`
`x
`
`
`o
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`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, 2018For the fiscal year ended December 31, 2018
`
`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 Section 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 every Interactive Data File required to be submitted 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 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,
`or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and "emerging growth
`company" in Rule 12b-2 of the Exchange Act.
`Large accelerated filer x
`Non-accelerated filer o
`
`
`Accelerated filer o
`
`Smaller reporting company o
`
`Emerging growth company o
`
`If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
`new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
`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 $58,267,511,287.
`As of February 1, 2019, the registrant had 196,708,784 shares of common stock, $0.0005 par value, outstanding.
`
`DOCUMENTS INCORPORATED BY REFERENCEDOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive proxy statement for our 2019 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.
`
`
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`

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`Table of Contents
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`
`
`
`
`BIOGEN INC.BIOGEN INC.
`
`
`ANNUAL REPORT ON FORM 10-KANNUAL REPORT ON FORM 10-K
`
`For the Year Ended December 31, 2018For the Year Ended December 31, 2018
`
`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 Accountant Fees and Services
`
`Exhibits and Financial Statement Schedules
`Form 10-K Summary
`
`Item 15.
`Item 16.
`
`Signatures
`Consolidated Financial Statements
`
`
`
`PART IVPART IV
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`
`
`1
`34
`47
`47
`48
`48
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`49
`51
`54
`91
`93
`93
`93
`94
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`95
`95
`95
`95
`95
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`96
`96
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`100
`F- 1
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`Table of Contents
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`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 “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” "goal," “intend,” “may,” “plan,” “potential,”
`“possible,” “will,” “would” 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, 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 timing, outcome and impact of administrative, regulatory, legal and other proceedings related to our patents and other proprietary and intellectual
`property rights, tax audits, assessments and settlements, pricing matters, sales and promotional practices, product liability and other matters;
`• patent terms, patent term extensions, patent office actions and expected availability and period of regulatory exclusivity;
`• the potential impact of increased product competition in the markets in which we compete, including increased competition from generics,
`biosimilars, prodrugs and other products approved under alternative regulatory pathways;
`• our plans and investments in our core and emerging growth areas, as well as implementation of our 2017 corporate strategy;
`• the drivers for growing our business, including our plans and intent to commit resources relating to research and development programs and business
`development opportunities;
`• our ability to finance our operations and business initiatives and obtain funding for such activities;
`• the costs and timing of potential clinical trials, filings and approvals, and the potential therapeutic scope of the development and commercialization
`of our and our collaborators’ pipeline products;
`• adverse safety events involving our marketed products or generic or biosimilar products marketed by others;
`• the potential impact of healthcare reform in the United States (U.S.) and measures being taken worldwide designed to reduce healthcare costs and
`limit the overall level of government expenditures, including the impact of pricing actions and reduced reimbursement for our products;
`• 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 anticipated benefits and the potential costs and expenses related to our current or future initiatives to streamline our operations and reallocate
`resources;
`• 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 on our results of operations and liquidity of the United Kingdom's (U.K.) intent to voluntarily depart from the European Union
`(E.U.);
`• lease commitments, purchase obligations and the timing and satisfaction of other contractual obligations;
`• the impact of new laws, regulatory requirements, judicial decisions and accounting standards; and
`• the anticipated costs and tax treatment of the spin-off of our hemophilia business as well as the timeline for selling substantially all remaining
`hemophilia related inventory.
`
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`Table of Contents
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`These forward-looking statements involve risks and uncertainties, including those that are described in Item 1A. Risk Factors included in 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); and
`
`• "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.).
`
`NOTE REGARDING TRADEMARKSNOTE REGARDING TRADEMARKS
`
`AVONEX®, PLEGRIDY®, RITUXAN®, RITUXAN HYCELA®, SPINRAZA®, TECFIDERA®, TYSABRI® and ZINBRYTA® are registered trademarks of Biogen.
`BENEPALITM, FLIXABITM, FUMADERMTM and IMRALDITM 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.
`
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`Table of Contents
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`
`
`Item 1. BusinessItem 1. Business
`
`
`
`OverviewOverview
`
`
`
`PART IPART I
`
`Biogen is a global biopharmaceutical company focused on discovering, developing and delivering worldwide innovative therapies for people living with
`serious neurological and neurodegenerative diseases, including in our core growth areas of multiple sclerosis (MS) and neuroimmunology, Alzheimer’s
`disease (AD) and dementia, movement disorders, including Parkinson's disease, and neuromuscular disorders, including spinal muscular atrophy (SMA)
`and amyotrophic lateral sclerosis (ALS). We are also focused on discovering, developing and delivering worldwide innovative therapies in our emerging
`growth areas of acute neurology, neurocognitive disorders, pain and ophthalmology. In addition, we are employing innovative technologies to discover
`potential treatments for rare and genetic disorders, including new ways of treating diseases through gene therapy in our core and emerging growth areas.
