Company Overview - NewAmsterdam Pharma Company N.V. is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [1][3] - The company aims to address the unmet need for safe, well-tolerated, and convenient LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Product Development - NewAmsterdam is conducting multiple phase 3 trials for obicetrapib, an oral, low-dose, once-daily CETP inhibitor, which is being investigated as a standalone treatment and in combination with ezetimibe [3] - The target population includes patients at risk of CVD with elevated LDL-C levels, for whom current therapies are insufficiently effective or poorly tolerated [3] Upcoming Events - The company will participate in several investor conferences: - William Blair 45th Annual Growth Stock Conference in Chicago, IL on June 3, 2025, with a presentation by CEO Michael Davidson at 3:20 p.m. CT [4] - Jefferies Global Healthcare Conference 2025 in New York, NY on June 4, 2025, featuring a fireside chat with CFO Ian Somaiya at 10:30 a.m. ET [4] - Goldman Sachs 46th Annual Healthcare Conference in Miami, FL on June 9, 2025, with participation from CEO Michael Davidson and EVP Matthew Philippe at 2:40 p.m. ET [4] Investor Relations - Live webcasts of the presentations will be available on the investor relations section of the NewAmsterdam Pharma website, with archived replays accessible afterward [2]

Core Insights - Esperion Therapeutics has entered into a license and distribution agreement with HLS Therapeutics for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Canada, which will enhance access to these cardiovascular therapies for 2.6 million Canadians living with diagnosed heart disease [1][4][2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing non-statin medications for patients at risk for cardiovascular disease, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [7][8] - HLS Therapeutics, established in 2015, specializes in the acquisition and commercialization of late-stage and established pharmaceutical products, particularly in the areas of psychiatric disorders and cardiovascular disease [6] Financial Terms of the Agreement - Under the agreement, Esperion will receive an upfront payment, milestone payments of up to approximately $5 million, and tiered royalties on product sales [5][4] - Esperion will supply finished products to HLS Therapeutics at a profitable transfer price, while HLS will handle commercialization, including reimbursement and marketing [4][5]

Core Insights - NewAmsterdam Pharma has presented compelling clinical data from the BROADWAY and TANDEM Phase 3 trials, demonstrating significant reductions in LDL-C and Lp(a) levels, which are critical for patients at risk of cardiovascular disease [1][2][6] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications for patients with elevated LDL-C who are at risk of cardiovascular disease [1][13] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for improving LDL-C levels [8][13] Clinical Trial Findings - The BROADWAY trial showed that obicetrapib reduced LDL-C by 50% when used with statins and by 35% as monotherapy, with a notable 21% reduction in major adverse cardiovascular events [4][5] - The TANDEM trial demonstrated that the fixed-dose combination of obicetrapib and ezetimibe achieved a statistically significant LDL-C reduction of 48.6% compared to placebo [3][4] - Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials indicated a median placebo-adjusted reduction of 45% in Lp(a) levels after 12 weeks of treatment [6][7] Market Context - Cardiovascular disease remains the leading cause of death globally, with a significant number of patients unable to reach their LDL-C goals despite the availability of lipid-lowering therapies [9][12] - Approximately 30 million under-treated adults in the U.S. are not at their risk-based LDL-C goal, highlighting a substantial clinical need for effective therapies [12] Future Prospects - The data presented at EAS 2025 is expected to support global regulatory filings for obicetrapib, reinforcing its potential as a foundational therapy in cardiovascular disease management [2][7] - The company has completed enrollment for the Phase 3 PREVAIL trial, which aims to assess the impact of obicetrapib on major adverse cardiovascular events [8]

Core Insights - Novo Nordisk's Rybelsus (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events (MACE) by 14% in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD) compared to placebo [2][7][8] - The SOUL trial, a phase 3b study, involved 9,650 participants and confirmed the cardiovascular benefits of Rybelsus, which is the only approved oral GLP-1 medicine [8][9] - Novo Nordisk has submitted a label extension application for Rybelsus to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for cardiovascular event risk reduction, with a decision expected in 2025 [6][7] Company Focus - Novo Nordisk is expanding its focus beyond diabetes and obesity to encompass a broader spectrum of metabolic and cardiovascular health, reinforcing its leadership in this area [4] - The company emphasizes the importance of patient-centric treatments to manage cardiovascular risks associated with type 2 diabetes [3] Clinical Trial Details - The SOUL trial achieved its primary endpoint, demonstrating a significant reduction in MACE, which includes cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke [2][8] - The safety profile of Rybelsus in the SOUL trial was consistent with previous studies, showing a lower incidence of serious adverse events compared to placebo [4][5] Market Position - Rybelsus is currently marketed in 45 countries, with over 2.1 million patients being treated worldwide, highlighting its significant market presence [9]