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Intangible Assets and Goodwill
12 Months Ended
Dec. 31, 2015
Goodwill And Intangible Assets Disclosure [Abstract]  
Intangible Assets and Goodwill

NOTE 5. INTANGIBLE ASSETS AND GOODWILL

Intangible assets consist of IPR&D acquired from business acquisitions. The Company accounts for IPR&D as indefinite-lived intangible assets until regulatory approval or discontinuation of the related R&D efforts. Upon obtaining regulatory approval, the Company reclassifies the IPR&D as a definite-lived intangible asset and determines the economic life for amortization purposes. The Company assesses the impairment of indefinite-lived intangible assets and goodwill on an annual basis or more frequently whenever events or changes in circumstances may indicate that the carrying value might not be recoverable.

During the fourth quarter of 2015, the Company recorded a $30.0 million impairment charge related to its IPR&D asset for MDV9300 as a result of an extended clinical development timeline and other factors. In the fourth quarter, the Company concluded its testing that revealed MDV9300 is not an anti-PD-1 antibody and, after advising the FDA of this conclusion in early-January 2016, its IND was placed on partial clinical hold pending revision of all related study documentation characterizing MDV9300 as an anti-PD-1 antibody. While the Company believes the partial clinical hold does not relate to concerns regarding the safety or previously-observed efficacy of MDV9300, the Company extended its clinical study timelines which, in turn, gave rise to changes to the significant inputs to its IPR&D valuation including forecasted revenues and probabilities of success. The quantitative assessment resulted in a net impairment charge, which the Company recorded as a reduction in the IPR&D asset and an increase to R&D expense in the fourth quarter of 2015.

 

The following table summarizes the Company’s indefinite-lived intangible assets:

 

 

 

December 31,

 

 

 

2015

 

 

2014

 

Indefinite-lived intangible asset – MDV3800

 

$

573,299

 

 

 

 

Indefinite-lived intangible asset – MDV9300

 

 

71,000

 

 

 

101,000

 

Total

 

$

644,299

 

 

$

101,000

 

 

The following table summarizes the changes in the carrying amount of goodwill:

 

 

Year Ended

December 31, 2015

 

Goodwill:

 

 

 

Balance at beginning of period

$

10,000

 

Goodwill at acquisition date – MDV3800

 

8,643

 

Balance at end of period

$

18,643