Sage Therapeutics, Inc.

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

Good morning, and thank you for joining Sage Therapeutics' fourth quarter and full year 2020 financial results conference call. Before I 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'd like to point out that we'll 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. With me on the call today are Barry Green, our Chief Executive Officer, who will set some context and provide some opening remarks. Steve Canes, our Chief Medical Officer, who will review our clinical progress to date. And Kim Iagucci, our Chief Financial Officer, who will provide a financial overview. We will then be joined in the Q&A by Mike Clunan, our Chief Operating Officer. And with that, I'll turn the call over to Barry. Thanks, Jeff. And thank you, everyone, for joining us this morning. The end of 2020 and the beginning of 2021 have been terrific for Sage, and we're pleased to update you on the progress we're making in our efforts to build the leading brain health company, positioning Sage to become a top-tier biopharmaceutical company. With the pandemic raging, the U.S. engaged in destructive political discourse and events highlighting once again the work to be done to eliminate racism and racial injustice. 2020 was a particularly challenging year for all of us. And on top of that, SAGE had additional significant challenges to work through. I'm proud to see, however, that the SAGE team demonstrated grit and determination with a commitment to science, innovation, and execution throughout 2020 and into 2021. And despite these headwinds, 2020 was a year marked by progress across our entire pipeline. Today, we have three programs in late-stage development with five ongoing Phase III trials due to readout this year. Additionally, we have five mid- and early-stage programs in clinical development, and we're committed to a goal of developing two or more high-quality IND-enabling investigational products per year by 2023. SAGE is tackling big problems of global health in areas where there has been little innovation over the past few decades. In just under a decade since the company was founded, we've made deep scientific progress in understanding brain circuitry by focusing on the GABA-A and NMDA pathways, and applying unique chemical innovation in the areas of neuroactive steroids, including oxysterol chemistries. The team has created innovative potential therapeutics focused on allosteric modulation, building from knowledge of endogenous starting points to target receptors that dial in specific properties to engage these pathways with highly tailored approaches. As you all know, I joined SAGE's CO in December. I believe Sage's mission, making medicines that matter so people can get better and stay better, is achievable through the innovative ways Sage discovers and develops medicines. Importantly, our approach to date has worked. Sage developed the first-ever treatment specifically approved for women with postpartum depression and has a rich pipeline of potential treatments focused on brain health that, if successfully developed, will give patients the opportunity to get their lives back. We have an extraordinary opportunity to transform the lives of millions of people with brain health disorders. SAGE is at the forefront of developing therapeutics targeting brain health disorders. I believe this is the next frontier of innovation. What I saw and continue to see in SAGE is scientific rigor with a proven track record of successfully converting robust chemical capability into a rich pipeline of novel clinical programs. a deep pipeline with multiple franchises, strong collaboration partners, the resources needed to become the leader in brain health, and mission-driven employees who are determined to make a difference in the lives of patients. And that cannot be underestimated. But what I was particularly struck by, and what I consider to be one of our core strengths, is that we are one of the few brain health companies that drives drug development every step of the way. from SAGE-created development programs through research into clinical development and approval. I'd like to walk through some of the highlights of 2020. In November, we announced a transformational global collaboration with Biogen for Xeranilone and SAGE-324. We believe Biogen is the right partner, and this collaboration gives us the opportunity to reimagine depression and essential tremor while also potentially expanding and accelerating development of innovative brain health treatments on a global scale. we now have the potential to reach over 450 million people around the world with our innovative product candidates if we're successful. And with an experienced partner for Zaranolone and Sage 324 and more than $2 billion of capital, we're in a stronger position than ever to accelerate not only the development of our late-stage GABA programs, but also our promising NMDA platform and the development of our novel discovery programs, advancing our mission of making medicines that matter. In October 2020, we announced positive interim data from the open-label Phase III Shoreline Study 30-milligram dose. This first-of-a-kind, naturalistic, longitudinal clinical development trial conducted as part of our program in major depressive disorder is designed to naturalistically follow patients with MDD and evaluate the safety and tolerability of both the 30- and 50-milligram doses of ziranolone in adults for up to one year. Importantly, The interim data showed that more than 70% of patients who responded to an initial course of treatment with 30 milligrams of ziranolone needed just two or fewer two-week treatments in a one-year follow-up period. That's a total of two to four weeks of treatment, or better yet, 48 weeks without ziranolone treatment. For patients, this alternative approach to treatment could mean they are no longer defined every day by their depression. Additionally, Zoranilone was well-polarized in the study with a safety profile consistent with results to date. We believe these data reinforce the potential of Zoranilone to become an as-needed treatment option for patients with MDD. Steve will provide additional learnings from Shoreline later in the call. I will say these data are very consistent with what we've seen with Zoranilone in clinical trials to date with more than 3,000 subjects or patients' dose. We've seen a rapid onset of activity durable effect over the study period, clinically meaningful improvements in depressive symptoms, and Zoranolin has been generally well-tolerated. If Zoranolin continues to perform as well as these data demonstrate, and we succeed in obtaining the necessary regulatory approvals, it will be a significant advance in how depression is treated. And SAGE, along with our collaboration partners, will be well-positioned to help patients across the globe deal with the brain health pandemic that hundreds of millions of people are today facing. I'm incredibly impressed by the SAGE team and what they've accomplished over the last year. We initiated six new clinical trials across our portfolio in 2020 and demonstrated our ability to adapt and work flexibly across our organization. 2021 promises to be a catalyst-rich year with 10 readouts expected across our multi-franchise brain health portfolio. If successful, we believe we have ability to pursue treatments for diseases that affect hundreds of millions of people worldwide. With that, I will turn the call over to Steve to discuss the progress in our clinical development programs.

Steve?