Vanda (NASDAQ: VNDA) grows Fanapt sales, wins new FDA approval

Q: How did Vanda Pharmaceuticals (VNDA) perform financially in 2025?

Vanda’s 2025 total revenues were $216.1 million , up 9% year over year, led by Fanapt. However, GAAP net loss widened to $220.5 million , mainly due to higher operating expenses and a large, one-time non-cash income tax charge related to deferred tax assets.

Q: What drove Fanapt sales growth for Vanda Pharmaceuticals (VNDA) in 2025?

Fanapt net product sales grew 24% to $117.3 million in 2025. Management attributed this to rising total prescriptions, strong new-to-brand prescription growth, and commercial initiatives including direct-to-consumer campaigns and expanded promotion in schizophrenia and bipolar I disorder.

Q: Why did Vanda Pharmaceuticals (VNDA) report a large 2025 net loss?

The 2025 GAAP net loss of $220.5 million reflects increased research, selling, and administrative expenses plus a one-time, non-cash income tax charge of $113.7 million from recording a valuation allowance against all deferred tax assets, significantly impacting reported earnings.

Q: What is Vanda Pharmaceuticals’ (VNDA) 2026 revenue guidance?

For 2026, Vanda expects total revenues of $230–$260 million from currently marketed products. Guidance includes $150–$170 million of Fanapt net product sales and $80–$90 million from other products such as HETLIOZ and PONVORY.

Q: Which recent FDA decisions affect Vanda Pharmaceuticals (VNDA)?

The FDA approved NEREUS (tradipitant) for preventing motion-induced vomiting, adding a new commercial product. In addition, the Bysanti NDA for bipolar I disorder and schizophrenia has a February 21, 2026 PDUFA date, and an imsidolimab BLA for GPP has been submitted.

Q: What is Vanda Pharmaceuticals’ (VNDA) cash position as of year-end 2025?

As of December 31, 2025 , Vanda held $263.8 million in cash, cash equivalents and marketable securities. This represents a decrease of $110.8 million compared to December 31, 2024, reflecting operating losses and ongoing investment in R&D and commercial activities.

Filing Impact

(High)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Vanda Pharmaceuticals reported full year 2025 total revenues of $216.1 million, up 9%, led by Fanapt net product sales of $117.3 million, a 24% increase. HETLIOZ and PONVORY sales declined modestly for the year.

GAAP net loss widened to $220.5 million from $18.9 million, driven largely by a one-time, non-cash income tax charge of $113.7 million related to a valuation allowance against deferred tax assets. Cash, cash equivalents and marketable securities were $263.8 million as of December 31, 2025.

Operationally, the FDA approved NEREUS (tradipitant) for prevention of motion-induced vomiting, while Bysanti (milsaperidone) has a PDUFA target action date of February 21, 2026 and an imsidolimab BLA for generalized pustular psoriasis was submitted. For 2026, Vanda projects total revenues of $230–$260 million, including Fanapt net product sales of $150–$170 million.

Positive

Fanapt growth and revenue outlook: Full year 2025 Fanapt net product sales rose 24% to $117.3 million, driving total revenues up 9% to $216.1 million, with 2026 guidance targeting $230–$260 million in total revenues and $150–$170 million from Fanapt.
Regulatory and pipeline milestones: The FDA approved NEREUS (tradipitant) for prevention of motion-induced vomiting, Bysanti (milsaperidone) has a February 21, 2026 PDUFA date, and an imsidolimab BLA for generalized pustular psoriasis was submitted, adding potential future growth drivers.

Negative

Significantly higher GAAP losses and valuation allowance: GAAP net loss increased to $220.5 million in 2025 from $18.9 million in 2024, including a one-time, non-cash $113.7 million income tax charge from recording a full valuation allowance against deferred tax assets, and cash declined to $263.8 million.

Insights

Strong Fanapt growth and new approval offset by much larger 2025 loss.

Vanda Pharmaceuticals grew 2025 revenues to $216.1 million, up 9%, with Fanapt net product sales rising 24% to $117.3 million. This reflects successful commercial execution, supported by higher prescriptions and expanded use in schizophrenia and bipolar I disorder.

At the same time, operating expenses climbed sharply, and a one-time, non-cash income tax charge of $113.7 million pushed GAAP net loss to $220.5 million versus $18.9 million in 2024. Excluding this charge, management’s Non-GAAP view shows a smaller, though still substantial, loss.

Pipeline and regulatory momentum are notable. The FDA approved NEREUS for motion-induced vomiting prevention, Bysanti has a February 21, 2026 PDUFA date, and an imsidolimab BLA was filed. For 2026, guidance of $230–$260 million in revenues, including $150–$170 million from Fanapt, frames expectations for continued but measured top-line growth.

