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].

Core Insights - Biogen's key multiple sclerosis drugs, including Tecfidera and Tysabri, along with Spinraza for spinal muscular atrophy, are facing declining sales due to increased competition, leading to a 2% decline in total revenues in 2024, with a projected mid-single-digit percentage decline in 2025 [1][4][6] Group 1: Revenue Declines - Biogen's global MS revenues declined by 7% in 2024, with expectations of a steeper decline in 2025 due to the potential entry of Tysabri biosimilars in the U.S. and generic versions of Tecfidera in Europe [4] - Spinraza sales fell nearly 10% in 2024, attributed to competitive pressure and decreased demand, with little improvement anticipated in 2025 [4][10] Group 2: Competitive Landscape - The launch of multiple generic versions of Tecfidera in North America, Brazil, and Europe has negatively impacted its revenues [3] - Regulatory approvals for biosimilars of Tysabri in the U.S. and Europe are contributing to the competitive pressure faced by Biogen [3][5] Group 3: New Drug Potential - Biogen is optimistic about new drugs like Leqembi for Alzheimer's, Skyclarys for Friedreich's ataxia, and Zurzuvae for depression, which are seen as potential drivers for long-term growth [2][8] - Leqembi has shown sequential improvement in sales since its launch, with expectations for continued growth in 2025 [7][8] Group 4: Market Challenges - The FDA approval of Eli Lilly's Alzheimer's drug Kisunla poses significant competition to Leqembi [5] - Foreign exchange headwinds are expected to negatively impact 2025 revenues by 1%, alongside a projected $50 million to $100 million impact from the redesign of Medicare Part D [6] Group 5: Pipeline Developments - Biogen faced setbacks in its pipeline, including the discontinuation of Zurzuvae's development for major depressive disorder, which had a larger market potential than its current indication [5] - The acquisition of Reata Pharmaceuticals added Skyclarys to Biogen's portfolio, which is experiencing strong launch trends [9]

Core Insights - Biogen has initiated a phase III study for its candidate felzartamab in adult kidney transplant recipients with late antibody-mediated rejection (AMR), a major cause of transplant failure [1][2] - The study will enroll approximately 120 participants and aims to evaluate the efficacy and safety of felzartamab compared to a placebo, with a primary endpoint focused on AMR resolution by biopsy at 6 months [2] - Felzartamab has received Breakthrough Therapy designation from the FDA for the AMR indication [2] Pipeline Development - Biogen is exploring felzartamab for various immune-mediated diseases, indicating its potential as a "pipeline-in-a-product" [4] - Ongoing phase II studies for felzartamab include indications for primary membranous nephropathy (PMN) and Immunoglobulin A nephropathy (IgAN), with plans to start phase III studies in 2025 [5] - The candidate was acquired through Biogen's purchase of Human Immunology Biosciences in July last year, which included rights to felzartamab globally, excluding China [6] Financial Implications - Following the start of the phase III study, Biogen will make a milestone payment of $35 million to MorphoSys [7] - Biogen's stock has seen a decline of 36.6% over the past year, compared to an 8.5% decline in the industry [3]

Core Viewpoint - Biogen has initiated the Phase 3 TRANSCEND clinical study to evaluate the efficacy and safety of felzartamab in adult kidney transplant recipients with late antibody-mediated rejection (AMR) [1][2]. Company Overview - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create value for shareholders and communities [8]. - The company acquired Human Immunology Biosciences (HI-Bio) in July 2024, which holds exclusive rights to develop and commercialize felzartamab across various indications [4]. Drug Development - Felzartamab is an investigational human monoclonal antibody targeting CD38, with potential applications in various immune-mediated diseases [4]. - The Phase 3 TRANSCEND study will enroll approximately 120 kidney transplant recipients and is designed as a two-part, 52-week, double-blind, placebo-controlled trial [1][2]. - The primary endpoint of the study is the percentage of participants achieving resolution of AMR by biopsy at 6 months, with key secondary endpoints including changes in microvascular inflammation (MVI) score [2][5]. Market Context - AMR is a significant challenge in kidney transplantation, with around 23,000 patients in the U.S. affected by various forms of AMR [5]. - Current treatment options for late AMR are limited, highlighting the potential importance of felzartamab as a new therapeutic option if approved [2][7]. Future Plans - In addition to the TRANSCEND study, Biogen plans to initiate Phase 3 trials of felzartamab for IgA nephropathy and primary membranous nephropathy in 2025 [3]. - MorphoSys, the original developer of felzartamab, will receive a one-time milestone payment of $35 million from Biogen as part of the trial initiation [3].

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].