Sage Therapeutics, Inc.

Good morning and welcome to Sage Therapeutics Business Update. Currently, all participants are in a listen-only mode. This call is being webcast 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 express written consent of Sage Therapeutics is strictly prohibited. Please note that this call is being recorded. I would now like to introduce Ashley Kaplewicz. Please go ahead.

Good morning, and thank you for joining SAGE Therapeutics' conference call to discuss business updates, including the FDA approval of Zoranilone, now branded in the United States as Zirzuve, as a treatment for adults with postpartum depression or PPD. Before we begin, I encourage everyone to go to the investor and media section of our website at sagerx.com, where you can find the press release related to today's call as well as slides that we will be reviewing today. 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. Then, Laura Galt, our Chief Medical Officer, will review the label for Zerzuve and supporting clinical data. Our Chief Business Officer, Chris Bonecki, will highlight our commercial preparations and launch plans for Zerzuve and PPD. And Kimi Noguchi, our Chief Financial Officer, will close with a financial update. Jim Doherty, our Chief Development Officer, will also be available during the Q&A portion of the call. With that, I'll now turn the call over to Barry.

Thanks, Ashley. And thank you, everyone, for joining us today. This is a historic moment for all women suffering from PPD. On Friday, we and our collaboration partner, Biogen, received approval from the FDA for Zoranolone, now known as Zirzuve, for the treatment of adults with PPD. Zirzuve is the first and only oral treatment specifically indicated for PPD. Hundreds of thousands of women have been waiting and hoping for this moment. We hear so many devastating stories about the impact of PPD, and many of us have been personally touched by this often neglected condition that's estimated to affect approximately 500,000 women each year. Today, there is a new source of hope. Before we begin, I'd like to take a moment to sincerely thank the dedicated healthcare providers, patients, caregivers, and advocates who have made today possible, especially the patients who have placed their immense trust in us throughout our clinical trials. We are and will always be an inspiration for us. We applaud your dedication to seeking new treatment options for PPD. I'd also like to comment on the status of our NDA seeking approval for Zoranilone in the treatment of major depressive disorder, or MDD. As many of you have seen, late on Friday, we received a complete response letter from the FDA for Zoranilone as a treatment for adults with MDD. We are devastated for patients and deeply disappointed with the FDA's position in issuing the CRO. We are reviewing feedback from the FDA and evaluating next steps. As we have clarity, we'll share more. Many have questions that we can't answer and others that we just simply can't at this time. Now, just to be clear, progress in treating depression is not keeping pace with the accelerated prevalence and burden of this debilitating disease. Despite current treatment options, people with depression continue to struggle. A change in the treatment paradigm and approval of novel options is desperately needed. Later in the call, Kimi will provide an update on the financial implications given this development. For those of us that have been in the pharmaceutical industry for decades, going through adversity is an opportunity to come out more lean and agile on the other side. We will work through this. What I can say for now, per se, is that we'll be making smart, disciplined decisions intended to maintain a robust balance sheet. This is an opportunity to merge as a stronger company with a refined strategy and a focused approach. Now, turning back to our primary focus for today's call, following Friday's approval, we have the first and only oral treatment specifically indicated for women with PPD. As a 14-day short-course treatment, we believe that Zirzuve will provide women with PPD a desperately needed new treatment option. with the potential to treat their depressive symptoms quickly without the need for chronic treatment. Given the limited treatment options available for women with TBD, we're excited about the opportunity to bring their Zouvet to those patients. We expect their Zouvet to launch and be commercially available in the fourth quarter of 2023, shortly following the completion of scheduling as a controlled substance by the USDA, which is expected to occur within 90 days of this approval. The widespread national media attention on the approval of Zerzuwe for the treatment of women with PPD reinforces that this is truly a critical milestone given the significant unmet need that currently exists for the treatment of women with this disease. PPD is a serious medical condition. We know that women with PPD often face extreme challenges in their daily lives and with infant bonding, often feeling overwhelmed, anxious, and isolated. If left untreated, Depressive symptoms can persist beyond a year postpartum, which can be associated with prolonged maternal morbidity and mortality. While a woman's PPD can be associated with short-term consequences in newborns, it can also result in long-term developmental, psychological, cognitive, and physical ramifications for her children. The devastating generational impact of PPD has been often overlooked. With the approval of Zerzuve, We now have the first and only oral treatment indicated for women with PPD, and we stand ready to help. I want to take a moment to recognize the entire SAGE and Biogen teams and our collaborators who have brought us to this important day for women with PPD. None of what we do is possible without your hard work, dedication, and faltering belief that together we have the potential to change the mental health landscape. I thank every one of you for your contributions towards our mission. With that, I'll now turn the call over to Laura.