Vanda Pharmaceuticals (Nasdaq: VNDA) Q2 loss deepens as it funds launches
Rhea-AI Filing Summary
Vanda Pharmaceuticals reported Q2 2026 total revenues of $50.5 million, down 4% year-over-year, as Fanapt net product sales grew 23% to $36.0 million while HETLIOZ declined 66% to $5.6 million. Net loss widened to $62.5 million (diluted loss per share $1.04) as R&D and SG&A spending increased.
Cash, cash equivalents and marketable securities totaled $170.0 million at June 30, 2026, and the company expects its resources and anticipated revenues to fund operations through at least the end of 2027. Management reiterated 2026 total revenue guidance of $240 to $290 million and highlighted FDA approval of milsaperidone for bipolar I disorder and schizophrenia, NEREUS commercial launch, an imsidolimab BLA with a December 12, 2026 PDUFA date, multiple Phase III readouts through early 2027, and ongoing proceedings to seek HETLIOZ approval for jet lag disorder.
Positive
- Pipeline and launch momentum: FDA approval of milsaperidone for bipolar I disorder and schizophrenia in Q1 2026, NEREUS commercial availability in Q2 2026, and an imsidolimab BLA with a December 12, 2026 PDUFA date create several potential future commercial opportunities.
- Strong Fanapt growth: Fanapt net product sales rose 23% year-over-year in Q2 2026 to $36.0 million, with total prescriptions up 31% and new-to-brand prescriptions up 32%, underpinning the company’s guidance for higher product revenues.
Negative
- Widening losses and cash burn: Net loss increased to $62.5 million in Q2 2026 from $27.2 million a year earlier, and cash, cash equivalents and marketable securities declined by $93.8 million in the first six months of 2026 compared to December 31, 2025.
Filing Explained
As of June 30, 2026, liquidity was $55,882 thousand in cash and $114,147 thousand in securities, down $93.8 million from year-end.
Form 8-K reports specified material events; here, Vanda furnished its completed second-quarter 2026 results through an attached press release.
At
Approximately
The HETLIOZ jet-lag regulatory proceeding remains in progress; the company says it is expected to culminate in a five-day administrative-law-judge hearing in
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, and exhibit attachments filed with this report.
Key Figures
Q2 2026 total revenues: $50.5 million
Q2 2026 Fanapt net product sales: $36.0 million
Q2 2026 HETLIOZ net product sales: $5.6 million
+4 more
7 metrics
Q2 2026 total revenues
$50.5 million
Quarter ended June 30, 2026, down 4% from $52.6 million in Q2 2025
Q2 2026 Fanapt net product sales
$36.0 million
Up 23% year-over-year in Q2 2026
Q2 2026 HETLIOZ net product sales
$5.6 million
Down 66% year-over-year in Q2 2026, excluding $7.0 million to be recognized in Q3
Q2 2026 PONVORY net product sales
$7.9 million
Up 12% year-over-year in Q2 2026
Q2 2026 net loss
$62.5 million
Net loss in Q2 2026 versus $27.2 million in Q2 2025
Cash, cash equivalents and marketable securities
$170.0 million
As of June 30, 2026, a decrease of $93.8 million from December 31, 2025
2026 total revenue guidance
$240 to $290 million
Full-year 2026 total revenue guidance range
Key Terms
Biologics License Application (BLA), PDUFA target action date, orphan drug designation, Rare Pediatric Disease Designation, +1 more
5 terms
Biologics License Application (BLA) regulatory
"The Biologics License Application (BLA) for imsidolimab in GPP is under review"
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
"BLA for imsidolimab in GPP under review by the FDA; PDUFA target action date of December 12, 2026"
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.
orphan drug designation regulatory
"Japan's MHLW granted orphan drug designation to imsidolimab for the treatment of GPP"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Rare Pediatric Disease Designation regulatory
"the FDA had granted Rare Pediatric Disease Designation to VCA-894A for CMT2S"
A rare pediatric disease designation is an official regulatory status given to a drug or therapy that targets a serious or life‑threatening condition primarily affecting children and is uncommon in the population. It matters to investors because the status often brings financial and development perks — such as tax credits, reduced fees, faster review and periods of market protection — which can lower costs, speed approval and improve the commercial outlook; think of it as a VIP pass that makes bringing a scarce, child‑focused treatment to market easier and potentially more profitable.
