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We monitor events and expectations regarding
product performance. If new information indicates that
the assumptions underlying our most recent analysis
are substantially different than those utilized in our
current estimates, our analysis would be updated and
may result in a significant change in the anticipated
lifetime revenues of the relevant products. The
occurrence of an adverse event could substantially
increase the amount of amortization expense
associated with our acquired intangible assets as
compared to previous periods or our current
expectations, which may result in a significant
negative impact on our future results of operations.
For 2017 compared to 2016, the increase in
amortization of acquired
intangible assets was
primarily due to $444.2 million of amortization and
impairment charges associated with our U.S. and rest
of world licenses to Forward Pharma's
intellectual
property, including Forward Pharma's intellectual
property related to TECFIDERA, acquired in the first
quarter of 2017, as discussed further below.
Amortization of acquired intangible assets for 2017
also reflects the $31.2 million impairment of our
acquired and in-licensed rights and patents intangible
asset related to the Article 20 Procedure of
ZINBRYTA.
For additional information on the Article 20
Procedure of ZINBRYTA and resulting impairment of
ZINBRYTA related assets, please read Note 20,
Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.
For 2016 compared to 2015, amortization of
acquired intangible assets
was relatively consistent
as our most recent analysis completed during the
third quarter of 2016 resulted in no significant net
change in our expected rate of amortization for
acquired intangible assets. Amortization of acquired
intangible assets for 2016 also reflects impairment
charges recognized upon the termination of our
collaboration agreements with Rodin Therapeutics,
Inc. and Ataxion Inc., which resulted in impairment
losses of $8.7 million and $3.5 million, respectively,
related to the IPR&D assets recorded upon entering
into the collaboration agreements.
Impairment charges related to intangible assets
during 2015 were insignificant.
TECFIDERA License Rights
In January 2017 we entered into a settlement
and license agreement with Forward Pharma.
Pursuant to this agreement, we obtained U.S. and
rest of world licenses to Forward Pharma's intellectual
property, including Forward Pharma's intellectual
property related to TECFIDERA. In exchange, we paid
Forward Pharma $1.25 billion in cash. During the
fourth quarter of 2016, we recognized a pre-tax
charge of $454.8 million and in the first quarter of
2017 we recognized an intangible asset of $795.2
million related to this agreement. The pre-tax charge
recognized in the fourth quarter of 2016 represented
the fair value of our licenses to Forward Pharma’s
intellectual property for the period April 2014, when
we started selling TECFIDERA, through December 31,
2016. The intangible asset represented the fair value
of the U.S. and rest of world licenses to Forward
Pharma’s intellectual property related to TECFIDERA
revenues for the period January 2017, the month in
which we entered into this agreement, through
December 2020, the
last month before royalty
payments could first commence pursuant to this
agreement.
We have two intellectual property disputes with
Forward Pharma, one in the U.S. and one in the E.U.,
concerning intellectual property related to TECFIDERA.
In March 2017 the U.S. intellectual property dispute
was decided in our favor. Forward Pharma appealed to
the U.S. Court of Appeals for the Federal Circuit and
the appeal is pending. We evaluated the recoverability
of the U.S. asset acquired from Forward Pharma and
recorded an impairment charge in the first quarter of
2017 to adjust the carrying value of the acquired U.S.
asset to fair value reflecting the impact of the
developments in the U.S. legal dispute. In January
2018 the EPO announced its decision revoking
Forward Pharma’s European Patent No. 2 801 355.
Forward Pharma has stated that it expects to file an
appeal to the Technical Board of Appeal of the EPO.
Based upon our assessment of these rulings, we
continue to amortize the
remaining net book value of
the U.S. and rest of world intangible assets in our
consolidated statements of income utilizing an
economic consumption model.
For additional information on our settlement and
license agreement with Forward Pharma and related
intangible assets, please read Note 7, Intangible
Assets and Goodwill, to our consolidated financial
statements included in this report. For additional
information on these disputes, please read Note 21,
Litigation, to our consolidated financial statements
included in this report.
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In Process Research & Development (IPR&D) related
to Business Combinations
Overall, the value of our acquired IPR&D assets
is dependent
upon a number of variables, including
estimates of future revenues and the effects of
competition, the level of anticipated development
costs and the probability and timing of successfully
advancing a particular research program from a
clinical trial phase to the next. We are continually
reevaluating our estimates concerning these variables
and evaluating industry data regarding the productivity
of clinical research and the development
process. Changes in our estimates of items may
result in a significant change to our valuation of these
assets.
We review amounts capitalized as acquired
IPR&D for impairment at least annually, as of October
31, and whenever
events or changes in
circumstances indicate to us that the carrying value of
the assets might not be recoverable. Our most recent
impairment assessment as of October 31, 2017,
resulted in no impairments. Changes to clinical
development plans, regulatory feedback received, life
cycle management strategies and changes in program
economics, including foreign currency exchange rates,
are evaluated regularly. The field of developing
treatments for forms of neuropathic pain, such as
TGN, is highly competitive and can be affected by
changes to expected market candidates and changes
in timing and the clinical development of our product
candidates. There can be no assurance that we will
be able to successfully develop BIIB074 for the
treatment
of TGN or other indications, including our
ability to confirm safety and efficacy based on data
from clinical trials, or that a successfully developed
therapy will be able to secure sufficient pricing in a
competitive market. Changes in events and
circumstances for these programs may have a
material impact on the value of our related IPR&D.
For additional information on the impairment and
amortization of acquired intangible assets, including
our TECFIDERA settlement and license agreement,
please read Note 7, Intangible Assets and Goodwill, to
our consolidated financial statements included in this
report.
Acquired In-Process Research and Development
In May 2017 we completed an asset purchase of
the Phase 3-ready
candidate, BIIB093, from Remedy.
In connection with the closing of this transaction, we
made an upfront $120.0 million payment to Remedy,
which was recorded as acquired in-process research
and development in our consolidated statements of
income as BIIB093 had not yet reached technological
feasibility. For additional information on our
transaction with Remedy, please read Note 2,
Acquisitions, to our consolidated financial statements
included in this report.