`
`
`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, 2014
`
`Commission File Number 1-1136
`_______________
`BRISTOL-MYERS SQUIBB COMPANY
`(Exact name of registrant as specified in its charter)
`________________
`
`Delaware
`(State or other jurisdiction of
`incorporation or organization)
`
` 
`
`22-0790350
`(IRS Employer
`Identification No.)
`
` 
`345 Park Avenue, New York, N.Y. 10154
`(Address of principal executive offices)
`Telephone: (212) 546 -4000
`Securities registered pursuant to Section 12(b) of the Act:
`
`Name of each exchange on which registered
`Title of each class
`Common Stock, $0.10 Par Value
`New York Stock Exchange
` 
`Securities registered pursuant to Section 12(g) of the Act:
`
` 
`
`Title of each class
`$2 Convertible Preferred Stock, $1 Par Value
`_________________
`
`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 Section 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 (§232.405 of this chapter) 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 (§229.405 of this chapter) 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.     ⌧⌧⌧⌧
`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 definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. 
`
`Large accelerated filer   ⌧⌧⌧⌧
`
`   Accelerated filer   ¨¨¨¨
`
`   Non-accelerated filer   ¨¨¨¨
`
`   Smaller reporting company   ¨¨¨¨
`
`Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨¨¨¨    No   ⌧⌧⌧⌧
`The aggregate market value of the 1,655,998,321 shares of voting common equity held by non-affiliates of the registrant, computed by reference
`to the closing price as reported on the New York Stock Exchange, as of the last business day of the registrant’s most recently completed second fiscal
`quarter (June 30, 2014) was approximately $80,332,478,552. Bristol-Myers Squibb has no non-voting common equity. At February 2, 2015, there were
`1,662,118,446 shares of common stock outstanding.
`
`DOCUMENTS INCORPORATED BY REFERENCE: Portions of the Proxy Statement for the registrant’s Annual Meeting of Stockholders to
`be held May 5, 2015 are incorporated by reference into Part III of this Annual Report on Form 10 -K.
`
`
`
`
`BMS 2009
`CFAD v. BMS
`IPR2015-01723
`
`Page 1
`
`

`

`
`
`
`PART I
`
`BUSINESS.
`
`Item 1.
`
`General
`
`Bristol-Myers Squibb Company (which may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us) was incorporated under the
`laws of the State of Delaware in August 1933 under the name Bristol-Myers Company, as successor to a New York business started in 1887. In
`1989, Bristol-Myers Company changed its name to Bristol-Myers Squibb Company as a result of a merger. We are engaged in the discovery,
`development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis.
`
`We operate in one segment—BioPharmaceuticals. For additional information about business segments, see “Item 8. Financial Statements—Note 2.
`Business Segment Information.”
`
`We compete with other worldwide research-based drug companies, smaller research companies and generic drug manufacturers. Our products are
`sold worldwide, primarily to wholesalers, retail pharmacies, hospitals, government entities and the medical profession. We manufacture products in
`the United States (U.S.), Puerto Rico and in six foreign countries.
`
`The percentage of revenues by significant region/country were as follows:
`
` 
`
`Dollars in Millions
`51%  
`49%  
`United States
`24%  
`23%  
`Europe
`5%  
`6%  
`Japan
`4%  
`4%  
`China
`             
`Total Revenues
`  $
`  $
`  $
`15,879
`16,385
`
`Acquisitions and Divestitures
`
`We continue to transform BMS into a leading-edge biopharmaceutical company focused exclusively on discovering, developing, and delivering
`innovative medicines that address serious unmet medical needs. This transformation has encompassed all areas of our business and operations.
