Financial Data and Key Metrics Changes - The company reported a significant milestone in 2025, completing three phase 3 trials for regulatory approval, with a notable 21% reduction in major adverse cardiac events (MACE) in the BROADWAY trial involving 2,500 patients [3][4][6] - The drug obicetrapib demonstrated a 50% reduction in Lp(a) levels, which is a significant differentiator from other lipid-lowering therapies [4][6] Business Line Data and Key Metrics Changes - The BROADWAY trial results highlighted the drug's efficacy in lowering LDL cholesterol by approximately 40%, with a combination with ezetimibe achieving a 50% reduction [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 market for LDL-lowering therapies due to new guidelines that recommend more aggressive treatment for patients with atherosclerotic disease [56] - The partnership with Menarini, which has a large sales force in Europe, is expected to enhance market penetration and distribution capabilities [53][51] Company Strategy and Development Direction - The company aims to position obicetrapib as the go-to oral agent for lowering Lp(a) and LDL cholesterol, emphasizing its safety and tolerability [59][61] - Future studies, including a phase 2B trial focusing on Alzheimer's prevention, are planned to further validate the drug's benefits [29][78] 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 approval and market entry [8][12] - The company is optimistic about the potential for obicetrapib to address unmet medical needs in cardiovascular and Alzheimer's disease prevention [7][19] Other Important Information - The company has published significant findings in reputable journals, which have positively influenced the medical community's perception of obicetrapib [51][50] - Management highlighted the importance of economic outcomes in supporting payer arguments for the drug's value [76][70] 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 the company believes peak sales potential could exceed $8 billion, primarily driven by cardiovascular benefits [42][49] Question: How does the company plan to address skepticism regarding CETP inhibitors? - Management acknowledged the need for robust data from the PREVAIL trial to alleviate concerns and emphasized the positive results from the BROADWAY trial as a foundation for confidence [81][80] Question: What are the implications of new treatment guidelines for LDL-lowering therapies? - Management noted that new guidelines could significantly expand the patient population requiring treatment, emphasizing the need for effective therapies like obicetrapib [56][57]

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]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Event**: FY Conference on November 11, 2025 Key Industry Insights - **Lipid Management**: The conference highlighted significant advancements in lipid management, particularly in the context of cardiovascular disease prevention. The recent American Heart Association (AHA) meeting emphasized the importance of LDL lowering and its correlation with mortality benefits, which is expected to shift treatment guidelines towards more aggressive LDL targets [6][54]. Core Points Discussed 1. **Mortality Benefit Evidence**: New studies have shown that aggressive LDL lowering can lead to mortality benefits, particularly in broader high-risk populations, which opens up new market opportunities for NewAmsterdam's products [6][54]. 2. **Prevail Study Design**: The Prevail study is designed to track event rates similar to previous successful studies, with a focus on achieving a significant reduction in cardiovascular events. The company is confident in the study's design and its potential outcomes [20][21][12]. 3. **Market Competition**: The competitive landscape includes Merck's oral PCSK9 inhibitor, which has shown promising LDL lowering results. However, NewAmsterdam believes its product, Obsettra, offers unique benefits, including Lp(a) lowering and potential Alzheimer's disease benefits, which could differentiate it in the market [13][15][47]. 4. **Regulatory Strategy**: NewAmsterdam plans to align its NDA submission with the completion of the Prevail study to ensure that the most relevant data is available at launch. The timing of the NDA submission is contingent on event tracking and FDA feedback [41][42][43]. 5. **Future Studies**: Additional studies, including Rubin and Rembrandt, are planned to further explore the drug's benefits in specific populations, particularly those with high Lp(a) levels and diabetes [44][45]. Additional Important Insights - **Market Growth Potential**: Analysts predict a significant market growth for lipid-lowering therapies, estimating a market size of $4 billion to $5 billion for both Merck and AstraZeneca, which NewAmsterdam aims to capture with its innovative approach [15][16]. - **Patient Compliance Concerns**: The discussion highlighted the challenges of patient compliance in real-world settings compared to clinical trials, which may affect the uptake of new therapies [13][14]. - **Emerging Technologies**: The future of lipid management is expected to be transformed by new technologies and therapies, including gene editing approaches, which could significantly impact cardiovascular disease prevention [54]. Conclusion NewAmsterdam Pharma is positioned to capitalize on the evolving landscape of lipid management with its upcoming product, Obsettra. The company is focused on leveraging new evidence supporting aggressive LDL lowering, maintaining a strategic approach to regulatory submissions, and preparing for a competitive market environment. The insights from the AHA meeting and ongoing studies will play a crucial role in shaping the company's future trajectory in the healthcare sector.

