NAMS
NewAmsterdam Pharma Company N.V.34.22
-1.13-3.2%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
3.88BP/E (TTM)
-Basic EPS (TTM)
-2.04Dividend Yield
0%Recent Filings
8-K
Obicetrapib Phase 3 highlights
NewAmsterdam Pharma updated its corporate investor presentation on September 2, 2025, highlighting obicetrapib's Phase 3 successes: 35-40% LDL-C reduction as monotherapy, up to 50% with ezetimibe, and 45% Lp(a) lowering. Exploratory data showed a 21% MACE reduction in BROADWAY, while the Alzheimer's sub-study revealed a 2.99% p-tau217 benefit, rising to 20.5% in ApoE4 homozygotes. With $780M cash supporting a 2H 2025 EMA submission, obicetrapib targets unmet needs in cardiometabolic and neuro-metabolic diseases. PREVAIL CVOT readout expected FY 2026.
8-K
EMA validates obicetrapib MAAs
NewAmsterdam Pharma's partner Menarini submitted Marketing Authorization Applications for obicetrapib monotherapy and its ezetimibe fixed-dose combination to the EMA on August 18, 2025, triggering validation for substantive review based on Phase 3 trials showing 35%-40% LDL-C reductions as monotherapy and 50% in combination, with placebo-like safety. This advances European approval for treating primary hypercholesterolemia and mixed dyslipidemia, where patients often miss LDL-C targets despite statins. NewAmsterdam stands to gain up to €833 million in milestones plus tiered royalties from low double-digits to mid-twenties on net sales. Regulatory hurdles persist amid clinical uncertainties.
8-K
Supply deal with Menarini signed
NewAmsterdam Pharma's subsidiary inked a supply agreement with Menarini on August 12, 2025, to provide obicetrapib monotherapy and fixed-dose combination tablets, initially as exclusive supplier based on binding forecasts. Pricing ties to a markup on cost of goods sold, with plans to transfer manufacturing to Menarini or a third party, granting a non-exclusive license under company patents. The deal runs with the existing license term but allows termination for convenience post-transfer. This secures steady supply while easing long-term production burdens.
10-Q
Q2 FY2025 results
NewAmsterdam Pharma posted Q2 revenue of $19.1M from its Menarini license, up sharply from $2.3M a year earlier, thanks to recognizing $16.1M in development reimbursements after satisfying R&D obligations. Operating loss narrowed to $35.6M from $52.6M y/y, driven by 28% lower R&D spend on completed Phase 3 trials, though SG&A climbed 65% to $27.3M for commercial prep and hiring. Net loss improved to $17.4M or $(0.15) per share from $39.0M or $(0.41), aided by $7.1M interest income and $8.6M forex gains; EPS aligns with 118.6M diluted shares. Cash and equivalents stood at $563.9M after $74.1M operating burn, with no debt but $20.9M warrant liabilities. In March, the earnout settled via 1.7M shares issuance upon milestone hit. Yet tariffs on imports could hike supply chain costs.
8-K
Q2 results and obicetrapib updates
NewAmsterdam Pharma reported Q2 2025 financials, highlighting $783.3 million in cash and a narrowed net loss of $17.4 million versus $39.0 million last year, fueled by $19.1 million revenue from Menarini contributions. Obicetrapib's BROADWAY analysis showed significant p-tau217 reductions in Alzheimer's biomarkers over 12 months, while PREVAIL CVOT stays on track. EMA filing eyes 2H25 approval. Cash burn persists amid trials.
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