`As part of this strategy, we have divested our diabetes and non-pharmaceutical businesses, implemented our acquisition and licensing strategy,
`and executed our productivity transformation initiative (PTI). Our divestitures included our diabetes business in February 2014, Mead Johnson in
`December 2009, ConvaTec in August 2008 and Medical Imaging in January 2008. As part of our acquisition and licensing strategy, we acquired
`iPierian, Inc. (iPierian) in April 2014, Amylin Pharmaceuticals, Inc. (Amylin) in August 2012, Inhibitex, Inc. (Inhibitex) in February 2012, Amira
`Pharmaceuticals, Inc. (Amira) in September 2011, ZymoGenetics, Inc. (ZymoGenetics) in October 2010 and Medarex, Inc. (Medarex) in September
`2009 and entered into several license and other collaboration arrangements. These transactions have allowed and continue to allow us to focus our
`resources behind our growth opportunities that drive the greatest long-term value. From a disease standpoint, we are focused on the following
`core therapeutic areas: oncology, virology, immunology, specialty cardiovascular disease, fibrosis and genetically defined diseases.
`
`Products
`
`Our pharmaceutical products include chemically-synthesized drugs, or small molecules, and an increasing portion of products produced from
`biological processes (typically involving recombinant DNA technology), called “biologics.” Small molecule drugs are typically administered orally,
`e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well. Biologics are typically administered to patients
`through injections or by infusion. Most of our revenues come from products in the following therapeutic classes: virology, including human
`immunodeficiency virus (HIV) infection; oncology; neuroscience; immunoscience; and cardiovascular.
`
`In the pharmaceutical industry, the majority of an innovative product’s commercial value is usually realized during the period in which the product
`has market exclusivity. Our business is focused on innovative biopharmaceutical products, and we rely on patent rights and various forms of
`regulatory protection to maintain the market exclusivity of our products. In the U.S., the European Union (EU) and some other countries, when
`these patent rights and other forms of exclusivity expire and generic versions of a medicine are approved and marketed, there are often substantial
`and rapid declines in the sales of the original innovative product. For further discussion of patent rights and regulatory forms of exclusivity, see
`“—Intellectual Property and Product Exclusivity” below. For further discussion of the impact of generic competition on our business, see “—
`Generic Competition” below.
`
`
`Year Ended December 31,
`2013
`
`2012
`
`2014
`
`59%
`21%
`4%
`3%
`
`17,621
`
`2
`
`Page 2
`
` 
` 
` 
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` 
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`

`

`
`
`The following chart shows our key products together with the year in which the earliest basic exclusivity loss (patent rights or data exclusivity)
`occurred or is currently estimated to occur in the U.S., the EU, Japan and China. We also sell our pharmaceutical products in other countries;
`however, data is not provided on a country-by-country basis because individual country revenues are not significant outside the U.S., the EU,
`Japan and China. In many instances, the basic exclusivity loss date listed below is the expiration date of the patent that claims the active ingredient
`of the drug or the method of using the drug for the approved indication, if there is only one approved indication. In some instances, the basic
`exclusivity loss date listed in the chart is the expiration date of the data exclusivity period. In situations where there is only data exclusivity without
`patent protection, a competitor could seek regulatory approval by submitting its own clinical trial data to obtain marketing approval prior to the
`expiration of data exclusivity.
`
`We estimate the market exclusivity period for each of our products for the purpose of business planning only. The length of market exclusivity for
`any of our products is impossible to predict with certainty because of the complex interaction between patent and regulatory forms of exclusivity
`and the inherent uncertainties regarding patent litigation. There can be no assurance that a particular product will enjoy market exclusivity for the
`full period of time that appears in the estimate or that the exclusivity will be limited to the estimate.
`
`The following schedule presents revenues of our key products and estimated basic exclusivity loss in the U.S., EU, Japan and China:
`
` 
`
`Dollars in Millions
`Virology
`Baraclude
`Hepatitis C Franchise(b)
`Reyataz
`Sustiva Franchise
`Oncology
`Erbitux*
`Opdivo
`Sprycel
`Yervoy
`Neuroscience
`Abilify*
`Immunoscience
`Orencia
`Cardiovascular
`Eliquis
`
`
`
`--
`++
`2017
`++
`
`++
`++
`2020
`++
`
`++
`
`++
`
`^
`
`Past or Currently Estimated Year of Basic Exclusivity Loss
`Total Revenues by Product
`EU(a)
`U.S.
