SAN DIEGO, Nov. 9, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported financial results for the third quarter ended September 30, 2011.
"We are focused on submitting our response to the FDA for the lorcaserin complete response letter around year-end and filing the lorcaserin marketing authorization application with the European Medicines Agency in the first half of next year," stated Jack Lief, Arena's President and Chief Executive Officer. "With our lorcaserin program, we have the potential to provide a completely new treatment option to help patients reduce their weight and improve co-morbid conditions associated with obesity."
Research and development expenses continued to decline in the third quarter of 2011 to $15.0 million, compared to $20.2 million in the third quarter of 2010. Research and development expenses in the first nine months of 2011 declined to $45.6 million from $59.0 million in the first nine months of 2010. These decreases are primarily attributable to Arena's first quarter 2011 workforce reduction and ongoing cost-containment efforts, as well as completion of the Phase 3 lorcaserin clinical trials. General and administrative expenses decreased to $6.0 million in the third quarter of 2011, compared to $6.9 million in the third quarter of 2010, and $19.0 million in the first nine months of 2011, compared to $20.6 million in the first nine months of 2010.
Total interest and other expense in the third quarter of 2011 decreased to $3.4 million, compared to $14.5 million in the third quarter of 2010. Total interest and other expense in the first nine months of 2011 decreased to $21.1 million, compared to $22.4 million in the first nine months of 2010. These decreases are primarily attributable to a reduction in interest expense resulting from Arena's principal prepayments on its Deerfield loan of $20.0 million in January 2011 and $17.7 million in March 2011. Arena's net loss allocable to common stockholders in the third quarter of 2011 was $22.7 million, or $0.16 per share, compared to $36.3 million, or $0.31 per share, in the third quarter of 2010. Including $10.5 million of non-cash debt extinguishment charges and $3.5 million of restructuring charges, Arena's net loss allocable to common stockholders in the first nine months of 2011 was $87.8 million, or $0.64 per share, compared to $96.3 million, or $0.91 per share, in the first nine months of 2010.
At September 30, 2011, cash and cash equivalents totaled $77.9 million and approximately 146.0 million shares of common stock were outstanding.
Lorcaserin Regulatory Update
Other recent developments include:
Scheduled Financial Results Call Arena will host a conference call and webcast to discuss the third quarter 2011 financial results and to provide a business and financial update tomorrow, November 10, 2011, 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 2011 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 Corporate PresentationsArena is planning to present at upcoming investment and industry conferences, including:
About LorcaserinLorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI greater than or equal to 30) or patients who are overweight (BMI greater than or equal to 27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Arena submitted a NDA for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA.
About Arena PharmaceuticalsArena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate is intended for weight management.
Arena Pharmaceuticals® and Arena® are registered service marks of the company.
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 and use, safety, efficacy, tolerability, abuse potential, mechanism of action and potential of lorcaserin; lorcaserin's potency with respect to compounds known to cause valvulopathy; the response to the lorcaserin CRL and the filing of an MAA for lorcaserin, including related plans, activities, progress and timing; the Eisai collaboration and potential activities thereunder; the equity line of credit with Azimuth and potential activities thereunder; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development programs, and ability to 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: the timing of regulatory review and approval is uncertain; regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than we or others do, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the risk that data and other information related to Arena's research and development programs may not meet safety or efficacy requirements or otherwise be sufficient for regulatory approval; Arena's response to the CRL for the lorcaserin NDA or submission of a Marketing Authorization Application for regulatory approval of lorcaserin may not be submitted when anticipated, if at all; unexpected or unfavorable new data; risks related to commercializing new products; Arena's ability to obtain and defend its patents; the timing, success and cost of Arena's research and development programs; 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; Arena's ability to obtain adequate funds; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; and satisfactory resolution of pending and any future 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 endedNine months endedSeptember 30,September 30,2011201020112010(unaudited)(unaudited)RevenuesManufacturing services
$ 1,713$ 1,846$ 4,390$ 5,258Collaborative agreements
1,7465,7836,2537,343 Total revenues
3,4597,62910,64312,601Operating ExpensesCost of manufacturing services
1,5571,8146,2155,309Research and development
14,97820,15545,61658,971General and administrative
003,4670Amortization of acquired technology & other intangibles
1975418191,609 Total operating expenses
22,76129,37275,11386,525Interest and Other Income (Expense)Interest income
(3,211)(6,267)(11,087)(16,198)Gain (Loss) from valuation of derivative liabilities
(233)3,0233874,857Loss on extinguishment of debt
(10)96840988 Total interest and other expense, net
(22,736)(36,266)(85,542)(96,293)Deemed dividend related to beneficial conversion feature of convertible preferred stock
00(2,260)0Net loss allocable to common stockholders
$(22,736)$(36,266)$(87,802)$(96,293)Net loss per share allocable to common stockholders, basic
$(0.16)$(0.31)$(0.64)$(0.91)Net loss per share allocable to common stockholders, diluted
$(0.16)$(0.31)$(0.64)$(0.91)Shares used in calculating net loss per share allocable to common stockholders, basic
145,965117,409136,860105,582Shares used in calculating net loss per share allocable to common stockholders, diluted
145,965117,409136,860105,582Arena Pharmaceuticals, Inc.Condensed Consolidated Balance Sheet Data(In thousands)September 30, 2011December 31, 2010(unaudited)(1)Assets Cash and cash equivalents
$ 77,883$ 150,669 Accounts receivable
2,0153,499 Other current assets
2,4862,638 Land, property & equipment, net
85,24591,533 Acquired technology & other non-current assets
$ 184,999$ 266,362Liabilities and Stockholders' Equity Accounts payable and accrued liabilities
$ 9,608$ 10,680 Total deferred revenues
45,20148,077 Total derivative liabilities
1,2772,271 Total note payable to Siegfried
3,68610,361 Total note payable to Deerfield (2)
13,76937,777 Total lease financing obligations & other long-term liabilities
76,31977,181 Total stockholders' equity
35,13980,015Total liabilities & stockholders' equity
$ 184,999$ 266,362(1)
The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.(2)
The outstanding principal balance of the note payable to Deerfield was $22.3 million at September 30, 2011 and $60.0 million at December 31, 2010.Contacts:
Arena Pharmaceuticals, Inc.
Robert E. Hoffman
Vice President, Finance and Chief Financial Officer858.453.7200, ext. 222
Investor Inquiries: Russo Partners
Cindy McGee, Vice President
619.308.6538Media Inquiries: Russo Partners
David Schull, President
|SOURCE Arena Pharmaceuticals, Inc.|
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