Topiramate

Total revenues were $207.7 million in the first quarter 2026, a 39% increase compared to same period last year. Combined revenues of the Company's four growth products increased to $149.1 million in the first quarter 2026, representing an increase of 56% compared to the same period last year. This strong growth was driven by an increase in net sales of Qelbree® and GOCOVRI®, and the addition of sales from ZURZUVAE® and ONAPGO™. Regulatory submission to the FDA for second supplier for ONAPGO expected in third quarter 2026, with potential approval by mid-year 2027. The Company reiterates full year 2026 financial guidance. ROCKVILLE, Md. , May 05, 2026 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the first quarter 2026 and associated Company developments. “Our first quarter results reflect a strong start to the year, including a 56% year-over-year increase in combined revenues of our growth products,” said Jack Khattar , President and CEO of Supernus. “We have positive momentum across our business, and I look forward to continued strong growth and execution of our key products throughout the year.” Commercial Highlights ONAPGO net product sales were $8.4 million in the first quarter of 2026, reflecting resumption of new patient initiation in February 2026 . Since the launch in April 2025 , and through the end of April 2026 , approximately 2,200 enrollment forms have been submitted by more than 645 prescribers. The Company expects to file a regulatory submission to the U.S. Food and Drug Administration (FDA) for a second supplier for ONAPGO in the third quarter of 2026, with potential FDA approval for the second supplier by mid-year 2027. Collaboration revenue from ZURZUVAE was $27.6 million in the first quarter of 2026. Collaboration revenue represents 50% of the net revenues for ZURZUVAE recorded by Biogen Inc. First quarter 2026 U.S sales of ZURZUVAE, as reported by Biogen Inc., increased approximately 100% compared to the same period in 2025. The total number of prescriptions for ZURZUVAE increased by 82% in the first quarter of 2026 compared to the same period last year. Net sales of Qelbree increased 20% to $77.9 million in the first quarter of 2026, compared to the same period in 2025, driven primarily by volume growth. Total IQVIA prescriptions(6) for Qelbree were 254,824 for the first quarter 2026, representing an increase of 19% compared to the same period last year. The total number of prescribers reached an all-time high of approximately 43,000 in the first quarter of 2026. Net sales of GOCOVRI increased 15% to $35.2 million in the first quarter of 2026, compared to the same period in 2025. Total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year. Product Pipeline Update SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures. SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression The Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms. SPN-443 – Novel stimulant for attention-deficit/hyperactivity disorder (ADHD) The Company expects to initiate a Phase 1 single-ascending/multiple-ascending dose study in adult healthy volunteers in the second half of 2026. Financial Highlights This section includes information on non-GAAP financial measures. See "Non-GAAP Financial Information" section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release. Revenues The following table provides information regarding total revenues (dollars in millions): Total revenues from commercial products (non-GAAP)(1)(4) represent revenues from our product sales to customers and through our collaboration agreement with Biogen. Other Financial Highlights The Company recognized $20.0 million of licensing revenue in the first quarter of 2026 related to the achievement of a commercial milestone under its collaboration agreement with Shionogi. Operating loss was $8.3 million for the first quarter of 2026, compared to an operating loss of $10.3 million for the same period in 2025. The change was primarily due to higher revenues and a lower change in contingent consideration loss in the 2026 period, partially offset by an increase in selling, general, and administrative expenses associated with the collaboration agreement with Biogen Inc., an increase in research and development costs related to clinical program costs on SPN-817, which includes a $10.0 million expense to former Biscayne security holders, and an increase in intangible asset amortization expense for ZURZUVAE and ONAPGO intangible assets in 2026. Adjusted operating earnings (non-GAAP)(1) were $28.7 million in the first quarter of 2026, compared to $25.9 million for the same period in 2025. Net loss and diluted loss per share were $2.3 million and $0.04 for the first quarter of 2026, respectively, compared to net loss and diluted loss per share of $11.8 million and $0.21 for the same period in 2025. Cash, cash equivalents, and current marketable securities were approximately $384.2 million as of March 31, 2026 , compared to $308.7 million as of December 31, 2025 . This increase was primarily due to cash generated from operations and the aforementioned commercial milestone. Full Year 2026 Financial Guidance For the full year 2026, the Company reiterates its full year financial guidance as set forth below (dollars in millions): Non-GAAP Financial Information This press release contains financial measures that present financial information which do not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP adjusted operating earnings on a historical and projected basis adjusts for non-cash share-based compensation expense, depreciation and amortization, intangible asset impairment charges and changes to fair value of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and excludes those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We also present total revenues excluding net sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated as total revenues (GAAP) less net product sales of Trokendi XR (GAAP) and Oxtellar XR (GAAP). Beginning in the year a product loses exclusivity due to generic entrants, we generally do not expect net product sales of such products to constitute a significant part of our revenue in the future. We also present total revenues from commercial products, which is also a non-GAAP measure and is calculated as the combined total of total net product sales (GAAP) and collaboration revenues (GAAP). We believe that the use of non-GAAP financial measures provides useful supplemental information to management, investors, analysts and others regarding the Company's revenue and results of operations and assist management, investors, analysts, and others in understanding and evaluating our revenue growth and the performance of the business. There are limitations associated with the use of non-GAAP financial measures and therefore comparability may be limited. These limitations include: non-GAAP financial measures that may not be entirely comparable to similarly titled measures used by other companies; these may not reflect all items of income and expense, as applicable, that affect our operations; there may be potential differences among calculation methodologies; these may differ from the non-GAAP information used by other companies, including peer companies. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company's 2026 financial guidance is also being provided on both a GAAP and a non-GAAP basis. End Notes__________________________(1) See the section titled "Non-GAAP Financial Information" for information about this non-GAAP financial measure. A reconciliation of each non-GAAP financial measure to the most directly comparable GAAP financial measure is included at the end of this press release.(2) Includes net product sales of MYOBLOC®, XADAGO® and Osmolex ER®.(3) Represents proportionate share of collaboration revenue from Biogen’s sales of ZURZUVAE to customers in the U.S. from July 31, 2025 , the closing of the acquisition of Sage Therapeutics, Inc. (4) Total revenues from commercial products, a non-GAAP measure, represents revenues from our product sales to customers and through our collaboration agreement with Biogen. (5) Royalty, licensing, and other revenues include royalties on generic Trokendi XR, Oxtellar XR, other licensed products and intellectual property.(6) IQVIA data restatement July 1, 2025 .(7) Includes net product sales, collaboration revenue, and royalty, licensing, and other revenue. Conference Call Details Supernus will host a conference call and webcast today, May 5, 2026 , at 4:30 p.m. Eastern Time to discuss these results. A live webcast will be available in the Events & Presentations section of the Company's Investor Relations website www.supernus.com/Investors. Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time. Following the live call, a replay will be available on the Company's Investor Relations website www.supernus.com/Investors. The webcast will be available on the Company's website for 60 days following the live call. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson's disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, postpartum depression (PPD), epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel product candidates for CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's ability to increase the number of prescriptions written for each of its products, and the products of its subsidiaries; the Company's ability to increase its net revenue from its products, and the products of its subsidiaries; the Company's ability to commercialize its products, and the products of its subsidiaries; the Company's ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; the Company's ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates; the Company's projected markets and growth in markets; the Company's product formulations and patient needs and potential funding sources; the Company's staffing needs; changes to laws and regulations applicable to our industry, the impact of macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events. __________________________(a) Excludes amortization of intangible assets. Reconciliation of GAAP Total revenues to Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net sales An itemized reconciliation between total revenues on a GAAP basis and total revenues excluding Trokendi XR and Oxtellar XR net sales, a non-GAAP measure, is as follows (dollars in millions): __________________________(a) Includes net product sales, collaboration revenue, and royalty, licensing, and other revenues. Reconciliation of GAAP Net Product Sales to Non-GAAP Revenues from Commercial Products An itemized reconciliation between Net product sales on a GAAP basis and total revenues from commercial products, a non-GAAP measure, is as follows (dollars in millions): Total revenues from commercial products, a non-GAAP measure, represents revenues from our product sales to customers and through our collaboration agreement with Biogen. Reconciliation of GAAP Operating Earnings (Loss) to Non-GAAP Adjusted Operating Earnings An itemized reconciliation between operating earnings (loss) on a GAAP basis and adjusted operating earnings on a non-GAAP basis is as follows (dollars in millions): __________________________ Non-GAAP adjusted operating earnings adjusts for non-cash items, which include amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Reconciliation of Full Year 2026 Financial Guidance - GAAP Operating Earnings to Non-GAAP Adjusted Operating Earnings An itemized reconciliation between projected operating earnings on a GAAP basis for the full year 2026 and projected adjusted operating earnings on a non-GAAP basis for the full year 2026 is as follows (dollars in millions): CONTACTS: Jack A. Khattar , President and CEO Timothy C. Dec , Senior Vice President and CFO Supernus Pharmaceuticals, Inc. (301) 838-2591 or INVESTOR CONTACT: Peter Vozzo ICR Healthcare (443) 213-0505peter.vozzo@icrhealthcare.com Source: Supernus Pharmaceuticals, Inc.

