Alkermes plc

Greetings, and welcome to the Alkermes Second Quarter 2025 Financial Results Conference Call. My name is Rob, and I'll be your operator for today's call. All participant lines will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press star zero from your telephone keypad. Please note that this conference is being recorded. I'll 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 June 30th, 2025. With me today are Richard Pops, our CEO, Blair Jackson, our Chief Operating Officer, Todd Nichols, our Chief Commercial Officer, Dr. Craig Hopkinson, our Chief Medical Officer, and Dr. Marcus Yance, Vice President of Clinical Development. A slide presentation along with our press release, related financial tables, and reconciliations of the GAAP to non-GAAP 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 that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. 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 now let's turn the call over to Richard for some opening remarks.

Thank you, Sandy. Good morning, everyone. We had a very successful second quarter. Our commercial and financial performance were strong. And last week, we took another major step forward in our pursuit of a medicine that has the potential to transform the treatment of narcolepsy. Now, midway through 2025, we're on track to deliver on our key objectives across the business. In commercial, we had planned for strong sequential growth, and we exceeded our expectations in the second quarter. This result was driven by excellent operational execution by a seasoned commercial team. With sustained profitability now, no debt, and more than a billion dollars of cash, we're in a strong financial position with significant optionality. It's clear to us now that the future growth of the business can be accelerated by the development candidates now in our pipeline. Last week, we reported positive top line results from Vibrance One. This was our first phase two study of Elixir Rexton, which you've formerly known as ALX2680, in narcolepsy type 1. Vibrance 1 was successful and a critical study in the development of our Rexton portfolio, obviously for the efficacy and safety data it yields, but also for the operational foundation it provides for the Phase 3 program. Now, if you think back a year ago, we had data from our Phase 1B study of elixirexin that suggested robust efficacy and a generally well-tolerated profile based on single-day exposures across a range of doses in small cohorts of patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. These data were critical in defining the initial clinical profile and dosing range for elixirextin. This was step one. Step two is to confirm and extend these observations in multi-week, multi-dose, phase 2 outpatient studies. Vibrance 1 in patients with narcolepsy type 1 is the first of these studies. Now we have randomized, placebo-controlled, six-weeks, multi-dose data in hand from more than 90 patients with NT1. We've now answered key questions in Phase 2 with rigorous assays across larger cohorts of NT1 patients over a longer period of time. These data and insights will be fundamental in preparation for Phase 3. So here are the key findings from the study at the top line. First, the results demonstrated a significant effect on wakefulness and a generally well-tolerated profile. This was our pretest hypothesis, and the data were in line with our expectations. Second, the study provided entirely new and exciting findings relating to fatigue and cognition. These are among the most disruptive symptoms patients with narcolepsy experience, and they're distinct from excessive daytime sleepiness. In this study, elixirextin showed robust and clear improvements on validated patient-reported measures. Our view is that demonstrating effects in these domains establishes a new standard in the development of REXIN-2 receptor agonists in narcolepsy. These emerging data also further support our hypothesis that the REXIN system can be harnessed to address other neuropsychiatric and neurological conditions. We have two additional REXIN candidates that we plan to develop for conditions beyond central disorders of hypersomnolence. We initiated first in human studies for one of these candidates, ALKS 4510. We plan to advance the second candidate, ALKS 7290, into the clinic later this year. So for today, Craig and Marcus will take you through the top line results of Vibrance One, with significantly more detailed data to be presented at the upcoming World Sleep Meeting in September. But first, Blair and Todd will review the financial and commercial performance of the business for the second quarter. And with that, I'll hand the call over to Blair.