UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number 001-41562 NewAmsterdam Pharma Company N.V. (Exact Name of Registrant as Specified in Its Charter) The Netherlands N/A (State or Other Jurisdiction ...

Financial Position - As of December 31, 2025, NewAmsterdam Pharma Company reported a cash, cash equivalents, and marketable securities balance of approximately $729 million[8] - The report does not include any financial statements or exhibits beyond the press release[11] Company Overview - The company is registered under the Commission File Number 001-41562 and trades on The Nasdaq Stock Market LLC under the symbol NAMS[5] - NewAmsterdam Pharma is classified as an emerging growth company under the Securities Act of 1933[5] - The company has not indicated any changes in its name or address since the last report[2] Strategic Priorities - The company highlighted its achievements for 2025 and outlined strategic priorities for 2026 in a press release issued on January 9, 2026[8] Compliance and Reporting - The company has not elected to use the extended transition period for complying with new or revised financial accounting standards[6] - The information provided in the report is not deemed "filed" for purposes of the Securities Exchange Act of 1934[10] - The Chief Financial Officer, Ian Somaiya, signed the report on January 9, 2026[15] - The press release is furnished as Exhibit 99.1 to the Current Report on Form 8-K[8]

Core Insights - NewAmsterdam Pharma is advancing its clinical and regulatory efforts for obicetrapib, with expected approval decisions from EMA, UK, and Switzerland regulators in the second half of 2026 [1][2] - The company reported a cash position of $728.9 million as of December 31, 2025, indicating financial strength to support ongoing operations and potential commercial launch [1][2] Clinical Development and Regulatory Updates - NewAmsterdam is developing obicetrapib as a low-dose, oral CETP inhibitor for patients at risk of cardiovascular disease (CVD) [3][10] - Marketing Authorization Applications (MAAs) for obicetrapib and its fixed-dose combination with ezetimibe have been accepted for review by EMA, UK, and Switzerland [2][3] - The company is preparing for a potential commercial launch in Europe alongside its partner Menarini [2][3] - Ongoing Phase 3 trials include PREVAIL, REMBRANDT, and RUBENS, with topline data from RUBENS expected by year-end 2026 [2][8] Financial Performance - NewAmsterdam reported a revenue of $22.5 million for the year ended December 31, 2025, a decrease from $45.6 million in 2024 [6][21] - Research and Development (R&D) expenses were $141.8 million in 2025, down from $151.4 million in 2024, primarily due to the completion of several Phase 3 trials [9][21] - Selling, General and Administrative (SG&A) expenses increased to $106.4 million in 2025 from $70.4 million in 2024, driven by higher personnel and marketing costs [13][21] Alzheimer's Disease Analysis - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key Alzheimer's disease biomarker, supporting a link between CETP inhibition and neurodegeneration [7][12] - The analysis included 1,535 patients, with notable results in ApoE4 carriers, showing a 20.5% reduction in p-tau217 levels over 12 months compared to placebo [7][12][14] Upcoming Milestones - NewAmsterdam plans to announce additional data from its ongoing Phase 3 trials in 2026, including the potential initiation of a new clinical trial for obicetrapib in early Alzheimer's disease patients [5][8]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM: NAMS) - **Event**: 2026 Emerging Outlook Biotech Summit - **Date**: February 11, 2026 Key Points Industry and Product Focus - NewAmsterdam Pharma is focused on the development of obicetrapib, a CETP inhibitor aimed at treating hyperlipidemia and associated cardiovascular risks [1][2] Clinical Trials and Study Updates - **PREVAIL Study**: Expected mid-year update on the study's readout timelines, with a commitment to provide updates based on event adjudication over two years [7][8] - **BROADWAY Study**: Demonstrated a 21% MACE (Major Adverse Cardiac Events) benefit, with event rates tracking in line with PREVAIL [7][8] - **Compliance Tracking**: Emphasis on patient compliance due to the long duration of outcome studies, with strategies in place to maintain patient engagement [16][17] Drug Efficacy and Safety - Obicetrapib shows the ability to achieve risk-based goals in 70%-80% of patients, with a convenient dosing regimen of a 10-mg oral pill [22] - The drug has demonstrated a reduction in Lp(a) levels by upwards of 50% and has potential implications for diabetes and Alzheimer's disease [23][52] - The safety profile is favorable, with lower adverse events compared to placebo, enhancing patient retention in studies [17][18] Market Opportunity - There are approximately 30 million patients in the U.S. not achieving risk-based goals despite being on treatment for hyperlipidemia, indicating a significant market opportunity [24][52] - The commercial landscape is expected to evolve positively, with NewAmsterdam positioned to leverage its differentiated drug profile against competitors [51][72] Competitive Landscape - NewAmsterdam is the only company with a CETP inhibitor in development, with expectations for regulatory approval in Europe and the U.S. [51][76] - The company plans to differentiate obicetrapib by emphasizing its broader benefits beyond LDL-C reduction, targeting various patient populations including those with diabetes and elevated Lp(a) levels [52][76] Regulatory and Launch Strategy - The U.S. filing is contingent on having outcomes data available at launch, while the European filing has already occurred [76] - The company is confident in its ability to launch successfully, drawing on the experience of its commercial team [70][72] Future Studies and Insights - Ongoing studies (VINCENT, RUBENS, REMBRANDT) will further explore the drug's efficacy, particularly regarding small LDL particle elimination [31][34] - The HORIZON study will provide insights into the contribution of Lp(a) to MACE benefits observed in BROADWAY, which may inform expectations for PREVAIL [79] Additional Insights - The design of the PREVAIL study is intended to avoid the pitfalls of previous CETP inhibitors, focusing on LDL reduction rather than HDL elevation [43][44] - The company has a strong leadership team with extensive experience in cardiology and lipidology, which is expected to enhance the study's execution and outcomes [42][43] This summary encapsulates the critical aspects of NewAmsterdam Pharma's conference call, highlighting the company's strategic focus, clinical developments, market opportunities, and competitive positioning within the biotech industry.

Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1] Company Overview - NewAmsterdam Pharma aims to improve patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials as a LDL-C lowering therapy [3] - Obicetrapib is being studied both alone and in fixed-dose combinations with ezetimibe, intended as an adjunct to statin therapy for patients with elevated LDL-C [3]

Core Insights - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, an oral CETP inhibitor, with EMA approval expected in the second half of 2026 [1][3][5] - The company is conducting multiple Phase 3 trials, including PREVAIL, REMBRANDT, and RUBENS, to evaluate the efficacy of obicetrapib in various patient populations [3][6] - NewAmsterdam reported a year-end cash balance of approximately $729 million, which is expected to support operations through anticipated clinical milestones [7] Clinical Development - Obicetrapib is being developed as a low-dose, once-daily therapy for patients with elevated LDL-C who are at risk of cardiovascular disease [2][12] - The PREVAIL trial is tracking overall MACE event rates in line with the BROADWAY trial, indicating promising results for cardiovascular outcomes [3][4] - The RUBENS trial has enrolled its first patients and aims to evaluate obicetrapib in patients with metabolic syndrome [1][3] Regulatory and Commercialization Plans - NewAmsterdam is preparing for a potential commercial launch in Europe, contingent upon EMA approval for obicetrapib and its fixed-dose combination with ezetimibe [3][5] - The company has submitted marketing authorization applications (MAAs) for both obicetrapib monotherapy and the fixed-dose combination [5] Financial Position - As of December 31, 2025, NewAmsterdam's cash, cash equivalents, and marketable securities balance is approximately $729 million, which is projected to be sufficient for ongoing operations and potential commercialization [7] Alzheimer's Disease Research - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key biomarker for Alzheimer's disease, suggesting a link between CETP inhibition and neurodegeneration [4][11] - NewAmsterdam plans to initiate a dedicated Alzheimer's trial in 2026 based on encouraging biomarker analysis results [3][6]

Core Insights - TimesSquare Capital Management's "U.S. Small Cap Growth Strategy" reported a gross return of 2.26% and a net return of 2.01% for Q3 2025, significantly underperforming the Russell 2000 Growth Index, which returned 12.19% [1] - The fund's top five holdings were highlighted, indicating its best investment picks for 2025 [1] Company Analysis - NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) is a late-stage biopharmaceutical firm focused on cholesterol inhibitors for cardiovascular diseases [3] - The stock of NewAmsterdam Pharma experienced a one-month decline of 3.79% but has gained 28.57% over the past 52 weeks, closing at $33.48 per share with a market capitalization of $3.796 billion as of January 5, 2026 [2] - NewAmsterdam's lead candidate, a CETP inhibitor, demonstrated significant LDL level reductions without adverse side effects, contributing to a 57% increase in its share price [3] Investment Sentiment - NewAmsterdam Pharma was held by 28 hedge fund portfolios at the end of Q3 2025, a decrease from 31 in the previous quarter, indicating a slight decline in popularity among hedge funds [4] - Despite the potential of NewAmsterdam as an investment, the company is viewed as having less upside compared to certain AI stocks, which are considered to carry less downside risk [4]

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]

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]