`We also manufacture and commercialize biosimilars of advanced biologics.
`
`Our marketed products include TECFIDERA, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS, SPINRAZA for the treatment of SMA
`and FUMADERM for the treatment of severe plaque psoriasis. 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, RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and
`CLL, GAZYVA for the treatment of CLL and follicular lymphoma, OCREVUS for the treatment of primary progressive MS (PPMS) and relapsing MS (RMS) and
`other potential anti-CD20 therapies pursuant to our collaboration arrangements with Genentech, Inc. (Genentech), a wholly-owned member of the Roche
`Group. For additional information on our collaboration arrangements with Genentech, please read Note 19, Collaborative and Other Relationships, to our
`consolidated financial statements included in this report.
`
`We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and development
`programs and business development opportunities. For over 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 AD, progressive supranuclear palsy (PSP), Parkinson's disease,
`ALS, stroke, epilepsy, cognitive impairment associated with schizophrenia (CIAS) and pain.
`
`Our innovative drug development and commercialization activities are complemented by our biosimilar products 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
`biosimilar products through Samsung Bioepis Co., Ltd. (Samsung Bioepis), our joint venture with Samsung BioLogics Co., Ltd. (Samsung BioLogics). Under
`our commercial agreement, we market and sell BENEPALI, an etanercept biosimilar referencing ENBREL, FLIXABI, an infliximab biosimilar referencing
`REMICADE, and IMRALDI, an adalimumab biosimilar referencing HUMIRA, in the E.U. For additional information on our collaboration arrangement with
`Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to our consolidated financial statements included in this report.
`
`1
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`Table of Contents
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`Key Business DevelopmentsKey Business Developments
`
`The following is a summary of key developments affecting our business since the beginning of 2018.
`
`For additional information on our acquisitions, collaborative and other relationships discussed below, please read Note 2, Acquisitions, Note 19,
`Collaborative and Other Relationships, Note 20, Investments in Variable Interest Entities, and Note 27, Subsequent Events, to our consolidated financial
`statements included in this report.
`
`Acquisitions, Collaborative and Other RelationshipsAcquisitions, Collaborative and Other Relationships
`
`BIIB100 Acquisition
`In January 2018 we acquired BIIB100 (formerly known as KPT-350) from Karyopharm Therapeutics Inc. (Karyopharm). BIIB100 is a Phase 1 ready
`investigational oral compound for the treatment of certain neurological and neurodegenerative diseases, primarily in ALS. BIIB100 is a novel therapeutic
`candidate that works by inhibiting a protein known as XP01, with the goal of reducing inflammation and neurotoxicity, along with increasing neuroprotective
`responses.
`BIIB104 Acquisition
`In April 2018 we acquired BIIB104 (formerly known as PF-04958242) from Pfizer Inc. (Pfizer). BIIB104 is a first-in-class, Phase 2b ready AMPA
`receptor potentiator for CIAS, representing our first program in neurocognitive disorders. AMPA receptors mediate fast excitatory synaptic transmission in
`the central nervous system, a process which can be disrupted in a number of neurological and psychiatric diseases, including schizophrenia.
`Neurimmune SubOne AG
`In May 2018 we made a $50.0 million payment to Neurimmune SubOne AG (Neurimmune) under the terms of our amended collaboration and
`license agreement with Neurimmune (as amended, the Neurimmune Agreement) to reduce the previously negotiated royalty rates payable on products
`developed under the Neurimmune Agreement, including royalties payable on potential commercial sales of aducanumab, our anti-amyloid beta antibody
`candidate for the treatment of AD, by 5%. Our royalty rates payable on products developed under the Neurimmune Agreement, including royalties payable
`on potential commercial sales of aducanumab, will now range from the high single digits to sub-teens.
`Ionis Pharmaceuticals, Inc.
`In June 2018 we closed a 10-year exclusive agreement with Ionis Pharmaceuticals, Inc. (Ionis) to develop novel antisense oligonucleotide (ASO) drug
`candidates for a broad range of neurological diseases (the 2018 Ionis Agreement). We have the option to license therapies arising out of the 2018 Ionis
`Agreement and will be responsible for the development and potential commercialization of such therapies.
