Sage Therapeutics, Inc.

Good morning. Welcome to the Sage Therapeutics third quarter 2022 financial results conference call. 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 Helen Rubenstein, Director of Investor Relations at Sage. Please go ahead.

Good morning, and thank you for joining Sage Therapeutics' third quarter 2022 financial results conference call. Before we begin, I encourage everyone to go to the Investors and Media section of our website at sagex.com. where you can find the press release related to today's call, as well as the slides that contain supplemental details. I'd 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 consult 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 third quarter. We will also be joined by Chris Benecke, our Chief Business Officer, who will provide an update on our progress in preparation for the potential launch of the Rana Loan in MDV and PPD. Jim Dougherty, our Chief Development Officer, will review recent progress in development activities across our program. And Kimi Iguchi, our Chief Financial Officer, will review the financial results from the quarter. With that, I'll now turn the call over to Barry.

Thanks, Alan. And thank you, everyone, for joining us this morning. 2022 has been a year of focused execution at stage, and we're extremely pleased with all the progress we've made across our three brain health franchises. Our vision is clear. We want to fearlessly lead the way to create a world with better brain health. I believe we're well on our way to accelerating our leadership in brain health and reaching our goal to become a top tier pharmaceutical company. As we reflect on our accomplishments, including reported positive data from multiple clinical studies and initiating trials across our pipeline, we remain confident in our ability to execute for the remainder of this year, and we believe that we have the team to successfully advance our programs across brain health disorders for years to come. All of us at Sage are driven by a tremendous sense of urgency to create novel medicines for people who currently lack adequate treatment options and we're focused on addressing what matters most to patients. To that end, we've made great progress in building our organization this year to support the exciting milestones we have ahead. With that, I'll review our recent progress, starting with our depression franchise, led by Zoran Alun. The national dialogue is finally shifting to focus on a better approach to support the millions of people who are living with depression. We know that depression is complex and that failing to address it can negatively impact people's ability to maintain relationships, be productive at work, and engage in activities they enjoy. As we said for years, and a recently published just last month in the Journal of Clinical Psychiatry further supports, depression is associated with an increased incidence of dementia, Alzheimer's, cardiovascular disease, metabolic syndrome, diabetes, obesity, and certain autoimmune diseases. It doesn't have to be this way. we have a clear opportunity to help people living with depression and are encouraged by our progress. To that end, we continue to move forward on the rolling NDA submission of Zoranilone for major depressive disorder or MDD and postpartum depression or PPD, which is on track to be completed in December of this year. If the FDA grants priority review of our NDA, our PDUFA date would likely be in the third quarter of 2023. If we achieve those milestones, and Zoranilone is approved for the treatment of MGD and PPD without extension of the FDA review period, we expect a potential launch near the end of 2023, following an anticipated three-month DEA schedule review. We will be ready. Based on the totality of data generated across the Zoranilone development program, we believe that Zoranilone has the potential to be a differentiated treatment option for people suffering from MGD and PPD. As we prepare for a potential launch, We and our collaborators at Biogen are thinking big while taking a staged, data-driven approach and are prepared to scale fast with success. We know that to launch successfully, we'll need to continue to deepen our engagement with key stakeholders, including healthcare providers, patients, patient advocacy groups, policymakers, and payers. Over the past year, we've presented key analysis on Xeranalone at several important medical congresses. The analysis highlights the data on rapid and durable effect and a generally well-tellied safety pro seen in clinical studies in MDD and PPD, but used either as monotherapy or adjunctotherapy. Chris will share more detail on the positive reactions we've received from the scientific community, as well as feedback from our key stakeholders that continue to be vital as we advance our commercial Lewis plans towards our analysts. Now I'll turn to our neuropsych franchise led by Sage 718, a wholly owned, first-in-class NMDA PAM. We're excited to continue progressing a robust clinical program with multiple ongoing and planned Phase II studies in Huntington's disease, Parkinson's disease, and Alzheimer's disease. Today we are excited to share the design of our planned Phase II study in Alzheimer's disease, which Jim will walk through later in the call. Impaired cognition is a significant morbidity in the indications we're studying with SAGE-718 and can negatively impact people's ability to live life independently. We're committed to advancing the SAGE-718 program with the goal of further demonstrating its therapeutic potential and novel approach. I'd also like to highlight key corporate updates included in this morning's press release. First, I'm delighted to welcome Dr. Laura Galt to SAGE as Chief Medical Officer. In her new role, Laura will be a strategic member of the SAGE leadership team focused on advancing SAGE's current and emerging product pipeline through all stages of development. Laura brings more than 15 years of experience as your strategic global cross-functional leader with an established track record of neuroscience-directed development and designing innovative clinical trials from first-in-human through post-marketing trials. Laura complements a very experienced leadership team that is well prepared to lead Sage for years to come. Additionally, Jeff Jonas will be transitioning from his role as our Chief Innovation Officer as he embarks on a new journey at a global private equity firm. While Jeff will no longer hold a full-time role at Sage, we're pleased to have him continue as a member of our Board of Directors and other committees. Jeff has made significant contributions to Sage over the past decade, joining the company first as CEO, and then playing a critical role in our drug development strategies as Chief Innovation Officer. We extend our sincere thanks for his leadership in growing the company and helping advance our mission of creating a world with better brain health. We wish him great success in his future endeavors. I'd now like to invite Jeff to say a few words. Jeff?