SAN DIEGO, Aug. 5, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported financial
results for the second quarter ended June
30, 2015, and provided a corporate update.
"We have continued to advance our deep clinical-stage pipeline,
as evidenced by the recent initiation of a Phase 2 proof-of-concept
clinical trial of APD334, our internally discovered S1P1
receptor modulator, in ulcerative colitis," stated Jack Lief,
Arena's President and Chief Executive Officer. "We are also
supporting our collaborators' efforts to increase patient access
and use of BELVIQ, including by working to obtain regulatory
approval of BELVIQ in additional territories and by filing later
this year an NDA for BELVIQ XR, our once-daily formulation."
Second Quarter and Recent Developments
Arena Research & Development
- Announced the initiation of patient screening in a Phase 2
proof-of-concept clinical trial of APD334, an oral Sphingosine
1-Phosphate Subtype 1 (S1P1) receptor modulator for
autoimmune diseases, being studied in this trial for the treatment
of ulcerative colitis.
- Arena and Roivant Sciences Ltd. entered into a Development,
Marketing and Supply Agreement for nelotanserin, Arena's internally
discovered inverse agonist of the serotonin 2A receptor.
- Announced results from a Phase 1 single-ascending dose clinical
trial of APD371, a highly selective and potent cannabinoid 2 (CB2)
receptor agonist in development as a potential treatment for
pain.
BELVIQ® (lorcaserin HCl) Update
- IMS Health estimates that approximately 183,000 prescriptions
for BELVIQ were filled in the United
States in the second quarter of 2015, representing growth in
total prescriptions of approximately 66% compared to the same
quarter of last year and 8.6% compared to the previous
quarter.
- Ildong Pharmaceutical Co., Ltd., estimates that approximately
1.8 million tablets of BELVIQ were prescribed in South Korea in the second quarter of 2015,
which equates to approximately 29,000 one-month prescriptions.
- BELVIQ was nominated by the Galien Foundation and Awards
Committee for the 2015 Prix Galien USA Award in the Best Pharmaceutical Agent
category.
- Arena and Eisai presented posters on lorcaserin HCl research
findings at the American Diabetes Association's 75th
Scientific Sessions, American Thoracic Society International
Conference and at the International Society for Pharmacoeconomics
and Outcomes Research.
Second Quarter 2015 Financial Results
- Revenues totaled $9.2 million,
including $4.3 million in net product
sales of BELVIQ.
- Research and development expenses totaled $24.2 million.
- General and administrative expenses totaled $8.8 million.
- Net loss was $26.8 million, or
$0.11 per share.
- At June 30, 2015, cash and cash
equivalents totaled $216.7 million
and approximately 242 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 second quarter 2015 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'
Second Quarter 2015 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 believed to decrease food consumption and promote
satiety by selectively activating serotonin 2C receptors in the
brain. The exact mechanism of action is not known.
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.
Arena has granted exclusive marketing and distribution rights
for BELVIQ to Eisai Inc. and Eisai Co., Ltd., for most territories
worldwide; to Ildong Pharmaceutical Co., Ltd., for South Korea; to CY Biotech Company Limited for
Taiwan; and to Teva Pharmaceutical
Industries Ltd.'s local Israeli subsidiary, Abic Marketing Limited,
for Israel. BELVIQ is approved for
weight management by the US Food and Drug Administration and the
Ministry of Food and Drug Safety in South
Korea. Eisai Inc. and Ildong Pharmaceutical Co., Ltd.,
market and distribute BELVIQ in the
United States and South
Korea, respectively, and Arena manufactures and supplies the
finished commercial product from its facility in Switzerland.
