Ponesimod

Full year 2025 Fanapt® net product sales increased by 24% to $117.3 million compared to full year 2024 Full year 2025 total revenues increased by 9% to $216.1 million compared to full year 2024 NEREUS™ (tradipitant) approved for the prevention of vomiting induced by motion Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 WASHINGTON, Feb. 11, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2025. "2025 showed strong momentum at Vanda, led by Fanapt, with net product sales up 24% to $117.3 million, driven by a 28% rise in total prescriptions and 149% surge in new-to-brand prescriptions - reflecting accelerating growth in schizophrenia and bipolar I disorder. We await the FDA decision on the Bysanti (milsaperidone) NDA by the February 21, 2026 PDUFA date, which would expand our psychiatry franchise in the global antipsychotic category. This category had a total addressable market estimated at approximately $20 billion in 2025," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "The FDA approval of NEREUS (tradipitant) is a landmark - the first new oral therapy for motion-induced vomiting prevention in over 40 years - targeting a large addressable population of roughly 65–78 million U.S. adults experiencing symptoms, with tens of millions seeking relief annually. We are preparing for the NEREUS commercial launch and plan to start a Phase III program in the first half of 2026 for its use in preventing vomiting from GLP-1 analogs," continued Dr. Polymeropoulos. "We submitted the imsidolimab BLA in Q4 2025 for generalized pustular psoriasis, a rare orphan condition. With our current franchise - Fanapt, HETLIOZ, HETLIOZ LQ, and PONVORY - we expect 2026 total revenues of $230 to $260 million from these marketed products alone, providing a solid baseline. We look forward to continued growth from this portfolio, with further contributions from the NEREUS launch and potential approvals of Bysanti and imsidolimab." Financial Highlights Fourth Quarter of 2025 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $57.2 million in the fourth quarter of 2025, an 8% increase compared to $53.2 million in the fourth quarter of 2024. Fanapt® net product sales were $33.2 million in the fourth quarter of 2025, a 25% increase compared to $26.6 million in the fourth quarter of 2024. HETLIOZ® net product sales were $16.4 million in the fourth quarter of 2025, an 18% decrease compared to $20.0 million in the fourth quarter of 2024. PONVORY® net product sales were $7.6 million in the fourth quarter of 2025, a 17% increase compared to $6.5 million in the fourth quarter of 2024. Loss before income taxes was $38.0 million in the fourth quarter of 2025 compared to a loss before income taxes of $6.5 million in the fourth quarter of 2024. Provision for income taxes was $103.2 million in the fourth quarter of 2025 compared to a benefit for income taxes of $1.6 million in the fourth quarter of 2024. The provision for income taxes in the fourth quarter of 2025 includes the impact of the recording of a valuation allowance of $113.7 million against all of Vanda's deferred tax assets, which is a non-cash charge. Cash, cash equivalents and marketable securities (Cash) was $263.8 million as of December 31, 2025, representing a decrease to Cash of $29.9 million compared to September 30, 2025. Full Year 2025 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $216.1 million for the full year 2025, a 9% increase compared to $198.8 million for the full year 2024. Fanapt® net product sales were $117.3 million for the full year 2025, a 24% increase compared to $94.3 million for the full year 2024. HETLIOZ® net product