SAN DIEGO, May 9, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA), a biopharmaceutical company
focused on developing novel, small molecule drugs across multiple
therapeutic areas, today provided a corporate update and reported
financial results for the first quarter ended March 31, 2017.
"With important clinical data expected over the rest of the
year, 2017 promises to be an exciting time for Arena as we focus on
driving long-term shareholder value through the continued
advancement of our innovative pipeline," said Amit Munshi, President and CEO of Arena. "Our
focus for the coming months is to continue to execute across all
aspects of our business, including generating top-line readouts for
our three proprietary Phase 2 compounds, beginning with ralinepag
in July."
Pipeline Update
Ralinepag – oral, selective, next generation IP receptor
agonist targeting the prostacyclin pathway for the potential
treatment of pulmonary arterial hypertension (PAH)
- Phase 2 trial in PAH
-
- Data readout expected in July
2017
- Phase 1 pharmacokinetic and pharmacodynamic trial comparing
current twice-daily formulation with a new once-daily formulation
in healthy volunteers
-
- Data readout expected in current quarter
Etrasimod – orally available next generation
sphingosine-1-phosphate (S1P) receptor modulator for the potential
treatment of a number of autoimmune diseases
- Phase 2 trial in ulcerative colitis (UC)
-
- Data readout expected by year-end 2017
- Phase 2 trial in dermatological extraintestinal manifestations
(EIM) in patients with inflammatory bowel disease (IBD)
-
- Trial currently enrolling patients
- Phase 2 trial in pyoderma gangrenosum (PG)
-
- Trial currently enrolling patients
- Phase 2 trial in primary biliary cholangitis (PBC)
-
- Intend to initiate clinical study in 2017
APD371 – orally available full agonist of the cannabinoid-2
receptor for the potential treatment of visceral pain, specifically
pain associated with Crohn's disease
- Phase 2 trial currently enrolling patients
Corporate Update
- In March 2017, Arena appointed
Dr. Preston Klassen, M.D., M.H.S. as
Executive Vice President, Research and Development and Chief
Medical Officer
- Closed a public offering that raised aggregate net proceeds of
$74.6 million through the issuance of
69,000,000 shares of common stock
Financial Update
First Quarter 2017 Financial Results
- Revenues totaled $6.6 million,
including $2.7 million in net product
sales of BELVIQ, $1.5 million in
manufacturing support payments from Eisai, and approximately
$1.1 million of revenue associated
with upfront payments from Boehringer Ingelheim and Axovant
collaborations
- Research and development expenses totaled $15.5 million
- General and administrative expenses totaled $8.2 million
- Net loss was $22.5 million, or
$0.09 per share
At March 31, 2017, cash and cash
equivalents totaled $79.5 million,
and approximately 248 million shares of Arena common stock were
outstanding. This does not include the $75.5
million in net proceeds received through April 21, 2017, for issuing and selling
approximately 70 million shares of common stock under the equity
financing and the Company's at-the-market sales agreement.
Conference Call & Webcast Information
The Company
will host a conference call and live webcast with the investment
community today, Tuesday, May 9,
2017, at 4:30 p.m. ET to
discuss the financial results and provide a corporate update.
When: May 9, 2017, 4:30 p.m. ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 8556129
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 a
biopharmaceutical company focused on developing novel, small
molecule drugs with optimized receptor pharmacology designed to
deliver broad clinical utility across multiple therapeutic areas.
Our proprietary pipeline includes potentially first- or
best-in-class programs for which we own global commercial rights.
Our three most advanced investigational clinical programs are
ralinepag (APD811) in Phase 2 evaluation for pulmonary arterial
hypertension (PAH), etrasimod (APD334) in Phase 2 evaluation for
multiple autoimmune indications, and APD371 in Phase 2 evaluation
for the treatment of pain associated with Crohn's disease. In
addition, Arena has collaborations with the following
pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc.
