NewAmsterdam Pharma Co N.V. - Q1 2026 Filing Summary
Business Context and Reporting Period
This Form 10-Q covers the quarterly period ended March 31, 2026. NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing obicetrapib, an oral CETP inhibitor for lowering LDL-C in patients with cardiovascular disease. The company operates as a single segment and relies on a strategic partnership with Menarini for commercialization in Europe while pursuing U.S. commercialization independently.
Key Financial Metrics
| Metric (in thousands USD) | Q1 2026 | Q1 2025 |
|---|---|---|
| Revenue | $3,040 | $2,978 |
| Net Loss | $(48,441) | $(39,527) |
| Operating Loss | $(58,420) | $(68,925) |
| Net Cash Used in Operating Activities | $(30,604) | $(36,468) |
| Cash, Cash Equivalents & Marketable Securities | $707,345 | $748,420 |
| Derivative Warrant Liabilities | $50,229 | $57,272 |
Note: Revenue in Q1 2026 is derived from the Menarini Supply Agreement, whereas Q1 2025 revenue was primarily from the recognition of deferred R&D performance obligations.
Material Changes vs. Prior Period
- Operating Expenses: Total operating expenses decreased by $10.4 million (15%) to $61.5 million. This was driven by an $8.3 million reduction in clinical expenses due to the completion of Phase 3 trials in 2025 and a $2.9 million decrease in non-clinical expenses.
- Revenue Composition: Revenue shifted from license-related deferred revenue recognition in 2025 to supply revenue under the Menarini Supply Agreement in 2026.
- Non-Operating Items: The company recorded a $5.9 million gain from the fair value change of warrants, down from a $13.8 million gain in the prior year. The earnout liability was settled in 2025, resulting in no earnout gain in 2026.
- Foreign Exchange: The company incurred a $1.6 million foreign exchange loss in Q1 2026, compared to a $4.3 million gain in Q1 2025, primarily due to Euro fluctuations.
Outlook, Risks, and Management Commentary
- Clinical Progress: The company completed enrollment in the PREVAIL Phase 3 cardiovascular outcomes trial (CVOT) in April 2024. An interim analysis is planned for Q4 2026, with results expected in Q1 2027. The company also completed enrollment in the REMBRANDT trial (assessing coronary plaque) in March 2026.
- Regulatory Status: Marketing Authorization Applications (MAAs) for obicetrapib monotherapy and fixed-dose combination were accepted for review by the EMA, UK, and Switzerland in August 2025. Decisions are anticipated in the second half of 2026.
- Liquidity: With approximately $707 million in cash and marketable securities, management believes the company has sufficient liquidity to fund operations and obligations for the foreseeable future.
- Risks: Key risks include the uncertainty of the PREVAIL interim analysis, potential changes in healthcare legislation (e.g., U.S. IRA price negotiations, EU regulatory reforms), and the possibility that warrant holders may not exercise their options if the share price remains below the $11.50 exercise price.
Investor Verification Checklist
- PREVAIL Trial Data: Verify the timing and criteria for the Q4 2026 interim analysis and the potential impact of the observed MACE event rates on trial continuation.
- European Approval Timeline: Confirm the status of the EMA, UK, and Swiss regulatory reviews and the projected launch date in Q4 2026.
- Warrant Liability Valuation: Review the shift in valuation methodology from market price to the Black-Scholes model due to low trading volume and its impact on reported earnings.
- Supply Agreement Economics: Assess the revenue recognition model under the Menarini Supply Agreement, which is based on a markup of cost of goods sold.
- Capital Requirements: Evaluate the company's burn rate against its $707 million cash position to determine runway without additional financing.