Vanda Pharmaceuticals Reports Third Quarter 2025 Financial Results

Vanda Pharmaceuticals Reports Third Quarter 2025 Financial Results News provided by Vanda Pharmaceuticals Inc. Oct 29, 2025, 16:01 ET Share this article Share to X Share this article Share to X Fanapt ® Q3 2025 net product sales increased by 31% to $31.2 million compared to Q3 2024 Bysanti TM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness under review by the FDA; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in Q4 2025 Vanda announced collaborative framework with the FDA for resolution of certain disputes Re-review of Vanda's sNDA for HETLIOZ ® for the treatment of jet lag disorder by January 7, 2026 WASHINGTON , Oct. 29, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA ) today announced financial and operational results for the third quarter ended September 30, 2025. "This quarter reflects strong commercial execution, with total net product sales reaching $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions. HETLIOZ continues to deliver stable performance with $18.0 million in Q3 sales," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We are particularly encouraged by our advancing pipeline, with multiple near-term regulatory milestones: the tradipitant NDA for motion sickness under FDA review with a PDUFA target action date of December 30, 2025; the Bysanti NDA for bipolar I disorder and schizophrenia also under FDA review with a PDUFA target action date of February 21, 2026; and the anticipated Q4 submission of the imsidolimab BLA for generalized pustular psoriasis. We are also investing strategically in our commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. We believe that these milestones, combined with our collaborative framework with the FDA, will position Vanda for sustained growth and expanded therapeutic impact in 2026 and beyond." Financial Highlights Third Quarter of 2025 Total net product sales from Fanapt ® , HETLIOZ ® and PONVORY ® were $56.3 million in the third quarter of 2025, an 18% increase compared to $47.7 million in the third quarter of 2024. Fanapt ® net product sales were $31.2 million in the third quarter of 2025, a 31% increase compared to $23.9 million in the third quarter of 2024. HETLIOZ ® net product sales were $18.0 million in the third quarter of 2025, a 1% increase compared to $17.9 million in the third quarter of 2024. PONVORY ® net product sales were $7.0 million in the third quarter of 2025, a 20% increase compared to $5.9 million in the third quarter of 2024. Net loss was $22.6 million in the third quarter of 2025 compared to net loss of $5.3 million in the third quarter of 2024. Cash, cash equivalents and marketable securities (Cash) was $293.8 million as of September 30, 2025, representing a decrease to Cash of $31.8 million compared to June 30, 2025. First Nine Months of 2025 Total net product sales from Fanapt ® , HETLIOZ ® and PONVORY ® were $158.9 million in the first nine months of 2025, a 9% increase compared to $145.6 million in the first nine months of 2024. Fanapt ® net product sales were $84.1 million in the first nine months of 2025, a 24% increase compared to $67.6 million in the first nine months of 2024. HETLIOZ ® net product sales were $55.0 million in the first nine months of 2025, a 3% decrease compared to $56.6 million in the first nine months of 2024. PONVORY ® net product sales were $19.8 million in the first nine months of 2025, a 7% decrease compared to $21.3 million in the first nine months of 2024. Net loss was $79.3 million in the first nine months of 2025 compared to net loss of $14.0 million in the first nine months of 2024. Cash was $293.8 million as of September 30, 2025, representing a decrease to Cash of $80.9 million compared to December 31, 2024. Key Operational Highlights – Commercial Fanapt ® experienced significant growth, with total prescriptions (TRx) 1 increasing by 35% and Fanapt ® net product sales increasing by 31% in the third quarter of 2025 as compared to the third quarter of 2024. During the first nine months of 2025, Vanda's direct-to-consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for the company and its products, Fanapt ® and PONVORY ® . The Company maintained strategic investments in its commercial infrastructure, including increased brand visibility through targeted sponsorships, with the goal of supporting long-term market leadership and future commercial launches. Key Operational Highlights – Regulatory & Clinical Development A clinical study of tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy ® (semaglutide), is now complete. Results are expected in the fourth quarter of 2025. On October 1, 2025, Vanda announced that it had agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ ® (tasimelteon) and tradipitant. Pursuant to the agreement: The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of Vanda's New Drug Application (NDA) for this indication, with the existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. The FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ ® for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. Bysanti™ NDA for bipolar I disorder and schizophrenia is under review by the FDA with a 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 the fourth quarter of 2025. The Phase III study of the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention is enrolling patients. A clinical study of the long acting injectable formulation of iloperidone in people with treatment-resistant hypertension is ongoing and Vanda plans to begin enrolling patients soon. GAAP Financial Results Net loss was $22.6 million in the third quarter of 2025 compared to net loss of $5.3 million in the third quarter of 2024. Diluted net loss per share was $0.38 in the third quarter of 2025 compared to diluted net loss per share of $0.09 in the third quarter of 2024. Net loss was $79.3 million in the first nine months of 2025 compared to net loss of $14.0 million in the first nine months of 2024. Diluted net loss per share was $1.35 in the first nine months of 2025 compared to diluted net loss per share of $0.24 in the first nine months of 2024. 