ACADIA Pharmaceuticals Inc.

Thank you for standing by. My name is JL, and I will be your conference operator today. At this time, I would like to welcome everyone to the Acadia Pharmaceuticals Incorporated fourth quarter earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again. I would now like to turn the conference over to Alex. Kildani, Senior Vice President of Investor Relations and Corporate Communications. You may begin.

Good afternoon, and thank you for joining us on today's call to discuss Acadia's fourth quarter and full year 2025 financial 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 Tom Garner, our Chief Commercial Officer, who will discuss our commercial brands, Debut and New Placid. 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. Katherine will then provide some closing thoughts before we open up the call to your questions. We are using supplemental slides, which are available on our website under the Events and Presentations section. On today's call, both GAAP and non-GAAP financial measures will be discussed, including non-GAAP New Plaza net sales and non-GAAP total revenues. The non-GAAP financial measures that are also referred to as adjusted financial measures are reconciled with the most directly comparable GAAP financial measures in our earnings press release and slide presentation, which has been posted on the investor's page of the company website. 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 as circumstances change, except as required by law. I'll now turn the call over to Catherine for opening remarks.

Thanks, Al, and good afternoon, everyone. I'm pleased to report that Acadia delivered another strong quarter, capping off a milestone year for our company. We achieved adjusted total revenues of $298 million in the fourth quarter, up 16% from the prior year. And for the first time in our company's history, annual revenues exceeded $1 billion, reaching $1.08 billion in adjusted 2025 revenue, which represented 14% growth from the prior year. This achievement underscores the strength of our commercial execution and positions us for sustained growth in the coming years. We are presenting adjusted revenues because during the fourth quarter, we received our Inflation Reduction Act invoices from CMS for New Placid, which were higher than anticipated and required a non-recurring accounting change in estimates that you see reflected in our financials. Mark will walk you through the details later in the call. As a result, we delivered adjusted New Placid net sales of 189 million in the fourth quarter and 692 million for the full year. These results were up 17% and 15% respectively, and in terms of volume, represented 13% in the fourth quarter and 9% for the full year, together demonstrating the continued strength of New Placid and further reinforcing our confidence in its long-term growth trajectory. So now looking forward to 2026, we expect new plaza net sales of 760 to 790 million, which would represent between 10% and 14% growth over 2025 adjusted net sales, placing the brand on a strong trajectory towards our expectation of achieving blockbuster status with 1 billion of net sales in 2028. Turning to debut, we delivered net product sales of 110 million in the fourth quarter and 391 million for 2025, representing 13% and 12% respectively year-over-year sales growth. This growth was driven primarily by our expanded reach into the community physician setting in the U.S. and our ex-U.S. main patient supply programs, including countries outside the European Union where we're seeing strong interest to access Debut. We're excited about the launch of Debut Sticks, our new powder formulation, which is still in the very early stages, but already generating significant interest from both healthcare providers and caregivers. Tom will share more details on how this new formulation is being received and the opportunities we see ahead. I do want to briefly address the regulatory developments in the EU. As we shared, following our oral explanation to the Committee for Medicinal Products for Human Use, or CHMP, which we gave to support our Drafinitide marketing application, we were informed that the outcome was a negative trend vote. Liz will provide details on our plan to request a reexamination subject to the formal opinion. Our commitment to advancing access to Drafinitide in the EU remains unchanged. Importantly, our name patient supply programs remain active, ensuring patients maintain access to treatment as we move through the regulatory process. For our 2026 debut guidance, we expect global net sales between $460 and $490 million, which would represent between 18% and 25% growth over 2025, driven by contributions from the STIX launch in the U.S. and continued growth of our name patient supply outside the US. Due to the current status of our application within the EMA, this 2026 guidance does not include potential commercial sales that would result from this regulatory approval. However, it does include contributions from our global name patient supply programs, including countries within the EU where we continue to see strong interest. Longer term, we continue to project 2028 global net sales for debut of 700 million, inclusive of the EU, and we'll update our expectations after clarity on the final EMA opinion. Just for perspective, of our projected 700 million in 2028 sales, the EU sales represent less than 15% of the total, meaning we have ample opportunity for growth ahead under any scenario. Turning to our robust R&D pipeline, we are excited for the phase two readout of remlifanthrin in the August through October 2026 timeframe, as this presents a key event for our company this year. Beyond that, we see several important catalysts, which Liz will detail. Importantly, we have four unique molecules targeting large addressable markets with a combined full peak sales potential of $11 billion. Approximately $4 billion of that potential is specifically attributable to remlifanserin across both the Alzheimer's disease psychosis and Lewy body dementia psychosis indications, highlighting the transformative potential this asset represents for Acadia's future growth trajectory. I'll now turn the call over to Tom for an update on our commercial brands.