Alkermes (ALKS) investor relations material

Strategic outlook and market positioning

• Anticipates a pivotal year with the orexin program reaching full potential, especially as Takeda's drug approval is expected to set pricing and launch benchmarks for the class.

• Emphasizes competitive differentiation through dosing flexibility and broad applicability across NT1, NT2, and IH, with options for once-daily and split dosing to match patient needs.

• Expects the orexin agonist to offer more features and benefits than competitors, aiming to address both physiological and lifestyle requirements.

• Predicts orexin agonists will become the dominant therapy for NT1, while a subset of patients will continue to value nighttime sleep consolidation from oxybates.

• Notes that market expansion is likely as improved oral medications and easier diagnostics increase diagnosis rates.

Clinical insights and data interpretation

• NT2 and IH populations show overlapping characteristics, with efficacy of orexin agonists remaining strong despite baseline variability.

• Clinical trials reveal that efficacy, as measured by MWT, plateaus after four weeks without further degradation, supporting long-term durability.

• Split dosing is being integrated into pivotal programs to address variability in patient response and extend efficacy throughout the day.

• Fatigue and cognition endpoints are gaining importance, as they better capture patient experience beyond traditional sleepiness measures.

• Ongoing studies in IH and ADHD are expected to provide further quantitative and translational data this year.

Pipeline expansion and future plans

• Plans rapid advancement in ADHD, launching a large phase II study this year, supported by promising translational and preclinical data.

• Fatigue in MS and Parkinson’s is a key area of interest, with initial studies leveraging validated endpoints and ongoing FDA engagement.

• Expects to pioneer regulatory pathways for fatigue indications, using narcolepsy data and fatigue scales to support registration.

• IH indication is seen as highly value-adding, with clinical trial design mirroring previous successful approvals.

• LUMRYZ, a once-nightly oxybate, is positioned as a viable alternative to twice-nightly products, targeting patients prioritizing sleep consolidation.