PR Newswire | May 5, 2021 04:02PM EDT

05/05 15:01 CDT

Vanda Pharmaceuticals Reports First Quarter 2021 Financial Results- Q1 2021 total revenues were $62.7 million, an 8% increase compared to Q1 2020- The Phase III clinical study of tradipitant in gastroparesis is expected to complete enrollment in the second quarter of 2021- A Phase III clinical study for HETLIOZ(r) in delayed sleep phase disorder (DSPD) was initiated in the first quarter of 2021 WASHINGTON, May 5, 2021

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(r) 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(r) in delayed sleep phase disorder."

Financial Highlights

* Total net product sales from HETLIOZ(r) and Fanapt(r) 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(r) 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(r) 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(r) (tasimelteon)

* In December 2020, the U.S. Food and Drug Administration (FDA) approved HETLIOZ(r) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances in Smith-Magenis Syndrome (SMS).1 HETLIOZ(r) capsules, for adults with SMS, were immediately available after approval and the HETLIOZ LQ(tm) liquid formulation, for children with SMS, became available in the first quarter of 2021. * A Phase III clinical study of HETLIOZ(r) in delayed sleep phase disorder (DSPD) was initiated in the first quarter of 2021.

Fanapt(r) (iloperidone)

* A Phase III clinical study of Fanapt(r) 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(r) is ongoing. * A clinical development program of Fanapt(r) 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 Full Year 2021

Financial Objectives Guidance

Total revenues $270 to $300 million

HETLIOZ^(r) net product sales $180 to $200 million

Fanapt^(r) 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

* Refer to Company press release titled "FDA Approves HETLIOZ(r) (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 STATEMENTSVarious 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 March 31 2021 2020

Revenues:

HETLIOZ^(r) net product sales $39,343 $35,336

Fanapt^(r) 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 55,145,78953,806,317

Weighted average shares outstanding, diluted56,505,08754,870,146

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)



March 31 December 31 2021 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 EveryHead of Corporate Affairs Vanda Pharmaceuticals Inc. 202-734-3400 pr@vandapharma.com

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SOURCE Vanda Pharmaceuticals Inc.