Amgen 2009 Annual Report Download - page 85

related to a shift of ENBREL to a wholesaler distribution model, partially offset by an increase in demand. The
increase in demand was driven by a mid-single digit increase in the average net sales price partially offset by a
decline in units sold due to share declines as a result of competitive activity. ENBREL continues to maintain a
leading position in both the rheumatology and dermatology segments.
ENBREL sales growth for the year ended December 31, 2008 reflects higher demand principally due to in-
creases in the average net sales price. ENBREL sales were also favorably impacted by approximately $100
million due to a change in our distribution model for ENBREL. Previously, ENBREL was shipped directly to
pharmacies. However, beginning in the three months ended March 31, 2008, we commenced using a wholesaler
distributor model, similar to our other marketed products. Also, ENBREL sales growth for the year ended De-
cember 31, 2008 was affected by share declines in the rheumatology and dermatology segments in the United
States compared to the prior year due to increased competitive activity. However, sales growth continued in both
rheumatology and dermatology.
In addition to other factors mentioned in the “Product sales” section above, future ENBREL sales will be
dependent, in part, on such factors as:
• the effects of competing products or therapies, including new competitive products coming to market,
such as Centocor Ortho Biotech’s Simponi™(golimumab) and Stelara™(ustekinumab) and UCB/Nektar
Therapeutics’ Cimzia®(PEGylated anti-TNF alpha) (see “Item 1. Business — Marketed Products and Se-
lected Product Candidates”) and, in part, our ability to differentiate ENBREL based on a combination of
its safety profile and efficacy;
• proposed healthcare reform in the United States;
• severity and duration of the current global economic downturn;
• the availability, extent and access to reimbursement by government and third-party payers;
• future product label changes;
• risk management activities, including the proposed modification to our REMS, undertaken by us or re-
quired by the FDA or other regulatory authorities;
• growth in the rheumatology and dermatology segments;
• adverse events or results from clinical trials, including sub-analyses, studies or meta-analyses performed
by us or by others (including our licensees or independent investigators), which could impact product
safety labeling and may 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;
• cost containment pressures from governments and private insurers on healthcare providers;
• our contracting and related pricing strategies; and
• patient population growth.
See “Item 1A. Risk Factors” for further discussion of certain of the above factors that could impact our fu-
ture product sales.
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