Bluebird Bio reports Q4 EPS (38c), consensus (44c)

Reports Q4 revenue $.06M vs $1.6M last year. The Company’s cash and cash equivalents, marketable securities and restricted cash balance was approximately $227 million, as of December 31. As bluebird bio launches two first-in-class gene therapies and readies its third investigational gene therapy for SCD for the commercial setting, full-year 2023 cash burn is expected to be in the range of $270-$300M, as previously guided. Based on current operating plans, bluebird expects its cash, cash equivalents, restricted cash and marketable securities, including the net proceeds from the sale of its second priority review voucher of $93M and net proceeds of $131M 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. This runway includes approximately $45M of restricted cash, which is currently unavailable for use.."Following two milestone FDA approvals in 2022, bluebird is now emerging as a commercial gene therapy leader, fueled by strong momentum and uptake for both ZYNTEGLO and SKYSONA across patients, payers and providers," said Andrew Obenshain, chief executive officer, bluebird bio. "We also remain laser focused on our lovo-cel BLA for sickle cell disease. Following feedback from the FDA in February, bluebird submitted additional information related to CMC comparability analyses to the FDA in early March; we anticipate a response from the Agency within a matter of weeks. Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease, with more than 50 patients treated and multiple patients followed for more than six years. We remain extremely confident in the quality of our BLA submission. Most importantly, we know that patients and their families are waiting, and we will move quickly to expedite our BLA submission, pending alignment with FDA on product comparability."