Eli Lilly 2010 Annual Report Download - page 23

FORM 10-K
Available Information on Our Web Site
We make available through our company web site, free of charge, our company filings with the Securities and
Exchange Commission (SEC) as soon as reasonably practicable after we electronically file them with, or furnish
them to, the SEC. These include our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K, proxy statements, registration statements, and any amendments to those documents. The company
web site link to our SEC filings is http://investor.lilly.com/sec.cfm.
In addition, the Corporate Governance portion of our web site includes our corporate governance guidelines, board
and committee information (including committee charters), and our articles of incorporation and by-laws. The link to
our corporate governance information is http://investor.lilly.com/governance.cfm.
We will provide paper copies of our SEC filings free of charge upon request to the company’s secretary at the
address listed on the front of this Form 10-K.
Item 1A. Risk Factors; Cautionary Statement Regarding Forward
Looking Statements
In addition to the other information contained in this Form 10-K, the following risk factors should be considered
carefully in evaluating our company. It is possible that our business, financial condition, liquidity, or results of
operations could be materially adversely affected by any of these risks.
We make certain forward-looking statements in this Form 10-K, and company spokespersons may make such
statements in the future. Where possible, we try to identify forward-looking statements by using such words as
“expect,” “plan,” “will,” “estimate,” “forecast,” “project,” “believe,” and “anticipate”. Forward-looking statements do
not relate strictly to historical or current facts. They are likely to address our growth strategy, sales of current and
anticipated products, financial results, our research and development programs, the status of product approvals,
legislative and regulatory developments, and the outcome of contingencies such as litigation and investigations. All
forward-looking statements are based on our expectations at the time we make them. They are subject to risks and
uncertainties, including those summarized below.
•Pharmaceutical research and development is very costly and highly uncertain. There are many difficulties and
uncertainties inherent in pharmaceutical research and development and the introduction of new products.
There is a high rate of failure inherent in new drug discovery and development. To bring a drug from the
discovery phase to market typically takes a decade or more and costs over $1 billion. Failure can occur at any
point in the process, including late in the process after substantial investment. As a result, most funds invested
in research programs will not generate financial returns. New product candidates that appear promising in
development may fail to reach the market or may have only limited commercial success because of efficacy or
safety concerns, inability to obtain necessary regulatory approvals, limited scope of approved uses, difficulty or
excessive costs to manufacture, or infringement of the patents or intellectual property rights of others. Delays
and uncertainties in the FDA approval process and the approval processes in other countries can result in
delays in product launches and lost market opportunity. In recent years, FDA review times have increased
substantially and fewer new drugs are being approved. In addition, it can be very difficult to predict sales growth
rates of new products.
•We face intense competition. We compete with a large number of multinational pharmaceutical companies,
biotechnology companies and generic pharmaceutical companies. To compete successfully, we must continue
to deliver to the market innovative, cost-effective products that meet important medical needs. Our product
sales can be adversely affected by the introduction by competitors of branded products that are perceived as
superior by the marketplace, by generic versions of our branded products, and by generic versions of other
products in the same therapeutic class as our branded products. See Item 1, “Business—Competition,” for
more details.
•Our long-term success depends on intellectual property protection. Our long-term success depends on our
ability to continually discover, develop, and commercialize innovative new pharmaceutical products. Without
strong intellectual property protection, we would be unable to generate the returns necessary to support the
enormous investments in research and development and capital as well as other expenditures required to bring
new drugs to the market.
Intellectual property protection varies throughout the world and is subject to change over time. In the U.S., the
Hatch-Waxman Act provides generic companies powerful incentives to seek to invalidate our patents; as a
result, we expect that our U.S. patents on major products will be routinely challenged, and there can be no
assurance that our patents will be upheld. See Item 1, “Business—Patents, Trademarks, and Other Intellectual
Property Protection,” for more details. We are increasingly facing generic manufacturer challenges to our
patents outside the U.S. as well. In addition, competitors or other third parties may claim that our activities
infringe patents or other intellectual property rights held by them. If successful, such claims could result in our
being unable to market a product in a particular territory or being required to pay damages for past
infringement or royalties on future sales. See Item 1, “Business—Patents, Trademarks, and Other Intellectual
Property Protection,” for more details.
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