Summary of NewAmsterdam Pharma Company FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Event**: 37th Annual Healthcare Conference - **Date**: December 04, 2025 Key Points Industry and Product Development - **2026 Expectations**: The year is anticipated to be significant for NewAmsterdam, particularly with the PREVAIL CVOT study results expected in the second half of 2026 [3][4][6] - **Study Execution**: 2025 was marked by successful study executions and data releases, including publications in prestigious journals like the New England Journal of Medicine [4][5] Clinical Trial Insights - **Event Rate Tracking**: The company is monitoring event rates closely, with a projected relative risk reduction of 20% based on historical data from similar studies [5][6] - **Quality of Trials**: NewAmsterdam claims to exceed quality benchmarks in their trials, with a focus on maintaining patient retention and adherence [12][39] Regulatory and Commercial Strategy - **Regulatory Filings**: The European Medicines Agency (EMA) has accepted the regulatory filing for obicetrapib, with Menarini as the partner responsible for the launch in Europe [15][17] - **Pricing Strategy**: Menarini is conducting scenario planning for pricing, considering the drug's value in LDL lowering and other health benefits [17][18] Market Positioning and Launch Strategy - **NDA Filing**: The company plans to file a New Drug Application (NDA) in the first half of 2026, aiming to maximize the product label with outcome study data [19][20] - **Combination Studies**: Ongoing studies, such as the Tandem study, are exploring the combination of obicetrapib with PCSK9 inhibitors, which is crucial for positioning against competitors [22][24] Patient Engagement and Market Acceptance - **Patient Motivation**: The drug is expected to resonate well with patients due to its multifaceted benefits, including LDL-C lowering, diabetes prevention, and potential Alzheimer's benefits [27][28] - **Awareness of Lipoprotein(a)**: There is an increasing awareness and understanding of Lipoprotein(a) as a risk factor among patients, which could enhance the market for obicetrapib [30][31] Safety and Efficacy - **Safety Profile**: The safety profile of obicetrapib is emphasized as a significant advantage, especially in a market where patients are increasingly concerned about drug safety [38][39] - **Combination Therapy Potential**: The drug's compatibility with other therapies is highlighted as a key factor for its future success [40] Future Studies and Data - **HORIZON Trial**: The HORIZON trial is expected to read out in the first half of 2026, potentially before the PREVAIL results, which could provide additional insights into the drug's efficacy [33][34] Additional Insights - **Market Dynamics**: The evolving landscape of patient expectations and the increasing focus on personalized medicine are shaping the approach to drug development and marketing strategies [26][27] - **Long-term Vision**: The company is committed to exploring various life cycle management options for obicetrapib, indicating a strategic focus on sustained market presence and adaptability [40]

Core Insights - The company has had a successful year in 2025, completing its BROADWAY Phase III trials, which are crucial for regulatory approval submissions globally [2] - Significant findings from the BROADWAY trial include a 21% reduction in major adverse cardiac events (MACE) among 2,500 patients, indicating a strong early signal of benefit [3] Company Developments - The completion of the BROADWAY Phase III trials positions the company favorably for future regulatory approvals [2] - Publications in prestigious journals such as the New England Journal of Medicine and JACC highlight the company's advancements in LDL lowering and drug tolerability [2] Clinical Outcomes - The BROADWAY trial demonstrated a relative risk reduction of 21% in MACE, which is a critical metric for assessing the drug's effectiveness [3] - The trial involved over 100 events, providing a robust dataset for analysis and understanding the early benefits of the drug [3]

NewAmsterdam Pharma Company (NasdaqGM:NAMS) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsMichael Davidson - CEOGeoff Meacham - Global Head of Biotech and Pharma ResearchIan Somaiya - CFOGeoff MeachamYeah, the Global Healthcare Conference at Citi. My name's Geoff Meacham. I am the head of healthcare, global head of biotech, pharma research. Fun, fun. We're thrilled today to have NewAmsterdam Pharma. So we have Michael Davidson, CEO. We have Ian Somaiya, CFO. Guys, thanks a lot for the ...

