NewAmsterdam Pharma Company N.V. reported its third‑quarter 2025 results on November 5, 2025, showing a cash balance of $756.0 million at September 30, 2025 and a net loss of $72.0 million. The company posted a loss of $0.41 per share, missing the consensus estimate of a $0.38 loss, while revenue fell sharply to $0.30 million from $29.1 million in Q3 2024, a decline driven almost entirely by the absence of milestone payments that had been received in the prior year.
The revenue miss reflects the fact that NewAmsterdam’s only source of cash flow in the quarter was a $29.1 million milestone payment from a previous partnership, and no new milestone or product sales were recorded. The company’s operating expenses rose to $72.0 million, largely due to higher personnel costs, share‑based compensation, and a $4.5 million non‑cash derivative loss, which widened the net loss relative to the prior year’s $20.5 million loss. These cost increases, combined with the lack of milestone revenue, explain why the EPS fell below expectations.
Regulatory progress remained a bright spot. The European Medicines Agency accepted the company’s marketing authorization applications for obicetrapib monotherapy and the fixed‑dose combination with ezetimibe, a key step toward a potential European launch. The company reiterated its partnership with Menarini, which could deliver up to €863 million in milestone payments and double‑digit royalties, underscoring the strategic value of the European commercialization agreement.
Clinical data presented at the same event highlighted pooled major adverse cardiovascular event (MACE) results from the BROADWAY, BROOKLYN, and TANDEM trials, and a pre‑specified Alzheimer’s disease biomarker substudy that showed significant reductions in plasma p‑tau217, particularly in ApoE4 carriers. These findings support the dual therapeutic potential of obicetrapib for cardiovascular disease and early Alzheimer’s disease.
Management emphasized the importance of the EMA acceptance and the Menarini partnership, noting that “the acceptance of our marketing authorization applications is a significant regulatory milestone that brings us closer to a European launch.” The company also highlighted the Alzheimer’s biomarker data as evidence of obicetrapib’s broader disease‑modifying potential. While the company did not provide new guidance for the next quarter, it reiterated its focus on advancing the PREVAIL cardiovascular outcomes trial and the planned RUBENS Phase 3 study in type 2 diabetes patients.
Overall, NewAmsterdam’s cash position remains robust, but the sharp revenue decline and widened net loss signal that the company’s financial performance will continue to be driven by milestone payments and clinical milestones rather than product sales. The EMA acceptance and Menarini partnership provide a clear path to European commercialization, while the Alzheimer’s biomarker data may open a second therapeutic avenue, positioning the company for future revenue growth once obicetrapib receives regulatory approval.
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