ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to Arcadia Pharmaceuticals' second quarter 2023 financial results conference call. My name is Jada, 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 Jessica Tizen, Associate Director 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 second quarter 2023 earnings. Joining me on the call today from Acadia are Steve Davis, our Chief Executive Officer, who will provide some opening remarks, followed by Brendan Tien, our Chief Operating Officer and Head of Commercial, who will discuss the debut launch and new plaza execution. Doug Williamson, our head of research and development, will provide an update on our pipeline programs, and Mark Schneier, our chief financial officer, will review the financial highlights. Steve will then provide some closing thoughts before we open the call up for your questions. In addition, Kathy Bishop, our head of rare disease and external innovation, will be available for the Q&A session. We are using supplemental slides, which are available on our website's events and presentations section. Before proceeding, I would like to remind you that during our call today, we will be making several 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 several risks and uncertainties that may cause results to differ materially. These factors and other risks associated with our business can be found in our filings made at 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, Jess. Good afternoon, everyone, and thank you for joining us. Please turn to slide five. Acadia is entering a transformational period of growth as we continue to execute across all strategic priorities. First, New Plaza is an increasingly cash flow positive franchise and is the financial foundation to our business. Our real world evidence studies, which we began rolling out at the beginning of the year, have had a positive impact on new patient starts. And despite a contracted Parkinson's disease market, New Plaza continues to gain market share and outpaced new patient starts over other antipsychotics used off-label in the PDP market. Second, the launch of Debut is off to an exceptional start. We are seeing high demand and broad reach since U.S. commercial availability on April 17th. We continue to see a broad distribution of prescriptions written across all account types, including high-volume institutions and community practices, in addition to centers of excellence. As Brendan will discuss further in his section, we are very pleased to be receiving highly positive caregiver feedback regarding the benefits they are seeing. In addition, we are receiving positive feedback from healthcare providers and caregivers regarding the level of support they are receiving through our AcadiaConnect services, and we're seeing these efforts translate into sustained demand. Third, last month we announced our expanded licensing agreement for Tropenotide, and we now have worldwide rights to the assets. The successful launch of Debut in the U.S. underscores the opportunity we have to execute our global strategy. We expect to file a new drug submission for Trophinatide in Canada in the next 18 months, and we'll engage with European and Japanese regulators soon. There is a significant unmet medical need worldwide and no approved treatment for Rett syndrome outside of the United States. Incidence rates around the world are similar to those in the U.S. We estimate prevalence in Europe and UK combined to be between 9,000 and 14,000 patients. Based on birth rates, mortality rates, and other data, we expect the prevalence in Japan to be between 2,000 and 3,000 patients. Fourth, we have multiple late-stage programs with near-term milestones, including our Phase III Advanced II study of Pimivanserin in negative symptoms of schizophrenia, where we have now completed enrollment and expect top-down results in the first quarter of 2024. We have a phase two study of ACP204 in Alzheimer's disease psychosis that's expected to begin in the fourth quarter. Later in his section, Doug will discuss more about how that study will roll seamlessly into two phase three studies, all three of which could potentially support an NDA submission. And ACP101 is also expected to start a phase three trial in Prader-Willi syndrome in the fourth quarter of this year. Fifth, we have a deep early-stage portfolio that includes disclosed and undisclosed programs focused on neuropsychiatric and rare disorders, and we remain active in business development to further expand our portfolio. As an important side note, through the success of our debut in New Plaza franchises, our business has now reached cash flow neutrality. Let's turn to New Plaza on slide six. The New Plaza franchise has been cash flow positive going back to 2019, And we've generated increasing cashflow from this franchise each year since then by focusing on both top and bottom line, inclusive of reducing expenses by over $100 million when comparing 2021 results to our expectations for 2023. Our second quarter performance of $142 million in net sales was driven by an increase in new patient starts across both office-based and long-term care channels with particularly strong performance in LTC. As we've laid out previously, there are two dynamics which we believe can contribute to top-line growth for our new Placid franchise. One is the awareness and understanding by healthcare professionals of the three real-world studies that demonstrate the benefits of Pimivantrin compared to off-label atypical antipsychotics. As Brendan will elaborate further in his section, it's clear that these studies are gaining traction as evidenced by an increase in our market share of new-to-therapy patients for PDP. And second is our ability to continue to grow this year despite no significant improvements in Parkinson's disease market dynamics. Let's turn to slide seven to discuss our pipeline highlights. Here we have a big picture overview of our two commercial and numerous early stage and late stage pipeline programs. Each of these contribute to our leadership in the development and commercialization of new medicines for central nervous system disease and shape our long-term growth opportunities. We have phase three programs underway in both negative symptoms of schizophrenia and Prader-Willi syndrome. We also have a phase two slash three program quickly getting underway in Alzheimer's disease psychosis. And behind that, we have a rich pipeline of early stage disclosed and undisclosed programs that position us for long-term growth. I'll now turn it over to Brendan to provide additional insights on our debut launch execution and Nucleus' commercial performance starting on slide eight.