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Collaborative and other licensing arrangements
9 Months Ended
Sep. 30, 2016
Collaborative and Other Licensing Arrangements Disclosure [Abstract]  
Collaborative and other licensing arrangements
Collaborative and other licensing arrangements
The Company is party to certain collaborative or licensing arrangements. In some of these arrangements, Shire and the licensee are both actively involved in the development and commercialization of the licensed product and have exposure to risks and rewards dependent on its commercial success.
Out-licensing arrangements
The Company has entered into various collaborative and licensing arrangements where it has licensed certain product or intellectual property rights for consideration such as up-front payments, development milestones, sales milestones and/or royalty payments. Under the terms of these collaborative and licensing arrangements, the Company may receive development milestone payments up to an aggregate amount of $17.3 million and sales milestones up to an aggregate amount of $17.7 million. The receipt of these substantive milestones is uncertain and contingent on the achievement of certain development milestones or the achievement of a specified level of annual net sales by the licensee. In the three and nine months ended September 30, 2016, the Company received cash related to up-front and milestone payments of $3.0 million and $3.5 million, respectively, compared to $nil and $12.6 million, respectively, in the three and nine months ended September 30, 2015. In the three and nine months ended September 30, 2016, the Company recognized milestone income of $1.7 million and $4.0 million, respectively (2015: $0.5 million and $1.5 million, respectively), in other revenues, and $16.4 million and $47.7 million, respectively (2015: $13.8 million and $37.2 million, respectively), in product sales for shipment of product to the relevant licensee.
Collaboration and in-licensing arrangements
The Company is party to various collaborative and in-licensing arrangements, many of which were acquired through the acquisition of Baxalta. The Company also entered into a new collaboration agreement during the nine months ended September 30, 2016. These agreements generally provide for commercialization rights to a product or products being developed by the counterparty, and in exchange often resulted in an upfront payment upon execution of the agreement and an obligation that the Company make future development, regulatory approval or commercial milestone payments as well as royalty payments. The following is a description of the Company's significant collaboration agreements acquired by the Company through the acquisition of Baxalta or entered into by the Company during the nine months ended September 30, 2016. The acquisition-date fair value of the collaboration agreements acquired from Baxalta was included in the IPR&D.
Precision BioSciences
In June 2016, the Company acquired a strategic immuno-oncology collaboration with Precision BioSciences (“Precision”), a private biopharmaceutical company based in the United States, specializing in genome editing technology. The Company acquired the collaboration through the acquisition of Baxalta, which previously entered into the agreement in February 2016. Together, Shire and Precision will develop chimeric antigen receptor (“CAR”) T cell therapies for up to six unique targets, with the first program expected to enter clinical studies in late 2017. On a product-by-product basis, following successful completion of early-stage research activities up to Phase 2, Shire will have exclusive option rights to complete late-stage development and worldwide commercialization. Precision is responsible for development costs for each target prior to option exercise. Precision also has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States. As of the date the agreement was acquired, June 3, 2016, and as of the balance sheet date, the Company had the potential to make future payments related to option fees and development, regulatory and commercial milestones totaling up to $1.6 billion, in addition to future royalty payments on worldwide sales.
Symphogen
In June 2016, the Company acquired a research, option and commercial agreement with Symphogen, a private biopharmaceutical company headquartered in Denmark that is developing recombinant antibodies and antibody mixtures. The Company acquired the agreement through the acquisition of Baxalta, which previously entered into the agreement in December 2015. Under the terms of the agreement, the Company has options to obtain exclusive licensing rights for four specified proteins in development for the treatment of immune-oncology diseases as well as two additional proteins that may be selected at a later date. Each option is exercisable for a period of 90 days when each protein is ready for Phase 2 clinical trials. Symphogen is responsible for development costs for each protein until option exercise, at which point Shire would become responsible for development costs.
Each option exercise fee is variable depending on when it is exercised, with a maximum exercise price of up to €20 million for each protein. As of the date the agreement was acquired, June 3, 2016 and as of the balance sheet date, the Company had the potential to make additional future payments of up to approximately €1.2 billion related to development, regulatory and commercial milestones achieved after option exercise for all six proteins, in addition to future royalty payments.
Merrimack Pharmaceuticals, Inc.
In June 2016, the Company acquired an exclusive license agreement with Merrimack Pharmaceuticals, Inc. (“Merrimack”) relating to the development and commercialization of ONIVYDE (nanoliposomal irinotecan injection), also known as “nal-IRI” or MM-398. The Company acquired the agreement through the acquisition of Baxalta, which previously entered into the agreement in September 2014. The arrangement includes all potential indications for nal-IRI across all markets with the exception of the United States and Taiwan. The first indication being pursued is for the treatment of patients with metastatic pancreatic cancer who were previously treated with gemcitabine-based therapy. As of the date the agreement was acquired, June 3, 2016 and as of the balance sheet date, the Company had the potential to make future payments of up to approximately $678 million related to the achievement of development, regulatory and commercial milestones, in addition to future royalty payments.
Coherus Biosciences, Inc.
In June 2016, the Company acquired a license agreement with Coherus Biosciences, Inc. (“Coherus”) to develop and commercialize a biosimilar to ENBREL® (etanercept). The Company acquired the agreement through the acquisition of Baxalta, which previously entered into the agreement in August 2013. The Company also obtained the right of first refusal to certain other biosimilars in the collaboration. Under the terms of the agreement, Coherus was responsible for the development plan, preparation of regulatory filings, and manufacture of the product, subject to certain cost reimbursement by the Company. In September 2016, the Company terminated the licensing agreement with Coherus in accordance with its terms.
Momenta Pharmaceuticals, Inc.
In June 2016, the Company acquired an exclusive license agreement with Momenta Pharmaceuticals, Inc. (“Momenta”) to develop and commercialize biosimilars, including adalimumab (BAX 2923), a biosimilar product candidate for HUMIRA® (adalimumab). The agreement was acquired through the acquisition of Baxalta, which initially entered into the agreement in February 2012. The arrangement includes specified funding by the Company, as well as other responsibilities, relating to development and commercialization activities. In September 2016, the Company exercised its right to terminate its license agreement with Momenta. The effective date of the termination is twelve months from the date that Momenta received the Company’s written notice of termination. Prior to the effective date of the termination, the Company and Momenta are required to satisfy certain ongoing obligations.
Pfizer Inc.
In July 2016, the Company licensed the global rights to all indications for SHP647 from Pfizer Inc. SHP647 is an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease. Under the terms of the agreement, Pfizer received an upfront payment of $90 million, and is eligible to receive between $75 million to $460 million in milestone payments based on clinical, regulatory and commercialization milestones and low double-digit royalties on any potential sales if the product is approved.
Other arrangements
SFJ Pharmaceuticals Group
In June 2015, Baxalta entered into a co-development agreement with SFJ Pharmaceuticals IX, L.P., a SFJ Pharmaceuticals Group company (“SFJ”) relating to BAX 2923, whereby SFJ would fund specified development costs related to the BAX 2923 program, in exchange for payments in the event the product obtains regulatory approval in the United States and Europe. There were certain termination provisions that could have triggered payment of the contingent success payments prior to regulatory approval.
The preliminary fair value of the assumed contingency was recorded as a long-term liability at June 3, 2016 and as of the balance sheet date, as part of Company’s purchase accounting for the Baxalta acquisition. The fair value of the assumed contingency on the date of acquisition was $288.6 million.
This co-development agreement was terminated by mutual agreement of the Company and SFJ in September 2016 and the Company made a one-time $288.0 million payment to SFJ in connection with the termination, in full satisfaction of the Company’s financial obligations under the agreement.