Pimavanserin tartrate

一、开场介绍会议时间：2026年第四季度主持人说明：由加拿大皇家银行资本市场分析师内文·奇特尔主持，介绍参会人员（研发部负责人伊丽莎白·H.Z.·汤普森、首席商务官托马斯·加纳等），会议目的为讨论公司药物研发进展（如remlofanserin）及商业业务（Neuplazid、Debut）情况。管理层发言摘要：伊丽莎白·H.Z.·汤普森（研发部负责人）：重点介绍remlofanserin的临床前优势及试验策略，强调从Pimavanserin项目中吸取的经验对当前研发的指导意义。托马斯·加纳（首席商务官）：阐述Neuplazid销售团队扩张后的市场表现及Debut在社区中心的拓展策略，提及DebutStix剂型推出的初步反馈。二、财务业绩分析核心财务数据暂无信息关键驱动因素暂无信息三、业务运营情况分业务线表现Neuplazid：2026年第一季度销售团队覆盖范围增加约30%，核心客户仍以神经科医生为主（占比45%）；第一季度新品牌处方者占总处方者的25%，团队培训完成后预计下半年销量增长效应更明显。Debut：患者持续率提升，12个月持续率超55%，18个月约50%；社区中心拓展取得进展，非卓越中心患者占比约三分之二，当前渗透率接近20%，增长空间较大。市场拓展Debut社区覆盖：从聚焦卓越中心转向社区中心，触达更多非卓越中心患者，通过家庭支持教育者团队与停药患者重新接触，推动回归用药。欧盟市场：Debut数据重新分析已提交CHMP，重新审查过程预计2026年6月底结束，涉及科学咨询小组（SAG）会议及口头审查等环节。研发投入与成果remlofanserin（ADp治疗）：新一代药物，相比Pimavanserin消除QTC间期延长问题，可提高剂量和暴露量（60mg剂量暴露量为Pimavanserin的2倍），半衰期更短（老年人5-6天达稳态，Pimavanserin需12-15天）；二期试验采用生物标志物确认AD诊断，严格培训研究人员以降低安慰剂反应，检验效能80%（针对科恩D效应量0.4）。ACP271（GPR88激动剂）：非临床数据显示可改善运动障碍及神经精神症状，无已批准疗法常见的镇静、抑郁等副作用，一期试验将评估安全性及靶点验证。运营效率Neuplazid销售团队：第一季度中期完成实地培训，团队正熟悉新目标客户，预计6-9个月内实现效率提升。Debut剂型优化：推出DebutStix（粉末剂型，便携、无需冷藏，去除特定辅料），适用于生酮饮食患者，初步需求积极，30%初次及回归患者已开始使用，患者回归率提升。四、未来展望及规划短期目标（2026年）Neuplazid：推动销售团队扩张后的处方增长，预计下半年销量增长效应显现。Debut：扩大DebutStix推广，提升社区中心渗透率，利用新剂型促进患者依从性及回归用药；关注欧盟CHMP重新审查结果（6月底结束）。研发：基于remlofanserin二期试验数据优化Enrich三期试验设计，控制效应量衰减风险。中长期战略杠铃策略：持续投资神经科和罕见病领域，引入未来几年内可能上市的后期阶段产品，同时通过中期管线补充早期阶段资产（如ACP271）。研发方向：聚焦ADp、运动障碍等领域，利用生物标志物和临床经验提升药物研发成功率。五、问答环节要点remlofanserin研发策略问：remlofanserin与Pimavanserin的临床前差异及试验设计如何提升疗效？答：核心差异为消除QTC间期延长，可提高剂量和暴露量；试验通过生物标志物确认AD诊断、纳入严重精神病患者、使用敏感终点（SAPSH&D）以降低安慰剂反应，预计更高暴露量带来更好疗效。Neuplazid商业表现问：销售团队扩张后的处方增长指标及第一季度处方延迟原因？答：新品牌处方者占比25%，团队培训后下半年效应更明显；处方延迟主要因Medicare患者1月计划重置，预计不影响后续季度。Debut市场与剂型问：社区中心与专科中心的患者持续率差异及DebutStix反馈？答：社区与专科中心持续率曲线趋缓（12个月超55%）；Stix因便携、无需冷藏及辅料优化获积极反馈，30%患者使用，推动停药患者回归。欧盟Debut审批问：CHMP重新审查的时间线？答：预计2026年6月底结束，涉及报告员指定、重新审查理由提交及SAG会议等环节。ACP271项目风险问：GPR88激动剂的风险降低程度及一期试验目标？答：非临床数据显示改善运动障碍且无镇静副作用，一期试验将验证安全性及靶点相关性。公司战略方向问：杠铃策略是否持续？答：坚持杠铃策略，投资神经科和罕见病，平衡后期产品上市与早期管线布局。六、总结发言管理层强调将继续执行“杠铃策略”，聚焦神经科和罕见病领域，通过后期阶段产品上市与早期管线资产补充驱动增长；研发方面，remlofanserin二期试验数据将指导三期优化，ACP271等早期项目有望拓展治疗领域；商业方面，Neuplazid销售团队扩张和DebutStix推广将推动市场渗透，欧盟市场审批进展值得关注。查看业绩会议全文

- First quarter DAYBUE ® GAAP net sales of $101 million, up 20% year-over-year; successful launch of DAYBUE STIX underway - First quarter NUPLAZID ® GAAP net sales of $167 million, up 6% year-over-year on a non-GAAP adjusted basis - Reaffirms expectation for topline results from the Phase 2 remlifanserin study in Alzheimer’s disease psychosis between August and October 2026 SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the first quarter ended March 31, 2026. “Acadia delivered a solid first quarter of 2026 with total revenues of $268 million, driven by a strong start from DAYBUE, which generated sales of $101 million,” said Catherine Owen Adams, Chief Executive Officer. “We are very encouraged by the early enthusiasm for DAYBUE STIX, which is now broadly available in the U.S., and by the initial uptake during our focused launch. NUPLAZID generated sales of $167 million, supported by strong new referrals and underlying demand, with performance strengthening as the quarter progressed. As we look ahead, we remain focused on advancing our deep, differentiated pipeline, with remlifanserin representing a key value driver as we approach expected Phase 2 topline data in Alzheimer’s disease psychosis later this year. We are reaffirming our full year guidance and remain confident in our ability to deliver long‑term value for both patients and shareholders.” Company Updates Full launch of DAYBUE STIX (trofinetide) in the U.S. is underway, with ~30% of STIX patients being either treatment-naive or returning after previously discontinuing the liquid formulation. Phase 2 topline results readout from the remlifanserin Alzheimer’s disease psychosis study remains on track for August to October 2026 timeframe. Accelerated enrollment in the trofinetide clinical trial in Japan, with topline results now anticipated in the September to November 2026 timeframe. Delphi expert consensus panel recently recommended DAYBUE as part of the standard of care for eligible patients with Rett syndrome. 