MariTide is the First Monthly or Less Frequently Dosed Peptide-Antibody Conjugate Being Investigated for the Treatment of Obesity and Type 2 Diabetes THOUSAND OAKS, Calif., June 18, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced full results from Part 1 of the Phase 2 study for MariTide (maridebart cafraglutide, formerly AMG 133) in patients living with obesity, with and without Type 2 diabetes, will be presented along with new data from the Phase 3 FOURIER study of Repatha® (evolocumab) in cardio ...

Amgen Inc. (NASDAQ:AMGN) Goldman Sachs 46th Annual Global Healthcare Conference Call June 10, 2025 9:20 PM ET Company Participants James E. Bradner - Executive Vice President of Research & Development Justin G. Claeys - Vice President of Investor Relations Peter H. Griffith - Executive VP & CFO Conference Call Participants Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division Salveen Jaswal Richter Great. Good morning, everyone. Thank you so much for joining us. I'm really pleased to have wi ...

Financial Data and Key Metrics Changes - First quarter revenues grew by 9% year over year, with non-GAAP EPS increasing by 24% [5] - The revenue from Repatha reached $656 million, up 27% year over year [5] - The rare disease portfolio generated over $1 billion in product sales in the first quarter [7] - The biosimilars portfolio generated $735 million in product sales, up 35% year over year [9][10] - Operating margin is guided to be around 46% for the year, down from 47% last year due to increased R&D opportunities [32] Business Line Data and Key Metrics Changes - General medicine products, including Repatha and Evenity, showed strong growth, with Repatha being a multibillion-dollar product [5][16] - TESPIRE in inflammation grew by 65% year over year [7][19] - The oncology segment, particularly the T cell engager platform, saw a 52% growth in BLINCYTO [8][16] - The rare disease segment continues to show strength with products like Euplisna and KRYSTEXXA [18] Market Data and Key Metrics Changes - Cardiovascular disease remains a leading cause of mortality, driving growth for Repatha [5] - The market for obesity treatments is vast, with estimates suggesting over a billion people affected globally [46] - The company is optimistic about expanding its presence in the rare disease market, particularly with new launches [18][60] Company Strategy and Development Direction - The company's strategy focuses on execution in both the end market portfolio and the advancing pipeline [16][23] - Significant capital allocation is planned for expanding manufacturing capabilities, with $2.3 billion in CapEx for the year [21] - The company is actively engaging in business development opportunities, including collaborations and acquisitions [26][28] Management's Comments on Operating Environment and Future Outlook - Management is closely monitoring the policy and macro environment, including tariffs and drug pricing [10][32] - The company is optimistic about its innovation pipeline and believes it can navigate the current challenges effectively [30][33] - There is a strong focus on patient access and value, with ongoing engagement with policymakers [28][30] Other Important Information - The company is preparing for a PDUFA date for Euplisna in generalized myasthenia gravis [7][60] - Upcoming data presentations at the American Diabetes Association meeting will provide insights into the Meritide program [13][34] Q&A Session Summary Question: What are the key priorities for the company today and what is the forward strategy? - The key strategy is focused on execution in the end market portfolio and rapidly advancing pipeline [16] Question: How important is business development as a lever for the company? - The company maintains an open approach to business development, looking at all opportunities for innovation [26] Question: How is the company engaging with policymakers regarding drug pricing? - The company is actively engaged with policymakers to advocate for innovation and patient access [28] Question: What is the outlook for the obesity market and how will Meritide be positioned? - The obesity market is large and underpenetrated, with Meritide expected to compete effectively across various settings [46][48] Question: What are the commercial opportunities for the recently launched drugs? - The company sees significant potential in IgG4 mediated diseases and myasthenia gravis, with strong efficacy profiles [60][61]

Summary of NewAmsterdam Pharma Company (NAMS) FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Focus**: Development of LDL lowering therapies, specifically elbocetropib Market Opportunity - The LDL lowering market has evolved significantly over the past 15 years, with guidelines shifting to recommend lower LDL targets for high-risk patients, specifically a target of 55 mg/dL [2][5] - The market for LDL lowering drugs is growing, with branded drugs like Repatha increasing by 40% and generic Ezetimibe by 20% [5] - Elbocetropib is positioned to lower LDL by 35% to 50%, making it a competitive option in the market [17] Product Differentiation - Elbocetropib is an LDL plus drug, offering additional benefits beyond LDL lowering, such as potential diabetes protection and Alzheimer's disease implications [6][14] - The drug is well tolerated, with adverse events comparable to placebo, making it appealing for primary care prescriptions [17] - Elbocetropib targets a patient population that does not qualify for injectable therapies, addressing a significant unmet need [18][19] Clinical Trials and FDA Interaction - NAMS has conducted three phase three trials (Brooklyn, Broadway, and Tandem) demonstrating significant LDL lowering efficacy [25][26] - The FDA has requested a dedicated blood pressure trial and an outcome study during the review period, which is expected to read out by the end of 2026 [27][28] - The Broadway trial showed a 21% MACE benefit, indicating potential cardiovascular advantages [29] Financial Position - NAMS has over $800 million in cash, providing a strong financial position for upcoming launches and trials [39][40] - The company is preparing for a structured commercial rollout, with a focus on timing regulatory filings and launch strategies [42] Partnerships and Market Strategy - NAMS has a partnership with Metarini in Europe, which provided significant upfront payments to support the company’s financial needs [43][44] - The company is exploring options for a potential partnership in the U.S. but is currently focused on a go-alone strategy to maximize shareholder value [46] Regulatory Environment - The company is monitoring drug pricing policy dynamics, particularly in relation to its European partner, which may provide some advantages regarding pricing control [49][50] Upcoming Catalysts - Key upcoming events include an R&D Day where further data on MACE benefits and atherosclerosis will be presented, as well as a presentation at the AIC meeting on July 30 [51][53] - The company plans to file for approval in Europe in the second half of the year and is working on a study combining elbocetropib with PCSK9 inhibitors [57] Conclusion - NewAmsterdam Pharma is positioned to capitalize on the growing LDL lowering market with its innovative product, elbocetropib, which offers unique benefits and a strong clinical profile. The company is well-financed and strategically planning for future growth and regulatory approvals.

Summary of NewAmsterdam Pharma Company (NAMS) Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: Jefferies Healthcare Conference - **Date**: June 04, 2025 Key Points Industry and Market Context - The focus is on redefining the treatment of Atherosclerotic Cardiovascular Disease (ASCVD) beyond just LDL reduction to include other risk factors such as LpLA and diabetes [3][6][24] - There are approximately **70 million patients in the U.S.** with elevated LDL under treatment, indicating a vast market opportunity for NAMS's drug, obisetropib [10] Drug Development and Clinical Trials - NAMS has had **three positive Phase III trial readouts** last year, boosting confidence in regulatory approval and market entry [3] - The company is targeting additional conferences to present data that differentiates obisetropib from existing and developing drugs [4] - Obisetropib has shown an **average of 45% reduction in LpLA** in Phase III studies, addressing a significant patient population that does not qualify for existing LpLA-targeted therapies [13] Competitive Advantages - Obisetropib aims to address multiple cardiometabolic risk factors, including LDL, LpLA, and diabetes, making it a comprehensive treatment option [6][29] - The drug is positioned to potentially outperform existing therapies by significantly reducing small LDL particles, which are not effectively targeted by current treatments [37][38] Regulatory and Commercial Strategy - NAMS plans to engage with regulatory agencies to include LpLA in clinical trial sections, which could enhance the drug's marketability [15][16] - The company has raised approximately **$700 million** in financing, providing a strong balance sheet of about **$810 million** to support clinical trials and a planned U.S. launch around **2027** [52][53][54] Future Outlook - The ASCVD market is expected to evolve towards combination therapies and fixed-dose approaches, with obisetropib positioned as a preferred option due to its comprehensive risk factor management [24][28] - The company anticipates a **21% MACE benefit** based on recent data, which could significantly enhance its competitive position in the market [34][49] Additional Insights - NAMS is conducting a Phase II trial (Vinson study) to evaluate the combination of obisetropib with Amgen's Repatha, focusing on both LDL and LpLA reduction [14][19] - The company emphasizes the importance of safety and convenience in treatment options, aiming to provide a low-dose, once-daily pill for patients [32] Conclusion NewAmsterdam Pharma is strategically positioned to redefine ASCVD treatment with obisetropib, leveraging positive clinical trial results and a robust financial foundation to capture a significant share of the market. The focus on comprehensive risk factor management and engagement with regulatory bodies will be crucial for its future success.

