Table of Contents
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`UNITED STATES SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`Form 10-K
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2013
`
`or
`
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`Commission file number: 0 19311
`
`BIOGEN IDEC INC.
`
`(Exact name of registrant as specified in its charter)
`
`
`
`Delaware
`(State or other jurisdiction of
`
`incorporation or organization)
`225 Binney Street, Cambridge, Massachusetts 02142
`(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:
`
`33-0112644
`(I.R.S. Employer
`Identification No.)
`
`
`Name of Each Exchange on Wh ch Reg stered
`T tle of Each Class
`
`The Nasdaq Global Select Market
`Common Stock, $0.0005 par value
`Securities registered pursuant to Section 12(g) of the Act:
`None
`Indicate by check mark if the registrant is a well known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes  No ¨
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ¨ No 
`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  No ¨
`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  No ¨
`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 0 K or any amendment
`to this Form 10 K. 
`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 2b 2 of the Exchange Act
`
`Accelerated filer ¨
`
`Large accelerated filer 
`
`
`Non accelerated filer ¨
` Smaller reporting company ¨
`
`
`
`
`(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 ¨ No 
`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 $51,089,367,313.
`As of January 31, 2014, the registrant had 236,393,930 shares of common stock, $0.0005 par value, outstanding.
`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive proxy statement for our 20 4 Annual Meeting of Stockholders are incorporated by reference into Part III of this report
`
`
`
`Biogen Exhibit 2113
`Mylan v. Biogen
`IPR 2018-01403
`
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`
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`
`
`BIOGEN IDEC INC.
`ANNUAL REPORT ON FORM 10 K
`For the Year Ended December 31, 2013
`TABLE OF CONTENTS
`
`PART I
`
`Page
`
`Item
`Item A
`Item B
`Item 2
`Item 3
`Item 4
`
`
`Item 5
`Item 6
`Item 7
`Item 7A
`Item 8
`Item 9
`Item 9A
`Item 9B.
`
`
`Item 0
`Item 11
`Item 2
`Item 3
`Item 4
`
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`PART 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 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
`
`Item 15.
`
`Signatures
`Consolidated Financial Statements
`Exhibit Index
`
`PART IV
`
`1
`22
`33
`33
`34
`34
`
`35
`37
`39
`70
`71
`71
`71
`72
`
`73
`73
`73
`73
`73
`
`74
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`75
`F
`A
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`NOTE REGARDING FORWARD LOOKING STATEMENTS
`This report contains forward looking statements that are based on our current beliefs and expectations The following cautionary statements 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, doubtful accounts, pre approval inventory, cost of sales, research and development costs,
`compensation and other expenses, amortization of intangible assets, and foreign currency forward contracts;
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
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`•
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`•
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`•
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`•
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`•
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`•
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`•
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`•
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`•
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`•
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`•
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`•
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`the anticipated timing of commercial launches of TECFIDERA in European countries;
`
`anticipated regulatory filings and regulatory actions relating to, and commercial launch of, ELOCTATE and ALPROLIX;
`
`additional anticipated commercial launches of FAMPYRA and the timing thereof;
`
`patent terms, patent term extensions, patent office actions, and expected availability and period of data protection and market exclusivity rights;
`
`the potential impact of increased product competition in the multiple sclerosis (MS) market, including competition from and growth of our own products
`and the possibility of future competition from biosimilars, generic versions or related prodrug derivatives;
`
`the potential for increased competition between RITUXAN and GAZYVA in the oncology market;
`
`our plans to develop further risk stratification protocols and therapies for TYSABRI and the impact of such protocols;
`
`the timing, outcome and impact of administrative, regulatory, litigation and other proceedings related to patents and other proprietary and intellectual
`property rights, tax audits, assessments and settlements, product liability and other matters;
`
`the impact of the commercial launch of TECFIDERA on sales and market share of our products;
`
`the expected timing and financial impact of the final approval of the settlement of our dispute with the Italian National Medicines Agency relating to sales
`of TYSABRI;
`
`the anticipated lifetime revenues of AVONEX and TYSABRI and amortization recorded in relation to their technology;
`
`the costs, timing, potential approval and therapeutic scope of the development and commercialization of our pipeline products;
`
`lease commitments and purchase obligations;
`
`the potential impact of budget cuts and other measures in the U S and worldwide designed to reduce healthcare costs to constrain the overall level of
`government expenditures, including the impact of pricing actions in Europe and elsewhere;
`
`the impact of the continued uncertainty and deterioration of the credit and economic conditions in certain countries in Europe and our collection of
`accounts receivable in such countries;
`
`our ability to finance our operations and business initiatives and obtain funding for such activities;
`
`the impact of new laws and accounting standards;
`
`the expected timing of completion of our manufacturing obligation for Zevalin;
`
`manufacturing capacity and our intent to utilize third party contract manufacturing organizations to provide manufacturing services for our small
`molecule products; and
`
`the drivers for growing our business, including our plans to pursue business development and research opportunities, and competitive conditions.
