Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company
developing novel bile acid modulators, today provided a business
update and reported financial results for the second quarter ended
June 30, 2021.
“Bylvay is now approved in over 30 countries around the world
and we are delighted that the first prescriptions for Bylvay have
been received in the U.S.,” said Ron Cooper, President and Chief
Executive Officer of Albireo. “A successful Bylvay launch is the
main priority but we continue to advance and expand our portfolio
with two additional Phase 3 studies in biliary atresia and Alagille
syndrome and two new compounds, A3907 and A2342, being developed
for adult liver and viral diseases.”
Recent and Upcoming Highlights
Bylvay (odevixibat)
- On July 20, the Company received
U.S. Food & Drug Administration (FDA) approval
of Bylvay, the first drug approved for the
treatment of pruritus in all subtypes of progressive familial
intrahepatic cholestasis (PFIC). Upon approval, the FDA issued a
rare pediatric disease Priority Review Voucher (PRV) for Bylvay.
The Company plans to monetize the PRV as a source of non-dilutive
capital.
- In Europe, the Company
received European Commission (EC) authorization for Bylvay as
the first drug approved for the treatment of all subtypes of PFIC,
with the first launch in Germany.
- First Bylvay prescriptions
generated and first patients enrolled in AlbireoAssistTM, a
customized, in-house patient program with dedicated Care
Coordinators who support patients treated with Bylvay in the U.S.
Albireo and Travere sales representatives and medical teams are
meeting with the approximately 100 key HCPs at 60 centers in the
U.S. to provide education on Bylvay. Value dossiers submitted to
main insurers and meetings set up to obtain access for
patients.
- The Company continues to enroll and
dose patients in two global Phase 3 studies for Alagille syndrome
(ALGS) and biliary atresia. The ASSERT Study is a pivotal trial of
Bylvay in patients with ALGS. The BOLD Study is the first and only
pivotal trial of an IBAT inhibitor in biliary atresia, which is the
largest pediatric cholestatic liver disease. Both studies remain on
track to report topline data with ASSERT in 2022 and BOLD in
2024.
- New data in nine accepted abstracts
presented at European Association for the Study of the Liver (EASL)
International Liver Congress, demonstrating Albireo’s leading
position in the science of bile acid modulation with further
evidence of efficacy and tolerability of Bylvay. Highlights from
the Phase 3 PEDFIC studies showed further evidence of a sustained
and durable effect with Bylvay, while also showing improvements in
sleep, growth and hepatic parameters in patients with PFIC.
- Presented data at the
6th World Congress of Pediatric Gastroenterology, Hepatology,
and Nutrition (WCPGHAN) Meeting. Data from the Phase 3 pivotal
PEDFIC 1 study and the PEDFIC 2 long-term extension study of Bylvay
showed long-term treatment was associated with clinically
meaningful, positive effects on cholestasis, growth and sleep
parameters in patients with PFIC.
Pipeline
- Clinical development continues for A3907, the first oral
systemic apical sodium-dependent bile acid transporter (ASBT)
inhibitor in clinical studies, being developed for adult
cholestatic liver diseases such as primary sclerosing cholangitis
(PSC) and primary biliary cholangitis (PBC). A Phase 1,
first-in-human, double-blind, single and multiple ascending dose
study in healthy adult subjects to investigate the safety,
tolerability, pharmacokinetics and pharmacodynamics of an A3907
oral formulation is underway with data readout expected by end of
year.
- Data presented at EASL on Phase 1 candidate, A3907, showing
positive impacts on markers of cholestatic disease.
- The Company is completing
IND-enabling studies for A2342, the first potent oral systemic
sodium-taurocholate co-transporting peptide (NTCP) inhibitor for
development in viral and cholestatic liver diseases.
Corporate
- Presented a corporate overview at
several investor conferences during the quarter, including the
William Blair Biotech Focus Conference 2021, Piper Sandler’s
Virtual EASL Takeaway Day, Jefferies Virtual Healthcare Conference
and William Blair’s 41st Annual Growth Stock Conference.
Second Quarter 2021 Financial Results
- Revenues were $2.4 million for the second quarter of 2021,
compared to $1.9 million for the second quarter of 2020. The higher
revenue was due to the estimated royalty revenue to be received
from EA Pharma for elobixibat for the treatment of chronic
constipation. The royalty revenue is passed on to HealthCare
Royalty Partners.
- R&D expenses were $20.9 million for the second quarter of
2021, compared to $18.4 million for the second quarter of 2020. The
higher expenses were principally due to personnel expenses as the
Company continues to increase our headcount and program activities.
