SAN DIEGO, Nov. 3, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today provided a corporate
update and reported financial results for the third quarter ended
September 30, 2014.
"The third quarter saw continued growth for
BELVIQ® with prescriptions increasing by
approximately 30% over the previous quarter," said Jack Lief,
Arena's President and Chief Executive Officer. "More recently, we
met our goal of completing and reporting on top-line results from
our trials evaluating coadministration of lorcaserin and
phentermine and lorcaserin for smoking cessation, both of which
delivered promising data. Looking forward, we are excited by the
potential advancement of our lorcaserin life cycle programs as well
as additional progress in our other research and development
programs."
Third Quarter and Recent Developments
BELVIQ® (lorcaserin HCl) CIV US Commercial
Update
- IMS Health estimates that approximately 143,000 prescriptions
for BELVIQ were filled in the third quarter of 2014, representing
growth of approximately 30% in total prescriptions as compared to
the previous quarter.
- Eisai recorded net product sales for BELVIQ of $16.8 million in the third quarter of 2014.
BELVIQ Additional Developments
- Arena and Eisai announced top-line results of a pilot study to
assess the safety of lorcaserin, when coadministered with
phentermine. The results of the investigational study demonstrate
that the short-term combination of lorcaserin plus phentermine does
not appear to be associated with an exacerbation in the proportion
of pre-specified adverse events compared to therapy with lorcaserin
alone.
- Arena and Eisai announced top-line results from the Phase 2
trial investigating lorcaserin for smoking cessation. This
proof-of-concept trial provided what is believed to be the first
clinical evidence that a selective serotonin 2C agonist may have a
treatment effect for smoking cessation.
- Arena completed dosing in two Phase 1 clinical studies
evaluating a lorcaserin 20 mg extended release tablet.
- Arena and Eisai presented multiple posters on lorcaserin
research findings at the American Society of Bariatric Physician's
64th Annual Obesity and Associated Conditions Symposium
and at the American College of Clinical Pharmacy Annual Meeting,
both held in Austin, Texas.
- Arena and Eisai announced that a pooled analysis of the BLOOM
and BLOSSOM pivotal, Phase 3 clinical trials of BELVIQ was
published in the October issue of Postgraduate Medicine. In
the pooled analysis, BELVIQ 10 mg twice daily, as compared to
placebo and both in conjunction with diet and exercise, was
associated with statistically significant weight loss and
clinically relevant improvements in cardiometabolic
parameters.
Arena Research & Development
- Initiated enrollment in a Phase 1 multiple-ascending dose trial
of APD334, Arena's S1P1 receptor agonist intended for the treatment
of autoimmune diseases.
- Ralinepag (formerly known as APD811) granted orphan drug status
by the US Food and Drug Administration for the treatment of
pulmonary arterial hypertension.
Third Quarter 2014 Financial Results
- Revenues totaled $8.2 million,
including $5.7 million in net product
sales of BELVIQ, of which $5.2
million represented 31.5% of Eisai's net product sales and
$0.5 million related to redemptions
of the 15-day free voucher.
- Research and development expenses totaled $24.5 million.
- General and administrative expenses totaled $8.0 million.
- Gain on sale of available-for-sale securities of $16.3 million related to Arena's investment in
TaiGen.
- Net loss was $10.7 million, or
$0.05 per share.
- At September 30, 2014, cash and
cash equivalents totaled $188.3
million.
- At September 30, 2014,
approximately 220.1 million shares of common stock were
outstanding.
Scheduled Conference Call and Webcast
Arena will host a conference call and webcast to provide a
corporate update and report third quarter 2014 financial results
today at 8:30 a.m. Eastern Time
(5:30 a.m. Pacific Time). 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 2014
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.
Upcoming Conference Participation
Arena is planning to participate at upcoming investment and
industry conferences, including:
- 2014 Credit Suisse Healthcare Conference, November 10-13, 2014, Phoenix, Arizona
- The Stifel Healthcare Conference 2014, November 18-19, 2014, New York, New York
- 26th Annual Piper Jaffray Healthcare Conference,
December 2-3, 2014, New York, New York
- J.P. Morgan 33rd Annual Healthcare Conference,
January 12-15, 2015, San Francisco, California
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. Composition of matter
patents for BELVIQ are issued in major jurisdictions globally that,
in most cases, are capable of continuing into at least 2023.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's internally discovered drug, BELVIQ®
(lorcaserin HCl), is approved in the
United States, and Arena is focused on discovering,
developing and commercializing additional drugs to address unmet
medical needs. 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® 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
advancement, therapeutic indication, use, safety, efficacy,
mechanism of action, and potential of BELVIQ or lorcaserin,
including when coadministered, for smoking cessation and in
different formulation; advancement of lorcaserin life cycle
programs; progress, potential therapeutic indication and other
aspects of the research and development programs; a selective
serotonin 2C agonist's treatment effect for smoking cessation;
participation at conferences; 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: top-line
results are not comprehensive and are based on a preliminary
analysis of then available data, and findings and conclusions
related to the trial are subject to change following a more
comprehensive review of the data; risks related to commercializing
drugs, including regulatory, manufacturing, supply and marketing
issues and the availability and use of BELVIQ; cash and revenues
generated from BELVIQ, including the impact of competition; Arena's
revenues will be 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 BELVIQ may not be
approved for marketing when expected or ever 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
ability to obtain and defend patents; 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;
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.
