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Jun 30, 2021
Bluebird Bio Q2 2021 Earnings Report
Reported financial results for Q2 2021 and provided operational updates, including a clinical hold on studies of elivaldogene autotemcel (eli-cel) and plans to complete business separation in 4Q 2021.
Key Takeaways
Bluebird Bio reported a net loss of $241.7 million for the second quarter of 2021, with total revenues of $7.5 million. The company is on track to complete its business separation in the fourth quarter of 2021 and is focusing its severe genetic disease (SGD) business on the U.S. market. The FDA has placed a clinical hold on studies of elivaldogene autotemcel (eli-cel) following a safety report.
On track to complete planned business separation in 4Q 2021; each company launching with approximately 24 months of runway following separation.
Severe genetic disease (SGD) business to scale back operations in Europe to focus on the U.S. market.
ABECMA generates strong performance in first quarter of U.S. launch.
FDA has placed studies of elivaldogene autotemcel (eli-cel, Lenti-D™) for cerebral adrenoleukodystrophy (CALD) on clinical hold following safety report; other SGD and oncology programs not impacted.
Bluebird Bio
Bluebird Bio
Forward Guidance
bluebird anticipates the separation of its SGD and oncology businesses into two independent, publicly traded companies (bluebird bio and 2seventy bio) to be completed by the end of 2021. The company is on track to complete its rolling BLA submission to the FDA for beti-cel in 3Q 2021. Subject to resolution of the clinical hold, the company plans to complete its rolling BLA submission to the FDA for eli-cel in 2021.
Positive Outlook
- bluebird anticipates the separation of its SGD and oncology businesses into two independent, publicly traded companies (bluebird bio and 2seventy bio) to be completed by the end of 2021.
- The company is on track to complete its rolling BLA submission to the FDA for beti-cel in 3Q 2021.
- Subject to resolution of the clinical hold, the company plans to complete its rolling BLA submission to the FDA for eli-cel in 2021.
- The company is continuing to evaluate the impact of the recently-lifted clinical hold on bb1111 and plans to continue to work closely with the FDA in their review of these events to provide an update on the company’s development plan and timeline for submission for regulatory approval of bb1111 by year end.
- The company plans to present clinical data from its ongoing HGB-206 clinical study of bb1111 by the end of 2021.
Challenges Ahead
- The risk that the Company may not be able to execute a planned orderly wind down of European operations with the timing that we anticipated.
- The Company may not be successful in negotiating or finalizing a license or other partnership transaction for the European commercial rights to severe genetic disease programs.
- The risk that additional insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time.
- The risk that the FDA may impose a clinical hold on additional programs utilizing lentiviral vectors.
- The risk that we may not be able to address the FDA’s concerns regarding eli-cel quickly or at all.