Biogen expects new Alzheimer’s drug to weigh on 2023 outlook
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Biogen (NASDAQ:BIIB) announced better-than-expected Q4 2022 results and in-line guidance on Wednesday, noting that the market launch of its newly approved Alzheimer's medication Leqembi (lecanemab), could hurt its 2023 outlook.
In January, Biogen (BIIB) added lecanemab to its Alzheimer's franchise, previously led by Aduhelm, when the FDA greenlighted the anti-amyloid antibody developed with the company's Japanese partner Eisai (OTCPK:ESALF) (OTCPK:ESALY).
However, Aduhelm sales for the quarter came below Street forecasts at $0.3M amid restrictions on Medicare coverage and concerns over efficacy.
For 2023, the company estimates modest in-market revenue for lecanemab, with commercialization costs expected to offset the revenue, and projects a mid-single-digit revenue decline for the year compared to the ~7% YoY drop forecasted by analysts.
Biogen's (BIIB) per share earnings guidance of $15.00 â $16.00 on an adjusted basis stands in line with $15.76 in the consensus.
Christopher Viehbacher, in his first conference call as Biogen's (BIIB) CEO, highlighted the challenges for lecanemab rollout in the U.S.
"There's going to be an awful lot of education of physicians around safety, around the diagnosis and the infrastructure has to expand to be able to provide the PET scans or the CSF testing," he said.
Viehbacher also noted the importance of depression therapy Zuranolone for the company's prospects.
In February, Biogen (BIIB) and partner Sage Therapeutics (SAGE) announced that the FDA accepted their New Drug Application (NDA) for the oral depression therapy under the agency's priority review with an action date on Aug. 05.
In terms of revenue, the company reported $2.5B for the quarter and $10.1B for 2022, indicating a ~7% YoY drop, as its multiple sclerosis franchise added ~$1.3B and $5.4B revenue indicating ~17% YoY and ~11% YoY decline.
Revenue from spinal muscular atrophy therapy Spinraza stood at $458.8M with ~4% YoY growth in Q4 ahead of expectations, while its full-year revenue fell ~6% YoY to $1.8B.
Meanwhile, less-than-expected Aduhelm sales weighed on cost of sale with $286M charges related to write-offs of inventory and purchase commitments in excess of demand.
However, the company's bottom line improved ~50% YoY to $550.4M, driven by a $195.4M gain from fair value remeasurement.
Read: Despite FDA approval of lecanemab, Seeking Alpha contributor Lane Simonian thinks that long-term pressure on shares of Biogen (BIIB) and partner Eisai (OTCPK:ESALY) could outweigh the long-term positives.