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65
Cost and Expenses
A summary of total cost and expenses is as follows:
For the Years Ended
December 31,
% Change
2017
compared to
2016
2016
compared to
2015
(In millions, except percentages)
2017
2016
2015
Cost of sales, excluding amortization of
acquired intangible assets
$
1,630.0
$
1,478.7 $
1,240.4
10.2 %
19.2 %
Research and development
2,253.6
1,973.3
2,012.8
14.2 %
(2.0)%
Selling, general and administrative
1,935.5
1,947.9
2,113.1
(0.6)%
(7.8)%
Amortization of acquired intangible
assets
814.7
385.6
382.6
111.3 %
0.8 %
Acquired in-process research and
development
120.0
—
—
**
**
Collaboration profit sharing
112.3
10.2
—
**
**
Loss (gain) on fair value remeasurement
of contingent consideration
62.7
14.8
30.5
323.6 %
(51.5)%
Restructuring charges
0.9
33.1
93.4
(97.3)%
(64.6)%
TECFIDERA litigation settlement charge
—
454.8
—
(100.0)%
**
Total cost and expenses
$
6,929.7
$
6,298.4 $
5,872.8
10.0 %
7.2 %
** Percentage not meaningful.
Cost of Sales, Excluding Amortization of Acquired
Intangible Assets (Cost of Sales)
Product Cost of Sales
For 2017 compared to 2016, the increase in
product cost of sales was primarily driven by higher
unit sales volume related to our biosimilar product
shipments, higher contract manufacturing shipments
of drug substance production provided to our strategic
partners, including Bioverativ, and an increase in
inventory amounts written down as a result of excess,
obsolescence, unmarketability or other reasons.
These increases were partially offset by the impact
from the spin-off of our hemophilia business on
February 1, 2017, and the accelerated depreciation
recorded in the second, third and fourth quarters of
2016 as a result of our decision to cease
manufacturing in Cambridge, MA.
For 2016 compared to 2015, the increase in
product cost of sales was primarily driven by costs
noted below as well as increased contract
manufacturing shipments and higher unit sales
volume related to our biosimilars and hemophilia
products, partially offset by favorable production costs
and mix of products.
Product cost of sales for 2016 reflects the
recognition of $45.5 million of accelerated
depreciation as a result of the determination to cease
manufacturing in Cambridge, MA and vacate our
small-scale biologics manufacturing facility in
Cambridge, MA and warehouse space in Somerville,
MA.
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Inventory amounts written down as a result of
excess, obsolescence, unmarketability or other
reasons totaled $76.9 million, $48.2 million and
$41.9 million for the years ended December 31,
2017, 2016 and 2015, respectively. Amounts written
down during the year ended December 31, 2017,
includes the impairment of $14.4 million related to
the EC approved restrictions on the use 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.
Royalty Cost of Sales
For 2017 compared to 2016, the increase in
royalty cost of sales was primarily driven by the
recognition of royalties payable to Ionis on sales of
SPINRAZA and higher royalties on sales of AVONEX
and PLEGRIDY in the U.S., as described below. These
increases were partially offset by the elimination of
royalties payable on sales of hemophilia product
resulting from the spin-off of our hemophilia business
on February 1, 2017 and lower royalties on sales of
TYSABRI resulting from the expiration of certain third-
party royalties.
For 2016 compared to 2015, the increase in
royalty cost of sales was primarily driven by the
increase in royalty rates payable to Sobi, increased
sales of our hemophilia products and higher royalties
on sales of AVONEX and PLEGRIDY in the U.S.,
partially offset by a decrease in TYSABRI royalties due
to the expiration of certain third-party royalties.
On June 28, 2016, the U.S. Patent and
Trademark Office issued to the Japanese Foundation
for Cancer Research (JFCR) a patent related to
recombinant interferon-beta protein. This patent, U.S.
Patent No. 9,376,478, expires in June 2033. This
patent was issued following an interference
proceeding between JFCR and us. This patent is
relevant to AVONEX and PLEGRIDY, and we will pay
royalties in the mid-single digits in relation to this
patent during the life of the patent.
Research and Development
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We support our drug discovery and development
efforts through the commitment of significant
resources to discovery, research and development
programs and business development opportunities,
particularly within our core and emerging growth
areas.
A significant amount of our research and
development costs consist of indirect costs incurred
in support of overall research and development
activities and non-specific programs, including
activities that benefit multiple programs, such as
management costs, as well as depreciation,
information technology and facility-based expenses.
These costs are considered other research and
development costs in the table above and are not
allocated to a specific program or stage.
Research and development expense incurred in
support of our marketed products includes costs
associated with product lifecycle management
activities including, if applicable, costs associated
with the development of new indications for existing
products. Late stage programs are programs in Phase
3 development or in registration stage. Early stage
programs are programs in Phase 1 or Phase 2
development. Research and discovery represents
costs incurred to support our discovery research and
translational science efforts. Costs are reflected in
the development stage based upon the program
status when incurred. Therefore, the same program
could be reflected in different development stages in
the same year. For several of our programs, the
research and development activities are part of our
collaborative and other relationships. Our costs reflect
our share of the total costs incurred.
For 2017 compared to 2016, the increase in
research and development expense was primarily
related to milestone and upfront expenses and costs
incurred in connection with our early stage and late
stage programs, partially offset by decreased costs
incurred in connection with our marketed products.
For 2016 compared to 2015, the decrease in
research and development expense was primarily
related to a decrease in costs incurred in connection
with our early stage programs, marketed products and
other research and development costs. These
decreases were partially offset by increased costs
incurred in connection with our late stage and
research and discovery programs.
We intend to continue committing significant
resources to targeted research and development
opportunities where there is a significant unmet need
and where a drug candidate has the potential to be
highly differentiated.
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