ROCKVILLE, Md., Feb. 14, 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 fourth quarter and twelve months ended December 31, 2011.
Key Highlights:
- Initial clinical data in the RESET study revealed potential of tasimelteon to reset the body clock in Non-24-Hour Sleep-Wake Disorder (Non-24-Hour Disorder).
- The tasimelteon Non-24-Hour Disorder program continues to advance towards a projected mid-2013 New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA). Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012.
- 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 fourth quarter 2011 revenue of $8.4 million including royalties of $1.6 million. Full year 2011 Fanapt® prescriptions, as reported by IMS, exceeded 120,000, compared to approximately 55,000 for 2010.
FULL YEAR 2011 REPORTED RESULTS
Total revenues for the full year 2011 were $31.3 million, compared to $35.7 million for 2010. Full year 2011 revenues included $4.5 million in Fanapt® royalties received from Novartis, as compared to $3.1 million for the prior year. Both 2011 and 2010 revenues include $26.8 million recognized from the $200.0 million upfront payment previously received from Novartis for Fanapt® U.S. and Canadian rights. 2010 full year revenues also included $5.8 million in product sales to Novartis and grant revenue.
Total operating expenses for 2011 were $42.0 million, compared to $26.9 million for 2010. The primary driver of the higher expenses in 2011 was the ongoing support of the tasimelteon Non-24-Hour Disorder and MDD clinical studies.
Vanda recorded a net loss of $9.8 million for 2011, compared to net income of $7.2 million for 2010. Diluted net loss per share for 2011 was $0.35, compared to diluted net income per share of $0.25 for 2010.
Vanda’s cash, cash equivalents and marketable securities as of December 31, 2011 totaled $167.9 million.
FOURTH QUARTER 2011 REPORTED RESULTS
Total revenues for the fourth quarter of 2011 were $8.4 million, compared to $7.8 million for 2010. Fourth quarter 2011 revenues included $1.6 million in Fanapt® royalties received from Novartis as compared to royalties of $0.5 million for the fourth quarter of 2010.
Total operating expenses for the fourth quarter of 2011 were $14.3 million, compared to $7.0 million for the fourth quarter of 2010. The primary driver of the higher expenses in the fourth quarter of 2011 was the initiation and ongoing support of the tasimelteon Non-24-Hour Disorder and MDD clinical studies.
Vanda recorded a net loss of $5.5 million for the fourth quarter of 2011, compared to net income of $2.2 million for the fourth quarter of 2010. Diluted net loss per share for the fourth quarter of 2011 was $0.20, compared to diluted net income of $0.08 per share for the fourth quarter of 2010.
