Elan Corporation (ELN)

Cautionary Factors That May Affect Future

Statements included herein that are not
historical facts are forward-looking
statements. Such forward-looking statements
are made pursuant to the safe harbor
provisions of the U.S. Private Securities
Litigation Reform Act of 1995. The forward-
looking statements involve a

26  Elan Corporation, plc 2004 Annual Report

number of risks and uncertainties and are
subject to change at any time. In the event
such risks or uncertainties materialise, our
results could be materially affected.

This Annual Report contains forward-looking
statements about our financial condition,
results of operations and estimates, business
prospects and products that involve
substantial risks and uncertainties. You can
identify these statements by the fact that they
use words such as “anticipate”, “estimate”,
“project”, “intend”, “plan”, “believe” 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:

We assume no obligation to update any
forward-looking statements, whether as a
result of new information, future events or
otherwise.

•

Whether and when we will be able to
resume marketing and developing
Tysabri;

•

Even if we can resume marketing and developing Tysabri , the potential of
Tysabri and the potential for the
successful development and
commercialisation of additional products;

•

The potential of Prialt as an intrathecal
treatment for severe pain;

•

Our ability to maintain sufficient cash,
liquid resources, and investments and
other assets capable of being liquidated
to meet our liquidity  requirements;

•

Whether restrictive covenants in our
debt obligations will adversely affect us;

•

Competitive developments affecting
our products, including the introduction
of generic competition following the
scheduled loss of patent protection or
marketing exclusivity for our products;

•

Our ability to protect our patents and
other intellectual property;

•

Difficulties or delays in manufacturing;

•

Trade buying patterns;

•

Pricing pressures and uncertainties
regarding healthcare reimbursement
and reform;

•

The failure to comply with anti-kickback
and false claims laws in the United
States;

•

Risks from potential environmental
liabilities

•

Failure to comply with our reporting and
payment obligations under Medicaid or
other government programmes;

•

Exposure to product liability risks;

•

An adverse effect that could result from
the purported class action lawsuits
initiated following the voluntary
suspension of the marketing and  
clinical dosing of Tysabri;

•

Extensive government regulation;

•

The volatility of our share price; and

•

Some of our agreements that may
discourage or prevent someone from
acquiring us.