Core Insights - Amgen's Imdelltra (tarlatamab-dlle) shows promising results in treating small cell lung cancer (SCLC), demonstrating a 40% reduction in the risk of death and extending median overall survival by more than five months compared to standard chemotherapy [1][2][5] Clinical Data - The global phase III DeLLphi-304 study reported a median overall survival of 13.6 months for patients treated with Imdelltra, compared to 8.3 months for the control group [3][5] - Imdelltra also exhibited a statistically significant improvement in median progression-free survival compared to standard-of-care chemotherapy [3][5] - The drug was well-tolerated, with most adverse events being mild to moderate in severity [4][5] Market Context - SCLC accounts for approximately 15% of over 2.4 million global lung cancer cases annually, with a low five-year survival rate of 5-10% across all stages [8] - Amgen's stock has increased by 10.7% year-to-date, contrasting with a 3.9% decline in the industry [4] Regulatory Approval - Imdelltra received FDA approval in 2024 for pre-treated extensive-stage SCLC patients under the accelerated approval pathway, marking it as the first DLL3-targeting BiTE therapy [9] - The drug generated sales of $81 million in Q1 2025, reflecting a 21% sequential increase driven by volume growth [10] Future Outlook - Continued approval of Imdelltra is contingent on the success of the ongoing phase III DeLLphi-304 study, which serves as the confirmatory study for the extensive-stage SCLC indication [10]

Breakthrough Second-Line Treatment Demonstrated Survival Advantage over Standard-of-Care Chemotherapy Late-Breaking Data Presented at ASCO 2025 and Simultaneously Published in The New England Journal of MedicineTHOUSAND OAKS, Calif., June 2, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new interim results from the global Phase 3 DeLLphi-304 trial showing IMDELLTRA® (tarlatamab-dlle) reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months ...

Company Overview - Amgen is a biotechnology company that discovers, develops, manufactures, and delivers innovative medicines to combat serious diseases [3] - The company has a broad and deep pipeline aimed at treating cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [3] - Amgen has been recognized as one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes in 2024 [4] Upcoming Events - Amgen will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20 a.m. ET [1] - The presentation will be made by Peter Griffith, CFO, and Murdo Gordon, EVP of Global Commercial Operations [1] - The webcast of the presentation will be available for replay for at least 90 days after the event [2]

Group 1 - Stride Inc. has been named "Stock to Study" by BetterInvesting Magazine for August 2025, indicating potential interest from investors regarding its valuation [1][2] - The upcoming report will provide comprehensive fundamental data on Stride, including sales, earnings, pre-tax profit, and return on equity [2] - The same issue will also feature a fundamental review of Amgen Inc., which is considered undervalued by the Editorial Advisory and Securities Review Committee [3] Group 2 - The Editorial Advisory and Securities Review Committee consists of several CFA members, indicating a level of expertise in their evaluations [3] - BetterInvesting is a nonprofit organization focused on investment education, having empowered over 5 million individuals since its inception in 1951 [5]

Core Viewpoint - The pharmaceutical industry is facing potential cost increases due to the U.S. tariff war, particularly affecting companies reliant on foreign manufacturing [1][2][3] Group 1: Impact of Tariffs on Pharmaceutical Companies - The U.S. has threatened a 25% import tariff on foreign-made drugs, which could push domestic production but also increase costs for companies [2][3] - Companies like Amgen, Pfizer, and AbbVie are particularly vulnerable due to their reliance on overseas manufacturing, especially in countries like Ireland [5][11][16] - The construction of new U.S. manufacturing facilities is costly and time-consuming, leaving companies exposed to rising costs and thin profit margins [3][10] Group 2: Company-Specific Vulnerabilities - **Amgen**: Heavily reliant on overseas production, particularly in Ireland and Singapore, which could become a liability if tariffs are imposed [7][8][9] - **Pfizer**: Significant production of top-selling drugs in Ireland and other European countries, with potential tariffs impacting about 10% of its total revenue [11][13][12] - **AbbVie**: While the company has not included tariff impacts in its guidance, analysts suggest it could face hundreds of millions in costs due to reliance on foreign manufacturing for bestsellers [17][18][19] Group 3: Financial Implications - Rising costs from tariffs could erode already thin profit margins across the pharmaceutical sector [10] - AbbVie is earmarking $10 billion for domestic manufacturing expansion over the next decade, indicating a significant financial commitment amid tariff uncertainties [20] - The company is also facing challenges in maintaining its dividend amidst ongoing patent wars and high advertising costs for its products [22]

