Arena Pharmaceuticals Announces Fourth Quarter and Full Year 2010 Financial Results and Reviews Recent Developments
"Our focus is working with
Arena reported a net loss in the fourth quarter of 2010 of
Research and development expenses continued to decline to
Total interest and other expense increased to
Arena's Recent and Fourth Quarter 2010 Developments
- Received a complete response letter from the
US Food and Drug Administration( FDA) regarding the lorcaserin New Drug Application (NDA), completed an end-of-review meeting with the FDAand reported on Arena and Eisai's plans related to resubmitting the NDA.
- Announced top-line results from the Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial, which evaluated lorcaserin for weight management in obese and overweight patients with type 2 diabetes. Lorcaserin met the three primary efficacy endpoints, and Arena believes the results favorably support the benefit-risk profile of lorcaserin.
- Presented at Obesity 2010, the 28th Annual Scientific Meeting of
The Obesity Society, results from a lorcaserin mechanism of action study conducted at the Pennington Biomedical Research Center. The data showed that lorcaserin reduces energy intake and appetite, and causes weight loss without stimulating energy expenditure.
- Announced the issuance of US Reissue Patent No. RE42,190 with claims to methods of identifying compounds that modulate the activity of the GPR119 receptor, a target for identifying small molecules for the treatment of diabetes.
- Announced the resignation of
Robert E. Hoffman, Vice President, Finance and Chief Financial Officer. Mr. Hoffman will remain in his current role at Arena until the filing of the Form 10-K for the year ended December 31, 2010.
- Committed to a reduction in Arena's US workforce of approximately 25%, or 66 employees, which is expected to be completed around
March 28, 2011. As a result of this workforce reduction, Arena expects to incur restructuring charges, primarily in the first quarter of 2011, of approximately $3.8 millionin connection with one-time employee termination costs.
- Initiated dosing in a Phase 1 clinical trial of APD811, an oral drug candidate Arena discovered that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension. This randomized, double-blind, placebo-controlled trial is evaluating the safety, tolerability and pharmacokinetics of single-ascending doses of APD811.
- Announced that following the completion of a Phase 1 clinical trial program for APD597,
Ortho-McNeil-Janssen Pharmaceuticals, Inc., decided not to advance APD597 and terminated the collaboration effective December 28, 2010. APD597 targets the GPR119 receptor for the treatment of type 2 diabetes, which, along with other compounds and intellectual property, reverted to Arena under the terms of the collaboration. Arena believes APD597 may have utility alone and in combination with a DPP-4 inhibitor for the treatment of type 2 diabetes.
- Announced results from a Phase 1 clinical trial of APD916, a novel drug candidate Arena discovered that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy. In this randomized, double-blind, placebo-controlled trial in 24 healthy volunteers, APD916 demonstrated dose-proportional pharmacokinetic exposure over the tested dose range.
Outlook for 2011
Arena expects to use cash and cash equivalents of approximately
Scheduled Earnings Call
Arena will host both a conference call and webcast to discuss the fourth quarter and full year 2010 financial results and to provide a business and financial update today,
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 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 lorcaserin, which is intended for weight management. Arena's wholly owned subsidiary,
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, mechanism of action, and potential of Arena's drug candidates; the potential of GPR119 and GPR119 agonists; addressing outstanding issues to the
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
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three 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 (Loss) from valuation of derivative liabilities
Loss on extinguishment of debt
Total interest and other expense, net
Net loss per share, basic & diluted
Shares used in calculating net loss per share, basic & diluted
Note: The Condensed Consolidated Statements of Operations has been derived from the audited financial statements for the year ended December 31, 2009 and from the unaudited financial statements for the year ended December 31, 2010.
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
December 31, 2010
December 31, 2009
Cash, cash equivalents & short-term investments
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 **
Total lease financing obligations & other long-term liabilities
Total stockholders' equity
Total liabilities & stockholders' equity
* The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of December 31, 2009 and from the unaudited financial statements as of December 31, 2010.
* * The outstanding principal balance of the note payable to Deerfield was $60.0 million and $90.0 million at December 31, 2010 and December 31, 2009, respectively.
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