As of December 31, 2014, we had an accumulated deficit of approximately $1.0 billion and stockholders’ equity
of approximately $257.8 million. Most of the losses resulted from costs incurred in connection with our research
and development programs and from general and administrative costs associated with our operations. Most of our
revenue has come from collaborative arrangements, with additional revenue from research grants and the sale or
licensing of our patents, as well as interest income. We may incur additional operating losses over the next
several years, and these losses may increase if we cannot increase or sustain revenue. We may not successfully
develop any additional products or achieve or sustain future profitability.
Since corporate partnering is a key part of our strategy to fund the development and commercialization of
our development programs, if any of our collaborative partners fail to fund our collaborative programs, or
if we cannot obtain additional partners, we may have to delay or stop progress on our drug development
programs.
To date, corporate partnering has played a key role in our strategy to fund our development programs and to
add key development resources. We plan to continue to rely on additional collaborative arrangements to develop
and commercialize our unpartnered drugs. However, we may not be able to negotiate favorable collaborative
arrangements for these drug programs. If we cannot continue to secure additional collaborative partners, our
revenues could decrease and the development of our drugs could suffer.
Our corporate partners are developing and/or funding many of the drugs in our development pipeline. If any
of these pharmaceutical companies stops developing and/or funding these drugs, our business could suffer and
we may not have, or be willing to dedicate, the resources available to develop these drugs on our own.
Our collaborators can terminate their relationships with us under certain circumstances, many of which are
outside of our control. In the past, based on the disappointing results of Phase 3 clinical studies, we had a partner
discontinue its investment in one of our drugs.
Even with funding from corporate partners, if our partners do not effectively perform their obligations
under our agreements with them, it would delay or stop the progress of our drug development programs.
In addition to receiving funding, we enter into collaborative arrangements with third parties to:
•
conduct clinical studies;
•
seek and obtain regulatory approvals; and
•
manufacture, market and sell our drugs.
Once we have secured a collaborative arrangement to further develop and commercialize one of our drug
development programs, such as our collaborations withAstraZeneca, Biogen Idec, Genzyme, GSK, and Roche
these collaborations may not continue or result in commercialized drugs, or may not progress as quickly as we
first anticipated.
For example, a collaborator such as AstraZeneca, Biogen Idec, Genzyme, GSK, or Roche, could determine
that it is in its financial interest to:
•
pursue alternative technologies or develop alternative products that may be competitive with the drug
that is part of the collaboration with us;
•
pursue higher-priority programs or change the focus of its own development programs; or
•
choose to devote fewer resources to our drugs than it does for its own drugs.
If any of these occur, it could affect our partner’s commitment to the collaboration with us and could delay
or otherwise negatively affect the commercialization of our drugs, including KYNAMRO, ISIS-APOCIII
Rx
,
ISIS-SMN
Rx
and ISIS-TTR
Rx
.
If we do not progress in our programs as anticipated, the price of our securities could decrease.
For planning purposes, we estimate and may disclose the timing of a variety of clinical, regulatory and other
milestones, such as when we anticipate a certain drug will enter the clinic, when we anticipate completing a
clinical study, or when we anticipate filing an application for marketing approval. We base our estimates on
present facts and a variety of assumptions. Many underlying assumptions are outside of our control. If we do not
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