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Bluebird Bio, Inc. (BLUE) SEC Filing 10-Q Quarterly report for the period ending Sunday, June 30, 2019

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE

 

Exhibit 99.1

 

bluebird bio Reports Second Quarter 2019 Financial Results and Highlights Operational Progress

 

– Received EU conditional marketing authorization for ZYNTEGLO® (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with transfusion dependent β-thalassemia (TDT) who do not have a β00 genotype –

– Presented data across LentiGlobin® for TDT and sickle cell disease (SCD) at 2019 European Hematology Association (EHA) Annual Congress –

– Ended quarter with $1.54 billion in cash, cash equivalents and marketable securities –

 

CAMBRIDGE, Mass. – August 1, 2019

bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the second quarter ended June 30, 2019.

 

“With the approval of our first gene therapy, bluebird bio has entered into an exciting, and potentially transformative time for patients and for the company. We are focused on getting our qualified treatment centers up and running in Europe, ensuring we are prepared to deliver ZYNTEGLO to patients, and advancing the implementation of our value and outcomes-based payment model,” said Nick Leschly, chief bluebird. “In the weeks since announcing our approval, we have been encouraged by our progress across these fronts and by the receptivity to our payment model from payers in our initial European launch markets. In the second half of the year, we are focused on executing our clinical studies as well as initiating new studies in sickle cell disease, multiple myeloma, and early stage oncology programs. I am incredibly grateful for our amazing and growing flock of bluebirds who are working to ensure that we do our best for patients every day.”  

 

Recent Highlights:

 

TDT

 

 

EU CONDITIONAL MARKETING AUTHORIZATION – In June 2019, bluebird bio announced that the European Commission (EC) granted conditional marketing authorization for ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene, known as LentiGlobin® for TDT), a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β00 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. The PRIME and Adaptive Pathway programs allowed for early and enhanced dialogue and accelerated assessment of ZYNTEGLO, which was completed on the shortest timetable for an advanced therapy medicinal product (ATMP) by the EMA to date. ZYNTEGLO is bluebird bio’s first gene therapy to gain regulatory approval. bluebird bio will continue the country-by-country reimbursement process to help ensure access to ZYNTEGLO for appropriate patients.

 

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The following information was filed by Bluebird Bio, Inc. (BLUE) on Thursday, August 1, 2019 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

Document And Entity Information
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)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited) (Parenthetical)
Accrued Expenses And Other Current Liabilities
Accrued Expenses And Other Current Liabilities (Tables)
Accrued Expenses And Other Current Liabilities - Summary Of Accrued Expenses And Other Current Liabilities (Detail)
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 - Additional Information (Detail)
Collaborative Arrangements - Changes In Balances Of Company's Receivables And Contract Liabilities (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 Revenue Recognized Or Revenue Adjustment Recorded Related To Research And Development Services (Detail)
Collaborative Arrangements - Summary Of Revenue Recognized Related To Research And Development Services (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 - Additional Information (Detail)
Description Of The Business
Description Of The Business - Additional Information (Detail)
Equity
Equity - Additional Information (Detail)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Detail)
Fair Value Measurements - Recorded Amount Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Fair Value Measurements - Roll-Forward Of Fair Value Of The Company's Contingent Consideration Obligations (Detail)
Income Taxes
Leases
Leases (Tables)
Leases - Additional Information (Detail)
Leases - Schedule Of Future Minimum Commitments Under Operating Leases (Detail)
Leases - Summary Of Lease Costs And Other Information Pertaining To Operating Leases (Detail)
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 - Additional Information (Detail)
Property, Plant And Equipment, Net - Summary Of Property, Plant And Equipment Net (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (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: 0001564590-19-028020
Submitted to the SEC: Thu Aug 01 2019 12:58:17 PM EST
Accepted by the SEC: Thu Aug 01 2019
Period: Sunday, June 30, 2019
Industry: Biological Products No Disgnostic Substances

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