Axsome Therapeutics Reports $287.2 Million Net Loss and $381.7 Million Revenue for Fiscal Year 2024

Axsome Therapeutics, Inc. reported a net loss of $287.2 million for the fiscal year ended December 31, 2024, compared to a net loss of $239.2 million in 2023. The increase in net loss is attributed to higher research and development expenses, increased selling, general, and administrative expenses related to the commercialization of Auvelity and Sunosi, and higher personnel costs due to organizational growth, including non-cash stock compensation. The company generated $381.7 million in net revenue from product sales in 2024, a significant increase from $202.5 million in 2023, primarily driven by increased unit sales volume of Auvelity and Sunosi. The company also reported $4.0 million in royalty and milestone revenue in 2024.

Significant changes compared to the previous fiscal year include a substantial increase in net revenue from product sales, driven by the commercial success of Auvelity and Sunosi. Cost of revenue also increased, reflecting the higher sales volume. Research and development expenses rose considerably due to the advancement of several clinical trials, including those for additional indications of solriamfetol (Sunosi) and AXS-05 (Auvelity), and increased manufacturing costs for AXS-07 (Symbravo) and AXS-14. Selling, general, and administrative expenses also increased, primarily due to expanded commercial activities and higher personnel costs.

Strategic developments during the year included the successful completion of Phase 3 clinical trials for AXS-05 in Alzheimer's disease agitation, and the initiation of Phase 3 trials for solriamfetol in ADHD, MDD, BED, and SWD. The company also announced the FDA approval of Symbravo in January 2025 for the acute treatment of migraine. In February 2023, Axsome entered into a licensing agreement with Pharmanovia, granting exclusive rights to market Sunosi in Europe and certain Middle Eastern and North African countries. The company also settled patent litigation related to Auvelity and Sunosi, granting licenses to generic versions of these products beginning in 2038 or 2039, depending on pediatric exclusivity.

As of February 11, 2025, Axsome had 683 full-time employees. The company's financial statements include significant judgments and estimates related to revenue recognition, particularly concerning variable consideration from rebates, discounts, and returns. The company's cash and cash equivalents totaled $315.4 million as of December 31, 2024. The company anticipates continued losses in the near term but expects its research and development expenses to stabilize as certain programs near completion. The company's outlook is contingent upon the successful development and commercialization of its product candidates and the continued market acceptance of its existing products. The company's financial performance is subject to various risks, including competition, regulatory approvals, and market conditions, as detailed in the 10-K filing.