sales were $71.4 million for the full year 2025, a 7% decrease compared to $76.7 million for the full year 2024. PONVORY® net product sales were $27.4 million for the full year 2025, a 2% decrease compared to $27.8 million for the full year 2024. Loss before income taxes was $138.6 million for the full year 2025 compared to a loss before income taxes of $22.9 million for the full year 2024. Provision for income taxes was $81.8 million for the full year 2025 compared to a benefit for income taxes of $4.0 million for the full year 2024. The provision for income taxes for the full year 2025 includes the impact of the recording of a valuation allowance of $113.7 million against all of Vanda's deferred tax assets, which is a non-cash charge. Cash was $263.8 million as of December 31, 2025, representing a decrease to Cash of $110.8 million compared to December 31, 2024. Key Operational Highlights – Commercial Fanapt® experienced significant growth, with total prescriptions (TRx)1 increasing by 36% and Fanapt® net product sales increasing by 25% in the fourth quarter of 2025 as compared to the fourth quarter of 2024. Fanapt® total prescriptions increased by 28% and Fanapt® net product sales increased by 24% for the full year 2025 as compared to the full year 2024. New to brand prescriptions (NBRx)1 increased by 108% in the fourth quarter of 2025 as compared to the fourth quarter of 2024 and increased by 149% for the full year 2025 as compared to the full year 2024. During 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. Fanapt® performance remains the focus of Vanda's commercial initiatives and encourages us to continue to invest in this differentiated medicine, and, if approved, the franchise-extending launch of Bysanti™. Key Operational Highlights – Regulatory & Clinical Development The U.S. Food and Drug Administration (FDA) has approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. Bysanti™ (milsaperidone) New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026. 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. Vanda announced positive results of a clinical study of NEREUSTM in the prevention of vomiting induced by a GLP-1 analog, Wegovy® (semaglutide). A Phase III clinical program is anticipated to be initiated in the first half of 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) was submitted to the FDA in the fourth quarter of 2025. A Phase III study of VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, in the treatment of adults with social anxiety disorder has been initiated and study results are expected by the end of 2026. The Phase III study of the long acting injectable (LAI) formulation of iloperidone in the treatment of schizophrenia in relapse-prevention is enrolling patients. A clinical study of the LAI formulation of iloperidone in people with treatment-resistant hypertension is ongoing and Vanda is enrolling patients. On January 8, 2026, Vanda announced that it had received a decision letter from the FDA Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in the current form. This letter followed CDER's re-review of the jet lag sNDA under Vanda's collaborative framework agreement with the FDA. Vanda has requested that the FDA Commissioner resume hearing proceedings. GAAP Financial Results Net loss was $141.2 million in the fourth quarter of 2025 compared to net loss of $4.9 million in the fourth quarter of 2024. Diluted net loss per share was $2.39 in the fourth quarter of 2025 compared to diluted net loss per share of $0.08 in the fourth quarter of 2024. Net loss was $220.5 million for the full year 2025 compared to net loss of $18.9 million for the full