Form 8-K

8-K — Vanda Pharmaceuticals Inc.

Accession: 0001628280-26-031241

Filed: 2026-05-06

Period: 2026-05-06

CIK: 0001347178

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — vnda-20260506.htm (Primary)

EX-99.1 (vnda8-k562026exhibit991.htm)

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8-K (Primary)

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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): May 6, 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 May 6, 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 ended March 31, 2026 (the “Earnings Call”). The full text of the press release 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 May 6, 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: May 6, 2026 VANDA PHARMACEUTICALS INC.

By: /s/ Kevin Moran

Name: Kevin Moran

Title: Senior Vice President, Chief Financial Officer and Treasurer

EX-99.1

Filename: vnda8-k562026exhibit991.htm · Sequence: 2

Document

Exhibit 99.1

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

•Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76%

•NEREUSTM (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery

•Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUSTM

•BYSANTITM (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026

•Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026

WASHINGTON – May 6, 2026 – 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 at nereus.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

•Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025.

•Fanapt® net product sales were $29.6 million, up 26% year-over-year.

•HETLIOZ® net product sales were $15.9 million, down 24% year-over-year.

•PONVORY® net product sales were $6.2 million, up 10% year-over-year.

•Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement.

•Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant).

Key Commercial Highlights

•Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026.

•NEREUSTM is now commercially available nationwide through nereus.us, Vanda’s innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUSTM represents a breakthrough in both science and patient access.

Key Regulatory & Clinical Development Highlights

•BYSANTITM (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTITM is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044.

•Vanda’s ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including:

◦The Phase III study of BYSANTITM as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027.

◦The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026.

◦The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected by the end of 2026.

•The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2.

Corporate Highlight

•On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent.

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:

Full Year 2026

Financial Objectives

Prior Full Year 2026

Guidance

Revised Full Year 2026

Guidance

Total revenues $230 to $260 million $240 to $290 million

Fanapt® net product sales

$150 to $170 million $150 to $170 million

NEREUSTM net product sales

Not provided $10 to $30 million

Other net product sales $80 to $90 million $80 to $90 million

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

1.IQVIA Prescription Data

2.Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026).

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 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 BYSANTITM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, 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 NEREUSTM for 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 BYSANTITM for 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 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

March 31

2026 March 31

2025

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 31

2026 December 31

2025

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

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

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Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration