SAN DIEGO, Nov. 10, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported financial
results for the third quarter ended September 30, 2015, and provided a corporate
update.
"On October 27, we announced a
plan to improve efficiencies and reduce costs as we chart a new
course for Arena with our refocusing effort," said Harry F. Hixson, Jr., Arena's interim Chief
Executive Officer. "As we head into 2016, we intend to continue to
implement this plan to be sure we are taking full advantage of our
key strengths in a strategic, optimized manner."
Third Quarter and Recent Developments
Corporate Update
- Announced plans to improve efficiencies and reduce costs as it
focuses on the advancement of its research and development
priorities. As part of this initiative, Arena reduced its US
workforce by approximately 80 employees or 35%, which is expected
to reduce annualized cash expenditures for personnel by
approximately $11.0 million. Arena
plans to implement additional cost control measures to further
reduce its expenditures, including reductions at its Swiss
manufacturing facility, Arena Pharmaceuticals GmbH.
Research and Development Update
- Announced the initiation of a Phase 2 proof-of-concept clinical
trial of APD334, an oral Sphingosine 1-Phosphate Subtype 1 receptor
modulator for autoimmune diseases, being studied in this trial for
the treatment of ulcerative colitis.
- Announced the initiation of a Phase 1b multiple-ascending dose
clinical trial of APD371, a selective and potent agonist of the
cannabinoid 2 receptor.
- Axovant Sciences Ltd. acquired all of Roivant Sciences Ltd.'s
rights to nelotanserin, an inverse agonist of the serotonin 2A
receptor internally discovered by Arena. Arena previously granted
Roivant, Axovant's parent company, exclusive worldwide rights to
develop and commercialize nelotanserin under a Development,
Marketing and Supply Agreement. Axovant announced that it intends
to initiate two Phase 2 clinical trials with nelotanserin in the
first quarter of 2016, with the first trial in patients with either
dementia with Lewy bodies, or Parkinson's disease dementia who
suffer from visual hallucinations, and the second trial in dementia
with Lewy bodies patients experiencing REM Behavior Disorder.
BELVIQ® (lorcaserin HCl) Update
- Eisai acknowledged difficulties in the US anti-obesity market
and announced plans to focus on patients and physicians in certain
areas of the US where there is insurance coverage and a need for
treatment options.
- IMS Health estimates that approximately 157,000 prescriptions
for BELVIQ were filled in the US in the third quarter of 2015,
representing growth in total prescriptions of approximately 9.8%
compared to the same quarter of last year and a decrease of 14.4%
compared to the previous quarter.
- Ildong Pharmaceutical Co., Ltd., estimates that approximately
2.1 million tablets of BELVIQ were prescribed in South Korea in the third quarter of 2015,
which equates to approximately 34,400 one-month prescriptions,
representing growth in total prescriptions of approximately 18.6%
compared to the previous quarter.
- Announced that the US Patent and Trademark Office granted Arena
US Patent No. 9,169,213, entitled "Method of Weight Management,"
covering BELVIQ for chronic weight management. The patent is based
on the discovery that achieving 5% weight loss with BELVIQ by Week
12 is a strong predictor of responses in weight loss at Week 52 of
treatment.
Third Quarter 2015 Financial Results
- Revenues totaled $9.1 million,
including $4.9 million in net product
sales of BELVIQ.
- Research and development expenses totaled $22.1 million.
- General and administrative expenses totaled $9.0 million.
- Net loss was $26.4 million, or
$0.11 per share.
- At September 30, 2015, cash and
cash equivalents totaled $181.3
million and approximately 242.4 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 third 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'
Third 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 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 Arena's
workforce reduction, plans and refocusing effort, including with
respect to implementing the plan, improving efficiencies, reducing
costs, implementing cost control measures, taking advantage of
strengths, advancing research and development, expected outcome and
other related activities and expectations; the progress, study,
therapeutic indication, mechanism of action and potential of
compounds and other aspects of research and development; rights,
activities and expectations with respect to collaborations; the
therapeutic indication, use, safety, efficacy, mechanism of action
and potential of BELVIQ or lorcaserin; patent coverage; 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
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
September
30,
|
|
|
September
30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
Net product
sales
|
$ 4,884
|
|
$ 5,726
|
|
$ 15,787
|
|
$ 12,137
|
|
Other Eisai
collaborative revenue
|
2,065
|
|
2,133
|
|
7,414
|
|
14,034
|
|
Toll
manufacturing
|
1,463
|
|
158
|
|
3,199
|
|
1,184
|
|
Other collaborative
revenue
|
726
|
|
147
|
|
4,175
|
|
424
|
|
Total
revenues
|
9,138
|
|
8,164
|
|
30,575
|
|
27,779
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
1,635
|
|
1,755
|
|
6,129
|
|
4,049
|
|
Cost of toll
manufacturing
|
1,584
|
|
81
|
|
3,798
|
|
1,124
|
|
Research &
development
|
22,072
|
|
24,508
|
|
68,241
|
|
72,521
|
|
General &
administrative
|
9,028
|
|
8,029
|
|
26,311
|
|
25,198
|
|
Total
operating costs & expenses
|
34,319
|
|
34,373
|
|
104,479
|
|
102,892
|
|
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
|
Interest
income
|
37
|
|
16
|
|
105
|
|
69
|
|
Interest
expense
|
(1,683)
|
|
(1,723)
|
|
(5,133)
|
|
(5,205)
|
|
Gain from valuation
of derivative liabilities
|
852
|
|
2,593
|
|
474
|
|
3,489
|
|
Gain on sale of
available-for-sale securities
|
0
|
|
16,276
|
|
0
|
|
49,553
|
|
Other
|
(443)
|
|
(1,625)
|
|
938
|
|
(1,240)
|
|
Total interest
& other income (expense), net
|
(1,237)
|
|
15,537
|
|
(3,616)
|
|
46,666
|
|
Net loss
|
$ (26,418)
|
|
$ (10,672)
|
|
$ (77,520)
|
|
$ (28,447)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
Basic
|
$ (0.11)
|
|
$ (0.05)
|
|
$ (0.32)
|
|
$ (0.13)
|
|
Diluted
|
$ (0.11)
|
|
$ (0.05)
|
|
$ (0.32)
|
|
$ (0.13)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss per share:
|
|
|
|
|
|
|
|
|
Basic
|
242,257
|
|
219,866
|
|
240,033
|
|
219,592
|
|
Diluted
|
242,257
|
|
219,866
|
|
240,033
|
|
219,592
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2015
|
|
December 31,
2014
|
|
|
(unaudited)
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 181,280
|
|
$ 163,209
|
|
Accounts
receivable
|
3,514
|
|
3,712
|
|
Inventory
|
10,243
|
|
10,831
|
|
Prepaid
expenses & other current assets
|
5,179
|
|
4,144
|
|
Land, property
& equipment, net
|
74,752
|
|
82,919
|
|
Intangibles
& other non-current assets
|
11,159
|
|
11,570
|
|
Total
assets
|
$ 286,127
|
|
$ 276,385
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 21,511
|
|
$ 49,158
|
|
Total deferred
revenues
|
113,060
|
|
108,302
|
|
Derivative
liabilities
|
0
|
|
474
|
|
Total lease
financing obligations & other long-term liabilities
|
69,355
|
|
71,106
|
|
Total
stockholders' equity
|
82,201
|
|
47,345
|
|
Total
liabilities & stockholders' equity
|
$ 286,127
|
|
$ 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,
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SOURCE Arena Pharmaceuticals, Inc.