- Cash runway through Q1 2026 following
announcement of a $175 million term loan facility with Hercules
Capital -
- 9 patient starts to date in 2024 (7 ZYNTEGLO,
2 SKYSONA); 85 to 105 patient starts anticipated across the
portfolio in 2024 -
- First government outcomes-based agreement for
sickle cell disease signed with Michigan Medicaid -
- 62 qualified treatment centers (QTCs)
activated -
- Full year 2023 revenue of $29.5 million with
$7.8 million generated in the fourth quarter -
- Management to host conference call today,
March 26, 2024 at 8:00 am ET -
bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the
“Company”) today reported fourth quarter and annual financial
results and business highlights for the year ended December 31,
2023, including recent commercial and operational progress.
“In 2023, bluebird established a validated, commercial gene
therapy strategy that brought ZYNTEGLO and SKYSONA to individuals
living with beta-thalassemia and cerebral adrenoleukodystrophy.
Building on that foundation, today we are positioned for robust
commercial uptake of LYFGENIA for sickle cell disease, with a
substantial QTC network in place, favorable Medicaid coverage being
established, and demonstrated strong patient demand,” said Andrew
Obenshain, chief executive officer, bluebird bio. “Our recent
agreement with Hercules Capital meaningfully extends our cash
runway, and further enables us to capitalize on our commercial head
start and bring our transformative gene therapies to patients and
their families. In 2024, we anticipate between 85 to 105 patient
starts across our three FDA approved therapies, laying the
foundation for strong revenue growth.”
RECENT COMPANY
HIGHLIGHTS
Up to $175 million Debt Financing with Hercules
Capital
- On March 18, 2024, bluebird announced that it had entered into
a five-year term loan facility with Hercules Capital. Under the
terms of the agreement, the Company may draw up to $175 million,
available in four tranches. The first tranche of $75 million was
drawn at closing. The Company may draw upon two additional tranches
of $25 million each, subject to satisfaction of certain conditions,
including achievement of commercial milestones. The facility also
provides for a fourth tranche of $50 million, available at the
lender’s discretion.
- Based on launch estimates and current business plans, and
assuming three tranches totaling $125 million are executed, the
transaction is projected to extend the Company’s cash runway
through Q1 2026.
COMMERCIAL LAUNCH
UPDATES
Strong patient uptake across portfolio
- First LYFGENIA patient start imminent; multiple patients
enrolled and preparing for treatment across QTC network.
- Continued strong, linear growth for ZYNTEGLO with 7 patient
starts since the beginning of 2024, in addition to 20 patient
starts completed for ZYNTEGLO in 2023.
- Completed 2 patient starts for SKYSONA since the beginning of
2024, in addition to 6 patient starts completed for SKYSONA in
2023.
Validated access and reimbursement strategy is driving
favorable coverage landscape
- In the first quarter of 2024, bluebird signed its first
Medicaid outcomes-based agreement for LYFGENIA with the state of
Michigan.
- In addition to the Medicaid outcomes-based agreement, bluebird
has signed four outcomes-based agreements for LYFGENIA with
national commercial payer organizations and published coverage
policies cover more than 200 million U.S. lives.
- Discussions are ongoing with more than 15 Medicaid agencies
representing 80% of Medicaid-insured individuals with sickle cell
disease in the U.S. and the Company is engaged with the Center for
Medicare and Medicaid Innovation (CMMI) on its Cell and Gene
Therapy Access Model demonstration.
- 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 62 QTCs for ZYNTEGLO (defined as a
signed MSA); capitalizing on launch synergies, 49 centers are
already receiving referrals for LYFGENIA.
- Five centers are also activated to administer SKYSONA for
patients with cerebral adrenoleukodystrophy (CALD).
- The Company anticipates continued QTC network expansion across
its portfolio in 2024.
LOVO-CEL CLINICAL TRIAL
UPDATE
- Enrollment is ongoing for the HGB-210 study evaluating lovo-cel
for patients under the age of 12. The Company anticipates
enrollment to be complete in Q4 2024.
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, and well as utilization
of outcomes-based agreements for LYFGENIA and ZYNTEGLO.
- Based on projected timelines from cell collection to infusion,
the Company expects to recognize revenue from its first infusion of
LYFGENIA in the third quarter of 2024.
FOURTH QUARTER AND ANNUAL FINANCIAL
HIGHLIGHTS
- Cash Position: The Company’s cash, cash equivalents and
restricted cash balance was approximately $275 million, including
restricted cash of approximately $53 million, as of December 31,
2023. Based on launch trajectory and current business plans,
bluebird expects its cash and cash equivalents excluding restricted
cash and assuming three tranches totaling $125 million in proceeds
from its term loan facility are executed, will be sufficient to
meet bluebird’s planned operating expenses and capital expenditure
requirements through Q1 2026. In the fourth quarter of 2023, the
Company entered into a factoring agreement which is accelerating
cash collection related to patient starts across its portfolio of
approved therapies.
- Revenue, net: Total revenue, net was $7.8 million for
the three months ended December 31, 2023, compared to $0.1 million
for the three months ended December 31, 2022. Total revenue, net
was $29.5 million for the twelve months ended December 31, 2023,
compared to $3.6 million for the twelve months ended December 31,
2022. The increase of $25.9 million was primarily due to SKYSONA
and ZYNTEGLO product revenue. For the year ended December 31, 2023,
product revenues by therapy represent $16.7 million attributable to
ZYNTEGLO and $12.4 million attributable to SKYSONA, with
gross-to-net discounts of approximately 19% across both
products.
On March 26, 2024, bluebird announced that it will restate its
consolidated financial statements for 2022, and for the first three
quarters of both 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
with contract manufacturers. As a result, the Company anticipates
recording an increase in lease assets and lease liabilities, as
well as an increase in non-cash interest expense in each restated
period. The Company does not expect the restatement to result in
any impact on its cash position or revenue. bluebird anticipates
filing its 2023 Form 10-K, inclusive of the restatement no later
than April 16, 2024.
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
2023 Form 10-K 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
audit of its consolidated financial statements for the year ended
December 31, 2023.
CONFERENCE CALL DETAILS
bluebird will hold a conference call to discuss its fourth
quarter and 2023 annual results and business updates today,
Tuesday, March 26, 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.
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 and the timing of the first LYFGENIA patient start,
expectations regarding gross-to-net discounts, 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 the commercialization of
LYFGENIA, including without limitation, the potential for robust
commercial uptake of LYFGENIA, the timing of revenue recognition,
patient demand for the therapy, bluebird’s ability to establish
favorable coverage for its therapies, including its ability
successfully partner with payers and its expectations for expansion
of its QTC network , expectations with respect to the completion of
enrollment in HGB-210, and expectations regarding the Company’s
restatement of certain historical financial statements and the
timing for filing of its 2023 10-K. 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. 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 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/20240326211450/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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