AXSM Q4 Loss Wider Than Expected, Revenues Surge Y/Y on Auvelity Sales

Core Insights - Axsome Therapeutics reported a loss of 71 cents per share in Q4 2025, which was wider than the expected loss of 70 cents, compared to a loss of 96 cents per share in the same quarter last year [1][6] - The company's total revenues increased by 65% year over year to $196 million in Q4, surpassing the consensus estimate of $193 million, primarily driven by strong sales of Auvelity [2][6] Financial Performance - Total revenues in Q4 included product revenues from Auvelity, Sunosi, and Symbravo, with net product revenues reaching $194.7 million, a 66% increase year over year [3] - Auvelity sales were $155.1 million, up 68% from the previous year, exceeding the consensus estimate of $151 million [4][6] - Sunosi's net product sales were $36.7 million, reflecting a 40% increase year over year, with total prescriptions growing 11% to 54,000 [7] Expenses and Cash Position - Research and development expenses were $48.8 million, down 11.3% from the previous year due to the completion of label expansion studies [10] - Selling, general, and administrative expenses rose to $169.3 million, a 49.4% increase year over year, attributed to higher commercial activities for Auvelity and ongoing launch activities for Symbravo [11] - As of December 31, 2025, Axsome had cash and cash equivalents of $322.9 million, slightly down from $325.3 million at the end of Q3 2025, which is expected to fund operations into cash flow positivity [12] Full-Year Results - For the full year 2025, Axsome generated revenues of $638.5 million, a 66% growth year over year, with an adjusted loss of $3.68 per share, an improvement from a loss of $5.99 in the previous year [13] Pipeline Developments - Axsome is conducting label expansion studies for Auvelity and has submitted a supplemental new drug application for AXS-05 for Alzheimer's disease agitation, with a decision expected by April 30, 2026 [14] - The company plans to initiate a pivotal phase II/III study of AXS-05 for smoking cessation in Q2 2026, and is evaluating AXS-12 and AXS-14 for multiple CNS indications [15][16] - AXS-12 is in late-stage studies for narcolepsy, with a potential NDA submission planned for the first quarter of 2026 [16] - Axsome is also conducting phase III studies for solriamfetol targeting ADHD, MDD, binge eating disorder, and excessive sleepiness associated with shift work disorder, with data expected in 2026 and 2027 [17][18]