Axsome Q1 2022 Earnings Report
Key Takeaways
Axsome Therapeutics reported a net loss of $39.6 million, or $(1.03) per share, for the first quarter ended March 31, 2022. The company's R&D expenses were $12.6 million, while G&A expenses were $25.7 million. Axsome had $84.7 million in cash as of March 31, 2022 and anticipates potential FDA action on the NDA in the second quarter of 2022.
NDA for AXS-05 in depression is under review with potential FDA action expected in Q2 2022.
Acquisition of Sunosi is expected to close in Q2 2022 for the U.S. transaction.
NDA resubmission for AXS-07 in migraine is planned following engagement with the FDA.
Topline results from Phase 3 trials of AXS-12 in narcolepsy and AXS-05 in Alzheimer’s disease agitation are anticipated in 2023.
Axsome
Axsome
Forward Guidance
Axsome believes its current cash, along with the remaining committed capital from the $300 million term loan facility, is sufficient to fund anticipated operations into 2024. The company expects that its 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 $300 million term loan facility will support operations.
- Potential launch of AXS-05 in MDD is included in the operating plan.
- Acquisition and commercialization of Sunosi is included in the operating plan.
- Sunosi acquisition U.S. and ex-U.S. transaction closings (2Q, 3Q 2022, respectively)
Challenges Ahead
- Operating expenses will increase year over year.
- Building out the commercial function will increase expenses.
- Further advancing the pipeline will increase expenses.
- Received a Complete Response Letter (CRL) from the FDA regarding its NDA for AXS-07
- Net loss of $39.6 million for the three months ended March 31, 2022