Isis Pharmaceuticals, Inc. Form 10K - page 169

We are eligible to receive milestone payments and license fees fromAstraZeneca as programs advance in
development. In addition, we are eligible to receive royalties up to the low to mid-teens on any product sales of
drugs resulting from this collaboration. If AstraZeneca successfully develops ISIS-STAT3-2.5
Rx
, ISIS-AR-2.5
Rx
,
and the three drugs under the research program, we could receive substantive milestone payments of more than
$858 million, including up to $238 million for the achievement of development milestones and up to
$620 million for the achievement of regulatory milestones. We will earn the next milestone payment of
$10 million if we designate a development candidate for a cancer drug under our research programwith
AstraZeneca.
InAugust 2013, we added another collaboration programwithAstraZeneca to discover and develop an
antisense drug against an undisclosed target. AstraZeneca has the option to license a drug resulting from this
research collaboration. If AstraZeneca exercises its option, it will be responsible for all further global
development, regulatory and commercialization activities for such drug. We received a $0.8 million upfront
payment, which we are amortizing through December 2016. We are eligible to receive license fees and
substantive milestone payments of $163.2 million, including up to $45.3 million for the achievement of research
and development milestones and up to $105 million for regulatory milestones. We will earn the next $3.3 million
milestone payment if AstraZeneca selects a development candidate under this collaboration. In addition, we are
eligible to receive royalties up to the low teens on sales from any product that AstraZeneca successfully
commercializes under this collaboration program.
Our agreement withAstraZeneca will continue until the expiration of all payment obligations under the
agreement. In addition, the agreement, or any program under the agreement, may terminate early under the
following situations:
AstraZeneca may terminate the agreement or any program at any time by providing written notice to
us;
AstraZeneca may terminate the agreement or any program by providing written notice if we undergo a
change of control with a third party; and
Either we or AstraZeneca may terminate the agreement or any program by providing written notice to
the other party upon the other party’s uncured failure to perform a material obligation under the
agreement, or the entire agreement if the other party becomes insolvent.
During 2014, 2013 and 2012 we earned revenue of $27.7 million, $29.1 million and $9.3 million,
respectively, from our relationship withAstraZeneca, which represented 13 percent, 20 percent and nine percent,
respectively, of our total revenue for those periods. Our balance sheets at December 31, 2014 and 2013 included
deferred revenue of $4.4 million and $9.3 million, respectively, related to our relationship withAstraZeneca.
Biogen Idec
We have established four strategic collaborations with Biogen Idec that broaden and expand our severe and
rare disease franchise for neurological disorders.
ISIS-SMN
Rx
In January 2012, we entered into a collaboration agreement with Biogen Idec to develop and commercialize
ISIS-SMN
Rx
for the treatment of SMA. We are currently conducting a Phase 3 study evaluating ISIS-SMN
Rx
in
infants with SMAand a Phase 3 study evaluating ISIS-SMN
Rx
in children with SMA. In addition, we are
evaluating ISIS-SMN
Rx
in a Phase 2 open-label, multiple-dose, dose-escalation study in children with SMAand a
Phase 2 open-label, multiple-dose, dose-escalation study in infants with SMA. Patients from both of the Phase 2
studies continue to have access to ISIS-SMN
Rx
through open-label extension dosing. We are responsible for
completing the Phase 2 and Phase 3 trials we are currently conducting. If Biogen Idec exercises its option, it will
pay us a license fee and will assume all other global development, regulatory and commercialization
responsibilities. Biogen Idec has the option to license ISIS-SMN
Rx
. Biogen Idec may exercise this option upon
completion of and data review of the first successful Phase 2/3 trial or completion of both Phase 2/3 trials. An
amendment in December 2014 provided for additional opt-in scenarios, based on the filing or the acceptance of a
new drug application or marketing authorization application with the FDAor EMA.
We received an upfront payment of $29 million, which we are amortizing through February 2017. We are
also eligible to receive a license fee, milestone payments and royalties up to the mid-teens on any product sales
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