Sage Therapeutics, Inc.

And by we're about to begin. Good morning. Welcome to Sage Therapeutics first quarter 2023 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 and 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.

Good morning, and thank you for joining Sage Therapeutics' first quarter 2023 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 related to today's call, as well as the 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 SAC 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 of 2023. We will also be joined by Jim Daugherty, our Chief Development Officer, who will review recent progress in development activities across our programs. Our Chief Business Officer, Chris Benecke, will provide an update on our preparations for the potential launch of the rent alone in MDD and PPD. And we will then be joined by Kimmy Eguchi, our Chief Financial Officer, who will review the financial results from the first quarter of 2023. Laura Galt, our Chief Medical Officer, will be available during the Q&A portion of the call. With that, I'll now turn the call over to Barry.

Thanks, Helen. And thank you, everyone, for joining us this morning. At SAGE, We are driven by our mission to develop brain health medicines that deliver what matters most to patients, so every person can thrive. We do this by acting with urgency and challenging scientific convention to think differently as we work to develop new and effective treatments. This month marks Mental Health Awareness Month, which is an important reminder that the need for innovative brain health medicines has never been greater. Depression is the leading cause of disability for young people and those in their prime working years. And the problem, as we all know, continues to grow. Alarming research published recently by the World Health Organization shows that rates of suicide have increased in the U.S. by more than 40%. Simply put, Mental Health Awareness Month reminds us all that we must do more to challenge these trends. People with depression deserve better. Time is now. for SAGE to lead the way in making a difference for patients. 2023 will be a pivotal year for SAGE and is already off to a strong start. We are laser-focused on preparing for the potential launch of seranolone and believe we're on our way to achieving our vision of transforming the treatment of depression if seranolone is approved. We're also advancing our robust brain health pipeline comprised of several new chemical entity development candidates, that is a result of our product engine. We believe our pipeline holds the potential to help millions of people suffering from brain health disorders and deliver significant long-term value creation. Importantly, our work is backed by a strong financial foundation that we believe puts us in a position to further our pipeline ambitions with the goal of being able to launch new drugs or new indications for years to come. Looking forward, we have many key milestones on the horizon. First, the NDA filing for Zoranilone in MBD and PPD is under review by the FDA with a PDUFA action date of August 5th. Now, as I mentioned during our last earnings call, during this review period, we'll not be making detailed comments on the potential label, FDA interactions, or other related topics for Zoranilone. As we prepare for the potential launch of Zoranilone, We in Biogen are continuing permitted prelaunch commercialization activities. We're actively engaged in discussions with payers and policymakers and collecting key insights from healthcare providers and patient advocates with a goal of providing a model of care that works in the best interest of patients with MDD and PPD. Additionally, our team and collaborators have presented data at several key meetings highlighting the negative impact of depression on patients, their families, and society. These findings provide an important backdrop to our ongoing launch preparation. Chris will provide additional details on our ongoing and planned commercialization activities later in the call. We in Biogen are also advancing SAGE 324, which we believe holds potential to provide differentiated benefits to patients with essential tremor and other movement disorders. Now, turning to neuropsych, we're making progress across our wholly-owned SAGE 718 and MDA PAM programs. With Sage 718, we're leading with Huntington's disease, a devastating condition where deficits in executive function manifest during prime working years. We're also continuing to execute phase two studies with Sage 718 and cognitive impairment due to Parkinson's and Alzheimer's diseases. To close, I'm very pleased with our achievements so far this year and look forward to continued progress in 2023. The time is now to unleash the potential for our science and making meaningful impact on the lives of millions. With that, I'll turn the call over to Jim for a more detailed discussion of our recent portfolio progress and current clinical expectations.