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Sep 30, 2023
Bluebird Bio Q3 2023 Earnings Report
Reported financial results and highlighted operational progress with continued strong commercial launch for ZYNTEGLO® and SKYSONA®.
Key Takeaways
Bluebird Bio reported a net revenue of $12.4 million for Q3 2023, primarily driven by SKYSONA and ZYNTEGLO product revenue. The company's cash, cash equivalents, marketable securities, and restricted cash balance was approximately $227 million as of September 30, 2023. They anticipate full-year 2023 net cash burn to be in the range of $270-$300 million.
Continued strong commercial launch for ZYNTEGLO® and SKYSONA® with 22 patient starts across both programs to date.
Ended quarter with $227M in cash, cash equivalents, marketable securities and restricted cash.
Entered into advance agreement to sell priority review voucher, if granted, for $103 million.
Lovo-cel Biologics Licensing Application (BLA) review remains on track with a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.
Bluebird Bio
Bluebird Bio
Forward Guidance
Bluebird bio anticipates commercial launch of lovo-cel in early 2024, is on track to scale to 40-50 activated QTCs by the end of 2023, and anticipates 5-10 patient starts for SKYSONA this year.
Positive Outlook
- Commercial launch of lovo-cel anticipated in early 2024.
- Company is on track to scale to 40-50 activated QTCs by the end of 2023.
- SKYSONA continues to anticipate 5-10 patient starts this year as previously guided.
- Potential $103 million from the sale of a Rare Pediatric Disease Priority Review Voucher (PRV).
- FDA has set a PDUFA goal date for lovo-cel for December 20, 2023.
Challenges Ahead
- bluebird anticipates full-year 2023 net cash burn to be in the range of $270-$300 million
- Cash, cash equivalents and marketable securities including anticipated cash flows from operations, and excluding $53 million of restricted cash, will be sufficient to meet bluebird’s planned operating expenses and capital expenditure requirements into the second quarter of 2024.
- Delays and challenges in commercialization and manufacturing of products
- Risk that the company may not receive a Priority Review Voucher upon potential approval of lovo-cel or that lovo-cel may not be approved in the timeframe we anticipate or at all
- Substantial doubt exists regarding our ability to continue as a going concern