Analysts and investors are divided over whether Biogen will win approval for a new Alzheimer’s drug.
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The biotech Biogen earned more than expected in the latest quarter, raised its financial forecasts, and disclosed figures showing sales of two key drugs weren’t as bad as expected.
Biogen reported non-GAAP diluted earnings of $5.34 per share early Thursday, beating the FactSet consensus estimate of $4.97. The company slightly increased its earnings guidance for the full 2021 fiscal year, saying it now expected between $17.50 and $19 in non-GAAP diluted earnings per share, up from between $17 and $18.50.
The company offered no updates on the U.S. Food and Drug Administration’s continuing review of its Alzheimer’s disease therapy aducanumab, though the process will likely be a focus of analyst questions on an investor call scheduled for 8 a.m. Eastern on Thursday.
Meanwhile, erosion in sales of two troubled top-selling Biogen drugs wasn’t as bad as analysts had expected. The stock climbed 1.4% shortly after the financial results were announced early Thursday, after falling 1.2% on Wednesday.
Sales of Tecfidera, the top-selling Biogen (ticker: BIIB) multiple sclerosis therapy now facing unexpectedly early generic competition, were $479.3 million for the quarter. That slightly beat the FactSet consensus estimate of $467 million, but was down from $1.1 billion for the same quarter last year.
And sales of Spinraza, the spinal muscular atrophy drug that is also facing substantial competition, were $520.5 million, beating the consensus estimate of $482 million, but down from the $565 million the company sold in the same quarter last year.
Biogen shares are up 10.2% so far this year, and down 7.7% over the past 12 months. The U.S. Food and Drug Administration is scheduled to announce by June 7 whether it will approve aducanumab, after delaying its decision earlier this year.
In a note out soon after the release was published, Jefferies analyst Michael Yee noted that the company has said it was ready to launch aducanumab upon FDA approval, and that there are more than 600 sites ready to treat patients with the therapy. “[Biogen management] continues to prepare for and make public optimistic comments around the [potential] approval of [aducanumab],” he wrote.
Yee, who rates the stock a Buy, wrote earlier this week that the stock could climb 66% if aducanumab is approved, or drop 30% if it is rejected.
“Our first quarter 2021 results were consistent with our expectations across [multiple sclerosis], [spinal muscular atrophy], and biosimilars despite increased competition,” said the company’s CEO, Michel Vounatsos. “We are pleased with our operational performance during the quarter, and we are increasing our earnings guidance for the full year.”
Biogen said that its financial guidance continues to assume that the FDA will approve aducanumab by June 7. Not all investors are so sure.
Aducanumab’s quest for regulatory approval has been rocky, with an FDA advisory panel late last year saying that the drug’s efficacy had not been proven. The debate over whether the drug will be approved is one of biotech’s most closely watched, with investors and analysts split.
Investors will be listening closely on the earnings call for any clues executives may divulge regarding aducanumab’s progress with the FDA.
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