Amgen Inc. (AMGN), headquartered in Thousand Oaks, California, discovers, develops, manufactures, and delivers human therapeutics. With a market cap of $176.4 billion, the company focuses on human therapeutics and develops novel medicines based on cellular and molecular biology. The drug manufacturing giant is expected to announce its fiscal fourth-quarter earnings for 2025 in the near term. Ahead of the event, analysts expect AMGN to report a profit of $4.74 per share on a diluted basis, down 10.7% from ...

Industry Overview - The drug and biotech sector has shown recovery after a weak first half, with large drugmakers signing pricing agreements with the Trump administration [1] - Dealmaking activity surged in the second half, boosting investor confidence, with the Large Cap Pharmaceuticals industry outperforming the S&P 500 in the past three months [1][4] - Innovation is at its peak, particularly in areas like obesity, cell and gene therapy, and next-gen oncology treatments, attracting investor attention [2] - Despite headwinds such as pipeline setbacks and regulatory risks, the outlook for growth in 2026 remains favorable due to rapid innovation and increased use of AI in drug development [2] Eli Lilly - Eli Lilly has achieved significant success with its tirzepatide medicines, including diabetes drug Mounjaro and weight loss medicine Zepbound, which are key revenue drivers [6][7] - Strong sales growth in 2025 is attributed to international market launches and improved production, with continued demand expected in 2026 [7] - Lilly is investing in obesity treatments with new molecules in clinical development, including orforglipron and retatrutide, with regulatory applications filed for orforglipron [8][9] - Despite challenges like declining product prices and competition in the GLP-1 market, Lilly's stock has risen 39.3% year to date, with 2026 earnings estimates improving from $30.78 to $33.61 per share [10] Johnson & Johnson - J&J has shown strong operational performance in 2025, with double-digit revenue growth from key brands despite the loss of exclusivity for Stelara [11] - The Innovative Medicine segment is expected to accelerate growth in 2026, driven by key products and new launches [12] - J&J's MedTech business has improved, with growth driven by acquired cardiovascular businesses and new product launches expected to contribute to 2026 growth [13][14] - The company has advanced its pipeline significantly and is on an acquisition spree, with a Zacks Rank of 2 (Buy) and a stock rise of 43.3% year to date [17] AbbVie - AbbVie faces declining sales from Humira due to loss of exclusivity but has successfully launched new immunology medicines Skyrizi and Rinvoq, generating combined sales of $18.5 billion in the first nine months of 2025 [18][19] - Strong market growth and new indications for these drugs are expected to drive future growth, alongside contributions from newer drugs [20] - AbbVie anticipates a high single-digit CAGR through 2029, supported by robust performance from Skyrizi and Rinvoq, with a Zacks Rank of 3 and a stock rise of 28.2% year to date [21][22] Amgen - Amgen's revenue growth is driven by key medicines like Repatha and new biosimilars, compensating for declines from mature drugs [23][24] - The company is focusing on obesity treatments with its candidate MariTide, which differentiates itself with a convenient dosing method [24] - Amgen's stock has risen 27.3% year to date, with 2026 earnings estimates increasing from $21.43 to $21.62 per share [25] AstraZeneca - AstraZeneca has several blockbuster drugs exceeding $1 billion in sales, with newer products contributing to growth despite losses from mature brands [26][27] - The company expects to achieve industry-leading top-line growth through 2030, with plans to launch 20 new medicines and generate $80 billion in total revenues [28] - AstraZeneca faces challenges such as competition and regulatory impacts but maintains a stable earnings estimate of $5.15 per share for 2026, with a stock rise of 10.7% year to date [29][30]

