SAN DIEGO, Aug. 1, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today provided a corporate
update and reported financial results for the second quarter ended
June 30, 2014.
"We have continued to see encouraging advancements in the US
commercialization of BELVIQ, including a 43% quarter-over-quarter
increase in estimated total prescriptions and estimated total per
week prescriptions surpassing the 10,000 mark," said Jack Lief,
Arena's President and Chief Executive Officer. "Other recent
notable achievements consist of advancing our internally discovered
pipeline and lorcaserin life-cycle management programs, and
establishing a marketing and supply agreement for BELVIQ in
Israel."
Second Quarter and Recent Developments
BELVIQ® (lorcaserin HCl) CIV US Commercial
Update
- IMS Health estimates that approximately 110,000 prescriptions
for BELVIQ were filled in the second quarter of 2014, representing
growth of approximately 43% in total prescriptions as compared to
the previous quarter.
- Eisai recorded net product sales for BELVIQ of $9.9 million in the second quarter of 2014.
- Eisai completed its planned increase of more than 200 new sales
representatives in its Metabolic Business Unit, increasing the
sales force for BELVIQ by 50% to approximately 600. Eisai expects
this further expansion of the sales force will enable them to
increase their reach to a total of approximately 92,000 physicians
in the United States.
BELVIQ Additional Developments
- Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH,
and Teva Pharmaceutical Industries Ltd.'s local Israeli
subsidiary entered into a marketing and supply agreement for BELVIQ
in Israel. Under the agreement,
Arena granted the rights to market and distribute BELVIQ in the
territory for weight loss or weight management in obese and
overweight patients, subject to regulatory approval of BELVIQ by
the State of Israel Ministry of Health.
- Arena and Eisai participated at the American Diabetes
Association's 74th Scientific Sessions in San Francisco, California, including giving
one oral presentation, Lorcaserin Can Improve Weight Loss in
Patients with Prediabetes and Reduce Progression to Diabetes in
Obese and Overweight Patients, and presenting two posters,
Change in A1C in Overweight Patients with Type 2 Diabetes with
the Healthy Lifestyle Program Used in the Lorcaserin Phase 3
Trials and Lorcaserin Free Plasma Levels at Recommended Dose
are Sufficient to Activate Serotonin 2C but not 2A or 2B
Receptors.
- An article based on post-hoc analyses from the three pivotal
Phase 3 trials of lorcaserin entitled, "Early Weight Loss While on
Lorcaserin, Diet, and Exercise as a Predictor of Week 52
Weight-Loss Outcomes," was published in the online issue of
Obesity, the official peer reviewed journal of The Obesity
Society.
- BELVIQ was nominated by the Galien Foundation and Awards
Committee for the 2014 Prix Galien USA Award in the Best Pharmaceutical Agent
category.
Research & Development
- Arena and Eisai completed enrollment of a 12-week, Phase 2,
proof-of-concept trial of approximately 600 active smokers to
evaluate lorcaserin as an aid to smoking cessation, and completed
enrollment in a pilot study of approximately 225 patients to
evaluate the safety of co-administration of lorcaserin with
phentermine. Results are expected for both of these studies around
the end of the year.
- Arena initiated dosing in a Phase 1 multiple-ascending dose
trial of APD334, a novel, oral drug candidate that targets the
sphingosine 1-phosphate subtype 1 (S1P1) receptor, to
evaluate the compound for the treatment of a number of autoimmune
diseases.
- Arena was granted US Patent No. 8,778,950, entitled
"Cannabinoid Receptor Modulators," by the United States Patent and
Trademark Office for APD371, an agonist of the cannabinoid receptor
2 (CB2). Arena is exploring several potential indications for
APD371, including chronic pain, and is currently conducting a Phase
1 program.
Second Quarter 2014 Financial Results
- Revenues totaled $12.8 million,
including $3.5 million in net product
sales of BELVIQ, of which $3.1
million represented 31.5% of Eisai's net product sales and
$0.4 million related to redemptions
of the 15-day free trial voucher.
- Research and development expenses totaled $27.0 million.
- General and administrative expenses totaled $9.1 million.
- Gain on sale of available-for-sale securities of $33.3 million related to Arena's investment in
TaiGen.
- Net income was $7.5 million, or
$0.03 per share.