`
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`These forward looking statements involve risks and uncertainties, including those that are described in the “ Risk Factors” section of this report and
`elsewhere within 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 We do not undertake any obligation to publicly update any forward
`looking statements
`
`NOTE REGARDING COMPANY AND PRODUCT REFERENCES
`Throughout this report, “Biogen Idec,” the “Company,” “we,” “us” and “our” refer to Biogen Idec Inc and its consolidated subsidiaries References to
`“RITUXAN” refer 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 “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 TRADEMARKS
`AVONEX®, AVONEX PEN®, AVOSTARTGRIP®, RITUXAN®, TECFIDERA®, TYSABRI® and TOUCH® are registered trademarks of Biogen Idec
`ALPROLIXTM, ELOCTATETM, FUMADERMTM and PLEGRIDYTM are trademarks of Biogen Idec The following are trademarks of the respective
` Sanofi Societe Anonyme France; ANGIOMAX ® and
`companies listed: ACTEMRA®
` Chugai Seiyaku Kabushiki Kaisha; AUBAGIO ®
` The Medicines Company; ARZERRA ®
` Glaxo Group Limited; BENLYSTA®
`ANGIOXTM
` GlaxoSmithKline Intellectual Property Limited;
` Genzyme Corporation; CIMZIA ®
` UCB Pharma, S.A.;
`BETASERON® and BETAFERON®
` Bayer Schering Pharma AG; LEMTRADA ®
` Immunex Corporation; EXTAVIA® and GILENYA®
` Novartis AG;
`COPAXONE®
` Teva Pharmaceutical Industries Limited; ENBREL®
`FAMPYRA®
` Acorda Therapeutics, Inc.; GAZYVATM
` AbbVie Biotechnology Ltd ; ORENCIA®
` Bristol Myers
` Genentech, Inc ; HUMIRA ®
` Janssen Biotech, Inc.; SIMPONI ® and SIMPONI ARIA TM
` Johnson & Johnson;
`Squibb Company; REBIF®
` Ares Trading S.A.; REMICADE®
`TREANDA®
` Cephalon, Inc.; and XELJANZ ®
` Pfizer Inc
`
`Page 4 of 175
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`Table of Contents
`
`Item 1.
`
`Business
`
`PART I
`
`Overview
`Biogen Idec is a global biotechnology company focused on discovering, developing, manufacturing and marketing therapies for the treatment of multiple
`sclerosis (MS) and other autoimmune disorders, neurodegenerative diseases and hemophilia We also collaborate on the development and commercialization of
`RITUXAN for the treatment of non Hodgkin's lymphoma, chronic lymphocytic leukemia and other conditions and share profits and losses for GAZYVA for
`the treatment of chronic lymphocytic leukemia Summary information about our marketed products is set forth in the table below
`
`
`
` Indications
` Multiple sclerosis
`Multiple sclerosis
`
`Crohn’s disease
` Multiple sclerosis
`Multiple sclerosis
`
`(walking ability)
` Psoriasis
`
`
`Deve opmen or
`
`Market ng Collaborator
` None
`None
`
`
` None
`Acorda Therapeutics
`
`
` None
`
`
`
`Produc
`AVONEX (1)
`TYSABRI (2)
`
`TECFIDERA (3)
`FAMPYRA (4)
`
`FUMADERM (5)
`
`
`
`RITUXAN (6)
`
`
`
`Product Revenues
`o Biogen Idec (in millions)
`
`
`2012
`2,913.1 $
`1,135.9
`$
`
`
`2013
`3,005.5 $
`1,526.5
`$
`
`
`876.1 $
`$
`74 0
`
`
` $
`$
`
`
` $
`$
`
`
` $
`
`
` $
`$
`
`57.4
`
`
`
`59.7 $
`60.2 $
`Unconso ida ed Join Business
`Revenues o B ogen Idec ( n m ons)
`
`
`2012
`1,137.9
`
`2011
`2,686.6
`1,079.5
`
`13.6
`
`54.7
`
`2011
`996.6
`
`
`
`Non Hodgkin’s lymphoma
`Rheumatoid arthritis
`Chronic lymphocytic leukemia
`ANCA associated vasculitis
`
`
`
`
`
`Genentech
`(Roche Group)
`
`
`
`$
`
`
`
`
`
`
`2013
`1,126.0
`
`$
`
`$
`
`
`
`
`
`( ) AVONEX (interferon beta 1a), injection for intramuscular use, is indicated for the treatment of patients with relapsing forms of MS to slow the
`accumulation of physical disability and decrease the frequency of clinical exacerbations
`
`(2) TYSABRI (natalizumab), injection for intravenous infusion, is indicated (1) as a monotherapy for the treatment of patients with relapsing forms of MS
