Amgen 2012 Annual Report Download - page 59

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Any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products could materially
and adversely affect our product sales, business and operating results. In addition, the perception by the investment community
or stockholders that such recommendations or guidelines will result in decreased use and dosage of our products could adversely
affect the market price for our common stock.
The commercialization of certain of our product candidates and the marketing of certain of our products is dependent in
part on our partners.
We have entered into agreements with third parties to assist in the commercialization of certain of our product candidates
and the marketing of certain of our products in specified geographic areas. (See Item 1. Business — Business Relationships.)
Many of these agreements involve the sharing of certain decisions and a division of responsibilities, costs and benefits. If our
partners fail to effectively deliver on their marketing and commercialization commitments to us or if we and our partners fail to
coordinate our efforts effectively, sales of our products may be materially and adversely affected.
Our risk mitigation measures and corporate compliance program cannot guarantee that we effectively manage all
operational risks and that we are in compliance with all potentially applicable U.S. federal and state regulations and all
potentially applicable foreign regulations and/or other requirements.
The development, manufacturing, distribution, pricing, sales, marketing and reimbursement of our products, together with
our general operations, are subject to extensive federal and state regulation in the United States and to extensive regulation in
foreign countries. (See Our current products and products in development cannot be sold if we do not maintain or gain regulatory
approval and Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.) In
addition, our business is complex and involves significant operational risks. While we have implemented numerous risk mitigation
measures to comply with such regulations in this complex operating environment, we cannot guarantee that we will be able to
effectively mitigate all operational risks. Further, we are now operating under a corporate integrity agreement with the U.S.
Department of Health and Human Services, Office of Inspector General, which requires us to maintain our corporate compliance
program and to undertake a set of defined corporate integrity obligations. The corporate integrity agreement requires us to make
periodic attestations that we are implementing and following the provisions of the corporate integrity agreement, and provides for
an independent third-party review organization to assess and report on our compliance. While we have developed and instituted
a corporate compliance program, we cannot guarantee that we, our employees, our consultants or our contractors are or will be
in compliance with all potentially applicable U.S. federal and state regulations and/or laws, all potentially applicable foreign
regulations and/or laws and/or all requirements of the corporate integrity agreement. If we fail to adequately mitigate our operational
risks or if we or our agents fail to comply with any of those regulations, laws and/or requirements of the corporate integrity
agreement, a range of actions could result, including, but not limited to, the termination of clinical trials, the failure to approve a
product candidate, restrictions on our products or manufacturing processes, withdrawal of our products from the market, significant
fines, exclusion from government healthcare programs or other sanctions or litigation. Such occurrences could have a material
and adverse effect on our product sales, business and results of operations.
Cost savings initiatives may result in the carrying value of certain existing manufacturing facilities or other assets becoming
impaired or other related charges being incurred.
Our business continues to face many challenges. In response to these challenges, we have worked and continue to work to
improve cost efficiencies and to reduce discretionary expenditures. As part of those efforts, we undertake cost savings initiatives
to evaluate our processes and procedures in order to identify opportunities for achieving greater efficiencies in how we conduct
our business. In particular, we evaluate our manufacturing operations to identify opportunities to increase production yields and/
or success rates as well as capacity utilization. Depending on the timing and outcomes of these cost savings initiatives, the carrying
value of certain manufacturing or other assets may not be fully recoverable and could result in the recognition of impairment and/
or other related charges. The recognition of such charges, if any, could have a material adverse effect on our results of operations.
The adoption of new tax legislation or exposure to additional tax liabilities could affect our profitability.
We are subject to income and other taxes in the United States and other jurisdictions in which we do business. As a result,
our provision for income taxes is derived from a combination of applicable tax rates in the various places we operate. Significant
judgment is required for determining our provision for income tax and our tax returns are periodically examined by various tax
authorities. We believe our accrual for tax liabilities is adequate for all open years based on past experience, interpretations of
tax law, and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income
taxes, the ultimate resolution of any tax matters may result in payments greater or less than amounts accrued. Our provision for
income taxes and results of operations in the future could be adversely affected by changes to our operating structure, changes