Core Points - Amgen announced a $900 million expansion of its manufacturing facility in Ohio, increasing total investment in Central Ohio to over $1.4 billion and creating 750 jobs [1][2] - The expansion is part of Amgen's commitment to U.S. manufacturing and aims to enhance its global biomanufacturing network [2][4] - Since the Tax Cuts and Jobs Act of 2017, Amgen has invested nearly $5 billion in the U.S., generating an estimated $12 billion in additional economic output [3] Company Overview - Amgen has been a leader in biologic medicine manufacturing since 1988 and emphasizes innovation and access to medicines for patients worldwide [2][5] - The company has a strong pipeline targeting various diseases, including cancer and heart disease, and has received multiple accolades for its innovation and workplace environment [6] Economic Impact - Ohio's supportive business climate and skilled workforce have made it an attractive location for Amgen's investments, contributing to the state's economic development [3] - The expansion in Ohio follows a recent announcement of a $1 billion investment for a second manufacturing plant in Holly Springs, NC, indicating a broader strategy to enhance U.S. manufacturing capabilities [4]

Amgen (AMGN) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on May 1. On the oth ...

Today, Amgen (NASDAQ: AMGN ) is a global biopharmaceutical company with a presence in almost a hundred countries and one of the most extensive product portfolios in the industry. Over the past couple of years, the company has competentlyMy professional background spans multiple continents and includes experience in private banking, corporate finance, and strategic advisory. For several years, I developed and led a private banking department in Dubai, where I crafted tailored investment solutions to meet the ...

Core Insights - Amgen's IMDELLTRA® (tarlatamab-dlle) has shown a substantial survival advantage over standard chemotherapy in patients with small cell lung cancer (SCLC) who have progressed after platinum-based chemotherapy, as demonstrated in the Phase 3 DeLLphi-304 clinical trial [1][2][3] Group 1: Clinical Trial Results - The DeLLphi-304 trial met its primary endpoint, showing statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care chemotherapy [1][3] - IMDELLTRA is indicated for adult patients with extensive-stage SCLC who have disease progression on or after platinum-based chemotherapy, with approval based on overall response rate and duration of response [5][6] Group 2: Drug Mechanism and Target Population - IMDELLTRA is a first-in-class immunotherapy that targets DLL3 on tumor cells and CD3 on T cells, leading to the destruction of DLL3-expressing SCLC cells [4][6] - DLL3 is expressed on approximately 85-96% of SCLC patients, making it a promising target for therapy [4][6] Group 3: Safety and Efficacy - The safety profile of IMDELLTRA was consistent with its known profile, and detailed data from the trial will be presented at an upcoming medical congress [2][3] - Serious adverse reactions occurred in 58% of patients, with cytokine release syndrome (CRS) being the most common [26][27] Group 4: Future Developments - Amgen is advancing a robust development program for tarlatamab, including multiple ongoing clinical trials evaluating its efficacy in various treatment settings for SCLC [8][9]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: Biopharma in North America - **Market Analysis**: The latest weekly Total Prescription (TRx) year-over-year (YoY) growth for the week ending March 28, 2025, was +2.1%, a decrease from +2.5% the previous week and +3.1% over the past 12 weeks [1][2] Core Insights - **TRx Growth**: For the week ended March 28, the US total market weekly TRx YoY change was +2.1%, compared to +0.4% a year ago. The rolling 4-week TRx YoY was +2.9%, and the rolling 12-week TRx YoY was +3.1% [2] - **Extended Unit Growth**: Extended unit (EUTRx) weekly YoY growth was +0.7%, which is below the TRx YoY growth [2] - **Sequential Growth**: Sequential weekly TRx growth was -1.8%, compared to -1.5% the week before [2] Company-Specific Developments - **Bristol Myers Squibb (BMY)**: - Cobenfy, approved for schizophrenia on September 26, 2024, had approximately 1,570 scripts for the week, up from ~1,440 the previous week. To meet 2025 consensus expectations, Cobenfy TRx needs to track at ~2-3 times the volumes from recent schizophrenia launches [3] - The consensus estimate for Cobenfy has declined to $160 million from $196 million, implying ~125K TRx are required to meet this estimate [3] - **Vertex Pharmaceuticals (VRTX)**: - Journavx, approved for acute pain on January 30, 2025, recorded approximately 2,230 scripts for the week, up from ~1,760 the previous week. To achieve the 2025 sales estimate of $87 million, approximately 229K and 441K total scripts are needed for 14-day and 7-day script durations, respectively [4] Competitive Landscape - **Biosimilars**: The TRx share chart for Stelara biosimilars was added, with Amgen's Wezlana launched on January 17, 2025, and Teva/Alvotech's Selarsdi launched on February 21, 2025 [5] - **Launch Comparisons**: A comparison chart for Descovy vs. Apretude was added, with anticipation for FDA approval of GILD's Lenacapavir [8] Seasonal Trends - **Vaccine Tracking**: Seasonal respiratory vaccine tracking exhibits were added, noting that RSV vaccine volumes are tracking ~65% below last year's levels, and COVID vaccine volumes are also down year-over-year [9] Notable Drug Performance - **Key Products**: - Mounjaro and Zepbound from Eli Lilly are being tracked, with Mounjaro showing significant growth [10] - The oral psoriasis market is being monitored, particularly BMY's Sotyktu launch against AMGN's Otezla [10] Pricing and Market Dynamics - **Immunology Pricing Analysis**: Updated charts for 4Q24 show how volume from additional indications impacts price per script for various drugs [11] - **Biosimilar Adoption**: Comprehensive analysis of biosimilar adoption across various branded drugs was presented [12] Additional Insights - **Market Trends**: The IQVIA databases differentiate between prescription and sales trends, with TRx representing total prescriptions dispensed, including refills [27] - **Sales Dynamics**: The report emphasizes that IQVIA sales dollars reflect list prices and do not account for rebates or discounts, indicating a need for careful interpretation of sales data [43] This summary encapsulates the key points from the conference call, highlighting industry trends, company-specific developments, and competitive dynamics within the biopharma sector.

