ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals third quarter 2021 financial results conference call. My name is Gigi, and I'll be your coordinator for today. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

today's call to discuss Acadia's third 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 Q3 2021 financial performance and a review of our business operations. Also joining us today is Brendan Tehan, our Chief Operating Officer and Head of Commercial, who will provide updates on our commercial performance. Dr. Serge Stankovich, our President, will discuss our pipeline progress and our Interim Chief Financial Officer, Mark Schneier, will then discuss our financial results in more detail before turning it back to Steve for final remarks and opening the call for your questions. I would also like to point out that we are using supplemental 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'll 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 associated with our business can be found in our filings made with the SEC. You are cautioned 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. I'd like to start with a quick recap of our commercial performance, followed by a regulatory update for BIM of Answering and a preview of our coming catalyst. Please turn to slide four. First, I'd like to take a moment to remind everyone of our announcement last week that Brendan Tien has been promoted to the position of Chief Operating Officer and Head of Commercial. Brendan has been a tremendous leader for our team, and I'm very excited to be able to further leverage his deep experience and strong capabilities. While Brendan will take you through our commercial update in greater detail in a minute, let me just say that on a macro level, the Parkinson's disease market continues to be significantly impacted as a result of the pandemic. Despite these challenges, Nuplazid has outperformed branded drugs in this space, and for the third quarter of 2021, Nuplazid achieved $131.6 million in net sales. This represents a 9% year-over-year increase with sequential and year-over-year volume growth. As shown in the graph on the left, our team has continued to execute with year-over-year and sequential growth each quarter since the beginning of the year. To be more precise, New Plaza has outperformed a market basket of top prescribed brands in neurology and Parkinson's disease in the office space setting. Similarly, New Plaza continued its strong outperformance in the long-term care channel. Our strong relative performance underscores our team's ability to adapt and find ways to grow our brand. This includes our recently launched branded campaign targeting healthcare providers, which promotes and applies its unique safety profile specifically as it relates to the Parkinson's community. On the patient and caregiver front, we're in the process of launching a new DTC campaign aimed at solving one of our biggest COVID-related challenges, which is physicians not seeing as many PDB patients in person. As such, this DTC campaign is aimed at patients and caregivers who are at home and is designed to activate them to have a conversation with their doctor about their symptoms of psychosis and potential treatment with Nucleazid. Our growth initiatives, new leadership, and strong relative performance give us confidence that we will further accelerate the growth of Nucleazid into 2022. Now let's move to our regulatory update regarding our SNDA for PIM of answering on slide five. As you recall, at our type A end of review meeting, the FDA made it clear that today they are looking at individual subgroups of dementia rather than DRP as a single group. Accordingly, they stated that they believe our best path forward is to conduct an additional study in each subgroup where we seek approval. However, at that meeting, the FDA also stated, based on additional analysis we've shared with them, that they are open to having another meeting to discuss whether there is a potential path to resubmission without an additional clinical study in any of the subgroups. This meeting is now scheduled, and we expect to be able to report on the results of the meeting around year-end. When we look at our dementia subgroup data, it is very clear that we have the most data for Alzheimer's disease, which represents somewhere between 60 and 80 percent of all dementia patients in the U.S. Our database includes two independent clinical studies providing evidence of Pimivanshin's antipsychotic efficacy in Alzheimer's disease psychosis, study 019, and the HARMONY study. Together, these studies demonstrate improvement in psychotic symptoms and reduction of risk of relapse of psychosis in ADP patients. At our upcoming meeting with the FDA, we look forward to sharing additional analyses we've done in response to feedback from the last meeting. Serge will provide more details on this opportunity in this section. As we look ahead, I'd like to highlight some important near-term catalysts, as shown on slide six. First, as I've noted, we look forward to providing an update from our meeting with the FDA around year-end. Second, we expect to announce top-line results from Lavender, our pivotal phase three study for tropinotide and Rett syndrome, later this quarter. And third, we expect to announce top-line results from a phase two proof-of-concept study evaluating ACP in postoperative pain following bunionectomy surgery in the first quarter of 2022. Finally, our company is well poised for further expansion. We have a healthy balance sheet, a growing revenue base, and best-in-class in-house R&D and commercial teams. Business development continues to be a key priority of our strategy, and we continue to be very active on that front. I would now like to turn the call over to Brendan to discuss our commercial performance.