MYLAN INC.
`
`FORM 10-K
`
`(Annual Report)
`
`Filed 03/02/15 for the Period Ending 12/31/14
`
`
`Address
`
`
`1000 MYLAN BOULEVARD
`CANONSBURG, PA 15317
`724-514-1800
`Telephone
`0000069499
`CIK
`Symbol MYL
`SIC Code
`2834 - Pharmaceutical Preparations
`Industry
`Biotechnology & Drugs
`Sector Healthcare
`Fiscal Year
`12/31
`
`http://www.edgar-online.com
`© Copyright 2015, EDGAR Online, Inc. All Rights Reserved.
`Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
`
`NCI Exhibit 2004
`Page 1 of 156
`
`

`

`
`
`
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, DC 20549
`FORM 10-K
`
`(cid:1)
`
`
`Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
`For the Fiscal Year Ended December 31, 2014
`
`OR
`
`
`
`
`Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
`For the transition period from to .
`
`Commission file number 1-9114
`
`MYLAN INC.
`
`(Exact name of registrant as specified in its charter)
`
`25-1211621
`Pennsylvania
`
`(State or other jurisdiction of incorporation or organization)
`
`(I.R.S. Employer Identification No.)
`1000 Mylan Boulevard, Canonsburg, Pennsylvania 15317
`(Address of principal executive offices)
`(724) 514-1800
`(Registrant’s telephone number, including area code)
`Securities registered pursuant to Section 12(b) of the Act:
`
`
`
`
`Name of Each Exchange on Which Registered:
`The NASDAQ Stock Market
`
`Title of Each Class:
`Common Stock, par value $0.50 per share
`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 (cid:1) 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 (cid:1)
`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 (cid:1) 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 (cid:1) 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 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. (cid:1)
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the
`definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.:
`
`Large accelerated filer
`
`Non-accelerated filer
`
`(cid:1)
`
`
`
`(Do not check if a smaller reporting company)
`
` Accelerated filer
`
`
`
` 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 (cid:1)
`The aggregate market value of the outstanding common stock, other than shares held by persons who may be deemed affiliates of the registrant, as of June 30,
`2014 , the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $19,152,056,870 .
`The number of shares outstanding of common stock of the registrant as of February 24, 2015 was 378,373,668 .
`
`INCORPORATED BY REFERENCE
`
`Document
`An amendment to this Form 10-K will be filed no later than 120 days after the close of registrant’s fiscal year.
`
`Part of Form 10-K into Which
`Document is Incorporated
`III
`
`
`
`
`
`
`
`
`
`
`EXPLANATORY NOTE
`
`As discussed herein, on February 27, 2015 (the “Closing Date”), Mylan N.V. completed the transaction by which it acquired Mylan Inc. and
`
`NCI Exhibit 2004
`Page 2 of 156
`
`

`

`Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business. Pursuant to the terms of the Amended and
`Restated Business Transfer Agreement and Plan of Merger, dated as of November 4, 2014, by and among Mylan Inc., New Moon B.V. (which
`has been renamed Mylan N.V.), Moon of PA Inc., and Abbott Laboratories, on the Closing Date, Mylan N.V. acquired Abbott Laboratories’
`non-U.S. developed markets specialty and branded generics business and Moon of PA Inc. merged with and into Mylan Inc., with Mylan Inc.
`surviving as a wholly owned indirect subsidiary of Mylan N.V. (the “Merger”) and each share of Mylan Inc. common stock issued and
`outstanding was canceled and automatically converted into and became the right to receive one Mylan N.V. ordinary share. In connection with
`this transaction, Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business were reorganized
`under Mylan N.V., a new public company organized in the Netherlands. On February 18, 2015, the Office of Chief Counsel of the Division of
`Corporation Finance of the Securities and Exchange Commission issued a no-action letter to Mylan Inc. and Mylan N.V. that included its views
`that the Merger constituted a “succession” for purposes of Rule 12g-3(a) under the Securities and Exchange Act of 1934, as amended (the
`“Exchange Act”), and that Mylan N.V., as successor to Mylan Inc., is deemed a large accelerated filer for purposes of Exchange Act Rule 12b-2.
`Mylan Inc. is filing this Annual Report on Form 10-K in accordance with Rule 12g-3(g) of the Exchange Act. As of March 2, 2015, Mylan N.V.,
`and not Mylan Inc., traded on the NASDAQ Stock Market under the symbol “MYL”.
`
`
`
`
`NCI Exhibit 2004
`Page 3 of 156
`
`

