SAN DIEGO, May 9, 2016 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported financial
results for the first quarter ended March
31, 2016, and provided a corporate update.
"We have continued to focus on the strategic priorities that we
outlined last October, including advancing APD371 through Phase 1b
and entering into a strategic collaboration with Boehringer
Ingelheim that leverages our internally discovered compounds and
validates the strength of our R&D platform," said Harry F. Hixson, Jr., Ph.D., Arena's interim
Chief Executive Officer. "We are thrilled that Amit Munshi will join us in the next couple of
days as our President and Chief Executive Officer, and we look
forward to building stockholder value and positively impacting
patient lives under Mr. Munshi's leadership."
First Quarter and Recent Developments
Corporate Update
- Appointed Amit D. Munshi as
President, Chief Executive Officer and interim principal financial
officer, effective May 11, 2016. Mr.
Munshi will also join Arena's Board of Directors following Arena's
2016 annual stockholders' meeting, which is scheduled for
June 13, 2016.
Research and Development Update
- Announced favorable results from a Phase 1b multiple-ascending
dose clinical trial of APD371, a highly selective and potent
agonist of the cannabinoid 2 (CB2) receptor with potential utility
in the treatment of pain.
- Arena and Boehringer Ingelheim International GmbH entered into
a collaboration that grants Boehringer Ingelheim exclusive
worldwide rights to Arena's internally discovered, novel compounds
and intellectual property related to an orphan central nervous
system (CNS) receptor. The collaboration also enables joint
research in the field of schizophrenia aimed at identifying
additional drug candidates.
BELVIQ® (lorcaserin HCl) Update
- IMS Health estimates that approximately 121,000 prescriptions
for BELVIQ were filled in the United
States in the first quarter of 2016.
- Ildong Pharmaceutical Co., Ltd., estimates that approximately
2.1 million tablets of BELVIQ were prescribed in South Korea in the first quarter of 2016,
which equates to approximately 34,700 one-month prescriptions.
First Quarter 2016 Financial Results
- Revenues totaled $9.8 million,
including $3.5 million in net product
sales of BELVIQ
- Research and development expenses totaled $18.5 million
- General and administrative expenses totaled $6.9 million
- Net loss was $21.5 million, or
$0.09 per share
- At March 31, 2016, cash and cash
equivalents totaled $139.5 million
and approximately 243.0 million shares of common stock were
outstanding
Scheduled Conference Call and Webcast
Arena will host a conference call and webcast today at
5:00 p.m. Eastern Time
(2:00 p.m. Pacific Time) to provide a corporate update and
report first quarter 2016 financial results. The conference call
may be accessed by dialing 877.643.7155 for domestic callers and
914.495.8552 for international callers. Please specify to the
operator that you would like to join the "Arena Pharmaceuticals'
First Quarter 2016 Financial Results and Corporate Update
Conference Call." The conference call will be webcast live under
the investor relations section of Arena's website at
www.arenapharm.com, and will be archived there for 30 days
following the call. Please connect to Arena's website several
minutes prior to the start of the broadcast to ensure adequate time
for any software download that may be necessary.
About BELVIQ® (lorcaserin HCl) CIV
BELVIQ is approved by the US Food and Drug Administration to be
used along with a reduced-calorie diet and increased physical
activity for chronic weight management in adult patients with an
initial body mass index of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of
at least one weight-related comorbid condition (e.g., hypertension,
dyslipidemia, type 2 diabetes).
Limitations of Use:
- The safety and efficacy of coadministration of BELVIQ with
other products intended for weight loss including prescription
drugs (e.g., phentermine), over-the-counter drugs, and herbal
preparations have not been established.
- The effect of BELVIQ on cardiovascular morbidity and mortality
has not been established.
In clinical trials, the most common adverse reactions for
patients without diabetes treated with BELVIQ were headache,
dizziness, fatigue, nausea, dry mouth, and constipation, and, in
patients with diabetes, the most common adverse reactions were
hypoglycemia, headache, back pain, cough, and fatigue.
For additional information about BELVIQ, including important
safety information, click here for the full Prescribing Information
or visit www.BELVIQ.com.
