Pfizer 2011 Annual Report Download - page 47

Financial Review
Pfizer Inc. and Subsidiary Companies
•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;
•Speed with which regulatory authorizations, pricing approvals and product launches may be achieved;
•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;
•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;
•Ability to meet generic and branded competition after the loss of patent protection for our products or competitor products;
•Ability to successfully market both new and existing products domestically and internationally;
•Difficulties or delays in manufacturing;
•Trade buying patterns;
•Impact of existing and future legislation and regulatory provisions on product exclusivity;
•Trends toward managed care and healthcare cost containment;
•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;
•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;
•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;
•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;
•Significant breakdown, infiltration or interruption of our information technology systems and infrastructure;
•Legal defense costs, insurance expenses, settlement costs, the risk of an adverse decision or settlement and the adequacy of reserves
related to product liability, patent protection, government investigations, consumer, commercial, securities, antitrust, environmental and
tax issues, ongoing efforts to explore various means for resolving asbestos litigation, and other legal proceedings;
•Ability to protect our patents and other intellectual property both domestically and internationally;
•Interest rate and foreign currency exchange rate fluctuations;
•Governmental laws and regulations affecting domestic and foreign operations including, without limitation, tax obligations and changes
affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals;
•Changes in U.S. generally accepted accounting principles;
•Uncertainties related to general economic, political, business, industry, regulatory and market conditions, including, without limitation,
uncertainties related to the impact on us, our lenders, our customers, our suppliers and counterparties to our foreign-exchange and
interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets;
and the related risk that our allowance for doubtful accounts may not be adequate;
•Any changes in business, political and economic conditions due to actual or threatened terrorist activity in the U.S. and other parts of
the world and related U.S. military action overseas;
•Growth in costs and expenses;
•Changes in our product, segment and geographic mix; and
46 2011 Financial Report