美國安進 (AMGN) 2025 Q2 法說會逐字稿

My name is Julianne, and I will be your conference facilitator today for the Amgen Q2 FY 2025 earnings conference call. (Operator Instructions)

我叫朱莉安，今天我將擔任安進 2025 財年第二季財報電話會議的主持人。（操作員指示）

I would now like to introduce Justin Claeys, Vice President of Investor Relations. Mr. Claeys, you may now begin

現在我想介紹投資者關係副總裁賈斯汀·克萊斯 (Justin Claeys)。克萊斯先生，你現在可以開始

Good afternoon, everyone, and welcome to our second quarter 2025 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner and Peter Griffith. 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.

大家下午好，歡迎參加我們 2025 年第二季財報電話會議。鮑勃·布拉德威 (Bob Bradway) 將主持電話會議，隨後默多·戈登 (Murdo Gordon)、傑伊·布拉德納 (Jay Bradner) 和彼得·格里菲斯 (Peter Griffith) 對我們的表現進行更廣泛的回顧。在今天的討論過程中，我們將使用非公認會計準則財務指標來描述我們的業績，並在本次電話會議隨附的資料中提供適當的對帳。我們也將做出一些符合我們的安全港聲明的前瞻性陳述，請注意實際結果可能會發生重大差異。

Over to you, Bob.

交給你了，鮑伯。

Good afternoon, everyone, and thank you for joining us today. As you'll hear, Amgen delivered another strong quarter, driven by growing demand for our medicines across the board. With net selling prices for medicines declining across the industry, volume growth is a key differentiator. And once again, this quarter, that's what we delivered. We did this, of course, while also advancing a world-class pipeline. In the quarter, revenues grew by 9% year-over-year and volume increased at an impressive 13%. 15 of our products delivered at least double-digit sales growth, demonstrating the breadth and depth of our portfolio.

大家下午好，感謝大家今天的參與。正如您所聽到的，由於我們藥品的需求全面增長，安進又一個季度表現強勁。隨著整個產業藥品淨售價的下降，銷售成長成為關鍵的區別因素。本季我們再次實現了這個目標。當然，我們在這樣做的同時，也推進了世界一流的管道建設。本季度，營收年增9%，銷量更是大幅成長13%。其中15款產品實現了至少兩位數的銷售成長，彰顯了我們產品組合的廣度與深度。

As you're all aware, there's a focus on pricing and tariffs in our industry. And I would just say that we are actively engaged in discussions with our government officials and share the objectives of improving patient access, affordability and expanding biopharma manufacturing in the US. We believe the world needs more innovation, not less, and we're continuing to invest heavily in innovation to support long-term growth. We're, of course, doing that while building on a track record of success, including multiple Phase 3 readouts in the first half of 2025.

眾所周知，我們行業關注的是定價和關稅。我想說的是，我們正在積極與政府官員進行討論，並共同致力於改善患者的可及性、可負擔性和擴大美國生物製藥製造業。我們相信世界需要更多的創新，而不是更少的創新，我們將繼續大力投資創新以支持長期成長。當然，我們這樣做的同時也累積了成功的記錄，包括 2025 年上半年的多次第三階段讀數。

We also believe that AI will be additive to the innovative capacity of our industry, and we feel we remain well positioned to accelerate progress through the convergence of biotech and technology, including the application of AI across the company.

我們也相信人工智慧將增強我們行業的創新能力，我們認為我們仍然有能力透過生物技術和技術的融合來加速進步，包括在整個公司範圍內應用人工智慧。

Let me turn to a few key drivers behind this quarter's momentum. I'll remind you that we're focused in four areas, and each are performing well.

讓我來談談本季發展勢頭背後的幾個關鍵驅動因素。我要提醒大家的是，我們專注在四個領域，每個領域都表現良好。

In General Medicine, we're reaching large underserved patient populations with multiple products that have significant room for growth. For example, in cardiovascular disease and bone health. In addition, our obesity pipeline programs are advancing broadly.

在普通醫學領域，我們透過多種具有巨大成長空間的產品覆蓋大量服務不足的患者群體。例如心血管疾病和骨骼健康。此外，我們的肥胖症治療計畫正在廣泛推進。

In rare disease, we have four key growth drivers which are all early in their life cycles and well positioned for robust long-term growth, with attractive pipeline molecules following closely behind. In inflammation, where we've enjoyed decades of leadership, we're excited about the progress we're seeing in difficult-to-treat diseases where innovation is most needed.

在罕見疾病領域，我們有四個關鍵的成長動力，它們都處於生命週期的早期，並且能夠實現長期的強勁增長，而有吸引力的研發管線分子則緊隨其後。在發炎領域，我們已享有數十年的領先地位，我們對在最需要創新的難治疾病方面取得的進展感到興奮。

In oncology, we're delivering therapies that are redefining standards of care and changing what patients can expect from treatment. Our industry-leading biosimilars portfolio continues to contribute meaningful growth as well. And we've proven to be a leading competitor in this field, and it remains an attractive area for us.

在腫瘤學領域，我們提供的治療方法正在重新定義護理標準並改變患者對治療的期望。我們行業領先的生物相似藥產品組合也繼續帶來有意義的成長。事實證明，我們是該領域的領先競爭者，而該領域對我們來說仍然是一個有吸引力的領域。

To close, this was an exciting quarter, not just because of the financial results, but because of what it signals about Amgen's future. In-line brands are delivering. We're launching new products, and we're advancing the next wave of late-stage programs. Amgen is well positioned to deliver innovation and growth not just this year, but for the long term. And I want to thank our colleagues around the world for their dedication to our mission to serve patients.

總而言之，這是一個令人興奮的季度，不僅因為財務業績，還因為它預示著安進的未來。同線品牌正在交付產品。我們正在推出新產品，並正在推進下一波後期專案。安進不僅在今年，而且在長期內都已做好準備實現創新和成長。我還要感謝世界各地的同事們對我們為病人服務的使命的奉獻。

With that, let me turn it over to Murdo for an update on the commercial progress in the quarter.

接下來，請容許我向 Murdo 介紹本季商業進展的最新情況。

Thanks, Bob. In the second quarter, sales increased 9% year-over-year, driven by 13% volume growth. As you heard from Bob, 15 products delivered double-digit or better growth, a clear demonstration of the strength of our portfolio and quality of our execution.

謝謝，鮑伯。第二季度，銷售額年增 9%，其中銷量成長 13%。正如鮑伯所說，15 種產品實現了兩位數或更高的成長，這清楚地證明了我們產品組合的實力和執行的品質。

Turning to General Medicine. Repatha delivered $696 million in the second quarter, up 31% year-over-year. Improved access is enabling more patients to benefit from Repatha with an estimated 100 million people in need of effective LDL-C lowering, the opportunity to expand our impact remains substantial.

轉向普通醫學。Repatha 第二季的營收為 6.96 億美元，較去年同期成長 31%。改善的獲取途徑使更多的患者能夠從 Repatha 中受益，預計有 1 億人需要有效降低 LDL-C，擴大我們影響力的機會仍然很大。

In the US, we saw continued demand growth across both cardiology and primary care, supported by an expanding prescriber base and deepening engagement across key customer segments. Our direct-to-consumer campaign continues to make a positive impact, with more patients actively asking their doctors about Repatha. On pricing, we expect less net price erosion than we've experienced historically.

在美國，我們看到心臟病學和初級保健的需求持續增長，這得益於不斷擴大的處方者基礎和關鍵客戶群不斷加深的參與。我們的直接面向消費者的活動持續產生正面影響，越來越多的患者主動向醫生詢問有關 Repatha 的資訊。在定價方面，我們預期淨價格的下降幅度將比歷史上小。

EVENITY sales increased 32% year-over-year to $518 million in the second quarter. In the US, EVENITY grew 41% with increased prescription volume from both established and newly activated prescriber accounts. In Japan, EVENITY is positively impacting many people, with over 700,000 patients treated since launch. As the only therapy that both builds bone and slows bone loss, EVENITY is uniquely positioned to reduce fracture risk in women who are postmenopausal.

EVENITY 第二季銷售額年增 32%，達到 5.18 億美元。在美國，EVENITY 成長了 41%，現有和新啟動的處方帳戶的處方量均有所增加。在日本，EVENITY 對許多人產生了積極影響，自推出以來已有超過 70 萬名患者得到治療。EVENITY 作為唯一一種既能增強骨骼又能減緩骨質流失的療法，在降低停經後女性骨折風險方面具有獨特的優勢。

Approximately 250,000 patients in the US have been treated with EVENITY today. However, many remain at high risk of fracture, with about 90% of the roughly 2 million very high-risk patients still not receiving appropriate therapy. This represents a meaningful opportunity to drive growth by ensuring more patients receive the protection they need from EVENITY.

目前，美國約有 25 萬名患者接受了 EVENITY 治療。然而，許多人仍面臨較高的骨折風險，約 200 萬名極高風險患者中約 90% 仍未接受適當的治療。這是一個有意義的機會，透過確保更多患者從 EVENITY 獲得所需的保護來推動成長。

Prolia sales declined 4% year-over-year in the second quarter to $1.1 billion, driven by lower net selling price. In the US, three biosimilars have now launched. And while it remains early, initial market dynamics are unfolding in line with our expectations.

由於淨售價下降，Prolia 第二季銷售額年減 4% 至 11 億美元。在美國，目前已有三種生物相似藥上市。雖然現在還為時過早，但初步的市場動態正按照我們的預期展開。

I'll move to our rare disease portfolio, which grew 19% year-over-year, delivering nearly $1.4 billion in sales in the quarter and now annualizing at over $5 billion. TEPEZZA grew 5% in the quarter to $505 million in sales. Since launch, TEPEZZA has had a positive impact for thousands of patients living with thyroid eye disease.

我將轉到我們的罕見疾病產品組合，該產品組合年增 19%，本季銷售額接近 14 億美元，年銷售額目前超過 50 億美元。TEPEZZA 本季銷售額成長 5%，達到 5.05 億美元。自推出以來，TEPEZZA 已為數千名患有甲狀腺眼疾的患者帶來了正面影響。

We're continuing our efforts to engage a broad prescriber base of oculoplastic surgeons, ophthalmologists and endocrinologists, and we're encouraged by the feedback we're receiving from the medical community, including an increase in intent to prescribe reported by endocrinologists during the second quarter. We launched TEPEZZA in Japan in December, and we're happy with the progress to date.

