Loading...
•
Jun 30, 2021
Axsome Q2 2021 Earnings Report
Axsome reported financial results for the second quarter ended June 30, 2021.
Key Takeaways
Axsome Therapeutics reported a net loss of $32.3 million, or $(0.86) per share, for the three months ended June 30, 2021. The FDA notified Axsome that they have identified deficiencies that preclude labeling discussions for AXS-05.
FDA identified deficiencies that preclude labeling discussions for AXS-05
NDA for AXS-07 for the acute treatment of migraine was submitted in the second quarter
Phase 3 trial of AXS-12 for the treatment of narcolepsy is on track to initiate in the third quarter
Completed a pre-NDA meeting with the FDA for AXS-14
Axsome
Axsome
Forward Guidance
Axsome believes that its cash at June 30, 2021, along with the remaining committed capital from the $225 million term loan facility, is sufficient to fund anticipated operations into at least 2024. Axsome expects that its operating expenses will increase year over year as they continue to build out the commercial function and further advance their pipeline.
Positive Outlook
- Cash is sufficient to fund operations into at least 2024
- Remaining committed capital from the $225 million term loan facility will support operations
- Focus on commercial launch of AXS-05 in MDD
- Potential commercial launch of AXS-07 in migraine
- Advancement of pipeline
Challenges Ahead
- Uncertainty regarding FDA approval of AXS-05
- Potential delays in AXS-05 approval due to identified deficiencies
- Increased operating expenses year over year
- Dependence on successful commercial launch of AXS-05 and AXS-07
- Potential impact of unforeseen circumstances or disruptions related to COVID-19