 細胞驅動的慢性自體免疫神經肌肉疾病，目前正在進行上市準備工作。我們期待能為更多患者提供服務，讓他們受益於 UPLIZNA 的差異化特性，包括其持久的療效和方便的給藥方式。

TEPEZZA grew 15% to $560 million in the quarter, driven by increases in inventory and price. We're encouraged by our launch in Japan, where more than 800 patients have been treated with TEPEZZA since December. In the US, approximately 25,000 patients have received treatment since launch to reach even more patients who can benefit from TEPEZZA, wecontinue to engage a broad prescriber base who have indicated an increasing intent to prescribe. TAVNEOS sales were $107 million in the third quarter, an increase of 34% year-over-year, driven by strong volume growth. More than 6,700 patients with ANCA-associated vasculitis have been treated with TAVNEOS in the US over 3,800 health care professionals of now prescribed TAVNEOS, representing a 31% increase in the prescriber base so far this year.

受庫存和價格上漲的推動，TEPEZZA 本季營收成長 15% 至 5.6 億美元。我們在日本的上市取得了令人鼓舞的成果，自去年 12 月以來，已有超過 800 名患者接受了 TEPEZZA 治療。在美國，自上市以來已有約 25,000 名患者接受了治療。為了使更多患者受益於 TEPEZZA，我們繼續與廣泛的處方醫生群體合作，他們已表示越來越有意願開立處方。TAVNEOS 第三季銷售額為 1.07 億美元，年成長 34%，主要得益於強勁的銷售成長。在美國，已有超過 6700 名 ANCA 相關血管炎患者接受了 TAVNEOS 治療；超過 3800 名醫療保健專業人員已開立 TAVNEOS 處方，今年迄今為止，處方醫生人數增加了 31%。

In inflammation, TEZSPIRE delivered another strong quarter with sales up 40% year-over-year to $377 million and has now achieved over $1 billion in sales year-to-date. TEZSPIRE is well positioned to help many more patients in the US, given its differentiated and broadly applicable profile to treat multiple triggers and drivers of severe uncontrolled asthma.

在發炎領域，TEZSPIRE 又取得了強勁的季度業績，銷售額年增 40% 至 3.77 億美元，今年迄今的銷售額已超過 10 億美元。TEZSPIRE 具有差異化和廣泛適用的特性，能夠治療多種導致嚴重未控制氣喘的誘因和驅動因素，因此它有望幫助美國更多的患者。

In addition, TEZSPIRE has recently been approved in the US for add-on maintenance treatment in adults and adolescents aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps. This disease is associated with elevated eosinophils and has observed in roughly 20% of patients with severe uncontrolled asthma.

此外，TEZSPIRE 最近已在美國獲批，用於治療 12 歲及以上患有控制不佳的慢性鼻竇炎伴鼻息肉的成人和青少年。這種疾病與嗜酸性粒細胞增多有關，在約 20% 的重度未控制氣喘患者中觀察到。

This reinforces TEZSPIRE proven efficacy in eosinophilic disease. Importantly, in this registrational trial, TEZSPIRE demonstrated a reduction in the need for surgery further expanding its value and potential to help an even broader in population.

這進一步證實了TEZSPIRE在嗜酸性粒細胞疾病的療效。重要的是，在這項註冊試驗中，TEZSPIRE 證明了手術需求的減少，進一步擴大了其價值和潛力，從而幫助了更廣泛的人群。

Our innovative oncology portfolio, which includes BLINCYTO, IMDELLTRA, LUMAKRAS, Vectibix, KYPROLIS, Nplate and Xgeva grew 9% year over year, generating $2.3 billion in third quarter sales. Growth in oncology is fueled by our industry-leading bispecific T cell engager platform,the foundation for IMDELLTRA and BLINCYTO. These medicines are redefining standards of care in difficult-to-treat cancers and extending survival for more patients worldwide.

我們創新的腫瘤產品組合，包括 BLINCYTO、IMDELLTRA、LUMAKRAS、Vectibix、KYPROLIS、Nplate 和 Xgeva，較去年同期成長 9%，第三季銷售額達 23 億美元。腫瘤學領域的成長得益於我們業界領先的雙特異性 T 細胞銜接器平台，該平台是 IMDELLTRA 和 BLINCYTO 的基礎。這些藥物正在重新定義難治性癌症的治療標準，並延長全球更多患者的存活期。

IMDELLTRA generated $178 million in third quarter sales, fueled by strong clinical conviction and rapid adoption across care settings. IMDELLTRA is widely recognized as the standard of care for patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy.

IMDELLTRA 第三季銷售額達 1.78 億美元，這得益於其強大的臨床療效和在各種醫療機構中的快速應用。IMDELLTRA 被廣泛認為是治療廣泛期小細胞肺癌且在化療期間或化療後病情進展患者的標準療法。

Over 1,400 sites of care in the US are now administering IMDELLTRA with more than half of the doses occurring in the community setting. Following superior clinical evidence in the Phase 3 DeLLphi-304304 study, the NCCN guidelines have been updated to reflect IMDELLTRA as the highest recommended therapy in the second-line setting. We look forward to the anticipated full confirmatory approval later this year.

目前美國有超過 1400 個醫療機構正在使用 IMDELLTRA，其中超過一半的劑量是在社區環境中接種的。在第 3 期 DeLLphi-304304 研究中獲得了更優異的臨床證據後，NCCN 指南已更新，將 IMDELLTRA 列為二線治療中最高推薦療法。我們期待今年稍後能夠獲得預期的全面確認批准。

BLINCYTO grew 20% year-over-year to $392 million in sales, driven by broad prescribing across both academic and community segments. We see strong conviction in BLINCYTO and standard of care in combination with continued multi aging chemotherapy for both adults and pediatric patients with Philadelphia chromosome-negative B-cell ALL.Our biosimilar portfolio delivered another strong quarter with sales increasing 52% year-over-year to $775 million and now annualizing at $3 billion. Since our first product approvals in 2018, our biosimilars have generated nearly $13 billion in sales. Additional launches are providing meaningful top line growth and durable cash flow.

BLINCYTO 的銷售額年增 20%，達到 3.92 億美元，這主要得益於學術界和社區領域的廣泛處方。我們對 BLINCYTO 以及與持續多齡化療聯合治療費城染色體陰性 B 細胞急性淋巴細胞白血病成人和兒童患者的標準療法充滿信心。我們的生物相似藥產品組合又迎來了一個強勁的季度，銷售額年增 52% 至 7.75 億美元，年化銷售額達到 30 億美元。自 2018 年我們的首批產品獲得批准以來，我們的生物相似藥已創造了近 130 億美元的銷售額。新推出的產品帶來了可觀的營收成長和穩定的現金流。

PAVBLU, a biosimilar to EYLEA continues to gain momentum reaching $213 million sales in the third quarter. Retina specialists have responded very positively to launch of PAVBLU, citing is convenient pre-filled syringe format and Amgen's high-quality biosimilar manufacturing as important advantages.

PAVBLU 是 EYLEA 的生物相似藥，其銷售勢頭持續強勁，第三季銷售額達到 2.13 億美元。視網膜專家對 PAVBLU 的上市給予了非常積極的評價，認為其便捷的預填充注射器形式和安進公司高品質的生物相似藥生產是重要的優勢。

I'm very pleased with our performance in the quarter, fueled by the unwavering commitment of Amgen employees around the world to deliver on the company's mission to serve patients. And now I'll hand it over to Jay.

我對我們本季的業績非常滿意，這得益於安進全球員工堅定不移地致力於實現公司服務患者的使命。現在我把它交給傑伊。

Thank you, Murdo, and good afternoon, everyone. The third quarter was a period of strong and disciplined execution across R&D. We advanced multiple late-stage programs and deepened the evidence base for our marketed medicines.

謝謝你，默多，大家下午好。第三季研發部門執行力強勁且紀律嚴明。我們推動了多個後期研發項目，並深化了已上市藥物的證據基礎。

Starting with MariTide, both of our Phase III chronic weight management studies are fully enrolled. Interest was significant, enrolling approximately 5,000 adults in roughly six months. We have rapidly advanced into additional Phase III studies with strong enrollment momentum in MARITIME-CV and MARITIME-HF for the study of atherosclerotic cardiovascular disease and heart failure, respectively.

從 MariTide 開始，我們的兩項 III 期慢性體重管理研究都已完成招募。參與人數眾多，約六個月內招募了約 5,000 名成年人。我們已迅速推進到其他 III 期研究，MARITIME-CV 和 MARITIME-HF 研究分別針對動脈粥狀硬化性心血管疾病和心臟衰竭，目前均有強勁的入組動能。

Recall, in our Phase 2 chronic weight management study, we observed statistically significant reductions in systolic blood pressure, triglycerides and hsCRP, a key marker of vascular inflammation. These statistically significant improvements in validated cardiovascular risk factors highlight the potential impact of MariTide beyond weight loss.

