Amgen 2009 Annual Report Download - page 83

• regulatory developments, including those resulting from:
Othe REMS for our ESAs or other risk management activities undertaken by us or required by the FDA
or other regulatory authorities;
Othe proposed FDA advisory committee meeting in 2010 to re-evaluate the use of ESAs in CKD;
Ofuture product label changes;
• changes in dose fluctuations as healthcare providers’ continue to refine their treatment practices to main-
tain patient Hb levels in the 10 to 12 g/dL range;
• proposed healthcare reform in the United States;
• severity and duration of the current global economic downturn;
• governmental or private organization regulations or guidelines relating to the use of our products, includ-
ing changes in medical guidelines and legislative actions;
• 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;
• our contracting and related pricing strategies;
• changes in dose utilization;
• development of new modalities or therapies to treat anemia associated with CRF; and
• patient population growth.
Certain of the above factors could have a material adverse impact on future sales of EPOGEN®.
See “Item 1. Business — Key Developments,”“Item 1. Business — Marketed Products and Selected Product
Candidates” 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, 2009, 2008 and 2007, total Neulasta®/NEUPOGEN®sales by geographic
region were as follows (dollar amounts in millions):
2009 Change 2008 Change 2007
Neulasta®— U.S. ....................................... $2,527 1% $2,505 7% $2,351
NEUPOGEN®— U.S. ................................... 901 1% 896 4% 861
U.S. Neulasta®/NEUPOGEN®— Total .................. 3,428 1% 3,401 6% 3,212
Neulasta®— International ................................ 828 2% 813 25% 649
NEUPOGEN®— International ............................. 387 (13)% 445 7% 416
International Neulasta®/NEUPOGEN®— Total ........... 1,215 (3)% 1,258 18% 1,065
Total Neulasta®/NEUPOGEN®............................ $4,643 (0)% $4,659 9% $4,277
U.S. sales of Neulasta®/NEUPOGEN®for the year ended December 31, 2009 increased 1%, primarily due
to a low single digit increase in demand partially offset by unfavorable changes in wholesaler inventories. The
increase in demand was principally due to an increase in the average net sales price. International Neulasta®/
NEUPOGEN®sales for the year ended December 31, 2009 decreased 3%, due to the unfavorable impact of
changes in foreign currency exchange rates, partially offset by an increase in demand. For the year ended De-
cember 31, 2009, excluding the impact of foreign currency exchange rate changes of approximately $94 million,
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