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 DevelopmentsBELVIQ® (lorcaserin HCl) CIV US Commercial Update
BELVIQ Additional Developments
Research & Development
Second Quarter 2014 Financial Results
Scheduled Conference Call and WebcastArena 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 ParticipationArena is planning to participate at upcoming investment and industry conferences, including:
About BELVIQ® (lorcaserin HCl) CIVBELVIQ 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:
Limitations of Use:
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 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 PharmaceuticalsArena 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 StatementsCertain 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 endedSix months endedJune 30,June 30,2014201320142013(unaudited)(unaudited)RevenuesNet product sales
,319Eisai collaborative revenue
5789731,0261,738Other collaborative revenue
140170277283 Total revenues
12,80168,92719,61571,300Operating Costs & ExpensesCost of product sales
1,4635812,2941,054Cost of manufacturing services
5471,0091,0432,654Research & development
27,02518,82848,01332,836General & administrative
9,1328,60317,16915,854 Total operating costs & expenses
38,16729,02168,51952,398Interest & Other Income (Expense)Interest income
(1,735)(1,778)(3,482)(3,565)Gain from valuation of derivative liabilities
1,0062,1428966,001Gain on sale of available-for-sale securities
274(186)385(154) Total interest & other income, net
32,84619431,1292,322Net income (loss)
7,480$ 40,100$ (17,775)$21,224Net income (loss) per share:Basic
.09Shares used in calculating net income (loss) per share:Basic
225,341224,528219,453224,551Arena Pharmaceuticals, Inc.Condensed Consolidated Balance Sheet Data(In thousands)June 30, 2014December 31, 2013(unaudited)1Assets Cash & cash equivalents
$ 200,798$ 221,878 Short-term investments, available-for-sale
18,3130 Accounts receivable
12,59412,759 Prepaid expenses & other current assets
4,6793,571 Land, property & equipment, net
77,90877,388 Acquired technology & other non-current assets
$ 334,672$ 339,807Liabilities & Stockholders' Equity Accounts payable & accrued liabilities
$ 26,569$ 30,827 Total deferred revenues
129,132139,190 Total derivative liabilities
3,9964,892 Total lease financing obligations & other long-term liabilities
72,13373,041 Total stockholders' equity
102,84291,857Total liabilities & stockholders' equity
$ 334,672$ 339,8071The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.
Contact: Arena Pharmaceuticals, Inc.
Media Contact: Russo PartnersCraig M. Audet, Ph.D., Senior Vice President,
David Schull, PresidentOperations and Head of Global Regulatory Affairs
858.717.2310858.453.7200, ext. 1612www.arenapharm.com
|SOURCE Arena Pharmaceuticals, Inc.|
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