Key Highlights:
- Vanda records year to date revenue of $20.7 million including year to date royalties of $2.1 million.
- Fanapt® prescriptions continued to increase month-over-month during the second quarter of 2010. Monthly prescriptions of Fanapt®, as reported by IMS, increased from approximately 500 in February 2010 (the first full month of sales) to over 4,000 in June of 2010.
- On August 3, 2010, the U.S. Patent and Trademark Office (USPTO) issued a patent for a microsphere, long-acting injectable (depot) formulation of iloperidone. The USPTO has informed Vanda that the patent term adjustment included an additional 605 days, making the patent expiration date June 27, 2023.
- Phase III studies of tasimelteon for the treatment of Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception to be initiated in the third quarter of 2010.
Total revenue for the second quarter of 2010 was $8.3 million, compared to $12.4 million for the first quarter of 2010 and $0 for the second quarter of 2009. Total operating expenses for the second quarter of 2010 were $7.1 million, compared to $6.3 million for the first quarter of 2010 and $12.4 million for the second quarter of 2009. Net income was $1.3 million for the second quarter of 2010 compared to net income of $0.5 million for the first quarter of 2010 and a net loss of $12.4 million for the second quarter of 2009.
Vanda's cash, cash equivalents, and marketable securities as of June 30, 2010 totaled approximately $207.1 million. Approximately 28.0 million shares of Vanda common stock were outstanding as of June 30, 2010. Basic and diluted net income per common share for the second quarter of 2010 were $0.05 and $0.04, respectively, compared to basic and diluted net income per common share of $0.02 for the first quarter of 2010 and a basic and diluted net loss per common share of $0.46 for the second quarter of 2009.
Year to date June 30, 2010 Key Financial Figures(1) | |||||
YTD 6/30/10($) | YTD 6/30/09($) | Change ($) | Change (%) | ||
Total revenues | 20,711,000 | - | 20,711,000 | N/A | |
R&D expenses | 4,444,000 | 9,529,000 | (5,085,000) | -53% | |
G&A expenses | 5,331,000 | 9,212,000 | (3,881,000) | -42% | |
Employee non-cash stock-based compensation | 2,733,000 | 5,057,000 | (2,324,000) | -46% | |
Net income (loss) before tax provision | 7,436,000 | (18,896,000) | N/A | N/A | |
Tax provision | 5,628,000 | - | 5,628,000 | N/A | |
Net income (loss) | 1,809,000 | (18,896,000) | - | N/A | |
Basic net income per share attributable to common stockholders | 0.07 | (0.71) | - | N/A | |
Diluted net income per share attributable to common stockholders | 0.06 | (0.71) | - | N/A | |
Second Quarter 2010 Key Financial Figures(1) | |||||
Q2 2010 ($) | Q1 2010 ($) | Change ($) | Change (%) | ||
Total revenues | 8,290,000 | 12,421,000 | (4,131,000) | -33% | |
R&D expenses | 2,404,000 | 2,041,000 | 363,000 | 18% | |
G&A expenses | 2,842,000 | 2,489,000 | 353,000 | 14% | |
Employee non-cash stock-based compensation | 1,644,000 | 1,089,000 | 555,000 | 51% | |
Net income before tax provision | 1,242,000 | 6,195,000 | (4,953,000) | -80% | |
Tax (benefit) provision | (38,000) | 5,665,000 | N/A | N/A | |
Net income | 1,279,000 | 529,000 | 750,000 | 142% | |
Basic net income per share attributable to common stockholders | 0.05 | 0.02 | 0.03 | 150% | |
Diluted net income per share attributable to common stockholders | 0.04 | 0.02 | 0.02 | 100% | |
Total cash and marketable securities | 207,117,000 | 202,424,000 | 4,693,000 | 2% | |
(1) Unaudited | |||||
OPERATIONAL HIGHLIGHTS
Year-to-date net sales of Fanapt® were reported by Novartis to be approximately $21.4 million comprised of $20.7 million in the first quarter of 2010 and $0.7 million in the second quarter of 2010. Vanda is encouraged by the continuing growth in total number of monthly prescriptions, as reported by IMS, and by the strengthened promotional launch of Fanapt® since the approval of marketing materials by the FDA in May 2010. Fanapt® monthly prescriptions, as reported by IMS, increased from approximately 500 in February 2010 (the first full month of sales) to over 4,000 in June of 2010.
On February 23, 2010, the USPTO issued a notice of allowance for Vanda's patent application of a microsphere, long-acting injectable (depot) formulation of iloperidone. Subsequently, on August 3, 2010, the USPTO informed Vanda that the patent has been issued with a patent term adjustment of an additional 605 days, extending the patent expiration date to June 27, 2023. Novartis is responsible for the further development of the depot formulation in the U.S. and Canada. Vanda has retained the rights for the development and commercialization of the iloperidone depot formulation outside the U.S. and Canada. Vanda also continues to
