Group 1: Amgen (AMGN.US) - Amgen's Imdelltra shows positive results in Phase 3 trial for small cell lung cancer, significantly extending patient survival compared to chemotherapy [2][3] - The trial involved 509 patients, with Imdelltra reducing the risk of death by 40%, leading to an average survival of 13.6 months versus 8.3 months for chemotherapy [2][3] - Imdelltra also demonstrated a 29% reduction in the risk of disease progression or death, with improved patient-reported symptoms and a lower incidence of severe adverse events compared to chemotherapy [3][2] - Goldman Sachs rates Amgen as "Buy" with a 12-month target price of $400, indicating a 38% upside potential from the June 3 closing price [3] Group 2: Regeneron Pharmaceuticals (REGN.US) - Regeneron's linvoseltamab shows promising results in Phase 1b LINKER-MM2 trial for relapsed/refractory multiple myeloma, achieving an 85% objective response rate (ORR) when combined with bortezomib [4][5] - The combination therapy demonstrated a 50% complete response rate (CR) and a 78% six-month progression-free survival (PFS) rate [4] - In another cohort with carfilzomib, linvoseltamab achieved a 90% ORR and a 76% CR rate, with an estimated 12-month PFS rate of 83% [7] - Goldman Sachs rates Regeneron as "Buy" with a 12-month target price of $804, indicating a 35% upside potential from the June 3 closing price [8] Group 3: Relay Therapeutics (RLAY.US) - Relay's RLY-2608 combined with fulvestrant shows encouraging results in treating PIK3CA-mutated HR+/HER2- advanced breast cancer, with a median PFS of 10.3 months [9][10] - The trial included 118 patients, with a clinical benefit rate of 67% and an objective response rate of 67% in patients with kinase mutations [9][10] - Goldman Sachs rates Relay as "Buy" with a 12-month target price of $11, indicating a 234% upside potential from the June 3 closing price [11]

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]

Core Insights - Amgen's IMDELLTRA® (tarlatamab-dlle) has shown a 40% reduction in the risk of death and an increase in median overall survival by over five months compared to standard-of-care chemotherapy for small cell lung cancer patients who have progressed after platinum-based chemotherapy [1][3][5] Group 1: Clinical Trial Results - The Phase 3 DeLLphi-304 trial met its primary endpoint of overall survival (OS) and key secondary endpoint of progression-free survival (PFS) [2][5] - Median OS for IMDELLTRA was 13.6 months compared to 8.3 months for standard chemotherapy, with a hazard ratio of 0.60 [1][3] - Median PFS was also significantly improved for IMDELLTRA at 4.2 months versus 3.7 months for standard chemotherapy, with a hazard ratio of 0.71 [3][5] Group 2: Patient Outcomes - IMDELLTRA significantly improved patient-reported outcomes related to cancer symptoms such as dyspnea and cough compared to the control arm [2] - The safety profile of IMDELLTRA was consistent with known profiles, showing lower rates of grade 3 or higher treatment-related adverse events (TRAEs) at 27% compared to 62% in the control arm [4][5] Group 3: Mechanism and Indication - IMDELLTRA is a first-in-class targeted immunotherapy designed to bind to DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells [6][7] - It is indicated for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have disease progression after platinum-based chemotherapy [7][8] Group 4: Industry Context - Small cell lung cancer (SCLC) is known for its aggressive nature, with a low five-year survival rate of 5-10% across all stages [8] - SCLC accounts for approximately 15% of the over 2.4 million lung cancer diagnoses globally each year [8]

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 - 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].

