Amgen 2009 Annual Report Download - page 67

team, with equal representation from us and Pfizer, prepares and implements the annual marketing plan, which
includes a minimum level of financial and sales personnel commitment from each party, and is responsible for all
sales activities. If Pfizer fails to effectively deliver on its marketing commitments to us or if we and Pfizer fail to
coordinate our efforts effectively, our sales of ENBREL may be materially adversely affected.
We may be forced to undertake cost savings and/or restructuring initiatives in the future.
As a result of various regulatory and reimbursement developments that began in 2007, we completed a re-
structuring of our worldwide operations in order to improve our cost structure while continuing to make
significant R&D investments and build the framework for our future growth. As part of these actions, we reduced
staff, made changes to certain capital projects, closed certain production operations and abandoned leases primar-
ily for certain R&D facilities that will not be used in our operations. Our business continues to face a variety of
challenges. As a result, we may be forced to undertake further cost saving and/or restructuring initiatives in the
future. The current economic climate has forced many U.S. companies to cut costs in order to maintain their
competitive standing, including through restructurings and reorganizations. We have worked, and we continue to
work, to increase cost efficiencies and to reduce discretionary expenditures. The anticipated benefits of our cost
reduction initiatives are based on forecasts which could vary substantially from actual results, and we cannot
provide assurance that any such cost saving initiatives will not have a material adverse effect on our business.
Guidelines and recommendations published by various organizations can reduce the use of our products.
Government agencies promulgate regulations and guidelines directly applicable to us and to our products.
However, professional societies, practice management groups, insurance carriers, physicians, private health/
science foundations and organizations involved in various diseases from time to time may also publish guidelines
or recommendations to healthcare providers, administrators and payers, and patient communities. Recom-
mendations of government agencies or these other groups/organizations may relate to such matters as usage,
dosage, route of administration and use of related therapies and reimbursement of our products by government
and private payers. Recommendations or guidelines that are followed by patients and healthcare providers could
result in decreased use and/or dosage of our products. Some examples of agency and organizational guidelines
include:
• On July 31, 2009, the Kidney Disease: Improving Global Outcomes group (“KDIGO”) released its Clin-
ical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney
Disease-Mineral and Bone Disorder (“CKD-MBD”). The guideline includes detailed recommendations
for the diagnosis and evaluation of the three components of CKD-MBD followed by recommendations
for treatment. These recommendations could affect how healthcare providers prescribe Sensipar®for
ESRD patients. The impact of the KDIGO is guidelines on clinical practice or the use of Sensipar®is not
yet known.
• In August 2007, the National Kidney Foundation (“NKF”) distributed to the nephrology community final
updated Kidney Disease Outcomes Quality Initiative (“KDOQI”) clinical practice guidelines and clinical
practice recommendations for anemia in CKD. The NKF-KDOQI™Anemia Work Group recommended
in their 2007 Update to the NKF-KDOQI™Anemia Management Guidelines that physicians target Hb in
the range of 11 g/dL to 12 g/dL, and also stipulated that the target not be above 13 g/dL.
• In February 2007, following the reported results from our Anemia of Cancer (“AoC”) 103 Study, the
United States Pharmacopoeia Dispensing Information Drug Reference Guides removed Aranesp®in the
treatment of AoC.
Any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products
could adversely affect our product sales and operating results materially. In addition, the perception by the
investment community or stockholders that such recommendations or guidelines will result in decreased use and
dosage of our products could adversely affect the market price for our common stock.
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