Group 1 - The approach has received over 180 five-star reviews from members who are experiencing benefits [1] - The company invests significant resources, over $100,000 annually, into researching profitable investment opportunities [1] - The current environment is challenging for dividend investors, indicating a potential lack of preparedness [1] Group 2 - Samuel Smith has extensive experience as a lead analyst and Vice President at dividend stock research firms [2] - The High Yield Investor group focuses on balancing safety, growth, yield, and value in investment strategies [2] - The services offered include real-money portfolios, trade alerts, educational content, and an active investor chat room [2]

Core Insights - Amgen Inc. has reported a strong start to 2025, with first-quarter revenues increasing by 9% and non-GAAP earnings per share rising by 24% year-over-year, driven by 14 products that delivered double-digit growth across various therapeutic areas [3]. Company Performance - The company experienced broad-based strength in its portfolio, particularly in general medicine, rare disease, inflammation, and oncology [3]. - The macro and policy environment remains fluid, especially concerning taxes and pricing, but Amgen emphasizes the need for more innovation in healthcare [4]. Product Highlights - Specific product highlights were anticipated to be discussed by the Senior Vice President of Global Marketing & Access, indicating a focus on key growth drivers within the portfolio [5].

Summary of Amgen's Conference Call Company Overview - **Company**: Amgen - **Event**: RBC Global Healthcare Conference 2025 - **Key Speakers**: Justin Klaas (Head of Investor Relations), Kaveh Nixafed (Senior VP of Global Market and Access) Financial Performance - **Q1 2025 Revenue Growth**: Revenues increased by 9% year-over-year - **Non-GAAP Earnings Per Share**: Increased by 24% year-over-year - **Product Performance**: 14 products delivered double-digit growth across various therapeutic areas [3][4] Product Highlights - **General Medicine**: - Repatha and Avenity generated over $1 billion in Q1, up 28% year-over-year [5] - Significant potential for treating cardiovascular disease and osteoporosis [5] - **Obesity Treatment**: - Meridide is advancing with two Phase III studies in chronic weight management [6] - **Rare Disease**: - Oplisnow launched as the first FDA-approved therapy for IgG4 related disease, with a PDUFA date set for December 14 for generalized myasthenia gravis [6] - **Oncology**: - Progress in bispecific T cell engager platform with products like BLINCYTO and BELTRA [7] - **Biosimilars**: - Generated $735 million in Q1, up 35% year-over-year, with new launches like HavBlue and Weslana [7] Strategic Focus - **Innovation**: Emphasis on innovation as a top priority, with significant investments in R&D and capital expenditures [11][12] - **Market Access**: - Nearly 50% of commercial plans have Repatha on formulary without prior authorization, leading to a 42% volume growth year-over-year in the U.S. [18] - **Manufacturing**: - Global manufacturing footprint with substantial operations in the U.S., including facilities in Ohio, North Carolina, and Puerto Rico [16] Market Environment - **Macro and Policy Environment**: - Ongoing monitoring of tariffs, taxes, and pricing policies [4][11] - Engagement with policymakers to reinforce the value of U.S.-based innovation [11] Future Outlook - **Obesity Market**: - Anticipation of market fragmentation into subcategories, with a focus on differentiation for Meridide [26] - **Biosimilars Growth**: - Plans to expand the biosimilars portfolio with additional products and global markets [42][43] - **Capital Allocation**: - Focus on investing in innovation, followed by capital expenditures and returning value to shareholders [47] Additional Insights - **Patient Impact Expansion**: A disciplined framework for evaluating molecules for expansion opportunities based on scientific differentiation and existing clinical data [32] - **Rare Disease Strategy**: Emphasis on economies of scope to effectively serve patients with rare diseases [38] - **Biosimilars Integration**: The biosimilars business is seen as complementary to Amgen's core operations, enhancing overall business efficiency [44] This summary encapsulates the key points discussed during the conference call, highlighting Amgen's financial performance, product pipeline, strategic focus, and future outlook in the biopharmaceutical industry.

