NewAmsterdam Pharma Company (NAMS) FY Earnings Call Presentation

Obicetrapib Clinical Development and Market Opportunity - Obicetrapib is designed to address the significant unmet need for oral LDL-C lowering therapy as an adjunct to statins, targeting over 30 million patients in the US who are not achieving LDL-C lowering goals[7, 11] - Obicetrapib demonstrated a 43% mean LDL-C lowering as monotherapy and a 59% mean LDL-C lowering in combination with ezetimibe, observed on top of high-intensity statins[8] - The lipid-lowering therapy market is a growing opportunity, with over 250 million prescriptions written in the past 12 months and a market growth of over 4% in the last 2 years[16] - Approximately 75% of ASCVD patients are not at their risk-based LDL-C goal, highlighting the need for more effective treatments[23] PREVAIL CVOT Trial Design and Potential Benefits - The PREVAIL CVOT is designed to apply lessons learned from previous CVOTs to reduce risk and demonstrate Obicetrapib's full benefit, targeting higher baseline LDL-C patients and a longer duration of follow-up[32] - Phase 2 efficacy data applied to PREVAIL baseline data predicts at least a 20% MACE benefit projection across multiple biomarkers[34, 35, 37, 40] - The PREVAIL study inclusion criteria requires high baseline LDL-C (also translates to high ApoB) and risk enhancers will increase high-risk patient populations[62] Upcoming Milestones and Data Readouts - Multiple potential pivotal data readouts are expected in the next 12 months from Phase 3 BROADWAY, BROOKLYN, and Phase 2b Japan trials[42, 43] - Enrollment is complete for the BROOKLYN Phase 3 trial, and topline results are expected in Q4 2024, while BROADWAY Phase 3 topline results are expected in Q3 2024[65] Addressing Limitations of Existing Therapies - Obicetrapib program is designed to overcome limitations of prior CETP inhibitors, with a 97% CETP inhibition at a 10mg dose, and demonstrated Lp(a) lowering of 47-57%[28]