我們正在繼續努力，吸引眼整形外科醫生、眼科醫生和內分泌科醫生等廣泛的處方者，我們對來自醫學界的反饋感到鼓舞，包括第二季度內分泌科醫生報告的處方意向有所增加。我們於 12 月在日本推出了 TEPEZZA，我們對迄今為止的進展感到滿意。

UPLIZNA sales increased 91% year-over-year to $176 million in the second quarter. UPLIZNA continues to be the number one prescribed FDA-approved treatment for NMOSD. UPLIZNA growth is also bolstered by the FDA approval in April for use in IgG4-related disease. Our launch in IgG4-related disease is going well, with strong uptake amongst rheumatologists and key academic medical centers. Additionally, launch preparations are underway for the anticipated approval of UPLIZNA for use in generalized myasthenia gravis or chronic autoimmune neuromuscular disorder.

UPLIZNA 第二季銷售額年增 91%，達到 1.76 億美元。UPLIZNA 繼續成為 FDA 批准的治療 NMOSD 的首選藥物。今年 4 月，FDA 批准 UPLIZNA 用於治療 IgG4 相關疾病，這也促進了 UPLIZNA 的成長。我們在 IgG4 相關疾病領域的研發進展順利，並得到了風濕病學家和主要學術醫療中心的廣泛認可。此外，UPLIZNA 預計將獲得批准用於治療全身性重症肌無力或慢性自體免疫神經肌肉疾病，上市準備工作正在進行中。

We look forward to the potential to bring UPLIZNA to patients living with gMG who can benefit from UPLIZNA's differentiated profile, including its durable efficacy over time and convenient dosing and administration.

我們期待將 UPLIZNA 帶給患有 gMG 的患者，他們可以從 UPLIZNA 的差異化特性中受益，包括其持久的療效以及方便的劑量和給藥方式。

Moving to inflammation. TEZSPIRE delivered another strong quarter with sales up 46% year-over-year to $342 million. Adoption of biologic agents in severe asthma has accelerated meaningfully over the past five years, almost doubling as physicians increasingly recognize the value of these treatments. Yet with US biologic penetration still under 25%, there remains substantial opportunity for continued growth.

轉向炎症。TEZSPIRE 又一個季度表現強勁，銷售額年增 46%，達到 3.42 億美元。過去五年來，生物製劑在治療嚴重氣喘方面的應用顯著加快，隨著醫生越來越認識到這些治療的價值，應用量幾乎翻了一番。然而，由於美國生物製劑滲透率仍低於 25%，因此仍有巨大的持續成長機會。

TEZSPIRE not only helped expand the category, but continues to grow faster than the market, gaining share from legacy products based on its differentiated and broadly applicable profile to treat patients with multiple triggers and drivers of severe uncontrolled asthma.

TEZSPIRE 不僅幫助擴大了產品類別，而且繼續以高於市場的速度成長，憑藉其差異化和廣泛適用的特性，從傳統產品中獲取市場份額，用於治療患有多種誘因和驅動因素的嚴重不受控制的氣喘患者。

Our innovative oncology portfolio, which includes BLINCYTO, IMDELLTRA, LUMAKRAS, Vectibix, KYPROLIS, Nplate and XGEVA grew 14% year-over-year, generating $2.2 billion of sales in the quarter. At the core of this growth is our industry-leading bispecific T cell engager or BiTE platform, which led to the discovery of both IMDELLTRA and BLINCYTO. With these products, we're helping to redefine the standard of care and improve overall survival rates in difficult-to-treat cancers, creating meaningful opportunities to reach more patients and drive long-term growth.

我們的創新腫瘤學產品組合包括 BLINCYTO、IMDELLTRA、LUMAKRAS、Vectibix、KYPROLIS、Nplate 和 XGEVA，較去年同期成長 14%，本季銷售額達 22 億美元。這一成長的核心是我們業界領先的雙特異性 T 細胞接合器或 BiTE 平台，該平台促成了 IMDELLTRA 和 BLINCYTO 的發現。透過這些產品，我們正在幫助重新定義護理標準並提高難治癌症的整體存活率，創造有意義的機會來接觸更多的患者並推動長期成長。

Our US launch of IMDELLTRA for the treatment of patients with extensive stage small cell lung cancer who are progressing on or after chemotherapy continues to build momentum, generating $134 million in sales in the second quarter.

我們在美國推出的用於治療化療期間或化療後病情進展的廣泛期小細胞肺癌患者的 IMDELLTRA 繼續保持強勁勢頭，第二季度的銷售額達到 1.34 億美元。

We see strong conviction in IMDELLTRA as a standard of care in second line small cell lung cancer. IMDELLTRA is being administered broadly across sites of care, including academic cancer centers, regional cancer hospitals and community oncology clinics. Over half of all IMDELLTRA doses are now administered in the community setting, indicating growing comfort with this important new cancer therapy.

我們堅信 IMDELLTRA 是治療二線小細胞肺癌的標準療法。IMDELLTRA 廣泛應用於各個醫療機構，包括學術癌症中心、地區癌症醫院和社區腫瘤診所。目前，超過一半的 IMDELLTRA 劑量都是在社區環境中施用的，這表明人們對這種重要的新型癌症療法越來越感到滿意。

BLINCYTO grew 45% year-over-year to $384 million in sales, driven by broad prescribing across both academic and community segments. In the US, recent updates to the NCCN guidelines position BLINCYTO as a preferred consolidation therapy in combination with continued multi-agent chemotherapy for both adults and pediatric patients with Philadelphia chromosome-negative B-cell ALL.

BLINCYTO 的銷售額年增 45%，達到 3.84 億美元，這得益於學術界和社區領域廣泛的處方。在美國，NCCN 指南的最新更新將 BLINCYTO 定位為費城染色體陰性 B 細胞 ALL 成人和兒童患者的首選鞏固療法，與持續多藥化療相結合。

In the second quarter, biosimilar portfolio sales grew 40% year-over-year to $661 million. Since the first launches in 2018, our biosimilars have delivered almost $12 billion in sales, representing a significant contributor to top line growth and generating meaningful cash flows.

第二季度，生物相似藥產品組合銷售額年增 40%，達到 6.61 億美元。自 2018 年首次推出以來，我們的生物相似藥已實現近 120 億美元的銷售額，為營收成長做出了重要貢獻，並產生了可觀的現金流。

Within this portfolio, our launch of PAVBLU, a biosimilar to EYLEA, continues to gain momentum, reaching $130 million in the second quarter. Retina specialists are responding very positively to PAVBLU, expressing appreciation for this high-quality Amgen biosimilar delivered in an easy-to-use prefilled syringe.

在這個產品組合中，我們推出的 EYLEA 生物相似藥 PAVBLU 繼續保持成長勢頭，第二季達到 1.3 億美元。視網膜專家對 PAVBLU 的反應非常積極，並對這種透過易於使用的預充式註射器輸送的高品質安進生物仿製藥表示讚賞。

I'm very pleased with our performance in the second quarter, powered by life-changing medicines, disciplined execution and a clear and enduring commitment to the patients we serve.

我對我們第二季度的業績感到非常滿意，這得益於改變生活的藥物、嚴格的執行以及對我們服務的患者明確而持久的承諾。

And now I'd like to hand it over to Jay.

現在我想把發言權交給傑伊。

Thank you, Murdo, and good afternoon, everyone. The second quarter marked a period of strong momentum and execution across the R&D pipeline. We delivered high-quality rapid progress advancing multiple late-stage programs.

謝謝你，Murdo，大家下午好。第二季標誌著整個研發流程動能強勁、執行力十足的時期。我們在推進多個後期專案方面取得了高品質、快速的進展。

Starting with MariTide, our investigational therapy for obesity and obesity-related conditions. In June, data were presented at the ADA and simultaneously published in the New England Journal of Medicine.

從 MariTide 開始，這是我們針對肥胖和肥胖相關疾病的研究療法。6 月份，數據在 ADA 上公佈，並同時發表在《新英格蘭醫學雜誌》上。

Let me highlight some of the key points that define the differentiated profile of MariTide for the treatment of obesity and obesity-related conditions. MariTide is convenient, the most advanced obesity treatment in development with monthly or less frequent dosing. Efficacy is strong, with up to approximately 20% weight loss at 52 weeks without a plateau and with a clinically meaningful improvement in cardiometabolic parameters, including hemoglobin A1C.

讓我重點介紹 MariTide 在治療肥胖症和肥胖相關疾病方面的差異化特徵的一些關鍵點。MariTide 是一種方便的、正在開發的最先進的肥胖症治療方法，只需每月或更少次服用即可。療效顯著，52 週內體重減輕高達約 20%，且無平台期，心臟代謝參數（包括糖化血紅素 A1C）有臨床意義上的改善。

MariTide is safe, very well tolerated at target doses. We've significantly improved GI tolerability with dose escalation without compromising weight loss efficacy. The Phase 3 program is underway, well informed by prior data and utilizing a refined three-step dose escalation approach to optimize tolerability. Enrollment momentum for chronic weight management is strong across multiple geographies, reflecting broad investigator enthusiasm, participate interest in these trials and significant remaining unmet need.

MariTide 是安全的，在目標劑量下耐受性非常好。我們透過增加劑量顯著改善了胃腸道耐受性，同時又不影響減肥效果。第三階段計劃正在進行中，該計劃充分參考了先前的數據，並利用改進的三步驟劑量遞增方法來優化耐受性。慢性體重管理的招募勢頭在多個地區都很強勁，反映了研究人員的廣泛熱情、參與者對這些試驗的興趣以及大量未滿足的需求。

Since June, we initiated two additional Phase 3 studies. The first, MariTide CV evaluates cardiovascular outcomes in adults living with atherosclerotic cardiovascular disease and obesity or overweight. The second, MariTide HF, evaluates reduction of heart failure events and cardiovascular risk in adults living with heart failure with a preserved or mildly reduced ejection fraction and obesity.

自六月以來，我們啟動了另外兩項第三階段研究。第一個，MariTide CV 評估患有動脈粥狀硬化性心血管疾病和肥胖或超重的成年人的心血管結果。第二項研究 MariTide HF 評估了患有心臟衰竭且射血分數維持或輕度降低和肥胖的成年人的心臟衰竭事件和心血管風險的減少情況。

In summary, MariTide represents a promising treatment advance for people living with obesity, obesity-related conditions and type 2 diabetes. With four Phase 3 studies underway and obstructive sleep apnea set to initiate this year, we are well positioned to deliver a robust and comprehensive clinical knowledge base.

總之，MariTide 代表著肥胖症、肥胖相關疾病和 2 型糖尿病患者的一種有希望的治療進步。隨著四項 3 期研究正在進行中，阻塞性睡眠呼吸中止症研究也將於今年啟動，我們已準備好提供強大而全面的臨床知識庫。

Beyond MariTide, in General Medicine, we remain excited about data from the Repatha VESALIUS Phase 3 primary prevention study expected later this year.

