Biogen (BIIB) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Strategic priorities and financial outlook

• Focused on four new product launches: LEQEMBI (Alzheimer's), SKYCLARYS (Friedreich's ataxia), ZURZUVAE (postpartum depression), and QALSODY (ALS), all progressing as expected or better.

• Committed to sustainable growth, supported by the Fit for Growth program targeting $1 billion in cost savings by 2025, with $800 million net savings after reinvestment.

• Achieved 1% top-line growth and 6% core pharmaceutical revenue growth in Q2 at constant currency, with new launches offsetting declines in mature MS products.

• Recent business development includes acquisitions of Reata and HI-Bio, maintaining a strong balance sheet and $8–$10 billion in capital deployment capacity over the next few years.

• 2025 earnings guidance will be provided after Q4 2024; MS franchise decline and new launches will dictate top-line trajectory, with $400 million in cost savings expected in both 2024 and 2025.

Research and development focus

• Completed reprioritization and termination of non-strategic programs; now investing in Alzheimer's, pediatric development for SKYCLARYS, and expanding the pipeline.

• Accelerated proof-of-concept for BIIB080 (anti-tau therapy) and progressing litifilimab and dapi in phase III, with additional focus on felzartamab (anti-CD38 antibody) based on strong biomarker and clinical data.

• Consistent internal and external criteria applied to build a pipeline in neurology, rare, and immunology for sustained growth.

• R&D targets early, mid, and late-stage programs, emphasizing de-risking through data and clear diligence, as seen with HI-Bio.

Product launches and market dynamics

• LEQEMBI launch progressing, with $40 million in Q2 revenue and a 50% increase in prescribing physicians; majority of prescribers are neurologists, with plans to expand to primary care.

• Subcutaneous and IV maintenance formulations for LEQEMBI in regulatory review, with key milestones expected: IV maintenance PDUFA in Jan 2025, subcutaneous maintenance outcome by mid-2025, and induction by Q1 2026.

• LEQEMBI differentiated from new competitor Kisunla by dual action, longer-term data, and lower ARIA rates; both products expected to expand the Alzheimer's market.

• Real-world and clinical data support optimism for LEQEMBI's CHMP reexamination in Europe, with a decision expected by end of 2024.

• Ex-U.S. expansion includes approvals in Japan, China, and South Korea, with Europe pending.