SAN DIEGO, Feb. 26, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the fourth quarter and
full-year ended December 31,
2018.
"In 2018 we delivered the steps necessary to position Arena for
long-term, sustainable growth by securing a strong cash position,
generating important data for our potential first- or best-in-class
compounds, and scaling the organization. We kicked off 2019 with
exciting data demonstrating etrasimod's long-term efficacy and
safety in an open-label extension trial, followed by the completion
of the global license deal with United Therapeutics," said
Amit D. Munshi, President and CEO of
Arena. "We are in a great position and we look forward to
continuing to build on the momentum of the last two years."
Pipeline Update
Etrasimod – Next generation, oral, selective
sphingosine-1-phosphate (S1P) receptor modulator in development for
the treatment of multiple immune and inflammatory diseases
- Ulcerative colitis (UC):
-
- Phase 3 planning ongoing
- Delivered positive open-label extension data of Phase 2 OASIS
trial
-
- Demonstrated clinical response and durable, long-term clinical
remission and a favorable long-term safety and tolerability
- Subjects that achieved clinical response or clinical remission
on 2 mg etrasimod at 12 weeks in OASIS demonstrated sustained
treatment effect over 46 weeks, with 93% experiencing sustained
clinical response and 75% experiencing sustained clinical
remission
- Crohn's disease (CD):
-
- Phase 2b/3 planning ongoing
- Atopic dermatitis (AD):
-
Olorinab – Oral, peripherally restricted, highly selective,
full agonist of cannabinoid receptor type 2 (CB2) in
development for the treatment of visceral pain associated with
gastrointestinal (GI) diseases
- Advancing into a Phase 2b
clinical program targeting the treatment of irritable bowel
syndrome (IBS) pain
APD418 – First-in-class, oral, calcium-independent
myofilament derepressor (CMD) for the treatment of decompensated
heart failure (DHF)
- Preclinical program advancing
Collaboration and License Agreements Update
- In January 2019, Arena and United
Therapeutics closed the Global License Agreement for ralinepag, a
potential best-in-class agent for the treatment of pulmonary
arterial hypertension. Arena received $800
million upfront and is eligible to receive up to
$400 million in regulatory milestone
payments plus low double-digit tiered royalties.
Corporate Update
- In December 2018, Arena appointed
Manmeet S. Soni as a non-executive
director
- In November 2018, Arena appointed
Robert Lisicki as Executive Vice
President and Chief Commercial Officer, and Paul K. Audhya, MD, MBA, as Senior Vice
President, Medical Affairs
- Arena announced expansion into the Boston area
Financial Update
Fourth Quarter 2018 Financial Results
- Revenues totaled $8.6 million, consisting of $6.9 million in collaboration revenue and
$1.8 million in royalty revenue
- Research and development expenses totaled $37.9 million
- General and administrative expenses totaled $15.4 million
- Income tax benefit related to a change in our deferred tax
asset valuation allowance was $110.3
million
- Net income attributable to stockholders of Arena was
$68.7 million, the basic earnings per
share was $1.39 per share and the
diluted earnings per share was $1.35
Full-Year 2018 Financial Results
- Revenues totaled $18.0 million, consisting of $11.4 million in collaboration revenue and
$6.6 million in royalty revenue
- Research and development expenses totaled $115.0 million
- General and administrative expenses totaled $47.7 million
- Income tax benefit related to a change in our deferred tax
asset valuation allowance was $110.3
million
- Net loss attributable to stockholders of Arena was $29.4 million, or $0.63 per share
At December 31, 2018, Arena's
cash, cash equivalents and investments balance was $528.0 million and approximately 49.4 million
shares of Arena common stock were outstanding. As of February 1, 2019 Arena's cash, cash equivalents
and investments balance was over $1.3
billion.
Conference Call & Webcast Information
Arena will host a conference call and live webcast with the
investment community today, Tuesday,
February 26, 2019, at 4:30 p.m.
EST to discuss the financial results and provide a corporate
update.
When: Tuesday, February 26, 2019,
at 4:30 p.m. EST
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 1855406
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's licensee, United Therapeutics, is evaluating
ralinepag in a Phase 3 program for pulmonary arterial hypertension
(PAH).
