`
`x
`
`
`o
`
`U NITED STATES SECU R ITIES AND EXCHANGE COMMISSIONU NITED STATES SECU R ITIES AND EXCHANGE COMMISSION
`
`
`Washington, D.C. 20549Washington, D.C. 20549
`
`Form 10-KForm 10-K
`
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`
`For the fiscal year ended December 31, 2016For the fiscal year ended December 31, 2016
`
`oror
`
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`
`
`Commission file number: 0-19311Commission file number: 0-19311
`
`
`
`BIOGEN INC.BIOGEN INC.
`
`(Exact name of registrant as specified in its charter)
`
`DelawareDelaware
`
`33-011264433-0112644
`
`
`(State or other jurisdiction of incorporation or organization)
`(I.R.S. Employer Identification No.)
`
`225 Binney Street, Cambridge, Massachusetts 02142225 Binney Street, Cambridge, Massachusetts 02142
`
`(617) 679-2000(617) 679-2000
`(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
`
`Securities registered pursuant to Section 12(b) of the Act:Securities registered pursuant to Section 12(b) of the Act:
`
`
`Ti tl e of Each Cl assTi tl e of Each Cl ass
`
`Name of Each Exchange on Whi ch Regi steredName of Each Exchange on Whi ch Regi stered
`
`
`
`Common Stock, $0.0005 par valueCommon Stock, $0.0005 par value
`
`The Nasdaq Global Select MarketThe Nasdaq Global Select Market
`
`Securities registered pursuant to Section 12(g) of the Act:Securities registered pursuant to Section 12(g) of the Act:
`
`NoneNone
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No o
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes o No x
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
`1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
`filing requirements for the past 90 days. Yes x No o
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
`required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant
`was required to submit and post such files): Yes x No o
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to
`the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any
`amendment to this Form 10-K. x
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
`See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
`Large accelerated filer x
`Accelerated filer o
`Non-accelerated filer o
` Smaller reporting company o
`
`
`
`
`
`(Do not check if a smaller reporting company)
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x
`The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant (without admitting that any person whose shares
`are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last business day
`of the registrant’s most recently completed second fiscal quarter was $52,843,669,823.
`As of January 27, 2017, the registrant had 215,951,945 shares of common stock, $0.0005 par value, outstanding.
`
`DOCUMENTS INCORPORATED BY REFERENCEDOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive proxy statement for our 2017 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 1
`
`

`

`Table of Contents
`
`
`
`
`
`BIOGEN INC.BIOGEN INC.
`
`
`ANNUAL REPORT ON FORM 10-KANNUAL REPORT ON FORM 10-K
`
`For the Year Ended December 31, 2016For the Year Ended December 31, 2016
`
`TABLE OF CONTENTSTABLE OF CONTENTS
`
`
`
`PART IPART I
`
`
`
`PagePage
`
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`
`Item 5.
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
`
`
`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
`
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`PART IIPART II
`
`Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
`Selected Financial Data
`Management’s Discussion and Analysis of Financial Condition and Results of Operations
`Quantitative and Qualitative Disclosures About Market Risk
`Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Other Information
`
`
`
`PART IIIPART III
`
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accounting Fees and Services
`
`Exhibits and Financial Statement Schedules
`
`Item 15.
`
`Signatures
`Consolidated Financial Statements
`Exhibit Index
`
`
`
`PART IVPART IV
`
`
`
`1
`29
`41
`42
`43
`43
`
`44
`46
`48
`79
`81
`81
`82
`82
`
`83
`83
`83
`83
`83
`
`84
`
`85
`F- 1
`A- 1
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 2
`
`

