Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan
pediatric liver disease company developing novel bile acid
modulators, today announced financial results and corporate
highlights for the first quarter ended March 31, 2019.
“For Albireo, 2019 is focused on advancing toward potential
approval and launch of odevixibat in its first indication, while
further developing odevixibat into a pediatric cholestasis medicine
that could benefit people across multiple rare diseases,” said Ron
Cooper, President and Chief Executive Officer of Albireo. “In the
first quarter, we continued to make significant progress on both
fronts. While we anticipate PEDFIC 1 topline results at the end of
this year or early 2020, we are pleased to expand the PEDFIC
program to generate data on additional patient types. We also are
extremely excited to be preparing for a pivotal trial with
odevixibat in biliary atresia, building on promising results from
our Phase 2 trial. In addition, our NASH program is gaining
momentum, as we prepare to begin a Phase 2 trial in NAFLD/NASH with
elobixibat this quarter.”
Recent Highlights
Odevixibat (A4250)
- Achieved 43 trial sites activated in the U.S., Europe and other
territories for the PEDFIC 1 Phase 3 study in PFIC as of May 1.
PEDFIC 1 is enrolling PFIC subtypes 1 and 2. Expect topline trial
results in late 2019 or early 2020, and plan to refine guidance on
full enrollment of the study.
- Data in a wider range of PFIC patient types will be generated
to support odevixibat in a planned additional patient cohort of
PEDFIC 2, the long-term, open-label extension study of PEDFIC 1.
The additional cohort will include PFIC patients who are not
eligible for PEDFIC 1, including additional PFIC types, adults and
neonates. We anticipate initiation of this additional cohort in the
second half of this year.
- Held scientific advice meeting with the European Medicines
Agency (EMA), following meeting with the Food and Drug
Administration (FDA), on design of odevixibat pivotal trial in
biliary atresia. Plan to initiate trial in H2 2019.
- Granted orphan drug designation from the FDA for odevixibat for
treatment of biliary atresia, estimated to be one of the larger
rare pediatric liver diseases, with extremely high unmet need.
- Presented data from our Phase 2 trial in pediatric cholestasis
that support the potential of odevixibat in biliary atresia and
Alagille syndrome at the European Association for the Study of the
Liver (EASL) annual conference held in April in Vienna, Austria.
The Alagille data were selected for inclusion in “The Best of ILC,”
which EASL prepared to highlight the most noteworthy contributions
to the scientific program at the conference this year.
- Also at EASL, the academic consortium NAPPED (NAtural course
and Prognosis of PFIC and Effect of biliary Diversion), which has
the world’s largest PFIC database, presented data on the natural
history of PFIC. Notably, the NAPPED data showed that surgical
biliary diversion improved survival in PFIC2 patients and that
lowering serum bile acids to 118 μmol/L or a reduction of 70% was
associated with favorable native liver survival outcomes. Albireo
is one of the sponsors of NAPPED through an unrestricted
grant.
- Odevixibat published in WHO Drug Information as the recommended
international name for A4250.
Elobixibat
- Submitted an IND and was cleared by FDA to begin a Phase 2
multicenter, placebo-controlled trial of elobixibat in
NAFLD/NASH.
Corporate
- Presented at several conferences, including: the 39th Annual
Cowen Health Care conference in Boston, the Roth conferences in
California and New York, the H.C. Wainwright conference in London
and the Needham Healthcare conference in New York.
- Strengthened the Company’s commercial team with the appointment
of Pamela Stephenson as Chief Commercial Officer.
First-Quarter Financial Highlights
- Revenues were $570 thousand in the first quarter of 2019,
compared to $11.2 million in the first quarter of 2018.
- R&D expense was $8.3 million for the first quarter of 2019,
up 35.4% from $6.2 million in the first quarter of 2018.
- G&A expense was $5.3 million for the first quarter of 2019,
up 28.2% compared to $4.1 million in the first quarter of
2018.
- Net Loss in the first quarter of 2019 was $16.7 million, or
$(1.39) per share, compared to $1.6 million, or $(0.15) per share
in the first quarter of 2018.
- The Company had cash and cash equivalents at March 31, 2019, of
$150.3 million.
Financial GuidanceFor the full year 2019, we
anticipate total expenses, including R&D and G&A expenses,
to be in the range of $75-$80 million. We anticipate our current
cash balance to be sufficient to meet our operating needs into
2021.
Conference CallAs previously announced, Albireo
will host a conference call and webcast today, May 9, 2019, at
10 a.m. EDT. To access the live conference call by phone, dial
877-407-0792 (domestic) or 201-689-8263 (international), and
provide the access code 13688060. 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 in the
Events & Presentations section of the Media & Investors
page of Albireo’s website for 1 year following the event.
