Amgen 2009 Annual Report Download - page 77

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Forward looking statements
This report and other documents we file with the SEC contain forward looking statements that are based on
current expectations, estimates, forecasts and projections about us, our future performance, our business or others
on our behalf, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make
forward looking statements in press releases or written statements, or in our communications and discussions
with investors and analysts in the normal course of business through meetings, webcasts, phone calls and confer-
ence calls. Words such as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,”
“believe,” “seek,” “estimate,” “should,” “may,” “assume,” “continue,” variations of such words and similar ex-
pressions are intended to identify such forward looking statements. These statements are not guarantees of future
performance and involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our
respective risks, uncertainties and assumptions that could affect the outcome or results of operations in “Item 1A.
Risk Factors.” We have based our forward looking statements on our management’s beliefs and assumptions
based on information available to our management at the time the statements are made. We caution you that ac-
tual outcomes and results may differ materially from what is expressed, implied or forecast by our forward
looking statements. Reference is made in particular to forward looking statements regarding product sales, regu-
latory activities, clinical trial results, reimbursement, expenses, earnings per share (“EPS”), liquidity and capital
resources and trends. Except as required under the federal securities laws and the rules and regulations of the
SEC, we do not have any intention or obligation to update publicly any forward looking statements after the dis-
tribution of this report, whether as a result of new information, future events, changes in assumptions or
otherwise.
Overview
The following management’s discussion and analysis (“MD&A”) is intended to assist the reader in under-
standing Amgen’s business. MD&A is provided as a supplement to, and should be read in conjunction with, our
consolidated financial statements and accompanying notes. Our results of operations discussed in MD&A are
presented in conformity with accounting principles generally accepted in the United States (“GAAP”).
We are the largest independent biotechnology medicines company. We discover, develop, manufacture and
market medicines for grievous illnesses. We concentrate on innovative novel medicines based on advances in
cellular and molecular biology. Our mission is to serve patients. We operate in one business segment — human
therapeutics. Therefore, our results of operations are discussed on a consolidated basis.
We operate in a highly regulated industry and various U.S. and foreign regulatory bodies have substantial
authority over how we conduct our business. Government authorities in the United States and in other countries
regulate the manufacturing and marketing of our products and our ongoing R&D activities. The regulatory envi-
ronment is evolving and there is increased scrutiny on drug safety and increased authority being granted to
regulatory bodies, in particular the FDA, to assist in ensuring the safety of therapeutic products, which may lead
to fewer products being approved by the FDA or other regulatory bodies, delays in receiving approvals or addi-
tional safety-related requirements or restrictions on the use of our products, including expanded safety labeling,
required risk management activities, including a REMS, and/or additional or more extensive clinical trials as part
of PMCs, PMRs or a pharmacovigilance program. This is increasingly true of new therapies with novel mecha-
nisms of action. While these therapies may offer important benefits and/or better treatment alternatives, they may
also involve a relatively new or higher level of scientific complexity and, therefore, generate increased safety
concerns.
Most patients receiving our principal products for approved indications are covered by either government or
private payer healthcare programs, which are placing greater emphasis on cost containment, including requiring
that the economic value of products be clearly demonstrated. Governments may regulate access to, prices or re-
imbursement levels of our products to control costs or to affect levels of use of our products and private insurers
may be influenced by government reimbursement methodologies. Worldwide use of our products may be af-
fected by these cost containment pressures and cost shifting from governments and private insurers to healthcare
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