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]

-- Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 -- -- Phase 3 PREVAIL CVOT blinded event rate tracking in line with observed event rate in BROADWAY--         -- Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 -- -- $728.9 million in cash, cash equivalents and marketable securities at December 31, 2025 -- NAARDEN, the Netherlands and MIAMI, ...

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 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]