SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business Updates

Core Insights - SpringWorks Therapeutics reported strong financial results for the fourth quarter and full year 2024, achieving U.S. net product revenues of $61.5 million and $172.0 million for OGSIVEO® (nirogacestat) respectively [1][6] - The company received FDA approval for GOMEKLI™ (mirdametinib) for treating symptomatic NF1-PN in both adults and pediatric patients, marking a significant milestone in its product offerings [1][6] - As of December 31, 2024, SpringWorks had a cash position of $461.9 million, indicating a solid financial foundation for future growth [1][6] Financial Performance - OGSIVEO net product revenues were $61.5 million in Q4 2024 and $172.0 million for the full year 2024, a substantial increase compared to previous periods [6][19] - Selling, General and Administrative (SG&A) expenses rose to $77.1 million for Q4 2024 and $256.7 million for the full year, up from $59.8 million and $197.6 million in 2023, primarily due to commercial readiness activities for GOMEKLI and OGSIVEO [7][19] - Research and Development (R&D) expenses increased to $60.2 million in Q4 2024 and $200.5 million for the full year, compared to $43.7 million and $150.5 million in 2023, driven by higher external costs related to clinical trials and drug manufacturing [7][19] - The net loss attributable to common stockholders was $77.3 million, or $1.04 per share, for Q4 2024, and $258.1 million, or $3.48 per share, for the full year, showing improvement from the previous year's losses [7][19] Product Development and Pipeline - The company is advancing a diversified pipeline, including ongoing studies for nirogacestat in various indications, with initial data from a Phase 2 trial expected in the first half of 2025 [2][6] - A Marketing Authorization Application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with potential launch in Germany anticipated in mid-2025 [6][19] - GOMEKLI is now available through a specialty pharmacy network in the U.S., and an MAA for mirdametinib is also under review with the EMA [6][19] Strategic Outlook - The CEO expressed confidence in the company's ability to serve the desmoid tumor community and emphasized the importance of the recent FDA approval of GOMEKLI for expanding treatment options [2][6] - SpringWorks is committed to global expansion of its medicines and aims to develop important therapeutic advances for underserved patient populations [2][6]