RESEARCH TRIANGLE PARK – Biogen expects “minimal” revenue this year from its Alzheimer’s treatment initially hailed as potentially a breakthrough drug, but one with an eye-popping price tag that drew immediate criticism from doctors and patient advocates.

The drugmaker [which has a big campus in Research Triangle Park] on Thursday released a forecast for 2022 that caught investors off guard, sending shares down more than 3% before the opening bell.

For 2022, Biogen expects adjusted per-share earnings of between $14.25 and $16 on revenue ranging from $9.7 billion to $10 billion.

For 2022, analysts expect, on average, earnings of $18.76 per share on $10.32 billion in revenue, according to FactSet.

Shares of Biogen Inc. later fell $6.97 to $217.99.

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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 over its initial price of more than $50,000 annually.

“Biogen continued to execute well in the fourth quarter despite the challenges we have faced,” said Michel Vounatsos, Biogen’s Chief Executive Officer, in a statement. “We have introduced the first FDA approved treatment for Alzheimer’s disease in nearly 20 years, and we are engaging with the Centers for Medicare and Medicaid Services with the hope of finding a path for immediate
patient access.”

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.

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 clinical trial that evaluates the drug’s effectiveness in order for Medicare to cover the cost.

The government will make a final overage decision this spring.

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Vountasos has said that decision, if finalized, “would deny nearly all Medicare beneficiaries” access to the treatment.

“Our guidance assumptions are highly dependent on the final National Coverage Determination (NCD) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, which is currently uncertain. If the final NCD is not broader than the proposed NCD, our anticipated results and guidance may be impacted,” Biogen explained.

The company also is factoring in a continued decline in sales for the the multiple sclerosis treatment Tecfidera in the U.S. due to cheaper, generic competition.

Read the full earnings report online: