Core Insights - Biogen has acquired global rights to Vanqua Bio's experimental drug for a total consideration of up to $1.06 billion, aimed at enhancing its immunology drug pipeline [1] Company Summary - The acquisition reflects Biogen's strategic move to expand its portfolio in the immunology sector, indicating a focus on innovative treatments [1] - The financial commitment of up to $1.06 billion suggests a significant investment in research and development for new therapeutic options [1]

Core Insights - Biogen has entered into a license agreement with Vanqua Bio for exclusive worldwide rights to a preclinical oral C5aR1 antagonist, aimed at addressing various inflammatory disorders with high unmet needs [1][2][3] Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on innovative science to develop new medicines and create value for shareholders and communities [4] - Vanqua Bio, established in 2019, specializes in discovering and developing next-generation medicines for neurodegenerative and inflammatory diseases [6] Agreement Details - The agreement includes a $70 million upfront payment to Vanqua Bio and potential additional payments up to $990 million based on development, regulatory, commercial, and sales milestones, along with tiered royalties on net sales [3] - Biogen plans to record the upfront payment as an Acquired In-Process Research and Development expense in Q4 2025 [3] Strategic Focus - The C5aR1 antagonist is expected to enhance Biogen's immunology pipeline by providing an oral mechanism applicable across multiple immune-mediated diseases [2] - The C5aR1 target is validated for its role in neutrophil-mediated inflammation, which is significant in various inflammatory disorders [2]

Core Insights - Biogen Inc. announced upcoming presentations on dapirolizumab pegol (DZP), an anti-CD40L drug candidate for systemic lupus erythematosus (SLE), at the ACR Convergence 2025 [1][2] - The presentations will cover efficacy results across multiple endpoints, including disease activity, flares, fatigue, joint pain, and quality of life, along with preclinical data on placental transfer [1][4] Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on innovative science to develop new medicines and create shareholder value [7] - The company emphasizes a deep understanding of human biology and aims to deliver first-in-class treatments [7] Product Development - Dapirolizumab pegol is in Phase 3 clinical development for SLE, developed in collaboration with UCB [6][2] - It is one of only three biologics to report positive Phase 3 data in a global SLE study, with the primary endpoint met after 48 weeks [2][4] - Ongoing studies include the PHOENYCS FLY trial, which continues to evaluate the drug's efficacy [2][6] Presentation Details - Presentations at ACR will include various poster sessions focusing on quality of life improvements, adverse outcomes in reprotoxicity studies, and fatigue and pain management in SLE patients [3][5] - Specific poster presentations are scheduled for October 26-28, 2025, detailing results from Phase 3 trials [3][5]

Core Insights - J. L. Bainbridge & Co. sold 119,376 shares of Biogen for approximately $16.1 million during the third quarter, significantly reducing its holdings to just 2,969 shares valued at $415,898 as of September 30 [2][7] Company Overview - Biogen specializes in therapies for complex neurological and neurodegenerative conditions, with a diversified product suite and a robust pipeline [6][10] - As of the latest market close, Biogen's stock price was $143, with a market capitalization of $21 billion, revenue of $10 billion, and net income of $1.5 billion for the trailing twelve months [4] Financial Performance - Biogen's shares have declined by 23% over the past year, despite a strong second-quarter report showing a 7% year-over-year revenue growth to $2.6 billion and raised full-year guidance [3][8] - The company highlighted growth in its Alzheimer's therapy LEQEMBI, rare-disease drug SKYCLARYS, and postpartum-depression treatment ZURZUVAE, indicating strong execution in reshaping its portfolio for sustainable growth [11] Investment Strategy - J. L. Bainbridge's decision to significantly reduce its Biogen holdings aligns with its strategy to concentrate on proven large-cap growth names like Microsoft, Apple, and Alphabet [12] - The upcoming earnings report on October 30 will be crucial for assessing whether Biogen's new drug launches can offset the decline in its older franchises [12]

