|[February 06, 2013]
Biogen Idec to Acquire Full Rights and Control of TYSABRI® from Elan for Upfront Cash and Contingent Payments
WESTON, Mass. --(Business Wire)--
Biogen Idec Inc. (NASDAQ: BIIB) today announced the company has agreed
to purchase Elan's interest in TYSABRI (natalizumab) and upon closing
will gain full strategic, commercial and decision-making rights to
TYSABRI. Upon the closing of the transaction, the previous collaboration
agreement between the companies, whereby worldwide TYSABRI profits were
split 50/50, will be terminated along with the agreement's change of
Under the terms of the agreement, Biogen Idec will use its existing cash
reserves to make a payment of $3.25 billion to Elan upon the closing of
the transaction and make future contingent payments to Elan in an amount
equal to 12% of global net sales of TYSABRI for the first twelve months,
and thereafter, Biogen Idec will continue to make contingent payments of
18% on annual global net sales of TYSABRI up to $2.0 billion and 25% on
annual global net sales that exceed $2.0 billion. In 2014 only, the $2.0
billion threshold will be pro-rated for the portion of 2014 remaining
after the first 12 months expires.
Biogen Idec anticipates the transaction will be approximately $0.20 to
$0.30 accretive to 2013 GAAP earnings per share and $0.50 to $0.60
accretive to non-GAAP earnings per share, and will continue to be
accretive thereafter, depending on the sales trajectory of TYSABRI.
"This is a natural next step for Biogen Idec and TYSABRI, and it
underscores our deep, long-term commitment to improving the lives of MS
patients around the world," said George A. Scangos, Ph.D., chief
executive officer of Biogen Idec. "TYSABRI is a remarkably efficacious
drug, and with the increased awareness of our risk stratification
capabilities, we believe MS patients' use of TYSABRI will continue to
expand over the long-term. Full ownership will improve our ability to
navigate its role as part of our leadership in MS. We appreciate Elan's
tremendous partnership and the productive approach to our discussions
that led to a transaction that benefits the shareholders of both
companies. We expect a smooth transition to the closing of the
The transaction has been approved by the boards of directors of both
companies and is subject to the customary review process under the
Hart-Scott-Rodino Antitrust Improvements Act in the United States and
other customary review processes. The transaction is expected to close
by the end of the second quarter, assuming a standard regulatory
Centerview Partners LLC is acting as exclusive financial advisor to
Biogen Idec. Ropes & Gray LLP is acting as legal counsel to Biogen Idec.
Biogen Idec will host a webcast to discuss this transaction today,
February 6, 2013, at 8:00 a.m. ET/5:00 a.m. PT. George Scangos, Chief
Executive Officer, Biogen Idec, will lead the call.
The call will be broadcast via the internet and will be accessible
through the Investors section of Biogen Idec's homepage, www.biogenidec.com.
Supplemental information in the form of a slide presentation will also
be accessible at the same location on the internet at the time of the
conference call and will be subsequently availale on the website for
TYSABRI is approved in more than 65 countries. TYSABRI is approved in
the United States as a monotherapy for relapsing forms of MS, generally
for patients who have had an inadequate response to, or are unable to
tolerate, an alternative MS therapy. In the European Union, it is
approved for highly active relapsing-remitting MS (RRMS) in adult
patients who have failed to respond to beta interferon or have rapidly
evolving, severe RRMS.
TYSABRI has advanced the treatment of MS patients with its established
efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New
England Journal of Medicine, showed that after two years, TYSABRI
treatment led to a 68 percent relative reduction (p<0.001) in the
annualized relapse rate when compared with placebo and reduced the
relative risk of disability progression by 42-54 percent (p<0.001).
TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain which usually leads
to death or severe disability. Infection by the JC virus (JCV) is
required for the development of PML and patients who are anti-JCV
antibody positive have a higher risk of developing PML. Factors that
increase the risk of PML are presence of anti-JCV antibodies, prior
immunosuppressant use, and longer TYSABRI treatment duration. Patients
who have all three risk factors have the highest risk of developing PML.
Other serious adverse events that have occurred in TYSABRI-treated
patients include hypersensitivity reactions (e.g., anaphylaxis) and
infections, including opportunistic and other atypical infections.
Clinically significant liver injury has also been reported in the
post-marketing setting. A list of adverse events can be found in the
full TYSABRI product labeling for each country where it is approved.
TYSABRI is marketed and distributed by Biogen Idec Inc. and Elan
Corporation, plc. For full prescribing information and more information
about TYSABRI, please visit www.biogenidec.com.
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture
and market therapies for serious diseases with a focus on neurology,
immunology and hemophilia. Founded in 1978, Biogen Idec is the world's
oldest independent biotechnology company. Patients worldwide benefit
from its leading multiple sclerosis therapies and the company generates
more than $5 billion in annual revenues. For product labeling, press
releases and additional information about the company, please visit www.biogenidec.com.
Elan Corporation, plc is a neuroscience-focused biotechnology company
committed to making a difference in the lives of patients and their
families by dedicating itself to bringing innovations in science to fill
significant unmet medical needs that continue to exist around the world.
Elan shares trade on the New York and Irish Stock Exchanges. For
additional information about Elan, please visit www.elan.com.
Biogen Idec Safe Harbor Statement
This press release contains forward-looking statements, including
statements about the expected accretion to earnings per share from the
transaction, TYSABRI's growth prospects, the synergies we expect from
the transaction, and the closing of the transaction. These
forward-looking statements may be accompanied by such words as
"anticipate," "believe," "could," "estimate," "expect," "forecast,"
"intend," "may," "plan," "potential," "project," "target," "will" and
other words and terms of similar meaning. You should not place undue
reliance on these statements.
These statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including uncertainty inherent in regulatory review of the transaction,
our dependence on our three principal products, AVONEX® (interferon
beta-1a), TYSABRI and RITUXAN® (rituximab), the importance of
TYSABRI's sales growth, uncertainty of success in commercializing and
developing other products, product competition, the occurrence of
adverse safety events with our products, changes in the availability of
reimbursement for our products, adverse market and economic conditions,
our dependence on collaborations and other third parties over which we
may not always have full control, problems with our manufacturing
processes and our reliance on third parties, failure to comply with
government regulation, our ability to protect our intellectual property
rights and have sufficient rights to market our products together with
the cost of doing so, the risks of doing business internationally,
failure to manage our growth and execute our growth initiatives, charges
and other costs relating to our properties, fluctuations in our
effective tax rate, our ability to attract and retain qualified
personnel, product liability claims, fluctuations in our operating
results, the market, interest and credit risks associated with our
portfolio of marketable securities, environmental risks and the other
risks and uncertainties that are described in the Risk Factors section
of our most recent annual or quarterly report and in other reports we
have filed with the SEC (News - Alert).
These statements are based on our current beliefs and expectations and
speak only as of the date of this press release. We do not undertake any
obligation to publicly update any forward-looking statements.
Non-GAAP Financial Measures
Our estimate of the transaction's effect on non-GAAP earnings per share
excludes the impact of our projected amortization of the upfront cash
payment and related amounts and the income tax effect related to such
amortization. We believe that the disclosure of this non-GAAP estimate
provides additional insight into the ongoing economics of our business
and reflects how we manage our business internally, set operational
goals and forms the basis of our management incentive programs.
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