-- Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 -- -- Phase 3 PREVAIL CVOT blinded event rate tracking in line with observed event rate in BROADWAY--         -- Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 -- -- $728.9 million in cash, cash equivalents and marketable securities at December 31, 2025 -- NAARDEN, the Netherlands and MIAMI, ...

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM: NAMS) - **Event**: 2026 Emerging Outlook Biotech Summit - **Date**: February 11, 2026 Key Points Industry and Product Focus - NewAmsterdam Pharma is focused on the development of obicetrapib, a CETP inhibitor aimed at treating hyperlipidemia and associated cardiovascular risks [1][2] Clinical Trials and Study Updates - **PREVAIL Study**: Expected mid-year update on the study's readout timelines, with a commitment to provide updates based on event adjudication over two years [7][8] - **BROADWAY Study**: Demonstrated a 21% MACE (Major Adverse Cardiac Events) benefit, with event rates tracking in line with PREVAIL [7][8] - **Compliance Tracking**: Emphasis on patient compliance due to the long duration of outcome studies, with strategies in place to maintain patient engagement [16][17] Drug Efficacy and Safety - Obicetrapib shows the ability to achieve risk-based goals in 70%-80% of patients, with a convenient dosing regimen of a 10-mg oral pill [22] - The drug has demonstrated a reduction in Lp(a) levels by upwards of 50% and has potential implications for diabetes and Alzheimer's disease [23][52] - The safety profile is favorable, with lower adverse events compared to placebo, enhancing patient retention in studies [17][18] Market Opportunity - There are approximately 30 million patients in the U.S. not achieving risk-based goals despite being on treatment for hyperlipidemia, indicating a significant market opportunity [24][52] - The commercial landscape is expected to evolve positively, with NewAmsterdam positioned to leverage its differentiated drug profile against competitors [51][72] Competitive Landscape - NewAmsterdam is the only company with a CETP inhibitor in development, with expectations for regulatory approval in Europe and the U.S. [51][76] - The company plans to differentiate obicetrapib by emphasizing its broader benefits beyond LDL-C reduction, targeting various patient populations including those with diabetes and elevated Lp(a) levels [52][76] Regulatory and Launch Strategy - The U.S. filing is contingent on having outcomes data available at launch, while the European filing has already occurred [76] - The company is confident in its ability to launch successfully, drawing on the experience of its commercial team [70][72] Future Studies and Insights - Ongoing studies (VINCENT, RUBENS, REMBRANDT) will further explore the drug's efficacy, particularly regarding small LDL particle elimination [31][34] - The HORIZON study will provide insights into the contribution of Lp(a) to MACE benefits observed in BROADWAY, which may inform expectations for PREVAIL [79] Additional Insights - The design of the PREVAIL study is intended to avoid the pitfalls of previous CETP inhibitors, focusing on LDL reduction rather than HDL elevation [43][44] - The company has a strong leadership team with extensive experience in cardiology and lipidology, which is expected to enhance the study's execution and outcomes [42][43] This summary encapsulates the critical aspects of NewAmsterdam Pharma's conference call, highlighting the company's strategic focus, clinical developments, market opportunities, and competitive positioning within the biotech industry.

Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1] Company Overview - NewAmsterdam Pharma aims to improve patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials as a LDL-C lowering therapy [3] - Obicetrapib is being studied both alone and in fixed-dose combinations with ezetimibe, intended as an adjunct to statin therapy for patients with elevated LDL-C [3]

