Full Press Release Details
WASHINGTON,Oct. 29, 2025/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced financial and operational results for the third quarter ended September 30, 2025.
"This quarter reflects strong commercial execution, with total net product sales reaching $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions. HETLIOZ continues to deliver stable performance with $18.0 million in Q3 sales," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We are particularly encouraged by our advancing pipeline, with multiple near-term regulatory milestones: the tradipitant NDA for motion sickness under FDA review with a PDUFA target action date of December 30, 2025; the Bysanti NDA for bipolar I disorder and schizophrenia also under FDA review with a PDUFA target action date of February 21, 2026; and the anticipated Q4 submission of the imsidolimab BLA for generalized pustular psoriasis. We are also investing strategically in our commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. We believe that these milestones, combined with our collaborative framework with the FDA, will position Vanda for sustained growth and expanded therapeutic impact in 2026 and beyond."
Financial Highlights
Third Quarter of 2025
First Nine Months of 2025
Key Operational Highlights – Commercial
Key Operational Highlights – Regulatory & Clinical Development
GAAP Financial Results
Net loss was $22.6 million in the third quarter of 2025 compared to net loss of $5.3 million in the third quarter of 2024. Diluted net loss per share was $0.38 in the third quarter of 2025 compared to diluted net loss per share of $0.09 in the third quarter of 2024.
Net loss was $79.3 million in the first nine months of 2025 compared to net loss of $14.0 million in the first nine months of 2024. Diluted net loss per share was $1.35 in the first nine months of 2025 compared to diluted net loss per share of $0.24 in the first nine months of 2024.
2025 Financial Guidance
Vanda is updating its 2025 financial guidance and expects to achieve the following financial objectives in 2025:
Full Year 2025
Financial Objectives
Prior Full Year 2025
Guidance
Revised Full Year 2025
Guidance
Conference Call
Vanda has scheduled a conference call for today, Wednesday, October 29, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2025 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8728050. A replay of the call will be available on Wednesday, October 29, 2025, beginning at 7:00 PM ET and will be accessible until Wednesday, November 5, 2025 at 11:59 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 8728050.
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
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 visitwww.vandapharma.comand follow us on X @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of BysantiTM for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines and prospects for approval; the goals and expected results of Vanda's commercial infrastructure investment strategy; Vanda's expectations with respect to the strength of its business; Vanda's clinical development plans and expected timelines for tradipitant in the prevention of vomiting induced by Wegovy®, BysantiTM for the treatment of MDD and the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension; and the actions that the FDA is expected to take, and the timing thereof, with respect to the NDA for tradipitant for the treatment of motion sickness and the sNDA for HETLIOZ®for the treatment of jet lag disorder 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 ability to continue to grow its business; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in the fourth quarter of 2025; Vanda's ability to achieve long-term market leadership and execute new commercial launches through its commercial infrastructure investments; Vanda's ability to complete the clinical studies for tradipitant in the prevention of vomiting induced by Wegovy®and BysantiTM for the treatment of MDD and receive results in the expected timeframes; Vanda's ability to complete enrollment of patients in the clinical study for the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention and to begin enrolling patients in the study of the long acting injectable formulation of iloperidone for the treatment of hypertension in the expected timeframe; and the FDA's ability to conduct expedited re-reviews of the partial clinical hold on tradipitant for the treatment of motion sickness by November 26, 2025 and the sNDA for HETLIOZ®for the treatment of jet lag disorder by January 7, 2026. 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 most recent Annual Report on Form 10-K, 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 atwww.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)
