Amgen 2009 Annual Report Download - page 82

• adverse events or results from clinical trials, including sub-analyses, studies or meta-analyses performed
by us, including our pharmacovigilance clinical trials, or by others (including our licensees or in-
dependent investigators), which have and could further impact product safety labeling, negatively impact
healthcare provider prescribing behavior, use of our product, regulatory or private healthcare organization
medical guidelines and reimbursement practices;
• governmental or private organization regulations or guidelines relating to the use of our product;
• our contracting and related pricing strategies;
• severity and duration of the current global economic downturn;
• development of new protocols, tests and/or treatments for cancer and/or new chemotherapy treatments or
alternatives to chemotherapy that may have reduced and may continue to reduce the use of chemotherapy
in some patients;
• patient population growth; and
• expansion into new international territories.
Certain of the above factors could have a material adverse impact on future sales of Aranesp®.
See “Item 1. Business — Key Developments,”“Item 1. Business — Marketed Products and Selected Product
Candidates” and “Item 1A. Risk Factors” herein for further discussion of certain of the above factors that could
impact our future product sales.
EPOGEN®
For the years ended December 31, 2009, 2008 and 2007, total EPOGEN®sales were as follows (dollar
amounts in millions):
2009 Change 2008 Change 2007
EPOGEN®— U.S. ...................................... $2,569 5% $2,456 (1)% $2,489
EPOGEN®sales for the year ended December 31, 2009 increased 5%, primarily due to an increase in de-
mand. The increase in demand was principally due to patient population growth, increased dose utilization and an
increase in the average net sales price.
The 1% decrease in EPOGEN®sales for the year ended December 31, 2008 was primarily due to a decrease
in demand, reflecting a decline in the average net sales price. The increase in demand resulting from patient pop-
ulation growth was offset by a decline in dose/utilization in certain settings. The decline in dose/utilization was
related to various ESA product safety-related label changes during 2008 and 2007 and the CMS revision to its
EMP, which became effective January 1, 2008. We believe that the EMP implementation significantly impacted
physician behavior resulting in declines in dosing trends, as particularly noted in the quarter of implementation.
However, this dose decline subsequently moderated throughout 2008.
In addition to other factors mentioned in the “Product sales” section above, future EPOGEN®sales will be
dependent, in part, on such factors as:
• reimbursement developments, including those resulting from:
Ochanges in reimbursement rates or changes in the basis for reimbursement by the federal and state gov-
ernments, including Medicare and Medicaid, such as the CMS proposed rule to implement the
bundled prospective payment system, which becomes effective in 2011, for dialysis services, drugs
and biologicals furnished for treatment of ESRD that are currently billed separately;
Othe federal government’s reaction to regulatory developments, including the REMS for our ESAs,
which has been recently approved by the FDA, and future product label changes;
Othe CMS’ MEDCAC meeting in March 2010 to examine currently available evidence on the use of
ESAs to manage anemia in patients who have CKD;
Ocost containment pressures from the federal and state governments on healthcare providers;
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