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This excerpt taken from the ELN 20-F filed Feb 26, 2009. Forward-Looking
Statements
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 number of risks and
uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, our results could
be materially affected.
This
Form 20-F
contains forward-looking statements about our financial
condition, results of operations and estimates, business
prospects and products and potential products that involve
substantial risks and uncertainties. These statements can be
identified 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: (1) the potential of
Tysabri®
(natalizumab) and the incidence of serious adverse events
associated with Tysabri (including cases of progressive
multifocal leukoencephalopathy (PML)); (2) the success of
our research and development (R&D) activities (including,
in particular, whether the Phase 3 clinical trials for
bapineuzumab (AAB-001) are successful) and the speed with which
regulatory authorizations and product launches may be achieved;
(3) our ability to maintain financial flexibility and
sufficient cash, cash equivalents, and investments and other
assets capable of being monetized to meet our liquidity
requirements; (4) whether we will be able to enter into or
consummate a definitive transaction as the result of our
evaluation of strategic alternatives and whether we will be able
to enhance shareholder value through that process or any
resulting transaction; (5) whether the proposed acquisition
of Wyeth by Pfizer Inc. will affect our collaboration with
Wyeth; (6) whether restrictive covenants in our debt
obligations will adversely affect us; (7) competitive
developments affecting our products, including the introduction
of generic competition following the loss of patent protection
or marketing exclusivity for our products (including, in
particular,
Maxipime®
(cefepime hydrochloride), which lost its basic
U.S. patent protection in March 2007 and now faces generic
competition,
Azactam®
(aztreonam for injection, USP), which lost its basic
U.S. patent protection in October 2005, and several of the
products from which we derive manufacturing or royalty revenues,
which are under patent challenge by potential generic
competitors); (8) our ability to protect our patents and
other intellectual property; (9) difficulties or delays in
manufacturing our products (we are dependent on third parties
for the manufacture of our products); (10) trade buying
patterns; (11) pricing pressures and uncertainties
regarding healthcare reimbursement and reform; (12) the
failure to comply with anti-kickback and false claims laws in
the United States (including, in particular, with respect to
past marketing practices with respect to our former
Zonegran®
product, which are being investigated by the
U.S. Department of Justice and the U.S. Department of
Health and Human Services. The resolution of the Zonegran matter
could require us to pay substantial fines and to take other
actions that could have a material adverse effect on us);
(13) extensive government regulation; (14) risks from
potential environmental liabilities; (15) failure to comply
with our reporting and payment obligations under Medicaid or
other government programs; (16) exposure to product
liability risks; (17) an adverse effect that could result
from the putative class action lawsuits initiated following the
release of the data from the Phase 2 clinical trial for
bapineuzumab and the outcome of our other pending or future
litigation; (18) the volatility of our stock price;
(19) some of our agreements that may discourage or prevent
someone from acquiring us; and (20) global, as well as local,
political, economic and market conditions, including interest
rate and currency exchange rate fluctuations. We assume no
obligation to update any forward-looking statements, whether as
a result of new information, future events or otherwise, except
as otherwise required by law.
Table of Contents
This excerpt taken from the ELN 20-F filed Feb 28, 2008. Forward-Looking
Statements
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 number of risks and
uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, our results could
be materially affected.
