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21 Jun 2016

Impax signs definitive agreements to acquire generic products

The agreements include the return to Impax of its rights to its pending abbreviated new drug application for the generic equivalent to Concerta (methylphenidate hydrochloride).

Impax Laboratories has signed definitive agreements with Teva Pharmaceutical Industries and affiliates of Allergan for the acquisition of a broad portfolio of generic products across solid oral, inhalable, injectable and topical dosage forms and the return to Impax of its rights to its pending abbreviated new drug application (ANDA) for the generic equivalent to Concerta (methylphenidate hydrochloride) (the "Transaction") for an aggregate purchase price of $586 million.

Upon closing of the Transaction, Impax is expected to add

  • A portfolio of 15 currently marketed generic products
  • One approved generic product and two approved strengths of a currently marketed product, which have not yet launched
  • One pipeline generic product and one pipeline strength of a currently marketed product, which are pending FDA approval
  • The full commercial rights to Impax's pending ANDA for the generic equivalent to Concerta (methylphenidate hydrochloride), a product previously partnered with Teva
  • One generic product under development.
  • "The anticipated acquisition of these currently marketed and pipeline products fits with our strategic priorities of maximizing our generic platform, optimizing R&D and accelerating business development to create long term growth," said Fred Wilkinson, President and CEO of Impax. "Through this transaction, we will be expanding our portfolio of difficult-to-manufacture or limited-competition products and maximizing utilization of our existing manufacturing facilities in Hayward, California and Taiwan. The acquisition of full commercial rights to generic Concerta provides an additional opportunity to add another valuable near term launch and accentuates the strength of our internal R&D program."

    Upon closing, the immediately accretive transaction will provide Impax with a profitable and growing commercialized portfolio of products. The acquired marketed generic products generated approximately $150 million in net sales and approximately $100 million in gross profit in 2015. According to IMS Health (NSP), the pending and development pipeline programs are estimated to have U.S. brand and generic sales of approximately $3.1 billion for the 12 months ending in March 2016. The aggregate purchase price of $586 million for the portfolio of products will be funded with existing cash and $400 million in new fully committed term loans.

    "We are excited about the opportunity to create long-term value and efficiently deploy our strong balance sheet. Following the completion of this acquisition, we will continue to have an efficient capital structure with our net debt to trailing 12 months adjusted pro-forma EBITDA ratio of approximately 2.1 times," Wilkinson continued. "We will be well positioned to continue to invest in organic growth as well as judiciously pursue strategic business development and merger and acquisition opportunities that can strengthen our portfolio and create long-term stockholder value."

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