Headquarters: Petach Tivka, Israel
Year Established: 1901
Revenues: $21,903 (+11%)
Specialty Pharma Revenues: $8,674 (+4%)
Net Income: $311 (-81%)
R&D: $2,111 (+38%)
TOP SELLING DRUGS
Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis (MS) as well as late-stage development programs for other disorders of the central nervous system (CNS), including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products.
The Generic medicines segment includes chemical and therapeutic equivalents of originator medicines in a variety of dosage forms, such as tablets, capsules, injectables, inhalants, liquids, ointments and creams. Teva is the leading generic drug company in the U.S. and Europe. This segment includes the OTC business, conducted primarily through PGT, a consumer healthcare joint venture with P&G, as well as its active pharmaceutical ingredient (API) manufacturing business.
Specialty medicines includes Teva’s core therapeutic areas of CNS medicines such as Copaxone and Azilect and respiratory medicines such as ProAir and QVAR. The specialty medicines segment also includes products in other therapeutic areas, such as Bendeka/Treanda in oncology and ParaGard in women’s health.
Teva’s revenues in 2016 were $21.9 billion, up from $19.6 the year before. The Generics segment makes up 55% of sales, followed by the Specialty (39%) and Other (6%) segments. In geographic terms, the U.S. accounts for the bulk of sales with a 53% share, followed by Europe (25%) and ROW markets (22%).
Of note during the year, in August, Teva completed its acquisition of Allergan’s worldwide generic pharmaceuticals business, Actavis Generics. At closing, Teva paid Allergan roughly $33.4 billion. The acquisition significantly expanded its generics product portfolio and pipeline, and R&D capabilities.
As part of the Actavis acquisition, Teva divested certain products in the U.S. and Europe, to meet antitrust regulatory requirements. It sold its Actavis Generics assets and operations in the UK and Ireland to Accord Healthcare for approximately $768 million. The sale included a portfolio of generic medicines plus a manufacturing plant in Barnstaple, England.
During the year, Mayne Pharma completed its $652 million transaction with Teva and Allergan, gaining 37 approved and five filed generic pharmaceutical products. This transaction is among the largest generic pharmaceutical divestitures and followed Teva’s purchase of Allergan’s generic drug business.
Also, Impax Laboratories signed definitive agreements with Teva and affiliates of Allergan for the acquisition of a broad portfolio of generic products across solid oral, inhalable, injectable and topical dosage forms for $586 million. The deal also includes the return to Impax of its rights to its pending abbreviated new drug application (ANDA) for the generic equivalent to Concerta (methylphenidate hydrochloride).
In October 2016, Teva completed the acquisition of Anda Inc., the fourth largest distributor of generic pharmaceuticals in the U.S., from Allergan for $500 million.
During the year, Teva entered into a collaborative agreement with Regeneron Pharmaceuticals to develop and commercialize Regeneron’s pain medication product, fasinumab. It paid Regeneron $250 million upfront and will share the global commercial benefits of this product, as well as ongoing associated research and development costs of approximately $1 billion, equally with Regeneron. Following the termination of the Phase II clinical study for chronic low back pain in October 2016, Teva and Regeneron planned to design a Phase III study in chronic low back pain that excludes patients with advanced osteoarthritis.
Teva and Celltrion entered into an exclusive partnership to commercialize two of Celltrion’s mAb biosimilar candidates in the U.S. and Canada. CT-P10 is a proposed mAb biosimilar to Rituxan (rituximab), which is used to treat Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Wegener’s Granulomatosis and Microscopic Polyangiitis (MPA). CT-P6 is a proposed mAb biosimilar to Herceptin (trastuzumab), which is used to treat HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Rituxan and Herceptin have combined annual sales of approximately $6.5 billion in the U.S. and Canada. Teva will be responsible for all commercial activities in the U.S. and Canada, pending regulatory approvals. Celltrion has responsibility for completing all clinical development and regulatory activities. Celltrion receiveed $160 million upfront.
Teva also completed the acquisition of Representaciones e Investigaciones Médicas, S.A. de C.V. (Rimsa), a pharmaceutical manufacturing and distribution company in Mexico, for $2.3 billion. It also established a new business venture with Takeda—Teva Takeda Yakuhin Ltd.—to address the growing importance of generics in Japan.
At the end of the year, Teva entered into an agreement to sell its royalties and other rights in Ninlaro (ixazomib) to a subsidiary of Takeda, for a $150 million upfront payment, with additional consideration of up to $150 million dependent on future sales. Also, it entered into a license agreement for research, development, manufacture and commercializing of Attenukine with a subsidiary of Takeda, for a $30 million upfront payment, with additional milestone payments of up to $280 million and royalties.