NewAmsterdam Pharma Company (NasdaqGM:NAMS) FY Conference Transcript

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]