Phase III study medical
"The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder"
A phase III study is the large, late-stage clinical test that measures whether an experimental drug or medical treatment works and is safe in a broad group of patients; think of it as the full dress rehearsal before asking regulators to approve a product. Results matter to investors because positive outcomes and clear safety profiles greatly increase the chances of regulatory approval and future sales, while negative or ambiguous results can halt a program and affect a company’s value.
Earnings Snapshot
Q2 2026 total revenues: $50.5 million · Guidance included
Quarter and six months ended June 30, 2026
Q2 2026 total revenues
$50.5 million
Decreased 4% from $52.6 million in Q2 2025.
Q2 2026 net loss
$62.5 million
Widened from $27.2 million in Q2 2025.
Cash, cash equivalents and marketable securities
$170.0 million
Decreased by $93.8 million compared to December 31, 2025.
Guidance
Vanda reiterated 2026 total revenue guidance of $240 to $290 million, including $150 to $170 million from Fanapt and BYSANTI and $10 to $30 million from NEREUS.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Vanda Pharmaceuticals (VNDA) Q2 2026 revenues and net loss?
Vanda reported Q2 2026 revenue of $50.5 million and a net loss of $62.5 million, or $1.04 per diluted share. Revenue fell 4% year-over-year, while higher R&D and selling expenses drove a much larger loss than the $27.2 million reported in Q2 2025.
How did Fanapt sales perform for Vanda (VNDA) in Q2 2026?
Fanapt net product sales reached $36.0 million in Q2 2026, up 23% year-over-year. Total prescriptions grew 31% and new-to-brand prescriptions increased 32% versus Q2 2025, reflecting continued uptake following the bipolar disorder indication and supporting management’s focus on this franchise.
What is Vanda Pharmaceuticals (VNDA) 2026 revenue guidance?
For 2026, Vanda projects total revenues of $240 to $290 million. Within this, Fanapt and BYSANTI net product sales are guided to $150 to $170 million, NEREUS to $10 to $30 million, and other products to $80 to $90 million for the full year.
How much cash does Vanda (VNDA) have and what is its runway?
Vanda held $170.0 million in cash, cash equivalents and marketable securities as of June 30, 2026. Management states that, based on this cash position and anticipated product revenues, it expects to have sufficient resources to fund operations through at least the end of 2027.
What key regulatory milestones are upcoming for Vanda (VNDA)?
The BLA for imsidolimab in GPP is under FDA review with a December 12, 2026 PDUFA date. Multiple Phase III readouts are expected in 2026 for NEREUS, VQW-765 and HETLIOZ, plus an MDD study in early 2027, alongside an FDA evidentiary hearing on HETLIOZ for jet lag.
What new products is Vanda Pharmaceuticals (VNDA) launching?
Milsaperidone received FDA approval in Q1 2026 for bipolar I disorder and schizophrenia, with launch expected in H2 2026. NEREUS for prevention of vomiting induced by motion became commercially available in Q2 2026 via a direct-to-consumer web portal, with personal promotion planned later in 2026.
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): August 5, 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 August 5, 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 June 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 August 5, 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: | August 5, 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 Second Quarter 2026 Financial Results
•Fanapt® Q2 2026 net product sales increased 23% to $36.0 million; total prescriptions increased 31%
•Full-year 2026 total revenue guidance of $240-$290 million
•Cash totaled $170.0 million as of June 30, 2026; expected to fund operations through at least the end of 2027
•BYSANTITM (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia in Q1 2026; commercial launch expected in second half of 2026
•QuimilzaTM (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026
•NEREUS™ for prevention of vomiting induced by motion became commercially available in Q2 2026
•Results for three Phase III clinical trials expected by end of 2026:
◦NEREUS™ (tradipitant) in vomiting in GLP-1,
◦VQW-765 in social anxiety disorder
◦HETLIOZ® (tasimelteon) in delayed sleep phase disorder
WASHINGTON – August 5, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2026.
