Johnson and Johnson 2015 Annual Report Download - page 105

EXHIBIT 99
CAUTIONARY STATEMENT PURSUANT TO PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995 – “SAFE HARBOR” FOR FORWARD-LOOKING STATEMENTS
The Company may from time to time make certain forward-looking statements in publicly-released materials, both
written and oral. Forward-looking statements do not relate strictly to historical or current facts and reflect
management’s assumptions, views, plans, objectives and projections about the future. Forward-looking statements may
be identified by the use of words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and other words of similar
meaning in conjunction with, among other things, discussions of future operations, financial performance, the
Company’s strategy for growth, product development, regulatory approvals, market position and expenditures.
Forward-looking statements are based on current beliefs, expectations and assumptions regarding future events. These
statements therefore are subject to uncertainties, risks and changes that are difficult to predict and many of which are
outside of the Company’s control. Investors should realize that if underlying assumptions prove inaccurate or known or
unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and
projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements.
Furthermore, the Company does not undertake to update any forward-looking statements as a result of new information
or future events or developments.
Some important factors that could cause the Company’s actual results to differ materially from those expressed or
implied in the Company’s forward-looking statements are as follows:
•Economic factors, including inflation and fluctuations in interest rates and currency exchange rates and the potential
effect of such fluctuations on revenues, expenses and resulting margins;
•Competitive factors, including technological advances achieved and patents attained by competitors as well as new
products introduced by competitors, and market share gains by competitors’ branded products or by biosimilar or
generic products/store brands;
•Challenges to the Company’s patents by competitors or allegations that the Company’s products infringe the
patents of third parties, which could adversely affect the Company’s ability to sell the products in question, result in a
loss of sales due to a loss in market exclusivity and require the payment of past damages and future royalties. In
particular, firms have filed Abbreviated New Drug Applications or Biosimilar Biological Product Applications with the
FDA or otherwise challenged the coverage and/or validity of the Company’s patents, seeking to market generic or
biosimilar forms of many of the Company’s key pharmaceutical products prior to expiration of the applicable patents
covering those products. In the event that the Company is not successful in defending the resulting lawsuits, generic
or biosimilar versions of the products at issue will be introduced to the market, resulting in the potential for
substantial market share and revenue losses;
•The impact of patent expirations on the Company’s business and operating results. As patents expire, competitors
may be able to legally produce and market similar products or technologies, including biosimilars and generics, which
would have a material adverse effect on the Company’s sales and results of operations;
•Significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of
health care products and services, including delaying medical procedures, rationing prescription medications,
reducing the frequency of physician visits and foregoing health care insurance coverage;
•The impact on international operations from financial instability in international economies, sovereign risk, possible
imposition of governmental controls and restrictive economic policies, and unstable international governments and
legal systems;
•Health care changes in the U.S. and other countries resulting in pricing pressures, including the continued
consolidation among health care providers, trends toward managed care and health care cost containment, the shift
towards governments becoming the primary payers of health care expenses and laws and regulations relating to
sales and promotion, reimbursement, access, and pricing, generally;
•The potential that the expected benefits and opportunities related to the planned restructuring actions in the Medical
Device segment may not be realized or may take longer to realize than expected, including due to any required
consultation procedures relating to restructuring of workforce;
•Uncertainty of commercial success for new and existing products and of the ability of the Company to successfully
execute strategic plans, including restructuring plans;
Johnson & Johnson 2015 Annual Report