ROCKVILLE, Md., May 1 Vanda Pharmaceuticals Inc.(Nasdaq: VNDA), a biopharmaceutical company focused on the development andcommercialization of clinical-stage product candidates for central nervoussystem disorders, today announced financial and operational results for thefirst quarter ended March 31, 2008.
Vanda reported research and development (R&D) expenses in the firstquarter of 2008 of $11.1 million, compared to fourth quarter of 2007 R&Dexpenses of $12.6 million and first quarter of 2007 R&D expenses of $10.6million. The decrease in R&D expenses in the first quarter of 2008 relativeto the fourth quarter of 2007 is primarily attributable to lower tasimelteon(VEC-162) clinical program costs including the ongoing Phase III tasimelteonchronic primary insomnia clinical trial for which Vanda plans to report thetop-line results in June of 2008. The increase in R&D expenses in the firstquarter of 2008 relative to the first quarter of 2007 is primarilyattributable to the same tasimelteon Phase III trial that was initiated inlate 2007.
Net loss was $19.2 million for the first quarter of 2008, compared to$20.7 million in the fourth quarter of 2007 and $15.4 million in the firstquarter of 2007. Net loss per common share for the first quarter of 2008 was$0.72, compared to $0.78 in the fourth quarter of 2007, and $0.61 in the firstquarter of 2007.
As of March 31, 2008, Vanda's cash, cash equivalents, and marketablesecurities totaled approximately $77.0 million. As of March 31, 2008, thecompany had a total of approximately 26.6 million shares of common stockoutstanding.
On September 27, 2007, Vanda announced that it had submitted a New DrugApplication (NDA) to the U.S. Food and Drug Administration (FDA) forFanapta(TM) (formerly referred to as Fiapta), its investigational atypicalantipsychotic for the treatment of schizophrenia. On November 27, 2007 thecompany announced that the FDA had accepted and filed the NDA. Under thePrescription Drug User Fee Act (PDUFA) of 1992, Vanda expects a PDUFA actionon or about July 27, 2008.
As previously announced, Vanda has completed enrollment for itstasimelteon Phase III chronic primary insomnia clinical trial. Vanda expectsto report top-line results in June 2008. Vanda enrolled 324 patients in thetrial, which is a randomized, double-blind, placebo-controlled 35-day study,measuring sleep onset and maintenance, as well as next-day performance.
Analyst Day Announcement
Vanda will host an Analyst Day on Tuesday, May 6, 2008 in Washington, D.C.at the American Psychiatric Association (APA) Annual Meeting, beginning at6:30 p.m. ET. Vanda management and key opinion leaders in the field ofschizophrenia will discuss the company's development and commercial plans andrecently presented poster data.
Interested parties are invited to listen and view a live webcast of thisevent from 6:30 p.m. ET to approximately 8:00 p.m. ET on Tuesday, May 6, 2008on the company's Web site, www.vandapharma.com. Investors should go to theWeb site at least 15 minutes early to register, download, and install anynecessary audio software. A webcast replay will be available for 90 daysfollowing the live event.
The company reaffirms its prior guidance and anticipates that its currentcash balance will be sufficient to fund operations through the Fanapta(TM)PDUFA action date and into the fourth quarter of 2008. Vanda plans to focusits efforts primarily on completing and reporting the top-line results for theongoing tasimelteon Phase III chronic primary insomnia clinical trial andcontinuing essential Fanapta(TM) pre-launch commercial activities.
The company has scheduled a conference call for today, Thursday, May 1,2008 at 10:30 AM ET. During the call, Mihael H. Polymeropoulos, M.D.,President