除了 MariTide 之外，在普通醫學領域，我們仍然對預計今年稍後進行的 Repatha VESALIUS 第 3 階段一級預防研究的數據感到興奮。

Turning to olpasiran, our promising best-in-class small-interfering RNA medicine targeting LP(a), the fully enrolled event-driven OCEAN(a) Phase 3 cardiovascular outcome study continues to mature. This medicine and study reflects our precision missing approach to cardiovascular risk reduction in patients with elevated Lp(a) levels.

談到奧帕西蘭，我們前景光明的針對 LP(a) 的一流小幹擾 RNA 藥物，目前已完全入組事件驅動的 OCEAN(a) 第 3 期心血管結果研究正在不斷成熟。這種藥物和研究反映了我們對降低 Lp(a) 水平升高患者心血管風險的精準缺失方法。

Moving on to our rare disease portfolio. In UPLIZNA, we look forward to the upcoming December 14 PDUFA date for generalized myasthenia gravis, recognizing ever more, the significant unmet need for durable, convenient therapies consistently highlighted to us by treating physicians. We are pleased by the European Commission's approval of TEPEZZA for the treatment of adults with thyroid eye disease.

接下來介紹我們的罕見疾病組合。在 UPLIZNA，我們期待即將到來的 12 月 14 日全身性重症肌無力 PDUFA 日期，並更加認識到治療醫生不斷向我們強調的對持久、便捷療法的巨大未滿足需求。我們很高興看到歐盟委員會批准 TEPEZZA 用於治療成人甲狀腺眼疾。

Additionally, enrollment is complete in our Phase 3 study examining subcutaneous administration of teprotumumab, representing another step forward towards improved patient convenience and treatment accessibility.

此外，我們針對皮下注射 teprotumumab 的 3 期研究的招募工作已經完成，這代表我們在改善患者便利性和治療可及性方面又邁出了一步。

In inflammation, our two Phase 3 studies of TEZSPIRE in chronic obstructive pulmonary disease continue to enroll patients with moderate to very severe COPD with blood eosinophil counts greater or equal to 150 cells per microliter. Beyond COPD, enrollment was recently completed in our Phase 3 eosinophilic esophagitis study, and we look forward to the October 19 PDUFA date for TEZSPIRE in chronic rhinosinusitis with nasal polyps.

在發炎方面，我們對 TEZSPIRE 治療慢性阻塞性肺病的兩項 3 期研究繼續招募血液嗜酸性粒細胞計數大於或等於每微升 150 個細胞的中度至重度 COPD 患者。除了 COPD 之外，我們最近還完成了 3 期嗜酸性食道炎研究的招募，我們期待 10 月 19 日 TEZSPIRE 在治療伴有鼻息肉的慢性鼻竇炎方面的 PDUFA 日期。

Moving to oncology. In June, interim results from the global Phase 3 DeLLphi-304 trial of IMDELLTRA, the first and only FDA-approved delta-like ligand three or DLL3 targeting BiTE molecule, were presented and simultaneously published in the New England Journal of Medicine. These compelling data showed IMDELLTRA significantly reduced the risk of death by 40% and significantly extended median overall survival by more than five months compared to standard of care chemotherapy in patients with small cell lung cancer who progressed on or after one line of platinum-based therapy.

轉向腫瘤學。6 月，IMDELLTRA（首個也是唯一一個獲得 FDA 批准的 delta 樣配體三或 DLL3 靶向 BiTE 分子）的全球 3 期 DeLLphi-304 試驗的中期結果在《新英格蘭醫學雜誌》上公佈並同時發表。這些令人信服的數據表明，對於接受一線鉑類療法治療期間或之後病情進展的小細胞肺癌患者，與標準化療相比，IMDELLTRA 可顯著降低死亡風險 40%，並將中位總生存期顯著延長五個月以上。

Additionally, IMDELLTRA significantly improved patient reported outcomes of dyspnea and cough and was numerically better tolerated on numerous parameters when compared to standard of care chemotherapy. Regulatory filings are underway.

此外，與標準治療化療相比，IMDELLTRA 顯著改善了患者報告的呼吸困難和咳嗽結果，並且在許多參數上具有更好的耐受性。監理備案正在進行中。

Together with the remarkable DeLLphi-301 data already reported, as Murdo highlighted, IMDELLTRA has the potential to become the new standard of care for second-line small cell lung cancer. We continue to investigate IMDELLTRA in earlier lines of small cell lung cancer. Currently, three additional Phase 3 studies are underway across limited stage and extensive stage disease, along with Phase 1 studies evaluating IMDELLTRA in combination with novel agents to potentially further improve patient outcomes.

正如 Murdo 所強調的，結合已經報告的卓越的 DeLLphi-301 數據，IMDELLTRA 有可能成為二線小細胞肺癌治療的新標準。我們將繼續研究 IMDELLTRA 在早期小細胞肺癌中的作用。目前，針對局限期和廣泛期疾病的另外三項 3 期研究正在進行中，同時還有 1 期研究評估 IMDELLTRA 與新型藥物的聯合使用，以進一步改善患者的治療效果。

We are also focused on enhancing patient convenience by evaluating less frequent dosing and subcutaneous delivery. We continue to investigate our CD19 directed BiTE medicine, BLINCYTO, in earlier treatment settings, while also advancing a subcutaneous formulation. In June, Phase 1b and 2 subcutaneous blinatumomab data were presented and simultaneously published in the Lancet Hematology, demonstrating 89% to 92% remission rates and manageable safety in adults with relapsed/refractory CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

我們也致力於透過評估較低頻率的給藥和皮下給藥來提高患者的便利性。我們將繼續研究針對 CD19 的 BiTE 藥物 BLINCYTO 在早期治療環境中的應用，同時推動皮下製劑的研究。6 月，1b 期和 2 期皮下注射 blinatumomab 的數據在《柳葉刀血液學》上同時公佈，顯示對於復發/難治性 CD19 陽性費城染色體陰性 B 細胞前體急性淋巴細胞白血病的成年人，緩解率為 89% 至 92%，且具有可控的安全性。

Subcutaneous blinatumomab has the potential to improve both the patient experience and efficacy, and we remain on track to initiate a potentially registration-enabling study in both adults and adolescents later this year.

皮下注射 blinatumomab 有可能改善患者的體驗和療效，我們仍計劃在今年稍後針對成人和青少年啟動一項可能具有註冊效力的研究。

Our first-in-class STEAP1 CD3 bispecific T cell engager xaluritamig is advancing in Phase 3 clinical development. We are also exploring xaluritamig in combination therapy and in earlier stages of prostate cancer with multiple Phase 1b studies ongoing. Collectively, IMDELLTRA, BLINCYTO and xaluritamig exemplify the significant growth potential of our robust bispecific T-cell engager platform and reinforce our commitment to bringing groundbreaking treatments to cancer patients worldwide.

我們的首創 STEAP1 CD3 雙特異性 T 細胞接合劑 xaluritamig 正在 3 期臨床開發中取得進展。我們也正在探索 xaluritamig 在合併治療和前列腺癌早期階段的應用，目前正在進行多項 1b 期研究。總的來說，IMDELLTRA、BLINCYTO 和 xaluritamig 體現了我們強大的雙特異性 T 細胞接合平台的巨大成長潛力，並加強了我們為全球癌症患者提供突破性治療的承諾。

Beyond our T cell engagers, in June, we announced data from the Phase 3 FORTITUDE-101 study of first-line bemarituzumab, our first-in-class fibroblast growth factor receptor IIb directed monoclonal antibody. Bemarituzumab plus mFOLFOX6 chemotherapy met its primary endpoint of overall survival at a prespecified interim analysis in patients with unresectable locally advanced or metastatic, FGFR2b positive HER2-negative gastric or gastroesophageal junction cancer.

除了我們的 T 細胞接合劑之外，6 月份，我們還公佈了第一線藥物 bemarituzumab（我們的首創成纖維細胞生長因子受體 IIb 定向單株抗體）的 3 期 FORTITUDE-101 研究數據。對於無法切除的局部晚期或轉移性、FGFR2b 陽性 HER2 陰性胃癌或胃食道連接部癌患者，Bemarituzumab 合併 mFOLFOX6 化療在預定的中期分析中達到了其主要終點，即總存活期。

In closing, I want to extend my gratitude to our colleagues for their dedication to achieving these critical milestones and their unwavering focus on improving outcomes for patients facing serious diseases.

最後，我要向我們的同事們表示感謝，感謝他們為實現這些關鍵里程碑所做的奉獻，以及他們堅定不移地致力於改善面臨嚴重疾病的患者的治療結果。

I'll now turn it over to Peter.

現在我將把發言權交給彼得。

Thank you, Jay. We're pleased with our strong second quarter performance and remain on track with our 2025 full year goals and long-term objectives. The financial results are shown on slides 31 and 32 of the slide deck.

謝謝你，傑伊。我們對第二季的強勁表現感到滿意，並將繼續朝著 2025 年全年目標和長期目標邁進。財務結果顯示在投影片的第 31 張和第 32 張投影片上。

In the second quarter, we delivered revenues of $9.2 billion, reflecting our key growth drivers highlighted on our Q4 earnings call. Repatha, EVENITY, TEZSPIRE in our innovative oncology, rare disease and biosimilar portfolios.

第二季度，我們的營收達到 92 億美元，體現了我們在第四季財報電話會議上強調的關鍵成長動力。我們的創新腫瘤學、罕見疾病和生物相似藥產品組合包括 Repatha、EVENITY、TEZSPIRE。

Our non-GAAP operating expenses rose 8%, led by a non-GAAP R&D growth of 18% year-over-year, reflecting continued investment in our late-stage pipeline, including MariTide, olpasiran, IMDELLTRA, xaluritamig and rare disease.

我們的非公認會計準則營運費用上漲了 8%，其中非公認會計準則研發費用年增 18%，反映了我們對後期研發線的持續投資，包括 MariTide、olpasiran、IMDELLTRA、xaluritamig 和罕見疾病。

Our non-GAAP OI&E was favorable $213 million year-over-year, driven by gains from early retirement of debt and lower interest expense. Recall, we retired $4.5 billion of debt in 2024 and have retired $4.3 billion in the first half of 2025.

我們的非公認會計準則營業收入和支出與去年同期相比增加了 2.13 億美元，這得益於提前償還債務帶來的收益和較低的利息支出。回想一下，我們在 2024 年償還了 45 億美元的債務，並在 2025 年上半年償還了 43 億美元的債務。

Our non-GAAP tax rate decreased 0.7 percentage points year-over-year to 14.2%, primarily due to the change in earnings mix. The company generated $1.9 billion in free cash flow in the second quarter, reflecting operational momentum across the business while continuing to invest in innovation. We invested $1.7 billion in non-GAAP R&D spend, an increase of 18% year-over-year, and expect to build on this momentum in the second half of the year with increased investment in our innovative late-stage pipeline.

