Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company
developing novel bile acid modulators, updated guidance for Bylvay
net sales, cash and the two Phase 3 clinical studies. Global Bylvay
net sales in 2021 are expected to be $6-7 million, higher than
previous guidance of $3-4 million. Unaudited cash and cash
equivalents as of December 31, 2021 was at least $248 million, and
the Company expects to have sufficient cash into 2024 based on
current revenue and expense projections. Albireo has two ongoing
Phase 3 studies which are progressing according to plan, with the
BOLD study in biliary atresia passing the 50% enrollment milestone
and the ASSERT study on track for topline data by the end of 2022.
“Bylvay launch uptake has been faster than anticipated and has
significantly exceeded our internal expectations,” said Ron Cooper,
President and Chief Executive Officer of Albireo. “At the same
time, our cash position is strong, and we are pleased that our two
Phase 3 studies are enrolling as planned and look forward to
additional data in 2022.”
The Company has unaudited cash and cash equivalents of at
least $248 million as of December 31, 2021 versus $262.6 million as
of September 30, 2021, providing the Company with sufficient
capital resources to fund the continued launch of Bylvay and
advancement of its development programs as planned.
Bylvay is a potent, non-systemic ileal bile acid transport
inhibitor (IBATi) which was recently approved in the U.S. for the
treatment of pruritus in patients 3 months of age and older in all
types of PFIC, and in Europe for the treatment of all types of PFIC
in patients aged 6 months or older. The Company continues to enroll
and dose patients in the Phase 3 ASSERT study, a pivotal trial of
Bylvay in patients with Alagille syndrome, and remains on track for
topline data by the end of 2022. Biliary atresia is the most common
pediatric cholestatic liver disease with no approved drug
treatment. The Phase 3 BOLD study, which is the first and only
pivotal trial of an IBATi in biliary atresia, has passed the 50%
enrollment milestone and remains on track for topline data in
2024.
The early development pipeline continues to advance. A3907, the
first oral systemic ASBT inhibitor, is expected to enter Phase 2
for adult liver diseases and A2342, the first oral NTCP inhibitor
being developed for hepatitis B and D, will begin first in human
studies this year.
The Company’s management will participate in the H.C. Wainwright
Virtual BioConnect 2022 Conference to be held January 10-13,
2022. The presentation will be available beginning January 10,
2022 on the Investors page of the company website at
https://ir.albireopharma.com/ and archived for replay two weeks
following the event. The Company starts the year with a strong
financial and commercial position based on the following milestones
achieved in 2021:
- First patient dosed
in ASSERT global Phase 3 study of Bylvay for Alagille syndrome
- European Marketing
Authorization of Bylvay, the First Drug Treatment for Progressive
Familial Intrahepatic Cholestasis (PFIC)
- FDA Approval of
Bylvay, the First Drug Treatment for Patients With Progressive
Familial Intrahepatic Cholestasis (PFIC)
- Albireo Sells
Priority Review Voucher (PRV) for $105 Million
- Albireo Receives UK
MHRA Approval of Bylvay® (odevixibat)
- Bylvay Available in
Germany
- Expanded Phase 3
Data on Bylvay and A3907 at Upcoming EASL International Liver
Congress
- New Phase 3 Data at
WCPGHAN Show Long-Term Safety, Tolerability, and Treatment Benefits
of Bylvay in PFIC
- New Phase 3 Data for
Bylvay in PFIC and First Reveal of New Next Generation Bile Acid
Modulator Data at AASLD The Liver Meeting 2021
- Albireo Presenting
New Bylvay Data at NASPGHAN 2021
- Exclusive Licensing
Agreement with Jadeite Medicines for Bylvay in Japan with upfront
payment of $15M and up to $120M in milestones and double-digit
royalties
- Positive Topline
Data from Phase 1 Study of A3907
The Company also congratulates Dr. Roger A. Jeffs on his
appointment as Chief Executive Officer of Liquidia Corporation as
of January 3, 2022. With this new leadership role, Dr. Jeffs will
leave the Albireo Board of Directors to focus on his new business
obligations. Dr. Jeffs joined the Board in 2017 and has seen the
Company through growth and development of the pipeline as well as
the global commercialization of Bylvay.
