Sage Therapeutics, Inc.

Good morning. Welcome to Sage Therapeutics' fourth quarter and full year 2023 Financial Results 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 that this call is being recorded. I would now like to introduce Ashley Kaplowitz, Executive Director of Investor Relations and Capital Markets at Sage.

Good morning, and thank you for joining Sage Therapeutics' fourth quarter and full year 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 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 remarks by Barry Green, our Chief Executive Officer who will provide an overview of our progress during the fourth quarter and full year 2023. Our Chief Business Officer, Chris Bonecki, will provide an update on the ongoing commercialization of Zerzube. We will also be joined by Laura Goltz, our Chief Medical Officer, who will review recent progress in development activities across our program. We will then be joined by Kimia Gucci, our Chief Financial Officer, who will review the financial results from the fourth quarter and full year 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. 2023 was a pivotal year for SIGS, highlighted by the approval and commercial availability of our second FDA-approved product, Zirzuve, the first and only oral treatment approved specifically for adults with postpartum depression, or PPD. We have a big year ahead of us and even greater potential to build a leadership position in brain health and a top-tier biopharmaceutical company. Our reach and expertise across various brain health conditions are key to our work to unlock potential breakthroughs to help patients suffering from a wide range of brain health diseases. Brain health diseases are one of the leading causes of disability worldwide, yet novel treatment options in care remain limited. We are seeking to change that with a pipeline designed to address brain health disorders and improve public health. Brain health is fundamental to well-being and function at each stage of life. For pioneering science, we aim to advance programs that have the potential to improve the lives of individuals living with brain health disorders and their families. We're focused on modulating brain network function and disruptive circuits, an underlying factor in many brain health disorders. Starting with compounds that selectively modulate GABA and NMDA receptor activity, our expertise in neuroactive steroids includes oxyscalal chemistry, allowing us to choose compounds for development based on a number of factors, including the potential to modulate these circuits. Nerzube is an important example of how we leverage our deep expertise in understanding these receptor systems to discover a novel therapy. Nerzube was made commercially available in mid-December 2023. giving us about 10 days in 2023 where women with PPD in need of treatment could access health care providers. We're excited that we're getting this new treatment option to women who desperately need it. Of course, our work has continued in 2024, and I'm inspired by the stories from our teams in the field in just the first few weeks of launch. Women with PPD and their families now have a treatment option with the potential to make a profound difference in their lives. And the providers with whom we've spoken see Zerzuve as a potential catalyst to increase much-needed screening, diagnosis, and treatment of PPD across the healthcare system. It's early, but I do believe that Zerzuve is the key to unlock the blockbuster potential of PPD, enabling us to help many women suffering from postpartum depression. Importantly, there have been encouraging developments across the treatment landscape. We're starting to see PPD recognized as an urgent medical condition. There's more conversation and dialogue about addressing stigma, and the treatment system is mobilized to better support patients. I want to thank advocates and providers who have prioritized addressing maternal mental health treatment disparities. Turning to the launch progress, Zerzuve has generated $824,000 in collaboration revenue during the fourth quarter of 2023. As a reminder, our reported collaboration revenue is 50% of the net sales by agent records for Zerzuve. As we are very early in launch stages, we're not discussing specific revenue expectations or launch trajectory. However, what I can say today is that we're encouraged by the initial progress we're seeing. Our early initiatives aimed at establishing Zerzuve as the first-line therapy for women with PPD have begun to translate into strong tailwinds for the launch of Zerzuve. Just a few critical highlights. We're hearing that women with PPD are starting to step forward to advocate for Zuzuvay as they discuss treatment options with their healthcare providers. Healthcare providers, including psychiatrists, OB-GYN, primary care, nurse practitioners, and physician assistants are writing prescriptions for Zuzuvay in the treatment of PPD. A specialty distribution network is in place designed to provide a positive experience for patients with convenient home delivery. The Zerzuve4U Patient Assistance Program is helping to support timely access for eligible patients. Of course, as I said, we're early in launch days, and there are aspects of launch we certainly need to optimize, but the initial response and uptake are highly encouraging. Chris and Kimmy will provide additional updates later in the call, and we look forward to sharing more detail on our progress in the coming quarters. While the launch remains our top priority, We're also excited by all that we have ahead of us in 2024, with multiple data readouts expected across our ongoing studies in Dowson-Emdor, also known as Sage 718, as well as Sage 324. We believe in the potential of both molecules to help patients in need and to become significant drivers of long-term value creation as we aim to strengthen our leadership position in brain health. Additionally, we're excited about the continued progress on our early-stage pipeline with Sage 319 and Sage 421. We remain confident in our ability to continue to execute across our pipeline as we head into a catalyst-rich 2024. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zerzuve. Chris?