SAN DIEGO, May 8, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the first quarter ended
March 31, 2019.
"We are continuing to make significant progress on advancing our
internally developed potential first- or best-in-class compounds,"
said Amit D. Munshi, President and
CEO of Arena. "Today, we are excited to share additional detail
around the ELEVATE UC program for etrasimod in ulcerative colitis
that we plan to initiate mid-year. With the exciting data shown to
date, demonstrating etrasimod's sustained, long-term efficacy and
safety, we hope to address the significant unmet need that still
remains in inflammatory bowel disease, where 60-80% of patients are
either not receiving or failing a biologic."
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 etrasimod global Phase 3 ELEVATE
UC registrational program aims to include over 40 countries and
will consist of two key trials to evaluate etrasimod 2 mg in
subjects with moderately to severely active ulcerative colitis.
Firstly, ELEVATE UC 52, a treat-through trial with a 12-week
induction period followed by 40 weeks of maintenance in
approximately 370 subjects, is expected to initiate mid-year.
Secondly, ELEVATE UC 12, a 12-week induction period trial in
approximately 330 subjects, is expected to initiate at a later date
to optimize time to market. We plan to conduct additional studies
to provide evidence of differentiation for health care providers
and payers.
- Crohn's disease (CD):
-
- Phase 2b-3 planning ongoing
- Atopic dermatitis (AD):
-
Olorinab – Oral, peripherally active, highly selective, full
agonist of cannabinoid receptor type 2 (CB2) in
development for the treatment of visceral pain associated with
gastrointestinal (GI) diseases
- Irritable bowel syndrome (IBS) pain
-
- Phase 2b planning ongoing
APD418 – First-in-class, calcium-independent myofilament
derepressor (CMD) in preclinical development for the treatment of
decompensated heart failure (DHF)
- Preclinical program advancing
Etrasimod, olorinab and APD418 are investigational compounds
that are not approved for any use in any country.
Financial Update
First Quarter 2019 Financial Results
- Revenues totaled $801.1 million,
consisting of $800.0 million of
revenue from the United Therapeutics upfront payment ($785.4 million net of costs associated with the
transaction) and $1.0 million of
royalty revenue.
- Research and development expenses totaled $45.4 million, including $3.2 million related to ralinepag development
program incurred prior to the transition to United Therapeutics and
$6.7 million related to non-cash
share-based compensation
- General and administrative expenses totaled $16.6 million, including $6.3 million related to non-cash share-based
compensation
- The Company recorded a tax provision of $110.3 million as a result of utilizing the
deferred tax assets that were recorded in the fourth quarter of
2018
- Net income attributable to stockholders of Arena was
$620.1 million, the basic earnings
per share was $12.53 per share and
the diluted earnings per share was $12.10
At March 31, 2019, Arena's cash,
cash equivalents and investments balance was approximately
$1.3 billion and approximately 49.5
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, May
8, 2019, at 4:30 PM EDT to
discuss the financial results and provide a corporate update.
When: Wednesday, May 8, 2019, at
4:30 PM EDT
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 5285824
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, 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," "targeting,"
"will," "driven to," "evaluated" or "evaluating," 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 or
transformative, 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 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.
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
|
|
March 31,
|
|
2019
|
|
2018
|
|
(unaudited)
|
|
(unaudited)
|
Revenues
|
|
|
|
United Therapeutics
revenue
|
$
800,000
|
|
$
—
|
Royalty
revenue
|
973
|
|
727
|
Collaboration and
other revenue
|
84
|
|
1,028
|
Total
revenues
|
801,057
|
|
1,755
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
Research &
development
|
45,396
|
|
21,573
|
General &
administrative
|
16,578
|
|
11,151
|
Transaction
costs
|
14,573
|
|
—
|
Total
operating costs & expenses
|
76,547
|
|
32,724
|
Income (loss)
from operations
|
724,510
|
|
(30,969)
|
|
|
|
|
Total interest
& other income (expense), net
|
5,957
|
|
(164)
|
Income (loss) from
continuing operations before income taxes
|
730,467
|
|
(31,133)
|
Income tax
provision
|
(110,333)
|
|
—
|
Income (loss) from
continuing operations
|
620,134
|
|
(31,133)
|
Loss from
discontinued operations
|
—
|
|
(830)
|
Net income
(loss)
|
620,134
|
|
(31,963)
|
|
|
|
|
Net income (loss)
per share, basic:
|
|
|
|
Continuing operations
|
$
12.53
|
|
$
(0.78)
|
Discontinued operations
|
—
|
|
(0.02)
|
|
$
12.53
|
|
$
(0.80)
|
|
|
|
|
Net income (loss)
per share, diluted:
|
|
|
|
Continuing operations
|
$
12.10
|
|
$
(0.78)
|
Discontinued operations
|
—
|
|
(0.02)
|
|
$
12.10
|
|
$
(0.80)
|
|
|
|
|
Shares used in
calculating net income (loss) per share, basic
|
49,478
|
|
39,996
|
Shares used in
calculating net income (loss) per share, diluted
|
51,255
|
|
39,996
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
|
(unaudited)
|
|
(unaudited)1
|
Assets
|
|
|
|
Cash &
cash equivalents
|
$ 727,404
|
|
$ 161,037
|
Accounts
receivable
|
3,083
|
|
5,086
|
Deferred tax
assets
|
—
|
|
110,333
|
Prepaid
expenses & other current assets
|
18,520
|
|
10,008
|
Total
available-for-sale investments
|
542,265
|
|
367,006
|
Land, property
& equipment, net
|
23,445
|
|
23,114
|
Other
non-current assets
|
15,336
|
|
10,319
|
Total
assets
|
$
1,330,053
|
|
$ 686,903
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
Accounts
payable & accrued liabilities
|
$
28,299
|
|
$
26,635
|
Total lease
financing obligations & other long-term liabilities
|
58,317
|
|
54,010
|
Total
stockholders' equity
|
1,243,437
|
|
606,258
|
Total
liabilities & stockholders' equity
|
$
1,330,053
|
|
$ 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.