“We are pleased with the continued strong growth of Fanapt and the enthusiastic early response to NEREUS as it becomes available to patients. With BYSANTI approved and on track for launch in the second half of 2026, a December 2026 PDUFA date for Quimilza and multiple late-stage clinical trial results expected before year-end, we believe Vanda is well positioned for meaningful commercial expansion and pipeline value creation,” said Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board. “As our Phase III programs, launch preparations, and commercial supply manufacturing near completion, we expect operating expenses to begin moderating later this year and more significantly in 2027. Our current resources, together with anticipated product revenues, provide a solid foundation to advance our objectives through at least the end of 2027.”
Financial Highlights
•During 2025 and 2026, we have advanced multiple Phase III programs, continued execution on the commercialization of Fanapt® (iloperidone) 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 these activities conclude, Vanda expects operating expenses to begin decreasing by the end of 2026 and more substantially throughout 2027. Based on its current cash position and anticipated revenues, Vanda expects to have sufficient resources to fund operations through at least the end of 2027.
Second Quarter of 2026
•Total net product sales were $50.5 million in Q2 2026, a 4% decrease compared to $52.6 million in Q2 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026.
•Fanapt® net product sales were $36.0 million in Q2 2026, up 23% year-over-year.
•HETLIOZ® (tasimelteon) net product sales were $5.6 million in Q2 2026, down 66% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026.
•PONVORY® net product sales were $7.9 million in Q2 2026, up 12% year-over-year.
•NEREUSTM net product sales were $1.0 million in Q2 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026.
•Loss before income taxes was $62.4 million in Q2 2026 compared with $34.9 million in Q2 2025, reflecting continued investment in new product launches and pipeline advancement.
•Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $32.3 million in Q2 2026.
First Six Months of 2026
•Total net product sales were $102.2 million in the first six months of 2026 as compared to $102.6 million in the first six months of 2025. Total net product sales does not include approximately $7.0 million of HETLIOZ® revenue for orders shipped on June 29, 2026 that arrived on July 1, 2026.
•Fanapt® net product sales were $65.5 million in the first six months of 2026, up 24% year-over-year.
•HETLIOZ® net product sales were $21.5 million in the first six months of 2026, down 42% year-over-year, and do not include orders totaling approximately $7.0 million in revenue that were shipped on June 29, 2026 and arrived on July 1, 2026. These orders will be recognized as revenue in Q3 2026.
•PONVORY® net product sales were $14.1 million in the first six months of 2026, up 11% year-over-year.
•NEREUSTM net product sales were $1.0 million in the first six months of 2026. NEREUSTM launched commercially in the U.S. in Q2 2026 with the direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026.
•Loss before income taxes was $110.8 million in the first six months of 2026 compared with $72.3 million in the first six months of 2025, reflecting continued investment in new product launches and pipeline advancement.
•Cash, cash equivalents and marketable securities (Cash) totaled $170.0 million as of June 30, 2026, representing a decrease to Cash of $93.8 million compared to December 31, 2025.
Key Commercial Highlights
•Fanapt® saw continued strong momentum in Q2 2026, with total prescriptions (TRx)1 up 31% and new-to-brand prescriptions (NBRx)1 up 32% versus Q2 2025. Since commercial expansion following the approval of bipolar disorder, Fanapt® has seen significant growth, with TRx1 up 62% and NBRx1 up 300% 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 the second half of 2026. BYSANTITM is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044.
•In May 2026, the early commercial launch of NEREUSTM was initiated with a direct-to-consumer offering via the web portal nereus.us. Personal promotion is expected to commence later in 2026.
