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Elan Provides Update Post Restructuring Announcement of Tysabri Collaboration
DUBLIN --(Business Wire)--
Elan Corporation, plc (NYSE:ELN) today provides an update to the market
post the February 6, 2013 announcement regarding the restructuring of
the Tysabri® collaboration with Biogen Idec. As previously announced,
under the terms of this agreement, Elan will move from the current 50:50
business collaboration to an upfront payment of $3.25 billion and a
double digit tiered royalty structure for the life of the complete
Tysabri asset.
Mr Kelly Martin, CEO commented, "Understandably, many market
participants are looking forward to further clarity around how we intend
to deploy the significant upfront payment we will be receiving from
Biogen Idec upon the close of our transaction. The goal of this
communication is to provide additional information to our investors." Mr
Martin continued, "We have been making significant progress in this
regard and are prepared to move expeditiously, upon close, on the
redeployment of capital."
The Board of Directors, executive management and a number of our key
advisors have been working on a possible restructuring of the Tysabri
relationship for many years. The unlocking of a portion of the Tysabri
asset value provides Elan with significant strategic flexibility and a
unique opportunity to reset the company along a number of dimensions.
Upon the closing of the Tysabri transaction Elan will, in accordance
with applicable law and regulation (including by obtaining any required
consents or approvals), execute along three dimensions:
I. Strategic Initiatives: A portion of the $ 3.25 billion will be
invested into a variety of business assets. From a portfolio point of
view, these assets will, characteristically, diversify Elan from a
product, science/clinical, therapeutic, and geographic point of view. As
mentioned previously, in anticipation of agreeing to the Tysabri
restructuring, we have spent significant time evaluating assets around
the world and establishing relationships that might ultimately lead to
constructive strategic transactions. We are pleased with our progress
along these lines. We are enthusiastic about the opportunities that
exist and we expect to be in a position to announce a number of
strategic transactions upon or following the close of the Tysabri
restructuring.
II. Debt Refinancing: Following closing of the Tysabri
transaction, Elan will refinance its outstanding debt. We have worked
closely with the credit markets over the past ten years and value the
access to capital and long standing relationships that we have with our
creditors. Details regarding the refinancing will be made public
following the close of the Tysabri restructuring.
III. Share Repurchase: Following closing, we will institute a
share repurchase program by utilizing $1 billion of the upfront proceeds
from the Tysabri restructuring, with the method to be detailed following
the transaction closing. This enables a significant portion of the
unlocked value of Tysabri to be returned to shareholders directly.
Additionally, and as outlined previously, the upfront cash payment to
Elan will have little to no tax burden and part of our objective is to
enable shareholders to benefit directly from that structural advantage.
Following this transaction, Elan retains over $1.5 billion in
accumulated tax losses and other structures as well as our favorable
Irish tax structure. We greatly value our shareholder relationships and
the access to equity capital these relationships give us and we
appreciate the time horizon of many of our long term holders. We will
continue to work on ways to unlock incremental value to their direct
benefit.
In closing, Kelly Martin concluded, "Our actions over th past years
have been consistent in theme and execution. We have reduced risk
(financial, asset concentration, infrastructure burden) while, at the
same time, preserving the upside from future advancement of science,
clinical or commercial products. By unlocking a portion of the Tysabri
asset value while retaining a significant earnings upside, we have a
unique opportunity to reward shareholders, diversify our business and
create a highly distinctive business platform upon which to advance to
the benefit of shareholders and patients around the world."
About Elan
Elan is a biotechnology company, headquartered in Ireland, 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. For
additional information about Elan, please visit http://www.elan.com.
About Tysabri
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.
Forward Looking Statements
This document contains forward-looking statements about Elan's
financial condition, results of operations, business prospects and
Tysabri that involve substantial risks and uncertainties. You can
identify these statements by the fact that they use words such as
"anticipate", "estimate", "project", "target", "intend", "plan", "will",
"believe", "expect" and other words and terms of similar meaning in
connection with any discussion of future operating or financial
performance or events. Among the factors that could cause actual
results to differ materially from those described or projected herein
are the following: the risk that the Tysabri transaction does not
complete, the potential of Tysabri, which may be severely constrained by
increases in the incidence of serious adverse events (including death)
associated with Tysabri (in particular, by increases in the incidence
rate for cases of PML), or by competition from existing or new therapies
(in particular, oral therapies), and the potential for the successful
development and commercialization of additional products, whether
internally or by acquisition, especially given the separation of the
Prothena business which left us with no material pre-clinical research
programs or capabilities; Elan's ability to maintain sufficient cash,
liquid resources, and investments and other assets capable of being
monetized to meet its liquidity requirements; the success of our
development activities, and research and development activities in which
we retain an interest, including, in particular, the impact of the
announced discontinuation of the development of bapineuzumab intravenous
in mild to moderate Alzheimer's disease; failure to comply with
anti-kickback, bribery and false claims laws in the United States,
Europe and elsewhere; difficulties or delays in manufacturing and
supply of Tysabri; trade buying patterns; the impact of potential
biosimilar competition, whether restrictive covenants in Elan's debt
obligations will adversely affect Elan; the trend towards managed care
and health care cost containment, including Medicare and Medicaid;
legislation and other developments affecting pharmaceutical pricing and
reimbursement (including, in particular, the dispute in Italy with
respect to Tysabri sales), both domestically and internationally;
failure to comply with Elan's payment obligations under Medicaid and
other governmental programs; exposure to product liability (including,
in particular, with respect to Tysabri) and other types of lawsuits and
legal defense costs and the risks of adverse decisions or settlements
related to product liability, patent protection, securities class
actions, governmental investigations and other legal proceedings; Elan's
ability to protect its patents and other intellectual property; claims
and concerns that may arise regarding the safety or efficacy of Elan's
products or product candidates; interest rate and foreign currency
exchange rate fluctuations and the risk of a partial or total collapse
of the euro; governmental laws and regulations affecting domestic and
foreign operations, including tax obligations; if the Tysabri
transaction completes, whether we are deemed to be an Investment Company
or a Passive Foreign Investment Company; general changes in United
States and International generally accepted accounting principles;
growth in costs and expenses; and the impact of acquisitions,
divestitures, restructurings, product withdrawals and other unusual
items. A further list and description of these risks, uncertainties and
other matters can be found in Elan's Annual Report on Form 20-F for the
fiscal year ended December 31, 2012, and in its Reports of Foreign
Issuer on Form 6-K filed with the SEC (News - Alert). Elan assumes no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.

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