回想一下，在我們第 2 期慢性體重管理研究中，我們觀察到收縮壓、三酸甘油酯和 hsCRP（血管發炎的關鍵標記）均有統計學意義上的顯著降低。這些在已驗證的心血管風險因素方面具有統計意義的改善，凸顯了 MariTide 除了減肥之外的潛在影響。

We have also recently initiated two Phase III studies in obstructive sleep apnea. With six global Phase III studies now underway, we're building a robust evidence base for MariTide. In addition to MariTide, we are advancing our early-stage portfolio for obesity and obesity-related conditions. This includes AMG 513, presently in Phase 1 and a number of rising preclinical candidates for both incretin and non-incretin targets, featuring both oral and injectable routes of administration.

我們最近也啟動了兩項阻塞性睡眠呼吸中止症的 III 期研究。目前已有六項全球 III 期研究正在進行中，我們正在為 MariTide 建立強有力的證據基礎。除了 MariTide 之外，我們也正在推動肥胖症和肥胖相關疾病的早期產品組合。這其中包括目前處於 1 期臨床試驗階段的 AMG 513，以及一些針對腸促胰素和非腸促胰素靶點的新興臨床前候選藥物，這些藥物既有口服途徑也有註射途徑。

Beyond obesity, in General Medicine, as Murdo noted, the Repatha Phase III VESALIUS-CV clinical trial met its dual primary endpoints, demonstrating significant reductions in major adverse cardiovascular events or MACE, in higher-risk individuals without a prior heart attack or stroke. VESALIUS-CV asked a clinically vital question. Can people at higher risk for a first heart attack or stroke benefit from Repatha when it is added to optimized lipid-lowering therapy?

除了肥胖症之外，正如 Murdo 所指出的那樣，在普通醫學領域，Repatha III 期 VESALIUS-CV 臨床試驗達到了其雙重主要終點，證明在沒有心臟病發作或中風的高風險人群中，主要不良心血管事件 (MACE) 顯著減少。VESALIUS-CV 提出了一個具有臨床意義的重要問題。對於首次心臟病發作或中風風險較高的族群，在優化降血脂治療的基礎上加用瑞百安（Repatha）能否獲益？

This landmark study enrolled over 12,000 patients, approximately 85% of whom were maintained on moderate to intensive statin-based LDL-C-lowering therapy. At a median follow-up of approximately 4.5 years, both primary MACE endpoints were met, and no new safety signals were observed.

這項具有里程碑意義的研究招募了超過 12,000 名患者，其中約 85% 的患者接受了中等至強化的以他汀類藥物為基礎的 LDL-C 降低治療。經過約 4.5 年的中位隨訪，兩個主要 MACE 終點均已達到，且未觀察到新的安全性訊號。

We are very excited to share the full results from this trial at the American Heart Association Scientific sessions on November 8th and would encourage all to review the detailed data when presented. In addition to the VESALIUS-CV data, we will also present several real-world studies that report on the state of current lipid management and the effectiveness of Repatha treatment in clinical practice, as well as new data from the FOURIER open-label extension study.

我們非常高興能在 11 月 8 日舉行的美國心臟協會科學會議上分享這項試驗的完整結果，並鼓勵大家屆時仔細閱讀詳細數據。除了 VESALIUS-CV 數據外，我們還將展示幾項真實世界研究，這些研究報告了當前脂質管理的狀況以及 Repatha 治療在臨床實踐中的有效性，以及來自 FOURIER 開放標籤擴展研究的新數據。

Together, these data reinforce Repatha's long-term benefit and established safety profile while providing new insights into atherosclerotic cardiovascular disease risk management. The size, scope and ambition of our cardiovascular program, including efficacy from clinical trials and effectiveness from real-world data, demonstrates Amgen's unwavering commitment to people living with heart disease and the impact that affordable transformative medicines, like Repatha, can have on their care.

這些數據共同強化了 Repatha 的長期療效和已建立的安全特性，同時為動脈粥狀硬化性心血管疾病風險管理提供了新的見解。我們的心血管計畫規模、範圍和雄心，包括臨床試驗的療效和真實世界數據的有效性，都顯示了安進對心臟病患者的堅定承諾，以及像 Repatha 這樣價格合理的變革性藥物對他們治療的影響。

Turning to Olpasiran, our promising best-in-class small-interfering RNA medicine targeting Lp(a), we are pleased by the conduct and progression of the fully enrolled event-driven OCEAN(a) Phase III cardiovascular outcome study.

說到 Olpasiran，我們很有前途的同類最佳小幹擾 RNA 藥物，它靶向 Lp(a)，我們對已完成招募的事件驅動型 OCEAN(a) III 期心血管結果研究的開展和進展感到滿意。

We continue to follow the aggregate endpoint accrual rate which is lower than initial predictions. As the study matures, we will update on the date for primary analysis as appropriate. We retain strong conviction in the potential of lowering Lp(a) to reduce cardiovascular events owing to very compelling genetic and epidemiological data that link elevated Lp(a) to cardiovascular disease.

我們繼續關注總體終點事件發生率，該發生率低於最初的預測。隨著研究的深入，我們將酌情更新主要分析的日期。我們堅信降低 Lp(a) 水平能夠減少心血管事件，因為有非常令人信服的遺傳學和流行病學數據表明，Lp(a) 水平升高與心血管疾病有關。

Moving to our rare disease portfolio and UPLIZNA, we recently presented additional data from the Phase III MITIGATE trial in IgG4-related disease, featuring subgroup analyses stratified by baseline characteristics and organ involvement such as the pancreas, kidney and bile ducts. These data demonstrate benefits comparable to those seen in the overall trial population, supporting UPLIZNA's potential across the spectrum of IgG4-related disease patients.

再來看看我們的罕見疾病產品組合和 UPLIZNA，我們最近公佈了 IgG4 相關疾病 III 期 MITIGATE 試驗的更多數據，其中包括按基線特徵和器官受累情況（如胰腺、腎臟和膽管）分層的亞組分析。這些數據表明，UPLIZNA 的療效與整體試驗族群中觀察到的療效相當，支持 UPLIZNA 對 IgG4 相關疾病患者的潛在療效。

For UPLIZNA and generalized myasthenia gravis, we look ahead to the December 14 PDUFA date and continue to receive encouraging physician feedback that highlights the need and opportunity for highly active, durable and convenient treatment options for patients with gMG.

對於 UPLIZNA 和全身型重症肌無力，我們期待著 12 月 14 日的 PDUFA 日期，並繼續收到令人鼓舞的醫生反饋，這些反饋強調了為 gMG 患者提供高效、持久和便捷的治療方案的必要性和機會。

In inflammation, we are excited by the FDA and European Commission approvals of TEZSPIRE for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps for the benefit of adult and pediatric patients aged 12 and older.

在發炎方面，我們很高興 FDA 和歐盟委員會批准 TEZSPIRE 用於治療 12 歲及以上成人和兒童患者，以輔助維持治療控制不佳的慢性鼻竇炎伴鼻息肉。

The Phase III data supporting this approval revealed rapid and sustained symptom improvement and a meaningful reduction of systemic steroid use. Notably, among patients treated with TEZSPIRE, we observed a near uniform avoidance of surgical intervention.

支持此核准的 III 期臨床試驗數據顯示，症狀得到快速且持續的改善，全身性類固醇的使用量顯著減少。值得注意的是，在接受 TEZSPIRE 治療的患者中，我們觀察到幾乎所有人都避免了手術介入。

Additionally, our two Phase III studies of TEZSPIRE and chronic obstructive pulmonary disease are enrolling patients with moderate to very severe COPD with blood eosinophil counts greater than or equal to 150 cells per microliter. Our Phase III study in eosinophilic esophagitis continues to mature. By targeting thymic stromal lympho-poietin, or TSLP, at the top of the alarmin inflammatory cascade, TEZSPIRE targets the root cause of serious inflammatory diseases driven by Th2 inflammation.

此外，我們正在進行兩項針對 TEZSPIRE 和慢性阻塞性肺病的 III 期研究，招募患有中度至重度 COPD 且血液嗜酸性粒細胞計數大於或等於每微升 150 個細胞的患者。我們針對嗜酸性食道炎的 III 期研究正在不斷改進。TEZSPIRE 透過靶向位於警報發炎級聯頂端的胸腺基質淋巴細胞生成素（TSLP），來治療由 Th2 發炎驅動的嚴重發炎性疾病。

Moving to oncology. Our bispecific T cell engager or BiTE platform is delivering outstanding clinical results for patients facing advanced cancers. IMDELLTRA, our DLL-3 targeting BiTE molecule now established as standard of care in second line small cell lung cancer is generating compelling data in combination and in earlier lines of therapy. In September and October, we presented results from multiple arms of the DeLLphi-303 Phase 1B study of IMDELLTRA in patients with small cell lung cancer, tested in combination with a PD-L1 inhibitor as first-line maintenance therapy.

