Pfizer 2013 Annual Report Download - page 49

Financial Review
Pfizer Inc. and Subsidiary Companies
48
2013 Financial Report
• 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 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. federal or state 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;
• any 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;
• our ability to protect our patents and other intellectual property, both domestically and internationally;
• interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries
experiencing high inflation rates;
• 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;
• any significant issues involving our largest wholesaler customers, which account for a substantial portion of our revenues;
• the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues
and on patient confidence in the integrity of our medicines;
• any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties,
including with regard to quality, timeliness and compliance with applicable legal requirements and industry standards;
• 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 customers, suppliers and lenders 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
• the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other
unusual items, including our ability to realize the projected benefits of our cost-reduction and productivity initiatives, including