`Japan
`China
`2014
`2013
`2012
` 
` 
` 
`                                 
`2014 (c) 
`  $ 1,441
`  $ 1,527
`2011-2016   
`2016   
`1,388
`++    
`2027    
`2027    
`256
`—
`—
`2017-2019 (d) 
`1,362
`1,551
`1,521
`2017   
`2019   
`2017 (e) 
`2013 (f) 
`1,444
`1,614
`1,527
`++   
`                                 
`2016 (g) 
`2016 (h) 
`++   
`723
`696
`702
`2027    
`++    
`2026    
`6
`—
`—
`2020    
`1,493
`1,280
`1,019
`2020  
`2021   
`2023 (h) 
`2021 (h) 
`1,308
`960
`706
`++   
`                                 
`2015 (i) 
`2014 (j) 
`++   
`2,020
`2,289
`2,827
`                                 
`2017 (h) 
`2018 (h) 
`2019   
`1,652
`1,444
`1,176
`                                 
`2023   
`2022   
`2022   
`774
`146
`2
`
`
`Note: The currently estimated earliest year of basic exclusivity loss includes any statutory extensions of exclusivity that have been granted. In some instances, we may
`be able to obtain an additional six months exclusivity for a product based on the pediatric extension. In certain other instances, there may be later-expiring patents that
`cover particular forms or compositions of the drug, as well as methods of manufacturing or methods of using the drug. Such patents may sometimes result in a favorable
`market position for our products, but product exclusivity cannot be predicted or assured. Under the U.S. healthcare law enacted in 2010, qualifying biologic products will
`receive 12 years of data exclusivity before a biosimilar can enter the market, as described in more detail in “—Intellectual Property and Product Exclusivity” below.
`
`
`
`*    Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index.
`++    We do not currently market the product in the country or region indicated.
`
`--    There is uncertainty about China
`’s exclusivity laws which has resulted in generic competition in the China market.
`^    There is uncertainty about China's exclusivity laws.
`
`(a) References to the EU throughout this Form 10-K include all member states of the European Union during the year ended December 31, 2014. Basic patent
`applications have not been filed in all current member states for all of the listed products. In some instances, the date of basic exclusivity loss will be different in
`various EU member states. For those EU countries where the basic patent was not obtained, there may be data protection available.
`(b) Exclusivity period relates to the Daklinza (daclatasvir) brand.
`(c)
`In September 2014, Teva Pharmaceuticals launched a generic version of Baraclude (entecavir). These actions follow a decision in June 2014 by the U.S. Court of
`Appeals for the Federal Circuit to uphold a lower court decision invalidating Baraclude’s patent in February 2013. A petition for a rehearing en banc was also
`denied in October 2014. The Company filed a petition for writ of certiorari with the U.S. Supreme Court in January 2015.
`(d) Data exclusivity in the EU expired in 2014 and market exclusivity expires between 2017 and 2019.
`(e) Exclusivity period relates to the Sustiva (efavirenz) brand and does not include exclusivity related to any combination therapy. The composition of matter patent
`for efavirenz in the U.S. expired in 2013 and the method of use patent for the treatment of HIV infection expired in September 2014. Pediatric exclusivity has
`been granted, which provides an additional six month period of exclusivity added to the term of the patents listed in the Orange Book. In October 2014, the
`Company announced that it has successfully resolved all outstanding U.S. patent litigation relating to efavirenz and that loss of exclusivity in the U.S. for efavirenz
`is not expected to occur until December 2017.
`(f) Exclusivity period relates to the Sustiva brand and does not include exclusivity related to any combination therapy. Market exclusivity for Sustiva expired in
`November 2013 in countries in the EU. Data exclusivity for Sustiva expired in the EU in 2009.
