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SUBSEQUENT EVENTS
6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

16. SUBSEQUENT EVENTS

 

The Company issued a termination notice to Brammer Bio MA, LLC, an affiliate of Thermo Fisher Scientific, Inc. (“Thermo”) on July 18, 2024 to terminate the development, commercial manufacturing, and supply agreement, as related to the Company's adherent manufacturing process for its gene therapy programs. The termination will be effective as of August 21, 2024 and the Company is currently performing its analysis of the financial impact of the termination. As of the date of this report, the Company expects to record between approximately $55.0 million to $65.0 million in additional expense as a result of this termination for the three and nine months ended September 30, 2024. This range is the net impact of any expected termination expenses and write-offs and the reduction to operating expense for applicable reimbursable costs under the Roche Agreement. As the Company had yet to obtain regulatory approval to produce commercial supply of ELEVIDYS at Thermo manufacturing facilities prior to the issuance of this termination notice, the Company will record these amounts as research and development expenses in the three and nine months ended September 30, 2024.

 

The Company is analyzing any further impact from the termination that will be recorded for the three and nine months ended September 30, 2024.

 

For more information related to Thermo, please read Note 21, Commitments and Contingencies to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.