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Sep 30, 2020
Bluebird Bio Q3 2020 Earnings Report
Reported financial results and business highlights for the third quarter ended September 30, 2020, and shared recent operational progress.
Key Takeaways
Bluebird Bio reported a net loss of $194.7 million on revenues of $19.3 million for the third quarter of 2020. The company is advancing its cell and gene therapy programs and anticipates multiple approvals in the U.S. and EU.
Confirmed general agreement with the FDA on the clinical data package for LentiGlobin for sickle cell disease (bb1111).
Intends to seek approval for beti-cel for all patients with transfusion-dependent β-thalassemia across all genotypes.
Completed treatment in the Phase 1 study (CRB-402) of bb21217 in patients with relapsed/refractory multiple myeloma (R/RMM).
The FDA has accepted for Priority Review their BLA for idecabtagene vicleucel (ide-cel; bb2121).
Bluebird Bio
Bluebird Bio
Forward Guidance
Bluebird Bio anticipates key regulatory milestones and clinical data presentations in the near term, with a focus on advancing its gene therapy programs and securing approvals for its product candidates.
Positive Outlook
- Completing the BLA submission to the U.S. FDA for LentiGlobin for SCD in 2022.
- Completing a rolling BLA submission to the U.S. FDA for beti-cel in mid-2021.
- FDA has set a PDUFA goal date of March 27, 2021 for the approval of ide-cel (bb2121) in patients with relapsed and refractory multiple myeloma.
- Completing the BLA submission to the U.S. FDA for eli-cel in mid-2021.
- First ZYNTEGLO commercial patients treated in Europe by the end of 2020.
Challenges Ahead
- Adjusting its submission timing for LentiGlobin for SCD to late 2022 due to FDA feedback and COVID-19 related shifts.
- Potential delays in BLA submission for LentiGlobin for SCD if the FDA does not accept comparability plans.
- Risk that the submission of BLA for ide-cel is not accepted for filing by the FDA or approved in the expected timeline.
- Risk of cessation or delay of ongoing or planned clinical studies due to the COVID-19 pandemic.
- Challenges in the commercial launch of ZYNTEGLO in the European Union, including managing the supply chain and obtaining sufficient coverage or reimbursement.