对于饱受折磨的偏头痛患者，这不仅是止痛，更是夺回被疾病偷走的时间。 “下个月还要打针吗？” “要打，但你这个月只发作了3次，上个月是11次。” 在神经内科门诊，这样的对话正变得越来越常见。对于数百万中国偏头痛患者而言，传统的“头痛医头”模式正在被颠覆。根据2023年《中国偏头痛诊断与治疗指南》，一类名为“抗CGRP单抗”的精准靶向药物，已将偏头痛的预防性治疗带入了“每月一剂”的精准时代。 临床数据显示，这类药物能将患者的 每月偏头痛天数降低约50%-60% ，部分患者甚至实现零发作。这不仅仅是减少几次疼痛，更是将患者从“每月少活7-15天”的残疾状态中解救出来。 一、 为什么偏头痛需要“预防”而非仅仅“止痛”？ 偏头痛的本质并非简单的“头痛”，而是一种 慢性神经血管功能障碍性疾病 。在发作时，患者大脑中的降钙素基因相关肽（CGRP）水平会急剧升高，导致脑血管异常扩张、三叉神经炎症，引发剧烈疼痛。 1. 止痛药的陷阱 大多数患者依赖布洛芬、曲普坦类等急性止痛药。然而，若每月使用超过10天，极易引发 药物过度使用性头痛（MOH） ，导致头痛慢性化、更难治疗。这形成了一个恶性循环：越痛越吃，越吃越痛。 2. 预防性治疗的目标 预防性治疗的核心目标是 降低发作频率和严重程度 。传统的预防药物如普萘洛尔、托吡酯、氟桂利嗪等，虽然有效，但往往伴随嗜睡、体重增加、认知迟钝等副作用，导致患者依从性差，难以长期坚持。 二、 抗CGRP单抗：如何实现“每月一针”控头痛？ 抗CGRP单抗是一类生物制剂，它不像传统药物那样广泛作用于全身，而是像“精确制导导弹”一样，专门中和导致偏头痛的关键因子——CGRP或其受体。 1. 作用机制：从“乱枪打鸟”到“精准狙击” CGRP是偏头痛发作通路上的“最后共同通路”的关键信使。抗CGRP单抗通过皮下注射进入体内后，会与CGRP结合，阻止其与受体结合，从而从源头上阻断疼痛信号的传导。由于抗体在体内的代谢周期长，一次注射可维持血药浓度约4周，因此实现了“每月一剂”的给药频率。 2. 核心优势：高依从性与低副作用 依从性高 ：一年仅需注射12次，相比每天口服药物，漏服率大幅下降。 副作用少 ：由于靶点精准，不干扰全身其他生理功能，最常见的不良反应仅为轻度的注射部位反应（红、肿），严重副作用罕见，耐受性显著优于传统口服药。 三、 具体药物清单：四种已获指南推荐的“利器” 根据中国国家药监局（NMPA）批准情况及中华医学会神经病学分会指南，目前可用于预防性治疗的抗CGRP单抗主要包括以下四种（均为处方药，需在医生指导下使用）： 药物通用名 商品名（示例） 靶点 中国获批/指南推荐情况 用法用量（成人） 加卡奈珠单抗 (Galcanezumab) 恩加乐® (Emgality) CGRP配体 已获批，2024指南推荐 首月 ：240mg（120mg×2针）， 后续 ：每月120mg 皮下注射 瑞玛奈珠单抗 (Fremanezumab) Ajovy® CGRP配体 指南Ⅱ级推荐（A级证据） 月方案 ：225mg/月； 季方案 ：675mg/3个月 皮下注射 依瑞奈尤单抗 (Erenumab) 益安妥® (Aimovig) CGRP受体 指南Ⅱ级推荐（A级证据） 70mg/月，效果不佳可增至140mg/月 皮下注射 艾普奈珠单抗 (Eptinezumab) Vyepti® CGRP配体 指南推荐 100mg/季度， 静脉输注 （非皮下注射） 注 ：具体用药选择需由神经内科医生根据患者发作频率（发作性/慢性）、既往治疗史及合并症决定。 