Core Insights - High-rolling investors are bullish on Amgen (NASDAQ:AMGN), indicating potential privileged information influencing their trading decisions [1] - The sentiment among major traders is predominantly bullish, with 75% of options trades being calls and only 0% bearish [2] - Significant price targets for Amgen have been identified, ranging from $290.0 to $400.0 over the last three months [3] Options Trading Activity - A total of 8 options trades were detected for Amgen, with a notable imbalance favoring calls over puts [1][2] - The total trade price for the identified options includes $422,130 for calls and $30,600 for a put [2] - Recent options trades include various strike prices, with significant trades such as a bullish call for $400.00 expiring on January 16, 2026, totaling $180.6K [8] Company Overview - Amgen is a leader in biotechnology, known for its therapeutics including Epogen, Neupogen, and Enbrel, among others [9] - The company has expanded its portfolio through acquisitions and recent drug launches, including treatments for cancer and rare diseases [9] - Amgen's current market position is supported by expert ratings, with an average target price of $314.67 from three analysts [11][12] Current Market Status - Amgen's stock is currently trading at $337.81, reflecting a 0.45% increase [14] - The stock's trading volume is reported at 163,220, with RSI readings suggesting it may be overbought [14] - Anticipated earnings release is scheduled in 82 days, which may impact future trading activity [14]

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]

Corporate Earnings Drive Pre-Market Activity - Amgen Inc. reported a 12% increase in total revenues to $9.6 billion and non-GAAP EPS of $5.64, exceeding forecasts and leading to a 3% rise in stock [3] - Lumentum Holdings Inc. saw a 17% stock increase after reporting Q3 2025 EPS of $0.57 on revenues of $425.2 million, driven by growth in its Cloud and Networking segment [4] - Rivian Automotive, Inc. reported Q3 2025 revenues of $1.56 billion, surpassing estimates, with a narrower loss per share of -$0.65 and a 47% year-over-year increase in automotive sales [5] - Johnson Controls International plc reported an adjusted EPS of $1.05 and sales of $6.1 billion, representing a 6% organic increase year-over-year, with an 11% growth in backlog [6] - The New York Times Company added 460,000 digital-only subscribers, boosting total revenue by 9.5% year-over-year to $700.8 million [7] Media and Global Trade Developments - China's Foreign Minister announced willingness to negotiate a free trade agreement with the European Union, emphasizing cooperation over rivalry [9] - The New York Times Company demonstrated strength in digital transformation, contributing to its revenue growth [7] Crude Oil Markets Face Headwinds - WTI crude oil prices are trading near $60.59, facing downward pressure from a stronger U.S. dollar and increased U.S. crude inventories [10] - OPEC+ has paused output hikes for Q1 2026, agreeing to a modest increase in December, but market sentiment remains cautiously bearish [10]

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]

Core Insights - Amgen Inc. is recognized as one of the Best Wide Moat Stocks due to its strong intellectual property and brand reputation [1] - The launch of AmgenNow, a direct-to-patient program for Repatha, aims to reduce drug prices significantly, with a monthly price of $239, approximately 60% lower than the current US list price [1] - Amgen announced a $650 million expansion of its US manufacturing network to enhance drug production and integrate advanced technologies [2] - Despite strong sales growth in key drugs, Amgen faced challenges from macroeconomic factors, including potential tariff impacts and drug pricing pressures [3] - The company reaffirmed its commitment to domestic manufacturing with $2 billion expansions planned in Ohio and North Carolina, building on over $5 billion in US operational investments since 2017 [3] - Amgen's pipeline remains robust, with positive results from trials for gastric cancer and a weight-loss drug, MariTide, which shows promise for convenient dosing [3]

Group 1 - Amgen Inc. is recognized as one of the 11 cheap quarterly dividend stocks to buy currently [1] - The company has a strong and diverse portfolio with over two dozen brands, including several blockbuster drugs generating over $1 billion in annual sales [2] - Amgen's medicines cover multiple therapeutic areas, including heart health, bone health, and psoriasis treatment [3] Group 2 - In the second quarter, Amgen reported revenue of $9.2 billion, reflecting a 9% increase from the previous year, while adjusted earnings per share rose 21% to $6.02 [4] - The company has demonstrated consistent dividend growth for 14 consecutive years, currently offering a quarterly dividend of $2.38 per share and a dividend yield of 3.32% as of September 23 [4]

