SAN DIEGO, Aug. 7, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the second quarter ended
June 30, 2019.
"Arena is off to a strong 2019 and we remain highly focused on
achieving several key clinical and regulatory goals. We are
excited to have recently initiated two important trials, the
etrasimod Phase 3 ELEVATE UC 52 trial and the olorinab Phase 2
CAPTIVATE trial. We will provide further detail around the
CAPTIVATE trial on today's call," said Amit
D. Munshi, President and CEO of Arena. "Execution is key for
Arena this year, following several positive data readouts and
strategic transactions across our pipeline. We look forward
to demonstrating the potential benefits and differentiation of our
first- or best-in-class assets as we continue to deliver these
exciting milestones."
Pipeline Update
Etrasimod – Next generation, once-daily, oral, selective
sphingosine-1-phosphate (S1P) receptor modulator in development for
the treatment of multiple immune and inflammatory diseases
- Ulcerative colitis (UC): The global Phase 3 ELEVATE UC
registrational program will consist of two key trials to evaluate
etrasimod 2 mg in subjects with moderately to severely active
UC
-
- ELEVATE UC 52, a treat-through trial with a 12-week
induction period followed by 40 weeks of maintenance; trial was
initiated in June
- ELEVATE UC 12, a 12-week trial, which is expected to initiate
at a later date to optimize speed to market
- Crohn's disease (CD):
-
- CULTIVATE Phase 2b/3 program
planning ongoing
- Atopic dermatitis (AD):
-
- ADVISE Phase 2b trial planning
ongoing
Olorinab – Oral, peripherally acting, highly selective, full
agonist of cannabinoid type 2 receptor (CB2) in
development for the treatment of visceral pain associated with
gastrointestinal (GI) diseases
- Abdominal pain associated with irritable bowel syndrome
(IBS):
-
- CAPTIVATE is a Phase 2b
trial to evaluate three dose levels of olorinab for 12-weeks in
approximately 240 subjects experiencing abdominal pain associated
with IBS, including IBS with constipation (IBS-C) and IBS with
diarrhea (IBS-D). The primary endpoint will measure the
improvement from baseline in the weekly Average Abdominal Pain
Scale (AAPS); trial was initiated in July
Etrasimod and olorinab are investigational compounds that are
not approved for any use in any country.
Financial Update
Second Quarter 2019 Financial Results
- Revenues totaled $1.0 million,
primarily consisting of $0.9 million
of royalty revenue
- Research and development expenses totaled $51.2 million, including $7.0 million related to non-cash share-based
compensation
- General and administrative expenses totaled $18.4 million, including $6.4 million related to non-cash share-based
compensation
- Net loss was $61.4 million or
$1.24 per share
At June 30, 2019, Arena's cash,
cash equivalents and investments balance was over $1.2 billion and approximately 49.8 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, Wednesday, August 7,
2019, at 4:30 PM EDT to
discuss the financial results and provide a corporate update.
When: Wednesday, August 7, 2019,
at 4:30 PM EDT
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 4673427
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 driven to deliver novel, transformational
medicines with optimized pharmacology and pharmacokinetics to
patients globally. Arena's proprietary pipeline includes multiple
potentially first- or best-in-class assets with broad clinical
utility. Etrasimod (APD334), with potential utility in a broad
range of immune and inflammatory conditions, is being evaluated in
late-stage clinical programs in ulcerative colitis (UC) and Crohn's
disease (CD), as well as in programs for other indications such as
atopic dermatitis. Arena is also evaluating olorinab (APD371) in a
Phase 2 program for gastrointestinal pain. Arena continues to
assess other earlier research and development stage drug
candidates, including APD418 for decompensated heart failure.
