| | WASHINGTON, July 28, 2021 /PRNewswire/ -- Vanda Pharmaceuticals, Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2021. “Vanda had another outstanding quarter of commercial revenue growth as we resumed activity across a number of our clinical programs. Our tradipitant in gastroparesis program is nearing completion, bringing us closer to a much-needed new treatment option for patients with gastroparesis and a potentially transformational commercial opportunity for Vanda,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. Financial Highlights Second Quarter of 2021 - Total net product sales from HETLIOZ® and Fanapt® were $67.9 million in the second quarter of 2021, a 9% increase compared to $62.2 million in the second quarter of 2020.
- HETLIOZ® net product sales were $44.5 million in the second quarter of 2021, a 7% increase compared to $41.6 million in the second quarter of 2020.
- Fanapt® net product sales were $23.4 million in the second quarter of 2021, a 13% increase compared to $20.6 million in the second quarter of 2020.
- Income before taxes was $12.6 million in the second quarter of 2021 compared to $11.1 million in the second quarter of 2020.
First Six Months of 2021 - Total net product sales from HETLIOZ® and Fanapt® were $130.6 million in the first six months of 2021, a 9% increase compared to $120.2 million in the first six months of 2020.
- HETLIOZ® net product sales were $83.9 million in the first six months of 2021, a 9% increase compared to $76.9 million in the first six months of 2020.
- Fanapt® net product sales were $46.7 million in the first six months of 2021, an 8% increase compared to $43.3 million in the first six months of 2020.
- Income before taxes was $23.0 million in the first six months of 2021 compared to $12.3 million in the first six months of 2020.
- Cash, cash equivalents and marketable securities (Cash) was $396.5 million as of June 30, 2021, representing an increase to Cash of $56.6 million compared to June 30, 2020.
Key Operational Highlights Tradipitant - The Phase III clinical study of tradipitant in gastroparesis is nearing completion with 95% of the target 200 patients already enrolled. Results are expected by the end of 2021.
HETLIOZ® (tasimelteon) - A Phase III clinical study of HETLIOZ® in delayed sleep phase disorder (DSPD) is currently enrolling patients.
Fanapt® (iloperidone) - A Phase III clinical study of Fanapt® in bipolar disorder is currently enrolling patients.
- A clinical pharmacology study of the long acting injectable (LAI) formulation of Fanapt® is ongoing.
Key Publications - The article “Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension” was published in July 2021 in Genetics in Medicine.1
GAAP Financial Results Income before taxes was $12.6 million in the second quarter of 2021 compared to $11.1 million in the second quarter of 2020. Net income was $9.7 million in the second quarter of 2021 compared to net income of $8.7 million in the second quarter of 2020. Diluted net income per share was $0.17 in the second quarter of 2021 compared to diluted net income per share of $0.16 in the second quarter of 2020. Income before taxes was $23.0 million in the first six months of 2021 compared to $12.3 million in the first six months of 2020. Net income was $18.3 million in the first six months of 2021 compared to net income of $9.2 million in the first six months of 2020. Diluted net income per share was $0.32 in the first six months of 2021 compared to diluted net income per share of $0.17 in the first six months 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, July 28, 2021, at 4:30 PM ET. During the call, Vanda’s management will discuss the second 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 5298904. A replay of the call will be available on Wednesday, July 28, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, August 4, 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 5298904. 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 - Polymeropoulos, C.M., Brooks, J., Czeisler, E.L., Fisher, M.A., Gibson, M.M., Kite, K., Smieszek, S.P., Xiao, C., Elsea, S.H., Birznieks, G., Polymeropoulos, M.H. (2021). Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension. Genetics in Medicine. https://doi.org/10.1038/s41436-021-01282-y