我們的非公認會計準則稅率年減 0.7 個百分點至 14.2%，主要歸因於收益結構的變動。該公司第二季產生了 19 億美元的自由現金流，反映了整個業務的營運勢頭，同時繼續對創新進行投資。我們在非公認會計準則研發上投入了 17 億美元，年增 18%，預計下半年我們將在這一勢頭的基礎上增加對創新後期研發管線的投資。

We are accelerating innovation and productivity through AI investments across the value chain, from discovery to development to commercial execution and in G&A. This is enabled by digitized workflows, modernized data infrastructure and global access to advanced generative AI tools.

我們透過對整個價值鏈（從發現到開發到商業執行以及一般及行政管理）的人工智慧投資來加速創新和生產力。這是透過數位化工作流程、現代化資料基礎設施和全球範圍內對先進生成 AI 工具的存取來實現的。

For 2025, we continue to expect capital expenditures of $2.3 billion to expand network capacity for our products across the portfolio and our innovative pipeline, including MariTide. In addition, we returned capital to shareholders through competitive dividend payments of $2.38 per share, representing a 6% increase compared to the second quarter of 2024.

到 2025 年，我們仍預期資本支出為 23 億美元，以擴大我們整個產品組合和創新管道（包括 MariTide）的網路容量。此外，我們還透過每股 2.38 美元的有競爭力的股息支付向股東返還資本，與 2024 年第二季度相比增長了 6%。

Turning to the outlook for the business for 2025 on slide 33. We expect our 2025 total revenues in the range of $35.0 billion to $36.0 billion and non-GAAP earnings per share between $20.20 and $21.30. This guidance includes the estimated impact of implemented tariffs. It does not account for tariffs or pricing actions announced or described but not implemented.

第 33 張投影片介紹了 2025 年的業務前景。我們預計2025年總收入將在350億美元至360億美元之間，非公認會計準則每股收益將介於20.20美元至21.30美元之間。此預期已包含已實施關稅的預估影響。它不考慮已宣布或描述但尚未實施的關稅或定價行動。

In addition, let me highlight a few updates to our outlook for the remainder of the year. We now expect full year non-GAAP operating margin as a percentage of product sales to be roughly 45%. Our outlook now includes several business development transactions, resulting in roughly $200 million of incremental R&D expense expected in Q3.

此外，讓我重點介紹一下我們對今年剩餘時間的展望的一些更新。我們現在預計全年非 GAAP 營業利潤率佔產品銷售額的百分比約為 45%。我們的展望現在包括幾項業務發展交易，預計第三季的增量研發費用約為 2 億美元。

The outlook continues to reflect our investments in advancing key late-stage programs, including MariTide, olpasiran and IMDELLTRA and leveraging technological advancements, including artificial intelligence. Our operating margin outlook also includes incremental launch and commercial investments, starting in the third quarter.

這一前景繼續反映了我們對推進關鍵後期項目的投資，包括 MariTide、olpasiran 和 IMDELLTRA，以及利用包括人工智慧在內的技術進步。我們的營業利潤率展望還包括從第三季開始的增量發布和商業投資。

In line with these priorities and reflecting the business development transactions of roughly $200 million, we now expect non-GAAP R&D expense to grow over 20% in 2025. We now anticipate non-GAAP OI&E to be approximately $2.2 billion in 2025. For WEZLANA and AMJEVITA sales in the United States, we continue to expect quarterly sales to fluctuate and do not expect any sales in the third quarter.

根據這些優先事項，並反映約 2 億美元的業務發展交易，我們現在預計 2025 年非 GAAP 研發費用將增加 20% 以上。我們現在預計 2025 年非 GAAP OI&E 將達到約 22 億美元。對於 WEZLANA 和 AMJEVITA 在美國的銷售情況，我們預計季度銷售額仍將出現波動，並且預計第三季不會有任何銷售額。

And let me remind you of prior items that have not changed. For the full year, we continue to expect other revenue to be approximately $1.4 billion. We expect a non-GAAP tax rate of 14.5% to 16.0%. We expect share repurchases not to exceed $500 million in 2025.

讓我提醒您，之前的事情並沒有改變。就全年而言，我們繼續預計其他收入約為 14 億美元。我們預計非公認會計準則稅率為 14.5% 至 16.0%。我們預計 2025 年股票回購額不會超過 5 億美元。

We are focused on delivering sustained long-term value for patients and shareholders by doing what we said we would do, growing leadership in the United States and internationally, driving innovation in areas of high unmet medical need and maintaining rigorous financial discipline. We continue to focus on execution excellence across the enterprise and remain well positioned for sustained growth through the long term. I'm grateful to work with all of our colleagues worldwide in serving patients.

我們致力於透過履行承諾、在美國和國際上提升領導地位、推動醫療需求高度未滿足領域的創新以及保持嚴格的財務紀律，為患者和股東提供持續的長期價值。我們將繼續關注整個企業的卓越執行，並為長期持續成長做好準備。我很高興能與世界各地的同事一起為患者服務。

This concludes our financial update. I'll now hand it back to Bob for our Q&A session.

我們的財務更新到此結束。現在我將把它交還給鮑勃，進行我們的問答環節。

Julianne, could you now open the call for questions and just remind our callers of the procedure for submitting their question to us. Thanks.

朱麗安，您現在可以開始提問了嗎，並提醒我們的來電者向我們提交問題的程序。謝謝。

(Operator Instructions)

（操作員指示）

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great. Thanks so much. Maybe just the first question on Jay, for you on MariTide. In Q4, when we have the second year data, how much granularity are we going to be able to glean from the patients who are going on maintenance? And are you going to give us data on Q8 weeks and Q12 weeks at that point? Thank you.

偉大的。非常感謝。也許這只是關於 Jay 的第一個問題，關於 MariTide。在第四季度，當我們獲得第二年的數據時，我們能夠從接受維持治療的患者那裡收集到多少詳細資訊？那時您會向我們提供第 8 季和第 12 季的數據嗎？謝謝。

Thank you, Yaron. As you identified and gathered from our words moments ago, the data readout from the Phase 2 type 2 diabetes study and part 2 of the chronic weight management studies are expected in Q4 of 2025, and we'll have more to share about these data in due course.

謝謝你，亞倫。正如您剛才從我們的話中了解到的，第 2 階段 2 型糖尿病研究和第 2 部分慢性體重管理研究的數據預計將於 2025 年第四季度公佈，我們將在適當的時候分享更多有關這些數據的信息。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Good afternoon. Thanks for taking my question. So the industry has been adopting a number of strategies here which you spoke to with regard to helping the administration achieve their goals to reduce drug pricing, but that goalpost is still shifting around you with the latest angle being Medicaid MFN. So curious here as to your thoughts on that cloud specifically, but additionally, how you are thinking about DTC efforts, which seem to be a growing theme across the industry and was called out by one of your peers this morning? Thank you.

午安.感謝您回答我的問題。因此，該行業一直在採取一些策略，您談到了幫助政府實現降低藥品價格的目標，但這個目標仍在不斷變化，最新的角度是醫療補助最惠國政策。所以我很好奇您對雲端的具體看法，此外，您如何看待 DTC 工作，這似乎是整個行業日益增長的主題，並且今天早上您的一位同行也提到了這一點？謝謝。

Well, Salveen, I think it may be a little premature to speak in detail about any one of the particular proposals. But what I would say at a higher altitude is that we agree that reform is needed in the US health care system. And we would like for our medicines and all the medicines in this country to be more affordable and for those medicines to be more widely available.

好吧，薩爾文，我認為現在詳細談論任何一項具體提議可能還為時過早。但從更高層次來說，我想說的是，我們都同意美國醫療保健系統需要改革。我們希望我們的藥品以及這個國家的所有藥品都更加便宜，並且這些藥品能夠更廣泛地普及。

So at Amgen, obviously, we also believe that this country and the world needs more innovation, not less. And so the onus is on us to help find ways to reform, to bring the price of medicines down, to make them more widely accessible while preserving the innovative ecosystem that has enabled this country to be the world leader in biopharmaceutical medicines.

因此，在安進，我們顯然也相信這個國家和世界需要更多的創新，而不是更少。因此，我們有責任幫助尋找改革的方法，降低藥品價格，使人們更容易獲得藥品，同時保護使這個國家成為世界生物製藥領導者的創新生態系統。

So we welcome the government's focus on the role that foreign countries can play in trying to preserve that innovative ecosystem by rewarding innovation fairly. And we expect to work with this administration to try and find a path forward that helps to achieve their objectives and I think the objectives of many leaders in this industry.

因此，我們歡迎政府重視外國在透過公平獎勵創新來保護創新生態系統方面所能發揮的作用。我們希望與本屆政府合作，努力找到一條有助於實現其目標的道路，我認為這也是該行業許多領導者的目標。

So still a little bit early days, Salveen, to talk in any detail about specific initiatives or specific proposals. But we've enjoyed a good working relationship with the administration, and we expect that we'll continue to have the opportunity to work with them to advance on this front.

因此，薩爾文，現在就詳細討論具體舉措或具體建議還為時過早。但我們與政府保持良好的工作關係，我們希望繼續有機會與他們合作，共同推動這一領域的工作。

Thanks. Alright, Julianne, let's take the next question, please.

謝謝。好的，茱麗安，請我們回答下一個問題。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Thanks. So you cited strong performance, in particular, from the rare disease business and you're getting back to a capital structure that looks more like it was prior to the Horizon transaction. So I guess my question here is, what is your appetite for significant consequential M&A regarding rare diseases? And what is your appetite in general for continuing to build out that broad therapeutic vertical? Thank you.

謝謝。因此，您提到了強勁的表現，特別是罕見疾病業務的表現，並且您正在恢復看起來更像 Horizo​​n 交易之前的資本結構。所以我想我的問題是，您對罕見疾病領域的重大併購有何興趣？您對繼續拓展廣泛的垂直治療領域有何整體興趣？謝謝。

David, your question seems to focus on the word “significant.” And I don't know what your definition of significant is. But what I would say, I would reiterate that we remain very interested in rare disease. We think the portfolio of rare disease assets that we have both in the market now and the pipeline of rare assets is very attractive. We will continue to look for ways to grow our rare disease business both organically and to the extent that they are licensing or acquisition opportunities, we'll look for those as well.

大衛，你的問題似乎集中在「重要」這個詞上。我不知道你對「重要」的定義是什麼。但我想重申的是，我們仍然對罕見疾病非常感興趣。我們認為，我們目前在市場上擁有的罕見疾病資產組合和稀有資產管道非常有吸引力。我們將繼續尋找方法來有機地發展我們的罕見疾病業務，並且只要有許可或收購機會，我們也會尋找。

I would point out on the question of transactions, whether it's in rare disease or elsewhere, that we've a lot of activity right now, in particular, in our portfolio, a lot of late-stage activity. And so we'll be very mindful about wanting to continue to execute flawlessly across those programs. So -- but again, thanks for observing that the capital structure has followed the course that we told you to expect, and we feel very good about the progress we've made in integrating Horizon and shoring up the balance sheet.

