•
competing technological and market developments, including the introduction by others of new
therapies that address our markets; and
•
the profile and launch timing of our drugs, including ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and ISIS-TTR
Rx
.
If we need additional funds, we may need to raise them through public or private financing. Additional
financing may not be available at all or on acceptable terms. If we raise additional funds by issuing equity
securities, the shares of existing stockholders will be diluted and the price, as well as the price of our other
securities, may decline. If adequate funds are not available or not available on acceptable terms, we may have to
cut back on one or more of our research, drug discovery or development programs. For example, in January
2005 we terminated the development of two lower priority drugs, ISIS 14803 and ISIS 104838. Alternatively, we
may obtain funds through arrangements with collaborative partners or others, which could require us to give up
rights to certain of our technologies or drugs.
The loss of key personnel, or the inability to attract and retain highly skilled personnel, couldmake it
more difficult to run our business and reduce our likelihood of success.
We are dependent on the principal members of our management and scientific staff. We do not have
employment agreements with any of our executive officers that would prevent them from leaving us. The loss of
our management and key scientific employees might slow the achievement of important research and
development goals. It is also critical to our success that we recruit and retain qualified scientific personnel to
perform research and development work. We may not be able to attract and retain skilled and experienced
scientific personnel on acceptable terms because of intense competition for experienced scientists among many
pharmaceutical and health care companies, universities and non-profit research institutions. In addition, failure to
succeed in clinical studies may make it more challenging to recruit and retain qualified scientific personnel.
If the price of our securities continues to be highly volatile, this couldmake it harder for you to liquidate
your investment and could increase your risk of suffering a loss.
The market price of our common stock, like that of the securities of many other biopharmaceutical
companies, has been and is likely to continue to be highly volatile. These fluctuations in our common stock price
may significantly affect the trading price of our securities. During the 12 months preceding December 31, 2014,
the market price of our common stock ranged from $22.25 to $67.12 per share. Many factors can affect the
market price of our securities, including, for example, fluctuations in our operating results, announcements of
collaborations, clinical study results, technological innovations or new products being developed by us or our
competitors, governmental regulation, regulatory approval, changes in payors’ reimbursement policies,
developments in patent or other proprietary rights, public concern regarding the safety of our drugs and general
market conditions.
We are exposed to potential product liability claims, and insurance against these claims may not be
available to us at a reasonable rate in the future or at all.
Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing,
marketing and sale of therapeutic products, including potential product liability claims related to KYNAMRO.
We have clinical study insurance coverage and commercial product liability insurance coverage. However, this
insurance coverage may not be adequate to cover claims against us, or be available to us at an acceptable cost, if
at all. Regardless of their merit or eventual outcome, products liability claims may result in decreased demand
for our drug products, injury to our reputation, withdrawal of clinical study volunteers and loss of revenues.
Thus, whether or not we are insured, a product liability claim or product recall may result in losses that could be
material.
Because we use biological materials, hazardous materials, chemicals and radioactive compounds, if we do
not comply with laws regulating the protection of the environment and health and human safety, our
business could be adversely affected.
Our research, development and manufacturing activities involve the use of potentially harmful biological
materials as well as materials, chemicals and various radioactive compounds that could be hazardous to human
health and safety or the environment. We store these materials and various wastes resulting from their use at our
61