四、 真实疗效数据：能减少多少发作天数？ 多项针对中国人群的III期临床研究（如DRAGON研究、CGAX研究）证实了其显著疗效： 1. 发作性偏头痛（EM） 加卡奈珠单抗（Galcanezumab） ：治疗3个月后，每月偏头痛天数较基线平均减少约 4-5天 ，超过50%的患者发作天数减少一半以上。 依瑞奈尤单抗（Erenumab） ：在亚洲人群研究中，每月偏头痛天数较安慰剂组多减少约 2.5-3天 。 2. 慢性偏头痛（CM，每月头痛≥15天） 瑞玛奈珠单抗（Fremanezumab） ：治疗12周时，每月偏头痛天数平均减少约 4.6天 （安慰剂组仅减少2.8天），且起效迅速，部分患者在第1周即感受到改善。 依瑞奈尤单抗 ：在DRAGON研究中，慢性偏头痛患者每月偏头痛天数较基线减少约 8.19天 ，残疾程度显著降低。 五、 谁适合使用？并非所有头痛都需要“上生物制剂” 抗CGRP单抗虽好，但价格相对昂贵（尽管部分药物已进入医保谈判或地方医保），因此指南建议优先用于以下人群： 中重度患者 ：每月偏头痛天数≥4天，且严重影响生活、工作或学习。 传统治疗失败者 ：尝试过至少2-3种传统口服预防药物（如普萘洛尔、托吡酯）但疗效不佳或不耐受其副作用。 药物过度使用风险高者 ：无法控制急性止痛药用量，有转为慢性头痛风险的患者。 禁忌与筛查 ：用药前需排除妊娠、哺乳期女性；需筛查活动性感染、严重心血管疾病及对生物制剂成分过敏者。 抗CGRP单抗的出现，标志着偏头痛治疗从“发作后补救”进入了“发作前阻断”的精准医学时代。对于河南驻马店及全国的患者而言，这意味着： 时间赎回 ：每月多出5-8个无痛日，相当于每年多出2-3个月的正常生活。 生活质量跃升 ：不再因担心头痛而拒绝社交、旅行或重要工作。 给患者的建议 ： 记录头痛日记 ：详细记录发作日期、时长、诱因，这是医生判断是否需升级治疗的关键依据。 寻求专业评估 ：前往设有头痛专病门诊的医院神经内科，由医生评估是否适合使用生物制剂。 关注医保政策 ：随着2024年国家医保目录调整，部分药物（如加卡奈珠单抗）的可及性正在提高，可咨询当地医保局报销政策。 偏头痛不再是必须“硬扛”的宿命。在精准靶向药物的护航下，每月一针，或许就是你重获生活掌控权的开始。 参考文献 ： 中华医学会神经病学分会头痛协作组. 中国偏头痛诊断与治疗指南（第一版）[J]. 中华神经科杂志, 2023. DRAGON Study: Erenumab in Asian patients with chronic migraine. Cephalalgia. 2022. CGAX Study: Galcanezumab in predominantly Chinese patients with episodic migraine. Headache. 2021. Teva's fremanezumab phase III data in Chinese patients. Neurology supplement. 2024. （注：本文提及药物均为处方药，需在神经内科医生指导下使用；具体报销政策以各地医保局最新公布为准）