SAN DIEGO, May 12, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today provided a corporate
update and reported financial results for the first quarter ended
March 31, 2014.
"We are off to a productive start in 2014 with significant new
marketing initiatives for BELVIQ® for chronic weight management,
the advancement of our lorcaserin life-cycle management programs
and the development of our internally discovered pipeline," said
Jack Lief, Arena's President and Chief Executive Officer.
"Prescriptions for BELVIQ increased 31% in the first quarter over
the previous quarter, and Eisai continues to boost its investment
in key strategic areas."
First Quarter and Recent Developments
BELVIQ® (lorcaserin HCl) CIV US Commercial
Update
- Approximately 77,000 prescriptions for BELVIQ were filled in
the first quarter of 2014, according to IMS Health, representing
growth of approximately 31% in total prescriptions as compared to
the previous quarter.
- Eisai recorded net product sales for BELVIQ of $8.4 million in the first quarter of 2014.
- Eisai announced plans to add another 200 representatives to its
sales force for BELVIQ by July 2014,
increasing the number of representatives to approximately 600.
Eisai believes this expansion of the sales force will enable them
to reach approximately 90,000 physicians in the United States. This increase is in
addition to the 200 sales representatives for BELVIQ that Eisai
added around the end of 2013.
- Eisai announced that its continued work to expand reimbursement
has resulted in additional insurance coverage for BELVIQ. According
to Fingertip Formulary, the number of insured commercial lives in
the United States with access to
BELVIQ is now estimated to exceed 60%. While the exact coverage for
BELVIQ varies by each patient's insurance plan, this improved
access means more patients will receive coverage support from their
health plan or pharmacy benefit manager.
- Eisai launched a national television advertising campaign for
BELVIQ that illustrates the struggles many people face with
appetite and body weight. The television advertisement is airing on
numerous networks, including Lifetime, Oxygen and AMC, and presents
BELVIQ as a targeted approach to weight loss, that, when combined
with diet and increased activity, may help patients lose weight and
keep it off.
- Eisai Laboratorios Ltda. filed for marketing authorization of
BELVIQ as a treatment for chronic weight management in Brazil. In connection with the filing, Arena
achieved a $0.5 million milestone
payment from Eisai.
Research & Development
- Eisai completed enrollment in a 12-week pilot study of
lorcaserin and phentermine when co-administered. The primary
endpoint of this study is safety.
- Arena initiated dosing in a 12-week randomized, double-blind
and placebo-controlled Phase 2 clinical trial that will enroll
approximately 600 active smokers to evaluate lorcaserin as a
potential aid to smoking cessation.
- Ildong Pharmaceutical Co., Ltd., initiated dosing in a Phase 1
multiple-ascending dose clinical trial of temanogrel, an orally
available inverse agonist of the serotonin 2A receptor intended for
the treatment of thrombotic diseases.
First Quarter 2014 Financial Results
- Revenues totaled $6.8 million,
including $2.9 million in net product
sales of BELVIQ, of which $2.7
million represented 31.5% of Eisai's net product sales and
$0.2 million related to redemptions
of the 15-day free voucher.
- Research and development expenses totaled $21.0 million.
- General and administrative expenses totaled $8.0 million.
- Net loss was $25.3 million, or
$0.12 per share.
- At March 31, 2014, cash, cash
equivalents and short-term investments available-for-sale totaled
$256.5 million.
- At March 31, 2014, approximately
219.5 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 first quarter 2014 financial results
today at 5:00 p.m. Eastern Time
(2:00 p.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' First 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:
- Jefferies 2014 Global Healthcare Conference, June 2-5, 2014, New
York, New York
- American Diabetes Association's 74th Scientific
Sessions, June 13-17, 2014,
San Francisco, California
- Wells Fargo Securities Healthcare Conference, June 17-18, 2014, Boston, Massachusetts
- Piper Jaffray Heartland Summit, August
6-7, 2014, Minneapolis,
Minnesota
About BELVIQ® (lorcaserin HCl) CIV
BELVIQ (pronounced BEL-VEEK) is approved by the US Food and Drug
Administration for chronic weight management and is available by
prescription in the United States.
