Sage Therapeutics Reports First Quarter 2025 Financial Results, Showcases Strong Momentum for ZURZUVAE and Pipeline Advancements
Sage Therapeutics, Inc. (Nasdaq: SAGE) has announced its financial results for the first quarter ended March 31, 2025, highlighting solid progress in the commercialization of ZURZUVAE for postpartum depression (PPD), steady advancement in its pipeline, and a continued focus on long-term strategic opportunities.
Barry Greene, Chief Executive Officer at Sage Therapeutics, commented on the quarter’s results:
“We delivered strong growth in revenue and shipments of ZURZUVAE during the first quarter of 2025 through the team’s disciplined execution and unwavering commitment to bringing ZURZUVAE to more women with postpartum depression. We remain focused on establishing ZURZUVAE as the standard of care for women with postpartum depression and driving our business strategy forward with the goal of creating value for shareholders.”
Commercial and Pipeline Highlights
ZURZUVAE: Driving Commercial Growth in Postpartum Depression
ZURZUVAE (zuranolone), the first-and-only oral treatment approved by the U.S. Food and Drug Administration (FDA) for adults with postpartum depression, continues to gain market traction since its commercial launch in December 2023. Initially approved in August 2023, ZURZUVAE represents a major breakthrough for women suffering from PPD—a condition that affects one in eight women after childbirth.
In the first quarter of 2025, Sage reported continued strong uptake of ZURZUVAE, supported by expanded commercialization efforts conducted in collaboration with Biogen. As part of its commercialization strategy, Sage has invested in expanding the joint sales force and rolling out broader marketing and disease awareness campaigns aimed at increasing both diagnosis and treatment of PPD.
Key performance metrics from Q1 2025 include:
- More than 3,000 prescriptions shipped to women diagnosed with postpartum depression, marking a 22% increase compared to the fourth quarter of 2024.
- $13.8 million in collaboration revenue recognized, reflecting a 21% quarter-over-quarter increase. This revenue represents 50% of net sales recognized by Biogen, ZURZUVAE’s co-commercialization partner.
Notably, prescribing trends continue to support the product’s clinical and commercial potential:
- OBGYNs accounted for nearly 80% of all prescriptions in the first quarter, a promising signal given the central role these specialists play in managing postpartum care.
- Physicians who have prescribed ZURZUVAE are increasingly treating more patients with PPD, suggesting growing confidence in its therapeutic value.
- Over 70% of women prescribed ZURZUVAE in Q1 received it as their first new treatment, reinforcing the unmet need for fast-acting, convenient treatment options.
With continued investment in awareness and access initiatives, Sage believes ZURZUVAE is well positioned to become the standard of care in postpartum depression treatment.
Advancing the Pipeline: Focus on Neuroscience Innovation
Beyond its commercial efforts, Sage continues to develop a pipeline of novel neuroscience candidates designed to address unmet needs in neuropsychiatric and neurodevelopmental disorders.
SAGE-319: A Promising Candidate in Neurodevelopmental Disorders
SAGE-319, an extrasynaptic-preferring GABAA receptor positive allosteric modulator (PAM), is currently being evaluated as a potential treatment for behavioral symptoms associated with certain neurodevelopmental conditions. Its pharmacological profile is designed to offer differentiation from other GABAA receptor PAMs in Sage’s portfolio.
The compound is currently in a Phase 1 multiple ascending dose (MAD) study, with data anticipated in late 2025. Sage will assess future development plans based on these results, which are expected to provide key insights into safety, tolerability, and pharmacodynamics.
Preclinical Pipeline: NMDA NAM Programs
In the preclinical arena, Sage is advancing targeted work within its NMDA receptor negative allosteric modulator (NAM) platform. Key compounds include SAGE-817 and SAGE-039, which are being explored for their potential in treating neurodevelopmental disorders. These programs remain in the exploratory stages but highlight the company’s continued commitment to innovation in central nervous system (CNS) disorders.
SAGE-324: Strategic Evaluation Underway
Sage is also evaluating potential future indications for SAGE-324, including seizures related to developmental and epileptic encephalopathies (DEEs). The company expects to provide an update regarding the direction of this program by mid-2025 as it continues to assess the clinical and commercial viability.
Strategic Review Process
Sage’s Board of Directors continues to evaluate a broad range of strategic alternatives with the goal of enhancing long-term shareholder value. The review process was previously announced and remains active, although no specific timetable has been set. Sage has stated that it does not intend to provide further updates on the process until a definitive course of action is determined.
This ongoing evaluation underscores the company’s focus on maximizing the potential of its assets, both commercial and developmental, through organic growth and potential partnerships, asset sales, or strategic transactions.
First Quarter 2025 Financial Results
Revenue Growth Driven by ZURZUVAE
For the quarter ended March 31, 2025, Sage reported $13.8 million in collaboration revenue, more than doubling the $6.2 million reported in Q1 2024. This revenue reflects Sage’s share of net sales recorded by Biogen under their collaboration for ZURZUVAE.
There was no revenue from ZULRESSO in Q1 2025, compared to $1.7 million in Q1 2024, as commercial efforts have shifted entirely to ZURZUVAE.
Research and Development (R&D) Expenses
R&D expenses totaled $22.8 million in Q1 2025, a significant reduction from $71.7 million in Q1 2024. The decrease reflects the impact of cost-saving measures implemented through reorganizations in 2023 and 2024, which included staff reductions, reprioritization of early-stage programs, and the completion or cancellation of select clinical trials.
Included in the R&D total was $2.1 million in non-cash stock-based compensation. Biogen’s reimbursement for Sage’s R&D under their collaboration agreement amounted to $0.2 million, compared to $5.7 million in Q1 2024, reflecting fewer clinical development activities.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses were $57.6 million in Q1 2025, up from $52.6 million in Q1 2024. The increase was largely driven by enhanced commercialization efforts for ZURZUVAE and legal expenses related to the strategic alternatives review process.
Non-cash stock-based compensation within SG&A was $4.9 million. Reimbursement from Sage to Biogen for SG&A collaboration costs was $4.8 million, up from $2.3 million in the year-ago period.
Other Financial Metrics
- Cost of revenues was $0.7 million in Q1 2025, down from $1.3 million in Q1 2024, reflecting the focus on ZURZUVAE.
- Restructuring expenses were $0.5 million in the quarter, tied to the October 2024 reorganization.
- Net loss narrowed significantly to $62.2 million in Q1 2025, compared to a net loss of $108.5 million in Q1 2024.
Cash Position and Financial Outlook
As of March 31, 2025, Sage reported $424 million in cash, cash equivalents, and marketable securities, down from $504 million at the end of 2024. Despite the ongoing commercialization investment in ZURZUVAE, the company expects its cash runway to support operations through mid-2027, based on its current operating plan.
The company anticipates that overall operating expenses will decline significantly in 2025 compared to 2024, even as commercialization investments in ZURZUVAE increase.
Sage Therapeutics enters the remainder of 2025 with a sharpened focus on three key priorities: driving continued growth for ZURZUVAE, advancing promising neuroscience assets in its pipeline, and exploring strategic opportunities to unlock long-term value. With encouraging early trends in commercial performance and a leaner cost structure, the company believes it is well positioned to deliver meaningful impact for patients and stakeholders alike.
