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Collaboration Profit (Loss) Sharing
Collaboration profit (loss) sharing includes our
partner's 50% share of the profit or loss related to
our biosimilars commercial agreement with Samsung
Bioepis and our partner's 50% share of the co-
promotion profits or losses in the E.U. and Canada
related to our collaboration agreement with AbbVie on
the commercialization of ZINBRYTA.
We began to recognize revenues on sales of
biosimilars in the first quarter of 2016. For 2017 we
shared collaboration profits and therefore recognized
net expense of $111.0 million as compared to net
expense of $15.1 million in the prior year comparative
period. The increase in profit sharing expense for the
comparative period was primarily due to increased
collaboration profits
resulting from increased
biosimilar product sales.
We began to recognize revenues on sales of
ZINBRYTA in the E.U. in the third quarter of 2016. For
2017 we recognized net expense of $1.3 million to
reflect AbbVie's 50% sharing of the net collaboration
profits in the E.U. and Canada as compared to net
income recognized of $4.9 million in the prior year
comparative period, to reflect AbbVie's 50% sharing of
the net collaboration losses in the E.U. and Canada.
The increase in profit sharing expense for the
comparative period was primarily due to increased
collaboration profits resulting from increased
ZINBRYTA product sales.
We expect that the future sales growth of
ZINBRYTA will be negatively impacted as a result of
the EC approved restrictions on the use of ZINBRYTA.
For additional information on our relationship with
AbbVie, including 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.
Loss (Gain) on Fair Value Remeasurement of
Contingent Consideration
Consideration payable for certain of our
business combinations includes future payments that
are contingent upon the occurrence of a particular
event or events. We record an obligation for such
contingent consideration payments at fair value on
the acquisition date. We then revalue our contingent
consideration obligations each reporting period.
Changes in the fair value of our contingent
consideration obligations, other than changes due to
payments, are recognized as a (gain)
loss on fair
value remeasurement of contingent consideration in
our consolidated statements of income.
The loss on fair value remeasurement of
contingent consideration for 2017 was primarily due
to the increase in the probability of achieving certain
developmental milestones based upon the
progression of the underlying clinical programs.
The loss on fair value remeasurement of
contingent consideration for 2016 was primarily due
to changes in the probability of achieving certain
developmental milestones based upon the
progression of the underlying clinical programs and
changes in the discount rate.
The loss on fair value remeasurement of
contingent consideration for 2015 was primarily due
to changes in the expected timing and probabilities of
success related to
the achievement of certain
developmental milestones and in the discount rate.
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Restructuring, Business Transformation and Other
Cost Saving Initiatives
2017 Corporate Strategy
In July 2017 we announced an updated strategic
framework to optimize the value of our MS business
while investing for the future across our core growth
areas of MS and neuroimmunology, AD and dementia,
Parkinson’s disease and movement disorders and
neuromuscular diseases including SMA and ALS. We
also plan to invest in emerging growth areas such as
pain, ophthalmology, neuropsychiatry and acute
neurology.
We expect the continued performance of our
commercial assets
and the expiration of the
contingent payments related to TECFIDERA, discussed
further in the “Contractual Obligations and Off-Balance
Sheet Arrangements” section of this report, to enable
us to invest in and build an industry leading
neuroscience pipeline. We view investment in growth
as our top priority, but also recognize the value of
opportunistically returning excess capital to
shareholders through share repurchases.
In order to deliver positive results in the near
term while investing in the next stages of our growth,
we will focus on the following strategic priorities:
• maximizing the resilience of our MS core
business;
• accelerating efforts in SMA as a significant new
growth
opportunity;
• developing and expanding our neuroscience
portfolio;
• focusing our capital allocation efforts to drive
investment for future growth; and
• creating a leaner and simpler operating model to
streamline our operations and reallocate
resources towards prioritized research and
development and commercial value creation
opportunities.
In October 2017, in connection with creating a
leaner and simpler operating model, we approved a
corporate restructuring program intended to
streamline our operations and reallocate resources.
We expect to make total non-recurring operating and
capital expenditures of up to $170.0 million, primarily
in 2018, and our goal is to redirect resources of up to
$400.0 million annually by 2020
to prioritized
research and development and other value creation
opportunities.
For the year ended December 31, 2017, we
recognized charges in our consolidated statements of
income totaling $19.4 million related to this effort, of
which $18.5 million is included in selling, general and
administrative expense and $0.9 million is reflected
as restructuring charges. These restructuring charges,
which were substantially incurred and paid in 2017,
were primarily related to severance.
2016 Organizational Changes and Cost Saving
Initiatives
2016 Restructuring Charges
During the third quarter of 2016 we initiated cost
saving measures primarily intended to realign our
organizational structure due to the changes in roles
and workforce resulting from our decision to spin-off
our hemophilia business, and
to achieve further
targeted cost reductions. For the year ended
December 31, 2016, we recognized charges totaling
$17.7 million related to this effort, which are in
addition to, and separate from, the 2015 restructuring
charges described below. These amounts, which were
substantially incurred and paid by the end of 2016,
were primarily related to severance and are reflected
in restructuring charges in our consolidated
statements of income.
Cambridge, MA Manufacturing Facility
In June 2016 following an evaluation of our
current and future manufacturing capabilities and
capacity needs, we determined that we intended to
cease manufacturing and vacate our 67,000
square
foot small-scale biologics manufacturing facility in
Cambridge, MA and close and vacate our 46,000
square foot warehouse space in Somerville, MA.
In December 2016 we subleased our rights to
the Cambridge, MA manufacturing facility to Brammer
Bio MA, LLC (Brammer). Brammer also purchased
from us certain manufacturing equipment, leasehold
improvements and other assets in exchange for
shares of Brammer common LLC interests and
assumed manufacturing operations effective January
1, 2017. In December 2016 we closed and vacated
our warehouse space in Somerville, MA.