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.