Biogen recorded $1 million in revenue from its new treatment for Alzheimer's disease in the last quarter of 2021, offering the latest evidence that the drug, which came to market with multi-billion dollar sales expectations, continues to struggle commercially.
Biogen has been banking on the drug, called Aduhelm, to offset declines elsewhere in its business. But so far, Aduhelm has generated meager sales because of persistent doubts from doctors and some medical centers about the drug's effectiveness, combined with a high price tag that some insurers rejected.
Amid these and other challenges, Biogen said recently it plans to lower expenses by half a billion dollars. On Thursday, while presenting its latest earnings report, Biogen warned again that if the company's outlook doesn't improve in a few months' time executives are prepared for further cost-cutting measures.
Biogen expects the bulk of its currently planned cost cuts — about $350 million — to take place this year. The savings could come from a "downsizing" of Biogen's infrastructure supporting its work in Alzheimer's disease, or from other initiatives, the company said.
Shares in Biogen slid by 5.5% in early morning trading Thursday, before gaining back some of those losses to trade down 2.5%.
Last June, Aduhelm became the first drug approved in the U.S. for what many believe to be the underlying cause of Alzheimer's. With few treatment options for the disease and an estimated 6 million patients in the U.S. alone, it was expected by both Biogen and a string of Wall Street analysts that Aduhelm sales would grow quickly once the drug hit the market.
That hasn't happened. After the drug's launch faltered in the fall and winter, analysts dramatically scaled back their forecasts for Aduhelm sales. Even so, the $1 million figure for Aduhelm still came in lower than consensus expectations.
And while Biogen has tried to address the concerns surrounding its drug, the company encountered a significant setback last month when Medicare proposed a highly restrictive coverage policy for Aduhelm and other similar Alzheimer's drugs. Medicare, as the government insurance program for people aged 65 and older, is responsible for many of the patients most likely to receive Aduhelm and is viewed as a tone-setter for other large insurance providers.
The Centers for Medicare and Medicaid Services, which operates Medicare, intends to finalize the policy by April. Biogen said that if coverage remains equally restrictive, it would warrant added measures to reduce expenses.
"We have to protect the company's [earnings per share] and bottom line, and we will take additional measures," CEO Michel Vounatsos told investors last month on a conference call discussing the draft Medicare policy.
As for what those measures may look like, STAT News recently reported that Biogen is gearing up for its largest round of layoffs in years, with more than 1,000 jobs potentially on the line. The last major headcount reduction at the company happened in 2015, when it eliminated 11% of its then-workforce of about 7,600. Notably, those layoffs came right around the time the first patient was enrolled in the clinical trial program that ultimately led to Aduhelm’s approval.
Biogen recorded just shy of $11 billion in revenue last year, down 18% from its 2020 total. Executives currently expect between $9.7 billion and $10 billion in sales in 2022, which would represent a third straight year of declines. While that estimate already assumes minimal sales of Aduhelm, the company noted that a restrictive Medicare policy could negatively affect its guidance further.
Against the sputtering launch of Aduhelm and market challenges to its top-selling drugs, Biogen has come under intensified pressure from investors to search externally for growth. On that front, the company is "constantly looking at options," according to Chief Financial Officer Michael McDonnell.
McDonnell said on Thursday's earnings call that Biogen is open to deals "of all sizes," including those that would involve drugs in the early- and late-stages of human testing. And while interested in various opportunities, McDonnell added that the company's primary focus remains neuroscience.
Biogen had $4.7 billion in cash and equivalents by the end of last year, and is poised to receive an additional infusion of more than $2 billion through the recently announced sale of a joint venture with Samsung's biotechnology division. Analysts at Mizuho Securities estimate Biogen has around $10 billion to $11 billion in total purchasing power.
Note: This story has been updated to include additional information on Biogen's forecasts for 2022, and executive commentary from the company's fourth quarter earnings call.