- First patient start (cell collection) for
LYFGENIA completed –
- 15 patient starts to date in 2024 (11
ZYNTEGLO, 3 SKYSONA, 1 LYFGENIA); 85 to 105 patient starts
anticipated across the portfolio in 2024 -
- First quarter 2024 net revenue of $18.6
million -
- Management to host conference call today, May
9, 2024 at 8:00 am ET -
bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the
“Company”) today reported first quarter results and business
highlights for the quarter ended March 31, 2024, including recent
commercial and operational progress.
“bluebird has built a solid commercial gene therapy foundation,
with an unparalleled network of qualified treatment centers (QTCs),
proven access and reimbursement for patients, and demonstrated
demand from both patients and providers,” said Andrew Obenshain,
chief executive officer, bluebird bio. “Following the completion of
the first LYFGENIA patient start earlier this month, and with the
continued momentum behind our ongoing launches, we believe we are
poised for accelerated growth through the remainder of 2024.”
COMMERCIAL LAUNCH
UPDATES
Continued commercial momentum for LYFGENIA™
(lovotibeglogene autotemcel), ZYNTEGLO™ (betibeglogene
autotemcel) and SKYSONA™ (elivaldogene autotemcel)
- First LYFGENIA patient start completed in May 2024.
- 14 patient starts completed for ZYNTEGLO and SKYSONA since the
beginning of 2024 (11 ZYNTEGLO, 3 SKYSONA).
Validated access and reimbursement strategy is driving
favorable coverage landscape
- Successfully confirmed prior authorization approval for
commercial and Medicaid-insured patients for LYFGENIA.
- Multiple outcomes-based agreements in place for LYFGENIA with
national commercial payer organizations; published coverage
policies are in place for more than 200 million U.S. lives.
- Discussions ongoing with Medicaid agencies representing 80% of
Medicaid-insured individuals with sickle cell disease in the
U.S.
- Timely access to ZYNTEGLO and SKYSONA has continued, with zero
ultimate denials for either therapy across both Medicaid and
commercial payers.
Substantial QTC footprint established
- bluebird has activated 64 QTCs for LYFGENIA and ZYNTEGLO
(defined as a signed MSA).
- Six centers are also activated to administer SKYSONA for
patients with cerebral adrenoleukodystrophy (CALD).
2024 GUIDANCE
- The Company anticipates 85 to 105 patient starts (cell
collections) combined across all three of its FDA approved
therapies (LYFGENIA, ZYNTEGLO, SKYSONA) in 2024. Consistent with
previous quarters, bluebird plans to provide quarterly updates on
patient starts for each of its therapies.
- Gross-to-net discounts across all three products are expected
to be in the range of 20% to 25% of gross revenue in 2024 and will
fluctuate based on product and payer mix, as well as utilization of
outcomes-based agreements for LYFGENIA and ZYNTEGLO.
- Based on projected timelines from cell collection to infusion,
the Company anticipates recognizing revenue from its first infusion
of LYFGENIA in the third quarter of 2024.
FIRST QUARTER FINANCIAL
HIGHLIGHTS
- Cash Position: The Company’s cash, cash equivalents and
restricted cash balance was approximately $264 million, including
restricted cash of approximately $52 million, as of March 31, 2024
Based on current business plans, which assumes the Company’s
ability to achieve certain commercial revenue targets, bluebird
expects its cash and cash equivalents, excluding restricted cash
and assuming the remaining two tranches totaling $50 million in
proceeds from its term loan facility with Hercules Capital are
executed, will be sufficient to meet bluebird’s planned operating
expenses and capital expenditure requirements through Q1 2026.
- Revenue, net: Total revenue, net was $18.6 million for
the three months ended March 31, 2024, compared to $2.4 million for
the three months ended March 31, 2023. The increase of $16.2
million was due to increased ZYNTEGLO product revenue.
On March 26, 2024, bluebird announced that it will restate its
consolidated financial statements as of and for the year ended
December 31, 2022, and for each of the first three quarters of 2022
and 2023 in its Annual Report on Form 10-K for the year ended
December 31, 2023 (the “2023 Form 10-K"). The restatements relate
to the identification of embedded leases and the treatment of
non-lease components contained in lease agreements. The restatement
is not expected to impact the Company’s cash position or revenue.
As a result of the restatement, the Company is delayed in filing
its 2023 Form 10-K and its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2024 (the “Q1 2024 Form 10-Q"). The Company
is continuing to work expeditiously to complete these filings.
The financial results included in this press release represent
the most current information available to the Company’s management.
The Company expects that its actual results to be reported in its
Q1 2024 Form 10-Q will not differ materially from the results
included herein, however, these results are subject to change
following the completion of the Company’s financial close
procedures and the review of its consolidated financial statements
for the quarter ended March 31, 2024.
CONFERENCE CALL DETAILS
bluebird will hold a conference call to discuss its first
quarter 2024 results and business updates today, Thursday, May 9,
2024, at 8:00 am ET.
To participate in the conference call, please dial +1 (800)
715-9871 (U.S. and Canada) and ask to be joined into the bluebird
call or provide the Conference ID 9768329.
The live webcast of the call may be accessed by visiting 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.
bluebird bio, LYFGENIA, ZYNTEGLO and SKYSONA are registered
trademarks of bluebird bio, Inc. All rights reserved.
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 number of anticipated patient starts
across bluebird’s portfolio of therapies, the Company’s anticipated
cash runway, the Company’s expectations regarding its ability to
access future tranches of its term loan facility, the Company’s
expectations with respect to gross-to-net discounts for its
products and the commercialization of LYFGENIA, including without
limitation, the timing of revenue recognition, patient demand for
the therapy, bluebird’s ability to establish favorable coverage for
its therapies, including its ability to successfully partner with
payers, and expectations regarding the Company’s restatement of
certain historical financial statements and the timing for filing
of its 2023 Form 10-K and Q1 2024 Form 10-Q. 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, 2022, 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,
including our Prospectus Supplement, dated December 22, 2023. These
risks and uncertainties include, but are not limited to: delays and
challenges in bluebird’s commercialization and manufacturing of its
products, including challenges in manufacturing vector for ZYNTEGLO
and SKYSONA to meet current demand; 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; 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 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 bluebird is not able to activate
QTCs on the timeframe that it expects; 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 following approval to support
treatment in the commercial context; 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; and the risk that bluebird’s
products, including LYFGENIA, will not be successfully
commercialized. 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/20240509280117/en/
Investors & Media Investors: Courtney O’Leary,
978-621-7347 coleary@bluebirdbio.com Media: Jess Rowlands,
857-299-6103 jess.rowlands@bluebirdbio.com
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