02/11/2026 - 04:05 PM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 11, 2026

VANDA PHARMACEUTICALS INC.

(Exact name of Registrant as specified in its charter)

Delaware

001-34186

03-0491827

(State or other jurisdiction of incorporation)

(Commission File No.)

(IRS Employer Identification No.)

2200 Pennsylvania Avenue NW

Suite 300E

Washington, DC 20037

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (202) 734-3400


Not Applicable
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	VNDA	The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨


Item 2.02.						Results of Operations and Financial Condition.

On February 11, 2026, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release and is holding a conference call regarding its results of operations and financial condition for the quarter and full year ended December 31, 2025 (the “Earnings Call”). The full text of the press release, which includes information regarding Vanda’s use of Non-GAAP financial measures, is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Various statements to be made during the Earnings Call are “forward-looking statements” under the securities laws, including, but not limited to, statements regarding Vanda’s commercial products, plans and opportunities, as well as statements about Vanda’s products in development and the related clinical development and regulatory timelines and commercial potential for such products. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “project,” “target,” “goal,” “likely,” “will,” “would,” and “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. 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. and Vanda’s ability to complete the clinical development of, and obtain regulatory approval for, the products in its pipeline. Therefore, no assurance can be given that the actual 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 made during the Earnings Call 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 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. The information contained in this Current Report on Form 8-K is intended to be considered in the context of Vanda’s filings with the SEC and other public announcements that Vanda makes, by press release or otherwise, from time to time. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information conveyed on the Earnings Call will be provided only as of the date thereof, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements made during the Earnings Call after the date thereof, whether as a result of new information, future events or otherwise, except as required by law.

The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.


Item 9.01.						Financial Statements and Exhibits.

(d)Exhibits


Exhibit No.						Description

99.1						Press release of Vanda Pharmaceuticals Inc. dated February 11, 2026.

104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:

February 11, 2026

VANDA PHARMACEUTICALS INC.

By:

/s/ Timothy Williams

Name:

Timothy Williams

Title:

Senior Vice President, General Counsel and Secretary

Exhibit 99.1

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results

•Full year 2025 Fanapt® net product sales increased by 24% to $117.3 million compared to full year 2024

•Full year 2025 total revenues increased by 9% to $216.1 million compared to full year 2024

•NEREUSTM (tradipitant) approved for the prevention of vomiting induced by motion

•BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026

WASHINGTON – February 11, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2025.

“2025 showed strong momentum at Vanda, led by Fanapt, with net product sales up 24% to $117.3 million, driven by a 28% rise in total prescriptions and 149% surge in new-to-brand prescriptions - reflecting accelerating growth in schizophrenia and bipolar I disorder. We await the FDA decision on the Bysanti (milsaperidone) NDA by the February 21, 2026 PDUFA date, which would expand our psychiatry franchise in the global antipsychotic category. This category had a total addressable market estimated at approximately $20 billion in 2025,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board.

“The FDA approval of NEREUS (tradipitant) is a landmark - the first new oral therapy for motion-induced vomiting prevention in over 40 years - targeting a large addressable population of roughly 65–78 million U.S. adults experiencing symptoms, with tens of millions seeking relief annually. We are preparing for the NEREUS commercial launch and plan to start a Phase III program in the first half of 2026 for its use in preventing vomiting from GLP-1 analogs,” continued Dr. Polymeropoulos. “We submitted the imsidolimab BLA in Q4 2025 for generalized pustular psoriasis, a rare orphan condition. With our current franchise - Fanapt, HETLIOZ, HETLIOZ LQ, and PONVORY - we expect 2026 total revenues of $230 to $260 million from these marketed products alone, providing a solid baseline. We look forward to continued growth from this portfolio, with further contributions from the NEREUS launch and potential approvals of Bysanti and imsidolimab.”

Financial Highlights

Fourth Quarter of 2025

•Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $57.2 million in the fourth quarter of 2025, an 8% increase compared to $53.2 million in the fourth quarter of 2024.

•Fanapt® net product sales were $33.2 million in the fourth quarter of 2025, a 25% increase compared to $26.6 million in the fourth quarter of 2024.

•HETLIOZ® net product sales were $16.4 million in the fourth quarter of 2025, an 18% decrease compared to $20.0 million in the fourth quarter of 2024.

•PONVORY® net product sales were $7.6 million in the fourth quarter of 2025, a 17% increase compared to $6.5 million in the fourth quarter of 2024.

