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PATRICKR.O’NEIL, Esq.
Senior VicePresident, Legal andGeneral Counsel
Mr. O’Neilwas promoted toSeniorVicePresident, Legal andGeneral Counsel in January2013. FromSeptember 2010 to
January2013,Mr. O’Neil served as ourVicePresident, Legal andGeneral Counsel and from January2009 toSeptember 2010, he
served as ourVicePresident, Legal andSenior TransactionsCounsel. FromOctober 2001 to January 2009 he heldvarious positions
withinour Legal department. Prior to joining Isis,Mr. O’Neil was an associate at CooleyLLP.
Item1A. RiskFactors
Investing inour securities involves ahighdegree of risk. You should consider carefully the following informationabout the
risks describedbelow, togetherwith the other information contained in this report and inour other public filings in evaluatingour
business. If any of the following risks actually occur, our business couldbematerially harmed, andour financial conditionand
results of operations couldbematerially andadversely affected. As a result, the tradingprice of our securities coulddecline, and you
might lose all or part of your investment.
RisksAssociatedwithourDrugDiscoveryandDevelopment Business
If themarket does not acceptKYNAMRO or our other drugs, including ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and ISIS-TTR
Rx
, we
are not likely to generate revenues or become consistentlyprofitable.
Even thoughKYNAMRO is approved forHoFH in theUnitedStates, and if anyof our other drugs are approved for
marketing, including ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and ISIS-TTR
Rx,
our successwill dependupon themedical community, patients
and thirdpartypayors accepting our drugs asmedically useful, cost-effective and safe. Evenwhen the FDA or foreign regulatory
authorities approve our or our partners’ drugs for commercialization, doctorsmaynot use our drugs to treat patients.We andour
partnersmaynot successfully commercialize additional drugs.
In particular, even thoughKYNAMRO is approved forHoFH in theUnitedStates itmay not be commercially successful.
Additionally, inmanyof themarketswherewemay sell our drugs in the future, ifwe cannot agreewith the government
regarding the pricewe can charge for our drugs, thenwemaynot be able to sell our drugs in thatmarket.
The degree ofmarket acceptance forKYNAMRO, and anyof our other drugs, including ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and
ISIS-TTR
Rx
, depends upon a number of factors, including the:
receipt and scope of regulatory approvals;
establishment and demonstration in themedical and patient community of the efficacy and safety of our drugs and their
potential advantages over competingproducts;
cost and effectiveness of our drugs compared toother available therapies;
patient convenience of the dosing regimen for our drugs; and
reimbursement policies of government and third-partypayors.
Basedon the profile of our drugs, physicians, patients, patient advocates, payors or themedical community in generalmay
not accept and/or use anydrugs that wemay develop. In addition, cost control initiatives bygovernments or thirdparty payors could
decrease the price received forKYNAMROor our other drugs or increase patient coinsurance to a level thatmakesKYNAMRO or
our other drugs, including ISIS-APOCIII
Rx
, ISIS-SMN
Rx
and ISIS-TTR
Rx,
unaffordable.
