Neurology-Focused Axsome Therapeutics Reports Deeper Than Expected Q4 Loss, Updates Upcoming Pipeline Milestones

Axsome Therapeutics Inc AXSM reported fourth-quarter 2023 revenues of $71.53 million, up from $24.37 million a year ago, beating the consensus of $67.69 million.

Auvelity (oral antidepressant) net product sales were $49 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch. 

Approximately 84,000 prescriptions were written for Auvelity in the fourth quarter of 2023, representing a 23% sequential increase.

Sunosi (sleep disorder) net product revenues were $22.5 million and $74.8 million for the fourth quarter and full year of 2023, representing 17% and 67% Y/Y growth, respectively.

Also Read: UBS Bullish On This Depression Drug Maker, Says Alzheimer’s Agitation Data Is Attractive Catalyst.

Approximately 42,000 prescriptions were written for Sunosi in the U.S. in the fourth quarter of 2023, representing an 18% increase versus the fourth quarter of 2022 and a 2% sequential increase versus the third quarter of 2023.

The company reported a net loss of $(2.08) compared to $(1.41) per share a year ago, missing the consensus of $(1.15).

The net loss in the fourth quarter of 2023 includes $63.7 million in non-cash charges, comprised of $43.2 million in acquisition-related contingent consideration expense reflecting updated sales projections for the recently announced new indications in solriamfetol.

Anticipated Milestones

• The company expects new drug application submission for AXS-14 for fibromyalgia in the first half of 2024 versus the first quarter of 2024 expected earlier.
•  Axsome anticipates clinical topline results from Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation in the second half of 2024 versus the first half of 2024 expected earlier.
•  The company expects to initiate a Phase 3 trial of solriamfetol in major depressive disorder (MDD) in the first quarter of 2024.
•  Phase 3 trial of solriamfetol for binge eating disorder (BED) is anticipated to start in the first quarter of 2024 versus the fourth quarter of 2023, anticipated earlier.

Price Action: AXSM shares are down 12.60% at $81.14 on the last check Tuesday.

Photo by Gerd Altman via PIxabay