NewAmsterdam Pharma Company (NAMS) Citi Annual Global Healthcare Conference 2025 summary

Key clinical trial updates and results

• Completed three phase 3 trials, including BROADWAY, supporting global regulatory submissions and showing strong LDL lowering and tolerability, with a 21% reduction in major adverse cardiac events (MACE).

• Obicetrapib demonstrated significant lowering of Lp(a) by about 50%, a key differentiator from statins and other lipid drugs.

• BROADWAY data revealed benefits in diabetes risk reduction and a novel Alzheimer's prevention signal, especially in APOE4 carriers, with strong biomarker improvements.

• PREVAIL, the key outcome study, is progressing well with low dropout rates and is expected to provide an update on timing by mid-next year, with final results anticipated in 2026.

• Additional studies include a phase 2B Alzheimer's trial, a diabetes study (RUBY), and ongoing Lp(a) research, with economic outcomes being assessed.

Differentiation and market positioning

• Obicetrapib offers multiple benefits beyond LDL lowering, including Lp(a) reduction, diabetes risk reduction, and Alzheimer's biomarker improvement.

• The drug is positioned as a well-tolerated, easy-to-take oral therapy, expected to become the go-to option after statins for patients needing aggressive LDL lowering.

• Recent guideline changes and new data (e.g., VESALIUS) are expanding the eligible patient population for intensive LDL lowering.

• Obicetrapib's unique profile is expected to drive broad adoption, especially among patients with high Lp(a) or those at risk for Alzheimer's.

• The company is leveraging strong academic and KOL support, with extensive publications in top journals and a robust partnership with Menarini for European commercialization.

Commercial and regulatory strategy

• Peak sales consensus is $2-3 billion, but internal estimates exceed $8 billion, based solely on cardiovascular outcomes, with no Alzheimer's value currently included.

• The FDA's harmonized labeling for lipid-lowering therapies is expected to benefit obicetrapib upon approval.

• Menarini will set European pricing, with a collaborative approach to global branding and commercial strategy.

• The company aims for broad access at launch, learning from past pricing missteps in the PCSK9 market, and is preparing health economic studies to support payer negotiations.

• Potential for accelerated approval in Alzheimer's prevention exists if phase 2B and PREVAIL data are compelling, with external funding options being explored for larger trials.