NewAmsterdam Pharma Company (NAMS) investor relations material

Clinical trial progress and interim analysis

• PREVAIL, a 9,500-patient outcome study, is progressing on or ahead of schedule, with an interim analysis set for the end of the year and readout in Q1 next year.

• The interim analysis is designed to potentially allow early trial completion if both three-point and four-point MACE endpoints are met, aiming for regulatory certainty.

• Event rates in PREVAIL are lower than expected, consistent with prior BROADWAY trial results, supporting confidence in the drug's efficacy.

• The four-point MACE definition was updated to include total revascularization, increasing event counts by 20-24% and aligning with recent trial standards.

• The trial is now powered for a 15% relative risk reduction, reflecting contemporary LDL trial benchmarks.

Commercial and competitive landscape

• Uptake is expected to be driven by positive outcome data and additional benefits such as Lp(a) lowering, diabetes risk reduction, and Alzheimer's biomarker improvements.

• New guidelines have expanded the addressable market, potentially doubling the patient pool to over 55 million.

• Oral PCSK9 competitors are seen as market expanders rather than threats, with obicetrapib positioned for unique benefits.

• Safety, tolerability, and ease of use are highlighted as key factors for broad adoption, especially among primary care providers.

Regulatory and pricing strategy

• European regulatory filings are complete, with approvals expected in Germany and the UK this year and launches planned with partner Menarini.

• Pricing strategies are being coordinated to align with U.S. pricing, considering the complexities of European markets and MFN policies.

• U.S. regulatory discussions are ongoing, with the goal of launching with outcome data in hand.