Core Points - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab, which was initially adopted in November 2024, allowing the European Commission (EC) to resume its decision-making process for marketing authorization [1][2] - Lecanemab is currently under regulatory review in 18 countries and regions, with approvals already granted in multiple countries including the U.S., Japan, and China [7] - The approval of lecanemab would address the significant unmet need for new treatment options for Alzheimer's disease, which currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with Alzheimer's dementia in Europe [3] Company Collaboration - Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with Biogen co-commercializing and co-promoting the product [5][9] - The collaboration between Eisai and Biogen for Alzheimer's disease treatments has been ongoing since 2014, with Eisai holding final decision-making authority [9] - Eisai has a long-term collaboration with BioArctic for the development and commercialization of Alzheimer's treatments, having obtained global rights for lecanemab in December 2007 [10][11] Clinical Studies - The Phase 3 clinical study AHEAD 3-45 for individuals with preclinical Alzheimer's disease is ongoing, funded by the National Institute on Aging, Eisai, and Biogen [8] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing and includes lecanemab as the backbone anti-amyloid therapy [8]

Biogen TodayBIIBBiogen$136.54 -0.04 (-0.03%) 52-Week Range$128.51▼$238.00P/E Ratio12.20Price Target$211.85Add to WatchlistBiogen Inc. NASDAQ: BIIB has steadily declined since peaking at $468.55 in 2021, as shares are trading down 70.64% from those highs to 12-year lows at $137.33. The medical sector biotechnology company is trading at historically low valuations at a 12.41 price-earnings (P/E) ratio, which is less than half of the industry average P/E of 29.52. Its price-book (P/B) ratio is 1.2, significan ...

If you like what you have just read and want to receive at least 4 exclusive stock tips every week focused on Pharma, Biotech and Healthcare, then join me at my marketplace channel, Haggerston BioHealth . Invest alongside the model portfolio or simply access the investment bank-grade financial models and research. I hope to see you there.Biogen (NASDAQ: BIIB ) reported its Q4 and full-year 2024 earnings on Wednesday, 12th February. I last covered the company for Seeking Alpha after it had announced its Q3 e ...

On Wednesday, Biogen Inc BIIB reported fourth-quarter adjusted EPS of $3.44, up 17%, beating the consensus of $3.35.The company reported sales of $2.46 billion, up 2% year over year on constant currency and 3% on a reported basis, beating the consensus of $2.40 billion.Needham analyst Ami Fadia expects challenges in the multiple sclerosis segment, as growth from key product launches isn’t enough to make up for declines.While Leqembi sales performed well outside the U.S. and Skyclarys is set to grow internat ...

Biogen Inc BIIB reported better-than-expected earnings for its fourth quarter on Wednesday.The company posted fourth-quarter adjusted EPS of $3.44, up 17%, beating the consensus of $3.35. The company reported sales of $2.46 billion, up 2% year over on constant currency and 3% on a reported basis, beating the consensus of $2.40 billion.Multiple sclerosis revenue of $1.07 billion decreased by 8% (down 9% on constant currency). The multiple sclerosis drug Tysabri sales were down to $415.4 million from $464.7 m ...

Financial Performance - Net cash flow from operating activities rose to $2,875.5 million in 2024, an 85.9% increase compared to $1,547.2 million in 2023[491]. - Cash and cash equivalents increased to approximately $2.4 billion as of December 31, 2024, compared to approximately $1.0 billion as of December 31, 2023, primarily due to operational cash generation and proceeds from asset sales[486]. - The company reported a decrease of $259.3 million in accounts receivable, net, related to ongoing operations[488]. Investment Activities - The company incurred a net cash outflow of $799.2 million in investing activities in 2024, a significant decrease from $4,101.0 million in 2023, primarily due to cash payments for the acquisition of HI-Bio[491]. - Cash generated from operations included $437.5 million received from Samsung BioLogics related to the sale of a 49.9% equity interest in Samsung Bioepis[486]. - The increase in cash and cash equivalents was offset by $1.15 billion used for the acquisition of HI-Bio and $650.0 million for the repayment of the 2023 Term Loan[486]. Debt and Liabilities - The current portion of debt increased by $1.6 billion, primarily due to the reclassification of $1.75 billion of Senior Notes from long-term to short-term[488]. - As of December 31, 2024, the company's outstanding long-term debt was $4,547.2 million[496]. - The company has accrued income tax liabilities of approximately $234.0 million under the Transition Toll Tax as of December 31, 2024[520]. Acquisitions and Future Commitments - The company recognized $279.3 million of short-term contingent consideration from the acquisition of HI-Bio, contributing to a $184.1 million increase in accrued expenses[488]. - The company may pay up to $650.0 million in potential future milestone payments related to the acquisition of HI-Bio, with an acquisition-date fair value of approximately $485.1 million[513]. - The company could trigger potential future milestone payments of up to approximately $3.8 billion based on development plans as of December 31, 2024[515]. Capital Expenditures and Facilities - The company is constructing a new manufacturing facility in North Carolina with an estimated total investment of $195.0 million, expected to be completed in 2025[502]. - The company has approximately $509.2 million in cancellable future commitments based on existing CRO contracts as of December 31, 2024[518]. Revenue Recognition and Accounting Practices - The company recognizes product revenue when the customer obtains control of the product, typically upon delivery[527]. - The company amortizes intangible assets related to marketed products using the economic consumption method based on revenue generated from those products[542]. - The fair value of contingent consideration from business combinations is revalued each reporting period, with changes recorded as adjustments to gain or loss on fair value remeasurement[544]. Impairment and Reserves - For the year ended December 31, 2024, impairment charges incurred were approximately $60.2 million related to clinical programs acquired from Reata and Samsung Bioepis[541]. - The company estimates reserves for discounts and allowances based on historical experience, current contractual requirements, and market trends[530]. - As of December 31, 2024, a 10.0% change in discounts, contractual adjustments, and reserves would have resulted in a decrease of pre-tax earnings by approximately $351.9 million[531].

