On February 25, 2020 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the fourth quarter and full year ended December 31, 2019 (Press release, Vanda Pharmaceuticals, FEB 25, 2020, View Source [SID1234554762]).

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"We had another year of outstanding commercial growth," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "I have never been more excited about the opportunities ahead with our relentless focus on developing innovative therapies for patients in need."

Key Financial Highlights

Total revenues were $60.9 million in the fourth quarter of 2019, a 15% increase compared to $53.0 million in the fourth quarter of 2018. Total revenues were $227.2 million for the full year 2019, an 18% increase compared $193.1 million for the full year 2018.
HETLIOZ net product sales were $38.6 million in the fourth quarter of 2019, a 19% increase compared to $32.4 million in the fourth quarter of 2018. HETLIOZ net product sales were $143.0 million for the full year 2019, a 23% increase compared to $115.8 million for the full year 2018.
Fanapt net product sales were $22.3 million in the fourth quarter of 2019, an 8% increase compared to $20.6 million in the fourth quarter of 2018. Fanapt net product sales were $84.2 million for the full year 2019, a 9% increase compared to $77.3 million for the full year 2018.
Cash, cash equivalents and marketable securities (Cash) were $312.1 million as of December 31, 2019, representing an increase to Cash of $54.8 million compared to December 31, 2018.
Key Product and Pipeline Highlights

Tradipitant

Results from the EPIONE study of tradipitant in the treatment of pruritus in atopic dermatitis were reported today. Vanda will reassess EPIONE 2 and determine next steps.
Enrollment in the Phase III study of tradipitant in gastroparesis (VP-VLY-686-3301) is ongoing.
Vanda expects to complete the Phase III program of tradipitant in motion sickness and file a New Drug Application with the U.S. Food and Drug Administration (FDA) in 2020.
Vanda continues to engage with the FDA over the requirement of a 9-month dog toxicity study.
HETLIOZ (tasimelteon)

Vanda submitted a supplemental New Drug Application (sNDA) for HETLIOZ in Smith-Magenis Syndrome (SMS), including data for a liquid formulation, and expects regulatory action by the FDA in 2020.
Vanda continues to pursue approval for HETLIOZ in the treatment of jet lag disorder (JLD).
A clinical program for HETLIOZ in delayed sleep phase disorder (DSPD) is ongoing.
Fanapt (iloperidone)

A Phase III study of Fanapt in bipolar disorder is ongoing.
Development of the long acting injectable (LAI) formulation of Fanapt is ongoing.
GAAP Financial Results

Net income was $4.2 million for the fourth quarter of 2019, compared to net income of $10.4 million for the fourth quarter of 2018. Diluted net income per share was $0.08 in the fourth quarter of 2019, compared to $0.19 in the fourth quarter of 2018.

Net income was $115.6 million for the full year 2019, compared to net income of $25.2 million, for the full year 2018. Diluted net income per share was $2.11 for the full year 2019, compared to $0.48 for the full year 2018. The income tax benefit of $86.5 million reflected in the financial results for the full year 2019 includes the favorable impact of the release of Vanda’s deferred tax asset valuation allowance.

2020 Financial Guidance

Vanda expects to achieve the following financial objectives in 2020:

Full Year 2020

Financial Objectives

Full Year 2020

Guidance

Total revenues

$240 to $260 million

HETLIOZ net product sales

$155 to $165 million

Fanapt net product sales

$85 to $95 million

Year-end 2020 Cash

Greater than $320 million

Conference Call

Vanda has scheduled a conference call for today, Tuesday, February 25, 2020, at 4:30 PM ET. During the call, Vanda’s management will discuss the fourth quarter and full year 2019 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 2149683. A replay of the call will be available on Tuesday, February 25, 2020, beginning at 7:30 PM ET and will be accessible until Tuesday, March 3, 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 2149683.

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.