Analysts dialed in to Biogen's earnings call Thursday hoping to hear something, anything, about the company's plans to have the first ever drug for the underlying cause of Alzheimer's disease. Instead, they were mostly met with radio silence.
For context: Biogen's treatment, known as aducanumab, looked as though it failed a pair of large clinical trials last year. Such results could have shelved the drug, except that after further analysis, Biogen claimed it actually succeeded in one trial while showing some encouraging effects in the other. Based on these data, the company said it would file an application with the Food and Drug Administration in early 2020 to get aducanumab approved.
Biogen was pressed for more granularity about when exactly that filing will come, but company leaders provided few details on Thursday's call other than saying they are working to complete the process "as soon as possible." Executives also didn't answer an analyst question on whether they expect aducanumab will receive a type of expedited FDA assessment called priority review.
"It's basically a matter of putting together the documentation," said Al Sandrock, Biogen's head of research and development.
With no major filing updates to chew on, analysts keyed in to a Biogen forecast that about a fifth of total revenue this year will go toward selling, general and administrative expenses. That would amount to between $2.7 billion and $2.9 billion, which reflects roughly $400 million to $600 million for aducanumab marketing that's "baked into guidance," wrote Evercore ISI analyst Umer Raffat.
The focus on aducanumab is understandable, as investors attribute a substantial portion of Biogen's value to its success. Yet the drug could also be distracting from problems in other parts of the business.
Spinraza, the company's blockbuster treatment for spinal muscular atrophy, has a new competitor in Novartis' Zolgensma.
Biogen is noticing the impact of the gene therapy in the treatment of pediatric patients, which represent about 5% of the SMA population, according to Chief Financial Officer Jeff Capello. Though the number of new patients on Spinraza increased 2% between the third and fourth quarter, Capello said more than half of the new starts were adults, and that growth in the adult segment exceeded overall growth.
That report comes on the heels of Novartis' fourth quarter earnings, which showed $186 million in Zolgensma sales as another 100 infants were given the therapy from October through December.
Biogen expects another competitor, an oral SMA drug from Roche, to enter the market this year.
Meanwhile, Biogen's top-selling drug Tecfidera faces patent challenges.
The most immediate comes from Mylan, with a decision from an inter partes review expected by the end of the first week of February. If the review rules against Biogen, the company intends to appeal — a process that, according to Capello, typically takes 12 to 18 months.
In 2019, Tecfidera accounted for $4.4 billion of Biogen's $11.4 billion in product revenue.
Michael Yee of investment bank Jefferies predicts that, depending on three upcoming events, including the IPR review for Tecfidera and the priority review classification for aducanumab, Biogen's share price could go as high as $352 or as low as $229.
Biogen shares were down 1% in late morning trading Thursday.