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WASHINGTON, Nov. 2, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2022.
"We continue to focus on strong commercial execution, the advancement of our clinical pipeline and our upcoming regulatory milestones of the submissions of an NDA for tradipitant in gastroparesis and an sNDA for HETLIOZ® in insomnia," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "With stable, mature revenue, efficient operations and strong cash on hand, we are well positioned to deliver long-term growth."
Financial Highlights
Third Quarter of 2022
First Nine Months of 2022
Key Operational Highlights
HETLIOZ® (tasimelteon)
Tradipitant
Fanapt® (iloperidone)
Early-Stage Programs
Legal and Regulatory Updates
GAAP Financial Results
Net income was $3.3 million in the third quarter of 2022 compared to net income of $7.8 million in the third quarter of 2021. Diluted net income per share was $0.06 in the third quarter of 2022 compared to diluted net income per share of $0.14 in the third quarter of 2021.
Net loss was $0.6 million in the first nine months of 2022 compared to net income of $26.1 million in the first nine months of 2021. Diluted net loss per share was $0.01 in the first nine months of 2022 compared to diluted net income per share of $0.46 in the first nine months of 2021.
2022 Financial Guidance
Vanda is updating its 2022 financial guidance and expects to achieve the following financial objectives in 2022:
Full Year 2022 Financial Objectives | Revised Full Year 2022 Guidance | Prior Full Year 2022 Guidance | |
Total revenues | $240 to $270 million | $240 to $280 million | |
HETLIOZ® net product sales | $150 to $170 million | $150 to $180 million | |
Fanapt® net product sales | $90 to $100 million | $90 to $100 million | |
Year-end 2022 Cash | Greater than $450 million | Greater than $440 million |
Conference Call
Vanda has scheduled a conference call for today, Wednesday, November 2, 2022, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2022 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 5456289. A replay of the call will be available on Wednesday, November 2, 2022, beginning at 8:30 PM ET and will be accessible until Wednesday, November 9, 2022 at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 5456289.
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.
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 "2022 Financial Guidance" above and statements regarding Vanda's plans for pursuit of regulatory approval of HETLIOZ® in the treatment of insomnia and Jet Lag Disorder, and tradipitant in the short-term treatment of nausea in gastroparesis and in the treatment of motion sickness, the research and development activities of the strategic partnership between Vanda and OliPass and the potential therapeutic opportunities that may result from it, Vanda's clinical development and regulatory plans and strategies for VPO-227, the timing of the court's decision with respect to the Company's HETLIOZ® patent litigation, and the clinical development timelines for tradipitant, Fanapt® and VQW-765 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 the strength of its business in the U.S., Vanda's ability to complete and submit the NDA and sNDA for tradipitant and HETLIOZ®, respectively, in the fourth quarter of 2022 and the first half of 2023, respectively, the FDA's assessment of the sufficiency of the data packages to be included in Vanda's planned NDA and sNDA submissions for tradipitant and HETLIOZ®, respectively, Vanda's ability to complete the Phase III clinical study of tradipitant in the treatment of motion sickness by mid-2023, Vanda's ability to complete the Phase III clinical study of Fanapt® in bipolar I disorder in the fourth quarter of 2022, Vanda's ability to complete the Phase II clinical study of VQW-765 in social/performance anxiety in the fourth quarter of 2022, Vanda's ability to progress the two ASO targets it has identified, and Vanda's ability to complete the IND for VPO-227 and submit it to the FDA in 2023. 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, 2021, 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 | Nine Months Ended | |||||||
September 30 | September 30 | September 30 | September 30 | |||||
Revenues: | ||||||||
HETLIOZ® net product sales | $ 41,335 | $ 45,615 | $ 119,554 | $ 129,467 | ||||
Fanapt® net product sales | 23,983 | 24,480 | 70,346 | 71,196 | ||||
Total revenues | 65,318 | 70,095 | 189,900 | 200,663 | ||||
Operating expenses: | ||||||||
Cost of goods sold excluding amortization | 6,320 | 6,797 | 18,044 | 19,393 | ||||
Research and development | 24,857 | 19,653 | 67,316 | 56,032 | ||||
Selling, general and administrative | 29,854 | 32,456 | 103,703 | 90,600 | ||||
Intangible asset amortization | 379 | 370 | 1,137 | 1,109 | ||||
Total operating expenses | 61,410 | 59,276 | 190,200 | 167,134 | ||||
Income (loss) from operations | 3,908 | 10,819 | (300) | 33,529 | ||||
Other income (expense) | 1,553 | (97) | 1,987 | 225 | ||||
Income before income taxes | 5,461 | 10,722 | 1,687 | 33,754 | ||||
Provision for income taxes | 2,191 | 2,951 | 2,273 | 7,680 | ||||
Net income (loss) | $ 3,270 | $ 7,771 | $ (586) | $ 26,074 | ||||
Net income (loss) per share, basic | $ 0.06 | $ 0.14 | $ (0.01) | $ 0.47 | ||||
Net income (loss) per share, diluted | $ 0.06 | $ 0.14 | $ (0.01) | $ 0.46 | ||||
Weighted average shares outstanding, basic | 56,574,503 | 55,668,156 | 56,397,805 | 55,467,528 | ||||
Weighted average shares outstanding, diluted | 56,969,033 | 57,040,736 | 56,397,805 | 56,818,295 | ||||
VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) | |||
September 30 | December 31 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 49,397 | $ 52,071 | |
Marketable securities | 405,394 | 380,742 | |
Accounts receivable, net | 29,352 | 32,467 | |
Inventory | 1,590 | 1,025 | |
Prepaid expenses and other current assets | 21,373 | 11,996 | |
Total current assets | 507,106 | 478,301 | |
Property and equipment, net | 2,594 | 3,113 | |
Operating lease right-of-use assets | 8,262 | 9,272 | |
Intangible assets, net | 18,944 | 20,081 | |
Deferred tax assets | 74,529 | 74,878 | |
Non-current inventory and other | 10,353 | 8,147 | |
Total assets | $ 621,788 | $ 593,792 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 50,125 | $ 34,438 | |
Product revenue allowances | 42,498 | 39,981 | |
Total current liabilities | 92,623 | 74,419 | |
Operating lease non-current liabilities | 8,903 | 10,055 | |
Other non-current liabilities | 4,605 | 4,390 | |
Total liabilities | 106,131 | 88,864 | |
Stockholders' equity: | |||
Common stock | 57 | 56 | |
Additional paid-in capital | 681,847 | 669,223 | |
Accumulated other comprehensive loss | (1,485) | (175) | |
Accumulated deficit | (164,762) | (164,176) | |
Total stockholders' equity | 515,657 | 504,928 | |
Total liabilities and stockholders' equity | $ 621,788 | $ 593,792 |
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
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.