SpringWorks (SWTX) Q2 Earnings Beat, Ogsiveo Drives Revenues

Financial Performance - SpringWorks Therapeutics, Inc. reported a loss of 54 cents per share in Q2 2024, significantly better than the Zacks Consensus Estimate of a loss of $1.12 and an improvement from a loss of $1.25 per share in the same quarter last year [1] - Total revenues for the quarter reached $59.7 million, exceeding the Zacks Consensus Estimate of $35 million [1] Revenue Breakdown - Total revenues included net product sales of Ogsiveo (nirogacestat) and other revenues, with Ogsiveo generating $40.2 million in net product revenues, a 91.4% increase sequentially due to strong demand [2][3] - The company did not report any revenues in the year-ago quarter [2] Product Development and Regulatory Updates - Ogsiveo became the first approved drug for treating desmoid tumors after receiving FDA approval in November 2023, and it has quickly established itself as the standard of care for systemic therapy in this indication [3][4] - A marketing authorization application for Ogsiveo is under review with the European Medicines Agency (EMA), with potential approval expected in 2025 [4] Expenses - Research and development expenses totaled $44.4 million in Q2 2024, a 23.7% increase from the previous year, driven by higher drug manufacturing costs and clinical study expenses [5] - Selling, general and administrative expenses were $57.8 million, up approximately 23% year over year, primarily due to costs associated with the launch of Ogsiveo and preparations for mirdametinib [6] Cash Position - As of June 30, 2024, SpringWorks had cash, cash equivalents, and marketable securities amounting to $521.9 million, down from $573 million as of March 31, 2024 [6] Recent Developments - In April 2024, the FDA approved a supplemental new drug application for higher doses of Ogsiveo, which is expected to enhance patient convenience [7] - The company submitted a new drug application for its investigational MEK inhibitor, mirdametinib, targeting neurofibromatosis type 1-associated plexiform neurofibromas, with a target action date to be announced soon [8] - SpringWorks plans to file a marketing application with the EMA for mirdametinib later in 2024 [9]