•Loss before income taxes was $38.0 million in the fourth quarter of 2025 compared to a loss before income taxes of $6.5 million in the fourth quarter of 2024.

•Provision for income taxes was $103.2 million in the fourth quarter of 2025 compared to a benefit for income taxes of $1.6 million in the fourth quarter of 2024. The provision for income taxes in the fourth quarter of 2025 includes the

impact of the recording of a valuation allowance of $113.7 million against all of Vanda’s deferred tax assets, which is a non-cash charge.

•Cash, cash equivalents and marketable securities (Cash) was $263.8 million as of December 31, 2025, representing a decrease to Cash of $29.9 million compared to September 30, 2025.

Full Year 2025

•Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $216.1 million for the full year 2025, a 9% increase compared to $198.8 million for the full year 2024.

•Fanapt® net product sales were $117.3 million for the full year 2025, a 24% increase compared to $94.3 million for the full year 2024.

•HETLIOZ® net product sales were $71.4 million for the full year 2025, a 7% decrease compared to $76.7 million for the full year 2024.

•PONVORY® net product sales were $27.4 million for the full year 2025, a 2% decrease compared to $27.8 million for the full year 2024.

•Loss before income taxes was $138.6 million for the full year 2025 compared to a loss before income taxes of $22.9 million for the full year 2024.

•Provision for income taxes was $81.8 million for the full year 2025 compared to a benefit for income taxes of $4.0 million for the full year 2024. The provision for income taxes for the full year 2025 includes the impact of the recording of a valuation allowance of $113.7 million against all of Vanda’s deferred tax assets, which is a non-cash charge.

•Cash was $263.8 million as of December 31, 2025, representing a decrease to Cash of $110.8 million compared to December 31, 2024.

Key Operational Highlights – Commercial

•Fanapt® experienced significant growth, with total prescriptions (TRx)1 increasing by 36% and Fanapt® net product sales increasing by 25% in the fourth quarter of 2025 as compared to the fourth quarter of 2024. Fanapt® total prescriptions increased by 28% and Fanapt® net product sales increased by 24% for the full year 2025 as compared to the full year 2024. New to brand prescriptions (NBRx)1 increased by 108% in the fourth quarter of 2025 as compared to the fourth quarter of 2024 and increased by 149% for the full year 2025 as compared to the full year 2024.

•During 2025, Vanda's direct-to-consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for the company and its products, Fanapt® and PONVORY®. The Company maintained strategic investments in its commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. Fanapt® performance remains the focus of Vanda’s commercial initiatives and encourages us to continue to invest in this differentiated medicine, and, if approved, the franchise-extending launch of Bysanti™.

Key Operational Highlights – Regulatory & Clinical Development

•The U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion.

•Bysanti™ (milsaperidone) New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026.

•A Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is enrolling patients and results are expected in 2026.

•Vanda announced positive results of a clinical study of NEREUSTM in the prevention of vomiting induced by a GLP-1 analog, Wegovy® (semaglutide). A Phase III clinical program is anticipated to be initiated in the first half of 2026.

•Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) was submitted to the FDA in the fourth quarter of 2025.

•A Phase III study of VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, in the treatment of adults with social anxiety disorder has been initiated and study results are expected by the end of 2026.

•The Phase III study of the long acting injectable (LAI) formulation of iloperidone in the treatment of schizophrenia in relapse-prevention is enrolling patients.

•A clinical study of the LAI formulation of iloperidone in people with treatment-resistant hypertension is ongoing and Vanda is enrolling patients.

•On January 8, 2026, Vanda announced that it had received a decision letter from the FDA Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in the current form. This letter followed CDER’s re-review of the jet lag sNDA under Vanda’s collaborative framework agreement with the FDA. Vanda has requested that the FDA Commissioner resume hearing proceedings.

GAAP Financial Results

Net loss was $141.2 million in the fourth quarter of 2025 compared to net loss of $4.9 million in the fourth quarter of 2024. Diluted net loss per share was $2.39 in the fourth quarter of 2025 compared to diluted net loss per share of $0.08 in the fourth quarter of 2024.

Net loss was $220.5 million for the full year 2025 compared to net loss of $18.9 million for the full year 2024. Diluted net loss per share was $3.74 for the full year 2025 compared to diluted net loss per share of $0.33 for the full year 2024.

Provision for Income Taxes - One-Time, Non-Cash Charge Impact

In the fourth quarter of 2025, Vanda determined that it is not more-likely-than-not that it will realize its existing net deferred tax assets, having reviewed both positive and negative evidence as well as expectations of future taxable income, and recorded a valuation allowance against all its deferred tax assets. As a result, the fourth quarter of 2025 provision for income taxes includes a one-time, non-cash income tax charge of $113.7 million. Excluding this one-time non-cash tax charge, our full year 2025:

•Effective tax rate would have increased to 23%, compared to the reported effective tax rate of negative 59%.

