Vanda Pharmaceuticals Inc. (VNDA) 10-Q Quarterly Report May 2021

WASHINGTON – May 5, 2021 /PRNewswire/ – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2021.

“Despite seasonal and global challenges, we recorded another quarter of strong revenue across our commercial portfolio coupled with the launch of HETLIOZ® in the new indication of nighttime sleep disturbances in patients with Smith-Magenis Syndrome,” said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. “In our clinical programs, we have made significant progress, reaching 85% randomization in our Phase III tradipitant study in gastroparesis and initiating a new clinical program for HETLIOZ® in delayed sleep phase disorder.”

Financial Highlights

•Total net product sales from HETLIOZ® and Fanapt® were $62.7 million in the first quarter of 2021, an 8% increase compared to $58.0 million in the first quarter of 2020.

•HETLIOZ® net product sales were $39.3 million in the first quarter of 2021, an 11% increase compared to $35.3 million in the first quarter of 2020.

•Fanapt® net product sales were $23.3 million in the first quarter of 2021, a 3% increase compared to $22.7 million in the first quarter of 2020.

•Income before taxes was $10.4 million in the first quarter of 2021 compared to $1.2 million in the first quarter of 2020.

•Cash, cash equivalents and marketable securities (Cash) was $378.2 million as of March 31, 2021, representing an increase to Cash of $65.8 million compared to March 31, 2020.

Key Operational Highlights

Tradipitant

•The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study has a target enrollment of 200 randomized patients and is expected to complete enrollment in the second quarter of 2021, with a New Drug Application (NDA) filing expected in late 2021 or early 2022.

HETLIOZ® (tasimelteon)

•In December 2020, the U.S. Food and Drug Administration (FDA) approved HETLIOZ® capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).1 HETLIOZ® capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQTM liquid formulation, for children with SMS, became available in the first quarter of 2021.

•A Phase III clinical study of HETLIOZ® in delayed sleep phase disorder (DSPD) was initiated in the first quarter of 2021.

The following information was filed by Vanda Pharmaceuticals Inc. (VNDA) on Wednesday, May 5, 2021 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.

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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Vanda Pharmaceuticals Inc. provided additional information to their SEC Filing as exhibits

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: VNDA
CIK: 1347178
Form Type: 10-Q Quarterly Report
Accession Number: 0001347178-21-000015
Submitted to the SEC: Thu May 06 2021 7:01:47 AM EST
Accepted by the SEC: Thu May 06 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations

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Vanda Pharmaceuticals Inc. (VNDA) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

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