Group 1: Industry Trends - International drugmakers are increasing investments in the U.S. to be closer to key markets amid tariff pressures affecting global trade and supply chains [1][2] - Although pharmaceutical imports are exempt from U.S. tariffs, there are ongoing threats from the Trump administration to raise tariffs significantly, potentially up to 250% [2] Group 2: Company Investments - Samsung Biologics has signed a nearly $1.3 billion contract manufacturing deal with an undisclosed U.S. pharmaceutical company, which is set to run through December 2029 [3] - Prior to the recent deal, Samsung Biologics secured a $514 million contract with another U.S. drugmaker and a $1.2 billion contract with an Asia-based pharmaceutical company [4] - Amgen plans to invest over $600 million to establish a science and innovation center at its headquarters in Thousand Oaks, California, aimed at accelerating R&D for next-generation medicines [5] - Amgen's recent investments also include a $900 million factory expansion in Central Ohio and a $1 billion manufacturing plant in Holly Springs, North Carolina, with over $40 billion invested in manufacturing and R&D since 2017 [6]

Group 1 - The focus of iREIT+HOYA Capital is on income-producing asset classes that provide sustainable portfolio income, diversification, and inflation hedging [1] - The strategy emphasizes acquiring quality assets at favorable prices, which is a hallmark of successful investors like Warren Buffett [2] - The investment approach is geared towards durable income growth stocks that are considered defensive, with a medium- to long-term investment horizon [2] Group 2 - The article does not provide specific financial advice or recommendations, emphasizing the importance of due diligence by readers [4][5] - There is a disclosure regarding a beneficial long position in AMGN shares, indicating a personal investment interest by the author [3]

Core Viewpoint - The healthcare sector, particularly dividend-paying stocks like Amgen and Merck, presents solid investment opportunities due to their non-cyclical nature and consistent revenue generation even in challenging economic conditions [1][2]. Group 1: Amgen - Amgen is a leading biotech company with a diverse portfolio of over two dozen products, many of which are blockbuster drugs generating over $1 billion in annual sales [4]. - The company reported a 9% year-over-year revenue growth in Q2, reaching $9.2 billion, with non-GAAP earnings per share at $6.02, a 21% increase from the previous year [6]. - Amgen faces patent cliffs and biosimilar competition but has strong growth drivers, including Tezspire for asthma, which saw a 46% year-over-year sales increase to $342 million [7][8]. - The company has a robust dividend profile with a forward yield of 3.4%, having increased its payouts annually since 2011 [9]. Group 2: Merck - Merck is experiencing increased competition for its cancer drug Keytruda, with patent exclusivity expiring in 2028, and has faced declining sales in its vaccine franchise due to paused shipments in China [10][11]. - In Q2, Merck's revenue declined by 2% year-over-year to $15.8 billion [11]. - The company is developing a subcutaneous version of Keytruda to extend its patent life and has received approval for new products like Winrevair for pulmonary arterial hypertension [12][13]. - Merck's forward yield is currently at 3.9%, with an 88.8% increase in dividends over the past decade, making it an attractive option for dividend investors despite current challenges [15].

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... ...

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]