我想指出的是，關於交易問題，無論是在罕見疾病領域還是其他領域，我們現在都有很多活動，特別是在我們的投資組合中，有很多後期活動。因此，我們會非常注意繼續完美地執行這些計劃。所以——但再次感謝您觀察到資本結構遵循了我們告訴您的預期路線，我們對整合 Horizo​​n 和鞏固資產負債表所取得的進展感到非常滿意。

Hi, Julian take the next question, please.

你好，請朱利安回答下一個問題。

Courtney Breen, Bernstein.

考特尼·布林，伯恩斯坦。

Hi, Amgen team. Thanks for taking my question today. The first one is just on MariTide. As we look at the three-step dose escalation that you've incorporated into the Phase 3s that have been announced, this incorporates kind of a physician if we think about the future clinical use, having to select the maintenance dose kind of straight after the last titration dose rather than stepping through each of the potential maintenance doses, which is what we see in practice in the market today.

嗨，安進團隊。感謝您今天回答我的問題。第一個就在 MariTide 上。當我們看到你們在已宣布的 3 期臨床試驗中採用的三步劑量遞增法時，如果我們考慮未來的臨床使用，這就要求醫生必須在最後一次滴定劑量之後直接選擇維持劑量，而不是逐步選擇每個潛在的維持劑量，而這正是我們目前在市場上看到的。

Can you explain kind of why you think this is a better paradigm to be using? Or how you expect kind of physicians to select right dose for the patient that they have in front of them given they will have only had the titration information or feedback for that particular patient up until that point?

您能否解釋為什麼您認為這是一個更好的範例？或者，考慮到醫生到目前為止只掌握了針對特定患者的滴定資訊或回饋，您如何期望醫生為他們面前的患者選擇正確的劑量？

Thank you very much, Courtney. Why don't I try and answer here. As a monoclonal antibody, dose escalation with MariTide is naturally very smooth, very steady, as we've shared. And as we firmly believe, progressive benefit can be derived from a tolerability standpoint with both lower doses and also with multiple steps to target.

非常感謝，考特尼。我為什麼不嘗試在這裡回答呢？正如我們所分享的，作為單株抗體，MariTide 的劑量增加自然非常平穩、非常穩定。我們堅信，從耐受性的角度來看，透過降低劑量並採取多個步驟可以帶來漸進的益處。

This is very consistent with the experience of the field and the 21-milligram starting dose selected for Phase 3 clinical investigation indeed has a very low risk of serious GI events and progressing to a highly efficacious target dose.

這與該領域的經驗非常一致，並且為 3 期臨床研究選擇的 21 毫克起始劑量確實具有非常低的嚴重胃腸道事件風險，並且可以進展到高效的目標劑量。

And indeed, we're studying several in the Phase 3 study. We'll deliver both the well-tolerated patient experience and give us a graded understanding of dose and response. And so the Phase 3 design was very carefully conceived in order to read out dose proportionate benefit to MariTide. You also asked about maintenance, and I appreciate you bringing this up. It's just true that these are chronic diseases that run with obesity as is obesity and overweight themselves.

事實上，我們正在進行第三階段的研究。我們將提供耐受性良好的患者體驗，並讓我們對劑量和反應有分級的了解。因此，我們非常仔細地構思了第 3 階段的設計，以便讀出與 MariTide 劑量成比例的益處。您也詢問了維護問題，感謝您提出這個問題。確實，這些都是與肥胖伴隨的慢性疾病，就像肥胖和超重本身一樣。

And long-term treatment of these diseases has proven just very challenging with these weekly injectable peptides with very low persistence on medicine. And our studies together will guide the optimal use of MariTide for long-term maintenance therapy, where patients and doctors will no doubt work together to sustain the benefits of MariTide on doses and perhaps even different schedules guided by these data.

事實證明，透過每週注射一次且藥物持久性很低的勝肽來長期治療這些疾病非常具有挑戰性。我們的共同研究將指導 MariTide 在長期維持治療中的最佳使用，患者和醫生無疑將共同努力，根據這些數據指導的劑量甚至不同的時間表來維持 MariTide 的益處。

Hi, Julianne, next question, please

嗨，朱莉安，請問下一個問題

Umer Raffat, Evercore ISI.

Umer Raffat，Evercore ISI。

Hi guys, thanks for taking my question. On VESALIUS CVOT or PCSK9 outcomes trial, I'm curious how you're thinking about the event rate accumulation over time? It looks like by the time it reads out by year-end this year, it's basically right around that 4.5 year follow-up, which you were anticipating. I guess my confusion is, is that time line driven by the 4.5-year follow-up? Or is it rather because you're hitting those predefined events of 750 plus on the triple and 1250 on the quadruple? Thank you very much.

大家好，感謝你們回答我的問題。關於 VESALIUS CVOT 或 PCSK9 結果試驗，我很好奇您如何看待事件發生率隨時間推移的累積？看起來，到今年年底的時候，它基本上就在你所預期的 4.5 年的後續時間左右。我想我的困惑是，這個時間線是由 4.5 年的後續行動所驅動的嗎？還是因為你達到了三重 750 以上和四重 1250 的預定事件？非常感謝。

Thanks, Umer, for your question. As you surely know, and based -- your -- sophisticated question, VESALIUS CV, for everyone, is our primary prevention study of PCSK9 inhibition in cardiovascular risk reduction. We anticipate a readout in the second half of this year. The readout is purely based on accumulated events or event rate.

謝謝 Umer 的提問。如您所知，基於您提出的複雜問題，VESALIUS CV 對每個人來說都是我們對 PCSK9 抑制在降低心血管風險方面的主要預防研究。我們預計今年下半年將會有結果。讀數純粹基於累積事件或事件率。

Julianne, next question, please.

朱麗安，請問下一個問題。

Terrence Flynn, Morgan Stanley.

摩根士丹利的特倫斯弗林。

Great, thanks so much for taking the question. Maybe another one for Jay. I was just wondering if you could provide any more thoughts on how you're thinking about the design of MariTide CVOT study in type 2 diabetes in light of Eli Lilly's recent SURPASS-CVOT data where they compared tirzepatide to Trulicity and just how you -- how that might influence how you're thinking about control arm for your study? Thank you.

太好了，非常感謝您回答這個問題。或許是給傑伊的另一個。我只是想知道，您是否可以根據禮來公司最近的 SURPASS-CVOT 數據（他們將 tirzepatide 與 Trulicity 進行了比較）提供更多關於您對 2 型糖尿病 MariTide CVOT 研究設計的看法，以及這可能會如何影響您對研究對照組的看法？謝謝。

Yes. Thanks very much for the question. We read the paper with real interest and as you can imagine, follow the field quite closely. We indeed have four MariTide Phase 3 studies underway. They're all enrolling well. The CVOT presently opened is with atherosclerotic coronary vascular disease with obesity and overweight, and we'll have more to share around our plan for pivotal studies in diabetes and in their cardiovascular outcomes in the fullness of time.

是的。非常感謝您的提問。我們懷著濃厚的興趣閱讀了這篇論文，正如您所想的那樣，我們非常密切地關注著這個領域。我們確實有四項 MariTide 第三階段研究正在進行中。他們全都入學順利。目前開展的 CVOT 是針對肥胖和超重引起的動脈粥狀硬化性冠狀血管疾病，隨著時間的推移，我們將分享更多關於糖尿病及其心血管結果的關鍵研究計劃。

Okay, Julianne, take the next question, please.

好的，茱麗安，請回答下一個問題。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Oh hey, Congrats on the quarter. And it was nice to see the positive FORTITUDE-101 top line results for bema. Can you provide some color on the timeline to file for approval, especially with regards to the results for -- from FORTITUDE-102? Do you need those for filing? And also, any color you can give us on when we should expect to see the detailed results from FORTITUDE-101? Thank you.

哦嘿，恭喜本季。很高興看到 FORTITUDE-101 為 bema 帶來了積極的頂線結果。您能否提供一些申請批准的時間表，特別是關於 FORTITUDE-102 的結果？您需要這些來歸檔嗎？另外，您能告訴我們何時可以看到 FORTITUDE-101 的詳細結果嗎？謝謝。

Thanks, Jay. We're very excited about the emerging picture around bemarituzumab. The doublet with chemotherapy was indeed positive for overall survival, which quite matters for all cancers, especially this one, the fifth most common with very little impact to date with targeted therapy. And targeting FGFR2b expression in this cancer, combined with mFOLFOX6 chemotherapy, is a meaningful advance for these patients. We've not yet disclosed our regulatory strategy.

謝謝，傑伊。我們對 bemarituzumab 的新情況感到非常興奮。聯合化療確實對整體存活率有積極作用，這對於所有癌症都至關重要，尤其是這種癌症，它是第五大常見癌症，迄今為止標靶治療的效果非常有限。針對該癌症的 FGFR2b 表達，結合 mFOLFOX6 化療，對這些患者來說是一個有意義的進展。我們尚未披露我們的監管策略。

And as you point out, triplet study that importantly adds checkpoint therapy to this pairing of bemarituzumab and chemotherapy will read out in the second half of this year or the first half of next year. We've adjusted the date range based on our current best estimate, and our regulatory strategy integrates these data sets.

正如您所指出的，重要的是，在貝馬利珠單抗和化療的組合中添加檢查點療法的三聯療法研究將在今年下半年或明年上半年公佈結果。我們根據目前的最佳估計調整了日期範圍，並且我們的監管策略整合了這些資料集。

Hey Julianne, let's take the next question, please.

嘿，朱利安，請我們回答下一個問題。

Chris Schott, JPMorgan.

摩根大通的克里斯·肖特。

Great, thanks so much. Just wanted to come back to Repatha. Just as we're thinking about that primary prevention study, can you just talk a little bit about the bar that you see here in terms of what we see from that data to be clinically meaningful? And once you have that data on level -- on label, like how big of a driver do you see this for that franchise as a whole? Thanks so much.

太好了，非常感謝。只是想回到 Repatha。就像我們正在考慮那項初級預防研究一樣，您能否就我們從該數據中看到的具有臨床意義的標準稍微談談您在這裡看到的標準？一旦你獲得了該級別的數據——標籤上的數據，你認為這對整個特許經營權有多大的推動作用？非常感謝。

Let me take this in two parts, Chris. Maybe Jay, you can kick off and then Murdo, why don't you add your thoughts?

