SAN DIEGO, May 11, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today provided a corporate
update and reported financial results for the first quarter ended
March 31, 2015.
"We are pleased with the progress we have made thus far in 2015,
including the approval and launch of BELVIQ in South Korea, our entry into a collaboration
for the development and commercialization of nelotanserin, and the
favorable results generated from our investigational clinical
trials for APD334 for inflammatory bowel diseases, APD371 for pain
or fibrotic diseases and BELVIQ XR, a once-daily extended release
formulation of BELVIQ for weight management," stated Jack Lief,
Arena's President and Chief Executive Officer. "We continue to
advance our clinical pipeline toward proof of concept and beyond in
areas of unmet medical need as we support efforts to bring BELVIQ
to additional patients in new territories."
First Quarter and Recent Developments
BELVIQ® (lorcaserin HCl) Commercial
Update
- IMS Health estimates that approximately 169,000 prescriptions
for BELVIQ were filled in the United
States in the first quarter of 2015, representing growth in
total prescriptions of approximately 13.7% compared to the previous
quarter.
- Eisai recorded net US product sales for BELVIQ of $12.8 million during the first quarter of
2015.
- BELVIQ was approved for marketing for weight management in
South Korea, and Ildong commenced
marketing in late February 2015. In
connection with the approval, Arena received a milestone payment of
$3.0 million from Ildong. From launch
through March 31, patients filled
prescriptions totaling 766,350 tablets, which equates to
approximately 12,770 one-month prescriptions. Arena recorded
$2.2 million net South Korea product sales for BELVIQ during
the first quarter of 2015.
- Announced that the US Patent and Trademark Office granted Arena
US Patent No. 8,999,970 for BELVIQ, which describes a method for
selecting appropriate patients based on renal function. Arena
expects this additional patent to potentially extend the
exclusivity of BELVIQ until 2033.
Arena Research & Development
- Arena and Roivant Sciences Ltd. entered into a Development,
Marketing and Supply Agreement for nelotanserin, Arena's internally
discovered inverse agonist of the serotonin 2A receptor. The
agreement grants Roivant exclusive worldwide rights to develop and
commercialize nelotanserin, subject to regulatory approval. Arena
will receive a $4.0 million upfront
payment and is eligible to receive regulatory and development
milestone payments, a portion of net sales and other payments.
- Announced results from a Phase 1 single-ascending dose clinical
trial of APD371, a highly selective and potent agonist of the
cannabinoid 2 (CB2) receptor in development as a potential
treatment for pain and fibrotic diseases.
- Announced the completion of two registrational clinical trials
for an extended release formulation of lorcaserin, planned to be
marketed as BELVIQ XR®. A New Drug
Application is intended to be filed with the US Food and Drug
Administration later this year.
- Initiated patient dosing in a Phase 2 clinical trial of
ralinepag, an oral, non-prostanoid prostacyclin (IP) receptor
agonist intended for the treatment of pulmonary arterial
hypertension.
- Announced results from a Phase 1b multiple-ascending dose
clinical trial for APD334, an oral drug modulator of the
sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential
treatment of autoimmune diseases.
First Quarter 2015 Financial Results
- Revenues totaled $12.3 million,
including $6.6 million in net product
sales of BELVIQ, and a $3.0 million
milestone for approval of BELVIQ in South
Korea.
- Research and development expenses totaled $22.0 million.
- General and administrative expenses totaled $8.4 million.
- Net loss was $24.3 million, or
$0.10 per share.
- At March 31, 2015, cash and cash
equivalents totaled $241.0 million,
including net proceeds of $100.7
million from the common stock offering in January 2015.
- At March 31, 2015, approximately
242.0 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 first quarter 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'
First Quarter 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.
Upcoming Conference Participation
Arena is planning to participate at upcoming investment and
industry conferences, including:
- Bank of America Merrill Lynch 2015 Health Care Conference,
May 12-14, 2015, Las Vegas, Nevada
- Jefferies Global Healthcare Conference, June 1-4, 2015, New
York, New York
- JMP Securities Life Sciences Conference, June 23-24, 2015, New
York, New York
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. BELVIQ is approved for
weight management by the US Food and Drug Administration and the
Ministry of Food and Drug Safety in South
Korea. Eisai Inc. and Ildong Pharmaceutical Co., Ltd.,
market and distribute BELVIQ in the
United States and South
Korea, respectively, and Arena manufactures and supplies the
finished commercial product from its facility in Switzerland.
