Amgen 2007 Annual Report Download - page 82

There are many economic and industry-wide factors that affect our business generally and uniquely, includ-
ing, among others, those relating to increased complexity and cost of R&D due, in part, to greater scrutiny of
clinical trials with respect to safety which may lead to fewer treatments being approved by the FDA or other
regulatory bodies and/or safety-related label changes for approved products; increasingly intense competition for
marketed products and product candidates; reimbursement changes; healthcare provider prescribing behavior,
regulatory or private healthcare organization medical guidelines and reimbursement practices; complex and ex-
panding regulatory requirements; and intellectual property protection. (See “Item 1. Business” and “Item 1A.
Risk Factors” for further information on these economic and industry-wide factors and their impact and potential
impact on our business.)
Results of Operations
Product sales
For the years ended December 31, 2007, 2006 and 2005, worldwide product sales and total product sales by
geographic region were as follows (dollar amounts in millions):
2007 Change 2006 Change 2005
Aranesp®.............................. $ 3,614 (12)% $ 4,121 26% $ 3,273
EPOGEN®............................. 2,489 (1)% 2,511 2% 2,455
Neulasta®/NEUPOGEN®................. 4,277 9% 3,923 12% 3,504
ENBREL .............................. 3,230 12% 2,879 12% 2,573
Sensipar®.............................. 463 44% 321 104% 157
Vectibix™ ............................. 170 336% 39 n/a —
Other ................................. 68 6% 64 7% 60
Total product sales .................... $14,311 3% $13,858 15% $12,022
Total U.S. ............................. $11,443 0% $11,397 15% $ 9,892
Total International ....................... 2,868 17% 2,461 16% 2,130
Total product sales .................... $14,311 3% $13,858 15% $12,022
Product sales are influenced by a number of factors, including demand, third-party reimbursement avail-
ability and policies, government programs, regulatory developments or guidelines, clinical trial outcomes,
clinical practice, pricing strategies, wholesaler and end-user inventory management practices, patient population,
fluctuations in foreign currency exchange rates, new product launches and indications, competitive products,
product supply and acquisitions. (See “Item 1. Business — Principal Products” for a discussion of our principal
products and their approved indications.)
Sales growth in 2007 was principally driven by ENBREL and Neulasta®sales, which was substantially off-
set by a decline in Aranesp®sales. In particular for the year ended December 31, 2007, U.S. Aranesp®sales
declined 23%, primarily reflecting a decrease in demand resulting from recent regulatory and reimbursement de-
velopments as discussed in more detail below. Sales growth in 2006 was principally driven by demand for
Aranesp®, Neulasta®and ENBREL, which benefited from share gains and/or market growth. International prod-
uct sales growth in 2007 was favorably impacted by $193 million and unfavorably impacted by $13 million in
2006 from foreign currency exchange rate changes. Excluding the impact of foreign currency exchange rate
changes, international product sales increased 9% and 16% in 2007 and 2006, respectively.
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