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
Corporate Contact:Kevin MoranSenior Vice President, Chief Financial Officer and TreasurerVanda Pharmaceuticals Inc.202-734-3400[email protected]
Jim Golden / Jack Kelleher / Dan MooreCollected Strategies[email protected]
Follow us on X @vandapharma
| Full Year 2025Financial Objectives | Prior Full Year 2025Guidance | Revised Full Year 2025Guidance |
| Total revenues | $210 to $250 million | $210 to $230 million |
| Year-end 2025 Cash | $280 to $320 million | $260 to $290 million |
| 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 302025 | September 302024 | September 302025 | September 302024 | ||||
| Revenues: | |||||||
| Fanapt®net product sales | $ 31,245 | $ 23,919 | $ 84,084 | $ 67,648 | |||
| HETLIOZ®net product sales | 17,978 | 17,870 | 55,042 | 56,631 | |||
| PONVORY®net product sales | 7,035 | 5,862 | 19,763 | 21,308 | |||
| Total revenues | 56,258 | 47,651 | 158,889 | 145,587 | |||
| Operating expenses: | |||||||
| Cost of goods sold excluding amortization | 2,954 | 2,551 | 9,211 | 8,724 | |||
| Research and development | 22,563 | 16,776 | 80,265 | 54,591 | |||
| Selling, general and administrative | 60,273 | 37,573 | 174,973 | 107,132 | |||
| Intangible asset amortization | 1,752 | 1,751 | 5,255 | 5,521 | |||
| Total operating expenses | 87,542 | 58,651 | 269,704 | 175,968 | |||
| Loss from operations | (31,284) | (11,000) | (110,815) | (30,381) | |||
| Other income, net | 2,894 | 4,756 | 10,170 | 13,957 | |||
| Loss before income taxes | (28,390) | (6,244) | (100,645) | (16,424) | |||
| Benefit for income taxes | (5,804) | (920) | (21,358) | (2,436) | |||
| Net loss | $ (22,586) | $ (5,324) | $ (79,287) | $ (13,988) | |||
| Net loss per share, basic | $ (0.38) | $ (0.09) | $ (1.35) | $ (0.24) | |||
| Net loss per share, diluted | $ (0.38) | $ (0.09) | $ (1.35) | $ (0.24) | |||
| Weighted average shares outstanding, basic | 59,091,478 | 58,261,961 | 58,873,268 | 58,095,566 | |||
| Weighted average shares outstanding, diluted | 59,091,478 | 58,261,961 | 58,873,268 | 58,095,566 |
| VANDA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited) | |||
| September 302025 | December 312024 | ||
| ASSETS | |||
| Current assets: | |||
| Cash and cash equivalents | $ 70,022 | $ 102,316 | |
| Marketable securities | 223,730 | 272,327 | |
| Accounts receivable, net | 50,541 | 47,101 | |
| Inventory | 2,042 | 1,726 | |
| Prepaid expenses and other current assets | 21,161 | 15,420 | |
| Total current assets | 367,496 | 438,890 | |
| Property and equipment, net | 2,460 | 2,132 | |
| Operating lease right-of-use assets | 4,368 | 5,602 | |
| Finance lease right-of-use assets | 5,071 | 4,943 | |
| Intangible assets, net | 108,841 | 114,096 | |
| Deferred tax assets | 103,073 | 81,440 | |
| Non-current inventory and other | 9,831 | 9,101 | |
| Total assets | $ 601,140 | $ 656,204 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||
| Current liabilities: | |||
| Accounts payable and accrued liabilities | $ 47,619 | $ 39,086 | |
| Product revenue allowances | 70,251 | 60,895 | |
| Total current liabilities | 117,870 | 99,981 | |
| Operating lease non-current liabilities | 3,419 | 4,944 | |
| Finance lease non-current liabilities | 2,808 | 3,146 | |
| Other non-current liabilities | 11,044 | 9,587 | |
| Total liabilities | 135,141 | 117,658 | |
| Stockholders' equity: | |||
| Common stock | 59 | 58 | |
| Additional paid-in capital | 718,979 | 712,706 | |
| Accumulated other comprehensive income | 540 | 74 | |
| Accumulated deficit | (253,579) | (174,292) | |
| Total stockholders' equity | 465,999 | 538,546 | |
| Total liabilities and stockholders' equity | $ 601,140 | $ 656,204 |