(commercial stage), Axovant Sciences (Phase 2 candidate), and
Boehringer Ingelheim International GmbH (preclinical
candidate).
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 include
statements about the importance of clinical data, the promise of
2017, long-term value creation, advancement of our pipeline,
expected results, top-line or data readouts, and timing relating to
ongoing or intended clinical trials; and Arena's focus, goals,
strategy and clinical programs. 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 timing and outcome of
research, development and regulatory review is uncertain; we expect
to need additional funds to advance all of our programs, and you
and others may not agree with the manner we allocate our resources;
our drug candidates may not advance in development or be approved
for marketing; risks related to developing and commercializing
drugs; cash and revenues generated from BELVIQ and our revised
agreements with Eisai; 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; 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;
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; Arena's and third parties'
intellectual property rights; results of clinical trials and other
studies are subject to different interpretations and may not be
predictive of future results; clinical trials and other studies may
not proceed at the time or in the manner expected or at all; and
satisfactory resolution of litigation or other disagreements with
others. 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. 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
Chief Financial Officer
858.210.3636
klind@arenapharm.com
(Tables Follow)
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations
|
|
(In thousands, except
per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
|
March 31,
|
|
|
2017
|
|
2016
|
|
Revenues
|
|
|
|
|
Net product
sales
|
$
2,711
|
|
$
3,518
|
|
Other Eisai
collaboration revenue
|
1,535
|
|
3,226
|
|
Other collaboration
revenue
|
1,660
|
|
2,080
|
|
Toll
manufacturing
|
718
|
|
1,023
|
|
Total
revenues
|
6,624
|
|
9,847
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
Cost of product
sales
|
2,532
|
|
2,428
|
|
Cost of toll
manufacturing
|
919
|
|
1,188
|
|
Research &
development
|
15,511
|
|
18,502
|
|
General &
administrative
|
8,164
|
|
6,924
|
|
Total
operating costs & expenses
|
27,126
|
|
29,042
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
Interest
income
|
34
|
|
88
|
|
Interest
expense
|
(1,570)
|
|
(1,679)
|
|
Other
|
(459)
|
|
(762)
|
|
Total interest
& other income (expense), net
|
(1,995)
|
|
(2,353)
|
|
Net income
(loss)
|
(22,497)
|
|
(21,548)
|
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
444
|
|
0
|
|
Net income (loss)
attributable to stockholders of Arena
|
$
(22,053)
|
|
$
(21,548)
|
|
|
|
|
|
|
Net income(loss)
attributable to stockholders of Arena per share:
|
|
|
|
|
|
|
Basic
|
$
(0.09)
|
|
$
(0.09)
|
|
Diluted
|
$
(0.09)
|
|
$
(0.09)
|
|
|
|
|
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share:
|
|
|
|
|
Basic
|
244,822
|
|
242,876
|
|
Diluted
|
244,822
|
|
242,876
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2017
|
|
December 31,
2016
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 79,529
|
|
$ 90,712
|
|
Accounts
receivable
|
1,684
|
|
20,162
|
|
Inventory
|
7,055
|
|
6,708
|
|
Prepaid
expenses & other current assets
|
4,069
|
|
2,307
|
|
Land, property
& equipment, net
|
42,512
|
|
43,828
|
|
Intangibles
& other non-current assets
|
4,911
|
|
5,293
|
|
Total
assets
|
$ 139,760
|
|
$ 169,010
|
|
|
|
|
|
|
Liabilities &
Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$
13,008
|
|
$
25,073
|
|
Total deferred
revenues
|
34,837
|
|
37,455
|
|
Total lease
financing obligations & other long-term liabilities
|
65,259
|
|
66,087
|
|
Total
equity
|
26,656
|
|
40,395
|
|
Total
liabilities & equity
|
$ 139,760
|
|
$ 169,010
|
|
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SOURCE Arena Pharmaceuticals, Inc.