[FORM 8-K Filing Information](index=1&type=section&id=FORM%208-K%20Filing%20Information) Details Biogen Inc.'s registrant information, common stock registration, and the report's filing date [Registrant Information](index=1&type=section&id=Registrant%20Information) This section identifies Biogen Inc. as the registrant, detailing its incorporation state, commission file number, IRS employer ID, principal executive offices, and telephone number - Registrant: **Biogen Inc.**, incorporated in Delaware[2](index=2&type=chunk) - Date of Report: **October 14, 2025**[2](index=2&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) The company's common stock is registered on The Nasdaq Global Select Market under the trading symbol BIIB Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.0005 par value | BIIB | The Nasdaq Global Select Market | - Biogen Inc. is not an emerging growth company[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Presents preliminary Q3 2025 financial estimates, R&D expense definitions, and forward-looking statement disclosures [Estimated Financial Impact for Q3 2025](index=2&type=section&id=Estimated%20Financial%20Impact%20for%20Q3%202025) Biogen Inc. anticipates an approximate $2 million pre-tax charge for acquired in-process research and development, upfront and milestone expense in Q3 2025, which is expected to reduce GAAP and non-GAAP net income per diluted share by approximately $0.01 Estimated Q3 2025 Financial Impact | Metric | Estimated Impact (USD) | | :------------------------------------------------------------------ | :--------------------- | | Acquired in-process R&D, upfront and milestone expense (pre-tax) | ~$2 million | | Impact on GAAP and non-GAAP net income per diluted share | ~($0.01) per share | [Definition and Presentation of Acquired In-Process R&D Expense](index=2&type=section&id=Definition%20and%20Presentation%20of%20Acquired%20In-Process%20R%26D%20Expense) Starting Q1 2025, Biogen began presenting acquired in-process research and development, upfront and milestone expense as a separate line item, which the company does not forecast due to uncertainty - Acquired in-process R&D, upfront, and milestone expense began separate line item presentation in **Q1 2025**[6](index=6&type=chunk) - Expense encompasses costs from collaboration and license agreements, including upfront/milestone payments and premiums on equity securities/asset acquisitions of acquired in-process R&D[6](index=6&type=chunk) - Biogen does not forecast these expenses due to their uncertain future occurrence, magnitude, and timing[6](index=6&type=chunk) [Preliminary Nature of Results](index=2&type=section&id=Preliminary%20Nature%20of%20Results) The financial results for the quarter ended September 30, 2025, are preliminary and subject to finalization, with no assurance that final results will not differ from these unaudited estimates - Q3 2025 results are preliminary and subject to financial statement closing procedures[7](index=7&type=chunk) - Final results may differ from preliminary unaudited estimates[7](index=7&type=chunk) [Note Regarding Forward-Looking Statements](index=2&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) This report contains forward-looking statements, made under the Private Securities Litigation Reform Act of 1995, which involve substantial risks and uncertainties, and are not publicly updated - Forward-looking statements are subject to substantial risks and uncertainties, potentially causing actual results to differ materially[8](index=8&type=chunk)[9](index=9&type=chunk) - Statements are based on management's current beliefs, assumptions, and available information[9](index=9&type=chunk) - Investors are cautioned against undue reliance; the company does not undertake to publicly update these statements[10](index=10&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) Lists the exhibits furnished with the Form 8-K, including the interactive data file [Exhibits](index=2&type=section&id=Exhibits) This section lists the exhibits furnished as part of the Current Report on Form 8-K, specifically Exhibit 104, which is the Cover Page Interactive Data File Exhibits Furnished | Exhibit No. | Description | | :---------- | :------------------------------------------------ | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=Signatures) Confirms the official signing of the report by Biogen Inc.'s Secretary on October 14, 2025 [Report Signature](index=3&type=section&id=Report%20Signature) The report was duly signed on behalf of Biogen Inc. by Wendell Taylor, Secretary, on October 14, 2025, in accordance with the requirements of the Securities Exchange Act of 1934 - Report signed by **Wendell Taylor**, Secretary, on behalf of Biogen Inc[15](index=15&type=chunk) - Date of signature: **October 14, 2025**[15](index=15&type=chunk)