Group 1: AbbVie - AbbVie's share price has increased by a double-digit percentage in 2025, indicating strong demand for its products regardless of economic conditions [2] - The company has effectively managed the patent expiration of its top-selling drug, Humira, with successors Rinvoq and Skyrizi expected to generate more sales combined than Humira at its peak [3] - AbbVie has made significant acquisitions, adding growth drivers like Elahere, Botox, and Vraylar, and has over 90 programs in clinical development, including promising late-stage candidates [4] - AbbVie boasts a forward dividend yield of 3.25% and has a history of 53 consecutive years of dividend increases, qualifying it as a Dividend King [5] Group 2: Amgen - Amgen has faced challenges in organic revenue growth and a clinical setback with its weight management drug, MariTide, but its long-term prospects remain strong [6] - The company has strengthened its lineup through acquisitions, with growth drivers like Tepezza and Tezspire, and has over 30 candidates in phase 3 studies to ensure steady revenue and earnings growth [7][8] - Amgen has consistently raised its dividends, with a 201% increase over the past decade, and a forward yield of 3.1%, surpassing the S&P 500 average of 1.3% [8][9] Group 3: Eli Lilly - Eli Lilly's current dividend yield is less than 1%, but the company has significantly increased its dividend over the years, currently paying $1.50 per quarter, more than double the amount from five years ago [10][11] - The stock has appreciated by 480% over the past five years, with total returns including dividends reaching approximately 533%, compared to the S&P 500's 135% [12] - Eli Lilly is recognized for its growth potential with assets like Zepbound and Mounjaro, and despite a high valuation, it is considered a strong long-term investment due to its fast-growing business and robust dividend growth [13]

Core Viewpoint - The healthcare sector is often avoided by investors due to a lack of reliable dividend payers, but notable exceptions exist in companies like Amgen and AbbVie, which have attractive dividend policies [1][2]. Group 1: Amgen - Amgen is recognized for its strong performance in the obesity drug market and has a robust lineup of blockbuster drugs and a promising pipeline [3]. - In the previous year, Amgen's overall revenue increased by 19% to over $33.4 billion, with net income at nearly $4.1 billion, despite higher costs in research and development [5]. - Amgen raised its quarterly dividend by 6% to $2.38 per share, resulting in a yield of approximately 3%, which is nearly double the average yield of S&P 500 companies [6]. Group 2: AbbVie - AbbVie emphasizes its quarterly dividend, currently yielding over 3%, and has a history of regular dividend increases, with a recent 6% hike to $1.64 per share [8]. - Over the past decade, AbbVie has more than tripled its per-share payout, demonstrating a strong commitment to returning value to shareholders [9]. - AbbVie reported a nearly 4% increase in total net revenue to $56.3 billion, with net income slightly down to just under $4.3 billion due to rising costs [11]. - The company is well-positioned for future growth, with a projected compound annual growth rate (CAGR) in revenue in the high single-digit percentages through 2029, and an increased sales forecast for its drugs Rinvoq and Skyrizi to $31 billion by 2027 [12].

