SAN DIEGO, Nov. 7, 2016 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA), today reported financial
results for the third quarter ended September 30, 2016, and provided a corporate
update.
"This was a highly productive quarter for Arena. We
continue to make significant progress focusing the company on our
unpartnered clinical programs and building a high performing
product development organization. We have expanded our clinical
development and management team to facilitate better execution in a
time and cost effective manner," said Amit
Munshi, Arena's President and CEO. "We are
enthusiastic about our strategy to focus on our clinical stage
programs, with a goal of developing first- or best-in-class assets
with our three proprietary compounds which includes evaluating ways
to expand their indications. In support of our programs, we have
initiated efforts to communicate to the scientific community
through an active outreach and publication strategy."
Publications Update
- Etrasimod (APD334)
- Presented data on etrasimod's S1P receptor profile at the
United European Gastroenterology Week (UEGW) Meeting on
October 18, 2016.
- Received acceptance of four poster presentations at the
upcoming Advances in Inflammatory Bowel Diseases 2016 (AIBD)
conference, which will be held on December
8-10, 2016.
- Preclinical Safety Assessment of Etrasimod (APD334), an Oral
Sphingosine-1-Phosphate Receptor (S1P) Modulator with a Unique
Profile
- The Sphingosine-1-Phosphate Receptor (S1P) Modulator Etrasimod
(APD334) Demonstrates Limited Effects on Heart Rate in Preclinical
Testing
- Safety, Pharmacokinetics and Pharmacodynamics of Etrasimod
(APD334), an Oral Selective S1P Receptor Modulator, after
Dose-Escalation, in Healthy Volunteers
- Etrasimod (APD334), a Potent, Selective, Oral S1P Receptor
Modulator with Autoimmune Disease-Modifying Activity Exhibiting
Favorable PK/PD Properties in Healthy Volunteers
Collaborations Update
- Eisai, Ltd. and Eisai Inc.
- On October 3, 2016, Eisai
announced the availability of once daily BELVIQ XR® in the US.
Corporate Update
- Vincent Aurentz was appointed as
Executive Vice President and Chief Business Officer, effective
August 15, 2016.
- Beacon Discovery, a privately held drug discovery incubator,
was formed as a means to unlock the value of Arena's historical
research platform. Beacon focuses on identifying and advancing
molecules targeting G-Protein Coupled Receptors, or
GCPRs.
Third Quarter 2016 Financial Results
- Revenues totaled $19.2 million,
including $3.3 million in net product
sales of BELVIQ and $11.0 million in
milestone payments earned from Eisai for BELVIQ
- Research and development expenses totaled $17.5 million
- General and administrative expenses totaled $8.6 million
- Restructuring charges totaled $0.2
million
- Net loss attributable to stockholders of Arena was $12.4 million or $0.05 per share
- At September 30, 2016, cash and
cash equivalents totaled $101.6
million and approximately 243 million shares of Arena common
stock were outstanding
Conference Call & Webcast Information
The Company
will host a conference call and live webcast with the investment
community today, Monday, November 7,
2016 at 4:30 p.m. ET to
discuss the financial results and provide a corporate update.
When: November 7, 2016,
4:30 p.m. ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: Arena Pharmaceuticals Third Quarter 2016 Conference
Call
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
We are a biopharmaceutical
company focused on developing novel, small molecule drugs across a
range of therapeutic areas. We have three primary proprietary
investigational clinical programs: etrasimod (APD334) in Phase 2
evaluation for ulcerative colitis, APD371 entering Phase 2
evaluation for the treatment of pain associated with Crohn's
disease, and ralinepag (APD811) in Phase 2 evaluation for pulmonary
arterial hypertension (PAH). Additionally, we have
collaborations with the following pharmaceutical companies: Eisai
Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences Ltd.
(Phase 2 candidate), and Boehringer Ingelheim International GmbH
(preclinical candidate).
Our US operations are located in San
Diego, California. Our primary clinical operations are
located in Zug, Switzerland, and
our commercial manufacturing for BELVIQ is located in Zofingen,
Switzerland.
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 focus and goals of Arena's organization;
Arena's plans and strategy; and Arena's 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 risk that we may need additional funds to advance all of
our programs, and you and others may not agree with the manner we
allocate our resources; risks related to developing and
commercializing drugs; cash and revenues generated from BELVIQ,
including the impact of competition; 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; the timing and outcome of development
and regulatory review is uncertain, and our drug candidates may not
be approved for marketing; regulatory decisions in one territory
may impact other regulatory decisions and Arena's business
prospects; government and commercial reimbursement and pricing
decisions; risks related to relying on collaborative arrangements;
the timing and receipt of payments and fees, if any, from
collaborators; 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;
data and other information related to any of Arena's research and
development may not meet regulatory requirements or otherwise be
sufficient for Arena or a collaborator to pursue further research
and development, regulatory review or approval or continued
marketing; Arena's and third parties' intellectual property rights;
the timing, success and cost of Arena's research and development
and related strategy and decisions; 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.