1 Financial Results Revenues GAAP total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $268 million for the first quarter of 2026, up 10% as compared to GAAP total revenues of $244 million in the first quarter of 2025, and up 11% as compared to non-GAAP adjusted total revenues of $242 million in the first quarter of 2025. GAAP net product sales of NUPLAZID were $167 million for the first quarter of 2026, up 5% compared to GAAP net product sales of $160 million for the first quarter of 2025, and up 6% as compared to non-GAAP adjusted net product sales of $157 million for the first quarter of 2025. Net product sales of DAYBUE were $101 million for the first quarter of 2026, an increase of 20% as compared to $85 million for the first quarter of 2025. A reconciliation of NUPLAZID non‑GAAP adjusted net sales and non‑GAAP adjusted total revenues is provided in Table 1. A description of these adjustments is included under ‘Non-GAAP Financial Measures.’ Research and Development Research and development expenses for the first quarter of 2026 were $77 million, compared to $78 million for the same period of 2025. Selling, General and Administrative Selling, general and administrative expenses for the first quarter of 2026 were $171 million, compared to $126 million for the same period of 2025. The increase in selling, general and administrative expenses during the first quarter was primarily driven by increased investments to support continued growth of NUPLAZID and DAYBUE. Net Income For the first quarter of 2026, Acadia reported net income of $4 million, or $0.02 per diluted share, compared to a net income of $19 million, or $0.11 per diluted share, for the same period in 2025. Cash and Investments At March 31, 2026, Acadia’s cash, cash equivalents, and investment securities totaled $851 million, compared to $820 million at December 31, 2025. Full Year 2026 Financial Guidance (GAAP): Acadia is reaffirming its 2026 guidance as first provided on February 25, 2026: Total revenues in the range of $1.22 to $1.28 billion. NUPLAZID net product sales in the range of $760 to $790 million. DAYBUE net product sales in the range of $460 to $490 million. R&D expense in the range of $385 to $410 million. SG&A expense in the range of $660 to $700 million. Conference Call and Webcast Information Acadia will host a conference call to discuss the first quarter 2026 results today, Wednesday, May 6, 2026 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed by registering for the call here . Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call. About NUPLAZID ® (pimavanserin) Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. About DAYBUE ® (trofinetide) Trofinetide is a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. Trofinetide was approved for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older by the U.S. Food and Drug Administration in March 2023 under the trade name DAYBUE or DAYBUE STIX. About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X . Non-GAAP Financial Measures This press release contains the following financial measures that do not comply with U.S. generally accepted accounting principles (GAAP): non-GAAP adjusted net sales for NUPLAZID for the first quarter of 2025 and non-GAAP adjusted total revenues for the first quarter of 2025. In preparing these non-GAAP financial results, the Company includes adjustments made to reflect the impact of a change in estimate related to NUPLAZID IRA rebate accruals. Please refer to our press release dated February 25, 2026, for additional details. These non-GAAP financial measures complement GAAP results and are used by management to analyze financial performance and evaluate period-to-period changes. Management believes these non-GAAP financial measures are useful to investors and other users of the Company’s financial statements to facilitate period-to-period comparability. These non-GAAP financial measures are not meant to be considered as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are unlikely to be comparable with non-GAAP disclosures released by other companies. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “guidance,” “continue” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, DAYBUE sales growth, interest in DAYBUE STIX, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for our products, including NUPLAZID and DAYBUE, and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; (iv) the timing and conduct of our clinical trials; and (v) our estimates regarding our future financial performance, profitability, capital requirements or expenses, including our full year 2026 financial guidance. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of our products and our ability to maintain or increase sales of our products; our plans to continue commercial growth; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-K for the year ended December 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law. ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2026 2025 Revenues Product sales, net $ 268,062 $ 244,317 Total revenues 268,062 244,317 Operating expenses Cost of product sales (1)(2) 24,791 20,392 Research and development (2) 76,868 78,265 Selling, general and administrative (2) 171,019 126,370 Total operating expenses 272,678 225,027 (Loss) income from operations (4,616 ) 19,290 Interest income, net 8,055 7,901 Other income 542 588 Income before income taxes 3,981 27,779 Income tax expense 344 8,792 Net income $ 3,637 $ 18,987 Earnings per share: Basic $ 0.02 $ 0.11 Diluted $ 0.02 $ 0.11 Weighted average common shares outstanding: Basic 170,517 166,808 Diluted 172,706 167,668 (1) Includes license fees and royalties (2) Includes the following stock-based compensation expense Cost of product sales $ 328 $ 334 Research and development $ 4,142 $ 3,433 Selling, general and administrative $ 10,228 $ 7,613 ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited) March 31, 2026 December 31, 2025 (unaudited) Assets Cash, cash equivalents and investment securities $ 851,458 $ 819,686 Accounts receivable, net 135,350 121,457 Interest and other receivables 13,034 26,774 Inventory 31,574 34,670 Prepaid expenses 64,600 59,526 Total current assets 1,096,016 1,062,113 Property and equipment, net 14,652 7,511 Operating lease right-of-use assets 46,274 47,354 Intangible assets, net 106,171 108,893 Restricted cash 7,846 7,845 Long-term inventory 80,719 76,704 Deferred tax assets 249,624 249,879 Other assets 3,928 3,896 Total assets $ 1,605,230 $ 1,564,195 Liabilities and stockholders’ equity Accounts payable $ 12,246 $ 10,903 Accrued liabilities 293,278 266,211 Total current liabilities 305,524 277,114 Operating lease liabilities 39,003 40,554 Other long-term liabilities 12,637 19,137 Total liabilities 357,164 336,805 Total stockholders’ equity 1,248,066 1,227,390 Total liabilities and stockholders’ equity $ 1,605,230 $ 1,564,195 Table 1. ACADIA PHARMACEUTICALS INC. NON-GAAP RECONCILIATION (in millions) (Unaudited) 1Q25 1Q26 GAAP NUPLAZID Net Sales $ 159.7 $ 166.9 Allocation of 2025 Amount $ (2.3 ) $ — Non-GAAP Adjusted NUPLAZID Net Sales $ 157.4 $ 166.9 DAYBUE Net Sales $ 84.6 $ 101.2 Non-GAAP Adjusted Total Revenues $ 242.0 $ 268.1 References Prange EO, Beisang A, Pehlivan D, et al. Expert Consensus on Real-World Use of Trofinetide for Rett Syndrome Using a Modified Delphi Method. Ann Child Neurol. 2026; 4:38-51. Contacts Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858) 261-2872 ir@acadia-pharm.com Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950 ir@acadia-pharm.com Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818) 395-3043 media@acadia-pharm.com