Core Insights - Amgen announced new data from the Phase 3 MINT trial showing the efficacy and safety of UPLIZNA in adults with generalized myasthenia gravis (gMG), indicating durable symptom relief with a simplified treatment regimen of two doses per year after an initial loading dose [1][3] Group 1: Trial Results - The MINT trial demonstrated significant improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared to placebo, with an adjusted difference of -2.8 (95% CI, -3.9 to -1.7) in the AChR+ subpopulation at week 52 [2] - Among AChR+ patients treated with UPLIZNA, 72.3% experienced a ≥3 point improvement in the MG-ADL score, compared to 45.2% in the placebo group [2] - The trial also showed a greater change from baseline in the Quantitative Myasthenia Gravis (QMG) score for UPLIZNA patients at week 52, with an adjusted difference of -4.3 (95% CI, -5.9 to -2.8) [3] Group 2: Treatment Protocol - The MINT trial was notable for incorporating a corticosteroid tapering protocol, where patients on corticosteroids were reduced to prednisone 5 mg per day by week 24 [3][10] - UPLIZNA is administered as an initial loading dose followed by maintenance doses every six months, which simplifies the treatment regimen for patients [12] Group 3: Regulatory Status - UPLIZNA is currently approved for treating adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) and is under priority FDA review for Immunoglobulin G4-related disease (IgG4-RD) with a PDUFA date of April 3, 2025 [5] - The FDA has granted UPLIZNA Orphan Drug Designation for the treatment of gMG, with regulatory filing activities expected to be completed in the first half of 2025 [5] Group 4: Safety Profile - No new safety signals were identified during the MINT trial, and the overall treatment-emergent adverse event (TEAE) profile was consistent with the known safety profile for UPLIZNA [4] - The most common adverse events reported included infusion-related reactions, nasopharyngitis, and urinary tract infections [4][15]

Core Insights - The article provides an overview of the investment landscape, emphasizing the importance of independent research and verification of information before making investment decisions [2][3]. Group 1 - The content is not intended as exhaustive analysis of any featured company, highlighting the need for readers to conduct their own research [2]. - The predictions and opinions presented are based on a probabilistic approach, indicating that they do not guarantee absolute certainty [2]. - The article stresses that past performance is not indicative of future results, underscoring the inherent volatility and risks associated with stock investments [3].

Economic Overview - The three major U.S. indexes, S&P 500, Dow Jones Industrial Average, and Nasdaq Composite, experienced declines of 1.36%, 0.90%, and 0.84% respectively last week, influenced by policy shifts and trade tariffs under the Trump administration [1] - Personal consumption expenditure (PCE) rose by 0.3% in January, exceeding the Federal Reserve's 2% inflation target, with an annual rate of 2.5% [2] - Personal income increased by 0.9%, while personal spending unexpectedly declined by 0.2% in January, indicating consumer concerns about future economic conditions [2] - The U.S. economy added 151,000 jobs in February, with the unemployment rate rising to 4.1% from 4% the previous month, highlighting underlying economic weaknesses [3] Stock Performance - NioCorp Developments Ltd. (NB) shares increased by 38.5% since being upgraded to Zacks Rank 2 (Buy) on January 14, outperforming the S&P 500's 1% decrease [4] - TXO Partners, L.P. (TXO) saw a return of 9.8% since its upgrade to Zacks Rank 1 (Strong Buy) on January 14 [5] - The Zacks Model Portfolio, consisting of Zacks Rank 1 stocks, has outperformed the S&P 500 index by almost 13 percentage points since 1988, with an annualized average return of +23.9% compared to +11.3% for the S&P 500 [7] Focus List and Portfolios - Sea Limited (SE) gained 16.7% and Uber Technologies, Inc. (UBER) returned 15.4% over the past 12 weeks, both part of the Zacks Focus List, while the S&P 500 decreased by 5.3% during the same period [11] - The Zacks Focus List portfolio returned +18.41% in 2024, compared to +25.04% for the S&P 500 [12] - The Earnings Certain Admiral Portfolio (ECAP) includes Amgen Inc. (AZO) and Intercontinental Exchange, Inc. (ICE), which returned 19.2% and 9.2% respectively over the past 12 weeks [14] Dividend Portfolio Performance - The Earnings Certain Dividend Portfolio (ECDP) includes Coca-Cola Company (KO) and Johnson & Johnson (JNJ), which returned 14.2% and 11.6% respectively over the past 12 weeks [17] - The ECDP returned +6.95% in 2024, compared to +24.89% for the S&P 500 [18]

