Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the second quarter and six months ended June 30, 2012.
Key Highlights:
• The tasimelteon Non-24-Hour Disorder (Non-24) program continues to advance towards the goal of a projected mid-2013 New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA).
• The SET Phase III efficacy study for Non-24 is fully enrolled and Vanda expects to report top-line results by the end of 2012.  Vanda expects to report top-line results from the RESET Phase III efficacy study in the first quarter of 2013.
• The tasimelteon MAGELLAN Phase IIb/III efficacy study for Major Depressive Disorder (MDD) is ongoing and Vanda expects to report top-line results in the first half of 2013.
• Vanda recorded second quarter 2012 revenue of $8.4 million including royalties of $1.7 million.  Fanapt®prescriptions, as reported by IMS, reached 37,000 for the second quarter of 2012.   This represents a 5% increase over first quarter 2012 prescriptions and a 24% increase over second quarter 2011 prescriptions.
SECOND QUARTER 2012 REPORTED RESULTS
Total revenues for the second quarter of 2012 were $8.4 million, compared to $7.4 million for the same period in 2011.  Second quarter 2012 revenues included $1.7 million in Fanapt royalties received from Novartis as compared to royalties of $0.8 million for the second quarter of 2011.  
Total operating expenses for the second quarter of 2012 were $16.5 million, compared to $8.9 million for the second quarter of 2011.  The primary drivers of the higher expenses in the second quarter of 2012 were the ongoing support of the tasimelteon Non-24 and MDD clinical studies and the $1 million upfront payment to Eli Lilly & Company in connection with the licensing of VLY-686, a Phase II ready NK-1R antagonist.
Vanda recorded a net loss of $8.0 million for the second quarter of 2012, compared to a net loss of $1.3 millionfor the second quarter of 2011.  Diluted net loss per share for the second quarter of 2012 was $0.28, compared to diluted net loss per share of $0.05 for the second quarter of 2011.

OPERATIONAL HIGHLIGHTS  
The tasimelteon Non-24 program continues to advance towards the goal of a projected mid-2013 NDA filing with the FDA.  Vanda is in continuing discussions with the FDA to confirm the path and requirements for this regulatory submission.  The SET Phase III efficacy study is fully enrolled and Vanda expects to report top-line results by the end of 2012.  Vanda expects to report top-line results from the RESET Phase III efficacy study in the first quarter of 2013.
Vanda presented new data from the tasimelteon Non-24 program at SLEEP, the annual meeting of the Associated Professional Sleep Societies (APSS) and the Society for Research on Biological Rhythm (SRBR) annual conference.  At APSS, data was reported that showed seventy percent of totally blind individuals with sleep complaints, who enrolled in the ongoing SET study, suffered from Non-24 disorder.  This data confirmed previous literature that there is a high prevalence of Non-24 in the totally blind population.
The tasimelteon MAGELLAN Phase IIb/III efficacy study for MDD is ongoing and Vanda expects to report top-line results in the first half of 2013. 
The review of Vanda's Marketing Authorization Application (MAA) for oral iloperidone tablets in the European Union is ongoing.  In July 2012, the Committee for Medicinal Products for Human Use (CHMP) provided Vanda with the Day 180 List of Outstanding Issues.  Vanda expects to be granted an extension to reply by mid-October 2012 and will prepare to participate in an oral hearing in November 2012 as it continues to evaluate its European strategy.
Second quarter 2012 sales of Fanapt were reported by Novartis to be $17.0 million.  Fanapt prescriptions, as reported by IMS, reached 37,000 for the second quarter of 2012.  This represents a 5% increase over first quarter 2012 prescriptions and a 24% increase over second quarter 2011 prescriptions.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders.  For more on Vanda, please visit http://www.vandapharma.com.