SAN DIEGO, May 7 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported financial results for the first quarter ended March 31, 2008.
Total revenues in the first quarter of 2008 were $2.6 million, compared to $4.9 million in the first quarter of 2007, and included $2.0 million in revenue under Arena's contract manufacturing agreement with Siegfried Ltd and $0.6 million in patent reimbursements from Arena's collaborations with Merck & Co., Inc. and Ortho-McNeil Pharmaceutical, Inc. Arena reported a net loss allocable to common stockholders in the first quarter of 2008 of $55.0 million, or $0.75 per share, compared to a net loss allocable to common stockholders in the first quarter of 2007 of $32.4 million, or $0.53 per share.
"In the first quarter of 2008, we purchased certain pharmaceutical manufacturing assets from Siegfried and secured Siegfried as a supplier of lorcaserin for our planned NDA submission in 2009 and for the potential partnering and commercialization of the drug candidate. Additionally, lorcaserin passed the month-12 ESMB review of echocardiographic data, APD125, our insomnia drug candidate, entered a Phase 2b trial and APD791, our drug candidate for arterial thrombosis, entered a Phase 1b trial," stated Jack Lief, Arena's President and Chief Executive Officer. "This is a productive start to the year, and we look forward to the results from our ongoing clinical trials and advancing our pipeline of innovative therapeutics."
Research and development expenses totaled $47.6 million in the first quarter of 2008, compared to $35.8 million in the first quarter of 2007. This increase in research and development expenses is primarily attributable to increased clinical development costs related to the Phase 3 clinical program for lorcaserin hydrochloride, Arena's drug candidate for the treatment of obesity. Research and development expenses included $1.0 million in non-cash, share-based compensation expense in each of the quarters ended March 31, 2008 and 2007. General and administrative expenses totaled $8.9 million in the first quarter of 2008, compared to $4.9 million in the first quarter of 2007. This increase in general and administrative expenses is primarily attributable to increases in patent costs and personnel-related expenses. Total patent costs, including patent costs related to partnered programs, increased by $1.7 million in the first quarter of 2008 compared to the first quarter of 2007. General and administrative expenses in the first quarter of 2008 included $1.4 million in non-cash, share-based compensation expense, compared to $0.9 million in the first quarter of 2007.
Cash, cash equivalents and short-term investments totaled $333.6
million at March 31, 2008. Approximately 73.8 million shares of common
stock were outstanding at March 31, 2008.
Arena's First Quarter Highlights
o Initiated a Phase 2b clinical trial of APD125, an oral drug candidate
intended to reduce insomnia symptoms and improve sleep maintenance and
quality. This Phase 2b trial is a double-blind, randomized,
placebo-controlled subjective study that is expected to enroll
approximately 675 patients in about 70 clinical sites in the United
o Reported that, following a planned review by an independent
Echocardiographic Safety Monitoring Board, or ESMB, Arena is continuing
BLOOM, a pivotal clinical trial evaluating the efficacy and safety of
lorcaserin for the treatment of obesity. The ESMB's review of unblinded
echocardiographic data performed after all patients had the opportunity
to complete 12 months of dosing in the trial confirmed that differences,
if any, in the rates of valvulopathy (as defined by the Food and Drug
Administration, or FDA) in patients treated with lorcaserin and in the
control group did not meet the ESMB's predetermined stopping criteria.
o Announced the initiation of a Phase 1 clinical trial of a second
generation oral niacin receptor agonist intended for the treatment of
atherosclerosis in partnership with Merck & Co., Inc.
o Entered into strategic agreements with Siegfried Ltd primarily related
to the manufacturing of lorcaserin for Arena's planned New Drug
Application submission to the FDA and for commercialization of
lorcaserin after regulatory marketing approval. The agreements include
the purchase of certain drug product manufacturing and packaging
facility assets, including fixtures, equipment, other personal property
and real estate assets, located in Zofingen, Switzerland.
o Reported positive Phase 1a clinical trial results of APD791, Arena's
oral, internally discovered drug candidate intended for the treatment of
arterial thrombosis, and initiated a Phase 1b clinical trial to further
evaluate this drug candidate.
o Announced that initial clinical trial results for APD668, an oral drug
candidate discovered by Arena and being investigated for the treatment
of type 2 diabetes in partnership with Ortho-McNeil Pharmaceutical,
Inc., suggest that the Glucose-Dependent Insulinotropic Receptor, or
GDIR, improves glucose control in patients with type 2 diabetes. Based
on the data from those studies, Ortho-McNeil put APD668 on hold and
advanced a potentially more potent Arena-discovered GDIR agonist into
Scheduled Earnings Call
Arena will host both a conference call and webcast to discuss the first quarter 2008 financial results and to provide a corporate update today, Wednesday, May 7, 2008, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Jack Lief, President and Chief Executive Officer and Robert E. Hoffman, Vice President, Finance and Chief Financial Officer will host the conference call.
