Financial Performance - Total revenue increased by 3% year-over-year to $2.53 billion in Q3 2025[59, 61, 64] - Launch products revenue grew 67% year-over-year, reaching $257 million in Q3 2025[19, 59] - GAAP diluted EPS increased by 19% year-over-year to $3.17, while Non-GAAP diluted EPS increased by 18% year-over-year to $4.81[59, 64] - The company generated $1.23 billion of free cash flow in Q3 2025[59] Product Performance - LEQEMBI achieved $121 million in in-market sales, demonstrating sustained sequential global demand growth[19, 48] - SKYCLARYS revenue grew 30% year-over-year and is now available in 34 markets globally[19, 52] - ZURZUVAE revenue increased by over 150% year-over-year, with 80% of prescriptions for first-line therapy[19, 55] Pipeline Advancement - Litifilimab Phase 3 studies for SLE are fully enrolled, with data expected in H2 2026[19, 34, 41] - A Phase 1 study was initiated for BIIB142, an IRAK4 degrader for autoimmune diseases[19, 21, 34, 35] - The company expects 3-4 potential new INDs[34, 35] Financial Guidance - Full year 2025 Non-GAAP diluted EPS is expected to be between $14.50 and $15.00[59] - Full year 2025 total revenue is expected to be approximately flat to increasing 1% at constant currency[59, 74] - The company expects to deliver $1 billion gross savings / $800 million net savings as part of the "Fit for Growth" initiative by the end of 2025[24, 79]

Core Insights - Biogen Inc. reported quarterly earnings of $4.81 per share, exceeding the Zacks Consensus Estimate of $3.89 per share, and showing an increase from $4.08 per share a year ago, resulting in an earnings surprise of +23.65% [1] - The company generated revenues of $2.53 billion for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 8.31% and reflecting a year-over-year increase from $2.47 billion [2] - Biogen has outperformed consensus EPS estimates three times over the last four quarters and has topped consensus revenue estimates four times during the same period [2] Earnings Outlook - The sustainability of Biogen's stock price movement will largely depend on management's commentary during the earnings call and future earnings expectations [3][4] - The current consensus EPS estimate for the upcoming quarter is $3.38 on revenues of $2.27 billion, while for the current fiscal year, the estimate is $15.74 on revenues of $9.68 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Biogen belongs, is currently ranked in the top 38% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Core Insights - Biogen has lowered its full-year adjusted-earnings expectations despite a rise in third-quarter profit driven by its Alzheimer's drug and treatments for rare diseases [1] Financial Performance - The third-quarter profit increased due to strong performance from the Alzheimer's drug and rare-disease treatments [1] - Full-year adjusted-earnings expectations have been cut, indicating potential challenges ahead [1]

