Bluebird bio Inc (NASDAQ:BLUE) announced planned updates to be presented at the 40th Annual J.P. Morgan Healthcare conference, including 2022 program milestones and financial outlook.
- 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.