- At June 30, 2014, cash, cash
equivalents and short-term investments available-for-sale totaled
$219.1 million.
- At June 30, 2014, approximately
219.8 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 second 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' Second 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:
- Piper Jaffray Heartland Summit, August
6-7, 2014, Minneapolis,
Minnesota
- Bank of America Merrill Lynch Global Healthcare Conference,
September 17-19, 2014, London, England
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. 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;
commercialization of BELVIQ, including the expansion of the sales
force, other advancements and related significance and
expectations; advancing the pipeline; the significance of the
post-hoc analyses and their results; rights and obligations under
the marketing and supply agreement with Teva's subsidiary and
related expectations and activities; the protocol, design, scope,
enrollment, timing, expectations and other aspects of Arena's or
its collaborators' studies or trials; 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; 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
|
|
Six months
ended
|
|
June 30,
|
|
June 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
(unaudited)
|
|
(unaudited)
|
Revenues
|
|
|
|
|
|
|
|
Net product
sales
|
$ 3,529
|
|
$ 1,319
|
|
$ 6,411
|
|
$ 1,319
|
Eisai collaborative
revenue
|
8,554
|
|
66,465
|
|
11,901
|
|
67,960
|
Manufacturing
services
|
578
|
|
973
|
|
1,026
|
|
1,738
|
Other collaborative
revenue
|
140
|
|
170
|
|
277
|
|
283
|
Total
revenues
|
12,801
|
|
68,927
|
|
19,615
|
|
71,300
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
Cost of product
sales
|
1,463
|
|
581
|
|
2,294
|
|
1,054
|
Cost of manufacturing
services
|
547
|
|
1,009
|
|
1,043
|
|
2,654
|
Research &
development
|
27,025
|
|
18,828
|
|
48,013
|
|
32,836
|
General &
administrative
|
9,132
|
|
8,603
|
|
17,169
|
|
15,854
|
Total
operating costs & expenses
|
38,167
|
|
29,021
|
|
68,519
|
|
52,398
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
Interest
income
|
24
|
|
16
|
|
53
|
|
40
|
Interest
expense
|
(1,735)
|
|
(1,778)
|
|
(3,482)
|
|
(3,565)
|
Gain from valuation
of derivative liabilities
|
1,006
|
|
2,142
|
|
896
|
|
6,001
|
Gain on sale of
available-for-sale securities
|
33,277
|
|
0
|
|
33,277
|
|
0
|
Other
|
274
|
|
(186)
|
|
385
|
|
(154)
|
Total interest
& other income, net
|
32,846
|
|
194
|
|
31,129
|
|
2,322
|
Net income
(loss)
|
$ 7,480
|
|
$ 40,100
|
|
$ (17,775)
|
|
$21,224
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
Basic
|
$ 0.03
|
|
$ 0.18
|
|
$ (0.08)
|
|
$ 0.10
|
Diluted
|
$ 0.03
|
|
$ 0.18
|
|
$ (0.08)
|
|
$ 0.09
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share:
|
|
|
|
|
|
|
|
Basic
|
219,682
|
|
217,940
|
|
219,453
|
|
217,723
|
Diluted
|
225,341
|
|
224,528
|
|
219,453
|
|
224,551
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
June 30,
2014
|
|
December 31,
2013
|
|
(unaudited)
|
|
1
|
Assets
|
|
|
|
Cash &
cash equivalents
|
$ 200,798
|
|
$ 221,878
|
Short-term
investments, available-for-sale
|
18,313
|
|
0
|
Accounts
receivable
|
7,350
|
|
10,602
|
Inventory
|
12,594
|
|
12,759
|
Prepaid
expenses & other current assets
|
4,679
|
|
3,571
|
Land, property
& equipment, net
|
77,908
|
|
77,388
|
Acquired
technology & other non-current assets
|
13,030
|
|
13,609
|
Total
assets
|
$ 334,672
|
|
$ 339,807
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 26,569
|
|
$ 30,827
|
Total deferred
revenues
|
129,132
|
|
139,190
|
Total
derivative liabilities
|
3,996
|
|
4,892
|
Total lease
financing obligations & other long-term liabilities
|
72,133
|
|
73,041
|
Total
stockholders' equity
|
102,842
|
|
91,857
|
Total
liabilities & stockholders' equity
|
$ 334,672
|
|
$ 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 and 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.