`

`
`
`
`
`
`
`
`ITEM 1.
`ITEM 1A.
`ITEM 1B.
`ITEM 2.
`ITEM 3.
`
`
`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.
`
`
`ITEM 15.
`Signatures
`
`
`MYLAN INC.
`INDEX TO FORM 10-K
`For the Year Ended December 31, 2014
`
`PART I
`
`
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`
`
`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 Accounting Fees and Services
`
`
`PART IV
`Exhibits and Consolidated Financial Statement Schedules
`
`2
`
`
`
`
`
`
`
`
`
`
`
`
`Page
`
`3
`24
`47
`47
`47
`
`48
`50
`52
`76
`78
`130
`130
`131
`
`132
`132
`132
`132
`132
`
`133
`142
`
`NCI Exhibit 2004
`Page 4 of 156
`
`

`

`
`
`
`
`ITEM 1. Business
`
`
`PART I
`
`Unless otherwise indicated, the following discussion relates to Mylan Inc. prior to the consummation of the Transaction, defined below, on
`February 27, 2015 .
`
`Mylan Inc. , along with its subsidiaries (collectively, the “Company,” “ Mylan ,” “our” or “we”), is a leading global pharmaceutical company,
`which develops, licenses, manufactures, markets and distributes generic, branded generic and specialty pharmaceuticals. Mylan is committed to setting
`new standards in health care and our mission is to provide the world’s 7 billion people access to high quality medicine. To do so, we innovate to satisfy
`unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership.
`
`Mylan offers one of the industry’s broadest product portfolios, including approximately 1,400 marketed products, to customers in
`approximately 140 countries and territories. With the completion of the Abbott Laboratories (“ Abbott ”) transaction discussed below, Mylan has
`expanded its global footprint to reach customers in approximately 145 countries and territories. We operate a global, high quality vertically-integrated
`manufacturing platform, which includes approximately 40 manufacturing facilities around the world and one of the world’s largest active
`pharmaceutical ingredient (“API”) operations. We also operate a strong research and development (“R&D”) network that has consistently delivered a
`robust product pipeline. Additionally, Mylan has a specialty business that is focused on respiratory and allergy therapies.
`
`Overview
`
`Throughout its history, Mylan has been recognized as a leader in the United States (“U.S.”) generic pharmaceutical industry. Our leadership
`position is the result of, among other factors, our ability to efficiently obtain Abbreviated New Drug Application (“ANDA”) approvals and our reliable
`high quality supply chain.
`
`Through organic growth and transformative acquisitions since 2007, Mylan is one of the largest generic and specialty pharmaceuticals
`companies in the world today in terms of revenue and is now recognized as an industry leader globally.
`
`
`On July 13, 2014 , the Company entered into a definitive agreement with Abbott to acquire Abbott’s non-U.S. developed markets specialty and
`branded generics business (the “Business”) in an all-stock transaction. On November 4, 2014 , the Company and Abbott entered into an amended and
`restated definitive agreement implementing the transaction (the “Transaction Agreement”). The transaction, defined below, closed on February 27, 2015
`after receiving approval from Mylan’s shareholders on January 29, 2015 . At closing, Abbott transferred the Business to Mylan N.V. , (“ New Mylan ”)
`in exchange for 110 million ordinary shares of New Mylan . Immediately following the transfer of the Business, Mylan merged with a wholly owned
`subsidiary of New Mylan (together with the transfer of the Business, the “Transaction”), with Mylan becoming a wholly owned indirect subsidiary of
`New Mylan . Mylan ’s outstanding common stock was exchanged on a one to one basis for New Mylan ordinary shares. As a result of the Transaction,
`New Mylan ’s corporate seat is located in Amsterdam, the Netherlands , and its principal executive offices are located in Potters Bar, United Kingdom .
`New Mylan will also have global centers of excellence in the U.S., Europe and India.
`
`
`The Business includes more than 100 specialty and branded generic pharmaceutical products in five major therapeutic areas and includes
`several patent protected, novel and/or hard-to-manufacture products. As a result of the acquisition, Mylan N.V. has significantly expanded and
`strengthened its product portfolio in Europe, Japan, Canada, Australia and New Zealand.
`
`The purchase price of the Transaction, which was on a debt-free basis, was $6.31 billion based on the closing price of Mylan stock as of the
`Transaction closing date, as reported by the NASDAQ Stock Market . As a result of the Transaction, Mylan shareholders own approximately 78% of
`New Mylan and Abbott ’s affiliates own approximately 22% of New Mylan . New Mylan and Abbott entered into a shareholder agreement in connection
`with the Transaction.
`
`Through this Transaction, along with previous transformative acquisitions of Agila Specialties (‘‘ Agila ’’), Mylan Laboratories Limited (“
`Mylan India ”), Merck KGaA’s generics and specialty pharmaceutical business, Bioniche Pharma Holdings Limited (“ Bioniche Pharma ”) and Pfizer
`Inc.’s respiratory delivery platform (the “respiratory delivery platform”), we have created a horizontally and vertically integrated platform with global
`scale, augmenting our diversified product portfolio and further expanding our range of capabilities, all of which we believe position us well for the
`future.
`
`
`
`3
`
`NCI Exhibit 2004
`Page 5 of 156
`
`

