Axsome's AXS-05 In Alzheimer's Agitation Could Be Billion Dollar Opportunity, Says Analyst

On Tuesday, Axsome Therapeutics Inc AXSM reported fourth-quarter 2024 revenues of $118.77 million, up from $71.53 million a year ago, beating the consensus of $117.64 million.

Auvelity (oral antidepressant) net product sales for the quarter were $92.6 million, up 89% year over year. Approximately 158,000 prescriptions were written for Auvelity in the fourth quarter of 2024, representing an increase of 87% and 10% compared to the third quarter of 2024.

Sunosi (sleep disorder) net product revenues were $26.2 million, up 16%. Approximately 49,000 prescriptions were written for Sunosi, representing an increase of 16% year-over-year and 4% sequentially.

Also Read: Axsome Therapeutics Resolves Generic Patent Litigation With Teva Over Depression Drug, Analyst Maintains Axsome As ‘Top Pick For 2025’

The company reported a net loss of $1.54 per share compared to $2.08 per share a year ago, missing the consensus of $(1.03).

Anticipated Milestones

• The company expects to submit a new drug application for AXS-14 for fibromyalgia in the first half of 2025, a delay from November 2024.
• Axsome anticipates new drug application submission for AXS-05 for Alzheimer’s disease agitation and AXS-12 for narcolepsy in the second half of 2025.
• The company expects clinical data from a Phase 3 EMERGE trial of AXS-07 in migraine in 1Q 2025.
• Data from Phase 3 FOCUS trial of solriamfetol in ADHD in adults and Phase 3 PARADIGM trial in major depressive disorder in Q1 2025.
• The company anticipates data from the Phase 3 ENGAGE trial of solriamfetol in binge eating disorder and the Phase 3 SUSTAIN trial in shift work disorder in 2026.
• A pivotal Phase 2/3 trial of AXS-05 in smoking cessation is expected to be initiated in 2025.

In January, the FDA approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.

The company expects SYMBRAVO to be commercially available in the U.S. in approximately four months.

William Blair sees Axsome’s AXS-05 as a unique drug with strong safety advantages. Analyst Myles Minter is optimistic about its approval chances, citing positive results from the ADVANCE-1, ACCORD-1, and ACCORD-2 trials and its breakthrough therapy designation.

With peak sales expected to surpass $1 billion for Alzheimer ‘s-related agitation, William Blair considers this expansion a major growth driver for Axsome. The firm also notes potential M&A interest, especially given Johnson & Johnson’s JNJ pending $14.6 billion acquisition of Intra-Cellular Therapies Inc ITCI.

Price Action: AXSM shares are down 3% at $127.22 on the last check Tuesday.

Read Next:

• TotalEnergies Powers Up With Air Liquide For Hydrogen Breakthrough