Biogen (NasdaqGS:BIIB) FY Conference Transcript

Biogen FY Conference Summary Company Overview - Company: Biogen (NasdaqGS:BIIB) - Date of Conference: September 24, 2025 Key Points Alzheimer's Disease and LEQEMBI - Biogen is experiencing positive momentum with the launch of LEQEMBI, particularly following the approval for subcutaneous maintenance therapy, which offers patients the option to self-administer at home [2][10] - The company is also pursuing a rolling submission for subcutaneous initiation therapy, expected to provide patients with more treatment options [2][10] - The approval of blood-based biomarkers by the FDA is seen as a significant advancement, increasing testing and potentially improving patient outcomes [3] Revenue Growth and R&D Focus - Year-on-year revenue growth from new products is offsetting declines from multiple sclerosis (MS) products, indicating a strategic shift towards growth products [4] - Biogen is focusing on high-value, high-probability success programs in its R&D pipeline, with several late-stage programs expected to yield registrational data soon [4][5] Pipeline Developments - Biogen is advancing several programs into Phase 3 trials, including treatments for lupus and rare nephrology conditions [5][6] - The company is also exploring new modalities and collaborations, such as with Stoke Therapeutics for Dravet syndrome [6][7] TAU ASO and CELIA Study - The TAU ASO (BIIB080) is in Phase 2 trials, with hopes to demonstrate significant reductions in TAU levels and clinical benefits [11][12] - The CELIA study aims to evaluate the impact of reducing all TAU isoforms on biomarkers and clinical outcomes [12] GLP-1 and Alzheimer's - Biogen acknowledges the potential of GLP-1 therapies in addressing neuroinflammatory pathways in Alzheimer's, despite mixed results from other trials [15] AHEAD Trials - The AHEAD 3 and AHEAD 4, 5 trials are designed to address pre-symptomatic stages of Alzheimer's, focusing on preventing further amyloid accumulation and cognitive decline [17][18] SMA and SPINRAZA - Biogen continues to focus on spinal muscular atrophy (SMA) with SPINRAZA, which remains a critical therapy despite competition from gene therapies [22][23] - The company is pursuing a high-dose version of SPINRAZA and a new antisense oligonucleotide, Salinursin, with promising early data [24][25] Lupus Opportunities - Lupus is identified as a significant market opportunity, with only two biologics currently available and a high unmet need [27][28] - Biogen is advancing Dapirolizumab pegol and litifilimab through multiple Phase 3 trials, targeting different lupus manifestations [29][30] Felsardimab and Rare Kidney Indications - Felsardimab is being explored for several rare kidney conditions, with ongoing Phase 3 trials and a focus on addressing unmet needs in these areas [39][40] - The company is optimistic about the potential of Felsardimab in conditions like AMR and IgAN, despite a crowded competitive landscape [41][42] IRAK4 Program - The IRAK4 program is in early development stages, with plans for a Phase 2 program to explore its potential in various inflammatory conditions [48] Overall R&D Strategy - Biogen's R&D strategy emphasizes a diversified pipeline with multiple high-value programs, aiming for significant market impact across various therapeutic areas [50] - The company is committed to innovation and disciplined cost management while expanding its portfolio through both internal and external collaborations [50] Conclusion - Biogen is positioned for growth with a robust pipeline across neurology, immunology, and rare diseases, focusing on high unmet needs and innovative therapies [50]