Amgen (AMGN) 2025 Conference Summary Company Overview - **Company**: Amgen (AMGN) - **Event**: Jefferies Healthcare Conference, June 04, 2025 Key Points Financial Performance - First quarter revenues increased by **9%**, with non-GAAP earnings per share up **24%** year over year [6] - **14 products** delivered double-digit growth, indicating broad-based strength in the portfolio [6] Product Highlights - **Repatha** and **Evenity** generated over **$1 billion** in revenue in Q1, up **28%** year over year [7] - Significant market opportunity exists with **100 million** patients needing LDL cholesterol lowering and **90%** of very high-risk patients for postmenopausal osteoporosis not receiving appropriate therapy [7] - **Opasiran** is fully enrolled in its phase three cardiovascular outcomes trial [10] - **Euplisna** launched as the first FDA-approved therapy for IgG4-related disease, with a PDUFA date set for December 14 [10] - **TESPIRE** continues to grow in severe uncontrolled asthma, with a PDUFA date for chronic rhinosinusitis with nasal polyps on October 19 [11] - **Biosimilars** generated **$735 million** in revenue in Q1, up **35%** year over year [14] Pipeline and R&D - The company is focused on advancing its pipeline across various therapeutic areas, including general medicine, rare diseases, inflammation, and oncology [5][10] - Upcoming data presentations at the ADA meeting will include results from the **Meritide** phase II trial [7][49] Market Dynamics - The company is aware of the competitive landscape, particularly regarding the launch of biosimilars for **denosumab** [17][26] - Despite concerns about biosimilars, Amgen expects to maintain growth through strong performance of existing products [17][46] Strategic Focus - Amgen emphasizes the importance of innovation and is actively engaging with policymakers to improve patient access while supporting sustainable R&D [15][16] - The company is committed to maintaining a disciplined capital allocation strategy, focusing on innovation, business investment, and returning capital to shareholders [44] Competitive Positioning - Amgen believes its diverse portfolio of growth drivers mitigates risks associated with biosimilars [21] - The company is confident in the competitive differentiation of its products, particularly **Meritide**, which is positioned as a unique offering in the weight management market [49][50] Future Outlook - The company anticipates continued strong growth in branded products, with manageable impacts from biosimilars [46] - Amgen is preparing for significant data releases and product launches in the coming months, which are expected to bolster its market position [88][92] Additional Insights - The company is leveraging technology and AI to enhance operational efficiency and R&D processes [45] - Amgen's focus on patient-friendly delivery systems for its products is expected to improve patient adherence and experience [63][80] This summary encapsulates the key insights and strategic directions discussed during the Amgen conference, highlighting the company's robust financial performance, innovative pipeline, and competitive positioning in the biotechnology sector.