year 2024. Diluted net loss per share was $3.74 for the full year 2025 compared to diluted net loss per share of $0.33 for the full year 2024. Provision for Income Taxes - One-Time, Non-Cash Charge Impact In the fourth quarter of 2025, Vanda determined that it is not more-likely-than-not that it will realize its existing net deferred tax assets, having reviewed both positive and negative evidence as well as expectations of future taxable income, and recorded a valuation allowance against all its deferred tax assets. As a result, the fourth quarter of 2025 provision for income taxes includes a one-time, non-cash income tax charge of $113.7 million. Excluding this one-time non-cash tax charge, our full year 2025: Effective tax rate would have increased to 23%, compared to the reported effective tax rate of negative 59%. Net loss would have decreased to $106.8 million, compared to the reported net loss of $220.5 million. Diluted net loss per share would have decreased to $1.81, compared to the reported diluted net loss per share of $3.74. Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information." 2026 Financial Guidance Due to the recent and upcoming regulatory and commercial milestones, Vanda's 2026 financial guidance is limited to revenue guidance for currently commercialized products which includes Fanapt®, HETLIOZ® and PONVORY®. Vanda expects to achieve the following financial objectives in 2026. Conference Call Vanda has scheduled a conference call for today, Wednesday, February 11, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 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, February 11, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, February 18, 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 8728050. The conference call will be broadcast simultaneously on Vanda's website, . 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 Non-GAAP Financial Information Vanda believes that the above Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda's business and reflect how it manages the business internally and sets operational goals. The Non-GAAP effective tax rate, Non-GAAP net loss and Non-GAAP dilutive EPS exclude the one-time, non-cash valuation allowance income tax charge. Vanda believes that excluding the impact of this one-time, non-cash charge better reflects the recurring economic characteristics of its business, as well as Vanda's use of financial resources and its long-term performance. These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies because all companies may not calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies. The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda's financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial information in connection with its GAAP financial information. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure. 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 and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of BysantiTM for the treatments of bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines and prospects for approval; Vanda's commercial launch plans for NEREUSTM for the prevention of vomiting induced by motion; the prevalence of motion-induced vomiting in the U.S. and the number of people seeking relief each year; the goals, focus and expected results of Vanda's commercial infrastructure investment strategy; Vanda's clinical development plans and expected timelines for BysantiTM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by Wegovy®, the long acting injectable formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension and VQW-765 in the treatment of