Pfizer 2012 Annual Report Download - page 46

Financial Review
Pfizer Inc. and Subsidiary Companies
2012 Financial Report 45
“believe,” “target,” “forecast,” “goal”, “objective” and other words and terms of similar meaning or by using future dates in connection with any
discussion of, among other things, our anticipated future operating or financial performance, business plans and prospects, in-line products
and product candidates, strategic reviews, capital allocation, business-development plans and plans relating to share repurchases and
dividends. In particular, these include statements relating to future actions, business plans and prospects, prospective products or product
approvals, future performance or results of current and anticipated products, sales efforts, expenses, interest rates, foreign exchange rates,
the outcome of contingencies, such as legal proceedings, plans relating to share repurchases and dividends, government regulation and
financial results, including, in particular, the financial guidance set forth in the “Our Financial Guidance for 2013” section of this Financial
Review and the anticipated costs and cost reductions set forth in the “Restructuring Charges and Other Costs Associated with Acquisitions
and Cost-Reduction/Productivity Initiatives” section of this Financial Review. Among the factors that could cause actual results to differ
materially from past and projected future results are the following:
• the outcome of research and development activities including, without limitation, the ability to meet anticipated
clinical trial commencement and completion dates, regulatory submission and approval dates, and launch dates for
product candidates;
• decisions by regulatory authorities regarding whether and when to approve our drug applications, as well as their
decisions regarding labeling, ingredients and other matters that could affect the availability or commercial potential of
our products;
• the speed with which regulatory authorizations, pricing approvals and product launches may be achieved;
• the outcome of post-approval clinical trials, which could result in the loss of marketing approval for a product or
changes in the labeling for, and/or increased or new concerns about the safety or efficacy of, a product that could
affect its availability or commercial potential;
• the success of external business-development activities;
• competitive developments, including the impact on our competitive position of new product entrants, in-line branded
products, generic products, private label products and product candidates that treat diseases and conditions similar to
those treated by our in-line drugs and drug candidates;
• the implementation by the FDA of an abbreviated legal pathway to approve biosimilar products, which could subject
our biologic products to competition from biosimilar products in the U.S., with attendant competitive pressures, after
the expiration of any applicable exclusivity period and patent rights;
• the ability to meet generic and branded competition after the loss of patent protection for our products or competitor
products;
• the ability to successfully market both new and existing products domestically and internationally;
• difficulties or delays in manufacturing;
• trade buying patterns;
• the impact of existing and future legislation and regulatory provisions on product exclusivity;
• trends toward managed care and healthcare cost containment;
• the impact of the U.S. Budget Control Act of 2011 (the Budget Control Act) and the deficit-reduction actions to be
taken pursuant to the Budget Control Act in order to achieve the deficit-reduction targets provided for therein, and the
impact of any broader deficit-reduction efforts;
• the possible failure of the U.S. federal government to suspend enforcement of the federal debt ceiling beyond May 18, 2013 or to
increase the federal debt ceiling and any resulting inability of the federal government to satisfy its financial obligations, including under
Medicare, Medicaid and other publicly funded or subsidized health programs;
• the impact of U.S. healthcare legislation enacted in 2010—the Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Reconciliation Act––and of any modification or repeal of any of the provisions
thereof;
• U.S. legislation or regulatory action affecting, among other things, pharmaceutical product pricing, reimbursement or
access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; the importation
of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries;
direct-to-consumer advertising and interactions with healthcare professionals; and the use of comparative effectiveness
methodologies that could be implemented in a manner that focuses primarily on the cost differences and minimizes the
therapeutic differences among pharmaceutical products and restricts access to innovative medicines;
• legislation or regulatory action in markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or
access, including, in particular, continued government-mandated price reductions for certain biopharmaceutical
products in certain European and emerging market countries;
• the exposure of our operations outside the U.S. to possible capital and exchange controls, expropriation and other
restrictive government actions, changes in intellectual property legal protections and remedies, as well as political
unrest and unstable governments and legal systems;
• contingencies related to actual or alleged environmental contamination;
• claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates;