Sage Therapeutics, Inc.

Please stand by. Your conference is about to begin. Good morning. Welcome to Sage Therapeutics' third quarter 2023 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 this call is being recorded. I would now like to introduce Ashley Kaplowitz, Director of Investor Relations at Sage.

Good morning, and thank you for joining Sage Therapeutics third 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 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 third quarter of 2023. Our Chief Business Officer, Chris Bonecki, will provide an update on our preparations for the planned commercial availability and launch of Zerzube. We will also be joined by Laura Galt, our Chief Medical Officer, who will review recent progress across our pipeline, and by Kimi Yaguchi, our Chief Financial Officer, who will review the financial results from the third quarter of 2023. Mike Quirk, our Chief Scientific 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, Ashley, and thank you, everyone, for joining us this morning. We at SAGE have a purpose and the momentum that unites us all. The recent approval of Zerzuve as a treatment for adults with postpartum depression sparked a national dialogue with countless women sharing their stories online, building community, and expressing anticipation for a desperately needed new treatment option. These brave and inspiring women are North Star. And making a meaningful impact to women's health by focusing on the maternal mental health crisis brought about by PPD is our ambition. The approval of Zerzuve further validates our innovative approach to drug discovery and development. which starts with our work targeting the GABA and NMDA receptor systems in the brain. These pathways are key regulators of brain function and the main drivers of brain circuit activity. Research suggests that disruptions in these circuits are an underlying factor in many brain health disorders. Our deep understanding of these pathways, along with our robust neuroactive steroid platform, are vital to unlocking potential therapeutic breakthroughs for patients. We are not satisfied with the speed of innovation for brain health treatments. Brain health disorders are one of the leading causes of disability worldwide, yet the pace of innovation has not met the moment. To address this innovation gap, we're advancing our pipeline with the goal of elevating the standard of care to what truly matters most to patients. We're working to help people living with debilitating neurodegenerative disorders who have been seeking treatments to address cognitive impairment early in order to maintain their independence longer. And we strive to be the first company to deliver a new treatment for essential tremor in over 50 years. Patients are waiting, and I'm proud to lead SAGE forward. This starts with postpartum depression, or PPD. As the first and only oral treatment approved for adults with PPD, the Reserve has the potential to transform the treatment landscape as a new option in care. Women with PPD need new solutions to this devastating disorder that have the potential to act rapidly, and we are now one step closer to helping these patients and their families. Untreated PPD is a burden and can have lasting consequences for the mom and is often associated with negative outcomes for her baby and the entire family. Additionally, undertreated and untreated PPD has significant societal costs. We are pleased that the DEA completed its scheduling of Zirzuve as a Schedule IV drug, which is consistent with our expectations. We remain on track to make Zirzuve commercially available in December of this year. Now, Chris will provide specific updates related to this timeline. The heightened and persistent engagement we've seen from a diverse community of stakeholders since the FDA approval of Zirzuve in August, we believe will ultimately translate into strong tailwinds for the launch success of Zerzuve. While we recognize that referral patterns, insurance coverage, and current practices require change, we believe those women suffering from PPD deserve our full support efforts starting now. PPD is a serious medical condition and deserves attention. We plan to join others in prioritizing, normalizing, and destigmatizing this condition. While we remain focused on preparing for the launch of Zerzuve, We're also excited about entering what we believe will be a catalyst-rich 2024, with multiple data readouts expected across our SAGE 718 and SAGE 324 programs. Today, Laura will provide updates and more details on these programs. Looking ahead, we believe our future is bright. Following the reduction in our workforce and pipeline prioritization announced in late August of this year, we continue to operate from a strong financial foundation. Importantly, we remain well capitalized to accomplish our upcoming milestones. Kimi will provide more detail on our financial position later in the call. Now, many continue to ask about the status of development of Zoranolone and MDD. To be clear, our focus is on the successful launch of Zorzuve for women with PPD and working to enable broad and equitable access for these patients to this important new treatment option. On MDD, We plan to provide updates when SAGE and Biogen have made decisions on the program. For now, we're focused on commercializing Zirzuva for the treatment of adults with PPD. To close, I want to reiterate that this is an exciting time at SAGE with many upcoming milestones on the horizon. As we look ahead, I'm confident we're positioned to make important progress in pursuit of our mission. With that, I'll turn the call over to Chris to provide additional context on our upcoming commercialization plan for Zirzuve.