Exhibit 99.1

 

LOGO

Vanda Pharmaceuticals Reports Fourth Quarter 2018 and Full Year

2018 Financial Results

 

   

Full year 2018 total revenues grew to $193.1 million, a 17% increase compared to 2017

 

   

Full year 2019 total revenues expected to be between $215 million and $225 million

WASHINGTON – February 13, 2019 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:

VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2018.

“The combination of strong commercial performance and positive clinical results has set 2018 apart as a transformative year for Vanda,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. “The tradipitant clinical programs in gastroparesis and atopic dermatitis have emerged as potentially significant drivers of future growth with the possibility of bringing new treatment options to millions of patients.”

Key Financial Highlights:

 

   

Total net product sales from HETLIOZ® and Fanapt® were $53.0 million in the fourth quarter of 2018, an 8% increase compared to $49.1 million in the third quarter of 2018 and a 20% increase compared to $44.3 million in the fourth quarter of 2017.

 

   

HETLIOZ® net product sales were $32.4 million in the fourth quarter of 2018, an 8% increase compared to $29.9 million in the third quarter of 2018 and a 30% increase compared to $25.0 million in the fourth quarter of 2017.

 

   

Fanapt® net product sales were $20.6 million in the fourth quarter of 2018, a 7% increase compared to $19.2 million in the third quarter of 2018 and a 7% increase compared to $19.3 million in the fourth quarter of 2017.

 

   

Cash, cash equivalents and marketable securities (Cash) were $257.4 million as of December 31, 2018, representing an increase to Cash of $113.9 million during 2018.

Research and Development Highlights:

Tradipitant – Clinical Development

 

   

In December 2018, Vanda announced positive results from a Phase II clinical study (2301) of tradipitant in gastroparesis. Gastroparesis patients treated with tradipitant demonstrated significant improvement in nausea and most of the core gastroparesis symptoms.

 

   

Vanda expects to meet with the U.S. Food and Drug Administration (the FDA) to further define and confirm the path towards approval of tradipitant in the treatment of patients with gastroparesis, including the planned initiation of a Phase III clinical study in the second quarter of 2019.

 

   

Enrollment in the Phase III clinical study (EPIONE) of tradipitant in atopic dermatitis is ongoing. Results are expected in the first half of 2020. A second Phase III clinical study is expected to begin in the first quarter of 2020.

 

   

In January 2019, Vanda initiated a Phase II clinical study of tradipitant in motion sickness. Study results are expected in the second quarter of 2019.

 

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The following information was filed by Vanda Pharmaceuticals Inc. (VNDA) on Wednesday, February 13, 2019 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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