Core Viewpoint - The U.S. government, led by President Trump, is pressuring major pharmaceutical companies to lower drug prices in the U.S. by adhering to the "most-favored-nation" (MFN) pricing policy, which aims to align U.S. drug prices with the lowest prices in other developed countries [1][2][3] Group 1: Government Actions - President Trump has set a deadline of September 29 for pharmaceutical companies to comply with the MFN policy [2] - Multiple federal departments are being mobilized to support this initiative, indicating a coordinated effort to enforce the price reductions [2][3] Group 2: Pharmaceutical Companies Involved - Major pharmaceutical companies receiving Trump's letter include Eli Lilly (LLY.US), Pfizer (PFE.US), Merck (MRK.US), Gilead (GILD.US), Bristol-Myers Squibb (BMY.US), Johnson & Johnson (JNJ.US), Regeneron (REGN.US), Amgen (AMGN.US), AbbVie (ABBV.US), and several European firms such as Merck KGaA, Sanofi (SNY.US), GlaxoSmithKline (GSK.US), AstraZeneca (AZN.US), Novo Nordisk (NVO.US), Roche (RHHBY.US), and Novartis (NVS.US) [1] Group 3: Implications of High Drug Prices - The long-term high drug prices in the U.S. create significant pressure on both public welfare and government finances, making the MFN policy a direct and quantifiable approach to reduce costs [3] - The lack of price regulation in the U.S. compared to other countries contributes to higher drug prices, as U.S. pharmaceutical companies can raise prices without negotiation [3]

The U.S. Food and Drug Administration will send out around 100 cease-and-desist enforcement notices and thousands of letters warning pharmaceutical companies that direct-to-consumer ads must comply wi... ...

PresentationTerence FlynnEquity Analyst Great. Good morning, everybody. I'm Terence Flynn, Morgan Stanley's large-cap U.S. biopharma analyst. Very pleased to be hosting Amgen this morning. Joining us from the company, we have Peter Griffith, the company's CFO; and Kave Niksefat, who is the company's SVP of Global Marketing. Thank you both so much for being here today. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you hav ...

Summary of Amgen's Conference Call Company Overview - **Company**: Amgen - **Industry**: Biopharmaceuticals Key Points and Arguments Financial Performance - Second quarter revenues increased by 9%, with volume up 13% [2] - Non-GAAP EPS rose by 21% year-over-year [2] - Fifteen products achieved double-digit growth in Q2, with fourteen products annualizing at over $1 billion based on Q2 sales [2] Therapeutic Areas and Product Growth - **General Medicine**: - Repatha and Evenity both grew over 30% in Q2 [3] - Over 100 million patients globally need effective LDL cholesterol-lowering treatments, indicating substantial growth potential for Repatha [3] - Evenity has a significant unmet need with over 90% of high-risk postmenopausal women untreated for osteoporosis [3] - Maridebart cafraglutide is advancing in obesity and related conditions with four phase III studies underway [3] - **Rare Disease**: - Generated over $5 billion in Q2 sales [4] - Ultomiris is the leading FDA-approved biologic for NMOSD and is progressing well for generalized myasthenia gravis [4] - Tepezza is the only FDA-approved therapy for thyroid eye disease, with expanding sales efforts [4] - **Inflammation**: - Tezspire grew 46% year-over-year in Q2 and is advancing in additional indications [5] - **Oncology**: - Blincyto grew 45% year-over-year in Q2 [5] - Tarlatamab achieved $134 million in sales, growing 65% quarter-over-quarter [6] Biosimilars Portfolio - Cumulative sales of biosimilars reached $12 billion since 2018, with a 37% year-over-year growth in the first half of the year [9] - The third wave of biosimilars includes products targeting Opdivo, Keytruda, and Ocrevus [9] Capital Allocation and Investments - CapEx guidance for the year is $2.3 billion, focused on U.S. manufacturing and innovation [19] - Over $40 billion invested in manufacturing and R&D since the 2017 Tax Cut and Jobs Act [19] - Major expansions in North Carolina ($1.5 billion) and Ohio ($1.4 billion) are underway [20] Policy and Regulatory Environment - Amgen is actively engaging with the U.S. administration on healthcare reforms, focusing on affordability and innovation [15] - Advocates for 340B reform to benefit patients directly [16] - Discussed the need for rebate reform to ensure discounts benefit patients at the pharmacy counter [16] Pipeline Developments - Rocatinlimab is in the final stages of its development, with ongoing studies to evaluate its competitive position [47] - Maridebart cafraglutide is expected to show promising data in Q4 [51] - Olpasiran targets Lp(a) as a cardiovascular risk factor, with a significant reduction in Lp(a) levels expected [55] Future Outlook - Six growth drivers include Repatha, Evenity, Tezspire, oncology portfolio, rare disease portfolio, and biosimilars [35] - Anticipates some erosion in sales from denosumab products due to biosimilar competition [37] - Focus on maintaining robust margins while investing in innovation [40] Legal Matters - Ongoing Puerto Rico tax litigation is expected to conclude with a decision no earlier than the second half of 2026 [33] Additional Important Information - The company emphasizes the importance of innovation and maintaining a strong pipeline to ensure long-term growth [11] - Amgen's commitment to patient access and affordability aligns with its advocacy for a favorable policy environment [17]