About Arena Pharmaceuticals
Arena embraces the challenge of improving health by seeking to
bring innovative medicines targeting G protein-coupled receptors to
patients. Arena's focus is discovering, developing and
commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first internally
discovered drug approved for marketing. Arena has US operations
located in San Diego, California, and operations outside of the
United States, including its
commercial manufacturing facility, located in Zofingen,
Switzerland. For more information,
visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
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 timing and
significance of Mr. Munshi's appointment as an executive officer
and director; building stockholder value and impacting lives;
rights, activities and expectations with respect to the
collaboration with Boehringer Ingelheim; the therapeutic
indication, use, safety, efficacy, mechanism of action and
potential of BELVIQ and APD371; embracing the challenge of
improving health and seeking to bring innovative medicines to
patients; and Arena's focus, plans, goals, strategy, expectations,
research and development programs, and ability to discover and
develop compounds and commercialize drugs. 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: having adequate funds and
other resources and their effective use; enrollment in the ongoing
Phase 2 clinical trials of APD334 and ralinepag is competitive and
challenging, and their progress, completion and results are
uncertain; recruiting and retaining effective management and other
key employees; risks related to commercializing drugs, including
regulatory, product supply, marketing and use; the focus, efforts
and decisions of collaborators; the entry into, modification or
termination of collaborative arrangements, and risks related to
relying on such arrangements; the timing and receipt of payments
from others; 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 regulatory review is
uncertain, and lorcaserin may not receive any additional marketing
approvals; regulatory decisions in one territory may impact other
regulatory decisions and Arena's business prospects; reimbursement
and pricing decisions; the timing, success and cost of Arena's
research and development; 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;
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 (or Arena or
a collaborator may not pursue) further research and development,
regulatory review or approval or continued marketing; intellectual
property rights; and satisfactory resolution of litigation or other
disagreements. 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: Arena
Pharmaceuticals, Inc.
Craig M. Audet, Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
www.arenapharm.com
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations
|
(In thousands, except
per share amounts)
|
|
Three months
ended
March 31,
|
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
Net product
sales
|
$ 3,518
|
|
$ 6,618
|
|
Other Eisai
collaborative revenue
|
3,226
|
|
2,136
|
|
Toll
manufacturing
|
1,023
|
|
346
|
|
Other collaborative
revenue
|
2,080
|
|
3,156
|
|
Total
revenues
|
9,847
|
|
12,256
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
Cost of product
sales
|
2,428
|
|
3,191
|
|
Cost of toll
manufacturing
|
1,188
|
|
402
|
|
Research &
development
|
18,502
|
|
21,968
|
|
General &
administrative
|
6,924
|
|
8,439
|
|
Total
operating costs & expenses
|
29,042
|
|
34,000
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
Interest
income
|
88
|
|
34
|
|
Interest
expense
|
(1,679)
|
|
(1,696)
|
|
Loss from valuation
of derivative liabilities
|
0
|
|
(1,549)
|
|
Other
|
(762)
|
|
660
|
|
Total interest
& other expense, net
|
(2,353)
|
|
(2,551)
|
|
Net loss
|
$(21,548)
|
|
$(24,295)
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
Basic
|
$ (0.09)
|
|
$ (0.10)
|
|
Diluted
|
$ (0.09)
|
|
$ (0.10)
|
|
|
|
|
|
|
Shares used in
calculating net loss per share:
|
|
|
|
|
Basic
|
242,876
|
|
235,703
|
|
Diluted
|
242,876
|
|
235,703
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2016
|
|
December 31,
2015
|
|
|
(unaudited)
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 139,533
|
|
$ 156,184
|
|
Accounts
receivable
|
6,166
|
|
4,934
|
|
Inventory
|
9,054
|
|
9,502
|
|
Prepaid
expenses & other current assets
|
5,362
|
|
4,218
|
|
Land, property
& equipment, net
|
71,003
|
|
71,828
|
|
Intangibles
& other non-current assets
|
10,246
|
|
10,126
|
|
Total
assets
|
$ 241,364
|
|
$ 256,792
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 25,122
|
|
$ 25,493
|
|
Total deferred
revenues
|
110,632
|
|
109,042
|
|
Total lease
financing obligations & other long-term liabilities
|
68,052
|
|
68,715
|
|
Total
stockholders' equity
|
37,558
|
|
53,542
|
|
Total
liabilities & stockholders' equity
|
$ 241,364
|
|
$ 256,792
|
|
|
|
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.