克里斯，讓我把這個問題分成兩個部分來討論。也許傑伊，你可以開始，然後默多，為什麼不添加你的想法呢？

Thanks for the question. There's no level of LDL-C that confers a better outcome for patients with coronary vascular disease. And so really suppressing LDL-C with Repatha in these high-risk patients who've not had yet had an MI or revascularization is in a -- we think a great opportunity for benefit. I'd be loathe to peg a specific overall risk reduction here today. But the field is quite calibrated to what a meaningful outcome would look like for these patients as we've studied this medicine exhaustively in the secondary prevention realm. Murdo?

謝謝你的提問。沒有任何 LDL-C 水平能夠為冠狀血管疾病患者帶來更好的治療效果。因此，我們認為，對於這些尚未發生心肌梗塞或血管重建的高風險患者，使用 Repatha 真正抑制 LDL-C 是一個很大的獲益機會。我今天不太願意在這裡確定具體的整體風險降低幅度。但是，由於我們在二級預防領域對這種藥物進行了詳盡的研究，因此該領域對這些患者的有意義的結果已經進行了相當精確的校準。默多？

Yeah. Thanks for the question, Chris. And I would just say that we're already doing very well in the primary prevention population of patients. Roughly 40% of our Repatha new-to-brand prescriptions are from patients who have yet to suffer a first vascular event. And so we're getting a lot of these high-risk patients right now.

是的。謝謝你的提問，克里斯。我想說的是，我們在患者一級預防人群方面已經做得非常好了。我們約 40% 的 Repatha 新品牌處方來自尚未發生過首次血管事件的患者。因此，我們現在接收了許多這樣的高危險群患者。

What I think a VESALIUS positive result could do is help reinforce the need for more aggressive LDL cholesterol lowering guidelines, help reinforce the need to remove payer barriers, which we have done successfully over time, but still some prior authorization criteria exist for some populations of patients.

我認為 VESALIUS 陽性結果可以幫助強調制定更積極的 LDL 膽固醇降低指南的必要性，幫助強調消除付款人障礙的必要性，我們長期以來已經成功做到了這一點，但對於某些患者群體仍然存在一些事先授權標準。

And of course, we are very interested in continuing to expand the penetration of PCSK9, both in secondary prevention and in primary prevention. So I think this is -- it's an important trial, but it continues to drive the tailwind that we're already experiencing that we've been able to create for Repatha growth in the market.

當然，我們非常有興趣繼續擴大 PCSK9 在二級預防和一級預防中的滲透率。所以我認為這是一個重要的試驗，但它將繼續推動我們已經經歷的順風，為 Repatha 在市場上的成長創造順風。

Alright, Julianne, let's go to the next question, please.

好的，朱麗安，請我們進入下一個問題。

Matthew Phipps, William Blair.

馬修菲普斯、威廉布萊爾。

Thanks for taking my question. Noticed AMG 732 listed on the press release today. Just curious how that program differentiates from TEPEZZA and maybe what unmet need you're looking to address in thyroid eye disease? Thank you.

感謝您回答我的問題。今天在新聞稿中註意到了 AMG 732。只是好奇該計劃與 TEPEZZA 有何不同，以及您希望解決甲狀腺眼疾方面哪些未滿足的需求？謝謝。

Thanks, Matt.

謝謝，馬特。

Yeah. No, thanks for noticing. We're delighted to share in these earnings materials for the first time, the development of AMG 732, which is a next-generation IGF-1R targeting monoclonal antibody. This medicine's benefits from the target validation strongly provided by TEPEZZA and will be presented to patients in a subcutaneous administration. The Phase 2 study is enrolling patients with moderate to severe and active TED and progressing very well. Thank you.

是的。不，謝謝你注意到。我們很高興首次在這些收益材料中分享AMG 732的開發，它是下一代IGF-1R靶向單株抗體。該藥物受益於 TEPEZZA 強力提供的目標驗證，並將透過皮下給藥的方式呈現給患者。階段 2 研究正在招募中度至重度活動性 TED 患者，進展非常順利。謝謝。

I think the big picture here, Matt, is at that the time we acquired Horizon, we said we felt there would be lots of opportunities given the large molecule nature of the portfolio, lots of opportunities for us to introduce innovation over time. And this would be an example of that.

馬特，我認為，這裡的大局是，當我們收購 Horizo​​n 時，我們說，考慮到產品組合的大分子性質，我們認為會有很多機會，隨著時間的推移，我們將有很多機會引入創新。這就是一個例子。

Dave Risinger, Leerink Partners

Leerink Partners 的 Dave Risinger

Yes, thanks very much and congrats, Bob team on some great financial momentum. So I'm curious about the end of the press release highlighting the development of biosimilar versions of OPDIVO, KEYTRUDA and OCREVUS. I know that, that's not new news, but can you please discuss how you see the potential for IV biosimilars to compete with high hyaluronidase subcutaneous versions which are set to experience significant uptake ahead of the opportunity to launch IV biosimilars? Thanks so much.

是的，非常感謝，並祝賀鮑勃團隊取得了巨大的財務發展勢頭。因此，我對強調 OPDIVO、KEYTRUDA 和 OCREVUS 生物相似藥開發的新聞稿結尾感到好奇。我知道，這並不是什麼新鮮事，但您能否討論一下您如何看待靜脈注射生物相似藥與高透明質酸酶皮下注射劑競爭的潛力？在推出靜脈注射生物相似藥之前，高透明質酸酶皮下注射劑將獲得顯著的吸收？非常感謝。

Yeah. Murdo, do you want to take the first stab there and then invoke Jay however you like.

是的。默多，你想先下手為強，然後再隨心所欲地召喚傑伊嗎？

Sure. Dave, thanks for the question. Obviously, we're excited about the growth that we're seeing in our biosimilar portfolio overall. And Amgen's success here has been remarkable, quite frankly since 2018, now cumulative $12 billion of revenue generated by this portfolio of products. We've had a 100% success rate in regulatory, both development and regulatory milestones. And of course, we continue to grow the business year-over-year this year with 40% growth with the most recent launches of PAVBLU, BKEMV this year.

當然。戴夫，謝謝你的提問。顯然，我們對生物相似藥產品組合整體的成長感到非常興奮。坦白說，安進在這方面的成功令人矚目，自 2018 年以來，該產品組合累計創造了 120 億美元的收入。我們在監管方面的成功率達到了 100%，包括開發和監管里程碑。當然，隨著今年最新的 PAVBLU 和 BKEMV，我們的業務繼續年增 40%。

So we're very pleased with the use of capital invested in this. We know the oncology space very well. We were one of the first companies to launch oncology biosimilars. So we feel that we understand the dynamics for KEYTRUDA and OPDIVO. We're watching the hyaluronidase uptake very closely and to see if subcu has a role to play in the treatment of cancers.

因此，我們對這方面的投資資金使用感到非常滿意。我們非常了解腫瘤學領域。我們是第一批推出腫瘤生物相似藥的公司之一。因此，我們覺得我們了解 KEYTRUDA 和 OPDIVO 的動態。我們正在密切關注透明質酸酶的吸收，看看皮下注射是否在癌症治療中發揮作用。

I think what we're particularly interested in seeing is whether or not the cadence of the PD-1 dosing lines up with the chemotherapy dosing or other adjuvant therapy and combination therapy. But we're watching it closely. And if Amgen decided to further develop other biosimilars, we would and could. Jay?

我認為我們特別感興趣的是 PD-1 劑量的節奏是否與化療劑量或其他輔助療法和聯合療法一致。但我們正在密切關注。如果安進決定進一步開發其他生物相似藥，我們就會這麼做，而且也可以這麼做。傑伊？

Yeah, I would just only add really medically, as an oncologist, use of these breakthrough immuno-oncology checkpoint medicines is pretty firmly mapped into treatment plans, treatment practices, patterns of practice really all across the world and bringing forward these two medicines, ABP 206 and ABP 234, is just really a seamless move to bring biosimilar medicines into an area of oncology that has benefited from innovation, and now we'll benefit even better from access.

是的，我只想補充一點，從醫學角度來看，作為一名腫瘤學家，這些突破性的免疫腫瘤檢查點藥物的使用已經非常牢固地融入到世界各地的治療計劃、治療實踐和實踐模式中，而推出這兩種藥物 ABP 206 和 ABP 234，實際上是將生物仿製藥引入受益於創新的腫瘤學領域的一個無縫訪問，現在我們將從更多的藥物舉措中受益於創新的腫瘤學舉措，現在我們將從更多獲取藥物舉措中受益於創新的腫瘤學舉措，現在我們將從更多獲取藥物的舉措中受益於創新的腫瘤學舉措，現在我們將從更多的藥物舉措中受益於創新。

Hey Julianne, take the next question, please.

嘿，朱利安，請回答下一個問題。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

Hi guys, thank you so much for taking my question. I actually wanted to touch on IMDELLTRA. You noted impressive growth this quarter, and I'm really trying to understand kind of what's driving the volume. Is it increased penetration into that refractory population? And how do you see this panning out over the course of the year? I'm just trying to get a sense as to where this could go. Thank you very much.

大家好，非常感謝你們回答我的問題。我實際上想談談 IMDELLTRA。您注意到本季度取得了令人印象深刻的成長，我真的想了解推動這一成長的因素是什麼。它是否增加了對難治性族群的滲透？您認為今年的進展會如何？我只是想知道這會發生什麼。非常感謝。

Yeah. Thanks, Evan. The growth in IMDELLTRA is definitely an uptake on those patients, those small cell lung cancer patients who are progressing on or after chemotherapy. So we're seeing utilization consistent with the data that we've generated so far. I think the data that we presented in June at ASCO were obviously compelling first time real overall survival benefit has been shown in that particular setting of small cell lung cancer.

是的。謝謝，埃文。IMDELLTRA 的成長無疑對那些在化療期間或化療後病情進展的小細胞肺癌患者俱有積極作用。因此，我們看到的利用率與我們迄今為止產生的數據一致。我認為我們六月在 ASCO 上展示的數據顯然令人信服，首次證明了在小細胞肺癌這種特定情況下真正的整體生存獲益。

We're also seeing an improvement in both academic and community setting ability to operationalize the monitoring required for IMDELLTRA. And I think that probably had a slightly dampening effect at the beginning of the launch and is now more or less being managed as appropriate.

我們也看到學術界和社區在實施 IMDELLTRA 所需監控的能力方面都有所提高。我認為這可能在發布之初產生了輕微的抑製作用，現在或多或少得到了適當的管理。

So we're seeing good volume growth, very strong clinical conviction. As I said, it's the first time we've seen such compelling data in this setting in small cell lung cancer. And I'm looking forward to more data as it progresses, and we'll have more to say about how we see the growth of this really important asset as we see more data.