`

`Table of Contents
`
`NOTE REGARDING FORWARD-LOOKING STATEMENTSNOTE REGARDING FORWARD-LOOKING STATEMENTS
`
`This report contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act of
`1995 (the Act) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the Act. These forward-looking statements may be
`accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,”
`“will” and other words and terms of similar meaning. Reference is made in particular to forward-looking statements regarding:
`• the anticipated amount, timing and accounting of revenues, contingent payments, milestone, royalty and other payments under licensing,
`collaboration or acquisition agreements, tax positions and contingencies, collectability of receivables, pre-approval inventory, cost of sales, research
`and development costs, compensation and other selling, general and administrative expenses, amortization of intangible assets, foreign currency
`exchange risk, estimated fair value of assets and liabilities, and impairment assessments;
`• expectations, plans and prospects relating to sales, pricing, growth and launch of our marketed and pipeline products;
`• the potential impact of increased product competition in the markets in which we compete;
`• the spin off of our hemophilia business, including its anticipated benefits, costs and tax treatment;
`• the anticipated amount and timing of payments under the Settlement and License Agreement with Forward Pharma A/S (Forward Pharma) and the
`timing, outcome and impact of administrative, regulatory, legal and other proceedings related to our patents and other proprietary intellectual property
`rights under our agreement with Forward Pharma;
`• patent terms, patent term extensions, patent office actions and expected availability and period of regulatory exclusivity;
`• the costs and timing of potential clinical trials, filing and approvals, and the potential therapeutic scope of the development and commercialization of
`our and our collaborators’ pipeline products;
`• the drivers for growing our business, including our plans and intent to commit resources relating to business development opportunities and research
`and development programs;
`• potential costs and expenses incurred in connection with corporate restructurings and to execute business transformation and optimization
`initiatives;
`• our manufacturing capacity, use of third-party contract manufacturing organizations and plans and timing relating to the expansion of our
`manufacturing capabilities, including anticipated investments and activities in new manufacturing facilities;
`• the expected financial impact of ceasing manufacturing activities and vacating our biologics manufacturing facility in Cambridge, MA and warehouse
`space in Somerville, MA;
`• the potential impact on our results of operations and liquidity of the United Kingdom's (U.K.'s) intent to voluntarily depart from the European Union
`(E.U.);
`• the impact of the continued uncertainty of the credit and economic conditions in certain countries in Europe and our collection of accounts receivable
`in such countries;
`• the potential impact of healthcare reform in the United States (U.S.) and measures being taken worldwide designed to reduce healthcare costs to
`constrain the overall level of government expenditures, including the impact of pricing actions and reduced reimbursement for our products;
`• the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to patents and other proprietary and intellectual
`property rights, tax audits, assessments and settlements, pricing matters, sales and promotional practices, product liability and other matters;
`• lease commitments, purchase obligations and the timing and satisfaction of other contractual obligations;
`• our ability to finance our operations and business initiatives and obtain funding for such activities; and
`• the impact of new laws and accounting standards.
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 3
`
`

`

`Table of Contents
`
`These forward-looking statements involve risks and uncertainties, including those that are described in the “Risk Factors” section of this report and
`elsewhere in this report, that could cause actual results to differ materially from those reflected in such statements. You should not place undue reliance
`on these statements. Forward-looking statements speak only as of the date of this report. Except as required by law, we do not undertake any obligation to
`publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
`
`NOTE REGARDING COMPANY AND PRODUCT REFERENCESNOTE REGARDING COMPANY AND PRODUCT REFERENCES
`
`References in this report to:
`
`• “Biogen,” the “company,” “we,” “us” and “our” refer to Biogen Inc. and its consolidated subsidiaries;
`
`• “RITUXAN” refers to both RITUXAN (the trade name for rituximab in the U.S., Canada and Japan) and MabThera (the trade name for rituximab outside
`the U.S., Canada and Japan);
`
`• "ELOCTATE" refers to both ELOCTATE (the trade name for Antihemophilic Factor (Recombinant), Fc Fusion Protein in the U.S., Canada and Japan) and
`ELOCTA (the trade name for Antihemophilic Factor (Recombinant), Fc Fusion Protein in the E.U.); and
`
`• “ANGIOMAX” refers to both ANGIOMAX (the trade name for bivalirudin in the U.S., Canada and Latin America) and ANGIOX (the trade name for
`bivalirudin in Europe).
`
`NOTE REGARDING TRADEMARKSNOTE REGARDING TRADEMARKS
`
`AVONEX®, BENEPALI®, FLIXABI®, PLEGRIDY®, RITUXAN®, TECFIDERA®, TYSABRI® and ZINBRYTA® are registered trademarks of Biogen.
`FUMADERMTM and SPINRAZATM are trademarks of Biogen. ALPROLIX®, ELOCTATE®, ENBREL®, FAMPYRATM, GAZYVA®, HUMIRA®, OCREVUS®,
`REMICADE® and other trademarks referenced in this report are the property of their respective owners.
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 4
`
`

