Workflow
Syndax(SNDX) - 2025 Q1 - Quarterly Results
SNDXSyndax(SNDX)2025-05-05 20:02

Financial Performance - Syndax reported 20.0millioninnetrevenuefromRevuforjinthefirstquarterof2025,markingthefirstfullquarterofitsU.S.launch[5]−Niktimvogenerated20.0 million in net revenue from Revuforj in the first quarter of 2025, marking the first full quarter of its U.S. launch[5] - Niktimvo generated 13.6 million in net revenue in its first partial quarter of launch, with Syndax recording a 0.2millionshareofthenetcommercialloss[10]−Productrevenueforthefirstquarterof2025was0.2 million share of the net commercial loss[10] - Product revenue for the first quarter of 2025 was 20,042,000, compared to 0inthesameperiodof2024[34]−NetlossforQ12025was0 in the same period of 2024[34] - Net loss for Q1 2025 was 84,846,000, compared to a net loss of 72,400,000inQ12024,indicatinga17.272,400,000 in Q1 2024, indicating a 17.2% increase in losses[34] - Basic loss per share attributable to common stockholders was 0.98 in Q1 2025, compared to 0.85inQ12024,reflectinga15.30.85 in Q1 2024, reflecting a 15.3% increase[34] Expenses - Research and development expenses increased to 61.6 million in Q1 2025, up from 56.5millioninthesameperiodlastyear,primarilyduetoaxatilimab−relatedcosts[12]−Selling,generalandadministrativeexpensesroseto56.5 million in the same period last year, primarily due to axatilimab-related costs[12] - Selling, general and administrative expenses rose to 41.0 million in Q1 2025, compared to 23.0 million in the prior year, driven by increased employee-related expenses[13] - The company expects R&D expenses for Q2 2025 to be between 70 million and 75 million, with total expenses (R&D plus SG&A) projected at 110 million to 115million[15]−Totaloperatingexpensesincreasedto115 million[15] - Total operating expenses increased to 103,799,000 in Q1 2025, up from 79,514,000inQ12024,representinga30.579,514,000 in Q1 2024, representing a 30.5% increase[34] - Research and development expenses rose to 61,636,000 in Q1 2025, compared to 56,492,000inQ12024,markinganincreaseof9.556,492,000 in Q1 2024, marking an increase of 9.5%[34] - Selling, general and administrative expenses increased significantly to 41,031,000 in Q1 2025 from 23,022,000inQ12024,ariseof78.323,022,000 in Q1 2024, a rise of 78.3%[34] Cash and Assets - The company had cash, cash equivalents, and investments totaling 602.1 million as of March 31, 2025, expected to fund operations to profitability[9] - Cash, cash equivalents, and investments decreased to 602,135,000asofMarch31,2025,downfrom602,135,000 as of March 31, 2025, down from 692,404,000 as of December 31, 2024, a decline of 13.0%[32] - Total assets decreased to 640,707,000asofMarch31,2025,comparedto640,707,000 as of March 31, 2025, compared to 724,816,000 as of December 31, 2024, a reduction of 11.6%[32] - Total stockholders' equity fell to 215,059,000asofMarch31,2025,downfrom215,059,000 as of March 31, 2025, down from 288,124,000 as of December 31, 2024, a decrease of 25.3%[32] - Common stock outstanding increased to 86,047,032 shares as of March 31, 2025, compared to 85,694,443 shares as of December 31, 2024[32] Product Development and Market Opportunities - Syndax plans to initiate multiple trials of revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025[8] - The company submitted a supplemental New Drug Application (sNDA) for revumenib for the treatment of R/R mNPM1 AML in April 2025, seeking Priority Review[5] - Revuforj and Niktimvo are positioned to unlock multi-billion-dollar opportunities in their respective markets, supported by strong clinical data and ongoing trials[3]