Arena has additional license agreements and partnerships,
including with United Therapeutics (ralinepag in a Phase 3 program
for pulmonary arterial hypertension), Everest Medicines Limited
(etrasimod in Greater China and
select Asian countries), 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 "expected," "potential," "plan," "in
development for," "will," "driven to," "evaluate," "look forward
to," and include, without limitation, statements about the
following: design, initiation, enrollment, data and results, and
timing relating to ongoing and intended trials; the potential of
Arena's drug candidates, including to be first- or best-in-class,
have optimized pharmacology and pharmacokinetics, have broad
clinical utility, and be delivered to patients globally; Arena's
position and ability to execute on its programs; Arena's drive and
focus; and the potential of Arena's assets, programs, licenses, and
collaborations. 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: 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
Arena's drug candidates may not advance in development or be
approved for marketing; enrolling patients in Arena's ongoing and
intended clinical trials is competitive and challenging; risks
related to developing and commercializing drugs; Arena may need
additional funds to advance all of its programs, and you and others
may not agree with the manner Arena allocates its resources; risks
and uncertainties relating to cash and revenues that may be
generated from product sales or other sources, including the impact
of competition; 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 licenses or collaborative arrangements,
including lack of control and potential disputes; the entry into or
modification or termination of licenses or 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 Arena's Annual Report on Form 10-K for the year ended
December 31, 2018, which was filed
with the SEC on February 28, 2019,
and our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2019, which was filed with
the SEC on May 9, 2019. 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, MD
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
|
|
|
Six months
ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Therapeutics
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
800,000
|
|
|
$
|
—
|
|
Royalty
revenue
|
|
|
941
|
|
|
|
861
|
|
|
|
1,914
|
|
|
|
1,588
|
|
Collaboration and
other revenue
|
|
|
81
|
|
|
|
3,133
|
|
|
|
165
|
|
|
|
4,161
|
|
Total
revenues
|
|
|
1,022
|
|
|
|
3,994
|
|
|
|
802,079
|
|
|
|
5,749
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research &
development
|
|
|
51,211
|
|
|
|
26,755
|
|
|
|
96,607
|
|
|
|
48,328
|
|
General &
administrative
|
|
|
18,367
|
|
|
|
10,405
|
|
|
|
34,945
|
|
|
|
21,556
|
|
Transaction
costs
|
|
|
—
|
|
|
|
—
|
|
|
|
14,573
|
|
|
|
—
|
|
Total operating costs
& expenses
|
|
|
69,578
|
|
|
|
37,160
|
|
|
|
146,125
|
|
|
|
69,884
|
|
Income (loss) from
operations
|
|
|
(68,556)
|
|
|
|
(33,166)
|
|
|
|
655,954
|
|
|
|
(64,135)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest &
other income (expense), net
|
|
|
7,153
|
|
|
|
1,333
|
|
|
|
13,110
|
|
|
|
1,169
|
|
Income (loss) from
continuing operations before income taxes
|
|
|
(61,403)
|
|
|
|
(31,833)
|
|
|
|
669,064
|
|
|
|
(62,966)
|
|
Income tax
provision
|
|
|
—
|
|
|
|
—
|
|
|
|
(110,333)
|
|
|
|
—
|
|
Income (loss) from
continuing operations
|
|
|
(61,403)
|
|
|
|
(31,833)
|
|
|
|
558,731
|
|
|
|
(62,966)
|
|
Loss from
discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(830)
|
|
Net income
(loss)
|
|
$
|
(61,403)
|
|
|
$
|
(31,833)
|
|
|
$
|
558,731
|
|
|
$
|
(63,796)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share, basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(1.24)
|
|
|
$
|
(0.65)
|
|
|
$
|
11.27
|
|
|
$
|
(1.41)
|
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.02)
|
|
|
|
$
|
(1.24)
|
|
|
$
|
(0.65)
|
|
|
$
|
11.27
|
|
|
$
|
(1.43)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share, diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(1.24)
|
|
|
$
|
(0.65)
|
|
|
$
|
10.86
|
|
|
$
|
(1.41)
|
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.02)
|
|
|
|
$
|
(1.24)
|
|
|
$
|
(0.65)
|
|
|
$
|
10.86
|
|
|
$
|
(1.43)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share, basic:
|
|
|
49,653
|
|
|
|
49,263
|
|
|
|
49,566
|
|
|
|
44,655
|
|
Shares used in
calculating net income (loss) per share, diluted:
|
|
|
49,653
|
|
|
|
49,263
|
|
|
|
51,459
|
|
|
|
44,655
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2019
|
|
December 31,
2018
|
|
|
(unaudited)
|
|
(unaudited)1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$
200,059
|
|
$ 161,037
|
|
Accounts
receivable
|
1,824
|
|
5,086
|
|
Deferred tax
assets
|
—
|
|
110,333
|
|
Prepaid
expenses & other current assets
|
20,778
|
|
10,008
|
|
Total
available-for-sale investments
|
1,021,855
|
|
367,006
|
|
Land, property
& equipment, net
|
23,493
|
|
23,114
|
|
Other
non-current assets
|
16,526
|
|
10,319
|
|
Total
assets
|
$
1,284,535
|
|
$ 686,903
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 24,637
|
|
$
26,635
|
|
Total lease
financing obligations & other long-term liabilities
|
58,909
|
|
54,010
|
|
Total
stockholders' equity
|
1,200,989
|
|
606,258
|
|
Total
liabilities & stockholders' equity
|
$
1,284,535
|
|
$ 686,903
|
|
|
|
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.