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
Net product
sales
|
$ 5,726
|
|
$ 2,011
|
|
$ 12,137
|
|
$ 3,330
|
|
Eisai collaborative
revenue
|
2,133
|
|
973
|
|
14,034
|
|
68,933
|
|
Manufacturing
services
|
158
|
|
443
|
|
1,184
|
|
2,181
|
|
Other collaborative
revenue
|
147
|
|
151
|
|
424
|
|
434
|
|
Total
revenues
|
8,164
|
|
3,578
|
|
27,779
|
|
74,878
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
1,755
|
|
460
|
|
4,049
|
|
1,514
|
|
Cost of manufacturing
services
|
81
|
|
632
|
|
1,124
|
|
3,286
|
|
Research &
development
|
24,508
|
|
14,592
|
|
72,521
|
|
47,428
|
|
General &
administrative
|
8,029
|
|
7,760
|
|
25,198
|
|
23,614
|
|
Total
operating costs & expenses
|
34,373
|
|
23,444
|
|
102,892
|
|
75,842
|
|
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
|
Interest
income
|
16
|
|
28
|
|
69
|
|
68
|
|
Interest
expense
|
(1,723)
|
|
(1,768)
|
|
(5,205)
|
|
(5,333)
|
|
Gain from valuation
of derivative liabilities
|
2,593
|
|
4,100
|
|
3,489
|
|
10,101
|
|
Gain on sale of
available-for-sale securities
|
16,276
|
|
0
|
|
49,553
|
|
0
|
|
Other
|
(1,625)
|
|
306
|
|
(1,240)
|
|
152
|
|
Total interest
& other income, net
|
15,537
|
|
2,666
|
|
46,666
|
|
4,988
|
|
Net income
(loss)
|
$ (10,672)
|
|
$ (17,200)
|
|
$ (28,447)
|
|
$4,024
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
|
Basic
|
$ (0.05)
|
|
$ (0.08)
|
|
$ (0.13)
|
|
$ 0.02
|
|
Diluted
|
$ (0.05)
|
|
$ (0.08)
|
|
$ (0.13)
|
|
$ 0.02
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share:
|
|
|
|
|
|
|
|
|
Basic
|
219,866
|
|
218,316
|
|
219,592
|
|
217,923
|
|
Diluted
|
219,866
|
|
218,316
|
|
219,592
|
|
224,354
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2014
|
|
December 31,
2013
|
|
|
(unaudited)
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 188,328
|
|
$ 221,878
|
|
Accounts
receivable
|
2,914
|
|
10,602
|
|
Inventory
|
11,861
|
|
12,759
|
|
Prepaid
expenses & other current assets
|
5,974
|
|
3,571
|
|
Land, property
& equipment, net
|
75,489
|
|
77,388
|
|
Acquired
technology & other non-current assets
|
12,106
|
|
13,609
|
|
Total
assets
|
$ 296,672
|
|
$ 339,807
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$32,395
|
|
$ 30,827
|
|
Total deferred
revenues
|
114,961
|
|
139,190
|
|
Total
derivative liabilities
|
1,403
|
|
4,892
|
|
Total lease
financing obligations & other long-term liabilities
|
71,627
|
|
73,041
|
|
Total
stockholders' equity
|
76,286
|
|
91,857
|
|
Total
liabilities & stockholders' equity
|
$ 296,672
|
|
$ 339,807
|
|
|
|
|
|
|
1
The Condensed Consolidated Balance Sheet Data has been derived from
the audited financial statements as of that date.
|
Contact: Arena
Pharmaceuticals, Inc.
|
Media Contact: Russo
Partners
|
|
|
Craig M. Audet,
Ph.D., Senior Vice President,
|
David Schull,
President
|
Operations & Head
of Global Regulatory Affairs
|
david.schull@russopartnersllc.com
|
caudet@arenapharm.com
|
858.717.2310
|
858.453.7200, ext.
1612
|
|
|
|
www.arenapharm.com
|
|
SOURCE Arena Pharmaceuticals, Inc.