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8-K
VANDA PHARMACEUTICALS INC. filed this Form 8-K on 11/07/2018
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EX-99.1

Exhibit 99.1

LOGO

Vanda Pharmaceuticals Reports Third Quarter 2018 Financial Results

 

   

Hetlioz® net product sales grew to $29.9 million in the third quarter of 2018, a 34% increase compared to the third quarter of 2017

   

Results from clinical studies of tradipitant in gastroparesis and HETLIOZ® in Smith-Magenis Syndrome are expected by the end of 2018

WASHINGTON – November 7, 2018 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2018.

Key Highlights:

 

   

Vanda reiterates 2018 net product sales guidance of $180 million to $200 million.

 

   

Total net product sales from HETLIOZ® and Fanapt® were $49.1 million during the third quarter of 2018, a 4% increase compared to $47.4 million in the second quarter of 2018 and a 19% increase compared to $41.3 million in the third quarter of 2017.

HETLIOZ® (tasimelteon)

 

   

HETLIOZ® net product sales were $29.9 million in the third quarter of 2018, a 7% increase compared to $28.0 million in the second quarter of 2018 and a 34% increase compared to $22.3 million in the third quarter of 2017.

Fanapt® (iloperidone)

 

   

Fanapt® net product sales were $19.2 million in the third quarter of 2018, a less than 1% decrease compared to $19.3 million in the second quarter of 2018 and a less than 1% increase compared to $19.1 million in the third quarter of 2017.

Research and Development

Tradipitant

 

   

Enrollment in the clinical study of tradipitant in gastroparesis is complete. Results are expected by the end of 2018.

   

The Phase III study (EPIONE) of tradipitant in atopic dermatitis is ongoing.

HETLIOZ® (tasimelteon)

 

   

Enrollment in the clinical study of HETLIOZ® in Smith-Magenis Syndrome is complete. Results are expected by the end of 2018.

   

Vanda submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for HETLIOZ® in jet lag disorder and expects a filing date by the end of 2018.

   

In September, a HETLIOZ® driving studying demonstrated no impairment of next day driving performance.

Fanapt® (iloperidone)

 

   

A pharmacokinetic study of the long acting injectable (Depot) formulation of Fanapt® enrolled its first patient during October 2018.

 

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