Sage Therapeutics, Inc.

Good afternoon. Welcome to Sage Therapeutics third 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 section of Sage's website at sagerx.com. This call is a 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 Katie Plant, Manager of Investor Relations at Sage.

Good afternoon, and thank you for joining Sage Therapeutics' third 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 remarks by Barry Green, our Chief Executive Officer, who will provide an overview of our progress during the third quarter of 2024. Our Chief Business Officer, Chris Benecke, will provide an update on the ongoing commercialization of Zervive. We will then be joined by Laura Galt, our Chief Medical Officer, who will review development activities across our program. We will then be joined by Kimi Iguchi, our Chief Financial Officer, who will review our financial results from the third 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 will now turn the call over to Barry.

Thanks, Katie, and thank you, everyone, for joining us this afternoon. Discovering new medicines and bringing them to market, especially in brain health, is a formidable challenge, but when successful, has potential for major advances in human health. The impact of our work in postpartum depression is an important example of this. However, other areas of drug development, including the most devastating brain health conditions, remain the next frontier. Recent pipeline setbacks require us to further focus our business priorities. We announced earlier this month that we are implementing a reorganization of our business operations intended to strengthen our balance sheet and focus investment to support the ongoing launch of Zerzuve for the treatment of women with PPD, our upcoming readout in Huntington's disease, and exploring opportunities across our early stage pipeline. This decision was necessary. We believe that this restructuring will right-side sage for future success. I'm grateful to all our employees, including those departing, for their impact on our business and dedication to making a difference for patients. As you've seen in our recent press release, we're also making the strategic decision to stop making Xilresso commercially available after December 31st, 2024. As we've noted, we've made progress in supporting more women with PPD since the launch of Zirzuve, and we see this important treatment accelerating change in the PPD treatment paradigm. With the increased demand for Zirzuve in the treatment of women with PPD, we're also seeing an expected decrease in demand for Zilrezo. We believe healthcare providers who have prescribed Zilrezo will continue to transition to Zirzuve and that women with PPD will be well supported by Zirzuve. It's a logical business decision to discontinue availability and focus our resources on Zirzube so we can help even more women with PPD. Now, as we are focused on PPD, Sage and Biogen will also not pursue further development of Ziranolone as a treatment for major depressive disorder in the U.S. Based on the significant new investment and time we expect would be needed to conduct the additional studies, and we're prioritizing our resources on supporting the PPD patient community. We're grateful to all the patients, providers, and advocates who have supported our clinical trials and efforts in MDD. We believe these decisions will provide us with the agility, cash runway, and focus to advance our business. We continue to build a foundation for the future that is supported by the momentum we're seeing with Zerzuve. Last year, we set a goal to establish Zerzuve as a first-line therapy and standard of care for women with PPD. We're making progress as demonstrated in our third consecutive quarter of solid growth. Zuzube has a critical role in advancing PPD care by helping to support a dialogue between healthcare providers and women with PPD, a condition that has often been stigmatized and undertreated. As a result, more women have the potential to be treated for PPD and more OBGYNs should begin to screen, diagnose, and treat this disorder. We believe the shift in practice patterns is starting among OBGYNs who are now integrating maternal mental health with obstetric care and initiating medical treatment for PPD. In fact, once an OBGYN has written his resume, on average, we see an encouraging increase in the number of women with PPD they treat based on written prescriptions for all medications. Of those healthcare prescribers prescribing Zirzuve, the majority are using Zirzuve as a first-line PPD treatment. We're seeing broad and favorable coverage for Zirzuve and PPD, and progress across the ecosystem continues to energize our efforts. Since launch, women with PPD are going online and sharing their treatment success stories. Medical associations are publishing screening guidelines. Payers are recognizing the benefit of innovation. and the media continue to discuss PPD as an urgent and treatable medical condition. While progress in overall screening rates for PPD is encouraging, it should be the first step in a deliverable process to ensure women who are diagnosed with PPD understand their options for care. Chris will provide more specific breakdowns of our commercial performance in Q3. Looking ahead, we plan to continue to scale with success and believe that our strategic investments including our recent salesforce expansion, will accelerate the demand and market growth for Zuzuvay and PPG. Now, turning to the pipeline, earlier this month, we reported that the Phase II Lightwave Study in Alzheimer's disease did not meet the primary endpoint. We're disappointed for the millions of patients suffering with Alzheimer's disease. We look forward to reporting top-line data from the Phase II Dementia Study of Dowson-Amdor for people with cognitive impairment associated with Huntington's disease expected later this year. Finally, we announced in September that Biogen has decided to terminate our collaboration and license agreement for the Sage 324 program. With the termination of this agreement, Sage will have full ownership of Sage 324, and we plan to continue to evaluate potential indications, if any, for the program. We anticipate that any future investment in Sage 324 will be based on a broader portfolio review and pipeline prioritization. Our commitment to advance brain health medicines endures through our successes and setbacks. Patient impact, long-term growth, and value creation remain our guiding principles. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zerzuve.