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. For more information about
BELVIQ, click here for the full Prescribing Information or visit
www.BELVIQ.com.
BELVIQ is indicated 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.
Arena has granted exclusive marketing and distribution rights to
Eisai for most territories worldwide, to Ildong Pharmaceutical Co.,
Ltd., for South Korea, and to CY
Biotech Company Limited for Taiwan. Arena plans to enter into additional
collaborations to commercialize BELVIQ in Australia, New
Zealand and Israel.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. BELVIQ® (lorcaserin HCl), Arena's internally
discovered drug, is approved in the
United States and is under review for regulatory approval in
additional territories. 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;
productivity of the start in 2014; significance of marketing
initiatives; advancement of lorcaserin life-cycle management
programs; development of Arena's pipeline; Eisai's investment,
including the strategic importance of the investment areas; the
sales force for BELVIQ, including plans to increase the number of
representatives and related timing, significance and other
expectations; reimbursement coverage for BELVIQ, including efforts
to expand coverage, additional coverage, patient access and
significance; regulatory review and approval and commercialization
of BELVIQ; the protocol, design, scope, enrollment, timing,
expectations and other aspects of Arena's or its collaborators'
studies or trials; plans to enter into additional collaborations
and the commercialization of BELVIQ in additional territories;
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
March 31,
|
|
2014
|
|
2013
|
|
(unaudited)
|
Revenues
|
|
|
|
Net product
sales
|
$
2,882
|
|
$ 0
|
Eisai collaborative
revenue
|
3,347
|
|
1,495
|
Manufacturing
services
|
448
|
|
765
|
Other collaborative
revenue
|
137
|
|
113
|
Total
revenues
|
6,814
|
|
2,373
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
Cost of product
sales
|
831
|
|
473
|
Cost of manufacturing
services
|
496
|
|
1,645
|
Research &
development
|
20,988
|
|
14,008
|
General &
administrative
|
8,037
|
|
7,251
|
Total
operating costs & expenses
|
30,352
|
|
23,377
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
Interest
income
|
29
|
|
24
|
Interest
expense
|
(1,747)
|
|
(1,787)
|
Gain (Loss) from
valuation of derivative liabilities
|
(110)
|
|
3,859
|
Other
|
111
|
|
32
|
Total interest
& other income (expense), net
|
(1,717)
|
|
2,128
|
Net loss
|
$(25,255)
|
|
$(18,876)
|
|
|
|
|
Net loss per
share:
|
|
|
|
Basic
|
$
(0.12)
|
|
$
(0.09)
|
Diluted
|
$
(0.12)
|
|
$
(0.09)
|
|
|
|
|
Shares used in
calculating net loss per share:
|
|
|
|
Basic
|
219,222
|
|
217,503
|
Diluted
|
219,222
|
|
217,503
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
March 31,
2014
|
|
December 31,
2013
|
|
(unaudited)
|
|
1
|
Assets
|
|
|
|
Cash &
cash equivalents
|
$ 203,272
|
|
$ 221,878
|
Short-term
investments, available-for-sale
|
53,234
|
|
0
|
Accounts
receivable
|
1,552
|
|
10,602
|
Inventory
|
11,947
|
|
12,759
|
Prepaid
expenses & other current assets
|
6,363
|
|
3,571
|
Land, property
& equipment, net
|
78,046
|
|
77,388
|
Acquired
technology & other non-current assets
|
13,282
|
|
13,609
|
Total
assets
|
$ 367,696
|
|
$ 339,807
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
Accounts
payable & accrued liabilities
|
$
29,412
|
|
$
30,827
|
Total deferred
revenues
|
134,618
|
|
139,190
|
Total
derivative liabilities
|
5,002
|
|
4,892
|
Total lease
financing obligations & other long-term liabilities
|
72,609
|
|
73,041
|
Total
stockholders' equity
|
126,055
|
|
91,857
|
Total
liabilities & stockholders' equity
|
$ 367,696
|
|
$ 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.
Craig Audet, Senior
Vice President,
Operations and Head
of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext.
1612
|
Media Contact: Russo
Partners
David Schull,
President
david.schull@russopartnersllc.com
858.717.2310
|
SOURCE Arena Pharmaceuticals, Inc.