`(g) Biologic product approved under a Biologics License Application (BLA). Data exclusivity in the U.S. expires in 2016. There is no patent that specifically claims
`the composition of matter of cetuximab, the active ingredient in Erbitux*. Our rights to commercialize cetuximab terminate in 2018.
`(h) Exclusivity period is based on regulatory data protection.
`(i)
`In addition to anticipated loss of exclusivity, our U.S. commercialization rights of Abilify* (aripiprazole) terminate on April 20, 2015.
`(j) Our EU commercialization rights of Abilify* in the EU terminated in June 2014.
`
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`Page 3
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`Below is a summary of the indication, intellectual property position, product partner, if any, and third-party manufacturing arrangements, if any, for
`each of the above products in the U.S. and, where applicable, the EU and Japan.
`
`Baraclude
`
`Baraclude (entecavir) is a potent and selective inhibitor of hepatitis B virus that was approved by the U.S. Food and Drug
`Administration (FDA) for the treatment of chronic hepatitis B virus infection. Baraclude was discovered and developed
`internally.
`
`In September 2014, Teva Pharmaceuticals launched a generic version of Baraclude (entecavir) and we have
`experienced a rapid and significant negative impact on U.S. net product sales of Baraclude beginning in the fourth quarter
`of 2014. These actions follow a decision in June by the U.S. Court of Appeals for the Federal Circuit to uphold a lower
`court decision invalidating Baraclude’s patent in February 2013. A petition for rehearing en banc was also denied in
`October 2014. The Company filed a petition for writ of certiorari requesting U.S. Supreme Court review in January 2015. For
`more information about this patent litigation matter, see “Item 8. Financial Statements—Note 22. Legal Proceedings and
`Contingencies."
`
`The composition of matter patent expires in the EU between 2011 and 2016 and in Japan in 2016. There is
`uncertainty about China’s exclusivity laws which has resulted in generic competition in the China market.
`
`Bulk active entecavir is manufactured by both the company and a third party. The product is then finished in our
`facilities.
`
`Hepatitis C Franchise Daklinza (Daclatasvir (DCV)) is an oral small molecule NS5A replication complex inhibitor for the treatment of hepatitis C
`virus infection (HCV) and was approved in combination with other medicinal products in the EU across multiple genotypes
`in August 2014. The dual regimen with Sunvepra was also approved in Japan in July 2014. It is currently in the
`registrational process in the U.S. We own a patent covering daclatasvir as a composition of matter that expires in 2028 in
`the U.S.
`
`
`Reyataz Franchise
`
`Sustiva Franchise
`
`Sunvepra (Asunaprevir (ASV)) is an oral small molecule NS3 protease inhibitor for the treatment of HCV, and was
`approved as a dual regimen of DCV+ASV in Japan in July 2014. In October 2014, we announced that we would not pursue
`FDA approval of the dual regimen and we have withdrawn our New Drug Application (NDA)for asunaprevir.
`
`We manufacture our bulk requirements of daclatasvir and finish the product in our facilities. We obtain bulk
`requirements for asunaprevir from a third-party manufacturer and finish the product at a third-party facility.
`
`Reyataz (atazanavir sulfate) is a protease inhibitor for the treatment of HIV. The Reyataz Franchise includes Reyataz and
`combination therapy Evotaz (atazanavir 300 mg and cobicistat 150 mg) , a once-daily single tablet two drug regimen
`combining Reyataz and Gilead Sciences, Inc.'s (Gilead) Tybost* (cobicistat) for the treatment of HIV-1 infection in adults.
`
`We developed atazanavir under a worldwide license from Novartis Pharmaceutical Corporation (Novartis) for
`which a royalty is paid based on a percentage of net product sales. We are entitled to promote Reyataz for use in
`combination with Norvir* (ritonavir) under a non-exclusive license agreement with AbbVie Inc. (AbbVie), as amended, for
`which a royalty is paid based on a percentage of net product sales. We have a licensing agreement with Gilead for Evotaz,
`which was approved in January 2015.
