Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today provided a business update and reported financial
results for the first quarter ended March 31, 2020.
“Despite the unprecedented challenges of COVID-19, our
fundamentals remain unchanged, and we continue to make significant
progress across our development programs, while accelerating
preparations for commercialization,” said Ron Cooper, President and
Chief Executive Officer of Albireo. “In PFIC, we are now months
away from our Phase 3 data readout, and we are advancing our
preparations in manufacturing, market development, market access,
patient support and other areas. Meanwhile, we are advancing
pivotal trials in biliary atresia and Alagille syndrome, and our
NASH program is making excellent progress, with data readout from
our Phase 2 trial also a few months away.
“COVID-19 has had a sweeping impact across the industry and
society as a whole. We have successfully adapted our business
operations, with the safety of our employees and the patient
communities as our top priority. We are fortunate that our clinical
trials in PFIC and NASH have completed enrollment this quarter, and
we have sufficient clinical trial supply to support those programs.
As of now, our prior guidance regarding our clinical trials remains
unchanged.”
More information on the impact of COVID-19 on Albireo is
available at albireopharma.com.
Recent Highlights
Odevixibat
- With the PEDFIC 1 trial fully randomized, have accelerated
preparations for commercialization. More than three-quarters of
patients have completed the trial, and we continue to expect
topline results mid-2020 and anticipate potential first regulatory
approval H2 2021.
- We have initiated the first clinical trial sites for the BOLD
pivotal study, Biliary Atresia and the Use of
Odevixibat in Treating Liver
Disease. Biliary atresia is a rare pediatric liver
disease that is the leading cause of liver transplants among
children, and for which there is no approved pharmacological
therapy. Biliary atresia is the most common rare pediatric
cholestatic liver disease and the largest market opportunity in
that therapeutic category. The U.S. Food and Drug Administration
(FDA) and European Commission have granted orphan designations for
odevixibat in the treatment of biliary atresia.
- Received FDA feedback and are finalizing pivotal trial design
in Alagille syndrome. Anticipate initiating trial by the end of
this year. The FDA and the European Commission have granted orphan
designations for odevixibat in the treatment of Alagille
syndrome.
Pipeline
- Achieved full enrollment in elobixibat Phase 2 trial in NAFLD
and NASH. Proof-of-concept study is the first study ever conducted
in both NAFLD and NASH patients with an IBAT inhibitor. Expect
topline data by mid 2020. Additionally, expect topline data from
another Phase 2 trial being conducted through our partner EA Pharma
in Japan by the end of the year or early next year.
- Continued as planned IND-enabling studies of lead preclinical
candidate with novel mechanism of action.
Corporate
- Completed equity capital raise of net $43.0 million.
First Quarter 2020 Financial Results
- Revenues were $1.5 million for the first quarter of 2020,
compared with $0.6 million for the first quarter of 2019. The
higher revenue was due to the estimated royalty revenue
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 $16.1 million for the first quarter of
2020, compared with $8.3 million for the first quarter of 2019. The
higher expenses were primarily due to program expenses for
odevixibat and elobixibat, as well as personnel costs, as we
continue to increase our program activities and
headcount.
- G&A expenses were $8.2 million for the first quarter of
2020, compared with $5.3 million for the first quarter of 2019. The
increase was attributable to personnel and related expenses, as we
continue to increase our headcount, and commercialization readiness
expenses.
- Net loss for the first quarter of 2020 was $31.5 million, or
$(2.23) per share, compared with $16.7 million, or $(1.39) per
share for the first quarter of 2019.
- The company had cash and cash equivalents at March 31, 2020, of
$150.5 million, which compares with $150.3 million at March 31,
2019. During the first quarter of 2020, an additional $43.0 million
of net cash was raised through an underwritten public offering of
our common stock. As a result, cash and cash equivalents are
anticipated to be sufficient into the second half of 2021.
