Amgen 2007 Annual Report Download - page 85

Oreimbursement changes resulting from current or future product label changes;
Ochanges in reimbursement rates or a change in the basis for reimbursement by the federal govern-
ment;
• regulatory developments, including:
Oproduct label changes occurring on November 8, 2007 and March 9, 2007 in the United States for
the class of ESAs, including Aranesp®and EPOGEN®;
Opending product label changes in the United States for the class of ESAs, including Aranesp®and
EPOGEN®, as a result of discussions with the FDA regarding safety data from the PREPARE and
GOG-191 studies and the submission of a PAS in December 2007 that addressed questions raised
at the May 10, 2007 ODAC meeting;
• governmental or private organization regulations or guidelines relating to the use of our products, includ-
ing:
Ochanges in medical guidelines resulting from the NKF issuance of the final KDOQI guidelines;
Olegislative actions;
• 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;
• cost containment pressures from the federal government on healthcare providers; and
• pricing strategies;
any or all of which could have a material adverse impact on future sales of EPOGEN®.
See “Item 1. Business — Key Developments” and “Item 1A. Risk Factors” for further discussion of certain of
the above factors that could impact our future product sales.
Neulasta®/NEUPOGEN®
For the years ended December 31, 2007, 2006 and 2005, total Neulasta®/NEUPOGEN®sales by geographic
region were as follows (dollar amounts in millions):
2007 Change 2006 Change 2005
Neulasta®— U.S. ....................................... $2,351 6% $2,217 17% $1,900
NEUPOGEN®— U.S. ................................... 861 4% 830 3% 805
U.S. Neulasta®/NEUPOGEN®— Total ...................... 3,212 5% 3,047 13% 2,705
Neulasta®— International ................................ 649 32% 493 27% 388
NEUPOGEN®— International ............................. 416 9% 383 (7)% 411
International Neulasta®/NEUPOGEN®— Total ............... 1,065 22% 876 10% 799
Total Worldwide Neulasta®/NEUPOGEN®................... $4,277 9% $3,923 12% $3,504
The increase in U.S. Neulasta®/NEUPOGEN®sales for the year ended December 31, 2007 was driven by
demand for Neulasta®primarily due to segment growth and, to a lesser degree, favorable changes to wholesaler
inventory levels. The increase in international Neulasta®/NEUPOGEN®sales for the year ended December 31,
2007 was driven by the continued conversion to Neulasta®from NEUPOGEN®and changes in foreign exchange,
which positively impacted the year ended December 31, 2007 combined sales by $74 million. Excluding the im-
pact of foreign currency exchange rate changes, combined international Neulasta®/NEUPOGEN®sales increased
13%.
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