NewAmsterdam Pharma Co N.V. - 10-Q Summary (Q2 2026)
Business Context and Reporting Period
NewAmsterdam Pharma Company N.V. is a late-stage biopharmaceutical company focused on developing obicetrapib, an oral CETP inhibitor for lowering LDL-C. The reporting period covers the quarter and six months ended June 30, 2026. The Company is preparing for potential commercialization in Europe via its partner Menarini and continues development in the U.S. and other regions.
Key Financial Metrics
| Metric (in thousands USD) | Q2 2026 | Q2 2025 | 6M 2026 | 6M 2025 |
|---|---|---|---|---|
| Revenue | $3,701 | $19,145 | $6,741 | $22,123 |
| Net Loss | $(64,135) | $(17,364) | $(112,576) | $(56,891) |
| Operating Loss | $(64,864) | $(35,635) | $(123,284) | $(104,560) |
| R&D Expenses | $41,673 | $27,516 | $79,682 | $72,267 |
| SG&A Expenses | $26,892 | $27,264 | $50,343 | $54,416 |
| Cash & Equivalents | $424,151 | N/A | N/A | N/A |
| Total Liquidity (Cash + Securities) | $678,264 | N/A | N/A | N/A |
| Derivative Warrant Liability | $54,452 | N/A | N/A | N/A |
Note: Revenue consists entirely of supply revenue from Menarini in 2026. 2025 revenue included significant license milestone recognition.
Material Changes vs. Prior Period
- Revenue Decline: Revenue dropped 81% in Q2 and 70% in the first six months compared to 2025. This is primarily due to the non-recurrence of $16.1 million in development cost contribution revenue recognized in the prior year under the Menarini License.
- Increased R&D Spend: R&D expenses increased by 52% in Q2 and 10% in the six-month period. Drivers include the initiation of new clinical trials (REMBRANDT, RUBENS), progression of ongoing trials, and reclassification of medical affairs personnel costs from SG&A to R&D.
- Warrant Liability Volatility: The Company changed its valuation method for Public Warrants from market price to a Black-Scholes model due to low trading volume. This resulted in a $4.6 million loss in Q2 2026 compared to a $2.6 million gain in Q2 2025.
- Foreign Exchange: The Company recorded a $0.5 million FX loss in Q2 2026, contrasting with an $8.6 million gain in the prior year, driven by Euro exchange rate movements.
Outlook, Risks, and Management Commentary
- Regulatory Milestones: The EMA's CHMP adopted a positive opinion in July 2026 for obicetrapib monotherapy and fixed-dose combination (FDC). Menarini expects regulatory decisions in the second half of 2026, with potential launches in Germany and the UK in Q4 2026.
- Clinical Trials: The PREVAIL cardiovascular outcomes trial (CVOT) will undergo an interim analysis in Q4 2026. Preliminary blinded data showed a Year 1 MACE event rate consistent with the BROADWAY trial. The DSMB will recommend whether to stop early for efficacy/futility or continue to the end of 2027.
- Liquidity: As of June 30, 2026, the Company held $678.3 million in cash, cash equivalents, and marketable securities. Management believes this is sufficient to fund operations and contractual obligations for the foreseeable future.
- Risks: Key risks include the outcome of the PREVAIL interim analysis, potential delays in regulatory approvals, and the impact of U.S. healthcare legislation (IRA, MFN pricing models) and EU pharmaceutical reforms on future pricing and reimbursement.
Investor Verification Checklist
- PREVAIL Trial Data: Verify the timing and results of the Q4 2026 interim analysis for the PREVAIL CVOT, as this is critical for U.S. regulatory approval.
- European Launch Timeline: Confirm Menarini's actual launch dates in Germany and the UK following the expected H2 2026 regulatory decisions.
- Supply Agreement Economics: Review the specific markup structure and volume forecasts in the Menarini Supply Agreement to assess future revenue sustainability.
- Warrant Exercise Probability: Monitor the trading price of Ordinary Shares relative to the $11.50 warrant exercise price to assess the likelihood of cash proceeds from warrant exercises.
- Regulatory Policy Impact: Assess the potential impact of the "One Big Beautiful Bill Act" and EU pharmaceutical framework changes on pricing power and market access.