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EXHIBIT 99. CAUTIONARY STATEMENT UNDER PRIVATE SECURITIES
LITIGATION REFORM ACT OF 1995 - "SAFE HARBOR" FOR
FORWARD-LOOKING DISCLOSURES
Certain forward-looking statements are included in this Form 10-Q and may be
made by company spokespersons based on current expectations of management. All
forward-looking statements made by the company are subject to risks and
uncertainties. Certain factors, including but not limited to those listed below,
may cause actual results to differ materially from current expectations and
historical results.
- Competitive factors, including generic competition as patents on key
products, such as Prozac, expire; pricing pressures, both in the U.S. and
abroad, primarily from managed care groups and government agencies; and new
patented products or expanded indications for existing products introduced by
competitors, which can lead to declining demand for the company's products.
- Changes in inventory levels maintained by pharmaceutical wholesalers can
cause reported sales for a particular period to differ significantly from
underlying prescriber demand.
- Economic factors over which the company has no control, including changes in
inflation, interest rates and foreign currency exchange rates, and overall
economic conditions in volatile areas such as Latin America.
- Governmental factors, including federal, state and foreign laws and
regulations that affect pharmaceutical pricing, including Medicaid, Medicare,
pharmaceutical importation laws, and other laws and regulations that could,
directly or indirectly, impose governmental controls on the prices at which
the company's products are sold.
- The difficulties and uncertainties inherent in new product development. New
product candidates that appear promising in development may fail to reach the
market or may have only limited commercial success because of efficacy or
safety concerns, inability to obtain necessary regulatory approvals,
difficulty or excessive costs to manufacture, or infringement of the patents
or intellectual property rights of others.
- Delays and uncertainties in the FDA approval process and the approval
processes in other countries, resulting in lost market opportunity.
- Unexpected safety or efficacy concerns arising with respect to marketed
products, whether or not scientifically justified, leading to product
recalls, withdrawals or declining sales.
- Legal factors including unanticipated litigation of product liability or
other liability claims; antitrust litigation; environmental matters; and
patent disputes with competitors which could preclude commercialization of
products or negatively affect the profitability of existing products. In
particular see "Financial Expectations for 2001 and 2002" under Part I, Item
2, Management's Discussion and Analysis of Financial Condition and Results of
Operations, for a discussion of the expected impact of litigation involving
the company's U.S. patents on Prozac. In addition, the company has applied to
the U.S. FDA under applicable law for an additional six months of U.S. market
exclusivity after the Prozac patent expiry based on studies conducted in
pediatric populations. While the company believes it will receive the
additional six months of exclusivity, there can be no assurance that this
will occur.
- Changes in tax laws, including laws related to the remittance of foreign
earnings or investments in foreign countries with favorable tax rates, and
settlements of federal, state, and foreign tax audits.
- Changes in accounting standards promulgated by the Financial Accounting
Standards Board, the Securities and Exchange Commission, and the American
Institute of Certified Public Accountants which are adverse to the company.
- Internal factors such as changes in business strategies and the impact of
restructurings and business combinations.
