Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - Axsome Therapeutics reported strong financial results for Q4 and full year 2024, with total net product revenue of $118.8 million and$385.7 million, reflecting year-over-year growth of 66% and 88% respectively [5] - The company achieved significant sales growth for its products, particularly Auvelity, which saw Q4 sales of $92.6 million, a 89$291.4 million, a 124% increase [5] - The approval of Symbravo for migraine treatment and advancements in the clinical pipeline, including AXS-05 for Alzheimer's disease agitation and AXS-12 for narcolepsy, position the company for continued growth [4][11] Financial Performance - Total net product revenues for Q4 2024 were $118.8 million, up from$71.5 million in Q4 2023, while full year revenues reached $385.7 million compared to$204.9 million in 2023 [5] - Auvelity's net product sales for Q4 2024 were $92.6 million, compared to$49.0 million in Q4 2023, and for the full year, sales were $291.4 million versus$130.1 million in 2023 [5] - Sunosi generated net product revenues of $26.2 million in Q4 2024 and$94.3 million for the full year, representing year-over-year growth of 16% and 26% respectively [5] Research and Development - Axsome completed the Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation and plans to submit a New Drug Application (NDA) in the second half of 2025 [4][15] - Positive topline results from the ENCORE Phase 3 trial of AXS-12 in narcolepsy were announced, with an NDA submission anticipated in the second half of 2025 [4][18] - The company is on track to report topline results from the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and major depressive disorder, respectively, in Q1 2025 [4][16] Commercial Highlights - Approximately 158,000 prescriptions for Auvelity were written in Q4 2024, marking an 87% increase from Q4 2023 [10] - Payer coverage for Auvelity is approximately 78% across all channels, with 63% in commercial and 100% in government channels [10] - Sunosi prescriptions reached approximately 49,000 in Q4 2024, a 16% increase from the same period in 2023, with payer coverage at 83% [10] Corporate Developments - Axsome entered into a settlement agreement resolving patent litigation related to Auvelity, allowing Teva to market a generic version starting in 2038 or 2039, depending on pediatric exclusivity [20] - The company has a strong cash position of $315.4 million as of December 31, 2024, down from$386.2 million a year earlier, which is expected to fund operations into cash flow positivity [6][29]