`to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations and (2) in the U.S. for inducing and maintaining
`clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an
`inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies and TNF inhibitors
`
`We previously collaborated with Elan Pharma International, Ltd (Elan), an affiliate of Elan Corporation, plc on the development, manufacture
`and commercialization of TYSABRI. On April 2, 2013, we acquired full ownership of, and strategic, commercial and decision making rights to,
`TYSABRI Upon the closing of the transaction, our collaboration agreement with Elan was terminated
`
`(3) TECFIDERA (dimethyl fumarate), delayed release capsules for oral use, is indicated for the treatment of patients with relapsing forms of MS
`TECFIDERA was approved by the U.S. Food and Drug Administration (FDA) in March 2013. In February 2014, the European Commission (EC)
`approved the use of TECFIDERA in the European Union (E U ) as a first line oral treatment for people with relapsing remitting MS
`
`(4) FAMPYRA (prolonged release fampridine tablets) is indicated for the improvement of walking ability in adult patients with MS who have walking
`disability.
`
`(5) FUMADERM (fumaric acid esters), prolonged release tablets , is only approved in Germany and is indicated for the treatment of adult patients with
`moderate to severe plaque psoriasis for whom topical therapy is ineffective
`
`(6) RITUXAN (rituximab), injection for intravenous infusion, is indicated for the treatment of (1)(a) relapsed or refractory, low grade or follicular, CD20
`positive, B cell Non Hodgkin's lymphoma (NHL) as a single agent, (b) previously untreated follicular, CD20 positive, B cell NHL in combination with
`first line chemotherapy and, in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as a single agent
`maintenance therapy, (c) non progressing (including stable disease), low grade, CD20 positive, B cell NHL, as a single agent, after first line CVP
`chemotherapy, and (d) previously untreated diffuse large B cell, CD20 positive NHL in combination with CHOP or
`
`1
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`other anthracycline based chemotherapy regimens, (2) patients with CD20 positive chronic lymphocytic leukemia in combination with fludarabine and
`cyclophosphamide, (3) moderately to severely active rheumatoid arthritis, in combination with methotrexate, in adult patients who have had an
`inadequate response to one or more TNF antagonist therapies, and (4) Wegener's Granulomatosis and Microscopic Polyangiitis, in combination with
`glucocorticoids, in adult patients.
`
`Additional financial information about our product revenues, other revenues, significant customers and geographic areas in which we operate is set forth
`in our consolidated financial statements, in Note 25, Segment Information to our consolidated financial statements, and in Item 6. Selected Financial Data
`and in 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
`
`We devote significant resources to research and development programs and external business development opportunities, as summarized in the table
`be ow:
`
`(In millions)
`Research and development
`Amortization of acquired intangible assets
`(Gain) loss on fair value remeasurement of contingent consideration
`
`
` $
` $
` $
`
`
`2013
`1,444.1 $
`342.9 $
`(0.5) $
`
`
`2012
`1,334.9 $
`202.2 $
`27.2 $
`
`
`2011
`1,219.6
`208.6
`36.1
`
`Additional information about our research and development programs and business development activity during 2013 is set forth below under the
`subsections entitled “Research and Development Programs” and “Business Development.”
