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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.
(d) Income tax expense for the year ended December 31, 2017, includes $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.
For additional information on the 2017 Tax Act, please read Note 17, Income Taxes, to our consolidated
financial statements included in this report.
(e) Total cost and expenses for the years ended December 31, 2017, 2016 and 2015, include restructuring
charges of $0.9 million, $33.1 million and $93.4 million, respectively.
In addition, total cost and expenses for
the year ended December 31, 2016, also include charges to cost of sales totaling $52.4 million of expenses
incurred as a result of our determination to cease manufacturing and vacate our small-scale biologics facility in
Cambridge, MA as well as close and vacate our warehouse in Somerville, MA. Total cost and expenses for the
years ended December 31, 2017 and 2016, also includes $19.2 million and $18.1 million, respectively, of
costs incurred directly related to the spin-off of our hemophilia business into an independent, publicly
traded
company.
(f) Net income attributable to Biogen Inc. for the year ended December 31, 2015, includes a pre-tax charge to
noncontrolling interest of $60.0 million for a milestone payment due to Neurimmune upon the enrollment of the
first patient in a Phase 3 trial for aducanumab.
(g) Commencing in the second quarter of 2013 product and total revenues include 100% of net revenues related
to sales of TYSABRI as a result of our acquisition of all remaining rights to TYSABRI from Elan Pharma
International, Ltd (Elan), an affiliate of Elan Corporation, plc. Upon closing of this transaction, our collaboration
agreement was terminated.
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Item 7.
Management’s Discussion and
Analysis of Financial Condition and Results
of Operations
The following discussion should be read in
conjunction with
our consolidated financial
statements and related notes beginning on page F-1
of this report. Certain totals may not sum due to
rounding.
Executive Summary
Introduction
Biogen is a global biopharmaceutical company
focused on discovering, developing and delivering
worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases,
including in our core growth areas of MS and
neuroimmunology, AD
and dementia, movement
disorders and neuromuscular disorders, including
SMA and ALS. We also plan to invest in emerging
growth areas such as pain, ophthalmology,
neuropsychiatry and acute neurology. In addition, we
are employing innovative technologies to discover
potential treatments for rare and genetic disorders,
including new ways of treating diseases through gene
therapy in the previously mentioned areas. We also
manufacture and commercialize biosimilars of
advanced biologics.
Our marketed products include TECFIDERA,
AVONEX, PLEGRIDY, TYSABRI, ZINBRYTA and FAMPYRA
for the treatment of MS, SPINRAZA for the treatment
of SMA and FUMADERM for the treatment of severe
plaque psoriasis. We also have certain business and
financial rights with respect to RITUXAN for the
treatment of non-Hodgkin's
lymphoma, CLL and other
conditions, GAZYVA for the treatment of CLL and
follicular lymphoma, OCREVUS for the treatment of
PPMS and RMS, and other potential anti-CD20
therapies under a collaboration agreement with
Genentech.
Our current revenues depend upon continued
sales of our principal products and, unless we
develop, acquire rights to and/or commercialize new
products and technologies, we may be substantially
dependent on sales from our principal products for
many years.
In the longer term, our
revenue growth will be
dependent upon the successful clinical development,
regulatory approval and launch of new commercial
products as well as additional indications for our
existing products, our ability to obtain and maintain
patents and other rights related to our marketed
products, assets originating from our research and
development efforts and/or successful execution of
external business development opportunities.
Our innovative drug development and
commercialization activities are complemented by our
biosimilar therapies, which expand access to
medicines and reduce the
cost burden for healthcare
systems. We are leveraging our manufacturing
capabilities and know-how to develop, manufacture
and market biosimilars through Samsung Bioepis, our
joint venture with Samsung Biologics. Under our
commercial agreement, we market and sell BENEPALI,
an etanercept biosimilar referencing ENBREL, and
FLIXABI, an infliximab biosimilar referencing
REMICADE, in the E.U.
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,
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