Isis Pharmaceuticals, Inc. Form 10K - page 54

PATRICKR. O’NEIL, Esq.
Senior Vice President, Legal and General Counsel
Mr. O’Neil was promoted to Senior Vice President, Legal and General Counsel in January 2013. Starting in
January 2015, Mr. O’Neil also serves as our Corporate Secretary. FromSeptember 2010 to January 2013, Mr.
O’Neil served as our Vice President, Legal and General Counsel and from January 2009 to September 2010, he
served as our Vice President, Legal and Senior Transactions Counsel. FromOctober 2001 to January 2009 he
held various positions within our Legal department. Prior to joining Isis, Mr. O’Neil was an associate at Cooley
LLP.
Item1A.RISKFACTORS
Investing in our securities involves a high degree of risk. You should consider carefully the following
information about the risks described below, together with the other information contained in this report and in
our other public filings in evaluating our business. If any of the following risks actually occur, our business
could be materially harmed, and our financial condition and results of operations could be materially and
adversely affected. As a result, the trading price of our securities could decline, and you might lose all or part of
your investment.
Risks Associated with our Drug Discovery and Development Business
If the market does not accept KYNAMRO and our other drugs, including ISIS-APOCIIIRx, ISIS-SMNRx
and ISIS-TTRRx, we are not likely to generate revenues or become consistently profitable.
Even though KYNAMRO is approved for HoFH in the United States, and if any of our other drugs are
approved for marketing, including ISIS-APOCIIIRx, ISIS-SMNRx and ISIS-TTRRx, our success will depend upon
the medical community, patients and third party payors accepting our drugs as medically useful, cost-effective
and safe. Even when the FDAor foreign regulatory authorities approve our or our partners’ drugs for
commercialization, doctors may not prescribe our drugs to treat patients. We and our partners may not
successfully commercialize additional drugs.
In particular, even though KYNAMRO is approved for HoFH in the United States, it may not be
commercially successful.
Additionally, in many of the markets where we may sell our drugs in the future, if we cannot agree with the
government regarding the price we can charge for our drugs, then we may not be able to sell our drugs in that
market.
The degree of market acceptance for KYNAMRO, and any of our other drugs, including ISIS-APOCIIIRx,
ISIS-SMNRx and ISIS-TTRRx, depends upon a number of factors, including the:
• receipt and scope of regulatory approvals;
• establishment and demonstration in the medical and patient community of the efficacy and safety of our
drugs and their potential advantages over competing products;
• cost and effectiveness of our drugs compared to other available therapies;
• patient convenience of the dosing regimen for our drugs; and
• reimbursement policies of government and third-party payors.
Based on the profile of our drugs, physicians, patients, patient advocates, payors or the medical community
in general may not accept and/or use any drugs that we may develop. In addition, cost control initiatives by
governments or third party payors could decrease the price received for KYNAMRO or our other drugs or
increase patient coinsurance to a level that makes KYNAMRO or our other drugs, including ISIS-APOCIIIRx,
ISIS-SMNRx and ISIS-TTRRx, unaffordable.
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