Arena Pharmaceuticals Announces Second Quarter 2011 Financial Results
"We view the results from the Pathology Working Group's re-adjudication and the CSF study as important steps toward our planned response to the lorcaserin complete response letter," stated
Research and development expenses continued to decline in the second quarter of 2011 to
Total interest and other expense in the first half of 2011 increased to
- Announced results from a Pathology Working Group's, or PWG, re-adjudication of female rat mammary tumor diagnoses from a two-year rat carcinogenicity study of lorcaserin. Arena convened the PWG in response to the lorcaserin complete response letter, or CRL, which questioned the certainty of the female rat mammary tumor classifications.
- Announced the completion of a clinical study that measured lorcaserin concentrations in human cerebrospinal fluid, or CSF, and plasma and related data analyses. The study was conducted to provide additional data that may be informative for determining the human relevance of the observation of brain astrocytoma in male rats.
- Published results from the lorcaserin Phase 3 BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) clinical trial in the
Journal of Clinical Endocrinology and Metabolism. The randomized, double-blind and placebo-controlled trial evaluated lorcaserin versus placebo over a one-year treatment period in 4,008 obese patients as well as overweight patients with at least one weight-related co-morbid condition.
- Announced results from a Phase 1 clinical trial of APD811, an orally bioavailable agonist of the prostacyclin receptor that is intended for the treatment of pulmonary arterial hypertension. The randomized, double-blind and placebo-controlled trial evaluated the safety, tolerability and pharmacokinetics of single doses of APD811.
- Presented three posters of lorcaserin data from the Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) clinical trial at the American Diabetes Association's 71st Scientific Sessions.
meta-analyses of the three trials in the lorcaserin Phase 3 clinical trial program - BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM and BLOOM-DM - at ECO 2011, the 18th
European Congress on Obesity.
Scheduled Financial Results Call
Arena will host a conference call and webcast to discuss the second quarter 2011 financial results and to provide a business and financial update today at
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 "
Upcoming Corporate Presentations
Arena is planning to present at upcoming conferences and meetings, including Obesity 2011, the 29th Annual Scientific Meeting of
Arena 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.
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 and use, safety, efficacy, tolerability, mechanism of action and potential of lorcaserin; the significance of the PWG's re-adjudication and the CSF study, including the potential use of the results; the response to the CRL for the lorcaserin NDA, including related plans, activities and timing; the therapeutic indication of APD811; and Arena's views, 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
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three months ended
Six months ended
Cost of manufacturing services
Research and development
General and administrative
Amortization of acquired technology & other intangibles
Total operating expenses
Interest and Other Income (Expense)
Gain from valuation of derivative liabilities
Loss on extinguishment of debt
Total interest and other expense, net
Deemed dividend related to beneficial conversion feature of convertible preferred stock
Net loss allocable to common stockholders
Net loss per share allocable to common stockholders, basic
Net loss per share allocable to common stockholders, diluted
Shares used in calculating net loss per share allocable to common stockholders, basic
Shares used in calculating net loss per share allocable to common stockholders, diluted
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
June 30, 2011
December 31, 2010
Cash and cash equivalents
Other current assets
Land, property & equipment, net
Acquired technology & other non-current assets
Liabilities and Stockholders' Equity
Accounts payable and accrued liabilities
Total deferred revenues
Total derivative liabilities
Total note payable to Siegfried
Total note payable to Deerfield (2)
Total lease financing obligations & other long-term liabilities
Total stockholders' equity
Total liabilities & stockholders' equity
(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 June 30, 2011 and $60.0 million at December 31, 2010.
Contact: Arena Pharmaceuticals, Inc.
Media Contact: Russo Partners
David Schull, President
President and CEO
Manager, IR and Corporate Communications
Anthony J. Russo, Ph.D., CEO
858.453.7200, ext. 1479
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