`TMS Co., Ltd. Option Agreement
`In June 2018 we entered into an exclusive option agreement with TMS Co., Ltd. (TMS) granting us the option to acquire TMS-007, a plasminogen
`activator with a novel mechanism of action (MOA) associated with breaking down blood clots, which is in Phase 2 development in Japan, and backup
`compounds for the treatment of stroke.
`Samsung Bioepis
`In June 2018 we exercised our option under our joint venture agreement with Samsung BioLogics to increase our ownership percentage in Samsung
`Bioepis from approximately 5% to approximately 49.9%. The share purchase transaction was completed in November 2018.
`BIIB110 Acquisition
`In July 2018 we acquired BIIB110 (formerly known as ALG-801) (Phase 1a) and ALG-802 (preclinical) from AliveGen Inc. (AliveGen). BIIB110 and ALG-
`802 represent novel ways of targeting the myostatin pathway. We initially plan to study BIIB110 in multiple neuromuscular indications, including SMA and
`ALS.
`BIIB067 Option Exercise
`In December 2018 we exercised our option with Ionis and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize
`BIIB067 (IONIS-SOD1Rx), an investigational treatment for ALS with superoxide dismutase 1 (SOD1) mutations.
`C4 Therapeutics
`In December 2018 we entered into a collaborative research and license agreement with C4 Therapeutics (C4T) to investigate the use of C4T’s novel
`protein degradation platform to discover and develop potential new treatments
`
`2
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`for neurological diseases, such as AD and Parkinson’s disease. We will be responsible for the development and potential commercialization of any
`therapies resulting from this collaboration.
`Skyhawk Therapeutics, Inc.
`In January 2019 we entered into a collaboration and research and development services agreement with Skyhawk Therapeutics, Inc. (Skyhawk)
`pursuant to which the companies will leverage Skyhawk’s SkySTAR technology platform with the goal of discovering innovative small molecule treatments
`for patients with neurological diseases, including MS and SMA. We will be responsible for the development and potential commercialization of any
`therapies resulting from this collaboration.
`
`Other Key DevelopmentsOther Key Developments
`ZINBRYTA Withdrawal
`In March 2018 we and AbbVie Inc. (AbbVie) announced the voluntary worldwide withdrawal of ZINBRYTA for RMS.
`IMRALDI
`In October 2018 we began to recognize revenues on sales of IMRALDI, an adalimumab biosimilar referencing HUMIRA, to third parties in the E.U. We
`and Samsung Bioepis previously entered into an agreement with AbbVie for the commercialization of IMRALDI. Under the terms of the agreement, AbbVie
`granted us and Samsung Bioepis patent licenses for the use and sale of IMRALDI in Europe, on a country-by-country basis, and we make royalty payments to
`AbbVie on behalf of Samsung Bioepis.
`2018 Share Repurchase Program
`In August 2018 our Board of Directors authorized a program to repurchase up to $3.5 billion of our common stock (2018 Share Repurchase
`Program). Our 2018 Share Repurchase Program does not have an expiration date. All share repurchases under our 2018 Share Repurchase Program will
`be retired.
`
`3
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`Table of Contents
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`Product and Pipeline DevelopmentsProduct and Pipeline Developments
`
`
`Core Growth AreasCore Growth Areas
`Multiple Sclerosis and Neuroimmunology
`TECFIDERA (dimethyl fumarate)
`• In April 2018 we presented new real-world data that demonstrated that people with RMS treated with TECFIDERA early in the course of their
`disease may experience better long-term outcomes. These data were presented at the 70th annual meeting of the American Academy of
`Neurology (AAN) in Los Angeles, CA.
`
`• In October 2018 we presented clinical and real-world evidence that further support the long-term efficacy and well characterized safety of
`TECFIDERA early within the disease course. These data were presented at the 34th Congress of the European Committee for Treatment and
`Research in MS (ECTRIMS) in Berlin, Germany.
`
`TYSABRI (natalizumab)
`• In April 2018, at the 70th annual meeting of the AAN in Los Angeles, CA, we presented new real-world data that demonstrated that people with
`RMS treated with TYSABRI early in the course of their disease may experience better long-term outcomes.
`
`• In April 2018 we presented observational data that demonstrated that extended interval dosing with TYSABRI is associated with a significant
`reduction in the risk of progressive multifocal leukoencephalopathy (PML), a serious brain injury, compared with standard interval dosing in the
`TOUCH prescribing program. These data were presented at the 70th annual meeting of the AAN in Los Angeles, CA. In November 2018 we
`initiated the Phase 3b NOVA study evaluating the efficacy and safety of extended interval dosing (every six weeks) for natalizumab compared to
`standard interval dosing in patients with RMS and enrolled the first patient in December 2018.