Market Overview - The stock market is experiencing volatility, with the S&P 500 index falling nearly 20% from February highs but recovering fully by May 22 [1] - Investors are concerned about high tariffs, a proposed major tax bill, and the potential for recession or rising inflation [1] Amgen - Amgen is a pharmaceutical company known for its diverse range of drugs, including Enbrel, Prolia, XGEVA, Otezla, and Repatha [3] - The company is developing a weight-loss drug, MariTide, and has initiated two phase 3 trials [4] - In Q1, Amgen reported adjusted earnings of $4.90 per share, surpassing Wall Street estimates of $4.26, with revenue growth of 9% year over year [6] - Amgen has consistently paid dividends since 2011, increasing them for 14 consecutive years, with a current dividend yield of approximately 3.5% [7] - Management expects free cash flow to rebound to $7.4 billion in 2023, covering the expected $5.2 billion in dividend payments [7] Sirius XM - Sirius XM is a leading digital audio company in the U.S., operating Sirius satellite radio and Pandora, reaching 160 million listeners monthly [8] - The company has faced significant challenges, with stock down about 57% over the last five years due to rising competition and declining subscribers [8] - Management is investing in technology, expanding its podcast network, and streamlining subscription offerings, aiming for a 25% increase in subscribers to 50 million and a 50% increase in free cash flow to $1.8 billion [9] - In Q1, Sirius XM's revenue fell 4.3% year over year, and total U.S. subscribers declined by 2% [10] - The company offers a 4.9% dividend yield, having regularly paid and increased its annual dividend since 2017, with a trailing free cash flow yield close to 10% [11]

Summary of Amgen's Conference Call Company Overview - **Company**: Amgen - **Event**: RBC Global Healthcare Conference 2025 - **Key Speakers**: Justin Klaas (Head of Investor Relations), Kaveh Nixafed (Senior VP of Global Market and Access) Financial Performance - **Q1 2025 Revenue Growth**: Revenues increased by 9% year-over-year - **Non-GAAP Earnings Per Share**: Increased by 24% year-over-year - **Product Performance**: 14 products delivered double-digit growth across various therapeutic areas [3][4] Product Highlights - **General Medicine**: - Repatha and Avenity generated over $1 billion in Q1, up 28% year-over-year [5] - Significant potential for treating cardiovascular disease and osteoporosis [5] - **Obesity Treatment**: - Meridide is advancing with two Phase III studies in chronic weight management [6] - **Rare Disease**: - Oplisnow launched as the first FDA-approved therapy for IgG4 related disease, with a PDUFA date set for December 14 for generalized myasthenia gravis [6] - **Oncology**: - Progress in bispecific T cell engager platform with products like BLINCYTO and BELTRA [7] - **Biosimilars**: - Generated $735 million in Q1, up 35% year-over-year, with new launches like HavBlue and Weslana [7] Strategic Focus - **Innovation**: Emphasis on innovation as a top priority, with significant investments in R&D and capital expenditures [11][12] - **Market Access**: - Nearly 50% of commercial plans have Repatha on formulary without prior authorization, leading to a 42% volume growth year-over-year in the U.S. [18] - **Manufacturing**: - Global manufacturing footprint with substantial operations in the U.S., including facilities in Ohio, North Carolina, and Puerto Rico [16] Market Environment - **Macro and Policy Environment**: - Ongoing monitoring of tariffs, taxes, and pricing policies [4][11] - Engagement with policymakers to reinforce the value of U.S.-based innovation [11] Future Outlook - **Obesity Market**: - Anticipation of market fragmentation into subcategories, with a focus on differentiation for Meridide [26] - **Biosimilars Growth**: - Plans to expand the biosimilars portfolio with additional products and global markets [42][43] - **Capital Allocation**: - Focus on investing in innovation, followed by capital expenditures and returning value to shareholders [47] Additional Insights - **Patient Impact Expansion**: A disciplined framework for evaluating molecules for expansion opportunities based on scientific differentiation and existing clinical data [32] - **Rare Disease Strategy**: Emphasis on economies of scope to effectively serve patients with rare diseases [38] - **Biosimilars Integration**: The biosimilars business is seen as complementary to Amgen's core operations, enhancing overall business efficiency [44] This summary encapsulates the key points discussed during the conference call, highlighting Amgen's financial performance, product pipeline, strategic focus, and future outlook in the biopharmaceutical industry.