Core Insights - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, an oral CETP inhibitor, with EMA approval expected in the second half of 2026 [1][3][5] - The company is conducting multiple Phase 3 trials, including PREVAIL, REMBRANDT, and RUBENS, to evaluate the efficacy of obicetrapib in various patient populations [3][6] - NewAmsterdam reported a year-end cash balance of approximately $729 million, which is expected to support operations through anticipated clinical milestones [7] Clinical Development - Obicetrapib is being developed as a low-dose, once-daily therapy for patients with elevated LDL-C who are at risk of cardiovascular disease [2][12] - The PREVAIL trial is tracking overall MACE event rates in line with the BROADWAY trial, indicating promising results for cardiovascular outcomes [3][4] - The RUBENS trial has enrolled its first patients and aims to evaluate obicetrapib in patients with metabolic syndrome [1][3] Regulatory and Commercialization Plans - NewAmsterdam is preparing for a potential commercial launch in Europe, contingent upon EMA approval for obicetrapib and its fixed-dose combination with ezetimibe [3][5] - The company has submitted marketing authorization applications (MAAs) for both obicetrapib monotherapy and the fixed-dose combination [5] Financial Position - As of December 31, 2025, NewAmsterdam's cash, cash equivalents, and marketable securities balance is approximately $729 million, which is projected to be sufficient for ongoing operations and potential commercialization [7] Alzheimer's Disease Research - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key biomarker for Alzheimer's disease, suggesting a link between CETP inhibition and neurodegeneration [4][11] - NewAmsterdam plans to initiate a dedicated Alzheimer's trial in 2026 based on encouraging biomarker analysis results [3][6]

Summary of NewAmsterdam Pharma Company FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Event**: 37th Annual Healthcare Conference - **Date**: December 04, 2025 Key Points Industry and Product Development - **2026 Expectations**: The year is anticipated to be significant for NewAmsterdam, particularly with the PREVAIL CVOT study results expected in the second half of 2026 [3][4][6] - **Study Execution**: 2025 was marked by successful study executions and data releases, including publications in prestigious journals like the New England Journal of Medicine [4][5] Clinical Trial Insights - **Event Rate Tracking**: The company is monitoring event rates closely, with a projected relative risk reduction of 20% based on historical data from similar studies [5][6] - **Quality of Trials**: NewAmsterdam claims to exceed quality benchmarks in their trials, with a focus on maintaining patient retention and adherence [12][39] Regulatory and Commercial Strategy - **Regulatory Filings**: The European Medicines Agency (EMA) has accepted the regulatory filing for obicetrapib, with Menarini as the partner responsible for the launch in Europe [15][17] - **Pricing Strategy**: Menarini is conducting scenario planning for pricing, considering the drug's value in LDL lowering and other health benefits [17][18] Market Positioning and Launch Strategy - **NDA Filing**: The company plans to file a New Drug Application (NDA) in the first half of 2026, aiming to maximize the product label with outcome study data [19][20] - **Combination Studies**: Ongoing studies, such as the Tandem study, are exploring the combination of obicetrapib with PCSK9 inhibitors, which is crucial for positioning against competitors [22][24] Patient Engagement and Market Acceptance - **Patient Motivation**: The drug is expected to resonate well with patients due to its multifaceted benefits, including LDL-C lowering, diabetes prevention, and potential Alzheimer's benefits [27][28] - **Awareness of Lipoprotein(a)**: There is an increasing awareness and understanding of Lipoprotein(a) as a risk factor among patients, which could enhance the market for obicetrapib [30][31] Safety and Efficacy - **Safety Profile**: The safety profile of obicetrapib is emphasized as a significant advantage, especially in a market where patients are increasingly concerned about drug safety [38][39] - **Combination Therapy Potential**: The drug's compatibility with other therapies is highlighted as a key factor for its future success [40] Future Studies and Data - **HORIZON Trial**: The HORIZON trial is expected to read out in the first half of 2026, potentially before the PREVAIL results, which could provide additional insights into the drug's efficacy [33][34] Additional Insights - **Market Dynamics**: The evolving landscape of patient expectations and the increasing focus on personalized medicine are shaping the approach to drug development and marketing strategies [26][27] - **Long-term Vision**: The company is committed to exploring various life cycle management options for obicetrapib, indicating a strategic focus on sustained market presence and adaptability [40]

