Biogen Conference Call Summary Company Overview - **Company**: Biogen (NasdaqGS:BIIB) - **Date**: November 13, 2025 - **Event**: TD Cowen's 2025 I&I Summit Key Industry and Company Insights Immunology and Kidney Strategy - Biogen has reinvigorated its immunology and kidney efforts, leveraging its expertise in neuroimmunology from its historical focus on neuroscience [2][3] - The strategy aims to support a diverse product portfolio by targeting immunological pathways applicable to multiple disease indications [2][3] R&D Pipeline Structure - The ideal R&D pipeline in immunology is driven by scientific understanding, allowing for efficient early development trials and multi-indication strategies [4][5] - Biogen's approach includes starting with multiple indications simultaneously to build confidence for further expansion [5] Investor Perception - Investors currently undervalue Biogen's immunology and kidney pipeline, potentially missing the strategic rationale behind the development of drugs like felzartamab [6] - Felzartamab is positioned to address antibody-mediated rejection in kidney transplants, supported by robust clinical data [6][7] Lupus Pipeline Confidence - Biogen has two late-stage candidates for lupus: dapirolizumab pegol and litifilimab, with confidence stemming from data-driven insights and successful proof of concept studies [9][10] - The company emphasizes the importance of clinical trial execution and understanding disease management in lupus, which has historically been challenging [10][11] Ongoing Trials - The Topaz 1 and 2 trials for systemic lupus erythematosus (SLE) have completed enrollment, with data expected by the end of 2026 [14][15] - These trials are designed to test different dosing paradigms and measure various endpoints related to disease control [15][16] Key Risks and Considerations - Risks to trial success include the complexity of lupus management and the need for precise clinical trial execution [17][18] - Biogen aims to meet statistical significance and meaningful patient outcomes in its trials, focusing on reducing flares and steroid use [19][20] New Programs and Future Directions - Biogen recently introduced BIIB142, an IRAK4 degrader, which is an oral molecule with potential applications across various autoimmune diseases [32][33] - The company is exploring multi-indication strategies for this new asset and continues to build its early-stage pipeline through collaborations and acquisitions [36] Additional Insights - Biogen is committed to reducing steroid dependency in lupus patients, aligning with evolving treatment guidelines [20] - The company is optimistic about the potential of its lupus candidates to provide meaningful improvements in patient quality of life [10][11] This summary encapsulates the key points discussed during the conference call, highlighting Biogen's strategic focus on immunology and kidney disease, ongoing clinical trials, and future directions in research and development.

Financial Data and Key Metrics Changes - The company reported a 3% revenue growth in Q3 2025 compared to Q3 2024, driven by strong commercial execution [47] - Launch products generated $257 million in revenue, representing a 67% year-over-year growth [47] - Non-GAAP diluted EPS grew by 18% for the quarter [50] Business Line Data and Key Metrics Changes - The MS business showed resilient performance, positively impacted by gross-to-net adjustments and strong demand for VUMERITY, despite generic erosion of TECFIDERA in Europe [48][52] - LEKEMBY achieved global revenues growing 82% compared to Q3 2024, with a prescriber base growth of 14% quarter-over-quarter [38] - Skyclaris saw a 30% year-over-year revenue growth, now available in 34 countries [42] - ZERZUVEY experienced a 19% revenue growth compared to the previous quarter, with 80% of prescriptions written as first-line therapy [45] Market Data and Key Metrics Changes - The anti-amyloid market grew approximately 15% this quarter, indicating a positive trend in the market dynamics [41] - Blood-based biomarker testing is expected to reach up to 350,000 tests this year, a 75% increase compared to the previous year [41] Company Strategy and Development Direction - The company is focused on expanding its early-stage pipeline while maintaining a robust late-stage pipeline with 10 Phase III or Phase III-ready programs [18][28] - Strategic acquisitions, such as Alcion Therapeutics, are aimed at enhancing the company's capabilities in treating various diseases [15] - The company aims to deliver $1 billion in gross savings and $800 million in net savings under the Fit for Growth initiative by 2025 [62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong business trends observed in Q3, leading to an improved revenue outlook [50] - The company anticipates increased competitive pressures on the ex-U.S. MS business, particularly for TECFIDERA in Europe [61] - Management remains optimistic about the potential of LEKEMBY in the presymptomatic Alzheimer's disease population [35] Other Important Information - The company generated approximately $1.2 billion of free cash flow in the quarter, exiting with $4 billion in cash and marketable securities [58] - The company is actively working on securing reimbursement in European markets for Skyclaris and expanding its geographic reach [55] Q&A Session Summary Question: Impact of EVOQUE trial on Lykkembe franchise - Management indicated that the results of the EVOQUE trial will determine the impact on the Lykkembe franchise and the need for a broader portfolio [66][68] Question: Growth potential in immunology - Management highlighted the company's historical presence in immunology and the potential for growth in rare immunology and overlapping areas with existing experience [72][74] Question: Confidence in late-stage pipeline - Management expressed confidence in the late-stage pipeline, citing compelling Phase II data and a thoughtful progression in derisking the pipeline [79][81] Question: Early experience with LAKEMBY subcutaneous maintenance - Management reported positive feedback from payers and healthcare providers regarding the subcutaneous maintenance option, anticipating gradual uptake [88][90] Question: Commercial implications of prevention studies - Management acknowledged the potential commercial implications of positive trial results but emphasized the need for improved capacity and referral quality in the healthcare system [96][98]