Conference CallAs previously announced, Albireo
will host a conference call and webcast today, May 7, 2020, at
10:00 a.m. ET. To access the live conference call by phone, dial
877-407-0792 (domestic) or 201-689-8263 (international),
and provide the access code 13699920. A live audio webcast will be
accessible from the Media & Investors page of Albireo’s
website, http://ir.albireopharma.com/. 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 Albireo Albireo Pharma is a
clinical-stage biopharmaceutical company focused on the development
of novel bile acid modulators to treat orphan pediatric liver
diseases, and other liver and gastrointestinal diseases and
disorders. Albireo’s lead product candidate, odevixibat, is being
developed to treat rare pediatric cholestatic liver diseases, and
is in Phase 3 clinical trials in both progressive familial
intrahepatic cholestasis (PFIC) and biliary atresia. Albireo’s
clinical pipeline also includes two Phase 2 product candidates.
Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in
Japan for the treatment of chronic constipation, elobixibat is the
first ileal bile acid transporter (IBAT) inhibitor approved
anywhere in the world.
Albireo was spun out from AstraZeneca in 2008. Albireo Pharma is
located in Boston, Mass., and its key operating subsidiary is
located in Gothenburg, Sweden. The Boston Business Journal named
Albireo one of the 2019 Best Places to Work in Massachusetts. For
more information on Albireo, please visit
www.albireopharma.com.
About OdevixibatOdevixibat is a product
candidate being developed to treat rare pediatric cholestatic liver
diseases and is in Phase 3 development in both progressive familial
intrahepatic cholestasis (PFIC) and biliary atresia. A highly
potent and selective inhibitor of the ileal bile acid transporter
(IBAT), odevixibat has minimal systemic exposure and acts locally
in the small intestine.
The odevixibat PFIC program has received fast track, rare
pediatric disease and orphan drug designations in the United
States. In addition, the U.S. Food and Drug Administration (FDA)
has granted orphan drug designation to odevixibat for the treatment
of Alagille syndrome, biliary atresia and primary biliary
cholangitis. The European Medicines Agency (EMA) has granted
odevixibat orphan designation, as well as access to the PRIority
MEdicines (PRIME) scheme for the treatment of PFIC. Its Pediatric
Committee has agreed to Albireo's odevixibat Pediatric
Investigation Plan for PFIC. EMA also has granted orphan
designation to odevixibat for the treatment of Alagille syndrome,
biliary atresia and primary biliary cholangitis.
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 odevixibat, elobixibat or any other Albireo product
candidate or program, including regarding expectations regarding
the impact of COVID-19 on our business and our ability to adapt our
approach as appropriate; the Phase 3 clinical program for
odevixibat in patients with PFIC, the pivotal trial for odevixibat
in biliary atresia, the planned pivotal trial for odevixibat in
Alagille syndrome, the Phase 2 clinical trial for elobixibat in
NAFLD/NASH, and another Phase 3 trial for elobixibat being
conducted by EA Pharma in Japan; 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 Phase 3 PFIC trial for odevixibat, and the long-term
open-label extension study, the pivotal trial for odevixibat in
biliary atresia, the planned pivotal trial for odevixibat in
Alagille syndrome, or the Phase 2 trial for elobixibat in
NAFLD/NASH; the potential approval and commercialization of
odevixibat; discussions with the FDA or EMA regarding our programs;
the potential benefits or competitive position of odevixibat,
elobixibat, or any other Albireo product candidate or program or
the commercial opportunity in any target indication; the potential
benefits of an orphan drug designation; the period for which
Albireo’s cash resources will be sufficient to fund its operating
requirements (runway); 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,” and 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: 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 odevixibat to date,
including findings in indications other than PFIC, will be
predictive of results from the trials comprising the Phase 3 PFIC
program or any other clinical trials of odevixibat; whether either
or both of the FDA and EMA will determine that the
primary endpoint for their respective evaluations and treatment
duration of the double-blind Phase 3 trial in patients with PFIC
are sufficient, even if the primary endpoint is met with
statistical significance, to support approval of odevixibat
in the United States or the European Union, to treat
PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise;
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 odevixibat, including
the trials comprising the Phase 3 PFIC program, the pivotal program
in biliary atresia or the planned pivotal program in Alagille
syndrome, and the outcomes of such trials; Albireo’s ability to
obtain coverage, pricing or reimbursement for approved products
in the United States or European Union; delays or
other challenges in the recruitment of patients for, or the conduct
of, the double-blind Phase 3 trial or other pivotal 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.