轉入腫瘤科。我們的雙特異性 T 細胞銜接器或 BiTE 平台為晚期癌症患者帶來了卓越的臨床療效。IMDELLTRA 是我們針對 DLL-3 的 BiTE 分子，目前已成為二線小細胞肺癌的標準療法，並且在聯合治療和早期治療中產生了令人信服的數據。9 月和 10 月，我們公佈了 IMDELLTRA 在小細胞肺癌患者中與 PD-L1 抑製劑聯合作為一線維持療法進行測試的 DeLLphi-303 1B 期研究的多個組別的結果。

IMDELLTRA demonstrated a promising overall survival of 25.3 months, approximately doubling survival observed in other studies featuring the existing standard of care. In separate arms of DeLLphi-303 IMDELLTRA tested its first-line treatment in combination with platinum-based chemotherapy and a PD-L1 inhibitor, demonstrated 12-month overall survival of 81%, with median overall survival not yet reached.

IMDELLTRA 顯示令人鼓舞的總存活期為 25.3 個月，大約是其他採用現有標準治療的研究觀察到的存活期的兩倍。在 DeLLphi-303 的不同治療組中，IMDELLTRA 測試了其第一線治療方案與鉑類化療和 PD-L1 抑制劑合併使用，結果顯示 12 個月總存活率為 81%，中位總存活期尚未達到。

In both settings, the safety profile was manageable and consistent with the known safety of each component. We are now evaluating these combinations in the pivotal DeLLphi-305 frontline maintenance and DeLLphi-312 frontline induction and maintenance Phase III studies.

在這兩種情況下，安全狀況都是可控的，並且與每個組件已知的安全性一致。我們現在正在關鍵的 DeLLphi-305 一線維持治療和 DeLLphi-312 一線誘導和維持治療 III 期研究中評估這些組合。

Previously, we shared the remarkable results of the DeLLphi-304 study, evaluating IMDELLTRA versus standard of care in subjects with relapsed extensive stage small cell lung cancer, after platinum-based first-line chemotherapy. The US regulatory submission has been accepted by the FDA with a PDUFA date of December 18, 2025.Regulatory reviews are also underway in a number of additional geographies.

先前，我們分享了 DeLLphi-304 研究的顯著成果，該研究評估了 IMDELLTRA 與鉑類一線化療後復發廣泛期小細胞肺癌患者的標準治療方案。美國FDA已接受該藥品的監管申請，PDUFA日期為2025年12月18日。目前，其他一些地區的監管審查也在進行中。

We are developing IMDELLTRA for expansive impact in small cell lung cancer and other DLL3-positive malignancies including Phase 1B studies evaluating novel agent combinations, less frequent dosing regimens and subcutaneous delivery.

我們正在開發 IMDELLTRA，以期在小細胞肺癌和其他 DLL3 陽性惡性腫瘤中產生廣泛影響，包括評估新型藥物組合、減少給藥頻率和皮下給藥的 1B 期研究。

As an oncologist, let me share that the impact of IMDELLTRA for patients facing such a challenging disease as small cell lung cancer is honestly very moving. This disease has seen little innovation in decades and IMDELLTRA is now benefiting so many in this fight. With BLINCYTO, our CD19-targeted BiTE medicines, we continue to work to improve and evolve the standard of care for patients here with B-cell acute lymphoblastic leukemia. Recently, we initiated a potentially registration-enabling study of subcutaneously administered blinatumomab in both adult and adolescents with relapsed or refractory B-ALL.

身為腫瘤科醫生，我想分享一下，IMDELLTRA 對像小細胞肺癌這樣具有挑戰性的疾病的患者的影響，確實非常令人感動。幾十年來，這種疾病的治療進展甚微，而 IMDELLTRA 現在正在幫助許多人對抗這種疾病。借助 BLINCYTO（我們的 CD19 靶向 BiTE 藥物），我們將繼續努力改進和發展 B 細胞急性淋巴細胞白血病患者的治療標準。最近，我們啟動了一項可能有助於註冊的研究，研究皮下注射 blinatumomab 對復發或難治性 B 細胞急性淋巴細胞白血病成人和青少年的療效。

Our first-in-class STEAP1-CD3 bispecific T-cell engager xaluritamig, is advancing in Phase III clinical development with two studies now underway. The first study, XALute, is enrolling patients with metastatic castrate-resistant prostate cancer who have previously been treated with taxane-based chemotherapy, comparing xaluritamig monotherapy versus investigator's choice of standard therapy.

我們首創的 STEAP1-CD3 雙特異性 T 細胞銜接器 xaluritamig 正在進行 III 期臨床開發，目前有兩項研究正在進行中。第一項研究 XALute 正在招募患有轉移性去勢抵抗性前列腺癌且先前接受過紫杉烷類化療的患者，比較 xaluritamig 單藥治療與研究者選擇的標準療法。

The second study, XALience is evaluating the combination of xaluritamig and abiraterone versus investigator's choice of standard therapy in patients with chemotherapy naïve, metastatic, castrate-resistant prostate cancer. We are also exploring xaluritamig and other combinations and in earlier stages of prostate cancer with multiple Phase 1B studies ongoing. Across IMDELLTRA, BLINCYTO and xaluritamig, we see meaningful long-term potential from our bispecific T-cell engager platform and remain committed to bringing transformative and innovative therapies like these to patients with cancer.

第二項研究 XALience 正在評估 xaluritamig 和 abiraterone 聯合治療與研究者選擇的標準療法在未接受過化療的轉移性去勢抵抗性前列腺癌患者中的療效。我們也正在探索 xaluritamig 和其他組合療法在早期前列腺癌的應用，目前正在進行多項 1B 期研究。我們看到，在 IMDELLTRA、BLINCYTO 和 xaluritamig 這三款產品中，我們的雙特異性 T 細胞銜接器平台具有重要的長期潛力，並將繼續致力於為癌症患者帶來此類變革性和創新性的療法。

Lastly, we are disappointed to announce that FORTITUDE-102, a Phase 1B/3 study of bemarituzumab plus chemotherapy nivolumab in patients with first-line gastric cancer was stopped for an adequate efficacy, at an ad hoc analysis requested by the data monitoring committee.

最後，我們遺憾地宣布，FORTITUDE-102（一項針對一線胃癌患者的貝馬裡單抗聯合化療藥物納武利尤單抗的 1B/3 期研究）因療效不足而終止，這是數據監察委員會要求進行的一項臨時分析的結果。

We are deeply grateful to the patients, investigators and research partners who made this study possible. We remain committed to creating and developing medicines for challenging cancers where unmet need is significant, as for patients with gastric cancer.

我們衷心感謝所有參與這項研究的患者、研究人員和研究合作夥伴，是他們的努力使這項研究得以完成。我們將繼續致力於研發和開發治療困難癌症的藥物，以滿足患者尚未充分滿足的需求，例如胃癌患者。

Here, however, the magnitude of observed efficacy did not meet our standard for an Amgen medicine. Beyond these innovative medicines, our next wave of biosimilar candidates is advancing in Phase 3 clinical development, featuring biosimilars to OPDIVO, KEYTRUDA and OCREVUS. With breadth and depth across our four therapeutic areas, we are excited about the potential to deliver for patients, and we are well positioned to deliver sustained long-term growth. In closing, thank you to the Amgen teams whose disciplined execution and patient-first mindset make this progress possible.

然而，在這裡觀察到的療效程度並沒有達到我們對安進公司藥物的標準。除了這些創新藥物之外，我們的下一批生物相似藥候選藥物正在推進 3 期臨床開發，其中包括 OPDIVO、KEYTRUDA 和 OCREVUS 的生物相似藥。憑藉我們在四大治療領域的廣度和深度，我們對為患者帶來福祉的潛力感到興奮，並且我們已做好充分準備，實現持續的長期增長。最後，感謝安進團隊，正是他們嚴謹的執行力和以病人為中心的理念，才使得這項進展成為可能。

I'll now turn it over to Bob for Q&A.

現在我將把問答環節交給鮑伯。

Okay. Thank you. Why don't you remind our callers of the procedure for asking questions, and we'll try to get to as many of you as possible. I know it's a couple of minutes past the top of the hour now. So we'll try to get through these. And if we don't get to everybody on the call, we'll be available afterwards to answer any outstanding questions. So, let's get started.

好的。謝謝。請您提醒來電者提問的流程，我們會盡量回覆每位來電者。我知道現在已經過了整點幾分鐘了。所以我們會努力克服這些困難。如果電話會議期間我們沒能解答所有人的問題，會後我們還會繼續解答任何未解決的問題。那麼，我們就開始吧。

(Operator Instructions) Our first question comes from Salveen Richter from Goldman Sachs.

（操作員說明）我們的第一個問題來自高盛的薩爾文·里希特。

Thanks for taking my question. With olpasiran, you mentioned best-in-class and in context of a competitive landscape out there. And you also noted that the event rate for the OCEAN(a) outcome study is lower than you expected.