NewAmsterdam Pharma Company (NasdaqGM:NAMS) FY 2025 Conference December 03, 2025 03:15 PM ET Company ParticipantsJeff Meacham - Global Head of Biotech and Pharma ResearchMichael Davidson - CEOIan Somaiya - CFOJeff MeachamYeah, the Global Healthcare Conference at Citi. My name's Jeff Meacham. I am the head of healthcare, global head of biotech, pharma research. Fun, fun. We're thrilled today to have NewAmsterdam Pharma. So we have Michael Davidson, CEO. We have Ian Somaiya, CFO. Guys, thanks a lot for the ti ...

Financial Data and Key Metrics Changes - The company reported a significant reduction in major adverse cardiac events (MACE) by 21% in the BROADWAY trial, which included 2,500 patients, indicating strong efficacy of their drug [4][7] - The drug demonstrated a 50% reduction in Lp(a) levels, a key target for cardiovascular health, which is not addressed by statins [5][58] Business Line Data and Key Metrics Changes - The BROADWAY trial results have positioned the drug as a differentiated therapy in the lipid-lowering market, with additional benefits in diabetes risk reduction and potential Alzheimer's prevention [6][21] - The company is preparing for the PREVAIL study, which is expected to provide further validation of the drug's efficacy and safety [9][14] Market Data and Key Metrics Changes - The company anticipates a significant increase in the patient population needing aggressive LDL treatment due to new guidelines emerging from studies like VESALIUS, which showed mortality benefits from lowering LDL below 55 [54][55] - The partnership with Menarini is expected to enhance market access in Europe, leveraging their extensive sales force of 6,000 representatives [52][50] Company Strategy and Development Direction - The company aims to position its drug as the go-to option for patients requiring LDL lowering, emphasizing its unique benefits beyond traditional lipid-lowering therapies [56][57] - Future studies are planned to explore the drug's effects on Alzheimer's and diabetes, with a focus on expanding its therapeutic indications [76][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address unmet medical needs in cardiovascular health and Alzheimer's prevention, highlighting the growing recognition of its benefits in the medical community [8][20] - The company is committed to maintaining a strong adherence to study protocols in ongoing trials, which is crucial for regulatory approval and market success [9][13] Other Important Information - The company has published significant findings in reputable journals, enhancing its credibility and visibility in the medical community [50][19] - The management is exploring partnerships for funding large-scale studies to mitigate financial risks associated with drug development [31][34] Q&A Session Summary Question: What is the expected impact of the PREVAIL study on the drug's market potential? - Management indicated that the PREVAIL study is crucial for validating the drug's efficacy and will inform the timing of regulatory filings for U.S. approval [14][15] Question: How does the company plan to address skepticism regarding CETP inhibitors? - The management acknowledged the need to address skepticism and emphasized the importance of robust data from the BROADWAY trial to build confidence among healthcare providers [78][50] Question: What are the anticipated guidelines for LDL treatment following recent studies? - Management expects that new guidelines will significantly increase the number of patients requiring treatment, particularly those with atherosclerotic disease [54][55]