Core Insights - Amgen reported strong Q3 2025 earnings, with adjusted earnings of $5.64 per share, surpassing the Zacks Consensus Estimate of $5.00, and total revenues of $9.6 billion, exceeding the estimate of $8.9 billion, reflecting a 12% year-over-year increase [2][3] Financial Performance - Total product revenues increased by 12% year-over-year to $9.17 billion, driven by a 14% rise in volume, although partially offset by a 4% decline in pricing [3] - Other revenues rose by 19.3% year-over-year to $420 million, primarily due to higher royalty income [3] - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with operating expenses increasing by 18% to $5.25 billion [22] Key Product Performance - Prolia revenues reached $1.14 billion, up 9% year-over-year, significantly exceeding the Zacks Consensus Estimate of $911 million [6] - Evenity sales grew by 36% year-over-year to $541 million, surpassing the Zacks Consensus Estimate of $519 million [7] - Repatha generated revenues of $794 million, a 40% increase year-over-year, beating the Zacks Consensus Estimate of $720 million [7] - Biosimilar portfolio sales surged by 52% year-over-year to $775 million [5] Guidance and Outlook - Amgen raised its 2025 revenue and earnings outlook, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [24] - Adjusted operating margin is anticipated to be around 45%, with R&D expenses expected to grow at a mid-20s percentage rate year-over-year [25] Pipeline Developments - Enrollment has been completed in two phase III studies for MariTide, with approximately 5,000 adults enrolled [27] - Ongoing enrollment in two other phase III studies for atherosclerotic cardiovascular disease and heart failure [28]

Financial Data and Key Metrics Changes - The company reported a 10% revenue growth through the first nine months of the year, with product sales growth at 11% driven by a 14% volume growth [9][10] - In Q3, revenue growth was 12%, also driven by 14% volume growth, indicating strong momentum in the business [10] - Non-GAAP research and development expenses increased by 31% year over year in Q3, with a total of approximately $200 million spent on business development [12] Business Line Data and Key Metrics Changes - Repatha experienced a 30% year-over-year growth over the first nine months, with significant potential for future growth due to low penetration rates in the PCSK9 therapy market [13] - Evenity also grew by 30% year over year, holding a 60% market share in the U.S. bone builder market, with a large untapped patient population [14] - Tezspire achieved a remarkable 50% growth year over year, reaching $1 billion in sales in the U.S. for severe asthma [14] - The rare disease portfolio is annualizing at nearly $5 billion, growing 12% year over year, with Uplizna growing 50% year over year [15] - The innovative oncology segment grew by 11% year over year, driven by products like Blincyto and Imdeltra [15] Market Data and Key Metrics Changes - The company noted that the penetration rates for PCSK9 therapy remain low, indicating significant growth opportunities in the market [13] - The rare disease market is expanding, particularly for Uplizna, which has seen increased usage in IgG4-related diseases [15] Company Strategy and Development Direction - The company is focused on a volume-driven growth strategy, investing in innovation and science to enable longer, healthier lives [11] - Capital allocation priorities emphasize innovation, with a mid-20% allocation to R&D and a capital expenditure guide of $2.2 billion to $2.3 billion for the year [27][30] - The company is actively engaging with the government on pricing and access issues, aiming to enhance affordability for patients [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum of the business and pipeline, highlighting the importance of innovation in the current environment [11][27] - The company anticipates increased competitive intensity in the biosimilar market, particularly for Prolia and Xgeva, but expects growth from its six major growth drivers [46][47] Other Important Information - The company is exploring opportunities in rare diseases and remains open to business development activities, including licensing and acquisitions [55] - The company has launched Amgen Now, a direct-to-consumer program aimed at increasing access to Repatha [32][40] Q&A Session Summary Question: What are the expectations for the impact of biosimilars on Prolia and Xgeva? - Management expects competitive intensity to increase, leading to revenue declines for Prolia and Xgeva, but anticipates growth from other product lines to offset this erosion [46][47] Question: How is the company navigating the pricing and access landscape? - The company has a history of successfully navigating pricing and access issues and remains confident in its ability to manage these challenges moving forward [36] Question: What is the company's strategy regarding rare diseases? - The company is pleased with its entry into the rare disease market and is open to further opportunities in this area, leveraging its existing capabilities [49][55]

