SpringWorks Therapeutics(SWTX) - 2025 Q1 - Quarterly Report

Revenue and Product Performance - SpringWorks Therapeutics recorded net product revenue of $44.1 million from sales of OGSIVEO in the United States for the three months ended March 31, 2025[76]. - GOMEKLI, approved on February 11, 2025, generated net product revenue of $4.9 million in the United States for the three months ended March 31, 2025[83]. - For the three months ended March 31, 2025, the company recorded net product revenue of $49.1 million, a 134% increase from $21.0 million in the same period of 2024[103]. - The FDA approved OGSIVEO in November 2023, generating $44.1 million in net product revenue for the three months ended March 31, 2025[104]. - The FDA approved GOMEKLI in February 2025, contributing $4.9 million in net product revenue for the three months ended March 31, 2025[105]. Clinical Trials and Approvals - The FDA approved OGSIVEO on November 27, 2023, based on a Phase 3 trial showing a 71% reduction in the risk of disease progression compared to placebo[72]. - The Phase 2b ReNeu trial for GOMEKLI showed a 52% objective response rate in pediatric patients and 41% in adult patients[80]. - The company is evaluating nirogacestat in combination with BCMA-directed therapies for multiple myeloma through non-exclusive clinical collaborations[87]. - SpringWorks is also advancing mirdametinib for genetically defined metastatic solid tumors targeting the MAPK pathway[88]. Financial Performance - Operating costs and expenses totaled $129.6 million for the three months ended March 31, 2025, a 13% increase from $114.9 million in the same period of 2024[103]. - Research and development expenses decreased by 8% to $49.6 million for the three months ended March 31, 2025, down from $53.6 million in the same period of 2024[109]. - Selling, general and administrative expenses increased by 27% to $76.5 million for the three months ended March 31, 2025, compared to $60.1 million in the same period of 2024[107]. - The net loss for the three months ended March 31, 2025, was $83.2 million, a slight improvement from a net loss of $87.4 million in the same period of 2024[114]. - The accumulated deficit stood at $1.2 billion as of March 31, 2025, unchanged from December 31, 2024[114]. Merger and Corporate Strategy - The company entered into a merger agreement with Merck KGaA, with each share of common stock valued at $47.00[68]. - A termination fee of $145.6 million is required if the merger agreement is terminated under specific circumstances[69]. - The company entered into a Merger Agreement on April 27, 2025, which includes various covenants and a potential termination fee of $145.6 million[113]. Cash Flow and Funding - Net cash used in operating activities was $68.8 million for the three months ended March 31, 2025, compared to $78.9 million for the same period in 2024, reflecting a decrease of 14.1%[117]. - Net cash provided by investing activities was $73.4 million for the three months ended March 31, 2025, driven by the sale and maturities of available-for-sale debt securities, compared to $103.9 million in 2024[118]. - Net cash used in financing activities was $10.6 million for the three months ended March 31, 2025, primarily due to stock repurchases of $12.9 million, partially offset by proceeds from stock option exercises of $2.3 million[119]. - Cash and cash equivalents at the end of the period were $64.4 million as of March 31, 2025, down from $118.6 million at the end of the same period in 2024, representing a decrease of 45.6%[116]. - Future funding requirements will depend on costs associated with the commercialization of OGSIVEO and GOMEKLI, as well as the progress and costs of clinical trials for product candidates[121]. - The company expects to finance operations through a combination of equity offerings, debt financings, and collaborations, which may dilute current ownership interests[123]. Market and Economic Conditions - The company does not believe inflation has had a material impact on its business or financial condition during the reported periods[124]. - The company is unable to estimate increased capital outlays and operating expenditures associated with current and anticipated clinical studies due to numerous risks and uncertainties[122]. - There were no material changes to market risks from those described in the previous Form 10-K[128]. - There were no material changes to contractual obligations during the three months ended March 31, 2025, compared to previous disclosures[125].