Alkermes (ALKS) investor relations material

Business and pipeline outlook

• Acquired Avadel; reported positive Phase III LUMRYZ data in idiopathic hypersomnia (IH), advanced orexin programs into Phase III, and announced promising ADHD data for ALKS 7290.

• Six medium- or late-stage programs are expected to report over the next 12 months across narcolepsy, ADHD and fatigue; LUMRYZ IH application filing is planned.

• Generated over $1.8 billion in revenue this year and described the business as highly profitable; near-term priority is execution and high-quality data.

Orexin and sleep disorders

• In NT2, alixorexton showed strong responses on ESS and MWT across multiple doses; IH is viewed as similar, with long sleepers—about 25% of IH patients—a key subgroup to assess.

• A 4-point ESS change is typically clinically meaningful and 6 points moderate; at the highest NT2 dose, about 70% normalized from moderate-to-severe to normal.

• IH Phase II is designed with power similar to NT2; results will inform Phase III, including any distinct response among long sleepers.

• NT1 and NT2 Phase III enrollment is progressing well, with completion expected around mid-summer next year; efficacy is expected to be similar to Phase I/II, with limited signal erosion from study scale or sites.

• In hypersomnolence, efficacy and flexible dosing are key; potential options include high-dose, once-daily and split dosing. Takeda's launch is expected to expand awareness, with an estimated 100,000 patients having tried oxybates without adequate benefit.

ADHD and other indications

• The ALKS 7290 Phase Ib ADHD study was an inpatient, two-week, non-placebo-controlled study; consistent responses across patient- and physician-reported measures, a 2-point CGI-S change and EEG findings supported proof of mechanism and dose selection.

• The ongoing randomized, placebo-controlled Phase II dose-ranging study is intended to determine effect size; readout is expected in H2 next year.

• Preferred ADHD profile is stimulant-like efficacy with a cleaner safety profile and broader response, potentially including cognition; early data put ALKS 7290 in a wide therapeutic window for ADHD and depression.

• Phase II fatigue studies in MS and Parkinson's are testing PROMIS and disease-specific scales to identify suitable endpoints before agency discussions and decisions on a regulatory path.

• MDD Phase II will study a general population and a group with excessive sleepiness; the latter is estimated at about 50% of MDD patients and may enrich the program.