Alkermes plc Q3 FY2025 earnings call

• Commercial: Strong execution in Q3 with net sales from proprietary portfolio at $317.4M. VIVITROL performance driven by alcohol dependence market growth. Expansion of psychiatry sales force increased call volume for LYBALVI and ARISTADA. Full-year guidance for VIVITROL, ARISTADA, and LYBALVI revised upward.
• R&D: Orexin 2 receptor agonist pipeline advancing rapidly. Alixorexton showed compelling results in Phase II for narcolepsy type 1. Vibrance-2 in narcolepsy type 2 expected to report data in November, Vibrance-3 in idiopathic hypersomnia enrolling well. ALKS 4510 and ALKS 7290 in clinic.
• Acquisition of Avadel: Gains FDA-approved LUMRYZ with growth potential ($265-$275M net revenue expected in 2025), accelerates sleep medicine entry, and enhances development strategy in sleep disorders.

In the third quarter, Alkermes' proprietary product portfolio generated net sales of $317.4 million, reflecting 16% year-over-year growth. VIVITROL had Q3 net sales of $121.1 million, with full-year 2025 expected to be in the range of $460 million to $470 million. ARISTADA had Q3 net sales of $98.1 million, with full-year 2025 expected to be $360 million to $370 million. LYBALVI had Q3 net sales of $98.2 million, with full-year 2025 expected to be $340 million to $350 million. Manufacturing and royalty revenues were $76.8 million for the third quarter, including $35.6 million from VUMERITY and $30.2 million from long-acting INVEGA products. Revenue contribution percentages aren't explicitly stated for each segment but the proprietary products are the main drivers.

• Raised 2025 full-year guidance to total revenues of $1.43 billion to $1.49 billion, GAAP net income of $230 million to $250 million, EBITDA of $270 million to $290 million, and adjusted EBITDA of $365 million to $385 million.
• Expect Q4 net sales from proprietary portfolio in the range of $300 million to $320 million.

• Regulatory risks where actual results could differ from forward-looking statements.
• Impact of pharmaceutical pricing discussions globally.
• Variability in patient populations and study results affecting the interpretation of data for product development and approval.

Q: Talk about LYBALVI's performance, gross-to-net, and expectations into next year.

A: Todd Nichols stated LYBALVI had strong Q3 performance with 25% year-over-year TRx growth and nearly 16% year-over-year new patient start NBRx increase. Gross-to-net was lower in Q3 due to deductible resets and lower co-pay utilization, but momentum expected to carry into Q4 with no guidance provided for next year's gross-to-net.

Q: Thoughts on NT2 study, MWT benefit, and blinded safety for NT2?

A: Rich Pops said they'll look at the full NT2 data set in a few weeks, expecting to request an end of Phase II meeting with FDA once NT2 data is in hand. Umer Raffat's question about MWT benefit and blinded safety was addressed by Rich Pops stating they'll evaluate the full data set in aggregate from the large multi-week randomized, placebo-controlled study.

Q: On NT2 study, MWT benefit expectations and PK profile of next-gen orexin agonist?

A: Rich Pops said they don't expect significant evidence of tachyphylaxis or efficacy degradation between time points at the top line, but will see dose response in Vibrance-2. On PK profile of next-gen orexin agonists, details weren't disclosed as they're designed for different patient populations and settings but share common features of potency and selectivity.

Q: Importance of ESS in NT2 study and ocular monitoring in Phase III?

A: Richard F. Pops said both MWT and ESS are primary endpoints in NT2 study, capturing different aspects. On ocular monitoring in Phase III, it's too early to say, but Vibrance-1 showed very mild ocular AEs with rigorous exams.

Q: Thoughts on additional orexins in psychiatric settings and alixorexton ex U.S.?

A: Richard F. Pops said next candidates are interested in psychiatry, neurology, and rare neurodevelopmental/neurodegenerative settings. Alixorexton is being developed ex U.S. with plans to bring to patients globally without significantly lower prices than in the U.S.

Q: NT2 vs IH populations and capturing them in trials?

A: Richard F. Pops said it's de novo clinical research with no pretest hypothesis on differences, and the studies will reveal distribution and variability in patient populations.

Q: Timeline for next-gen orexins' Phase I data and low-salt oxybate?

A: Richard F. Pops said timing of Phase I data for 4510 and 7290 is pending, and plans for low-salt oxybate will be detailed post-acquisition.

Q: Impact on nighttime sleep and ARISTADA's gross-to-net?

A: Richard F. Pops discussed potential clinical research on orexin vs oxybate's impact on nighttime sleep. Todd Nichols said ARISTADA's full-year gross-to-net is expected to be approximately 53% following historical patterns.

Q: Gross-to-net favorability and inventory?

A: Todd Nichols said there's no additional gross-to-net favorability planned for Medicaid going forward, and inventory has seasonal patterns with a smoother outlook from Q4 2025 to Q1 2026.

Q: Phase III scenarios for alixorexton?

A: Richard F. Pops said assumption is 2 Phase IIIs, seeking labeling for narcolepsy with stand-alone studies for NT1 and NT2.

Q: Impact of ACA subsidies and LYBALVI's success drivers?

A: Richard F. Pops discussed political importance of ACA subsidies for Medicaid populations. Todd Nichols said LYBALVI's success is due to strong efficacy, broad label, commercial execution, and resourcing, with growth in bipolar and schizophrenia populations.

Q: Drivers of LYBALVI's performance and visual AEs in Vibrance-1?

A: Todd Nichols said LYBALVI's success is driven by efficacy, broad label, commercial investment, and HCP experience. Richard F. Pops discussed visual AEs in Vibrance-1 as mostly mild, with one moderate and one severe case, largely transient and dose-responsive.