Investment Rating - The investment rating for the pharmaceutical industry is "Outperform the Market" (maintained) [1] Core Insights - The main growth driver remains the launch of innovative products, particularly in the GLP-1 category, with significant revenue increases reported by companies like Eli Lilly and Novo Nordisk [3] - The report highlights the strong performance of key products across various therapeutic areas, including oncology, metabolism, and immunology, with notable sales growth percentages [3] Summary by Sections 01 Overview of Overseas Pharmaceutical Companies Q4 2024 and Annual Performance - Eli Lilly's revenue increased by 32% in 2024, driven by GLP-1 products [3] - Novo Nordisk's sales reached approximately $40.5 billion, a 25% increase, with significant contributions from GLP-1 products [29] - AstraZeneca and Merck also reported strong growth, with revenue increases of 21% and 10% respectively [3] 02 Performance Review of Overseas Pharmaceutical Companies - Eli Lilly's Q4 sales reached $13.5 billion, a 45% increase, with GLP-1 products contributing significantly [18] - Novo Nordisk's GLP-1 products achieved sales of approximately $22.5 billion, with a 20% increase in the diabetes segment [29] - JNJ's pharmaceutical segment reported $14.3 billion in Q4, with oncology products driving growth [40] R&D Investment - The top 15 pharmaceutical companies invested over $150 billion in R&D in 2024, a 7% increase year-on-year, with a research expense ratio of 21.8% [8] Sales Performance in China - Seven overseas pharmaceutical companies reported combined sales of approximately 515 billion RMB in Q4 2024, with a year-on-year growth of 10% [14]

Core Insights - Amgen reported strong Q4 2024 earnings, with adjusted earnings of $5.31 per share, surpassing estimates, and total revenues of $9.1 billion, also exceeding expectations [2][21] - The company anticipates continued revenue growth in 2025, driven by key products, despite challenges from price erosion [22][23] Financial Performance - Q4 2024 adjusted earnings rose 13% year over year, while total revenues increased by 11% [2] - Total product revenues reached $8.72 billion, with a 14% increase in volume, although offset by price declines [3][4] - Full-year 2024 sales rose 19% to $33.4 billion, slightly beating estimates [21] Product Performance - Ten products achieved double-digit volume growth, with notable contributions from rare disease drugs, generating $1.2 billion in sales [4] - Key drugs like Repatha and Evenity saw significant sales increases, with Repatha up 45% year over year [6][5] - Established products experienced a 29% decline in sales, totaling $500 million [18] Cost and Margin Analysis - Adjusted operating margin declined to 46.3%, with operating expenses rising 11% to $5.05 billion [20] - R&D expenses increased by 14% year over year, reflecting higher spending on clinical programs [20] Future Guidance - For 2025, Amgen expects total revenues between $34.3 billion and $35.7 billion, with adjusted earnings projected between $20.00 and $21.20 per share [22][23] - The company anticipates a decline in operating margin to around 46% due to increased R&D costs [23] Pipeline Developments - Amgen plans to initiate a broad phase III program on MariTide targeting obesity and related conditions in 2025 [25]

Core Points - Amgen's Board of Directors declared a dividend of $2.38 per share for Q2 2025, payable on June 6, 2025, to stockholders of record as of May 16, 2025 [1] Company Overview - Amgen is a biotechnology company that discovers, develops, manufactures, and delivers innovative medicines for various diseases, leveraging over 40 years of industry experience [2] - The company has a broad pipeline aimed at treating cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [2] Recognition and Market Position - In 2024, Amgen was recognized as one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes [3] - Amgen is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, highlighting its status as one of the largest and most innovative non-financial companies [3]