•Net loss would have decreased to $106.8 million, compared to the reported net loss of $220.5 million.

•Diluted net loss per share would have decreased to $1.81, compared to the reported diluted net loss per share of $3.74.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled “Non-GAAP Financial Information” and “Reconciliation of GAAP to Non-GAAP Financial Information.”

2026 Financial Guidance

Due to the recent and upcoming regulatory and commercial milestones, Vanda’s 2026 financial guidance is limited to revenue guidance for currently commercialized products which includes Fanapt®, HETLIOZ® and PONVORY®. Vanda expects to achieve the following financial objectives in 2026.


Full Year 2026 Financial Objectives			Full Year 2026 Guidance
Total revenues			$230 to $260 million
Fanapt® net product sales			$150 to $170 million
Other net product sales			$80 to $90 million

Conference Call

Vanda has scheduled a conference call for today, Wednesday, February 11, 2026, at 4:30 PM ET. During the call, Vanda’s management will discuss the fourth quarter and full year 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, February 11, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, February 18, 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 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

1.IQVIA Prescription Data

Non-GAAP Financial Information

Vanda believes that the above Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. The Non-GAAP effective tax rate, Non-GAAP net loss and Non-GAAP dilutive EPS exclude the one-time, non-cash valuation allowance income tax charge. Vanda believes that excluding the impact of this one-time, non-cash charge better reflects the recurring economic characteristics of its business, as well as Vanda's use of financial resources and its long-term performance.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies because all companies may not calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda's financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial information in connection with its GAAP financial information. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.

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 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 BysantiTM for the treatments of bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines and prospects for approval; Vanda’s commercial launch plans for NEREUSTM for the prevention of vomiting induced by motion; the prevalence of motion-induced vomiting in the U.S. and the number of people seeking relief each year; the goals, focus and expected results of Vanda’s commercial infrastructure investment strategy; Vanda’s clinical development plans and expected timelines for BysantiTM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by Wegovy®, the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension and VQW-765 in the treatment of adults with social anxiety disorder; Vanda’s plans to continue its pursuit of FDA approval of HETLIOZ® for the treatment of jet lag 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 reviews of, and reach decisions with respect to, the NDA for BysantiTM by February 21, 2026; Vanda’s ability to obtain regulatory approval of imsidolimab for the treatment of GPP; Vanda’s ability to successfully execute the commercial launch of NEREUSTM; the accuracy of the estimates of the prevalence of motion-induced vomiting in the U.S. and the number of people seeking relief each year; 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 study for BysantiTM for the treatment of MDD and receive results in 2026; Vanda’s ability to initiate the clinical program for NEREUSTM in the prevention of vomiting induced by Wegovy® in the first half of 2026; Vanda’s ability to complete enrollment of patients in the clinical studies for the LAI formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension;

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; and the FDA’s willingness to resume hearing proceedings on HETLIOZ® for the treatment of jet lag disorder. 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 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				Twelve Months Ended
	December 31 2025		December 31 2024		December 31 2025		December 31 2024
Revenues:
Fanapt® net product sales	$	33,218	$	26,649	$	117,302	$	94,297
HETLIOZ® net product sales	16,389		20,044		71,431		76,675
PONVORY® net product sales	7,609		6,492		27,372		27,800
Total revenues	57,216		53,185		216,105		198,772
Operating expenses:
Cost of goods sold excluding amortization	3,833		2,590		13,044		11,314
Research and development	29,006		19,840		109,271		74,431
Selling, general and administrative	62,978		39,282		237,951		146,414
Intangible asset amortization	1,752		1,752		7,007		7,273
Total operating expenses	97,569		63,464		367,273		239,432
Loss from operations	(40,353)		(10,279)		(151,168)		(40,660)
Other income, net	2,351		3,782		12,521		17,739
Loss before income taxes	(38,002)		(6,497)		(138,647)		(22,921)
Provision (benefit) for income taxes	103,185		(1,585)		81,827		(4,021)
Net loss	$	(141,187)	$	(4,912)	$	(220,474)	$	(18,900)
Net loss per share, basic	$	(2.39)	$	(0.08)	$	(3.74)	$	(0.33)
Net loss per share, diluted	$	(2.39)	$	(0.08)	$	(3.74)	$	(0.33)
Weighted average shares outstanding, basic	59,098,957		58,308,487		58,930,157		58,149,087
Weighted average shares outstanding, diluted	59,098,957		58,308,487		58,930,157		58,149,087

