ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals Second Quarter 2020 Financial Results Conference Call. My name is Jonathan, and I will be your coordinator for today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session toward the end of today's call. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed. Thank you.

Good afternoon and thank you for joining us on today's call to discuss Acadia's second quarter 2020 financial results. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q2 2020 financial performance and provide a review of our business. Also joining us today is Michael Yang, our Chief Commercial Officer, who will provide updates on our commercial initiatives, and Dr. Serge Sankovich, our President, who will discuss our pipeline progress. Our Chief Financial Officer, Elaine Ridloff, will then discuss our financial results in more detail before turning it back to Steve for final remarks and opening the call-up for your questions. I would also like to point out that we're using supplement slides, which are available on the events and presentation section of our website. Before we proceed, I would first like to remind you that during our call today, we will be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, or future results, are based on current information, assumptions, and expectations that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results that differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC. Your caution not to place undue reliance on these forward-looking statements, which are made only as of today's date. I'll now turn the call over to Steve.

Thank you, Mark. Good afternoon, everyone, and thank you for joining us today. Please turn to slide five. We've made important and significant progress on our three strategic pillars. As a reminder, this year we are focused on driving the growth of nucleoside for patients with Parkinson's disease psychosis, delivering on the dementia-related psychosis opportunity, our second indication for nucleoside, and developing innovative new treatments for unmet needs in CNS with three candidates in our early and late-stage development pipeline. At Acadia, our mission is to improve the lives of patients with CNS disorders by developing and commercializing new medicines. Our focus on these three strategic pillars enables us to execute on that promise. Let's turn to slide six to review. For the second quarter of 2020, New Plaza achieved $110.1 million in net sales, a 32% year-over-year increase driven by strong commercial execution. These strong results are reflective of the fact that we adapted quickly to the evolving environment resulting from the COVID-19 pandemic. Our commercial team is executing at a high level and successfully engaging both virtually and in person with healthcare practitioners. As a result of our team's successful execution, we've raised the lower end of our net sales guidance. We now expect full year net sales to be between $430 to $450 million, representing 30% growth year over year at the midpoint of the range. who are confident in driving the long-term market opportunity for nucleoside and PDP and look forward to the addition of DRP. Let's move to the DRP opportunity on slide seven. Our supplemental NDA for dementia-related psychosis was accepted for filing by the FDA with a PDUFA date of April 3rd, 2021. The filing of the application is an important next step as DRP is a devastating and highly disruptive disease and represents a significant unmet need not only for the patients but also for their caregivers and family members. We're highly confident in both the efficacy and safety data supporting our submission and look forward to continuing to work with the FDA to facilitate their review. Please turn to slide eight. We continue to make important progress in our late stage development pipeline. We've now initiated our second pivotal study, ADVANCE-2, into negative symptoms of schizophrenia. This phase three trial will enroll approximately 386 patients and evaluate them in a double bond fashion for 26 weeks with a 34 milligram dose of Pimivanserin. Our Rett Syndrome Lab Interphase III study recommenced patient enrollment in June. We anticipate top line results in the second half of next year. In addition, we are focused on business development to grow our development pipeline and leverage our internal R&D and commercial capabilities. For example, earlier this year, we licensed the M1 PAM program from Vanderbilt and we will continue to invest in our future through additional business development opportunities that complement our long-term growth strategy. With that, I will now turn it over to Michael to discuss our commercial performance and highlights.