Thanks to competitive pressures for its top-sellers, Biogen's sales were on the slide before its controversial FDA approval for Alzheimer's drug Aduhelm. It turns out the drug won't bring a quick financial lift like investors had hoped.
On Wednesday morning, investors learned just how slow the launch has been as Biogen revealed (PDF) a stunning number—$300,000 in third-quarter sales for the drug once hailed as a first-of-its-kind breakthrough. The paltry figure didn’t approach the analyst consensus of $14 million.
“We are obviously disappointed with the delayed uptake of Aduhelm in the U.S.,” Biogen CEO Michel Vounatsos said on a conference call. “The healthcare system remains a major bottleneck. In particular, the lack of clarity on reimbursement has delayed patient access.”
Steeped in controversy since its June approval and saddled with a much-criticized price of $56,000 per year, the fate of Aduhelm appears dependent on whether Medicare will provide coverage for the drug and for others in its class of monoclonal antibodies that target amyloid plaque buildup. That process is due to complete in April 2022.
“We have not heard that price is the primary driver for any decision to treat patients,” Alisha Alaimo, Biogen’s president of U.S. organization said on the call.
Alaimo expressed optimism about the Medicare decision, pointing out that 10 of the 12 FDA approved drugs that have faced the NCD process have been cleared for Medicare coverage. But even with a positive decision there, Biogen doesn’t expect uptake to be quick.
“I don’t expect the effect to be explosive,” Vounatsos said. “We believe there will be an acceleration, non-linear, of the uptake because the patient journey is still long.”
Analysts reacted with surprise to the sales figure for Aduhelm but believe much can change with a positive Medicare decision. The drug still carries a $9 billion peak sales consensus estimate, Mizuho's Salim Sayed pointed out. He warned investors not to fixate on the “minimal Aduhelm revenue of 2021,” but to consider its “long-term prospects.”
“Setup still is very reasonable for 2022, given sentiment is so negative,” Jefferies' Michael Yee wrote in his own note.
Would Biogen consider abandoning Aduhelm for its promising pipeline treatment lecanemab, an Eisai-partnered drug also for Alzheimer’s patients?
“We are delighted to see lecanemab coming along, but it’s only phase 2,” Vounatsos said. “We have the luxury of having two assets. Importantly, I want to reiterate that we stand behind the data for Aduhelm. We know the data. We see the data. We see the new data.”
Aside from Aduhelm, sales for Biogen’s other treatments declined by double digit percentages during the period. Total revenue for the period came in at $2.78 billion, an 18% decrease from the same period last year.
Multiple sclerosis med Tecfidera posted $498 million in third-quarter sales, a 48% decrease from the same period last year. Spinraza, a spinal muscular atrophy treatment, generated $444 million, a 10% decrease.