Summary of Amgen's Conference Call Company Overview - **Company**: Amgen - **Industry**: Biotechnology and Pharmaceuticals - **Key Focus Areas**: Therapeutics for unmet medical needs, including cardiovascular diseases, osteoporosis, severe asthma, and rare diseases [2][3] Financial Performance - **2025 Revenue Growth**: 10% increase in revenues, driven by 14 blockbuster products [4] - **Earnings Growth**: 14% increase in earnings per share [4] - **Debt Reduction**: Over $6 billion in debt paid down in 2025 [6] Key Products and Growth Drivers - **Repatha**: - Annualized sales of approximately $3 billion, growing at 33% [7] - Demonstrated a 36% reduction in heart attack risk in primary prevention [5] - Significant market opportunity with over 100 million people at risk of heart attacks [9] - **Evenity**: - Sales growth of over 30%, targeting women at high risk of osteoporotic fractures [10] - Urgent need for treatment due to high mortality rates post-fracture [47] - **Tezspire**: - Innovative treatment for severe asthma and chronic rhinosinusitis with nasal polyps [10] - Strong clinical performance and potential for expansion into COPD and eosinophilic esophagitis [10] - **Biosimilars**: - 42% year-over-year sales growth, contributing $13 billion since entry into the market [15] - **Rare Disease Portfolio**: - Approached $5 billion in sales, with ongoing expansion into new indications [11] Pipeline and Future Prospects - **MariTide**: - Focused on obesity and type 2 diabetes, with six phase 3 studies initiated [19] - Potential for monthly or less frequent dosing, addressing treatment persistence issues [20][21] - **Olpazeran**: - Targets Lp(a) reduction, a significant risk factor for cardiovascular disease, with potential for 95%-100% reduction [38] - Expected to provide a long-acting treatment option for patients [39] - **Imdeltra**: - Bispecific T-cell engager for small cell lung cancer, showing promise in early lines of therapy [13] Market Dynamics and Strategic Focus - **Obesity Market**: - Anticipated growth due to increasing recognition of obesity as a chronic disease [29] - Amgen aims to position itself as a key player in this evolving landscape [30] - **Capital Allocation**: - Focus on investing in innovation and manufacturing capabilities to maintain competitive advantage [25] - **Technological Integration**: - Emphasis on incorporating technology and AI to enhance operational efficiency [24] Conclusion - Amgen is positioned for significant growth in 2026 and beyond, driven by a robust pipeline of innovative therapies and a strong financial foundation. The company is focused on addressing high unmet medical needs across various therapeutic areas, with a commitment to maintaining operational discipline and investing in future growth opportunities [27]

Core Insights - Amgen has acquired Dark Blue Therapeutics for approximately $840 million, enhancing its oncology pipeline [1][8] - The acquisition adds a preclinical small-molecule degrader targeting MLLT1/3 proteins associated with specific types of acute myeloid leukemia (AML) [2][8] - Amgen currently does not market any therapies for AML but has Blincyto approved for acute lymphoblastic leukemia (ALL) and is developing bispecific T-cell engagers for AML [3][8] Amgen's Oncology Pipeline - Amgen has a diverse oncology portfolio, including drugs like Blincyto, Imdelltra, Lumakras, Vectibix, Kyprolis, Nplate, and Xgeva [6] - Key candidates in its late-stage oncology pipeline include bemarituzumab for gastric cancer and xaluritamig for metastatic castrate-resistant prostate cancer [6] - Ongoing phase III studies are evaluating Imdelltra in small cell lung cancer and biosimilars for Opdivo, Keytruda, and Ocrevus [6] Competitive Landscape - Major competitors in the oncology space include Pfizer, AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers [9] - Pfizer's oncology sales account for about 28% of total revenues, with a 7% increase in the first nine months of 2025 [10] - AstraZeneca's oncology segment comprises around 43% of total revenues, with a 16% increase in sales during the same period [11] - Merck's Keytruda, a key oncology drug, generated $23.3 billion in sales in the first nine months of 2025, up 8% year over year [12] - Bristol-Myers' Opdivo accounts for approximately 20% of its total revenues, with sales rising 8% to $7.54 billion [13] - Johnson & Johnson's oncology sales represent around 27% of total revenues, with a 20.6% operational increase in the first nine months of 2025 [14]

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]

