Business Overview and History

NewAmsterdam Pharma Company N.V. (NAMS) is a late-stage biopharmaceutical company dedicated to improving patient care in populations with cardiometabolic diseases where currently approved therapies have fallen short. The company's mission is to develop innovative, non-statin medicines that can effectively address the significant unmet need for safe, well-tolerated, and convenient low-density lipoprotein cholesterol (LDL-C) lowering therapies.

NewAmsterdam Pharma Company N.V. was incorporated in the Netherlands as a private company with limited liability in June 2022. The company's primary focus has been on the development of obicetrapib, an oral, low-dose, once-daily, highly selective cholesterol ester transfer protein (CETP) inhibitor. This innovative therapy is designed to potentially overcome the limitations of current LDL-C lowering treatments.

In November 2022, NewAmsterdam Pharma underwent a significant transformation through an internal reorganization and merger with Frazier Lifesciences Acquisition Corporation (FLAC), a special purpose acquisition company. This strategic move resulted in NewAmsterdam Pharma becoming a publicly traded company, with its ordinary shares and warrants listed on the Nasdaq Global Market. Prior to this merger, NewAmsterdam Pharma Holding B.V. served as the operating company, conducting research and development activities for obicetrapib.

Throughout 2022 and 2023, NewAmsterdam Pharma made substantial progress in its clinical development program. The company conducted several Phase 2 clinical trials evaluating obicetrapib both as a monotherapy and in combination with ezetimibe, an approved LDL-C lowering medication. These trials yielded promising results, demonstrating significant reductions in LDL-C levels while maintaining a favorable tolerability profile.

Building on the success of its Phase 2 program, NewAmsterdam Pharma initiated multiple Phase 3 clinical trials in 2023, including the BROADWAY, BROOKLYN, and TANDEM trials. These pivotal studies were designed to evaluate obicetrapib's efficacy and safety as both a monotherapy and in a fixed-dose combination with ezetimibe. Despite facing challenges related to the COVID-19 pandemic, which impacted clinical trial enrollment and execution, the company successfully navigated these obstacles and announced positive topline data from all three trials in late 2024.

The company's breakthrough moment came in 2022 when it completed a business combination with Frazier Lifesciences Acquisition Corporation (FLAC), a special purpose acquisition company (SPAC). This transaction provided NewAmsterdam Pharma with the necessary capital and public market exposure to accelerate the clinical development of obicetrapib and prepare for its potential commercialization.

Since the completion of the business combination, NewAmsterdam Pharma has made significant strides in its clinical program. In 2024, the company reported positive topline data from its pivotal Phase 3 BROADWAY and BROOKLYN trials, which evaluated obicetrapib as a monotherapy in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). These trials met their primary endpoints, demonstrating statistically significant reductions in LDL-C levels compared to placebo.

Building on this momentum, NewAmsterdam Pharma also reported positive results from its Phase 3 TANDEM trial, which assessed a fixed-dose combination of obicetrapib and ezetimibe. The trial met all co-primary endpoints, showing that the combination therapy was able to lower LDL-C by approximately 50% compared to placebo, with over 70% of patients achieving LDL-C levels below 55 mg/dL.

The company's clinical development efforts have been further bolstered by a strategic partnership with Menarini, a leading European pharmaceutical company. Under the terms of the agreement, Menarini has been granted exclusive rights to commercialize obicetrapib in the majority of European countries, should the product receive regulatory approval.

As NewAmsterdam Pharma enters the final stages of its clinical program, the company is also focused on preparing for the potential commercialization of obicetrapib. This includes establishing manufacturing capacity, building inventory, and laying the groundwork for a successful launch in key markets.

Financial Strength and Liquidity

NewAmsterdam Pharma's financial position has been significantly strengthened by the proceeds from its public offerings in 2024. As of December 31, 2024, the company reported a cash, cash equivalents, and marketable securities balance of $834.2 million, providing ample runway to support its ongoing clinical trials and commercial readiness efforts.

For the full year 2024, NewAmsterdam Pharma reported total revenue of $45.56 million, primarily driven by milestone payments and reimbursements related to its licensing agreement with Menarini. The company's net loss for the year was $241.60 million, reflecting the significant investment in its clinical development programs. Operating cash flow for the year was negative $158.56 million, while free cash flow was negative $159.24 million.

In the fourth quarter of 2024, the company reported revenue of $12.77 million and a net loss of $92.18 million. As a small-cap company, NewAmsterdam Pharma currently only sells its products in the United States and does not provide performance data by geographic market.

