EXHIBIT 99
Exhibit 99 to the Annual Report on Form 10-K
for the Fiscal Year Ended December 31, 2004
Cautionary Statements Regarding "Safe Harbor" Provisions of the Private
Securities Litigation Reform Act of 1995
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor"
for forward-looking statements. Forward-looking statements may appear in
periodic reports filed with the Securities and Exchange Commission (including
the Company's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q),
in press releases, in the Company's Annual Report to Stockholders and other
reports to stockholders, and in other communications made by the Company. These
forward-looking statements can be identified by their use of words such as
"anticipates," "expects," "is confident," "plans," "could," "will," "believes,"
"estimates," "forecasts," "projects" and other words of similar meaning. These
forward-looking statements address various matters including:
o Our anticipated results of operations, liquidity position, financial
condition and capital resources;
o The benefits that we expect will result from our business activities
and certain transactions we announced or completed, such as increased
revenues, decreased expenses, and avoided expenses and expenditures;
o Statements of our expectations, beliefs, future plans and strategies,
anticipated developments and other matters that are not historical
facts;
o The accuracy of our estimates and assumptions utilized in our critical
accounting policies;
o The timing and successfulness of research and development activities;
o Trade buying patterns;
o The impact of competitive or generic products;
o Economic conditions, including interest rate and foreign currency
exchange rate fluctuation;
o Changes in generally accepted accounting principles;
o Any changes in political or economic conditions due to the threat of
terrorist activity worldwide and related U.S. military action
internationally;
o Costs related to product liability, patent protection, government
investigations and other legal proceedings;
o Our ability to protect our intellectual property, including patents;
o The impact of legislation or regulation affecting pricing,
reimbursement or access, both in the United States and
internationally;
o Impact of managed care or health care cost-containment;
o Increased focus on privacy issues in countries around the world,
including the United States and the European Union;
o Governmental laws and regulations affecting our U.S. and international
businesses, including tax obligations;
o Environmental liabilities;
o The future impact of presently known trends, including those with
respect to product performance and competition;
o Change in product mix;
o Anticipated amounts of future contractual obligations and other
commitments, including future minimum rental payments under
non-cancelable operating leases and estimated future pension and other
postretirement benefit payments;
o Anticipated developments relating to sales of PREMPRO/PREMARIN family
of products, PROTONIX, EFFEXOR, ENBREL, and PREVNAR and ENBREL product
supply; and
o Expectations regarding the impact of potential litigation relating to
PREMPRO, PREMARIN, ROBITUSSIN, DIMETAPP and EFFEXOR; the nationwide
class action settlement relating to REDUX and PONDIMIN; and additional
litigation charges related to REDUX and PONDIMIN.
All forward-looking statements address matters involving numerous assumptions,
risks and uncertainties, which may cause actual results to differ materially
from those expressed or implied by us in those statements. Accordingly, we
caution you not to place undue reliance on these forward-looking statements,
which speak only as of the date on which they were made. From time to time, we
also may provide oral or written forward-looking statements in other materials
we release to the public. Additionally, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future developments or otherwise. As permitted by the Private
Securities Litigation Reform Act of 1995, the Company is hereby filing the
following cautionary statements identifying important factors, which among
others, could cause the Company's actual results to differ materially from
expected and historical results:
Economic factors over which we have no control such as changes in business and
economic conditions, including, but not limited to, inflation and fluctuations
in interest rates, foreign currency exchange rates and market value of our
equity investments and any impacts of war or terrorist acts;
Interruptions of computer and communication systems including computer viruses,
that could impair the Company's ability to conduct business and communicate
internally with its customers;
Increasing pricing pressures, both in and outside the United States, resulting
from continued consolidation among health care providers, rules and practices of
managed care groups and institutional and governmental purchasers, judicial
decisions and governmental laws and regulations relating to Medicare, Medicaid
and health care reform, pharmaceutical reimbursement and pricing in general;
Competitive factors, such as (i) new products developed by our competitors that
have lower prices or superior performance features or that are otherwise
competitive with our current products; (ii) technological advances and patents
attained by our competitors; (iii) changes in promotional regulations or
practices; (iv) development of alternative therapies; (v) potential generic
competition for PREMARIN and for other health care products as such products
mature and patents or marketing exclusivity expire on such products; (vi)
problems with licensors, suppliers and distributors; (vii) business combinations
among our competitors and major customers; and (viii) ability to attract and
retain management and other key employees;
Government laws and regulations affecting U.S. and international operations,
including (i) trade, monetary and fiscal policies and taxes; (ii) price
controls, or reimbursement or access policies; (iii) drug importation
legislation; (iv) changes in governments and legal systems; and (v) regulatory
approval processes affecting approvals of products and licensing, including,
without limitation, uncertainties of the FDA approval process that may delay or
prevent the approval of new products and result in lost market opportunity;
Difficulties and delays inherent in pharmaceutical research, product
development, manufacturing and commercialization, such as, (i) failure of new
product candidates to reach market due to efficacy or safety concerns, inability
to obtain necessary regulatory approvals and the difficulty or excessive cost to
manufacture; (ii) the inability to identify viable new chemical compounds; (iii)
difficulties in successfully completing clinical trials; (iv) difficulties in
manufacturing complex products, particularly biological products, on a
commercial scale; (v) difficulty in gaining and maintaining market acceptance of
approved products; (vi) seizure or recall of products; (vii) the failure to
obtain, the imposition of limitations on the use of, or loss of patent and other
intellectual property rights; (viii) failure to comply with current Good
Manufacturing Practices and other applicable regulations and quality assurance
guidelines that could lead to temporary manufacturing shutdowns, product
shortages and delays in product manufacturing; and (ix) other manufacturing or
distribution problems, including unexpected adverse events or developments at
any of the manufacturing facilities involved in the production of one or more of
the Company's principal products;
Difficulties or delays in product manufacturing or marketing, including but not
limited to, the inability to build up production capacity commensurate with
demand, the inability of our suppliers to provide raw material, or the failure
to predict market demand for or to gain market acceptance of approved products;
Unexpected safety or efficacy concerns arising with respect to marketed
products, whether or not scientifically justified, leading to product recalls,
withdrawals, regulatory action on the part of the FDA (or foreign counterparts)
or declining sales;
Growth in costs and expenses, changes in product mix, and the impact of any
acquisitions or divestitures, restructuring and other unusual items that could
result from evolving business strategies, evaluation of asset realization and
organizational restructuring;
Legal difficulties, any of which can preclude or delay commercialization of
products or adversely affect profitability, such as (i) product liability
litigation related to our products including, without limitation, litigation
associated with DIMETAPP, ROBITUSSIN, PREMPRO, PREMARIN, EFFEXOR, and our former
diet drug products, REDUX and PONDIMIN; (ii) claims asserting violations of
antitrust, securities, or other laws; (iii) tax matters; (iv) intellectual
property disputes or changes in intellectual property legal protections and
remedies; (v) environmental matters, including obligations under the
Comprehensive Environmental Response, Compensation and Liability Act, commonly
known as Superfund; and (vi) complying with the consent decree with the FDA;
Fluctuations in buying patterns of major distributors, retail chains and other
trade buyers which may result from seasonality, pricing, wholesaler buying
decisions or other factors; and
Changes in accounting standards promulgated by the Financial Accounting
Standards Board, the Emerging Issues Task Force, the Securities and Exchange
Commission, and the American Institute of Certified Public Accountants, which
may require adjustments to our financial statements.
This list should not be considered an exhaustive statement of all potential
risks and uncertainties.