`
`Market exclusivity for Reyataz is expected to expire in 2017 in the U.S. and China and 2019 in the major EU member
`countries and Japan. Data exclusivity in the EU expired in 2014.
`
`We manufacture our bulk requirements for atazanavir and finish the product in our facilities.
`
`Sustiva (efavirenz) is a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. The Sustiva Franchise
`includes Sustiva, an antiretroviral drug used in the treatment of HIV, as well as bulk efavirenz which is included in the
`combination therapy Atripla* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily
`single tablet three-drug regimen combining our Sustiva and Gilead’s Truvada* (emtricitabine and tenofovir disoproxil
`fumarate). For more information about our arrangement with Gilead, see “—Alliances” below and “Item 8. Financial
`Statements—Note 3. Alliances.”
`
`Rights to market efavirenz in the U.S., Canada, the UK, France, Germany, Ireland, Italy and Spain are licensed from
`Merck & Co., Inc. (Merck) for a royalty based on a percentage of revenues. Efavirenz is marketed by another company in
`Japan.
`
`
`
`4
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`Page 4
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`
`
`
`Erbitux*
`
`Opdivo
`
`Sprycel
`
`
`
`The composition of matter patent for efavirenz in the U.S. expired in 2013 and a method of use patent for the treatment of
`HIV infection expired in September 2014, with an additional six month period of pediatric exclusivity added to the term of
`these patents. In October 2014, the Company announced that it has successfully resolved all outstanding U.S. patent
`litigation relating to efavirenz and that loss of exclusivity in the U.S. for efavirenz is not expected to occur until December
`2017.
`
`Market exclusivity for Sustiva expired in November 2013 in countries in the EU. Data exclusivity for Sustiva
`expired in the EU in 2009.
`
`We obtain our bulk requirements for efavirenz from third parties and produce finished goods in our facilities. We
`supply our third parties’ bulk efavirenz to Gilead, who is responsible for producing the finished Atripla* product.
`
`Erbitux* (cetuximab) is an IgG1 monoclonal antibody designed to exclusively target and block the Epidermal Growth
`Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types as well as some
`normal cells. Erbitux*, a biological product, is approved in combination with irinotecan for the treatment of patients with
`EGFR-expressing metastatic colorectal cancer (mCRC) who have failed an irinotecan-based regimen and as monotherapy
`for patients who are intolerant of irinotecan. The FDA approved Erbitux* for use in combination with radiation therapy, for
`the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck and, as a single agent, for
`the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior
`platinum-based therapy has failed. The FDA also approved Erbitux* for first-line recurrent locoregional or metastatic head
`and neck cancer in combination with platinum-based chemotherapy with 5-Fluorouracil.
`
`Exclusive distribution rights in North America for cetuxmab were granted to the Company by ImClone Systems
`Incorporated (ImClone), the predecessor company of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company
`(Lilly) and is part of our alliance with Lilly. For more information about our alliance with Lilly, see “—Alliances” below and
`“Item 8. Financial Statements—Note 3. Alliances”
`
`Data exclusivity for Erbitux* in the U.S. expires in 2016. There is no patent that specifically claims the
`composition of matter of cetuximab, the active molecule in Erbitux*. Erbitux* has been approved by the FDA and other
`health authorities for monotherapy, for which there is no use patent. The use of Erbitux* in combination with 5-
`Fluorouracil (an anti-neoplastic agent) is approved by the FDA. Such combination use is claimed in a granted U.S. patent
`that expires in 2018 (including the granted patent term extension). This use patent was challenged by Yeda Research and
`Development Company Ltd. (Yeda). Pursuant to a December 2007 worldwide settlement agreement, Sanofi and Yeda
`granted ImClone a non-exclusive worldwide license under the use patent. Data exclusivity in Japan expires in 2016.
`
`Yeda has the right to license the use patent to third parties and has granted Amgen, Inc. (Amgen) a license.
