Bluebird Bio, Inc. (BLUE) 10-Q Quarterly Report May 2022

CAMBRIDGE, Mass. – May 9, 2022 – bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the first quarter ended March 31, 2022, and shared recent operational progress.

“For more than a decade, bluebird bio has helped chart the path for the field of gene therapy and today, we are closer than ever before to realizing our mission of bringing potentially curative gene therapies to patients and their families,” said Andrew Obenshain, chief executive officer, bluebird bio. “We have taken action to sharpen our focus and our finances, as the FDA completes its review of the beti-cel and eli-cel BLAs, and we prepare for the launch of two gene therapies in the second half of the year. In parallel, we are actively collecting the manufacturing comparability data required for lovo-cel and remain focused on submitting our BLA for sickle cell disease to the FDA in Q1 2023.”

RECENT HIGHLIGHTS

BETI-CEL AND ELI-CEL

•ADVISORY COMMITTEE MEETING ON JUNE 9-10, 2022 – On April 13, the U.S Food and Drug Administration (FDA) confirmed its plans to review betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) in an FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting that will take place over two days on June 9-10, 2022. The advisory committee will discuss the efficacy and safety data supporting the benefit/risk of beti-cel and eli-cel respectively, as well as safety information relevant to both therapies. If approved, beti-cel and eli-cel would be the Company’s first FDA approved therapies as an independent severe genetic disease company. An overview of the agenda was included in the Federal Register announcement posted on April 13. The full agenda will be determined by the FDA and included in briefing materials that will be posted by the FDA closer to the date of the advisory committee meeting.

LOVO-CEL

•CONTINUED PROGRESS TOWARD BLA SUBMISSION – bluebird bio has enrolled more than half of the patients in the HGB-210 study that will be needed to support manufacturing data requirements for the lovotibeglogene autotemcel (lovo-cel) biologics licensing application (BLA) and the Company is on track to submit a BLA to the FDA for sickle cell disease (SCD) in the first quarter of 2023. As previously communicated, the Company has treated all patients in HGB-206 Group C who will form the primary basis of efficacy for BLA submission, with the demonstration of analytical comparability and validation of the commercial manufacturing process as the key remaining actions prior to submission of the planned BLA. Enrollment and dosing for patients 18 and older are continuing in the HGB-210 study and the Company remains in active dialogue with the FDA about the resolution of the partial clinical hold for patients under 18.

COMPANY

•RESTRUCTURING UPDATE – On April 5, 2022, bluebird bio announced a comprehensive restructuring intended to deliver up to $160 million in cost savings over the next two years,

The following information was filed by Bluebird Bio, Inc. (BLUE) on Monday, May 9, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Bluebird Bio, Inc.'s 10-Q Quarterly Report:

Financial - Expense Highlight
We expect to continue to incur significant expenses and operating losses for at least the next several years, as we: fund activities related to the potential commercial launches of our late-stage product candidates in the United States; seek regulatory approval for our product candidates; scale our manufacturing capabilities in support of potential commercialization following any regulatory approvals; conduct clinical studies for our clinical programs in -thalassemia and SCD; and potentially increase research and development-related activities for the discovery and development of new product candidates and technologies in severe genetic diseases.

Financial - Expense Highlight
The decrease of $27.5 million was primarily due to the following: 23 Table of Contents $25.8 million of decreased employee compensation, benefit, and other headcount-related expenses, which is primarily driven by a decrease of $13.1 million in stock-based compensation expense due to an overall decrease in the value of awards and by stock-based compensation expense incurred related to our employee retention program in 2021; and $1.6 million of decreased costs related to commercial readiness activities due to our decision to focus our efforts on the U.S. market for beti-cel, eli-cel, and lovo-cel.
Other - Other Highlight
The mitigating effect of our plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.
Financial - Income Highlight
The decrease in interest income, net was primarily related to lower interest income earned on investments due to an overall decrease in investments.
Financial - Expense
We anticipate that our selling,...Read more
Financial - Cash Flow
Our expectation to generate operating...Read more
Financial - Expense
We do not allocate personnel-related...Read more
Legal - Other
We disclaim any obligation, except...Read more
Revenue - Geography
Since our inception in 1992,...Read more
Financial - Expense
We allocate salary and benefit...Read more
Financial - Cash Flow
The separation of our oncology...Read more
Financial - Expense
The net decrease of $4.9...Read more
Other - Other
In accordance with Accounting Standards...Read more
Financial - Expense
During the three months ended...Read more
Other - Other
We have concluded the likelihood...Read more
Revenue - Product
The $251.4 million decrease in...Read more
Financial - Expense
As a result, we anticipate...Read more
Financial - Expense
Costs for certain development activities...Read more
Financial - Expense
The duration, costs, and timing...Read more
Revenue - Product
The $78.0 million decrease in...Read more
Revenue - Product
20 Table of Contents Other...Read more
Financial - Cash Flow
We have incurred losses and...Read more
Other - Other
The restructuring plan described above...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Bluebird Bio, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: BLUE
CIK: 1293971
Form Type: 10-Q Quarterly Report
Accession Number: 0001293971-22-000034
Submitted to the SEC: Mon May 09 2022 4:34:52 PM EST
Accepted by the SEC: Mon May 09 2022
Period: Thursday, March 31, 2022
Industry: Biological Products No Disgnostic Substances