Core Insights - NewAmsterdam Pharma Company N.V. reported a quarterly loss of $0.41 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and a significant increase from a loss of $0.18 per share a year ago [1] - The company's revenues for the quarter ended September 2025 were $0.35 million, missing the Zacks Consensus Estimate by 91.03%, and a sharp decline from $29.11 million in the same quarter last year [2] - The stock has increased approximately 42.1% since the beginning of the year, outperforming the S&P 500's gain of 15.1% [3] Earnings Outlook - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$0.40 on revenues of $9.96 million, and for the current fiscal year, it is -$1.30 on revenues of $27.64 million [7] Industry Context - The Medical - Drugs industry, to which NewAmsterdam Pharma belongs, is currently ranked in the top 40% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]

Revenue and Financial Performance - The company has not generated significant revenue from pharmaceutical product sales, primarily relying on a non-refundable upfront amount of $120.9 million (€115.0 million) from the Menarini License[78]. - Revenue for the three months ended September 30, 2025 was $0.3 million, a decrease of $28.8 million or 99% compared to $29.1 million for the same period in 2024, primarily due to the absence of clinical milestones earned in 2025[94]. - For the nine months ended September 30, 2025, revenue was $22.5 million, a decrease of $10.3 million or 31% compared to $32.8 million for the same period in 2024[106]. - The company recognizes revenue from the sale of obicetrapib tablets and active pharmaceutical ingredients, with revenue recognized upon the transfer of control to Menarini[82]. - The December 2024 Offering generated net proceeds of $453.4 million after deducting underwriting discounts and commissions, enhancing the company's capital resources[118]. - The company completed a public offering of 5,871,909 Ordinary Shares at a price of $19.00 per share, generating net proceeds of $190.0 million after expenses[119]. - The company entered into a sales agreement allowing for the issuance of up to $250 million of Ordinary Shares, with no sales made under this agreement during the nine months ended September 30, 2025[120]. Expenses and Losses - Research and development expenses are expected to be significant as the company advances product candidates through clinical trials and pursues regulatory approval[86]. - Research and development expenses decreased by $4.7 million or 13% to $31.0 million for the three months ended September 30, 2025, driven by a $6.6 million decrease in clinical expenses due to the completion of several Phase 3 trials[95][97]. - Selling, general and administrative expenses increased by $6.1 million or 33% to $24.5 million for the three months ended September 30, 2025, primarily due to a $6.3 million increase in personnel expenses[98]. - Loss for the period was $72.0 million for the three months ended September 30, 2025, an increase of $55.4 million compared to a loss of $16.6 million for the same period in 2024[103]. - Total operating expenses for the nine months ended September 30, 2025 were $182.2 million, an increase of $16.3 million compared to $165.9 million for the same period in 2024[105]. - The company incurred an accumulated loss of $687.5 million as of September 30, 2025, and expects to continue incurring significant losses in the foreseeable future[116]. Cash and Liquidity - Cash, cash equivalents, and marketable securities as of September 30, 2025 totaled $756.0 million, providing liquidity for ongoing operations[117]. - The company had cash and cash equivalents of $538.4 million as of September 30, 2025, sufficient to meet estimated obligations of $27.9 million due within one year[130]. - Net cash used in operating activities decreased to $106.9 million for the nine months ended September 30, 2025, from $121.1 million in the same period of 2024[126]. - Net cash used in investing activities increased significantly to $153.8 million in the nine months ended September 30, 2025, primarily due to investments in marketable securities[128]. - Net cash provided by financing activities decreased to $15.8 million for the nine months ended September 30, 2025, compared to $202.9 million in the same period of 2024[129]. Clinical Trials and Product Development - The Phase 3 BROADWAY trial showed a 21% reduction in major adverse cardiovascular events (MACE) endpoint, with ongoing Phase 3 cardiovascular outcomes trial (PREVAIL) expected to conclude by the end of 2026[68]. - Obicetrapib demonstrated statistically significant LDL-C reductions in multiple Phase 3 trials, meeting primary and secondary endpoints[67]. - Approximately 30 million patients in the U.S. do not achieve risk-based LDL-C goals despite lipid-lowering therapy, highlighting a significant market opportunity[72]. - The company aims to develop an LDL-C lowering monotherapy and a fixed-dose combination therapy to address unmet needs in patients with elevated LDL-C[73]. - The company has observed obicetrapib to be well tolerated in over 3,500 patients, with side effects similar in frequency and severity to placebo[67]. Partnerships and Agreements - The company has partnered with Menarini for the commercialization of obicetrapib in Europe, with marketing authorization applications validated by the European Medicines Agency[75]. - The Menarini Supply Agreement includes provisions for the transfer of manufacturing and establishes the company as Menarini's exclusive supplier of obicetrapib products[76]. - Under the Menarini License, the company received a non-refundable upfront payment of €115 million and is eligible for up to €863 million in milestone payments[121][122]. - As of September 30, 2025, the company received €30.0 million in milestone payments and €13.8 million in R&D reimbursements from Menarini[123]. Financial Instruments and Risks - The fair value of derivative warrant liabilities was $44.4 million as of September 30, 2025, with a 1% change in market price affecting the liability by $0.4 million[141]. - The company's exposure to foreign currency risk was $112.8 million as of September 30, 2025, with a potential earnings impact of approximately $1.1 million from a hypothetical 1% change in exchange rates[139].