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0001347178FALSE00013471782025-07-312025-07-31

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): July 31, 2025
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 July 31, 2025, 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 June 30, 2025 (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  
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: July 31, 2025   VANDA PHARMACEUTICALS INC.
  By: /s/ Timothy Williams
  Name: Timothy Williams
  Title: Senior Vice President, General Counsel and Secretary

EX-99.1 2 vnda8-k7312025exhibit991.htm EX-99.1 Document

Exhibit 99.1
 vandaq32019earningsca_imaga.jpg
Vanda Pharmaceuticals Reports Second Quarter 2025 Financial Results
 
•Fanapt® Q2 2025 net product sales increased by 27% to $29.3 million compared to Q2 2024

•BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026
•Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025
•Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025
WASHINGTON – July 31, 2025 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2025.
“We have witnessed accelerated growth of Fanapt revenue coinciding with the expansion of our sales efforts alongside a broad direct to consumer brand awareness campaign and we expect this trend to continue in the coming quarters,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “Significant regulatory and clinical milestones are expected in the coming months which have the potential to strengthen our commercial portfolio and advance our deep clinical pipeline.”
Financial Highlights
Second Quarter of 2025
•Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $52.6 million in the second quarter of 2025, a 4% increase compared to $50.5 million in the second quarter of 2024.
•Fanapt® net product sales were $29.3 million in the second quarter of 2025, a 27% increase compared to $23.2 million in the second quarter of 2024.
•HETLIOZ® net product sales were $16.2 million in the second quarter of 2025, a 13% decrease compared to $18.7 million in the second quarter of 2024.
•PONVORY® net product sales were $7.1 million in the second quarter of 2025, an 18% decrease compared to $8.6 million in the second quarter of 2024.
•Net loss was $27.2 million in the second quarter of 2025 compared to net loss of $4.5 million in the second quarter of 2024.
•Cash, cash equivalents and marketable securities (Cash) was $325.6 million as of June 30, 2025, representing a decrease to Cash of $15.4 million compared to March 31, 2025.
First Six Months of 2025
•Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $102.6 million in the first six months of 2025, a 5% increase compared to $97.9 million in the first six months of 2024.
•Fanapt® net product sales were $52.8 million in the first six months of 2025, a 21% increase compared to $43.7 million in the first six months of 2024.
•HETLIOZ® net product sales were $37.1 million in the first six months of 2025, a 4% decrease compared to $38.8 million in the first six months of 2024.


•PONVORY® net product sales were $12.7 million in the first six months of 2025, an 18% decrease compared to $15.4 million in the first six months of 2024.
•Net loss was $56.7 million in the first six months of 2025 compared to net loss of $8.7 million in the first six months of 2024.
•Cash was $325.6 million as of June 30, 2025, representing a decrease to Cash of $49.1 million compared to December 31, 2024.
Key Operational Highlights – Commercial
•Fanapt® experienced significant growth with total prescriptions (TRx)1 increasing by approximately 24% and Fanapt® net product sales increasing by 27% in the second quarter of 2025 as compared to the second quarter of 2024.
•A direct to consumer campaign that started in the first quarter of 2025 continued in the second quarter of 2025, elevating brand awareness of the company and the key products Fanapt® and PONVORY®.
Key Operational Highlights – Regulatory & Clinical Development
•Bysanti™ New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026.
•Tradipitant NDA for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025.
•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.
•Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025.
GAAP Financial Results
Net loss was $27.2 million in the second quarter of 2025 compared to net loss of $4.5 million in the second quarter of 2024. Diluted net loss per share was $0.46 in the second quarter of 2025 compared to diluted net loss per share of $0.08 in the second quarter of 2024.
Net loss was $56.7 million in the first six months of 2025 compared to net loss of $8.7 million in the first six months of 2024. Diluted net loss per share was $0.96 in the first six months of 2025 compared to diluted net loss per share of $0.15 in the first six months of 2024.
2025 Financial Guidance
Vanda is reiterating its 2025 financial guidance and expects to achieve the following financial objectives in 2025:

Full Year 2025
Financial Objectives
Full Year 2025
Guidance
Total revenues $210 to $250 million
Year-end 2025 Cash
 $280 to $320 million
HHS Request for Information and Vanda Response
On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued a Request for Information (RFI) entitled “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again.” On July 14, 2025, Vanda submitted a public response to the RFI. Vanda’s response proposed (1) that FDA repeal unlawful regulations that delay and overburden the drug approval process, and (2) that FDA repeal its 1990s-era guidance mandating lethal animal testing. The original RFI is available on the Federal Register website, under document number 2025-08384. Our full response with exhibits is available under the documents section of the Vanda website and on regulations.gov, under comment ID AHRQ-2025-0001-0962.