Summary of NewAmsterdam Pharma Company FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Focus**: Cholesterol-lowering therapies, specifically the drug obicetrapib Key Points Industry Context - The cholesterol-lowering market is significant, with approximately **30 million patients** in the U.S. diagnosed with hypercholesterolemia who are not achieving their LDL goals [21] - The market for lipid-lowering therapies is projected to be **$5 billion or higher** [63] Product Development and Regulatory Timeline - NewAmsterdam has completed three positive Phase III studies for obicetrapib, focusing on LDL reduction [9] - Regulatory filing in Europe has been accepted, with approval expected in **2026** [9] - The U.S. regulatory filing is dependent on the outcomes of the PREVAIL study, which is expected to provide data at the time of commercial launch [11][17] Competitive Landscape - NewAmsterdam positions obicetrapib as a unique CETP inhibitor, differentiating it from PCSK9 therapies [16] - Merck is also developing a PCSK9 therapy, with plans to file for approval in the first half of **2026** [44] - The company believes it can outperform Merck in market share due to the distinct advantages of obicetrapib [59] Clinical Data and Efficacy - Obicetrapib is expected to achieve **35%-40%** LDL reduction as a monotherapy and **50%-55%** in combination with ezetimibe [42] - The drug has shown a **15% reduction** in the rate of new-onset diabetes, which is a significant benefit for patients at risk [22] - The adverse event profile of obicetrapib is favorable, with lower rates of adverse events compared to placebo [43] Market Access and Pricing Strategy - The focus is on maximizing payer access at launch, with pricing strategies aligned with existing market frameworks [26] - The current pricing paradigm in the U.S. involves high list prices with lower net prices due to discounting [27] Future Opportunities - NewAmsterdam is exploring the potential of obicetrapib in treating Alzheimer's, with plans for a Phase IIB trial focusing on biomarkers related to Alzheimer's function [86] - The company aims to engage with the FDA to discuss the path forward for Alzheimer's treatment [88] Methodology and Data Reporting - NewAmsterdam uses the beta-quant method for LDL measurement, which is consistent with industry standards [82] - The company is aware of the variability in LDL measurement methods and aims to provide clarity in its data reporting [80] Conclusion - NewAmsterdam Pharma is positioned to enter the cholesterol-lowering market with a unique product that addresses significant unmet needs. The company is focused on regulatory approvals, competitive differentiation, and maximizing market access while exploring additional therapeutic areas such as Alzheimer's.

Core Insights - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C levels [1][3] - The company aims to address the unmet need for safe and well-tolerated LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Upcoming Investor Conferences - NewAmsterdam management will participate in the 8th Annual Evercore Healthcare Conference on December 2, 2025, with CFO Ian Somaiya speaking at 3:50 p.m. ET [4] - The company will also be present at Citi's 2025 Global Healthcare Conference on December 3, 2025, where CEO Michael Davidson and CFO Ian Somaiya will speak at 3:15 p.m. ET [4] - Additionally, NewAmsterdam will attend the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, with CEO Michael Davidson and CFO Ian Somaiya participating at 8:00 a.m. ET [4] Company Overview - NewAmsterdam Pharma is dedicated to improving patient care in populations with metabolic diseases where current therapies are insufficient or poorly tolerated [3] - The company is conducting multiple phase 3 trials for obicetrapib, an oral, low-dose CETP inhibitor, which is being tested alone and in combination with ezetimibe as an adjunct to statin therapy [3]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM: NAMS) - **Key Molecule**: Obicetrapib - **Conference Date**: November 19, 2025 Core Industry Insights - **Clinical Trials**: NewAmsterdam has successfully completed three phase 3 trials, which bolster confidence in the upcoming EMA application for obicetrapib approval in 2026 [4][6] - **Market Positioning**: The company aims to establish a global brand for obicetrapib, emphasizing its benefits beyond just LDL reduction, including increasing HDL and reducing small particle LDL [5][6] Key Points on Obicetrapib - **Clinical Efficacy**: A previous phase 3 trial (Broadway) demonstrated a 21% reduction in major adverse cardiovascular events (MACE), which is expected to translate positively in the PREVAIL trial [8][10] - **Trial Design**: The PREVAIL trial is designed to avoid past mistakes, being longer and targeting high-risk patients, which enhances confidence in its outcomes [8][10] - **Regulatory Strategy**: NewAmsterdam plans to have outcomes data available at the time of launch, a unique position in the lipid-lowering space [16][17] Competitive Landscape - **Comparison with PCSK9 Inhibitors**: NewAmsterdam's obicetrapib is positioned against oral PCSK9 inhibitors, with the expectation that oral administration will increase patient adherence compared to injections [40][41] - **Market Expansion**: The company believes that the market for lipid-lowering drugs is expanding, with a significant number of patients not currently at treatment goals [43] Additional Insights - **Alzheimer's Disease**: There is potential for obicetrapib to impact Alzheimer's disease biomarkers, indicating a broader therapeutic profile compared to traditional statins [25][41] - **Patient Population**: The target population for obicetrapib includes a large number of patients with diabetes or prediabetes, which is a significant market opportunity [41][43] - **Clinical Goals**: The focus is on achieving treatment goals rather than just numerical reductions in LDL, with a reported goal attainment of 70-80% in clinical trials [30][41] Conclusion - NewAmsterdam Pharma is strategically positioned with obicetrapib, focusing on comprehensive cardiovascular benefits and a robust regulatory strategy, while navigating a competitive landscape that includes oral PCSK9 inhibitors. The company is optimistic about its upcoming trials and market potential, particularly in addressing unmet needs in lipid management and related comorbidities.

Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1]. Group 2: Analyst Background - The author, Terry Chrisomalis, is a private investor with a background in Applied Science, focusing on generating long-term value in the healthcare sector [2]. - The service aims to assist healthcare investors in making informed decisions through comprehensive analysis and news reports [2].

Summary of NewAmsterdam Pharma Company Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Event**: 2025 Conference on November 12, 2025 - **Key Speakers**: CEO Michael Davidson, CFO Ian Somaiya Industry Insights - **Industry**: Lipid management and cardiovascular health - **Recent Event**: Discussion of the Freselius trial presented at the American Heart Association (AHA) conference, highlighting significant advancements in lipid treatment guidelines Core Points and Arguments 1. **Freselius Trial Results**: - Reported a 25% reduction in three-point MACE and a mortality benefit, which is a significant improvement over the previous FOURIER trial that showed only a 15% relative risk reduction without mortality benefit [2][3] - The trial's findings are expected to broaden the population guidelines for LDL cholesterol management, suggesting targets below 55 mg/dL, potentially even 40 mg/dL [3][4] 2. **PREVAIL Trial Design**: - The PREVAIL trial is designed to run longer (4.6 years) to capture adequate event data, similar to the successful approach of the Freselius trial [4][5] - The trial aims to validate the LDL-lowering benefits and their correlation with reduced myocardial infarction rates [5] 3. **Market Expansion**: - The new guidelines will effectively double the market for LDL-lowering treatments, as they will include patients with atherosclerotic disease regardless of prior heart attacks or strokes [9] 4. **Oral PCSK9 Developments**: - Merck's oral PCSK9 treatment shows promise but has limitations similar to Rybelsus, which may affect patient adherence [11][12] - NewAmsterdam believes its fixed-dose combination (FDC) will achieve better LDL lowering with easier administration [12] 5. **BROADWAY Trial Outcomes**: - NewAmsterdam's BROADWAY trial demonstrated a 21% MACE benefit, suggesting that their drug offers additional benefits beyond LDL lowering [14][24] - The company is optimistic about matching or exceeding this benefit in the PREVAIL trial [24] 6. **Regulatory Strategy**: - NewAmsterdam plans to engage with the FDA regarding the timing of filing for PREVAIL outcomes data, which could be included in the product label [19] - The European filing by partner Menarini has been accepted, with expected approval in the second half of next year [19] 7. **LPL-A and Alzheimer's Research**: - The company is exploring the potential of obicetrapib in treating Alzheimer's, particularly in high-risk populations [47][48] - There is significant interest from the Alzheimer's community regarding the drug's potential benefits [48] 8. **Market Opportunity**: - The lipid market is substantial, with 30 million individuals in the U.S. diagnosed with hypercholesterolemia, many not at treatment goals [42] - NewAmsterdam estimates an $8 billion market opportunity for its drug, supported by the ability to treat a wide range of patients with elevated LDL and LPL-A [42][43] 9. **Competitive Landscape**: - The company acknowledges the presence of other PCSK9 therapies but believes its product offers superior benefits and ease of use [16][45] - The evolving landscape of lipid treatments, including oral options, is expected to expand the overall market rather than cannibalize existing products [45] Additional Important Insights - **Patient Compliance**: NewAmsterdam is actively monitoring trial execution metrics and ensuring high patient compliance through site visits and support [37][39] - **Future Directions**: The company is committed to launching obicetrapib independently to maximize value and is optimistic about its strategic position in the lipid space [51]