ACADIA Pharmaceuticals Inc.

Press star followed by zero, and a coordinator will be happy to assist you. I would now like to turn the presentation over to Mr. Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Good afternoon, and thank you for joining us on today's call to discuss Acadia's second 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 Q2 2021 financial performance and a review of our business operations. Also joining us today 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 Sankovich, 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 Presentations 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 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 will 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 review of our commercial performance, followed by some important company updates. Please turn to slide four. For the second quarter of 2021, New Placid achieved $115.2 million in net sales, representing a 5% year-over-year increase driven by sequential and year-over-year volume growth. As a result of a slower pace of pandemic recovery and a higher-than-expected gross-to-net, we are projecting net sales for the year at $480 to $515 million. Elena will discuss the gross-to-net dynamics in greater detail in her section. Let me speak to the continuing impacts of the pandemic, which impacted our growth in the second quarter. In the office-based channel, Parkinson's patients visits in the quarter were down 20% from pre-pandemic levels. This is important because many physicians are hesitant patient on a new therapy without diagnosing them first in person. So while we still grew new patient starts in the quarter, the rate of growth in the new patient starts was significantly impacted by reduced Parkinson's patient visits. In the long-term care channel, occupancy rate facilities are currently approximately 15% below pre-pandemic levels, and new admissions are down approximately 17%. For many of our patients, being in or admitted to a long-term care facility often coincides with a PDP diagnosis and thus a new patient start on new plans in. The reduction in both ongoing occupancy rates and new patient admissions continue to impact our ability to start new patients on New Plaza in the LTC setting. Despite these impacts of the pandemic on patient population, we've grown our new patient starts and our business overall. Our ability to grow despite these headwinds is further reinforced by our strong relative performance compared to other branded products in the long-term care channel. Visits long-term care facility admissions and less in-person detailing were headwinds that slowed our growth in the second quarter. These headwinds are, of course, temporal. Going forward, despite these headwinds, we expect to continue to grow our business, including sequential volume growth and new patient starts. As pandemic conditions for the Parkinson's community improve, we expect these headwinds to become tailwinds, further accelerating our growth. In addition, we have commenced several PDP growth initiatives that Amanda and Charmaine will speak to in a moment. Let's move to an update on our DRP program on slide five. We recently completed a Type A end-of-review meeting with the FDA to discuss the issues raised in the complete response letter that we received in April. Today, we'd like to share the key takeaways from that meeting. First, the FDA reaffirmed their stated position in the CRL that Pimivanserin should be studied by individual subgroups of dementia and advised us that the best path forward to conduct an additional clinical study and each of the subgroups for which we seek approval. In the meeting, we highlighted the consistent and clinically meaningful efficacy observed in the DRP population overall, as well as across individual dementia subgroups, Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, and patients with mixed pathologies. As a result of these discussions, the FDA indicated that they are open to discuss additional analyses from the HARMONY study and the 019 study, that may support a potential resubmission without conducting an additional study. We're planning to discuss analyses with the FDA at a meeting later this year. In parallel with preparations for this meeting, we will also prepare for all potential outcomes that may come from this discussion. In addition to DRP, let me highlight clinical updates as we turn to slide six. We recently completed enrollment from our phase three program for trofinetide and Rett syndrome and are on track to deliver top-line results by the end of the year. Our Phase III program for Pimivanserin for the negative symptoms of schizophrenia continues to enroll well. As a reminder, the Pivotal Advance II study was started in the third quarter of last year. Earlier this year, we initiated a Phase II study evaluating ACP-044 for postoperative pain associated with bunionectomy cert, and expect top-line results later this year. Furthermore, in the second quarter, we initiated a Phase II study evaluating 044 for pain associated with osteoarthritis. Business development continues to be a key priority for our strategy to expand our pipeline for 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 second quarter commercial performance and growth initiatives.