Arena has additional license agreements and partnerships,
including with 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
"eligible to," "potentially," "position for," "potential," "look
forward to," "intended for," "planning," "in development for,"
"targeting," "will," "driven to," "being evaluated for,"
"evaluating for," and "target," and include, without limitation,
statements about the following: design, initiation, enrollment,
results, data readouts, data presentations, and timing relating to
ongoing and intended preclinical and clinical 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; the strength of Arena's pipeline; Arena's
position and ability to execute on its programs; Arena's investment
community conference call and webcast; 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 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 Arena's Quarterly
Report on Form 10-Q for the quarter ended September 30, 2018, which was filed with the SEC
on November 8, 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, 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
|
|
Year ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
(unaudited)
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
Collaboration and
other revenue
|
$
6,878
|
|
$
14,193
|
|
$
11,402
|
|
$
19,632
|
|
Royalty
revenue
|
1,770
|
|
1,171
|
|
6,568
|
|
1,705
|
|
Total
revenues
|
8,648
|
|
15,364
|
|
17,970
|
|
21,337
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
Research &
development
|
37,890
|
|
20,711
|
|
115,029
|
|
70,988
|
|
General &
administrative
|
15,402
|
|
8,253
|
|
47,724
|
|
30,341
|
|
Litigation settlement
expense, net
|
—
|
|
—
|
|
—
|
|
11,975
|
|
Total
operating costs & expenses
|
53,292
|
|
28,964
|
|
162,753
|
|
113,304
|
|
|
|
|
|
|
|
|
|
|
Total interest
& other income (expense), net
|
3,090
|
|
(670)
|
|
5,949
|
|
(3,887)
|
|
Loss from continuing
operations before income taxes
|
(41,554)
|
|
(14,270)
|
|
(138,834)
|
|
(95,854)
|
|
Income tax
benefit
|
110,265
|
|
—
|
|
110,265
|
|
—
|
|
Income (loss) loss
from continuing operations
|
68,711
|
|
(14,270)
|
|
(28,569)
|
|
(95,854)
|
|
Income (loss) from
discontinued operations
|
—
|
|
315
|
|
(830)
|
|
3,122
|
|
Net income
(loss)
|
68,711
|
|
(13,995)
|
|
(29,399)
|
|
(92,732)
|
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
—
|
|
271
|
|
—
|
|
1,325
|
|
Net income (loss)
attributable to stockholders of Arena
|
$
68,711
|
|
$
(13,684)
|
|
$
(29,399)
|
|
$
(91,407)
|
|
|
|
|
|
|
|
|
|
|
Amounts
attributable to stockholders of Arena:
|
|
|
|
|
|
|
|
|
Income (loss)
from continuing operations
|
$
68,711
|
|
$
(13,999)
|
|
$
(28,569)
|
|
$
(94,529)
|
|
Income (loss)
from discontinued operations
|
—
|
|
315
|
|
(830)
|
|
3,122
|
|
|
$
68,711
|
|
$
(13,684)
|
|
$
(29,399)
|
|
$
(91,407)
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) attributable to stockholders of Arena per
share, basic:
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
$
1.39
|
|
$
(0.36)
|
|
$
(0.61)
|
|
$
(2.87)
|
|
Discontinued
operations
|
—
|
|
0.01
|
|
(0.02)
|
|
0.10
|
|
|
$
1.39
|
|
$
(0.35)
|
|
$
(0.63)
|
|
$
(2.77)
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) attributable to stockholders of Arena per
share, diluted:
|
|
|
|
|
|
|
|
|
Continuing
operations
|
$
1.35
|
|
$
(0.36)
|
|
$
(0.61)
|
|
$
(2.87)
|
|
Discontinued
operations
|
—
|
|
0.01
|
|
(0.02)
|
|
0.10
|
|
|
$
1.35
|
|
$
(0.35)
|
|
$
(0.63)
|
|
$
(2.77)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) attributable to stockholders of
Arena per share, basic:
|
49,409
|
|
39,268
|
|
47,041
|
|
32,990
|
|
Shares used in
calculating net income (loss) attributable to stockholders of
Arena per share, diluted:
|
50,826
|
|
39,268
|
|
47,041
|
|
32,990
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
December 31,
2018
|
|
December 31,
2017
|
|
1
|
|
1
|
Assets
|
|
|
|
Cash &
cash equivalents
|
$ 161,037
|
|
$ 158,837
|
Accounts
receivable
|
5,086
|
|
2,357
|
Deferred tax
assets
|
110,333
|
|
—
|
Insurance
recovery receivable
|
—
|
|
12,025
|
Prepaid
expenses & other current assets
|
10,008
|
|
2,681
|
Total
available-for-sale investments
|
367,006
|
|
112,482
|
Land, property
& equipment, net
|
23,114
|
|
30,131
|
Other
non-current assets
|
10,319
|
|
3,622
|
Assets of
disposal group held for sale
|
—
|
|
17,140
|
Total
assets
|
$ 686,903
|
|
$ 339,275
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
Accounts
payable & accrued liabilities
|
$
26,635
|
|
$
15,622
|
Accrued
litigation settlement
|
—
|
|
24,000
|
Total deferred
revenues
|
—
|
|
2,177
|
Total lease
financing obligations & other long-term liabilities
|
54,010
|
|
62,737
|
Liabilities of
disposal group held for sale
|
—
|
|
27,595
|
Total
stockholders' equity
|
606,258
|
|
207,144
|
Total
liabilities & stockholders' equity
|
$ 686,903
|
|
$ 339,275
|
|
1 The Condensed Consolidated
Balance Sheet Data has been derived from the audited financial
statements as of that date.
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-provides-corporate-update-and-reports-fourth-quarter-and-full-year-2018-financial-results-300802595.html
SOURCE Arena Pharmaceuticals, Inc.