ACADIA Pharmaceuticals Inc.

Welcome to Acadia Pharmaceutical's first quarter 2021 financial results conference call. My name is Mary and I will be your coordinator for today. At this time, all participants are in a 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, Mary. Good afternoon, and thank you for joining us on today's call to discuss Acadia's first quarter 2021 financial results. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide an overview of our Q1 2021 financial performance and a review of our business operations. Also joining us on today's call is Amanda Morgan, our Chief Revenue and Customer Officer, and Charmaine Likens, Global Product Planning and Chief Marketing Officer, who will provide updates on our commercial performance. Dr. Serge Sankovic, our President, will discuss our pipeline progress, and 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 are 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 meanings 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 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 four. We remain steadfast in our commitment to our mission and to executing on our three strategic pillars to create long-term growth. First, driving continued growth of Nuplizit for patients with Parkinson's disease psychosis or PDP. Second, delivering on the dementia-related psychosis or DRP opportunity. And third, developing the next wave of breakthrough therapies by advancing our development pipeline and acquiring new assets. Let's review our Q1 results in greater detail, starting on slide five. For the first quarter of 2021, Nuplizit achieved $106.6 million in net sales. This represents an 18% year-over-year increase driven by strong year-over-year performance in the office-based setting. During the first quarter, sales and appliances were negatively impacted by the post-holiday spike of COVID-19 and ongoing conditions relating to the pandemic. As we look ahead, we observed improvements related to the pandemic in the latter part of the first quarter and into the beginning of the second quarter. And based on these indicators, we are projecting continued growth throughout the year, and reiterating our net sales guidance for fiscal year 2021 at $510 to $550 million. Let's move to an update on our DRP program on slide six. We remain committed to bringing PIM of answer into the DRP patient community. In April, we announced that the FDA issued a complete response letter, or CRL, regarding our supplemental new drug application for dementia-related psychosis. We look forward to a constructive dialogue with the FDA in our Top A meeting, where we plan to discuss the CRL and a potential path, approval path, for PIM of answering. We're prudently planning and preparing for multiple scenarios based on what we learn at this meeting. I want to remind you of the significant unmet need that remains in this disease. Current treatment of DRP involves the use of off-label antipsychotics, which carries significant risks for this often frail and elderly patient population, including worsening of cognition, and impairment of motor symptoms. We've heard both publicly and privately from many physicians, caregivers, and concerned family members who have made their voices heard on this critically important matter. We're further encouraged by the public statements made by patient advocacy groups such as Us Against Alzheimer's, the Lewy Body Dementia Association, and Alzheimer's Association. We all recognize that without an FDA-approved treatment, the burden of DRP remains significant. In addition to DRP, we're focused on developing and expanding our pipeline of innovative new programs across multiple therapeutic areas, as shown here on slide seven. Our phase three program for terpenetide remains on track to deliver top line results by the end of the year. And our phase three program for pimevanserin for the negative symptoms of schizophrenia continues to enroll well. We recently initiated a phase two study evaluating ACP044 for postoperative pain following bunionectomy surgery. and expect top line results by year end. In the second quarter, we plan to initiate an additional phase two study evaluating ACP044 in pain associated with osteoarthritis. Business development continues to be a key priority of our strategy to expand our pipeline, fuel long-term growth, and bring new therapies to patients with high unmet needs. I would now like to turn the call over to Amanda and Charmaine to discuss our first quarter commercial performance and growth initiatives.