The conference call may be accessed by dialing 866.356.3095 for domestic callers and 617.597.5391 for international callers. Please specify to the operator that you would like to join the "Arena First Quarter Earnings Call." The participant code for the call is 65484912. The conference call will be webcast live under the investor relations section of Arena's website at http://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 Presentations
Arena is scheduled to present at several investment and industry
conferences through June 2008, including:
o Bank of America 2008 Health Care Conference, May 13-15, 2008,
Las Vegas, Nevada
o Citigroup's Global Healthcare Conference, May 21-22, 2008,
New York, New York
o The Seventh Annual Needham & Company, LLC Biotechnology and Medical
Technology Conference, June 11-12, 2008, New York, New York
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for the treatment of obesity. Arena's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc. and Ortho-McNeil Pharmaceutical, Inc.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
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 protocol, design, scope, enrollment
and other aspects of current and planned clinical trials and other studies
of Arena's or its collaborators' product candidates and compounds; the
future results of clinical trials; the tolerability, side effects, efficacy
and potential of Arena's or its collaborators' product candidates and
compounds; an NDA submission for lorcaserin and the potential partnering
and commercialization of the drug candidate; expectations relating to the
agreements and Arena's relationship with Siegfried; the advancement and
content of Arena's pipeline; and other statements about Arena's outlook,
strategy, internal and partnered 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, clinical trials and studies may
not proceed at the time or in the manner Arena expects or at all, the
results of clinical trials or preclinical studies may not be predictive of
future results, Arena's ability to partner lorcaserin, APD125, APD791 or
other of its compounds or programs, the timing, success and cost of Arena's
research, out-licensing endeavors and clinical trials, Arena's ability to
obtain additional financing, Arena's ability to obtain and defend its
patents, the timing and receipt of payments and fees, if any, from Arena's
collaborators, and Arena's ability to redeem with common stock any
outstanding shares of its series B convertible preferred stock. 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
Contacts: Jack Lief Mary Claire Duch
President and CEO WeissComm Partners
David Walsey 212.301.7228
Director, Corporate Communications
Arena Pharmaceuticals, Inc.
858.453.7200, ext. 1682
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three months ended March 31,
Contract manufacturing $2,019 $ -
Collaborative agreements 590 4,911
Total revenues 2,609 4,911
Cost of contract manufacturing 2,330 -
Research and development 47,565 35,755
General and administrative 8,861 4,923
Amortization of acquired technology 384 384
Total operating expenses 59,140 41,062
Interest and other income, net 2,066 4,256
Net loss (54,465) (31,895)
Dividends on redeemable convertible
preferred stock (540) (514)
Net loss allocable to common
stockholders $(55,005) $(32,409)
Net loss per share allocable to common
stockholders, basic and diluted $(0.75) $(0.53)
Shares used in calculating net loss per
share allocable to common stockholders,
basic and diluted 73,605 60,734
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
March 31, 2008 December 31, 2007
Cash, cash equivalents and
short-term investments $333,636 $398,185
Accounts receivable 2,398 1,901
Other current assets 8,938 9,162
Land, property and equipment, net 92,704 65,940
Acquired technology and other
non-current assets 26,857 12,318
Total assets $464,533 $487,506
Liabilities and Stockholders' Equity
Accounts payable, accrued expenses
and accrued compensation $38,345 $30,058
Total deferred revenues 4,049 4,049
Total lease financing obligations
and other long-term liabilities 72,067 63,100
Redeemable convertible preferred
stock 54,462 53,922
Total stockholders' equity 295,610 336,377
Total liabilities and stockholders'
equity $464,533 $487,506
Note: The Condensed Consolidated Balance Sheet Data has been derived from
the audited financial statements as of that date.
|SOURCE Arena Pharmaceuticals, Inc.|
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