`

`
`
`
`Today, in addition to the U.S., Mylan has a robust worldwide commercial presence in the generic pharmaceutical market, including leadership
`positions in France and Australia and several other key European markets as well as markets around the world. Mylan is also a leader in branded
`specialty pharmaceuticals focusing on respiratory and allergy products.
`
`Currently, Mylan markets a global portfolio of approximately 1,400 different products covering a vast array of therapeutic categories. We offer
`an extensive range of dosage forms and delivery systems, including oral solids, topicals, liquids and semi-solids while focusing on those products that
`are difficult to formulate and manufacture, and typically have longer life cycles than traditional generic pharmaceuticals, including transdermal patches,
`high potency formulations, injectables, controlled-release and respiratory products. In addition, we offer a wide range of antiretroviral therapies
`(“ARVs”), upon which approximately 40% of HIV/AIDS patients in developing countries depend. Mylan also operates one of the largest API
`manufacturers, supplying low cost, high quality API for our own products and pipeline as well as for a number of third parties.
`
`
`We believe that the breadth and depth of our business and platform provide certain competitive advantages in major markets in which we
`operate, including less dependency on any single market or product. As a result, we are better able to successfully compete on a global basis than
`compared to many of our competitors.
`
`Our Operations
`
`Mylan was incorporated in Pennsylvania in 1970 and maintains its principal executive offices in Canonsburg, Pennsylvania . Mylan operates in
`two segments, “Generics” and “Specialty.” Our revenues are derived primarily from the sale of generic and branded generic pharmaceuticals, specialty
`pharmaceuticals and API. Our generic pharmaceutical business is conducted primarily in the U.S. and Canada (collectively, “North America”); Europe;
`and India, Australia, Japan, New Zealand and Brazil as well as our export activity into emerging markets (collectively, “Rest of World”). Our API
`business is conducted through Mylan India , which is included within Rest of World in our Generics segment. Our specialty pharmaceutical business is
`conducted by Mylan Specialty L.P. (“ Mylan Specialty ”). Refer to Note 12 for Consolidated Financial Statements included in Item 8 in this Form 10-K
`for additional information related to our segments, including our geographic markets.
`
`Our global operational footprint, including the locations of our manufacturing facilities, global R&D centers of excellence and technology
`focused development sites, along with the sites’ primary activities, are detailed on the map below:
`
`
`
`Our global manufacturing platform is an important component of our business model. We own six production, distribution and warehousing
`facilities in the U.S. and Puerto Rico, including significant production and distribution sites in Morgantown, West Virginia; St. Albans, Vermont;
`Caguas, Puerto Rico; and Greensboro, North Carolina. Outside the U.S. and Puerto Rico, we own production, distribution and warehousing facilities in
`nine countries, including key facilities in India, Australia, Japan, Ireland, Brazil, Hungary, Poland and France. In addition, as a result of the Transaction,
`the Company acquired two high-quality manufacturing facilities in Chatillon, France and Katsuyama, Japan.
`
`
`4
`
`NCI Exhibit 2004
`Page 6 of 156
`
`

