Actions intended to reduce cash operating
expenses by approximately 20%
Management team to host conference call today,
September 24 at 8:00 am ET
Following a comprehensive review of its operations, bluebird
bio, Inc. (Nasdaq: BLUE) today announced that the Company is
implementing a restructuring intended to optimize the Company’s
cost structure and enable quarterly cash flow break-even in the
second half of 2025. The restructuring is expected to result in a
20% reduction in cash operating expenses when fully realized in Q3
2025, compared to the prior reporting period. The initiative
includes a reduction in the Company’s workforce of approximately
25%. The Company’s cash flow break-even target assumes scaling to
approximately 40 drug product deliveries per quarter, realizing the
20% reduction in cash operating expenses, and obtaining additional
cash resources to extend the Company’s cash runway.
“bluebird has set the standard for gene therapy for more than a
decade, and we continue to lead the field in the commercial setting
with three potentially transformative FDA-approved therapies,” said
Andrew Obenshain, chief executive officer, bluebird bio. “Today we
are taking decisive action designed to optimize our cost structure
and position the company to attract the additional capital required
to unlock the significant commercial opportunity before us. The
decision to reduce our workforce in support of a more focused set
of priorities was made following a detailed review of the needs and
capabilities of our organization, and we are grateful to every
bluebird who has helped realize our founding vision of making gene
therapy a reality for patients and families impacted by severe
genetic diseases.”
As part of the restructuring, bluebird plans to further sharpen
its focus on the ongoing commercial launches of LYFGENIA, ZYNTEGLO
and SKYSONA to enable continued launch acceleration while the
Company evaluates opportunities to increase its cash resources.
Year-to-date, there have been 41 patient starts across bluebird’s
portfolio, up from 27 reported in mid-August. bluebird anticipates
approximately 40 patient starts in Q4 2024.
Investor Conference Call Information
bluebird bio will host a call for analysts and investors today,
September 24, 2024 at 8:00 am ET. To access the live conference
call via telephone, please register at this link to receive a dial
in number and unique PIN.
To access the live webcast of bluebird’s presentation, please
visit the “Events & Presentations” page within the Investors
& Media section of the bluebird website at
http://investor.bluebirdbio.com. A replay of the webcast will be
available on the bluebird website for 90 days following the
event.
About bluebird bio, Inc.
bluebird bio is pursuing curative gene therapies to give
patients and their families more bluebird days.
Founded in 2010, bluebird has been setting the standard for gene
therapy for more than a decade—first as a scientific pioneer and
now as a commercial leader. bluebird has an unrivaled track record
in bringing the promise of gene therapy out of clinical studies and
into the real-world setting, having secured FDA approvals for three
therapies in under two years. Today, we are proving and scaling the
commercial model for gene therapy and delivering innovative
solutions for access to patients, providers, and payers.
With a dedicated focus on severe genetic diseases, bluebird has
the largest and deepest ex-vivo gene therapy data set in the field,
with industry-leading programs for sickle cell disease,
β-thalassemia and cerebral adrenoleukodystrophy. 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.
bluebird continues to forge new paths as a standalone commercial
gene therapy company, 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.
For more information, visit bluebirdbio.com or follow us
on social media at @bluebirdbio, LinkedIn,
Instagram and YouTube.
bluebird bio Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements that are not statements of historical facts
are, or may be deemed to be, forward-looking statements, such as
statements regarding the objectives and anticipated results of
bluebird’s restructuring, including the Company’s ability to
optimize its cost structure and enable cash flow break-even in the
second half of 2025 and reduce cash operating expenses by
approximately 20%; bluebird’s ability to extend its cash runway by
obtaining additional cash resources; and bluebird’s
commercialization plans, including the anticipated number of drug
product deliveries per quarter, and the number of anticipated
patient starts. Such forward-looking statements are based on
historical performance and current expectations and projections
about bluebird’s future goals, plans and objectives and involve
inherent risks, assumptions and uncertainties, including internal
or external factors that could delay, divert or change any of them
in the next several years, that are difficult to predict, may be
beyond bluebird’s control and could cause bluebird’s future goals,
plans and objectives to differ materially from those expressed in,
or implied by, the statements. No forward-looking statement can be
guaranteed. Forward-looking statements in this press release should
be evaluated together with the many risks and uncertainties that
affect bluebird bio’s business, particularly those identified in
the risk factors discussion in bluebird bio’s Annual Report on Form
10-K for the year ended December 31, 2023, as updated by its
subsequent Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other filings with the Securities and Exchange Commission.
These risks and uncertainties include, but are not limited to:
delays and challenges in bluebird’s commercialization and
manufacturing of its products; the internal and external costs
required for bluebird’s ongoing and planned activities, and the
resulting impact on expense and use of cash, has been, and may in
the future be, higher than expected, which has caused bluebird, and
may in the future cause bluebird, to use cash more quickly than it
expects or change or curtail some of its plans or both; substantial
doubt exists regarding bluebird’s ability to continue as a going
concern; bluebird’s expectations as to expenses, cash usage and
cash needs may prove not to be correct for other reasons such as
changes in plans or actual events being different than bluebird’s
assumptions; the risk that additional funding may not be available
on acceptable terms, or at all; risks related to bluebird's loan
agreement, including the risk that operating restrictions could
adversely affect bluebird's ability to conduct its business, the
risk that bluebird will not achieve milestones required to access
future tranches under the agreement, and the risk that bluebird
will fail to comply with covenants under the agreement, including
with respect to required cash and revenue levels, which could
result in an event of default; the risk that the efficacy and
safety results from bluebird’s prior and ongoing clinical trials
will not continue or be seen in the commercial context; the risk
that the QTCs experience delays in their ability to enroll or treat
patients; the risk that bluebird experiences delays in establishing
operational readiness across its supply chain; the risk that there
is not sufficient patient demand or payer reimbursement to support
continued commercialization of the Company’s therapies; the risk of
insertional oncogenic or other safety events associated with
lentiviral vector, drug product, or myeloablation, including the
risk of hematologic malignancy; the risk that bluebird’s products,
including LYFGENIA, will not be successfully commercialized; and
risks related to compliance with Nasdaq continued listing
requirements. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, bluebird bio undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
changed circumstances or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240924257891/en/
Investors: Courtney O’Leary, 978-621-7347
coleary@bluebirdbio.com
or
Media: Jess Rowlands, 857-299-6103
jess.rowlands@bluebirdbio.com
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