`
`We were formed as a California corporation in 1985 and became a Delaware corporation in 1997 In 2003, we acquired Biogen, Inc and changed our
`corporate name from IDEC Pharmaceuticals Corporation to Biogen Idec Inc Our principal executive offices are located at 225 Binney Street, Cambridge, MA
`02142 and our telephone number is (617) 679 2000 Our website address is www biogenidec com We make available free of charge through the Investors
`section of our website our Annual Reports on Form 10 K, Quarterly Reports on Form 10 Q, Current Reports on Form 8 K and all amendments to those reports
`as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission (SEC) We include
`our website address in this report only as an inactive textual reference and do not intend it to be an active link to our website The contents of our website are
`not incorporated into this report
`
`Marketed Products
`MS Products
`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
`
`AVONEX
`AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide AVONEX is a recombinant form of the interferon beta protein
`produced in the body in response to viral infection In February 2012, the FDA approved two separate dosing innovations designed to improve the treatment
`experience for patients receiving once a week AVONEX for relapsing forms of MS: AVONEX PEN and a new dose titration regimen AVONEX PEN is the
`first intramuscular autoinjector approved for MS and is designed to enhance the self injection process for patients receiving AVONEX therapy The dose
`titration regimen, facilitated by the AVOSTARTGRIP titration devices, provides patients with the option to gradually increase the dose of AVONEX at treatment
`initiation to reduce the incidence and severity of flu like symptoms that patients may experience with therapy These AVONEX dosing innovations are
`commercially available in the E.U., U.S. and other countries, and were recently approved for marketing in Japan.
`
`TYSABRI
`TYSABRI has advanced the treatment of relapsing MS with its established efficacy. TYSABRI is a monoclonal antibody approved in numerous
`countries as a monotherapy for relapsing MS and is also approved in the U.S. to treat Crohn's disease, an inflammatory disease of the intestines.
`
`2
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`TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic infection of the brain by the JC virus (JCV) that
`usually leads to death or severe disability Infection by the JC virus is required for the development of PML and patients who are anti JCV antibody positive
`have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti JCV antibodies, prior immunosuppressant use, and longer
`TYSABRI treatment duration Patients who have all three risk factors have the highest risk of developing PML Reports of cases of PML in patients treated
`with TYSABRI in clinical studies led us to voluntarily suspend the marketing and commercial distribution of TYSABRI in February 2005 until its
`reintroduction to the market in July 2006. Because of the risk of PML, TYSABRI has a boxed warning and is marketed under risk management or
`minimization plans approved by regulatory authorities. In the U.S., for example, TYSABRI is marketed under the TOUCH Prescribing Program, a restricted
`distribution program designed to assess and minimize the risk of PML, minimize death and disability due to PML, and promote informed benefit risk
`decisions regarding TYSABRI use
`
`U.S. and E.U. regulators continue to monitor and assess on an ongoing basis the criteria for confirming PML diagnosis, the number of PML cases, the
`incidence of PML in TYSABRI patients, the risk factors for PML, and TYSABRI's benefit risk profile, which could result in modifications to the approved
`labels or other restrictions on TYSABRI treatment We continue to research and develop protocols and therapies that may reduce risk and improve outcomes of
`PML in patients.
`
`In 2012, the FDA approved the inclusion in the U.S. product label for TYSABRI of anti JCV antibody status as an additional factor in stratifying
`patients for developing PML and a table summarizing the estimated incidence of PML according to the duration of TYSABRI treatment, prior
`immunosuppressant use and anti JCV antibody status. In addition, the FDA granted Quest Diagnostics a de novo classification petition for the STRATIFY
`JCV Antibody ELISA testing service, which allows neurologists to determine their MS patients' anti JCV antibody status A second generation assay capable
`of detecting JCV antibodies at lower concentrations than the original assay, known as STRATIFY DX SELECT JCV Antibody ELISA, has also been
`developed
`
`2013 Developments
`• We previously collaborated with Elan on the development, manufacture and commercialization of TYSABRI On April 2, 2013, we acquired full
`ownership of, and strategic, commercial and decision making rights to, TYSABRI from Elan, for an upfront payment of $3.25 billion together with an
`agreement to make contingent payments to Elan Upon the closing of the transaction, our collaboration agreement with Elan was terminated For
`additional information related to this relationship, please read Note 2, Acquisitions and Note 20, Collaborative and Other Relationships to our
`consolidated financial statements included within this report
`In 2013, the FDA and the European Medicines Agency (EMA) approved updates to the TYSABRI product labels In July 2013, the EMA approved an
`expanded indication statement for TYSABRI to include glatiramer acetate (GA) treatment failures in the definition of non responders eligible for
`TYSABRI, and in December 2013, the FDA approved a modification to the indication statement in the U S product label for TYSABRI clarifying the
`intended use of TYSABRI for people living with relapsing forms of MS, as well as updates to certain safety information In May 2013, we withdrew the
`variation in our application we submitted to the EMA requesting to expand the indication statement to allow first line use of TYSABRI for people living
`with certain relapsing forms of MS who have tested negative for antibodies to the JC virus
`In 2013, we submitted an application for approval of TYSABRI in Japan.