謝謝您回答我的問題。您在談到 olpasiran 時，提到了同類最佳，並且是在當前競爭激烈的市場環境下。您也注意到，OCEAN(a) 結果研究的事件發生率低於您的預期。

Could you just speak to your confidence in this program and what the event rate means for a base case readout, whether it's now in 2027 versus year-end '26 prior? And then separately, from a BD perspective, you spoke to how you're back at pre-Horizon debt levels. How does this impact your approach to business development heading into 2026? Thank you.

您能否談談您對該專案的信心，以及事件發生率對於基準情況讀數意味著什麼，無論是現在 2027 年還是之前的 2026 年底？另外，從業務發展的角度來看，您也談到了您的債務水平已經回到了 Horizo​​​​n 之前的水平。這將如何影響您2026年的業務發展策略？謝謝。

Thank you very much, Salveen. I'll take the first question around olpasiran. And as I mentioned, our conviction remains very strong. The genetic association for Lp(a) in cardiovascular disease is crystal clear. from human genetics, from epidemiological data.

非常感謝你，薩爾文。我先回答關於olpasiran的第一個問題。正如我之前提到的，我們的信念依然非常堅定。Lp(a)與心血管疾病的遺傳關聯性非常明確，這可以從人類遺傳學和流行病學數據中得到證實。

Lp(a) is fundamentally an inflammatory lipoprotein particle, and we know a lot about that biology in the vascular beds from analogy to LDL-C. Olpasiran has true best-in-class properties. It's frequency of administration is better.

Lp(a) 從本質上是一種發炎性脂蛋白顆粒，我們透過類比 LDL-C 對血管床中的這種生物學特性有了很多了解。奧爾帕西蘭擁有真正一流的房產。它的給藥頻率較好。

The depth of Lp(a) suppression is better, has a very clean safety profile. OCEAN(a) is an event-driven study. We're accustomed to conducting these global studies, look at VESALIUS-CV. We're very pleased with study conduct and look forward when we do read this out to seeing the impact of olpasiran. We won't guide today on that particular date, but we'll keep all posted as it comes into focus.

Lp(a)抑制深度較佳，具有非常清晰的安全特性。OCEAN(a) 是一項事件驅動型研究。我們已經習慣進行這些全球性研究，看看 VESALIUS-CV 就知道了。我們對研究的進行非常滿意，並期待在公佈研究結果時看到olpasiran的影響。今天我們不會對具體日期給予明確指示，但一旦情況明朗，我們會及時通知大家。

And Salveen, I wouldn't say that the return to the leverage that we had pre-Horizon affects our thinking and business development to any great extent. We're actively looking for opportunities in business development.

薩爾文，我並不認為恢復到 Horizo​​n 成立之前的槓桿水平會對我們的思維和業務發展產生任何重大影響。我們正積極尋找業務拓展的機會。

As you know, we're particularly focused in the therapeutic areas that you're familiar with as areas of interest for us. And just given the number of things we have in the late-stage clinic right now, we're focused primarily on earlier-stage things. And the good news is there are more of those than late stage anyway. So we're focused to open for business, but we have been. So, thank you for the question.

如您所知，我們尤其專注於您熟悉的、也是我們感興趣的治療領域。鑑於目前我們處於後期臨床階段的項目數量眾多，我們主要專注於早期階段的項目。好消息是，這類患者的數量本來就比晚期患者多。所以我們正全力以赴地準備開業，而且我們一直都在這樣做。謝謝你的提問。

Our next question come from Terence Flynn atMorgan Stanley.

下一個問題來自摩根士丹利的特倫斯·弗林。

Hi, thanks for taking the question. I appreciate it. Peter, I was just wondering by level, I know you're going to give 2026 guidance at this point, but maybe you could walk us through some of the puts and takes that we should think about heading into 2026.

您好，感謝您回答這個問題。謝謝。Peter，我只是想問一下，你說的「級別」是指什麼？我知道你現在要給 2026 年的指導，但也許你可以帶我們了解我們在進入 2026 年時應該考慮的一些買入和賣出策略。

And then Jay, just one clarification on ROCKET ASTRO. I noticed you completed that trial and it said the safety was consistent. Just wondering if there is any gastrointestinal ulcerations in that study? I know you saw those before in some of the prior studies. Thank you.

然後 Jay，關於 ROCKET ASTRO，我還有一點需要澄清。我注意到您已完成那項試驗，結果顯示安全性良好。我想知道這項研究中是否有胃腸道潰瘍病例？我知道你之前在一些研究中看到過這些內容。謝謝。

Yes, Terence, thank you very much for the question. And I would point towards our key growth drivers when you think about the top line and where the company is going. We've just had an excellent quarter, 14% volume growth for Repatha, EVENITY, TEZSPIRE innovative onc, rare disease, now annualizing at over $5 billion off the quarter, biosimilars annualizing at close to $3 billion.

是的，特倫斯，非常感謝你的提問。如果要考慮營收成長和公司發展方向，我會專注於我們的關鍵成長驅動因素。我們剛剛度過了一個非常出色的季度，Repatha、EVENITY、TEZSPIRE 創新腫瘤和罕見疾病藥物的銷量增長了 14%，按季度計算，年化收入超過 50 億美元，生物相似藥的年化收入接近 30 億美元。

So that's how we're thinking about that. As we go down the P&L, maybe the easiest thing for me to do, Terence would be just to spend a minute because I think people probably are thinking about operating margin.

這就是我們考慮這個問題的方式。當我們繼續分析損益表時，特倫斯，對我來說最簡單的做法可能就是花一分鐘時間解釋一下，因為我認為大家可能都在考慮營業利潤率。

And we've been clear in the past number of years about that and when we have an opportunity to achieve cash-on-cash returns greater than our hurdle rate, we're going to drive those opportunities for shareholders. So nothing's changed in that. We're at about 47% operating margin level in 2024 as we continue to accelerate the investing in research and particularly development Terence, of our later-stage pipeline. We're going to continue and have continued to invest in 2025, again, focused on research and development.

過去幾年，我們一直明確表示，當有機會實現高於我們預期回報率的現金回報率時，我們將為股東創造這些機會。所以這方面沒有任何改變。2024 年，我們的營業利潤率約為 47%，因為我們將繼續加快對研發的投資，特別是對我們後期產品線的開發。我們將繼續並將繼續在 2025 年進行投資，重點仍然是研發。

We're going to stick with this disciplined capital allocation approach. We haven't changed from that investing in the best innovation, as Bob just said, looking externally inside the company internally, remains at the top of our capital allocation hierarchy. Nothing's changed there. So, we'll keep that up.

我們將繼續堅持這種嚴謹的資本配置方式。我們並沒有改變投資最佳創新的概念，正如鮑伯剛才所說，無論從外部或公司內部來看，這仍然是我們資本配置層級的首要任務。那裡什麼都沒變。所以，我們會繼續保持下去。

We haven't provided longer-term margin targets, so nothing into 2026. But I'd just say we remain focused on achieving industry-leading margins while continuing to invest in the very best innovation. So, as you think about the business going forward, here's a couple of thoughts for you to think about.

我們沒有提供長期利潤率目標，所以2026年之前沒有任何數據。但我只想說，我們將繼續專注於實現領先業界的利潤率，同時繼續投資於最好的創新。所以，當您考慮公司未來的發展方向時，這裡有幾點供您參考。

First, we're focused on our earlier pipeline. Bob just mentioned that again, investing in the best innovation to further build out that part of the pipeline. In terms of R&D expenses, I just want to note, we experienced what I might characterize as a step change increase in R&D expenses over the last year.

首先，我們專注於早期的產品線。鮑伯剛才又提到了這一點，要投資最好的創新技術，以進一步完善這部分產品線。關於研發費用，我只想指出，在過去一年裡，我們的研發費用經歷了可以說是突飛猛進的成長。

We don't anticipate an incremental step change going forward in terms of R&D expense, think of a lot of puts and takes there. We'd remind you that we've completed a number of Phase III studies in 2025, including Repatha VESALIUS-CV, confirmatory study from IMDELLTRA along with several Rocatinlimab, Bemarituzumab studies and we've added studies, of course, for MariTide, olpasiran, and xaluritamig, and those will carry forward into 2026.

我們預期未來研發支出不會有漸進式的大幅成長，這方面會有很多進退兩難的情況。我們想提醒您，我們在 2025 年完成了多項 III 期研究，包括 Repatha VESALIUS-CV、IMDELLTRA 的確認性研究以及幾項 Rocatinlimab、Bemarituzumab 研究，當然，我們還增加了 MariTide、olpasiran 和 xaluritamig 的研究，這些研究將持續到 2026 年。

I'd also remind you, Terence, that our non-GAAP operating margin guidance of roughly 45% for the full year 2025 includes $200 million of business development activities in the third quarter, along with some incremental launch and commercial investments in the fourth quarter.

特倫斯，我還想提醒你，我們對 2025 年全年的非 GAAP 營業利潤率預期約為 45%，其中包括第三季 2 億美元的業務發展活動，以及第四季度的一些新增上市和商業投資。

So just kind of summarizing hoping that answers your question and gives you some thoughts about where we're at this year and continuing into '26. We're going to continue to drive executional excellence. Productivity and ruthless prioritization around the organization. We worked very hard as an enterprise for many years to be among the leaders in margins in our industry and we certainly expect to continue to remain there. So, Terence, thank you very much for the question.

