The market expects Biogen Inc. (BIIB) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on May 1, 2025, might help the stock move higher if these key numbers are better ...

Core Viewpoint - Biogen is expected to report first-quarter 2025 results on May 1, with sales and earnings estimates at $2.24 billion and $3.34 per share, respectively. The company faces challenges from declining sales of multiple sclerosis (MS) drugs, which may be offset by revenues from new drugs [1][2][5]. Sales Performance of MS Drugs - Sales of Biogen's MS drugs, including Tecfidera and Tysabri, are anticipated to decline due to increased competition and the introduction of generic versions in various markets [2][5]. - The Zacks Consensus Estimate for Tecfidera sales is $199.0 million, while the internal estimate is $185.7 million. For Tysabri, the estimates are $363.0 million and $348.6 million, respectively [3][4]. - Vumerity's sales rose in the fourth quarter due to higher demand, with estimates for the first quarter at $141.0 million (Zacks) and $139.8 million (internal) [4]. Impact of Biosimilars and Generics - The decline in MS revenues is expected to be more pronounced in 2025 due to the anticipated entry of biosimilars for Tysabri and generics for Tecfidera in certain European markets [5]. Other Drug Sales - Spinraza's sales improved in the fourth quarter, but demand may have decreased in the first quarter, with estimates at $364.0 million (Zacks) and $338.1 million (internal) [6]. - Sales of Skyclarys for Friedreich's ataxia are expected to rise year-over-year, with estimates at $110.0 million (Zacks) and $111.4 million (internal) [7]. - Zurzuvae's launch has exceeded expectations, with strong patient demand likely contributing to improved sales in the first quarter [8][9]. Alzheimer's Collaboration and Revenues - Revenues from contract manufacturing, royalties, and Alzheimer's collaboration are expected to rise, particularly from the drug Leqembi, which has shown strong sales growth in recent quarters [10][11]. - Leqembi's sales have improved sequentially, with strong growth noted in China and Japan, and it was recently approved in the European Union [11][12]. Overall Revenue Expectations - Overall revenues for the first quarter of 2025 are expected to be negatively impacted by seasonality, higher discounts, and channel dynamics in the U.S., along with foreign exchange headwinds [13]. Key Events - Biogen announced a collaboration with Stoke Therapeutics to develop zorevunersen for Dravet syndrome, with a pivotal study expected to begin in the first quarter of 2025 [14]. Earnings Surprise History - Biogen has consistently beaten earnings estimates in the past four quarters, with an average earnings surprise of 11.8%. However, the current model does not predict a beat for the upcoming quarter, with an Earnings ESP of -15.8% [15][16][17].

Core Viewpoint - The European Commission has granted marketing authorization for Leqembi (lecanemab) to treat early Alzheimer's disease, marking a significant regulatory milestone for Biogen and Eisai [1][4][7]. Company Developments - Biogen's partner, Eisai, is responsible for the clinical development and regulatory submissions for Leqembi, although both companies co-commercialize the drug [2]. - Biogen's stock has decreased by 23.5% year-to-date, contrasting with a 6.5% decline in the industry [3]. Regulatory Approval Process - The approval for Leqembi followed a series of delays, including a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July 2024 [4][5]. - The CHMP initially raised concerns about the drug's safety, particularly regarding amyloid-related imaging abnormalities (ARIA) [6]. - After reassessing new safety data, the CHMP reaffirmed its positive opinion for Leqembi in February 2025 [9]. Market Performance - Leqembi has been approved in multiple countries, including the United States, China, Japan, and Great Britain [10]. - Sales of Leqembi showed a sequential improvement, with Eisai reporting nearly $87 million in global revenues in Q4 2024, reflecting a 30% increase [11]. Future Prospects - A less frequent maintenance intravenous dosing version of Leqembi was approved by the FDA in January 2025, with a subcutaneous autoinjector under review [12]. - Both companies believe Leqembi has the potential to achieve blockbuster sales due to the significant unmet medical need for Alzheimer's treatments [12]. Competitive Landscape - Leqembi and Eli Lilly's Kisunla are currently the only two FDA-approved drugs for early symptomatic Alzheimer's disease [13]. - Both drugs target the reduction of amyloid beta (Aβ) plaque in the brain, which is associated with cognitive decline in Alzheimer's patients [14].

Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology [1][2] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][3] Company Overview - Eisai Co., Ltd. and Biogen Inc. are collaborating on the development and commercialization of lecanemab, with Eisai leading the global development and regulatory submissions [2][8] - The approval of lecanemab in the EU is the thirteenth approval globally, following its benefits to thousands of patients in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities and healthcare providers to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients with early Alzheimer's disease [4][6] - In the trial, lecanemab reduced clinical decline on the CDR-SB scale by 31% at 18 months compared to placebo [4][6] - The secondary endpoint showed a 33% less decline in daily living activities for patients treated with lecanemab compared to placebo [4][6] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, indicating a significant unmet need for effective treatments [1][6] - Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils, which are key contributors to neuronal injury in Alzheimer's disease [1][4] - The approval of lecanemab represents a landmark advancement in a field that has seen little innovation over the past two decades [2][6]

Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2][6] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are non-carriers or heterozygotes of the ApoE ε4 gene [1][2][6] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][2] Company Overview - Eisai and Biogen are collaborating on the development and commercialization of lecanemab, with Eisai leading global regulatory submissions and having final decision-making authority [2][10] - The approval of lecanemab in the EU is the thirteenth approval globally, following its success in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients and demonstrated a 31% reduction in clinical decline on the CDR-SB scale at 18 months compared to placebo [6][7] - The trial showed that lecanemab reduced the mean change from baseline on the CDR-SB score by 0.535 points compared to placebo [6][7] - Secondary endpoints indicated a 33% less decline in the ADCS MCI-ADL score for lecanemab compared to placebo at 18 months [7] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, highlighting a significant unmet need for effective treatments [1][2][6] - Lecanemab is positioned as a groundbreaking treatment in a field that has seen little innovation over the past two decades [2][6] Safety Profile - Common adverse reactions reported in the clinical trial included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%) [7] - The treatment is subject to additional monitoring to quickly identify new safety information [4]

Company Overview - Biogen Inc. (BIIB) shares increased by 5.7% to close at $120.49, following a broader market rally after President Trump's announcement of a 90-day pause on tariffs against non-retaliating countries [1] - The stock had previously experienced a 20.6% loss over the past four weeks [1] Earnings Expectations - Biogen is expected to report quarterly earnings of $3.59 per share, reflecting a year-over-year decline of 2.2% [2] - Revenue projections stand at $2.24 billion, also down 2.2% from the same quarter last year [2] Stock Performance Insights - The consensus EPS estimate for Biogen has remained unchanged over the last 30 days, indicating a lack of upward momentum in earnings estimate revisions [3] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [3] Industry Comparison - Biogen operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Qiagen (QGEN), saw a 6.8% increase in its stock price, closing at $41.43 [3] - Qiagen's consensus EPS estimate is $0.49, representing a year-over-year increase of 4.3%, with its Zacks Rank also at 3 (Hold) [4]

Core Viewpoint - Biogen's investigational Alzheimer's disease drug, BIIB080, has received fast track designation from the FDA, which may expedite its development and review process [1][2]. Group 1: Fast Track Designation Benefits - Fast track designation aims to facilitate the development and expedite the review of drugs addressing serious conditions and unmet medical needs [2]. - The designation allows for rolling review, enabling Biogen to submit completed sections of its regulatory filing for BIIB080 as they become available, potentially speeding up the review process [2]. Group 2: BIIB080 Overview - BIIB080 is an investigational antisense oligonucleotide therapy targeting tau protein, which is linked to neurodegeneration and cognitive decline in Alzheimer's disease [5][6]. - The drug is currently being evaluated in the phase II CELIA study for early-stage Alzheimer's, with patient enrollment recently completed and data expected next year [5][6]. - Previous phase Ib study data indicated that BIIB080 treatment resulted in dose-dependent reductions in tau protein levels in cerebrospinal fluid and decreased tau buildup in the brain, along with positive trends in cognitive and functional measures [6]. Group 3: Partnership and Market Context - BIIB080 is developed in partnership with Ionis Pharmaceuticals, from which Biogen licensed exclusive global rights in December 2019, with Ionis eligible for royalties on potential sales [7]. - In the Alzheimer's drug market, two FDA-approved drugs, Leqembi and Kisunla, are currently available, both targeting amyloid beta plaque accumulation, a primary cause of cognitive decline [8][9].

