Alkermes plc

Greetings and welcome to Alchemy's first quarter 2025 financial results conference call. My name is Maria and I'll be the operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require an operator assistance during the call, please press star zero from your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may now begin.

Good morning. Welcome to the Alkermes PLC conference call to discuss our financial results and business update for the quarter ended March 31st, 2025. With me today are Richard Pops, our CEO, Todd Nichols, our Chief Commercial Officer, Blair Jackson, our Chief Operating Officer, and Dr. Craig Hopkinson, our Chief Medical Officer. A slide presentation along with our press release, related financial tables, and reconciliations of the gap to non-gap financial measures that we'll discuss today are available on the investor section of Alkermes.com. We believe the non-GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see slide two of the accompanying presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC For important risk factors, the codes cause our actual results to differ materially from those expressed or implied in the forward-looking statement. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A, and I'll turn the call over to Richard for some opening remarks.

Thank you, Cindy. Good morning, everyone. I'm going to start by recognizing the passing of our colleague and friend, Ian Brown, following a courageous battle with cancer. Known to many of you, Ian represented the best of our company in many ways through his intellect and his professionalism, his kindness and his humanity, and his sense of humor. I want to thank all of you who sent along your condolences and remembrances. It meant a lot to all of us here. As you know, Blair, Jackson has been serving in the role of interim principal financial officer since Ian went on medical leave in early 2024. Blair's done an excellent job among his other responsibilities and will continue to serve in that role as we look now to identify Ian's successor. So with that said, let me say that we have a few things to cover this morning and I'm going to dive right in. On today's call, Todd's going to start with an overview of the performance of our commercial products. We'll review the financial results for the quarter and provide some insights regarding our positioning within the current macroeconomic conditions. And given the exciting progress we're making across the Ericsson portfolio, Craig Hopkinson, our head of R&D and CMO, will provide an update. You'll be hearing from him more going forward as we move into a data-rich phase of the ALCS 2680 program. So here's my perspective on where we stand in May 2025. The summary is that we're well-positioned and we're right on plan. Our first quarter commercial performance was solid and slightly ahead of expectations that we provided on our last earnings call. Each of our medicines has a differentiated value proposition, and we're focused on maximizing the potential of DiBalvi, Aristata, and Vivitrol in their respective markets. Financially, our first quarter results were on plan, and this morning, we reiterated our financial expectations for the year. Across the commercial and financial elements of the business, we continue to focus on driving growth, driving profitability. The exciting new developments are happening in R&D. This will be a pivotal year across the orexin-2 development landscape, and Alkermes is at the forefront of development in this exciting potential therapeutic category. Our ALKS 2680 Phase II program is designed to generate a substantial data set that characterizes the efficacy, safety, and tolerability of a wide range of doses across narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. As we had hoped and anticipated, as we activated sites around the world and investigators gained experience with our study, the phase two program began to accelerate and it's advancing now with real momentum. The NT1 study, Vibrance 1, is now fully enrolled. We now expect top line results early in the third quarter. The NT2 study, Vibrance 2, is enrolling very well. We expect to complete enrollment mid-year with data to follow in the fall. The results of Vibrance 1 and Vibrance 2 will represent two of the most substantial data sets to be generated in this therapeutic category to date, and will provide important information as we advance the program toward planned phase three studies. We are on the cusp now of potentially transformative data, and we're planning for an exciting second half of the year. Finally, with respect to the macro environment, Boyer will give you some details, and I'll be happy to answer questions you might have. But in summary, we're paying attention to two main topics, Medicaid changes under reconciliation and FDA. With respect to potential tariffs and foreign reference pricing, we are in an advantageous position because we manufacture all of our proprietary products in the U.S., in the state of Ohio, and we do not commercialize them in markets outside the U.S. So with those introductory comments, I'll turn it over to Todd to take us through the commercial results for the first quarter.