Bluebird Bio, Inc. (BLUE) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE

Exhibit 99.1

bluebird bio Reports Fourth Quarter and Full Year 2020 Financial Results and Highlights Operational Progress

CAMBRIDGE, Mass. Feb. 23, 2021 – bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2020 and shared recent operational progress.

“For over ten years, bluebird bio has been pioneering gene therapies for patients with rare diseases and cancer, and our work continues with the analysis of the recent safety events identified in our HGB-206 study in patients with sickle cell disease. We have seen the transformative benefit of these therapies and are conducting a scientific and medical investigation to best inform our path forward on behalf of the patients we hope to serve with LentiGlobin,” said Nick Leschly, chief bluebird. “While this work is ongoing, we remain focused on the upcoming PDUFA action due date for ide-cel for multiple myeloma next month, the potential EU approval of eli-cel for CALD mid-year and the planned US filings for β-thalassemia and CALD later in the year. Through these challenges, we are keeping patients at the center and were very excited to reach a major milestone of the first commercial infusion of ZYNTEGLO in Germany earlier this month.”



CLINICAL HOLD OF PHASE 1/2 AND PHASE 3 STUDIES OF LENTIGLOBIN GENE THERAPY FOR SICKLE CELL DISEASE AND TEMPORARY SUSPENSION OF MARKETING OF ZYNTEGLO IN EUROPE – On February 16, 2021, bluebird bio announced that due to a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia and a SUSAR of myelodysplastic syndrome in our HGB-206 clinical study, the FDA has placed our clinical studies of LentiGlobin for SCD on clinical hold. We are investigating these events and plan to continue to work closely with the FDA in their review of these events. In addition, we are also engaged with the EMA in discussions regarding our proposed development plans for LentiGlobin for SCD in Europe. In light of these SUSARs, we have temporarily suspended marketing of ZYNTEGLO in Europe. Additionally, the EMA has paused the renewal procedure for ZYNTEGLO's conditional marketing authorization while the EMA's pharmacovigilance risk assessment committee reviews the risk-benefit assessment for ZYNTEGLO and determines whether any additional pharmacovigilance measures are necessary.

INTENT TO SEPARATE On January 11, 2021, bluebird bio announced its intent to separate its severe genetic disease and oncology businesses into two independent, publicly traded companies (bluebird bio and “Oncology Newco”). The separation is expected to be completed by year-end 2021 and it is anticipated that the spin out of Oncology Newco is to be tax-free to shareholders, subject to receipt of a favorable Internal Revenue Service (IRS) ruling.
Following the separation, bluebird bio intends to focus on delivery of its Core 3 therapies in β-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease, expand access and reimbursement for our commercial product, ZYNTEGLO, in Europe and continue to explore innovative tools and technologies to ultimately bring these transformative medicines to more patients.

The following information was filed by Bluebird Bio, Inc. (BLUE) on Tuesday, February 23, 2021 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.

View differences made from one quarter to another to evaluate Bluebird Bio, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Bluebird Bio, Inc..


Assess how Bluebird Bio, Inc.'s management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Bluebird Bio, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors


SEC Filing Tools


Learn More
Bullish Bearish Neutral
Filter Sentiment:
Filter Category:
Filter Subcategory:
Cash Flow
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 (Parenthetical)
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Parenthetical)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses And Other Current Liabilities
Accrued Expenses And Other Current Liabilities (Details)
Accrued Expenses And Other Current Liabilities (Tables)
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies (Policies)
Basis Of Presentation, Principles Of Consolidation And Significant Accounting Policies - Additional Information (Detail)
Collaborative Arrangements
Collaborative Arrangements (Tables)
Collaborative Arrangements - Changes In Balances Of Company's Receivables And Contract Liabilities (Detail)
Collaborative Arrangements - Narrative (Detail)
Collaborative Arrangements - Summary Of Revenue Recognized Or Expense Incurred For Joint Ide-Cel Development Efforts Related To Combined Unit Of Accounting For Its License And Vector Manufacturing Of Ide-Cel (Detail)
Collaborative Arrangements - Summary Of Total Transaction Price, Allocation Of Total Transaction Price To Identified Performance Obligations Under Arrangement And Amount Of Transaction Price Unsatisfied (Detail)
Commitments And Contingencies
Commitments And Contingencies - Narrative (Detail)
Description Of The Business
Description Of The Business - Additional Information (Detail)
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
Inventory (Details)
Inventory (Tables)
Leases - Embedded Operating Leases Narrative (Details)
Marketable Securities
Marketable Securities (Tables)
Marketable Securities - Summary Of Marketable Securities Held (Detail)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Common Stock Equivalents Excluded From Calculation Of Diluted Net Loss Per Share (Detail)
Property, Plant And Equipment, Net
Property, Plant And Equipment, Net (Tables)
Property, Plant And Equipment, Net - Narrative (Detail)
Property, Plant And Equipment, Net - Summary Of Property, Plant And Equipment Net (Detail)
Royalty And Other Revenue
Royalty And Other Revenue - Additional Information (Detail)
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)

Material Contracts, Statements, Certifications & more

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

Ticker: BLUE
CIK: 1293971
Form Type: 10-Q Quarterly Report
Accession Number: 0001293971-21-000041
Submitted to the SEC: Wed May 05 2021 4:13:10 PM EST
Accepted by the SEC: Wed May 05 2021
Period: Wednesday, March 31, 2021
Industry: Biological Products No Disgnostic Substances

External Resources:
Stock Quote
Social Media

Bookmark the Permalink: