Axsome Therapeutics (AXSM) Reports Prelim Q4 Guidance

Axsome Therapeutics, Inc. (NASDAQ: AXSM) today announced preliminary net product revenue for the fourth quarter and full year ended December 31, 2023.

“Axsome completed its first full year as a commercial company in 2023 and, during that time, our medicines reached approximately 100,000 unique patients. Prescriptions for Auvelity and Sunosi totaled more than 236,000 and 139,000, respectively for the full year,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Looking ahead, 2024 promises to be a busy year for us with an increased field force effort that will support continued strong commercial execution with Auvelity and Sunosi. We also anticipate multiple important clinical and regulatory milestones from our industry leading neuroscience portfolio in 2024. These include topline results from Phase 3 trials in narcolepsy, Alzheimer’s disease agitation, and ADHD, NDA resubmission and submission for migraine and fibromyalgia, respectively, and initiation of Phase 3 trials in major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder. Collectively, Axsome has the potential to address conditions that impact the lives of more than 150 million patients in the U.S. We are committed to developing and delivering innovative treatments with novel mechanisms of action to address unmet medical needs in serious conditions that affect brain health.”

Preliminary Fourth Quarter and Full Year 2023 Net Product Revenue (Unaudited)

Based on preliminary unaudited financial information, Axsome expects total product revenue to be approximately $71 million and $204 million for the fourth quarter and full year of 2023, respectively.

• Auvelity^® net product sales are expected to be approximately $49 million and $130 million for the fourth quarter and full year of 2023, respectively.
• Sunosi^® net product revenue is expected to be $22 million and $74 million for the fourth quarter and full year of 2023, respectively. Net product revenue excludes $66 million in license revenue recognized by Axsome in the first quarter of 2023.

The foregoing information reflects the Company's estimate with respect to net product revenue for Auvelity and Sunosi based on currently available unaudited information. This announcement is not a comprehensive statement of Axsome’s financial results and is subject to completion of Axsome’s financial closing procedures. Axsome’s final financial results will be issued upon completion of its closing procedures and may vary from these preliminary estimates.

2024 Development Pipeline Anticipated Milestones

Axsome is advancing an industry-leading neuroscience portfolio encompassing five innovative late-stage product candidates for 10 serious conditions, which affect more than 150 million people in the U.S. alone. 2024 anticipated milestones for key pipeline programs are summarized below.

• Regulatory Milestones:
  • AXS-07 for migraine, NDA resubmission (1H 2024)
  • AXS-14 for fibromyalgia, NDA submission (1Q 2024)
• Clinical Trial Topline Results:
  • Phase 3 SYMPHONY trial of AXS-12 in narcolepsy (1Q 2024)
  • Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (1H 2024)
  • Phase 3 FOCUS trial of solriamfetol in attention deficit hyperactivity disorder (ADHD) in adults (2H 2024)
• Clinical Trial Initiations:
  • Phase 3 trial of solriamfetol in major depressive disorder (MDD) (1Q 2024)
  • Phase 3 trial of solriamfetol for binge eating disorder (BED) (1Q 2024)
  • Phase 3 trial of solriamfetol in shift work disorder (SWD) (1Q 2024)
  • Pivotal Phase 2/3 trial of AXS-05 for smoking cessation (2024)

You May Also Be Interested In

• Sanuwave Q2 2026 revenue tops revised guidance range
• DHT Holdings Q2 TCE earnings estimated at $126,700 per day
• Landstar System (LSTR) PT Raised to $186 at Stifel