NewAmsterdam Pharma Company (NAMS) TD Cowen 46th Annual Health Care Conference summary

Key clinical results and drug differentiation

• Completed pivotal Phase III trials (BROOKLYN, TANDEM, BROADWAY) showing strong LDL lowering, excellent tolerability, and a 21% MACE reduction at 12 months when data are pooled.

• Obicetrapib demonstrated significant HDL increase (150%), 90% reduction in small LDL particles, and 50% Lp(a) lowering in key patient groups.

• BROADWAY data showed reductions in amyloid biomarkers in APOE4 carriers, suggesting potential Alzheimer's benefit.

• CETP inhibition with obicetrapib is associated with reduced diabetes risk, unlike statins.

• Fixed-dose combination with ezetimibe achieves LDL reductions comparable to injectables like Repatha.

Market landscape and commercial strategy

• The lipid-lowering market is expanding rapidly, with more aggressive LDL targets (<55 mg/dL) driving demand for combination therapies.

• Approximately 90% of patients cannot reach new LDL targets with statins alone, increasing the need for additional therapies.

• Obicetrapib is positioned as an oral, well-tolerated alternative with broad lipid benefits, targeting both primary and secondary prevention populations.

• Commercial launch in Europe is planned for late 2024, with EMA approval expected and Menarini as the launch partner.

• U.S. launch strategy hinges on having PREVAIL outcomes data public at launch to maximize payer access and label claims.

Ongoing and future clinical development

• PREVAIL, a large cardiovascular outcomes trial, will complete its 2.5-year follow-up by end of 2024, with updates expected mid-year and final data by end of 2026.

• RUBENS (diabetes population) and REMBRANDT (plaque volume) studies are underway to expand label indications and provide additional efficacy data.

• Plans for further Alzheimer's-focused trials are in development, building on promising biomarker results.