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Jun 30, 2022
Sage Q2 2022 Earnings Report
Reported business highlights and financial results.
Key Takeaways
Sage Therapeutics reported its Q2 2022 financial results, featuring progress on the NDA submission for zuranolone and advancements in their clinical pipeline. The company's cash is expected to support operations into 2025.
Rolling NDA submission for zuranolone in MDD and PPD remains on track, with completion expected in the second half of 2022.
Positive topline data was announced from the Phase 3 SKYLARK Study evaluating 50 mg zuranolone for PPD.
Multiple Phase 2 studies are enrolling across neuropsychiatry and neurology franchises, with additional trials expected to initiate throughout 2022.
Cash and cash equivalents, anticipated funding from ongoing collaborations, and potential revenue, are expected to support operations into 2025.
Forward Guidance
Sage anticipates cash, cash equivalents and marketable securities of approximately $1.3 billion at the end of 2022. The Company anticipates R&D and SG&A spending to increase as it advances planned and ongoing studies for SAGE-718 and SAGE-324 and prepares for the potential launch of zuranolone.
Positive Outlook
- Complete NDA submission for zuranolone in MDD and PPD (2H 2022).
- Present additional zuranolone data throughout 2022.
- Initiate a Phase 3 safety study of SAGE-718 in people with HD cognitive impairment.
- Initiate a placebo-controlled Phase 2 study of SAGE-718 in people with mild cognitive impairment and mild dementia due to AD.
- Complete enrollment in KINETIC 2 Study of SAGE-324 in ET.
Challenges Ahead
- Sage anticipates cash, cash equivalents and marketable securities of approximately $1.3 billion at the end of 2022.
- The Company does not anticipate receipt of any milestone payments from collaborations in 2022.
- R&D and SG&A spending to increase as it advances planned and ongoing studies for SAGE-718 and SAGE-324
Historical Earnings Impact
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