Core Viewpoint - The healthcare sector, particularly dividend-paying stocks like Amgen and Merck, presents solid investment opportunities due to their non-cyclical nature and consistent revenue generation even in challenging economic conditions [1][2]. Group 1: Amgen - Amgen is a leading biotech company with a diverse portfolio of over two dozen products, many of which are blockbuster drugs generating over $1 billion in annual sales [4]. - The company reported a 9% year-over-year revenue growth in Q2, reaching $9.2 billion, with non-GAAP earnings per share at $6.02, a 21% increase from the previous year [6]. - Amgen faces patent cliffs and biosimilar competition but has strong growth drivers, including Tezspire for asthma, which saw a 46% year-over-year sales increase to $342 million [7][8]. - The company has a robust dividend profile with a forward yield of 3.4%, having increased its payouts annually since 2011 [9]. Group 2: Merck - Merck is experiencing increased competition for its cancer drug Keytruda, with patent exclusivity expiring in 2028, and has faced declining sales in its vaccine franchise due to paused shipments in China [10][11]. - In Q2, Merck's revenue declined by 2% year-over-year to $15.8 billion [11]. - The company is developing a subcutaneous version of Keytruda to extend its patent life and has received approval for new products like Winrevair for pulmonary arterial hypertension [12][13]. - Merck's forward yield is currently at 3.9%, with an 88.8% increase in dividends over the past decade, making it an attractive option for dividend investors despite current challenges [15].

Summary of Entera Bio Ltd. Conference Call Company Overview - **Company**: Entera Bio Ltd. - **Industry**: Biopharmaceuticals - **Focus**: Development of first-in-class oral peptide therapies for unmet medical needs - **Ticker Symbol**: ENTX (listed on NASDAQ) - **Cash Runway**: Expected to last until Q3 2026 [2][24] Core Technology and Pipeline - **Technology Platform**: NTAB technology platform enables the development of oral peptide therapies in tablet form, overcoming challenges such as proteolytic degradation and molecular polarity [2][3][4] - **Lead Asset**: EB613, the only oral peptide in development for osteoporosis, is set to enter a phase 3 registrational study [2][4][17] - **Other Pipeline Assets**: Include treatments for hypoparathyroidism, metabolic disorders, obesity, and gastrointestinal inflammation [2][4] EB613 Details - **Mechanism of Action**: EB613 is a PTH(1-34) teriparatide tablet that stimulates bone formation and suppresses bone resorption, aiming to provide a validated mechanism of action in a convenient oral format [6][10][12] - **Clinical Studies**: Phase 2 studies showed favorable outcomes in bone formation markers and bone mineral density (BMD) across skeletal sites [12][13][14] - **Comparison with Forteo**: EB613 has a similar amino acid sequence to Forteo but offers a more rapid onset of action and improved BMD outcomes, particularly at the hip [6][14][15] Osteoporosis Market Insights - **Prevalence**: Approximately 200 million women globally are affected by osteoporosis, with significant fracture risks [7][8] - **Current Treatment Landscape**: Most treatments are antiresorptive drugs, with bisphosphonates being the most commonly prescribed [9][10] - **Patient Access Issues**: Many patients do not receive adequate treatment due to the limitations of injectable therapies and the need for healthcare provider resources [11][19] Phase 3 Study Plans - **Study Design**: A double-blind, placebo-controlled, 24-month study focusing on total hip BMD as the primary endpoint, with secondary endpoints including vertebral fracture trends [17][18] - **Regulatory Alignment**: Recent agreement with the FDA allows the use of total hip BMD as a primary endpoint, a significant milestone for the company [18][23] Market Research and Patient Insights - **Clinician Feedback**: 30% of osteoporosis patients experience suboptimal responses to current treatments, highlighting a need for more effective solutions [19] - **Patient Interest**: 55% of surveyed patients expressed interest in oral bone-building treatments, indicating a potential market for EB613 [19] Future Developments - **Partnership with OPKO Health**: Development of an oral oxyntomodulin tablet is underway, with an IND filing expected in early 2026 [5][20] - **Additional Programs**: Plans to validate a different peptide for hypoparathyroidism and to present supplemental data at upcoming conferences [23] Conclusion - Entera Bio Ltd. is positioned to address significant unmet needs in osteoporosis treatment with its innovative oral peptide therapies, particularly EB613, which aims to enhance patient access and compliance compared to existing injectable options [2][19][24]