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Sep 30, 2021
Bluebird Bio Q3 2021 Earnings Report
Bluebird Bio focused on severe genetic diseases after completing the separation of bluebird bio and 2seventy bio.
Key Takeaways
Bluebird Bio reported total revenues of $22.7 million for the third quarter ended September 30, 2021, compared to $19.3 million for the three months ended September 30, 2020. Net loss was $216.8 million for the three months ended September 30, 2021, compared to $194.7 million for the three months ended September 30, 2020. As of September 30, 2021, cash, cash equivalents and marketable securities were $970.7 million.
Completed the tax-free spin-off of its oncology business, 2seventy bio, Inc. on November 4, 2021.
bluebird bio will continue its work focused on severe genetic diseases.
Secured additional capital through the close of a private financing and completion of the sale of manufacturing facility in North Carolina.
Completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for beti-cel.
Bluebird Bio
Bluebird Bio
Forward Guidance
bluebird bio anticipates several milestones including the acceptance of the BLA to the US Food and Drug Administration for beti-cel for beta-thalassemia expected this month and The BLA filing for elivaldogene autotemcel (eli-cel, Lenti-D™) for patients with cerebral adrenoleukodystrophy (CALD) is on track for the end of 2021.
Positive Outlook
- Acceptance of the BLA to the US Food and Drug Administration for beti-cel for beta-thalassemia expected this month.
- The BLA filing for elivaldogene autotemcel (eli-cel, Lenti-D™) for patients with cerebral adrenoleukodystrophy (CALD) is on track for the end of 2021.
- Company plans to host an investor event on November 18th, 2021, to share further detail on its sickle cell disease program and path to regulatory approval.
- bluebird will present new data on beti-cel and bb1111 at ASH 2021, including long-term results for beti-cel in adult and pediatric patients with beta-thalassemia, new analyses from Groups A&C of the ongoing Phase 1/2 HGB 206 study of bb1111 for sickle cell disease, and sustained improvements in patient reported quality of life in Group C.
- Increased fiscal discipline, including through projected real estate savings with the move of the Company’s headquarters to Assembly Row in Somerville, Massachusetts, and the wind down of European operations, together with the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of biologics licensing applications for beti-cel and eli-cel will be sufficient to fund operations for bluebird bio into 2023 under current business plans.
Challenges Ahead
- The risk that the Company may not be able to execute an orderly wind down of European operations with the timing or at a cost that we anticipated.
- 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.
- The risk that the FDA may require additional information, testing, or monitoring that results in a delay to our regulatory submission plans including our BLAs for beti-cel and eli-cel.