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Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Designated for Priority Review in China
Globenewswire· 2026-02-09 02:00
Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. announced that the Biologics License Application for the subcutaneous formulation of LEQEMBI has been designated for Priority Review by the National Medical Products Administration of China, which could significantly enhance patient access to treatment [1][2]. Group 1: Product Development and Approval - The subcutaneous formulation (SC-AI) of LEQEMBI allows for a once-weekly home administration, contrasting with the current intravenous method that requires hospital visits every two weeks [3]. - The injection time for each autoinjector is approximately 15 seconds, which could streamline the treatment process and reduce healthcare resource utilization [3]. - Eisai estimates that there were 17 million patients with mild cognitive impairment or mild dementia due to Alzheimer's disease in China in 2024, a number expected to rise with the aging population [4]. Group 2: Market Access and Insurance - LEQEMBI was launched in China in June 2024 and has been included in the "Commercial Insurance Innovative Drug List," effective January 2026, which supports access to innovative medicines [5]. - Commercial insurance companies are expected to develop insurance products covering LEQEMBI based on this new list [5]. Group 3: Collaboration and Regulatory Strategy - Eisai leads the global development and regulatory submissions for LEQEMBI, with both Eisai and Biogen co-commercializing and co-promoting the product [6][11]. - The U.S. FDA approved the Biologics License Application for subcutaneous maintenance dosing of LEQEMBI in August 2025, with a supplemental application for initiation treatment accepted in January 2026 [8]. Group 4: Scientific Background - Lecanemab is a humanized monoclonal antibody targeting aggregated forms of amyloid-beta, which is believed to play a significant role in cognitive decline associated with Alzheimer's disease [8][10]. - The reduction of protofibrils may prevent the progression of Alzheimer's disease by mitigating neuronal damage and cognitive dysfunction [10]. Group 5: Company Overview - Eisai's corporate concept focuses on patient-centric healthcare, aiming to address unmet medical needs, particularly in neurology and oncology [13]. - Biogen, founded in 1978, is a leading biotechnology company that emphasizes innovative science to transform patient lives and create shareholder value [16].
Biogen Hits 52-Week High, Alzheimer's Drug Sales Jump
Yahoo Finance· 2026-02-08 22:31
Core Insights - Biogen Inc. reported better-than-expected fourth-quarter earnings with adjusted EPS of $1.99, surpassing the consensus estimate of $1.59 [1] - The company generated revenues of $2.28 billion, exceeding the consensus of $2.20 billion, although this represents a 7% decline on both a reported and constant currency basis [1] Drug Performance - Fiscal 2025 revenue from growth products increased by 19% year-over-year, which helped offset the decline in revenue from multiple sclerosis products, excluding Vumerity [2] - Leqembi, an Alzheimer's drug, generated collaboration revenue of $47 million, with in-market sales reaching approximately $134 million, reflecting a 54% increase [3] - Multiple sclerosis revenue totaled $917 million, down 14% year-over-year (15% decline on a constant currency basis), with Tysabri sales decreasing from $415.4 million to $397.5 million [3] Rare Disease Revenue - Revenue from rare diseases decreased by 4% year-over-year to $514.6 million, with Spinraza's revenue declining from $421.4 million to $356.2 million [4] - Spinraza's fourth-quarter revenue fell by 15% year-over-year, influenced by shipment timing outside the U.S., while full-year revenue was down 2% [4] New Product Contributions - Skyclarys, a drug for Friedreich's ataxia, reported revenues of $133.4 million during the quarter, up from $102.2 million a year ago [5] - Skyclarys saw a 30% increase in global patients on therapy in 2025, with U.S. revenue of approximately $89 million driven by demand growth [6] - Zurzuvae, a postpartum depression drug, achieved fourth-quarter revenue of approximately $66 million, indicating strong demand growth [6] - Vumerity's revenue grew by 3% year-over-year in the fourth quarter to $181.1 million [6] Management Commentary - The President and CEO of Biogen highlighted that the 2025 performance was driven by nearly $1 billion in revenue from LEQEMBI, SKYCLARYS, ZURZUVAE, and QALSODY, along with pipeline progression and the resilience of the MS franchise [7]
Biogen Inc. (NASDAQ:BIIB) Sees Positive Price Target Adjustment and Strong Market Activity
Financial Modeling Prep· 2026-02-07 04:06
Evan Seigerman from BMO Capital has set a new price target of $196 for Biogen Inc. (NASDAQ:BIIB), indicating a positive outlook on the company's performance.The stock's current price of $201.18 is approximately 2.57% above the new target, showcasing investor confidence and an 8.53% increase in market activity.Biogen's recent Q4 2025 earnings call provided insights into the company's financial health, with a focus on revenue, profit margins, and strategic initiatives.Biogen Inc. (NASDAQ:BIIB) is a leading bi ...
