NewAmsterdam Pharma (NAMS 0.13%), a clinical-stage biopharmaceutical company focused on developing oral therapies for cardiometabolic diseases, delivered its Q2 2025 earnings report on August 6, 2025. The most important news from the release was GAAP revenue of $19.1 million, a significant outperformance against the $12.8 million consensus estimate, mainly driven by milestone payments tied to its Menarini partnership in Europe. Net loss (GAAP) sharply improved year over year, narrowing as research and development spending declined, even as selling, general, and administrative costs climbed with commercial preparations. Overall, the quarter showed progress across clinical milestones, reinforced by a robust cash position and advancement toward pivotal regulatory events, while costs continued to rise as the company gears up for potential product launch.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | N/A | ($0.28) | N/A | N/A |
| Revenue (GAAP) | $19.1 million | $12.8 million | $2.3 million | 731.3 % |
| R&D Expenses | $27.5 million | $38.4 million | -28.4 % | |
| SG&A Expenses | $27.3 million | $16.5 million | 65.5 % | |
| Cash, Cash Equivalents & Marketable Securities | $783.3 million | $834.2 million1 | (6.1%) |
Source: Analyst estimates for the quarter provided by FactSet.
About the Business and Current Focus
NewAmsterdam Pharma develops oral therapies for cardiometabolic diseases. Its lead product candidate is obicetrapib, a daily oral cholesteryl ester transfer protein (CETP) inhibitor for lowering LDL-C (so-called “bad” cholesterol). The company operates in the pre-commercial stage, with revenues to date coming from research partnerships rather than drug sales.
The primary focus areas for NewAmsterdam Pharma include demonstrating the efficacy and safety of obicetrapib across its late-stage clinical trials, advancing regulatory approvals, and preparing for an eventual commercial launch. Its chief success factors are proving the clinical value of its product, achieving market access and reimbursement, staying ahead of competitors, building strategic partnerships, and maintaining the financial capacity to fund ongoing research and commercialization activities.
Quarter in Review: Financial, Clinical, and Strategic Highlights
The company’s revenue beat in Q2 2025 was driven by recognition of a $16.1 million milestone payment from the Menarini licensing agreement, rather than product sales. GAAP revenue for Q2 2025 was $19.1 million, compared to just $2.3 million in the prior-year period, illustrating the shift in the business model as partnership income picks up pace. Net loss (GAAP) was much lower than a year ago, at $17.4 million for Q2 2025 versus $39.0 million in the prior-year period, primarily due to lower research expenses as several late-phase studies wrapped up, offset somewhat by growing commercial costs and headcount-related expenses.
Research and development (R&D) expenses fell 28.4% in Q2 2025 compared to Q2 2024 as clinical expenses decreased. However, selling, general, and administrative (SG&A) expenses (GAAP) increased 65.5% in Q2 2025 versus Q2 2024, reflecting the buildout of commercial infrastructure and preparation for a potential launch if regulatory approvals come through. Share-based compensation, which is a non-cash expense reflecting stock awards to staff, rose sharply in both R&D and SG&A lines, aligning with the increase in staffing and retention as NewAmsterdam Pharma transitions toward a commercial entity.
Clinical developments remained central. The company reported new data from its BROADWAY trial showing that obicetrapib, as an oral CETP inhibitor, delivered statistically significant reductions in the Alzheimer’s biomarker plasma p-tau217, particularly in high-risk patients (ApoE4/E4 carriers), with a 20.5% reduction observed over 12 months compared to placebo. For this highest-risk group, a 20.5% reduction in biomarker levels was observed compared to placebo over 12 months. This aligns with earlier data showing robust LDL-C lowering in prior trials—33% in the Phase 3 BROADWAY and 36% in the Phase 3 BROOKLYN monotherapy studies, and 52% in the Phase 3 TANDEM study in combination with ezetimibe. The product continued to show a safety profile similar to placebo in these late-stage populations, with tolerability important for regulatory and payer acceptance.
On the regulatory front, NewAmsterdam Pharma confirmed its European marketing authorization application for obicetrapib is on track for 2H 2025. The pivotal PREVAIL cardiovascular outcomes trial had enrolled over 9,500 patients as of April 2024. Pipeline updates included plans to launch the RUBENS Phase 3 study, testing obicetrapib in combination with ezetimibe in patients with type 2 diabetes and metabolic syndrome, and further advanced coronary plaque studies. No product has yet launched, so all current revenue is from licensing and partnership income rather than sales.
The Menarini partnership provided both cash and strategic value in Q2 2025, with the second development payment from the agreement recognized as revenue and joint regulatory efforts progressing in Europe. Management highlighted the importance of this relationship in both funding and market access as the company builds toward commercialization. In addition, commercial readiness spending rose, with new investments in marketing and patent protection positioning NewAmsterdam Pharma for future market entry — but also contributing to the notable climb in SG&A expenses. The company hosted an R&D Day to outline ongoing clinical momentum and its approach to commercialization.
Looking Forward
Management did not provide precise financial guidance for the next quarter or full fiscal 2025. Instead, the company reiterated its focus on progressing its regulatory applications, preparing for commercial launch, and advancing the clinical development pipeline. The company stated its European submission for obicetrapib remains on track for 2H 2025, with the PREVAIL trial remaining the next material catalyst.
With no revenue yet from actual product sales, future quarters will turn on the outcome of key regulatory milestones, clinical trial readouts, and continued commercial buildout. Investors should keep an eye on expense trends for SG&A as pre-launch costs mount, cash runway management, and any shifts in the competitive cholesterol-lowering therapy space. NAMS does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