Contact:
Kevin R. Lind,
Chief Financial Officer
klind@arenapharm.com
858.210.3636
(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,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
Net product
sales
|
$
3,323
|
|
$
4,884
|
|
$
11,104
|
|
$
15,787
|
|
Other Eisai
collaboration revenue
|
12,954
|
|
2,065
|
|
18,155
|
|
7,414
|
|
Toll
manufacturing
|
1,228
|
|
1,463
|
|
3,276
|
|
3,199
|
|
Other collaboration
revenue
|
1,737
|
|
726
|
|
6,066
|
|
4,175
|
|
Total
revenues
|
19,242
|
|
9,138
|
|
38,601
|
|
30,575
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
882
|
|
1,635
|
|
4,161
|
|
6,129
|
|
Cost of toll
manufacturing
|
1,930
|
|
1,584
|
|
4,876
|
|
3,798
|
|
Research &
development
|
17,466
|
|
22,072
|
|
54,514
|
|
68,241
|
|
General &
administrative
|
8,590
|
|
9,028
|
|
23,979
|
|
26,311
|
|
Restructuring
charges
|
231
|
|
0
|
|
6,346
|
|
0
|
|
Total
operating costs & expenses
|
29,099
|
|
34,319
|
|
93,876
|
|
104,479
|
|
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
|
Interest
income
|
54
|
|
37
|
|
247
|
|
105
|
|
Interest
expense
|
(1,609)
|
|
(1,683)
|
|
(4,907)
|
|
(5,133)
|
|
Gain from valuation
of derivative liabilities
|
0
|
|
852
|
|
0
|
|
474
|
|
Other
|
(1,067)
|
|
(443)
|
|
(1,275)
|
|
938
|
|
Total interest
& other expense, net
|
(2,622)
|
|
(1,237)
|
|
(5,935)
|
|
(3,616)
|
|
Net loss
|
(12,479)
|
|
(26,418)
|
|
(61,210)
|
|
(77,520)
|
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
122
|
|
0
|
|
122
|
|
0
|
|
Net loss attributable
to stockholders of Arena
|
$
(12,357)
|
|
$
(26,418)
|
|
$
(61,088)
|
|
$
(77,520)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to stockholders of Arena per share:
|
|
|
|
|
|
|
|
|
Basic
|
$
(0.05)
|
|
$
(0.11)
|
|
$
(0.25)
|
|
$
(0.32)
|
|
Diluted
|
$
(0.05)
|
|
$
(0.11)
|
|
$
(0.25)
|
|
$
(0.32)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share:
|
|
|
|
|
|
|
|
|
Basic
|
243,254
|
|
242,257
|
|
243,069
|
|
240,033
|
|
Diluted
|
243,254
|
|
242,257
|
|
243,069
|
|
240,033
|
|
|
|
|
|
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2016
|
|
December 31,
2015
|
|
|
(unaudited)
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 101,629
|
|
$ 156,184
|
|
Accounts
receivable
|
18,304
|
|
4,934
|
|
Inventory
|
10,166
|
|
9,502
|
|
Prepaid
expenses & other current assets
|
4,768
|
|
4,218
|
|
Land, property
& equipment, net
|
64,980
|
|
71,828
|
|
Intangibles
& other non-current assets
|
10,401
|
|
10,126
|
|
Total
assets
|
$ 210,248
|
|
$ 256,792
|
|
|
|
|
|
|
Liabilities &
Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$
34,608
|
|
$
25,493
|
|
Total deferred
revenues
|
104,654
|
|
109,042
|
|
Total lease
financing obligations & other long-term liabilities
|
66,909
|
|
68,715
|
|
Total
equity
|
4,077
|
|
53,542
|
|
Total
liabilities & equity
|
$ 210,248
|
|
$ 256,792
|
|
|
1
The Condensed Consolidated Balance Sheet Data has been derived from
the audited financial statements as of that date.
|
Logo - http://photos.prnewswire.com/prnh/20161107/436843LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-reports-third-quarter-2016-financial-results-and-provides-corporate-update-300358633.html
SOURCE Arena Pharmaceuticals, Inc.