Axsome Therapeutics (AXSM) Q3 Earnings call transcript Nov 12, 2024

In the third quarter of 2024, Axsome Therapeutics reported a robust financial performance, with total net product revenue reaching $104.8 million, marking an impressive 81% year-over-year increase. This success is attributed to the strong sales momentum of Auvelity and Sunosi, which recorded net product sales of $80.4 million and $24.4 million, respectively. The company's revenue run rate now stands at approximately $420 million, underscoring its significant growth trajectory.

Innovative Pipeline and Strategic Focus

Axsome's strategic focus on developing novel, innovative medicines for central nervous system conditions is evident in its diverse pipeline, which includes five late-stage product candidates in development across psychiatry and neurology. The potential impact of these candidates on over 150 million patients in the U.S. is significant, with a combined peak sales potential of over $16 billion. The company's approach to scientific innovation aligns with its patient-centric mission, positioning it to address unmet needs and expand therapeutic possibilities.

Regulatory Milestones and Commercial Success

Axsome's pipeline boasts several milestones, including the resubmission of the new drug application for AXS-07, a novel, multi-mechanistic product candidate for the acute treatment of migraine, and the ongoing EMERGE Phase III trial evaluating its efficacy in patients with a prior inadequate response to oral CGRP antagonists. The company is also preparing for the potential launch of AXS-07, which has the potential to address the unmet needs of migraine patients.

The commercial success of Auvelity and Sunosi is a testament to Axsome's strategic focus and operational excellence. Auvelity's strong sales performance, with over 140,000 new patients started on the treatment since launch, underscores its value to patients and healthcare providers. Sunosi's steady growth, with 47,000 prescriptions in the third quarter, highlights its potential in addressing sleep-related disorders.

Looking Ahead

Axsome's future outlook is promising, with several late-stage assets in development and commercialization plans for AXS-07 on the horizon. The company's strategic focus, operational efficiency, and robust financial position position it well for continued growth and value creation for patients and shareholders. As Axsome Therapeutics continues to innovate and deliver novel treatments, it is poised to transform the lives of millions of patients living with central nervous system conditions.