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Bluebird Bio, Inc. (BLUE) SEC Filing 10-Q Quarterly report for the period ending Wednesday, September 30, 2020

Bluebird Bio, Inc.

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CIK: 1293971 Ticker: BLUE


Exhibit 99.1

bluebird bio Provides Operational and Business Update and Reports First Quarter 2020 Financial Results

- Alignment with FDA on an accelerated regulatory path for LentiGlobin for sickle cell disease based on HGB-206 study with targeted submission in 2H 2021 -
- Completed submission with Bristol Myers Squibb of Biologics License Application (BLA) for anti-BCMA CAR T cell therapy idecabtagene vicleucel (ide-cel, bb2121) to FDA -
- Amended BMS collaboration including $200 million monetization for ex-U.S. milestone and royalty revenue from idecabtagene vicleucel (ide-cel, bb2121) and bb21217 -
- Revised Operating Plan achieves cash savings of over $500 million through 2022 -
- Company extends cash runway into 2022 -
- Company to host conference call today, May 11, 2020 at 8:00AM ET -

CAMBRIDGE, Mass. – May 11, 2020 – bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the first quarter ended March 31, 2020 and provided an operational update.

“We remain grounded in our core values and priorities: our patients, our people, our community and our business,” said Nick Leschly, chief bluebird. “This quarter, we successfully submitted the ide-cel BLA with our partners at BMS and I am pleased to announce today that we have alignment with FDA on our clinical data package and filing path for LentiGlobin for sickle cell disease, which accelerates our planned base case filing timeline into 2021. Additionally, we are amending our co-promotion/co-development agreement with BMS to enable both companies to focus their efforts on efficient commercialization of ide-cel and generate non-dilutive capital for our business. Lastly, after a rigorous review of all operational plans to reflect COVID-19 uncertainties and recent program shifts, we have prioritized our core four programs to drive ide-cel launch and three filings in 2021 for CALD, TDT and SCD and continue to drive forward high potential pipeline assets. This prioritization effort and operational review has led to significant efficiencies and spend reduction across our company and will extend our cash runway into 2022. The fundamentals of our business remain sound and our newly revised operating plan enables us to execute on the 2022 vision while putting us on a path towards financial sustainability. Our team remains excited and committed to our mission with the belief we will emerge from a very tough period in history stronger than ever to deliver for patients. Thank you birds!”

SCD REGULATORY PATH

Today, bluebird bio announced general agreement with FDA that the clinical data package required to support a BLA submission for LentiGlobin™ for sickle cell disease (SCD) will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint and at least 18 months of follow-up post drug product infusion. Globin response will be used as a key secondary endpoint. The company anticipates additional guidance from FDA regarding the commercial manufacturing process, including suspension lentiviral vector. The company is planning to seek an accelerated approval and expects to submit the U.S. Biologics Licensing Application (BLA) for sickle cell disease in the second half of 2021. bluebird bio plans to present updated data from the HGB-206 study at the European Hematology Association (EHA) Annual Meeting.


The following information was filed by Bluebird Bio, Inc. (BLUE) on Monday, May 11, 2020 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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Bluebird Bio, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2020 10-K Annual Report includes:

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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 (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 (Parenthetical)
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 - 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 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 - Narrative (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
Leases
Leases - Narrative (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 - Narrative (Detail)
Property, Plant And Equipment, Net - Summary Of Property, Plant And Equipment Net (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

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 32.1: Section 1350 Certification
Ticker: BLUE
CIK: 1293971
Form Type: 10-Q Quarterly Report
Accession Number: 0001293971-20-000066
Submitted to the SEC: Wed Nov 04 2020 4:12:21 PM EST
Accepted by the SEC: Wed Nov 04 2020
Period: Wednesday, September 30, 2020
Industry: Biological Products No Disgnostic Substances

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