Core Viewpoint - Amgen's drug Uplizna has received FDA approval for a new indication to treat immunoglobulin G4-related disease (IgG4-RD), marking it as the first and only FDA-approved treatment for this condition [1][2]. Group 1: Drug Approval and Market Impact - Uplizna is now approved for treating adults with IgG4-RD, a chronic disease with significant unmet medical needs [2]. - The approval is based on the phase III MITIGATE study, which demonstrated an 87% reduction in the risk of flares compared to placebo [3][4]. - Year to date, Amgen's shares have increased by 18.9%, outperforming the industry average rise of 1.2% [2]. Group 2: Clinical Study Insights - The MITIGATE study's primary endpoint was to assess the time to first flare in patients with IgG4-RD [3]. - In the study, 58.8% of Uplizna-treated participants achieved flare-free, corticosteroid-free, and complete remission at week 52, compared to 22.4% in the placebo group [4]. Group 3: Future Developments - Amgen is also exploring Uplizna for generalized myasthenia gravis (gMG) and plans to submit a regulatory filing for this indication by the first half of 2025 [5][6]. - Uplizna generated sales of $379 million in 2024, and further label expansions are expected to drive sales growth in future quarters [6].

Core Viewpoint - The Trump administration's recent tariffs have significantly impacted the stock market, with pharmaceuticals and biotech being relatively less affected compared to other sectors [1][2]. Industry Impact - The stock market experienced one of its worst trading days, with the S&P 500 dropping by 4.8%, while Catalyst Pharmaceuticals and Veeva Systems saw smaller declines of 1.5% and 2%, respectively. Notably, Amgen and AstraZeneca reported gains of 1.5% and 2.4% [2]. - The pharmaceutical sector was notably absent from the list of tariffs, which had initially included a proposed 25% duty on foreign pharmaceutical manufacturers [3][4]. Future Considerations - The exemption from tariffs is temporary, and there are indications that the administration may soon impose tariffs specifically targeting pharmaceutical exports [4][5]. - The pharmaceutical industry has powerful lobbyists advocating for reduced tariffs, which may have influenced the temporary exemption [5][6]. Regulatory Developments - Despite the looming threat of tariffs, the pharmaceutical industry continues to announce positive developments, such as Amgen's FDA approval for its Uplizna drug to treat IgG4-related disease, marking a significant advancement for patients [9][10]. - The approval of Uplizna is expected to reduce reliance on long-term steroid use for patients, highlighting the industry's ongoing commitment to regulatory approvals and medication development [10].

Core Insights - Amgen's UPLIZNA has received FDA approval as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet medical need in this chronic and debilitating condition [1][2][8] Company Developments - The approval of UPLIZNA is a pivotal moment for patients and healthcare providers, offering a proven treatment that targets a key driver of IgG4-RD, thereby reducing the risk of flares and reliance on long-term steroid use [2][3] - UPLIZNA's efficacy is supported by data from the MITIGATE trial, which demonstrated an 87% reduction in the risk of IgG4-RD flares compared to placebo [9] - UPLIZNA is also indicated for the treatment of AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) and has received Orphan Drug Designation for generalized myasthenia gravis (gMG), with regulatory filings for gMG expected to be completed in H1 2025 [1][8] Clinical Trial Insights - The MITIGATE trial was the first randomized, double-blind, placebo-controlled trial for IgG4-RD, showing significant reductions in disease activity and flares among patients treated with UPLIZNA [4][5] - Key findings from the trial include that 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, and complete remission at Week 52, compared to 22.4% in the placebo group [9] - UPLIZNA-treated patients experienced a ten-fold reduction in mean total glucocorticoid use for disease control compared to those on placebo [9] Disease Background - IgG4-RD is a chronic, systemic, immune-mediated disease that can affect multiple organs and lead to fibrosis and permanent organ damage [6] - The disease is characterized by unpredictable inflammatory flares and can mimic other conditions, complicating timely diagnosis [6][7] - The prevalence of IgG4-RD is estimated at 20,000 people in the U.S., with a higher incidence in men and typical onset between ages 50 and 70 [6]