Core Insights - Amgen and Kyowa Kirin announced preliminary top-line results from the ASCEND study, which evaluates rocatinlimab, a T-cell rebalancing therapy targeting the OX40 receptor, for treating moderate to severe atopic dermatitis in adults and adolescents [1][2] Study Overview - The ASCEND study involves approximately 2,600 patients and assesses the long-term safety and efficacy of rocatinlimab administered at doses of 150 mg and 300 mg every four or eight weeks [2] - The study focuses on adults who completed 24 weeks of therapy in previous ROCKET trials and continued for an additional 32 weeks in ASCEND [2] Safety and Efficacy Findings - The primary endpoint of the study is to evaluate the long-term safety of rocatinlimab, with common treatment-emergent adverse events including upper respiratory infections, aphthous ulcers, headache, and influenza [3] - The incidence of gastrointestinal ulceration events with rocatinlimab is reported to be less than 1 per 100 patient-years [4] - Secondary endpoints show that most patients who achieved a clinical response in prior trials reported continued therapeutic benefits after one year of treatment [5] Expert Commentary - Amgen's executive vice president highlighted the importance of understanding OX40 inhibition in managing atopic dermatitis and the long-term safety profile of rocatinlimab [6] - Kyowa Kirin's Chief Medical Officer emphasized the significance of these results in providing new treatment options for patients with moderate to severe atopic dermatitis [6] Future Plans - Amgen and Kyowa Kirin plan to present full results at an upcoming congress or in a peer-reviewed publication [6][7] - The ASCEND study will continue to evaluate the long-term safety and efficacy of rocatinlimab for up to 104 weeks [4][7] About Rocatinlimab - Rocatinlimab is an anti-OX40 monoclonal antibody being investigated for moderate to severe atopic dermatitis and has the potential to be the first T-cell rebalancing therapy targeting the OX40 receptor [10] - The therapy is also being studied for other conditions related to T-cell imbalance, including uncontrolled asthma and prurigo nodularis [10] Company Background - Amgen is a leading biotechnology company focused on innovative medicines for various diseases, including cancer and inflammatory conditions [12] - Kyowa Kirin is a global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation [15]

You could have done worse -- or much better.Quick -- what were you doing back in September of 2022? Were you buying $10,000 of stock in Amgen (AMGN -1.17%)? If so, you might be wondering what that's worth today. Even if you didn't buy Amgen stock then, you might wonder how it has performed -- and if you should buy some shares now.Here's the answer to the question: Over the past three years, a $10,000 investment in Amgen would have become a stake worth ... $12,661. That may seem OK, as your money did grow. A ...

Core Insights - Amgen and Kyowa Kirin announced preliminary top-line results from the ASCEND study, which evaluates rocatinlimab, a T-cell rebalancing therapy targeting the OX40 receptor, for treating moderate to severe atopic dermatitis [1][2] Study Overview - The ASCEND study involves approximately 2,600 patients and assesses the long-term safety and efficacy of rocatinlimab administered at doses of 150 mg and 300 mg every four or eight weeks [2] - The primary endpoint focuses on the long-term safety of rocatinlimab, with a descriptive nature [3] - The study is part of the larger ROCKET Phase 3 clinical program, which includes eight studies aimed at establishing the safety and efficacy profile of rocatinlimab [8][7] Safety and Efficacy Findings - The most common treatment-emergent adverse events in adults included upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis, with a low discontinuation rate due to adverse events [3][4] - The incidence of gastrointestinal ulceration events with rocatinlimab is less than 1 per 100 patient-years [4] - Secondary endpoints showed that patients who achieved a clinical response in previous trials reported continued therapeutic benefits after one year of treatment [5] Expert Commentary - Amgen's executive vice president highlighted the importance of understanding OX40 inhibition in addressing atopic dermatitis and emphasized the durability of rocatinlimab's response and long-term safety profile [6] - Kyowa Kirin's Chief Medical Officer noted that the results represent a significant milestone in understanding rocatinlimab's ongoing therapeutic benefits, with potential maintenance dosing every eight weeks [6] Future Plans - Amgen and Kyowa Kirin plan to present full results at an upcoming congress or in a peer-reviewed publication [6]

Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending **August 29, 2025**, was reported at **+1.7%**, a decrease from **+2.3%** the previous week and **+2.6%** over the past 12 weeks [1][2]. - The **rolling 4-week TRx YoY** change was **+2.3%**, while the **rolling 12-week TRx YoY** was **+2.6%** [2]. - The **Extended Unit (EUTRx)** weekly YoY growth was **+2.0%**, indicating stronger performance compared to the overall TRx YoY [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: The drug **Cobenfy** for schizophrenia was approved on **September 26, 2024**. The current weekly scripts are approximately **2,210**, up from **2,160** the previous week. To meet the 2025 consensus expectations, Cobenfy needs to achieve **~129K TRx** at a net price of **~$1,200** [3]. - **Vertex Pharmaceuticals (VRTX)**: The drug **Journavx** for acute pain was approved on **January 30, 2025**. Current scripts are around **7,280**, with hospital scripts making up about **35%** of total scripts. To achieve projected sales of **$78 million**, approximately **349K total scripts** are needed [4]. - **Gilead Sciences (GILD)**: The drug **Yeztugo** was approved on **June 18, 2025**. The latest total TRx is approximately **470**, up from **390** the previous week. Projections for achieving consensus estimates for the second half of 2025 are discussed, with a focus on gross-to-net pricing adjustments [5]. Market Trends and Comparisons - A comparison of launches between **GILD's Yeztugo**, **Descovy**, and **Apretude** is provided, highlighting the uptake among different patient groups and the anticipated growth trajectory [5][9]. - The **GLP-1 franchise** from **Eli Lilly** shows significant growth, with **Mounjaro** and **Zepbound** experiencing **+66%** and **+233%** YoY growth respectively [20][23]. Additional Insights - The call includes a detailed analysis of **key products** and their respective YoY performance, with notable declines in some established drugs like **Humira** (-39%) and growth in others like **Skyrizi** (+44%) [20]. - The **COVID vaccine** tracking and **biosimilar adoption** analysis are also mentioned, indicating ongoing trends in the pharmaceutical landscape [12][28]. Conclusion - The conference call provides a comprehensive overview of the current state of the biopharma industry in North America, highlighting both challenges and opportunities for key players in the market. The data reflects a mixed performance across various drugs, with some experiencing significant growth while others face declines.

THOUSAND OAKS, Calif., Sept. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 9:15 a.m. ET on September 9, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Kave Niksefat, senior vice president of Global Marketing and Access at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the ...

Core Viewpoint - Sanofi's experimental drug for atopic dermatitis, amlitelimab, has underperformed in late-stage trials, disappointing investors and leading to a pre-market stock drop of up to 9.3% [1]. Group 1: Drug Performance and Market Impact - Amlitelimab showed improvement in skin clearance and disease severity compared to placebo, but the efficacy was still lower than Sanofi's best-selling drug, Dupixent [1]. - The stock has declined by 18% over the past 12 months, reflecting investor concerns about the drug's potential [1]. - Analysts believe the results of the amlitelimab trial are crucial for Sanofi, especially given the uncertain future of another key drug, itepekimab [1]. Group 2: Future Prospects and Comparisons - Sanofi is seeking alternatives to Dupixent, which is projected to generate over €21 billion annually at peak sales [3]. - Amlitelimab is expected to generate approximately €1.5 billion (around $1.75 billion) in annual revenue by 2031 [3]. - Amlitelimab has a dosing advantage, requiring administration only once every three months compared to Dupixent's more frequent dosing schedule [3]. Group 3: Other Drug Developments - The efficacy results of itepekimab have been mixed in recent late-stage trials, as it is being tested for chronic obstructive pulmonary disease in former smokers [4].