-- EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 -- -- Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY -- -- First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome -- -- Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) -- NAARDEN, the Netherlands and MIAMI, Jan. 09, 2 ...

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.

Core Insights - The investment represents a multi-million-dollar upgrade in equipment to enhance production capabilities for fixed dose combination (FDC) products [1][4] - The new manufacturing suite at the Sellersville facility will support the production of NewAmsterdam Pharma's investigational non-statin cholesterol medication aimed at reducing LDL-C [2][4] - The partnership between Piramal Pharma Solutions and NewAmsterdam Pharma is crucial for the development and production of the FDC, with significant contributions from Piramal's facilities in India [2][4] Company Developments - The new suite is expected to create over 20 new jobs at the Sellersville site over the next five years, contributing positively to the local economy [3] - The investment reflects a commitment to continuous improvement and operational efficiency, enabling both companies to meet future commercial demands for the FDC product [4] - NewAmsterdam Pharma is focused on developing obicetrapib, a low-dose CETP inhibitor, to address unmet needs in LDL-lowering therapies [5][6] Industry Context - NewAmsterdam Pharma operates in the late-stage clinical biopharmaceutical sector, targeting metabolic diseases with inadequate existing therapies [6] - Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing comprehensive services across the drug life cycle, enhancing its capabilities through this investment [7][8]

Core Insights - NewAmsterdam Pharma is set to present full data from the Alzheimer's Disease biomarker analyses in the BROADWAY clinical trial at the Alzheimer's Association International Conference on July 30, 2025 [1][2] Company Overview - 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][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has observed statistically significant LDL-lowering effects in multiple Phase 2 trials, with a side effect profile similar to that of placebo [5] - NewAmsterdam commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, enrolling over 9,500 patients [5] Upcoming Events - The presentation titled "Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular Disease" will take place on July 30, 2025, at 8:21 AM ET [2] - A live webcast and conference call will be hosted by NewAmsterdam at 10:00 AM ET on the same day to review the full AD biomarker data [2][3]