Vanda Pharmaceuticals Q3 revenue rises 24% to $69.8M
Full-year 2026 revenue guidance is greater than $240 million, while the Quimilza BLA is under FDA review with a December 12, 2026 target action date.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Vanda Pharmaceuticals Inc. reported third-quarter 2026 revenue of $69.8 million, up 24% from $56.3 million in Q3 2025 and 38% from $50.5 million in Q2 2026. Operating expenses were $93.3 million, up 7% year over year but down 18% from Q2. Net loss was $22.6 million, compared with $22.6 million in Q3 2025 and $62.5 million in Q2; nine-month net loss was $133.6 million versus $79.3 million in 2025.
Product sales included Fanapt at $38.8 million, HETLIOZ at $21.7 million, PONVORY at $7.7 million and NEREUS at $1.6 million. Cash, cash equivalents and marketable securities totaled $140.5 million as of September 30, 2026, down $29.5 million during Q3. Vanda expects full-year 2026 revenue of greater than $240 million.
Vanda reported positive Phase III results for NEREUS in preventing GLP-1-associated vomiting and plans to discuss the data with the FDA and submit an sNDA. HETLIOZ had positive topline Phase III results for Delayed Sleep-Wake Phase Disorder; Vanda plans FDA discussions and an sNDA. Quimilza’s BLA for GPP is under FDA review, with a December 12, 2026 PDUFA target action date. BYSANTI’s launch is expected in Q4 2026.
2 points · 0 major1 major · 1 point
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointQ3 revenue increased 24% year over year to $69.8 million.
- Moderate pointNine-month product sales increased 8% to $172.1 million.
Negative
- Major pointNine-month net loss was $133.6 million, versus $79.3 million in 2025.
Filing Explained
At September 30, cash, equivalents and marketable securities were $123.4 million below year-end; HETLIOZ Q3 sales included about $7 million tied to June shipments.
Vanda’s
Vanda reported HETLIOZ sales up
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Q3 total revenue: $69.8 million
Q3 operating expenses: $93.3 million
Q3 net loss: $22.6 million
+3 more
6 metrics
Q3 total revenue
$69.8 million
Q3 2026; up 24% from $56.3 million in Q3 2025 and 38% from $50.5 million in Q2 2026
Q3 operating expenses
$93.3 million
Q3 2026; up 7% year over year and down 18% from Q2 2026
Q3 net loss
$22.6 million
Q3 2026; compared with $22.6 million in Q3 2025 and $62.5 million in Q2 2026
Nine-month net loss
$133.6 million
First nine months of 2026, compared with $79.3 million in the first nine months of 2025
Cash, cash equivalents and marketable securities
$140.5 million
As of September 30, 2026; decreased by $29.5 million in Q3 2026
Full-year revenue guidance
Greater than $240 million
Expected for full year 2026
Key Terms
Biologics License Application (BLA), PDUFA target action date, supplemental New Drug Application (sNDA), Delayed Sleep-Wake Phase Disorder (DSWPD), +1 more
5 terms
Biologics License Application (BLA) regulatory
"The Biologics License Application (BLA) for Quimilza™"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
PDUFA target action date regulatory
"with a Prescription Drug User Fee Act (PDUFA) target action date"
The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.
supplemental New Drug Application (sNDA) regulatory
"submit a supplemental New Drug Application (sNDA)"
A supplemental new drug application (snda) is a formal request made to regulatory authorities to make changes to an already approved medication, such as adding new uses, adjusting dosages, or improving manufacturing processes. It’s similar to updating a product’s packaging or instructions after it has been approved for sale. For investors, an snda signals ongoing development or improvements that could impact a company’s future sales or regulatory approval prospects.
