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Mar 31, 2023
Sage Q1 2023 Earnings Report
Sage reported first quarter 2023 financial results and highlighted pipeline and business progress.
Key Takeaways
Sage Therapeutics reported a net revenue of $3.3 million from ZULRESSO sales in Q1 2023, compared to $1.6 million in the same period of 2022. The company's cash, cash equivalents, and marketable securities totaled $1.1 billion as of March 31, 2023. The FDA accepted the filing of an NDA for zuranolone for the treatment of MDD and PPD with a PDUFA action date of August 5, 2023.
NDA for zuranolone in the treatment of MDD and PPD under priority review by FDA with a PDUFA date of August 5, 2023.
Sage and Biogen progressing key commercial preparations to support a potential launch of zuranolone in late 2023, following DEA scheduling period, if approved.
Continued progress across pipeline with nine studies advancing across neuropsychiatry and neurology.
Data demonstrating severe economic burden associated with depression presented at the Academy of Managed Care Pharmacy and The Professional Society for Health Economics and Outcomes Research.
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
- Potential to achieve milestones totaling $225.0 million from Biogen related to first commercial sales of zuranolone for the treatment of MDD and PPD in the U.S., if approved.
- Existing cash, cash equivalents and marketable securities, anticipated funding from ongoing collaborations, and potential revenue, will support its operations into 2025.
Challenges Ahead
- R&D and SG&A spending to increase as it prepares for the potential launch of zuranolone.
- Spending will increase as the company advances planned and ongoing studies for SAGE-718 and SAGE-324.
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