Financial Data and Key Metrics Changes - The company reported a significant milestone in 2025, completing three phase 3 trials for its drug, which is expected to lead to regulatory submissions globally [3] - The BROADWAY trial demonstrated a 21% relative risk reduction in major adverse cardiac events (MACE) among 2,500 patients, indicating strong efficacy [3][4] - The drug showed a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [4][6] Business Line Data and Key Metrics Changes - The drug, obicetrapib, is positioned as a differentiated therapy due to its ability to lower Lp(a) and reduce diabetes risk, alongside LDL cholesterol lowering [4][6] - The company is focusing on the Alzheimer's prevention benefit of obicetrapib, which has shown promising results in patients with the APOE4 gene variant [5][17] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing effective LDL lowering therapies due to new guidelines emerging from studies like VESALIUS, which demonstrated mortality benefits from lowering LDL below 55 [56][57] - The partnership with Menarini is expected to enhance market penetration in Europe, leveraging their extensive sales force of 6,000 representatives [53] Company Strategy and Development Direction - The company aims to position obicetrapib as the go-to therapy for patients needing LDL lowering, particularly those with high Lp(a) levels, while also addressing diabetes and Alzheimer's prevention [58][62] - The strategy includes conducting additional studies to further validate the drug's benefits and potentially accelerate its approval process [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing PREVAIL study, which is expected to provide critical data for regulatory submissions and market positioning [8][12] - The management highlighted the importance of addressing skepticism in the medical community regarding CETP inhibitors and emphasized the need for robust data from PREVAIL to support the drug's launch [81] Other Important Information - The company is planning to conduct economic outcome studies to support payer arguments and demonstrate the cost-effectiveness of obicetrapib [76] - The management noted that the Alzheimer's benefit is gaining traction among lipidologists and cardiologists, which could enhance the drug's acceptance in the market [87] Q&A Session Summary Question: What is the expected peak sales potential for obicetrapib? - Management indicated that consensus estimates hover around $2-3 billion, while they believe the peak sales potential could exceed $8 billion, largely due to the drug's cardiovascular benefits [42] Question: How does the company plan to address global pricing strategies? - The company aims to harmonize pricing globally, learning from past pricing strategies of other companies, and ensuring broad access at launch [71][72] Question: What are the key differentiators of obicetrapib compared to other therapies? - The drug's ability to lower Lp(a) significantly, alongside its safety and tolerability profile, positions it as a preferred option for patients needing LDL lowering [62][68]

Financial Data and Key Metrics Changes - The company reported a significant milestone in 2025, completing three phase 3 trials for regulatory approval, with a notable 21% reduction in major adverse cardiac events (MACE) in the BROADWAY trial involving 2,500 patients [3][4][6] - The drug obicetrapib demonstrated a 50% reduction in Lp(a) levels, which is a significant differentiator from other lipid-lowering therapies [4][6] Business Line Data and Key Metrics Changes - The BROADWAY trial results highlighted the drug's efficacy in lowering LDL cholesterol by approximately 40%, with a combination with ezetimibe achieving a 50% reduction [6] - The company is focusing on the Alzheimer's prevention benefit of obicetrapib, which has shown promising results in patients with the APOE4 gene variant [5][17] Market Data and Key Metrics Changes - The company anticipates a significant increase in the market for LDL-lowering therapies due to new guidelines that recommend more aggressive treatment for patients with atherosclerotic disease [56] - The partnership with Menarini, which has a large sales force in Europe, is expected to enhance market penetration and distribution capabilities [53][51] Company Strategy and Development Direction - The company aims to position obicetrapib as the go-to oral agent for lowering Lp(a) and LDL cholesterol, emphasizing its safety and tolerability [59][61] - Future studies, including a phase 2B trial focusing on Alzheimer's prevention, are planned to further validate the drug's benefits [29][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing PREVAIL study, which is expected to provide critical data for regulatory approval and market entry [8][12] - The company is optimistic about the potential for obicetrapib to address unmet medical needs in cardiovascular and Alzheimer's disease prevention [7][19] Other Important Information - The company has published significant findings in reputable journals, which have positively influenced the medical community's perception of obicetrapib [51][50] - Management highlighted the importance of economic outcomes in supporting payer arguments for the drug's value [76][70] Q&A Session Summary Question: What is the expected peak sales potential for obicetrapib? - Management indicated that consensus estimates hover around $2-3 billion, while the company believes peak sales potential could exceed $8 billion, primarily driven by cardiovascular benefits [42][49] Question: How does the company plan to address skepticism regarding CETP inhibitors? - Management acknowledged the need for robust data from the PREVAIL trial to alleviate concerns and emphasized the positive results from the BROADWAY trial as a foundation for confidence [81][80] Question: What are the implications of new treatment guidelines for LDL-lowering therapies? - Management noted that new guidelines could significantly expand the patient population requiring treatment, emphasizing the need for effective therapies like obicetrapib [56][57]

