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Dec 31, 2022
Bluebird Bio Q4 2022 Earnings Report
Reported financial results and business highlights.
Key Takeaways
Bluebird Bio reported its Q4 and full year 2022 financial results, highlighting commercial launch progress for ZYNTEGLO® and SKYSONA®, and provided an update on the lovo-cel BLA submission for sickle cell disease.
Continued strong commercial launch for ZYNTEGLO® and SKYSONA® with 7 patient starts (cell collections) across both programs to date.
Provided update on Biologics License Application (BLA) submission for lovo-cel for sickle cell disease (SCD).
Submitted additional information related to CMC comparability analyses to the FDA in early March.
Anticipate a response from the Agency within a matter of weeks.
Bluebird Bio
Bluebird Bio
Forward Guidance
Bluebird bio anticipates commercial revenue in its Q1 2023 financial statement and expects full-year 2023 cash burn to be in the range of $270-$300 million.
Positive Outlook
- The Company anticipates reporting commercial revenue in its Q1 2023 financial statement, as previously guided.
- bluebird expects its cash, cash equivalents, restricted cash and marketable securities, including the net proceeds from the sale of its second priority review voucher (PRV) of $93 million and net proceeds of $131 million from its public offering in January, will be sufficient to meet bluebird’s planned operating expenses and capital expenditure requirements into the fourth quarter of 2024.
- The Company plans to request priority review for patients 12 and older with a history of vaso-occlusive events.
- bluebird continues to anticipate a commercial launch in early 2024, if approved.
- The Company is on track to scale to 40-50 centers by the end of 2023.
Challenges Ahead
- Full-year 2023 cash burn is expected to be in the range of $270-$300 million, as previously guided.
- This runway includes approximately $45 million of restricted cash, which is currently unavailable for use.
- delays and challenges in our commercialization and manufacturing of our products, including risks associates with demonstrating analytical comparability with respect to our lovo-cel program
- the risk that we may not realize expected cost savings from the restructuring, including the anticipated decrease in operational expenses, at the levels we expect
- the internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than expected which has caused us, and may in the future cause us to use cash more quickly than we expect or change or curtail some of our plans or both