總結一下，希望能夠回答你的問題，並讓你對我們今年的現狀以及2026年的發展方向有一些想法。我們將繼續追求卓越的執行力。提高組織內部的生產力並進行嚴格的優先排序。多年來，我們作為一家企業付出了巨大的努力，力爭成為行業利潤率的領先者，我們當然希望繼續保持這一地位。特倫斯，非常感謝你的提問。

Jay, do you want to speak to ASTRO?

傑伊，你想和ASTRO談談嗎？

I gladly would Terence, thanks for asking for all on the call, ASTRO is a 52-week study of rocatinlumab, the OX40 directed T-cell rebalancing agent. In this case, in adolescents with moderate to severe atopic dermatitis, tested two doses, 150 and 300 milligrams.

特倫斯，我很樂意回答。感謝你代表所有參加電話會議的人提出這個問題。 ASTRO 是一項為期 52 週的 rocatinlumab 研究，rocatinlumab 是一種針對 OX40 的 T 細胞再平衡劑。在本例中，對患有中度至重度異位性皮膚炎的青少年進行了兩種劑量（150 毫克和 300 毫克）的測試。

We studied the medicine as monotherapy as well as combination therapy with low-dose steroids or calcineurin modulation. Study met its co-primary endpoints at 24 weeks, save quite consistent with the other studies. We did observe GI side effects, mostly mild in nature and not at an excessive rate. As we bring to close the 8 studies of the ROCKET program, we start to reflect on the target product profile, we'll have more to say about that in the near future.

我們研究了該藥物作為單一療法以及與低劑量類固醇或鈣調磷酸酶調節劑聯合療法的效果。該研究在 24 週時達到了其共同主要終點，與其他研究結果基本一致。我們確實觀察到了一些胃腸道副作用，但大多性質輕微，發生率也不高。隨著 ROCKET 計畫的 8 項研究接近尾聲，我們開始思考目標產品概況，我們將在不久的將來對此發表更多看法。

All right. Let's move on to the next question, see if we can keep it to one question so we can get through as many of you as possible. Who's next?

好的。我們繼續下一個問題，看看能不能只問一個問題，這樣我們就能盡可能地回答大家的問題。下一個是誰？

Our next question comes from Jay Olson of Oppenheimer.

我們的下一個問題來自奧本海默公司的傑伊·奧爾森。

Hey, thanks for taking my question. Congrats on the quarter. We're curious about VESALIUS-CV results and how you expect them to impact the overall market opportunity for Repatha? And also, what should we look for in the details when you present them at AHA? And related to that, just any lessons learned that you can apply to olpasiran. Thank you.

嘿，謝謝你回答我的問題。恭喜你本季取得佳績。我們很想了解 VESALIUS-CV 的結果，以及您預計這些結果將如何影響 Repatha 的整體市場機會？另外，當您在 AHA 大會上展示這些內容時，我們應該關注哪些細節？與此相關的，任何可以應用於 olpasiran 的經驗教訓。謝謝。

Jay, I'm glad you're interested and excited about the VESALIUS-CV study. So, we look forward to having a chance to share with you in detail. Maybe two parts. Jay, you want to kick off and then Murdo, you can follow up.

Jay，我很高興你對 VESALIUS-CV 研究感興趣並感到興奮。所以，我們期待有機會與您詳細分享。或許分為兩部分。傑伊，你想先開始，然後默多，你可以接著說。

Yes. Thanks, Jay. Cardiovascular disease is still the number one killer heart attack every 40 seconds in the United States and just about everybody in the world knows about bad cholesterol or LDL-C that Repatha so dramatically lower.

是的。謝謝你，傑伊。心血管疾病仍然是美國頭號殺手，每 40 秒就有一人死於心臟病，世界上幾乎每個人都知道 Repatha 能顯著降低的壞膽固醇或 LDL-C。

And we know that lower is better, yet lipid management globally is still very poorly managed. About 100 million people in the world who are in need of better control. Repatha, so firmly established as accessible, affordable, efficacious in the prevention of recurrent CV events in VESALIUS CV. We asked the really vital important question, can we prevent first events?

我們知道血脂越低越好，但全球血脂管理仍然非常不完善。全世界約有1億人需要更好的控制。Repatha 已在 VESALIUS CV 中被確立為一種易於取得、價格合理、有效預防復發性 CV 事件的藥物。我們提出了一個至關重要的問題：我們能否預防首發事件？

And indeed, this is the first -- the only PCSK9 to demonstrate such an effect. 75% of MIs are first event. And so, it's a really important question. Can't wait to share these data at the upcoming AHA. Importantly, on this study, as Murdo mentioned in the top of the program, this is in addition to optimize lipid management. And so, for patients and doctors on a statin but inadequate LDL-C control, this is a major a major advance.

事實上，這是首例──也是唯一一例──證實存在這種效應的PCSK9基因突變。 75%的心肌梗塞是首次發生。所以，這是一個非常重要的問題。迫不及待在即將召開的美國心臟協會（AHA）年會上分享這些數據。重要的是，正如 Murdo 在節目開頭提到的那樣，這項研究是為了優化血脂管理。因此，對於服用他汀類藥物但 LDL-C 控制不佳的患者和醫生來說，這是一個重大的進展。

We're looking very much forward to sharing the complete results. You asked about lessons learned. They work with great people. The TIMI Group was outstanding. We carry all of the learnings of how to conduct a global study of this incredible span in nature, more than 12,000 patients worldwide. And I think it also serves to emphasize by hitting both dual primary endpoints, just how much room there still is to improve cardiovascular care targeting inflammatory lipo particles. Murdo.

我們非常期待與大家分享完整的結果。你問到了你學到的教訓。他們與優秀的人共事。TIMI集團表現優異。我們掌握瞭如何對這一自然界的驚人跨度進行全球研究的所有經驗，研究對象遍及全球 12,000 多名患者。我認為，透過達到這兩個主要終點，這也強調了針對發炎性脂質顆粒的心血管護理方面還有很大的發展空間。默多。

Well, think you covered most of it, Jay. I would say that if you're not doing anything this weekend and you're really curious, being New Orleans or tuned in. I really -- I think that the word landmark gets thrown around a lot in describing clinical trials, but I don't think it's an inappropriate moniker to put on this one.

嗯，我想你已經涵蓋了大部分內容，傑伊。我想說，如果你這個週末沒什麼安排，而且真的很好奇，那就去新奧爾良看看或關註一下吧。我真的覺得——我覺得「里程碑」這個詞在描述臨床試驗時經常被濫用，但我認為用它來形容這項研究並不為過。

I think this is a substantial advance in understanding how you can prevent first heart attacks and strokes. This is a call to action for primary care physicians everywhere, and we will make sure that immediately after the presentation of these data that our medical teams, our field sales teams, our patient support organizations are out there in full force, making sure that primary care physicians are aware of these data and that patients have the benefit, as Jay said, of an affordable solution that gives them incremental risk reduction beyond any established lipid-lowering therapy on the market today with Repatha.

我認為這是在了解如何預防首次心臟病發作和中風方面取得的重大進展。這是對各地基層醫療醫生的行動號召，我們將確保在這些數據公佈後，我們的醫療團隊、現場銷售團隊和患者支持組織立即全力以赴，確保基層醫療醫生了解這些數據，並確保患者能夠像 Jay 所說的那樣，受益於一種價格合理的解決方案，該方案能夠比目前市場上任何已確立的降脂療法（例如 Repatha）進一步降低風險。

So, it's an exciting time. We've systematically told you all that we were opening up access for Repatha and that we were asking primary care physicians to do more beyond the cardiologist role here, and these data give us yet another opportunity to continue that important work.

所以，這是一個令人興奮的時刻。我們已經有系統地告訴大家，我們正在開放 Repatha 的使用範圍，我們要求初級保健醫生在心臟病專家的角色之外承擔更多責任，而這些數據又給了我們繼續這項重要工作的另一個機會。

And Jay, as we mentioned a couple of times on the call, in our prepared remarks, AmgenNow, obviously, is an important part of the thinking here. We don't want there to be any excuse for anyone not to be able to get access to this at an attractive price relative to the benefit that the medicine provides. So anyway, thanks for asking the question. Let's move on to the next caller.

正如我們在電話會議中多次提到的，在我們的準備好的演講稿中，AmgenNow 顯然是我們思考的重要組成部分。我們不希望任何人因為任何原因無法以與其療效相符的優惠價格獲得這種藥物。總之，謝謝你提出這個問題。我們來接聽下一位來電者。

Matt Phipps, William Blair.

馬特·菲普斯，威廉·布萊爾。

Thanks for taking my questions. The FDA recently released new biosimilar guidance and maybe removing the need for comparative efficacy studies. Wonder if that changes your view at all in the business, maybe some of the barriers to entry, but also the calculus on what biologics might be worth pursuing a biosimilar for.

