ROCKVILLE, Md., Aug. 4, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced financial and operational results for the second quarter and six months ended June 30, 2011.
"We are pleased with our progress towards our vision of building a CNS specialty pharmaceutical company. Fanapt® scripts in the U.S. continued to grow, and we have made advances towards the globalization of the franchise. We are excited about the prospects of our tasimelteon programs in both Non-24 and major depression, which are currently underway," said Mihael Polymeropoulos, M.D., President and Chief Executive Officer.
Key Highlights:
- Vanda recorded second quarter 2011 revenue of $7.4 million including royalties of $0.8 million. Second quarter sales of Fanapt® as reported by Novartis included a $2.7 million cumulative adjustment to gross to net sales reserves that resulted in approximately $270 thousand less in royalties to Vanda in the period.
- Fanapt® prescriptions, as reported by IMS, reached 30,000 in the second quarter of 2011. This represents a 17% increase over first quarter 2011 prescriptions.
- On July 22, 2011, the European Medicines Agency (EMA) notified Vanda that it had accepted for evaluation the Marketing Authorization Application (MAA) for oral iloperidone tablets.
- Vanda announced commercialization agreements for two Latin American markets. On July 11, 2011, Vanda entered into an exclusive license agreement with Probiomed S.A. de C.V. (Probiomed) for the commercialization of Fanapt® in Mexico. On August 1, 2011, Vanda entered into an exclusive license agreement with Biotoscana Farma S.A. (Biotoscana) for the commercialization of Fanapt® in Argentina.
- The first tasimelteon Non-24-Hour Sleep-Wake Disorder (N24HSWD or Non-24) Phase III pivotal study continues its enrollment. New international clinical sites were added during the quarter.
SECOND QUARTER 2011 REPORTED RESULTS
Total revenues for the second quarter of 2011 were $7.4 million, compared to $8.3 million for the same period in 2010. Second quarter 2011 revenues included $0.8 million related to Fanapt® royalties received from Novartis as compared to $0.1 million for the second quarter of 2010. Second quarter 2011 sales of Fanapt® as reported by Novartis included a $2.7 million cumulative adjustment to gross to net sales reserves that resulted in approximately $270 thousand less in royalties to Vanda in the period. Second quarter 2010 revenues also included one-time product sales to Novartis of $1.5 million. Total operating expenses for the second quarter of 2011 were $8.9 million, compared to $7.1 million for the second quarter of 2010. The primary driver of the higher expenses in the second quarter of 2011 was the ongoing support of the tasimelteon N24HSWD clinical studies.
A net loss of $1.3 million was recorded for the second quarter of 2011, compared to net income of $1.3 million for the second quarter of 2010. Diluted net loss per share for the second quarter of 2011 was $0.05, compared to diluted net income of $0.04 per share for the second quarter of 2010.