Biogen (BIIB) reported fourth-quarter 2024 adjusted earnings per share (EPS) of $3.44, which beat the Zacks Consensus Estimate of $3.42. Earnings rose 17% year over year on a reported basis, boosted by the company’s cost-cutting efforts.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.Total revenues came in at $2.46 billion, up 3% year over year on a reported basis and 2% on a constant-currency basis. Lower sales of Biogen’s key multiple sclerosis (MS) drugs like Tecfidera and Tysabri ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $2.5 billion, representing a 3% growth from Q4 2023. For the full year 2024, total revenue was $9.7 billion, a decline of 2% from 2023 [61][62] - Non-GAAP diluted EPS for Q4 2024 was $3.44, a 17% increase compared to Q4 2023. Full year 2024 non-GAAP diluted EPS was $16.47, a 12% increase from 2023 [61][62] - Free cash flow for Q4 2024 was $722 million, totaling $2.7 billion for the full year, an improvement of $1.4 billion from 2023 [62][71] Business Line Data and Key Metrics Changes - Multiple sclerosis (MS) product revenue declined approximately 8% at actual currency and 9% at constant currency compared to Q4 2023, primarily due to increased competition [63] - Rare disease franchise revenue was $535 million in Q4 2024, a growth of 13% at actual currency and 15% at constant currency from Q4 2023. SKYCLARYS revenue was $102 million, an increase of 83% year-over-year [65][66] - LEQEMBI generated approximately $87 million in global in-market sales in Q4 2024, up about 30% sequentially from Q3 2024 [68] Market Data and Key Metrics Changes - The decline in MS product revenue was driven by competition, including the impact of biosimilars and generics entering the market [63][74] - The company is seeing strong growth in international markets, particularly in Asia, where the single-payer system facilitates quicker access to treatments [29][30] Company Strategy and Development Direction - The company is focused on building a new phase of growth through innovative product launches in Alzheimer's, Friedreich's ataxia, depression, and ALS [9][10] - A significant restructuring of the pipeline has been undertaken to prioritize key projects, with expectations of multi-billion dollar potential from upcoming developments [12][39] - The company aims to reduce operating expenses while reallocating resources towards growth initiatives [13][14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by increased competition in the MS market but expressed optimism about the growth potential from new product launches [8][15] - The company is committed to investing in its pipeline and believes that the current portfolio could exceed the revenue generated from its existing biopharmaceutical business at peak sales [12][39] - Management emphasized the importance of early treatment initiation in Alzheimer's and the potential for LEQEMBI to stabilize and improve patient outcomes [52][130] Other Important Information - The company is transitioning to a new CFO, Robin Kramer, following Mike McDonnell's retirement [79] - The company expects a mid-single-digit percentage decline in total revenue for 2025, primarily due to the MS business, but anticipates strong growth from new product launches [72][73] Q&A Session Summary Question: What is your latest thinking on the capacity preference and potential timelines for external BD? - Management expressed excitement about the pipeline and emphasized the importance of internal research as a primary source of innovation while remaining open to external collaborations [83][84] Question: Can you walk through how important blood-based diagnostics are for LEQEMBI? - Management highlighted the significance of accurate diagnosis and the potential for blood-based diagnostics to replace PET scans, with several companies working on FDA-approved tests [94][96] Question: Can you elaborate on the dynamics of SKYCLARYS in the U.S.? - Management discussed the use of AI for patient identification and the importance of genetic testing, noting that reimbursement is not a significant issue in the U.S. [107][113] Question: Could you provide more flavor on SPINRAZA dynamics in the U.S.? - Management noted the competitive landscape and the importance of efficacy in treatment, along with plans for a new device to improve patient experience [119][122] Question: Do you feel you can achieve sustainable revenue growth based on current products? - Management indicated that while there is a headwind from the MS business, products like LEQEMBI have the potential to drive growth and meet significant unmet needs in Alzheimer's [130][131]

Biogen Inc. (BIIB) came out with quarterly earnings of $3.44 per share, beating the Zacks Consensus Estimate of $3.42 per share. This compares to earnings of $2.95 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 0.58%. A quarter ago, it was expected that this company would post earnings of $3.77 per share when it actually produced earnings of $4.08, delivering a surprise of 8.22%.Over the last four quarters, the company has su ...

This presentation and the discussions during this conference call contains forward-looking statements, relating to: our strategy and plans; potential of, and expectations for, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, and efficacy of our and our collaboration partners' products and in ...