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Bluebird Bio, Inc. (BLUE) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, December 31, 2019

Bluebird Bio, Inc.

CIK: 1293971 Ticker: BLUE


Exhibit 99.1

bluebird bio Reports Fourth Quarter and Full Year 2019 Financial Results and Highlights Operational Progress

– First conditional approval of ZYNTEGLOTM (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia who do not have β00 genotype in Europe achieved in 2019; Germany launch underway –
– Announced positive top-line data from pivotal Phase 2 KarMMa study of ide-cel in relapsed and refractory multiple myeloma –
– Presented clinical data across studies of LentiGlobin gene therapy for β-thalassemia (betibeglogene autotemcel) and LentiGlobin gene therapy for sickle cell disease (SCD) and bb21217 in multiple myeloma at American Society of Hematology (ASH) Annual Meeting –
– Ended quarter with $1.24 billion in cash, cash equivalents and marketable securities –

CAMBRIDGE, Mass. February 18, 2020 – bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2019.

“2019 was truly a transformative year for bluebird, with our first commercial product now launched in Europe and exciting progress across our first four clinical programs and pipeline,” said Nick Leschly, chief bluebird. “Notably, our data in SCD continues to build, and at the ASH annual meeting in December we presented data that showed a 99% reduction in the annualized rate of vaso-occlusive crises (VOC) and acute chest syndrome (ACS) in HGB-206 Group C patients with history of VOCs and ACS who had at least six months follow-up. In β-thalassemia, the consistency with which patients who do not have a β00 genotype in our Northstar-2 (HGB-207) study are achieving transfusion independence is very encouraging – and we’re starting to see indications that we may be able to see similar outcomes with many patients with β00 genotypes as well in our Northstar-3 (HGB-212 study). These data put us in a strong position as we progress our European launch, currently underway in Germany. At the end of 2019, we also announced positive top-line data from the pivotal KarMMa study of ide-cel. We and our partners at BMS look forward to submitting these data to the FDA in the first half of this year. Amidst all of our progress in 2019, our birds demonstrated time and again their dedication to patients and ability to meet and learn from the many challenges we have faced along the way. I look forward to facing the challenges of 2020 with this amazing flock.”

Recent Highlights:

TRANSFUSION-DEPENDENT β-THALASSEMIA

LAUNCH IN GERMANY – In January 2020, bluebird bio announced the launch of ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene), a 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 in Germany. The company signed its first agreements with statutory health insurances utilizing bluebird’s innovative value-based payment model and providing coverage for ZYNTEGLO for up to 50% of patients in Germany, and the first qualified treatment center was established at University Hospital of Heidelberg to provide ZYNTEGLO to patients. The company anticipates treating the first commercial patient in the first half of 2020.




The following information was filed by Bluebird Bio, Inc. (BLUE) on Tuesday, February 18, 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-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 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 - 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
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)
License And Royalty Revenue
License And Royalty Revenue - Additional Information (Detail)
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)
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)
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: 0001293971-20-000007
Submitted to the SEC: Tue Feb 18 2020 4:15:12 PM EST
Accepted by the SEC: Tue Feb 18 2020
Period: Tuesday, December 31, 2019
Industry: Biological Products No Disgnostic Substances

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