- **ZURZUVAE Momentum**: Q1 2025 shipments up 22% QoQ, surpassing 10,000 cumulative women treated. Collaboration revenue $13.8M (+21% QoQ).
- **Cost Efficiency**: Net loss reduced to $62.2M (vs. $95.8M prior quarter), driven by 68% YoY R&D expense decline.
- **Pipeline Focus**: SAGE-319 Phase 1 data expected late 2025; NMDA NAMs targeting safer alternatives to ketamine.
- **Strategic Flexibility**: $424M cash runway to mid-2027; Board evaluating value-maximizing alternatives.


**【CEO Summary Section】**
- ZURZUVAE shipments reached 3,000+ in Q1 2025, a 22% QoQ increase, with $13.8M collaboration revenue (50% of Biogen's net revenue). Cumulative shipments exceed 10,000 women with PPD.
- Sage's Board continues evaluating strategic alternatives to maximize shareholder value.
- R&D restructured to focus on neuropsychiatry and neurodevelopmental disorders, with cost reductions (e.g., Q1 R&D expenses down 68% YoY).
- Cash runway extended to mid-2027 with $424M as of Q1 2025.

**【CFO Financial Commentary】**
- Q1 2025 net loss: $62.2M (vs. $95.8M in Q4 2024), driven by cost savings from R&D restructuring.
- Collaboration revenue growth: 21% QoQ to $13.8M, reflecting ZURZUVAE adoption.
- SG&A expenses: $57.6M (aligned with ZURZUVAE commercialization investments).
- Operating expenses expected to decrease YoY 2025 due to R&D cost reductions.

**【Pipeline Updates】**
- **SAGE-319**: Phase 1 MAD study results expected late 2025 for neurodevelopmental disorder (e.g., autism, Tourette’s) potential.
- **NMDA receptor NAMs (SAGE-817/SAGE-039)**: Preclinical data suggest improved safety vs. ketamine; IND filings anticipated.
- **SAGE-324**: Evaluating chronic dosing in developmental epileptic encephalopathies (DEEs); decision on path forward mid-2025.

**【Q&A Highlights】**
- **Sales Force Expansion**: Complete as of Q1 2025; 80% prescriptions from OB/GYNs, with >70% women receiving ZURZUVAE as first-line treatment.
- **Gross-to-Net Ratio**: Minimal impact due to payer recognition of ZURZUVAE's novel mechanism; <1 week fill rate for 70% of prescriptions.
- **Pipeline Confidence**: GABA and NMDA pathways validated by clinical data; focus on improved tolerability profiles.
- **Strategic Alternatives**: No timeline for resolution; prioritizing ZURZUVAE growth and pipeline efficiency.


Sage Therapeutics (SAGE)-29 Apr 25-2025 Q1 Earnings call transcript

- **ZURZUVAE Commercial Success**: 6,600+ prescriptions shipped in 2024, 21% Q4 demand growth, and 70% first-line prescribing rate.
- **2025 Strategic Focus**: Expanding ZURZUVAE sales force, reducing R&D costs, and extending cash runway to mid-2027.
- **Pipeline Progress**: SAGE-319 Phase I data expected late 2025; Shionogi's MDD approval in Japan could yield $55M milestones.
- **Financial Discipline**: Q4 2024 revenue $11.4M, with 2025 operating expenses down due to reorganization savings.


**【CEO Summary Section】**
- ZURZUVAE achieved strong commercial momentum in 2024, with over 6,600 prescriptions shipped for postpartum depression (PPD), reflecting 21% Q4 demand growth.
- Sage is prioritizing three core initiatives in 2025: expanding ZURZUVAE's market share, recalibrating R&D focus on neuropsychiatric disorders, and maintaining financial discipline.
- The company rejected Biogen's unsolicited acquisition proposal, citing undervaluation, and initiated a strategic alternatives review process.

**【CFO Financial Commentary】**
- Q4 2024 collaboration revenue from ZURZUVAE was $11.4 million, up 4% from Q3, with full-year revenue of $36.1 million.
- Operating expenses are expected to decrease in 2025 due to R&D and G&A reductions, with a cash runway extending to mid-2027.
- Free drug distribution decreased in Q4, reflecting improved payer coverage and access.

**【Pipeline Update】**
- SAGE-319, a GABAA receptor PAM, is in Phase I MAD study for neurodevelopmental disorders, with target engagement data expected late 2025.
- SAGE-324, an NMDAR NAM, is being evaluated for seizures in developmental epileptic encephalopathies, with potential next steps mid-2025.
- Shionogi's MDD (major depressive disorder) application in Japan is expected to receive regulatory decision in Q3 2025, with potential $55 million in regulatory milestones upon approval.

**【Q&A Highlights】**
- Sales force expansion in Q4 2024 drove 33% growth in targeted territories, with continued investment in DTC media and social campaigns.
- ZURZUVAE is prescribed as first-line therapy in 70% of cases, with minimal retreatment due to its rapid and durable efficacy.
- Payer coverage exceeds 95% of commercial and Medicaid lives, with no significant pushback on multiple treatment courses.


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