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Bluebird Bio, Inc. (BLUE) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

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Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE



Exhibit 99.1

bluebird bio Reports Fourth Quarter and Full Year 2021 Financial Results, Highlights Operational Progress and Provides Corporate Update

- The Company’s first two gene therapies, beti-cel for β-thalassemia and eli-cel for cerebral adrenoleukodystrophy, under review by the FDA -

- lovo-cel BLA submission for sickle cell disease remains on track for Q1 2023 -

- Ended year with $442M in restricted cash, cash and cash equivalents and marketable securities -

CAMBRIDGE, Mass. March 4, 2022 – bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2021, shared recent operational progress, and provided a corporate update.

“2022 is set up to be a landmark year for bluebird bio, with LVV gene therapies for β-thalassemia and cerebral adrenoleukodystrophy under review by the U.S. Food and Drug Administration (FDA) and plans to submit a Biologics License Application (BLA) for lovo-cel for sickle cell disease (SCD) early next year," said Andrew Obenshain, CEO, bluebird bio. "Underscoring these significant milestones is a continued focus on commercialization and financial discipline to enable the delivery of these transformative therapies to patients and their families.”

RECENT HIGHLIGHTS

LOVO-CEL
UPDATE ON PARTIAL CLINICAL HOLD FOR PATIENTS UNDER THE AGE OF 18 – Today, bluebird bio provided an update on the FDA’s partial clinical hold for the lovotibeglogene autotemcel (lovo-cel) gene therapy clinical program for patients under the age of 18 with SCD. As previously communicated, in January 2022, bluebird bio received questions from the FDA related to the partial clinical hold. Following review of the questions from the FDA and an assessment of the timeline for manufacturing drug product lots and collecting analytical comparability data in the HGB-210 study, bluebird bio is reaffirming plans to submit the BLA for lovo-cel in Q1 2023. The Company continues to work with regulators to resume treating patients under the age of 18. In the meantime, the Company is collecting comparability data from drug product lots manufactured for adult patients in the HGB-210 study. As previously communicated, bluebird bio has treated all patients in HGB-206 Group C who will form the primary basis of efficacy for BLA submission, with the demonstration of analytical comparability and validation of the Company’s commercial manufacturing process as the key remaining actions prior to submission of the planned BLA.

HGB-206 FINAL INFUSION – Today, bluebird bio announced the completion of the final patient infusion in the HGB-206 study, the ongoing Phase 1/2 open-label study designed to evaluate the efficacy and safety of lovo-cel for sickle cell disease. A total of 45 patients have been treated with lovo-cel in the HGB-206 study across three treatment cohorts: Groups A (n=7), B (n=2) and C (n=36).

DATA AT ASH AND PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE On December 12, 2021, at the 63rd American Society of Hematology (ASH) Annual Meeting, bluebird bio presented new data showing a complete elimination of severe vaso-occlusive events (VOEs) through up to 36 months of follow-up in 25 patients who had a history of at least four severe


The following information was filed by Bluebird Bio, Inc. (BLUE) on Friday, March 4, 2022 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

Audit Information
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 - Narrative (Details)
Accrued Expenses And Other Current Liabilities - Summary Of Accrued Expenses And Other Current Liabilities (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Schedule Of Non-Cancelable Contractual Obligations (Detail)
Description Of The Business
Description Of The Business - Additional Information (Detail)
Discontinued Operations
Discontinued Operations (Tables)
Discontinued Operations - Assets, Liabilities And Stockholders' Equity (Details)
Discontinued Operations - Narrative (Details)
Discontinued Operations - Revenue And Expenses (Details)
Discontinued Operations - Significant Non-Cash Items And Capital Expenditures (Details)
Equity
Equity (Tables)
Equity - Narrative (Detail)
Equity - Summary Of Future Issuance Of Common Stock Shares (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 - Components Of Deferred Tax Assets And Liabilities (Detail)
Income Taxes - Narrative (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 - Narrative (Detail)
Intangible Assets - Schedule Of Finite-Lived Intangible Assets (Details)
Inventory
Inventory (Details)
Inventory (Tables)
Leases
Leases (Tables)
Leases - Narrative (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 - Narrative (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 - Narrative (Detail)
Property, Plant And Equipment, Net - Summary Of Property, Plant And Equipment Net (Detail)
Reduction In Workforce
Reduction In Workforce (Tables)
Reduction In Workforce - Accrued Liabilities Activity (Details)
Reduction In Workforce - Narrative (Details)
Restricted Cash
Restricted Cash (Tables)
Restricted Cash - Narrative (Detail)
Restricted Cash - Schedule Of Collateralized Bank Account Of Financial Institution (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 - 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 - 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)
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 - Estimated Useful Lives Of Assets (Detail)
Summary Of Significant Accounting Policies And Basis Of Presentation - Narrative (Detail)
Ticker: BLUE
CIK: 1293971
Form Type: 10-K Annual Report
Accession Number: 0001293971-22-000016
Submitted to the SEC: Fri Mar 04 2022 4:35:13 PM EST
Accepted by the SEC: Fri Mar 04 2022
Period: Friday, December 31, 2021
Industry: Biological Products No Disgnostic Substances

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