謝謝您回答我的問題。FDA最近發布了新的生物相似藥指南，可能取消了比較療效研究的要求。不知道這是否會改變您對該行業的看法，也許會改變您對進入市場的某些障礙的看法，以及對哪些生物製劑值得開發生物相似藥的看法。

Thanks, Matt, for the question. I don't think it changes our strategic focus on biosimilars. This has been a very good growth business for Amgen, and we continue to see it as such. Obviously, we pay attention to the new guidance, and our development teams and regulatory teams are very focused on making sure we're ready to adapt to them.

謝謝馬特的提問。我認為這不會改變我們對生物相似藥的戰略重點。對於安進公司來說，這一直是一項成長非常迅猛的業務，我們將繼續這樣認為。顯然，我們非常關注新的指導方針，我們的研發團隊和監管團隊都非常重視確保我們能做好適應這些方針的準備。

I would say that all of the technical functions here at Amgen are in a position to compete effectively regardless of the guidance, whether it's heavy clinical trial requirements or whether it's technical comparability requirements. We've got a great process development team here in our manufacturing operations organization, who continue to do very innovative things in the development of biosimilars, such as helping us be the only biosimilar to EYLEA commercially available on the market. So we think we'll be in good shape. We'll be competitive. And no matter what the guidelines come. Obviously, we'll look closely at them, as I said, and we'll understand how that might impact development of products going forward.

我認為，無論指導方針是嚴格的臨床試驗要求還是技術可比性要求，安進的所有技術職能部門都具備有效參與競爭的能力。我們製造營運部門擁有一支優秀的製程開發團隊，他們在生物相似藥的開發方面不斷進行創新，例如幫助我們成為市場上唯一一款商業化的EYLEA生物相似藥。所以我們認為情況會很好。我們將具備競爭力。無論出台什麼指導方針。正如我所說，我們顯然會仔細研究這些問題，並了解這可能會對未來產品開發產生怎樣的影響。

And just quickly, Matt, at a strategic level, I would observe that there's an undercurrent of question in some quarters, particularly in Washington, about how successful the biosimilar market is in the United States right now as a leading competitor our perspective is the market is performing very well.

馬特，我再簡單說一下，從戰略層面來看，我注意到在某些方面，尤其是在華盛頓，存在著一種暗流湧動的質疑，即目前美國生物相似藥市場的成功程度如何。作為領先的競爭對手，我們的觀點是，該市場表現非常出色。

We think the ground is well set for this to continue to be a flourishing market in the US with patients having access to alternative supplies of important medicines after their patents have expired. And we would we watch carefully to make sure that policies don't emerge that might move this marketplace in the direction of the generic drug industry, where there have been, obviously, a number of abuses that have given rise to quite a bit of anxiety about that market and its impact on patients.

我們認為，在美國，隨著患者在重要藥物專利到期後能夠獲得替代供應，這一市場將繼續蓬勃發展，這方面已經具備了良好的基礎。我們會密切關注，確保不會推出任何可能將市場推向仿製藥行業的政策。顯然，仿製藥行業已經出現了一些濫用行為，引發了人們對該市場及其對患者的影響的相當多的擔憂。

In contrast, we think the biosimilar market is working well. We think regulatory and other policies that are in place today enable that to continue. And we would advocate for again a recognition that the things that are in place now are working well.

相比之下，我們認為生物相似藥市場運作良好。我們認為，現行的監管政策和其他政策能夠使這種情況持續下去。我們再次呼籲大家認識到，目前採取的措施是行之有效的。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great. Thanks so much, maybe just a question for Jay. The second year of the MariTide data is expected by year-end. We know you're looking at three different things. You're looking at the same dose, lower dosing, going to placebo and you're testing Q12 weeks in that study - There's no Q8 weeks. Any sense sort of -- is this going to be in a medical meeting? And can you give us any sense kind of what to really expect and put it in context.

偉大的。非常感謝，我可能想問傑伊一個問題。預計 MariTide 第二年的數據將於年底公佈。我們知道您正在查看三件不同的東西。你看到的是相同劑量、較低劑量、安慰劑，而且這項研究是每 12 週測試一次——沒有每 8 週一次。大概意思是──這是要在醫學會議上進行嗎？您能否大致介紹一下我們應該期待什麼，並將其置於具體的背景中？

Yes. Thanks, Yaron. Part two of the Phase II chronic weight management study is indeed a very interesting study, having achieved strong efficacy in part one, 52 weeks. Part two will contribute a first maintenance experience. And just to remind you the design, as you covered already, we are testing quarterly dosing, full dose.

是的。謝謝你，亞倫。第二階段慢性體重管理研究的確是一項非常有趣的研究，因為第一階段（52 週）已經取得了顯著的療效。第二部分將提供首次維護經驗。再次提醒您設計方案，正如您之前提到的，我們正在測試每季一次的全劑量給藥方案。

We're testing low dose at monthly, and we're comparing these measures to placebo and continued treatment. And these data will be very useful to us. This will inform our maintenance strategy that will provide guidance to additional Phase III designs. And we'll have more to say about our disclosure approach in due course.

我們正在測試每月一次的小劑量治療，並將這些結果與安慰劑和持續治療進行比較。這些數據對我們非常有用。這將為我們的維護策略提供訊息，並為後續的第三階段設計提供指導。關於我們的資訊揭露方式，我們將在適當的時候做更多說明。

Chris Schott, JPMorgan.

克里斯‧肖特，摩根大通。

Hi thanks for taking the question. Is that maybe a bigger picture question on obesity. We've had a number of updates in the space lately. We've got the Metsera headlines going around. We've got some discussions on lower Medicare pricing for obesity drugs.

您好，感謝您回答這個問題。這或許是一個關於肥胖問題的更宏觀層面的問題。最近我們在這個領域進行了一些更新。梅特塞拉的新聞鋪天蓋地而來。我們正在討論降低醫療保險對肥胖症藥物的定價。

I just be interested in just Amgen's latest view on kind of the obesity market and the company's role within the market with MariTide and the broader pipeline. Just the latest kind of lay the land from your perspective.

我只是對安進公司對肥胖症市場的最新看法以及該公司憑藉 MariTide 和更廣泛的產品線在市場中扮演的角色感興趣。這只是從你的角度對現狀進行最新一輪的分析。

Yes. Thanks for the question, Chris. I would say that we are -- we remain very enthusiastic about the opportunity for us in obesity. We believe strongly, as you know, we have a differentiated approach to this market than the competitors that are in the space presently and different from what we see others advancing in their portfolios.

是的。謝謝你的提問，克里斯。我想說，我們仍然對肥胖症領域的機會充滿熱情。如您所知，我們堅信，我們對這個市場採取的方法與目前該領域的競爭對手截然不同，也與我們看到其他人在其投資組合中推進的方法不同。

So again, our interest in this based on everything we know about our molecule and everything we see in the marketplace remains very, very constructive. So, I'll invite Jay and Murdo, I'm sure they'll have thoughts they want to add, Jay, why don't you kick in?

所以，基於我們對該分子的了解以及我們在市場上看到的一切，我們對它的興趣仍然非常非常積極。所以，我會邀請傑伊和默多，我相信他們一定會有一些想法要補充，傑伊，你為什麼不也說說你的看法呢？

Sure. Thanks for the invitation. It's a major public health crisis. Living in the United States, so many people face this every day. Maybe 40% of adults in the United States will have a BMI over 30 and a fifth of children. It's also massively costly to the health care in the United States.

當然。謝謝你的邀請。這是一場重大的公共衛生危機。生活在美國，很多人每天都會面臨這種情況。美國可能有 40% 的成年人和五分之一的兒童的 BMI 指數超過 30。這對美國的醫療保健來說也是一筆龐大的開銷。

The CDC will estimate over $170 billion a year. Murdo can speak to it, but the market is totally underpenetrated implying that health care can significantly improve. But for it to improve, we think it will take really differentiated assets, not just another weekly injectable peptide, which have proven very hard to keep patients on those types of medicines with 55% failure to continue medicines beyond the calendar year.

美國疾病管制與預防中心估計每年損失將超過1700億美元。Murdo可以就此發表意見，但市場滲透率極低，這意味著醫療保健還有很大的提升空間。但我們認為，要改善這種情況，需要真正差異化的資產，而不僅僅是另一種每週注射的勝肽類藥物，事實證明，讓患者堅持服用這類藥物非常困難，55% 的患者在一年後會停止用藥。

And of course, obesity itself as well as the related conditions require much more enduring in chronic therapy. And so we think the MariTide has a fantastic and differentiated profile to contribute there. But as you asked about the broader pipeline, we've been in obesity and metabolic medicine discovery research for more than 20 years.

