Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results

Rhea-AI Summary

Vanda Pharmaceuticals (Nasdaq: VNDA) reported fourth quarter and full year 2020 results, achieving record commercial revenue of $67.7 million in Q4, an 11% increase year-over-year. HETLIOZ® sales rose 14% to $44.2 million, while Fanapt® sales increased 5% to $23.5 million. Despite a drop in annual net income to $23.3 million from $115.6 million in 2019, Vanda holds $367.7 million in cash. Looking ahead, the company projects 2021 revenues between $270-$300 million, with HETLIOZ® and Fanapt® sales expected to reach $180-$200 million and $90-$100 million, respectively.

Positive

• Q4 2020 total net product sales of $67.7 million, an 11% increase YoY.
• HETLIOZ® sales increased 14% in Q4 2020 to $44.2 million.
• Fanapt® sales rose 5% in Q4 2020 to $23.5 million.
• Projected 2021 revenue guidance of $270-$300 million.
• Cash position of $367.7 million as of December 31, 2020.

Negative

• Net income for 2020 decreased to $23.3 million from $115.6 million in 2019.

WASHINGTON, Feb. 10, 2021 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2020.

"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:

Full Year 2021 Financial Objectives	Full Year 2021 Guidance
Total revenues	$270 to $300 million
HETLIOZ® net product sales	$180 to $200 million
Fanapt® net product sales	$90 to $100 million
Year-end 2021 Cash	Greater than $400 million

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.

References

1. Refer to Company press release titled "FDA Approves HETLIOZ^® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome" issued on December 1, 2020. https://vandapharmaceuticalsinc.gcs-web.com/node/14306/pdf
2. Orphanet ORPHA number 819.

About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, the guidance provided under "2021 Financial Guidance" above and statements regarding Vanda's revenue expectations for 2021, the commercial launch of HETLIOZ^® for the treatment of patients with SMS, Vanda's marketing and sales strategies, the expected availability of the HETLIOZ LQ^TM liquid formulation and the clinical development and regulatory timelines for tradipitant, HETLIOZ^® and Fanapt^®, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's assumptions regarding its ability to continue to grow its business in the U.S., the ability of Vanda's third-party manufacturer to timely provide Vanda with a supply of the HETLIOZ LQ^TM liquid formulation, and Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis and COVID-19 pneumonia, HETLIOZ^® in the treatment of DSPD and ASD, Fanapt^® LAI in the treatment of schizophrenia, and Fanapt^® in the treatment of PDP. Therefore, no assurance can be given that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except for share and per share amounts) (unaudited)
	Three Months Ended								Twelve Months Ended
	December 31 2020				December 31 2019				December 31 2020				December 31 2019
Revenues:
HETLIOZ® net product sales	$	44,171			$	38,599			$	160,686			$	142,980
Fanapt® net product sales	23,482				22,331				87,482				84,208
Total revenues	67,653				60,930				248,168				227,188
Operating expenses:
Cost of goods sold excluding amortization	6,412				6,225				23,364				24,488
Research and development	14,849				13,074				55,577				48,649
Selling, general and administrative	35,571				37,018				140,510				129,736
Intangible asset amortization	370				370				1,478				1,505
Total operating expenses	57,202				56,687				220,929				204,378
Income from operations	10,451				4,243				27,239				22,810
Other income	473				1,567				4,416				6,218
Income before income taxes	10,924				5,810				31,655				29,028
Provision (benefit) for income taxes	2,734				1,594				8,318				(86,525)
Net income	$	8,190			$	4,216			$	23,337			$	115,553
Net income per share, basic	$	0.15			$	0.08			$	0.43			$	2.17
Net income per share, diluted	$	0.15			$	0.08			$	0.42			$	2.11
Weighted average shares outstanding, basic	54,731,042				53,389,950				54,427,683				53,137,562
Weighted average shares outstanding, diluted	55,596,697				54,973,952				55,190,802				54,847,060

 

VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited)
	December 31 2020				December 31 2019
ASSETS
Current assets:
Cash and cash equivalents	$	61,031			$	45,072
Marketable securities	306,709				267,057
Accounts receivable, net	30,036				26,367
Inventory	1,280				1,140
Prepaid expenses and other current assets	10,089				14,500
Total current assets	409,145				354,136
Property and equipment, net	4,136				3,864
Operating lease right-of-use assets	10,459				11,180
Intangible assets, net	21,559				23,037
Deferred tax assets	81,516				87,680
Non-current inventory and other	6,641				3,851
Total assets	$	533,456			$	483,748
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities	$	31,509			$	27,590
Product revenue allowances	34,427				31,915
Total current liabilities	65,936				59,505
Operating lease non-current liabilities	11,497				12,455
Other non-current liabilities	2,757				843
Total liabilities	80,190				72,803
Stockholders' equity:
Common stock	55				54
Additional paid-in capital	650,300				631,307
Accumulated other comprehensive income	239				249
Accumulated deficit	(197,328)				(220,665)
Total stockholders' equity	453,266				410,945
Total liabilities and stockholders' equity	$	533,456			$	483,748

 

Corporate Contact:
AJ Jones II
Chief Corporate Affairs and Communications Officer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com 

Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com 

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

What were Vanda Pharmaceuticals' Q4 2020 earnings results?

Vanda reported Q4 2020 earnings with total net product sales of $67.7 million, a net income of $8.2 million, and diluted net income per share of $0.15.

What is Vanda Pharmaceuticals' financial guidance for 2021?

Vanda projects total revenues between $270 million and $300 million for 2021, with HETLIOZ® and Fanapt® sales expected to reach $180-$200 million and $90-$100 million, respectively.

How did Vanda Pharmaceuticals perform in full year 2020?

For the full year 2020, Vanda achieved total net product sales of $248.2 million, a 9% increase from 2019, but net income dropped to $23.3 million from $115.6 million.

What are the key accomplishments of Vanda Pharmaceuticals in 2020?

In 2020, Vanda launched HETLIOZ® for Smith-Magenis Syndrome, advanced its clinical programs, and maintained strong revenue growth despite challenges.