Delayed Sleep-Wake Phase Disorder (DSWPD) medical
"adults with Delayed Sleep-Wake Phase Disorder (DSWPD)"
Montgomery-Asberg Depression Rating Scale (MADRS) medical
"Montgomery-Asberg Depression Rating Scale (MADRS)"
Earnings Snapshot
Total revenue: $69.8 million · Guidance included
Third quarter 2026
Total revenue
$69.8 million
Up 24% from $56.3 million in Q3 2025 and 38% from $50.5 million in Q2 2026
Operating expenses
$93.3 million
Up 7% year over year and down 18% from Q2 2026
Net loss
$22.6 million
Compared with $22.6 million in Q3 2025 and $62.5 million in Q2 2026
Guidance
Vanda expects total revenue for full year 2026 of greater than $240 million.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How far along is VNDA’s BYSANTI Phase III study enrollment?
The study had enrolled 55% of its 500-patient enrollment target. It was enrolling patients at 54 sites in the U.S. and Europe, with results expected in the first half of 2027.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): October 28, 2026
(Exact name of Registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File No.) | (IRS Employer Identification No.) | ||||||||||||
(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 | ||||||
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 October 28, 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 September 30, 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 October 28, 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: | October 28, 2026 | VANDA PHARMACEUTICALS INC. | |||||||||||||||
| By: | /s/ Daniel McGuire | ||||||||||||||||
| Name: | Daniel McGuire | ||||||||||||||||
| Title: | Senior Vice President, General Counsel and Secretary | ||||||||||||||||
Exhibit 99.1
Vanda Pharmaceuticals Reports Third Quarter 2026 Financial Results
•Q3 2026 Total Revenues increased 24% to $69.8 million compared to Q3 2025 and 38% compared to Q2 2026
•Q3 2026 Total Operating Expenses decreased by 18% to $93.3 million compared to Q2 2026
•Announced positive results from the Phase III study of NEREUS™ for prevention of GLP-1-induced vomiting
•NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026
•BYSANTITM commercial launch expected in Q4 2026
•QuimilzaTM BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026
WASHINGTON – October 28, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the third quarter ended September 30, 2026.
“We are pleased with the strong revenue growth in the third quarter, increasing 24% year-over-year, driven by continued Fanapt momentum and the early contribution from our NEREUS commercial launch, while operating expenses decreased 18% compared to the second quarter as key Phase III and launch-preparation activities conclude,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “Looking ahead, with the commercial launch of BYSANTI expected in the fourth quarter, the Quimilza BLA under FDA review with a December PDUFA date, and positive Phase III results supporting potential expansions for NEREUS in GLP-1-induced vomiting and HETLIOZ in Delayed Sleep-Wake Phase Disorder, we are focused on further moderating costs and driving revenue growth from our current portfolio and planned launches to support sustainable long-term value.”
Financial Highlights
Operating Expenses
•During 2025 and 2026, Vanda has advanced multiple Phase III programs, continued its commercial activities for Fanapt® (iloperidone), HETLIOZ® (tasimelteon) and PONVORY® (ponesimod) and prepared for the commercial launches, including manufacturing commercial supplies, of NEREUSTM (tradipitant), BYSANTITM (milsaperidone), and QuimilzaTM (imsidolimab). These activities resulted in significantly increased operating expenses in 2025 and 2026. As certain of these activities began concluding in Q3 2026, operating expenses have decreased and Vanda expects operating expenses to decrease further in future quarters, as the remainder of these activities conclude.
Third Quarter of 2026
•Total net product sales were $69.8 million in Q3 2026, a 24% increase compared to $56.3 million in Q3 2025 and a 38% increase compared to $50.5 million in Q2 2026. Total net product sales includes approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026.
•Total operating expenses were $93.3 million in Q3 2026, a 7% increase compared to $87.5 million in Q3 2025 and an 18% decrease compared to $114.3 million in Q2 2026.
•Fanapt® net product sales were $38.8 million in Q3 2026, a 24% increase compared to $31.2 million in Q3 2025 and an 8% increase compared to $36.0 million in Q2 2026.
•HETLIOZ® net product sales were $21.7 million in Q3 2026, a 21% increase compared to $18.0 million in Q3 2025 and a 289% increase compared to $5.6 million in Q2 2026, and includes orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders were recognized as revenue in Q3 2026.