Financial Data and Key Metrics Changes - The company reported a 10% revenue growth through the first nine months of the year, with product sales growth at 11% driven by a 14% volume growth [10] - In Q3, revenue growth was 12%, also driven by 14% volume growth, indicating strong momentum in the business [10][11] - Non-GAAP research and development expenses increased by 31% year-over-year in Q3, with a total of approximately $200 million spent on business development [12] Business Line Data and Key Metrics Changes - Repatha experienced a 30% year-over-year growth over the first nine months, with significant potential for future growth due to low penetration rates in the PCSK9 therapy market [13] - Evenity also grew by 30% year-over-year, holding a 60% market share in the U.S. bone builder market, with a large untapped patient population [14] - Tezspire achieved 50% year-over-year growth, surpassing $1 billion in sales in the U.S. for severe asthma [14] - The rare disease portfolio is annualizing at close to $5 billion, growing 12% year-over-year, with Uplizna growing 50% year-over-year [15] - The innovative oncology segment grew by 11% year-over-year, driven by products like Imdeltra and Blincyto [15] Market Data and Key Metrics Changes - The company noted that the penetration rates for PCSK9 therapy remain low, indicating significant growth opportunities in the market [13] - The competitive intensity in the biosimilar market is expected to increase, particularly for Prolia and Xgeva, which may lead to revenue declines [43] Company Strategy and Development Direction - The company is focused on a volume-driven growth strategy, investing in innovation and science to enable longer, healthier lives [11] - Capital allocation priorities emphasize innovation, with a mid-20% allocation to R&D and a capital expenditure guide of $2.2-$2.3 billion for the year [26][29] - The company is actively engaging with the current administration regarding pricing and access policies, aiming to enhance affordability for patients [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum of the business and pipeline, highlighting the importance of innovation in the current environment [11][26] - The company anticipates continued growth from its six major growth drivers, including Repatha, Evenity, Tezspire, and its rare disease portfolio [15][45] - Management acknowledged the challenges posed by increasing competition in the biosimilar market but remains optimistic about offsetting these challenges with growth from other segments [43][45] Other Important Information - The company is exploring opportunities in rare diseases and remains open to business development activities, including licensing and acquisitions [52] - The direct-to-consumer program, Amgen Now, was introduced to enhance access to Repatha, reflecting a strategic move towards consumer engagement [30][38] Q&A Session Summary Question: What are the expectations for the impact of biosimilars on Prolia and Xgeva? - Management expects competitive intensity to increase, leading to revenue declines for Prolia and Xgeva, but anticipates different erosion curves for each product due to their market dynamics [43][44] Question: How does the company view its position in the rare disease market? - Management expressed satisfaction with its entry into the rare disease market and sees significant opportunities for growth, leveraging its existing capabilities [46][52] Question: What is the company's strategy regarding Maritide and its potential in other indications? - The company is monitoring the field for opportunities to expand Maritide's use beyond obesity and diabetes, considering its potential in related comorbidities [60][62]

Financial Data and Key Metrics Changes - The company reported a 10% revenue growth through the first nine months of the year, with product sales growth at 11% driven by a 14% volume growth [9][10] - In Q3, revenue growth was 12%, also driven by 14% volume growth, indicating strong momentum in the business [9][10] - Non-GAAP research and development expenses increased by 31% year over year in Q3, with a total of approximately $200 million spent on business development [12][28] Business Line Data and Key Metrics Changes - Repatha experienced a 30% year-over-year growth over the first nine months, with significant potential for future growth due to low penetration rates in the PCSK9 therapy market [13] - Evenity also grew by 30% year over year, holding a 60% market share in the bone builder market in the US, with a large untapped patient population [13] - Tezspire achieved 50% year-over-year growth, surpassing $1 billion in sales in the US for severe asthma [14] - The rare disease portfolio is annualizing at close to $5 billion, growing 12% year over year, with Uplizna growing 50% year over year [15] Market Data and Key Metrics Changes - The biosimilar portfolio grew by 40% year over year, now annualizing at approximately $3 billion, with cumulative revenues of $13 billion since inception [15] - The company expects increasing competitive intensity in the biosimilar market, particularly for Prolia and Xgeva, which may lead to revenue declines [43][44] Company Strategy and Development Direction - The company emphasizes innovation as its top capital allocation priority, with a focus on internal and external growth opportunities [26][28] - The company is actively engaging with the current administration regarding pricing and access policies, aiming to enhance affordability for patients [31][32] - The company is exploring opportunities in rare diseases, indicating a strong interest in expanding its portfolio in this area [48][57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum of the business and pipeline, highlighting the importance of volume-driven growth strategies [9][10] - The company remains optimistic about the long-term growth outlook, driven by its therapeutic areas and ongoing investments in innovation [10][12] - Management acknowledged the challenges posed by increasing competition in the biosimilar market but believes that growth drivers in other areas will offset these challenges [46] Other Important Information - The company is preparing for upcoming PDUFA dates, particularly for Uplizna, which is expected to drive further growth [15] - The company is focused on expanding its manufacturing capabilities to support the increased volume growth [29][30] Q&A Session Summary Question: What is Amgen's current position regarding agreements with the administration on manufacturing and pricing? - The company is actively engaging with the administration and has had positive relations, emphasizing its commitment to innovation and affordability for patients [31][32] Question: How does the company view the competitive landscape for Maritide in the obesity and diabetes space? - The company is confident in its ability to navigate pricing and access challenges, leveraging its experience from previous product launches [35][39] Question: What are the expectations for the denosumab biosimilar market? - The company anticipates increased competitive intensity and revenue declines for Prolia and Xgeva, but expects growth from other product lines to offset these declines [43][44] Question: How does the company plan to approach business development in rare diseases? - The company is open to various business development strategies, including licensing and acquisitions, to expand its rare disease portfolio [48][57]