`Amgen received FDA approval to market an EGFR-product that competes with Erbitux*. Yeda’s license of the patent to
`third parties could result in product competition for Erbitux* that might not otherwise occur and we are unable to assess
`the potential impact of such competition.
`
`We obtain our finished goods requirements for cetuximab for use in North America from Lilly. Lilly manufactures
`bulk requirements for cetuximab in its own facilities and filling and finishing is performed by a third party for which BMS
`has oversight responsibility. For a description of our supply agreement with Lilly, see “—Manufacturing and Quality
`Assurance” below.
`
`Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T and
`NKT cells. It is being investigated as an anticancer treatment. It is in Phase III trials (which commenced in 2012) in non-
`small cell lung cancer, renal cell cancer and melanoma. We jointly own a patent with Ono Pharmaceutical Co., LTD. (Ono)
`covering Opdivo as a composition of matter that expires in 2027 in the U.S. (excluding potential patent term extension). In
`December 2014, the FDA approved Opdivo for unresectable (inoperable) or metastatic melanoma, and disease progression
`following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo was also approved in Japan in July 2014
`for the same indication. The FDA has granted Fast Track designation for Opdivo in three tumor types: non-small cell lung
`cancer, renal cell carcinoma and metastatic melanoma, and it is in the registrational process for melanoma and non-small cell
`lung cancer in the U.S. and Europe. The FDA granted Breakthrough Therapy designation for Hodgkin Lymphoma in 2014.
`
`We obtain our bulk requirements for Opdivo from a third party and finish the product in our facilities.
`
`Sprycel (dasatinib) is a multi-targeted tyrosine kinase inhibitor approved for the first-line treatment of adults with
`Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and the treatment of adults with chronic,
`accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy,
`including Gleevec* (imatinib mesylate). Gleevec* is a trademark of Novartis.
`
`5
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`Page 5
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`
`
`
`Yervoy
`
`Sprycel was internally discovered and is part of our alliance with Otsuka. For more information about our alliance
`with Otsuka Pharmaceutical Co., Ltd. (Otsuka), see “—Alliances” below and “Item 8. Financial Statements—Note 3.
`Alliances”
`
`A patent term extension has been granted in the U.S. extending the term on the basic composition of matter patent
`covering dasatinib until June 2020. In 2013, the Company entered into a settlement agreement with Apotex regarding a
`patent infringement suit covering the monohydrate form of dasatinib whereby Apotex can launch its generic dasatinib
`monohydrate abbreviated New Drug Application (aNDA) product in September 2024, or earlier in certain circumstances. In
`the U.S., orphan drug exclusivity expired in 2013, which protected the product from generic applications for the currently
`approved orphan indications only.
`
`In the majority of the EU countries, we have a composition of matter patent covering dasatinib that expires in
`April 2020 (excluding potential term extensions). The composition of matter patent expires in 2021 in Japan and in 2020 in
`China.
`
`We manufacture our bulk requirements for dasatinib and finish the product in our facilities.
`
`Yervoy (ipilimumab), a biological product, is a monoclonal antibody for the treatment of patients with unresectable or
`metastatic melanoma. Yervoy was approved in the U.S. in March 2011 and in the EU in July 2011. It is currently also being
`studied for other indications including lung cancer as well as adjuvant melanoma and hormone-refractory prostate cancer.
`For more information, about research and development of Yervoy, see “—Research and Development” below.
`
`Yervoy was discovered by Medarex and co-developed by the Company and Medarex, which is now our
`subsidiary. We own a patent covering ipilimumab as a composition of matter that currently expires in 2022 in the U.S. and
`2020 in the EU (excluding potential patent term extensions). Data exclusivity expires in 2023 in the U.S. and 2021 in the EU.
`
`Bulk ipilimumab is manufactured by both the Company and a third party. The product is finished both in our
`facilities and at a third-party facility.
`
`Abilify*
`
`Abilify* (aripiprazole) is an atypical antipsychotic agent for adult patients with schizophrenia, bipolar mania disorder and
`major depressive disorder. Abilify* also has pediatric uses in schizophrenia and bipolar disorder, among others.
