ROCKVILLE, Md., Feb. 14 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. , 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 fourth quarter and fiscal year ended December 31, 2007.
Vanda reported research and development (R&D) expenses in the fourth quarter of 2007 of $12.6 million, compared to third quarter of 2007 R&D expenses of $13.9 million and fourth quarter of 2006 R&D expenses of $7.9 million. The decrease in R&D expenses between the third and fourth quarters is primarily attributable to costs associated with the ongoing Phase III VEC-162 chronic insomnia clinical trial being offset by a non-recurring third quarter milestone charge of $5.0 million for the Fiapta(TM) New Drug Application (NDA) submission in September 2007. The increase in R&D expenses in the fourth quarter of 2007 relative to the fourth quarter of 2006 is primarily attributable to the same VEC-162 Phase III chronic insomnia clinical trial that was initiated in late 2007. For the full year of 2007, total R&D expenses were $47.2 million compared to $52.1 million during 2006. Total expenses for the fourth quarter of 2007 were $22.0 million, compared to $23.5 million in the third quarter of 2007 and $12.4 million in the fourth quarter of 2006. For the full year of 2007, total expenses were $80.0 million, compared to $65.7 million in 2006.
Net loss was $20.7 million for the fourth quarter of 2007, compared to $21.9 million in the third quarter of 2007 and $11.9 million in the fourth quarter of 2006. Net loss per common share for the fourth quarter of 2007 was $0.78, compared to $0.82 in the third quarter of 2007, and $0.54 in the fourth quarter of 2006.
As of December 31, 2007, Vanda’s cash, cash equivalents, and marketable securities totaled approximately $93.2 million. As of December 31, 2007, the company had a total of approximately 26.6 million shares of common stock outstanding.
“I am extremely pleased with the successful submission and acceptance of the Fiapta(TM) NDA filing in 2007. This important achievement would not have been possible without the commitment and dedication of the Vanda team,” stated Mihael Polymeropoulos, M.D., President and CEO of Vanda. “I am looking forward to an exciting 2008 during which we expect the results from our VEC-162 Phase III chronic insomnia clinical trial and the PDUFA action for Fiapta(TM).”
OPERATIONAL HIGHLIGHTS
Iloperidone
On September 27, 2007 Vanda announced that it had submitted an NDA to the U.S. Food and Drug Administration (FDA) for Fiapta(TM), 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.
VEC-162
Vanda has completed enrollment for its VEC-162 Phase III chronic 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.
The company anticipates that its current cash balance will be sufficient to fund operations through the Fiapta(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 VEC-162 Phase III chronic insomnia clinical trial and continuing essential Fiapta(TM) pre-launch commercial activities.
CONFERENCE CALL
The company has scheduled a conference call for today, Thursday, February 14, 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 1-866-578-5747 (domestic) and 1-617-213-8054 (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, February 14, 2008, at 12:30 PM ET and will be accessible until Thursday, February 21, 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 16341258.
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 March 15, 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, Fiapta(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, VEC-162, is a compound for the treatment of sleep and mood disorders, which is currently in Phase III for chronic 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.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Vanda’s plans for its product candidates. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “should,” and “could,” and similar expressions or words identify forward-looking statements. Such 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 Vanda’s forward-looking statements include, among others, a failure of Vanda’s product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company’s products or to comply with ongoing regulatory requirements, a lack of acceptance of Vanda’s product candidates in the marketplace, a failure of the company to become or remain profitable, Vanda’s inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company’s key scientists or management personnel, and other factors that are described in the “Risk Factors” section (Part II, Item 1A) of Vanda’s report on Form 10-Q for the quarter ended September 30, 2007 (File No. 000-51863). No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
CONTACT: Steven A. Shallcross, Senior Vice President & CFO of Vanda
Pharmaceuticals Inc., +1-240-599-4500, sshallcross@vandapharma.com
Web site: http://www.vandapharma.com//
