Amgen 2011 Annual Report Download - page 72

could result in a mandated withdrawal of our products from the market. This could negatively impact our ability
to satisfy demand for our products, which could materially and adversely affect our product sales, business and
operating results. Further, any disruptions or delays by us or by third-party suppliers or partners in converting to
alternatives to certain biologically derived substances and alternative manufacturing processes or our ability to
gain regulatory approval for the alternative materials and manufacturing processes could increase our associated
costs or result in the recognition of an impairment in the carrying value of certain related assets, which could
have a material and adverse effect on our business and results of operations.
Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product
sales.
Manufacturing biologic human therapeutic products is difficult, complex and highly regulated. We currently
manufacture all of our principal products and plan to manufacture many of our product candidates. In addition,
we currently use third-party contract manufacturers to produce or assist in the production of ENBREL, Prolia®,
Sensipar®/Mimpara®, Nplate®, XGEVA®and Vectibix®and plan to use contract manufacturers to produce or
assist in the production of a number of our late-stage product candidates. Our ability to adequately and timely
manufacture and supply our products is dependent on the uninterrupted and efficient operation of our facilities
and those of our third-party contract manufacturers, which may be impacted by:
• availability or contamination of raw materials, components and equipment used in the manufacturing
process, particularly those for which we have no other source or supplier;
• capacity of our facilities and those of our contract manufacturers;
• contamination by microorganisms or viruses;
• natural or other disasters, including hurricanes, earthquakes, volcanoes or fires;
• labor disputes or shortages, including the effects of a pandemic flu outbreak, natural disaster, or
otherwise;
• degree of compliance with regulatory requirements;
• changes in forecasts of future demand;
• timing and actual number of production runs;
• updating of manufacturing specifications;
• production success rates and yields; and
• timing and outcome of product quality testing.
If the efficient manufacture and supply of our products is interrupted, we may experience delayed
shipments, supply constraints, stock-outs and/or recalls of our products. For example, over the past several years
we have initiated a number of voluntary recalls of certain lots of our products. (See Our current products and
products in development cannot be sold if we do not maintain or gain regulatory approval.) 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, business 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, validate and license a new manufacturing plant
and it can take longer than three years to qualify and license a new contract manufacturer. For example, in order
to maintain supply and to satisfy anticipated future demand for denosumab, we are qualifying the expansion of
our existing bulk protein facilities at our Puerto Rico site. In addition, in order mitigate the risk associated with
the majority of our formulation and fill operations being performed in a single facility, we are completing the
construction and qualification of a new formulation and filling facility at our Puerto Rico site, and are modifying
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