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

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE

 

Exhibit 99.1

 

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

 

- Continued progress towards 2022 vision of four marketed gene and cell therapy products with robust development pipeline -

- ZYNTEGLO commercial launch advancing with European Medicines Agency approval of refined commercial manufacturing process -

- Ended quarter with $1.41 billion in cash, cash equivalents and marketable securities -

 

CAMBRIDGE, Mass. October 31, 2019 – bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the third quarter ended September 30, 2019.

 

“During the third quarter we advanced our country-by-country launch plans in Europe and, with the recent approval of the commercial drug product manufacturing specifications for ZYNTEGLO, we moved one step closer to our goal of treating patients suffering from TDT in early 2020,” said Nick Leschly, chief bluebird. “Also this quarter, we presented updated data from the Phase 2/3 Starbeam study in patients with CALD. To report that patients continued to be free of MFDs at up to five years of follow-up is something we’re tremendously proud to do for these families, and we look forward to advancing that program in the regulatory process next year. Looking ahead, we plan to provide clinical updates for ZYNTEGLO and across the rest of our portfolio, including LentiGlobin in sickle cell disease, bb21217 in multiple myeloma, and from our registration-enabling KarMMa study of ide-cel in patients with multiple myeloma by the end of this year. I’d like to thank all the bluebirds around the globe for their tireless focus on doing the right thing for our patients – we’ve seen amazing progress thus far in 2019 and I look forward to ending the year on a strong note.”

 

Recent Highlights:

 

TDT

 

ZYNTEGLO COMMERCIAL READINESS – In October, bluebird bio announced that the European Medicines Agency (EMA) approved the refined commercial drug product manufacturing specifications for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. With this update, apceth is in the final stages of preparing to manufacture ZYNTEGLO for commercial use. The company continues to proceed with discussions on value-based payment agreements and Qualified Treatment Center contracts and expects to treat the first commercial patient in early 2020.

 

CALD

 

 

DATA FROM STARBEAM STUDY (ALD-102) AND ALD-103 PRESENTED – At the 13th European Pediatric Neurology Society (EPNS) Congress in September 2019, bluebird bio presented new data from the clinical development program for its investigational studies of Lenti-D™ gene therapy in patients with cerebral adrenoleukodystrophy: updated data from the Phase 2/3

 


The following information was filed by Bluebird Bio, Inc. (BLUE) on Thursday, October 31, 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)

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: 0001564590-19-039179
Submitted to the SEC: Thu Oct 31 2019 12:48:35 PM EST
Accepted by the SEC: Thu Oct 31 2019
Period: Monday, September 30, 2019
Industry: Biological Products No Disgnostic Substances

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