Axsome Therapeutics-AXSM Q1 Loss Narrower Than Expected, Auvelity Drives Revenues Y/Y

Core Insights - Axsome Therapeutics reported an adjusted loss of $1.22 per share in Q1 2025, which is an improvement from the loss of$ 1.44 per share in the same quarter last year and better than the Zacks Consensus Estimate of a loss of $1.26 [1] - The company's total revenues increased by 62% year over year to$ 121.5 million in Q1 2025, surpassing the Zacks Consensus Estimate of $119 million, primarily driven by strong sales of Auvelity [2][5] - Year-to-date, Axsome's shares have increased by 37.7%, contrasting with a 2.2% decline in the industry [4] Financial Performance - Total revenues in Q1 2025 included product revenues from Auvelity and Sunosi, as well as royalty revenues, with net product revenues reaching$ 120.4 million compared to $74.1 million in the previous year [5] - Auvelity's sales were$ 96.2 million, reflecting an 80% year-over-year increase, with approximately 167,000 prescriptions recorded, marking a 76% increase from the previous year [6] - Sunosi's net product sales were $25.2 million, up 17% from the prior year, with total prescriptions growing 12% year over year to 46,000 [7] Expenses and Cash Position - Research and development expenses rose to$ 44.8 million, a 21.7% increase from the previous year, driven by higher costs related to clinical studies [9] - Selling, general, and administrative expenses totaled $120.8 million, up 22% year over year, attributed to increased commercial activities for Auvelity and pre-launch activities for Symbravo [10] - As of March 31, 2025, Axsome had cash and cash equivalents of$ 300.9 million, down from $315.4 million at the end of 2024 [11] Pipeline Developments - Axsome received positive feedback from the FDA regarding its plans to submit a supplemental new drug application for AXS-05 for agitation in Alzheimer's disease, expected in Q3 2025 [14] - The company plans to initiate a pivotal phase II/III study of Auvelity for smoking cessation later in 2025 and has submitted an NDA for AXS-14 for fibromyalgia treatment [15] - Axsome is also evaluating solriamfetol in phase III studies for ADHD and MDD, with plans to initiate additional studies later in 2025 [17][19] Market Position - Axsome currently holds a Zacks Rank of 3 (Hold), with better-ranked stocks in the biotech sector including ADMA Biologics and Immunocore Holdings, both carrying a Zacks Rank of 2 (Buy) [21]