Amgen 2007 Annual Report Download - page 60

Our success depends in part on our ability to obtain and defend patent rights and other intellectual property
rights that are important to the commercialization of our products and product candidates. We have filed applica-
tions for a number of patents and have been granted patents or obtained rights relating to erythropoietin, natural
and recombinant G-CSF, darbepoetin alfa, pegfilgrastim, etanercept, cinacalcet HCl, panitumumab and our other
products and potential products. We market our erythropoietin, recombinant G-CSF, darbepoetin alfa, pegfil-
grastim, etanercept, cinacalcet HCl and panitumumab products as EPOGEN®(Epoetin alfa), NEUPOGEN®
(Filgrastim), Aranesp®(darbepoetin alfa), Neulasta®(pegfilgrastim), Enbrel®(etanercept), Sensipar®/Mimpara®
(cinacalcet HCl) and VectibixTM (panitumumab), respectively. With respect to our material patents, we have had
a number of G-CSF patent expiries in the United States.
We also have been granted or obtained rights to patents in Europe relating to erythropoietin; G-CSF; pegfil-
grastim (pegylated G-CSF); etanercept; two relating to darbepoetin alfa; hyperglycosylated erythropoietic
proteins; and cinacalcet HCl. Our principal European patent relating to erythropoietin expired on December 12,
2004 and our principal European patent relating to G-CSF expired on August 22, 2006. As these patents have
expired, some companies have and we believe others may receive approval for and market biosimilar and other
products (as they are generally known in the EU) to compete with these products in the EU presenting additional
competition to our products. (See “— Our marketed products face substantial competition and other companies
may discover, develop, acquire or commercialize products before or more successfully than we do.”)
We may experience difficulties, delays or unexpected costs and not achieve anticipated cost savings from
our recently announced restructuring plan.
As a result of recent developments and, in particular the regulatory and reimbursement changes to our mar-
keted ESA products, on August 15, 2007, we announced a plan to restructure 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 the restructuring plan, we reduced staff, made changes to certain capital projects
and closed certain production operations. As a result of our restructuring plan, we expect to reduce costs begin-
ning in 2008. Our ability to achieve anticipated savings is dependent upon various future developments, some of
which are beyond our control. We may also not realize, in full or in part, the anticipated benefits and savings
from our restructuring efforts due to unforeseen difficulties, delays or unexpected costs. If we are unable to
achieve the anticipated savings or benefits to our business in the expected time frame or other unforeseen events
occur, our business and results of operations may be adversely affected. Further, if we were to experience un-
anticipated and unforeseen changes to our business, we may face further restructuring and/or reorganization
activities in the future.
In addition, our reduction of staff was completed through a combination of a voluntary transition program
and an involuntary reduction in force. In order to be successful and build our framework for future growth, we
must continue to execute and deliver on our core business initiatives, with fewer human resources and losses of
intellectual capital. We must also attract, retain and motivate key employees including highly qualified manage-
ment, scientific, manufacturing and sales and marketing personnel who are critical to our business. We may not
be able to attract, retain or motivate qualified employees in the future and our inability to do so may adversely af-
fect 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. (See “— Our sales depend on payment and reimbursement from third-party payers, and, to
the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our
products.”) Organizations like these have in the past made recommendations about our products. Recom-
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