ACADIA Pharmaceuticals Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the third quarter 2024 Acadia Pharmaceuticals Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Al Kildani, Senior Vice President, Investor Relations and Corporate Communications. Please go ahead.

Thank you. Good afternoon and thank you for joining us on today's call to discuss Acadia's third quarter 2021. 24 earnings results. Joining me on the call today from Acadia are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks, followed by Brendan Tan, our Chief Operating Officer and Head of Commercial, who will discuss our strong commercial franchise's debut in New Plaza. Also joining us today is Liz Thompson, PhD, Executive Vice President, Head of Research and Development, who will provide an update on our pipeline programs, and Mark Schneier, our Chief Financial Officer, will review the financial results. Catherine will then provide some closing thoughts before we open up the call for your questions. We are using supplemental slides, which are available on our website's events and presentation section. Before proceeding, I would like to remind you that during our call today, we will make 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, future results, and financial guidance, 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 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, and we assume no obligation to update or revise these forward-looking statements as circumstances change, except as required by law. I'll now turn the call over to Katherine for opening remarks, beginning on slide four.

Thank you, Al. Good afternoon, everyone, and thank you for joining us. By way of introduction, I'm Katherine Owen-Adams, and it's an honor to be speaking with you as the new CEO of Acadia. I want to take a few moments to share a little about my background and how it aligns with Acadia's goals and explain why I felt so drawn to join Acadia. To begin, I have over 30 years of experience in the pharmaceutical industry. most recently serving as Senior Vice President and General Manager of the US business at Bristol Myers Squibb. And prior to that, leading their international major markets business. Before that, I spent 25 years at Johnson & Johnson, working in both their pharma and med tech businesses in the EU and US. Throughout my career, I've led teams that have successfully launched and managed drugs across many therapeutic areas, including rare disease and neurology. In the last five years, I've had the privilege of being involved in nine drug launches in the US and internationally, including a number of successful rare disease launches. I joined Acadia because I was excited by the foundational business and the future potential of the pipeline. I'm both inspired and humbled to have the opportunity to lead Acadia in advancing therapies that can make a real difference in people's lives. As I look toward that future, I see incredible opportunities ahead to grow our current portfolios and advance the innovations in our pipeline, including two late-stage assets serving new communities of patients with high unmet medical needs. I see significant potential to enhance shareholder values as we continue to execute and evolve our commercial priorities and advance our pipeline assets. Please turn to slide five, where I will elaborate a little on each of these areas and underline why I chose to join Acadia against our three core pillars. First, on the commercial front, we have two growing franchises, which together, based on our Q3 results, are now tracking to over $1 billion in annualized sales, an extraordinary milestone for a biotech company of our size. Second, our robust pipeline includes two late-stage assets in Prader-Willi syndrome and Alzheimer's disease psychosis, complemented by many promising early stage programs. And third, our financial strength is fueled by our positive cash flows and a growing cash balance, which now stands at $565 million. I'll now briefly highlight our commercial and R&D pillars before handing off to our leaders, who will dive deeper into the details. Turning now to slide six. Beginning with debut, where we've had another solid quarter, generating sales of $91.2 million, up 36% year-over-year and 8% sequentially. I'd like to take this opportunity to share some high-level observations on debut based on my experience with multiple rare disease launches and to give some context for our launch results to date. Six quarters in, with $429 million generated in sales, I think we can say this has been a successful launch. Every rare disease launch is unique, but I have observed some key commonalities with debut. They are complex, highly situational, and involve coordination of lots of moving parts within the healthcare system. Especially important is the focus on the patient's journey, both to start and stay on therapy, and concentrating on how this journey is fully supported. We've reached a steady state of new patient starts with debut and have strengthened our focus on growing this in the next several quarters. This will take time, and growth will be driven by continuing to lean in to the breadth of our clinical data, illustrating and describing to HCPs the impact debut has on patients, bringing to life the scoring systems used in clinical trials, and generating real-world experience and insights from our ongoing Lotus study. We will also continue to focus on the early part of the patient journey as families and doctors work together to find the dose for their child. I'm extremely confident about the potential for debut growth and further penetration beyond our COEs into the diagnosed patients who can benefit from its impact, both in the US and beyond. I'll now turn to New Placid, which has had an outstanding quarter with net sales of 159.2 million, up 10% year over year. These results were achieved on the basis of underlying trends we described last quarter, including the impactful real-world evidence studies and last year's label clarification, combined with what we now see as a stable Parkinson's disease psychosis market. In August, in collaboration with Ryan Reynolds, we announced our unbranded More to Parkinson's campaign to raise awareness of Parkinson's-related hallucinations and delusions. We are excited about the early impact of this campaign that we're seeing with patients and caregivers and HCPs. Separately, we launched a New Plazid direct-to-consumer campaign, which we believe will help us accelerate growth for New Plazid in 2025. Brendan will discuss these campaigns in more detail. Turning now to slide seven for a discussion of our pipeline. In addition to our successful commercial brands, Acadia's pipeline is an important reason why I was so excited to join the company, as I believe the pipeline is truly underappreciated. We have a Phase III asset in ACP101 that's being evaluated as a treatment for Prader-Willi syndrome, a rare and debilitating genetic disease with no FDA-approved treatment, where patients often have an unrelenting drive to eat called hyperphagia. Behind that in our pipeline is ACP204, our second-generation 5-HT2A blocker, where we are currently conducting the Phase II portion of the program. This exciting asset has the potential to extend and expand our neuropsychiatry franchise. Both of these drugs will allow us to offer new options for patients in underserved communities with patient numbers larger than our current portfolio. We also have a number of exciting earlier stage assets we look forward to discussing more in the future as they advance in their development. We're also actively pursuing opportunities to expand this pipeline further through business development. which remains a strategic imperative of the company and an important focus for me as we look to set our growth trajectory for the future. I'll now turn it over to Brandon to discuss our commercial performance with these brands, beginning on slide eight.