`

`
`
`
`
`The Company also leases warehousing, distribution and administrative facilities in numerous locations, within and outside of the U.S.,
`including properties in New York, France, India, Ireland and the United Kingdom (“U.K.”). All of the production, distribution and warehousing
`facilities are included within the Generics segment; however, certain locations also support our Specialty segment.
`
`Our global R&D centers of excellence are located in Morgantown, West Virginia and Hyderabad, India. We also have specific R&D
`technology centers of excellence in Ireland, India, the U.K. and Japan. As a result of the Transaction, New Mylan ’s corporate seat is located in
`Amsterdam, the Netherlands , and its principal executive offices are located in Potters Bar, United Kingdom . New Mylan will also have global centers
`of excellence in the U.S., Europe and India.
`
`We believe that all of our facilities are in good operating condition, the machinery and equipment are well-maintained, the facilities are suitable
`for their intended purposes and they have capacities adequate for the current operations.
`
`Generics Segment
`
`North America
`
`The U.S. generics market is the largest in the world, with generic prescription sales of $55.6 billion for the twelve months ended November
`2014 . Mylan holds the number one ranking in the U.S. generics prescription market in terms of sales and the number two ranking in terms of
`prescriptions dispensed. Approximately one in every 13 prescriptions dispensed in the U.S. is a Mylan product. Our sales in the U.S. are derived
`primarily from the sale of oral solid dosage, injectable and transdermal products and unit dose offerings. In the U.S., we have one of the largest product
`portfolios among all generic pharmaceutical companies, consisting of approximately 360 products, of which approximately 270 are in capsule or tablet
`form, in an aggregate of approximately 815 dosage strengths. Included in these totals are approximately 45 extended-release products in a total of
`approximately 105 dosage strengths.
`
`We manufacture and sell a diverse portfolio of injectable products across several key therapeutic areas, including antineoplastics, anti-
`infectives, anesthesia/pain management and cardiovascular. Our product offerings include a diverse portfolio of approximately 125 injectable products
`(branded and generic) in a total of approximately 175 dosage strengths. As of December 31, 2014 , approximately 120 injectable products have been
`filed and are pending ANDA approval for the U.S. market. Mylan’s injectable manufacturing capabilities include vials, pre-filled syringes, ampoules
`and lyophilization with a focus on antineoplastics, penems, penicillins, ophthalmics and peptides.
`
`Our unit dose business focuses on providing one of the largest product portfolios along with innovative packaging and barcoding that supports
`bedside verification throughout the U.S. and Canada for hospitals, group purchasing organizations (“GPOs”), long term care facilities, wholesalers,
`surgical services, home infusion service providers, correctional facilities, specialty pharmacies and retail outlets. In addition to the products we package
`in the U.S., we also market approximately 60 generic products in a total of approximately 80 dosage strengths under supply and distribution agreements
`with wholesalers. Also included in our U.S. product portfolio are five transdermal patch products in a total of 25 dosage strengths, including our
`Fentanyl Transdermal System (“Fentanyl”) which was the first AB-rated generic alternative to Duragesic® on the market and was also the first generic
`class II narcotic transdermal product ever approved.
`
`We believe that the breadth and quality of our product offerings help us to successfully meet our customers’ needs and to better compete in the
`generic industry over the long-term. The future growth of our U.S. generics business is partially dependent upon continued acceptance of generic
`products as affordable alternatives to branded pharmaceuticals, a trend which is largely outside of our control. However, we believe that we can
`maximize the profitability of our generic product opportunities by continuing our proven track record of bringing to market high quality products that
`are difficult to formulate or manufacture. Over the last several years we have successfully introduced many generic products that are difficult to
`formulate or manufacture and continue to be meaningful contributors to our business several years after their initial launch. Additionally, we expect to
`achieve growth in our U.S. business by launching new products for which we may attain U.S. Food and Drug Administration (“FDA”) first-to-file status
`with Paragraph IV certification. As described further in the “Product Development and Government Regulation” discussion below, Paragraph IV
`certification qualifies the product approval holder for a period of generic marketing and distribution exclusivity.
`
`In Canada, we offer a portfolio of approximately 170 products in an aggregate of approximately 375 dosage strengths and currently rank
`seventh in terms of market share in the generic prescription market. As in the U.S., growth in Canada will be dependent upon acceptance of generic
`products as affordable alternatives to branded pharmaceuticals. Further, we plan to
`
`
`5
`
`NCI Exhibit 2004
`Page 7 of 156
`
`