`
`• In October 2018 we presented clinical and real-world evidence that further support the long-term efficacy and well characterized safety of
`TYSABRI early within the disease course. These data were presented at the 34th Congress of ECTRIMS in Berlin, Germany.
`
`PLEGRIDY (peginterferon beta-1a)
`• In December 2018 we dosed the first patient in a bioequivalence study to test whether exposure levels of PLEGRIDY are maintained with
`intramuscular administration.
`
`ZINBRYTA (daclizumab)
`• In March 2018 we and AbbVie announced the voluntary worldwide withdrawal of ZINBRYTA for RMS.
`
`BIIB098 (formerly known as ALKS 8700) (diroximel fumarate; DRF)
`• In April 2018 MRI and relapse results from the Phase 3 EVOLVE-MS-1 study for diroximel fumarate in patients with relapsing remitting MS (RRMS)
`were presented at the 70th annual meeting of the AAN in Los Angeles, CA.
`
`• In December 2018 Alkermes Pharma Ireland Limited, a subsidiary of Alkermes plc (Alkermes), submitted a New Drug Application (NDA) to the
`U.S. Food and Drug Administration (FDA) for diroximel fumarate. Alkermes is seeking approval of diroximel fumarate under the 505(b)(2)
`regulatory pathway. If approved, we intend to market diroximel fumarate under the brand name VUMERITY. This name has been conditionally
`accepted by the FDA and will be confirmed upon approval.
`
`Opicinumab (anti-LINGO)
`• In September 2018 we completed enrollment of the Phase 2b AFFINITY study, evaluating opicinumab as an add-on therapy in MS patients who
`are adequately controlled on their anti-inflammatory disease-modifying therapy (DMT), versus the DMT alone.
`
`4
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`Neuromuscular Disorders
`SPINRAZA (nusinersen)
`• In February 2018 the end of study results from CHERISH, the Phase 3 study evaluating SPINRAZA for the treatment of individuals with later-onset
`SMA, were published in The New England Journal of Medicine. Results from CHERISH demonstrated meaningful motor function and upper limb
`improvements in individuals with later-onset SMA rarely seen in the natural course of the disease, which is typically a continued decline in motor
`function over time.
`
`• In March 2018 we presented new interim Phase 2 results from NURTURE, the ongoing open-label, single-arm study evaluating the efficacy and
`safety of SPINRAZA among pre-symptomatic infants with SMA. In NURTURE, all infants treated with SPINRAZA were alive, did not require
`permanent ventilation and showed improvement in motor function and motor milestone achievements as of July 5, 2017, compared to the
`disease's natural history. We also presented a case series demonstrating SPINRAZA's effectiveness among teens and young adults. These data
`were presented at the Muscular Dystrophy Association Clinical Conference in Arlington, VA.
`
`• In April 2018 we presented data from the CS2/CS12 studies that demonstrated that with SPINRAZA treatment, older patients were able to walk
`longer distances while experiencing stable or less fatigue at the same time, in contrast to natural history. The study participants have Type 2 or
`Type 3 SMA and were ages 12 to 15 years at study enrollment.
`
`We also presented data on part one of the Phase 2 EMBRACE study as well as an interim analysis of the SHINE open-label extension study, which
`examined the longer-term safety and efficacy of SPINRAZA in infantile-onset SMA patients.
`
`These data were presented at the 70th annual meeting of the AAN in Los Angeles, CA.
`
`• In June 2018 we presented data from our SPINRAZA clinical development program for SMA at the Cure SMA 2018 Annual SMA Conference in
`Dallas, TX. Platform and poster presentations highlighted interim analyses from the SHINE and NURTURE studies, which assess SPINRAZA's safety
`and efficacy among those with infantile-onset SMA, and data on the utility of plasma phosphorylated neurofilament heavy chain (pNF-H) as a
`potential biomarker for SMA.
`
`• In October 2018 we presented new interim results from NURTURE, an ongoing open-label, single-arm efficacy and safety study of SPINRAZA in 25
`presymptomatic infants with SMA at the Annual Congress of the World Muscle Society held in Mendoza, Argentina. As of May 2018 all NURTURE
`study participants were alive and none required permanent ventilation, in contrast to the natural history of SMA. In addition, 100% of study
`participants achieved the motor milestone of sitting independently, 88% were able to walk with assistance and 77% were able to walk
`independently. All NURTURE study participants were older than 15 months at the time of the analysis.