Core Insights - The Phase 3 WAYPOINT trial results demonstrate that TEZSPIRE (tezepelumab-ekko) significantly reduces nasal polyp severity, the need for surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo [1][2][17] Efficacy Results - TEZSPIRE treatment resulted in a reduction of the Nasal Polyp Score (NPS) by -2.065 and nasal congestion by -1.028 at week 52 compared to placebo, with both results being statistically significant (p<0.0001) [1][2] - Improvements in NPS were observed as early as week four and in nasal congestion as early as week two, with effects sustained through week 52 [1][2] - The need for nasal polyp surgery was reduced by 98% and the need for systemic corticosteroid treatment was reduced by 88% compared to placebo, both statistically significant (p<0.0001) [1][2] Secondary Outcomes - Statistically significant improvements were noted across all key secondary outcomes, including loss of smell, quality of life (measured by SNOT-22), and sinus CT scores [2][17] - The time to first nasal polyp surgery decision and systemic glucocorticoid use was significantly longer in the TEZSPIRE group compared to placebo [2][17] Safety Profile - TEZSPIRE exhibited a safety profile consistent with its approved indication for severe asthma, with the most frequently reported adverse events being COVID-19, nasopharyngitis, and upper respiratory tract infections [3][14] Indications and Future Development - TEZSPIRE is currently indicated for the add-on maintenance treatment of severe asthma and is under review for CRSwNP in multiple regions [3][14] - The drug is also being developed for other potential indications, including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE) [14][18] Collaboration Details - Amgen and AstraZeneca have a collaboration agreement for TEZSPIRE, sharing costs and profits equally, with AstraZeneca leading development and commercialization outside North America [18][19]

Group 1 - The article discusses FerdiS's investment strategy focused on dividend growth stocks and options trading to enhance dividend income [1] - FerdiS manages a portfolio named DivGro, which primarily consists of dividend growth stocks and was established in January 2013 [1] - With over 20 years of investment and trading experience, FerdiS writes about various topics including stock selection and passive income generation [1] Group 2 - The article mentions collaboration with the founders of Portfolio Insight, an online platform dedicated to portfolio management and investment analysis [1] - Dividend Radar is highlighted as a weekly free spreadsheet that lists dividend growth stocks [1]

