Amgen 2009 Annual Report Download - page 64

• production success rates and bulk drug yields
• timing and outcome of product quality testing
If the efficient manufacture and supply of our products is interrupted, we may experience delayed ship-
ments, supply constraints, stock-outs and/or recalls of our products. If we are at any time unable to provide an
uninterrupted supply of our products to patients, we may lose patients and physicians may elect to prescribe
competing therapeutics instead of our products, which could materially and adversely affect our product sales
and results of operations.
Our manufacturing processes and those of our third-party contract manufacturers must undergo a potentially
lengthy FDA or other regulatory approval process and are subject to continued review by the FDA and other
regulatory authorities. It can take longer than five years to build and license a new manufacturing plant and it can
take longer than three years to qualify and license a new contract manufacturer. In order to maintain supply,
mitigate risks associated with the majority of our formulation, fill and finish operations being performed in a sin-
gle facility and to satisfy anticipated demand for our late-stage product candidates, in particular denosumab, we
must successfully implement certain manufacturing projects on schedule.
If regulatory authorities determine that we or our third-party contract manufacturers or certain of our third-
party service providers have violated regulations or if they restrict, suspend or revoke our prior approvals, they
could prohibit us from manufacturing our products or conducting clinical trials or selling our marketed products
until we or the affected third-party contract manufacturers or third-party service providers comply, or indef-
initely. Because our third-party contract manufacturers and certain of our third-party service providers are subject
to the FDA and foreign regulatory authorities, alternative qualified third-party contract manufacturers and third-
party service providers may not be available on a timely basis or at all. If we or our third-party contract
manufacturers or third-party service providers cease or interrupt production or if our third-party contract manu-
facturers and third-party service providers fail to supply materials, products or services to us, we may experience
delayed shipments, supply constraints, stock-outs and/or recalls of our products. Additionally, we distribute a
substantial volume of our commercial products through a single distribution center in Louisville, Kentucky for
the United States and another in Breda, the Netherlands for Europe and the rest of the world. Our ability to timely
supply products is dependent on the uninterrupted and efficient operations of our distribution and logistics cen-
ters and our third-party logistics providers.
We manufacture and formulate, fill and finish substantially all our products at our Puerto Rico manufactur-
ing facility; if significant natural disasters or production failures occur at this facility, we may not be able
to supply these products.
We currently perform all of the formulation, fill and finish for EPOGEN®, Aranesp®, Neulasta®and NEUP-
OGEN®, and substantially all of the formulation, fill and finish operations for ENBREL, and all of the bulk
manufacturing for Aranesp®, Neulasta®and NEUPOGEN®at our manufacturing facility in Juncos, Puerto Rico.
In addition if denosumab is approved by the FDA, it will be primarily produced at the Puerto Rico facility. Our
global supply of these products is significantly dependent on the uninterrupted and efficient operation of this fa-
cility. A number of factors could adversely affect our operations, including:
• power failures and/or other utility failures
• breakdown, failure or substandard performance of equipment
• improper installation or operation of equipment
• labor disputes or shortages, including the effects of a pandemic flu outbreak
• inability or unwillingness of third-party suppliers to provide raw materials and components
• natural or other disasters, including hurricanes
• failures to comply with regulatory requirements, including those of the FDA
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