Full Press Release Details
WASHINGTON,May 6, 2026/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced financial and operational results for the first quarter ended March 31, 2026.
"Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform atnereus.us, and the FDA approval of BYSANTI," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation."
Financial Highlights
Key Commercial Highlights
Key Regulatory & Clinical Development Highlights
Corporate Highlight
GAAP Financial Results
Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025.
2026 Financial Guidance
Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™while maintaining prior ranges for Fanapt®and other products:
Conference Call
Vanda has scheduled a conference call for today, Wednesday, May 6, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8051722. A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 2026 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 8051722.
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 "2026 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of imsidolimab for the treatment of GPP, and the related timeline for approval; Vanda's expectations with respect to its continued growth and ability to create value; Vanda's clinical development plans and expected timelines for BYSANTITMfor the treatment of MDD, NEREUSTMin the prevention of vomiting induced byGLP-1therapies, and VQW-765 in the treatment of adults with social anxiety disorder; and Vanda's expectations with respect to the strength of its business 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 review of, and reach a decision with respect to, the BLA for imsidolimab by December 12, 2026; Vanda's ability to successfully execute the commercial launches of NEREUSTMfor the prevention of vomiting induced by motion and BYSANTI™ for the treatments of bipolar I disorder and schizophrenia; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the clinical study for BYSANTITMfor the treatment of MDD and receive results in in the first quarter of 2027; Vanda's ability to complete the Thetis study and receive results in 2026; and Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 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.
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
SOURCE Vanda Pharmaceuticals Inc.
| Full Year 2026Financial Objectives | Prior Full Year 2026Guidance | Revised Full Year 2026Guidance |
| Total revenues | $230 to $260 million | $240 to $290 million |
| Fanapt®net product sales | $150 to $170 million | $150 to $170 million |
| NEREUS™net product sales | Not provided | $10 to $30 million |
| Other net product sales | $80 to $90 million | $80 to $90 million |
| VANDA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except for share and per share amounts)(unaudited) | |||
| Three Months Ended | |||
| March 312026 | March 312025 | ||
| Revenues: | |||
| Fanapt®net product sales | $ 29,560 | $ 23,545 | |
| HETLIOZ®net product sales | 15,947 | 20,872 | |
| PONVORY®net product sales | 6,211 | 5,624 | |
| Total revenues | 51,718 | 50,041 | |
| Operating expenses: | |||
| Cost of goods sold excluding amortization | 3,159 | 3,521 | |
| Research and development | 28,435 | 35,712 | |
| Selling, general and administrative | 68,361 | 50,084 | |
| Intangible asset amortization | 1,987 | 1,752 | |
| Total operating expenses | 101,942 | 91,069 | |
| Loss from operations | (50,224) | (41,028) | |
| Other income, net | 1,800 | 3,660 | |
| Loss before income taxes | (48,424) | (37,368) | |
| Provision (benefit) for income taxes | 143 | (7,874) | |
| Net loss | $ (48,567) | $ (29,494) | |
| Net loss per share, basic | $ (0.82) | $ (0.50) | |
| Net loss per share, diluted | $ (0.82) | $ (0.50) | |
| Weighted average shares outstanding, basic | 59,459,982 | 58,527,775 | |
| Weighted average shares outstanding, diluted | 59,459,982 | 58,527,775 |
| VANDA PHARMACEUTICALS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited) | |||
| March 312026 | December 312025 | ||
| ASSETS | |||
| Current assets: | |||
| Cash and cash equivalents | $ 54,034 | $ 84,851 | |
| Marketable securities | 148,276 | 178,996 | |
| Accounts receivable, net | 56,879 | 54,578 | |
| Inventory | 1,699 | 1,852 | |
| Prepaid expenses and other current assets | 32,281 | 26,985 | |
| Total current assets | 293,169 | 347,262 | |
| Property and equipment, net | 2,245 | 2,248 | |
| Operating lease right-of-use assets | 4,536 | 3,923 | |
| Finance lease right-of-use assets | 7,284 | 7,343 | |
| Intangible assets, net | 115,102 | 117,089 | |
| Non-current inventory and other | 11,189 | 11,083 | |
| Total assets | $ 433,525 | $ 488,948 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||
| Current liabilities: | |||
| Accounts payable and accrued liabilities | $ 60,620 | $ 68,297 | |
| Product revenue allowances | 74,962 | 76,865 | |
| Total current liabilities | 135,582 | 145,162 | |
| Operating lease non-current liabilities | 3,266 | 2,991 | |
| Finance lease non-current liabilities | 3,785 | 4,076 | |
| Other non-current liabilities | 10,127 | 9,533 | |
| Total liabilities | 152,760 | 161,762 | |
| Stockholders' equity: | |||
| Common stock | 60 | 59 | |
| Additional paid-in capital | 723,826 | 721,264 | |
| Accumulated other comprehensive income | 212 | 629 | |
| Accumulated deficit | (443,333) | (394,766) | |
| Total stockholders' equity | 280,765 | 327,186 | |
| Total liabilities and stockholders' equity | $ 433,525 | $ 488,948 |