Investment Rating - The investment rating for the pharmaceutical industry is "Outperform" [2] Core Insights - Overall revenue growth for pharmaceutical companies has slowed down, with Eli Lilly and Novo Nordisk showing significant increases of 45% and 18% respectively in Q1 2025, while other companies like GSK and Merck faced low single-digit growth or declines [3][5] - The U.S. drug price reform and uncertain macroeconomic environment are impacting the industry, with the Trump administration's executive order promoting "Most Favored Nation" pricing potentially reducing the pricing power of large pharmaceutical companies [3][7] - The next five years will see several blockbuster drugs facing patent expirations, prompting pharmaceutical companies to pursue business development (BD) transactions to enhance revenue and fill pipeline gaps [3][13] Summary by Sections 01 Overview of Q1 2025 Performance - The top 15 pharmaceutical companies had a combined R&D expenditure of $31.8 billion in Q1 2025, reflecting a year-on-year increase of 0.6% [8] 02 Revenue and Guidance - Eli Lilly reported Q1 2025 revenue of $12.7 billion, a 45% increase year-on-year, with a full-year guidance of $58.0 billion to $61.0 billion [5] - Pfizer's revenue decreased by 6% to $13.7 billion in Q1 2025, with a full-year guidance of $61.0 billion to $64.0 billion [6] 03 Drug Price Reform and Macro Environment - The Trump administration's executive order aims to provide U.S. patients with "Most Favored Nation" pricing, which could pressure drug prices downward [7] - A proposed budget plan by the Republican party includes significant cuts to Medicaid, potentially impacting pharmaceutical revenues [7] 04 Upcoming Patent Expirations - Several key products are approaching patent expiration, including Eli Lilly's Tirzepatide and JNJ's Invega Sustenna, which could lead to increased competition and revenue challenges [13][14] 05 Recent Business Development Projects - Notable recent BD transactions include JNJ's acquisition of IntraCellular for $14.6 billion to enhance its pipeline in mental health treatments [15][16]

Core Viewpoint - Amgen and Bristol Myers Squibb are leading biotechnology companies with diverse portfolios, making it challenging to choose between them based on their fundamentals, growth prospects, challenges, and valuations [1][2]. Amgen (AMGN) - Amgen has a vast global footprint and a diverse portfolio, with growth products like Prolia, Xgeva, Evenity, Vectibix, Nplate, Kyprolis, and Blincyto stabilizing revenue despite declining sales from legacy drugs [3][4]. - Increased pricing pressures and competition from biosimilars are expected to negatively impact sales of Prolia and Xgeva starting in 2025 [4]. - Key drug Repatha is driving growth, and the approval of Tezspire for severe asthma has strengthened Amgen's portfolio [4][5]. - Amgen has promising candidates in its pipeline, including a broad phase III program on MariTide targeting obesity and type-II diabetes, with data readouts expected in the second half of 2025 [5]. - The acquisition of Horizon Therapeutics has expanded Amgen's rare disease business significantly [6]. - The Zacks Consensus Estimate for Amgen's 2025 sales indicates a year-over-year increase of 5.31%, with EPS expected to improve by 4.79% [13]. - Amgen's shares have gained 6.2% this year, trading at 13X forward earnings, indicating a higher valuation compared to BMY [16][17]. Bristol Myers Squibb (BMY) - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition for legacy drugs [7][8]. - Reblozyl has shown strong performance in the U.S. and international markets, expected to contribute significantly in the coming decade [7]. - Opdivo maintains momentum with consistent label expansions, and the recent FDA approval of Cobenfy for schizophrenia broadens BMY's portfolio [9][10]. - Despite newer drugs boosting sales, generic competition for legacy drugs has led to a 20% decline in legacy portfolio revenues in Q1 due to impacts from Revlimid and others [11]. - BMY's strategy of acquiring promising companies has resulted in substantial debt, with long-term debt at $46.1 billion as of March 31, 2025 [12]. - The Zacks Consensus Estimate for BMY's 2025 sales implies a year-over-year decrease of 4.10%, while EPS suggests a significant increase of 499.13% [14]. - BMY's shares have lost 15.5% this year, trading at a lower valuation of 7.10 for forward earnings [16][17]. Comparison and Conclusion - Both companies offer attractive dividend yields, with BMY at 5.30% and AMGN at 3.49% [20]. - AMGN is viewed as a better pick currently due to solid fundamentals and recent positive estimate revisions, despite its higher valuation [23].