Syndax(US:SNDX)2025-03-03 12:05Financial Performance - Revuforj generated net product revenue of $7.7 million for the twelve months ended December 31, 2024, following its FDA approval on November 15, 2024[348]. - The company reported net losses of $318.8 million, $209.4 million, and $149.3 million for the years ended December 31, 2024, 2023, and 2022, respectively[344]. - Total revenue for the year ended December 31, 2024, was $23.68 million, an increase of $23.68 million compared to 2023[373]. - Net product revenue from sales of Revuforj in the United States was $7.68 million, with milestone revenue of $16 million achieved through collaboration agreements[374][375]. - Total operating expenses for 2024 were $363.35 million, an increase of $133.4 million from 2023[373]. - As of December 31, 2024, the company had an accumulated deficit of $1.2 billion and anticipates continuing to incur significant losses for at least the next several years[1]. Cash and Investments - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $692.4 million[344]. - Net cash used in operating activities for the year ended December 31, 2024, was $274.9 million, primarily due to a net loss of $318.8 million adjusted for non-cash items[4]. - Net cash provided by financing activities for the year ended December 31, 2024, was $353.4 million, mainly from proceeds of $343.7 million from the Royalty Pharma Purchase and Sale agreement[6]. - Net cash provided by investing activities for the year ended December 31, 2024, was $219.8 million, resulting from $337.3 million in proceeds from the maturities of available-for-sale marketable securities[5]. - The company had cash, cash equivalents, and short-term and long-term investments totaling $692.4 million as of December 31, 2024[9]. - The company anticipates needing additional capital to fund operations, which may lead to dilution of existing stockholders' ownership interests[1]. Expenses and Future Projections - Research and development expenses are expected to continue to grow significantly as the company advances its product candidates[356]. - Selling, general and administrative expenses are anticipated to increase as the company expands its workforce to support research and commercialization efforts[360]. - Research and development expenses increased by $78.6 million to $241.65 million in 2024, primarily due to costs related to Revumenib and Axatilimab[377]. - Selling, general and administrative expenses rose by $54 million to $120.88 million, driven by increased commercial readiness and personnel costs[378]. - The company anticipates future capital requirements will depend on clinical trial outcomes, regulatory approvals, and market acceptance of product candidates[388]. Tax and Regulatory Matters - The company had federal and state tax net operating loss carryforwards of approximately $181.0 million and $97.5 million, respectively, as of December 31, 2024[7]. - The company recorded a valuation allowance on all deferred tax assets, including those related to net operating loss and research and development tax credit carryforwards[10]. Product Development and Collaborations - The company plans to submit a supplemental New Drug Application for revumenib in Q2 2025 for the treatment of R/R acute myeloid leukemia[344]. - The company is exploring the use of revumenib in solid tumors, specifically metastatic colorectal cancer[344]. - The company recognized $3.5 million in milestone revenue in Q2 2024 from the Eddingpharm license agreement and $12.5 million in Q3 2024 from the Incyte Collaboration Agreement[353]. - A purchase and sale agreement with Royalty Pharma was executed for $350 million, granting rights to receive 13.8% of quarterly net sales of Niktimvo[384]. - The company has not generated substantial product revenue to date, relying on equity offerings and collaborations for financing[388].