SAN DIEGO, Feb. 29, 2016 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported financial
results for the fourth quarter and full year ended
December 31, 2015, and provided a corporate update.
"Arena took a number of important steps in 2015, including
initiating two Phase 2 clinical trials, partnering two of our
programs, filing a new drug application and reducing our internal
expenses," said Harry F. Hixson,
Jr., Arena's interim Chief Executive Officer. "We entered
2016 focused on advancing our internal and partnered clinical-stage
compounds that we believe will highlight the intrinsic value of our
pipeline and the strength of our R&D capabilities."
Fourth Quarter and Recent Developments
Research & Development
- Announced the initiation of a Phase 1b multiple-ascending dose
clinical trial of APD371, a selective and potent agonist of the
cannabinoid 2 receptor.
- Announced a collaboration with Boehringer Ingelheim
International GmbH that grants them exclusive worldwide rights to
Arena's internally discovered, novel compounds and intellectual
property related to an orphan central nervous system, or CNS,
receptor. The collaboration also enables joint research in the
field of schizophrenia aimed at identifying additional drug
candidates.
- Announced that the CAMELLIA-TIMI 61 study reached its target
enrollment of 12,000 patients. The CAMELLIA-TIMI 61 study is
designed to evaluate the impact of long-term treatment with BELVIQ
on the incidence of major adverse cardiovascular events and
conversion to type 2 diabetes mellitus in obese and overweight
patients with cardiovascular disease and/or multiple cardiovascular
risk factors.
- Announced that the US Food and Drug Administration accepted for
filing the New Drug Application for a once-daily formulation of
lorcaserin, which is planned to be marketed as BELVIQ
XR®.
- Axovant Sciences Ltd. announced the initiation of a Phase 2
clinical trial of nelotanserin, Arena's internally discovered
inverse agonist of the serotonin 2A receptor, in patients with
dementia with Lewy Bodies or Parkinson's disease dementia suffering
from visual hallucinations. Axovant also announced plans to
initiate a second Phase 2 clinical trial this quarter in patients
with dementia with Lewy Bodies suffering from REM behavior
disorder.
BELVIQ® (lorcaserin HCl) Commercial
Update
- IMS Health estimates that approximately 131,000 prescriptions
for BELVIQ were filled in the US in the fourth quarter of
2015.
- Ildong Pharmaceutical Co., Ltd., estimates that approximately
2.4 million tablets of BELVIQ were prescribed in South Korea in the fourth quarter of 2015,
which equates to approximately 40,000 one-month prescriptions.
- 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.
Corporate Update
- Hosted an Analyst and Investor Day in New York that included presentations by
company management and key opinion leaders detailing Arena's
internally discovered research and development programs.
Fourth Quarter 2015 Financial Results
- Revenues totaled $7.8 million,
including $3.9 million in net product
sales of BELVIQ.
- Research and development expenses totaled $20.2 million.
- General and administrative expenses totaled $9.7 million.
- Restructuring charges totaled $4.0
million.
- Net loss was $30.5 million, or
$0.13 per share.
- At December 31, 2015, cash and
cash equivalents totaled $156.2
million which does not include the $7.5 million upfront payment from the Boehringer
Ingelheim agreement.
- At December 31, 2015,
approximately 242.9 million shares of common stock were
outstanding.
Full Year 2015 Financial Results
- Revenues totaled $38.3 million,
including $19.7 million in net
product sales of BELVIQ.
- Research and development expenses totaled $88.4 million.
- General and administrative expenses totaled $36.0 million.
- Restructuring charges totaled $4.0
million.
- Net loss was $108.0 million, or
$0.45 per share.
2016 Financial Guidance
Absent any new collaborations, Arena expects its 2016 revenues
will primarily consist of (i) net product sales of BELVIQ, (ii)
milestone achievements under existing collaborations, (iii)
amortization of upfront payments from existing collaborations, (iv)
toll manufacturing and (v) research funding and patent
reimbursements from existing collaborations. Arena does not believe
it can accurately predict the amount of future net product sales of
BELVIQ or the timing of milestone achievements, if any, and,
accordingly, is not providing guidance for its overall 2016
revenues at this time. The amount of BELVIQ net product sales is
expected to depend on Eisai's marketing efforts, including relating
to BELVIQ XR if approved later this year, the extent of
reimbursement coverage for BELVIQ in the
United States, and receiving regulatory approval in
countries outside the United States. Potential milestones
payments for 2016 of up to an aggregate of approximately
$16.0 million include milestones for
obtaining regulatory approval for the once-daily formulation of
lorcaserin, BELVIQ XR, in the United
States, regulatory approval of the twice-daily formulation
of lorcaserin, BELVIQ, in Mexico,
Brazil and Israel, and acceptance by Boehringer Ingelheim
of a first development compound. Amortization of upfront
payments from existing collaborations is expected to be
approximately $12.0 million, toll
manufacturing revenue is expected to be approximately $4.0 million, and research funding and patent
reimbursements from existing collaborations are expected to be
approximately $3.0 million.
Arena expects full year 2016 research and development expenses
of approximately $89.0 million to $98.0
million, including non-cash expenses of approximately
$11.0 million. The research and
development expenses include external clinical and preclinical
study fees of approximately $45.0 million to
$49.0 million, most of which relates to Arena's continuing
Phase 2 clinical trials for APD334 and APD811 and its share of the
costs for the BELVIQ cardiovascular outcomes trial. Arena also
expects full year 2016 general and administrative expenses of
approximately $27.0 million to $33.0
million, including non-cash expenses of approximately
$7.0 million. In addition, Arena
expects to spend approximately $1.0 million
to $2.0 million for capital expenditures and approximately
$9.0 million for payments related to
its financing obligations for the sale and lease back of certain of
its real property. Arena may adjust its expenses based on the cash
it receives during the year, including from BELVIQ net product
sales or any milestones or new collaborations.