Financial Data and Key Metrics Changes - The company reported a significant reduction in major adverse cardiac events (MACE) by 21% in the BROADWAY trial, which included 2,500 patients, indicating strong efficacy of their drug [4][7] - The drug demonstrated a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [5][58] Business Line Data and Key Metrics Changes - The BROADWAY trial results have positioned the drug as a differentiated therapy in the lipid-lowering market, with additional benefits in diabetes risk reduction and potential Alzheimer's prevention [6][21] - The company is preparing for the PREVAIL study, which is expected to provide further validation of the drug's efficacy and safety [9][14] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing aggressive LDL treatment due to new guidelines emerging from studies like VESALIUS, which showed mortality benefits from lowering LDL below 55 [54][55] - The partnership with Menarini is expected to enhance market access in Europe, leveraging their extensive sales force of 6,000 representatives [52][50] Company Strategy and Development Direction - The company aims to position its drug as the go-to option for patients requiring LDL lowering, emphasizing its unique benefits beyond traditional lipid-lowering therapies [56][57] - Future studies are planned to explore the drug's effects on Alzheimer's and diabetes, with a focus on expanding its therapeutic indications [76][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address unmet medical needs in cardiovascular health and Alzheimer's prevention, highlighting the growing recognition of its benefits in the medical community [8][20] - The company is committed to maintaining a strong adherence to study protocols in ongoing trials, which is crucial for regulatory approval and market success [9][13] Other Important Information - The company has published significant findings in reputable journals, enhancing its credibility and visibility in the medical community [50][19] - The management is exploring partnerships for funding large-scale studies to mitigate financial risks associated with drug development [31][34] Q&A Session Summary Question: What is the expected impact of the PREVAIL study on the drug's market potential? - Management indicated that the PREVAIL study is crucial for validating the drug's efficacy and will inform the timing of regulatory filings for U.S. approval [14][15] Question: How does the company plan to address skepticism regarding CETP inhibitors? - The management acknowledged the need to address skepticism and emphasized the importance of robust data from the BROADWAY trial to build confidence among healthcare providers [78][50] Question: What are the anticipated guidelines for LDL treatment following recent studies? - Management expects that new guidelines will significantly increase the number of patients requiring treatment, particularly those with atherosclerotic disease [54][55]

Summary of NewAmsterdam Pharma Company FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Focus**: Cholesterol-lowering therapies, specifically the drug obicetrapib Key Points Industry Context - The cholesterol-lowering market is significant, with approximately **30 million patients** in the U.S. diagnosed with hypercholesterolemia who are not achieving their LDL goals [21] - The market for lipid-lowering therapies is projected to be **$5 billion or higher** [63] Product Development and Regulatory Timeline - NewAmsterdam has completed three positive Phase III studies for obicetrapib, focusing on LDL reduction [9] - Regulatory filing in Europe has been accepted, with approval expected in **2026** [9] - The U.S. regulatory filing is dependent on the outcomes of the PREVAIL study, which is expected to provide data at the time of commercial launch [11][17] Competitive Landscape - NewAmsterdam positions obicetrapib as a unique CETP inhibitor, differentiating it from PCSK9 therapies [16] - Merck is also developing a PCSK9 therapy, with plans to file for approval in the first half of **2026** [44] - The company believes it can outperform Merck in market share due to the distinct advantages of obicetrapib [59] Clinical Data and Efficacy - Obicetrapib is expected to achieve **35%-40%** LDL reduction as a monotherapy and **50%-55%** in combination with ezetimibe [42] - The drug has shown a **15% reduction** in the rate of new-onset diabetes, which is a significant benefit for patients at risk [22] - The adverse event profile of obicetrapib is favorable, with lower rates of adverse events compared to placebo [43] Market Access and Pricing Strategy - The focus is on maximizing payer access at launch, with pricing strategies aligned with existing market frameworks [26] - The current pricing paradigm in the U.S. involves high list prices with lower net prices due to discounting [27] Future Opportunities - NewAmsterdam is exploring the potential of obicetrapib in treating Alzheimer's, with plans for a Phase IIB trial focusing on biomarkers related to Alzheimer's function [86] - The company aims to engage with the FDA to discuss the path forward for Alzheimer's treatment [88] Methodology and Data Reporting - NewAmsterdam uses the beta-quant method for LDL measurement, which is consistent with industry standards [82] - The company is aware of the variability in LDL measurement methods and aims to provide clarity in its data reporting [80] Conclusion - NewAmsterdam Pharma is positioned to enter the cholesterol-lowering market with a unique product that addresses significant unmet needs. The company is focused on regulatory approvals, competitive differentiation, and maximizing market access while exploring additional therapeutic areas such as Alzheimer's.

