[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]

Valued at a market cap of $22.1 billion, Biogen Inc. (BIIB) is a top biotechnology company. Headquartered in Cambridge, Massachusetts, it specializes in the discovery, development, and delivery of therapies for neurological, neurodegenerative, and rare diseases. Founded in 1978, Biogen has built a strong presence in neuroscience, focusing on addressing unmet medical needs in conditions such as multiple sclerosis (MS), spinal muscular atrophy (SMA), and Alzheimer’s disease. The biotech titan is scheduled t ...

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]

Core Insights - Stoke Therapeutics and Biogen announced longer-term follow-up analyses from ongoing open-label extension studies of zorevunersen, indicating its potential as a disease-modifying medicine for Dravet syndrome [1] Company Overview - Stoke Therapeutics is a biotechnology company focused on restoring protein expression through RNA medicine [1] - Biogen Inc. is a biotechnology company that collaborates with Stoke Therapeutics on the zorevunersen studies [1] Product Development - The ongoing studies of zorevunersen are aimed at evaluating its effectiveness in treating Dravet syndrome, a severe form of epilepsy [1] - The new results from the studies support the potential of zorevunersen as a disease-modifying treatment [1]

With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical companies.Allka Research's journey in the investment landscape is marked by a commitment to delivering substantial returns and strategic insights to its clients. In a world filled with complexities, Allka Re ...

New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo N ...

New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months TOKYO and CAMBRIDGE, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo N ...