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60
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.
Spinal Muscular Atrophy (SMA)
SPINRAZA
We began to recognize revenues on sales of
SPINRAZA in the U.S. in the fourth quarter of 2016
and the rest of world in the first quarter of 2017.
We expect that the rate at which SPINRAZA
revenues will grow will moderate over time due to the
loading dynamics as patients transition to dosing
once every four months.
For additional information on our relationship
with Ionis, please read Note 20, Collaborative and
Other Relationships, to our consolidated financial
statements included in this report.
Biosimilars
BENEPALI and FLIXABI
Under our commercial agreement with Samsung
Bioepis, we began to recognize revenues on sales of
BENEPALI and FLIXABI to third parties in the E.U. in
the first and third quarters of 2016, respectively.
For 2017 compared to 2016, the increase in
biosimilar revenues was primarily due to an increase
in BENEPALI unit sales volume in new and existing
markets.
For additional information on our relationship
with Samsung Bioepis, please read Note 20,
Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.
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61
Revenues from Anti-CD20 Therapeutic
Programs
Genentech (Roche Group)
Our share of RITUXAN and GAZYVA collaboration
operating profits in the U.S. and other revenues on
anti-CD20 therapeutic programs are summarized as
follows:
Biogen’s Share of Pre-tax Profits in the U.S. for
RITUXAN and GAZYVA
The following table provides a summary of
amounts comprising our share of pre-tax profits on
RITUXAN and GAZYVA in the U.S.:
For the Years Ended
December 31,
(In millions)
2017
2016
2015
Product
revenues, net
$4,206.9
$3,941.8 $3,847.9
Cost and
expenses
755.2
744.5
673.7
Pre-tax profits in
the U.S.
$3,451.7
$3,197.3 $3,174.2
Biogen's share of
pre-tax profits
$1,316.4
$1,249.5 $1,269.8
Our share of RITUXAN annual pre-tax co-
promotion profits in the U.S. in excess of $50.0
million decreased to 39% from 40% in February 2016
when GAZYVA was approved by the FDA as a new
treatment for follicular lymphoma and further
decreased to 37.5% in the third quarter of 2017 as
gross sales of GAZYVA in the U.S. for the preceding
12-month period exceeded $150.0 million.
In November 2017 the FDA approved GAZYVA in
combination with chemotherapy, followed by GAZYVA
alone, for people with previously untreated advanced
follicular lymphoma.
In June 2017 the FDA approved RITUXAN
HYCELA for subcutaneous injection for the treatment
of adults with previously untreated and relapsed or
refractory follicular lymphoma, previously untreated
diffuse large B-cell lymphoma and CLL. This new
treatment includes the same monoclonal antibody as
intravenous RITUXAN in combination with
hyaluronidase human, an enzyme that helps to deliver
rituximab under the skin.
For 2017 compared to 2016, the increase in
U.S. product revenues was primarily due to selling
price increases and an increase in RITUXAN and
GAZYA unit sales volume of 2% and 6%, respectively,
partially offset by higher discounts and allowances.
For 2016 compared to 2015, the increase in
U.S. product revenues was primarily due to an
increase in GAZYVA unit sales volume of 41%, an
increase in RITUXAN unit sales of 1% and selling price
increases, partially offset by higher RITUXAN
discounts and allowances.
Collaboration costs and expenses for 2017, as
depicted in the table above, excludes certain
expenses charged to the collaboration by Genentech
that we believe remain the responsibility of Genentech
and that we are not obligated to pay under the terms
of the collaboration agreement. Accordingly, we did
not recognize the effect of those expenses in the
determination of our share of pre-tax collaboration
profits and Genentech has withheld approximately
$120 million from amounts due to us in relation to
collaboration activity for 2017, representing
Genentech’s estimate of our share of these
expenses. We remain in discussions with Genentech
about a resolution relating to these amounts.
Excluding amounts under dispute, collaboration
costs and expenses for 2017 compared to 2016
increased primarily due to higher branded
pharmaceutical drug fees and an increase in RITUXAN
selling and marketing costs, partially offset by a
decrease in GAZYVA research and development costs.
Collaboration costs and expenses for 2016
compared to 2015 increased primarily due to an
increase in RITUXAN product cost of sales.
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62
Other Revenues from Anti-CD20 Therapeutic
Programs
Other revenues from anti-CD20 therapeutic
programs primarily consist of royalty revenues on
sales of OCREVUS and our share of pre-tax co-
promotion profits on RITUXAN in Canada.
For 2017 compared to 2016, other revenues
from anti-CD20 therapeutic programs increased
primarily due to the launch of OCREVUS in the second
quarter of 2017.
For 2016 compared to 2015, other revenues
from anti-CD20 therapeutic programs decreased as a
result of lower pre-tax co-promotion profits on
RITUXAN in Canada.
OCREVUS
In March 2017 the FDA approved OCREVUS, a
humanized anti-CD20 monoclonal antibody, for the
treatment of RMS and PPMS. Under our agreement
with Genentech, we will receive a tiered royalty on
U.S. net sales from 13.5% and increasing up to 24%
if annual net sales exceed $900.0 million. There will
be a 50% reduction to these royalties if a biosimilar to
OCREVUS is approved in the U.S.
In addition, we will receive a 3% royalty on net
sales of OCREVUS outside the U.S., with the royalty
period lasting 11 years from the first commercial sale
of OCREVUS on a country-by-country basis. OCREVUS
was approved for treatment of RMS and PPMS in
Australia, Switzerland and the E.U. in July 2017,
September 2017 and January 2018, respectively.
Marketing applications for OCREVUS are currently
under review in numerous markets worldwide,
including in Latin America and the Middle East.
The commercialization of OCREVUS does not
impact the percentage of the co-promotion profits we
receive for RITUXAN or GAZYVA. Genentech is solely
responsible for development and commercialization of
OCREVUS and funding future costs. OCREVUS royalty
revenues were based on our estimates from third
party and market research data of OCREVUS sales
occurring during the corresponding period. Differences
between actual and estimated royalty revenues will be
adjusted for in the period in which they become
known, which is expected to be the following quarter.
For additional information on our collaboration
with Genentech, including information regarding the
pre-tax profit sharing formula and its impact on future
revenues from anti-CD20 therapeutic programs,
please read Note 20, Collaborative and Other
Relationships, to our consolidated financial
statements included in this report.
Other Revenues
Other revenues are summarized as follows:
For The Years
Ended December 31,
% Change
2017
compared to
2016
2016
compared to
2015
(In millions, except percentages)
2017
2016
2015
Revenues from collaborative and other
relationships
$
36.5
$
39.3 $
69.1
(7.1)%
(43.1)%
Other royalty and corporate revenues
323.5
277.1
167.0
16.7 %
65.9 %
Total other revenues
$
360.0
$
316.4 $
236.1
13.8 %
34.0 %
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