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For the years ended December 31, 2017, 2016 and 2015 we recorded $27.5 million, $26.5 million and $54.5
million, respectively, which were reflected in research and development expense in our consolidated statements of
income related to this collaboration.
In connection with the collaboration and license agreement, we also received a manufacturing license under
which we received an exclusive license to use AGTC’s proprietary technology platform to make AAV vectors for up to
six genes, three of which are in AGTC’s discretion, in exchange for payment of milestones and royalties.
University of Pennsylvania
In May 2016 we entered into a collaboration and alliance with the University of Pennsylvania (UPenn) to
advance gene therapy and gene editing technologies. The collaboration is primarily focused on the development of
therapeutic approaches that target the eye, skeletal muscle and the central nervous system. The alliance is also
focused on the research and validation of next-generation gene transfer technology
using adeno-associated virus
gene delivery vectors and exploring the expanded use of genome editing technology as a potential therapeutic
platform.
Upon entering into this agreement we made an upfront payment of $20.0 million to UPenn, which was recorded
as research and development expense in our consolidated statements of income, and made prepaid research and
development expenditures of $15.0 million, which was recorded in investments and other assets
in our consolidated
balance sheets. During 2017, we made additional prepaid research and development expenditures to UPenn of
$29.1 million related to the advancement of these programs. These prepaid research and development amounts are
being expensed as the services are provided, of which $12.7 million remains as a prepaid asset as of December 31,
2017. We also expect to fund an additional $18.4 million in additional research and development costs in seven
preclinical research
and development programs, as well as the exploration of genome-editing technology.
If all of the collaborations programs are successful and we exercise all of our options under the UPenn
collaboration and alliance, we may be required to make future payments of over $2.0 billion in research funding,
options and milestone payments. UPenn is also eligible to receive royalties in the mid-single digit to mid-teens
percentages of annual net sales upon successful development and commercialization of new product candidates.
For the years ended December 31, 2017 and 2016, we recorded $33.0 million and $27.8 million, respectively,
in research and development expense in our consolidated statements of income related to this collaboration.
Other Research and Discovery Arrangements
For the years ended December 31, 2017, 2016 and 2015, we entered into several research, discovery and
other related arrangements that resulted in $10.0 million, $10.3 million and $9.7 million, respectively, recorded as
research and development expense in our consolidated statements of income.
These arrangements may include the potential for future milestone payments based on the achievement of
certain clinical and commercial development payable over a period of several years.
Samsung Bioepis
Joint Venture Agreement
In February 2012 we entered into a joint venture agreement
with Samsung Biologics, establishing an entity,
Samsung Bioepis, to develop, manufacture and market biosimilar pharmaceuticals. Samsung
Biologics contributed
280.5 billion South Korean won (approximately $250.0 million) for an 85% stake in Samsung Bioepis and we
contributed approximately 49.5 billion South Korean won (approximately $45.0 million) for the remaining 15%
ownership interest. Under the joint venture agreement, we have no obligation to provide any additional funding and
our ownership interest may be diluted due to financings in which we do not participate. As of December 31, 2017,
our ownership interest is approximately 5%, which reflects the effect of additional equity financings in which we did
not participate. We maintain an option to purchase additional stock in Samsung Bioepis that would allow us to
increase our ownership percentage up to 49.9%. The exercise of this option is within our control and is based on
paying for 49.9% of the total investment made by Samsung Biologics into Samsung Bioepis in excess of what we
have already contributed under the joint venture agreement plus a rate that will represent their return on capital. If
we do not exercise this option by mid-2018, this option will expire and Samsung Biologics will have the right to
purchase all of Samsung Bioepis’ shares then held by us.
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We account for this investment under the equity method of accounting as we maintain
the ability to exercise
significant influence over Samsung Bioepis through a presence on the entity’s Board of Directors and our contractual
relationship. Under the equity method, we recorded our original investment at cost and subsequently adjust the
carrying value of our investment for our share of equity in the entity’s income or losses according to our percentage
of ownership. We recognize our share of the results of operations related to our investment in Samsung Bioepis one
quarter in arrears when the results of the entity become available, which is reflected as equity in loss of investee,
net of tax in our consolidated statements of income. During the year ended December 31, 2015, we recognized a
loss on our investment of $12.5 million. During 2015, as our share of losses exceeded the carrying value of our
investment, we suspended recognizing additional losses and will continue to do so unless we commit to providing
additional funding.
Commercial Agreement
In December 2013 pursuant to our rights under the joint venture agreement with Samsung Biologics, we
entered into an agreement with Samsung Bioepis to commercialize, over a 10-year term, three anti-tumor necrosis
factor (TNF) biosimilar product candidates in Europe and in the case of one anti-TNF biosimilar, Japan. Under this
agreement, we have made total upfront and clinical development milestone payments of $46.0 million, all of which
have been recorded as research and development expense in our consolidated statements of income as the
programs they relate to had not achieved regulatory approval. We also agreed to make additional milestone
payments of $25.0 million upon regulatory approval in the E.U. for each of the three anti-TNF biosimilar product
candidates. During the years ended December 31, 2017 and 2016, we paid $25.0 million and $50.0 million,
respectively, in milestone payments, which have been capitalized in intangible assets, net in our consolidated
balance sheets as IMRALDI received regulatory approval in the E.U. in August 2017, BENEPALI received regulatory
approval in the E.U. in January 2016 and FLIXABI received regulatory approval in the E.U. in May 2016.
We began to recognize revenues on sales of BENEPALI in the E.U. in the first quarter of 2016 and FLIXABI in
the E.U. in the third quarter of 2016. We reflect revenues on sales of BENEPALI and FLIXABI to third parties in
product revenues, net in our consolidated statements of income and record the related cost of revenues and sales
and marketing expenses in our consolidated statements of income to their respective line items when these costs
are incurred. We share 50% of the profit or loss related to our commercial agreement with Samsung Bioepis. This
profit sharing with Samsung Bioepis is recognized in collaboration profit (loss) sharing in our consolidated
statements of income. For the years ended December 31, 2017 and 2016, we recognized a net expense of $111.0
million and $15.1 million, respectively, to reflect Samsung Bioepis's 50% sharing of the net collaboration profits.
Other Services
Simultaneous with the formation of Samsung Bioepis, we also entered into a license agreement, a
technical
development services agreement and a manufacturing agreement with Samsung Bioepis. Under the license
agreement, we granted Samsung Bioepis an exclusive license to use, develop, manufacture and commercialize
biosimilar products created by Samsung Bioepis using Biogen product-specific technology. In exchange, we will
receive single digit royalties on all biosimilar products developed and commercialized by Samsung Bioepis. Under the
technical development services agreement, we provide Samsung Bioepis technical development and technology
transfer services, which include, but are not limited to, cell culture development, purification
process development,
formulation development and analytical development. Under our manufacturing agreement, we manufacture clinical
and commercial quantities of bulk drug substance of biosimilar products for Samsung Bioepis pursuant to
contractual terms. Under limited circumstances, we may also supply Samsung Bioepis with quantities of drug
product of biosimilar products for use in clinical trials through arrangements with third-party contract manufacturers.
For the years ended December 31, 2017, 2016 and 2015, we recognized $42.7 million, $20.2 million and
$62.9 million, respectively, in revenues in relation to these services, which is reflected as a component of other
revenues in our consolidated statements of income.
21.
Litigation
We are currently involved in various claims and legal proceedings, including the matters described below. For
information as to our accounting policies relating to claims and legal proceedings, including
use of estimates and
contingencies, please read Note 1, Summary of Significant Accounting Policies, to these consolidated financial
statements.