`

`
`
`leverage the strength and reliability of the Mylan brand to foster growth throughout the region. With the acquisition of Agila , we further diversified our
`pharmaceutical portfolio by adding generic injectable products in the Canadian market.
`
`
`Europe
`
`Our generic pharmaceutical sales in Europe are generated primarily by our wholly owned subsidiaries, through which we have operations in 22
`countries. The types of markets within Europe vary from country to country; however, when combined, the European market is the second largest
`generic pharmaceutical market in the world in terms of value. Within Europe, by value, the generic prescription market in Germany is the largest ,
`followed by the U.K., France, Spain and Italy, respectively. Of the top ten generic prescription markets in Europe, we hold leadership positions in
`several markets, described below, including the number one market share position in France, the number two market share position in Italy and the
`number three market share position in Portugal.
`
`The European generic prescription market varies significantly by country in terms of the extent of generic penetration, the key decision maker
`in terms of drug choice and other important aspects. Some countries, including Germany, the U.K., the Netherlands and Poland, are characterized by
`relatively high generic penetration, ranging between 66% and 72% of total prescription market sales in the twelve months ended November 2014 , based
`on volume. Conversely, other major European markets, including France, Italy and Spain, are characterized by much lower generic penetration, ranging
`between 19% and 40% of total prescription sales in the twelve months ended November 2014 , based on volume. However, recent actions taken by
`governments, particularly in these latter under-penetrated countries, to reduce health care costs could encourage further use of generic pharmaceutical
`products. In each of these under-penetrated markets, in addition to growth from new product launches, we expect our future growth to be driven by
`increased generic utilization and penetration.
`
`The manner in which products are marketed also varies by country. In addition to selling pharmaceuticals under their International
`Nonproprietary Name (“INN”) (i.e., API), in certain European countries, there is a market for both branded generic products and “company-branded”
`generic products. Branded generic pharmaceutical products are given a unique brand name, as these markets tend to be more responsive to the
`promotion efforts generally used to promote brand products. Company-branded products generally consist of the name of the active ingredient with a
`prefix or suffix of the company’s name, either in whole or in part.
`
`France
`
`In France, we market a portfolio, including both oral solid and injectable dosage forms, of approximately 300 products in an aggregate of
`approximately 670 dosage strengths. We have the highest market share in the generic market, with a share of approximately 26% . Our future growth in
`the French market is expected to come primarily from new product launches and increased generic utilization and penetration through government
`initiatives.
`
`
`Italy
`
`In Italy, we market a portfolio of approximately 170 products in an aggregate of approximately 340 dosage strengths. We have the second
`highest market share in the company-branded generic prescription market, with a share of approximately 19% . We believe that the Italian generic
`market is under-penetrated, with company-branded generics representing approximately 20% of the Italian pharmaceutical market, based on volume.
`The Italian government has put forth only limited measures aimed at encouraging generic use, and as a result, generic substitution is still in its early
`stages. Our growth in the Italian generics market will be fueled by increasing generic utilization and penetration and new product launches.
`
`United Kingdom
`
`In the U.K., we market a portfolio of approximately 185 products in an aggregate of approximately 350 dosage strengths. Mylan is ranked
`fourth in the U.K. generic prescription market, in terms of value, with an estimated market share of approximately 6% . Mylan is well positioned in the
`U.K. as a preferred supplier to wholesalers and is also focused on areas such as multiple retail pharmacies and hospitals. The U.K. generic prescription
`market is highly competitive, and any growth in the market will stem from new product launches although we expect that the value will continue to be
`affected by price erosion.
`
`
`Spain
`
`In Spain, we market a portfolio of approximately 135 products in an aggregate of approximately 290 dosage strengths. We have the seventh
`highest market share in the company-branded generic prescription market. The company-branded generic market comprised approximately 34% of the
`total Spanish pharmaceutical market by volume for the twelve months ended
`
`
`6
`
`NCI Exhibit 2004
`Page 8 of 156
`
`

