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... ...

Group 1 - The presentation features Terence Flynn, an equity analyst from Morgan Stanley, hosting Amgen with CFO Peter Griffith and SVP of Global Marketing Kave Niksefat present [1] - The session aims to provide insights into Amgen's operations and strategies within the biopharma sector [1][2]

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]

Core Insights - Amgen's stock performance over the past three years shows a $10,000 investment would have grown to $12,661, reflecting an average annual growth rate of 8.2%, which underperforms compared to the S&P 500's 19.7% annual growth [2] Company Performance - In the second quarter, Amgen reported a 9% year-over-year revenue increase, with 15 products achieving double-digit sales growth [5] - The company has a robust pipeline with over 50 drugs in development, some of which are showing promising results [5] Valuation and Dividends - Amgen's forward-looking price-to-earnings (P/E) ratio is 13, slightly below its five-year average of 14, indicating a reasonable valuation [6] - The company offers a dividend yield of 3.35%, with total annual payouts increasing from $5.28 in 2018 to $9.39 per share recently [6]

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.

Core Insights - Amgen will present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, featuring executives Peter Griffith and Kave Niksefat [1] - The webcast of the presentation will be available for media, investors, and the public, and will be archived for at least 90 days [2] Company Overview - Amgen is a leader in biotechnology, focusing on discovering, developing, manufacturing, and delivering innovative medicines for serious diseases [3] - The company has a robust pipeline aimed at treating cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [3] - In 2024, Amgen received accolades such as being named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes [4] - Amgen is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, highlighting its significance in the market [4]

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].

Core Insights - The company is experiencing strong business performance and is well-positioned for future growth driven by four key factors [2][3] - In the second quarter, the company reported a 9% year-over-year revenue growth and a 21% increase in non-GAAP earnings per share [4] Group 1: Business Performance - The company has a broad and deep portfolio across four therapeutic areas, with 12 products achieving double-digit sales growth in the second quarter [2] - The company reported a 13% volume growth in the second quarter, indicating robust demand for its products [4] Group 2: Innovation and Execution - The company emphasizes its commitment to innovation, leveraging technology and AI to enhance its product offerings and drive continuous improvement [3] - A focus on execution excellence is highlighted as a critical component of the company's strategy [3] Group 3: Financial Metrics - The reported 21% year-over-year growth in non-GAAP earnings per share reflects the company's effective capital allocation and operational efficiency [4]