Financial Performance - Amgen's total product sales for 2024 reached $32.026 billion, a 19.5% increase from $26.910 billion in 2023[36]. - U.S. sales accounted for $23.301 billion, representing 73% of total sales, while the rest of the world (ROW) contributed $8.725 billion, or 27%[36]. - Major wholesalers accounted for 77% of worldwide gross revenues in 2024, with three wholesalers each contributing over 10%[34]. Product Development and Approvals - IMDELLTRA received accelerated FDA approval for extensive-stage small cell lung cancer treatment in May 2024[24]. - TEPEZZA was approved for thyroid eye disease treatment in Japan in September 2024[27]. - MariTide demonstrated up to approximately 20% average weight loss at week 52 in patients without type 2 diabetes, and 17% in those with type 2 diabetes[22]. - BLINCYTO improved disease-free survival (DFS) to 96.0% at three years compared to 87.9% for chemotherapy alone, indicating a 61% reduction in the risk of disease relapse[26]. - UPLIZNA showed an 87% reduction in the risk of IgG4-RD flare compared to placebo during a 52-week trial[28]. - Vectibix is indicated for the treatment of wild-type RAS metastatic colorectal cancer and in combination with LUMAKRAS for KRAS G12C-mutated mCRC in the U.S.[49]. - TEZSPIRE is approved for severe asthma treatment in over 50 countries, including the U.S., Europe, and Japan, representing a significant market opportunity[50]. Research and Development - The company is investing billions annually in R&D to develop new therapies and biosimilars, aiming to provide affordable therapeutic choices[75]. - R&D expenses for the years ended December 31 were $6.0 billion in 2024, $4.8 billion in 2023, and $4.4 billion in 2022, indicating a significant increase in investment in research and development[115]. - As of February 4, 2025, the company has 25 phase 3 programs being studied in investigational indications, up from 24 programs as of January 31, 2024[124]. - The company has major R&D centers located in the United States, Iceland, and the United Kingdom, focusing on human genetics and novel therapeutics[113]. - The company is developing investigational biosimilars, including ABP 206, ABP 234, and ABP 692, which are in phase 3 clinical trials[125]. Competition and Market Challenges - The company faces significant competition from biosimilars and generics, which could impact pricing and market share of its products[56]. - The expiration of patents for key products, such as denosumab and evolocumab, will occur between 2025 and 2031, increasing competitive pressures[59]. - The company anticipates additional biosimilar competition across markets, which may affect both branded and biosimilar product sales[59]. - In the U.S., the company anticipates significant impacts on ENBREL's profitability due to mandatory price setting for Medicare starting in 2026, with the first 10 drugs, including ENBREL, subject to price controls announced in August 2023[70][71]. - The company is experiencing pressures from third-party payers, which are increasingly implementing stricter utilization management criteria and cost containment measures[69]. Manufacturing and Supply Chain - The company is expanding its manufacturing capacity with state-of-the-art biomanufacturing plants, including a facility in North Carolina that is designed to be more flexible and environmentally sustainable[77]. - The biomanufacturing plant in New Albany, Ohio received FDA licensure for commercial production in January 2024, supporting the growing demand for Amgen's medicines[82]. - Amgen employs a risk mitigation strategy for raw materials, including multiple sources or backup inventory to ensure supply continuity[88]. - Manufacturing activities are primarily conducted in Puerto Rico and California, and disruptions at these facilities could significantly impair product supply[199]. - The company relies on third-party suppliers for raw materials and components, which poses risks to product availability[199]. Regulatory and Compliance - The FDA regulates the marketing and promotion of drug products, and non-compliance can lead to significant penalties and adverse publicity[95]. - Amgen continues to monitor adverse events and product complaints post-approval, ensuring compliance with regulatory requirements[106]. - The company is subject to various global privacy and data protection laws, including the EU's GDPR and California's CCPA, which are evolving and may result in significant penalties for non-compliance[110]. Employee and Corporate Culture - As of December 31, 2024, Amgen employed approximately 28,000 staff members globally, with a relatively low turnover rate compared to industry peers[161]. - Amgen's employee compensation programs are designed to be competitive, including cash, equity, and benefits, aimed at attracting and retaining talent[162]. - The company emphasizes a flexible workspace initiative to support employees' preferences for remote or in-person work arrangements[161]. - Amgen's engagement scores in employee surveys were above general market benchmarks in 2024, reflecting positive staff relations[161]. - The company launched an Apprenticeship Program in 2023 to attract and develop talent from nontraditional backgrounds, providing training and mentorship opportunities[172]. Financial Risks and Taxation - The company has faced pricing and reimbursement pressures that have affected profitability, with ongoing legislative changes expected to further impact drug pricing and reimbursement rates[197]. - A significant portion of the company's U.S. business relies on federal government healthcare programs and commercial insurance plans, which are subject to changing reimbursement policies[199]. - The company anticipates additional tax liabilities from provisions of the 2017 Tax Act that will take effect in 2026, which could adversely affect profitability[193]. - The company is contesting proposed adjustments from the IRS regarding profit allocation for the years 2010-2012, which could increase taxable income[216]. - Similar disputes with the IRS for the years 2013-2015 are ongoing, with the company contesting proposed adjustments and penalties[217].

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 focused on 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 Citi's 2025 Virtual Oncology Leadership Summit on February 19, 2025, at 3:00 p.m. ET [1] - Jean-Charles Soria, senior vice president of oncology within global development at Amgen, will be the presenter at the conference [1] - The webcast will be available for media, investors, and the general public, and will be archived for at least 90 days after the event [2]