The increase in program activities related to Bylvay consisting of
biliary atresia and Alagille syndrome, and A3907 were partially
offset by Bylvay PFIC expenses, elobixibat and preclinical
programs.
- G&A expenses were $16.9 million for the second quarter of
2021, compared to $8.5 million for the second quarter of 2020. The
increase is attributable to personnel and related expenses as the
Company continued to increase headcount and commercialization
readiness activities related to Bylvay.
- Net loss for the second quarter of 2021 was $36.4 million, or
$(1.90) per share, compared to $20.6 million, or $(1.38) per share
for the second quarter of 2020.
- The Company had cash and cash equivalents of $186.3 million as
of June 30, 2021 compared to $217.1 million at March 31, 2021. The
company anticipates the 2021 operating cash burn will be between
$130-$135 million. 2021 revenue from Bylvay is anticipated to be in
the low single digit U.S. $ millions. The Company anticipates cash
runway into 2023, excluding any proceeds from the planned sale of
the PRV received on approval, which should be sufficient to launch
Bylvay and expansion beyond PFIC.
Conference CallTo access the live conference
call by phone, please dial 877-407-0792 (domestic) or 201-689-8263
(international) and provide the access code 13720893. Live audio
webcast will be accessible from the Media & Investors page of
Albireo’s website. To ensure a timely connection to the webcast, it
is recommended that participants register at least 15 minutes prior
to the scheduled start time. An archived version of the webcast
will be available for replay on the Events & Presentations
section of the Media & Investors page of Albireo’s website for
3 months following the event.
About Bylvay
(odevixibat)Bylvay is the first drug treatment
approved in the U.S. for the treatment of pruritus in all subtypes
of progressive familial intrahepatic cholestasis (PFIC). The
European Commission (EC) has also granted marketing authorization
of Bylvay in PFIC and will be available for sale in Europe
following pricing and reimbursement approval. A potent, once-daily,
non-systemic ileal bile acid transport inhibitor, Bylvay acts
locally in the small intestine. Bylvay does not require
refrigeration and can be taken as a capsule for older children, or
opened and sprinkled onto food, which are factors of key importance
for adherence in a pediatric patient population. The medicine can
only be obtained with a prescription and treatment should be
started and supervised by a doctor who has experience in the
management of PFIC. For more information about using Bylvay, see
the package leaflet or contact your doctor or pharmacist. For full
prescribing information, visit www.bylvay.com.
In the U.S. and Europe, Bylvay has orphan exclusivity for its
approved PFIC indications, and orphan designations for the
treatment of Alagille syndrome, biliary atresia and primary biliary
cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2
open-label trial in patients with PFIC, in the BOLD Phase 3 study
for patients with biliary atresia and the ASSERT Phase 3 study for
Alagille syndrome.
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 product,
Bylvay, was approved by the U.S. FDA as the first drug for the
treatment of pruritus in all subtypes of progressive familial
intrahepatic cholestasis (PFIC), and 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 initiated
a Phase 1 clinical trial for A3907 to advance development in adult
cholestatic liver disease, with IND-enabling studies moving ahead
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 2020
Best Places to Work in Massachusetts for the second consecutive
year. For more information on Albireo, please visit
www.albireopharma.com.
