Axsome Therapeutics Q1 2024 Financial Results and Business Update

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company, recently reported its financial achievements for the first quarter of 2024, highlighting significant progress in both commercial sales and research and development. CEO Herriot Tabuteau emphasized the strong performance of their on-market products and advancements in their neuroscience pipeline, reflecting the company's commitment to addressing central nervous system (CNS) disorders.

For the first quarter of 2024, Axsome reported a total net product revenue of $75.0 million, a substantial 160% increase compared to the same period in 2023, which recorded $28.8 million. This impressive growth was driven by key products such as Auvelity® and Sunosi®. Auvelity® generated $53.4 million in net product sales, marking a 240% increase year-over-year, while Sunosi® contributed $21.6 million, reflecting a 64% growth.

In terms of expenses, the cost of revenue for the first quarter of 2024 was $6.3 million, down from $7.6 million in the previous year. Research and development expenses saw a significant rise to $36.8 million from $17.8 million, attributed to ongoing Phase 3 trials and preparation for new drug applications (NDAs). Selling, general, and administrative expenses also increased to $99.0 million from $74.2 million, primarily due to expanded commercialization activities.

The net loss for the quarter was $68.4 million, or $1.44 per share, compared to a net loss of $11.2 million, or $0.26 per share, in the same period of 2023. The higher net loss this year includes $21.0 million in non-cash charges, while the previous year benefited from a $62.0 million gain from out-licensing Sunosi in Europe and the Middle East.

Axsome's cash and cash equivalents totaled $331.4 million as of March 31, 2024, down from $386.2 million at the end of 2023. The company believes its current cash reserves are sufficient to support operations until reaching cash flow positivity.

Commercially, approximately 95,000 prescriptions for Auvelity® were written in the first quarter of 2024, a 12% increase from the previous quarter. Coverage remains stable, with 70% of lives covered across all channels. Axsome has also entered a contract with a second large group purchasing organization (GPO) to potentially extend formulary coverage for Auvelity®.

For Sunosi®, about 42,000 prescriptions were written in the U.S. during the first quarter, a slight decrease from the previous quarter. Despite this, Sunosi® continues to enjoy broad payer coverage, with 95% of commercial lives covered.

Axsome's development pipeline remains robust, with significant progress in several key programs. The company reported positive Phase 3 trial results for AXS-12 in narcolepsy and initiated pivotal trials for solriamfetol in major depressive disorder and binge eating disorder. Additionally, Axsome is preparing to resubmit the NDA for AXS-07 in migraine and submit the NDA for AXS-14 in fibromyalgia in the second quarter of 2024.

AXS-05, another critical asset, is being evaluated in multiple trials for Alzheimer’s disease agitation and smoking cessation. The ADVANCE-2 Phase 3 trial is expected to complete in the second half of 2024, and the ACCORD-2 trial aims to finish enrollment by mid-year.

In summary, Axsome Therapeutics has demonstrated a strong start to 2024, marked by significant financial growth and substantial advancements in its CNS-focused product pipeline. With strategic commercial and developmental initiatives, the company is well-positioned to continue its trajectory of growth and innovation in treating CNS disorders.

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