Revenue and Income - For the three months ended September 30, 2025, total revenue was $2,534.7 million, an increase from $2,465.8 million for the same period in 2024, representing a growth of 2.8%[23] - Product revenue, net for the nine months ended September 30, 2025, was $5,452.1 million, compared to $5,380.9 million in 2024, reflecting an increase of 1.3%[23] - Net income attributable to Biogen Inc. for the three months ended September 30, 2025, was $466.5 million, up from $388.5 million in 2024, marking a growth of 20.1%[25] - Basic earnings per share for the three months ended September 30, 2025, was $3.18, compared to $2.67 in 2024, an increase of 19.1%[23] - Net income for the nine months ended September 30, 2025, was $1,341.8 million, slightly down from $1,365.5 million in the same period of 2024, reflecting a decrease of 1.7%[29] Expenses and Costs - Research and development expenses for the three months ended September 30, 2025, were $436.1 million, down from $516.2 million in 2024, a decrease of 15.5%[23] - Total cost and expense for the three months ended September 30, 2025, was $1,977.4 million, a decrease from $2,014.8 million in 2024, reflecting a reduction of 1.8%[23] - The company reported a depreciation and amortization expense of $579.7 million for the nine months ended September 30, 2025, up from $489.2 million in 2024, reflecting an increase of 18.5%[29] - The company incurred excess and obsolescence charges related to inventory of $13.9 million for the nine months ended September 30, 2025, down from $68.7 million in 2024, a decrease of 79.8%[29] Assets and Liabilities - Total assets increased to $29,207.5 million as of September 30, 2025, up from $28,049.3 million as of December 31, 2024, representing a growth of 4.1%[28] - Cash and cash equivalents rose to $3,862.8 million, compared to $2,375.0 million at the end of 2024, marking a significant increase of 62.5%[29] - Total current liabilities decreased to $3,290.0 million as of September 30, 2025, from $5,528.8 million at the end of 2024, a reduction of 40.5%[28] - The total equity of Biogen Inc. increased to $18,207.5 million as of September 30, 2025, compared to $16,716.0 million at the end of 2024, representing a growth of 8.9%[28] Collaborations and Acquisitions - The company reported collaboration revenue from Alzheimer's programs of $42.7 million for the three months ended September 30, 2025, significantly up from $18.6 million in 2024, an increase of 129.0%[23] - Biogen plans to acquire Alcyone Therapeutics for an upfront cash payment of $85.0 million, with additional milestone payments based on development and regulatory achievements[56][57] - The acquisition of HI-Bio was completed on July 2, 2024, for a total consideration of approximately $1.622 billion, including $1.15 billion in cash and up to $650.0 million in contingent milestone payments[60][65] - The lead asset from HI-Bio, felzartamab, has received Breakthrough Therapy Designation and orphan drug designation from the FDA for multiple indications[60] Revenue by Product and Treatment - Product revenue for the three months ended September 30, 2025, reached $1,846.9 million, a slight increase from $1,769.4 million in the same period of 2024[91] - Total product revenue from Multiple Sclerosis treatments for the three months ended September 30, 2025, was $1,061.5 million, compared to $1,053.9 million in the same period of 2024[91] - Revenue from Rare Disease treatments for the three months ended September 30, 2025, was $533.3 million, an increase from $494.8 million in the same period of 2024[91] - Revenue from Multiple Sclerosis treatments totaled $3,121.7 million for the nine months ended September 30, 2025, compared to $3,279.6 million in 2024, indicating a decrease of 4.8%[93] Strategic Initiatives and Restructuring - The 2023 Fit for Growth Restructuring Program is expected to generate approximately $1.0 billion in gross operating expense savings by the end of 2025, with net headcount reductions of about 1,400 employees and total restructuring charges estimated at $310.0 million[82] - For the three months ended September 30, 2025, total charges from the restructuring program amounted to $8.3 million, compared to $17.2 million for the same period in 2024[84] - The restructuring reserve as of September 30, 2025, was $19.2 million, down from $40.2 million in 2024[89] Financial Instruments and Market Conditions - The company issued $1.75 billion in Senior Notes in May 2025 and redeemed its 4.050% Senior Notes due September 15, 2025, prior to maturity[137] - The total marketable equity securities decreased to $103.9 million as of September 30, 2025, from $668.7 million at the end of 2024, primarily due to a decrease in the fair value of investments[140] - Unrealized losses on foreign currency forward contracts totaled $112.9 million as of September 30, 2025, compared to $0.3 million at the end of 2024[149] - The company reported net unrealized losses of approximately $103.4 million on foreign currency contracts, expected to be settled over the next 24 months[149] Tax and Compensation - The effective tax rate for the three months ended September 30, 2024, was 16.3%, an increase from 13.9% in the same period in 2023[179] - Share-based compensation expense for the three months ended September 30, 2024, was $75.3 million, down from $128.7 million in the same period in 2023, reflecting a 41.5% decrease[176] - The company recognized approximately $56.4 million in equity-based compensation expense related to the acquisition of HI-Bio, with $42.5 million charged to research and development expenses[174]

Core Viewpoint - Biogen has lowered its annual profit forecast due to anticipated R&D related charges from acquisitions, expecting a hit of $1.25 per share in the fourth quarter [1] Financial Impact - The company expects a reduction of $1.25 per share in its earnings due to R&D related charges [1]

Financial Performance - Biogen cut its full-year profit guidance [1] Business Strategy - The company is doing deals to offset the decline of its aging multiple sclerosis drugs [1] Cost Analysis - Higher costs are associated with the deals Biogen has been doing [1]

INCHEON, Korea--(BUSINESS WIRE)-- #BYOOVIZ--Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis' two ophthalmology assets: BYOOVIZ® (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ™ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe. Samsung Bioepis will have full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen b. ...

Market Overview - Global financial markets are experiencing optimism due to positive U.S.-China trade relations, a pharmaceutical breakthrough in Canada, and strong industrial profit growth in China [2][6] - U.S. pre-market indicators show S&P 500 futures up 0.9%, Nasdaq-100 futures up 1.3%, and Russell 2000 futures up 1% [2] Pharmaceutical Industry - Health Canada has granted conditional authorization for Eisai Co., Ltd. and Biogen Inc.'s drug LEQEMBI® (lecanemab) for early Alzheimer's disease, marking it as the first treatment targeting the underlying cause in Canada [3][8] - The approval is based on positive results from the Phase 3 Clarity AD study, where LEQEMBI reduced cognitive decline by 27% over 18 months compared to placebo [4] - The drug is already approved in 51 other countries, with significant implications for the estimated 771,000 Canadians living with dementia [4] Industrial Sector in China - China's industrial profits have seen substantial growth, attributed to government efforts to address industrial overcapacity and improve profitability [5][8] - These proactive measures are contributing to a more stable and profitable industrial landscape in China [5] Individual Stock Movements - Keurig Dr Pepper (KDP) shares rose 3.5% after reporting revenues that exceeded expectations and raising its full-year net sales growth outlook [7][8] - Carter's (CRI) shares fell 9% due to missed sales and operating margin targets [8][11] - Snowflake (SNOW) shares gained 2% after reaffirming its revenue guidance for the third quarter and fiscal year 2026 [11] - Cadence Bank (CADE) also saw a positive movement, increasing by 3.5% [11]

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]