Axsome Therapeutics Announces Q2 2024 Financial Results and Business Update

Axsome Therapeutics, Inc., a biopharmaceutical company specializing in therapies for central nervous system (CNS) disorders, reported its financial results for the second quarter of 2024. The company announced significant growth and progress across its product lines and clinical trials.

Axsome's total net product revenue for Q2 2024 reached $87.2 million, marking an 87% increase compared to the same quarter in 2023. Specifically, Auvelity® generated $65.0 million in net product sales, representing a 135% year-over-year growth. Sunosi® contributed $22.1 million in net product revenue, reflecting a 16% increase from the previous year.

The company's R&D expenses for the second quarter were $49.9 million, up from $20.6 million in the same period of 2023. This rise was attributed to the initiation and continuation of multiple Phase 3 trials, including those for solriamfetol in major depressive disorder (MDD), ADHD, and binge eating disorder, as well as ongoing studies for AXS-05 and AXS-12. SG&A expenses also saw an increase, reaching $103.6 million, primarily due to commercialization efforts and organizational growth.

Significant milestones were achieved in Axsome's product pipeline. The New Drug Application (NDA) for AXS-07, aimed at treating migraines, was resubmitted. The company is on track to submit the NDA for AXS-14 in fibromyalgia by the third quarter. The FOCUS Phase 3 trial for solriamfetol in ADHD is expected to deliver topline results in the second half of 2024. Additionally, the ADVANCE-2 and ACCORD-2 Phase 3 trials for AXS-05 in Alzheimer's disease agitation have reached critical stages, with topline results anticipated later this year.

Auvelity saw approximately 123,000 prescriptions written in Q2 2024, a 29% sequential increase from the first quarter. Payer coverage for Auvelity in the commercial channel rose to 60% by August 1, with total coverage across all channels reaching 76%. Sunosi also showed growth, with around 45,000 prescriptions in the U.S., an 8% increase from the previous quarter. Payer coverage for Sunosi remains robust at 95% in the commercial channel and 83% across all channels.

Axsome is advancing a diverse neuroscience pipeline targeting nine serious psychiatric and neurologic conditions. Here are some key updates:

AXS-05: This drug is being developed for Alzheimer's disease agitation and smoking cessation. Two Phase 3 trials, ADVANCE-2 and ACCORD-2, are ongoing, with topline results expected in the second half of 2024.

AXS-07: Resubmission of the NDA for AXS-07 for acute migraine treatment has been completed. The company anticipates topline results from the EMERGE Phase 3 trial in the latter half of 2024.

AXS-12: This drug is under development for narcolepsy, with topline results from a Phase 3 open-label safety extension trial expected in the fourth quarter of 2024.

AXS-14: The NDA for AXS-14 for fibromyalgia management is expected to be submitted in the third quarter of 2024.

Solriamfetol: This drug is being tested for multiple indications, including ADHD, MDD, binge eating disorder, and shift work disorder. The FOCUS Phase 3 trial for ADHD is ongoing, with results anticipated in the second half of 2024.

Axsome's commercial success and extensive R&D efforts underscore its commitment to addressing CNS disorders. The company's current cash position is deemed sufficient to fund its operations into cash flow positivity, based on the existing operating plan. 

In business developments, Axsome resolved patent litigation with Unichem Laboratories Ltd., allowing the latter to market a generic version of Sunosi in the U.S. starting June 30, 2042, subject to potential extension for pediatric exclusivity.

Axsome continues to make significant strides in its product pipeline and commercial operations, aiming to provide new therapeutic options for CNS disorders.

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