Sage Therapeutics, Inc.

Good afternoon. Welcome to Sage Therapeutics second quarter 2024 financial results conference call. Currently, all participants are in 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 Ashley Kapowitz, Vice President of Investor Relations and Capital Markets at Sage.

Good afternoon, and thank you for joining Sage Therapeutics' second 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 second quarter of 2024. Our Chief Business Officer, Chris Bonecki, will provide an update on the ongoing commercialization of Zirzube in postpartum depression, or PPD. Laura Gault, our Chief Medical Officer, will review development activities across our programs. We will then be joined by Kimi Yaguchi, our Chief Financial Officer, who will review our financial results from the second 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 afternoon. As we progress through 2024, we remain focused on addressing unmet needs in brain health. Our successes and setbacks provide valuable learnings, and we push forward in our efforts to advance our science and support patients in need of new treatment options. As you may have seen, Last week, we in Biogen announced negative results from our Kinetic II study of SAGE324 in essential tremor, or ET. Given these results, we plan to close the ongoing open-label safety study and do not plan to conduct further clinical development of SAGE324 in ET. We recognize there's a high unmet need in this disease with limited innovation treatments over the past 50 years and are deeply disappointed with this outcome, and importantly, for ET patients. Now, we continue to work to accelerate launch momentum for Zerzuve and PPD and to progress our brain health pipeline and look forward to providing additional data readouts expected later this year. Now, where we are helping patients is postpartum depression. Turning to Zerzuve, I'm energized by the profound impact we're making on women with PPD and their families. We're the first and only oral medication approved for the treatment of PPD in adults. We're also seeing firsthand a progressive evolution in the treatment of PPD, particularly as OBGYNs are on the forefront of a movement to vastly improve screening, diagnosis, and treatment. It's encouraging to see the progress we've made as we near the one-year anniversary of the FDA approval of Zirzuva. The increasing demand and the growth in prescriptions and shipments in the second quarter is indicative of that progress, and supports our goal to establish Zuzuve as a first-line therapy and standard of care for women with TPD. I'll highlight a few of the encouraging signals we saw this quarter, which Chris will dive into in more detail. We observed strong quarter-over-quarter growth, Q1 to Q2, in prescriptions and shipments of Zuzuve. Shipments delivered to patients nearly doubled in the second quarter relative to the first quarter. reflecting the strong demand and level of interest we're seeing from HCPs for Zirzuve in treating women with PPD. HCP prescriber momentum continues with prescriptions in Q2 seen across the breadth of HCPs who treat PPD, and in particular, OBGYNs. Notably, early data suggests that OBGYNs who have prescribed Zirzuve are treating significantly more patients with PPD than they were previously. This is based on written prescriptions for all medications. This is an important metric that shows how Zirzuva is beginning to change the HCP treatment paradigm in postpartum depression. In addition, the number of new and repeat Zirzuva prescribers grew during the second quarter of 2024, and we're seeing many OBGYNs write Zirzuva for multiple patients. We continue to have strong commercial and government access for Zirzuva and PPD, and with the majority of plans to date not imposing onerous prior auths or step edits for postpartum depression. We are also seeing momentum across the ecosystem with broad policymaker interests across the country to advance policies to improve maternal mental health outcomes. For example, the state of Louisiana recently signed into law a bill that generally permits women with TPD to to bypass step therapy requirements by commercial insurers and gain direct access to FDA-approved treatments for PPD. We believe this law will help enable women with PPD in the state to gain direct access to Zirzuva when prescribed. As we highlight at launch, our strategy has been to launch with a focused approach and scale as we see success. As the signs of launch have been encouraging, in addition to expanding marketing and non-personal promotion, staged plans to strategically expand its sales force in early Q4, where we believe additional resources will help accelerate demand for Zerzuve in the treatment of PPD. We believe this planned expansion of our sales force is well-timed with access coverage and improvements in the specialty pharmacy processes. It will help to support the growing focus to treat PPD and to accelerate commercial momentum. 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. And we look forward to sharing more updates on our launch progress in the coming quarters. Moving to our clinical stage pipeline, we recently announced data from our Phase II Kinetic Tube study in essential tremor, as I highlighted previously. We also continue to progress our clinical development program for Dowson-Emdor, our wholly-owned NMDA receptor-positive allosteric modulator, or PAM, formerly known as CH718. In June, we reported results from our Phase II Surveyor Study of Dalsodamdor, which reinforces the cognitive impact of Huntington's disease, or HD, and historically under-recognized aspects of HD, for which there are no approved treatments. As you may have seen in our press release this afternoon, based on our review of relevant data, we have decided to adjust the primary endpoint in our ongoing placebo-controlled dementia study in HD from the HD-CAB composite to the symbol-digit modalities test, or STMT, one of the cognitive tests included in the composite. Laura will provide additional context and information for this change. Both the Phase II light wave and dementia studies remain on track to read out late 2024. Additionally, we remain encouraged about the potential of our earlier stage pipeline, including stage 319 and stage 421, and believe the important development opportunities as we explore areas of unmet need in brain health. With that, I'll turn the call over to Chris to provide additional context on the ongoing commercialization of Zirzuve in postpartum depression. Chris?