• Collaboration Revenue: $13.8 million in the first quarter of 2025, a 21% increase from the fourth quarter of 2024.
• R&D Expenses: $22.8 million in Q1 2025, a 68% decrease compared to the same period in 2024, and a nearly 40% decrease compared to Q4 2024.
• SG&A Expenses: $57.6 million in the first quarter of 2025.
• Net Loss: $62.2 million for the first quarter of 2025, compared to $95.8 million in the fourth quarter of 2024.
• Cash Equivalents and Marketable Securities: $424 million as of March 31, 2025.
• ZURZUVAE Prescriptions: Greater than 3,000 prescriptions in Q1 2025, a 22% increase from Q4 2024.
• Prescriber Trends: Almost 80% of prescriptions from OBGYNs.

• Warning! GuruFocus has detected 6 Warning Signs with SAGE.

Release Date: April 29, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Sage Therapeutics Inc (NASDAQ:SAGE) reported a 22% increase in ZURZUVAE shipments in Q1 2025 compared to Q4 2024, indicating strong demand growth.
• The company achieved a 21% increase in collaboration revenue from ZURZUVAE, totaling $13.8 million in Q1 2025.
• SAGE has completed its salesforce expansion, which is expected to drive further growth in ZURZUVAE prescriptions.
• The company has a strong cash position with $424 million in cash equivalents and marketable securities, supporting operations until mid-2027.
• SAGE's R&D expenses decreased by 68% year-over-year in Q1 2025, reflecting successful cost management and restructuring efforts.

Negative Points

• SAGE reported a net loss of $62.2 million for Q1 2025, although this was an improvement from the previous quarter.
• There are ongoing uncertainties regarding the strategic alternatives process, with no set timetable for completion.
• Despite strong growth, there are challenges in achieving broader adoption of ZURZUVAE as the standard of care for postpartum depression.
• The company faces potential hurdles in advancing its pipeline, particularly with SAGE-324, which is under evaluation for future development.
• There is a need for continued investment in promotional efforts to increase awareness and adoption of ZURZUVAE among healthcare providers.

Q & A Highlights

Q: What kind of early pull-through are you seeing from your salesforce initiatives? A: Mike Quirk, Chief Scientific Officer, noted that they had a strong first quarter with over 20% growth in both demand and revenue. The salesforce expansion is complete, and they expect continued quarter-on-quarter revenue growth throughout the year. Chris Benecchi, Chief Operating Officer, added that the strategic decision to expand the sales organization aimed to broaden reach and increase contact frequency with healthcare professionals, particularly OBGYNs, who are crucial in peripartum care.

Q: Could you provide some additional color on the pipeline and your upcoming catalysts, particularly regarding SAGE's confidence in the GABA and NMDAR pathways? A: Laura Gault, Chief Medical Officer, explained that they recalibrated their R&D approach to focus on drugs with appropriate pharmacology for their intended indications. Mike Quirk added that they are prioritizing neuropsychiatry and neurodevelopmental disorders, leveraging clinical insights and validations. They believe their NMDA receptor NAMs can provide similar or better efficacy than existing treatments like ketamine, with improved safety and tolerability.

Q: For prescribers and patients not using ZURZUVAE as a first-line treatment, what are the key factors, and what efforts are underway to address these? A: Laura Gault stated that more than 70% of women prescribed ZURZUVAE receive it as their first new treatment for PPD. They do not see significant obstacles to ZURZUVAE becoming a frontline treatment. Chris Benecchi mentioned that the salesforce expansion has increased reach to OBGYNs, leading to more new writers who become repeat prescribers.

Q: How should we look at inventory levels for ZURZUVAE, and when can we expect them to stabilize? A: Chris Benecchi explained that inventory levels fluctuate due to wholesalers' purchasing habits. The focus should be on demand, measured by shipments from specialty pharmacies to women with PPD. They are encouraged by the more than 3,000 shipments in the first quarter, reflecting strong uptake and interest in ZURZUVAE.

Q: What is the overall awareness of ZURZUVAE among OBGYNs and the expecting mother community, and how is screening for PPD increasing? A: Chris Benecchi reported approximately 90% aided awareness of ZURZUVAE among physicians treating PPD, which is high for this stage of launch. They are working to increase awareness through personal and non-personal promotion. There has been an uptick in screening and diagnosis among prescribers of ZURZUVAE, indicating a renewed interest in addressing PPD.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.