Pimavanserin tartrate

- 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

SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will present multiple original data presentations spanning its portfolio at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18–22, 2026 in Chicago, IL. The Company will present real-world data from a sub-group analysis of the ongoing, Phase 4, prospective, observational, open-label LOTUS study evaluating the benefits and tolerability of DAYBUE® (trofinetide) in adults with Rett syndrome in routine clinical practice. In support of NUPLAZID® (pimavanserin) in Parkinson’s disease psychosis (PDP), Acadia will present exploratory analyses evaluating heterogeneity in treatment response trajectories and the impact of baseline sleep disturbances among PDP patients treated with pimavanserin. The Company is also debuting translational and pharmacokinetic research supporting the continued development of ACP-711, an investigational drug, for essential tremor. Collectively, these data reflect Acadia’s ongoing commitment to advancing scientific knowledge across a wide range of neurological conditions. AAN Poster Presentations P11 . 005: Real-world Benefits and Tolerability of Trofinetide for the Treatment of Adults with Rett Syndrome: the LOTUS Study , Wednesday, April 22 , 11:45 AM – 12:45 PM CT P11 . 006: Response Trajectories of Patients with Parkinson’s Disease Psychosis Treated with Pimavanserin: An Exploratory Cluster Analysis , Wednesday, April 22 , 11:45 AM – 12:45 PM CT P11 . 007: Impact of Baseline Sleep Disturbances on Pimavanserin Response in Parkinson’s Disease Psychosis: A Post Hoc Analysis , Wednesday, April 22 , 11:45 AM – 12:45 PM CT P7 . 007: Development of ACP-711, a Selective Modulator of GABA-A Receptor a3, for Essential Tremor: Use of First-in-Human Phase 1 Pharmacokinetics and Pharmacodynamics to Identify Target Dose/Exposure , Tuesday, April 21 , 8:00 AM – 9:00 AM CT P8 . 012: Mechanism of Action, Preclinical Efficacy, and Safety Evaluation of ACP-711 (SAN711): A Novel GABAA Subunit a3 Selective Modulator , Tuesday, April 21 , 11:45 AM – 12:45 PM CT About DAYBUE® (trofinetide) and DAYBUE® STIX (trofinetide) Trofinetide is a synthetic analog of the N-terminal tripeptide of insulin-like growth factor-1. The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. In animal studies, trofinetide has been shown to increase branching of dendrites and synaptic plasticity signals.1 Indication and Important Safety Information for DAYBUE® (trofinetide) and DAYBUE® STIX (trofinetide) Indication DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. Important Safety Information Diarrhea: In a 12-week study and in long-term studies, 85% of patients treated with DAYBUE experienced diarrhea. In those treated with DAYBUE, 49% either had persistent diarrhea or recurrence after resolution despite dose interruptions, reductions, or concomitant antidiarrheal therapy. Diarrhea severity was mild or moderate in 96% of cases. In the 12-week study, antidiarrheal medication was used in 51% of patients treated with DAYBUE. Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should notify their healthcare provider, consider starting antidiarrheal treatment, and monitor hydration status and increase oral fluids, if needed. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected. Vomiting: In a 12-week study, vomiting occurred in 29% of patients treated with DAYBUE and in 12% of patients who received placebo . Patients with Rett syndrome are at risk for aspiration and aspiration pneumonia. Aspiration and aspiration pneumonia have been reported following vomiting in patients being treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management. Weight Loss: In the 12-week study, 12% of patients treated with DAYBUE experienced weight loss of greater than 7% from baseline, compared to 4% of patients who received placebo. In long-term studies, 2.2% of patients discontinued treatment with DAYBUE due to weight loss. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs. Adverse Reactions: The common adverse reactions (≥5% for DAYBUE-treated patients and at least 2% greater than in placebo) reported in the 12-week study were diarrhea (82% vs 20%), vomiting (29% vs 12%), fever (9% vs 4%), seizure (9% vs 6%), anxiety (8% vs 1%), decreased appetite (8% vs 2%), fatigue (8% vs 2%), and nasopharyngitis (5% vs 1%). Trofinetide, a weak inhibitor of CYP3A and an inhibitor of P-gp, can increase the plasma concentrations of CYP3A and/or P-gp substrates (e.g., loperamide), which may increase the risk of adverse reactions associated with these substrates . Closely monitor patients when DAYBUE or DAYBUE STIX is administered concomitantly with sensitive CYP3A and/or P-gp substrates for which a minimal increase in substrate plasma concentration (i.e., drugs with a narrow therapeutic index) may lead to serious adverse reactions. DAYBUE and DAYBUE STIX are not recommended for patients with severe renal impairment. DAYBUE is available as an oral solution (200 mg/mL). DAYBUE STIX for oral solution powder is available in 5,000 mg, 6,000 mg, and 8,000 mg packets. Please read the full Prescribing Information also available at DAYBUEhcp.com. 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. Indication NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Important Safety Information WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported. Warnings and Precautions: QT Interval Prolongation NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval (e.g., Class 1A antiarrhythmics, Class 3 antiarrhythmics, certain antipsychotics or antibiotics). NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval. NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval (e.g., Class 1A antiarrhythmics, Class 3 antiarrhythmics, certain antipsychotics or antibiotics). NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval. Adverse Reactions: The adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%). Coadministration with strong CYP3A4 inhibitors increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily. Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID. Dosage and Administration Recommended dose: 34 mg capsule taken orally once daily, without titration, with or without food. NUPLAZID is available as 34 mg capsules and 10 mg tablets. Please read the full Prescribing Information, including Boxed WARNING, also available at NUPLAZIDhcp.com. 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. References Acadia Pharmaceuticals Inc., Data on file. Study Report 2566-026. 2010.