CELGENE CORPORATION (NASDAQ:CELG) Files An 8-K Costs Associated with Exit or Disposal ActivitiesItem 2.05
On October 19, 2017, Celgene Corporation (the “Company”) issued a press release to provide an update on the GED-0301 (mongersen) inflammatory bowel disease program. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
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.
This Item 2.05 contains forward-looking statements, including, but not limited to, statements related to the expected costs associated with discontinuance of the Trials. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. A further description of the risks and uncertainties relating to the business of the Company is contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission (the “SEC”), and the Company’s subsequent current and periodic reports filed with the SEC. Except as otherwise required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this Item 2.05 as a result of new information, future events or changes in its expectations.
| Item 2.06 | Material Impairments. |
The information required by this Item is incorporated by reference from Item 2.05 above.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit 99.1 | – Press Release dated October 19, 2017 |
CELGENE CORP /DE/ ExhibitEX-99.1 2 tv477363_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 CELGENE PROVIDES UPDATE ON GED-0301 (MONGERSEN) INFLAMMATORY BOWEL DISEASE PROGRAM SUMMIT,…To view the full exhibit click here
About CELGENE CORPORATION (NASDAQ:CELG)
Celgene Corporation (Celgene) is a biopharmaceutical company. The Company together with its subsidiaries is engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. The Company’s primary commercial stage products include REVLIMID (lenalidomide), ABRAXANE (paclitaxel albumin-bound particles for injectable suspension), POMALYST/IMNOVID (pomalidomide), VIDAZA, azacitidine for injection (generic version of VIDAZA), THALOMID (thalidomide), OTEZLA (apremilast) and ISTODAX (romidepsin). The Company’s clinical trial activity includes trials across the disease areas of hematology, oncology, and inflammation and immunology.