ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to Acadia Pharmaceuticals' third quarter 2020 financial results conference call. My name is Gigi, 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 towards the end of today's call. If at any time during the call you require assistance, please press star followed by zero, and a coordinator will be happy to assist you. 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 third 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 Q3 2020 financial performance and a review of our business. Also joining us on today's call is Michael Yang. our Chief Commercial Officer, who will provide updates on our commercial initiatives, and Dr. Serge Sankovic, our President, who will discuss our pipeline progress. Our Chief Financial Officer, Elena 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 Presentations section of our website. Before we proceed, I would first like to remind you that during our call today, 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 to differ materially. These factors and other risks that are 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. First, we are driving the growth of New Plaza for patients with Parkinson's disease psychosis, or PDP, through a combination of best-in-class virtual engagement and in-person activities. Our second pillar is delivering on the dementia-related psychosis or DRP opportunity, a potential second indication representing a tenfold increase in the addressable market size for New Placid. And third, we are developing innovative new treatments by advancing our development pipeline and acquiring new assets. Let's review in greater detail starting on slide six. For the third quarter of 2020, New Placid achieved $120.6 million in net sales, A 27% year-over-year increase driven by strong commercial execution. This is a direct result of our ability to successfully pivot and execute in these uncertain times, as well as a testament to the importance of treating PDP. As a result of our continued performance in 2020, we are reiterating our full-year net sales guidance to be between $430 to $450 million, representing 30% year-over-year growth at the midpoint of the range. We are well prepared to achieve the long-term market opportunity for nucleoside and PDP and look forward to the addition of the DRP indication. Let's move to the DRP opportunity on slide seven. We are excited that Pimivanserin could be the first and only FDA-approved medicine for the treatment of dementia-related psychosis. Psychosis is associated with serious consequences in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality. Dementia related to hallucinations and delusions represent a high burden for patients and for caregivers. We are confident in both the efficacy and safety data supporting our supplemental NDA and will continue to work with the FDA to facilitate their review with a BDUFA date of April 3, 2021. We continue to make important progress in our late-stage development pipeline as shown on slide 8. with ongoing Phase III studies with Pimivanser for the treatment of negative symptoms of schizophrenia and with Trufenatide for the treatment of Rett syndrome. As part of our third strategic pillar, we remain focused on expanding and diversifying our development pipeline by investing in new treatments. Earlier this year, we brought in two very exciting investigational programs with the potential to bring differentiated approaches to areas of significant unmet need. In the spring, we in-licensed a muscarinic receptor program including ACP319 from Vanderbilt University. In this program, we are focused on improving cognition and neuropsychiatric symptoms through an ongoing research collaboration with Vanderbilt. Over the summer, we acquired Sursa Therapeutics, which is advancing first-in-class non-opioid candidates for the treatment of acute and chronic pain and a portfolio of earlier stage molecules focused on neurodegenerative disorders. Finally, I'd like to share one more positive update, which will be disclosed in the 10Q we are filing later this afternoon. We're pleased to report that the Department of Justice notified us recently that it has concluded its investigation of the company and will not be taking any further action. And with that, I will now turn it over to Michael to discuss our commercial performance and highlights.