Amgen 2007 Annual Report Download - page 66

we are at any time unable to provide an uninterrupted supply of our products to patients, we may lose patients,
physicians may elect to prescribe competing therapeutics instead of our products, and sales of our products will
be adversely affected, which could materially and adversely affect our product sales and results of operations.
We manufacture and contract manufacture, price, sell, distribute and market or co-market our products for
their approved indications. These activities are subject to extensive regulation by numerous state and federal
governmental authorities in the United States, such as the FDA and CMS, as well as in foreign countries, includ-
ing European countries, Canada, Australia and Japan. Although we have obtained regulatory approval for our
marketed products, these products and our manufacturing processes and those of our third-party contract manu-
facturers 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 li-
cense a new manufacturing plant and it can take longer than three years to qualify a new contract manufacturer.
In order to maintain supply, mitigate risks associated with the vast majority of our formulation, fill and finish op-
erations being performed in a single facility and to adequately prepare to launch a number of our late-stage
product candidates, we must successfully implement a number of manufacturing projects on schedule, operate
our facilities at appropriate production capacity over the next few years, continue our use of third-party contract
manufacturers and maintain a state of regulatory compliance. Key manufacturing projects include: (i) expansion
of our existing bulk protein facilities at our Puerto Rico site for the production of our late-stage product candidate
denosumab; (ii) construction, qualification and licensure of a new formulation and filling facility at our Puerto
Rico site and (iii) expansion of our Fremont, California facility to support future product launches.
If regulatory authorities determine that we or our third-party contract manufacturers or 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 our
third-party contract manufacturers or third-party service providers comply, or indefinitely. Because our third-
party contract manufacturers and third-party service providers are subject to FDA and foreign regulatory
authorities, alternative qualified third-party contract manufacturers and service providers may not be available on
a timely basis or at all. For example, we are dependent upon a single FDA approved third-party contract manu-
facturer for the formulation, fill and finish of VectibixTM. If we or our third-party contract manufacturers and
third-party service providers cease or interrupt production or if our third-party contract manufacturers and third-
party service providers fail to supply materials, products or services to us for any reason, we may experience
delayed shipments, supply constraints, stock-outs and/or recalls of our products. If we are unable to manufacture,
market and sell our products, our business and results of operations would be materially and adversely affected.
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®, some 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. Our global supply
of these products is significantly dependent on the uninterrupted and efficient operation of this facility. A number
of factors could adversely affect our operations, including:
• power failures
• breakdown, failure or substandard performance of equipment
• improper installation or operation of equipment
• labor disputes or shortages, including the effects of an avian or pandemic flu outbreak, or otherwise
• inability 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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