This
Form 20-F
contains forward-looking statements about our financial
condition, results of operations and estimates, business
prospects and products and potential products that involve
substantial risks and uncertainties. These statements can be
identified 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: (1) the potential of
Tysabri®
(natalizumab) and the incidence of serious adverse events
associated with Tysabri (including cases of progressive
multifocal leukoencephalopathy (PML)); (2) the success of
our research and development (R&D) activities (including,
in particular, whether the Phase 2 and 3 clinical trials for
AAB-001 and the Phase 1 clinical trials for ACC-001 are
successful) and the speed with which regulatory authorizations
and product launches may be achieved; (3) our ability to
maintain financial flexibility and sufficient cash, cash
equivalents, and investments and other assets capable of being
monetized to meet our liquidity requirements; (4) whether
restrictive covenants in our debt obligations will adversely
affect us; (5) competitive developments affecting our
products, including the introduction of generic competition
following the loss of patent protection or marketing exclusivity
for our products (including, in particular,
Maxipime®
(cefepime hydrochloride), which lost its basic
U.S. patent protection in March 2007 and now faces generic
competition,
Azactam®
(aztreonam for injection, USP), which lost its basic
U.S. patent protection in October 2005 and several of the
products from which we derive manufacturing or royalty revenues,
which are under patent challenge by potential generic
competitors); (6) our ability to protect our patents and
other intellectual property; (7) difficulties or delays in
manufacturing our products (we are dependent on third parties
for the manufacture of our products); (8) trade buying
patterns; (9) pricing pressures and uncertainties regarding
healthcare reimbursement and reform; (10) the failure to
comply with anti-kickback and false claims laws in the United
States (including, in particular, with respect to past marketing
practices with respect to our former
Zonegran®
product, which are being investigated by the
U.S. Department of Justice and the U.S. Department of
Health and Human Services. The resolution of the Zonegran matter
could require us to pay substantial fines and to take other
actions that could have a material adverse effect on us);
(11) extensive government regulation; (12) risks from
potential environmental liabilities; (13) failure to comply
with our reporting and payment obligations under Medicaid or
other government programs; (14) exposure to product
liability risks; (15) an adverse effect that could result
from the putative class action lawsuits initiated following the
voluntary suspension of the commercialization and clinical
dosing of Tysabri and the outcome of our other pending or
future litigation; (16) the volatility of our stock price;
and (17) some of our agreements that may discourage or
prevent someone from acquiring us. We assume no obligation to
update any forward-looking statements, whether as a result of
new information, future events or otherwise.
Table of Contents
This excerpt taken from the ELN 20-F filed Feb 28, 2007. Forward-Looking
Statements
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 US Private
Securities Litigation Reform Act of 1995. The forward-looking
statements involve a number of risks and uncertainties and are
subject to change at any time. In the event such risks or
uncertainties materialize, our results could be materially
affected.
This
Form 20-F
contains forward-looking statements about our financial
condition, results of operations and estimates, business
prospects and products and potential products that involve
substantial risks and uncertainties. These statements can be
identified 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: (1) the potential of
Tysabri®
(natalizumab), the incidence of serious adverse events
associated with Tysabri (including cases of progressive
multifocal leukoencephalopathy (PML)) and the potential for the
successful development and commercialization of additional
products; (2) the potential of
Prialttm
(ziconotide intrathecal infusion) as an intrathecal
treatment for severe pain; (3) our ability to maintain
financial flexibility and sufficient cash, cash equivalents, and
investments and other assets capable of being monetized to meet
our liquidity requirements; (4) whether restrictive
covenants in our debt obligations will adversely affect us;
(5) competitive developments affecting our products,
including the introduction of generic competition following the
scheduled loss of patent protection or marketing exclusivity for
our products (including, in particular,
Maxipimetm
(cefepime hydrochloride), which loses its basic US patent
protection in March 2007 and
Azactamtm
(aztreonam for injection, USP), which lost its basic US
patent protection in October 2005); (6) our ability to
protect our patents and other intellectual property;
(7) difficulties or delays in manufacturing (including, in
particular, with respect to Maxipime); (8) trade
buying patterns; (9) pricing pressures and uncertainties
regarding healthcare reimbursement and reform; (10) the
failure to comply with anti-kickback and false claims laws in
the United States (including, in particular, with respect to
past marketing practices with respect to our former
Zonegrantm
product, which are being investigated by the US Department of
Justice and the US Department of Health and Human Services. The
resolution of the Zonegran matter could require us to pay
substantial fines and to take other actions that could have a
material adverse effect on us); (11) the success of our
research and development (R&D) activities (including, in
particular, whether the Phase 2 clinical trials for AAB-001
and the Phase 1 clinical trials for ACC-001 are successful)
and the speed with which regulatory authorizations and product
launches may be achieved; (12) extensive government
regulation; (13) risks from potential environmental
liabilities; (14) failure to comply with our reporting and
payment obligations under Medicaid or other government programs;
(15) exposure to product liability risks; (16) an
adverse effect that could result from the putative class action
lawsuits initiated following the voluntary suspension of the
commercialization and clinical dosing of Tysabri and the
outcome of our other pending or future litigation; (17) the
volatility of our stock price; and
Table of Contents
(18) some of our agreements that may discourage or prevent
someone from acquiring us. We assume no obligation to update any
forward-looking statements, whether as a result of new
information, future events or otherwise.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. Forward-Looking
Statements
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 number of risks and
uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, our results could
be materially affected.
