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Collaborative Agreements
3 Months Ended
Mar. 31, 2015
Collaborative Agreements  
Collaborative Agreements

 

P.COLLABORATIVE AGREEMENTS

 

Our commercial strategy includes the formation of collaborations with other pharmaceutical companies to expand our portfolio through the in-license or acquisition of additional pharmaceutical products or companies, including revenue-generating commercial products and late-state development assets.

 

In December 2014, we terminated our License, Development and Commercialization Agreement (the “Takeda Agreement”), as amended in June 2012 (the “Amended Takeda Agreement”), with Takeda (the “Takeda Termination Agreement”). Under the terms of the Amended Takeda Agreement, Takeda had exclusive rights to develop and commercialize Feraheme as a therapeutic agent in certain agreed-upon territories outside of the U.S. We are in the process of regaining all worldwide development and commercialization rights for Feraheme following the transfer of the outstanding marketing authorizations to us. Pursuant to the Takeda Termination Agreement, we and Takeda have agreed to effectuate the termination of the Amended Takeda Agreement on a rolling basis, whereby the termination will be effective for a particular geographic territory (e.g., countries under the regulatory jurisdictions of Health Canada, the European Medicines Agency and SwissMedic) upon the earlier of effectiveness of the transfer to us or a withdrawal of the marketing authorization for such territory, with the final effective termination date to be on the third such effective date. In February 2015, we and Takeda mutually decided to withdraw the marketing authorization for Rienso in the EU and Switzerland, which was effective as of April 13, 2015. We are currently assessing the commercial opportunity for Feraheme in Canada and are working with Takeda to transition the marketing authorization to us.

 

In connection with the execution of the original Takeda Agreement, we received a total of $61.0 million in upfront payments from Takeda in 2010, which we recorded as deferred revenue and were recognizing into revenues on a straight-line basis over a period of ten years from March 31, 2010, the date on which we originally entered the Takeda Agreement, which represented the then current patent life of Feraheme and our best estimate of the period over which we were to substantively perform our obligations. In addition, during 2012, we received an aggregate of $18.0 million in milestone payments from Takeda associated with the commercial launches of Feraheme in the EU and Canada, which we deemed to be non-substantive milestone payments and were amortizing over the original life of the Takeda Agreement.

 

In addition, in consideration for the early termination of the Amended Takeda Agreement and the activities to be performed by us earlier than contemplated under the Amended Takeda Agreement, and in lieu of any future cost-sharing and milestone payments contemplated by the Amended Takeda Agreement, Takeda agreed to make certain payments to us, subject to certain terms and conditions, including up to approximately $6.7 million in connection with clinical study obligations, pharmacovigilance activities, regulatory filings and support, commercialization and back-office support and distribution expenditures and a $3.0 million milestone payment payable subject to certain regulatory conditions.

 

During the three months ended March 31, 2015, we recognized $12.0 million in revenues associated with the amortization of the remaining deferred revenue balance and have recorded it in license fee, collaboration and other revenues in our condensed consolidated statement of operations. As of March 31, 2015, all remaining upfront, milestone and other payments received to date have been classified as short-term deferred revenues as we expect to recognize the remaining $33.6 million balance of the deferred revenue related to Takeda within the next nine months.