當然，肥胖本身以及相關疾病需要更持久的慢性治療。因此，我們認為 MariTide 具有極佳且獨特的優勢，能夠為此做出貢獻。但正如您所問，關於更廣泛的研發管線，我們在肥胖症和代謝醫學發現研究領域已經耕耘了 20 多年。

And this pipeline, we have another Phase I asset, AMG 513. And we have preclinical programs advancing. For novel targets within the incretin and non-incretin pathways, some will be oral; some will be injectable. And so, we're really in it to have a huge impact on this major public health crisis. Murdo?

在這條管道上，我們還有另一項一期資產，AMG 513。我們的臨床前計畫正在推進中。對於腸促胰島素和非腸促胰島素路徑中的新靶點，有些是口服的；有些是注射的。因此，我們真的希望對這場重大的公共衛生危機產生巨大影響。默多？

Yes. Thanks, Jay. I mean the only thing I would continue to reinforce for everybody listening in as we continue to feel that MariTide a true differentiation compared to what is available in the market. I mean it is interesting that there's a bidding war between two companies for a GLP-1 that is through some lipid technology enabled potentially to maybe be monthly.

是的。謝謝你，傑伊。我的意思是，對於所有正在收聽的人來說，我唯一想繼續強調的是，我們仍然認為 MariTide 與市場上現有的產品相比，具有真正的差異化優勢。我的意思是，兩家公司正在競購一種 GLP-1，而這種 GLP-1 透過某種脂質技術，有可能實現每月一次的給藥，這確實很有意思。

So, to have a product that's well defined, clearly monthly, perhaps even less frequently in a market, as Jay described, that is massive and undersatisfied, where we hope to go into this market, not just to reduce the weight of patients who struggled with obesity, but also to help deliver on the medical benefit of managing that weight. And I can't wait to see the results of our Phase III program, and I'm really pleased with how the team is executing, look forward to that day. Thank you.

因此，我們希望進入一個市場，正如 Jay 所描述的那樣，一個規模龐大但市場需求遠未得到滿足的市場，推出一款定義明確、每月一次，甚至可能更頻繁的產品，不僅是為了減輕肥胖患者的體重，也是為了幫助他們獲得控制體重的醫療益處。我迫不及待地想看到我們第三階段專案的成果，我對團隊的執行情況非常滿意，期待那一天的到來。謝謝。

Let's go to the next question.

我們來看下一個問題。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO資本市場。

Hi, thanks for taking my question. Bob, your comment kind of on the biosimilar sector struck with me I'm wondering if you could highlight what you think needs to change from a policy perspective to encourage even more uptake of biosimilars. For example, the number one selling adalimumab product is still Humira and not AMJEVITA. How can you, as a biosimilar leader really encourage more use of these products.

您好，感謝您回答我的問題。鮑勃，你對生物相似藥領域的評論讓我印象深刻。我想知道你是否能從政策角度強調你認為需要做出哪些改變才能鼓勵更多人使用生物相似藥。例如，銷售第一的阿達木單抗產品仍然是 Humira，而不是 AMJEVITA。作為生物相似藥的領導者，您如何真正鼓勵更多人使用這些產品？

Yes. Again, I think there's a difference in the US between the Part B medicines and the Part D medicines or the retail and the physician administrative medicines. So, I think market dynamics are evolving differently in those 2 areas. Obviously, the payers are very involved in the Part D where the rebate dynamics are important, but that erodes over time, and I think we see happening that now.

是的。我認為，在美國，B 部分藥品和 D 部分藥品，或零售藥品和醫生處方藥品之間存在差異。所以，我認為這兩個領域的市場動態正在以不同的方式演變。顯然，支付方在 D 部分中扮演著非常重要的角色，因為回扣機制很重要，但隨著時間的推移，這種作用會逐漸減弱，我認為我們現在就看到了這種情況。

Very confident when you look back over the fullness of time, you will see that AMJEVITA or adalimumab biosimilar will have been a very successful product for us. We see that internationally. It continues to be a strong product for us, and I think it will continue to be that. I think, again, in the US, safe, reliable supply of a true biosimilar like ours will do well in the long term.

非常有信心，當你回顧過去，你會發現 AMJEVITA 或阿達木單抗生物相似藥對我們來說將是一款非常成功的產品。我們在國際上也看到了這種情況。它一直是我們非常暢銷的產品，而且我認為它還會繼續保持這種勢頭。我認為，在美國，像我們這樣的真正生物相似藥的安全、可靠的供應，從長遠來看將會有良好的發展前景。

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

This is Mike DiFiore for Umer. Thanks for taking my question. . I just want to go back to the MariTide Phase II trial for a bit. There is some confusion on whether we'll get two-year weight loss data the upcoming Part two readout of the MariTide obesity Phase II trial. So can you clarify the design, especially as it relates to the washout post week 52. And since most of these patients will have lost weight in year one, isn't it reasonable to assume that weight loss in year two Part 2 will be a lot less in year one Part 1.

這是 Mike DiFiore 為 Umer 所做的報導。謝謝您回答我的問題。。我只想再回去看看 MariTide 第二期試驗。關於 MariTide 肥胖症 II 期試驗即將公佈的第二部分結果中是否會提供兩年的減肥數據，目前還存在一些疑問。所以你能解釋一下設計方案嗎，特別是關於第 52 週後的淘汰賽方案。既然大多數患者在第一年都會減輕體重，那麼假設第二年第二部分的體重減輕幅度會比第一年第一部分小得多，這不是合理的嗎？

Yes, Jay, you go ahead.

好的，傑伊，你先來。

I'm happy to answer the question. As I shared, it's principally a maintenance study that tests low dose monthly and full dose quarterly against placebo and continued MariTide target dose. As the study was powered really to inform Phase III, and we derive a significant amount of guidance from Part one.

我很樂意回答這個問題。正如我之前所說，這主要是一項維持性研究，測試每月低劑量和每季全劑量與安慰劑和持續 MariTide 目標劑量的對比情況。由於該研究旨在為 III 期臨床試驗提供信息，而我們從第一部分中獲得了大量的指導。

There are some aspects of Part two that are more descriptive. As you may know that to participate in Part 2, patients had to achieve greater than 15% weight loss in Part 1, and then they were randomized to a number of arms. And the power to make significant insights into weight loss between the arms is not strong, but there will be patients that continue on at their target dose. And as patients in Part 1 did not achieve a weight loss plateau, we'll be interested to follow those patients for the second calendar year.

第二部分有些方面描述得更詳細。您可能知道，要參加第二部分，患者必須在第一部分中減重超過 15%，然後他們將被隨機分配到若干組。雖然我們無法對兩臂之間的體重減輕情況做出重大評價，但仍會有患者堅持服用目標劑量。由於第一部分的患者沒有達到體重減輕的平台期，我們將有興趣在第二年繼續追蹤這些患者。

And just to be clear there, Jay, when you say the power is not strong. I mean, it's not designed numerically, it's not designed for that purpose.

傑伊，我得把話說清楚，你說電力不強。我的意思是，它不是按數值設計的，它不是為了那個目的而設計的。

That's right. This as I’ve shared is a study that's designed to inform our strategy on maintenance MariTide as well as further Phase III programming, and we fully expect to derive all the information needed from Part two of the study for those purposes.

這是正確的。正如我之前分享的，這項研究旨在為我們制定 MariTide 維護策略以及進一步的 III 期規劃提供信息，我們完全期望從該研究的第二部分中獲得實現這些目的所需的所有信息。

Again, I'm mindful we're getting up to half past the hour. So, we'll take two more questions, and I apologize to the rest of you we're available for calls later in the day.

我再次提醒大家，現在已經快過半點了。那麼，我們再回答兩個問題，向其他各位致歉，我們今天晚些時候會接聽電話。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Hey thanks. I got a UPLIZNA specific question. So, you're seeing pretty strong performance in the wake of the label expansion in IgG4-related disease. Can you talk to the extent to which there's been pent-up demand here? Give us your refreshed views on the sales opportunity here? And then I guess beyond that with the gMG label expansion, how are you thinking about rapidity of uptake there, given that that's a more competitive landscape and there some competitive dynamics to consider in gMG.

謝謝。我收到一個關於UPLIZNA的具體問題。因此，隨著 IgG4 相關疾病標籤的擴大，我們看到了相當強勁的業績。您能談談這裡存在多大程度的積壓需求嗎？請分享您對此次銷售機會的最新看法？然後，我想，除了 gMG 標籤的擴展之外，您如何看待那裡的普及速度？考慮到這是一個競爭更加激烈的領域，gMG 中存在一些競爭動態需要考慮。

We'll try to get it efficiently for you here. But I think, Murdo, I'm sure you're going to want to have say a few things about the exciting dynamic we see for UPLIZNA.

我們會盡快幫您有效率地獲取。但我認為，默多，我確信你肯定想就我們看到的UPLIZNA令人興奮的發展勢頭髮表一些看法。

Yes. Thanks for the question, David. Obviously, we're very early in the IgG4 launch. As I mentioned, we've got roughly 300 unique prescribers that have prescribed UPLIZNA for IgG4. I'm not sure I would characterize it as pent-up demand. IgG4 is a disease that really only got its own ICD-10 code in 2023.

