SAN DIEGO, May 8, 2018 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the first quarter ended
March 31, 2018.
"After delivering positive Phase 2 data on our most advanced
compounds, etrasimod and ralinepag, we are now focused on
initiating multiple Phase 3 studies for both programs in addition
to a range of Phase 2 studies to expand the utility of these
compounds," said Amit D. Munshi,
President and CEO of Arena. "In addition to executing on the trials
for these potentially best-in-class candidates, we plan for
additional program catalysts as we move through 2018. The next 12
to 18 months promise to be as exciting as the last."
Pipeline Update
Etrasimod – Oral, next generation, selective
sphingosine-1-phosphate (S1P) receptor modulator intended for the
potential treatment of multiple immune and inflammatory
diseases
- Ulcerative colitis (UC):
-
- Positive Phase 2 data achieved in March
2018
- Intend to initiate Phase 3 program
- Crohn's disease (CD):
-
- Planning development path forward
- Primary biliary cholangitis (PBC):
-
- Phase 2 trial currently enrolling patients
Ralinepag – Oral, next generation, selective prostacyclin
receptor agonist intended for the treatment of pulmonary arterial
hypertension (PAH)
- Expect to initiate two standalone, Phase 3 registrational
studies, as well as additional differentiation studies, in H2
2018
Olorinab (formerly APD371) – Oral, peripherally restricted,
full agonist of the cannabinoid 2 (CB2) receptor intended for the
potential treatment of visceral pain, specifically pain associated
with Crohn's disease
- Plan to complete enrollment in Phase 2 trial in Q2 2018, with
results expected in Q3 2018
Collaborations Update
- In April 2018, Arena announced a
licensing agreement with Outpost Medicine on a preclinical compound
for the treatment of genitourinary disorders
Corporate Update
- On March 31, 2018, Arena
completed the sale of its manufacturing operations located in
Zofingen, Switzerland to
Siegfried
- On March 26, 2018, Arena closed a
public offering that raised aggregate net proceeds of $383.1 million through the issuance of
approximately 9.8 million shares
Financial Update
First Quarter 2018 Financial Results
- Revenues totaled $1.8 million,
consisting of $1.0 million in
collaboration revenue, and $0.7
million in royalty revenue
- Research and development expenses totaled $21.6 million
- General and administrative expenses totaled $11.2 million
- Net loss attributable to stockholders of Arena was $32.0 million, or $0.80 per share
At March 31, 2018, Arena's cash,
cash equivalents and investments balance was $629.1 million and approximately 49.2 million
shares of Arena common stock were outstanding.
Conference Call & Webcast Information
Arena will
host a conference call and live webcast with the investment
community today, Tuesday, May 8,
2018, at 4:30 p.m. EDT to
discuss the financial results and provide a corporate update.
When: Tuesday, May 8, 2018, at
4:30 p.m. EDT
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 7698222
Please join the conference call at least 10 minutes early to
register. You can access the live webcast under the investor
relations section of Arena's website at: www.arenapharm.com.
A replay of the conference call will be archived under the investor
relations section of Arena's website for 30 days shortly after the
call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is
focused on delivering novel, transformational medicines with
optimized pharmacology and pharmacokinetics to patients globally.
Arena's proprietary pipeline includes multiple potentially first-
or best-in-class programs with broad clinical utility. The most
advanced investigational clinical programs are ralinepag (APD811),
which will be commencing a Phase 3 program for pulmonary arterial
hypertension (PAH), and etrasimod (APD334), which will be
commencing a Phase 3 program for ulcerative colitis (UC) and a
program in Crohn's Disease (CD), and which has potential utility
for a broad range of immune and inflammatory conditions. Arena is
also evaluating olorinab (APD371) in Phase 2 for the treatment of
visceral pain associated with Crohn's disease, as well as other
drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest
Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries),
Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer
Ingelheim International GmbH (undisclosed target - preclinical),
Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai
Co., Ltd. and Eisai Inc. (BELVIQ® - marketed
product).
