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Sep 30, 2024

Axsome Q3 2024 Earnings Report

Axsome demonstrated strong commercial performance and advanced its late-stage development pipeline.

Key Takeaways

Axsome Therapeutics reported a total net product revenue of $104.8 million for Q3 2024, representing an 81% year-over-year growth. The company is also advancing its pipeline with multiple Phase 3 trial results expected soon and an NDA submission planned.

Total net product revenue for Q3 2024 was $104.8 million, an 81% increase year-over-year.

Auvelity net product sales were $80.4 million, representing a 113% year-over-year growth.

Sunosi net product revenue was $24.4 million, a 21% increase year-over-year.

NDA resubmission for AXS-07 for migraine was accepted by the FDA with a PDUFA goal date of January 31, 2025.

Total Revenue
$105M
Previous year: $57.8M
+81.3%
EPS
-$0.49
Previous year: -$1.32
-62.9%
R&D Expenses
$45.4M
Previous year: $28.8M
+57.8%
SG&A Expenses
$95.6M
Previous year: $83.2M
+14.9%
Shares Outstanding
48.44M
Previous year: 47.32M
+2.4%
Gross Profit
$96.3M
Previous year: $51.3M
+87.9%
Cash and Equivalents
$327M
Previous year: $417M
-21.4%
Free Cash Flow
-$18.7M
Previous year: -$53.9M
-65.3%
Total Assets
$561M
Previous year: $601M
-6.6%

Axsome

Axsome

Forward Guidance

Axsome anticipates several clinical catalysts and regulatory milestones. The company believes that its current cash is sufficient to fund anticipated operations into cash flow positivity.

Positive Outlook

  • NDA submission for AXS-14 for fibromyalgia anticipated in November 2024.
  • PDUFA goal date for AXS-07 for migraine is January 31, 2025.
  • Topline results of ADVANCE-2 and ACCORD-2 Phase 3 trials of AXS-05 in Alzheimer’s disease agitation expected in Q4 2024.
  • Topline results of ENCORE Phase 3 trial of AXS-12 in narcolepsy expected in Q4 2024.
  • Second expansion of Auvelity psychiatry sales force planned for 1Q 2025.