WASHINGTON, Aug. 2, 2012 /PRNewswire/ -- 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.
- 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 million for 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.
Year to date June 30, 2012 Key Financial Figures1