NAMS

Business Context and Reporting Period

NewAmsterdam Pharma Company N.V. (NAMS) is a late-stage biopharmaceutical company focused on developing obicetrapib, an oral cholesteryl ester transfer protein (CETP) inhibitor for lowering LDL-C in patients with cardiometabolic diseases. The company also explores obicetrapib for Alzheimer's disease. This 10-K covers the fiscal year ended December 31, 2025. The company is incorporated in the Netherlands and trades on the Nasdaq Global Market.

Key Financial Metrics

Note: The filing does not provide specific gross margin or operating margin percentages due to the pre-commercial nature of the business.

Material Changes vs. Prior Period

• Revenue Decline: Revenue decreased 50.6% to $22.5 million, primarily due to the absence of a $27.3 million clinical development milestone payment recognized in 2024. This was partially offset by the recognition of development cost contributions from the Menarini License.
• Expense Shifts: R&D expenses decreased 6.3% to $141.8 million, driven by a $30.5 million reduction in clinical expenses following the completion of several Phase 3 trials in late 2024. Conversely, SG&A expenses increased 51.0% to $106.4 million, largely due to a $28.2 million increase in personnel expenses (including $19.5 million in share-based compensation) and marketing startup costs.
• Net Loss Improvement: The net loss narrowed by $37.8 million year-over-year, despite higher operating expenses, due to a $41.0 million swing in fair value changes (a $4.0 million gain on earnout settlement in 2025 vs. a $37.0 million loss in 2024) and a $19.7 million improvement in foreign exchange results.
• Liquidity: Cash and marketable securities decreased by approximately $105 million, reflecting operating cash outflows of $147.8 million and investing outflows of $174.9 million (primarily purchases of marketable securities), partially offset by financing inflows of $29.5 million.

Guidance, Outlook, and Risks

• Regulatory Milestones: In August 2025, the European Medicines Agency (EMA) accepted Marketing Authorization Applications (MAAs) for obicetrapib monotherapy and fixed-dose combination (FDC) with ezetimibe, submitted by partner Menarini. Decisions are anticipated in the second half of 2026. The company plans to submit a New Drug Application (NDA) in the U.S. shortly after the European submission.
• Clinical Progress: The Phase 3 PREVAIL cardiovascular outcomes trial (CVOT) completed enrollment in April 2024. The trial is expected to conclude no earlier than the end of 2026, contingent on the occurrence of target Major Adverse Cardiovascular Events (MACE). Positive biomarker data for Alzheimer's disease was announced in July 2025, with a new clinical trial planned for 2026.
• Capital Requirements: Management believes current cash resources ($728.9 million) are sufficient to fund operations for at least the next 12 months. The company anticipates continuing to incur significant losses until regulatory approval and commercialization are achieved.
• Key Risks:
  • Regulatory Approval: Failure to obtain FDA or EMA approval for obicetrapib would materially harm the business.
  • Capital Needs: Substantial additional financing may be required to complete development and commercialization; failure to secure this could force delays or termination of programs.
  • Collaboration Dependence: Commercialization in Europe relies on Menarini; failure of Menarini to fulfill obligations could impact European prospects.
  • Competition: Intense competition from existing therapies (PCSK9 inhibitors, ezetimibe) and emerging oral PCSK9 inhibitors.

Investor Verification Checklist

• Cash Runway: Verify the sufficiency of the $728.9 million cash balance against projected burn rates for the PREVAIL CVOT and potential U.S. commercialization build-out.
• Menarini Partnership: Confirm the status of the EMA review process and Menarini's commitment to commercialization efforts in the European territory.
• PREVAIL Trial Timeline: Monitor the accrual of MACE events in the PREVAIL trial, as the trial duration is event-driven and could extend beyond the initial 2026 estimate.
• Revenue Recognition: Understand the variability of revenue streams, which are currently dependent on milestone achievements and development cost reimbursements rather than product sales.
• Intellectual Property: Review the patent portfolio expiration dates, particularly the "Third Generation" patents extending into the 2040s, to assess long-term exclusivity.