This
Form 20-F
contains forward-looking statements about our financial
condition, results of operations and estimates, business
prospects and products that involve substantial risks and
uncertainties. These statements can be identified 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:
(1) whether and when we will be able to resume marketing
and developing
Tysabri®
(natalizumab); (2) even if we can resume marketing and
developing Tysabri, the potential of Tysabri and
the potential for the successful development and
commercialization of additional products; (3) the potential
of
Prialttm
(ziconotide intrathecal infusion) as an intrathecal
treatment for severe pain; (4) our ability to maintain
sufficient cash, cash equivalents, and investments and other
assets capable of being liquidated to meet our liquidity
requirements; (5) whether restrictive covenants in our debt
obligations will adversely affect us; (6) competitive
developments affecting our products, including the introduction
of generic competition following the scheduled loss of patent
protection or marketing exclusivity for our products;
(7) our ability to protect our patents and other
intellectual property; (8) difficulties or delays in
manufacturing; (9) trade buying patterns; (10) pricing
pressures and uncertainties regarding healthcare reimbursement
and reform; (11) the failure to comply with anti-kickback
and false claims laws in the United States; (12) extensive
government regulation; (13) risks from potential
environmental liabilities; (14) failure to comply with our
reporting and payment obligations under Medicaid or other
government programs; (15) exposure to product liability
risks; (16) 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; (17) the volatility of our stock price; and
(18) some of our agreements that may discourage or prevent
someone from acquiring us. We assume no obligation to update any
forward-looking statements, whether as a result of new
information, future events or otherwise.
Table of Contents
This excerpt taken from the ELN 6-K filed Oct 27, 2005. Forward-Looking Statements This document contains forward-looking statements about Elans financial condition, results of operations, business prospects and products in research 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, 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: whether and when Elan will be able to resume marketing and developing Tysabri; even if Elan can resume marketing and developing Tysabri, the potential of Tysabri and the potential for the successful development and commercialization of additional products, including those utilizing Tysabri; the potential of Elans current products; Elans ability to maintain sufficient cash, liquid resources, and investments and other assets capable of being monetized to meet its liquidity requirements; the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; competitive developments affecting Elans products; the ability to successfully market both new and existing products; difficulties or delays in manufacturing and supply of Elans products (including, in particular Maxipime); trade buying patterns; the impact of generic and branded competition after the expiration of Elans patents, including the impact of any generic competition following the loss of patent exclusivity for Azactam in October 2005; whether restrictive covenants in Elans debt obligations will adversely affect Elan; the trend towards managed care and health care cost containment, including Medicare and Medicaid; the potential impact of the Medicare Prescription Drug, Improvement and Modernisation Act 2003; possible legislation affecting pharmaceutical pricing and reimbursement, both domestically and internationally; failure to comply with kickback and false claims laws; failure to comply with its payment obligations under Medicaid and other governmental programmes; exposure to product liability and other types of lawsuits and legal defense costs and the risks of adverse decisions or settlements related to product liability, patent protection, governmental investigations and other legal proceedings; Elans ability to protect its patents and other intellectual property; claims and concerns that may arise regarding the safety or efficacy of Elans products or product candidates; interest rate and foreign currency exchange rate fluctuations; governmental laws and regulations affecting domestic and foreign operations, including tax obligations; general changes in U.S., International and Irish generally accepted accounting principles; growth in costs and expenses; changes in product mix; 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 Elans Form 20-F for the fiscal year ended December 31, 2004,as amended by Amendment No. 1 on Form 20-F/A, and in its Reports of Foreign Issuer on Form 6-K filed with the SEC. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Elan continually evaluates its liquidity requirements, capital needs and availability of resources in view of, among other things, alternative uses of capital, debt service requirements, the cost of debt and equity capital and estimated future operating cash flow. Elan may raise additional capital, restructure or refinance outstanding debt, repurchase material amounts of outstanding debt, consider the sale of products, interests in subsidiaries, marketable investment securities or other assets, or take a combination of such actions or other steps to increase or manage its liquidity and capital resources. Any such actions or steps, including any sale of assets or repurchase of outstanding debt, could be material. In the normal course of business, Elan may investigate, evaluate, discuss and engage in future company or product acquisitions, capital expenditures, investment and other business opportunities. In the event of any future acquisitions, capital expenditures, investment or other business opportunities, Elan may consider using available cash or raising additional capital, including the issuance of additional debt.
