Amgen 2002 Annual Report Download - page 41

Page 39
AMGEN 2002 ANNUAL REPORT
We plan to grow rapidly, and if we fail to adequately
manage that growth our business could be adversely
impacted.
We have an aggressive growth plan that includes substan-
tial and increasing investments in research and develop-
ment, sales and marketing and facilities. Our plan has a
number of risks, some of which we cannot control. For
example:
•we will need to generate higher revenues to cover a higher
level of operating expenses, and our ability to do so may
depend on factors that we do not control
•we will need to attract and assimilate a large number of
new employees
•we will need to manage complexities associated with a
larger and faster growing organization
•we will need to accurately anticipate demand for the prod-
ucts we manufacture and maintain adequate manufac-
turing capacity, and our ability to do so may depend on
factors that we do not control
Of course, there may be other risks and we cannot guar-
antee that we will be able to successfully manage these or
other risks.
Our stock price is volatile, which could adversely
affect your investment.
Our stock price, like that of other biotechnology compa-
nies, is highly volatile. For example, in the fifty-two weeks
prior to December 31, 2002, the trading price of our com-
mon stock has ranged from a high of $62.94 per share to a
low of $30.57 per share. Our stock price may be affected
by such factors as:
•clinical trial results
•adverse developments regarding the safety or efficacy of
our products
•actual or anticipated product supply constraints
•product development announcements by us or our
competitors
•regulatory matters
•announcements in the scientific and research community
•intellectual property and legal matters
•changes in reimbursement policies or medical practices
•broader industry and market trends unrelated to our
performance
In addition, if our revenues or earnings in any period
fail to meet the investment community’s expectations, there
could be an immediate adverse impact on our stock price.
Our corporate compliance program cannot guarantee
that we are in compliance with all potentially
applicable federal and state regulations.
The development, manufacturing, pricing, sales, and reim-
bursement of our products, together with our general oper-
ations, is subject to extensive federal and state regulation.
See “—Our current products and products in development
cannot be sold if we do not obtain and maintain regulatory
approval.” and “—We may be required to perform additional
clinical trials or change the labeling of our products if we
or others identify side effects after our products are on the
market.” While we have developed and instituted a corporate
compliance program based on current best practices, we
cannot assure you that we or our employees are or will be
in compliance with all potentially applicable federal and state
regulations. If we fail to comply with any of these regula-
tions a range of actions could result, including, but not
limited to, the termination of clinical trials, the failure to
approve a product candidate, restrictions on our products
or manufacturing processes, including withdrawal of our
products from the market, significant fines, or other sanc-
tions or litigation.
Our marketing of ENBREL
®
will be dependent in
part upon Wyeth.
Under the amended and restated co-promotion agreement,
we and Wyeth market and sell ENBREL
®
in the United
States and Canada. An ENBREL
®
management committee
comprised of an equal number of representatives from us
and Wyeth is responsible for overseeing the marketing and
sales of ENBREL
®
, including strategic planning, approval of
an annual marketing plan, product pricing, and establish-
ing an ENBREL
®
brand team. The ENBREL
®
brand team, with
equal representation from us and Wyeth, will prepare and
implement the annual marketing plan and will be respon-
sible for all sales activities. If Wyeth fails to market ENBREL
®
effectively or if we and Wyeth fail to coordinate our efforts
effectively, our sales of ENBREL
®
may be adversely affected.