The next time Biogen reports its quarterly earnings, the world should know whether its controversial Alzheimer's drug aducanumab sports an FDA approval or whether the company is back at the drawing board. For now, the company says it's preparing for the drug’s rollout in the U.S. despite concerns from all sides about its prospects—and as its U.S. sales plunge.
Biogen is ready to immediately launch aducanumab in more than 600 clinical sites in the U.S. if given the FDA’s go ahead in June, with “many more” sites in the works, CEO Michel Vounatsos told analysts on an earnings call Thursday.
In fact, the company expects strong demand for aducanumab out the gate. It's been working “to evaluate the capacity of these and other sites to absorb an influx of Alzheimer’s patients,” Vounatsos said.
“We know that the availability of specialists and diagnostics capabilities are a bottleneck, so we have to prepare the sites of care,” Vounatsos told analysts.
As pharma watchers know, aducanumab’s fate at the FDA will be pivotal for Biogen, which is facing competitive pressures for its other blockbuster medicines, like Spinraza, the company’s spinal muscular atrophy drug, and its multiple sclerosis drug Tecfidera.
First-quarter U.S. sales of Spinraza plunged nearly 37% compared with the same period last year to roughly $149 million. Spinraza has faced growing competition from alternative treatments in the U.S, including Roche’s oral option Evrysdi and Novartis's gene therapy Zolgensma.
The COVID-19 pandemic has also continued to hamper Spinraza’s performance, Vounatsos said on the call, although he was pleased with how the drug performed in markets abroad. Spinraza’s global sales outside the U.S. grew by more than 12% to nearly $330 million in the first quarter.
Similarly, Tecfidera’s U.S. sales plummeted 79% during the first quarter compared with last year to $162.4 million. Biogen’s MS drug continues to take a tremendous hit from generic competition.
In all, Biogen's U.S. sales fell to $900 million in the first quarter, down from $1.58 billion during the same period in 2019.
Biogen’s finance chief Michael McDonnell reiterated that the company’s forecasted guidance for 2021 hinges on the FDA’s decision on aducanumab. Even if the Alzheimer's drug is given the agency’s OK, a chance that seems less likely than a coin flip to some analysts, it won't serve as a cash cow for Biogen immediately, he warned.
“If aducanumab is approved in the U.S., we would expect an immediate launch. However, dose titration will result in less revenue per patient in the initial months of treatment,” McDonnell said, adding that Biogen would expect only “modest revenue” for the drug in 2021 as a result.
It’s still unclear if the company will ever get to that point. A key FDA advisory panel voted against aducanumab in November, and advisers on the panel have since doubled down on their objections to the drug. The FDA has spent an additional three months following the panel's recommendation examining aducanumab’s data before issuing its final decision, which is scheduled for early June
To Vounatsos, the extra three months the FDA has spent reviewing aducanumab actually came to the company’s benefit. The agency’s additional review has been “a gift for the team,” allowing it to prepare for the drug’s deployment because Biogen can “never fully ready for such a launch,” he said.