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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.
Tax Reform
The 2017 Tax Act has resulted in significant
changes to the U.S. corporate income tax system.
These changes include a federal statutory rate
reduction from 35% to 21%, the elimination or
reduction of certain domestic deductions and credits
and limitations on the deductibility of interest expense
and executive compensation. The 2017 Tax Act also
transitions international taxation from a worldwide
system to a modified territorial system and includes
base erosion prevention measures on non-U.S.
earnings, which has the effect of subjecting certain
earnings of our foreign subsidiaries to U.S. taxation
as GILTI. These changes
are effective beginning in
2018.
The 2017 Tax Act also includes the Transition
Toll Tax, which is a one-time mandatory deemed
repatriation tax on accumulated foreign subsidiaries'
previously untaxed foreign earnings.
Changes in tax rates and tax laws are accounted
for in the period of enactment. Therefore, during the
year ended December 31, 2017, we recorded a
charge totaling $1,173.6 million related to our current
estimate of the provisions of the 2017 Tax Act,
including a $989.6 million expense under the
Transition Toll Tax. The Transition Toll Tax will be paid
over an eight-year period, starting in 2018, and will
not accrue interest.
The 2017 Tax Act will provide us with flexibility in
deploying our cash resources to advance our
business interests. We expect that it will have a
modest positive effect on our income tax rate in 2018
and a potential incremental benefit thereafter.
Hemophilia Spin-Off
On February 1, 2017, we
completed the spin-off
of our hemophilia business, Bioverativ, as an
independent, publicly traded company trading under
the symbol "BIVV" on the Nasdaq Global Select
Market. The spin-off was accomplished through the
distribution of all the then outstanding shares of
common stock of Bioverativ to Biogen shareholders,
who received one share of Bioverativ common stock
for every two shares of Biogen common stock they
owned. The separation and distribution was
structured to be tax-free for shareholders for federal
income tax purposes. Bioverativ assumed all of our
rights and obligations under our collaboration
agreement with Sobi and our collaboration and
license agreement with Sangamo.
Our consolidated
results of operations and
financial position included in this report reflect the
financial results of our hemophilia business for all
periods through January 31, 2017.
For additional information on the spin-off of our
hemophilia business, please read Note 3, Hemophilia
Spin-Off, to our consolidated financial statements
included in this report.
Financial Highlights
Diluted earnings per share attributable to Biogen
Inc. were $11.92 for 2017, representing a decrease
of 29.6% versus the same period in 2016.
As described below under “Results of
Operations,” our income from operations for the year
ended December 31, 2017 reflects the following:
• Total revenues were $12,273.9 million for 2017,
representing an increase of 7.2% over the same
period in 2016.
• Product revenues, net totaled $10,354.7 million
for 2017, representing an increase of 5.5% over
the same period in 2016. This increase was
primarily driven
by revenues from SPINRAZA,
TECFIDERA and BENEPALI, partially offset by the
elimination of worldwide ALPROLIX and
ELOCTATE revenues resulting from the spin-off of
our hemophilia business on February 1, 2017
and a net decrease in total Interferon sales.
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• Revenues from anti-CD20 therapeutic programs
totaled $1,559.2 million for 2017, representing
an increase of 18.6% over the same period in
2016. This increase was primarily driven by
royalty revenues on sales of OCREVUS and
Biogen's share of pre-tax profits on RITUXAN.
• Other revenues totaled $360.0 million for 2017,
representing an increase of 13.8% from the
same period in 2016. This increase was
primarily driven by an increase in other royalty
and corporate revenues.
• Total cost and expenses totaled $6,929.7
million for 2017, representing an increase of
10.0%, compared to the same period in 2016.
This increase was primarily driven by $444.2
million of amortization and impairment charges
related to our U.S. and
rest of world licenses to
Forward Pharma's intellectual property, including
Forward Pharma's intellectual property related to
TECFIDERA, a 14.2% increase in research and
development primarily related to higher
milestone and upfront expenses, a 10.2%
increase in cost of goods sold, a $120.0 million
pre-tax charge to acquired in-process research
and development for an upfront payment made
to Remedy upon the closing of the asset
purchase transaction for BIIB093 and an
increase in collaboration profit sharing. These
increases were partially offset by a $454.8
million litigation settlement charge in the prior
year.
As described below under "Financial Condition,
Liquidity and Capital Resources":
• We generated $4,551.0
million of net cash flows
from operations for 2017, which were primarily
driven by earnings.
• Cash, cash equivalents and marketable
securities totaled approximately $6,746.3
million as of December 31, 2017.
• We repurchased approximately 4.9 million
shares of common stock at a cost of $1.4 billion
during 2017 under our share repurchase
programs.
Acquisitions
BIIB093 Acquisition
In May 2017 we completed an asset purchase of
the Phase 3-ready candidate BIIB093 (intravenous
glibencamide) (formerly known as CIRARA) from
Remedy. The target indication for BIIB093 is LHI, a
severe form of ischemic stroke where cerebral edema
often leads to a disproportionately large share of
stroke-related morbidity and mortality. The FDA
recently granted BIIB093 Orphan Drug Designation for
severe cerebral edema in patients with acute
ischemic stroke. The FDA has also granted BIIB093
Fast Track designation.
Under this agreement, we are responsible for the
future development
and commercialization of
BIIB093. Remedy will share in the cost of
development for the target indication for BIIB093 in
LHI stroke.
For additional information on our transaction with
Remedy, please read Note 2, Acquisitions, to our
consolidated financial statements included in this
report.
Collaborative and Other Relationships
BIIB092 License Agreement
In June 2017 we completed an exclusive license
agreement with BMS for BIIB092 (formerly known as
BMS-986168), a Phase 2-ready experimental
medicine with potential in AD and PSP. BIIB092 is an
antibody targeting tau, the protein that forms the
deposits, or tangles, in the brain associated with AD
and other neurodegenerative tauopathies such as PSP.
Under this agreement, we received worldwide
rights to BIIB092 and
are responsible for the full
development and global commercialization of BIIB092
in AD and PSP.
For additional information on our collaboration
arrangement with BMS, please read Note 20,
Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.
Eisai Collaboration Agreement
In October 2017 we entered into a new
collaboration agreement with Eisai for the joint
development and commercialization of aducanumab
(the Aducanumab Collaboration Agreement). Under
the Aducanumab Collaboration Agreement, we will
continue to lead the ongoing Phase 3 development of
aducanumab and will remain responsible for 100% of
development costs for aducanumab until April 2018.
Eisai will then reimburse us for 15% of aducanumab
development expenses for the period April 2018
through December 2018, and 45% thereafter. Upon
commercialization, both companies will co-promote
aducanumab with a region-based profit split.
In addition, we and Eisai
will continue to jointly
develop BAN2401 and E2609.
We and Eisai will co-promote AVONEX, TYSABRI
and TECFIDERA in Japan in certain settings and Eisai
will distribute AVONEX, TYSABRI, TECFIDERA and
PLEGRIDY in India and other Asia-Pacific markets,
excluding China.