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 fourth quarter and full year 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' Fourth Quarter and Full Year 2015 Financial
Results 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'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 the importance
of steps taken in 2015; advancing clinical-stage compounds;
highlighting the value of Arena's pipeline and strength of its
R&D capabilities; rights, activities and expectations with
respect to collaborations, including with respect to research and
development and regulatory activities; the progress, study,
therapeutic indication, mechanism of action and potential of
compounds and other aspects of research and development; the
therapeutic indication, use, safety, efficacy, mechanism of action
and potential of BELVIQ, BELVIQ XR or lorcaserin; financial
guidance and related assumptions and expectations; 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: having
adequate funds and other assets and their effective use; risks
related to commercializing BELVIQ or any future drug, including
regulatory, manufacturing, supply and marketing issues and their
availability and use; 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; 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; 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;
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; 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
|
|
Year ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(Note)
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product
sales
|
$
|
3,939
|
|
|
$
|
3,846
|
|
|
$
|
19,726
|
|
|
$
|
15,983
|
|
|
Other Eisai
collaborative revenue
|
2,091
|
|
|
4,577
|
|
|
9,505
|
|
|
18,611
|
|
|
Toll
manufacturing
|
1,051
|
|
|
313
|
|
|
4,250
|
|
|
1,497
|
|
|
Other collaborative
revenue
|
670
|
|
|
455
|
|
|
4,845
|
|
|
879
|
|
|
Total
revenues
|
7,751
|
|
|
9,191
|
|
|
38,326
|
|
|
36,970
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
2,461
|
|
|
2,320
|
|
|
8,590
|
|
|
6,369
|
|
|
Cost of toll
manufacturing
|
787
|
|
|
266
|
|
|
4,585
|
|
|
1,390
|
|
|
Research &
development
|
20,170
|
|
|
27,826
|
|
|
88,411
|
|
|
100,347
|
|
|
General &
administrative
|
9,655
|
|
|
8,939
|
|
|
35,966
|
|
|
34,137
|
|
|
Restructuring
|
3,972
|
|
|
0
|
|
|
3,972
|
|
|
0
|
|
|
Total operating costs
& expenses
|
37,045
|
|
|
39,351
|
|
|
141,524
|
|
|
142,243
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
53
|
|
|
14
|
|
|
158
|
|
|
83
|
|
|
Interest
expense
|
(1,695)
|
|
|
(1,710)
|
|
|
(6,828)
|
|
|
(6,915)
|
|
|
Gain from valuation
of derivative liabilities
|
0
|
|
|
929
|
|
|
474
|
|
|
4,418
|
|
|
Gain on sale of
available-for-sale securities
|
0
|
|
|
0
|
|
|
0
|
|
|
49,553
|
|
|
Other
|
477
|
|
|
(1,134)
|
|
|
1,415
|
|
|
(2,374)
|
|
|
Total interest &
other income (expense), net
|
(1,165)
|
|
|
(1,901)
|
|
|
(4,781)
|
|
|
44,765
|
|
|
Net loss
|
$
|
(30,459)
|
|
|
$
|
(32,061)
|
|
|
$
|
(107,979)
|
|
|
$
|
(60,508)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.13)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.28)
|
|
|
Diluted
|
$
|
(0.13)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.28)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
242,566
|
|
|
220,152
|
|
|
240,671
|
|
|
219,734
|
|
|
Diluted
|
242,566
|
|
|
220,152
|
|
|
240,671
|
|
|
219,734
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: The Condensed
Consolidated Statements of Operations have been derived from the
audited financial statements for the years ended December 31, 2015
and 2014, respectively.
|
Arena
Pharmaceuticals, Inc. Condensed Consolidated Balance Sheet
Data (In
thousands)
|
|
|
|
|
|
|
December 31,
2015
|
|
December 31,
2014
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash & cash
equivalents
|
$
|
156,184
|
|
|
$
|
163,209
|
|
|
Accounts
receivable
|
4,934
|
|
|
3,712
|
|
|
Inventory
|
9,502
|
|
|
10,831
|
|
|
Prepaid expenses
& other current assets
|
4,218
|
|
|
4,144
|
|
|
Land, property &
equipment, net
|
71,828
|
|
|
82,919
|
|
|
Intangibles &
other non-current assets
|
10,126
|
|
|
11,570
|
|
|
Total
assets
|
$
|
256,792
|
|
|
$
|
276,385
|
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts payable
& accrued liabilities
|
$
|
25,493
|
|
|
$
|
49,158
|
|
|
Total deferred
revenues
|
109,042
|
|
|
108,302
|
|
|
Derivative
liabilities
|
0
|
|
|
474
|
|
|
Total lease financing
obligations & other long-term liabilities
|
68,715
|
|
|
71,106
|
|
|
Total stockholders'
equity
|
53,542
|
|
|
47,345
|
|
|
Total liabilities
& stockholders' equity
|
$
|
256,792
|
|
|
$
|
276,385
|
|
|
|
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-fourth-quarter-and-full-year-2015-financial-results-and-provides-corporate-update-300227826.html
SOURCE Arena Pharmaceuticals, Inc.