A test tube is seen in front of displayed Biogen logo in this illustration taken on, December 1, 2021.Biogen on Thursday reported second-quarter earnings and revenue that topped estimates and hiked its full-year guidance, as the company's cost cuts showed progress and sales of its breakthrough Alzheimer's drug, Leqembi, and other new products beat expectations. Biogen now expects full-year adjusted earnings to come in at $15.75 to $16.25 per share, up from a previous forecast of $15 to $16 per share.The bio ...

Press Release Cambridge, Mass. – Aug. 1, 2024 Biogen reports strong second quarter 2024 results and raises full year 2024 financial guidance; Second quarter 2024 total revenue of $2.5 billion, GAAP diluted EPS of $4.00 and Non-GAAP diluted EPS of $5.28 Second quarter total revenue was flat at actual currency and up 1% at constant currency, with GAAP diluted EPS decline of 2% and Non-GAAP diluted EPS increase of 31% year-over-year • Core pharmaceutical revenue (product revenue + LEQEMBI) up 5% at actual curr ...

Alcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF). The first stage of the pivotal IDE PIERRE trial has been completed. 10 spinal muscular atrophy (SMA) patients have undergone ThecaFlex implantation and have received nusinersen through the device. No device-related adverse events, including infections, were observed in the 30 days after implantation. FDA has agreed to an additional 80-SMA patient ...

Industry Overview - The second-quarter 2024 reporting cycle for the Medical sector, which includes pharma/biotech and medical device companies, is gaining traction with several key companies reporting strong results [1] - As of July 24, 16.9% of companies in the Medical sector, representing 33.8% of the sector's market capitalization, reported quarterly earnings, with 100% outperforming both earnings and revenue estimates [1] - Year-over-year earnings for the Medical sector are expected to increase by 19.4%, while sales are projected to grow by 7.3% [1] Company Performance GSK plc - GSK has a solid track record, surpassing estimates in three of the last four quarters, with an average earnings surprise of 10.11% [3] - The Zacks Consensus Estimate for GSK's earnings per share is $1, driven by higher sales of newer products, which are expected to offset declines in older drug sales [4] Vertex Pharmaceuticals - Vertex has consistently beaten earnings estimates in the last four quarters, with an average surprise of 5.92% [5] - The Zacks Consensus Estimate for Vertex's revenues is $2.65 billion, with earnings estimated at $4.04 per share, driven by strong sales of its cystic fibrosis drug, Trikafta/Kaftrio [5] Biogen - Biogen has beaten earnings estimates in three of the last four quarters, with an average surprise of 3.91% [6] - The Zacks Consensus Estimate for Biogen's revenues is $2.38 billion, with earnings pegged at $4.00 per share, although sales are likely to be impacted by lower sales of multiple sclerosis drugs [7] Moderna - Moderna has exceeded earnings estimates in each of the last four quarters, with an average surprise of 55.39% [8] - The Zacks Consensus Estimate for Moderna's sales is $124.9 million, with an expected loss of $3.47 per share, as COVID-19 vaccine sales are anticipated to be minimal [8] Regeneron Pharmaceuticals - Regeneron has beaten earnings estimates in three of the last four quarters, with an average surprise of 4.47% [9] - The Zacks Consensus Estimate for Regeneron's revenues is $3.38 billion, with earnings estimated at $10.55 per share, driven by strong sales of the asthma drug Dupixent [9]

Wall Street analysts forecast that Biogen Inc. (BIIB) will report quarterly earnings of $4 per share in its upcoming release, pointing to a year-over-year decline of 0.5%. It is anticipated that revenues will amount to $2.38 billion, exhibiting a decline of 3.1% compared to the year-ago quarter.The consensus EPS estimate for the quarter has been revised 0.3% lower over the last 30 days to the current level. This reflects how the analysts covering the stock have collectively reevaluated their initial estimat ...

The collaboration aims to identify and develop accessible, minimally invasive blood-based biomarkers specific for tau pathology in the brainThese tools have the potential to be used to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer’s disease CAMBRIDGE, Mass. and BREA, Calif. and TOKYO, July 30, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to potentially identif ...

Core Insights - Biogen, Beckman Coulter, and Fujirebio have announced a collaboration to develop blood-based biomarkers for tau pathology in Alzheimer's disease, aiming to enhance patient stratification and treatment monitoring [1][2][3] Company Summaries Biogen - Founded in 1978, Biogen is a leading biotechnology company focused on innovative science to deliver new medicines and create value for shareholders and communities [4] - The company will provide Alzheimer's clinical study data and expertise in biomarker research to prioritize markers for tau pathology in the collaboration [3] Beckman Coulter - Beckman Coulter has over 80 years of experience in advanced diagnostics, aiming to improve patient health through innovative diagnostic solutions [5][6] - The company will be responsible for diagnostic development, manufacturing, and commercialization in the collaboration [3] Fujirebio - Fujirebio, part of H.U. Group Holdings Inc., has over 50 years of experience in in vitro diagnostics and aims to develop novel neurodegenerative disease diagnostics [7] - The company will collaborate to accelerate the development of blood-based biomarkers for tau pathology and deliver them globally [3]

Core Viewpoint - Biogen faces a significant setback as the European Medicines Agency's CHMP issued a negative opinion on the marketing approval for its Alzheimer's therapy, Leqembi, due to safety concerns related to brain swelling [1] Financial Performance - Biogen's stock has declined 18.4% year-to-date, contrasting with a 0.5% increase in the industry [2] - The company experienced a negative earnings surprise of 6.38% in the last reported quarter [2] Sales and Revenue Insights - Sales of Biogen's multiple sclerosis drugs, Tecfidera and Tysabri, are expected to decline due to increased competition and the introduction of generic versions [3] - The Zacks Consensus Estimate for Tecfidera sales is $236 million, while the estimate for Tysabri is $420 million [3] - Sales of Vumerity, another MS drug, are anticipated to rise, with estimates at $154 million [3] - Spinraza's sales growth is expected to be impacted by competition and shipment timing, with estimates at $403 million [5] - Sales of the newly launched rare disease drug Skyclarys are expected to improve from the first quarter [5] - Contract manufacturing and royalty revenues are projected to decline, including Biogen's share from the collaboration with Eisai for Leqembi [6] Product Developments - Leqembi has been launched in the U.S., Japan, and China, with recent approvals in Israel, Hong Kong, and South Korea [1] - The European Commission granted marketing approval to Qalsody for treating ALS in Europe, with encouraging launch uptake in the U.S. [7] Cost Management - Lower cost of sales and operating costs due to cost-saving initiatives are expected to positively impact profits [7] Earnings Expectations - Biogen's Earnings ESP is -1.09%, indicating a lower likelihood of an earnings beat compared to the Zacks Consensus Estimate of $4.00 [9]

Biogen stock has slipped 18% so far this year.Biogen (BIIB -7.15%) built itself into a multiple sclerosis (MS) treatment giant over the years -- but as older blockbusters lost exclusivity, growth stalled. And last year, annual revenue dropped more than 45% to $9.8 billion from its peak back in 2019. Though Biogen launched a new MS drug back in 2019, called Vumerity, it's failed to replicate the growth and revenue levels of its predecessor.To boost growth, Biogen turned to other areas, and has placed a parti ...

European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai, creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. The European Commission, the EU's executive body, has a final say in Leqembi's approval. But it almost always follows the drug regulator's recommendations. In a statement, Eisai said it is "extremely disappointed" by the regulator's negative recommendation. The company added that it will seek a re-examinatio ...