Loading...
•
Mar 31, 2022
Bluebird Bio Q1 2022 Earnings Report
Reported first quarter 2022 financial results and highlighted operational progress.
Key Takeaways
Bluebird Bio reported a net loss of $122.2 million for the first quarter of 2022, with total revenue of $1.9 million. The company is restructuring to reduce operating costs and expects full-year 2022 cash burn to be less than $340 million. They ended the quarter with $312 million in restricted cash, cash equivalents, and marketable securities.
BLAs for beti-cel and eli-cel to be discussed at an FDA Advisory Committee Meeting on June 9-10, 2022.
Company restructuring initiated in April to reduce operating costs by 35 to 40 percent by year-end 2022.
Ended quarter with $312M in restricted cash, cash and cash equivalents and marketable securities.
The Company plans to submit its BLA for lovo-cel in Q1 2023.
Bluebird Bio
Bluebird Bio
Forward Guidance
bluebird bio anticipates several milestones in the coming months, including FDA decisions on beti-cel and eli-cel, completion of manufacturing validation lots for lovo-cel, and submission of the BLA for lovo-cel in Q1 2023.
Positive Outlook
- FDA has set a PDUFA goal date of August 19, 2022, for a decision on the approval of beti-cel.
- FDA has set a PDUFA goal date of September 16, 2022, for a decision on the approval of eli-cel.
- Company expects to confirm vector and drug product analytical comparability by Q4 2022.
- The Company plans to complete manufacturing of commercial drug product validation lots by mid-2022.
- The Company is in active communication with the FDA to resolve the partial clinical hold and resume enrollment and treatment of patients under the age of 18.
Challenges Ahead
- The company is still in active communication with the FDA to resolve the partial clinical hold.
- The internal and external costs required for ongoing and planned activities may be higher than expected.
- The efficacy and safety results from prior and ongoing clinical trials may not continue or be seen in additional patients.
- Additional insertional oncogenic or other reportable events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time.
- The company may encounter additional delays in the development of programs.