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Jun 30, 2022
Bluebird Bio Q2 2022 Earnings Report
Reported financial results and business highlights for the second quarter and shared recent operational progress.
Key Takeaways
Bluebird Bio reported significant progress in the second quarter, with unanimous FDA advisory committee support for beti-cel and eli-cel. The company is focused on commercial readiness and anticipates launching both therapies in the fourth quarter of this year. The BLA submission for lovo-cel remains on track for the first quarter of next year.
Beti-cel received unanimous positive vote at FDA Advisory Committee meeting.
Eli-cel received unanimous positive vote at FDA Advisory Committee meeting.
bluebird bio remains on track to submit a BLA to the FDA for lovo-cel for sickle cell disease in the first quarter of 2023.
Ended quarter with $218M in restricted cash, cash and cash equivalents and marketable securities
Bluebird Bio
Bluebird Bio
Forward Guidance
bluebird bio anticipates potential FDA approval of beti-cel and eli-cel and plans for future regulatory submissions.
Positive Outlook
- FDA has set a PDUFA goal date for beti-cel for August 19, 2022
- If approved, the Company anticipates first apheresis in the fourth quarter of 2022 for beti-cel.
- FDA has set a PDUFA goal date of September 16, 2022 for eli-cel.
- If approved, the Company anticipates therapy availability in the fourth quarter of 2022 for eli-cel.
- The Company plans to submit its BLA for lovo-cel in Q1 2023.
Challenges Ahead
- The Company is in active communication with the FDA to resolve the lovo-cel partial clinical hold and resume enrollment and treatment of patients under the age of 18.
- The Company expects to complete vector and drug product analytical comparability in the fourth quarter of 2022.
- Risk that eli-cel and/or beti-cel may not be approved within the priority review timeframe or at all.
- Risk that any one or more of our product candidates, including eli-cel and/or beti-cel, will not be successfully developed, approved or commercialized.
- The Company is in active communication with the FDA to resolve the eli-cel clinical hold and anticipates the FDA’s questions may be resolved concurrent with the agency’s ongoing review of the Company’s BLA submission.