ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to Acadia Pharmaceuticals' fourth quarter and full year 2021 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 toward the end of today's call. If at any time during the call you require assistance, please press star followed by zero, and the 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 fourth quarter and full year 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 2021 financial performance, a review of our business, and our outlook for 2022. Following Steve, Mark Schneier, our Chief Financial Officer, will then discuss our financial results and guidance. Also joining us today is Brendan Thien, our Chief Operating Officer, Head of Commercial, who will provide updates on our commercial initiatives. Dr. Serge Stankovich, our President, will then discuss our two new drug applications and our pipeline progress before turning it back to Steve for final remarks and opening up the call 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, 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. 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. To deliver on our mission, we are focused on three strategic pillars. First, drive growth of new clients and franchise where we continue to perform at a high level. Second, advance our three late-stage opportunities by submitting applications for new approvals for Pimivanserin in Alzheimer's disease psychosis, or ADP, and for terpenetide in Rett syndrome, and completing enrollment in our Negative Symptoms of Schizophrenia program, also with Pimivanserin. And third, develop the next wave of CNS breakthroughs with our early-stage pipeline while continuing to pursue strategic business development opportunities. Starting on slide six, For the full year of 2021, we achieved net sales of $484.1 million, which represents 10% year-over-year revenue growth. During 2021, we grew both total prescriptions and market share as we continued to outperform the top neurology, Parkinson's, and long-term care drugs. We achieved this despite operating in a disproportionately affected Parkinson's disease market, where in-person Parkinson's patient visits remained down approximately 20%. and occupancy rates in long-term care facilities remain down approximately 15% compared to pre-pandemic levels. Our strong performance during this time underscores our ability to grow the brand. As the pandemic conditions normalize and overall PD market dynamics improve, we are poised to accelerate this growth. As we look ahead in 2022, we expect to see improvement in the infection rates of COVID-19, but more importantly, as it relates to the Parkinson's market, We will be looking for a normalization of staffing turnover and reduction of staffing shortages in both the office space and long-term care settings. We'll also be focused on the rate at which Parkinson's patients are seeing their physicians in person. As Mark will speak to in a minute, for the full year 2022, we expect net sales to be between $510 and $560 million. What we achieve within this range will be a function of read-through from the pandemic conditions and our ability to continue to outperform the top neurology, Parkinson's, and long-term care drugs. Now let's turn to our three late-stage opportunities on slide seven. We recently announced the resubmission of our SNDA for Pimivanser for the treatment of ADP. In addition, we look forward to submitting our NDA for terpenetide for the treatment of Rett syndrome around the middle of this year. Our Alzheimer's disease psychosis resubmission provides additional analyses from two previously conducted clinical studies, Harmony and Study 019, to support a proposed indication for the treatment of ADP and is intended to address issues raised in the FDA's complete response letter. As we've previously described, this resubmission gives the FDA an opportunity to fully review our new additional analyses and through this process gives us an opportunity to make our case that Pimivanserin should be the first drug approved for the treatment of ADP. An important contextual point is that in our studies with Pimivanserin, we did not observe impairment of cognition or motor function compared to placebo, a very important consideration in this elderly and highly medically compromised population, and a historical challenge in developing drugs to treat psychosis in Alzheimer's patients. We expect this to be a Class II resubmission, which would mean the FDA will be targeting a six-month review with an action date in the third quarter. Having recently submitted, we are not yet at the point where the FDA would assign an action date. We should reach that point soon, and we'll update you as soon as they do. Regarding our NDA for terfenetide, at the end of last year, we announced positive top-line results from our Phase III lavender study of terfenetide for the treatment of Rett syndrome. Our NDA submission will be based on the Pivotal Lavender Study and its co-primary endpoints. In preparing for our NDA submission, we scheduled two meetings with the FDA. We've already met with the FDA to review the overall content and format of the clinical data to be included in our NDA submission. The second meeting, scheduled for March, will be dedicated to covering similar ground on CMC aspects of the submission. We're planning for an NDA submission around mid-year and expect a priority review with a BDUFA action date in the first quarter of 2023. Moving to our third late-stage opportunity, in our Phase III Negative Symptoms of Schizophrenia program, we have something that's very rare in this space, and that is a positive, pivotal study, our Advance One study. The negative symptoms that schizophrenia patients suffer from have proved to be the most difficult to treat. The symptoms, which generally revolve around the social withdrawal aspects of the disease versus the hallucinations and delusion symptoms, have been the largest unmet need in schizophrenia for multiple decades. And today, we still have no FDA-approved treatment for negative symptoms. With one positive pivotal study complete, we're in the process of running a second pivotal study. This is our ADVANCE-2 study. ADVANCE-2 is designed to be virtually identical to our successful ADVANCE-1 study with an important difference. In ADVANCE-1, we observed that at the highest dose tested, 34 milligrams, the drug effect was markedly higher than the statistically significant and clinically meaningful results of the overall drug-treated group, which included lower doses as well. Therefore, in our Advanced 2 study, all patients are receiving the optimal 34-milligram dose. Please turn to our pipeline chart on slide 8. Our third strategic pillar to grow our business is to develop the next wave of breakthroughs in our early-stage programs. Our early-stage pipeline is highlighted by our ongoing Phase II pain program, evaluating ACP-044 in two studies, one in acute and one in chronic models of pain, with data coming from both studies this year. And we have additional earlier-stage programs highlighted by collaborations with Vanderbilt University and Stoke Therapeutics, as well as early-stage internal programs designed to leverage the learnings of Pima-Vancerin to further our franchise and take advantage of indications we might never get to with Pima-Vancerin. Finally, we look forward to continuing to evaluate and execute business development to grow our opportunity set in CNS, further leveraging our strong R&D and commercial capabilities. With that, I will now turn the mic over to Mark to discuss our financial performance and guidance.