Biogen Inc. (NASDAQ:BIIB) Stock Update and Financial Performance Review
Financial Modeling Prep· 2026-02-07 02:11
Core Viewpoint - Biogen Inc. is a prominent biotechnology company specializing in therapies for neurological and neurodegenerative diseases, facing competition from major pharmaceutical companies in the neurology sector [1] Financial Performance - Biogen reported Q4 2025 earnings per share (EPS) of $1.99, exceeding the Zacks Consensus Estimate of $1.61, but reflecting a 42% decline from the previous year [3][6] - The company's total revenue for Q4 2025 was $2.28 billion, surpassing the Zacks Consensus Estimate of $2.21 billion, despite a 7% year-over-year decline [3][6] Revenue Drivers - The revenue decline was primarily due to weaker sales of key multiple sclerosis (MS) drugs such as Tecfidera and Tysabri, as well as the spinal muscular atrophy (SMA) drug Spinraza [4] - Increased sales from newer drugs like Leqembi, Skyclarys, and Zurzuvae partially offset the revenue decline from established products [4] Stock Performance - Following an optimistic 2026 adjusted EPS guidance projected between $15.25 and $16.25, Biogen's stock price rose to $201.18, marking an increase of 8.53% or $15.82 [4][6] - The stock has fluctuated between a low of $184.60 and a high of $202.41, with the latter being the highest price over the past year [5] Analyst Rating - On February 6, 2026, BMO Capital adjusted its rating for Biogen to "Market Perform," maintaining a "hold" action, while raising the price target from $165 to $196, indicating a more optimistic outlook [2]
Why Biogen Stock Surged Almost 9% Higher on Friday
The Motley Fool· 2026-02-07 00:47
Core Insights - Biogen has shown potential for returning to growth, with a significant stock price increase of nearly 9% following the release of its 2025 fundamentals, which exceeded analyst expectations for profitability [1][4]. Financial Performance - In Q4, Biogen reported total revenue of approximately $2.28 billion, a decline of 7% year-over-year, while non-GAAP net income fell to just under $294 million ($1.99 per share) from over $502 million in the previous year [2][4]. - The company's product revenue, the main contributor to total revenue, decreased by 9% to under $1.67 billion, with multiple sclerosis (MS) treatments experiencing a 14% drop to $917 million due to competition from generics and biosimilars [5][2]. Analyst Expectations - Despite the revenue decline, Biogen's headline numbers surpassed consensus analyst estimates, which predicted revenue of $2.21 billion and non-GAAP net income of $1.61 per share [4][2]. Future Guidance - Biogen provided guidance for 2026, expecting mid-single-digit revenue decline from 2025 results, with adjusted net income projected between $15.25 and $16.25, above the average analyst estimate of $14.92 [8][9]. - The company is moving beyond its historical reliance on the MS portfolio, with its "New Biogen" medicines achieving 6% sales growth and a strong pipeline expected to support future growth [9].
股价大涨8.53%! 百健利润展望强于预期!“瘦身术”砍成本+押注阿尔茨海默病药等新药产品线
美股IPO· 2026-02-07 00:35
Core Viewpoint - Biogen's forecast for 2026 profits exceeds Wall Street's average expectations, indicating that significant cost-cutting measures are mitigating the impact of declining sales from its multiple sclerosis (MS) products [1][3]. Financial Performance - Biogen reported Q4 2025 total revenue of approximately $2.279 billion, a year-over-year decline of 7%, but still above Wall Street expectations. Adjusted earnings per share (EPS) were $1.99, also exceeding analyst forecasts [4]. - For the full year 2025, total revenue reached $9.891 billion, reflecting a 2% year-over-year increase, with adjusted EPS at $15.28, down 7% year-over-year, both surpassing Wall Street expectations [4]. - The company anticipates a mid-single-digit percentage decline in overall revenue for 2026, continuing the operational pressure on its MS treatment business [3][4]. Product Performance and Pipeline - The revenue from new drugs, particularly Leqembi, is crucial for Biogen's growth. In 2025, combined revenue from Leqembi, Skyclarys, Zurzuvae, and Qalsody approached $1 billion [4]. - Leqembi's sales in Q4 2025 were approximately $134 million, up from $121 million in the previous quarter, but growth is constrained by systemic bottlenecks in the healthcare system [5][7]. - Biogen is focusing on reducing reliance on neuroscience by enhancing its rare disease portfolio through acquisitions and shifting research emphasis towards immunology [6][9]. Strategic Initiatives - CEO Chris Viehbacher has implemented strict cost discipline, including job cuts and the removal of certain drugs from the development pipeline, to support new product growth [7]. - The company is seeking FDA approval for a subcutaneous administration of Leqembi, which could improve accessibility and differentiate it from competitors [9]. - Biogen is also awaiting key trial data for several experimental drugs, including a new Alzheimer's treatment and litifilimab for lupus, which could further diversify its product offerings [10].
