On May 6, 2020 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the first quarter ended March 31, 2020 (Press release, Vanda Pharmaceuticals, MAY 6, 2020, View Source [SID1234557176]).

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"Our strong financial performance in the first quarter well positions Vanda to continue to innovate and serve our patients, even during this deadly pandemic," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO.

Key Financial and Corporate Highlights

Total revenues from HETLIOZ and Fanapt were $58.0 million in the first quarter of 2020, a 22% increase compared to $47.7 million in the first quarter of 2019.
HETLIOZ net product sales were $35.3 million in the first quarter of 2020, a 22% increase compared to $29.0 million in the first quarter of 2019.
Fanapt net product sales were $22.7 million in the first quarter of 2020, a 21% increase compared to $18.8 million in the first quarter of 2019.
Cash, cash equivalents and marketable securities (Cash) were $312.3 million as of March 31, 2020, representing an increase to Cash of $44.5 million compared to March 31, 2019.
Net income was $0.5 million for the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019.
Key Product and Pipeline Highlights

Vanda is working proactively across its business and research units to protect employees and customers, and to maintain business continuity as a result of the COVID-19 pandemic.

Products

Vanda is encouraged by the strong performance of its commercial products during the first quarter of 2020, driving 22% year-over-year growth. Vanda is implementing marketing and sales strategies aimed at overcoming the disruptions caused by the pandemic. Vanda remains committed to continue innovating and bringing value to patients and prescribers, while advancing and strengthening the awareness and use of its products.

Pipeline

The COVID-19 pandemic has impacted clinical research globally, including Vanda’s previously reported clinical trials. New recruitment for the tradipitant atopic dermatitis, gastroparesis and motion sickness programs, as well as the HETLIOZ delayed sleep phase disorder study and Fanapt bipolar disorder and long acting injectable studies, is currently on hold.

Tradipitant

The ongoing atopic dermatitis and gastroparesis studies have been adapted in accordance with U.S. Food and Drug Administration (FDA) guidance to protect the health and safety of currently enrolled patients and healthcare providers.
The results of the recent atopic dermatitis (EPIONE), gastroparesis (VLY686-2301) and motion sickness (Motion Sifnos) studies have all been submitted to peer-review publications.
See below for details on Vanda’s clinical study, ODYSSEY VLY-686-3501, for the treatment of patients with COVID-19 Acute Respiratory Distress Syndrome (ARDS).
HETLIOZ (tasimelteon)

Discussions with the FDA are ongoing regarding the supplemental New Drug Applications for HETLIOZ in the treatments of jet lag disorder and Smith-Magenis Syndrome.
COVID-19 Therapeutic Program

Vanda initiated the following activities aimed at combating COVID-19:

Vanda announced the initiation of ODYSSEY VLY-686-3501, a Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant for the treatment of patients with COVID-19 ARDS. Results of this study are expected in the third quarter of 2020.
Vanda also announced the initiation of the CALYPSO genetics study to evaluate the role of human and viral genetic variations in COVID-19 infection and disease severity.
Vanda and the University of Illinois at Chicago (UIC) announced a research partnership to identify small molecule inhibitors of cathepsin-L, a host enzyme required for viral processing.
GAAP Financial Results

Net income was $0.5 million for the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019. Diluted net income per share was $0.01 in the first quarter of 2020, compared to a diluted net loss per share of $0.01 in the first quarter of 2019.

2020 Financial Guidance

Vanda will continue to assess the impact of the rapidly evolving COVID-19 pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance communicated by Vanda as of February 25, 2020 is shown below.

Conference Call

Vanda has scheduled a conference call for today, Wednesday, May 6, 2020, at 4:30 PM ET. During the call, Vanda’s management will discuss the first quarter 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 2583625. A replay of the call will be available on Wednesday, May 6, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, May 13, 2020 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 2583625.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.