SAN DIEGO, Nov. 7, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the third quarter ended
September 30, 2019.
"Arena continues to have a strong 2019 and we remain highly
focused on achieving several key clinical and regulatory goals.
This year we have initiated multiple important trials, including
the etrasimod Phase 3 ELEVATE UC 52 trial, the olorinab Phase 2
CAPTIVATE trial, and the etrasimod Phase 2 ADVISE trial. We remain
on track to initiate the etrasimod Ph 2/3 program in Crohn's
disease and to file an IND for APD418 this year," said Amit D. Munshi, President and CEO of Arena. "We
look forward to delivering on our exciting milestones and will
continue to be bold and creative as we scale our enterprise to
advance our pipeline."
Pipeline Update
Etrasimod – Next generation, once-daily, oral, selective
sphingosine 1-phosphate (S1P) receptor modulator in development for
the treatment of multiple immune-mediated 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 Phase 3 trial ongoing
• ELEVATE UC 12 Phase 3
trial expected to initiate at a later date to optimize speed to
market
- Crohn's disease (CD):
• Phase 2b/3 program planning ongoing, on track to
initiate this year
- Atopic dermatitis (AD):
• ADVISE Phase
2b trial initiated
Olorinab – Oral, peripherally acting, highly selective, full
agonist of cannabinoid receptor 2 (CB2) in development
for the treatment of visceral pain associated with gastrointestinal
(GI) diseases
- Abdominal pain associated with irritable bowel syndrome
(IBS):
• CAPTIVATE Phase
2b trial ongoing
APD418 – First-in-Class Beta-3 AdrR Antagonist and Cardiac
Myotrope in preclinical development for the treatment of
decompensated heart failure (DHF)
- Preclinical program advancing, on track to file IND this
year
Etrasimod, olorinab and APD418 are investigational compounds
that are not approved for any use in any country.
Financial Update
Third Quarter 2019 Financial Results
- Revenues totaled $1.4 million,
primarily consisting of $0.8 million
of royalty revenue
- Research and development expenses totaled $60.3 million, including $6.7 million related to non-cash share-based
compensation
- General and administrative expenses totaled $20.4 million, including $6.6 million related to non-cash share-based
compensation
- Net loss was $72.9 million or
$1.46 per share
At September 30, 2019, Arena's
cash, cash equivalents and investments balance was approximately
$1.2 billion and approximately 50.0
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, Thursday, November 7,
2019, at 4:30 PM EST to
discuss the financial results and provide a corporate update.
When: Thursday, November 7, 2019,
at 4:30 PM EST
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 2598434
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 to patients globally. Arena's
proprietary pipeline includes multiple potentially first- or
best-in-class assets with broad clinical utility. Arena is
evaluating etrasimod (APD334) in a broad range of
immune-mediated inflammatory diseases, including in later-stage
programs in inflammatory bowel disease (IBD), a Phase 2 program in
atopic dermatitis (AD), and in programs for other indications.
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 (OP-352 – Phase 1), 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 "focused on," "goals," "on track to,"
"look forward to," "will," "in development for," "expected,"
"planning," "driven to," "potentially," and "evaluate," and
include, without limitation, statements about the following:
Arena's planned conference call and webcast with the investment
community; design, initiation, enrollment, data and results, and
timing relating to ongoing and intended programs and studies,
including the timing of planned IND filing and initiation of
planned clinical trials; the potential of Arena's drug candidates,
including to be first- or best-in-class or transformational, have
optimized pharmacology or 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 partnerships. 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 Arena's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2019, which
was filed with the SEC on August 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
|
|
|
Nine months
ended
|
|
|
September
30,
|
|
|
September
30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
(unaudited)
|
|
|
(unaudited)
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Therapeutics
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
800,000
|
|
|
$
|
—
|
Royalty
revenue
|
|
|
811
|
|
|
|
3,210
|
|
|
|
2,725
|
|
|
|
4,798
|
Collaboration and
other revenue
|
|
|
539
|
|
|
|
363
|
|
|
|
704
|
|
|
|
4,524
|
Total
revenues
|
|
|
1,350
|
|
|
|
3,573
|
|
|
|
803,429
|
|
|
|
9,322
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research &
development
|
|
|
60,257
|
|
|
|
28,811
|
|
|
|
156,864
|
|
|
|
77,139
|
General &
administrative
|
|
|
20,428
|
|
|
|
10,766
|
|
|
|
55,373
|
|
|
|
32,322
|
Transaction
costs
|
|
|
—
|
|
|
|
—
|
|
|
|
14,573
|
|
|
|
—
|
Total operating costs
& expenses
|
|
|
80,685
|
|
|
|
39,577
|
|
|
|
226,810
|
|
|
|
109,461
|
Income (loss) from
operations
|
|
|
(79,335)
|
|
|
|
(36,004)
|
|
|
|
576,619
|
|
|
|
(100,139)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest &
other income (expense), net
|
|
|
6,470
|
|
|
|
1,690
|
|
|
|
19,580
|
|
|
|
2,859
|
Income (loss) from
continuing operations before income taxes
|
|
|
(72,865)
|
|
|
|
(34,314)
|
|
|
|
596,199
|
|
|
|
(97,280)
|
Income tax
provision
|
|
|
—
|
|
|
|
—
|
|
|
|
(110,333)
|
|
|
|
—
|
Income (loss) from
continuing operations
|
|
|
(72,865)
|
|
|
|
(34,314)
|
|
|
|
485,866
|
|
|
|
(97,280)
|
Loss from
discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(830)
|
Net income
(loss)
|
|
$
|
(72,865)
|
|
|
$
|
(34,314)
|
|
|
$
|
485,866
|
|
|
$
|
(98,110)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share, basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(1.46)
|
|
|
$
|
(0.70)
|
|
|
$
|
9.78
|
|
|
$
|
(2.10)
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.02)
|
|
|
$
|
(1.46)
|
|
|
$
|
(0.70)
|
|
|
$
|
9.78
|
|
|
$
|
(2.12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share, diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(1.46)
|
|
|
$
|
(0.70)
|
|
|
$
|
9.39
|
|
|
$
|
(2.10)
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.02)
|
|
|
$
|
(1.46)
|
|
|
$
|
(0.70)
|
|
|
$
|
9.39
|
|
|
$
|
(2.12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share, basic:
|
|
|
49,864
|
|
|
|
49,368
|
|
|
|
49,667
|
|
|
|
46,243
|
Shares used in
calculating net income (loss) per share, diluted:
|
|
|
49,864
|
|
|
|
49,368
|
|
|
|
51,763
|
|
|
|
46,243
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2019
|
|
December 31,
2018
|
|
|
(unaudited)
|
|
(unaudited)1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 170,884
|
|
$ 161,037
|
|
Accounts
receivable
|
1,696
|
|
5,086
|
|
Deferred tax
assets
|
—
|
|
110,333
|
|
Prepaid
expenses & other current assets
|
20,930
|
|
10,008
|
|
Total
available-for-sale investments
|
1,002,851
|
|
367,006
|
|
Land, property
& equipment, net
|
23,698
|
|
23,114
|
|
Other
non-current assets
|
21,989
|
|
10,319
|
|
Total
assets
|
$
1,242,048
|
|
$ 686,903
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 33,140
|
|
$
26,635
|
|
Total lease
financing obligations & other long-term liabilities
|
62,702
|
|
54,010
|
|
Total
stockholders' equity
|
1,146,206
|
|
606,258
|
|
Total
liabilities & stockholders' equity
|
$
1,242,048
|
|
$ 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.