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bluebird bio Reports Third Quarter Financial Results and Recent Operational Progress

– Company separation completed on November 4, 2021 –

CAMBRIDGE, Mass.–(BUSINESS WIRE)–bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the third quarter ended September 30, 2021.

“This quarter was about preparing for the completion of the separation of bluebird bio and 2seventy bio and realizing the value of two independent companies,” said Andrew Obenshain, chief executive officer, bluebird bio. “Notably this quarter, we secured additional capital through the close of a private financing and completion of the sale of our manufacturing facility in North Carolina and continued to make meaningful progress with our product pipeline, including filing the US biologics licensing application for beti-cel for beta-thalassemia. I am excited for what lies ahead for both bluebird and 2seventy bio, and the impact that both companies will have for patients and their families.”

BUSINESS SEPARATION RECENT HIGHLIGHTS

RECENT HIGHLIGHTS

β-THALASSEMIA

COMPANY

UPCOMING ANTICIPATED MILESTONES

THIRD QUARTER 2021 FINANCIAL RESULTS

About bluebird bio, Inc.

bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days.

With a dedicated focus on severe genetic diseases, bluebird has industry-leading clinical programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy and is advancing research to apply new technologies to these and other diseases. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.

Founded in 2010, bluebird has the largest and deepest ex-vivo gene therapy data set in the world—setting the standard for the industry. Today, bluebird continues to forge new paths, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds.

ZYNTEGLO, SKYSONA, LentiGlobin, and bluebird bio are trademarks of bluebird bio, Inc.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s financial condition, results of operations, as well as statements regarding the Company’s plans and expectations for operations including its wind down of operations in Europe; the Company’s plans and expectations for the timing of BLA submissions; and the impact of the separation of 2seventy bio. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company may not be able to execute an orderly wind down of European operations with the timing or at a cost that we anticipated; the risk that additional insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time; the risk that the FDA may impose a clinical hold on additional programs utilizing lentiviral vectors; the risk that we may not be able to address the FDA’s concerns regarding eli-cel quickly or at all; the risk that the FDA may require additional information, testing, or monitoring that results in a delay to our regulatory submission plans including our BLAs for beti-cel and eli-cel; the risks that we may not achieve the expected benefits of a separation, and a separation could harm our business, results of operations and financial condition; dedicated financial and/or strategic funding sources may not be available on favorable terms; the risk that we are unable to realize the intended benefits of resizing and reshaping our workforce; the COVID-19 pandemic and resulting economic conditions will have a greater impact on the company’s operations and plans than anticipated; that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials; the risk that the current or planned clinical trials of our product candidates will be insufficient to support regulatory submissions or marketing approval in the United States; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

bluebird bio, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except per share data)

 

 

For the three months ended September 30,

 

For the nine months ended September 30,

 

2021

 

2020

 

2021

 

2020

Revenue:

 

 

 

 

 

 

 

Service revenue

$

6,312

 

 

$

13,352

 

 

$

17,544

 

 

$

108,542

 

Collaborative arrangement revenue

14,831

 

 

2,422

 

 

18,020

 

 

114,398

 

Royalty and other revenue

1,534

 

 

3,499

 

 

7,379

 

 

17,086

 

Total revenues

22,677

 

 

19,273

 

 

42,943

 

 

240,026

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

131,427

 

 

140,431

 

 

429,614

 

 

450,862

 

Selling, general and administrative

68,277

 

 

68,046

 

 

229,708

 

 

209,922

 

Share of collaboration loss

 

 

 

 

10,071

 

 

 

Cost of royalty and other revenue

19,704

 

 

1,318

 

 

37,286

 

 

3,897

 

Restructuring expense

20,175

 

 

 

 

24,800

 

 

 

Change in fair value of contingent consideration

48

 

 

(828

)

 

464

 

 

(5,591

)

Total operating expenses

239,631

 

 

208,967

 

 

731,943

 

 

659,090

 

Loss from operations

(216,954

)

 

(189,694

)

 

(689,000

)

 

(419,064

)

Interest income, net

319

 

 

1,964

 

 

1,468

 

 

10,258

 

Other income (expense), net

(294

)

 

(6,686

)

 

23,375

 

 

(9,582

)

Loss before income taxes

(216,929

)

 

(194,416

)

 

(664,157

)

 

(418,388

)

Income tax benefit (expense)

113

 

 

(329

)

 

(169

)

 

(433

)

Net loss

$

(216,816

)

 

$

(194,745

)

 

$

(664,326

)

 

$

(418,821

)

Net loss per share – basic and diluted:

$

(3.16

)

 

$

(2.94

)

 

$

(9.81

)

 

$

(6.89

)

Weighted-average number of common shares used in computing net loss per share – basic and diluted:

68,621

 

 

66,251

 

 

67,701

 

 

60,762

 

bluebird bio, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands, except per share data)

(unaudited)

 

 

As of

September 30,

2021

 

As of

December 31,

2020

Cash, cash equivalents and marketable securities

$

970,730

$

1,274,142

Total assets

$

1,339,644

 

 

$

1,781,252

 

Total liabilities

$

469,117

 

 

$

426,196

 

Total stockholders’ equity

$

870,527

 

 

$

1,355,056

 

 

Contacts

Investors & Media

For bluebird bio
Investors:

Courtney O’Leary, 978-621-7347

coleary@bluebirdbio.com

Media:

Sarah Alspach, 857-299-6198

sarah.alspach@bluebirdbio.com

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