Amgen 2007 Annual Report Download - page 84

Opotential for additional label changes for the class of ESAs, including Aranesp®, resulting from
the ODAC meeting on March 13, 2008;
Opending changes to product information from the EMEA for the class of ESAs, including Ara-
nesp®, in Europe;
• our ability to maintain a competitive segment share and differentiate Aranesp®from current and potential
future competition;
• adverse events or results from clinical trials or studies performed by us, including our pharmacovigilance
clinical trials, or by others (including our licensees or independent investigators), such as those referred to
in “Item 1. Business — Key Developments,” 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 products;
• an increasingly competitive environment of products or therapies, including biosimilar products which
have launched in certain countries outside of the United States, for example Roche’s peg-EPO product,
MIRCERA®and Shire’s erythropoietin product Dynepo®(Epoetin delta), and biosimilar products that
have been or are expected to be launched in the future; and
• development of new treatments for cancer and future chemotherapy treatments. For example, those that
are less myelosuppressive may require less Aranesp®;
any or all of which could have a material adverse impact on future sales of Aranesp®.
See “Item 1. Business — Key Developments” 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, 2007, 2006 and 2005, total EPOGEN®sales were as follows (dollar
amounts in millions):
2007 Change 2006 Change 2005
EPOGEN®— U.S. ......................... $2,489 (1)% $2,511 2% $2,455
The decline in EPOGEN®sales for the year ended December 31, 2007 reflects a decrease in demand due to
a decline in dose/utilization, partially offset by patient population growth of 3%. The decline in dose/utilization is
due to physician behavior in making treatment and dosing decisions in response to regulatory and reimbursement
developments, that occurred throughout 2007. As discussed in more detail in “Item 1. Business — Key
Developments,” these developments include the issuance by the NKF of the final KDOQI guidelines, the
March 9, 2007 and November 8, 2007 ESA product label changes and the anticipation of CMS’ announced re-
visions to its EMP, effective January 1, 2008. The decline in sales for the year ended December 31, 2007 was
partially offset by favorable changes in wholesaler inventory and spillover (see Note 1, “Summary of significant
accounting policies — Product sales” to the Consolidated Financial Statements for further discussion).
Reported EPOGEN®sales for the year ended December 31, 2006 increased modestly primarily due to the
increased demand in the free-standing dialysis centers partially offset by the increased use of Aranesp®in the
hospital setting. We believe that conversion to Aranesp®in the hospital setting stabilized in mid-2006. We be-
lieve demand for EPOGEN®in the free-standing dialysis centers, which account for the majority of the
EPOGEN®sales, remained consistent with patient population growth.
In addition to the factors mentioned in the “Product sales” section above, future EPOGEN®sales will be
dependent, in part, on such factors as:
• reimbursement developments including:
Oreimbursement changes resulting from CMS’ announced revisions to its EMP, effective January 1,
2008;
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