`

`Table of Contents
`
`
`
`Item 1. BusinessItem 1. Business
`
`
`
`PART IPART I
`
`OverviewOverview
`
`Biogen is a global biopharmaceutical company focused on discovering, developing, manufacturing and delivering therapies to people living with
`serious neurological, rare and autoimmune diseases.
`
`Our marketed products include TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, ZINBRYTA and FAMPYRA for multiple sclerosis (MS), FUMADERM for the
`treatment of severe plaque psoriasis and SPINRAZA for the treatment of spinal muscular atrophy (SMA). We also have certain business and financial rights
`with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions, GAZYVA indicated for the
`treatment of CLL and follicular lymphoma and other potential anti-CD20 therapies under a collaboration agreement with Genentech, Inc. (Genentech), a
`wholly-owned member of the Roche Group (Roche Group).
`
`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 areas of our scientific, manufacturing and technical capabilities. For nearly two
`decades we have led in the research and development of new therapies to treat MS, resulting in our leading portfolio of MS treatments. Now our research
`is focused on additional improvements in the treatment of MS, such as the development of next generation therapies for MS, with a goal to reverse or
`possibly repair damage caused by the disease. We are also applying our scientific expertise to solve some of the most challenging and complex diseases,
`including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS), and are employing innovative technologies to discover potential
`treatments for rare and genetic disorders, including new ways of treating diseases through gene therapy.
`
`Our innovative drug development and commercialization activities are complemented by our biosimilar therapies that expand access to medicines
`and reduce the cost burden for healthcare systems. We are leveraging our manufacturing capabilities and know-how to develop, manufacture and market
`biosimilars through Samsung Bioepis, our joint venture with Samsung BioLogics Co. Ltd. (Samsung Biologics). Under this agreement, we are currently
`manufacturing and commercializing two anti-tumor necrosis factor (TNF) biosimilars in certain European Union (E.U.) countries.
`
`1
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 5
`
`