Key Regulatory & Clinical Development Highlights
Upcoming Clinical Milestones
•Vanda’s ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including:
◦The Thetis Phase III study of NEREUSTM 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 in 2026.
◦The Phase III study of HETLIOZ® in the treatment of delayed sleep phase disorder (DSPD), with results expected in 2026.
◦The Phase III study of BYSANTITM as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in the first half of 2027.
Other Updates
•The Biologics License Application (BLA) for QuimilzaTM 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.
•In May 2026, Vanda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation to QuimilzaTM for the treatment of GPP. In July 2026, Vanda announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) had adopted a positive opinion recommending orphan drug designation for QuimilzaTM for the treatment of GPP.
•In July 2026, Vanda announced that the FDA had granted Rare Pediatric Disease Designation to VCA-894A, Vanda's investigational antisense oligonucleotide therapy for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), a rare, serious, and progressive inherited neurological disorder.
•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 in December 2026.
GAAP Financial Results
Net loss was $62.5 million (diluted loss per share of $1.04) in Q2 2026 compared with a net loss of $27.2 million (diluted loss per share of $0.46) in Q2 2025.
Net loss was $111.1 million (diluted loss per share of $1.86) in the first six months of 2026 compared with a net loss of $56.7 million (diluted loss per share of $0.96) in the first six months of 2025.
2026 Financial Guidance
Vanda is reiterating its 2026 total revenue guidance and expects to achieve the following financial objectives in 2026:
Full Year 2026 Financial Objectives | Full Year 2026 Guidance | ||||
| Total revenues | $240 to $290 million | ||||
Fanapt® and BYSANTITM net product sales* | $150 to $170 million | ||||
NEREUSTM net product sales | $10 to $30 million | ||||
| Other net product sales | $80 to $90 million | ||||
*Now includes contribution from both Fanapt® and BYSANTI™ based on expected BYSANTI™ launch timing.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, August 5, 2026, at 4:30 PM ET. During the call, Vanda’s management will discuss the second 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 1843107. A replay of the call will be available on Wednesday, August 5, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, August 12, 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 1843107.
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 expectations with respect to its ability to fund its operations through at least the end of 2027; the expected timing of the commercial launch of BYSANTITM for the treatment of bipolar I disorder and schizophrenia; the anticipated timing of the completion of the FDA’s review of the QuimilzaTM BLA for the treatment of GPP; Vanda’s clinical development plans and expected timelines for NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, HETLIOZ® in the treatment of DSPD, and BYSANTITM for the treatment of MDD; Vanda’s expectations with respect to its commercial expansion and ability to create value from its product pipeline; Vanda’s expectations with respect to its operating expense run rate through 2027; the anticipated timing of the commencement of personal promotion of NEREUSTM; 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; 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 reduce its operating expenses, conserve cash and generate enough revenue to fund its operations through at least the end of 2027; Vanda’s ability to successfully execute the commercial launch of BYSANTITM for the treatments of bipolar I disorder and schizophrenia in the second half of 2026; the FDA’s ability to complete its review of, and reach a decision with respect to, the BLA for QuimilzaTM by December 12, 2026; 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 Phase III studies for NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, VQW-765 in the treatment of adults with social anxiety disorder, and HETLIOZ® in the treatment of DSPD and receive the respective study results by the end of 2026; Vanda’s ability to complete the Phase III study for BYSANTITM for the treatment of MDD and receive results in the first half of 2027; Vanda’s ability to commence personal promotion of NEREUS™ for the prevention of vomiting induced by motion in 2026; and the outcome of the administrative hearing process for 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 | Six Months Ended | ||||||||||||||||||||||
