ACADIA Pharmaceuticals Inc.

Ladies and gentlemen, and welcome to the Acadia Pharmaceuticals conference call. My name is Shannon, and I'll be your coordinator for today. I would now like to turn the presentation over to Al Khaldani, Senior Vice President of Investor Relations and Corporate Communications 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 2024 earnings. Joining me on the call today from Acadia are Catherine Owen-Adams, our Chief Executive Officer, who will provide some opening remarks, followed by Tom Garner, our Chief Commercial Officer, who will discuss our strong commercial brands, debut in New Plaza. Also joining us today is Elizabeth Thompson, Ph.D., Executive Vice President and 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. Katherine 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 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 2025 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 unique 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 Catherine for opening remarks.

Thank you, Al. Good afternoon, everyone, and thank you for joining us. Now five months into my role as CEO of Acadia, I'm excited to share an update on the significant progress we have made. During our last call, my first with Acadia, I expressed my enthusiasm for the company's strong foundation and the potential of our pipeline. Since then, the developments we've achieved have only reinforced my confidence in our future. These recent developments include delivering strong financial results in both commercial brands, as we will detail later in the call, with revenue guidance targeted at over $1 billion in the US in 2025, with volume growth for both brands. Announcing new commercial leadership with Tom Garner joining Acadia as our new Chief Commercial Officer. submitting our marketing application authorization with the European Medicines Agency for Triphenatide, setting us up for our first approval outside North America. Announcing our second indication, we intend to study with ACP204 Lewy Body Dementia Psychosis, adding to our pipeline an exciting new neuroscience program in ACP711 for the treatment of essential tremor, providing greater transparency into the depth and diversity of our pipeline in both neuroscience and neurorare diseases by disclosing more details about our programs, culminating in our announcement of Acadia's first R&D Day to be held on June the 25th. And further strengthening our balance sheet with the sale of our priority review voucher. Acadia's corporate strategy is anchored by our neuroscience and neurorare disease franchises, and we plan to deliver long-term growth by expanding these franchises, including exploring investments into additional adjacencies in rare disease. We also expect to execute some important value-creating milestones in 2025 and 2026, which I will detail later in the call. Now turning to our commercial highlights. Our commercial brands finished the year strong with record quarterly revenues and are both poised for volume and revenue growth in 2025. I'll begin with Debut. which generated sales of 96.7 million in the fourth quarter, up 11% year over year, and 6% sequentially. For the full year, debut sales were 348.4 million, up from 177.2 million in 2023, which was debut's launch year. While our base of patients on therapy remains stable, we have continued confidence in the opportunity to grow this brand, both in the US and abroad. Tom will detail our key initiatives to accelerate patient and volume growth in the US and our expectations for initial revenues from outside the US. Now turning to New Placid, which generated sales of $162.9 million in the fourth quarter, up 13% year-over-year, and four-year sales of $609.4 million, up 11% from the prior year. We are very pleased with continued strength of New Placid growth, driven primarily by volume, as we begin to see the initial impact of our direct-to-consumer and unbranded campaigns, which were launched in mid-August of 2024. These efforts have boosted traffic to our disease awareness and new pleathered websites, sparking more patient-doctor discussions about Parkinson's-related hallucinations and delusions. Turning next to our pipeline. As I noted at the outset, Acadia's robust pipeline was a key factor in my excitement to join the company. Last month, we introduced this slide at an investor conference, providing a more in-depth look at our diverse pipeline. I'd like to highlight a few key observations. Our pipeline is significantly broader than was previously disclosed, with programs spanning neuroscience, rare disease, and areas where the two intersect. These product candidates cover all stages of development, from discovery to phase three. leveraging a diverse range of unique mechanisms of action. Furthermore, the indications we are pursuing align with our mission to bring new treatment options to underserved patient communities, while also representing substantial market opportunities with either first-in-class or potential best-in-class therapies in areas of high unmet medical need. We also look forward to sharing more information about our programs at our first ever R&D Day, planned for June the 25th of this year in New York. During the fourth quarter, we also strengthened our executive leadership, in particular on the commercial side. I'd like to introduce Tom Garner, our new Chief Commercial Officer, who will provide additional color on the performance of our commercial brands. Tom joined us in December and has hit the ground running, already making a significant impact on our commercial organization. Having previously worked together successfully at Bristol-Myers Squibb, I'm pleased to be collaborating with him once again.