因此，我們看到了良好的銷售成長和非常強勁的臨床信心。正如我所說，這是我們第一次在小細胞肺癌中看到如此令人信服的數據。我期待著隨著研究的進展獲得更多數據，隨著我們看到更多數據，我們將對如何看待這項真正重要資產的成長有更多了解。

The only thing I might add there, Evan, is that the strength of the launch and the breadth of uptake that we've seen, in particular from the clinics encourages us for the future of the BiTE portfolio. And as you know, we're excited about xaluritamig. So the lessons we're learning here, no doubt will be useful in that context. But all signs so far are really positive.

埃文，我唯一想補充的是，這次發布的力度和我們所看到的廣泛接受度，特別是來自診所的接受度，鼓舞了我們對 BiTE 產品組合的未來。如您所知，我們對 xaluritamig 感到非常興奮。因此，我們在這裡學到的教訓無疑在這種情況下是有用的。但迄今為止的所有跡像都是積極的。

Hey Julianne, let's go to next question, please.

嘿，朱麗安，請我們進入下一個問題。

Alex Hammond, Wolfe Research.

沃爾夫研究公司的亞歷克斯·哈蒙德。

Thanks for taking the question. So another on the biosimilar front. So we've seen this regulatory landscape evolving. So I guess looking forward, what changes could we see from regulatory standards to establish comparability? Could we see PK comparability versus randomized Phase 3 trials to be feasible? And how could these dynamics possibly modulate your long-term guidance of greater than $4 billion in sales by 2030?

感謝您回答這個問題。生物相似藥方面還有另一個問題。我們看到監管格局正在不斷演變。所以我想展望未來，我們可以看到監管標準發生哪些變化以建立可比性？我們能否看到 PK 可比性與隨機 3 期試驗的可行性？這些動態因素可能如何影響您在 2030 年實現銷售額超過 40 億美元的長期目標？

We'll take this in two parts. Jay, there's some clinical regulatory questions, and Murdo, perspective on the market.

我們將分成兩部分來討論這個問題。Jay，有一些臨床監管問題，還有Murdo，關於市場的看法。

Yeah. Thanks, Alex. We too have been very interested to see some possible -- I mean, not as yet firm pathways, the possible softening of some of the regulatory requirements for biosimilar medicines. And this really plays very favorably to our differentiated capacity to develop very high-quality compositions that map to the established innovator medicine.

是的。謝謝，亞歷克斯。我們也非常有興趣看到一些可能的東西——我的意思是，目前還不明確的途徑，一些生物相似藥的監管要求可能會放寬。這確實對我們開發與成熟的創新藥物相匹配的高品質藥物組合的差異化能力非常有利。

Now this may or may not be true in all geographies around the world, and so we have to consider this a global regulatory go-to-market plan. But from a drug development standpoint and an innovation of biosimilar standpoint, these changes, we believe, accentuate our comparative and differentiated capacity of biosimilars. Murdo?

現在，這可能在世界各地都是正確的，也可能不是，所以我們必須將其視為全球監管的上市計劃。但從藥物開發的角度和生物相似藥創新的角度來看，我們認為這些變化突顯了我們生物相似藥的比較和差異化能力。默多？

Yeah. Thanks, Jay. The only thing I would add is this is still a technically difficult area and requires significant expertise in designing molecules that will meet the parameters, even in the new parameters that the FDA are requiring for comparability of a biosimilar to an originator.

是的。謝謝，傑伊。我唯一想補充的是，這仍然是一個技術難題，需要大量的專業知識來設計符合參數的分子，甚至需要符合 FDA 對生物相似藥與原廠藥可比性的新參數的要求。

There might be less clinical trial effort required for data generation, but it's still technically difficult to do what we do. And we're fortunate we have a very strong process development organization here at Amgen, who are often very adept at finding unique ways to develop biosimilars that do not infringe on the intellectual property of others.

資料產生所需的臨床試驗工作量可能較少，但從技術上講，我們所做的事情仍然很困難。我們很幸運，安進有非常強大的製程開發組織，他們通常非常善於尋找獨特的方法來開發不侵犯他人智慧財產權的生物相似藥。

Alex, just -- topic of biosimilars and the adoption of them in the US is often a subject in policy and other circles in Washington, DC. And I think from our perspective, the market is developing well. There's an appropriate regulatory framework and the assurance of safe, reliable supply is important here. But again, I think this is a market that's developing well and pretty much playing out as we expected it would when we committed capital to development products in the area.

亞歷克斯，生物相似藥及其在美國的應用，一直是華盛頓特區政策和其他領域經常討論的話題。我認為從我們的角度來看，市場發展得很好。這裡有一個適當的監管框架，確保安全、可靠的供應非常重要。但我再次認為，這個市場發展良好，並且基本上符合我們在該地區投資開發產品時所預期的結果。

Okay, Julianne, go to the next question, please.

好的，朱麗安，請進入下一個問題。

Mohit Bansal, Wells Fargo.

富國銀行的 Mohit Bansal。

Hi, This is Sadi Rahman on for Mohit. Can you talk about the -- your confidence in the TEZSPIRE COPD program and in light of a competitor's Phase 3 trial missing despite good Phase 2 data from their molecule in COPD? And how are you thinking about the patient profile that's most likely to benefit from TEZSPIRE, particularly around eosinophil levels? Thanks.

大家好，我是 Sadi Rahman，代表 Mohit 報道。您能否談談您對 TEZSPIRE COPD 計劃的信心，以及考慮到競爭對手的 3 期試驗缺失，儘管他們的分子在 COPD 方面的 2 期試驗數據良好？您如何看待最有可能從 TEZSPIRE 中受益的患者特徵，尤其是嗜酸性粒細胞水平？謝謝。

Yeah. Thank you for the question. I mean the short answer is we feel great about the mechanism and confidence in it for COPD. And the profile, especially with an understanding of the responder population as likely relating to the degree of (inaudible) immunity's contribution as measured by the biomarker of blood eosinophil count as a possible biomarker of response, we feel very strong.

是的。謝謝你的提問。我的意思是，簡短的回答是，我們對這種治療 COPD 的機制感到非常滿意，並且對其充滿信心。並且，特別是透過了解響應者群體可能與（聽不清楚）免疫貢獻程度有關的情況（以血液嗜酸性粒細胞計數的生物標誌物作為可能的響應生物標誌物來衡量），我們感覺非常強勁。

I assume here that you're speaking to the recent Roche data. And this is a molecule we know well, actually comes from Amgen, astegolimab. And though that Phase 2 data did not repeat in Phase 3, I would just remark that the ST2 pathway is distinct from the TSLP pathway. And so I wouldn't be quick, not that you're doing this to lump the two.

我假設您正在談論最近的羅氏數據。這是我們熟悉的一種分子，實際上來自安進公司，名為 Astegolimab。儘管第 2 階段的數據沒有在第 3 階段重複，但我只想說 ST2 通路與 TSLP 通路不同。所以我不會很快下結論，你這樣做並不是要將兩者混為一談。

The ST2 pathway, this suppressor of tumorigenicity 2 protein, is quite distinct from the more allergic or eosinophil-driven TSLP pathway. ST2 is a nonallergic signaling pathway that relates more to epithelial damage. And so while disappointed for patients that the Phase 3 in all-comers didn't read through with that molecule, we feel very confident in the test fire mechanism of action, the Phase 2 data and are conducting these experiments now together with our partners at AZ to get an answer.

ST2 路徑（致瘤性 2 蛋白的抑制劑）與過敏性較強或嗜酸性粒細胞驅動的 TSLP 路徑截然不同。ST2 是一種非過敏性訊號通路，與上皮損傷更相關。因此，儘管我們對所有受試者的 3 期臨床試驗未能通過該分子試驗感到失望，但我們對試驗的作用機制和 2 期試驗數據非常有信心，並且現在正與 AZ 的合作夥伴一起進行這些實驗以找到答案。

Hey, Julianne, let's take the next question, please.

嘿，朱麗安，請我們回答下一個問題。

Luca Issi, RBC Capital.

伊西（Luca Issi），加拿大皇家銀行資本管理公司（RBC Capital）。

Oh great, thanks so much for taking my question. Great. Maybe if I can circle back on obesity. You obviously have two molecules in development here with MariTide and AMG 513. However I believe both molecules are injectables versus Eli Lilly (inaudible) some very encouraging data or Orforglipron at ADA, which is obviously an oral small molecule. What's Amgen's appetite to augment your current offering in Obesity by adding an oral small molecule via either BD or organic discovery?

哦，太好了，非常感謝您回答我的問題。偉大的。也許我可以重新討論肥胖問題。顯然，你們正在開發兩種分子，即 MariTide 和 AMG 513。然而，我相信這兩種分子都是注射劑，而禮來公司（聽不清楚）有一些非常令人鼓舞的數據，或者 ADA 的 Orforglipron 顯然是一種口服小分子。安進公司是否有興趣透過 BD 或有機發現增加口服小分子來增強您目前在肥胖症領域的產品？

I guess the other way to ask that question is, what percentage of the obesity market do you think could ultimately be oral versus injectable? Any color there, much appreciated. Thanks so much.

我想，換一種問法來問這個問題：您認為最終在肥胖症市場中，口服藥物和注射藥物的比例分別是多少？無論什麼顏色，都非常感激。非常感謝。

Yeah. Maybe we can add some color from a few different perspectives here, Luca. So first, I would say on BD, obviously, we're open. We're paying very close attention to all interesting innovation in the field of obesity and related conditions. So we have and we'll continue to look carefully at things that might be helpful to patients that are managing these diseases.

是的。也許我們可以從幾個不同的角度來添加一些色彩，盧卡。首先，我想說，對於 BD，顯然我們是開放的。我們密切關注肥胖和相關疾病領域的所有有趣的創新。因此，我們已經並將繼續仔細研究可能對治療這些疾病的患者有幫助的事物。

Jay, maybe you want to offer some thoughts on the clinical aspects, and then Murdo, why don't you talk about the market dynamic?

傑伊，也許你想就臨床方面提出一些想法，然後默多，你為什麼不談談市場動態呢？

Well, you're right. There remains a massive unmet need, maybe 2% of patients with obesity are currently addressed by current medicines, which are quite hard to take for even longer than a calendar year and, of course, aren't cured by these medicines. And so there's a big opportunity for distinctive medicines, new mechanisms, differentiated properties and potentially different routes of administration as well.

嗯，你說得對。仍有大量未滿足的需求，目前約有 2% 的肥胖症患者依靠現有藥物治療，但這些藥物很難持續服用超過一年，當然也無法治癒。因此，獨特的藥物、新機制、差異化特性以及潛在的不同給藥途徑也有很大的發展機會。

Just exactly as Bob said, we didn't just wander in obesity because it became hot. We've been studying these pathways for more than a decade. Our research and development pipeline earlier than the two medicines you cited targets incretin pathway, also non-incretin pathway medicines rising up in our pipeline. Some of these medicines may indeed be given orally. And so please more to follow from Amgen Research.

