Sage Therapeutics, Inc.

live on the investors and media section of Sage's website at sagerx.com. This call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded. I would now like to introduce Ashley Kaplowitz, Vice President of Investor Relations and Capital Markets at Sage.

Good afternoon, and thank you for joining Sage Therapeutics' first quarter 2025 financial results conference call. Before we begin, I encourage everyone to go to the investors and media section of our website at sagerx.com, where you can find the press release and slides related to today's call. I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional details. We will begin the call with prepared remarks by Barry Green, our Chief Executive Officer, who will provide an overview of our progress during the first quarter 2025. Our Chief Operating Officer, Chris Benucki, will provide an update on the ongoing commercialization of Zerzuve and key financial results from the first quarter 2025. Our Chief Scientific Officer and Interim Head of R&D, Mike Quirk, will then provide a brief update on our pipeline. With that, I'll now turn the call over to Barry.

Thanks, Ashley, and thank you, everyone, for joining us this afternoon. We had a strong start to 2025 as we advanced our commercialization efforts for Zerzuve, the first and only oral treatment approved for adults with postpartum depression, or PPD. And we also are strategically progressing our refocus pipeline. Now, before I get into detail, I wanted to briefly address an important initiative. The SAGE Board of Directors continues to advance its strategic alternatives process. As we previously noted, SAGE is conducting a comprehensive process to evaluate a broad range of opportunities for the company to maximize value for shareholders. The review process remains ongoing. We've not set a timetable for the review process and do not intend to disclose further developments until we determine that disclosure is appropriate or necessary. Now, turning back to Zerzuve, we continue to be energized by the profound impact we're having on women with TPD and are driving our efforts forward to bring Zerzuve to more women suffering from this urgent medical condition. In the first quarter of 2025, Zerzuve was shipped to greater than 3,000 women with TPD. That represents a 22% increase from the fourth quarter of 2024. We generated $13.8 million in collaboration revenue for Zerzuva in the first quarter, which represents 50% of the net revenue recorded by Biogen, a 21% increase from the fourth quarter of 2024. Importantly, we are starting to see signs of a system-wide paradigm shift in the way healthcare providers, specifically OBGYNs, are increasingly screening, diagnosing, and treating PPD. We believe that enhanced screening, diagnosis, and treatment paired with a continued elevated national dialogue around maternal mental health, are critical to accelerating Zerzuve growth in PPD. In fact, as of today, I'm pleased to share that we've reached a significant milestone in advancing patient care. Since launch, we've shipped Zerzuve to greater than 10,000 women with PPD. We remain focused on our goal of establishing Zerzuve as a standard of care for women with PPD. And with our continued progress, we believe we're making advancements toward that goal. In addition to executing on our launch, we also continue to make progress on our pipeline. Last year, we recalibrated our R&D approach and we significantly reduced our cost structure, aligning our resources around the areas that we believe have the greatest potential for value creation. As a result of this work, we prioritized our clinical pipeline in neuropsychiatry and neurodevelopmental disorders. where we see strong scientific rationale and believe a significant unmet need exists. Specifically, we're excited about the potential opportunities for both SAGE 319 and our NMDA receptor NAM platform, which we believe could add significant value for shareholders and patients if our development efforts are successful. We also continue to evaluate next steps for SAGE 324. Mike will provide additional details on these programs. As we previously shared, Mike was appointed interim head of R&D and is leading the team forward. I'm confident in the continuity and execution of our clinical priorities under his leadership. With the commercial momentum of Zerzuva and PPD, our focused R&D approach, and cash runway expected to support operations to mid-2027, we believe we are well positioned toward our goal of creating value for our shareholders. I'll now turn the call over to Chris to discuss Zerzuve and our financial performance for the quarter. Chris?