Our business will continue to face various challenges. Certain of our products will face increasing competitive pressure as
a result of competitive product launches, including from biosimilars. 2016 is the first full year we are competing without patent
protection on several of our principal products in the United States. For additional information, including information on the
expiration of patents for various products, see Part I, Item 1. Business-Marketing, Distribution and Selected Marketed Products-
Patents and see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition.
Current global economic conditions also pose challenges to our business, including continued pressure to reduce healthcare
expenditures. Efforts to reduce healthcare costs are being made by third-party payers including governments and private payers.
In the United States, various actions have been taken aimed at reducing healthcare spending. The continuing prominence of U.S.
budget deficits increases the risk that taxes, fees, rebates, or other federal measures that would further reduce our revenues or
increase our expenses may be enacted. As a result of global economic conditions, as well as public and private health care provider
focus, the industry continues to experience significant pricing pressures and other cost containment measures.
Our long-term success depends to a great extent on our ability to continue to discover, develop and commercialize innovative
products and acquire or collaborate on therapies currently in development by other companies. The discovery and development
of safe and effective new products, as well as the development of additional indications for existing products, are necessary for
the continued strength of our business. We must develop new products over time in order to offset revenue losses when products
lose their exclusivity or competing products are launched, as well as in order to provide for revenue and earnings growth. We
devote considerable resources to R&D activities. However, successful product development in the biotechnology industry is highly
uncertain. We are also confronted by increasing regulatory scrutiny of safety and efficacy both before and after products launch.
Finally, our product sales can be affected by wholesaler and end-user buying patterns. These effects can cause fluctuations
in quarterly product sales and have generally not been significant when comparing full-year product performance to the prior year.
See Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products and Part I, Item 1A. Risk Factors for
further discussion of certain of the factors that could impact our future product sales.