正如鮑伯所說，我們不會因為天氣變熱就陷入肥胖。我們已經研究這些途徑十多年了。在您提到的兩種藥物之前，我們的研發管道就以腸促胰島素途徑為目標，同時我們的管道中也正在出現非腸促胰島素途徑藥物。其中一些藥物確實可以口服。請繼續關注安進研究公司的更多動態。

Murdo, would you want to comment about the market? And how it's shaping up for orals and for MariTide.

Murdo，你想評論市場嗎？以及它對口腔和 MariTide 的影響如何。

Yes. Luca, thanks for the interest, and that's obviously an important question as we try to project the market going forward. As Bob said, we are interested in looking at orals, and that comes from us seeing orals constituting a decent portion of the market.

是的。盧卡，感謝您的關注，這顯然是一個重要的問題，因為我們試圖預測未來的市場。正如鮑伯所說，我們對口香糖很感興趣，這是因為我們看到口香糖佔據了相當大的市場。

But I think our flagship product, MariTide, is clear in its differentiation, and that is to treat people for their chronic weight management so that they can benefit in a cardiometabolic way for their health so they have less ultimately, cardiovascular comorbidity or mortality. And so that's what we're doing. We're taking MariTide into the clinic for full breadth of indications.

但我認為我們的旗艦產品 MariTide 的差異化很明顯，那就是為人們提供慢性體重管理治療，使他們能夠以心臟代謝的方式受益，從而最終減少心血管合併症或死亡率。這就是我們正在做的事情。我們將 MariTide 引入臨床，以全面探索其適應症。

And as Jay also mentioned, we believe we have a differentiated product that makes it much easier for patients to persist with their chronic weight management treatment over the course of their lifespan so that they can benefit from that in important ways with outcomes. So looking at the orals very closely, but excited about our flagship product that we're developing.

正如傑伊所提到的，我們相信我們擁有一款差異化的產品，可以讓患者在其一生中更容易堅持慢性體重管理治療，以重要的方式從中受益。因此，我們非常仔細地觀察口腔，但對我們正在開發的旗艦產品感到興奮。

All right, Julianne, let's go to the next question, please.

好的，朱麗安，請我們進入下一個問題。

Geoff Meacham, Citibank.

花旗銀行的傑夫‧米查姆。

Hi guys, thanks for taking the question. Another one on MariTide for Jay. You just -- post ADA, were there any changes that you guys made to Phase 3, just thinking increased entry criteria or maybe pace of titration just to optimize discontinuations? And then related, from a strategy perspective, let's say, to the current study, do they constitute the majority of Amgen's Phase 3 investment in MariTide? Or would you guys looking to expand more broadly into peripheral indications or (inaudible)? Thank you.

大家好，感謝你們回答這個問題。另一個是 Jay 在 MariTide 上的作品。您只是——在 ADA 之後，你們對第 3 階段做了什麼改變嗎，只是考慮增加進入標準或滴定速度以優化停藥？然後從策略角度來看，例如，就目前的研究而言，它們是否構成了安進對 MariTide 第三階段投資的大部分？或者你們是否希望更廣泛地擴展到外圍適應症或（聽不清楚）？謝謝。

Yes. Thanks, Geoff. The feedback after the ADA was quite strongly positive, especially from key opinion leaders, investigators in the field. And that for us was terrific to hear thought leaders present these data that we spent so much time with and get their unvarnished opinions was very positive. And no, there were no changes or edits to the Phase 3 program as a result of those engagements at ADA.

是的。謝謝，傑夫。ADA 之後的回饋非常積極，尤其是來自關鍵意見領袖和該領域研究人員的回饋。對我們來說，聽到思想領袖展示我們花費大量時間研究的這些數據並得到他們坦誠的意見是非常高興的。並且，ADA 的這些活動並未對第三階段計畫做出任何改變或編輯。

There was actually really strong confidence that I think is well reflected by the very strong enrollment that we're seeing on this trial right -- on these trials right now. We remain very interested in bringing MariTide to other obesity-related conditions. And the field is even suggesting some not overly obesity-related conditions to think about. And we'll have more to say on the broader MariTide Phase 3 program in due course.

我認為，實際上人們的信心非常強烈，這從我們在這次試驗中看到的非常強勁的報名人數就可以看出來——在這些試驗中。我們仍然非常有興趣將 MariTide 應用於其他肥胖相關疾病。這領域甚至提出了一些與肥胖無關的狀況供大家思考。我們將在適當的時候就更廣泛的 MariTide 第三階段計劃發表更多評論。

And Geoff, it's Murdo. I would just add that we're also looking to inform clinical practice as much as possible in chronic weight management. So anything we can do to help those clinicians upon approval, understand how to use MariTide in the real-world setting, we will continue to generate those data.

傑夫，我是默多。我想補充一點，我們也希望盡可能為慢性體重管理的臨床實踐提供資訊。因此，我們可以做任何事情來幫助那些獲得批准的臨床醫生了解如何在現實環境中使用 MariTide，我們將繼續產生這些數據。

Julianne, I think we've got time for one more question, and then Bob will wrap up the call

朱莉安，我想我們還有時間再問一個問題，然後鮑伯會結束通話

Carter Gould, Cantor Fitzgerald.

卡特古爾德、康托費茲傑拉。

Great. Good afternoon. Thanks for taking the question. For Bob or Murdo, wanted to ask on the policy front. We've seen IP under attack across the industry on multiple fronts, the most notably in the obesity space. Are you taking actions or advocating either on your own or in conjunction with peers to address persistent unlawful compounding? Or does Amgen now view compounding of the current wave of GLP-1s or as a general concept as a creeping direct or indirect threat to (technical difficulty)? Or is Amgen expected to fade as a concern by the time MariTide launches? Any thoughts would be appreciated. Thank you.

偉大的。午安.感謝您回答這個問題。對於鮑勃或默多，想從政策方面詢問。我們看到整個產業的智慧財產權在多個方面受到攻擊，最明顯的是在肥胖領域。您是否正在採取行動或單獨或與同行一起倡導解決持續存在的非法複合問題？或者安進現在是否認為當前 GLP-1 浪潮的複合效應或一般概念是對（技術難度）？或者，當 MariTide 上市時，安進 (Amgen) 是否會逐漸不再受到關注？任何想法都將不勝感激。謝謝。

Obviously, Carter, IP is a critical consideration in our industry, and we're very respectful of the importance of IP as the basis on which investments are made in this industry. Again, you know the drill, right? We invest a couple of billion dollars of research and development over 10 or 15 years and we need to have confidence in the IP that protects those investments.

顯然，卡特，智慧財產權是我們行業的一個重要考慮因素，我們非常尊重智慧財產權作為該行業投資基礎的重要性。再說一遍，你知道該怎麼做，對吧？我們在 10 到 15 年的時間裡投資了數十億美元用於研發，我們需要對保護這些投資的智慧財產權有信心。

But compounding is less a direct issue for Amgen because our molecule is an antibody, and it won't be compounded in the way that peptides and small molecules have been and can be in light of the statutes that are available to permit it.

但對安進來說，複合並不是一個直接問題，因為我們的分子是一種抗體，而且根據現有的法規，它不會像勝肽和小分子那樣進行複合。

But in general, I think we're pretty clear that compounding is not good for the industry, probably not good for patients. And we would be mindful of the importance of kind of quality framework that we have in place that the regulators routinely assess us on, and that's what gives us comfort that we're providing safe, reliable supply of medicines to our patients.

但總的來說，我認為我們很清楚複合對產業不利，可能對病人也不利。我們會牢記我們現有的品質框架的重要性，監管機構會定期對我們進行評估，這讓我們放心地為患者提供安全、可靠的藥品供應。

And Murdo, feel free to jump in if you want to add anything

Murdo，如果你想補充什麼，請隨意加入

No, I would concur. I think it's important to underscore that there isn't a compounding pathway for a biologic such as MariTide. And it's concerning that compounders continue to (Inaudible - microphone inaccessible) available despite the supply situation having been resolved by other manufacturers.

不，我同意。我認為需要強調的是，像 MariTide 這樣的生物製劑沒有複合途徑。令人擔憂的是，儘管其他製造商已經解決了供應問題，但複合材料製造商仍繼續（聽不清楚 - 麥克風無法使用）提供服務。

All right. Let me just address two things quickly before we thank you for joining us on the call. So first, just to highlight, again, I hope you got a clear sense from us that the business is performing well. And that's true across therapeutic categories and geographies. And our execution is also strong in operations and research and development. And of course, that's setting the stage for what we expect to be attractive long-term growth for the company.

好的。在感謝您參加我們的電話會議之前，請允許我快速講兩件事。首先，我要再次強調，我希望您能從我們這裡清楚地了解到業務表現良好。不論治療類別和地域，情況都是如此。而且我們在營運和研發方面的執行力也很強。當然，這為我們預期的公司實現長期有吸引力的成長奠定了基礎。

So again, excited about the performance. Looking forward to the second half of the year. But before we conclude today, I just want to share one organizational announcement, which is that Justin Claeys will be transitioning his IR responsibilities to our Treasurer, Adam Elinoff. Justin will be moving into a new role as the Head of Financial Planning and Analysis at Amgen. And that's an area where he has spent much of his 20-year career with us.

所以再次，我對這場演出感到興奮。期待下半年。但在今天結束之前，我只想分享一個組織公告，那就是賈斯汀·克萊斯 (Justin Claeys) 將把他的 IR 職責轉移給我們的財務主管亞當·埃利諾夫 (Adam Elinoff)。賈斯汀將擔任安進公司財務規劃和分析主管的新職位。他在與我們共事的 20 年職業生涯中大部分時間都在這個領域度過。

So we're looking forward to having him back in that leadership role. And thrilled that Adam, who's been with the company for nearly 19 years will take on the responsibility of Investor Relations in addition to his treasury role.

因此，我們期待他再次擔任領導職務。令人興奮的是，已在公司工作近 19 年的亞當除了擔任財務職務外，還將承擔投資者關係的職責。

So I'm confident that all of you will enjoy working with him and that it will be a seamless transition. And on behalf of Pete and the rest of the team, I want to thank Justin for the superb job that he's done in leading the Investor Relations effort.

因此我相信大家都會喜歡和他一起工作，而且這將是一個無縫的過渡。我代表皮特和團隊其他成員感謝賈斯汀在領導投資者關係工作方面所做的出色工作。

So thank you all for joining us, and we look forward to connecting with you at the next quarterly call.

感謝大家的參與，我們期待在下次季度電話會議上與您聯繫。

This concludes our Amgen Q2 2025 earnings conference call. You may now disconnect.

安進 2025 年第二季財報電話會議到此結束。您現在可以斷開連線。