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Dec 31, 2024
NewAmsterdam Pharma Q4 2024 Earnings Report
NewAmsterdam Pharma reported its full year 2024 financial results, highlighting significant progress in clinical development and a strong financial position.
Key Takeaways
NewAmsterdam Pharma reported a net loss of $241.6 million for the full year 2024, an increase from $176.9 million in 2023. The company's revenue increased to $45.6 million in 2024 from $14.1 million in 2023, primarily due to a clinical success milestone and development cost reimbursement. Cash and cash equivalents significantly increased to $771.7 million by year-end 2024, driven by successful financing rounds.
NewAmsterdam Pharma reported a full-year 2024 net loss of $241.6 million, compared to $176.9 million in 2023.
Full-year 2024 revenue increased to $45.6 million from $14.1 million in 2023, driven by a clinical success milestone and development cost reimbursement.
Cash and cash equivalents, along with marketable securities, totaled $834.2 million as of December 31, 2024, a substantial increase from $340.5 million in 2023.
The company completed enrollment for the PREVAIL Phase 3 CVOT trial in April 2024 and expects EMA submission in 2H25.
Forward Guidance
NewAmsterdam Pharma anticipates continued progress in clinical development and regulatory interactions, with an EMA submission expected in the second half of 2025. The company is also focusing on launch readiness for obicetrapib in the U.S. and Europe, if approved, supported by strong financial capital.
Positive Outlook
- EMA submission for obicetrapib expected in 2H25 by partner Menarini.
- Additional data from BROADWAY, BROOKLYN, and TANDEM trials to be presented throughout 2025.
- Phase 3 PREVAIL CVOT remains on track with enrollment completed in April 2024.
- Increasing focus and efforts on launch readiness, including scaling up inventory and commercial capabilities.
- Sufficient capital to fund operations beyond PREVAIL CVOT readout and commercial launch in the U.S.
Challenges Ahead
- Regulatory approval is not guaranteed and is subject to review processes.
- Commercial launch is contingent on regulatory approval.
- The company's financial performance is subject to market, financial, political, and legal conditions.
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