Biogen FY Conference Summary Company Overview - **Company**: Biogen (NasdaqGS:BIIB) - **Date of Conference**: December 02, 2025 Key Points Company Transformation - Biogen has undergone significant changes under the leadership of CEO Chris Viehbacher, focusing on a "new Biogen" strategy that includes cost-cutting measures and restructuring to achieve $1 billion in gross savings and $800 million in net savings [3][4] Pipeline Development - The company has expanded its focus beyond multiple sclerosis (MS) to include four different franchises, with a robust pipeline of 10 phase 3 or phase 3-ready programs [4][5] - Key upcoming products include: - **Leqembi** for Alzheimer's disease - **BIIB080** for tau - **Litifilimab** for lupus - **LRRK2 asset** for Parkinson's disease [4][5] Alzheimer's Market Opportunity - The potential market for pre-symptomatic Alzheimer's treatment is vast, with estimates suggesting it could be multiples larger than the current indications [10][13] - The company is closely monitoring the outcomes of trials from competitors, such as Lilly, which could influence Biogen's strategy and market positioning [11][12] Commercial Dynamics of Leqembi - Pricing for Leqembi: - **IV Induction**: $23,000 - **IV Maintenance**: $13,000 (50% of induction) - **Subcutaneous (SubQ)**: Approximately $18,000, with a potential for a higher price point due to reduced administration costs [22][24][26] - Blood-based biomarkers are expected to play a significant role in diagnosis and treatment confirmation, with an estimated 350,000 tests anticipated this year [29][30] Zurzuvae Program - **Zurzuvae (Zuranolone)** is a 14-day oral medication for postpartum depression, showing strong quarter-over-quarter growth despite initial challenges in market positioning [31][35] - The launch strategy has pivoted towards OB-GYNs, which has proven effective [34][36] Felzartamab Program - Felzartamab is anticipated to be a significant product in nephrology, with a focus on indications such as Antibody-Mediated Rejection (AMR) and IgA Nephropathy (IgAN) [48][49] - The AMR indication alone has a patient population of approximately 11,000, suggesting a multi-billion dollar market potential [50] Future Considerations - The company is exploring the development of an oral BTK inhibitor with a clean liver profile, which could be a valuable addition to its MS portfolio if safety concerns are addressed [52] Additional Insights - The company is focused on building a strong market access team to navigate pricing and value propositions for its new products [50] - Anecdotal evidence from patients indicates potential improvements in quality of life with current treatments, which may influence physician adoption and patient acceptance [15][19] This summary encapsulates the key discussions and insights from Biogen's FY conference, highlighting the company's strategic direction, product pipeline, and market opportunities.

Summary of Biogen's Conference Call on Felzartamab and Nephrology Developments Company and Industry Overview - **Company**: Biogen - **Industry**: Biopharmaceuticals, specifically focusing on nephrology and autoimmune diseases Key Takeaways from ASN Meeting - The ASN meeting highlighted a significant shift towards innovative therapies in nephrology, emphasizing the potential for cures rather than just managing complications of kidney diseases [3][4] - There is a growing enthusiasm for new therapies that could transform treatment paradigms in nephrology [3] Felzartamab (Felza) Overview - Felzartamab is a targeted therapy developed for severe immune diseases, particularly focusing on conditions like IgA nephropathy and antibody-mediated rejection (AMR) [5][6] - The therapy targets CD38, which is expressed on antibody-producing cells, offering a novel approach in treating autoimmune diseases [9][10] Indications and Clinical Studies - Initial indications for Felza include: - **IgA Nephropathy**: Demonstrated durable treatment effects extending beyond dosing intervals, with significant efficacy observed in early studies [12][14] - **AMR**: A small phase two study showed an 80% resolution rate in microvascular inflammation, indicating transformative efficacy [12][24] - **Primary Membranous Nephropathy (PMN)**: Targeting high-risk patients who are refractory to existing therapies [33] Competitive Landscape and Market Positioning - The treatment landscape for IgA nephropathy is evolving, with multiple therapies expected to enter the market soon, including foundational therapies and targeted therapies [15][16] - Felza is positioned as a disease-modifying therapy that may provide a durable response without the need for continuous dosing, unlike other therapies that require ongoing administration [17][18] Regulatory and Development Strategy - The primary endpoint for the phase three AMR study is the resolution of AMR by histology, with a focus on durability and stabilization of kidney function [29][30] - The anticipated timeline for AMR data is 2027, with a filing expected in 2028, followed by studies for isolated microvascular inflammation and PMN [36][37] Safety and Efficacy Considerations - Long-term safety data is still needed, as current studies have been relatively small and of short duration [18] - The potential for combination therapies and patient preferences will play a crucial role in treatment decisions [18][22] Future Directions and Insights - Ongoing research aims to deepen the understanding of disease mechanisms, particularly the role of NK cells in AMR and the complexities of antibody-mediated diseases [40][41] - Biogen is exploring subcutaneous dosing options for Felza to improve patient access and tolerability [38] Conclusion - Biogen is at the forefront of advancing Felzartamab in nephrology, with promising data and a strategic approach to addressing significant unmet needs in autoimmune kidney diseases [42][43]

Biogen's Strategic Direction - Biogen is broadening its portfolio across Neuro, Immunology & Rare Disease, aiming for long-term sustainable growth[4,17] - Approximately 50% of Biogen's total company revenue is projected to come from outside of MS, including Biosimilars[17] Felzartamab's Potential in Nephrology - Felzartamab targets CD38-expressing cells, offering a differentiated approach for antibody-mediated diseases[27,29] - Phase 3 programs for Felzartamab are underway, targeting Antibody Mediated Rejection (AMR), IgA Nephropathy (IgAN), and Primary Membranous Nephropathy (PMN)[106] Antibody Mediated Rejection (AMR) - Late AMR affects approximately 11,000 patients in the U S, with >75% transplant loss and a median graft survival of ~2 years after diagnosis[36,37,40] - In a Phase 2 study, Felzartamab treatment resulted in >80% biopsy late AMR resolution at week 24, compared to 20% in the placebo group[53] - A Phase 3 study for Felzartamab in late AMR is underway, with data expected in 2027[56] IgA Nephropathy (IgAN) - IgAN affects approximately 130,000 patients in the U S, with up to 40% of patients reaching end-stage kidney disease within 20 years of diagnosis[61] - Phase 2 data showed that with 5 months of Felzartamab treatment, patients had sustained clinical benefit out to 2 years, with ~50% UPCR reduction at 24 months in the 9-dose group[69,71] - A Phase 3 study for Felzartamab in IgAN is designed to demonstrate improvement in kidney function, with data expected in 2029[74] Primary Membranous Nephropathy (PMN) - PMN affects approximately 36,000 patients in the U S, with up to 40% progressing to end-stage kidney disease within 15 years[80,81,103] - Phase 2 data showed robust and sustained reductions in anti-PLA2R and improvements in both newly diagnosed/relapsed (NDR) and refractory PMN patients[103] - A Phase 3 study for Felzartamab in PMN is designed to demonstrate complete remission of proteinuria, with data expected in 2029[100]