Merck & Co (NYSE:MRK) FY Conference Summary Industry and Company Overview - **Company**: Merck & Co (MRK) - **Industry**: Pharmaceuticals, specifically focusing on R&D in various therapeutic areas including cardiovascular, oncology, immunology, and ophthalmology Key Points and Arguments R&D Developments - **Cadence Trial**: - The trial was a success, providing strong evidence to move to phase three in 2026 for patients with pulmonary hypertension caused by heart failure with preserved ejection fraction [4][5][6] - The trial results were promising, but did not meet the criteria for FDA submission [4] - Enrollment challenges were noted due to restrictive inclusion criteria, but interest increased towards the end of the trial [6][8] - **WINREVAIR (Cetaricept)**: - Confidence in the trajectory remains strong, with 75% of patients in the U.S. being from severe cases [10][11] - Steady growth of 500-600 patients per month is expected as the drug launches outside the U.S. [11] - **PCSK9 (Obicetrapib)**: - Expected to be a game changer with significant LDL cholesterol reduction [14] - The drug has a favorable adverse event profile comparable to placebo, which is crucial for broad access [15][16] - Pricing strategy aims for broad access without being a barrier [19] Oncology Pipeline - **Trop2 ADC**: - Unique dosing strategy and development approach differentiate it from competitors [25] - Ongoing studies show positive results, validating the efficacy of the drug [26] - **Nembtu-Brutinib**: - Focused on front-line treatment to avoid resistance, with a larger study planned [30][31] - Expected to demonstrate non-inferiority and potentially superiority over competitors [32] - **PD-1 VEGF**: - Cautious optimism regarding efficacy and overall survival (OS) benefits, with a disciplined approach to development [36][37] - The company is waiting for definitive OS signals before committing significant resources [41] Ophthalmology and Immunology - **iBio Acquisition**: - Addresses unmet medical needs in diabetic macular edema (DME) and age-related macular degeneration (AMD) [49][52] - The program is advancing rapidly, with a significant market opportunity identified [52] - **TL1A in Immunology**: - New mechanism of action (MOA) expected to provide significant benefits in inflammatory bowel disease (IBD) [87][88] - The company is optimistic about the commercial potential despite perceived infrastructure challenges [87][88] Financial and Market Outlook - **Commercial Opportunities**: - Merck has identified over $50 billion in commercial opportunities from its existing pipeline by the mid-2030s [104] - The company is focused on de-risking its pipeline with multiple readouts expected in 2026 [104] - **KEYTRUDA Patent Expiration**: - The composition of matter patent for KEYTRUDA is set to expire in December 2028, with additional patents extending into 2029 [105] Other Important Insights - **Market Dynamics**: - The company is aware of the competitive landscape and is strategically positioning its products to address unmet needs [72][88] - There is a focus on rational combinations in immunology, leveraging new MOAs while being cautious about adverse events [99][100] - **Regulatory and Clinical Strategy**: - The company emphasizes the importance of patient selection and rigorous clinical trial design to ensure successful outcomes [92][93] This summary encapsulates the key discussions and insights from the Merck & Co FY Conference, highlighting the company's strategic direction, R&D advancements, and market positioning.