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Dec 31, 2022
Sage Q4 2022 Earnings Report
Sage reported results for Q4 2022, highlighting pipeline advancements and regulatory progress for zuranolone.
Key Takeaways
Sage Therapeutics reported fourth quarter and full year 2022 financial results, with a focus on advancing the regulatory path for zuranolone in MDD and PPD. The FDA accepted the NDA filing for zuranolone and granted Priority Review. The company's pipeline is progressing with nine studies across neuropsychiatry and neurology in 2023. Year-end cash, cash equivalents, and marketable securities totaled $1.3 billion, expected to support operations into 2025.
FDA accepted the NDA filing for zuranolone and granted Priority Review in the treatment of MDD and PPD.
Robust pipeline advancing nine studies across neuropsychiatry and neurology in 2023.
Year-end 2022 cash, cash equivalents and marketable securities of $1.3 billion, expected to support operations into 2025.
Net revenue from sales of ZULRESSO was $2.9 million in the fourth quarter of 2022.
Forward Guidance
Sage anticipates that its existing cash, cash equivalents and marketable securities, anticipated funding from ongoing collaborations, and potential revenue, will support its operations into 2025. The Company anticipates R&D and SG&A spending to increase as it prepares for the potential launch of zuranolone and advances planned and ongoing studies for SAGE-718 and SAGE-324.
Positive Outlook
- Existing cash, cash equivalents and marketable securities are expected to support operations into 2025.
- Anticipated funding from ongoing collaborations will support operations.
- Potential revenue will support operations.
- Potential to achieve milestones totaling $225.0 million from Biogen related to first commercial sales of zuranolone in MDD and PPD in the U.S., if approved.
- Advancing planned and ongoing studies for SAGE-718 and SAGE-324.
Challenges Ahead
- R&D spending is anticipated to increase.
- SG&A spending is anticipated to increase.
- Preparing for the potential launch of zuranolone will increase spending.
Historical Earnings Impact
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