Explanatory Note
On September 12, 2019, Translate Bio, Inc. (the “Company”) filed a Current Report on Form8-K (the “Original Form8-K”), in which it disclosed, among other things, that in connection with its decision to discontinue the development of MRT5201 for the treatment of ornithine transcarbamylase (“OTC”) deficiency (the “OTC program”), the Company expected to incur anon-cash impairment charge in its statement of operations for the three and nine months ended September 30, 2019 associated with thein-process research and development intangible assets. The Company also disclosed that it planned to remeasure the contingent consideration liability related to the OTC program as a result of the discontinuation. The Company’s condensed consolidated balance sheet as of June 30, 2019 included $18.6 million ofin-process research and development intangible assets and $23.2 million in contingent consideration liability related to the OTC program.
At the time of filing the Original Form8-K, the Company disclosed that it had not yet been able to establish a meaningful estimate of the amount or range of amounts of the impairment charges or the impact of the remeasurement of the contingent consideration liability noted above.
The Company is filing this amended Current Report on Form8-K/A to amend the disclosure under Item 2.06 of the Original Form8-K. Except as stated herein, this Form8-K/A does not reflect events or transactions occurring after the filing date of the Original Form8-K or modify or update the disclosures contained therein that may have been affected by events or transactions occurring subsequent to such filing date.
| Item 2.06 | Material Impairments. |
This Form8-K/A is being filed to report that as a result of the discontinuation of the OTC program, on October 23, 2019, the Company determined the estimated amount of the impairment charge in its statement of operations for the three and nine months ended September 30, 2019 associated with thein-process research and development intangible assets to be approximately $18.6 million. Additionally, the Company estimates that the discontination of the OTC program will result in the removal of the $23.2 million in contingent consideration liability related to the OTC program for the three and nine months ended September 30, 2019. The Company does not expect to incur any future cash expenditures resulting from this impairment. The Company will disclose the final amounts in its Quarterly Report on Form10-Q for the quarter ended September 30, 2019.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form8-K/A contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding the Company’s expectations relating to impairment charges associated with the discontinuation of its OTC program. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: the Company’s ability to advance the development of its platform and programs under the timelines it projects, demonstrate the requisite safety and efficacy of its product candidates and replicate in clinical trials any positive findings from preclinical studies; the content and timing of decisions made by the U.S. Food and Drug Administration, other regulatory authorities and investigational review boards at clinical trial sites, including as it relates to ongoing and planned clinical trials; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the availability of significant cash required to fund operations; competitive factors; general economic and market conditions and other important risk factors set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form10-Q for the quarterly period ended June 30, 2019 and in any other subsequent filings made by the Company with the Securities and Exchange Commission. Any forward-looking statements contained in this Current Report on Form8-K/A speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