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's US operations are
located in San Diego, California,
and its operations outside of the United
States, including its commercial manufacturing facility, are
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® and BELVIQ XR® are registered
trademarks 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 advancing
Arena's pipeline; supporting collaborators' efforts; the
therapeutic indication, safety, efficacy, mechanism of action,
patient access and use, regulatory application and approval, and
potential of BELVIQ; the progress, therapeutic indication,
mechanism of action, regulatory application and approval,
potential, and other aspects of research and development programs;
rights, obligations, activities and expectations with respect to
collaborative agreements; embracing the challenge of improving
health; 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: risks related to commercializing drugs,
including regulatory, manufacturing, supply and marketing issues
and the availability and use of BELVIQ or lorcaserin; 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 regulatory review is
uncertain, and lorcaserin may not be approved for marketing in
combination with another drug, for another indication or using a
different formulation or in any other territory for any indication;
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 (or Arena or a
collaborator may not 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; having adequate
funds; 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: 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
|
Media Contact: Russo
Partners
David Schull,
President
david.schull@russopartnersllc.com
858.717.2310
|
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Six months
ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
Net product
sales
|
$ 4,285
|
|
$ 3,529
|
|
$ 10,903
|
|
$ 6,411
|
|
Other Eisai
collaborative revenue
|
3,213
|
|
8,554
|
|
5,349
|
|
11,901
|
|
Toll
manufacturing
|
1,390
|
|
578
|
|
1,736
|
|
1,026
|
|
Other collaborative
revenue
|
293
|
|
140
|
|
3,449
|
|
277
|
|
Total
revenues
|
9,181
|
|
12,801
|
|
21,437
|
|
19,615
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
1,303
|
|
1,463
|
|
4,494
|
|
2,294
|
|
Cost of toll
manufacturing
|
1,812
|
|
547
|
|
2,214
|
|
1,043
|
|
Research &
development
|
24,201
|
|
27,025
|
|
46,169
|
|
48,013
|
|
General &
administrative
|
8,844
|
|
9,132
|
|
17,283
|
|
17,169
|
|
Total
operating costs & expenses
|
36,160
|
|
38,167
|
|
70,160
|
|
68,519
|
|
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
|
Interest
income
|
34
|
|
24
|
|
68
|
|
53
|
|
Interest
expense
|
(1,754)
|
|
(1,735)
|
|
(3,450)
|
|
(3,482)
|
|
Gain (loss) from
valuation of derivative liabilities
|
1,171
|
|
1,006
|
|
(378)
|
|
896
|
|
Gain on sale of
available-for-sale securities
|
0
|
|
33,277
|
|
0
|
|
33,277
|
|
Other
|
721
|
|
274
|
|
1,381
|
|
385
|
|
Total interest
& other income (expense), net
|
172
|
|
32,846
|
|
(2,379)
|
|
31,129
|
|
Net income
(loss)
|
$ (26,807)
|
|
$ 7,480
|
|
$ (51,102)
|
|
$ (17,775)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
|
Basic
|
$ (0.11)
|
|
$ 0.03
|
|
$ (0.21)
|
|
$ (0.08)
|
|
Diluted
|
$ (0.11)
|
|
$ 0.03
|
|
$ (0.21)
|
|
$ (0.08)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share:
|
|
|
|
|
|
|
|
|
Basic
|
242,067
|
|
219,682
|
|
238,903
|
|
219,453
|
|
Diluted
|
242,067
|
|
225,341
|
|
238,903
|
|
219,453
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheet Data
(In
thousands)
|
|
|
|
|
|
|
June 30,
2015
|
|
December 31,
20141
|
|
|
(unaudited)
|
|
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 216,701
|
|
$ 163,209
|
|
Accounts
receivable
|
4,194
|
|
3,712
|
|
Inventory
|
11,001
|
|
10,831
|
|
Prepaid
expenses & other current assets
|
4,074
|
|
4,144
|
|
Land, property
& equipment, net
|
81,412
|
|
82,919
|
|
Intangibles
& other non-current assets
|
11,741
|
|
11,570
|
|
Total
assets
|
$ 329,123
|
|
$ 276,385
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 31,372
|
|
$ 49,158
|
|
Total deferred
revenues
|
119,565
|
|
108,302
|
|
Derivative
liabilities
|
852
|
|
474
|
|
Total lease
financing obligations & other long-term liabilities
|
69,976
|
|
71,106
|
|
Total
stockholders' equity
|
107,358
|
|
47,345
|
|
Total
liabilities & stockholders' equity
|
$ 329,123
|
|
$ 276,385
|
|
|
|
1
|
The Condensed
Consolidated Balance Sheet Data has been derived from the audited
financial statements as of that date.
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-reports-second-quarter-2015-financial-results-and-provides-corporate-update-300124368.html
SOURCE Arena Pharmaceuticals, Inc.