Alkermes (ALKS) investor relations material

Strategic vision and growth outlook

• Focused on profitable growth in neuroscience, leveraging a strong commercial foundation, late-stage orexin innovation, and a diversified portfolio in addiction, psychiatry, and sleep medicine.

• Generated over $1.45 billion in revenues in 2025, with strong cash flow and profitability, further enhanced by the planned acquisition of Avadel/Avidel.

• The acquisition of Avadel/Avidel and its narcolepsy drug LUMRYZ/Lumryz accelerates entry into the sleep medicine market and is expected to be accretive in 2026.

• The company expects to finance the Avadel/Avidel transaction with cash and new debt, not equity, and anticipates closing in the current quarter/Q1 2026.

• Orexin 2 receptor agonist candidates are positioned as a new vertical for expansion into multiple disease areas beyond sleep medicine.

Pipeline and clinical development

• ALKS 2680/Alixorexton, an orexin 2 receptor agonist, is entering Phase 3 for narcolepsy after positive Phase 2 results and FDA Breakthrough Therapy designation for NT1.

• Vibrance Phase 2 studies in narcolepsy types 1 and 2 showed significant efficacy and safety, with high patient rollover into extension studies.

• Brilliance Phase 3 program in narcolepsy will include both once-daily and split-dose regimens, with endpoints focused on sleepiness, cataplexy, fatigue, and cognition.

• The IH Phase 2 study is ongoing, with completion expected in Q4/Q4 2026, and Phase 3 initiation planned after an end-of-Phase 2 FDA meeting.

• Additional orexin 2 receptor agonist candidates (ALKS 7290, ALKS 4510) are advancing in ADHD and fatigue associated with neurodegenerative diseases, with Phase 2 studies planned for 2024/2026.

Market opportunity and competitive positioning

• The narcolepsy and idiopathic hypersomnia market is valued at over $10 billion annually, with significant unmet need and limited competition due to complex chemistry and strong patent protection.

• Orexin 2 receptor agonist class represents a multi-billion dollar opportunity in sleep medicine, with potential to evolve the standard of care.

• LUMRYZ/Lumryz, with patent protection into 2042 and orphan drug exclusivity, strengthens the sleep medicine portfolio; phase 3 data in idiopathic hypersomnia expected Q2 2026.

• ALKS 2680/Alixorexton is differentiated by its broad dose range, potential for both NT1 and NT2 indications, and flexible dosing regimens, aiming for a competitive edge.

• The Orexin platform is being developed for broader indications, including psychiatric, neurological, and cardiometabolic disorders.