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. Such forward-looking statements may be
identified by words such as "plan," "expect," "focused on,"
"potential," "promise," "intended," "intend," "planning,"
"expected," "will," and "potentially," and include, without
limitation, statements about initiation, enrollment, results, data
readouts and timing relating to ongoing and intended clinical
trials; the potential of Arena's drug candidates; Arena's
investment community conference call and webcast; and Arena's
focus, goals, strategy, clinical programs, and collaborators. For
such statements, Arena claims the protection of the Private
Securities Litigation Reform Act of 1995. Actual events or results
may differ materially from Arena's expectations. Factors that could
cause actual results to differ materially from the forward-looking
statements include, but are not limited to, the following:
the risk that we may need additional funds to advance all of our
programs, and you and others may not agree with the manner we
allocate our resources; risks related to developing and
commercializing drugs; enrolling patients in our ongoing and
intended clinical trials is competitive and challenging; clinical
trials and other studies may not proceed at the time or in the
manner expected or at all; the timing and outcome of research,
development and regulatory review is uncertain, and our drug
candidates may not advance in development or be approved for
marketing; risks and uncertainties relating to cash and revenues
that may be generated from product sales or other sources,
including the impact of competition; the risk that Arena's revenues
are based in part on estimates, judgment and accounting policies,
and incorrect estimates or disagreement regarding estimates or
accounting policies may result in changes to Arena's guidance or
previously reported results; risks related to unexpected or
unfavorable new data; nonclinical and clinical data is voluminous
and detailed, and regulatory agencies may interpret or weigh the
importance of data differently and reach different conclusions than
Arena or others, request additional information, have additional
recommendations or change their guidance or requirements before or
after approval; results of clinical trials and other studies are
subject to different interpretations and may not be predictive of
future results; topline data may not accurately reflect the
complete results of a particular study or trial; satisfactory
resolution of litigation or other disagreements with others;
government and third-party payor actions, including relating to
reimbursement and pricing; risks related to relying on
collaborative arrangements; the entry into or modification or
termination of collaborative arrangements; and Arena's and third
parties' intellectual property rights. Additional factors that
could cause actual results to differ materially from those stated
or implied by Arena's forward-looking statements are disclosed in
Arena's filings with the Securities and Exchange Commission (SEC),
including but not limited to our Annual Report on Form 10-K for the
year ended December 31, 2017, which
was filed with the SEC on March 14,
2018. These forward-looking statements represent Arena's
judgment as of the time of this release. Arena disclaims any intent
or obligation to update these forward-looking statements, other
than as may be required under applicable law.
Corporate Contact:
Kevin R.
Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena
Pharmaceuticals, Inc. Condensed Consolidated Statements of
Operations (In
thousands, except per share amounts)
|
|
Three months
ended
|
|
March 31,
|
|
2018
|
|
2017
|
|
(unaudited)
|
|
(unaudited)
|
Revenues
|
|
|
|
Collaboration and
other revenue
|
$
1,028
|
|
$
1,660
|
Royalty
revenue
|
727
|
|
—
|
Total
revenues
|
1,755
|
|
1,660
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
Research &
development
|
21,573
|
|
15,344
|
General &
administrative
|
11,151
|
|
7,520
|
Total
operating costs & expenses
|
32,724
|
|
22,864
|
|
|
|
|
Total interest
& other expense, net
|
(164)
|
|
(1,347)
|
Loss from continuing
operations
|
(31,133)
|
|
(22,551)
|
Income (loss) from
discontinued operations
|
(830)
|
|
54
|
Net loss
|
(31,963)
|
|
(22,497)
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
—
|
|
444
|
Net loss attributable
to stockholders of Arena
|
$
(31,963)
|
|
$
(22,053)
|
|
|
|
|
Amounts
attributable to stockholders of Arena:
|
|
|
|
Loss from
continuing operations
|
$
(31,133)
|
|
$
(22,107)
|
Income (loss)
from discontinued operations
|
(830)
|
|
54
|
|
$
(31,963)
|
|
$
(22,053)
|
|
|
|
|
Net loss
attributable to stockholders of Arena per share, basic and
diluted:1
|
|
|
|
Continuing operations
|
$
(0.78)
|
|
$
(0.90)
|
Discontinued operations
|
(0.02)
|
|
—
|
|
$
(0.80)
|
|
$
(0.90)
|
|
|
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share, basic and diluted1
|
39,996
|
|
24,482
|
|
1
Comparative period data adjusted to give effect to Arena's June
2017 1-for-10 reverse stock split.
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2018
|
|
December 31,
2017
|
|
|
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 516,141
|
|
$ 158,837
|
|
Accounts
receivable
|
3,306
|
|
2,357
|
|
Insurance
recovery receivable
|
12,025
|
|
12,025
|
|
Prepaid
expenses & other current assets
|
5,409
|
|
2,681
|
|
Total
available for sale investments
|
112,980
|
|
112,482
|
|
Land, property
& equipment, net
|
29,507
|
|
30,131
|
|
Other
non-current assets
|
6,100
|
|
3,622
|
|
Total assets
of disposal group held for sale
|
—
|
|
17,140
|
|
Total
assets
|
$ 685,468
|
|
$ 339,275
|
|
|
|
|
|
|
Liabilities &
Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$
13,928
|
|
$
15,622
|
|
Accrued
litigation settlement
|
24,000
|
|
24,000
|
|
Total deferred
revenues
|
1,615
|
|
2,177
|
|
Total lease
financing obligations & other long-term liabilities
|
61,790
|
|
62,737
|
|
Total
liabilities of disposal group held for sale
|
—
|
|
27,595
|
|
Total
equity
|
584,135
|
|
207,144
|
|
Total
liabilities & equity
|
$ 685,468
|
|
$ 339,275
|
|
|
1
The Condensed Consolidated Balance Sheet Data has been derived from
the audited financial statements as of that date.
|
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SOURCE Arena Pharmaceuticals, Inc.