Long considered a leader in the United States (“U.S.”) generic pharmaceutical market, Mylan has grown into a worldwide pharmaceutical leader and is currently the third largest generic and specialty pharmaceutical company in the world, in terms of revenues. This evolution has taken place through organic growth and external expansion. Organically, we have attained a position of leadership in the U.S. generic pharmaceutical industry through our ability to obtain Abbreviated New Drug Application (“ANDA”) approvals and our reliable supply chain. Through the acquisition of Matrix Laboratories Limited (“Matrix”) and the acquisition of Merck KGaA’s generics and specialty pharmaceutical business (“the former Merck Generics business”), we have created a horizontally and vertically integrated platform with global scale, a diversified product portfolio and an expanded range of capabilities that position us well for the future. We believe that as a result of these acquisitions we are less dependent on any single market or product and are able to compete successfully on a global basis.
Through Matrix, an Indian subsidiary, we manufacture and supply low cost, high quality API for our own products and pipeline, as well as for third parties. Matrix is one of the world’s largest API manufacturers with respect to the number of drug master files (“DMFs”) filed with regulatory agencies. Matrix is also a leader in supplying API for the manufacturing of anti-retroviral (“ARV”) drugs, which are utilized in the treatment of HIV/AIDS. Additionally, Matrix offers a line of finished dosage form (“FDF”) products in both the ARV and non-ARV markets.
Matrix had been an Indian listed company in which Mylan owned a 71.2% controlling interest. During 2009, pursuant to the completion of a voluntary delisting offer, Mylan purchased additional shares of Matrix from its then minority shareholders, bringing both the Company’s total ownership and control to over 96%. Matrix’s stock was delisted from the Indian stock exchanges effective August 21, 2009.
The acquisition of the former Merck Generics business has provided Mylan a worldwide commercial footprint, including leadership positions in France and Australia and several other key European and Asia Pacific markets, as well as a leading branded specialty pharmaceutical business focusing on respiratory and allergy products.
Currently, Mylan markets more than 900 different products covering a vast array of therapeutic categories, to consumers in more than 140 countries and territories across the globe. We offer an extensive range of dosage forms and delivery systems, including oral solids, topicals, liquids and semi-solids, as well as some which are difficult to formulate and manufacture and typically have longer product life cycles than traditional generic pharmaceuticals, including high potency formulations, steriles, injectables, transdermal patches, controlled release and respiratory delivery products.
Mylan also has the deepest pipeline and largest number of products pending regulatory approval in the Company’s history. Mylan will benefit from substantial operational efficiencies and economies of scale from increased sales volumes and its vertically and horizontally integrated platform.
We believe that the breadth and depth of our business provides certain competitive advantages over many of our competitors in major markets. These advantages include global research and development and manufacturing facilities that provide for additional technologies, economies of scale and a broad product portfolio, as well as an API business, which ensures a high quality, stable supply.
Mylan previously had three reportable segments, “Generics”, “Specialty” and “Matrix.” The Matrix Segment had consisted of Matrix. Following the acquisition of approximately 25% of the remaining interest in Matrix and its related delisting from the Indian stock exchanges, Mylan now has two reportable segments, “Generics” and “Specialty.” Mylan changed its segments to align with how the business is being managed after those changes. The former Matrix Segment is included within the Generics Segment. Information for earlier periods has been recast. Refer to Note 17 to Consolidated Financial Statements included elsewhere in this Form 10-K for additional information related to our segments.
The U.S. generics market is the largest in the world, with revenues of $34.4 billion for the twelve months ended November 2009. Mylan holds the number two ranking in the U.S. generics market in terms of both revenue and prescriptions dispensed. Our sales are derived principally through Mylan Pharmaceuticals Inc. (“MPI”) and UDL Laboratories, Inc. (“UDL”), our wholly-owned subsidiaries. MPI is our primary U.S. pharmaceutical research, development, manufacturing, marketing and distribution subsidiary. MPI’s net revenues are derived primarily from the sale of solid oral dosage products. Additionally, MPI’s net revenues are augmented by transdermal patch products that are developed and manufactured by Mylan Technologies, Inc. (“MTI”), our wholly-owned transdermal technology subsidiary. UDL primarily re-packages and markets products either obtained from MPI or purchased from third parties, in unit dose formats, for use primarily in hospitals and other medical institutions.
Our generic pharmaceutical sales in EMEA are generated primarily by our wholly-owned subsidiaries in Europe. We have operations in 25 countries. Of the top ten generic retail pharmaceutical markets in Europe, we hold a number one market share position in France and Italy, we hold a top three market share position in the United Kingdom (“U.K.”), Belgium and Portugal, and we hold a top five market share position in Spain and the Netherlands.
We market generic pharmaceuticals in Asia Pacific through wholly-owned subsidiaries in Australia, New Zealand, India and Japan. Additionally, we market API to third parties as well as to other Mylan subsidiaries through our Indian subsidiary, Matrix. We hold the number one market positions in both Australia and New Zealand and the number four market position in Japan.
Our specialty pharmaceutical business is conducted through Dey, which competes primarily in the respiratory, severe allergy and psychiatry markets. Dey’s products are primarily branded specialty nebulized, injectable and transdermal products for life-threatening conditions. Since our acquisition of Dey, a significant portion of Dey’s revenues have been derived primarily through the sale of the EpiPen® auto-injector.
We currently employ more than 15,500 people globally, made up of approximately 12,500 permanent employees and approximately 3,000 temporary employees. The production and maintenance employees at our manufacturing facility in Morgantown, West Virginia, are represented by the United Steelworkers of America (USW) (AFL-CIO) and its Local Union 957 AFL-CIO under a contract that expires on April 15, 2012. In addition, there are non-U.S. Mylan locations, primarily concentrated in Europe and India, that have employees who are unionized or part of works councils or trade unions.