Core Viewpoint - The FDA has granted Fast Track designation to Biogen's investigational therapy BIIB080 for Alzheimer's disease, highlighting the urgent need for innovative treatments targeting tau pathology [1][2]. Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on pioneering innovative science to deliver new medicines and create value for shareholders and communities [5]. Product Development - BIIB080 is the first tau-targeting antisense oligonucleotide (ASO) therapy in clinical development for Alzheimer's disease, currently evaluated in the global Phase 2 CELIA study for individuals with early-stage disease [2][3]. - Previous Phase 1b study results indicated dose-dependent reductions in soluble tau protein in cerebrospinal fluid and decreases in aggregated tau pathology in the brain, with favorable trends in exploratory clinical outcomes [2][3]. - The Phase 2 CELIA study is fully enrolled, with data readout expected in 2026 [2]. Licensing and Collaboration - In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals to obtain a worldwide, exclusive, royalty-bearing license for the development and commercialization of BIIB080 [4].

Core Viewpoint - Biogen Inc. is establishing a new global headquarters at Kendall Common in Cambridge, Massachusetts, as part of a multi-year real estate consolidation plan, aiming to enhance collaboration and innovation within the company and the local life sciences ecosystem [1][2][5]. Company Developments - The new headquarters will centralize Biogen's research and development, technical operations, and commercial organizations into a co-located innovation hub, scheduled to open in 2028, coinciding with the company's 50th anniversary [1][2][5]. - Biogen has signed a 15-year lease for approximately 580,000 square feet of office and research space, partnering with MIT Investment Management Company and BioMed Realty for the development [2][5]. Industry Impact - The establishment of the new headquarters is seen as a significant milestone for Massachusetts, reinforcing its position as a leader in the life sciences sector and fostering collaboration among scientific minds and institutions [2][3][4]. - The Biogen CoLab will be included in the new facility, serving as a community laboratory aimed at preparing students and adults for careers in life sciences and healthcare, thus contributing to talent generation in the region [4][5]. Facility Features - The state-of-the-art facility will include modern laboratories, upgraded workspaces, and sustainable design elements, such as advanced water conservation measures and energy-efficient systems, to optimize the working environment for employees and partners [3][4].

Core Viewpoint - Biogen Inc. has seen a slight increase in share price of approximately 1.1% since the last earnings report, outperforming the S&P 500, but there are concerns about potential downward trends leading up to the next earnings release [1]. Group 1: Earnings Estimates - Estimates for Biogen have trended downward over the past month, with a consensus estimate shift of -9.02% [2]. - The overall direction and magnitude of estimate revisions indicate a downward shift, leading to a Zacks Rank of 3 (Hold) for Biogen, suggesting an expectation of in-line returns in the coming months [4]. Group 2: VGM Scores - Biogen currently holds a subpar Growth Score of D, a Momentum Score of C, and an impressive Value Score of A, placing it in the top 20% for value investment strategy [3]. - The aggregate VGM Score for Biogen is C, which is relevant for investors not focused on a single strategy [3]. Group 3: Industry Performance - Biogen is part of the Zacks Medical - Biomedical and Genetics industry, where Gilead Sciences has gained 7% over the past month [5]. - Gilead reported revenues of $7.57 billion for the last quarter, reflecting a year-over-year increase of +6.4%, with an EPS of $1.90 compared to $1.72 a year ago [5]. - Gilead is expected to post earnings of $1.73 per share for the current quarter, indicating a year-over-year change of +231.1%, and has a Zacks Rank of 2 (Buy) with a VGM Score of B [6].