`
`•
`
`•
`
`TECFIDERA
`TECFIDERA is our first line oral treatment for people with relapsing forms of MS TECFIDERA was approved by the FDA in March 2013 and by
`regulatory authorities in Canada and Australia in April 2013 and July 2013, respectively In February 2014, the EC approved the use of TECFIDERA in the
`E U as a first line oral treatment for people with relapsing remitting MS TECFIDERA is also currently under review by regulatory authorities in additional
`markets.
`
`We acquired TECFIDERA as part of our acquisition of Fumapharm AG in 2006 For more information about this acquisition and associated milestone
`obligations, please read the subsection entitled “ Contractual Obligations and Off Balance Sheet Arrangements Contingent Consideration related to
`Business Combinations” of our “Management’s Discussion and Analysis of Financial Condition and Results of Operations .”
`
`FAMPYRA
`FAMPYRA is the first treatment that addresses the unmet medical need of walking improvement in adult patients with MS who have walking disability
`FAMPYRA is a prolonged release tablet formulation of the drug fampridine FAMPYRA has been approved in over 50 countries across Europe, Asia and the
`Americas, and we anticipate making FAMPYRA commercially available in additional markets in 2014
`
`3
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`We have a license from Acorda Therapeutics, Inc to develop and commercialize FAMPYRA in all markets outside the U S For information about this
`relationship, please read Note 20, Collaborative and Other Relationships to our consolidated financial statements included in this report
`
`•
`
`2013 Developments
`The EC granted a conditional marketing authorization for FAMPYRA in the E U in July 2011 A conditional marketing authorization is renewable
`annually and is granted to a medicinal product with a positive benefit risk assessment that fulfills an unmet medical need when the benefit to public
`health of immediate availability outweighs the risk inherent in the fact that additional data are still required This marketing authorization was renewed
`as of July 2013 To meet the conditions of this marketing authorization, we will continue to provide additional data from on going clinical studies
`regarding FAMPYRA's benefits and safety
`
`Other Products
`
`FUMADERM
`FUMADERM is approved for the treatment of moderate to severe plaque psoriasis in Germany Psoriasis is a skin disease in which cells build up on the
`skin surface and form scales and red patches.
`RITUXAN
`RITUXAN is a widely prescribed monoclonal antibody used to treat non Hodgkin's lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia
`and two forms of ANCA associated vasculitis. Non Hodgkin's lymphoma and chronic lymphocytic leukemia are cancers that affect lymphocytes, which are
`a type of white blood cell that help to fight infection Rheumatoid arthritis is a chronic disease that occurs when the immune system mistakenly attacks the
`body's joints, resulting in inflammation, pain and joint damage. ANCA associated vasculitis is a rare autoimmune disease that largely affects the small blood
`vessels of the kidneys, lungs, sinuses, and a variety of other organs.
`
`In the U S , we collaborate with Genentech, Inc (Genentech), a wholly owned member of the Roche Group, on the development and commercialization of
`RITUXAN For information about this collaboration, please read Note 20, Collaborative and Other Relationships to our consolidated financial statements
`included in this report.
`
`GAZYVA
`GAZYVA (obinutuzumab), injection for intravenous infusion, in combination with chlorambucil, is indicated for the treatment of patients with
`previously untreated chronic lymphocytic leukemia The FDA granted GAZYVA breakthrough therapy designation due to the significance of the positive
`progression free survival results from the Phase 3 CLL11 clinical trial and the serious and life threatening nature of CLL GAZYVA, formerly known as
`GA101, was approved by the FDA in November 2013.
`
`In the U S , we share operating profits and losses relating to GAZYVA with Genentech The Roche Group and its sub licensees maintain sole
`responsibility for the development, manufacturing and commercialization of GAZYVA in the U S For information about our agreement with Genentech,
`please read Note 20, Collaborative and Other Relationships to our consolidated financial statements included in this report
`
`Other Sources of Revenue
`Our other sources of revenue consist of royalties we receive from net sales of products related to patents that we licensed (royalty revenues) and revenues
`from our contract manufacturing, product supply and biosimilar arrangements (corporate partner revenues). Summary information about our other sources of
`revenue is set forth in the table below:
`
`(In millions)
`Royalty revenues
`Corporate partner revenues
`
`
`
`
`
`$
`$
`
`2013
`
`
`185.7 $
`78.2 $
`
`2012
`
`
`168.7 $
`43 8 $
`
`2011
`
`158.5
`57.4
`
`4
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`Our most significant source of royalty revenue is derived from net worldwide sales of ANGIOMAX, which is licensed to The Medicines Company
`(TMC). TMC markets ANGIOMAX primarily in the U.S. and Europe for use as an anticoagulant in patients undergoing percutaneous coronary intervention.
