Sage Therapeutics, Inc.

Good morning. Welcome to Sage Therapeutics third quarter 2020 financial results conference call. Currently, all participants are in a listen-only mode. The call is being webcast live on the investor and media section of Sage's website at sagerx.com. This call is property of Sage Therapeutics and recordings, 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 Jeff Boyle, Head of Investor Relations at Sage.

Good morning, everyone, and thank you for joining Sage Therapeutics' third quarter 2020 financial results conference call. 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 the slides that contain supplemental details. 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 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 Mike Clunan, our Chief Operating Officer, Jim Doherty, our chief research officer, and Kim Iagucci, our chief financial officer. We will then be joined for the Q&A session of the call by Dr. Steve Keynes, our chief medical officer. Dr. Jeff Jonas, our chief executive officer, is recuperating at home from a surgical procedure and looks forward to connecting with many of you at upcoming investor conferences. And with that, I'll now turn the call over to Mike.

Thanks, Jeff, and thank you, everyone, for joining us this morning. We're pleased to update you on the progress across each of our development programs. But before I review results from the quarter, I want to let you know that Jeff is at home recuperating as expected from his scheduled surgical procedure and continues to make good progress in his recovery. We anticipate he will return full-time sometime in December and our thoughts are with Jeff as he continues his recovery. Today, I'll provide an overview of our third quarter activity and discuss progress across our depression, neuropsychiatry, and neurology franchises. I'll then turn the call over to Jim Doherty to provide an R&D and clinical update. And finally, Kim Iagucci will provide a review of our third quarter financials. Steve Canes will join us for the Q&A portion of the call. As we are now nearly nine months into the global COVID-19 pandemic, we've come to learn how the virus has impacted not only those infected, but all of us. particularly concerning is the effects the quarantine and pandemic have had on mental health. These past months have seen sharp increases in depression and risk factors for suicide. Now more than ever, our team is motivated to provide much needed options to patients suffering from debilitating brain health disorders. To that end, I'm pleased to report today that execution of our clinical programs remains on track. with a series of key milestones anticipated over the next 12 to 18 months. Our team of dedicated professionals has done a great job of driving this execution that we expect will set up a number of significant potential catalysts in the coming months. As you know, SAGE has a deep and robust clinical pipeline that spans across multiple disciplines with programs in early, mid, and late stage development. In September, we were pleased to host our annual FutureCast event, which gave a broad overview of each of our programs. Futurecast demonstrated that we follow the science with what we believe is a fundamentally different approach, one that aims to de-risk the drug development process. And we lean into the learnings from this process in a focused and creative way. In the nine years since our founding, we have generated very compelling data that support our methods. We believe the updates we provided at Futurecast, including clinical and patient perspectives, support our methodology. If you are unable to tune in, I encourage you to listen to the archive, which is available on our website in the investor relations section. Most recently, we announced positive interim data from our open label Shoreline study in major depressive disorder, or MDD, with Zoranilone. Jim will provide additional color about these data, but I want to take a minute to talk about what they mean to our depression program, patients, and for Sage as a company. We believe the Shoreline data supports the idea that depression is a medical condition that can be treated as needed. We look forward to the results of our ongoing and planned phase three programs, which we hope will provide further support. It would truly be a breakthrough if seranolone is successfully developed and approved for use as needed in treating MDD, representing a different approach to how depression can be thought about and treated going forward. And for patients, this approach would be potentially game changing. Our mission at Sage, as you've heard us say many times before, is to create and develop medicines that matter so people can get better sooner. We are working to bring new options to a spectrum of disease states where the unmet medical need is high. And in many cases, innovation is lacking and not just incremental changes. We have what we believe is one of the strongest pipelines in the brain health space with numerous novel chemical entities across multiple franchises. Our work to disrupt the treatment model in depression is only the beginning for Sage. We are excited as we plan for the continued progression of all three of our franchises, depression, neurology, and neuropsychiatry, over the near, mid, and long term. And now, I'll turn it over to Jim to walk you through the clinical updates. Jim?