NAMSWMEDIUM SIGNALREGULATORY10-K

NewAmsterdam Pharma achieved a significant regulatory milestone with EMA acceptance of Marketing Authorization Applications for obicetrapib in Europe, while share count increased 4.7% and cash burned down significantly.

The EMA's acceptance of MAAs in August 2025 represents meaningful progress toward commercialization in Europe through the Menarini partnership, potentially validating the company's clinical development strategy. However, the company's cash position declined substantially by $281.7M year-over-year, raising questions about funding runway as they advance toward commercialization.

Comparing 2026-02-18 vs 2025-02-26View on EDGAR →
FINANCIAL ANALYSIS

The company shows classic biotech cash burn patterns with revenue declining 50.6% to $22.5M while SG&A expenses surged 51% to $106.4M, likely reflecting increased commercial preparation activities. Cash and equivalents fell significantly from $771.7M to $490.0M, though this remains a substantial war chest, while the overall balance sheet contracted 11% but maintained a strong net cash position with liabilities decreasing 19.9%. The financial profile suggests heavy investment in advancing toward commercialization while maintaining adequate liquidity.

FINANCIAL STATEMENT CHANGES
SG&A Expense
P&L
+51%
$70.4M→$106.4M

SG&A up 51% — significant increase in sales or administrative costs, monitor impact on operating leverage.

Revenue
P&L
-50.6%
$45.6M→$22.5M

Revenue declined 50.6% — significant demand weakness or market share loss warrants investigation.

Cash & Equivalents
Balance Sheet
-36.5%
$771.7M→$490.0M

Cash declined 36.5% — significant cash burn or deployment; verify adequacy of remaining liquidity runway.

Interest Expense
P&L
-30.2%
$411K→$287K

Interest expense declined — debt repayment or refinancing at lower rates improving earnings quality.

Operating Income
P&L
-28%
-$176.3M→-$225.7M

Operating profitability softening — costs rising faster than revenue, watch for margin recovery plan.

Current Assets
Balance Sheet
-21.7%
$863.4M→$675.7M

Current assets declined 21.7% — monitor working capital adequacy and short-term liquidity.

Total Liabilities
Balance Sheet
-19.9%
$107.1M→$85.9M

Liabilities reduced 19.9% — deleveraging improves balance sheet strength and financial flexibility.

Current Liabilities
Balance Sheet
-19.8%
$106.9M→$85.8M

Current liabilities reduced — improved short-term financial position and working capital health.

Net Income
P&L
+15.6%
-$241.6M→-$203.8M

Net income grew 15.6% — bottom-line growth signals improving overall business health.

Total Assets
Balance Sheet
-11%
$864.6M→$769.3M

Total assets contracted 11% — asset sales, write-downs, or balance sheet optimization underway.

LANGUAGE CHANGES
NEW — 2026-02-18
PRIOR — 2025-02-26
ADDED
As of February 5, 2026, there were 114,975,422 of the registrant s ordinary shares, nominal value 0.12 per share, outstanding.
Form 10-K Summary 135 Signatures 136 Financial Statements F- 1 ____________________ Unless otherwise stated or the context otherwise indicates, references to we, our, us or the Company refer to NewAmsterdam Pharma Company N.V., together with its subsidiaries.
In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering.
In each of these trials, side effects were similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment-emergent serious adverse events ( TESAEs ).
We have partnered with Menarini, providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in an FDC with ezetimibe, in the majority of European countries (the "Menarini Territory"), if approved.
In August 2025, the EMA accepted for review the Marketing Authorization Applications ("MAAs") submitted by Menarini for obicetrapib 10 mg monotherapy and the FDC of 10 mg obicetrapib plus 10 mg ezetimibe for the treatment of primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia.
Subsequently, MAAs were also submitted to regulators in the United Kingdom ("UK") and Switzerland and accepted for review.
The submissions are supported by data from the BROADWAY, BROOKLYN, and TANDEM pivotal Phase 3 trials.
We anticipate that Menarini will receive decisions on the MAAs from each of the regulators in the second half of 2026.
If the 7 MAAs are approved by the regulators, Menarini will be required to use commercially reasonable efforts to commercialize obicetrapib in the Menarini Territory.
REMOVED
As of February 18, 2025, there were 109,817,812 of the registrant s ordinary shares, nominal value 0.12 per share, outstanding.
3 Unless otherwise stated or the context otherwise indicates, (i) references to we, our, us or the Company refer to NewAmsterdam Pharma Company N.V., together with its subsidiaries and (ii) references to NewAmsterdam Pharma refer solely to NewAmsterdam Pharma Holding B.V., a private company with limited liability ( besloten vennootschap met beperkte aansprakelijkheid ) incorporated under the laws of the Netherlands and its subsidiaries.
We no longer qualify as an emerging growth company as of December 31, 2024 and, as a result, we are no longer able to avail ourselves of certain reduced disclosure requirements applicable to emerging growth companies and therefore expect to incur increased expenses due to increased disclosure requirements.
In addition to LDL-C, obicetrapib has shown significant reductions in lipoprotein(a) ("Lp(a)") and small LDL particles, all with safety comparable to placebo.
In five of our Phase 2 clinical trials, TULIP, ROSE, OCEAN, ROSE2 and our Japan Phase 2b clinical trial, evaluating obicetrapib as a monotherapy or a combination therapy with ezetimibe 10 mg, we observed statistically significant LDL-C lowering with side effects similar in frequency and severity to placebo including muscle-related side effects and drug-related treatment-emergent serious adverse events ( TESAEs ).
We have partnered with Menarini, providing them with the exclusive rights to commercialize obicetrapib 10 mg, either as a sole active ingredient product or in a fixed-dose combination with ezetimibe, in the majority of European countries, if approved.
Subject to receipt of marketing approval, our current plan is to pursue development and commercialization of obicetrapib in the United States ourselves, and to consider additional partners for jurisdictions outside of the United States and the European Union (the EU ), including in Japan and China.
7 The following table summarizes our current clinical programs: * Other than as noted, the pipeline represents trials that are currently ongoing.
The timing of regulatory submissions is subject to additional discussions with regulators.
We currently expect to report additional data from each study over the course of 2025.
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