Conference Call
Vanda has scheduled a conference call for today, Thursday, July 31, 2025, at 8:00 AM ET. During the call, Vanda’s management will discuss the second quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9430387. A replay of the call will be available on Thursday, July 31, 2025, beginning at 11:00 AM ET and will be accessible until Thursday, August 7, 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 9430387.
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
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 “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; Vanda’s near-term revenue expectations for Fanapt®; the potential commercial availability of Bysanti™ and tradipitant; and Vanda’s clinical development plans and expected timelines for BysantiTM for the treatment of MDD; 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 2025; Vanda’s ability to increase market awareness of Fanapt® for the acute treatment of bipolar I disorder and continue to drive Fanapt® revenue growth; Vanda’s ability to obtain FDA approval of Bysanti™ and tradipitant and successfully execute their commercial launches; and Vanda’s ability to complete the Phase III clinical study for BysantiTM for MDD and receive results in 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 Six Months Ended
  June 30
2025		 June 30
2024		 June 30
2025		 June 30
2024
Revenues:
Fanapt® net product sales
 $ 29,294  $ 23,150  $ 52,839  $ 43,729 
HETLIOZ® net product sales
 16,192  18,708  37,064  38,761 
PONVORY® net product sales
 7,104  8,616  12,728  15,446 
Total revenues 52,590  50,474  102,631  97,936 
Operating expenses:
Cost of goods sold excluding amortization 2,736  2,733  6,257  6,173 
Research and development 21,990  16,661  57,702  37,815 
Selling, general and administrative 64,616  39,474  114,700  69,559 
Intangible asset amortization 1,751  1,752  3,503  3,770 
Total operating expenses 91,093  60,620  182,162  117,317 
Loss from operations (38,503) (10,146) (79,531) (19,381)
Other income, net 3,616  4,630  7,276  9,201 
Loss before income taxes (34,887) (5,516) (72,255) (10,180)
Benefit for income taxes (7,680) (998) (15,554) (1,516)
Net loss
 $ (27,207) $ (4,518) $ (56,701) $ (8,664)

Net loss per share, basic		 $ (0.46) $ (0.08) $ (0.96) $ (0.15)
Net loss per share, diluted $ (0.46) $ (0.08) $ (0.96) $ (0.15)

Weighted average shares outstanding, basic		 58,993,990  58,220,838  58,762,358  57,990,890 
Weighted average shares outstanding, diluted 58,993,990  58,220,838  58,762,358  57,990,890 


VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
 
June 30
2025		 December 31
2024
ASSETS
Current assets:
Cash and cash equivalents $ 80,983  $ 102,316 
Marketable securities 244,567  272,327 
Accounts receivable, net 44,993  47,101 
Inventory 2,169  1,726 
Prepaid expenses and other current assets 22,209  15,420 
Total current assets 394,921  438,890 
Property and equipment, net 2,420  2,132 
Operating lease right-of-use assets 4,804  5,602 
Finance lease right-of-use assets 5,244  4,943 
Intangible assets, net 110,593  114,096 
Deferred tax assets 97,143  81,440 
Non-current inventory and other 9,621  9,101 
Total assets $ 624,746  $ 656,204 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 57,119  $ 39,086 
Product revenue allowances 64,370  60,895 
Total current liabilities 121,489  99,981 
Operating lease non-current liabilities 3,877  4,944 
Finance lease non-current liabilities 3,083  3,146 
Other non-current liabilities 9,968  9,587 
Total liabilities 138,417  117,658 
Stockholders’ equity:
Common stock 59  58 
Additional paid-in capital 716,867  712,706 
Accumulated other comprehensive income 396  74 
Accumulated deficit (230,993) (174,292)
Total stockholders’ equity 486,329  538,546 
Total liabilities and stockholders’ equity $ 624,746  $ 656,204 



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

Follow us on X @vandapharma
SOURCE Vanda Pharmaceuticals Inc.