ACADIA Pharmaceuticals Inc.

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Acadia Pharmaceuticals Second Quarter 2024 Financial Results 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 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at Acadia. Please go ahead.

Thank you, Daniel. Good afternoon, and thank you for joining us on today's call to discuss Acadia's second quarter 2024 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 Tehan, our Chief Operating Officer and Head of Commercial, who will discuss our commercial franchises, Debut and New Plaza. Also joining us today is Elizabeth 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, who will review the financial highlights. Steve will then provide some closing thoughts before we open up the call to your questions. In addition, Parag Neswani, Senior Vice President, Trophinatide Rare Disease Franchise, as well as Kimberly Mannard, Senior Vice President Global Strategic Planning and Execution 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, 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

except as required by law i'll now turn the call over to steve for opening remarks thank you al good afternoon everyone and thank you for joining us please turn to slide five the foundation of acadia's business is built on our two commercial products it applies it for the treatment of hallucinations and delusions associated with parkinson's disease and debut for the treatment of red syndrome together these Commercial franchises delivered $242 million in revenues for the second quarter. In addition to these successful commercial products, we have a deep and growing pipeline headlined by our Phase III Prader-Willi syndrome program and our Phase II, Phase III program in Alzheimer's disease psychosis. Our two profitable franchises drove 46% year-over-year revenue growth and provided Katie with a strong financial foundation. We are a cash flow positive company and now have over $500 million in cash with no debt. This gives us a great deal of confidence in our ability to fund future growth by advancing our current pipeline programs as well as investing in future business development opportunities. Please turn to slide six. I'll now discuss some highlights from each of our commercial products that Brendan will expand upon further in his section. I'll begin with Debut. In the second quarter, Debut Net Product Sales were $84.6 million, up 11% sequentially. During the quarter, we've returned to growing active patients on therapy. Today, we are at 900, which is back to where we ended 2023 following the surge of new patients we experienced soon after Debut's launch, and is 66 patients above our low point late in the first quarter. Consistent with our expectations, Numerical discontinuations dropped significantly in the quarter, with the rate of weekly discontinuations decreasing 46% in the second quarter versus the first quarter. New patient starts rebounded in the quarter, but with the rate of weekly starts increasing 12%, this rate of growth was slower than projected. So while things are moving in the right direction, they have not moved as fast as we anticipated. As a consequence, and as Mark will discuss in his section, we're lowering our guidance range for debut for the year to $340 to $370 million. Brendan will discuss in his section, our outlook for the remainder of the year and beyond. Now turning to new plans. Net product sales were up 11% in the second quarter of 2024 over second quarter of 2023 to $157.4 million. For the first half of 2024, Net product sales were up 10% compared to the first half of 2023. There are two undercurrents supporting this growth. First, the Parkinson's disease psychosis market, which was hit very hard during the pandemic, has now stabilized. Second, and more importantly, we're getting very good traction on the real-world evidence studies we've previously discussed and on a positive label change announced late last year, clarifying that Nucleazid can be used in Parkinson's disease psychosis patients who also have dementia. Our performance year to date and the favorable undercurrents I've just described have led us to increase our annual sales guidance for Nucleazid in 2024 from a previous range of $560 to $590 million up to a new range of $590 to $610 million. Before I leave Nucleazid, I want to touch on one other important point. Our market research demonstrates that the awareness of hallucinations and delusions dropped drastically during the course of the pandemic and since, which means patients many times may be experiencing these symptoms but do not raise them with their doctor. This gap creates an opportunity to raise that awareness in a market that is now stabilized. As Brendan will describe, we are initiating a targeted campaign to close the hallucinations and delusions awareness gap and capitalize on this opportunity. Our new flagship franchise has never been in a stronger position, and we look forward to sharing more details about our growth initiatives. Let's turn to slide seven. Before giving an overview of our current products and pipeline, I'd like to take this opportunity to officially introduce Dr. Elizabeth Thompson as our Executive Vice President, Head of Research and Development. Liz is a preeminent drug research and development leader with extensive experience, and we're thrilled to have her on board. Liz joins us from Amgen, where she served as Executive Vice President, Research and Development Rare Disease, following its acquisition of Horizon Therapeutics. Turning to our products and pipeline, as you heard, both New Pleasant and Debut form the growing core of our commercial business. In addition to these successful commercial franchises, we have numerous attractive late- and early-stage pipeline assets. These include ACP101 and Potter-Willie syndrome, where we are currently enrolling subjects in our Phase III study. Potter-Willie is a rare and debilitating genetic disease where patients have an unrelenting drive to eat called hyperphagia. There are no FDA-approved treatments for this condition. We're also currently enrolling our phase two, phase three program with ACP204 in Alzheimer's disease psychosis patients, another disorder where there are no approved treatments. ACP204 is our second generation 5-HT2A blocker where we are leveraging our learnings from new classes. It represents an opportunity to expand and extend our neuropsychiatry franchise. And behind that, we have a rich pipeline of early stage disclosed and undisclosed programs that position us for future growth. I'll now turn it over to Brendan to discuss our commercial performance beginning on slide eight.