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)


	December 31 2025		December 31 2024
ASSETS
Current assets:
Cash and cash equivalents	$	84,851	$	102,316
Marketable securities	178,996		272,327
Accounts receivable, net	54,578		47,101
Inventory	1,852		1,726
Prepaid expenses and other current assets	26,985		15,420
Total current assets	347,262		438,890
Property and equipment, net	2,248		2,132
Operating lease right-of-use assets	3,923		5,602
Finance lease right-of-use assets	7,343		4,943
Intangible assets, net	117,089		114,096
Deferred tax assets	—		81,440
Non-current inventory and other	11,083		9,101
Total assets	$	488,948	$	656,204
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities	$	68,297	$	39,086
Product revenue allowances	76,865		60,895

Total current liabilities	145,162		99,981
Operating lease non-current liabilities	2,991		4,944
Finance lease non-current liabilities	4,076		3,146
Other non-current liabilities	9,533		9,587
Total liabilities	161,762		117,658
Stockholders’ equity:
Common stock	59		58
Additional paid-in capital	721,264		712,706
Accumulated other comprehensive income	629		74
Accumulated deficit	(394,766)		(174,292)
Total stockholders’ equity	327,186		538,546
Total liabilities and stockholders’ equity	$	488,948	$	656,204

VANDA PHARMACEUTICALS INC.

Reconciliation of GAAP to Non-GAAP Financial Information

(in thousands, except for share and per share amounts)

(unaudited)


	Twelve Months Ended
		December 31 2025
Net loss		$	(220,474)
Adjustments:
One-time, non-cash income tax charge		113,699
Non-GAAP net loss		(106,775)
Net loss per share, basic		$	(1.81)
Net loss per share, diluted		$	(1.81)
Weighted average shares outstanding, basic		58,930,157
Weighted average shares outstanding, diluted		58,930,157

Effective tax rate		(59)		%
Adjustments:
Effect of one-time, non-cash income tax charge		82%
Non-GAAP effective tax rate		23%

Corporate Contact:

Kevin Moran

Senior Vice President, Chief Financial Officer and Treasurer

Vanda Pharmaceuticals Inc.

202-734-3400

pr@vandapharma.com

Jim Golden / Jack Kelleher / Dan Moore

Collected Strategies

VANDA-CS@collectedstrategies.com

Source: View Original Filing on SEC EDGAR

FAQ

How did Vanda Pharmaceuticals (VNDA) perform financially in 2025?

Vanda’s 2025 total revenues were $216.1 million, up 9% year over year, led by Fanapt. However, GAAP net loss widened to $220.5 million, mainly due to higher operating expenses and a large, one-time non-cash income tax charge related to deferred tax assets.

What drove Fanapt sales growth for Vanda Pharmaceuticals (VNDA) in 2025?

Fanapt net product sales grew 24% to $117.3 million in 2025. Management attributed this to rising total prescriptions, strong new-to-brand prescription growth, and commercial initiatives including direct-to-consumer campaigns and expanded promotion in schizophrenia and bipolar I disorder.

Why did Vanda Pharmaceuticals (VNDA) report a large 2025 net loss?

The 2025 GAAP net loss of $220.5 million reflects increased research, selling, and administrative expenses plus a one-time, non-cash income tax charge of $113.7 million from recording a valuation allowance against all deferred tax assets, significantly impacting reported earnings.

What is Vanda Pharmaceuticals’ (VNDA) 2026 revenue guidance?

For 2026, Vanda expects total revenues of $230–$260 million from currently marketed products. Guidance includes $150–$170 million of Fanapt net product sales and $80–$90 million from other products such as HETLIOZ and PONVORY.

Which recent FDA decisions affect Vanda Pharmaceuticals (VNDA)?

The FDA approved NEREUS (tradipitant) for preventing motion-induced vomiting, adding a new commercial product. In addition, the Bysanti NDA for bipolar I disorder and schizophrenia has a February 21, 2026 PDUFA date, and an imsidolimab BLA for GPP has been submitted.

What is Vanda Pharmaceuticals’ (VNDA) cash position as of year-end 2025?

As of December 31, 2025, Vanda held $263.8 million in cash, cash equivalents and marketable securities. This represents a decrease of $110.8 million compared to December 31, 2024, reflecting operating losses and ongoing investment in R&D and commercial activities.

Filing Exhibits & Attachments

4 documents

Press Releases

EX-99.1 EX-99.1 147.1 KB

Vanda (NASDAQ: VNDA) grows Fanapt sales, wins new FDA approval