adults with social anxiety disorder; Vanda's plans to continue its pursuit of FDA approval of HETLIOZ® for the treatment of jet lag disorder; and Vanda's expectations with respect to the strength of its business are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDA for Bysanti™ by February 21, 2026; Vanda's ability to obtain regulatory approval of imsidolimab for the treatment of GPP; Vanda's ability to successfully execute the commercial launch of NEREUSTM; the accuracy of the estimates of the prevalence of motion-induced vomiting in the U.S. and the number of people seeking relief each year; 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 study for BysantiTM for the treatment of MDD and receive results in 2026; Vanda's ability to initiate the clinical program for NEREUSTM in the prevention of vomiting induced by Wegovy® in the first half of 2026; Vanda's ability to complete enrollment of patients in the clinical studies for the LAI formulation of iloperidone in the treatments of schizophrenia in relapse-prevention and hypertension; Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 2026; and the FDA's willingness to resume hearing proceedings on 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 . 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. 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

药品详细信息 一、基本信息 药品名称：NEREUS™（活性成分：tradipitant），为口服胶囊。 首次美国批准时间：2025年。 作用机制：选择性、高亲和力的人P物质/神经激肽-1（NK-1）受体拮抗剂，可抑制NK-1受体及P物质诱导的细胞内钙动员；动物模型显示抑制药物诱导的呕吐，人体PET研究证实其可透过血脑屏障并占据脑内NK-1受体。 二、适应症 用于预防成人运动引起的呕吐。 三、用法用量 推荐剂量：单次口服85 mg或170 mg，约在预期引发运动性呕吐事件前60分钟服用；优先使用最低有效剂量。 24小时最大剂量：单剂量85 mg或170 mg（未超过90次的安全性未确立）。 给药条件：空腹服用（至少饭前1小时或饭后2小时）。 四、剂型与规格 胶囊：85 mg（白色不透明胶囊体，黑色不透明帽上印“VANDA 85mg”白色字样）。 包装：36粒/瓶（HDPE瓶，带儿童安全盖和干燥剂），NDC 43068-585-02。 五、禁忌症 无明确禁忌症。 六、警告与注意事项 驾驶与操作机械能力影响：可能引起嗜睡和/或疲劳，损害驾驶或操作重型机械所需的身心能力；联用其他中枢神经抑制药物或强CYP3A4抑制剂可能加重此效应。若必须联用，需警告患者避免驾驶及需高度警觉的活动。 七、不良反应 最常见（发生率≥5%）：嗜睡、头痛、疲劳。 临床试验数据（85 mg vs 安慰剂；170 mg vs 安慰剂）： 嗜睡：6%（85 mg）、12%（170 mg）vs 4%（85 mg安慰剂）、6%（170 mg安慰剂）； 头痛：7%（85 mg）、10%（170 mg）vs 5%（85 mg安慰剂）、6%（170 mg安慰剂）； 疲劳：6%（85 mg）、8%（170 mg）vs 3%（85 mg安慰剂）、2%（170 mg安慰剂）。 八、药物相互作用 强CYP3A4抑制剂：可能增加tradipitant暴露量，升高不良反应风险（tradipitant为CYP3A4底物）。 九、特殊人群用药 妊娠：现有临床数据不足以评估胎儿风险；动物研究显示器官发生至哺乳期或兔器官发生期间给药无发育毒性（暴露量为MRHD的3.3倍或1.4倍）。 哺乳期：大鼠乳汁中检出tradipitant（幼崽血药浓度为母体的1%-3%），需监测母乳喂养婴儿的嗜睡情况。 儿科：安全性与有效性未确立。 老年：65岁及以上受试者占对照试验的13%，未观察到与年轻成人的安全性或有效性差异，但部分老年人可能更敏感。 肾损伤：轻中度（eGFR≥30 mL/min/1.73m²）无需调整剂量；重度（eGFR≤29 mL/min/1.73m²）避免使用。 肝损伤：任何程度肝损伤（Child-Pugh A-C级）均未研究，避免使用。 十、药代动力学 吸收：空腹下，85 mg的Cmax为84.7 ng/mL，AUC0-inf为1839 ng·h/mL，Tmax中位数为2.0小时；170 mg的Cmax为112 ng/mL，AUC0-inf为3526 ng·h/mL，Tmax为1.5小时。 食物影响：高脂饮食显著增加暴露（85 mg时Cmax↑4.7倍，AUC↑2.4倍；170 mg时Cmax↑6.9倍，AUC↑2.9倍），延迟Tmax 2-2.5小时。 分布：表观分布容积（Vd/F）1956 L，血浆蛋白结合率96%-＞99%。 消除：半衰期约34小时，表观清除率41.7 L/h；88%经粪便排泄（原形极少），7%经尿液（未检出原形）。 十一、临床研究 有效性：两项随机双盲安慰剂对照研究（Study 1、2）显示，85 mg和170 mg分别降低呕吐发生率25%-26%和19%-27%（vs 安慰剂）。 次要终点：恶心评分无统计学显著差异。 十二、储存与处理 室温（25°C，允许15-30°C）保存，避光防潮。 十三、患者咨询要点 告知可能的嗜睡/疲劳及对驾驶的影响，避免联用中枢抑制药物； 强调服药时间（事件前60分钟）、空腹要求及24小时最大剂量； 哺乳期女性需监测婴儿嗜睡情况。 研发公司概况 Vanda Pharmaceuticals Inc.（NASDAQ: VNDA）是一家总部位于美国华盛顿特区的全球性生物制药公司，成立于2002年。公司专注于发现、开发和商业化满足中枢神经系统、睡眠医学和炎症性疾病等领域重大未愈医疗需求的创新疗法，并于2006年在纳斯达克上市。 公司核心业务围绕其已上市产品组合展开，主要包括用于治疗睡眠-觉醒周期障碍的Hetlioz®、用于治疗精神分裂症等疾病的Fanapt®，以及用于治疗复发性多发性硬化症的Ponvory®。 财务方面，公司预计2025年总收入在2.1亿至2.3亿美元之间。尽管近年因持续的研发投入处于净亏损状态，但其保持着高毛利率和稳健的现金状况，预计2025年末现金余额可达2.6亿至2.9亿美元，为未来运营和研发提供了有力支持。 研发是公司发展的核心驱动力。其关键研发管线包括：用于治疗晕动病的Tradipitant（其新药申请正接受FDA审评，目标决定日期为2025年12月30日）、用于治疗罕见皮肤病的抗体药物 Imsidolimab（计划2025年内提交上市申请），以及用于治疗精神分裂症等疾病的 Bysanti™（预计2026年初获得FDA审评决定）。近期，公司成功解决了与美国食品药品监督管理局的多项关键监管争议，为这几款重要药物的审评推进扫清了障碍。 总的来说，Vanda是一家拥有成熟产品、稳健财务和清晰研发管线的生物技术公司，正致力于通过创新疗法改善患者生活。