United states securities and exchange commission



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Table of Contents
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.


Table of Contents
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.


Table of Contents
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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