NewAmsterdam Pharma Company (NAMS) Conference Transcript

Summary of NewAmsterdam Pharma Company (NAMS) Conference Call Company Overview - Company: NewAmsterdam Pharma Company (NAMS) - Event: Citi Back to School Biopharma Conference - Date: September 03, 2025 Key Points Industry and Product Development - NewAmsterdam Pharma has made significant progress in Phase III trials, particularly with obicetropib, demonstrating a 21% reduction in major adverse cardiovascular events (MACE) and showing safety comparable to placebo [3][5] - The company has published multiple studies in prestigious journals, including the New England Journal of Medicine and Lancet, highlighting the efficacy of their drug in lowering LDL and other cardiovascular risk factors [4][5] - The PREVAIL trial is fully enrolled and on track to finish late next year, with positive recommendations from Data Safety Monitoring Board (DSMB) meetings [5][34] Clinical Data and Efficacy - The drug not only lowers LDL but also shows benefits in lowering LpLA, small particles, and diabetes risk, with additional promising results in Alzheimer's biomarkers for APOE4 patients [6][20] - The company is optimistic about the drug's potential to provide significant benefits in Alzheimer's treatment, particularly for high-risk patients [22][50] - The totality of data suggests that the drug could be positioned as a foundational therapy in cardiometabolic health, with potential for combination therapies [55][64] Market Position and Strategy - NewAmsterdam Pharma aims to address skepticism in the cardiology community regarding CTP inhibitors by emphasizing clinical data and outcomes from ongoing trials [12][14] - The company is actively engaging with payers to ensure favorable reimbursement and access for their drug upon launch [16][17] - The strategy includes a focus on the LDL-lowering benefits as the cornerstone of the drug's value proposition, while also promoting its additional benefits [76] Future Development and Partnerships - The company plans to pursue partnerships in Asia (Japan and China) while maintaining control over the U.S. market to maximize shareholder value [89][90] - NewAmsterdam Pharma is looking for partners with a strong cardiovascular presence, particularly in primary care, to help commercialize their product effectively [92][95] - The company is also exploring the potential for combination therapies with other drugs, such as GLP-1 and SGLT-2 inhibitors, to enhance diabetes prevention and cardiovascular outcomes [72][74] Regulatory and Market Considerations - The company has filed for EMA approval in Europe, which was accepted, and is preparing for potential FDA discussions regarding accelerated approval based on their clinical data [5][88] - NewAmsterdam Pharma is aware of the regulatory environment and is strategizing to navigate challenges, including the potential impact of the pill penalty on oral medications [81][84] Conclusion - NewAmsterdam Pharma is positioned to make a significant impact in the biopharma industry with its innovative drug, obicetropib, which addresses both cardiovascular and potential Alzheimer's disease pathways. The company is focused on leveraging clinical data, engaging with stakeholders, and exploring strategic partnerships to maximize the drug's market potential and patient access [3][19][88]