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Dec 31, 2021
Axsome Q4 2021 Earnings Report
Axsome reported financial results for Q4 and full year 2021 and provided a business update.
Key Takeaways
Axsome Therapeutics reported a net loss of $34.0 million for the fourth quarter of 2021, compared to a net loss of $29.2 million for the same period in 2020. The company's R&D expenses were $13.8 million, and G&A expenses were $18.8 million. The company anticipates potential launches for AXS-05 and AXS-07.
FDA review of NDA for AXS-05 in depression is progressing.
PDUFA date for NDA for AXS-07 in the acute treatment of migraine is approaching on April 30, 2022.
Topline results from Phase 3 trials of AXS-12 in narcolepsy and AXS-05 in Alzheimer’s disease agitation are anticipated in 2023.
The AXS-05 field force team build is essentially complete with all signed offers contingent upon approval.
Axsome
Axsome
Forward Guidance
Axsome believes its current cash, along with the remaining committed capital, is sufficient to fund anticipated operations into 2024 and expects that operating expenses will increase year over year as it continues to build out the commercial function and further advance its pipeline.
Positive Outlook
- Current cash is sufficient to fund operations into 2024.
- Remaining committed capital from the term loan facility available.
- Potential commercial launch of AXS-05 in MDD.
- Potential commercial launch of AXS-07 in migraine.
- Ongoing build-out of the commercial function.
Challenges Ahead
- Operating expenses are expected to increase year over year.
- Continued advancement of the pipeline will increase expenses.
- Uncertainties regarding regulatory approvals.
- Potential delays in clinical trials.
- Market acceptance of product candidates is not guaranteed.