14
Elan Third Quarter 2005 Financial Results
This excerpt taken from the ELN 6-K filed Jul 28, 2005. Forward-Looking Statements This document, including the entire section entitled 2005 Outlook Update, and Appendix I and II contains forward-looking statements about Elans financial condition, results of operations, business prospects and products in research 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, 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: whether and when Elan will be able to resume marketing and developing Tysabri; even if Elan can resume marketing and developing Tysabri, the potential of Tysabri and the potential for the successful development and commercialization of additional products, including those utilizing Tysabri; the potential of Elans current products, including in particular, Maxipime and Azactam; Elans ability to maintain sufficient cash, liquid resources, and investments and other assets capable of being monetized to meet its liquidity requirements; the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; competitive developments affecting Elans products; the ability to successfully market both new and existing products; difficulties or delays in manufacturing and supply of Elans products; trade buying patterns; the impact of generic and branded competition after the expiration of Elans patents, including the impact of any generic competition following the loss of patent exclusivity for Azactam in October 2005; whether restrictive covenants in Elans debt obligations will adversely affect Elan; the trend towards managed care and health care cost containment, including Medicare and Medicaid; the potential impact of the Medicare Prescription Drug, Improvement and Modernisation Act 2003; possible legislation affecting pharmaceutical pricing and reimbursement, both domestically and internationally; failure to comply with kickback and false claims laws; failure to comply with its payment obligations under Medicaid and other governmental programmes; exposure to product liability and other types of lawsuits and legal defense costs and the risks of adverse decisions or settlements related to product liability, patent protection, governmental investigations and other legal proceedings; Elans ability to protect its patents and other intellectual property; claims and concerns that may arise regarding the safety or efficacy of Elans products or product candidates; interest rate and foreign currency exchange rate fluctuations; governmental laws and regulations affecting domestic and foreign operations, including tax obligations; general changes in U.S.,International and Irish generally accepted accounting principles; growth in costs and expenses; changes in product mix; 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 Elans Form 20-F for the fiscal year ended December 31, 2004, and in its Reports of Foreign Issuer on Form 6-K filed with the SEC. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Elan continually evaluates its liquidity requirements, capital needs and availability of resources in view of, among other things, alternative uses of capital, debt service requirements, the cost of debt and equity capital and estimated future operating cash flow. Elan may raise additional capital, restructure or refinance outstanding debt, repurchase material amounts of outstanding debt, consider the sale of products, interests in subsidiaries, marketable investment securities or other assets, or take a combination of such actions or other steps to increase or manage its liquidity and capital resources. Any such actions or steps, including any sale of assets or repurchase of outstanding debt, could be material. In the normal course of business, Elan may investigate, evaluate, discuss and engage in future company or product acquisitions, capital expenditures, investment and other business opportunities. In the event of any future acquisitions, capital expenditures, investment or other business opportunities, Elan may consider using available cash or raising additional capital, including the issuance of additional debt.
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