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Bluebird Bio, Inc. (BLUE) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2020

Bluebird Bio, Inc.

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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.”

RECENT HIGHLIGHTS

COMPANY

•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-K Annual 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-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Cover
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Operations And Comprehensive Loss (Parenthetical)
Consolidated Statements Of Stockholders' Equity
Consolidated Statements Of Stockholders' Equity (Parenthetical)
401(K) Savings Plan
401(K) Savings Plan - Additional Information (Detail)
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)
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 (Detail)
Collaborative Arrangements - Summary Of Revenue Recognized Related To Research And Development Services (Detail)
Collaborative Arrangements - Summary Of Total Transaction Price (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Non-Cancelable Contractual Obligations (Detail)
Common Stock And Preferred Stock
Common Stock And Preferred Stock (Tables)
Common Stock And Preferred Stock - Additional Information (Detail)
Common Stock And Preferred Stock - Summary Of Future Issuance Of Common Stock Shares (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
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Components Of Deferred Tax Assets And Liabilities (Detail)
Income Taxes - Reconciliation Of Income Tax Provision (Benefit) (Detail)
Income Taxes - Reconciliation Of Unrecognized Tax Benefits (Detail)
Income Taxes - Schedule Of Components Of Loss Before Income Taxes (Detail)
Income Taxes - Summary Of Provision For (Benefit From) Income Taxes (Detail)
Intangible Assets
Intangible Assets (Tables)
Intangible Assets - Additional Information (Detail)
Intangible Assets - Schedule Of Finite-Lived Intangible Assets (Details)
Intangible Assets - Schedule Of Finite-Lived Intangible Assets, Future Amortization Expense (Details)
Leases
Leases (Tables)
Leases - Additional Information (Details)
Leases - Schedule Of Future Minimum Commitments Under Operating Leases (Details)
Leases - Summary Of Lease Costs And Other Information Pertaining To Operating Leases (Details)
Marketable Securities
Marketable Securities (Tables)
Marketable Securities - Additional Information (Detail)
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)
Restricted Cash
Restricted Cash (Tables)
Restricted Cash - Additional Information (Detail)
Restricted Cash - Schedule Of Collateralized Bank Account Of Financial Institution (Detail)
Royalty And Other Revenue
Royalty And Other Revenue - Additional Information (Detail)
Selected Quarterly Financial Data (Unaudited)
Selected Quarterly Financial Data (Unaudited) (Tables)
Selected Quarterly Financial Data (Unaudited) - Quarterly Financial Information (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Detail)
Stock-Based Compensation - Assumptions Used For The Black-Scholes Option-Pricing Model To Determine The Per Share Weighted Average Fair Value For Options Granted (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 (Details)
Summary Of Significant Accounting Policies And Basis Of Presentation
Summary Of Significant Accounting Policies And Basis Of Presentation (Policies)
Summary Of Significant Accounting Policies And Basis Of Presentation (Tables)
Summary Of Significant Accounting Policies And Basis Of Presentation - Additional Information (Detail)
Summary Of Significant Accounting Policies And Basis Of Presentation - Estimated Useful Lives Of Assets (Detail)
Ticker: BLUE
CIK: 1293971
Form Type: 10-K Annual Report
Accession Number: 0001293971-21-000013
Submitted to the SEC: Tue Feb 23 2021 4:12:35 PM EST
Accepted by the SEC: Tue Feb 23 2021
Period: Thursday, December 31, 2020
Industry: Biological Products No Disgnostic Substances

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