Alkermes plc

Welcome to Alchemy's second quarter 2026 financial results conference call. My name is Sherry. I will be your operator for today's call. All participants will be placed on mute to prevent any background noise. If you should require operator assistance during the call, please press star zero from your telephone keypad. Please note 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 June 30th, 2026. With me today are Richard Pops, our CEO, Joshua Reed, our chief financial officer, Todd Nichols, our chief commercial officer, and Blair Jackson, our chief operating officer and incoming CEO. Hello. 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 2 of the accompanying presentation, our press release issued this morning, and our most recent annual report 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 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. Now I'll turn the call over to Richard for some opening remarks.

That's great. Thank you, and good morning, everyone. So a few months ago, we announced that I would be handing the CEO reins to Blair while continuing to serve as chairman. That transition becomes official next week, making this my final earnings call as CEO. When we made that announcement in February, it reflected my confidence in the strengths of Alkermes' leadership team and how effective we've been in positioning the company for its next major phase of growth. At the time we had a strong sense of what the coming months could bring and I'm pleased to say that many of our most optimistic expectations have become reality. So what does that mean in practical terms? I think most notably Alkermes' leadership position in orexin development is now quite clear. While our initial focus is on disorders of hypersomnolence such as narcolepsy and idiopathic hypersomnia, we increasingly see orexin as a platform with the potential to address a broad range of serious conditions where this neurocircuitry plays an important role, such as ADHD, fatigue, and other potential psychiatric, neurodevelopmental, and neurodegenerative diseases. Elixirexin is at the leading edge of that opportunity. It remains the only orexin-2 receptor agonist to have demonstrated efficacy and tolerability across both narcolepsy type 1 and narcolepsy type 2 in large phase 2 studies. Importantly, its clinical profile has shown benefit beyond improvements in excessive daytime sleepiness, with evidence of meaningful effects on cognition and fatigue as well. We've continued to share these findings, presenting the first phase 2 data set in narcolepsy type 2 at the sleep meeting in June, and most recently, the top line results of an interim analysis of our elixirexin long-term extension study in NT1 and NT2, which demonstrated sustained improvement in wakefulness and other measures for up to nine months of treatment. Today, we're actively enrolling patients in our phase three narcolepsy program, which remains on track for expected completion next year. At the same time, we're advancing elixirextin in idiopathic hypersomnia in our Vibrance 3 phase two study. Vibrance 3 adds a new element to the program with a split dose arm. The split dose regimen is designed to extend the pharmacodynamic effects of elixirextin later into the day and expand our competitive profile as we seek to meet the spectrum of needs of individual patients. We've now introduced two additional orexin compounds into clinical development, each exploring a new avenue of potentially significant commercial and medical opportunity. ALK7290 is currently enrolling adults with ADHD with initial Phase 1B clinical data expected by the end of the third quarter. represents one of the largest and most compelling potential applications of orexin biology, and we look forward to gaining our first insights into its activity in this population. In addition, Aux 4510 is planned to enter phase two in fatigue later this year, initially focused on patients with multiple sclerosis or Parkinson's disease. Fatigue remains one of the most debilitating and poorly treated symptoms across a number of neurological disorders, and we expect initial data from this program next year. Our advantageous competitive position has become increasingly evident. Today Alkermes is setting the pace in erection biology with a robust and expanding foundation of clinical evidence in narcolepsy and now generating new data sets across a number of development candidates in disease states. The result is an R&D pipeline with both depth and momentum and we enter the second half of the year with a series of meaningful clinical readouts ahead of us. But there's more to Alkermes than the pipeline. We've built a significant commercial business that serves hundreds of thousands of patients, generates substantial cash flow, and provides a foundation that allows us to invest for the future. And here, too, a number of important developments have unfolded, largely as we anticipated they could. The first relates to Levalvi, or oral antipsychotic medicine. For several years, we've been pursuing a deliberate strategy of steadily expanding access while carefully balancing the economics of our gross to net profile. This past quarter marked an important milestone in that effort. Through new contracting arrangements that we believe will help drive increased uptake of Levolvi, we expanded access strategically with three of the largest Part D plans where Levolvi is now on formula. With this expansion, Levolvi is now covered for more than 80% of insured lives. That level of access means that patients who may benefit from Levolvi have a better chance of getting it and importantly, provides a strong platform for continued prescription growth in the years ahead. The second relates to Vivitrol, our long-standing medicine for the treatment of alcohol and opioid dependence. Given its unique clinical profile and the distinct treatment settings in which it's used, we have always believed that Vivitrol would have a long commercial life. Today, more than two decades after its launch, Vivitrol continues to grow. Earlier this month, we announced the termination of our agreement with Amnial for an authorized generic of Vivitrol. So we can say now conclusively that there will be no AG for Vivitrol in 2027. As we've discussed many times before, Vivitrol's manufacturing requires specialized sterile facilities and formulation expertise. This has created meaningful barriers to entry, as evidenced by the fact that today there remains only one approved ANDA. And as we look ahead to 2027, the actual timing of that generic's market entry remains uncertain. So we see Vivitrol continuing to be a strong contributor to our commercial business in the years ahead. The third major development has been the acquisition and integration of Avidel and the Lume Rise brand. As reflected in today's results, the integration of the Avidel team and the Lume Rise business has proceeded exceptionally well. In fact, as we've gained experience with the medicine and the impact it can have on patients, our enthusiasm for its long-term potential has only increased. Importantly, last quarter we reported positive phase 3 results for lumerize in idiopathic hypersomnia, positioning us to pursue an SNDA submission and, if approved, a launch in that indication in March 2028. Taken together, these developments underscore how substantially Alkermes has evolved. From a standing start in sleep only a few years ago, we've become one of the leading companies in hypersomnolence disorders, with both a growing commercial presence in narcolepsy and a differentiated research and development platform. More broadly, we believe the biology underlying sleep and wakefulness represents one of the most compelling frontiers in neuroscience. With opportunities that may extend well beyond today's approved therapies and well beyond narcolepsy, we expect this to remain a fertile area for innovation and drug development for many years to come. So, as I reflect on where the company stands today, I would say that much of what we had hoped to accomplish has begun to take shape. Our commercial business is strong. Our pipeline is advancing. Our scientific leadership has never been more apparent. It's exciting. So I'll end my prepared remarks from my last earnings call on a note of great optimism and appreciation for the remarkable opportunity this company has provided me. And with that, I'll turn the call over to Todd for a review of the commercial results.