Despite the substantial operating expenses associated with its research and development activities, NewAmsterdam Pharma's balance sheet remains solid. As of December 31, 2024, the company had a current ratio of 8.08 and a quick ratio of 8.08, indicating strong short-term liquidity. The debt-to-equity ratio stood at a low 0.0006, demonstrating minimal leverage.

Research and development expenses for 2024 totaled $151.41 million, while selling, general, and administrative expenses were $70.45 million. These significant investments reflect the company's commitment to advancing its clinical pipeline and preparing for potential commercialization.

Operational Highlights and Milestones

Throughout 2024, NewAmsterdam Pharma made significant progress in its clinical development efforts:

• In July 2024, the company announced positive topline data from its pivotal Phase 3 BROOKLYN trial, which evaluated obicetrapib in patients with HeFH. The trial met its primary endpoint, demonstrating a 36.3% reduction in LDL-C compared to placebo at day 84 and a 41.5% reduction at day 365.

• In December 2024, NewAmsterdam Pharma reported positive results from its pivotal Phase 3 BROADWAY trial, which assessed obicetrapib in patients with ASCVD and/or HeFH. The trial met its primary endpoint, achieving a statistically significant 33% reduction in LDL-C compared to placebo at day 84. The BROADWAY trial also observed a 21% reduction in the exploratory major adverse cardiovascular event (MACE) endpoint, which included coronary heart disease death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization.

• In November 2024, the company announced positive topline data from its Phase 3 TANDEM trial, which evaluated a fixed-dose combination of obicetrapib and ezetimibe. The trial met all co-primary endpoints, demonstrating a 52.2% reduction in LDL-C compared to placebo at day 84.

These compelling clinical results have positioned obicetrapib as a potential breakthrough therapy in the treatment of cardiometabolic diseases, particularly for patients who are unable to achieve their LDL-C goals with existing therapies. Across all trials, obicetrapib has been observed to be well-tolerated in an aggregate of over 3,500 patients with dyslipidemia.

Looking ahead, NewAmsterdam Pharma's key priorities for 2025 include:

• Presenting additional data from the BROADWAY, BROOKLYN, and TANDEM trials throughout the year to support global regulatory filings.

• Advancing the Phase 3 PREVAIL cardiovascular outcomes trial, which is designed to assess the potential of obicetrapib to reduce major adverse cardiovascular events.
• Establishing manufacturing capacity and building inventory to support the potential commercialization of obicetrapib, in collaboration with its partner Menarini.
• Initiating a Phase 2 VINCENT trial to evaluate the effect of obicetrapib, alone and in combination with a PCSK9 inhibitor, on lipoprotein(a) levels.

Risks and Challenges

Despite the impressive progress made by NewAmsterdam Pharma, the company faces several risks and challenges that investors should consider:

1. Regulatory Approval: While the company's clinical trials have yielded positive results, there is no guarantee that obicetrapib will receive regulatory approval from the FDA, EMA, or other relevant authorities. Any setbacks or delays in the approval process could significantly impact the company's timeline and financial performance.

2. Commercial Execution: Even if obicetrapib is approved, NewAmsterdam Pharma's success will depend on its ability to effectively commercialize the product, either independently or through its partnership with Menarini. Factors such as pricing, reimbursement, and market acceptance could all influence the product's commercial viability.

3. Competition: The cardiovascular disease treatment landscape is highly competitive, with several established therapies and pipeline candidates targeting LDL-C reduction. NewAmsterdam Pharma will need to differentiate obicetrapib and demonstrate its superiority over existing and emerging treatments.

4. Reliance on Obicetrapib: As NewAmsterdam Pharma's sole product candidate, the company's future is heavily dependent on the successful development and commercialization of obicetrapib. Any setbacks or failures related to this asset could have a significant impact on the company's financial and operational performance.

5. Financing and Cash Management: While NewAmsterdam Pharma currently has a strong cash position, the company's ongoing clinical trials and commercial preparation activities will require substantial investments. Effectively managing its cash resources and securing additional financing, if necessary, will be crucial to the company's long-term success.

Conclusion

NewAmsterdam Pharma is at the forefront of developing innovative, non-statin therapies to address the significant unmet need in the treatment of cardiometabolic diseases. The company's lead candidate, obicetrapib, has demonstrated impressive LDL-C lowering capabilities in its clinical trials, positioning it as a potential game-changer in the treatment of high-risk cardiovascular patients.

With a robust clinical pipeline, a strategic partnership with Menarini, and a strong financial position, NewAmsterdam Pharma is well-equipped to navigate the challenges of the biopharmaceutical industry and continue advancing its mission of improving patient care. As the company prepares for the potential commercialization of obicetrapib, investors will closely watch its ability to execute on its strategic priorities and capitalize on the significant market opportunity in the cardiovascular disease treatment space.