•PONVORY® net product sales were $7.7 million in Q3 2026, a 10% increase compared to $7.0 million in Q3 2025 and a 2% decrease compared to $7.9 million in Q2 2026.
•NEREUSTM net product sales were $1.6 million in Q3 2026, a 60% increase compared to $1.0 million in Q2 2026. Vanda launched NEREUSTM commercially in the U.S. in Q2 2026, with the direct-to-consumer offering via the web portal nereus.us, and began sales force promotion in Q3 2026.
•Loss before income taxes was $22.4 million in Q3 2026 compared with $28.4 million in Q3 2025.
•Cash, cash equivalents and marketable securities (Cash) totaled $140.5 million as of September 30, 2026, representing a decrease to Cash of $29.5 million in Q3 2026.
First Nine Months of 2026
•Total net product sales were $172.1 million in the first nine months of 2026, an 8% increase compared to $158.9 million in the first nine months of 2025.
•Total operating expenses were $309.6 million in the first nine months of 2026, a 15% increase compared to $269.7 million in the first nine months of 2025.
•Fanapt® net product sales were $104.3 million in the first nine months of 2026, a 24% increase compared to $84.1 million in the first nine months of 2025.
•HETLIOZ® net product sales were $43.2 million in the first nine months of 2026, a 21% decrease compared to $55.0 million in the first nine months of 2025.
•PONVORY® net product sales were $21.9 million in the first nine months of 2026, an 11% increase compared to $19.8 million in the first nine months of 2025.
•NEREUSTM net product sales were $2.6 million in the first nine months of 2026.
•Loss before income taxes was $133.2 million in the first nine months of 2026 compared with $100.6 million in the first nine months of 2025.
•Cash, cash equivalents and marketable securities (Cash) totaled $140.5 million as of September 30, 2026, representing a decrease to Cash of $123.4 million compared to December 31, 2025.
Key Commercial Highlights
•Fanapt® saw continued strong momentum in Q3 2026, with total prescriptions (TRx)1 up 25% and new-to-brand prescriptions (NBRx)1 up 18% versus Q3 2025. Since commercial expansion following the approval of bipolar disorder, Fanapt® has seen significant growth, with TRx1 up 72% and NBRx1 up 306% versus Q2 2024.
•BYSANTITM received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia in Q1 2026 and is expected to launch in Q4 2026. BYSANTITM is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044.
•Vanda launched NEREUSTM commercially in the U.S. in Q2 2026, with the direct-to-consumer offering via the web portal nereus.us, and began sales force promotion in Q3 2026. During Q3 2026, the NEREUS™ launch showed strong growth in both total prescriptions and unique prescribers as compared to Q2 2026.
Key Regulatory & Clinical Development Highlights
Recent & Upcoming Milestones
•In October 2026, Vanda announced positive results from the Phase III clinical study, VP-VLY-686-3601, of NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy. Vanda intends to discuss the results with the FDA and plans to submit a supplemental New Drug Application (sNDA) seeking approval of NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy.
•In September 2026, Vanda announced positive topline results from the pivotal Phase III study of HETLIOZ® in adults with Delayed Sleep-Wake Phase Disorder (DSWPD). Vanda intends to discuss these data with the FDA and to submit an sNDA seeking approval of HETLIOZ® for DSWPD. If approved, HETLIOZ® would be the first FDA-approved medicine indicated for this condition.
•The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA 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.
•The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing, with results expected in the first half of 2027. The study is enrolling patients in 54 sites in the U.S. and Europe and has enrolled 55% of the 500 patient enrollment target. The primary endpoint of the study is the change from baseline to week 6 of the Montgomery-Asberg Depression Rating Scale (MADRS) comparing milsaperidone and placebo. Secondary endpoints include Clinical Global Impression – Severity (CGI-S) and Clinical Global Impression – Change (CGI-C).