Forward-Looking StatementsThis 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: Albireo’s commercialization
plans and expectations for commercializing Bylvay in the U.S. and
Europe; estimates of the number of patients impacted by PFIC;
expectations about Bylvay’s acceptance by healthcare practitioners
to treat PFIC patients; Albireo’s plans to monetize its Rare
Pediatric Disease Priority Review Voucher; 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), and the pivotal
trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial
for A3907; 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, and the BOLD and
ASSERT trials; discussions with the FDA or EMA regarding our
programs; the potential benefits or competitive position of Bylvay
or any other Albireo product candidate or program or the commercial
opportunity in any target indication; the potential effects of
Bylvay of the treatment of PFIC patients and its potential to
improve the current standard of care; the potential benefits of an
orphan drug designation; the length of time for which Albireo’s
cash resources are expected to be sufficient, and the milestones
and activities to be funded with those cash resources; or Albireo’s
plans, expectations or future operations, financial position,
revenues, costs or expenses. 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:
there are no guarantees that Bylvay will be commercially
successful; we may encounter issues, delays or other challenges in
launching or commercializing Bylvay; whether Bylvay receives
adequate reimbursement from third-party payors; the degree to which
Bylvay receives acceptance from patients and physicians for its
approved indication; challenges associated with execution of our
sales activities, which in each case could limit the potential of
our product; results achieved in Bylvay in the treatment of
patients with PFIC once we have launched the product may be
different than observed in clinical trials, and may vary among
patients; other potential negative impacts of the COVID-19
pandemic, including on manufacturing, supply, conduct or initiation
of clinical trials, or other aspects of our business; 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
outcome and interpretation by regulatory authorities of the ongoing
third-party study pooling and analyzing of long-term PFIC patient
data; 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, Company’s clinical trials; and
Albireo’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.comLisa
Rivero, 617-947-0899, lisa.rivero@syneoshealth.com
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC., 617-430-7578
Albireo Pharma,
Inc.Condensed Consolidated Balance
Sheets(in thousands, except share and per share
data)(unaudited)
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
186,286 |
|
|
$ |
251,272 |
|
Prepaid expenses and other current assets |
|
|
8,966 |
|
|
|
10,593 |
|
Total current assets |
|
|
195,252 |
|
|
|
261,865 |
|
Property and equipment,
net |
|
|
868 |
|
|
|
478 |
|
Goodwill |
|
|
17,260 |
|
|
|
17,260 |
|
Other assets |
|
|
6,117 |
|
|
|
6,004 |
|
Total assets |
|
$ |
219,497 |
|
|
$ |
285,607 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,704 |
|
|
$ |
5,283 |
|
Accrued expenses |
|
|
18,047 |
|
|
|
19,051 |
|
Current portion of note payable, net of discount |
|
|
1,992 |
|
|
|
— |
|
Other current liabilities |
|
|
1,250 |
|
|
|
948 |
|
Total current liabilities |
|
|
26,993 |
|
|
|
25,282 |
|
Liability related to sale of
future royalties |
|
|
67,834 |
|
|
|
65,894 |
|
Note payable, net of
discount |
|
|
7,865 |
|
|
|
9,621 |
|
Other long-term
liabilities |
|
|
3,301 |
|
|
|
3,579 |
|
Total liabilities |
|
|
105,993 |
|
|
|
104,376 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Preferred stock, $0.01 par value per share — 50,000,000 authorized
at June 30, 2021 and December 31, 2020; 0 and 0
issued and outstanding at June 30, 2021 and
December 31, 2020, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value per share — 60,000,000 authorized at
June 30, 2021 and December 31, 2020; 19,240,295
and 19,107,040 issued and outstanding at June 30, 2021
and December 31, 2020, respectively |
|
|
192 |
|
|
|
191 |
|
Additional paid-in capital |
|
|
464,665 |
|
|
|
456,472 |
|
Accumulated other comprehensive loss |
|
|
(4,379 |
) |
|
|
(8,612 |
) |
Accumulated deficit |
|
|
(346,974 |
) |
|
|
(266,820 |
) |
Total stockholders’ equity |
|
|
113,504 |
|
|
|
181,231 |
|
Total liabilities and
stockholders’ equity |
|
$ |
219,497 |
|
|
$ |
285,607 |
|
Albireo Pharma,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except share and per
share data)(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue |
|
$ |
2,428 |
|
|
$ |
1,912 |
|
|
$ |
4,394 |
|
|
$ |
3,461 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,894 |
|
|
|
18,397 |
|
|
|
40,837 |
|
|
|
34,527 |
|
General and administrative |
|
|
16,940 |
|
|
|
8,474 |
|
|
|
32,213 |
|
|
|
16,627 |
|
Other operating (income) expense, net |
|
|
(2,374 |
) |
|
|
(6,744 |
) |
|
|
4,154 |
|
|
|
72 |
|
Total operating expenses |
|
|
35,460 |
|
|
|
20,127 |
|
|
|
77,204 |
|
|
|
51,226 |
|
Operating loss |
|
|
(33,032 |
) |
|
|
(18,215 |
) |
|
|
(72,810 |
) |
|
|
(47,765 |
) |
Interest expense, net |
|
|
(3,389 |
) |
|
|
(2,388 |
) |
|
|
(7,344 |
) |
|
|
(4,326 |
) |
Net loss |
|
$ |
(36,421 |
) |
|
$ |
(20,603 |
) |
|
$ |
(80,154 |
) |
|
$ |
(52,091 |
) |
Net loss per share
attributable to holders of common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
|
$ |
(1.90 |
) |
|
$ |
(1.38 |
) |
|
$ |
(4.18 |
) |
|
$ |
(3.58 |
) |
Weighted-average common shares used to compute basic and diluted
net loss per common share |
|
|
19,200,747 |
|
|
|
14,981,756 |
|
|
|
19,196,798 |
|
|
|
14,556,986 |
|
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