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]

Financial Data and Key Metrics Changes - The company reported a 9% year-over-year revenue growth and a 13% volume growth in the second quarter [5] - Non-GAAP earnings per share grew by 21% year-over-year [5] Business Line Data and Key Metrics Changes - In general medicine, Repatha achieved $689 million in sales, growing at 31% year-over-year, while Evenity reached $518 million in sales with a growth of 32% year-over-year [8] - The rare disease segment is now annualizing at over $5 billion, with significant growth from Oplisna and a successful launch in IgG4 related disease [9][10] - The oncology portfolio saw BLINCYTO grow by 45% year-over-year, and IMDELTRA grew at 65% quarter-over-quarter, generating $134 million in sales [13] - The inflammation segment, particularly TestFire, grew by 46% year-over-year in severe uncontrolled asthma [14] Market Data and Key Metrics Changes - The company is expanding its presence in Japan with the successful launch of TEPEZZA and is having ongoing conversations with payers in Europe [70] Company Strategy and Development Direction - The company emphasizes a commitment to innovation, execution excellence, and disciplined capital allocation, with an increased R&D spend guidance of over 20% for the year [15][24] - The focus is on expanding the pipeline, particularly in obesity and cardiometabolic risk management, with multiple Phase III studies ongoing [18][19][48] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ability to serve more patients and address unmet medical needs, highlighting the importance of both inline products and pipeline innovations [72] - The company is well-positioned for long-term growth, with a strong platform and breadth across therapeutic areas [72] Other Important Information - The company has largely completed deleveraging from the Horizon transaction and is on track to return to an efficient capital structure by the end of the year [16] Q&A Session Summary Question: Discussion on Meratide and its safety profile - Management discussed the Phase II study's focus on dose escalation and the pharmacokinetic characteristics of Meratide, which allow for smooth titration to target doses [26][27] Question: Broader program for Meratide - Management highlighted the broad maritime program, including studies in cardiovascular disease and chronic weight management, indicating significant potential in these areas [33][32] Question: Opportunities with Repatha and Vesalius CV trial - Management noted that the Vesalius study will add to the evidence supporting Repatha's use in primary prevention, which is crucial for payer acceptance [42] Question: Positioning of Aplizna in the market - Management emphasized Aplizna's stable efficacy, steroid tapering capability, and attractive dosing schedule as key differentiators in the market [66][67] Question: Progress in geographical expansion post-Horizon deal - Management confirmed successful sales of TEPEZZA in Japan and ongoing discussions with European payers, indicating positive progress in geographical expansion [70]

Financial Data and Key Metrics Changes - The company reported a 9% year-over-year revenue growth and a 21% growth in non-GAAP earnings per share [5][15] - Volume growth was reported at 13% year-over-year [5] Business Line Data and Key Metrics Changes - In general medicine, Repatha achieved $689 million in sales, growing 31% year-over-year, while Evenity reached $518 million, growing 32% year-over-year [6] - Rare disease segment is now annualizing at over $5 billion, with significant growth from Oplisna and TEPEZZA [7][10] - Oncology portfolio saw BLINCYTO grow 45% year-over-year, and IMDELTRA grew 65% quarter-over-quarter, generating $134 million in sales [11] - Inflammation products, particularly TestFire, grew 46% year-over-year in severe uncontrolled asthma [13] Market Data and Key Metrics Changes - The company is expanding its presence in Japan with TEPEZZA and has received approval in Europe, indicating a focus on geographical expansion [71] - The rare disease market is expected to grow, with the company leveraging its manufacturing capabilities to enhance market access [70] Company Strategy and Development Direction - The company emphasizes a commitment to innovation across its therapeutic areas, focusing on execution excellence and disciplined capital allocation [24] - Increased R&D spending guidance to over 20% this year reflects the company's prioritization of innovation [14] - The company is exploring business development opportunities, including acquisitions and partnerships, to expand its portfolio [37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's ability to deliver growth and innovation, citing a strong pipeline and the potential for new product launches [24][74] - The focus remains on addressing unmet medical needs and expanding access to therapies for patients [73] Other Important Information - The company has largely completed deleveraging from the Horizon transaction and aims to return to an efficient capital structure by year-end [15] - The pipeline includes multiple Phase III studies across various therapeutic areas, indicating a robust development strategy [16][19] Q&A Session Summary Question: Discussion on Meratide's safety and dosing - Management discussed the ongoing Phase II study addressing dose escalation and the potential for lower doses to maintain tolerability [26][27] Question: Broader program for Meratide - The company is exploring additional indications for Meratide, including cardiovascular disease and obstructive sleep apnea, based on encouraging Phase II data [33][32] Question: Repatha's opportunity in primary prevention - Management highlighted the Vesalius study's potential to reinforce the value of Repatha in primary care settings [40][41] Question: Olpasiran's positioning in cardiovascular disease - The company believes Olpasiran could achieve significant reductions in Lp(a) levels, differentiating it from competitors [47][50] Question: TESPIRE's potential in COPD - Management expressed confidence in TESPIRE's effectiveness in COPD based on its mechanism of action and previous data in severe asthma [56][58] Question: Bimertuzumab's regulatory filing approach - The decision on regulatory filing will depend on the totality of evidence from ongoing studies [63] Question: Aplizna's market positioning - Aplizna is positioned strongly in the market due to its dosing schedule and efficacy in treating IgG4 related disease and generalized myasthenia gravis [66][68] Question: Progress in geographical expansion post-Horizon deal - The company is successfully launching products in new markets, including Japan, and is optimistic about future growth in rare diseases [71][70]

Core Viewpoint - Amgen plans to invest over $600 million in a new center for science and innovation at its headquarters in Thousand Oaks, California, which is expected to create hundreds of jobs in the U.S. [1][5] Investment and Economic Impact - The new center aims to enhance collaboration among researchers, engineers, and scientists to accelerate the discovery of next-generation therapeutics [2] - Amgen has invested more than $40 billion in manufacturing and R&D in the U.S. since the Tax Cuts and Jobs Act (TCJA) of 2017, including over $5 billion in direct capital expenditures [3] - The enactment of pro-growth tax policies has facilitated Amgen's ability to invest domestically in cutting-edge science and manufacturing [3] Company Commitment and Future Plans - The new center will empower scientists with advanced tools and a collaborative environment to drive scientific excellence [4] - Construction is expected to begin in Q3 2025, further building on Amgen's recent investments, including a $900 million expansion in Central Ohio and a $1 billion investment for a second manufacturing plant in North Carolina [5] Company Background and Recognition - Amgen has been a pioneer in the biotechnology industry for over 40 years, focusing on innovative medicines for serious diseases [6] - The company has received accolades such as being named one of the "World's Most Innovative Companies" and "America's Best Large Employers" [7]