Pfizer 2015 Annual Report Download - page 59

Financial Review
Pfizer Inc. and Subsidiary Companies
58
2015 Financial Report
FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS
This report and other written or oral statements that we make from time to time contain forward-looking statements that set forth anticipated
results based on management’s plans and assumptions. Such forward-looking statements involve substantial risks and uncertainties. We have
tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,”
“expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal”, “objective”, “aim” 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 and 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, our acquisition of Hospira, our pending combination with Allergan plc, 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 2016” section of this Financial Review, the
anticipated costs and cost savings set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook” and “Costs
and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” sections of
this Financial Review and in Notes to Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with
Acquisitions and Cost-Reduction/Productivity Initiatives, the benefits, including synergies, expected from our recent acquisition of Hospira, the
expected timing of completion, tax treatment and benefits of our pending combination with Allergan and the expected timing of a decision
regarding a potential separation of our Innovative Products and Established Products businesses, set forth in the “Overview of Our
Performance, Operating Environment, Strategy and Outlook” section of this Financial Review, the planned capital spending set forth in the
“Analysis of Financial Condition, Liquidity and Capital Resources––Selected Measures of Liquidity and Capital Resources––Contractual
Obligations” section of this Financial Review and the contributions that we expect to make from our general assets to the Company’s pension
and postretirement plans during 2016 set forth in the “Analysis of Financial Condition, Liquidity and Capital Resources––Selected Measures of
Liquidity and Capital Resources––Contractual Obligations” section of this Financial Review and in Notes to Consolidated Financial
Statements––Note 11. Pension and Postretirement Benefit Plans and Defined Contribution Plans. Among the factors that could cause actual
results to differ materially from past results and future plans and projected future results are the following:
• the outcome of research and development activities, including, without limitation, the ability to meet anticipated pre-clinical and clinical trial
commencement and completion dates, regulatory submission and approval dates, and launch dates for product candidates, as well as the
possibility of unfavorable pre-clinical and clinical trial results, including unfavorable new clinical data and additional analyses of existing
clinical data;
• decisions by regulatory authorities regarding whether and when to approve our drug applications, which will depend on the assessment by
such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by
regulatory authorities regarding labeling, ingredients and other matters that could affect the availability or commercial potential of our
products; and uncertainties regarding our ability to address the comments in complete response letters received by us with respect to
certain of our drug applications to the satisfaction of the FDA;
• 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;
• risks associated with interim data, including the risk that final results of studies for which interim data have been provided and/or additional
clinical trials may be different from (including less favorable than) the interim data results and may not support further clinical development
of the applicable product candidate or indication;
• the success of external business-development activities, including the ability to satisfy the conditions to closing of announced transactions in
the anticipated time frame or at all;
• 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 and regulatory authorities in certain other countries of an abbreviated legal pathway to approve biosimilar
products, which could subject our biologic products to competition from biosimilar products, 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 any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health
programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented, and/or any significant
additional taxes or fees that may be imposed on the pharmaceutical industry as part of any broad deficit-reduction effort;
• 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, repeal or invalidation of any of the provisions thereof;