Sage Therapeutics, Inc.

Good morning and welcome to Sage Therapeutics first quarter 2024 financial results conference call. Currently, all participants are in a listen-only mode. This call is being webcast live on the Investors and Media Selection 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 Ashley Kaplowitz, Vice President of Investor Relations and Capital Markets at Sage.

Good morning, and thank you for joining Sage Therapeutics' first quarter 2024 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 and slides related to today's call. 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 marks by Barry Green, our Chief Executive Officer, who will provide an overview of our progress during the first quarter of 2024. Our Chief Business Officer, Chris Bonecki, will provide an update on the ongoing commercialization of Zerzube. We will also be joined by Laura Gault, our Chief Medical Officer, who will review development activities across our programs. We will then be joined by Kimi Noguchi, our Chief Financial Officer, who will review our financial results from the first quarter of 2024. 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. As we progress through 2024, we are singularly focused on addressing unmet needs in brain health. And while the science is extremely challenging, we remain motivated toward a common goal, improving human health. As you may have seen, last week we announced negative results from our precedent study in the DALS and MDAR program in participants with mild cognitive impairment related to Parkinson's disease. We're deeply disappointed for patients and their families. As we know, mild cognitive impairment in Parkinson's disease can have a devastating impact on an individual's life. We continue to believe that these results are not necessarily predictive of the results in our ongoing studies. It's important to remember that all cognitive impairment is common across Huntington's disease and Alzheimer's disease. The underlying pathophysiology and symptomatology of these diseases are very distinct. We look forward to data across the Dalsan-Emder program expected throughout 2024, as well as top-line data from our Kinetic II study in essential tremor expected mid-2024. I'd now like to focus on a very encouraging area of opportunity for SAGE and for women with PPD. As you'll soon hear from Chris, the launch of Zuzube is off to a strong start, as is reflected by our first full quarter performance. I'm inspired by the positive anecdotes and success stories we're starting to hear from women with PPD who have been treated since launch. The impact of Zuzube on these moms and their families is profound, and it's energizing all of us. we continue to believe Zirzuve is the key to unlocking the blockbuster potential of PPD, enabling us to help many women suffering from this devastating disease. While early, we're beginning to see signs of practice patterns changing, particularly among OBGYNs. With approved oral treatment specifically for PPD, we believe healthcare prescribers have started to shift from suspect and refer to screen, diagnose, and treat. I'll highlight a few of the encouraging signals we're seeing in the first quarter of launch. Demand in PPD has been strong and continues to grow. Interest among healthcare prescribers with whom we've engaged or who have learned about Zirzuve has been high, evidenced by Zirzuve being prescribed for women with PPD across a wide range of healthcare prescribers. We're also highly encouraged by the progress we've made with commercial and government payers. Payers are beginning to develop policies, and for the majority of plans to date, we're not seeing onerous prior-offs or step-adds to PPD. Our teams in the field remain busy engaging with critical stakeholders, educating prescribers, and contributing to the recognition of PPD as an urgent medical condition. We believe the PPD opportunity is significant and have thought broadly about the initiatives needed to achieve commercialization success with Zerzuve. Our strategy is to launch with a focused approach and scale as we see success. As the early signs of launch have been encouraging, we've been increasing our marketing and non-personal promotion resources. If the positive trends continue, we believe additional scaling this year makes sense. Our goals are clear. Establish Zerzuve as the first-line therapy and standard of care for women with PPD and advance our brain health pipeline. Our work is more important than ever, and the countless lives we have potential to positively impact continues to serve as our North Star. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zerzuve. Chris? Thanks, Barry.