Alkermes (ALKS) investor relations material

Recent progress and strategic developments

• Significant changes over the past year include validation of the orexin agonist class, the acquisition of Avadel, and a planned CEO transition.

• The orexin agonist program is advancing, with phase III trials underway after robust phase II results demonstrating safety, efficacy, and tolerability across multiple doses.

• The commercial business generates $1.7 billion in revenue, providing strong cash flow to fund innovation and strategic flexibility.

• Integration of Avadel and its LUMRYZ asset strengthens the commercial platform and prepares for future launches.

• The CEO transition is set for August, with a focus on continuity and maintaining a patient-centered culture.

Orexin agonist program and clinical differentiation

• The orexin agonist is positioned as best-in-class, offering multiple dosing regimens and broad indication coverage for hypersomnolence disorders.

• Phase II and III data show clinically meaningful improvements in wakefulness, fatigue, and cognition, with durable effects and normalization of patient-reported outcomes.

• Differentiation is based on dose flexibility, regimen options, and applicability across NT1, NT2, and idiopathic hypersomnia.

• The program aims for a label that is difficult for competitors to match, leveraging comprehensive efficacy and patient-centric endpoints.

• Ongoing studies include split-dose regimens and expanded endpoints such as cognition and fatigue.

Clinical trial execution and enrollment

• Phase III Brilliance program includes two NT1 studies and one NT2 study, with strong patient and physician interest and active enrollment in the US and Europe.

• Prior phase II experience has streamlined phase III execution, with robust site engagement and data collection.

• Takeda’s market entry is not expected to hinder enrollment; instead, it may help educate the market and drive awareness.

• Power calculations are less critical due to large effect sizes; focus is on clinical effect and data standardization.

• Enhanced standardization in cataplexy measurement and training aims to improve data fidelity in phase III.