Sage Therapeutics, Inc.

Please stand by, we're about to begin. Good morning. Welcome to Sage Therapeutics' fourth quarter and full year 2022 financial results conference call. Currently, all participants are in a listen-only mode. This call is being broadcast 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.

Good morning, and thank you for joining Sage Therapeutics' fourth quarter and full year 2022 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 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 fourth quarter and full year 2022. We will also be joined by Jim Doherty, our Chief Development Officer, who will review recent progress in development activities across our program. Our Chief Business Officer, Chris Bonecki, We'll provide an update on our launch preparations for Zorana Loan in MDD and PPD if approved, and we will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review the financial results from the fourth quarter and full year 2022. Laura Galt, our Chief Medical Officer, will be available for questions 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're advancing potential treatments for brain health by challenging conventions and prioritizing what matters most to patients. And today, our work matters more than ever. We've reached a public health crisis tipping point. Brain health disorders are one of the leading causes of disability and threaten to impact future generations. We see profound implications firsthand as friends, loved ones, and neighbors continue to struggle. Over the last half century, there have been insufficient advances in the treatment of mood, cognition, and other disorders of the brain. People deserve better, and we're determined to change the trajectory of this crisis. This is an incredibly exciting time at SAGE. We're progressing a promising and targeted brain health pipeline with the potential to impact millions of people globally. The pipeline is a result of our innovative approach to drug discovery and development, which starts with our novel work on the GABA and NMDA receptor systems. These pathways are important regulators of brain function and the key to unlocking potential breakthroughs that may improve brain health. Importantly, we believe our team and our strong financial foundation puts us in a position to further our pipeline ambitions. With the goal of being able to launch new drugs, or indications for years to come. The time is now to unleash the potential of our science in making meaningful impact on the lives of millions. Moving to the next slide, we're making progress across our pipeline as demonstrated by the latest regulatory milestone for Zoranolone, which we're developing in collaboration with Biogen. As we recently announced, we're encouraged by the FDA acceptance of our NDA filing for Zoranolone with priority review and major depressive disorder and postpartum depression with the BDUFA action date of August 5th of this year. If approved, we expect a potential launch near the end of 2023, assuming no extensions of the FDA review period. With that timing in mind, we remain laser focused on preparing for the potential commercialization of Zoranilone, which Chris will walk through in more detail. Our commitment to be as innovative in helping to enable access to treatments as we're developing our medicines, will be a key aspect of our overall commercialization strategy. To achieve that, we're collaborating across the ecosystem with payers, healthcare providers, patient advocates, and policymakers with a goal of providing a model for care that works in the best interest of patients with MDD and PPD. We look forward to providing updates as appropriate. I would like to note, since we now are in an FDA review period, we will not be making comments on the potential label, FDA interactions, or related topics. In addition to Xeran alone, we have a robust pipeline of investigational programs that have potential to help patients at all stages of their lifespan with nine clinical studies ongoing. These include SAGE 718, our first-in-class NMDA PAM, which we're currently advancing in four placebo-controlled studies and an extensive study across Huntington's, Parkinson's, and Alzheimer's disease. We're also making important progress and our neurology franchise led by SAGE 324, which is being evaluated as a potential treatment for people suffering from essential tremor and other neurological disorders. I'd also like to highlight some of our earlier stage programs, including SAGE 319 and SAGE 689. These are great examples of our product engine that we believe will continue to deliver robust product candidates and have the potential for long-term value creation. To close, I am confident 2023 will be a pivotal year for Sage, particularly as we look forward to the potential approval of Zoranilone and the advancement of our brain health pipeline. With that, I'll turn the call over to Jim for a more detailed discussion of our recent portfolio progress and current clinical expectations.