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Bluebird Bio, Inc. (BLUE) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022

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BLUE Quarterly Reports

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE
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Exhibit 99.1

bluebird bio Reports Third Quarter 2022 Financial Results and Highlights Operational Progress

– Commercial launch of ZYNTEGLO® (betibeglogene autotemcel) underway; on track for first apheresis in the fourth quarter of 2022 –

– Chris Krawtschuk appointed chief financial officer –

– Ended quarter with $186M in cash and cash equivalents, marketable securities and restricted cash –

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 betathalassemia 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 Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses And Other Current Liabilities
Accrued Expenses And Other Current Liabilities (Tables)
Accrued Expenses And Other Current Liabilities - Schedule Of Accrued Expenses And Other Current Liabilities (Details)
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies (Detail)
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies (Policies)
Commitments And Contingencies
Commitments And Contingencies (Detail)
Description Of The Business
Description Of The Business (Detail)
Discontinued Operations
Discontinued Operations (Tables)
Discontinued Operations - Narrative (Details)
Discontinued Operations - Revenue And Expenses (Details)
Discontinued Operations - Significant Non-Cash Items And Capital Expenditures (Details)
Equity
Equity (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Narrative (Detail)
Fair Value Measurements - Recorded Amount Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Fair Value Measurements - Schedule Of Unrealized Loss On Investments (Details)
Income Taxes
Leases
Leases - Embedded Operating Leases Narrative (Details)
Leases - Narrative (Details)
Marketable Securities
Marketable Securities (Detail)
Marketable Securities (Tables)
Net Loss Per Share
Net Loss Per Share (Detail)
Net Loss Per Share (Tables)
Property, Plant And Equipment, Net
Property, Plant And Equipment, Net (Tables)
Property, Plant And Equipment, Net - Summary Of Property, Plant And Equipment Net (Detail)
Restructuring
Restructuring (Tables)
Restructuring - Accrued Liabilities Activity (Details)
Restructuring - Narrative (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Narrative (Detail)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Expense By Classification (Detail)
Stock-Based Compensation - Summary Of Restricted Stock Units (Detail)
Stock-Based Compensation - Summary Of Stock Option Activity Under Plan (Detail)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense By Award Type (Detail)
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

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