`

`Table of Contents
`
`Key DevelopmentsKey Developments
`
`During 2016 we had a number of key developments affecting our business.
`
`
`
`
`
`Corporate MattersCorporate Matters
`
`Hemophilia Spin-Off
`In May 2016 we announced our intention to spin off our hemophilia
`business, Bioverativ Inc. (Bioverativ), as an independent, publicly traded
`company. Bioverativ will focus on the discovery, development and
`commercialization of therapies for treatment of hemophilia and other
`blood disorders, including ELOCTATE for the treatment of hemophilia A and
`ALPROLIX for the treatment of hemophilia B. Bioverativ will also assume
`all of our rights and obligations under our collaboration agreement with
`Swedish Orphan Biovitrum AB (Sobi) and our collaboration and license
`agreement with Sangamo Biosciences Inc. (Sangamo).
`
`On February 1, 2017, we completed the distribution of all the then
`outstanding shares of common stock of Bioverativ to Biogen stockholders,
`who received one share of Bioverativ common stock for every two shares
`of Biogen common stock. As a result of the distribution, Bioverativ is now
`an independent public company whose shares of common stock are
`trading under the symbol "BIVV" on the Nasdaq Global Select Market.
`
`The financial results of Bioverativ are included in our consolidated
`results of operations and financial position in our audited consolidated
`financial statements for the periods presented in this Form 10-K. The
`financial results of Bioverativ will be excluded from our consolidated
`results of operations and financial position commencing February 1,
`2017. For additional information regarding the separation of Bioverativ,
`please read Note 26, Subsequent Events to our consolidated financial
`statements included in this report.
`
`Management Changes
`During 2016 we appointed several new executives, each of whom
`has significant experience in the biopharmaceutical industry and is a
`leader in his or her functional area. These include Michel Vounatsos, Chief
`Executive Officer, Michael D. Ehlers, Executive Vice President, Research
`and Development and Paul McKenzie, Executive Vice President,
`Pharmaceutical Operations and Technology. For additional information
`related to these and our other Executive Officers, please read "Our
`Executive Officers" included in this report.
`
`Cost Saving Initiatives
`In 2016 we initiated cost saving measures intended to realign our
`organizational structure in anticipation of the changes in roles and
`workforce resulting from our decision to spin off our hemophilia business,
`as well as to achieve further targeted cost reductions.
`
`In December 2016 after an evaluation of our manufacturing capacity
`and needs, we ceased manufacturing at our Cambridge, MA
`manufacturing facility and subleased our rights to this facility to Brammer
`Bio MA, LLC (Brammer). In addition to the sublease, Brammer purchased
`certain leasehold improvements and other assets at this facility and
`agreed to provide certain manufacturing and other transition and support
`services to us.
`
`TECFIDERA Settlement and License Agreement
`In January 2017 we agreed to enter into a settlement and license
`agreement with Forward Pharma A/S (Forward Pharma). The settlement
`and license agreement provides us an irrevocable license to all
`intellectual property owned by Forward Pharma and results in the
`termination of the German Infringement Litigation. Under the terms of the
`settlement and license agreement with Forward Pharma, we agreed to pay
`Forward Pharma $1.25 billion in cash. During the fourth quarter of 2016
`we recognized a pre-tax charge of $454.8 million related to this matter.
`For more information on the settlement and license agreement please
`read Note 21, Commitments and Contingencies to our consolidated
`financial statements included in this report.
`
`2
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 6
`
`

`

`Table of Contents
`
`
`
`Product/Pipeline DevelopmentsProduct/Pipeline Developments
`
`
`
`Multiple SclerosisMultiple Sclerosis
`
`TYSABRI (natalizumab)
`l In June 2016 the European Commission (EC) approved a variation to the marketing authorization of TYSABRI, which extended its indication to
`include relapsing-remitting MS patients with highly active disease activity despite a full and adequate course of treatment with at least one disease
`modifying therapy. TYSABRI was previously indicated only for patients who had failed to respond to beta-interferon or glatiramer acetate in the E.U.
`
`
`ZINBRYTA (daclizumab)
`l ZINBRYTA was approved for the treatment of relapsing forms of MS in the U.S. in May 2016 and the E.U. in July 2016.
`
`
`Opicinumab (Anti-LINGO-1)
`l In June 2016 we reported top-line results from SYNERGY, our Phase 2 trial evaluating opicinumab in people with relapsing forms of MS.
`Opicinumab did not meet the primary endpoint or its secondary efficacy endpoint. However, based on these results, there was a subset of patients
`within the study that we believe have potential to benefit from treatment, and we are therefore planning another Phase 2 clinical trial related to
`opicinumab.
`
`
`
`NeurodegenerationNeurodegeneration
`
`
`
`
`
`Aducanumab (BIIB037)
`l In June 2016 we announced that aducanumab, our investigational treatment for early Alzheimer’s disease, was accepted into the European
`Medicines Agency's (EMA's) Priority Medicines (PRIME) program. PRIME aims to bring treatments to patients more quickly by enhancing the EMA's
`support for the development of investigational medicines for diseases without available treatments or in need of better treatment options.
` l In September 2016 aducanumab was granted "Fast Track" designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track
`program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.
` l In September 2016 we announced that efficacy and safety data from an additional interim analysis from our Phase 1b study of aducanumab in
`early Alzheimer's disease were consistent with results previously reported from the Phase 1b study.
` l In December 2016 we presented new data from the Phase 1b study of aducanumab, which included interim results from the titration cohort of the
`placebo-controlled period of the Phase 1b study as well as data from the first year of the long-term extension. The results supported the ongoing
`Phase 3 studies of aducanumab for early Alzheimer’s disease.
`
`
`
`
`
`Rare DiseasesRare Diseases
`
`
`
`
`
`
`
`SPINRAZA (nusinersen)
`l In August 2016 we and Ionis Pharmaceuticals, Inc. (Ionis) announced that SPINRAZA met the primary endpoint for the interim analysis of ENDEAR,
`the Phase 3 trial evaluating SPINRAZA in infantile-onset (consistent with Type 1) SMA. Based on these results, we exercised our option under our
`collaboration agreement with Ionis to assume development and commercialization of SPINRAZA, and paid Ionis a $75.0 million license fee in
`connection with our option exercise.
` l In September 2016 we completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of SPINRAZA, and in October
`2016 we filed a marketing authorization application (MAA) with the EMA, which had already granted Accelerated Assessment status to SPINRAZA.
`These applications have been accepted for review by the applicable regulatory authorities.
` l In October 2016 we dosed our first patient in our infantile-onset SMA Expanded Access Program to provide patient access to SPINRAZA.
` l In November 2016 we and Ionis announced that SPINRAZA met the primary endpoint for the interim analysis of CHERISH, the Phase 3 trial
`evaluating SPINRAZA in later-onset (consistent with Type 2) SMA. The analysis found that children receiving SPINRAZA experienced a highly
`statistically significant improvement in motor function compared to those who did not receive treatment. SPINRAZA demonstrated a favorable
`safety profile in the study.
` l In December 2016 SPINRAZA was approved by the FDA for the treatment of SMA in pediatric and adult patients in the U.S. The FDA also issued us
`a rare pediatric disease priority review voucher with the approval of SPINRAZA, which confers priority review to a subsequent drug application that
`would not otherwise qualify for priority review.
`
`
`
`3
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 7
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`