Regulatory Proceedings
•Vanda continues to progress the FDA formal hearing regarding HETLIOZ® for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the D.C. Circuit set aside the FDA’s prior refusal to approve the application, is advancing according to schedule and is expected to culminate in a five-day hearing before the Administrative Law Judge from December 14, 2026 to December 18, 2026.
•Vanda continues to pursue its legal challenge to FDA’s final order refusing to hold a hearing or to approve the Company’s sNDA for HETLIOZ® in the treatment of insomnia. Following oral argument before the U.S. Court of Appeals for the D.C. Circuit in September 2026, the matter is awaiting decision.
•Vanda continues to pursue its legal challenge to FDA’s final order refusing to hold a hearing or to approve the Company’s NDA for NEREUS™ in gastroparesis. Briefing is currently underway before the DC Circuit, and is due to be completed in mid-November.
GAAP Financial Results
Net loss was $22.6 million (diluted loss per share of $0.37) in Q3 2026 compared with a net loss of $22.6 million (diluted loss per share of $0.38) in Q3 2025 and a net loss of $62.5 million (diluted net loss per share of $1.04) in Q2 2026.
Net loss was $133.6 million (diluted loss per share of $2.23) in the first nine months of 2026 compared with a net loss of $79.3 million (diluted loss per share of $1.35) in the first nine months of 2025.
2026 Financial Guidance
Vanda is updating its 2026 financial guidance and expects to achieve total revenue for full year 2026 of greater than $240 million.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, October 28, 2026, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 2026 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 1178705. A replay of the call will be available on Wednesday, October 28, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, November 4, 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 1178705.
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 the expected timing of the commercial launch of BYSANTI™ for the treatment of bipolar I disorder and schizophrenia; the anticipated timing of the completion of the FDA’s review of the Quimilza™ BLA for the treatment of GPP; Vanda’s plans and expectations regarding the regulatory path for NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy; Vanda’s clinical development and regulatory plans and expected timeline for HETLIOZ® in the treatment of DSWPD; Vanda’s expectations with respect to its operating expense run rate; Vanda’s clinical development plans and expected timeline for BYSANTI™ for the treatment of MDD; Vanda’s continued pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder and Vanda’s expectations with respect to the HETLIOZ® evidentiary hearing; Vanda’s continued pursuit of FDA approval of HETLIOZ® for the treatment of insomnia and NEREUS™ for the treatment of gastroparesis; 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; Vanda’s ability to successfully execute the commercial launch of BYSANTI™ for the treatments of bipolar I disorder and schizophrenia in Q4 2026; Vanda’s ability to successfully launch and commercialize its recently approved products and any product that may be approved in the future; Vanda’s ability to continue to reduce its operating expenses; the FDA’s ability to complete its review of, and reach a decision with respect to, the BLA for Quimilza™ by December 12, 2026; the FDA’s willingness to meet with Vanda to discuss the NEREUS™ Phase III clinical study results and Vanda’s ability to gain alignment with the FDA on the regulatory path for NEREUS™ and submit an sNDA for NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy; the FDA’s willingness to meet with Vanda to discuss the HETLIOZ® Phase III clinical study results and Vanda’s ability to gain alignment with the FDA on the regulatory path for HETLIOZ® in the treatment of DSWPD and to obtain regulatory approval of HETLIOZ® for this indication; Vanda’s ability to meet its enrollment target for, and complete, the Phase III study for BYSANTI™ for the treatment of MDD and receive results in the first half of 2027; and the outcomes of the administrative hearing process for HETLIOZ® for the treatment of jet lag disorder and the court cases for HETLIOZ® for the treatment of insomnia and NEREUS™ for the treatment of gastroparesis. 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 | Nine Months Ended | ||||||||||||||||||||||
