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 The U.S. Centers for Medicaid and Medicare Services (CMS) in January
proposed
https://www.reuters.com/
business/healthcare-pharmaceuticals/future-biogens-aduhelm-hinges-us-medicare-alzheimers-coverage-2022-01-11/#:~:text=Jan%2011%20(Reuters)%20-%20The,treatment%20more%20than%20many%20expected
to severely restrict coverage for Alzheimer's drugs, including
Biogen's Aduhelm, only to patients taking part in approved clinical
trials. A final decision is expected in April.
Chief Financial Officer Michael McDonnell said the company was
"constantly looking at options around deals of all sizes," including
drugs in early- and late-stage development, "primarily focused on
neuroscience."
Mizuho analyst Salim Syed said investors will be looking for the
company to make some business development moves.
"When your back is against the wall, as a company, your base
business is in decline, and investors don't believe in the pipeline
that you have, M&A becomes much more important," he said. "How
transformative of a deal should we or could we expect in 2022?
That's the question."
Biogen had already met with CMS to present its views on the
regulator's proposal to limit patient access. Chief Executive Michel
Vounatsos said Biogen would advocate for a final decision that would
provide coverage to the much larger group that was tested in the
company's clinical trials.
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 The company warned that it
could be forced to cut more costs, beyond the
current program to save $500 million annually,
if the final coverage decision is not broader
than the proposal.
"We will take aggressive steps should the ...
(coverage proposal) remain in its current form,"
Vounatsos said.
The decision on Aduhelm, once touted as a
potential multibillion-dollar drug, comes at a
pivotal time for the company, with sales of its
multiple sclerosis drug Tecfidera under pressure
from generic competition.
Biogen on Thursday forecast full-year adjusted
profit of $14.25 to $16.00 per share, well short
of analysts' estimates of $18.82 per share,
according to Refinitiv IBES.
Aduhelm brought in $1 million in sales in the
fourth quarter, compared to already diminished
estimates of $2.8 million.
Biogen's shares were off by about 1% at $222.36.
(Reporting by Manas Mishra in Bengaluru; Editing
by Saumyadeb Chakrabarty and Bill Berkrot)
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