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In 2022, bluebird is focused on the FDA review of two gene therapies – betibeglogene autotemcel (beti-cel) for beta-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD).
The Company is prepared to launch both beti-cel and eli-cel for patients in the U.S. in mid-2022 if approved by the FDA.
An FDA Advisory Committee to discuss the Biologics License Application (BLA) for beti-cel is anticipated on March 9, 2022.
Bluebird bio also expects to complete manufacturing commercial drug product validation lots for its third gene therapy, lovotibeglogene autotemcel (lovo-cel), for sickle cell disease in mid-2022.
The Company is evaluating the impact of the ongoing partial clinical hold of lovo-cel on the projected timing of Q1 of 2023 for the submission of the BLA.
2022 Financial Outlook: The Company's preliminary restricted cash, cash equivalents, and marketable securities balance were approximately $442 million as of December 31, 2021.
As bluebird bio advances its late-stage pipeline assets to the commercial setting, full-year 2022 cash burn is expected to be less than $400 million.
The Company plans to explore the sale of priority review vouchers expected to be issued with the U.S. approvals of BLAs for beti-cel and eli-cel. Approximately $150-200 million in non-dilutive cash inflows could potentially be realized from the sales, which would extend the current cash runway into 2023.
The Company is also exploring multiple additional financing opportunities while focusing on further cost efficiencies.
Price Action: BLUE shares are up 3.72% at $9.76 during the market session on the last check Tuesday.
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