Core Viewpoint - The economic burden on patients with rare diseases is significant, and addressing this issue requires a multi-layered social mechanism rather than solely relying on individual patients [1][2]. Group 1: Rare Disease Treatment and Insurance - Biogen's Asia-Pacific President emphasizes the need for a collective approach to cover treatment costs for rare diseases, advocating for public awareness of risk-sharing and the importance of commercial insurance [1][2]. - The inclusion of diseases like ALS in insurance coverage is crucial, as 90% of ALS cases are sporadic, highlighting the need for broader public understanding and insurance participation [2]. - The role of commercial insurance is to mitigate large medical expenses, and its coverage should extend beyond just the listed drugs to effectively support patients [2]. Group 2: Biogen's Strategic Direction - Biogen is open to potential mergers and acquisitions in the Asia-Pacific region, focusing on internal innovation while also collaborating with Chinese innovative pharmaceutical companies [3]. - The company has already launched several groundbreaking treatments in China, including the first drug for spinal muscular atrophy (SMA) and a targeted drug for Alzheimer's disease [3]. - Biogen aims to achieve clinical cures for SMA and is advancing another drug in clinical trials that could significantly improve treatment outcomes [3].

Core Insights - LEQEMBI IQLIK™, a subcutaneous autoinjector formulation of lecanemab for Alzheimer's disease treatment, has been recognized by TIME as one of the "Best Inventions of 2025" in the Medical and Healthcare category [1][2] Product Overview - LEQEMBI IQLIK is the first anti-amyloid treatment allowing at-home injections, enabling patients to continue treatment after an initial 18-month period [3] - The treatment was approved in the U.S. in August 2025 and launched on October 6, 2025 [3] - It offers a quick administration time of approximately 15 seconds, reducing the need for infusion center visits and associated healthcare resources [3] Clinical Background - LEQEMBI is the first approved anti-amyloid treatment shown to slow cognitive and functional decline in early Alzheimer's disease [4] - It has been approved in 50 countries and is under regulatory review in 10 additional countries [4][28] - The treatment's efficacy was demonstrated in the Clarity AD clinical trial, where it reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [29] Safety and Efficacy - The safety profile of LEQEMBI IQLIK is similar to that of the intravenous formulation, with a lower incidence of systemic reactions [31] - Common adverse reactions include infusion-related reactions (26% with LEQEMBI vs. 7% with placebo), ARIA-H (14% vs. 8%), and ARIA-E (13% vs. 2%) [25] - The incidence of amyloid-related imaging abnormalities (ARIA) was observed at 21% for LEQEMBI compared to 9% for placebo [11] Collaboration and Development - Eisai leads the global development and regulatory submissions for LEQEMBI, with Biogen co-commercializing and co-promoting the product [5][33] - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development of Alzheimer's treatments [34]