`

`Table of Contents
`
`
`
`Biosimilars (Samsung Bioepis - Biogen's Joint Venture with Samsung Biologics)Biosimilars (Samsung Bioepis - Biogen's Joint Venture with Samsung Biologics)
`
`BENEPALI
`l In January 2016 the EC approved Samsung Bioepis' MAA for BENEPALI, an etanercept biosimilar referencing ENBREL, for marketing in the E.U.
`Under our agreement with Samsung Bioepis, we are manufacturing and commercializing BENEPALI in specified E.U. countries.
`
`
`
`FLIXABI
`l In May 2016 the EC approved Samsung Bioepis' MAA for FLIXABI, an infliximab biosimilar candidate referencing REMICADE, for marketing in the
`E.U. Under our agreement with Samsung Bioepis, we are manufacturing and commercializing FLIXABI in specified E.U. countries.
`
`
`Adalimumab (SB5)
`l In July 2016 the EMA accepted Samsung Bioepis' MAA for SB5, an adalimumab biosimilar candidate referencing HUMIRA.
`
`
`
`Genentech RelationshipsGenentech Relationships
`
`
`
`
`
`GAZYVA (obinutuzumab)
`l In February 2016 the Roche Group announced that the FDA approved GAZYVA plus bendamustine chemotherapy followed by GAZYVA alone as a
`new treatment for people with follicular lymphoma who did not respond to a RITUXAN-containing regiment, or whose follicular lymphoma returned
`after such treatment.
` l In May 2016 the Roche Group announced positive results from the Phase 3 GALLIUM study, which investigated the efficacy and safety of GAZYVA
`in combination with chemotherapy followed by maintenance with GAZYVA alone, compared to RITUXAN in combination with chemotherapy
`followed by maintenance with RITUXAN alone in previously untreated patients with follicular lymphoma. Results from pre-planned interim analysis
`showed that GAZYVA-based treatment significantly reduced the risk of disease worsening or death compared to RITUXAN-based treatment.
` l In July 2016 the Roche Group announced that the Phase 3 GOYA study evaluating GAZYVA plus CHOP chemotherapy in people with previously
`untreated diffuse large B-cell lymphoma did not meet its primary endpoint of significantly reducing the risk of disease worsening or death
`compared to RITUXAN plus CHOP chemotherapy. Adverse events with GAZYVA and RITUXAN were consistent with those seen in previous clinical
`trials when each was combined with various chemotherapies.
`
`
`OCREVUS (ocrelizumab)
`l In June 2016 the Roche Group announced that the EMA validated its MAA of OCREVUS for the treatment of relapsing multiple sclerosis (RMS) and
`primary progressive multiple sclerosis (PPMS) in the E.U. The FDA has also accepted for review the Roche Group's Biologics License Application
`(BLA) for OCREVUS for the treatment of RMS and PPMS.
`
`
`RITUXAN (rituximab)
`l In November 2016 Genentech announced the FDA accepted its BLA for a subcutaneous formulation of RITUXAN.
`
`Discontinued ProgramsDiscontinued Programs
`
`l During 2016 we discontinued development of amiselimod (MT-1303) under our agreement with Mitsubishi Tanabe Pharma Corporation, and
`IONIS-DMPKRx under one of our collaboration agreements with Ionis. Additionally, we terminated our collaboration agreements with Rodin
`Therapeutics, Inc. and Ataxion Inc.
`
`4
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 8
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`