`Under the terms of our royalty arrangement for ANGIOMAX, TMC is obligated to pay us royalties earned, on a country by country basis, until the later of
`(1) twelve years from the date of the first commercial sale of ANGIOMAX in such country or (2) the date upon which the product is no longer covered by a
`licensed patent in such country The annual royalty rate is reduced by a specified percentage in any country where the product is no longer covered by a
`licensed patent and where sales have been reduced to a certain volume based market share TMC began selling ANGIOMAX in the U S in January 2001 In
`March 2012, the U.S. Patent and Trademark Office granted the extension of the term of the principal U.S. patent that covers ANGIOMAX to December 15,
`20 4 We expect royalty revenue to decrease significantly when the term of the U S patent covering ANGIOMAX expires For a further description of our
`royalty arrangement with TMC, please read the subsection entitled “ Other Revenues Royalty Revenues” in the “Management's Discussion and Analysis
`of Financial Condition and Results of Operations ” section of this report
`
`Research and Development Programs
`A commitment to research is fundamental to our mission at Biogen Idec Our research and development strategy is to discover and develop first in class
`molecules or best in class molecules that improve safety or efficacy for unmet medical needs By applying our expertise in biologics and our growing
`capabilities in small molecule and anti sense drug discovery and development, we target specific medical needs where new or better treatments are needed
`
`We intend to continue committing significant resources to research and development opportunities As part of our ongoing research and development
`efforts, we have devoted significant resources to conducting clinical studies to advance the development of new pharmaceutical products and to explore the
`utility of our existing products in treating disorders beyond those currently approved in their labels The table below highlights our current research and
`development programs that are in clinical trials Drug development involves a high degree of risk and investment, and the status, timing and scope of our
`development programs are subject to change Important factors that could adversely affect our drug development efforts are discussed in the “ Risk Factors”
`section of this report
`
`Therapeutic Area
`Neu ology
`
`
`
`
`
`
`
`
`
`
`Hemoph a
`
`
`mmuno ogy
`
`
`O he
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Product Cand date
`PLEGRIDY (peg n e fe on be a-1a)
`
`Dacl zumab H gh Y eld P ocess (HYP)
`
`TYSABRI
`
`An -LINGO
`
`Neub as n
`BIIB037
`ISIS - SMNRx
`BIIB061
`
`ALPROLIX Coag a o Fac o IX, Fc
`Fus on P o e n (Recomb nan )]
`ELOCTATE (An hemoph c Fac o ,
`Fc Fus on P o e n (Recomb nan )]
`STX-100
`An -TWEAK
`An -CD40 L gand
`
`GAZYVA (ob
`
`z
`
`ab)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Targe ed Ind ca ons
`MS
`
`MS
`
`s
`
`Seconda y p og ess ve MS
`S oke
`Op c Neu
`MS
`Neu opa h c pa n
`A zhe me ’s d sease
`Sp na muscu a a ophy
`MS
`
`Hemoph a B
`
`Hemoph a A
`
`Id opa h c pulmona y f b os s
`L p s ep
`t s
`Ge e a p s
`
`Non-Hodgk n’s ymphoma
`
`5
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Collabo a or
`None
`
`AbbV e
`B o he apeu cs
`None
`None
`None
`None
`None
`None
`Is s Pha maceu cals
`None
`
`Swed sh O phan
`B ov um
`Swed sh O phan
`B ov um
`None
`None
`UCB, I c
`
`Genen ech (Roche
`G oup)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Status
`g
`U S BLA a d EMA a ke
`au ho sa on appl ca on subm ed and
`unde egu a o y ev ew
`P ase 3
`
`P ase 3
`P ase 2
`P ase 2
`P ase 2
`P ase 2
`Phase 1b
`Phase 1b/2a
`Phase 1
`
`U S BLA s
`egula o y ev ew
`U S BLA s
`egula o y ev ew
`Phase 2a
`P ase 2
`Phase 1
`
`P ase 3
`
`tted a d
`
`tted a d
`
`de
`
`de
`
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`Table of Contents
`
`Late Stage Product Candidates
`