Executive Summary / Key Takeaways

• Differentiated Therapeutic Approach: NewAmsterdam Pharma (NAMS) is pioneering obicetrapib, an oral, once-daily CETP inhibitor, addressing significant unmet needs in cardiovascular disease (CVD) by substantially reducing LDL-C and Lp(a), with a safety profile comparable to placebo.
• Emerging Alzheimer's Potential: Recent positive data from the BROADWAY trial showing statistically significant reductions in a key Alzheimer's Disease (AD) biomarker (p-tau217) positions obicetrapib as a potential dual-threat therapy, significantly expanding its market opportunity beyond cardiometabolic health.
• Strong Liquidity for Clinical Advancement: With $783.3 million in cash, cash equivalents, and marketable securities as of June 30, 2025, NAMS possesses substantial runway to fund its ongoing Phase 3 PREVAIL cardiovascular outcomes trial and prepare for potential commercialization.
• Strategic Commercialization Pathway: The company has secured a lucrative European partnership with Menarini, including potential milestones up to €833 million and tiered double-digit royalties, while retaining full commercialization rights for the high-value U.S. market.
• High-Risk, High-Reward Profile: As a clinical-stage biopharmaceutical company, NAMS faces inherent risks related to regulatory approvals, clinical trial outcomes, and significant ongoing R&D expenses, but obicetrapib's unique mechanism and broad potential offer a compelling long-term growth narrative.

A New Dawn in Cardiometabolic and Neurodegenerative Care

NewAmsterdam Pharma (NASDAQ:NAMS) stands at a pivotal juncture, poised to redefine treatment paradigms in cardiometabolic diseases and potentially, neurodegeneration. The company's core mission is to address the substantial unmet needs of patients with elevated low-density lipoprotein cholesterol (LDL-C) who are inadequately managed by existing therapies or prefer oral alternatives. This focus is particularly critical given that cardiovascular disease (CVD) remains the leading cause of death globally, with U.S. age-adjusted CVD mortality rates increasing by 9% from 2019-2022, reversing a decade of progress. Despite 269 million lipid-lowering therapy (LLT) prescriptions in the last 12 months, 30 million under-treated U.S. adults are still not at their risk-based LDL-C goals.

The company's foundational strength lies in obicetrapib, its lead product candidate. This oral, low-dose, once-daily, highly selective cholesteryl ester transfer protein (CETP) inhibitor represents a differentiated technological approach. Unlike many existing therapies, obicetrapib not only reduces LDL-C but also significantly impacts other critical biomarkers. In pivotal Phase 3 trials (BROADWAY, BROOKLYN, TANDEM), obicetrapib demonstrated statistically significant LDL-C reductions: 35% as monotherapy adjunct to statins, and 50% in combination with ezetimibe. Pooled Phase 3 data further revealed a median placebo-adjusted reduction of 45% in lipoprotein(a) (Lp(a)) for patients with elevated baseline levels, a key independent risk factor for major adverse cardiovascular events (MACE). The drug has also shown reductions in small LDL particles, which are believed to be more atherogenic. Crucially, obicetrapib has been observed to be well-tolerated in over 3,500 patients, with a safety profile comparable to placebo, addressing a significant patient preference for oral over injectable therapies (preferred by over 75% of ASCVD and HeFH outpatients).

This technological differentiation extends beyond cardiometabolic health. On July 30, 2025, NAMS announced groundbreaking positive data from a prespecified Alzheimer's Disease (AD) biomarker analysis within its BROADWAY clinical trial. Treatment with obicetrapib 10 mg daily for 12 months resulted in statistically significant lower absolute changes in plasma p-tau217, a key biomarker of AD pathology, in both the full analysis set (p<0.0019, n=1,515) and in ApoE4 carriers (p<0.0215, n=367). Favorable trends were also observed across additional biomarkers such as neurofilament light chain (NFL) and glial fibrillary acidic protein (GFAP). Given that p-tau217 can increase more than 20 years before cognitive impairment onset and has high accuracy, these results suggest a potential to alter disease trajectory, especially for the approximately two-thirds of AD patients carrying the ApoE4 risk isoform. This dual therapeutic potential significantly broadens obicetrapib's addressable market and strengthens NAMS's competitive moat.

Financial Trajectory and Strategic Execution

NewAmsterdam Pharma's financial performance reflects its stage as a clinical-stage biopharmaceutical company, characterized by significant R&D investment and a strategic focus on pipeline development over immediate product sales. The company's revenue stream is currently derived solely from its licensing agreement with Menarini, which granted exclusive commercialization rights for obicetrapib in most European countries. For the three months ended June 30, 2025, revenue surged to $19.1 million, a 740% increase from $2.3 million in the prior year period. Similarly, for the six months ended June 30, 2025, revenue reached $22.1 million, up 501% from $3.7 million in the comparable 2024 period. This substantial growth was primarily driven by the recognition of a $16.1 million second installment of development cost contributions from the Menarini License, indicating the full satisfaction of the related R&D performance obligation.

Operating expenses, while still substantial, are evolving with the company's clinical progress. Research and development (R&D) expenses decreased by $10.9 million (28%) to $27.5 million for the three months ended June 30, 2025, and by $8.5 million (11%) to $72.3 million for the six-month period. This reduction was mainly attributable to the completion of several Phase 3 clinical trials in the second half of 2024 and cost phasing in ongoing trials. However, this was partially offset by increased personnel expenses (including share-based compensation), non-clinical expenses for pipeline expansion, and regulatory expenses for planned submissions. Conversely, selling, general and administrative (SG&A) expenses saw a significant increase, rising by $10.8 million (65%) to $27.3 million in Q2 2025, and by $23.5 million (76%) to $54.4 million in H1 2025. This was primarily due to higher personnel costs associated with administrative and commercial preparedness activities, increased marketing and communication efforts for a planned commercial launch, and global intellectual property filings.

