NewAmsterdam Pharma Company (NAMS) 25th Annual Needham Virtual Healthcare Conference summary

Clinical development highlights

• Three pivotal phase III studies showed consistent LDL reduction (35%-40% for monotherapy, ~50% for fixed-dose combination) and strong safety profile over the past 18 months.

• Early MACE signal in BROADWAY showed a 21% benefit, exceeding expectations based on LDL reduction alone.

• PREVAIL, the main outcome study, is designed with high baseline LDL, exclusion of heart failure patients, and a minimum 2.5-year follow-up to maximize success and predictability.

• Additional phase III trials (REMBRANDT, RUBENS) target imaging outcomes and metabolic syndrome populations, with RUBENS expected to complete by year-end.

• Alzheimer's and diabetes benefits are being explored, with a dedicated phase II Alzheimer's study planned for later this year.

Commercial and regulatory strategy

• Preparing for U.S. launch of both monotherapy and fixed-dose combination, expanding commercial leadership and infrastructure.

• U.S. launch will follow public disclosure of outcomes data, not necessarily requiring label inclusion; payer feedback supports this approach.

• European partner expects CHMP recommendation and formal approval in the second half of this year, with launches in Germany and the U.K. to follow.

• European launch timelines are not a proxy for U.S. due to country-specific pricing and access processes.

• Commercial costs remain low until regulatory approval nears, with sales force hiring planned closer to launch.

Market landscape and differentiation

• Updated treatment guidelines expand the target population, now including earlier intervention and lower LDL goals, increasing the addressable market.

• Fixed-dose combination achieves LDL goals in up to 70% of high-risk patients, outperforming current therapies.

• Obicetrapib offers additional benefits for Lp(a), diabetes, and small LDL particles, differentiating it from PCSK9s and other oral agents.

• Future development includes combinations with statins, PCSK9s, Lp(a) agents, and oral GLP-1s, broadening the pipeline.

• Market research indicates strong physician and patient preference for oral therapies over injectables.