bluebird bio (BLUE) Initiates Restructuring to Reduce Operating Expenses

Following a review of its strategic priorities, bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Company is initiating a comprehensive restructuring intended to deliver up to $160 million in cost savings over the next two years.

bluebird intends to sharpen its focus on near-term catalysts, including anticipated FDA approvals for its gene therapies for beta-thalassemia and cerebral adrenoleukodystrophy in 2022, and the potential submission of a biologics license application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease planned in the first quarter of 2023. The Company expects to maintain targeted research efforts focused on in vivo lentiviral vector (LVV) gene therapy and will deprioritize direct investments in reduced toxicity conditioning and cryopreserved apheresis.

The initiative is expected to reduce the Company’s cash burn in 2022 to less than $340 million, with a 35 to 40 percent reduction in operating costs anticipated by year-end 2022, which is expected to be reflected in bluebird’s operating budget for 2023. As part of the changes, bluebird plans to reduce its workforce by approximately 30%. The restructuring is expected to extend the Company’s cash runway into the first half of 2023.

“Over more than a decade, bluebird has made remarkable advances across research, development and manufacturing of gene therapies, and has set the standard for scientific understanding in this rapidly expanding field,” said Andrew Obenshain, chief executive officer, bluebird bio. “Today, we are taking decisive action to extend our cash runway, and put bluebird in a stronger position to execute on our strategic priorities and ultimately bring potentially curative gene therapies to patients and their families. The decision to reduce our workforce in support of a more focused set of priorities was not taken lightly, and we are grateful to every bluebird who has helped to progress the field of gene therapy and championed our mission.”

Cost savings and the extended cash runway generated through the restructuring are intended to bring bluebird through crucial upcoming milestones while the Company continues to evaluate additional financing options, including public or private equity financings and monetizing any priority review vouchers that may be issued upon approval of beti-cel or eli-cel.

If approved, betibeglogene autotemcel (beti-cel) for beta-thalassemia and elivaldogene autotemcel (eli-cel, Lenti-D™) for cerebral adrenoleukodystrophy will be the first ex-vivo LVV gene therapies available in the US. The FDA has set PDUFA goal dates of August 19, 2022 for beti-cel and September 16, 2022 for eli-cel. The therapies are expected to be reviewed in consecutive FDA advisory committee meetings tentatively scheduled for June 9 and 10, 2022.

Investor Conference Call Information

bluebird bio will host a call for analysts and investors today, April 5, 2022 at 8:00 am ET. Investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 7259545.

To access the live webcast of bluebird’s presentation, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird website for 90 days following the event.

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