`
`We have a global commercialization agreement with Otsuka, excluding Japan, China and certain other Asian
`countries. For more information about our arrangement with Otsuka, see “—Alliances” below and “Item 8. Financial
`Statements—Note 3. Alliances.”
`
`The basic U.S. composition of matter patent covering aripiprazole and the term of the current Abilify* agreement
`expires on April 20, 2015 (including the granted patent term extension and six month pediatric extension).
`
`A composition of matter patent is in force in major EU countries. The original expiration date of 2009 had been
`extended to 2014 by grant of a supplementary protection certificate in most EU countries. Data exclusivity and the rights to
`commercialize in the EU expired in June 2014.
`
`We obtain our bulk requirements for aripiprazole from Otsuka. Both the Company and Otsuka finish the product in
`their own facilities.
`
`Orencia (abatacept), a biological product, is a fusion protein with novel immunosuppressive activity targeted initially at
`adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to certain
`currently available treatments. Orencia is available in both an intravenous and subcutaneous formulation in the U.S.,
`Europe and Japan.
`We have a series of patents covering abatacept and its method of use. In the U.S., a patent term extension has
`been granted for one of the composition of matter patents, extending the term of the U.S. patent to 2019. In the EU, the
`composition of matter patent covering abatacept expired in 2012. In the majority of the EU countries, we have applied for
`supplementary protection certificates and also pediatric extension of the supplementary protection certificates for
`protection until 2017. Most of these protection certificates have been granted. Data exclusivity expires in 2017 in the U.S.
`and the EU and 2018 in Japan.
`Bulk abatacept is manufactured by both the Company and a third party. We finish both formulations of the
`product in our own facilities.
`See "—Alliances" below for further discussion of our collaborations with Ono for Orencia in Japan.
`
`6
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`Orencia
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`Page 6
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`
`Eliquis
`
`Eliquis (apixaban) is an oral Factor Xa inhibitor targeted at stroke prevention in atrial fibrillation and the prevention and
`treatment of venous thromboembolic (VTE) disorders. Apixaban was discovered internally and is part of our alliance with
`Pfizer, Inc. (Pfizer). For more information about our alliance with Pfizer, see “Item 8. Financial Statements—Note 3.
`Alliances.”
`The composition of matter patent covering apixaban in the U.S. expires in February 2023 (excluding potential
`patent term extensions) and in the EU expires in 2022. We have applied for supplementary protection certificates. Some of
`these supplementary protection certificates have been granted and expire in 2026. Data exclusivity in the EU expires in
`2021.
`
`Apixaban is manufactured by both the Company and a third party. The product is then finished in our facilities.
`
`
`Research and Development
`
`We invest heavily in research and development (R&D) because we believe it is critical to our long-term competitiveness. We have major R&D
`facilities in New Jersey and Connecticut. Research and development is also carried out at various other facilities throughout the world, including in
`Belgium, the UK, India and other sites in the U.S. We supplement our internal drug discovery and development programs with alliances and
`collaborative agreements which help us bring new products into the pipeline. In drug development, we engage the services of physicians,
`hospitals, medical schools and other research organizations worldwide to conduct clinical trials to establish the safety and effectiveness of new
`products. Management continues to emphasize leadership, innovation, productivity and quality as strategies for success in our research and
`development activities.
`
`We concentrate our research and development efforts in the following disease areas with significant unmet medical needs: immuno-oncology,
`oncology, immunoscience, cardiovascular, virology, fibrotic diseases and genetically defined diseases. We also continue to analyze and may
`selectively pursue promising leads in other areas. In addition to discovering and developing new molecular entities, we look for ways to expand
`the value of existing products through new indications and formulations that can provide additional benefits to patients.
`
`In order for a new drug to reach the market, industry practice and government regulations in the U.S., the EU and most foreign countries provide
`for the determination of a drug’s effectiveness a