Last10K.com

Bluebird Bio, Inc. (BLUE) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE

 

Exhibit 99.1

 

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

 

- Received positive opinion from CHMP 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 β00 genotype -

- Company hosting Analyst Day on May 9, 2019 focused on research and commercial strategies -

- Ended quarter with $1.73 billion in cash, cash equivalents and marketable securities -

 

CAMBRIDGE, Mass. – May 2, 2019bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the first quarter ended March 31, 2019.

 

“In the first quarter, we came one step closer to bringing ZYNTEGLO™, the first gene therapy for transfusion-dependent β-thalassemia (TDT), to patients with a positive opinion from the CHMP and potential approval in Europe anticipated in the second quarter,” said Nick Leschly, chief bluebird. “We look forward to providing more detail on our commercial plans and launch expectations at our upcoming Analyst Day, including how our initial country-by-country launch in TDT will lay the foundation for our future launches. Our Analyst Day will also delve into our progress toward our stated goals of 1-2 new INDs per year beginning in 2020, and a deep pipeline by 2022. While the research and commercial engines are revving, our clinical development programs continue to progress at full speed, with the next data from our programs in TDT and sickle cell disease (SCD) anticipated in mid-year, and studies in earlier lines of multiple myeloma adding to the robust ide-cel (bb2121) development plan. Our team of bluebirds and our partners have been working relentlessly to get us to this point – and we’re only just getting started on our journey to help patients and their families.”  

 

Recent Highlights

 

TDT

 

CHMP POSITIVE OPINION – In March 2019, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization for ZYNTEGLO™ (autologous CD34+ cells encoding β A-T87Q-globin gene), 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. If approved, ZYNTEGLO, formerly referred to as LentiGlobin™ for TDT, will be the first commercially available gene therapy to treat TDT. The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to grant marketing authorization for ZYNTEGLO in the European Union (EU).

 

1

 


The following information was filed by Bluebird Bio, Inc. (BLUE) on Friday, May 3, 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.

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..

Continue

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 2019 10-K Annual Report includes:

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

Continue

SEC Filing Tools

Rating

Learn More
Bullish Bearish Neutral
Filter Sentiment:
All
Positive
Negative
Filter Category:
All
Financial
Legal
Revenue
Other
Filter Subcategory:
All
Expense
Geography
Product
Other
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 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)
Subsequent Events
Subsequent Events - Additional Information (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: 0001564590-19-015449
Submitted to the SEC: Thu May 02 2019 2:40:25 PM EST
Accepted by the SEC: Fri May 03 2019
Period: Sunday, March 31, 2019
Industry: Biological Products No Disgnostic Substances

External Resources:
Stock Quote
Social Media

Bookmark the Permalink:
https://last10k.com/sec-filings/blue/0001564590-19-015449.htm