Investor Contact: Hans Vitzthum, LifeSci
Advisors, LLC.,
212-915-2568
Media Contact: Heather Anderson, 6 Degrees,
980-938-0260, handerson@6degreespr.com
Albireo Pharma, Inc.
Condensed Consolidated Balance
Sheets
(in thousands, except share and per share
data)
(unaudited)
|
|
March 31, |
|
December
31, |
|
|
|
2020 |
|
|
2019 |
|
|
Assets |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
150,515 |
|
|
$ |
131,843 |
|
|
Prepaid expenses and other current assets |
|
|
7,818 |
|
|
|
9,956 |
|
|
Total current assets |
|
|
158,333 |
|
|
|
141,799 |
|
|
Property and
equipment, net |
|
|
554 |
|
|
|
597 |
|
|
Goodwill |
|
|
17,260 |
|
|
|
17,260 |
|
|
Other
assets |
|
|
5,962 |
|
|
|
5,413 |
|
|
Total
assets |
|
$ |
182,109 |
|
|
$ |
165,069 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,788 |
|
|
$ |
4,785 |
|
|
Accrued expenses |
|
|
7,561 |
|
|
|
13,486 |
|
|
Other current liabilities |
|
|
798 |
|
|
|
653 |
|
|
Total
current liabilities |
|
|
15,147 |
|
|
|
18,924 |
|
|
Liability
related to sale of future royalties |
|
|
49,407 |
|
|
|
48,714 |
|
|
Other
long-term liabilities |
|
|
4,121 |
|
|
|
4,270 |
|
|
Total
liabilities |
|
|
68,675 |
|
|
|
71,908 |
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
Common stock, $0.01 par value per share — 30,000,000 authorized at
March 31, 2020 and December 31, 2019;
14,977,855 and 12,749,443 issued and outstanding at
March 31, 2020 and December 31, 2019,
respectively |
|
|
149 |
|
|
|
127 |
|
|
Additional paid-in capital |
|
|
291,221 |
|
|
|
245,769 |
|
|
Accumulated other comprehensive income |
|
|
12,739 |
|
|
|
6,452 |
|
|
Accumulated deficit |
|
|
(190,675 |
) |
|
|
(159,187 |
) |
|
Total stockholders’ equity |
|
|
113,434 |
|
|
|
93,161 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
182,109 |
|
|
$ |
165,069 |
|
|
|
|
|
|
|
|
|
|
Albireo Pharma, Inc.
Condensed Consolidated Statements of
Operations
(in thousands, except share and per share
data)
(unaudited)
|
Three Months Ended March 31, |
|
2020 |
|
|
2019 |
|
Revenue |
$ |
1,549 |
|
|
$ |
570 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
16,130 |
|
|
|
8,329 |
|
General and administrative |
|
8,153 |
|
|
|
5,293 |
|
Other operating expense, net |
|
6,816 |
|
|
|
2,296 |
|
Total operating expenses |
|
31,099 |
|
|
|
15,918 |
|
Operating
loss |
|
(29,550 |
) |
|
|
(15,348 |
) |
Interest expense, net |
|
(1,938 |
) |
|
|
(1,309 |
) |
Net
loss |
$ |
(31,488 |
) |
|
$ |
(16,657 |
) |
Net loss per share attributable to holders of common stock: |
|
|
|
|
|
Net loss per common share - basic and diluted |
$ |
(2.23 |
) |
|
$ |
(1.39 |
) |
Weighted-average shares outstanding: |
|
|
|
|
|
Weighted-average common shares used to compute basic and diluted
net loss per common share |
|
14,132,217 |
|
|
|
12,001,125 |
|
Albireo Pharma (NASDAQ:ALBO)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Albireo Pharma (NASDAQ:ALBO)
Historical Stock Chart
Von Apr 2023 bis Apr 2024