Amgen FY Conference Summary Company Overview - **Company**: Amgen (NasdaqGS:AMGN) - **Date of Conference**: December 03, 2025 - **Focus**: Discussion on financial performance, product pipeline, and market dynamics Key Points Financial Performance - Amgen reported a **10% revenue growth** for the first nine months of 2025, with **11% product sales growth** driven by **14% volume growth** [2][3] - **12 products** experienced double-digit growth, and **14 products** are annualizing at over **$1 billion** [3] - The company successfully reduced debt related to the acquisition of Horizon, achieving this a quarter early [4] Growth Drivers - Key growth drivers identified include: - **Repatha**: Grew over **30% year-over-year**, now annualizing at nearly **$3 billion** [6] - **Evenity**: Achieved **30% year-over-year growth**, leading the bone builder segment with over **60% market share** in the U.S. [7] - **Tezspire**: Grew nearly **50% year-over-year**, exceeding **$1 billion** year-to-date [7] - **Rare Disease Portfolio**: Annualizing at almost **$5 billion**, with a **12% year-over-year growth** [8] - **Innovative Oncology Portfolio**: Grew **11% year-over-year**, with Imdeltra becoming a standard of care in small cell lung cancer [9] - **Biosimilars Portfolio**: Grew over **40% year-over-year**, now annualizing at roughly **$3 billion** [10] Pipeline Updates - **Repatha**: Significant cardiovascular outcomes data showing a **25% reduction in MACE** and a **36% reduction in heart attacks** [11] - **MariTide**: Ongoing studies in obesity and type 2 diabetes, with updates expected in the new year [12][63] - **Olpasiran**: In phase 3 development, showing promise in Lp(a) lowering therapy [12] - **Xaluritamig**: Progressing in phase 3 studies for prostate cancer [12] Market Dynamics - The company anticipates competition from oral PCSK9 inhibitors but believes the overall market for LDL-C treatment is underpenetrated, with over **100 million patients** globally not at their LDL-C goal [33][40] - Amgen's access strategies for Repatha include a direct-to-patient program priced at **$239 per month**, with low copays for insured patients [34] Competitive Landscape - The entry of biosimilars for Prolia and Xgeva is expected to impact sales, with a sharper decline anticipated for Xgeva due to consolidated buying power in oncology [20] - Amgen is confident in maintaining market share and growth despite new entrants, citing strong data and physician acceptance [35][39] Future Outlook - Amgen plans to continue investing in innovation, with a research and development budget expected to grow in the mid-20s percentage year-over-year [4] - The company is optimistic about its growth trajectory into 2026, supported by its six identified growth drivers [18][25] Additional Insights - The company is preparing for the launch of Uplizna in generalized myasthenia gravis, with a PDUFA date set for December 14 [18] - The management emphasized the importance of maintaining competitive pricing and access strategies in the evolving market landscape [55] This summary encapsulates the key discussions and insights from the Amgen FY Conference, highlighting the company's strong performance, growth strategies, and future outlook in the biopharmaceutical industry.