Core Viewpoint - Amgen and Bristol Myers Squibb are leading biotechnology companies with diverse portfolios, making it challenging to choose between them based on their fundamentals, growth prospects, challenges, and valuations [1][2]. Amgen (AMGN) - Amgen has a vast global footprint and a diverse portfolio, with growth products like Prolia, Xgeva, Evenity, Vectibix, Nplate, Kyprolis, and Blincyto stabilizing revenue despite declining sales from legacy drugs [3][4]. - Increased pricing pressures and competition from biosimilars are expected to negatively impact sales of Prolia and Xgeva starting in 2025 [4]. - Key drug Repatha is driving growth, and the approval of Tezspire for severe asthma has strengthened Amgen's portfolio [4][5]. - Amgen has promising candidates in its pipeline, including a broad phase III program on MariTide targeting obesity and type-II diabetes, with data readouts expected in the second half of 2025 [5]. - The acquisition of Horizon Therapeutics has expanded Amgen's rare disease business significantly [6]. - The Zacks Consensus Estimate for Amgen's 2025 sales indicates a year-over-year increase of 5.31%, with EPS expected to improve by 4.79% [13]. - Amgen's shares have gained 6.2% this year, trading at 13X forward earnings, indicating a higher valuation compared to BMY [16][17]. Bristol Myers Squibb (BMY) - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition for legacy drugs [7][8]. - Reblozyl has shown strong performance in the U.S. and international markets, expected to contribute significantly in the coming decade [7]. - Opdivo maintains momentum with consistent label expansions, and the recent FDA approval of Cobenfy for schizophrenia broadens BMY's portfolio [9][10]. - Despite newer drugs boosting sales, generic competition for legacy drugs has led to a 20% decline in legacy portfolio revenues in Q1 due to impacts from Revlimid and others [11]. - BMY's strategy of acquiring promising companies has resulted in substantial debt, with long-term debt at $46.1 billion as of March 31, 2025 [12]. - The Zacks Consensus Estimate for BMY's 2025 sales implies a year-over-year decrease of 4.10%, while EPS suggests a significant increase of 499.13% [14]. - BMY's shares have lost 15.5% this year, trading at a lower valuation of 7.10 for forward earnings [16][17]. Comparison and Conclusion - Both companies offer attractive dividend yields, with BMY at 5.30% and AMGN at 3.49% [20]. - AMGN is viewed as a better pick currently due to solid fundamentals and recent positive estimate revisions, despite its higher valuation [23].

Core Viewpoint - A federal court jury found Amgen liable for antitrust violations, awarding Regeneron $135.6 million in compensatory damages and $271.2 million in punitive damages due to Amgen's anticompetitive practices that hindered competition for Praluent [1][3]. Summary by Relevant Sections Antitrust Violations - Amgen was found to have violated multiple laws, including the Clayton Act and Sherman Act, by using cross-therapeutic bundled rebates to favor Repatha over Praluent, thereby preventing fair competition [1][2]. Jury Verdict and Damages - The jury awarded Regeneron a total of $406.8 million, comprising $135.6 million in compensatory damages and $271.2 million in punitive damages aimed at deterring similar future conduct [3]. Company Statements - Regeneron emphasized the importance of fair competition in the biotech industry, stating that anticompetitive tactics undermine patient access to innovative therapies and hinder medical advancements [4]. Product Information - Praluent, developed by Regeneron and Sanofi, is designed to lower LDL cholesterol levels by inhibiting PCSK9, and is approved in 60 countries [6][7]. Technology and Innovation - Regeneron's proprietary VelocImmune technology has been instrumental in developing fully human monoclonal antibodies, contributing to a significant portion of FDA-approved treatments [8][9].