“Over the last five years, Roger has been a dedicated member of
our Board and his contributions have been invaluable as we achieved
major milestones, including global commercialization of our first
product and exceeding our product revenue forecast in the first
quarter of sales. We thank Roger for his contributions over his
tenure and wish him luck in his new role,” added Cooper.
About AlbireoAlbireo Pharma is a rare disease
company focused on the development of novel bile acid modulators to
treat rare pediatric and adult liver diseases. Albireo’s lead
product, Bylvay, was approved by the U.S. FDA as the first drug for
the treatment of pruritus in all types of progressive familial
intrahepatic cholestasis (PFIC), and it is also being developed to
treat other rare pediatric cholestatic liver diseases with Phase 3
trials in Alagille syndrome and biliary atresia, as well as an
Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has
been approved for the treatment of PFIC and has been submitted for
pricing and reimbursement approval. The Company has also completed
a Phase 1 clinical trial for A3907 to advance development in adult
cholestatic liver disease, with IND-enabling studies progressing
with A2342 for viral and cholestatic liver disease. Albireo was
spun out from AstraZeneca in 2008 and is headquartered in Boston,
Massachusetts, with its key operating subsidiary in Gothenburg,
Sweden. The Boston Business Journal named Albireo one of the 2019
and 2020 Best Places to Work in Massachusetts. For more information
on Albireo, please visit www.albireopharma.com.
Forward-Looking Statements This press release
includes “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements, other than statements of historical
fact, regarding, among other things: the plans for, or progress,
scope, cost, initiation, duration, enrollment, results or timing
for availability of results of, development of Bylvay, A3907, A2342
or any other Albireo product candidate or program; the pivotal
trial for Bylvay in biliary atresia (BOLD); the pivotal trial for
Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907;
the IND-enabling studies for A2342; the target indication(s) for
development or approval; the size, design, population, location,
conduct, cost, objective, enrollment, duration or endpoints of any
clinical trial, or the timing for initiation or completion of or
availability or reporting of results from any clinical trial,
including the long-term open-label extension study for Bylvay in
PFIC, the BOLD and ASSERT trials, Phase 2 trial for A3907 and the
IND-enabling studies for A2342; or the potential benefits or
competitive position of Bylvay or any other Albireo product
candidate or program or the commercial opportunity in any target
indication; Albireo often uses words such as “anticipates,”
“believes,” “plans,” “expects,” “projects,” “future,” “intends,”
“may,” “will,” “should,” “could,” “estimates,” “predicts,”
“potential,” “planned,” “continue,” “guidance,” or the negative of
these terms or other similar expressions to identify
forward-looking statements. Actual results, performance or
experience may differ materially from those expressed or implied by
any forward-looking statement as a result of various risks,
uncertainties and other factors, including, but not limited to:
whether favorable findings from clinical trials of Bylvay to date,
including findings in indications other than PFIC, will be
predictive of results from other clinical trials of Bylvay; the
timing for initiation or completion of, or for availability of data
from, clinical trials of Bylvay, including BOLD and ASSERT, and the
Phase 1 clinical trial of A3907, and the outcomes of such trials;
Albireo’s ability to obtain coverage, pricing or reimbursement for
approved products in the United States or Europe; delays or other
challenges in the recruitment of patients for, or the conduct of,
the Company’s clinical trials; and the Company’s critical
accounting policies. These and other risks and uncertainties that
Albireo faces are described in greater detail under the heading
“Risk Factors” in Albireo’s most recent Annual Report on Form 10-K
or in subsequent filings that it makes with the Securities and
Exchange Commission. As a result of risks and uncertainties that
Albireo faces, the results or events indicated by any
forward-looking statement may not occur. Albireo cautions you not
to place undue reliance on any forward-looking statement. In
addition, any forward-looking statement in this press release
represents Albireo’s views only as of the date of this press
release and should not be relied upon as representing its views as
of any subsequent date. Albireo disclaims any obligation to update
any forward-looking statement except as required by applicable
law.
Media Contact:Colleen Alabiso,
857-356-3905, colleen.alabiso@albireopharma.com
Investor Contact:Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
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