Note: All changes are versus the prior-year period unless otherwise stated
"In the second quarter, Biogen continued to deliver strong financial results," remarked CEO Michel Vounatsos, noting that the company completed its much-anticipated FDA submission for aducanumab as a potential Alzhiemer's disease therapy (see ViewPoints: Clock is officially ticking on aducanumab). Regarding whether the filing will receive priority review, chief medical officer Alfred Sandrock said "we do have a voucher (to gain priority review). We received one when we got nusinersen (Spinraza) approved, but we haven't commented on how we're going to use it, when we're going to use it."
During the earnings call, which coincided with the announcement of the departure of chief financial officer Jeffrey Capello, Biogen explained that while first-quarter product revenues benefitted by approximately $100 million in accelerated sales tied to the COVID-19 pandemic, primarily in Europe, around $75 million of this was utilised in the second quarter.
Biogen said that it now expects full-year revenue in the range of $13.8 billion to $14.2 billion, down from a prior estimate of between $14 billion and $14.3 billion. Meanwhile, annual earnings per share are forecast to be in the range of $34 to $36, lifted from an earlier prediction of between $31.50 and $33.50. Analysts expect revenue in 2020 of $13.9 billion, on earnings of $33.07 per share.
The company noted that its financial guidance does not include any operational impact from the potential entry of generic versions of Tecfidera in the US this year. In June, Biogen lost a patent dispute with Mylan over the multiple sclerosis drug, and while it plans to appeal, analysts have said the ruling opens the door to generic competition in the US.
"After the recent Tecfidera intellectual property loss and the delay in aducanumab filing relative to expectations, investors like the beat-and-raise quarter," remarked SVB Leerink analyst Marc Goodman.
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