As of June 30, 2025, NewAmsterdam Pharma reported a robust liquidity position with $783.3 million in cash, cash equivalents, and marketable securities. This strong cash balance, bolstered by recent public offerings in February and December 2024 that generated $190 million and $453.4 million in net proceeds, respectively, provides significant runway to fund ongoing operations and clinical development.

The company has an accumulated loss of $615.5 million and anticipates incurring significant losses for the foreseeable future as it continues to invest heavily in its clinical programs and prepare for potential commercialization. Potential proceeds from outstanding warrants (2.62 million at an $11.50 exercise price) are not factored into liquidity projections due to their market-dependent nature.

Competitive Landscape and Strategic Positioning

NewAmsterdam Pharma operates in a highly competitive biopharmaceutical market, facing established giants like Pfizer (PFE), Amgen (AMGN), and Merck (MRK). These competitors boast extensive, diversified portfolios, deep market penetration, and robust financial resources. For instance, Pfizer, Amgen, and Merck reported TTM gross profit margins of 66%, 62%, and 76% respectively, alongside positive operating and net profit margins, contrasting sharply with NAMS's 100% gross profit margin (due to licensing revenue, not product sales) and negative operating and net profit margins. Their price-to-sales ratios are also significantly lower (PFE: 2.36, AMGN: 4.22, MRK: 3.93) compared to NAMS's 45.91, reflecting NAMS's early revenue stage.

NAMS's strategic positioning hinges on its differentiated technology and patient-centric approach. While competitors offer a range of lipid-lowering therapies, including statins and injectable PCSK9 inhibitors, obicetrapib's oral administration and broad biomarker impact (LDL-C, Lp(a), small LDL, and now AD biomarkers) provide a unique value proposition. NAMS aims to capture market share by addressing the significant portion of patients who do not achieve LDL-C goals with existing statin therapy alone or prefer oral options over injectables.

The company's commercialization strategy is a blend of partnership and direct market entry. The Menarini License provides a clear pathway to the European market, with NAMS eligible for tiered double-digit royalties and up to an additional €833 million in milestone payments. This partnership leverages Menarini's established commercial infrastructure, reducing NAMS's immediate capital outlay for European market access. For the high-value U.S. market, NAMS intends to pursue commercialization independently, allowing it to capture a greater share of potential profits. The company is also actively exploring additional partnerships for other key regions like Japan and China. This multi-pronged strategy allows NAMS to maximize obicetrapib's global potential while focusing its internal resources on critical development and U.S. market preparation.

Outlook and Key Risks

The outlook for NewAmsterdam Pharma is characterized by significant clinical milestones and the potential for substantial market entry. The European marketing authorization application (MAA) for obicetrapib monotherapy and the fixed-dose combination with ezetimibe, submitted by Menarini, is on track for review by the European Medicine Agency (EMA) in the second half of 2025. Concurrently, the Phase 3 PREVAIL cardiovascular outcomes trial (CVOT), which completed enrollment of over 9,500 patients in April 2024, remains on track to confirm obicetrapib's potential to reduce MACE. These regulatory and clinical advancements are critical catalysts for the company's future. NAMS expects R&D expenses to remain significant as product candidates progress, and SG&A expenses to increase as it builds commercial capabilities.

Despite the promising outlook, investors must consider the inherent risks associated with a clinical-stage biopharmaceutical company. The primary risks include the uncertainty of regulatory approvals, which are essential for commercialization. The company's success is heavily dependent on obicetrapib, and any setbacks in clinical trials or regulatory processes could significantly impact its prospects. NAMS also faces risks related to its limited experience in marketing and distribution, particularly as it plans to self-commercialize in the U.S. Global economic and political conditions, including potential changes in U.S. government policies such as increased tariffs, could lead to higher production costs, supply chain disruptions, and adverse effects on financial performance. The ability to achieve broad physician adoption and market acceptance for obicetrapib, even if approved, remains a challenge in a market with established competitors.

Conclusion

NewAmsterdam Pharma presents a compelling investment narrative centered on obicetrapib, a differentiated oral CETP inhibitor with demonstrated efficacy in lowering LDL-C and Lp(a), coupled with a favorable safety profile. The recent positive Alzheimer's Disease biomarker data from the BROADWAY trial adds a transformative dimension, suggesting obicetrapib's potential to address a dual, high-value therapeutic need in cardiometabolic health and neurodegeneration. With a robust cash position providing ample runway for its ongoing PREVAIL CVOT and commercialization preparations, NAMS is strategically positioned to leverage its European partnership with Menarini while pursuing direct market entry in the U.S.

While the company operates in a competitive landscape dominated by larger pharmaceutical players and faces the typical risks of a clinical-stage biotech, obicetrapib's unique mechanism, oral convenience, and expanding therapeutic potential offer a strong foundation for long-term growth. The successful progression of its regulatory filings and the outcomes of the PREVAIL trial will be critical determinants of its future. For discerning investors, NAMS represents an opportunity to participate in a company with a potentially groundbreaking therapy that could significantly improve patient outcomes across two major disease areas, driven by a clear strategic vision and a differentiated technological edge.