| September 30 2026 | September 30 2025 | September 30 2026 | September 30 2025 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
Fanapt® net product sales | $ | 38,765 | $ | 31,245 | $ | 104,314 | $ | 84,084 | |||||||||||||||
HETLIOZ® net product sales | 21,689 | 17,978 | 43,212 | 55,042 | |||||||||||||||||||
PONVORY® net product sales | 7,749 | 7,035 | 21,895 | 19,763 | |||||||||||||||||||
NEREUSTM net product sales | 1,612 | — | 2,641 | — | |||||||||||||||||||
| Total revenues | 69,815 | 56,258 | 172,062 | 158,889 | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of goods sold excluding amortization | 4,152 | 2,954 | 10,871 | 9,211 | |||||||||||||||||||
| Research and development | 27,622 | 22,563 | 93,010 | 80,265 | |||||||||||||||||||
| Selling, general and administrative | 59,575 | 60,273 | 199,774 | 174,973 | |||||||||||||||||||
| Intangible asset amortization | 1,987 | 1,752 | 5,961 | 5,255 | |||||||||||||||||||
| Total operating expenses | 93,336 | 87,542 | 309,616 | 269,704 | |||||||||||||||||||
| Loss from operations | (23,521) | (31,284) | (137,554) | (110,815) | |||||||||||||||||||
| Other income, net | 1,133 | 2,894 | 4,358 | 10,170 | |||||||||||||||||||
| Loss before income taxes | (22,388) | (28,390) | (133,196) | (100,645) | |||||||||||||||||||
| Provision (benefit) for income taxes | 174 | (5,804) | 446 | (21,358) | |||||||||||||||||||
Net loss | $ | (22,562) | $ | (22,586) | $ | (133,642) | $ | (79,287) | |||||||||||||||
Net loss per share, basic | $ | (0.37) | $ | (0.38) | $ | (2.23) | $ | (1.35) | |||||||||||||||
| Net loss per share, diluted | $ | (0.37) | $ | (0.38) | $ | (2.23) | $ | (1.35) | |||||||||||||||
Weighted average shares outstanding, basic | 60,465,170 | 59,091,478 | 60,054,252 | 58,873,268 | |||||||||||||||||||
| Weighted average shares outstanding, diluted | 60,465,170 | 59,091,478 | 60,054,252 | 58,873,268 | |||||||||||||||||||
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| September 30 2026 | December 31 2025 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 61,933 | $ | 84,851 | |||||||
| Marketable securities | 78,561 | 178,996 | |||||||||
| Accounts receivable, net | 60,316 | 54,578 | |||||||||
| Inventory | 1,528 | 1,852 | |||||||||
| Prepaid expenses and other current assets | 36,129 | 26,985 | |||||||||
| Total current assets | 238,467 | 347,262 | |||||||||
| Property and equipment, net | 3,029 | 2,248 | |||||||||
| Operating lease right-of-use assets | 14,225 | 3,923 | |||||||||
| Finance lease right-of-use assets | 5,949 | 7,343 | |||||||||
| Intangible assets, net | 111,128 | 117,089 | |||||||||
| Non-current inventory and other | 9,529 | 11,083 | |||||||||
| Total assets | $ | 382,327 | $ | 488,948 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued liabilities | $ | 60,588 | $ | 68,297 | |||||||
| Product revenue allowances | 94,392 | 76,865 | |||||||||
| Total current liabilities | 154,980 | 145,162 | |||||||||
| Operating lease non-current liabilities | 14,949 | 2,991 | |||||||||
| Finance lease non-current liabilities | 2,345 | 4,076 | |||||||||
| Other non-current liabilities | 10,195 | 9,533 | |||||||||
| Total liabilities | 182,469 | 161,762 | |||||||||
| Stockholders’ equity: | |||||||||||
| Common stock | 60 | 59 | |||||||||
| Additional paid-in capital | 728,272 | 721,264 | |||||||||
| Accumulated other comprehensive income (loss) | (66) | 629 | |||||||||
| Accumulated deficit | (528,408) | (394,766) | |||||||||
| Total stockholders’ equity | 199,858 | 327,186 | |||||||||
| Total liabilities and stockholders’ equity | $ | 382,327 | $ | 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
Follow us on X @vandapharma