New York, November 09, 2020 -- Moody's Investors Service ("Moody's") placed the
Baa1 ratings of Biogen Inc. ("Biogen") under review for downgrade.
This action follows a recent FDA advisory panel meeting on Biogen's
experimental drug aducanumab.
The panel found that the results of Biogen's clinical trials do
not support the approval of aducanumab for the treatment of Alzheimer's
disease. The FDA's target date to act on the aducanumab application
is March 7, 2021. The FDA is not bound by the findings of
the advisory panel. However, Moody's believes that
the panel's findings significantly reduce the likelihood of an approval.
This setback comes on the heels of recent US generic competition for Tecfidera,
Biogen's largest product, further elevating the credit risk
profile.
Ratings placed under review for downgrade:
Senior unsecured notes, Baa1
Senior unsecured shelf, (P)Baa1
Outlook actions:
Outlook changed to ratings under review from negative
RATINGS RATIONALE / FACTORS THAT COULD LEAD TO AN UPGRADE OR DOWNGRADE
OF THE RATINGS
Biogen's Baa1 rating (under review for downgrade) reflects its good competitive
position in the pharmaceutical industry with over $10 billion of
revenue and a strategic focus on neuroscience. This includes a
solid position in multiple sclerosis (MS), supported by a broad
product portfolio spanning oral drugs, injectables, and infused
products. It also reflects the substantial market opportunity Biogen
has in aducanumab, currently undergoing regulatory review as a potential
treatment for Alzheimer's disease, notwithstanding the recent FDA
advisory panel.
These strengths are tempered by rising competitive pressures in MS and
other areas, as well as earnings pressure related to generic Tecfidera.
With US Tecfidera sales representing about 25% of Biogen's total
revenue prior to generics, the impact on earnings and cash flow
will be even higher due to fixed costs. These pressures are compounded
by ongoing erosion in Rituxan due to biosimilars, and rising competition
for Spinraza in spinal muscular atrophy. As a result, Moody's
estimates that debt/EBITDA will rise to about 2.0x in 2021.
Biogen's cash flow will also be materially impacted, with free cash
flow declining from $6.4 billion as of the LTM period ending
June 30, 2020 to around $3 billion in 2021.
The rating review will focus on the FDA decision on aducanumab,
including anticipated next steps in the development of the product if
it is not approved. The review will consider Biogen's strong position
and strategic focus in the neuroscience market, its other pipeline
opportunities and its financial policies which to date have supported
very low financial leverage. The review will also consider strategic
actions, if any, that Biogen decides to take in response to
a potential non-approval of aducanumab.
ESG considerations are material to the rating. Moody's regards
the coronavirus pandemic as a social risk under Moody's ESG framework,
given the substantial implications for public health and safety.
Beyond the coronavirus outbreak, other social risks include exposure
to regulatory and legislative efforts aimed at reducing drug prices.
These are fueled in part by demographic and societal trends that are pressuring
government budgets because of rising healthcare spending. The multiple
sclerosis category is one that has received significant attention for
price increases. Potential changes to drug pricing regulations
also contribute to uncertainty around the ultimate sales potential for
a product like aducanumab, if approved. With respect to governance
considerations, Biogen has maintained very conservative financial
policies with low financial leverage.
Headquartered in Cambridge, Massachusetts, Biogen, Inc.
is a global biopharmaceutical company with principal expertise in neurodegenerative
diseases and autoimmune disorders including multiple sclerosis.
The principal methodology used in these ratings was Pharmaceutical Industry
published in June 2017 and available at https://www.moodys.com/researchdocumentcontentpage.aspx?docid=PBC_1062755.
Alternatively, please see the Rating Methodologies page on www.moodys.com
for a copy of this methodology.
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Michael Levesque, CFA
Senior Vice President
Corporate Finance Group
Moody's Investors Service, Inc.
250 Greenwich Street
New York, NY 10007
U.S.A.
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Jessica Gladstone, CFA
Associate Managing Director
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JOURNALISTS: 1 212 553 0376
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