Table
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
F- 59
AbbVie
We have a collaboration agreement with AbbVie for the development and commercialization of ZINBRYTA, which
was approved for the treatment of relapsing forms of MS in the U.S. in May 2016 and in the E.U. in July 2016.
Under this agreement, we and AbbVie conduct ZINBRYTA co-promotion activities in the U.S., E.U. and Canadian
territories (Collaboration Territory) where development and commercialization costs and profits are shared equally.
Outside of the Collaboration Territory, we are solely responsible for development and commercialization of ZINBRYTA
and will pay a tiered royalty to AbbVie as a percentage of net sales in the low to high teens.
We are responsible for manufacturing and research and development activities in both the Collaboration
Territory and outside the Collaboration Territory and record these activities within their respective lines in our
consolidated
statements of income, net of any reimbursement of research and development expenditures received
from AbbVie. For the years ended December 31, 2017, 2016 and 2015, the collaboration incurred $39.9 million,
$48.6 million and $113.8 million for research and development activities, respectively, for which we recognized
$19.9 million, $24.3 million and $60.8 million, respectively, in our consolidated statements of income.
Prior to regulatory approval, we also recognized $22.0 million of pre-commercialization expenses within our
selling, general and administrative expense, which represented 50% of the collaboration's pre-commercialization
costs for 2016. After ZINBRYTA was approved by the FDA and European Medicines Agency (EMA) in 2016, we began
to recognize our share of the collaboration activities within the U.S., E.U. and Canadian territories as described
below under "Co-promotion Profits and Losses."
Article 20
Procedure of ZINBRYTA
In July 2017 the EMA announced that it had provisionally restricted the use of ZINBRYTA to adult patients with
highly active relapsing disease despite a full and adequate course of treatment with at least one disease modifying
therapy (DMT) or with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs. These
restrictions followed the initiation of an EMA review (referred to as an Article 20 Procedure) of ZINBRYTA following
the report of a case of fatal fulminant liver failure, as well as four cases of serious liver injury.
In October 2017, as part of this Article 20 Procedure of ZINBRYTA, the EMA Pharmacovigilance Risk Assessment
Committee (PRAC) completed its assessment and recommended a further set of restrictions on the use of ZINBRYTA
by MS patients.
In November 2017 the Committee for Medicinal Products for Human Use (CHMP) adopted an opinion, confirming
the PRAC's
recommendations, for further restrictions to minimize the risk of serious liver injury with ZINBRYTA,
including restriction of its use to adult patients with relapsing forms of MS who have had an inadequate response to
at least two DMTs and for whom treatment with any other DMT is contraindicated or otherwise unsuitable. In January
2018 the EC adopted a final and legally-binding decision, which concluded the Article 20 Procedure, confirming the
CHMP opinion.
The recommendation of these restrictions by the CHMP resulted in the impairment of substantially all of our
assets related to ZINBRYTA as we have determined that these amounts may not be recoverable. As a result, we
recorded net impairment charges related to intangible assets, inventory, property, plant
and equipment and prepaid
tax assets, totaling approximately $190.8 million. Inventory related losses are subject to our profit share with
AbbVie and are included above net of expected reimbursement. Offsetting these amounts was an unrecorded tax
benefit related to certain ZINBRYTA related assets totaling approximately $93.8 million.
Co-promotion Profits and Losses
In the U.S., AbbVie recognizes revenues on sales to third parties and we recognize our 50% share of the co-
promotion profits or losses as a component of total revenues in our consolidated statements of income. The
collaboration began selling ZINBRYTA in the U.S. in the third quarter of 2016. For the years ended December 31,
2017 and 2016, we recognized a net reduction in revenue of $16.9 million and $21.9 million, respectively, to reflect
our share of an overall net loss within the collaboration.
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BIOGEN INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
F- 60
The following table provides a summary of the U.S. collaboration and our share of the co-promotion losses on
ZINBRYTA in the U.S.:
For the Year Ended December 31,
(In millions)
2017
2016
Product
revenues, net
$
53.1 $
6.1
Costs and expenses
92.6
50.0
Co-promotion losses in the U.S.
$
39.5 $
43.9
Biogen's share of co-promotion losses in the U.S.
$
16.9 $
21.9
In the E.U. and Canada, we recognize revenues on sales to third parties in product revenues, net in our
consolidated statements of income. We also record the related cost of revenues and sales and marketing expenses
to their respective line items in our consolidated statements of income as these costs are incurred. We reimburse
AbbVie for their 50% share of the co-promotion profits or losses in the E.U. and Canada. This reimbursement is
recognized in collaboration profit (loss) sharing in our consolidated statements of income. We began to recognize
product revenues on sales of ZINBRYTA in the E.U. in the third quarter of 2016. For the year ended December 31,
2017, we recognized net expense of $1.3 million to reflect AbbVie's 50% sharing of the
net collaboration profits in
the E.U. and Canada, as compared to net income recognized of $4.9 million to reflect AbbVie's 50% sharing of the
net collaboration losses in the E.U. and Canada in the prior year.
Acorda
In June 2009 we entered into a collaboration and license agreement with Acorda Therapeutics, Inc. (Acorda) to
develop and commercialize products containing fampridine, such as FAMPYRA, in markets outside the U.S. We are
responsible for all regulatory activities and the future clinical development of related products in those markets.
Under this agreement, we pay tiered royalties based on the level of ex-U.S. net sales and potential milestone
payments based on the successful achievement of certain regulatory
and commercial milestones, which would be
capitalized as intangible assets upon achievement of the milestones and amortized utilizing an economic
consumption model. The next expected milestone would be $15.0 million, due if ex-U.S. net sales reach $100.0
million over a period of four consecutive quarters. Royalty payments are recognized in cost of sales within our
consolidated statements of income.
In connection with the collaboration and license agreement, we also entered into a supply agreement with
Acorda for the commercial supply of FAMPYRA. This agreement is a sublicense arrangement of an existing
agreement between Acorda and Alkermes, who acquired Elan Drug Technologies, the original
party to the license with
Acorda.
For the years ending December 31, 2017, 2016 and 2015, total cost of sales related to royalties and
commercial supply of FAMPYRA reflected in our consolidated statements of income were $34.0 million, $31.5
million and $30.6 million, respectively.
Ionis Pharmaceuticals, Inc.
Product Collaborations
SPINRAZA
In January 2012 we entered into an exclusive worldwide option and collaboration agreement with Ionis to
develop and commercialize SPINRAZA for the treatment of SMA. During 2014 we amended this agreement to adjust
the amount of potential additional payments and terms of the exercise of our opt-in right to license SPINRAZA, which
included providing for additional opt-in scenarios, based on the filing or acceptance of a New Drug Application (NDA)
with the FDA or marketing authorization application with the EMA. Consistent with the initial agreement, Ionis
remained responsible for conducting the pivotal/Phase 3 trials and we provided input on the
clinical trial design and
regulatory strategy for the development of SPINRAZA.
SPINRAZA was approved for the treatment of SMA in the U.S., E.U. and Japan in December 2016, June 2017
and July 2017, respectively.