About Albireo Albireo Pharma is a
clinical-stage biopharmaceutical company focused through its
operating subsidiary 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 (A4250), is being developed to treat
rare pediatric cholestatic liver diseases and is in Phase 3
development in its initial target indication, progressive familial
intrahepatic cholestasis (PFIC). Albireo’s clinical pipeline also
includes two Phase 2 product candidates. Albireo’s elobixibat,
approved in Japan for the treatment of chronic
constipation, 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, Massachusetts, 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.
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, duration or results or
timing for availability of results of, development of odevixibat,
elobixibat or any other Albireo product candidate or program,
including regarding the Phase 3 clinical program for odevixibat in
patients with PFIC; the planned pivotal trial for odevixibat in
biliary atresia, the planned Phase 2 clinical trial for elobixibat
in NAFLD/NASH, the target indication(s) for development, the size,
design, population, location, conduct, objective, enrollment,
duration or endpoints of any clinical trial, or the timing for
initiation or completion of or reporting of results from any
clinical trial, including the double-blind Phase 3 PFIC trial for
odevixibat, the planned pivotal trial for odevixibat in biliary
atresia or the planned Phase 2 trial for elobixibat in NAFLD/NASH;
the potential approval and commercialization of odevixibat; the
size of the PFIC population, the biliary atresia population, the
NASH population or any other disease population for indications
that may be targeted by Albireo; 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 pricing of odevixibat if approved; 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: 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, 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;
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 VitzthumLifeSci Advisors,
LLC212-915-2568
Media Contact:Heather Anderson6
Degrees980-938-0260handerson@6degreespr.com
Source: Albireo Pharma, Inc.
Albireo Pharma,
Inc.Condensed Consolidated Balance
Sheets(in thousands, except share and per share
data)(unaudited)
|
|
March 31, |
|
December 31, |
|
|
2019 |
|
2018 |
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
150,339 |
|
|
$ |
163,885 |
|
Prepaid expenses and other assets |
|
|
1,194 |
|
|
|
850 |
|
Other receivables |
|
|
2,803 |
|
|
|
2,915 |
|
Total current assets |
|
|
154,336 |
|
|
|
167,650 |
|
Property and equipment,
net |
|
|
173 |
|
|
|
187 |
|
Goodwill |
|
|
17,260 |
|
|
|
17,260 |
|
Other noncurrent assets |
|
|
1,209 |
|
|
|
369 |
|
Total assets |
|
$ |
172,978 |
|
|
$ |
185,466 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Trade payables |
|
$ |
2,987 |
|
|
$ |
4,352 |
|
Accrued expenses |
|
|
6,385 |
|
|
|
8,165 |
|
Other liabilities |
|
|
569 |
|
|
|
308 |
|
Total current liabilities |
|
|
9,941 |
|
|
|
12,825 |
|
Liability related to sale of
future royalties |
|
|
51,433 |
|
|
|
49,969 |
|
Long-term liabilities |
|
|
213 |
|
|
|
35 |
|
Total liabilities |
|
|
61,587 |
|
|
|
62,829 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Common stock, $0.01 par value per share — 30,000,000 authorized
atMarch 31, 2019 and December 31, 2018;
12,038,836 and 11,969,928 issuedand outstanding at
March 31, 2019 December 31, 2018 |
|
|
120 |
|
|
|
120 |
|
Additional paid in capital |
|
|
217,807 |
|
|
|
214,694 |
|
Accumulated other comprehensive income |
|
|
6,591 |
|
|
|
4,293 |
|
Accumulated deficit |
|
|
(113,127 |
) |
|
|
(96,470 |
) |
Total stockholders’ equity |
|
|
111,391 |
|
|
|
122,637 |
|
Total liabilities and
stockholders’ equity |
|
$ |
172,978 |
|
|
$ |
185,466 |
|
Albireo Pharma,
Inc.Condensed Consolidated Statement of
Operations(in thousands, except share and per
share data)(unaudited)
|
|
Three Months Ended March 31, |
|
|
2019 |
|
2018 |
Revenue |
|
$ |
570 |
|
|
$ |
11,202 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
|
8,329 |
|
|
|
6,151 |
|
General and administrative |
|
|
5,293 |
|
|
|
4,128 |
|
Other operating (income) expense, net |
|
|
2,296 |
|
|
|
1,504 |
|
Total operating expenses |
|
|
15,918 |
|
|
|
11,783 |
|
Operating loss |
|
|
(15,348 |
) |
|
|
(581 |
) |
Interest income (expense),
net |
|
|
(1,309 |
) |
|
|
(1,016 |
) |
Non-operating income
(expense), net |
|
|
— |
|
|
|
(22 |
) |
Net loss before income
taxes |
|
|
(16,657 |
) |
|
|
(1,619 |
) |
Income tax |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(16,657 |
) |
|
$ |
(1,619 |
) |
Net loss per share
attributable to holders of common stock: |
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(1.39 |
) |
|
$ |
(0.15 |
) |
Weighted-average shares outstanding: |
|
|
|
|
|
|
Weighted average shares outstanding - basic and diluted |
|
|
12,001,125 |
|
|
|
10,896,575 |
|
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