WASHINGTON, May 8, 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 first quarter ended March 31, 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). Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012.
Initial clinical data in the RESET study revealed potential of tasimelteon to reset the body clock in Non-24.
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.
On April 16, 2012, Vanda announced that it had obtained exclusive world-wide rights from Eli Lilly and Company to develop and commercialize VLY-686, a small molecule neurokinin 1 receptor (NK-1R) antagonist for all human indications. VLY-686 is a Phase II ready program.
- Vanda recorded first quarter 2012 revenue of $8.1 million including royalties of $1.5 million. Fanapt® prescriptions, as reported by IMS, reached 35,000 for the first quarter of 2012. This represents a 39% increase over first quarter 2011 prescriptions.
FIRST QUARTER 2012 REPORTED RESULTS
Total revenues for the first quarter of 2012 were $8.1 million, compared to $7.5 million for the same period in 2011. First quarter 2012 revenues included $1.5 million in Fanapt® royalties received from Novartis as compared to royalties of $0.9 million for the first quarter of 2011.
Total operating expenses for the first quarter of 2012 were $16.5 million, compared to $7.5 million for the first quarter of 2011. The primary driver of the higher expenses in the first quarter of 2012 was the ongoing support of the tasimelteon Non-24 and MDD clinical studies.
Vanda recorded a net loss of $8.0 million for the first quarter of 2012, compared to net income of $0.1 million for the first quarter of 2011. Diluted net loss per share for the first quarter of 2012 was $0.28, compared to diluted net income of $0.00 per share for the first quarter of 2011.
