Exhibit 99.1

 

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Vanda Pharmaceuticals Reports Fourth Quarter 2015 and Full Year

2015 Financial Results

 

  HETLIOZ® net product sales grew to $15.1 million in the fourth quarter 2015

 

  Full year 2015 total revenues grew to $109.9 million

WASHINGTON – February 10, 2016 – Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:

VNDA), today announced financial and operational results for the fourth quarter and full year ended December 31, 2015.

“2015 was a transformational year for Vanda with the continued growth of HETLIOZ in the U.S., and the European market approval of HETLIOZ for Non-24,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. “The addition of Fanapt to our U.S. product portfolio builds on this success and underscores Vanda’s commitment to bringing important treatment options to patients.”

Key Highlights:

HETLIOZ® (tasimelteon)

 

    HETLIOZ® net product sales grew to $15.1 million in the fourth quarter of 2015, a 30% increase compared to $11.7 million in the third quarter of 2015 and a 152% increase compared to $6.0 million reported in the fourth quarter of 2014.

 

    HETLIOZ® net product sales were $44.3 million for the full year 2015, a 246% increase compared to $12.8 million reported for the full year 2014.

 

    During the fourth quarter of 2015, Vanda initiated an open label interventional study of tasimelteon for the treatment of Smith-Magenis Syndrome. A placebo controlled, Phase III study is planned to begin in the second half of 2016.

 

    During the fourth quarter of 2015, Vanda completed an observational study of Jet Lag Disorder. A placebo controlled, Phase III study is planned to begin in the second half of 2016.

Fanapt® (iloperidone)

 

    Fanapt® net product sales were $16.7 million for the fourth quarter of 2015, compared to $16.7 million in the third quarter of 2015.

 

    Fanapt® net product sales were $65.6 million for the full year 2015, compared to $65.0 million in 2014, as reported by Novartis AG.

 

    In December 2015, the Marketing Authorization Application for oral Fanaptum® tablets was accepted for evaluation by the European Medicines Agency for the treatment of schizophrenia in adults.

 

    The FDA review of the supplemental New Drug Application for Fanapt® for the maintenance treatment of schizophrenia in adults is ongoing. The FDA has set a PDUFA goal date in May 2016.

Cash, cash equivalents and marketable securities (Cash) were $143.2 million as of December 31, 2015, representing an increase to Cash of $13.4 million in 2015.

 

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The following information was filed by Vanda Pharmaceuticals Inc. (VNDA) on Wednesday, February 10, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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