`

`
`
`November 2014 . We view further generic utilization and penetration of the Spanish market to be a key driver of our growth in that country.
`
`The Netherlands
`
`In the Netherlands, we market a portfolio of approximately 230 products in an aggregate of approximately 480 dosage strengths. We have the
`fourth largest market share in the generic prescription market. The Netherlands is characterized by relatively high generic penetration representing
`approximately 67% of total prescription market sales in the twelve months ended November 2014 , based on volume.
`
`Germany
`
`In Germany, we market a portfolio of approximately 145 products in an aggregate of approximately 320 dosage strengths. A tender system has
`been implemented in Germany and, as a result, health insurers play a major role in this market. Under a tender system, health insurers invite
`manufacturers to submit bids that establish prices for generic pharmaceuticals. Pricing pressures result from an effort to win the tender. As a result of
`these tenders, our business in Germany has grown, and future growth in the German marketplace will depend upon our ability to compete based
`primarily on price.
`
`Poland
`
`As part of the acquisition of Agila , we acquired an injectable manufacturing facility in Poland. In addition, we also operate a commercial
`business in Poland focused on the generic prescription market. Our future growth is expected to come from increasing the production capacity of our
`injectable facility and through new product launches.
`
`Other European Locations
`
`We have a notable presence in other European generic prescription markets, including Portugal, where we hold the third highest market share
`in terms of value. We also operate in several other European markets, including Ireland, the Nordic countries (principally Sweden and Finland),
`Belgium, the Czech Republic and Hungary.
`
`Rest of World
`
`We market generic pharmaceuticals in Rest of World through subsidiaries in India, Australia, Japan, New Zealand, Brazil and Taiwan.
`Additionally, we have an export business which is focused on countries in Africa and emerging markets throughout the world. We also participate in a
`collaboration with Pfizer Japan Inc. (“Pfizer Japan”) to develop, manufacture, distribute and market generic drugs in Japan. Additionally, through Mylan
`India , we market API to third parties and also supply other Mylan subsidiaries. We have the highest market share in both the Australian and New
`Zealand generic pharmaceuticals markets.
`
`India
`
`Mylan India manufactures and supplies low cost, high quality API for our own products and pipeline, as well as for numerous third parties.
`Mylan India is one of the world's largest API manufacturers as measured by the number of drug master files (“DMFs”) filed with regulatory agencies.
`Mylan India also produces a line of finished dosage form (“FDF”) products for the ARV market, which are sold mostly outside of India. Additionally,
`Mylan India manufactures non-ARV FDF products that are marketed and sold to third parties by other Mylan operations around the world. Expansion of
`Mylan India ’s portfolio and an increase in product sales within India are both key drivers of our future growth.
`
`
`We currently have over 300 APIs in the market or under development and we focus our marketing efforts on regulated markets such as the
`U.S. and the European Union (the “EU”). We produce API for use in the manufacture of our own pharmaceutical products, as well as for use by third
`parties, in a wide range of categories, including anti-bacterials, central nervous system agents, anti-histamine/anti-asthmatics, cardiovasculars, anti-
`virals, anti-diabetics, anti-fungals, proton pump inhibitors and pain management drugs.
`
`Mylan India has nine API and intermediate manufacturing facilities, four FDF facilities and eight injectable facilities. All of these facilities are
`located in India. Eight of the API facilities, two FDF facilities and four injectable facilities have been successfully inspected by the FDA, which makes
`Mylan India one of the largest companies in India in terms of API manufacturing facilities that have passed FDA inspection. From an API standpoint,
`growth is dependent upon us continuing to
`
`
`7
`
`NCI Exhibit 2004
`Page 9 of 156
`
`

`

`
`
`leverage our R&D capabilities to produce high quality, low cost API, while capitalizing on the greater API volumes afforded through our vertically
`integrated platform.
`
`In August 2012, Mylan commenced commercial operations in India starting with the launch of a comprehensive portfolio of FDF ARV
`products for the treatment of HIV/AIDS. In June 2013, Mylan added a portfolio of women’s health care products focused on hormone and infertility
`treatments along with nutritional supplements. During December 2013, the portfolio was further enhanced by adding products from therapeutic
`categories such as oncology and critical care.
`
`Australia
`
`The generic pharmaceutical market in Australia had sales of approximately $1.9 billion during the twelve months ended November 2014 . Our
`Australian operation has the highest market share in the generic market with an estimated 31% market share by volume and we offer a portfolio of
`approximately 180 products in an aggregate of approximately 375 dosage strengths. The Australian generics market is still underdeveloped and, as a
`result, the government is increasingly focused on encouraging the use of generics in an effort to reduce costs. Maintaining our position of market
`leadership as the market undergoes further generic utilization and penetration and continued pricing pressure will be instrumental to our future success
`in Australia.
`
`Japan
`
`Beginning in 2013, we established an exclusive long-term strategic collaboration with Pfizer Japan to develop, manufacture, distribute and
`market generic drugs in Japan. Under the agreement, both parties operate separate legal entities in Ja