Core Insights - Biogen's key multiple sclerosis (MS) drugs, including Tecfidera and Tysabri, along with the spinal muscular atrophy (SMA) treatment Spinraza, are experiencing declining sales due to increased competition, impacting overall revenue growth [1][3][10] Sales Performance - Sales of Tecfidera are declining due to the launch of multiple generic versions in North America, Brazil, and certain European countries [3] - Tysabri's sales are also declining as a result of heightened competition in the U.S. and the introduction of biosimilars in Europe, with a U.S. biosimilar expected by Q4 2025 [3][4] - Spinraza's revenues are anticipated to be lower in the second half of the year due to unfavorable shipment timing and competition from Novartis' Zolgensma and Roche's Evrysdi [5] New Drug Developments - Biogen's collaboration with Eisai on Leqembi for Alzheimer's disease shows potential for long-term growth, with sequential sales improvements noted over the past four quarters [6][10] - Leqembi has been launched in multiple countries and is expected to generate significant sales due to the unmet need in Alzheimer's treatment [7] - Skyclarys is witnessing strong demand trends, particularly in the U.S. and EU, with ex-U.S. sales projected to become a more significant growth driver in 2025 [9] Financial Outlook - Biogen's total revenues rose by 7% in the first half of 2025, driven by new drug sales, although the overall revenue for 2025 is projected to remain flat compared to 2024 [11][12] - The contribution from new drugs is increasing, but it is not yet sufficient to offset the declining revenues from MS drugs and Spinraza [12] Valuation and Estimates - Biogen's stock has declined by 2.2% this year, contrasting with an 8.7% increase in the industry [13] - The company's shares are trading at a forward price/earnings ratio of 9.49, lower than the industry average of 15.88 and its own 5-year mean of 13.55 [15] - The Zacks Consensus Estimate for 2025 earnings has increased from $14.87 to $15.68 per share over the past 90 days [16]

Company Overview - Biogen Inc. is valued at a market cap of $22.1 billion and specializes in therapies for neurological, neurodegenerative, and rare diseases [1] - The company has a strong presence in neuroscience, focusing on conditions such as multiple sclerosis (MS), spinal muscular atrophy (SMA), and Alzheimer's disease [1] Earnings Forecast - Biogen is scheduled to announce its fiscal Q3 earnings for 2025 on October 30, with analysts projecting a profit of $3.94 per share, a decrease of 3.4% from $4.08 per share in the same quarter last year [2] - For the current year, analysts expect Biogen to report an EPS of $15.83, down 3.9% from $16.47 in fiscal 2024 [3] Stock Performance - Over the past 52 weeks, Biogen's shares have declined by 19.5%, underperforming the S&P 500 Index's increase of 16.3% and the Health Care Select Sector SPDR Fund's drop of 6% [4] - Following the release of Q2 2025 results, Biogen's shares climbed 1.1%, with adjusted EPS of $5.47 and revenues of $2.65 billion exceeding analyst expectations [5] Analyst Ratings - Wall Street analysts have a "Moderate Buy" rating for Biogen, with 14 recommending "Strong Buy," 1 indicating "Moderate Buy," and 19 suggesting "Hold" [6] - The mean price target for Biogen is $173.21, indicating a potential upside of 15.8% from current levels [6]

Core Insights - Zorevunersen shows potential as a disease-modifying treatment for Dravet syndrome, with significant improvements in cognition and behavior observed over two years, contrasting with minimal changes in standard care [1][2][3] - In open-label extension studies, 95% of patients reported improvements in overall clinical status after three years of treatment with zorevunersen [1][2] Company Overview - Biogen Inc. and Stoke Therapeutics are collaborating on the development of zorevunersen, an investigational antisense oligonucleotide aimed at treating Dravet syndrome by increasing functional NaV1.1 protein production [8][9] - Zorevunersen has received orphan drug designation from the FDA and EMA, as well as Breakthrough Therapy Designation for specific mutations in the SCN1A gene [8] Clinical Data - The ongoing open-label extension studies indicate long-term benefits of zorevunersen on seizures, cognition, and behavior, supporting its potential for disease modification [3][4] - Safety data from the studies show that zorevunersen is generally well tolerated, with treatment-emergent adverse events (TEAEs) reported in 30% of patients in Phase 1/2a studies and 53% in open-label extension studies [4] Disease Context - Dravet syndrome is characterized by severe seizures and significant cognitive and behavioral impairments, with over 90% of patients experiencing seizures despite the best available treatments [7] - The estimated prevalence of Dravet syndrome in the U.S. is around 16,000 patients, with no approved disease-modifying therapies currently available [7][17]