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 Insights - Royalty Pharma plc (NASDAQ:RPRX) is recognized as one of the best performing biotech stocks in 2025, focusing on biopharmaceutical royalties by investing in innovative drug products and partnering with various entities to fund clinical trials and product launches [1] Financial Performance - In Q2 2025, Royalty Pharma reported a 20% increase in Portfolio Receipts to $727 million and an 11% rise in Royalty Receipts, driven by products such as Trelegy, Evrysdi, and Tremfya [2] - The company updated its full-year 2025 guidance for Portfolio Receipts to a range of $3.05–$3.15 billion, indicating projected growth of 9%–12% [2] Strategic Moves - A significant milestone was the acquisition of RP Management, LLC in May 2025, which streamlined operations and integrated the royalty portfolio with the company's intellectual property assets, enhancing efficiency and strategic flexibility [3] - The firm expanded its oncology presence by acquiring a royalty interest in Amgen's Imdelltra for an upfront payment of $885 million, with potential royalties of up to $65 million [4] - Royalty Pharma also entered a $2 billion funding arrangement with Revolution Medicines, which included $1.25 billion for a synthetic royalty on daraxonasib and a secured senior loan of $750 million [4] Investment Commitments - In September 2025, Royalty Pharma committed up to $300 million to Zenas Biopharma's obexelimab program in exchange for royalties, highlighting its dedication to supporting innovative pipeline products [5]

Group 1: Rocatinlimab and Clinical Trials - Kyowa Kirin announced the presentation of Phase 3 ROCKET-SHUTTLE trial results for rocatinlimab at the EADV 2025 Annual Meeting, focusing on its efficacy and safety in treating moderate-to-severe atopic dermatitis [1][3] - The ROCKET program consists of eight global studies aimed at establishing the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis [4] Group 2: Atopic Dermatitis Overview - Moderate-to-severe atopic dermatitis is a chronic inflammatory skin disease characterized by severe itching and pain, with a significant unmet need for effective treatments [2][5] - Atopic dermatitis affects 15-20% of children and up to 10% of adults, with T-cell imbalance being a root cause of the disease [5] Group 3: Rocatinlimab Mechanism and Development - Rocatinlimab is an anti-OX40 monoclonal antibody that targets the OX40 receptor on activated T cells, potentially being the first T-cell rebalancing therapy for atopic dermatitis [6] - The drug is also being investigated for other conditions related to T-cell imbalance, including uncontrolled asthma and prurigo nodularis [7] Group 4: Collaboration and Commercialization - Kyowa Kirin and Amgen entered a collaboration agreement for the joint development and commercialization of rocatinlimab, with Amgen leading the global efforts except in Japan [8]

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]

Summary of Entera Bio Ltd. Conference Call Company Overview - **Company**: Entera Bio Ltd. - **Industry**: Biopharmaceuticals - **Focus**: Development of first-in-class oral peptide therapies for unmet medical needs - **Ticker Symbol**: ENTX (listed on NASDAQ) - **Cash Runway**: Expected to last until Q3 2026 [2][24] Core Technology and Pipeline - **Technology Platform**: NTAB technology platform enables the development of oral peptide therapies in tablet form, overcoming challenges such as proteolytic degradation and molecular polarity [2][3][4] - **Lead Asset**: EB613, the only oral peptide in development for osteoporosis, is set to enter a phase 3 registrational study [2][4][17] - **Other Pipeline Assets**: Include treatments for hypoparathyroidism, metabolic disorders, obesity, and gastrointestinal inflammation [2][4] EB613 Details - **Mechanism of Action**: EB613 is a PTH(1-34) teriparatide tablet that stimulates bone formation and suppresses bone resorption, aiming to provide a validated mechanism of action in a convenient oral format [6][10][12] - **Clinical Studies**: Phase 2 studies showed favorable outcomes in bone formation markers and bone mineral density (BMD) across skeletal sites [12][13][14] - **Comparison with Forteo**: EB613 has a similar amino acid sequence to Forteo but offers a more rapid onset of action and improved BMD outcomes, particularly at the hip [6][14][15] Osteoporosis Market Insights - **Prevalence**: Approximately 200 million women globally are affected by osteoporosis, with significant fracture risks [7][8] - **Current Treatment Landscape**: Most treatments are antiresorptive drugs, with bisphosphonates being the most commonly prescribed [9][10] - **Patient Access Issues**: Many patients do not receive adequate treatment due to the limitations of injectable therapies and the need for healthcare provider resources [11][19] Phase 3 Study Plans - **Study Design**: A double-blind, placebo-controlled, 24-month study focusing on total hip BMD as the primary endpoint, with secondary endpoints including vertebral fracture trends [17][18] - **Regulatory Alignment**: Recent agreement with the FDA allows the use of total hip BMD as a primary endpoint, a significant milestone for the company [18][23] Market Research and Patient Insights - **Clinician Feedback**: 30% of osteoporosis patients experience suboptimal responses to current treatments, highlighting a need for more effective solutions [19] - **Patient Interest**: 55% of surveyed patients expressed interest in oral bone-building treatments, indicating a potential market for EB613 [19] Future Developments - **Partnership with OPKO Health**: Development of an oral oxyntomodulin tablet is underway, with an IND filing expected in early 2026 [5][20] - **Additional Programs**: Plans to validate a different peptide for hypoparathyroidism and to present supplemental data at upcoming conferences [23] Conclusion - Entera Bio Ltd. is positioned to address significant unmet needs in osteoporosis treatment with its innovative oral peptide therapies, particularly EB613, which aims to enhance patient access and compliance compared to existing injectable options [2][19][24]