Axsome Therapeutics (AXSM) The 44th Annual William Blair Growth Stock Conference summary

Key product updates and commercial performance

• Auvelity, a novel antidepressant, achieved $130 million in its first full year and is on a strong growth trajectory, with current annualized sales at $200 million and increasing first- and second-line usage to 50%.

• Sunosi, targeting excessive daytime sleepiness, maintains steady growth and is being explored for additional indications.

• Expanded sales force became fully productive in Q1 2024, expected to drive further prescription growth throughout 2024.

• Patient access for Auvelity is improving, with commercial coverage at 48-50% and total coverage at 70%, supported by new group purchasing contracts.

• Peak sales estimate for Auvelity is $1-3 billion, driven by a large market and increasing adoption in earlier treatment lines.

Pipeline and clinical development milestones

• Late-stage pipeline includes AXS-05 (Alzheimer’s agitation), AXS-07 (migraine), AXS-12 (narcolepsy), and AXS-14 (fibromyalgia), with potential for six marketed indications by 2025.

• AXS-05 has completed two positive phase 3 trials for Alzheimer’s agitation; two more phase 3 trials are ongoing, with top-line results expected in H2 2024.

• AXS-07 NDA resubmission for migraine is planned for this quarter after addressing manufacturing issues.

• AXS-12 showed positive phase 3 results in narcolepsy; open-label safety extension to complete by year-end, with NDA preparation to follow.

• AXS-14 demonstrated significant efficacy in fibromyalgia; NDA submission expected in H2 2024.

• Solriamfetol (Sunosi) is in phase 3 trials for ADHD, major depressive disorder, binge eating disorder, and shift work disorder, with multiple data readouts expected in late 2024 and 2025.

Market opportunities and differentiation

• AXS-05 offers a differentiated safety profile for Alzheimer’s agitation compared to antipsychotics, with rapid and substantial symptom improvement.

• AXS-14 addresses unmet needs in fibromyalgia, showing significant improvements in pain, function, and fatigue, with strong patient and clinician feedback.

• Total U.S. peak sales potential for the CNS pipeline is estimated at $16.5 billion.