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 reported third-quarter 2025 adjusted earnings of $5.64 per share, exceeding the Zacks Consensus Estimate of $5.00 per share, with a year-over-year earnings increase of 1% driven by higher revenues despite increased operating costs and taxes [1] - Total revenues reached $9.6 billion, surpassing the Zacks Consensus Estimate of $8.9 billion, marking a 12% year-over-year increase [1] Revenue Breakdown - Total product revenues increased by 12% year-over-year to $9.17 billion, with volume growth of 14% offset by a 4% negative impact from pricing [2] - Other revenues amounted to $420 million, reflecting a 19.3% year-over-year increase [2] Key Drug Performance - Evenity sales reached $541 million, up 36% year-over-year, exceeding both the Zacks Consensus Estimate of $519 million and the model estimate of $463.9 million [3] - Repatha generated revenues of $794 million, a 40% year-over-year increase, beating the Zacks Consensus Estimate of $720 million and the model estimate of $672.2 million [3] - Prolia revenues were $1.14 billion, up 9% year-over-year, significantly surpassing the Zacks Consensus Estimate of $911 million and the model estimate of $812.8 million [4] - Xgeva delivered revenues of $539 million, flat year-over-year, but exceeded the Zacks Consensus Estimate of $428 million and the model estimate of $408.6 million [5] - Blincyto sales were $392 million, a 20% increase year-over-year, but missed the Zacks Consensus Estimate of $413 million [7] - Otezla sales were $585 million, up 4% year-over-year, beating the Zacks Consensus Estimate of $582 million but missing the model estimate of $648.2 million [8] - Enbrel revenues declined by 30% year-over-year to $580 million, missing the Zacks Consensus Estimate of $645 million but beating the model estimate of $530.4 million [9] - Tezspire recorded sales of $377 million, a 40% year-over-year increase, exceeding both the Zacks Consensus Estimate of $364 million and the model estimate of $270.6 million [10] Cost and Margin Analysis - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with adjusted operating expenses rising by 18% to $5.25 billion [14] - R&D expenses increased by 31% year-over-year to $1.89 billion, reflecting ongoing investment in the late-stage pipeline [14] Future Outlook - Amgen raised its 2025 revenue and earnings guidance, 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 [15] - The company anticipates continued growth from key drugs like Repatha, Evenity, Tezspire, and its biosimilar portfolio, although erosion from biosimilars of Prolia and Xgeva may offset some growth [21] Pipeline Developments - Amgen is advancing its obesity drug MariTide, which has shown strong efficacy in clinical studies, with six global phase III studies currently underway [16][17] - Enrollment has been completed in two phase III studies for MariTide, with ongoing studies for cardiovascular disease and heart failure [18]

Financial Data and Key Metrics Changes - Revenues increased by 12% year over year to $9.6 billion, driven by strong performance across key growth drivers [12][20] - Non-GAAP operating margin was reported at 47%, reflecting significant investments across the business [12][15] - Free cash flow generated in the third quarter was $4.2 billion, indicating operational momentum [15] Business Line Data and Key Metrics Changes - Repatha sales reached $794 million, up 40% year over year, now annualizing at approximately $3 billion [20] - Evenity delivered $541 million in sales, a 36% increase year over year, with a 44% growth in the U.S. [22] - The rare disease portfolio grew 13% year over year to $1.4 billion, now annualizing at over $5 billion [24] - Oncology portfolio generated $2.3 billion in sales, growing 9% year over year [27] Market Data and Key Metrics Changes - The biosimilar portfolio saw sales increase by 52% year over year to $775 million, now annualizing at $3 billion [28] - Uplizna sales increased 46% year over year to $155 million, with significant uptake among rheumatologists [24] Company Strategy and Development Direction - The company is focused on expanding access to medicines through initiatives like Amgen Now, which offers Repatha at a significantly reduced price [5][22] - Continued investment in manufacturing with over $3 billion planned for the U.S. in 2025, building on over $40 billion since 2017 [7][12] - The company aims to drive innovation in areas of high unmet medical need while maintaining rigorous financial discipline [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining long-term growth, supported by a broad base of innovative medicines [4][11] - The company raised its 2025 guidance for total revenues to a range of $35.8-$36.6 billion and non-GAAP earnings per share between $20.60 and $21.40 [17] - Management highlighted the importance of the Vesalius CV study results for Repatha, which demonstrated significant cardiovascular event reduction [58][60] Other Important Information - The company is actively engaging with policymakers to support policies that improve access and protect innovation [10] - The launch of Uplizna in new indications is anticipated, with a PDUFA date set for December 14, 2025 [33] Q&A Session Summary Question: Confidence in Olpasiran and Business Development Approach - Management remains confident in Olpasiran's potential, citing strong genetic and epidemiological data supporting its efficacy [44] - The return to pre-Horizon debt levels does not significantly impact the company's business development strategy, which remains focused on earlier-stage opportunities [45][46] Question: 2026 Guidance and R&D Expenses - Key growth drivers will influence the top line, with a focus on maintaining industry-leading margins while investing in R&D [50][52] - R&D expenses are expected to stabilize after a significant increase over the past year, with ongoing investments in late-stage programs [51] Question: Vesalius CV Results Impact - The Vesalius CV study is expected to significantly enhance Repatha's market opportunity, with a focus on improving cardiovascular care [58][60] - Management emphasized the importance of the study's findings for primary care physicians and the broader healthcare community [61] Question: New Biosimilar Guidance Impact - The new FDA biosimilar guidance does not change the company's strategic focus on biosimilars, which continue to be a strong growth area [65] - The company is well-positioned to adapt to any new regulatory requirements while maintaining competitiveness in the biosimilar market [66][67]

