On February 10, 2021 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the fourth quarter and full year ended December 31, 2020 (Press release, Vanda Pharmaceuticals, FEB 10, 2021, View Source [SID1234574877]).
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"I am very proud of the significant accomplishments we realized during this challenging year," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "As we look forward to the new year, it is worth noting some of our significant accomplishments from 2020: Vanda achieved record commercial revenue despite extraordinary difficulty in the field, which we believe is a testament to the value our products bring to patients; HETLIOZ received FDA approval for nighttime sleep disturbances in patients with Smith-Magenis Syndrome; our tradipitant gastroparesis Phase III study continued recruitment; the FDA approved individual Expanded Access to tradipitant for multiple gastroparesis patients; we launched the tradipitant study for COVID-19 pneumonia; the FDA approved the Investigational New Drug application for VSJ-110 in allergic conjunctivitis; the United States Supreme Court affirmed the patent ruling on Fanapt; and our research and development efforts advanced the clinical programs for our commercial assets as well as those in our pipeline. We look forward to another great year of accomplishments, including further revenue growth, the commercial launch of HETLIOZ in patients with Smith-Magenis Syndrome, and the results of the tradipitant Phase III study in gastroparesis, to highlight a few."
Key Financial and Corporate Highlights
Fourth Quarter of 2020
Total net product sales from HETLIOZ and Fanapt were $67.7 million in the fourth quarter of 2020, an 11% increase compared to $60.9 million in the fourth quarter of 2019.
HETLIOZ net product sales were $44.2 million in the fourth quarter of 2020, a 14% increase compared to $38.6 million in the fourth quarter of 2019.
Fanapt net product sales were $23.5 million in the fourth quarter of 2020, a 5% increase compared to $22.3 million in the fourth quarter of 2019.
Income before taxes was $10.9 million in the fourth quarter of 2020 compared to $5.8 million in the fourth quarter of 2019.
Full Year 2020
Total net product sales from HETLIOZ and Fanapt were $248.2 million for the full year 2020, a 9% increase compared to $227.2 million for the full year 2019.
HETLIOZ net product sales were $160.7 million for the full year 2020, a 12% increase compared to $143.0 million for the full year 2019.
Fanapt net product sales were $87.5 million for the full year 2020, a 4% increase compared to $84.2 million for the full year 2019.
Income before taxes was $31.7 million for the full year 2020 compared to $29.0 million for the full year 2019.
Cash, cash equivalents and marketable securities (Cash) was $367.7 million as of December 31, 2020, representing an increase to Cash of $55.6 million compared to December 31, 2019.
Key Product and Pipeline Highlights
Products
Vanda is encouraged by the strength of its commercial performance during the fourth quarter of 2020. Vanda continues to implement marketing and sales strategies aimed at supporting growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the Fanapt for schizophrenia direct-to-consumer campaign, which was launched in 2020. Vanda is continuing its activities to support and facilitate the treatment of individuals in the U.S. living with Smith-Magenis Syndrome (SMS), and is committed to its awareness campaign and the support of patients suffering with Non-24-Hour Sleep-Wake Disorder.
Pipeline
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 first half of 2021, with a New Drug Application (NDA) filing projected in the second half of 2021.
The COVID-19 pneumonia Phase III clinical study (ODYSSEY VLY-686-3501) is ongoing.
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 SMS.1 HETLIOZ capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021. SMS is estimated to affect 1/15,000-25,000 births in the U.S.2 HETLIOZ is the first and only FDA approved medication for patients with SMS.
A Phase III clinical study for HETLIOZ in delayed sleep phase disorder (DSPD) is expected to be initiated in the first quarter of 2021.
A clinical development program for HETLIOZ in autism spectrum disorder (ASD) is expected to be initiated in the first quarter of 2021.
Fanapt (iloperidone)
Development of the long acting injectable (LAI) formulation of Fanapt is ongoing.
A clinical program for Fanapt in Parkinson’s disease psychosis (PDP) is expected to begin in the first quarter of 2021.
GAAP Financial Results
Income before taxes was $10.9 million in the fourth quarter of 2020 compared to $5.8 million in the fourth quarter of 2019. Net income was $8.2 million in the fourth quarter of 2020 compared to net income of $4.2 million in the fourth quarter of 2019. Diluted net income per share was $0.15 in the fourth quarter of 2020 compared to diluted net income per share of $0.08 in the fourth quarter of 2019.
Income before taxes was $31.7 million for the full year 2020 compared to $29.0 million for the full year 2019. Net income was $23.3 million for the full year 2020 compared to net income of $115.6 million for the full year 2019. The full year 2019 net income of $115.6 million and the 2019 income tax benefit of $86.5 million include the favorable impact of the release of Vanda’s deferred tax asset valuation allowance.
Diluted net income per share was $0.42 for the full year 2020 compared to diluted net income per share of $2.11 for the full year 2019.
2021 Financial Guidance
Vanda expects to achieve the following financial objectives in 2021:
Conference Call
Vanda has scheduled a conference call for today, Wednesday, February 10, 2021, at 4:30 PM ET. During the call, Vanda’s management will discuss the fourth quarter and full year 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 3557867. A replay of the call will be available on Wednesday, February 10, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, February 17, 2021 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 3557867.
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.