Celgene is in the process of contacting the clinical investigators conducting the GED-0301 phase III REVOLVE (CD-002) trial in Crohn’s disease (CD) and the SUSTAIN (CD-004) extension trial (the “Trials”) regarding the discontinuance of the Trials. We are continuing to assess the financial impacts of discontinuing the Trials.
As a result of the decision to discontinue the Trials, Celgene concluded on October 18, 2017 that it will recognize a fourth-quarter 2017 charge to earnings related to the significant impairment of the approximately $1,600 million GED-0301 In-Process Research and Development (IPR&D) asset, as well as wind-down costs associated with discontinuing the Trials and certain development activities, partially offset by a benefit related to the significant reduction in the approximately $1,400 million of GED-0301 contingent consideration liabilities. The exact amount of the net pre-tax charge to earnings has not yet been determined, but is estimated to be in the range of $300 million to $500 million, or $0.27 to $0.45 per diluted share after tax. Approximately 50 percent of the net charge will require cash payments.