Core Insights - Amgen's stock has increased nearly 16% in one month due to strong Q3 2025 results, with both revenue and earnings surpassing expectations, and the company has raised its sales guidance for the year [1][10] - The drug and biotech sector has shown recovery, with major companies like Pfizer and AstraZeneca entering pricing agreements with the Trump administration, which may lead to a sustainable sector recovery [2][3] Financial Performance - Amgen's revenues grew by 10.5% in the first nine months of 2025, driven by strong demand for its innovative medicines [4] - Key drugs such as Repatha, Evenity, and new products like Tavneos and Tezspire are significantly contributing to revenue growth, alongside biosimilars [5][7] - Biosimilars generated approximately $2.2 billion in sales in the first nine months of 2025, with annualized sales expected to reach around $3 billion [17] Product Pipeline - Amgen is focusing on expanding the indications for several key drugs, which could further enhance revenue growth [6][7] - The company is developing MariTide, an obesity treatment, which has shown promising results in clinical studies and is expected to differentiate itself from competitors [8][9][11] - Ongoing phase III studies for MariTide and other candidates could provide important catalysts for future growth [12][14] Market Position and Valuation - Amgen's stock has outperformed the industry and S&P 500, with a year-to-date increase of 32.5% compared to 17.7% for the industry [22] - The stock is currently trading at a price/earnings ratio of 15.97, which is lower than the industry average of 17.26, indicating reasonable valuation [25] - Consensus estimates for earnings have been revised upward for 2025 and 2026, reflecting positive market sentiment [28][30] Challenges and Competitive Landscape - The expiration of patents for key drugs like Prolia and Xgeva is expected to lead to revenue erosion due to the introduction of biosimilars [19] - Pricing pressures from Medicare Part D redesign and the Inflation Reduction Act may adversely impact sales of certain drugs [20]

Group 1: NVIDIA Corp. (NVDA) - NVIDIA's shares have outperformed the Zacks Semiconductor - General industry year-to-date, with a growth of +35.9% compared to +34.2% [4] - The company is benefiting from strong growth in artificial intelligence (AI) and high-performance accelerated computing, particularly in data center revenues driven by demand for generative AI and large language models using its GPUs [4] - Collaborations with over 320 automakers and tier-one suppliers are enhancing NVIDIA's presence in the autonomous vehicle sector [5] - A limited supply of Blackwell GPUs may hinder NVIDIA's ability to meet demand, and rising production costs for complex AI systems could negatively impact margins [6] Group 2: AT&T Inc. (T) - AT&T's shares have outperformed the Zacks Wireless National industry year-to-date, with a growth of +17.6% compared to +3.7% [7] - The company is expected to benefit from a customer-centric business model and solid wireless traction, supported by an integrated fiber expansion strategy and steady 5G deployments [7] - AT&T aims to deploy Open RAN for 70% of its wireless network traffic by late 2026 and plans to pass over 50 million fiber locations by the end of 2030 [8] - The wireline division is facing challenges with persistent losses in access lines due to competitive pressures, and high debt levels remain a concern [9] Group 3: Amgen Inc. (AMGN) - Amgen's shares have outperformed the Zacks Medical - Biomedical and Genetics industry year-to-date, with a growth of +32.5% compared to +19.9% [10] - The company exceeded third-quarter estimates for both earnings and sales, driven by key medicines like Evenity, Repatha, and newer products like Tavneos and Tezspire [10] - New biosimilar launches are contributing to Amgen's top-line growth, although increased pricing pressures and competition are negatively impacting sales of several products [11] - Sales of best-selling drugs Prolia and Xgeva are expected to decline due to biosimilar competition, and recent pipeline setbacks pose additional concerns [11]

Core Insights - Amgen Inc. is a leading biopharmaceutical company with a market capitalization of approximately $180 billion, making it one of the largest biotech firms globally [1][2] Stock Performance - Amgen's shares have decreased by 3.3% from the 52-week high of $345.84, reached on November 13 [3] - Over the past three months, AMGN stock has increased by roughly 13.8%, outperforming the NASDAQ Composite, which gained 6.2% during the same period [3] - In the longer term, AMGN stock has gained 13.5% over the past 52 weeks and 28.3% year-to-date (YTD) [4] - The NASDAQ Composite has risen 20% over the same 52-week period and 18.4% YTD [4] - AMGN stock has shown significant momentum, trading above the 50-day and 200-day moving averages since early October [4] Financial Performance - The strong Q3 2025 earnings report, released on November 4, showed revenues increasing by 12% year-over-year (YoY) to $9.6 billion, driven by double-digit sales growth across 16 key products [5] - The growing demand for newer medicines such as Repatha, Tezspire, Evenity, and other rare disease drugs has contributed to the top-line strength [5] - Non-GAAP EPS increased by 1% YoY to $5.64 [5] Competitive Landscape - In contrast, rival Bristol-Myers Squibb Company has seen a pullback of 18.9% over the past 52 weeks and a decline of 15.6% YTD, significantly lagging behind Amgen's performance [6] - Amgen stock has a consensus rating of "Moderate Buy" from 32 analysts, surpassing the mean price target of $325.04 [6]