Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Key Personnel**: Founder and Chief Scientific Officer John Kastelein, Head of Investor Relations and Executive Vice President Matthew Philippe - **Focus**: Development of lipid-lowering therapies, particularly obicetrapib Core Points and Arguments - **Clinical Trials**: - Completed pivotal lipid-lowering registration studies: BROADWAY, BROOKLYN, and TANDEM, all published in reputable journals [2][3] - Current focus on PREVAIL trial, which is fully enrolled and aims to translate findings from BROADWAY, showing a 21% reduction in major adverse cardiovascular events (MACE) [2][3] - PREVAIL has four times the number of patients and a longer duration than BROADWAY, enhancing confidence in MACE reduction outcomes [3] - **Regulatory Filings**: - Applications filed in Europe for both monotherapy and fixed-dose combination, with expected approvals in the second half of next year [6] - U.S. filing timelines are contingent on PREVAIL outcomes data, with hopes for data availability by early 2026 [7][8] - **Efficacy Data**: - The 21% MACE reduction observed in BROADWAY is supported by Kaplan-Meier curves, indicating biological plausibility [10][11] - Analysis of previous trials suggests that MACE reductions in phase three trials typically translate to outcomes in larger trials [12] - **Lipid Dynamics**: - Focus on small LDL particles and lipoprotein(a) as significant contributors to cardiovascular risk, with obicetrapib showing a 90% reduction in small LDL particles [16][18] - Ongoing studies to establish the predictive value of LDL particles over traditional LDL cholesterol measurements [17] - **Lipoprotein(a) Insights**: - Anticipation of positive outcomes from the HORIZON trial, which will assess the impact of lipoprotein(a) lowering on MACE [20][21] - The relationship between lipoprotein(a) reduction and MACE is expected to be established, aiding in the understanding of obicetrapib's effects [21][22] - **Competitive Landscape**: - NewAmsterdam Pharma positions obicetrapib as the only CETP inhibitor, differentiating it from existing PCSK9 inhibitors [36][37] - Emphasis on the safety profile of obicetrapib as a key factor for broad market access [38] Other Important Content - **Alzheimer's Disease Biomarker Study**: Recent findings suggest obicetrapib may also impact Alzheimer's disease biomarkers, presenting a unique selling point [4][41] - **Patient Compliance and Trial Integrity**: The company has established robust tracking mechanisms for patient compliance in the PREVAIL trial, ensuring data integrity [31][34] - **Market Potential**: The lipid management market is expected to accommodate multiple successful therapies, with NewAmsterdam Pharma aiming for a significant share due to its differentiated product profile [36][38] This summary encapsulates the key discussions and insights from the NewAmsterdam Pharma conference call, highlighting the company's strategic direction, clinical trial progress, and competitive positioning in the lipid-lowering market.

Financial Data and Key Metrics Changes - The company expects approval in Europe within the next 12 months, with a projected 33% to 36% reduction in LDL-C for monotherapy and approximately 49% for the fixed-dose combination [8][10] - The global market opportunity for the drug is estimated to exceed $8 billion, with potential revenue splits favoring the U.S. [17][18] Business Line Data and Key Metrics Changes - The company has initiated three LDL studies, with positive data released last year supporting the European filing accepted by the EMA [3][4] - The drug shows a unique ability to reduce Lp(a) by 40% to 50%, which is significantly higher than existing therapies [4][47] Market Data and Key Metrics Changes - The pricing strategy in Europe will be determined by the partner Menarini, with a focus on broad access to lipid-lowering therapies [12][16] - The company anticipates a slower launch pace in Europe compared to the U.S. due to country-by-country approval processes [19][20] Company Strategy and Development Direction - The company aims to redefine hyperlipidemia treatment with its drug, focusing on both LDL and Lp(a) reduction [3][4] - The strategy includes leveraging outcomes data to enhance market access and pricing negotiations in the U.S. [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's unique characteristics and its potential to resonate with both clinicians and patients [5][48] - The company is optimistic about the PREVAIL study's outcomes, expecting to report a MACE benefit of over 20% [35][36] Other Important Information - The company has a strong intellectual property position, with patents extending to 2043 in the U.S. [60] - The collaboration with Menarini is seen as beneficial due to their established presence in the cardiovascular space [17] Q&A Session Summary Question: What is the expected timeline for EU approval? - The company expects approval in the next 12 months, with the outcome study not being a gating factor for the approval process [10][11] Question: How does the pricing strategy work in Europe? - The pricing will be determined by Menarini, with a focus on broad access within established price bands for lipid-lowering therapies [12][16] Question: What is the rationale behind the U.S. filing strategy? - The company aims to launch with the broadest possible label, leveraging outcomes data to enhance market access [22][24] Question: How does the company differentiate its drug from existing therapies? - The drug offers significant reductions in both LDL and Lp(a), addressing residual risks that current therapies do not [47][48] Question: What is the confidence level in the intellectual property position? - The company is confident in its IP estate, with patents in place until 2043 [60]