Arena owns composition of matter patents for lorcaserin that
have been issued in major jurisdictions globally that, in most
cases, are capable of continuing into 2023. Arena has filed
applications for patent term extension on patents directed to
composition of matter in the United
States, which, if granted, would extend the composition of
matter patent term into 2026 or potentially into 2027. In addition,
the US Patent and Trademark Office recently granted Arena a
method-of-treatment patent, US Patent No. 8,999,970, which
describes a method for selecting appropriate patients based on
renal function for BELVIQ and may extend exclusivity for BELVIQ
until 2033.
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 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
significance of the progress in 2015; the commercialization of
BELVIQ; rights, obligations, activities and expectations with
respect to collaborative agreements; the therapeutic indication,
use, safety, efficacy, mechanism of action and potential of BELVIQ;
the results, progress, therapeutic indication, regulatory
application and approval, potential and other aspects of research
and development programs; advancing the clinical pipeline,
including toward proof of concept and beyond; bringing BELVIQ to
additional patients and supporting related efforts; patent
coverage, including potential exclusivity; participation at
conferences; 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; 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.
|
Media Contact: Russo
Partners
|
|
|
Scott A.
Rieger
|
David
Schull
|
Senior Director,
Investor Relations
|
President
|
srieger@arenapharm.com
|
david.schull@russopartnersllc.com
|
858.453.7200, ext.
1374
|
858.717.2310
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operations
|
(In thousands, except
per share amounts)
|
|
|
|
|
Three months
ended
March 31,
|
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
Net product
sales
|
$ 6,618
|
|
$ 2,882
|
|
Other Eisai
collaborative revenue
|
2,136
|
|
3,347
|
|
Toll
manufacturing
|
346
|
|
448
|
|
Other collaborative
revenue
|
3,156
|
|
137
|
|
Total
revenues
|
12,256
|
|
6,814
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
Cost of product
sales
|
3,191
|
|
831
|
|
Cost of toll
manufacturing
|
402
|
|
496
|
|
Research &
development
|
21,968
|
|
20,988
|
|
General &
administrative
|
8,439
|
|
8,037
|
|
Total
operating costs & expenses
|
34,000
|
|
30,352
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
Interest
income
|
34
|
|
29
|
|
Interest
expense
|
(1,696)
|
|
(1,747)
|
|
Loss from valuation
of derivative liabilities
|
(1,549)
|
|
(110)
|
|
Other
|
660
|
|
111
|
|
Total interest
& other expense, net
|
(2,551)
|
|
(1,717)
|
|
Net loss
|
$(24,295)
|
|
$(25,255)
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
Basic
|
$ (0.10)
|
|
$ (0.12)
|
|
Diluted
|
$ (0.10)
|
|
$ (0.12)
|
|
|
|
|
|
|
Shares used in
calculating net loss per share:
|
|
|
|
|
Basic
|
235,703
|
|
219,222
|
|
Diluted
|
235,703
|
|
219,222
|
|
|
|
|
|
|
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2015
|
|
December 31,
2014
|
|
|
(unaudited)
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 240,981
|
|
$ 163,209
|
|
Accounts
receivable
|
12,209
|
|
3,712
|
|
Inventory
|
11,386
|
|
10,831
|
|
Prepaid
expenses & other current assets
|
4,048
|
|
4,144
|
|
Land, property
& equipment, net
|
82,096
|
|
82,919
|
|
Intangibles
& other non-current assets
|
11,569
|
|
11,570
|
|
Total
assets
|
$ 362,289
|
|
$ 276,385
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 43,441
|
|
$ 49,158
|
|
Total deferred
revenues
|
117,326
|
|
108,302
|
|
Derivative
liabilities
|
2,023
|
|
474
|
|
Total lease
financing obligations & other long-term liabilities
|
70,565
|
|
71,106
|
|
Total
stockholders' equity
|
128,934
|
|
47,345
|
|
Total
liabilities & stockholders' equity
|
$ 362,289
|
|
$ 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,
visit:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-provides-corporate-update-and-reports-first-quarter-2015-financial-results-300081230.html
SOURCE Arena Pharmaceuticals, Inc.