`

`Table of Contents
`
`Marketed ProductsMarketed Products
`
`The following graphs show our revenues by product and revenues from anti-CD20 therapeutic programs and geography as a percentage of revenue for
`the years ended December 31, 2016, 2015 and 2014.
`
`
`
`(1) Interferon includes AVONEX and PLEGRIDY
`(2) Other includes ZINBRYTA, FAMPYRA, ELOCTATE, ALPROLIX, FUMADERM, SPINRAZA,
`BENEPALI and FLIXABI
`
`Product sales for TECFIDERA, AVONEX and TYSABRI and anti-CD20 therapeutic programs for RITUXAN each accounted for more than 10% of our total
`revenue for the years ended December 31, 2016, 2015 and 2014. For additional financial information about our product and other revenues and
`geographic areas in which we operate, please read Note 24, Segment Information to our consolidated financial statements, Item 6. Selected Financial
`Data and Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations included in this report. A discussion of the risks
`attendant to our operations is set forth in the “Risk Factors” section of this report.
`
`5
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 9
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`

`

`Table of Contents
`
`Multiple SclerosisMultiple Sclerosis
`
`We develop, manufacture and market a number of products designed to treat patients with MS. MS is a progressive neurological disease in which the
`body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. Patients with active
`relapsing MS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted by flare-ups of the disease after
`which the patient returns to a new baseline of functioning.
`Our MS products and major markets include:
`
`ProductProduct
`
`
`
`Indi cati onIndi cati on
`
`
`
` Col l aborator
`Col l aborator
`
`
`
`
`
`
`
`
`
`
`
`
`Relapsing forms of MS in the U.S.
`
`Relapsing-remitting MS (RRMS) in the E.U.
`
`
`
`Relapsing forms of MS
`
`
`
`Relapsing forms of MS in the U.S.
`
`RRMS in the E.U.
`
`
`
`Relapsing forms of MS
`
`Crohn's disease in the U.S.
`
`
`
`None
`
`
`
`
`None
`
`
`
`
`None
`
`
`
`
`None
`
`
`
`
`Relapsing forms of MS
`
`AbbVie Inc. (AbbVie)
`
`
`
`
`
`
`Walking ability for patients with MS
`
`Acorda Therapeutics, Inc. (Acorda)
`
`
`
` Maj or Mark ets
`Maj or Mark ets
`
`U.S.
`France
`Germany
`Italy
`Spain
`
`United Kingdom
`
`U.S.
`France
`Germany
`Italy
`Spain
`
`United Kingdom
`
`U.S.
`France
`Germany
`Italy
`Spain
`
`United Kingdom
`
`U.S.
`France
`Germany
`Italy
`Spain
`
`United Kingdom
`
`U.S.
`Germany
`
`
`
`France
`Germany
`Spain
`
`
`
`Spinal Muscular AtrophySpinal Muscular Atrophy
`
`SMA is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy and
`weakness. Ultimately, individuals with the most severe type of SMA can become paralyzed and have difficulty performing the basic functions of life, like
`breathing and swallowing. Due to a loss of, or defect in the SMN1 gene, people with SMA do not produce enough survival motor neuron (SMN) protein,
`which is critical for the maintenance of motor neurons. The severity of SMA correlates with the amount of SMN protein. People with Type 1 SMA, the most
`severe life-threatening form, produce very little SMN protein and do not achieve the ability to sit without support or live beyond two years without respiratory
`support. People with Type 2 and Type 3 produce greater amounts of SMN protein and have less severe, but still life-altering, forms of SMA.
`
`In December 2016 the FDA approved SPINRAZA for the treatment of SMA in pediatric and adult patients. We are currently in the early stages of
`commercial launch in the U.S.
`
`6
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 10
`
`

