ROCKVILLE, Md., May 1 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced financial and operational results for the first quarter ended March 31, 2008.
Vanda reported research and development (R&D) expenses in the first quarter of 2008 of $11.1 million, compared to fourth quarter of 2007 R&D expenses of $12.6 million and first quarter of 2007 R&D expenses of $10.6 million. The decrease in R&D expenses in the first quarter of 2008 relative to the fourth quarter of 2007 is primarily attributable to lower tasimelteon (VEC-162) clinical program costs including the ongoing Phase III tasimelteon chronic primary insomnia clinical trial for which Vanda plans to report the top-line results in June of 2008. The increase in R&D expenses in the first quarter of 2008 relative to the first quarter of 2007 is primarily attributable to the same tasimelteon Phase III trial that was initiated in late 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 first quarter 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 first quarter of 2007.
As of March 31, 2008, Vanda's cash, cash equivalents, and marketable securities totaled approximately $77.0 million. As of March 31, 2008, the company had a total of approximately 26.6 million shares of common stock outstanding.
On September 27, 2007, Vanda announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Fanapta(TM) (formerly referred to as Fiapta), its investigational atypical antipsychotic for the treatment of schizophrenia. On November 27, 2007 the company announced that the FDA had accepted and filed the NDA. Under the Prescription Drug User Fee Act (PDUFA) of 1992, Vanda expects a PDUFA action on or about July 27, 2008.
As previously announced, Vanda has completed enrollment for its tasimelteon Phase III chronic primary insomnia clinical trial. Vanda expects to report top-line results in June 2008. Vanda enrolled 324 patients in the trial, 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 at 6:30 p.m. ET. Vanda management and key opinion leaders in the field of schizophrenia will discuss the company's development and commercial plans and recently presented poster data.
Interested parties are invited to listen and view a live webcast of this event from 6:30 p.m. ET to approximately 8:00 p.m. ET on Tuesday, May 6, 2008 on the company's Web site, www.vandapharma.com. Investors should go to the Web site at least 15 minutes early to register, download, and install any necessary audio software. A webcast replay will be available for 90 days following the live event.
The company reaffirms its prior guidance and anticipates that its current cash balance will be sufficient to fund operations through the Fanapta(TM) PDUFA action date and into the fourth quarter of 2008. Vanda plans to focus its efforts primarily on completing and reporting the top-line results for the ongoing tasimelteon Phase III chronic primary insomnia clinical trial and continuing 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 and CEO, and Steven A. Shallcross, Sr. Vice President and CFO, will discuss quarterly results and other corporate activities. Investors can call 1-866-510-0710 (domestic) and 1-617-597-5378 (international) prior to the 10:30 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay of the call will be available Thursday, May 1, 2008, at 12:30 PM ET and will be accessible until Thursday, May 8, 2008, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access number is 34135192.
The conference call will be broadcast simultaneously on the company's Web site, http://www.vandapharma.com . Investors should click on the Investor Relations tab and are advised to go to the Web site at least 15 minutes early to register, download, and install any necessary software. The call will also be archived on the Vanda Web site for a period of 30 days, through May 30, 2008.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates. Vanda's lead product candidate, Fanapta(TM) (iloperidone), is a compound for the treatment of schizophrenia and bipolar disorder, for which Vanda has recently submitted an NDA to the FDA. Vanda's second product candidate, tasimelteon (VEC-162), is a compound for the treatment of sleep and mood disorders, which is currently in Phase III for chronic primary insomnia. Vanda's third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness in Phase II. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com .
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," and similar expressions or words, identify forward- looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vanda is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in the company's forward-looking statements include, among others: delays in the completion of Vanda's clinical trials; a failure of Vanda's product candidates to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements; a lack of acceptance of Vanda's product candidates in the marketplace, or a failure to become or remain profitable; Vanda's inability to obtain the capital necessary to fund its research and development activities; Vanda's failure to identify or obtain rights to new product candidates; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; a loss of any of Vanda's key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda's products under its license and sublicense agreements and other factors that are described in the "Risk Factors" section (Item 1A) of Vanda's annual report on Form 10-K for the year ended December 31, 2007 (File No. 000-51863). In addition to the risks described above and in Item 1A of Vanda's annual report on Form 10-K, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Vanda Pharmaceuticals Inc.