`
`• In November 2018 we were awarded the 2018 International Prix Galien as Best Biotechnology Product for SPINRAZA. The prestigious honor
`marks the seventh Prix Galien for SPINRAZA, following country recognitions in the U.S., Germany, Italy, Belgium-Luxembourg, the Netherlands, and
`the U.K. The International Prix Galien is given every two years by Prix Galien International Committee members in recognition of excellence in
`scientific innovation to improve human health.
`
`BIIB089 - SMA
`
`• In May 2018 we submitted an Investigational New Drug Application for BIIB089 in SMA.
`
`• In October 2018 we announced that the FDA had placed BIIB089 on a clinical hold.
`
`BIIB078 (IONIS-C9Rx) - ALS
`• In September 2018 we enrolled the first patient in the Phase 1 study evaluating BIIB078, an ASO drug candidate, in adults with C9ORF72-
`associated ALS.
`
`BIIB067 (IONIS-SOD1Rx) - ALS
`• In December 2018 we and Ionis announced results from a positive interim analysis of the ongoing Phase 1 study of BIIB067 in ALS with SOD1
`mutations. The interim analysis showed that, over a three month period,
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 9
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 9
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`Table of Contents
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`BIIB067 resulted in a statistically significant lowering of SOD1 protein levels in the cerebrospinal fluid and a numerical trend towards slowing of
`clinical decline as measured by the ALS Functional Rating Scale Revised, both compared to placebo.
`
`Alzheimer's Disease and Dementia
`Aducanumab (Aβ mAb)
`• In February 2018 we announced that, following a pre-planned blinded sample size review of the data per study protocol and based on variability
`in the primary endpoint that was greater than study protocol assumed, we increased the sample size of ENGAGE and EMERGE, the Phase 3
`studies of aducanumab.
`
`• In March 2018 we presented data from the long-term extension (LTE) of the Phase 1b PRIME study of aducanumab at the Advances in
`Alzheimer's and Parkinson's Therapies (AAT-AD/PD) Focus Meeting in Torino, Italy. The data presentation included the Centiloid scale, a method
`used to standardize the aducanumab Phase 1b PRIME study amyloid-PET (positron emission tomography) results as previously measured by the
`composite Standardized Uptake Value Ratio.
`
`• In April 2018 we presented 36-month data and 24-month titration data from the Phase 1b PRIME study of aducanumab at the 70th annual
`meeting of the AAN in Los Angeles, CA.
`
`• In July 2018 we completed enrollment of ENGAGE and EMERGE, the Phase 3 studies of aducanumab.
`
`• In July 2018 we presented a new analysis from the Phase 1b PRIME study of aducanumab at the Alzheimer's Association International
`Conference (AAIC) 2018 in Chicago, IL. These data included a poster presentation on the 24-month analysis of APOE ε4 carriers in the Phase 1b
`PRIME study and a platform presentation on the 24-month clinical dementia rating scale analysis of the Phase 1b PRIME study.
`
`• In August 2018 we and our collaboration partner Eisai Co., Ltd. (Eisai) announced results from a recent analysis of the ongoing LTE of the Phase
`1b PRIME study of aducanumab. The updated analyses include data from the placebo-controlled period and LTE for patients treated with
`aducanumab up to 36 months in the titration cohort and up to 48 months in the fixed dose cohorts. The results are generally consistent with
`previous interim analyses, and there were no changes to the risk-benefit profile of aducanumab.
`
`• In October 2018 we presented data on the efficacy of aducanumab and the cumulative safety data from the LTE of the Phase 1b PRIME study of
`patients with prodromal and mild Alzheimer's disease. These data were presented at the Clinical Trials on Alzheimer's Disease (CTAD) annual
`meeting in Barcelona, Spain. These results are generally consistent with previous interim analyses, and there were no changes to the risk-benefit
`profile of aducanumab.
`
`• In November 2018 we initiated a Phase 2 study of aducanumab to assess the clinical relevance of asymptomatic amyloid related imaging
`abnormalities (ARIA). This Phase 2 study was not required by regulators and is not necessary for registration.
`
`BAN2401 (Aβ mAb)
`• In December 2017 we and our collaboration partner Eisai announced that the Phase 2 study of BAN2401, a monoclonal antibody that targets
`amyloid beta aggregates, an Eisai product candidate for the treatment of AD, did