Financial Data and Key Metrics Changes - Revenues increased by 12% year over year to $9.6 billion, driven by strong performance across key growth drivers [10][18] - Non-GAAP operating margin was reported at 47%, reflecting significant investments across the business [11] - Free cash flow generated in the third quarter was $4.2 billion, indicating operational momentum [12] Business Line Data and Key Metrics Changes - Repatha sales reached $794 million, up 40% year over year, now annualizing at approximately $3 billion [18] - Evenity delivered $541 million in sales, a 36% increase year over year, with a 44% growth in the U.S. [20] - The rare disease portfolio grew 13% year over year to $1.4 billion, with Uplizna sales increasing 46% to $155 million [23] - Tezspire sales rose 40% year over year to $377 million, achieving over $1 billion in sales year to date [25] - The oncology portfolio generated $2.3 billion in sales, growing 9% year over year [26] Market Data and Key Metrics Changes - The biosimilar portfolio saw sales increase by 52% year over year to $775 million, now annualizing at $3 billion [27] - Evenity holds over 60% market share in the U.S. bone builder segment, with significant untapped potential [21] - Repatha is now accessible to over 95% of insured patients in the U.S., with most paying less than $50 out of pocket [19] Company Strategy and Development Direction - The company is focused on expanding access to medicines through initiatives like Amgen Now, which offers Repatha at a significantly reduced price [20] - Continued investment in manufacturing with over $3 billion planned for the U.S. in 2025, building on over $40 billion since 2017 [5] - The company aims to drive innovation in areas of high unmet medical need while maintaining rigorous financial discipline [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining long-term growth, supported by a broad base of innovative medicines [3] - The company raised its 2025 revenue guidance to a range of $35.8-$36.6 billion and non-GAAP earnings per share to between $20.60 and $21.40 [15] - Management highlighted the importance of the Vesalius CV study results for Repatha, which could significantly impact cardiovascular care [57][59] Other Important Information - The company plans to continue leveraging AI across various stages of the value chain to enhance productivity [12] - Capital expenditures for 2025 are expected to be approximately $2.2-$2.3 billion, focusing on expanding network capacity [13] Q&A Session Summary Question: Confidence in Olpasiran and Business Development Approach - Management remains confident in Olpasiran's potential, emphasizing its best-in-class properties and the importance of the Ocean A study [42][43] - The return to pre-Horizon debt levels does not significantly alter the company's approach to business development, which remains focused on earlier-stage opportunities [44] Question: 2026 Guidance and R&D Expenses - Management discussed key growth drivers and the focus on maintaining industry-leading margins while investing in R&D [46][49] - R&D expenses are expected to stabilize after a significant increase, with ongoing investments in late-stage programs [50][51] Question: Vesalius CV Results Impact - The Vesalius CV study is anticipated to enhance Repatha's market opportunity, with management highlighting its significance in preventing first cardiovascular events [54][57] - The study's results will be shared at the upcoming AHA meeting, emphasizing the need for improved cardiovascular care [59][60] Question: New Biosimilar Guidance Impact - The company does not foresee a change in its strategic focus on biosimilars, viewing the market as performing well despite new guidance [63][66] - Management remains committed to competing effectively in the biosimilar space, regardless of regulatory changes [64][65]

Core Insights - Amgen (AMGN) is set to report its third-quarter 2025 results on November 4, with earnings expected to be $5.00 per share and sales at $8.94 billion, reflecting a 14.5% earnings surprise in the last quarter [1][9] Sales Performance - Strong volume growth from products like Evenity, Repatha, and Blincyto is anticipated to drive sales, with consensus estimates for these products at $519 million, $720 million, and $413 million respectively [2] - The company's own estimates for Evenity, Repatha, and Blincyto are slightly lower at $463.9 million, $672.2 million, and $395.5 million respectively [3] - Sales of RANKL antibodies, Prolia, and Xgeva are expected to decline significantly due to patent expirations and the launch of three biosimilars in the U.S. market [4] New Product Contributions - Newer drugs such as Imdelltra, Tavneos, and Tezspire are projected to contribute positively to top-line growth, with consensus estimates for Tezspire and Tavneos at $364 million and $119 million respectively [5] - The company's estimates for Tezspire and Tavneos are $270.6 million and $120.7 million respectively [5] Competitive Pressures - Kyprolis is expected to face continued competitive pressure, with consensus sales estimates at $374 million and the company's estimate at $372.6 million [6] - Enbrel sales are likely to decline due to price reductions, while Otezla is expected to benefit from volume growth, with consensus estimates for Otezla at $582 million and Enbrel at $645 million [6] Recent Acquisitions - Sales of rare disease drugs Tepezza, Krystexxa, and Uplizna, acquired from Horizon in October 2023, showed improvement in the second quarter and are expected to continue this trend [7] Biosimilar Market Impact - Lower revenues from oncology biosimilars and legacy products are anticipated, although newer biosimilars like Wezlana and Pavblu may contribute to sales growth [8][10] Financial Outlook - Higher R&D costs are likely to impact operating margins negatively in the third quarter [11] - Amgen's earnings surprise history shows a strong performance, with an average surprise of 11.75% over the last four quarters [12] Earnings Prediction - The current Earnings ESP for Amgen is -1.25%, indicating uncertainty regarding an earnings beat this quarter [14]