Core Viewpoint - Amgen's stock has faced a decline of 10.4% over the past three months, largely attributed to macroeconomic uncertainties and trade tensions [1][2]. Group 1: Market Environment - The stock market has experienced volatility due to President Trump's tariffs and China's retaliatory measures, although a recent deal has eased tensions temporarily [2]. - The uncertainty surrounding tariffs continues to impact economic growth, despite pharmaceuticals being exempt from initial tariffs [3]. Group 2: Company Performance - Amgen's revenues grew by 9% year over year in Q1 2025, driven by increased patient demand for innovative medicines [4]. - The company is facing declining revenues from oncology biosimilars and established products like Enbrel, with competitive pressures affecting sales [5]. - Key revenue drivers include older medicines like Prolia and Repatha, as well as new drugs such as Tavneos and Tezspire, alongside rare disease drugs from the acquisition of Horizon Therapeutics [5]. Group 3: Drug Pipeline and Approvals - Amgen is evaluating several drugs for additional indications, which could enhance revenue growth, with Uplizna recently approved for IgG4-related disease [6][7]. - The company has invested significantly in M&A to diversify its pipeline, including the development of MariTide, a novel obesity treatment [8][10]. - Clinical studies for MariTide have shown promising results, and further studies are ongoing [9][10]. Group 4: Biosimilars and Market Strategy - Amgen launched several new biosimilars in 2025, generating substantial sales, including Wezlana and Pavblu, which contributed to a 35% year-over-year increase in biosimilar sales [13][15]. - The company is actively pursuing additional biosimilar approvals to mitigate the impact of upcoming patent expirations for key drugs [15][16]. Group 5: Financial Outlook - Amgen's stock has outperformed the industry and S&P 500, with a year-to-date increase of 7.3% [18]. - The stock is reasonably valued, trading at a price/earnings ratio of 13.12, lower than the industry average [21]. - Earnings estimates for 2025 and 2026 have seen upward revisions, indicating positive market sentiment [24][26]. Group 6: Long-term Growth Potential - The company is expected to maintain long-term revenue growth driven by strong performance from key drugs and innovative medicines [27]. - Despite initial data from MariTide studies being below expectations, it holds potential as a significant product for Amgen [27].

证券研究报告 | 2025年05月21日 海外制药企业2025Q1业绩回顾 ——美国药品价格改革叠加不确定的宏观环境 行业研究 · 行业专题 医药生物 投资评级：优于大市（维持评级） 证券分析师：马千里 010-88005445 maqianli@guosen.com.cn S0980521070001 证券分析师：陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师：彭思宇 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 请务必阅读正文之后的免责声明及其项下所有内容 摘要 请务必阅读正文之后的免责声明及其项下所有内容 2 ◼ Pharma收入端增长整体有所放缓：2025Q1，礼来及诺和诺德在GLP-1类药物驱动下，收入端分别+45%/+18%，其中诺和诺德由于美 国compounded GLP-1药物影响，销售低于预期并下调全年收入指引；诺华、艾伯维、阿斯利康、赛诺菲分别依靠诺欣妥/可善挺、 Skyrizi/Rinvoq、Farxiga/Enhertu、Dupixent等核心品种 ...