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]

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 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]