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, 2011.
"We are excited with our progress this quarter and especially as it relates to our efforts on tasimelteon," said Mihael Polymeropoulos, M.D., President and Chief Executive Officer. "Our programs for both Non-24-Hour Sleep-Wake Disorder and Major Depression continue to move Vanda forward towards our goal of becoming a global leader in the field of chronobiology and the treatment of circadian rhythm disorders."
Key Highlights:
- Vanda recorded third quarter 2011 revenue of $8.0 million including royalties of $1.2 million. Fanapt® prescriptions, as reported by IMS, reached 33,000 in the third quarter of 2011. This represents a 10% increase over second quarter 2011 prescriptions.
- The tasimelteon Non-24-Hour Sleep-Wake Disorder (N24HSWD or Non-24) program continues to advance with two new studies initiated to support registration and is on track for a mid 2013 New Drug Application (NDA) filing.
- The tasimelteon Major Depressive Disorder (MDD) Phase IIb/III study (MAGELLAN) was initiated in September 2011. Vanda expects to report results from the MAGELLAN study in the first half of 2013.
- On October 24, 2011, Vanda announced that Bob Repella joined its management team as Senior Vice President, Chief Commercial Officer.
THIRD QUARTER 2011 REPORTED RESULTS
Total revenues for the third quarter of 2011 were $8.0 million, compared to $7.2 million for the same period in 2010. Third quarter 2011 revenues included $1.2 million related to Fanapt® royalties received from Novartis as compared to $0.5 million for the third quarter of 2010.
Total operating expenses for the third quarter of 2011 were $11.3 million, compared to $6.5 million for the third quarter of 2010. The primary driver of the higher expenses in the current quarter was the new and ongoing support of the tasimelteon Non-24 and MDD clinical studies.
A net loss of $3.1 million was recorded for the third quarter of 2011, compared to net income of $3.2 million for the third quarter of 2010. Diluted net loss per share for the third quarter of 2011 was $0.11, compared to diluted net income of $0.11 per share for the third quarter of 2010.
OPERATIONAL HIGHLIGHTS
Fanapt® prescriptions, as reported by IMS, reached 33,000 in the third quarter of 2011. This represents a 10% increase over second quarter 2011 prescriptions. Since its launch in January 2010, over 145,000 Fanapt® prescriptions have been written in the U.S.
The tasimelteon Non-24 program continues to advance with two new studies initiated to support registration and is on target for a mid 2013 NDA submission. Presently, two phase III pivotal and two safety studies are ongoing. A second phase III pivotal study (3203) enrolled its first patients in September 2011. The 3203 study is a placebo-controlled, randomized withdrawal study to examine the maintenance effect of tasimelteon for the treatment of Non-24. A second safety study (3204) enrolled its first patients in October 2011. The 3204 study is a two year open-label, study in blind subjects with Non-24.
The tasimelteon Phase IIb/III (MAGELLAN) study in MDD was initiated in September 2011. The U.S. based study is expected to enroll 500 patients across 40 sites. The MAGELLAN study has an eight-week treatment period, followed by an optional one-year open-label extension, and includes measures of depression and anxiety symptoms, nighttime and daytime sleep, as well as laboratory measures of the internal body clock. Vanda expects to report results from the MAGELLAN study in the first half of 2013.
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