Zinger Key Points
- Biogen is set to report Q4 earnings on Feb. 12, with analysts expecting EPS of $3.35 and revenue of $2.40B. FY24 EPS is projected at $16.34.
- The FDA approved maintenance dosing regimen for Leqembi in Alzheimer's, while Biogen's nusinersen higher-dose regimen is under review.
- Get two weeks of free access to pro-level trading tools, including news alerts, scanners, and real-time market insights.
Biotech giant Biogen Inc BIIB is scheduled to report fourth-quarter earnings on 12 February.
The Wall Street forecasts fourth-quarter adjusted EPS of $3.35 and sales of $2.40 billion, while fiscal year 2024 adjusted EPS is expected to be $16.34 and sales of $9.64 billion.
January 2025 had been an eventful month for Biogen. Sage Therapeutics, Inc. SAGE announced that its Board of Directors initiated a process to explore strategic alternatives and rejected the unsolicited, nonbinding proposal it received from Biogen for $7.22 per share.
In January, the FDA approved the Supplemental marketing application for lecanemab-irmb (Leqembi) intravenous (IV) maintenance dosing once every four weeks.
Leqembi is indicated for Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.
The FDA and the European Medicines Agency accepted to review supplemental marketing applications seeking approval for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA).
The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and a higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusinersen regimen (Spinraza).
The European Commission asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024, whether this may require an update of the opinion, and whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.
Investors are focused on Biogen's growth strategies. This includes expanding its pipeline, pursuing external business development, or leveraging new opportunities to counter declining revenue in the latter half of the decade.
In December, Jefferies downgraded Biogen, citing the company's tough setup.
Leqembi (lecanemab) sales growth remains sluggish, falling below consensus projections through 2030.
Challenges like PET scan reimbursement, slow protocol updates at major hospital networks, and identifying eligible patients continue to hinder adoption.
Price Action: BIIB stock is down 2.61% at $138.81 at the last check on Tuesday.
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