Please wait while we load the requested 10-Q report or click the link below:
Vanda Pharmaceuticals Reports First Quarter 2019 Financial Results
Total net product sales of $47.7 million in the first quarter of 2019, a 9% increase year over year
Vanda reiterates 2019 net product sales guidance of $215 million to $225 million
WASHINGTON May 1, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced financial and operational results for the first quarter ended March 31, 2019.
During the first quarter, Vanda made significant advances towards its commercial and research goals. Patients on treatment with Hetlioz continue to increase steadily, driven by broader awareness and recognition of Non-24. We are preparing for a possible launch later this year in jet lag disorder, an indication that has the potential to drive significant growth for our Hetlioz franchise. Tradipitant clinical development is advancing for three indications, atopic dermatitis, gastroparesis and motion sickness, said Mihael H. Polymeropoulos, M.D., Vandas President and CEO. We believe that Vanda is well positioned for significant growth in the coming quarters and years given its strong commercial and clinical development pipeline and its exceptional people.
Key Financial Highlights:
Total net product sales from HETLIOZ® and Fanapt® were $47.7 million in the first quarter of 2019, a 10% decrease compared to $53.0 million in the fourth quarter of 2018 and a 9% increase compared to $43.6 million in the first quarter of 2018.
HETLIOZ® net product sales were $29.0 million in the first quarter of 2019, an 11% decrease compared to $32.4 million in the fourth quarter of 2018 and a 14% increase compared to $25.4 million in the first quarter of 2018. In the first quarter of 2019, HETLIOZ® units sold to patients declined by 2% compared to the fourth quarter of 2018.
Fanapt® net product sales were $18.8 million in the first quarter of 2019, a 9% decrease compared to $20.6 million in the fourth quarter of 2018 and a 3% increase compared to $18.2 million in the first quarter of 2018. In the first quarter of 2019, Fanapt® prescriptions, as reported by IQVIA, declined by 5% compared to the fourth quarter of 2018.
Cash, cash equivalents and marketable securities (Cash) were $267.8 million as of March 31, 2019, representing an increase to Cash of $10.5 million and $19.0 million as compared to December 31, 2018 and March 31, 2018, respectively.
Key Research and Development Highlights:
Tradipitant Clinical Development
Vanda plans to meet with the U.S. Food and Drug Administration (the FDA) in the second quarter of 2019 to further define and confirm the path towards approval of tradipitant in the treatment of patients with gastroparesis.
Vanda plans to initiate a Phase III clinical study of tradipitant in gastroparesis 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 third quarter of 2019.
Page 1 of 8
The following information was filed by Vanda Pharmaceuticals Inc. (VNDA) on Wednesday, May 1, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
View differences made from one quarter to another to evaluate Vanda Pharmaceuticals Inc.'s financial trajectory
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were
removed , and by Vanda Pharmaceuticals Inc..