Vanda third quarter total revenue increases to $7.2 million

Nov 3 2010

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 third quarter and nine months ended September 30, 2010.

Key Highlights:

• Vanda records year-to-date revenue of $28.0 million including year-to-date royalties of $2.6 million.  
• Fanapt® prescriptions continued to increase month-over-month during the third quarter of 2010. Monthly prescriptions of Fanapt®, as reported by IMS, increased from over 4,000 in June of 2010 to over 6,000 in September of 2010.
• Enrollment began in tasimelteon Study VP-VEC-162-3201, in the treatment of Non-24-Hour Sleep/Wake Disorder in blind individuals with no light perception. Top-line results are expected in late 2011.  
• On October 29, 2010, Vanda received certification for qualified research and development investments under the Internal Revenue Service's Therapeutic Discovery Project Credit Program and will receive a cash payment of approximately $0.5 million.

Total revenue for the third quarter of 2010 was $7.2 million, compared to $8.3 million for the second quarter of 2010 and $0 for the third quarter of 2009. Total operating expenses for the third quarter of 2010 were $6.5 million, compared to $7.1 million for the second quarter of 2010 and $7.7 million for the third quarter of 2009. Net income was $3.2 million for the third quarter of 2010, compared to net income of $1.3 million for the second quarter of 2010 and a net loss of $7.7 million for the third quarter of 2009.  

Vanda's cash, cash equivalents, and marketable securities as of September 30, 2010 totaled approximately $202.1 million.  Approximately 28.0 million shares of Vanda common stock were outstanding as of September 30, 2010. Basic and diluted net income per common share for the third quarter of 2010 was $0.11, compared to basic and diluted net income per common share of $0.05 and $0.04, respectively, for the second quarter of 2010 and basic and diluted net loss per common share of $0.28 for the third quarter of 2009.

OPERATIONAL HIGHLIGHTS  

Year-to-date net sales of Fanapt® were reported by Novartis to be approximately $26.3 million, comprised of $20.7 million in the first quarter of 2010, $0.7 million in the second quarter of 2010 and $4.9 million in the third quarter of 2010.  Vanda is encouraged by the continuing growth in the total number of monthly prescriptions, as reported by IMS. According to IMS, monthly prescriptions of Fanapt® increased from over 4,000 in June of 2010 to over 6,000 in September of 2010.

The development of the iloperidone depot formulation is ongoing with Vanda retaining the rights for commercialization outside the U.S. and Canada.  On October 28, 2010, the U.S. Patent and Trademark Office (USPTO) informed Vanda that it has granted an additional patent term adjustment of 59 days, making the total extension 664 days and making the patent expiration date August 25, 2023.

Vanda continues to explore the regulatory path and commercial opportunity for Fanapt® oral formulation outside of the U.S. and Canada.  On November 1, 2010, Australia's Department of Health and Ageing -- Therapeutic Goods Administration, accepted for evaluation Vanda's application for marketing approval.

Enrollment has begun in Study VP-VEC-162-3201, a 160-patient randomized controlled trial of tasimelteon versus placebo in the treatment of Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception. Top-line results are expected in late 2011. The trial has a 6-month treatment period and includes measures of both nighttime and daytime sleep, as well as laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle.

Vanda has also initiated a one-year safety study of tasimelteon for the treatment of N24HSWD.  This is an open-label safety study that will enroll approximately 140 patients with N24HSWD.  Vanda plans to conduct additional clinical trials over the next one to two years to support U.S. and European regulatory submissions.  Tasimelteon was granted orphan drug designation by the FDA on January 19, 2010. The application for orphan designation from the European Medicines Agency is pending.

On October 29, 2010, Vanda received certification for qualified research and development investments under the Internal Revenue Service's Therapeutic Discovery Project Credit Program and will receive a cash payment of approximately $0.5 million.

SOURCE Vanda Pharmaceuticals Inc.