Biogen (BIIB) Jefferies Global Healthcare Conference summary

LEQEMBI launch and market dynamics

• Patient uptake for LEQEMBI increased 2.5x from Q4 to Q1, with 70% of patients coming from smaller centers and 30% from top integrated delivery networks.

• The main bottleneck is access to specialists, not reimbursement or PET scans; demand remains strong.

• International approvals have expanded to Japan, China, and South Korea, with 13 more locations under review.

• Growth is expected to remain steady and gradual, with potential acceleration from future blood-based diagnostics.

• No significant patient discontinuations due to lack of utility; KPIs are trending positively.

Subcutaneous (sub-Q) formulation and regulatory outlook

• Maintenance sub-Q filing is under rolling review, with fast track designation; full submission expected by end of Q3, and FDA decision likely in 2025.

• Patients could transition to weekly sub-Q auto-injector after 18–24 months of IV induction; device delivers 360mg in a few seconds.

• Induction sub-Q filing expected in 2025, with FDA decision anticipated in Q1 2026; dose optimization ongoing.

• Sub-Q options are expected to improve patient and prescriber convenience and may support broader adoption over the next three years.

European regulatory process and competitive landscape

• European approval is delayed due to reorganization of Scientific Advisory Groups (SAGs) over conflict of interest concerns; new SAG expected to be scheduled imminently.

• Regulatory decision in Europe is anticipated by Q3.

• A competitor’s product may soon be approved in the U.S.; management believes this could expand the market and accelerate infrastructure development.