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 and commercial potential 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., Vanda’s ability to complete the clinical development and obtain regulatory approval for tradipitant in the treatment of gastroparesis, the prevalence of gastroparesis and Vanda’s ability to successfully commercialize tradipitant. 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 | | Six Months Ended | | | June 30
2021 | | June 30
2020 | | June 30
2021 | | June 30
2020 | | Revenues: | | | | | | | | | HETLIOZ® net product sales | $ | 44,509 | | | $ | 41,561 | | | $ | 83,852 | | | $ | 76,897 | | | Fanapt® net product sales | 23,390 | | | 20,646 | | | 46,716 | | | 43,310 | | | Total revenues | 67,899 | | | 62,207 | | | 130,568 | | | 120,207 | | | Operating expenses: | | | | | | | | | Cost of goods sold excluding amortization | 6,566 | | | 5,847 | | | 12,596 | | | 11,054 | | | Research and development | 20,248 | | | 12,903 | | | 36,379 | | | 28,430 | | | Selling, general and administrative | 28,347 | | | 33,917 | | | 58,144 | | | 70,938 | | | Intangible asset amortization | 369 | | | 369 | | | 739 | | | 739 | | | Total operating expenses | 55,530 | | | 53,036 | | | 107,858 | | | 111,161 | | | Income from operations | 12,369 | | | 9,171 | | | 22,710 | | | 9,046 | | | Other income | 235 | | | 1,918 | | | 322 | | | 3,284 | | | Income before income taxes | 12,604 | | | 11,089 | | | 23,032 | | | 12,330 | | | Provision for income taxes | 2,951 | | | 2,375 | | | 4,729 | | | 3,130 | | | Net income | $ | 9,653 | | | $ | 8,714 | | | $ | 18,303 | | | $ | 9,200 | | | Net income per share, basic | $ | 0.17 | | | $ | 0.16 | | | $ | 0.33 | | | $ | 0.17 | | | Net income per share, diluted | $ | 0.17 | | | $ | 0.16 | | | $ | 0.32 | | | $ | 0.17 | | | Weighted average shares outstanding, basic | 55,582,916 | | | 54,501,308 | | | 55,365,558 | | | 54,153,812 | | | Weighted average shares outstanding, diluted | 56,903,340 | | | 55,081,397 | | | 56,705,419 | | | 54,975,771 | | | VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited) | | | | | June 30
2021 | | December 31
2020 | | ASSETS | | | | | Current assets: | | | | | Cash and cash equivalents | $ | 57,242 | | | $ | 61,031 | | | Marketable securities | 339,251 | | | 306,709 | | | Accounts receivable, net | 37,090 | | | 30,036 | | | Inventory | 1,055 | | | 1,280 | | | Prepaid expenses and other current assets | 12,014 | | | 10,089 | | | Total current assets | 446,652 | | | 409,145 | | | Property and equipment, net | 3,631 | | | 4,136 | | | Operating lease right-of-use assets | 9,898 | | | 10,459 | | | Intangible assets, net | 20,820 | | | 21,559 | | | Deferred tax assets | 78,641 | | | 81,516 | | | Non-current inventory and other | 8,003 | | | 6,641 | | | Total assets | $ | 567,645 | | | $ | 533,456 | | | LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | Current liabilities: | | | | | Accounts payable and accrued liabilities | $ | 31,788 | | | $ | 31,509 | | | Product revenue allowances | 40,201 | | | 34,427 | | | Total current liabilities | 71,989 | | | 65,936 | | | Operating lease non-current liabilities | 10,740 | | | 11,497 | | | Other non-current liabilities | 3,696 | | | 2,757 | | | Total liabilities | 86,425 | | | 80,190 | | | Stockholders’ equity: | | | | | Common stock | 56 | | | 55 | | | Additional paid-in capital | 660,086 | | | 650,300 | | | Accumulated other comprehensive income | 103 | | | 239 | | | Accumulated deficit | (179,025) | | | (197,328) | | | Total stockholders’ equity | 481,220 | | | 453,266 | | | Total liabilities and stockholders’ equity | $ | 567,645 | | | $ | 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
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SOURCE Vanda Pharmaceuticals Inc. | |
