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GUIDANT CORPORATION
EXHIBIT 99.1
Factors Possibly Affecting Future Operating Results
From time to time, the Company may publish forward-looking statements relating
to such matters as anticipated financial performance, business prospects,
technological developments, new products, research and development activities,
and similar matters. The Private Securities Litigation Reform Act of 1995
provides a safe harbor for forward-looking statements. In order to comply with
the terms of the safe harbor, the Company notes that a variety of factors could
cause the Company's actual results and experience to differ materially from the
anticipated results or other expectations expressed in the Company's
forward-looking statements. The risks and uncertainties that may affect the
operations, performance, development, and results of the Company's business
include the following:
1. Economic factors over which the Company has no control, including changes in
inflation, interest rates, and foreign currency exchange rates.
2. Delays and uncertainties in the regulatory approval process in the United
States and other countries, resulting in lost market opportunities.
3. Unexpected safety, performance, or efficacy concerns arising with respect to
marketed products, whether or not scientifically justified, leading to product
recalls, withdrawals, or declining sales.
4. Unexpected interruptions of manufacturing operations as a result of
regulatory enforcement actions by the FDA or other regulatory authorities.
5. The difficulties and uncertainties inherent in new product development,
including new products that appear promising during development but fail to
reach the market as a result of safety, performance or efficacy concerns,
inability to obtain necessary regulatory approvals, unanticipated restrictions
imposed on approved indications, excessive costs to manufacture, infringement of
patents or other intellectual property rights of others, or technological
advances by a competitor of the Company.
6. Litigation and other legal factors which could preclude commercialization of
products or negatively affect the level of sales or profitability of existing
products, including litigation of product liability claims, antitrust
litigation, environmental matters, and patent or other intellectual property
disputes.
7. Future difficulties obtaining necessary components or materials used in
manufacturing the Company's products as the Company cannot quickly establish
additional or replacement suppliers for certain materials, largely due to the
FDA approval system and the complex nature of the manufacturing processes
employed by many suppliers. In addition, certain supplies are from single
sources.
8. Future difficulties obtaining or the inability to obtain appropriate levels
of product liability insurance.
9. Competitive factors including the ability of the Company to obtain patent
rights or other intellectual property rights sufficient to keep competitors from
marketing competing products, the introduction of new products or therapies by
competitors or scientific or medical developments that render the Company's
products obsolete, uneconomical, or otherwise non-competitive, or the
acquisition of patents by competitors that prevent the Company from selling a
product or including key features in the Company's products.
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10. Governmental factors including laws and regulations, policies and judicial
decisions that affect the regulation and reimbursement of medical devices,
product liability, health care reform, or tax laws.
11. Health care industry factors, including increased customer demands for price
concessions, reductions in third-party (Medicare, Medicaid and other
governmental programs, private health care insurance, and managed care plans)
reimbursement levels for procedures using the Company's products, and limits
imposed by customers on the number of manufacturers or vendors which the
customer will purchase products from.
12. Accounting requirements to write off obsolete inventory or goodwill which
reduces reported earnings or changes in accounting standards applicable to the
Company.
13. The ability of the Company to recruit and retain highly skilled personnel
needed to compete in an intensely competitive market and to successfully
develop, market, and sell new products.
14. Internal factors such as change in business strategies and the impact of
restructuring and business combinations.
15. The ability of the Company to implement its strategy that includes the
potential acquisition of one or more businesses and difficulties in achieving
the integration of the operations of acquired businesses in a cost-effective
manner and in implementing strategies necessary for the realization of
anticipated synergies.
16. The Euro Conversion's impact on the competitive environment in which the
Company operates or its impact on the Company's fundamental risk management
philosophy.
17. Factors beyond the control of the Company, including earthquakes
(particularly in light of the fact that the Company has significant facilities
located near major earthquake fault lines), floods, fires, or explosions.
