Core Insights - Health Canada has issued a Notice of Compliance with Conditions for LEQEMBI (lecanemab), marking it as the first treatment for early Alzheimer's disease (AD) targeting an underlying cause of the disease [1][3] - LEQEMBI has shown significant efficacy in reducing the rate of disease progression and slowing cognitive decline in adults with AD, with approvals in 51 countries and regions [2][11] Group 1: Product Information - LEQEMBI selectively binds to both soluble and insoluble amyloid-beta aggregates, reducing Aβ protofibrils and plaques in the brain [2] - The approval of LEQEMBI is based on the Phase 3 Clarity AD study, which met its primary and key secondary endpoints with statistically significant results [3][10] - In the Clarity AD study, LEQEMBI reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [10] Group 2: Market Context - Alzheimer's disease accounts for 60 to 80% of all dementia cases, with over 771,000 patients in Canada as of January 1, 2025, projected to rise to approximately 1 million by 2030 [4] - The annual care provided by family and friends for dementia patients is equivalent to 290,000 full-time jobs, expected to increase to 690,000 by 2050 [4] Group 3: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [5][14] - Eisai and BioArctic have collaborated since 2005 on the development and commercialization of AD treatments, with Eisai obtaining global rights for lecanemab in 2007 [15]

Core Viewpoint - Biogen is expected to exceed expectations in its third-quarter 2025 results, with earnings estimates at $3.89 per share and sales at $2.34 billion, following a previous quarter where earnings surpassed expectations by 39.2% [1] Factors Impacting Biogen - Lower sales of multiple sclerosis (MS) drugs are anticipated, particularly due to generic competition for Tecfidera and biosimilar competition for Tysabri, but this may be offset by revenue growth from new products [2][3] - The decline in MS revenue is expected to be more pronounced in the second half of the year, especially in the ex-U.S. market due to intensified competition [3] - Sales estimates for Tecfidera are $158 million (Zacks Consensus) and $162.9 million (model estimate), while Tysabri's estimates are $370 million and $346.9 million, respectively [3] Performance of Other Drugs - Vumerity's sales are projected to rise due to increased demand, with estimates at $173 million (Zacks) and $169.6 million (model) [4] - Spinraza's sales are likely to decline, with estimates at $373 million (Zacks) and $360 million (model) [4] - Sales of Skyclarys for Friedreich's ataxia are expected to improve, driven by demand growth and geographic expansion, although U.S. growth may be tempered by Medicare discount dynamics [5][6] - Zurzuvae's sales are also expected to rise due to strong patient demand, following its EU approval in September [7] Collaboration and Revenue Streams - Revenues from contract manufacturing, royalties, and Alzheimer's collaborations are expected to increase, particularly from Leqembi, which has shown consistent sales growth [8][10] - Leqembi's sales have improved sequentially over the past four quarters, with its recent approvals in various markets contributing to this growth [10][11] Earnings Surprise History - Biogen has a history of beating earnings estimates, achieving an average surprise of 10.16% over the last four quarters, although its stock has declined by 1.9% this year compared to a 9.2% industry increase [12] Earnings Prediction Model - The earnings prediction model indicates a likely earnings beat for Biogen, supported by a positive Earnings ESP of +1.08% and a Zacks Rank of 3 [14][15]

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]