Arena Pharmaceuticals Announces First Quarter 2011 Financial Results and Recent Developments
"In collaboration with
Research and development expenses continued to decline in the first quarter of 2011 to
Total interest and other expense increased to
Arena's Recent Developments
- Published results from a clinical trial evaluating lorcaserin's abuse potential in the
March 16, 2011, issue of Clinical Pharmacology & Therapeutics. The randomized, placebo-controlled, double-blind, crossover trial was conducted in subjects with a history of recreational drug use and compared the relative abuse potential of lorcaserin against three comparators: placebo, 15 and 30 mg of zolpidem (a schedule IV controlled substance) and 100 mg of ketamine (a schedule III controlled substance).
- Published results from a randomized, placebo-controlled, double-blind mechanism of action study evaluating the contributions of energy intake, appetite and energy expenditure on weight loss with lorcaserin treatment in the
March 2011issue of The Journal of Clinical Endocrinology and Metabolism.
Craig M. Audetjoined Arena as Vice President, Regulatory Affairs. Mr. Audethas 25 years of experience directing global pharmaceutical and medical device registration and marketed product activities, most recently as Vice President, US Regulatory Affairs, for Sanofi-Aventis. Prior to Sanofi-Aventis, he was Senior Director, Global Therapeutic Area Leader, for Pfizer Inc., where he provided strategic direction and oversight across the cardiovascular/metabolic product portfolio.
- Completed a US workforce reduction of approximately 25%, or 65 employees, which Arena expects will result in annual operating cost savings of approximately
- Received gross proceeds of approximately
$35.5 millionfrom the sale of 12,150,000 shares of common stock at $1.46per share and 12,150 shares of Series C Convertible Preferred Stock at $1,460per share to certain Deerfield entities. As part of this transaction, Arena prepaid approximately $17.7 millionof the loan principal that otherwise would have been required to be repaid to Deerfield in June 2013. Arena also reduced the exercise price from $3.45 to $1.68per share and extended the end of the exercise term from June 17, 2013, to June 17, 2015, for approximately 14.4 million of the 16.2 million outstanding warrants to purchase common stock that Deerfield received in connection with a June 2010investment in Arena.
- 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.
Mr. Liefas principal financial officer and Jennifer K. Bielasz, Arena's Senior Director, Accounting and Controller, as principal accounting officer upon the departure of Robert E. Hoffman, Arena's former Vice President, Finance and Chief Financial Officer.
Lorcaserin Regulatory Update
In collaboration with
- A pathology working group has completed a blinded reassessment of the mammary tumors found in the rat carcinogenicity study, and the final report is being prepared;
- Arena expects to initiate preclinical prolactin studies of three months and shorter duration once discussions with the
FDAto finalize protocols are complete;
- Arena and
Eisaibelieve that prolactin studies of three months and shorter duration will be sufficient to test the hypothesis that lorcaserin causes mammary tumors in rats by increasing prolactin effects on the mammary gland, and currently do not anticipate initiating a 12-month study in female rats;
- To address the finding of brain astrocytoma in male rats, Arena has completed dosing, and analyses are ongoing, of a Phase 1 clinical trial that involved collecting cerebrospinal fluid to provide an alternative means of estimating human brain levels at the intended therapeutic doses of lorcaserin; and
- Further assessments of receptor pharmacology and abuse liability are ongoing.
Depending on the results of these and other ongoing and planned activities, as well as any new guidance from the
Updated 2011 Financial Guidance
In 2011, Arena expects to use cash and cash equivalents of approximately
Scheduled Earnings Call
Arena will host a conference call and webcast to discuss the first quarter 2011 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 "
Upcoming Corporate Presentations
Arena is planning to present at upcoming conferences and meetings, including:
Bank of America Merrill Lynch2011 Health Care Conference, May 10-12, 2011, Las Vegas, Nevada
- ECO 2011, the 18th
European Congress on Obesity, May 25-28, 2011, Istanbul, Turkey
- American Diabetes Association's 71st Scientific Sessions,
June 24-28, 2011, San Diego, California
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, lorcaserin, 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 response to the CRL for the lorcaserin NDA, including related plans, activities, hypotheses, strategies, expectations and timing, including with regard to the sufficiency of planned activities and the potential submission of such response; the advancement, therapeutic indication and use, safety, efficacy, tolerability and mechanism of action of lorcaserin; the advancement of Arena's earlier-stage programs and reporting of results; financial guidance; costs savings related to Arena's workforce reduction and cost-containment efforts; 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 and 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 and diluted
Shares used in calculating net loss per share allocable to common stockholders, basic and diluted
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
March 31, 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**
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 that date.
** The outstanding principal balance of the note payable to Deerfield was $22.3 million and $60.0 million at March 31, 2011 and December 31, 2010, respectively.
News Provided by Acquire Media