Biogen Shares Rise 3% After Q4 Beat and Upbeat 2026 Profit Outlook
Financial Modeling Prep· 2026-02-06 21:02
Core Viewpoint - Biogen Inc. reported stronger-than-expected fourth-quarter 2025 results, leading to a more than 3% increase in shares, and provided an optimistic profit outlook for 2026 [1] Financial Performance - Adjusted earnings per share for Q4 2025 were $1.99, exceeding the analyst consensus of $1.61 [1] - Revenue for the quarter was $2.28 billion, surpassing expectations of $2.21 billion, although it represented a 7% decline year over year [1] Growth Products - Growth products showed positive momentum, with revenue increasing by 6% year over year in the quarter [2] - Global in-market sales of LEQEMBI reached approximately $134 million, marking a 54% year-over-year increase [2] - ZURZUVAE generated about $66 million in revenue, indicating strong demand growth [2] - SKYCLARYS expanded its global patient base by roughly 30% in 2025 [2] 2026 Outlook - For fiscal 2026, Biogen forecasts adjusted earnings per share in the range of $15.25 to $16.25, above the analyst consensus of $14.92 [3] - The company anticipates total revenue to decline by a mid-single-digit percentage compared to 2025, with expected declines in multiple sclerosis products, excluding VUMERITY, partially offset by growth in newer therapies [3]
Biogen outlines $15.25-$16.25 EPS guidance for 2026 while advancing growth products and pipeline (NASDAQ:BIIB)
Seeking Alpha· 2026-02-06 19:16
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BIIB Beats on Q4 Earnings & Sales, Stock Gains on Upbeat '26 EPS View
ZACKS· 2026-02-06 17:30
Core Insights - Biogen reported fourth-quarter 2025 adjusted EPS of $1.99, exceeding the Zacks Consensus Estimate of $1.61, despite a 42% year-over-year decline in earnings [2][10] - Total revenues for the quarter were $2.28 billion, down 7% year over year, but above the Zacks Consensus Estimate of $2.21 billion, driven by weak sales of key drugs [3][10] Revenue Breakdown - Product sales decreased to $1.67 billion, a 9% decline year over year [4] - Revenues from anti-CD20 therapeutic programs increased by 12% to $521 million, including royalties from Roche's Ocrevus and Biogen's share of other drugs [4] - Contract manufacturing and royalty revenues fell 66% to $44 million, while Alzheimer's collaboration revenues rose to $47 million from $27 million year-over-year [5][6] Multiple Sclerosis (MS) Drug Performance - MS revenues totaled $917 million, down 14% year over year, impacted by generic competition for Tecfidera [7] - Tecfidera sales plummeted 51% to approximately $112 million, missing estimates, while Tysabri sales fell 4% to $397.5 million, beating estimates [8] - Vumerity sales increased by 3% to $181 million, but also missed estimates [7] Rare Disease Drug Performance - Spinraza sales declined over 15% to $356 million, missing estimates [9] - Skyclarys generated over $133 million in sales, up nearly 31% year over year, driven by demand growth [11] - Qalsody added $25 million in sales compared to $12 million in the previous year [11] Cost and Expense Management - Adjusted R&D expenses decreased by 6% to $478 million due to cost-saving initiatives [14] - Adjusted SG&A expenses rose 1% to $678 million, reflecting higher costs for new product launches [14] 2025 Financial Performance - Biogen's total revenues for 2025 reached $9.89 billion, surpassing estimates and showing a 2% year-over-year increase [15] - Earnings per share were $15.28, down 7% year over year, but above estimates [15] 2026 Guidance - Total revenues are expected to decline by a mid-single-digit percentage in constant currency terms, with adjusted EPS projected between $15.25 and $16.25, above consensus estimates [16] - Gross margin is expected to remain flat, with R&D and SG&A costs anticipated to be consistent year over year [17] Market Outlook - Despite challenges in the MS franchise and declining Spinraza sales, newer therapies like Leqembi, Skyclarys, and Zurzuvae are gaining traction [18][21] - The company is focused on building a multi-franchise portfolio through internal development and collaborations, with key pipeline products having a peak revenue potential of $14 billion [21][22]
How One Drug Heavy-Lifted Biogen's Fourth-Quarter Beat
Investors· 2026-02-06 14:59
Biogen Leans Heavily Onto One Drug In Fourth-Quarter Beat | Investor's Business DailyBREAKING: [Dow Leads Stocks Higher As Nvidia, Goldman Sachs Rally]---Biogen (BIIB) narrowly topped Wall Street's fourth- quarter expectations Friday, thanks to far better-than-expected sales of multiple sclerosis treatment Tysabri. But Tysabri's victory lap could be short-lived. In November, Sandoz launched its generic version of the multiple sclerosis drug in the U.S. Biosimilars have existed in Europe for years and Tysabr ...