2025 Financial Guidance Vanda is updating its 2025 financial guidance and expects to achieve the following financial objectives in 2025: Full Year 2025 Financial Objectives Prior Full Year 2025 Guidance Revised Full Year 2025 Guidance Total revenues $210 to $250 million $210 to $230 million Year-end 2025 Cash $280 to $320 million $260 to $290 million Conference Call Vanda has scheduled a conference call for today, Wednesday, October 29, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the third quarter 2025 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8728050. A replay of the call will be available on Wednesday, October 29, 2025, beginning at 7:00 PM ET and will be accessible until Wednesday, November 5, 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 8728050. The conference call will be broadcast simultaneously on Vanda's website, www.vandapharma.com . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References 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 and prospects for approval; the goals and expected results of Vanda's commercial infrastructure investment strategy; Vanda's expectations with respect to the strength of its business; Vanda's clinical development plans and expected timelines for tradipitant in the prevention of vomiting induced by Wegovy ® , BysantiTM for the treatment of MDD and the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension; and the actions that the FDA is expected to take, and the timing thereof, with respect to the NDA for tradipitant for the treatment of motion sickness and the sNDA for HETLIOZ ® for the treatment of jet lag disorder 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 the fourth quarter of 2025; Vanda's ability to achieve long-term market leadership and execute new commercial launches through its commercial infrastructure investments; Vanda's ability to complete the clinical studies for tradipitant in the prevention of vomiting induced by Wegovy ® and BysantiTM for the treatment of MDD and receive results in the expected timeframes; Vanda's ability to complete enrollment of patients in the clinical study for the long acting injectable formulation of iloperidone in the treatment of schizophrenia in relapse-prevention and to begin enrolling patients in the study of the long acting injectable formulation of iloperidone for the treatment of hypertension in the expected timeframe; and the FDA's ability to conduct expedited re-reviews of the partial clinical hold on tradipitant for the treatment of motion sickness by November 26, 2025 and the sNDA for HETLIOZ ® for the treatment of jet lag disorder by January 7, 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 Nine Months Ended September 30 2025 September 30 2024 September 30 2025 September 30 2024 Revenues: Fanapt ® net product sales $ 31,245 $ 23,919 $ 84,084 $ 67,648 HETLIOZ ® net product sales 17,978 17,870 55,042 56,631 PONVORY ® net product sales 7,035 5,862 19,763 21,308 Total revenues 56,258 47,651 158,889 145,587 Operating expenses: Cost of goods sold excluding amortization 2,954 2,551 9,211 8,724 Research and development 22,563 16,776 80,265 54,591 Selling, general and administrative 60,273 37,573 174,973 107,132 Intangible asset amortization 1,752 1,751 5,255 5,521 Total operating expenses 87,542 58,651 269,704 175,968 Loss from operations (31,284) (11,000) (110,815) (30,381) Other income, net 2,894 4,756 10,170 13,957 Loss before income taxes (28,390) (6,244) (100,645) (16,424) Benefit for income taxes (5,804) (920) (21,358) (2,436) Net loss $ (22,586) $ (5,324) $ (79,287) $ (13,988) Net loss per share, basic $ (0.38) $ (0.09) $ (1.35) $ (0.24) Net loss per share, diluted $ (0.38) $ (0.09) $ (1.35) $ (0.24) Weighted average shares outstanding, basic 59,091,478 58,261,961 58,873,268 58,095,566 Weighted average shares outstanding, diluted 59,091,478 58,261,961 58,873,268 58,095,566 VANDA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) September 30 2025 December 31 2024 ASSETS Current assets: Cash and cash equivalents $ 70,022 $ 102,316 Marketable securities 223,730 272,327 Accounts receivable, net 50,541 47,101 Inventory 2,042 1,726 Prepaid expenses and other current assets 21,161 15,420 Total current assets 367,496 438,890 Property and equipment, net 2,460 2,132 Operating lease right-of-use assets 4,368 5,602 Finance lease right-of-use assets 5,071 4,943 Intangible assets, net 108,841 114,096 Deferred tax assets 103,073 81,440 Non-current inventory and other 9,831 9,101 Total assets $ 601,140 $ 656,204 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 47,619 $ 39,086 Product revenue allowances 70,251 60,895 Total current liabilities 117,870 99,981 Operating lease non-current liabilities 3,419 4,944 Finance lease non-current liabilities 2,808 3,146 Other non-current liabilities 11,044 9,587 Total liabilities 135,141 117,658 Stockholders' equity: Common stock 59 58 Additional paid-in capital 718,979 712,706 Accumulated other comprehensive income 540 74 Accumulated deficit (253,579) (174,292) Total stockholders' equity 465,999 538,546 Total liabilities and stockholders' equity $ 601,140 $ 656,204 Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21 % more press release views with Request a Demo × Modal title