Biogen expects “minimal” sales this year from its Alzheimer’s treatment initially hailed as a potential breakthrough drug, but one with an eye-popping price that drew immediate criticism.
The drugmaker on Thursday released a 2022 forecast that caught investors off guard, sending shares sliding.
Biogen's Alzheimer’s treatment brought in only $3 million last year following its debut, but the company, based in Cambridge, Massachusetts, also reported eroding sales from other key products.
Aduhelm entered the U.S. market after federal regulators approved it last June, but it received pushback from doctors and patient advocates over its initial price of more than $50,000 annually, not counting insurance coverage.
Aduhelm, the first new Alzheimer’s treatment in years, clears brain plaque thought to play a role in the disease’s development. Regulators approved it based on study results showing the drug seemed likely to benefit patients. But they’ve asked for more research, and Biogen will soon start another clinical study.
Several prominent medical centers around the country declined to offer it, and Biogen was forced to slash the price late last year.
Then the federal government proposed restrictions last month for a key population, Medicare patients.
The Centers for Medicare and Medicaid Services said in a preliminary coverage decision that patients taking Aduhelm will have to participate in another study that evaluates the drug’s effectiveness in order for Medicare to cover the cost.
The government is expected to make its final coverage decision in April after receiving comments and feedback on the preliminary plan. That decision will apply to all drugs in Aduhelm's class, not just the Biogen treatment.
Biogen CEO Michel Vountasos said Thursday that the preliminary coverage decision would be “prohibitive,” and it would make it harder to diversify the patient population.
He said it also would duplicate what Biogen, which developed Aduhelm with Japan’s Eisai Co., is already doing to collect more data on its drug.
But company officials say they are meeting with regulators and plan to submit comments soon.
Aduhelm sales of $1 million in the fourth quarter remained “incredibly light," Mizuho Securities analyst Salim Syed said in a research note.
He and other analysts expect the Medicare coverage decision, if it stands, to crush Aduhelm’s future sales as well.
Biogen reported a better-than-expected fourth quarter on Thursday but fell short of average forecasts for 2022.
The company expects annual adjusted per-share earnings of between $14.25 and $16 on revenue ranging from $9.7 billion to $10 billion.
Analysts forecast, on average, earnings of $18.76 per share on $10.32 billion in revenue for 2022, according to FactSet.
The company also is factoring in a continued decline in sales for the multiple sclerosis treatment Tecfidera in the U.S. due to cheaper, generic competition.
That drug brought in $1.95 billion in sales last year, a nearly 50% drop from 2020.
Shares of Biogen Inc. fell more than 4%, or $10.37, to $214.59 Thursday morning, while broader indexes also dropped.
That stock price has now shed nearly $200 in value since Aduhelm was approved.
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