NewAmsterdam Pharma pany N.V.(NAMS) - 2025 FY - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a significant milestone in 2025, completing three phase 3 trials for its drug, which is expected to lead to regulatory submissions globally [3] - The BROADWAY trial demonstrated a 21% relative risk reduction in major adverse cardiac events (MACE) among 2,500 patients, indicating strong efficacy [3][4] - The drug showed a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [4][6] Business Line Data and Key Metrics Changes - The drug, obicetrapib, is positioned as a differentiated therapy due to its ability to lower Lp(a) and reduce diabetes risk, alongside LDL cholesterol lowering [4][6] - The company is focusing on the Alzheimer's prevention benefit of obicetrapib, which has shown promising results in patients with the APOE4 gene variant [5][17] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing effective LDL lowering therapies due to new guidelines emerging from studies like VESALIUS, which demonstrated mortality benefits from lowering LDL below 55 [56][57] - The partnership with Menarini is expected to enhance market penetration in Europe, leveraging their extensive sales force of 6,000 representatives [53] Company Strategy and Development Direction - The company aims to position obicetrapib as the go-to therapy for patients needing LDL lowering, particularly those with high Lp(a) levels, while also addressing diabetes and Alzheimer's prevention [58][62] - The strategy includes conducting additional studies to further validate the drug's benefits and potentially accelerate its approval process [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing PREVAIL study, which is expected to provide critical data for regulatory submissions and market positioning [8][12] - The management highlighted the importance of addressing skepticism in the medical community regarding CETP inhibitors and emphasized the need for robust data from PREVAIL to support the drug's launch [81] Other Important Information - The company is planning to conduct economic outcome studies to support payer arguments and demonstrate the cost-effectiveness of obicetrapib [76] - The management noted that the Alzheimer's benefit is gaining traction among lipidologists and cardiologists, which could enhance the drug's acceptance in the market [87] Q&A Session Summary Question: What is the expected peak sales potential for obicetrapib? - Management indicated that consensus estimates hover around $2-3 billion, while they believe the peak sales potential could exceed $8 billion, largely due to the drug's cardiovascular benefits [42] Question: How does the company plan to address global pricing strategies? - The company aims to harmonize pricing globally, learning from past pricing strategies of other companies, and ensuring broad access at launch [71][72] Question: What are the key differentiators of obicetrapib compared to other therapies? - The drug's ability to lower Lp(a) significantly, alongside its safety and tolerability profile, positions it as a preferred option for patients needing LDL lowering [62][68]