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

SOMERVILLE, Mass. – November 7, 2022 – bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the third quarter ended September 30, 2022 and shared recent operational progress.

"The third quarter officially launched bluebird bio as a commercial gene therapy company, following FDA approvals of ZYNTEGLO for beta-thalassemia and SKYSONA for cerebral adrenoleukodystrophy," said Andrew Obenshain, CEO bluebird bio. "Positive momentum continues to build through the ZYNTEGLO launch and we are on track to complete our first cell collection this quarter. Additionally, we are readying SKYSONA for commercial availability and are on track to file our biologics licensing application for lovo-cel for sickle cell disease in Q1 2023. As a result of milestones in the quarter, we are adjusting our fourth quarter 2022 financial guidance to account for post-marketing commitment expenses and increased investment in current and upcoming launches, which will enable the Company to fully benefit from its first-in-class position. Today, we are also very pleased to welcome Chris Krawtschuk as bluebird's next chief financial officer. Chris brings significant experience leading and advising financial and capital strategies for a multitude of commercial organizations and will play a critical role in our financing strategy and the evolution of bluebird's balance sheet as a commercial company."

RECENT HIGHLIGHTS

ZYNTEGLO FDA APPROVAL AND COMMERCIAL LAUNCH PROGRESS

•On August 17, 2022, the U.S. Food and Drug Administration (FDA) approved ZYNTEGLO® (betibeglogene autotemcel), the first one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.

•Following approval, the Company has made significant progress on its first US commercial launch and remains on track for first apheresis (cell collection) in the fourth quarter of this year. Two months post approval, 27 patients have initiated benefits verification and approximately one-third of those patients have progressed to prior authorization. While we anticipate that not all patients will proceed with treatment, these early indicators demonstrate significant demand across a rare disease population. Of note, the process to initiate gene therapy treatment once a patient and their provider have decided it is right for them may take several weeks as the patient completes the consent process, benefits verification and prior authorization.

•bluebird has completed activation of all wave one qualified treatment centers (QTCs) and the Company’s QTC network is on track to reach low double digits by the end of the year, as previously guided. In addition to the Company’s planned list of QTCs, bluebird has received

The following information was filed by Bluebird Bio, Inc. (BLUE) on Monday, November 7, 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
The decrease in restructuring expenses is primarily related to the costs associated with the reduction in workforce as a result of our decision to reduce our EU workforce in Q3 2021 offset by the costs associated with the reduction in US workforce implemented in Q2 2022.

Financial - Expense Highlight
The decrease in restructuring expenses is primarily related to the costs associated with the reduction in workforce as a result of our decision to reduce our EU workforce in Q3 2021.
Financial - Income Highlight
The increase in interest income, net was primarily related to higher interest income earned on dividends related to the operating account.
Financial - Expense Highlight
The decrease of $50.6 million was primarily attributable to the following: $61.3 million of decreased employee compensation, benefit, and other headcount-related expenses, which is primarily driven by a decrease of $30.5 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 $5.3 million of decreased costs related to commercial readiness activities due to our decision to focus our efforts on the U.S. market for ZYNTEGLO, SKYSONA, and lovo-cel.
Financial - Expense Highlight
The decrease of $8.8 million was primarily attributable to the following: $14.3 million of decreased employee compensation, benefit, and other headcount-related expenses, which is primarily driven by a decrease of $8.3 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; $2.3 million of decreased costs related to commercial readiness activities due to our decision to focus our efforts on the U.S. market for ZYNTEGLO, SKYSONA, and lovo-cel; $1.6 million of decreased office expense related to reduced activities in various non-capex licenses; and $1.4 million of decreased consultants and professional service fees.
Financial - Expense
The net decrease of $45.7...Read more
Other - Other
The mitigating 21 Table of...Read more
Financial - Income
The decrease in interest income,...Read more
Financial - Expense
22 Table of Contents Research...Read more
Financial - Expense
We anticipate that our selling,...Read more
Revenue - Geography
Since our inception in 1992,...Read more
Financial - Cash Flow
Our expectation to generate operating...Read more
Financial - Expense
Business update In April 2022,...Read more
Financial - Expense
We do not allocate personnel-related...Read more
Financial - Expense
The net decrease of $20.5...Read more
Legal - Other
We disclaim any obligation, except...Read more
Financial - Expense
We allocate salary and benefit...Read more
Financial - Cash Flow
The separation of our oncology...Read more
Other - Other
In accordance with Accounting Standards...Read more
Other - Other
We have concluded the likelihood...Read more
Financial - Expense
We expect to continue to...Read more
Revenue - Product
The decrease of $0.9 million...Read more
Financial - Expense
As a result, we anticipate...Read more
Financial - Expense
The decrease is primarily attributable...Read more
Financial - Expense
Costs for certain development activities...Read more
Financial - Shares
As of September 30, 2022,...Read more
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As of September 30, 2022,...Read more
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Revenue - Product
The $354.4 million decrease in...Read more
Revenue - Product
The $199.2 million decrease in...Read more
Revenue - Product
Other revenue We have recognized...Read more
Revenue - Product
The $25.7 million decrease in...Read more
Financial - Cash Flow
We have incurred losses and...Read more
Financial - Shares
LLC ("Goldman") to sell shares...Read more
Other - Other
The restructuring plan described above...Read more
Other - Other
We have agreed to provide...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 10.1: Material Contract

Exhibit 10.3: Material Contract

Exhibit 10.4: Material Contract

Exhibit 10.5: Material Contract

Exhibit 10.6: Material Contract

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: 0001293971-22-000063
Submitted to the SEC: Mon Nov 07 2022 7:05:16 AM EST
Accepted by the SEC: Mon Nov 07 2022
Period: Friday, September 30, 2022
Industry: Biological Products No Disgnostic Substances