| June 30 2026 | June 30 2025 | June 30 2026 | June 30 2025 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
Fanapt® net product sales | $ | 35,989 | $ | 29,294 | $ | 65,549 | $ | 52,839 | |||||||||||||||
HETLIOZ® net product sales | 5,576 | 16,192 | 21,523 | 37,064 | |||||||||||||||||||
PONVORY® net product sales | 7,935 | 7,104 | 14,146 | 12,728 | |||||||||||||||||||
NEREUSTM net product sales | 1,029 | — | 1,029 | — | |||||||||||||||||||
| Total revenues | 50,529 | 52,590 | 102,247 | 102,631 | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of goods sold excluding amortization | 3,560 | 2,736 | 6,719 | 6,257 | |||||||||||||||||||
| Research and development | 36,953 | 21,990 | 65,388 | 57,702 | |||||||||||||||||||
| Selling, general and administrative | 71,838 | 64,616 | 140,199 | 114,700 | |||||||||||||||||||
| Intangible asset amortization | 1,987 | 1,751 | 3,974 | 3,503 | |||||||||||||||||||
| Total operating expenses | 114,338 | 91,093 | 216,280 | 182,162 | |||||||||||||||||||
| Loss from operations | (63,809) | (38,503) | (114,033) | (79,531) | |||||||||||||||||||
| Other income, net | 1,425 | 3,616 | 3,225 | 7,276 | |||||||||||||||||||
| Loss before income taxes | (62,384) | (34,887) | (110,808) | (72,255) | |||||||||||||||||||
| Provision (benefit) for income taxes | 129 | (7,680) | 272 | (15,554) | |||||||||||||||||||
Net loss | $ | (62,513) | $ | (27,207) | $ | (111,080) | $ | (56,701) | |||||||||||||||
Net loss per share, basic | $ | (1.04) | $ | (0.46) | $ | (1.86) | $ | (0.96) | |||||||||||||||
| Net loss per share, diluted | $ | (1.04) | $ | (0.46) | $ | (1.86) | $ | (0.96) | |||||||||||||||
Weighted average shares outstanding, basic | 60,226,570 | 58,993,990 | 59,845,391 | 58,762,358 | |||||||||||||||||||
| Weighted average shares outstanding, diluted | 60,226,570 | 58,993,990 | 59,845,391 | 58,762,358 | |||||||||||||||||||
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
| June 30 2026 | December 31 2025 | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 55,882 | $ | 84,851 | |||||||
| Marketable securities | 114,147 | 178,996 | |||||||||
| Accounts receivable, net | 59,692 | 54,578 | |||||||||
| Inventory | 1,678 | 1,852 | |||||||||
| Prepaid expenses and other current assets | 33,085 | 26,985 | |||||||||
| Total current assets | 264,484 | 347,262 | |||||||||
| Property and equipment, net | 2,578 | 2,248 | |||||||||
| Operating lease right-of-use assets | 14,598 | 3,923 | |||||||||
| Finance lease right-of-use assets | 6,772 | 7,343 | |||||||||
| Intangible assets, net | 113,115 | 117,089 | |||||||||
| Non-current inventory and other | 10,920 | 11,083 | |||||||||
| Total assets | $ | 412,467 | $ | 488,948 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued liabilities | $ | 69,994 | $ | 68,297 | |||||||
| Product revenue allowances | 94,032 | 76,865 | |||||||||
| Total current liabilities | 164,026 | 145,162 | |||||||||
| Operating lease non-current liabilities | 15,027 | 2,991 | |||||||||
| Finance lease non-current liabilities | 3,175 | 4,076 | |||||||||
| Other non-current liabilities | 10,054 | 9,533 | |||||||||
| Total liabilities | 192,282 | 161,762 | |||||||||
| Stockholders’ equity: | |||||||||||
| Common stock | 60 | 59 | |||||||||
| Additional paid-in capital | 725,933 | 721,264 | |||||||||
| Accumulated other comprehensive income | 38 | 629 | |||||||||
| Accumulated deficit | (505,846) | (394,766) | |||||||||
| Total stockholders’ equity | 220,185 | 327,186 | |||||||||
| Total liabilities and stockholders’ equity | $ | 412,467 | $ | 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