`

`Table of Contents
`
`Our products for SMA and major markets include:
`
`ProductProduct
`
`
`
`
`
`OtherOther
`
`ProductProduct
`
`
`
`Indi cati onIndi cati on
`
`
`
`Spinal muscular atrophy
`
`
`
`Indi cati onIndi cati on
`
`
`Moderate to severe plaque psoriasis
`
` Col l aborator
`Col l aborator
`
`
`Ionis
`
`
`
` Col l aborator
`Col l aborator
`
`
`None
`
`
`
` Maj or Mark ets
`Maj or Mark ets
`
`
`U.S.
`
`
`
` Maj or Mark ets
`Maj or Mark ets
`
`Germany
`
`
`
`BiosimilarsBiosimilars
`
`Biosimilars are a group of biologic medicines that are similar to currently available biologic therapies known as originators. Under our agreement with
`Samsung Bioepis, we manufacture and commercialize two anti-TNF biosimilars in certain countries in the E.U.: BENEPALI, an etanercept biosimilar
`referencing ENBREL and FLIXABI, an infliximab biosimilar referencing REMICADE:
`
`ProductProduct
`
`
`
`
`
`Indi cati onIndi cati on
`
`
`Moderate to severe rheumatoid arthritis
`Progressive psoriatic arthritis
`Axial spondyloarthritis
`Moderate to severe plaque psoriasis
`
`
`Rheumatoid arthritis
`Moderate to severe Crohn's disease
`Severe ulcerative colitis
`Severe ankylosing spondylitis
`Psoriatic arthritis
`Moderate to severe plaque psoriasis
`
` Maj or Mark ets
`Maj or Mark ets
`
`Denmark
`Germany
`Netherlands
`Norway
`
`United Kingdom
`
`
`Germany
`Netherlands
`United Kingdom
`
`
`
`Genentech RelationshipsGenentech Relationships
`
`We have a collaboration agreement with Genentech that entitles us to certain business and financial rights with respect to RITUXAN, GAZYVA and
`other anti-CD20 product candidates. Current products include:
`
`ProductProduct
`
`
`
`
`
`Indi cati onIndi cati on
`
`
`Non-Hodgkin's lymphoma
`CLL
`Rheumatoid arthritis
`Two forms of ANCA-associated vasculitis
`
`
`In combination with chlorambucil for previously untreated CLL
`Follicular lymphoma
`
` Maj or Mark ets
`Maj or Mark ets
`
`
`U.S.
`Canada
`
`
`
`
`U.S.
`
`
`
`For information about our anti-CD20 therapeutic programs and related agreements with Genentech, please read Note 1, Summary of Significant
`Accounting Policies and Note 19, Collaborative and Other Relationships to our consolidated financial statements included in this report.
`
`7
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 11
`
`

`

`Table of Contents
`
`
`
`Patient Support and AccessPatient Support and Access
`
`We interact with patients, advocacy organizations and healthcare
`societies in order to gain insights into unmet needs. The insights gained
`from these engagements help us support patients with services, programs
`and applications that are designed to help patients lead better lives.
`Among other things, we provide customer service and other related
`programs for our products, such as disease and product specific websites,
`insurance research services, financial assistance programs, and the
`facilitation of the procurement of our marketed products.
`
`We are dedicated to helping patients obtain access to our therapies.
`Our patient representatives have access to a comprehensive suite of
`financial assistance tools. With those tools, we help patients understand
`their insurance coverage and, if needed, help patients compare and select
`new insurance options and p