Axsome Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update

Financial Performance - Total net product revenue for Q2 2024 was $87.2 million, representing an 87% year-over-year growth from $46.7 million in Q2 2023 [3] - Auvelity net product sales reached $65.0 million in Q2 2024, marking a 135% increase from $27.6 million in Q2 2023 [3] - Sunosi net product revenue was $22.1 million in Q2 2024, which includes $21.5 million in net product sales and $0.6 million in royalty revenue, reflecting a 16% growth from $19.1 million in Q2 2023 [3] Expenses - Total cost of revenue for Q2 2024 was $8.1 million, up from $4.6 million in Q2 2023 [4] - Research and development (R&D) expenses were $49.9 million in Q2 2024, compared to $20.6 million in Q2 2023, primarily due to ongoing clinical trials and increased personnel costs [4] - Selling, general, and administrative (SG&A) expenses rose to $103.6 million in Q2 2024 from $78.9 million in Q2 2023, driven by commercialization efforts and field force expansion [5] Net Loss and Cash Position - The net loss for Q2 2024 was $79.3 million, or $(1.67) per share, compared to a net loss of $67.2 million, or $(1.54) per share, in Q2 2023 [6] - Cash and cash equivalents totaled $315.7 million as of June 30, 2024, down from $386.2 million at the end of 2023 [6] Commercial Highlights - Approximately 123,000 prescriptions for Auvelity were written in Q2 2024, representing a 29% sequential increase from Q1 2024 [7] - Payer coverage for Auvelity increased to 60% of lives covered as of August 1, 2024, up from 48% in the previous quarter [7] - Sunosi had approximately 45,000 prescriptions written in Q2 2024, an 8% increase from Q1 2024, with 95% payer coverage in the commercial channel [8] Development Pipeline - The NDA for AXS-07 in migraine has been resubmitted, with expectations for a Class 2 designation and a six-month review [2][11] - Topline results for several Phase 3 trials, including AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD, are anticipated in the second half of 2024 [2][19] - The NDA submission for AXS-14 in fibromyalgia is expected in Q3 2024 [2][18] Business Update - Axsome resolved patent litigation with Unichem Laboratories regarding a generic version of Sunosi, allowing Unichem to market its product starting June 30, 2042, or earlier under certain conditions [17]