是的。謝謝你的提問，大衛。顯然，我們目前還處於 IgG4 上市的早期階段。正如我之前提到的，大約有 300 位不同的處方醫生開立了 UPLIZNA 用於治療 IgG4 感染。我不太確定是否應該將其描述為被壓抑的需求。IgG4 是一種直到 2023 年才真正擁有自己的 ICD-10 代碼的疾病。

So, this is a patient that often presents without an obvious diagnosis on the part of the physician. We're actually seeing awareness, our education and the fact that we've got the only FDA approved treatment for IgG4 as a catalyst for even more growth.

因此，這類患者通常無法得到醫師的明確診斷。實際上，我們看到人們的意識提高、我們的教育以及我們擁有唯一獲得 FDA 批准的 IgG4 治療藥物這一事實，都成為了推動更大增長的催化劑。

The estimate is about 20,000 patients in the US, but as I mentioned, given that the diagnostic codes are relatively new here, the actual market could be much bigger. We have obviously demonstrated overwhelming efficacy when you can reduce flares by as much as 87% substantial reduction in steroids and really have patients who are in significant trouble here,have their disease resolved and have their flares reduced as a very important therapy. So, it's helped us a lot.

據估計，美國約有 20,000 名患者，但正如我所提到的，鑑於診斷代碼在這裡相對較新，實際市場可能要大得多。我們已經明顯證明了其巨大的療效，可以將病情發作減少高達 87%，大幅減少類固醇用量，並且確實有一些病情非常嚴重的患者，他們的疾病得到了緩解，病情發作也得到了減少，這是一種非常重要的治療方法。所以，它對我們幫助很大。

Jay will want to expand further on that. But before I turn it to him, I'd just say that in NMOSD, we expect to have a strong -- sorry, in gMG, we expect to have a strong presence in that market, given the profile that we were able to show in the MINT trial.

傑伊會想就此展開進一步的討論。但在我把這個問題轉給他之前，我只想說，在 NMOSD 領域，鑑於我們在 MINT 試驗中展現出的實力，我們預計在該市場將佔據強大的地位——抱歉，是在 gMG 領域，我們預計在該市場將佔據強大的地位。

We've got a very convenient dosing here after the first loading dose, you get to twice a year of therapy, a very durable effect, perhaps more durable than some of the agents that are in the market today. And given that the data are already out there, there we have some real interest on the part of the people who are treating the gMG patient population.

我們這裡有一種非常方便的給藥方式，在第一次負荷劑量後，您可以每年接受兩次治療，效果非常持久，可能比目前市面上的一些藥物更持久。鑑於相關數據已經公佈，治療重症肌無力患者的人對此表現出了濃厚的興趣。

The other thing to think about in gMG is there's a lot of switching between treatments and between classes of therapy. Usually, a patient is on a primary therapy for no longer than a year to 1.5 years and they see at least two medications, sometimes as many as three medications until they feel stabilized. So, it is a market that's still dissatisfied despite the number of entrants. Jay?

重症肌無力患者需要考慮的另一點是，治療方案和治療類別之間經常需要轉換。通常情況下，患者接受主要治療的時間不會超過一年到一年半，並且至少需要服用兩種藥物，有時甚至需要服用多達三種藥物，直到病情穩定為止。所以，儘管進入市場的企業數量眾多，但市場仍然不滿意。傑伊？

Yes. Thanks, Murdo. I think the differentiation is really strong, as Murdo shared. I think it's attributable to targeting the core disease biology. I mean targeting the CD19 positive cell is really the entirety of the B-cell compartment, not just the mature cells, but also the immature cells that start to elaborate the auto antibodies.

是的。謝謝你，默多。正如默多所說，我認為這種差異化非常明顯。我認為這歸功於針對疾病核心生物學機制的治療。我的意思是，標靶 CD19 陽性細胞其實就是整個 B 細胞區室，不僅是成熟細胞，還包括開始產生自體抗體的未成熟細胞。

And because of this, although it's always hard to make trial to trial comparisons, we see numerically higher efficacy by MG-ADL, which is a standard measure. We see more steroid sparing than FcRn. We see incredible durability, as Murdo said, during the randomized control period and a serious dosing advantage with six months dosing after the loading dose.

正因如此，儘管進行試驗間的比較總是很困難，但我們透過 MG-ADL（一種標準測量方法）看到了數值上更高的療效。我們發現類固醇的使用比 FcRn 更普遍。正如 Murdo 所說，我們在隨機對照期內看到了令人難以置信的耐久性，並且在負荷劑量後六個月的給藥中看到了明顯的劑量優勢。

And so durable, sustained efficacy are not just promising for gMG, but more broadly, to the other diseases that are driven by pathologic (auto-antibodies). And as you might know, we have open studies of inebilizumabas well as blinatumomab in autoimmunity that are open and enrolling in a very dynamic and exciting space where CD19 medicines of many classes are showing profound activity in severe advanced autoimmune diseases, and we, of course, have two in-market brands. So, we're in a good spot to take advantage of this opportunity to help these patients.

因此，持久、持續的療效不僅對重症肌無力（gMG）有前景，而且更廣泛地說，對其他由病理驅動的疾病也有前景。（自體抗體）正如您可能知道的那樣，我們針對自體免疫疾病進行了 inebilizumaba 和 blinatumomab 的開放性研究，這些研究正在進行中，並招募患者。這是一個非常活躍和令人興奮的領域，許多類別的 CD19 藥物在嚴重的晚期自體免疫疾病中顯示出顯著的活性，當然，我們有兩個已上市的品牌。所以，我們處於一個有利位置，可以抓住這個機會幫助這些患者。

Dave Risinger, Leerink Partners.

Dave Risinger，Leerink Partners。

Thanks very much. I was just hoping that you could maybe just call out the top two or three pipeline cards that are turning over that could be most impactful for Amgen in the next 6 to 12 months that we should be focused on. Thanks very much.

非常感謝。我只是希望您能指出未來 6 到 12 個月內對安進影響最大的兩到三個最重要的銷售管道，以便我們可以專注於。非常感謝。

Jay, do you want to go ahead and talk about a couple of things that you're watching carefully.

傑伊，你想不想談談你正在密切關注的幾件事？

Yes. Well, I'm obviously very excited in this moment about VESALIUS-CV, which we're going to be sharing in just a week. And so, I really quite encourage you to pay close attention to this. The further development of IMDELLTRA and tarlatamab is also very exciting.

是的。嗯，我現在當然對 VESALIUS-CV 感到非常興奮，我們將在一周後與大家分享它。因此，我強烈建議你們密切注意這一點。IMDELLTRA 和 tarlatamab 的進一步研發也令人非常興奮。

We see very dramatic activity in the cases that are now being communicated back to us if patients save from impossible situations, as I shared, is very powerful. And as we've learned from blinatumomab moving tarlatamab, Imdelltra into combination therapy into frontline use into a setting where there could be less active disease owing to the debulking of chemo, all promises, as we've seen in this dramatic 303 study presented at World Lung as well as at ESMO for really meaningful activity in frontline in Phase III. And this is one of those moments, David, where time just can't move fast enough to read out those Phase III studies.

我們看到，如果患者能夠從不可能的情況下獲救，正如我剛才所說，那將是非常強大的，而現在反饋給我們的病例中，我們看到了非常顯著的積極作用。正如我們從 blinatumomab 到 tarlatamab、Imdelltra 的聯合療法中所了解到的，這些療法被引入一線治療，用於化療減瘤後疾病活動性可能較低的情況，所有這些都很有希望，正如我們在世界肺臟大會和 ESMO 上公佈的這項治療中引人注目的 303 研究中看到的那樣，在 III 期真正有意義的治療中取得了真正有意義的治療。大衛，現在就是這樣的時刻，時間過得太慢，我們根本來不及看完那些 III 期研究報告。

We had an opportunity here before the call, Dave, to see some PET scan data on a patient who's in tough shape, who is experiencing quite a profound response to the medicine. So it's a medicine that we're excited about. I think somebody at ESMO described it as WOW Squared. So stay tuned. We're hopeful about the data that's forthcoming on IMDELLTRA platform here over time.

戴夫，在通話之前，我們有機會查看了一位病情嚴重的患者的 PET 掃描數據，這位患者對藥物的反應非常顯著。所以，我們對這種藥物感到非常興奮。我記得ESMO大會上有人形容它是「WOW平方」。敬請期待。我們對IMDELLTRA平台未來將提供的資料抱持著希望。

All right. Well, thank you all for your attention and for joining the call. Casey and his team will be available through the afternoon and evening if anybody didn't get a chance to raise a question that they have an interest in. We look forward to being with you after the next quarter. Thanks.

好的。感謝各位的關注與參與通話。如果有人沒機會提出自己感興趣的問題，凱西和他的團隊將在下午和晚上隨時提供協助。我們期待在下一季之後繼續與您合作。謝謝。

This concludes our Amgen Q3 2025 earnings conference call. You may now disconnect.

安進公司2025年第三季財報電話會議到此結束。您現在可以斷開連線了。