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Vanda Pharmaceuticals Reports First Quarter 2021 Financial Results

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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 LQ 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.

Fanapt® (iloperidone)

  • A Phase III clinical study of Fanapt® in bipolar disorder resumed during the first quarter of 2021 after pausing in 2020 due to the COVID-19 pandemic.
  • Development of the long acting injectable (LAI) formulation of Fanapt® is ongoing.
  • A clinical development program of Fanapt® in Parkinson's disease psychosis (PDP) was initiated in the first quarter of 2021.

GAAP Financial Results

Income before taxes was $10.4 million in the first quarter of 2021 compared to $1.2 million in the first quarter of 2020. Net income was $8.7 million in the first quarter of 2021 compared to net income of $0.5 million in the first quarter of 2020. Diluted net income per share was $0.15 in the first quarter of 2021 compared to diluted net income per share of $0.01 in the first quarter of 2020.

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, May 5, 2021, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2021 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5709209. A replay of the call will be available on Wednesday, May 5, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, May 12, 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 5709209.

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

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 the clinical development and regulatory timelines for tradipitant 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. and Vanda's ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis. Therefore, no assurance can be given that the 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. 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, 2020, 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


March 31
2021


March 31
2020

Revenues:




HETLIOZ® net product sales

$

39,343



$

35,336


Fanapt® net product sales

23,326



22,664


Total revenues

62,669



58,000


Operating expenses:




Cost of goods sold excluding amortization

6,030



5,207


Research and development

16,131



15,527


Selling, general and administrative

29,797



37,021


Intangible asset amortization

370



370


Total operating expenses

52,328



58,125


Income (loss) from operations

10,341



(125)


Other income

87



1,366


Income before income taxes

10,428



1,241


Provision for income taxes

1,778



755


Net income

$

8,650



$

486


Net income per share, basic

$

0.16



$

0.01


Net income per share, diluted

$

0.15



$

0.01


Weighted average shares outstanding, basic

55,145,789



53,806,317


Weighted average shares outstanding, diluted

56,505,087



54,870,146


 

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)



March 31
2021


December 31
2020

ASSETS




Current assets:




Cash and cash equivalents

$

72,132



$

61,031


Marketable securities

306,030



306,709


Accounts receivable, net

31,474



30,036


Inventory

1,361



1,280


Prepaid expenses and other current assets

10,227



10,089


Total current assets

421,224



409,145


Property and equipment, net

3,840



4,136


Operating lease right-of-use assets

10,194



10,459


Intangible assets, net

21,189



21,559


Deferred tax assets

80,355



81,516


Non-current inventory and other

6,389



6,641


Total assets

$

543,191



$

533,456


LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable and accrued liabilities

$

26,105



$

31,509


Product revenue allowances

35,679



34,427


Total current liabilities

61,784



65,936


Operating lease non-current liabilities

11,125



11,497


Other non-current liabilities

2,655



2,757


Total liabilities

75,564



80,190


Stockholders' equity:




Common stock

56



55


Additional paid-in capital

656,057



650,300


Accumulated other comprehensive income

192



239


Accumulated deficit

(188,678)



(197,328)


Total stockholders' equity

467,627



453,266


Total liabilities and stockholders' equity

$

543,191



$

533,456


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 

Cision View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-first-quarter-2021-financial-results-301284901.html

SOURCE Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc.

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About VNDA

vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.