Alkermes (ALKS) Jefferies London Healthcare Conference 2024 summary

Business transformation and commercial focus

• Transitioned to a pure-play, profitable neuroscience company with a simplified business model and strong commercial portfolio.

• VIVITROL's revenue outlook is modeled with a gradual decline post-2027 due to a single ANDA filer, expecting a biosimilar-like protracted revenue curve.

• LYBALVI's commercial strategy emphasizes payer agreements that maintain gross-to-net margins, with most major retail payers contracted and volume growth expected to continue steadily.

• Medicare Part D reform impact is mitigated by a small biotech exemption, resulting in minimal exposure phased in over several years.

• Commercial footprint will expand in 2025 to maintain share of voice amid new branded competition in schizophrenia.

Orexin pipeline and clinical development

• Orexin asset ALKS 2680 is the core growth driver, with a promising safety and efficacy profile in narcolepsy types 1 and 2 (NT1, NT2) and idiopathic hypersomnia (IH).

• Phase II trials use fixed-dose periods followed by real-world dose selection, providing robust data for phase III and commercial planning.

• No need for titration protocol in phase III anticipated, as modal doses will be identified from phase II data.

• High selectivity for OX2 receptor (10,000–5,000 fold) supports a favorable side effect profile, with urinary effects attributed to upregulated nervous system activity rather than OX1 activation.

• Durability and flexibility in dosing are expected to address broader populations beyond NT1, with phase II data to confirm efficacy in NT2 and IH.

Competitive landscape and strategic outlook

• Orexin field is led by three main players: Takeda, Alkermes, and Centessa, with recent exits or pauses from other large pharma.

• Alkermes is the only company with clinical data across NT1, NT2, and IH, differentiating its asset from competitors.

• ADHD and cognition are being explored as future indications, leveraging orexin's role in wakefulness and attention circuits.

• Management is not seeking immediate partnerships; expansion into additional indications and compounds is ongoing, with flexibility to scale development as opportunities grow.

• Long-term vision draws analogy to GLP-1 expansion, starting with narcolepsy and potentially broadening to larger primary care indications.