Amgen 2011 Annual Report Download - page 88

Ocost containment pressures; and
Othe mix of reimbursement from governmental and private payers;
• clinical trial outcomes, including adverse events or results from clinical trials, including sub-analyses,
studies or meta-analyses performed by us or by others (including our licensees or independent
investigators), which could impact product safety labeling and may negatively impact healthcare provider
prescribing behavior, use of our products, regulatory or private healthcare organization medical guidelines
and reimbursement practices;
• competitive products, including biosimilars;
• physician and patient compliance with product dosing regimens;
• changes in clinical practice, including those resulting from the development of new protocols, tests and/or
treatments;
• adoption of and adherence to risk management activities, such as a REMS, undertaken by us or required
by the FDA or other regulatory authorities;
• product label changes;
• patient population growth;
• segment growth and penetration;
• new product launches and indications;
• expansion into new international markets;
• patent expirations and our ability to obtain and defend our patent and other intellectual property rights;
• fluctuations in foreign currency exchange rates;
• adequacy of product supply and distribution;
• effectiveness of our marketing efforts, including those conducted under collaboration agreements;
• concentration of customer purchasing power; and
• acquisitions and divestures.
Our U.S. product sales are also subject to certain other influences throughout the year, including wholesaler
and end-user buying patterns (e.g., holiday-driven wholesaler and end-user stocking, contract-driven buying and
patients purchasing products later in the year after satisfying their annual insurance deductibles). Such factors can
result in higher demand for our products and/or higher wholesaler inventory levels and, therefore, higher product
sales for a given three-month period, generally followed by a reduction in demand and/or a drawdown in
wholesaler inventories and a corresponding decline in product sales in the subsequent three-month period. For
example, sales of certain of our products in the United States for the three months ended March 31 have been
slightly lower relative to the immediately preceding three-month period, which we believe to be due, in part, to
certain of these factors. While this can result in variability in quarterly product sales on a sequential basis, these
effects have generally not been significant when comparing product sales in the three months ended March 31
with product sales in the corresponding period of the prior year.
In addition, general economic conditions may affect, or in some cases amplify, certain of these factors with
a corresponding impact on our product sales.
See Item 1. Business — Marketed Products for a discussion of our principal products and their approved
indications.
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